nils-herrmann/clean_scirepeval huggingface dataset:
Long-term effects of fenofibrate on VLDL and HDL subspecies in participants with type 2 diabetes mellitus

An incorrect conversion factor was used by the authors resulting in values given in g/l being ten times higher than they should have been. The corrected sections of Tables 1, 2, 3, 4 are reproduced below. In addition there are two text corrections: The last paragraph of the Abstract should have read: Conclusions/interpretation Fenofibrate markedly reduced large VLDL particles and produced a clear shift in HDL subspecies towards smaller particles. The HDL3-C increase in conjunction with unchanged apoA-I levels is a dilemma with regard to cardiovascular disease. The last sentence of the subsection on ‘Impact of homocysteine levels on HDL’ in the Results should have read: In patients with low homocysteine levels (n=42), HDL-C and apoA-I levels were slightly increased by fenofibrate (Δ=0.05 mmol/l for HDL-C and Δ=0.034 g/l for apoA-I), whereas in patients with high homocysteine levels (n=42) HDL-C and apoA-I levels decreased (Δ=−0.04 mmol/l for HDL-C and Δ=−0.014 g/l for apoA-I) (p=0.028 for both the differences in ΔHDL-C and ΔapoA-I between the low and high homocysteine groups). Diabetologia (2007) 50:2611–2613 DOI 10.1007/s00125-007-0845-3
C-peptide levels and insulin independence following autologous nonmyeloablative hematopoietic stem cell transplantation in newly diagnosed type 1 diabetes mellitus.

In 2007, the effects of the autologous nonmyeloablative hematopoietic stem cell transplantation (HSCT) in 15 patients with type 1 diabetes mellitus (DM) were reported. Most patients became insulin free with normal levels of glycated hemoglobin A(1c) (HbA(1c)) during a mean 18.8-month follow-up. To investigate if this effect was due to preservation of beta-cell mass, continued monitoring was performed of C-peptide levels after stem cell transplantation in the 15 original and 8 additional patients.



To determine C-peptide levels after autologous nonmyeloablative HSCT in patients with newly diagnosed type 1 DM during a longer follow-up.



A prospective phase 1/2 study of 23 patients with type 1 DM (aged 13-31 years) diagnosed in the previous 6 weeks by clinical findings with hyperglycemia and confirmed by measurement of serum levels of anti-glutamic acid decarboxylase antibodies. Enrollment was November 2003-April 2008, with follow-up until December 2008 at the Bone Marrow Transplantation Unit of the School of Medicine of Ribeirão Preto, Ribeirão Preto, Brazil. Hematopoietic stem cells were mobilized via the 2007 protocol.



C-peptide levels measured during the mixed-meal tolerance test, before, and at different times following HSCT. Secondary end points included morbidity and mortality from transplantation, temporal changes in exogenous insulin requirements, and serum levels of HbA(1c).



During a 7- to 58-month follow-up (mean, 29.8 months; median, 30 months), 20 patients without previous ketoacidosis and not receiving corticosteroids during the preparative regimen became insulin free. Twelve patients maintained this status for a mean 31 months (range, 14-52 months) and 8 patients relapsed and resumed insulin use at low dose (0.1-0.3 IU/kg). In the continuous insulin-independent group, HbA(1c) levels were less than 7.0% and mean (SE) area under the curve (AUC) of C-peptide levels increased significantly from 225.0 (75.2) ng/mL per 2 hours pretransplantation to 785.4 (90.3) ng/mL per 2 hours at 24 months posttransplantation (P < .001) and to 728.1 (144.4) ng/mL per 2 hours at 36 months (P = .001). In the transient insulin-independent group, mean (SE) AUC of C-peptide levels also increased from 148.9 (75.2) ng/mL per 2 hours pretransplantation to 546.8 (96.9) ng/mL per 2 hours at 36 months (P = .001), which was sustained at 48 months. In this group, 2 patients regained insulin independence after treatment with sitagliptin, which was associated with increase in C-peptide levels. Two patients developed bilateral nosocomial pneumonia, 3 patients developed late endocrine dysfunction, and 9 patients developed oligospermia. There was no mortality.



After a mean follow-up of 29.8 months following autologous nonmyeloablative HSCT in patients with newly diagnosed type 1 DM, C-peptide levels increased significantly and the majority of patients achieved insulin independence with good glycemic control.
Growth in Prepubertal Children With Cystic Fibrosis Treated With Ivacaftor.

