Intervention participants received tailored advice three times within 4 months .


Long-term effects ( 12 months after the intervention has started , i.e. 8 months after the intervention was completed ) on PA ( i.e. self-reported weekly minutes and days of sufficient PA ) were tested using multilevel linear regression analyses .


Participants ' age , gender , BMI , educational level , PA intention and the presence of a chronic physical limitation were considered to be potential moderators of the effect .


Overall , the Active Plus intervention was effective in increasing weekly days of sufficient PA ( B = 0.49 ; p = .005 ) , but ineffective in increasing weekly minutes of PA ( B = 84.59 ; p = .071 ) .


Per intervention condition analysis showed that the PB-intervention ( B ( days ) = 0.64 ; p = .002 ; B ( min ) = 111.36 ; p = .017 ) and the PE-intervention ( B ( days ) = 0.70 ; p = .001 ; B ( min ) = 157.41 ; p = .001 ) were effective in increasing days and minutes of PA. .


Neither Web-based conditions significantly increased PA , while the control group decreased their PA. .


In contrast to the intervention effect on minutes of PA , the effect on weekly days of PA was significantly moderated by the participants ' baseline intention to be sufficiently physically active .


In general , after 12 months the print-delivered interventions resulted in stronger effects than the Web-based interventions .


The participants ' baseline intention was the only significant moderator of the intervention effect .


All other assessed user characteristics did not significantly moderate the effect of the intervention , which might indicate that the intervention is sufficiently tailored to the different participant characteristics .


Additional efforts should be taken to increase the sustainability of Web-based interventions .


Dutch Trial Register : NTR2297 .


The aim of this study was to evaluate the efficacy of Mycobacterium w ( Mw ) , an immunomodulator in severe sepsis .


Patients 18 years or older with severe sepsis were randomized within 48 hours of first organ dysfunction to receive either intradermal Mw or saline .


The primary end point was 28-day mortality , whereas the secondary end points were ventilator days , intensive care unit ( ICU ) and hospital length of stay , and delta Sequential Organ Failure Assessment ( SOFA ) score .


Fifty patients with severe sepsis ( 25 Mw , 25 control ) were included in the study .


There were 7 and 8 deaths in the Mw and control groups , respectively ( P = 0.51 ) .


The days on mechanical ventilator were significantly lesser in the Mw group compared with control ( median , 6 vs 9 ; P = 0.025 ) .


The median ICU and hospital length of stay was significantly less in the Mw arm ( 7 vs 12 days [ P = 0.006 ] and 10 vs 16 [ P = 0.007 ] , respectively ) .


The delta SOFA score was significantly higher in the control arm ( P = 0.027 ) .


There was a higher incidence of secondary bacterial infections in the control group ( P = 0.009 ) .


The use of Mw in severe sepsis was associated with significant reduction in days on mechanical ventilation , ICU and hospital length of stay , lower incidence of nosocomial infection , and delta SOFA score .


To investigate the clinical efficacy of noninvasive positive pressure ventilation ( NPPV ) in treatment of patients with arrhythmia complicated by sleep apnea syndrome ( SAS ) .


One hundred and thirty-five arrhythmia patients with polysomnography diagnosed SAS were randomly divided into NPPV group ( 69 cases ) and control group ( 66 cases ) , the NPPV group was treated with standard medications and NPPV , and the control group was treated with standard medications .


SAS related parameters were compared between the groups after 3 months therapy .


( 1 ) Epworth sleepiness scale ( ESS ) score , apnea-hypopnea index ( AHI ) and arousal index were significantly lower ( 8.25 5.41 vs. 4.08 3.43 , 39.95 7.32 vs. 4.71 1.80 and 39.69 4.40 vs. 15.20 2.05 , P < 0.01 ) while not rapid eye movement ( NREM ) III and rapid eye movement stage of sleep time and lowest pulse oxygen saturation ( LSaO2 ) were significantly higher in NPPV group than in control group [ ( 4.53 2.10 ) % vs. ( 16.78 2.59 ) % , ( 8.37 1.380 ) % vs. ( 15.25 1.41 ) % , ( 77.15 6.72 ) % vs. ( 93.35 2.03 ) % , P < 0.01 ] after 3 months therapy .


( 2 ) Incidence of Sinus bradycardia , sinus tachycardia , sinus arrest , atrial premature beats , ventricular premature beats , paroxysmal atrial tachycardia , paroxysmal ventricular tachycardia , atrial fibrillation , II-III degree atrioventricular block , ST-T segment changes were reduced from 57.4 % , 44.4 % , 7.4 % , 20.4 % , 13.0 % , 36.5 % , 12.0 % , 8.3 % , 37.0 % , 53.7 % to 4.6 % , 1.9 % ,0.0 % , 3.7 % , 2.8 % , 7.0 % , 0.9 % , 0.0 % , 1.9 % , 4.6 % ( all P < 0.05 ) and the total number of arrhythmias happened at night were significantly lower ( all P < 0.05 ) while the heart rate variability ( HRV ) were significantly higher ( P < 0.01 ) in NPPV group than in control group ; AHI was positively while LSaO2 was negatively correlated with the total night arrhythmia number ( P < 0.01 ) .


Noninvasive positive pressure ventilation is an effective therapy strategy for treating patients with arrhythmia complicated by sleep apnea syndrome .


Premenstrual dysphoric disorder ( PMDD ) afflicts ~ 7 % of reproductive-age women resulting in impaired relationships , diminished overall quality of life , and disability-adjusted life years lost on par with other major psychiatric disorders .


Response to pharmacological treatment is inadequate in ~ 50 % of women with PMDD .


The goal of the present study is to evaluate the effects of a novel approach-short-term chromium supplementation-on menstrual cycle-related mood and physical symptoms .


Five women were studied under single-blind conditions in a private clinical setting ( 2 of them were referred specifically for treatment-resistant menstrual-related symptoms ) ; 6 women completed a double-blind crossover study of chromium plus placebo versus chromium plus sertraline in a university clinical research setting .


Treatments were administered from mid-cycle to onset of menses in 1-month intervals .


Symptom ratings were obtained by self-report , using daily symptom checklists , and by clinical assessment , using the Hamilton Psychiatric Rating Scale for Depression ( HAM-D ) and the Clinical Global Impressions ( CGI ) scale .


Overall , chromium treatment was associated with reduced mood symptoms and improved overall health satisfaction in most participants .


In some cases , chromium alone was associated with marked clinical improvement ; in others , chromium plus an antidepressant resulted in greater improvement than either chromium alone or an antidepressant alone .


These preliminary observations suggest that chromium may be a useful monotherapy or adjunctive therapy for women suffering from significant menstrual cycle-related symptoms .


Larger , controlled studies are needed to evaluate the efficacy of chromium treatment in this patient population .


Low back pain ( LBP ) is an important health problem in all developed countries and is associated with high levels of disability .


Evidence-based clinical practice guidelines usually recommend different physical therapy interventions to manage this condition .


However , those interventions usually result in small to moderate clinical effects .


Recent studies suggest that interventions based on subgroup classifications may improve the effect sizes compared with rehabilitation programs where the same interventions were applied to all patients .


This study will investigate the efficacy of treatment based on a Movement System Impairment ( MSI ) - based classification model for patients with chronic LBP compared with general exercise .


The primary outcomes will be pain intensity and disability at 2 months after randomization .


The study is a 2-arm , prospectively registered , randomized controlled trial with a blinded assessor .


The study setting will be a university physical therapy clinic in Brazil .


A total of 148 individuals with chronic LBP will participate in the study .


Included individuals will be randomly allocated to participate in an 8-week treatment program based on the MSI-based classification or a general exercise program of stretching and strengthening exercises .


Pain intensity , disability , and global impression of recovery will be assessed by a blinded assessor at baseline and at follow-up appointments after treatment ( 2 months ) and 4 and 6 months after randomization .


Therapists will not be blinded .


The results of this study may contribute to a better understanding of the efficacy of treatments based on classification of participants with chronic LBP into subgroups .


Amino acid infusion is frequently selected to avoid hypothermia during surgery .


However , changes in electrolytic concentration resulting from its use are unclear .


The aim of this study was to identify the effect of amino acid on body temperature and changes in electrolytic concentrations .


Thirty women undergoing breast cancer surgery under general anesthesia were divided into the following three groups : no amino acid administration , low-dose administration ( 2 ml x kg ( -1 ) x hr ( -1 ) ) , and high-dose administration ( 4 ml x kg ( -1 ) x hr ( -1 ) ) .


Esophageal temperature was recorded every ten minutes and arterial blood samples were obtained before and after surgery .


Body temperatures at each time point and arterial blood gas data , including blood gases , electrodes , serum glucose , and hematocrit were compared between the three groups .


Body temperature started to increase significantly 40 minutes after starting general anesthesia in the high-dose group , 90 minutes after starting general anesthesia in the low-dose group compared with the no amino acid group .


Body temperature was maintained until surgery was completed .


The concentration of sodium ion decreased significantly ( 2.4 mmol x l ( -1 ) ) in the high-dose group compared with the other two groups .


The concentration of other electrolytes , including potassium , chloride , and calcium , did not change significantly .


Perioperative amino acid administration was effective in maintaining a stable body temperature during surgery under general anesthesia .


However , sodium ion concentration might decrease after amino acid administration of 4 ml x kg ( -1 ) x hr ( -1 ) or greater .


The aim of this study was to investigate the effect of a 6-wk intervention with either lifestyle intervention ( increased physical activity and a low-calorie diet ) or a meal replacement regimen on glycemic control in patients who are prediabetic and have impaired fasting glucose .


Forty-two overweight or obese men and women ( age 54 8 y ; weight 95.1 11.9 kg ; body mass index [ BMI ] 32.8 2.89 kg/m ( 2 ) ) were included in this randomized controlled clinical trial .


Patients in the lifestyle group ( LS ; n = 14 ) received dietary counseling sessions ( fat-restricted low-calorie diet ) and instructions on how to increase physical activity .


Patients in the meal replacement group ( MR ; n = 28 ) were instructed to replace two daily meals with a low-calorie , high soy-protein drink with a low glycemic index .


Both interventions resulted in a significant decrease in body weight and BMI , although the reduction was more pronounced ( P < 0.05 ) in the MR group .


In both groups , glucose concentrations decreased significantly ( LS : -12 mg/dL , P < 0.01 ; MR : -11 mg/dL , P < 0.01 ) , and mean glucose levels returned to the normal range .


Insulin ( LS : -1 U/mg [ not significant ] ; MR : -6.3 U/mg , P < 0.01 ) and homeostasis model assessment of insulin resistance ( HOMA-IR ; LS -0.92 , P < 0.01 ; MR : -2.1 , P < 0.01 ) were also significantly lower following both interventions ; again improvements were more pronounced in the MR group ( insulin : P < 0.05 ; HOMA P < 0.01 ) CONCLUSION : It can be concluded that meal replacement is an effective intervention for rapid improvement of elevated fasting glucose and increased insulin concentrations , these being important biomarkers of the prediabetic state .


The 6-wk intervention has shown that the effect of meal replacement on fasting blood glucose was comparable to the effect of lifestyle intervention .


The alterations in BMI , insulin , and HOMA-IR were significantly more pronounced following the meal replacement regimen .


