The study was conducted at a university hospital in Karachi , Pakistan .


The study was a single-center , open-label , randomized , controlled trial of routine care ( group A , 200 mg ferrous sulfate and 600 mg calcium daily ) vs vitD supplementation ( group B , 4000 IU vitamin D3 daily ) , started at 20 weeks and continued till delivery .


Maternal serum samples of 25-hydroxyvitamin D ( 25OHD ) were collected at baseline and delivery .


Neonatal vitD status was assessed in cord blood or in neonatal serum samples within 48 hours of birth .


Obstetric outcomes included gestational hypertension , gestational diabetes , and preterm labor , and neonatal well-being included small for gestational age , birth weight , length , head circumference , and 1 - and 5-minute Apgar scores .


Of 207 gravidae enrolled , 193 completed the trial .


Maternal age , vitD status , and gestational age at enrollment were comparable between the two groups .


At delivery , maternal 25OHD was increased in group B ( 18.3 11 ng/dL vs 8.82 11.84 ng/dL ( P = .001 ) compared with group A ( 6.9 7.0 ng/dL vs 6.32 3.97 ng/dL , P = .06 ) .


The obstetric outcomes were comparable between the two groups ( P > .05 ) .


Neonatal 25OHD levels were significantly higher in group B compared with group A ( 19.22 12.19 ng/dL vs 6.27 5.2 ng/dL ) .


There was positive correlation between maternal and neonatal 25OHD levels ( r = 0.83 , P = .001 ) .


One - and 5-minute Apgar scores were significantly higher in group B ( 7.10 0.66 vs 6.90 0.50 , P = .026 , and 8.53 0.68 vs 8.33 0.81 , P = .051 , respectively ) .


Neonatal anthropometric parameters were comparable between the two groups ( P > .05 ) .


Maternal vitD supplementation improved maternal and neonatal vitD status .


Although caloric restriction is a widely used intervention to reduce body weight and insulin resistance , many patients are unable to comply with such dietary therapy for long periods .


The clinical effectiveness of low-carbohydrate diets was recently described in a position statement of Diabetes UK and a scientific review conducted by the American Diabetes Association .


However , randomised trials of dietary interventions in Japanese patients with type 2 diabetes are scarce .


Therefore , the aim of this study was to examine the effects of a non-calorie-restricted , low-carbohydrate diet in Japanese patients unable to adhere to a calorie-restricted diet .


The enrolled patients were randomly allocated to receive a conventional calorie-restricted diet or low-carbohydrate diet .


The patients received consultations every two months from a registered dietician for six months .


We compared the effects of the two dietary interventions on glycaemic control and metabolic profiles .


The HbA1c levels decreased significantly from baseline to six months in the low-carbohydrate diet group ( baseline 7.60.4 % , six months 7.00.7 % , p = 0.03 ) but not in the calorie-restricted group ( baseline 7.70.6 % , six months 7.51.0 % , n.s. ) , ( between-group comparison , p = 0.03 ) .


The patients in the former group also experienced improvements in their triglyceride levels , without experiencing any major adverse effects or a decline in the quality of life .


Our findings suggest that a low-carbohydrate diet is effective in lowering the HbA1c and triglyceride levels in patients with type 2 diabetes who are unable to adhere to a calorie-restricted diet .


A randomized controlled clinical trial was implemented to evaluate the effectiveness of combined mild hyperthermia therapy ( body core temperature 38.4 C ) and multimodal inpatient rehabilitation for patients suffering from chronic low back pain when compared to multimodal pain therapy alone .


A total of 88patients were randomly assigned to the combined or single therapeutic schemes according to a block randomization scheme .


According to the trial inclusion criteria all patients suffered from chronic low back pain and showed morphological degeneration .


All patients underwent a 12-day inpatient multimodal pain therapy , which was complemented with a 6-session schedule of mild hyperthermia therapy for the intervention group ( 1h at 38.6 C ) .


On admission and 3months after treatment the study patients were asked to complete an interview assessment with the Oswestry low back pain disability questionnaire ( Oswestry disability index ) .


The change in the Oswestry disability index total score ( % ) 3months after versus before therapy was defined as the primary clinical endpoint of the investigation .


The patients in the control group and in the intervention group had a median age of 50years .


In the intervention group 70 % of the patients were female and 55 % reported having half to full time employment compared to 55 % and 43 % in the control group , respectively .


On admission the control patients reported a median Oswestry disability index of 64 % and on recall the same of 64 % .


The intervention group showed median Oswestry disability index estimates of 60 % and 66 % , respectively .


The changes in the overall Oswestry disability index after 3months differed significantly with an estimated 6 % for the intervention group versus 0 % for the control group ( Wilcoxon p = 0.050 ) .


When combined with a multimodal inpatient lower back pain functional therapy in patients showing morphological degeneration , the mild hyperthermia therapy demonstrated statistically significant , although not clinically relevant benefits in comparison to the multimodal treatment alone .


However , regarding the moderate overall patient-related benefits as measured in terms of the Oswestry disability index , the benefit of the underlying multimodal therapy concept implementation must be critically discussed irrespective of its combination with mild hyperthermia therapy .


Probiotics have treatment efficacy in irritable bowel syndrome ( IBS ) , but the exact mechanism remains obscure .


One hypothesis is the mediation of melatonin levels , leading to changes in IBS symptoms .


The purpose of this study was to evaluate the effects of a probiotic , VSL # 3 , on symptoms , psychological and sleep parameters , and pain sensitivity in IBS , and relate these parameters to in vivo melatonin levels .


Forty-two IBS patients were randomly assigned to receive VSL # 3 or placebo for 6 weeks .


Subjects completed bowel and psychological questionnaires , underwent rectal sensitivity testing and saliva melatonin assays .


Abdominal pain duration and distension intensity decreased significantly in the probiotic group , along with an increase in rectal distension pain thresholds .


A correlation between increase in pain tolerance and improvement in abdominal pain scores ( r = 0.51 , p = 0.02 ) was seen with probiotic .


There was an increase in salivary morning melatonin levels in males treated with VSL # 3 , which correlated ( r = 0.61 ) with improved satisfaction in bowel habits .


When grouped based on baseline diurnal melatonin levels , patients with normal diurnal fluctuations showed an increase in morning melatonin levels with VSL # 3 treatment , which significantly correlated with improved satisfaction in bowel habits ( r = 0.68 ) .


They also had reduced symptom severity scores and abdominal pain duration when treated with VSL # 3 , as well as satisfaction with bowel movements and quality-of-life .


VSL # 3 improved symptoms and increased rectal pain thresholds .


Symptom improvement correlated with a rise in morning melatonin , significant in males and subjects with normal circadian rhythm .


This suggests that probiotics may act by influencing melatonin production , hence modulating IBS symptoms , in individuals with a normal circadian rhythm .


Charcot-Marie-Tooth type 1A disease ( CMT1A ) is a rare orphan inherited neuropathy caused by an autosomal dominant duplication of a gene encoding for the structural myelin protein PMP22 , which induces abnormal Schwann cell differentiation and dysmyelination , eventually leading to axonal suffering then loss and muscle wasting .


We favour the idea that diseases can be more efficiently treated when targeting multiple disease-relevant pathways .


In CMT1A patients , we therefore tested the potential of PXT3003 , a low-dose combination of three already approved compounds ( baclofen , naltrexone and sorbitol ) .


Our study conceptually builds on preclinical experiments highlighting a pleiotropic mechanism of action that includes downregulation of PMP22 .


The primary objective was to assess safety and tolerability of PXT3003 .


The secondary objective aimed at an exploratory analysis of efficacy of PXT3003 in CMT1A , to be used for designing next clinical development stages ( Phase 2b/3 ) .


80 adult patients with mild-to-moderate CMT1A received in double-blind for 1 year Placebo or one of the three increasing doses of PXT3003 tested , in four equal groups .


Safety and tolerability were assessed with the incidence of related adverse events .


Efficacy was assessed using the Charcot-Marie-Tooth Neuropathy Score ( CMTNS ) and the Overall Neuropathy Limitations Scale ( ONLS ) as main endpoints , as well as various clinical and electrophysiological outcomes .


This trial confirmed the safety and tolerability of PXT3003 .


The highest dose ( HD ) showed consistent evidence of improvement beyond stabilization .


CMTNS and ONLS , with a significant improvement of respectively of 8 % ( 0.4 % - 16.2 % ) and 12.1 % ( 2 % - 23.2 % ) in the HD group versus the pool of all other groups , appear to be the most sensitive clinical endpoints to treatment despite their quasi-stability over one year under Placebo .


Patients who did not deteriorate over one year were significantly more frequent in the HD group .


These results confirm that PXT3003 deserves further investigation in adults and could greatly benefit CMT1A-diagnosed children , usually less affected than adults .


EudraCT Number : 2010-023097-40 .


ClinicalTrials.gov Identifier : NCT01401257 .


The Committee for Orphan Medicinal Products issued in February 2014 a positive opinion on the application for orphan designation for PXT3003 ( EMA/OD/193 / 13 ) .


NaCl 7.2 % / 6 % hydroxyethyl starch ( HES ) 200/0 .5 ( HSH ) has shown its beneficial effects in cardiac surgery and immunomodulatory values in experiment and human studies .


However , there is concern regarding detrimental renal effects of chloride and HES in the intensive care setting .


The objective of this study was to evaluate the influence of HSH on kidney integrity and the level of inflammatory mediators in on-pump coronary artery bypass surgery patients .


This was a single-center , prospective , randomized , single-blind pilot study .


This work was performed at a tertiary cardiothoracic referral center during the period from February to August 2012 .


Forty patients scheduled for on-pump coronary artery bypass surgery were included .


PATIENTS were randomized to receive once either 7.2 % NaCl/6 % HES 200/0 .5 ( HSH group , n = 20 ) or placebo ( 0.9 % NaCl ; control group , n = 20 ) at a dose of 4 mLkg for 30 min after anesthesia induction .


The primary end point was the incidence of acute kidney injury ( AKI ) defined according to the Kidney Disease : Improving Global Outcomes .


Secondary end points were peak serum cystatin C , peak urine neutrophil gelatinase-associated lipocalin , plasma levels of interleukin 6 ( IL-6 ) , IL-10 , intercellular adhesion molecule 1 , and endothelial-leukocyte adhesion molecule ( E-selectin ) .


The incidence of AKI within 48 h was similar between the groups ( HSH : four patients [ 20 % ] ; control : six patients [ 30 % ] ) .


There was a significantly lower peak value for serum cystatin C in the HSH group ( 0.83 [ 0.73-0 .89 ] mgL ) compared with the control group ( 1.02 [ 0.88-1 .15 ] mgL ; P = 0.001 ) .


PATIENTS in both groups had similar peak postoperative urine neutrophil gelatinase-associated lipocalin concentrations .


NaCl 7.2 % / 6 % hydroxyethyl starch 200/0 .5 significantly reduces levels of IL-6 and IL-10 at 4 h after cardiopulmonary bypass and intercellular adhesion molecule 1 and E-selectin at 4 h after cardiopulmonary bypass and on postoperative day 1 ( P < 0.05 for all ) .


