Three sets of spot urine samples were randomly collected throughout the day and night , along with the first morning void .


UPCR was weighted by eUCr to investigate the improvement of accuracy in using spot urine samples to predict 24h-UP .


There were strong correlation and concordance between UPCR and 24h-UP irrespective of the time of spot urine sampling , and the correlation , concordance and agreement were improved after multiplying the UPCR value by the eUCr .


Greater improvement was found in the subgroups with measured daily urine creatinine excretion 0.8 g/d and 1.2 g/d .


This investigation demonstrated that multiplying UPCR by eUCr can improve the accuracy of only using UPCR to predict 24h-UP .


Malignant pleural effusion is associated with short life expectancy and significant morbidity .


A randomized controlled trial comparing indwelling pleural catheters ( IPCs ) with talc pleurodesis found that IPCs reduced in-hospital time and the need for additional procedures but were associated with excess adverse events .


Using data from the clinical trial , we compared costs associated with use of IPCs and with talc pleurodesis .


Resource use and adverse events were captured through case report forms over the 1-year trial follow-up .


Costs for outpatient and inpatient visits , diagnostic imaging , nursing , and doctor time were obtained from the UK National Health Service reference costs and University of Kent 's Unit Costs of Health and Social Care 2011 and inflated to 2013 using the UK Consumer Price Index .


Procedure supply costs were obtained from the manufacturer .


Difference in mean costs was compared using nonparametric bootstrapping .


All costs were converted to US dollars using the Organisation for Economic Co-operation and Development Purchasing Power Parity Index .


Overall mean cost ( SD ) for managing patients with IPCs and talc pleurodesis was $ 4,993 ( $ 5,529 ) and $ 4,581 ( $ 4,359 ) , respectively .


The incremental mean cost difference was $ 401 , with 95 % CI of - $ 1,387 to $ 2,261 .


The mean cost related to ongoing drainage in the IPC group was $ 1,011 ( $ 732 ) vs $ 57 ( $ 213 ) in the talc pleurodesis group ( P = .001 ) .


This included the cost of drainage bottles , dressing changes in the first month , and catheter removal .


There was no significant difference in cost of the initial intervention or adverse events between the groups .


For patients with survival < 14 weeks , IPC is significantly less costly than talc pleurodesis , with mean cost difference of - $ 1,719 ( 95 % CI , - $ 3,376 to - $ 85 ) .


There is no significant difference in the mean cost of managing patients with IPCs compared with talc pleurodesis .


For patients with limited survival , IPC appears less costly .


isrctn.org ; No. : ISRCTN87514420 ; URL : www.isrctn.org .


In pulmonary arterial hypertension ( PAH ) , adding oral sildenafil to intravenous epoprostenol improved 6-minute walk distance ( 6MWD ) and hemodynamics and delayed time to clinical worsening in a 16-week randomized , placebo-controlled trial ( Pulmonary Arterial Hypertension Combination Study of Epoprostenol and Sildenafil [ PACES-1 ] ) .


Patients completing PACES-1 could receive sildenafil ( titrated to 80 mg , three times daily , as tolerated ) in an open-label extension study ( PACES-2 ) for 3 years ; additional therapy was added according to investigator judgment .


Survival and changes from PACES-1 baseline in World Health Organization Functional Class and 6MWD were captured .


In an open-label setting , 6MWD , an effort-dependent outcome measure , was known to have improved or to have been maintained in 59 % , 44 % , and 33 % of patients at 1 , 2 , and 3 years , respectively ; functional class was known to have improved or to have been maintained in 73 % , 59 % , and 46 % .


At 3 years , 66 % of patients were known to be alive , 24 % were known to have died , and 10 % were lost to follow-up .


Patients with PACES-1 baseline 6MWD < 325 meters without 6MWD improvement during the first 20 weeks of sildenafil treatment subsequently had poorer survival .


Although reliable assessments of safety and efficacy require a long-term randomized trial , the addition of sildenafil to background intravenous epoprostenol therapy appeared generally to be well tolerated in PAH patients .


Erlotinib , N - ( 3-ethynylphenyl ) -6,7 - bis ( 2-methoxyethoxy ) quinazolin-4-amine is approved for the treatment for non-small cell lung cancer and pancreatic cancer .


Because erlotinib is metabolized predominately by CYP3A4 , co-administration of compounds that increase CYP3A4 activity may alter the efficacy and safety of erlotinib therapy .


Two phase I studies were conducted in healthy male subjects to evaluate the effect of pre - or co-administered rifampicin , a CYP3A4 inducer , on the pharmacokinetics of erlotinib .


Study 1 included Groups A ( erlotinib 150 mg days 1 and 15 , rifampicin 600 mg days 8-14 ) and B ( erlotinib 150 mg days 1 and 15 ) in a parallel group study design .


Study 2 subjects received erlotinib 150 mg day 1 , erlotinib 450 mg day 15 , and rifampicin 600 mg days 8-18 .


The primary endpoint in each study was the ratio of exposure ( AUC0 - and C max ) between days 1 and 15 .


Urinary cortisol metabolic induction ratios were determined in Study 1 for Group A subjects only .


In Study 1 , the geometric mean ratios of AUC0 - and C max were 33 and 71 % , respectively , and the mean cortisol metabolic index increased from 7.4 to 27.0 , suggesting cytochrome P450 ( CYP ) enzyme induction .


In Study 2 , the geometric mean ratios for AUC0 - and C max were 19 and 34 % ( when dose adjusted from 450 to 150 mg erlotinib ) , respectively , a greater relative decrease than observed in Study 1 .


Erlotinib exposure ( AUC0 - and C max ) was reduced after pre - or concomitant dosing with rifampicin .


Doses of 450 mg erlotinib may be necessary to compensate for concomitant medications with strong CYP3A4 enzyme induction effect .


Radiostereometric analysis provides highly precise measurements of component micromotion relative to the bone that is otherwise undetectable by routine radiographs .


This study compared , at a minimum of five years following surgery , the micromotion of tantalum and titanium acetabular cups and femoral head penetration in highly cross-linked polyethylene liners and conventional ( ultra-high molecular weight polyethylene ) liners in active patients who had undergone total hip replacement .


This institutional review board-approved prospective , randomized , blinded study involved forty-six patients .


Patients were randomized into one of four cohorts according to both acetabular cup and polyethylene liner .


Patients received either a cementless cup with a titanium mesh surface or a tantalum trabecular surface and either a highly cross-linked polyethylene liner or an ultra-high molecular weight polyethylene liner .


Radiostereometric analysis examinations and Short Form-36 Physical Component Summary , Western Ontario and McMaster Universities Osteoarthritis Index ( WOMAC ) , University of California Los Angeles ( UCLA ) activity , and Harris hip scores were obtained preoperatively , postoperatively , at six months , and annually thereafter .


All patients had significant improvement ( p < 0.05 ) in Short Form-36 Physical Component Summary , WOMAC , UCLA activity , and Harris hip scores postoperatively .


On radiostereometric analysis examination , highly cross-linked polyethylene liners showed significantly less median femoral head penetration at five years ( p < 0.05 ) .


Steady-state wear rates from one year to five years were 0.04 mm per year for ultra-high molecular weight polyethylene liners and 0.004 mm per year for highly cross-linked polyethylene liners .


At the five-year follow-up , the median migration ( and standard error ) was 0.05 0.20 mm proximally for titanium cups and 0.21 0.05 mm for tantalum cups .


In this young population who had undergone total hip replacement , radiostereometric analysis showed significantly less femoral head penetration in the highly cross-linked polyethylene liners compared with that in the conventional ultra-high molecular weight polyethylene liners .


Penetration rates were one order of magnitude less in highly cross-linked polyethylene liners compared with ultra-high molecular weight polyethylene liners .


There was no significant difference in proximal migration between the tantalum and titanium acetabular cups through the five-year follow-up ( p > 0.19 ) .


Inactivity and sedentary behavior are related to poorer health outcomes in breast cancer survivors .


However , few studies examining these behaviors in survivors have used objective measures , considered activities other than moderate-to-vigorous intensity activity ( MVPA ) and/or sedentary behavior ( i.e. low intensity activities ) or compared survivors to healthy controls .


The purpose of the present study is to compare accelerometer-measured activity of various intensities ( total , light , lifestyle , MVPA ) and sedentary behavior between breast cancer survivors and non-cancer controls .


An imputation-based approach of independent sample t-tests adjusting for multiple comparisons was used to compare estimates of participation in each activity and sedentary behavior between survivors [ n = 398 ; M ( SD ) age = 56.95 ( 9.11 ) ] and block-matched non-cancer controls [ n = 1120 ; M ( SD ) age = 54.88 ( 16.11 ) ] .


Potential moderating effects of body mass index ( BMI ) , age , and education were also examined .


Breast cancer survivors registered less daily total ( 282.8 v. 346.9 ) light ( 199.1 v. 259.3 ) and lifestyle ( 62.0 v. 71.7 ) activity minutes and more MVPA ( 21.6 v. 15.9 ) and sedentary behavior ( 555.7 v. 500.6 ) minutes than controls ( p < 0.001 for all ) .


These relationships were largely consistent across BMI , age and education .


On average , survivors spent an estimated 66.4 % of their waking time sedentary and 31.1 % in light/lifestyle activity and 2.6 % in MVPA .


Breast cancer survivors are more sedentary and participate in less low intensity activity than controls .


Although survivors registered more MVPA , these levels were insufficient .


Future research should explore these differences and potential benefits of targeting low intensity activities and reducing sedentary time in this population .


Scarring represents a significant biomedical burden in clinical medicine .


Mechanomodulation has been linked to scarring through inflammation , but until now a systematic approach to attenuate mechanical force and reduce scarring has not been possible .


The authors conducted a 12-month , prospective , open-label , randomized , multicenter clinical trial to evaluate abdominoplasty scar appearance following postoperative treatment with the embrace Advanced Scar Therapy device to reduce mechanical forces on healing surgical incisions .


Incisions from 65 healthy adult subjects were randomized to receive embrace treatment on one half of an abdominoplasty incision and control treatment ( surgeon 's optimal care methods ) on the other half .


The primary endpoint for this study was the difference between assessments of scar appearance for the treated and control sides using the visual analogue scale scar score .


Final 12-month study photographs were obtained from 36 subjects who completed at least 5 weeks of dressing application .


The mean visual analogue scale score for embrace-treated scars ( 2.90 ) was significantly improved compared with control-treated scars ( 3.29 ) at 12 months ( difference , 0.39 ; 95 percent confidence interval , 0.14 to 0.66 ; p = 0.027 ) .


Both subjects and investigators found that embrace-treated scars demonstrated significant improvements in overall appearance at 12 months using the Patient and Observer Scar Assessment Scale evaluation ( p = 0.02 and p < 0.001 , respectively ) .


No serious adverse events were reported .


These results demonstrate that the embrace device significantly reduces scarring following abdominoplasty surgery .


To the authors ' knowledge , this represents the first level I evidence for postoperative scar reduction .


Therapeutic , II .


Peritoneal dialysis ( PD ) requires patients to take an active role in their adherence to fluid restrictions .


