Knee anterior cruciate ligament reconstruction ( ACLR ) may be painful in the postoperative period .


The primary objective of this study was to evaluate whether the use of femoral nerve block ( FNB ) associated with spinal anesthesia would improve the postoperative pain treatment in ACLR and the secondary objectives were to evaluate tramadol request and adverse events .


53 patients were randomly divided into two groups : GA ( n = 26 ) received spinal anesthesia and GB ( n = 27 ) received spinal anesthesia and FNB .


All patients received multimodal analgesia and rescue analgesics could be requested anytime .


Assessments were performed at 6 , 12 and 24 hours .


There was no difference between both groups regarding demographic and clinical - surgical variables .


There was no difference between groups regarding pain intensity .


Mean pain scores were higher at 12 hours in GA and there was no change in GB ; 55.6 % of patients reported moderate pain in GA and 53.8 % mild pain in GB .


There was no difference regarding tramadol request .


There were no serious adverse events : 80.8 % of patients in GB had motor block of the thigh and two fell .


Analgesia was more effective with the combination of spinal and FNB , which allowed better control of postoperative pain , assessed 12 hours after anesthesia .


There was no difference in tramadol request .


Patients in this study had no serious adverse events ; however , one must be attentive to motor paralysis and the possibility of falling when FNB is performed .


We compared biweekly irinotecan plus cisplatin ( BIRIP ) with irinotecan alone as the second-line chemotherapy ( SLC ) for advanced gastric cancer ( AGC ) .


Patients with metastatic or recurrent gastric cancer refractory to S-1-based first-line chemotherapy were randomly assigned to receive BIRIP ( irinotecan 60mg/m ( 2 ) plus cisplatin 30mg/m ( 2 ) , every 2weeks ) or irinotecan alone ( irinotecan 150mg/m ( 2 ) , every 2weeks ) .


The primary end-point was to show the superiority of BIRIP to irinotecan in terms of progression free survival ( PFS ) .


130 patients were enrolled .


PFS was significantly longer in the BIRIP group ( 3.8 months [ 95 % confidence interval ( CI ) 3.0-4 .7 ] ) than in the irinotecan group ( 2.8 months [ 2.1-3 .3 ] ; hazard ratio 0.68 , 95 % CI 0.47-0 .98 ; P = 0.0398 ) .


Median overall survival was 10.7 months in the BIRIP group and 10.1 months in the irinotecan group ( HR 1.00 , 95 % CI 0.69-1 .44 , P = 0.9823 ) .


The objective response rate was 22 % in the BIRIP group and 16 % in the irinotecan group ( P = 0.4975 ) .


However , the disease control rate was significantly better in the BIRIP group ( 75 % ) than in the irinotecan group ( 54 % , P = 0.0162 ) .


The incidences of grade 3 or worse adverse events did not differ between the two groups .


Any grade elevation of serum creatinine was more common in the BIRIP group ( 25 % versus 8 % , P = 0.009 ) , but any grade diarrhoea ( 17 % versus 42 % , P = 0.002 ) was more common in the irinotecan group .


BIRIP significantly prolonged PFS as compared with irinotecan alone and was tolerated as SLC , but did not demonstrate the survival benefit in this trial .


Hypertension is the leading global risk factor for mortality .


Hypertension treatment and control rates are low worldwide , and delays in seeking care are associated with increased mortality .


Thus , a critical component of hypertension management is to optimize linkage and retention to care .


This study investigates whether community health workers , equipped with a tailored behavioral communication strategy and smartphone technology , can increase linkage and retention of hypertensive individuals to a hypertension care program and significantly reduce blood pressure among them .


The study will be conducted in the Kosirai and Turbo Divisions of western Kenya .


An initial phase of qualitative inquiry will assess facilitators and barriers of linkage and retention to care using a modified Health Belief Model as a conceptual framework .


Subsequently , we will conduct a cluster randomized controlled trial with three arms : 1 ) usual care ( community health workers with the standard level of hypertension care training ) ; 2 ) community health workers with an additional tailored behavioral communication strategy ; and 3 ) community health workers with a tailored behavioral communication strategy who are also equipped with smartphone technology .


The co-primary outcome measures are : 1 ) linkage to hypertension care , and 2 ) one-year change in systolic blood pressure among hypertensive individuals .


Cost-effectiveness analysis will be conducted in terms of costs per unit decrease in blood pressure and costs per disability-adjusted life year gained .


This study will provide evidence regarding the effectiveness and cost-effectiveness of strategies to optimize linkage and retention to hypertension care that can be applicable to non-communicable disease management in low - and middle-income countries .


This trial is registered with ( NCT01844596 ) on 30 April 2013 .


Inotropes are widely used in hospitalized systolic heart failure ( HF ) patients , especially those with low systolic blood pressure ( SBP ) or cardiac index .


In addition , inotropes are considered to be harmful in nonischemic HF .


We examined the association of in-hospital inotrope use with ( 1 ) major events ( death , ventricular assist device , or heart transplant ) and ( 2 ) study days alive and out of hospital during the first 6 months in the Evaluation Study of Congestive Heart Failure and Pulmonary Artery Catheterization Effectiveness , which excluded patients with immediate need for inotropic therapy .


Predefined subgroups of interest were baseline SBP < 100 versus 100 mm Hg , cardiac index < 1.8 vs 1.8 L min ( -1 ) m ( -2 ) , and ischemic versus nonischemic HF etiology .


Inotropes were frequently used in both the < 100 mm Hg ( 88/165 [ 53.3 % ] ) and the 100 mm Hg ( 106/262 [ 40.5 % ] ) SBP subgroups and were associated with higher risk for major events in both subgroups ( adjusted hazard ratio [ HR ] 2.85 , 95 % confidence interval [ CI ] 1.59-5 .12 [ P < .001 ] ; and HR 1.86 , 95 % CI 1.02-3 .37 [ P = .042 ] ; respectively ) .


Risk with inotropes was more pronounced among those with cardiac index 1.8 L min ( -1 ) m ( -2 ) ( n = 114 ; HR 4.65 , 95 % CI 1.98-10 .9 ; P < .001 ) vs < 1.8 L min ( -1 ) m ( -2 ) ( n = 82 ; HR 1.48 , 95 % CI 0.61-3 .58 ; P = .39 ) .


Event rates were higher with inotropes in both ischemic ( n = 215 ; HR 2.64 , 95 % CI 1.49-4 .68 ; P = .001 ) and nonischemic ( n = 216 ; HR 2.19 , 95 % CI 1.18-4 .07 ; P = .012 ) patients .


Across all subgroups , patients who received inotropes spent fewer study days alive and out of hospital .


In the absence of cardiogenic shock or end-organ hypoperfusion , inotrope use during hospitalization for HF was associated with unfavorable 6-month outcomes , regardless of admission SBP , cardiac index , or HF etiology .


Home mechanical ventilation is usually initiated in hospital .


However , cost-effectiveness of inpatient set up has never been compared to outpatient adaptation in a randomized design .


A Prospective , multicenter , non-inferiority trial was conducted comparing the effectiveness of adaptation to noninvasive mechanical ventilation ( NIMV ) performed in the ambulatory or hospital setting in patients with chronic respiratory failure secondary to restrictive thoracic disease , obesity-hypoventilation syndrome or neuromuscular disease .


The study included 53 candidates for NIMV , randomized to ambulatory adaptation ( AA ) ( n = 27 ) or hospital adaptation ( HA ) ( n = 26 ) .


The patients ' characteristics were recorded before establishing ventilation and at 1 and 6 months after .


The main outcome variable was PaCO2 decrease at 6 months following initiation of NIMV .


The direct costs of the two interventions were compared .


Before starting NIMV , PaCO2 was 50.46.8 mmHg in the AA group and 50.35.7 mmHg in the HA group .


At 6 months of NIMV use , a significant improvement in PaCO2 relative to baseline was found in both groups : mean ( 95 % CI ) PaCO2 decrease was 4.9 ( 2.3 ; 7.4 ) mmHg in AA and 3.3 ( 1.4 ; 5.1 ) mmHg in HA .


The direct calculated cost was 1500 euros per patient in AA and 2692 euros per patient in HA .


Adaptation to NIMV in the ambulatory setting is not inferior to hospital adaptation in terms of therapeutic equivalence in stable patients with chronic respiratory failure secondary to restrictive thoracic disease , obesity-hypoventilation syndrome or neuromuscular disease .


Outpatient adaptation may represent a cost saving for the healthcare system .


Identifier number NCT00698958 at www.clinicaltrials.gov .


Emergency medical research performed under federal regulation 21 CFR 50.24 provides a means to protect human subjects and investigate novel time-sensitive treatments .


Although prospective individual consent is not required for studies conducted under this regulation , consent from a legally authorized representative ( LAR ) or the patient at the earliest feasible opportunity is required to obtain short - and long-term outcome data .


The objective of this study was to determine which demographic , cardiac arrest , and patient outcome characteristics predicted the likelihood of obtaining informed consent following enrollment under exception from informed consent in a multicenter cardiac arrest study .


This investigation was an analysis of data collected during a multisite , randomized , controlled , out-of-hospital cardiac arrest clinical trial performed under 21 CFR 50.24 .


Research personnel attempted to obtain informed consent from LARs and subjects for medical records review of primary outcome data , as well as consent for neurologic outcome assessments up to 1 year post-cardiac arrest .


Hospital discharge and neurologic status were obtained from public records and/or medical records up until the time consent was formally denied , in accordance with federal regulations and guidance .


Local institutional review boards also allowed medical records review for cases where consent was neither obtained nor declined despite multiple consent attempts .


Patient demographic , cardiac arrest , and clinical outcome characteristics were analyzed in univariate multinomial regression models , with consent status ( obtained , denied , neither obtained nor denied ) as the dependent variable .


A multivariate multinomial logistic regression was then performed .


An exploratory secondary analysis following the same process was performed after assigning patients who neither consented nor declined to the declined consent group .


Among a total study population of 1,655 cardiac arrest subjects , 457 were transported and had consent attempted ( 27.6 % ) .


The survival status and neurologic function at the time of hospital discharge were known in 440 of 457 ( 96 % ) subjects .


In the multivariate analysis , initial rhythm of ventricular fibrillation/ventricular tachycardia ( VF/VT ) and survival with good neurologic outcome were strong predictors of obtaining consent ( odds ratio [ OR ] = 3.15 , 95 % confidence interval [ CI ] = 1.73 to 5.75 ; OR = 7.64 , 95 % CI = 2.28 to 25.63 , respectively ) .


The exploratory secondary analysis also showed initial rhythm of VF/VT and survival with good neurologic outcome as strong predictors of obtaining consent ( OR = 1.86 , 95 % CI = 1.17 to 2.95 ; OR = 4.52 , 95 % CI = 2.21 to 9.26 , respectively ) .


Initial arrest rhythm and survival with good neurologic outcome were highly predictive of obtaining consent in this cardiac arrest trial .


This phenomenon could result in underrepresentation of outcome data in the study arm with the worse outcome and represents a significant potential confounder in studies performed under 21 CFR 50.24 .


