Fifty-five participants received trastuzumab administered concurrently with anthracycline-containing adjuvant regimen and 54 patients received trastuzumab administered sequentially with anthracycline .


The primary cardiac event was asymptomatic decrease in the left ventricular ejection fraction ( LVEF ) .


There was no significant difference between concurrent and sequential groups in cardiac event rates ( 9.1 % vs13 .0 % , P = 0.556 ) , neither of LVEF values at basline or at 3 , 6 , 9 and 12 months during trastuzumab treatment ( P > 0.05 ) .


Four patients ( 7.3 % ) in the concurrent group suffered local recurrences or distant metastases , and 6 participants ( 11.1 % ) in the sequential group had distant metastases .


There was no significant difference between the two groups in DFS ( P = 0.724 ) .


There was no death in both groups .


Trastuzumab administered concurrently with anthracycline is a safe adjuvant regimen for breast cancer and does not increase cardiac events .


Further research is needed to determine the efficacy of this treatment regimen .


Anthroponotic cutaneous leishmaniasis ( CL ) due to Leishmania ( L. ) tropica infection is a chronic , frequently disfiguring skin disease with limited therapeutic options .


In endemic countries healing of ulcerative lesions is often delayed by bacterial and/or fungal infections .


Here , we studied a novel therapeutic concept to prevent superinfections , accelerate wound closure , and improve the cosmetic outcome of ACL .


From 2004 to 2008 we performed a two-armed , randomized , double-blinded , phase IIa trial in Kabul , Afghanistan , with patients suffering from L. tropica CL .


The skin lesions were treated with bipolar high-frequency electrocauterization ( EC ) followed by daily moist-wound-treatment ( MWT ) with polyacrylate hydrogel with ( group I ) or without ( group II ) pharmaceutical sodium chlorite ( DAC N-055 ) .


Patients below age 5 , with facial lesions , pregnancy , or serious comorbidities were excluded .


The primary , photodocumented outcome was the time needed for complete lesion epithelialization .


Biopsies for parasitological and ( immuno ) histopathological analyses were taken prior to EC ( 1 ( st ) ) , after wound closure ( 2 ( nd ) ) and after 6 months ( 3 ( rd ) ) .


The mean duration for complete wound closure was short and indifferent in group I ( 59 patients , 43.1 d ) and II ( 54 patients , 42 d ; p = 0.83 ) .


In patients with Leishmania-positive 2 ( nd ) biopsies DAC N-055 caused a more rapid wound epithelialization ( 37.2 d vs. 58.3 d ; p = 0.08 ) .


Superinfections occurred in both groups at the same rate ( 8.8 % ) .


Except for one patient , reulcerations ( 10.2 % in group I , 18.5 % in group II ; p = 0.158 ) were confined to cases with persistent high parasite loads after healing .


In vitro , DAC N-055 showed a leishmanicidal effect on pro- and amastigotes .


Compared to previous results with intralesional antimony injections , the EC plus MWT protocol led to more rapid wound closure .


The tentatively lower rate of relapses and the acceleration of wound closure in a subgroup of patients with parasite persistence warrant future studies on the activity of DAC N-055 .


ClinicalTrails.gov NCT00947362 .


To evaluate the effects of energy restriction with or without aerobic exercise on thigh muscle mass and quality in adults with visceral adiposity .


75 males and females were randomly assigned to the groups ` diet only ' ( DO ; n = 42 ) or ` diet plus aerobic exercise ' ( D/Ex ; n = 33 ) for 12 weeks .


The target energy intake in both groups was 25 kcal/kg of ideal body weight .


Subjects in the D/Ex group were instructed to exercise for 300 min/week at lactate threshold .


Computed tomography was used to measure thigh muscle cross-sectional area ( CSA ) , normal-density muscle area ( NDMA ) , and visceral fat area .


Total body weight ( DO : -6.6 3.6 % ; D/Ex : -7.3 4.6 % ) and visceral fat ( DO : -16.0 13.8 % ; D/Ex : -23.1 14.7 % ) decreased significantly in both groups ; however , the changes were not significantly different between the two groups .


The decrease in muscle CSA was significantly greater in the DO group ( -5.1 4.5 % ) compared with the D/Ex group ( -2.5 5.0 % ) .


NDMA decreased significantly in the DO ( -4.9 4.9 % ) but not in the D/Ex group ( -1.4 5.0 % ) .


Aerobic exercise attenuated the loss of skeletal muscle during energy restriction in adults with visceral adiposity .


Splanchnic hypoperfusion is a physiological phenomenon during strenuous exercise .


It has been associated with gastrointestinal symptoms and intestinal injury and may hamper athletic performance .


We hypothesized that L-citrulline supplementation improves splanchnic perfusion and decreases intestinal injury by enhancing arginine availability .


The aim of this study was to determine the effect of L-citrulline intake on splanchnic perfusion , intestinal injury , and barrier function during exercise .


In this randomized , double-blind crossover study , 10 men cycled for 60 min at 70 % of their maximum workload after L-citrulline ( 10 g ) or placebo ( L-alanine ) intake .


Splanchnic perfusion was assessed using gastric air tonometry .


Sublingual microcirculation was evaluated by sidestream dark field imaging .


Plasma amino acid levels and intestinal fatty acid binding protein concentrations , reflecting enterocyte damage , were assessed every 10 min .


Urinary excretion of sugar probes was measured to evaluate intestinal permeability changes .


Oral L-citrulline supplementation enhanced plasma citrulline ( 1840.3 142.3 M ) and arginine levels ( 238.5 9.1 M ) compared with that in placebo ( 45.7 4.8 M and 101.5 6.1 M , respectively , P < 0.0001 ) , resulting in increased arginine availability .


Splanchnic hypoperfusion was prevented during exercise after L-citrulline ingestion ( reflected by unaltered gapg-apCO2 levels ) , whereas gapg-apCO2 increased with placebo treatment ( P < 0.01 ) .


Accordingly , L-citrulline intake resulted in an increased number of perfused small sublingual vessels compared with that in placebo ( 7.8 6.0 vs -2.0 2.4 , P = 0.06 ) .


Furthermore , plasma intestinal fatty acid binding protein levels were attenuated during exercise after L-citrulline supplementation compared with that in placebo ( AUC0-60 min , -185 % 506 % vs 1318 % 553 % , P < 0.01 ) .


No significant differences were observed for intestinal permeability .


Pre-exercise L-citrulline intake preserves splanchnic perfusion and attenuates intestinal injury during exercise in athletes compared with placebo , probably by enhancing arginine availability .


These results suggest that oral L-citrulline supplementation is a promising intervention to combat splanchnic hypoperfusion-induced intestinal compromise .


Vitamin D supplementation is recommended for breastfed infants .


Maternal supplementation beginning in gestation is a potential alternative , but its efficacy in maintaining infant 25-hydroxyvitamin D [ 25 ( OH ) D ] concentration after birth is unknown .


We determined the effect of 3 doses of maternal vitamin D supplementation beginning in gestation and continued in lactation on infant serum 25 ( OH ) D and compared the prevalence of infant serum 25 ( OH ) D cutoffs ( > 30 , > 40 , > 50 , and > 75 nmol/L ) by dose at 8 wk of age .


Pregnant women ( n = 226 ) were randomly allocated to receive 10 , 25 , or 50 g vitamin D/d from 13 to 24 wk of gestation until 8 wk postpartum , with no infant supplementation .


Mother and infant blood was collected at 8 wk postpartum .


At 8 wk postpartum , mean [ nmol/L ( 95 % CI ) ] infant 25 ( OH ) D at 8 wk was higher in the 50-g/d [ 75 ( 67 , 83 ) ] than in the 25-g/d [ 52 ( 45 , 58 ) ] or 10-g/d [ 45 ( 38 , 52 ) ] vitamin D groups ( P < 0.05 ) .


Fewer infants born to mothers in the 50-g/d group had a 25 ( OH ) D concentration < 30 nmol/L ( indicative of deficiency ) than infants in the 25 - and 10-g/d groups , respectively ( 2 % compared with 16 % and 43 % ; P < 0.05 ) .


Fewer than 15 % of infants in the 10 - or 25-g/d groups achieved a 25 ( OH ) D concentration > 75 nmol/L compared with 44 % in the 50-g/d group ( P < 0.05 ) .


Almost all infants ( 98 % , n = 44 ) born to mothers in the 50-g/d group achieved a 25 ( OH ) D concentration > 30 nmol/L .


At 8 wk postpartum , mean maternal 25 ( OH ) D concentration was higher in the 50-g/d [ 88 ( 84 , 91 ) ] than in the 25-g/d [ 78 ( 74 , 81 ) ] or 10-g/d [ 69 ( 66 , 73 ) ] groups ( P < 0.05 ) .


Maternal supplementation beginning in gestation with 50 g vitamin D/d protects 98 % of unsupplemented breastfed infants against 25 ( OH ) D deficiency ( < 30 nmol/L ) to at least 8 wk , whereas 10 or 25 g vitamin D/d protects only 57 % and 84 % of infants , respectively .


The MIRCIT trial was a randomized , double-blind , placebo-controlled study of advanced Non-small cell lung cancer ( NSCLC ) .


Patients were randomized to receive 10 mg or 20 mg of melatonin or placebo .


Assessment of health-related quality of life ( HRQoL ) was completed at baseline , and at 2 , 3 and 7 months .


Survival and adverse events were collected .


DNA damage marker 8-oxo-7 ,8 - dihydro-2 ' - deoxyguanosine ( 8-oxodG ) was measured during the first three months of chemotherapy .


Patients in the melatonin-treated group had better adjusted HRQoL scores , with a slightly significantly better score ( 2.69 points , 95 % confidence interval ( CI ) = 0.01-5 .38 , p = 0.049 ) being found in social well-being .


Median survival was 7.3 months ( 95 % CI = 3.42-11 .14 ) without significant difference .


A great amont of DNA damage marker was observed in the placebo-treated group , and this was associated with lower survival ( r ( 2 ) = -0.656 , p = 0.02 ) , implying the protective effect of melatonin in healthy cells .


Melatonin in combination with chemotherapy did not affect survival and adverse events of advanced patients with NSCLC , but there was a trend for better HRQoL .


Modifiable risk factors , including life-style habits and psychological variables , have been increasingly demonstrated to have an important role in influencing morbidity and mortality in cardiovascular patients , and to account for approximately 90 % of the population risk for cardiac events.Acceptance and Commitment Therapy ( ACT ) has shown effectiveness in promoting healthy behaviors , and improving psychological well-being in patients with chronic physical conditions .


Moreover , a first application of an acceptance-based program in cardiac patients has revealed high treatment satisfaction and initial evidences of effectiveness in increasing heart-healthy behaviour .


However , no clinical trial to date has evaluated the efficacy of an acceptance-based program for the modification of cardiovascular risk factors and the improvement of psychological well-being , compared to usual secondary prevention care .


Approximately 168 patients will be recruited from an outpatient cardiac rehabilitation unit and randomly assigned to receive usual care or usual care + a brief ACT-based intervention .


The ACT group will be administered five group therapy sessions integrating educational topics on heart-healthy behaviours with acceptance and mindfulness skills .


