nils-herrmann/clean_scirepeval huggingface dataset:
Long-term outcome with dasatinib after imatinib failure in chronic-phase chronic myeloid leukemia: follow-up of a phase 3 study.

We present long-term follow-up of a dasatinib phase 3 study of patients with imatinib-resistant/-intolerant chronic myeloid leukemia (CML). In the CA180-034 study, 670 patients with imatinib-resistant/-intolerant CML in chronic phase (CML-CP) received dasatinib 100 mg once daily, 50 mg twice daily, 140 mg once daily, or 70 mg twice daily. At 6 years, 188 (28%) of 670 patients remained on study treatment. Estimated 6-year protocol-defined progression-free survival (PFS) rates were 49%, 51%, 40%, and 47%, respectively, and estimated 6-year overall survival (OS) rates were 71%, 74%, 77%, and 70%, respectively (intent-to-treat population, including protocol-defined progression or death after discontinuation). Estimated 6-year rates of survival without transformation on study treatment were 76%, 80%, 83%, and 74%, respectively. Major molecular response was achieved in 43% (100 mg once daily) and 40% (all other arms) of patients by 6 years. Molecular and cytogenetic responses at 3 and 6 months were highly predictive of PFS and OS. Notably, estimated 6-year PFS rates based on ≤1%, >1% to 10%, and >10% BCR-ABL transcripts at 3 months were 68%, 58%, and 26%, respectively. Most adverse events occurred by 2 years. Imatinib-resistant/-intolerant patients with CML-CP can experience long-term benefit with dasatinib therapy, particularly if achieving BCR-ABL ≤10% at 3 months.
Svelte integrated delivery system performance examined through diagnostic catheter delivery: the SPEED registry.

The multi-center SPEED registry evaluated the procedural success and in-hospital clinical outcomes of direct stenting with the Svelte 'all-in-one' coronary stent Integrated Delivery System (IDS) through diagnostic catheters to identify the clinical indications for which this approach is appropriately suited.



Forty-eight (48) patients with 54 lesions of lengths ≤20 mm and RVD 2.5-3.5 mm were targeted for direct stenting through diagnostic catheters (4-6F) via radial or femoral approach. Procedural characteristics early in an investigator's experience (28 lesions) were compared with outcomes following experience (26 lesions). Procedure, device and strategy success were realized in 54 (100%), 50 (93%) and 46 (85%) lesions, respectively, with strategy success significantly related to RVD (P = 0.05), lesion location (P = 0.01), and diagnostic catheter size (P = 0.05). Significant improvement in crossing and intervention time and trends toward improvement in device and strategy success, reductions in procedure and radiation time and contrast use were observed.



Direct stenting through diagnostic catheters via radial or femoral approach using the Svelte IDS is feasible and associated with good in-hospital outcomes. This approach offers the attractive option of assessing lesions via diagnostic catheter and, depending upon vessel anatomy and lesion morphology, continuing with ad-hoc interventional treatment using the same diagnostic catheter. Improvements in strategy success and procedural efficiencies, based on operator experience, facilitate catheter downsizing and reduce intervention time, ancillary product use and overall procedure costs.
The Brown Assessment of Beliefs Scale: reliability and validity.

The authors developed and evaluated the reliability and validity of the Brown Assessment of Beliefs Scale, a clinician-administered seven-item scale designed to assess delusions across a wide range of psychiatric disorders.



The authors developed the scale after reviewing the literature on the assessment of delusions. Four raters administered the scale to 20 patients with obsessive-compulsive disorder (OCD), 20 patients with body dysmorphic disorder, and 10 patients with mood disorder with psychotic features. Audiotaped interviews of scale administration conducted by one rater were independently scored by the other raters to evaluate interrater reliability. The scale was administered to 27 patients twice to determine test-retest reliability. Other insight instruments as well as scales that assess symptom severity were administered to assess convergent and discriminant validity. Sensitivity to change was assessed in a multicenter treatment study of sertraline for OCD.



