nils-herrmann/clean_scirepeval huggingface dataset:
Comparison of the L10M consolidation regimen to an alternative regimen including escalating methotrexate/L-asparaginase for adult acute lymphoblastic leukemia: a Southwest Oncology Group Study

The effectiveness of intensive post-remission chemotherapy regimens for adult patients with acute lymphoblastic leukemia (ALL) is limited by both a high rate of disease recurrence and a substantial incidence of treatment toxicity. To evaluate a potentially more effective and less toxic approach, we conducted a multicenter phase III trial of consolidation therapies comparing the standard L10M regimen with one combining the brief, intensive L17M regimen and escalating methotrexate (MTX) and L-asparaginase (L-asp). Patients over age 15 with previously untreated ALL were eligible. Induction therapy included vincristine, prednisone, doxorubicin, cyclophosphamide and intrathecal methotrexate administered over 36 days. Patients who achieved complete remission (CR) were randomized to receive consolidation with either the L10M regimen or with DAT (daunomycin, cytosine arabinoside, 6-thioguanine) and escalating MTX and L-asp. The randomization was stratified by age, WBC and Ph chromosome status. Maintenance therapy was the same in both arms. Of 353 eligible patients, 218 (62%) achieved CR and 195 were randomized. The treatment arms did not differ significantly with respect to disease-free survival (DFS; P = 0.46) or overall survival (P = 0.39). Estimated DFS at 5 years was 32% (95% confidence interval (CI) 23–42%) in the L10M arm and 25% (95% CI 16–33%) in the DAT/MTX/L-asp arm. In each arm, 4% of patients died of toxicities (infection in all but one case). Infections and nausea/vomiting were somewhat more common in the L10M arm (occurring in 68% and 53% of patients respectively) than the DAT/MTX/L-asp arm (56% and 33%). The DAT/MTX/L-asp consolidation regimen was associated with some reduction in nonfatal toxicities, but no significant improvement in DFS, overall survival or non-relapse mortality when compared to the standard L10M regimen.
Immunostimulatory sequences regulate interferon-inducible genes but not allergic airway responses.

1018 ISS is a synthetic oligonucleotide containing immunostimulatory CpG motifs. In animal studies, 1018 ISS effectively inhibited Th2-mediated lung inflammation, including eosinophil infiltration, and airway hyperresponsiveness.



To evaluate whether 1018 ISS has activity in subjects with allergic asthma.



Forty subjects (n = 21, 1018 ISS; n = 19, placebo) were enrolled in a randomized, double-blind, placebo-controlled, parallel-group study to examine safety, pharmacologic activity, and efficacy of 1018 ISS on allergen-induced airway responses. Subjects received 36 mg of 1018 ISS or placebo by nebulization weekly for 4 wk.



Allergen inhalation challenge was performed 24 h after the 2nd and 4th doses to measure the early and late fall in FEV(1). Sputum cells and peripheral blood mononuclear cells were collected before and after dosing, and gene expression was measured by quantitative polymerase chain reaction.



Treatment with 1018 ISS significantly increased expression of interferon (IFN)-gamma and IFN-inducible genes, such as IFN-gamma-inducible 10 kD protein (IP10), monokine induced by IFN-gamma (MIG), IFN-stimulated gene (ISG)-54, monocyte chemotactic protein (MCP)-1, and MCP-2 from cells collected postdose (p < 0.05). There was no attenuation of the early or late decrease in FEV(1) after 1018 ISS compared with placebo, nor a reduction in allergen-induced sputum eosinophils or Th2-related gene expression measured in sputum cells.