Although fluid non-adherence had been identified among this patient group , no specific interventions have been researched or published with in the PD population .


The current study sought to investigate whether an applied cognitive behavioural therapy ( CBT-based intervention ) used among haemodialysis patients would improve fluid adherence among PD patients ; utilizing clinical indicators used in practice .


Fifteen PD patients identified as fluid non-adherent were randomly assigned to an intervention group ( IG ) or a deferred-entry control group ( CG ) .


The study ran for a total of 21 weeks , with five data collection points ; at baseline , post-intervention and at three follow-up points ; providing a RCT phase and a combined longitudinal analysis phase .


The content of the group intervention encompassed educational , cognitive and behavioural components , aimed to assist patients ' self-management of fluid .


No significant differences in weight ( kg ) reduction were found in either phase and undesirable changes in blood pressure ( BP ) were observed .


However , in the longitudinal phase , a statistically significant difference in oedematous status was observed at 6-week follow-up ; which may be indicative of fluid adherence .


Positive and significant differences were observed in the desired direction for measures of psychological well-being , quality of life and health beliefs ; areas correlated with enhanced fluid adherence in other research .


This study reveals encouraging and significant changes in predictors of fluid adherence .


Although there were no significant changes in weight as a crude clinical measure of fluid intake , significant reductions in oedematous status were observed as a consequence of this CBT-based group intervention .


This study compared palonosetron and ondansetron as rescue medications for postoperative nausea and vomiting ( PONV ) in patients who received prophylactic ondansetron .


Although guidelines recommend use of an agent from a different class when prophylaxis has failed , palonosetron has unique properties relative to other serotonin 5-HT3 receptor antagonists .


Prior trials assessing its use for rescue have had conflicting results .


Although palonosetron has compared favorably with ondansetron for PONV prevention , the drugs have not been compared in the rescue setting of failure of 5-HT3 receptor antagonist prophylaxis .


This was a randomized , open-label , multicenter trial comparing the efficacy and safety of intravenous palonosetron 0.075 mg and intravenous ondansetron 4mg in patients experiencing PONV following laparoscopic abdominal or gynecological surgery despite prophylactic ondansetron .


Of 239 patients screened , 220 were enrolled and 98 were treated for PONV : 48 and 50 in the palonosetron and ondansetron arms , respectively .


Complete control during 72hours after study drug administration was achieved in 25.0 % of palonosetron recipients and 18.0 % of ondansetron recipients ( 95 % confidence interval [ CI ] , -9.2 , 23.3 ; p = 0.40 ) .


Corresponding incidences of vomiting were 29.2 % for palonosetron and 48.0 % for ondansetron ( 95 % CI , -0.06 , 37.7 ; p = 0.057 ) , and 62.5 % and 56.0 % required additional rescue treatment , respectively ( 95 % CI , -25.9 , 12.9 ; p = 0.52 ) .


Other than a similar incidence of procedural pain in the 2 groups , the most common treatment-emergent adverse events , which were generally mild , were headache ( 14.6 % vs 12.0 % ) , constipation ( 8.3 % vs 10.0 % ) , and dizziness ( 6.3 % vs 8.0 % ) , for the palonosetron and ondansetron groups , respectively .


Palonosetron and ondansetron did not show differences in the primary efficacy endpoint of CC during the 72hours after study drug administration .


There was a trend toward less emesis in the 0-72h time period favoring palonosetron .


While larger studies are needed to fully assess any clinical benefits of palonosetron to rescue patients who have failed ondansetron prophylaxis for PONV , the benefit , if any , would be limited based on this study .


ClinicalTrials.gov , NCT00967499 ( Registered August 27 , 2009 ) .


Current methods of the transtibial pull-out meniscal root repair significantly displace under cyclic loading in porcine models but have not been evaluated in human models .


One potential explanation for the displacement is that a single transtibial tunnel may not fully restore the attachment of the entire posterior medial meniscal root .


The purpose of this study was to biomechanically evaluate the transtibial pull-out technique in a human cadaveric model using either 1 or 2 transtibial bone tunnels .


The hypothesis was that a transtibial pull-out technique using 2 transtibial bone tunnels would confer superior biomechanical properties in comparison to an iteration using 1 transtibial bone tunnel .


Controlled laboratory study .


Ten matched pairs of male human cadaveric knees ( average age , 52.7 years ) were randomly assigned ( 1 each of the pair ) to 2 groups consisting of a transtibial pull-out technique using either 1 or 2 transtibial bone tunnels .


The knees were cyclically loaded for 1000 cycles from 10 to 30 N at 0.5 Hz , representing the loads experienced during a typical meniscal root repair postoperative rehabilitation program , and then pulled to failure at a rate of 0.5 mm/s .


Differences between 1 - and 2-tunnel repair groups were neither statistically nor clinically significant with respect to displacement or ultimate failure load .


On average , the 1 - and 2-tunnel repair groups resulted in 3.32 mm and 3.23 mm of displacement , respectively , after 1000 testing cycles .


At 1 , 100 , 500 , and 1000 testing cycles , displacement was not significantly different between groups ( P > .799 ) .


The 2-tunnel repair technique resulted in a 10.2 % higher ultimate failure load ( 135 N vs. 123 N ) ; however , this was not significant ( P = .333 ) .


Similar biomechanical properties were seen between transtibial pull-out repairs using either 1 or 2 transtibial bone tunnels in a human cadaveric model .


Both repair groups exceeded the 3-mm threshold for nonanatomic displacement .


This study indicates that a newly proposed iteration of the transtibial pull-out repair technique using a second transtibial tunnel , which theoretically restores more of the posterior medial meniscal root , was almost identical to the current clinical standard involving a single transtibial tunnel .


As the importance of repairing meniscal root tears is increasingly recognized , further studies on new iterations of both techniques are warranted to minimize the risk of displacement caused by early motion in the initial postoperative rehabilitation period .


Several evidence-based treatments are available to veterans diagnosed with posttraumatic stress disorder ( PTSD ) .


However , not all veterans benefit from these treatments or prefer to engage in them .


The current study explored whether ( 1 ) a mantram repetition program ( MRP ) increased mindful attention among veterans with PTSD , ( 2 ) mindful attention mediated reduced PTSD symptom severity and enhanced psychological well-being , and ( 3 ) improvement in mindful attention was due to the frequency of mantram repetition practice .


Data from a randomized controlled trial comparing MRP plus treatment as usual ( MRP+TAU ) or TAU were analyzed using hierarchical linear models .


A total of 146 veterans with PTSD from military-related trauma were recruited from a Veterans Affairs outpatient PTSD clinic ( 71 MRP+TAU ; 75 TAU ) .


The Clinician Administered PTSD Scale ( CAPS ) , PTSD Checklist ( PCL ) , the Brief Symptom Inventory-18 depression subscale , Health Survey SF-12v2 , and Mindfulness Attention Awareness Scale ( MAAS ) were used .


Frequency of mantram repetition practice was measured using wrist-worn counters and daily logs .


Intent-to-treat analyses indicated greater increases in mindful attention , as measured by the MAAS , for MRP+TAU as compared with TAU participants ( P < 0.01 ) .


Mindful attention gains mediated previously reported treatment effects on reduced PTSD symptoms ( using both CAPS and PCL ) , reduced depression , and improved psychological well-being .


Frequency of mantram repetition practice in turn mediated increased mindful attention .


The MRP intervention and specifically , mantram practice , improved mindful attention in veterans with PTSD , yielding improved overall psychological well-being .


MRP may be a beneficial adjunct to usual care in veterans with PTSD .


ODM-201 is a novel androgen receptor ( AR ) inhibitor designed to block the growth of prostate cancer cells through high-affinity binding to the AR and inhibition of AR nuclear translocation .


This trial assessed ODM-201 's safety , pharmacokinetics , and activity in men with metastatic castration-resistant prostate cancer .


The ARADES trial is an open-label phase 1-2 trial undertaken in 23 hospitals across Europe and USA with ongoing long-term follow-up .


Men with progressive metastatic castration-resistant prostate cancer , who had castrate concentrations of testosterone and an Eastern Cooperative Oncology Group score of 0-1 were enrolled .


In the phase 1 part of the trial , patients were given oral ODM-201 at a starting daily dose of 200 mg , which was increased to 400 mg , 600 mg , 1000 mg , 1400 mg , and 1800 mg .


In phase 2 , patients were randomly assigned centrally and stratified by previous chemotherapy and treatment with CPY17 inhibitors , to receive one of three daily doses of ODM-201 ( 200 mg , 400 mg , and 1400 mg ) .


The primary endpoint in phase 1 was safety and tolerability , whereas in phase 2 it was the proportion of patients with a PSA response ( 50 % or greater decrease in serum PSA ) at week 12 .


All analyses included patients who had received at least one dose of ODM-201 .


This trial is registered with ClinicalTrials.gov , number NCT01317641 , and NCT01429064 for the follow-up after 12 weeks .


We enrolled patients between April 5 , 2011 , and March 12 , 2013 .


In phase 1 , 24 patients were enrolled to six sequential cohorts of three to six patients and received a daily dose of ODM-201 , 200-1800 mg .


No dose-limiting toxic effects were reported and the maximum tolerated dose was not reached .


In phase 1 , three patients reported eight adverse events of grade 3 ( fracture , muscle injury , laceration , paralytic ileus , pain , presyncope , urinary retention , and vomiting ) and one patient had a grade 4 adverse event ( lymphoedema ) .


None of the grade 3-4 adverse events were deemed to be related to ODM-201 .


Of the phase 1 patients , the four who received 200 mg , seven who received 400 mg , and three who received 1400 mg entered the phase 2 part of the trial .


In addition to these patients , 110 were randomly assigned to three groups : 200 mg ( n = 38 ) , 400 mg ( n = 37 ) , and 1400 mg ( n = 35 ) .


For these patients , the most common treatment-emergent adverse events were fatigue or asthenia ( 15 [ 12 % ] of 124 patients ) , hot flush ( six [ 5 % ] ) , and decreased appetite ( five [ 4 % ] ) .


One patient ( < 1 % ) had a grade 3 treatment-emergent adverse event ( fatigue ) ; no patients had a treatment-emergent grade 4 adverse event .


38 patients who received 200 mg , 39 who received 400 mg , and 33 who received 1400 mg were assessable for PSA response at 12 weeks .


11 ( 29 % ) patients in the 200 mg group , 13 ( 33 % ) in the 400 mg group , and 11 ( 33 % ) in the 1400 mg group had a PSA response at 12 weeks .


Our results suggest that ODM-201 monotherapy in men with progressive metastatic castration-resistant prostate cancer provides disease suppression and that ODM-201 has a favourable safety profile .


These findings support further investigation of clinical responses with ODM-201 in men with castration-resistant prostate cancer .


Orion Corporation Orion Pharma , Endo Pharmaceuticals Inc. .


The United Kingdom Employment Retention and Advancement ( U.K. ERA ) demonstration was the largest and most comprehensive social experiment ever conducted in the United Kingdom .


It examined the extent to which a combination of postemployment advisory support and financial incentives could help lone parents on welfare to find sustained employment with prospects for advancement .