Interrater and test-retest reliability for the total score and individual item scores was excellent, with a high degree of internal consistency. One factor was obtained that accounted for 56% of the variance. Scores on the Brown Assessment of Beliefs Scale were not correlated with symptom severity but were correlated with other measures of insight. The scale was sensitive to change in insight in OCD but was not identical to improvement in severity.



The Brown Assessment of Beliefs Scale is a reliable and valid instrument for assessing delusionality in a number of psychiatric disorders. This scale may help clarify whether delusional and nondelusional variants of disorders constitute the same disorder as well as whether delusionality affects treatment outcome and prognosis.
Coupled dynamics of voltage and calcium in paced cardiac cells.

We investigate numerically and analytically the coupled dynamics of transmembrane voltage and intracellular calcium cycling in paced cardiac cells using a detailed physiological model, and its reduction to a three-dimensional discrete map. The results provide a theoretical framework to interpret various experimentally observed modes of instability ranging from electromechanically concordant and discordant alternans to quasiperiodic oscillations of voltage and calcium.
Self-reported quality of life of 8–12-year-old children with cerebral palsy: a cross-sectional European study

Little is known about the quality of life (QoL) of disabled children. We describe self-reported QoL of children with cerebral palsy, factors that influence it, and how it compares with QoL of the general population.



1174 children aged 8-12 years were randomly selected from eight population-based registers of children with cerebral palsy in six European countries and 743 (63%) agreed to participate; one further region recruited 75 children from multiple sources. Researchers visited these 818 children. 318 (39%) with severe intellectual impairment could not self-report; 500 (61%) reported their QoL using KIDSCREEN, an instrument with scores in ten domains, each with SD=10. Multivariable regression was used to relate QoL to impairments, pain, and sociodemographic characteristics. Comparisons were made with QoL data from the general population.



Impairments were not significantly associated with six KIDSCREEN domains. Comparison of least and most able groups showed that severely limited self-mobility was significantly associated with reduced mean score for physical wellbeing (7.6, 95% CI 2.7-12.4); intellectual impairment with reduced mean for moods and emotions (3.7, 1.5-5.9) and autonomy (3.3, 0.9-5.7); and speech difficulties with reduced mean for relationships with parents (4.5, 1.9-7.1). Pain was common and associated with lower QoL on all domains. Impairments and pain explained up to 3% and 7%, respectively, of variation in QoL. Children with cerebral palsy had similar QoL to children in the general population in all domains except schooling, in which evidence was equivocal, and physical wellbeing, in which comparison was not possible.



Parents can be reassured that most children aged 8-12 years with cerebral palsy will have similar QoL to other children. This finding should guide social and educational policy to ensure that disabled children participate fully in society. Because of its association with QoL, children's pain should be carefully assessed.
Efficacy of inhaled salmeterol in the management of smokers with chronic obstructive pulmonary disease: a single centre randomised, double blind, placebo controlled, crossover study.

The acute response to bronchodilators in patients with chronic obstructive pulmonary disease (COPD) is modest; it has, however, been suggested that these patients may benefit from long term treatment.



To investigate the efficacy of salmeterol in smokers with moderate to severe COPD a double blind, randomised, crossover comparison was performed between salmeterol (50 micrograms twice daily) and placebo in 63 patients with stable COPD (mean age 65 years). Prior to inclusion, all patients had a forced expiratory volume in one second (FEV1) of < 60% of predicted and an improvement in FEV1 of < 15% following 400 micrograms inhaled salbutamol. Patients received four weeks of therapy with each of the treatment regimens. Assessment of efficacy was made with recording of morning and evening peak expiratory flow rates (PEF), respiratory symptoms, and use of rescue salbutamol. FEV1 was measured before and after nebulised salbutamol prior to randomisation and at the end of each treatment period.



Morning PEF values were higher during the salmeterol than during the placebo period, although the mean treatment difference was small (12 l/min (95% confidence limits 6 to 17)). No difference in mean evening PEF values was found. Diurnal variation in PEF, assessed as the difference between the morning PEF and that of the previous evening, was more pronounced during the placebo than during the salmeterol period. The mean spirometric values (including reversibility in FEV1) obtained at the end of the two treatment periods were similar. Compared with placebo, treatment with salmeterol was associated with lower daytime and night time symptom scores and less use of rescue salbutamol both during the day and the night. The patients rated the treatment with salmeterol better than treatment with placebo.