Cystic fibrosis (CF) is known for its impact on the lung and pancreas of individuals; however, impaired growth is also a common complication. We hypothesized that targeting the biological defect in the CF transmembrane conductance regulator (CFTR) protein may affect growth outcomes.



In this post hoc analysis, we assessed linear growth and weight in 83 children (aged 6-11 years) enrolled in 2 clinical trials, the longitudinal-observation GOAL study and the placebo-controlled ENVISION study, to evaluate the effects of ivacaftor, a CFTR potentiator. We calculated height and weight z scores and height and weight growth velocities (GVs).



In ivacaftor-treated children in GOAL, height and weight z scores increased significantly from baseline to 6 months (increases of 0.1 [P < .05] and 0.26 [P < .0001], respectively); height GV increased significantly from 3 to 6 months (2.10-cm/year increase; P < .01). In ivacaftor-treated children in ENVISION, height and weight z scores increased significantly from baseline to 48 weeks (increases of 0.17 [P < .001] and 0.35 [P < .001], respectively). Height and weight GVs from baseline to 48 weeks were also significantly higher with ivacaftor than with placebo (differences of 1.08 cm/year [P < .05] and 3.11 kg/year [P < .001], respectively).



Ivacaftor treatment in prepubescent children may help to address short stature and altered GV in children with CF; results from these analyses support the existence of an intrinsic defect in the growth of children with CF that may be ameliorated by CFTR modulation.
Identification of biomarkers that predict response to treatment of lupus nephritis with mycophenolate mofetil or pulse cyclophosphamide.

There is a need to identify clinical characteristics and/or biomarkers that can predict treatment outcome in lupus nephritis. To this end, we utilized data from the Aspreva Lupus Management Study to identify possible baseline and early predictors of renal response to mycophenolate mofetil (MMF) or intravenous (IV) cyclophosphamide (CYC).



Patients with class III-V lupus nephritis were randomized to MMF or IV CYC. We assessed predictors of renal response, including baseline demographic, clinical, laboratory, and histologic characteristics, as well as early clinical and laboratory data, obtained within the first 2 months of therapy. Odds ratios (ORs) and 95% confidence intervals for renal response were calculated for each putative predictor.



Normalization of C3, C4, or both by week 8 was strongly predictive of renal response at week 24 (ORs 2.5, 2.6, and 2.9, respectively; P < 0.05). Reduction in proteinuria by ≥25% by week 8 was predictive of renal response at week 24 (OR 3.2, P < 0.05). Reduction in anti-double-stranded DNA (anti-dsDNA) by week 8 was not predictive of renal response. Only 3 baseline characteristics (C4 level, time since diagnosis of lupus nephritis, and estimated glomerular filtration rate [GFR]) were predictive of renal response; the remaining characteristics (age, age at lupus nephritis onset, time since diagnosis of systemic lupus erythematosus, sex, histopathologic class, anti-dsDNA antibody level, C3 level, level of proteinuria, and use of angiotensin-converting enzyme inhibitors, statins, or hydroxychloroquine) were not.



This study demonstrates that baseline C4 level, time since diagnosis of lupus nephritis, baseline estimated GFR, early normalization of complement, and reduction in proteinuria independently predict renal response to therapy at 6 months.
Measuring multitasking behavior with activity-based metrics

Multitasking is the result of time allocation decisions made by individuals faced with multiple tasks. Multitasking research is important in order to improve the design of systems and applications. Since people typically use computers to perform multiple tasks at the same time, insights into this type of behavior can help develop better systems and ideal types of computer environments for modern multitasking users. In this paper, we define multitasking based on the principles of task independence and performance concurrency and develop a set of metrics for computer-based multitasking. The theoretical foundation of this metric development effort stems from an application of key principles of Activity Theory and a systematic analysis of computer usage from the perspective of the user, the task and the technology. The proposed metrics, which range from a lean dichotomous variable to a richer measure based on switches, were validated with data from a sample of users who self-reported their activities during a computer usage session. This set of metrics can be used to establish a conceptual and methodological foundation for future multitasking studies.
Subcutaneous golimumab maintains clinical response in patients with moderate-to-severe ulcerative colitis.

Subcutaneous golimumab, a fully human monoclonal antibody to tumor necrosis factor-α (TNFα), was evaluated as maintenance therapy in TNFα antagonist-naive adults with moderate-to-severe active ulcerative colitis, despite conventional therapy, who responded to golimumab induction therapy.



