Patients aged 18 or older consulting with an acute LRTI in whom pneumonia was not suspected by the clinician .


Amoxicillin ( two 500mg tablets three times a day for 7days ) or matched placebo .


Clinician-rated symptom severity between days 2-4 ; new/worsening symptoms and presence of side effects at 4-weeks .


Adherence was captured using self-report and tablet counts .


2061 participants were randomised to the amoxicillin or placebo group .


On average , 88 % of the prescribed amoxicillin was taken .


The original analysis demonstrated small increases in both benefits and harms from amoxicillin .


Minor improvements in the benefits of amoxicillin were observed when an adjustments for adherence were made ( mean difference in symptom severity -0.08 , 95 % CI -0.17 to 0.01 , OR for new/worsening symptoms 0.81 , 95 % CI 0.66 to 0.98 ) as well as minor increases in harms ( OR for side effects 1.32 , 95 % CI 1.12 to 1.57 ) .


Adherence to amoxicillin was high , and the findings from the original analysis were robust to non-adherence .


Participants consulting to primary care with an acute uncomplicated LRTI can on average expect minor improvements in outcome from taking amoxicillin .


However , they are also at an increased risk of experiencing side effects .


Eudract-CT 2007-001586-15 and ISRCTN52261229 .


The trial was registered at EudraCT in 2007 due to an administrative misunderstanding that EudraCT was a suitable registry -- which it was not in 2007 , but has become since .


On discovery of this error , the trial was also registered at ISRCTN ( January 2009 ) .


Trial procedures did not change between the two registrations .


To determine whether an online support tool can impact anxiety in women experiencing an abnormal mammogram .


We developed an online support system using the Comprehensive Health Enhancement Support System ( CHESS ) designed for women experiencing an abnormal mammogram as a model .


Our trial randomized 130 of these women to online support ( the intervention group ) or to a list of five commonly used Internet sites ( the comparison group ) .


Surveys assessed anxiety and breast cancer worry , and patient satisfaction at three important clinical time points : when women were notified of their abnormal mammogram , at the time of diagnostic imaging , and at the time of biopsy ( if biopsy was recommended ) .


Study participants in the intervention group showed a significant decrease in anxiety at the time of biopsy compared to the comparison group ( p = 0.017 ) .


However , there was no significant difference in anxiety between the intervention group and the comparison group at the time of diagnostic work-up .


We discontinued assessment of patient satisfaction after finding that many women had substantial difficulty answering the questions that referenced their physician , because they did not understand who their physician was for this process of care .


The combination of the inability to identify the physician providing care during the mammography work-up and anxiety effects seen only after an interaction with the breast imaging team may indicate that online support only decreases the anxiety of women in concert with direct interpersonal support from the healthcare team .


Patients with advanced cancer have reduced quality of life , which tends to worsen towards the end of life .


We assessed the effect of early palliative care in patients with advanced cancer on several aspects of quality of life .


The study took place at the Princess Margaret Cancer Centre ( Toronto , ON , Canada ) , between Dec 1 , 2006 , and Feb 28 , 2011.24 medical oncology clinics were cluster randomised ( in a 1:1 ratio , using a computer-generated sequence , stratified by clinic size and tumour site [ four lung , eight gastrointestinal , four genitourinary , six breast , two gynaecological ] ) , to consultation and follow-up ( at least monthly ) by a palliative care team or to standard cancer care .


Complete masking of interventions was not possible ; however , patients provided written informed consent to participate in their own study group , without being informed of the existence of another group .


Eligible patients had advanced cancer , European Cooperative Oncology Group performance status of 0-2 , and a clinical prognosis of 6-24 months .


Quality of life ( Functional Assessment of Chronic Illness Therapy -- Spiritual Well-Being [ FACIT-Sp ] scale and Quality of Life at the End of Life [ QUAL-E ] scale ) , symptom severity ( Edmonton Symptom Assessment System [ ESAS ] ) , satisfaction with care ( FAMCARE-P16 ) , and problems with medical interactions ( Cancer Rehabilitation Evaluation System Medical Interaction Subscale [ CARES-MIS ] ) were measured at baseline and monthly for 4 months .


The primary outcome was change score for FACIT-Sp at 3 months .


Secondary endpoints included change score for FACIT-Sp at 4 months and change scores for other scales at 3 and 4 months .


This trial is registered with ClinicalTrials.gov , number NCT01248624 .


461 patients completed baseline measures ( 228 intervention , 233 control ) ; 393 completed at least one follow-up assessment .


At 3-months , there was a non-significant difference in change score for FACIT-Sp between intervention and control groups ( 356 points [ 95 % CI -027 to 740 ] , p = 007 ) , a significant difference in QUAL-E ( 225 [ 001 to 449 ] , p = 005 ) and FAMCARE-P16 ( 379 [ 174 to 585 ] , p = 00003 ) , and no difference in ESAS ( -170 [ -526 to 187 ] , p = 033 ) or CARES-MIS ( -066 [ -225 to 094 ] , p = 040 ) .


At 4 months , there were significant differences in change scores for all outcomes except CARES-MIS .


All differences favoured the intervention group .


Although the difference in quality of life was non-significant at the primary endpoint , this trial shows promising findings that support early palliative care for patients with advanced cancer .


Canadian Cancer Society , Ontario Ministry of Health and Long Term Care .


To evaluate the 6-month clinical effects of one scaling and root planing ( SRP ) procedure alone or combined with local administration of hydrogen peroxide gel ( with or without inclusion of doxycycline for 2 weeks ) using periodontal medicament carriers in the form of customized prescription trays for treatment of subjects with chronic periodontitis .


Using a randomized controlled design , 61 subjects with moderate to advanced periodontitis were assigned to three parallel treatment groups : 1 ) SRP combined with prescription-tray ( Perio Tray ) application of 1.7 % hydrogen peroxide gel ( Perio Gel ) and , for the first 2 weeks , doxycycline , 2 ) SRP combined with prescription-tray application of peroxide gel , and 3 ) SRP alone .


All subjects brushed twice daily with standard dentifrice and toothbrush for a 4-week acclimation phase , and continued this regimen throughout the 6-month treatment phase .


Pocket probing depth ( PPD ) and bleeding index ( BI ) were assessed on natural and restored sites at baseline and after 2 , 5 , 13 , and 26 weeks .


SRP was performed 3 weeks after baseline .


Clinical variables were compared by ANCOVA and paired t-tests after each treatment interval , analyzing natural and restored sites separately .


57 subjects completed the trial .


Analysis of pockets > 5 mm at baseline showed that mean PPD for both test groups significantly decreased from baseline approximately 0.50 mm prior to SRP .


Two weeks following SRP , mean PPD significantly decreased from baseline by > 0.90 mm for both test groups and 0.29 mm for the control .


By 26 weeks , mean PPD decreased > 1.10 mm for both test groups compared to 0.38 mm for the SRP-only control ( P < 0.001 for test versus control at all post-SRP comparisons ) .


Analysis of pockets 5 mm at baseline showed the same relationship between groups ( P < 0.001 for test versus control ) .


Mean BI dropped significantly only for test groups before SRP , and the tray/peroxide-doxycycline group was significantly different from the control ( P = 0.033 ) .


Two weeks post-SRP , mean BI reductions for test groups were significantly greater than the control , and remained so for most comparisons .


For restored sites , mean PPDs of both test groups were significantly better ( P < 0.05 ) than the control for all post-baseline comparisons .


To identify the effectiveness of rational-emotive-behavior-based therapy ( REBT-based therapy ) on improved mental health and antiretroviral ( ART ) therapeutic adherence in women infected with HIV/AIDS ( female subjects with HIV/AIDS ) .


A randomized and single-blinded clinical trial in women infected with HIV/AIDS who had their treatment at the outpatient clinic of Pokdiksus AIDS RSCM and at the AIDS Comprehensive Diagnostic Unit of Dharmais Hospital was conducted between October 2011 and March 2012 .


A block randomization of 160 female subjects with AIDS was performed that resulted in a REBT-based treatment group ( n = 80 ) and a control group ( n = 80 ) .


The treatment group received REBT-based intervention of 8 sessions weekly including 6 individual-therapeutic sessions/week and 2 group-therapeutic sessions/week .


Instruments used in the study were questionnaires on demography , ART adherence ( measured by self report and pill count ) , and mental health ( SRQ-20 ) .


Data were analyzed using Chi-Square test , Generalized Linear Model , and Generalized Estimating Equations .


There were 148 respondents analyzed including in the REBT-based group ( n = 72 ) and in the control group ( n = 76 ) with mean age of 33-34 years .


After 8 weeks of REBT-based intervention , there was improved ( increased ) mean value of the self-reported adherence score ( self-report ) compared to control group ( 100 % ; CI 95 % ,83.3 -96.7 vs. 84 % ; CI 95 % ,77.5 -87.8 ) and improved ( decreased ) SRQ-20 mean score in REBT-based treatment group compared to control group ( 2.9 ; CI 95 % , 2.7-13 .0 vs. 5.4 ; CI 95 % : 5.0-13 .6 ) .


ART adherence based on viral load titer was not analyzed in both group since most of VL titer were undetected ( < 400 copies/mL ) .


GLM analysis showed decreased SRQ-20 mean score and increased mean value of self-reported ART adherence ( self-report ) in the REBT-based treatment group , which were more significant ( p < 0.000 ) than control group on the 8th week .


GEE analysis showed that 1 point decrement of SRQ-20 would increase self-reported ART adherence as much as 0.722 point and the correlation was statistically significant ( p < 0.00 ) .


After 8 weeks of REBT-based intervention to female subjects with HIV/AIDS , there is a decrease of SRQ-20 mean score which may result in increased ART adherence mean score in the treatment group compared to the control .


To compare the effects of ultrasonography with laparoscopy on transcervical resection of septa ( TCRS ) .


The study included 126 patients with uterine septum at the present hospital between January 2010 and August 2012 that were randomly divided into two groups .


Seventy patients had TCRS monitored by ultrasound ( ultrasound group ) while 56 patients were monitored by laparoscope ( laparoscope group ) .


Both groups were followed up for six to 24 months .


The intraoperative status , short-term and long-term complications after operation , and pregnancy outcome of two groups were compared .


The operations of both groups were successfully completed .


The operating time , the first time to get out of bed , postoperative 24hNRS ( numeric rating scale ) values , postoperative hospital stay , and the incidence of postoperative septum residue of ultrasound group were significantly less than laparoscope group ( p < 0.05 ) .


No statistical differences were observed in intraoperative complications and pregnancy ratio between the two groups .


Both ultrasound and laparoscope monitored TCRS were safe and effective in the treatment of uterine septum .


Ultrasound monitored TCRS was more simple , economical , accurate , and non-invasive .


For patients without abnormal lesions in pelvic cavity , the present authors tend to choose the ultrasound monitored TCRS .


To investigate the cost-effectiveness of a rapid response team ( RRT ) , compared with usual care ( UC ) , for treating suicidal adolescents .


Suicidal adolescents ( n = 286 ) presenting at an emergency department were enrolled in a trial to compare UC with enhanced outpatient care provided by an RRT of health professionals .


Functioning ( Child Global Assessment Scale ) and suicidality ( Spectrum of Suicidal Behavior Scale ) scores were measured at baseline and 6 months later .


Resource use and cost data were collected from several sources during the same period .


