The possibility that greater androgen suppression in patients with localized high-risk PCa will result in improved clinical outcomes makes paramount the reassessment of neoadjuvant ADT with more robust androgen suppression .


A neoadjuvant randomized phase II trial of LHRHa with AA was conducted in patients with localized high-risk PCa ( N = 58 ) .


For the first 12 weeks , patients were randomly assigned to LHRHa versus LHRHa plus AA .


After a research prostate biopsy , all patients received 12 additional weeks of LHRHa plus AA followed by prostatectomy .


The levels of intraprostatic androgens from 12-week prostate biopsies , including the primary end point ( dihydrotestosterone/testosterone ) , were significantly lower ( dehydroepiandrosterone , ( 4 ) - androstene-3 ,17 - dione , dihydrotestosterone , all P < .001 ; testosterone , P < .05 ) with LHRHa plus AA compared with LHRHa alone .


Prostatectomy pathologic staging demonstrated a low incidence of complete responses and minimal residual disease , with residual T3 - or lymph node-positive disease in the majority .


LHRHa plus AA treatment suppresses tissue androgens more effectively than LHRHa alone .


Intensive intratumoral androgen suppression with LHRHa plus AA before prostatectomy for localized high-risk PCa may reduce tumor burden .


We evaluated the analgesic effect of ropivacaine infiltration into the surgical wound after caesarean section .


In a double-blind trial , 67 patients who were scheduled for caesarean section under spinal anaesthesia were randomly assigned to receive either 0.75 % ropivacaine or placebo ( NaCl 0.9 % ) through a multi-orifice catheter that was placed into the surgical wound , between the muscle fascia and the subcutaneous tissue .


The study drug was administered as a bolus of 10ml at the end of the operation , followed by an infusion at 2ml/h for 48h .


All patients were also given paracetamol and ibuprofen .


The primary outcome was the total amount of rescue oxycodone needed during the first 48h post-operatively .


Secondary outcomes included pain and patient satisfaction scores .


Analyses were according to intention to treat .


The mean ( standard deviation ) amount of oxycodone administered during the first 48h was 47.520.9 mg in the ropivacaine group and 57.829.4 mg in the placebo group ( 95 % confidence interval for the difference between means , -22.8 -2.2 mg ; P = 0.10 ) .


There were no differences between the groups in pain scores or in patient satisfaction scores .


Continuous wound infiltration with ropivacaine did not decrease the need for opioids and had no impact on pain scores or patient satisfaction after caesarean section .


Botulinum toxin type A is a first-line treatment for post-stroke focal spasticity , and the accuracy in delivering the toxin to the target muscles may influence the treatment outcome .


Our aim was to compare the reduction of spasticity and the related finger position at rest improvement in post-stroke patients treated with botulinum toxin type A in upper limb muscles using ultrasound guidance and manual needle placement .


In a randomized clinical trial , two groups of 15 stroke patients were treated with botulinum toxin type A injections in the wrist and finger flexor muscles of the affected upper limb using ultrasound guidance or manual needle placement .


The Modified Ashworth Scale and the finger position at rest were measured at baseline and one month after toxin injections .


After one month of follow-up from toxin injections , the Modified Ashworth Scale and finger position at rest significantly improved in both treatment groups , although these clinical outcomes were significantly better in patients treated under ultrasound guidance than in patients injected using manual needle placement .


Ultrasound guidance for botulinum toxin type A injections could improve clinical outcome measures better than manual needle placement in post-stroke patients with spasticity .


This study was designed to investigate the topical anesthetic efficacy of four different solutions including lidocaine spray , bupivacaine , ropivacaine , and prilocaine used in patients undergoing transnasal fiberoptic nasopharyngolaryngoscopic examination ( TFL ) .


The study included 200 patients who underwent anterior rhinoscopy and TFL examination as a part of routine otolaryngological evaluation in our outpatient clinics .


Of these , 111 were female and 89 were male patients .


The mean age of the patients was 32 8 years ( aged between 19 and 55 years ) .


The patients were randomly divided into five groups .


Five groups received one of the local anesthetics studied in our trial ( 10 % lidocaine , 0.5 % ropivacaine , 0.25 % bupivacaine , 2 % prilocaine , and saline solution ) in each right side of the nose for 10 minutes before TFL .


Each separate examination was performed on the right side of the nasal cavity .


After the examination , the patients were asked to note the intensity of the pain that they have experienced during the TFL , by using a 100-mm visual analog scale ( VAS ) .


The mean VAS scores were 2.08 ( SD , 0.62 ) in the lidocaine group , 2.21 ( SD , 0.66 ) in the prilocaine group , 3.92 ( SD , 0.58 ) in the ropivacaine group , 4.15 ( SD , 0.64 ) in the bupivacaine group , and 6.35 ( SD , 0.65 ) in the saline solution group .


The lidocaine and prilocaine groups had significantly better VAS scores versus ropivacaine , bupivacaine , and saline solution groups ( p < 0.05 ) .


To provide ideal examination comfort and optimum patient tolerability during TFL evaluation of upper respiratory airway topical lidocaine and prilocaine applications were found to be more efficacious and effective medication for anesthesia of the intranasal mucosa compared with bupivacaine and ropivacaine solutions .


N ( 1 ) - methylnicotinamide ( NMN ) was proposed as an in vivo probe for drug interactions involving renal cation transporters , which , for example , transport the oral antidiabetic drug metformin , based on a study with the inhibitor pyrimethamine .


The role of NMN for predicting other interactions with involvement of renal cation transporters ( organic cation transporter 2 , OCT2 ; multidrug and toxin extrusion proteins 1 and 2-K , MATE1 and MATE2-K ) is unclear .


We determined inhibition of metformin or NMN transport by trimethoprim using cell lines expressing OCT2 , MATE1 , or MATE2-K .


Moreover , a randomized , open-label , two-phase crossover study was performed in 12 healthy volunteers .


In each phase , 850 mg metformin hydrochloride was administered p.o. in the evening of day 4 and in the morning of day 5 .


In phase B , 200 mg trimethoprim was administered additionally p.o. twice daily for 5 days .


Metformin pharmacokinetics and effects ( measured by OGTT ) and NMN pharmacokinetics were determined .


Trimethoprim inhibited metformin transport with K i values of 27.2 , 6.3 , and 28.9 M and NMN transport with IC50 values of 133.9 , 29.1 , and 0.61 M for OCT2 , MATE1 , and MATE2-K , respectively .


In the clinical study , trimethoprim increased metformin area under the plasma concentration-time curve ( AUC ) by 29.5 % and decreased metformin and NMN renal clearances by 26.4 and 19.9 % , respectively ( p 0.01 ) .


Moreover , decreases of NMN and metformin renal clearances due to trimethoprim correlated significantly ( r S = 0.727 , p = 0.010 ) .


These data on the metformin-trimethoprim interaction support the potential utility of N ( 1 ) - methylnicotinamide as an endogenous probe for renal drug-drug interactions with involvement of renal cation transporters .


Variability in responsiveness to clopidogrel is a clinical problem in secondary prevention after cerebral ischaemia which has been suggested to be linked to competitive metabolization of clopidogrel and cytochrome P450 ( CYP ) 3A4-oxidated statins such as simvastatin .


We assessed the hypothesis that simvastatin , in contrast to CYP 2C9-metabolized fluvastatin , reduces clopidogrel-mediated platelet inhibition .


We performed a randomized , double-blind , double-dummy , two period crossover study in 13 patients with cerebral ischaemia ( 8F , 5M ) , aged 64.18.0 years ( meanSD ) .


After a 14 day period in which all patients received 75mg clopidogrelday ( -1 ) , patients additionally received either 20mg simvastatinday ( -1 ) or 80mg fluvastatinday ( -1 ) for 14 days .


Regimens were crossed over after a 14 day wash-out period and switched regimens were continued for another 14 days .


Platelet aggregation , clopidogrel active metabolite ( CAM ) plasma concentrations and routine laboratory parameters including prothrombin time ( PT ) Quick percent value were assessed at baseline and following each treatment phase .


Clopidogrel reduced platelet aggregation in all patients as expected .


Platelet aggregation and CAM plasma concentrations were unaltered when simvastatin or fluvastatin was added to clopidogrel .


Simvastatin decreased PT Quick percent value ( decrease from 10910.5 % to 10311 % , P < 0.05 ) when combined with clopidogrel but there was no such change following treatment with fluvastatin and clopidogrel .


Our data indicate that treatment with CYP 3A4-metabolized simvastatin does not jeopardize clopidogrel-mediated inhibition of platelet aggregation .


After co-administration of simvastatin and clopidogrel we observed a decrease in the PT Quick percent value which could be due to simvastatin-induced reduction of activity of prothrombin fragment 1 + 2 .


The aim of this study was to test the efficacy of long-term , daily intake of erythritol and xylitol candy , compared with sorbitol candy , on the development of enamel and dentin caries lesions .


The study was a double-blind randomized controlled prospective clinical trial .


Altogether 485 primary school children , first - and second-graders at baseline , from southeastern Estonia participated in this 3-year intervention .


Each child consumed four erythritol , xylitol or sorbitol ( control ) candies three times per school day .


The daily intake of polyol was about 7.5 g.


The International Caries Detection and Assessment System ( ICDAS ) was used in the clinical examinations by four calibrated examiners at baseline and at 12 , 24 and 36 months .


The annual examination analyses and the follow-up analyses confirmed that the number of dentin caries teeth and surfaces at 24 months follow-up and surfaces at 36 months follow-up was significantly lower in the mixed dentition in the erythritol group than in the xylitol or control group .


Time of enamel/dentin caries lesions to develop and of dentin caries lesions to progress was significantly longer in the erythritol group compared to the sorbitol and xylitol groups .


Also the increase in caries score was lower in the erythritol group than in the other groups .


In the follow-up examinations , a lower number of dentin caries teeth and surfaces was found in the erythritol group than in the xylitol or control groups .


Time to the development of caries lesions was longest in the erythritol group .


ClinicalTrials.gov Identifier NCT01062633 .


Patients ' recall of provided information during bad news consultations is poor .


According to the attentional narrowing hypothesis , the emotional arousal caused by the bad news might be responsible for this hampered information processing .


Because affective communication has proven to be effective in tempering patients ' emotional reactions , the current study used an experimental design to explore whether physician 's affective communication in bad news consultations decreases patients ' anxiety and uncertainty and improves information recall .


Two scripted video-vignettes of a bad news consultation were used in which the physician 's verbal communication was manipulated ( standard vs. affective condition ) .


Fifty healthy women ( i.e. , analogue patients ) randomly watched 1 of the 2 videos .


The effect of communication on participants ' anxiety , uncertainty , and recall was assessed by self-report questionnaires .


Additionally , a moderator analysis was performed .


Affective communication reduced anxiety ( p = .01 ) and uncertainty ( p = .04 ) , and improved recall ( p = .05 ) , especially for information about prognosis ( p = .04 ) and , to some extent , for treatment options ( p = .07 ) .


The moderating effect of ( reduced ) anxiety and uncertainty on recall could not be confirmed and showed a trend for uncertainty .


