LLukas22/scidocs huggingface dataset:
Phase 2 Placebo-Controlled Trial of Two Vaccines to Prevent Ebola in Liberia.

BACKGROUND
The safety and efficacy of vaccines to prevent Ebola virus disease (EVD) were unknown when the incidence of EVD was peaking in Liberia.


METHODS
We initiated a randomized, placebo-controlled, phase 3 trial of the chimpanzee adenovirus 3 vaccine (ChAd3-EBO-Z) and the recombinant vesicular stomatitis virus vaccine (rVSV∆G-ZEBOV-GP) in Liberia. A phase 2 subtrial was embedded to evaluate safety and immunogenicity. Because the incidence of EVD declined in Liberia, the phase 2 component was expanded and the phase 3 component was eliminated.


RESULTS
A total of 1500 adults underwent randomization and were followed for 12 months. The median age of the participants was 30 years; 36.6% of the participants were women. During the week after the administration of vaccine or placebo, adverse events occurred significantly more often with the active vaccines than with placebo; these events included injection-site reactions (in 28.5% of the patients in the ChAd3-EBO-Z group and 30.9% of those in the rVSV∆G-ZEBOV-GP group, as compared with 6.8% of those in the placebo group), headache (in 25.1% and 31.9%, vs. 16.9%), muscle pain (in 22.3% and 26.9%, vs. 13.3%), feverishness (in 23.9% and 30.5%, vs. 9.0%), and fatigue (in 14.0% and 15.4%, vs. 8.8%) (P<0.001 for all comparisons); these differences were not seen at 1 month. Serious adverse events within 12 months after injection were seen in 40 participants (8.0%) in the ChAd3-EBO-Z group, in 47 (9.4%) in the rVSV∆G-ZEBOV-GP group, and in 59 (11.8%) in the placebo group. By 1 month, an antibody response developed in 70.8% of the participants in the ChAd3-EBO-Z group and in 83.7% of those in the rVSV∆G-ZEBOV-GP group, as compared with 2.8% of those in the placebo group (P<0.001 for both comparisons). At 12 months, antibody responses in participants in the ChAd3-EBO-Z group (63.5%) and in those in the rVSV∆G-ZEBOV-GP group (79.5%) remained significantly greater than in those in the placebo group (6.8%, P<0.001 for both comparisons).


CONCLUSIONS
A randomized, placebo-controlled phase 2 trial of two vaccines that was rapidly initiated and completed in Liberia showed the capability of conducting rigorous research during an outbreak. By 1 month after vaccination, the vaccines had elicited immune responses that were largely maintained through 12 months. (Funded by the National Institutes of Allergy and Infectious Diseases and the Liberian Ministry of Health; PREVAIL I ClinicalTrials.gov number, NCT02344407 .).
An investigation of factors that impact behavioral outcomes of software engineers

The purpose of this study is to examine the effects of a set of environmental factors on desired behavioral outcomes of software engineers. The results show that team rotation has a positive direct effect on an individual’s job satisfaction and, therefore, art indirect effect on organizational commitment. The use of structured analysis techniques results in increasing the individual’s perception of role conflict which indirectly decreases organizational commitment. The use of CASE tools, however, helps to reduce role conflict. CASE tool usage also has a dh-ect positive effect on the software engineer’s organizational commitment. The type of work an individual performed had a direct effect on the individual’s perception of how innovative their project tasks were. Software development work resulted in more innovative projects while software enhancement work resulted in less innovative projects. A somewhat surprising result is that the percentage of time spent on development projects tends to result in lower job satisfaction. The mediating variable, innovative projects, reduces role ambiguity and role conflict. More innovative projects also directly increase job satisfaction. Due to these direct affects, increased project innovation has a large indirect effect on organizational commitment. The results show that a relatively small number of environmental factors can explain a significant portion of a software engineers’ perceptions of job satisfaction and organizational commitment. BACKGROUND AND INTRODUCTION Early studies concerned with software engineering performance and productivity found that individual characteristics of software engineers were significantly
A multicentre randomised controlled trial to compare the pharmacokinetics, efficacy and safety of CT-P10 and innovator rituximab in patients with rheumatoid arthritis

OBJECTIVE
To demonstrate pharmacokinetic equivalence of CT-P10 and innovator rituximab (RTX) in patients with rheumatoid arthritis (RA) with inadequate responses or intolerances to antitumour necrosis factor agents.