As previously reported , there was no statistically or clinically significant difference in either functioning or suicidality between the groups .


Costs of the RRT were lower by $ 1886 , thus - $ 1886 ( 95 % CI - $ 4238 to $ 466 ) , from the perspective of the treating hospital , and by $ 991 , thus - $ 991 ( 95 % CI - $ 5580 to $ 3598 ) , from the perspective of society .


If decision makers are not willing to pay for any improvement in functioning or suicidality , the RRT has a 95 % probability of being cost-effective from the perspective of the treating hospital .


From the point of view of society , the probability of the intervention being cost-effective is about 70 % for functioning and 63 % for suicidality .


The difference between the 2 perspectives is mainly attributable to the cost of hospitalizations outside the treating hospital .


An RRT intervention appears to be cost-effective , compared with UC , from the point of view of the treating hospital , but there is no difference from the point of view of society .


The cardio-renal syndrome plays a critical role in acute heart failure ( HF ) .


Levosimendan , an inodilator drug , has a positive but controversial effect on kidney .


Our aim was to evaluate its effects on both renal and systemic haemodynamic parameters as well as on renal function , explaining the possible mechanisms involved .


Patients with acute decompensated HF , moderate renal impairment , wedge pressure > 20mmHg and EF < 40 % were eligible .


Twenty-one patients were randomized to infusion of levosimendan or placebo , on top of standard therapy .


Systemic haemodynamic parameters ( wedge and cardiac output ) were evaluated at baseline and at 8 , 16 , 24 , 48 , and 72h .


An intravascular renal artery Doppler exam was performed at baseline , after levosimendan bolus , and 1h thereafter .


Renal blood flow , glomerular filtration rate ( GFR ) , cystatin C , blood urea nitrogen ( BUN ) , urinary output , sodium excretion , and plasma sodium were measured .


The effect of levosimendan was beneficial and significantly different from placebo on several renal and cardiac parameters .


Specifically , the levosimendan and placebo group exhibited significantly different changes over time in GFR ( P = 0.037 ) , renal blood flow ( P = 0.037 ) , and renal artery diameter ( P = 0.033 ) , with ensuing improvements in serum levels of BUN ( P = 0.014 ) , creatinine ( P = 0.042 ) , and cystatin C ( P = 0.05 ) .


Concomitantly , levosimendan provided a significant increase in urine output up to 72h ( P = 0.02 ) .


These beneficial results on renal parameters were accompanied by similarly significant and favourable changes in cardiac index ( P = 0.029 ) and PCWP ( P < 0.001 ) .


Levosimendan , in acute decompensated HF , has an immediate renoprotective effect , mediated by an increase in renal blood flow , due to a selective renal arterial and venous vasodilating action .


NCT00527059 .


To compare the efficacy between elongated needle therapy and regular needle therapy at Tiantu ( CV 22 ) on the basis of xingnao kaiqiao ( activiting brain and regaining consciousness ) acupuncture therapy so as to explore the effective therapeutic method in treatment of dysphagia induced by bulbar palsy .


Seventy one cases of dysphagia induced by bulbar palsy were randomized into two groups .


The xingnao kaiqiao acupuncture therapy was applied at Shuigou ( GV 26 ) , Neiguan ( PC 6 ) , Sanyinjiao ( SP 6 ) and the others in the two groups .


In the elongated needle therapy group , on the basis of xingnao kaiqiao acupuncture therapy , the elongated needle was used to puncture Tiantu ( CV 22 ) .


In the regular needle therapy , the regular acupuncture technique was used at Tiantu ( CV 22 ) .


In both groups , the treatment was given once a day in a week except Sunday and lasted for 4 weeks totally .


Before and after treatment , the swallowing condition and the standardized swallowing assessment ( SSA ) were observed in the patients and the efficacy was compared between the two groups .


The total effective rate was 97.2 % ( 35/36 ) in the elongated needle therapy group , which was better than 77.1 % ( 27/35 ) in the regular needle therapy group ( P < 0.05 ) .


After treatment , SSA score was reduced significantly as compared with that before treatment in the two groups ( both P < 0.05 ) .


SSA score in the elongated needle therapy group was reduced much more apparently as compared with that in the regular needle therapy group after treatment ( P < 0.05 ) .


On the basis of the xingnao kaiqiao acupuncture therapy , the elongated needle therapy at Tiantu ( CV 22 ) achieves the superior effect on bulbar palsy-induced dysphagia as compared with the regular acu - puncture at Tiantu ( CV 22 ) .


Botulinum toxin Type A ( BoNT A ) for the treatment of facial wrinkles is delivered through local injection .


We previously demonstrated that topical surface application of BoNT A has negligible cutaneous bioavailability and is not effective in treating wrinkles .


To determine the effect of BoNT A solution applied topically on the skin surface immediately after ablative fractional CO2 laser treatment .


We conducted a randomized controlled trial for patients with periorbital wrinkles ( crow 's feet ) ( n = 10 ) .


Treatment was performed on both sides of the face with fractional ablative CO2 laser followed by the application of topical solutions of BoNT A on one side and normal saline as control on the other side .


Pretreatment assessment was performed , and at 1 and 4 weeks after treatment .


There was a clinically significant greater degree of improvement in wrinkles after treatment with CO2 laser , on the topically applied BoNT A side .


Also , the difference between the 2 treatment types ( laser followed by topical BoNT A vs laser followed by saline ) at 1 week and at 1 month was statistically significant .


Topically , noninjectable form of BoNT A applied on the surface of the skin after ablative fractional CO2 laser is effective in the treatment of lateral periorbital wrinkles .


To evaluate the incidence of surgical site infection ( SSI ) based on the type of scalpel used for incisions in the skin and in subcutaneous tissues .


Observer-blind , randomized equivalence clinical trial with two arms ( electrocautery versus conventional scalpel ) which evaluated 133 women undergoing elective abdominal gynecologic oncology surgery .


A simple randomization stratified by body mass index ( BMI : 30 kg/m ( 2 ) ) was carried out .


Women were evaluated at 14 and 30 days following the operation .


A multivariate analysis was performed in order to check whether the type of scalpel would be a risk factor for SSI .


Group arms were balanced for all variables , excepted for surgical time , which was significantly higher in the electrocautery group ( mean : 161.1 versus 203.5 min , P = 0.029 ) .


The rates of SSI were 7.4 % and 9.7 % , respectively , for the conventional scalpel and electrocautery groups ( P = 0.756 ) .


The exploratory multivariate model identified body mass index 30 kg/m ( 2 ) ( OR = 24.2 , 95 % CI : 2.8-212 .1 ) and transverse surgical incision ( OR = 8.1 , 95 % CI : 1.5-42 .6 ) as independent risk factors for SSI .


The type of scalpel used in surgery , when adjusted for these variables and the surgery time , was not a risk factor for SSI .


This study showed that the SSI rates for conventional scalpel and electrocautery were not significantly different .


These results were consistent with others reported in the literature and would not allow a surgeon to justify scalpel choice based on SSI .


NCT01410175 ( Clinical Trials - NIH ) .


Photophobia and phonophobia are the most prominent symptoms in patients with migraine without aura .


Hypersensitivity to visual stimuli can lead to greater hypersensitivity to auditory stimuli , which suggests that the interaction between visual and auditory stimuli may play an important role in the pathogenesis of migraine .


However , audiovisual temporal interactions in migraine have not been well studied .


Therefore , our aim was to examine auditory and visual interactions in migraine .


In this study , visual , auditory , and audiovisual stimuli with different temporal intervals between the visual and auditory stimuli were randomly presented to the left or right hemispace .


During this time , the participants were asked to respond promptly to target stimuli .


We used cumulative distribution functions to analyze the response times as a measure of audiovisual integration .


Our results showed that audiovisual integration was significantly elevated in the migraineurs compared with the normal controls ( p < 0.05 ) ; however , audiovisual suppression was weaker in the migraineurs compared with the normal controls ( p < 0.05 ) .


Our findings further objectively support the notion that migraineurs without aura are hypersensitive to external visual and auditory stimuli .


Our study offers a new quantitative and objective method to evaluate hypersensitivity to audio-visual stimuli in patients with migraine .


To evaluate whether chloroquine ( CQ ) is more effective than meloxicam for treating early musculoskeletal pain and arthritis following acute chikungunya ( CHIK ) virus infection .


During the 2006 CHIK epidemic , 509 rural community cases of acute CHIK virus infection were identified in the district of Sholapur in India .


Seventy consenting adult patients ( seropositive for IgM/IgG anti-CHIK antibody ) with early persistent musculoskeletal pain and arthritis were randomized into a 24-week , 2-arm , parallel efficacy trial of CQ ( 250 mg/day ) and meloxicam ( 7.5 mg/day ) .


Assessors completed a rheumatology evaluation in a blinded manner and collected blood samples in the patients ' homes , as per protocol .


Laboratory parameters included serum cytokine assay ( interleukin-6 [ IL-6 ] , interferon - [ IFN ] , tumor necrosis factor , CXCL10/IFN-inducible protein 10 , and IL-13 ) .


Twenty-two patients who failed to meet the eligibility criteria ( low pain cohort ) were also followed up with similar evaluations .


An intent-to-treat analysis was completed .


At baseline , the 2 groups ( 38 patients randomized to receive CQ and 32 patients randomized to receive meloxicam ) were well matched .


There were no significant efficacy differences between the meloxicam group and the CQ group ( mean changes in the visual analog scale score for pain -3.9 and -4.2 , respectively ) .


Patients improved significantly .


Cytokine levels remained several-fold increased , were disproportionate to the clinical response , and were not different from those in the low pain cohort .


Seven patients withdrew .


Adverse events were mild and infrequent .


This exploratory community intervention trial failed to identify an advantage of CQ over meloxicam to treat early musculoskeletal pain and arthritis following acute CHIK virus infection , but therapeutic efficacy of CQ was not ruled out .


The inflammatory cytokine response was intense and was not consistent with clinical status .


This study investigated the impact of early enteral nutrition ( EEN ) on the clinical outcomes of gastric cancer patients after radical gastrectomy .


Four hundred gastric cancer patients undergoing radical gastrectomy of any extend with D2 nodal dissection were randomly divided into an experimental and a control group with 200 cases in each group .


Patients in the control group received postoperative parenteral nutrition ( PN ) , while patients in the experimental group received postoperative EEN .


After treatment , the clinical outcomes , postoperative immune function , and nutritional status of the two groups were evaluated .


The postoperative fever time , intestinal function recovery time , anal exhaust time , and the length of hospital stay for patients in the experimental group were significantly shorter than those of the control group .


We did not find significant differences in anastomotic leak , postoperative ileus and regurgitation between the two groups .


The activities of multiple immune cell types , including CD3 , CD4 , CD4/CD8 , and natural killer ( NK ) cells , were significantly lower in both groups on postoperative day 1 when compared with the preoperative levels ( p < 0.05 ) .


The level of CD8 was not significantly different between the two groups ( p > 0.05 ) .


After treatment , levels of CD3 , CD4 , CD4/CD8 , and NK cells in the experimental group patients were 35.6 4.2 , 42.2 3.0 , 1.7 0.3 , and 27.3 5.3 % , respectively , on postoperative day 7 , which were similar to the preoperative levels .