NaCl 7.2 % / 6 % hydroxyethyl starch 200/0 .5 does not lead to the increase in AKI incidence when used for the volume therapy in on-pump coronary artery bypass surgery patients .


NaCl 7.2 % / 6 % hydroxyethyl starch 200/0 .5 usage enhanced neither tubular injury nor alteration of glomerular filtration .


In addition , HSH can reduce the level of the inflammatory mediators after surgery .


To compare ondansetron with metoclopramide in the treatment of hyperemesis gravidarum .


We enrolled 160 women with hyperemesis gravidarum in a double-blind randomized trial .


Participants were randomized to intravenous 4 mg ondansetron or 10 mg metoclopramide every 8 hours for 24 hours .


Participants kept an emesis diary for 24 hours ; at 24 hours , they expressed their well-being using a 10-point visual numeric rating scale and answered an adverse effects questionnaire .


Nausea intensity was evaluated using a 10-point visual numeric rating scale at enrollment and at 8 , 16 , and 24 hours .


Primary analysis was on an intention-to-treat basis .


Eighty women each were randomized to ondansetron or metoclopramide .


Median well-being visual numeric rating scale scores were 9 ( range , 5-10 ) compared with 9 ( range , 4-10 ) ( P = .33 ) and vomiting episodes in the first 24 hours were 1 ( range , 0-9 ) compared with 2 ( range , 0-23 ) ( P = .38 ) for ondansetron compared with metoclopramide , respectively .


Repeat-measures analysis of variance of nausea visual numeric rating scale showed no difference between study drugs ( P = .22 ) .


Reported rates of drowsiness ( 12.5 % compared with 30 % ; P = .01 ; number needed to treat to benefit , 6 ) , xerostomia ( 10.0 % compared with 23.8 % ; P < .01 ; number needed to treat to benefit , 8 ) , and persistent ketonuria at 24 hours ( 12.5 % compared with 30 % ; P = .01 ; number needed to treat to benefit , 6 ) were less frequent with ondansetron .


Length of hospital stay was similar .


Ondansetron and metoclopramide demonstrated similar antiemetic and antinauseant effects in hyperemesis gravidarum .


However , the overall profile , particularly regarding adverse effects , was better with ondansetron .


In our setting , metoclopramide was significantly less expensive than ondansetron and remained a reasonable antiemetic choice .


ISRCN Register , www.isrctn.org , ISRCTN00592566 .


I.


To evaluate once-daily nepafenac 0.3 % to prevent and treat ocular pain and inflammation after cataract surgery .


Sixty-five centers in the United States and Europe .


Randomized double-masked vehicle - and active-controlled phase 3 study .


Patients received nepafenac 0.3 % once daily , nepafenac 0.1 % 3 times daily , or their respective vehicles from day -1 to day 14 after cataract extraction .


An additional drop of study drug was administered 30 to 120 minutes preoperatively .


The primary endpoint was the percentage of patients with a cure for inflammation ( score of 0 for both aqueous cells and flare ) at day 14 .


Of randomized patients , 817 received nepafenac 0.3 % , 819 received nepafenac 0.1 % , and 200 and 206 received the respective vehicles .


Significantly more nepafenac 0.3 % patients had no inflammation ( 68.4 % versus 34.0 % ) and were pain free ( 91.0 % versus 49.7 % ) at day 14 than vehicle patients ( both P < .0001 ) .


Nepafenac 0.3 % was noninferior to nepafenac 0.1 % for inflammation ( 95 % confidence interval [ CI ] , -5.73 % to 3.17 % ) and pain-free rates ( 95 % CI , -3.08 % to 2.70 % ) .


At all postoperative visits , fewer treatment failures ( P. 0012 ) and more clinical successes ( P .0264 ) were observed with nepafenac 0.3 % versus vehicle .


Nepafenac 0.3 % was well tolerated and had a safety profile comparable to that of nepafenac 0.1 % .


Once-daily nepafenac 0.3 % was noninferior to nepafenac 0.1 % 3 times daily for prevention and treatment of ocular inflammation and pain following cataract surgery .


The safety of nepafenac 0.3 % was comparable to that of nepafenac 0.1 % , with the added convenience of once-daily dosing .


Drs. Modi , Lehmann , Walters , Fong , Christie , Roel , Nethery , and Reiser have been paid consultants to Alcon Research , Ltd. .


Ms. Sager is an employee of Alcon Research , Ltd. .


Drs. Tsorbatzoglou , Philipson , and Traverso have no financial or proprietary interest in any material or method mentioned .


Many inpatients receive little or no rehabilitation on weekends .


Our aim was to determine what effect providing additional Saturday rehabilitation during inpatient rehabilitation had on functional independence , quality of life and length of stay compared to 5 days per week of rehabilitation .


This was a multicenter , single-blind ( assessors ) randomized controlled trial with concealed allocation and 12-month follow-up conducted in two publically funded metropolitan inpatient rehabilitation facilities in Melbourne , Australia .


Patients were eligible if they were adults ( aged 18 years ) admitted for rehabilitation for any orthopedic , neurological or other disabling conditions excluding those admitted for slow stream rehabilitation/geriatric evaluation and management .


Participants were randomly allocated to usual care Monday to Friday rehabilitation ( control ) or to Monday to Saturday rehabilitation ( intervention ) .


The additional Saturday rehabilitation comprised physiotherapy and occupational therapy .


The primary outcomes were functional independence ( functional independence measure ( FIM ) ; measured on an 18 to 126 point scale ) , health-related quality of life ( EQ-5D utility index ; measured on a 0 to 1 scale , and EQ-5D visual analog scale ; measured on a 0 to 100 scale ) , and patient length of stay .


Outcome measures were assessed on admission , discharge ( primary endpoint ) , and at 6 and 12 months post discharge .


We randomly assigned 996 adults ( mean ( SD ) age 74 ( 13 ) years ) to Monday to Saturday rehabilitation ( n = 496 ) or usual care Monday to Friday rehabilitation ( n = 500 ) .


Relative to admission scores , intervention group participants had higher functional independence ( mean difference ( MD ) 2.3 , 95 % confidence interval ( CI ) 0.5 to 4.1 , P = 0.01 ) and health-related quality of life ( MD 0.04 , 95 % CI 0.01 to 0.07 , P = 0.009 ) on discharge and may have had a shorter length of stay by 2 days ( 95 % CI 0 to 4 , P = 0.1 ) when compared to control group participants .


Intervention group participants were 17 % more likely to have achieved a clinically significant change in functional independence of 22 FIM points or more ( risk ratio ( RR ) 1.17 , 95 % CI 1.03 to 1.34 ) and 18 % more likely to have achieved a clinically significant change in health-related quality of life ( RR 1.18 , 95 % CI 1.04 to 1.34 ) on discharge compared to the control group .


There was some maintenance of effect for functional independence and health-related quality of life at 6-month follow-up but not at 12-month follow-up .


There was no difference in the number of adverse events between the groups ( incidence rate ratio = 0.81 , 95 % CI 0.61 to 1.08 ) .


Providing an additional day of rehabilitation improved functional independence and health-related quality of life at discharge and may have reduced length of stay for patients receiving inpatient rehabilitation .


Australian and New Zealand Clinical Trials Registry ACTRN12609000973213 Please see related commentary : http://www.biomedcentral.com/10.1186/1741-7015-11-199 .


The Resourceful Adolescent Program ( RAP ) is a universal , school-based intervention that has been found to produce small to medium effects in the reduction of adolescent depressive symptoms .


In the present study , we evaluated the effectiveness of a friendship-building skills program -- the Peer Interpersonal Relatedness ( PIR ) program -- in producing larger effects when used in conjunction with RAP .


A cluster-randomized controlled trial was used to assign whole classrooms of adolescent participants recruited from Sydney secondary schools to 1 of 3 conditions : ( a ) RAP-PIR , ( b ) RAP-placebo , or ( c ) assessment-only waiting-list control .


Hierarchical linear modeling ( HLM ) was used to analyze the data .


Across the intervention period , RAP did not significantly reduce depressive symptoms relative to those students not receiving this intervention .


RAP followed by PIR did significantly reduce depressive symptoms relative to those students not receiving PIR .


Across the 12-month follow-up , the between-group reductions in depressive symptoms were no longer significant .


At follow-up , participants in the RAP-PIR condition had achieved significant increases in their school-related life satisfaction and significant increases in social functioning with peers relative to their peers in the other conditions .


The study provides preliminary support for the effectiveness of the PIR program in reducing depressive symptoms when used alongside RAP in the short term and in improving social adjustment and school-related life satisfaction in the longer term .


Given the importance of social adjustment in adolescent mental well-being , the PIR program represents a potentially important addition to the prevention of depression in youth .


It has been proposed that in the same way that conflict between vestibular and visual inputs leads to motion sickness , conflict between motor commands and sensory information associated with these commands may contribute to some chronic pain states .


Attempts to test this hypothesis by artificially inducing a state of sensorimotor incongruence and assessing self-reported pain have yielded equivocal results .


To help clarify the effect sensorimotor incongruence has on pain we investigated the effect of moving in an environment of induced incongruence on pressure pain thresholds ( PPT ) and the pain experienced immediately on completion of PPT testing .


Thirty-five healthy subjects performed synchronous and asynchronous upper-limb movements with and without mirror visual feedback in random order .


We measured PPT over the elbow and the pain evoked by testing .


Generalised linear mixed-models were performed for each outcome .


Condition ( four levels ) and baseline values for each outcome were within-subject factors .


There was no effect of condition on PPT ( p = 0.887 ) or pressure-evoked pain ( p = 0.771 ) .


A sensitivity analysis using only the first PPT measure after each condition confirmed the result ( p = 0.867 ) .


Inducing a state of movement related sensorimotor incongruence in the upper-limb of healthy volunteers does not influence PPT , nor the pain evoked by testing .


We found no evidence that sensorimotor incongruence upregulates the nociceptive system in healthy volunteers .


The aim of this study was to evaluate the safety and efficacy of retropubic ( RP ) or transobturator ( TO ) midurethral slings ( MUS ) in a prospective randomized cohort of Turkish women .


A total of 54 women with urodynamic stress urinary incontinence ( SUI ) were randomized to undergo either RP or TO MUS between August 2006 and February 2013 in a tertiary referral center by a single surgeon .


All patients had history , physical examination , urodynamic evaluation and quality of life assessments .


The validated Turkish versions of the SEAPI , ICIQ-SF and OAB-V8 questionnaires were used .


The Advantage RP and the Obtryx TO MUS Systems were used for all RP and TO procedures .


Twenty-seven patients were randomized to each group .


The median follow-up was 48.5 21.8 months .


The median hospital stay was 24.0 4.8 h and median operative time was 35.0 19.9 min .


The overall objective and subjective cure rates were 92.6 and 79.6 % , respectively .


The quality of life of all patients significantly increased after the operation compared to their preoperative status .


Patients with a poorer subjective cure rate were those with mixed urinary incontinence , whose preoperative SEAPI and OAB-V8 scores were significantly higher .


MUS surgery is highly effective and could safely be performed in a cohort of Turkish women with SUI in subspecialty centers by experienced surgeons .


There is no significant difference between RP or TO applications in terms of safety and efficacy .


Further studies with long-term follow-up data are required .


