The diagnosis of DVT can be difficult , especially when access to a specialist is limited , such as in case of rural patients .


The aim of the study .


The aim of the study was estimation of the influence of LMWH primary prophylaxis on the formation of postoperative DVT , as well as sensitivity and specificity of clinical examination and D-dimer value in diagnosis of postoperative DVT in women .


The study was conducted in a group of @ women operated on in the Department of General , Vascular Surgery and Angiology at the Karol Marcinkowski University of Medical Sciences in Pozna , Poland .


The patients had undergone a varicose vein operation and were randomly divided into two groups : A - @ women receiving LMWH during two days of the perioperative period , B - @ women receiving LMWH during seven days of the perioperative period .


There was no significant difference in the postoperative DVT complications in both groups .


The value of D-dimer > @ mcg/ml and swelling > @ cm of shin ( in comparison to the preoperative period ) plays a significant role in diagnosis of DVT .


The extended primary prophylaxis with LMWH does not affect the amount or quality of thrombotic complications after varicose vein operation .


If the DVT occurs , the evaluation of the D - dimer and careful clinical examination can be a useful method for its diagnosis .


Preliminary studies have shown that rituximab ( RTX ) is effective in the treatment of active Graves ' orbitopathy ( GO ) .


We conducted a double-blind , randomized trial ( European Clinical Trials Database -LSB- EudraCT -RSB- @-@-@ ) to compare RTX with iv methylprednisolone ( ivMP ) in patients with active moderate to severe GO .


Thirty-two patients were randomized to receive either ivMP ( @ g ) or RTX ( @ or @ mg ) .


The primary end point was the decrease of the clinical activity score of @ points or to less than @ at week @ .


Changes of proptosis , lid fissure , diplopia and eye muscle motility , and quality of life score were secondary end points .


The number of therapeutic responses , disease reactivation , and surgical procedures required during follow-up and the patients ' quality of life were also assessed .


The clinical activity score decreased with both treatments but more after RTX at @ , @ , and @ weeks ( P < @ , P < @ , P < @ , respectively ) , whether @ mg RTX twice or @ mg RTX once was used ( P = NS ) .


At @ weeks @ % of RTX patients improved compared with @ % after ivMP ( P < @ ) .


Disease reactivation was never observed in RTX patients but was observed in five after ivMP .


Patients treated with RTX scored better motility at @ weeks in both the right ( P = @ ) and the left eye ( P = @ ) .


Overall rehabilitative surgical procedures carried out during follow-up ( at @ wk ) were @ in @ ivMP patients and @ in @ RTX patients ( P = @ ) .


The results of this trial confirm preliminary reports on a better therapeutic outcome of RTX in active moderate to severe GO , when compared with ivMP , even after a lower RTX dose .


The better eye motility outcome , visual functioning of the quality of life assessment , and the reduced number of surgical procedures in patients after RTX seem to suggest a disease-modifying effect of the drug .


Web-based brief alcohol interventions are effective in reducing alcohol use among students when measured at limited follow-up time points .


To date , no studies have tested Web-based brief alcohol intervention effectiveness over time by using a large number of measurements .


Testing whether the What Do You Drink ( WDYD ) Web-based brief alcohol intervention can sustain a reduction in alcohol use among heavy-drinking students aged @-@ years at @ - , @ - , and @-month follow-up intervals .


A purely Web-based , @-arm , parallel-group randomized controlled trial applying an ecological momentary assessment approach with @ weekly measurements was conducted in the Netherlands ( @-@ ) .


Participants were recruited offline and online .


A total of @ participants were randomized into the experimental condition ( n = @ ) including the single-session and fully automated WDYD intervention , or into the control condition ( n = @ ) including assessment only .


Weekly alcohol consumption and frequency of binge drinking were the self-assessed outcome measures .


Attrition rates of the @ participants were @ ( @ % ) , @ ( @ % ) , and @ ( @ % ) at @ - , @ - , and @-month follow-up intervals , respectively .


Latent growth curve analyses according to the intention-to-treat principle revealed that participants in the experimental condition had significantly lower weekly alcohol consumption compared to participants in the control condition that was sustained at @-month follow-up ( intercept = -@ , P < @ ; slope = @ , P = @ ) .


Additional linear regression analyses indicated that this intercept difference resulted from significantly higher levels of alcohol units per week for participants in the control condition compared to those in the experimental condition at @-month ( beta = -@ , SE @ , Cohen 's d = @ , P = @ ) , @-month ( beta = -@ , SE @ , Cohen 's d = @ , P = @ ) , and @-month ( beta = -@ , SE @ , Cohen 's d = @ , P = @ ) follow-up intervals .


Latent growth curve analyses further indicated that participants in the experimental condition had a significantly lower frequency of binge drinking compared to participants in the control condition that was sustained at @-month follow-up ( intercept = -@ , P = @ ; slope = @ , P = @ ) .


This intercept difference resulted from higher levels in this outcome for participants in the control condition relative to participants in the experimental condition at @-month ( beta = -@ , SE @ , Cohen 's d = @ , P = @ ) , @-month ( beta = -@ , SE @ , Cohen 's d = @ , P = @ ) , and @-month ( beta = -@ , SE @ , Cohen 's d = @ , P = @ ) follow-up intervals .


The WDYD intervention was shown to be effective in preventing an increase in weekly alcohol consumption and frequency of binge drinking directly after the intervention .


This effect was sustained @ and @ months after the intervention .


To determine whether increased elimination of gadobenate ion via the hepatobiliary pathway might compensate for reduced/absent elimination via the urinary pathway in the event of compromised renal function , as a possible protective mechanism against nephrogenic systemic fibrosis ( NSF ) .


@ male Crl : CD ( ) R ( SD ) Br rats ( Charles River Italia , Como , Italy ) randomized to three treatment groups : ( @ ) animals with occluded bile ducts , ( @ ) animals with occluded renal vessels and ( @ ) control animals , each received @ mmol kg ( -@ ) of bodyweight of gadobenate dimeglumine ( MultiHance ( ) ; Bracco Imaging SpA , Milan , Italy ) .


Urine and bile were collected from @-@ , @-@ , @-@ , @-@ and @-@ min after gadobenate dimeglumine administration prior to exsanguination .


Determinations of gadobenate ion in blood , bile and urine were performed by high-performance liquid chromatography .


Gadolinium ( Gd ( @ + ) ) levels in excised liver and kidneys were determined by X-ray fluorescence .


The recovery of gadobenate ion in the urine of rats with bile duct occlusion was significantly higher than that in the urine of normal rats ( @ @ % vs @ @ % ; p < @ ) .


Conversely , mean recovery in the bile of rats with renal vessel occlusion was significantly higher than that in the bile of normal rats ( @ @ % vs @ @ % ; p < @ ) .


Gadobenate ion was not quantifiable in any group @ h post-injection .


Compensatory elimination may be an effective means to overcome compromised renal or hepatobiliary elimination .


The absence of NSF in at-risk patients administered with gadobenate dimeglumine may in part reflect greater Gd ( @ + ) elimination via the hepatobiliary route .


Oral propranolol has been used to treat complicated infantile hemangiomas , although data from randomized , controlled trials to inform its use are limited .


We performed a multicenter , randomized , double-blind , adaptive , phase @-@ trial assessing the efficacy and safety of a pediatric-specific oral propranolol solution in infants @ to @ months of age with proliferating infantile hemangioma requiring systemic therapy .


Infants were randomly assigned to receive placebo or one of four propranolol regimens ( @ or @ mg of propranolol base per kilogram of body weight per day for @ or @ months ) .


A preplanned interim analysis was conducted to identify the regimen to study for the final efficacy analysis .


The primary end point was success ( complete or nearly complete resolution of the target hemangioma ) or failure of trial treatment at week @ , as assessed by independent , centralized , blinded evaluations of standardized photographs .


Of @ infants who underwent randomization , @ received treatment .


On the basis of an interim analysis of the first @ patients who completed @ weeks of trial treatment , the regimen of @ mg of propranolol per kilogram per day for @ months was selected for the final efficacy analysis .


The frequency of successful treatment was higher with this regimen than with placebo ( @ % vs. @ % , P < @ ) .


A total of @ % of patients who received the selected propranolol regimen showed improvement by week @ , versus @ % of patients who received placebo .


A total of @ % of patients in whom treatment with propranolol was successful required systemic retreatment during follow-up .


Known adverse events associated with propranolol ( hypoglycemia , hypotension , bradycardia , and bronchospasm ) occurred infrequently , with no significant difference in frequency between the placebo group and the groups receiving propranolol .


This trial showed that propranolol was effective at a dose of @ mg per kilogram per day for @ months in the treatment of infantile hemangioma .


( Funded by Pierre Fabre Dermatologie ; ClinicalTrials.gov number , NCT@ . )


People with type @ diabetes ( T@DM ) require insulin therapy to sustain life , and need optimal glycaemic control to prevent diabetic ketoacidosis and serious long-term complications .


Insulin is generally administered using multiple daily injections but can also be delivered using an infusion pump ( continuous subcutaneous insulin infusion ) , a more costly option with benefits for some patients .


The UK National Institute for Health and Care Excellence ( NICE ) recommend the use of pumps for patients with the greatest need , citing insufficient evidence to approve extension to a wider population .


Far fewer UK adults use pumps than in comparable countries .


Previous trials of pump therapy have been small and of short duration and failed to control for training in insulin adjustment .


This paper describes the protocol for a large randomised controlled trial comparing pump therapy with multiple daily injections , where both groups are provided with high-quality structured education .


A multicentre , parallel group , cluster randomised controlled trial among @ adults with T@DM .


All participants attended the week-long dose adjustment for normal eating ( DAFNE ) structured education course , and receive either multiple daily injections or pump therapy for @years .


The trial incorporates a detailed mixed-methods psychosocial evaluation and cost-effectiveness analysis .


The primary outcome will be the change in glycosylated haemoglobin ( HbA@c ) at @months in those participants whose baseline HbA@c is at or above @ % ( @mmol/mol ) .


The key secondary outcome will be the proportion of participants reaching the NICE target of an HbA@c of @ % ( @mmol/mol ) or less at @months .


To optimize palliation in incurable locally advanced non-small cell lung cancer ( NSCLC ) , the International Atomic Energy Agency conducted a prospective randomized study ( NCT@ ) comparing protracted palliative radiotherapy ( RT ) course with chemotherapy ( CHT ) followed by short-course palliative RT. .


Treatment-naive patients with histologically confirmed NSCLC , stage IIIA/IIIB , received either @Gy in @ fractions as RT alone ( arm A , n = @ ) or @-@ platinum-based CHT cycles followed by @Gy in a single fraction or @Gy in @ fractions separated by one week ( arm B , n = @ ) .


Primary outcome was overall survival .


Treatment groups were balanced with respect to various variables .


Median survival for all @ patients was @months , while median survival was @ and @ months for the two arms , respectively ( log-rank p = @ by study arm , and p = @ by Cox regression and stratified by country and sub-stage ) .


