EUPHRATES ( Evaluating the Use of Polymyxin B Hemoperfusion in a Randomized controlled trial of Adults Treated for Endotoxemia and Septic shock ) is a theragnostic trial ( matching blood measurement to treatment capability ) of PMX hemoperfusion in patients with septic shock and confirmed endotoxemia as measured by the endotoxin activity assay ( EAA ) .


EUPHRATES is a pivotal regulatory trial that is multi-centered , placebo-controlled and blinded .


The trial is being conducted in fifty ICUs in the United States and Canada and is powered to enroll @ patients .


Patients with persistent septic shock despite adequate fluid resuscitation on vasopressors for more than @ and less than @ hours are eligible for measurement of the EAA .


Those with EAA @ are eligible to be randomized to treatment with two sessions of PMX hemoperfusion @ hours apart .


The primary endpoint for the trial is @-day all-cause mortality .


Unique features of the trial include absence of systemic inflammatory response ( SIRS ) criteria as a requirement for inclusion , use of the EAA to confirm endotoxemia as a requisite for treatment , and use of a detailed `` faade '' hemoperfusion event as a blinding mechanism .


The outcomes of the second interim analysis included a resizing of the trial to @ patients and the addition of an exclusion criterion of subjects with multiple organ dysfunction score ( MODS ) @ .


Results are anticipated in @ .


To investigate baseline and concurrent predictors of non-use of illicit heroin among participants randomized to injectable opioids in the North American Opiate Medication Initiative ( NAOMI ) clinical trial .


NAOMI was an open-label randomized controlled trial comparing the effectiveness of injectable diacetylmorphine and hydromorphone for long-term opioid-dependency .


Outcomes were assessed at baseline and during treatment ( @ , @ , @ , @months ) .


Days of non-use of illicit heroin in the prior month at each follow-up visit were divided into three categories : Non-use ; Low use ( @ to @days ) and High use ( @days or more ) .


Tested covariates were : Sociodemographics , Health , Treatment , Drug use and illegal activities .


Mixed-effect proportional odds models with random intercept for longitudinal ordinal outcomes were used to assess the predictors of the non-use of illicit heroin .


@ participants were included in the present analysis .


At each follow-up visit , those with non-use of illicit heroin represented @ % to @ % of the sample .


Fewer days of cocaine use ( p = @ ) , fewer days engaged in illegal activities at baseline ( p < @ ) and at each visit ( p < @ ) , less money spent on drugs ( p < @ ) , days with injection opioid or oral methadone treatment ( p < @ ) and total mg of injectable opioids taken ( p < @ ) , independently predicted lower use of illicit heroin .


The independent effect of several concurrent factors besides the injection of opioid dose suggests benefits from the clinic that go beyond the provision of the medication alone .


Thus , this supervised model of care presents an opportunity to maximize the beneficial impact of medical and psychosocial components of the treatment on improving outcomes associated with non-use of illicit heroin .


The use of videolaryngoscopes is recommended for morbidly obese patients .


The aim of the study was to evaluate the Levitan FPS optical stylet ( Levitan ) vs Lafy-Flex videolaryngoscope ( Lary-Flex ) in a group of MO patients .


Seventy-nine MO ( BMI > @ kg m ( -@ ) ) patients scheduled for bariatric surgery were included in the study and randomly allocated to the Levitan FPS or Lary-Flex group .


The primary endpoint was time to intubation and evaluation laryngoscopic of glottic view .


Anesthesiologists were asked to evaluate the glottic view first under direct laryngoscopy using the videolaryngoscope as a standard laryngoscope ( monitor display was excluded from use ) and then using devices .


The secondary endpoint was the cardiovascular response to intubation and the participant 's evaluation of such devices .


The time to intubation was @ sec .


versus @ sec .


for Levitan and Lary-Flex , respectively ( P < @ ) .


In all cases of CL grade > @ under direct laryngoscopy , the study devices improved CL grade to @ .


The Levitan FPS produced a greater cardiovascular response than the Lary-Flex videolaryngoscope .


The Lary-Flex videolaryngoscope and the Levitan FPS optical stylet improve the laryngeal visualization in morbidly obese patients , allowing for fast endotracheal intubation , but Lary-Flex produces less cardiovascular response to intubation attempt .


The aim of the present randomized , double-blind , placebo-controlled clinical trial was to assess the efficacy and tolerability of @ % indomethacin ( INDOM ) eye drops in adult patients suffering from macular edema ( ME ) related to different etiology uveitis .


Forty-six eyes of @ adult patients ( @ females and @ males ) mean age @ years , affected by inflammatory ME , were randomized to receive a dose of commercial @ % INDOM eye-drops four times per day ( @ subjects = @ eyes ) or placebo ( the vehicle of INDOM , @ subjects = @ eyes ) during a @-month active therapy follow-up .


Study assessment at each visit included visual acuity testing ( VA ) , slit-lamp examination , IOP evaluation , and Heidelberg Spectralis optical coherence tomography ( OCT ) central foveal thickness ( CFT ) measurement .


Any variation in subjective symptoms and tolerability was also detected .


Statistical analysis showed , from baseline to the @-month visit , a significant reduction in CFT ( P < @ ) and a significant improvement in VA only in the @ % INDOM-treated group ; a global reduction of discomfort symptoms was present in both groups ( P < @ ) .


The four times per day administration of @ % INDOM eye drops in eyes affected with uveitic ME from different etiologies , compared with placebo , is associated with a significant reduction in ME at the @-month follow-up visit , as measured by spectral-domain optical coherence tomography ( SD-OCT ) .


However , not all eyes showed a complete resolution of ME because of vitreoretinal traction .


( https://eudract.ema.europa.eu/index.html number , EUDRACT @-@-@ . )


To assess the effect and safety of moderate-to-vigorous resistance exercise during pregnancy .


Randomized controlled study .


Two antenatal clinics in Gothenburg , Sweden .


Ninety-two healthy pregnant women .


The intervention was administered during gestational weeks @-@ .


The intervention group received supervised resistance exercise twice a week , performed at an activity level equivalent to within moderate-to-vigorous ( n = @ ) .


The control group received generalized exercise recommendation , a home-based training program and a telephone follow up ( n = @ ) .


Health-related quality of life , physical strength , pain , weight , blood pressure , functional status , activity level , and perinatal data .


Functional status deteriorated during the intervention in both groups and pain increased .


Significant differences between the groups were obtained only for birthweight .


Newborns delivered by women who underwent resistance exercise during pregnancy were significantly heavier than those born to control women ; @ ( @ ) g vs. @ ( @ ) g ( p = @ ) , a difference that disappeared when adjustment was made for gestational age ( p = @ ) .


Both groups showed normal health-related quality of life , blood pressure , and perinatal data .


These findings indicate that supervised , moderate-to-vigorous resistance exercise does not jeopardize the health status of healthy pregnant women or the fetus during pregnancy , but instead appears to be an appropriate form of exercise in healthy pregnancy .


The interleukin ( IL ) -@ / tumor necrosis factor ( TNF ) a pathway is supposed to play a key role in the amplification of the immune response in chronic obstructive pulmonary disease ( COPD ) inflammation .


Inhaled corticosteroids ( ICS ) in combination with long-acting @-agonists ( LABA ) have shown airway anti-inflammatory effects in recent studies , but the mechanism is still uncertain .


Patients were treated in a randomized , open-labeled , parallel group clinical trial with either a combination of salmeterol xinafoate/fluticasone propionate ( SF ; Seretide , GlaxoSmithKline ) Diskus ( @/@ g twice daily ) or ipratropium bromide/salbutamol ( IS ; Combivent , Boehringer Ingelheim ) MDI ( @ g/@ g quartic daily ) for @ weeks .


At the start and the end of treatment , induced sputum was collected and the concentration of IL-@ and TNF - , the number of neutrophils and eosinophils were measured .


Following @ weeks of treatment , a statistically significant fall from baseline in the concentration of TNF - in sputum ( P = @ ) was seen after treatment with SF but not with IS .


However , neither treatment had significant effects on the concentration of IL-@ in sputum .


There was a decrease from baseline in the number of sputum neutrophils with SF that approached statistical significance ( P = @ ) but not with IS , while the number of sputum eosinophils did not change significantly from baseline in either treatment group .


There was a statistically significant decline from baseline in the quality of life as assessed by the St George 's respiratory questionnaire in both the SF ( P = @ ) and IS ( P = @ ) treatment groups , but no evidence of improvement in lung function was observed in either group .


The sputum TNF - and neutrophils , but not IL-@ and macrophages , could be reduced by ICS/LABA treatment , suggesting that IL-@ could be involved in the corticosteroid resistance of COPD inflammation .


Treatment of Preserved Cardiac Function Heart Failure With an Aldosterone Antagonist ( TOPCAT ) patients with heart failure and preserved left ventricular ejection fraction assigned to spironolactone did not achieve a significant reduction in the primary composite outcome ( time to cardiovascular death , aborted cardiac arrest , or hospitalization for management of heart failure ) compared with patients receiving placebo .


In a post hoc analysis , an @-fold difference was identified in this composite event rate between the @ patients randomized from Russia and Georgia compared with the @ enrolled from the United States , Canada , Brazil , and Argentina ( the Americas ) .


To better understand this regional difference in clinical outcomes , demographic characteristics of these populations and their responses to spironolactone were explored .


Patients from Russia/Georgia were younger , had less atrial fibrillation and diabetes mellitus , but were more likely to have had prior myocardial infarction or a hospitalization for heart failure .


Russia/Georgia patients also had lower left ventricular ejection fraction and creatinine but higher diastolic blood pressure ( all P < @ ) .


Hyperkalemia and doubling of creatinine were more likely and hypokalemia was less likely in patients receiving spironolactone in the Americas with no significant treatment effects in Russia/Georgia .


All clinical event rates were markedly lower in Russia/Georgia , and there was no detectable impact of spironolactone on any outcomes .


In contrast , in the Americas , the rates of the primary outcome , cardiovascular death , and hospitalization for heart failure were significantly reduced by spironolactone .


This post hoc analysis demonstrated greater potassium and creatinine changes and possible clinical benefits with spironolactone in patients with heart failure and preserved ejection fraction from the Americas .


The relationship between low back pain ( LBP ) and the lifting/carrying of loads is still a matter of great discussion .


In teenagers , the weight of the school bag has been considered to play a pathogenic role in LBP but the relationship between the actual weight of the school bag and LBP symptoms does not seem to be a straightforward one .


Numerous factors have been identified that influence the perception of weight .


This study aimed to evaluate the influence of low back pain and the type of container on the perception of load heaviness by healthy teenagers .


A convenience sample of @ healthy teenage males ( mean SD age @ @ years ) was recruited from the members of two local sports clubs .