The immune cell levels from the control group patients remained significantly lower when compared with preoperative values ; in addition , these values were also significantly lower when compared with the EEN patients ( p < 0.05 ) CONCLUSION : For gastric cancer patients undergoing radical gastrectomy , the clinical outcome , immune function and nutritional status after EEN were significantly improved .


These data suggest the widespread use of EEN in clinical practice .


Severe mentally ill ( SMI ) patients have a reduced life expectancy of 13-30 years compared to the general population , largely due to an increased risk of cardiovascular mortality .


Unhealthy lifestyle behaviours in SMI patients contribute to this increased risk .


The obesogenic living environment of patients in residential facilities may even pose an extra risk .


Although several studies have shown positive effects of lifestyle interventions on SMI patients ' weight status , studies including residential patients and their obesogenic environment are scarce .


This paper describes the Effectiveness of Lifestyle Interventions in PSychiatry trial ( ELIPS ) .


The goal of this trial is to improve cardiometabolic health in severe mentally ill residential patients by addressing the obesogenic environment .


The ELIPS study is a multi-site cluster randomised controlled trial ( RCT ) based on the principles of a pragmatic RCT .


All residential and long-term clinical care teams of two large mental health care organisations in the North of the Netherlands serving SMI patients are invited to participate .


The intervention is aimed at team level .


Lifestyle coaches first develop a team specific lifestyle plan that tailors the ELIPS goals and protocol and then train teams on how to create a healthy environment and stimulate healthy behaviours in patients .


After three months , teams take over the intervention after they have set out goals to achieve in the following nine months .


In this phase , adherence to the lifestyle plan and pre-set goals is monitored .


Patients in the control arm receive care as usual .


Primary outcome measure is waist circumference at three and 12months after baseline .


ELIPS is different from previously published lifestyle intervention studies in three ways .


First , it follows the principles of a pragmatic design , which enables the examination of effects in everyday practice .


Second , by implementing the intervention at team level , we expect lifestyle activities to be maintained when interventionists leave .


Last , by targeting the obesogenic environment we create a prerequisite for any sustainable health improvement , as patients can only make healthy choices in a healthy living environment .


Nederlands Trialregister NTR2720 ( Dutch Trial Register , www.trialregister.nl ) .


Registered 27 January 2011 .


Crotalidae Polyvalent Immune Fab ( Ovine ) has been the only antivenom commercially available in the US since 2007 for treatment of Crotalinae envenomation .


Late coagulopathy can occur or recur after clearance of Fab antivenom , often after hospital discharge , lasting in some cases more than 2 weeks .


There have been serious , even fatal , bleeding complications associated with recurrence phenomena .


Frequent follow-up is required , and additional intervention or hospitalization is often necessary .


F ( ab ' ) 2 immunoglobulin derivatives have longer plasma half life than do Fab .


We hypothesized that F ( ab ' ) 2 antivenom would be superior to Fab in the prevention of late coagulopathy following treatment of patients with Crotalinae envenomation .


We conducted a prospective , double-blind , randomized clinical trial , comparing late coagulopathy in snakebitten patients treated with F ( ab ' ) 2 with maintenance doses [ F ( ab ' ) 2/F ( ab ' ) 2 ] , or F ( ab ' ) 2 with placebo maintenance doses [ F ( ab ' ) 2/placebo ] , versus Fab with maintenance doses [ Fab/Fab ] .


The primary efficacy endpoint was coagulopathy ( platelet count < 150 K/mm ( 3 ) , fibrinogen level < 150 mg/dL ) between end of maintenance dosing and day 8 .


121 patients were randomized at 18 clinical sites and received at least one dose of study drug .


114 completed the study .


Of these , 11/37 ( 29.7 % ) in the Fab/Fab cohort experienced late coagulopathy versus 4/39 ( 10.3 % , p < 0.05 ) in the F ( ab ' ) 2/F ( ab ' ) 2 cohort and 2/38 ( 5.3 % , p < 0.05 ) in the F ( ab ' ) 2/placebo cohort .


The lowest heterologous protein exposure was with F ( ab ' ) 2/placebo .


No serious adverse events were related to study drug .


In each study arm , one patient experienced an acute serum reaction and one experienced serum sickness .


In this study , management of coagulopathic Crotalinae envenomation with longer-half-life F ( ab ' ) 2 antivenom , with or without maintenance dosing , reduced the risk of subacute coagulopathy and bleeding following treatment of envenomation .


Efficacy of the conventional - versus high-dose vancomycin regimen in patients with acute bacterial meningitis was compared .


In a randomized clinical trial 44 patients with acute bacterial meningitis were randomly assigned to the conventional - or high-dose vancomycin groups .


Clinical and laboratory parameters were used for evaluation of response to the treatment regimens .


In the high-dose group , leukocytosis and fever resolved significantly faster than those in the conventional group .


Furthermore , the length of hospitalization was shorter and Glasgow Coma Scale at the end of 10th day was significantly lower in the high dose compared to the conventional group .


Trend of creatinine clearance changes did not differ significantly between the two groups .


In comparison to the conventional-dose regimen , the high-dose vancomycin regimen was associated with significantly more favorable clinical response without increase in the incidence of nephrotoxicity in patients with acute bacterial meningitis .


Cushing 's disease ( CD ) can significantly impair patients ' health-related quality of life ( HRQOL ) .


This study investigated the treatment effectiveness of pasireotide on HRQOL of CD patients , and assessed the relationships between HRQOL and urinary free cortisol ( UFC ) and CD-related signs and symptoms .


In this phase III , randomized , double-blind study , patients with UFC 1.5 upper limit of normal ( ULN ) received s.c. pasireotide 600 or 900g twice daily .


The trial primary endpoint was UFC at or below ULN at month 6 without dose titration .


Open-label treatment continued through month 12 .


HRQOL was measured using the Cushing 's Quality of Life Questionnaire ( CushingQoL ) instrument at baseline and follow-up visits until month 12 during which clinical signs and features of CD , and the Beck Depression Inventory II ( BDI-II ) , were also collected .


Pearson 's / Spearman 's correlations between changes in CushingQoL and changes in clinical signs and symptoms were assessed .


Changes in CushingQoL and the proportion of patients achieving a clinically meaningful improvement in CushingQoL were also compared among patients stratified by mean UFC ( mUFC ) control status ( controlled , partially controlled , and uncontrolled ) at month 6 .


Analyses were also conducted at month 12 , with multivariable adjustment for baseline characteristics and CushingQoL .


Change in CushingQoL was significantly correlated with changes in mUFC ( r = -0.40 ) , BMI ( r = -0.39 ) , weight ( r = -0.41 ) , and BDI-II ( r = -0.54 ) at month 12 but not at month 6 .


The percentage of CushingQoL responders at month 12 based on month 6 mUFC control status were as follows : 63 , 58.8 , and 37.9 % in the controlled , partially controlled , and uncontrolled groups respectively .


Adjusted CushingQoL scores at month 12 were 58.3 for controlled patients ( = 11.5 vs uncontrolled , P = 0.012 ) and 54.5 for partially controlled patients ( = 7.7 vs uncontrolled , P = 0.170 ) .


Pasireotide treatment can result in a meaningful HRQOL improvement among those who complete a 12-month treatment period , most often among patients achieving biochemical control .


Prenatal maternal stress is associated with adverse birth outcomes .


Relaxation techniques might be effective in reducing stress during that period .


The purpose of this study was to evaluate the effects of applied relaxation in reducing anxiety and stress in pregnant women in their second trimester , as well as raising their sense of control .


Also we expected to see a difference in some lifestyle factors associated with stress .


A randomized control trial with a prospective pretest-posttest experimental design was used .


Sixty primigravida women in their second trimester were assigned randomly to receive a 6-week stress management programme ( N = 31 ) ( relaxation breathing and progressive muscle relaxation , RB-PMR , twice a day ) or not ( N = 29 ) .


Self-reported validated measures were used to evaluate perceived stress , health locus of control and anxiety at baseline and at the end of the 6-weeks follow-up .


The results of the study demonstrated significant benefits from the use of the techniques in the psychological state of the pregnant women .


The systematic implementation of the proposed relaxation techniques contributed in the reduction of perceived stress ( mean change -3.23 , 95 % CI : -4.29 to -0.29 ) and increased the sense of control ( mean change 1.99 , 95 % CI : 0.02-3 .7 ) .


The findings suggest beneficial effects of relaxation on reducing perceived stress as well as increment of sense of control in pregnant women .


The results of this study support the claim that training in the proposed relaxation techniques may constitute an ideal , non-pharmaceutical , intervention that can promote well-being , at least during pregnancy .


Longer studies will be necessary in the future , in order to examine the long-term effects of relaxation techniques .


This study examined mediators and moderators of short-term treatment effectiveness from the iQUITT Study ( Quit Using Internet and Telephone Treatment ) , a 3-arm randomized trial that compared an interactive smoking cessation Web site with an online social network ( enhanced Internet ) alone and in conjunction with proactive telephone counseling ( enhanced Internet plus phone ) to a static Internet comparison condition ( basic Internet ) .


The analytic sample was N = 1,236 participants with complete 3-month data on all mediating variables .


The primary outcome was 30-day point prevalence abstinence ( ppa ) at 3 months .


Recognizing the importance of temporal precedence in mediation analyses , we also present findings for 6-month outcomes .


Purported mediators were treatment utilization and changes in psychosocial constructs .


Proposed moderators included baseline demographic , smoking , and psychosocial variables .


Mediation analyses examined the extent to which between-arm differences in 30-day ppa could be attributed to differential Web site utilization , telephone counseling , and associated changes in smoking self-efficacy and social support for quitting .


Effect modification analyses fitted interactions between treatment and prespecified moderators on abstinence .


Significant mediators of 30-day ppa were changes in smoking temptations , quitting confidence , and positive and negative partner support , which were strongly associated with increased Web site utilization .


The addition of telephone counseling to an enhanced Web site further improved abstinence rates , partly via an association with increased quitting confidence .


Baseline smoking rate was the only significant moderator .


Increased treatment utilization and associated changes in several psychosocial measures yielded higher abstinence rates .


Findings validate the importance of treatment utilization , smoking self-efficacy , and social support to promote abstinence .


Ayurveda ( Indian-complimentary and alternative medicine ) is still most sought after in India and has promising potential in management of Vishada [ major depressive disorder ( MDD ) ] .


But , systematic research is lacking .


In this study we evaluated of influence of ayurvedic treatment ( Panchakarma and Ayushman-15 ) on psychopathology , heart rate variability ( HRV ) and endocrinal parameters in patients with major depression .


81 drug naive patients diagnosed as Vishada by ayurvedic physician and MDD according to DSM IV-TR were given ayurvedic Virechana module ( therapeutic purgation ) and were randomized into two groups .


Patients in group A ( n = 41 ) received Ayushman-15A while group B ( n = 40 ) received Ayushman-15B for two months and Shirodhara ( forehead-oil pouring therapy ) .


Patients were assessed with Hamilton Depression Rating Scale ( HDRS ) , Montgomery Asberg Depression Rating Scale ( MADRS ) , Heart Rate Variability ( HRV ) .


Cortisol and adrenocorticotropic hormone ( ACTH ) were estimated at baseline and after ayurvedic therapy .


HRV and endocrinal parameters were compared with age and gender matched healthy volunteers .


HRV parameters showed significant sympathetic dominance in patients compared to healthy volunteers .


