Painless or minimally uncomfortable insertion ensures success of cecal intubation , current patient satisfaction , and willingness to repeat future colonoscopy with minimal sedation .


Water immersion ( WI ) and water exchange ( WE ) , when separately compared with air insufflation ( AI ) , significantly reduced insertion pain .


To assess comparative effectiveness , we conducted a randomized controlled trial with head-to-head comparison of these three methods .


We hypothesized that WE could produce the highest proportion of patients reporting painless insertion .


This prospective patient-blinded trial ( NCT01535326 ) enrolled minimally sedated ( 25mg intramuscular meperidine ) patients randomized to AI , WI , or WE ( 90 patients/group ) to aid insertion .


The previously validated primary outcome was the proportion of patients reporting painless insertion .


Painless insertion was reported by 30.0 % ( AI ) , 43.3 % ( WI ) , and 61.1 % ( WE ) of patients ( P < 0.001 ) .


Multivariate logistic regression analysis revealed that , after adjusting for gender , body mass index , abdominal compression , position change , insertion time to cecum , and length of scope at cecum , only WE was significantly associated with painless insertion compared with AI ( odds ratio ( OR ) = 0.08 , 95 % confidence interval ( CI ) = 0.03-0 .24 , P < 0.001 ) or WI ( OR = 0.14 , 95 % CI = 0.05-0 .40 , P < 0.001 ) .


Adenoma detection rate ( ADR ) in the right ( cecum and ascending ) colon was 11.1 % ( AI ) , 14.4 % ( WI ) , and 26.7 % ( WE ) ( P = 0.015 ) .


The limitations included single site study with unblinded colonoscopist and assistant .


This head-to-head comparison of AI vs. WI vs. WE confirmed that WE was superior to WI and AI , with a significantly greater proportion of patients reporting painless insertion .


The significantly higher ADR in the right colon in the WE group warrants further investigations .


One of the most common and severe complications affecting peritoneal dialysis ( PD ) patients is exit-site infection of the peritoneal catheter ; it is therefore of vital importance to prevent it .


This complication has a negative impact on the success of the technique .


In spite of this , there are no clear guidelines concerning how to take care of the exit site .


The objective of this study was to assess the efficacy of polyhexanide in preventing exit-site infection over a 12-month period .


We designed a single-center , prospective , open-labeled , randomized controlled clinical trial with parallel groups .


Requirements for participation in the study included implantation of the peritoneal catheter at least six weeks before entering the study and no infectious complications requiring either hospital admission or antibiotic treatment for at least three months before entering into the study .


Patients were randomized to be daily cured as follows : Group A : traditional care with saline serum and povidone-iodine ; and Group B : polyhexanide solution .


Exit sites were evaluated at baseline and every four to six weeks or if any event occurred , according to the Twardowski criteria .


Of the 60 included patients , 46 completed the 12-month follow-up period .


Six underwent transplantation , five died and three were transferred to hemodialysis ( HD ) .


The treatment was well tolerated , with no side effects nor abandonments due to such effects .


Throughout the study period , six patients ( 20 % ) undergoing traditional care and only two ( 6,7 % ) receiving polyhexanide developed an exit-site infection ( p = 0.032 ) .


There were a total number of 12 infections ; nine occurred in patients following the traditional approach and only three in patients treated with polyhexanide ( p = 0.037 ) .


The germs responsible for the infections were : S. aureus ( six cases ) , Corynebacterium jeikeium ( two cases ) and P. aeruginosa ( one case ) in the saline serum and povidone-iodine group and P. aeruginosa ( three cases ) in the polyhexanide group .


The mean rate of exit-site infection was 1 episode/36 .6 patient-months for the traditional care group and 1 episode/102 .7 patient-months for the polyhexanide group ( p = 0.017 ) .


Patients following the traditional treatment required fewer days to get infected than those using polyhexanide ( p = 0.033 ; log rank : 4.2 ) .


These results show that using polyhexanide is efficient for the prevention of exit-site infections .


Patients treated with this product suffer from fewer infections and need more time to become infected .


Polyhexanide application is painless , no allergies have been described and it is well tolerated by patients .


We therefore propose that it may be used routinely from now on for the care of healthy exit site .


Periprocedural ( 6 h pre - and 24 h post-angiography ) hemofiltration appears to effectively prevent contrast-induced nephropathy ( CIN ) in chronic kidney disease ( CKD ) patients undergoing coronary angiography .


However , this procedure over-uses medical resources , and the cessation of hemofiltration during coronary angiography results in persistent renal injury .


In comparison , simultaneous hemofiltration performed only during coronary angiography requires fewer medical resources and can provide instantaneous protection against CIN .


Sixty-eight CKD patients ( serum creatinine , 2.511.15 mg/dL ) undergoing coronary angiography were randomized in a 1:2 ratio to receive either periprocedural ( n = 23 ) or simultaneous ( n = 45 ) hemofiltration .


The expected CIN rate was similar for the two groups ( 41.3 % versus 40.0 % , p = 0.769 ) .


On day 3 after contrast exposure , four and seven patients in the periprocedural and simultaneous groups , respectively experienced CIN ( 17.4 % versus 15.6 % , p = 0.846 ) .


On days 5-30 , seven and three patients in the periprocedural and simultaneous groups , respectively experienced CIN ( 30.4 % versus 6.7 % , p = 0.009 ) .


The serum creatinine levels of patients in the periprocedural group transiently decreased on day 1 and persistently increased during days 5-30 compared with the simultaneous group .


This difference between the two groups in terms of creatinine levels over time was statistically significant ( F statistic = 6.830 ; p = 0.001 , by ANCOVA ) .


The cost of hemofiltration was doubled in the periprocedural group ( $ 106683 versus $ 50440 , p < 0.001 ) .


Simultaneous hemofiltration provide equal early ( day 3 ) and better late-stage ( days 5-30 ) renal protection against CIN at a significantly lower cost compared with periprocedural hemofiltration .


The purpose of this study is to evaluate the effectiveness of electromagnetic tracking in assisting CT-guided liver biopsies .


This was a single-center prospective randomized controlled trial comparing nonfluoroscopic CT-guided liver biopsy using an advance-and-scan technique with and without electromagnetic tracking .


Fifty patients with a liver lesion referred for biopsy ( women , 52 % ; mean age , 59.7 years ; mean lesion size , 3.6 cm ) were enrolled in the study and were randomly assigned to either arm .


The primary and secondary objectives were to assess and quantify differences in the number of intraprocedural scans , cumulative effective radiation dose , number of needle manipulations , and procedure time from skin-stick to the target lesion with and without assistance .


Electromagnetic tracking significantly decreased the number of scans , effective radiation dose , number of manipulations per procedure , and time from skin-stick to the target lesion .


The ratio of the number of scans ( electromagnetic tracking to control ) was 0.55 ( 95 % CI , 0.42-0 .73 ; p < 0.0001 ) .


The mean difference in effective radiation dose ( electromagnetic tracking-control ) was -4.7 mSv ( 95 % CI , -7.01 to -2.44 mSv ; p = 0.0001 ) , and the median difference was -5.1 mSv ( 95 % CI , -7.01 to -3.56 mSv ; p < 0.0001 ) .


The ratio of the number of manipulations ( electromagnetic tracking to control ) was 0.36 ( 95 % CI , 0.24-0 .54 ; p < 0.0001 ) .


The mean difference for the time from skin-stick to the target lesion was -247.6 seconds ( 95 % CI , -394.34 to -100.83 seconds ; p = 0.0014 ) and the median difference was -253.0 seconds ( 95 % CI , -325.00 to -124.00 seconds ; p = 0.0001 ) .


Electromagnetic tracking assistance has the potential to decrease the number of intraprocedural CT scans and needle manipulations and to reduce patient radiation dose during CT-guided liver biopsy .


This report from the LEADER ( Liraglutide Effect and Action in Diabetes : Evaluation of Cardiovascular Outcome Results ) trial describes baseline lipase and amylase activity in type 2 diabetic subjects without acute pancreatitis symptoms before randomization to the glucagonlike peptide analog liraglutide or placebo .


The LEADER is an international randomized placebo-controlled trial evaluating the cardiovascular safety of liraglutide in 9340 type 2 diabetic patients at high cardiovascular risk .


Fasting lipase and amylase activity was assessed at baseline , before receiving liraglutide or placebo , using a commercial assay ( Roche ) with upper limit of normal values of 63 U/L for lipase and 100 U/L for amylase .


Either or both enzymes were above the upper limit of normal in 22.7 % of subjects ; 16.6 % ( n = 1540 ) had an elevated lipase level ( including 1.2 % > 3-fold elevated ) , and 11.8 % ( n = 1094 ) had an elevated amylase level ( including 0.2 % > 3-fold elevated ) .


In multivariable regression models , severely reduced kidney function was associated with the largest effect on increasing activity of both .


However , even among subjects with normal kidney function , 12.2 % and 7.7 % had elevated lipase and amylase levels .


In this large study of type 2 diabetic patients , nearly 25 % had elevated lipase or amylase levels without symptoms of acute pancreatitis .


The clinician must take these data into account when evaluating abdominal symptoms in type 2 diabetic patients .


Exacerbations of bronchial asthma usually occur in the autumn .


To our knowledge , however , the effectiveness of drugs for preventing exacerbations of asthma in the autumn has not been studied previously , except for leukotriene receptor antagonists and Omalizmab .


This study compared the prophylactic effectiveness of suplatast tosilate with that of mequitazine in children with asthma symptoms , which is usually exacerbated in the autumn .


The study group comprised 27 children aged 2 to 15 years who required treatment for asthmatic attacks during the past year and tested positive at least for mite allergen in the preceding autumn .


The subjects were randomly assigned to receive either suplatast or mequitazine .


The primary endpoint of this study was the number of days without symptoms during the 8 weeks of treatment .


In addition , the Japanese Pediatric Asthma Control Program ( JPAC ) scores were also recorded every 2 weeks in each group .


Overall , 14 patients received suplatast , and 13 received mequitazine for 8 weeks from September through early October .


During follow-up , the number of days without symptoms and the total JPAC scores did not differ significantly between the groups .


However , as compared with weeks 1 to 2 of treatment , the mean number of days without symptoms during weeks 7 to 8 increased significantly in only the suplatast group ( 8.6 vs. 11.5 days ; p = 0.004 ) .


Our results suggest that short-term additional treatment with suplatast is useful for preventing asthma symptoms in children with asthma , which is usually exacerbated in the autumn .


The aim of this prospective randomized controlled cross sectional study was to evaluate the effect of a six month tibolone treatment in healthy postmenopausal women on biochemical CVD markers by calculating the changes of the blood serum levels of total cholesterol ( TC ) , low-density lipoprotein ( LDL ) , high-density lipoprotein ( HDL ) , triglycerides ( Tg ) , high-sensitivity C-reactive protein ( hsCRP ) , homocysteine ( Hcy ) , and endothelin-1 ( ET-1 ) at the beginning of the treatment and after six months .


Fifty-two healthy postmenopausal women were enrolled in a prospective , randomized , case-controlled outpatient trial .


Group 1 ( n = 26 ) received 2,5 mg/d tibolone for six months , while Group 2 ( n = 26 ) received no treatment .


