nils-herrmann/clean_scirepeval huggingface dataset:
Maintenance of transplantation potential in ex vivo expanded CD34(+)-selected human peripheral blood progenitor cells.

CD34(+)-selected hematopoietic progenitor cells are being increasingly used for autotransplantation, and recent evidence indicates that these cells can be expanded ex vivo. Of 15 patients with solid tumors undergoing a phase I/II clinical trial using CD34(+)-selected peripheral blood progenitor cells (PBPCs) after high-dose chemotherapy, we analyzed the frequency of long-term culture-initiating cells (LTCIC) as a measure of transplantation potential before and after ex vivo expansion of CD34+ cells. PBPCs were mobilized by combination chemotherapy and granulocyte colony-stimulating factor (G-CSF). The original unseparated leukapheresis preparations, the CD34(+)-enriched transplants, as well as nonabsorbed fractions eluting from the CD34 immunoaffinity columns (Ceprate; CellPro, Bothell, WA) were monitored for their capacity to repopulate irradiated allogeneic stroma in human long-term bone marrow cultures. We found preservation of more than three quarters of fully functional LTCIC in the CD34(+)-selected fractions. Quantitation of LTCIC by limiting dilution analysis showed a 53-fold enrichment of LTCIC from 1/9,075 in the unseparated cells to an incidence of 1/169 in the CD34+ fractions. Thus, in a single apheresis, it was possible to harvest a median of 1.65 x 10(4) LTCIC per kg body weight (range, 0.71 to 3.72). In addition, in six patients, large-scale ex vivo expansions were performed using a five-factor cytokine combination consisting of stem cell factor (SCF), interleukin-1 (IL-1), IL-3, IL-6, and erythropoietin (EPO), previously shown to expand committed progenitor cells. LTCIC were preserved, but not expanded during the culture period. Optimization of ex vivo expansion growth factor requirements using limiting dilution assays for LTCIC estimation indicated that the five-factor combination using SCF, IL-1, IL-3, IL-6, and EPO together with autologous plasma was the most reliable combination securing both high progenitor yield and, at the same time, optimal preservation of LTCIC. Our data suggest that ex vivo-expanded CD34+ PBPCs might be able to allow long-term reconstitution of hematopoiesis.
Effectiveness of varenicline and counselling for smoking cessation in an observational cohort study in China

To evaluate the effectiveness of varenicline for smoking cessation in Chinese smokers in a real world cessation clinic practice.



A prospective observational study.



Beijing, China.



A total of 924 smokers (883 men and 41 women) who attended a smoking cessation clinic of a large general hospital were assessed with data from structured questionnaires at baseline and follow-up at 1, 3 and 6 months. Trained physician counsellors provided free individual counselling for all subjects and follow-up interviews with brief counselling. 332 subjects additionally prescribed varenicline according to their own choice were compared with those without varenicline.



Primary outcomes were self-reported 7-day point prevalence abstinence rate and 3-month continuous abstinence rate at 6-month follow-up. Secondary outcomes were 7-day point prevalence abstinence rates at 1 and 3-month follow-up, and 1-month continuous abstinence rate at 3-month follow-up.



By intention-to-treat, the 7-day point prevalence abstinence rate with varenicline and counselling at 6 months was significantly higher than counselling only (37.0% vs 23.1%; OR, 1.75; 95% CI 1.46 to 2.62; p=0.001). The 3-month continuous abstinence rate at 6 months was higher with varenicline (33.1% vs 18.4%; OR, 2.04; 95% CI 1.61 to 2.99; p<0.001). Varenicline also showed better secondary outcomes.



Varenicline prescription in the smoking cessation clinic appeared to be effective with doubling of quit rates in Chinese smokers in a real world cessation clinic practice.
Decisional capacity for research participation in individuals with mild cognitive impairment.

To assess decisional capacity performance and the neuropsychological correlates of such performance to better understand higher-level instrumental activities of daily living in individuals with mild cognitive impairment (MCI).



Cross-sectional.



Research center, medical center, or patient's home.