Future revisions to the exception from informed consent regulations should allow access to critical survival data recorded as part of standard documentation , regardless of patient consent status .


Cancer and other chronic diseases reduce quality and length of life and productivity , and represent a significant financial burden to society .


Evidence-based public health approaches to prevent cancer and other chronic diseases have been identified in recent decades and have the potential for high impact .


Yet , barriers to implement prevention approaches persist as a result of multiple factors including lack of organizational support , limited resources , competing emerging priorities and crises , and limited skill among the public health workforce .


The purpose of this study is to learn how best to promote the adoption of evidence based public health practice related to chronic disease prevention .


This paper describes the methods for a multi-phase dissemination study with a cluster randomized trial component that will evaluate the dissemination of public health knowledge about evidence-based prevention of cancer and other chronic diseases .


Phase one involves development of measures of practitioner views on and organizational supports for evidence-based public health and data collection using a national online survey involving state health department chronic disease practitioners .


In phase two , a cluster randomized trial design will be conducted to test receptivity and usefulness of dissemination strategies directed toward state health department chronic disease practitioners to enhance capacity and organizational support for evidence-based chronic disease prevention .


Twelve state health department chronic disease units will be randomly selected and assigned to intervention or control .


State health department staff and the university-based study team will jointly identify , refine , and select dissemination strategies within intervention units .


Intervention ( dissemination ) strategies may include multi-day in-person training workshops , electronic information exchange modalities , and remote technical assistance .


Evaluation methods include pre-post surveys , structured qualitative phone interviews , and abstraction of state-level chronic disease prevention program plans and progress reports .


clinicaltrials.gov : NCT01978054 .


To prospectively evaluate the survival benefit of dissection of the nerve plexus and lymphadenectomy in patients with pancreatic head cancer .


Despite randomized controlled trials on the extent of surgery in pancreatic cancer , attempts have been made to perform more extended resections .


A total of 244 patients were enrolled ; of these , 200 were randomized to undergo standard resection or extended resection , with the latter including the dissection of additional lymph nodes and the right half of the nerve plexus around the superior mesenteric artery and celiac axis .


We evaluated 167 patients from 7 centers who fulfilled all of the required criteria .


Operation time was longer and estimated blood loss was higher in the extended resection group than in the standard resection group , but the R0 resection rate was comparable .


The mean number of lymph nodes retrieved per patient was higher in the extended resection group than in the standard resection group ( 33.7 vs 17.3 ; P < 0.001 ) .


The morbidity rate was slightly higher in the extended resection group than in the standard resection group .


Two patients in the extended resection group died in hospital .


Median survival after R0 resection was similar in the extended resection and standard resection groups ( 18.0 vs 19.0 months ; P = 0.239 ) regardless of lymph node metastasis .


Adjuvant chemoradiation had a positive impact on overall survival .


This study suggests that extended lymphadenectomy with dissection of the nerve plexus does not provide a significant survival benefit compared with standard resection in pancreatic head cancer .


Standard resection can be performed safely and efficiently , without negatively affecting oncologic efficacy or long-term survival , when compared with extended pancreaticoduodenal resection .


( NCT00679913 ) ?


This proof-of-concept study investigated whether feedback-mediated exercise ( FME ) of the affected arm of hemiplegic patients increases patient motivation and promotes greater improvement of motor function , compared to no-feedback exercise ( NFE ) .


We developed a feedback-mediated treatment that uses gaming scenarios and allows online and offline monitoring of both temporal and spatial characteristics of planar movements .


Twenty poststroke hemiplegic inpatients , randomly assigned to the FME and NFE group , received therapy five days a week for three weeks .


The outcome measures were evaluated from the following : ( 1 ) the modified drawing test ( mDT ) , ( 2 ) received therapy time-RTT , and ( 3 ) intrinsic motivation inventory-IMI .


The FME group patients showed significantly higher improvement in the speed metric ( P < 0.01 ) , and smoothness metric ( P < 0.01 ) , as well as higher RTT ( P < 0.01 ) .


Significantly higher patient motivation is observed in the FME group ( interest/enjoyment subscale ( P < 0.01 ) and perceived competence subscale ( P < 0.01 ) ) .


Prolonged endurance in training and greater improvement in certain areas of motor function , as well as very high patient motivation and strong positive impressions about the treatment , suggest the positive effects of feedback-mediated treatment and its high level of acceptance by patients .


About one half of those who develop adult-onset moyamoya disease experience intracranial hemorrhage .


Despite the extremely high frequency of rebleeding attacks and poor prognosis , measures to prevent rebleeding have not been established .


The purpose of this study is to determine whether extracranial-intracranial bypass can reduce incidence of rebleeding and improve patient prognosis .


This study was a multicentered , prospective , randomized , controlled trial conducted by 22 institutes in Japan .


Adult patients with moyamoya disease who had experienced intracranial hemorrhage within the preceding year were given either conservative care or bilateral extracranial-intracranial direct bypass and were observed for 5 years .


Primary and secondary end points were defined as all adverse events and rebleeding attacks , respectively .


Eighty patients were enrolled ( surgical , 42 ; nonsurgical , 38 ) .


Adverse events causing significant morbidity were observed in 6 patients in the surgical group ( 14.3 % ) and 13 patients in the nonsurgical group ( 34.2 % ) .


Kaplan-Meier survival analysis revealed significant differences between the 2 groups ( 3.2 % / y versus 8.2 % / y ; P = 0.048 ) .


The hazard ratio of the surgical group calculated by Cox regression analysis was 0.391 ( 95 % confidence interval , 0.148-1 .029 ) .


Rebleeding attacks were observed in 5 patients in the surgical group ( 11.9 % ) and 12 in the nonsurgical group ( 31.6 % ) , significantly different in the Kaplan-Meier survival analysis ( 2.7 % / y versus 7.6 % / y ; P = 0.042 ) .


The hazard ratio of the surgical group was 0.355 ( 95 % confidence interval , 0.125-1 .009 ) .


Although statistically marginal , Kaplan-Meier analysis revealed the significant difference between surgical and nonsurgical group , suggesting the preventive effect of direct bypass against rebleeding .


http://www.umin.ac.jp/ctr/index.htm .


Unique identifier : C000000166 .


Previous studies demonstrated that vagus nerve stimulation ( VNS ) is an effective therapy for drug-resistant epilepsy .


Acupuncture is also used to treat epilepsy .


This study was designed to examine the safety and effectiveness of transcutaneous auricular vagus nerve stimulation ( ta-VNS ) for patients with drug-resistant epilepsy .


A total of 50 volunteer patients with drug-resistant epilepsy were selected for a random clinical trial to observe the therapeutic effect of ta-VNS .


The seizure frequency , quality of life , and severity were assessed in weeks 8 , 16 , and 24 of the treatment according to the percentage of seizure frequency reduction .


In the pilot study , 47 of the 50 epilepsy patients completed the 24-week treatment ; three dropped off .


After 8-week treatment , six of the 47 patients ( 12 % ) were seizure free and 12 ( 24 % ) had a reduction in seizure frequency .


In week 16 of the continuous treatment , six of the 47 patients ( 12 % ) were seizure free ; 17 ( 34 % ) had a reduction in seizure frequency .


After 24 weeks ' treatment , eight patients ( 16 % ) were seizure free ; 19 ( 38 % ) had reduced seizure frequency .


Similar to the therapeutic effect of VNS , ta-VNS can suppress epileptic seizures and is a safe , effective , economical , and widely applicable treatment option for drug-resistant epilepsy .


( ChiCTR-TRC-10001023 ) .


Prior investigations have suggested that physician-related factors may contribute to differential use of TKA among women and ethnic minorities .


We sought to evaluate the effect of surgeon bias on recommendations for TKA .


Using an experimental approach with standardized patient scenarios , we sought to evaluate surgeon recommendations regarding TKA , specifically to determine whether recommendations for TKA are influenced by ( 1 ) patient race , and ( 2 ) patient sex .


We developed four computerized scenarios for all combinations of race ( white or black ) and sex ( male or female ) for otherwise similar patients with end-stage knee osteoarthritis .


Patients gave an orthopaedic history of 2years worsening pain with decreased functional status and failure of oral antiinflammatory medications and corticosteroid intraarticular injections .


Orthopaedic surgeons attending the 2012 annual meetings of the New York State Society of Orthopaedic Surgeons and American Association of Hip and Knee Surgeons were recruited for the study .


Surgeons passing an open recruitment table at each meeting were asked to participate .


Of the 1111 surgeons in attendance at either meeting , 113 ( 10.2 % ) participated in the study .


All participants viewed the `` control '' patient 's story ( white male ) and were randomized to view one of the three `` experimental '' scenarios ( white female , black male , black female ) .


After viewing each scenario , the participants were anonymously asked whether they would recommend TKA .


An a priori power analysis showed that 112 participants were needed to detect a 15 % difference in the likelihood of recommending surgery for white versus nonwhite patients in the test scenarios evaluated with 90 % power at a level of significance of 0.05 .


Of the 39 surgeons who viewed the white male plus black female scenario , there were 33 ( 85 % ) concordant responses ( TKA offered to both patients ) and six discordant responses ( TKA offered to only one of the patients ) , with no effect of patient race and sex ( p = 0.99 ) .


Of the 37 surgeons who viewed the white male plus black male scenario , there were 33 ( 89 % ) concordant responses and four discordant responses , with no effect of patient race ( p = 0.32 ) .


Of the 37 surgeons who viewed the white male plus white female scenario , there were 30 ( 77 % ) concordant responses and seven discordant responses , with no effect of patient sex ( p = 0.71 ) .


After orthopaedic surgeons viewed video scenarios of patients with end-stage knee osteoarthritis , patient race and sex were not associated with a different likelihood of a surgical recommendation .


Our findings support the notion that patient race and sex may be less influential on decision making when there are strong clinical data to support a decision .


Physician bias may have a greater effect on decision making in situations where the indications for surgery are less clear .


Metformin may improve metabolic factors ( insulin , glucose , leptin , highly sensitive C-reactive protein [ hs-CRP ] ) associated with poor breast cancer outcomes .


The NCIC Clinical Trials Group ( NCIC CTG ) MA .32 investigates effects of metformin vs placebo on invasive disease-free survival and other outcomes in early breast cancer .


Maintaining blinding of investigators to outcomes , we conducted a planned , Data Safety Monitoring Committee-approved , analysis of the effect of metformin vs placebo on weight and metabolic factors at six months , including examination of interactions with baseline body mass index ( BMI ) and insulin , in the first 492 patients with paired blood samples .


Eligible nondiabetic subjects with T1-3 , N0-3 , M0 breast cancer who had completed surgery and ( neo ) adjuvant chemotherapy ( if given ) provided fasting plasma samples at random assignment and at six months .


Glucose was measured locally ; blood was aliquoted , frozen , and stored at -80 C. Paired plasma aliquots were analyzed for insulin , hs-CRP , and leptin .


Spearman correlation coefficients were calculated and comparisons analyzed using Wilcoxon signed rank test .


All statistical tests were two-sided .


Mean age was 52.19.5 years in the metformin group and 52.6 9.8 years in the placebo group .