Serum levels ofTC , LDL , HDL , Tg , hsCRP , Hcy , and ET-1 were evaluated at baseline and after six months .


The two groups did not statistically differ at baseline characteristics .


In Group 1 tibolone treatment decreased significantly TC ( p = 0.01 ) , HDL ( p < 0.001 ) , and Tg ( p < 0.001 ) serum levels while a significant increase ofhsCRP ( p < 0.001 ) was observed .


Finally no changes were noticed on LDL , Hcy , and ET-1 serum levels .


Regarding Group 2 , no changes were observed .


Short-term tibolone treatment in healthy postmenopausal women exerts a mixed action , acting beneficially in some markers ( TC , LDL , Tg , Hcy , and ET-1 ) where as detrimentally in others ( HDL , hsCRP ) .


Few previous studies have examined the influence of instrumental and emotional social support on physical activity ( PA ) longitudinally in underserved adolescents .


This longitudinal study was a secondary analysis of the Active by Choice Today ( ACT ) trial examining whether instrumental social support predicts increases in PA in underserved adolescents , above and beyond emotional social support provided by family or peers .


Students in the sixth grade ( N = 1,422 , 73 % African American , 54 % female , M age = 11years ) in the ACT trial participated .


At baseline and 19weeks , previously validated measures of social support ( family instrumental , family emotional , and peer emotional ) were completed and moderate-to-vigorous PA ( MVPA ) was assessed using 7-day accelerometry estimates .


A mixed ANCOVA demonstrated that baseline ( p = 0.02 ) and change in family instrumental support ( p = 0.01 ) , but not emotional support from family or peers , predicted increases in MVPA across a 19-week period .


Future interventions in underserved adolescents should enhance opportunities for instrumental support for PA. .


We aimed to determine whether head elevation during combined spinal-epidural anesthesia ( CSE ) and Caesarean section provided improved hemodynamics and appropriate sensory block height .


Forty-four parous women undergoing CSE for elective Caesarean section were randomly assigned to one of two groups : right lateral ( group L ) or right lateral and head elevated ( group HE ) position , for insertion of the block .


Patients were positioned in the supine wedged position ( group L ) or the left lateral and head elevated position ( group HE ) until a block height of T5 to light touch was reached .


Group HE was then turned to the supine wedged position with maintenance of head elevation until the end of surgery .


Hemodynamics , including the incidence of hypotension , ephedrine dose required , and characteristics of the sensory blocks were analyzed .


The incidence of hypotension ( 16 versus 7 , p = 0.0035 ) and the required dose of ephedrine [ 24 ( 0-40 ) versus 0 ( 0-20 ) , p < 0.0001 ] were greater in group L compared to group HE .


In group L , the time to achieve maximal sensory block level ( MSBL ) was shorter ( 11.85.4 min versus 20.16.3 min , p < 0.0001 ) and MSBL was also higher than in group HE [ 14 ( T2 ) versus 12 ( T4 ) , p = 0.0015 ] .


Head elevation during CSE and Caesarean section is superior to positioning without head elevation in the lateral to supine position , as it is associated with a more gradual onset , appropriate block height , and improved hemodynamics .


Self-monitoring is reported to have limited efficacy for hypertension management in high-income countries .


In this study , we aimed to evaluate the effect of self-monitoring on blood pressure ( BP ) control in an Iranian population .


A randomized controlled trial was conducted on 196 mild to moderate hypertensive patients in an outpatient cardiovascular clinic .


Patients in the intervention group received a wrist self-monitoring device and were educated to measure and document their BP daily during the study period ( 24 weeks ) .


Patients in the control group received usual care .


Three follow-up visits with the physician were scheduled for all patients ( weeks 4 , 12 , and 24 ) , and the investigator assessed adherence to medications after each visit ( pill counting ) .


The primary outcome ( BP ) was compared between groups using repeated-measure analysis of variance .


One hundred ninety patients completed the study .


Systolic BP ( 144.47.4 vs 145.96.4 mm Hg ) and diastolic BP ( 85.56.9 vs. 85.17.7 mm Hg ) were similar between groups at baseline .


The trend of BP was not significantly different between groups during the study period .


Systolic and diastolic BP decreased significantly in both groups at the first follow-up visit ( systolic BP : 132.6 vs. 133.4 mm Hg ; diastolic BP : 77.4 vs. 77.2 mm Hg ) .


In the intervention group , we observed a small continued decrease in diastolic BP up to week 24 BP ( P = 0.01 ) .


Both groups showed adherence rates > 95 % during the study period .


Our study could not confirm that self-monitoring can improve BP control in patients with frequent medical visits .


To explore in a panel of patient-derived xenograft models of human non-small cell lung cancer ( NSCLC ) whether high EGFR expression , was associated with cetuximab activity .


NSCLC patient-derived xenograft models ( n = 45 ) were implanted subcutaneously into panels of nude mice and randomization cohorts were treated with either cetuximab , cisplatin , cisplatin plus cetuximab , vehicle control , or else were left untreated .


Responses according to treatment were assessed at week 3 by analyzing the relative change in tumor volume and an experimental analogue of the Response Evaluation Criteria in Solid Tumors ( RECIST ) guidelines .


An EGFR IHC score was calculated for each patient-derived xenograft model and response was assessed according to EGFR expression level .


When tumors were stratified into high and low EGFR expression groups ( IHC score threshold 200 ; scale 0-300 ) , a stronger antitumor activity was seen in the high EGFR expression group compared with the low EGFR expression group in both the cetuximab monotherapy and cisplatin plus cetuximab combination therapy settings .


For tumors treated with cisplatin plus cetuximab , the objective response rate was significantly higher in the high EGFR expression group compared with the low EGFR expression group ( 68 % vs. 29 % ) .


Objective response rates were similar in high and low expression groups for tumors treated with cisplatin alone ( 27 % vs. 24 % , respectively ) .


Cetuximab activity in NSCLC patient-derived xenograft models was demonstrated clearly only in tumors that expressed high levels of EGFR , as defined by an IHC score of 200 .


Outcome measures of breast reconstruction have used panel assessment of photographs .


This provides limited information to the assessor as these images are static .


The aim of this study was to assess whether the use of digital video was a valid assessment tool and to compare its use against photography .


35 patients post-reconstruction underwent photography , digital video capture and completed Breast Cancer Treatment Outcomes Scale ( BCTOS ) questionnaires .


The photographs/video clips were randomised and shown to a 21 member panel .


Opinions on aesthetic aspects of the reconstruction were assessed using the BCTOS and Harris scale .


Panel inter-rater agreement and patient-panel correlation was assessed using Kendall 's Coefficient of Concordance and Spearman 's rank correlation tests respectively .


There was a `` moderate '' degree of inter-rater agreement amongst panel members in all categories .


Greater agreement occurred using video footage to assess overall cosmesis ( 0.548 vs 0.507 ) and shape ( 0.505 vs 0.486 ) .


Video showed a greater degree of correlation with patient self-assessment scores in comparison to photography ( 0.311 vs 0.281 ) .


Video footage coupled with panel assessment is a valid method of assessing post-operative outcomes of breast reconstruction and appears superior to still photographs in terms of inter-rater agreement and correlation with patient self-assessment .


This study was carried out to investigate the effect of vitamins E and C on cognitive performance among the elderly in Iran .


About 256 elderly with mild cognitive impairment , aged 60-75 years , received 300 mg of vitamin E plus 400 mg of vitamin C or placebo daily just for 1 year .


Demographic characteristics , anthropometric variables food consumption , cognitive function by Mini-Mental State Examination ( MMSE ) , and some of the oxidative stress biomarkers were examined .


Antioxidant supplementation reduced malondialdehyde level ( P < 0.001 ) and raised total antioxidant capacity ( P < 0.001 ) and glutathione ( P < 0.01 ) .


The serum 8-hydroxydeoxyguanosine remained unchanged ( P < 0.4 ) .


After adjusting for the covariates effects , MMSE scores following 6 - ( 25.88 0.17 ) and 12-month antioxidant supplementation ( 26.8 0.17 ) did not differ from control group ( 25.86 0.18 and 26.59 0.18 , respectively ) .


Despite significant improvement in most of the oxidative stress biomarkers , antioxidants ' supplementation was not observed to enhance cognitive performance .


A large number of kinetic and/or dynamic factors could be suspected .


Resorbable fixation material is an attractive option for those patients undergoing orthognathic surgery .


The efficacy of resorbable screws was tested in bilateral mandibular sagittal split osteotomies ( BSSOs ) performed for correction of retrognathic mandibles .


One hundred one patients were enrolled in this prospective randomized clinical trial .


Patients in group 1 ( n = 51 ) received titanium screws ( Stryker ) and patients in group 2 ( n = 50 ) received resorbable screws ( Inion CPS ) .


Outcome measurements were compared for statistical significance .


There was a statistically significant difference in the use of postoperative elastics ( P < .0001 ) .


There was no statistically significant difference in other outcome measurements , including clinical evidence of relapse .


Resorbable screws can be used effectively for fixation of BSSO for mandibular advancement .


A higher incidence of rotation around positional screws can result secondary to the mechanical `` looseness '' when using resorbable screws .


This can be treated effectively using Class III mechanic elastics during the initial stages of bone healing .


We sought to determine whether exclusion of infection and antibiotic stewardship with the infection biomarker procalcitonin improves outcomes in congestive heart failure ( CHF ) patients presenting to emergency departments with respiratory symptoms and suspicion of respiratory infection .


We performed a secondary analysis of patients with a past medical history of CHF formerly included in a Swiss multicenter randomized-controlled trial .


The trial compared antibiotic stewardship according to a procalcitonin algorithm or state-of-the-art guidelines ( controls ) .


The primary endpoint was a 30-day adverse outcome ( death , intensive care unit admission ) ; the secondary endpoints included a 30-day antibiotic exposure .


In the 110/233 analyzed patients ( 47.2 % ) with low initial procalcitonin ( < 0.25 g/L ) , suggesting the absence of systemic bacterial infection , those randomized to procalcitonin guidance ( n = 50 ) had a significantly lower adverse outcome rate compared to controls ( n = 60 ) : 4 % vs. 20 % ( absolute difference -16.0 % , 95 % confidence interval ( CI ) -28.4 % to -3.6 % , P = 0.01 ) , and significantly reduced antibiotic exposure [ days ] ( mean 3.7 4.0 vs. 6.5 4.4 , difference -2.8 [ 95 % CI , -4.4 to -1.2 ] , P < 0.01 ) .


When initial procalcitonin was 0.25 g/L , procalcitonin-guided patients had significantly reduced antibiotic exposure due to early stop of therapy without any difference in adverse outcomes ( 25.8 % vs. 24.6 % , difference [ 95 % CI ] 1.2 % [ -14.5 % to 16.9 % , P = 0.88 ] ) .


CHF patients presenting to the emergency department with respiratory symptoms and suspicion for respiratory infection had decreased antibiotic exposure and improved outcomes when procalcitonin measurement was used to exclude bacterial infection and guide antibiotic treatment .


These data provide further evidence for the potential harmful effects of antibiotic / fluid treatment when used instead of diuretics and heart failure medication in clinically symptomatic CHF patients without underlying infection .