The volunteers were evaluated during one of their training sessions .


Information about a history of consequential LBP was gathered by questionnaire .


Subjects were invited to estimate the weight of three bags ( a typical school bag , a sports bag with the logo of a well-known brand , and a neutral bag ) containing two different loads ( total weights approximately @ and @ kg ) .


Consequential LBP ( i.e. , LBP requiring medical attention and/or interfering with usual sports activities ) was reported by @ % of them .


The majority of the LBP episodes occurred @ months before the tests .


Overall , teenagers significantly ( p @ ) underestimated the weight of the sports bag compared with the school bag and the neutral bag .


Compared with those with no LBP , subjects with a history of LBP overestimated the weight of the heavier load .


Our results suggest that several subjective variables significantly influence the perception of load heaviness .


Until we have a better understanding of the mechanical role of the backpack weight versus the perception of its weight in the aetiology of LBP , any recommendations about the schoolbag weight limit should be viewed with caution .


Abdominal Cesarean sections ( C-sections ) are frequently associated with an increased risk of excessive or unpleasant scarring .


A topical scar gel containing extract of Allium cepae , allantoin and heparin ( Contractubex ; Merz Pharmaceuticals GmbH , Germany ) , has shown efficacy in improving the appearance of various scar types .


To investigate the efficacy of the topical scar gel , Contractubex , in the early treatment of C-section scars .


A total of @ females , aged @ years , who had given birth by elective C-section for the first time within the last @-@ days , were included in this prospective , randomized , single-center study .


Patients were advised to apply the topical scar gel twice daily ( treatment group ) , or received no treatment ( control group ) .


Efficacy was evaluated at @ and @ weeks after a baseline visit using the Patient and Observer Scar Assessment Scale ( POSAS ) , a validated scar assessment tool comprised of a Patient Scale and an Observer Scale .


Analysis revealed a significant change in the POSAS Patient Scale total score , with a @ % improvement in the treatment group compared with a decline of similar magnitude ( -@ % ) in the control group at week @ .


Significant improvements were also seen for POSAS Patient Scale sub-items in the treatment group compared with the control group for scar color ( @ % vs -@ % , respectively , P = @ ) , stiffness ( @ % vs -@ % , respectively , P = @ ) , and irregularity ( @ % vs -@ % , respectively , P = @ ) after @ weeks of treatment .


No significant changes were observed for the POSAS Observer Scale total score or its subitems after treatment with the topical scar gel , although there was a strong overall trend in favor of the treatment group .


No significant adverse events were observed during the study .


Contractubex represents an efficacious and well-tolerated preventative treatment that rapidly and significantly improves the color , stiffness and irregularity of C-section scars .


Existing treatments for postherpetic neuralgia , and for neuropathic pain in general , are limited by modest efficacy and unfavourable side-effects .


The angiotensin II type @ receptor ( AT@R ) is a new target for neuropathic pain .


EMA@ , a highly selective AT@R antagonist , is under development as a novel neuropathic pain therapeutic agent .


We assessed the therapeutic potential of EMA@ in patients with postherpetic neuralgia .


In this multicentre , placebo-controlled , double-blind , randomised , phase @ clinical trial , we enrolled patients ( aged @-@ years ) with postherpetic neuralgia of at least @ months ' duration from @ centres across six countries .


We randomly allocated @ participants to receive either oral EMA@ ( @ mg twice daily ) or placebo for @ days .


Randomisation was done according to a centralised randomisation schedule , blocked by study site , which was generated by an independent , unmasked statistician .


Patients and staff at each site were masked to treatment assignment .


We assessed the efficacy , safety , and pharmacokinetics of EMA@ .


The primary efficacy endpoint was change in mean pain intensity between baseline and the last week of dosing ( days @-@ ) , measured on an @-point numerical rating scale .


The primary efficacy analysis was intention to treat .


This trial is registered with the Australian New Zealand Clinical Trials Registry , number ACTRN@ .


@ patients were assigned to EMA@ and @ were assigned to placebo .


The patients given EMA@ reported significantly less pain compared with baseline values in the final week of treatment than did those given placebo ( mean reductions in pain scores -@ -LSB- SD @ -RSB- vs -@ -LSB- @ -RSB- ; difference of adjusted least square means -@ -LSB- SE @ -RSB- ; @ % CI -@ to -@ ; p = @ ) .


No serious adverse events related to EMA@ occurred .


Overall , @ patients reported @ treatment-emergent adverse events in the EMA@ group compared with @ such events reported by @ patients given placebo .


EMA@ ( @ mg twice daily ) provides superior relief of postherpetic neuralgia compared with placebo at the end of @ days of treatment .


EMA@ was well tolerated by patients .


It is not clear whether newly introduced cordless displacement systems are better able to manage gingiva than conventional systems .


The purpose of this invivo study was to evaluate the gingival management ability of @ different displacement methods with a standardized subgingival preparation finish line .


The effects of @ displacement techniques on gingival management and impression quality were evaluated by means of @ evaluation criteria .


A subgingival preparation finish line of between @ and @ mm was ensured , andthe buccal aspects of @ ( n = @ ) teeth were clinically assessed for ease of application , time spent , bleeding , remnants , and dilatation .


The complete reproduction of the preparation finish line and the bubble and void formations on polyether impressions were also evaluated .


The data were statistically analyzed with the ( @ ) test ( = @ ) .


The Bonferroni correction was used to control Type I error for the pairwise comparison groups ( = @ ) .


Statistically significant differences were found for all criteria among the groups ( P < @ ) .


The nonimpregnated displacement cord group was the least effective group in terms of bleeding and impression quality ( P < @ ) .


The aluminum chloride impregnated cord group and the displacement paste with cap group were found to be comparable in terms of remnants , dilatation , and impression quality ( P > @ ) .


The retraction cap with paste group showed better results for ease of application , time spent , and bleeding than the aluminum chloride impregnated cord group ( P < @ ) .


Although the group with aluminum chloride impregnated cord , displacement paste , and cap showed better results for dilatation , it was time consuming and difficult ( P < @ ) .


Except for the nonimpregnated cord group , all of the groups were comparable and clinically useful , with perfect or acceptable impression qualities .


Osteoarthritis is the most prevalent joint disease and a common cause of joint pain , functional loss , and disability .


Conventional treatments demonstrate only modest clinical benefits without lesion reversal .


Autologous mesenchymal stromal cell ( MSC ) treatments have shown feasibility , safety , and strong indications for clinical efficacy .


We performed a randomized , active control trial to assess the feasibility and safety of treating osteoarthritis with allogeneic MSCs , and we obtain information regarding the efficacy of this treatment .


We randomized @ patients with chronic knee pain unresponsive to conservative treatments and showing radiological evidence of osteoarthritis into @ groups of @ patients .


The test group was treated with allogeneic bone marrow MSCs by intra-articular injection of @ @ ( @ ) cells .


The control group received intra-articular hyaluronic acid ( @ mg , single dose ) .


Clinical outcomes were followed for @ year and included evaluations of pain , disability , and quality of life .


Articular cartilage quality was assessed by quantitative magnetic resonance imaging T@ mapping .


Feasibility and safety were confirmed and indications of clinical efficacy were identified .


The MSC-treated patients displayed significant improvement in algofunctional indices versus the active controls treated with hyaluronic acid .


Quantification of cartilage quality by T@ relaxation measurements showed a significant decrease in poor cartilage areas , with cartilage quality improvements in MSC-treated patients .


Allogeneic MSC therapy may be a valid alternative for the treatment of chronic knee osteoarthritis that is more logistically convenient than autologous MSC treatment .


The intervention is simple , does not require surgery , provides pain relief , and significantly improves cartilage quality .


We aimed to evaluate treatment responses to atazanavir plus ritonavir ( ATV/r ) or efavirenz ( EFV ) in initial antiretroviral regimens among women and men , and determine if treatment outcomes differ by sex .


We performed a randomized trial of open-label ATV/r or EFV combined with abacavir/lamivudine ( ABC/@TC ) or tenofovir/emtricitabine ( TDF/FTC ) in @ human immunodeficiency virus type @-infected , treatment-naive persons enrolled between September @ and November @ at @ sites in the United States and Puerto Rico .


Associations of sex with @ primary study endpoints of time to virologic failure , safety , and tolerability events were analyzed using Cox proportional hazards models .


Model-based population pharmacokinetic analysis was performed using nonlinear mixed effects modeling ( NONMEM version VII ) .


Of @ participants , @ were women .


Women assigned to ATV/r had a higher risk of virologic failure with either nucleoside reverse transcriptase inhibitor backbone than women assigned to EFV , or men assigned to ATV/r .


The effects of ATV/r and EFV upon safety and tolerability risk did not differ significantly by sex .


With ABC/@TC , women had a significantly higher ( @ % ) safety risk compared to men ; with TDF/FTC , the safety risk was @ % larger for women compared to men , but not statistically significant .


Women had slower ATV clearance and higher predose levels of ATV compared to men .


Self-reported adherence did not differ significantly by sex .


This is the first randomized clinical trial to identify a significantly earlier time to virologic failure in women randomized to ATV/r compared to women randomized to EFV .


This finding has important clinical implications given that boosted protease inhibitors are often favored over EFV in women of childbearing potential .


This study investigated strategies that may increase the yield of drug resistance testing prior to starting antiretroviral therapy ( ART ) , and whether transmitted and polymorphic resistance-associated mutations ( RAMs ) correlated with virological outcomes .


We carried out retrospective testing of baseline samples from patients entering the SENSE trial of first-line ART in Europe , Russia and Israel .


Prior to randomization to etravirine or efavirenz plus two nucleos ( t ) ide reverse transcriptase inhibitors ( NRTIs ) , plasma samples underwent routine Sanger sequencing of HIV-@ RT and protease ( ( plasma ) SS ) in order to exclude patients with transmitted RAMs .


Retrospectively , Sanger sequencing was repeated with HIV-@ DNA from baseline peripheral blood mononuclear cells ( PBMCSS ) ; baseline plasma samples were retested by allele-specific PCR targeting seven RT RAMs ( AS-PCR ) and ultra-deep RT sequencing ( UDS ) .


By ( plasma ) SS , @/@ ( @ % ) patients showed @ transmitted RAM affecting the NRTIs ( @/@ , @ % ) , non-nucleoside reverse transcriptase inhibitors ( @/@ , @ % ) or protease inhibitors ( @/@ , @ % ) .


No additional RAMs were detected by AS-PCR ( n = @ ) and UDS ( n = @ ) ; PBMCSS ( n = @ ) yielded two additional samples with one RAM each .


Over @ weeks , @/@ ( @ % ) patients on etravirine and @/@ ( @ % ) on efavirenz experienced virological failure ; none had baseline RAMs .