Pharmacokinetics and bioequivalence of 300 mg irbesartan tablets were studied in 26 healthy Thai male volunteers .


A single oral dose of one 300 mg tablet of the test product and the reference product was given to each volunteer according to a randomized two-way crossover design with 1-week wash out period .


Blood samples were collected at predetermined time intervals until 72 hours post dose and irbesartan concentration was quantified with a validated HPLC method .


Individual plasma irbesartan concentration-time profile was analyzed for pharmacokinetic parameters .


Maximum plasma concentrations ( Cmax ) of 3,617.19 and 3,295.77 ng/mL for test and reference , respectively , were achieved .


Areas under the plasma concentration-time curve ; AUC0-t and AUC0 - were 15,304.65 and 15,638.90 ngh/mL for test and 15,389.21 and 15,730.34 ngh/mL for reference .


The median tmax was 1.50 hours and 1.25 hours for test and reference , respectively .


Plasma elimination half-lives ( t1/2 ) were 7.35 hours and 8.09 hours for test and reference , respectively .


Primary pharmacokinetic parameters Cmax , AUC0-t , and AUC0 - were tested parametrically by analysis of variance ( ANOVA ) , and it revealed no statistically significant difference ( defined as p < 0.05 ) between the corresponding Cmax , AUC0-t , and AUC0 - with respect to sequence , volunteers , period and formulation .


The 90 % confidence intervals for the ratio of test and reference product of the parameters Cmax , AUC0-t , and AUC0 - were within 80 - 125 % ( 100.13 - 121.40 % for Cmax , 90.83 - 106.86 % for AUC0-t and 91.11 - 106.55 % for AUC0 - ) .


The two products were bioequivalent in terms of both rate and extent of drug absorption into systemic circulation .


To evaluate the efficacy of maintenance therapy with oral micronized progesterone ( OMP ) for prolongation of pregnancy in cases of arrested preterm labor .


Ninety women at 24-34weeks of singleton pregnancy with intact membranes and arrested preterm labor were randomly allocated to receive OMP ( n = 45 ) or placebo ( n = 45 ) daily until 37weeks or delivery , whichever was earlier .


Outcome parameters were compared using Student t test , ( 2 ) test , Fisher exact test , and log-rank ( 2 ) test .


OMP significantly prolonged the latency period ( 33.2922.16 vs 23.0715.42 days ; P = 0.013 ) .


Log-rank analysis revealed a significant difference in mean time to delivery between the 2 groups ( P = 0.014 ) .


There were significantly fewer preterm births ( 33 % vs 58 % ; P = 0.034 ) and low birth weight neonates ( 37 % vs 64 % ; P = 0.017 ) , and significantly higher mean birth weight ( 2.440.58 vs 2.140.47 kg ; P = 0.009 ) in the OMP group .


Perinatal outcomes and adverse effects were similar in the 2 groups .


Maintenance tocolysis with OMP significantly prolonged pregnancy and decreased the number of preterm births .


Clinical Trial Registry of India : CTRI/2011/10 / 002043 .


Propofol is commonly used in pediatric sedation , which may cause hypotension during induction .


Our goal was to determine the effect of a preinduction 20-mL/kg isotonic fluid bolus on propofol-induced hypotension , assess clinical signs of hypoperfusion during hypotension , and evaluate for age-related propofol dosing differences .


This prospective , randomized , controlled , nonblinded study was conducted at Children 's Hospital of Illinois .


Patients were children 6 to 60 months of age who needed sedation for MRI or auditory brainstem-evoked response testing .


The treatment group received a preinduction 20-mL/kg isotonic saline bolus before procedure initiation .


Patients were continuously monitored via cardiorespiratory monitor with pulse oximetry and end-tidal carbon dioxide measurements .


Cardiovascular indices and clinical signs of hypoperfusion were compared between groups , and propofol dosing differences were compared between age groups .


One hundred twenty-six patients were randomly assigned to treatment ( n = 52 ) or control ( n = 74 ) conditions .


Twelve patients in the treatment group and 14 patients in the control group experienced postinduction hypotension , as defined by the Pediatric Advanced Life Support guidelines .


One patient in each group was given volume resuscitation when blood pressure did not improve after a reduction in the propofol infusion rate .


No hypotensive patients had physical signs of hypoperfusion , and patients1 year of age needed significantly more propofol .


A 20-mL/kg preinduction isotonic saline bolus does not prevent propofol-induced hypotension .


No clinical signs of hypoperfusion were noted with induced hypotension , and infants12 months old need significantly more propofol per kilogram for procedures .


We examined contraceptive use and dual protection in the postpartum period in a Prevention of Mother to Child Transmission population and whether it varied by HIV status .


Data are from a prospective study , the South Africa HIV Antenatal Post-test Support Study .


Pregnant participants were recruited from a government clinic in an urban township , and the analytic sample was 821 .


Following enrollment , participants were tested for HIV and administered a questionnaire at baseline and 14 weeks postpartum .


We used generalized linear regression models to examine HIV status and use of modern contraceptives at 14 weeks .


The risk ratio of condom use at 14 weeks postpartum was 1.66 [ 95 % confidence interval ( CI ) : 1.36-2 .02 ] for HIV-positive compared to HIV-negative women .


The risk ratio for dual protection ( use of a condom and a hormonal method ) was 1.96 ( 95 % CI : 1.39-2 .79 ) at 14 weeks for HIV-positive compared to HIV-negative women .


HIV positive status may be a motivating factor for women to use condoms and dual protection .


In this setting where HIV is highly prevalent , it is ever more important that women control the timing and limiting of births so as to preserve the health of the mother and child .


HIV status may be an important motivating behavioral factor for women to use contraceptives and dual protection in the postpartum period .


The INSPIRON-I trial is a first-in-man evaluation of the safety and efficacy of the Inspiron drug-eluting stent , a sirolimus-eluting stent with abluminal biodegradable polymer coating and thin cobalt-chromium alloy .


This is a randomised , multicentre comparison between Inspiron and a stent with the same metallic structure but without polymer coating or drug elution ( Cronus ) .


The primary objective was to evaluate the in-segment late loss ( LLL ) at six months .


Secondary endpoints included percent in-stent obstruction as measured by intravascular ultrasound ( IVUS ) at six months and major adverse cardiac events ( MACE ) .


Fifty-eight patients were enrolled ( 60 lesions ) , 39 for Inspiron and 19 for Cronus .


Baseline clinical and angiographic characteristics of both groups were similar .


At six months , the in-segment LLL was reduced in the Inspiron group compared to the control group ( 0.190.16 mm vs. 0.580.4 mm , respectively ; p < 0.001 ) , as well as the percent neointimal obstruction ( 7.87.1 % vs. 26.511.4 % ; p < 0.001 ) .


At two-year follow-up , incidence of MACE was similar between groups ( 7.9 vs. 21.1 % , respectively ; p = 0.20 ) , with lower target lesion revascularisation for Inspiron ( 0 vs. 21.1 % , respectively ; p = 0.01 ) and no stent thrombosis .


Sirolimus eluted from an abluminal biodegradable polymer on a cobalt-chromium alloy proved effective in reducing restenosis at six months .


Chronic liver disease leads to fibrosis and cirrhosis of the liver .


This may , in turn , result in chronic liver failure or the development of hepatocellular carcinoma ( HCC ) .


Main risk factors for chronic liver disease are viral hepatitis and alcoholism .


The present study assessed a randomly selected population in southern Germany for risk factors for chronic liver disease such as fatty liver disease , viral hepatis infection and life-style factors .


In addition , the potential association with elevated liver enzymes was investigated .


A total of 2256 subjects ( 1182 females , 1074 males ) , aged 18 - 65 years , participated in the study .


Each subject underwent a standardized ultrasound examination , and anthropometric and biochemical assessments .


Test subjects were randomly selected from the general population of a town in southwestern Germany .


Data were acquired from November to December 2002 without further follow-up .


Several factors were found to be associated with chronic liver disease in the study population .


Alcohol consumption > 20 g/d was seen in 18.1 % ( n = 409 ) .


Metabolic syndrome was diagnosed in 5.9 % ( n = 132 ) .


The number of people with a BMI greater than 25 kg/m ( 2 ) was 45.1 % ( n = 1017 ) .


The prevalence of subjects with chronic hepatitis B was 0.7 % ( n = 15 ) , that of anti-HCV positive patients , 0.6 % ( n = 15 ) .


Elevated gGT was seen in 10.4 % ( n = 14 ) of the patients .


Prevalence of hepatic steatosis was 25.0 % ( n = 564 ) .


Many cases of chronic liver disease could be prevented by healthy nutrition , optimized medical treatment of associated disorders , and prevention strategies such as routine vaccination , in particular , against hepatitis B virus ( HBV ) .


Helicobacter pylori infection is an emerging health concern to some northern Canadian Aboriginal communities and their clinicians .


Clinicians in the north perceive H. pylori infection to be a major clinical problem because they find H. pylori infection in many patients evaluated for common stomach complaints , leading to frequent demand for treatment , which often fails .


Moreover , public health authorities identified the need for information to develop locally appropriate H. pylori control strategies .


We described adherence and identified barriers to completing treatment among H. pylori-positive participants in a community-based project inspired by local concerns about H. pylori infection risks .


In 2008 , 110 H. pylori-positive participants ( diagnosed by a breath test , histopathology and/or culture ) of the Aklavik H. pylori project were randomised to standard-of-care or sequential treatment .


We ascertained adherence by interviewing participants using a structured questionnaire .


We estimated adherence frequencies as the proportion of participants who reported taking either 100 % of doses ( perfect adherence ) or 80 % of doses ( good adherence ) .


To compare the proportion with perfect or good adherence in subgroups , we report proportion differences and 95 % confidence intervals ( CI ) .


Of 87 participants who were interviewed , 64 % reported perfect adherence and 80 % reported good adherence .


We observed more frequent perfect adherence for : standard therapy ( 67 % ) versus sequential ( 62 % ) ; males ( 76 % ) versus females ( 52 % ) ; participants 40-77 years ( 79 % ) versus 17-39 ( 50 % ) .


Proportion differences were 5 % ( CI : -15 , 25 ) for standard versus sequential therapy ; 23 % ( CI : 4 , 43 ) for male versus female ; and 29 % ( CI : 10 , 48 ) for 40-77 versus 15-39 years for perfect adherence .


Of the 29 participants who reported poor adherence ( < 80 % of doses taken ) , the following barriers to treatment were reported : changed mind about taking treatment ( 24 % ) , consumption of alcoholic beverages ( 18 % ) , nausea ( 18 % ) , forgetfulness ( 12 % ) , stomach pain ( 12 % ) , difficulty in swallowing pills ( 6 % ) , no reason ( 6 % ) or bad taste of the pills ( 6 % ) .


This analysis suggests that adherence to treatment for eliminating H. pyori infection may vary by regimen and may be influenced by socio-demographic factors .


These findings add to the small body of evidence pertaining to adherence to H. pylori treatment in Arctic Aboriginal communities .


On-going research in additional northern Canadian communities will accumulate data for developing recommendations to improve adherence for treatment to eliminate H. pylori infection .