Children surviving acute lymphoblastic leukemia ( ALL ) are at increased risk for overweight and obesity over that of the general population .


Whether a generic or tailored approach to weight management is needed for cancer survivors has yet to be tested .


Thirty-eight youth 8-18 years with BMI 85 % who had survived ALL were recruited for a randomized clinical trial evaluating a weight management intervention ( WMI ) tailored for childhood ALL survivors ( Fit4Life ) .


Fit4Life recipients received a 4-month web , phone , and text message-delivered WMI tailored for cancer survivorship .


Controls received a general WMI delivered via phone and mail .


Assessments were performed at baseline and 4 months .


Outcome data were analyzed according to assigned treatment condition over time .


Most ( 80 % , ( 70 % , 100 % ) [ median ( IQR ) ] ) of the assigned curriculum was received by Fit4Life participants as compared to 50 % ( 40 % , 65 % ) among controls .


Fit4Life recipients 14 years demonstrated less weight gain ( P = 0.05 ) and increased moderate-to-vigorous physical activity ( P < 0.01 ) while all Fit4Life recipients reported reduced negative mood ( P < 0.05 ) over time as compared to control counterparts .


We demonstrated acceptable feasibility of a WMI tailored for overweight and obese children surviving ALL utilizing a multimodal technology approach .


Improved weight , weight-related behavior , and psychological outcomes were demonstrated among Fit4Life intervention as compared to youth receiving a generic WMI .


Data from this pilot trial may be used to design a larger trial to determine whether youth of all ages also can derive a benefit from a cancer survivor-tailored WMI and whether short-term outcomes translate into improved long-term outcomes for childhood ALL survivors .


Patient self-management support may be augmented by using home-based technologies that generate data points that providers can potentially use to make more timely changes in the patients ' care .


The purpose of this study was to evaluate the effectiveness of short-term targeted use of remote data transmission on treatment outcomes in patients with diabetes who had either out-of-range hemoglobin A1c ( A1c ) and/or blood pressure ( BP ) measurements .


A single-center randomized controlled clinical trial design compared in-home monitoring ( n = 55 ) and usual care ( n = 53 ) in patients with type 2 diabetes and hypertension being treated in primary care clinics .


Primary outcomes were A1c and systolic BP after a 12-week intervention .


There were no significant differences between the intervention and control groups on either A1c or systolic BP following the intervention .


The addition of technology alone is unlikely to lead to improvements in outcomes .


Practices need to be selective in their use of telemonitoring with patients , limiting it to patients who have motivation or a significant change in care , such as starting insulin .


Attention to the need for effective and responsive clinic processes to optimize the use of the additional data is also important when implementing these types of technology .


It is empirically well documented that psychotherapy is vital in the treatment of chronic back pain .


To test in this randomized controlled clinical trial whether cognitive behavior group therapy is effective in respect to pain tolerance and disability apart from the effects on somatization in general and additional to the effects of a multimodal inpatient orthopedic rehabilitation programme .


Fifty-three patients were randomly assigned to an intervention group , receiving six sessions of `` cognitive behavior group therapy for back pain '' ( CBT-BP ) , and 50 to a control group who got unspecific occupational therapy sessions instead .


Patients were suffering from chronic back pain for at least six months .


All patients were treated for 21 days in an orthopedic inpatient rehabilitation unit with a multimodal orthopedic treatment , including active physical therapy , patient education or motivation to exercise .


In both groups there is a significant improvement over time in the Symptom Checklist ( SCL-90 ) , the Rating of Health Locus of Control Attributions , the Fear Avoidance Beliefs Questionnaire ( FABQS ) and a Visual Analogue Pain Scale ( VAS-pain ) .


There are significant interactions between treatment group and VAS-pain and the FABQS , showing a superior improvement in the intervention group , while no significant superiority is found for the SCL .


The experience of pain can be altered directly and not only through improvement of depression or general somatoform complaints .


The study replicates other research and increases the evidence base for this mode of treatment .


The treatment effect can be called specific as it is found additional to a multimodal inpatient care programme .


To investigate whether the 2-year change in lens opacity severity on the Age-Related Eye Disease Study ( AREDS ) lens grading scale predicts progression to cataract surgery or loss of visual acuity by 5 years .


Prospective cohort study within a randomized clinical trial of oral supplements .


The AREDS participants whose eyes were phakic at baseline and free of late age-related macular degeneration throughout the study .


Baseline and annual lens photographs of AREDS participants ( n = 3466/4757 ; 73 % ) were graded for severity of cataracts using the AREDS system for classifying cataracts from photographs .


Clinical examinations conducted semiannually collected data on cataract surgery and visual acuity .


Association of the change in lens opacities at 2 years with these outcomes at 5 years was analyzed with adjusted Cox proportional hazard models .


Progression of lens opacities on stereoscopic lens photographs at 2 years , cataract surgery , and visual acuity loss of 2 lines or more at 5 years .


The adjusted hazard ratios ( HRs ) for association of progression to cataract surgery at 5 years were : nuclear cataract increase of 1.0 unit or more compared with less than 1.0-unit change at 2 years , 2.77 ( 95 % confidence interval [ CI ] , 2.07-3 .70 ; P < 0.001 ) ; cortical cataract increase of 5 % or more in lens opacity in the central 5 mm of the lens compared with less than 5 % increase at 2 years , 1.91 ( 95 % CI , 1.27-2 .87 ; P = 0.002 ) ; and posterior subcapsular cataract increase of 5 % or more versus less than 5 % in the central 5 mm of the lens , 8.25 ( 95 % CI , 5.55-12 .29 ; P < 0.001 ) .


Similarly , HRs of vision loss of 2 lines or more at 5 years for this degree of lens changes at 2 years were the following : nuclear , 1.83 ( 95 % CI , 1.49-2 .25 ; P < 0.001 ) ; cortical , 1.13 ( 95 % CI , 0.78-1 .65 ; P = 0.519 ) ; and posterior subcapsular cataract , 3.05 ( 95 % CI , 1.79-5 .19 ; P < 0.001 ) .


Two-year changes in severity of lens opacities on the AREDS lens grading scale are predictive of long-term clinically relevant outcomes , making them potential surrogate end points in follow-up studies .


Angiotensin receptor blockers ( ARBs ) inhibit activated hepatic stellate cell contraction and are thought to reduce the dynamic portion of intrahepatic resistance .


This study compared the effects of combined treatment using the ARB candesartan and propranolol versus propranolol monotherapy on portal pressure in patients with cirrhosis in a prospective , randomized controlled trial .


Between January 2008 and July 2009 , 53 cirrhotic patients with clinically significant portal hypertension were randomized to receive either candesartan and propranolol combination therapy ( 26 patients ) or propranolol monotherapy ( 27 patients ) .


Before and 3 months after the administration of the planned medication , the hepatic venous pressure gradient ( HVPG ) was assessed in both groups .


The dose of propranolol was subsequently increased from 20 mg bid until the target heart rate was reached , and the candesartan dose was fixed at 8 mg qd .


The primary endpoint was the HVPG response rate ; patients with an HVPG reduction of > 20 % of the baseline value or to < 12 mmHg were defined as responders .


The mean portal pressure declined significantly in both groups , from 16 mmHg ( range , 12-28 mmHg ) to 13.5 mmHg ( range , 6-20 mmHg ) in the combination group ( P < 0.05 ) , and from 17 mmHg ( range , 12-27 mmHg ) to 14 mmHg ( range , 7-25 mmHg ) in the propranolol monotherapy group ( P < 0.05 ) .


However , the medication-induced pressure reduction did not differ significantly between the two groups [ 3.5 mmHg ( range , -3 -11 mmHg ) vs. 3 mmHg ( range , -8 -10 mmHg ) , P = 0.674 ] .


The response rate ( 55.6 % vs. 61.5 % , P = 0.435 ) and the reductions in mean blood pressure or heart rate also did not differ significantly between the combination and monotherapy groups .


The addition of candesartan ( an ARB ) to propranolol confers no benefit relative to classical propranolol monotherapy for the treatment of portal hypertension , and is thus not recommended .


Repeat infection with Chlamydia trachomatis is common and increases the risk of sequelae in women and HIV seroconversion in men who have sex with men ( MSM ) .


Despite guidelines recommending chlamydia retesting three months after treatment , retesting rates are low .


We are conducting the first randomised controlled trial to assess the effectiveness of home collection combined with short message service ( SMS ) reminders on chlamydia retesting and reinfection rates in three risk groups .


The REACT ( retest after Chlamydia trachomatis ) trial involves 600 patients diagnosed with chlamydia : 200 MSM , 200 women and 200 heterosexual men recruited from two Australian sexual health clinics where SMS reminders for retesting are routine practice .


Participants will be randomised to the home group ( 3-month SMS reminder and home-collection ) or the clinic group ( 3-month SMS reminder to return to the clinic ) .


Participants in the home group will be given the choice of attending the clinic if they prefer .


The mailed home-collection kit includes a self-collected vaginal swab ( women ) , UriSWAB ( Copan ) for urine collection ( heterosexual men ) , and UriSWAB plus rectal swab ( MSM ) .


The primary outcome is the retest rate at 1-4 months after a chlamydia diagnosis , and the secondary outcomes are : the repeat positive test rate ; the reinfection rate ; the acceptability of home testing with SMS reminders ; and the cost effectiveness of home testing .


Sexual behaviour data collected via an online survey at 4-5 months , and genotyping of repeat infections , will be used to discriminate reinfections from treatment failures .


The trial will be conducted over two years .


An intention to treat analysis will be conducted .


This study will provide evidence about the effectiveness of home-collection combined with SMS reminders on chlamydia retesting , repeat infection and reinfection rates in three risk groups .


The trial will determine client acceptability and cost effectiveness of this strategy .


Australian and New Zealand Clinical Trials Registry ACTRN12611000968976 .


Blueberries are a rich source of flavonoids and phenolic acids .


Currently , little information is available regarding the impact of processing on the bioavailability and the bioactivity of blueberry ( poly ) phenols .


In a randomized , controlled crossover trial , ten healthy volunteers consumed ( a ) blueberry-containing baked products , ( b ) an unprocessed blueberry drink containing the same amount of freeze-dried blueberry powder as used in the baked products , and ( c ) matched control baked products .


Endothelial function was measured as flow-mediated dilation ( FMD ) and plasma samples taken at baseline and at 1 , 2 , 4 , and 6 h postconsumption .


Although processing did not significantly change the total ( poly ) phenolic amount , the processed products contained significantly less anthocyanins ( -42 % ) , more chlorogenic acid ( 23 % ) , no flavanol nonamers or decamers , and significantly more flavanol dimers and trimers ( 36 % and 28 % , respectively ) .


FMD increased after 1 , 2 , and 6 h consumption of the baked products to a similar degree as the unprocessed blueberries , despite significant differences in the levels of individual plasma metabolites .


No changes were observed after the consumption of the control product .


Careful processing can preserve important biological activities of blueberries despite changing the blueberry ( poly ) phenol composition and plasma metabolite profile .


The aim of this study was to investigate safety , tolerance , relative exercise intensity , and muscle substrate oxidation during sessions performed on a Huber Motion Lab in coronary heart disease patients .