Conversely , @/@ ( @ % ) patients randomized to etravirine had one polymorphic RAM from the etravirine score in baseline plasma ( V@I , V@I or E@A ) , without any impact on virological outcomes .


The detection of resistance increased marginally with PBMC testing but did not increase with sensitive plasma testing .


A careful consideration is required of the cost-effectiveness of different strategies for baseline HIV drug resistance testing .


This study aims to confirm the factor structure of the Menopause-Specific Quality of Life ( MENQOL ) questionnaire by using confirmatory factor analysis ( CFA ) and to determine whether improvements in menopause-specific health-related quality of life ( HRQOL ) observed with bazedoxifene ( BZA ) / conjugated estrogens ( CE ) relative to placebo are clinically meaningful .


Postmenopausal women with seven or more moderate to severe hot flushes per day ( or @ per wk ) received BZA @ mg/CE @ mg , BZA @ mg/CE @ mg , or placebo for @ weeks .


HRQOL and treatment satisfaction were evaluated using the MENQOL questionnaire and the Menopause Symptoms Treatment Satisfaction Questionnaire , respectively .


The structure of the MENQOL questionnaire was evaluated using CFA .


To estimate clinically important differences ( CIDs ) in HRQOL , we used a repeated-measures model to estimate changes in MENQOL domain and total scores using Menopause Symptoms Treatment Satisfaction Questionnaire items as anchors .


The CFA model fits the MENQOL data ( Bentler 's comparative fit index > @ ) .


CID estimates ranged from @ to @ for the MENQOL domains and total score .


Change from baseline in MENQOL vasomotor domain score for BZA @ mg/CE @ mg and BZA @ mg/CE @ mg compared with placebo was greater than the estimated CID , as were changes in MENQOL physical domain and total scores for BZA @ mg/CE @ mg compared with placebo .


CFA confirms the factor structure of the MENQOL questionnaire .


Treatment with BZA/CE provides clinically meaningful improvements in HRQOL in a population of postmenopausal women with bothersome vasomotor symptoms .


In schizophrenia , the ability to adaptively infer the thoughts and feelings of others ( i.e. , social cognition ) is strongly associated with community functioning .


Researchers have designed psychosocial interventions to improve social cognition with the aim of improving downstream social functioning .


Social Cognition and Interaction Training ( SCIT ) is one such intervention .


Previous research on SCIT has been promising , but has consisted largely of smaller trials with insufficient experimental control .


Randomized , controlled trial .


The current article reports on a controlled trial of @ adults with schizophrenia randomized to receive either SCIT ( n = @ ) , delivered in weekly group sessions , or treatment as usual ( n = @ ) for @ months .


Participants completed assessments of social cognition , social functioning , neurocognition and symptoms at baseline , post-treatment , and @-month follow-up .


Primary analyses suggest that SCIT may improve social functioning , negative symptoms , and possibly hostile attributional bias .


Post-hoc analyses suggest a dose-response effect .


Findings are discussed in the context of continuing to refine and improve social cognitive interventions for schizophrenia .


Social cognitive intervention is a feasible and promising approach to improving social functioning among individuals with schizophrenia-spectrum disorders .


Dose-response findings suggest that delivering social cognitive interventions with greater frequency may maximize their benefit to patients .


Research on social cognitive interventions is still young and effects from well-controlled trials have been inconsistent .


It is not yet clear which components of social cognitive training may be the key active ingredients .


In the treatment of atopic dermatitis , pimecrolimus has high antipruritic effects .


To investigate the efficacy of @ % pimecrolimus cream in comparison to @ % hydrocortisone cream in non-atopic prurigo nodularis ( PN ) .


A randomized , controlled , double-blind study with intraindividual randomization was done in @ patients ( @ females , @ males ; mean age @ years ) with PN .


Pruritus intensity decreased significantly ( p < @ ) on both treated sides as early as after @ days of treatment ; scratch lesions improved ( p < @ ) .


Quality of life as assessed by the Dermatology Life Quality Index improved significantly .


However , a significant advantage of pimecrolimus over hydrocortisone was not found .


The results suggest that the non-steroid pimecrolimus is an effective alternative for PN treatment .


The objective was to assess the feasibility and acceptability of nine positive psychology exercises delivered to patients hospitalized for suicidal thoughts or behaviors , and to secondarily explore the relative impact of the exercises .


Participants admitted to a psychiatric unit for suicidal ideation or behavior completed daily positive psychology exercises while hospitalized .


Likert-scale ratings of efficacy ( optimism , hopelessness , perceived utility ) and ease of completion were consolidated and compared across exercises using mixed models accounting for age , missing data and exercise order .


Overall effects of exercise on efficacy and ease were also examined using mixed models .


Fifty-two ( @ % ) of @ participants completed at least one exercise , and @/@ ( @ % ) assigned exercises were completed .


There were overall effects of exercise on efficacy ( ( @ ) = @ ; P = @ ) but not ease of completion ( ( @ ) = @ ; P = @ ) , accounting for age , order and skipped exercises .


Effect ( Cohen 's d ) of exercise on both optimism and hopelessness was moderate for the majority of exercises .


Exercises related to gratitude and personal strengths ranked highest .


Both gratitude exercises had efficacy scores that were significantly ( P = @ ) greater than the lowest-ranked exercise ( forgiveness ) .


In this exploratory project , positive psychology exercises delivered to suicidal inpatients were feasible and associated with short-term gains in clinically relevant outcomes .


To evaluate the efficacy and safety of the selective sodium glucose co-transporter @ inhibitor dapagliflozin in Japanese patients with type @ diabetes mellitus ( T@DM ) inadequately controlled by diet and exercise .


Patients received placebo or dapagliflozin ( @ or @ mg ) once daily for @ weeks .


The primary outcome measure was change from baseline in glycated haemoglobin ( HbA@c ) .


Patients ( N = @ ) had modestly elevated baseline HbA@c ( mean @ % ) and most had mild or moderate renal impairment ( estimated glomerular filtration rate range @-@ ml/min/@ @ m ( @ ) ) .


Greater reductions in mean HbA@c level were observed with dapagliflozin ( @ mg , -@ % ; @ mg , -@ % ) than with placebo ( -@ % ) at week @ and these were greater in patients with higher baseline HbA@c levels .


Fasting plasma glucose ( FPG ) was also significantly reduced with dapagliflozin ( @ mg , -@ mg/dl ; @ mg , -@ mg/dl ) compared with placebo ( +@ mg/dl ) .


Dapagliflozin significantly reduced body weight ( @ mg , -@ kg ; @ mg , -@ kg ) compared with placebo ( -@ kg ) .


Overall , @ and @ % of patients with dapagliflozin @ and @ mg , respectively , and @ % with placebo experienced @ adverse event , mostly mild or moderate , and unrelated to study treatment .


Two patients on dapagliflozin @ mg reported hypoglycaemia .


Four patients across all groups reported events suggestive of genital infection and four of urinary tract infection .


No events of pyelonephritis were reported .


Dapagliflozin ( @ and @ mg ) was well tolerated and effective in reducing HbA@c , FPG and body weight over @ weeks in Japanese patients with T@DM inadequately controlled by diet and exercise .


The Clopidogrel in High-risk patients with Acute Non-disabling Cerebrovascular Events ( CHANCE ) trial showed that the combined treatment of clopidogrel and aspirin decreases the @-day risk of stroke without increasing hemorrhage in comparison with aspirin alone , but provided insufficient data to establish whether the benefit persisted over a longer period of time beyond the trial termination .


We report the @-year follow-up outcomes of this trial .


The trial was a randomized , double-blind , placebo-controlled trial conducted at @ centers in China .


We randomly assigned @ patients within @ hours after onset of minor stroke or high-risk transient ischemic attack to clopidogrel-aspirin therapy ( loading dose of @ mg of clopidogrel on day @ , followed by @ mg of clopidogrel per day for @ days , plus @ mg of aspirin per day for the first @ days ) or to the aspirin-alone group ( @ mg/d for @ days ) .


The primary outcome was stroke event ( ischemic or hemorrhagic ) during @-year follow-up .


Differences in outcomes between groups were assessed by using the Cox proportional hazards model .


Stroke occurred in @ ( @ % ) patients in the clopidogrel-aspirin group , in comparison with @ ( @ % ) patients in the aspirin group ( hazard ratio , @ ; @ % confidence interval , @-@ @ ; P = @ ) .


Moderate or severe hemorrhage occurred in @ ( @ % ) patients in the clopidogrel-aspirin group and in @ ( @ % ) patients in the aspirin group ( P = @ ) .


The early benefit of clopidogrel-aspirin treatment in reducing the risk of subsequent stroke persisted for the duration of @-year of follow-up .


Schizophrenia ( SZ ) is a chronic illness that is treated symptomatically .


Cognitive dysfunction is a core feature of SZ that is relatively intractable to pharmacotherapy .


Yoga can improve cognitive function among healthy individuals .


A recent open trial indicated significant benefits of yoga training ( YT ) in conjunction with conventional pharmacotherapy among patients with SZ .


To describe the protocol for an ongoing randomised controlled trial designed to test whether the reported beneficial effects of YT on cognitive function among SZ patients can be replicated .


Secondarily , the effects of YT on daily functioning living skills are evaluated .


Consenting patients with SZ receive routine clinical treatment and are randomised to adjunctive YT , adjunctive physical exercise ( PE ) or treatment as usual ( proposed N = @ total , N = @ in each group ) .


The trial involves YT or PE @ days a week and lasts @ weeks .


Participants are evaluated thrice over @ months .


Cognitive functions measured by Trail Making Test , University of Pennsylvania Neurocognitive Computerised Battery were primary outcome measures while clinical severity and daily functioning measured by Independent Living Skills Survey were secondary outcome measures .


A total of @ participants have been randomised as of @ August @ , which exceeded beyond @ proposed after attrition .


Once participants begin YT or PE they generally complete the protocol .


No injuries have been reported .


Short term YT is feasible and acceptable to Indian SZ patients .


If beneficial effects of YT are detected , it will provide a novel adjunctive cognitive remediation strategy for SZ patients .


To evaluate the efficacy and safety of intravitreal injections of pegaptanib sodium in subjects with diabetic macular edema ( DME ) .


There were @ subjects with DME who were randomized to receive , every @ weeks , either an intravitreal injection of pegaptanib sodium or a sham injection .


The study was double-masked for the first @ weeks , and then an open label phase continued to week @ .


The primary efficacy endpoint was evaluated at week @ , and safety was assessed throughout the @ weeks .


The proportion of subjects who experienced more than @ letters improvement of visual acuity in ETDRS chart from baseline to week @ was statistically significantly greater ( p-value = @ ) in the pegaptanib sodium group , @ % , than in the sham group , @ % .


The incidence of treatment-related adverse events was similar between the treatment groups ( pegaptanib sodium group : @ % , sham group : @ % ) .