This study shows that, compared with placebo, treatment with salmeterol produces an improvement in respiratory symptoms and morning PEF values in patients with moderate to severe COPD. Treatment with long acting beta agonists may therefore result in an improvement in functional status, even in patients suffering from apparently nonreversible obstructive pulmonary disease.
Efficacy of renal replacement therapy in critically ill patients: a propensity analysis

Although renal replacement therapy (RRT) is a common procedure in critically ill patients with acute kidney injury (AKI), its efficacy remains uncertain. Patients who receive RRT usually have higher mortality rates than those who do not. However, many differences exist in severity patterns between patients with and those without RRT and available results are further confounded by treatment selection bias since no consensus on indications for RRT has been reached so far. Our aim was to account for these biases to accurately assess RRT efficacy, with special attention to RRT timing.



We performed a propensity analysis using data of the French longitudinal prospective multicenter Outcomerea database. Two propensity scores for RRT were built to match patients who received RRT to controls who did not despite having a close probability of receiving the procedure. AKI was defined according to RIFLE criteria. The association between RRT and hospital mortality was examined through multivariate conditional logistic regression analyses to control for residual confounding. Sensitivity analyses were conducted to examine the impact of RRT timing.



Among the 2846 study patients, 545 (19%) received RRT. Crude mortality rates were higher in patients with than in those without RRT (38% vs 17.5%, P < 0.001). After matching and adjustment, RRT was not associated with a reduced hospital mortality. The two propensity models yielded concordant results.



In our study population, RRT failed to reduce hospital mortality. This result emphasizes the need for randomized studies comparing RRT to conservative management in selected ICU patients, with special focus on RRT timing.
Quantifying the treatment efficacy of reverse transcriptase inhibitors: new analyses of clinical data based on within-host modeling

Current measures of the clinical efficacy of antiretroviral therapy (ART) in the treatment of HIV include the change in HIV RNA in the plasma and the gain in CD4 cells.



We propose new measures for evaluating the efficacy of treatment that is based upon combinations of non-nucleoside and nucleoside reverse transcriptase inhibitors. Our efficacy measures are: the CD4 gain per virion eliminated, the potential of CD4 count restoration and the viral reproduction number (R0). These efficacy measures are based upon a theoretical understanding of the impact of treatment on both viral dynamics and the immune reconstitution. Patient data were obtained from longitudinal HIV clinical cohorts.



We found that the CD4 cell gain per virion eliminated ranged from 10(-2) to 600 CD4 cells/virion, the potential of CD4 count restoration ranged from 60 to 1520 CD4 cells/microl, and the basic reproduction number was reduced from an average of 5.1 before therapy to an average of 1.2 after one year of therapy. There was substantial heterogeneity in these efficacy measures among patients with detectable viral replication. We found that many patients who achieved viral suppression did not have high CD4 cell recovery profiles. Our efficacy measures also enabled us to identify a subgroup of patients who were not virally suppressed but had the potential to reach a high CD4 count and/or achieve viral suppression if they had been switched to a more potent regimen.



We show that our new efficacy measures are useful for analyzing the long-term treatment efficacy of combination reverse transcriptase inhibitors and argue that achieving a low R0 does not imply achieving viral suppression.
Effect of Intensive Insulin Therapy Using a Closed-Loop Glycemic Control System in Hepatic Resection Patients

Intensive insulin therapy (IIT) reduces morbidity and mortality in patients in surgical intensive care units. The aim of this study is to assess the effect of IIT using a closed-loop system in hepatectomized patients.  Patients were randomly assigned to receive IIT using a closed-loop system: an artificial pancreas (AP group) or conventional insulin therapy using the sliding-scale method (SS group).  The incidence of surgical-site infection in the AP group was significantly lower than that in the SS group. The length of hospitalization required for patients in the AP group was significantly shorter than that in the SS group.  Total hospital costs for patients in the AP group were significantly lower than for patients in the SS group. IIT using a closed-loop system maintained near-normoglycemia and contributed to a reduction in the incidence of SSI and total hospital costs due to shortened hospitalization.
Effect of eight months of inhaled beclomethasone dipropionate and budesonide on carbohydrate metabolism in adults with asthma.