Clinical indications for hydroxyethyl starches ( HES ) in horses include rapid plasma volume expansion and oncotic support during periods of hypoproteinaemia .


Side effects such as coagulopathies associated with HES administration pose limitations to their use in veterinary medicine .


In man , tetrastarch ( 130/0 .4 ) has demonstrated less profound effects on coagulation compared with first - and second-generation HES .


To evaluate the haemostatic and oncotic effects of tetrastarch ( 130/0 .4 ) administered at 10 , 20 and 40ml/kg bwt in healthy horses .


Randomised crossover experiment .


Tetrastarch ( 130/0 .4 ) was administered to 6 healthy pony mares at 10 , 20 and 40ml/kg bwt with a 2-week washout period .


Packed cell volume , plasma total solids , colloid osmotic pressure ( COP ) , platelet count and thromboelastography ( TEG ) were measured at baseline , immediately after infusion ( 0h ) , and 1 , 6 , 12 , 24 , 48 and 96h after tetrastarch infusion .


All TEG variables remained within normal reference ranges in all 3 treatment groups .


Administration of tetrastarch at 40ml/kg bwt resulted in a prolonged K-time ( P = 0.049 ) at 6h post infusion , and decreased maximum amplitude at 0 ( P < 0.001 ) , 1 ( P = 0.022 ) , 6 ( P = 0.006 ) , 24 ( P < 0.001 ) and 48h ( P = 0.013 ) post infusion compared with baseline .


Administration of tetrastarch increased mean COP values above baseline in all 3 treatment groups , persisting to 24 , 6 and 48h for the 10 , 20 and 40ml/kg bwt doses , respectively .


Although still within established reference ranges , compared with lower dosages , the administration of 40ml/kg bwt tetrastarch ( 130/0 .4 ) is more likely to induce changes in coagulation as measured by TEG .


Tetrastarch increased COP at all dosages evaluated in healthy horses .


Tetrastarch ( 130/0 .4 ) at 10 and 20ml/kg bwt has potential as a synthetic colloid for resuscitation and provision of oncotic support in horses .


To evaluate the 30-month clinical performance of a nanofilled-resin composite with or without glass-fiber layering in restorations of large cavities in posterior teeth of children .


A total of 71 restorations were placed in permanent molar teeth of 47 children ( mean age 10.9 years ) with ( FRC ; n = 35 ) or without ( RC ; n = 36 ) fiber layering .


One operator placed all restorations .


Restorations were evaluated according to the USPHS modified-Ryge criteria at baseline , 6 , 12 , 18 , 24 , and 30 months .


The data were analyzed using Fisher 's exact and chi-square tests and outcomes were compared using the Cochran-Q test ( p < 0.05 ) .


The 30-month survival rates of the restorations were 97 % and 97.1 % in the RC and FRC groups , respectively .


Nanofilled-resin restorations with or without glass fiber-layering showed similarly high clinical performance .


No differences were detected between the evaluated criteria when comparing baseline with any of the evaluation periods ( p < 0.05 ) .


After 30 months there were no secondary caries , change in anatomical form or postoperative sensitivity .


Only minor changes for marginal adaptation , marginal discoloration , color match and surface texture were observed .


It was concluded that nanofilled-resin composite applied with or without glass-fiber layering showed similar and good results in large cavities of posterior permanent teeth in children over a 30-month period .


Sitting time ( ST ) , a form of sedentary behavior , has been identified as a highly prevalent risk factor for multiple sclerosis ( MS ) - related morbidity .


There is limited information on the efficacy of behavioral interventions for reducing ST in persons with MS.


To examine the efficacy of a behavioral intervention for reducing ST in persons with MS in a pilot RCT .


Seventy MS patients were randomly assigned to intervention and waitlist control conditions .


The behavioral intervention was delivered April-September 2012 via the Internet and consisted of a dedicated website and one-on-one Skype video chats that taught participants the skills , techniques , and strategies for reducing sedentary behavior based on social cognitive theory .


ST was measured by questions on the abbreviated International Physical Activity Questionnaire ( IPAQ ) before and after the 6-month RCT .


Data were analyzed in SPSS , version 21.0 in March 2014 .


ANCOVA was performed on post-intervention scores controlling for pre-intervention values using an intent-to-treat analysis .


The group main effect was statistically significant ( F [ 1 , 67 ] = 4.03 , p < 0.05 , = 0.06 ) and yielded a parameter estimate of 98.9 ( SE = 49.3 , t = 2.01 , p < 0.05 ) .


The adjusted mean scores for intervention and control groups were 429.2 ( 201.2 ) and 528.2 ( 200.7 ) minutes of ST , respectively ( d = 0.49 ) .


We provide the first data on the efficacy of a behavioral intervention for reducing ST in MS patients .


This highlights the importance of designing and testing the effect of behavioral interventions that reduce ST on secondary outcomes such as function , symptoms , quality of life , and health status in persons with MS.


The parallel-group randomized active-controlled clinical study was conducted to compare the effectiveness of two in-hospital range of motion ( ROM ) exercise programs following total knee arthroplasty ( TKA ) .


Continuous passive motion ( CPM ) is frequently used to increase ROM and improve postoperative recovery despite little conclusive scientific evidence .


In contrast , a new active sling-based ROM therapy requires the activation of the knee joint muscles and dynamic joint stabilization .


It was hypothesized that higher demands on muscle strength and muscle coordination during sling exercise training ( ST ) might be advantageous for early recovery following TKA .


A total of 125 patients undergoing primary TKA were assessed for eligibility .


Thirty-eight patients were randomly assigned to receive ST or CPM ( control intervention ) during hospital stay .


Patients were assessed before TKA for baseline measurement ( pretest ) , 1day before discharge ( posttest ) and 3months after TKA ( follow-up ) .


The passive knee flexion range of motion ( pFL ) was the primary outcome measure .


Secondary outcome measures included active knee flexion range of motion , active and passive knee extension ROM , static postural control , physical activity , pain , length of hospital stay as well as clinical , functional and quality-of-life outcomes ( SF-36 , HSS and WOMAC scores ) .


Data were analyzed according to the intention-to-treat principle .


Differences between the groups were tested for significance by the unpaired Student 's t test or an analysis of covariance ( ANCOVA ) adjusted for baseline , weight , sex , age , pain and physical activity .


A between-group difference could be determined at posttest .


The pFL was significantly higher by 6.0 ( 95 % CI 0.9 to 11.2 ; P = 0.022 ) in the ST group .


No difference between groups in pFL was documented at follow-up .


Furthermore , no significant differences could be observed for any secondary outcome measure at posttest and follow-up .


ST seems to have a clinically relevant beneficial short-term effect on pFL compared to CPM .


The results support the implementation of ST in rehabilitation programs following TKA .


Therapy , level 2b .


Small increases in mean serum creatinine ( SCr ) were observed in studies of rheumatoid arthritis patients during tofacitinib treatment .


These SCr changes were investigated and potential mechanisms explored .


SCr values and renal adverse event data were pooled from five Phase 3 and two long-term extension ( LTE ) studies .


Dose-response relationships and association with inflammation ( C-reactive protein ( CRP ) ) were explored using Phase 2 data and confirmed with Phase 3 data .


In Phase 3 , least squares mean SCr differences from placebo at Month 3 were 0.02 and 0.04 mg/dl for tofacitinib 5 and 10 mg twice daily ( BID ) ( P < 0.05 ) , respectively .


During Months 0 to 3 , confirmed SCr 33 % increases over baseline were reported in 17 ( 1.4 % ; 5 mg BID ) and 23 ( 1.9 % ; 10 mg BID ) patients .


Generally , elevations plateaued and remained within normal limits throughout Phase 3 and LTE studies .


Exposure-response modeling demonstrated small , reversible effects of tofacitinib on mean SCr , and significant ( P < 0.05 ) effects of CRP on model parameters .


Phase 3 data confirmed that patients with higher baseline CRP or greater CRP decreases following tofacitinib treatment had the largest increases in SCr .


Across Phase 3 and LTE studies , 22 tofacitinib-treated patients had clinical acute renal failure ( ARF ) , predominantly in the setting of concurrent serious illness .


Tofacitinib treatment was associated with small , reversible mean increases in SCr that plateaued early .


The mechanism behind these SCr changes remains unknown , but may involve effects of tofacitinib on inflammation .


ARF occurred infrequently , was associated with concurrent serious illness , and was unrelated to prior SCr increases .


To assess safety up to 1year of follow-up associated with prasugrel and clopidogrel use in a prospective cohort of patients with acute coronary syndromes ( ACS ) .


Between 2009 and 2012 , 2286 patients invasively managed for ACS were enrolled in the multicentre Swiss ACS Bleeding Cohort , among whom 2148 patients received either prasugrel or clopidogrel according to current guidelines .


Patients with ST-elevation myocardial infarction ( STEMI ) preferentially received prasugrel , while those with non-STEMI , a history of stroke or transient ischaemic attack , age 75years , or weight < 60kg received clopidogrel or reduced dose of prasugrel to comply with the prasugrel label .


After adjustment using propensity scores , the primary end point of clinically relevant bleeding events ( defined as the composite of Bleeding Academic Research Consortium , BARC , type 3 , 4 or 5 bleeding ) at 1year , occurred at a similar rate in both patient groups ( prasugrel/clopidogrel : 3.8 % / 5.5 % ) .


Stratified analyses in subgroups including patients with STEMI yielded a similar safety profile .


After adjusting for baseline variables , no relevant differences in major adverse cardiovascular and cerebrovascular events were observed at 1year ( prasugrel/clopidogrel : cardiac death 2.6 % / 4.2 % , myocardial infarction 2.7 % / 3.8 % , revascularisation 5.9 % / 6.7 % , stroke 1.0 % / 1.6 % ) .


Of note , this study was not designed to compare efficacy between prasugrel and clopidogrel .


In this large prospective ACS cohort , patients treated with prasugrel according to current guidelines ( ie , in patients without cerebrovascular disease , old age or underweight ) had a similar safety profile compared with patients treated with clopidogrel .


SPUM-ACS : NCT01000701 ; COMFORTABLE AMI : NCT00962416 .


Smoking rates , and associated negative health outcomes , are disproportionately high among people with mental illness compared to the general population .


Smoke-free policies within mental health hospitals can positively impact on patients ' motivation and self-efficacy to address their smoking .


However , without post-discharge support , preadmission smoking behaviours typically resume .


This protocol describes a randomised controlled trial that aims to assess the efficacy of linking mental health inpatients to community-based smoking cessation supports upon discharge as a means of reducing smoking prevalence .


Eight hundred participants with acute mental illness will be recruited into the randomised controlled trial whilst inpatients at one of four psychiatric inpatient facilities in the state of New South Wales , Australia .


After completing a baseline interview , participants will be randomly allocated to receive either : ` Supported Care ' , a multimodal smoking cessation intervention ; or ` Normal Care ' , consisting of existing hospital care only .


The ` Supported Care ' intervention will consist of a brief motivational interview and a package of self-help material for abstaining from smoking whilst in hospital , and , following discharge , 16 weeks of motivational telephone-based counselling , 12 weeks of free nicotine replacement therapy , and a referral to the Quitline .


Data will be collected at 1 , 6 and 12 months post-discharge via computer-assisted telephone interview .