ERA was experimentally tested across more than 50 public employment service offices and , within each office , individuals were randomly assigned to either a program ( or treatment ) group ( eligible for ERA ) or a control group ( not eligible ) .


This article presents the results of a multilevel nonexperimental analysis that examines the variation in office-level impacts and attempts to understand what services provided in the offices tend to be associated with impacts .


The analysis suggests that impacts were greater in offices that emphasized in-work advancement , support while working and financial bonuses for sustained employment , and also in those offices that assigned more caseworkers to ERA participants .


Offices that encouraged further education had smaller employment impacts .


Plausible results are obtained identifying those particular implementation features that tended to be linked to stronger impacts of ERA .


The methodology employed also allows the identification of which services are associated with employment and welfare receipt of control families receiving benefits under the traditional New Deal for Lone Parent program .


Minimally invasive surgeries of the soft palate have emerged as a less-invasive treatment for habitual snoring .


To date , there is only limited information available comparing the effects of snoring sound between different minimally invasive surgeries in the treatment of habitual snoring .


To compare the efficacy of palatal implant and radiofrequency surgery , in the reduction of snoring through subjective evaluation of snoring and objective snoring sound analysis .


Thirty patients with habitual snoring due to palatal obstruction ( apnea-hypopnea index 15 , body max index 30 ) were prospectively enrolled and randomized to undergo a single session of palatal implant or temperature-controlled radiofrequency surgery of the soft palate under local anesthesia .


Snoring was primarily evaluated by the patient with a 10 cm visual analogue scale ( VAS ) at baseline and at a 3-month follow-up visit and the change in VAS was the primary outcome .


Moreover , life qualities , measured by snore outcomes survey , and full-night snoring sounds , analyzed by a sound analytic program ( Snore Map ) , were also investigated at the same time .


Twenty-eight patients completed the study ; 14 received palatal implant surgery and 14 underwent radiofrequency surgery .


The VAS and snore outcomes survey scores were significantly improved in both groups .


However , the good response ( postoperative VAS 3 or postoperative VAS 5 plus snore outcomes survey score 60 ) rate of the palatal implant group was significantly higher than that of the radiofrequency group ( 79 % vs. 29 % , P = 0.021 ) .


The maximal loudness of low-frequency ( 40-300 Hz ) snores was reduced significantly in the palatal implant group .


In addition , the snoring index was significantly reduced in the radiofrequency group .


Both palatal implants and a single-stage radiofrequency surgery improve subjective snoring outcomes , but palatal implants have a greater effect on most measures of subjective and objective snoring .


Multi-stage radiofrequency surgery was not tested .


ClinicalTrials.gov NCT01955083 .


To investigate whether a maneuver for repeated cycles of collapse and reexpansion of the operative lung , termed `` intermittent reinflation '' ( IR ) , to counter hypoxemia during one-lung ventilation ( OLV ) , results in a time-dependent alteration of extravascular lung water .


Prospective , randomized clinical study .


Operating room and postsurgical intensive care unit of a university hospital .


36 ASA physical status 1 and 2 patients undergoing elective , video-assisted thoracic surgery for lung tumors .


Patients were randomly assigned to two groups .


Group C consisted of 18 patients whose nondependent lung was kept collapsed during OLV , while Group IR included 18 patients with IR that consisted of 4 separate , 10-second manual inflations and 5-second openings within one minute at intervals of 20 minutes during OLV .


Perioperative parameters included transcutaneous oxygen saturation ( SpO2 ) , hemodynamic data , extravascular lung water index ( EVLWI ) , pulmonary vascular permeability index ( PVPI ) as determined by the single-indicator transpulmonary thermodilution technique , and partial pressure of arterial oxygen/inspired oxygen fraction ( PaO2/FIO2 ) ratio .


Group IR had significantly higher SpO2 at 20 minutes after commencement of OLV ( 98.9 % vs 96.3 % , P = 0.029 ) and average SpO2 throughout OLV ( 98.7 % vs 97.0 % , P = 0.020 ) .


Hemodynamic data , EVLWI , PVPI , and PaO2/FIO2 ratio did not differ between the groups , and there were no differences between groups in postoperative morbidity or hospital stay .


Intermittent reinflation had a beneficial effect on oxygenation during OLV , without any significant effects on EVLW or postoperative outcomes .


To report and discuss the multi-domain impact of elosulfase alfa , with focus on tertiary and composite endpoints , in the 24-week , randomized , double-blind , placebo-controlled phase 3 trial in patients with Morquio A syndrome ( mucopolysaccharidosis IVA ) .


Patients with Morquio A syndrome aged 5 years were randomized 1:1:1 to elosulfase alfa 2.0 mg/kg/week ( qw ; N = 58 ) , elosulfase alfa 2.0 mg/kg/every other week ( qow ; N = 59 ) , or placebo ( N = 59 ) for 24 weeks .


Primary and secondary efficacy measures were 6-minute walk test ( 6MWT ; primary ) , 3-minute stair climb test ( 3-MSCT ) and urinary keratan sulfate ( KS ) .


Safety was also evaluated .


Tertiary efficacy measures included respiratory function measures , activities of daily living ( MPS Health Assessment Questionnaire [ MPS-HAQ ] ) , anthropometric , echocardiographic and radiographic measures , hearing and corneal clouding assessment .


In order to fully characterize treatment impact in this heterogeneous disorder , the effect of elosulfase alfa on composite efficacy measures was evaluated as well .


The study was not designed to have sufficient power for any of the tertiary outcomes .


For most tertiary endpoints , subjects treated with the weekly dose of elosulfase alfa improved more than those receiving placebo .


The largest treatment effects were seen in maximal voluntary ventilation ( MVV ) , MPS-HAQ , height , and growth rate .


The qow group appeared similar to placebo .


The analysis of a pre-specified composite endpoint ( combining changes from baseline in 6MWT , 3MSCT and MVV z-scores equally weighted ) showed a modest positive impact of elosulfase alfa qw versus placebo group ( P = 0.053 ) .


As a pre-specified supportive analysis , the O'Brien Rank Sum composite endpoint ( changes from baseline in 6MWT , 3MSC , and MVV ) , analysis also showed that the qw group performed better than the placebo group ( P = 0.011 ) .


In post-hoc analyses , combinations of other endpoints were also explored using the O'Brien Rank Sum test and showed statistically significant differences between elosulfase alfa qw and placebo favoring elosulfase alfa qw .


Differences between elosulfase alfa qow and placebo were not statistically significant .


Positive changes were observed in most tertiary variables , demonstrating the efficacy of weekly treatment with elosulfase alfa .


Treatment with weekly elosulfase alfa led to improvements across most efficacy measures , resulting in clinically meaningful benefits in a heterogeneous study population .


Acute myocardial infarction ( AMI ) is the leading cause of mortality worldwide .


Oxidative stress has been involved in the ischemia-reperfusion injury in AMI .


It has been suggested that reperfusion accounts for up to 50 % of the final size of a myocardial infarct , a part of the damage likely to be prevented.Therefore , we propose that antioxidant reinforcement through vitamins C and E supplementation should protect against the ischemia-reperfusion damage , thus decreasing infarct size.The PREVEC Trial ( Prevention of reperfusion damage associated with percutaneous coronary angioplasty following acute myocardial infarction ) seeks to evaluate whether antioxidant vitamins C and E reduce infarct size in patients subjected to percutaneous coronary angioplasty after AMI .


This is a randomized , 1:1 , double-blind , placebo-controlled clinical trial.The study takes place at two centers in Chile : University of Chile Clinical Hospital and San Borja Arriarn Clinical Hospital.The subjects will be 134 adults with acute myocardial infarction with indication for percutaneous coronary angioplasty.This intervention is being performed as a pilot study , involving high-dose vitamin C infusion plus oral administration of vitamin E ( Vitamin-treatment group ) or placebo ( Control group ) during the angioplasty procedure .


Afterward , the Vitamin-treatment group receives oral doses of vitamins C and E , and the Control group receives placebo for 84 days after coronary angioplasty.Primary outcome is infarct size , assessed by cardiac magnetic resonance ( CMR ) , measured 6 and 84 days after coronary angioplasty.Secondary outcomes are ejection fraction , measured 6 and 84 days after coronary angioplasty with CMR , and biomarkers for oxidative stress , antioxidant status , heart damage , and inflammation , which will be measured at baseline , at the onset of reperfusion , 6 to 8 hours after revascularization , and at hospital discharge .


The ischemia-reperfusion event occurring during angioplasty is known to increase myocardial infarct size .


The cardioprotective benefits of high doses of vitamin C combined with vitamin E have not been fully explored .


The PREVEC Trial seeks to determine the suitability of the therapeutic use of vitamins C and E against the reperfusion damage produced during angioplasty.Patient recruitment opened in February 2013 .


The trial is scheduled to end in March 2016 .


ISRCTN56034553 .


To evaluate the safety and efficacy of dexamethasone intravitreal implant ( Ozurdex , DEX implant ) 0.7 and 0.35 mg in the treatment of patients with diabetic macular edema ( DME ) .


Two randomized , multicenter , masked , sham-controlled , phase III clinical trials with identical protocols were conducted .


Data were pooled for analysis .


Patients ( n = 1048 ) with DME , best-corrected visual acuity ( BCVA ) of 20/50 to 20/200 Snellen equivalent , and central retinal thickness ( CRT ) of 300 m by optical coherence tomography .


Patients were randomized in a 1:1:1 ratio to study treatment with DEX implant 0.7 mg , DEX implant 0.35 mg , or sham procedure and followed for 3 years ( or 39 months for patients treated at month 36 ) at 40 scheduled visits .


Patients who met retreatment eligibility criteria could be retreated no more often than every 6 months .


The predefined primary efficacy endpoint for the United States Food and Drug Administration was achievement of 15-letter improvement in BCVA from baseline at study end .


Safety measures included adverse events and intraocular pressure ( IOP ) .


Mean number of treatments received over 3 years was 4.1 , 4.4 , and 3.3 with DEX implant 0.7 mg , DEX implant 0.35 mg , and sham , respectively .


The percentage of patients with 15-letter improvement in BCVA from baseline at study end was greater with DEX implant 0.7 mg ( 22.2 % ) and DEX implant 0.35 mg ( 18.4 % ) than sham ( 12.0 % ; P 0.018 ) .


Mean average reduction in CRT from baseline was greater with DEX implant 0.7 mg ( -111.6 m ) and DEX implant 0.35 mg ( -107.9 m ) than sham ( -41.9 m ; P < 0.001 ) .


Rates of cataract-related adverse events in phakic eyes were 67.9 % , 64.1 % , and 20.4 % in the DEX implant 0.7 mg , DEX implant 0.35 mg , and sham groups , respectively .


Increases in IOP were usually controlled with medication or no therapy ; only 2 patients ( 0.6 % ) in the DEX implant 0.7 mg group and 1 ( 0.3 % ) in the DEX implant 0.35 mg group required trabeculectomy .


The DEX implant 0.7 mg and 0.35 mg met the primary efficacy endpoint for improvement in BCVA .


The safety profile was acceptable and consistent with previous reports .