After an assessment of Vo2 peak , 20 coronary heart disease patients participated in two different exercises performed in random order at 40 % and 70 % ( W40 and W70 ) of the maximal isometric voluntary contraction .


No significant arrhythmia or abnormal blood pressure responses occurred during either session , and no muscle soreness was reported within 48 hrs posttest .


The authors found a difference between W40 and W70 sessions for mean ( standard deviation ) ventilation ( 25.1 % [ 8 % ] and 32.1 % [ 9 % ] of maximal ventilation , respectively ; P = 0.04 ) and a small difference for mean ( standard deviation ) heart rate ( 73 [ 7 ] and 79 [ 8 ] beats/min , respectively ; P < 0.01 ) .


When compared with the W40 , the W70 was associated with higher active energy expenditure ( 2.4 [ 0.6 ] and 3.1 [ 0.9 ] Kcal/min , respectively ; P < 0.0001 ) and a similar mean ( standard deviation ) oxygen uptake ( 5.5 [ 1 ] and 6.6 [ 1 ] ml/min per kilogram , respectively ; P = 0.07 ) .


The qualitative percentages of carbohydrates and lipids oxidized were 71 % and 29 % , respectively , at W40 and 91 % and 9 % , respectively , at W70 .


Both protocols , which consisted of repeating 6-sec phases of contractions with 10 secs of passive recovery on the Huber Motion Lab , seemed to be well tolerated , safe , and feasible in this group of coronary heart disease patients .


To observe the impacts on endometrial and pregnancy outcomes treated with acupuncture and moxibustion in the patients of in vitro fertilization-embryo transfer ( IVF-ET ) and explore the application value , of acupuncture and moxibustion in IVF-ET treatment .


One hundred and fourteen patients of IVF-ET treated with standard long-term program at luteal phase were randomized into an observation group and a control group , 57 cases in each one .


In the observation group , at the beginning of ovulatory induction , moxibustion was applied to Shenque ( CV 8 ) and acupuncture was to Zhongji ( CV 3 ) , Guanyuan ( CV 4 ) , Qihai ( CV 6 ) , Zigong ( EX-CA 1 ) , Xuebai ( SP 10 ) , etc. till the transfer time for one session of treatment .


Totally , 3 sessions were required .


In the control group , no intervention of acupuncture and moxibustion was applied .


The endometrial morphology , subendometrial blood flow index , the levels of serum estradiol ( E2 ) , progesterone ( P ) and luteinizing hormone ( LH ) on the day of injection of human chorionic gonadotropin ( hCG ) , the dosage and time of gonadotropin ( Gn ) , oocyte count , high-quality embryo number , embryo cultivation rate and clinical pregnant rate were observed in the two groups .


The A type endometrial proportion on hCG day and high-quality embryo rate in the observation group were higher than those in the control group , indicating the significant differences ( both P < 0.05 ) .


The difference in endometrial thickness on hCG day was not significant between the two groups ( P > 0.05 ) .


In the observation group , endometrial hemodynamic index ( peak systolic blood velocity/end-diastolic blood velocity , S/D ) , resistive index ( RI ) and pulse index ( PI ) were lower than those in the control group ( P < 0.01 , P < 0.05 ) .


The levels of serum E2 and P on hCG day in the observation group were higher than those in the control group ( both P < 0.05 ) .


The differences were not significant in Gn dose , Gn medication time , numbers of follicles > 1.6 cm on hCG day , oocyte count , embryo cultivation rate and clinical pregnancy rate and LH level on hCG day between the two groups ( all P > 0.05 ) .


In IVF-ET treatment , acupuncture and moxibustion affect estrogen level on hCG day , improve high-quality embryo rate , endometrial blood flow state and morphology so that the endometrial receptivity is increased and the method is expected to be the assistant therapeutic approach for the improvement of IVF-ET outcome .


The pilot study purpose was to determine the effects of a new standardized oral care protocol ( intervention ) to usual care practices ( control ) in poststroke patients .


This study is a randomized controlled clinical trial .


Fifty-one subjects were enrolled .


Subjects in the intervention group received oral care twice a day including tooth brushing , tongue brushing , flossing , mouth rinse , and lip care while control patients received usual oral care .


Subjects in the control and intervention groups showed improvement in their oral health assessments , swallowing abilities and oral intake .


There were no significant differences between the two groups .


Although not statistically significant , overall prevalence of methicillin-resistant Staphylococcus aureus and methicillin-sensitive Staphylococcus aureus colonization in the control group almost doubled ( from 4.8 % to 9.5 % ) , while colonization in the intervention group decreased ( from 20.8 % to 16.7 % ) .


These findings demonstrate the importance of oral care in the poststroke patient with dysphagia .


The current study assessed relations among maternal depressive symptoms , poorer youth diabetes adherence , and glycemic control .


Specifically , hypothesized mediating links of lowered expectations of parental involvement , less parental monitoring , and more conflict were examined .


Participants included 225 mothers and their young adolescents , aged 11-14 years ( M = 12.73 years , SD = 1.2 ) diagnosed with T1D .


Maternal depressive symptoms and outcome expectancies for maternal involvement were evaluated with self-report questionnaires .


Multisource , parent/youth , and multimethod assessment of adherence , parental monitoring , and conflict were evaluated during a baseline assessment from a larger randomized clinical trial .


The first hypothesized structural equation model demonstrated a good fit and indicated that more maternal depressive symptoms were directly associated with less parental monitoring and more conflict , which in turn each were associated with poorer adherence and glycemic control .


Although higher involvement expectancies were associated with more monitoring and less conflict , they were not associated with other model variables .


A second alternative model also fit the data well ; poorer youth adherence was associated with more conflict that in turn related to maternal depressive symptoms .


Two models were tested by which maternal depressive symptoms and poorer youth adherence were interrelated via less monitoring and more conflict .


Follow-up longitudinal evaluation can best characterize the full extent of these relations .


To evaluate the effectiveness of specialized physiotherapy methods measured by the BODE index in patients with COPD during hospitalization .


The study was conducted on a group of 30 patients diagnosed with COPD , all under treatment at the clinical hospital in Wroclaw due to the exacerbation of their symptoms .


All patients were undergoing standard pharmacological treatment along with basic physiotherapy .


The subjects of the study were randomly divided between an experimental group of 20 persons and a control group of 10 persons .


Patients in the experimental group underwent a series of 6 additional massage treatments performed over a period of a few days , aimed at reshaping the following muscles : the sterno-cleidomastoid , pectoralis major , pectoralis minor , trapezius , levator scapulae , rhomboids and serratus anterior .


Each massage lasted for 30 minutes and consisted of stroking , grinding , vibration and kneading techniques .


Before and after therapy the patients were assessed based on the BODE index .


First , the patient 's BMI was calculated ( B ) .


Airflow obstruction ( O ) was determined by the percentage value of FEV1 while the MRC scale was used to evaluate a patient 's dyspnea ( D ) .


Exercise capacity ( E ) was measured by the distance a patient could cover in a 6-minute walk test .


Each variable of the BODE index was ranked on a scale from 0 to 3 points except the BMI , for which was given either 0 or 1 point .


Analysis of the results showed a significant improvement of the BODE index in the experimental group while in the control group this ratio changed slightly .


The FEV1 and MRC parameters changed significantly only in the experimental group .


After a week of therapy the BODE index improved in both groups , but in the experimental group there was a significantly higher difference .


In the experimental group all BODE components except BMI improved highly significantly , whereas in the control group only exercise capacity was significantly improved .


The gold standard in ACL reconstructions has been the bone-patellar tendon-bone autograft fixed with interference screws .


This prospective , randomized clinical trial aimed to compare two methods of fixation for BPTB grafts : press-fit fixation vs. interference screw , over a 12-month follow-up interval .


158 patients with an average age of 29.8 years , between 2011 and 2012 , were treated for torn ACL .


82 patients underwent reconstruction with BPTB autograft with a press fit fixation technique , and in 76 cases an interference screw was used .


At the time of final follow-up , 71 patients in press-fit group and 65 patients in interference screw group were evaluated in terms of return to pre-injury activity level , pain , knee stability , range of motion , IKDC score and complications .


At 12-month follow-up , 59 ( 83 % ) and 55 ( 85 % ) in press-fit and screw group , respectively had good-to-excellent IKDC score ( p > 0.05 ) .


The mean laxity assessed using a KT-1000 arthrometer improved to 2.7 and 2.5 mm in press-fit and screw group , respectively .


Regarding Lachman and pivot shift test , there was a statistically significant improvement in the integrity of the ACL in both the groups , but no significant differences was noted between groups .


There were no significant differences in terms of femur circumference difference , effusion , knee range of motion , pain and complications .


The press-fit technique is an efficient procedure .


Its outcome was comparable with the interference screw group .


Furthermore it has unlimited bone-to-bone healing , no need for removal of hardware , ease for revision and cost effectiveness .


When used with standard diagnostic testing , point-of-care ultrasonography might improve the proportion of patients admitted with respiratory symptoms who are correctly diagnosed 4 h after admission to the emergency department .


We therefore assessed point-of-care ultrasonography of the heart , lungs , and deep veins in addition to the usual initial diagnostic testing in this patient population .


In a prospective , parallel-group trial in the emergency department at Odense University Hospital , Odense , Denmark , patients ( 18 years ) with a respiratory rate of more than 20 per min , oxygen saturation of less than 95 % , oxygen therapy , dyspnoea , cough , or chest pain were randomly assigned in a 1:1 ratio with a computer-generated list to a standard diagnostic strategy ( control group ) or to standard diagnostic tests supplemented with point-of-care ultrasonography of the heart , lungs , and deep veins ( point-of-care ultrasonography group ) .


The primary endpoint was the percentage of patients with a correct presumptive diagnosis 4 h after admission to the emergency department .


Only the physicians doing the primary clinical assessment and the auditors were masked .


Analyses were by intention to treat .


The study is registered with ClinicalTrials.gov , number NCT01486394 .


Between Dec 7 , 2011 , and March 15 , 2013 , 320 patients were randomly assigned to the control group ( n = 160 ) and point-of-care ultrasonography group ( n = 160 ) .


158 patients in the point-of-care ultrasonography group and 157 in the control group were analysed .


4 h after admission to the emergency department , 139 patients ( 880 % ; 95 % CI 828-931 ) in the point-of-care ultrasonography group versus 100 ( 637 % ; 561-713 ) in the control group had correct presumptive diagnoses ( p < 00001 ) .


The absolute and relative effects were 243 % ( 95 % CI 150-331 ) and 138 ( 101-131 ) , respectively .


No adverse events were reported .


Point-of-care ultrasonography is a feasible , radiation free , diagnostic test , which alongside standard diagnostic tests is superior to standard diagnostic tests alone for establishing a correct diagnosis within 4 h.


It should therefore be considered for routine use as part of the standard diagnostic tests in the emergency department for patients admitted with respiratory symptoms .


University of Southern Denmark , Odense University Hospital , and Hjbjerg Fund .


The purpose of the current study is to examine the efficacy of Counselor-Assisted Problem Solving ( CAPS ) in improving caregiver adaptation following traumatic brain injury ( TBI ) .


