A rigorously-designed trial of universal testing and treatment ( UTT ) interventions is needed because : i ) it is unknown whether these interventions can be delivered to scale with adequate uptake ; ii ) there are many uncertainties in the models such that the population-level impact of these interventions is unknown ; and ii ) there are potential adverse effects including sexual risk disinhibition , HIV-related stigma , over-burdening of health systems , poor adherence , toxicity , and drug resistance.In the HPTN @ ( PopART ) trial , @ communities in Zambia and South Africa ( total population @ m ) will be randomly allocated to three arms .


Arm A will receive the full PopART combination HIV prevention package including annual home-based HIV testing , promotion of medical male circumcision for HIV-negative men , and offer of immediate ART for those testing HIV-positive ; Arm B will receive the full package except that ART initiation will follow current national guidelines ; Arm C will receive standard of care .


A Population Cohort of @,@ adults will be randomly selected in each community and followed for @ years to measure the primary outcome of HIV incidence .


Based on model projections , the trial will be well-powered to detect predicted effects on HIV incidence and secondary outcomes .


Trial results , combined with modelling and cost data , will provide short-term and long-term estimates of cost-effectiveness of UTT interventions .


Importantly , the three-arm design will enable assessment of how much could be achieved by optimal delivery of current policies and the costs and benefits of extending this to UTT .


Bright light treatment is effective for seasonal affective disorder ( SAD ) , although the mechanisms of action are still unknown .


We investigated whether transcranial bright light via the ear canals has an antidepressant effect in the treatment of SAD .


During the four-week study period , @ patients ( @ females ; @ males , aged @-@ , mean SD age : @ @ years ) suffering from SAD were randomized to receive a @-min daily dose of photic energy of one of three intensities ( @ lumen/@ @ mW/cm ( @ ) ; @ lumens/@ @ mW/cm ( @ ) ; @ lumens/@ @ mW/cm ( @ ) ) via the ear canals .


The light was produced using light-emitting diodes .


The severity of depressive symptoms was assessed with the Hamilton Depression Rating Scale - Seasonal Affective Disorder ( SIGH-SAD ) , the Hamilton Anxiety Rating Scale ( HAMA ) , and the Beck Depression Inventory ( BDI ) .


Cognitive performance was measured by the Trail Making Test ( TMT ) .


The within-group and between-group changes in these variables throughout the study were analysed with a repeated measures analysis of variance ( ANOVA ) , whereas gender differences at baseline within the light groups were analysed using Student 's t-tests .


Patients in all three groups showed significant decreases in their BDI , HAMA , and SIGH-SAD scores .


Response rates , i.e. , an at least @ % decrease of symptoms as measured by the BDI , were @ % -@ % in the three treatment groups .


Corresponding variations for the SIGH-SAD and the HAMA were @-@ % and @-@ % , respectively .


No intensity-based dose-response relationships in the improvement of anxiety and depressive symptoms or cognitive performance between treatment groups were observed .


Approximately one in four patients experienced mild adverse effects , of which the most common were headache , insomnia , and nausea .


These results suggests that transcranial bright light treatment may have antidepressant and anxiolytic effect in SAD patients , as both self - and psychiatrist-rated depressive and anxiety symptoms decreased in all treatment groups .


These improvements are comparable to findings of earlier bright light studies that used conventional devices .


The lack of dose response may be due to a saturation effect above a certain light intensity threshold .


Further studies on the effects of transcranial bright light with an adequate placebo condition are needed .


Suppressive therapy with levothyroxine is the main step in treatment of differentiated thyroid cancer ( DTC ) .


However , subclinical hyperthyroidism is associated with deleterious effects on cardiovascular and skeletal systems .


Metformin may have a suppressive effect on TSH level .


We performed a single blind randomized controlled trial on the effect of short term Metformin therapy on @ non-diabetic patients with DTC ( mean age of @ @ years ) under suppressive therapy with levothyroxine .


Metformin ( @ mg ) or placebo was added to the drug regimen of the patients and levothyroxine dose decreased by @ % .


TSH and thyroid hormone values were measured at the beginning of the study and @ months after treatment .


Forty-six patients had papillary and @ had follicular carcinoma .


The mean dose of levothyroxine was @ g/kg .


The mean TSH level at the beginning of the study was @ mIU/L .


The mean age , weight and baseline TSH level was not significantly different between metformin and placebo groups ( P > @ ) .


In the metformin group , the mean ( SD ) TSH level was significantly increased from @ to @ mIU/L after @ months of intervention ( P = @ ) and the mean thyroid hormone levels were significantly decreased ( P < @ ) .


In the placebo group , the mean TSH level increased from @ to @ mIU/L after @ months ( P = @ ) .


Delta TSH was @ mIU/L and @ mIU/L in metformin and placebo groups , respectively ( P = @ ) .


Adding @ mg of metformin to drug regimen was not useful to compensate for @ % of levothyroxine dose reduction in patients with DTC .


Vocal local ( VL ) is a non-pharmacological pain management technique for gynecological procedures .


In Africa , it is usually used in combination with pharmacological analgesics .


However , analgesics are associated with side-effects , and can be costly and subject to frequent stock-outs , particularly in remote rural settings .


We compared the effectiveness of VL + local anesthesia + analgesics ( the standard approach ) , versus VL + local anesthesia without analgesics , on pain and satisfaction levels for women undergoing tubal ligations in rural Kenya .


We conducted a site-randomised non-inferiority trial of @ women receiving TLs from @ Marie Stopes mobile outreach sites in Kisii and Machakos Districts .


Twenty sites provided VL + local anesthesia + analgesics ( control ) , while @ offered VL + local anesthesia without additional analgesics ( intervention ) .


Pain was measured using a validated @-point Numeric Rating Scale ; satisfaction was measured using @-point scales .


A total of @ women underwent tubal ligations with VL + local anesthesia , while @ received tubal ligations with VL + local anesthesia + analgesics .


The majority were aged @ years ( @ % ) , and had > @ children ( @ % ) .


In a multivariate analysis , pain during the procedure was not significantly different between the two groups .


The pain score after the procedure was significantly lower in the intervention group versus the control group ( by @ points ; p = @ ) .


Satisfaction scores were equally high in both groups ; @ % would recommend the procedure to a friend .


VL + local anesthesia is as effective as VL + local anesthesia + analgesics for pain management during tubal ligation in rural Kenya .


Avoiding analgesics is associated with numerous benefits including cost savings and fewer issues related to the maintenance , procurement and monitoring of restricted opioid drugs , particularly in remote low-resource settings where these systems are weak .


To evaluate the radiation dose , image quality , and influence on visual contrast of low tube voltage abdominal computed tomography ( CT ) and the effects of display setting optimization .


One hundred and fifty-seven patients were randomly assigned to one of three protocols .


Fifty-two patients underwent a @ kVp protocol , and @ and @ patients underwent low-dose protocols with @ and @ kVp , respectively .


The effective dose ( ED ) , image noise , CT attenuation , and signal-to-noise ratio ( SNR ) of each organ of each protocol were compared using Dunnett 's test .


Qualitative analysis between the protocols was also performed .


The ED of the @ and @ kVp protocols were @ % and @ % reduced , respectively .


There were no significant differences in the SNR between the protocols ( @ kVp : @ @ ; @ kVp : @ @ ; @ kVp : @ @ ; p > @ ) .


However , there were significant differences in contrast familiarity between the @ kVp images and all the other images , except @ kVp images , with optimized display settings ( p < @ ) .


In abdominal CT , an @ kVp setting offers greater radiation dose reduction than a @ kVp setting without significant deterioration of the SNR ; however , the visual contrast between the organs might be changed .


Chronic fatigue syndrome ( CFS ) is a disabling condition with unknown disease mechanisms and few treatment options .


To explore the pathophysiology of CFS and assess clonidine hydrochloride pharmacotherapy in adolescents with CFS by using a hypothesis that patients with CFS have enhanced sympathetic activity and that sympatho-inhibition by clonidine would improve symptoms and function .


Participants were enrolled from a single referral center recruiting nationwide in Norway .


A referred sample of @ adolescents with CFS was assessed for eligibility ; @ were included ( @ males and @ females ; mean age , @ years ) .


A volunteer sample of @ healthy adolescents serving as controls was included ( @ males and @ females ; mean age , @ years ) .


The CSF patients and healthy controls were assessed cross-sectionally at baseline .


Thereafter , patients with CFS were randomized @:@ to treatment with low-dose clonidine or placebo for @ weeks and monitored for @ weeks ; double-blinding was provided .


Data were collected from March @ until October @ as part of the Norwegian Study of Chronic Fatigue Syndrome in Adolescents : Pathophysiology and Intervention Trial .


Clonidine hydrochloride capsules ( @ g or @ g twice daily for body weight < @ kg or > @ kg , respectively ) vs placebo capsules for @ weeks .


Number of steps per day .


At baseline , patients with CFS had a lower number of steps per day ( P < @ ) , digit span backward score ( P = @ ) , and urinary cortisol to creatinine ratio ( P = @ ) , and a higher fatigue score ( P < @ ) , heart rate responsiveness ( P = @ ) , plasma norepinephrine level ( P < @ ) , and serum C-reactive protein concentration ( P = @ ) compared with healthy controls .


There were no significant differences regarding blood microbiology evaluation .


During intervention , the clonidine group had a lower number of steps per day ( mean difference , -@ steps ; P = @ ) , lower plasma norepinephrine level ( mean difference , -@ pg/mL ; P = @ ) , and lower serum C-reactive protein concentration ( mean ratio , @ ; P = @ ) compared with the CFS placebo group .


Adolescent CFS is associated with enhanced sympathetic nervous activity , low-grade systemic inflammation , attenuated hypothalamus-pituitary-adrenal axis function , cognitive impairment , and large activity reduction , but not with common microorganisms .


Low-dose clonidine attenuates sympathetic outflow and systemic inflammation in CFS but has a concomitant negative effect on physical activity ; thus , sympathetic and inflammatory enhancement may be compensatory mechanisms .


Low-dose clonidine is not clinically useful in CFS .


Mature data on tumor control and survival are presented from a randomized trial of the addition of a brachytherapy boost to long-course neoadjuvant chemoradiation therapy ( CRT ) for locally advanced rectal cancer .


Between March @ and November @ , @ patients with T@-@N@-@M@ rectal cancer were prospectively randomized to either long-course preoperative CRT ( @ Gy in @ fractions , per oral tegafur-uracil and L-leucovorin ) alone or the same CRT schedule plus a brachytherapy boost ( @ Gy in @ fractions ) .


The primary trial endpoint was pathologic complete response ( pCR ) at the time of surgery ; secondary endpoints included overall survival ( OS ) , progression-free survival ( PFS ) , and freedom from locoregional failure .


Results for the primary endpoint have previously been reported .


