Patients with biopsy-proven IgAN , proteinuria and low serum creatinine were randomly allocated to receive tonsillectomy combined with steroid pulses ( Group A ; n = 33 ) or steroid pulses alone ( Group B ; n = 39 ) .


The primary end points were urinary protein excretion and the disappearance of proteinuria and/or hematuria .


During 12 months from baseline , the percentage decrease in urinary protein excretion was significantly larger in Group A than that in Group B ( P < 0.05 ) .


However , the frequency of the disappearance of proteinuria , hematuria , or both ( clinical remission ) at 12 months was not statistically different between the groups .


Logistic regression analyses revealed the assigned treatment was a significant , independent factor contributing to the disappearance of proteinuria ( odds ratio 2.98 , 95 % CI 1.01-8 .83 , P = 0.049 ) , but did not identify an independent factor in achieving the disappearance of hematuria or clinical remission .


The results indicate tonsillectomy combined with steroid pulse therapy has no beneficial effect over steroid pulses alone to attenuate hematuria and to increase the incidence of clinical remission .


Although the antiproteinuric effect was significantly greater in combined therapy , the difference was marginal , and its impact on the renal functional outcome remains to be clarified .


5-10 % diabetes patients will develop diabetic foot ulceration at some time during the life .


The purpose of this study was to compare the effectiveness of Mepilex Lite dressings and vaseline gauze care in the healing of foot ulcers in diabetic patients .


This was a randomized controlled trial , and a sample of 50 diabetic patients who had developed foot ulcers was assessed .


Comparisons were made regarding parameters related to wound healing , including healing time and wound pain , and also regarding the adverse events .


The results showed that foot ulcers in the study group ( Mepilex Lite , 24 patients ) healed in a median of 49.9 days , which was significantly different from the healing time in the control group ( median , 65.5 days , 26 patients ; P = 0.038 ) .


No statistically significant differences were detected between the 2 groups with pain .


However , Mepilex Lite dressings significantly reduced wound area ( P < 0.05 ) .


The researchers conclude that Mepilex Lite dressing provides a promising alternative to diabetic foot ulcers and is worthy of further research .


To determine the effect of Chinese massage combined with core stability exercises on nonspecific low back pain .


In the prospective study , ninety-two participants with nonspecific low back pain were divided into experimental and control group at random , and 46 in each .


The experimental group were treated using Chinese massage combined with core stability exercises , while the control group were treated using Chinese massage alone .


The two groups were evaluated using visual analog scale and Oswestry disability index at baseline , immediately after two and eight weeks .


In addition , the recurrence rate of nonspecific low back pain was evaluated one year after the last intervention .


Two weeks after treatment , both VAS and ODI scores decreased significantly in two groups ( p < 0.05 ) , when compared with the values before treatment , but no difference between the two groups ( p > 0.05 ) .


Eight weeks later , the VAS and ODI scores decreased significantly in both groups ( p < 0.05 ) ; at the same time , both VAS and ODI scores were significantly lower ( p < 0.05 ) in the experimental group than those in the control group .


At the final follow-up , five cases recurred in the experimental group and nineteen cases in the control group , the control group has a significantly higher recurrence rate ( p < 0.05 ) .


Core stability exercises can improve the therapeutic effect of Chinese massage in treating nonspecific low back pain .


To evaluate the acceptability and efficacy of a psycho-educational intervention designed to improve effective coping and reduce symptom severity in children with cancer .


Cancer treatments increase survival rates and also cause physical and psychological effects on children with cancer .


A psycho-educational intervention is used to assist children and adolescents with these effects and its efficacy has been described in several studies .


A randomized controlled trial .


Participants being treated were recruited and randomly assigned to two groups from September 2011-February 2013 in Taiwan .


The intervention group received a psycho-educational intervention in addition to standard care , while the control group received only standard care .


Each participant was assessed using a paediatric cancer coping scale and perceived symptom severity was evaluated at three time points ( baseline , 1 month and 3 months ) .


A repeated-measures analysis of variance was used to estimate the effects of intervention .


Qualitative findings were analysed using content analysis .


No significant difference in coping scores was found between groups , but the experimental group reported significantly lower scores in gastrointestinal problems and pain .


Most symptoms decreased significantly over time in both groups , except for gastrointestinal problems .


The scores in pain , bone marrow suppression and body image showed significant interaction effects between groups on changes over time .


Qualitative results reported that participants evaluated the intervention positively , especially about receipt of psychological support and learnt coping skills .


The psycho-educational intervention administered was acceptable for children with cancer and was found to reduce gastrointestinal problems and pain .


Renin-angiotensin system inhibitors have renoprotective effects in patients with chronic kidney disease , but most patients treated with these drugs have residual urinary albumin excretion .


Some small clinical studies show that mineralocorticoid receptor blockade reduces albuminuria .


Our study aimed to examine the beneficial effects of addition of a selective aldosterone antagonist , eplerenone , to renin-angiotensin system inhibitors in hypertensive patients with non-diabetic chronic kidney disease .


In this double-blind , randomised , placebo-controlled trial , we enrolled hypertensive patients , aged 2079 years , with albuminuria ( urinary albumin-to-creatinine ratio [ UACR ] in the first morning void urine of 30599 mg/g ) , an estimated glomerular filtration rate of 50 mL/min per 173 m2 or more , and who had received an angiotensin-converting enzyme inhibitor , an angiotensin receptor blocker , or both , for at least 8 weeks .


Participants were from 59 clinics and hospitals in Japan .


Eligible patients were randomly assigned ( 1:1 ) , stratified by baseline characteristics , to either low-dose eplerenone ( 50 mg/day ) or placebo , with continuation of standard antihypertensive treatment to attain therapeutic goals ( < 130/80 mm Hg ) for 52 weeks .


We assessed efficacy in all patients who received allocated treatment , provided a baseline and post-treatment urine sample , and remained in follow-up .


We assessed safety in all patients who received allocated treatment .


The primary efficacy measure was percent change in UACR in the first morning void urine at week 52 from baseline .


The trial is registered at the clinical trials registry of University Hospital Medical Information Network ( UMIN ) , trial identification number UMIN000001803 .


Between April 1 , 2009 , and March 31 , 2012 , we randomly allocated 170 patients to the eplerenone group and 166 patients to the placebo group .


In the primary efficacy analysis , mean percent change in UACR from baseline was 173 % ( 95 % CI 3365 to 094 ) for 158 patients in the eplerenone group compared with 103 % ( 675 to 223 ) for 146 patients in the placebo group ( absolute difference 276 % [ 5115 to 396 ] ; p = 00222 ) .


In the safety analyses , 53 ( 31 % ) of 169 patients in the eplerenone group had adverse events ( five serious ) , as did 49 ( 30 % ) of 163 in the placebo group ( seven serious ) .


Although mean serum potassium concentration was higher in the eplerenone group than the placebo group , severe hyperkalaemia ( > 55 mmol/L ) was not recorded in either group .


Addition of low-dose eplerenone to renin-angiotensin system inhibitors might have renoprotective effects through reduction of albuminuria in hypertensive patients with non-diabetic chronic kidney disease , without serious safety concerns .


Pfizer .


Patients with kidney failure treated with maintenance hemodialysis ( HD ) are poor responders to clopidogrel .


More beneficial platelet-inhibiting strategies in HD patients therefore are required .


Single-center , prospective , randomized , crossover study .


25 HD patients in Seoul , Korea .


Patients were randomly assigned to receive clopidogrel ( 300mg loading , 75mg once daily for maintenance dose ) or ticagrelor ( 180mg loading , 90mg twice daily for maintenance dose ) for 14 days , and after a 14-day washout period , crossover treatment for another 14 days .


All patients received aspirin ( 100mg/d ) .


Platelet function was evaluated predosing and at 1 , 5 , and 48 hours and 14 days after the first loading dose .


During the offset phase , platelet function was assessed at 1 hour and 2 , 4 , and 14 days after the last dose by light transmittance aggregometry and the VerifyNow P2Y12 assay , and patients were genotyped for the CYP2C19 * 2 allele .


Maximal extent of aggregation , inhibition of platelet aggregation ( IPA ) , P2Y12 reaction units ( PRUs ) , and percentage of inhibition were evaluated .


We performed per-protocol analysis , excluding patients who did not complete the protocol .


9 patients did not complete the protocol ( 7 patients due to adverse events ; 2 , nonadherence ) .


Higher IPA occurred with ticagrelor than with clopidogrel at 1 , 5 , and 48 hours and 14 days after loading .


By 5 hours after loading , a greater proportion of patients in the ticagrelor group than in the clopidogrel group achieved IPA > 50 % ( 75 % vs 12 % , respectively ; P < 0.05 ) and IPA > 70 % ( 44 % vs 0 % , respectively ; P < 0.05 ) .


Rates ( slope ) of onset and offset of the antiplatelet effect were faster in patients receiving ticagrelor than for those receiving clopidogrel ( P < 0.05 ) .


Regardless of CYP2C19 * 2 allele , the ticagrelor group had significantly lower PRUs at all times than the clopidogrel group .


Single-center study with a small number of patients , not a double-blind study , and not intention-to-treat analysis .


Ticagrelor may result in more rapid and greater platelet inhibition than clopidogrel in patients with kidney failure receiving HD .


Nowadays , laparoscopic cholecystectomy ( LC ) is undoubtedly considered the `` gold standard '' in the surgical treatment of symptomatic gallstones , gallbladder adenomas and acute cholecystitis .


Among the alternative energy sources proposed ( monopolar , bipolar electric scalpel , radiofrequency sealers ) with the aim to dissect and/or seal , the ultrasonic energy has been frequently adopted , however without a widespread acceptance among surgeons for routine or emergency laparoscopic cholecystectomy .


This study investigates the possible beneficial aspects of ultrasonic dissection and its efficacy in the closure of the cystic artery and duct .


Patients were retrospectively divided into 2 groups according to the instruments used for division of the cystic artery and duct as well as for dissection of the liver bed : 121 patients in whom dissection and coagulation were performed using monopolar coagulation and 43 patients who were all treated with the ultrasonically activated scalpel harmonic ACE ( Ethicon Endo-Surgery ) as the sole instrument used in the whole procedure .


The mean operative time , was significantly shorter in the harmonic group than in the traditional group ( 35.36 + 10.15 min vs. 55.6 +12.10 vs. respectively ; p < 0.0001 ) .


The rate of gallbladder perforation was significantly higher in the traditional group than in the harmonic group 20.66 % ( 25 patients ) vs. 6.98 % ( 3 patients ) , respectively ; p < 0.05 ) .


Intraoperative volume blood loss was significantly more in the traditional group than in the HS group ( 29.32 +14.21 vs. 12.41 +8.22 ; p < 0.0001 ) .


The mean amount of postoperative drainage was not significantly different among the two group ( 18.41 +6.54 vs. 15.96 +8.69 ml , p > 0.05 ) .


No considerable visceral injury has been recorded in either group .


The postoperative parameters observed included postoperative hospital stay and morbidity for each group .


The hospital stay was not significantly shorter in harmonic group ( 48.15 +4.29 vs. 49.06 +2.94 h , p > 0.05 ) .


The overall morbidity rate was 14.02 % ( not significant ) .


The use of the harmonic scalpel shows some statistically significant advantages limited to a few intraoperative parameters .


We conclude that a wider use of harmonic scalpel not offers such advantages to make it the reference technique .