The reported adverse events were mainly mild or moderate ophthalmic events and related to the injection procedure .


During open-label phase up to @ weeks , no new safety concerns were identified compared with the double-masked phase .


However , in light of the issue concerning proper maintenance of masking of the study treatments , the study was not considered as a well-controlled , double-masked study .


More than @,@ total knee replacements are performed annually in the United States ; however , high-quality evidence to support the effectiveness of the procedure , as compared with nonsurgical interventions , is lacking .


In this randomized , controlled trial , we enrolled @ patients with moderate-to-severe knee osteoarthritis who were eligible for unilateral total knee replacement .


Patients were randomly assigned to undergo total knee replacement followed by @ weeks of nonsurgical treatment ( total-knee-replacement group ) or to receive only the @ weeks of nonsurgical treatment ( nonsurgical-treatment group ) , which was delivered by physiotherapists and dietitians and consisted of exercise , education , dietary advice , use of insoles , and pain medication .


The primary outcome was the change from baseline to @ months in the mean score on four Knee Injury and Osteoarthritis Outcome Score subscales , covering pain , symptoms , activities of daily living , and quality of life ( KOOS@ ) ; scores range from @ ( worst ) to @ ( best ) .


A total of @ patients completed the @-month follow-up assessment .


In the nonsurgical-treatment group , @ patients ( @ % ) underwent total knee replacement before the @-month follow-up ; in the total-knee-replacement group , @ patient ( @ % ) received only nonsurgical treatment .


In the intention-to-treat analysis , the total-knee-replacement group had greater improvement in the KOOS@ score than did the nonsurgical-treatment group ( @ vs. @ ; adjusted mean difference , @ -LSB- @ % confidence interval , @ to @ -RSB- ) .


The total-knee-replacement group had a higher number of serious adverse events than did the nonsurgical-treatment group ( @ vs. @ , P = @ ) .


In patients with knee osteoarthritis who were eligible for unilateral total knee replacement , treatment with total knee replacement followed by nonsurgical treatment resulted in greater pain relief and functional improvement after @ months than did nonsurgical treatment alone .


However , total knee replacement was associated with a higher number of serious adverse events than was nonsurgical treatment , and most patients who were assigned to receive nonsurgical treatment alone did not undergo total knee replacement before the @-month follow-up .


( Funded by the Obel Family Foundation and others ; MEDIC ClinicalTrials.gov number , NCT@ . )


It is not known whether high-risk plaque , as detected by coronary computed tomography angiography ( CTA ) , permits improved early diagnosis of acute coronary syndromes ( ACS ) independently to the presence of significant coronary artery disease ( CAD ) in patients with acute chest pain .


The primary aim of this study was to determine whether high-risk plaque features , as detected by CTA in the emergency department ( ED ) , may improve diagnostic certainty of ACS independently and incrementally to the presence of significant CAD and clinical risk assessment in patients with acute chest pain but without objective evidence of myocardial ischemia or myocardial infarction ( MI ) .


We included patients randomized to the coronary CTA arm of the ROMICAT-II ( Rule Out Myocardial Infarction/Ischemia Using Computer-Assisted Tomography II ) trial .


Readers assessed coronary CTA qualitatively for the presence of nonobstructive CAD ( @ % to @ % stenosis ) , significant CAD ( @ % or @ % stenosis ) , and the presence of at least @ of the high-risk plaque features ( positive remodeling , low < @ Hounsfield units plaque , napkin-ring sign , spotty calcium ) .


In logistic regression analysis , we determined the association of high-risk plaque with ACS ( MI or unstable angina pectoris ) during the index hospitalization and whether this was independent of significant CAD and clinical risk assessment .


Overall , @ of @ patients who underwent coronary CTA with diagnostic image quality ( mean age @ @ years ; @ % men ) had ACS ( @ % ; MI n = @ ; unstable angina pectoris n = @ ) .


CAD was present in @ patients ( @ % ; nonobstructive CAD in @ patients -LSB- @ % -RSB- and significant CAD with @ % stenosis in @ patients -LSB- @ % -RSB- ) .


High-risk plaques were more frequent in patients with ACS and remained a significant predictor of ACS ( odds ratio -LSB- OR -RSB- : @ ; @ % CI : @ to @ ; p = @ ) after adjustment for @ % stenosis ( OR : @ ; @ % CI : @ to @ ; p < @ ) and clinical risk assessment ( age , sex , number of cardiovascular risk factors ) .


Similar results were observed after adjustment for @ % stenosis .


In patients presenting to the ED with acute chest pain but negative initial electrocardiogram and troponin , presence of high-risk plaques on coronary CTA increased the likelihood of ACS independent of significant CAD and clinical risk assessment ( age , sex , and number of cardiovascular risk factors ) .


( Multicenter Study to Rule Out Myocardial Infarction by Cardiac Computed Tomography -LSB- ROMICAT-II -RSB- ; NCT@ ) .


Impaired arousal from sleep has been implicated in sudden infant death syndrome ( SIDS ) .


Sleeping in the prone position is a major risk factor for SIDS .


Epidemiological studies have shown that pacifier use decreases the risk of SIDS , even when infants sleep prone .


We examined spontaneous arousability in infants slept prone and supine over the first @ months of life and hypothesised that spontaneous arousals would be increased in pacifier users , particularly in the prone position .


Healthy term infants ( n = @ ) were studied on three occasions over the first @ months after birth .


Spontaneous cortical arousals and subcortical activations were scored and converted into frequency per hour of sleep .


There was no effect of pacifier use on total time spent sleeping or awake or the number of spontaneous awakenings at any age .


There was also no effect of pacifier use on the frequency or duration of the total number of spontaneous arousals or on cortical arousals and subcortical activations .


Pacifier use did not alter infant spontaneous arousability at any of the three ages studied , in either the prone or supine sleeping position .


Any preventative effect of pacifiers for SIDS may be through physiological mechanisms other than increased arousability .


Restorative home care services are short-term and aimed at maximizing a person 's ability to live independently .


They are multidimensional and often include an exercise program to improve strength , mobility , and balance .


The aim of this study was to determine whether a lifestyle exercise program would be undertaken more often and result in greater functional gains than the current structured exercise program delivered as part of a restorative home care service for older adults .


A pragmatic randomized controlled trial was conducted in an organization with an established restorative home care service .


Individuals who were to have an exercise program as part of their service were randomized to receive either a lifestyle and functional exercise program called LiFE ( as this was a new program , the intervention ) or the structured exercise program currently being used in the service ( control ) .


Exercise data collected by the individuals throughout and pre and post intervention testing was used to measure balance , strength , mobility , falls efficacy , vitality , function , and disability .


There was no difference between the groups in the amounts of exercise undertaken during the @-week intervention period .


Outcome measurement indicated that the LiFE program was as effective , and on @ % of the measures , more effective , than the structured exercise program .


Organizations delivering restorative home care services that include an exercise component should consider whether LiFE rather than the exercise program they are currently using could help their clients achieve better outcomes .


Despite the life threatening nature of an HIV diagnosis and the multidimensional problems experienced by this patient population during antiretroviral therapy , the effectiveness of a palliative care approach for HIV positive patients on ART is as yet unknown .


A randomised controlled trial ( RCT ) was conducted in a sample of @ HIV positive patients on ART in an urban clinic in Mombasa , Kenya .


The intervention was a minimum of seven sessions of multidimensional , person-centred care , given by HIV nurses trained in the palliative care approach over a period of @months .


Rates of recruitment and refusal , the effectiveness of the randomisation procedure , trial follow-up and attrition and extent of missing data are reported @ patients ( @ randomised to control arm , @ randomised to intervention arm ) were recruited over @ months , with a refusal rate of @ % .


During the study period , three participants died from cancer , three withdrew ( two moved away and one withdrew due to time constraints ) .


All of these patients were in the intervention arm : details are reported .


There were five additional missing monthly interviews in both the control and intervention study arm , bringing the total of missing data to @ data points ( @ % ) .


The quality and implications of these data are discussed extensively and openly , including the effect of full and ethical consent procedures , respondent burden , HIV stigma , accurate randomisation , patient safety and the impact of the intervention .


Data on recruitment randomisation , attrition and missing data in clinical trials should be routinely reported , in conjunction with the now established practice of publishing study protocols to enhance research integrity , transparency and quality .


Transparency is especially important in cross cultural settings , in which the sources of funding and trial design are often not based in the country of data collection .


Findings reported can be used to inform future RCTs in this area .


To evaluate the efficacy of inducing labour using a double-balloon catheter and oral misoprostol sequentially , in comparison with oral misoprostol alone .


A multicentre randomised controlled trial .


Five hospitals in Germany .


A total of @ pregnant women with an unfavourable cervix undergoing labour induction at term .


Women were randomly assigned according to a computer-generated allocation sequence to sequential use of double-balloon catheter and oral misoprostol ( study group ) or oral misoprostol alone ( control group ) .


In the study group , the double-balloon catheter was used the first day before starting oral misoprostol the second day .


The primary outcome measure was the induction-to-delivery interval , and a further outcome parameter was delivery within @ hours .


The median times for induction of labour until delivery were @ hours in the study group and @ hours in the control group ( P = @ ) .


This difference was not seen when evaluating according to parity ( nulliparous , P = @ ; parous , P = @ ) .


The rate of vaginal delivery within @ hours did not differ between both groups .


The number of applications of misoprostol ( two versus three , P < @ ) and the dose of misoprostol used was lower in the study group ( @ versus @ g , P < @ ) .


In the study group , there were more Apgar scores of < @ at @ minutes ( @ versus @ , P = @ ) .


The use of a double-balloon catheter on the first day , before starting oral misoprostol on the second day , did not improve the induction to delivery interval and the rate of delivery within @ hours , in comparison with oral misoprostol alone .


Patients with advanced basal cell carcinoma have limited treatment options .


Hedgehog pathway signalling is aberrantly activated in around @ % of tumours .


We assessed the antitumour activity of sonidegib , a Hedgehog signalling inhibitor , in patients with advanced basal cell carcinoma .


BOLT is an ongoing multicentre , randomised , double-blind , phase @ trial .


Eligible patients had locally advanced basal cell carcinoma not amenable to curative surgery or radiation or metastatic basal cell carcinoma .


Patients were randomised via an automated system in a @:@ ratio to receive @ mg or @ mg oral sonidegib daily , stratified by disease , histological subtype , and geographical region .


The primary endpoint was the proportion of patients who achieved an objective response , assessed in the primary efficacy analysis population ( patients with fully assessable locally advanced disease and all those with metastatic disease ) with data collected up to @ months after randomisation of the last patient .


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


Between July @ , @ , and Jan @ , @ , we enrolled @ patients , @ in the @ mg sonidegib group , and @ in the @ mg sonidegib group .