One and three year survival rates for the two arms were @ % , and @ % and @ % , and @ % , respectively .


There were no differences in any of the following endpoints : any failure , local failure , regional failure , contralateral thoracic failure , and distant failure between the two arms .


High-grade ( @ ) toxicity was similar between the two arms .


Symptoms , adverse events of any kind , KPS and body-mass index , were not different during treatment and during follow-up .


There was no grade @ toxicity .


This incomplete and underpowered trial only hinted similar outcome between the treatment arms .


Therefore , combined CHT-RT can perhaps be considered , in limited resource setting , where access to RT remains inadequate .


Medical expulsive therapy ( MET ) using alpha-blockers is effective for distal ureteral calculi ( UC ) .


We aimed to evaluate the efficacy of tamsulosin for proximal UC expulsion .


An open-label randomized controlled trial was conducted with @ patients who agreed to conservative management for single , radiopaque , proximal UC @ mm and were randomized into group A ( n = @ , conservative managements only ) or B ( n = @ , @ mg tamsulosin once a day ) .


The primary end-point was stone passage rates ( SPR ) in the intention-to-treat population in @ treatment weeks .


The secondary end-points were estimated in per-protocol population and were time to stone passage , post-trial Euro-quality-of-life ( EuroQOL ) score , oral analgesic requirements , and willingness to undergo conservative treatment again .


The two groups were well balanced in terms of baseline patient and stone characteristics .


Seventy nine patients ( @ % ; @ of group A and @ of group B ) completed the study protocol .


The overall SPR was @ % ( @/@ ) .


Group B had a higher SPR ( @ % ; @/@ ) than group A ( @ % ; @/@ ; p = @ ) and a significantly shorter time to stone passage ( mean days , A : @ vs. B : @ , p = @ ) .


The groups did not differ in post-trial EuroQOL score or oral analgesic requirements , whereas @ % ( @/@ ) of group A and @ % ( @/@ ) of group B were willing to undergo conservative treatment again ( p = @ ) .


Univariate logistic regression analysis showed that stone size ( OR = @ , p = @ ) and tamsulosin treatment ( OR = @ , p = @ ) significantly predicted stone expulsion .


On multivariate analysis , only tamsulosin was statistically significant ( OR = @ , p = @ ) .


Tamsulosin was associated with significantly higher stone expulsion rate and shorter expulsion time in proximal UC @ mm compared with conservative managements only .


Our results indicate that similar to patients with distal UC , MET using tamsulosin is a reasonable treatment option for patients with proximal UC .


To address the public health crisis of overweight and obese preschool-age children , the Nutrition And Physical Activity Self Assessment for Child Care ( NAP SACC ) intervention was delivered by nurse child care health consultants with the objective of improving child care provider and parent nutrition and physical activity knowledge , center-level nutrition and physical activity policies and practices , and children 's body mass index ( BMI ) .


A seven-month randomized control trial was conducted in @ licensed child care centers serving predominantly low income families in California , Connecticut , and North Carolina , including @ child care providers and @ families with racially and ethnically diverse children three to five years old .


The NAP SACC intervention included educational workshops for child care providers and parents on nutrition and physical activity and consultation visits provided by trained nurse child care health consultants .


Demographic characteristics and pre - and post-workshop knowledge surveys were completed by providers and parents .


Blinded research assistants reviewed each center 's written health and safety policies , observed nutrition and physical activity practices , and measured randomly selected children 's nutritional intake , physical activity , and height and weight pre - and post-intervention .


Hierarchical linear models and multiple regression models assessed individual - and center-level changes in knowledge , policies , practices and age - and sex-specific standardized body mass index ( zBMI ) , controlling for state , parent education , and poverty level .


Results showed significant increases in providers ' and parents ' knowledge of nutrition and physical activity , center-level improvements in policies , and child-level changes in children 's zBMI based on @ children in the intervention and control centers at both pre - and post-intervention time points .


The NAP SACC intervention , as delivered by trained child health professionals such as child care health consultants , increases provider knowledge , improves center policies , and lowers BMI for children in child care centers .


More health professionals specifically trained in a nutrition and physical activity intervention in child care are needed to help reverse the obesity epidemic .


Chronic disease management presents enormous challenges to the primary care workforce because of the rising epidemic of cardiovascular risk factors .


The chronic care model was proven effective in improving chronic disease outcomes in developed countries , but there is little evidence of its effectiveness in developing countries .


The aim of this study was to evaluate the effectiveness of the EMPOWER-PAR intervention ( multifaceted chronic disease management strategies based on the chronic care model ) in improving outcomes for type @ diabetes mellitus and hypertension using readily available resources in the Malaysian public primary care setting .


This paper presents the study protocol .


A pragmatic cluster randomised controlled trial using participatory action research is underway in @ public primary care clinics in Selangor and Kuala Lumpur , Malaysia .


Five clinics were randomly selected to provide the EMPOWER-PAR intervention for @ year and another five clinics continued with usual care .


Each clinic consecutively recruits type @ diabetes mellitus and hypertension patients fulfilling the inclusion and exclusion criteria over a @-week period .


The EMPOWER-PAR intervention consists of creating/strengthening a multidisciplinary chronic disease management team , training the team to use the Global Cardiovascular Risks Self-Management Booklet to support patient care and reinforcing the use of relevant clinical practice guidelines for management and prescribing .


For type @ diabetes mellitus , the primary outcome is the change in the proportion of patients achieving HbA@c < @ % .


For hypertension without type @ diabetes mellitus , the primary outcome is the change in the proportion of patients achieving blood pressure < @/@ mmHg .


Secondary outcomes include the proportion of patients achieving targets for serum lipid profile , body mass index and waist circumference .


Other outcome measures include medication adherence levels , process of care and prescribing patterns .


Patients ' assessment of their chronic disease care and providers ' perceptions , attitudes and perceived barriers in care delivery and cost-effectiveness of the intervention are also evaluated .


Results from this study will provide objective evidence of the effectiveness and cost-effectiveness of a multifaceted intervention based on the chronic care model in resource-constrained public primary care settings .


The evidence should instigate crucial primary care system change in Malaysia .


This study compared the therapeutic effect of monotherapy with a nonsteroidal anti-inflammatory drug ( NSAID ) patch vs an NSAID patch combined with transcutaneous electric nerve stimulation ( TENS ) , a heating pad , or topical capsaicin in the treatment of patients with myofascial pain syndrome ( MPS ) of the upper trapezius .


A randomized , single-blind , controlled study of combination therapy for patients with MPS was performed .


Ninety-nine patients were randomly assigned to one of four different self-management methods for treatment : NSAID patch ( N = @ ) , NSAID patch + TENS ( N = @ ) , NSAID patch + heating pad ( N = @ ) , and NSAID patch + topical capsaicin ( N = @ ) .


The NSAID patch used in this study was a ketoprofen patch .


All treatment groups were observed for @ weeks , and the numeric rating scale ( NRS ) pain score , cervical active range of motion , pressure pain threshold , and Neck Disability Index were assessed .


There was no significant difference between the NSAID patch alone group and the three combination therapy groups with respect to decrease in NRS score from baseline ( day @ ) to each period of observation .


In covariate analysis , although there was no difference among the groups in most of the periods , the data at day @ indicated a trend ( P = @ ) .


There were no significant differences in the other variables .


We did not observe a statistical difference in improvements to the clinical variables among the four different methods .


However , further studies regarding the effectiveness of a mixture of topical capsaicin and ketoprofen in patients with MPS should be considered .


In view of freezing of gait 's circumstances of occurrence in Parkinson 's disease , attentional resources appear to be involved in step initiation failure .


Anticipatory postural adjustments ( APAs ) are essential because they allow unloading of the stepping leg and so create the conditions required for progression .


Our main objective was to establish whether or not a change in attentional load during step initiation modulates APAs differently in patients with vs. without freezing of gait .


Three groups of @ subjects were recruited : elderly people and parkinsonian patients with or without freezing of gait .


Attention was modulated before step execution by means of an auditory oddball discrimination task with event-related potential recording .


The primary endpoint was the occurrence of inappropriate APAs following the attentional task , i.e. APAs not followed by a step after an intercurrent auditory stimulus .


In parkinsonian patients with freezing of gait , inappropriate APAs were recorded in @ % of the trials and were observed more frequently than in patients without freezing of gait ( @ % ) and elderly controls ( @ % ) .


Furthermore , inappropriate APAs in freezers were longer and more ample than in parkinsonian non-freezers and controls .


Lastly , postural preparation was impaired in the parkinsonian patients .


Our results indicate that allocation of attentional resources during step preparation influences the release of APAs differently in freezers and non-freezers .


Modulating attentional load is partly responsible for triggering an inappropriate motor program .


This difficulty in focusing attention or resisting interference may contribute ( at least in part ) to the gait initiation failure observed in parkinsonian freezers .


To determine whether nonparetic arm force overinhibits the paretic arm in patients with chronic unilateral poststroke hemiparesis .


Case-control neurophysiological and behavioral study of patients with chronic stroke .


Research institution .


Eighty-six referred patients were screened to enroll @ participants ( N = @ ) with a > @ month history of @ unilateral ischemic infarct that resulted in arm hemiparesis with residual ability to produce @Nm of wrist flexion torque and without contraindication to transcranial magnetic stimulation .


Eight age - and handedness-matched healthy volunteers without neurologic diagnosis were studied for comparison .


Not applicable .


Change in interhemispheric inhibition targeting the ipsilesional primary motor cortex ( M@ ) during nonparetic arm force .


We hypothesized that interhemispheric inhibition would increase more in healthy controls than in patients with hemiparesis .


Healthy age-matched controls had significantly greater increases in inhibition from their active to resting M@ than patients with stroke from their active contralesional to resting ipsilesional M@ in the same scenario ( @ % @ % vs -@ % @ % , F@ ,@ = @ , P = @ ) .


Patients with greater increases in contralesional to ipsilesional inhibition were better performers on the @-hole peg test of paretic arm function .


Our findings reveal that producing force with the nonparetic arm does not necessarily overinhibit the paretic arm .


Though our study is limited in generalizability by the small sample size , we found that greater active contralesional to resting ipsilesional M@ inhibition was related with better recovery in this subset of patients with chronic poststroke .


For many patients , adhering to postmenopausal osteoporosis treatment is a challenge .


Higher treatment satisfaction is associated with greater persistence with these therapies , which is associated with better outcomes .


This study aimed to evaluate the change in treatment satisfaction in postmenopausal women who were suboptimally adherent to daily or weekly oral bisphosphonates and who transitioned to denosumab vs a monthly oral bisphosphonate .


Pooled data of outpatients from two international , multicenter , randomized , open-label studies were analyzed .


Postmenopausal women ( n = @ ) age @ years or greater with low bone mineral density who were suboptimally adherent with prior oral bisphosphonate therapy , as assessed by the Osteoporosis-Specific Morisky Medication Adherence Scale , were included in the study .