In a randomized clinical trial comparing CAPS ( n = 65 ) , an online problem-solving intervention with accompanying Web-based counseling sessions , with an information-based Internet Resource Comparison ( IRC ; n = 67 ) program , participants included families of 12 - to 17-year-olds who had sustained a TBI in the past 6 months .


Linear regression analyses were used to identify main effects and to examine whether caregiver education , race , or prior computer use moderated treatment efficacy .


Computer experience moderated postintervention improvements in caregiving self-efficacy following CAPS , Specifically , parents in CAPS with low levels of prior use reporting the greatest improvements .


CAPS participants who completed 5 or more sessions reported greater reductions in depression than did the IRC ; however , the groups did not differ on global distress .


Findings support the potential utility of counselor-supported Web-based interventions particularly for individuals with limited computer expertise following adolescent TBI .


Digital plain radiographs of the pelvis are frequently performed in follow-up examinations of patients who received total hip arthroplasty ( THA ) or osteosynthesis ( OS ) .


Thus , the purpose was to reduce the radiation dose and to determine objective quality control criteria to ensure accurate assessment .


Institutional review board approval was obtained .


In this prospective randomized study , 289 patients underwent X-ray examination of the pelvis as follow up after receiving THA or OS with standard and reduced dose .


The evaluation of the plain radiographs was conducted using the following criteria : bone-implant interface , implant-implant discrimination , implant-surface character and periarticular heterotopic ossification .


Two radiologists evaluated these criteria using a score ranging from 1 ( definitely assessable ) to 4 ( not assessable ) .


If a single criterion had been evaluated with a score of 3 or more or more than 2 criteria with 2 points , the radiograph was scored as `` not assessable '' .


The study was designed as non-inferiority-trial .


Seven ( 2.4 % ) examined X-rays were scored as not assessable .


There was no statistical inferiority between the examinations with standard ( 0.365 mSv ) or reduced dose ( 0.211 mSv ) .


Reduced dose only led to limitations in the evaluation of ceramic components with low clinical impact in most scenarios .


Plain radiography of the pelvis in patients with THA or OS can be performed with a dose reduction of about 42 % without a loss of important information .


The obtained quality control criteria were clinically applicable .


We developed a tailored education program using a touch-screen computer for changing management behavior with asthmatic children and their caregivers .


The purpose of this study was to examine the effect of the tailored education program .


Caregivers including children with asthma were recruited during visits to a national children 's hospital and those whose month-long asthma condition on the JPAC ( Japanese Pediatric Asthma Program ) score was 14 and below were included .


Caregivers were randomized to the tailored education ( intervention group ) or non-tailored education ( control group ) .


The intervention group underwent a patient education program using a touch-screen computer , and they received tailored messages generated by a computer program .


A research nurse and clinical psychologist used a computer-based resource to tailor the education messages and provided counseling using motivational interviewing for the caregivers including children with asthma .


The control group received only a booklet on asthma .


Forty-seven subjects aged 1 to 6 years were enrolled .


Forty-seven caregivers were randomized to the tailored education ( n = 22 ) or non-tailored education ( n = 25 ) group .


The results of two-way ANOVA showed that interactions between groups were observed in the score of JPAC and asthma knowledge for preschool children whose asthma onset was within one year and a half .


The main effects of time were observed in the total and subscale score of QOL ( Quality of Life ) and the total score of P-CASES ( Parental Childhood Asthma 's Self-efficacy Scale ) .


These findings indicate the benefit of a tailored education program to control symptoms in such caregivers .


( R , S ) - ketamine produces rapid and significant antidepressant effects in approximately 65 % of patients suffering from treatment-resistant bipolar depression ( BD ) .


The genetic , pharmacological and biochemical differences between ketamine responders and non-responders have not been identified .


The purpose of this study was to employ a metabolomics approach , a global , non-targeted determination of endogenous metabolic patterns , to identify potential markers of ketamine response and non-response .


Plasma samples from 22 BD patients were analyzed to produce metabolomic patterns .


The patients had received ketamine in a placebo-controlled crossover study and the samples were obtained 230min post-administration at which time the patients were categorized as responders or non-responders .


Matching plasma samples from the placebo arm of the study were also analysed .


During the study , the patients were maintained on either lithium or valproate .


The metabolomic patterns were significantly different between the patients maintained on lithium and those maintained on valproate , irrespective of response to ketamine .


In the patients maintained on lithium , 18 biomarkers were identified .


In responders , lysophosphatidylethanolamines ( 4 ) and lysophosphatidylcholines ( 9 ) were increased relative to non-responders .


The results indicate that the differences between patients who respond to ketamine and those who do not are due to alterations in the mitochondrial - oxidation of fatty acids .


These differences were not produced by ketamine administration .


The data indicate that pretreatment metabolomics screening may be a guide to the prediction of response and a potential approach to the individualization of ketamine therapy .


Many questions remain unanswered about the role of bariatric surgery for people with type 2 diabetes mellitus ( T2DM ) .


To determine feasibility of a randomized clinical trial ( RCT ) and compare initial outcomes of bariatric surgery and a structured weight loss program for treating T2DM in participants with grades I and II obesity .


A 12-month , 3-arm RCT at a single center including 69 participants aged 25 to 55 years with a body mass index ( calculated as weight in kilograms divided by height in meters squared ) of 30 to 40 and T2DM .


Roux-en-Y gastric bypass ( RYGB ) , laparoscopic adjustable gastric banding ( LAGB ) , and an intensive lifestyle weight loss intervention ( LWLI ) .


Primary outcomes in the intention-to-treat cohort were feasibility and effectiveness measured by weight loss and improvements in glycemic control .


Of 667 potential participants who underwent screening , 69 ( 10.3 % ) were randomized .


Among the randomized participants , 30 ( 43 % ) had grade I obesity , and 56 ( 81 % ) were women .


Mean ( SD ) age was 47.3 ( 6.4 ) years and hemoglobin A1c level , 7.9 % ( 2.0 % ) .


After randomization , 7 participants ( 10 % ) refused to undergo their allocated intervention ( 3 RYGB , 1 LAGB , and 3 LWLI ) , and 1 RYGB participant was excluded for current smoking .


Twenty participants underwent RYGB ; 21 , LAGB ; and 20 , LWLI , with 12-month retention rates of 90 % , 86 % , and 70 % , respectively .


In the intention-to-treat cohort with multiple imputation for missing data , RYGB participants had the greatest mean weight loss from baseline ( 27.0 % ; 95 % CI , 30.8-23 .3 ) compared with LAGB ( 17.3 % ; 95 % CI , 21.1-13 .5 ) and LWLI ( 10.2 % ; 95 % CI , 14.8-5 .61 ) ( P < .001 ) .


Partial and complete remission of T2DM were 50 % and 17 % , respectively , in the RYGB group and 27 % and 23 % , respectively , in the LAGB group ( P < .001 and P = .047 between groups for partial and complete remission ) , with no remission in the LWLI group .


Significant reductions in use of antidiabetics occurred in both surgical groups .


No deaths were noted .


The 3 serious adverse events included 1 ulcer treated medically in the RYGB group and 2 rehospitalizations for dehydration in the LAGB group .


This study highlights several potential challenges to successful completion of a larger RCT for treatment of T2DM and obesity in patients with a body mass index of 30 to 40 , including the difficulties associated with recruiting and randomizing patients to surgical vs nonsurgical interventions .


Preliminary results show that RYGB was the most effective treatment , followed by LAGB for weight loss and T2DM outcomes at 1 year .


clinicaltrials.gov Identifier : NCT01047735 .


: Periimplantitis is a bacterial complication after dental implants implantation .


Photodynamic therapy ( PDT ) implies the use of low-power laser in combination with appropriate photosensitizer to increase the detoxification of the implant surfaces .


Little information exists about PDT in the treatment of periimplantitis .


A randomized comparative case-control study has been conducted with 20 patients and 20 controls to compare the efficacy of antimicrobial PDT versus surgical therapy in patients with periimplantitis , who have received dental implants with rough surfaces .


In the surgery group , mucoperiosteal flap surgery was used with scaling on implant surfaces and debridement of granulation tissue .


Microbiologic testing was evaluated before and after intervention treatment , at 12 and 24 weeks in the study subjects .


Total anaerobic counts of bacteria did not differ significantly between patients assigned to receive PDT and those assigned to receive surgical therapy ( mean , 95.2 % and 80.85 % , respectively ) .


PDT was associated with a significant decrease in bleeding scores ( P = 0.02 ) as well as inflammatory exudation ( P = 0.001 ) .


Treatment with PDT in patients with periimplantitis was not associated with major reduction of total anaerobic bacteria on the rough surfaces of dental implants as compared with surgical therapy .


A significantly lower proinflammatory index of periimplantitis was observed in the PDT group at 24 weeks of follow-up .


In multicomponent interventions it is important to examine the implementation of each component to enable valid assessments of the effectiveness of each component .


Many studies do not systematically document , evaluate and report the level of implementation and there is a lack of systematic approaches to conduct process evaluation studies to guide researchers and evaluators .


The aim of this study was to present a systematic approach to plan process evaluation of the implementation of randomised multicomponent interventions .


Building on existing process evaluation frameworks and concepts , we developed a six-step protocol : 1 .


Brainstorm of processes necessary for full implementation and potential barriers and facilitators to implementation ; 2 .


Application of process evaluation concepts to ensure inclusion of important implementation processes ; 3 .


Measurement of proximal outcomes ; 4 .


Identification of relevant data sources ; 5 .


Selection of methods and timing of data collection of process measures ; 6 .


Development of instruments .


The protocol was applied to the Boost study , a multicomponent school-based dietary intervention .


The protocol was readily applicable for planning process evaluation of environmental and educational intervention components in a school setting .


The protocol ensures systematic assessment of the implementation processes that are crucial for interpretation of intervention effects .


Current Controlled Trials ISRCTN11666034 .


To compare the outcomes of multifocal toric intraocular lens ( IOL ) implantation and standard nontoric multifocal IOL implantation combined with peripheral corneal relaxing incisions ( PCRIs ) in patients with moderate preexisting corneal astigmatism .


Moorfields Eye Hospital NHS Foundation Trust , London , United Kingdom .


Prospective randomized controlled trial .


Patients with visually significant cataract in both eyes who desired spectacle independence and had corneal astigmatism ( 1.00 to 2.50 diopters [ D ] ) had multifocal toric IOL implantation in 1 eye and a nontoric multifocal IOL combined with PCRIs ( Donnenfeld nomogram ) in the contralateral eye .


Outcome measures were visual acuity , astigmatic vector reduction , digital toric IOL axis determination , spectacle need , and patient satisfaction .


Thirty patients were enrolled .


Three months postoperatively , the mean residual refractive astigmatism was 0.45 D 0.49 ( SD ) in the toric IOL group and 0.72 0.61 D in the PCRI group .


The mean uncorrected distance visual acuity was 0.10 0.14 in the toric IOL group and 0.15 0.14 in the PCRI group and the mean uncorrected near visual acuity , 0.43 0.11 and 0.39 0.10 , respectively .


The mean absolute misalignment from the intended axis was 2.52 1.97 degrees .


