The study was powered a priori at 90 % to detect a difference in walking speed of 0.1 m/second , which was considered a clinically important difference , and in a post hoc analysis at 80 % to detect a difference of 10 points in KSS .


There were improvements from preoperatively to 3 months postoperatively in functional scores , QOL , and knee kinematic and kinetic gait parameters during level walking .


However , there was no difference between the patient-specific instrumentation and conventional instrumentation groups in KSS , KOOS , SF-12 , or 3-D gait parameters .


Our observations suggest that patient-specific instrumentation does not confer a substantial advantage in early functional or gait outcomes after TKA .


It is possible that differences may emerge , and this study does not allow one to predict any additional variances in the intermediate followup period from 6 months to 1 year postoperatively .


However , the goals of the study were to investigate the recovery period as early pain and functional outcomes are becoming increasingly important to patients and surgeons .


Level I , therapeutic study .


See the Instructions to Authors for a complete description of levels of evidence .


Inadequate bowel cleaning leads to a suboptimal colonoscopic examination .


Gum chewing has been reported to have a favorable effect on postoperative bowel functions .


We conducted this study to establish if gum chewing added to high-dose senna before colonoscopy promotes bowel cleaning .


In this randomized controlled study , consecutive outpatients scheduled for elective colonoscopy were randomized into two groups .


Group 1 patients ( n = 65 ) used senna solution 150 mL ( 300 mg senna ) the night before colonoscopy .


The patients also used sennoside tablet 80 mg daily for 3 days before the colonoscopy .


Patients in group 2 ( n = 64 ) were additionally advised to chew sugarless gum half an hour three-times daily after meals for these 3 days .


The overall quality of colonoscopy cleaning was evaluated using the Aronchick scale by a single endoscopist who was blinded to the intervention .


Difficulty of procedure , patients ' tolerance , and adverse events were also evaluated .


A total 129 patients were enrolled in the study .


Superior cleaning was found in gum chewing group when compared with other group particularly in the cecum and ascending colon .


Cecal intubation time was significantly shorter in the gum-chewing group ( 8.6 5.1 and 7.1 2.8 min , P = 0.03 ) .


Adverse events were more common in group 1 compared to the gum-chewing group .


Gum chewing enhances colonoscopy bowel preparation quality .


Moreover , it is a physiologically sound , safe , and an inexpensive part of the colonoscopy bowel preparation .


Gum chewing could be advised in addition to high-dose senna containing bowel preparation .


Individuals with borderline personality disorder ( BPD ) and comorbid post-traumatic stress disorder ( PTSD ) have a worse prognosis than individuals with BPD alone .


A common view is that the emotional instability and impulsivity of BPD should be treated before attempting to address trauma .


However , PTSD symptoms may interfere with patients ' ability to benefit from such ` stabilizing ' treatments .


The effect of BPD-PTSD comorbidity on self-harm and BPD symptom outcomes was evaluated in 89 patients receiving dialectical behaviour therapy , using multilevel modelling .


Patients with comorbid BPD-PTSD showed a trend towards elevated BPD symptoms throughout the treatment year ( = 2.12 , 95 % CI = -0.21 -4.44 , p = 0.07 ) .


There was a three-way interaction between PTSD comorbidity , treatment completion and time , whereby PTSD comorbidity was associated with less reduction in self-harm frequency over time , but only in those completing the full 12 months of treatment ( incident risk ratio = 1.16 , 95 % CI = 1.04-1 .30 , p < 0.01 ) .


Patients with comorbid PTSD had a poorer outcome from dialectical behaviour therapy than those with BPD alone , possibly because of the negative impact of unaddressed trauma .


The results provide further grounds for recently developed treatments targeting BPD traits and PTSD symptoms simultaneously .


Response-dose ratio ( RDR ) and cumulative provocative dosage ( PD ) are useful indices reflecting airway responsiveness in asthma .


To compare the diagnostic value of RDR and PD , by conducting leukotriene D4 ( LTD4-BPT ) and methacholine bronchial provocation test ( MCh-BPT ) , in different asthma control levels .


Healthy subjects and asthmatic patients underwent LTD4-BPT and MCh-BPT , at 2-14-day interval .


This entailed assessment of the distribution characteristics , correlation , and diagnostic value of PD inducing 20 % fall in forced expiratory volume in one second ( PD20FEV1 ) and the RDR , defined as FEV1 fall ( % ) at the final step divided by the corresponding provocative dosage .


Twenty uncontrolled , 22 partly controlled , 20 controlled asthmatics , and 21 healthy subjects were enrolled .


Log10RDR was positively correlated with log10PD20FEV1 in both BPTs ( all P < 0.05 ) .


Poorer asthma control was associated with significantly lower PD20FEV1 and higher RDR ( both P < 0.05 ) .


The differences in PD20FEV1 and RDR between partly controlled and controlled asthma were unremarkable ( both P > 0.05 ) .


Compared with log10PD20FEV1 , the log10RDR yielded similar diagnostic values in both BPTs .


A lower percentile of RDR ( 25th percentile ) was associated with higher baseline FEV1 ( P < 0.05 ) and an increased proportion of well-controlled asthmatic patients .


The combination of RDR and PD20FEV1 led to an increased diagnostic value compared with either parameter alone .


RDR is a surrogate of PD20FEV1 for BPTs in asthma .


This finding was not modified by different asthma control levels or the types of bronchoprovocants .


In a previous randomized trial , we found that percutaneous coronary intervention ( PCI ) was not inferior to coronary artery bypass grafting ( CABG ) for the treatment of unprotected left main coronary artery stenosis at 1 year .


This study sought to determine the 5-year outcomes of PCI compared with CABG for the treatment of unprotected left main coronary artery stenosis .


We randomly assigned 600 patients with unprotected left main coronary artery stenosis to undergo PCI with a sirolimus-eluting stent ( n = 300 ) or CABG ( n = 300 ) .


The primary endpoint was a major adverse cardiac or cerebrovascular event ( MACCE : a composite of death from any cause , myocardial infarction , stroke , or ischemia-driven target vessel revascularization ) and compared on an intention-to-treat basis .


At 5 years , MACCE occurred in 52 patients in the PCI group and 42 patients in the CABG group ( cumulative event rates of 17.5 % and 14.3 % , respectively ; hazard ratio [ HR ] : 1.27 ; 95 % confidence interval [ CI ] : 0.84 to 1.90 ; p = 0.26 ) .


The 2 groups did not differ significantly in terms of death from any cause , myocardial infarction , or stroke as well as their composite ( 8.4 % and 9.6 % ; HR , 0.89 ; 95 % CI , 0.52 to 1.52 ; p = 0.66 ) .


Ischemia-driven target vessel revascularization occurred more frequently in the PCI group than in the CABG group ( 11.4 % and 5.5 % , respectively ; HR : 2.11 ; 95 % CI : 1.16 to 3.84 ; p = 0.012 ) .


During 5 years of follow-up , our study did not show significant difference regarding the rate of MACCE between patients who underwent PCI with a sirolimus-eluting stent and those who underwent CABG .


However , considering the limited power of our study , our results should be interpreted with caution .


( Bypass Surgery Versus Angioplasty Using Sirolimus-Eluting Stent in Patients With Left Main Coronary Artery Disease [ PRECOMBAT ] ; NCT00422968 ) .


To evaluate 3 - and 6-month weight-loss outcomes achieved when physicians refer overweight/obese patients to an automated 3-month Internet-based behavioral weight-loss intervention .


A total of 154 patients age 18-70 years with a BMI between 25 and 45 kg/m ( 2 ) and access to a personal computer and the Internet were randomly assigned to 3 months of Internet behavioral intervention ( IBI ; n = 77 ) with 12 weekly videos teaching behavioral weight-loss skills , a platform for submitting self-monitored data , and automated feedback or an education-only Internet-delivered eating and activity control group ( IDEA ; n = 77 ) .


Outcome measures were weight loss after 3 months ( primary outcome ) and 6 months and changes in weight-control behaviors ( secondary outcomes ) .


In intent-to-treat analyses with baseline weight carried forward for missing data , IBI produced significantly larger mean ( SD ) weight losses than IDEA at 3 months ( 5.5 kg [ 4.4 ] vs. 1.3 kg [ 2.1 ] ) and 6 months ( 5.4 kg [ 5.6 ] vs. 1.3 kg [ 4.1 ] ) ( P < 0.001 ) .


Participants in IBI compared with IDEA were also more likely to achieve a clinically significant weight loss of 5 % of initial body weight at 3 months ( 53.3 vs. 9.1 % ) and 6 months ( 48.1 vs. 15.6 % ) ( P < 0.001 ) and reported more frequent use of weight control-related strategies .


Physician referral to an Internet-based behavioral weight-loss intervention produced clinically significant weight loss for over half of the patients studied .


Further research is needed to determine the effectiveness of implementing this intervention more broadly within diverse health care settings .


We aimed to determine the effects of treatment with intravenous immunoglobulin on bacterial infections in patients with hypogammaglobulinemia ( HGG ) after lung transplantation .


We performed a randomized , double-blind , placebo-controlled two-period crossover trial of immune globulin intravenous ( IVIG ) , 10 % Purified ( Gamunex , Bayer , Elkhart , IN ) monthly in eleven adults who had undergone lung transplantation more than three months previously .


We randomized study participants to three doses of IVIG ( or 0.1 % albumin solution ( placebo ) ) given four weeks apart followed by a twelve week washout and then three doses of placebo ( or IVIG ) .


The primary outcome was the number of bacterial infections within each treatment period .


IVIG had no effect on the number of bacterial infections during the treatment period ( 3 during IVIG and 1 during placebo ; odds ratio 3.5 , 95 % confidence interval 0.4 to 27.6 , p = 0.24 ) .


There were no effects on other infections , use of antibiotics , or lung function .


IVIG significantly increased trough IgG levels at all time points ( least square means , 765.3 mg/dl during IVIG and 486.3 mg/dl during placebo , p < 0.001 ) .


Four serious adverse events ( resulting in hospitalization ) occurred during the treatment periods ( 3 during active treatment and 1 during the placebo period , p = 0.37 ) .


Chills , flushing , and nausea occurred during one infusion of IVIG .


Treatment with IVIG did not reduce the short-term risk of bacterial infection in patients with HGG after lung transplantation .


The clinical efficacy of immunoglobulin supplementation in HGG related to lung transplantation over the long term or with recurrent infections is unknown .


Clinicaltrials.gov NCT00115778 .


Colorectal cancer ( CRC ) is the fourth leading cause of cancer-related deaths worldwide .


The combination of oxaliplatin-based treatments ( oxaliplatin plus infusional 5-fluorouracil and leucovorin [ FOLFOX ] or oxaliplatin plus capecitabine [ CapeOX ] ) and bevacizumab is a standard chemotherapy regimen for metastatic CRC ( mCRC ) .


However , several clinical studies that tested S-1 plus oxaliplatin ( SOX ) indicate that SOX is also a treatment option for mCRC .


TSU-68 is an oral compound that inhibits vascular endothelial growth factor receptor and platelet-derived growth factor receptor .


The recommended dose of TSU-68 + SOX was previously determined in a phase I study of mCRC patients .


The goal of this trial was to evaluate the efficacy of TSU-68 in combination with SOX .


This open-label multicenter randomized phase II trial was performed in Korea .