Patients received denosumab , a fully human monoclonal antibody to receptor activator of nuclear factor-kappa B ligand , @ mg s.c. every @ months vs the oral bisphosphonates ibandronate or risedronate , @ mg once monthly for @ months .


Change in treatment satisfaction scores from baseline to months @ and @ were measured using the Treatment Satisfaction Questionnaire for Medication ( TSQM ) .


The TSQM is a validated tool that measures perception of four domains of treatment satisfaction : effectiveness , side effects , convenience , and global satisfaction .


Patients in both treatment groups showed improvement from baseline for all four TSQM domains at @ and @ months .


However , the denosumab group had significantly ( all P < @ ) greater improvements among all four TSQM domains at @ and @ months compared with the oral bisphosphonate group .


Women with low adherence to oral bisphosphonates reported greater treatment satisfaction when transitioned to denosumab vs switching to a monthly oral bisphosphonate .


Mild hypoxia is common in stroke patients and may have significant adverse effects on the ischemic brain after stroke .


The use of oxygen treatment is rapidly increasing in European stroke units but is not without side effects .


It impedes early mobilization , could pose an infection risk , and may encourage the formation of toxic free radicals , leading to further damage to the ischemic brain .


In the Stroke Oxygen Pilot Study ( @ or @L/min for @hours ) neurological recovery at one week was better in the oxygen group than in controls , and after correction for difference in baseline stroke severity and prognostic factors , there was a trend to better outcome with oxygen at six months .


Oxygen was as effective in mild as in severe strokes.Oxygen saturation is lower at night than during the day , and episodes of oxygen desaturation are common during sleep .


Nocturnal oxygen supplementation is likely to reduce the burden of hypoxia without interfering with daytime mobilization and rehabilitation.Before wider use of oxygen supplementation becomes established it is important to obtain better evidence on which patients benefit from such treatment .


Participants will be randomized to one of three groups : the first will receive continuous oxygen for @hours ( at a rate of @ or @L/min depending on baseline oxygen saturation ) , the second group will receive nocturnal oxygen only ( at a rate of @ or @L/min depending on baseline oxygen saturation ) and the third group will not receive any oxygen ( control ) .


A baseline assessment is performed at randomization and a one-week follow-up completed .


Outcome data at three , six and twelve months will be obtained via a questionnaire sent to the patient by the trial center .


This study will provide evidence on the effectiveness of oxygen supplementation for the treatment of stroke and whether nocturnal oxygen is a potentially beneficial therapy regimen .


To investigate the blood pressure ( BP ) responses to cardiovascular stress test after a combined exercise circuit session at moderate intensity .


Twenty individuals ( @ male/@ fem ; @ @ years ; @ @ kg ; @ @ cm ; @ @ % body fat ) were randomized in a different days to control session with no exercise or exercise session consisting of @ laps of the following circuit : knee extension , bench press , knee flexion , rowing in the prone position , squats , shoulder press , and @ min of aerobic exercise at @-@ % of age-predicted maximum heart rate and/or @ on the Borg Rating of Perceived Exertion -LSB- scale of @ to @ -RSB- .


The sets of resistance exercise consisted of @ repetitions at ~ @ % of the estimated @ repetition maximum test .


Systolic blood pressure ( SBP ) and diastolic blood pressure ( DBP ) were measured at rest and during @h of recovery in both experimental sessions .


After that , blood pressure reactivity ( BPR ) was evaluated using the Cold Pressor Test .


During @h of exercise recovery , there was a reduction in SBP ( @-@ mmHg ) and DBP ( @-@ mmHg ) in relation to pre-session rest ( p < @ ) , while this reduction was not observed in the control session .


A decline in BPR ( @-@ mmHg ; p < @ ) was observed @h post-exercise session , but not in the control session .


Post-exercise reductions in SBP and DBP were significantly correlated with BPR reductions ( r = @-@ @ ; p < @ ) .


A combined exercise circuit session at moderate intensity promoted subsequent post-exercise hypotension and acutely attenuated BPR in response to a cardiovascular stress test .


In addition , the post-exercise BP reduction was correlated with BPR attenuation in healthy adults of both genders .


Major depressive disorder ( MDD ) is the leading cause of disability in the developed world , yet broadly effective treatments remain elusive .


Up to @ % of patients with depression are unresponsive to at least two trials of antidepressant medication and thus have `` treatment-resistant depression '' ( TRD ) .


There is an urgent need for cost-effective , non-pharmacologic , evidence-based treatments for TRD .


Mindfulness-Based Cognitive Therapy ( MBCT ) is an effective treatment for relapse prevention and residual depression in major depression , but has not been previously studied in patients with TRD in a large randomized trial .


The purpose of this study was to evaluate whether MBCT is an effective augmentation of antidepressants for adults with MDD who failed to respond to standard pharmacotherapy .


MBCT was compared to an active control condition , the Health-Enhancement Program ( HEP ) , which incorporates physical activity , functional movement , music therapy and nutritional advice .


HEP was designed as a comparator condition for mindfulness-based interventions to control for non-specific effects .


Originally investigated in a non-clinical sample to promote stress reduction , HEP was adapted for a depressed population for this study .


Individuals age @ and older with moderate to severe TRD , who failed to respond to at least two trials of antidepressants in the current episode , were recruited to participate .


All participants were taking antidepressants ( Treatment as usual ; TAU ) at the time of enrollment .


After signing an informed consent , participants were randomly assigned to either MBCT or HEP condition .


Participants were followed for @year and assessed at weeks @-@ , @ , @ , @ , and @ .


Change in depression severity , rate of treatment response and remission after @weeks were the primary outcomes measured by the clinician-rated Hamilton Depression Severity Rating ( HAM-D ) @-item scale .


The participant-rated Quick Inventory of Depression Symptomology ( QIDS-SR ) @-item scale was the secondary outcome measure of depression severity , response , and remission .


Treatment-resistant depression entails significant morbidity and has few effective treatments .


We studied the effect of augmenting antidepressant medication with MBCT , compared with a HEP control , for patients with TRD .


Analyses will focus on clinician and patient assessment of depression , participants ' clinical global impression change , employment and social functioning scores and quality of life and satisfaction ratings .


To assess the long-term effect on symptoms and quality of life of esomeprazole @mg once daily , a recommended dose for maintenance therapy of gastroesophageal reflux disease ( GERD ) .


This is a post hoc analysis of @ year data from patients in the LOTUS trial ( ClinicalTrials.gov identifier : NCT@ ) who were randomized to esomeprazole @mg once daily .


All participants had chronic , symptomatic GERD responsive to treatment .


Gastrointestinal symptoms were assessed by physicians and by using patient-reported outcome instruments .


Investigations included gastrointestinal endoscopy ( with biopsy sampling ) , @ hour esophageal pH monitoring and laboratory measurements .


In total , @ of @ patients randomized to esomeprazole @mg once daily remained on this dose until the end of follow-up or study discontinuation , whereas @ patients had their dose increased because of inadequate symptom control ( of these , @ subsequently returned to the allocated dose ) .


On logistic regression , a long objectively defined GERD history , smoking , female sex , absence of Helicobacter pylori infection and high supine baseline acid reflux into the esophagus were associated with an increased likelihood of requiring dose escalation to esomeprazole @mg daily ( all p < @ ) .


Symptoms were fairly stable and quality of life was normal throughout follow-up in patients remaining on esomeprazole @mg once daily , with no more than mild symptom severity , and mean ( standard deviation ) percentage time with intraesophageal pH < @ was reduced from @ ( @ ) pre-randomization to @ ( @ ) at @ months and @ ( @ ) at @ years .


The number of serious adverse events was low ( @ per patient per year ) .


Post hoc analysis with no control group .


Esomeprazole at a maintenance dose of @mg once daily offers effective long-term treatment for chronic GERD in patients initially responsive to the medication , with durable symptom control and sustained reductions in intraesophageal acid exposure .


In the Systolic Hypertension in Europe trial ( NCT@ ) , we investigated whether systolic blood pressure variability determines prognosis over and beyond level .


Using a computerised random function and a double-blind design , we randomly allocated @ patients ( @ years ) with isolated systolic hypertension ( @-@ / < @ mm Hg ) to active treatment or matching placebo .


Active treatment consisted of nitrendipine ( @-@ mg/day ) with possible addition of enalapril ( @-@ mg/day ) and/or hydrochlorothiazide ( @-@ @ mg/day ) .


We assessed whether on-treatment systolic blood pressure level ( SBP ) , visit-to-visit variability independent of the mean ( VIM ) or within-visit variability ( WVV ) predicted total ( n = @ ) or cardiovascular ( n = @ ) mortality or cardiovascular ( n = @ ) , cerebrovascular ( n = @ ) or cardiac ( n = @ ) endpoints .


At @ years , mean between-group differences were @ mm Hg ( p < @ ) for SBP , @ units ( p = @ ) for VIM , and @ mm Hg ( p = @ ) for WVV .


Active treatment reduced ( p@ @ ) cardiovascular ( -@ % ) , cerebrovascular ( -@ % ) and cardiac ( -@ % ) endpoints .


In analyses dichotomised by the median , patients with low vs. high VIM had similar event rates ( p@ @ ) .


Low vs. high WVV was not associated with event rates ( p@ @ ) , except for total and cardiovascular mortality on active treatment , which were higher with low WVV ( p@ @ ) .


In multivariable-adjusted Cox models , SBP predicted all endpoints ( p@ @ ) , whereas VIM did not predict any ( p@ @ ) .


Except for an inverse association with total mortality ( p = @ ) , WVV was not predictive ( p@ @ ) .


Sensitivity analyses , from which we excluded blood pressure readings within @ months after randomisation , @ months prior to an event or both were confirmatory .


The double-blind placebo-controlled Syst-Eur trial demonstrated that blood-pressure lowering treatment reduces cardiovascular complications by decreasing level but not variability of SBP .


Higher blood pressure level , but not higher variability , predicted risk .


The aim of the study was to compare the effect of six ( A@ regimen ) vs two meals a day , breakfast and lunch ( B@ regimen ) , on body weight , hepatic fat content ( HFC ) , insulin resistance and beta cell function .


In a randomised , open , crossover , single-centre study ( conducted in Prague , Czech Republic ) , we assigned @ patients with type @ diabetes treated with oral hypoglycaemic agents , both men and women , age @-@ years , BMI @-@kg / m ( @ ) and HbA@c @-@ @ % ( @-@mmol / mol ) , to follow two regimens of a hypoenergetic diet , A@ and B@ , each for @weeks .


Randomisation and allocation to trial groups ( n = @ and n = @ ) were carried out by a central computer system .


Individual calculations of energy requirements for both regimens were based on the formula : ( resting energy expenditure@ @ ) -@,@ kJ .


The diet in both regimens had the same macronutrient and energy content .