Participants will be assessed at baseline , six weeks later ( post treatment for the ACT condition ) , at six and twelve months follow-up .


A partially-nested design will be used to balance effects due to clustering of participants into small therapy groups .


Primary outcome measures will include biological indicators of cardiovascular risk and self-reported psychological well-being .


Treatment effects will be tested via multilevel modeling after which the mediational role of psychological flexibility will be evaluated .


The ACTonHEART study is the first randomized clinical trial designed to evaluate the efficacy of a brief group-administered , ACT-based program to promote health behavior change and psychological well-being among cardiac patients .


Results will address the effectiveness of a brief treatment created to simultaneously impact multiple cardiovascular risk factors .


Conducted in the context of clinical practice , this trial will potentially offer empirical support to alternative interventions to improve quality of life and reduce mortality and morbidity rates among cardiac patients .


clinicaltrials.gov / ( NCT01909102 ) .


Compensatory responses may attenuate the effectiveness of exercise training in weight management .


The aim of this study was to compare the effect of moderate - and high-intensity interval training on eating behavior compensation .


Using a crossover design , 10 overweight and obese men participated in 4-week moderate ( MIIT ) and high ( HIIT ) intensity interval training .


MIIT consisted of 5-min cycling stages at 20 % of mechanical work at 45 % VO ( 2 ) peak , and HIIT consisted of alternate 30-s work at 90 % VO ( 2 ) peak and 30-s rests , for 30 to 45 min .


Assessments included a constant-load exercise test at 45 % VO ( 2 ) peak for 45 min followed by 60-min recovery .


Appetite sensations were measured during the exercise test using a Visual Analog Scale .


Food preferences ( liking and wanting ) were assessed using a computer-based paradigm , and this paradigm uses 20 photographic food stimuli varying along two dimensions , fat ( high or low ) and taste ( sweet or nonsweet ) .


An ad libitum test meal was provided after the constant-load exercise test .


Exercise-induced hunger and desire to eat decreased after HIIT , and the difference between MIIT and HIIT in desire to eat approached significance ( p = .07 ) .


Exercise-induced liking for high-fat nonsweet food tended to increase after MIIT and decreased after HIIT ( p = .09 ) .


Fat intake decreased by 16 % after HIIT , and increased by 38 % after MIIT , with the difference between MIIT and HIIT approaching significance ( p = .07 ) .


This study provides evidence that energy intake compensation differs between MIIT and HIIT .


To determine if lower extremity exercise-induced muscle injury reduces vascular endothelial function of the upper extremity and if massage therapy ( MT ) improves peripheral vascular function after exertion-induced muscle injury .


Randomized , blinded trial with evaluations at 90 minutes , 24 hours , 48 hours , and 72 hours .


Clinical research center .


Sedentary young adults ( N = 36 ) were randomly assigned to 1 of 3 groups : ( 1 ) exertion-induced muscle injury and MT ( n = 15 ; mean age SE , 26.6 0.3 ) ; ( 2 ) exertion-induced muscle injury only ( n = 10 ; mean age SE , 23.6 0.4 ) , and ( 3 ) MT only ( n = 11 ; mean age SE , 25.5 0.4 ) .


Participants were assigned to exertion-induced muscle injury only ( a single bout of bilateral , eccentric leg press exercise ) , MT only ( 30-min lower extremity massage using Swedish technique ) , or exertion-induced muscle injury and MT.


Brachial artery flow-mediated dilation ( FMD ) was determined by ultrasound at each time point .


Nitroglycerin ( NTG ) - induced dilation was also assessed ( 0.4 mg ) .


Brachial FMD increased from baseline in the exertion-induced muscle injury and MT group and the MT only group ( 7.38 % .18 % to 9.02 % .28 % , P < .05 and 7.77 % .25 % to 10.2 % .22 % , P < .05 , respectively ) at 90 minutes and remained elevated until 72 hours .


In the exertion-induced muscle injury only group , FMD was reduced from baseline at 24 and 48 hours ( 7.78 % .14 % to 6.75 % .11 % , P < .05 and 6.53 % .11 % , P < .05 , respectively ) and returned to baseline after 72 hours .


Dilations of NTG were similar over time .


Our results suggest that MT attenuates impairment of upper extremity endothelial function resulting from lower extremity exertion-induced muscle injury in sedentary young adults .


In research clinic settings , overweight adults undertaking HIIT ( high intensity interval training ) improve their fitness as effectively as those undertaking conventional walking programs but can do so within a shorter time spent exercising .


We undertook a randomized controlled feasibility ( pilot ) study aimed at extending HIIT into a real world setting by recruiting overweight/obese , inactive adults into a group based activity program , held in a community park .


Participants were allocated into one of three groups .


The two interventions , aerobic interval training and maximal volitional interval training , were compared with an active control group undertaking walking based exercise .


Supervised group sessions ( 36 per intervention ) were held outdoors .


Cardiorespiratory fitness was measured using VO2max ( maximal oxygen uptake , results expressed in ml/min/kg ) , before and after the 12 week interventions .


On ITT ( intention to treat ) analyses , baseline ( N = 49 ) and exit ( N = 39 ) [ Formula : see text ] O2 was 25.34.5 and 25.33.9 , respectively .


Participant allocation and baseline/exit VO2max by group was as follows : Aerobic interval training N = 16 , 24.24.8 / 25.64.8 ; maximal volitional interval training N = 16 , 25.02.8 / 25.23.4 ; walking N = 17 , 26.55.3 / 25.23.6 .


The post intervention change in VO2max was +1.01 in the aerobic interval training , -0.06 in the maximal volitional interval training and -1.03 in the walking subgroups .


The aerobic interval training subgroup increased VO2max compared to walking ( p = 0.03 ) .


The actual ( observed , rather than prescribed ) time spent exercising ( minutes per week , ITT analysis ) was 74 for aerobic interval training , 45 for maximal volitional interval training and 116 for walking ( p = 0.001 ) .


On descriptive analysis , the walking subgroup had the fewest adverse events .


In contrast to earlier studies , the improvement in cardiorespiratory fitness in a cohort of overweight/obese participants undertaking aerobic interval training in a real world setting was modest .


The most likely reason for this finding relates to reduced adherence to the exercise program , when moving beyond the research clinic setting .


ACTR.org.au ACTRN12610000295044 .


In experimental animal studies , pulsing the CO2 laser beam has been shown to reduce the thermal damage zone of excised oral mucosal tissue .


However , there is still controversy over whether this is borne out under clinical conditions .


To compare the outcome following excisional biopsies of fibrous hyperplasias using a pulsed ( cf ) versus a continuous wave ( cw ) CO2 laser mode regarding the thermal damage zone , duration of surgeries , intra - and postoperative complications , postoperative pain sensation , scarring and/or relapse during the initial 6 months .


One hundred Swiss-resident patients with a fibrous hyperplasia in their buccal mucosa were randomly assigned to the cw mode ( 5W ) or the cf mode ( 140Hz , 400microseconds , 33mJ , 4.62 W ) group .


All excisions were performed by one single oral surgeon .


Postoperative pain ( 2 weeks ) was recorded by visual analogue scale ( VAS ; ranging from 0 to 100 ) .


Intake of analgesics and postoperative complications were recorded in a standardized study form .


The maximum width of the collateral thermal damage zone was measured ( m ) in excision specimens by one pathologist .


Intraoral photographs at 6-month follow-up examinations were evaluated regarding scarring ( yes/no ) .


Median duration of the excision was 65seconds in the cw and 81seconds in the cf group ( P = 0.13 ) .


Intraoperative bleeding occurred in 16.3 % of the patients in the cw and 17.7 % of the cf group .


The median value of the thermal damage zone was 161 ( 228 ) m in the cw and 152 ( 105 ) m in the cf group ( P = 0.68 ) .


The reported postoperative complications included swelling in 19 % and minor bleeding in 6 % without significant differences between the two laser modes .


When comparing each day separately or the combined mean VAS scores of both groups between Days 1-3 , 1-7 , and 1-15 , there were no significant differences .


However , more patients of the cw group ( 25 % ) took analgesics than patients of the cf group ( 9.8 % ) resulting in a borderline significance ( P = 0.04 ) .


Scarring at the excision site was found in 50.6 % of 77 patients after 6 months , and more scars were identified in cases treated with the cf mode ( P = 0.03 ) .


Excision of fibrous hyperplasias performed with a CO2 laser demonstrated a good clinical outcome and long-term predictability with a low risk of recurrence regardless of the laser mode ( cf or cw ) used .


Scarring after 6 months was only seen in 50.6 % of the cases and was slightly more frequent in the cf mode group .


Based on the findings of the present study , a safety border of 1mm appears sufficient for both laser modes especially when performing a biopsy of a suspicious soft tissue lesion to ensure a proper histopathological examination .


Patients with chronic kidney disease ( CKD ) show an increase in bowel aerobic bacteria that produce uremic toxins and decreased anaerobic bacteria as bifidobacteria and lactobacillus .


The latter can be used as probiotics .


The probiotic with greater availability in Mexico , is the lactobacillus casei shirota ( LcS ) , currently there is no known LcS specified dose that produces a benefit to the patient with CKD .


To determine the effectiveness of two different LcS doses in achieving a decrease in urea concentrations of at least 10 % in patients with KDOQI stage 3 and stage 4 CKD .


METODOLOGY : A simple randomized , controlled clinical trial .


Outpatients treated at the National Institute of Medical Sciences and Nutrition Salvador Zubirn in Mxico D.F. Patients were provided the LcS , as follows : Group A : 8 x 10 ( 9 ) colony-forming units ( CFU ) and Group B : 16 x 10 ( 9 ) CFU .


Patients were followed-up for eight weeks , and baseline and final samples were obtained to calculate the basal and final concentrations , respectively , of blood urea and serum creatinine ( CrS ) .


During the follow-up , both groups consumed a diet of 30 kcal/kg/weight and 0.8 g/kg/weight of protein , and a food diary was made to assess both the adherence to the diet and LcS .


Thirty patients with CKD were evaluated .


When analyzing the percentage change between the different doses , a decrease > 10 % was found in the blood urea concentrations for patients treated with the 16 x 109 dose , which was significant with respect to the baseline measurement .


There was a > 10 % decrease in the serum urea concentrations with LcS in patients with stage 3 and 4 CRF .


SCN1A encodes the alpha subunit of the voltage-gated sodium channel and plays a crucial role in several epilepsy syndromes .


The common SCN1A splice-site polymorphism rs3812718 ( IVS5N +5 G > A ) might contribute to the pathophysiology underlying genetic generalized epilepsies and is associated with electrophysiologic properties of the channel and the effect of sodium-channel blocking antiepileptic drugs .


We assessed the effects of the rs3812718 genotype on cortical excitability at baseline and after administration of carbamazepine in order to investigate the mechanism of this association .


Paired-pulse transcranial magnetic stimulation ( TMS ) was applied in 92 healthy volunteers with the homozygous genotypes AA or GG of rs3812718 at baseline and after application of 400mg of carbamazepine or placebo in a double-blind , randomized , crossover design .


Resting motor threshold ( RMT ) , short interval intracortical inhibition ( SICI ) , intracortical facilitation ( ICF ) , and cortical silent period ( CSP ) were determined .


At baseline there was no significant difference in any TMS parameter .