Adverse reactions during propofol sedation include a decrease in arterial blood pressure , propofol-induced pain on injection , and airway complications .


The purpose of this study was to investigate whether combined use of intravenous propofol and inhaled nitrous oxide could decrease the hypotensive and other adverse effects of propofol .


We designed and implemented a prospective , randomized controlled trial .


Patients undergoing dental procedures requiring intravenous sedation were randomly allocated to 2 groups : group P comprised those receiving sedation with propofol alone , and group N+P comprised those receiving sedation with 40 % nitrous oxide inhalation and propofol .


During the dental procedures , the sedation level was maintained at an Observer 's Assessment of Alertness/Sedation scale score of 4 by adjusting propofol 's target plasma concentration .


Nitrous oxide inhalation was the predictor variable , whereas the hemodynamic changes , amount and concentration of propofol , and adverse events were the outcome variables .


Eighty-eight patients were successfully analyzed without any complications .


The total amount of propofol was significantly less in group N+P ( 249.8 121.7 mg ) than in group P ( 310.3 122.4 mg ) ( P = .022 ) , and the mean concentration of propofol was significantly less in group N+P ( 1.81 0.34 g/mL ) than in group P ( 2.05 0.44 g/mL ) ( P = .006 ) .


The mean blood pressure reduction in group N+P ( 11.0 8.0 mm Hg ) was significantly smaller than that in group P ( 15.8 10.2 mm Hg ) ( P = .034 ) .


Pain associated with the propofol injection and memory of the procedure were less in group N+P ( P = .011 and P = .048 , respectively ) .


Nitrous oxide did not affect respiratory conditions or recovery characteristics .


The results of this study suggest that nitrous oxide inhalation combined with propofol sedation attenuates the hypotensive effect and pain associated with propofol injections , along with potentiating the amnesic effect .


Recombinant granulocyte colony-stimulating factors ( G-CSFs ) reduce the incidence and duration of chemotherapy-induced neutropenia and febrile neutropenia when given as adjunct therapy to patients receiving myelosuppressive chemotherapy .


Balugrastim is a long-acting G-CSF composed of a genetic fusion between recombinant human serum albumin and G-CSF .


We compared the efficacy and safety of balugrastim and pegfilgrastim , a long-acting pegylated recombinant G-CSF , in patients with breast cancer who were scheduled to receive chemotherapy .


In this double-blind randomized phase III trial , patients with 1.5 10 ( 9 ) neutrophils/L were randomly assigned to subcutaneous injections of balugrastim 40 mg ( n = 153 ) or pegfilgrastim 6 mg ( n = 151 ) .


The primary efficacy end point was the duration of severe neutropenia ( DSN ) ( days with an absolute neutrophil count [ ANC ] < 0.5 10 ( 9 ) cells/L ) during cycle 1 .


Efficacy analyses were performed in the per-protocol ( PP ) population .


In a separate open-label single-arm study , newly recruited patients ( n = 77 ) received balugrastim 40 mg and were included in the safety analysis .


The mean DSN in cycle 1 was 1.1 days in the balugrastim group and 1.0 days in the pegfilgrastim group ( 95 % confidence interval [ CI ] , -0.13 -0.37 ) .


Two and 4 patients , respectively , had febrile neutropenia during cycle 1 .


Twenty percent of patients in the balugrastim group and 19 % in the pegfilgrastim group had adverse events ( AEs ) considered to be related to study medication ; 3.9 % and 4.7 % of patients , respectively , experienced serious AEs .


This study demonstrates the comparable safety and efficacy profile of balugrastim and pegfilgrastim and the noninferiority of balugrastim for reduction in DSN .


There were no unexpected safety events .


Variations in institutional practice may contribute to different outcomes of cancer treatment .


The impact of interinstitutional heterogeneity on outcomes between hospitals after oesophagectomy has not been examined previously using data from surgical clinical trials .


The data from two phase III trials for oesophageal cancer were used .


Japan Clinical Oncology Group ( JCOG ) 9204 involved oesophagectomy ( 92-OP ) versus oesophagectomy plus postoperative chemotherapy ( 92-POST ) , with accrual from 1992 to 1997 .


JCOG9907 involved postoperative chemotherapy ( 99-POST ) versus preoperative chemotherapy ( 99-PRE ) , with accrual from 2000 to 2006 .


Hospitals contributing fewer than three patients were excluded .


The influence of time and preoperative chemotherapy on interinstitutional heterogeneity related to postoperative complications and 5-year overall survival were evaluated by comparisons within and between these trial groups .


Heterogeneity was estimated by a mixed-effects model after adjusting for age , sex , performance status , location of the primary tumour and clinical stage .


Twelve hospitals in 92-OP ( 114 patients ) , 13 in 92-POST ( 114 ) , 19 in 99-POST ( 158 ) and 18 in 99-PRE ( 154 ) were eligible .


There was considerable heterogeneity in predicted postoperative complications in both groups in JCOG9204 ( median 31.3 ( range 15.0-68 .2 ) per cent ) , and in 99-PRE ( 35.2 ( 22.6-46 .6 ) per cent ) but not in 99-POST ( 27.7 ( 27.7-27 .7 ) per cent ) from JCOG9907 .


A similar pattern was seen for predicted overall survival ( 92-POST : 66.4 ( range 64.1-68 .9 ) per cent ; 99-PRE : 55.9 ( 54.0-59 .7 ) per cent ; 99-POST : 44.4 ( 44.4-44 .4 ) per cent ) .


Interinstitutional heterogeneity regarding complications and survival after oesophagectomy is a problem that merits wider consideration .


Hemodialysis patients are high absorbers of intestinal cholesterol ; they benefit less than other patient groups from statin therapy , which inhibits cholesterol synthesis .


This study sought to investigate whether the individual cholesterol absorption rate affects atorvastatin 's effectiveness to reduce cardiovascular risk in hemodialysis patients .


This post-hoc analysis included 1,030 participants in the German Diabetes and Dialysis Study ( 4D ) who were randomized to either 20 mg of atorvastatin ( n = 519 ) or placebo ( n = 511 ) .


The primary endpoint was a composite of major cardiovascular events .


Secondary endpoints included all-cause mortality and all cardiac events .


Tertiles of the cholestanol-to-cholesterol ratio , which is an established biomarker of cholesterol absorption , were used to identify high and low cholesterol absorbers .


A total of 454 primary endpoints occurred .


On multivariate time-to-event analyses , the interaction term between tertiles and treatment with atorvastatin was significantly associated with the risk of reaching the primary endpoint .


Stratified analysis by cholestanol-to-cholesterol ratio tertiles confirmed this effect modification : atorvastatin reduced the risk of reaching the primary endpoint in the first tertile ( hazard ratio [ HR ] : 0.72 ; p = 0.049 ) , but not the second ( HR : 0.79 ; p = 0.225 ) or third tertiles ( HR : 1.21 ; p = 0.287 ) .


Atorvastatin consistently significantly reduced all-cause mortality and the risk of all cardiac events in only the first tertile .


Intestinal cholesterol absorption , as reflected by cholestanol-to-cholesterol ratios , predicts the effectiveness of atorvastatin to reduce cardiovascular risk in hemodialysis patients .


Those with low cholesterol absorption appear to benefit from treatment with atorvastatin , whereas those with high absorption do not benefit .


Preoperative incisional local anaesthesia with ropivacaine is a common method of providing post-laparoscopy pain relief .


The pulmonary recruitment manoeuvre also provides pain relief , but the combined effect of these two methods on pain following laparoscopic procedures has not been reported .


We investigated the efficacy of combining local anaesthetic infiltration of ropivacaine with pulmonary recruitment manoeuvre on postoperative pain following diagnostic hysteroscopy and laparoscopy .


This prospective , randomized , controlled study involved 60 patients divided into two groups ( n = 30 , each ) .


Group 1 received 20 ml of 0.5 % ropivacaine injected peri-incisionally preoperatively , with intra-abdominal carbon dioxide removed by passive deflation .


Group 2 received 20 ml of 0.5 % ropivacaine injected peri-incisionally with five manual inflations of the lungs with a positive-pressure ventilation of 40 cmH2O at the end of surgery .


The last inflation was held for 5 seconds .


The intensity of postoperative incisional and shoulder pain was evaluated using a numerical rating scale at 0 , 2 , 4 , 8 , 12 , 24 and 48 hours postoperatively by an independent blinded anaesthesiologist .


Tramadol was given postoperatively for analgesia .


Compared with group 1 , incisional ropivacaine infiltration combined with pulmonary recruitment manoeuvre significantly reduced dynamic pain at 0 hour , 4 hours , and 24 hours postoperatively ( 4.1 2.2 vs. 2.1 1.9 , P = 0.002 ; 2.7 2.7 vs. 1.2 1.3 , P = 0.035 ; and 3.5 2.1 vs. 2.1 1.8 , P = 0.03 , respectively ) .


Static incisional pain was significantly relieved at 0 hour , 2 hours , and 24 hours postoperatively ( 3.1 1.7 vs. 1.6 1.3 , P = 0.001 ; 1.4 1.3 vs. 0.5 0.8 , P = 0.012 ; and 2.3 1.9 vs. 1.0 1.5 , P = 0.038 , respectively ) .


Group 2 had more patients without shoulder pain ( P < 0.05 ) and fewer requiring tramadol ( P < 0.05 ) .


Ropivacaine with pulmonary recruitment manoeuvre provided simple and effective pain relief after diagnostic hysteroscopy and laparoscopy .


Anorexia nervosa ( AN ) , a prevalent psychiatric disorder predominantly affecting women , is characterized by self-induced starvation and low body weight .


Increased clinical fractures are common , and most women have low bone mineral density ( BMD ) .


Previously investigated treatments have led to no or modest increases in BMD in AN .


Our objective was to investigate the effect of teriparatide ( TPT ; human PTH [ 1-34 ] ) , an anabolic agent , on low bone mass in women with AN .


This randomized , placebo-controlled trial at a clinical research center included 21 women with AN : 10 ( mean age SEM , 47 2.7 years ) treated with TPT and 11 ( 47.1 2.3 years ) treated with placebo .


TPT ( 20 g s.c. ) or placebo was administered for 6 months .


Our primary outcome measure was change in BMD of the spine and hip by dual-energy x-ray absorptiometry .


Secondary outcome measures included changes in serum N-terminal propeptide of type 1 procollagen ( P1NP ) , C-terminal collagen cross-links , sclerostin , and IGF-1 levels .


At 6 months , spine BMD increased significantly more with TPT ( posteroanterior spine , 6.0 % 1.4 % ; lateral spine , 10.5 % 2.5 % ) compared with placebo ( posteroanterior spine , 0.2 % 0.7 % , P < .01 ; lateral spine , -0.6 % 1.0 % ; P < .01 ) .


The results remained significant after controlling for baseline body mass index , P1NP , and IGF-1 .


Changes in femoral neck ( P = .4 ) and total hip ( P = 0.8 ) BMD were comparable in both groups , as were changes in weight .


Serum P1NP levels increased after 3 months of TPT treatment and remained at this higher level at 6 months , whereas P1NP levels were unchanged in the placebo group ( P = .02 ) .


TPT was well-tolerated by all subjects .


This study demonstrates that TPT administration increases spine BMD substantially after only 6 months of therapy in women with AN .