The safety of high dose inhaled steroids has been a subject of debate. The efficacy and safety of beclomethasone dipropionate and budesonide inhalations were evaluated by measuring their effects on pulmonary function, on the hypothalamic-pituitary-adrenocortical axis, and on carbohydrate metabolism in adults with unstable asthma.



Fifteen adults with unstable asthma and 15 healthy controls were studied. Eight patients were treated with beclomethasone dipropionate in initially high (2 mg/day for five months) and subsequently lower (1 mg/day for three months) doses. Seven patients were treated with budesonide at doses of 1.6 mg/day for five months followed by 0.8 mg/day for three months. Blood glucose and serum insulin were measured in an oral glucose tolerance test and plasma cortisol in an adrenocorticotrophic hormone test. The antiasthmatic effect of treatment was evaluated by measuring peak morning expiratory flow rates and forced expiratory volume in one second (FEV1).



The FEV1 increased significantly after one month of treatment (medians 88% v 96%, p < 0.01), and nocturnal symptoms disappeared within two weeks of treatment in both groups. At one month, the high dose significantly decreased serum insulin concentrations as calculated from the areas under the incremental two hours curves in the glucose tolerance test. The decrease was 59% for beclomethasone dipropionate (medians 76 v 31 mU/l/h, p < 0.005) and 42% for budesonide (medians 79 v 46 mU/l/h, p < 0.01). The median areas at five and eight months were intermediate for both drugs. No significant differences were found when the five and eight month values were compared either with the baseline or with one month values. The difference between the baseline values of both groups and the respective values in healthy controls was significant (medians 79 v 49 mU/l/h, p < 0.01). The one month values for the patients and control subjects were similar. Paralleling the changes for insulin, the area under the incremental two hour blood glucose curve decreased significantly (medians 1.4 v 0.4 mmol/l/h, p < 0.05) during the first month of treatment. The five and eight month values were intermediate (medians 0.8 and 0.7 mmol/l/h, respectively). These changes were not significant compared with the baseline or the one month areas. Similar changes were seen in both treatment groups. Neither treatment had any significant effect on plasma cortisol in the one hour adrenocorticotrophic hormone test.



In patients stressed by uncontrolled asthma, the antiasthmatic effect of high dose beclomethasone dipropionate and budesonide was accompanied by a significant initial decrease in insulin resistance with a parallel improvement in glucose tolerance. During prolonged treatment a small increase in insulin sensitivity was found. The overall effect of beclomethasone dipropionate and budesonide inhalations on carbohydrate metabolism may be beneficial in patients with uncontrolled asthma.
Risk factors for acquiring functional and cognitive disabilities during admission to a PICU*.

To describe the risk factors for acquiring functional or cognitive disabilities during admission to a PICU.



Retrospective analysis of a multicenter PICU database.



Twenty-four PICUs in the Virtual PICU Performance System network from January 1, 2009, through December 31, 2010.



Consecutive patients, who are 1 month to 18 years old, who survived to discharge.



None.