Genotype GG was associated with a higher carbamazepine-induced increase in CSP duration as compared to AA ( multivariate analysis of covariance [ MANCOVA ] , p = 0.013 ) .


An expected significant increase in RMT was genotype independent .


We found that the rs3812718 genotype modifies the effect of carbamazepine on CSP duration ( mainly reflecting modulation of - aminobutyric acid ( GABA ) ergic inhibition ) , but not on RMT ( mainly reflecting modulation of voltage-gated sodium channels ) .


This provides evidence that rs3812718 affects the pharmacoresponse to carbamazepine via an effect on GABAergic cortical interneurons .


Our results also confirm that TMS is useful to investigate the effect of genetic variants on cortical excitability and pharmacoresponse .


We evaluate whether aspiration and sclerosing of hydrocele testis is an effective treatment .


Men with symptomatic hydrocele testis were included in this prospective , double-blind , randomized study with polidocanol and placebo .


Patients were randomized to active treatment or placebo at the first treatment .


Depending on hydrocele testis size ( less than 100 , 100 to 200 and greater than 200 ml ) , the patients were treated with 1 , 3 or 4 ml polidocanol after aspiration .


Patients with recurrence at the 5-week followup received active treatment .


A total of 77 patients were included in the study .


In group 1 ( active treatment ) there were 36 patients with a median age of 63 years ( range 34 to 92 ) .


In group 2 , comprised of 41 patients , the median age was 59 years ( range 26 to 82 ) .


Median followup was 72 months .


A significant difference between the groups was observed after the first and second treatments .


Recurrence after the first treatment was seen in 16 ( 44 % ) patients from group 1 and in 32 ( 78 % ) from group 2 ( p < 0.05 ) .


Recurrence after re-treatment with the active drug in both groups was seen in 4 ( 25 % ) patients in group 1 and in 14 ( 44 % ) in the former placebo group ( p < 0.05 ) .


The overall success rate of treatment in the active group was 89 % .


There was no difference between the 2 groups in terms of volume of fluid aspirated , symptoms or complications .


This long-term efficacy randomized study with placebo showed that polidocanol is effective for the treatment of hydrocele testis with a low recurrence rate .


Although hypertension is a modifiable cardiovascular risk factor , up to one-third of ambulatory patients have uncontrolled blood pressure ( BP ) .


We evaluated the impact of a targeted provider feedback intervention on rates of BP control .


Clinic BP readings were aggregated among approximately 3,000 hypertensive patients followed up in 42 outpatient cardiology clinic practices at a large quaternary care academic medical center .


Physician practices received quarterly reports on BP control rates .


Provider-specific reports were benchmarked vs overall peer performance and distributed quarterly between September 2011 and September 2012 .


Rates of BP control were evaluated before and after the intervention .


Medical record reviews were performed for a subset of patients with uncontrolled BP before ( n = 300 ) and after ( n = 300 ) the intervention to evaluate provider responses and interventions .


At baseline , 27.9 % of clinic patients had uncontrolled BP .


After one 1 of reports , the rate of uncontrolled BP remained unchanged ( 27.7 % , P = .86 ) .


Analysis of provider performance revealed a subset of providers who consistently outperform their peers .


In the sample of patients selected for medical record reviews , at baseline ( n = 300 ) and follow-up ( n = 300 ) , cardiologists discussed BP in 80 % of clinic notes for patients with uncontrolled BP .


Cardiologists more frequently documented repeat measurements after the intervention ( 28.0 % vs 35.7 % , P = .04 ) .


No other changes were found in documentation of provider responses to BP .


Clinician-specific audit and feedback reports as a stand-alone intervention did not affect overall BP control rates in cardiology clinics .


Future BP control interventions should consider real-time patient-specific reminders , provider incentive programs , and patient engagement interventions .


The object of this study was to assess the effects of an inside-out vein graft as a cuff after direct suture on human lingual nerve regeneration and recovery after iatrogenic lingual nerve injury .


Ten patients with unilateral lingual nerve anesthesia as a complication of iatrogenic injury after third molar extraction underwent microneurosurgical procedures for the injured lingual nerve under general anesthesia .


The patients were randomized into 2 groups .


In group A , after removing the neuromas and peripheral scars surrounding the torn nerves , the 2 nerve ends were sutured without tension .


In group B , after the same procedure , including the same suturing procedure , an inside-out vein graft was placed as a cuff after the direct suture .


Each group was followed at least once every 6 months for 1 year after the procedure .


Postoperative outcomes were evaluated using the Pogrel criteria , the Sunderland grade , and the British Medical Research Council Scale ( MRCS ) .


There were no particular differences between groups A and B at 6 and 12 months after the operation .


However , based on the MRCS criteria , there was a clearly better result in group B than in group A at 6 and 12 months after the operation , and the recovery of gustatory sensation tended to be better in group B than in group A 1 year after the operation .


This inside-out vein graft as a cuff after direct suturing may facilitate faster lingual nerve regeneration than the traditional direct suture approach .


The inside-out vein graft as a cuff may provide the advantages of preventing axonal escape at the suture lines , minimizing nerve entrapment , and preventing neuroma formation in the space between the sutured nerves .


Primary percutaneous coronary intervention has improved the outcome of acute myocardial infarction ( AMI ) patients .


Counsel-guided sex rehabilitation efficacy in acute myocardial infarction patients receiving percutaneous coronary intervention remains unknown .


The aim of the study was to study counsel-guided sex rehabilitation efficacy in AMI patients receiving percutaneous coronary intervention .


240 AMI patients who received percutaneous coronary intervention were randomly divided into a control and a counselling group .


Control group patients were given written sex rehabilitation instruction before discharge , while counselling group patients were given written instruction before discharge and monthly counselling with healthcare providers .


Before discharge , the first evaluation was performed for frequency of and satisfaction with sexual activity before AMI .


At one year of follow-up , the time of resuming , frequency of and satisfaction with sexual activity was evaluated .


The main adverse event rates were also investigated .


No significant differences in age , sex , smoking status , hypertension , diabetes , PVD ( peripheral vascular disease ) , EF ( ejection fraction ) or GRACE ( Global Registry of Acute Coronary Events ) score were found between the groups .


Both groups suffered reduced frequency of and satisfaction with sexual activity after AMI as compared with prior to presentation with AMI .


However , compared with controls , the counselling group had higher scores for frequency of and satisfaction with sexual activity after AMI .


The time to resume sexual activity after AMI in the counselling group was significantly shorter than was found for the control group.There were no significant differences between the groups for recurrent AMI , non-fatal stroke , admitting the patient for angina , all-cause death or adverse events .


Intermittent discussions between healthcare providers and AMI patients improved resumption of sexual activity .


Encouraging patients who received complete coronary revascularization to resume sexual activity shortly after AMI was safe .


To identify the effects of anti-angiogenic therapy in neovascular age-related macular degeneration ( AMD ) in respect to morphologic type and time course and to identify prognostic factors for visual outcome on the basis of standardized optical coherence tomography ( OCT ) analysis .


Subanalysis of a prospective , 12-month , multicenter , phase IIIb trial ( Efficacy and Safety of Ranibizumab in Patients with Subfoveal Choroidal Neovascularization Secondary to Age-Related Macular Degeneration [ EXCITE ] ) .


A total of 353 treatment-nave patients with subfoveal choroidal neovascularization ( CNV ) receiving quarterly or monthly ranibizumab therapy .


Patients were randomized to receive 0.3 mg quarterly , 0.5 mg quarterly , or 0.3 mg monthly doses of ranibizumab .


Treatment comprised a loading phase of 3 consecutive monthly injections followed by a 9-month maintenance phase of monthly or quarterly injections .


Best-corrected visual acuity ( BCVA ) was measured using the Early Treatment Diabetic Retinopathy Study protocol , and retinal morphology was assessed by Stratus OCT ( Carl Zeiss Meditec , Dublin , CA ) .


Imaging data were evaluated by certified examiners of the Vienna Reading Center using a standardized protocol .


The BCVA was measured using ETDRS charts and retinal morphology was assessed by OCT. .


During the loading phase , there was a significant correlation between a reduction in central retinal thickness and an increase in BCVA ( P < 0.001 ) , which decreased during the maintenance phase in all treatment arms .


The proportion of patients showing retinal morphologic changes , such as intraretinal cysts ( IRCs ) , subretinal fluid ( SRF ) , and pigment epithelial detachments ( PEDs ) , decreased significantly in all groups ( P < 0.001 ) , more intensively in the 0.5 mg quarterly than in both 0.3 mg groups .


Intraretinal cysts resolved most rapidly followed by SRF , whereas PED decreased at a slower rate and intensity .


Patients with IRC at baseline had lower BCVA levels that remained lower over the entire study period , whereas recurrence of IRC during follow-up showed no additional negative effect on function .


Baseline SRF had no effect on visual recovery ; however , recurrence of SRF during follow-up showed a tendency for an additional negative effect on function ( P = 0.06 ) .


Baseline PED showed a negative influence on visual outcome only in combination with IRC and SRF .


There is a distinct response pattern and time course of morphologic parameters associated withanti-vascular endothelial growth factor therapy in neovascular AMD .


Specific alterations , such as IRC , SRF , andPED , as baseline or follow-up features are significantly influencing the potential for visual gain .


There is ongoing controversy regarding a ` J-curve ' phenomenon such that low and high blood pressure ( BP ) levels are associated with increased risks of recurrent stroke .


We aimed to determine whether large treatment-related BP reductions are associated with increased risks of recurrent stroke .


Data are from the PROGRESS trial , where 6105 patients with cerebrovascular disease were randomly assigned to either active treatment ( perindopril indapamide ) or placebo ( s ) .


There were no BP criteria for entry .


BP was measured at every visit , and participant groups defined by reduction in systolic BP ( SBP ) from baseline were used for the analyses .


Outcome was recurrent stroke .


During a mean follow-up of 3.9 years , 727 recurrent strokes were observed .


There were clear associations between the magnitude of SBP reduction and the risk of recurrent stroke .


After adjustment for cardiovascular risk factors and randomised treatment , annual incidence was 2.08 % , 2.10 % , 2.31 % and 2.96 % for participant groups defined by SBP reductions of 20 , 10-19 , 0-9 and < 0 mm Hg , respectively ( p = 0.0006 for trend ) .


The present analysis provided no evidence of an increase in recurrent stroke associated with larger reductions in SBP produced by treatment among patients with cerebrovascular disease .


To evaluate and compare the effect of triphala extract mouthrinse and chlorhexidine on dental plaque and gingivitis .


In this double blind , crossover study , 120 qualifying boarding-school students aged 13-16 years were randomised into three groups : 10 % triphala , 0.2 % chlorhexidine and negative control .


The study was conducted in 3 phases of 1-month duration each and a washout period of 15 days .


During the experimental period , subjects rinsed with the allocated mouthrinse once daily for 30 s under supervision .


The plaque and gingival status was assessed using the Turesky modification of the Quigley and Hein plaque index ( QHI ) and the gingival index ( Le and Silness ) at baseline and at the end of each phase .


The results were tested for significance at P < 0.05 .


Triphala and chlorhexidine yielded a significant reduction in plaque and gingival index scores as compared to negative control ( P < 0.001 ) .