Arms were balanced for estrogen/progesterone receptor , BMI , prior ( neo ) adjuvant chemotherapy , and stage .


At six months , decreases in weight and blood variables were statistically significantly greater in the metformin arm ( vs placebo ) in univariate analyses : weight -3.0 % , glucose -3.8 % , insulin -11.1 % , homeostasis model assessment -17.1 % , leptin -20.2 % , hs-CRP -6.7 % ; all P values were less than or equal to .03 .


There was no statistically significant interaction of change in these variables with baseline BMI or insulin .


Metformin statistically significantly improved weight , insulin , glucose , leptin , and CRP at six months .


Effects did not vary by baseline BMI or fasting insulin .


To observe the efficacy of acupuncture on pain after replantation of severed finger .


A total of 80 patients who underwent replantation of severed finger were randomly divided into an observation group and a control group , 40 cases in each one .


The patients in the control group were treated with postoperative routine care of hand surgery , while patients in the observation group , based on the regular treatment , were treated with acupuncture within first 72 h of surgery .


The health side of Yanglingquan ( GB 34 ) , Xuehai ( SP 10 ) , Hegu ( LI 4 ) , Houxi ( SI 3 ) were selected and the needles were retained for 30 min .


The acupuncture was given for 6 times .


The evaluation was performed by using visual analogue scale ( VAS ) 2 h , 4 h , 6 h , 12 h , 24 h , 48 h and 72 h after surgery .


The use of analgesics after surgery was recorded in the two groups , and the blood supply and survival rate of severed finger were evaluated .


Compared between the two groups , the VAS 4 h , 6 h , 12 h , 24 h and 48 h after surgery in the observation group was lower than that in the control group ( all P < 0.05 ) ; the use frequency of analgesics in the observation group was lower than that in the control group ( P < 0.05 ) ; the abnormality rate of blood supply in the observation group was lower than that in the control group ( P < 0.05 ) .


Acupuncture can significantly relieve postoperative pain of replantation of severed finger , and reduce the occurrence rate of abnormal blood supply , which is worthy of clinical promotion .


Back pain is a common and disabling condition for people in rural and remote areas .


In these areas , access to rehabilitation services is limited by service availability .


Telerehabilitation is suggested as a solution for providing physical therapy services ; however , the validity of clinical assessment is largely unproven .


The aim of this study was to establish the validity of clinically pragmatic remote assessment of spinal posture , active movements of the lumbar spine , and the passive straight leg raise ( SLR ) test .


Face-to-face physical therapist assessment was compared with telerehabilitation assessment of spinal posture , active movements of the lumbar spine , and the SLR test .


Twenty-six participants recruited from a rural population with current or recent low back pain ( LBP ) were assessed by a face-to-face physical therapist and a remote physical therapist .


Pain , disability , and clinical measurements were assessed .


Outcomes were compared to establish agreement .


High levels of agreement were found with detecting pain with specific lumbar movements , eliciting symptoms , and sensitizing the SLR test .


Moderate agreement occurred with identifying the worst lumbar spine movement direction , SLR range of motion , and active lumbar spine range of motion .


Poor agreement occurred with postural analysis and identifying reasons for limitations to lumbar movements .


Conducted in a rural clinical setting , this study validates elements of the physical assessment of the lumbar spine and identifies technical and clinical issues to be addressed by future research .


Important components of the standard musculoskeletal assessment of LBP are valid via telerehabilitation in a clinical setting .


To compare 2 lenticule insertion methods currently in use for Descemet stripping automated endothelial keratoplasty ( DSAEK ) .


Prospective randomized single-masked study .


Twenty patients with Fuchs endothelial dystrophy and pseudophakic bullous keratopathy undergoing DSAEK surgery were included and randomized to the use of either EndoGlide or EndoSerter as a delivery method for the donor lenticule .


Post surgery , patients were monitored for up to 1 year .


Evaluation included corrected distance visual acuity ( CDVA ) and refraction .


Specular microscopy images were obtained at the 6 - and 12-month visits .


Complications , including rebubbling rate , graft dislocation , and graft failure , were recorded .


Twenty eyes were randomized to receive the Tan EndoGlide or the EndoSerter injector for lenticule insertion .


Mean patient age was 65.98.4 years and 70.39.8 years in the Tan EndoGlide and EndoSerter groups , respectively ( P = .3 ) .


Two eyes in each group needed rebubbling .


The mean endothelial cell loss , including the rebubbled eyes , at the 12-month visit was 1093629 cells/mm2 ( range : 239-2109 cells/mm2 , mean percentage cell loss 41.2 % ) and 877566 cells/mm2 ( range : 116-1851 cells/mm2 , mean percentage cell loss 31.4 % ) in the Tan EndoGlide and EndoSerter groups , respectively ( P = .45 ) .


Mean CDVA did not show a statistically significant difference between the 2 groups at the 6 - or 12-month visit .


The EndoSerter shows comparable results to the Tan EndoGlide .


However , further investigation is warranted in order to validate these findings .


Even in stable asthma patients , acinar ventilation distribution can be abnormal , and we aimed to specifically maximize its reversibility by switching patients from a standard inhaled corticosteroid ( iCS ) to a fine particle iCS formulation .


For this prospective double-blind double-dummy randomized study , 66 stable asthma patients under maintenance iCS ( equivalent budesonide 800 g/day ) were screened for abnormal baseline acinar ventilation heterogeneity ( Sacin ) .


After a 3-week run-in period , 35 eligible patients were randomized to fine particle beclomethasone ( HFA-BDP ; Qvar Autohaler ) or to budesonide ( DPI-BUD ; Pulmicort Turbohaler ) .


Asthma Control Test ( ACT ) score and various lung function indices reflecting the small airways were obtained at baseline , after 6 and 12 weeks .


Thirty one patients [ age :52 17 ( SD ) years ; FEV1 :76 19 ( SD ) % pred ] completed the study ( DPI-BUD : n = 16 ; HFA-BDP : n = 15 ) .


After 6 and 12 weeks , there were no significant changes in acinar or conductive ventilation heterogeneity , nor in mid-expiratory flow , RV/TLC , closing capacity , impulse oscillometry indices ( resistance , reactance ) , bronchial NO production or alveolar NO , in either treatment arm .


Asthma control was maintained in both arms .


In stable asthma patients with small airways dysfunction under maintenance therapy , there is a residual functional abnormality in the lung periphery which is probably not eosinophilic in origin and can not be normalized with the iCS formulations under study .


ISRCTN17195095 .


Biomedical treatment options for autism spectrum disorder ( ASD ) are extremely limited .


Repetitive transcranial magnetic stimulation ( rTMS ) is a safe and efficacious technique when targeting specific areas of cortical dysfunction in major depressive disorder , and a similar approach could yield therapeutic benefits in ASD , if applied to relevant cortical regions .


The aim of this study was to examine whether deep rTMS to bilateral dorsomedial prefrontal cortex improves social relating in ASD .


28 adults diagnosed with either autistic disorder ( high-functioning ) or Asperger 's disorder completed a prospective , double-blind , randomized , placebo-controlled design with 2 weeks of daily weekday treatment .


This involved deep rTMS to bilateral dorsomedial prefrontal cortex ( 5 Hz , 10-s train duration , 20-s inter-train interval ) for 15 min ( 1500 pulses per session ) using a HAUT-Coil .


The sham rTMS coil was encased in the same helmet of the active deep rTMS coil , but no effective field was delivered into the brain .


Assessments were conducted before , after , and one month following treatment .


Participants in the active condition showed a near significant reduction in self-reported social relating symptoms from pre-treatment to one month follow-up , and a significant reduction in social relating symptoms ( relative to sham participants ) for both post-treatment assessments .


Those in the active condition also showed a reduction in self-oriented anxiety during difficult and emotional social situations from pre-treatment to one month follow-up .


There were no changes for those in the sham condition .


Deep rTMS to bilateral dorsomedial prefrontal cortex yielded a reduction in social relating impairment and socially-related anxiety .


Further research in this area should employ extended rTMS protocols that approximate those used in depression in an attempt to replicate and amplify the clinical response .


To elucidate the relationship between CYP2D6 genotype and risperidone pharmacokinetics and extrapyramidal symptoms we propose the APSEP pharmacogenetic clinical trial .


Twenty-five healthy subjects were included in this randomized , placebo-controlled , single dose ( risperidone 2.5 mg ) crossover and double-blind clinical trial .


Subjects were selected according to their CYP2D6 genotype and classified as : poor metabolizers ( n = 8 ) , extensive metabolizers ( n = 10 ) and ultrarapid metabolizers ( n = 7 ) .


Our study demonstrates that CYP2D6 predicted 65 % of the risperidone metabolism variability .


Moreover , its ability to predict actigraphy records is similar to the predictive power of pharmacokinetic parameters ( 24 % ) .


Our results also highlight the need for the development of pharmacogenetic predictors that take into account the complexity of pharmacokinetic and pharmacodynamic relationships .


Tedizolid phosphate is a novel antibacterial under investigation for the treatment of gram-positive infections .


This study was conducted to assess the pharmacokinetics , safety , and tolerability of intravenous tedizolid phosphate as well as the oral bioavailability of tedizolid phosphate .


Double-blind , single-ascending dose , multiple-dose pharmacokinetics study , as well as tolerability and open-label crossover studies .


Single center in the United States ( Covance Clinical Research Unit , Madison , WI ) between September 2009 and January 2010 .


Ninety healthy volunteers .


Single intravenous ( IV ) doses of tedizolid phosphate 50 mg ( lead-in ) and 100-400 mg .


Single oral and IV dose of tedizolid phosphate 200 mg in crossover fashion .


Multiple IV doses of tedizolid phosphate 200 and 300 mg for up to 7 days .


A dose-dependent increase was observed in the maximum plasma concentration ( 1.2-5 .1 g/ml ) and the area under the concentration-time curve ( 17.4-58 .7 g hr/ml ) of tedizolid ( the microbiologically active moiety of tedizolid phosphate ) after single IV doses of tedizolid phosphate 100-400 mg .


Administration of IV tedizolid phosphate 200 mg once/day for 7 days resulted in minimal ( 28 % ) tedizolid accumulation .


The absolute oral bioavailability of tedizolid after a single 200-mg dose of tedizolid phosphate was 91 % ; pharmacokinetic parameters of tedizolid were similar with oral and IV administration .


Treatment-related adverse events occurred in 41 % of subjects .


Most adverse events were related to infusion site and became more frequent with multiple dosing .


In an additional 3-day tolerability study , IV tedizolid phosphate 200 mg and placebo were similarly tolerated , based on visual infusion phlebitis scores .


These results from a population of healthy volunteers support once/day dosing of tedizolid phosphate 200 mg with both the oral and IV formulations , without the need for dose adjustment when switching administration routes .


The risk of stroke in patients with atrial fibrillation ( AF ) increases with age .


In the ARISTOTLE trial , apixaban when compared with warfarin reduced the rate of stroke , death , and bleeding .


We evaluated these outcomes in relation to patient age .