Forty participants with MCI and 40 cognitively normal older controls (NCs) aged 60 to 90 (mean age+/-standard deviation 73.3+/-6.6; 54% female).



Capacity to provide informed consent for a hypothetical, but ecologically valid, clinical trial was assessed using the MacArthur Competence Assessment Tool for Clinical Research. Neuropsychological functioning was assessed using a comprehensive protocol.



Adjusted between-group comparisons yielded significant differences for most decisional capacity indices examined, including Understanding (P=.001; NC>MCI) and Reasoning (P=.002; NC>MCI). Post hoc analyses revealed that participants with MCI who were categorized as capable of providing informed consent according to expert raters had higher levels of education than those who were categorized as incapable.



The findings suggest that many individuals with MCI perform differently on a measure of decisional capacity than their NC peers and that participants with MCI who are incapable of providing informed consent on a hypothetical and complex clinical trial are less educated. These findings are consistent with prior studies documenting functional and financial skill difficulties in individuals with MCI.
GET.ON Mood Enhancer: efficacy of Internet-based guided self-help compared to psychoeducation for depression: an investigator-blinded randomised controlled trial

Major depressive disorder (MDD) imposes a considerable disease burden on individuals and societies. A large number of randomised controlled trials (RCTs) have shown the efficacy of Internet-based guided self-help interventions in reducing symptoms of depression. However, study quality varies considerably. The aim of this study is to evaluate the efficacy of a new Internet-based guided self-help intervention (GET.ON Mood Enhancer) compared to online-based psychoeducation in an investigator-blinded RCT.



A RCT will be conducted to compare the efficacy of GET.ON Mood Enhancer with an active control condition receiving online psychoeducation on depression (OPD). Both treatment groups will have full access to treatment as usual. Adults with MDD (n=128) will be recruited and randomised to one of the two conditions. Primary outcome will be observer-rated depressive symptoms (HRSD-24) by independent assessors blind to treatment conditions. Secondary outcomes include changes in self-reported depressive symptom severity, anxiety and quality of life. Additionally, potential negative effects of the treatments will systematically be evaluated on several dimensions (for example, symptom deteriorations, attitudes toward seeking psychological help, relationships and stigmatisation). Assessments will take place at baseline, 6 and 12 weeks after randomisation.



This study evaluates a new Internet-based guided self-help intervention for depression using an active control condition (psychoeducation-control) and an independent, blinded outcome evaluation. This study will further enhance the evidence for Internet-based guided self-help interventions for MDD.
Effect of low-dose valsartan on proteinuria in normotensive immunoglobulin A nephropathy with minimal proteinuria: a randomized trial

Immunoglobulin A nephropathy (IgAN) is a generally progressive disease, even in patients with favorable prognostic features. In this study, we aimed to investigate the antiproteinuric effect and tolerability of low-dose valsartan (an angiotensin II receptor blocker) therapy in normotensive IgAN patients with minimal proteinuria of less than 0.5 to 1.0 g/day.



Normotensive IgAN patients, who had persistent proteinuria with a spot urine protein-to-creatinine ratio of 0.3 to 1.0 mg/mg creatinine, were recruited from five hospitals and randomly assigned to either 40 mg of valsartan as the low-dose group or 80 mg of valsartan as the regular-dose group. Clinical and laboratory data were collected at baseline, and at 4, 8, 12, and 24 weeks after valsartan therapy.



Forty-three patients (low-dose group, n = 23; regular-dose group, n = 20) were enrolled in the study. Proteinuria decreased significantly not only in the regular-dose group but also in the low-dose group. The change in urine protein-to-creatinine ratio at week 24 was -41.3% ± 26.1% (p < 0.001) in the regular-dose group and -21.1% ± 45.1% (p = 0.005) in the low-dose group. In the low-dose group, blood pressure was constant throughout the study period, and there was no symptomatic hypotension. In the regular-dose group, blood pressure decreased at weeks 8 and 12. No significant change in glomerular filtration rate, serum creatinine level, or serum potassium level was observed during the study period.