Cluster immunotherapy represents an interesting alternative to conventional up-dosing schedules because it allows achieving the maintenance dose within a shorter time interval .


In this study , the efficacy and safety of cluster immunotherapy with a high polymerized allergen extract of a grass/rye pollen mixture have been evaluated in a randomized , double-blind , placebo-controlled , multicenter study .


In total , 121 patients with allergic rhinoconjunctivitis due to grass pollen were randomized 1:1 to verum or placebo group .


A short cluster up-dosing schedule of only 1week was applied to achieve the maintenance dose which was administered monthly during the study period of 1year .


Total combined symptom and medication score ( TCS ) was defined as primary outcome parameter .


Secondary outcome parameters were individual symptom and medication scores , ` well days , ' global improvement as well as immunological effects and nasal allergen challenge .


The safety profile was evaluated based on the European academy of allergy and clinical immunology grading system .


Significant reduction in the verum compared to the placebo group ( intention-to-treat , population , verum : n = 55 ; placebo : n = 47 ) was found regarding TCS ( P = 0.005 ) , rhinoconjunctivitis total symptom score ( RTSS , P = 0.006 ) , and total rescue medication score ( TRMS , P = 0.002 ) .


Additionally , secondary outcomes such as ` well days , ' nasal challenge results , and increase of specific IgG4 were in favor of the active treatment .


All systemic adverse reactions ( 0.8 % of all injections in the verum group ) were of mild intensity .


No severe reactions related to the study medication were observed .


Cluster immunotherapy with high polymerized grass pollen extracts resulted in significant clinical efficacy and has been shown to be a safe treatment for grass pollen-allergic patients .


Patients with idiopathic pulmonary fibrosis ( IPF ) have severely limited exercise capacity due to dyspnea , hypoxemia , and abnormal lung mechanics .


This pilot study was designed to determine whether pulmonary rehabilitation were efficacious in improving the 6-min walk test ( 6-MWT ) distance , exercise oxygen uptake , respiratory muscle strength [ maximum inspiratory pressure ( MIP ) ] , and dyspnea in patients with IPF .


Underlying physiological mechanisms and effects of the intervention were investigated .


Subjects were randomly assigned to a 3-month pulmonary rehabilitation program ( n = 11 ) or to a control group ( n = 10 ) .


All subjects initially underwent the 6-MWT and constant load exercise gas exchange studies .


Subjects in the rehabilitation group increased treadmill exercise [ metabolic equivalent of task-minutes ] over the first 14 sessions .


Beneficial effects on physical function resulted in those who completed rehabilitation .


Subjects who completed the program increased cycle ergometer time and maintained exercise oxygen consumption ( exercise VO ( 2 ) ) at the baseline level over 3 months , while the control group suffered a significant decrease in exercise VO ( 2 ) .


Rehabilitation subjects also increased their MIP .


Plasma lactate doubled and brain natriuretic peptide levels increased significantly after exercise , as did the plasma amino acids glutamic acid , arginine , histidine , and methionine .


These changes were associated with significant decreases in arterial oxygen saturation and increases in 15-F ( 2t ) - isoprostanes after exercise .


Pulmonary rehabilitation effectively maintained exercise oxygen uptake over 3 months and lengthened constant load exercise time in patients with moderately severe IPF .


Exercise endurance on cycle ergometry testing was limited by dyspnea and severe hypoxemia associated with systemic oxidant stress .


Silent infarction in the brain can be detected in around 34 per cent of patients after carotid endarterectomy ( CEA ) and 54 per cent after carotid angioplasty and stenting ( CAS ) .


This study compared the risk of new infarctions in the brain in patients undergoing CEA or CAS .


Consecutive patients with internal carotid artery ( ICA ) stenosis exceeding 70 per cent were screened for inclusion in this prospective study .


Patients with indications for intervention , and eligible for both methods , were allocated randomly to CEA or CAS .


Neurological examination , cognitive function tests and MRI of the brain were undertaken before and 24h after intervention .


Of 150 randomized patients , 73 ( 47 men ; mean age 649 ( 71 ) years ) underwent CEA and 77 ( 58 men ; 664 ( 75 ) years ) had CAS .


New infarctions on MRI were found more frequently after CAS ( 49 versus 25 per cent ; P = 0002 ) .


Lesion volume was also significantly greater after CAS ( P = 0010 ) .


Multiple logistic regression analyses identified intervention in the right ICA as the only independent predictor of brain infarction ( odds ratio 210 , 95 per cent c.i. 103 to 425 ; P = 0040 ) .


Stroke or transient ischaemic attack occurred in one patient after CEA and in two after CAS .


No significant differences were found in cognitive test results between the groups .


These data confirm a higher risk of silent infarction in the brain on MRI after CAS in comparison with CEA , but without measurable change in cognitive function .


NCT01591005 ( http://www.clinicaltrials.gov ) .


To compare ocular surface changes after strabismus surgery with different incisions .


One hundred and twenty eyes with exotropia were randomly assigned to Group A ( limbal incision ) or Group B ( fornix incision ) .


Dry eye questionnaire , corneal sensitivity , tear film breakup time ( TFBUT ) , Schirmer I test ( SIT ) , and corneal fluorescein staining ( CFS ) were assessed at 1 day preoperatively and at different postoperative times .


In the A group , dry eye questionnaire scores increased and TFBUT decreased at postoperative weeks 1 , 2 , and 4 .


Corneal sensitivity decreased at postoperative weeks 1 and 2 .


In the B group , dry eye questionnaire scores increased and TFBUT decreased at postoperative weeks 1 and 2 .


Corneal sensitivity did not change .


Postoperative between-group differences were significant in dry eye questionnaire scores ( P = 0.0009 , 1 week ; P < 0.0001 , 2 weeks ; P = 0.0001 , 4 weeks ) and TFBUT ( P = 0.004 , 1 week ; P = 0.0003 , 2 weeks ; P = 0.0001 , 4 weeks ) .


Between-group differences in CFS were significant postoperatively ( P = 0.045 , 1 week ; P = 0.020 , 2 weeks ) .


Compared to fornix incision , limbal incision results in more serious dry eye symptoms and has a greater impact on corneal sensitivity and tear film stability .


Ivacaftor is used to treat patients with CF and a G551D gating mutation ; the KONNECTION study assessed the efficacy and safety of ivacaftor in patients with CF and a non-G551D gating mutation .


Patients with CF 6-years - old with non-G551D gating mutations received ivacaftor 150mg q12h or placebo for 8weeks in this 2-part , double-blind crossover study ( Part 1 ) with a 16-week open-label extension ( Part 2 ) .


The primary efficacy outcome was absolute change in FEV1 through 8 and 24weeks of ivacaftor treatment ; secondary outcomes were changes in BMI , sweat chloride , and CFQ-R and safety through 8 and 24weeks of treatment .


Eight weeks of ivacaftor resulted in significant improvements in percent predicted FEV1 , BMI , sweat chloride , and CFQ-R scores that were maintained through 24weeks .


Ivacaftor was generally well tolerated .


Ivacaftor was efficacious in a group of patients with CF who had selected non-G551D gating mutations .


Evidence has suggested that periodontal disease is associated with an increased risk of various adverse pregnancy and birth outcomes .


However , several large clinical randomized controlled trials failed to demonstrate periodontal therapy during pregnancy reduced the incidence of adverse pregnancy and birth outcomes .


It has been suggested that the pre-conception period may be an optimal period for periodontal disease treatment rather than during pregnancy .


To date , no randomized controlled trial ( RCT ) has examined if treating periodontal disease before pregnancy reduces adverse birth outcomes .


This study aims to examine if the pre-conception treatment of periodontal disease will lead to improved periodontal status during late pregnancy and subsequent birth outcomes .


A sample of 470 ( 235 in each arm of the study ) pre-conception women who plan to conceive within one year and with periodontal disease will be recruited for the study .


All participants will be randomly allocated to the intervention or control group .


The intervention group will receive free therapy including dental scaling and root planning ( the standard therapy ) , supragingival prophylaxis , and oral hygiene education .


The control group will only receive supragingival prophylaxis and oral hygiene education .


Women will be followed throughout their pregnancy and then to childbirth .


The main outcomes include periodontal disease status in late pregnancy and birth outcomes measured such as mean birth weight ( grams ) , and mean gestational age ( weeks ) .


Periodontal disease will be diagnosed through a dental examination by measuring probing depth , clinical attachment loss and percentage of bleeding on probing ( BOP ) between gestational age of 32 and 36weeks .


Local and systemic inflammatory mediators are also included as main outcomes .


This will be the first RCT to test whether treating periodontal disease among pre-conception women reduces periodontal disease during pregnancy and prevents adverse birth outcomes .


If the effect of pre-pregnancy periodontal treatment is confirmed , this intervention could be recommended for application in low - or middle-income countries to improve both oral health and maternal and child health .


This trial is registered with Chinese Clinical Trial Registry ( ChiCTR ) : ChiCTR-TRC-12001913 .


Our aim was compare onset time of sciatic nerve blockade ( SNB ) performed distal to the subgluteal fold using four different ultrasound ( US ) - guided approaches in patients undergoing foot or ankle surgery .


Patients were assigned to one of four groups : SI patients received SNB using short-axis ( SA ) view of the SN and in-plane ( IP ) placement of block needle ( SA-IP approach ) ; LI patients received SNB using long-axis ( LA ) view of the SN and IP needle placement ( LA-IP approach ) ; SO patients received the block using SA view of the SN and out-of-plane ( OP ) needle placement ( SA-OP approach ) ; LO patients received SNB using LA view of the SN and OP needle placement ( LA-OP ) .


Primary outcome included onset time of sensory and motor SNB .


Patient satisfaction concerning the postoperative analgesia was noted .


The LI group had significantly faster onset of sensory blockade on the distribution of tibial nerve ( 16.0 5.6 vs. 23.5 3.6 ) and common peroneal nerve ( 12.5 4.3 vs. 19.1 5.4 min ) in comparison with the LO group .


The LI group had significantly faster onset of motor blockade on the distribution of tibial nerve ( 21.1 6.2 vs. 26 3.1 ) and common peroneal nerve ( 17.7 4.8 vs. 23.7 5.8 min . )


in comparison with the LO group .


The LI group had the highest rate of patient satisfaction for postoperative analgesia and the LO group had the lowest .


The LA-IP approach resulted in a rapid onset of SNB and was associated with the best satisfaction for postoperative analgesia in comparison with LA-OP , SA-IP , and SA-OP approaches for patients undergoing foot and ankle surgery .


Tick and tsetse-borne diseases ( TTBDs ) constrain livestock production in tropical and subtropical regions of the world .


Of this community of endemic diseases , East coast fever ( T. parva ) is the most important tick-borne disease ( TBD ) accounting for 70 % of all losses due to TBDS in this region where control efforts target either tsetse or TBDs and seldom both .


In those instances where simultaneous pyrethroid insecticide TTBD control is implemented , collateral benefits of tsetse control on TBD control have not been quantified .


In the interest of guiding future TTBD control efforts , the effect of restricting pyrethroid insecticides to the legs , belly and ears ( RAP ) of cattle for tsetse and trypanosomiasis control on T. parva prevalence in crop-livestock production systems in Tororo district , south-eastern Uganda was determined .