Pulse pressure ( PP ) , might be a stronger determinants of cardiovascular risk .


To investigate the effect of interval training program on PP in subjects with hypertension .


Two hundred and forty five male patients with mild to moderate ( Systolic Blood Pressure [ SBP ] between 140-179 & Diastolic Blood Pressure [ DBP ] between 90-109 mmHg ) essential hypertension were age-matched and grouped into exercise and control groups .


The exercise ( work : rest ratio of 1:1 ) groups involved in an 8-weeks interval training programs of between 45-60 minutes , at intensities of 60-79 % of HR max ( maximum heart rate ) , while the control group remained sedentary during this period .


SBP , DBP , VO2max and PP were assessed .


Findings of the study revealed significant correlation between PP and blood pressure ; correlation of PP with SBP was much stronger ( 95 % variance ) .


Also , there was significant effect of the exercise training program on SBP , DBP and PP .


Changes in VO2max also negatively correlated with changes in PP ( r = -.285 ) at p < 0.05 .


Moderate intensity interval training programs is effective in the non-pharmacological management of hypertension and may prevent cardiovascular event through the down regulation of PP in hypertension .


To evaluate the microleakage of Class II cavities restored with experimental low-shrinking resin composites proposed for bulk filling and to measure their microtensile bond strength ( microTBS ) to dentin and compare to those of previously marketed low-shrinkage composites .


Class II cavities ( 7 mm occluso-gingival height , 2 mm mesio-distal depth of the box , 4 mm occlusal depth , 4 mm bucco-lingual width ) were prepared in 50 molars and randomly divided into five groups ( n = 10 ) , according to the material : SureFil SDR flow ( SDR ) , Filtek Silorane ( FS ) and experimental materials ( G-aenial Flo bulk fill , GF ; G-aenial Universal Flo bulk fill , GUF ; GC Kalore bulk fill , GK ) .


Microleakage was separately assessed at enamel and dentin margins by scoring the depth of silver-nitrate penetration .


Twenty teeth divided into five groups ( n = 4 ) were selected for microTBS testing .


The same materials as for microleakage assessment were placed in bulk to mid-coronal dentin .


Microtensile beams were loaded in tension , and microTBS at failure was calculated in MPa .


Microleakage and microTBS data were analyzed by ANOVA on ranks , followed Dunn 's post hoc test ( P < 0.05 ) .


Microleakage was not observed at the enamel interface in any of the groups .


At the dentin interface , SDR recorded significantly higher microleakage than the other materials .


microTBS of GF , GUF and GK did not differ among each other ( 33 + / - 12 MPa , 31 + / - 11 MPa , 30 + / - 9 MPa , respectively ) , while SDR ( 63 + / - 17 MPa ) and FS ( 55 + / - 17MPa ) achieved significantly higher microTBS values .


No direct association between the sealing properties and the bond strength values was observed .


Failure of fusion after a transforaminal lumbar interbody fusion ( TLIF ) procedure is a challenging problem that can lead to ongoing low-back pain , dependence on pain medication , and inability to return to work .


B2A is a synthetic peptide that has proven efficacy in achieving fusion in animal models and may have a better safety profile than bone morphogenetic protein .


The authors undertook this study to evaluate the safety and efficacy of B2A peptide-enhanced ceramic granules ( Prefix ) in comparison with autogenous iliac crest bone graft ( ICBG , control ) in patients undergoing single-level TLIF .


Twenty-four patients with single-level degenerative disorders of the lumbar spine at L2-S1 requiring TLIF were enrolled between 2009 and 2010 .


They were randomly assigned to 3 groups : a control group ( treated with ICBG , n = 9 ) , a Prefix 150 group ( treated with Prefix 150 g/cm ( 3 ) granules , n = 8 ) , and a Prefix 750 group ( treated with Prefix 750 g/cm ( 3 ) granules , n = 7 ) .


Outcome measures included the Oswestry Disability Index ( ODI ) , visual analog pain scale , and radiographic fusion as assessed by CT and dynamic flexion/extension lumbar plain radiographs .


At 12 months after surgery , the radiographic fusion rate was 100 % in the Prefix 750 group , 78 % in the control group , and 50 % in the Prefix 150 group , although the difference was not statistically significant ( p = 0.08 ) .


At 6 weeks the mean ODI score was 41.0 for the control group , 27.7 for the Prefix 750 group , and 32.2 for the Prefix 150 group , whereas at 12 months the mean ODI was 24.4 for control , 31.1 for Prefix 750 , and 29.7 for Prefix 150 groups .


Complications were evenly distributed among the groups .


Prefix appears to provide a safe alternative to autogenous ICBG .


Prefix 750 appears to show superior radiographic fusion when compared with autograft at 12 months after TLIF , although no statistically significant difference was demonstrated in this small study .


Prefix and control groups both appeared to demonstrate comparable improvements to ODI at 12 months .


Interventional Management of Stroke ( IMS ) III is a randomized , parallel arm trial comparing the approach of intravenous tissue-type plasminogen activator followed by endovascular treatment with intravenous tissue-type plasminogen activator alone in patients with acute ischemic stroke presenting < 3 hours of symptom onset .


The trial intended to enroll 900 subjects to ensure adequate statistical power to detect an absolute 10 % difference in the percentage of subjects with good outcome , defined as modified Rankin Scale score of 0 to 2 at 3 months .


In April 2012 , after 656 subjects were randomized , further enrollment was terminated by the National Institute of Neurological Disorders and Stroke based on the prespecified criterion for futility using conditional power < 20 % .


Conditional power was defined as the likelihood of finding statistical significance at the end of the study , given the accumulated data to date and with the assumption that a minimum hypothesized difference of 10 % truly exists between the 2 groups .


The evolution of study data leading to futility determination is described , including the interaction between the unblinded study statisticians and the Data and Safety Monitoring Board in the complex deliberation of analysis results .


The futility boundary was crossed at the trial 's fourth interim analysis .


At this point , based on the conditional power criteria , the Data and Safety Monitoring Board recommended termination of the trial .


Even in spite of prespecified interim analysis boundaries , interim looks at data pose challenges in interpretation and decision making , underscoring the importance of objective stopping criteria .


http://www.clinicaltrials.gov .


Unique identifier : NCT00359424 .


To develop and validate a scoring system for evaluation of long term anorectal dysfunction following radiotherapy for prostate cancer .


Patients treated for prostate cancer with radiotherapy filled in questionnaires on anorectal function and quality of life .


Items for the condensed anorectal dysfunction score ( RT-ARD ) were identified and weighted by binomial regression analysis .


The score was tested in a separate patient material by receiver operating characteristic ( ROC ) analysis and correlations to quality of life domains .


A total of 309 patients participated in the study .


The items selected were `` incontinence for solid stool '' , `` ability to defer defecation '' , `` unproductive call to stool '' , `` clustering of stool '' , and `` mucus in stool . ''


Patients were grouped into three categories according to the RT-ARD score ; 0-8 ( no RT-ARD ) , 9-23 ( minor RT-ARD ) , 24-45 ( major RT-ARD ) .


ROC analyses revealed high sensitivity ( 91 % ) and specificity ( 85 % ) for major RT-ARD .


The prediction model demonstrated a perfect fit in 60 % , moderate fit in 36 % and no fit in 4 % .


There was good correlation between the RT-ARD score and quality of life .


The RT-ARD score is a validated and simple instrument for evaluation of anorectal dysfunction following radiotherapy for prostate cancer , and the RT-ARD score correlates to the patient 's quality of life .


The evaluation of cardiac contraction could benefit from a connection with the underlying helical structure of cardiac fibers in athletes either completely healthy or with minor common cardiopathies like Bicuspid Aortic Valve ( BAV ) .


This study aims to exploit the potential role of 3D strain to improve the physiological understanding of LV function and modification due to physical activity as a comparative model .


Three age-matched groups of young ( age 20.35.4 ) individuals are prospectively enrolled : 15 normal healthy subjects , 15 healthy athletes , and 20 athletes with bicuspid aortic valve ( BAV ) .


All subjects underwent echocardiographic examination and both 2D and 3D strain analysis .


All echo parameters were within the normal range in the three groups .


Global values of end-systolic longitudinal and circumferential strain , assesses by either 2D or 3D analysis , were not significantly different .


The 3D strain analysis was extended in terms of principal and secondary strain ( PS , SS ) .


Global PS was very similar , global SS was significantly higher in athletes and displays a modified time course .


The comparative analysis of strain-lines pattern suggests that the enhancement of LV function is achieved by a more synchronous recruitment of both left - and right-handed helical fibers .


3D strain analysis allows a deeper physiological understanding of LV contraction in different types of athletes .


Secondary strain , only available in 3D , identifies increase of performances due to physical activity ; this appears to follow from the synergic activation of endocardial and epicardial fibers .


To evaluate the effect on acne vulgaris of pricking-bloodletting cupping at Dazhui ( GV 14 ) under acupuncture anesthesia , and establish whether providing anesthesia to the treatment area by manipulating Hegu ( LI 4 ) and Quchi ( LI 11 ) might have an additional therapeutic benefit .


Thirty-eight patients were recruited and randomized into a control group and an intervention group with a single-blind ( observer-blind ) method .


The control group was treated by pricking-bloodletting cupping at Dazhui ( GV 14 ) - and the studied group by pricking-bloodletting cupping at Dazhui ( GV 14 ) under acupuncture anesthesia at Hegu ( LI 4 ) and Quchi ( LI 11 ) .


Both groups were treated twice weekly for 6 weeks .


The analgesic and therapeutic effects of acupuncture were evaluated on a visual analog scale ( VAS ) and global acne grading system ( GAGS ) , respectively .


There were differences in the VAS scores of pain on pricking and in the pricked area , and the duration of pain between the groups .


After 12 treatments , there was a significant reduction in GAGS scores from baseline in both groups , but there was no significant difference between the groups .


Acupuncture anesthesia at Hegu ( LI 4 ) and Quchi ( LI 11 ) is an effective means of alleviating the pain of pricking-bloodletting cupping and reducing the duration of pain in the treatment area .


Pricking-bloodletting cupping at Dazhui ( GV 14 ) improves the skin lesions of patients with moderate acne vulgaris , but acupuncture anesthesia does not appear to have an additional therapeutic effect .


Screening of immunization status at each health care encounter is recommended to improve immunization coverage rates but is often limited to primary care practices .


A pilot intervention study was performed to ascertain the immunization status of hospitalized children and determine if development of an immunization plan before discharge would improve the vaccination status for such children .


On the basis of power calculations estimated to detect an increase in immunization status from 60 % to 70 % with 80 % power , 356 randomly selected children were enrolled between March 6 , 2012 and June 14 , 2012 .


Immunization records were obtained , immunization status determined , and parent/guardian informed if catch-up dose ( s ) were needed .


If parent requested vaccine dose ( s ) , they were administered before discharge .


Vaccination status was current per Advisory Committee on Immunization Practices guidelines in 73 % of hospitalized children , and 27 % children required catch-up dose ( s ) ( 200 doses for 95 children ) .


Human papilloma virus vaccine ( dose 1 ) , varicella zoster vaccine ( dose 2 ) , and meningococcal conjugate vaccine were the most commonly identified dose ( s ) needed .


Of those requiring catch-up dose ( s ) , 25 % were caught up , increasing vaccination status to 80 % at 1-month post hospital discharge .