HFC was measured by proton magnetic resonance spectroscopy .


Insulin sensitivity was measured by isoglycaemic-hyperinsulinaemic clamp and calculated by mathematical modelling as oral glucose insulin sensitivity ( OGIS ) .


Beta cell function was assessed during standard meal tests by C-peptide deconvolution and was quantified with a mathematical model .


For statistical analysis , @ crossover ANOVA was used .


The intention-to-treat analysis included all participants ( n = @ ) .


Body weight decreased in both regimens ( p < @ ) , more for B@ ( -@ kg ; @ % CI -@ , -@ kg for A@ vs -@ kg ; @ % CI -@ , -@ kg for B@ ; p < @ ) .


HFC decreased in response to both regimens ( p < @ ) , more for B@ ( -@ % ; @ % CI -@ % , -@ % for A@ vs -@ % ; @ % CI -@ % , -@ % for B@ ; p = @ ) .


Fasting plasma glucose and C-peptide levels decreased in both regimens ( p < @ ) , more for B@ ( p = @ and p = @ , respectively ) .


Fasting plasma glucagon decreased with the B@ regimen ( p < @ ) , whereas it increased ( p = @ ) for the A@ regimen ( p < @ ) .


OGIS increased in both regimens ( p < @ ) , more for B@ ( p = @ ) .


No adverse events were observed for either regimen .


Eating only breakfast and lunch reduced body weight , HFC , fasting plasma glucose , C-peptide and glucagon , and increased OGIS , more than the same caloric restriction split into six meals .


These results suggest that , for type @ diabetic patients on a hypoenergetic diet , eating larger breakfasts and lunches may be more beneficial than six smaller meals during the day .


Trial registration ClinicalTrials.gov number , NCT@ , completed .


Funding Grant NT/@ -@ from Ministry of Health , Prague , Czech Republic and the Agency of Charles University - GAUK No @ .


Invasive treatment ( coronary angiography and intervention if feasible ) of patients with acute coronary syndrome ( ACS ) has been shown to lead to better outcomes than medical therapy alone , but the elderly have been under-represented in many of the studies .


In the elderly , medical therapy is common in ACS .


Fear of complications related to the procedure and unclear benefit in older patients are common reasons for invasive procedures being withheld .


Our hypothesis is that invasive treatment of elderly patients with ACS will lead to a better outcome in terms of survival and quality of life than medical therapy alone , with acceptable risk .


This multicenter , randomized controlled trial of patients @ years of age and over has two parallel treatment arms , a medical group and an invasive group .


In Swedish hospitals , @ patients with non-ST elevation myocardial infarction or unstable angina will be randomized to medical or invasive treatment strategy .


The primary outcome measure is the combined endpoint major adverse cardiac or cerebrovascular event ( MACCE ) within one year .


Secondary outcome measures include quality of life , angina , and adverse events such as bleeding .


Assessments will be conducted during hospitalization , at @ month after allocation , and at @ months .


This study seeks to determine the efficacy and safety of invasive and medical treatment strategies in the elderly with ACS .


The study is currently recruiting .


Elevated high-sensitivity troponin is associated with increasing disease severity in patients with stable heart failure with reduced ejection fraction , but less is known about the association in heart failure with preserved ejection fraction .


We examined the prevalence of elevated high-sensitivity troponin T ( hs-TnT ) in @ patients with heart failure with preserved ejection fraction enrolled in the Prospective comparison of angiotensin receptor neprilysin inhibitor with angiotensin receptor blocker on Management Of heart failUre with preserved ejectioN fracTion ( PARAMOUNT ) trial , in which the angiotensin receptor neprilysin inhibitor LCZ@ reduced markers of heart failure severity compared with valsartan .


We assessed the association between hs-TnT and cardiac structure and function , and the effect of LCZ@ , compared with valsartan , on hs-TnT over @ weeks .


Elevated hs-TnT in the myocardial injury range ( > @ g/L ) was found in @ % of patients and was associated with older age , history of diabetes mellitus , higher N-terminal pro-brain natriuretic peptide , lower estimated glomerular filtration rate , and larger left atrial size , left ventricular volume , and mass .


LCZ@ treatment reduced hs-TnT to a greater extent at @ weeks ( @ % reduction ; P = @ ) and at @ weeks ( @ % reduction ; P = @ ) compared with valsartan .


Troponin T was elevated in a substantial number of patients enrolled in a heart failure with preserved ejection fraction clinical trial and was associated with abnormalities of cardiac structure , function , and elevated baseline N-terminal pro-brain natriuretic peptide .


Decreases in hs-TnT with LCZ@ in parallel with improvement in N-terminal pro-brain natriuretic peptide and left atrial size suggest that the angiotensin receptor neprilysin inhibitor LCZ@ may reduce this measure of myocardial injury in heart failure with preserved ejection fraction .


Investigations meeting current standards are limited for the effect of house dust mite ( HDM ) allergy immunotherapy in asthmatic patients .


This trial investigated the efficacy and safety of a standardized quality ( SQ ; allergen standardization method proprietary to the trial sponsor ) HDM SLIT-tablet ( ALK , Hrsholm , Denmark ) in adults and adolescents with HDM respiratory allergic disease .


This publication reports the results of the endpoints related to asthma .


Six hundred four subjects @ years or older with HDM allergic rhinitis and mild-to-moderate asthma were randomized @:@:@:@ to double-blind daily treatment with one of @ active doses ( @ , @ , or @ SQ-HDM ) or placebo .


Their use of inhaled corticosteroid ( ICS ) was standardized and adjusted at baseline and the end of treatment to the lowest dose providing asthma control .


The primary end point was a reduction in ICS dose from the individual subject 's baseline dose after @ year of treatment .


The primary analysis revealed a mean difference between @ SQ-HDM and placebo in the reduction in daily ICS dose of @ g ( P = @ ) .


Relative mean and median reductions were @ % and @ % for @ SQ-HDM and @ % and @ % for placebo , respectively .


No statistically significant differences were observed for the other assessed asthma parameters , reflecting the intended controlled status of the trial subjects .


The most common adverse events were local reactions in the mouth .


The rate and severity of adverse events were higher for @ and @ SQ-HDM than for @ SQ-HDM and placebo .


Efficacy in mild-to-moderate asthma of @ SQ-HDM relative to placebo was demonstrated by a moderate statistically significant reduction in the ICS dose required to maintain asthma control .


All active doses were well tolerated .


Pill-taking , expectations and therapeutic alliance may account for much of the benefit of medication and placebo treatment for major depressive disorder ( MDD ) .


Aims To examine the effects of medication , placebo and supportive care on treatment outcome , and the relationships of expectations and therapeutic alliance to improvement .


A total of @ participants were randomised to @ weeks of treatment with supportive care alone or combined with double-blind treatment with placebo or antidepressant medication .


Expectations of medication effectiveness , general treatment effectiveness and therapeutic alliance were measured ( trial registration at ClinicalTrials.gov : NCT@ ) .


Medication or placebo plus supportive care were not significantly different but had significantly better outcome than supportive care alone .


Therapeutic alliance predicted response to medication and placebo ; expectations of medication effectiveness at enrolment predicted only placebo response .


Pill treatment yielded better outcome than supportive care alone .


Medication expectations uniquely predicted placebo treatment outcome and were formed by time of enrolment , suggesting that they were shaped by prior experiences outside the clinical trial .


Adrenocortical carcinoma is a rare , aggressive cancer for which few treatment options are available .


Linsitinib ( OSI-@ ) is a potent , oral small molecule inhibitor of both IGF-@R and the insulin receptor , which has shown acceptable tolerability and preliminary evidence of anti-tumour activity .


We assessed linsitinib against placebo to investigate efficacy in patients with advanced adrenocortical carcinoma .


In this international , double-blind , placebo-controlled phase @ study , adult patients with histologically confirmed locally advanced or metastatic adrenocortical carcinoma were recruited at clinical sites in nine countries .


Patients were randomly assigned ( @:@ ) twice-daily @ mg oral linsitinib or placebo via a web-based , centralised randomisation system and stratified according to previous systemic cytotoxic chemotherapy for adrenocortical carcinoma , Eastern Cooperative Oncology Group performance status , and use of one or more oral antihyperglycaemic therapy at randomisation .


Allocation was concealed by blinded block size and permuted block randomisation .


The primary endpoint was overall survival , calculated from date of randomisation until death from any cause .


The primary analysis was done in the intention-to-treat population .


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


Between Dec @ , @ , and July @ , @ , @ patients were enrolled , of whom @ were assigned to linsitinib and @ to placebo .


The trial was unblinded on March @ , @ , based on data monitoring committee recommendation due to the failure of linsitinib to increase either progression-free survival or overall survival .


At database lock and based on @ deaths , no difference in overall survival was noted between linsitinib and placebo ( median @ days -LSB- @ % CI @-@ -RSB- vs @ days -LSB- @-@ -RSB- ; hazard ratio @ -LSB- @ % CI @-@ -RSB- ; p = @ ) .


The most common treatment-related adverse events of grade @ or worse in the linsitinib group were fatigue ( three -LSB- @ % -RSB- patients vs no patients in the placebo group ) , nausea ( two -LSB- @ % -RSB- vs none ) , and hyperglycaemia ( two -LSB- @ % -RSB- vs none ) .


No adverse events in the linsitinib group were deemed to be treatment related ; one death ( due to sepsis and megacolon ) in the placebo group was deemed to be treatment related .


Linsitinib did not increase overall survival and so can not be recommended as treatment for this general patient population .


Further studies of IGF-@R and insulin receptor inhibitors , together with genetic profiling of responders , might pave the way toward individualised and improved therapeutic options in adrenocortical carcinoma .


Many patients experience moderate to severe postoperative pain .


Nitrous oxide ( NO ) exerts analgesia by inhibition of N-methyl-D-aspartate receptors .


Ketamine , another N-methyl-D-aspartate receptor antagonist , reduces postoperative opioid consumption and pain .


A similar effect of NO is plausible , yet understudied .


The goal of this study was to determine the effects of NO anesthesia on early postsurgical opioid consumption and pain .


This was a retrospective , secondary analysis of the Vitamins In Nitrous Oxide trial , where @ patients undergoing general anesthesia for noncardiac surgery received @ % NO and @ received no NO ( otherwise , inclusion/exclusion criteria were identical ) .


Exclusion criteria for this study were regional anesthesia , not extubated after surgery , transfer to intensive care unit , no available postanesthesia care unit record , postsurgical sedation , or treated with naloxone .


Primary outcomes were cumulative opioid consumption measured in morphine equivalents and pain scores during the immediate recovery phase .


Four hundred forty-two patients met inclusion criteria .


No difference in intraoperative and postoperative opioid consumption was observed between patients who received NO ( n = @ ) and patients who did not ( n = @ ) .


The median -LSB- interquartile range -RSB- postoperative morphine equivalent dose was @ mg -LSB- @-@ @ mg -RSB- for patients who received NO and @ mg -LSB- @-@ @ mg -RSB- for patients who did not ( P = @ ) .