This study demonstrated that 1018 ISS is safe and pharmacologically active in the respiratory tract of asthmatics but, at this dose regimen, did not inhibit a fall in FEV(1) or other key features of the response to inhaled allergen challenge. This suggests that induction of IFN and IFN-inducible genes alone is not sufficient to inhibit allergen-induced responses in asthmatic subjects.
Two-Dimensional Spatial Positioning as a Means for Reflection in Design

In the realm of computer support for design, developers have focused primarily on power and expressiveness that are important in framing a design solution. They assume that design is a series of calculated steps that lead to a clearly specified goal. The problem with this focus is that the resulting tools hinder the very process that is critical in early phases of a design task; the reflection-in-action process . In the early phases, what is required as the most important ingredient for a design tool is the ability to interact in ways that require as little commitment as possible. This aspect is most evident in domains where two dimensions play a role, such as sketching in architecture. Surprisingly, it is equally true in linear domains such as writing. In this paper, we present our approach of using two-dimensional positioning of objects as a means for reflection in the early phases of a design task. Taking writing as an example, the ART (Amplifying Representational Talkback) system uses two dimensional positioning to support the early stages of the writing task. An eye-tracking user study illustrates important issues in the domain of computer support for design.
Echocardiographic findings in kidney transplanted Type 1 (insulin-dependent) diabetic patients with and without a pancreas transplant

Echocardiography with Doppler recordings was carried out in 14 Type 1 (insulin-dependent) diabetic recipients of pancreas and kidney transplants and in 14 Type 1 diabetic kidney transplanted control patients, matched for age, sex, duration of diabetes, extent of other late complications, time since transplantation, dose of prednisolone, and renal function. HbA1c was 5.5±0.6 vs 8.7+1.4% (pancreas transplanted vs kidney only). Both groups had a slight increase in interventricular septum thickness. Left ventricular mass was equal. The ejection fraction as a measure of systolic function was normal and equal, 0.71±0.05 vs 0.69±0.07. Diastolic function was also equal in two out of three parameters, isovolumic relaxation time and deceleration time. The A/E ratio, however, tended to be lower in the pancreas transplanted group, 0.94±0.20 vs 1.06±0.18 (p=0.04). This indicates more frequent occurrence of impaired diastolic filling in the recipients of kidney only. Follow-up will show whether diastolic dysfunction increases and may be related to the increased cardiovascular mortality in kidney transplanted Type 1 diabetic patients.
Course of fatigue in women receiving chemotherapy and/or radiotherapy for early stage breast cancer.

Although much has been learned about the complication of fatigue during breast cancer treatment, the possibility that there are differences across treatment modalities in breast cancer patients' experience of fatigue has not yet been established. In this study, fatigue was assessed in 134 women receiving chemotherapy and radiotherapy or radiotherapy only for early stage breast cancer. Comparisons of fatigue during initial treatment indicated that women who received chemotherapy reported greater fatigue severity and disruptiveness than women receiving radiotherapy. Women not pre-treated with chemotherapy experienced increased fatigue over the course of radiotherapy. Results confirmed predictions that fatigue in women with early stage breast cancer differs as a function of the type of treatment and sequencing of treatment. Findings indicating increases in fatigue during radiotherapy only among women not pretreated with chemotherapy suggest a response shift, or a change in internal standards, in women's perceptions of fatigue as a function of prior chemotherapy treatment.
Objective and subjective image quality of liver parenchyma and hepatic metastases with virtual monoenergetic dual-source dual-energy CT reconstructions: an analysis in patients with gastrointestinal stromal tumor.

To compare in dual-energy CT (DECT) conventionally reconstructed polyenergetic images (PEI) at 120 kVp to virtual monoenergetic images (MEI) at different kiloelectron volt (keV) levels for evaluation of liver and gastrointestinal stromal tumor (GIST) hepatic metastases with regard to objective (IQob) and subjective image quality (IQsub) assessed by two readers of varying experience. Image quality was correlated to patient size and compared between PEI and MEI.



From 50 examinations of 17 GIST patients (12 with hepatic metastases) undergoing abdominal dual-source DECT for staging, therapy monitoring or follow-up, PEI and nine MEI in 10-keV intervals from 40 to 120 keV were reconstructed. Liver contrast-to-noise ratios (CNR) and metastasis-to-liver ratios were calculated. MEI reconstructions with the highest IQob were compared to PEI for IQsub by one experienced reader (ER) and one inexperienced reader (IR). Patients' diameters were correlated to IQob and IQsub ratings.



