Ultrasound and LLLT provided significant improvements in pain and muscle extensibility , which were superior to no therapy but not to placebos , thus raising concerns about the suitability , both economically and ethically , of administering such common physical modalities as stand-alone treatments in active MTP of the uTM .


Integrated Treatment ( IT ) has proved effective in treating patients with Substance Use Disorders ( SUD ) co-occurring with severe Mental Disorders ( MD ) , less is known about the effectiveness of IT for patients with SUD co-occurring with less severe MD.The aim of this study was to investigate the effectiveness of IT for patients with SUD co-occurring with anxiety and/or depression on the following parameters :1 .


The use of substances , as measured by the Alcohol Use Identification Test ( AUDIT ) , the Drug Use Identification Test ( DUDIT ) , and the Addiction Severity Index ( EuropASI ) .2 .


The severity of psychiatric symptoms , as measured by the Symptom Check List 90 r ( SCL 90R ) .3 .


The client 's motivation for changing his/her substance use behaviour , as measured by the Substance Abuse Treatment Scale ( SATSr ) .


This is a group randomized clinical trial comparing the effectiveness of IT to treatment as usual in Community Mental Health Centres ( CMHCs ) .


Five CMHCs were drawn to the Intervention Group ( IG ) and four CMHCs to the Control Group ( CG ) .


The allocation to treatment conditions was not blinded .


New referrals were screened with the AUDIT and the DUDIT .


Those who scored above the cut-off level of these instruments were assessed with the Structured Clinical Interview for DSM-IV 1 and 2 .


We included patients with anxiety and/or depression together with one or more SUDs .


We included 55 patients in the IG and 21 in the CG .


A linear multilevel model was used .


Both groups reduced their alcohol and substance use during the trial , while there was no change in psychiatric symptoms in either group .


However , the IG had a greater increase in motivation for substance use treatment after 12 months than had the CG with an estimate of 1.76 , p = 0.043 , CI95 % ( 0.08 ; 3.44 ) ( adjusted analyses ) .


There were no adverse events .


Integrated treatment is effective in increasing the motivation for treatment amongst patients with anxiety and/or depression together with SUD in outpatient clinics .


ClinicalTrials.gov : NCT00447733 .


Early detection of colorectal cancer ( CRC ) using fecal occult blood test ( FOBT ) reduces mortality , yet screening adherence remains low .


Enhancing FOBT adherence in a field experiment , using Implementation Intentions ( II ) technique .


Participants were randomly assigned to a standard care group or to II experimental group .


A test kit was mailed to 29,833 HMO-insured members in two waves in 2011 .


eligible persons aged 50-74 who underwent the test the year before .


A sample of 2200 participants was interviewed over the telephone for possible cognitive and background moderators .


Leaflet attached to the test kit containing an `` if-then '' condition and planning instructions of when , where , and how .


Test performance at 2 and 6 months following mailing of the test kit , retrieved from HMO 's computerized database ( 2011-2012 ) .


Adherence in the experimental group ranged 1.2 % -6.6 % higher than in the control group .


Within 6 months of kits ' mailing , test uptake for the two waves was 71.4 % and 67.9 % for experiment and control , respectively ( ( 2 ) = 40.58 , p = 0.0001 ) .


The difference remained significant after controlling for age , gender , marital status , and wave ( OR = 1.17 , 95 % CI = 1.11 , 1.23 , p < 0.0001 ) .


Test performance was related to cognitive and background variables .


No interaction was found among cognitive or background variables and the intervention .


II technique is useful in increasing adherence to CRC screening , even in a mailed form rather than a face-to-face experimental situation .


Mailed II is an inexpensive and effective method , applicable for public health .


Because the diagnosis and treatment of carotid artery disease may reduce the rate of stroke , the aim of this study was to determine whether a diet intervention was associated with incident carotid artery disease .


Participants were 48 835 postmenopausal women aged 50 to 79 years who were randomly assigned to either the intervention or comparison group in the Women 's Health Initiative Diet Modification Trial .


Incident carotid artery disease was defined as an overnight hospitalization with either symptoms or a surgical intervention to improve flow .


After a mean follow-up of 8.3 years from 1994 to 2005 , there were 297 ( 0.61 % ) incident carotid artery events .


In contrast to the comparison group , the risk of incident carotid disease did not differ from those assigned to the intervention group ( hazard ratio , 1.08 ; 95 % confidence interval , 0.9-1 .4 ) .


In secondary analysis , there was no significant effect of the intervention on the risk for incident carotid disease during the 5 years of postintervention follow-up from 2005 to 2010 ( hazard ratio , 1.24 ; 95 % confidence interval , 0.9-1 .7 ) and no significant effect during cumulative follow-up from 1994 to 2010 ( hazard ratio , 1.13 ; 95 % confidence interval , 0.9-1 .4 ) .


Among postmenopausal women , a dietary intervention aimed at reducing total fat intake and encouraging increased intake of fruit , vegetables , and grains did not significantly change the risk for incident carotid artery disease .


http://www.clinicaltrials.gov .


Unique identifier : NCT00000611 .


Novel nicotine delivery products , such as electronic cigarettes ( e-cigarettes ) , have dramatically grown in popularity despite limited data on safety and benefit .


In contrast , the similar U.S. Food and Drug Administration ( FDA ) - approved nicotine inhaler is rarely utilized by smokers .


Understanding this paradox could be helpful to determine the potential for e-cigarettes as an alternative to tobacco smoking .


To compare the e-cigarette with the nicotine inhaler in terms of perceived benefits , harms , appeal , and role in assisting with smoking cessation .


A cross-over trial was conducted from 2012 to 2013 PARTICIPANTS/INTERVENTIONS : Forty-one current smokers age 18 and older used the e-cigarette and nicotine inhaler each for 3 days , in random order , with a washout period in between .


Thirty-eight participants provided data on product use , perceptions , and experiences .


The Modified Cigarette Evaluation Questionnaire ( mCEQ ) measured satisfaction , reward , and aversion .


Subjects were also asked about each product 's helpfulness , similarity to cigarettes , acceptability , image , and effectiveness in quitting smoking .


Cigarette use was also recorded during the product-use periods .


The e-cigarette had a higher total satisfaction score ( 13.9 vs. 6.8 [ p < 0.001 ] ; range for responses 3-21 ) and higher reward score ( 15.8 vs. 8.7 [ p < 0.001 ] ; range for responses 5-35 ) than the inhaler .


The e-cigarette received higher ratings for helpfulness , acceptability , and `` coolness . ''


More subjects would use the e-cigarette to make a quit attempt ( 76 % ) than the inhaler ( 24 % ) ( p < 0.001 ) .


Eighteen percent ( 7/38 ) of subjects abstained from smoking during the 3-day periods using the e-cigarette vs. 10 % ( 4/38 ) using the inhaler ( p = 0.18 ) .


The e-cigarette was more acceptable , provided more satisfaction , and had higher perceived benefit than the inhaler during this trial .


E-cigarettes have the potential to be important nicotine delivery products owing to their high acceptance and perceived benefit , but more data are needed to evaluate their actual efficacy and safety .


Providers should be aware of these issues , as patients will increasingly inquire about them .


Open label studies have shown repetitive transcranial magnetic stimulation to be effective in reducing tics .


To determine whether 8 sessions of continuous theta burst stimulation ( cTBS ) over supplementary motor area ( SMA ) given over 2 days may reduce tics and motor cortical network activity in Tourette syndrome/chronic tic disorders .


This was a randomized ( 1:1 ) , double-blind , sham-controlled trial of functional MRI ( fMRI ) - navigated , 30 Hz cTBS at 90 % of resting motor threshold ( RMT ) over SMA in 12 patients ages 10-22 years .


Comorbid ADHD ( n = 8 ) , OCD ( n = 8 ) , and stable concurrent medications ( n = 9 ) were permitted .


Neuro-navigation utilized each individual 's event-related fMRI signal .


Primary clinical and cortical outcomes were : 1 ) Yale Global Tic Severity Scale ( YGTSS ) at one week ; 2 ) fMRI event-related signal in SMA and primary motor cortex ( M1 ) during a finger-tapping motor task .


Baseline characteristics were not statistically different between groups ( age , current tic/OCD/ADHD severities , tic-years , number of prior medication trials , RMT ) .


Mean YGTSS scores decreased in both active ( 27.5 7.4 to 23.2 9.8 ) and sham ( 26.8 4.8 to 21.7 7.7 ) groups .


However , no significant difference in video-based tic severity rating was detected between the two groups .


Two-day post-treatment fMRI activation during finger tapping decreased significantly in active vs. sham groups for SMA ( P = 0.02 ) , left M1 ( P = 0.0004 ) , and right M1 ( P < 0.0001 ) .


No serious adverse events occurred .


Active , fMRI-navigated cTBS administered in 8 sessions over 2 days to the SMA induced significant inhibition in the motor network ( SMA , bilateral M1 ) .


However , both groups on average experienced tic reduction at 7 days .


Larger sample size and protocol modifications may be needed to produce clinically significant tic reduction beyond placebo effect .


Androgen deprivation therapy ( ADT ) is associated with significant bone loss and an increase in fracture risk among prostate cancer survivors ( PCS ) .


We investigated whether impact + resistance training could stop ADT-related declines in bone mineral density ( BMD ) among PCS on ADT .


We randomized 51 PCS ( mean age , 70.2 yr ) currently prescribed ADT to participate in 1 yr of impact + resistance training ( Prevent Osteoporosis with Impact + Resistance ( POWIR ) ) or in an exercise placebo program of stretching exercise ( FLEX ) .


Outcomes were proximal femur ( total hip , femoral neck , and greater trochanter ) and spine ( L1-L4 ) BMD ( gcm ) and bone turnover markers ( serum osteocalcin ( ngmL ) and urinary deoxypyrodinoline cross-links ( nmolmmol Cr ) ) .


Retention in the 1-yr study was 84 % and median attendance to supervised classes was 84 % in POWIR and 74 % in FLEX .


No study-related injuries were reported .


There were no significant differences between groups for average L1-L4 BMD or for BMD at any hip site .


When examining individual vertebrae , POWIR has a significant effect on preservation of BMD ( -0.4 % ) at the L4 vertebrae compared with losses ( -3.1 % ) in FLEX ( P = 0.03 ) .


Impact + resistance training was a safe and acceptable form of exercise for older PCS on ADT .


Among our limited sample , POWIR did not appear to have a clinically meaningful effect on hip or spine BMD , but some evidence of skeletal adaptation to resistance + impact training in an androgen-deprived state was apparent .


Future studies need to be conducted on a larger sample of patients and should consider modifications to POWIR that could further enhance loading across the spine and at the hip to preserve BMD at these clinically relevant sites .


To compare the differences in the clinical efficacy on post-stroke speech disorder between scalp electric acupuncture ( EA ) under anatomic orientation combined with rehabilitation training and simple rehabilitation training .


Sixty patients of post-stroke speech apraxia were randomized into an observation group and a control group , 30 cases in each one .


In the observation group , under anatomic orientation , the scalp EA was adopted to the dominant hemisphere Broca area on the left cerebrum .