Treatment-naive mCRC patients with a performance status of 0 or 1 were randomized in a 1:1 ratio to receive either TSU-68 + SOX or SOX alone .


The primary endpoint was progression-free survival ( PFS ) .


A total of 105 patients ( TSU-68 + SOX , 52 patients ; SOX alone , 53 patients ) were randomized .


The median PFS was 7.0 months in the TSU-68 + SOX group ( hazard ratio [ HR ] , 1.057 ) and 7.2 months in the SOX group ( p = 0.8401 ) .


The most frequent grade 3 and 4 adverse events were thrombocytopenia ( 9.6 % [ TSU-68 + SOX ] vs. 26.4 % [ SOX ] ) , neutropenia ( 13.5 % [ TSU-68 + SOX ] vs. 15.1 % [ SOX ] ) , and anemia ( 3.8 % [ TSU-68 + SOX ] vs. 13.2 % [ SOX ] ) .


We observed a difference between the 2 groups for all grades of anemia ( 15.4 % [ TSU-68 + SOX ] vs. 32.1 % [ SOX ] ) , diarrhea ( 30.8 % [ TSU-68 + SOX ] vs. 47.2 % [ SOX ] ) , vomiting ( 50.0 % [ TSU-68 + SOX ] vs. 26.4 % [ SOX ] ) , and chromaturia ( 23.1 % [ TSU-68 + SOX ] vs. 0.0 % [ SOX ] ) .


Analysis using a Cox proportional hazard model showed that baseline interleukin 6 ( IL-6 ) levels were associated with a survival benefit of TSU-68 ( p = 0.012 ) .


TSU-68 + SOX had a favorable safety profile .


However , TSU-68 did not have a synergistic effect on the efficacy of SOX .


The baseline serum IL-6 level could be a prognostic factor for TSU-68 efficacy .


This prospective , observer-blinded , randomised , multicentre study aimed at determining the non-inferiority of 50 mg of plain 1 % 2-chloroprocaine vs. 10 mg of 0.5 % plain bupivacaine in terms of sensory block onset time at T10 after spinal injection .


The study hypothesis was that the difference in onset times of sensory block to T10 between the two drugs is 4 min .


One hundred and thirty patients undergoing lower abdominal or lower limb procedures ( 40 min ) were randomised to receive one of two treatments : 50 mg of plain 1 % 2-chloroprocaine ( Group C , n = 66 ) or 10 mg of plain 0.5 % bupivacaine ( Group B , n = 64 ) .


Times to sensory and motor block onsets , maximum sensory block level , readiness for surgery , regression of sensory and motor blocks , first analgesic requirements , unassisted ambulation , home discharge , and side effects after 24 h and 7 days were registered blindly .


Chloroprocaine was comparable with plain 0.5 % bupivacaine in terms of time to sensory block at T10 level .


Group C showed faster onsets of motor block ( 5 vs. 6 min ) , maximum sensory block level ( 8.5 vs. 14 min ) , resolution of sensory ( 105 vs. 225 min ) and motor ( 100 vs. 210 min ) blocks , unassisted ambulation ( 142.5 vs. 290.5 min ) , first analgesic requirement ( 120 vs. 293.5 min ) , and home discharge ( 150 vs. 325 min ) ( all comparisons , P < 0.05 ) .


No chloroprocaine patient developed transient neurological symptoms .


Spinal anaesthesia with 50 mg of plain 1 % 2-chloroprocaine is similar to 10 mg of plain 0.5 % bupivacaine in terms of onset of sensory block at T10 but shows quicker recovery from anaesthesia than with 0.5 % bupivacaine .


To evaluate the long-term safety and efficacy of prolonged-release oxycodone/naloxone ( OXN PR ) and its impact on quality of life ( QoL ) , in patients with moderate-to-severe cancer pain .


This was an open-label extension ( OLE ) of a 4 week , randomized , double-blind ( DB ) study in which patients with moderate-to-severe cancer pain had been randomized to OXN PR or oxycodone PR ( OxyPR ) .


During the OLE phase , patients were treated with OXN PR capsules ( 20/60 mg/day ) for 24 weeks .


Outcome measures included safety , efficacy and QoL .


One hundred and twenty-eight patients entered the OLE , average pain scores based on the modified Brief Pain Inventory-Short Form were low and stable over the 24-week period .


The improvement in bowel function and constipation symptoms as measured by the Bowel Function Index and patient assessment of constipation in patients treated with OXN PR during the 4-week DB study was maintained .


In patients treated with OxyPR during the DB phase , bowel function and constipation symptoms were improved during the OLE .


In the DB and in the OLE , health status and QoL were similar for patients treated with OXN PR and OxyPR .


There were no unexpected safety or tolerability issues .


In patients with moderate-to-severe cancer pain , long-term use of OXN PR is well tolerated and effective , resulting in sustained analgesia , improved bowel function and improved symptoms of constipation .


Research to assess the effect of interventions to improve the processes of shared decision making and self-management directed at health care professionals is limited .


Using the protocol of Intervention Mapping , a Web-based intervention directed at health care professionals was developed to complement and optimize health services in patient-centered care .


The objective of the Web-based intervention was to increase health care professionals ' intention and encouraging behavior toward patient self-management , following cardiovascular risk management guidelines .


A randomized controlled trial was used to assess the effect of a theory-based intervention , using a pre-test and post-test design .


The intervention website consisted of a module to help improve professionals ' behavior , a module to increase patients ' intention and risk-reduction behavior toward cardiovascular risk , and a parallel module with a support system for the health care professionals .


Health care professionals ( n = 69 ) were recruited online and randomly allocated to the intervention group ( n = 26 ) or ( waiting list ) control group ( n = 43 ) , and invited their patients to participate .


The outcome was improved professional behavior toward health education , and was self-assessed through questionnaires based on the Theory of Planned Behavior .


Social-cognitive determinants , intention and behavior were measured pre-intervention and at 1-year follow-up .


The module to improve professionals ' behavior was used by 45 % ( 19/42 ) of the health care professionals in the intervention group .


The module to support the health professional in encouraging behavior toward patients was used by 48 % ( 20/42 ) .


The module to improve patients ' risk-reduction behavior was provided to 44 % ( 24/54 ) of patients .


In 1 of every 5 patients , the guideline for cardiovascular risk management was used .


The Web-based intervention was poorly used .


In the intervention group , no differences in social-cognitive determinants , intention and behavior were found for health care professionals , compared with the control group .


We narrowed the intervention group and no significant differences were found in intention and behavior , except for barriers .


Results showed a significant overall difference in barriers between the intervention and the control group ( F1 = 4.128 , P = .02 ) .


The intervention was used by less than half of the participants and did not improve health care professionals ' and patients ' cardiovascular risk-reduction behavior .


The website was not used intensively because of time and organizational constraints .


Professionals in the intervention group experienced higher levels of barriers to encouraging patients , than professionals in the control group .


No improvements were detected in the processes of shared decision making and patient self-management .


Although participant education level was relatively high and the intervention was pre-tested , it is possible that the way the information was presented could be the reason for low participation and high dropout .


Further research embedded in professionals ' regular consultations with patients is required with specific emphasis on the processes of dissemination and implementation of innovations in patient-centered care .


Netherlands Trial Register Number ( NTR ) : NTR2584 ; http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=2584 ( Archived by WebCite at http://www.webcitation.org/6STirC66r ) .


Although high-dose N-acetylcysteine ( NAC ) has been suggested to reduce COPD exacerbations , it is unclear which category of patients with COPD would benefit most from NAC treatment .


The objective of this study was to compare the effect of high-dose NAC ( 600 mg bid ) between high-risk and low-risk Chinese patients with COPD .


Patients with spirometry-confirmed stable COPD were randomized to treatment with either NAC 600 mg bid or placebo in addition to their usual treatments .


Patients were followed up every 16 weeks for a total of 1 year .


Further analysis was performed according to each patient 's exacerbation risk at baseline as defined by the current GOLD ( Global Initiative for Chronic Obstructive Lung Disease ) strategy to analyze the effect of high-dose NAC in high-risk and low-risk patients .


Of the 120 patients with COPD randomized ( men , 93.2 % ; mean age , 70.8 0.74 years ; prebronchodilator FEV , 53.9 2.0 % ; baseline characteristics comparable between treatment groups ) , 108 ( NAC , 52 ; placebo , 56 ) completed the 1-year study .


For high-risk patients ( n = 89 ) , high-dose NAC compared with placebo significantly reduced exacerbation frequency ( 0.85 vs 1.59 [ P = .019 ] and 1.08 vs 2.22 [ P = .04 ] at 8 and 12 months , respectively ) , prolonged time to first exacerbation ( P = .02 ) , and increased the probability of being exacerbation free at 1 year ( 51.3 % vs 24.4 % , P = .013 ) .


This beneficial effect of high-dose NAC vs placebo was not significant in low-risk patients .


High-dose NAC ( 600 mg bid ) for 1 year reduces exacerbations and prolongs time to first exacerbation in high-risk but not in low-risk Chinese patients with COPD .


ClinicalTrials.gov ; No. : NCT01136239 ; URL : www.clinicaltrials.gov .


Evidence-based preventive services for early detection of cancer and other health conditions offer profound health benefits , yet Americans receive only half of indicated services .


Policy initiatives promote the adoption of information technologies to engage patients in care .


We developed a theory-driven interactive preventive health record ( IPHR ) to engage patients in health promotion .


The model defines five levels of functionality : ( 1 ) collecting patient information , ( 2 ) integrating with electronic health records ( EHRs ) , ( 3 ) translating information into lay language , ( 4 ) providing individualized , guideline-based clinical recommendations , and ( 5 ) facilitating patient action .


It is hypothesized that personal health records ( PHRs ) with these higher levels of functionality will inform and activate patients in ways that simpler PHRs can not .


However , realizing this vision requires both technological advances and effective implementation based upon clinician and practice engagement .


We are starting a two-phase , mixed-method trial to evaluate whether the IPHR is scalable across a large number of practices and how its uptake differs for minority and disadvantaged patients .


In phase 1 , 40 practices from three practice-based research networks will be randomized to add IPHR functionality to their PHR versus continue to use their existing PHR .


Throughout the study , we will engage intervention practices to locally tailor IPHR content and learn how to integrate new functions into their practice workflow .


In phase 2 , the IPHR to all nonintervention practices to observe whether the IPHR can be implemented more broadly ( Scalability ) .


Phase 1 will feature an implementation assessment in intervention practices , based on the RE-AIM model , to measure Reach ( creation of IPHR accounts by patients ) , Adoption ( practice decision to use the IPHR ) , Implementation ( consistency , fidelity , barriers , and facilitators of use ) , and Maintenance ( sustained use ) .


The incremental effect of the IPHR on receipt of cancer screening tests and shared decision-making compared to traditional PHRs will assess Effectiveness .


In phase 2 , we will assess similar outcomes as phase 1 except for effectiveness .


This study will yield information about the effectiveness of new health information technologies designed to actively engage patients in their care as well as information about how to effectively implement and disseminate PHRs by engaging clinicians .


ClinicalTrials.gov : NCT02138448 .


Detailed characterization of asthma phenotypes is essential for identification of responder populations to allow directed personalized medical intervention .


The aim of this study was to identify distinctive patient characteristics within subgroups of a well-characterized severe asthma population at risk for exacerbations and to determine the treatment response within each subgroup .