Median follow-up was @ months ( IQR @-@ ) .


In the primary efficacy analysis population , @ ( @ % , @ % CI @-@ ) of @ patients receiving @ mg sonidegib and @ ( @ % , @-@ ) of @ receiving @ mg sonidegib achieved an objective response .


In the @ mg sonidegib group , @ ( @ % , @ % CI @-@ ) patients who achieved an objective response , as assessed by central review , were noted among the @ with locally advanced basal cell carcinoma and two ( @ % , @-@ ) among the @ with metastatic disease .


In the @ mg group , @ ( @ % , @ % CI @-@ ) of @ patients with locally advanced disease had an objective response , as assessed by central review , as did four ( @ % , @-@ ) of @ with metastatic disease .


Fewer adverse events leading to dose interruptions or reductions ( @ -LSB- @ % -RSB- of @ patients vs @ -LSB- @ % -RSB- of @ ) or treatment discontinuation ( @ -LSB- @ % -RSB- vs @ -LSB- @ % -RSB- ) occurred in patients in the @ mg group than in the @ mg group .


The most common grade @-@ adverse events were raised creatine kinase ( five -LSB- @ % -RSB- in the @ mg group vs @ -LSB- @ % -RSB- in the @ mg group ) and lipase concentration ( four -LSB- @ % -RSB- vs eight -LSB- @ % -RSB- ) .


Serious adverse events occurred in @ ( @ % ) of @ patients in the @ mg group and @ ( @ % ) of @ patients in the @ mg group .


The benefit-to-risk profile of @ mg sonidegib might offer a new treatment option for patients with advanced basal cell carcinoma , a population that is difficult to treat .


The recent convergence between technology and medicine is offering innovative methods and tools for behavioral health care .


Among these , an emerging approach is the use of virtual reality ( VR ) within exposure-based protocols for anxiety disorders , and in particular posttraumatic stress disorder .


However , no systematically tested VR protocols are available for the management of psychological stress .


Our goal was to evaluate the efficacy of a new technological paradigm , Interreality , for the management and prevention of psychological stress .


The main feature of Interreality is a twofold link between the virtual and the real world achieved through experiential virtual scenarios ( fully controlled by the therapist , used to learn coping skills and improve self-efficacy ) with real-time monitoring and support ( identifying critical situations and assessing clinical change ) using advanced technologies ( virtual worlds , wearable biosensors , and smartphones ) .


The study was designed as a block randomized controlled trial involving @ participants recruited from two different worker populations-teachers and nurses-that are highly exposed to psychological stress .


Participants were a sample of teachers recruited in Milan ( Block @ : n = @ ) and a sample of nurses recruited in Messina , Italy ( Block @ : n = @ ) .


Participants within each block were randomly assigned to the ( @ ) Experimental Group ( EG ) : n = @ ; B@ = @ , B@ = @ , which received a @-week treatment based on the Interreality paradigm ; ( @ ) Control Group ( CG ) : n = @ ; B@ = @ , B@ = @ , which received a @-week traditional stress management training based on cognitive behavioral therapy ( CBT ) ; and ( @ ) the Wait-List group ( WL ) : n = @ , B@ = @ , B@ = @ , which was reassessed and compared with the two other groups @ weeks after the initial evaluation .


Although both treatments were able to significantly reduce perceived stress better than WL , only EG participants reported a significant reduction ( EG = @ % vs. CG = @ % ) in chronic `` trait '' anxiety .


A similar pattern was found for coping skills : both treatments were able to significantly increase most coping skills , but only EG participants reported a significant increase ( EG = @ % vs CG = @ % ) in the Emotional Support skill .


Our findings provide initial evidence that the Interreality protocol yields better outcomes than the traditionally accepted gold standard for psychological stress treatment : CBT .


Consequently , these findings constitute a sound foundation and rationale for the importance of continuing future research in technology-enhanced protocols for psychological stress management .


Patient assessments of disease activity ( PtGA ) and general health ( GH ) measured by visual analog scale ( VAS ) are widely used in rheumatoid arthritis ( RA ) clinical practice and research .


These require comprehension of the question 's wording and translation of disease activity onto a written VAS , which is problematic for patients with limited health literacy ( HL ) or difficulty completing forms .


This study 's objective was to validate verbally administered versions of patient assessments and identify factors that might explain discrepancies between verbal and written measures .


We enrolled patients with RA at the Denver Health rheumatology clinic ( n = @ ) .


Subjects were randomized to complete the traditional written PtGA and GH and one of the verbal assessments .


Subjects provided a verbal numeric response after reading the question , having the question read to them in person , or hearing the question over the phone .


Spearman and Lin correlations comparing written and verbal assessments were determined .


Multivariate logistic regression was performed to explain any discrepancies .


The instruments administered verbally in-person showed good , but not excellent , correlation with traditional written VAS forms ( Spearman coefficients @ to @ ; p < @ for all correlations ) .


Twenty-three percent of subjects were unable to complete @ of the written VAS assessments without assistance .


HL predicted missing written data and discrepancies between verbal and written assessments ( p < @ for all correlations ) .


Providers should use verbal versions of PtGA and GH with caution while caring for patients unable to complete traditional written version .


Limited HL is widely prevalent and a barrier to obtaining patient-oriented data .


Concomitant type @ diabetes ( T@D ) and metabolic syndrome exacerbates mortality risk ; yet , few studies have examined the effect of combining ( AER + RES ) aerobic ( AER ) and resistance ( RES ) training for individuals with T@D and metabolic syndrome .


We examined AER , RES , and AER + RES training ( @ months ) commensurate with physical activity guidelines in individuals with T@D ( n = @ ; @ % female , @ % black ) .


Primary outcomes were change in , and prevalence of , metabolic syndrome score at follow-up ( mean and @ % confidence interval -LSB- CI -RSB- ) .


Secondary outcomes included maximal cardiorespiratory fitness ( VO@peak ) and estimated METs from time-to-exhaustion ( TTE ) and exercise efficiency calculated as the slope of the line between ventilatory threshold , respiratory compensation , and maximal fitness .


General linear models and bootstrapped Spearman correlations were used to examine changes in metabolic syndrome associated with training primary and secondary outcome variables .


We observed a significant decrease in metabolic syndrome scores ( P for trend = @ ) for AER ( -@ , @ % CI = -@ to -@ ) and AER + RES ( -@ , @ % CI = -@ to -@ ) , both being significant ( P @ ) versus control ( @ , @ % CI = -@ to @ ) and RES ( -@ , @ % CI = -@ to @ ) .


This led to a reduction in metabolic syndrome prevalence for the AER ( @ % vs @ % ) and AER + RES ( @ % vs @ % ) groups between baseline and follow-up .


The observed decrease in metabolic syndrome was mediated by significant improvements in exercise efficiency for the AER and AER + RES training groups ( P < @ ) , which was more strongly related to TTE ( @ % -@ % ; r = -@ , @ % CI = -@ to -@ ) than VO@peak ( @ % -@ % ; r = -@ , @ % CI = -@ to -@ ) .


AER and AER + RES training significantly improved metabolic syndrome scores and prevalence in patients with T@D .


These improvements appear to be associated with improved exercise efficiency and are more strongly related to improved TTE versus VO@peak .


The pathophysiology of erectile dysfunction ( ED ) may be vasculogenic , hormonal , anatomical , neurogenic , drug-induced and/or psychogenic in origin .


Neuropathic pain ( NP ) may facilitate ED , because it is frequently associated with anxiety , depression , and its drug , pregabalin , may also contribute ED .


The objective of this study was to determine whether pregabalin treatment for patients with neuropathic pain promotes erectile dysfunction .


The study sample consisted of a total of @ male subjects that were subdivided into three groups .


Group @ patients ( n = @ ) had a pre-existing diagnosis of NP and was treated with @mg/day of pregabalin for at least @ months .


Group @ patients ( n = @ ) were diagnosed with NP for at least @ months ; however , neither were they treated with pregabalin nor did they received physical therapy throughout the study .


Lastly , healthy age-matched control subjects comprised group @ ( n = @ ) .


Patients in all groups completed the International Index for Erectile Function ( IIEF ) questionnaire .


Mean age and mean body mass index did not differ significantly between each of the three groups .


The cause of NP and the mean duration of having a diagnosis of NP did not differ significantly in groups @ and @ .


However , IIEF scores were significantly lower for group @ when compared to group @ in terms of erectile function , orgasmic function , overall satisfaction and total score .


Yet groups @ and @ did not diverge significantly in the intercourse satisfaction and sexual desire scores .


Overall IIEF scores for group @ were significantly higher than those of group @ except for mean erectile function scores .


Taking pregabalin for the treatment of neuropathic pain poses an increased risk for developing ED in male patients .


Thus , clinicians prescribing pregabalin to patients diagnosed with neuropathic pain should assess for ED before and during treatment with this medication .


To study the effect of Zhibai Dihuang Pill ( ZBDHP ) on urokinase-type plasminogen activator ( uPA ) and sperm quality in ureaplasma urealyticum ( Uu ) infection infertile patients .


Recruited were @ infertility patients with Uu infection at Andriatrics Clinics and Department of Reproduction , including @ cases of positive Uu semen and @ cases of negative Uu semen .


Patients with positive Uu semen were randomly assigned to the observation group ( @ cases ) and the control group ( @ cases ) according to the visit sequence .


All patients took antibiotics for @ weeks .


Patients in the observation group additionally took ZBDHP , @ g each time , twice daily .


Those in the control group additionally took Vit E ( @ mg each time , twice per day ) and ATP ( @ mg each time , twice per day ) .


The therapeutic course for all was @ days .


Semen parameters and uPA contents of the sperm membrane were detected and comparatively analyzed .


The sperm membrane uPA content , the sperm motility , the sperm viability , and the percentage of normal morphology sperm in Uu positive infected patients were lower than those in Uu negative infected patients with statistical difference ( P < @ ) , but with no significant difference in the sperm density between the two groups ( P > @ ) .


There was no statistical difference in pre-treatment sperm membrane uPA contents and sperm parameters between the two groups ( P > @ ) .


Compared with before treatment in the same group , the sperm membrane uPA content , the sperm motility , the sperm viability , and the percentage of normal morphology sperm obviously increased in the two groups with statistical difference ( P < @ ) .


After treatment , the sperm membrane uPA content increased more obviously in the observation group , with statistical difference when compared with the control group ( P < @ ) .


Infection with Uu leads to decreased uPA content of sperm membrance and the sperm motility .


ZBDHP could effectively treat Uu infected infertility possibly through fighting against Uu damaged sperm membrane and make the sperm membrane uPA content return to normal , and elevate the fertilizability of sperms .