No significant difference was found between the scores obtained with triphala and chlorhexidine mouthwashes .


The antiplaque and antigingivitis activity of triphala closely parallels that of chlorhexidine .


Placental growth factor ( PlGF ) has been implicated as a contributor to resistance against anti-VEGF therapy .


The purpose of the present study was to analyze the systemic levels of PlGF , VEGF-A , and VEGF-B in patients with neovascular age-related macular degeneration ( AMD ) after treatment with aflibercept , ranibizumab , or bevacizumab .


Totals of 19 patients were treated with intravitreal aflibercept , 19 with ranibizumab , and 18 with bevacizumab .


The cytokine levels were measured by ELISA just before the injection , and 7 days and 1 month thereafter .


Age - and sex-matched participants ( n = 22 ) served as controls .


The median PlGF plasma concentration at baseline was < 12.0 pg/mL in the control group as well as in all three anti-VEGF treatment cohorts .


After intravitreal aflibercept injection , a significant upregulation of systemic PlGF could be observed in all treated patients ( 38.0 [ 31.0-44 .0 ] pg/mL after 1 week [ P < 0.001 ] and 16.0 [ 0.0-19 .0 ] pg/mL [ P = 0.005 ] after 4 weeks ) .


No significant effects on plasma PlGF concentrations could be detected in those treated with ranibizumab and bevacizumab .


The systemic VEGF-A levels were significantly reduced 1 and 4 weeks after intravitreal aflibercept ( P < 0.001 , P < 0.001 ) and bevacizumab ( P < 0.001 , P < 0.01 ) injections .


No significant effects on plasma cytokine concentrations could be observed in the ranibizumab cohort .


No significant effects on systemic VEGF-B could be observed in any of the treatment groups .


In this study , we report a significant systemic upregulation of the proangiogenic cytokine PlGF after intravitreal administration of aflibercept .


This might represent a counter-regulatory response to antiangiogenic therapy .


To determine the influence of arm-crank exercise in reproductive hormone levels in adults with chronic SCI .


Further objectives were to assess the influence of arm-crank exercise on muscle strength and body composition .


Seventeen male adults with complete SCI at or below the 5th thoracic level ( T5 ) volunteered for this study .


Participants were randomly allocated to the intervention ( n = 9 ) or control group ( n = 8 ) using a concealed method .


The participants in the intervention group performed a 12-week arm-crank exercise program , 3 sessions/week , consisting of warming-up ( 10-15 min ) followed by a main part in arm-crank ( 20-30 min [ increasing 2 min and 30 seconds each three weeks ] ) at a moderate work intensity of 50-65 % of heart rate reserve ( HRR ) ( starting at 50 % and increasing 5 % each three weeks ) and by a cooling-down period ( 5-10 min ) .


Serum follicle-stimulating hormone ( FSH ) , luteinizing hormone ( LH ) , testosterone and estradiol were determined by ELISA .


Muscle strength ( handgrip ) and body composition ( waist circumference [ WC ] ) were assessed .


After the completion of the training program , testosterone level was significantly increased ( p = 0.0166 ;d = 1.14 ) .


Furthermore , maximal handgrip and WC were significantly improved .


Lastly , a significant inverse correlation was found between WC and testosterone ( r = - 0.35 ; p = 0.0377 ) .


The arm-crank exercise improved reproductive hormone profile by increasing testosterone levels in adults with chronic SCI .


A secondary finding was that it also significantly improved muscle strength and body composition in this group .


Scleral gas-permeable lenses are rapidly gaining international popularity .


Unlike corneal gas-permeable lenses , scleral lenses are fitted to the bulbar conjunctiva and settle into the tissue after insertion .


To date , we are unaware of any studies examining the settling behavior of three varying scleral lens designs .


The purpose of this study was to quantify the mean total settling and mean rates of settling for three scleral lens designs : Onefit P&A ( Blanchard Contact Lens , Inc ) , Mini Scleral Design ( msd ) ( Blanchard Contact Lens , Inc ) , and Jupiter ( Visionary Optics ) .


A randomized , repeated-measures study of Onefit P&A , msd , and Jupiter was performed .


Subjects were fitted from a trial lens set , according to the manufacturer 's guidelines .


After insertion , lens settling was measured at 0 minutes , 15 minutes , 30 minutes , 45 minutes , 1 hour , 2 hours , 4 hours , 6 hours , and 8 hours .


Statistical analyses were performed using analysis of variance and two-stage , nonlinear regression analyses of settling over time .


On average , the Onefit P&A , msd , and Jupiter lenses settled a total of 113.7 , 133.7 , and 88.1 m , respectively .


Although the rates of settling were not linear , analysis of variance revealed a significant difference in the average settling rates ( p < 0.05 ) among the groups .


Tukey analyses revealed a significant difference in the settling rates for msd and Jupiter comparison ( p < 0.05 ) .


Nonlinear regression analyses predicted that the lenses settled to about 80 % of the final estimated values for the Onefit P&A lens , 90 % for msd , and 99 % for the Jupiter , after 8 hours .


We concluded that the amount of settling varied significantly among the three lens designs .


Settling rates were greatest shortly after insertion .


Larger lenses were estimated to be settled by 8 hours .


Based on the results of this short-term study , careful consideration to the settling patterns of individual scleral lens designs should be given .


A healthy lifestyle may protect against cognitive decline .


We examined outcomes in elderly individuals after 18 months of a five-group intervention program consisting of various modalities to prevent cognitive decline .


We conducted a cluster randomized controlled trial assessing 460 community-dwelling individuals aged 60 years and older in a geriatric community mental health center in Suwon , Republic of Korea , between 2008 and 2010 .


We developed an intervention program based on the principles of contingency management , which could be delivered by ordinary primary health workers .


Group A ( n = 81 ) received standard care services .


Group B ( n = 80 ) received bimonthly ( once every 2 months ) telephonic care management .


Group C ( n = 111 ) received monthly telephonic care management and educational materials similar to those in group B. Group D ( n = 93 ) received bimonthly health worker-initiated visits and counseling .


Group E ( n = 94 ) received bimonthly health worker-initiated visits , counseling , and rewards for adherence to the program .


The primary outcome was the change in Mini-Mental State Examination ( MMSE ) scores from baseline to the final follow-up visit at 18 months .


Group E showed superior cognitive function to group A ( adjusted coefficient = 0.99 , p = 0.044 ) , with participation in cognitive activities being the most important determining factor among several health behaviors ( adjusted coefficient = 1.04 , p < 0.01 ) .


Engaging in cognitive activities , in combination with positive health behaviors , may be most beneficial in preserving cognitive abilities in community-dwelling older adults .


Omalizumab , an anti-IgE monoclonal antibody , is administered by injection once or twice monthly in offices and clinics .


It offers a potential alternative intervention for patients with allergic asthma that is not well controlled because of recalcitrant poor adherence to inhaled corticosteroid therapy .


To assess the effect of omalizumab therapy by measuring airway responsiveness to adenosine , a marker of allergic airway inflammation , and resource use .


Patients ( N = 17 ) aged 6 to 26 years ( mean age , 16.4 years ) with poorly controlled persistent allergic asthma , less than 50 % adherence to inhaled corticosteroid therapy , a forced expiratory volume in 1 second ( FEV1 ) of 60 % predicted or higher , and adenosine provocation concentration that caused a decrease in FEV1 of 20 % ( PC20 ) of 60 mg/mL or less were randomized to receive 4 months of omalizumab or placebo in a double-blind , crossover trial with a 3 - to 4-month washout between treatments .


Patients were instructed to continue taking inhaled corticosteroids throughout the study .


The PC20 was measured before and after each period .


Fifteen patients completed the study .


The mean baseline PC20 was 14.1 mg/mL ( 95 % CI , 10.8-18 .4 mg/mL ) .


The fold change PC20 was 0.9 ( 95 % CI , 0.5-1 .7 ) during placebo and 3.1 ( 95 % CI , 1.6-6 .2 ) during omalizumab treatment ; the estimated ratio was 3.4 ( 95 % CI , 1.2-9 .3 ; P = .02 ) .


Six patients required one or more short courses of oral corticosteroids for asthma exacerbations during placebo , but none required this intervention during omalizumab .


During the study , the median prescription refills for inhaled corticosteroids was 0.15 ( 95 % CI , 0.00-0 .33 ) canisters per month .


Omalizumab therapy is an alternative for patients with more severe poorly controlled asthma in whom adherence does not improve with conventional interventions .


clinicaltrials.gov Identifier : NCT00133042 .


To evaluate visual acuity outcomes after cataract surgery in persons with varying degrees of severity of age-related macular degeneration ( AMD ) .


Cohort study .


A total of 1232 eyes of 793 participants who underwent cataract surgery during the Age-Related Eye Disease Study 2 , a prospective , multicenter , randomized controlled trial of nutritional supplements for treatment of AMD .


Preoperative and postoperative characteristics of participants who underwent cataract extraction during the 5-year trial were analyzed .


Both clinical data and standardized red-reflex lens and fundus photographs were obtained at baseline and annually .


Photographs were graded by a centralized reading center for cortical and posterior subcapsular lens opacities and for AMD severity .


Cataract surgery was documented at annual study visits or by history during the 6-month telephone calls .


Analyses were conducted using multivariate repeated-measures regression .


Change in best-corrected visual acuity ( BCVA ) after cataract surgery compared with preoperative BCVA .


Adjusting for age at time of surgery , gender , interval between preoperative and postoperative visits , and type and severity of cataract , the mean changes in visual acuity were as follows : eyes with mild AMD ( n = 30 ) gained 11.2 letters ( 95 % confidence interval [ CI ] , 6.9-15 .5 ) , eyes with moderate AMD ( n = 346 ) gained 11.1 letters ( 95 % CI , 9.1-13 .2 ) , eyes with severe AMD ( n = 462 ) gained 8.7 letters ( 95 % CI , 6.7-10 .7 ) , eyes with noncentral geographic atrophy ( n = 70 ) gained 8.9 letters ( 95 % CI , 5.8-12 .1 ) , and eyes with advanced AMD ( central geographic atrophy , neovascular disease , or both ; n = 324 ) gained 6.8 letters ( 95 % CI , 4.9-8 .8 ) .


The visual acuity gain across all AMD severity groups was statistically significant from preoperative values ( P < 0.0001 ) .


Mean visual acuities improved significantly after cataract surgery across varying degrees of AMD severity .


The objective of this study is to compare the effects of 2 types of diuretics , indapamide and hydrochlorothiazide , added to an angiotensin-converting enzyme inhibitor , on ventricular and arterial functions in patients with hypertension and diabetes .


This is a prospective , randomized , active-controlled , PROBE design study in 56 patients ( 57 9 years , 52 % men ) with mild-to-moderate hypertension and type 2 diabetes , with normal ejection fraction , randomized to either indapamide ( 1.5 mg Slow Release ( SR ) / day ) or hydrochlorothiazide ( 25 mg/d ) , added to quinapril ( 10-40 mg/d ) .


All patients had conventional , tissue Doppler and speckle tracking echocardiography and assessment of endothelial and arterial functions and biomarkers , at baseline and after 6 months .