Our results suggest that low-dose valsartan can significantly reduce proteinuria without causing any intolerability in normotensive IgAN patients with minimal proteinuria.
Randomized controlled trial of atomoxetine for cognitive dysfunction in early Huntington disease.

Cognitive symptoms are associated with functional disability in Huntington disease; yet, few controlled trials have examined cognitive treatments that could improve patient independence and quality of life. Atomoxetine is a norepinephrine reuptake inhibitor approved for treatment of attention-deficit/hyperactivity disorder.



Twenty participants with mild Huntington disease who complained of inattention were randomized to receive atomoxetine (80 mg/d) or placebo in a 10-week double-blind crossover study. Primary outcome measures were self-reported attention and attention and executive neuropsychological composite scores. Secondary outcomes were psychiatric and motor symptom scores.



The rate of reported adverse effects while on atomoxetine was 56% (vs 35% on placebo), which most commonly included dry mouth (39%), loss of appetite (22%), insomnia (22%), and dizziness (17%). There were no serious adverse events related to atomoxetine. There were statistically significant, although mild, increases in heart rate and diastolic blood pressure on atomoxetine, consistent with other studies and not requiring medical referral. There were no significant improvements while on atomoxetine compared with placebo on primary outcomes. However, there was evidence of significant placebo effects on self-reported attention and psychiatric functions. There were no group differences on the Unified Huntington's Disease Rating total motor score.



Atomoxetine demonstrated no advantages over placebo for primary or secondary outcomes. Although atomoxetine was not effective at improving attention at this dose, its safety and tolerability were similar to other studies.
Effect of acute kidney injury on mortality and hospital stay in patient with severe acute pancreatitis.

Severe acute pancreatitis (SAP) is believed to be a major risk factor leading to acute kidney injury (AKI) among critically ill patients, but little is known about SAP-induced AKI. We study the incidence of AKI defined by the Acute Kidney Injury Network (AKIN) criteria and the risk factors associated with outcomes among SAP-induced AKI patients.



We conducted a multicenter retrospective study of critically ill SAP-induced AKI patients during the period August 2009 to June 2013. Data on enrolled patients were retrieved from electronic records. Univariate and multiple regression analyses were performed.



Among a total of 414 SAP patients admitted to intensive care units(ICU), 287 (69.3%) developed AKI during their ICU stay, with 16.7%, 18.4%, and 34.3% classified as AKI stage I,II, and III, respectively. SAP-induced AKI patients experienced a significantly higher ICU mortality than those without AKI. The risk factors associated with ICU mortality among SAP-induced AKI patients included ACS (odds ratio (OR) 10.58), RRT (OR 3.31), sepsis (OR 2.46), CTSI (OR 3.01), APACHE II score (OR 1.82), AKI III (OR 1.38), ICU-length-of-stay (OR 1.04), and multi-organ failure.



The paper represents the first attempt to investigate the etiology and epidemiology of AKI following SAP under the AKIN criteria among critically ill patients. Several independent risk factors were found to be associated with ICU mortality for AKI patients. The findings may pinpoint crucial therapeutic measures for preventing AKI among a vulnerable population and for more effective management of SAP-induced AKI to improve the quality of intensive care.
Feasibility of using volunteer research staff to deliver and evaluate a low-fat dietary intervention: the American Cancer Society Breast Cancer Dietary Intervention Project.

This report presents the results of a study to examine the feasibility of using volunteers as research staff for a randomized trial of whether reduction in dietary fat intake could prevent or delay breast cancer recurrence. We examined whether volunteers could be trained to recruit study participants, deliver a complex and intensive dietary intervention, and monitor intervention effectiveness. Volunteers, who were mostly employed nurses and dietitians, screened 521 women, of whom 293 were eligible and 144 were randomized. Participants were postmenopausal women under age 75, who had recently been diagnosed with breast cancer and treated with either mastectomy or lumpectomy. At 1 year postrandomization, 77% of intervention and 75% of control participants remained active in the study. Intervention effects (change in intervention group minus change in control group) at 3, 6, and 12 months postrandomization were 5.9, 8.4, and 7.2% energy from fat and 1.7, 3.0, and 3.5 kg body weight (all P < 0.001). These results were similar to those from other studies that used paid, professional staff to deliver and monitor interventions. Results from this feasibility study suggest that volunteer-based health organizations can provide research opportunities for health practitioners and can conduct high-quality research at lower costs.
Cortical Reorganization Due to Impaired Cerebral Autoregulation in Individuals With Occlusive Processes of the Internal Carotid Artery