Physicians ' affective communication can temper patients ' anxiety and uncertainty during bad news consultations , and enhance their ability to recall medical information .


The reduction of anxiety and uncertainty could not explain patients ' enhanced recall , which leaves the underlying mechanism unspecified .


Our findings underline the importance of addressing patients ' emotions and provide empirical support to incorporate this in clinical guidelines and recommendations .


Trials aimed at preventing cognitive decline through cognitive stimulation among those with normal cognition or mild cognitive impairment are of significant importance in delaying the onset of dementia and reducing dementia prevalence .


One challenge in these prevention trials is sample recruitment bias .


Those willing to volunteer for these trials could be socially active , in relatively good health , and have high educational levels and cognitive function .


These participants ' characteristics could reduce the generalizability of study results and , more importantly , mask trial effects .


We developed a randomized controlled trial to examine whether conversation-based cognitive stimulation delivered through personal computers , a webcam and the internet would have a positive effect on cognitive function among older adults with normal cognition or mild cognitive impairment .


To examine the selectivity of samples , we conducted a mass mail-in survey distribution among community-dwelling older adults , assessing factors associated with a willingness to participate in the trial .


Two thousand mail-in surveys were distributed to retirement communities in order to collect data on demographics , the nature and frequency of social activities , personal computer use and additional health-related variables , and interest in the prevention study .


We also asked for their contact information if they were interested in being contacted as potential participants in the trial .


Of 1,102 surveys returned ( 55.1 % response rate ) , 983 surveys had complete data for all the variables of interest .


Among them , 309 showed interest in the study and provided their contact information ( operationally defined as the committed with interest group ) , 74 provided contact information without interest in the study ( committed without interest group ) , 66 showed interest , but provided no contact information ( interest only group ) , and 534 showed no interest and provided no contact information ( no interest group ) .


Compared with the no interest group , the committed with interest group were more likely to be personal computer users ( odds ratio ( OR ) = 2.78 ) , physically active ( OR = 1.03 ) and had higher levels of loneliness ( OR = 1.16 ) .


Increasing potential participants ' familiarity with a personal computer and the internet before trial recruitment could increase participation rates and improve the generalizability of future studies of this type .


The trial was registered on 29 March 2012 at ClinicalTirals.gov ( ID number NCT01571427 ) .


The Institute of Medicine has included the comparison of minimally invasive surgical techniques in its research agenda .


This study seeks to evaluate a model for the comparison of minimally invasive procedures using patient-reported outcomes .


A double-blinded randomized controlled trial ( NCT01489436 ) was conducted .


Baseline data were obtained , standardized anesthesia was induced , and patients were randomized to single-port ( SP ) or 4-port ( FP ) laparoscopic cholecystectomy .


Perioperative care was standardized .


The outcomes were pain ( Visual Analog Scale ) on postoperative day 1 ( primary ) and quality of life ( Patient-Reported Outcomes Measures Information System and Linear Analog Self-Assessment ) , serum cytokines , and heart rate variability ( secondary ) .


Analysis was intention to treat .


Using identical occlusive dressings , patients and the outcomes assessor remained blinded until postoperative day 2 .


Fifty-five patients were randomized to each arm .


There was no difference in demographics .


Visual Analog Scale pain score on postoperative day 1 was significantly different from baseline in each group ( SP : 1.6 1.9 to 4.2 2.4 vs FP : 1.8 2.3 to 4.2 2.2 ) , but not different from each other ( p = 0.83 ) .


Patients in the FP arm reported significantly less fatigue on postoperative day 7 than patients in the SP group ( 3.1 2.1 vs 4.2 2.2 ; p = 0.009 ) .


Fewer patients in the FP group required postoperative oral narcotics before discharge ( 40 % vs 60 % ; p = 0.056 ) .


Cytokines levels and heart rate variability were similar between arms .


In patients followed for > 1 year , no difference in umbilical hernia rates was noted .


Early postoperative quality of life data captured differences in fatigue , indicating improved recovery after FP within a controlled trial .


Physiologic measures were similar , suggesting that the differences between SP and FP are minimal .


The aim of this study was to evaluate the effects of pistachio nuts as an adjunct to diet and exercise on body composition , metabolic , inflammatory , and oxidative stress parameters in Asian Indians with metabolic syndrome .


In this 24-wk randomized control trial , 60 individuals with the metabolic syndrome were randomized to either pistachio ( intervention group ) or control group ( diet as per weight and physical activity profile , modulated according to dietary guidelines for Asian Indians ) after 3 wk of a diet and exercise run in .


In the first group , unsalted pistachios ( 20 % energy ) were given daily .


A standard diet and exercise protocol was followed for both groups .


Body weight , waist circumference ( WC ) , magnetic resonance imaging estimation of intraabdominal adipose tissue and subcutaneous abdominal adipose tissue , fasting blood glucose ( FBG ) , fasting serum insulin , glycosylated hemoglobin , lipid profile , high-sensitivity C-reactive protein ( hs-CRP ) , adiponectin , free fatty acids ( FFAs ) , tumor necrosis factor ( TNF ) - , leptin , and thiobarbituric acid reactive substances ( TBARS ) were assessed before and after the intervention .


Statistically significant improvement in mean values for various parameters in the intervention group compared with control group were as follows : WC ( P < 0.02 ) , FBG ( P < 0.04 ) , total cholesterol ( P < 0.02 ) , low-density lipoprotein cholesterol ( P < 0.006 ) , hs-CRP ( P < 0.05 ) , TNF - ( P < 0.03 ) , FFAs ( P < 0.001 ) , TBARS ( P < 0.01 ) , and adiponectin levels ( P < 0.001 ) .


A single food intervention with pistachios leads to beneficial effects on the cardiometabolic profile of Asian Indians with metabolic syndrome .


Multidetector CT ( MDCT ) is the established imaging modality in diagnostics of urolithiasis .


The aim of iterative reconstruction ( IR ) is to allow for a radiation dose reduction while maintaining high image quality .


This study evaluates its performance in MDCT for assessment of urolithiasis .


Fifty-two patients underwent non-contrast abdominal MDCT .


Twenty-six patients were referred to MDCT under suspicion of urolithiasis , and examined using a dose-reduced scan protocol ( RDCT ) .


Twenty-six patients , who had undergone standard-dose MDCT , served as reference for radiation dose comparison .


RDCT images were reconstructed using an IR system ( iDose4 , Philips Healthcare , Cleveland , OH , USA ) .


Objective image noise ( OIN ) was recorded and five radiologists rated the subjective image quality independently .


Radiation parameters were derived from the scan protocols .


The CTDIvol could be reduced by 50 % to 5.8 mGy ( P < 0.0001 ) .


The same reduction was achieved for DLP and effective dose to 25327mGy * cm ( P < 0.0001 ) and 3.90.4 mSv ( P < 0.0001 ) .


IR led to a reduction of the OIN of up to 61 % compared with classic filtered back projection ( FBP ) ( P < 0.0001 ) .


The OIN declined with increasing IR levels .


RDCT with FBP showed the lowest scores of subjective image quality ( 2.320.04 ) .


Mean scores improved with increasing IR levels .


iDose6 was rated with the best mean score ( 3.660.04 ) .


The evaluated IR-tool and protocol may be applied to achieve a considerable radiation dose reduction in MDCT for diagnostics of urolithiasis while maintaining a confident image quality .


Best image quality , suitable for evaluation of the entire abdomen concerning differential diagnoses , was achieved with iDose6 .


To evaluate the role of calcium infusion as a preventive strategy of ovarian hyperstimulation syndrome ( OHSS ) in women at high risk in in vitro fertilization ( IVF ) / intracytoplasmic sperm injection ( ICSI ) treatment cycles .


Double-blinded randomized controlled trial .


University hospital department of obstetrics and gynecology and private IVF center .


Two hundred women at risk to develop OHSS undergoing IVF/ICSI treatment cycle .


The intervention group ( group 1 ; n = 100 ) received intravenous infusion of 10 mL 10 % calcium gluconate in 100 mL 0.9 % saline solution on the day of ovum pick-up ( OPU ) and days 1 , 2 , and 3 after , and the placebo group ( group 2 ; n = 100 ) received 100 mL 0.9 % saline solution on the day of OPU and days 1 , 2 , and 3 after .


Incidence of OHSS .


OHSS incidence was significantly higher in the placebo group ( group 2 ) than in the calcium infusion group ( group 1 ) : 23 ( 23 % ) vs. 7 ( 7 % ) ; moderate OHSS was significantly higher in group 2 than in group 1 : 8 ( 8 % ) vs. 1 ( 1 % ) ; and severe OHSS was significantly higher in group 2 than in group 1 : 4 ( 4 % ) vs. 0 .


Intravenous calcium infusion effectively reduced the incidence of OHSS development without reduction in the pregnancy rate .


NCT01427335 .


Constitutive activation of the epidermal growth factor receptor ( EGFR ) is prevalent in epithelial cancers , particularly in non-small cell lung carcinoma ( NSCLC ) .


Mutations identified in EGFR predict the sensitivity to EGFR-targeted therapy .


Detection of these mutations is mainly based on tissue biopsy , which is invasive , expensive , and time consuming .


Noninvasive , real-time , inexpensive detection and monitoring of EGFR mutations in patients with NSCLC is highly desirable .


We developed a novel core technology , electric field-induced release and measurement ( EFIRM ) , which relies on a multiplexible electrochemical sensor that can detect EGFR mutations directly in bodily fluids .


We established EFIRM for the detection of the EGFR mutations in vitro and correlated the results with tumor size from xenografted mice .


In clinical application , we demonstrated that EFIRM could detect EGFR mutations in the saliva and plasma of 22 patients with NSCLC .


Finally , a blinded test was performed on saliva samples from 40 patients with NSCLC .


The receiver operating characteristic analysis indicated that EFIRM detected the exon 19 deletion with an area under the curve of 0.94 and the L858R mutation with an area under the curve of 0.96 .


Our data indicate that EFIRM is effective , accurate , rapid , user-friendly , and cost effective for the detection of EGFR mutations in the saliva of patients with NSCLC .


We termed this saliva-based EGFR mutation detection ( SABER ) .


Postcancer fatigue is a frequently occurring problem , impairing quality of life .


Little is known about ( neuro ) physiological factors determining postcancer fatigue .


It may be hypothesized that postcancer fatigue is characterized by low peripheral muscle fatigue and high central muscle fatigue .


The aims of this study were to examine whether central and peripheral muscle fatigue differ between fatigued and non-fatigued cancer survivors and to examine the effect of cognitive behavioral therapy ( CBT ) on peripheral and central muscle fatigue of fatigued cancer survivors in a randomized controlled trial .


Sixteen fatigued patients in the intervention group ( CBT ) and eight fatigued patients in the waiting list group were successfully assessed at baseline and six months later .


Baseline measurements of 20 fatigued patients were compared with 20 non-fatigued patients .


A twitch interpolation technique and surface electromyography were applied , respectively , during sustained contraction of the biceps brachii muscle .


Muscle fiber conduction velocity ( MFCV ) and central activation failure ( CAF ) were not significantly different between fatigued and non-fatigued patients .