Baseline characteristics were similar between groups ; systolic and diastolic blood pressures decreased similarly , by 15 % and 9 % on indapamide and by 17 % and 10 % on hydrochlorothiazide ( P < .05 ) .


Mean longitudinal systolic velocity and longitudinal strain increased by 7 % and 14 % on indapamide ( from 5.6 1.8 to 6.0 1.1 cm/s and from 16.2 % 1.8 % to 18.5 % 1.1 % , both P < .05 ) , but did not change on hydrochlorothiazide ( P < .05 for intergroup differences ) , whereas ejection fraction and radial systolic function did not change .


Similarly , mean longitudinal early diastolic velocity increased by 31 % on indapamide ( P < .05 ) , but did not change on hydrochlorothiazide ( P < .05 for intergroup differences ) .


These changes were associated with improved endothelial and arterial functions on indapamide , but not on hydrochlorothiazide .


Indapamide was found to improve measures of endothelial and arterial functions and to increase longitudinal left ventricular function compared with hydrochlorothiazide in patients with hypertension and diabetes , after 6 months of treatment .


This study suggests that indapamide , a thiazide-like diuretic , has important vascular effects that can improve ventriculoarterial coupling .


There is a strong correlation between adverse clinical events and peak values of myocardial necrosis markers in non-ST-elevation acute coronary syndrome patients .


In this clinical setting , high-dose statin treatment exerts acute beneficial effects against renal and myocardial damage .


The aim of this report was to evaluate if , on admission , high-dose rosuvastatin can exert cardioprotective effects when administered in addition to high-dose clopidogrel .


In the PRATO-ACS trial , 504 consecutive statin-nave non-ST-elevation acute coronary syndrome patients scheduled for early invasive strategy and pretreated with high-dose clopidogrel were randomly assigned to rosuvastatin ( 40 mg on admission followed by 20 mg/d ; statin group , n = 252 ) or no statin treatment ( control group , n = 252 ) .


Serial myocardial biomarker samples were collected before and after angiography and/or percutaneous coronary intervention .


The primary end point was the peak level of cardiac troponin I ( cTnI ) during the index event .


Statin-treated patients presented median cTnI peak values similar to controls ( 3.9 [ 0.6-12 .8 ] vs 3.5 [ 1.2-11 .9 ] ng/mL , respectively ; P = .60 ] ; no differences were found between the 2 groups in cTnI and creatine kinase-MB values at any time point , in either preangiography and postangiography peak values or their cumulative release .


In patients submitted to percutaneous coronary intervention , periprocedural myocardial infarction occurred in 8 ( 4.7 % ) of 171 statin-treated and 7 ( 4.3 % ) of 162 control patients ( P = .87 ) .


In the PRATO-ACS trial , early high-dose rosuvastatin did not show cardioprotective effects when administered in addition to high-dose clopidogrel .


The goal of this study was to evaluate the pharmacodynamic effects of switching patients from ticagrelor to prasugrel .


Clinicians may need to switch between more potent P2Y12 inhibitors because of adverse effects or switch to the use of a once-daily dosing regimen due to compliance issues .


After a 3 - to 5-day run-in phase with a ticagrelor 180-mg loading dose ( LD ) followed by a ticagrelor 90-mg twice-daily maintenance dose ( MD ) , aspirin-treated patients ( N = 110 ) with stable coronary artery disease were randomized to continue ticagrelor or switch to prasugrel 10-mg once-daily MD , with or without a 60-mg LD .


Pharmacodynamic assessments were defined according to P2Y12 reaction unit ( PRU ) ( P2Y12 assay ) and platelet reactivity index ( vasodilator-stimulated phosphoprotein phosphorylation assay ) at baseline ( before and after the run-in phase ) and 2 , 4 , 24 , and 48 h and 7 days after randomization .


Platelet reactivity was significantly greater at 24 and 48 h after switching to prasugrel versus continued therapy with ticagrelor , although to a lesser extent in those receiving an LD .


Mean PRU remained significantly higher in the combined prasugrel groups versus the ticagrelor group ( least-squares mean difference : 46 [ 95 % confidence interval 25 to 67 ] ) and did not meet the primary noninferiority endpoint ( upper limit of the confidence interval 45 ) , although PRU in the prasugrel cohort was lower at 7 days than at 24 or 48 h. Accordingly , rates of high on-treatment platelet reactivity were higher at 24 and 48 h in both prasugrel groups .


At 7 days , there was no difference in high on-treatment platelet reactivity rate between the combined prasugrel and ticagrelor groups .


Compared with continued ticagrelor therapy , switching from ticagrelor to prasugrel therapy was associated with an increase in platelet reactivity that was partially mitigated by the administration of an LD .


Low-density lipoprotein ( LDL ) cholesterol is a strong risk factor for atherosclerosis but has an inverse association with atrial fibrillation ( AF ) .


We aimed to provide insight into the paradoxical association of LDL cholesterol with AF by evaluating the relationship of various lipoprotein measures and incident AF .


We prospectively evaluated lipoprotein measures among 23 738 healthy middle-aged and older women ( median follow-up 16.4 years ; N = 795 incident AF events ) .


Baseline LDL cholesterol was directly measured , lipoprotein particle concentrations and size were measured by nuclear magnetic resonance spectroscopy , and apolipoproteins were measured by immunoassay .


Cox regression models were adjusted for age , AF risk factors , inflammatory , and dysglycemic biomarkers .


After multivariable adjustment , inverse associations with AF were observed ( hazard ratio , 95 % confidence interval for top versus bottom quintile , P value ) for LDL cholesterol ( 0.72 , 0.56-0 .92 , P = 0.009 ) , the total number of LDL particles ( 0.77 , 0.60-0 .99 , P = 0.045 ) , and very-low-density lipoprotein particles ( 0.78 , 0.61-0 .99 , P = 0.04 ) , which was driven by the number of cholesterol-poor small LDL ( 0.78 , 0.61-1 .00 , P = 0.05 ) and small very-low-density lipoprotein particles ( 0.78 , 0.62-0 .99 , P = 0.04 ) .


By contrast , the larger cholesterol-rich LDL particles and all high-density lipoprotein measures were not associated with AF in multivariable models .


Adjustment for inflammatory and dysglycemic biomarkers had minimal impact on these associations .


In this prospective study , the inverse association between LDL cholesterol and AF extended to several other atherogenic lipoproteins , and these associations are unlikely to be mediated by direct cholesterol effects .


ClinicalTrials.gov ; Unique Identifier : NCT00000479 .


To observe the clinical effects of acupoint injection of metoclopramide for postsurgical gastroparesis syndrome ( PGS ) .


A total of 46 patients with PGS ( from abdominal surgery ) were randomly divided into control and acupoint injection groups ( n = 23 in each group ) .


Patients of the acupoint injection group were treated by injection of Metoclopramide ( 5 mg + normal saline ) into bilateral Zusanli ( ST 36 ) and Weishu ( BL 21 ) alternatively , while patients of the control group treated by injection of 10 mg of Metoclopramide into the deltoid muscle and gluteus maximus muscle alternatively .


The treatment of both groups was conducted once daily for 14 days .


A 3-point scale of clinical symptoms ( abdominal distension , belching , nausea-vomiting , upper-abdominal distending pain , sour regurgitation and gastric burning sensation ) was used to evaluate the therapeutic effect .


There were no statistical differences between two groups in clinical symptom scores before the treatment ( P > 0.05 ) .


Following treatment , the clinical symptom scores of both groups were significantly decreased in comparison with pre-treatment ( P < 0.05 ) and the scores of the acupoint injection group were significantly lower than those of the control group ( P < 0.05 ) .


Of the 23 PGS patients in the control group and acupoint injection group , 0 and 2 were cured , 5 and 10 were significantly improved , 10 and 9 were improved , 8 and 2 failed , with the effective rates being 65.22 % and 91.30 % , respectively .


Acupoint injection of Metoclopramide is effective for improving clinical symptoms of PGS patients .


To examine the association between brain structural changes and - amyloid deposition , and incident dementia in 183 elderly subjects without dementia ( mean age 85.5 years ) 2 years later .


Subjects had a brain structural MRI scan and a PET scan with ( 11 ) C-labeled Pittsburgh compound B ( PiB ) in 2009 , and were evaluated clinically in 2011 .


At baseline evaluation , of the 183 participants ( 146 cognitively normal [ CN ] ) ; 37 mild cognitive impairment [ MCI ] ) , 139 ( 76 % ) were PiB + , had small hippocampal volume ( < 25th percentile ) , or had high white matter lesion ( WML ) volume ( > 75th percentile ) .


Two years later , 111 ( 61 % ) were classified as CN , 51 ( 28 % ) as MCI , and 21 ( 11 % ) as dementia .


At baseline , 51 % of the CN participants and 67.5 % of the MCI cases were PiB + .


Thirty percent of the CN and 51 % of the MCI cases had small hippocampi , and 24 % of the CN and 40.5 % of the MCI cases had abnormal WMLs .


Of the 21 participants who progressed to dementia , 20 ( 95 % ) had at least one imaging abnormality .


Only 3 ( 14 % ) were only PiB + , 1 ( 5 % ) had only small hippocampi , 1 ( 5 % ) had only WMLs , 1 ( 5 % ) was biomarker negative , and the other 16 had various pairs of imaging abnormalities .


Continuous variables of PiB retention , left and right hippocampal volume , and WML volume were independent predictors of dementia in a logistic regression analysis controlling for age , sex , education level , and Mini-Mental State Examination scores .


The prevalence of - amyloid deposition , neurodegeneration ( i.e. , hippocampal atrophy ) , and small vessel disease ( WMLs ) is high in CN older individuals and in MCI .


A combination of 2 or 3 of these factors is a powerful predictor of short-term incidence of dementia .


Molecular characteristics of cancer vary between individuals .


In future , most trials will require assessment of biomarkers to allocate patients into enriched populations in which targeted therapies are more likely to be effective .


The MRC FOCUS3 trial is a feasibility study to assess key elements in the planning of such studies .


Patients with advanced colorectal cancer were registered from 24 centres between February 2010 and April 2011 .


With their consent , patients ' tumour samples were analysed for KRAS/BRAF oncogene mutation status and topoisomerase 1 ( topo-1 ) immunohistochemistry .


Patients were then classified into one of four molecular strata ; within each strata patients were randomised to one of two hypothesis-driven experimental therapies or a common control arm ( FOLFIRI chemotherapy ) .


A 4-stage suite of patient information sheets ( PISs ) was developed to avoid patient overload .


A total of 332 patients were registered , 244 randomised .


Among randomised patients , biomarker results were provided within 10 working days ( w.d. ) in 71 % , 15w .


d. in 91 % and 20w .


d. in 99 % .


DNA mutation analysis was 100 % concordant between two laboratories .


Over 90 % of participants reported excellent understanding of all aspects of the trial .


In this randomised phase II setting , omission of irinotecan in the low topo-1 group was associated with increased response rate and addition of cetuximab in the KRAS , BRAF wild-type cohort was associated with longer progression-free survival .


Patient samples can be collected and analysed within workable time frames and with reproducible mutation results .


Complex multi-arm designs are acceptable to patients with good PIS .


Randomisation within each cohort provides outcome data that can inform clinical practice .