We performed a phase 3, double-blind trial of patients who completed golimumab induction trials (Program of Ulcerative Colitis Research Studies Utilizing an Investigational Treatment, eg, PURSUIT). Patients who responded to induction therapy with golimumab (n = 464) were assigned randomly to groups given placebo or injections of 50 or 100 mg golimumab every 4 weeks through week 52. Patients who responded to placebo in the induction study continued to receive placebo. Nonresponders in the induction study received 100 mg golimumab. The primary end point was clinical response maintained through week 54; secondary end points included clinical remission and mucosal healing at both weeks 30 and 54.



Clinical response was maintained through week 54 in 47.0% of patients receiving 50 mg golimumab, 49.7% of patients receiving 100 mg golimumab, and 31.2% of patients receiving placebo (P = .010 and P < .001, respectively). At weeks 30 and 54, a higher percentage of patients who received 100 mg golimumab were in clinical remission and had mucosal healing (27.8% and 42.4%) than patients given placebo (15.6% and 26.6%; P = .004 and P = .002, respectively) or 50 mg golimumab (23.2% and 41.7%, respectively). Percentages of serious adverse events were 7.7%, 8.4%, and 14.3% among patients given placebo, 50 mg, or 100 mg golimumab, respectively; percentages of serious infections were 1.9%, 3.2%, and 3.2%, respectively. Among all patients given golimumab in the study, 3 died (from sepsis, tuberculosis, and cardiac failure, all in patients who received 100 mg golimumab) and 4 developed active tuberculosis.



Golimumab (50 mg or 100 mg) maintained clinical response through week 54 in patients who responded to induction therapy with golimumab and had moderate-to-severe active ulcerative colitis; patients who received 100 mg golimumab had clinical remission and mucosal healing at weeks 30 and 54. Safety was consistent with that reported for other TNFα antagonists and golimumab in other approved indications.
Context-aware multimedia services in a pervasive environment: the Daidalos approach

There is a clear trend towards making multimedia applications context-aware so as to customize them by taking into account any collection of information which may be relevant, such as e.g. user location. However, current multimedia services are dominated by IMS, which is seen as a service platform that uses the SIP protocol to access all services that the Internet can provide. In this paper, we describe the Daidalos approach on making IMS based multi-media services context-aware. We also demonstrate, how generic sensor networks can be integrated into the context management system of our platform thus enabling sensor network detected events to influence behavior of context-aware multimedia applications.
Haemodynamic changes during early bereavement: potential contribution to increased cardiovascular risk.

bereavement is associated with increased cardiovascular risk, particularly in surviving spouses and parents, however the mechanism is not well understood due to limited studies. The purpose of this study was to evaluate haemodynamic changes (blood pressure (BP) and heart rate (HR)), that may contribute to increased cardiac risk in early bereavement.



we enrolled 80 bereaved individuals and 80 non-bereaved as a reference group. Twenty-four hour ambulatory blood pressure monitoring was performed within two weeks (acute assessment) and at six months following bereavement.



compared to the non-bereaved, the acutely bereaved had higher 24-hour systolic BP (mean (SE) 130.3 (1.5) vs 127.5 (1.4)mmHg, p=0.03), higher daytime systolic BP (135.6 (1.5) vs 131.6 (1.4)mmHg, p=0.02) and higher daytime systolic load (median % 39.0 vs 29.3, p=0.02). By six months the BP of the bereaved tended to be lower than acute measures. This difference was significant amongst those not taking BP lowering medications for 24-hour systolic BP (126.5 (2.4) vs 129.7 (2.3)mmHg, p=0.04), daytime systolic BP (129.8 (2.1) vs 133.9 (2.0)mmHg, p=0.01) and daytime diastolic pressure (76.7 (1.0) vs 78.9 (0.9)mmHg, p=0.03). Twenty-four hour heart rate was also higher acutely in the bereaved compared with the reference group (74.0 (1.2) vs 71.7 (0.9) b/min, p=0.02); at six months heart rate in the bereaved had fallen to non-bereaved levels (70.4 (0.09), p=0.02).



early bereavement is associated with increased systolic blood pressure and heart rate. These haemodynamic changes may contribute to a time-limited increase in cardiovascular risk.
Do pancrelipase delayed-release capsules have a protective role against nonalcoholic fatty liver disease after pancreatoduodenectomy in patients with pancreatic cancer? A randomized controlled trial.

The aim of this randomized controlled trial (RCT) was to investigate whether pancrelipase protects against nonalcoholic fatty liver disease (NAFLD) development after pancreatoduodenectomy in patients with pancreatic cancer better than conventional pancreatic enzyme supplementation.