Additionally , the speech rehabilitation training was combined .


In the control group , the speech rehabilitation training was simply , used .


The treatment lasted for 4 weeks totally .


The speech movement program module in the psychological language assessment and treatment system of Chinese aphasia was used for the evident of efficacy assessment .


The scores of counting , singing scale , repeating phonetic alphabet , repeating monosyllable and repeating disyllable were observed in the patients of the two groups .


The assessment was done separately on the day of grouping and 4 weeks after treatment .


In 4 weeks of treatment , the scores of counting , singing scale , repeating phonetic alphabet , repeating monosyllable and repeating disyllable were all improved as compared with those before treatment in the two groups ( all P < 0.001 ) .


The results in the observation group were better than those in the control group ( all P < 0.05 ) .


The total effective rate was 100.0 % ( 30/30 ) in the observation group , superior apparently to 53.3 % ( 16/30 ) in the control group ( P < 0.001 ) .


The scalp EA under anatomic orientation combined with ' speech rehabilitation training obviously improves speech apraxia in stroke patients so that the speech disorder cani be relieved .


The efficacy is better than that in simple rehabilitation training .


Effective pharmacotherapies to treat methamphetamine ( MA ) dependence have not been identified , and behavioral therapies are marginally effective .


Based on behavioral studies demonstrating the potential efficacy of aerobic exercise for improving depressive symptoms , anxiety , cognitive deficits , and substance use outcomes , the study described here is examining exercise as a potential treatment for MA-dependent individuals .


This study is randomizing 150 participants with MA dependence at a residential treatment facility for addictive disorders to receive either a thrice-weekly structured aerobic and resistance exercise intervention or a health education condition .


Recruitment commenced in March , 2010 .


Enrollment and follow-up phases are ongoing , and recruitment is exceeding targeted enrollment rates .


Seeking evidence for a possibly effective adjunct to traditional behavioral approaches for treatment of MA dependence , this study is assessing the ability of an 8-week aerobic and resistance exercise protocol to reduce relapse to MA use during a 12-week follow-up period after discharge from residential-based treatment .


The study also is evaluating improvements in health and functional outcomes during and after the protocol .


This paper describes the design and methods of the study .


To compare the efficacy and side effects of induction chemotherapy with vinorelbine plus cisplatin ( NP ) or docetaxel plus cisplatin ( TP ) combined with concurrent chemoradiotherapy in treating locally advanced nasopharyngeal carcinoma ( NPC ) .


From January 2005 to December 2009 , 146 patients with locally advanced nasopharyngeal carcinoma treated in our department were randomized into NP group ( 76 patients ) or TP group ( 70 patients ) .


Both groups received two cycles of induction chemotherapy and concurrent chemoradiotherapy .


After three weeks of induction chemotherapy , the patients received concurrent chemoradiotherapy .


The chemotherapy was recycled every three weeks .


Two groups were treated with intensity-modulated radiation therapy .


The short-term efficacy of NP group was similar to that of TP group .


The 3-year overall survival rates , disease-free-survival rates , locoregional relapse-free survival rates and distant metastasis-free survival rates in the NP and TP groups were 84.2 % and 82.9 % , 71.1 % and 74.3 % , 89.5 % and 91.4 % , 81.6 % and 77.1 % , respectively ( P > 0.05 ) .


The occurrence rates of leucopenia , anemia and acute mucositis were significantly higher in the TP group than those in the NP group ( P < 0.05 ) .


The gastrointestinal toxicity , dermatitis and liver toxicity were similar in the two groups .


The efficacy of NP regimen induction chemotherapy plus concurrent chemordiotherapy for advanced NPC is similar to that of TP regimen .


The toxicity of the NP regimen is lower than that of NP regimen , tolerable , and with a good compliance .


Depressive disorders occur in 2 to 5 % of the adolescents and are associated with a high burden of disease , a high risk of recurrence and a heightened risk for development of other problems , like suicide attempts .


The effectiveness of cognitive behaviour therapy ( CBT ) , cost-effectiveness of this treatment and the costs of illness of clinical depression in adolescents are still unclear .


Although several Randomized Controlled Trials ( RCT ) have been conducted to establish the efficacy of CBT , the effectiveness has not been established yet .


Aim of this study is to conduct a RCT to test the effectiveness of CBT and to establish the cost-effectiveness of CBT under rigorous conditions within routine care provided by professionals already working in mental health institutions .


CBT is investigated with a multi-site , RCT using block randomisation .


The targeted population is 140 clinically referred depressed adolescents aged 12 to 21years old .


Adolescents are randomly assigned to the experimental ( N = 70 , CBT ) or control condition ( N = 70 , TAU ) .


Four assessments ( pre , post , follow up at 6 and 12months ) and two mediator assessments during treatment are conducted .


Primary outcome measure is depression diagnosis based on a semi-structured interview namely the K-SADS-PL .


Secondary outcome measures include depressive symptoms , severity and improvement of the depression , global functioning , quality of life , suicide risk , comorbidity , alcohol and drug use , parental depression and psychopathology , parenting and conflicts .


Costs and treatment characteristics will also be assessed .


Furthermore , moderator and mediator analyses will be conducted .


This trial will be the first to compare CBT with TAU under rigorous conditions within routine care and with a complex sample .


Furthermore , cost-effectiveness of treatment and cost-of-illness of clinical depression are established which will provide new insights on depression as a disorder and its treatment .


Dutch Trial register number NTR2676 .


The study was financially supported by a grant from ZonMw , the Netherlands organization for health research and development , grant number 157004005 .


Video laparoscopic bariatric surgery is the preferred surgical technique for treating morbid obesity .


However , pneumoperitoneum can pose risks to the kidneys by causing a decrease in renal blood flow .


Furthermore , as in other surgical procedures , laparoscopic bariatric surgery triggers an acute inflammatory response .


Neutrophil gelatinase-associated lipocalin is an early and accurate biomarker of renal injury , as well as of the inflammatory response .


Anesthetic drugs could offer some protection for the kidneys and could attenuate the acute inflammatory response from surgical trauma .


The objective of this study was to compare the effects of two types of anesthetics , propofol and sevoflurane , on the serum levels of neutrophil gelatinase-associated lipocalin during the perioperative period in laparoscopic bariatric surgery .


Sixty-four patients scheduled for laparoscopic bariatric surgery were randomized into two anesthesia groups and were administered either total intravenous anesthesia ( propofol ) or inhalation anesthesia ( sevoflurane ) .


In the perioperative period , blood samples were collected at three time points ( before anesthesia , 6 hours after pneumoperitoneum and 24 hours after pneumoperitoneum ) and urine output was measured for 24 hours .


Acute kidney injuries were evaluated by examining both the clinical and laboratory parameters during the postoperative period .


The differences between the groups were compared using non-parametric tests .


ReBEC ( http://www.ensaiosclinicos.gov.br/rg/recruiting/ ) : RBR-8wt2fy


None of the patients developed an acute kidney injury during the study and no significant differences were found between the serum neutrophil gelatinase-associated lipocalin levels of the groups during the perioperative period .


The choice of anesthetic drug , either propofol or sevoflurane , did not affect the serum levels of neutrophil gelatinase-associated lipocalin during the perioperative period in laparoscopic bariatric surgery .


To compare postprandial efficacy in type 2 diabetic patients given mitiglinide and sitagliptin , both of which are known to improve postprandial hyperglycemia , by using continuous glucose monitoring ( CGM ) .


Eleven patients with type 2 diabetes were given mitiglinide 10 mg three times a daily or sitagliptin 50 mg once a day for 1 month and were hospitalized for 4 days and evaluated by CGM .


On discharge , they were crossed over to the other regimen for 1 month of treatment/4 days of evaluation .


The CGM data were used to compare each parameter for glycemic variability .


The patients were 60 10 ( mean SD ) years old , and had HbA1c value 7.3 0.9 % .


The pre-meal glucose levels before lunch were significantly lower with mitiglinide than with sitagliptin ( 116 26/131 34 mg/dl , p = 0.022 ) .


The AUC measuring over 140 mg/dl 3 h after breakfast ( mitiglinide 4812 4219/sitagliptin 7807 6391 mg/dlmin , p = 0.042 ) and lunch ( mitiglinide 5658 5856/sitagliptin 8492 7161 , p = 0.050 ) was significantly lower with mitiglinide than with sitagliptin .


A CGM-based comparison showed that mitiglinide and sitagliptin were different in their glucose-lowering effects , where mitiglinide significantly improved hyperglycemia after breakfast and lunch , and significantly lowered pre-meal glucose levels before lunch , compared to sitagliptin .


To test recommended implantable cardioverter defibrillator ( ICD ) follow-up methods by ` in-person evaluations ' ( IPE ) vs. ` remote Home Monitoring ' ( HM ) .


ICD patients were randomized 2:1 to automatic HM or to Conventional monitoring , with follow-up checks scheduled at 3 , 6 , 9 , 12 , and 15 months post-implant .


Conventional patients were evaluated with IPE only .


Home Monitoring patients were assessed remotely only for 1 year between 3 and 15 month evaluations .


Adherence to follow-up was measured .


HM and Conventional patients were similar ( age 63 years , 72 % male , left ventricular ejection fraction 29 % , primary prevention 73 % , DDD 57 % ) .


Conventional management suffered greater patient attrition during the trial ( 20.1 vs. 14.2 % in HM , P = 0.007 ) .


Three month follow-up occurred in 84 % in both groups .


There was 100 % adherence ( 5 of 5 checks ) in 47.3 % Conventional vs. 59.7 % HM ( P < 0.001 ) .


Between 3 and 15 months , HM exhibited superior ( 2.2 ) adherence to scheduled follow-up [ incidence of failed follow up was 146 of 2421 ( 6.0 % ) in HM vs. 145 of 1098 ( 13.2 % ) in Conventional , P < 0.001 ] and punctuality .


In HM ( daily transmission success rate median 91 % ) , transmission loss caused only 22 of 2275 ( 0.97 % ) failed HM evaluations between 3 and 15 months ; others resulted from clinic oversight .


Overall IPE failure rate in Conventional [ 193 of 1841 ( 10.5 % ) exceeded that in HM [ 97 of 1484 ( 6.5 % ) , P < 0.001 ] by 62 % , i.e. HM patients remained more loyal to IPE when this was mandated .


Automatic remote monitoring better preserves patient retention and adherence to scheduled follow-up compared with IPE .


NCT00336284 .


After the advent of the GreenLight XPS ( 180 W ) 532 nm laser , photoselective vapo-enucleation of the prostate could compete with holmium laser enucleation of the prostate as a size independent procedure .


We assessed whether photoselective vapo-enucleation of the prostate-XPS is not less effective than holmium laser enucleation of prostate for improvement of lower urinary tract symptoms secondary to benign prostatic hyperplasia .


A randomized controlled noninferiority trial comparing holmium laser enucleation of the prostate to photoselective vapo-enucleation of the prostate-XPS 180 W was conducted .


I-PSS , flow rate , residual urine , prostate specific antigen and prostate volume changes as well as perioperative and late adverse events were compared .