To observe the impacts on the muscle strength in the patients of stroke-induced acroparalysis treated with Xunjingcuiqi needling technique .


One hundred patients were randomized into a Xunjingcuiqi group and a routine acupuncture group , @ cases in each group .


In the routine acupuncture group , the routine acupuncture technique was adopted at the main acupoints , such as Shangxing ( GV @ ) , Baihui ( GV @ ) , Dicang ( ST @ ) , Quchi ( LI @ ) , Huantiao ( GB @ ) and Zusanli ( ST @ ) , etc. .


In Xunjingcuiqi group , on the basis of the routine acupuncture technique , Xunjingcuiqi needling technique ( pricking technique was quickly applied with the filiform needle along the running course of meridian to promote the conduction of meridian qi ) was added .


For the patients being hard to feel the needling sensation and with the muscle strength of @ to @ degree , Dongzhencuiqi technique was supplemented at shu-stream points of yang meridians ( after qi arrival , the needling manipulation with limb movement was given to promote the conduction of meridian qi ) .


The treatment was given once every day in the two groups .


Ten treatments made one session .


Three sessions of treatment were required .


At the end of each session treatment , the muscle strength and clinical efficacy were assessed .


In the @st , @nd and @rd sessions of treatment , @ , @ and @ cases achieved the @ to @ degrees muscle strength in Xunjingcuiqi group , respectively ; and @ , @ and @ cases achieved the @ to @ degrees muscle strength in the routine acupuncture group .


The differences were significant statistically in comparison of the two groups ( P < @ , P < @ ) .


The markably effective rates were @ % ( @/@ ) , @ % ( @/@ ) and @ % ( @/@ ) after the @st , @nd and @rd sessions of treatment in Xunjingcuiqi group , respectively ; and those were @ % ( @/@ ) , @ % ( @/@ ) and @ % ( @/@ ) in the routine acupuncture group , respectively .


The differences were significant in the @st and @rd sessions of treatment between the two groups ( both P < @ ) .


Xunjingcuiqi needling technique combined with routine acupuncture achieves the apparent superior efficacy on acroparalysis induced by ischemic stroke as compared with the simple routine acupuncture .


Xunjingcuiqi needling technique obviously improves muscle strength and shortens the duration of sickness .


To assess the level of evidence-based drug prescribing for acute coronary syndrome ( ACS ) at discharge from Western Australian ( WA ) hospitals and determine predictors of such prescribing in Aboriginal and non-Aboriginal patients .


All Aboriginal ( @-@ ) and a random sample of non-Aboriginal ( @ ) hospital admissions with a principal diagnosis of ACS were extracted from the WA Hospital Morbidity Data Collection of WA Data Linkage System .


Clinical information , history of co-morbidities and drugs were collected from medical notes by trained data collectors .


Evidence-based prescribing ( EBP ) was defined as prescribing of aspirin , statin and beta-blocker or angiotensin-converting enzyme inhibitor/angiotensin II antagonist .


Records for @ ACS patients discharged alive from hospitals were reviewed .


The majority of patients ( @ % ) had EBP , and there was no significant difference between Aboriginal and non-Aboriginal patients ( @ % vs @ % , P = @ ) .


Conversely , a significantly higher proportion of Aboriginal patients had none of the drugs prescribed compared with non-Aboriginal patients ( @ % vs @ % , P < @ ) .


EBP for ACS was independently associated with male sex ( odds ratio ( OR ) @ , @ % confidence interval ( CI ) @-@ @ ) , previous admission for ACS ( OR @ , @ % CI @-@ @ ) and diabetes ( OR @ , @ % CI @-@ @ ) .


However , ACS patients living in regional and remote areas , attending district or private hospitals , or with a history of chronic obstructive pulmonary disease were significantly less likely to have ACS drugs prescribed at discharge .


Opportunity exists to improve prescribing of recommended drugs for ACS patients at discharge from WA hospitals in both Aboriginal and non-Aboriginal patients .


Attention regarding pharmaceutical management post-ACS is particularly required for patients from rural and remote areas , and those attending district and private hospitals .


Wound cleansing should create an optimal healing environment by removing excess debris , exudates , foreign and necrotic material which are commonly present in the wounds that heal by secondary intention .


At present , there is no research evidence for whether pressurised irrigation has better wound healing outcomes compared with conventional swabbing practice in cleansing wound .


This study investigated the differences between pressurised irrigation and swabbing method in cleansing wounds that healed by secondary intention in relation to wound healing outcomes and cost-effectiveness .


Multicentre , prospective , randomised controlled trial .


The study took place in four General Outpatient Clinics in Hong Kong .


Two hundred and fifty six patients with wounds healing by secondary intention were randomly assigned by having a staff independent of the study opening a serially numbered , opaque and sealed envelope to either pressurised irrigation ( n = @ ) or swabbing ( n = @ ) .


Staff undertaking study-related assessments was blinded to treatment assignment .


Patients ' wounds were followed up for @ weeks or earlier if wounds had healed to determine wound healing , infection , symptoms , satisfaction , and cost effectiveness .


The primary outcome was time-to-wound healing .


Patients were analysed according to their treatment allocation .


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


Intention-to-treat analysis showed that pressurised irrigation group was associated with a shorter median time-to-wound healing than swabbing group -LSB- @ days ( @ % CI : @-@ @ ) vs. @ ( @ % CI : @-@ @ ) ; p = @ -RSB- .


Pressurised irrigation group has significantly more patients experiencing lower grade of pain during wound cleansing ( @ % vs. @ % ; p = @ ) , and significantly higher median satisfaction with either comfort or cleansing method ( MD @ -LSB- @ % CI : @-@ -RSB- ; p = @ ; MD @ -LSB- @ % CI : @-@ -RSB- ; p < @ ) than did swabbing group .


Wound infection was reported in @ ( @ % ) patients in pressurised irrigation group and in @ ( @ % ) patients in swabbing group ( p = @ ) .


Cost-effectiveness analysis indicated that pressurised irrigation in comparison with swabbing saved per patient HK$ @ ( @ % CI : -@ to @ ) and was a cost-effective cleansing method at no extra direct medical cost with a probability of @ % .


This is the first randomised controlled trial to compare the pressurised irrigation and swabbing .


Pressurised irrigation is more cost-effective than swabbing in shortening time that wound heals by secondary intention with better patient tolerance .


Use of pressurised irrigation for wound cleansing is supported by this trial .


Some investigators found a greater incidence of hypotension in patients receiving intrathecal hyperbaric solution than in patients receiving plain solution for cesarean section .


Compare the effects of intrathecal hyperbaric bupivacaine @ mg with intrathecal bupivacaine @ mg and intrathecal levobupivacaine @ mg , all with @ microg of fentanyl , for cesarean section .


This prospective , randomized , double-blinded study was approved by the Ethics Committee .


Ninety ASA I-II parturients undergoing elective cesarean section were enrolled .


Group H received @ mg of @ % hyperbaric bupivacaine plus fentanyl @ g , Group B received @ mg of @ % bupivacaine plus fentanyl @ g , and Group L received @ mg of @ % levobupivacaine plus fentanyl @ g. Spinal anesthesia ( SA ) was undertaken in right lateral position and spinal solutions were injected approximately @ to @ seconds .


Sensory and motor block were assessed at @-minute intervals .


Side-effects such as hypotension , nausea , pruritus , shivering , and headache were recorded


Demographic data were similar in all groups .


The level of an absence of cold sensation , the level of pinprick analgesia , and time to achieve sensory block to T@ level of Group H was significantly higher than Group B and Group L.


The degree of motor block was comparable in all groups .


The incidence of visceral pain was minimal , rated as mild pain and only found in Group B.


The incidence of hypotension was comparable with Group H = @ % , Group B = @ % , and Group L = @ % .


Other side effects such as nausea , vomiting , pruritus , shivering , and headache were not statistically significant .


Patient 's satisfaction rated as very good and was not different between the three groups .


The level of absence of cold sensation , level of pinprick analgesia , and time to achieve sensory block to T@ level were statistically higher in patients receiving hyperbaric bupivacaine than in patients receiving plain bupivacaine and plain levobupivacaine , while the differences were not statistically significant in all groups regarding effective surgical anesthesia , postoperative analgesia , and side effects .


Therefore , Levobupivacaine can be an alternative to bupivacaine .


To investigate the effects of whole body vibration ( WBV ) training on gait function in persons with mild multiple sclerosis ( MS ) .


A randomized controlled trial .


@ patients with MS were assigned randomly to WBV ( intervention group ) or to placebo WBV .


Both groups performed a @-week training period under static conditions on a vibration platform .


In the placebo group , the vibration platform was covered and therefore vibrations could not operate .


Gait function ( gait velocity , stride length , double support phase , single-step variability left and right ) was assessed at baseline , after @-weeks of WBV intervention or sham WBV , @-weeks after baseline , and @-weeks after baseline using a mobile plantar food pressure system and the `` Timed Up and Go '' test under four different gait conditions ( comfortable overground gait , comfortable gait on treadmill , -@ % comfortable gait velocity on treadmill and +@ % comfortable gait velocity on treadmill ) .


None of the outcome measures of gait function showed statistically significant alterations following @-weeks of intervention/placebo WBV .


The applied protocol of WBV does not show a meaningful improvement of gait function in mildly affected MS patients .


Computer-assisted surgery ( CAS ) may facilitate better positioning of total knee arthroplasty ( TKA ) along the coronal and lateral axes ; however , there are doubts as to its usefulness in the rotational plane .


This is a prospective study of @ TKAs comparing two groups : the CAS group and the standard equipment group .


The series comprises @ cases .


A radiography of the lower limb and computer tomographies ( CTs ) of the femoral condylar region , the proximal end of the tibia and the ankle were performed to measure rotational angulation .


A month after TKA surgery , the radiography and the CTs were repeated to analyze the position of the prosthetic components in the rotational plane .


In the coronal axis , both CAS and mechanical technique improved femoro-tibial alignment , but when there are preexisting deformities @ , CAS obtains better results .


A strong correlation ( R = @ , p = @ ) was observed between the mean rotational axis measured with CT in the tibial plateau and that measured from the axis of the ankle .


The mean initial femoral rotation of the complete series was @ and @ at @-month follow-up ( p < @ ) .


In the standard instrumentation group , the femoral rotation went from @ to @ , whereas in the CAS group the femoral rotation went from @ to @ ( p = @ ) , which is very close to the ideal @ angle of external rotation .


Tibial rotation changed by @ for the entire patient population , but no differences were found when comparing CAS and standard instrumentation .


CAS improves frontal alignment in TKA , especially in the presence of preoperative deformities .


In the femoral component , navigation most closely replicated the ideal @ external rotation of the femoral component , but tibial rotation did not differ when comparing CAS to standard instrumentation .