A total of 18 201 patients with AF and a raised risk of stroke were randomized to warfarin or apixaban 5 mg b.d. with dose reduction to 2.5 mg b.d. or placebo in 831 patients with 2 of the following criteria : age 80 years , body weight 60 kg , or creatinine 133 mol/L .


We used Cox models to compare outcomes in relation to patient age during 1.8 years median follow-up .


Of the trial population , 30 % were < 65 years , 39 % were 65 to < 75 , and 31 % were 75 years .


The rates of stroke , all-cause death , and major bleeding were higher in the older age groups ( P < 0.001 for all ) .


Apixaban was more effective than warfarin in preventing stroke and reducing mortality across all age groups , and associated with less major bleeding , less total bleeding , and less intracranial haemorrhage regardless of age ( P interaction > 0.11 for all ) .


Results were also consistent for the 13 % of patients 80 years .


No significant interaction with apixaban dose was found with respect to treatment effect on major outcomes .


The benefits of apixaban vs. warfarin were consistent in patients with AF regardless of age .


Owing to the higher risk at older age , the absolute benefits of apixaban were greater in the elderly .


The 5-year clinical outcomes and prognostic factors of nasopharyngeal carcinoma ( NPC ) patients treated with intensity modulated radiotherapy ( IMRT ) were evaluated .


Six hundred ninety five NPC patients primarily treated with IMRT in Sichuan Cancer Hospital from January , 2003 to December , 2006 were analyzed retrospectively , including 540 males and 155 females .


The prescription dose was delivered as follows : gross target volume ( GTVnx ) 67-76 Gy in 30-33 fractions , positive neck lymph nodes ( GTVln-R/L ) 60-70 Gy in 30-33 fractions , high-risk clinical target volume ( CTV1 ) 60-66 Gy , low-risk clinical target volume ( CTV2 ) 54-60 Gy , and clinical target volume of cervical lymph node regions ( CTVln ) 50-55 Gy .


The 5-year local control ( LC ) , regional control , distant metastasis-free survival ( DMFS ) , disease free survival , disease specific survival , and overall survival ( OS ) rates were 89.8 % , 95.2 % , 74.1 % , 69.6 % , 83.2 % , and 77.1 % .


The 5-year DMFS of IMRT and IMRT combined with chemotherapy was 62.1 % and 70.9 % , the OS of them was 72.9 % and 79.1 % .


The incidence of grade 3 acute and late toxicity was 38.3 % and 4.2 % , respectively .


The 5-year LC and OS rate of NPC treated with IMRT was 89.8 % and 77.1 % .


The clinical stage , N stage , volume of GTVnx , and chemotherapy were the main prognostic factor for the OS .


Distant metastasis was the main pattern of failure .


Measure the impact of facial defect reconstruction on observer-graded attractiveness and negative facial perception .


Prospective , randomized , controlled experiment .


One hundred twenty casual observers viewed images of faces with defects of varying sizes and locations before and after reconstruction as well as normal comparison faces .


Observers rated attractiveness , defect severity , and how disfiguring , bothersome , and important to repair they considered each face .


Facial defects decreased attractiveness -2.26 ( 95 % confidence interval [ CI ] : -2.45 , -2.08 ) on a 10-point scale .


Mixed effects linear regression showed this attractiveness penalty varied with defect size and location , with large and central defects generating the greatest penalty .


Reconstructive surgery increased attractiveness 1.33 ( 95 % CI : 1.18 , 1.47 ) , an improvement dependent upon size and location , restoring some defect categories to near normal ranges of attractiveness .


Iterated principal factor analysis indicated the disfiguring , important to repair , bothersome , and severity variables were highly correlated and measured a common domain ; thus , they were combined to create the disfigured , important to repair , bothersome , severity ( DIBS ) factor score , representing negative facial perception .


The DIBS regression showed defect faces have a 1.5 standard deviation increase in negative perception ( DIBS : 1.69 , 95 % CI : 1.61 , 1.77 ) compared to normal faces , which decreased by a similar magnitude after surgery ( DIBS : -1.44 , 95 % CI : -1.49 , -1.38 ) .


These findings varied with defect size and location .


Surgical reconstruction of facial defects increased attractiveness and decreased negative social facial perception , an impact that varied with defect size and location .


These new social perception data add to the evidence base demonstrating the value of high-quality reconstructive surgery .


NA .


The aim of the present study was to evaluate the effect of adjunctive chlorhexidine ( CHX ) mouthrinse on gingival crevicular fluid ( GCF ) MMP-8 and TIMP-1 levels in plaque-associated gingivitis .


A total of 50 gingivitis patients were included in the present study .


In addition to daily plaque control , CHX group rinsed with CHX , while placebo group rinsed with placebo mouthrinse for 4 weeks .


GCF samples were collected , and clinical parameters including plaque index , papillary bleeding index , calculus index and pocket depth were recorded at baseline and 4 weeks .


GCF MMP-8 and TIMP-1 levels were determined by immunofluorometric assay ( IFMA ) and enzyme-linked immunosorbent assay ( ELISA ) , respectively .


In both groups , GCF MMP-8 levels of anterior and posterior sites at four weeks were not different from baseline ( p > 0.05 ) .


There were no significant differences in GCF MMP-8 levels between the study groups at four weeks ( p > 0.05 ) .


GCF TIMP-1 levels of anterior and posterior sites at four weeks were higher compared to baseline in both groups ( p < 0.05 ) .


There was no significant difference in GCF TIMP level between the study groups at four weeks ( p > 0.05 ) .


CHX usage had no significant effects on the GCF MMP-8 and TIMP-1 levels in plaque-associate gingivitis .


However , daily plaque control resulted in the increase of GCF TIMP-1 levels regardless of CHX usage .


Attentional resources appear to be involved in the occurrence of FoG .


The Parkgait study recently reported that methylphenidate reduces gait hypokinesia and freezing of gait ( FoG ) in advanced PD patients receiving STN-DBS in the off-dopaminergic drug condition .


Methylphenidate is considered to improve attention .


The primary objective of the present ancillary study was to determine whether methylphenidate reduced the interference between a cognitive task and gait in patients with FoG .


The study 's secondary objective was to compare attentional performance in methylphenidate-treated and placebo-treated patients .


A total of 24 patients ( from two centers ) were included in the study .


Patients were randomly assigned 1:1 to a three-month course of methylphenidate ( 1mg/kg/day ) or placebo .


Patients were assessed after an acute L-dopa challenge .


The primary outcome criterion was the stride length ratio ( ( dual-task stride length minus free gait stride length ) / free gait stride length ) .


Trials with FoG episodes were excluded from the analysis .


Secondary outcomes included changes in reaction times for computerized attention tasks and FoG severity .


When comparing patients receiving methylphenidate with those receiving placebo , we did not observe any significant differences in the interaction between the dual task and gait or in attentional performance .


As in the main Parkgait study , methylphenidate did not reduce gait hypokinesia in patients receiving dopaminergic treatment .


Our present results suggest that the reduction in the number of FoG episodes previously observed in patients on methylphenidate was neither due to interaction between a dual-task and gait nor an increase in attentional performance .


Complementary and alternative medicine ( CAM ) use has been increasing and these unconventional therapies do have important adverse effects .


We evaluated predictors of CAM use among U.S. adults .


We analyzed the 2007 Health Information National Trends Survey ( n = 7503 ) and used logistic regression models to evaluate the association of demographic , lifestyle characteristics and healthcare perceptions of respondents who used CAM within the previous 12 months ( n = 1980 ) versus those who did not ( n = 5523 ) .


We used survey weights in all analyses and performed variance estimations using Taylor series linearization to account for the complex survey design .


Females ( odds ratio [ OR ] = 1.46 ; 95 % confidence interval [ CI ] : 1.15-1 .86 ) , college graduates ( OR = 1.61 ; 95 % CI : 1.24-2 .08 ) and those who considered the quality of their healthcare to be poor ( OR = 2.16 ; 95 % CI : 1.28-3 .65 ) were more likely to use CAM , whereas blacks ( OR = 0.58 ; 95 % CI : 0.39-0 .85 ) were less likely to use CAM .


Among CAM users , 47.6 % did not inform their doctors .


However , no factor predicted those who did not inform their doctors of their CAM use .


Many adults in the United States use CAM without informing their doctors .


Care providers should inquire about CAM usage from their patients , document them and counsel their patients regarding their use of these less regulated therapies .


Soy has been associated with lower risk of cardiovascular disease in Asian countries which consume daily soy .


Our study examined whether production of equol , an estrogen metabolite , affected the ability of soy nuts to improve cardiovascular risk factors .


Sixty postmenopausal women participated in a randomized , controlled , crossover trial of a Therapeutic Lifestyle Changes ( TLC ) diet alone and a TLC diet in which 0.5 cup of soy nuts ( 25 g of soy protein and 101 mg of aglycone isoflavones ) replaced 25 g of nonsoy protein daily .


Each diet was followed for 8 weeks at the end of which blood pressure ( BP ) , lipid levels , adhesion molecules and inflammatory markers were measured .


Women with MetS had significantly higher baseline body mass index ( BMI ) , BP , triglycerides ( TG ) , and soluble intercellular adhesion molecule ( sICAM ) than women without MetS .


In women with MetS on the soy diet , significant reductions in diastolic BP ( 7.7 % ; P = 0.02 ) , TG ( 22.9 % ; P = 0.02 ) , C-reactive protein ( CRP ) ( 21.4 % ; P = 0.01 ) and sICAM ( 7.3 % ; P = 0.03 ) were noted among equol producers compared to levels on the TLC diet .


No significant changes were noted in equol nonproducers .


Similarly , in women without MetS , only equol producers had significant reductions in diastolic BP ( 3.3 % , P = 0.02 ) and CRP ( 30 % , P = 0.04 ) .


In contrast to women with MetS , TG and sICAM levels were not affected in women without MetS , a finding possibly related to lower baseline levels .


Cardiovascular risk reduction with soy nuts is not uniform and may be greater among producers of equol .


The goal of the study was to assess semantic priming to emotion and nonemotion cue words using a novel measure of associational breadth for participants who either took rapid eye movement ( REM ) or nonrapid eye movement ( NREM ) naps or who remained awake ; assess relation of priming to REM sleep consolidation and REM sleep inertia effects .


The associational breadth task was applied in both a priming condition , where cue-words were signaled to be memorized prior to sleep ( primed ) , and a nonpriming condition , where cue words were not memorized ( nonprimed ) .


Cue words were either emotional ( positive , negative ) or nonemotional .


Participants were randomly assigned to either an awake ( WAKE ) or a sleep condition , which was subsequently split into NREM or REM groups depending on stage at awakening .


Hospital-based sleep laboratory .


Fifty-eight healthy participants ( 22 male ) ages 18 to 35 y ( Mage = 23.3 4.08 y ) .


The REM group scored higher than the NREM or WAKE groups on primed , but not nonprimed emotional cue words ; the effect was stronger for positive than for negative cue words .


However , REM time and percent correlated negatively with degree of emotional priming .


Priming occurred for REM awakenings but not for NREM awakenings , even when the latter sleep episodes contained some REM sleep .


Associational breadth may be selectively consolidated during REM sleep for stimuli that have been tagged as important for future memory retrieval .