Noninferiority of I-PSS at 1 year was evaluated using a 1-sided test at 5 % level of significance .


The statistical significance of other comparators was assessed at the ( 2-sided ) 5 % level .


Overall 50 and 53 patients were included in the holmium laser enucleation and photoselective vapo-enucleation of the prostate groups , respectively .


Operative time , hospital stay and time to catheter removal were comparable between the groups .


There was significant , comparable improvement in I-PSS and post-void residual urine volume at 1 , 4 and 12 months .


After 4 months prostate size reduction was significantly higher in the holmium laser enucleation of prostate group ( 74.3 % vs 43.1 % , p = 0.001 ) .


At 12 months maximum urine flow rate was significantly higher in the holmium laser enucleation of prostate group ( 26.4 11.5 vs 18.4 7.5 ml per second , p = 0.03 ) .


Re-intervention was needed in 2 and 3 cases in the holmium laser enucleation and photoselective vapo-enucleation of the prostate groups , respectively ( p = 1.0 ) .


Mean estimated cost per holmium laser enucleation of prostate procedure was significantly lower than per photoselective vapo-enucleation of the prostate procedure .


Compared to holmium laser enucleation of prostate , GreenLight XPS laser photoselective vapo-enucleation of the prostate is safe , noninferior and effective in treatment of benign prostatic hyperplasia .


The rate of hyponatremia is higher in hospitalized cancer patients than in hospitalized patients without cancer and is associated with poor clinical outcomes .


The availability of V2 receptor antagonists has been a major breakthrough in the management of hyponatremia , but its efficacy and safety in treating hyponatremia in patients with cancer is not known .


Adult patients with cancer who were admitted to The University of Texas MD Anderson Cancer Center with nonhypovolemic hyponatremia ( 125-130 mmol/L ) were randomized to receive either tolvaptan or placebo in a double-blind , placebo-controlled , adaptive , randomized trial .


Both groups received the standard of care for hyponatremia , except that patients were allowed to drink to thirst .


A preplanned Data Safety Monitoring Board analysis of 30 of 48 randomized patients who completed the study revealed that the primary endpoint of hyponatremia correction was met by 16 of 17 patients who received tolvaptan and by 1 of 13 patients who received placebo ( 94 % vs 8 % ; P < .001 ) , which met the study stopping rule for superiority .


The secondary endpoints between the tolvaptan and placebo groups ( meanstandard deviation ) for length of stay ( 2115 days vs 2615 days , respectively ) and change in the Mini-Mental State Examination score ( -0.351.66 vs 0.312.42 , respectively ) were not significantly different .


No overcorrection of serum sodium ( > 12 mmol/L per day ) was noted in the tolvaptan group , and the main adverse events noted were dry mouth , polydipsia , and polyuria , leading to 13 % study withdrawal .


Although tolvaptan was effective for correcting hyponatremia in patients with cancer , studies with a larger sample size will be required to confirm the current findings , including the outcomes of secondary endpoints .


Remifentanil is a powerful analgesic with fast onset and ultra-short duration of action .


Its context-sensitive half-time is consistently short even after a prolonged infusion .


Remifentanil is effective for providing better postoperative analgesia , but this method is not generally accepted in Japan .


The present study was conducted to document efficacy and safety of low-dose remifentanil infusion in postoperative patients .


Forty patients undergoing abdominal surgery were studied prospectively .


They were randomly assigned to either remifentanil ( 0.02 microg x kg ( -1 ) x min ( -1 ) ) or placebo group .


Postoperatively all patients received continuous epidural anesthesia with lidocaine and IV patient-controlled analgesia with fentanyl .


Flurbiprofen was administered only when no pain relief was achieved .


Visual analogue scale ( VAS ) , requirement of fentanyl and flurbiprofen , and the incidence of remifentanil-related adverse effects ( respiratory depression , nausea , vomiting , pruritus ) were examined at 3 hourly intervals for 12 hours .


There are no statistical differences between two groups in pain scores .


No adverse events including respiratory depression occurred throughout the study in both groups .


Remifentanil infusion at 0.02 microg x kg ( -1 ) x min ( -1 ) can safely be used without any serious adverse events , while it may not be enough for postoperative analgesia .


The best dosage of this drug for postoperative analgesia remains to be elucidated .


To assess the effect of Eutectic Mixture of Local Anaesthetics cream and rattle on soothing the vaccination pain on four-month-infants .


The single blind randomised clinical trial was conducted from May 2012 to February 2013 at a clinic under the Gonabad University of Medical Sciences , Iran , and comprised four-month infants who were selected randomly and divided into three groups .


In one group , 2g of eutectic mixture of local anaesthetics cream was rubbed on the injection spot before administration ; for the other group , the rattle was shaken from 30s to 15s before injection .


The last group consisted of controls .


The infants were filmed after vaccination .


Afterward , a pain questionnaire was filled out by a trained observer .


SPSS 11.5 was used for statistical analysis .


Of the 50 subjects in the study 16 ( 32 % ) each were in the cream and rattle groups , while the rest ( 36 % ) were in the control group .


The severity of the pain before intervention in the control , cream and rattle groups was 2.22 + / - 0.88 , 2.12 + / - 0.95 and 2.25 + / - 1.06 respectively , which were not statistically significant ( p < 0.93 ) .


Likewise , the mean severity of pain at the moment of intervention in the three above groups were 8.67 + / - 0.77 , 7.12 + / - 0.5 and 7.87 + / - 0.96 respectively , which was significantly different ( p < 0.001 ) .


The severity of pain 15seconds after the intervention in the groups was 5.06 + / - 1.51 , 4.87 + / - 1.31 and 4.19 + / - 1.94 respectively , which were not statistically different ( p < 0.27 ) .


The eutectic mixture of local anaesthetics cream and shaking rattle were effective in attenuating pain of vaccination among the infants , but the latter was not as significant as the former .


Oral budesonide 9 mg/day represents first-line treatment of mild-to-moderately active ileocolonic Crohn 's disease .


However , there is no precise recommendation for budesonide dosing due to lack of comparative data .


A once-daily ( OD ) 9 mg dose may improve adherence and thereby efficacy .


An eight-week , double-blind , double-dummy randomised trial compared budesonide 9 mg OD versus 3mg three-times daily ( TID ) in patients with mild-to-moderately active ileocolonic Crohn 's disease .


Primary endpoint was clinical remission defined as CDAI < 150 at week 8 ( last observation carried forward ) .


The final intent-to-treat population comprised 471 patients ( 238 [ 9 mg OD ] , 233 [ 3 mg TID ] ) .


The confirmatory population for the primary endpoint analysis was the interim per protocol population ( n = 377 ; 188 [ 9 mg OD ] , 189 [ 3mg TID ] ) , in which the primary endpoint was statistically non-inferior with budesonide 9 mg OD versus 3 mg TID .


Clinical remission was achieved in 71.3 % versus 75.1 % , a difference of -3.9 % ( 95 % CI [ -14.6 % ; 6.4 % ] ; p = 0.020 for non-inferiority ) .


The mean ( SD ) time to remission was 21.9 ( 13.8 ) days versus 21.4 ( 14.6 ) days with budesonide 9 mg OD versus 3 mg TID , respectively .


In a subpopulation of 122 patients with baseline SES-CD ulcer score 1 , complete mucosal healing occurred in 32.8 % ( 21/64 ) on 9 mg OD and 41.4 % ( 24/58 ) on 3mg TID ; deep remission ( mucosal healing and clinical remission ) was observed in 26.6 % ( 17/64 ) and 32.8 % ( 19/58 ) of patients , respectively .


Treatment-emergent suspected adverse drug reactions were reported in 4.6 % of 9 mg OD and 4.7 % of 3 mg TID patients .


Budesonide at the recommended dose of 9 mg/day can be administered OD without impaired efficacy and safety compared to 3mg TID dosing in mild-to-moderately active Crohn 's disease .


Recent data have supported the use of an early exposure intervention to promote a reduction in acute stress and posttraumatic stress disorder ( PTSD ) symptoms after trauma exposure .


The present study explored a comprehensive predictive model that included history of trauma exposure , dissociation at the time of the trauma and early intervention , and physiological responses ( cortisol and heart rate ) to determine which variables were most indicative of reduced PTSD symptoms for an early intervention or treatment as usual .


Participants ( n = 137 ) were randomly assigned to the early intervention condition ( n = 68 ) or assessment-only condition ( n = 69 ) while receiving care at the emergency department of a Level 1 trauma center .


Follow-up assessments occurred at 4 and 12 weeks posttrauma .


Findings suggested that dissociation at the time of the 1st treatment session was associated with reduced response to the early intervention .


No other predictors were associated with treatment response .


For treatment as usual , cortisol levels at the time of acute care and dissociation at the time of the traumatic event were positively associated with PTSD symptoms .


Dissociation at the time at which treatment starts may indicate poorer response to early intervention for PTSD .


Similarly , dissociation at the time of the event was positively related to PTSD symptoms in those who received treatment as usual .


The arterial blood gas measurement process is a painful and invasive procedure , often uncomfortable for both the patient and the physician .


Because the patient-related factors that determine the difficulty of the process can not be controlled , the physician-related factors and blood gas measurement techniques are a modifiable area of improvement that ought to be considered .


Many hospitals use insulin syringes or syringes washed with heparin for the purpose of blood gas measurement because they do not have blood gas-specific syringes .


In this prospective cross-sectional study , we aimed to compare safety-engineered blood gas syringes and conventional heparinized syringes used during the arterial blood gas extraction process in terms of ease of operation , the physician-patient satisfaction , laboratory appropriateness , and complications .


Our study included patients whose arterial blood gas needed to be measured in the emergency department and who agreed to participate in the study .


Patients were randomly divided into 2 groups .


The arterial blood gas of the patients from the first group was measured by using conventional heparinized syringes , whereas safety-engineered blood gas syringes were used to measure the arterial blood gas of the patients from the second group .


The groups were compared in terms of demographic data , the number of attempts , the physician and patient satisfaction , early and late-term complications , and laboratory appropriateness of the taken sample .


A total of 550 patients were included in our study in a 2-month study period .


There were no significant differences between patients in terms of sex , age , weight , height , body mass index , and wrist circumference .


In addition , the number of attempts ( P = .489 ) , patients ' pain level during the procedure ( P = .145 ) , and the degree of difficulty of the procedure according to the patient ( P = .109 ) and physician ( P = .554 ) were not significantly different between the groups .


After arterial blood gas extraction procedure , 115 patients ( 20.9 % ) developed complications .


In the conventional heparinized syringe group , the complication rate ( n = 69 ; 25.1 % ) was significantly higher compared with the group that used safety-engineered blood gas syringes ( n = 46 ; 16 % ; P = .0211 ) .


Localized pain , which is one of the most common early complications , was more frequent in the conventional heparinized syringe group ( 19.3 % ) .


Complications in women ( P = .003 ) and local pain ( P = .01 ) developed lesser in the second group that used safety-engineered blood gas syringes , and the patient-physician satisfaction was higher in that group , as well .