MEI at 70 keV had the highest IQob with equal liver CNR and metastasis-to-liver ratio compared to PEI. The ER rated 70-keV MEI and PEI equally high (median 4), whereas the IR rated IQsub best in 70-keV MEI (median 5). Unlike in PEI, IQsub ratings in 70-keV MEI were not correlated to patient size.



MEI at 70 keV provided an IQob equivalent to PEI. Regarding the IR, IQsub was improved in 70-keV MEI compared to PEI and less dependent on patient size. Therefore, IRs might improve their diagnostic confidence in the assessment of hepatic GIST metastases by evaluating MEI reconstructions at 70 keV.
The Level of Anxiety and Depression in Dialysis Patients Undertaking Regular Physical Exercise Training--a Preliminary Study.

The aim of the study was to evaluate the effects of a six-month physical training undertaken by haemodialysis (HD) patients, on the depression and anxiety.



Patients with end stage renal disease (ESRD) were recruited from the dialysis station at the Department of Nephrology and Transplantation Medicine in Wroclaw. Physical training took place at the beginning of the first 4-hours of dialysis, three times a week for six months. A personal questionnaire, Beck Depression Inventory (BDI) and State-Trait Anxiety Inventory (STAI) were used in the study.



A total of 28 patients completed the study: 20 were randomised to endurance training and 8 were randomised to resistance training. Statistical analysis of depression and anxiety at the initial (t1) and final examination (t2) indicated a significant reduction in depression and anxiety, particularly anxiety as a trait (X2) in the whole study group. The change in anxiety as a state correlated with the disease duration, duration of dialysis and the initial level of anxiety as a state (t1X1). The change in anxiety as a trait significantly correlated with age and the initial level of anxiety (t1X2).



Undertaking physical training during dialysis by patients with ESRD is beneficial in reducing their levels of anxiety and depression. Both resistance and endurance training improves mood, but only endurance training additionally results in anxiety reduction.
Body Surface ECG Signal Shape Dispersion

The spatial distribution of the shape of the electrocardiography (ECG) waves obtained by body surface potential mapping (BSPM) is studied, using a 64-channel high-resolution ECG system. The index associated to each lead is the shape difference between its ECG wave and a reference computed taking into account all the leads on the same column. The reference is either a selected real wave or a synthetic signal computed by integral shape averaging (ISA). Better results are obtained with the ISA signal using the distribution function method (DFM) for computing the shape difference. The spatial dispersion of ECG waves is showed to allow the separation of patients after myocardial infarction (MI) from healthy subjects. In addition, the reference signal position for each column is computed. The path linking these positions appears as an invariant, i.e., it is independent of the subject and the ECG wave
Tumor flare reaction associated with lenalidomide treatment in patients with chronic lymphocytic leukemia predicts clinical response.

In patients with chronic lymphocytic leukemia (CLL), treatment with lenalidomide induces a unique, previously uncharacterized, immune response called tumor flare reaction (TFR). The clinical significance of this reaction remains unknown.



Forty-five patients with CLL who were treated with lenalidomide in a phase 2 clinical trial were evaluated for the clinical features, intensity, and duration of TFR. Correlation was made with tumor response and the immune cellular microenvironment. Steroids for the prophylaxis of TFR was not given to patients in Group A (n = 29) whereas patients in Group B (n = 16) received low-dose prednisone as well as a slow dose escalation of lenalidomide for the prevention of TFR.



Thirty (67%) patients experienced a TFR, with a grade 2 or 3 reaction (according to National Cancer Institute Common Toxicity Criteria [version 3.0]) observed in 33% of patients (47% in Group A and 9% in Group B; P = .05). The median time to onset of the TFR was 6 days, and was longer in the patients receiving prophylaxis (4 days vs 9 days, respectively; P = .01). A complete response was observed in 7 of 30 (23%) patients with TFR and 1 of 15 (7%) patients without TFR. The median progression-free survival was 19.9 months and 19.4 months, respectively, for patients with versus those without TFR (P = .92).