METHODS
In this randomised phase I trial, patients with active RA were randomly assigned (2:1) to receive 1000 mg CT-P10 or RTX at weeks 0 and 2 (alongside continued methotrexate therapy). Primary endpoints were area under the serum concentration-time curve from time zero to last quantifiable concentration (AUC0-last) and maximum serum concentration after second infusion (Cmax). Additional pharmacokinetic parameters, efficacy, pharmacodynamics, immunogenicity and safety were also assessed. Data are reported up to week 24.


RESULTS
103 patients were assigned to CT-P10 and 51 to RTX. The 90% CIs for the ratio of geometric means (CT-P10/RTX) for both primary endpoints were within the bioequivalence range of 80%-125% (AUC0-last: 97.7% (90% CI 89.2% to 107.0%); Cmax: 97.6% (90% CI 92.0% to 103.5%)). Pharmacodynamics and efficacy were comparable between groups. Antidrug antibodies were detected in 17.6% of patients in each group at week 24. CT-P10 and RTX displayed similar safety profiles.


CONCLUSIONS
CT-P10 and RTX demonstrated equivalent pharmacokinetics and comparable efficacy, pharmacodynamics, immunogenicity and safety.


TRIAL REGISTRATION NUMBER
NCT01534884.
COMMENTARY ON THE SCIENCE‐RELIGION CONTROVERSY

. The science-religion exchange in failing to address fundamental issues is popular but ineffective. Reductionism and determinism, teleology, the assumed centrality of ethics in religion and progress must be reexamined to unify the task of science and religion into a common search for meaning in its eschatological dimension
Dropout Prediction in MOOCs using Learner Activity Features

While MOOCs offer educational data at a new scale, many educators have been alarmed by their high dropout rates. Learners join a course with some motivation to persist for some or all of the course, but various factors, such as attrition or lack of satisfaction, can lead them to disengage or totally drop out. Educational interventions targeting such risk factors can help reduce dropout rates. However, intervention design requires the ability to predict dropout accurately and early enough to allow for timely intervention delivery. In this paper, we present a dropout predictor that uses student activity features to predict which students are at risk high of dropout. The predictor succeeds in red-flagging 40% 50% of dropouts while they are still active. An additional 40% 45% are red-flagged within 14 days of absence from the course.
Forensic evidence findings in prepubertal victims of sexual assault.

OBJECTIVE
The American Academy of Pediatrics recommends forensic evidence collection when sexual abuse has occurred within 72 hours, or when there is bleeding or acute injury. It is not known whether these recommendations are appropriate for prepubertal children, because few data exist regarding the utility of forensic evidence collection in cases of child sexual assault. This study describes the epidemiology of forensic evidence findings in prepubertal victims of sexual assault.


METHODS
The medical records of 273 children <10 years old who were evaluated in hospital emergency departments in Philadelphia, Pennsylvania, and had forensic evidence processed by the Philadelphia Police Criminalistics Laboratory were retrospectively reviewed for history, physical examination findings, forensic evidence collection, and forensic results.


RESULTS
Some form of forensic evidence was identified in 24.9% of children, all of whom were examined within 44 hours of their assault. Over 90% of children with positive forensic evidence findings were seen within 24 hours of their assault. The majority of forensic evidence (64%) was found on clothing and linens, yet only 35% of children had clothing collected for analysis. After 24 hours, all evidence, with the exception of 1 pubic hair, was recovered from clothing or linens. No swabs taken from the child's body were positive for blood after 13 hours or sperm/semen after 9 hours. A minority of children (23%) had genital injuries. Genital injury and a history of ejaculation provided by the child were associated with an increased likelihood of identifying forensic evidence, but several children had forensic evidence found that was unanticipated by the child's history.