To explore the effects of early intervention of acupuncture on urinary function reconstruction of neurogenic bladder after spinal cord injury , so as to find the optimal treatment timing of acupuncture .


Fifty-three patients of neurogenic bladder after spinal cord injury were randomly divided into a prior-to-catheter group ( 25 cases ) and a posterior-to-catheter group ( 28 cases ) .


For the prior-to-catheter group , one week before the removal of catheter , acupoints on the abdomen and back such as Guanyuan ( CV 4 ) , Zhongji ( CV 3 ) , Baliao ( Shangliao ( BL 31 ) , Ciliao ( BL 32 ) , Zhongliao ( BL 33 ) , Xialiao ( BL 34 ) , Jiaji ( EX-B 2 ) and acupoints at distal end such as Zusanli ( ST 36 ) and Sanyinjiao ( SP 6 ) were selected ; after the catheter removal , simple method .


of water column was used to measure bladder capacity pressure to classify the type of bladder , and then different acupuncture manipulations were given ; intermittent catheterization was performed if condition was allowed .


The posterior-to-catheter group applied identical treatment after removal of catheter as the prior-to-catheter group .


The treatment was given 5 times per week ; after one-month treatment , five aspects including the time of first effective urination , time of establishing reflex urination , average residual volume of urine , time of residual urine less than 100 mL and quality of life ( QOL ) were evaluated .


After treatment , the time of first effective urination , time of establishing reflex urination , average residual volume of urine and time of residual urineless than 100 mL in the prior-to-catheter group were all superior to those in the posterior-to-catheter group ( all P < 0.05 ) ; the score of QOL was improved in two groups after treatment ( both P < 0.01 ) , but the difference between two groups was not statistically significant ( P > 0.05 ) ; each index of urination function was not significant among patients with different injured segments of spinal cord ( all P > 0.05 ) .


The early intervention of acupuncture ( prior to catheter ) has obvious improving function on establishing balanced bladder in patients with neurogenic bladder after spinal cord injury , which is superior to acupuncture intervention after removal of catheter , however , the effects of different injured segments on establishing balanced bladder are not different .


To identify a group of deliveries to mothers with indicators of subfertility ( SUBFERTILITY ) .


Longitudinal cohort study .


Hospital .


A total of 334,152 deliveries to Massachusetts mothers in a Massachusetts hospital between July 1 , 2004 , and December 31 , 2008 .


None .


Subfertility was defined by an indication on a current or past birth certificate or hospital utilization data of infertility or assisted reproductive technology ( ART ) cycle before index delivery and no indication of ART use with index delivery .


Initially , 12,367 deliveries met the inclusion criteria for SUBFERTILITY ( 8,019 from birth certificates , 2,777 from hospital data , 1,571 from prior ART treatment ) .


Removing deliveries from more than one data source resulted in 10,764 unique deliveries .


Removing deliveries resulting from ART treatments left 6,238 deliveries in the SUBFERTILITY category .


Demographic analysis indicated that deliveries in SUBFERTILITY were more similar to those in the ART population than to those in the fertile population .


We have demonstrated the feasibility of using existing population-based linked public health data sets to identify SUBFERTILITY deliveries , and we have used ART data to distinguish ART and SUBFERTILITY births .


The SUBFERTILITY category can serve as a comparison group of subfertile patients for studies of ART delivery and longitudinal health outcomes .


Idrabiotaparinux , a long-acting inhibitor of factor Xa , was shown to be effective in the treatment of patients with venous thromboembolism .


To assess non-inferiority for the efficacy of idrabiotaparinux versus warfarin in patients with atrial fibrillation ( AF ) at risk of stroke and systemic embolism .


Bleeding was also assessed .


This randomized , double-blind trial enrolled patients with electrocardiogram-documented AF .


Idrabiotaparinux was administered weekly via subcutaneous injection , and warfarin was administered daily with dose adjustment to maintain the international normalized ratio between 2.0 and 3.0 .


Each idrabiotaparinux injection was 3 mg for the first 7 weeks , followed by 2 mg thereafter , except in patients with a creatinine clearance of 30-50 mL min ( -1 ) or aged 75 years .


The patients received 1.5 mg after the first 7 weeks .


The efficacy outcome was the composite of all fatal or non-fatal strokes and systemic embolism .


The safety outcome was clinically relevant bleeding ( major and clinically relevant non-major bleeding ) .


The study was terminated prematurely by the sponsor for strategic/commercial , not scientific , reasons , with 39 % of the planned number of patients included and an average duration of treatment of 240 days .


Of the 1886 idrabiotaparinux recipients , 20 developed stroke or systemic embolism ( 1.5 % per year ) , whereas this occurred in 22 of the 1887 warfarin patients ( 1.6 % per year , hazard ratio 0.98 , 95 % confidence interval 0.49-1 .66 ) .


The annual incidence of bleeding was 6.1 % in the idrabiotaparinux and 10.0 % in the warfarin group ( hazard ratio 0.61 , 95 % confidence interval 0.46-0 .81 ) .


If anything , despite its early termination , the idrabiotaparinux regimen studied suggested a comparable efficacy to dose-adjusted warfarin , with a lower bleeding risk .


Low rates of adherence to artemisinin-based combination therapy ( ACT ) regimens increase the risk of treatment failure and may lead to drug resistance , threatening the sustainability of current anti-malarial efforts .


We assessed the impact of text message reminders on adherence to ACT regimens .


Health workers at hospitals , clinics , pharmacies , and other stationary ACT distributors in Tamale , Ghana provided flyers advertising free mobile health information to individuals receiving malaria treatment .


The messaging system automatically randomized self-enrolled individuals to the control group or the treatment group with equal probability ; those in the treatment group were further randomly assigned to receive a simple text message reminder or the simple reminder plus an additional statement about adherence in 12-hour intervals .


The main outcome was self-reported adherence based on follow-up interviews occurring three days after treatment initiation .


We estimated the impact of the messages on treatment completion using logistic regression .


1140 individuals enrolled in both the study and the text reminder system .


Among individuals in the control group , 61.5 % took the full course of treatment .


The simple text message reminders increased the odds of adherence ( adjusted OR 1.45 , 95 % CI [ 1.03 to 2.04 ] , p-value 0.028 ) .


Receiving an additional message did not result in a significant change in adherence ( adjusted OR 0.77 , 95 % CI [ 0.50 to 1.20 ] , p-value 0.252 ) .


The results of this study suggest that a simple text message reminder can increase adherence to antimalarial treatment and that additional information included in messages does not have a significant impact on completion of ACT treatment .


Further research is needed to develop the most effective text message content and frequency .


ClinicalTrials.gov NCT01722734 .


We sought to define normative visual field ( VF ) values for children using common clinical test protocols for kinetic and static perimetry .


Prospective , observational study .


We recruited 154 children aged 5 to 15 years without any ophthalmic condition that would affect the VF ( controls ) from pediatric clinics at Moorfields Eye Hospital .


Children performed perimetric assessments in a randomized order using Goldmann and Octopus kinetic perimetry , and Humphrey static perimetry ( Swedish Interactive Thresholding Algorithm [ SITA ] 24-2 FAST ) , in a single sitting , using standardized clinical protocols , with assessment by a single examiner .


Unreliable results ( assessed qualitatively ) were excluded from the normative data analysis .


Linear , piecewise , and quantile mixed-effects regression models were used .


We developed a method to display age-specific normative isopters graphically on a VF plot to aid interpretation .


Summary measures and graphical plots describing normative VF data for 3 common perimetric tests .


Visual field area increased with age on testing with Goldmann isopters III4e , I4e , and I2e ( linear regression ; P < 0.001 ) and for Octopus isopters III4e and I4e ( linear regression ; P < 0.005 ) .


Visual field development occurs predominately in the inferotemporal field .


Humphrey mean deviation ( MD ) showed an increase of 0.3 decibels ( dB ; 95 % CI , 0.21-0 .40 ) MD per year up to 12 years of age , when adult MD values were reached and thereafter maintained .


Visual field size and sensitivity increase with age in patterns that are specific to the perimetric approach used .


These developmental changes should be accounted for when interpreting perimetric test results in children , particularly when monitoring change over time .


Guidelines for SPECT myocardial perfusion imaging ( MPI ) traditionally recommend a fixed tracer dose .


Yet , clinical practice shows degraded image quality in heavier patients .


The aim was to optimize and validate the tracer dose and scan time to obtain a constant image quality less dependent on patients ' physical characteristics .


125 patients underwent Cadmium Zinc Telluride ( CZT ) - SPECT stress MPI using a fixed Tc-99m-tetrofosmin tracer dose .


Image quality was scored by three physicians on a 4-point grading scale and related to the number of photon counts normalized to tracer dose and scan time .


Counts were correlated with various patient-specific parameters dealing with patient size and weight to find the best predicting parameter .


From these data , a formula to provide constant image quality was derived , and subsequently tested in 92 new patients .


Degradation in image quality and photon counts was observed for heavier patients for all patients ' specific parameters ( P < .01 ) .


We found body weight to be the best-predicting parameter for image quality and derived a new dose formula .


After applying this new body weight-depended tracer dose and scan time in a new group , image quality was found to be constant ( P > .19 ) in all patients .


Also in CZT SPECT image quality decreases with weight .


The use of a tracer dose and scan time that depends linearly on patient 's body weight corrected for the varying image quality in CZT-SPECT MPI .


This leads to better radiation exposure justification .


No randomised study has shown whether stratification of treatment by minimal residual disease ( MRD ) response improves outcome in children and young people with acute lymphoblastic leukaemia ( ALL ) .


We assessed whether children and young people with clinical standard and intermediate-risk ALL who have persistent MRD at the end of induction therapy benefit from augmented post-remission therapy .


Between Oct 1 , 2003 , and June 30 , 2011 , we enrolled eligible patients aged 1-24 years and initially categorised them into clinical standard-risk , intermediate-risk , and high-risk groups on the basis of a combination of National Cancer Institute criteria , cytogenetics , and early morphological response to induction therapy .


Clinical standard-risk and intermediate-risk patients with MRD of 001 % or higher at day 29 of induction ( MRD high risk ) were randomly assigned ( 1:1 ) to standard therapy ( treatment regimens A and B ) or augmented post-remission therapy ( regimen C ) .


Compared with standard therapy , the augmented treatment regimen ( regimen C ) included an additional eight doses of pegylated asparaginase , 18 doses of vincristine , and escalated-dose intravenous methotrexate without folinic acid rescue during interim maintenance courses .


Computer randomisation was used for treatment allocation and was balanced for sex , age ( < 10 years vs 10 years ) , and white blood cell count at diagnosis ( < 5010 ( 9 ) / L vs 5010 ( 9 ) / L ) by minimisation .


Patients , clinicians , and data analysts were not masked to treatment allocation .


The primary outcomes were event-free survival and overall survival .


Analyses were by intention to treat .


This trial is registered with Current Controlled Trials , number ISRCTN07355119 .


533 MRD high-risk patients were randomly assigned to receive standard ( n = 266 ) or augmented ( n = 267 ) post-remission therapy .