Change scores of MFCV and CAF were not significantly different between patients in the CBT and waiting list groups .


Patients in the CBT group reported a significantly larger decrease in fatigue scores than patients in the waiting list group .


Postcancer fatigue is neither characterized by abnormally high central muscle fatigue nor by low peripheral muscle fatigue .


These findings suggest a difference in the underlying physiological mechanism of postcancer fatigue vs. other fatigue syndromes .


Reactivation of human herpesvirus ( HHV ) -6 and HHV-7 has been linked to various posttransplant adverse events through immunomodulatory effects .


The potential utility of monitoring for HHV-6 and HHV-7 viremia remains unclear .


In this clinical trial , 129 liver transplant recipients were randomized to be monitored in real-time for HHV-6 and HHV-7 viremia by polymerase chain reaction at regular intervals from 0 to 12 weeks after transplantation ( `` monitoring '' group ) or to undergo usual care ( `` no-monitoring '' group ) .


Therapeutic intervention for a positive polymerase chain reaction result included reduction in immunosuppression and preemptive antiviral therapy , at the discretion of the attending team .


The primary outcome was a composite of adverse events indirectly attributable to viral reactivation ( including opportunistic infection , graft rejection and severe hepatitis C virus recurrence ) .


In the `` monitoring '' group , HHV-6 and HHV-7 viremia occurred in 23 of 64 patients ( 35.9 % ) and 21 of 64 patients ( 32.8 % ) patients , respectively .


We found no cases of symptomatic HHV-6 and HHV-7 disease .


Some therapeutic interventions were performed in 59.1 % of viremic episodes .


There were no differences in cumulative incidence of the primary outcome between the `` monitoring '' and `` no-monitoring '' groups at 1 year ( 58.7 % vs. 52.3 % ; odds ratio , 0.77 ; 95 % confidence interval , 0.38-1 .55 ) or at 5 years after transplantation ( 79.0 % vs. 70.3 % ; odds ratio , 0.63 ; 95 % confidence interval , 0.28-1 .42 ) .


However , we found a trend toward a lower incidence of graft rejection at year 1 in the `` monitoring '' group ( 30.2 % vs. 44.6 % ; P = 0.091 ) .


In this first trial , no benefit could be demonstrated from routine monitoring of HHV-6 and HHV-7 viremia in graft or patient outcome after liver transplantation .


To compare therapeutic effects between suspine rotation and flexion manipulation for treating lumbar disc herniation .


From December 2008 to January 2011 , 134 patients with lumbar disc herniation were treated , including 74 males and 60 females , ranging in age from 17 to 67 years ,33 patients with age over 50 years old .


According to diagnosis the ladder of the 9 cases bulging type , 74 hernia type , 51 cases free type .


The patients were randomly divided into treatment group ( 69 cases ) and control group ( 65 cases ) .


All the patients were treated with the three-dimensional computer-controlled traction therapeutic apparatus , with continued traction for 20 minutes .


After traction , flexion manipulation and rotat-ing manipulation were respectively adopted in treatment group and control group ( on alternate days one time , 3 times as a course of treatment ) .


The symptoms and signs ( including back pain and discomfort , lower limb pain and numbness , powerless urination and defecation , numbness in perineum , straight-leg raising degree , ability of lower extremity walking , work and live ) of patients were observed after treatment .


All patients were followed up for 0.5 to 6 months with an average of 1.1 months .


After treatment , the symptoms and signs of patients have significantly improved ( P < 0.01 ) , but the symptomes of powerless urination and defecation , numbness in perineum was not improved obviously ( P > 0.05 ) .


Forty-two of 69 patients in treatment group got excellent result , moderate in 20 , poor in 7 ; Twenty of 65 patients in control group got excellent result , moderate in 25 , poor in 20 .


The whole effect of lumbar backwards rotation manipulation is more satisfactory than flexsion manipulation for treating lumbar intervertebral disc herniation .


But spinning force and times should be noticed .


Gastroscopy and gastroscopic mucosal biopsy techniques have become increasingly used as of late for evaluating symptoms presumed to be originated in the upper gastrointestinal tract .


Patients often complain however of abdominal pain post-gastroscopic mucosal biopsy , and this study aimed to explore the necessity of acid inhibitors when abdominal pain worsened .


In this randomized , double-blinded , placebo-controlled study , we screened 272 participants , and ultimately enrolled 200 into the study .


These 200 participants were randomly assigned in a 1:1 ratio to receive acid inhibitors ( esomeprazole , treatment group , n = 100 ; dose ,20 mg/d ) or matched placebo ( control group , n = 100 ) for 3 days post-gastroscopic mucosal biopsy .


The presence of abdominal pain was observed pre-and post-gastroscopy , and the therapeutic effect of esomeprazole was assessed .


This study was registered at the Chinese clinical trial registry as ChiCTR-TRC-00000500 .


Ten subjects were lost to followup ( 4 in treatment group ; 6 in the control group ) .


There was no significant difference in the number of subjects with aggravating abdominal pain ( treatment 29.2 % vs. control 22.3 % ; p > 0.05 ) between the two groups .


Esomeprazole did not significantly ( p > 0.05 ) affect the rate of abdominal pain within 24 h ( treatment 27.1 % vs. control 19.1 % ) , 48 h ( treatment 40.6 % vs. control 27.7 % ) , and 96 h ( treatment 43.8 % vs. control 34.0 % ) on abdominal pain in all in the evaluated subjects .


Between the two groups however , a statistically significant difference ( p < 0.05 ) was found on overall effective treatment rates at 48 h ( treatment 92.9 % vs. control 66.7 % ) and at 96 h ( treatment 100 % vs. control 81 % ) in the subjects with worsened abdominal pain .


The study suggests that routine prophylaxis with acid inhibitors is not recommended for all patients post-gastroscopic mucosal biopsy , however acid inhibitors should be administered for patients with aggravating abdominal pain .


To characterize relationships between specific immune cell subsets in bone marrow ( BM ) or granulocyte colony-stimulating factor-mobilized peripheral blood ( PB ) stem cells collected from unrelated donors and clinical outcomes of patients undergoing transplantation in BMTCTN 0201 .


Fresh aliquots of 161 BM and 147 PB stem-cell allografts from North American donors randomly assigned to donate BM or PB stem cells and numbers of transplanted cells were correlated with overall survival ( OS ) , relapse , and graft-versus-host disease ( GvHD ) .


Patients with evaluable grafts were similar to all BMTCTN 0201 patients .


The numbers of plasmacytoid dendritic cells ( pDCs ) and nave T cells ( Tns ) in BM allografts were independently associated with OS in multivariable analyses including recipient and donor characteristics , such as human leukocyte antigen mismatch , age , and use of antithymocyte globulin .


BM recipients of > median number of pDCs , nave CD8 ( + ) T cells ( CD8Tns ) , or nave CD4 ( + ) T cells ( CD4Tns ) had better 3-year OS ( pDCs , 56 % v 35 % ; P = .025 ; CD8Tns , 56 % v 37 % ; P = .012 ; CD4Tns , 55 % v 37 % ; P = .009 ) .


Transplantation of more BM Tns was associated with less grade 3 to 4 acute GvHD but similar rates of relapse .


Transplantation of more BM pDCs was associated with fewer deaths resulting from GvHD or from graft rejection .


Analysis of PB grafts did not identify a donor cell subset significantly associated with OS , relapse , or GvHD .


Donor immune cells in BM but not PB stem-cell grafts were associated with survival after unrelated-donor allogeneic hematopoietic stem-cell transplantation .


The biologic activity of donor immune cells in allogeneic transplantation varied between graft sources .


Donor grafts with more BM-derived Tns and pDCs favorably regulated post-transplantation immunity in allogeneic hematopoietic stem-cell transplantation .


Tryptophan not only is an amino acid essential to protein synthesis but also serves as a precursor in 2 important metabolic pathways : the serotonin and the kynurenine pathways .


Tryptophan is related to sleeping patterns .


The objective of the present study was to determine the tryptophan requirement of term infants using the indicator amino acid oxidation ( IAAO ) method with L - [ 1-C ] phenylalanine as the indicator .


Enterally fed infants were randomly assigned to tryptophan intakes ranging from 0.5 to 73mgkgday as part of an elemental diet .


After 1-day adaptation to the test diet , [ C ] bicarbonate and L - [ 1-C ] phenylalanine tracers were given enterally .


Breath samples were collected at baseline and during isotopic plateaus .


The mean tryptophan requirement was determined by using the biphasic linear regression crossover analysis on the fraction of CO2 recovery from L - [ 1-C ] phenylalanine oxidation ( FCO2 ) .


Data are presented as meanstandard deviation .


A total of 30 term neonates ( gestational age 391 weeks ) were studied at 94 days .


FCO2 decreased until a tryptophan intake of 15mgkgday ; additional increases in tryptophan intake did not affect FCO2 .


Mean requirement was determined to be 15mgkgday .


The mean tryptophan requirement for elemental formula-fed term infants is 15mgkgday .


This requirement is lower than the present recommended intake of 29mgkgday , which is based on the average intake of a breastfed infant .


Although the surgical and oncological therapies of primary spinal tumors ( PSTs ) have changed significantly over the last few decades , the prognosis of this rare disease is still poor .


The decision-making process in the multidisciplinary management is handicapped by the lack of large-scale population-based prognostic studies .


The objective of the present study was to investigate preoperative factors associated with PST mortality and to develop a predictive scoring system of poor survival .


This is a large-scale ambispective cohort study .


The study included 323 consecutive patients with PSTs , treated surgically over an 18-year period at a tertiary care spine referral center for a population of 10 million .


Survival was the outcome measure .


Patients were randomly divided into a training cohort ( n = 273 ) and a validation cohort ( n = 50 ) .


In the training cohort , 12 preoperative factors were investigated using Cox proportional hazard models .


Based on the mortality-related variables , a simple scoring system of mortality was created , and three groups of patients were identified .


Kaplan-Meier and log-rank analyses were used to compare the survival in the three groups .


The model performance was assessed by measuring the discriminative ability ( c-index ) of the model and by applying a pseudo-R ( 2 ) goodness-of-fit test ( Nagelkerke R ( 2 ) , RN ( 2 ) ) .


Internal validation was performed using bootstrapping in the training cohort and assessing the discrimination and explained variation of the model in the validation cohort .


Patient age , spinal region , tumor grade , spinal pain , motor deficit , and myelopathy/cauda equina syndrome were significantly associated with poor survival in the multivariate analysis ( p < .001 , RN ( 2 ) = 0.799 ) .


Based on these variables , we developed the Primary Spinal Tumor Mortality Score ( PSTMS ) , where an eight-point scale was divided into three categories ( low , medium , and high mortality ) .


The three PSTMS categories were significantly associated with the overall survival ( p < .001 , RN ( 2 ) = 0.811 , c = 0.82 ) .


The model performance remained similarly high in the validation cohort ( RN ( 2 ) = 0.831 , c = 0.81 ) .


The present study identifies six predictive variables for mortality in PSTs .