CONCLUSIONS
The general guidelines for forensic evidence collection in cases of acute sexual assault are not well-suited for prepubertal victims. The decision to collect evidence is best made by the timing of the examination. Swabbing the child's body for evidence is unnecessary after 24 hours. Clothing and linens yield the majority of evidence and should be pursued vigorously for analysis.
The enactment of socio-technical transition pathways : A reformulated typology and a comparative multi-level analysis of the German and UK low-carbon electricity transitions ( 1990 – 2014 )

This paper aims to make two contributions to the sustainability transitions literature, in particular the Geels and Schot (2007. Res. Policy 36(3), 399) transition pathways typology. First, it reformulates and differentiates the typology through the lens of endogenous enactment, identifying the main patterns for actors, formal institutions, and technologies. Second, it suggests that transitions may shift between pathways, depending on struggles over technology deployment and institutions. Both contributions are demonstrated with a comparative analysis of unfolding low-carbon electricity transitions in Germany and the UK between 1990–2014. The analysis shows that Germany is on a substitution pathway, enacted by new entrants deploying small-scale renewable electricity technologies (RETs), while the UK is on a transformation pathway, enacted by incumbent actors deploying large-scale RETs. Further analysis shows that the German transition has recently shifted from a ‘stretch-and-transform’ substitution pathway to a ‘fit-and-conform’ pathway, because of a fightback from utilities and altered institutions. It also shows that the UK transition moved from moderate to substantial incumbent reorientation, as government policies became stronger. Recent policy changes, however, substantially downscaled UK renewables support, which is likely to shift the transition back to weaker reorientation. © 2016 The Authors. Published by Elsevier B.V. This is an open access article under the CC BY license (http://creativecommons.org/licenses/by/4.0/).
Effect of high temperature on the reproductive development of chickpea genotypes under controlled environments

High temperature during the reproductive stage in chickpea (Cicer arietinum L.) is a major cause of yield loss. The objective of this research was to determine if that variation can be explained by differences in anther and pollen development under heat stress. Therefore the effect of high temperature during the preand postanthesis periods on pollen viability, pollen germination in a medium, pollen germination on the stigma, pollen tube growth and pod set in a heat tolerant (ICCV
Performance measures of game controllers in a three-dimensional environment

Little work exists on the testing and evaluation of computer-game related input devices. This paper presents five new performance metrics and utilizes two tasks from the literature to quantify differences between input devices in constrained threedimensional environments, similar to “first-person”-genre games. The metrics are Mean Speed Variance, Mean Acceleration Variance, Percent View Moving, Target Leading Analysis, and Mean Time-to-Reacquire. All measures are continuous, as they evaluate movement during a trial. The tasks involved tracking a moving target for several seconds, with and without target acceleration. An evaluation between an X-Box gamepad and a standard PC mouse demonstrated the ability of the metrics to help reveal and explain performance differences between the devices. CR Categories: H.1.2 [User/Machine Systems]: Human Factors; H.5.2 [User Interfaces]: Evaluation Methodology.
Investigating enterprise systems adoption: uncertainty avoidance, intrinsic motivation, and the technology acceptance model

Received: 24 November 2004 Revised: 6 March 2005 2nd Revision: 22 April 2005 Accepted: 5 May 2005 Abstract Enterprise systems are gaining interest from both practitioners and researchers because of their potential linkages to organizational and individual user’s productivity. Information systems (IS) researchers have been investigating the implementation and adoption issues of enterprise systems based on the organizational IS management perspectives. However, there are few papers that investigate enterprise systems management and implementation issues based on the informal control mechanisms, although the enterprise systems are control tools in the organization. Specifically, this paper applies Enterprise Resource Planning (ERP) adoption and implementation to the informal controls, such as cultural control and self-control, which can be viewed as a tacit perspective in knowledge management. Uncertainty avoidance and perceived enjoyment are used as informal controls in the ERP implementation in this paper, and are linked to the technology acceptance variables to investigate the relationships among them. Sociotechnical design, organizational control mechanism, knowledge management, and individual motivation are reviewed to support this potential linkage in the model. Field data via the online survey of ERP systems user group (n1⁄4 101) are analyzed with partial least squares and supported our hypotheses. Uncertainty avoidance cultural control and intrinsic motivation as self-control are the important antecedents of ERP systems adoption. Furthermore, the result helps the systems manager understand that informal controls should be applied to the ERP systems implementation to enhance tacit and social aspects of IS management. European Journal of Information Systems (2005) 14, 150–161. doi:10.1057/palgrave.ejis.3000532
Assessment of Sources of Heavy Metals and SOx Emissions in the Southern Ural Mountains and Recommendations for Emissions Abatement

To identify key environmental policy issues in the Ural mountains, particularly concerned with air pollution. Discussions between Western and Russian experts aim to formulate a strategy to address the serious environmental issues of the Region.
Role of reflexology and antiepileptic drugs in managing intractable epilepsy--a randomized controlled trial.