The primary outcomes are abstinence from smoking ( 7-day point prevalence and prolonged cessation ) , and secondary outcomes comprise daily cigarette consumption , nicotine dependence , quit attempts , and readiness to change smoking behaviour .


If shown to be effective , the study will provide evidence in support of systemic changes in the provision of smoking cessation care to patients following discharge from psychiatric inpatient facilities .


Australian New Zealand Clinical Trials Registry ANZTCN : ACTRN12612001042831 .


Date registered : 28 September 2012 .


The aim was to evaluate the feasibility and safety of early chest tube removal after complete video-assisted thoracic lobectomy ( CVATL ) .


Retrospective analysis was performed on effects of chest tube removal on patients with lung cancer after pulmonary lobectomy between November 2013 and October 2014.154 eligible patients included 97 cases for CVATL and 57 cases for open thoracic lobectomy .


Patients with CVATL were divided randomly into experimental group ( EG ) and control group ( CG ) , in which 51 patients in EG had chest tube removal on the 2 nd day after operation ; 46 patients in CG had the tube removal when the drainage volume < 100 ml/day .


Patients in open thoracic lobectomy group ( OG ) had the tubes removal as CG .


The drainage volumes of the 1 st and 2 nd 24 h after operation , duration of chest tubes , cases of pain alleviation , and recurrent pleural effusions requiring reintervention were measured .


The average drainage volume of the 1 st 24 h after operation of CVATL group from EG and CG was significantly reduced than that in OG ( 260.41 ml vs. 353.16 ml , P < 0.001 ) .


The average drainage volume of the 2 nd 24 h after operation of CG was significantly reduced than that in OG ( 163.91 ml vs. 222.98 ml , P < 0.001 ) .


The average duration of chest tube of CG for 2.98 days showed significant different compared with OG for 3.81 days ( P < 0.001 ) .


Chest tube removal in CVATL group increased more chest pain alleviation than OG ( 80.4 % vs. 56.1 % , P = 0.001 ) .


The frequencies of recurrent pleural effusions requiring reintervention were 5.88 % ( 3/51 ) , 4.35 % ( 2/46 ) and 5.26 % ( 3/57 ) , respectively , which had no significant differences between three groups ( P = 1.000 ) .


Complete video-assisted thoracic lobectomy brings less drainage volume after operation .


Early removal of chest tube in CVATL shows feasible and safe and demonstrates that it may reduce postoperative pain and help fast recovery .


To determine the clinical effectiveness of an exercise programme on self-reported hand activity performance in people with hand osteoarthritis ( OA ) .


In this randomized , controlled trial , participants with physician-confirmed hand OA were randomly allocated to a 12-week exercise intervention ( group - and home-based ) or usual care .


The primary outcome was self-reported hand activity performance at 3 months measured by the Functional Index for Hand Osteoarthritis ( FIHOA ) and a patient-generated measure of disability , the Patient-Specific Functional Scale ( PSFS ) .


Of 130 randomized participants ( mean age 66 ( standard deviation ( SD ) 9 ) ; female 90 % ) , 120 ( 92 % ) and 119 ( 92 % ) completed the 3 - and 6-month follow-ups .


The adjusted mean difference for the exercise vs control group was -0.5 points ( 95 % confidence interval ( CI ) -1.6 , 0.6 ) for the FIHOA score ( 0-30 scale , 0 = best ) and 0.9 points ( 95 % CI 0.1 , 1.7 ) for the PSFS score ( 0-10 scale , 10 = best ) .


Small significant mean differences in favour of the intervention group were found for hand pain , hand stiffness and disease activity , whereas no mean differences were observed in hand dexterity or maximal grip strength .


A significantly larger proportion in the intervention ( 46 % ) vs control group ( 16 % ) fulfilled the Outcome Measures in Rheumatological Clinical Trials-Osteoarthritis Research Society International ( OMERACT-OARSI ) responder criteria at 3 months ( OR = 4.4 , 95 % CI 1.9 , 10.2 ) .


At the 6-month follow-up , there were no significant group differences in any outcome .


The exercise programme was well tolerated among people with hand OA , but resulted only in small , beneficial short-term improvements on self-reported measures and not on most performance-based tests .


Future studies should address optimal grip strength exercises and dosage .


ClinicalTrials.gov registration number : NCT01245842 .


Systemic inflammation , endothelial dysfunction , and oxidative stress are involved in the pathogenesis of the metabolic syndrome ( MetS ) .


Epidemiological evidence supports an association between whole soy food consumption and reduced risk of cardiovascular disease ( CVD ) .


The objective of this randomized , controlled , cross-over study was to evaluate the effects of soy nut consumption on inflammatory biomarkers and endothelial function and to assess whether isoflavone metabolism to secondary products , equol , and/or O-desmethylangolensin ( ODMA ) , modifies these responses .


n = 17 adults at cardiometabolic risk were randomly assigned to the order of two snack interventions , soy nuts , and macronutrient-matched control snack , for four weeks each , separated by a two week washout period .


Outcome measures included biomarkers of inflammation , oxidative stress , and glycemic control ( ELISA and clinical analyzers ) , endothelial function , and arterial stiffness ( peripheral arterial tonometry ( PAT ) ) , and isoflavone metabolites ( LC-MS/MS ) .


Results revealed that consuming soy nuts improved arterial stiffness as assessed by the augmentation index using PAT ( p = 0.03 ) , despite lack of improvement in inflammatory biomarkers .


Addition of equol and/or ODMA production status as covariates did not significantly change these results .


Soy nuts when added to a usual diet for one month provide some benefit on arterial stiffness in adults at cardiometabolic risk .


The addition of PCV ( procarbazine , lomustine , and vincristine ) chemotherapy to radiotherapy ( RT ) for patients with WHO grade 2 glioma improves progression-free survival ( PFS ) .


The effect of therapy intensification on cognitive function ( CF ) remains a concern in this population with substantial long-term survival .


A total of 251 patients with WHO grade 2 glioma age 40 years with any extent of resection or age < 40 years with subtotal resection/biopsy were randomly assigned to RT ( 54 Gy ) or RT plus PCV .


We observed 111 patients age < 40 years with gross total resection .


CF was assessed by Mini-Mental State Examination ( MMSE ) at baseline and years 1 , 2 , 3 , and 5 .


Overall , few patients experienced significant decline in MMSE score .


There were no significant differences in the proportion of patients experiencing MMSE score decline between the randomized study arms at any time point .


Both study arms experienced a significant gain in average MMSE score longitudinally over time , with no difference between arms .


The MMSE is a relatively insensitive tool , and subtle changes in CF may have been missed .


However , the addition of PCV to RT did not result in significantly higher rates of MMSE score decline than RT alone through 5 years of follow-up .


Patients in both randomly assigned arms experienced a statistically significant average MMSE score increase over time , with no difference between arms .


The addition of PCV chemotherapy to RT improves PFS without excessive CF detriment over RT alone for patients with low-grade glioma .


With use of EGFR tyrosine-kinase inhibitor monotherapy for patients with activating EGFR mutation-positive non-small-cell lung cancer ( NSCLC ) , median progression-free survival has been extended to about 12 months .


Nevertheless , new strategies are needed to further extend progression-free survival and overall survival with acceptable toxicity and tolerability for this population .


We aimed to compare the efficacy and safety of the combination of erlotinib and bevacizumab compared with erlotinib alone in patients with non-squamous NSCLC with activating EGFR mutation-positive disease .


In this open-label , randomised , multicentre , phase 2 study , patients from 30 centres across Japan with stage IIIB/IV or recurrent non-squamous NSCLC with activating EGFR mutations , Eastern Cooperative Oncology Group performance status 0 or 1 , and no previous chemotherapy for advanced disease received erlotinib 150 mg/day plus bevacizumab 15 mg/kg every 3 weeks or erlotinib 150 mg/day monotherapy as a first-line therapy until disease progression or unacceptable toxicity .


The primary endpoint was progression-free survival , as determined by an independent review committee .


Randomisation was done with a dynamic allocation method , and the analysis used a modified intention-to-treat approach , including all patients who received at least one dose of study treatment and had tumour assessment at least once after randomisation .


This study is registered with the Japan Pharmaceutical Information Center , number JapicCTI-111390 .


Between Feb 21 , 2011 , and March 5 , 2012 , 154 patients were enrolled .


77 were randomly assigned to receive erlotinib and bevacizumab and 77 to erlotinib alone , of whom 75 patients in the erlotinib plus bevacizumab group and 77 in the erlotinib alone group were included in the efficacy analyses .


Median progression-free survival was 160 months ( 95 % CI 139-181 ) with erlotinib plus bevacizumab and 97 months ( 57-111 ) with erlotinib alone ( hazard ratio 054 , 95 % CI 036-079 ; log-rank test p = 00015 ) .


The most common grade 3 or worse adverse events were rash ( 19 [ 25 % ] patients in the erlotinib plus bevacizumab group vs 15 [ 19 % ] patients in the erlotinib alone group ) , hypertension ( 45 [ 60 % ] vs eight [ 10 % ] ) , and proteinuria ( six [ 8 % ] vs none ) .


Serious adverse events occurred at a similar frequency in both groups ( 18 [ 24 % ] patients in the erlotinib plus bevacizumab group and 19 [ 25 % ] patients in the erlotinib alone group ) .


Erlotinib plus bevacizumab combination could be a new first-line regimen in EGFR mutation-positive NSCLC .


Further investigation of the regimen is warranted .


Chugai Pharmaceutical Co Ltd. .


Mitral regurgitant volume ( MRvol ) is an important index of the severity of mitral regurgitation ( MR ) , but MRvol measurement remains challenging .


With the development of probe technology and software , General Imaging 3D Quantification ( GI 3DQ ) allows the direct measurement of MR jet volume .


The aim of this study was to evaluate the feasibility and accuracy of MRvol by quantification of MR jet volume using GI 3DQ .


Ninety-three patients were included , 61 with functional MR and 32 with mitral valve prolapse .


Patients with MR were also divided into those with central MR ( n = 41 ) and those with eccentric MR ( n = 52 ) .


MRvol was assessed using GI 3DQ and the proximal isovelocity surface area ( PISA ) method .


MRvol using effective regurgitant orifice area by real-time three-dimensional echocardiography multiplied by the MR time-velocity integral was used as the reference method .


MRvol measured by GI 3DQ and the PISA method had good correlation with MRvol by the reference method .


A significant underestimation of MRvol using GI 3DQ and the PISA method was observed in the assessment of eccentric MR , but without a significant difference in the assessment of central MR.


Quantification of MRvol with GI 3DQ was feasible .


Quantification of central MRvol using this methodology is accurate compared with the reference method .


Quantification of MRvol with GI 3DQ has no significant difference from the currently recommended PISA method .


The occipito-posterior ( OP ) fetal head position during the first stage of labour occurs in 10-34 % of cephalic presentations .


Most will spontaneous rotate in anterior position before delivery , but 5-8 % of all births will persist in OP position for the third stage of labour .


Previous observations have shown that this can lead to an increase of complications , such as an abnormally long labour , maternal and fetal exhaustion , instrumental delivery , severe perineal tears , and emergency caesarean section .


Usual care in the case of diagnosis of OP position is an expectant management .