That priming decreased with REM time and was higher only for REM sleep awakenings is consistent with two explanatory REM sleep processes : REM sleep consolidation serving emotional downregulation and REM sleep inertia .


There are several reports regarding the role of therapeutic diets for patients with non-alcoholic fatty liver disease ( NAFLD ) .


Therefore , the aim of this study was to determine the effects of a low-calorie , low-carbohydrate soy-containing diet on lipid profiles , liver enzymes , and coagulating factors in patients with NAFLD .


This was a randomized parallel clinical trial involving 45 patients with NAFLD .


The participants consumed three kinds of diets for 8 wk .


Patients were randomly assigned to consume a low-calorie diet ; a low-calorie , low-carbohydrate diet ; or a low-calorie , low-carbohydrate soy-containing diet .


Measurements were done according to the standard method .


Changes in weight were not significantly different in the three groups .


The low-calorie , low-carbohydrate soy-containing diet could reduce alanine aminotransferase ( -15.2 12.1 versus -6.8 4.6 in the low-calorie , low-carbohydrate diet , and -6.4 4.4 IU/L in the low-calorie diet ; P = 0.02 ) and serum fibrinogen levels ( -49.1 60.1 versus -12.9 8.1 and -17.4 8.4 g/L , respectively ; P = 0.01 ) .


Reductions in aspartate aminotransferase were significantly higher in the low-calorie , low-carbohydrate soy-containing group .


Changes in lipid profiles did not differ significantly between the groups .


The soy-containing diet did reduce malondialdehyde more than the other diets ( P = 0.01 ) .


A low-calorie , low-carbohydrate soy-containing diet could have beneficial effects on liver enzymes , malondialdehyde , and serum fibrinogen levels in patients with NAFLD .


Hyperkalemia ( serum potassium level , > 5.0 mmol per liter ) is associated with increased mortality among patients with heart failure , chronic kidney disease , or diabetes .


We investigated whether sodium zirconium cyclosilicate ( ZS-9 ) , a novel selective cation exchanger , could lower serum potassium levels in patients with hyperkalemia .


In this multicenter , two-stage , double-blind , phase 3 trial , we randomly assigned 753 patients with hyperkalemia to receive either ZS-9 ( at a dose of 1.25 g , 2.5 g , 5 g , or 10 g ) or placebo three times daily for 48 hours .


Patients with normokalemia ( serum potassium level , 3.5 to 4.9 mmol per liter ) at 48 hours were randomly assigned to receive either ZS-9 or placebo once daily on days 3 to 14 ( maintenance phase ) .


The primary end point was the exponential rate of change in the mean serum potassium level at 48 hours .


At 48 hours , the mean serum potassium level had decreased from 5.3 mmol per liter at baseline to 4.9 mmol per liter in the group of patients who received 2.5 g of ZS-9 , 4.8 mmol per liter in the 5-g group , and 4.6 mmol per liter in the 10-g group , for mean reductions of 0.5 , 0.5 , and 0.7 mmol per liter , respectively ( P < 0.001 for all comparisons ) and to 5.1 mmol per liter in the 1.25-g group and the placebo group ( mean reduction , 0.3 mmol per liter ) .


In patients who received 5 g of ZS-9 and those who received 10 g of ZS-9 , serum potassium levels were maintained at 4.7 mmol per liter and 4.5 mmol per liter , respectively , during the maintenance phase , as compared with a level of more than 5.0 mmol per liter in the placebo group ( P < 0.01 for all comparisons ) .


Rates of adverse events were similar in the ZS-9 group and the placebo group ( 12.9 % and 10.8 % , respectively , in the initial phase ; 25.1 % and 24.5 % , respectively , in the maintenance phase ) .


Diarrhea was the most common complication in the two study groups .


Patients with hyperkalemia who received ZS-9 , as compared with those who received placebo , had a significant reduction in potassium levels at 48 hours , with normokalemia maintained during 12 days of maintenance therapy .


( Funded by ZS Pharma ; ClinicalTrials.gov number , NCT01737697 . )


To compare the difference in the clinical efficacy on benign prostatic hyperplasia ( BPH ) between the acupuncture-moxibustion therapy and the medication of Qianliekang tablets .


One hundred and twenty-eight patients were randomized into an acupuncture-moxibustion group and a Qianliekang group , 64 cases in each one .


In the acupuncture-moxibustion group , acupuncture was applied to Shenshu ( BL 23 ) , Pangguangshu ( BL 28 ) , Zhongji ( CV 3 ) , Guanyuan ( CV 4 ) and Shuidao ( ST 28 ) , and the warm moxibustion therapy with moxa stick was used at Shenshu ( BL 23 ) , Guanyuan ( CV 4 ) and Shenque ( CV 8 ) , once every day .


In the Qianliekang group , Qianliekang tablets were prescribed for oral administration , 4 tablets each time , three times a day , for 3 months .


The International Prostate Symptom Score ( I-PSS ) and the changes in residual urine ( Ru ) and maximal urine flow rate ( Qmax ) determined with the ultrasonic B test were compared before and after treatment in the two groups .


The results of I-PSS , Qmax and Ru were improved obviously after treatment as compared with those before treatment in the two groups ( all P < 0.05 ) .


The improvements in the acupuncture-moxibustion group were much more obvious than those in the Qianliekang group [ 8.62 + / - 2.18 vs 15.26 + / - 2.81 , ( 16.04 + / - 4.33 ) mL/s vs ( 12.47 + / - 2.13 ) mL/s , ( 10.43 + / - 2.14 ) mL vs ( 32.13 + / - 3.24 ) mL , all P < 0.01 ] .


The total effective rate was 89.1 % ( 57/64 ) in the acupuncture-moxibustion group , which was better than 68.7 % ( 44/64 ) in the Qianliekang group .


Acupuncture-moxibustion therapy achieves the significant efficacy on BPH , which is better than the oral administration of Qianliekang tablets .


CALGB 40302 sought to determine whether lapatinib would improve progression-free survival ( PFS ) among women with hormone receptor-positive metastatic breast cancer treated with fulvestrant .


Eligible women had estrogen receptor-positive and/or progesterone receptor-positive tumors , regardless of human epidermal growth factor receptor 2 ( HER2 ) status , and prior aromatase inhibitor treatment .


Patients received fulvestrant 500 mg intramuscularly on day 1 , followed by 250 mg on days 15 and 28 and every 4 weeks thereafter , and either lapatinib 1,500 mg or placebo daily .


The study planned to accrue 324 patients and was powered for a 50 % improvement in PFS with lapatinib from 5 to 7.5 months .


At the third planned interim analysis , the futility boundary was crossed , and the data and safety monitoring board recommend study closure , having accrued 295 patients .


At the final analysis , there was no difference in PFS ( hazard ratio [ HR ] of placebo to lapatinib , 1.04 ; 95 % CI , 0.82 to 1.33 ; P = .37 ) ; median PFS was 4.7 months for fulvestrant plus lapatinib versus 3.8 months for fulvestrant plus placebo .


There was no difference in overall survival ( OS ) ( HR , 0.91 ; 95 % CI , 0.68 to 1.21 ; P = .25 ) .


For HER2-normal tumors , median PFS did not differ by treatment arm ( 4.1 v 3.8 months ) .


For HER2-positive tumors , lapatinib was associated with longer median PFS ( 5.9 v 3.3 months ) , but the differential treatment effect by HER2 status was not significant ( P = .53 ) .


The most frequent toxicities were diarrhea , fatigue , and rash associated with lapatinib .


Adding lapatinib to fulvestrant does not improve PFS or OS in advanced ER-positive breast cancer and is more toxic .


This study aimed to assess the impact of 3 heights of simulated altitude exposure on repeat-sprint performance in team-sport athletes .


Ten trained male team-sport athletes completed 3 sets of repeated sprints ( 9 4 s ) on a nonmotorized treadmill at sea level and at simulated altitudes of 2000 , 3000 , and 4000 m. Participants completed 4 trials in a random order over 4 wk , with mean power output ( MPO ) , peak power output ( PPO ) , blood lactate concentration ( Bla ) , and oxygen saturation ( SaO2 ) recorded after each set .


Each increase in simulated altitude corresponded with a significant decrease in SaO2 .


Total work across all sets was highest at sea level and correspondingly lower at each successive altitude ( P < .05 ; sea level < 2000 m < 3000 m < 4000 m ) .


In the first set , MPO was reduced only at 4000 m , but for subsequent sets , decreases in MPO were observed at all altitudes ( P < .05 ; 2000 m < 3000 m < 4000 m ) .


PPO was maintained in all sets except for set 3 at 4000 m ( P < .05 ; vs sea level and 2000 m ) .


BLa levels were highest at 4000 m and significantly greater ( P < .05 ) than at sea level after all sets .


These results suggest that `` higher may not be better , '' as a simulated altitude of 4000 m may potentially blunt absolute training quality .


Therefore , it is recommended that a moderate simulated altitude ( 2000-3000 m ) be employed when implementing intermittent hypoxic repeat-sprint training for team-sport athletes .


This study evaluates whether video-based coaching can enhance laparoscopic surgical skills performance .


Many professions utilize coaching to improve performance .


The sports industry employs video analysis to maximize improvement from every performance .


Laparoscopic novices were baseline tested and then trained on a validated virtual reality ( VR ) laparoscopic cholecystectomy ( LC ) curriculum .


After competence , subjects were randomized on a 1:1 ratio and each performed 5 VRLCs .


After each LC , intervention group subjects received video-based coaching by a surgeon , utilizing an adaptation of the GROW ( Goals , Reality , Options , Wrap-up ) coaching model .


Control subjects viewed online surgical lectures .


All subjects then performed 2 porcine LCs .


Performance was assessed by blinded video review using validated global rating scales .


Twenty subjects were recruited .


No significant differences were observed between groups in baseline performance and in VRLC1 .


For each subsequent repetition , intervention subjects significantly outperformed controls on all global rating scales .


Interventions outperformed controls in porcine LC1 [ Global Operative Assessment of Laparoscopic Skills : ( 20.5 vs 15.5 ; P = 0.011 ) , Objective Structured Assessment of Technical Skills : ( 21.5 vs 14.5 ; P = 0.001 ) , and Operative Performance Rating System : ( 26 vs 19.5 ; P = 0.001 ) ] and porcine LC2 [ Global Operative Assessment of Laparoscopic Skills : ( 28 vs 17.5 ; P = 0.005 ) , Objective Structured Assessment of Technical Skills : ( 30 vs 16.5 ; P < 0.001 ) , and Operative Performance Rating System : ( 36 vs 21 ; P = 0.004 ) ] .


Intervention subjects took significantly longer than controls in porcine LC1 ( 2920 vs 2004 seconds ; P = 0.009 ) and LC2 ( 2297 vs 1683 ; P = 0.003 ) .


Despite equivalent exposure to practical laparoscopic skills training , video-based coaching enhanced the quality of laparoscopic surgical performance on both VR and porcine LCs , although at the expense of increased time .


Video-based coaching is a feasible method of maximizing performance enhancement from every clinical exposure .


Metacognitive therapy ( MCT ) is one of the newer developments within cognitive therapy .