Using these six variables , an easy-to-use scoring system was developed that can be applied to the estimation of postoperative survival in all types of PST patients .


To prospectively assess the added value of gadolinium-enhanced and diffusion-weighted ( DWI ) MRI for the diagnosis of pelvic recurrence from colorectal cancer ( CRC ) .


Fifty-two patients with suspected pelvic recurrence from CRC underwent pelvic MRI with T2-weighted ( `` T2 '' ) , gadolinium-enhanced fat-suppressed T1-weighted ( `` gadolinium '' ) and DWI MR sequences .


Three readers ( senior radiologist : R1 , two residents : R2 , R3 ) scored the likelihood of recurrence on `` T2 , '' `` T2 + DWI , '' and `` T2 + Gadolinium . ''


Twenty-seven patients had 42 sites of pelvic recurrence .


On `` T2 , '' R1 achieved AUC of .95 , sensitivity 88.4 % , specificity 95.2 % .


For R2 , these figures were .89 , 81.4 % , 90.5 % , for R3 .90 , 83.7 % , 76 % .


Both Gadolinium injection and DWI significantly improved AUCs for residents but not for the senior radiologist : up to .988 ( R2 , P = 0.006 ) and to .98 ( R3 , P = 0.01 ) with DWI and to .96 ( R2 , P = 0.04 ) , .98 ( R3 , P = 0.01 ) after gadolinium .


All readers achieved slightly better AUCs with `` T2 + DWI '' than with `` T2 + Gadolinium '' but not significantly ( P = 0.68 , P = 0.11 , P = 0.3 ; respectively ) .


For diagnosis of pelvic recurrence from CRC , both DWI and gadolinium-enhanced MRI significantly increase diagnostic performances compared with `` T2 '' MRI for residents .


DWI may be helpful in patients with contra-indications to intravenous administration of gadolinium .


Upper lip wounds that lie perpendicular to the relaxed skin tension lines are subjected to repetitive dynamic tension caused by the orbicularis oris muscle and are susceptible to unsatisfactory scarring .


In this double-blind , randomized , vehicle-controlled , prospective trial , 60 consecutive patients with unilateral cleft lip undergoing primary cheiloplasties between August of 2011 and June of 2012 were randomized to receive botulinum toxin type A or vehicle injections into the subjacent orbicularis oris muscle immediately after wound closure .


Scars were assessed after 6 months using the Vancouver Scar Scale , photographic visual analogue scale , and photographic scar width measurements .


Fifty-nine patients completed the trial .


Measurements of scar widths at two defined points revealed significantly better visual analogue scale scores and narrower scars in the experimental group .


However , Vancouver Scar Scale assessments were similar between groups .


Botulinum toxin injections into the subjacent orbicularis oris muscle produced better appearing and narrower cheiloplasty scars , but provided no additional benefits in terms of scar pigmentation , vascularity , pliability , or height .


Therapeutic , II .


To investigate the efficacy of tandospirone in patients with irritable bowel syndrome-diarrhea ( IBS-D ) and anxiety in a prospective , randomized , controlled study .


Two hundred patients with IBS-D and moderate anxiety were randomized to receive pinaverium and tandospirone ( arm A ) or pinaverium and placebo ( arm B ) .


Tandospirone or placebo was given thrice daily at a fixed dose of 10 mg and pinaverium was given thrice daily at a fixed dose of 50 mg .


The duration of treatment was 8 wk .


Patients were assessed for abdominal pain and diarrhea .


Anxiety was evaluated using the Hamilton Rating Scale for Anxiety ( HAM-A ) .


The primary study endpoints were response rates for abdominal pain and diarrhea .


The secondary study endpoints were response rates for anxiety .


Adverse events were also evaluated .


One hundred and seventy of 200 patients ( 82 patients in arm A and 88 patients in arm B ) completed the study .


Demographic and baseline characteristics of the 200 participants were comparable in the two arms .


At week 8 , the overall response rate for abdominal pain and diarrhea was 52.0 % for arm A and 37.0 % for arm B ( P < 0.05 ) .


The HAM-A score showed that the response rate was 61.0 % for arm A and 21.0 % for arm B ( P < 0.01 ) .


The treatments were well tolerated and no significant adverse events were reported .


Tandospirone is effective and can be combined with pinaverium in IBS-D patients with anxiety .


Provision of essential newborn care ( ENC ) can save many newborn lives in poor resource settings but coverage is far from universal and varies by country and place of delivery .


Understanding gaps in current coverage and where coverage is good , in different contexts and places of delivery , could make a valuable contribution to the future design of interventions to reduce neonatal mortality .


We sought to describe the coverage of essential newborn care practices for births in institutions , at home with a skilled birth attendant , and at home without a skilled birth attendant ( SBA ) in rural areas of Bangladesh , Nepal , and India .


We used data from the control arms of four cluster randomised controlled trials in Bangladesh , Eastern India and from Makwanpur and Dhanusha districts in Nepal , covering periods from 2001 to 2011 .


We used these data to identify essential newborn care practices as defined by the World Health Organization .


Each birth was allocated to one of three delivery types : home birth without an SBA , home birth with an SBA , or institutional delivery .


For each study , we calculated the observed proportion of births that received each care practice by delivery type with 95 % confidence intervals , adjusted for clustering and , where appropriate , stratification .


After exclusions , we analysed data for 8939 births from Eastern India , 27 553 births from Bangladesh , 6765 births from Makwanpur and 15 344 births from Dhanusha .


Across all study areas , coverage of essential newborn care practices was highest in institutional deliveries , and lowest in home non-SBA deliveries .


However , institutional deliveries did not provide universal coverage of the recommended practices , with relatively low coverage ( 20 % -70 % ) across all study areas for immediate breastfeeding and thermal care .


Institutions in Bangladesh had the highest coverage for almost all care practices except thermal care .


Across all areas , fewer than 20 % of home non-SBA deliveries used a clean delivery kit , the use of plastic gloves was very low and coverage of recommended thermal care was relatively poor .


There were large differences between study areas in handwashing , immediate breastfeeding and delayed bathing .


There remains substantial scope for health facilities to improve thermal care for the newborn and to encourage immediate and exclusive breastfeeding .


For unattended home deliveries , increased handwashing , use of clean delivery kits and basic thermal care offer great scope for improvement .


To evaluate the safety , tolerability , and pharmacokinetics ( PK ) of pregabalin as adjunctive therapy in children with refractory partial seizures .


This was a phase 1 , randomized , placebo-controlled , parallel-group , escalating-dose , multiple-dose study comprising a 7-day , double-blind treatment period and a single-blind , single dose of pregabalin administered to all children on day 8 .


Children in four age cohorts ( 1-23 months , 2-6 , 7-11 , and 12-16 years ) received one of four doses of pregabalin ( 2.5 , 5 , 10 , or 15 mg/kg/day ) or placebo .


Safety and tolerability were assessed throughout the study .


Steady-state and single-dose PK parameters on day 8 were analyzed using standard noncompartmental procedures .


Sixty-five children received at least one dose of treatment .


Four pregabalin-treated children discontinued treatment , three of whom received 15 mg/kg/day .


Two children experienced serious adverse events , one of whom received pregabalin 15 mg/kg/day .


During double-blind treatment , the most common adverse events reported in the pregabalin-treated population were somnolence ( 27.1 % ) and dizziness ( 12.5 % ) .


Steady-state pregabalin peak and total exposure in each age cohort appeared to increase linearly with dose .


Apparent oral clearance ( CL/F ) was directly related to creatinine clearance , consistent with adults .


CL/F normalized for body weight was 43 % higher in patients weighing < 30 kg .


Steady-state and single-dose PK were consistent .


Pregabalin at doses up to 10 mg/kg/day in children aged 1 month to 16 years , and at doses up to 15 mg/kg/day in those aged < 6 years , demonstrated acceptable safety and tolerability .


For children weighing < 30 kg , a dose increase of 40 % ( mg/kg dosing ) is required to achieve comparable exposure with adults or children weighing 30 kg .


These data will inform dose selection in phase 3 trials of the efficacy and safety of adjunctive pregabalin in children with refractory partial seizures .


Intraoperative radiotherapy with electrons allows the substitution of conventional postoperative whole breast irradiation with one session of radiotherapy with the same equivalent dose during surgery .


However , its ability to control for recurrence of local disease required confirmation in a randomised controlled trial .


This study was done at the European Institute of Oncology ( Milan , Italy ) .


Women aged 48-75 years with early breast cancer , a maximum tumour diameter of up to 25 cm , and suitable for breast-conserving surgery were randomly assigned in a 1:1 ratio ( using a random permuted block design , stratified for clinical tumour size [ < 10 cm vs 10-14 cm vs 15 cm ] ) to receive either whole-breast external radiotherapy or intraoperative radiotherapy with electrons .


Study coordinators , clinicians , and patients were aware of the assignment .


Patients in the intraoperative radiotherapy group received one dose of 21 Gy to the tumour bed during surgery .


Those in the external radiotherapy group received 50 Gy in 25 fractions of 2 Gy , followed by a boost of 10 Gy in five fractions .


This was an equivalence trial ; the prespecified equivalence margin was local recurrence of 75 % in the intraoperative radiotherapy group .


The primary endpoint was occurrence of ipsilateral breast tumour recurrences ( IBTR ) ; overall survival was a secondary outcome .


The main analysis was by intention to treat .


This trial is registered with ClinicalTrials.gov , number NCT01849133 .


1305 patients were randomised ( 654 to external radiotherapy and 651 to intraoperative radiotherapy ) between Nov 20 , 2000 , and Dec 27 , 2007 .


After a medium follow-up of 58 years ( IQR 41-77 ) , 35 patients in the intraoperative radiotherapy group and four patients in the external radiotherapy group had had an IBTR ( p < 00001 ) .


The 5-year event rate for IBRT was 44 % ( 95 % CI 27-61 ) in the intraoperative radiotherapy group and 04 % ( 00-10 ) in the external radiotherapy group ( hazard ratio 93 [ 95 % CI 33-263 ] ) .


During the same period , 34 women allocated to intraoperative radiotherapy and 31 to external radiotherapy died ( p = 059 ) .


5-year overall survival was 968 % ( 95 % CI 953-983 ) in the intraoperative radiotherapy group and 969 % ( 955-983 ) in the external radiotherapy group .


In patients with data available ( n = 464 for intraoperative radiotherapy ; n = 412 for external radiotherapy ) we noted significantly fewer skin side-effects in women in the intraoperative radiotherapy group than in those in the external radiotherapy group ( p = 00002 ) .


Although the rate of IBTR in the intraoperative radiotherapy group was within the prespecified equivalence margin , the rate was significantly greater than with external radiotherapy , and overall survival did not differ between groups .


Improved selection of patients could reduce the rate of IBTR with intraoperative radiotherapy with electrons .


Italian Association for Cancer Research , Jacqueline Seroussi Memorial Foundation for Cancer Research , and Umberto Veronesi Foundation .


We aimed to evaluate the effect of a decision aid ( DA ) with information only compared to a DA with values clarification exercise ( VCE ) , and to study the role of personality and information seeking style in DA-use , decisional conflict ( DC ) and knowledge .