However , maternal postural techniques have been reported to promote the anterior position of the fetal head for delivery .


A Cochrane review reported that these maternal positions are well accepted by women and reduce back pain .


However , the low sample size of included studies did not allow concluding on their efficacy on delivery outcomes , particularly those related to persistent OP position .


Our objective is to evaluate the efficacy of maternal position in the management of OP position during the first stage of labour .


A randomised clinical trial is ongoing in the maternity unit of the Geneva University Hospitals , Geneva , Switzerland .


The unit is the largest in Switzerland with 4,000 births/year .


The trial will involve 438 women with a fetus in OP position , confirmed by sonography , during the first stage of the labour .


The main outcome measure is the position of the fetal head , diagnosed by ultrasound one hour after randomisation .


It is important to evaluate the efficacy of maternal position to correct fetal OP position during the first stage of the labour .


Although these positions seem to be well accepted by women and appear easy to implement in the delivery room , the sample size of the last randomised clinical trial published in 2005 to evaluate this intervention had insufficient power to demonstrate clear evidence of effectiveness .


If the technique demonstrates efficacy , it would reduce the physical and psychological consequences of complications at birth related to persistent OP position .


ClinicalTrials.gov , http://www.clinicaltrials.gov: ( no .


NCT01291355 ) .


Retroperitoneal soft tissue sarcomas ( RPS ) are rare tumors that include several well-defined histologic subtypes .


Although surgery is the mainstay of curative therapy , no universally accepted recommendations concerning the best management have been developed to date .


Optimization of the initial approach is critical for maximizing patient outcomes .


An RPS Trans-Atlantic Working Group was established in 2013 .


The primary aim was to evaluate the current evidence critically and to develop a consensus document on the approach to this difficult disease .


The outcome applies to primary RPS that is nonvisceral in origin .


The evaluation included sarcomas of major veins ( inferior vena cava , renal vein , ovarian/testicular vein ) , undifferentiated pleomorphic sarcoma of the psoas , and ureteric leiomyosarcoma ( LMS ) .


It excluded desmoid , lipoma and angiomyolipoma , gastrointestinal stromal tumors , visceral sarcomas such as those arising from the gut or its mesentery , uterine LMS , prostatic sarcoma , paratesticular/spermatic cord sarcoma , Ewing 's sarcoma , alveolar/embryonal rhabdomyosarcoma , primitive peripheral neuro-ectodermal tumor , sarcoma arising from teratoma , carcinosarcoma , sarcomatoid carcinoma , clear cell sarcoma , radiation-induced sarcoma , paraganglioma , and malignant pheochromocytoma .


Management of RPS was evaluated from diagnosis to follow-up , and a level of evidence was attributed to each statement .


This rare and complex malignancy is best managed by an experienced multidisciplinary team in a specialized referral center .


The best chance of cure is at the time of primary presentation , and an individualized management plan should be made based on the statements included in this article .


International collaboration is critical for adding to the current knowledge .


A prospective registry will be set up .


To investigate the effects of Swedish massage with aromatic ginger oil ( SMGO ) on chronic low back pain and disability in older adults compared with traditional Thai massage ( TTM ) .


Randomized controlled trial .


Massage clinic in Ratchaburi province , Thailand .


164 patients were screened ; 140 were eligible , and randomized to either SMGO ( n = 70 ) or TTM ( n = 70 ) .


Trained staff provided participants with a 30-min SMGO or TTM twice a week for five weeks .


The Visual Analogue Scale ( VAS ) assessed immediate effect ( after each massage ) and the short form McGill Pain Questionnaire ( MPQ ) assessed effectiveness of massage in short-term ( six weeks ) and long-term ( 15 weeks ) .


Disability improvement was measured by the Owestry Disability Questionnaire ( ODQ ) at baseline , short - and long-term .


Both SMGO and TTM led to significant improvements in pain intensity ( p < 0.05 ) and disability ( p < 0.05 ) across the period of assessments , indicating immediate , short - and long-term effectiveness .


SMGO was more effective than TTM in reducing pain ( p = 0.04 ) and improving disability at short - and long-term assessments ( p = 0.04 ) .


These findings suggest that the integration of either SMGO or TTM therapy as additional options to provide holistic care to older people with chronic low back pain could be considered by health professionals .


Further research into the use of ginger as an adjunct to massage therapy , particularly TTM , is recommended .


To determine whether 1-week stenting of the pelvi-ureteric anastomosis of laparoscopic or robot-assisted pyeloplasty is as effective as 4-week stenting , based on their respective success rates .


A total of 100 patients with pelvi-ureteric junction obstruction were treated by Anderson-Hynes pyeloplasty and the anastomosis was stented using a 6-F JJ catheter for either 1 week ( 1W series ) or 4 weeks ( 4W series ) , based on a randomisation protocol .


Postoperative follow-up was performed at 3 months using intravenous urography ( IVU ) , at 6 months using diuretic renography and at 1 , 3 and 5 years using ultrasonography .


Statistical analysis was performed using a one-sided Z-test , Pearsons 's chi-squared test and a Wilcoxon rank sum test .


The primary outcome measure , success rate , which was defined as no obstruction on IVU and diuretic renography , was 100 % in the 1W series and not inferior to the success rate of 98 % in the 4W series ( P = 0.006 ) .


The following secondary outcome measures were not significantly different between the 1W and the 4W series with regard to residual symptoms ( 10 vs 6 % ; P = 0.48 ) , rate of complications ( 4 vs 6 % ; P = 0.65 ) , need for synchronous robot-assisted pyelolithotomy ( 4 vs 8 % ; P = 0.47 ) , improvement in split renal function ( 1 vs 0 % ; P = 0.59 ) and duration of surgery ( 200 vs 192min ; P = 0.87 ) .


Only length of hospital stay was significantly different ; this was shorter in the 1W series ( 5 vs 6 days ; P = 0.01 ) .


Stenting of the pelvi-ureteric anastomosis after laparoscopic or robot-assisted pyeloplasty for 1 week is as effective as stenting for 4 weeks .


Both procedures , laparoscopic or robot-assisted pyeloplasty have an excellent success rate .


We previously reported results of our on-line microsurgery training program , showing that residents who had access to our website significantly improved their cognitive and technical skills .


In this study , we report an objective means for expert evaluators to reliably rate trainees ' technical skills under the microscope , with the use of our novel global rating scale .


`` Microsurgery Essentials '' ( http://smartmicrosurgery.com ) is our on-line training curriculum .


Residents were randomly divided into 2 groups : 1 group reviewed this online resource and the other did not .


Pre - and post-tests consisted of videotaped microsurgical sessions in which the trainee performed `` microsurgery '' on 3 different models : latex glove , penrose drain , and the dorsal vessel of a chicken foot .


The SMaRT ( Stanford Microsurgery and Resident Training ) scale , consisting of 9 categories graded on a 5-point Likert scale , was used to assess the trainees .


Results were analyzed with ANOVA and Student t test , with P less than 0.05 indicating statistical significance .


Seventeen residents participated in the study .


The SMaRT scale adequately differentiated the performance of more experienced senior residents ( PGY-4 to PGY-6 , total average score = 3.43 ) from less experienced junior residents ( PGY-1 to PGY-3 , total average score = 2.10 , P < 0.0001 ) .


Residents who viewed themselves as being confident received a higher score on the SMaRT scale ( average score 3.5 ) , compared to residents who were not as confident ( average score 2.1 ) ( P < 0.001 ) .


There were no significant differences in scoring among all 3 evaluators ( P > 0.05 ) .


Additionally , junior residents who had access to our website showed a significant increase in their graded technical performance by 0.7 points when compared to residents who did not have access to the website who showed an improvement of only 0.2 points ( P = 0.01 ) .


Our SMaRT scale is valid and reliable in assessing the microsurgical skills of residents and other trainees .


Current trainees are more likely to use self-directed on-line education because of its easy accessibility and interactive format .


Our global rating scale can help ensure residents are achieving appropriate technical milestones .


To determine the efficacy of timolol 0.1 % gel in preventing increased intraocular pressure ( IOP ) after uncomplicated cataract surgery .


In this prospective , double-blinded , randomized study were enrolled 70 patients who underwent uncomplicated cataract surgery with phacoemulsification and intraocular lens implantation .


After cataract surgery , 25 patients received a single instillation of timolol 0.1 % gel ( group A ) ; 20 a single instillation of timolol 0.5 % eyedrops ( group B ) ; and 25 no treatment ( group C ) .


The IOP was measured before surgery ( T0 ) and 5 minutes ( T1 ) , 2 hours 30 minutes ( T2 ) , 4 hours 30 minutes ( T3 ) , and 24 hours 180 minutes after surgery ( T4 ) .


The patients in groups A and B had lower mean IOP values than those in group C at T2 , T3 , and T4 ; IOP was higher at T2 and T3 than at T1 in the control group .


The IOP spikes in group C were higher than those observed in groups A and B : at T2 , they were observed in 40 % of the patients in group A , 30 % in group B , and 76 % in group C ; and at T3 , in respectively 20 % , 10 % , and 68 % ; and at T4 , in respectively 4 % , 0 % , and 28 % .


Timolol 0.1 % gel is as effective as timolol 0.5 % eyedrops in reducing IOP and in limiting the occurrence of IOP spikes for up to 24 hours after phacoemulsification .


To evaluate the effects of a breastfeeding intervention on primiparous mothers ' breastfeeding self-efficacy , breastfeeding duration and exclusivity at 4 and 8 weeks postpartum .


Few studies have examined the effects of breastfeeding self-efficacy on improved breastfeeding outcomes among primiparous mothers in China .


An experimental pre-test and posttest , two-group design was used in the study .


A total of 74 participants were recruited to the study from a tertiary hospital in central China , from June-October 2012 .


An individualized , standardized nursing intervention based on the Self-Efficacy Theory was delivered to enhance mothers ' breastfeeding self-efficacy , breastfeeding duration and exclusivity at 4 and 8 weeks postpartum .


Participants were randomly assigned to an intervention or referent group .


Participants in the intervention group received three individualized , self-efficacy-enhancing sessions .


Participants in the referent group received standard care .


Participants in the intervention group showed significantly greater increases in breastfeeding self-efficacy , exclusivity and duration than participants in the control group at 4 and 8 weeks postpartum ( except for duration at 4 weeks ) .


High baseline breastfeeding self-efficacy predicted higher breastfeeding self-efficacy later and more exclusive breast-feeding .


The findings in this study suggest that intervention aimed at increasing self-efficacy has a significant impact on maternal breastfeeding self-efficacy and short-term breastfeeding outcomes .


To examine risk moderation of an alcohol intervention targeting parents and adolescents .


A cluster randomized trial including 2937 Dutch early adolescents ( m = 12.68 years , SD = 0.51 ) and their parents randomized over four conditions : parent intervention , student intervention , combined parent-student intervention , and control group .


152 classes of 19 high schools in The Netherlands ( 2006 ) .


Moderators at baseline ( adolescent : gender , educational level and externalizing behavior ; parent : educational level and heavy alcohol use ) were used to examine the differential effects of the interventions on onset of ( heavy ) weekly drinking at 22-month follow-up .