After a median follow-up of 70 months ( IQR 52-91 ) , 5-year event-free survival was better in the augmented treatment group ( 896 % [ 95 % CI 859-933 ] ) than in the standard group ( 828 % [ 781-875 ] ; odds ratio [ OR ] 061 [ 95 % CI 039-098 ] , p = 004 ) .


Overall survival at 5 years was numerically , but not significantly , higher in the augmented treatment group ( 929 % [ 95 % CI 898-960 ] ) than in the standard therapy group ( 889 % [ 850-928 ] ; OR 067 [ 95 % CI 038-117 ] , p = 016 ) .


More adverse events occurred in the augmented treatment group than in the standard group ( asparaginase-related hypersensitivity in 18 [ 67 % ] in the augmented group vs two [ 08 % ] in the standard group and asparaginase-related pancreatitis in eight [ 30 % ] vs one [ 04 % ] ; intravenous methotrexate-related mucositis in 11 [ 41 % ] vs three [ 11 % ] and methotrexate-related stomatitis in 48 [ 180 % ] vs 12 [ 45 % ] ) .


Our findings suggest that children and young people with acute lymphoblastic leukaemia and 001 % or more MRD at the end of remission induction therapy could benefit from augmented post-remission therapy .


However , the asparaginase and intravenous methotrexate used in the augmented treatment regimen is associated with more adverse events than is the standard post-remission treatment regimen .


Medical Research Council and Leukaemia and Lymphoma Research .


Quantification of molecular cell processes is important for prognostication and treatment individualization of head and neck cancer ( HNC ) .


However , individual tumor comparison can show discord in upregulation similarities when analyzing multiple biological mechanisms .


Elaborate tumor characterization , integrating multiple pathways reflecting intrinsic and microenvironmental properties , may be beneficial to group most uniform tumors for treatment modification schemes .


The goal of this study was to systematically analyze if immunohistochemical ( IHC ) assessment of molecular markers , involved in treatment resistance , and 18F-FDG PET parameters could accurately distinguish separate HNC tumors .


Several imaging parameters and texture features for 18F-FDG small-animal PET and immunohistochemical markers related to metabolism , hypoxia , proliferation and tumor blood perfusion were assessed within groups of BALB/c nu/nu mice xenografted with 14 human HNC models .


Classification methods were used to predict tumor line based on sets of parameters .


We found that 18F-FDG PET could not differentiate between the tumor lines .


On the contrary , combined IHC parameters could accurately allocate individual tumors to the correct model .


From 9 analyzed IHC parameters , a cluster of 6 random parameters already classified 70.3 % correctly .


Combining all PET/IHC characteristics resulted in the highest tumor line classification accuracy ( 81.0 % ; cross validation 82.0 % ) , which was just 2.2 % higher ( p = 5.210-32 ) than the performance of the IHC parameter/feature based model .


With a select set of IHC markers representing cellular processes of metabolism , proliferation , hypoxia and perfusion , one can reliably distinguish between HNC tumor lines .


Addition of 18F-FDG PET improves classification accuracy of IHC to a significant yet minor degree .


These results may form a basis for development of tumor characterization models for treatment allocation purposes .


The EACH study assessed the efficacy of oxaliplatin , 5-fluorouracil , and leucovorin ( the FOLFOX4 regimen ) compared with doxorubicin alone in terms of overall survival ( OS ) , progression-free survival ( PFS ) , and safety in patients with advanced hepatocellular carcinoma ( HCC ) .


We present the results of this study in Chinese patients .


In a multicenter , open-label , randomized , phase III study ( NCT00471965 ) , 371 patients ( 279 patients from the People 's Republic of China ) were randomized 1:1 to receive either FOLFOX4 or doxorubicin until disease progression , intolerable toxicity , death , or surgical resection .


Baseline characteristics of the Chinese patients enrolled in the study were similar for the 2 treatment groups and in comparison with the whole EACH cohort .


Median OS at the prespecified time point of treatment was 5.7 months with FOLFOX4 and 4.3 months with doxorubicin ( hazard ratio [ HR ] : 0.74 ; 95 % confidence interval [ CI ] :0.55 -0.98 ; p = .03 ) .


At the end of the follow-up period , median OS was 5.9 months with FOLFOX4 and 4.3 months with doxorubicin ( HR : 0.75 ; 95 % CI :0.58 -0.98 ; p = .03 ) .


Median PFS was 2.4 months and 1.7 months in the FOLFOX4 and doxorubicin groups , respectively ( HR : 0.55 ; 95 % CI :0.45 -0.78 ; p = .0002 ) .


The response rate ( RR ) and disease control rate ( DCR ) were significantly higher in the FOLFOX4 group than in the doxorubicin group ( RR : 8.6 % vs. 1.4 % , p = .006 ; DCR : 47.1 % vs. 26.6 % , p = .0004 ) .


Hematological toxicity was more frequently reported in the FOLFOX4 group .


For Chinese HCC patients enrolled in the EACH study , FOLFOX4 significantly improved the RR and DCR and prolonged survival compared with doxorubicin .


Systemic chemotherapy with oxaliplatin-based regimens may play an important role in the treatment of Chinese patients with advanced HCC .


Children are vulnerable to diet inadequacies , which may affect immune function .


Our objective was to determine if a follow-up formula ( FUF ) containing DHA , the prebiotics PDX and GOS , and yeast - glucan affects incidence of respiratory infections and diarrheal disease in healthy children .


In a double-blind , randomized , controlled , prospective trial , 3-4 year old children were fed 3 servings per day of either a FUF with 25 mg DHA , 1.2 g PDX/GOS , and 8.7 mg yeast - glucan per serving or an unfortified , cow 's milk-based beverage ( control ) for 28 weeks .


Fecal and blood samples were collected to assess immune markers and iron/zinc status .


Incidence of acute respiratory infections ( ARI ) , diarrheal disease , and antibiotic treatment were obtained from medical records .


The FUF group had fewer episodes and shorter duration of ARI ( mean days [ SE ] ; control = 4.3 [ 0.2 ] ; FUF = 3.5 [ 0.2 ] ; P = .007 ) , less antibiotic use ( n [ % ] ; control = 21 [ 14 % ] ; FUF = 8 [ 5 % ] ; P = .01 ) , and fewer missed days of day care due to illness .


No diarrheal disease was diagnosed in either group .


The FUF group had higher interleukin-10 and white blood cell count at the end of the study .


There were no differences in hemoglobin , serum ferritin and zinc , or fecal secretory immunoglobulin A.


Daily consumption of a FUF was associated with fewer episodes and shorter duration of ARI , as well as less antibiotic use .


The children who consumed the FUF had increased interleukin-10 and white blood cells , suggesting an antiinflammatory mechanism and/or an increase of effector immune cells .


In the PROTECT AF ( Watchman Left Atrial Appendage Closure Technology for Embolic Protection in Patients With Atrial Fibrillation ) trial that evaluated patients with nonvalvular atrial fibrillation ( NVAF ) , left atrial appendage ( LAA ) occlusion was noninferior to warfarin for stroke prevention , but a periprocedural safety hazard was identified .


The goal of this study was to assess the safety and efficacy of LAA occlusion for stroke prevention in patients with NVAF compared with long-term warfarin therapy .


This randomized trial further assessed the efficacy and safety of the Watchman device .


Patients with NVAF who had a CHADS2 ( congestive heart failure , hypertension , age > 75 years , diabetes mellitus , and previous stroke/transient ischemic attack ) score 2 or 1 and another risk factor were eligible .


Patients were randomly assigned ( in a 2:1 ratio ) to undergo LAA occlusion and subsequent discontinuation of warfarin ( intervention group , n = 269 ) or receive chronic warfarin therapy ( control group , n = 138 ) .


Two efficacy and 1 safety coprimary endpoints were assessed .


At 18 months , the rate of the first coprimary efficacy endpoint ( composite of stroke , systemic embolism [ SE ] , and cardiovascular/unexplained death ) was 0.064 in the device group versus 0.063 in the control group ( rate ratio 1.07 [ 95 % credible interval ( CrI ) : 0.57 to 1.89 ] ) and did not achieve the prespecified criteria noninferiority ( upper boundary of 95 % CrI 1.75 ) .


The rate for the second coprimary efficacy endpoint ( stroke or SE > 7 days ' postrandomization ) was 0.0253 versus 0.0200 ( risk difference 0.0053 [ 95 % CrI : -0.0190 to 0.0273 ] ) , achieving noninferiority .


Early safety events occurred in 2.2 % of the Watchman arm , significantly lower than in PROTECT AF , satisfying the pre-specified safety performance goal .


Using a broader , more inclusive definition of adverse effects , these still were lower in PREVAIL ( Watchman LAA Closure Device in Patients With Atrial Fibrillation Versus Long Term Warfarin Therapy ) trial than in PROTECT AF ( 4.2 % vs. 8.7 % ; p = 0.004 ) .


Pericardial effusions requiring surgical repair decreased from 1.6 % to 0.4 % ( p = 0.027 ) , and those requiring pericardiocentesis decreased from 2.9 % to 1.5 % ( p = 0.36 ) , although the number of events was small .


In this trial , LAA occlusion was noninferior to warfarin for ischemic stroke prevention or SE > 7 days ' post-procedure .


Although noninferiority was not achieved for overall efficacy , event rates were low and numerically comparable in both arms .


Procedural safety has significantly improved .


This trial provides additional data that LAA occlusion is a reasonable alternative to warfarin therapy for stroke prevention in patients with NVAF who do not have an absolute contraindication to short-term warfarin therapy .


To compare the clinical outcome and complications of high viscosity and low viscosity poly-methyl methacrylate bone cement PVP for severe OVCFs .


From December 2010 to December 2012 , 32 patients with severe OVCFs were randomly assigned to either group H using high viscosity cement ( n = 14 ) or group L using low viscosity cement ( n = 18 ) .


The clinical outcomes were assessed by the Visual Analog Scale ( VAS ) , Oswestry Disability Index ( ODI ) , Short Form-36 General Health Survey ( SF-36 ) , kyphosis Cobb 's angle , vertebral height , and complications .


Significant improvement in the VAS , ODI , SF-36 scores , kyphosis Cobb 's angle , and vertebral height were noted in both the groups , and there were no significant differences between the two groups .


Cement leakage was seen less in group H. Postoperative assessment using computed tomography identified cement leakage in 5 of 17 ( 29.4 % ) vertebrae in group H and in 15 of 22 ( 68.2 % ) vertebrae in group L ( P = 0.025 ) .


The PVP using high viscosity bone cement can provide the same clinical outcome and fewer complications compared with PVP using low viscosity bone cement .


Therapeutic vaccination is a promising novel approach to treat HIV-1 infected people by boosting or redirecting immune system to neutralize critical HIV-1 antigens whose biological effects are relevant in the context of viral pathogenesis .


With the aim to induce neutralizing antibodies to the matrix protein p17 we have developed a peptide-based immunogen ( AT20-KLH ) and evaluated its safety and immunogenicity .


Twenty four asymptomatic HAART-treated HIV-1 + patients were enrolled in a phase I clinical study and were randomized to three groups : 2 groups were treated with five IM injection ( Arm A : 25g/inoculation ; Arm B : 100g/inoculation ) at day ( D ) D0 , D28 , D56 , D84 and D112 ; the control group ( Arm C ) were not injected .