A supervised cluster analysis with recursive partitioning approach was applied to data from the Dose Ranging Efficacy And safety with Mepolizumab ( DREAM ) study to identify characteristics that maximized the differences across subgroups .


Exacerbation rate ratios were calculated for each cluster comparing mepolizumab versus placebo .


Three predictors were identified in four primary clusters : blood eosinophils , airway reversibility , and body mass index .


The reduction in exacerbations was significantly greater in patients who received mepolizumab ( clusters 2 , 3 , and 4 ) with raised eosinophils ( responder population ) .


Cluster 2 with low airway reversibility ( mean , 11 % ) had a 53 % reduction in exacerbations .


These patients more frequently reported sinusitis and nasal polyposis .


Those with higher airway reversibility ( mean , 28 % ) were further split by body mass index .


The nonobese versus obese ( clusters 3 and 4 ) had a 35 and 67 % reduction in exacerbations , respectively .


Cluster 4 also had patients with more comorbidities , including hypertension , weight gain , and anxiety .


Using supervised cluster analysis helped identify specific patient characteristics related to disease and therapeutic response .


Patients with eosinophilic inflammation received significant therapeutic benefit with mepolizumab , and responses differed within clusters .


Clinical trial registered with www.clinicaltrials.gov ( NCT01000506 ) .


To study a trend in active sacroiliitis ( ASI ) in patients with axial spondyloarthritis ( axSpA ) during different short-term regimens using etoricoxib ( ET ) 90 mg .


Forty patients with axSpA , including 30 with ankylosing spondyloarthritis ) , and ASI ( sacroiliac joint ( SIJ ) osteitis as evidenced by magnetic resonance imaging ) were examined and then randomized to 2 groups : 1 ) 20 patients who took ET 90 mg four days or more a week ; 2 ) 20 patients who received ET 90 mg 3 days or less a week .


Osteitis was measured in 4 quadrants of each SIJ ( 0-3 scores ) .


Its main criterion was considered to be a decrease in total osteitis activity ( TOA ) 12 week later .


In all the patients ( n = 40 ) , TOA decreased from 6.5 ( 4 ; 9 ) to 2 ( 0 ; 5 ) scores ( p < 0.0001 ) .


In Group 1 ( n = 20 ) , that reduced from 6.5 ( 4 ; 8.5 ) to 0 ( 0 ; 3 ) scores ( p < 0.0001 ) .


In Group 2 ( n = 20 ) , that did from 6.5 ( 4 ; 10 ) to 4 ( 1 ; 8 ) scores ( p = 0.49 ) .


At 12 weeks , in in Groups 1 and 2 , the difference in final TOA achieved no statistical significance ( p = 0.056 ) .


In these groups , there were 19 ( 95 % ) and 14 ( 70 % ) treatment-responsive patients , respectively .


The intake of ET 90 mg for 12-weeks is associated with a reduction in the degree of ASI in patients with axSpA .


The use of ET 4 times or more a week is more effective in diminishing osteitis than that of ET 3 days or less .


To examine herpes simplex virus 2 ( HSV-2 ) / HIV co-infection as a contributing factor in the increase in HIV infection among non-injecting heroin and cocaine users in New York City .


Subjects were recruited from the Beth Israel Medical Center drug detoxification and methadone maintenance programs in New York City in 1995-1999 and 2005-2011 .


All reported current heroin and/or cocaine use and no injection drug use .


A structured questionnaire was administered and serum samples collected for HIV and HSV-2 testing .


Population-attributable risk percentages ( PAR % s ) were estimated for associations between HSV-2 and increased susceptibility to and increased transmissibility of HIV among female NIDUs .


785 subjects were recruited from 1995-1999 , and 1764 subjects from 2005-2011 .


HIV prevalence increased from 7 % to 13 % , with nearly uniform increases among all demographic subgroups .


HSV-2 / HIV co-infection was common in both time periods , with an average ( over the two time periods ) of 80 % of HIV negative females infected with HSV-2 , an average of 43 % of HIV negative males infected with HSV-2 ; an average of 97 % of HIV positive females also infected with HSV-2 and an average of 67 % of HIV positive males also infected with HSV-2 .


The increase in HIV prevalence was predominantly an increase in HSV-2 / HIV co-infection , with relatively little HIV mono-infection in either time period .


The estimated PAR % s indicate that approximately half of HIV acquisition among females was caused by HSV-2 infection and approximately 60 % of HIV transmission from females was due to HSV-2 co-infection .


The increase in HIV infection among these non-injecting drug users is better considered as an increase in HSV-2 / HIV co-infection rather than simply an increase in HIV prevalence .


Additional interventions ( such as treatment as prevention and suppressing the effects of HSV-2 on HIV transmission ) are needed to reduce further HIV transmission from HSV-2 / HIV co-infected non-injecting drug users .


Incontinence-associated dermatitis ( IAD ) is a potentially serious skin injury that can lead to pressure ulcers ( PUs ) .


Multiple studies have indicated the need for evidence to find the most effective skin care protocol to reduce the incidence and severity of IAD in critically ill patients .


To compare the incidence and severity of IAD in two groups on a progressive care unit ( PCU ) using a defined skin care protocol : cleaning with a gentle cleanser and moisturizer , then applying a skin protectant/barrier .


The control group received the skin care protocol every 12 hours and the interventional group received the protocol every 6 hours ; both groups also received it as needed .


A 9-month randomized prospective study was conducted on 99 patients ( N = 55 in the intervention group and N = 44 in the control group ) who were incontinent of urine , stool , or both , or had a fecal diversion device or urinary catheter for more than 2 days .


The dermatitis score in the intervention group on discharge was significantly less ( 7.1 % ; P 0.001 ) in the moderate IAD group than in the control group ( 10.9 % ) .


The dermatitis score means and P values of each group were compared using a paired t test .


The researchers studied a defined skin care protocol using a cleanser with aloe vera and a cleansing lotion , followed by application of either a moisture barrier with silicone or skin protectant with zinc oxide and menthol , undertaken at two different frequencies .


Data revealed the incidence of moderate IAD was decreased in the experimental group ( receiving the skin protocol every 6 hours and p.r.n. ) .


Disclosing agents have a long history of use as an aid in children 's tooth brushing instruction .


However , their benefit when used to improve self-performed tooth brushing ability without any tooth brushing instruction has not been investigated .


To evaluate the effect of disclosed plaque visualization on improving the self-performed , tooth brushing ability of primary school children .


A cluster-randomized , crossover study was conducted in Nakhon Nayok province , Thailand .


A total of 122 second-grade schoolchildren , aged 8-10 years old , from 12 schools were randomly divided into 2 groups .


The first group was assigned to brush with disclosed plaque visualization , while the other group brushed without disclosed plaque visualization .


One month later the groups switched procedures .


Tooth brushing ability was evaluated by the subjects ' reduction in patient hygiene performance ( PHP ) scores .


The data were analyzed using repeated-measures analysis of variance , with significance set at p < 0.05 .


Disclosed plaque visualization had a significant effect on improving the children 's self-performed , tooth brushing ability in all areas of the mouth ( p < 0.001 ) , particularly for anterior teeth , mandibular teeth , buccal surfaces , and areas adjacent to the gingival margin ( p < 0.001 ) .


Disclosed plaque visualization is a viable technique to improve children 's self-performed tooth brushing ability , and could be used in school-based oral health promotion programs .


The purpose of this study was to assess the effect of Roux-en-Y gastric bypass ( RYGB ) with different pouch size in Chinese type 2 diabetes mellitus ( T2DM ) patients with measured body mass index ( BMI ) 30-35 kg/m ( 2 ) .


In this randomized and prospective study , we evaluated the efficacy of RYGB with smaller size pouch ( 10-20 ml ) versus larger pouch size ( 25-35 ml ) in 76 Chinese obese patients ( 33 F , 43 M ) with T2DM .


According to protocol , all patients were divided into two groups , smaller pouch size group and larger pouch size group , and underwent RYGB surgery .


Primary inclusion criteria of study were ( a ) a diagnosis of type 2 diabetes ( glycated hemoglobin level > 7.0 % ) , ( b ) measured BMI of at least 30 kg/m ( 2 ) and not yet 35 kg/m ( 2 ) , and ( c ) age between 25 and 60 years old , and ( d ) patients were excluded if they had previously undergone complex abdominal surgery or bariatric surgery .


Weight loss , BMI , percentage of excess weight loss ( % EWL ) , glycated hemoglobin , and fasting plasma glucose were obtained at 3 , 6 , 9 , and 12 months after surgery .


Of these 76 patients , 69 ( 91 % ) patients completed follow-up postoperative 12 months .


Weight loss and % EWL at 12 months was greater in smaller pouch size group ( mean 15.8 kg , 95 % CI -17.2 to -14.4 and mean 68.9 , 95 % CI 62.5-75 .2 % ) than in larger pouch size group ( mean -13.7 kg , 95 % CI -15.3 to -12.1 , and mean 59.1 , 95 % CI 52.8-65 .5 ) ( P = 0.046 , P = 0.033 , respectively ) .


Glycemic control improved in both two groups , with a mean glycated hemoglobin level of 6.2 % ( 95 % CI 6.0-6 .5 % ) in smaller size group , and 6.7 % ( 95 % CI 6.4-7 .0 % ) in larger size group ( P = 0.025 , P < 0.05 ) .


The fasting plasma glucose level decreased significantly after surgery , with a mean level of 5.4 mmol/L ( 95 % CI 5.2-5 .5 mmol/L ) and 5.6 mmol/L ( 95 % CI 5.5-5 .8 mmol/L ) respectively , ( P = 0.040 , P < 0.05 ) .


In this short-term study , in Chinese T2DM patients with BMI 30-35 kg/m ( 2 ) , we observed a greater efficiency on weight loss and glycemic control with smaller pouch size compared to larger pouch size .


In the future , long-term follow-up and large sample study will be necessary to confirm these outcomes .


Depression commonly co-occurs with alcohol use disorders but predictors of depression treatment outcome in patients with both conditions are not well established .


Outpatients with alcohol dependence and major depression ( n = 138 ) were prescribed naltrexone and randomized to citalopram or placebo for 12 weeks , followed by a 12-week naturalistic outcome phase .


General linear mixed models examined predictors of Montgomery Asberg Depression Rating Scale ( MADRS ) score over 24 weeks .


Predictors included whether depression was independent or substance-induced , and demographic , alcohol use , and personality variables ( Temperament and Character Inventory subscales ) .


Most improvement in drinking and depression occurred between baseline and week 3 .


During follow-up , patients with substance-induced depression reduced their drinking more and they had better depression outcomes than those with independent depression .


However , greater reduction in drinking was associated with better depression outcomes for both independent and substance-induced groups , while antidepressant therapy had no effect for either group .


Baseline demographic and alcohol use variables did not predict depression outcomes .


Among personality variables , high self-directedness was a strong predictor of better depression outcomes .


Subjects were not abstinent at baseline .


The influence of naltrexone on depression outcomes could not be tested .


Alcohol dependent patients with substance-induced depression have better short term depression outcomes than those with independent depression , but this is largely because they reduce their drinking more during treatment .


To evaluate the effects of training in methods of preventing childhood obesity on self-efficacy ( SE ) in nurses .