TFR is a unique immune-mediated phenomenon noted with lenalidomide treatment only in patients with CLL that correlates with clinical response. It can be effectively managed with anti-inflammatory agents.
Behavioural, educational and respiratory outcomes of antenatal betamethasone for term caesarean section (ASTECS trial)

To determine whether antenatal betamethasone prior to elective term caesarean section (CS) affects long term behavioural, cognitive or developmental outcome, and whether the risk of asthma or atopic disease is reduced.



A questionnaire based follow-up of a multicentre randomised controlled trial (Antenatal Steroids for Term Elective Caesarean Section, BMJ 2005).



Four UK study centres from the original trial.



862 participants from the four largest recruiting centres, 92% of the original study. 824 (96%) were traced and 799 (93%) were successfully contacted. Fifty-one percent (407/799) completed and returned the questionnaire. The children were aged 8-15 years (median 12.2 years, 52% girls). 386 gave consent to contact schools with 352 (91%) reports received.



Questionnaires including a strengths and difficulties questionnaire, International Study of Asthma and Allergies in Childhood, general health and school performance.



There were no significant differences between children whose mothers received betamethasone and controls for the mean total strengths and difficulties questionnaire scores and subscores for hyperactivity, emotional symptoms, prosocial behaviour, conduct or peer problems. 25 (12%) children whose mothers received betamethasone had reported learning difficulties compared with 27 (14%) control children. The proportion of children who achieved standard assessment tests KS2 exams level 4 or above for mathematics, English or science was similar as were the rates of ever reported wheeze (30% vs 30%), asthma (24% vs 21%), eczema (34% vs 37%) and hay fever (25% vs 27%).



Antenatal betamethasone did not result in any adverse outcomes or reduction in asthma or atopy. It should be considered for elective CS at 37-38 weeks of gestation.
Vitamin D Supplementation in Infants With Chronic Congestive Heart Failure

Increased circulating proinflammatory cytokines may contribute to the pathogenesis of congestive heart failure (CHF). In vitro studies have suggested that vitamin D suppresses proinflammatory cytokines and increases anti-inflammatory cytokines. The aim of this work was to evaluate the effect of vitamin D supplementation on renin-angiotensin system cytokines as well as different clinical, biochemical, and echocardiographic variables in infants with chronic CHF. This was a double-blind, placebo-controlled intervention study and included 80 infants with CHF. The intervention consisted of either giving Vitamin D3 oral drops (group I) or placebo oral drops (group II). In both study groups, baseline 25-hydroxyvitamin D [25(OH)D] concentrations were below the lower end of the reference range. After 12 weeks of intervention, vitamin D supplementation for group I infants caused significant improvement of HF score, left-ventricular (LV) end-diastolic diameter, LV end-systolic diameter, LV ejection fraction%, and myocardial performance index together with markedly increased serum 25(OH)D and interleukin (IL)-10 and decreased PTH, IL-6, and TNF-α compared with the placebo group; these differences were statistically significant (p < 0.001). Vitamin D supplementation has great benefits as an anti-inflammatory agent in infants with CHF. It helps acceleration of the clinical improvement and cytokine profile balance.
Influence of chromium-enriched yeast on blood glucose and insulin variables, blood lipids, and markers of oxidative stress in subjects with type 2 diabetes mellitus

The aim of this study was to determine the effect of chromium (Cr)-enriched yeast on blood glucose and insulin variables, blood lipids, and blood markers of oxidative stress in persons with type 2 diabetes mellitus (median duration: 3.0 yr). Thirty-six subjects (9 men, 27 women; mean age: 61.3 yr; mean body mass index: 34.33 kg/m2) were supplemented with 400 μg Cr/d as Cr-enriched yeast (n=19) or placebo (n=17) for 12 wk in a randomized, double-blind study. The most interesting results were obtained by comparison of the change in the placebo group to the change in the Cr group. The Cr group showed a significantly greater increase in serum Cr compared to the placebo group (p<0.05). Supplementation with Cr-enriched yeast was associated with a significant decrease in fasting serum glucose compared to placebo (p<0.01). Blood markers of oxidative stress glutathione peroxidase activity and levels of reduced glutathione were essentially unchanged in the Cr group after 12 wk, but decreased significantly in the placebo group (p<0.05, p<0.01, respectively), Serum HbA1c and glycated protein (fructosamine) were essentially unchanged in the Cr group, whereas HbA1c tended to increase in the placebo group (from 6.94% to 7.11%). Fasting serum insulin decreased in both groups, with a greater tendency in the Cr group (−16.5% vs −9.5%). These data suggest that supplementation of well-controlled type 2 diabetics with Cr-enriched yeast is safe and can result in improvements in blood glucose variables and oxidative stress.
What is the price of prevention? New evidence from a field experiment.