Safety was assessed by monitoring local and systemic adverse events ( AEs ) , recorded till D168 .


Evaluation of immunogenicity was by titering antibodies at D0 , D35 , D56 , D63 , D84 , D91 , D112 , D140 and D168 using ELISA .


In all , 105 local and systemic AEs were reported across the three groups .


Most were mild and resolved without sequelae .


Also the few unsolicited events , deemed unrelated to the study vaccines , caused no problems .


No significant changes in the routine laboratory parameters , CD4 T-cell count or HIV-1 viremia were found .


At the time of enrollment 23 out of 24 patients had no anti-AT20 antibodies , whereas 11 exhibited anti-p17 antibodies .


Irrespective of the presence of preimmunization antibodies , all subjects developed high titers of anti-AT20 antibodies ( GM 9775 ) in response to both AT20-KLH doses .


These antibodies were also capable of recognizing AT20 within the p17 framework .


The AT20 peptide-based approach has allowed to redirect HAART-treated patients ' humoral responses toward a previously untargeted hotspot of functional activity .


Overall , the tested AT20-KLH doses were safe and well tolerated , supporting further exploration of AT20-KLH as an HIV-1 therapeutic vaccine candidate .


Hypertensive patients with electrocardiographic left ventricular hypertrophy are at increased risk of all-cause and cardiovascular death .


Lowering blood pressure ( BP ) after stroke reduces the risk of recurrent stroke , but recent data suggest that lower systolic BP ( SBP ) measured 5 years after stroke is associated with increased mortality .


Whether lower SBP is associated with increased short-term mortality after stroke in hypertensive patients is unclear .


All-cause and cardiovascular mortality were examined in relation to average on-treatment SBP after stroke in 541 hypertensive patients with electrocardiographic left ventricular hypertrophy randomly assigned to losartan - or atenolol-based treatment who had new strokes during follow-up .


Patients with on-treatment SBP < 144 mm Hg ( lowest tertile ) and SBP > 157 ( highest tertile ) were compared with patients with average SBP between 144 and 157 .


During 2.021.65 years mean follow-up after incident stroke , 170 patients ( 31.4 % ) died , 135 ( 25.0 % ) from cardiovascular causes .


In multivariate Cox analyses , adjusting for significant univariate predictors of mortality , compared with average SBP between 144 and 157 , an average SBP < 144 was a significant predictor of all-cause ( hazard ratio , 1.81 ; 95 % confidence interval , 1.20-2 .73 ) and cardiovascular mortality ( hazard ratio , 1.60 ; 95 % confidence interval , 1.02-2 .54 ) , whereas patients who had an average SBP > 157 had no significant increased risk of death .


Lower achieved SBP ( < 144 mm Hg ) is associated with a significantly increased risk of cardiovascular and all-cause mortality after initial stroke in hypertensive patients during short-term follow-up .


Further study is required to determine ideal SBP goals after stroke .


URL : http://clinicaltrials.gov/ .


Unique identifier : NCT00338260 .


LifeWave Energy Enhancer ( LEE ) patches ( LifeWave Corp , San Diego , CA , USA ) on skin produce some changes that are consistent with increased energy production , but little is known about their effects on cortisol concentrations or the peripheral circulation .


The study intended to assess the effects of LEE patches on salivary cortisol , peripheral circulation , and psychological measures on healthy adults .


A double-blind , placebo-controlled , randomized pilot study was performed .


Measurements were made in the laboratory at Mind-Body-Science ( Tucson , AZ , USA ) .


Participants collected some of the saliva samples at work or home .


To obtain pilot data , 20 healthy individuals with no chronic conditions were recruited-5 males and 15 females-aged 30-69 y.


Participants completed baseline psychological questionnaires and provided saliva samples for hormonal analysis .


The next day , fingertip microvascular perfusion was measured , LEE or placebo patches were applied to participants ' wrists , and perfusion scans were repeated , first immediately after and then 10 min after application of the patch .


Saliva samples were collected , and questionnaires were completed .


Participants returned at noon and 4:00 PM for further scans , and at the end of that time , the patches were removed .


The protocol was repeated the following day using new patches .


The research team analyzed the saliva samples for levels of cortisol and measured the percentage changes in cutaneous microvascular perfusion .


The participants completed the energy visual analog scales ( eVASs ) and the Marlowe-Crowne Social Desirability survey .


After the first patch application , the active group showed significantly higher cortisol concentrations than the placebo group , both at noon-2 .39 0.17 ng/mL vs 2.15 0.27 ( P = .0360 ) , respectively-and at 4:00 PM - 2.02 0.24 vs 1.67 0.31 ( P = .0155 ) , respectively .


No consistent changes occurred in perfusion .


The eVAS score decreased significantly compared with baseline in the placebo group but not in the active group .


Cortisol concentrations and eVAS scores showed significant differences between groups , which is consistent with the patches increasing energy production , warranting further testing .


Due to the availability of new devices , the use of ventricular assist devices ( VADs ) in children has been increasing ; however , patient selection and optimal timing of device implantation in this population remains uncertain .


A retrospective review of the United Network for Organ Sharing dataset identified 5,200 listings without mechanical circulatory support ( MCS ) for isolated pediatric heart transplant , 1995 to 2012 .


Patients were randomly divided into a derivation and validation cohort .


A multivariable logistic regression model predicting the likelihood of death or need for MCS within 60 days was built using the derivation cohort and tested in the validation cohort .


A simplified score ( PedsMCS score ) was developed and evaluated for accuracy .


The predictive model consisted of variables present at listing ( age , albumin level , creatinine clearance , serum bilirubin , mechanical ventilation , and inotropic support ) .


It had good predictive ability ( C statistic 0.7304 ) within the validation cohort .


The simplified PedsMCS score was also predictive ( C statistic 0.7217 ) and there was a strong correlation between predicted and expected outcomes ( r = 0.91 , p < 0.0001 ) .


Patients with PedsMCS score 16 or greater had a significantly higher risk of death or MCS within 2 months ( 36.6 % ) than those with low scores ( < 6 ) ( 1.5 % , p < 0.0001 ) .


A single point increase in PedsMCS score was associated with a 16.7 % increase in the risk of death or MCS with 2 months ( p < 0.0001 ) .


We have developed and validated a simplified score to predict the need for MCS based on risk factors present at listing .


This will provide more accurate prognostication in children awaiting heart transplant , and may improve patient selection .


Not all hypertensive patients respond well to ACE inhibition .


Here we determined whether renin-angiotensin system ( RAS ) phenotyping , i.e. , the measurement of renin or ACE , can predict the individual response to RAS blockade , either chronically ( enalapril vs. enalapril + candesartan ) or acutely ( enalaprilhydrochlorothiazide , HCT ) .


Chronic enalapril + candesartan induced larger renin rises , but did not lower blood pressure ( BP ) more than enalapril .


Similar observations were made for enalapril + HCT vs. enalapril when given acutely .


Baseline renin predicted the peak changes in BP chronically , but not acutely .


Baseline ACE levels had no predictive value .


Yet , after acute drug intake , the degree of ACE inhibition , like renin , did correlate with BP .


Only the relationship with renin remained significant after chronic RAS blockade .


Thus , a high degree of ACE inhibition and a steep renin rise associate with larger acute responses to enalapril .


However , variation was large , ranging > 50mm Hg for a given degree of ACE inhibition or renin .


The same was true for the relationships between renin and BP , and between baseline renin and the maximum reduction in BP in the chronic study .


Our data do not support that RAS phenotyping will help to predict the individual BP response to RAS blockade .


Notably , these conclusions were reached in a carefully characterized , homogenous population , and when taking into account the known fluctuations in renin that relate to gender , age , ethnicity , salt intake and diuretic treatment , it seems unlikely that a cut-off renin level can be defined that has predictive value .


The main challenge in CT screening for lung cancer is the high prevalence of pulmonary nodules and the relatively low incidence of lung cancer .


Management protocols use thresholds for nodule size and growth rate to determine which nodules require additional diagnostic procedures , but these should be based on individuals ' probabilities of developing lung cancer .


In this prespecified analysis , using data from the NELSON CT screening trial , we aimed to quantify how nodule diameter , volume , and volume doubling time affect the probability of developing lung cancer within 2 years of a CT scan , and to propose and evaluate thresholds for management protocols .


Eligible participants in the NELSON trial were those aged 50-75 years , who have smoked 15 cigarettes or more per day for more than 25 years , or ten cigarettes or more for more than 30 years and were still smoking , or had stopped smoking less than 10 years ago .


Participants were randomly assigned to low-dose CT screening at increasing intervals , or no screening .


We included all participants assigned to the screening group who had attended at least one round of screening , and whose results were available from the national cancer registry database .


We calculated lung cancer probabilities , stratified by nodule diameter , volume , and volume doubling time and did logistic regression analysis using diameter , volume , volume doubling time , and multinodularity as potential predictor variables .


We assessed management strategies based on nodule threshold characteristics for specificity and sensitivity , and compared them to the American College of Chest Physicians ( ACCP ) guidelines .


The NELSON trial is registered at www.trialregister.nl , number ISRCTN63545820 .


Volume , volume doubling time , and volumetry-based diameter of 9681 non-calcified nodules detected by CT screening in 7155 participants in the screening group of NELSON were used to quantify lung cancer probability .


Lung cancer probability was low in participants with a nodule volume of 100 mm ( 3 ) or smaller ( 06 % [ 95 % CI 04-08 ] ) or maximum transverse diameter smaller than 5 mm ( 04 % [ 02-07 ] ) , and not significantly different from participants without nodules ( 04 % [ 03-06 ] , p = 017 and p = 100 , respectively ) .


Lung cancer probability was intermediate ( requiring follow-up CT ) if nodules had a volume of 100-300 mm ( 3 ) ( 24 % [ 95 % CI 17-35 ] ) or a diameter 5-10 mm ( 13 % [ 10-18 ] ) .


Volume doubling time further stratified the probabilities : 08 % ( 95 % CI 04-17 ) for volume doubling times 600 days or more , 40 % ( 18-83 ) for volume doubling times 400-600 days , and 99 % ( 69-141 ) for volume doubling times of 400 days or fewer .


Lung cancer probability was high for participants with nodule volumes 300 mm ( 3 ) or bigger ( 169 % [ 95 % CI 141-200 ] ) or diameters 10 mm or bigger ( 152 % [ 127-181 ] ) .


The simulated ACCP management protocol yielded a sensitivity and specificity of 909 % ( 95 % CI 812-961 ) , and 872 % ( 864-879 ) , respectively .


A diameter-based protocol with volumetry-based nodule diameter yielded a higher sensitivity ( 924 % [ 95 % CI 831-971 ] ) , and a higher specificity ( 900 % [ 893-907 ) .


A volume-based protocol ( with thresholds based on lung cancer probability ) yielded the same sensitivity as the ACCP protocol ( 909 % [ 95 % CI 812-961 ] ) , and a higher specificity ( 949 % [ 944-954 ] ) .


Small nodules ( those with a volume < 100 mm ( 3 ) or diameter < 5 mm ) are not predictive for lung cancer .