In a randomized , controlled trial conducted in child health services in Sweden , nurses in the intervention and control groups of the PRIMROSE prevention trial of childhood obesity were offered a 5-day workshop on dietary and physical activity interventions , and motivational interviewing .


Self-efficacy for influencing parents to promote healthy dietary and physical activity behaviors in their children was measured using an 18-item instrument .


Difference in SE between groups at post-assessment was analyzed using multiple linear regression analysis .


Compared to control nurses ( n = 38 ) , intervention nurses ( n = 22 ) demonstrated higher SE ( = 14.70 , P < .001 ) .


Training in methods of preventing childhood obesity increased SE in nurses .


Self-efficacy should be included as a construct in evaluations of clinical training .


To determine the prevalence and predictors of sexual dysfunction ( SD ) in Parkinson 's disease ( PD ) patients .


Assessments of SD in the professional literature is limited .


Understanding the predictors of SD can help physicians focus on this problem in vulnerable patients .


A total of 60 PD patients and 60 controls answered the Arizona Sexual Experiences Scale-Thai Version ( ASEX-Thai ) and the Hamilton Depression Rating Scale ( HAMD ) questionnaires , and were asked on 3 additional sets of questions about premature ejaculation ( PE ) , dyspareunia , and hypersexual disorders .


The prevalence of SD in PD patients and controls was 81.6 % and 48.3 % respectively ( p < 0.05 ) .


PD patients had lower BMI , lower uric acid level , higher HAMD score and had sexual intercourse ( SI ) less frequently .


SD correlated with greater disease severity and depression .


The most distressing problem in male patients was PE ( 51.4 % ) and orgasmic dissatisfaction ( 76 % ) for female patients .


Logistic regression analysis found 3 factors were related to SD : no SI in the past month ( p < 0.001 ) , postural instability ( PI ) ( p = 0.028 ) , and HAMD item 14 ( p = 0.021 ) , predicting SD with the OR of 12.2 , 5.5 , and 5.0 respectively .


SD in PD is common and usually occurs with depression .


Absence of SI in the past month , PI , and loss of libido are predictors of SD in PD .


A simple and quick screening of SD can be routinely performed by inquiring patients about the frequency of SI and the examination of the pull test .


Detailed assessment of sexual functioning and depression may guide physicians in proper management .


The aim of this study was to evaluate the efficacy of buttressed stapling using a stapler with an attached polyglycolic acid sheet in reducing the rate of air leak associated with pulmonary lobectomy .


Materials and


A prospective , randomized , phase III study was conducted to confirm the superiority of a buttressed stapler in a test treatment group to a conventional nonbuttressed stapler in a current international standard of care group among patients undergoing pulmonary lobectomy .


The primary end point was the frequency of intraoperative air leaks .


Although no fatal postoperative bleeding occurred in the present study , this trial closed early with 100 patients because the manufacturer recalled the buttressed stapler based on reports of 13 serious injuries and 3 fatalities following pulmonary resection in routine clinical practice .


A total of 76 patients treated with a stapler ( 35 in the non-B group and 41 in the B group ) were included as subjects in the analysis .


No statistical differences were observed between the groups in the frequency of intraoperative air leaks ( 22 [ 63 % ] vs. 26 [ 63 % ] ) or the postoperative duration of air leaks ( mean : 3.5 vs. 2.9 days ) .


The frequency of air leak from stapler holes was significantly lower in the B group than in the non-B group ( 2 % [ 1/41 ] vs. 20 % [ 7/35 ] ; p = 0.016 ) .


The efficacy of buttressed stapling in reducing the rate of air leak in patients undergoing pulmonary lobectomy could not be clearly demonstrated .


However , air leak from stapler holes can be prevented with buttressed stapling .


To assess the effect of acetazolamide ( Az ) on exercise performance during early acclimatization to altitude .


Az ( 250 mg twice daily ) or placebo was administered for 3 days in a double-blind , randomized manner followed by a rapid ascent to 3459 m in the Italian Alps .


Twenty healthy adults ( age range , 18-67 years ) were tested at 60 % of sea-level peak power output for 15 minutes on a bicycle ergometer after 16 to 27 hours of altitude exposure .


Exercise performance was measured in relation to peripheral oxygen saturations measured from pulse oximetry ( Spo2 ) , Lake Louise acute mountain sickness ( AMS ) score , and perceived difficulty .


At altitude , resting Spo2 was higher in the Az group compared with placebo ( P < .001 ) .


The highest AMS scores were in 4 of the placebo individuals with the lowest resting Spo2 ( P < .05 ) .


During the exercise test , Spo2 fell in all but 1 subject ( P < .001 ) and was reduced more in the Az group ( P < .01 ) .


Four Az and 1 placebo subject were unable to complete the exercise test ; 4 of these 5 had the largest fall in Spo2 .


The perception of exercise difficulty was higher in the Az subjects compared with those taking the placebo ( P < .01 ) .


There was an age relationship with exercise limitation ; 4 of the 9 older than 50 years failed to complete the test whereas only 1 of 11 younger than 50 years failed , and there were no failures in the 6 younger than 30 years ( P < .05 ) .


In this study group , and despite higher resting Spo2 , Az may have compromised exercise at 3459 m altitude during early acclimatization , particularly in older subjects .


X-ray mammography remains the predominant test for screening for breast cancer , with the aim of reducing breast cancer mortality .


In the English NHS Breast Screening Programme each woman 's mammograms are examined separately by two expert readers .


The two readers read each batch in the same order and each indicates if there should be recall for further tests .


This is a highly skilled , pressurised , repetitive and frequently intellectually unchallenging activity where readers examine one or more batches of 30-50 women 's mammograms in each session .


A vigilance decrement or performance decrease over time has been observed in similar repetitive visual tasks such as radar operation .


The CO-OPS study is a pragmatic , multi-centre , two-arm , double blind cluster randomised controlled trial of a computer software intervention designed to reduce the effects of a vigilance decrement in breast cancer screening .


The unit of randomisation is the batch .


Intervention batches will be examined in the opposite order by the two readers ( one forwards , one backwards ) .


Control batches will be read in the same order as one another , as is current standard practice .


The hypothesis is that cancer detection rates will be higher in the intervention group because each readers ' peak performance will occur when examining different women 's mammograms .


The trial will take place in 44 English breast screening centres for 1 year and 4 months .


The primary outcome is cancer detection rate , which will be extracted from computer records after 1 year of the trial .


The secondary outcomes include rate of disagreement between readers ( a more statistically powerful surrogate for cancer detection rate ) , recall rate , positive predictive value , and interval cancer rate ( cancers found between screening rounds which will be measured three years after the end of the trial ) .


This is the first trial of an intervention to ameliorate a vigilance decrement in breast cancer screening .


ISRCTN46603370 ( submitted : 24 October 2012 , date of registration : 26 March 2013 ) .


According to the American Diabetes Association ( ADA ) , the nutritional goals for patients with type 2 diabetes ( T2D ) are to achieve an optimal nutrient intake to achieve normoglycemia and a cardioprotective lipid profile .


Peanuts are nutrient dense foods that contain high levels of monounsaturated fat ( MUFA ) and are a natural source of arginine , fiber , phytosterols , resveritrol , niacin , folate , vitamin E and magnesium , which have the potential for improving blood lipids and glycemic control .


This study sought to evaluate the effect of a peanut enriched ADA meal plan on the nutrient profile of the total diet and cardiometabolic parameters in adults with T2D .


This was a randomized , prospective 24-week parallel-group clinical trial with 60 adults with T2D [ age range 34-84years ; body mass index ( BMI ) range 17.2-48 .7 kg/m2 ] .


Subjects consumed an ADA meal plan containing ~ 20 % of energy from peanuts ( peanut group ) or a peanut-free ADA meal plan ( control group ) .


Weight , BMI , waist circumference ( WC ) and nutrient intake from 24-hour recalls were measured every 4 weeks and fasting blood glucose ( FBG ) , HbA1c and blood lipids were measured every 12 weeks .


A mixed-model repeated-measures analysis of covariance was performed to assess the significance of changes in the cardiometabolic parameters .


A higher polyunsaturated fat ( PUFA ) to saturated fat diet ratio and higher intake of MUFA , PUFA , - tocopherol , niacin and magnesium was observed in the peanut group as compared to the control group ( P < 0.01-P = 0.04 ) .


Both groups experienced mild reductions in weight , BMI , and WC during the study ( P = 0.01-P = 0.03 ) , however there were no differences between the two groups in these measurements or in FBG , HbA1c or blood lipids .


For each kilogram of weight loss in the entire cohort there were associations for reductions in WC of 0.48 cm ( P < 0.01 ) , FBG of 0.11 mmol/l ( P = 0.01 ) and HbA1c of 0.07 % ( P < 0.01 ) .


Daily consumption of a peanut enriched ( 46g/d ) ADA meal plan over 24 weeks improves the nutrient profile of the total diet and is compatible with weight management and improvement in specific blood lipids .


ClinicalTrials.gov NCT00937222 .


We tested the association between pulmonary dead-space fraction ( ratio of dead space to tidal volume [ V ( D ) / V ( T ) ] ) and mortality in subjects with ARDS ( Berlin definition , P ( aO2 ) / F ( IO2 ) 300 mm Hg ; PEEP 5 cm H2O ) enrolled into a clinical trial incorporating lung-protective ventilation .


We conducted a prospective , multi-center study at medical-surgical ICUs in the United States .


A total of 126 ALI subjects with acute lung injury were enrolled into a phase 3 randomized , placebo-controlled study of aerosolized albuterol .


V ( D ) / V ( T ) and pulmonary mechanics were measured within 4 h of enrollment and repeated daily on study days 1 and 2 in subjects requiring arterial blood gases for clinical management .


At baseline , non-survivors had a trend toward higher V ( D ) / V ( T ) compared with survivors ( 0.62 0.11 vs 0.56 0.11 , respectively , P = .08 ) .


Differences in V ( D ) / V ( T ) between non-survivors and survivors became significant on study days 1 ( 0.64 0.12 vs 0.55 0.11 , respectively , P = .01 ) and 2 ( 0.67 0.12 vs 0.56 0.11 , respectively , P = .004 ) .


Likewise , the association between VD/VT and mortality was significant on study day 1 ( odds ratio per 0.10 change in V ( D ) / V ( T ) [ 95 % CI ] : 6.84 [ 1.62-28 .84 ] P = .01 ; and study day 2 : 4.90 [ 1.28-18 .73 ] P = .02 ) after adjusting for V ( D ) / V ( T ) , P ( aO2 ) / F ( IO2 ) , oxygenation index , vasopressor use , and the primary risk for ARDS .


Using a Cox proportional hazard model , V ( D ) / V ( T ) was associated with a trend toward higher mortality ( HR = 4.37 [ CI 0.99-19 .32 ] , P = .052 ) that became significant when the analysis was adjusted for daily oxygenation index ( HR = 1.74 [ 95 % CI 1.12-3 .35 ] P = .04 ) .


Markedly elevated V ( D ) / V ( T ) ( 0.60 ) in early ARDS is associated with higher mortality .


Measuring V ( D ) / V ( T ) may be useful in identifying ARDS patients at increased risk of death who are enrolled into a therapeutic trial .


To evaluate image quality of low-voltage coronary artery computed tomographic ( CT ) angiography with low contrast agent in comparison with image quality .


Forty-five patients underwent coronary artery computed tomographic ( CT ) angiography .