The combined intervention effectively delayed the onset of weekly drinking in the general population of adolescents , and was particularly effective in delaying the onset of heavy weekly drinking in a higher-risk subsample of adolescents ( i.e. those attending lower levels of education and reporting higher levels of externalizing behavior ) .


Present and previous results have established the combined intervention to be universally effective in postponing weekly alcohol use among Dutch adolescents , with an added effect on postponing heavy weekly drinking in high risk subgroups .


Therefore , implementation of this intervention in the general population of schools in The Netherlands is advised .


NTR649 .


Knowledge among critical care nurses and their adherence to evidence-based guidelines for preventing ventilator-associated pneumonia is reported to be low .


The aim of our study was to evaluate the effectiveness of human patient simulation ( HPS ) education in the nursing management of patients requiring mechanical ventilation .


A prospective , parallel , randomized controlled trial with repeated measurements was conducted in a 22-bed adult mixed medical-surgical intensive care unit in Finland from February-October 2012 .


Thirty critical care nurses were allocated evenly to intervention and control groups ( n = 15 each ) .


The effectiveness of HPS education was evaluated through the validated Ventilator Bundle Questionnaire and Ventilator Bundle Observation Schedule at baseline and repeated twice-after the clinical and simulation settings , respectivley .


After HPS education , the average skill scores ( Ventilator Bundle Observation Schedule ) in the intervention group increased significantly ( 46.8 % -60.0 % of the total score ) in the final postintervention observation .


In the average skill scores , a linear mixed model identified significant time ( Pt < .001 ) and group ( P ( g ) = .03 ) differences and time-group interactions ( P ( t * g ) = .02 ) between the study groups after the HPS education .


In contrast , the model did not identify any significant change over time ( P ( t ) = .29 ) or time-group interactions ( P ( t ) = .69 ) between groups in average knowledge scores ( Ventilator Bundle Questionnaire ) .


Our study identified significant transfer of learned skills to clinical practice following HPS education but no influence on the level of participants ' factual knowledge .


Immediate breast reconstruction with an expander is a reasonable option for properly selected patients .


After reconstruction , patients have severe postoperative pain , which responds poorly to opioids .


Our aim was to evaluate if continuous wound infusion of a local anaesthetic into the surgical wound reduces postoperative pain , consumption of opioids and incidence of chronic pain compared to standard intravenous piritramide after primary breast reconstruction in breast carcinoma patients .


Altogether , 60 patients were enrolled in our study ; one half in the group with wound infusion of a local anaesthetic , and the other half in the standard ( piritramide ) group .


Parameters measured included : pain intensity ( visual analogue scale ) , drug requirements , alertness , hospitalisation , side-effects and late complications .


A p-value of < 0.05 was considered statistically significant .


In the recovery room , the test group reported less acute pain at rest ( P = 0.03 ) and at activity ( P = 0.01 ) , and on the day of the surgical procedure they reported less pain at activity ( P = 0.003 ) .


Consumption of piritramide and metoclopramide was lower in this group ( P < 0.0001 ) , but their alertness after the surgical procedure was higher compared to the standard group ( P < 0.001 ) .


After three months , the test group reported less chronic pain ( P = 0.01 ) .


After primary tissue expander breast reconstruction , wound infusion of a local anaesthetic significantly reduces acute pain and enables reduced opioid consumption , resulting in less postoperative sedation and reduced need for antiemetic drugs .


Wound infusion of a local anaesthetic reduces chronic pain .


To explore whether poor initial insight during a first episode of mania with psychotic features was predictive of poor psychosocial and clinical outcomes at 18 months .


Secondary analysis was performed on data collected during an 8-week RCT comparing the efficacy of olanzapine versus chlorpromazine as an adjunct to lithium , and at 18-month follow-up .


74 participants were divided into three groups ( no insight , partial insight , and full insight ) according to the insight item from the Young Mania Rating Scale ( YMRS ) .


Differences between these three groups were examined at baseline and at 18 months on measures of symptoms ( YMRS , HAMD-21 , and CGI-S ) , and social and occupational functioning ( SOFAS ) .


Baseline differences between the three groups were determined using general linear models and chi-squared analyses .


Group differences from baseline to 18-month follow-up were determined using repeated measures general linear models .


At baseline there were significant differences between the three insight groups in terms of mania and functioning , but at 18 months all groups had improved significantly in terms of psychopathology , mania , depression and social and occupational functioning .


There were no significant differences between the three groups at study completion with respect to these domains .


The study was limited by the lack of availability of a more detailed rating scale for insight , and it did not account for the duration of untreated psychosis ( DUI ) .


Poor initial insight during a first episode of mania with psychotic features does not predict poor clinical and psychosocial outcome at 18 months .


New surgical techniques and devices have been described that decrease post-tonsillectomy morbidities .


This study aimed to compare the two most popular tonsillectomy techniques .


Forty children underwent tonsillectomies using both the thermal welding and cold dissection techniques .


In each patient , one side was removed with thermal welding and the other was removed with cold dissection .


There was a significant decrease in intra-operative blood loss , and the mean operation time was significantly lower on the thermal welding side compared with the cold dissection side .


On the cold dissection side , tissue healing ( i.e. the rate of complete tissue healing ) was better and less pain was reported compared with the thermal welding side .


However , there were no significant differences between the two techniques in terms of throat pain scores on the 1st , 3rd or 14th day post-operatively , or tissue healing scores on any of the post-operative days assessed .


Cold dissection resulted in better tissue healing and lower pain scores than thermal welding , but thermal welding was associated with less intra-operative blood loss and lower mean operation time than cold dissection .


Several probiotic strains have been shown to enhance human resistance to infectious disease .


It is speculated that these strains may impose this effect by excretion of anti-microbial components , by competing with pathogens for intestinal nutrients and/or mucosal adhesion sites or modulating the immune system .


A parallel , double-blind , placebo-controlled 4-week intervention was performed in healthy males , to study the effect of a blend of probiotic bacteria ( Lactobacillus helveticus Rosell-52 , Lactobacillus rhamnosus Rosell-11 , Bifidobacterium longum ssp .


longum Rosell-175 ) and a probiotic yeast ( Saccharomyces cerevisiae var boulardii CNCM I-1079 ) on enterotoxigenic Escherichia coli ( ETEC ) challenge .


Primary outcomes studied were fecal ETEC excretion and total fecal output per day .


Subjects were randomized to the probiotic ( 5 10 ( 9 ) colony-forming units ( CFUs ) ; twice daily ; n = 30 ) or placebo group ( twice daily ; n = 30 ) .


After 2 weeks , subjects were orally challenged with a live attenuated ETEC ( 3 10 ( 9 ) CFU ) , previously demonstrated to induce mild , short-lived symptoms of a foodborne infection .


Before and after ETEC challenge , subjects collected 24h fecal samples .


Compliance to study guidelines , stool consistency ( Bristol Stool Score ) , stool frequency , and frequency and severity of gastrointestinal ( GI ) complaints were recorded by the subjects on a Daily Record Questionnaire .


ETEC challenge induced a significant increase in fecal ETEC excretion in both groups .


However , a statistically significant increase in fecal output was only observed in the probiotic group .


ETEC challenge resulted in a decrease in the percentage of fecal dry weight , and an increase in reported Bristol Stool Score , stool frequency and GI complaints .


Dietary probiotics significantly decreased the percentage of fecal dry weight .


In addition , ETEC increased C-reactive protein , total secretory Immunoglobulin A ( IgA ) and Immunoglobulin G Colonization Factor Antigen II .


Dietary probiotics did not increase resistance to oral attenuated ETEC challenge in human subjects .


To investigate the impact of three different macular carotenoid formulations on macular pigment optical density and visual performance in subjects with early age-related macular degeneration .


Fifty-two subjects were supplemented and followed for 12 months , 17 of them were in intervention Group 1 ( 20 mg/day lutein and 2 mg/day zeaxanthin ) ; 21 in Group 2 ( 10 mg/day meso-zeaxanthin , 10 mg/day lutein , and 2 mg/day zeaxanthin ) ; and 14 in Group 3 ( 17 mg/day meso-zeaxanthin , 3 mg/day lutein , and 2 mg/day zeaxanthin ) .


The macular pigment optical density was measured using customized heterochromatic flicker photometry , and visual function was assessed using corrected distance visual acuity and by letter contrast sensitivity .


A statistically significant increase in the macular pigment optical density was observed at all measured eccentricities in Group 2 ( P 0.005 ) and in Group 3 ( P < 0.05 , for all ) , but only at 1.75 in Group 1 ( P = 0.018 ) .


Statistically significant ( P < 0.05 ) improvements in letter contrast sensitivity were seen at all spatial frequencies ( except 1.2 cycles per degree ) in Group 3 , and at low spatial frequencies in Groups 1 and 2 .


Augmentation of the macular pigment optical density across its spatial profile and enhancements in contrast sensitivity were best achieved after supplementation with a formulation containing high doses of meso-zeaxanthin in combination with lutein and zeaxanthin .


In the PREDICT study , a randomised controlled trial comparing dexamethasone with prednisolone in patients with chronic inflammatory demyelinating polyradiculoneuropathy ( CIDP ) , almost a quarter of patients deteriorated soon after starting treatment .


The primary objective of this post-hoc analysis was to test the hypothesis that a focal demyelination pattern is associated with early deterioration after corticosteroid treatment and to explore whether various clinical characteristics are associated with deterioration after corticosteroid treatment .


Clinical outcome was categorised into early deterioration and non-early deterioration .


A neurophysiologist blinded for treatment outcome scored electrophysiological data into following categories : pure focal versus non-focal distribution of demyelination and no/minor versus moderate/severe sensory involvement .


Additionally , we compared electrophysiological and clinical baseline parameters , with emphasis on previously reported possible associations .


Early deterioration was found in 7 out of 33 patients ( 21 % ) .


Ten patients had pure focal distribution of demyelination , of whom 5 had early deterioration ; 23 patients had non-focal distribution , of whom 2 had early deterioration ( p = 0.02 ) .


Higher mean median nerve sensory nerve conduction velocity ( SNCV ) was found in patients with early deterioration compared to patients with non-early deterioration ( 52.6 and respectively 40.8 m/s , p = 0.02 ) .


Pure focal distribution of demyelination and lesser sensory electrophysiological abnormalities may be associated with early deterioration in CIDP patients treated with corticosteroids .


Although azacitidine ( AZA ) improves survival in patients with high-risk myelodysplastic syndrome , the overall response remains approximately 50 % .


Entinostat is a histone deacetylase inhibitor that has been combined with AZA with significant clinical activity in a previous phase I dose finding study .


Open label phase II randomized trial comparing AZA 50 mg/m ( 2 ) / d given for 10 days entinostat 4 mg/m ( 2 ) / d day 3 and day 10 .


All subtypes of myelodysplasia , chronic myelomonocytic leukemia , and acute myeloid leukemia with myelodysplasia-related changes were eligible for the study .


The primary objective was the rate of hematologic normalization ( HN ; complete remission + partial remission + trilineage hematological improvement ) .


One hundred forty-nine patients were analyzed , including 97 patients with myelodysplastic syndrome and 52 patients with acute myeloid leukemia .