We randomly allocated 16 villages to diminazene diaceturate ( DA ) and 3 graded RAP ( 25 % , 50 % and 75 % of village herd sprayed respectively ) treatment regimens .


All cattle were ear-tagged , treated with diminazene diaceturate ( DA ) and those in regimens 2-4 received monthly graded RAP .


Blood samples taken fourteen days post DA treatment and once three monthly were analysed by molecular techniques for T. parva .


In total , 8,975 samples from 3,084 animals were analysed .


Prevalence of T. parva varied between 1-3 % in different treatment regimens .


RAP regimens were associated with slightly lower average risk of infection compared to DA .


However , the confidence interval was broad and the result was not statistically significant .


There was no evidence of a dose response relationship between graded RAP and T. parva prevalence .


These findings are discussed herein with regard to endemic stability development to different TBDs .


We found only a slight effect of RAP on T. parva infection .


Since sample size determination was based on trypanosomes incidence , the study was underpowered given the low T. parva prevalence .


While the findings need to be confirmed in future studies , the observed slight reduction in the risk of infection with T. parva might not compromise endemic stability .


To report the primary outcomes of a cluster randomized clinical trial of Behavioral Activities Intervention ( BE-ACTIV ) , a behavioral intervention for depression in nursing homes .


Twenty-three nursing homes randomized to BE-ACTIV or treatment as usual ( TAU ) ; 82 depressed long-term care residents recruited from these nursing homes .


BE-ACTIV participants received 10 weeks of individual therapy after a 2-week baseline .


TAU participants received weekly research visits .


Follow-up assessments occurred at 3 - and 6-month posttreatment .


BE-ACTIV group participants showed better diagnostic recovery at posttreatment in intent-to-treat analyses adjusted for clustering .


They were more likely to be remitted than TAU participants at posttreatment and at 3-month posttreatment but not at 6 months .


Self-reported depressive symptoms and functioning improved in both groups , but there were no significant treatment by time interactions in these variables .


BE-ACTIV was superior to TAU in moving residents to full remission from depression .


The treatment was well received by nursing home staff and accepted by residents .


A large proportion of participants remained symptomatic at posttreatment , despite taking one or more antidepressants .


The results illustrate the potential power of an attentional intervention to improve self-reported mood and functioning , but also the difficulties related to both studying and implementing effective treatments in nursing homes .


The aim of the study was to describe the prevalence and correlates of chronic obstructive pulmonary disease ( COPD ) in a multicentre international cohort of persons living with HIV ( PLWH ) .


We performed a cross-sectional analysis of adult PLWH , nave to HIV treatment , with baseline CD4 cell count > 500 cells/L enrolled in the Pulmonary Substudy of the Strategic Timing of AntiRetroviral Treatment ( START ) trial .


We collected standardized , quality-controlled spirometry .


COPD was defined as forced expiratory volume in 1s : forced vital capacity ( FEV1 : FVC ) ratio less than the lower limit of normal .


Among 1026 participants from 80 sites and 20 countries , the median age was 36 [ interquartile range ( IQR ) 30 , 44 ] years , 29 % were female , and the median time since HIV diagnosis was 1.2 ( IQR 0.4 , 3.5 ) years .


Baseline median CD4 cell count was 648 ( IQR 583 , 767 ) cells/L , median viral load was 4.2 ( IQR 3.5 , 4.7 ) log10 HIV-1 RNA copies/mL , and 10 % had a viral load 400 copies/mL despite lack of HIV treatment .


Current/former/never smokers comprised 28 % / 11 % / 61 % of the cohort , respectively .


COPD was present in 6.8 % of participants , and varied by age , smoking status and region .


Forty-eight per cent of those with COPD reported lifelong nonsmoking .


In multivariable regression , age and pack-years of smoking had the strongest associations with FEV1 : FVC ratio ( P < 0.0001 ) .


There was a significant effect of region on FEV1 : FVC ratio ( P = 0.010 ) .


Our data suggest that , among PLWH who were nave to HIV treatment and had CD4 cell counts > 500 cells/L , smoking and age were important factors related to COPD .


Smoking cessation should remain a high global priority for clinical care and research in PLWH .


Remote ischemic preconditioning has gained clinicians ' attention as a technique to protect the heart in patients undergoing cardiac surgery under cardiopulmonary bypass .


While experimental data report neuroprotective properties of remote ischemic preconditioning , we failed to find any clinical studies investigating its effects on neurologic outcome in cardiac surgery .


This prospective randomized placebo-controlled study was undertaken with the aim of elucidating the role of remote ischemic preconditioning for neuroprotection in cardiac surgery .


88 patients with coronary heart disease scheduled for on-pump coronary bypass grafting surgery were randomized to receive either remote ischemic preconditioning or control .


We studied S100B peptide and neuron-specific enolase to assess neurological damage .


Psychophysiological tests were employed to investigate cognitive function after surgery .


The perioperative dynamics of S100B and neuron-specific enolase followed similar patterns in both groups throughout the observation period .


At the end of surgery , level of S100B was significantly higher in the preconditioning group as compared to controls -- 0.58 ( 0.33-0 .65 ) vs. 0.34 ( 0.23-0 .42 ) mcg/l , p < O. 01 ) .


No other significant between-group differences in biochemical markers were observed .


No between-group differences in cognitive function and neurologic outcome after surgery were detected .


Our data suggest that remote ischemic preconditioning does not affect neuronal damage and neurologic outcome in patients operated under cardiopulmonary bypass .


One of the pressing concerns in health care today is the slow rate at which promising interventions , supported by research evidence , move into clinical practice .


One potential way to speed this process is to conduct hybrid studies that simultaneously combine the collection of effectiveness and implementation relevant data .


This paper presents implementation relevant data collected during a randomized effectiveness trial of an abstinence incentive intervention conducted in substance use disorders treatment clinics at two Veterans Health Administration ( VHA ) medical centers .


Participants included patients entering substance use disorders treatment with diagnoses of alcohol dependence and/or stimulant dependence that enrolled in the randomized trial , were assigned to the intervention arm , and completed a post intervention survey ( n = 147 ) .


All staff and leadership from the participating clinics were eligible to participate .


A descriptive process evaluation was used , focused on participant perceptions and contextual/feasibility issues .


Data collection was guided by the RE-AIM and PARIHS implementation frameworks .


Data collection methods included chart review , intervention cost tracking , patient and staff surveys , and qualitative interviews with staff and administrators .


Results indicated that patients , staff and administrators held generally positive attitudes toward the incentive intervention .


However , staff and administrators identified substantial barriers to routine implementation .


Despite the documented low cost and modest staff time required for implementation of the intervention , securing funding for the incentives and freeing up any staff time for intervention administration were identified as primary barriers .


Recommendations to facilitate implementation are presented .


Recommendations include : 1 ) solicit explicit support from the highest levels of the organization through , for example , performance measures or clinical practice guideline recommendations ; 2 ) adopt the intervention incrementally starting within a specific treatment track or clinic to reduce staff and funding burden until local evidence of effectiveness and feasibility is available to support spread ; and 3 ) educate staff about the process , goals , and value/effectiveness of the intervention and engage them in implementation planning from the start to enhance investment in the intervention .


Bevacizumab , a monoclonal antibody that targets VEGF , has shown restricted activity in patients with advanced melanoma .


We aimed to assess the role of bevacizumab as adjuvant treatment for patients with resected melanoma at high risk of recurrence .


We report results from the preplanned interim analysis .


We did a multicentre , open-label , randomised controlled phase 3 trial at 48 centres in the UK between July 18 , 2007 , and March 29 , 2012 .


Patients aged 16 years or older with American Joint Committee on Cancer stage ( AJCC ) stage IIB , IIC , and III cutaneous melanoma were randomly allocated ( 1:1 ) , via a central , computer-based minimisation procedure , to receive intravenous bevacizumab 7.5 mg/kg , every 3 weeks for 1 year , or to observation .


Randomisation was stratified by Breslow thickness of the primary tumour , N stage according to AJCC staging criteria , ulceration of the primary tumour , and patient sex .


The primary endpoint was overall survival ; secondary endpoints included disease-free interval , distant-metastases interval and quality of life .


Analysis was by intention-to-treat .


This trial is registered as an International Standardised Randomised Controlled Trial , number ISRCTN81261306 .


1343 patients were randomised to either the bevacizumab group ( n = 671 ) or the observation group ( n = 672 ) .


Median follow-up was 25 months ( IQR 16-37 ) in the bevacizumab group and 25 months ( 17-37 ) in the observation group .


At the time of interim analysis , 286 ( 21 % ) of 1343 enrolled patients had died : 140 ( 21 % ) of 671 patients in the bevacizumab group , and 146 ( 22 % ) of 672 patients in the observation group .


134 ( 96 % ) of patients in the bevacizumab group died because of melanoma versus 139 ( 95 % ) in the observation group .


We noted no significant difference in overall survival between treatment groups ( hazard ratio [ HR ] 0.97 , 95 % CI 0.78-1 .22 ; p = 0.76 ) ; this finding persisted after adjustment for stratification variables ( HR 1.03 ; 95 % CI 0.81-1 .29 ; p = 0.83 ) .


Median duration of treatment with bevacizumab was 51 weeks ( IQR 21-52 ) and dose intensity was 86 % ( 41-96 ) , showing good tolerability .


180 grade 3 or 4 adverse events were recorded in 101 ( 15 % ) of 671 patients in the bevacizumab group , and 36 ( 5 % ) of 672 patients in the observation group .


Bevacizumab resulted in a higher incidence of grade 3 hypertension than did observation ( 41 [ 6 % ] vs one [ < 1 % ] ) .


There was an improvement in disease-free interval for patients in the bevacizumab group compared with those in the observation group ( HR 0.83 , 95 % CI 0.70-0 .98 , p = 0.03 ) , but no significant difference between groups for distant-metastasis-free interval ( HR 0.88 , 95 % CI 0.73-1 .06 , p = 0.18 ) .


No significant differences were noted between treatment groups in the standardised area under the curve for any of the quality-of-life scales over 36 months .


Three adverse drug reactions were regarded as both serious and unexpected : one patient had optic neuritis after the first bevacizumab infusion , a second patient had persistent erectile dysfunction , and a third patient died of a haemopericardium after receiving two bevacizumab infusions and was later identified to have had significant predisposing cardiovascular risk factors .


Bevacizumab has promising tolerability .


Longer follow-up is needed to identify an effect on the primary endpoint of overall survival at 5 years .


No long-term studies have compared centrally acting drugs for treating obesity .


To compare the efficacy and safety of diethylpropion ( DEP ) , fenproporex ( FEN ) , mazindol ( MZD ) , fluoxetine ( FXT ) and sibutramine ( SIB ) in promoting weight loss .


A prospective , randomized , placebo ( PCB ) - controlled study conducted at a single academic institution .


A total of 174 obese premenopausal women .


Participants randomly received DEP 75mg ( n = 28 ) , FEN 25mg ( n = 29 ) , MZD 2mg ( n = 29 ) , SIB 15mg ( n = 30 ) , FXT 20mg ( n = 29 ) or PCB ( n = 29 ) daily over 52 weeks .


Diet and physical activity were encouraged .