They were randomly assigned to 3 groups , group A ( n = 15 ) were scanned in 120 kVp with 350 mgI/ml iodinated contrast agent mode , group B ( n = 15 ) were scanned in 100 kVp with 350 mgI/ml iodinated contrast agent mode , group C ( n = 15 ) were scanned in 100 kVp with 270 mgI/ml iodinated contrast agent mode .


Then measured CT attenuation value of three main branches ( RCA , LAD and CX ) of coronary artery , And compare the SNR , CNR , the effective radiation dose ( ED ) and iodine intake .


The Kappa test were used to quantify inter - and intra-reader agreement in detecting quality of the images under different scanning solutions .


Three groups of coronary artery CT image quality was no statistically significant differences ( all P values > 0.05 ) , Good inter - and intra-reader agreement ( k = 0.754 , P < 0.05 ) for the detection of noise in all the patients .


There was significant difference in the CT attenuation of RCA , LAD and CX among the 3 groups ( P < 0.05 ) , the CT attenuation was the highest in group B , the CT value of RCA , LAD and CX were 537 90 , 505 90 , 484 75 HU , respectively.the CT attenuation was the lowest in group C , the CT value of RCA , LAD and CX were 357 126 , 360 95 , 378 121 HU , respectively .


There was no significant difference in the SNR and CNR among the 3 groups ( P > 0.05 ) .


There was significant difference in the ED among the 3 groups ( P < 0.05 ) .


The ED value of the group A was bigger than the value of the group B and C.


There was no significant difference between the group B and C. Compared the group A and B , the iodine intake of the group C had fallen by 23 % .


The coronary artery CT angiography using 100 kVp with 270 mgI/ml iodinated contrast agent provide similar objective or subjective image quality compared with the ( 350 mgI/ml ) and the 100 kVp ( 350 mgI/ml ) , thus enabling effective dose and iodine intake reduction without loss of diagnostic information .


To determine precisely the mean change in refractive power induced by treatment in patients with diabetic macular edema ( DME ) .


Prospective , randomized study .


Fifty eyes of 50 consecutive patients with clinically significant macular edema receiving all 3 types of current state-of-the-art treatment with intravitreal antiedematous substances ( ranibizumab , bevacizumab , or triamcinolone ) .


Patients were followed up at monthly intervals and were treated following a standardized pro re nata regimen according to protocol .


Best-corrected visual acuity ( BCVA ) was determined by certified visual acuity examiners .


The refractive power of the treated eyes was determined using a push-plus technique .


The change in refraction between baseline and the visit when the macula was completely dry or when the central subfield thickness ( CST ) measured by optical coherence tomography had reached the thinnest level was analyzed .


Spherical equivalent refraction ( SER ) and CST .


Fifty eyes of 50 patients received intravitreal therapy using ranibizumab ( n = 11 ) , bevacizumab ( n = 20 ) , or triamcinolone ( n = 19 ) .


Mean BCVA was 0.330.23 logarithm of the minimum angle of resolution ( logMAR ) and mean CST was 492130 m.


The mean SER was 0.412.06 diopters ( D ) at baseline .


The BCVA at the time of optimal retinal morphologic features was 0.240.2 logMAR , mean CST was 30078 m , and mean change in SER was -0.010.46 D. Changes is BCVA and CST were statistically significant ( P < 0.0001 ) , but the SER change was not ( P = 0.824 ) .


Appropriate spectacle correction can be prescribed to patients with DME any time during ongoing therapy using antiedematous substances because resolution of retinal thickening is not associated with an increased risk of a myopic shift .


High-frequency oscillation combined with tracheal gas insufflation ( HFO-TGI ) improves oxygenation in patients with acute respiratory distress syndrome ( ARDS ) .


There are limited physiologic data regarding the effects of HFO-TGI on hemodynamics and pulmonary edema during ARDS .


The aim of this study was to investigate the effect of HFO-TGI on extravascular lung water ( EVLW ) .


We conducted a prospective , randomized , crossover study .


Consecutive eligible patients with ARDS received sessions of conventional mechanical ventilation with recruitment maneuvers ( RMs ) , followed by HFO-TGI with RMs , or vice versa .


Each ventilatory technique was administered for 8 hours .


The order of administration was randomly assigned .


Arterial/central venous blood gas analysis and measurement of hemodynamic parameters and EVLW were performed at baseline and after each 8-hour period using the single-indicator thermodilution technique .


Twelve patients received 32 sessions .


Pao2/fraction of inspired oxygen and respiratory system compliance were higher ( P < .001 for both ) , whereas extravascular lung water index to predicted body weight and oxygenation index were lower ( P = .021 and .029 , respectively ) in HFO-TGI compared with conventional mechanical ventilation .


There was a significant correlation between Pao2/fraction of inspired oxygen improvement and extravascular lung water index drop during HFO-TGI ( Rs = -0.452 , P = .009 ) .


High-frequency oscillation combined with tracheal gas insufflation improves gas exchange and lung mechanics in ARDS and potentially attenuates EVLW accumulation .


To examine the association between blood pressure ( BP ) measures and symptoms of apathy and depression in older adults with various levels of functional ability .


Cross-sectional study using baseline data from the Discontinuation of Antihypertensive Treatment in Elderly people ( DANTE ) Study Leiden .


Primary care setting , the Netherlands .


Community-dwelling individuals aged 75 and older ( N = 430 ) .


Systolic BP ( SBP ) , diastolic BP ( DBP ) , and mean arterial pressure ( MAP ) were measured during home visits .


Symptoms of apathy and depression were assessed using the Apathy Scale and the Geriatric Depression Scale ( GDS-15 ) , respectively .


Stratified linear regression was performed in participants with better and worse functional ability according to the median of the Groningen Activity Restriction Scale .


In participants with lower functional ability , each 10-mmHg lower SBP , DBP , and MAP was associated with higher Apathy Scale scores ( 0.63 , 0.92 , and 0.94 points , respectively , all P < .005 ) but not with GDS-15 scores .


In participants with higher functional ability , BP measures were not associated with Apathy Scale or GDS-15 scores .


In older participants with poorer functional ability , lower BP was associated with more symptoms of apathy but not depression .


To examine the association between second-trimester maternal serum 25-hydroxyvitamin D concentrations and risk of small for gestational age ( SGA ) in singleton live births .


We assayed serum samples at 12-26 weeks of gestation for 25-hydroxyvitamin D in a sample of participants in a multicenter clinical trial of low-dose aspirin for the prevention of preeclampsia in high-risk women ( n = 792 ) .


Multivariable log-binomial regression models were used to assess the association between 25-hydroxyvitamin D and risk of SGA ( birth weight less than the 10 percentile for gestational age ) after adjustment for confounders including maternal prepregnancy obesity , race , treatment allocation , and risk group .


Thirteen percent of neonates were SGA at birth .


Mean ( standard deviation ) 25-hydroxyvitamin D concentrations were lower in women who delivered SGA ( 57.9 [ 29.9 ] nmol/L ) compared with non-SGA neonates ( 64.8 [ 29.3 ] nmol/L , P = .028 ) .


In adjusted models , 25-hydroxyvitamin D concentrations of 50-74 nmol/L and 75 nmol/L or greater compared with less than 30 nmol/L were associated with 43 % ( 95 % confidence interval [ CI ] 0.33-0 .99 ) and 54 % ( 95 % CI 0.24-0 .87 ) reductions in risk of SGA , respectively .


Race and maternal obesity each modified this association .


White women with 25-hydroxyvitamin D 50 nmol/L or greater compared with less than 50 nmol/L had a 68 % reduction in SGA risk ( adjusted risk ratio 0.32 , 95 % CI 0.17-0 .63 ) and nonobese women with 25-hydroxyvitamin D 50 nmol/L or greater compared with less than 50 nmol/L had a 50 % reduction in SGA risk ( adjusted risk ratio 0.50 , 95 % CI 0.31-0 .82 ) .


There was no association between 25-hydroxyvitamin D and risk of SGA in black or obese mothers .


Maternal vitamin D status in the second trimester is associated with risk of SGA among all women and in the subgroups of white and nonobese women .


II .


Bright constant light levels in the NICU may have negative effects on the growth and development of preterm infants


The aim of this study is to evaluate the benefits of an alternating light/dark cycle in the NICU on weight gain and early discharge from the therapy in premature infants .


A randomized interventional study was designed comparing infants in the NICU of Hospital Juarez de Mxico , exposed from birth either to an LD environment ( LD , n = 19 ) or to the traditional continuous light ( LL , n = 19 ) .


The LD condition was achieved by placing individual removable helmets over the infant 's heads .


Body weight gain was analyzed , as the main indicator of stability and the main criteria for discharge in preterm infants born at 31.730.31 week gestational age .


Infants maintained in an LD cycle gained weight faster than infants in LL and therefore attained a shorter hospital stay , ( 34.373.12 vs 51.115.29 days ; P > 0.01 ) .


Also , LD infants exhibited improved oxygen saturation and developed a daily melatonin rhythm .


These findings provide a convenient alternative for establishing an LD environment for preterm healthy newborns in the NICU and confirm the beneficial effects of an alternating LD cycle for growth and weight gain and for earlier discharge time .


Here we provide an easy and practical alternative to implement light/dark conditions in the NICU .


Over-the-counter combinations containing acetaminophen and phenylephrine for treatment of the common cold and influenza are widespread , but there are few data about pharmacokinetics of these two drugs used in combination .


We aimed to investigate pharmacokinetic interactions between acetaminophen and phenylephrine .


A series of four randomised , open-label , crossover studies investigating phenylephrine and acetaminophen combination pharmacokinetics were undertaken ( n = 28 , 30 , 6 and 26 ) using standard non-compartmental analyses .


Time-concentration observations from these four studies were pooled to examine the interaction between these two compounds .


Data were analysed using non-linear mixed effects models .


Non-compartmental analyses showed an approximate doubling of phenylephrine plasma concentration when the standard 10-mg dose was administered in combination with acetaminophen .


Population analysis was based on data from 90 subjects with 2050 observations .


The relative bioavailability of phenylephrine 10 mg was doubled ( Fbio 2.11 , 95 % CI 1.89 , 2.31 ) when combined with acetaminophen 1000 mg , while the absorption half-time was reduced by 50 % .


When combined with 500 mg of acetaminophen , bioavailability increased by 64 % ( Fbio 1.64 ) .


Phenylephrine 5 mg in combination with acetaminophen 1000 mg produced a phenylephrine plasma time-concentration profile similar to that seen with phenylephrine 10 mg administered alone .


The relative bioavailability of phenylephrine was increased when co-administered with acetaminophen .


The Schirmer test ( ST ) evaluates the volume of tears in potential dry eye candidates via a strip placed in the lower tear lake .


Previously reported inconsistencies in the results may be in part due to the lack of standardization as to the methodology , e.g. the eye position during the test .


The purpose of this study was to evaluate the effect of eye position on the ST score .


A ST was performed in a randomized fashion with and without anesthesia in three open eye positions ( primary , superior and inferior ) at 20 from each other .


Palpebral aperture , age and a dry eye questionnaire ( OSDI ) were evaluated for correlation with the ST.


In the 20 non-dry eye volunteers ( n = 20 , ages 18-40 , mean OSDI score 10.5 ) , the ST results were , as expected , lower overall ( p < .001 ) with anesthesia ( 11.33 7.78 mm ) than without ( 19.74 2.83 mm ) .