BACKGROUND
This report is based on the results of a randomized parallel controlled trial conducted to determine the efficacy of reflexology therapy in managing intractable epilepsy.


METHODS
Subjects who failed epilepsy surgery or were not candidates for epilepsy surgery or were non-responders of antiepileptic drugs (AEDs) took part in this study. The trial was completed by 77 subjects randomly assigned to 2 arms: control (AEDs) and reflexology (AEDs + reflexology therapy). The hypothesis was that hand reflexology therapy could produce results similar to those of vagus nerve stimulation, and foot reflexology therapy could maintain homeostasis in the functional status of individual body parts. Reflexology therapy was applied by family members. The follow-up period was 1.5 years. Quality of life in epilepsy patients was assessed with the QOLIE-31 instrument.


RESULTS
In the reflexology group, the median baseline seizure frequency decreased from 9.5 (range 2-120) to 2 (range 0-110) with statistical significance (p < 0.001). In the control arm, the decrease was less than 25% with a baseline value of 16 (range 2-150). The pretherapy QOLIE-31 scores in the control group and the reflexology group were 41.05 ± 7 and 43.6 ± 8, respectively. Posttherapy data were 49.07 ± 6 and 65.4 ± 9, respectively (p < 0.002). The reflexology method allowed detection of knee pain in 85% of the reflexology group patients (p < 0.001), and 85.3% of patients derived 81% relief from it (p < 0.001). 4 reflexology group patients reported nausea/vomiting (n = 1), change in voice (n = 2), and hoarseness (n = 1).


CONCLUSION
Reflexology therapy together with AEDs may help reducing seizure frequency and improving quality of life in individuals with epilepsy.
Queuing theory accurately models the need for critical care resources.

BACKGROUND
Allocation of scarce resources presents an increasing challenge to hospital administrators and health policy makers. Intensive care units can present bottlenecks within busy hospitals, but their expansion is costly and difficult to gauge. Although mathematical tools have been suggested for determining the proper number of intensive care beds necessary to serve a given demand, the performance of such models has not been prospectively evaluated over significant periods.


METHODS
The authors prospectively collected 2 years' admission, discharge, and turn-away data in a busy, urban intensive care unit. Using queuing theory, they then constructed a mathematical model of patient flow, compared predictions from the model to observed performance of the unit, and explored the sensitivity of the model to changes in unit size.


RESULTS
The queuing model proved to be very accurate, with predicted admission turn-away rates correlating highly with those actually observed (correlation coefficient = 0.89). The model was useful in predicting both monthly responsiveness to changing demand (mean monthly difference between observed and predicted values, 0.4+/-2.3%; range, 0-13%) and the overall 2-yr turn-away rate for the unit (21%vs. 22%). Both in practice and in simulation, turn-away rates increased exponentially when utilization exceeded 80-85%. Sensitivity analysis using the model revealed rapid and severe degradation of system performance with even the small changes in bed availability that might result from sudden staffing shortages or admission of patients with very long stays.


CONCLUSIONS
The stochastic nature of patient flow may falsely lead health planners to underestimate resource needs in busy intensive care units. Although the nature of arrivals for intensive care deserves further study, when demand is random, queuing theory provides an accurate means of determining the appropriate supply of beds.
Safety of gadoversetamide in patients with acute and chronic myocardial infarction.

PURPOSE
To assess the safety data from two large, multicenter, phase 2 trials on the use of gadoversetamide (OptiMARK, Tyco Healthcare/Mallinckrodt, St. Louis, MO) as a contrast agent in delayed hyperenhancement magnetic resonance imaging (DE-MRI) in patients with acute and chronic myocardial infarction (MI).


MATERIALS AND METHODS
The study population from both trials comprised 577 patients who were randomly assigned to one of four dose groups (0.05, 0.1, 0.2, or 0.3 mmol/kg) before undergoing DE-MRI. Safety evaluations included physical and electrocardiographic (ECG) examinations. Vital signs, laboratory values, adverse events (AE), and serious adverse events (SAE) were monitored before and after contrast administration.