In the evaluation 48 hours after the procedure , the ratios of infection and local hematoma were higher in the conventional heparinized syringe group ( P = .0213 and P < .0001 ) .


In this study , we did not find any significant differences between the conventional heparinized syringes and safety-engineered blood gas syringes in terms of ease of operation , physician and patient satisfaction , and appropriateness of the taken sample .


However , patients whose arterial blood gas was extracted by using safety-engineered blood gas syringes felt less pain and experienced fewer infections and hematomas at their puncture site .


Transmembrane tumor necrosis factor ( TNF ) - , found on monocytes , is a body 's key defense against cancer .


In patients with type 2 diabetes mellitus ( DM ) and metabolic syndrome , immunity is suppressed , resulting in a high risk of several inflammatory disorders and cancer .


Seventeen patients with type 2 DM and metabolic syndrome were supplemented with either 30 mg of elemental zinc/day or placebo for eight weeks .


Transmembrane TNF -- expressing monocytes and lymphocytes , and plasma TNF - levels were analyzed before and after supplementation .


The present study revealed that zinc supplementation significantly increased the proportion of monocytes expressing transmembrane TNF - .


While the plasma TNF - levels and TNF - expressing lymphocytes were not significantly altered in the zinc-treated and placebo groups , higher proportion of TNF - bound monocytes were observed in the zinc-treated group .


Because functional transmembrane TNF - was shown to be implicated in defense mechanisms , these findings suggest that zinc supplementation may benefit immune response against cancer in patients with DM and metabolic syndrome .


To assess the interobserver agreement in 50 patients with hepatocellular carcinoma ( HCC ) before and 1 month after intra-arterial therapy ( IAT ) using two semi-automated methods and a manual approach for the following functional , volumetric and morphologic parameters : ( 1 ) apparent diffusion coefficient ( ADC ) , ( 2 ) arterial phase enhancement ( AE ) , ( 3 ) portal venous phase enhancement ( VE ) , ( 4 ) tumor volume , and assessment according to ( 5 ) the Response Evaluation Criteria in Solid Tumors ( RECIST ) , and ( 6 ) the European Association for the Study of the Liver ( EASL ) .


This HIPAA-compliant retrospective study had institutional review board approval .


The requirement for patient informed consent was waived .


Tumor ADC , AE , VE , volume , RECIST , and EASL in 50 index lesions was measured by three observers .


Interobserver reproducibility was evaluated using intraclass correlation coefficients ( ICC ) .


P < 0.05 was considered to indicate a significant difference .


Semi-automated volumetric measurements of functional parameters ( ADC , AE , and VE ) before and after IAT as well as change in tumor ADC , AE , or VE had better interobserver agreement ( ICC = 0.830-0 .974 ) compared with manual ROI-based axial measurements ( ICC = 0.157-0 .799 ) .


Semi-automated measurements of tumor volume and size in the axial plane before and after IAT had better interobserver agreement ( ICC = 0.854-0 .996 ) compared with manual size measurements ( ICC = 0.543-0 .596 ) , and interobserver agreement for change in tumor RECIST size was also higher using semi-automated measurements ( ICC = 0.655 ) compared with manual measurements ( ICC = 0.169 ) .


EASL measurements of tumor enhancement in the axial plane before and after IAT ( ( ICC = 0.758-0 .809 ) , and changes in EASL after IAT ( ICC = 0.653 ) had good interobserver agreement .


Semi-automated measurements of functional changes assessed by ADC and VE based on whole-lesion segmentation demonstrated better reproducibility than ROI-based axial measurements , or RECIST or EASL measurements .


Telemedicine is one approach to managing patients with chronic illness .


Several telephone-based monitoring studies of diabetes patients have shown improved glycosylated hemoglobin ( HbA1c ) , blood pressure ( BP ) , and low-density lipoprotein ( LDL ) levels .


The purpose of this study was to evaluate an investigational in-home telemetry device for improving glucose and BP control over 6 months for patients with type 2 diabetes .


The device was used to transmit weekly blood glucose , weight , and BP readings to a diabetes care manager .


We conducted a two-arm , parallel-comparison , single-blind , randomized controlled trial among Kaiser Permanente Northern California members 18-75 years old with type 2 diabetes mellitus and entry HbA1c levels between 7.5 % and 10.0 % .


Participants were randomly assigned to either the telemonitoring arm or the usual care arm .


We observed very small , nonsignificant changes in fructosamine ( telemonitoring , -54.9 mol ; usual care , -59.4 mol ) and systolic BP ( telemonitoring , -6.3 mm Hg ; usual care , -3.2 mm Hg ) from baseline to 6 weeks in both groups .


At 6 months , we observed no significant intergroup differences in change from baseline for HbA1c , fructosamine , or self-efficacy .


However , LDL cholesterol in the telemonitoring arm decreased more than in the usual care arm ( -17.1 mg/dL versus -5.4 mg/dL ; P = 0.045 ) .


Although HbA1c improved significantly over 6 months in both groups , the difference in improvement between the groups was not significant .


This lack of significance may be due to the relatively healthy status of the volunteers in our study and to the high level of care provided by the care managers in the Santa Rosa , CA clinic .


Further study in subgroups of less healthy diabetes patients is recommended .


To investigate the effect of low glycemic index ( LGI ) carbohydrate meal on subjective , metabolic and physiological responses , and endurance performance in the Ramadan fasted state .


During Ramadan , 12 Muslim men , in a randomized and crossover design , ingested for the sahur meal ( i.e. , last meal before commencement of the day 's fast ) , either LGI ( glycemic index = 37 ) or mixed ( CON ; 57 ) meal of equivalent macro-nutrient .


At 12h post-prandial , subjects completed a 60min continuous run .


There were no significant differences between the two meals for ratings in perceived satiety , fullness , appetite and mood states .


During steady-state exercise , there were no significant differences in metabolic and physiological measures .


In the time-trial , distance ran was significantly lower in LGI versus CON meal trial , but with a corresponding lower perceived exertion in the LGI trial .


Compared to CON , ingesting LGI as the sahur meal did not provide any metabolic , physiological or performance benefits during endurance run performed 12h post-prandial in Ramadan fasted state .


Varenicline was developed to aid smoking cessation by reducing smoking reinforcement .


The present study tests this reinforcement-reduction hypothesis among smokers preparing to quit .


After a one-week baseline , treatment-seeking smokers were randomized to receive three weeks of varenicline or placebo ( Weeks 2-4 ) .


During each of the four weeks of the study , smokers completed a hypothetical cigarette purchase task ( CPT ) via handheld devices in their natural environment .


Behavioral economic measures of simulated smoking if cigarettes were free ( demand intensity ) , sensitivity of consumption to increasing price ( elasticity ) , and price at which purchases would drop to 0 ( breakpoint ) were estimated .


The exponential demand equation fit the purchase task data well across subjects and time .


As predicted , demand intensity decreased and sensitivity to price ( elasticity ) increased over time .


However , changes in demand intensity did not differ by treatment group .


Contrary to our hypothesis that varenicline would increase sensitivity to price , the placebo group tended to become more elastic in their purchases during Weeks 2 and 3 ; the groups did not differ in elasticity at Week 4 .


Breakpoint did not vary by group , time , or their interaction .


Simulated smoking demand can be validly assessed in the natural environment of treatment-seeking smokers .


Simulated demand indices of smoking reinforcement diminished as smokers approached their target quit date .


However , there was no evidence that varenicline facilitated these changes over a three-week period , leaving open the mechanisms by which varenicline reduces smoking rate prior to cessation and improves long-term abstinence .


In 2010 , we reported that selenium ( Se ) supplementation during radiation therapy ( RT ) is effective for increasing blood Se levels in Se-deficient cervical and uterine cancer patients , and reduced the number of episodes and severity of RT-induced diarrhea .


In the current study , we examine whether of Se supplementation during adjuvant RT affects long-term survival of these patients .


Former patients were identified and questioned with respect to their health and well-being .


A total of 81 patients were randomized in the initial supplementation study , 39 of whom received Se ( selenium group , SeG ) and 42 of whom served as controls ( control group , CG ) .


When former patients were reidentified after a median follow-up of 70 months ( range = 0-136 ) , the actuarial 10-year disease-free survival rate in the SeG was 80.1 % compared to 83.2 % in the CG ( P = .65 ) , and the actuarial 10-year overall survival rate of patients in the SeG was 55.3 % compared to 42.7 % in the CG ( P = .09 ) .


Our extended follow-up analysis demonstrates that Se supplementation had no influence on the effectiveness of the anticancer irradiation therapy and did not negatively affect patients ' long-term survival .


In view of its positive effects on RT-induced diarrhea , we consider Se supplementation to be a meaningful and beneficial adjuvant treatment in Se-deficient cervical and uterine cancer patients while undergoing pelvic radiation therapy .


A long oral exposure to food and a high-energy density of food have been shown to increase satiety feelings .


The effect of energy density is predominantly caused by an inhibition of gastric emptying .


It is hypothesized that prolonging oral exposure may have an additional effect on this inhibition of gastric emptying .


However , little human data are available to support this hypothesis .


The objective was to assess the effect of the duration of oral exposure to food on gastric emptying rate of gastric loads ( GLs ) low and high in energy density and on satiety feelings .


Twenty-six healthy men [ mean SD age : 22 3 y ; BMI ( in kg/m ( 2 ) ) : 23 1 ] participated in a randomized crossover trial with 4 treatments and a control .


Treatments consisted of either 1 - or 8-min modified sham feeding ( MSF ) of cake , and a GL of either 100 or 700 kcal infused in the stomach via a nasogastric tube ( 500 mL , 62.5 mL/min ) .


The control consisted of no MSF and a GL of 500 mL of water .


Gastric emptying rate was assessed with a ( 13 ) C breath test .


Breath samples and satiety feelings were collected at fixed time points until 90 min after start of the treatment .


Gastric emptying rate and satiety feelings were not affected by duration of MSF ( P 0.27 ) .


However , the 700-kcal GL treatments slowed gastric emptying [ 41 % lower area under the curve ( AUC ) ] and increased satiety feelings ( 22-31 % higher AUC ) compared with the 100-kcal GL treatments ( P < 0.001 ) .


No interaction between MSF duration and energy density of GL was found ( P 0.44 ) .


Higher gastric energy density inhibited gastric emptying and increased satiety feelings in healthy young men .


However , prolonging oral exposure to food did not have an additional effect .


This study provides more insight in satiety regulation .


This trial was registered at trialregister.nl as NTR3601 .


Many recent studies suggest that the kallikrein-kinin system play a protective role in the impairment of vascular smooth muscle cells and vascular endothelial cell .


The study aims to determine whether tissue kallikrein is efficacy for preventing the long-term in-stent restenosis after stenting of symptomatic atherosclerotic stenosis of the middle cerebral artery M1 segment .


This is a Phase II , randomized , single-blinded , controlled trial .


In line with SAMMPRIS stenting indications , patients ( n = 90 ) with the symptomatic the middle cerebral artery M1 segment stenosis 70 % and successfully treated with stent will be enrolled .


Eligible patients will be randomized using computer generated numbers , and allocated to receive tissue kallikrein treatment or not .