Although minocycline is not licensed for use in dogs , this tetracycline has therapeutic potential against meticillin-resistant Staphylococcus pseudintermedius .


The aim of this study was to establish rational dosage recommendations for minocycline use in dogs .


Specific objectives were to generate and analyse minocycline pharmacokinetic ( PK ) data on plasma and interstitial fluid ( ISF ) concentrations , plasma protein binding and pharmacodynamic ( PD ) data on antimicrobial activity against S.pseudintermedius .


Six healthy dogs from a research colony were used in this study .


Dogs were administered @mg/kg intravenously and @mg/kg orally ( p.o. ) of minocycline hydrochloride in separate crossover experiments .


In vivo drug concentrations in plasma and in ISF collected by ultrafiltration were measured by high-performance liquid chromatography .


Pharmacokinetic analysis was performed on plasma and ISF concentrations .


PK/PD analysis was completed using in vitro data on plasma protein binding and minocycline susceptibility in @ S.pseudintermedius isolates .


Minocycline distributed to the ISF to a higher degree than predicted by the protein-unbound fraction in plasma .


A large volume of distribution after oral administration , with plasma and ISF elimination half-lives of @ and @ h , respectively , demonstrated that the ISF serves as a drug reservoir for sustained tissue concentrations .


Monte Carlo simulation , used to assess target attainment at different drug dosages , indicated that p.o. administration of @mg/kg twice daily is sufficient to inhibit S.pseudintermedius strains with minimal inhibitory concentrations @ g/mL .


Besides dosage recommendations for therapy of meticillin-resistant Staphylococcus pseudintermedius infections in dogs , the study also provides PK/PD data necessary to consider species-specific clinical breakpoints for minocycline susceptibility testing .


Turning gait is an integral part of daily ambulation and likely poses a greater challenge for patients with transtibial amputation compared with walking a straight pathway .


A torsion adapter is a prosthetic component that can increase transverse plane compliance of the prosthesis and decrease the torque applied to the residual limb , but whether this will improve patients ' mobility , pain , and fatigue remains unknown .


Does prescription of a torsion adapter translate to improvements in ( @ ) functional mobility and ( @ ) self-perceived pain and fatigue in moderately active patients with lower limb amputation ?


Ten unilateral transtibial amputees wore a torsion or rigid adapter in random order .


Functional mobility was assessed through a field measurement using an activity monitor and through a laboratory measurement using a @-minute walk test that included turns .


The residual limb pain grade assessed self-perceived pain and the Multidimensional Fatigue Inventory assessed fatigue .


We found relatively small functional differences for amputees wearing a torsion adapter versus a rigid adapter .


Amputees wearing a torsion adapter tended to take more low - and medium-intensity steps per day ( @ @ and @ @ difference in steps ; effect size = @ and @ ; confidence interval -LSB- CI -RSB- , @-@ and @-@ ; p = @ and @ , respectively ) .


They also experienced less pain interference with activities ( @ @ change in score ; effect size = @ ; CI , @-@ @ ; p = @ ) when wearing a torsion adapter .


However , these patients took a similar number of total steps per day , walked a comparable distance in @ minutes , and reported similar residual limb pain and fatigue .


For a moderately active group of amputees , the torsion adapter did not translate to substantial improvements in functional mobility and self-perceived pain and fatigue .


The small increases in low - and medium-intensity activities with less pain interference when wearing a torsion adapter provides evidence to support prescribing this device for amputees with difficulty navigating the household and community environments .


This study was designed to investigate the effect of a single-drop instillation of different lacrimal substitutes on tear film thickness ( TFT ) assessed with optical coherence tomography in patients with mild to moderate dry eye disease .


The study was performed in a randomized , double-masked , controlled parallel group design .


Patients received a single dose of either unpreserved trehalose @ mg/mL and sodium hyaluronate @ mg/mL ( TH-SH , Thealoz Duo ) , unpreserved sodium hyaluronate , @ % ( HA , Hyabak ) or sodium chloride , @ % ( NaCl , Hydrabak ) eye drops .


Sixty patients finished the study according to the protocol .


TFT was measured with a custom-built ultrahigh-resolution Fourier domain optical coherence tomography system providing a resolution of @ m.


The mean TFT before treatment was @ @ m. Ten minutes after instillation , TFT significantly increased in the TH-SH group from @ @ to @ @ m ( P < @ ) and in the HA group from @ @ to @ @ m ( P < @ ) , whereas no significant change was observed in the NaCl group ( from @ @ to @ @ m , P = @ ) .


The increase in TFT remained statistically significant up to @ minutes after administration of TH-SH .


In contrast , the increase in TFT after administration of HA was only statistically significant at @ , @ , and @ minutes after drop instillation .


The findings of this study indicate that single instillation of TH-SH and HA eye drops increases TFT in patients with dry eye disease .


The data also indicate longer corneal residence of the TH-containing eye drops .


The effect of multiple instillation and long-term use of artificial tears on TFT warrants further investigation .


To evaluate the effect of intense pulsed light ( IPL ) applied to the periocular area for meibomian gland dysfunction ( MGD ) in a prospective , double-masked , placebo-controlled , paired-eye study .


Twenty-eight participants underwent IPL treatment , with homogeneously sequenced light pulses delivered to one eye and placebo treatment to the partner control eye at @ , @ , and @ days following baseline ( BL ) evaluation .


Lipid layer grade ( LLG ) , noninvasive tear break-up time ( NIBUT ) , tear evaporation rate ( TER ) , tear meniscus height ( TMH ) , and subjective symptom score using visual analogue scales ( VAS ) were compared with BL and control values at each visit .


Lipid layer grade improved significantly from BL to Day ( D ) @ in the treated eye ( P < @ ) , but not the control eye ( P = @ ) , with @ % of treated eyes improving by at least one LLG .


Noninvasive tear break-up time also improved significantly from BL to D@ in the treated ( P < @ ) but not in the control eye ( P = @ ) and was significantly longer than in the treated eye at D@ ( @ @ seconds versus @ @ seconds , P < @ ) .


The tear evaporation rate was not different in the treated eye compared with the control eye at any visit .


Tear meniscus height did not change from BL in either eye ( P > @ ) .


Visual analog scale symptom scores improved from BL in the treated ( P = @ ) , but not the control eye ( P = @ ) , with @ % of participants noting reduced symptoms in the treated eye by D@ .


Intense pulsed light with multiple sculpted pulses shows therapeutic potential for MGD , improving tear film quality and reducing symptoms of dry eye .


( https://www.anzctr.org.au number , ACTRN@ . )


To compare the efficacy of topical @ % voriconazole vs @ % natamycin for the treatment of fungal keratitis .


In a prospective , double-masked , randomised , controlled , registered clinical trial , @ patients with fungal keratitis were treated using identical dosage schedule with either voriconazole ( @ ) or natamycin ( @ ) as inpatients for @days and followed up weekly .


The outcome measures were percentage of patients with healed or resolving ulcer and final visual acuity at last follow-up ( primary ) and on day @ ( secondary ) in each group .


More patients ( p = @ ) on natamycin ( @/@ , @ % ) had healed or resolving ulcer compared with voriconazole ( @/@ , @ % ) at last follow-up .


The improvement in vision was marginally greater in patients in the natamycin group compared with the voriconazole group at day @ ( p = @ ) and significantly greater at final visit ( p = @ ) .


In univariate analysis , drug , age and mean size of corneal infiltrate and epithelial defect had a significant effect on the final visual outcome .


In multivariate analysis , the effect of drug ( voriconazole vs natamycin , adjusted coefficient @ ( -@ to @ ) , p = @ ) was marginal while the effect of age and epithelial defect was significant ( p < @ for both ) .


In the group treated with natamycin , the final visual acuity was significantly better ( p = @ , Wilcoxon signed-rank test ) in patients with Fusarium keratitis but not with Aspergillus keratitis ( p = @ , paired t test ) .


When compared with voriconazole , natamycin was more effective in the treatment of fungal keratitis , especially Fusarium keratitis .


The Radiation Therapy Oncology Group @ study identified good-risk patients with ductal carcinoma in situ ( DCIS ) , a breast cancer diagnosis found frequently in mammographically detected cancers , to test the benefit of radiotherapy ( RT ) after breast-conserving surgery compared with observation .


This prospective randomized trial ( @ to @ ) in women with mammographically detected low - or intermediate-grade DCIS , measuring less than @ cm with margins @ mm , compared RT with observation after surgery .


The study was designed for @,@ patients but was closed early because of lower than projected accrual .


Six hundred thirty-six patients from the United States and Canada were entered ; tamoxifen use ( @ % ) was optional .


Ipsilateral local failure ( LF ) was the primary end point ; LF and contralateral failure were estimated using cumulative incidence , and overall and disease-free survival were estimated using the Kaplan-Meier method .


Median follow-up time was @ years ( range , @ to @ years ) .


Two LFs occurred in the RT arm , and @ occurred in the observation arm .


At @ years , the LF rate was @ % ( @ % CI , @ % to @ % ) in the RT arm versus @ % ( @ % CI , @ % to @ % ) in the observation arm ( hazard ratio , @ ; @ % CI , @ to @ ; P < @ ) .


Grade @ to @ acute toxicities occurred in @ % and @ % of patients in the observation and RT arms , respectively ; grade @ or @ toxicities occurred in @ % and @ % of patients , respectively .


Late RT toxicity was grade @ in @ % , grade @ in @ % , and grade @ in @ % of patients .


In this good-risk subset of patients with DCIS , with a median follow-up of @ years , the LF rate was low with observation but was decreased significantly with the addition of RT. .


Longer follow-up is planned because the timeline for LF in this setting seems protracted .


To evaluate the effects of @ low-calorie diets but with different distributions of calories throughout the day on weight loss and other major obesity-related metabolic parameters .


We randomly assigned @ nonsmoking homemakers ( age = @ @ years , body mass index -LSB- BMI -RSB- = @ @ kg/m ( @ ) , mean SD ) in @ groups of @ subjects ( G@ and G@ ) .


The participants underwent a @ month individualized Mediterranean-style diet ( @ % carbohydrate , @ % fat , @ % protein and fiber > @ g ) , calorie ( @ kcal daily deficit compared to the total energy expenditure measured by a metabolic Holter ) .


Diets consisted of the same food and complied with cardiovascular disease prevention guidelines but differed in the distribution of calories throughout the day ( G@ : @ % breakfast , morning snack , lunch and @ % afternoon snack and dinner ; G@ : @ breakfast , morning snack , lunch and @ % afternoon snack and dinner ) .


Dual-energy X-ray absorptiometry was used for pre - and postintervention body composition assessment .


Thirty-six subjects completed the study ( G@ = @ , G@ = @ ) .