The inferior gaze position resulted in higher values ( p < .03 ) than the other two positions , regardless of the use of anesthesia .


No correlation was noted between the palpebral aperture , age , questionnaire and the ST.


The ST seems to be influenced by the position of gaze .


However , the mechanism for this , effect remains unclear .


Further studies could focus on whether an inferior gaze of 20 compresses the tear film falsely , thereby elevating the tear volume .


It is recommended that the clinician should adopt a standard eye position for the ST and that future reports provide specifics as to the methodology used .


To prospectively evaluate whether short-term high-intensity ( interval ) training ( HI ( I ) T ) induces detectable morphological cardiac changes in previously untrained men in cardiovascular magnetic resonance imaging .


Eighty-four untrained volunteers were randomly assigned to a HI ( I ) T group ( n = 42 ; 44.14.7 years ) or an inactive control group ( n = 42 ; 42.35.6 years ) .


HI ( I ) T focused on interval runs ( intensity : 95 % -105 % of individually calculated heart rate at the anaerobic threshold ) .


Before and after 16 weeks , all subjects underwent physiological examination , stepwise treadmill test with blood lactate analysis , and contrast-enhanced cardiovascular magnetic resonance imaging ( cine , tagging , and delayed enhancement ) .


Indexed left ventricular ( LV ) and right ventricular ( RV ) volume ( LV , 77.18.5-83 .98.6 ; RV , 80.58.5-86 .68.1 ) and mass ( LV , 58.26.4-63 .48.1 ; RV , 14.81.7-16 .12.1 ) significantly increased with HI ( I ) T. Changes in LV and RV morphological parameters with HI ( I ) T were highly correlated with an increase in maximal aerobic capacity ( VO2max ) and a decrease in blood lactate concentration at the anaerobic threshold .


Mean LV and RV remodeling index of HI ( I ) T group did not alter with training ( 0.76 0.09 and 0.240.10 g/mL , respectively [ P = 0.97 and P = 0.72 ] ) , indicating balanced cardiac adaptation .


Myocardial circumferential strain decreased after HI ( I ) T within all 6 basal segments ( anteroseptal , P = 0.01 and anterolateral , P < 0.001 ) .


There was no late gadolinium enhancement in any of the participants before or post HI ( I ) T.


Sixteen weeks of HI ( I ) T lead to measurable changes in cardiac atrial and ventricular morphology and function in previously untrained men .


This correlates with improvements in parameters of endurance capacity .


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


Unique identifier : NCT01406730 .


Shoulder surgery is often performed in the beach-chair position , a position associated with arterial hypotension and subsequent risk of cerebral ischaemia .


It can be performed under general anaesthesia or with an interscalene brachial plexus block , each of which has specific advantages but also specific negative effects on blood pressure control .


It would be worthwhile to combine the advantages of the two , but the effects of the combination on the circulation are not well investigated .


We studied blood pressure , heart rate , and incidence of adverse circulatory events in patients undergoing shoulder surgery in general anaesthesia with or without an interscalene block .


Prospective , randomised , blinded study in outpatients ( age 18 to 80years ) undergoing shoulder arthroscopy .


General anaesthesia was with propofol/opioid , interscalene block with 40ml 1 % mepivacaine .


Hypotension requiring treatment was defined as a mean arterial pressure < 60mmHg or a systolic pressure < 80 % of baseline ; relevant bradycardia was a heart rate < 50bpm with a decrease in blood pressure .


Forty-two patients had general anaesthesia alone , 41 had general anaesthesia plus interscalene block .


The average systolic blood pressure under anaesthesia in the beach-chair position was 1147.3 vs. 1168.3 mmHg ( p = 0.09 ; all comparisons General vs. General-Regional ) .


The incidence of a mean arterial pressure under 60mmHg or a decrease in systolic pressure of more than 20 % from baseline was 64 % vs. 76 % ( p = 0.45 ) .


The number of patients with a heart rate lower than 50 and a concomitant blood pressure decrease was 8 vs. 5 ( p = 0.30 ) .


One can safely combine interscalene block with general anaesthesia for surgery in the beach-chair position in ASA I and II patients .


DRKS00005295 .


No clinically effective treatment for promoting peripheral axonal regeneration has yet been established .


Several experimental studies in vitro and in vivo have shown that a high dose of methylcobalamin ( MeCbl ) , an analogue of vitamin B12 , promotes axonal growth in peripheral nerve injury .


We herein assessed the safety and efficacy of an ultra-high dose MeCbl treatment for patients with peripheral neuropathy and chronic axonal degeneration .


Fourteen patients with immune-mediated or hereditary neuropathy in the chronic progressive or stable phase were enrolled .


MeCbl , 25 mg/day for 10 days followed by monthly 25 mg for 5 months , was intravenously administered .


The patients were evaluated before and 1 year following treatment .


The primary endpoints were safety and improvement in the Medical Research Council ( MRC ) sum score in at least two muscles of the 20 muscles .


This trial is registered with the University Hospital Medical Information Network ( UMIN ) Center in Japan under the ID : UMIN000009359 .


There were no adverse effects in twelve of the patients , whereas treatment was discontinued in two patients who had seborrheic dermatitis at 3 months and respiratory tract infection at 2 months , respectively .


Therefore , twelve patients were evaluated for the primary outcomes ; the MRC sum score was improved in seven of the patients and unchanged or worsened in the remaining five patients .


Intravenous ultra-high dose MeCbl treatment is a safe and potentially efficacious therapy for patients with peripheral neuropathy and chronic axonal degeneration .


To validate robot-assisted surgery skills acquisition using an augmented reality ( AR ) - based module for urethrovesical anastomosis ( UVA ) .


Participants at three institutions were randomised to a Hands-on Surgical Training ( HoST ) technology group or a control group .


The HoST group was given procedure-based training for UVA within the haptic-enabled AR-based HoST environment .


The control group did not receive any training .


After completing the task , the control group was offered to cross over to the HoST group ( cross-over group ) .


A questionnaire administered after HoST determined the feasibility and acceptability of the technology .


Performance of UVA using an inanimate model on the daVinci Surgical System ( Intuitive Surgical Inc. , Sunnyvale , CA , USA ) was assessed using a UVA evaluation score and a Global Evaluative Assessment of Robotic Skills ( GEARS ) score .


Participants completed the National Aeronautics and Space Administration Task Load Index ( NASA TLX ) questionnaire for cognitive assessment , as outcome measures .


A Wilcoxon rank-sum test was used to compare outcomes among the groups ( HoST group vs control group and control group vs cross-over group ) .


A total of 52 individuals participated in the study .


UVA evaluation scores showed significant differences in needle driving ( 3.0 vs 2.3 ; P = 0.042 ) , needle positioning ( 3.0 vs 2.4 ; P = 0.033 ) and suture placement ( 3.4 vs 2.6 ; P = 0.014 ) in the HoST vs the control group .


The HoST group obtained significantly higher scores ( 14.4 vs 11.9 ; P 0.012 ) on the GEARS .


The NASA TLX indicated lower temporal demand and effort in the HoST group ( 5.9 vs 9.3 ; P = 0.001 and 5.8 vs 11.9 ; P = 0.035 , respectively ) .


In all , 70 % of participants found that HoST was similar to the real surgical procedure , and 75 % believed that HoST could improve confidence for carrying out the real intervention .


Training in UVA in an AR environment improves technical skill acquisition with minimal cognitive demand .


The purpose of this study was to test the efficacy of clomipramine and fluoxetine , controlled by placebo , and compare their action in children and adolescents with anxiety disorders .


Thirty subjects ( ages 7-17 years ) , who were diagnosed with generalized anxiety disorder and/or separation anxiety disorder and/or social phobia , were submitted to a 12 week double-blind , randomized , placebo-controlled trial of clomipramine and fluoxetine .


The instruments included : the Schedule for Affective Disorders and Schizophrenia , the Multidimensional Anxiety Scale for Children , the Children 's Depression Inventory , the Clinical Global Impressions , and the Children 's Global Assessment Scale .


All groups ( clomipramine [ n = 9 ] , fluoxetine [ n = 10 ] , placebo [ n = 11 ] ) showed a significant improvement after 12 weeks of treatment .


There were significant differences between the fluoxetine and placebo groups in some ratings of anxiety severity and impairment .


No significant differences were observed between clomipramine and placebo groups or between fluoxetine and clomipramine groups .


Treatment with placebo showed an unusual high response rate .


Clomipramine showed similar efficacy compared with fluoxetine , although it was not superior to placebo .


Opioid antagonism reduces the consumption of palatable foods in humans but the neural substrates implicated in these effects are less well understood .


The aim of the present study was to examine the effects of the opioid antagonist , naltrexone , on neural response to rewarding and aversive sight and taste stimuli .


We used functional magnetic resonance imaging ( fMRI ) to examine the neural responses to the sight and taste of pleasant ( chocolate ) and aversive ( mouldy strawberry ) stimuli in 20 healthy volunteers who received a single oral dose of naltrexone ( 50mg ) and placebo in a double-blind , repeated-measures cross-over , design .


Relative to placebo , naltrexone decreased reward activation to chocolate in the dorsal anterior cingulate cortex and caudate , and increased aversive-related activation to unpleasant strawberry in the amygdala and anterior insula .


These findings suggest that modulation of key brain areas involved in reward processing , cognitive control and habit formation such as the dorsal anterior cingulate cortex ( dACC ) and caudate might underlie reduction in food intake with opioid antagonism .


Furthermore we show for the first time that naltrexone can increase activations related to aversive food stimuli .


These results support further investigation of opioid treatments in obesity .


Disturbance of the sleep-wake cycle is a characteristic of delirium .


In addition , changes in melatonin rhythm influence the circadian rhythm and are associated with delirium .


We compared the effect of melatonin and placebo on the incidence and duration of delirium .


We performed this multicentre , double-blind , randomized controlled trial between November 2008 and May 2012 in 1 academic and 2 nonacademic hospitals .


Patients aged 65 years or older who were scheduled for acute hip surgery were eligible for inclusion .


Patients received melatonin 3 mg or placebo in the evening for 5 consecutive days , starting within 24 hours after admission .


The primary outcome was incidence of delirium within 8 days of admission .


We also monitored the duration of delirium .


A total of 452 patients were randomly assigned to the 2 study groups .


We subsequently excluded 74 patients for whom the primary end point could not be measured or who had delirium before the second day of the study .


After these postrandomization exclusions , data for 378 patients were included in the main analysis .


The overall mean age was 84 years , 238 ( 63.0 % ) of the patients lived at home before admission , and 210 ( 55.6 % ) had cognitive impairment .


We observed no effect of melatonin on the incidence of delirium : 55/186 ( 29.6 % ) in the melatonin group v. 49/192 ( 25.5 % ) in the placebo group ; difference 4.1 ( 95 % confidence interval -0.05 to 13.1 ) percentage points .


There were no between-group differences in mortality or in cognitive or functional outcomes at 3-month follow-up .


In this older population with hip fracture , treatment with melatonin did not reduce the incidence of delirium .


Netherlands Trial Registry , NTR1576 : MAPLE ( Melatonin Against PLacebo in Elderly patients ) study ; www.trialregister.nl/trialreg/admin/rctview.asp?TC=1576 .