This analysis presents survival data for the @ patients in the Danish part of the trial .


In all , @ patients ( @ control arm , @ brachytherapy boost arm ) had data available for analysis , with a median follow-up time of @ years .


Despite a significant increase in tumor response at the time of surgery , no differences in @-year OS ( @ % vs @ % , hazard ratio -LSB- HR -RSB- = @ , P = @ ) and PFS ( @ % vs @ % , HR = @ , P = @ ) were observed .


Freedom from locoregional failure at @ years were @ % and @ % ( HR = @ , P = @ ) in the standard and in the brachytherapy arms , respectively .


There was no difference in the prevalence of stoma .


Explorative analysis based on stratification for tumor regression grade and resection margin status indicated the presence of response migration .


Despite increased pathologic tumor regression at the time of surgery , we observed no benefit on late outcome .


Improved tumor regression does not necessarily lead to a relevant clinical benefit when the neoadjuvant treatment is followed by high-quality surgery .


The goals of this study were to investigate the difference in responses between a scuba dive preceded by aerobic exercise ( EX ) and a nonexercise control dive ( CON ) and to further evaluate the potential relation between venous gas emboli ( VGE ) and microparticles ( MP ) .


We hypothesized that exercise would alter the quantity and subtype of annexin V-positive MP and VGE .


Nineteen divers performed two dives to @ m seawater for @ min separated by at least @ d , one of which was preceded by @ min of treadmill interval exercise .


Blood was obtained before exercise , before diving , and @ min , @ h , @ h , and @ h after surfacing .


Intravascular bubbles were quantified by transthoracic echocardiography at @ , @ , @ , and @ min .


The median VGE remained unchanged between the two dives ; however , there was a significant increase in VGE in the exercise dive at @ and @ min at rest .


MP were significantly elevated by approximately @ times at all time points after CON compared with those after EX .


Markers of neutrophil and platelet activation were elevated by both dives , and these elevations were attenuated in the EX dive .


We conclude that some of the differences observed between the EX and CON related to MP and platelet and neutrophil activation provide additional insight into the potential protective benefits of exercise ; however , further study is needed to understand the mechanism and true potential of these benefits .


Although previous randomized clinical trials established a basis for lipid guidelines worldwide , they employed fixed doses of statins throughout trials ( fire-and-forget approach ) .


In the real clinical setting , however , statin doses are titrated to achieve target low-density lipoprotein cholesterol ( LDL-C ) levels ( treat-to-target approach ) .


The major objective was to investigate whether intensive lipid-lowering therapy using the treat-to-target approach yielded greater regression of aortic plaques .


We therefore performed a prospective , randomized trial comparing the effects of standard ( achieve LDL-C levels recommended by the Japanese guidelines ) and intensive ( achieve @ % lower LDL-C levels than standard ) rosuvastatin therapy for @ year in @ hypercholesterolemic patients with a primary endpoint of aortic atherosclerotic plaques evaluated by non-invasive magnetic resonance imaging ( MRI ) .


Average doses were @ @ and @ @ mg/day for standard ( n = @ ) and intensive therapy group ( n = @ ) , respectively .


Although both therapies significantly reduced LDL-C and high-sensitivity C-reactive protein ( hsCRP ) levels , LDL-C reduction was significantly greater in the intensive group ( -@ vs. -@ % ) .


MRI study showed that thoracic aortic plaques were significantly regressed in both groups , with greater regression of thoracic plaque in the intensive group ( -@ vs. -@ % , p = @ ) .


Multivariate analyses revealed that thoracic plaque regression was significantly correlated with hsCRP reduction , but not with changes in serum lipids , endothelial function , or doses of rosuvastatin .


Intensive statin therapy with titration targeting lower LDL-C levels resulted in greater thoracic aortic plaque regression compared to standard therapy , which was correlated with hsCRP reduction , suggesting that intensive statin therapy could provide better clinical outcomes .


To evaluate the efficacy and tolerability of pregabalin in postoperative pain management after laparoscopic cholecystectomy ( LC ) .


A prospective , randomized , placebo , controlled , double-blinded study was conducted at Anesthesia Department , Laparoscopy Surgery Unit , Ain Shams University Hospital .


Ninety patients with ASA physical status I-II scheduled for elective LC under general anesthesia were included .


Patients were randomly assigned to the following groups ( n = @ each ) : pregabalin group ( P ) , received @ mg pregabalin capsules @ hours preoperatively , @ hours postoperatively , and twice daily for @ days ; gabapentin group ( G ) , received @ mg gabapentin capsules ( @ mg , @ ) @ hours preoperatively , @ hours postoperatively , and @ mg three times daily for @ days ; and control group ( C ) , received placebo capsules .


Postoperative pain scores were recorded on a visual analogue scale .


The following data were recorded : total daily pethidine and diclofenac consumption , numeric sedation score , and the postoperative nausea , vomiting , and dizziness scores .


The @-hour pethidine consumption was significantly lower ( P < @ ) in both pregabalin and gabapentin groups versus control .


Both groups had significantly less ( P < @ ) patients with postoperative nausea , vomiting , sedation , and dizziness versus control .


Overall patient satisfaction with pain management was significantly higher ( P < @ ) in pregabalin group versus gabapentin or control groups .


Gabapentin @ mg and pregabalin @ mg are effective and safe analgesics for reducing postoperative pain in LC .


The perioperative oral administration of pregabalin @ mg in patients undergoing LC is an effective and safe method of analgesia with a low incidence of adverse effects and reduces postoperative pethidine consumption .


The aim of the study was to investigate the influence of different driving scenarios ( urban , rural , highway ) on the timing required by drivers from a two-stage warning system , based on car-to-car communication .


Car-to-car communication systems are designed to inform drivers of potential hazards at an early stage , before they are visible to them .


Here , questions arise as to how drivers acknowledge early warnings and when they should be informed ( first stage ) and warned ( second stage ) .


Hence , optimum timing for presenting the information was tested .


A psychophysical method was used to establish the optimum timing in three driving scenarios at different speed limits ( urban : @ km/h , rural : @ km/h , highway : @ km/h ) .


A total of @ participants ( @ female , @ male ; M = @ years , SD = @ years ) participated in the study .


The results showed that the optimum timing did not differ among the three scenarios.The first and second stages should ultimately be presented at different timings at each speed limit ( first stage : @ s , second stage : @ s before a potential hazard ) .


The results showed that well-selected timing for activating information and warning is crucial for the acceptance of these systems .


Appropriate timing for presenting the information and warning can be derived for these systems .


The findings will be integrated in further development of assistance systems based on car-to-x technology within the Car@X-Safety project of the Niederschsisches Forschungszentrum Fahrzeugtechnik in Germany.This study was also supported by Chalmers University of Technology in Sweden .


Conducting randomized controlled trials on traditional Chinese non-drug therapies has been limited by factors such as patient preference to specific treatment modality .


The aim of this study is to investigate the feasibility of applying a partially randomized patient preference ( PRPP ) trial model in evaluating the efficacy of two types of traditional Chinese medicine therapies , acupuncture and cupping , for fibromyalgia while accounting for patients ' preference of either therapeutic modality .


This protocol was approved by the Institutional Ethics Committee of affiliated Dongfang Hospital , Beijing University of Chinese Medicine ( approval number : @-@ ) .


One hundred participants with fibromyalgia will be included in this study .


Diagnosis of fibromyalgia will be based on the American College of Rheumatology criteria .


Before treatment , participants will be interviewed for their preference toward acupuncture or cupping therapy .


Fifty participants with no preference will be randomly assigned to one of the two groups and another @ participants with strong preference to either acupuncture or cupping will receive what they choose .


For acupuncture and cupping therapy , the main acupoints used will be tender points ( Ashi ) .


Treatment will be three times a week for @ consecutive weeks with a follow-up period of @weeks .


Outcome measures will be qualitative ( patient expectation and satisfaction ) and quantitative ( pain intensity , quality of life , depression assessment ) .


Adequate postoperative analgesia may enhance recovery .


The efficacy of continuous wound infusion vs intermittent epidural ropivacaine for postoperative analgesia was investigated .


Prospective randomized , observer blind trial .


Aretaieio University Hospital .


Patients scheduled for open abdominal hysterectomy or myomectomy .


Patients received @ mL of @ % ropivacaine along the skin incision before skin closure , followed by wound infusion @ mL/hour of @ % ropivacaine or epidurally @ mL of @ % ropivacaine in the beginning of surgery followed by @ mL of @ % ropivacaine @ hourly .


The epidural injections or the wound infusion of ropivacaine lasted @ hours .


Rescue analgesia consisted of patient-controlled analgesia morphine up to @ hours and acetaminophen/codeine tablets the next @ hours .


Analgesic consumption and visual analog scale pain at rest and during cough were assessed @ , @ , @ , @ , @ , and @ hours postoperatively .


One and three months later , patients were interviewed by phone for analgesic consumption at home and presence of pain .


The subcutaneous group consumed more morphine during the first @ , @ , and @ hours postoperatively ( P < @ , P < @ , and P < @ , respectively ) .


Subsequent morphine and acetaminophen/codeine requirements did not differ between the two groups .


Pain intensity during cough was higher only @ hours after surgery in the subcutaneous group ( P = @ ) .


Three months postoperatively , the two groups did not differ in the analgesic requirements and presence of persisting and/or burning pain .


Based on our results , there is no clinical significant difference between the epidural ropivacaine and the subcutaneous ropivacaine group or a clear superiority to one management strategy .


An @-month randomized , controlled prospective study evaluated , in an intra-individual comparison , the clinical performance of two-step etch-and-rinse adhesives in non-carious cervical lesions ( NCCL ) .


@ subjects , with at least two similar sized NCCL participated in this study .


After sample size calculation , @ restorations were placed , according to one of the following groups : Adper Single Bond @ ( SB ) and Ambar ( AM ) .


The restorations were placed incrementally using a resin composite ( Opallis ) .


The restorations were evaluated at baseline and after @ and @ months according to the FDI criteria .


The differences in the ratings of the two materials after @ and @ months were tested with Fisher 's exact test ( = @ ) , and the performance of the each material at baseline and after @ and @ months was evaluated by Wilcoxon test ( = @ ) .


All subjects attended the @-month recall .


No significant differences were observed between the materials for any criteria evaluated .


Only four restorations ( two from each material ) were lost after @ months .


Thus , the retention rates of both materials at @ months were @ % ( @ % CI @-@ % ) .


Nine restorations ( four Ambar and five Adper Single Bond @ ) showed marginal discoloration which was solved with a polishing procedure .


Both adhesive systems showed acceptable clinical retention rates after @ months .


The leading mental health causes of the global burden of disease are depression in women and alcohol use disorders in men .


A major hurdle to the implementation of evidence-based psychological treatments in primary care in developing countries is the non-availability of skilled human resources .