This is the first study to determine the immunization status of hospitalized pediatric patients of all ages , including adolescents , providing new data on the immunization status of the inpatient pediatric population .


A pilot intervention consisting of obtaining immunization records , determining immunization status , and discussing catch-up dose ( s ) before discharge resulted in improvement of immunization status , suggesting that the inpatient setting may be used along with many other national strategies to help address missed vaccination opportunities .


The objective of our study was to conduct a randomized controlled trial of educational interventions that were created to improve performance of screening mammography interpretation .


We randomly assigned physicians who interpret mammography to one of three groups : self-paced DVD , live expert-led educational seminar , or control .


The DVD and seminar interventions used mammography cases of varying difficulty and provided associated teaching points .


Interpretive performance was compared using a pretest-posttest design .


Sensitivity , specificity , and positive predictive value ( PPV ) were calculated relative to two outcomes : cancer status and consensus of three experts about recall .


The performance measures for each group were compared using logistic regression adjusting for pretest performance .


One hundred two radiologists completed all aspects of the trial .


After adjustment for preintervention performance , the odds of improved sensitivity for correctly identifying a lesion relative to expert recall were 1.34 times higher for DVD participants than for control subjects ( 95 % CI , 1.00-1 .81 ; p = 0.050 ) .


The odds of an improved PPV for correctly identifying a lesion relative to both expert recall ( odds ratio [ OR ] = 1.94 ; 95 % CI , 1.24-3 .05 ; p = 0.004 ) and cancer status ( OR = 1.81 ; 95 % CI , 1.01-3 .23 ; p = 0.045 ) were significantly improved for DVD participants compared with control subjects , with no significant change in specificity .


For the seminar group , specificity was significantly lower than the control group ( OR relative to expert recall = 0.80 ; 95 % CI , 0.64-1 .00 ; p = 0.048 ; OR relative to cancer status = 0.79 ; 95 % CI , 0.65-0 .95 ; p = 0.015 ) .


In this randomized controlled trial , the DVD educational intervention resulted in a significant improvement in screening mammography interpretive performance on a test set , which could translate into improved interpretative performance in clinical practice .


Pelubiprofen is a prodrug of 2-arylpropionic acid with relatively selective effects on cyclooxygenase-2 activity .


The aim of this study was to compare the efficacy and safety profiles of pelubiprofen with those of celecoxib in patients with rheumatoid arthritis .


This was a 6-week , multicenter , randomized , double-blind , double-dummy , parallel-group , phase III , non-inferiority clinical trial .


The primary end point was non-inferiority of pain decrease from baseline to week-6 as determined using a 100 mm pain visual analog scale ( VAS ) .


Pelubiprofen was considered non-inferior to celecoxib if the lower limit of the 97.5 % confidence interval for treatment difference [ ( pain reduction in pelubiprofen group ) - ( pain reduction in celecoxib group ) ] was more than -10 mm .


The secondary end points were as follows : non-inferiority of ( 1 ) reduction of Korean health assessment questionnaire ( KHAQ ) score ; ( 2 ) decreased duration of morning stiffness ; and ( 3 ) decrease in the frequency and total dose of rescue drugs after 6 weeks of treatment .


Seventy-seven patients in the pelubiprofen group and 68 patients in the celecoxib group started the study medication .


Pelubiprofen was non-inferior to celecoxib with regard to reduction in VAS pain severity ( difference , mean SD 5.0 20.1 ; 97.5 % CI , -2.3 to ) .


Pelubiprofen was also non-inferior to celecoxib in terms of the secondary end points , such as , decrease in KHAQ score ( 0.0 0.5 , 97.5 % CI -0.2 to ) , decrease in duration of morning stiffness ( median 0.0 minute in both groups ) , and decrease in the frequency ( 0.7 3.5 , 97.5 % CI -0.6 to ) and total amount ( 0.7 3.6 , 97.5 % CI -0.6 to ) of rescue medication uses during the 6 week study period .


Safety analysis revealed 31.2 % patients in the pelubiprofen group and 20.6 % patients in the celecoxib group experienced an adverse drug reaction ( ADR ) .


The frequency of gastrointestinal ADRs was 20.8 % and 8.8 % , respectively .


Pelubiprofen was found to be as effective as celecoxib at pain reduction and for relieving stiffness in RA patients .


However , more patients in the pelubiprofen group experienced ADR and the frequency of gastrointestinal ADRs was higher in the pelubiprofen group .


ClinialTrials.gov identifier : NCT01781702 .


Topical corticosteroids ( TC ) consistently show effectiveness against itch , a paradigmatic symptom , in various eczemas .


Rapid itch relief is a therapeutic goal .


The early response of itch to TC has not been adequately studied .


To assess the effect on itch of a TC , methylprednisolone aceponate 0.1 % ointment ( MPA ) , in induced eczema in volunteers sensitized to nickel sulphate .


Sixteen volunteers with a late positive patch-test reaction to nickel sulphate entered the study .


Eczema was treated once daily with fingertip unit of MPA for 5days .


Pruritus intensity was assessed with a 10cm visual analogue scale ( VAS ) .


Mean time to itch relief ( TR ) defined as the time to reach a 30 % decrease in the highest VAS value recorded was assessed , as well as TR-baseline , colorimetry and planimetric morphometry of the reaction .


Mean TR was 1.0 days [ standard deviation ( SD ) = 1.1 ] and mean TR - baseline was 1.6 days ( SD = 1.4 ) .


Five volunteers reached 100 % decrease from itch baseline-VAS in 2.01.2 days , whereas a 75 % decrease was obtained in 1.71.6 days by 16 volunteers .


A clinical improvement of patch-test reaction was apparent at day 11 , although erythema was still present .


We present a valid model to assess the efficacy and speed of action of TC treatment to alleviate pruritus and the signs of eczema .


The fast effect of MPA against pruritus supports the appropriateness of treating allergic contact eczema with TC .


To assess whether urea-based cream ( UBC ) has prophylactic benefits on sorafenib-induced hand-foot skin reaction ( HFSR ) in patients with advanced hepatocellular carcinoma ( HCC ) .


In this randomized , open-label trial , 871 patients with advanced HCC throughout China were treated with 10 % UBC three times per day plus best supportive care ( BSC ; n = 439 ) or BSC alone excluding all creams ( n = 432 ) , starting on day 1 of sorafenib treatment , for up to 12 weeks .


HFSR was assessed every 2 weeks and at 14 weeks for patients completing the study .


Once HFSR occurred , patients were allowed any cream , including a UBC .


The 12-week incidence of any grade HFSR was significantly lower in the UBC group versus the BSC-alone group ( 56.0 % v 73.6 % , respectively ; odds ratio [ OR ] , 0.457 ; 95 % CI , 0.344 to 0.608 ; P < .001 ) , as was the incidence of grade 2 HFSR ( 20.7 % v 29.2 % , respectively ; OR , 0.635 ; 95 % CI , 0.466 to 0.866 ; P = .004 ) .


Median time to first occurrence of HFSR was significantly longer in the UBC group than the BSC-alone group ( 84 v 34 days , respectively ; hazard ratio , 0.658 ; 95 % CI , 0.541 to 0.799 ; P < .001 ) .


Elevated AST was associated with increased risk of HFSR but did not alter the treatment effect of UBC .


UBC plus BSC , compared with BSC alone , did not affect the sorafenib dose reduction or interruption rate ( 9.1 % v 11.8 % , respectively ; P = .1937 ) , response rate ( 11.1 % v 10.1 % , respectively ; P = .6674 ) , or disease control rate ( 98.8 % v 98.2 % , respectively ; P = .5350 ) at week 12 .


UBC prophylaxis in patients with advanced HCC starting sorafenib reduced HFSR rates , extended the time to first occurrence of HFSR , and improved patient quality of life compared with BSC .


Blinded , randomized , placebo-controlled trials to determine the role of UBC on the incidence and severity of HFSR are warranted .


Epidemiological studies have found that a diet high in fibre and coffee , but low in red meat , reduces the risk for type 2 diabetes .


We tested the hypothesis that these nutritional modifications differentially improve whole-body insulin sensitivity ( primary outcome ) and secretion .


Inclusion criteria were : age 18-69 years , BMI 30 kg/m ( 2 ) , type 2 diabetes treated with diet , metformin or acarbose and known disease duration of 5 years .


Exclusion criteria were : HbA1c > 75 mmol/mol ( 9.0 % ) , type 1 or secondary diabetes types and acute or chronic diseases including cancer .


Patients taking any medication affecting the immune system or insulin sensitivity , other than metformin , were also excluded .


Of 59 patients ( randomised using randomisation blocks [ four or six patients ] with consecutive numbers ) , 37 ( 54 % female ) obese type 2 diabetic patients completed this controlled parallel-group 8-week low-energy dietary intervention .


The participants consumed either a diet high in cereal fibre ( whole grain wheat/rye : 30-50 g/day ) and coffee ( 5 cups/day ) , and free of red meat ( L-RISK , n = 17 ) or a diet low in fibre ( 10 g/day ) , coffee-free and high in red meat ( 150 g/day ) diet ( H-RISK , n = 20 ) .


Insulin sensitivity and secretion were assessed by hyperinsulinaemic-euglycaemic clamp and intravenous glucose tolerance tests with isotope dilution .


Whole-body and organ fat contents were measured by magnetic resonance imaging and spectroscopy .


Whole-body insulin sensitivity increased in both groups ( mean [ 95 % CI ] ) ( H-RISK vs L-RISK : 0.8 [ 0.2 , 1.4 ] vs 1.0 [ 0.4 , 1.7 ] mg kg ( -1 ) min ( -1 ) , p = 0.59 ) , while body weight decreased ( -4.8 % [ -6.1 % , -3.5 % ] vs -4.6 % [ -6.0 % , -3.3 % ] , respectively ) .


Hepatic insulin sensitivity remained unchanged , whereas hepatocellular lipid content fell in both groups ( -7.0 % [ -9.6 % , -4.5 % ] vs -6.7 % [ -9.5 % , -3.9 % ] ) .


Subcutaneous fat mass ( -1,553 [ -2,767 , -340 ] cm ( 3 ) vs -751 [ -2,047 ; 546 ] cm ( 3 ) , respectively ) visceral fat mass ( -206 [ -783 , 371 ] cm ( 3 ) vs -241 [ -856 , 373 ] cm ( 3 ) , respectively ) and muscle fat content ( -0.09 % [ -0.16 % , -0.02 % ] vs -0.02 % [ -0.10 % , 0.05 % ] , respectively ) decreased similarly .


Insulin secretion remained unchanged , while the proinflammatory marker IL-18 decreased only after the L-RISK diet .


No evidence of a difference between both low-energy diets was identified .


Thus , energy restriction per se seems to be key for improving insulin action in phases of active weight loss in obese type 2 diabetic patients , with a potential improvement of subclinical inflammation with the L-RISK diet .


Clinicaltrials.gov NCT01409330 .


This study was supported by the Ministry of Science and Research of the State of North Rhine-Westphalia ( MIWF NRW ) , the German Federal Ministry of Health ( BMG ) , the Federal Ministry for Research ( BMBF ) to the Center for Diabetes Research ( DZD e.V. ) and the Helmholtz Alliance Imaging and Curing Environmental Metabolic Diseases ( ICEMED ) .


Safety of tenofovir disoproxil fumarate/emtricitabine ( TDF-FTC ) has been studied more extensively among HIV-infected patients than among HIV-uninfected people .