A total of 57 patients were randomly assigned to the study group (n = 29; pancrelipase replacement therapy) or the control group (n = 28; conventional pancreatic enzyme supplementation). NAFLD was defined as a liver-to-spleen attenuation ratio less than 0.9 on CT. Clinical and laboratory findings were also assessed.



NAFLD was observed in 6/29 patients (21%) in the study group, and 11/28 patients (39%) in the control group, but this was not a statistically significant difference. In the control group, crossover to pancrelipase replacement therapy upon NAFLD diagnosis produced improvement in five out of 10 patients. Multivariate analysis showed that advanced age and extended resection were independent risk factors for NAFLD development.



This RCT did not show a significant protective effect of pancrelipase replacement therapy over conventional pancreatic enzyme supplementation on NAFLD development after pancreatoduodenectomy for pancreatic cancer. Further studies are clearly required to investigate the etiology of and new therapeutic strategies for treatment-resistant NAFLD (UMIN 000019817).
Treatment of multiple sclerosis with interferon beta in clinical practice: 2-year follow-up data from the South Italy Mobile MRI Project

This follow-up study assessed the 2-year clinical and magnetic resonance imaging (MRI) outcomes of patients with multiple sclerosis (MS) originally enrolled in an MRI study conducted at eight centres in south Italy (the South Italy Mobile MRI Project). Of the 597 MS patients recruited at baseline, 391 returned for the follow-up study. Of these, 363 provided 2-year clinical and MRI follow-up data, and 215 were still undergoing treatment with one of four interferon beta regimens: Avonex, 30 mcg intramuscularly once weekly; Betaferon, 250 mcg subcutaneously (sc) every other day; Rebif 22 mcg sc three times weekly (tiw; Rebif 22); or Rebif 44 mcg sc tiw (Rebif 44). Over the 2-year follow-up period, patients receiving the higher dose of Rebif were more likely to remain free from relapses [odds ratio (OR) = 2.23] and from developing both new T2 (OR = 0.15) and new T1 black hole lesions (OR = 0.22), when compared with patients in the Avonex group. Despite some limitations in the trial design, the results from this follow-up study provide helpful clinical and MRI data on the efficacy of interferon beta regimens in MS patients treated in the clinical setting.
Lutein + zeaxanthin and omega-3 fatty acids for age-related macular degeneration: the Age-Related Eye Disease Study 2 (AREDS2) randomized clinical trial.

Oral supplementation with the Age-Related Eye Disease Study (AREDS) formulation (antioxidant vitamins C and E, beta carotene, and zinc) has been shown to reduce the risk of progression to advanced age-related macular degeneration (AMD). Observational data suggest that increased dietary intake of lutein + zeaxanthin (carotenoids), omega-3 long-chain polyunsaturated fatty acids (docosahexaenoic acid [DHA] + eicosapentaenoic acid [EPA]), or both might further reduce this risk.



To determine whether adding lutein + zeaxanthin, DHA + EPA, or both to the AREDS formulation decreases the risk of developing advanced AMD and to evaluate the effect of eliminating beta carotene, lowering zinc doses, or both in the AREDS formulation.



The Age-Related Eye Disease Study 2 (AREDS2), a multicenter, randomized, double-masked, placebo-controlled phase 3 study with a 2 × 2 factorial design, conducted in 2006-2012 and enrolling 4203 participants aged 50 to 85 years at risk for progression to advanced AMD with bilateral large drusen or large drusen in 1 eye and advanced AMD in the fellow eye.



Participants were randomized to receive lutein (10 mg) + zeaxanthin (2 mg), DHA (350 mg) + EPA (650 mg), lutein + zeaxanthin and DHA + EPA, or placebo. All participants were also asked to take the original AREDS formulation or accept a secondary randomization to 4 variations of the AREDS formulation, including elimination of beta carotene, lowering of zinc dose, or both.



Development of advanced AMD. The unit of analyses used was by eye.