In the AZA group , 32 % ( 95 % CI , 22 % to 44 % ) experienced HN and 27 % ( 95 % CI , 17 % to 39 % ) in the AZA + entinostat group .


Both arms exceeded the HN rate of historical control ( Cancer and Leukemia Group B 9221 trial ) , but only the AZA group fulfilled the primary objective of the study .


Rates of overall hematologic response were 46 % and 44 % , respectively .


Median overall survivals were 18 months for the AZA group and 13 months for the AZA + entinostat group .


The combination arm led to less demethylation compared with the monotherapy arm , suggesting pharmacodynamic antagonism .


Addition of entinostat to AZA did not increase clinical response as defined by the protocol and was associated with pharmacodynamic antagonism .


However , the prolonged administration of AZA by itself seems to increase HN rate compared with standard dosing and warrants additional investigation .


Periodic breathing ( PB ) during sleep and exercise in heart failure ( HF ) is related to respiratory acid-base status , CO2 chemosensitivity , and temporal dynamics of CO2 and O2 sensing .


We studied inhaled CO2 and acetazolamide to alter these factors and reduce PB .


We measured expired and arterial gases and PB amplitude and duration in 20 HF patients during exercise before and after acetazolamide given acutely ( 500 mg intravenously ) and prolonged ( 24 hours , 2 g orally ) , and we performed overnight polysomnography .


We studied CO2 inhalation ( 1 % -2 % ) during constant workload exercise .


PB disappeared in 19/20 and 2/7 patients during 2 % and 1 % CO2 .


No changes in cardiorespiratory parameters were observed after acute acetazolamide .


With prolonged acetazolamide at rest : ventilation +2.04 4.0 L/min ( P = .001 ) , tidal volume +0.11 1.13 L ( P = .003 ) , respiratory rate +1.24 4.63 breaths/min ( NS ) , end-tidal PO2 +4.62 2.43 mm Hg ( P = .001 ) , and end-tidal PCO2 -2.59 9.7 mm Hg ( P < .001 ) .


At maximum exercise : Watts -10 % ( P < .02 ) , VO2 -61 109 mL/min ( P = .04 ) and VCO2 101 151 mL/min ( P < .02 ) .


Among 20 patients , PB disappeared in 1 and 7 subjects after acute and prolonged acetazolamide , respectively .


PB was present 80 % 26 , 65 % 28 , and 43 % 39 of exercise time before and after acute and prolonged acetazolamide , respectively .


Overnight apnea/hypopnea index decreased from 30.8 83.8 to 21.1 16.9 ( P = .003 ) .


In HF , inhaled CO2 and acetazolamide reduce exercise PB with additional benefits of acetazolamide on sleep PB .


In the present study , `` Diabegon '' a poly-herbal preparation , with hypoglycemic activity , was evaluated for its preventive effect in metabolic syndrome subjects with type 2 diabetes and also to reveal its side effects , on liver and kidney .


Type 2 diabetic subjects with metabolic syndrome ( N = 58 ) were categorized on the basis of age and fasting blood glucose .


The grouping was as follows : Group I ( 35-50 yrs ) , Group II ( 51-65 yrs ) , Group III > 65 yrs , Group IV FBS < 145.9 , Group V FBS > 145 .


Each group was administered 4 gm of diabegon daily .


Blood glucose levels , lipid profile , liver and kidney function of the subjects were regularly monitored within 3 months of interval to 18 months .


The reduction in fasting blood glucose level ranged from 12.3 % ( P < 0.05 ) to 42 % ( P < 0.001 ) after 18 month of therapy whereas in postprandial blood glucose , the decrease ranged from 28 % ( P < 0.05 ) to 32 % ( P < 0.05 ) after 18 month of therapy .


Overall reductions in the individual parameters of the metabolic syndrome subjects were significantly higher in Group I. Cholesterol level decreased from 11 % to 27.2 % ( P < 0.001 ) , triglyceride levels decreased from 24 % to 55 % , VLDL and LDL levels reduced by 60 % & 54 % respectively after 18 months of therapy .


The HDL-C level increased in all groups .


Moreover , diabegon administration for 1.5 years exhibited no alteration in liver and kidney function tests , which indicate its non-toxicity .


Our study suggests that diabegon could be included as a preventive treatment in metabolic syndrome subjects with type 2 diabetes especially for long term treatment as it efficiently shows anti-hyperglycemic and anti-lipidemic effects with no adverse impacts on the liver and kidney .


Diet may substantially alter prostate cancer initiation and progression .


However , large-scale clinical trials of diet modification have yet to be performed for prostate cancer .


The Men 's Eating and Living ( MEAL ) Study ( CALGB 70807 [ Alliance ] ) is investigating the effect of increased vegetable consumption on clinical progression in men with localized prostate cancer .


MEAL is a randomized , phase III clinical trial designed to test whether an intervention that increases vegetable intake will decrease the incidence of clinical progression in men with clinically localized prostate cancer on active surveillance .


We are randomizing 464 patients to either a validated telephone-based diet counseling intervention or a control condition in which patients receive a published diet guideline .


The intervention will continue for two years .


The primary outcome variable is clinical progression defined by serum prostate-specific antigen ( PSA ) and pathological findings on follow-up prostate biopsy .


Secondary outcome variables include incidence of surgical and non-surgical treatments for prostate cancer , prostate-cancer related patient anxiety and health-related quality of life .


The MEAL Study is assessing the effectiveness of a high-vegetable diet intervention for preventing clinical progression in men with localized prostate cancer on active surveillance .


Current clinical assessments of motor function in Huntington 's Disease ( HD ) rely on subjective ratings such as the Unified Huntington 's Disease Rating scale ( UHDRS ) .


The ability to track disease progression using simple , objective , inexpensive , and robust measures would be beneficial .


One objective measure of motor performance is hand-tapping .


Over the last 14 years we have routinely collected , using a simple device , the number of taps made by the right and left hand over 30 seconds in HD patients attending our NHS clinics .


Here we report on a longitudinal cohort of 237 patients , which includes patients at all stages of the disease on a wide range of drug therapies .


Hand tapping in these patients declines linearly at a rate of 5.1 taps per year ( p < 0.0001 ; 95 % CI = 3.8 to 6.3 taps ) , and for each additional year of age patients could perform 0.9 fewer taps ( main effect of age : p = 0.0007 ; 95 % CI = 0.4 to 1.4 ) .


Individual trajectories can vary widely around this average rate of decline , and much of this variation could be attributed to CAG repeat length .


Genotype information was available for a subset of 151 patients , and for each additional repeat , patients could perform 5.6 fewer taps ( p < 0.0001 ; 95 % CI = 3.3 to 8.0 taps ) , and progressed at a faster rate of 0.45 fewer taps per year ( CAG by time interaction : p = 0.008 ; 95 % CI = 0.12 to 0.78 taps ) .


In addition , for each unit decrease in Total Functional Capacity ( TFC ) within individuals , the number of taps decreased by 6.3 ( 95 % CI = 5.4 to 7.1 , p < 0.0001 ) .


Hand tapping is a simple , robust , and reliable marker of disease progression .


As such , this simple motor task could be a useful tool by which to assess disease progression as well therapies designed to slow it down .


Prostate cancer screening depends on a careful balance of benefits , in terms of reduced prostate cancer mortality , and harms , in terms of overdiagnosis and overtreatment .


We aimed to estimate the effect on overdiagnosis of restricting prostate specific antigen ( PSA ) testing by age and baseline PSA .


Estimates of the effects of age on overdiagnosis were based on population based incidence data from the US Surveillance , Epidemiology and End Results database .


To investigate the relationship between PSA and overdiagnosis , we used two separate cohorts subject to PSA testing in clinical trials ( n = 1,577 and n = 1,197 ) and a population-based cohort of Swedish men not subject to PSA-screening followed for 25 years ( n = 1,162 ) .


If PSA testing had been restricted to younger men , the number of excess cases associated with the introduction of PSA in the US would have been reduced by 85 % , 68 % and 42 % for age cut-offs of 60 , 65 and 70 , respectively .


The risk that a man with screen-detected cancer at age 60 would not subsequently lead to prostate cancer morbidity or mortality decreased exponentially as PSA approached conventional biopsy thresholds .


For PSAs below 1 ng/ml , the risk of a positive biopsy is 65 ( 95 % CI 18.2 , 72.9 ) times greater than subsequent prostate cancer mortality .


Prostate cancer overdiagnosis has a strong relationship to age and PSA level .


Restricting screening in men over 60 to those with PSA above median ( > 1 ng/ml ) and screening men over 70 only in selected circumstances would importantly reduce overdiagnosis and change the ratio of benefits to harms of PSA-screening .


The purpose of the study was to compare the outcome of laparoscopic sacral colpocervicopexy with laparoscopic pectopexy .


Our aim was to show that the safety and effectiveness of the new technique is similar to the traditional technique .


We expected differences regarding defecation disorders .


We randomly assigned patients to two treatment groups : 44 in the pectopexy and 41 in the sacropexy group .


If necessary , the operative procedures were planned in a so-called multicompartment setting regarding the different pelvic floor disorders .


All defects were managed at the same time .


Eighty-one patients were examined 12 to 37 months after treatment ( mean follow-up 20.67 months ) .


The long-term follow-up ( 21.8 months for pectopexy and 19.5 months for sacropexy ) showed a clear difference regarding de novo defecation disorders ( 0 % in the pectopexy vs 19.5 % in the sacropexy group ) .


The incidence of de novo stress urinary incontinence was 4.8 % ( pectopexy ) vs 4.9 % ( sacropexy ) .


The incidence of rectoceles ( 9.5 % vs 9.8 % ) was similar in both groups .


No de novo lateral defect cystoceles were found after pectopexy , whereas 12.5 % were found after sacropexy .


The apical descensus relapse rates , 2.3 % for pectopexy vs 9.8 % for sacropexy , were not statistically significant .


The occurrence of de novo anterior defect cystoceles and rectoceles revealed no significant differences .


Laparoscopic pectopexy is a novel method of vaginal prolapse therapy that offers clear practical advantages compared with laparoscopic sacropexy .


Because laparoscopic pectopexy does not reduce the pelvic space , it results in a zero percentage of defecation disorders .


The effect of dietary macronutrient composition on the rate of gestational weight gain among women in sub-Saharan Africa is unclear .


To examine the effect of macronutrient intake on the rate of gestational weight gain among HIV-negative women in Tanzania .


The weights of 8,428 women were measured monthly from 12 weeks of gestation to term .


Prenatal dietary intake was estimated as the cumulative average of multiple 24-hour dietary recalls .


The association between energy intake and percentage of energy from carbohydrate , protein , and total fat and rate of weight gain ( grams per month ) was estimated from generalized estimating equation models .


Macronutrient effects were adjusted for total energy using the nutrient density model and maternal age , maternal height , maternal mid-upper-arm circumference , parity , marital status , maternal occupation , maternal education , household wealth , season , and treatment regimen assignment .


Body mass index ( BMI ) was considered as a confounder and a potential modifier of the effect of macronutrient intake on gestational weight gain .


A 6 g/month increase in rate of weight gain was associated with every 100-kcal increment in daily total energy intake ( 95 % CI , 1 to 12 ; p = .03 ) .