Immediate diagnostic evaluation is necessary for large nodules ( 300 mm ( 3 ) or 10 mm ) .


Volume doubling time assessment is advocated only for intermediate-sized nodules ( with a volume ranging between 100-300 mm ( 3 ) or diameter of 5-10 mm ) .


Nodule management protocols based on these thresholds performed better than the simulated ACCP nodule protocol .


Zorgonderzoek Nederland Medische Wetenschappen and Koningin Wilhelmina Fonds .


The aim of this research was to compare the pharmacodynamics of the combination of mitiglinide and sitagliptin to that of each agent alone in Korean patients with type 2 diabetes mellitus ( T2DM ) .


Patients with T2DM received mitiglinide alone , sitagliptin alone , or both drugs together in randomized sequence .


A meal tolerance test ( MTT ) was conducted for each group , and plasma concentrations of glucose , insulin , C-peptide , glucagon , and intact glucagon-like peptide-1 , and dipeptidyl peptidase-4 activity were measured from 2 h before breakfast through 4 h after breakfast on day 0 ( pretreatment ) and day 1 ( posttreatment ) of each treatment period .


Integrated values of these pharmacodynamic variables were analyzed for changes from pretreatment to posttreatment and for differences between the three treatment groups .


Twenty-six patients with glycated hemoglobin A1c level of 7.4 % 0.6 % , fasting plasma glucose concentration of 141 22 mg/dL , postprandial plasma glucose ( PPG ) concentration of 264 48 mg/dL 1 h after the MTT , and diabetes duration of 3.0 3.1 years ( mean SD ) were included in the study .


Compared with mitiglinide or sitagliptin alone , the combination treatment lowered PPG additively ( P < 0.001 vs. mitiglinide or sitagliptin alone ) and the insulin secretory response ( P = 0.03 vs. mitiglinide or sitagliptin alone ) .


The integrated insulin concentrations changed significantly from before to after treatment ( P < 0.01 ) , but the change did not differ between the combination and mitiglinide groups .


The insulinogenic index increased significantly after the combination treatment ( P < 0.001 vs. mitiglinide or sitagliptin alone ) .


The combination of mitiglinide and sitagliptin was generally well tolerated , with no hypoglycemic events .


The combination of mitiglinide and sitagliptin did not trigger hypoglycemia and controlled postprandial glucose excursion more effectively compared with either drug alone .


Alterations of the parameters of heart rate variability , phenomenon associated with autonomic nervous system balance , have been shown as a possibly very important factor for monitoring of cardiocirculatory system in the perioperative period .


Periinduction period of general anaesthesia is very important with significant changes of haemodynamics what could be reflected in the changes of the parameter of heart rate variability .


A hundred patients of ASA I and ASA II status who were scheduled for elective abdominal surgical procedures of moderate stress response , were randomly assigned to group I and group II , who were administered propofol or thiopentone as induction anaesthetic , respectively .


Monitoring during periinduction period included of monitoring of mean blood pressure ( noninvasively ) , heart rate , pulseoxymetry and recording of electrocardiogram by holter ECG recorder for further analysis of heart rate variability , in four time segments in periinduction period : Tp , T1 , T2 , T3 .


Data were presented as mean values of absolute values of the power of the total spectrum of heart rate variability , mean values of the spectrum of low frequency band ( LF ) , mean values of the high frequency range , and the ratio LF/HF .


Analysis of the values of hemodynamic parameters has shown decrease of mean arterial blood pressure after induction of anaesthesia with intravenous anesthetics thiopental or propofol , with simultaneous changes of heart rate in the four time segments in periinduction period , without statistically significant changes between the groups .


Analysis of the values of parameters of heart rate variability measured in the frequency domain has shown changes of mean values of the absolute values of total power spectrum , mean values of the power of low frequency spectrum and mean values of the power of high power spectrum with reduction of the values of total power spectrum , the power of low frequency spectrum and the power of high frequency spectrum , most pronounced just after induction of anaesthesia with slight increase of the values of total power spectrum and individual components of the spectrum of heart rate variability in the later postinduction period , without statistically significant differences between the groups .


The results have shown that in the groups of patients who underwent induction of general anaesthesia with propofol or thiopentone , there have been reductions of the total spectral power and the power of the spectrum of low frequency components and high frequency components with variations in the relationship between the components in the different periods of periinduction time .


In a task-environment where visibility has deteriorated , individuals rely heavily on tactile performance ( perception and manipulation ) to complete complex tasks .


When this happens under hyperbaric conditions , factors like nitrogen narcosis could influence a person 's ability to successfully complete such tasks .


To examine the effect of nitrogen narcosis on a complex neuropsychological task measuring tactile performance at a pressure of 608 kPa ( 6 atm abs ) , in the absence of visual access to the task .


In a prospective cross-over study , 139 commercial divers were tested in a dry chamber at 101.3 kPa and 608 kPa .


They completed the Tupperware Neuropsychological Task ( TNT ) of tactile performance without visual access to the task , and completed questionnaires to provide psychological and biographical data , which included trait anxiety and transient mood states , as well as formal qualifications and technical proficiency .


A significant decrement ( 9.5 % , P < 0.001 ) in performance on the TNT at depth was found , irrespective of the sequence of testing .


Generally , neither the psychological nor biographical variables showed any significant effect on tactile performance .


Tactile performance on the surface was a good indicator of performance at depth .


These findings have practical implications for professional diving where conditions of low visibility during deeper diving occur .


Recommendations are made towards managing potential impairments in tactile performance , such as pre-dive practical learning ( ` rehearsal ' ) as an aid to successful completion of tasks .


To compare the results for treatment of basal thumb osteoarthritis with and without the use of a bone tunnel at the base of the first metacarpal .


Women aged 40 years or older with stage IV osteoarthritis were randomized to 1 of 2 treatments .


Patients were evaluated preoperatively and postoperatively at 3 and 12 months by assessing pain , outcome function measures , range of motion , strength , time to return to work or activities , satisfaction with the results , and complication rate .


A total of 79 patients were enrolled in this study .


Three months after surgery , Patient-Rated Wrist and Hand Evaluation pain and total scores were significantly improved in the bone tunnel group compared with the tunnel-free group .


At 12 months , however , we found no significant differences for all outcome scores between groups .


In addition , we observed no significant differences between groups in strength , duration to return to work or activities , patient satisfaction , and complication rates .


After the bone tunnel technique , patients have better function and less pain 3 months after surgery than do those in the non-bone tunnel group , which indicates faster recovery .


However , 12 months after surgery , the functional outcome was similar .


Because of faster recovery , we prefer the bone tunnel technique in the treatment of stage IV osteoarthritis .


Therapeutic I.


Within the field of oncology , increasing access to high quality care has been identified as a priority to reduce cancer disparities .


Previous research reveals that the facilities where patients receive their cancer care have implications for cancer outcomes .


However , there is little understanding of how patients decide where to seek cancer care .


This study examined the factors that shape patients ' pathways to seek their cancer care at a National Cancer Institute-designated comprehensive cancer center ( NCI-CCC ) , and differences in these factors by race , income and education .


In-depth interviews and survey questionnaires were administered to a random sample of 124 patients at one NCI-CCC in the Northeast US .


In-depth interview data was first analyzed qualitatively to identify themes and patterns in patients ' pathways to receive their cancer care at an NCI-CCC .


Logistic Regression was used to examine if these pathways varied by patient race , income , and education .


Two themes emerged : following the recommendation of a physician and following advice from social network members .


Quantitative data analysis shows that patient pathways to care at an NCI-CCC varied by education and income .


Patients with lower income and education most commonly sought their cancer care at an NCI-CCC due to the recommendation of a physician .


Patients with higher income and education most commonly cited referral by a specialist physician or the advice of a social network member .


There were no statistically significant differences in pathways to care by race .


Our findings show that most patients relied on physician recommendations or advice from a social network member in deciding to seek their cancer care at an NCI-CCC .


Due to the role of physicians in shaping patients ' pathways to the NCI-CCC , initiatives that strengthen partnerships between NCI-CCCs and community physicians who serve underserved communities may improve access to NCI-CCCs .


The aim of the present study is to determine the possible effect of Bifidobacterium bifidum DN-173 010 on dental plaque of children .


52 children ( 25 F and 27 M ) , between the ages of 8-10 , participated in the present study .


The study had a double blind , randomized crossover design and the experimental period consisted of four consecutive time periods .


During periods 2 and 4 ( 2 weeks each ) , children consumed 110 g probiotic fruit yogurt ( Bifidobacterium DN-173 010 ( 1 x 10 ( 10 ) cfu/g ) ) , or a placebo fruit yogurt per day .


Available supragingival plaque ( 24 h later ) was collected from teeth 16 , 11 , 36 and 31 at baseline and at the end of periods 2 and 4 .


The counts of dental plaque mutans streptococci ( MS ) were evaluated using Dentocult SM ( Strep Mutans ) .


Changes of pre - and post-treatment levels of dental plaque MS were recorded for four consecutive sampling sites .


There were no statistically differences between transition scores of test and placebo groups regarding different dental plaque sampling sites ( p > 0.05 ) ( unpaired t-test ) .


Within the limitations of the present study , Bifidobacterium bifidum DN-173 010 has no effect on dental plaque MS levels in children .


Accumulating evidence indicates that plastic changes can be maladaptive in nature , resulting in movement and neurological disorders .


The aim of this study was to further the understanding of these neurophysiological changes in sensorimotor integration ( SMI ) using somatosensory evoked potentials ( SEPs ) and concurrent performance changes following a repetitive typing task .


SEPs were recorded following median nerve stimulation at the wrist and performed pre and post intervention .


24 participants were randomly assigned to either an intervention group which performed a 20min repetitive typing task or a control group which participated in a 20min period of mental recitation .


The P22-N24 amplitude increased by 59.6 % , compared to only 0.96 % increase following the control .


The P22-N30 SEP peak amplitude increased on average 13.4 % following the motor training , compared to only 0.92 % following the control .


Significant improvement in reaction time when comparing performance of the motor task for the intervention group was observed .


The N24 increase supports the involvement of cerebellar connections and the N30 increase provides further support for changes in SMI following motor learning .


Combining motor training tasks with electrophysiological techniques gives insight into the mechanisms of disordered SMI and whether the changes are adaptive or maladaptive .


Electrocardiographic ( ECG ) identification of prior myocardial infarction ( MI ) during right ventricular ( RV ) pacing is of clinical importance .


Proposed ECG criteria have been evaluated only during apical pacing .


We evaluated the effect of pacing site on the predictive performance of ECG signs of prior MI .


The present study is a secondary analysis of a prospective , multicenter study which randomized recipients of an implantable cardioverter defibrillator to an apical versus septal RV lead positioning .


ECGs of patients with or without prior MI were analyzed for the presence of the following criteria : Cabrera sign , Chapman sign , QR pattern in leads I , aVL , V5 or V6 , QR in inferior leads and notching in the descending slope of the QRS complex in inferior leads .


The MI group included 89 patients ( 55.1 % apically paced ) , while 99 patients had no prior MI ( 50.5 % apically paced ) .