Two scenario-based experiments were conducted with two different groups of healthy female participants .


Dependent measures were : DC , knowledge , and DA-use ( time spent , pages viewed , VCE used ) .


Respondents were randomized between a DA with information only ( VCE - ) and a DA with information plus a VCE ( VCE + ) ( experiment 1 ) , or between information only ( VCE - ) , information plus VCE without referral to VCE ( VCE + ) , and information plus a VCE with specific referral to the VCE , requesting participants to use the VCE ( VCE + + ) ( experiment 2 ) .


In experiment 2 we additionally measured personality ( neuroticism/conscientiousness ) and information seeking style ( monitoring/blunting ) .


Experiment 1 .


There were no differences in DC , knowledge or DA-use between VCE - ( n = 70 ) and VCE + ( n = 70 ) .


Both DAs lead to a mean gain in knowledge from 39 % at baseline to 73 % after viewing the DA .


Within VCE + , VCE-users ( n = 32 , 46 % ) reported less DC compared to non-users .


Since there was no difference in DC between VCE - and VCE + , this is likely an effect of VCE-use in a self-selected group , and not of the VCE per se .


Experiment 2 .


There were no differences in DC or knowledge between VCE - ( n = 65 ) , VCE + ( n = 66 ) , VCE + + ( n = 66 ) .


In all groups , knowledge increased on average from 42 % at baseline to 72 % after viewing the DA .


Blunters viewed fewer DA-pages ( R = 0.38 , p < .001 ) .


More neurotic women were less certain ( R = 0.18 , p < .01 ) and felt less supported in decision making ( R = 0.15 , p < .05 ) ; conscientious women felt more certain ( R = -0.15 , p < .05 ) and had more knowledge after viewing the DA ( R = 0.15 , p < .05 ) .


Both DAs lead to increased knowledge in healthy populations making hypothetical decisions , and use of the VCE did not improve knowledge or DC .


Personality characteristics were associated to some extent with DA-use , information seeking styles with aspects of DC .


More research is needed to make clear recommendations regarding the need for tailoring of information provision to personality characteristics , and to assess the effect of VCE use in actual patients .


Acute viral tonsillitis is an upper respiratory tract infection prevalent in school-aged children .


Because this condition is self-limiting , conventional treatment options are usually palliative .


Homeopathic remedies are a useful alternative to conventional medications in acute uncomplicated upper respiratory tract infections in children , offering earlier symptom resolution , cost-effectiveness , and fewer adverse effects .


This study aimed to determine the efficacy of a homeopathic complex on the symptoms of acute viral tonsillitis in African children in South Africa .


This was a randomized , double-blind , placebo-controlled , 6-day pilot study .


Thirty children , age 6 to 12 years , with acute viral tonsillitis were recruited from a primary school in Gauteng , South Africa .


Participants took two tablets of the medication four times daily .


The treatment group received lactose tablets medicated with the homeopathic complex ( Atropa belladonna D4 , Calcarea phosphoricum D4 , Hepar sulphuris D4 , Kalium bichromat D4 , Kalium muriaticum D4 , Mercurius protoiodid D10 , and Mercurius biniodid D10 ) .


The placebo consisted of the unmedicated vehicle only .


The Wong-Baker FACES Pain Rating Scale measured pain intensity , and a Symptom Grading Scale assessed changes in tonsillitis signs and symptoms .


The treatment group had a statistically significant improvement in the following symptoms compared with the placebo group : pain associated with tonsillitis , pain on swallowing , erythema and inflammation of the pharynx , and tonsil size .


The homeopathic complex used in this study exhibited significant anti-inflammatory and pain-relieving qualities in children with acute viral tonsillitis .


No patients reported any adverse effects .


These preliminary findings are promising ; however , the sample size was small and therefore a definitive conclusion can not be reached .


A larger , more inclusive research study should be undertaken to verify the findings of this study .


Endovascular stenting is a safe , effective treatment of hepatic artery stenosis after liver transplant , but no detailed evaluation has been completed of changes in ultrasound monitoring parameters after stenting .


This study aims to improve poststenting surveillance by delineating the expected postoperative findings .


Thirty-one stent procedures were performed at our institution for hepatic artery stenosis after liver transplant between October 2010 and October 2012 .


Of these , 28 ( 90 % ) were technically successful , of which 23 met the minimum follow-up time ( 76 days , defined by the earliest diagnosed restenosis ) .


These patients were followed with serial ultrasound , per the following schedule : within 1 week of stenting , 3 months after stenting , 6 months after stenting , and every 6 months thereafter ; additional , unscheduled examinations were frequently performed when indicated on the basis of deterioration of clinical and laboratory status .


Follow-up examinations ( mean , 268 days total follow-up ) were compared with prestenting examinations to evaluate changes in peak systolic velocity ( PSV ) , resistive index ( RI ) , and tardus-parvus waveforms .


Data were analyzed to determine a normal range for postprocedure values and time course of change in values .


Of the 23 patients , six experienced restenosis .


In all patients , mean PSV decreased by 124 cm/s , and mean RI increased by 0.13 within 48 hours after stenting .


PSV differed between patency and restenosis groups only at more than 90 days after stenting ( mean PSV , 234 and 400 cm/s , respectively ) , with PSV above 300 cm/s serving as a high-sensitivity threshold for the determination of restenosis .


Prestenting RI of below 0.40 had a strong correlation with restenosis .


Poststenting RI differed between patency and restenosis groups only at more than 48 hours after stenting , with RI of below 0.55 having a strong correlation with restenosis .


Tardus-parvus waveform resolution was often delayed well beyond 48 hours after stenting , and time to tardus-parvus waveform resolution had no correlation with patency or restenosis .


Ultrasound is convenient and useful to follow stents in hepatic artery stenosis after liver transplant .


Prestenting hemodynamics can have value in predicting restenosis .


Diagnosis of restenosis can be made with RI and PSV , whereas resolution time of tardus-parvus waveform is of less concern .


These parameters can guide which patients require closer monitoring and aggressive treatment .


Cardiac surgery is associated with excessive bleeding that is as a result of coagulopathy caused by cardiopulmonary bypass .


We evaluated the effect of two different modalities for administering similar doses of tranexamic acid on bleeding following primary elective coronary artery bypass grafting ( CABG ) .


In the randomized control trial .


137 patients scheduled for CABG were randomized to two groups applying different modalities of tranexamic acid administration ( bolus injection of 30 mg/kg vs. continuous infusion ) .


Blood loss until removal of chest tubes was the primary outcome measure ; we also recorded and assessed blood products transfused , and length of ICU stay .


Both the groups were comparable at baseline .


Trends toward transfusion differences between groups were not statistically significant .


No differences in length of ICU stay , morbidity or mortality were found .


In CABG surgery , the use of either method for administering similar doses of tranexamic acid leads to a similarl reduction in postoperative mediastinal bleeding .


This study was conducted to evaluate the efficacy of extracorporeal shock wave therapy ( ESWT ) on the healing rate , wound surface area and wound bed preparation in chronic diabetic foot ulcers ( DFU ) .


Thirty eight patients with 45 chronic DFU were randomly assigned into ; the ESWT-group ( 19 patients/24 ulcers ) and the control-group ( 19 patients/21 ulcers ) .


Blinded therapist measured wound surface area ( WSA ) , the percentage of reduction in the WSA , rate of healing and wound bed preparation at baseline , after the end of the interventions ( W8 ) , and at 20-week follow-up ( W20 ) .


The ESWT group received shock wave therapy twice per week for a total of eight treatments .


Each ulcer was received ESWT at a frequency of 100 pulse/cm ( 2 ) , and energy flux density of 0.11 mJ/cm ( 2 ) .


All patients received standardized wound care consisting of debridement , blood-glucose control agents , and footwear modification for pressure reduction .


The overall clinical results showed completely healed ulcers in 33.3 % and 54 % in ESWT-groups and 14.28 % and 28.5 % in the control group after intervention ( W8 ) , and at follow-up ( W20 ) respectively .


The average healing time was significantly lower ( 64.5 8.06 days vs 81.17 4.35 days , p < 0.05 ) in the ESWT-group compared with the control group .


ESWT-treated ulcers had a significant reduction in wound size and median time required for ulcer healing , with no adverse reactions .


So , the ESWT is advocated as an adjunctive therapy in chronic diabetic wound .


Many African infants fail to receive their diagnostic HIV molecular test results and subsequently , antiretroviral therapy ( ART ) .


To determine whether a point-of-care molecular HIV test increases ART access for hospitalized Malawian infants , we simulated a point-of-care test using rapid HIV RNA polymerase chain reaction ( Rapid PCR ) and compared patient outcomes with an optimized standard care that included assessment with the World Health Organization clinical algorithm for HIV infection plus a DNA PCR with a turnaround time of several weeks ( standard care ) .


Randomized controlled trial .


Hospitalized HIV-exposed Malawian infants aged < 12 months were randomized into Rapid PCR or standard care .


Rapid PCR infants obtained molecular test results within 48 hours to facilitate immediate ART , similar to a point-of-care test .


Standard care infants meeting clinical criteria were also offered inpatient ART .


The primary outcome was appropriate in-hospital ART for DNA or RNA PCR-confirmed HIV-infected infants .


Three hundred infants were enrolled .


A greater proportion of HIV-infected infants receiving Rapid PCR , versus standard care , started inpatient ART ( 72.3 % vs 47.8 % , P = 0.016 ) .


Among molecular test-negative infants , 26.9 % receiving standard care unnecessarily initiated inpatient ART , versus 0.0 % receiving Rapid PCR ( P < 0.001 ) .


Rapid PCR modestly reduced the median days to ART ( 3.0 vs 6.5 , P = 0.001 ) but did not influence outpatient follow-up for HIV-infected infants ( 78.1 % vs 82.4 % , P = 0.418 ) .


Rapid PCR , versus an optimized standard care , increased the proportion of hospitalized HIV-infected infants initiating ART and reduced ART exposure in molecular test-negative infants , without meaningfully impacting time to ART initiation or follow-up rates .


A psychological disorder called ` Internet addiction ' has newly emerged along with a dramatic increase of worldwide Internet use .


However , few studies have used population-level samples nor taken into account contextual factors on Internet addiction .


We identified 57,857 middle and high school students ( 13-18 year olds ) from a Korean nationally representative survey , which was surveyed in 2009 .


To identify associated factors with addictive Internet use , two-level multilevel regression models were fitted with individual-level responses ( 1st level ) nested within schools ( 2nd level ) to estimate associations of individual and school characteristics simultaneously .


Gender differences of addictive Internet use were estimated with the regression model stratified by gender .


Significant associations were found between addictive Internet use and school grade , parental education , alcohol use , tobacco use , and substance use .


Female students in girls ' schools were more likely to use Internet addictively than those in coeducational schools .


Our results also revealed significant gender differences of addictive Internet use in its associated individual - and school-level factors .


Our results suggest that multilevel risk factors along with gender differences should be considered to protect adolescents from addictive Internet use .


Adherence to prescribed exercise is a challenge for cancer patients undergoing treatment .