Using data from a pre-exposure trial - FEM-PrEP - , we determined the cumulative probabilities of grade 1 + ALT , AST and creatinine and grade 2 + phosphorus toxicities ; ALT/AST toxicities by baseline hepatitis B status ; and change in mean creatinine , phosphorus , ALT and AST levels controlling for TDF-FTC adherence .


FEM-PrEP was a randomized , blinded , placebo-controlled trial of daily TDF-FTC among women in Africa .


Enrolled women were in general good health , HIV antibody negative , 18 to 35 years old , hepatitis B surface antigen negative , and had normal hepatic and renal function at baseline .


AST , ALT , phosphorus and serum creatinine were measured regularly throughout the trial .


TDF-FTC concentrations were measured to assess adherence to TDF-FTC .


The cumulative probabilities of grade 1 + creatininemia and grade 2 + phosphatemia toxicities were not statistically different between TDF-FTC and placebo arms .


The cumulative probabilities of grade 1 + ALT and AST toxicities were higher among participants in the TDF-FTC arm than in the placebo arm ( p = 0.03 for both ) .


The proportions of grade 1 + and grade 2 + ALT or AST toxicities were significantly higher in participants who were hepatitis B virus surface antibody ( HBsAb ) positive than in those who were HBsAb-negative .


Women with good adherence had higher mean change from baseline to week 4 in their AST levels ( 2.90 ( 0.37 , 5.42 ) ; p = 0.025 ) than women with less than good adherence .


We did not observe a significant relationship between randomization to TDF-FTC and creatinine or phosphorus toxicities .


Women randomized to TDF-FTC had higher rates of mild to moderate ALT/AST toxicities , especially women with prior hepatitis B virus exposure .


We also observed a significant increase in AST from baseline to week 4 among women who had higher adherence to TDF-FTC during that interval .


#NCT 00625404 , February 19 , 2008 .


This study implemented pharmacokinetic/pharmacodynamic modelling to support the clinical development of RBP-6000 , a new , long-acting , sustained-release formulation of buprenorphine for the treatment of opioid dependence .


Such a formulation could offer advantages over existing buprenorphine pharmacotherapy by improving patient compliance and reducing the diversion of the product .


A population pharmacokinetic model was developed using 36 opioid-dependent subjects who received single subcutaneous doses of RBP-6000 .


Another pharmacokinetic/pharmacodynamic model was developed using - opioid receptor occupancy ( ORO ) data to predict efficacy of RBP-6000 after repeated doses .


It was also assessed how buprenorphine plasma concentrations were correlated with opioid withdrawal symptoms and hydromorphone agonist blockade data from 15 heroin-dependent subjects .


The resulting pharmacokinetic model accurately described buprenorphine and norbuprenorphine plasma concentrations .


A saturable maximum effect ( E max ) model with 0.67 ng/mL effective concentration at 50 % of maximum ( EC50 ) and 91 % E max best described ORO versus buprenorphine plasma concentrations .


Linear relationships were found among ORO , withdrawal symptoms and blockade of agonist effects .


Previously published findings have demonstrated ORO 70 % is needed to achieve withdrawal suppression and blockade of opioid agonist subjective effects .


Model simulations indicated that a 200 mg RBP-6000 dose should achieve 23 ng/mL buprenorphine average concentrations and desired efficacy .


The aim of this study was to investigate the effects of the vasodilating - blocker nebivolol and the cardioselective - blocker metoprolol on nitric oxide ( NO ) levels at vascular graft endothelium and vasa vasorum compared to controls in patients undergoing coronary artery bypass graft surgery .


This was a prospective study .


Fifty-five patients were divided into three groups : nebivolol group ( group N , n = 23 ) , metoprolol group ( group M , n = 16 ) , and control group ( group A , n = 16 ) .


Group N received nebivolol 5 mg once daily , and group M received metoprolol 50 mg once daily for 15 days in the preoperative period .


Control patients did not use - blocker therapy .


Tissue samples of both left internal mammary artery ( LIMA ) and saphenous vein grafts were investigated for NO activity using immunohistochemical methods .


Demographic characteristics and risk factors were similar between groups .


We observed the highest NO activity in group N in both endothelial and vasa vasorum samples of LIMA and saphenous veins .


NO activity of metoprolol group was similar to controls .


According to our results , we think that nebivolol may be safer and preferable in order to diminish graft spasm in patients undergoing coronary artery bypass graft surgery due to the NO-mediated vasodilating effect .


To evaluate the effectiveness of subcostal TAP block and to compare its efficacy with that of posterior TAP block in decreasing postoperative pain in patients undergoing laparoscopic cholecystectomy during general anesthesia .


Prospective , randomized , double-blind study .


Academic medical center .


60 adult , ASA physical status 1 and 2 patients of both genders , aged 18-60 years , scheduled for elective laparoscopic cholecystectomy .


Patients were randomized to three groups of 20 patients each .


Group 1 patients received standard general anesthesia ( control group ) ; Group 2 patients received an ultrasound-guided posterior TAP block using 15 mL of 0.375 % ropivacaine on each side ; and Group 3 patients underwent a subcostal TAP block with 15 mL of 0.375 % ropivacaine on each side .


The presence and severity of pain during rest and movement , as well as nausea or vomiting and sedation , were assessed in all patients postoperatively on PACU admission , then at 2 , 4 , 6 , 8 , 12 , and 24-hour intervals .


Patients with a visual analog score ( VAS ) greater than 4 , or those requesting analgesic were given intravenous tramadol 2 mg/kg as an initial dose ; subsequent 1 mg/kg doses of tramadol , if needed , were given .


Patients who received a subcostal TAP block had significantly lower pain scores at rest and on movement than the control group at all times postoperatively .


Although , in the initial postoperative measurement times , the subcostal and posterior TAP groups had comparable pain scores , after 4 hours these scores were significantly lower in patients who had received the subcostal TAP block .


For incisions mainly involving the supra-umbilical region , subcostal TAP block may be a better alternative than the posterior approach for providing postoperative analgesia .


To evaluate pharmacokinetics , recovery times , and recovery quality in horses anesthetized with 1.2 times the minimum alveolar concentration of sevoflurane or desflurane .


6 healthy adult horses .


Anesthesia was maintained with sevoflurane or desflurane for 2 hours at 1.2 times the minimum alveolar concentration .


Horses recovered without assistance .


During recovery , end-tidal gas samples were collected until horses spontaneously moved .


Anesthetic concentrations were measured by use of gas chromatography .


After a 1-week washout period , horses were anesthetized with the other inhalation agent .


Video recordings of anesthetic recovery were evaluated for recovery quality on the basis of a visual analogue scale by investigators who were unaware of the anesthetic administered .


Anesthetic washout curves were fit to a 2-compartment kinetic model with multivariate nonlinear regression .


Normally distributed interval data were analyzed by means of paired Student t tests ; ordinal or nonnormally distributed data were analyzed by means of Wilcoxon signed rank tests .


Horses recovered from both anesthetics without major injuries .


Results for subjective recovery evaluations did not differ between anesthetics .


Area under the elimination curve was significantly smaller and time to standing recovery was significantly less for desflurane than for sevoflurane , although distribution and elimination constants did not differ significantly between anesthetics .


Differences in area under elimination the curve between anesthetics indicated more rapid clearance for desflurane than for sevoflurane in horses , as predicted by anesthetic blood solubility differences in this species .


More rapid elimination kinetics was associated with faster recovery times , but no association with improved subjective recovery quality was detected .


CLP is an orally administered , non-absorbed , superabsorbent polymer being developed to increase fecal excretion of sodium , potassium and water in patients with heart failure and end-stage renal disease .


This study was conducted to evaluate the safety of CLP , and to explore dose-related effects on fecal weight , fecal and urine sodium and potassium excretion , and serum electrolyte concentrations .


This Phase 1 , open-label , dose-escalation study included 25 healthy volunteers , who were administered CLP orally immediately prior to four daily meals for 9 days at doses of 7.5 , 15.0 , and 25.0 g/day ( n = 5/group ) .


An additional dose group received 15.0 g/day CLP under fasting conditions , and an untreated cohort ( n = 5 ) served as control .


Twenty-four-hour fecal and urinary output was collected daily .


Samples were weighed , and sodium , potassium , and other ion content in stool and urine were measured for each treatment group .


Effects on serum cation concentrations , other standard laboratory values , and adverse events were also determined .


At doses below 25.0 g/day , CLP was well tolerated , with a low frequency of self-limiting gastrointestinal adverse events .


CLP increased fecal weight and fecal sodium and potassium content in a dose-related manner .


Concomitant dose-related decreases in urinary sodium and potassium were observed .


All serum ion concentrations remained within normal limits .


In this study , oral CLP removed water , sodium and potassium from the body via the gastrointestinal tract in a dose related fashion .


CLP could become useful for patients with fluid overload and compromised kidney function in conditions such as congestive heart failure , salt sensitive hypertension , chronic kidney disease and end stage renal disease .


NCT01944007 .


Metacognitive training ( MCT ) for patients with psychosis is a psychological group intervention that aims to educate patients about common cognitive biases underlying delusion formation and maintenance , and to highlight their negative consequences in daily functioning .


In this randomized controlled trial , 154 schizophrenia spectrum patients with delusions were randomly assigned to either MCT + treatment as usual ( TAU ) or TAU alone .


Both groups were assessed at baseline , and again after 8 and 24 weeks .


The trial was completed fully by 111 patients .


Efficacy was measured with the Psychotic Symptom Rating Scales ( PSYRATS ) Delusions Rating Scale ( DRS ) , and with specific secondary measures referring to persecutory ideas and ideas of social reference ( the Green Paranoid Thoughts Scale , GPTS ) , cognitive insight ( the Beck Cognitive Insight Scale , BCIS ) , subjective experiences of cognitive biases ( the Davos Assessment of Cognitive Biases Scale , DACOBS ) and metacognitive beliefs ( the 30-item Metacognitions Questionnaire , MCQ-30 ) .


Economic analysis focused on the balance between societal costs and health outcomes ( quality-adjusted life years , QALYs ) .


Both conditions showed a decrease of delusions .


MCT was not more efficacious in terms of reducing delusions , nor did it change subjective paranoid thinking and ideas of social reference , cognitive insight or subjective experience of cognitive biases and metacognitive beliefs .


The results of the economic analysis were not in favour of MCT+TAU .


In the present study , MCT did not affect delusion scores and self-reported cognitive insight , or subjective experience of cognitive biases and metacognitive beliefs .


MCT was not cost-effective .


To investigate the applicability of flowable composites as post luting agents by assessing the push-out strength of posts .


36 intact single rooted human premolars were selected .


The endodontic treatment was performed and half of the specimens were restored with light transmitting posts ( DT Light Post Illusion ) and the other half with opaque posts ( Tech 21 X-OP ) .


In both groups the following combinations of adhesive/cement were tested : OptiBond Solo Plus/Nexus Third Generation ( NX3 ) , XP Bond/SureFil SDR Flow ( SDR ) , and Vertise Flow ( VF ) .


Push-out test was used to assess the retentive strength of fiber posts , which was expressed in megapascals ( MPa ) .


Specimens were analyzed under a stereomicroscope to determine failure mode ( adhesive between luting agent and post , adhesive between luting agent and dentin or mixed failure ) .