This randomized controlled pilot study compared independently applied MCT with cognitive behavioural therapy ( CBT ) in outpatients with depression to explore the relative speed and efficacy of MCT , ahead of a planned randomized controlled trial .


A total of 48 participants referred for outpatient therapy were randomized to up to 12 weeks of MCT or CBT .


Key outcomes were reduction in depressive symptoms at week 4 and week 12 , measured using the independent-clinician-rated Quick Inventory of Depressive Symptomatology16 .


Intention-to-treat and completer analyses as well as additional methods of reporting outcome of depression are presented .


Both therapies were effective in producing clinically significant change in depressive symptoms , with moderate-to-large effect sizes obtained .


No differences were detected between therapies in overall outcome or early change on clinician-rated or self-reported measures .


Post-hoc analyses suggest that MCT may have been adversely affected by greater comorbidity .


In this large pilot study conducted independently of MCT 's developers , MCT was an effective treatment for outpatients with depression , with similar results overall to CBT .


Insufficient power and imbalanced comorbidity limit conclusions regarding comparative efficacy so further studies of MCT and CBT are required .


The drug 3,4-methylenedioxymethamphetamine ( MDMA , `` ecstasy , '' `` molly '' ) is thought to produce prosocial effects and enhance social interaction .


However , in most laboratory studies to date , the participants have been tested under nonsocial conditions , which may not simulate the effects the drug produces in more naturalistic social settings .


Healthy experienced MDMA users participated in three laboratory sessions in which they received MDMA ( 0.5 or 1.0 mg/kg or placebo , double blind ) .


They were randomly assigned to one of three social conditions , in which they were tested alone ( solitary ( SOL ) ; N = 10 ) , in the presence of a research assistant ( research assistant present ( RAP ) ; N = 11 ) or in the presence of another participant who also received the drug ( other participant present ( OPP ) ; N = 11 ) .


As expected , MDMA increased heart rate and blood pressure and produced positive subjective effects in all the three groups .


It also increased ratings of attractiveness of another person and increased social interaction in RAP and OPP .


The social context affected certain responses to the drug .


The effects of MDMA were greater in the OPP condition , compared to the SOL or RAP conditions , on measures of `` feel drug , '' `` dizzy , '' and on cardiovascular .


But responses to the drug on other measures , including social behavior , did not differ across the conditions .


These findings provide some support for the idea that drugs produce greater effects when they are used in the presence of other drug users .


However , the influence of the social context was modest , and it remains to be determined whether other variables related to social context would substantially alter the effects of MDMA or other drugs .


Parenting programs based on cognitive-behavioral and social learning principles are effective in changing child behavior problems and parenting styles .


However , such programs typically have limited population reach .


The current study aimed to evaluate the efficacy of a brief radio series that provided parenting advice based on the Triple P-Positive Parenting Program .


One hundred thirty-nine parents of children aged 2 to 10 years who had concerns about their child 's behavioral and/or emotional adjustment were recruited , randomly assigned to either an intervention or waitlist control group , and completed online self-report measures .


Parents in the intervention group were given access to seven Triple P podcasts online over a period of 2 weeks .


Parents in the intervention group improved significantly more than parents in the control group , from pre - to postintervention , on measures of child behavioral problems and parenting style , self-efficacy , and confidence .


These short-term intervention effects were maintained at the 6-month follow-up .


These results suggest that brief radio and online parenting programs can be effective and have the potential to reach a large proportion of parents experiencing child behavior problems .


Limitations , clinical significance , and future research suggestions are discussed .


To observe the efficacy of preventing constipation by electroacupuncture intervention in ischemic stroke patients at acute stage .


Three hundred and forty ischemic stroke patients who matched the inclusive criteria were randomly divided into an electroacupuncture ( EA ) group and a routine treatment group , 170 cases in each one .


In the EA group , based on routine western treatment , rehabilitation training and common acupuncture , Tianshu ( ST 25 ) and Zusanli ( ST 36 ) were selected and connected to SDZ-V Hwato brand electric acupuncture apparatus respectively , given stimulation of dense-disperse wave ( 10 Hz/50 Hz ) with electric current of 0.1 to 1.0 mA , once every day and 5 times a week in the first 2 weeks , 2 times a week in the latter 2 weeks .


In the routine treatment group , only basic treatment was applied .


In the two groups , the course of treatment was 4 weeks and 8 weeks ' follow-up was required after treatment .


The actual numbers who independently defecated less than 3 times a week after 1 to 4 weeks ' treatment and in the 4th and the 8th weeks ' follow-up and condition taking laxative medicines during the 12 weeks in the two groups were observed and compared .


Compared on the numbers of constipation cases after 1 to 4 weeks ' treatment , those in the EA group were all less than those in the routine treatment group [ 24.7 % ( 42/170 ) vs. 36.5 % ( 62/170 ) , 18.8 % ( 32/170 ) vs. 30.6 % ( 52/170 ) , 10.5 % ( 17/162 ) vs. 27.5 % ( 44/160 ) , 9.3 % ( 15/162 ) vs. 19.4 % ( 31/160 ) , P < 0.05 , P < 0.001 ] .


In the 4th and the 8th weeks ' follow-up , numbers in the EA group were still less than those in the routine treatment group [ 9.0 % ( 14/156 ) vs. 18.1 % ( 28/155 ) , 7.7 % ( 12/155 ) vs. 16.9 ( 26/154 ) both P < 0.05 ) ] .


During the 12 weeks , the number of cases who took laxative medicines in the EA group was less than that in the routine treatment group [ 21.2 % ( 36/170 ) vs. 34.7 % ( 59/170 ) , P < 0.05 ] .


There is clinical significance to electroacupuncture at Tian-shui ( ST 25 ) and Zusanli ( ST 36 ) coibined with basic comprehensive treatment for preventing and treating constipation symptom in ischemic stroke acute stage .


To date , there are no known methods for preventing acute kidney injury after cardiac surgery .


Increasing evidence suggests that erythropoietin has renal antiapoptotic and tissue protective effects .


However , recent human studies have shown conflicting results .


The authors aimed to study the effect of a single high-dose erythropoietin preoperatively on renal function after coronary artery bypass grafting in patients with preoperative impaired renal function .


This single-center , randomized , double-blind , placebo-controlled study included 75 patients scheduled for coronary artery bypass grafting with preexisting renal impairment estimated glomerular filtration rate based on p-cystatin C ( < 60 and > 15 ml/min ) .


The patients either received a single high-dose erythropoietin ( 400 IU/kg ) or placebo preoperatively .


The primary endpoint was renal protection evaluated by p-cystatin C at the third postoperative day compared to the preoperative values .


Incidence of acute kidney injury and other renal biomarker changes were among secondary endpoints .


There was no statistically significant difference on the third postoperative day for relative p-cystatin C level changes from baseline between the groups , 131 31 % ( mean SD ) for the study group and 125 24 % for the control group ( P = 0.31 ; 95 % CI , -0.6 to 20 % for the difference ) .


There were no statistically significant differences in other renal biomarkers or measures between the groups ( p-neutrophil gelatinase-associated lipocalin , p-creatinine , p-urea , and estimated glomerular filtration rate ) .


There were no other differences in outcome variables between the groups .


Intravenous administration of a single high-dose ( 400 IU/kg ) erythropoietin did not have a renal protective effect on patients with reduced kidney function undergoing coronary artery bypass surgery .


Whether gender differences exist in procedure-related adverse events following cardiac resynchronization therapy ( CRT-D ) implantation is unknown .


We investigated the type and frequency of procedure-related adverse events among those enrolled in MADIT-CRT and identified clinical predictors for gender-specific events .


We compared differences in the rate of procedure-related adverse events by gender ( 444 females and 1,346 males ) that occurred 30 days after the index procedure in the implantable cardioverter defibrillator ( ICD ) and CRT-D groups .


Eight types of major adverse events were identified , defined as procedure-related complications deemed potentially life-threatening .


Best subset regression analysis ( P < 0.10 ) was performed to identify baseline clinical factors associated with procedure-related adverse events that differed by gender .


Women randomized to CRT-D received a greater reduction in the risk of heart failure or death versus men ( P < 0.001 ) .


Women were twice as likely as men to experience a major procedure-related adverse event ( 6.3 % vs. 2.7 % ; P < 0.001 ) , including pneumothorax/hemothorax ( 3 % vs. 1 % ; P < 0.001 ) .


Women were more likely to experience a major adverse event related to CRT-D than ICD implantation ( 7.7 % vs. 2.9 % ; P = 0.018 ) .


Clinical predictors of major adverse events in females were smaller body mass index ( BMI ) , elevated blood urea nitrogen , and elevated creatinine .


The main predictor for pneumothorax/hemothorax was reduced BMI for women and men .


Women demonstrate greater clinical benefit from CRT than men but are more likely to experience adverse procedure-related events within the first 30 days after device implantation .


A smaller BMI seems to be a major factor associated with pneumothorax/hemothorax in both females and males .


Dopaminergic medications relieve symptoms of the restless legs syndrome ( RLS ) but have the potential to cause iatrogenic worsening ( augmentation ) of RLS with long-term treatment .


Pregabalin may be an effective alternative .


In this 52-week , randomized , double-blind trial , we assessed efficacy and augmentation in patients with RLS who were treated with pregabalin as compared with placebo and pramipexole .


Patients were randomly assigned to receive 52 weeks of treatment with pregabalin at a dose of 300 mg per day or pramipexole at a dose of 0.25 mg or 0.5 mg per day or 12 weeks of placebo followed by 40 weeks of randomly assigned active treatment .


The primary analyses involved a comparison of pregabalin and placebo over a period of 12 weeks with use of the International RLS ( IRLS ) Study Group Rating Scale ( on which the score ranges from 0 to 40 , with a higher score indicating more severe symptoms ) , the Clinical Global Impression of Improvement scale ( which was used to assess the proportion of patients with symptoms that were `` very much improved '' or `` much improved '' ) , and a comparison of rates of augmentation with pregabalin and pramipexole over a period of 40 or 52 weeks of treatment .


A total of 719 participants received daily treatment , 182 with 300 mg of pregabalin , 178 with 0.25 mg of pramipexole , 180 with 0.5 mg of pramipexole , and 179 with placebo .


Over a period of 12 weeks , the improvement ( reduction ) in mean scores on the IRLS scale was greater , by 4.5 points , among participants receiving pregabalin than among those receiving placebo ( P < 0.001 ) , and the proportion of patients with symptoms that were very much improved or much improved was also greater with pregabalin than with placebo ( 71.4 % vs. 46.8 % , P < 0.001 ) .


The rate of augmentation over a period of 40 or 52 weeks was significantly lower with pregabalin than with pramipexole at a dose of 0.5 mg ( 2.1 % vs. 7.7 % , P = 0.001 ) but not at a dose of 0.25 mg ( 2.1 % vs. 5.3 % , P = 0.08 ) .


There were six cases of suicidal ideation in the group receiving pregabalin , three in the group receiving 0.25 mg of pramipexole , and two in the group receiving 0.5 mg of pramipexole .