Left ventricular hypertrophy is associated with adverse outcomes , including death , during cardiac surgery .


This may be facilitated by an increased oxygen demand and diastolic dysfunction .


Levosimendan augments haemodynamics without further oxygen consumption and improves echocardiographic indices of diastolic dysfunction .


This study aimed to describe the haemodynamic effects of short-term pre - and intra-operative levosimendan infusion including advanced echocardiographic measures of diastolic and systolic heart function .


The study was randomised , double-blinded and placebo-controlled performed at a single-centre university hospital .


Patients with left ventricular hypertrophy and ejection fraction > 45 % scheduled for single procedure aortic valve replacement were included and randomised to infusion of either levosimendan 0.1 g/kg/min or placebo from 4 h before anaesthesia to the end of surgery .


Outcome measures were echocardiographic indices of left ventricular diastolic function : E/e ' ( primary endpoint ) , e ' , e ' / a ' and indices of systolic function : longitudinal strain , ejection fraction and s ' .


Patients were followed until 6 months after surgery .


In addition , invasive haemodynamic measures were obtained perioperatively .


The trial was prematurely terminated due to an overall high incidence of post-operative atrial fibrillation ( 15/20 , P = 0.002 ) after inclusion of 20 patients .


The relative decrease in perioperative cardiac index was lower ( P = 0.016 ) in the levosimendan group .


There was no difference in E/e ' , and similar results were found for all measures of systolic function .


Short-term levosimendan caused a transient relative increase in cardiac index , but no effect was seen on the first post-operative day and up to 6 months post-operatively with indices of systolic and diastolic heart function .


Chemotherapy-induced nausea and vomiting ( CINV ) is an unanswered problem in cancer therapy .


We evaluated the efficacy and safety of triple antiemetic therapy with aprepitant , a 5-hydroxytryptamine-3 ( 5-HT ( 3 ) ) receptor antagonist , and dexamethasone in patients with advanced non-small-cell lung cancer ( NSCLC ) who received carboplatin-based first-line chemotherapy .


Chemotherapy-nave patients with NSCLC were enrolled in this randomized phase-II study .


Patients were randomized to standard antiemetic therapy with a 5-HT ( 3 ) receptor antagonist and dexamethasone , and aprepitant add-on triple antiemetic therapy .


The primary endpoint was the complete response rate ( no vomiting and no rescue therapy ) during the 120 h post-chemotherapy .


A total of 134 patients were assigned randomly to the aprepitant group or the control group .


The aprepitant group and the control group showed an overall complete response rate of 80.3 % ( 95 % confidence interval ( CI ) , 69.2-88 .1 % ) and 67.2 % ( 95 % CI , 55.3-77 .2 % ; odds ratio ( OR ) , 0.50 ; 95 % CI , 0.22-1 .10 ; p = 0.085 ) , respectively .


Among patients taking carboplatin and pemetrexed , adding aprepitant significantly improved the complete response rate in the overall phase ( 83.8 % in the aprepitant group and 56.8 % in the control group ; OR , 0.26 ; 95 % CI , 0.08-0 .70 ; p < 0.01 ) and the delayed phase ( 86.5 % in the aprepitant group and 59.1 % in the control group ; OR , 0.23 ; 95 % CI , 0.07-0 .65 ; p < 0.01 ) .


Carboplatin-based chemotherapy has considerable emetic potential .


Triple antiemetic therapy with aprepitant , a 5-HT ( 3 ) receptor antagonist , and dexamethasone improved the control of CINV prevention in patients receiving carboplatin and pemetrexed chemotherapy .


Shebeens in South Africa are settings in which alcohol use and sexual behavior often co-occur .


The prevalence of alcohol use disorder ( AUD ) , and the association between AUD , situations and settings , and sexual risk behavior , in shebeens remains unknown .


Men ( n = 763 ; mean age = 30 ; 98 % Black African ) were recruited from townships in Cape Town , South Africa and completed a self-administered survey that assessed alcohol use , sexual risk behaviors , and situations and settings of alcohol use .


The Alcohol Use Disorder and Associated Disabilities Interview Schedule DSV-IV Version ( AUDADIS-IV ) was used to identify the likelihood of AUD .


Bivariate regression analyses assessed whether screening for AUD predicted sexual risk behaviors .


Multivariate regression analyses examined whether AUD and/or situations/settings predicted risk behaviors .


Nearly two-thirds of men ( 62 % ) endorsed sufficient criteria for AUD ; 25 % , 17 % , and 20 % were classified as having a mild , moderate , or severe AUD , respectively .


AUD was associated with HIV risk such that men with AUD reported more unprotected sex than men without AUD .


Analyses indicated that ( a ) individual ( i.e. , AUD ) and ( b ) settings ( i.e. , frequency of having sex with a partner in a shebeen , tavern , or bottle store ) interacted to predict unprotected sex .


The prevalence of AUD among shebeen patrons was high and was associated with unprotected sex .


Findings suggest the need to integrate both individual and situational/setting factors to prevent HIV among patrons of shebeens .


Several endoscopic dilation techniques have been reported for treatment of anastomotic-stenosis of esophageal cancer , but the high incidence of dysphagia has remained unchanged .


The aim of this study was to compare the effect of Argon Plasma Coagulation ( APC ) combined with Savary Bougienage ( SB ) compared to APC alone or SB alone for anastomotic-stenosis after radical operation for squamous cell carcinoma of the esophagus .


Patients with anastomotic-stenosis that was diagnosed for the first time following esophageal squamous cell carcinoma resection surgery were randomly assigned to undergo APC combined with SB , APC alone , or SB alone .


Primary endpoints were the dysphagia-free survival ( DFS defined as the time from first dilatation of effectively relieved dysphagia to dysphagia relapse expressed in days ) after 6 months of follow up .


A total of 90 patients from the Cancer Institute , First Affiliated Hospital of Henan University of Science and Technology were entered into the study ( APC group , n = 30 , SB group , n = 30 , combination group [ APC combined with SB ] , n = 30 ) .


Primary endpoints : 6 months after treatment , DFS of combination group ( 115.63 days ; 95 % CI , 105.31-125 .95 ) was significantly longer than the APC alone group ( 39.53 days ; 95 % CI , 35.95-43 .11 , p = 0.000 ) and the SB alone group ( 16.93 days ; 95 % CI , 15.01-18 .84 , p = 0.000 ) .


No severe complications occurred within the three treatment groups .


APC combined with SB was a safe and well-tolerated method for relieving dysphagia of esophageal squamous cell cancer patients with anastomotic-stenosis .


( Registered with randomized controlled trials , ChiCRT , registration number ChiCTR-TRC-13003757 . )


An unmet medical need exists for patients with metastatic renal cell carcinoma who have progressed on VEGF-targeted and mTOR-inhibitor therapies .


Fibroblast growth factor ( FGF ) pathway activation has been proposed as a mechanism of escape from VEGF-targeted therapies .


Dovitinib is an oral tyrosine-kinase inhibitor that inhibits VEGF and FGF receptors .


We therefore compared dovitinib with sorafenib as third-line targeted therapies in patients with metastatic renal cell carcinoma .


In this multicentre phase 3 study , patients with clear cell metastatic renal cell carcinoma who received one previous VEGF-targeted therapy and one previous mTOR inhibitor were randomly assigned through an interactive voice and web response system to receive open-label dovitinib ( 500 mg orally according to a 5-days-on and 2-days-off schedule ) or sorafenib ( 400 mg orally twice daily ) in a 1:1 ratio .


Randomisation was stratified by risk group and region .


The primary endpoint was progression-free survival ( PFS ) assessed by masked central review .


Efficacy was assessed in all patients who were randomly assigned and safety was assessed in patients who received at least one dose of study drug .


This study is registered with ClinicalTrials.gov , number NCT01223027 .


284 patients were randomly assigned to the dovitinib group and 286 to the sorafenib group .


Median follow-up was 113 months ( IQR 79-146 ) .


Median PFS was 37 months ( 95 % CI 35-39 ) in the dovitinib group and 36 months ( 35-37 ) in the sorafenib group ( hazard ratio 086 , 95 % CI 072-104 ; one-sided p = 0063 ) .


280 patients in the dovitinib group and 284 in the sorafenib group received at least one dose of study drug .


Common grade 3 or 4 adverse events included hypertriglyceridaemia ( 38 [ 14 % ] ) , fatigue ( 28 [ 10 % ] ) , hypertension ( 22 [ 8 % ] ) , and diarrhoea ( 20 [ 7 % ] ) in the dovitinib group , and hypertension ( 47 [ 17 % ] ) , fatigue ( 24 [ 8 % ] ) , dyspnoea ( 21 [ 7 % ] ) , and palmar-plantar erythrodysaesthesia ( 18 [ 6 % ] ) in the sorafenib group .


The most common serious adverse event was dyspnoea ( 16 [ 6 % ] and 15 [ 5 % ] in the dovitinib and sorafenib groups , respectively ) .


Dovitinib showed activity , but this was no better than that of sorafenib in patients with renal cell carcinoma who had progressed on previous VEGF-targeted therapies and mTOR inhibitors .


This trial provides reference outcome data for future studies of targeted inhibitors in the third-line setting .


Novartis Pharmaceuticals Corporation .


Recruitment is one of the most serious challenges in performing randomized controlled trials .


Often clinical trials with participants diagnosed with schizophrenia are terminated prematurely because of recruitment challenges resulting in a considerable waste of resources in the form of time , funding , and the participants ' efforts .


Dropout rates in schizophrenia trials are also high.Recruitment challenges are often due to patients not wanting to participate in research but can also be due to clinicians ' concerns regarding individuals diagnosed with schizophrenia as participants in research .


This paper reports how overcoming recruitment challenges not related to patients revealed high readiness to take part and low dropout rates in a one year long randomized controlled trial testing Guided Self-Determination ( GSD ) among outpatients with schizophrenia receiving treatment in Assertive Outreach Teams in the northern part of Denmark .


GSD is a shared decision-making and mutual problem-solving method using reflection sheets , which was developed in diabetes care and adjusted for this study and utilized by patients with schizophrenia .


Descriptive data on strategies to overcome recruitment challenges were derived from notes and observations made during the randomized controlled trial testing of GSD in six outpatient teams .


Three types of recruitment challenges not related to patients were identified and met during the trial : 1 ) organizational challenges , 2 ) challenges with finding eligible participants and 3 ) challenges with having professionals invite patients to participate .


These challenges were overcome through : 1 ) extension of time , 2 ) expansion of the clinical recruitment area and 3 ) encouragement of professionals to invite patients to the study .


Through overcoming these challenges , we identified a remarkably high patient-readiness to take part ( 101 of 120 asked accepted ) and a low dropout rate ( 8 % ) .


Distinction between recruitment challenges was important in discovering the readiness among patients with schizophrenia to take part in and complete a trial with the GSD-intervention .


The main aim was to assess the effects of a spa treatment on the resumption of occupational and non-occupational activities and the abilities of women in breast cancer remission .


A cost-effectiveness analysis ( CEA ) was also performed .


A multicentre randomised controlled trial was carried out between 2008 and 2010 in the University Hospital of Auvergne and two private hospitals in Clermont-Ferrand , France .


Eligible patients were women in complete breast cancer remission without contraindication for physical activities or cognitive disorders and a body mass index between 18.5 and 40 kg/m ( 2 ) .