Two months of ayurvedic treatment significantly decreased psychopathology , showed increase in vagal tone , decrease in sympathetic tone and reduced cortisol levels .


However , there was no significant difference between groups receiving Ayushman A and B.


This study provides evidence for antidepressant , cardiac ( HRV ) and beneficial neuroendocrine modulatory influence of Ayurveda therapy in patients of Vishada ( MDD ) .


Further studies are needed to confirm these findings .


Greater insight into the neurobiology behind this therapy might provide valuable information about newer drug target .


Gestational diabetes mellitus ( GDM ) is a risk factor for the development of type 2 diabetes .


Lifestyle intervention can prevent progression to type 2 diabetes in high risk populations .


We designed a randomised controlled trial ( RCT ) to evaluate the effectiveness of an established lifestyle intervention compared to standard care for delaying diabetes onset in European women with recent GDM .


Recruitment into the RCT was more challenging than anticipated with only 89 of 410 ( 22 % ) women agreeing to participate .


This paper identifies factors that could enhance participation of the target population in future interventions .


We hypothesised that women who agreed to participate would have higher diabetes risk profiles than those who declined , and secondly that it would be possible to predict participation on the bases of those risk factors .


To test our hypothesis , we identified the subset of women for whom we had comprehensive data on diabetes risks factors 3-5 years following GDM , reducing the sample to 43 participants and 73 decliners .


We considered established diabetes risk factors : smoking , daily fruit and vegetable intake , participation in exercise , family history of diabetes , glucose values and BMI scores on post-partum re-screens , use of insulin during pregnancy , and age at delivery .


We also analysed narrative data from 156 decliners to further understand barriers to and facilitators of participation .


Two factors differentiated participants and decliners : age at delivery ( with women older than 34 years being more likely to participate ) and insulin use during pregnancy ( with women requiring the use of insulin in pregnancy less likely to participate ) .


Binary logistic regression confirmed that insulin use negatively affected the odds of participation .


The most significant barriers to participation included the accessibility , affordability and practicality of the intervention .


Women with recent GDM face multiple barriers to lifestyle change .


Intervention designers should consider : ( i ) the practicalities of participation for this population , ( ii ) research designs that capitalise on motivational differences between participants , ( iii ) alleviating concerns about long-term diabetes management .


We hope this work will support future researchers in developing interventions that are more relevant , effective and successful in recruiting the desired population .


Current Controlled Trials ISRCTN41202110 .


This study aimed to evaluate the effects of phyto-supplements on hyperlipidemia .


For this study 191 patients , affected by hyperlipidemia , attending the Outpatient Clinics of Clinical Medicine Department , were recruited .


The patients were divided in two groups .


The first group ( 80 ) has been treated with hypolipidic diet for six months ( group D ) .


The second one ( 111 ) has been administered with hypolipidic diet and supplement ( red yeast , guggulsterones , flavonoid , sylimarin ) ( group E ) .


Anthropometric measurements and bioimpedance analysis were evaluated before and after treatment .


Moreover , total cholesterol , LDL , HDL , triglycerides ( TG ) and hepatic transaminases ( AST , ALT ) were measured before , after 3 and 6 months of treatment .


D group showed a significant reduction in BMI ( 32.6 0.7 vs. 34.3 0.7 kg/m ) , waist circumference ( 104.4 1.6 vs. 108.3 1.5 cm ) , hip circumference ( 107.9 1.1 vs. 111.2 1.1 cm ) , total cholesterol ( 214.2 3.7 vs. 236.6 2.2 mg/dL , -9.4 68.2 % ) , LDL cholesterol ( 133 3 vs. 152.9 2.8 mg/dL , -13 7.1 % ) .


E group showed a significant reduction in BMI ( 30.2 0.7 vs. 32.6 0.6 kg/m ) , waist circumference ( 94.5 1.6 vs. 101.3 1.3 cm ) , hip circumference ( 106.6 1.1 vs. 110.5 1 cm ) , total cholesterol ( 212.4 3.7 vs. 256.9 2.1 mg/dL , -17.3 76.2 % ) , LDL cholesterol ( 133.4 3.4 vs. 168.4 2.3 mg/dL , -20.8 47.8 % ) .


Low fat diet , associated to phyto-substance supplement , have been proven useful to decrease serum cholesterol level and to improve nutritional status .


Long-lasting low back pain is an increasing problem , and for some patients surgery is the final option for improvement .


Several techniques for spinal fusion are available and the optimal technique remains uncertain .


The objective of this study was to assess the cost-effectiveness and cost-utility of transforaminal lumbar interbody fusion ( TLIF ) compared to posterolateral instrumented fusion ( PLF ) from the societal perspective .


100 Patients were randomized to TLIF or PLF ( 51/49 ) and followed for 2years .


Cost data were acquired from national registers , and outcomes were measured using the Oswestry Disability Index and SF-6D questionnaires .


Conventional cost-effectiveness methodology was employed to estimate net benefit and to illustrate cost-effectiveness acceptability curves .


The statistical analysis was based on means and bootstrapped confidence intervals .


Results showed no statistically significant difference in either cost or effects although a tendency for the TLIF regimen being more costly on bed days ( <euro> 2,554 ) and production loss ( <euro> 1,915 ) was observed .


The probability that TLIF would be cost-effective did not exceed 30 % for any threshold of willingness to pay per quality-adjusted life year .


Sensitivity analysis was conducted and supported the statistical model for handling of missing data .


TLIF does not seem to be a relevant alternative to PLF from a socioeconomic , societal point of view .


According to international treatment guidelines , inhaled rapid-acting 2 agonists should be used for the control of symptoms in patients with asthma .


We compared the efficacy and safety of an extrafine combination inhaler containing a corticosteroid ( beclometasone ) plus a rapid-onset , long-acting 2 agonist ( formoterol ) with a short-acting 2 agonist ( salbutamol ) as reliever strategies in patients taking beclometasone-formoterol combination as maintenance treatment .


In a double-blind trial undertaken in 183 centres in 14 European countries over 48 weeks , patients ( aged 18 years ) with asthma that was not fully controlled , with a forced expiratory volume in 1 s ( FEV1 ) of at least 60 % predicted , had a 2-week run in .


During this period , patients were treated with a combination of beclometasone 100 g and formoterol 6 g per one inhalation twice daily plus salbutamol 100 g as required delivered by use of a pressurised metered-dose inhaler .


They were then randomly assigned in a 1:1 ratio with a computer-generated randomisation list to receive beclometasone 100 g plus formoterol 6 g or salbutamol 100 g as reliever in addition to maintenance with beclometasone 100 g plus formoterol 6 g twice daily .


Primary outcome was the time to first severe exacerbation ( admission to hospital or visit to emergency department , or use of systemic steroids for 3 consecutive days ) .


Secondary outcomes were number of severe exacerbations ( events per 100 patients per year ) , time to and number of mild exacerbations , additional exacerbation variables , lung function , symptom scores , and asthma control .


Analysis was by intention to treat .


The study is registered with ClinicalTrials.gov , number NCT00861926 .


1714 patients were randomly assigned to the as-needed beclometasone-formoterol ( n = 857 ) and as-needed salbutamol groups ( n = 857 ) , and 1701 were analysed ( 852 and 849 , respectively ) .


326 severe exacerbations were reported by 251 patients during the study , and 99 versus 152 patients had at least one exacerbation during the 48 weeks , respectively .


Compared with beclometasone-formoterol plus salbutamol as needed , beclometasone-formoterol for both maintenance and reliever treatment significantly increased the time to first exacerbation ( 209 days vs 134 days ) by 75 days , with a 36 % reduction in risk ( hazard ratio 064 [ 95 % CI 049 to 082 ] ; p = 00005 ) , and the estimated probability was 12 % and 18 % , respectively ( p = 00003 ) .


The number of days with mild asthma exacerbations was also lower with as-needed beclometasone-formoterol than with as-needed salbutamol ( 5604 days per patient per year vs 6511 days per patient per year ; 086 [ 076 to 098 ] ; p = 0021 ) .


From the run-in period to week 48 , both treatments improved symptoms ( mean change -159 [ -194 to -125 ] in the as-needed beclometasone-formoterol group vs -144 [ -178 to -110 ] in the as-needed salbutamol group , difference -015 [ -060 to 030 ] ; p = 0507 ) , percentage of asthma control days ( 95 % [ 73 to 118 ] vs 109 % [ 87 to 131 ] , respectively , -14 [ -43 to 16 ] ; p = 0359 ) , use of reliever ( -029 [ -038 to -020 ] vs -027 [ -036 to -019 ] , respectively , -002 [ -013 to 010 ] ; p = 0794 ) , and lung function ( FEV1 , 0090 [ 0060 to 0120 ] vs 0090 [ 0060-0120 ] , respectively , 0001 [ -0040 to 0040 ] ; p = 0969 ) , and were well tolerated ( patients with serious adverse events , 32 [ 4 % ] and 41 [ 5 % ] , respectively ) .


Our results lend support to the use of the combination of a single inhaled corticosteroid plus a rapid-onset , long-acting 2 agonist for maintenance and relief in patients with moderate to severe asthma and provide encouraging data for the formulation of beclometasone-formoterol for this use .


Chiesi Farmaceutici .


To compare the delivery and retention of triclosan in dental plaque , and to compare the antibacterial efficacy of a newly developed toothpaste to a marketed calcium carbonate toothpaste .


Two clinical delivery/retention studies were carried out to determine the concentration of triclosan in plaque 10 minutes , and two and four hours after brushing with a new triclosan-containing toothpaste with magnesium aluminium silicate or a marketed triclosan-containing toothpaste .


Both studies had a double-blind , randomized , complete cross-over design .


Supragingival plaque samples ( minimum 2 microg ) were taken from smooth surfaces of all teeth ( 1-7 ) in all four quadrants for the 10-minute plaque measurements and in two randomly allocated quadrants at the two - and four-hour time points .


Triclosan concentration was measured by HPLC .


Antibacterial efficacy was evaluated in vitro using a biofilm formation approach .


Three replicate experiments were carried out to check for repeatability and consistency of the assay .


Toothpaste slurries were prepared by stirring one part by weight of each toothpaste with two parts by weight of deionized water .


An overnight culture suspension of Streptococcus mutans ( ATCC 25175 ) was prepared and then adjusted to give a bacterial count of approximately 10 ( 7 ) CFU/ml .


Sterile HAP discs were used as substrate and treated with the toothpaste slurry before inoculation with the standardized culture suspension of S. mutans .


Following incubation in brain heart infusion ( BHI ) broth containing 2 % sucrose for four hours , standard Total Viable Count ( TVC ) procedures were carried out and colonies counted ( log10 values ) .


Brushing with the new calcium carbonate/triclosan toothpaste resulted in a higher triclosan concentration in plaque after 10 minutes , and two and four hours compared to a marketed triclosan toothpaste .


The increase ranged from 14 % to 35 % and was statistically significant ( p < 0.05 ) .


The antibacterial efficacy of the new calcium carbonate/triclosan toothpaste , measured four hours after application , was greater than that of a marketed toothpaste with 0.3 % triclosan .


The difference was statistically significant ( p < 0.05 ) .


The new calcium carbonate toothpaste with 0.3 % triclosan and magnesium aluminium silicate demonstrated significantly greater efficacy four hours post-brushing both in terms of in vivo delivery and in vitro antibacterial action compared to a marketed calcium carbonate toothpaste with 0.3 % triclosan .