Pregabalin provided significantly improved treatment outcomes as compared with placebo , and augmentation rates were significantly lower with pregabalin than with 0.5 mg of pramipexole .


( Funded by Pfizer ; ClinicalTrials.gov number , NCT00806026 . )


Poor sanitation is thought to be a major cause of enteric infections among young children .


However , there are no previously published randomized trials to measure the health impacts of large-scale sanitation programs .


India 's Total Sanitation Campaign ( TSC ) is one such program that seeks to end the practice of open defecation by changing social norms and behaviors , and providing technical support and financial subsidies .


The objective of this study was to measure the effect of the TSC implemented with capacity building support from the World Bank 's Water and Sanitation Program in Madhya Pradesh on availability of individual household latrines ( IHLs ) , defecation behaviors , and child health ( diarrhea , highly credible gastrointestinal illness [ HCGI ] , parasitic infections , anemia , growth ) .


We conducted a cluster-randomized , controlled trial in 80 rural villages .


Field staff collected baseline measures of sanitation conditions , behaviors , and child health ( May-July 2009 ) , and revisited households 21 months later ( February-April 2011 ) after the program was delivered .


The study enrolled a random sample of 5,209 children < 5 years old from 3,039 households that had at least one child < 24 months at the beginning of the study .


A random subsample of 1,150 children < 24 months at enrollment were tested for soil transmitted helminth and protozoan infections in stool .


The randomization successfully balanced intervention and control groups , and we estimated differences between groups in an intention to treat analysis .


The intervention increased percentage of households in a village with improved sanitation facilities as defined by the WHO/UNICEF Joint Monitoring Programme by an average of 19 % ( 95 % CI for difference : 12 % -26 % ; group means : 22 % control versus 41 % intervention ) , decreased open defecation among adults by an average of 10 % ( 95 % CI for difference : 4 % -15 % ; group means : 73 % intervention versus 84 % control ) .


However , the intervention did not improve child health measured in terms of multiple health outcomes ( diarrhea , HCGI , helminth infections , anemia , growth ) .


Limitations of the study included a relatively short follow-up period following implementation , evidence for contamination in ten of the 40 control villages , and bias possible in self-reported outcomes for diarrhea , HCGI , and open defecation behaviors .


The intervention led to modest increases in availability of IHLs and even more modest reductions in open defecation .


These improvements were insufficient to improve child health outcomes ( diarrhea , HCGI , parasite infection , anemia , growth ) .


The results underscore the difficulty of achieving adequately large improvements in sanitation levels to deliver expected health benefits within large-scale rural sanitation programs .


ClinicalTrials.gov NCT01465204 .


Please see later in the article for the Editors ' Summary .


Neonatal thrombocytopenia is a common and important clinical problem in preterm neonates .


A trial assessing clinically relevant outcomes in relation to the different platelet count thresholds used to trigger transfusion has never been undertaken in preterm neonates with severe thrombocytopenia .


Platelets for Neonatal Transfusion - Study 2 ( PlaNeT-2 ) aims to assess whether a higher prophylactic platelet transfusion threshold is superior to the lower thresholds in current standard practice in reducing the proportion of patients who have a major bleed or die up to study day 28 .


PlaNeT-2 is a two-stage , randomised , parallel-group , superiority trial .


PlaNet-2 compares clinical outcomes in preterm neonates ( < 34 weeks ' gestation at birth ) randomised to receive prophylactic platelet transfusions to maintain platelet counts at or above either 25 10 ( 9 ) / l or 50 10 ( 9 ) / l.


The primary outcome measure is the proportion of patients who either die or experience a major bleed up to and including study day 28 .


A total of 660 infants will be randomised .


This trial will help define optimal platelet transfusion support for severely thrombocytopenic preterm neonates by evaluating the risks and benefits of two different prophylactic neonatal platelet transfusion thresholds .


Higher dietary energy as protein during weight loss results in a greater loss of fat mass and retention of muscle mass ; however , the impact of protein quality on the rates of myofibrillar protein synthesis ( MPS ) and lipolysis , processes that are important in the maintenance of muscle and loss of fat , respectively , are unknown .


We aimed to determine how the consumption of different sources of proteins ( soy or whey ) during a controlled short-term ( 14-d ) hypoenergetic diet affected MPS and lipolysis .


Men ( n = 19 ) and women ( n = 21 ) ( age 35-65 y ; body mass index 28-50 kg/m ( 2 ) ) completed a 14-d controlled hypoenergetic diet ( -750 kcal/d ) .


Participants were randomly assigned , double blind , to receive twice-daily supplements of isolated whey ( 27 g/supplement ) or soy ( 26 g/supplement ) , providing a total protein intake of 1.3 0.1 g / ( kg d ) , or isoenergetic carbohydrate ( 25 g maltodextrin/supplement ) resulting in a total protein intake of 0.7 0.1 g / ( kg d ) .


Before and after the dietary intervention , primed continuous infusions of L - [ ring - ( 13 ) C6 ] phenylalanine and [ ( 2 ) H5 ] - glycerol were used to measure postabsorptive and postprandial rates of MPS and lipolysis .


Preintervention , MPS was stimulated more ( P < 0.05 ) with ingestion of whey than with soy or carbohydrate .


Postintervention , postabsorptive MPS decreased similarly in all groups ( all P < 0.05 ) .


Postprandial MPS was reduced by 9 1 % in the whey group , which was less ( P < 0.05 ) than the reduction in soy and carbohydrate groups ( 28 5 % and 31 5 % , respectively ; both P < 0.05 ) after the intervention .


Lipolysis was suppressed during the postprandial period ( P < 0.05 ) , but more so with ingestion of carbohydrate ( P < 0.05 ) than soy or whey .


We conclude that whey protein supplementation attenuated the decline in postprandial rates of MPS after weight loss , which may be of importance in the preservation of lean mass during longer-term weight loss interventions .


This trial was registered at clinicaltrials.gov as NCT01530646 .


We conducted a randomized , double-blind , placebo-controlled trial to evaluate the effect of ultrasound-guided corticosteroid injection in patients with ulnar neuropathy at the elbow ( UNE ) .


Fifty-five patients were randomized between an ultrasound-guided injection of 1 ml containing 40 mg methylprednisolone acetate and 10 mg lidocaine hydrochloride or a placebo injection .


The primary outcome was the subjective change of symptoms after 3 months .


The secondary outcomes were change in electrodiagnostic studies and ultrasonography findings .


A success rate of 30 % was found in the corticosteroid injection group versus 28 % in the placebo injection group .


Only the nerve cross-sectional area changed significantly in the intervention group , from a mean of 11.9 mm ( 2 ) to 10.9 mm ( 2 ) .


We could not demonstrate a positive effect of ultrasound-guided corticosteroid injection in UNE compared with placebo .


Favorable outcomes may be attributed to the natural course of UNE or the effect of patient education .


Little is known about the respective healing responses and clinical efficacy and safety of drug-eluting balloons ( DEB ) and the second generation of drug-eluting stents ( DES ) when used to treat in-stent restenosis ( ISR ) .


In this study , we set out to compare prospectively the healing characteristics , as assessed by optical coherence tomography ( OCT ) , of DEB versus DES after treatment of ISR in bare metal stents ( BMS ) .


Fifty patients with BMS ISR were randomised to treatment with a paclitaxel-eluting balloon vs. an everolimus-eluting stent ( EES ) .


The primary endpoint was the percentage of uncovered struts , assessed with OCT at nine months , as a marker of vessel wall healing .


A mean of 366135 and 636184 struts were analysed per patient in the DEB and EES groups , respectively .


The percentage of uncovered struts per patient was significantly lower with DEB vs. EES ( 1.4 % vs. 3.1 % , p = 0.025 ) .


Mean neointimal hyperplasia area was 2.41.08 mm in DEB vs. 1.920.67 mm in EES ( p = 0.1806 ) , while the percentage of malapposed struts per patient was very low in both groups ( 0.2 % vs. 0.3 % , p = 0.699 ) .


At nine months , angiographic in-stent MLD ( minimum lumen diameter ) was lower ( 2.13 vs. 2.54 mm , p = 0.006 ) , while diameter stenosis ( 26.4 vs. 11.4 % , p = 0.002 ) , and LLL ( 0.28 vs. 0.07 mm , p = 0.1 ) were higher after DEB compared to EES .


During one-year follow-up , we did not observe differences in the rates of death , TLR ( target lesion revascularisation ) or stent thrombosis .


DEB appears to be associated with better healing characteristics , as assessed by stent strut coverage with OCT , but tended to be slightly less effective compared to EES .


These findings give support to the use of either DEB or EES as valuable treatment options for ISR .


http://www.clinicaltrials.gov .


Unique identifier : NCT 01065532 .


The aim of this study was to assess if the consumption of 3g of a commercially available L-arginine dietary supplement causes a postabsorptive rise in urea concentration or pH of unstimulated saliva in a group of physically active individuals .


Salivary urea and pH were determined for 117 participants in a randomized double-blinded placebo-controlled study .


Samples were collected by ` spitting ' method in fasting conditions .


One hour prior to their second visit , participants consumed three tablets of L-arginine or placebo .


Urea concentration was significantly lower at second measurement for both the study and control group .


The magnitude of the change was not significant between the groups .


pH was higher for both groups at second measurement , but only significant for the study group .


The magnitude of the change was significant between the groups .


Participants who intermittently ingested protein dietary supplements and those with a Body Mass Index ( BMI ) higher than 25 had significantly higher basal urea concentration .


The results of this study did not confirm the hypothesis .


Further studies are needed to determine the effects of different doses of L-arginine supplements on the biochemical composition of saliva and the influence of their long-term consumption on the risk of developing dental diseases .


Several studies suggest that a healthy diet with high emphasis on nutritious , low-energy components such as fruits , vegetables , and seafood tends to be more costly for consumers .


Derived from the ideas from the New Nordic Cuisine -- and inspired by the Mediterranean diet , the New Nordic Diet ( NND ) has been developed as a palatable , healthy and sustainable diet based on products from the Nordic region .


The objective of the study is to investigate economic consequences for the consumers of the NND , compared with an Average Danish Diet ( ADD ) .


Combine quantity data from a randomized controlled ad libitum dietary 6 month intervention for central obese adults ( 18-65 years ) and market retail price data of the products consumed in the intervention .


Adjust consumed quantities to market price incentives using econometrically estimated price elasticities .


Average daily food expenditure of the ADD as represented in the unadjusted intervention ( ADD-i ) amounted to 36.02 DKK for the participants .


The daily food expenditure in the unadjusted New Nordic Diet ( NND-i ) costs 44.80 DKK per day per head , and is hence about 25 % more expensive than the Average Danish Diet ( or about 17 % when adjusting for energy content of the diet ) .


Adjusting for price incentives in a real market setting , the estimated cost of the Average Danish Diet is reduced by 2.50 DKK ( ADD-m ) , compared to the unadjusted ADD-i diet , whereas the adjusted cost of the New Nordic Diet ( NND-m ) is reduced by about 3.50 DKK , compared to the unadjusted NND-i .


The distribution of food cost is however much more heterogeneous among consumers within the NND than within the ADD .