The maximum pain score was @ -LSB- @-@ -RSB- for patients who received NO versus @ -LSB- @-@ -RSB- for patients who received NO-free anesthesia ( P = @ ) .


The prevalence of moderate to severe pain was @ % for patients who received NO and @ % for patients who did not ( P = @ ) .


Nitrous oxide anesthesia was not associated with decreased opioid administration , pain , or incidence of moderate to severe pain in the early postoperative phase .


To determine whether electroacupuncture ( EA ) intervention combined with general anesthesia ( GA ) strategy can reduce early post-operative morbidity and medical costs in patients undergoing heart valve replacement operation under cardiopulmonary bypass .


A total of @ heart valve replacement surgery patients undergoing cardiopulmonary bypass were randomly divided into GA and EA + GA groups ( n = @ in each group ) .


Patients of the GA group were given with intravenous injection of Fentanyl , Midazolam , Vecuronium Bromide , etc. and routine tracheal intubation .


EA ( @-@ Hz , @-@ @ mA ) was applied to bilateral Zhongfu ( LU @ ) , Chize ( LU @ ) and Ximen ( PC @ ) beginning about @ mm before the surgery in the EA + GA group .


Endotracheal intubation was not employed but only prepared as a standby for patients of the EA + GA group .


The dosage of narcotic drugs , duration of surgery , duration of aertic blockage , rate of cardiac re-beating , volumes of post-operative blood transfusion , discharge volume , cases of post-operative pulmonary infection , vocal cord injury , and the time of first bed-off , first eating and duration in intensive care unit ( IOU ) residence .


etc. were recorded .


The successful rates of heart valve replacement surgery were similar in both GA and EA + GA groups .


Compared with the GA group , the dosages of Fentanyl , Midazolam and Vecuronium of the EA + GA group were significantly lower ( P < @ , P < @ ) , the numbers of patients needing blood-transfusion , antibiotics treatment , and suffering from pulmonary infection were fewer , the time of first bed-off and duration of hospitalizetion and IOU residence were considerably shorter ( P < @ , P < @ ) and the total medical cost was obviously lower ( P < @ ) in the EA + GA group .


EA combined with general anesthesia strategy for heart valve replacement surgery without endotracheal intubation is safe and can reduce post-operative morbidity and medical costs in patients undergoing heart valve replacement surgery under cardiopulmonary bypass .


To assess the cost-effectiveness of a nurse facilitated , cognitive behavioural self-management programme for patients with heart failure compared with usual care including the un-facilitated access to the same manual , from the perspective of the NHS .


Data were obtained from a pragmatic , multi-centre , randomized controlled ` open ' trial conducted in seven centres in the UK between @ and @ .


Effectiveness was estimated as Quality-Adjusted Life Years .


Resource use was measured prospectively on all patients using information provided by patients in postal questionnaires , case-note review , electronic record review and interviews with patients .


Unit costs were obtained from the literature and applied to the relevant resource use to estimate total costs .


Multiple imputation was used to handle missing data .


There were no substantial differences in the utility scores between treatment groups in all follow-up assessments , in the use of medication or outpatient visits and both groups report a similar frequency of contact with health care professionals .


After controlling for baseline utility and using imputed dataset , treatment was associated with a reduction in QALY of @ and a additional cost of @ .


The probability that the intervention is cost-effective for thresholds between @,@ and @,@ is around @ % .


There is little evidence that the addition of the intervention had any effect on costs or outcomes .


The uncertainty around both estimates of cost and effectiveness mean that it is not reasonable to make recommendations based on cost-effectiveness alone .


Major depressive disorder ( MDD ) is frequently associated with underactivity of the dorsolateral prefrontal cortex ( DLPFC ) which has led to this brain region being identified as an important target for the development of neurobiological treatments .


Transcranial direct current stimulation ( tDCS ) administered to the DLPFC has antidepressant efficacy , however the magnitude of antidepressant outcomes are limited .


Concurrent cognitive activity has been shown to enhance tDCS induced stimulation effects .


Cognitive control training ( CCT ) is a new cognitive therapy for MDD that aims to enhance DLPFC activity via behavioral methods .


We tested the hypothesis that co-administration of DLPFC tDCS and CCT would result in a greater reduction in depressive symptomology than administration of tDCS or CCT alone .


@ adult participants with MDD were randomized into a three-arm sham-controlled between-groups pilot study comparing the efficacy of @ mA tDCS + CCT , sham tDCS + CCT and sham CCT + @ mA tDCS ( @ sessions administered on consecutive working days ) .


Blinded assessments of depression severity and cognitive control were conducted at baseline , end of treatment and a three week follow up review .


All three treatment conditions were associated with a reduction in depression severity at the end of five treatment sessions .


However , only administration of tDCS + CCT resulted in sustained antidepressant response at follow up , the magnitude of which was greater than that observed immediately following conclusion of the treatment course .


The results provide preliminary evidence that concurrent CCT enhances antidepressant outcomes from tDCS .


In the current sample , participants receiving concurrent tDCS and CCT continued to improve following cessation of treatment .


The clinical superiority of a combined therapeutic approach was apparent even in a small sample and following a relatively short treatment course .


Isolated systolic hypertension is a highly prevalent disease among the elderly .


The little available evidence on the efficacy of nitrates for treating the disease is based on small experimental studies .


We performed a multicenter , randomized , double-blind , phase III , placebo-controlled trial in @ patients aged over @ years with refractory isolated systolic hypertension .


Patients were randomized to placebo or @ mg/day of extended-release isosorbide mononitrate added to standard therapy and titrated to @ mg/day at week @ if blood pressure exceeded @/@ mmHg.The primary objective was to assess the effect on clinical pulse pressure of extended-release isosorbide mononitrate added to standard therapy in patients aged over @ years with refractory isolated systolic hypertension after @ months of treatment.The secondary objectives were as follows : to quantify the effect of adding the study drug on central blood pressure and vascular compliance using the augmentation index and pulse wave velocity ; to evaluate the safety profile by recording adverse effects ( frequency , type , severity ) and the percentage of patients who had to withdraw from the trial because of adverse events ; to quantify the percentage of patients who reach a clinical systolic blood pressure < @ mmHg or < @ mmHg measured by ambulatory blood pressure monitoring ; and to quantify the change in pulse pressure measured by ambulatory blood pressure monitoring .


Few clinical trials have been carried out to test the effect of oral nitrates on isolated systolic hypertension , even though these agents seem to be effective .


Treatment with extended-release isosorbide mononitrate could improve control of systolic blood pressure without severe side effects , thus helping to reduce the morbidity and mortality of the disease .


Acne scarring remains a stubborn clinical problem .


Few treatments have been shown to bedefinitely effective for this problem .


Polymethylmethacrylate ( PMMA ) microspheres in collagen ( ArteFill , Suneva Medical Inc , Santa Barbara , CA ) have shown long-term benefit for nasolabial fold treatment .


A pilot study has shown benefit for PMMA-collagen in atrophic acne scarring .


We sought to demonstrate the safety and effectiveness of PMMA-collagen for acne scarring in a controlled , blinded trial .


Subjects with at least @ moderate to severe rolling , atrophic scars randomly received PMMA-collagen or saline injections .


Subjects underwent up to @ injection sessions and were followed up for @ months .


Efficacy was assessed using a validated rating scale for each scar .


In all , @ subjects underwent injections .


Success was achieved by @ % of those treated with PMMA-collagen compared with @ % of control subjects ( P = @ ) .


The treatment showed excellent safety with generally mild , reversible adverse events .


No significant differences in efficacy or safety were noted between genders , for darker skin types , or in older age groups .


Subjects were followed up for only @ months .


PMMA-collagen demonstrates substantial effectiveness in the treatment of atrophic acne scars of the face while maintaining an excellent safety profile .


Further follow-up should be undertaken to demonstrate longer-term benefit and safety .


Parenteral artesunate is recommended as first-line therapy for severe malaria .


While its efficacy is firmly established , data on safety are still incomplete .


Delayed hemolysis has been described in hyperparasitemic nonimmune travelers , but it is unknown if African children are equally at risk .


Children aged @ to @ months with severe malaria were followed up after treatment with parenteral artesunate in Lambarn , Gabon , and Kumasi , Ghana .


The primary outcome was incidence of delayed hemolysis on day @ .


In total , @ children contributed complete data sets necessary for primary outcome assessment .


Delayed hemolysis was detected in @ children ( @ % ) , with @ child reaching a nadir in hemoglobin of @ g/dL .


Patients with delayed hemolysis had higher parasite counts on admission ( geometric mean parasite densities ( GMPD ) @ @/L vs @ @/L , P = @ ) and were younger ( median age : @ months vs @ months , P = @ ) than the rest of the cohort .


No correlation with sickle cell trait or glucose-@-phosphate-dehydrogenase deficiency was observed .


Delayed hemolysis is a frequent and relevant complication in hyperparasitemic African children treated with parenteral artesunate for severe malaria .


Physicians should be aware of this complication and consider prolonged follow-up .


Increased arterial stiffness as measured by aortic pulse wave velocity ( aPWV ) predicts cardiovascular events and mortality and is elevated in patients with COPD .


Prior investigation suggests that a long-acting - agonist ( LABA ) / inhaled corticosteroid ( ICS ) lowers aPWV in patients with baseline aPWV @ m/s .


This study compared the effect of the ICS/LABA fluticasone furoate/vilanterol ( FF/VI ) , @/@ g , delivered via the ELLIPTA dry powder inhaler , with tiotropium bromide ( TIO ) , @ g , on aPWV .


This multicenter , randomized , blinded , double-dummy , parallel-group , @-week study compared FF/VI and TIO , both administered once daily .


The primary end point was aPWV change from baseline at @ weeks .


Safety end points included adverse events ( AEs ) , vital signs , and clinical laboratory tests .


Two hundred fifty-seven patients with COPD and aPWV @ m/s were randomized ; @ % had prior cardiovascular events and/or risk .


The mean difference in aPWV between FF/VI and TIO at week @ was not significant ( P = @ ) .


Because the study did not contain a placebo arm , a post hoc analysis was performed to show that both treatments lowered aPWV by an approximate difference of @ m/s compared with baseline .


The proportion of patients reporting AEs was similar with FF/VI ( @ % ) and TIO ( @ % ) .


There were no changes in clinical concern for vital signs or clinical laboratory tests .


No differences on aPWV were observed between FF/VI and TIO .


However , further studies with a placebo arm are required to establish definitively whether long-acting bronchodilators lower aPWV .


Both treatments demonstrated an acceptable tolerability profile .


Vandetanib is a selective inhibitor of vascular endothelial growth factor receptor ( VEGFR ) , epidermal growth factor receptor ( EGFR ) and rearranged during transfection ( RET ) signalling , indicated for the treatment of medullary thyroid cancer .