To study the impact of impaired cerebral autoregulation on cortical neurophysiology, long term potentiation (LTP)-like plasticity, motor learning and brain structure.



12 patients with unilateral occlusion or severe stenosis of the internal carotid artery were included. Impairment of cerebral autoregulation was determined by vasomotor reactivity in transcranial Doppler sonography. Corticomotor excitability, cortical silent period and LTP-like plasticity were assessed with transcranial magnetic stimulation, motor learning with a force production task, and brain structure with high-resolution MRI of the brain.



In the affected hemisphere, corticomotor excitability was significantly higher, cortical silent period and LTP-like plasticity significantly lower, compared to the contralateral side. No significant difference emerged for motor learning, cortical thickness and white matter integrity between the hemispheres.



Despite decreased LTP-like plasticity in the affected hemisphere, motor learning was comparable between hemispheres, possibly due to gamma-aminobutyric-acid (GABA)B-mediated corticomotor excitability changes within the affected hemisphere. Our results may help to develop interventions to beneficially modulate cortical physiology in the presence of cerebral hypoperfusion.
A phase I clinical trial of navitoclax, a targeted high-affinity Bcl-2 family inhibitor, in combination with gemcitabine in patients with solid tumors

To investigate the safety, optimal dosing, pharmacokinetics and clinical activity of a regimen of navitoclax (ABT-263) combined with gemcitabine in patients with solid tumors.  Patients with solid tumors for which gemcitabine was deemed an appropriate therapy were enrolled into one of two different dosing schedules (21-day dosing schedule: navitoclax administered orally on days 1–3 and 8–10,; and gemcitabine 1,000 mg/m2 on days 1 and 8; 28-day dosing schedule: navitoclax administrated orally on days 1–3, 8–10, and 15–17; and gemcitabine 1,000 mg/m2 on days 1, 8 and 15). Navitoclax doses were escalated from 150 to 425 mg. An expanded safety cohort was conducted for the 21-day dosing schedule at the maximum tolerated dose (MTD) of navitoclax.  Forty-six patients were enrolled at three U.S. centers. The most common adverse events included: hematologic abnormalities (thrombocytopenia, neutropenia, and anemia), liver enzyme elevations (ALT and AST), and gastrointestinal disturbances (diarrhea, nausea, and vomiting). Dose-limiting toxicities (DLTs) observed in cycle 1 were grade 4 thrombocytopenia (2 patients), grade 4 neutropenia (1 patient), and grade 3 AST elevation (2 patients). The MTD of navitoclax was 325 mg co-administered with gemcitabine 1,000 mg/m2 for the 21-day schedule. No clinically significant pharmacokinetic drug–drug interactions were observed. There were no objective responses. Stable disease, reported at the end of cycle 2, was the best response in 54 % of evaluable patients (n = 39).  The combination of navitoclax 325 mg with gemcitabine 1,000 mg/m2 was generally well tolerated and exhibited a favorable safety profile in patients with advanced solid tumors.
Compressive Sensing of Internet Traffic Matrices using CUR Decomposition