On average , the New Nordic Diet is 24-25 per cent more expensive than an Average Danish Diet at the current market prices in Denmark ( and 16-17 per cent , when adjusting for energy content ) .


The relatively large heterogeneity in food costs in the NND suggests that it is possible to compose an NND where the cost exceeds that of ADD by less than the 24-25 per cent .


To investigate the effectiveness of a 6-month Liuzijue qigong ( LQG ) program in promoting physical and psychosocial function in individuals with chronic obstructive pulmonary disease ( COPD ) .


Single-blind , randomized controlled trial .


Seven hospital respiratory care centers in Beijing .


Individuals with COPD ( N = 126 ; mean age 71.1 2.7 , range 65-85 ) .


Participants were randomly assigned to one of two groups : LQG ( n = 63 ) and control ( n = 63 ) .


Subjects in the LQG group received a LQG program consisting of four 45-minute sessions each week and daily walking for 30 minutes for 6 months .


Control subjects walked daily for 30 minutes .


Data collection was performed at baseline , at 6 weeks , and at 6 months .


Primary outcomes involved functional capacity , and secondary outcomes involved quality of life .


The LQG group had greater improvements in the 6-minute walk test ( P = .02 ) ; specific airway conductance ( P = .02 ) ; monitored functional task evaluation ( P = .04 ) ; Medical Outcomes Study 36-item Short-Form Health Survey ( SF-36 ; general health ( P < .001 ) , mental health ( P = .03 ) ) ; Chronic Respiratory Questionnaire ( dyspnea ( P = .05 ) , emotion ( P = .05 ) , and mastery ( P = .04 ) at 6-month follow-up .


After 6 months , the control group had significant improvement only on the SF-36 mental health ( P = .02 ) .


LQG promoted functional capacity and quality of life in older adults with COPD at 6 months and is a good alternative home exercise program for older adults in the rehabilitation of COPD .


Inflammation impairs cognitive performance and is implicated in the progression of neurodegenerative disorders .


Rodent studies demonstrated key roles for inflammatory mediators in many processes critical to memory , including long-term potentiation , synaptic plasticity , and neurogenesis .


They also demonstrated functional impairment of medial temporal lobe ( MTL ) structures by systemic inflammation .


However , human data to support this position are limited .


Sequential fluorodeoxyglucose positron emission tomography together with experimentally induced inflammation was used to investigate effects of a systemic inflammatory challenge on human MTL function .


Fluorodeoxyglucose positron emission tomography scanning was performed in 20 healthy participants before and after typhoid vaccination and saline control injection .


After each scanning session , participants performed a virtual reality spatial memory task analogous to the Morris water maze and a mirror-tracing procedural memory control task .


Fluorodeoxyglucose positron emission tomography data demonstrated an acute reduction in human MTL glucose metabolism after inflammation .


The inflammatory challenge also selectively compromised human spatial , but not procedural , memory ; this effect that was independent of actions on motivation or psychomotor response .


Effects of inflammation on parahippocampal and rhinal glucose metabolism directly mediated actions of inflammation on spatial memory .


These data demonstrate acute sensitivity of human MTL to mild peripheral inflammation , giving rise to associated functional impairment in the form of reduced spatial memory performance .


Our findings suggest a mechanism for the observed epidemiologic link between inflammation and risk of age-related cognitive decline and progression of neurodegenerative disorders including Alzheimer 's disease .


Duration of bladder catheterisation after female genital fistula repair varies widely .


We aimed to establish whether 7 day bladder catheterisation was non-inferior to 14 days in terms of incidence of fistula repair breakdown in women with simple fistula .


In this randomised , controlled , open-label , non-inferiority trial , we enrolled patients at eight hospitals in the Democratic Republic of the Congo , Ethiopia , Guinea , Kenya , Niger , Nigeria , Sierra Leone , and Uganda .


Consenting patients were eligible if they had a simple fistula that was closed after surgery and remained closed 7 days after surgery , understood study procedures and requirements , and agreed to return for follow-up 3 months after surgery .


We excluded women if their fistula was not simple or was radiation-induced , associated with cancer , or due to lymphogranuloma venereum ; if they were pregnant ; or if they had multiple fistula .


A research assistant at each site randomly allocated participants 1:1 ( randomly varying block sizes of 4-6 ; stratified by country ) to 7 day or 14 day bladder catheterisation ( via a random allocation sequence computer generated centrally by WHO ) .


Outcome assessors were not masked to treatment assignment .


The primary outcome was fistula repair breakdown , on the basis of dye test results , any time between 8 days after catheter removal and 3 months after surgery .


The non-inferiority margin was 10 % , assessed in the per-protocol population .


This trial is registered with ClinicalTrials.gov , number NCT01428830 .


We randomly allocated 524 participants between March 7 , 2012 , and May 6 , 2013 ; 261 in the 7 day group and 263 in the 14 day group .


In the per-protocol analysis , ten ( 4 % ) of 250 patients had repair breakdown in the 7 day group ( 95 % CI 2-8 ) compared with eight ( 3 % ) of 251 ( 2-6 ) in the 14 day group ( risk difference 08 % [ 95 % CI -28 to 45 ] ) , meeting the criteria for non-inferiority .


7 day bladder catheterisation after repair of simple fistula is non-inferior to 14 day catheterisation and could be used for management of women after repair of simple fistula with no evidence of a significantly increased risk of repair breakdown , urinary retention , or residual incontinence up to 3 months after surgery .


US Agency for International Development .


To compare the efficacy difference in treatment of borderline hypertension between acupuncture combined with anti-hypertensive plaster and simple acupuncture .


Sixty patients of borderline hypertension were randomized into an observation group and a control group , 30 cases in each one .


In the observation group , acupuncture was applied to Fengchi ( GB 20 ) , Taichong ( LR 3 ) and the others , once a day , 5 treatments made one session .


There were 2 days at interval among the sessions .


Totally , 4 sessions were required .


Additionally , in combination , the anti-hypertensive plaster was prepared with the fine powder of Chuanxiong ( ligusticum wallichii ) and Wuzhuyu ( fructus evodiae ) at 1.1 and mixed with vinegar .


The plaster was applied to the umbilicus , once every two days , totally 15 times were required .


In the control group , acupuncture was given simply .


The selected acupoints and operation were the same as the observation group .


Before and after treatment , blood pressure and syndrome score were observed and the short-term and long-term efficacies were assessed in the two groups .


After treatment , the systolic pressure and diastolic pressure were reduced as compared with those before treatment in the two groups ( all P < 0.001 ) , and the differences were significant in comparison between the observation group and the control group ( P < 0.01 , P < 0.05 ) .


The syndrome score after treatment was reduced as compared with that before treatment in the two groups ( both P < 0.001 ) and the difference was not significant in comparison between the two groups ( P > 0.05 ) .


In follow-up of the effective cases and remarkably effective cases in 3 months , the total effective rate in the observation group was 89.3 % ( 25/28 ) and was 60.0 % ( 15/25 ) in the control group , indicating the significant difference in comparison ( P < 0.05 ) .


Acupuncture combined with anti-hypertensive plaster is the effective method in prevention and treatment of borderline hypertension .


Regarding the long-term efficacy , this combined therapy achieves the superior improvement in the symptoms and physical signs of the patients of borderline hypertension as compared with simple acupuncture .


Anticoagulation for the haemodialysis circuit in patients treated with oral anticoagulation poses additional haemorrhagic risk .


The few available data suggest that tapering or even stopping heparinization is feasible and the HeprAN membrane with grafted heparin was developed to decrease heparin dose .


The objective of our study was to evaluate the need for additional anticoagulation in patients on long-term oral anticoagulation , according to the type of membrane used .


This is a prospective , randomized , crossover bifactorial trial in haemodialysed patients on oral anticoagulation .


Each patient had four haemodialysis sessions with two different membranes [ HeprAN or polysulphone ( PS ) ] and with or without enoxaparin .


Clinical coagulation was evaluated by the need for premature ending and by a visual score ( Janssen scale ) .


Coagulation activation markers were also measured : d-dimers , prothrombin fragments 1 + 2 , thrombin-antithrombin complexes , tissue factor pathway inhibitor and platelet factor-4 .


Ten patients were included ( M/F = 4/6 , mean age 63 15 years ) .


None of the 40 sessions ended prematurely .


The clotting scores were similar with or without enoxaparin ( dialyser : 1.49 0.19 versus 1.53 0.17 , P = 0.97 ; bubble trap : 0.75 0.19 versus 0.78 0.22 , P = 0.62 ) and with the polysulphone or the HeprAN membrane ( dialyser : 1.54 0.20 versus 1.47 0.16 , P = 0.65 ; bubble trap : 0.74 0.22 versus 0.79 0.19 , P = 0.58 ) .


There was no significant difference in coagulation activation markers between dialysis modalities ; however , dialysis efficacy was significantly greater with the PS membrane ( 1.58 0.07 versus 1.43 0.06 , P = 0.02 ) .


These results suggest that haemodialysis without additional anticoagulation is possible in patients with oral anticoagulation .


The HeprAN membrane did not provide any additional benefit compared with a PS membrane .


In forensic settings , individuals who experience a traumatic event are often encouraged to recall it soon afterwards to preserve their memory for it .


Some theories of the development of post-traumatic stress disorder ( PTSD ) suggest that this may increase psychopathology .


The primary aim of the study was to examine the effect of immediate recall of a trauma analogue video on psychopathology .


Eighty-five undergraduate students were randomised to view a video of a car accident , described as either a real event ( high stress ) or training event ( low stress ) .


They then completed either the Self-Administered Interview ( SAI , Gabbert , Hope , & Fisher , 2009 ) or a filler task .


All participants returned one week later to provide an account of the event .


As predicted , participants in the SAI early recall task condition remembered the video content better one week after seeing the video , shown both by their greater recall of correct details and greater rejection of misinformation .


However , completing the SAI resulted in higher anxiety immediately afterwards , and more severe PTSD-like symptoms one week later , compared to control condition .


PTSD intrusion-like symptoms also predicted more accurate recall , while avoidance predicted poorer memory .


While the trauma analogue video used in this study has been previously used , and did effectively trigger post-traumatic-like symptoms , it is unclear how well these results generalise to actual trauma situations .


These results suggest the relationship between PTSD symptoms and memory might be more complex than previously recognised , with intrusive phenomena possibly promoting memory and avoidance symptoms compromising memory .


The study explores whether messages about the physical activity levels of the majority ( i.e. normative messages ) affect young adults ' intention to engage in regular physical activity .


An experimental survey among 16 to 24 year-olds in Bulgaria , Croatia and Romania ( n = 1200 ) was conducted in March 2013 .


A control group received no message ; one treatment group was told that the majority was physically active ( positive message ) ; and another treatment group was told that the majority was not physically active ( negative message ) .


Both the positive and ( unexpectedly ) the negative normative messages showed a significant and positive effect on intention to be physically active .


There was no difference between the effects of the messages .


Normative messages affect intention , which is encouraging for public health campaigns .


The effect of the positive message confirms previous findings on conformity to the norm ; the effect of the negative message is unexpected and requires further research to be understood .