The rotation was within 3 degrees in 90.9 % of all cases and within 6 degrees in all cases .


On the questionnaire , 52.9 % of all patients said they required spectacles only when reading for a long time .


Although refractive astigmatism decreased in both groups , multifocal toric IOL implantation was predictable with good rotational stability .


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


The purpose of this study was to examine the methodological integrity , sample size requirements , and short-term preliminary clinical outcomes of manual and manipulative therapy ( MMT ) in addition to a rehabilitation program for symptomatic knee osteoarthritis ( OA ) .


This was a pilot study of an assessor-blinded , randomized , parallel-group trial in 2 independent university-based outpatient clinics .


Participants with knee OA were randomized to 3 groups : 6 MMT sessions alone , training in rehabilitation followed by a home rehabilitation program alone , or MMT plus the same rehabilitation program , respectively .


Six MMT treatment sessions ( provided by a chiropractic intern under supervision or by an experienced chiropractor ) were provided to participants over the 4-week treatment period .


The primary outcome was a description of the research methodology and sample size estimation for a confirmatory study .


The secondary outcome was the short-term preliminary clinical outcomes .


Data were collected at baseline and 5weeks using the Western Ontario and McMasters Osteoarthritis Index questionnaire , goniometry for knee flexion/extension , and the McMaster Overall Therapy Effectiveness inventory .


Analysis of variance was used to compare differences between groups .


Eighty-three patients were randomly allocated to 1 of the 3 groups ( 27 , 28 , and 28 , respectively ) .


Despite 5 dropouts , the data from 78 participants were available for analysis with 10 % of scores missing .


A minimum of 462 patients is required for a confirmatory 3-arm trial including the respective interventions , accounting for cluster effects and a 20 % dropout rate .


Statistically significant and clinically meaningful changes in scores from baseline to week 5 were found for all groups for the Western Ontario and McMasters Osteoarthritis Index ( P .008 ) , with a greater change in scores for MMT and MMT plus rehabilitation .


Between-group comparison did not reveal statistically significant differences between group scores at week 5 for any of the outcome measures ( P .46 ) .


This pilot trial suggests that a confirmatory trial is feasible .


There were significant changes in scores from baseline to week 5 across all groups , suggesting that all 3 treatment approaches may be of benefit to patients with mild-to-moderate knee OA , justifying a confirmatory trial to compare these interventions .


To assess , in a school-located adolescent vaccination program that billed health insurance , the program costs , the proportion of costs reimbursed , and the likelihood of vaccination .


During the 2010-2011 school year , vaccination clinics were held for sixth - to eighth-grade students at seven Denver public schools .


Vaccine administration and purchase costs were compared with reimbursement by insurers .


Multivariate analyses were used to compare the likelihood of vaccination among students in intervention schools with students in control schools who did not participate in the program , with analyses stratified by grade ( sixth grade vs. seventh-eighth grades ) .


Fifteen percent ( 466 of 3,144 ) of students attending intervention schools were vaccinated at school-located vaccination clinics .


Among students vaccinated at school , 41 % were uninsured , 37 % publicly insured , and 22 % privately insured .


Estimated vaccine administration costs were $ 23.98 per vaccine dose .


Seventy-eight percent of vaccine purchase costs and 14 % of vaccine administration costs were reimbursed by insurers ; 41 % of total program costs were reimbursed .


Sixth-grade students in intervention schools were more likely than those in control schools to receive tetanus-diphtheria-acellular pertussis ( risk ratio [ RR ] , 1.30 ; 95 % confidence interval [ CI ] , 1.08 , 1.57 ) , meningococcal conjugate ( RR , 1.42 ; CI , 1.18 , 1.70 ) , and human papillomavirus ( for females only , RR , 1.69 ; CI , 1.21 , 2.36 ) vaccines during the 2010-2011 school year , with similar results for seventh - to eighth-grade students .


Although school-located adolescent vaccination with billing appears feasible and likely to improve vaccination rates , improvements in insurance coverage and reimbursement rates may be needed for the long-term financial sustainability of such programs .


To examine protocol adherence to structured intensive management in the Valsartan Intensified Primary carE Reduction of Blood Pressure ( VIPER-BP ) study involving 119 primary care clinics and 1562 randomized participants .


Prospective criteria for assessing adherence to treatment prescription , uptitration , and visit attendance at 6 , 10 , 14 , and 18 weeks postrandomization were applied to 1038 intervention participants .


Protocol adherence scores of 1-5 ( least to most adherent ) were compared to blood pressure ( BP ) control during 26 weeks of follow-up .


Mean age was 59.312.0 years , 963 ( 62 % ) were men , and 1045 ( 67 % ) had longstanding hypertension .


Clinic attendance dropped from 91 ( week 6 ) to 83 % ( week 26 ) and pharmacological instructions were followed for 93 % ( baseline ) to 61 % at week 14 ( uptitration failures commonly representing protocol deviations ) .


Overall , 26-week BP levels and BP target attainment ranged from 13214/799 and 51 % to 14115/8311 mmHg and 19 % in those participants subject to the highest ( n = 270 , 26 % ) versus least ( n = 148 , 14 % ) per protocol adherence , respectively ; adjusted relative risk ( RR ) 1.22 per unit protocol adherence score , 95 % confidence interval ( CI ) 1.15-1 .31 ; for achieving BP target ( P < 0.001 ) .


Participants with a per protocol score of 4 or 5 ( 512/1038 , 49.3 % ) were 1.54-fold ( 95 % CI 1.31-1 .81 ; P < 0.001 ) more likely to achieve their individual BP target compared with usual care .


Clinics equipped with a practice nurse significantly influenced protocol adherence ( adjusted RR 1.20 , 95 % CI 1.06-1 .37 ; P = 0.004 ) and individual BP control ( RR 1.21 , 95 % CI 1.04-1 .41 ; P = 0.015 ) .


There is considerable potential for structured care management to improve BP control in primary care , especially when optimally applied .


Rheumatoid arthritis ( RA ) is associated with heightened mortality due to atherosclerotic cardiovascular disease ( CVD ) .


Inflammatory pathways in RA negatively affect vascular physiology and promote metabolic disturbances that contribute to CVD .


We hypothesized that the peroxisome proliferator activated receptor - ( PPAR - ) pioglitazone could promote potent vasculoprotective and anti-inflammatory effects in RA .


One hundred forty-three non-diabetic adult RA patients ( 76.2 % female , age 55.2 12.1 [ mean SD ] ) on stable RA standard of care treatment were enrolled in a randomized , double-blind placebo controlled crossover trial of 45 mg daily pioglitazone versus placebo , with a 3-month duration/arm and a 2-month washout period .


Pulse wave velocity of the aorta ( PWV ) , brachial artery flow mediated dilatation ( FMD ) , nitroglycerin mediated dilatation ( NMD ) , microvascular endothelial function ( reactive hyperemia index [ RHI ] ) , and circulating biomarkers of inflammation , insulin resistance , and atherosclerosis risk all were quantified .


RA disease activity was assessed with the 28-Joint Count Disease Activity Score ( DAS-28 ) C-reactive protein ( CRP ) and the Short Form ( 36 ) Health Survey quality of life questionnaire .


When added to standard of care RA treatment , pioglitazone significantly decreased pulse wave velocity ( ie , aortic stiffness ) ( P = 0.01 ) , while FMD and RHI remained unchanged when compared to treatment with placebo .


Further , pioglitazone significantly reduced RA disease activity ( P = 0.02 ) and CRP levels ( P = 0.001 ) , while improving lipid profiles .


The drug was well tolerated .


Addition of pioglitazone to RA standard of care significantly improves aortic elasticity and decreases inflammation and disease activity with minimal safety issues .


The clinical implications of these findings remain to be established .


ClinicalTrials.gov Unique Identifier : NCT00554853 .


The relation between inflammatory markers , adiposity and disease is under extensive study .


Here we tested the hypothesis that the immunomodulatory protein pentraxin 3 ( PTX3 ) is associated with adiposity in the general population .


Serum PTX3 concentrations , body mass index ( BMI ) , waist circumference ( WC ) and fat depots , as quantified by dual-energy X-ray absorptiometry and magnetic resonance imaging , were assessed in three community-based cohorts : ULSAM , n = 790 , mean age 78 years ; PIVUS , n = 1003 , mean age 70 years , women 50 % ; and the NORDIET-trial , n = 86 , mean age 53 years , women 63 % .


Participants were re-examined after 5 years ( PIVUS , n = 804 ) or following a 6-week randomized controlled dietary intervention ( NORDIET ) .


PTX3 levels were inversely associated with BMI and WC as well as with total and visceral fat ( P < 0.05 for all ; adjusted for age , inflammatory biomarkers and cardiovascular risk factors ) .


The association between PTX3 and BMI appeared even stronger in nonobese individuals .


A decrease in BMI over 5 years as well as weight loss following the NORDIET intervention were associated with increased serum PTX3 concentrations ( P < 0.001 ) .


These consistent data support an inverse association between circulating PTX3 and anthropometrical measures , calling for further mechanistic studies of the link between PTX3 and fat .


Low colo-rectal anastomoses have a relevant risk of leakage .


The protective stomas ( ileostomy or colostomy ) have always been utilized to reduce the complications due to anastomotic leakage .


The stoma not only causes relevant morbidity but also needs a second operation to be closed , with an added risk of complications .


For this reason we planed and carried out a temporary percutaneous ileostomy by a jejunal probe introduced in the distal ileum , that can be removed without a surgical procedure and with negligible complications .


The ALPPI trial is a randomized controlled , open , parallel , equivalence multicenter study .


Patients undergoing elective laparoscopic or laparotomic surgery for rectal cancer with extraperitoneal anastomosis , will be randomly allocated to undergo either lateral ileostomy or percutaneous ileostomy by exclusion probe .


The primary endpoint is the protection of the extraperitoneal colo-rectal anastomosis in terms of incidence of symptomatic and asymptomatic anastomotic leakages .


The secondary endpoints are the evaluation of complications due to the placement and the removal of the exclusion probe for percutaneous ileostomy .


The ALPPI trial is designed to provide the surgical community with an evidence based new technique in the protection of low colo-rectal anastomosis , alternative to the conventional stomas .


The ALPPI trial was approved by the Ethical Committee of Regional Public Health System of Umbria , Italy , ( Protocol Number 28657/11/AV , study code RO-MA 01 ) and it is registered in the International Standard Randomised Controlled Trial Number ( ISRCTN ) Register with identification number ISRCTN99356919 .


To evaluate the short-term efficacy of agents containing KNO3 or casein phosphopeptide - amorphous calcium phosphate ( CPP-ACP ) in the treatment of dentin hypersensitivity .


UltraEZ , containing KNO3 and MI Paste , containing CPP-ACP were applied in this study .


The dentin hypersensitivity of 102 subjects was established by a tactile stimulus with a Yeaple preasure probe , and the degree of hypersensitivity was measured using a visual analogue scale ( VAS ) .


The patients were divided into four groups : A , B , C and D , using a random number table .


UltraEZ , a placebo of UltraEZ , MI Paste , and a placebo of MI Paste were applied to group A , B , C and D respectively for 2 weeks .