Children with congenital hemiparesis have unilateral upper extremity involvement , limiting their ability in unilateral or bilateral manual tasks , thus negatively influencing their participation in daily activities .


Constraint-induced movement therapy ( CIMT ) has been shown to be promising for improving upper-limb functions in children with cerebral palsy .


Clinical assessments may be needed to quantify and qualify changes in children 's performance following its application .


This study investigated the effectiveness of a child-friendly form of CIMT to improve upper extremity functional performance .


Thirty congenitally hemiparetic children aged 4-8 years were randomly assigned to receive either a CIMT program ( study group ) or a conventional non-structured therapy program ( control group ) .


The programs were applied for both groups for six hours daily , five days weekly for four successive weeks .


The Pediatric Arm Function Test , Quality of Upper Extremity Skills Test , and isokinetic muscular performances of shoulder flexors , extensors , and abductors expressed as peak torque were used to evaluate immediate and long-lasting efficacy of CIMT .


The results showed improvement in the involved upper extremity performances in different evaluated tasks immediately post-CIMT program application compared with the control group .


These improvements continued three months later .


Pediatric CIMT with shaping produced considerable and sustained improvement in the involved upper extremity movements and functions in children with congenital hemiparesis .


While opioids provide effective analgesia , opioid-induced constipation ( OIC ) can severely impact quality of life and treatment compliance .


This pooled analysis evaluated the maintenance of efficacy and safety during long-term treatment with combined oxycodone/naloxone prolonged-release tablets ( OXN PR ) in adults with moderate-to-severe chronic pain .


Patients ( N = 474 ) received open-label OXN PR during 52-week extension phases of two studies , having completed 12-week , double-blind , randomized treatment with oxycodone prolonged-release tablets ( Oxy PR ) or OXN PR .


Analgesia and bowel function were assessed at each study visit using ` Average pain over last 24h scale and Bowel Function Index ( BFI ) , respectively .


Treatment Satisfaction Questionnaire for Medication was assessed at study end only .


Improvement in bowel function was particularly marked in patients who switched from Oxy PR in the double-blind phase to OXN PR during the extension phase , resulting in a clinically meaningful reduction ( 12 points ) in BFI score : at the start of the extension phases , mean ( SD ) BFI score was 44.3 ( 28.13 ) , and was 29.8 ( 26.36 ) for patients who had received OXN PR in the double-blind phase .


One week later , BFI scores were similar for the two groups ( 26.5 [ 24.40 ] and 27.5 [ 25.60 ] , respectively ) , as was observed throughout the following months .


Fewer than 10 % of patients received laxatives regularly .


Mean 24-h pain scores were low and stable throughout the extension phases .


No unexpected adverse events were observed .


Pooled data demonstrate OXN PR is an effective long-term therapy for patients with chronic non-cancer pain , and can address symptoms of OIC .


No new safety issues were observed which were attributable to the long-term administration of OXN PR .


To assess pooled golimumab safety up to year 3 of rheumatoid arthritis ( RA ) , psoriatic arthritis ( PsA ) and ankylosing spondylitis ( AS ) trials .


Golimumab 50 and 100 mg , administered subcutaneously ( SC ) every 4 weeks ( q4wk ) , were assessed in patients with active RA ( methotrexate-nave , methotrexate-experienced and anti-TNF ( tumour necrosis factor ) - experienced ) , PsA or AS , despite conventional therapy .


Placebo control continued up to week ( wk ) 24 ( wk 52 , methotrexate-nave ) , with early escape at wk 16 ( wk 28 , methotrexate-nave ) ; subsequently , all patients received golimumab 50 or 100 mg q4wk .


After the blinded controlled period , golimumab doses could be adjusted per investigator discretion .


Pooled safety analyses reported herein include data from placebo-controlled and uncontrolled study periods up to wk 160 .


Determinations of incidences/100 patient-years ( pt-yrs ) for rare events also included RA patients from a phase IIb trial .


Across five phase III trials of SC golimumab , 639 patients received placebo and 2226 received golimumab 50 mg ( n = 1249 ) and/or 100 mg ( n = 1501 ) up to wk 160 ( patients may be included in more than one group because non-responders were allowed early escape ) ; 1179 patients were treated for 156 weeks .


For placebo , golimumab 50 mg and golimumab 100 mg , respective adverse event incidences/100 pt-yrs ( 95 % CIs ) up to wk 160 were : 0.28 ( 0.01 to 1.56 ) , 0.30 ( 0.12 to 0.62 ) , 0.41 ( 0.23 to 0.69 ) for death ; 5.31 ( 3.20 to 8.30 ) , 3.03 ( 2.36 to 3.82 ) , 5.09 ( 4.36 to 5.90 ) for serious infection ; 0.00 ( 0.00 to 0.84 ) , 0.17 ( 0.05 to 0.44 ) , 0.35 ( 0.18 to 0.62 ) for tuberculosis ; 0.00 ( 0.00 to 0.84 ) , 0.13 ( 0.03 to 0.38 ) , 0.24 ( 0.10 to 0.46 ) for opportunistic infection ; 0.00 ( 0.00 to 0.84 ) , 0.00 ( 0.00 to 0.13 ) , 0.12 ( 0.03 to 0.30 ) for demyelination ; and 0.00 ( 0.00 to 0.84 ) , 0.04 ( 0.00 to 0.24 ) , 0.18 ( 0.06 to 0.38 ) for lymphoma .


SC golimumab safety up to 3 years remained consistent with that of other TNF antagonists .


Golimumab 100 mg showed numerically higher incidences of serious infections , demyelinating events and lymphoma than 50 mg ; safety follow-up up to year 5 continues .


This study investigates the effect of aerobic interval training on diastolic function at rest and during exercise in stable heart transplant ( HTx ) recipients .


Twenty-three stable HTx recipients ( 74 % males , mean age 50 14.9 years ) were recruited to a training programme .


Intervention was 8 weeks intensive training or control in a randomized controlled design .


At baseline , participants had normal or mild diastolic dysfunction at rest .


During exercise , mean E/e ' increased from 9.0 ( 2.8 ) to 12.8 ( 7.7 ) ( p = 0.09 ) , E/A increased from 2.1 ( 0.6 ) to 2.6 ( 0.7 ) ( p = 0.02 ) , and deceleration time decreased by over 50 ms , all markers of increased filling pressure .


There were no correlations between diastolic function and VO 2 peak at baseline .


After intervention VO 2 peak increased from 23.9 ( 4.5 ) to 28.3 ( 6 ) ml/kg/min in the training group ( difference between groups p = 0.0018 ) .


No consistent pattern of improvement in diastolic function at rest or during exercise was seen .


The study does not support a role of diastolic dysfunction in the limited exercise capacity of HTx recipients and suggests that in these patients peripheral factors are of greater importance .


Pulmonary rehabilitation ( PR ) is a multidisciplinary program of care for patients with chronic obstructive pulmonary disease ( COPD ) with the goal of improving the functional capacity and quality of life , as well as maintaining the clinical stability of COPD sufferers .


However , not all patients are available for such a program despite discomfort with their condition .


The aim of this study was to evaluate the effects of a home-based PR ( HBPR ) program on functional ability , quality of life , and respiratory muscle strength and endurance .


Patients with COPD according to the Global Initiative of Chronic Obstructive Lung Disease were randomized ( double-blind ) into two groups .


One group performed a protocol at home with aerobic and muscle strength exercises and was called the intervention group ; the other group received only instructions to perform breathing and stretching exercises , characterizing it as the control group ( CG ) .


We assessed the following variables at baseline and 2 months : exercise tolerance ( incremental shuttle walk test and upper limb test ) , respiratory muscle ( strength and endurance test ) , and health-related quality of life ( Airways Questionnaire 20 ) .


There were no significant changes after the intervention in either of the two groups in exercise tolerance and quality of life .


However , the intervention group had improved respiratory endurance compared with the CG , while the CG presented a decrease in the load sustained by the respiratory muscles after the HBPR .


A program of HBPR with biweekly supervision ( although not enough to provide significant improvements in physical capacity or quality of life ) played an important role in maintaining the stability of the clinical features of patients with COPD ; the patients had no worsening of symptoms during the intervention period according to the daily log .


The pattern of atrial fibrillation ( AF ) occurrence-paroxysmal , persistent , or permanent-is associated with progressive stages of atrial dysfunction and structural changes and may therefore be associated with progressively higher stroke risk .


However , previous studies have not consistently shown AF pattern to predict stroke but have been hampered by methodological shortcomings of low power , variable event ascertainment , and variable anticoagulant use .


We analysed the rates of stroke and systemic embolism in 6563 aspirin-treated patients with AF from the ACTIVE-A/AVERROES databases .


There was thorough searching for events and adjudication .


Multivariable analyses were performed with the adjustment for known risk factors for stroke .


Mean age of patients with paroxysmal , persistent , and permanent AF was 69.0 9.9 , 68.6 10.2 , and 71.9 9.8 years ( P < 0.001 ) .


The CHA2DS2-VASc score was similar in patients with paroxysmal and persistent AF ( 3.1 1.4 ) , but was higher in patients with permanent AF ( 3.6 1.5 , P < 0.001 ) .


Yearly ischaemic stroke rates were 2.1 , 3.0 , and 4.2 % for paroxysmal , persistent , and permanent AF , respectively , with adjusted hazard ratio of 1.83 ( P < 0.001 ) for permanent vs. paroxysmal and 1.44 ( P = 0.02 ) for persistent vs. paroxysmal .


Multivariable analysis identified age 75 year , sex , history of stroke or TIA , and AF pattern as independent predictors of stroke , with AF pattern being the second strongest predictor after prior stroke or TIA .


In a large population of non-anticoagulated AF patients , pattern of AF was a strong independent predictor of stroke risk and may be helpful to assess the risk/benefit for anticoagulant therapy , especially in lower risk patients .


In the process of behaviour change , intonation of speech is an important aspect that may influence persuasion when auditory messages are used .


In two experiments , we tested to what extent different levels of intonation are related to persuasion and whether for some recipients the threat posed by the message information might become too strong to face .


In Study 1 , 130 respondents listened to a health message with either a low , moderate or high level of intonation .


In Study 2 ( N = 143 ) , the same manipulations of intonation were applied but half of the respondents were affirmed before they listened to the persuasive message .


Intention to increase fruit and vegetable intake was used as a dependent variable .


Both studies showed that high intonation led to a significant drop in intention among respondents who perceived their own health as good .


After self-affirmation , persuasion was increased .


A high level of intonation seems to induce self-regulatory defences in people who do not see the necessity to change their health behaviour , whereas people with poor perceived health might perceive potential to change .


The use of a normal level of intonation in auditory health messages is recommended .


The aim of this randomized clinical trial was to evaluate the efficacy of a mouthrinse containing 1.4 % potassium oxalate ( Listerine Advanced Defence Sensitive ; LADS ) plus Colgate Cavity Protection Regular toothpaste , in reducing dentin sensitivity .


This was an observer - and examiner-blinded , randomized , parallel-group , single-center , controlled , five-day clinical trial .


Healthy adults were randomized ( 2:1:1 ) to LADS plus Colgate Cavity Protection Regular toothpaste , or to one of the two negative-control toothpastes alone : Crest Cavity Protection Regular or Colgate Cavity Protection Regular .