The primary endpoints were changes in body weight and the proportion of women who achieved at least 5 % weight loss by week 52 in the intent-to-treat population .


Other measurements included anthropometry , safety , metabolic and cardiovascular parameters .


Weight loss was greater than PCB ( -3.14.3 kg ) with DEP ( -10.06.4 kg ; P < 0.001 ) , SIB ( -9.55.9 kg ; P < 0.001 ) , FEN ( -7.86.9 kg ; P < 0.01 ) and MZD ( -7.44.9 kg ; P < 0.01 ) but not with FXT ( -2.54.1 kg ) .


Ten ( 33.3 % ) women lost5 % of their initial weight with PCB , compared with 20 ( 71.4 % ; P < 0.001 ) with DEP , 20 ( 69 % ; P < 0.02 ) with FEN , 21 ( 72.4 % ; P < 0.01 ) with MZD , 22 ( 73.3 % ; P < 0.001 ) with SIB and 10 ( 35.5 % ) with FXT .


Each medically treated group experienced more adverse events compared with PCB ( P < 0.001 ) .


Compared with PCB , constipation was more prevalent with DEP , SIB and MZD ( P < 0.01 ) ; anxiety was more prevalent with DEP ( P = 0.01 ) ; and irritability occurred more frequently with DEP and FEN ( P = 0.02 ) .


Significant improvements in the depression and anxiety scores , binge-eating episodes and quality of life correlated with weight loss .


The centrally acting drugs DEP , FEN , MZD and SIB were more effective than PCB in promoting weight loss in obese premenopausal women , with a satisfactory benefit-risk profile .


Apathy is the most common neuropsychiatric symptom in Alzheimer 's disease ( AD ) and it is associated with changes in prefrontal neural circuits involved with generation of voluntary actions .


To date no effective treatment for apathy has been demonstrated .


We aimed to investigate the effects and safety of repetitive transcranial direct current stimulation ( tDCS ) on apathy in moderate AD patients .


Forty patients were randomized to receive either active or sham-tDCS over the left dorsolateral prefrontal cortex ( DLPFC ) .


Patients received six sessions of intervention during 2 weeks and were evaluated at baseline , at week 1 and 2 , and after 1 week without intervention .


Clinical raters , patients , and caregivers were blinded .


The primary outcome was apathy .


Global cognition and neuropsychiatric symptoms were examined as secondary outcomes .


The mean MMSE score at baseline was 15.2 2.9 and the mean Apathy Scale score was 27.7 6.7 .


Changes on apathy scores over time were not different between active and sham tDCS ( P = 0.552 for repeated measures ) .


Further analyses confirm that changes from baseline did not differ between groups after the sixth session ( active tDCS -1.95 ( 95 % CI -3.49 , -0.41 ) ; sham-tDCS -2.05 ( 95 % CI -3.68 , -0.42 ) ; P = 0.989 ] .


Similarly , tDCS had no effect on secondary outcomes ( P > 0.40 ) .


tDCS was well tolerated and not associated with significant adverse effects .


In this adequately powered study for minimal clinically significant difference , our findings show that using the parameters we chose for this study , repeated anodal tDCS over the left DLPFC had no effect on apathy in elderly patients with moderate AD .


We sought to identify the program fidelity factors associated with successful implementation of the Buckle-Up Safely program , targeting correct use of age-appropriate child car restraints .


In 2010 , we conducted a cluster randomized controlled trial of 830 families with children attending preschools and long day care centers in South West Sydney , New South Wales , Australia .


Families received the Buckle-Up Safely program in the intervention arm of the study ( 13 services ) .


Independent observers assessed the type of restraint and whether it was used correctly .


This detailed process evaluation showed that the multifaceted program was implemented with high fidelity .


Program protocols were adhered to and messaging was consistently delivered .


Results from multilevel and logistic regression analyses show that age-appropriate restraint use was associated with attendance at a parent information session hosted at the center ( adjusted odd ratio [ AOR ] = 3.66 ; 95 % confidence interval [ CI ] = 1.61 , 8.29 ) and adversely affected by the child being aged 2 to 3 years ( AOR = 0.14 ; 95 % CI = 0.07 , 0.30 ) or being from a family with more than 2 children ( AOR = 0.34 ; 95 % CI = 0.17 , 0.67 ) .


Findings highlight the importance of parents receiving hands-on education regarding the proper use of age-appropriate child restraints .


frail older people often require tailored rehabilitation in order to remain at home , especially following a period of hospitalisation .


Restorative care services aim to enhance an older person 's ability to remain improve physical functioning , either at home or in residential care but evidence of their effectiveness is limited .


to evaluate the effectiveness of a restorative care service on institutional-free survival and health outcomes in frail older people referred for needs assessment in New Zealand .


a randomised controlled trial of restorative care or usual care in 105 older people at risk of permanent residential who were follow-up over 24 months .


The restorative care service was delivered in short-stay residential care facilities and at participants ' residences with the aim of reducing the requirement for permanent residential care .


It included a comprehensive geriatric assessment and care plan developed and delivered , initially by a multi-disciplinary team and subsequently by home care assistants .


compared with usual care , there was a non-significant absolute risk reduction of 14.3 % for death or permanent residential care ( 8.8 % for residential care and 7.2 % for death alone ) for the restorative care approach .


There was no difference in levels of burden among caregivers .


restorative care models that utilise case management and multi-disciplinary care may positively impact on institutional-free survival for frail older people without adversely impacting on the health of caregivers .


Isotopic glomerular filtration rate ( iGFR ) measurement is comparable to the inulin method .


In this study , we compared urinary and plasma iGFR methodologies in patients with diabetic nephropathy .


A total of 147 patients from 3 sites in the Diabetic Intervention with Vitamins to Improve Nephropathy ( DIVINe ) trial provided 213 sets of urine and blood collections , at baseline , 18 and 36 months .


The mean ( with standard deviation ) plasma iGFR of 60.7 ( 24.9 ) ml/min/1 .73 m ( 2 ) compared to urinary iGFR of 52.0 ( 28.0 ) ml/min/1 .73 m ( 2 ) was statistically significant ( p value < 0.001 ) .


Although plasma and urinary iGFRs were highly related ( R ( 2 ) = 0.86 ) , plasma iGFR increasingly overestimated urinary iGFRs at lower GFRs .


In contrast to the cross-sectional analyses , the two measures of iGFR were weakly related ( R ( 2 ) = 0.32 ) in regard to patients ' change over 18 months of follow-up .


Plasma iGFR may not be a suitable method for accurately measuring GFR in patients with advancing degrees of chronic kidney disease from diabetic nephropathy .


Latinos experience significant health disparities at the end of life compared with non-Latinos .


To determine the feasibility of a patient navigator intervention to improve palliative care outcomes for Latino adults with serious illness .


This was a pilot randomized controlled trial that included 64 Latino adults with life-limiting illness randomized to an intervention or a control group .


All participants received a packet of linguistically matched materials on palliative care .


In addition , intervention participants received up to five home visits from the bilingual , bicultural patient navigator .


Visits focused on addressing barriers to palliative care through education , activation , and culturally tailored messaging .


Outcomes included feasibility and advance care planning rates , documentation of pain management discussions in the medical record , and hospice utilization .


Of the 32 patients randomized to the intervention arm , 81 % had at least one home visit ( range 1-5 ) with the patient navigator .


Overall , advance care planning was higher in the intervention group ( 47 % [ n = 15 ] vs. 25 % [ n = 8 ] , P = 0.06 ) , and 79 % of intervention participants had a discussion about pain management documented in their medical record vs. 54 % of control patients ( P = 0.05 ) .


Hospice enrollment between the two groups ( n = 18 decedents ) was similar ( n = 7 intervention vs. n = 6 control ) ; length of stay in the intervention group was 36.451.6 vs. 19.733.6 days for control patients ( P = 0.39 ) .


A culturally tailored patient navigator intervention was feasible and suggests improved palliative care outcomes for Latinos facing advanced medical illness , justifying a fully powered randomized controlled trial .


To compare the impact of unconditional and conditional financial incentives on response rates among Australian general practitioners invited by mail to participate in an online survey about cancer care and to investigate possible differential response bias between incentive groups .


Australian general practitioners were randomly allocated to unconditional incentive ( book voucher mailed with letter of invitation ) , conditional incentive ( book voucher mailed on completion of the online survey ) , or control ( no incentive ) .


Nonresponders were asked to complete a small subset of questions from the online survey .


Among 3,334 eligible general practitioners , significantly higher response rates were achieved in the unconditional group ( 167 of 1,101 , 15 % ) compared with the conditional group ( 118 of 1,111 , 11 % ) ( P = 0.0014 ) , and both were significantly higher than the control group ( 74 of 1,122 , 7 % ; both P < 0.001 ) .


Although more positive opinions about cancer care were expressed by online responders compared with nonresponders , there was no evidence that the magnitude of difference varied by the incentive group .


The incremental cost for each additional 1 % increase above the control group response rate was substantially higher for the unconditional incentive group compared with the conditional incentive group .


Both unconditional and conditional financial incentives significantly increased response with no evidence of differential response bias .


Although unconditional incentives had the largest effect , the conditional approach was more cost-effective .


Lipophilic opioids and local anesthetics are often given intrathecally in combination for labor analgesia .


However , the nature of the pharmacologic interaction between these drugs has not been clearly elucidated in humans .


Three hundred nulliparous women randomly received 1 of 30 different combinations of fentanyl and bupivacaine intrathecally using a combined spinal-epidural technique for analgesia in the first stage of labor .


Visual analogue scale pain scores were recorded for 30 min .


Response was defined by percentage decrease in pain score from baseline at 15 and 30 min .


Dose-response curves for individual drugs were fitted to a hyperbolic dose-response model using nonlinear regression .


The nature of the drug interaction was determined using dose equivalence methodology to compare observed effects of drug combinations with effects predicted by additivity .


The derived dose-response models for individual drugs ( doses in micrograms ) at 15 min were : Effect = 100 dose / ( 13.82 + dose ) for fentanyl , and Effect = 100 dose / ( 1,590 + dose ) for bupivacaine .


Combinations of fentanyl and bupivacaine produced greater effects than those predicted by additivity at 15 min ( P < 0.001 ) and 30 min ( P = 0.015 ) ( mean differences , 9.1 [ 95 % CI , 4.1-14 .1 ] and 6.4 [ 95 % CI , 1.2-11 .5 ] units of the normalized response , respectively ) , indicating a synergistic interaction .


The pharmacologic interaction between intrathecal fentanyl and bupivacaine is synergistic .


Characterization and quantification of this interaction provide a theoretical basis and support for the clinical practice of combining intrathecal opioids and local anesthetics .


The objective of this study was to determine the cost-effectiveness of intra-arterial treatment within the 0 - to 6-hour window after intravenous tissue-type plasminogen activator within 0 - to 4.5-hour compared with intravenous tissue-type plasminogen activator alone , in the US setting and from a social perspective .


A decision analytic model estimated the lifetime costs and outcomes associated with the additional benefit of intra-arterial therapy compared with standard treatment with intravenous tissue-type plasminogen activator alone .


Model inputs were obtained from published literature , the Multicenter Randomized Clinical Trial of Endovascular Therapy for Acute Ischemic Stroke in the Netherlands ( MR CLEAN ) study , and claims databases in the United States .