Patients in tissue kallikrein treatment group will be prescribed with intravenous infusion of tissue kallikrein ( 0.15 PNAU/d , dissolved in 100 ml saline ) for 7 days after stenting and then oral administration of pancreatic kallikrein enteric-coated tablet ( 240 U , 3/d ) to the end of study .


As the foundation treatment , all the enrolled patients will receive aspirin ( 100 mg/d ) , clopidogrel ( 75 mg/d ) , and atorvastatin ( 20 mg/d ) for the first 6 months and continue with the combination of aspirin and atorvastatin at the previous dosage .


Patients will be evaluated at 1 , 6 and 12 months after stenting .


The primary outcomes are the in-stent restenosis rate , new stroke or aggravation of the previous ischemic stroke ipsilateral to the severe stenotic artery .


Secondary outcomes include stroke of other artery territories , myocardial infarction and vascular death .


Modification of stroke knowledge , exercise and diet habit , smoking cessation and available laboratory data will also be recorded .


As our pilot study , tissue kallikrein would be expected to prevent the long-term in-stent restenosis after stenting of the symptomatic middle cerebral artery dramatically .


Advanced glycation end product ( AGE ) accumulation is thought to be a measure of cumulative metabolic stress that has been reported to independently predict cardiovascular disease in diabetes and renal failure .


The aim of this study was to evaluate the association between AGE accumulation , measured as skin autofluorescence , and the progression of renal disease in pre-dialysis patients with chronic kidney disease ( CKD ) .


Skin autofluorescence was measured noninvasively with an autofluorescence reader at baseline in 449 pre-dialysis patients with CKD .


The primary end point was defined as a doubling of serum creatinine and/or need for dialysis .


Thirty-three patients were lost to follow-up .


Forty six patients reached the primary end point during the follow-up period ( Median 39 months ) .


Kaplan-Meier analysis showed a significantly higher risk of development of the primary end points in patients with skin autofluorescence levels above the optimal cut-off level of 2.31 arbitrary units , derived by receiver operator curve analysis .


Cox regression analysis revealed that skin autofluorescence was an independent predictor of the primary end point , even after adjustment for age , gender , smoking history , diabetes , estimated glomerular filtration rate and proteinuria ( adjusted hazard ratio 2.58 , P = 0.004 ) .


Tissue accumulation of AGEs , measured as skin autofluorescence , is a strong and independent predictor of progression of CKD .


Skin autofluorescence may be useful for risk stratification in this group of patients ; further studies should clarify whether AGE accumulation could be one of the therapeutic targets to improve the prognosis of CKD .


There is no consensus on the optimal perioperative antibiotic prophylaxis regimen for renal transplant recipients .


Some studies have reported that irrigation of the wound at the time of closure without systemic antibiotics may suffice to minimize the risk for surgical site infection ( SSI ) , but many centers still use long-term , multidose regimens in which antibiotics are administered until removal of foreign bodies occur , such as the urethral catheter , drain and central line .


We designed a prospective , randomized , multicenter , controlled trial to compare a single dose versus a multidose regimen of systemic antibiotic prophylaxis in adult , nondiabetic , non-morbidly obese patients undergoing renal transplantation .


The primary endpoint was the incidence of SSI ; the assessment of other infection in the first postoperative month was the secondary endpoint .


Two hundred five patients were enrolled and randomized to receive either a single ( n = 103 ) or multidose antibiotic regimen ( n = 102 ) for prophylaxis .


The incidences of SSI and urinary tract infection were similar in both groups .


As the dramatic increase in antibiotic resistance has mandated the implementation of global programs to optimize the use of antibiotic agents in humans , we believe that the single dose regimen is preferred , at least in nondiabetic , non-morbidly obese , adult renal transplant recipients .


To investigate the relationship between binge eating behavior and weight loss maintenance over a two-year period in adults .


Secondary data analysis using the Keep It Off study , a randomized trial evaluating an intervention to promote weight loss maintenance .


419 men and women ( ages : 20 to 70y ; BMI : 20-44kg / m2 ) who had intentionally lost 10 % of their weight during the previous year .


Body weight was measured and binge eating behavior over the past 6 months was reported at baseline , 12 months and 24 months .


Height was measured at baseline .


Prevalence of binge eating at baseline was 19.4 % ( n = 76 ) .


Prevalence of binge eating at any time point was 30.1 % ( n = 126 ) .


Although rate of weight regain did not differ significantly between those who did or did not report binge eating at baseline , binge eating behavior across the study period ( additive value of presence or absence at each time point ) was significantly associated with different rates of weight regain .


Tailoring weight loss maintenance interventions to address binge eating behavior is warranted given the prevalence and the different rates of weight regain experienced by those reporting this behavior .


To assess whether the increased sensitivity of screening for human papillomavirus ( HPV ) may represent overdiagnosis and to compare the long term duration of protective effect against cervical intraepithelial neoplasia grade 2 or worse ( CIN2 + ) in HPV based and cytology based screening .


13 year follow-up of the Swedescreen randomised controlled trial of primary HPV screening .


Organised cervical screening programme in Sweden .


12,527 women aged 32-38 attending organised screening were enrolled and randomised to HPV and cytology double testing ( intervention arm , n = 6257 ) or to cytology only , with samples frozen for future HPV testing ( control arm , n = 6270 ) .


Cumulative incidence of CIN2 + and CIN3 + ( Kaplan Meier curves ) .


Longitudinal test characteristics were calculated for cytology only , HPV testing only , and cytology and HPV testing combined , adjusting for censoring .


The increased detection of CIN2 + in the intervention arm decreased over time .


After six years , the cumulative incidence of CIN3 + was similar in both trial arms , and after 11 years the cumulative incidence of CIN2 + became similar in both arms .


The longitudinal sensitivity of cytology for CIN2 + in the control arm at three years was similar to the sensitivity of HPV testing in the intervention arm at five years of follow-up : 85.94 % ( 95 % confidence interval 76.85 % to 91.84 % ) v 86.40 % ( 79.21 % to 91.37 % ) .


The sensitivity of HPV screening for CIN3 + after five years was 89.34 % ( 80.10 % to 94.58 % ) and for cytology after three years was 92.02 % ( 80.59 % to 96.97 % ) .


Over long term follow-up , the cumulative incidence of CIN2 + was the same for HPV screening and for cytology , implying that the increased sensitivity of HPV screening for CIN2 + reflects earlier detection rather than overdiagnosis .


The low long term risks of CIN3 + among women who tested negative in HPV screening , support screening intervals of five years for such women .


Clinicaltrials.gov NCT00479375 .


In the US , past month tobacco use is higher among young adults aged 18-25 years than among any other age group .


Neighborhood disorder may be a malleable environmental determinant of tobacco use among young adults ; its correlation with tobacco use is understudied .


The purpose of this study is to examine whether perceived and objectively measured neighborhood factors are associated with tobacco use among young adults in Baltimore City .


This cross-sectional study of predominately African American young adults ( n = 359 ) used logistic regression models via generalized estimating equations ( GEE ) to estimate the association of perceived and objective neighborhood disorder with past month tobacco use , adjusting for race , age , sex , income , and other substance use .


Two measures of perceived neighborhood environment - neighborhood drug involvement , and neighborhood social cohesion - were derived from the Neighborhood Environment Scale ( NES ) .


Objective neighborhood disorder was measured via trained field raters using the Neighborhood Inventory for Environmental Typology ( NIfETy ) instrument .


Sex modified the relationship between perceived neighborhood drug involvement and past month tobacco use , and the association was significant among women only ( aOR = 1.49 ; 95 % CI = 1.19-1 .88 ) .


Perceptions of neighborhood social cohesion ( aOR = 0.97 ; 95 % CI = 0.83-1 .13 ) , and objective neighborhood disorder ( aOR = 1.17 ; 95 % CI = 0.98-1 .38 ) were not significantly associated with past month tobacco use .


Understanding the correlation between perceived and objective neighborhood disorder , and their independent association with tobacco use can potentially lead to environmentally based interventions aimed at reducing tobacco use among young adults who live in urban environments .


Severe perineal tears sustained during childbirth cause significant distress and morbidity amongst women .


The objective of this study was to compare the use of straight scissors for cutting an episiotomy with the use of curved scissors , which are designed to curve away from the anal sphincter .


We used a single-centre , randomised feasibility trial .


The intervention was the use of curved scissors .


Women were recruited during a prenatal visit and randomised in the delivery suite , when it became clear that an episiotomy was required .


The feasibility outcomes were the proportion of women able to be recruited , randomised and followed up .


We also calculated the incidence of obstetric anal sphincter injury when either straight or curved scissors were used to cut an episiotomy .


Other outcomes assessed were pain , length of hospital stay , perineal infection and perineal dehiscence .


Of the 155 patients recruited in the prenatal period , only 20 ( 12.9 % ) were eventually randomised at birth .


The main reasons for the high loss were that women either did not have a vaginal delivery ( 38 , 24.5 % ) , or they did not need an episiotomy ( 72 , 46.5 % ) .


Rates of obstetric anal sphincter injury and other outcomes were similar between groups .


Anal sphincter injury during childbirth remains an important problem .


Although the use of curved scissors provides a theoretical solution , we found that the high attrition rate made feasibility of conducting a suitably powered , randomised trial using the current design untenable .


Alternative strategies have been suggested to make any future study more viable .


To assess the antiviral efficacy of lamivudine ( LAM ) , entecavir ( ETV ) , telbivudine ( LDT ) , and lamivudine and adefovir dipivoxil ( CLA ) combination in previously untreated hepatitis B patients at different time points during a 52-week treatment period .


A total of 164 patients were included in this prospective , open-label , head-to-head study .


Serum levels of alanine transaminase ( ALT ) , hepatitis B virus ( HBV ) DNA , and hepatitis B e antigen ( HBeAg ) were measured at baseline , and at 12 , 24 , and 52 weeks of treatment .


Median reductions in serum HBV DNA levels at 52 weeks ( log 10 copies/mL ) were as follows : LAM , 3.98 ; ETV , 3.89 ; LDT , 4.11 ; and CLA , 3.36 .


The corresponding HBV DNA undetectability rates were 83 % , 96 % , 91 % , and 89 % , respectively .


These two measures showed no significant intergroup differences .


Clinical efficacy appeared related to HBV DNA level reduction after 24 weeks of therapy .


Patients were divided into three groups based on HBV DNA levels at week 24 : Undetectable ( < 10 ( 3 ) copies/mL ) , detectable but < 10 ( 4 ) copies/mL , and > 10 ( 4 ) copies/mL .


Patients with levels below quantitation limit ( QL ) were analyzed at 52 weeks for HBV DNA undetectability rate ( 94 % ) , ALT normalization rate ( 83 % ) , and viral breakthrough rate ( 0 % ) .


The corresponding values in the QL-10 ( 4 ) copies/mL group were 50 % , 75 % , and 13 % , whereas those in the above 10 ( 4 ) copies/mL group were 53 % , 65 % , and 18 % .


There were significant differences at week 52 for HBV DNA levels and viral breakthrough rate between the three groups .