We investigated potential drug-drug interactions between vandetanib and metformin -LSB- organic cation transporter @ ( OCT@ ) substrate ; NCT@ -RSB- ; digoxin -LSB- P-glycoprotein ( P-gp ) substrate ; NCT@ -RSB- ; midazolam -LSB- cytochrome P@ ( CYP ) @A@ substrate ; NCT@ -RSB- ; omeprazole ( proton pump inhibitor ) or ranitidine ( histamine H@-receptor antagonist ; both NCT@ ) .


Four open-label , phase I studies were conducted in healthy volunteers : n = @ ( metformin ) , n = @ ( digoxin ) , n = @ ( midazolam ) , n = @ ( omeprazole ) , n = @ ( ranitidine ) .


Three of these comprised the following regimens : metformin @mgvandetanib @mg , midazolam @ mgvandetanib @mg , or digoxin @ mgvandetanib @mg .


The randomized study comprised vandetanib @mg alone and then either ( i ) omeprazole @mg ( days @-@ ) , and omeprazole + vandetanib ( day @ ) ; or ( ii ) ranitidine @mg ( day @ ) , and ranitidine + vandetanib ( day @ ) .


The primary objective assessed metformin , digoxin , midazolam and vandetanib pharmacokinetics .


Vandetanib + metformin increased metformin area under the plasma concentration-time curve from zero to infinity ( AUC@ - ) and maximum observed plasma concentration ( Cmax ) by @ and @ % , respectively , and decreased the geometric mean metformin renal clearance ( CLR ) by @ % versus metformin alone .


Vandetanib + digoxin increased digoxin area under the concentration-time curve from zero to the last quantifiable concentration ( AUC@-last ) and Cmax by @ and @ % , respectively , versus digoxin alone , with only a @ % decrease in CLR .


Vandetanib had no effect on midazolam exposure .


Vandetanib exposure was unchanged during co-administration with omeprazole/ranitidine .


Treatment combinations were generally well tolerated .


Patients receiving vandetanib with metformin/digoxin may require additional monitoring of metformin/digoxin , with dose adjustments where necessary .


Vandetanib with CYP@A@ substrates or omeprazole/ranitidine is unlikely to result in clinically relevant drug-drug interactions .


To compare efficacy and safety of hydroxychloroquine with pioglitazone in type @ diabetes mellitus ( T@DM ) .


This double-blind study randomized @ uncontrolled type @ diabetes patients ( HbA@c @ % and @ % ) , post @ months ' treatment with glimepiride/gliclazide and metformin , to additionally receive hydroxychloroquine @mg/day ( n = @ ) or pioglitazone @mg/day ( n = @ ) for @ weeks .


Efficacy was assessed by changes in HbA@c , fasting ( FBG ) and post-prandial ( PPG ) blood glucose at Week @ and Week @ .


At Week @ and Week @ , HbA@c , FBG and PPG significantly reduced from baseline in both groups .


Mean reduction in glycemic parameters at Week @ ( HbA@c : -@ % vs -@ % , p = @ ; FBG : -@ mmol/L vs -@ mmol/L , p = @ ; PPG : -@ mmol/L vs -@ mmol/L , p = @ ) and Week @ ( HbA@c : -@ % vs -@ % , p = @ ; FBG : -@ mmol/L vs -@ mmol/L , p = @ ; PPG : -@ mmol/L vs -@ mmol/L , p = @ ) was not significantly different between the hydroxychloroquine and pioglitazone groups .


Change in total cholesterol ( TC ) and LDL-C was significant in favor of hydroxychloroquine ( TC : -@ mmol/L vs @ mmol/L , p = @ ; LDL-C : -@ mmol/L vs @ mmol/L , p = @ ) .


Triglycerides significantly reduced in both groups at Week @ .


Mean HDL-C remained unchanged .


Study treatments were well tolerated .


With favorable effects on glycemic parameters and lipids , hydroxychloroquine may emerge as well tolerated therapeutic option for T@DM .


The sample size for this study was small .


However , based on the encouraging results of this proof-of-concept study , longer duration studies in larger population can be conducted to further confirm these findings .


TRIAL REGISTRATION DETAILS : Clinical Trial Registry-India URL : http://ctri.nic.in , Registration Number : CTRI/@/@ / @ .


Swirling flow , organized in vortices , contributes to adequate left ventricular function .


In this study , we apply a novel echocardiographic flow-mapping technique , vector flow mapping ( VFM ) , to evaluate the main characteristics of left ventricular vortices and its relation to filling parameters .


Forty-eight subjects underwent conventional transthoracic echocardiographic examination with additional intracardiac flow assessment with VFM using a Aloka Alpha-@ system and experimental VFM analysis software .


To analyze vortex behavior , its rotation direction , duration , location inside the left ventricle , size , and intensity were assessed in apical long-axis view .


Its relation to conventional left ventricular filling parameters was then analyzed .


Two vortex components were consistently identified following each transmitral filling wave .


The anterior component of these visualized vortices was analyzed , due to its higher significance in the cardiac cycle , following early filling ( V@ ) and atrial contraction ( V@ ) .


Differences were observed in several aspects of vortex behavior between V@ and V@ , particularly in patients with normal left ventricular filling parameters .


These differences may be related to varying roles of vortices in different periods of the cardiac cycle .


Vector flow mapping allowed visualization and measurement of several parameters defining vortex behavior inside the cardiac cycle .


The differences observed in these parameters between vortices in different phases of the cardiac cycle may be related to their role in optimizing cardiac function .


Assess golimumab efficacy/safety through @years in patients with active ankylosing spondylitis ( AS ) .


@ patients with AS were randomly assigned to placebo , golimumab @mg or @mg every @weeks .


At week @ , patients with inadequate response early escaped with blinded dose adjustments ( placebo to @mg , @mg to @mg ) .


At week @ , all patients receiving placebo crossed over to @mg .


Blinded active therapy continued through week @ ; from week @ to week @ , the golimumab dose could be adjusted .


Intent-to-treat and observed efficacy data were assessed by randomised treatment groups .


At week @ , and with > @ years of golimumab , overall intent-to-treat Assessment in SpondyloArthritis international Society criteria for @ % improvement ( ASAS@ ) and ASAS@ response rates were @ % ( @/@ ) and @ % ( @/@ ) , respectively ; Bath AS Disease Activity Index @ % improvement response was @ % ( @/@ ) .


Observed response rates among the @ ( @ % ) patients who continued golimumab through week @ were consistent , albeit somewhat higher .


Among patients who increased golimumab from @ to @mg , @ % ( @/@ ) and @ % ( @/@ ) achieved ASAS@/ASAS@ responses , respectively , following @ consecutive doses of golimumab @mg .


Golimumab safety through week @ was similar to that through week @ regardless of dose .


Clinical improvements observed in patients treated with golimumab through week @ were sustained through week @ ( @years ) .


Long-term golimumab safety is consistent with that of other established tumour-necrosis-factor-antagonists .


Attention-Deficit/Hyperactivity Disorder ( ADHD ) in adults is one of the predictive and treatable risk factors for delinquency , including intimate partner violence ( IPV ) .


Effective treatment of IPV needs to address personal dynamic risk factors , offender typology , and dynamics of the domestic violence .


It is unknown whether treatment of ADHD symptoms contributes to a decrease in IPV .


The ITAP study aims to investigate the relationship between treatment of ADHD symptoms and IPV in patients in forensic mental health care .


Moreover , this study examines the role of comorbid psychopathology , subtype of the offender , and dynamics of the domestic violence .


The ITAP study is a longitudinal observational study .


Participants are followed one year through various assessments : one before starting treatment ( t@ ) , and four during treatment ( @ , @ , @ and @ weeks after start of the treatment ) .


All participants receive treatment for IPV , ADHD , and comorbid psychopathology , if present .


The primary outcome measure is the change in severity of IPV ; the primary predictive variable is the change in severity of ADHD symptoms .


The secondary outcome measure is the observation of the therapist about change in the offender 's general violent behaviour , within and outside the partner relationship .


Data are analysed in a multiple regression model with change in severity of IPV as the dependent variable and change in severity of ADHD symptoms as the primary predictor .


Other predictive variables taken into account in the analyses are presence of comorbid psychopathology and personality disorder , subtype of the offender , and dynamics of the domestic violence .


In addition , compliance with treatment and content of the treatment are documented .


Research on the treatment process of IPV offenders and victims is complicated by many factors .


This observational design will not allow inferences about causality but may reveal clinically important factors that contribute to more effective treatment of IPV .


Nitrogen dioxide ( NO@ ) , a ubiquitous atmospheric pollutant , may enhance the asthmatic response to allergens through eosinophilic activation in the airways .


However , the effect of NO@ on inflammation without allergen exposure is poorly studied .


We investigated whether repeated peaks of NO@ , at various realistic concentrations , induce changes in airway inflammation in asthmatics .


Nineteen nonsmokers with asthma were exposed at rest in a double-blind , crossover study , in randomized order , to @ ppb NO@ , @ ppb NO@ , or clean air once for @ min on day @ and twice for @ min on day @ .


The three series of exposures were separated by @ weeks .


The inflammatory response in sputum was measured @ hr ( day @ ) , @ hr ( day @ ) , and @ hr ( day @ ) after the first exposure , and compared with baseline values measured twice @-@ days before the first exposure .


Compared with baseline measurements , the percentage of eosinophils in sputum increased by @ % after exposure to @ ppb NO@ ( p = @ ) but did not change significantly after exposure to @ ppb .


The slope of the association between the percentage of eosinophils and NO@ exposure level was significant ( p = @ ) .


Eosinophil cationic protein in sputum was highly correlated with eosinophil count and increased significantly after exposure to @ ppb NO@ ( p = @ ) .


Lung function , which was assessed daily , was not affected by NO@ exposure .


We observed that repeated peak exposures of NO@ performed without allergen exposure were associated with airway eosinophilic inflammation in asthmatics in a dose-related manner .


Musculoskeletal pain is a major contributor to short and long term work absence .


Patients seek care from their general practitioner ( GP ) and yet GPs often feel ill-equipped to deal with work issues .


Providing a vocational case management service in primary care , to support patients with musculoskeletal problems to remain at or return to work , is one potential solution but requires robust evaluation to test clinical and cost-effectiveness .


This protocol describes a cluster randomised controlled trial , with linked qualitative interviews , to investigate the effect of introducing a vocational advice service into general practice , to provide a structured approach to managing work related issues in primary care patients with musculoskeletal pain who are absent from work or struggling to remain in work .


General practices ( n = @ ) will be randomised to offer best current care or best current care plus a vocational advice service .


Adults of working age who are absent from or struggling to remain in work due to a musculoskeletal pain problem will be invited to participate and @ participants will be recruited .


Data collection will be through patient completed questionnaires at baseline , @ and @ months .


The primary outcome is self-reported work absence at @ months .