To compare the efficacies of internal fixation by elastic intramedullary nail versus conventional plate osteosynthesis in the treatment of both radius and ulna fractures in children .


A total of 84 cases were randomly divided into control and experimental groups at our department from July 2007 to 2013 .


The control group underwent conventional plating while the experimental group received elastic intramedullary nail .


Preoperative preparations and postoperative rehabilitation protocols were similar .


The operative outcomes were evaluated from pain score at Day 3 post-operation , radiology and forearm curative function , local wound healing after 2 , 4 , 8 weeks , 3 , 6 months and 1 year .


Local wound healing time , radiology and forearm curative function had statistical significance between two groups ( P < 0.05 ) .


And the pain score had significant difference ( P < 0.01 ) .


Elastic intramedullary nail has multiple advantages of mini-invasiveness , quicker healing and excellent function recovery in the treatment of both ulna and radius fractures in children .


As the second commonest cause of death and a major cause of disability worldwide , stroke has greatly influenced patients ' quality of life and created a huge public health burden .


As a special form of physical activity that has been widely practiced in China , and even throughout the world , Tai Chi may be favorable for the rehabilitation of stroke patients .


Several studies have been conducted to investigate the rehabilitative effects of Tai Chi for stroke patients , but none of them have been focused on the recovery phase ( 2 to 24 weeks ) of stroke .


This study is an assessor-blinded randomized controlled trial .


A total of 50 eligible participants will be randomly assigned to either a control group or a Tai Chi group .


Patients in the control group will receive standard , conventional rehabilitation therapies , and a combination of Tai Chi and conventional rehabilitation programs will be applied in the Tai Chi group .


The recovery of motor impairment , functional activity and balance abilities as measured with the Fugl-Meyer Assessment , Barthel Index and Berg Balance Scale will be assessed as primary outcome measures .


The secondary outcome measures to be used are the scores on the Stroke-Specific Quality of Life Scale , the National Institutes of Health Stroke Scale and the objective parameters of the RSscan footscan gait system .


All assessments will be conducted at baseline , 4 weeks after the rehabilitation course and at the end of 3-month follow-up .


The results of this study will provide preliminary evidence regarding the efficacy and feasibility of Tai Chi as an additional rehabilitative program for stroke patients in the recovery phase .


Chinese Clinical Trial Register ID : ChiCTR-TRC-13003661 ( 7 October 2013 ) .


Omega-3 polyunsaturated fatty acid ( PUFA ) may benefit humans and animals with chronic inflammatory diseases .


Omega-3 PUFA supplementation improves clinical signs , lung function , and airway inflammation in horses with recurrent airway obstruction ( RAO ) and inflammatory airway disease ( IAD ) .


Eight research horses and 35 client-owned horses .


A pilot study examined the dose of PUFA that can alter plasma PUFA composition .


Then , a randomized , controlled clinical trial was performed in horses with RAO and IAD .


Horses were fed a complete pelleted diet with no hay and randomly assigned to 1 of 3 daily treatments for 2 months : 30 or 60 g of the supplement or 30 g of placebo .


Clinical signs , lung function , plasma PUFA composition , and bronchoalveolar lavage fluid ( BALF ) cytology were evaluated .


Data were expressed as median ( 25-75th percentiles ) .


P < .05 was considered significant .


Polyunsaturated fatty acid supplementation resulted in increased plasma docosahexaenoic acid ( DHA ) that peaked at 4 weeks .


Clinical improvement was noted in all horses involved in the clinical trial , but the group that received PUFA had greater improvement in clinical signs ( cough score improved 60 % ) , lung function ( respiratory effort decreased 48 % ) , and BALF ( neutrophils decreased from 23 to 9 % ) when compared to placebo ( cough score improved 33 % , respiratory effort decreased 27 % , BALF neutrophils increased from 11 to 17 % ; P < .05 ) .


Feeding horses with RAO and IAD a PUFA supplement containing 1.5-3 g DHA for 2 months provides an additional benefit to low-dust diet .


Patients with severe left ventricular dysfunction , ischemic heart failure , and coronary artery disease suitable for coronary artery bypass grafting ( CABG ) are at higher risk for surgical morbidity and mortality .


Paradoxically , those patients with the most severe coronary artery disease and ventricular dysfunction who derive the greatest clinical benefit from CABG are also at the greatest operative risk , which makes decision making regarding whether to proceed to surgery difficult in such patients .


To better inform such decision making , we analyzed the Surgical Treatment for Ischemic Heart Failure ( STICH ) CABG population for detailed information on perioperative risk and outcomes .


In both STICH trials ( hypotheses ) , 2136 patients with a left ventricular ejection fraction of 35 % and coronary artery disease were allocated to medical therapy , CABG plus medical therapy , or CABG with surgical ventricular reconstruction .


Relationships of baseline characteristics and operative conduct with morbidity and mortality at 30 days were evaluated .


There were a total of 1460 patients randomized to and receiving surgery , and 346 ( 25 % ) of these high-risk patients developed a severe complication within 30 days .


Worsening renal insufficiency , cardiac arrest with cardiopulmonary resuscitation , and ventricular arrhythmias were the most frequent complications and those most commonly associated with death .


Mortality at 30 days was 5.1 % and was generally preceded by a serious complication ( 65 of 74 deaths ) .


Left ventricular size , renal dysfunction , advanced age , and atrial fibrillation/flutter were significant preoperative predictors of mortality within 30 days .


Cardiopulmonary bypass time was the only independent surgical variable predictive of 30-day mortality .


CABG can be performed with relatively low 30-day mortality in patients with left ventricular dysfunction .


Serious postoperative complications occurred in nearly 1 in 4 patients and were associated with mortality .


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


Unique identifier : NCT00023595 .


We explored sex differences in the neural mechanisms mediating placebo analgesia in an established visceral pain model involving painful rectal distensions in healthy volunteers .


N = 15 men and N = 15 women underwent three consecutive functional magnetic resonance imaging sessions during which cued painful rectal distensions were delivered .


After an adaptation session , positive expectations were induced with deceptive instructions regarding administration of an analgesic drug ( placebo session ) .


In the other session ( control ) , truthful information about an inert substance was given .


Sex differences in placebo-induced modulation of neural activation during anticipation and pain were analyzed along with ratings of expected and perceived pain intensity .


Placebo-induced reductions in pain ratings were comparable between men and women .


At the level of the brain , group comparisons with respect to differences between the placebo and control conditions revealed greater modulation of the posterior insula ( regions-of-interest analysis : pFWE < 0.05 ) and dorsolateral prefrontal cortex ( whole-brain analysis : p < 0.001 , uncorrected ) during pain anticipation in women .


During pain , placebo-induced down-regulation of the insula was altered in women compared to men ( ROI analysis : pFWE < 0.05 ) .


Our data provide first evidence supporting sex differences in pain-induced neural modulation during visceral placebo analgesia despite similar placebo-induced reductions in perceived pain intensity .


These preliminary findings might contribute to elucidating mechanisms mediating placebo effects in clinical conditions associated with chronic abdominal pain such as in irritable bowel syndrome .


Task-specific locomotor training has been promoted to improve walking-related outcome after incomplete spinal cord injury ( iSCI ) .


However , there is also evidence that lower extremity strength training might lead to such improvements .


The aim of this randomized cross-over pilot study was to compare changes in a broad spectrum of walking-related outcome measures and pain between robot-assisted gait training ( RAGT ) and strength training in patients with chronic iSCI , who depended on walking assistance .


We hypothesized that task-specific locomotor training would result in better improvements compared to strength training .


Nine participants with a chronic iSCI were randomized to group 1 or 2 .


Group 1 received 16 sessions of RAGT ( 45min each ) within 4 weeks followed by 16 sessions of strength training ( 45min each ) within 4 weeks .


Group 2 received the same interventions in reversed order .


Main outcome measures were the 10m Walk Test ( 10MWT ) at preferred and maximal speed .


Furthermore , we assessed several measures such as walking speed under different conditions , balance , strength , and 2 questionnaires that evaluate risk of falling and pain .


Data were collected at baseline , between interventions after 4 weeks , directly after the interventions and at follow-up 6 months after the interventions .


Pain was assessed repeatedly throughout the study .


There were no significant differences in changes in scores between the 2 interventions , except for maximal walking speed ( 10MWT ) , which improved significantly more after strength training than after RAGT .


Pain reduced after both interventions .


In patients with chronic iSCI dependent on walking assistance , RAGT was not more effective in improving walking-related outcome compared to lower extremity strength training .


However , the low sample size limits generalizability and precision of data interpretation .


This study was registered at Clinicaltrials.gov ( NCT01087918 ) .


Dental caries is the most prevalent communicable disease in the world amongst the population of the children .


To compare the outcome of restorations in primary molars using two Glass ionomer cements Ketac-Molar , a Glass ionomer cement ( GIC ) and Vitremer , a Resin modified glass ionomer cement ( RMGIC ) in small and medium sized cavities .


A randomized controlled trial was conducted on 27 children between ages 4-9 years who had bilateral matched pair of carious lesions in primary posterior teeth .


A split mouth design was used in which two materials , Ketac Molar and Vitremer , were placed on contralateral sides of the oral cavity in the same patient .


The aim was to compare clinical performance of these restorations after 6 months using United States Public Health Service ( USPHS ) criteria .


Data were collected six months after restoration using USPHS criteria .


Statistical analysis was conducted using SPSS-16 .


Categorical variables were described as frequencies , and percentages .


Chi-square test was used to compare the frequencies between groups keeping statistical significance at p < 0.05 .


Based on the USPHS criteria , after six months the results of Ketac Molar and Vitemer were comparable , except for sensitivity where RMGIC performed significantly better ( p = 0.040 ) .


Though not significantly different , GIC performed better in 2/10 variables namely marginal discoloration and surface staining .


RMGIC did better in 4/10 variables namely marginal integrity , retention , secondary caries and sensitivity .


Both cements performed almost equally well in 4/10 variables , i.e. , colour match , anatomic form , surface texture and proximal contact .


Overall the clinical performance of Vitremer was better than Ketac molar and is to be considered as a preferable material for restoration of primary molars .


More studies are recommended to confirm the results of the present study .


To compare the incidence rates of postoperative urinary incontinence between transurethral bipolar plasmakinetic enucleation and resection of the prostate ( PKERP ) and transurethral bipolar plasmakinetic resection of the prostate ( PKRP ) , and provide evidence for the clinical application of PKERP .


Totally , 180 BPH patients were equally and randomly assigned to undergo PKERP and PKRP , respectively .


We measured the urinary incontinence of the patients by pad test at 24 hours after extubation and every week after surgery for 4 weeks .


Meanwhile , we recorded and compared the PSA level , prostate volume , Qmax , residual urine , IPSS , QOL , and the results of pad test between the two groups before and after surgery .


The incidence rates of urinary incontinence in the PKERP and PKRP groups were 35.56 % and 18.89 % ( P < 0.01 ) at 24 hours after extubation , 20.00 % and 7.78 % at 1 week after surgery ( P < 0.05 ) , and 3.33 % and 2.22 % at 2 weeks .


There was no significant difference in the severity of urinary incontinence between the two groups at any time point ( P > 0.05 ) .


No permanent urinary incontinence was observed in either group .