Health outcomes were measured in quality-adjusted life years ( QALYs ) .


Treatment benefit was assessed by calculating the cost per QALY gained .


One-way and probabilistic sensitivity analyses were performed to estimate the overall uncertainty of model results .


The addition of intra-arterial therapy compared with standard treatment alone yielded a lifetime gain of 0.7 QALY for an additional cost of $ 9911 , which resulted in a cost of $ 14 137 per QALY .


Multivariable sensitivity analysis predicted cost-effectiveness ( $ 50 000 per QALY ) in 97.6 % of simulation runs .


Intra-arterial treatment after intravenous tissue-type plasminogen activator for patients with anterior circulation strokes within the 6-hour window is likely cost-effective .


From a societal perspective , increased investment in access to intra-arterial treatment for acute stroke may be justified .


To compare clinical and radiographic success rates of a modified primary root canal filling ( ingredients : zinc oxide-eugenol , iodoform and calcium hydroxide , MPRCF ) vs. zinc oxide-eugenol cement ( ZOE ) and calcium hydroxide/iodoform paste ( Vitapex ) in pulpectomized primary molars at the end of 6 and 12 months , and to evaluate the degradation of materials in the root canals and in apical area .


In the study , 160 primary molars from 155 children ( the average age : 5.881.27 years ) that met the inclusion criteria were allocated to one of the three materials via block randomization .


A two-visit pulpectomy was performed by an investigator .


The clinical and radiographic diagnoses were blindly assessed by other two investigators .


At the end of 6 and 12 months , the ZOE and MPRCF success rates were 100 % both in clinical and radiographic evaluation .


The Vitapex group showed the clinical success of 100 % at the end of 6 months and 94.5 % at the end of 12 months .


Radiographic evaluation for the Vitapex group showed 80.4 % success at the end of 6 months and 60.7 % at the end of 12 months .


No statistically significant differences were noted at the end of 6 months in the three groups both in clinical and radiographic evaluation .


The success rates in clinical and radiographic evaluation at the end of 12 months for ZOE and MPRCF groups were not significantly different , and better than those for Vitapex group with statistically significant difference .


The completely resorb rate of excess extruded extraradicularly were 14.3 % , 100 % and 71.4 % for ZOE , Vitapex and MPRCF at the end of 12 months .


The rates of resorption of material at the same rate of the root were 5.8 % , 7.2 % and 40.9 % for ZOE , Vitapex and MPRCF at the end of 12 months .


MPRCF , a mixture of zinc oxide eugenol and iodoform with calcium hydroxide can be used as a root canal filling material in primary teeth , taking account of the success rate and resorbing at a similar rate with the roots of the primary teeth .


To evaluate the effectiveness of platelet-rich fibrin ( PRF ) in preventing the development of alveolar osteitis ( AO ) .


In a double-blinded study , patients with bilateral impacted mandibular third molars underwent surgical extractions , with one socket receiving PRF and the other one serving as a control .


The surgeon and patient were unaware of the study or control side .


The predictor variable was the PRF application and was categorized as PRF and non-PRF .


The outcome variable was the development of AO during the first postoperative week .


Other study variables included age , gender , smoking status , irrigation volume , extraction difficulty , surgeon experience , and number of anesthetic cartridges .


Data were analyzed using ( 2 ) and t tests , with the significance level set at a P value less than .05 .


Seventy-eight patients ( mean age , 25 yr ) underwent 156 impacted third molar surgeries .


The overall frequency of AO was 14.74 % for all surgeries .


The frequency of AO in the PRF group was significantly lower than in the non-PRF group ( odds ratio = 0.44 ; P < .05 ) .


Based on the results of the present study , PRF application may decrease the risk of AO development after mandibular third molar surgery .


The present study examined the effect of reducing sprint interval training ( SIT ) work-interval duration on increases in maximal and submaximal performance .


Subjects ( n = 36 ) were assigned to one of three training groups : endurance training ( ET ; 60 min per session for weeks 1-2 , increasing to 75 min per session for weeks 3-4 ) , or sprint interval training consisting of either repeated 30 ( SIT 30 ) or 15 ( SIT 15 ) second all-out intervals ( starting with 4 bouts per session for weeks 1-2 , increasing to 6 intervals per session for weeks 3-4 ) .


Training consisted of cycling 3 times per week for 4 weeks .


While there was a significant main effect of training on VOpeak such that VOpeak was elevated post-training , no significant difference was observed in the improvements observed between groups ( ET ~ 13 % , SIT 30-4 % , SIT 15-8 % ) .


A significant main effect of training was observed such that lactate threshold and critical power were higher during post-testing across all groups ( p < 0.05 ) .


There was a main effect of training ( p < 0.05 ) on Wingate peak power with no differences observed between groups at post-training .


Together , these results indicate that reducing SIT work-interval duration from 30 to 15 s had no impact on training-induced increases in aerobic or anaerobic power , or on increases in lactate threshold ( absolute ) and critical power .


This study aimed to test the hypothesis that the i-gel supraglottic airway device would fit the larynx and provide better sealing pressure if prewarmed to 42C relative to the device kept at room temperature in non-paralysed , sedated patients .


A total of 74 adult patients were assigned to the warm ( i-gel prewarmed to 42C ; W group ; 37 patients ) or the control ( i-gel kept at room temperature ; C group ; 37 patients ) groups .


Anaesthesia was induced with propofol and fentanyl .


The i-gel was prewarmed to 42C for 30min before insertion in the W group , but kept at room temperature ( approximately 23C ) for the C group .


The number of attempts made until successful insertion and sealing pressure were compared between the two groups .


Insertion was successful with one attempt in 35 cases each for the W and C groups .


Two attempts were needed in two cases for the W group and one case for the C group .


There was one failed attempt in the C group , but none in the W group .


None of the differences between the two groups were significant ( p = 0.51 ) .


Sealing pressure was slightly , but not significantly , higher in the W group than in the C group ( W group 22.66.1 cmH2O ; C group 20.76.1 cmH2O ; p = 0.15 ) .


Prewarming of the i-gel to 42C did not increase the success rate of insertion , nor did it significantly increase sealing pressure in anaesthetised , non-paralysed patients .


Our data suggest that we can keep the i-gel at room temperature for emergency airway management for non-paralysed , sedated patients .


University Medical Information Network , Japan 000012287 .


Although exercise has multiple health benefits , relatively little attention has been paid to its potential therapeutic effects in those with asthma .


To examine the effects of acute exercise on inflammation in physically inactive and active adults with asthma .


Fourteen adults with asthma ( n = 6 physically inactive , n = 8 physically active ) completed ( 1 ) 30 minutes of moderate-intensity exercise on a treadmill and ( 2 ) 30 minutes of rest in random order , with 4 weeks between sessions .


Exhaled nitric oxide ( eNO ) was measured before and after the intervention ( 0 , 0.5 , 1 , 2 , 4 , and 24 hours ) .


Blood inflammatory mediators were measured before and after the intervention ( 0 , 2 , and 24 hours ) .


Physically inactive participants had a significant decrease in eNO 4 hours after exercise ( -4.8 ppb,-6 .4 to-0 .5 ppb , P = .028 ) , which was not observed in physically active participants ( P = .362 ) .


Interluekin-1 receptor antagonist increased in the physically inactive group 2 hours after exercise , with this increase strongly correlated with the decrease in eNO at 4 hours ( R = -0.685 , P = .007 ) and 24 hours ( R = -0.659 , P = .014 ) after exercise .


Interleukin-6 was increased significantly 2 hours after exercise in physically inactive participants .


Blood neutrophils and nuclear factor erythroid 2-like 2 gene expression were increased 2hours after exercise in the overall cohort .


This study demonstrates that acute moderate-intensity exercise is associated with decreased eNO in physically inactive adults with asthma and suggests that interluekin-1 receptor antagonist could have a role in mediating this effect .


The attenuated response in physically active participants might be due to the sustained anti-inflammatory effects of exercise training .


Future studies should investigate the impact of exercise intensity and exercise training on airway inflammation in those with asthma .


Australian New Zealand Clinical Trials Registry ( http://www.anzctr.org.au ) , registration number ACTRN12613001014741 .


To test the effect of atorvastatin ( ATV ) and ATV plus -3 FAEEs on VLDL-TG metabolism in obese , insulin resistant men .


We carried out a 6-week randomized , placebo-controlled study to examine the effect of ATV ( 40mg/day ) and ATV plus -3 FAEEs ( 4g/day ) on VLDL-TG metabolism in 36 insulin resistant obese men .


VLDL-TG kinetics were determined using d5 - glycerol , gas chromatography-mass spectrometry and compartmental modelling .


Compared with the placebo , ATV significantly decreased VLDL-TG concentration ( -40 % , p < 0.001 ) by increasing VLDL-TG fractional catabolic rate ( FCR ) ( +47 % , p < 0.01 ) .


ATV plus -3 FAEEs lowered VLDL-TG concentration to a greater degree compared with placebo ( -46 % , p < 0.001 ) or ATV monotherapy ( -13 % , p = 0.04 ) .


This was achieved by a reduction in VLDL-TG production rate ( PR ) compared with placebo ( -32 % , p = 0.008 ) or ATV ( -20 % , p = 0.03 ) as well as a reciprocal increase in VLDL-TG FCR ( +42 % , p < 0.05 ) compared with placebo .


In insulin resistant , dyslipidaemic , obese men , ATV improves VLDL-TG metabolism by increasing VLDL-TG FCR .


The addition of 4g/day -3 FAEE to statin therapy provides further TG-lowering by lowering VLDL-TG PR .


Conventional distillers dried grains with solubles ( DDGS-CV ) , uncooked distillers dried grains with solubles ( DDGS-BPX ) and high-protein distillers dried grains ( HP-DDG ) are used in diets for pigs to provide protein and energy .


These ingredients may have different effects on body composition and energy retention .


Therefore , an experiment was conducted to determine effects of DDGS-CV , DDGS-BPX and HP-DDG on body composition and on retention of protein , lipids , and energy when fed to growing or finishing pigs .


The total organ weight was greater ( P < 0.05 ) for finishing pigs fed the HP-DDG diet than for finishing pigs fed the basal diet or the DDGS-CV diet .


Finishing pigs fed the DDGS-CV diet had greater ( P < 0.05 ) lipid gain than pigs fed the other diets , and the net energy ( NE ) for DDGS-CV was greater ( P < 0.05 ) than for DDGS-BPX , but the NE value of HP-DDG was not different from that of DDGS-CV or DDGS-BPX .


Inclusion of up to 30 % DDGS or HP-DDG in diets fed to growing or finishing pigs will not affect body composition or the retention of energy , protein and lipids , regardless of the stage of growth of pigs .


The NE value of DDGS-BPX and HP-DDG is not affected by the stage of growth of pigs , but the NE value of DDGS-CV is greater in finishing than in growing pigs .


To test by randomized prospective multicenter trial the hypothesis that pancreaticoduodenectomy ( PD ) without the use of intraperitoneal drainage does not increase the frequency or severity of complications .


Some surgeons have abandoned the use of drains placed during pancreas resection .


We randomized 137 patients to PD with ( n = 68 , drain group ) and without ( n = 69 , no-drain group ) the use of intraperitoneal drainage and compared the safety of this approach and spectrum of complications between the 2 groups .