The aim of these trials is to evaluate the effectiveness and cost-effectiveness of two psychological treatments developed for the treatment of depression and alcohol use disorders in primary care in India .


This study protocol is for parallel group , randomized controlled trials ( Healthy Activity Program for moderate to severe depression , Counselling for Alcohol Problems for harmful and dependent drinking ) in eight primary health centres in Goa , India .


Adult primary care attendees will be screened with the Patient Health Questionnaire for depression and , in men only , the Alcohol Use Disorders Identification Test for drinking problems .


Screen-positive attendees will be invited to participate ; men who screen positive for both disorders will be invited to participate in the Counselling for Alcohol Problems trial .


Those who consent will be allocated in a @:@ ratio to receive either the respective psychological treatment plus enhanced usual care or enhanced usual care only using a computer generated allocation sequence , stratified by primary health centre and , for depression , by sex .


The enhanced usual care comprises providing primary health centre doctors with contextualized World Health Organization guidelines and screening results .


Psychological treatments will be delivered by lay counsellors , over a maximum period of three months .


Primary outcomes are severity of disorder and remission rates at three months post-enrolment and , for the Counselling for Alcohol Problems trial , drinking and the impact of drinking on daily lives .


Secondary outcomes include severity of disorder and remission rates at @months , disability scores , suicidal behaviour and economic impact , and cost-effectiveness at three and @months .


@ participants with depression and @ participants with harmful drinking will be recruited .


Primary analyses will be intention-to-treat .


These trials may offer a new approach for the treatment of moderate-severe depression and drinking problems in primary care that is potentially scalable as it relies on delivery by a single pool of lay counsellors .


To compare WHO first-line antiretroviral therapy ( ART ) with nonnucleoside reverse transcriptase inhibitors ( NNRTI ) - based regimen with a boosted protease inhibitor ( bPI ) regimen in a resource-limited setting regarding treatment outcome and emergence of drug resistance mutations ( DRMs ) .


Treatment-naive adults were randomized to nevirapine ( NVP ) or ritonavir-boosted lopinavir ( LPV/r ) regimens each in combination with tenofovir ( TDF ) / emtricitabine ( FTC ) or zidovudine ( ZDV ) / lamivudine ( @TC ) .


Primary endpoint was the incidence of therapeutical ( clinical and/or virologic ) failure at week @ with follow-up till week @ .


Four hundred and twenty-five patients ( @ men ; @ women ) received at least one dose of the study drug .


mITT analysis showed no difference in proportion of therapeutical failure between treatment arms -LSB- @/@ ( @ % ) in NVP vs. @/@ ( @ % ) LPV/r at week @ ( P = @ ) ; @/@ ( @ % ) in NVP vs. @/@ ( @ % ) in LPV/r at week @ ( P = @ ) -RSB- .


Per-protocol analysis demonstrated significantly more virologic failure with NVP than with LPV/r regimens -LSB- at week @ : @/@ ( @ % ) vs. @/@ ( @ % ) , P = @ ; at week @ : @/@ ( @ % ) vs. @/@ ( @ % ) , P = @ ) -RSB- .


Drug resistance mutations to NNRTI were detected in @ out of @ ( @ % ) and dual-class resistance to nucleoside reverse transcriptase inhibitor ( NRTI ) and NNRTI in @ out of @ ( @ % ) of NVP failing patients .


K@R mutation was present in seven out of @ patients failing NVP-TDF/FTC regimen .


No major protease inhibitor-DRM was detected among LPV/r failing patients .


Discontinuation for adverse events was similar between treatment groups .


In resource-limited settings , first-line NNRTI-NRTI regimen as compared with bPI-based regimen provides similar outcome but is associated with a significantly higher number of virologic failure and resistance mutations in both classes that jeopardize future options for second-line therapy .


We carried out an open randomized controlled study to explore the changes in the rate of speech recovery and BDNF concentrations in patients with left-hemisphere stroke and carbohydrate metabolism disorders ( diabetes mellitus type@ or prediabetes ) who received cerebrolysin .


A study included @ inpatients of the Center of Speech Pathology and Neurorehabilitation .


Neuropsychological examination was performed at baseline and after the treatment was completed .


We determined aphasia type and quantitatively assessed speech in scores which reflected the severity of speech impairment .


BDNF serum concentrations were measured .


Clinical efficacy of cerebrolysin ( intravenously in dose @ ml in @ ml of physiological solution , @ days a week , during @ weeks ) used in addition to standard neurorehabilitation measures in patients with post stroke aphasia of different severity was demonstrated .


This treatment was most effective in patients with very marked and marked speech impairment that was confirmed by the maximal possible improvement of speech during the first course of neurorehabilitation measures , in particular in a subgroup of patients without carbohydrate metabolism disorders .


A significant increase in BDNF concentrations was an additional evidence of this improvement .


The use of cerebrolysin in the complex treatment of patients with post stroke aphasia of different severity improves the prognosis of their rehabilitation .


Although repeat radiation treatment has been shown to palliate pain in patients with bone metastases from multiple primary origin sites , data for the best possible dose fractionation schedules are lacking .


We aimed to assess two dose fractionation schedules in patients with painful bone metastases needing repeat radiation therapy .


We did a multicentre , non-blinded , randomised , controlled trial in nine countries worldwide .


We enrolled patients @ years or older who had radiologically confirmed , painful ( ie , pain measured as @ points using the Brief Pain Inventory ) bone metastases , had received previous radiation therapy , and were taking a stable dose and schedule of pain-relieving drugs ( if prescribed ) .


Patients were randomly assigned ( @:@ ) to receive either @ Gy in a single fraction or @ Gy in multiple fractions by a central computer-generated allocation sequence using dynamic minimisation to conceal assignment , stratified by previous radiation fraction schedule , response to initial radiation , and treatment centre .


Patients , caregivers , and investigators were not masked to treatment allocation .


The primary endpoint was overall pain response at @ months , which was defined as the sum of complete and partial pain responses to treatment , assessed using both Brief Pain Inventory scores and changes in analgesic consumption .


Analysis was done by intention to treat .


This study is registered with ClinicalTrials.gov , number NCT@ .


Between Jan @ , @ , and May @ , @ , we randomly assigned @ patients to each treatment group .


@ ( @ % ) patients in the @ Gy group and @ ( @ % ) in the @ Gy group were found to be ineligible after randomisation , and @ ( @ % ) and @ ( @ % ) patients , respectively , were not assessable at @ months and were counted as missing data in the intention-to-treat analysis .


In the intention-to-treat population , @ ( @ % ) patients allocated to @ Gy treatment and @ ( @ % ) allocated to @ Gy treatment had an overall pain response to treatment ( p = @ ; response difference of @ % -LSB- upper limit of the @ % CI @ , less than the prespecified non-inferiority margin of @ % -RSB- ) .


In the per-protocol population , @ ( @ % ) of @ patients and @ ( @ % ) of @ patients , respectively , had an overall pain response to treatment ( p = @ ; response difference @ % -LSB- upper limit of the @ % CI @ , greater than the prespecified non-inferiority margin of @ % -RSB- ) .


The most frequently reported acute radiation-related toxicities at @ days were lack of appetite ( @ -LSB- @ % -RSB- of @ assessable patients who received @ Gy vs @ -LSB- @ % -RSB- of @ assessable patients who received @ Gy ; p = @ ) and diarrhoea ( @ -LSB- @ % -RSB- of @ vs @ -LSB- @ % -RSB- of @ ; p = @ ) .


Pathological fractures occurred in @ ( @ % ) of @ patients assigned to @ Gy and @ ( @ % ) of @ assigned to @ Gy ( odds ratio -LSB- OR -RSB- @ , @ % CI @-@ ; p = @ ) , and spinal cord or cauda equina compressions were reported in seven ( @ % ) of @ versus two ( < @ % ) of @ , respectively ( OR @ , @ % CI @-@ ; p = @ ) .


In patients with painful bone metastases requiring repeat radiation therapy , treatment with @ Gy in a single fraction seems to be non-inferior and less toxic than @ Gy in multiple fractions ; however , as findings were not robust in a per-protocol analysis , trade-offs between efficacy and toxicity might exist .


The combination of midazolam and opioid has been widely used as a standard sedative regimen for endoscopic retrograde cholangiopancreatography ( ERCP ) .


Following recent evidence that dexmedetomidine may exert a synergistic effect in combination with midazolam , this study compared the sedative effect and adverse events of midazolam-meperidine-dexmedetomidine ( MMD ) and midazolam-meperidine during ERCP .


A total of @ patients who were scheduled for ERCP were prospectively enrolled and randomly assigned , in a double-blind manner , to the MMD ( n = @ ) or midazolam-meperidine ( n = @ ) groups .


Each patient received an intravenous ( IV ) bolus dose of midazolam and meperidine ( @ mg/kg and @mg , @ % reduction and @mg for patients aged @ years , respectively ) .


To this dose , a continuous IV infusion of dexmedetomidine ( @g/kg/h ; MMD group ) or the same volume of normal saline ( midazolam-meperidine group ) was added .


The sedation level ( Ramsay Sedation Scale -LSB- RSS -RSB- ) as well as hemodynamic and respiratory changes were assessed .


Adequate sedation ( RSS@ ) was maintained during ERCP in @ % and @ % of the MMD and midazolam-meperidine group , respectively ( P < @ ) .


RSS scores were significantly higher in the MMD group ( P < @ ) .


Intraoperative bispectral index scores were significantly lower in the MMD group ( P < @ ) than in the midazolam-meperidine group.Lower additional ( P = @ ) and total ( P = @ ) doses of midazolam were required in the MMD group.Patients in the MMD group showed lower pain scores ( P < @ ) and higher satisfaction scores ( P < @ ) .


Desaturation occurred more frequently in the midazolam-meperidine group ( @ vs. @ ; P = @ ) .


The addition of dexmedetomidine to the midazolam-meperidine regimen provided better sedative efficacy and a superior safety profile during ERCP compared with a midazolam-meperidine regimen.This trial was registered at ClinicalTrials.gov Identifier ( NCT@ ) .


The transient receptor potential vanilloid @ has been implicated as a target mediator for heartburn perception and modulation of esophageal secondary peristalsis .


Our aim was to determine the effect of repeated esophageal infusion of capsaicin-contained red pepper sauce on heartburn perception and secondary peristalsis in healthy adults .


Secondary peristalsis was performed with mid-esophageal injections of air in @ healthy adults .


Two separate protocols including esophageal infusion with saline and capsaicin-contained red pepper sauce and @ consecutive sessions of capsaicin-contained red pepper sauce were randomly performed .


After repeated infusion of capsaicin-contained red pepper sauce , the threshold volume to activate secondary peristalsis was significantly increased during slow ( p < @ ) and rapid air injections ( p = @ ) .