The changing pattern of exercise adherence over time can not be fully understood by an overall measure of adherence .


This study was aimed to identify the trajectory of exercise adherence and its predictors for women with breast cancer during their chemotherapy .


Participants were 78 women with breast cancer assigned to the exercise arm of a randomized control trial .


Based on the weekly adherence rates in time and intensity , patients were classified as good ( > 100 % ) , acceptable ( 80-100 % ) , and poor ( < 80 % ) adherents .


Data were analyzed using ordinal logistic hierarchical linear modeling .


The trajectories for both time and intensity adherence declined significantly .


The decline in exercise-time adherence was significantly slower in women who reported higher interest in exercise .


Women with higher perceived importance of exercise , early disease stage , and employed were more likely to be classified as good intensity adherents .


Poorer weekly adherence for both exercise time and intensity was associated with higher fatigue level for that week .


Adherence to exercise adherence in breast cancer patients declined as the dose of exercise prescription increased .


Factors influencing overall adherence and adherence trend were identified .


Efavirenz is widely prescribed for HIV-1 infection .


Three polymorphisms in CYP2B6 define plasma efavirenz trough concentration strata that vary across an 10-fold range .


We characterized associations between human genetic polymorphisms and virologic response among participants who received efavirenz-containing regimens in a prospective clinical trial .


We genotyped 76 polymorphisms in CYP2B6 ( including those that define efavirenz concentration strata ) , CYP2A6 , CYP3A4 , CYP3A5 and ABCB1 and week 48 virologic responses in 360 Haitians who initiated efavirenz-containing regimens in protocol HT 001 .


Associations were characterized by logistic regression analysis and Fisher 's exact test .


Proportions with HIV-1 RNA < 50 or < 200 copies/mL did not differ across 10 CYP2B6 metabolizer strata .


In analyses that combined strata into three metabolizer levels ( extensive , intermediate and slow ) , the respective proportions were 0.79 , 0.79 and 0.81 ( < 50 copies/mL cut-off ) and 0.84 , 0.86 and 0.87 ( < 200 copies/mL cut-off ) .


Genetic associations were not identified after controlling for baseline variables or with other polymorphisms after adjusting for multiple comparisons .


Virologic failures in HT 001 were not explained by genetic polymorphisms known to define the lowest plasma efavirenz concentration stratum .


the aim of this study was to compare the effects of a functional tasks exercise programme to a cognitive training programme in older adults with mild cognitive impairment .


a single-blind randomised control trial with the intervention group compared with an active control group .


out-patient clinic .


older adults with mild cognitive impairment ( n = 83 ) aged 60 and older living in the community .


participants were randomised to either a functional task exercise group ( n = 43 ) or an active cognitive training group ( n = 40 ) for 10 weeks .


All outcome measures were undertaken at baseline , post-intervention and 6-month follow-up using Neurobehavioral Cognitive Status Examination , Trail Making Test , Chinese Version Verbal Learning Test , Category Verbal Learning Test , Lawton Instrumental Activities of Daily Living Scale and Problems in Everyday Living Test .


the functional task exercise group showed significant between-group differences in general cognitive functions , memory , executive function , functional status and everyday problem solving ability .


The improvements were sustained over time at 6-month follow-up .


a functional tasks exercise programme is feasible for improving cognitive functions and functional status of older adults with mild cognitive impairment .


This may serve as a cost-effective adjunct to the existing interventions for populations with mild cognitive impairment .


ACTRN12610001025022 .


The effect of proton pump inhibitors ( PPIs ) on the pharmacokinetics and pharmacodynamics of clopidogrel was assessed in two healthy volunteer crossover studies .


Study 1 : subjects received clopidogrel alone ( 300-mg loading dose , then 75 mg/day for 28 days ) and two of three PPIs ( omeprazole 80 mg , esomeprazole 40 mg or lansoprazole 60 mg ) plus clopidogrel for 29 days in three treatment periods ( randomized treatment sequence assignment ) .


Study 2 : subjects received clopidogrel alone ( 75 mg/day for 9 days ) and clopidogrel alone for 4 days followed by clopidogrel plus fixed-combination esomeprazole 20 mg/low-dose acetylsalicylic acid ( ASA ) 81 mg for 5 days in two treatment periods ( randomized treatment sequence assignment ) .


Pharmacokinetic effects were estimated by measuring active metabolite of clopidogrel , and pharmacodynamic effects by inhibition of adenosine diphosphate ( ADP ) - induced platelet aggregation .


There was a relative decrease of up to 50 % in exposure to the active metabolite of clopidogrel with the different PPIs ( study 1 ) , and close to 40 % with esomeprazole/low-dose ASA ( study 2 ) , compared with clopidogrel alone .


There was an absolute decrease of up to 17 % in inhibition of ADP-induced platelet aggregation with co-administration of different PPIs , compared with clopidogrel alone ; however , no differences in platelet inhibition were observed during co-administration with the esomeprazole/low-dose ASA fixed-dose combination .


Omeprazole , esomeprazole and lansoprazole decreased systemic exposure to the active metabolite of clopidogrel in healthy volunteers , leading to modest decreases in its antiplatelet effect .


However , no apparent differences in platelet inhibition were observed when esomeprazole was co-administered with low-dose ASA as a fixed-dose combination .


Despite their high rates of depression , homebound older adults have limited access to evidence-based psychotherapy .


The purpose of this paper was to report both depression and disability outcomes of telehealth problem-solving therapy ( tele-PST via Skype video call ) for low-income homebound older adults over 6 months postintervention .


A 3-arm randomized controlled trial compared the efficacy of tele-PST to in-person PST and telephone care calls with 158 homebound individuals who were aged 50 + and scored 15 + on the 24-item Hamilton Rating Scale for Depression ( HAMD ) .


Treatment effects on depression severity ( HAMD score ) and disability ( score on the WHO Disability Assessment Schedule [ WHODAS ] ) were analyzed using mixed-effects regression with random intercept models .


Possible reciprocal relationships between depression and disability were examined with a parallel-process latent growth curve model .


Both tele-PST and in-person PST were efficacious treatments for low-income homebound older adults ; however the effects of tele-PST on both depression and disability outcomes were sustained significantly longer than those of in-person PST .


Effect sizes ( dGMA-raw ) for HAMD score changes at 36 weeks were 0.68 for tele-PST and 0.20 for in-person PST .


Effect sizes for WHODAS score changes at 36 weeks were 0.47 for tele-PST and 0.25 for in-person PST .


The results also supported reciprocal and indirect effects between depression and disability outcomes .


The efficacy and potential low cost of tele-delivered psychotherapy show its potential for easy replication and sustainability to reach a large number of underserved older adults and improve their access to mental health services .


Steroids may improve outcomes in high-risk patients undergoing cardiac surgery with the use of cardiopulmonary bypass ( CBP ) .


There is a need \ for a large randomized controlled trial to clarify the effect of steroids in such patients .


We plan to randomize 7,500 patients with elevated European System for Cardiac Operative Risk Evaluation who are undergoing cardiac surgery with the use of CBP to methylprednisolone or placebo .


The first coprimary outcome is 30-day all-cause mortality , and the most second coprimary outcome is a composite of death , MI , stroke , renal failure , or respiratory failure within 30 days .


Other outcomes include a composite of MI or mortality at 30 days , new onset atrial fibrillation , bleeding and transfusion requirements , length of intensive care unit stay and hospital stay , infection , stroke , wound complications , gastrointestinal complications , delirium , postoperative insulin use and peak blood glucose , and all-cause mortality at 6 months .


As of October 22 , 2013 , 7,034 patients have been recruited into SIRS in 82 centers from 18 countries .


Patient 's mean age is 67.3 years , and 60.4 % are male .


The average European System for Cardiac Operative Risk Evaluation is 7.0 with 22.1 % having an isolated coronary artery bypass graft procedure , and 66.1 % having a valve procedure .


SIRS will lead to a better understanding of the safety and efficacy of prophylactic steroids for cardiac surgery requiring CBP .


Although multiple studies have suggested that repetitive transcranial magnetic stimulation ( rTMS ) may facilitate recovery after stroke , the efficacy of synchronous speech therapy integrated with an rTMS protocol has yet to be determined .


We investigated language responses to this strategy and determined the longevity of the resulting therapeutic outcomes .


Forty-five patients with stroke who presented with nonfluent aphasia were randomly assigned to the TMSsyn group and underwent synchronous picture-naming training together with contralesional 1 Hz-rTMS for 10 daily sessions .


The TMSsub group underwent subsequent picture-naming activity after the primed 1 Hz-rTMS , and the TMSsham group received concurrent naming task along with the sham 1 Hz-rTMS .


The Concise Chinese Aphasia test and the picture-naming test were performed before , immediately , and after 3 months of the intervention .


TMSsyn showed significantly superior results in Concise Chinese Aphasia test score ( P < 0.001 ) , expression and description subtests ( P < 0.001 ) , and action ( P = 0.02 ) and object naming activity ( P = 0.008 ) ; the superior results lasted for 3 months ( P = 0.005 ) , in comparison with the TMSsub and TMSsham groups .


We established a real-time model that involved implementing verbal tasks together with the rTMS protocol .


Our results confirmed that the strategy yielded favorable outcomes that were of considerable longevity .


The results also indicated that the rTMS protocol and language training can be combined to achieve outcomes superior to those obtained when used separately .


http://www.clinicaltrials.gov .


Unique identifier : NCT02120508 .


Traditional training of electroconvulsive therapy ( ECT ) consists of a combination of didactic and hands-on demonstrations using ECT equipment .


Our goal was to explore the potential of a high-fidelity patient simulator ( HPS ) to train these skills .


To our knowledge , this is the first time an HPS has been used for skills training in psychiatry .


Nineteen psychiatry residents participated in this randomized controlled trial to compare traditional training ( n = 9 ) versus training using an HPS ( n = 10 ) .


Two blinded raters assessed performance using a newly developed checklist and global rating scale for this task ( ECT-OSATS ) ( Objective Structured Assessment of Technical Skills ) .


Residents also completed a pretest-posttest knowledge test and confidence survey .


Residents in the HPS group performed significantly better in terms of ECT-OSATS when compared with the control group ( P < 0.001 ) .


All 10 of the HPS group received a `` pass '' rating following training , whereas only 1 of the 9 control group received a `` pass '' rating .


There were no significant group differences in posttest confidence ( P = 0.21 ) or total knowledge gain scores from pretest to posttest ( P = 0.36 ) .


The level of clinical skill acquired by trainees in psychiatry for performing ECT is significantly superior using HPS - based training , in contrast to the domains of knowledge and confidence , which appear to be equally imparted using either training modality .


The acquisition of skills in administering ECT seems to be an independent variable in relation to a clinician 's level of knowledge and confidence in performing ECT .


To compare the advantages of prolotherapy in the treatment of first carpometacarpal osteoarthritis ( OA ) with those of corticosteroid local injection in the short and long term .


We performed a randomized controlled trial from March 2010 to March 2011 in an outpatient clinic at a university hospital .


Sixty participants ( 60 hands ) with OA of the first carpometacarpal joint were assigned equally to two groups .