Dentin hypersensitivity was measured using VAS before the treatment ( baseline ) , on day 2 , 7 , and 14 during the treatment , and on day 30 and 60 posttreatment .


The efficacy of UltraEZ on dentin hypersensitivity was significantly better than that of the corresponding placebo group on day 7 during the treatment , whereas the efficacy of MI Paste exhibited better than that of the placebo group on day 14 during the treatment .


However , there were no differences between the efficacy of the two agents on day 14 during the treatment , day 30 or day 60 posttreatment .


Both UltraEZ and MI Paste had a significant effect on dentin hypersensitivity .


UltraEZ showed quicker effects than MI Paste , but MI Paste had a greater sustained action after treatment than UltraEZ .


This prospective randomized study compared acute and chronic anterior cruciate ligament ( ACL ) reconstruction using ligament advanced reinforcement system ( LARS ) artificial ligament in young active adults with a 5-year follow-up .


Fifty-five patients were enrolled in this study and divided into two groups based on the elapsed time between the injury and reconstruction : the acute group ( 3-7 weeks ) and the chronic group ( 6-11 months ) .


The clinical outcomes were evaluated using the Lysholm knee scoring scale , the Tegner activity rating , a KT-1000 Arthrometer , and the International Knee Documentation Committee ( IKDC ) scoring system .


Isokinetic strength of the quadriceps and hamstring was assessed using the Biodex System 3 isokinetic dynamometer .


Anterior laxity was decreased and quadriceps/hamstring muscle strength was increased in the acute group compared to the chronic group ( p > 0.05 ) .


There were no statistically significant differences in Lysholm scores , Tegner activity scores , and the IKDC evaluation form between the two groups .


These results suggest that earlier ACL reconstruction using a LARS artificial ligament may provide an advantage in the treatment and rehabilitation of ACL rupture .


The protein leverage hypothesis requires specific evidence that protein intake is regulated more strongly than energy intake .


The objective was to determine ad libitum energy intake , body weight changes , appetite profile , and nitrogen balance in response to 3 diets with different protein-to-carbohydrate + fat ratios over 12 consecutive days , with beef as a source of protein .


A 3-arm , 12-d randomized crossover study was performed in 30 men and 28 women [ mean SD age : 33 16 y ; body mass index ( in kg/m ) : 24.4 4.0 ] with the use of diets containing 5 % , 15 % , and 30 % of energy ( En % ) from protein , predominantly from beef .


Energy intake was significantly lower in the 30En % - protein condition ( 8.73 1.93 MJ/d ) than in the 5En % - protein ( 9.48 1.67 MJ/d ) and 15En % - protein ( 9.30 1.62 MJ/d ) conditions ( P = 0.001 ) , stemming largely from lower energy intake during meals ( P = 0.001 ) .


Hunger ( P = 0.001 ) and desire to eat ( P = 0.001 ) ratings were higher and fullness ratings were lower ( P = 0.001 ) in the 5En % - protein condition than in the 15En % - protein and 30En % - protein conditions .


Nitrogen excretion was lower in the 5En % - protein condition ( 4.7 1.5 g/24 h ; P = 0.001 ) and was higher in the 30En % - protein condition ( 15.3 8.7 g/24 h ; P = 0.001 ) compared with the 15En % - protein condition ( 10.0 5.2 g/24 h ) .


Nitrogen balance was maintained in the 5En % - protein condition and was positive in the 15En % - and 30En % - protein conditions ( P = 0.001 ) .


Complete protein leverage did not occur because subjects did not consume to a common protein amount at the expense of energy balance .


Individuals did underconsume relative to energy requirements from high-protein diets .


The lack of support for protein leverage effects on a low-protein diet may stem from the fact that protein intake was sufficient to maintain nitrogen balance over the 12-d trial .


To compare hyperfractionation versus standard fractionation for T2N0 vocal cord carcinoma in a randomized controlled trial .


Patients with T2 vocal cord cancer were stratified by substage ( T2a vs T2b ) and randomly assigned to receive either hyperfractionation ( HFX ) to 79.2 Gy in 66 fractions of 1.2 Gy given twice a day , or standard fractionation ( SFX ) to 70 Gy in 35 fractions given once a day .


The trial was designed to detect a 55 % reduction in the local failure hazard rate with 80 % statistical power .


Between April 1996 and July 2003 , a total of 250 patients were enrolled .


Of 239 patients analyzable for outcomes , 94 % were male , 83 % had a Karnofsky performance status of 90-100 , and 62 % had T2a tumor .


Median follow-up for all surviving patients was 7.9 years ( range , 0.6-13 .1 years ) .


The 5-year local control ( LC ) rate was 8 points higher but not statistically significant ( P = .14 for HFX [ 78 % ] vs SFX [ 70 % ] ) , corresponding to a 30 % hazard rate reduction .


The 5-year disease-free survival ( DFS ) was 49 % versus 40 % ( P = .13 ) and overall survival ( OS ) was 72 % versus 63 % ( P = .29 ) .


HFX was associated with higher rates of acute skin , mucosal , and laryngeal toxicity .


Grade 3-4 late effects were similar with a 5-year cumulative incidence of 8.5 % ( 3.4 % -13.6 % ) after SFX and 8.5 % ( 3.4 % -13.5 % ) after HFX .


The 5-year local control was modestly higher with HFX compared to SFX for T2 glottic carcinoma , but the difference was not statistically significant .


These results are consistent with prior studies of hyperfractionation showing a benefit in local control .


Substaging by T2a versus T2b carries prognostic value for DFS and OS .


For cost and convenience reasons other altered fractionation schedules have been adopted in routine practice .


Surgery followed by radiotherapy and concomitant and adjuvant temozolomide is standard therapy in newly diagnosed glioblastoma multiforme ( GBM ) .


Bevacizumab combined with irinotecan produces impressive response rates in recurrent GBM .


In a randomized phase II study , we investigated the efficacy of neoadjuvant bevacizumab combined with irinotecan ( Bev-Iri ) versus bevacizumab combined with temozolomide ( Bev-Tem ) before , during and after radiotherapy in newly diagnosed GBM .


After surgery , patients were randomized to Bev-Iri or Bev-Tem for eight weeks , followed by standard radiotherapy ( 60 Gy/30 fractions ) and concomitant Bev-Iri or Bev-Tem followed by adjuvant Bev-Iri or Bev-Tem for another eight weeks .


Bev-Iri : Bevacizumab and irinotecan were given every 14 days before , during and after radiotherapy .


Bev-Tem : Bevacizumab was given as in Bev-Iri and temozolomide was given for five days every four weeks before and after radiotherapy and once daily during radiotherapy .


The primary endpoint was response after neoadjuvant chemotherapy and a pre-specified response rate of 30 % or more was considered of interest for future studies .


Secondary endpoints were progression-free survival ( PFS ) and toxicity .


The response rate was 32 % ( 95 % CI 17-51 % ) for Bev-Tem ( n = 32 ) and 23 % ( 95 % CI 9-44 % ) for Bev-Iri ( n = 31 ) ( p = 0.56 ) .


Median PFS was 7.7 and 7.3 months for Bev-Tem and Bev-Iri , respectively .


Hematological toxicity was more frequent with Bev-Tem including one death from febrile neutropenia whereas non-hematological toxicity was manageable .


Only the Bev-Tem arm met the pre-specified level of activity of interest .


Our results did not indicate any benefit from Bev-Iri in first-line therapy as opposed to Bev-Tem in terms of response and PFS .


Lifetime prevalence of amphetamine-induced psychotic disorder is reported as being up to 23 % for methamphetamine ( MA ) abusers .


Approximately 25 % of those with a baseline DSM-IV diagnosis of substance-induced psychosis are diagnosed with primary psychosis at one-year follow-up .


Evidence on the treatment of amphetamine psychosis is very limited .


To investigate the efficacy of risperidone versus aripiprazole in treatment of amphetamine-induced psychotic symptoms .


In a double-blind study , 45 participants were randomly allocated to either aripiprazole 15mg or risperidone 4mg daily over a six-week trial .


Positive and negative symptoms of psychosis were assessed using the Scale for Assessment of Negative Symptoms ( SANS ) and the Scale for Assessment of Positive Symptoms ( SAPS ) at baseline and completion of the trial .


SANS and SAPS scores decreased significantly in both groups .


Mean SAPS score reduction in risperidone and aripiprazole group was 16.20 and 10.80 , respectively , after trial course ( p < 0.001 ) .


Mean SANS score reduction in risperidone and aripiprazole group was 9.35 and 11.25 , respectively ( p = 0.08 ) .


Both aripiprazole and risperidone were effective for patients diagnosed with amphetamine-induced psychotic disorder .


However , risperidone had the greater effect on positive psychotic symptoms while patients with negative symptoms may respond better to aripiprazole .


There is a case for further studies evaluating the efficacy of atypical antipsychotics in this disorder .


Concomitant administration of erlotinib with standard chemotherapy does not appear to improve survival among patients with non-small-cell lung cancer ( NSCLC ) , but preliminary studies suggest that sequential administration might be effective .


To assess the efficacy and tolerability of second-line sequential administration of erlotinib and docetaxel in advanced NSCLC .


In an open-label phase II trial , patients with advanced NSCLC , EGFR wild-type or unknown , PS 0-2 , in whom initial cisplatin-based chemotherapy had failed were randomized to sequential erlotinib 150 mg/d ( day 2-16 ) + docetaxel ( 75 mg/m ( 2 ) d1 ) ( arm ED ) or docetaxel ( 75 mg/m ( 2 ) d1 ) alone ( arm D ) ( 21-day cycle ) .


The primary endpoint was the progression-free survival rate at 15 weeks ( PFS 15 ) .


Secondary endpoints included PFS , overall survival ( OS ) , the overall response rate ( ORR ) and tolerability .


Based on a Simon optimal two-stage design , the ED strategy was rejected if the primary endpoint was below 33/66 patients at the end of the two Simon stages .


147 patients were randomized ( median age : 608 years , PS 0/1/2 : 44/83/20 patients ; males : 78 % ) .


The ED strategy was rejected , with only 18 of 73 patients achieving PFS15 in arm ED at the end of stage 2 and 17 of 74 patients in arm D.


In arms ED and D , respectively , median PFS was 2.2 and 2.5 months and median OS was 6.5 and 8.3 months .


Sequential erlotinib and docetaxel was not more effective than docetaxel alone as second-line treatment for advanced NSCLC with wild-type or unknown EGFR status .


The immunogenicity , reactogenicity and safety of the 10 - valent pneumococcal non-typeable Haemophilus influenzae protein D conjugate vaccine ( PHiD-CV ) were evaluated in a cohort of Nigerian infants included in a study conducted in Mali and Nigeria ( ClinicalTrials.gov identifier : NCT00678301 ) .


In this open , randomised , controlled study , 119 healthy infants received combined diphtheria-tetanus-whole-cell pertussis-hepatitis B / Haemophilus influenzae type b vaccine ( DTPw-HBV/Hib ) and oral poliovirus vaccine ( OPV ) co-administered with PHiD-CV ( PHiD-CV group ) or without PHiD-CV ( control group ) at 6-10-14 weeks of age .