In the total population , the Cabrera sign presented the highest specificity ( 97 % ) and diagnostic accuracy ( 62.2 % ) , with a sensitivity of 23.6 % .


The Cabrera sign was the only significant predictor of a prior MI [ OR = 9.9 , ( 95 % CI :2.8 -34.5 ) , p < 0.001 ] , among all ECG markers .


Pacing site did not significantly influence the sensitivity and specificity of the Cabrera sign for detection of prior MI .


In our study , the Cabrera sign was the only ECG marker that predicted the presence of prior MI during ventricular paced rhythm .


Septal RV lead positioning did not affect the predictive performance of the Cabrera sign .


To observe the protective effect of transcutaneous electrical acupoint stimulation ( TEAS ) on cerebral tissue in elderly hip replacement operation patients during general anesthesia under controlled hypotension .


Forty hip replacement operation patients were randomly divided into general anesthesia ( GA ) control group and TEAS + GA group ( n = 20 in each group ) .


Patients of the two groups during operation were treated with controlled hypotension for reducing blood loss .


TEAS ( 2 Hz/100 Hz , 8-12 mA ) was applied to bilateral Yuyao ( EX-HN 4 ) and Fengchi ( GB 20 ) and began 30 min before GA. .


General anesthesia was performed by intravenous injection of Midazolam , Diprivan , Fentanyl and Cis-atracurium , sevoflurane-inhaling , Remifentanil , etc. , and the patient 's mean arterial pressure was maintained to be about 70 % of the normal level ( controlled hypotension ) by using venous administration of Remifentanil about 10 min after the operation .


GEM Premier 3000 blood gas analyzer was used to analyze levels of the arterial oxygen ( CaO2 ) , internal jugular venous oxygen ( CjvO2 ) , arterio-venous oxygen content difference ( Da-jvO2 ) and cerebral oxygen ( CERO2 ) uptake rates of blood samples before controlled hypotension ( T0 ) , 20 min after controlled hypotension ( T ) .


40 min after controlled hypotension ( T2 ) and 20 min after the end of controlled hypotension ( T3 ) .


Self-comparison of each group showed that in comparison with pre-controlled hypotension , CjvO2 levels at the time-points of T , T2 and T3 were significantly increased in both GA control and TEAS+GA groups ( P < 0.05 ) , while Da-jvO2 and CERO2 uptake rate levels at the time-points of T , .


T2 and T3 in these two groups were significantly decreased ( P < 0.05 ) .


Comparison between two groups showed that CivO2 levels at the time-points of T2 and T3 were significantly higher in the TEAS + GA group than in the GA control group ( P < 0.05 ) .


while Da-jvO2 and CERO2 uptake rate levels at the time-point of T2 were obviously lower in the TEAS + GA group than in the GA control group ( P < 0.05 ) , suggesting a reduction of cerebral oxygen consumption after TEAS .


No significant differences were found between these two groups in blood CjvO2 , Da-jvO2 and CERO2 uptake rate levels at the time-points of T0 and T1 ( P > 0.05 ) .


TEAS can reduce cerebral oxygen uptake rate in elderly patients undergoing hip replacement during controlled hypotension , suggesting a protective effect of TEAS on patient 's cerebral tissue .


Home mechanical ventilation ( HMV ) in the Netherlands is normally initiated in hospital , but this is expensive and often a burden for the patient .


In this randomised controlled study we investigated whether initiation of HMV at home in patients with chronic respiratory failure is non-inferior to an in hospital based setting .


Seventy-seven patients were included , of which 38 patients started HMV at home .


All patients were diagnosed with chronic respiratory failure due to a neuromuscular or thoracic cage disease .


Primary outcome was the arterial carbon dioxide ( PaCO2 ) while quality of life and costs were secondary outcomes .


Telemonitoring was used in the home group to provide therapeutic information , for example ; transcutaneous carbon dioxide , oxygen saturation and ventilator information , to the caregivers .


Follow-up was six months .


PaCO2 , improved by 0.72 ( SE0 .16 ) kPa in the hospital group and by 0.91 ( 0.20 ) in the home group , both improvements being significant and the latter clearly not inferior .


There were also significant improvements in quality of life in both groups , again not being inferior with home treatment .


This study is the first to show that initiation of HMV at home in a selective group of patients with chronic respiratory failure is as effective for gas exchange and quality of life as hospital initiation .


In addition we found that it is safe , technically feasible and that more than 3000 per patient can be saved compared to our standard care .


To compare the three non-steroidal anti-inflammatory agents ( NSAIDs ) Diclofenac potassium , Etodolac and Naproxen sodium in relation to pain , swelling and trismus following impacted third molar surgery .


The study was a randomized and a double-blinded study which included 42 healthy young individuals with impacted third molars and bone retention .


Patients were randomly assigned to 3 groups ( n : 14 ) to which Diclofenac potassium , Naproxen sodium and Etodolac were administered orally an hour before the operation .


Impacted third molars were surgically extracted with local anaesthesia .


Visual analog scales ( VAS ) were used to assess the pain in the 6th , 12th hours and on the 1st , 2nd , 3rd , 5th , and 7th days postoperatively .


Swelling was evaluated using ultrasound ( US ) and mouth opening ( trismus ) was measured with a composing stick pre and post operatively on the 2nd and 7th days respectively .


Regarding pain alleviation , Diclofenac potassium was better than Naproxen sodium and Naproxen sodium was better than Etodolac but these differences were not statistically significant .


US measurements showed that the swelling on postoperative 2nd day was significantly lowest with Diclofenac potassium as compared to others ( p = 0.027 ) while Naproxen sodium and Etodolac acted similarly ( p = 0.747 ) .


No difference was noted regarding trismus in any of the groups .


NSAIDs ( Diclofenac , Naproxen and Etodolac ) are somehow similarly effective for controlling pain and trismus following extraction of mandibular third molars but Diclofenac potassium surpasses others in reduction of swelling .


To observe the efficacy of the combination of Qilin Pills and levofloxacin in the treatment of asthenospermia accompanied with accessory sex gland infection .


We randomly assigned 80 asthenospermia patients with accessory sex gland infection to groups 1 and 2 of equal number , the former treated with Qilin Pills + levofloxacin , and the latter with levofloxacin only .


Qilin Pills were administered at the dose of 6 g tid for 30 days , and levofloxacin at the dose of 0.5 g qd for 20 days .


We obtained semen parameters , including the percentage of progressively motile sperm and peroxidase-positive white blood cell ( WBC ) count , before and after medication , and compared the clinical effects between the two groups .


All the patients accomplished the clinical trial .


The therapeutic effectiveness rates in improving progressive sperm motility were 60 % in group 1 and 17.5 % in group 2 , with statistically significant differences between the two groups ( P < 0.05 ) .


As for the peroxidase-positive WBC count in semen , the effectiveness rates were 87.5 % and 82.5 % , respectively , with no significant differences between the two groups ( P > 0.05 ) .


For the treatment of asthenospermia accompanied with accessory sex gland infection , Qilin Pills combined with levofloxacin is evidently better than levofloxacin alone in improving sperm motility , and it has no obvious adverse effects .


To investigate the association between feeding patterns and HIV-free survival in children born to HIV-infected mothers and to clarify whether antiretroviral ( ARV ) prophylaxis modifies the association .


From June 2005 to August 2008 , HIV-infected pregnant women were counseled regarding infant feeding options , and randomly assigned to triple-ARV prophylaxis ( triple ARV ) until breastfeeding cessation ( BFC ) before age 6 months or antenatal zidovudine with single-dose nevirapine ( short-course ARV ) .


Eighteen-month HIV-free survival of infants HIV-negative at 2 weeks of age was assessed by feeding patterns ( replacement feeding from birth , BFC < 3 months , BFC 3 months ) .


Of the 753 infants alive and HIV-negative at 2 weeks , 28 acquired infection and 47 died by 18 months .


Overall HIV-free survival at 18 months was 0.91 [ 95 % confidence interval ( CI ) : 0.88-0 .93 ] .


In the short-course ARV arm , HIV-free survival ( 0.88 ; CI : 0.84-0 .91 ) did not differ by feeding patterns .


In the triple ARV arm , overall HIV-free survival was 0.93 ( CI : 0.90-0 .95 ) and BFC < 3 months was associated with lower HIV-free survival than BFC 3 months ( adjusted hazard ratio : 0.36 ; CI : 0.15-0 .83 ) and replacement feeding ( adjusted hazard ratio : 0.20 ; CI : 0.04-0 .94 ) .


In the triple ARV arm , 4 of 9 transmissions occurred after reported BFC ( and 5 of 19 in the short-course arm ) , indicating that some women continued breastfeeding after interruption of ARV prophylaxis .


In resource-constrained settings , early weaning has previously been associated with higher infant mortality .


We show that , even with maternal triple-ARV prophylaxis during breastfeeding , early weaning remains associated with lower HIV-free survival , driven in particular by increased mortality .


Fluticasone furoate ( FF ) is a novel , once-daily inhaled corticosteroid ( ICS ) that has been shown to improve lung function vs. placebo in asthma patients .


This study evaluated the efficacy and safety of FF 50 mcg compared with placebo in asthma patients uncontrolled by non-ICS therapy .


This 12-week , multicentre , randomized , double-blind , placebo-controlled , parallel-group , phase III study randomized 248 patients ( aged 12 years ) to once-daily FF 50 mcg administered via the ELLIPTAa dry powder inhaler or placebo .


The primary endpoint was change from baseline in pre-dose evening trough forced expiratory volume in one second ( FEV1 ) .


Secondary endpoints were change from baseline in percentage of rescue-free 24-h periods ( powered ) , evening and morning peak expiratory flow , symptom-free 24-h periods and withdrawals due to lack of efficacy .


Other endpoints included Asthma Control Test , Asthma Quality of Life Questionnaire and ELLIPTA ease of use questions .


Safety was assessed throughout the study .


There was a significant difference in evening trough FEV1 between FF 50 mcg and placebo ( treatment difference : 120 mL ; p = 0.012 ) .


There was also a significant difference in rescue-free 24-h periods ( 11.6 % ; p = 0.004 ) vs. placebo .


There were numerically greater improvements with FF vs. placebo for all remaining secondary endpoints .


The incidence of adverse events was lower with FF ( 31 % ) than with placebo ( 38 % ) ; few were treatment-related ( FF 50 mcg : n = 1 , < 1 % ; placebo : n = 4 , 3 % ) .


FF 50 mcg once daily significantly improved FEV1 and percentage of rescue-free 24-h periods experienced over 12 weeks vs. placebo , and was well tolerated .


www.clinicaltrials.gov , registration number : NCT01436071 .


The aim of this study was to compare the effects of plyometric training versus basketball technique training on improving neuro-muscular performance .


Thirty-six ( age 14.90.9 years , body height 164.07.6 cm , body weight 54.08.7 kg , BMI 20.12.4 kgm-2 ) basketball players girls were randomly allocated to 2 groups : Basketball Plyometric Training ( BPT , N. = 18 ) and Basketball Technique Training ( BTT , N. = 18 ) .


The players were tested by two specific tests : counter movement jump ( CMJ ) and squat jump ( SJ ) before and after 6 training weeks .