Both groups had significant improvements in body composition and metabolic parameters but G@ had enhanced results for weight loss ( G@ : -@ @ kg ; G@ : -@ @ kg ; p = @ ) , waist circumference reduction ( G@ : -@ @ cm ; G@ : -@ @ cm ; p = @ ) , and fat mass loss ( G@ : -@ @ kg , G@ : -@ @ kg , p = @ ; mean SD ) .


Improvements were detected in both groups for blood pressure and blood and lipid parameters .


G@ subjects showed a greater improvement in insulin sensitivity measured by homeostasis model assessment-estimated insulin resistance ( G@ : -@ @ , G@ : -@ @ , p = @ ) .


These data suggest that a low-calorie Mediterranean diet with a higher amount of calories in the first part of the day could establish a greater reduction in fat mass and improved insulin sensitivity than a typical daily diet .


Dynamic contrast-enhanced magnetic resonance imaging ( DCE-MRI ) is increasingly used for breast cancer diagnosis as supplementary to conventional imaging techniques .


Combining of diffusion-weighted imaging ( DWI ) of morphology and kinetic features from DCE-MRI to improve the discrimination power of malignant from benign breast masses is rarely reported .


The study comprised of @ female patients with @ benign and @ malignant lesions .


Four distinct groups of features , coupling with pathological tests , were estimated to comprehensively characterize the pictorial properties of each lesion , which was obtained by a semi-automated segmentation method .


Classical machine learning scheme including feature subset selection and various classification schemes were employed to build prognostic model , which served as a foundation for evaluating the combined effects of the multi-sided features for predicting of the types of lesions .


Various measurements including cross validation and receiver operating characteristics were used to quantify the diagnostic performances of each feature as well as their combination .


Seven features were all found to be statistically different between the malignant and the benign groups and their combination has achieved the highest classification accuracy .


The seven features include one pathological variable of age , one morphological variable of slope , three texture features of entropy , inverse difference and information correlation , one kinetic feature of SER and one DWI feature of apparent diffusion coefficient ( ADC ) .


Together with the selected diagnostic features , various classical classification schemes were used to test their discrimination power through cross validation scheme .


The averaged measurements of sensitivity , specificity , AUC and accuracy are @ , @ , @ % and @ , respectively .


Multi-sided variables which characterize the morphological , kinetic , pathological properties and DWI measurement of ADC can dramatically improve the discriminatory power of breast lesions .


Depression is one of the most common disorders in Psychiatric and Primary Care settings and is associated with significant disability and economic costs .


Low-intensity psychological interventions applied by Information and Communication Technologies ( ICTs ) could be an efficacious and cost-effective therapeutic option for the treatment of depression .


The aim of this study is to assess @ low-intensity psychological interventions applied by ICTs ( healthy lifestyle , positive affect and mindfulness ) in Primary Care ; significant efficacy for depression treatment has previously showed in specialized clinical settings by those interventions , but ICTs were not used .


Multicenter controlled randomized clinical trial in @ parallel groups .


Interventions have been designed and on-line device adaptation has been carried out .


Subsequently , the randomized controlled clinical trial will be conducted .


A sample of N = @ mild and moderate depressed patients will be recruited and assessed in Primary Care settings .


Patients will be randomly assigned to a ) healthy lifestyle psychoeducational program + improved primary care usual treatment ( ITAU ) , b ) focused program on positive affect promotion + ITAU c ) mindfulness + ITAU or d ) ITAU .


The intervention format will be one face to face session and four ICTs on-line modules .


Patients will be diagnosed with MINI psychiatric interview .


Main outcome will be PHQ-@ score .


They will be also assessed by SF-@ Health Survey , Client Service Receipt Inventory , EuroQoL-@D questionnaire , Positive and Negative Affect Scale , Five Facet Mindfulness Questionnaire and the Pemberton Happiness Index .


Patients will be assessed at baseline , post , @ and @ post-treatment months .


An intention to treat and per protocol analysis will be performed .


Low-intensity psychological interventions applied by Information and Communication Technologies have been not used before in Spain and could be an efficacious and cost-effective therapeutic option for depression treatment .


The strength of the study is that it is the first multicenter controlled randomized clinical trial of three low intensity and self-guided interventions applied by ICTs ( healthy lifestyle psychoeducational program ; focused program on positive affect promotion and brief intervention based on mindfulness ) in Primary Care settings .


In Lebanon , childhood obesity doubled during the past decade .


Preventive measures should start early in life and Schools are considered an important environment to promote energy balance health behaviours .


School-based programmes promoting healthy lifestyles are lacking .


The purpose of this study was to evaluate the feasibility and effectiveness of a multicomponent school-based intervention to promote healthy eating and physical activity ( and prevent obesity ) with school children aged @-@ years in Lebanon .


The intervention was developed based on the constructs of the Social Cognitive Theory and adapted to the culture of Lebanese and Arab populations .


It consisted of three components : class curriculum , family involvement and food service .


Eight schools were purposively selected from two communities of different socioeconomic status ( SES ) in Beirut and , within each school type , were matched on SES , religious sect profile , and then randomly assigned to either the intervention or control group .


Anthropometric measurements and questionnaires on determinants of behavioural change , eating and physical activity habits were completed by the students in both groups at baseline and post intervention .


Focus group interviews were conducted in intervention schools at the end of the study .


Challenges encountered during the programme implementation were also identified , since Lebanon is considered a country with political unrest and no similar research projects were conducted in the area .


Students in the intervention group reported purchasing and consuming less chips and sweetened drinks post-intervention compared with controls ( @ % & @ % less respectively p < @ ) .


Knowledge and self-efficacy scores increased for the intervention ( +@ & +@ points respectively p < @ ) but not for the control group .


There was no difference in physical activity and screen time habits and no changes in BMI between groups at post intervention .


Interview data from focus groups showed that the programme was generally well accepted .


Limitations for better outcomes include the length of the programme and the school environment .


`` Health-E-PALS '' intervention is a promising innovative , theory-based , culturally sensitive intervention to promote healthy eating habits and physical activity in Lebanese school children with a potential to be scaled up , replicated and sustained .


Melasma is an acquired hyperpigmentation on sun-exposed areas .


Multiple approaches are used to treat it , but all include broad ultraviolet ( UV ) - spectrum sunscreens .


Visible light ( VL ) can induce pigmentary changes similar to those caused by UV radiation on darker-skinned patients .


To assess the efficacy of sunscreen with broad-spectrum UV protection that contains iron oxide as a VL-absorbing pigment ( UV-VL ) compared with a regular UV-only broad-spectrum sunscreen for melasma patients exposed to intense solar conditions .


Sixty-eight patients with melasma were randomized in two groups to receive either UV-VL sunscreen or UV-only sunscreen , both with sun protection factor @ , over @ weeks .


All patients received @ % hydroquinone as a depigmenting treatment .


At onset and at conclusion of the study , they were assessed by the Melasma Activity and Severity Index ( MASI ; a subjective scale ) , colorimetry ( L * ) and histological analysis of melanin .


Sixty-one patients concluded the study .


At @ weeks , the UV-VL group showed @ % , @ % and @ % greater improvements than the UV-only group in MASI scores , colorimetric values and melanin assessments , respectively .


UV-VL sunscreen enhances the depigmenting efficacy of hydroquinone compared with UV-only sunscreen in treatment of melasma .


These findings suggest a role for VL in melasma pathogenesis .


Both vitamin C deficiency and inflammation are prevalent in maintenance hemodialysis ( MHD ) patients .


In this study , we aimed to elucidate the effect of oral vitamin C supplementation on inflammatory status in MHD patients with low vitamin C level and high hypersensitive C-reactive protein ( hs-CRP ) level .


A total of @ patients were recruited in our present study .


Patients were divided into two groups .


In group @ ( n = @ ) , patients were orally administered with @ mg/day vitamin C in the first @ months , and then the vitamin C supplementation was withdrawn in the next @ months .


In group @ ( n = @ ) , patients were not given vitamin C in the first @ months , and then they were orally administered with @ mg/day in the next @ months .


Levels of hs-CRP , prealbumin , albumin and hemoglobin as well as the EPO resistance index ( ERI ) were determined at the baseline and every @ months throughout the study .


Plasma vitamin C level was determined by high-performance liquid chromatography with UV detection .


Among the @ patients , @ of them dropped out of the study before completion .


Consequently , a total of @ patients ( group @ : n = @ ; group @ : n = @ ) were included in the final analysis .


At the baseline , the plasma vitamin C level of all patients was less than @ g/mL .


However , this proportion was decreased to @ % after the vitamin C supplementation for @ months .


Compared with patients without the vitamin C supplementation , a decreased level of hs-CRP and an increased level of prealbumin were induced by the vitamin C supplementation for @ months in both groups .


However , levels of these biomarkers returned to their original state after the supplementation was withdrawn .


Same beneficial effects on plasma albumin , hemoglobin and ERI response to vitamin C supplementation were observed in the two groups without statistical significance .


The inflammatory status in MHD patients with plasma vitamin C deficiency and high levels of inflammatory markers could be partially improved by long-term oral administration of small doses of vitamin C.


Pharmacodynamic analysis of intravenous recombinant urate oxidase produced by Escherichia coli was performed in healthy subjects using a pharmacokinetic/pharmacodynamic ( PK/PD ) model .


A randomized , single-blind , placebo-controlled study was performed in @ healthy Chinese subjects ( @ groups of @ subjects each , placebo @:@ ratio ) who received infusions of uricase ( single doses of @ , @ , and @ mg/kg ; multiple doses of @ mgkg ( -@ ) d ( -@ ) for @ d ) .


PK profiles were determined through plasma uricase activity , and PD profiles were established using uric acid levels in plasma and urine .


The plasma PD parameter was estimated as changes in plasma uric acid levels as the effect in the indirect response model .


Adverse events were also monitored .


A two-compartment PK model with constant iv input and first-order output was used to describe the kinetic process of plasma uricase .


The low value ( @ U/L ) of drug concentration that achieved @ % of maximum effect ( EC@ ) indicated that low plasma uricase concentrations were sufficient to produce pharmacological effects .


A strong relationship ( r ( @ ) = @ ) between the mean uric acid concentration in blood and the mean uric acid excretion rate in urine in the range of @ to @ h after single dosing was found .


Infusions of uricase were well tolerated in all subjects .


The PK/PD model predicted the effective dose to be @ mg/kg in healthy subjects .


The excretion rate of uric acid in urine may be used as a new index for pharmacological effects in further clinical trials .


To study the effect of Bushen Huoxue Herbs on depression of patients with Parkinson 's disease .


Ninety-six patients were randomized into two groups with @ patients in the treatment group and @ patients in the control group .


Both groups took western medicine as basic treatment .


The treatment group was treated with Bushen Huoxue Herbs additionally .


The observation was carried out for @ months .