Acute infusion of capsaicin-contained red pepper sauce enhanced heartburn perception ( p < @ ) , but the intensity of heartburn perception was significantly reduced after repeated capsaicin-contained red pepper sauce infusion ( p = @ ) .


Acute infusion of capsaicin-contained red pepper sauce significantly increased pressure wave amplitudes of distal esophagus during slow ( p = @ ) and rapid air injections ( p = @ ) , but repeated infusion of capsaicin-contained red pepper sauce significantly decreased pressure wave amplitude of distal esophagus during slow ( p = @ ) and rapid air injections ( p = @ ) .


Repeated esophageal infusion of capsaicin appears to attenuate heartburn perception and inhibit distension-induced secondary peristalsis in healthy adults .


These results suggest capsaicin-sensitive afferents in modulating sensorimotor function of secondary peristalsis in human esophagus .


This study was conducted to determine if intravenous dexamethasone combined with caudal block was able to prolong post-operative analgesia in pediatric daycare surgeries .


Sixty four ASA I or II children aged @ to @ year old scheduled for daycare open unilateral herniotomy received general anesthesia and caudal block using @ % levobupivacaine @ mg.kg ( -@ ) with suppository paracetamol @ mg.kg ( -@ ) .


After anesthesia induction , they were randomized to receive either intravenous dexamethasone @ mg.kg ( -@ ) ( Group I ) or same volume intravenous normal saline ( Group II ) .


Postoperatively , pain scores were assessed using Wong - Baker faces scale .


At home , their parents assessed and recorded the pain scores , time to first oral paracetamol served and frequency of paracetamol given in two consecutive days post surgery .


On the third postoperative day , these information were gathered from the parents via a phone call .


There were statistically significant differences between Group I and Group II in the median time to first paracetamol ( @ vs @ min , p = @ ) , mean pain scores postoperative day @ ( @ @ vs @ @ , p = @ ) , mean pain score-postoperative day @ ( @ @ vs @ @ , p = @ ) and mean frequencies of paracetamol given on postoperative day @ ( @ @ vs @ @ , p = @ ) .


A single intravenous dexamethasone dose when combined with caudal block reduces postoperative pain , decreases paracetamol requirement and prolongs analgesic duration in children after open herniotomy .


The liver is an important organ for various aspects of glucose metabolism , including glucose uptake , storage , and synthesis .


It is a major organ in the metabolic process with perfusion provided by both the portal vein and hepatic artery .


In diabetic patients organ perfusion is reduced and this is linked to atherosclerosis , and as a result complications occur .


In this study , we aimed to evaluate liver perfusion by scintigraphic methods in diabetic patients .


We retrospectively investigated @,@ myocardial perfusion scintigraphies taken between January @ and December @ at Canakkale Onsekiz Mart University Medical Faculty Nuclear Medicine Department .


A total of @ patients who were diagnosed with diabetes mellitus and had myocardial perfusion scintigraphies were included in the study .


The control subjects included @ patients without diabetes mellitus who were chosen at random .


Patients with chronic liver disease were not included in the study .


The values from liver regions of interest ( liver-ROI ) rates and heart regions of interest ( heart-ROI ) rates were compared between the patients and controls .


Patients were grouped according to the presence of diabetes .


In the diabetes mellitus group , the liver-ROI average was lower ( p = @ ) than in the controls .


In the control group , the average liver-ROI/heart-ROI ratios were higher than the ratio in the diabetes mellitus group ( p = @ ) .


Multivariate variance analysis showed that the diabetes mellitus liver-ROI/heart-ROI ratio was independent of other risk factors ( p = @ ; F : @ ) .


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This study shows that liver perfusion in diabetic patients is reduced compared with those without diabetes .


Prospective studies with larger patient groups are required .


There is no consensus on the importance of visit-to-visit glycemic variability in diabetes .


Therefore , we assessed the effects of visit-to-visit variability ( VVV ) in HbA@c and fasting glucose on major outcomes in the ADVANCE ( Action in Diabetes and Vascular Disease : Preterax and Diamicron MR Controlled Evaluation ) trial .


ADVANCE was a factorial randomized controlled trial of intensive glucose control and blood pressure lowering in patients with type @ diabetes .


VVV in the intensive glucose treatment group was defined using the SD of five measurements of HbA@c and glucose taken @-@ months after randomization .


Outcomes were combined macro - and microvascular events and all-cause mortality occurring post @ months .


Sensitivity analyses were performed using other indices of variability and in the standard glucose treatment group .


Among @,@ patients in the intensive group , an increase in VVV of HbA@c was associated with an increased risk of vascular events ( P = @ ) and with mortality ( P < @ ) : highest versus lowest tenth hazard ratio ( @ % CI ) @ ( @-@ @ ) and @ ( @-@ @ ) , respectively , after multivariable adjustment .


A clear association was also observed between VVV of fasting glucose and increased risk of vascular events ( P < @ ; @ -LSB- @-@ @ -RSB- ) .


HbA@c variability was positively associated with the risk of macrovascular events ( P = @ for trend ) , whereas glucose variability was associated with both macro - and microvascular events ( P = @ and P < @ for trend , respectively ) .


Sensitivity analyses using other indices , and patients in the standard glucose treatment group , were broadly consistent with these results .


Consistency of glycemic control is important to reduce the risks of vascular events and death in type @ diabetes .


Insulin initiation and titration in primary care is necessary to respond to the growing epidemic of type @ diabetes ( T@D ) .


The INITIATION study aims to evaluate the impact of implementing a new model of care with Primary Care Physician and Practice Nurse ( PN ) teams supported by a Credentialed Diabetes Educator-Registered Nurse ( CDE-RN ) and endocrinologist in initiating and titrating basal and prandial insulin for T@D patients in the Australian healthcare system over @weeks .


This study also explores the feasibility and efficacy of retrospective continuous glucose monitoring ( r-CGM ) in comparison with self-monitoring of blood glucose ( SMBG ) among people with T@D in primary care .


The study employs a before and after design with a nested exploratory trial of SMBG and r-CGM .


A total of @ insulin nave T@D patients with a glycated haemoglobin ( HbA@c ) level of > @ % in the previous @months while treated with maximal oral therapy will be recruited and screened from @ primary care practices in Melbourne , Australia .


All patients will be commenced on a basal insulin regimen following randomization into one of the two blood glucose monitoring arms , with intensification to a `` basal plus '' regimen if required .


The outcomes of the new model of care will be benchmarked with data collected over the same period from a specialist setting in Melbourne , Australia .


This article describes the study protocol and insulin treatment algorithm employed in the first study to explore r-CGM use among T@D in primary care .


Findings from the INITIATION study will inform development of a larger randomized controlled trial .


Integrative neuromuscular training ( INT ) has successfully enhanced physical fitness and reduced abnormal biomechanics , which appear to decrease injury rates in adolescent female athletes .


If not addressed at the proper time , low levels of physical fitness and abnormal mechanics may predispose female athletes to an increased risk of musculoskeletal injuries .


To evaluate sex-specific effects of INT on selected measures of health - and skill-related fitness in children during physical education ( PE ) .


Cohort study .


Public primary school .


Forty children ( @ boys , @ girls ; age = @ @ years , height = @ @ cm , mass = @ @ kg ) from @ second-grade PE classes .


The classes were randomized into the PE-plus-INT group ( @ boys , @ girls ) or the control group ( @ boys , @ girls ) that participated in traditional PE .


The INT was performed @ times per week during the first approximately @ minutes of each PE class and consisted of body weight exercises .


Push-up , curl-up , standing long jump , single-legged hop , single-legged balance , sit-and-reach flexibility test , shuttle run , and @-km run .


At baseline , the boys demonstrated higher levels of performance in most of the fitness measurements as evidenced by greater performance on the push-up , standing long jump , single-legged hop , shuttle run , and @-km run ( P < @ ) .


In the evaluation of the training effects , we found intervention effects in the girls for enhanced INT-induced gains in performance relative to the control group on the curl-up , long jump , single-legged hop , and @-km run ( P < @ ) after controlling for baseline .


Boys did not demonstrate similar adaptations from the INT program ( P @ ) .


These data indicate that INT is an effective and time-efficient addition to PE for enhancing motor skills and promoting physical activity in children .


Seven-year-old girls appeared to be more sensitive to the effects of INT than @-year-old boys .


Future research is warranted to confirm these effects in larger cohorts of children .


To evaluate ranibizumab @ mg using bimonthly monitoring and individualized re-treatment after monthly follow-up for @ months in patients with visual impairment due to diabetic macular edema ( DME ) .


A phase IIIb , @-month , prospective , open-label , multicenter , single-arm study in the United Kingdom .


Participants ( N = @ ) with visual impairment due to DME .


Participants received @ initial monthly ranibizumab @ mg injections ( day @ to month @ ) , followed by individualized best-corrected visual acuity ( BCVA ) and optical coherence tomography-guided re-treatment with monthly ( months @-@ ) and subsequent bimonthly follow-up ( months @-@ ) .


Laser was allowed after month @ .


Mean change in BCVA from baseline to month @ ( primary end point ) , mean change in BCVA and central retinal thickness ( CRT ) from baseline to month @ , gain of @ and @ letters , treatment exposure , and incidence of adverse events over @ months .


Of @ participants , @ ( @ % ) and @ ( @ % ) completed the @ and @ months of the study , respectively .


The mean age was @ years , the mean duration of DME was @ months , and @ % of the participants had received prior laser treatment ( study eye ) .


At baseline , mean BCVA was @ letters , @ % of patients had a baseline BCVA of > @ letters , and mean baseline CRT was @ m , with @ % of patients having a baseline CRT < @ m.


The mean change in BCVA from baseline to month @ was +@ letters ( @ % confidence interval -LSB- CI -RSB- , @-@ @ ) , and after institution of bimonthly treatment the mean change in BCVA at month @ was +@ letters ( @ % CI , @-@ @ ; P < @ ) and +@ letters ( @ % CI , @-@ @ ) at month @ .


The proportion of participants gaining @ and @ letters was @ % and @ % at month @ and @ % and @ % at month @ , respectively .


Participants received a mean of @ and @ injections over @ and @ months , respectively .


No new ocular or nonocular safety findings were observed during the study .


The BCVA gain achieved in the initial @-month treatment period was maintained with an additional @ months of bimonthly ranibizumab PRN treatment .


The highest risk for invasive meningococcal disease ( IMD ) is in infants aged < @ year .


Quadrivalent meningococcal conjugate vaccination has the potential to prevent IMD caused by serogroups A , C , W and Y.


This phase @b , multinational , open-label , randomized , parallel-group , multicenter study evaluated the safety of a @-dose series of MenACWY-CRM , a quadrivalent meningococcal conjugate vaccine , concomitantly administered with routine vaccinations to healthy infants .


Two-month-old infants were randomized @:@ to receive MenACWY-CRM with routine vaccines or routine vaccines alone at ages @ , @ , @ and @ months .