For the corticosteroid group , after 2 monthly saline placebo injections , a single dose of 40 mg methylprednisolone acetate ( 0.5 ml ) mixed with 0.5 ml of 2 % lidocaine was injected .


For the dextrose ( DX ) group , 0.5 ml of 20 % DX was mixed with 0.5 ml of 2 % lidocaine and the injection was repeated monthly for 3 months .


Pain intensity , hand function and the strength of lateral pinch grip were measured at the baseline and at 1 , 2 , and 6 months after the treatment .


Mean age ( STD ) was 63.6 ( 9.7 ) years , and mean ( STD ) visual analog scale ( VAS ) was 6 ( 2 ) .


The two groups were comparable at 2 months , but significantly different at 1 month , with better results for corticosteroid , and at 6 months with apparently more favorable outcome for DX [ mean difference ( 95 % CI ) in VAS = 1.1 ( 0.2 , 2.0 ) , p = 0.02 ] .


After 6 months of treatment , both DX and corticosteroid injection increased functional level , but DX seemed to be more effective [ mean difference ( 95 % CI ) in total function score = 1.0 ( 0.2 , 1.8 ) , p = 0.01 ] .


For the long term , DX seems to be more advantageous , while the two treatments were comparable in the short term .


Because of the satisfactory pain relief and restoring of function , we would prefer DX prolotherapy for the treatment of patients with OA .


Therapeutic studies -- investigating the results of treatment ; level I.


QT assessment of oncology drugs is generally challenging because they are genotoxic and , of necessity , they require multisite evaluation in cancer patients .


Lenvatinib is not genotoxic , therefore , this thorough QT ( TQT ) study with lenvatinib , a multityrosine kinase inhibitor , was undertaken utilizing healthy volunteers and concentration effect modeling to project the TQT effect at high plasma levels .


Fifty-two healthy subjects randomly received single doses of lenvatinib 32 mg , placebo , or moxifloxacin 400 mg in a three-way crossover study .


Serial electrocardiograms were recorded , and the effect on placebo corrected change-from-baseline QTcF ( QTcF ) was evaluated .


The relationship between lenvatinib plasma concentrations and QTcF was analyzed with linear mixed effects modeling .


L envatinib mildly lowered the heart rate by 58 bpm during the first 12 h after dosing .


QTcF was shortened with a peak effect of 5.72 ms ( 90 % confidence interval ( 90 % CI ) 7.76 to 3.69 ms ) at 6 h postdosing.The upper bound of mean QTcF did not exceed 2 ms at any time point postdosing .


A concentration-dependent effect of lenvatinib on QTcF was identified with an estimated population intercept of 2.96 ms ( 90 % CI 4.49 to1 .43 ms ; P = 0.0016 ) and a negative slope of 0.0045 ( 90 % CI 4.49 to 1.43 ) ms per ng/mL , respectively .


The safety profile after a single dose of lenvatinib was acceptable , with adverse events ( AEs ) of mild-to-moderate severity and no serious AEs .


L envatinib had no clinically relevant effect on the QTc interval .


Concentration-effect modeling supports the lack of QTc prolongation at high plasma concentrations .


Low 25-hydroxyvitamin D levels are common in patients with primary hyperparathyroidism ( PHPT ) and associated with higher PTH levels and hungry bone syndrome after parathyroidectomy ( PTX ) .


However , concerns have been raised about the safety of vitamin D supplementation in PHPT .


We aimed to assess safety and effects on calcium homeostasis and bone metabolism of supplementation with high doses of vitamin D in PHPT patients .


This was an investigator-initiated double-blind , randomized , placebo-controlled , parallel-group trial from a single center .


Forty-six PHPT patients were recruited , with a mean age of 58 ( range 29-77 ) years , and 35 ( 76 % ) were women .


Intervention included daily supplementation with 70 g ( 2800 IU ) cholecalciferol or identical placebo for 52 weeks .


Treatment was administered 26 weeks before PTX and continued for 26 weeks after PTX .


PTH , calcium homeostasis , and bone metabolism were evaluated .


Preoperatively , 25-hydroxyvitamin D increased from 50 to 94 nmol/L in the treatment group and decreased from 57 to 52 nmol/L in the placebo group ( P < .001 ) .


Compared with placebo , vitamin D decreased PTH significantly by 17 % before PTX ( P = .01 ) , increased lumbar spine bone mineral density by 2.5 % ( P = .01 ) , and decreased C-terminal - CrossLaps by 22 % ( P < .005 ) .


The trabecular bone score did not change in response to treatment , but improved after PTX .


Postoperatively , PTH remained lower in the cholecalciferol group compared with the placebo group ( P = .04 ) .


Plasma creatinine and plasma and urinary calcium did not differ between groups .


Daily supplementation with a high vitamin D dose safely improves vitamin D status and decreases PTH in PHPT patients .


The vitamin D treatment is accompanied by reduced bone resorption and improved bone mineral density before operation .


In line with a rapidly ageing global population , the rise in the frequency of falls will lead to increased healthcare and social care costs .


This study will be one of the few randomized controlled trials evaluating a multifaceted falls intervention in a low-middle income , culturally-diverse older Asian community .


The primary objective of our paper is to evaluate whether individually tailored multifactorial interventions will successfully reduce the number of falls among older adults .


Three hundred community-dwelling older Malaysian adults with a history of ( i ) two or more falls , or ( ii ) one injurious fall in the past 12 months will be recruited .


Baseline assessment will include cardiovascular , frailty , fracture risk , psychological factors , gait and balance , activities of daily living and visual assessments .


Fallers will be randomized into 2 groups : to receive tailored multifactorial interventions ( intervention group ) ; or given lifestyle advice with continued conventional care ( control group ) .


Multifactorial interventions will target 6 specific risk factors .


All participants will be re-assessed after 12 months .


The primary outcome measure will be fall recurrence , measured with monthly falls diaries .


Secondary outcomes include falls risk factors ; and psychological measures including fear of falling , and quality of life .


Previous studies evaluating multifactorial interventions in falls have reported variable outcomes .


Given likely cultural , personal , lifestyle and health service differences in Asian countries , it is vital that individually-tailored multifaceted interventions are evaluated in an Asian population to determine applicability of these interventions in our setting .


If successful , these approaches have the potential for widespread application in geriatric healthcare services , will reduce the projected escalation of falls and fall-related injuries , and improve the quality of life of our older community .


ISRCTN11674947 .


The purpose of the present study was to compare the effects of equal-volume resistance training ( RT ) performed once or twice a week on muscle mass and strength of the elbow flexors in untrained young men .


Thirty men ( 23 3 years ) without previous resistance training experience were divided into two groups : Group 1 ( G1 ) trained each muscle group only once a week and group 2 ( G2 ) trained each muscle twice a week during 10 weeks .


Baseline and 10 weeks post-test elbow flexors muscle thickness ( MT ) were measured using a B-Mode ultrasound .


Peak torque ( PT ) was assessed by an isokinetic dynamometer before and after the training program .


Elbow flexors MT increased significantly ( P < 0.05 ) from 31.70 3.31 to 33.43 3.46 mm in G1 , and from 32.78 4.03 to 35.09 3.55 mm in G2 .


Elbow flexors PT also increased ( P < 0.05 ) from 50.77 9.26 to 54.15 10.79 N.m in G1 , and from 48.99 11.52 to 55.29 10.24 N.m in G2 .


The results of ANOVA did not reveal group by time interactions for any variable , indicating no difference between groups for the changes in MT or PT .


The results from the present study suggest that untrained men experience similar gains in muscle mass and strength with equal volume RT performed one or two days per week .


The introduction of new medical devices may be accompanied by a learning curve .


To evaluate the impact of the device learning curve on the outcomes of PROTECT II trial , comparing Impella 2.5 versus the intra-aortic balloon pump ( IABP ) during high-risk percutaneous coronary intervention , we report on a prespecified analysis , excluding the first Impella 2.5 and IABP patients at each site .


A total of 448 patients were enrolled at 74 sites .


Among these , 58 patients were the first to receive Impella 2.5 at their site , 62 were the first to receive IABP .


A trend toward higher major adverse events ( MAEs ) at 30 days was observed for the subgroup of first versus remaining Impella 2.5 patients : 44.8 % versus 31.7 % , P = .072 .


MAE rates for the first and remaining IABP patients were similar at 30 days .


After exclusion of the first patient in each group , MAE rates for Impella 2.5 and IABP were 31.7 % versus 40.0 % ( P = .119 ) at 30 days and 38.0 % versus 50.0 % ( P = .029 ) at 90 days .


Significantly lower 90-day MAE rates were observed with the use of Impella 2.5 compared to the use of IABP after excluding the first patient per group at each site .


This prespecified analysis suggests a learning curve associated with initial introduction of the Impella 2.5 .


Clinical trials should better address the training aspect of new devices , especially when compared with more established devices .


One-lung ventilation ( OLV ) is accomplished with a double-lumen tube ( DLT ) or a bronchial blocker ( BB ) .


The authors compared the effectiveness of lung collapse using DLT , BB , and BB with the disconnection technique .


Prospective , randomized , blind trial .


A university hospital .


Fifty-two patients undergoing elective pneumothorax surgery .


Patients were assigned randomly to 1 of 3 groups : The DLT group ( group 1 ) , the BB group ( group 2 ) , and the BB with the disconnection technique group ( group 3 ) .


The authors modified the disconnection technique in group 3 as follows : ( 1 ) turned off the ventilator and opened the adjustable pressure-limiting valve , allowing both lungs to collapse and ( 2 ) after loss of the CO2 trace on the capnograph , inflated the blocker cuff and turned on the ventilator , allowing only dependent-lung ventilation .


Five and ten minutes after OLV , the degree of lung collapse was assessed by the surgeon , who was blinded to the isolation technique .


The quality of lung collapse at 5 and 10 minutes was significantly better in groups 1 and 3 than in group 2 .


No significant differences were observed for the degree of lung collapse at any time point between groups 1 and 3 .


The average time for loss of the CO2 trace on the capnograph was 32.37.0 seconds in group 3 .


A BB with spontaneous collapse took longer to deflate and did not provide equivalent surgical exposure to the DLT .


The disconnection technique could be helpful to accelerate lung collapse with a BB .


To compare levels of diabetes distress in people with Type 2 diabetes treated in primary and secondary care and to examine demographic and clinical correlates that may explain potential differences in levels of distress between care settings .


People with Type 2 diabetes from 24 primary care practices ( n = 774 ) and three secondary care clinics ( n = 526 ) completed the Problem Areas In Diabetes questionnaire .


Data on HbA1c levels and diabetes complications were derived from medical charts .


Hierarchical ordinal regression analysis was used to investigate which correlates could explain the potential differences in level of diabetes distress between care settings .


Diabetes distress levels and the prevalence of elevated diabetes distress were considerably lower in the participants treated in primary care ( mean ( SD ) total diabetes distress score 8 ( 11 ) ; 4 % of participants with a Problem Areas In Diabetes score 40 ) than in secondary care ( mean ( SD ) total diabetes distress score 23 ( 21 ) ; 19 % of participants with a Problem Areas In Diabetes score 40 , P < 0.001 ) .