Pneumococcal antibody responses and opsonophagocytic activity were measured and adverse events were recorded .


One month post-dose 3 , for each of the vaccine pneumococcal serotypes , e `` 90.1 % of PHiD-CV recipients had an antibody concentration e `` 0.2 ug/mL compared to < 9 % ( except for serotypes 14 [ 32.4 % ] and 19F [ 27.8 % ] ) in the control group .


For each of the vaccine pneumococcal serotypes , e `` 90.6 % of infants in the PHiD-CV group had an OPA titre e `` 8 , compared to % 18 % ( except for serotype 7F [ 60.0 % ] ) in the control group .


Anti-protein D antibody geometric mean antibody concentrations were 2949.7 EL.U / mL in the PHiD-CV group and 68.9 EL.U / mL in the control group .


For each DTPw-HBV/Hib antigen antibody seroprotection/seropositivity rates were e `` 94.4 % .


Tolerability was generally comparable between the PHiD-CV and control vaccination groups .


PHiD-CV co-administered with routine vaccines was immunogenic for all vaccine pneumococcal serotypes and protein D in Nigerian infants .


Vaccine tolerability was generally comparable between the PHiD-CV and control groups .


These results suggest PHiD-CV can be co-administered with other vaccines included in the National Programme on Immunisation .


Post-thrombotic syndrome ( PTS ) is a serious complication of deep vein thrombosis ( DVT ) of the leg that affects 20-50 % of patients .


Once a patient experiences PTS there is no treatment that effectively reduces the debilitating complaints .


Two randomised controlled trials showed that elastic compression stocking ( ECS ) therapy after DVT for 24 months can reduce the incidence of PTS by 50 % .


However , it is unclear whether all patients benefit to the same extent from ECS therapy or what the optimal duration of therapy for individual patients should be .


ECS therapy is costly , inconvenient , demanding and sometimes even debilitating .


Tailoring therapy to individual needs could save substantial costs .


The objective of the IDEAL DVT study , therefore , is to evaluate whether tailoring the duration of ECS therapy on signs and symptoms of the individual patient is a safe and effective method to prevent PTS , compared with standard ECS therapy .


A multicentre , single-blinded , allocation concealed , randomised , non-inferiority trial .


A total of 864 consecutive patients with acute objectively documented proximal DVT of the leg are randomised to either standard duration of 24 months or tailored duration of ECS therapy following an initial therapeutic period of 6 months .


Signs and symptoms of PTS are recorded at regular clinic visits .


Furthermore , quality of life , costs , patient preferences and compliance are measured .


The primary outcome is the proportion of patients with PTS at 24 months .


Based on current knowledge the standard application of ECS therapy is questioned .


The IDEAL DVT study will address the central questions that remain unanswered : Which individual patients benefit from ECS therapy and what is the optimal individual treatment duration ?


Primary ethics approval was received from the Maastricht University Medical Centre .


Results of the study will be disseminated via peer-reviewed publications and presentations at scientific conferences .


NCT01429714 and NTR 2597 .


To evaluate the effect of newly designed positively aspherized progressive addition lenses ( PA-PALs ) , which reduce both lag of accommodation and hyperopic defocus on the peripheral retina , on the progression of early-onset myopia .


Positively aspherized-PALs have near addition and high positive distance zone aspherization comparable to the addition power .


One hundred ninety-seven children were enrolled , 6 to 12 years of age , with spherical equivalent refraction from -1.00 to -4.50 diopters ( D ) .


The children were randomized to receive one of three lenses : single vision lenses ( SVLs ) , PA-PALs with +1.0 D addition , or PA-PALs with +1.5 D addition .


Follow-up visits occurred every 6 months for 2 years .


The primary outcome was myopia progression evaluated by cycloplegic autorefraction .


One hundred sixty-nine ( 86 % ) children completed the follow-up .


Statistical analysis of adjusted progression rates showed a mean ( SE ) progression of -1.39 0.09 D in the control group wearing SVLs at the 24-month visit .


Statistically significant ( P = 0.017 ) retardation of myopia progression ( 0.27 0.11 D during 24-month period or reduction ratio of 20 % ) by +1.5 D add PA-PALs relative to the SVLs was found , which was within the range of the percentage efficacy of myopia retardation by the conventional PALs in earlier trials over the same follow-up period .


Nearly all retardation occurred in the first 12 months with no significant efficacy in the second year .


Positively aspherized-PALs with +1.0 D addition showed negligible efficacy .


To the extent that has been tested and that can be tolerated by wearers of spectacle lenses , the high positive aspherization of the distance zone added to PALs does not enhance their therapeutic efficacy in slowing myopia progression .


( http://www.anzctr.org.au/ number , ACTRN12608000566336 ) .


To study the clinical effects of hypoxia preconditioning ( HPC ) and its effects on serum neuroglobin ( NGB ) and S-100B level in the patients undergoing intracranial aneurysm surgery .


Forty patients scheduled to intracranial aneurysm surgery were randomly.divided into 2 groups : HPC group ( n = 20 ) and control group ( n = 20 ) .


The patients in HPC group were treated with 3 cycles of deoxidation-reoxygenation after intubation .


The time of deoxidation in each HPC cycle was recorded , while vital signs were also recorded in each corresponding time point .


Blood samples were obtained from exsanguinate radial artery and jugular bulb section at the end of each HPC cycle and corresponding time points during operation to measure serum level of NGB and S100B protein and to analysis blood gas .


During HPC process , the patients in group HPC experienced mild hypoxia and CO2 retention .


With the times of HPC increasing , CO2 retention degree became heavier ( P < 0.05 ) while hypoxia improved , the patients need more time to make SpO2 from 100 % to 90 % ( P < 0.05 ) .


From T2 to T4 ( the end of the third reoxygenation , during skull opened and aneurysm dipped , skull closed ) , NGB in group HPC was higher than that in control ( P < 0.05 ) , but S-100B level was not different between HPC and control group ( P > 0.05 ) .


HPC could induce compensatory ability of the body to hypoxia , which might be related to the up-regulation of NGB expression .


The purpose of this study was to assess pulmonary lesion detection , diagnostic confidence , and noise reduction in sparse-sampled ( SpS ) computed tomographic ( CT ) data of submillisievert ( SubmSv ) chest CT reconstructed with iterative reconstruction technique ( IRT ) .


This Human Insurance Portability and Accountability-compliant , institutional review board-approved prospective study was performed using SpS-SubmSv IRT chest CT in 10 non-obese patients ( body-mass index , 21-35 kg/m ; age range , 26-90 years ) .


Written informed consent was obtained .


The patients were scanned at standard-dose CT ( mean [ SD ] volumetric CT dose index , 6 [ 0.9 ] mGy ; mean [ SD ] dose-length product , 208 44 mGycm ; and mean [ SD ] effective dose , 3 [ 0.6 ] mSv ) and at SubmSv dose ( 1.8 [ 0.2 ] mGy , 67 [ 2 ] mGycm , 0.9 [ 0.03 ] mSv , respectively ) on a Philips 128-slice CT scanner with double z-sampling .


Sparse angular sampling data were reconstructed using 25 % of the angular projections from the SubmSv sinogram to reduce the number of views and radiation dose by approximately 4-fold .


Hence , the patients were scanned and then , simulation-based sparse sampling was performed with a resultant dose hypothetical SpS scan estimated mathematically ( 0.2 mSv ) .


From each patient data , 3 digital imaging and communications in medicine series were generated : SpS-SubmSv with IRT , fully sampled SubmSv filtered back projection ( FBP ) , and fully sampled standard-dose FBP ( SD-FBP ) .


Two radiologists independently assessed these image series for detection of lung lesions , visibility of small structures , and diagnostic acceptability .


Objective noise was measured in the thoracic aorta , and noise spectral density was obtained for SpS-SubmSv IRT , SubmSv-FBP , and SD-FBP .


The SpS-SubmSv IRT resulted in 75 % ( 0.2 / 0.9 mSv ) and 92 % ( 0.2 / 2.9 mSv ) dose reduction , when compared with the fully sampled SubmSv-FBP and SD-FBP , respectively .


Images of SpS-SubmSv displayed all 46 lesions ( most < 1 cm , 30 lung nodules , 7 ground glass opacities , 9 emphysema ) seen on the SubmSv-FBP and SD-FBP data sets .


Lesion margins with sparse-sampled data were deemed acceptable compared with both SubmSv-FBP and SD-FBP .


Overall diagnostic confidence was maintained with SpS-SubmSv IRT despite the presence of minor pixilation artifacts in 3 of 10 cases .


The SpS-SubmSv IRT showed 63 % and 38 % noise reduction when compared with SubmSv-FBP ( P < 0.0001 ) and SD-FBP ( P < 0.01 ) , respectively , with no significant change in Hounsfield unit values ( P > 0.05 ) .


Noise-spectral density showed that SpS-SubmSv IRT gives a linear decrease over frequency in the semilog plot and an exponential decrease of noise power over frequency compared with SubmSv-FBP and SD-FBP .


More than 90 % dose reduction could be achieved with one-fourth sparse-sampled and SubmSv chest CT examination when reconstructed with IRT .


Chest CT dose at one fourth of a millisievert with SpS is possible with optimal lesion detection and diagnostic confidence for the evaluation of pulmonary findings .


A number of interventions for at-risk children have shown benefits for children 's hypothalamic-pituitary-adrenal axis activity immediately after treatment .


It is critical to examine whether such changes are maintained over time , given that physiological regulation is implicated in later mental and physical health outcomes .


To examine whether differences in diurnal cortisol production between children receiving the active parenting intervention and children in the control group persisted at a preschool follow-up ( approximately 3 years following intervention ) .


Between-subject comparison of cortisol patterns among 2 groups of children ( experimental and control groups ) involved with Child Protective Services following allegations of neglect .


The participants included 115 children ( 43.5 % female ) between 46.5 and 69.6 months of age ( mean [ SD ] , 50.73 [ 4.98 ] months ) who had been previously randomly assigned to either the Attachment and Biobehavioral Catch-up ( ABC ) intervention ( n = 54 ) or the control intervention ( n = 61 ) .


The experimental ABC intervention focused on 3 aims : increasing parental nurturance to child distress , increasing synchronous interactions , and decreasing frightening parental behavior .


The control intervention provided educational information about child development to parents .


Both interventions were manualized and involved 10 sessions implemented by a trained parent coach in the families ' homes or other places of residence .


Salivary cortisol samples collected at waking and bedtime for children on 3 separate days .


Analyses revealed significant differences in cortisol production at the preschool follow-up , such that children in the ABC intervention group showed more typical patterns of cortisol production than children in the control intervention group .


Specifically , children in the ABC group exhibited higher mean ( SD ) log-transformed morning levels than children in the control group ( -0.87 [ 0.45 ] vs -1.05 [ 0.43 ] g/dL , respectively [ to convert to nanomoles per liter , multiply by 27.588 ] ; = 0.18 ; P = .03 ) .


Bedtime cortisol levels did not differ significantly between the ABC and DEF groups ( mean [ SD ] , -1.19 [ 0.49 ] vs -1.17 [ 0.48 ] g/dL , respectively ; 01 = -0.01 ; P = .87 ) .