There were no differences between drain and no-drain cohorts in demographics , comorbidities , pathology , pancreatic duct size , pancreas texture , baseline quality of life , or operative technique .


PD without intraperitoneal drainage was associated with an increase in the number of complications per patient [ 1 ( 0-2 ) vs 2 ( 1-4 ) , P = 0.029 ] ; an increase in the number of patients who had at least 1 grade 2 complication [ 35 ( 52 % ) vs 47 ( 68 % ) , P = 0.047 ] ; and a higher average complication severity [ 2 ( 0-2 ) vs 2 ( 1-3 ) , P = 0.027 ] .


PD without intraperitoneal drainage was associated with a higher incidence of gastroparesis , intra-abdominal fluid collection , intra-abdominal abscess ( 10 % vs 25 % , P = 0.027 ) , severe ( grade 2 ) diarrhea , need for a postoperative percutaneous drain , and a prolonged length of stay .


The Data Safety Monitoring Board stopped the study early because of an increase in mortality from 3 % to 12 % in the patients undergoing PD without intraperitoneal drainage .


This study provides level 1 data , suggesting that elimination of intraperitoneal drainage in all cases of PD increases the frequency and severity of complications .


To investigate the association of characteristics of type 2 diabetes mellitus ( duration and biochemical severity of diabetes ) to brain structure measured on magnetic resonance ( MR ) images , specifically testing whether more severity in metrics of diabetes is inversely correlated with brain volumes and positively correlated with ischemic lesion volumes .


This study protocol was approved by the institutional review board of each center and participants provided written informed consent .


Baseline severity of diabetes was evaluated by testing fasting plasma glucose levels , hemoglobin A1c levels , and duration of diabetes .


MR imaging was performed with fluid-attenuated inversion recovery , proton-density , T2-weighted , and T1-weighted sequences , which were postprocessed with an automated computer algorithm that classified brain tissue as gray or white matter and as normal or ischemic .


Separate linear regression models adjusted for potential confounding factors were used to investigate the relationship of the diabetes measures to MR imaging outcomes in 614 participants ( mean age , 62 years ; mean duration of type 2 diabetes mellitus , 9.9 years ) .


The mean volumes of total gray matter ( 463.9 cm ( 3 ) ) and total white matter ( 463.6 cm ( 3 ) ) were similar .


The mean volume of abnormal tissue was 2.5 cm ( 3 ) , mostly in the white matter ( 81 % white matter , 5 % gray matter , 14 % deep gray and white matter ) .


Longer duration of diabetes and higher fasting plasma glucose level were associated with lower normal ( = -0.431 and -0.053 , respectively ; P < .01 ) and total gray matter volumes ( = -0.428 and -0.053 , respectively ; P < .01 ) .


Fasting plasma glucose was also inversely correlated with ischemic lesion volume ( = -0.006 ; P < .04 ) .


Hemoglobin A1c level was not associated with any MR imaging measure .


Longer duration of diabetes is associated with brain volume loss , particularly in the gray matter , possibly reflecting direct neurologic insult ; biochemical measures of glycemia were less consistently related to MR imaging changes .


Contrary to common clinical belief , in this sample of patients with type 2 diabetes mellitus , there was no association of diabetes characteristics with small vessel ischemic disease in the brain .


Although autologous bone marrow cell ( BMC ) therapy has emerged as a promising treatment for acute myocardial infarction ( AMI ) , trials reported mixed results .


In the BONAMI trial , active smoking reduced cardiac function recovery after reperfused AMI .


Therefore , we hypothesized that variability in the functionality of BMCs retrieved from patients with cardiovascular risk factors may partly explain these mixed results .


We investigated the characteristics of progenitor cells in active smokers and non-smokers with AMI and their potential impact on BMC therapy efficacy .


Bone marrow and blood samples from 54 smoking and 47 non-smoking patients enrolled in the BONAMI cell therapy trial were analyzed .


The white BMC and CD45dimCD34 + cell numbers were higher in active smokers ( P = 0.001 , P = 0.03 , respectively ) .


In marked contrast , either bone marrow or blood endothelial progenitor CD45dimCD34 + KDR + cells ( EPCs ) were decreased in active smokers ( P = 0.005 , P = 0.04 , respectively ) .


Importantly , a multivariate analysis including cardiovascular risk factors confirmed the association between active smoking and lower EPC number in bone marrow ( P = 0.04 ) and blood ( P = 0.04 ) .


Furthermore , baseline circulating EPC count predicted infarct size decrease at three months post-AMI in non-smokers ( P = 0.01 ) but not in active smokers .


Interestingly , baseline circulating EPCs were no longer predictive of cardiac function improvement in the BMC therapy group .


These data suggest that circulating EPCs play an important role in cardiac repair post-AMI only in non-smokers and that active smoking-associated EPC alterations may participate in the impairment of cardiac function recovery observed in smokers after AMI , an effect that was overridden by BMC therapy .


Rhythmic auditory stimulation ( RAS ) improves gait velocity , cadence , and stride length in hemiplegic stroke patients , yet little is known about the effectiveness of RAS on standing balance .


To examine and compare the effectiveness on standing balance and gait parameter of two different types of gait trainings , gait training with RAS versus gait training without RAS , was compared in two groups of hemiplegic stroke patients over a three-week period ( RAS group , n = 8 ; control group = 8 ) .


Sixteen hemiplegic stroke patients were included in the study .


Standing balance was measured by using Biosway .


Stride length , gait velocity , and cadence were calculated from the number of steps and required time for a 10 m-walk .


Pre - to post-test measures showed a significant improvement in RAS group for overall stability index ( p = 0.043 ) , mediolateral index ( p = 0.006 ) , anteroposterior index ( p = 0.016 ) , gait velocity ( p = 0.012 ) , stride length ( p = 0.03 ) and cadence ( p = 0.012 ) over the control group .


The results of this study showed that RAS was an effective therapeutic method to improve gait velocity , stride length , cadence , and standing balance in hemiplegic stroke patients .


The osteoclast has been implicated in development of bone erosion in gout .


The aim of this study was to determine whether zoledronate , a potent antiosteoclast drug , influences bone erosion in people with tophaceous gout .


This was a 2-year , randomised , double-blind , placebo-controlled trial of 100 people with tophaceous gout .


Participants were randomised to annual administration of 5 mg intravenous zoledronate or placebo .


The primary endpoint was change in the foot CT bone erosion score from baseline .


Secondary endpoint was change in plain radiographic damage scores .


Other endpoints were change in bone mineral density ( BMD ) , bone turnover markers and the OMERACT-endorsed core domains for chronic gout studies .


There was no change in CT erosion scores over 2 years , and no difference between the two treatment groups at Year 1 or 2 ( p ( treat ) = 0.10 , p ( time ) = 0.47 , p ( treat * time ) = 0.23 ) .


Similarly , there was no change in plain radiographic scores over 2 years , and no difference between the two groups at Year 1 or 2 .


By contrast , zoledronate increased spine , neck of femur , total hip and total body BMD .


Zoledronate therapy also reduced the bone turnover markers P1NP and - CTX compared with placebo .


There was no difference between treatment groups in OMERACT-endorsed core domains .


Despite improvements in BMD and suppression of bone turnover markers , antiosteoclast therapy with zoledronate did not influence bone erosion in people with tophaceous gout .


These findings suggest a disconnect between responses in the healthy skeleton and at sites of focal bone erosion in tophaceous gout .


To characterize anatomic and visual outcomes in patients with full-thickness macular hole ( FTMH ) at baseline in ocriplasmin phase 3 clinical trials , focusing on the relationship between resolution of vitreomacular adhesion and FTMH closure .


Two multicenter , randomized , double-masked clinical trials .


Pharmacologic FTMH closure was one of multiple secondary endpoints .


OCT scans were obtained at baseline and at all postinjection visits , and for patients with baseline FTMH , evaluated for FTMH width , vitreomacular adhesion , and epiretinal membrane .


FTMH closure was observed in a greater proportion of ocriplasmin - vs vehicle-injected patients with baseline FTMH width 250 m ( 58.3 % vs 16.0 % , P < .001 ) and > 250 to 400 m ( 36.8 % vs 5.3 % , P = .009 ) .


Among FTMH patients in the ocriplasmin group , 2-line visual acuity gains at month 6 were achieved by a greater percentage of those who achieved hole closure at day 28 vs those who did not achieve this outcome ( 72.1 % vs 25.4 % ) .


Ocriplasmin demonstrated efficacy in closure of small and medium FTMH , and in FTMH without epiretinal membrane at baseline .


Visual acuity gains occurred more frequently when hole closure was achieved after ocriplasmin treatment compared to when this outcome did not occur .


Ocriplasmin treatment is an additional option for the management of patients with FTMH and vitreomacular adhesion .


Etanercept ( ETN ) 50mg once weekly ( QW ) or 50mg twice weekly ( BIW ) for 12weeks , followed by 50mg QW in all subjects to Week 24 improved psoriasis in patients with concomitant psoriatic arthritis in the PRESTA trial .


To use data from PRESTA to evaluate the effect of ETN in the treatment of psoriasis by Psoriasis Area Severity Index ( PASI ) body-region and component , and determine if PASI responses correlate with the Dermatology Life Quality Index ( DLQI ) .


Median time to 75 % improvement in PASI ( PASI75 ) , body - and component-specific subscales over 24weeks were estimated .


Pearson correlation coefficients determined the association between DLQI score and PASI total score , body - and component-specific subscales with ETN treatment at baseline and up to Week 24 .


In total , 748 patients from PRESTA were included ( ETN 50mg QW/QW , n = 371 ; BIW/QW , n = 377 ) .


Patients achieved PASI75 total score and 75 % improvements in all body regions and components faster on ETN 50mg BIW/QW than QW/QW ( all P < 005 ) .


Median time to 75 % improvement was faster for the head and trunk followed by upper and lower extremities , and for induration and desquamation followed by erythema and total area .


Weak to moderately positive correlations between improvements in DLQI and PASI total score ( r = 0223-0463 ) , all PASI body-specific ( r = 0114-0432 ) and component-specific ( r = 0178-0478 ) subscales were observed over 24weeks .


Etanercept treatment-response appears to occur in a body - and component-specific manner .


Changes in quality of life are not captured by PASI or its subscales .


To determine whether spinal anesthesia blunts surgical stress reactions and results in less perioperative hyperglycemia .


Prospective , randomized controlled study .


Operating room of a university hospital .


68 adult , nondiabetic ( n = 40 ) and diabetic ( n = 28 ) , ASA physical status 1 , 2 , and 3 patients patients undergoing elective total hip replacement .


General or spinal anesthesia was administered .


Blood HbA1C was measured preoperatively to identify patients with undiagnosed diabetes .


Glucose levels were checked preoperatively , then immediately after , and one hour after surgery .


A conventional glucose control protocol was used , where insulin was given when blood glucose concentrations exceeded 250 mg/dL .


Preoperative glucose levels in general and spinal anesthesia patients were comparable and not significantly different in nondiabetic and diabetic patients .


At the end of surgery and one hour after surgery , glucose levels were significantly higher in patients undergoing general anesthesia compared with baseline values in both diabetic and nondiabetic patients ( P < 0.05 ) .