Compared with PKRP , PKERP has a higher incidence rate of short-term urinary incontinence in the treatment of BPH , but not that of genuine incontinence , with similar severity and recovery time .


To investigate the relationship between Vitamin D deficiency and acute otitis media infection .


The randomised , single-blind , case-control study was conducted at the Paediatric Department of Ataturk University , Erzurum , Turkey , from January to April 2010 .


It comprised ambulatory children diagnosed with acute otitis media and healthy controls .


The subjects were divided into groups according to their serum 25-hydroxy vitamin D levels .


SPSS 18 was used for statistical analysis .


Of the 169 subjects in the study , 88 ( 52 % ) were the cases and 81 ( 48 % ) were controls .


The mean age of the cases was 6.213.4 years , and 6.183.12 years for the controls ( p < 0.951 ) .


Serum 25-hydroxy vitamin D levels in the cases and controls were 20.610.2 ng/mL and 23.810.3 ng/mL ( p < 0.05 ) .


There was no statistically significant difference between the groups in terms of parathormone and calcium levels ( p > 0.05 ) .


Serum 25-hydroxy vitamin D levels being significantly lower in children diagnosed with acute otitis media compared to the controls in two otherwise similar groups suggests that Vitamin D deficiency plays a role in otitis media infection .


Chronic kidney disease ( CKD ) is strongly related to outcome in cardiovascular diseases .


The relationship between treatment of mitral regurgitation ( MR ) and renal function is not well described .


We sought to evaluate renal function before and after mitral valve repair by the MitraClip device .


Patients with moderate-to-severe or severe ( 3 + or 4 + , respectively ) MR by core laboratory determination who underwent transcatheter mitral valve repair with the MitraClip device in multicenter , investigational trials were included in this study .


Estimated glomerular filtration rate ( eGFR ) was evaluated before and at hospital discharge , 30 days , 6 months , and 1 year after mitral valve repair .


Eight hundred fifty-four patients with baseline mean eGFR 61.5 23.1 mL/min/1 .73 m ( 2 ) were studied , including 438 ( 51.3 % ) with eGFR 60 mL/min/1 .73 m ( 2 ) ( CKD stage 1 or 2 ) , 371 ( 42.6 % ) with eGFR 30 to 59 mL/min/1 .73 m ( 2 ) ( CKD stage 3 ) , and 52 ( 6.1 % ) with eGFR < 30 mL/min/1 .73 m ( 2 ) ( CKD stage 4 or 5 ) .


Baseline renal dysfunction was more prevalent in older patients with a history of heart failure , coronary artery disease , cerebrovascular disease , diabetes mellitus , hypertension , and atrial fibrillation .


Baseline eGFR was associated with 1-year survival ( P < 0.001 ) after MitraClip repair .


At 1-year follow-up , the mean change in eGFR for the overall cohort was -1.0 15.1 mL/min/1 .73 m ( 2 ) ; for patients with CKD stage 1 or 2 , stage 3 , or stage 4 or 5 , mean change was -4.1 16.6 , +2.6 12.4 , and +4.8 9.5 mL/min/1 .73 m ( 2 ) , respectively .


Linear mixed effect modeling demonstrated a strong association between MR and eGFR , and a statistically significant improvement in eGFR in patients with CKD stage 4 or 5 associated with MR reduction to 2 + ( P = 0.007 ) .


Renal dysfunction is associated with lower survival in patients with severe MR even after percutaneous mitral valve repair .


Reduction in MR severity by the MitraClip device is associated with improvement in renal function at 1 year in patients with baseline renal dysfunction .


http://www.clinicaltrials.gov .


Unique identifiers : NCT00209274 , NCT01931956 , NCT01940120 .


Bipolar Disorder ( BD ) is a severe mental health problem .


Psychological interventions are recommended by the National Institute for Health and Care Excellence ( NICE ) but patients experience severe inequalities in access .


This study assessed the feasibility and potential effectiveness of a recovery informed web-based self-management intervention for people with BD .


An online randomised controlled trial ( n = 122 ) compared treatment as usual ( TAU ) plus the ` Living with Bipolar ' ( LWB ) intervention with a waiting list control ( WLC ) group .


The study recruited to target and the retention rates were high .


Participants engaged with the approach .


Compared with the WLC , those receiving LWB showed the most robust improvement in psychological and physical domains of quality of life , wellbeing and recovery at the end of the intervention .


The trial was not definitive and requires further investigation .


There is preliminary evidence that a web-based treatment approach in BD is feasible and potentially effective .


Such interventions could form part of the Improving Access to Psychological Therapy ( IAPT ) initiative in severe mental health .


Trauma exposure predicts mental disorders , medical morbidity , and health care costs .


Yet trauma-related impacts have not received sufficient attention in primary care provider ( PCP ) training programs .


This study adapted a theory-based approach to working with trauma survivors , Risking Connection , into a 6-hour CME course , Trauma-Informed Medical Care ( TI-Med ) , and evaluated its efficacy .


We randomized PCPs to training or wait-list ( delay ) conditions ; wait-list groups were trained after reassessment .


The primary outcome assessing newly acquired skills was a patient-centeredness score derived from Roter Interactional Analysis System ratings of 90 taped visits between PCPs and standardized patients ( SPs ) .


PCPs were family medicine residents ( n = 17 ) and community physicians ( n = 13 , 83 % family medicine specialty ) , from four sites in the Washington , DC metropolitan area .


Immediately trained PCPs trended toward a larger increase in patient centeredness than did the delayed PCPs , with a moderate effect size ( .66 ) .


The combined trained PCP groups showed a significant increase in patient centeredness from before to after training .


This is a promising approach to supporting relationship-based trauma-informed care among PCPs to help promote better patient health and higher compliance with medical treatment plans .


In this study , we compared the effectiveness of laser-aided circumferential supracrestal fiberotomy ( CSF ) and low-level laser therapy ( LLLT ) with conventional CSF in reducing relapse of corrected rotations .


The study included 24 patients who were at the finishing stage of orthodontic treatment and had at least 1 maxillary incisor with 30 to 70 of rotation before starting therapy .


The subjects were divided into 4 groups by treatment : conventional CSF , Er : YAG laser-aided CSF , LLLT , and control .


After alginate impressions were taken , the archwire was sectioned from the experimental incisors , and they were allowed to relapse .


The second impression was taken 1month later , and the degree and percentage of relapse were calculated in photographs taken from the dental models .


Gingival recession , pocket depth , and pain were also measured in the CSF groups .


The mean percentages of relapse were 9.7 % in the conventional CSF , 12.7 % in the Er : YAG laser-aided CSF , 11.7 % in the LLLT , and 27.8 % in the control groups .


Relapse was significantly greater in the control than the experimental groups ( P < 0.05 ) , which were not statistically different from each other .


The changes in sulcus depth and gingival recession were small and not significantly different among the CSF groups ( P > 0.05 ) , but pain intensity was greater in subjects who underwent conventional CSF ( P = 0.003 ) .


Er : YAG laser-aided CSF proved to be an effective alternative to conventional CSF in reducing rotational relapse .


LLLT with excessively high energy density was also as effective as the CSF procedures in alleviating relapse , at least in the short term .


The aim of this study was to investigate the difference in subjective cure rate and patient satisfaction between tension-free vaginal tape ( TVT ) and transobturator tape ( TOT ) surgical methods in the treatment of stress and mixed urinary incontinence .


From January 2004 to November 2006 , a total of 100 patients suffering from stress or mixed urinary incontinence and evaluated to benefit from operative treatment were randomized to undergo either TVT or TOT surgery in Oulu University Hospital .


There were no significant differences between the study groups concerning the patient characteristics .


During the 3 , 14 and 46 month follow-up steps , information on subjective cure and patient satisfaction was gathered with Urinary Incontinence Severity Score and Detrusor Instability Score questionnaires and a specific question about satisfaction .


The subjective cure rate was 81 % in both study groups .


The satisfaction rate was 79 % in the TVT group and 74 % in the TOT group at the final follow-up .


Urge symptoms were relieved in 70 % of patients in the mixed urinary incontinence subgroup .


De novo urgency occurred in 17 % of the patients in the stress urinary incontinence subgroup , and 45 % of these patients were unsatisfied after the follow-up .


TVT and TOT are equally effective methods in the treatment of urinary incontinence and patient satisfaction is similar in both methods .


A large proportion of patients with mixed urinary incontinence found the operation beneficial for urge symptoms .


A single nucleotide polymorphism ( SNP ) of the patatin-like phospholipase-3 ( PNPLA3 ) / adiponutrin gene ( rs738409 C > G ) is strongly associated with nonalcoholic fatty liver disease ; to our knowledge , no data are available on the impact of this PNPLA3 SNP on liver and metabolic outcomes during pregnancy in patients with gestational diabetes ( GD ) .


We evaluated the impact of the PNPLA3 rs738409 SNP on liver enzymes , metabolic indexes , and maternal and neonatal outcomes in 200 GD patients enrolled in a lifestyle intervention .


In a randomized trial with a 2 2 factorial design , exercise significantly improved maternal and neonatal outcomes in GD patients .


Effects of the G allele on metabolic and liver indexes and maternal and neonatal outcomes were evaluated in these patients .


At the end of the trial , fasting insulin and homeostasis model assessment of insulin resistance ( HOMA-IR ) values were significantly lower and liver enzymes significantly higher in PNPLA3 G-allele carriers .


In a multiple regression model , the G allele was associated directly with aspartate aminotransferase ( = 2.60 ; 95 % CI : 0.99 , 4.20 ) , alanine aminotransferase ( = 3.70 ; 95 % CI : 1.78 , 5.62 ) , and - glutamyl transferase ( = 3.70 ; 95 % CI : 0.80 , 6.60 ) and inversely with insulin ( = -2.01 ; 95 % CI : -3.24 , -0.78 ) and HOMA-IR ( = -0.39 ; -0.64 , -0.14 ) values at the end of the trial .


In a multiple logistic regression model , the G allele was associated directly with risk of developing liver enzyme elevation during pregnancy ( OR : 4.21 ; 95 % CI : 1.78 , 9.97 ) and inversely with the birth of large-for-gestational-age newborns ( OR : 0.19 ; 95 % CI : 0.06 , 0.62 ) .


No diet genotype or exercise genotype interaction was shown .


The PNPLA3 SNP rs738409 G allele was associated with risk of mildly elevated transaminases in GD independent of a lifestyle intervention and despite a significant reduction in insulin resistance and risk of macrosomic offspring .


This trial was registered at clinicaltrials.gov as NCT01506310 .


Day-hospital-based treatment programmes have been recommended for poorly functioning patients with personality disorders ( PD ) .


However , more research is needed to confirm the cost-effectiveness of such extensive programmes over other , presumably simpler , treatment formats .


This study compared health service costs and psychosocial functioning for PD patients randomly allocated to either a day-hospital-based treatment programme combining individual and group psychotherapy in a step-down format , or outpatient individual psychotherapy at a specialist practice .


It included 107 PD patients , 46 % of whom had borderline PD , and 40 % of whom had avoidant PD .


Costs included the two treatment conditions and additional primary and secondary in - and outpatient services .


Psychosocial functioning was assessed using measures of global ( observer-rated GAF ) and occupational ( self-report ) functioning .