The intervention group underwent spa treatment combined with consultation with dietician whereas the control underwent consultations with the dietician only .


Of the 181 patients randomised , 92 and 89 were included in the intervention and the control groups , respectively .


The CEA involved 90 patients , 42 from the intervention group and 48 from the control group .


The main results showed a higher rate of resumption of occupational activities in the intervention group ( p = 0.0025 ) and a positive effect of the intervention on the women 's ability to perform occupational activities 12 months after the beginning of the study ( p = 0.0014 ) , and on their ability to perform family activities ( p = 0.033 ) .


The stay in a thermal centre was cost-effective at 12 months .


Spa treatment is a cost-effective strategy to improve resumption of occupational and non-occupational activities and the abilities of women in breast cancer remission .


Medical treatment settings such as emergency departments ( EDs ) present important opportunities to address problematic substance use .


Currently , EDs do not typically intervene beyond acute medical stabilization .


To contrast the effects of a brief intervention with telephone boosters ( BI-B ) with those of screening , assessment , and referral to treatment ( SAR ) and minimal screening only ( MSO ) among drug-using ED patients .


Between October 2010 and February 2012 , 1285 adult ED patients from 6 US academic hospitals , who scored 3 or greater on the 10-item Drug Abuse Screening Test ( indicating moderate to severe problems related to drug use ) and who were currently using drugs , were randomized to MSO ( n = 431 ) , SAR ( n = 427 ) , or BI-B ( n = 427 ) .


Follow-up assessments were conducted at 3 , 6 , and 12 months by blinded interviewers .


Following screening , MSO participants received only an informational pamphlet .


The SAR participants received assessment plus referral to addiction treatment if indicated , and the BI-B participants received assessment and referral as in SAR , plus a manual-guided counseling session based on motivational interviewing principles and up to 2 `` booster '' sessions by telephone during the month following the ED visit .


Outcomes evaluated at follow-up visits included self-reported days using the patient-defined primary problem drug , days using any drug , days of heavy drinking , and drug use based on analysis of hair samples .


The primary outcome was self-reported days of use of the patient-defined primary problem drug during the 30-day period preceding the 3-month follow-up .


Follow-up rates were 89 % , 86 % , and 81 % at 3 , 6 , and 12 months , respectively .


For the primary outcome , estimated differences in number of days of use ( 95 % CI ) were as follows : MSO vs BI-B , 0.72 ( -0.80 to 2.24 ) , P ( adjusted ) = .57 ; SAR vs BI-B , 0.70 ( -0.83 to 2.23 ) , P ( adjusted ) = .57 ; SAR vs MSO , -0.02 ( -1.53 to 1.50 ) , P ( adjusted ) = .98 .


There were no significant differences between groups in self-reported days using the primary drug , days using any drug , or heavy drinking days at 3 , 6 , or 12 months .


At the 3-month follow-up , participants in the SAR group had a higher rate of hair samples positive for their primary drug of abuse ( 265 of 280 [ 95 % ] ) than did participants in the MSO group ( 253 of 287 [ 88 % ] ) or the BI-B group ( 244 of 275 [ 89 % ] ) .


Hair analysis differences between groups at other time points were not significant .


In this sample of drug users seeking emergency medical treatment , a relatively robust brief intervention did not improve substance use outcomes .


More work is needed to determine how drug use disorders may be addressed effectively in the ED .


clinicaltrials.gov Identifier : NCT01207791 .


The `` m '' in mHealth is often thought of as the ability to receive health information and monitor behaviors on the go .


Little is known about how people actually use mobile vs. traditional access methods and if access method affects engagement and health outcomes .


This study examines the 3-month outcomes of two mobile weight loss interventions ( Pounds Off Digitally ( POD ) and mobile POD ( mPOD ) ) where participants were required to own a mobile device for study entry and received weight loss information via podcast .


Only participants in both studies who were randomized to receive the same theory-based podcast ( TBP ) were used in this analysis .


In POD , 41 participants were randomized to the TBP condition ( 37 to a control not included in this analyses ) .


In mPOD , 49 participants were randomized to the TBP ( n = 49 ) and 47 to the TBP + mobile group ( a self-monitoring app and Twitter app for social support ) .


The goal of this study is to examine how participants accessed study components and to examine how type of device impacts engagement and weight loss .


Examining data from both studies in aggregate , despite a mobile delivery method , 58 % of participants reported using a non-mobile device to access the majority of the podcasts ( desktop computers ) , 76 % accessed the podcasts mostly at their home or work , and 62 % were mainly non-mobile ( e.g. , sitting at work ) when listening .


Examining objective download data for mPOD , 49 % of downloads ( 2889/5944 ) originated from non-mobile delivery methods vs. mobile platforms ( 3055/5944 ) .


At 3 months , 55 % of Twitter posts originated from the website ( n = 665 posts ) vs. a mobile app ( n = 540 ; 45 % ) .


There was no difference in the number of podcasts participants reported listening to by device .


There were more Twitter posts by mobile app users ( 5111 ) than Twitter website users ( 236 , p < 0.05 ) .


There was a trend ( p = 0.055 ) in greater weight loss among mobile users for podcasts ( -3.50.5 % ) as compared to non-mobile users ( -2.50.5 % ) .


Weight loss was significantly greater in Twitter mobile app users ( -5.60.9 % ) than website users ( -2.20.5 % , p < 0.01 ) .


Type of device used for podcast listening did not affect engagement but there was a trend toward greater weight loss among mobile users .


Method of Twitter posting was associated with engagement and weight loss with mobile app users posting more to Twitter and losing more weight .


To compare outcome after total hip arthroplasty ( THA ) through the mini-incision approach versus the standard transgluteal approach .


80 women and 63 men aged 33 to 89 ( mean , 62 ) years with primary osteoarthritis of the hip were randomised to undergo unilateral THA through a mini-incision approach ( Micro-hip , n = 55 ) or standard , lateral , transgluteal approach ( Bauer , n = 88 ) .


Levels of haemoglobin , haematocrit , serum creatine kinase , and C-reactive protein , length of hospital stay , mobilisation , and any complication were recorded .


Visual analogue scale ( VAS ) for pain was assessed .


Hip function was assessed using the Harris Hip Score and the Oxford Hip Score , whereas general health was assessed using the EQ-5D general health questionnaire .


The cup inclination and varus/valgus of the stem position were measured using a goniometer .


The Micro-hip group achieved a significantly lower mean incision length ( 9.3 vs. 13.4 cm , p < 0.001 ) , mean surgical time ( 60 vs. 68 minutes , p = 0.021 ) , mean reduction in haemoglobin level ( 2.1 vs. 2.8 g/dl , p < 0.001 ) , and mean VAS for pain from hour 6 to day 6 ( all p < 0.05 ) .


One patient in the Micro-hip group developed early aseptic loosening of the cup and underwent revision surgery at month 4 .


Three patients in the Bauer group and one patient in the Micro-hip group sustained intra-operative nondisplaced fractures of the proximal femur , which were fixed with cerclages .


Two patients in the Microhip group developed deep vein thrombosis during week 1 .


THA through the Micro-hip approach achieved faster pain relief .


Chronic low back pain ( LBP ) and neck pain ( NP ) are highly prevalent conditions resulting in high economic costs .


Treatment guidelines recommend relaxation techniques , such as progressive muscle relaxation , as adjuvant therapies .


Self-care interventions could have the potential to reduce costs in the health care system , but their effectiveness , especially in a usual care setting , is unclear .


The aim of these two pragmatic randomized studies is to evaluate whether an additional app-delivered relaxation is more effective in the reduction of chronic LBP or NP than usual care alone .


Each pragmatic randomized two-armed study aims to include a total of 220 patients aged 18 to 65 years with chronic ( > 12 weeks ) LBP or NP and an average pain intensity of4 on a numeric rating scale ( NRS ) in the 7 days before recruitment .


The participants will be randomized into an intervention and a usual care group .


The intervention group will be instructed to practice one of these 3 relaxation techniques on at least 5 days/week for 15 minutes/day over a period of 6 months starting on the day of randomization : autogenic training , mindfulness meditation , or guided imagery .


Instructions and exercises will be provided using a smartphone app , baseline information will be collected using paper and pencil .


Follow-up information ( daily , weekly , and after 3 and 6 months ) will be collected using electronic diaries and questionnaires included in the app .


The primary outcome measure will be the mean LBP or NP intensity during the first 3 months of intervention based on daily pain intensity measurements on a NRS ( 0 = no pain , 10 = worst possible pain ) .


The secondary outcome parameters will include the mean pain intensity during the first 6 months after randomization based on daily measurements , the mean pain intensity measured weekly as the average pain intensity of the previous 7 days over 3 and 6 months , pain acceptance , ` LBP - and NP-related ' stress , sick leave days , pain medication intake , adherence , suspected adverse reaction , and serious adverse events .


The designed studies reflect a usual self-care setting and will provide evidence on a pragmatic self-care intervention that is easy to combine with care provided by medical professionals .


ClinicalTrials.gov identifier Relaxback NCT02019498 , Relaxneck NCT02019134 registered on 18 December 2013 .


Migraine is a painful neurological disorder that affects over 10 % of the general population .


Frovatriptan and rizatriptan are antimigraine agents belonging to the triptan class .


Although previous studies have independently compared the efficacy of these agents , contemporaneous data examining both pharmacokinetic ( PK ) properties and efficacy in parallel have not previously been available .


In this single-center double-blind study , 18 subjects ( ten female ) were treated for a single migraine attack with frovatriptan 2.5 mg or rizatriptan 10 mg .


Plasma concentrations were measured predose and at 2 , 4 , 6 , 12 , 24 , 48 , and 72 hours after drug administration .


The primary end point of this study was to evaluate the association between PK parameters and efficacy measures and recurrence rate .


Secondary end points were pain-free and pain-relief episodes at 2 and 4 hours , recurrent episodes within 48 hours , and cumulative hazard of recurrence within 72 hours .


At baseline , approximately 17 % of patients had mild migraine , while 83 % had moderate-severe migraine .


Although the time to maximum concentration was similar for both drugs ( 2.7 versus 2.3 hours ) , the terminal half-life for frovatriptan was longer than rizatriptan ( 29.3 versus 3.2 hours , P < 0.0001 ) .


The proportion of patients who were pain-free at 4 hours without rescue medication was higher in the frovatriptan-treated group , ( 38.9 versus 5.6 % , P = 0.045 ) .


The cumulative hazard of recurrence over 72 h was reduced by frovatriptan compared to rizatriptan-treated patients ( log-rank test , P = 0.04 ) .


Pain-free and pain-relief episodes for the study period were positively correlated with the concentration : maximum concentration ( Cmax ) ratio for frovatriptan ( r = 0.52 , P = 0.028 ) , but not rizatriptan .


Recurrence rate was negatively correlated with the concentration : Cmax ratio for both frovatriptan ( r = -0.96 , P = 0.0024 ) and rizatriptan ( r = -0.98 , P = 0.0004 ) .


Fewer adverse events were observed for frovatriptan compared to rizatriptan ( one versus eight , P = 0.021 ) .


This pilot study indicates that a similar extent of initial pain relief is afforded by both triptans in migraine treatment .


The longer duration of action of frovatriptan parallels and correlates with its PK profile .


The 2010 guidelines recommend new requirements of the chest compression depth for infant .