Different nucleos ( t ) ide ( NUC ) analogues tested exhibited no significant differences in effectiveness for Chinese NUC-naive HBV patients during 1-year treatment period .


Chronic renal failure is a progressive and irreversible loss of kidney function , and the hemodialysis ( HD ) is one of the most common modalities in this regard .


Oxidative stresses [ like interleukin-8 ( IL-8 ) and tumor necrosis factor-alpha ( TNF - ) ] and inflammation are the main risk factors associated with cardiovascular diseases and other complications in many organs in hemodialysis patients ; meanwhile , antioxidants like alpha lipoic acid ( ALA ) may reduce the oxidative stress markers and the levels of inflammatory cytokines , so can improve of the patient 's quality of life .


In this randomized clinical trial study , 60 HD patients were randomly categorized in two case and control groups .


Case group received a daily capsule of 600 mg of ALA supplementation for 8 weeks , and the control group received placebo capsules daily .


The serum level of IL-8 and TNF - was measured in both groups before and after the intervention .


There were no significant differences in age , gender , duration of dialysis , and causative factor for dialysis between both groups ( P > 0.05 ) .


The mean of IL-8 and TNF - after the intervention in case group was 26.20 15.34 and 21.25 9.61 , respectively ; the difference between both groups was not statistically significant ( P > 0.05 ) .


Based on the better feeling and other beneficial effects of ALA were found in our study ; we can conclude that it is a beneficial and recommended supplement , especially , for diabetic and dialysis patients .


To compare the efficacy and safety of antithrombotic prophylaxis given for 1 week or 4 weeks in patients undergoing laparoscopic surgery for colorectal cancer .


Extending antithrombotic prophylaxis beyond 1 week reduces the incidence of venous thromboembolism ( VTE ) after open abdominal surgery for cancer .


In consecutive patients who underwent laparoscopic surgery for colorectal cancer , complete compression ultrasonography of the lower limbs was performed after 8 2 days of antithrombotic prophylaxis .


Patients with no evidence of VTE were randomized to short ( heparin withdrawal ) or to extended ( heparin continued for 3 additional weeks ) prophylaxis .


Complete compression ultrasonography was repeated at day 28 2 after surgery by investigators blinded to treatment allocation .


The primary outcome of the study was the composite of symptomatic and ultrasonography-detected VTE at day 28 2 after surgery .


Overall , 301 patients were evaluated for inclusion in the study and 225 were randomized .


VTE occurred in 11 of 113 patients randomized to short ( 9.7 % ) and in none of the 112 patients randomized to extended heparin prophylaxis ( P = 0.001 ) .


The incidence of VTE at 3 months was 9.7 % and 0.9 % in patients randomized to short or to extended heparin prophylaxis , respectively ( relative risk reduction : 91 % , 95 % confidence interval : 30 % -99 % ; P = 0.005 ) .


The rate of bleeding was similar in the 2 treatment groups .


Two patients died during the study period , 1 in each treatment group .


After laparoscopic surgery for colorectal cancer , extended antithrombotic prophylaxis is safe and reduces the risk for VTE as compared with 1-week prophylaxis ( NCT01589146 ) .


We examined the effect of a single apple juice intake on the pharmacokinetics of fexofenadine enantiomers in healthy Japanese subjects .


In a randomized two phase , open-label crossover study , 14 subjects received 60mg of racemic fexofenadine simultaneously with water or apple juice .


For the uptake studies , oocytes expressing organic anion-transporting polypeptide 2B1 ( OATP2B1 ) were incubated with 100M ( R ) - and ( S ) - fexofenadine in the presence or absence of 10 % apple juice .


One-time ingestion of apple juice significantly decreased the area under the plasma concentration-time curve ( AUC0-24 ) for ( R ) - and ( S ) - fexofenadine by 49 and 59 % , respectively , and prolonged the time to reach the maximum plasma concentration ( t max ) of both enantiomers ( P < 0.001 ) .


Although apple juice greatly reduced the amount of ( R ) - and ( S ) - fexofenadine excretion into urine ( Ae0-24 ) by 54 and 58 % , respectively , the renal clearances of both enantiomers were unchanged between the control and apple juice phases .


For in vitro uptake studies , the uptake of both fexofenadine enantiomers into OATP2B1 complementary RNA ( cRNA ) - injected oocytes was significantly higher than that into water-injected oocytes , and this effect was greater for ( R ) - fexofenadine .


In addition , apple juice significantly decreased the uptake of both enantiomers into OATP2B1 cRNA-injected oocytes .


These results suggest that OATP2B1 plays an important role in the stereoselective pharmacokinetics of fexofenadine and that one-time apple juice ingestion probably inhibits intestinal OATP2B1-mediated transport of both enantiomers .


In addition , this study demonstrates that the OATP2B1 inhibition effect does not require repeated ingestion or a large volume of apple juice .


The introduction of all-trans-retinoic acid ( ATRA ) has significantly improved outcomes for acute promyelocytic leukemia ( APL ) , although a subset of patients still suffer relapse .


The purpose of this study was to evaluate the role of maintenance therapy with the synthetic retinoid tamibarotene in APL .


Patients with newly diagnosed APL in molecular remission at the end of consolidation therapy were randomly assigned to receive ATRA or tamibarotene , both orally , for 14 days every 3 months for up to 2 years .


A total of 347 patients were enrolled .


Of the 344 eligible patients , 319 ( 93 % ) achieved complete remission .


After completing three courses of consolidation therapy , 269 patients underwent maintenance random assignment .


The relapse-free survival ( RFS ) rate at 4 years was 84 % for the ATRA arm and 91 % for the tamibarotene arm ( hazard ratio [ HR ] , 0.54 ; 95 % CI , 0.26 to 1.13 ) .


When the analysis was restricted to 52 high-risk patients with an initial WBC count 10.0 10 ( 9 ) / L , the intergroup difference was statistically significant , with 4-year RFS rates of 58 % for the ATRA arm and 87 % for the tamibarotene arm ( HR , 0.26 ; 95 % CI , 0.07 to 0.95 ) .


For patients with non-high-risk disease , the HR was 0.82 ( 95 % CI , 0.32 to 2.01 ) .


The test for interaction between treatment effects and these subgroups resulted in P = .075 .


Both treatments were generally well tolerated .


In this trial , no difference was detected between ATRA and tamibarotene for maintenance therapy .


In an exploratory analysis , there was a suggestion of improved efficacy of tamibarotene in high-risk patients , but this requires further study .


Medical students often lack training in complex geriatric medical decision making .


We therefore developed the serious game , GeriatriX , for training medical decision making with weighing patient preferences , and appropriateness and costs of medical care .


We hypothesized that education with GeriatriX would improve the ability to deal with geriatric decision making and also increase cost consciousness .


A randomized , controlled pre-post measurement design .


Fifth-year medical students .


Playing the serious game GeriatriX as an additive to usual geriatric education .


We evaluated the effects of playing GeriatriX on self-perceived knowledge of geriatric themes and the self-perceived competence of weighing patient preferences , appropriateness , and costs of medical care in geriatric decision making .


Cost consciousness was evaluated with a postmeasurement to estimate costs of different diagnostic tests .


There was a large positive increase in the self-perceived competence of weighing patient preferences , appropriateness , and costs of medical care in the intervention group ( n = 71 ) ( effect sizes of 0.7 , 1.0 , and 1.2 , respectively ) , which was significantly better for the last 2 aspects than in the control group ( n = 63 ) .


The intervention group performed better on cost consciousness .


Although the self-perceived knowledge increased substantially on some geriatric topics , this improvement was not different between the intervention and control groups .


After playing the serious game , GeriatriX , medical students have a higher self-perceived competence in weighing patient preferences , appropriateness , and costs of medical care in complex geriatric medical decision making .


Playing GeriatriX also resulted in better cost consciousness .


We therefore encourage wider use of GeriatriX to teach geriatrics in medical curricula and its further research on educational and health care outcomes .


To evaluate the mid-to long-term results of a randomized controlled trial of single-bundle ( SB ) versus double-bundle ( DB ) anterior cruciate ligament ( ACL ) reconstruction using a semitendinosus tendon .


Seventy-eight patients who underwent primary ACL reconstruction with an autologous semitendinosus tendon were prospectively randomized into 2 groups : SB reconstruction ( n = 39 ) and DB reconstruction ( n = 39 ) .


In both groups , grafts were fixed at 30 of flexion with a total tension of 80 N.


The following evaluation methods were used : clinical examination , KT-1000 arthrometer ( MEDmetric , San Diego , CA ) measurement , muscle strength , Tegner activity score , Lysholm score , subjective rating scale regarding patient satisfaction and sports performance level , graft retear , contralateral ACL tear , and additional meniscus surgery .


Fifty-three patients ( 25 in SB group and 28 in DB group ) who were followed up for a minimum of 3 years ( mean , 69 months ; range , 36 to 140 months ) were evaluated .


Preoperatively , there were no differences between the groups .


Postoperatively , the Lachman and pivot-shift test results were better in the DB group ( P = .024 and P < .0001 , respectively ) .


KT measurements were better in the DB group ( mean , 1.4 mm v 2.7 mm ; P = .0023 ) .


The Tegner score was also better in the DB group ( P = .033 ) .


There were no significant differences in range of motion , muscle strength , Lysholm score , subjective rating scale , graft retear , and secondary meniscal tear .


In ACL reconstruction using the transtibial approach , DB reconstruction was significantly better than SB reconstruction regarding anterior and rotational stability during the 3 - to 12-year follow-up .


The results of KT measurements and the Lachman and pivot-shift tests were significantly better in the DB group , whereas there was no difference in the anterior drawer test results .


The Tegner score was also better in the DB group ; however , there were no differences in the other subjective findings .


Level II , lesser-quality prospective randomized trial .


The study aim is to investigate synergistic effects of cilostazol and probucol combination therapy on coronary plaque volume and composition .


A total of 119 patients undergoing coronary stenting were treated with probucol and cilostazol combination therapy ( group ) or with cilostazol monotherapy ( group ) in a double-blind , randomized multicenter trial , and evaluated by virtual histology intravascular ultrasound ( VH-IVUS ) at baseline and 9-month follow-up for changes in coronary plaque volume and composition at an index intermediate lesion with luminal narrowing 30 % and 70 % and for neointimal hyperplasia at the stented segment .


In all patients simvastatin 20 mg was started with enrollment .


Qualifying VH-IVUS data from 91 patients were included in the final analysis .


There were no significant differences between group and with respect to the primary endpoint , nominal change in normalized total atheroma volume ( TAV ) of the index intermediate coronary lesion ( -12.617.7 vs. -14.220.2 mm ( 3 ) , p = 0.691 ) , or plaque composition .


Plaque regression was observed in more than 70 % of patients in both groups .


Diabetes was the only significant independent determinant of changes in TAV ( = 0.22 , p = 0.037 ) .


There were greater decreases in total cholesterol ( -51.833.0 vs. -25.439.1 mg/dL , p0 .001 ) and LDL ( -33.530.5 vs. -20.330.8 mg/dL , p = 0.044 ) levels in group than in group .