Adverse events ( AEs ) that were medically attended and serious adverse events ( SAEs ) were collected from all subjects from enrollment through @ months of age .


In a subset , detailed safety data ( local and systemic solicited reactions and all AEs ) were collected for @ days post vaccination .


The primary objective was a non-inferiority comparison of the percentages of subjects with @ severe systemic reaction during Days @-@ after any vaccination of MenACWY-CRM plus routine vaccinations versus routine vaccinations alone ( criterion : upper limit of @ % confidence interval -LSB- CI -RSB- of group difference < @ % ) .


A total of @ subjects were randomized with @ in the detailed safety arm .


The percentage of subjects with severe systemic reactions was @ % after MenACWY-CRM plus routine vaccines and @ % after routine vaccines alone ( group difference @ % ( @ % CI -@ , @ % ) .


Although the non-inferiority criterion was not met , post hoc analysis controlling for significant center and group-by-center differences revealed that MenACWY-CRM plus routine vaccinations was non-inferior to routine vaccinations alone ( group difference -@ % -LSB- @ % CI -@ % , @ % -RSB- ) .


Rates of solicited AEs , medically attended AEs , and SAEs were similar across groups .


In a large multinational safety study , a @-dose series of MenACWY-CRM concomitantly administered with routine vaccines was clinically acceptable with a similar safety profile to routine vaccines given alone .


Endoscopic papillary balloon dilation ( EPBD ) was associated with a higher rate of endoscopic retrograde cholangiopancreatography ( ERCP ) pancreatitis ( PEP ) .


The purpose of this study was to determine whether placement of an endoscopic nasobiliary drainage ( ENBD ) catheter can also prevent PEP after EPBD .


A total of @ patients , who with proven common bile duct ( CBD ) stones , received EPBD were enrolled this trial .


They were randomly divided into ENBD group ( n = @ ) and no-ENBD group ( n = @ ) according whether undergone an ENBD procedure after EPBD .


Their demographics , laboratory , procedural data were collected , and pancreaticobiliary complications were followed .


The number of patients with serum amylase levels above the normal upper limit ( > @ U/L ) did not differ between groups .


However , compared with ENBD group , more patients in No-ENBD group had levels greater than three times the normal limit ( > @ U/L ) ( @/@ vs @/@ , P = @ ) , and more patients developed to PEP ( @/@ vs @/@ , P = @ ) .


During follow-up , the numbers of patients undergone cholecystectomy , cholangitis and recurrence of CBD stones were similar .


There was also no significant difference in the cumulative rate of recurrent pancreaticobiliary complications between the two groups ( P = @ ) .


EPBD followed by insertion of an ENBD catheter can prevent PEP , and routine ENBD catheter placement is recommended after an EPBD procedure .


Use of pneumococcal conjugate vaccines ( PCVs ) in resource-poor countries has focused on early infant immunisation with little emphasis on protection in late infancy and beyond .


Boosting of the immune response later in infancy might provide improved persistence of immunogenicity into early childhood , however data are scarce .


The aim of this study was to investigate if a two-dose prime with booster at age @ months compared with a three-dose prime-only PCV schedule provided non-inferior immunogenicity in early infancy and superior persistence of antibody responses in early childhood .


We did an open-label , randomised , parallel group , controlled trial in healthy infants aged @-@ days from Kathmandu , Nepal .


Participants were randomly allocated ( @:@:@ ratio ) to receive PCV@ in addition to routine immunisations either as a two-dose prime and boost ( @ +@ ) , three-dose prime ( @ +@ ) , or two doses after completion of the initial study phase ( @ +@ ) .


We used a computer generated randomisation list with randomly varying block sizes .


We followed up participants at age @-@ years together with a group of unvaccinated controls .


Sera were analysed for opsonophagocytic activity , protein D , and PCV@ serotype-specific IgG .


Laboratory staff was masked to intervention group assignment .


The primary outcome measure was to determine the proportion of participants in the @ +@ group at age @ months with specific IgG for serotypes @ , @ , and @ of at least @ g/mL in the per-protocol population .


The secondary outcomes were non-inferiority ( within @ % levels ) at age @ weeks for the proportion of participants in the @ +@ group compared with the @ +@ group with serotypes @ , @ , and @ specific IgG of at least @ g/mL ; the proportion of participants with PCV@ serotype-specific IgG of at least @ g/mL and opsonophagocytic activity reciprocal titre of at least @ at ages @ weeks and @ months ; and nasopharyngeal pneumococcal serotype-specific carriage rates at age @ months in each study group .


In the follow-up study , the primary outcome measure was the proportion of participants with IgG of at least @ g/mL for PCV@ serotypes at age @-@ years in children previously immunised with a @ +@ schedule compared with a @ +@ schedule .


The trial is registered with Current Controlled Trials , registration number ISRCTN@ .


Between May @ , @ , and Jan @ , @ , @ children were randomly assigned to each group : @ to the @ +@ group , @ to the @ +@ group , and @ to the @ +@ group .


At age @ months , the proportions of @ +@ participants with IgG of at least @ g/mL were @ % ( @ % CI @-@ ) for serotype @ , @ % ( @-@ ) for serotype @ , and @ % ( @-@ ) for serotype @ .


At age @ weeks , non-inferiority ( within @ % levels ) of the @ +@ group was shown compared with the @ +@ group , and there was no difference between the @ +@ and @ +@ groups for the proportion with IgG of at least @ g/mL for any of the PCV@ serotypes .


At age @ months , proportions with IgG of at least @ g/mL for serotypes @ , @ , @B , and @F , were higher in the @ +@ group than in the @ +@ group .


At age @ weeks , there were no differences in opsonophagocytic activity between the @ +@ and @ +@ groups for reciprocal titres of at least @ , but at age @ months , proportions with an opsonophagocytic reciprocal titre of at least @ for serotypes @ , @ , @ , @B , @C , @F and @F were higher in the @ +@ group than in the @ +@ group .


At age @-@ years , there were higher proportions in the @ +@ group versus the @ +@ group with IgG of at least @ g/mL for serotypes @ , @ , @B , and @C .


Use of a @ +@ PCV schedule with booster at age @ months in a resource-poor setting improved antibody persistence through early childhood without compromising antibody responses in early infancy .


This schedule is now recommended by WHO for progressive introduction across Nepal , with PCV@ introduction having commenced on Jan @ , @ .


Concurrent pre-implementation and post-implementation surveillance is being done by a GAVI Alliance funded study .


To determine the safety and efficacy of intraoperative cell salvage system in decreasing the need for allogeneic transfusions in a cohort of scoliosis patients undergoing primary posterior spinal fusion with segmental spinal instrumentation .


A total of @ consecutive scoliosis patients undergoing posterior instrumented spinal fusion were randomized into two groups according to whether a cell saver machine for intraoperative blood salvage was used or not .


Data included age , body mass index , perioperative hemoglobin levels , surgical time , levels fused , perioperative estimated blood loss , perioperative transfusions and incidence of transfusion-related complications .


A Chi-square test and t tests were performed for intraoperative and perioperative allogeneic transfusion between groups .


A regression analysis was performed between selected covariates to investigate the predictive factors of perioperative transfusion .


Perioperative allogenic blood transfusion rate was lower in the cell saver group ( @ versus @ % , p = @ ) .


Mean intraoperative red blood cell transfusion requirement was also lower ( @ U/pt versus @ U/pt , p = @ ) .


A multivariate analysis demonstrated that no .


of fused segments ( OR : @ ; p = @ ) , preoperative hemoglobin level ( OR : @ ; p = @ ) , and the use of cell saver system ( OR : @ ; p = @ ) had a trend toward significance in predicting likelihood of transfusion .


Cell saver use significantly reduces the need for allogeneic blood in spine deformity surgery , particularly in patients with low preoperative hemoglobin or longer operation time .


This study confirms the utility of routine cell saver use during PSF with segmental spinal instrumentation for scoliosis patients .


To compare the incidence and intensity of posterior capsular opacification ( PCO ) and neodymium : yttrium-aluminium-garnet ( Nd : YAG ) capsulotomy rates between two microincision intra-ocular lenses ( IOLs ) @ years after surgery .


Sixty-five patients randomly received a Y-@H IOL ( HOYA Surgical Optics , Singapore ) in one eye and a Micro AY IOL ( PhysIOL , Lige , Belgium ) in the contralateral eye during same-day bilateral cataract surgery .


Eyes were examined @ week , @ months and @ years after surgery .


The amount of PCO ( score : @-@ ) was assessed subjectively at the slit lamp and objectively using automated image analysis software ( aqua ) .


Additionally , the Nd : YAG capsulotomy rate was noted .


Three years postoperatively , the objective PCO score of Y-@H IOLs was @ @ compared to PCO score of @ @ for the Micro AY IOLs ( p = @ ) .


Thirty-four percentage of the Y-@H eyes had undergone Nd : YAG capsulotomy , compared to @ % of the Micro AY eyes ( p = @ ) .


Significantly , more capsular folds were observed in the Y-@H IOL group ( p = @ ) .


There was no significant difference in best-corrected visual acuity , rhexis/IOL overlap and anterior capsule opacification @ years after surgery .


Both microincision IOLs showed high YAG rates and comparable PCO scores @ years after surgery .


In the light of this unsatisfying PCO performance , the advantage of the present microincision IOLs over conventional IOLs must be questioned .


Medications are an effective intervention for managing and preventing health problems but their benefit can be undermined by non-adherence or adverse drug events ( ADEs ) .


Since these issues may be interconnected , efforts to improve non-adherence should also include reduction of ADEs .


We have developed the ISTOP-ADE system ( Information Systems-enabled Outreach for Preventing Adverse Drug Events ) , which enables timely monitoring and managing of ADEs .


The objectives of this study are to determine whether the ISTOP-ADE system , compared to routine care , will reduce : a ) the probability of discontinuing the use of prognosis-altering medications ; b ) the probability of a patient experiencing a severe ADE ; c ) the proportion of patients experiencing ADEs , preventable ADEs and ameliorable ADEs ; and d ) health services utilization .


We will randomly assign @,@ adult ambulatory patients in the province of Qubec who have been prescribed an incident medication for the management or prevention of a chronic health condition , to routine care or the ISTOP-ADE system .


The ISTOP-ADE system consists of an interactive voice response system ( IVRS ) paired with pharmacist support .


The IVRS will call patients at @ and @days post-prescription to determine if they are experiencing any problems and connect them with a pharmacist when required or desired by the patient .


We will evaluate medication persistence at @days and health-care utilization using provincial administrative data .


Two blinded physicians will ascertain ADE status through a case review .


We expect the ISTOP-ADE intervention to be feasible and to improve the quality of patient care through improved medication adherence , reduced ADE duration and reduced number of ADEs resulting in an emergency department or inpatient encounter .