How does increasing access to treatment affect the demand for preventive testing? In this paper we present results from a field experiment in Nigeria in which we offered cervical cancer screening to women at randomly chosen prices. To test our hypothesis, we also offered women a lottery where the payoff was a subsidy towards the cost of cervical cancer treatment (conditional upon a diagnosis of cervical cancer). We find that women randomly selected to receive the conditional cancer treatment subsidy were about 4 percentage points more likely to take up screening than those in the control group. We also show that reducing the price of screening by 10 cents increased take-up by about 1 percentage point. These results offer compelling evidence that the optimal set of subsidies to increase take-up of preventive testing in developing countries, must include subsidies towards treatment costs (in addition to price subsidies).
Grief and trauma intervention for children after disaster: exploring coping skills versus trauma narration.

This study evaluated the differential effects of the Grief and Trauma Intervention (GTI) with coping skills and trauma narrative processing (CN) and coping skills only (C). Seventy African American children (6-12 years old) were randomly assigned to GTI-CN or GTI-C. Both treatments consisted of a manualized 11-session intervention and a parent meeting. Measures of trauma exposure, posttraumatic stress symptoms, depression, traumatic grief, global distress, social support, and parent reported behavioral problems were administered at pre, post, 3 and 12 months post intervention. In general, children in both treatment groups demonstrated significant improvements in distress related symptoms and social support, which, with the exception of externalizing symptoms for GTI-C, were maintained up to 12 months post intervention. Results suggest that building coping skills without the structured trauma narrative may be a viable intervention to achieve symptom relief in children experiencing trauma-related distress. However, it may be that highly distressed children experience more symptom relief with coping skills plus narrative processing than with coping skills alone. More research on the differential effects of coping skills and trauma narration on child distress and adaptive functioning outcomes is needed.
Does gender influence outcomes from a multidisciplinary intervention for quality of life designed for patients with advanced cancer?

Cancer treatment can profoundly impact the patient’s quality of life (QOL). It has been well documented that there are gender differences in the symptoms associated with cancer treatment. This study explores the impact of gender on QOL for patients with newly diagnosed advanced cancer. A randomized, controlled clinical trial in patients receiving radiotherapy for advanced cancer demonstrated maintenance of QOL with a six session multidisciplinary structured intervention compared to controls. This current study reports the gender differences in that trial. Outcome measures included the functional assessment of cancer therapy-general (FACT-G), linear analog self-assessment (LASA), and profile of mood states (POMS) at baseline and weeks 4, 27, and 52. Kruskal–Wallis was used to compare QOL scores. One hundred thirty-one patients (45 women and 86 men, mean age 58.7) participated in the clinical trial. At week 4 postintervention, women in the intervention group had statistically significant improvement in their FACT-G score, FACT-G physical well-being subscale, LASA fatigue, POMS total score, POMS fatigue–inertia subscale, and POMS confusion–bewilderment subscale (p < 0.05). Men receiving the intervention had a smaller decrease in FACT-G score compared to controls (p = 0.048) and also worsened on the LASA financial (p = 0.02). At week 27, the only gender difference was that intervention group men had more POMS anger–hostility (p = 0.009). By week 52, there were no statistically significant gender differences in any of the QOL measures. Gender-based differences appear to play a role in the early, but not late, response to a multidisciplinary intervention to improve QOL for patients with advanced cancer, suggesting that early interventions can be tailored for each gender.