In nondiabetic and diabetic patients , a significant increase in glucose level was found in patients undergoing general anesthesia versus spinal anesthesia ( P < 0.05 ) .


In patients receiving spinal anesthesia , glucose levels remained stable .


Two diabetic patients undergoing general anesthesia received insulin .


Spinal anesthesia attenuates the hyperglycemic response to surgical stimuli in diabetics and nondiabetic patients .


For patient convenience , a gemigliptin/metformin sustainedrelease fixed-dose combination ( FDC ) tablet was developed .


This study was conducted to investigate the effects of food on the pharmacokinetic ( PK ) profile of the FDC tablets .


This was an open-label , randomized , single dose , 2-period , 2-sequence crossover study in 24 healthy male volunteers .


The FDC tablets ( 25/500 mg 2 tablets ) were administered in high-fat fed and fasted states on separate occasions , and each subject was randomly allocated to each sequence with a 7-day washout period .


PK blood samplings were conducted from predose to 48 hours after dosing .


Tolerability assessments were performed throughout the study .


Nine adverse events ( AEs ) of mild intensity were reported from 8 subjects after study drug administration , and the AE frequency was similar between treatments .


No serious AEs were reported .


The PK parameters of gemigliptin and metformin were compared between fasting and fed states .


For gemigliptin , the geometric mean ratios ( GMRs ) ( fed : fasted state ) of the Cmax and AUClast were 0.886 ( 90 % confidence interval ( CI ) 0.781 - 1.006 ) and 1.021 ( 90 % CI 0.949 - 1.099 ) , respectively .


For metformin , the GMRs of the Cmax and AUClast were 0.811 ( 90 % CI 0.712 - 0.923 ) and 1.144 ( 90 % CI 1.013 - 1.291 ) , respectively .


A prolonged tmax for metformin was observed .


These results are similar to the effects of food on each component .


The FDC tablet may have a similar PK profile as that of individual drugs and is generally tolerable when administered with food .


These results indicate that the FDC tablet can be administered in the same dosing regimen as each component , especially that of metformin sustained-release .


Pneumococcal polysaccharide conjugate vaccines prevent pneumococcal disease in infants , but their efficacy against pneumococcal community-acquired pneumonia in adults 65 years of age or older is unknown .


In a randomized , double-blind , placebo-controlled trial involving 84,496 adults 65 years of age or older , we evaluated the efficacy of 13-valent polysaccharide conjugate vaccine ( PCV13 ) in preventing first episodes of vaccine-type strains of pneumococcal community-acquired pneumonia , nonbacteremic and noninvasive pneumococcal community-acquired pneumonia , and invasive pneumococcal disease .


Standard laboratory methods and a serotype-specific urinary antigen detection assay were used to identify community-acquired pneumonia and invasive pneumococcal disease .


In the per-protocol analysis of first episodes of infections due to vaccine-type strains , community-acquired pneumonia occurred in 49 persons in the PCV13 group and 90 persons in the placebo group ( vaccine efficacy , 45.6 % ; 95.2 % confidence interval [ CI ] , 21.8 to 62.5 ) , nonbacteremic and noninvasive community-acquired pneumonia occurred in 33 persons in the PCV13 group and 60 persons in the placebo group ( vaccine efficacy , 45.0 % ; 95.2 % CI , 14.2 to 65.3 ) , and invasive pneumococcal disease occurred in 7 persons in the PCV13 group and 28 persons in the placebo group ( vaccine efficacy , 75.0 % ; 95 % CI , 41.4 to 90.8 ) .


Efficacy persisted throughout the trial ( mean follow-up , 3.97 years ) .


In the modified intention-to-treat analysis , similar efficacy was observed ( vaccine efficacy , 37.7 % , 41.1 % , and 75.8 % , respectively ) , and community-acquired pneumonia occurred in 747 persons in the PCV13 group and 787 persons in placebo group ( vaccine efficacy , 5.1 % ; 95 % CI , -5.1 to 14.2 ) .


Numbers of serious adverse events and deaths were similar in the two groups , but there were more local reactions in the PCV13 group .


Among older adults , PCV13 was effective in preventing vaccine-type pneumococcal , bacteremic , and nonbacteremic community-acquired pneumonia and vaccine-type invasive pneumococcal disease but not in preventing community-acquired pneumonia from any cause .


( Funded by Pfizer ; CAPITA ClinicalTrials.gov number NCT00744263 . )


Large for gestational age infants are at increased risk of childhood obesity and maternal nutrition impacts birthweight .


The aim of this study was to assess the impact of a maternal low glycaemic index ( GI ) diet on neonatal anthropometry .


The ROLO ( Randomised Control Trial of Low Glycaemic Index Diet in Pregnancy ) study was a randomized controlled trial to assess the impact of a low GI diet versus usual diet on birthweight .


It took place in a tertiary maternity hospital in Ireland and women were randomized to receive either a low GI diet or no dietary intervention from early pregnancy to term .


Two hundred sixty-five neonates had anthropometric measurements on day 1-2 of life , 126 in the intervention group and 139 in the control group .


Measurements included birthweight , length and circumferences of the head , chest , abdominal , thigh and mid-upper arm .


A subgroup of 219 ( 82 % ) neonates also had skin-fold measurements .


Neonates whose mothers had a low GI diet in pregnancy had lower thigh circumference ( 15.91.7 cm vs. 16.61.5 cm , P = 0.04 ) .


There was no difference between the intervention and control groups in head , chest abdominal or mid-upper arm circumferences .


No difference was noted between the two groups for any skin-fold measurements ( subscapular , thigh , biceps and triceps ) .


Neonatal thigh circumference was altered by maternal low GI diet in pregnancy .


These findings suggest that maternal low GI diet is safe in pregnancy and may positively impact infant adiposity .


The aim of this study is to assess the effect of brief motivational enhancement intervention postpartum alcohol use .


This study is a single-blinded , randomized controlled effectiveness trial in which pregnant women were assigned to receive usual care or up to 5 face-to-face brief motivational enhancement sessions lasting 10-30 minutes each and occurring at study enrollment , 4 and 8 weeks after enrollment , 32 weeks of gestation , and 6 weeks postpartum .


The setting is in a large , urban , obstetrics clinic .


Participants were women who were 18 years old , < 20 weeks of gestation , and consumed alcohol during pregnancy .


Of 3438 women screened , 330 eligible women were assigned to usual care ( n = 165 ) or intervention ( n = 165 ) .


Due to missing data , we analyzed 125 in the intervention group and 126 in the usual care group .


The measurements were the proportion of women with any alcohol use and the number of drinks per day , reported via follow-up telephone interviews at 4 and 8 weeks after enrollment , 32 weeks of gestation , and 6 weeks , 6 months , and 12 months postpartum .


In random effects models adjusted for confounders , the intervention group was less likely to use any alcohol ( odds ratio 0.50 ; 95 % confidence interval [ CI ] , 0.23-1 .09 ; P = 0.08 ) and consumed fewer drinks per day ( coefficient -0.11 ; 95 % CI -0.23 -0.01 ; P = 0.07 ) than , the usual care group in the postpartum period but these differences were non-significant .


Missing data during the prenatal period prevented us from modeling prenatal alcohol use .


Brief motivational enhancement intervention delivered in an obstetrical outpatient setting did not conclusively decrease alcohol use during the postpartum period .


A randomized clinical trial compared efficacy and toxicity of standard all-trans-retinoic acid ( ATRA ) plus chemotherapy versus ATRA plus arsenic trioxide in patients with newly diagnosed , low - or intermediate-risk acute promyelocytic leukemia ( APL ) .


Here , we report health-related quality-of-life ( HRQOL ) results .


HRQOL was a secondary end point of this trial .


The European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 was used to assess HRQOL at end of induction and after consolidation therapy .


All analyses were based on 156 patients who received at least one dose of treatment , with groups defined according to randomly assigned treatment .


Primary analysis was performed , estimating mean HRQOL score over time and differences between treatment arms using a linear mixed model .


Overall , 162 patients age 18 to 70 years were enrolled .


Of these , 150 and 142 patients were evaluable for HRQOL after induction therapy and third consolidation course , respectively .


Overall compliance with HRQOL forms was 80.1 % .


The largest difference , favoring patients treated with ATRA plus arsenic trioxide , was found for fatigue severity ( mean score difference , -9.3 ; 95 % CI , -17.8 to -0.7 ; P = .034 ) at end of induction therapy .


This difference was also clinically relevant .


HRQOL differences between treatment arms at end of consolidation showed that for several scales , differences between treatment arms were marginal .


Overall , current HRQOL findings further support the use of ATRA plus arsenic trioxide as preferred first-line treatment in patients with low - or intermediate-risk APL .


The anterior cruciate ligament ( ACL ) is one of four major ligaments in the knee that provide stability during physical activity .


A tear in the ACL is characterized by joint instability that leads to decreased activity , knee dysfunction , reduced quality of life and a loss of muscle mass and strength .


While rehabilitation is the standard-of-care for return to daily function , additional surgical reconstruction can provide individuals with an opportunity to return to sports and strenuous physical activity .


Over 200,000 ACL reconstructions are performed in the United States each year , and rehabilitation following surgery is slow and expensive .


One possible method to improve the recovery process is the use of intramuscular testosterone , which has been shown to increase muscle mass and strength independent of exercise .


With short-term use of supraphysiologic doses of testosterone , we hope to reduce loss of muscle mass and strength and minimize loss of physical function following ACL reconstruction compared to standard-of-care alone .


This study is a double-blinded randomized control trial .


Men 18-50 years of age , scheduled for ACL reconstruction are randomized into two groups .


Participants randomized to the testosterone group receive intramuscular testosterone administration once per week for 8 weeks starting 2 weeks prior to surgery .


Participants randomized to the control group receive a saline placebo intramuscularly instead of testosterone .


Lean mass , muscle strength and physical function are measured at 5 time points : 2 weeks pre-surgery , 1 day pre-surgery , and 6 , 12 , 24 weeks post-surgery .


Both groups follow standard-of-care rehabilitation protocol .


We believe that testosterone therapy will help reduce the loss of muscle mass and strength experienced after ACL injury and reconstruction .


Hopefully this will provide a way to shorten the rehabilitation necessary following ACL reconstruction .


If successful , testosterone therapy may also be used for other injuries involving trauma and muscle atrophy .


NCT01595581 , REGISTRATION : May 8 , 2012 .


In most countries , alteplase given within 45 h of onset is the only approved medical treatment for acute ischaemic stroke .


The newer thrombolytic drug tenecteplase has been investigated in one randomised trial up to 3 h after stroke and in another trial up to 6 h after stroke in patients selected by advanced neuroimaging .


In the Alteplase-Tenecteplase Trial Evaluation for Stroke Thrombolysis ( ATTEST ) , we aimed to assess the efficacy and safety of tenecteplase versus alteplase within 45 h of stroke onset in a population not selected on the basis of advanced neuroimaging , and to use imaging biomarkers to inform the design of a definitive phase 3 clinical trial .


In this single-centre , phase 2 , prospective , randomised , open-label , blinded end-point evaluation study , adults with supratentorial ischaemic stroke eligible for intravenous thrombolysis within 45 h of onset were recruited from The Institute of Neurological Sciences , Glasgow , Scotland .