This in turn could lower health-care utilization , saving costs and lowering the burden on emergency departments and family practices .


The success of ISTOP-ADE would present opportunities to implement this intervention through health systems , health insurance agents and commercial pharmacies .


Entering primary school is an important childhood milestone , marking the beginning of a child 's formal education .


Yet the change creates a time of vulnerability for the child , the parents and the parent-child relationship .


Failure to adjust to the transition may place the family in a psychologically devastating position .


The aims of this study were to test the effectiveness of a parental training programme in enhancing the parent-child relationship and decreasing parental stress by reducing harsh parenting in preparing children for the transition to primary school .


A randomised controlled trial incorporating a two-group pre-test and repeated post-test was conducted in one of the largest public housing estates in Hong Kong .


A total of @ parents were recruited , with @ parents randomly assigned to the experimental group and @ to the control group .


Harsh parenting practices , parent-child relationships and parental stress were assessed .


In comparison to parents in the control group , those in the experimental group engaged in less harsh parenting practices and reported better parent-child relationships .


However , parental stress scores did not differ significantly between the two groups .


This study addressed a gap in the literature by examining the effectiveness of the training programme for enhancing parent-child relationship and decreasing parental stress at the time of a child 's transition to primary school .


The findings from this study provide empirical evidence of the effectiveness of the parental training programme and highlight the significance of parenting in promoting a smooth transition for children from kindergarten to primary @ .


Postpartum depression ( PPD ) and poor childbirth outcomes are associated with poverty ; these variables should be addressed by an adapted approach .


The aim of this research was to evaluate the impact of an antenatal programme based on a novel psychosomatic approach to pregnancy and delivery , regarding the risk of PPD and childbirth outcomes in disadvantaged women .


A multi-centre , randomized , controlled trial comparing a novel to standard antenatal programme .


Primary outcome was depressive symptoms ( using EPDS ) and secondary outcome was preterm childbirth ( fewer @ weeks ) .


The sample comprised @ couples in which the women were identified to be at PPD risk by validated interview .


The study was conducted in three public hospitals with comparable standards of perinatal care .


Women were randomly distributed in to an experimental group ( EG ) or a control group ( CG ) , and evaluated twice : during pregnancy ( T@ ) and four weeks post-partum ( T@ ) .


At T@ , the variables were compared using the chi square test .


Data analysis was based on intention to treat .


The novel programme used the Tourn psychosomatic approach focusing on body awareness sensations , construction of an individualized childbirth model , and attachment .


The @ group antenatal sessions each lasted two hours , with one telephone conversation between sessions .


In the control group , the participants choose the standard model of antenatal education , i.e. , @ to @ two-hour sessions focused on childbirth by obstetrical prophylaxis .


A difference of @ % was noted in postpartum percentages of PPD risk ( EPDS @ ) : @ % ( @ ) in EG and @ % ( @ ) in CG ( p = @ ) .


The number of depressive symptoms among EG women decreased at T@ ( intragroup p = @ ) .


Premature childbirth was four times less in EG women : three ( @ % ) compared to @ ( @ % ) among CG women ( p = @ ) .


Birth weight was higher in EG women ( p = @ ) .


The decrease of depressive symptoms in women was not conclusive .


However , because birth weight was higher and the rate of preterm childbirth was lower in the EG , our results suggest that the psychosomatic approach may be more helpful to the target population than the standard antenatal programs .


To evaluate the effects of canrenone compared to placebo on blood pressure control , some non-conventional biomarkers in cardiovascular stratification , and on metalloproteinases in patients affected by metabolic syndrome .


A total of @ Caucasian patients were treated with placebo or canrenone , @ mg once a day , for @ months and then @ mg twice a day , till the end of the study .


We evaluated : systolic ( SBP ) and diastolic blood pressure ( DBP ) , body weight , body mass index ( BMI ) , fasting plasma glucose ( FPG ) , lipid profile , plasma aldosterone , creatinine , potassium , brain natriuretic peptide ( BNP ) , metalloproteinases @ and @ ( MMP-@ and -@ ) , lipoprotein ( a ) ( Lp ( a ) ) , and serum myeloperoxidase ( MPO ) .


We observed a significant decrease of SBP and DBP in the canrenone group compared to baseline .


Canrenone gave a significant decrease of MMP-@ and -@ , Lp ( a ) , and MPO compared to baseline , not observed with placebo .


Plasma aldosterone , but not BNP , decreased with canrenone , both compared to baseline and to placebo .


Canrenone seems to be effective in reducing blood pressure in patients with metabolic syndrome .


Moreover , canrenone seems also to improve MPO , Lp ( a ) , and metalloproteinases in these patients .


Health promotion at the work site in terms of physical activity has proven positive effects but optimization of relevant exercise training protocols and implementation for high adherence are still scanty .


The aim of this paper is to present a study protocol with a conceptual model for planning the optimal individually tailored physical exercise training for each worker based on individual health check , existing guidelines and state of the art sports science training recommendations in the broad categories of cardiorespiratory fitness , muscle strength in specific body parts , and functional training including balance training .


The hypotheses of this research are that individually tailored worksite-based intelligent physical exercise training , IPET , among workers with inactive job categories will : @ ) Improve cardiorespiratory fitness and/or individual health risk indicators , @ ) Improve muscle strength and decrease musculoskeletal disorders , @ ) Succeed in regular adherence to worksite and leisure physical activity training , and @ ) Reduce sickness absence and productivity losses ( presenteeism ) in office workers .


The present RCT study enrolled almost @ employees with sedentary jobs in the private as well as public sectors .


The training interventions last @ years with measures at baseline as well as one and two years follow-up .


If proven effective , the intelligent physical exercise training scheduled as well as the information for its practical implementation can provide meaningful scientifically based information for public health policy .


This phase I study assessed the pharmacokinetic ( PK ) , tolerability , safety and preliminary clinical activity of tamoxifen ( T ) and lapatinib ( L ) in patients with metastatic breast cancer ( MBC ) .


Patients ( pts ) with hormone receptor positive MBC , irrespective of HER-@ status , were randomly assigned to T T + L group , tamoxifen in cycle @ for @ days then adding lapatinib on day @ of cycle @ ; or L T + L group , lapatinib in cycle @ for @ days , then adding tamoxifen on day @ of cycle @ to evaluate the potential drug-drug PK interaction at steady-state .


The dose of tamoxifen was @ mg/day and lapatinib @ mg/day .


Twenty-five pts were enrolled of which @ started treatment , five ( @ % ) of them were HER-@ positive .


Median age was @ years and @ % had PS @ .


Eleven ( @ % ) pts in the T T + L group and @ ( @ % ) in L T + L group received at least @ cycles of treatment .


The most frequently reported drug-related adverse events ( > @ % of patients ) were diarrhoea ( @ % ) , anaemia ( @ % ) , rash ( @ % ) , fatigue ( @ % ) , dermatology other ( @ % ) and leukopenia ( @ % ) .


Grade @-@ drug-related toxicities were infrequent ( < @ % ) .


No cardiotoxicity was observed .


T plasma concentrations did not appeared to be affected by the presence of lapatinib .


L steady-state plasma concentrations were @ % lower after @ days of co-administration with T. Eight ( @ % ) patients experienced stable disease and median progression free survival was @ months .


The combination of L and T was safe and clinically active .


T affected L plasma concentrations , which remained within the therapeutic index .


Repeated-measures , crossover , double-blinded randomized controlled trial .


To compare the immediate effectiveness of @ types of counterforce braces in improving pain-free grip strength , pressure pain threshold , and wrist angle during a gripping task in individuals with lateral epicondylalgia .


Sports medicine management of lateral epicondylalgia often includes application of a counterforce brace , but the comparative effectiveness of different braces is unclear .


The most common brace design consists of a single strap wrapped around the proximal forearm .


A variation of this brace is the use of an additional strap that wraps above the elbow , which aims to provide further unloading to the injured tissue .


Pain-free grip strength , pressure pain threshold , and wrist angle during a gripping task were measured on @ participants with a clinical diagnosis of lateral epicondylalgia ( mean SD age , @ @ years ) .


Measurements were made without a brace , as well as immediately before and after the application of @ types of counterforce braces .


Each condition was tested during a separate session , with a minimum of @ hours between sessions .


Analysis-of-variance models were used to test the differences within and between conditions .


Pain-free grip strength ( @ N ; @ % confidence interval : @ , @ ) and pressure pain threshold ( @ kPa ; @ % confidence interval : @ , @ ) significantly improved on the affected side immediately following the intervention conditions as well as the control condition .


There was no significant difference between braces or the control condition for any outcome .


Both types of counterforce braces had an immediate positive effect in participants with lateral epicondylalgia , without differences between interventions and similar to a no-brace control condition .


Therefore , while the use of a brace may be helpful in managing immediate symptoms related to lateral epicondylalgia , the choice of which brace to use may be more a function of patient preference , comfort , and cost .


Further research is required to investigate the comparative longer-term and clinical effects of the @ braces .


The issue of osteoporosis-induced fractures has attracted the world 's attention .


Postmenopausal women are particularly at risk for this type of fracture .


The nonmedicinal intervention for postmenopausal women is mainly exercise .


Whole body vibration ( WBV ) is a simple and convenient exercise .


There have been some studies investigating the effect of WBV on osteoporosis ; however , the intervention models and results are different .


This study mainly investigated the effect of high-frequency and high-magnitude WBV on the bone mineral density ( BMD ) of the lumbar spine in postmenopausal women .


This study randomized @ postmenopausal women into either the WBV group or the control group for a @-month trial .


The WBV group received an intervention of high-frequency ( @ Hz ) and high-magnitude ( @ g ) WBV in a natural full-standing posture for @ minutes , three times per week , at a sports center .


Dual-energy X-ray absorptiometry was used to measure the lumbar BMD of the two groups before and after the intervention .


Six months later , the BMD of the WBV group had significantly increased by @ % ( P = @ ) , while that of the control group had decreased by @ % ( P = @ ) .


The comparison between the two groups showed that the BMD of the WBV group had increased significantly ( P = @ ) .


This study found that @ months of high-frequency and high-magnitude WBV yielded significant benefits to the BMD of the lumbar spine in postmenopausal women , and could therefore be provided as an alternative exercise .


To explore correlation between lung and large intestine and the two meridians under pathological condition in the view of meridian theory .


Ninety-six cases of bronchial asthma were applied palpation at the running course of @ regular meridians under the elbow and knees and back-shu points .


And abnormal reactions were recorded , the affected meridians and back-shu points were discovered .


The abnormal reactions most frequently appeared on the Lung Meridian , followed by the Large Intestine Meridian , the Spleen Meridian , the Liver Meridian , the Stomach Meridian and the Triple Energizer Meridian .