Primary outcomes were acquired global functional disability and cognitive disability during admission to a PICU, measured by change in Pediatric Overall Performance Category or in Pediatric Cerebral Performance Category scores, respectively. The primary analysis cohort consisted of 29,352 admissions to the 24 Virtual PICU Performance System sites which collected the main outcome variables. Respectively, 10.3% and 3.4% of the cohort acquired global functional or cognitive disability. Trauma diagnosis (odds ratio, 4.50; 95% CI, 3.83-5.29; odds ratio, 3.91; 95% CI, 3.07-4.98), unscheduled admission to the PICU (odds ratio, 2.67; 95% CI, 2.27-3.12; odds ratio, 1.52; 95% CI, 1.16-2.00), highest risk of mortality category (odds ratio, 1.19; 95% CI, 1.02-1.39; odds ratio, 2.70; 95% CI, 2.15-3.40), oncologic primary diagnoses (odds ratio, 5.61; 95% CI, 4.56-6.91; odds ratio, 4.30; 95% CI, 2.97-6.24), and neurologic primary diagnoses (odds ratio, 2.04, 95% CI, 1.70-2.44; odds ratio, 4.29, 95% CI, 3.18-5.78) were independently associated with acquiring both functional and cognitive disability. Intervention risk factors for acquiring both functional and cognitive disability included invasive mechanical ventilation (odds ratio, 1.79; 95% CI, 1.60-2.00; odds ratio, 2.83; 95% CI, 2.36-3.39), renal replacement therapy (odds ratio, 2.43; 95% CI, 1.73-3.42; odds ratio, 1.76, 95% CI, 1.08-2.85), cardiopulmonary resuscitation (odds ratio, 1.91; 95% CI, 1.24-2.95; odds ratio, 1.81; 95% CI, 1.02-3.23), and extracorporeal membrane oxygenation (odds ratio, 7.40, 95% CI, 4.10-13.36; odds ratio, 14.04, 95% CI, 7.51-26.26).



We identified a subset of patients whose potential for acquiring global functional and cognitive disability during admission to the PICU is high. This population may benefit from interventions that could mitigate this risk and from focused follow-up after discharge from the PICU.
Behavioural activation v. antidepressant medication for treating depression in Iran: randomised trial.

Behavioural activation might be a viable alternative to antidepressant medication for major depressive disorder.



To compare the effectiveness of behavioural activation and treatment as usual (TAU, antidepressant medication) for major depressive disorder in routine clinical practice in Iran.



Patients with major depressive disorder (n = 100) were randomised to 16 sessions of behavioural activation (n = 50) or antidepressant medication (n = 50) (IRCT138807192573N1). The main outcome was depression, measured with the Beck Depression Inventory (BDI) and the Hamilton Rating Scale for Depression (HRSD), assessed at 0, 4, 13 and 49 weeks.



Symptom reduction was greater in the behavioural activation group than in the TAU group on both the BDI and the HRSD at 13 and 49 weeks in multilevel analysis. Baseline depression severity was a moderator, with relatively better effects for behavioural activation in individuals who were more severely depressed. Also, there was better retention in the behavioural activation than in the TAU group.



Behavioural activation is a viable and effective treatment for people with major depressive disorder, especially for those who are more severely depressed, and it can successfully be disseminated into routine practice settings in a non-Western country such as Iran.
Prevalent immunosuppressive strategies in liver transplantation for hepatitis C: results of a multi-center international survey.

To determine current immunosuppression regimens and strategies for acute cellular rejection in hepatitis C virus (HCV) patients after liver transplantation (LT), questionnaires were sent to 264 LT programs worldwide. Surveys from 81 programs were reviewed. In 27 centers (33.8%) the immunosuppression protocol used in HCV differed from non-HCV patients. Tacrolimus-based immunosuppression is utilized in 70 centers (86.42%). Triple therapy using tacrolimus, mycophenolate mofetil and steroids is the most common regimen (41%). Six programs (7.4%) use steroid-free protocols. In nine centers (11%) steroids are discontinued within a week, 56% within 3 months, and 98% within the first year. At 75% of centers, mild rejection is treated by increasing baseline immunosuppression. Moderate rejection is treated by increasing baseline immunosuppression in 38% of centers, steroid bolus in 44%, and either in 16%. For severe rejection, 46% of centers give bolus steroid, and 16% administer antibodies. Among respondents, non-US programs use significantly more cyclosporine than US programs (35.6% vs. 2.8%, P<0.001). Duration of steroid therapy is significantly shorter in US programs than non-US (10.8 vs. 29.4 weeks, P<0.001). There is no consensus regarding the best immunosuppressive regimen and rejection treatments in HCV patients after LT. Our results reveal the most prevalent management practices in this difficult group of patients.