Push-out data and failure mode distribution were analyzed by two-way ANOVA and Chi-square test , respectively ( P < 0.05 ) .


The statistical analysis revealed that only the type of luting material significantly influenced push-out bond strength of the post ( P < 0.001 ) .


SDR ( 9.00 + / - 2.17 MPa ) performed similarly to the control group NX3 ( 7.15 + / - 1.74 MPa ) , while VF ( 4.81 + / - 1.51 MPa ) should significantly lower bond strength .


Failure modes differed significantly among groups .


Estrogen therapy is the gold standard treatment for hot flashes and night sweats , but some women are unable or unwilling to use it because of associated risks .


The serotonin-norepinephrine reuptake inhibitor venlafaxine hydrochloride is used widely as a nonhormonal treatment .


While the clinical impression is that serotonin-norepinephrine reuptake inhibitors are less effective than estrogen , these medications have not been simultaneously evaluated in one clinical trial to date .


To determine the efficacy and tolerability of low-dose oral 17-estradiol and low-dose venlafaxine extended release in alleviating vasomotor symptoms ( VMS ) .


In total , 339 perimenopausal and postmenopausal women with at least 2 bothersome VMS per day ( mean , 8.1 per day ) were recruited from the community to MsFLASH ( Menopause Strategies : Finding Lasting Answers for Symptoms and Health ) clinical network sites between December 5 , 2011 , and October 15 , 2012 .


Participants were randomized to double-blind treatment with low-dose oral 17-estradiol ( 0.5 mg/d ) ( n = 97 ) , low-dose venlafaxine hydrochloride extended release ( 75 mg/d ) ( n = 96 ) , or placebo ( n = 146 ) for 8 weeks .


The primary outcome was the mean daily frequency of VMS after 8 weeks of treatment .


Secondary outcomes were VMS severity , bother , and interference with daily life .


Intent-to-treat analyses compared the change in VMS frequency between each active intervention and placebo and between the 2 active treatments .


Compared with baseline , the mean VMS frequency at week 8 decreased to 3.9 ( 95 % CI , 2.9-4 .9 ) VMS per day ( 52.9 % reduction ) in the estradiol group , to 4.4 ( 95 % CI , 3.5-5 .3 ) VMS per day ( 47.6 % reduction ) in the venlafaxine group , and to 5.5 ( 95 % CI , 4.7-6 .3 ) VMS per day ( 28.6 % reduction ) in the placebo group .


Estradiol reduced the frequency of symptoms by 2.3 more per day than placebo ( P < .001 ) , and venlafaxine reduced the frequency of symptoms by 1.8 more per day than placebo ( P = .005 ) .


The results were consistent for VMS severity , bother , and interference .


Low-dose estradiol reduced the frequency of symptoms by 0.6 more per day than venlafaxine ( P = .09 ) .


Treatment satisfaction was highest ( 70.3 % ) for estradiol ( P < .001 vs placebo ) , lowest ( 38.4 % ) for placebo , and intermediate ( 51.1 % ) for venlafaxine ( P = .06 vs placebo ) .


Both interventions were well tolerated .


Low-dose oral estradiol and venlafaxine are effective treatments for VMS in women during midlife .


While the efficacy of low-dose estradiol may be slightly superior to that of venlafaxine , the difference is small and of uncertain clinical relevance .


clinicaltrials.gov Identifier : NCT01418209 .


Alternative forms of cardiac resynchronization therapy ( CRT ) , including biventricular endocardial ( BV-Endo ) and multisite epicardial pacing ( MSP ) , have been developed to improve response .


It is unclear which form of stimulation is optimal .


We aimed to compare the acute haemodynamic response ( AHR ) and electrophysiological effects of BV-Endo with MSP via two separate coronary sinus ( CS ) leads or a single-quadripolar CS lead .


Fifteen patients with a previously implanted CRT system received a second temporary CS lead and left ventricular ( LV ) endocardial catheter .


A pressure wire and non-contact mapping array were placed into the LV cavity to measure LVdP/dtmax and perform electroanatomical mapping .


Conventional CRT , BV-Endo , and MSP were then performed ( MSP-1 via two epicardial leads and MSP-2 via a single-quadripolar lead ) .


The best overall AHR was found using BV-Endo pacing with a 19.6 13.6 % increase in AHR at the optimal endocardial site over baseline ( P < 0.001 ) .


There was an increase in LVdP/dtmax with MSP-1 and MSP-2 compared with conventional CRT , but this was not statistically significant .


Biventricular endocardial pacing from the optimal site was significantly superior to conventional CRT ( P = 0.039 ) .


The AHR achieved when BV-Endo pacing was highly site specific .


Within individuals , the best pacing modality varied and was affected by the underlying substrate .


Left ventricular activation times did not predict the optimal haemodynamic configuration .


Biventricular endocardial pacing and not MSP was superior to conventional CRT , but was highly site specific .


Within individuals , however , different methods of stimulation are optimal and may need to be tailored to the underlying substrate .


To compare the efficacy difference among acupuncture smoothing-liver and regulating-spleen method , regulating Governor Vessel method and oral administration of western medicine for menopausal insomnia .


One hundred and fifty-six cases of menopausal insomnia were randomized into a smoothing-liver and regulating-spleen group ( group A ) , a regulating Governor Vessel group ( group B ) and a medication group ( group C ) , 52 cases in each one .


Acupuncture at Zhongwan ( CV 12 ) , Daheng ( SP 15 ) , Sanyinjiao ( SP 6 ) and Taichong ( LR 3 ) , etc. was applied in the group A ; acupuncture at Baihui ( GV 20 ) , Fengfu ( GV 16 ) , Shenting ( GV 24 ) and Yintang ( GV 29 ) , etc. was used in the group B ; oral administration of estazolam tablets ( 1 mg each-day ) was adapted in the group C , all once a day for totally 30 days .


The each item score and total score in Pittsburgh sleep quality index ( PSQI ) were evaluated before and after treatment in each group , also the efficacy in each group was assessed .


After the treatment , the sleeping rate in the group A and B was significantly higher than that in the group C ( both P < 0.05 ) ; the total effective rate in the Group A and B was also significantly higher than that in the group C [ 86.5 % ( 45/52 ) and 82.7 % ( 43/52 ) vs 63.5 % ( 33/52 ) , both P < 0.05 ; the total cured rate in the group A was significantly higher than those in the group B and C [ 48.1 % ( 25/52 ) vs 23.1 % ( 12/52 ) and 25.0 % ( 13/52 ) , both P < 0.05 ] .


Each item score and total score of PSQI were all improved after treatment in the group A and B ( P < 0.01 , P < 0.05 ) , while only sleeping time , sleeping efficiency and total score were improved in the group C ( all P < 0.05 ) .


The sleeping quality , sleeping time , sleeping difficulty and daytime dysfunction in the group A were all lower than those in the group C ( all P < 0.05 ) .


The sleeping quality , sleeping time and daytime dysfunction in the goup B were all lower than those in the group C ( all P < 0.05 ) .


The total score in the group A was significantly lower than that in the group B and C ( both P < 05 ) .


Acupuncture has better effect for menopausal insomnia than estazolam .


Between the two acupuncture methods , the acupuncture method of smoothing-liver and regulating-spleen has a better effect .


The aim of the present study was to evaluate the acute effects of resistance exercise ( RE ) leading to failure and RE that was not to failure on 24 h blood pressure ( BP ) and heart rate variability ( HRV ) in sedentary normotensive adult women .


Ten women ( 33.2 5.8 years ; 159.3 9.4 cm ; 58.0 6.4 kg ; body fat 28.4 2.8 % ) randomly underwent three experimental sessions : control ( 40 minutes of seated rest ) , RE leading to failure with 3 sets of 10 repetitions maximum ( 10-RM ) , and RE not to failure at 60 % of 10-RM with 3 sets of 10 repetitions .


Immediately post session BP and HRV were measured for 24 h.


Ratings of perceived exertion and heart rate were higher during the 10-RM session when compared with 60 % of 10-RM ( 6.4 0.5 vs 3.5 0.8 and 123.7 13.9 vs 104.5 7.3 bpm , respectively ) .


The systolic , diastolic and mean BP decreased at 07:00 a.m. after the 10-RM session when compared with the control session ( -9.0 7.8 mmHg , -16.0 12.9 mmHg and -14.3 11.2 mmHg , respectively ) .


The root mean square of the squared differences between R-R intervals decreased after both the 60 % of 10-RM and 10-RM sessions compared with the control session .


An acute RE session leading to failure induced a higher drop of BP upon awakening , while both RE sessions reduced cardiac parasympathetic modulation .


RE may be an interesting training strategy to acutely decrease BP in adult women .


Noninvasive mechanical ventilation ( NIMV ) is an approach to prevent complications in acute respiratory failure .


In this study we aimed to compare the efficacy of a full face mask and a helmet in chronic obstructive pulmonary disease ( COPD ) .


Fifty patients were divided randomly into 2 groups as full face mask ( Group F ) and helmet ( Group H ) .


Demographic data , forced expiratory volume at 1 s ( FEV1 ) , additional disease , hemodynamic parameters , respiratory rate , APACHE II score , peripheral O2 saturation ( SpO2 ) , arterial blood gases ( ABG ) , patient tolerance scale ( PTS ) score , and fraction of inspired oxygen ( FiG2 ) were recorded .


Parameters were recorded as follows : 20 min before the NIMV ; every 30 min of NIMV until 120 min ; 30 min , 24 h , and 48 h after NIMV ; and prior to intensive care unit discharge .


The SpO2 , PTS , ABG , complication rate , and APACHE II scores were not different between the groups ( P > 0.05 ) .


The decrease in PaCO2 was statistically significant at 60 min in Group F ( P < 0.05 ) , and there was no statistical difference in Group H ( P < 0.05 ) according to initial PaCO2 values .


Both masks are efficient in improving the patients ' outcome in COPD , but the decrease in PaCO2in the helmet group was slower than in the full face mask group .


Small early postoperative hemodynamic differences were noted in a randomized comparison of 3 current-generation bioprosthetic aortic valves .


Whether these differences persist and influence clinical outcomes 1 year following implantation is unknown .


Three hundred adults with severe aortic stenosis undergoing valve replacement were randomized to receive the Epic ( St Jude , St Paul , Minn ) ( n = 99 ) , Magna ( Edwards LifeSciences Inc , Irvine , Calif ) ( n = 100 ) , or Mitroflow ( Sorin Biomedica Spa , Saluggio , Italy ) ( n = 101 ) bioprostheses .


Hemodynamic valve performance was examined by echocardiography at 1 year , and clinical outcomes were assessed in 241 patients ( 79 Epic , 77 Magna , and 85 Mitroflow ; P = .437 ) .


Mean age was 75 8 years and 164 were men ( 68 % ) .


Between dismissal and 1 year there were 9 deaths ( 3.7 % ) ( Epic : 3.7 % , Magna : 5.0 % , and Mitroflow : 2.3 % ; P = .654 ) , 6 episodes of heart failure ( 2.5 % ) ( Epic :1.3 % , Magna : 1.3 % , and Mitroflow : 5.8 % ; P = .265 ) , 27 instances of atrial fibrillation/flutter ( 11.2 % ) ( Epic : 8.1 % , Magna : 11.0 % , and Mitroflow : 7.9 % ; P = .577 ) and no strokes/transient ischemic attacks .