Incremental cost-utility analysis will be undertaken to calculate the cost per additional QALY gained and incremental net benefits .


A linked interview study will explore the experiences of the vocational advice service from the perspectives of GPs , nurse practitioners ( NPs ) , patients and vocational advisors .


This paper presents the rationale , design , and methods of the Study of Work And Pain ( SWAP ) trial .


The results of this trial will provide evidence to inform primary care practice and guide the development of services to provide support for musculoskeletal pain patients with work-related issues .


To investigate whether prophylactic postoperative NIV prevents respiratory complications following lung resection surgery in COPD patients .


In seven thoracic surgery departments , @ COPD patients undergoing lung resection surgery were randomly assigned to two groups : conventional postoperative treatment without ( n = @ ) or with ( n = @ ) prophylactic NIV , applied intermittently during @ h per day for @ h following surgery .


The primary endpoint was the rate of acute respiratory events ( ARE ) at @ days postoperatively ( ITT analysis ) .


Secondary endpoints were acute respiratory failure ( ARF ) , intubation rate , mortality rate , infectious and non-infectious complications , and duration of ICU and hospital stay .


ARE rates did not differ between the prophylactic NIV and control groups ( @/@ , @ vs. @/@ , @ % , p = @ ) .


ARF rate was @ % in the prophylactic NIV group and @ % in controls ( p = @ ) .


Re-intubation rates were similar in the prophylactic NIV and control group -LSB- @/@ ( @ % ) and @/@ ( @ % ) , respectively , p = @ -RSB- .


Mortality rates were @ and @ % in the control and prophylactic NIV groups , respectively ( p = @ ) .


Infectious and non-infectious complication rates , and duration of ICU and hospital stays were similar between groups .


Prophylactic postoperative NIV did not reduce the rate of ARE in COPD patients undergoing lung resection surgery and did not influence other postoperative complications rates , mortality rates , and duration of ICU and hospital stay .


Aspirin exacerbated respiratory disease ( AERD ) is comprised of aspirin/acetylsalicylic acid ( ASA ) sensitivity , bronchial asthma , and nasal polyposis .


Treatment of this condition is challenging and may include topical/systemic steroids , endoscopic sinus surgery , and/or aspirin desensitization .


A prospective crossover pilot study ( n = @ ) was conducted in which patients were randomized into either of @ groups with @ weeks of regular diet ( R ) or @ weeks of a low salicylate diet ( LS ) .


The study was conducted in a tertiary otolaryngology clinic .


Patients with AERD were enrolled in the study .


Subjective ( Sino-nasal Outcome Test-@ -LSB- SNOT-@ -RSB- , Nasal Sinus Symptom Scale -LSB- NSSS -RSB- , and the Asthma Control Questionnaire-@ -LSB- ACQ-@ -RSB- ) and objective outcome instruments ( Peri-Operative Sinus Evaluation -LSB- POSE -RSB- and Lund-Kennedy Endoscopic Score -LSB- LKES -RSB- ) were used to evaluate patients at baseline , @ weeks ( at crossover ) , and @ weeks .


Wilcoxon rank sum tests demonstrated that patients on the low salicylate diet had improved scores compared to their regular diet when evaluated by @ of the @ outcome measures ( SNOT-@ pLS = @ , NSSS pLS = @ , LKES pLS = @ , POSE pLS = @ ) .


Results of the pilot study indicate that implementation of a low salicylate diet improves the nasal symptoms and nasal endoscopy findings of individuals with AERD .


Further research is required to support these findings .


Although the standard treatment for venous ulcers is compression , drugs may be used as adjunctive therapy .


Simvastatin has shown potential wound-healing properties ; however , no studies have investigated its use in venous ulcers .


To assess the efficacy and safety of simvastatin in venous ulcer healing when combined with standard treatment for ulcers .


This was a randomized , double-blind , placebo-controlled trial .


Outcome measures were the proportion of healed ulcers , healing time , total surface area healed and Dermatology Life Quality Index ( DLQI ) scores .


Sixty-six patients were randomized into two groups : a simvastatin ( n = @ ) and a control ( n = @ ) group .


Among ulcers @cm , @ % were healed in the simvastatin group , and @ % were healed in the control group -LSB- relative risk ( RR ) @ , @ % confidence interval ( CI ) @-@ -RSB- .


The average healing times for ulcers @cm were @weeks and @weeks for the simvastatin and control groups , respectively ( P < @ ) .


Among ulcers > @cm , @ % closed in the simvastatin group , with a mean healing time of @weeks .


No ulcers of this size closed in the control group ( RR @ , @ % CI @-@ ) .


The simvastatin group had lower DLQI scores ( P < @ ) post-treatment .


No adverse effects were documented .


Simvastatin @mg daily , in addition to standard wound care and compression , is associated with a significant improvement in healing rate and time , as well as an improved patient quality of life when compared with placebo in the management of venous ulcers .


How platelet ( PLT ) product characteristics such as dose , source ( whole blood derived -LSB- WBD -RSB- vs. apheresis ) , storage duration , and ABO matching status affect the risks of transfusion-related adverse events ( TRAEs ) is unclear .


Similarly , more information is needed to define how recipient characteristics affect the frequency of TRAEs after PLT transfusion .


In the multicenter Platelet Dose ( `` PLADO '' ) study , pediatric and adult hematology-oncology patients with hypoproliferative thrombocytopenia were randomized to receive low-dose ( LD ) , medium-dose ( MD ) , or high-dose ( HD ) PLT prophylaxis for a pretransfusion PLT count of not more than @ ( @ ) / L. All PLT units ( apheresis or WBD ) were leukoreduced .


Post hoc analyses of PLADO data were performed using multipredictor models .


A total of @ PLT transfusions to @ patients were analyzed .


A TRAE occurred with @ PLT transfusions ( @ % ) .


The most common TRAEs were fever ( @ % of transfusions ) , allergic or hypersensitivity reactions ( @ % ) , and sinus tachycardia ( @ % ) .


Patients assigned HD PLTs were more likely than LD or MD patients to experience any TRAE ( odds ratio for HD vs. MD , @ ; @ % confidence interval , @-@ @ ; three-group comparison p = @ ) .


PLT source and ABO matching status were not significantly related to overall TRAE risk .


Compared to a patient 's first PLT transfusion , subsequent PLT transfusions were less likely to have a TRAE reported , primarily due to a lower risk of allergic or hypersensitivity reactions .


The most important PLT unit characteristic associated with TRAEs was PLT dose per transfusion .


HD PLTs may increase the risk of TRAEs , and LD PLTs may reduce the risk .


Epilepsy is a complex chronic disorder which affects health-related quality of life ( HRQOL ) , especially in women .


This study is a pragmatic randomised controlled trial involving women with epilepsy ( WWE ) over @ years of age .


One hundred eighty-two WWE entered the study and @ ( @ % ) completed it .


The t-test for comparing the final QOLIE-@ scores between groups yielded a t = -@ and confidence interval ( CI ) ( @ % ) : -@ ; -@ , p-value = @ .


The change ( ) in the QOLIE-@ score for the IG was @ points ( p-value < @ ) and for the control group it was @ ( p-value = @ ) .


With @ as the minimally important change we found a relative risk of @ ( CI : @ ; @ ) and a number needed to treat ( NNT ) of @ .


The study demonstrated that the application of a pharmaceutical care programme significantly improves HRQOL in WWE .


The NNT we found allows a recommendation to implement the PC programme for the additional benefit that would be obtained in patients ' HRQOL .


To determine the effect of moderate-intensity aerobic exercise on the quality of life ( QOL ) and physical functioning in breast cancer survivors .


We randomly assigned @ breast cancer survivors to an exercise ( N = @ ) or control group ( N = @ ) .


The exercise group trained at a moderate intensity progressing from @ to @ min over a @-week period .


The control group did not train .


Outcomes were assessed at baseline and postintervention .


The primary outcomes were overall QOL -- as assessed by the functional assessment of cancer therapy-breast ( FACT-B ) scale .


Secondary outcomes were changes in various subscales of overall QOL , and changes in body composition outcomes : body weight , body mass index , and changes in performance in a @ min walk test ( @MWT ) .


Sixty-two of @ women randomized ( @ % ) completed the study .


There were no significant differences amongst the two groups at baseline for any variable .


In the exercise group significant improvements were demonstrated for the FACT-B ( @ points , P < @ ) , functional assessment of cancer therapy-general ( FACT-G ) ( @ points , P < @ ) , the functional well-being subscale ( P < @ ) , and the emotional well-being subscale ( P < @ ) compared to the control group .


No significant changes in body weight or BMI were observed .


Exercise group showed a significant increase in @MWT ( P < @ ) .


We conclude that @ week of moderate-intensity aerobic exercise program significantly improves QOL and physical functioning in breast cancer survivors .


Future studies are needed to evaluate the effectiveness of similar exercise programs over longer periods of time and involving a greater number of breast cancer survivors .


The most common technique for posterior cruciate ligament ( PCL ) reconstruction is transtibial or tibial inlay .


However , few studies have reported long-term outcome comparisons between the @ techniques .


Tibial inlay PCL reconstruction with patellar tendon autograft will exhibit better clinical and radiographic outcomes than transtibial PCL reconstruction with hamstring autograft .


Cohort study ; Level of evidence , @ .


A total of @ patients ( @ knees ) treated with PCL reconstruction for chronic injuries constituted the study cohort .


Patients were divided into @ groups : transtibial with hamstring ( @ patients ) and tibial inlay with patellar tendon ( @ patients ) .


The mean time from injury to reconstruction was @ months ( range , @-@ months ) , and the mean follow-up was @ months ( range , @-@ months ) .


Outcomes were measured by use of Lysholm knee scores , Tegner activity scores , return to preinjury sports activity , posterior drawer test , laxity test with a Telos device , and development of osteoarthritis .


The preoperative mean Lysholm knee score was @ ( range , @-@ ) in the transtibial group and @ ( range , @-@ ) in the tibial inlay group , improving postoperatively to @ ( range , @-@ ) and @ ( range , @-@ ) , respectively .


The mean Tegner activity scores increased from @ ( range , @-@ ) to @ ( range , @-@ ) in the transtibial group and @ ( range , @-@ ) to @ ( range , @-@ ) in the tibial inlay group .


Twenty-one patients ( @ % ) in the transtibial group and @ patients ( @ % ) in the tibial inlay group were able to return to preinjury sports activity .


In the posterior drawer test , @ patients in the transtibial group and @ patients in the tibial inlay group showed grade II laxity .


The mean side-to-side difference was @ mm ( range , @-@ mm ) in the transtibial group and @ mm ( range , @-@ mm ) in the tibial inlay group , improving postoperatively to @ mm ( range , @-@ mm ) and @ mm ( range , @-@ mm ) , respectively .


There was significant improvement between preoperative and final follow-up values .


However , there were no significant differences between the @ groups in final follow-up outcomes .