And the unusual reaction of the back-shu points most frequently appeared on Feishu ( BL @ ) , and Dachangshu ( BL @ ) and Pishu ( BL @ ) followed as the next two .


The existence of correlation between the Lung Meridian and the Large Intestine Meridians under pathological condition can be proved through meridian and acupoint palpation on bronchial asthma patients .


Catheter ablation of atrial fibrillation ( AF ) is a physically demanding procedure for the operator , involving radiation exposure , and has limited success rates .


Remote robotic navigation ( RRN ) may offer benefit to the procedure , though only @ previous small randomized trial has assessed this .


This study aimed to investigate the impact of RRN on @-year single-procedure success rates .


RRN was compared to manual ablation in a randomized control trial setting by using an intention-to-treat analysis .


A total of @ patients underwent ablation ( @/@ ( @ % ) persistent AF ; @/@ ( @ % ) of these long-standing persistent AF ) .


There were no significant differences between the RRN and manual groups with respect to @-year single-procedure success rates ( @/@ ( @ % ) and @/@ ( @ % ) , respectively ; P = @ ) , acute wide area circumferential ablation reconnection rates , complication rates , or procedure times .


On multivariable analysis , fluoroscopy times were significantly shorter in the RRN group .


The number of catheter displacements during ablation was lower in the RRN group , as was subjectively assessed operator fatigue .


The crossover rate from RRN to manual ablation was @/@ ( @ % ) , mainly secondary to technical problems with the RRN system .


A learning curve was evident for RRN ablation : the fluoroscopy and procedure times were significantly lower after the first @ cases in an operator 's experience .


This randomized trial showed no difference in the success rate for catheter ablation of AF between a RRN and manual approach .


The results highlight the learning curve for RRN ablation and suggest that the use of this technology leads to an improvement in fluoroscopy times , catheter stability , and operator fatigue .


We aimed to examine the association between daily protein intake ( DPI ) and outcomes in patients from the Randomized Evaluation of Normal versus Augmented Level ( RENAL ) trial .


We analyzed the association between DPI and clinical outcomes using multivariable logistic regression , Cox proportional hazards models and time-adjusted analysis .


During ICU stay , mean DPI was @ g/day among survivors and @ g/day among nonsurvivors ( p = @ ; DPI of @ g/kg/day ) .


Only @ ( @ % ) of the patients received a mean DPI of > @ g/kg .


Patients with a DPI above the median had a @ % mortality compared with @ % for a DPI below the median ( p = @ ) .


On multivariate analysis , a lower DPI was not associated with increased odds ratios for @-day mortality or any secondary outcomes .


Cox proportional hazards models and time-adjusted analysis confirmed these findings .


In the RENAL study , mean DPI was low .


Within the confines of such low DPI , greater amounts of DPI were not independently associated with improved clinical outcomes .


Video Journal Club `` Cappuccino with Claudio Ronco '' at www.karger.com/?doi=@ .


The implantable cardioverter defibrillator ( ICD ) is better than antiarrhythmic drug therapy for the primary and secondary prevention of all-cause mortality and sudden cardiac death in patients with either coronary artery disease or idiopathic dilated cardiomyopathy .


This study aims to assess whether the ICD also has this effect for primary prevention in chronic Chagas cardiomyopathy ( CCC ) .


In this randomized ( concealed allocation ) open-label trial , we aim to enroll up to @,@ patients with CCC , a Rassi risk score for death prediction of @ points , and at least @ episode of nonsustained ventricular tachycardia on a @-hour Holter monitoring .


Patients from @ centers in Brazil will be randomly assigned in a @:@ ratio to receive an ICD or amiodarone ( @ mg/d for @ days , then @-@ mg/d until the end of the study ) .


The randomization sequence will be generated by computer , and the members of the committees responsible for end point validation and data analysis will be blinded to study assignment .


The primary end point is all-cause death , and enrolment will continue until @ patients have reached this end point .


Key secondary end points include cardiovascular death , sudden cardiac death , hospitalization for heart failure , and quality of life .


We expect follow-up to last @ to @ years , and data analysis will be done on an intention-to-treat basis .


This trial is registered with ClinicalTrials.gov number NCT@ .


CHAGASICS is the first large-scale trial to assess the benefit of ICD therapy for the primary prevention of death in patients with CCC and nonsustained ventricular tachycardia , who have a moderate to high risk of death .


The efficacy , acceptability and tolerability of the new oral phosphate binder Lenziaren ( SBR@ ) were evaluated in a randomized parallel-group design study in @ healthy cats ( n = @ per group ) .


Five groups were fed once daily with a commercial diet containing @ % phosphorus ( `` standard diet '' ) into which was mixed Lenziaren at @ , @ , @ or @ g/day or no treatment ( control group ) daily for @ days .


A sixth group was fed a commercial diet containing lower amounts ( @ % ) of phosphorus ( `` renal diet '' ) and no treatment .


When compared to the control group , Lenziaren produced significant dose-related reductions in urine phosphate concentrations , urine phosphate excretion and fractional urinary phosphate excretion .


Significant effects versus the control group were observed at the @ , @ and @ g/day dosages .


Lenziaren was well tolerated and was associated with higher food consumption and serum iron concentrations versus the control .


When compared to the control group , the renal diet was associated with significantly lower urine phosphate concentrations and loss of body weight .


Lenziaren had similar effects on urine phosphate concentrations compared to the renal diet , but was not associated with loss of body weight .


Lenziaren was effective as an oral phosphate binder in cats fed with a standard diet containing @ % phosphorus .


The acceptability and tolerability were good .


Dosages of @-@ @ g/cat per day are recommended for clinical testing in cats fed with a standard diet .


The present study evaluated three technology-based methods of training mental health providers in exposure therapy ( ET ) for anxiety disorders .


Training methods were designed to address common barriers to the dissemination of ET , including limited access to training , negative clinician attitudes toward ET , and lack of support during and following training .


Clinicians nave to ET ( N = @ , Mage = @ , @ % female , @ % Caucasian ) were randomly assigned to ( a ) an interactive , multimedia online training ( OLT ) , ( b ) OLT plus a brief , computerized motivational enhancement intervention ( OLT+ME ) , or ( c ) OLT+ME plus a Web-based learning community ( OLT+ME+LC ) .


Assessments were completed at baseline , posttraining , and @ and @weeks following training .


Outcomes include satisfaction , knowledge , self-efficacy , attitudes , self-reported clinical use , and observer-rated clinical proficiency .


All three training methods led to large and comparable improvements in self-efficacy and clinical use of ET , indicating that OLT alone was sufficient for improving these outcomes .


The addition of the ME intervention did not significantly improve outcomes in comparison to OLT alone .


Supplementing the OLT with both the ME intervention and the LC significantly improved attitudes and clinical proficiency in comparison to OLT alone .


The OLT+ME+LC condition was superior to both other conditions in increasing knowledge of ET .


Multicomponent trainings that address multiple potential barriers to dissemination appear to be most effective in improving clinician outcomes .


Technology-based training methods offer a satisfactory , effective , and scalable way to train mental health providers in evidence-based treatments such as ET .


We compared intestinal , hepatic , and other organ function after hepatic portal occlusion with or without dexmedetomidine administration under general anaesthesia .


In this prospective , randomized double-blind investigation , @ patients undergoing elective hepatectomy with inflow occlusion were randomized into a dexmedetomidine group or a control group .


The dexmedetomidine group received an initial dexmedetomidine loading dose of @ g kg ( -@ ) over @ min followed by a maintenance dose of @ g kg ( -@ ) h ( -@ ) .


In the control group , @ % sodium chloride was administered .


The primary outcome was serum diamine oxidase ( DAO ) activity reflecting intestinal injury .


The secondary outcomes included variables reflecting intestinal , hepatic , kidney , and cardiopulmonary function , and biomarkers of oxidative stress and systemic inflammatory response .


DAO activity was lower in the dexmedetomidine group than in the control group at @ and @ h after liver reperfusion -LSB- @ ( @ ) vs@ @ ( @ ) units ml ( -@ ) , P = @ ; @ ( @ ) vs @ ( @ ) units ml ( -@ ) , P = @ -RSB- .


d-lactate acid levels were lower during @-@ h after liver reperfusion compared with the control group ( all P < @ ) .


Also , the intestinal injury severity grade was decreased by dexmedetomidine ( P = @ ) .


The biomarkers reflecting liver injury increased over time , but were lower in the dexmedetomidine group ( all P < @ ) , while the variables reflecting cardiopulmonary and renal function showed no differences between the groups ( all P > @ ) .


Dexmedetomidine administered perioperatively attenuates intestinal and hepatic injury in patients undergoing elective liver resection with inflow occlusion without any potential risk .


Nonsteroidal anti-inflammatory drugs are efficacious for the treatment of acute and chronic pain ; however , they have the potential for serious adverse events ( AEs ) .


The objective of this study was to evaluate the efficacy and safety of investigational , lower-dose , indomethacin submicron particle capsules compared with placebo in a study of patients with postsurgical pain .


This phase @ , multicenter , randomized , double-blind , single-dose , and placebo-controlled study enrolled @ patients ( @ to @ y old ) following extraction of @ third molars who experienced moderate-to-severe pain intensity @ hours after surgery .


Patients received indomethacin submicron particle capsules ( @ or @ mg ) , celecoxib @ mg , or placebo .


The primary efficacy endpoint was the sum of total pain relief over @ to @ hours ( TOTPAR-@ ) determined from the area under the curve for pain relief over @ to @ hours following administration of the study drug , where pain relief was measured on a @ to @ scale .


Safety and tolerability were also assessed .


Mean SE TOTPAR-@ scores were @ @ ( indomethacin submicron particle capsules @ mg ) , @ @ ( indomethacin submicron particle capsules @ mg ) , @ @ ( celecoxib ) , and @ @ ( placebo ; P < @ for active treatments vs. placebo ) .


Indomethacin submicron particle capsules treatment groups demonstrated better mean TOTPAR over @ hours than placebo ( P < @ ) .


Similar rates and profiles of treatment-emergent AEs were reported by patients across treatment groups .


Lower-dose , indomethacin submicron particle capsules provide good overall pain relief in patients with postsurgical pain and are generally well tolerated .


Indomethacin submicron particle capsules are a potentially promising option for treatment of acute pain and warrant further study .


National Surgical Adjuvant Breast and Bowel Project ( NSABP ) trial B-@ suggested the efficacy of adjuvant trastuzumab , even in HER@-negative breast cancer .


This finding prompted us to develop a predictive model for degree of benefit from trastuzumab using archived tumor blocks from B-@ .


Case subjects with tumor blocks were randomly divided into discovery ( n = @ ) and confirmation cohorts ( n = @ ) .


A predictive model was built from the discovery cohort through gene expression profiling of @ genes with nCounter assay .


A predefined cut point for the predictive model was tested in the confirmation cohort .