However , HDL cholesterol ( -11.28.5 vs. 2.77.7 mg/dL , p0 .001 ) and apoA1 ( -18.221.4 vs. 10.016.5 mg/dL , p0 .001 ) levels were also significantly decreased in group compared with group .


There were no significant differences in changes in plaque volume or composition between the cilostazol and probucol combination therapy and cilostazol monotherapy group despite different impacts of the treatments on lipid biomarkers .


Aspiration pneumonia is a leading cause of death in people with Parkinson disease ( PD ) .


The pathogenesis of these infections is largely attributed to the presence of dysphagia with silent aspiration or aspiration without an appropriate cough response .


The goal of this study was to test reflex cough thresholds and associated urge-to-cough ( UTC ) ratings in participants with PD with and without dysphagia .


Twenty participants with PD were recruited for this study .


They completed a capsaicin challenge with three randomized blocks of 0 , 50 , 100 , and 200 M capsaicin and rated their UTC by modified Borg scale .


The concentration of capsaicin that elicited a two-cough response , total number of coughs , and sensitivity of the participant to the cough stimulus ( UTC ) were measured .


The dysphagia severity of participants with PD was identified with the penetration-aspiration scale .


Most participants with PD did not have a consistent two-cough response to 200 M capsaicin .


UTC ratings and total number of coughs produced at 200 M capsaicin were significantly influenced by dysphagia severity but not by general PD severity , age , or disease duration .


Increasing levels of dysphagia severity resulted in significantly blunted cough sensitivity ( UTC ) .


UTC ratings may be important in understanding the mechanism underlying morbidity related to aspiration pneumonia in people with PD and dysphagia .


Further understanding of decreased UTC in people with PD and dysphagia will be essential for the development of strategies and treatments to address airway protection deficits in this population .


Fluoroquinolones are the most commonly used group of antimicrobials for the treatment of enteric fever , but no direct comparison between two fluoroquinolones has been performed in a large randomised trial .


An open-label randomized trial was conducted to investigate whether gatifloxacin is more effective than ofloxacin in the treatment of uncomplicated enteric fever caused by nalidixic acid-resistant Salmonella enterica serovars Typhi and Paratyphi A.


Adults and children clinically diagnosed with uncomplicated enteric fever were enrolled in the study to receive gatifloxacin ( 10 mg/kg/day ) in a single dose or ofloxacin ( 20 mg/kg/day ) in two divided doses for 7 days .


Patients were followed for six months .


The primary outcome was treatment failure in patients infected with nalidixic acid resistant isolates .


627 patients with a median age of 17 ( IQR 9-23 ) years were randomised .


Of the 218 patients with culture confirmed enteric fever , 170 patients were infected with nalidixic acid-resistant isolates .


In the ofloxacin group , 6 out of 83 patients had treatment failure compared to 5 out of 87 in the gatifloxacin group ( hazard ratio [ HR ] of time to failure 0.81 , 95 % CI 0.25 to 2.65 , p = 0.73 ) .


The median time to fever clearance was 4.70 days ( IQR 2.98-5 .90 ) in the ofloxacin group versus 3.31 days ( IQR 2.29-4 .75 ) in the gatifloxacin group ( HR = 1.59 , 95 % CI 1.16 to 2.18 , p = 0.004 ) .


The results in all blood culture-confirmed patients and all randomized patients were comparable .


Gatifloxacin was not superior to ofloxacin in preventing failure , but use of gatifloxacin did result in more prompt fever clearance time compared to ofloxacin .


ISRCTN 63006567 ( www.controlled-trials.com ) .


Intimate partner violence ( IPV ) and its associated negative mental health consequences are significant for women in New Zealand and internationally .


One of the most widely recommended interventions is safety planning .


However , few women experiencing violence access specialist services for safety planning .


A safety decision aid , weighing the dangers of leaving or staying in an abusive relationship , gives women the opportunity to prioritise , plan and take action to increase safety for themselves and their children .


This randomised controlled trial is testing the effectiveness of an innovative , interactive web-based safety decision aid .


The trial is an international collaborative concurrent replication of a USA trial ( IRIS study NCT01312103 ) , regionalised for the Aotearoa New Zealand culture and offers fully automated online trial recruitment , eligibility screening and consent .


In a fully automated web-based trial ( isafe ) 340 abused women will be randomly assigned in equal numbers to a safety decision aid intervention or usual safety planning control website .


Intervention components include : ( a ) safety priority setting , ( b ) danger assessment and ( c ) an individually tailored safety action plan .


Self-reported outcome measures are collected at baseline and 3 , 6 , and 12-months post-baseline .


Primary outcomes are depression ( measured by Center for Epidemiologic Studies Depression Scale , Revised ) and IPV exposure ( measured by Severity Violence Against Women Scale ) at 12 months post-baseline .


Secondary outcomes include PTSD , psychological abuse , decisional conflict , safety behaviors and danger in the relationship .


This trial will provide much-needed information on the potential relationships among safety planning , improved mental health , reduced violence as well as decreased decisional conflict related to safety in the abusive relationship .


The novel web-based safety decision aid intervention may provide a cost-effective , easily accessed safety-planning resource that can be translated into clinical and community practice by multiple health disciplines and advocates .


The trial will also provide information about how women in abusive relationships safely access safety information and resources through the Internet .


Finally , the trial will inform other research teams on the feasibility and acceptability of fully automated recruitment , eligibility screening , consent and retention procedures .


Trial registered on 03 July 2012 on the Australian New Zealand Clinical Trials Registry ACTRN12612000708853 .


Cell-based strategies that combine in vitro - expanded autologous chondrocytes with matrix scaffolds are currently preferred for full-thickness cartilage lesions of the knee 2cm ( 2 ) .


Although this approach is reasonable , continuing advances in the field of cartilage repair will further expand the options available to improve outcomes .


In the present clinical study , we compared the outcomes of matrix-induced autologous mesenchymal stem cell implantation ( m-AMI ) with matrix-induced autologous chondrocyte implantation ( m-ACI ) for the treatment of isolated chondral defects of the knee .


Prospective , single-site , randomized , single-blind pilot study .


Fourteen patients with isolated full-thickness chondral lesions of the knee > 2cm ( 2 ) were randomized into two treatment groups : m-AMI and m-ACI .


Outcomes were assessed pre-operatively and 3 , 6 , 12 and 24months post-operatively .


Clinical evaluations revealed that improvement from pre-operation to 24months post-operation occurred in both groups ( p < 0.05 ) .


At all follow-up intervals , m-AMI demonstrated significantly better functional outcomes ( motion deficit and straight leg raise strength ) than did m-ACI ( p < 0.05 ) .


At all follow-up intervals , m-AMI demonstrated significantly better subjective sub-scale scores for pain , symptoms , activities of daily living and sport and recreation of the knee injury and osteoarthritis outcome score ( KOOS ) than did m-ACI ( p < 0.05 ) .


Additionally , m-AMI demonstrated significantly better ( p < 0.05 ) scores than m-ACI for the quality of life sub-scale of the KOOS and visual analog scale ( VAS ) severity at the 6-month follow-up .


The Tegner activity score and VAS frequency were not significantly different between the two groups .


Graft failure was not observed on magnetic resonance imaging at the 24-month follow-up .


m-AMI and m-ACI demonstrated very good-to-excellent and good-to-very good infill , respectively , with no adverse effects from the implant , regardless of the treatment .


For the treatment of isolated full-thickness chondral lesion of the knee , m-AMI can be used effectively and may potentially accelerate recovery .


A larger patient cohort and follow-up supported by histological analyses are necessary to determine long-term outcomes .


To evaluate the change in drusen volume following treatment with eculizumab , a systemic inhibitor of complement component 5 .


Single-center , prospective , randomized , double-masked clinical trial .


Patients were randomized 2:1 to receive intravenous eculizumab or placebo over 26 weeks .


decrease in drusen volume of at least 50 % at 26-week follow-up .


Mean drusen cube root volumes were 0.49 mm and 0.47 mm ( P = .64 ) at baseline and 0.51 mm and 0.42 mm ( P = .17 ) at 26 weeks in the eculizumab and placebo groups , respectively .


In the placebo group , one eye had a decrease in drusen volume of at least 50 % and two eyes developed neovascularization through 26 weeks .


Systemic complement inhibition with eculizumab did not significantly reduce drusen volume .


Drusen growth was dependent on the number of complement at-risk alleles .


Future trials should consider the use of a composite clinical trial endpoint in which efficacy is defined by the treatments ability to prevent drusen growth , neovascularization , and the formation of geographic atrophy over 1 year .


Left atrial ( LA ) strain is a sensitive measure of LA mechanics .


However , its relationship with rhythm outcomes after catheter ablation in patients with atrial fibrillation ( AF ) is not well established .


The aim of this study was to evaluate whether baseline LA global longitudinal strain ( LA ) predicts rhythm outcomes in patients who undergo catheter ablation for AF .


In 256 patients with AF ( paroxysmal , 204 ; persistent , 52 ) , comprehensive echocardiography was performed with assessment of LA by using Velocity Vector Imaging to calculate average strain values from apical four - and two-chamber views before ablation ( median , 41 days ; interquartile range , 1-95 days ) .


After a median of 8.0 months ( interquartile range , 4.0-23 .3 months ) of follow-up , 149 patients ( 58 % ) had maintained sinus rhythm and 107 patients ( 42 % ) had recurrence of AF .


In our study cohort ( mean age 5911years ; mean left ventricular ejection fraction , 5810 % ) , impaired total LA ( LAtotal ) was associated with greater left ventricular mass index ( r = -0.245 , P < .001 ) and worsening left ventricular diastolic function ( ratio of transmitral flow peak early diastolic velocity to peak early diastolic velocity of the mitral annulus : r = -0.357 , P < .001 ; maximal LA volume index : r = -0.393 , P < .001 ) .


Patients with LAtotal < 23.2 % showed a higher incidence of AF recurrence compared with patients with LAtotal 23.2 % ( log-rank P < .001 ) .


In multivariate Cox proportional-hazards analysis , LAtotal was independently related to rhythm outcomes ( hazard ratio , 0.944 ; 95 % confidence interval , 0.915-0 .975 ; P < .001 ) after AF ablation .


Moreover , LAtotal provided incremental predictive value for rhythm outcomes over clinical features ( increment in global ( 2 ) = 14.63 , P < .001 ) .


In patients with AF , baseline LAtotal was associated with rhythm outcome after catheter ablation .


Antimicrobial drugs are frequently prescribed to children for respiratory tract infections such as otitis , tonsillitis , sinusitis , and pneumonia .


We assessed the effect of the ten-valent pneumococcal Haemophilus influenzae protein D conjugate vaccine ( PHiD-CV10 ; GlaxoSmithKline ) on antimicrobial purchases .


In this nationwide phase 3-4 cluster-randomised , double-blind trial , children younger than 19 months were randomly assigned to receive PHiD-CV10 in 52 of 78 clusters or hepatitis B or A vaccine as control in 26 clusters according to three plus one or two plus one schedules ( infants younger than 7 months ) or catch-up schedules ( children aged 7-18 months ) .