Repeated assessments over three years were analysed using mixed models .


The costs of step-down treatment were higher than those of outpatient treatment , but these high costs were compensated by considerably lower costs of other health services .


However , costs and clinical gains depended on the type of PD .


For borderline PD patients , cost-effectiveness did not differ by treatment condition .


Health service costs declined during the trial , and functioning improved to mild impairment levels ( GAF > 60 ) .


For avoidant PD patients , considerable adjuvant health services expanded the outpatient format .


Clinical improvements were nevertheless superior to the step-down condition .


Our results indicate that decisions on treatment format should differentiate between PD types .


For borderline PD patients , the costs and gains of step-down and outpatient treatment conditions did not differ .


For avoidant PD patients , the outpatient format was a better alternative , leaning , however , on costly additional health services in the early phase of treatment .


Clinical Trials NCT00378248 .


Induction of therapeutic hypothermia is often complicated by shivering .


Nefopam , a nonsedative benzoxazocine analgesic , reduces the shivering threshold ( triggering core temperature ) with minimal side effects .


Consequently , nefopam is an attractive drug for inducing therapeutic hypothermia .


However , nefopam alone is insufficient and thus needs to be combined with another drug .


Meperidine also reduces the shivering threshold .


We therefore determined whether the combination of nefopam and meperidine is additive , infra-additive , or synergistic on the shivering threshold .


Ten volunteers were each studied on 4 randomly assigned days .


In random order , they were given the following treatments : ( 1 ) control , no drug ; ( 2 ) nefopam to a target concentration of 0.1 g/mL ; ( 3 ) meperidine to a target concentration of 0.1 g/mL ; and ( 4 ) both nefopam and meperidine at target concentrations of 0.1 g/mL each .


Lactated Ringer 's solution at 4C was infused to decrease core temperature while mean skin temperature was kept near 30.5 C.


The core temperature that increased oxygen consumption > 25 % defined the shivering threshold .


Nefopam reduced the shivering thresholds by 0.7 C 0.3 C compared with no drug .


Meperidine reduced the shivering thresholds by 0.4 C 0.3 C compared with no drug .


When combined , the shivering threshold decreased by only 0.6 C 0.4 C , which was about half what would have been expected based on the individual effects of each drug ( P < 0.001 ) .


The effect of combined nefopam and meperidine on the shivering threshold was thus infra-additive .


The combination of nefopam and meperidine should be avoided for induction of therapeutic hypothermia .


Better options would be combinations of drugs that are at least additive or even synergistic .


Research on face-to-face treatment for substance misuse suggests that patients ' social networks may impact treatment entry and participation , but there has been no similar research on entry and participation in telephone-based continuing care .


We examined whether alcohol-specific social support predicted engagement and participation in telephone continuing care for alcohol dependence , and whether treatment participation resulted in beneficial changes in participants ' social networks .


Participants were 252 adults ( 162 male ) enrolled in a randomized clinical trial testing the effectiveness of telephone continuing care for alcohol dependence .


Participants who completed 3 weeks of intensive outpatient treatment were randomly assigned to treatment as usual , telephone monitoring ( TM ; N = 83 ) , or telephone monitoring and brief counseling ( TMC ; N = 83 ) .


TM and TMC included 18 months of telephone treatment .


Alcohol-specific social support was measured with the Important People Inventory at baseline and 6 , 12 , 18 , and 24-month follow-up .


Alcohol-specific social support did not predict entry into TM or TMC .


Among those who entered telephone treatment ( N = 127 ) , participants with higher network percentage of daily drinkers , higher percentage of network members who accept drinking , and lower percentage of network members who do not accept drinking completed more continuing care calls .


There was no effect of continuing care participation on alcohol-specific social support over 24 months of follow-up .


Participants with more problematic social networks may self-select additional support in the form of telephone continuing care .


Telephone continuing care does not appear to result in social network change .


A serogroup B meningococcal vaccine ( 4CMenB ) has been licensed by the European commission for use in various infant schedules .


However , data are limited on persistence of serum bactericidal antibodies ( SBA ) , which is necessary to inform cost-effectiveness analysis .


Sera were obtained from 3 groups of 5-year-old children previously immunized at 6 , 8 , 12 and 40 months with either 4CMenB or rMenB ( which lacks the outer membrane vesicle of 4CMenB ) or at 40 and 42 months with 4CMenB only .


Forty-nine control children were also recruited and blood obtained before and after 2 doses of 4CMenB at 60 and 62 months of age .


Sera were tested for SBA to meningococcal B reference strains .


At 5 years of age , 67 % of those receiving 4CMenB in infancy had SBA titers 1:4 for strain 44/76 , 100 % for 5/99 , 17 % for NZ98/254 and 45 % for M10713 .


Results for rMenB recipients varied from 0 ( NZ98/254 ) to 100 % ( 5/99 ) .


Of those immunized with 4CMenB at 40 and 42 months , 38 % had SBA titers 1:4 at age 5 for 44/76 , 100 % for 5/99 , 0 % ( NZ98/254 ) and 83 % ( M10713 ) .


Among controls , SBA titers were 1:4 in 4 % ( H44/76 , 5/99 ) , 0 % ( NZ98/254 ) and 67 % ( M10713 ) at baseline , increasing to 100 % ( H44/76 and 5/99 ) , 89 % ( NZ98/254 ) and 97 % ( M10713 ) postimmunization .


The variable rates of waning of antibody to the 4 components of 4CMenB complicates estimates of duration of protection and should be taken into account in cost-effectiveness analyses .


A 2-dose schedule of 4CMenB in 5-year-old children was immunogenic .


To compare the postoperative analgesic efficacy and side effects of paracetamol and tramadol in patients undergoing lumbar disc surgery .


Group P ( paracetamol group ) was given 1 g of paracetamol intravenously 30 min before the end of the operation and 1 g each day at 6-h intervals .


Group T ( tramadol group ) was given 1.5 mg/kg of tramadol as a loading dose and patient-controlled analgesia for 1 day .


Hemodynamic parameters , modified Aldrete score , Ramsay sedation scale score , patient satisfaction scale ( PSS ) score , visual analog scale ( VAS ) score , nausea/vomiting scale score , and additional analgesic needs/times were recorded .


PSS scores were significantly higher in Group T ( P < 0.05 ) .


The total analgesic consumption was significantly higher in Group P.


There were no significant differences in the VAS scores at any time points .


Twenty-one patients in Group P and 8 patients in Group T needed additional analgesia ( P < 0.05 ) .


The first additional analgesic time was earlier in Group P , and pain was more evident at the 15th minute and at hours 2 and 6 ( P < 0.05 ) .


Paracetamol alone was not able to provide effective analgesia .


Tramadol was more effective in the treatment of postoperative pain after lumbar disc surgery .


Unintended pregnancy remains a serious public health challenge in the USA .


We assessed the effects of an intervention to increase patients ' access to long-acting reversible contraceptives ( LARCs ) on pregnancy rates .


We did a cluster randomised trial in 40 reproductive health clinics across the USA in 2011-13 .20 clinics were randomly assigned to receive evidence-based training on providing counselling and insertion of intrauterine devices ( IUDs ) or progestin implants and 20 to provide standard care .


Usual costs for contraception were maintained at all sites .


We recruited women aged 18-25 years attending family planning or abortion care visits and not desiring pregnancy in the next 12 months .


The primary outcome was selection of an IUD or implant at the clinic visit and secondary outcome was pregnancy within 12 months .


We used generalised estimating equations for clustered data to measure the intervention effect on contraceptive selection , and used survival analysis to assess pregnancy rates .


Of 1500 women enrolled , more at intervention than control sites reported receiving counselling on IUDs or implants ( 565 [ 71 % ] of 797 vs 271 [ 39 % ] of 693 , odds ratio 38 , 95 % CI 28-52 ) and more selected LARCs during the clinic visit ( 224 [ 28 % ] vs 117 [ 17 % ] , 19 , 13-28 ) .


The pregnancy rate was lower in intervention group than in the control group after family planning visits ( 79 vs 154 per 100 person-years ) , but not after abortion visits ( 265 vs 223 per 100 person-years ) .


We found a significant intervention effect on pregnancy rates in women attending family planning visits ( hazard ratio 054 , 95 % CI 034-085 ) .


The pregnancy rate can be reduced by provision of counselling on long-term reversible contraception and access to devices during family planning counselling visits .


William and Flora Hewlett Foundation .


The anti-IgE monoclonal antibody , omalizumab , is approved in the US as add-on therapy for patients 12 years of age with moderate-to-severe persistent allergic asthma .


Omalizumab is administered according to the US Food and Drug Administration approved dosing table included in the prescribing information .


The dosing table was developed using Genentech 's free IgE assay and is designed to achieve free serum IgE levels of < 50ng/mL , known to be associated with clinical benefit .


Lack of clinical benefit in a subset of patients on omalizumab has prompted demand for commercial free IgE assays to guide omalizumab dosing .


To date , two commercial free IgE assays marketed by ViraCor-IBT ( no longer offered ) and BioTeZ have been available to physicians .


This study compares the results generated from the two commercial free IgE assays with the free IgE levels generated by the Genentech assay .


Two serum sample sets were prepared using 20 samples from patients with a wide range of IgE and omalizumab from an omalizumab clinical trial and 36 samples from omalizumab-nave patients .


Different amounts of omalizumab were added to the 36 omalizumab nave samples based on measured total IgE levels to ensure that a good range of IgE and omalizumab was represented in the study samples .


Samples were randomized for blinded analysis of free IgE levels using the Genentech , ViraCor-IBT and BioTeZ free serum IgE assays .


Analysis of samples in the ViraCor-IBT assay were conducted by ViraCor-IBT and the analysis of samples using the Genentech and BioTeZ assay methods were conducted by a third party contract research organization .


The ViraCor-IBT and BioTeZ free IgE assays demonstrated significantly higher free IgE levels than the Genentech free IgE assay .


Twenty-nine of 56 samples tested < 50ng/mL in the Genentech assay ; of these , 12/29 ( 41 % ) and 20/29 ( 69 % ) tested > 50ng/mL in the BioTeZ and ViraCor-IBT assays , respectively .


In the BioTeZ free IgE evaluations , 11/20 samples that were re-tested had inter-assay differences ranging from 40-190 % .


Free ligand ( such as IgE ) measurements are challenging and dependent on the method and reagents used .


The Viracor-IBT and BioTeZ methods tend to over-estimate free serum IgE levels compared with the Genentech free IgE assay .


Using these assays to monitor therapy and adjust omalizumab doses post treatment is considered off-label use and could lead to a potential risk for unnecessary treatment and/or risk to patient safety .


Acute liver failure ( ALF ) usually develops in multiple organ dysfunction syndrome ( MODS ) and carries a high mortality risk in patients after cardiac surgery .


Artificial liver support devices aim to remove albumin-bound and water-soluble toxins arising as a result of liver failure .


The currently most used devices combine haemodialysis with albumin dialysis ( MARS ) or plasma separation and adsorption ( Prometheus ) .


The aim of this study was to assess safety and efficacy of use MARS or Prometheus in elderly patients with ALF have been operated for heart diseases .


We studied 26 elder patients with ALF and MODS as postoperative complication after cardiac surgery .