The subjects carried out supervised and unsupervised brushing and rinsing twice a day .


Dentin sensitivity was assessed at baseline and during treatment by Yeaple probe ( tactile pressure ; patient-reported discomfort by visual analogue scale [ VAS ] ) , as well as response to air blasts ( VAS ) .


All sensitivity assessments were similar at baseline in the 56 randomized subjects .


By the third day , the Yeaple probe sensitivity scores for subjects treated with Colgate toothpaste plus LADS improved significantly compared to Crest toothpaste alone ( p < 0.05 ) .


By the fifth day , the mean scores for subjects treated with Colgate toothpaste plus LADS were significantly improved compared with subjects treated with either toothpaste alone ( p < 0.05 ) .


The other sensitivity assessments showed that Colgate toothpaste plus LADS achieved statistically significant improvements compared with Colgate and/or Crest toothpaste alone from the third day .


The 1.4 % potassium oxalate mouthrinse ( LADS ) was associated with a reduction in dentinal sensitivity within a five-day period .


Statistically significant reductions in all sensitivity variables were achieved by Day 3 and even greater reductions in dentin sensitivity scores were observed after five days .


The COPE-ICD ( Copenhagen Outpatient ProgrammE-implantable cardioverter defibrillator ) trial studied comprehensive cardiac rehabilitation for patients with ICDs .


The purpose of this paper was to explore : ( 1 ) gender differences in self-rated health and quality of life ( QoL ) at hospital discharge after ICD implantation , ( 2 ) gender differences in effect of cardiac rehabilitation , and ( 3 ) predictors of effect of cardiac rehabilitation .


Patients with first-time ICD implantation were randomized to comprehensive cardiac rehabilitation versus usual care .


Gender differences in self-rated health and QoL and effect of rehabilitation were tested using t-tests .


Predictors of effect of rehabilitation were tested using logistic regression .


A total of 196 patients ( mean age 58 13 years ; 155 men , 41 women ) were included .


At hospital discharge , significant differences were found in physical component scale , mental component scale , social functioning , physical functioning , bodily pain , vitality , mental health , and QoL with men having higher scores .


Among men only , significant differences were found in VO2 ( rehabilitation : 20.9 mL/min/kg [ standard deviation ( SD ) 8.1 ] vs 23.4 mL/min/kg [ SD 9.5 ] and usual care : 22.1 mL/min/kg [ SD 8.1 ] vs 21.8 mL/min/kg [ SD 8.3 ] , P = 0.01 ) , total exercise time ( rehabilitation : 587.0 seconds [ SD 249.6 ] vs 650.7 seconds [ SD 279.8 ] and usual care : 613.8 seconds [ SD 264.7 ] vs 606.1 seconds [ SD 277.3 ] , P = 0.01 ) , and the mental component scale ( rehabilitation : 47.7 points [ SD 10.1 ] vs 54.8 points [ 7.1 ] and usual care : 48.1 points [ SD 10.9 ] vs 51.9 points [ SD 9.6 ] , P = 0.05 ) .


After ICD implantation , significant gender differences were found in physical health , mental health , and QoL .


Effects of rehabilitation were found among men only and gender predicted effect of rehabilitation on the mental component scale .


To compare the analgesic effects of intra-articularly administered saline ( 0.9 % NaCl ) solution , morphine , dexmedetomidine , and a morphine-dexmedetomidine combination in dogs undergoing stifle joint surgery for cranial cruciate ligament rupture .


Randomized , controlled , clinical trial .


44 dogs with cranial cruciate ligament rupture that underwent tibial tuberosity advancement ( TTA ) or tibial plateau leveling osteotomy ( TPLO ) .


Dogs received intra-articular injections of saline solution ( 0.2 mL/kg [ 0.09 mL/lb ] ) , morphine ( 0.1 mg/kg [ 0.045 mg/lb ] ) , dexmedetomidine ( 2.5 g/kg [ 1.14 g/lb ] ) , or a combination of morphine ( 0.1 mg/kg ) and dexmedetomidine ( 2.5 g/kg ) .


Intra-articular injections of the stifle joint were performed after completion of the corrective osteotomy procedure , just prior to skin closure .


Signs of pain were assessed every 2 hours thereafter on the basis of mean behavioral and objective pain scores .


Dogs with pain scores exceeding predetermined thresholds were given hydromorphone ( 0.05 mg/kg [ 0.023 mg/lb ] , SC ) as rescue analgesia .


Time to rescue analgesia did not significantly differ between dogs that underwent TTA versus TPLO .


No significant difference in time to rescue analgesia was found among dogs receiving intra-articular injections of dexmedetomidine ( median , 6 hours ; range , 2 to 10 hours ) , morphine ( median , 7 hours ; range , 4 to 10 hours ) , or saline solution ( median , 5 hours ; range , 4 to 10 hours ) .


However , time to rescue analgesia for dogs receiving intra-articular injection of the morphine-dexmedetomidine combination ( median , 10 hours ; range , 6 to 14 hours ) was significantly longer than the time to rescue analgesia for other treatment groups .


Intra-articular administration of the morphine-dexmedetomidine combination provided longer-lasting postoperative analgesia , compared with either morphine or dexmedetomidine alone , in dogs undergoing TTA or TPLO .


Ninety lower-limb stage II or worse TAO patients were randomly divided into three groups : group A ( 30 cases ) treated by intervention and oral administration of Chinese medicine ; group B ( 30 cases ) treated by intervention alone ; and group C ( 30 cases ) treated only with oral administration of Chinese medicine .


Therapeutic effects were observed , including the cure rate ; the recurrence rate after one month , three months , six months , nine months , and one year ; the ankle brachial indexes ; the incidence of complications ; and the level of C-reactive protein and erythrocyte sedimentation rate .


Group A had significantly better clinically curative effects , related indexes , and outcomes during the long-term follow-up survey , than that of groups B and C.


Integrated treatment is more effective for treating lower-limb stage II or worse TAO .


To observe if integrated treatment is better than other therapies for lower-limb stage II thromboangiitis obliterans ( TAO ) .


Results of the SYMPLICITY HTN-3 ( Renal Denervation in Patients With Uncontrolled Hypertension ) trial confirmed the safety but not the efficacy of renal denervation for treatment-resistant hypertension at 6 months post procedure .


This study sought to analyze the 12-month SYMPLICITY HTN-3 results for the original denervation group , the sham subjects who underwent denervation after the 6-month endpoint ( crossover group ) , and the sham subjects who did not undergo denervation after 6 months ( non-crossover group ) .


Eligible subjects were randomized 2:1 to denervation or sham procedure .


Subjects were unblinded to their treatment group after the 6-month primary endpoint was ascertained ; subjects in the sham group meeting eligibility requirements could undergo denervation .


Change in blood pressure ( BP ) at 12 months post randomization ( 6 months for crossover subjects ) was analyzed .


The 12-month follow-up was available for 319 of 361 denervation subjects and 48 of 101 non-crossover subjects ; 6-month denervation follow-up was available for 93 of 101 crossover subjects .


In denervation subjects , the 12-month office systolic BP ( SBP ) change was greater than that observed at 6 months ( -15.5 24.1 mm Hg vs.-18 .9 25.4 mmHg , respectively ; p = 0.025 ) , but the 24-h SBP change was not significantly different at 12 months ( p = 0.229 ) .


Thenon-crossover group office SBP decreased by-32 .9 28.1 mmHg at 6 months , but this response regressed to-21 .4 19.9 mmHg ( p = 0.01 ) at 12 months , increasing to 11.5 29.8 mmHg .


These data support no further reduction in office or ambulatory BP after 1-year follow-up .


Loss of BPreduction in the non-crossover group may reflect decreased medication adherence or other related factors .


( Renal Denervation in Patients With Uncontrolled Hypertension [ SYMPLICITY HTN-3 ] ; NCT01418261 ) .


Effective interventions to improve immunosuppressive medication adherence among adolescent and young adult kidney transplant recipients are desperately needed .


This paper describes the aims , design , and methods of the Teen Adherence in Kidney transplant , Effectiveness of Intervention Trial ( TAKE-IT ) study .


TAKE-IT is a multicentre , prospective , open-label , parallel arm randomized controlled trial that aims to determine the effectiveness of a clinic-based intervention , including educational , organizational , and behavioural components , in improving immunosuppressive medication adherence among adolescent and young adult kidney transplant recipients .


Individuals between 11 and 24 years of age who are at least 3 months post-transplant and followed in one of the eight participating pediatric kidney transplant programs , or their affiliated adult transplant programs are eligible to participate .


All participating centers are tertiary care pediatric hospitals in Canada or the United States .


Adherence is monitored using an electronic multi-dose pillbox for all participants during a 3-month run-in period , followed by a 12-month intervention interval .


The primary outcome is ` taking adherence ' , defined as the proportion of prescribed doses of immunosuppressive medications that were taken , as measured using electronic monitoring.All participants meet with the study ` Coach ' at 3 month intervals .


The intervention , administered by trained lay personnel , targets common adherence barriers .


In addition to forming an Adherence Support Team , intervention participants identify personal barriers to adherence and use Action-focused problem-solving to address them , have their electronic adherence data fed back to them , and have the option to receive email , text message , or visual cue dose reminders .


Participants in the control group meet with the coach but do not receive the other components of the intervention .


The study aims to have 75 participants in each group complete the study .


Since recruitment began in Feb. 2012 , 198 adolescents have been approached to participate , of whom 130 have completed a baseline visit .


As of March 31 , 2014 , 125 had been randomized , and 86 , 68 , 61 , and 50 participants had completed 6-month , 9-month , 12-month , and 15-month visits respectively .


Clinicaltrials.gov registration NCT01356277 ( May 17 , 2011 ) .


The aim of the study was to investigate 4-year outcomes and predictors of repeat revascularization in patients treated with the Resolute zotarolimus-eluting stent ( R-ZES ) ( Medtronic , Minneapolis , Minnesota ) and XIENCE V everolimus-eluting stent ( EES ) ( Abbott Vascular , Abbott Park , Illinois ) in the RESOLUTE ( A Randomized Comparison of a Zotarolimus-Eluting Stent With an Everolimus-Eluting Stent for Percutaneous Coronary Intervention ) All-Comers trial .


Data on long-term outcomes of new-generation drug-eluting stents are limited , and predictors of repeat revascularization due to restenosis and/or progression of disease are largely unknown .


Patients were randomly assigned to treatment with the R-ZES ( n = 1,140 ) or the EES ( n = 1,152 ) .


We assessed pre-specified safety and efficacy outcomes at 4 years including target lesion failure and stent thrombosis .


Predictors of revascularization at 4 years were identified by Cox regression analysis .


At 4 years , the rates of target lesion failure ( 15.2 % vs. 14.6 % , p = 0.68 ) , cardiac death ( 5.4 % vs. 4.7 % , p = 0.44 ) , and target vessel myocardial infarction ( 5.3 % vs. 5.4 % , p = 1.00 ) , clinically-indicated target lesion revascularization ( TLR ) ( 7.0 % vs. 6.5 % , p = 0.62 ) , and definite/probable stent thrombosis ( 2.3 % vs. 1.6 % , p = 0.23 ) were similar with the R-ZES and EES .