Median follow-up was 5 years, with 1940 study eyes (1608 participants) progressing to advanced AMD. Kaplan-Meier probabilities of progression to advanced AMD by 5 years were 31% (493 eyes [406 participants]) for placebo, 29% (468 eyes [399 participants]) for lutein + zeaxanthin, 31% (507 eyes [416 participants]) for DHA + EPA, and 30% (472 eyes [387 participants]) for lutein + zeaxanthin and DHA + EPA. Comparison with placebo in the primary analyses demonstrated no statistically significant reduction in progression to advanced AMD (hazard ratio [HR], 0.90 [98.7% CI, 0.76-1.07]; P = .12 for lutein + zeaxanthin; 0.97 [98.7% CI, 0.82-1.16]; P = .70 for DHA + EPA; 0.89 [98.7% CI, 0.75-1.06]; P = .10 for lutein + zeaxanthin and DHA + EPA). There was no apparent effect of beta carotene elimination or lower-dose zinc on progression to advanced AMD. More lung cancers were noted in the beta carotene vs no beta carotene group (23 [2.0%] vs 11 [0.9%], nominal P = .04), mostly in former smokers.



Addition of lutein + zeaxanthin, DHA + EPA, or both to the AREDS formulation in primary analyses did not further reduce risk of progression to advanced AMD. However, because of potential increased incidence of lung cancer in former smokers, lutein + zeaxanthin could be an appropriate carotenoid substitute in the AREDS formulation.
The impact of evidence-based guideline dissemination for the assessment and treatment of major depression in a managed behavioral health care organization

This study tests whether a managed behavioral health care organization can influence adherence to practice guidelines for the treatment of major depression in a randomized trial of guideline dissemination. Guidelines were disseminated to mental health clinicians (N=443) under one of three conditions: (1) a general mailing of guidelines to clinicians, (2) a mailing in which guidelines were targeted to a patient starting treatment with the clinician, and (3) no mailing of guidelines. The results showed no effects of guideline dissemination as measured by self-report of patients and clinicians and through episode characteristics derived from claims data, despite sentinel effects. Results also showed high rates of clinician-reported guideline adherence that were not detected in the claims data, indicating significant undertreatment of depression. Results suggest that mental health systems must look to other dissemination strategies to improve adherence to standards of care and raise the performance of independent practicing clinicians
Transcatheter aortic valve implantation: early results of the FRANCE (FRench Aortic National CoreValve and Edwards) registry.

Transcatheter aortic valve implantation is a therapeutic alternative for high-surgical-risk patients with severe symptomatic aortic stenosis. Two models of prosthesis are currently commercialized in France, which can be implanted either via a transarterial or a transapical approach. The aim of the study was to evaluate in a national French registry the early safety and efficacy of transcatheter aortic valve replacement (AVR) using either the Edwards SAPIEN™ or CoreValve™ in high-surgical-risk patients with severe aortic stenosis.



The multicentre national registry was conducted in 16 centres between February 2009 and June 2009, under the authority of the French Societies of Cardiology and Thoracic and Cardio-Vascular Surgery. The primary endpoint was mortality at 1 month. Two hundred and forty-four high-surgical-risk patients (logistic EuroSCORE ≥20%, STS ≥10%, or contra-indication to AVR) were enrolled. Mean age was 82 ± 7 years and 43.9% were female. Edwards SAPIEN and CoreValve were implanted in 68 and 32% of patients, respectively. The approaches used were transarterial (transfemoral: 66%; subclavian: 5%) or transapical in 29%. Device success rate was 98.3% and 30-day mortality was 12.7%. Severe complications included stroke (3.6%), tamponade (2%), acute coronary occlusion (1.2%), and vascular complications (7.3%). Pacemaker was required in 11.8%. At 1 month, 88% of patients were in NYHA class II or less.



This prospective registry reflects the real-life experience of transcatheter aortic valve implantation in high-risk elderly patients in France. The early results are satisfactory in terms of feasibility, short-term haemodynamic and functional improvement, and safety. Longer term follow-up will be further assessed.
Family-focused treatment versus individual treatment for bipolar disorder: results of a randomized clinical trial.

Recently hospitalized bipolar, manic patients (N = 53) were randomly assigned to a 9-month, manual-based, family-focused psychoeducational therapy (n = 28) or to an individually focused patient treatment (n = 25). All patients received concurrent treatment with mood-stabilizing medications. Structured follow-up assessments were conducted at 3-month intervals for a 1-year period ofactive treatment and a 1-year period of posttreatment follow-up. Compared with patients in individual therapy, those in family-focused treatment were less likely to be rehospitalized during the 2-year study period. Patients in family treatment also experienced fewer mood disorder relapses over the 2 years, although they did not differ from patients in individual treatment in their likelihood of a first relapse. Results suggest that family psychoeducational treatment is a useful adjunct to pharmacotherapy in decreasing the risk of relapse and hospitalization frequently associated with bipolar disorder.