Missing values in traffic matrix (TM) is a well known fact which needs to be interpolated with least error as TM is a key input to various network operations and management tasks. Compressive sensing deals with the reconstruction of missing observations by taking advantage of the presence of low-rank structure in TMs. Matrix decomposition techniques, more specifically singular value decomposition (SVD) and its variants such as sparsity regularized matrix factorization (SRMF) and sparsity regularized SVD (SRSVD), has attracted considerable attention in the field of compressive sensing of traffic matrices. However, SVD suffers from two limitations stemmed in its assumptions, which involves an assumption of continuous random variables and lack of interpretability of decomposed matrices.
 In the present work, in order to address the above-identified limitations we develop a simple yet powerful compressive sensing framework with two key components: i) Temporally Local Interpolation (TLI) and ii) CUR decomposition. We utilize a publicly available real traffic matrix obtained from Abilene network. Results show that i) our preprocessing technique, TLI, outperforms existing baseline approximation in terms of exhibiting least error in reconstruction of missing values with loss rates ranging from 1% to 98%. ii) The proposed framework can reconstruct up to 98% of the pure random missing data with an error of 29.8%, which is found to be comparatively better than SVD-based approaches. iii) When augmented with k-Nearest Neighbors (KNN), the proposed framework can reconstruct up to 98% of the pure random missing data with an error of 28.9%, which is comparatively better than (SRMF + KNN) and (SRSVDB + KNN). iv) The proposed framework is also found to be computationally efficient in terms of low computational time as it takes less than 0.7 seconds (using Matlab on a 3.20 GHz Windows machine), which is the least computational time taken as compared to SRMF (3.02 seconds), NMF (1.01 seconds), SRSVD (1.00 second) and SRSVD base (0.83 seconds).
Effect of frusemide on cough responses to chloride-deficient solution in normal and mild asthmatic subjects.

We studied the tussive effects of a chloride-deficient solution (1.26% sodium bicarbonate). Nine normal volunteers and 10 mild asthmatic subjects were studied. In two double-blind, placebo-controlled, cross-over studies, we assessed the profile of any inhibitory effects that inhaled frusemide had over these responses. Baseline cough challenge was followed by inhalation of either frusemide (40 mg), or 0.15 M NaCl control. Cough was then induced at 0.5, 2, 4 and 6 h after treatment. Forced expiratory volume in one second (FEV1) was measured before and after each challenge. Changes from the baseline cough response due to drug or control were compared nonparametrically at each time point. There was no difference in the sensitivity of normal and asthmatic subjects to the cough challenge (median cough response 15 and 14.5 on control day, 12 and 15 on frusemide day). Frusemide caused sustained inhibition of the cough response in normal subjects (p < 0.05 at 2 h, p < 0.01 at 4 h), but had only a small, nonsignificant effect in asthmatic subjects at 30 min. Falls in FEV1 of asthmatic subjects due to the chloride-deficient solution were not significant, and did not correlate with number of coughs. We conclude that mild asthmatic subjects are less sensitive than normal subjects to the influence of frusemide against low chloride challenge. This observation is not explained by bronchoconstrictor effects of the cough challenge in asthmatic subjects.
Erlotinib is effective in pancreatic cancer with epidermal growth factor receptor mutations: a randomized, open-label, prospective trial

To analyze the efficacy of gemcitabine with or without erlotinib for pancreatic cancer, and to determine the predictive role of epidermal growth factor receptor (EGFR) and KRAS mutations in these patients.



This was a single-center, randomized, open-label, prospective trial. Eighty-eight chemotherapy-naïve metastatic pancreatic cancer patients were randomized for treatment with gemcitabine or gemcitabine plus erlotinib. EGFR and KRAS mutations were analyzed, respectively. The primary endpoint was the disease control rate.



Disease control rate (64% vs. 25%; P < 0.001), progression-free survival (median 3.8 vs. 2.4 months; P < 0.001), and overall survival (median 7.2 vs. 4.4 months; P < 0.001) were better in the gemcitabine plus erlotinib group than in the gemcitabine alone group. In the gemcitabine plus erlotinib group, disease control (85% vs. 33%; P = 0.001), progression-free survival (median 5.9 vs. 2.4 months; P = 0.004), and overall survival (median 8.7 vs. 6.0 months; P = 0.044) were better in patients with EGFR mutations than in those without EGFR mutations. KRAS mutation was not associated with treatment response or survival.



Gemcitabine plus erlotinib is more effective than gemcitabine alone for treating metastatic pancreatic cancer patients, especially those with EGFR mutations.