One-year echocardiography demonstrated small hemodynamic differences between Epic , Magna , and Mitroflow bioprostheses in mean gradient ( 15.2 5.5 , 12.3 4.3 , and 16.2 5.7 mm Hg , respectively ; P < .001 ) and indexed aortic valve area ( 0.93 0.28 , 1.04 0.28 , and 0.96 -0.26 cm ( 2 ) / m ( 2 ) , respectively ; P = .015 ) .


Several early trends persisted when stratifying data by echocardiographic annulus diameter , universal annulus size , and implant size , particularly with annular size 23 mm .


Overall left ventricular mass index regression between dismissal and 1 year was -16.5 28.1 g/m ( 2 ) , and was similar among groups ( P = .262 ) .


There were no aortic valve reoperations .


Despite midterm persistence of small hemodynamic differences amongst current-generation porcine and pericardial aortic valves , our prospective randomized comparison reveals that clinical outcomes and mass regression are equivalent between devices at 1 year .


These encouraging trends must continue to be assessed during longitudinal follow-up .


A randomized crossover trial was designed to analyze the impact of a short-term , isoenergetic fat-rich or carbohydrate ( CHO ) - rich diet on substrate oxidation rates during submaximal exercise and on performance in a 10,000-m running time trial in trained , mid - to late-pubertal boys .


An incremental test was performed to determine the peak oxygen uptake ( VO2peak ) .


After 2 days on a fat-rich ( 24.2 % 0.8 % CHO , 60.4 % 0.3 % fat , and 15.5 % 1.0 % protein ) , CHO-rich ( 69.3 % 1.2 % CHO , 15.9 % 2.1 % fat , and 15.1 % 1.1 % protein ) , or habitual ( 56.1 % 7.0 % CHO , 27.5 % 4.9 % fat , and 16.5 % 4.0 % protein ) diet , 19 trained adolescent boys ( 15.21.5 years ) performed a 10-minute constant run at 65 % VO2peak to determine the respiratory exchange ratio ( RER ) during exercise and 10,000-m running on an outdoor track .


During the constant run , the RER and CHO contribution to energy expenditure were lower , and fat contribution higher , in the fat-rich diet than in the CHO-rich diet ( P < 0.05 ) , but the results were not different from those of the habitual diet .


Performance in the 10,000-m run after consuming CHO - and fat-rich diets was similar to performance after a habitual diet ( 50.07.0 , 51.98.3 , and 50.97.4 minutes , respectively ) , but consuming a CHO-rich diet enhanced performance compared with that after a fat-rich diet ( P = 0.03 ) .


These findings indicate that a CHO-rich diet provides additional benefits to 10,000-m running performance in trained adolescent boys compared with a fat-rich diet .


To assess the efficacy of inhibitory repetitive transcranial magnetic stimulation ( rTMS ) for decreasing upper-limb muscle tone after chronic stroke .


A randomized sham-controlled trial with a 4-week follow-up .


Research hospital .


Patients with stroke ( N = 20 ) with poststroke upper limb spasticity .


The experimental group received rTMS to the primary motor cortex of the unaffected side ( 1500 pulses ; 1Hz ; 90 % of resting motor threshold for the first dorsal interosseous muscle ) in 10 sessions , 3d/wk , and physical therapy ( PT ) .


The control group received sham stimulation and PT .


Modified Ashworth scale ( MAS ) , upper-extremity Fugl-Meyer assessment , FIM , range of motion , and stroke-specific quality-of-life scale .


All outcomes were measured at baseline , after treatment ( postintervention ) , and at a 4-week follow-up .


A clinically important difference was defined as a reduction of 1 in the MAS score .


Friedman test revealed that PT is efficient for significantly reducing the upper limb spasticity of patients only when it is associated with rTMS .


In the experimental group , 90 % of the patients at postintervention and 55.5 % at follow-up showed a decrease of 1 in the MAS score , representing clinically important differences .


In the control group , 30 % of the patients at postintervention and 22.2 % at follow-up experienced clinically meaningful changes .


There were no differences between the groups at any time for any of the other outcome measures , indicating that both groups demonstrated similar behaviors over time for all variables .


rTMS associated with PT can be beneficial in reducing poststroke spasticity .


However , more studies are needed to clarify the clinical changes underlying the reduction in spasticity induced by noninvasive brain stimulations .


Odors are powerful emotional stimuli influencing mood , attention and behavior .


Here we examined if odors change the perception of pleasant touch .


In line with the warning function of the olfactory system , we proposed that especially unpleasant odors will reduce touch pleasantness , presumably through a disgust-related mechanism .


Forty-five healthy participants ( mean age 23.3 + / - 3years SD , 24 females ) were presented to slow ( 3 cm/s ) and fast ( 30 cm/s ) brush stroking delivered by a robot to the forearm .


Touch pleasantness under the influence of an unpleasant odor ( Civette , smelling like feces ) and an intensity matched pleasant odor ( Rose ) was compared to an odorless control condition .


In a pilot study with 30 participants ( mean age 25.9 + / -6 years , 21 females ) , the odors were matched according to their intensity , and we studied the influence of disgust sensitivity on the perception of 4 different odor qualities .


The unpleasant odor decreased touch pleasantness for both stroking velocities compared to the odorless control ( p < 0.005 ) whereas the rose odor did not change touch pleasantness significantly .


Disgust sensitivity was correlated with the modulation of touch pleasantness .


The pilot study revealed a significant correlation between disgust sensitivity and the perception of the unpleasant odor qualities ( r = -0.56 ; p = 0.007 ) , but not with any of the other odors .


Unpleasant odors are powerful in modulating touch pleasantness , and disgust might be a moderating variable .


Congenital infection with human cytomegalovirus ( CMV ) is a major cause of morbidity and mortality .


In an uncontrolled study published in 2005 , administration of CMV-specific hyperimmune globulin to pregnant women with primary CMV infection significantly reduced the rate of intrauterine transmission , from 40 % to 16 % .


We evaluated the efficacy of hyperimmune globulin in a phase 2 , randomized , placebo-controlled , double-blind study .


A total of 124 pregnant women with primary CMV infection at 5 to 26 weeks of gestation were randomly assigned within 6 weeks after the presumed onset of infection to receive hyperimmune globulin or placebo every 4 weeks until 36 weeks of gestation or until detection of CMV in amniotic fluid .


The primary end point was congenital infection diagnosed at birth or by means of amniocentesis .


A total of 123 women could be evaluated in the efficacy analysis ( 1 woman in the placebo group withdrew ) .


The rate of congenital infection was 30 % ( 18 fetuses or infants of 61 women ) in the hyperimmune globulin group and 44 % ( 27 fetuses or infants of 62 women ) in the placebo group ( a difference of 14 percentage points ; 95 % confidence interval , -3 to 31 ; P = 0.13 ) .


There was no significant difference between the two groups or , within each group , between the women who transmitted the virus and those who did not , with respect to levels of virus-specific antibodies , T-cell-mediated immune response , or viral DNA in the blood .


The clinical outcome of congenital infection at birth was similar in the two groups .


The number of obstetrical adverse events was higher in the hyperimmune globulin group than in the placebo group ( 13 % vs. 2 % ) .


In this study involving 123 women who could be evaluated , treatment with hyperimmune globulin did not significantly modify the course of primary CMV infection during pregnancy .


( Funded by Agenzia Italiana del Farmaco ; CHIP ClinicalTrials.gov number , NCT00881517 ; EudraCT no. 2008-006560-11 . )


Photodynamic therapy ( PDT ) using 5-aminolevulinic acid ( ALA ) with red light is well established for actinic keratosis ( AK ) .


Differences have been observed concerning pain and efficacy rates with different red light sources .


To compare pain scores , short - and long-term efficacy rates of PDT of multiple AKs when employing different red light sources .


In a controlled trial , 88 patients ( 310 AK lesions ) received ALA-PDT in combination with either visible light ( VIS ) + water-filtered infrared A ( wIRA ) light ( PhotoDyn ( ) 750 ( PD750 ) , 580-1400nm ) for 30 min or incoherent light ( Waldmann ( ) 1200L ( Wa1200L ) , 600-720nm ) for 10-11 min .


Follow-up visits were performed after 1 , 3 , 6 , and 12 months .


If there was no complete cure after 1 , 3 or 6 months , a second cycle of PDT was performed .


Pain scores were significantly lower in patients illuminated with PD750 rather than Wa1200L .


Patient complete clearance rates were 85 % and 91 % after 1 month , 79 % and 92 % after 3 months , 97 % and 92 % after 6 months , and 69 % and 85 % after 12 months in the PD750 and Wa1200L groups , respectively .


Lesion complete clearance rates were 94 % and 92 % after 1 month , 88 % and 97 % after 3 months , 96 % and 95 % after 6 months , and 81 % and 89 % after 12 months in the PD750 and Wa1200L group , respectively .


The efficacy rates were not significantly different .


A VIS + wIRA light source produced considerably less pain , while efficacy was not much affected in contrast to previously published studies , probably because the illumination time was longer in this study .


Biological explanations of psychopathology can reduce the extent to which people with mental disorders are blamed for their symptoms but can also yield prognostic pessimism -- the belief that psychiatric conditions are relatively immutable .


However , few studies have examined whether these effects occur among persons who actually have psychiatric symptoms .


This study sought to address this question .


Adults living in the United States ( N = 351 ) were recruited online in January and February 2012 and assessed for symptoms of generalized anxiety disorder .


The participants were randomly assigned to two groups : a biological condition , in which participants ( N = 176 ) were provided a description of generalized anxiety disorder and a biological explanation of the etiology of the disorder , and a control condition , in which participants ( N = 175 ) were provided the same description without any explanation of etiology .


Dependent measures of treatability , duration of symptoms , and responsibility for symptoms were used to gauge beliefs regarding the prognosis and personal responsibility of a typical person with generalized anxiety disorder .


Among participants with and without symptoms of generalized anxiety disorder , the biological condition was associated with decreased ascriptions of personal responsibility for anxiety ( p = .02 ) and expectations of increased duration of symptoms of generalized anxiety disorder ( p = .01 ) .


This finding has important social and clinical implications , especially because biological conceptualizations of psychopathology are increasingly prevalent .


By causing prognostic pessimism about generalized anxiety disorder , including among those with symptoms of the disorder , biological explanations could negatively affect treatment seeking and outcomes .


Efforts to dispel the link between biological explanations and prognostic pessimism are needed .


Perinatal complications predict increased risk for morbidity and early mortality .


Evidence of perinatal programming of adult mortality raises the question of what mechanisms embed this long-term effect .


We tested a hypothesis related to the theory of developmental origins of health and disease : that perinatal complications assessed at birth predict indicators of accelerated aging by midlife .


Perinatal complications , including both maternal and neonatal complications , were assessed in the Dunedin Multidisciplinary Health and Development Study cohort ( N = 1037 ) , a 38-year , prospective longitudinal study of a representative birth cohort .


Two aging indicators were assessed at age 38 years , objectively by leukocyte telomere length ( TL ) and subjectively by perceived facial age .


Perinatal complications predicted both leukocyte TL ( = -0.101 ; 95 % confidence interval , -0.169 to -0.033 ; P = .004 ) and perceived age ( = 0.097 ; 95 % confidence interval , 0.029 to 0.165 ; P = .005 ) by midlife .


We repeated analyses with controls for measures of family history and social risk that could predispose to perinatal complications and accelerated aging , and for measures of poor health taken in between birth and the age-38 follow-up .