The main objective for the antimicrobial treatment outcome was to assess vaccine effectiveness against outpatient prescriptions of antimicrobial drugs recommended by national treatment guidelines for acute otitis media in Finland in children who received at least one dose of study vaccine before 7 months of age .


Masked follow-up lasted from the date of first vaccination ( from Feb 18 , 2009 , through Oct 5 , 2010 ) to Dec 31 , 2011 .


We obtained data on all purchased antimicrobial prescriptions through the benefits register of the Social Insurance Institution of Finland .


This and the nested acute otitis media trial are registered at ClinicalTrials.gov , numbers NCT00861380 and NCT00839254 .


More than 47,000 children were enrolled .


In 30,527 infants younger than 7 months at enrollment , 98,436 outpatient antimicrobial purchases were reported with incidence of 1.69 per person-year in the control clusters .


Analysis of the main objective included 91 % of all antimicrobial purchases : 31,982 in the control and 57,964 in the PHiD-CV10 clusters .


Vaccine effectiveness was 8 % ( 95 % CI 1-14 ) and the incidence rate difference 0.12 per person-year corresponding to the number needed to vaccinate of five ( 95 % CI 3-67 ) to prevent one purchase during the 2 year follow-up for combined PHiD-CV10 three plus one and two plus one infant schedules .


The vaccine effectiveness was identical for the two infant schedules .


In the catch-up schedules , the vaccine effectiveness was 3 % ( 95 % CI -4 to 10 ) .


Despite low relative rate reductions the absolute rate reductions were substantial because of the high incidence of the outcome .


This reduction would lead to over 12,000 fewer antimicrobial purchases per year in children younger than 24 months in Finland ( birth cohort of 60,000 children ) .


To investigate the clinical efficacy of Shuganyiyang Capsule combined with conventional Western medicine ( tamsulosin hydrochloride sustained release tablets + prostat tablets ) for the treatment of type III prostatitis complicated by erectile dysfunction ( ED ) .


Eighty patients with type III prostatitis complicated by ED were equally randomized to an experimental and a control group , the former treated with Shuganyiyang Capsule combined with tamsulosin hydrochloride sustained release tablets and prostat tablets , while the latter with tamsulosin hydrochloride and prostat only , both for 8 weeks .


Then the prostatitis symptoms , erectile function and psychological conditions of the patients were evaluated using NIH-CPSI , IIEF-5 , and hospital anxiety and depression scale ( HADA and HADD ) respectively .


The rates of recovery , excellence , effectiveness and ineffectiveness were calculated .


The scores on NIH-CPSI , IIEF-5 , HADA and HADD obtained at 4 and 8 weeks after treatment showed statistically significant differences between the two time points as well as from the baseline ( P < 0.01 ) .


At 8 weeks , the scores on NIH-CPSI , IIEF-5 , HADA and HADD were 6.83 + / - 4.96 , 21.03 + / - 2.54 , 6.05 + / - 1.62 , and 5.35 + / - 3.30 in the experimental group , as compared with 7.55 + / - 4.89 , 17.68 + / - 4.15 , 6.88 + / - 2.45 , and 7.85 + / - 3.77 in the control ( P < 0.05 ) .


The rate of effectiveness was significantly higher in the experimental than in the control group ( 90 % [ 36/40 ] vs 70 % [ 28/40 ] , P < 0.05 ) .


Shuganyiyang Capsule combined with conventional Western medicine , such as alpha blockers and galenica , produces definite effect on chronic prostatitis complicated by ED , improves the psychological conditions of the patient , and enhances the therapeutic efficiency of chronic prostatits .


The purpose was to evaluate the effectiveness of Staying Healthy-Asthma Responsible & Prepared , an academic asthma health education and counseling program , on fostering the use of effective asthma self-care behaviors .


This was a phase III , two-group , cluster randomized , single-blinded , longitudinal design-guided study .


Caregivers of 205 fourth - and fifth-grade students completed the asthma health behaviors survey at preintervention , and 1 , 12 , and 24 months postintervention .


Analysis involved multilevel modeling .


All students demonstrated improvement in episode management , risk reduction/prevention , and health promotion behaviors ; Staying Healthy-Asthma Responsible & Prepared students demonstrated increased improvement in episode management and risk reduction/prevention behaviors .


Working with schoolteachers , nurses can improve the use of effective asthma self-care behaviors .


Macrolide resistance is an increasing problem ; there is therefore debate about when to implement maintenance treatment with macrolides in patients with chronic obstructive pulmonary disease ( COPD ) .


We aimed to investigate whether patients with COPD who had received treatment for three or more exacerbations in the previous year would have a decrease in exacerbation rate when maintenance treatment with azithromycin was added to standard care .


We did a randomised , double-blind , placebo-controlled , single-centre trial in The Netherlands between May 19 , 2010 , and June 18 , 2013 .


Patients ( 18 years ) with a diagnosis of COPD who had received treatment for three or more exacerbations in the previous year were randomly assigned , via a computer-generated randomisation sequence with permuted block sizes of ten , to receive 500 mg azithromycin or placebo three times a week for 12 months .


Randomisation was stratified by use of long-term , low-dose prednisolone ( 10 mg daily ) .


Patients and investigators were masked to group allocation .


The primary endpoint was rate of exacerbations of COPD in the year of treatment .


Analysis was by intention to treat .


This study is registered with ClinicalTrials.gov , number NCT00985244 .


We randomly assigned 92 patients to the azithromycin group ( n = 47 ) or the placebo group ( n = 45 ) , of whom 41 ( 87 % ) versus 36 ( 80 % ) completed the study .


We recorded 84 exacerbations in patients in the azithromycin group compared with 129 in those in the placebo group .


The unadjusted exacerbation rate per patient per year was 194 ( 95 % CI 150-252 ) for the azithromycin group and 322 ( 262-397 ) for the placebo group .


After adjustment , azithromycin resulted in a significant reduction in the exacerbation rate versus placebo ( 058 , 95 % CI 042-079 ; p = 0001 ) .


Three ( 6 % ) patients in the azithromycin group reported serious adverse events compared with five ( 11 % ) in the placebo group .


During follow-up , the most common adverse event was diarrhoea in the azithromycin group ( nine [ 19 % ] patients vs one [ 2 % ] in the placebo group ; p = 0015 ) .


Maintenance treatment with azithromycin significantly decreased the exacerbation rate compared with placebo and should therefore be considered for use in patients with COPD who have the frequent exacerbator phenotype and are refractory to standard care .


SoLong Trust .


To investigate the effect of ulinastatin , a urinary trypsin inhibitor , on the postoperative liver function in patients who have received bilateral total knee arthroplasty ( TKA ) under pneumatic tourniquet .


Totally 40 patients who were scheduled to receive bilateral TKA under thigh tourniquet were randomly assigned into trial group ( U group , receiving intravenous ulinastatin ) and control group ( C group , receiving natural saline ) .


All patients received the same general anesthesia and postoperative analgesia .


The plasma concentrations of alanine transaminase ( ALT ) , total bilirubin ( TBil ) , and direct bilirubin ( DBil ) were recorded and compared preoperatively and 4 , 24 , 48 , and 72 hours after the surgery .


The demographic data were not significantly different between these two groups ( P > 0.05 ) .


The ALT was not significantly changed after the surgery in the C group ( P > 0.05 ) but was significantly decreased 48 hours ( P = 0.002 ) and 72 hours ( P = 0.001 ) after the surgery in the U group .


TBil and DBil were significantly increased 48 hours ( P = 0.012 , P = 0.000 ) and 72 hours ( P = 0.000 , P = 0.000 ) after the surgery in C group , while only that at 48 hours ( P = 0.010 , P = 0.038 ) was significantly increased in the U group .


ALT 4 hours ( P = 0.026 ) , 48 hours ( P = 0.013 ) , 72 hours ( P = 0.004 ) after the surgery were significantly lower in the U group than those in C group .


TBil at the 72 hours postoperatively in U group was significantly lower than that in C group ( P = 0.036 ) .


DBil was not significantly different between C group and U group at all time points ( all P > 0.05 ) .


The application of ulinastatin in bilateral TKA can protect postoperative liver function .


Chinese monogamous women may contract sexually transmitted diseases ( STD ) from their sole male sex partner , but these women do not have high self-efficacy in negotiating about condom use with their regular sex partners .


We aim to investigate the relative efficacy of a theory-based and clinic-based cognitive behavioral intervention versus a control intervention in increasing prevalence of condom use with their male sex partner among Chinese monogamous female sexually transmitted disease patients .


A randomized controlled trial ( RCT ) was conducted .


Participants were randomly allocated into the intervention group ( n = 88 ) or the control group ( n = 88 ) .


All participants were phone interviewed at baseline and at 2 and 3 months after completion of the baseline survey .


The three-session group intervention was based on the information-motivation-behavioral skills ( IMB ) model .


Participants of the control group were provided with educational pamphlets .


The primary outcome was consistent condom use in the last month .


Relative risks were calculated , and multiple logistic regression models were fit .


As compared to the control group , the intervention group reported higher prevalence of consistent condom use with the sole male sex partner in the last month at month 2 ( 75.3 versus 59.8 % , RR = 1.26 , 95 % CI = 1.01 , 1.57 ) and month 3 ( 77.8 versus 54.6 % , RR = 1.42 , 95 % CI = 1.13 , 1.80 ) , whilst the baseline between-group difference was statistically non-significant .


Some other secondary outcomes such as `` intention to request condom use in the next month even if the sexual partner dislikes using condoms '' were also statistically significant .


Furthermore , the majority ( 94 % ) of the intervention group members were satisfied with the intervention .


The theory-based intervention is potentially efficacious , but the follow-up period was relatively short .


Large-scale randomized clinical trials and subsequent translational research are greatly warranted in the future .


This study aimed to examine the acute effect of caffeine on exercise capacity , exercise-related fatigue , and functional performance in prostate cancer survivors .


In this randomized , placebo-controlled , double-blind crossover study , 30 prostate cancer survivors ( age , 70.3 7.7 yr ; body mass , 80.5 13.0 kg ; mean SD ) consumed 6.04 0.16 mgkg ( -1 ) of anhydrous caffeine or a placebo 1 h before completing a battery of exercise capacity and functional performance tests .


Testing sessions were separated by 3-4 wk .


Immediate fatigue and perceived exertion were measured directly pre - and postexercise at both testing sessions .


Caffeine increased exercise capacity by 7.93 s ( +3.0 % ; P = 0.010 ) ; however , postexercise fatigue and perception of exertion were comparable with the placebo session ( P = 0.632 and P = 0.902 , respectively ) .


Increases in isometric grip strength trended toward significance in both dominant ( +2.9 % ; P = 0.053 ) and nondominant ( +2.1 % ; P = 0.061 ) hands in the caffeine trial compared with placebo .


Caffeine ingestion did not result in improvements in performance for any of the remaining functional measures , including the timed up-and-go test , repeated chair stands , 6-m fast walk , and 6-m backward tandem walk .


Systolic blood pressure and HR were significantly increased ( P = 0.006 and P = 0.040 , respectively ) upon completion of the testing battery when compared with placebo .