Final follow-up radiographs showed that @ patients ( @ % ) in the transtibial group and @ patients ( @ % ) in the tibial inlay group were rated grade C according to International Knee Documentation Committee guidelines .


Clinical and radiographic outcomes between the @ PCL reconstruction techniques were comparable .


Osteoarthritis was observed in patients , with a significant proportion presenting loss of joint space .


Examined factors , excluding meniscectomy , were not correlated with the development of osteoarthritis .


Vitamin D supplementation during pregnancy is a well-accepted recommendation worldwide ; however , the debate about the correct dose is ongoing .


We aimed to compare daily doses of @ , @,@ , and @,@ IU in this randomized , controlled study .


The study group consisted of @ pregnant women aged @-@ years admitted to Kocaeli Maternity and Children Hospital between April @ and April @ .


The participants were randomly divided into @ groups .


@ , @,@ , and @,@ IU/day of vitamin D was supplemented to group @ ( control group , n = @ ) , group @ ( n = @ ) , and group @ ( n = @ ) , respectively .


Serum calcium , @-hydroxyvitamin D ( @OHD ) , and the calcium/creatinine ratio in spot urine samples were measured in the follow-up period .


The serum calcium and @OHD levels of the mothers ' infants were measured as well .


The frequency of vitamin D sufficiency after supplementation was @ % in group @ and it was significantly higher than in groups @ ( @ % ) and @ ( @ % ) ( p = @ ) .


The frequency of vitamin D sufficiency in the infants of the participants was @ % in group @ and it was significantly higher than in groups @ ( @ % ) and @ ( @ % ) ( p = @ ) .


At least @,@ IU/day of vitamin D is needed to ensure adequate vitamin D status in pregnancy and early infancy .


Microvascular obstruction ( MVO ) secondary to ischaemic-reperfusion injury is an important but underappreciated determinant of short - and longer-term outcome following percutaneous coronary intervention ( PCI ) treatment of ST-elevation myocardial infarction ( STEMI ) .


Several small studies have demonstrated a reduction in the degree of MVO utilising a variety of vasoactive agents , with adenosine and sodium nitroprusside ( SNP ) being most evaluated .


However , the evidence base remains weak as the trials have had variable endpoints , differing drug doses and delivery .


As such , the results regarding benefit are conflicting .


The REperfusion Facilitated by LOcal adjunctive therapy in STEMI ( REFLO-STEMI ) trial is a multicentre , prospective , randomised , controlled , open label , study with blinded endpoint analysis : Patients presenting within @ h of onset of STEMI and undergoing planned primary PCI ( P-PCI ) with TIMI @/@ flow in the infarct-related artery ( IRA ) and no significant bystander coronary artery disease on angiography , are randomised into one of three groups : PCI with adjunctive pharmacotherapy ( intracoronary adenosine or SNP ) or control ( standard PCI ) .


All receive Bivalirudin anticoagulation and thrombus aspiration .


The primary outcome is infarct size ( IS ) ( determined as a percentage of total left ventricular mass ) measured by cardiac magnetic resonance imaging ( CMRI ) undertaken at @ to @ h post P-PCI .


Secondary outcome measures include MVO ( hypoenhancement within infarct core ) on CMRI , angiographic markers of microvascular perfusion and MACE during @-month follow-up .


The study aims to recruit @ patients ( powered at @ % to detect a @ % absolute reduction in IS ) .


The REFLO-STEMI study has been designed to address the weaknesses of previous trials , which have collectively failed to demonstrate whether adjunctive pharmacotherapy with adenosine and/or SNP can reduce measures of myocardial injury ( infarct size and MVO ) and improve clinical outcome , despite good basic evidence that they have the potential to attenuate this process .


The REFLO-STEMI study will be the most scientifically robust trial to date evaluating whether adjunctive therapy ( intracoronary adenosine or SNP following thrombus aspiration ) reduces CMRI measured IS and MVO in patients undergoing P-PCI within @ h of onset of STEMI .


To compare the difference in the clinical efficacy on mild and moderate female stress urinary incontinence ( FSUI ) between transcutaneous acupoint electrical stimulation and oral administration of midodrine hydrochloride tablets .


Ninety cases of mild and moderate FSUI were randomized into an observation group and a control group , @ cases in each one .


In the observation group , the transcutaneous acupoint electrical stimulation was applied to Ciliao ( BL @ ) , Shenshu ( BL @ ) , Zigong ( EX-CA @ ) , Guanyuan ( CV @ ) and Qihai ( CV @ ) , once a day .


In the control group , midodrine hydrochloride tablets were prescribed for oral administration , @ mg per treatment , three times each day .


The duration of treatment was @ weeks .


The score of international consultation on incontinence questionnaire-urinary incontinence short form ( ICI-Q-SF ) and leakage of urine in @ h urinal pad test were observed before and after treatment in the patients of the two groups , and the efficacy was compared between the two groups .


The score of ICI-Q-SF and leakage of urine in urinal pad test after treatment were all improved apparently as compared with those before treatment in the two groups ( all P < @ ) , and the results in the observation group were better than those in the control group ( both P < @ ) .


The total effective rate was @ % ( @/@ ) in the observation group , which was better than @ % ( @/@ , P < @ ) in the control group .


The transcutaneous acupoint electrical stimulation achieves the better efficacy on FSUI as compared with the oral administration of midodrine hydrochloride tablets .


This therapy effectively improves the patient 's urine control ability and reduces leakage of urine .


The aim of this study was to examine the level of compliance and persistence in patients with postmenopausal osteoporosis ( OP ) receiving daily risedronate ( @ mg ) with either fixed dosing of three different timing regimens ( A : before breakfast ; B : in-between meals ; C : before bedtime ) or with flexible dosing and the effect on urinary N-terminal telopeptide of Type @ collagen ( NTX-@ ) .


The study included @ patients with postmenopausal OP .


Patients were randomly assigned into six treatment groups each with a permutation of the treatment sequence ( ABC , BCA , etc. ) in the crossover phase ( @ x @ week ) and randomized to @ weeks of either the daily flexible ( either regimen A , B or C ) or fixed timing ( only regimen A , B , or C ) in the patient 's preference phase .


Urinary NTX-@ was tested .


A total of @ patients participated in the patient 's preference phase ( @ % preferred flexible and @ % fixed timing ) .


There was no significant difference between the proportion of responders who were both compliant and persistent in the flexible ( @ % ) and fixed regimens ( @ % ) ( p = @ ) .


A significant difference between the flexible and fixed regimens was seen in persistence in favor of the flexible regimen ( p = @ ) .


There was no significant difference between the flexible and fixed regimens in terms of compliance ( p = @ ) .


Change in urinary NTX-@ did not show any difference between the two regimens .


At the final visit , @ % of patients in the flexible and @ % in the fixed regimen group considered the used risedronate regimen as excellent or very good ( p = @ ) .


A flexible dosing with daily risedronate appears be a valuable option in terms of compliance and persistence for patients with postmenopausal OP .


Treatment of complicated urinary-tract infections is challenging due to rising antimicrobial resistance .


We assessed the efficacy and safety of ceftolozane-tazobactam , a novel antibacterial with Gram-negative activity , in the treatment of patients with complicated lower-urinary-tract infections or pyelonephritis .


ASPECT-cUTI was a randomised , double-blind , double-dummy , non-inferiority trial done in @ centres in @ countries .


Between July , @ , and September , @ , hospital inpatients aged @ years or older who had pyuria and a diagnosis of a complicated lower-urinary-tract infection or pyelonephritis were randomly assigned in a @:@ ratio to receive intravenous @ g ceftolozane-tazobactam every @ h or intravenous high-dose ( @ mg ) levofloxacin once daily for @ days .


The randomisation schedule was computer generated in blocks of four and stratified by study site .


The next allocation was obtained by the study site pharmacist via an interactive voice-response system .


The primary endpoint was a composite of microbiological eradication and clinical cure @-@ days after treatment in the microbiological modified intention-to-treat ( MITT ) population , with a non-inferiority margin of @ % .


This study is registered with ClinicalTrials.gov , numbers NCT@ and NCT@ .


Of @ patients enrolled , @ ( @ % ) , of whom @ ( @ % ) had pyelonephritis , were included in the microbiological MITT population .


Ceftolozane-tazobactam was non-inferior to levofloxacin for composite cure ( @ -LSB- @ % -RSB- of @ vs @ -LSB- @ % -RSB- of @ , @ % CI @-@ ) and , as the lower bound of the two-sided @ % CI around the treatment difference was positive and greater than zero , superiority was indicated .


Adverse event profiles were similar in the two treatment groups and were mainly non-serious .


Treatment with ceftolozane-tazobactam led to better responses than high-dose levofloxacin in patients with complicated lower-urinary-tract infections or pyelonephritis .


The validity of the Talk Test ( TT ) is well documented , but the reliability of the test is not clear .


The aim of this study was to assess the absolute and relative intertester reliability of the TT in cardiac patients .


Cardiac patients ( n = @ ) who had completed an exercise rehabilitation program were consecutively included in the study .


Patients performed a submaximal ramp cycle ergometer test with the TT as intensity indicator .


Every patient was tested twice on the same day by @ different physiotherapists with a break of maximum @ minutes between tests .


Physiotherapists were randomized to tests .


Workload in watts at the first negative stage of the TT was registered as the test result .


Patients and physiotherapists were blinded to test results of the first test .


Absolute reliability of the TT was assessed with Bland-Altman plot , standard error of measurement , and minimal detectable change .


Relative reliability was assessed using the intraclass correlation coefficient ( ICC ) .


Mean difference in peak workload between test and retest was @ W ( @ % CI : -@ to @ ) .


Limit of agreement was estimated to be +@ / -@ W. Standard error of measurement was @ W ( @ % CI : @-@ ) , and minimal detectable change was @ W.


The ICC was @ ( @ % CI : @ to @ ) .


Although the ICC was acceptable , we found a weak absolute intertester reliability of the TT and that the test is an insufficient measure to monitor exercise intensity and safety of cardiac patients when @ or more physiotherapists may be administering the TT .


Advances in information technology ( IT ) now permit population-based preventive screening , but the best methods remain uncertain .


We evaluated whether involving primary care providers ( PCPs ) in a visit-independent population management IT application led to more effective cancer screening .


We conducted a cluster-randomized trial involving @ primary care practice sites and @ PCPs from June @ , @ , to June @ , @ .


Participants included adults eligible for breast , cervical , and/or colorectal cancer screening .


In practices randomized to the intervention group , PCPs reviewed real-time rosters of their patients overdue for screening and provided individualized contact ( via a letter , practice delegate , or patient navigator ) or deferred screening ( temporarily or permanently ) .


In practices randomized to the comparison group , overdue patients were automatically sent reminder letters and transferred to practice delegate lists for follow-up .


Intervention patients without PCP action within @ weeks defaulted to the automated control version .


The primary outcome was adjusted average cancer screening completion rates over @-year follow-up , accounting for clustering by physician or practice .