These covariates attenuated , but did not fully explain the associations observed between perinatal complications and aging indicators .


Our findings provide support for early-life developmental programming by linking newborns ' perinatal complications to accelerated aging at midlife .


We observed indications of accelerated aging `` inside , '' as measured by leukocyte TL , an indicator of cellular aging , and `` outside , '' as measured by perceived age , an indicator of declining tissue integrity .


A better understanding of mechanisms underlying perinatal programming of adult aging is needed .


To assess the safety and efficacy of multiple injections of 0.5 and 2.0 mg conbercept using variable dosing regimens in patients with neovascular age-related macular degeneration ( AMD ) .


Randomized , double-masked , multicenter , controlled-dose , and interval-ranging phase 2 clinical trial divided into a 3-month loading phase followed by a maintenance phase .


Patients with choroidal neovascularization secondary to AMD with lesion sizes of 12 disc areas or less and a best-corrected visual acuity ( BCVA ) letter score of between 73 and 24 were enrolled .


Patients were randomized 1:1 to receive either 0.5 or 2.0 mg intravitreal conbercept for 3 consecutive monthly does .


After the third dose , each group was reassigned randomly again to monthly ( Q1M group ) or as-needed ( pro re nata [ PRN ] group ) treatment without changing the drug assignment .


The primary end point was the mean change in BCVA from baseline to month 3 , with secondary end points being the mean change in BCVA , mean change in central retinal thickness ( CRT ) , and safety at month 12 .


We enrolled 122 patients .


At the primary end point at month 3 , mean improvements in BCVA from baseline in the 0.5 - and 2.0-mg groups were 8.97 and 10.43 letters , respectively .


At month 12 , mean improvements in BCVA from baseline were 14.31 , 9.31 , 12.42 , and 15.43 letters for the 0.5-mg PRN , 0.5-mg Q1M , 2.0-mg PRN , and 2.0-mg Q1M regimens , respectively .


At month 12 , mean reductions in CRT in the 4 regimens were 119.8 , 129.7 , 152.1 , and 170.8 m , respectively .


There were no significant differences for the pairwise comparisons between all study groups .


The difference in the number of injections between the 2 PRN groups was not statistically significant .


Treatment with conbercept generally was safe and well tolerated .


The significant gains in BCVA at 3 months were the same or better at 12 months in all conbercept dosing groups of neovascular AMD patients .


During the 12 months , repeated intravitreal injections of conbercept were well tolerated in these patients .


Future clinical trials are required to confirm its long-term efficacy and safety .


Acute tympanostomy-tube otorrhea is a common sequela in children with tympanostomy tubes .


Acute tympanostomy-tube otorrhea is generally a symptom of an acute middle ear infection , whereby middle ear fluid drains through the tube .


The widespread use of pneumococcal conjugate vaccination ( PCV ) has changed the bacterial prevalence in the upper respiratory tract of children , but its impact on bacterial and viral pathogens causing acute tympanostomy-tube otorrhea is yet unknown .


This study was performed in the post-PCV7 era parallel to a randomized clinical trial of the clinical and cost-effectiveness of ototopical and systemic antibiotics and initial observation in 230 children aged 1 to 10 years with untreated , uncomplicated acute tympanostomy-tube otorrhea .


Otorrhea and nasopharyngeal samples were collected at baseline ( before treatment ) and at 2 weeks ( after treatment ) .


Conventional bacterial culture was performed followed by antimicrobial-resistance assessment .


Viruses were identified by polymerase chain reaction .


At baseline , Haemophilus influenzae ( 41 % ) , Staphylococcus aureus ( 40 % ) and Pseudomonas aeruginosa ( 18 % ) were the most prevalent bacteria in otorrhea , followed by Streptococcus pneumoniae ( 7 % ) and Moraxella catarrhalis ( 4 % ) .


Most pneumococci were non-PCV7 serotypes .


Viruses were detected in 45 otorrhea samples at baseline ( 21 % ) .


Most infections were polymicrobial and overall antimicrobial resistance was low .


H. influenzae , S. aureus and P. aeruginosa are the most common microorganisms in children with untreated uncomplicated acute tympanostomy-tube otorrhea .


Prevalence of S. pneumoniae has decreased since the introduction of PCV and most pneumococci are nonvaccine serotypes .


To investigate the difference in clinical outcomes between large-diameter deep anterior lamellar keratoplasty ( L-DALK ) and standard DALK ( S-DALK ) for the treatment of keratoconus .


132 patients ( 132 eyes ) from the Zhongshan Ophthalmic Center with a clinical diagnosis of keratoconus were enrolled .


The participants were featured by the intolerance to rigid gas-permeable contact lenses or unsuccessful fitting of contact lenses .


Using stratified blocked randomisation , eligible eyes were allocated into the L-DALK group or the S-DALK group ( 66 eyes , respectively ) .


Postoperative uncorrected visual acuity ( UCVA ) , best spectacle-corrected visual acuity ( BSCVA ) , refractive sphere , manifest cylinder and spherical equivalent refractive error were tested at 6 , 12 , 18 and 24months after surgery .


After surgery , the L-DALK group had better UCVA and BSCVA than the S-DALK group ( p = 0.000 and 0.021 , respectively ) .


At 24months , mean BSCVA was 0.170.10 logarithm of the minimum angle of resolution ( logMAR ) ( Snellen equivalent , 20/25 ) in the L-DALK group vs 0.220.10 logMAR ( Snellen equivalent , 20/32 ) in the S-DALK group .


Differences were observed between the L-DALK group and the S-DALK group in terms of refractive sphere ( p = 0.015 ) , manifest cylinder ( p = 0.014 ) and spherical equivalent refractive error ( p = 0.034 ) at any time interval postoperatively .


At 24months , the mean spherical equivalent refractive error was -3.53.2 D and -5.22.6 D in the L-DALK and S-DALK groups , respectively .


L-DALK can reduce the degree of postoperative myopia and manifest astigmatism and improve visual acuity outcomes in keratoconus compared with S-DALK .


Chinese Clinical Trial Registry ( TRC-13003122 ) .


Although circumferential pulmonary vein isolation ( CPVI ) has been considered as the cornerstone for paroxysmal atrial fibrillation ( PAF ) ablation , there has been a substantial recurrence rate .


We conducted a prospectively randomized study to evaluate whether additional linear ablation from the superior vena cava ( SVC ) to the right atrial ( RA ) septum ( SVC-L ) improves the clinical outcome .


This study enroled 200 patients with PAF ( male 74.5 % , 56.8 11.7 years old ) randomly assigned to either the CPVI ( n = 100 ) or CPVI + SVC-L ( n = 100 ) groups .


An RA isthmus ablation was performed in all patients .


The CPVI + SVC-L group required a longer ablation procedure time ( 82.7 17.9 min ) than the CPVI group ( 63.6 16.8 min , P < 0.001 ) .


The complication rates were 5 % in CPVI + SVC-L group and 2 % in CPVI group , respectively ( P = 0.445 ) .


Two CPVI + SVC-L group patients had post-procedural sinus node dysfunction , which recovered within 24 h.


During 12.2 5.3 months of follow-up , the recurrence rate was significantly lower in the CPVI + SVC-L group ( 6 % ) than the CPVI group ( 27 % , P < 0.001 ) .


The post-procedural 3-month follow-up heart rate variability in the CPVI + SVC-L group showed a significantly greater reduction in the rMSSD ( 25.2 13.7 vs. 13.7 8.5 ms , P < 0.001 ) , HF ( 10.2 7.1 vs. 5.5 5.8 ms ( 2 ) , P < 0.001 ) , and LF/HF ( 1.6 0.5 vs. 0.9 0.3 , P < 0.001 ) than in the CPVI group .


In spite of a longer procedure time and risk of transient sinus node dysfunction , an SVC-L in addition to CPVI improved the clinical outcome of catheter ablation , and was associated with post-procedural autonomic neural remodelling in patients with PAF .


To compare the clinical efficacy of 3 different treatment programs for oligospermia patients of Shen-essence deficiency syndrome ( SEDS ) .


Totally 450 male patients were randomly assigned to 3 groups , i.e. , the treatment group , the control group 1 , and the control group 2 , 150 in each group .


Patients in the treatment group were treated by Bushen Yijing Decoction ( BYD ) , tamoxifen tablet ( TT ) , Licorzine Capsule ( LC ) , and Vitamin E Soft Capsule ( VESC ) .


Those in the control group 1 were treated by BYD , LC , and VESC .


Those in the control group 2 were treated by TT , LC , and VESC .


All patients were treated for 3 months .


Their pregnant rates were compared .


Clinical efficacies of each Chinese medical symptom and sperm parameters [ sperm density , grade a sperm motility rate , grade ( a + b ) sperm motility rate , grade ( a + b + c ) sperm motility rate , and normal sperm morphology rate ] were compared before and after treatment .


At 3 months after treatment 61 patients were pregnant in the treatment group , 36 patients were pregnant in the control group 1 , and 30 patients were pregnant in the control group 2 .


The differences in the sperm density , grade a sperm motility rate , and grade ( a + b ) sperm motility rate , and grade ( a + b + c ) sperm motility rate between before and after treatment were significantly higher in the treatment group than in the control group 1 and the control group 2 ( P < 0.01 ) .


The difference in the normal sperm morphology rate between before and after treatment was obviously higher in the treatment group and the control group 1 than in the control group 2 ( P < 0.01 ) .


Better results were obtained in the treatment group and the control group 1 in improving the sexual apathy , soreness and weakness of waist and knees , impotence , premature ejaculation , seminal emission , dizziness , tinnitus , forgetfulness , alopecia , when compared with the control group 2 ( P < 0.01 , P < 0.05 ) .


There was no statistical difference in the total effective rate of improving Chinese medical symptoms between the treatment group and the control group 1 ( P > 0.05 ) .


BYD combined with TT , LC , and VESC could significantly improve sperm qualities and clinical Chinese medical symptoms of oligospermia patients of SEDS .


Low-level laser therapy ( LLLT ) has been proven to stimulate bone repair , affecting cellular proliferation , differentiation and adhesion , and has shown a potential to reduce the healing time following implant placement .


The aim of this clinical study was to investigate the influence of postoperative LLLT osseointegration and early success of self-tapping implants placed into low-density bone .


Following the split-mouth design , self-tapping implants n = 44 ) were inserted in the posterior maxilla of 12 patients .


One jaw side randomly received LLLT ( test group ) , while the other side was placebo ( control group ) .


For LLLT , a 637 nm gallium-aluminum-arsenide ( GaAlAs ) laser ( Medicolaser 637 , Technoline , Belgrade , Serbia ) with an output power of 40 mW and continuous wave was used .


Low-level laser treatment was performed immediately after the surgery and then repeated every day in the following 7 days .


The total irradiation dose per treatment was 6.26 J/cm2 per implant .


The study outcomes were : implant stability , alkaline-phosphatase ( ALP ) activity and early implant success rate .


The follow-up took 6 weeks .


Irradiated implants achieved a higher stability compared with controls during the entire follow-up and the difference reached significance in the 5th postoperative week ( paired t-test , p = 0.030 ) .


The difference in ALP activity between the groups was insignificant in any observation point ( paired t-test , p > 0.05 ) .


The early implant success rate was 100 % , regardless of LLLT usage .