Independent predictors of TLR were age , insulin-treated diabetes , SYNTAX ( Synergy between PCI with Taxus and Cardiac Surgery ) score , treatment of saphenous vein grafts , ostial lesions , and in-stent restenosis .


Independent predictors of any revascularization were age , diabetes , previous percutaneous coronary intervention , absence of ST-segment elevation myocardial infarction , smaller reference vessel diameter , SYNTAX score , and treatment of left anterior descending , right coronary artery , saphenous vein grafts , ostial lesions , or in-stent restenosis .


R-ZES and EES demonstrated similar safety and efficacy throughout 4 years .


TLR represented less than one-half of all repeat revascularization procedures .


Patient - and lesion-related factors predicting the risk of TLR and any revascularization showed considerable overlap .


( A Randomized Comparison of a Zotarolimus-Eluting Stent With an Everolimus-Eluting Stent for Percutaneous Coronary Intervention [ RESOLUTE-AC ] ; NCT00617084 ) .


This was a randomized , open-label , three-way crossover study to assess the effects of AST-120 ( an orally administered spherical carbon adsorbent acting in the gastrointestinal tract without systemic circulation ) on the single-dose pharmacokinetics of metoprolol in an extended-release formulation ( metoprolol ER ) in healthy volunteers .


A total of 34 subjects were singly administered metoprolol ER alone ( A ) , and metoprolol ER in combination with AST-120 simultaneously ( B ) and 1 h later ( C ) .


The total exposure was more significantly reduced in both treatments B and C than that in treatment A ; the geometric mean ratios of area under the curve extrapolated to infinity ( AUC0 - ) for B/A and C/A were reduced by approximately 30 % in both treatments B and C. Maximum observed plasma concentration ( Cmax ) of metoprolol in treatment B significantly decreased , whereas Cmax in treatment C was slightly decreased .


AST-120 treatment was unlikely to affect apparent first-order terminal elimination half-life ( T1/2 ) of metoprolol significantly .


Reduction in heart rate and blood pressure readings were similar across the treatment periods .


Coadministration of AST-120 and metoprolol ER was safe and was well tolerated .


Because AST-120 reduced gastrointestinal absorption of metoprolol ER , careful monitoring of heart rate and blood pressure is recommended in coadministration of AST-120 with metoprolol ER .


The purpose of this study was to compare the tolerance , efficacy , and safety of endobronchial ultrasound-guided transbronchial needle aspiration ( EBUS-TBNA ) with transesophageal endoscopic ultrasound-guided fine-needle aspiration ( EUS-FNA ) with an endobronchial ultrasound scope for the first pathologic diagnosis of lesions accessible by both procedures .


Patients who had lesions accessible by both EBUS-TBNA and EUS-FNA were enrolled and were randomized to undergo either procedure .


Patients quantified tolerance , and operators charted the quality of examination using a 100-mm visual analog scale ( VAS ) .


A specific diagnosis was made in 50 of 55 patients ( 91 % ) in the EBUS-TBNA group and in 48 of 55 patients ( 87 % ) in the EUS-FNA group ( P = .76 ) .


Compared with EBUS-TBNA , EUS-FNA was associated with a shorter duration of procedure ( median , 15.3 min vs 11.3 min ; P < .001 ) , lower doses of IV midazolam ( mean , 4.4 mg vs 4 mg ; P = .02 ) and intraairway lidocaine ( mean , 303 mg vs 189 mg ; P < .001 ) , less frequent oxygen desaturations ( 23 of 55 vs two of 55 , P < .001 ) , and higher operator satisfaction ( P < .001 ) .


There was no significant difference in patient tolerance according to the patients ' VAS .


Lymph node infection occurred in one patient in the EBUS-TBNA group and in two patients in the EUS-FNA group .


Both EBUS-TBNA and EUS-FNA provide high accuracy with good tolerance , although the occurrence of infectious complications should be monitored carefully .


EUS-FNA has the advantage of comparable tolerance with fewer doses of anesthetics and sedatives , a shorter procedure time , and fewer oxygen desaturations during the procedure .


UMIN Clinical Trials Registry ; No. : UMIN000005757 ; URL : http://www.umin.ac.jp/ctr/ .


The objective of this study was to determine the impact of nonfatal cardiovascular ( CV ) events on changes in health-related quality of life ( HRQL ) .


There is limited understanding of the impact of nonfatal CV events on long-term changes in HRQL in survivors ofmyocardial infarction ( MI ) .


The VALIANT ( Valsartan In Acute Myocardial Infarction ) trial enrolled 14,703 patients post-MI complicated by Killip class II or higher ( scale measuring heart failure severity post-MI ranging from class I to IV ) and/or reduced ejection fraction .


The HRQL substudy included 2,556 ( 17.4 % ) patients who completed the EQ-5D with 5 questions , with responses mapped to utility weight on a scale of 0 to 1 and a visual analog scale ( VAS ) ranging from 0 ( worst ) to 100 ( best ) imaginable health state .


EQ-5D was administered at baseline and 6 , 12 , 20 , and 24 months .


The trajectory of EQ-5D scores was developed by using linear mixed effects regression models with calculation of deviation from this trajectory after nonfatal CV events .


Patients who died before the next EQ-5D assessment were excluded .


Over a 2-year period , 597 patients experienced a nonfatal CV event and survived to have another EQ-5D assessment .


Their baseline EQ-5D scores were lower than patients without a subsequent nonfatal CV event ( VAS 61.0 19 vs 68.2 18 [ p < 0.001 ] and US-based utility score 0.76 0.22 vs 0.83 0.17 [ p < 0.001 ] ) .


These patients with CVevents experienced a trajectory-adjusted 6.6 point decrease ( p < 0.001 ) in VAS scores and a 0.07 decrease ( p < 0.001 ) in utility score after the nonfatal CV event .


MI survivors suffering a CV event experienced significantly worse HRQL than their previous trajectory , suggesting that generic instruments can be responsive to nonfatal events .


Reduction in nonfatal CV events may affect longitudinal changes in HRQL .


Vaccination with dendritic cells ( DC ) loaded with tumor antigens elicits tumor-specific immune responses capable of killing cancer cells without inducing meaningful side-effects .


Patients with advanced melanoma enrolled onto our phase II clinical studies have been treated with autologous DC loaded with autologous tumor lysate/homogenate matured with a cytokine cocktail , showing a clinical benefit ( PR+SD ) in 55.5 % of evaluable cases to date .


The beneficial effects of the vaccine were mainly restricted to patients who developed vaccine-specific immune response after treatment .


However , immunological responses were only induced in about two-thirds of patients , and treatments aimed at improving immunological responsiveness to the vaccine are needed .


This is a phase II , `` proof-of-principle '' , randomized , open-label trial of vaccination with autologous DC loaded with tumor lysate or homogenate in metastatic melanoma patients combined with immunomodulating RT and/or preleukapheresis IFN - .


All patients will receive four bi-weekly doses of the vaccine during the induction phase and monthly doses thereafter for up to a maximum of 14 vaccinations or until confirmed progression .


Patients will be randomized to receive : ( 1 . )


three daily doses of 8Gy up to 12Gy radiotherapy delivered to one non-index metastatic field between vaccine doses 1 and 2 and , optionally , between doses 7 and 8 , using IMRT-IMAT techniques ; ( 2 . )


daily 3 MU subcutaneous IFN - for 7days before leukapheresis ; ( 3 . )


both 1 and 2 ; ( 4 . )


neither 1 nor 2 .


At least six patients eligible for treatment will be enrolled per arm .


Daily 3 MU IL-2 will be administered subcutaneously for 5days starting from the second day after each vaccine dose .


Serial DTH testing and blood sampling to evaluate treatment-induced immune response will be performed .


Objective response will be evaluated according to immune-related response criteria ( irRC ) .


Based upon the emerging role of radiotherapy as an immunologic modifier , we designed a randomized phase II trial adding radiotherapy and/or preleukapheresis IFN - to our DC vaccine in metastatic melanoma patients .


Our aim was to find the best combination of complementary interventions to enhance anti-tumor response induced by DC vaccination , which could ultimately lead to better survival and milder toxicity .


To compare two therapeutic methods : electroacupuncture + massage + blocking therapy , and blocking therapy alone in the treatment of external humeral epicondylitis .


Eighty-six patients were randomized into two groups with 43 in each .


The treatment group received electroacupuncture + massage + blocking therapy , while the control group received blocking therapy only .


A course of electroacupuncture treatment included therapy once a day for 10 days .


There were 10 treatments in a massage course and massage was given once a day , with a 1-week interval given before the next course .


A course of blocking treatment included therapy once a week , for two total treatments , and generally no more than three times .


The therapeutic effects were evaluated with the visual analog scale ( VAS ) , grip strength index ( GSI ) score , and Mayo elbow performance score ( MEPS ) before treatment and at 0 , 6 , 12 , and 24 months after treatment to observe the total effective rate .


In the treatment and control groups before treatment and at 0 , 6 , 12 , and 24 months after treatment , the VAS scores were : 6.5 + / - 1.9 and 6.4 + / - 1.6 ; 4.6 + / - 1.3 and 4.6 + / - 1.7 ; 4.8 + / - 1.3 and 4.8 + / - 1.2 ; 4.6 + / - 1.2 and 6.6 + / - 1.6 ; and 6.5 + / - 1.6 and 6.5 + / - 1.3 , respectively .


The GSI scores were 63 + / - 8 and 63 + / - 8 ; 84 + / - 6 and 82 + / - 7 ; 82 + / - 7 and 82 + / - 6 ; 84 + / - 6 and 62 + / - 8 ; and 64 + / - 6 and 64 + / - 7 , respectively .


The MEPS of both groups were 65 + / - 7 and 66 + / - 8 ; 85 + / - 6 and 84 + / - 7 ; 84 + / - 5 and 84 + / - 7 ; 80 + / - 7 and 66 + / - 6 ; and 65 + / - 6 and 65 + / -7 , respectively .


The total effective rates of the treatment and control groups at 0 , 6 , 12 , and 24 months after treatment were 87.5 % and 85.0 % ; 85.0 % and 82.5 % ; 80.0 % and 12.5 % ; and 2.5 % and 5.0 % , respectively .


Compared with the treatment group , the control group had greater joint function , better therapeutic effect , and lower pain intensity ( P < 0.01 ) , indicating a high recurrence rate in the 12th month after treatment .


There were no differences in VAS , GSI , or MEPS at 0 , 6 , and 24 months after treatment ( P > 0.05 ) between the two groups .


We found that both methods were effective for external humeral epicondylitis .


After 6 months of treatment , the effects were good in both groups .


However , in the 12th month , the control group had a relatively severe relapse .


After 24 months , both groups relapsed .


The effect of electroacupuncture , massage , and blocking therapy used in combination lasted longer , delaying the recurrence of the disease .


The change in volume of anatomic structures is as a sensitive indicator of Alzheimer disease ( AD ) progression .


Although several methods are available to measure brain volumes , improvements in speed and automation are required .


Our objective was to develop a fully automated , fast , and reliable approach to measure change in medial temporal lobe ( MTL ) volume , including primarily hippocampus .


The MTL volume defined in an atlas image was propagated onto each baseline image and a level set algorithm was applied to refine the shape and smooth the boundary .


The MTL of the baseline image was then mapped onto the corresponding follow-up image to measure volume change ( MTL ) .