Gene-by-treatment interaction was tested with Cox models , and correlations between variables were assessed with Spearman correlation .


Principal component analysis was performed on the final set of selected genes .


All statistical tests were two-sided .


Eight predictive genes associated with HER@ ( ERBB@ , c@orf@ , GRB@ ) or ER ( ESR@ , NAT@ , GATA@ , CA@ , IGF@R ) were selected for model building .


Three-dimensional subset treatment effect pattern plot using two principal components of these genes was used to identify a subset with no benefit from trastuzumab , characterized by intermediate-level ERBB@ and high-level ESR@ mRNA expression .


In the confirmation set , the predefined cut points for this model classified patients into three subsets with differential benefit from trastuzumab with hazard ratios of @ ( @ % confidence interval -LSB- CI -RSB- = @ to @ ; P = @ ; n = @ ) , @ ( @ % CI = @ to @ ; P = @ ; n = @ ) , and @ ( @ % CI = @ to @ ; P < @ ; n = @ ; P ( interaction ) between the model and trastuzumab < @ ) .


We developed a gene expression-based predictive model for degree of benefit from trastuzumab and demonstrated that HER@-negative tumors belong to the moderate benefit group , thus providing justification for testing trastuzumab in HER@-negative patients ( NSABP B-@ ) .


To assess the neuropsychological outcome @ months after bilateral deep brain stimulation ( DBS ) of the globus pallidus pars interna ( GPi ) or subthalamic nucleus ( STN ) for advanced Parkinson disease .


We randomly assigned patients to receive either GPi DBS or STN DBS .


Standardized neuropsychological tests were performed at baseline and after @ months .


Patients and study assessors were masked to treatment allocation .


Univariate analysis of change scores indicated group differences on Stroop word reading and Stroop color naming ( confidence interval -LSB- CI -RSB- @-@ @ and @-@ @ ) , on Trail Making Test B ( CI @-@ @ ) , and on Wechsler Adult Intelligence Scale similarities ( CI -@ to @ ) , with STN DBS showing greater negative change than GPi DBS .


No differences were found between GPi DBS and STN DBS on the other neuropsychological tests .


Older age and better semantic fluency at baseline predicted cognitive decline after DBS .


We found no clinically significant differences in neuropsychological outcome between GPi DBS and STN DBS .


No satisfactory explanation is available for the predictive value of baseline semantic fluency for cognitive decline .


This study provides Class I evidence that there is no large difference in neuropsychological outcome between GPi DBS and STN DBS after @ months .


The study lacks the precision to exclude a moderate difference in outcomes .


There are relatively few studies in the literature that specifically evaluate accelerated rehabilitation protocols for distal radial fractures treated with open reduction and internal fixation ( ORIF ) .


The purpose of this study was to compare the early postoperative outcomes ( at zero to twelve weeks postoperatively ) of patients enrolled in an accelerated rehabilitation protocol with those of patients enrolled in a standard rehabilitation protocol following ORIF for a distal radial fracture .


We hypothesized that patients with accelerated rehabilitation after volar ORIF for a distal radial fracture would have an earlier return to function compared with patients who followed a standard protocol .


From November @ to November @ , eighty-one patients with an unstable distal radial fracture were prospectively randomized to follow either an accelerated or a standard rehabilitation protocol after undergoing ORIF with a volar plate for a distal radial fracture .


Both groups began with gentle active range of motion at three to five days postoperatively .


At two weeks , the accelerated group initiated wrist/forearm passive range of motion and strengthening exercises , whereas the standard group initiated passive range of motion and strengthening at six weeks postoperatively .


Patients were assessed at three to five days , two weeks , three weeks , four weeks , six weeks , eight weeks , twelve weeks , and six months postoperatively .


Outcomes included Disabilities of the Arm , Shoulder and Hand ( DASH ) scores ( primary outcome ) and measurements of wrist flexion/extension , supination , pronation , grip strength , and palmar pinch .


The patients in the accelerated group had better mobility , strength , and DASH scores at the early postoperative time points ( zero to eight weeks postoperatively ) compared with the patients in the standard rehabilitation group .


The difference between the groups was both clinically relevant and statistically significant .


Patients who follow an accelerated rehabilitation protocol that emphasizes motion immediately postoperatively and initiates strengthening at two weeks after volar ORIF of a distal radial fracture have an earlier return to function than patients who follow a more standard rehabilitation protocol .


Therapeutic Level I. See Instructions for Authors for a complete description of levels of evidence .


To compare the effects of administering equal volumes of isotonic crystalloids and synthetic colloids on hemodynamic and laboratory variables in healthy dogs and dogs with systemic inflammation .


Randomized , placebo-controlled , blinded study .


Comparative clinical research facility .


Sixteen adult purpose-bred Beagles .


Dogs were first randomized to receive either lipopolysaccharide ( LPS ; @ g/kg , IV ) or an equal volume of placebo ( @ % NaCl , IV ) .


Dogs were then randomized into @ of @ groups receiving fluid resuscitation with either @ mL/kg IV isotonic crystalloid ( @ % NaCl ) or synthetic colloid ( tetrastarch ) .


After a @-day washout , the study was repeated such that dogs received the opposite treatment ( LPS or placebo ) and the same resuscitation fluid regimen .


Vital signs ( heart rate ( HR ) , oscillometric blood pressure ) were measured and blood samples were collected for PCV , total plasma protein ( TPP ) , serum lactate concentration , and colloid osmotic pressure ( COP ) measurements .


Healthy ( placebo ) dogs had similar decreases in PCV and TPP after administration of either fluid .


Tetrastarch administration was associated with a larger increase in HR , systolic blood pressure , and mean blood pressure .


Dogs with systemic inflammation had similar increases in systolic blood pressure and decreases in PCV , TPP , and lactate after administration of either fluid .


Tetrastarch administration caused greater immediate increase in HR and mean blood pressure compared to @ % NaCl .


In all dogs , @ % NaCl administration decreased COP and tetrastarch administration increased COP .


Resuscitation with equal volumes of @ % NaCl and tetrastarch caused similar changes in hemodynamic and laboratory variables in dogs with LPS-induced systemic inflammation ; however , larger increases in HR and blood pressure were seen within the first @ hours following tetrastarch administration compared to @ % NaCl .


Tetrastarch administration increased COP in all dogs , despite a decrease in TPP .


Aortic valve replacement ( AVR ) in patients with a small aortic root is often associated with some degree of obstruction and residual gradients .


Stentless valves display better hemodynamic performance than stented valves , and might be ideal in patients with a small aortic annulus .


A new stented bioprosthesis , the Trifecta valve , has recently become available and has yielded interesting early results .


The study aim was to compare the hemodynamic performance of the Trifecta valve with that of the Freestyle valve in patients with an aortic annulus @ cm .


Between September @ and September @ , a total of @ patients with pure aortic stenosis and native aortic annulus diameter @ cm was randomized to receive either a St. Jude Medical Trifecta stented prosthesis ( n = @ ) or a Medtronic Freestyle stentless prosthesis ( n = @ ) .


Hemodynamics results were compared between the two groups on discharge from hospital .


The Trifecta valve showed slightly better hemodynamics , with peak gradients of @ @ mmHg and @ @ mmHg ( p = @ ) , and mean gradients of @ @ mmHg and @ @ mmHg ( p = @ ) for the Trifecta and Freestyle valves , respectively .


The average indexed effective orifice area ( EOAi ) was @ @ cm@/m@ and @ @ cm@/m@ ( p = @ ) for the Trifecta and Freestyle , respectively .


Patient-prosthesis mismatch ( PPM ) occurred in two patients of the Freestyle group , and in three patients of the Trifecta group .


In the present study , the stentless and stented prostheses each yielded comparable and excellent early hemodynamics results .


The data obtained suggest that Trifecta valve implantation is a valid means of avoiding PPM after AVR in patients with a small native aortic annulus .


To evaluate the efficacy and safety of once-daily oxybutynin patch therapy for overactive bladder .


A randomized double-blind trial was carried out in patients with overactive bladder syndrome , who received an oxybutynin patch , propiverine ( @ mg ) or placebo once daily for @ weeks .


The primary efficacy end-point was the change of the mean daily number of micturitions in week @ .


A total of @ patients were randomized to receive the oxybutynin patch ( @ ) , propiverine ( @ ) or placebo ( @ ) .


The change of the mean daily frequency of micturition from baseline in the full analysis set was -@ @ with the oxybutynin patch , which was significantly higher than with placebo ( -@ @ ) ( P = @ ) .


The difference of the mean change in the mean daily number of micturitions between the oxybutynin patch and propiverine groups showed a @ % confidence interval of -@ to @ , and the upper limit of this interval was below the predefined non-inferiority margin of @ , showing non-inferiority of the oxybutynin patch to propiverine .


The incidence of dry mouth and constipation was higher with propiverine than with the oxybutynin patch or placebo .


Application site dermatitis was more frequent with the oxybutynin patch ( @ % ) than with propiverine ( @ % ) or placebo ( @ % ) , but the dermatitis was generally mild .


This trial shows the efficacy of the new once-daily oxybutynin patch for overactive bladder .


Despite a higher rate of dermatitis with the oxybutynin patch , dry mouth and constipation occurs less often than during treatment with propiverine .


This study evaluated the effect of different types of activities during rest-break interventions on neck and shoulder muscle activity , muscle discomfort and productivity among symptomatic video display unit ( VDU ) operators performing prolonged computer terminal work .


Randomized controlled trial was used .


Thirty symptomatic VDU operators were randomly assigned to @ active break groups ( stretching and dynamic movement ) and a reference group .


The subjects performed the same typing task for @ min and received @-min breaks after each @ min of work .


Root mean square and median frequency were calculated for neck and shoulder muscle activity .


Muscle discomfort was measured with Borg 's CR-@ scale .


Productivity was measured by counting words .


There were no significant differences between the types of activities during breaks on neck and shoulder muscle activity , muscle discomfort or productivity .


However , there was a significant difference in the level of muscle discomfort over time .


Three types of activity during breaks showed a favourable effect on neck and shoulder muscle activity and productivity , and a positive effect on muscle discomfort in symptomatic VDU operators .


Physician-delivered tobacco treatment using the @As is clinically recommended , yet its use has been limited .


Lack of adequate training and confidence to provide tobacco treatment is cited as leading reasons for limited @A use .


Tobacco dependence treatment training while in medical school is recommended , but is minimally provided .


The MSQuit trial ( Medical Students helping patients Quit tobacco ) aims to determine if a multi-modal and theoretically-guided tobacco educational intervention will improve tobacco dependence treatment skills ( i.e. @As ) among medical students .


@ U.S. medical schools were pair-matched and randomized in a group-randomized controlled trial to evaluate whether a multi-modal educational ( MME ) intervention compared to traditional education ( TE ) will improve observed tobacco treatment skills .