RESULTS
Of the 577 patients who received gadoversetamide, 124 (21.5%) reported a total of 164 AEs; most were mild (139 AEs; 84.8%) or moderate (25 AEs; 15.2%). ECG-related changes were the most frequent AE. Site investigators judged only eight AEs as likely related to gadoversetamide and only two of the eight as clinically relevant. Further evaluation suggested neither AE was related to gadoversetamide. Two SAEs were reported, but none was judged related to gadoversetamide by the site investigators.


CONCLUSION
Gadoversetamide is safe for use in patients with acute or chronic MI up to a dose of 0.3 mmol/kg.
Managing symptoms in patients with advanced lung cancer during radiotherapy: results of a psychoeducational randomized controlled trial.

CONTEXT
Breathlessness, fatigue, and anxiety are distressing symptoms for patients with advanced lung cancer. Usually managed as isolated symptoms, they often can occur simultaneously. Previous research often has addressed management of discrete symptoms rather than considering them as a cluster, which, in reality, is the situation faced by patients.


OBJECTIVES
This study aimed to examine the effectiveness of a psychoeducational intervention (PEI) on the symptom cluster of anxiety, breathlessness, and fatigue, compared with usual care.


METHODS
A pretest/post-test, two-group, randomized, controlled trial was conducted. Education on symptom management and coaching in the use of progressive muscle relaxation were delivered to patients one week prior to commencing radiotherapy (RT), and repeated three weeks after beginning RT. Symptom data were collected at four time points: prior to the intervention, three weeks, six weeks, and 12 weeks postintervention.


RESULTS
One hundred forty lung cancer patients receiving palliative RT were recruited from a publicly funded hospital in Hong Kong. Doubly multivariate analysis of variance revealed a significant difference (time×group interaction effect, P=0.003) over time between the PEI and usual care control group on the pattern of change of the symptom cluster. Significant effects on the patterns of changes in breathlessness (P=0.002), fatigue (P=0.011), anxiety (P=0.001), and functional ability (P=0.000) also were found.


CONCLUSION
PEI is a promising treatment for relieving the symptom cluster and each of the individually assessed symptoms. More effort needs to be directed at studying impact of interventions on common symptom clusters.
Continuous subcutaneous insulin infusion and multiple daily injection therapy are equally effective in type 2 diabetes: a randomized, parallel-group, 24-week study.

OBJECTIVE
Compare the efficacy, safety, and patient satisfaction of continuous subcutaneous insulin infusion (CSII) therapy with multiple daily injection (MDI) therapy for patients with type 2 diabetes.


RESEARCH DESIGN AND METHODS
A total of 132 CSII-naive type 2 diabetic patients were randomly assigned (1:1) to CSII (using insulin aspart) or MDI therapy (bolus insulin aspart and basal NPH insulin) in a multicenter, open-label, randomized, parallel-group, 24-week study. Efficacy was assessed with HbA(1c) and eight-point blood glucose (BG) profiles. Treatment satisfaction was determined with a self-administered questionnaire. Safety assessments included adverse events, hypoglycemic episodes, laboratory values, and physical examination findings.


RESULTS
HbA(1c) values decreased similarly for both groups from baseline (8.2 +/- 1.37% for CSII, 8.0 +/- 1.08% for MDI) to end of study (7.6 +/- 1.22% for CSII, 7.5 +/- 1.22% for MDI). The CSII group showed a trend toward lower eight-point BG values at most time points (only significant 90 min after breakfast; 167 +/- 48 vs. 192 +/- 65 mg/dl for CSII and MDI, respectively; P = 0.019). A total of 93% of CSII-treated subjects preferred the pump to their previous injectable insulin regimen for reasons of convenience, flexibility, ease of use, and overall preference. Safety assessments were comparable for both treatment groups.


CONCLUSIONS
Insulin aspart in CSII therapy provided efficacy and safety comparable to MDI therapy for type 2 diabetes. Patients with type 2 diabetes can be trained as outpatients to use CSII and prefer CSII to injections, indicating that pump therapy should be considered when initiating intensive insulin therapy for type 2 diabetes.