In addition to care setting , the following variables were also independently related to diabetes distress : younger age , ethnic minority status , using insulin , having a higher HbA1c level , having a higher BMI and the presence of neuropathy .


Other diabetes complications were not independently associated with diabetes distress .


In primary care , lower levels of diabetes distress were reported than in secondary care .


The difference in diabetes distress between care settings can be largely , but not fully , explained by specific demographic and clinical characteristics .


These results need to be interpreted with caution as they are based on two separate studies , but do call into question the need to screen for diabetes distress in people with Type 2 diabetes in primary care .


This randomized , double-blind , parallel-group clinical trial aims to assess the equivalence of intra-articular polynucleotides compared to standard hyaluronic acid ( HA ) viscosupplementation in the treatment of knee osteoarthritis ( OA ) .


75 patients affected by knee OA were assessed for eligibility and 72 were enrolled and randomized to receive either intra-articular polynucleotides ( Condrotide-36 patients ) or hyaluronic acid ( Hyalubrix-36 patients ) at the Orthopedic Institute `` Gaetano Pini '' ( Milan ) .


All patients underwent three intra-articular injections of Condrotide or Hyalubrix with an interval of 1week .


Participants , care givers , and investigators responsible for outcome assessment were all blinded to group assignment .


Primary outcome measurements ( KOOS and pain level ( 1 ) at rest , ( 2 ) at weight-bearing and ( 3 ) during physical activity ) were evaluated at baseline ( T0 ) and after one ( T1 ) , two ( T2 ) , six ( T6 ) , ten ( T10 ) , and 26 ( T26 ) weeks .


Secondary measurements included the determination of COMP serum levels at T0 , T6 and T26 .


The reduction of pain and the increase of KOOS values from baseline were statistically significant for both treatments ; nevertheless , for parameter KOOS `` symptoms '' the treatment with Condrotide showed significant results already after twoweeks ( at T2 p = 0.003 ) while the results obtained with Hyalubrix became significant only after 18 weeks ( at T18 p = 0.01 ) .


No significant adverse events were reported .


Condrotide is as effective as Hyalubrix in reducing knee OA symptoms but showed an earlier response on pain reduction and can therefore be considered a valid alternative to the use of HA in the treatment of OA , avoiding the adverse events of NSAIDs and of intra-articular corticosteroids .


To develop a multivariable prognostic model for the risk of preterm delivery in women with multiple pregnancy that includes cervical length measurement at 16 to 21 weeks ' gestation and other variables .


We used data from a previous randomized trial .


We assessed the association between maternal and pregnancy characteristics including cervical length measurement at 16 to 21 weeks ' gestation and time to delivery using multivariable Cox regression modelling .


Performance of the final model was assessed for the outcomes of preterm and very preterm delivery using calibration and discrimination measures .


We studied 507 women , of whom 270 ( 53 % ) delivered < 37 weeks ( preterm ) and 66 ( 13 % ) < 32 weeks ( very preterm ) .


Women with cervical length < 30 mm delivered more often preterm ( hazard ratio 1.9 ; 95 % CI 0.7 to 4.8 ) .


Other independently contributing predictors were previous preterm delivery , monochorionicity , smoking , educational level , and triplet pregnancy .


Prediction models for preterm and very preterm delivery had a c-index of 0.68 ( 95 % CI 0.63 to 0.72 ) and 0.68 ( 95 % CI 0.62 to 0.75 ) , respectively , and showed good calibration .


In women with a multiple pregnancy , the risk of preterm delivery can be assessed with a multivariable model incorporating cervical length and other predictors .


Dietary sodium loading has been shown to adversely impact endothelial function independently of blood pressure ( BP ) .


However , it is unknown whether dietary sodium loading impacts endothelial function differently in men as compared to women .


The aim of this study was to test the hypothesis that endothelial-dependent dilation ( EDD ) would be lower in men as compared to women in response to a high sodium diet .


Thirty subjects ( 14F , 312y ; 16M , 292y ) underwent a randomized , crossover , controlled diet study consisting of 7 days of low sodium ( LS ; 20 mmol/day ) and 7 days of high sodium ( HS ; 300-350 mmol/day ) .


Salt-resistance was determined by a change in 24-hr mean arterial pressure ( MAP ) 5 mm Hg between HS and LS as assessed on day 7 of each diet .


Blood and 24-hr urine were also collected and EDD was assessed by brachial artery flow-mediated dilation ( FMD ) .


By design , MAP was not different between LS and HS conditions and urinary sodium excretion increased on HS diet ( P < 0.01 ) .


FMD did not differ between men and women on the LS diet ( 10.2 0.65 vs. 10.7 0.83 ; P > 0.05 ) and declined in both men and women on HS ( P < 0.001 ) .


However , FMD was lower in men as compared to women on HS ( 5.7 0.5 vs. 8.6 0.86 ; P < 0.01 ) .


HS reduced FMD in both men and women .


In response to an HS diet , FMD was lower in men compared to women suggesting a greater sensitivity of the vasculature to high sodium in men .


We assessed the efficacy of onabotulinumtoxinA ( BOTOX , Allergan Inc. , Irvine , CA , USA ) in patients with refractory overactive bladder ( OAB ) after treatment for benign prostatic hyperplasia ( BPH ) .


This was a two-center , randomized , double-blinded pilot study conducted in patients with OAB secondary to bladder outlet obstruction ( BOO ) , refractory to anticholinergic medication and persistent for greater than 3 months after surgical intervention to relieve obstruction , with an International Prostate Symptom Score ( IPSS ) > 12 .


Patients were randomized in 1:1 fashion to either 200 units of onabotulinumtoxinA versus placebo .


Fifteen patients received onabotulinumtoxinA versus 13 who received placebo .


Follow up was performed at 1 week and then 1 , 3 , 6 , and 9 months .


The primary endpoint was reduction in the frequency of micturition per 24 hours by 3-day voiding diary .


Secondary endpoints were maximum flow rate ( Qmax ) , post-void residual ( PVR ) , and IPSS scores .


Patients receiving onabotulinumtoxinA demonstrated significantly improved quality of life scores at 180 and 270 days after treatment ( p = 0.02 and 0.03 , respectively ) as well as significantly lower International Consultation on Incontinence Questionnaire ( ICIQ ) scores ( p < 0.05 ) .


Baseline urinary frequency was 10.5 versus 11.0 voids/day ( p = 0.47 ) .


Frequency episodes improved from 11 episodes per day to 8 episodes per day in the treatment arm .


The placebo arm did not have a decrease in frequency episodes .


This response was durable up to 90 days , although this was not statistically significant .


IPSS , PVR , and urgency were unchanged postoperatively in both groups .


OnabotulinumtoxinA was safe in patients with refractory irritative lower urinary tracts symptoms after surgical treatment of BPH .


There were improvements in daily frequency , although the results were not statistically significant .


Larger trials are needed to help characterize the utility of onabotulinumtoxinA in the treatment of OAB secondary to BPH .


The aim of the study was to assess the hemodynamic and metabolic actions of estrogen plus progestin therapy ( EPT ) in hypertensive , postmenopausal women treated with perindopril ( ACEI ) or hydrochlorothiazide ( HCTZ ) .


A group of normotensive postmenopausal women was also studied .


100 hypertensive and 40 normotensive postmenopausal women were recruited for the study .


The hypertensive females were randomly assigned to receive ACEI or HCTZ for 12months .


The patients of the ACEI group and the patients of the HCTZ group , as well as normotensives , were further subdivided into two subgroups each .


One subgroup received estrogen plus progestin therapy ( EPT + ) , the other subgroup received no hormone replacement ( EPT - ) .


Combined hormone replacement with transdermal patches releasing 17-estradiol and norethisterone was used .


Office and 24-hour ambulatory blood pressure was measured at baseline and during follow-up .


Renal plasma flow ( RPF ) was measured using the clearance of [ 125I ] - iodohippuran .


Pulse wave velocity ( PWV ) was determined with an automatic device .


In normotensive postmenopausal women , transdermal estrogen plus progestin therapy increases RPF and insulin sensitivity , decreases PWV , decreases total and LDL cholesterol , and decreases uric acid serum levels .


Perindopril ( 4mg/day ) and hydrochlorothiazide ( 25mg/day ) were equally effective in reducing blood pressure in postmenopausal , hypertensive subjects .


In these females , perindopril increased RPF and decreased PWV and plasma insulin levels .


These effects of the ACEI were not altered by estrogen plus progestin therapy .


Hydrochlorothiazide decreased RPF and increased plasma insulin and uric acid concentrations in hypertensive subjects whom were not receiving estrogen plus progestin therapy .


The unfavorable metabolic and hemodynamic actions of the diuretic were counteracted by estrogen plus progestin therapy .


Concomitant estrogen plus progestin therapy may be a method to avoid unfavorable hemodynamic and metabolic effects of thiazide diuretics in hypertensive , postmenopausal women .


Distal radius fractures in young , working-age patients are frequent and are associated with potential disability in case of inappropriate treatment .


Our hypothesis is that there is no difference between patients treated with a volar plate and those treated with closed reduction and external fixation .


We studied 69 patients with complex distal radius fractures .


They were prospectively and randomly assigned to treatment with a volar plate or an external fixator : they were followed-up and assessed at one year using two scales , the Visual Analog Scale ( VAS ) and the McDermid et al. .


Functionality Scale .


Both groups showed good results at one year .


Measurements in the pain Visual Analog Scale and disability measured with the McDermid et al. scale were not statistically significant .


Higher scores mean greater disability .


Scores above 20 were considered as failures .


We found 2 cases with complications in the F group ; one with material dislodgement and one with malunion , without significant differences .


Both treatments show good results in the medium-term ; no differences were found between both groups regarding pain and residual disability .


Complications were few and they were addressed conservatively ; they were less frequent with open reduction and internal fixation .


When ranges of motion and the complication rate were compared , the volar plate showed a statistically significant difference in a decreased complication risk .


To determine whether Asian and white subjects differ in clinical signs or subjective symptoms in response to the use of different biguanide-preserved contact lens care solutions .


Forty-two subjects ( 15 Asian and 27 white ) wearing lotrafilcon B silicone hydrogel contact lenses used a preservative-free lens care solution bilaterally for 2 weeks , then used two biguanide-preserved solutions ( solution 1 : ReNu MPS ; solution 2 : AQuify MPS ) contralaterally in randomly assigned eyes for 4 weeks .


Comprehensive ocular surface examinations were performed and symptomatology questionnaires were administered every 2 weeks .


Investigators were masked as to solution assignment during examinations , whereas subjects were not to avoid potential difficulties in compliance with the protocol .


With solution 1 , most Asian and white subjects had grade 2 or greater corneal staining after 2 weeks ( 67 % and 59 % , respectively ) and 4 weeks ( 60 % and 67 % , respectively ) .


With solution 2 , grade 2 or greater corneal staining occurred in 40 % of Asians after 2 weeks and in 13 % after 4 weeks , but in only 4 % of whites after 2 weeks and 0 % after 4 weeks .