LLLT applied daily during the first postoperative week expressed no significant influence on the osseointegration of self-tapping implants placed into low density bone of the posterior maxilla .


Placement of self-tapping macro-designed implants into low density bone could be a predictable therapeutic procedure with a high early success rate regardless of LLLT usage .


Routine placement of JJ ure teric stents , following uncomplicated endoscopic removal of a ureteral stone , still remains debatable .


Indwelling JJ stents are not without any risks .


They often can cause marked discomfort , or even pain .


The aim of this study was to prospectively evaluate patient 's perceived pain due to renal colic and indwelling JJ stent left following ure terorenoscopic lithotripsy ( URSL ) .


54 patients with colicky pain due to distal ureteric stone , and who underwent uncompli cated ureterorenoscopic lithotripsy , were included in the study .


Follow ing URSL , patients were randomly selected to have either JJ stent left in situ ( Group I ) , or remain without a stent ( Group II ) .


Among all study par ticipants levels of pain prior , as well as 14 days after the procedure were evalu ated with the use of a visual analogue pain scale .


Pain perception at the time of colic did not vary between men and women ( 6.30 + / - 1.33 and 6.38 + / - 1.11 , respectively , p = 0.293 ) .


Similarly , no differences in perceived pain were noted 14 days following URSL .


Mean pain score in patients with indwelling JJ stent was 2.12 + / - 1.23 as compared to 2.15 + / - 0.67 in those without it ( p = 0.148 ) .


No increase in pain levels due to indwelling JJ stent could be observed .


Further research to allow for better assessment of discomfort and pain caused by an indwelling JJ stent on a larger cohort , and which could also discriminate patients ' psy chosomatic symptoms , is needed .


Adherence to controller therapy in allergic diseases is low .


Telemonitoring has been proposed to improve adherence to treatment in chronic diseases .


However , this strategy has never been tested in allergic rhinoconjunctivitis .


To test whether Internet-based telemonitoring during the grass-pollen season of children with allergic rhinoconjunctivitis may enhance adherence to treatment .


Children and adolescents , 5-18years old , with moderate-to-severe seasonal allergic rhinoconjunctivitis to grass pollen requiring daily administration of nasal corticosteroid ( NCS ) ( mometasone ) were recruited ( April 2013 ) in a paediatric allergy practice .


Participants were randomized to Internet-based monitoring ( AllergyMonitor ( ) , AM ) or to usual care ( no diary at all , controls ) and followed from 13 May ( T0 ) to 15 June 2013 ( T2 ) .


An intermediate visit ( T1 ) was performed between 31 May and 2 June .


Optimal adherence to therapy was expressed as the use of at least 0.190 g/day of mometasone , corresponding to 1puff/nostril/day , and it was measured by canister weights during ( T1 ) and at the end ( T2 ) of the study period .


Main secondary outcomes included the reported disease severity ( validated self-questionnaire ) and quality of life ( AdoIRQLQ questionnaire ) , disease knowledge ( multiple-choice questionnaire ) , nasal flow and resistance at baseline and at T2 .


The use of mometasone , expressed as both optimal adherence rate ( 48.4 % vs. 12.5 % ; P = 0.002 ) and average daily use ( 0.200.12 g/day vs. 0.150.07 g/day ; P = 0.037 ) , was higher in the AM group ( n = 31 ) than among controls ( n = 32 ) .


Disease knowledge improved among the patients using AM ( 83.3 % vs. 68.3 % ; P < 0.001 ) but not among controls ( 68.2 % vs. 67.7 % right answers ; P > 0.05 ) .


No differences were observed in the reported severity of disease , nasal flow and resistance and quality of life both at baseline and at follow-up visits .


Internet-based telemonitoring improves adherence to NCS treatment and disease knowledge among children and adolescents with seasonal allergic rhinoconjunctivitis .


The aim of this study was to evaluate the combination of endoscopic ultrasonography ( EUS ) and computed tomography ( CT ) in predicting the maneuvers for therapeutic endoscopy for gastrointestinal submucosal tumors ( SMTs ) .


Patients with SMTs , who were scheduled for endoscopic resection , were randomized to preoperative performance of both EUS and CT ( group A ) or EUS only ( group B ) .


The following data were collected : therapeutic maneuvers , duration of procedure , dose of propofol , resected lesion size , and complications .


A total of 36 patients were included in group A and 36 patients were included in group B. Endoscopic submucosal excavation was performed in 43 patients , endoscopic full-thickness resection in 18 patients , and submucosal tunneling endoscopic resection in 11 patients .


No significant differences were observed between the two groups ( P > 0.05 ) .


The coincidence rate between the preoperative program and the actual endoscopic procedures in group A was higher than that in group B ( 83.3 vs. 61.1 % , P < 0.05 ) .


The procedural time in group A was less than that in group B ( 39.3617.83 vs. 48.0612.03 min , P < 0.05 ) , and the dose of propofol in group A was less than that in group B ( 249.18125.12 vs. 304.16102.61 mg , P < 0.05 ) .


The mean resected lesion size was 2.321.46 cm in group A and 2.120.75 cm in group B , without differences ( P > 0.05 ) .


A total of 14 cardiopulmonary complications and seven endoscopic complications occurred , without significant differences between the two groups ( P > 0.05 ) .


EUS combined with CT can better evaluate SMTs compared with EUS only in predicting the maneuvers for therapeutic endoscopy .


Sedentary behavior may independently contribute to morbidity and mortality among survivors of colorectal cancer .


In the current study , the authors assessed whether a telephone-delivered multiple health behavior change intervention had an effect on the sedentary behavior of recently diagnosed colorectal cancer survivors .


A total of 410 participants were recruited through the Queensland Cancer Registry and randomized to the health coaching ( intervention ) or usual-care ( control ) group .


Eleven health coaching sessions addressing multiple health behaviors , including sedentary behavior , were delivered over a period of 6 months .


Data were collected at baseline ( before randomization ) , at 6 months , and at 12 months via a telephone interview .


At 12 months , there was a significant decrease noted in the hours per day of sedentary time in both the health coaching ( -1.21 ; 95 % confidence interval [ 95 % CI ] , -1.71 to -0.70 ) and usual-care groups ( -0.55 ; 95 % CI , -1.06 to -0.05 ) , but the between-group difference was not found to be statistically significant ( -0.65 ; 95 % CI , -1.37 to 0.06 [ P = .07 ] ) .


In stratified subgroup analyses , the multiple health behavior change intervention was found to have a significant effect on total sedentary time ( hours/day ) at 12 months in survivors of colorectal cancer who were aged > 60 years ( -0.90 ; 95 % CI , -1.80 to -0.01 [ P = .05 ] ) , male ( -1.33 ; 95 % CI , -2.44 to -0.21 [ P = .02 ] ) , and nonobese ( -1.10 ; 95 % CI , -1.96 to -0.25 ; [ P = .01 ] ) .


Incorporating simple messages about limiting sedentary behaviors into a multiple health behavior change intervention was found to have modest effects on sedentary behavior .


A sedentary behavior-specific intervention strategy may be required to achieve substantial changes in sedentary behavior among colorectal cancer survivors .


Long-term nitrate treatment of stable angina is associated with side effects that can interfere with health-related quality of life ( HRQoL ) and medication adherence .


The aim of the present study was to compare HRQoL and adherence to treatment in patients with stable angina undergoing nitrate withdrawal or maintenance .


This study is a randomized clinical trial .


Patients were allocated to an intervention group ( nitrate withdrawal followed by introduction of placebo ) or a control group ( nitrate maintenance ) .


The assessments were made at baseline and 30 and 120 days using the Short Form Health Survey and the Seattle Angina Questionnaire .


Treatment adherence was measured on the basis of the Morisky scale and pill count .


A total of 105 patients with stable angina were randomized for replacement of nitrate with placebo ( n = 51 ) and for maintenance of treatment with nitrate ( n = 54 ) .


After 4 months , Short Form Health Survey scores increased for bodily pain ( P = 0.005 ) and general health ( P = 0.004 ) in the nitrate maintenance group .


Decreased Seattle Angina Questionnaire scores were also noted for physical limitations ( P = 0.039 ) and angina frequency ( P = 0.011 ) in the nitrate maintenance group .


However , the effect size was small ( 0.44 ) when the intervention and control groups were compared .


At the end of the study , adherence was significantly higher in the placebo group ( P = 0.041 ) , but no difference was detected between the groups with the pill count method .


HRQoL was similar in patients with stable angina using nitrate regularly as compared with patients undergoing nitrate withdrawal .


However , adherence to treatment was lower in nitrate users according to the Morisky scale .


Research on immediate neonatal resuscitation suggests that maternal magnesium exposure may be associated with increased risk of low Apgar scores , hypotonia , and neonatal intensive care unit admission .


However , not all studies support these associations .


Our objective was to determine whether exposure to magnesium at the time of delivery affects initial neonatal resuscitation .


This is a secondary analysis of the Randomized Controlled Trial of Magnesium Sulfate for the Prevention of Cerebral Palsy that evaluated whether the study drug ( magnesium or placebo ) that was administered at the time of delivery was associated with increased risk for a composite adverse neonatal resuscitation outcome ( 5-minute Apgar score < 7 , oxygen administration in the delivery room , intubation , chest compressions , hypotension , and hypotonicity ) .


A subgroup analysis was performed among patients who delivered at 30 weeks of gestation .


Log-linear regression was used to control for possible confounders .


Data for 1047 patients were analyzed , of whom 461 neonates ( 44 % ) were exposed to magnesium .


There was no increased risk for the primary composite outcome associated with magnesium exposure .


Individual adverse neonatal outcomes and other secondary short-term neonatal outcomes that were evaluated also did not demonstrate an association with magnesium exposure .


Exposure to magnesium sulfate did not affect neonatal resuscitation or other short-term outcomes .


These findings may be useful in planning neonatal care and patient counseling .


Controversy persists over statins and risk of intracerebral hemorrhage .


We determined associations of premorbid lipid-lowering therapy and outcomes among participants of the Intensive Blood Pressure Reduction in Acute Cerebral Hemorrhage Trials ( INTERACT ) .


The pooled data of INTERACT 1 and 2 ( international , multicenter , prospective , open , blinded end point , randomized controlled trials of patients with intracerebral hemorrhage [ < 6 hours ] and elevated systolic blood pressure ) were analyzed with regard to associations of baseline lipid-lowering treatment and clinical outcomes of 3184 participants in a multivariate model .


Associations of lipid-lowering therapy and hematoma growth ( baseline to 24 hours ) in computed tomographic substudies participants ( n = 1310 ) were estimated in ANCOVA .


Among 204 patients ( 6.5 % ) with baseline lipid-lowering treatment , 90-day clinical outcomes were not significantly different after adjustment for confounding variables including region and age .


In the computed tomographic substudy , 24-hour hematoma growth was greater in 124 patients ( 9 % ) with , compared with those without , prior lipid-lowering therapy .


However , this association was not significant between groups ( 9.2 versus 6.8 mL ; P < 0.13 ) , after adjustment for prior antithrombotic therapy .


No independent associations were found between lipid-lowering medication and adverse outcomes in patients with intracerebral hemorrhage .


http://www.clinicaltrials.gov .


Unique identifier : NCT00226096 and NCT00716079 .


Observational data have suggested that high dietary intake of saturated fat and low intake of vegetables may be associated with increased risk of Alzheimer disease .


To test the effects of oral supplementation with nutrients on cognitive function .