Baseline and 24 months 3D T1-weighted images from the Alzheimer Disease Neuroimaging Initiative ( ADNI ) were randomly selected for 50 normal elderly controls ( NECs ) , 50 subjects with mild cognitive impairment ( MCI ) and 50 subjects with AD to test the algorithm .


The method was compared to the FreeSurfer segmentation tools .


The average MTL ( meanSEM ) was 6835mm ( 3 ) in NEC , 18738mm ( 3 ) in MCI and 30034mm ( 3 ) in the AD group and was significantly different ( p < 0.0001 ) between all three groups .


The MTL was correlated with cognitive decline .


Results for the FreeSurfer software were similar but did not detect significant differences between the MCI and AD groups .


This novel segmentation approach is fully automated and provides a robust marker of brain atrophy that shows different rates of atrophy over 2 years between NEC , MCI , and AD groups .


Although spironolactone has been shown to decrease morbidity and mortality in patients with heart failure and reduced left ventricular ejection fraction , its role in patients with heart failure and preserved left ventricular ejection fraction ( HFpEF ) is not well defined .


In this study we investigated the mechanisms involved when elderly women with HFpEF are treated with spironolactone .


Forty-eight women with HFpEF were enrolled in a randomized placebo-controlled trial and were assigned to 25 mg spironolactone daily ( n = 24 ) or placebo ( n = 24 ) for 6 months .


Six-minute walk distance , clinical composite score , Doppler echocardiography , and biomarkers were determined at baseline and after 3 and 6 months of therapy .


Six months of spironolactone treatment stabilized clinical symptoms , as demonstrated by significant worsening of the clinical composite score in the placebo group ( P = .02 ) .


In addition , spironolactone treatment improved diastolic function by significantly increasing early diastolic tissue Doppler velocity of the lateral mitral annulus ( lateral e ' ; P = .003 ) and significantly reducing the mitral peak E velocity to lateral e ' ratio ( lateral E/e ' ; P = .0001 ) .


Finally , spironolactone favorably affected remodeling through a reduction in myocardial fibrosis measured by a reduction in type III procollagen levels ( P = .035 ) .


Six-minute walk distance did not significantly improve with spironolactone treatment compared with placebo .


Spironolactone stabilizes functional capacity and symptoms and improves diastolic function , possibly through its ability to suppress type III procollagen synthesis .


Orexin A ( OXA ) modulates food intake , energy expenditure , and lipid and glucose metabolism .


OXA regulates the secretion of insulin and glucagon , while glucose regulates OXA release .


Here , we evaluate the role of glucagon in regulating OXA release both in vivo and in vitro .


In a double-blind crossover study , healthy volunteers and type 1 diabetic patients received either intramuscular glucagon or placebo .


Patients newly diagnosed with type 2 diabetes underwent hyperinsulinaemic-euglycaemic clamp experiments , and insulin-hypoglycaemia tests were performed on healthy volunteers .


The primary endpoint was a change in OXA levels after intramuscular glucagon or placebo administration in healthy participants and patients with type 1 diabetes .


Secondary endpoints included changes in OXA in healthy participants during insulin tolerance tests and in patients with type 2 diabetes under hyperinsulinaemic-euglycaemic conditions .


Participants and staff conducting examinations and taking measurements were blinded to group assignment .


OXA secretion in response to glucagon treatment was assessed in healthy and obese mice , the streptozotocin-induced mouse model of type 1 diabetes , and isolated rat pancreatic islets .


Plasma OXA levels declined in lean volunteers and in type 1 diabetic patients injected with glucagon .


OXA levels increased during hyperinsulinaemic hypoglycaemia testing in healthy volunteers and during hyperinsulinaemic euglycaemic conditions in type 2 diabetic patients .


Plasma OXA concentrations in healthy lean and obese mice and in a mouse model of type 1 diabetes were lower after glucagon treatment , compared with vehicle control .


Glucagon decreased OXA secretion from isolated rat pancreatic islets at both low and high glucose levels .


OXA secretion declined in pancreatic islets exposed to diazoxide at high and low glucose levels , and after exposure to an anti-insulin antibody .


Glucagon further reduced OXA secretion in islets pretreated with diazoxide or an anti-insulin antibody .


Glucagon inhibits OXA secretion in humans and animals , irrespective of changes in glucose or insulin levels .


Through modifying OXA secretion , glucagon may influence energy expenditure , body weight , food intake and glucose metabolism .


This study aimed to determine the interaction between a high-fructose diet and PA levels on postprandial lipidemia and inflammation in normal-weight , recreationally active individuals .


Twenty-two men and women ( age , 21.2 0.6 yr ; body mass index , 22.5 0.6 kg m ( -2 ) ) consumed an additional 75 g of fructose for 14 d on two separate occasions : high physical activity ( PA ) ( approximately 12,500 steps per day ) ( FR + active ) and low PA ( approximately 4500 steps per day ) ( FR + inactive ) .


A fructose-rich test meal was given before and at the end of each intervention .


Blood was sampled at baseline and for 6 h after the meal for triglycerides ( TG ) , VLDL , total cholesterol , glucose , insulin , tumor necrosis factor - , interleukin 6 , and C-reactive protein .


Log-transformed TG area under the curve ( AUC ) significantly increased from before ( 10.1 0.1 mg dL ( -1 ) min for 6 h ) to after ( 10.3 0.08 mg dL ( -1 ) min for 6 h , P = 0.04 ) the FR + inactive intervention , with an 88 % increase in peak TG ( P = 0.009 ) and an 84 % increase in peak VLDL ( P = 0.002 ) .


Peak interleukin 6 also increased by 116 % after the FR + inactive intervention ( P = 0.009 ) .


Insulin total AUC significantly decreased after FR + active intervention ( P = 0.04 ) , with no change in AUC after the FR + inactive intervention .


No changes were observed in glucose , tumor necrosis factor - , and C-reactive protein concentrations ( P > 0.05 ) .


Low PA during a period of high fructose intake augments fructose-induced postprandial lipidemia and inflammation , whereas high PA minimizes these fructose-induced metabolic disturbances .


Even within a young healthy population , maintenance of high PA ( > 12,500 steps per day ) decreases susceptibility to cardiovascular risk factors associated with elevated fructose consumption .


Apnea of prematurity is a common condition that is usually treated with caffeine , an adenosine receptor blocker that has powerful influences on the central nervous system .


However , little is known about the long-term effects of caffeine on sleep in the developing brain .


We hypothesized that neonatal caffeine use resulted in long-term abnormalities in sleep architecture and breathing during sleep .


A total of 201 ex-preterm children aged 5-12 years who participated as neonates in a double-blind , randomized , controlled clinical trial of caffeine versus placebo underwent actigraphy , polysomnography , and parental sleep questionnaires .


Coprimary outcomes were total sleep time on actigraphy and apnea-hypopnea index on polysomnography .


There were no significant differences in primary outcomes between the caffeine group and the placebo ( adjusted mean difference of -6.7 [ 95 % confidence interval ( CI ) = -15.3 to 2.0 min ] ; P = 0.13 for actigraphic total sleep time ; and adjusted rate ratio [ caffeine/placebo ] for apnea-hypopnea index of 0.89 [ 95 % CI = 0.55-1 .43 ] ; P = 0.63 ) .


Polysomnographic total recording time and total sleep time were longer in the caffeine group , but there was no difference in sleep efficiency between groups .


The percentage of children with obstructive sleep apnea ( 8.2 % of caffeine group versus 11.0 % of placebo ; P = 0.22 ) or elevated periodic limb movements of sleep ( 17.5 % in caffeine group versus 11 % in placebo group ) was high , but did not differ significantly between groups .


Therapeutic neonatal caffeine administration has no long-term effects on sleep duration or sleep apnea during childhood .


Ex-preterm infants , regardless of caffeine status , are at risk for obstructive sleep apnea and periodic limb movements in later childhood .


To determine whether increased antioxidant intake in women is associated with shorter time to pregnancy ( TTP ) among a cohort of couples being treated for unexplained infertility .


Secondary data analysis of a randomized controlled trial .


Academic medical center associated with a private infertility center .


Females with unexplained infertility .


None .


The time it took to establish a pregnancy that led to a live birth .


Mean nutrient intake exceeded the estimated average requirement ( EAR ) for vitamins C and E. No differences in mean intake of any of the antioxidants were noted between women who delivered a live-born infant during the study period vs. those who did not .


In multivariable models , intake of - carotene from dietary supplements was associated with shorter TTP among women with body mass index ( BMI ) 25 kg/m ( 2 ) ( hazard ratio [ HR ] 1.29 , 95 % confidence interval [ CI ] 1.09-1 .53 ) and women < 35 y ( HR 1.19 , 95 % CI 1.01-1 .41 ) .


Intake of vitamin C from dietary supplements was associated with shorter TTP among women with BMI < 25 kg/m ( 2 ) ( HR 1.09 , 95 % CI 1.03-1 .15 ) and women < 35 y ( HR 1.10 , 95 % CI 1.02-1 .18 ) .


Intake of vitamin E from dietary supplements among women 35 y also was associated with shorter TTP ( HR 1.07 , 95 % CI 1.01-1 .13 ) .


Shorter TTP was observed among women with BMI < 25 kg/m ( 2 ) with increasing vitamin C , women with BMI 25 kg/m ( 2 ) with increasing - carotene , women < 35 y with increasing - carotene and vitamin C , and women 35 y with increasing vitamin E.


NCT00260091 .


Bivalirudin ( Angiox , The Medicine 's Company , Parsippany , NJ ) , a synthetic direct thrombin inhibitor , when compared with standard antithrombotic therapy ( including unfractionated heparin [ UFH ] alone or plus a glycoprotein IIb/IIIa inhibitor ) determines a significant decrease of major and minor bleeding and similar protection against ischemic events both in elective and in urgent percutaneous coronary intervention ( PCI ) .


There is a lack of prospective clinical trial assessing the safety and the efficacy of bivalirudin compared with UFH alone in the subset of biomarker negative patients at high risk of bleeding undergoing to elective PCI through the femoral approach .


This is a single-center , investigator-driven , randomized , double-blind , controlled trial ( www.clinicaltrial.gov registration : NCT01465503 ) .


Consecutive patients at high bleeding risk ( score 10 according to Nikolsky et al. ) undergoing elective PCI through the femoral approach will be screened for eligibility .


Included patients will be randomized ( ratio 1.1 ) to bivalirudin ( Bivalirudin group ) and UFH ( UFH group ) .


The primary endpoint will be the rate of major bleeding ( REPLACE 2 criteria ) .


We expect a major bleeding rate 5 % in the UFH group versus a 3 % event rate in the Bivalirudin group .


Aiming for a 0.05 alpha and 0.80 power , a total of 662 patients will be needed .


This number will be increased by about 25 % ( leading to a total of 830 patients ) because of uncertainty about expected endpoint rates .


The present trial will give important information on what is the best anticoagulation regimen when performing PCI through the femoral approach in patients at high risk for bleeding .


Sexual and reproductive health ( SRH ) services for HIV-positive women and men often neglect their fertility desires .


We examined factors associated with pregnancy intent among recently diagnosed HIV-positive women ( N = 106 ) and men ( N = 91 ) who reported inconsistent condom use and were enrolled in an SRH intervention conducted in public sector HIV care clinics in Cape Town .