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96 results for “Safety Analysis”
Data from: Improving public safety through spatial synthesis, mapping, modeling, and performance analysis of emergency evacuation routes in California localities
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Data from: Equivalence analysis to support environmental safety assessment: using nontarget organism count data from field trials with cisgenically modified potato
This paper considers the statistical analysis of entomological count data from field experiments with genetically modified (GM) plants. Such trials are carried out to assess environmental safety. Potential effects on nontarget organisms (NTOs), as indicators of biodiversity, are investigated. The European Food Safety Authority (EFSA) gives broad guidance on the environmental risk assessment (ERA) of GM plants. Field experiments must contain suitable comparator crops as a benchmark for the assessment of designated endpoints. In this paper, a detailed protocol is proposed to perform data analysis for the purpose of assessing environmental safety. The protocol includes the specification of a list of endpoints and their hierarchical relations, the specification of intended levels of data analysis, and the specification of provisional limits of concern to decide on the need for further investigation. The protocol emphasizes a graphical representation of estimates and confidence intervals for the ratio of mean abundances for the GM plant and its comparator crop. Interpretation relies mainly on equivalence testing in which confidence intervals are compared with the limits of concern. The proposed methodology is illustrated with entomological count data resulting from multiyear, multilocation field trials. A cisgenically modified potato line (with enhanced resistance to late blight disease) was compared to the original conventional potato variety in the Netherlands and Ireland in two successive years (2013, 2014). It is shown that the protocol encompasses alternative schemes for safety assessment resulting from different research questions and/or expert choices. Graphical displays of equivalence testing at several hierarchical levels and their interpretation are presented for one of these schemes. The proposed approaches should be of help in the ERA of GM or other novel plants.
Data from: Efficacy and safety of bevacizumab plus erlotinib versus bevacizumab or erlotinib alone in the treatment of non-small-cell lung cancer: a systematic review and meta-analysis
Objectives: Bevacizumab and erlotinib inhibit different tumour growth pathways, and both exhibit beneficial effects in the treatment of non-small-cell lung cancer (NSCLC). However, the efficacy of bevacizumab in combination with erlotinib remains controversial. Therefore, we conducted a meta-analysis to compare combination treatment with bevacizumab and erlotinib to bevacizumab or erlotinib monotherapy in the treatment of NSCLC. Methods: Randomised controlled trials (RCTs) published in PubMed, Web of Science and EMBASE were systematically reviewed. The main outcome measures included overall survival (OS), progression-free survival (PFS), overall response rate (ORR) and adverse events. Results were expressed as HRs or risk ratios (RRs) with 95% CIs. Results: 5 RCTs involving a total of 1736 patients were included in this meta-analysis. The combination of bevacizumab and erlotinib significantly improved PFS (HR=0.63, 95% CI 0.53 to 0.75; p=0.000) and the ORR (RR=1.91, 95% CI 1.19 to 3.06; p=0.007) in the second-line treatment of NSCLC compared with bevacizumab or erlotinib alone. However, no significant difference in OS was observed between the combination and monotherapy groups (HR=0.96, 95% CI 0.83 to 1.11; p=0.573). A subgroup analysis has shown that the greatest PFS benefit was associated with an age of <65 years(HR=0.74, 95% CI 0.57 to 0.96; p=0.026), Asian/Pacific Islander ethnicity (HR=0.23, 95% CI 0.10 to 0.54; p=0.001), Eastern Cooperative Oncology Group performance status (ECOG PS) 1 (HR=0.82, 95% CI 0.68 to 0.98; p=0.033), stage IIIB or IV disease (HR=0.68, 95% CI 0.57 to 0.82; p=0.000) and no history of smoking (HR=0.48, 95% CI 0.32 to 0.71; p=0.000). The incidence of grade 3/4 adverse events such as rash and diarrhoea was higher in the combination group than in the monotherapy group. Conclusions: The addition of bevacizumab to erlotinib can significantly improve PFS and the ORR in the second-line treatment of NSCLC with an acceptable and manageable risk of rash and diarrhoea. Further well-conducted, large-scale trials are needed to validate these findings.
Replication package for the article "Combining STPA and BDD for Safety Analysis and Verification in Agile Development: A Controlled Experiment"
<p>This replication package includes all the instruments we used in our experiment. </p>
Supplementary Appendix: Efficacy and safety analysis of a new oral testosterone undecanoate (TU) formulation following two years of treatment in hypogonadal men
<p>Supplementary Table 1. Change from Baseline in Efficacy and Safety Parameters over Two<br> Years of Oral TU Treatment – Confirmatory Analysis</p> <p>Supplementary Figure 1. Study Dose Titration Scheme for Days 0-180</p> <p>Supplementary Figure 2. Study Dose Titration Scheme for Days 180 and 270</p> <p>Supplementary Figure 3. Study Dose Titration Scheme for Days 365 Through End of Study</p>
VISION and VQI Paclitaxel Safety Analysis
ClinicalTrials.gov study NCT04204564. IPD Sharing: NO. Countries: 0. Publications: 14.
A Safety Analysis of Oral Prednisone as a Pre-Treatment for Rituximab in Rheumatoid Arthritis.
ClinicalTrials.gov study NCT00580229. IPD Sharing: NO. Countries: 1. Publications: 0.
Retrospective Analysis of the Safety and Efficacy of Hydroxychloroquine in Immune Thrombocytopenia
ClinicalTrials.gov study NCT01549184. IPD Sharing: Not stated. Countries: 0. Publications: 1.
Safety and Efficacy Analysis of FRED® Embolic Device in Aneurysm Treatment
ClinicalTrials.gov study NCT02921698. IPD Sharing: NO. Countries: 0. Publications: 2.
Main Study: A Study to Evaluate the Effectiveness and Safety of GAL1906 for Correction of Wrinkles in the décolletage Area Sub-study: A Follow-up Study to Evaluate the Analysis of Mammograms Following
ClinicalTrials.gov study NCT04717934. IPD Sharing: NO. Countries: 1. Publications: 0.
Data from: Equivalence analysis to support environmental safety assessment: using nontarget organism count data from field trials with cisgenically modified potato
Open the record for dataset details and reuse information.
Data from: Efficacy and safety of bevacizumab plus erlotinib versus bevacizumab or erlotinib alone in the treatment of non-small-cell lung cancer: a systematic review and meta-analysis
Open the record for dataset details and reuse information.
Safety and Transcriptome Analysis of Brucella Live Attenuated Vaccine Strain S2 on Cynomolgus Monkeys
GEO Series GSE165283. Macaca fascicularis. 6 samples. Type: Expression profiling by high throughput sequencing.
Implications of transcriptomics, proteomics and metabolomics analysis of maize seeds for food safety
GEO Series GSE15853. Zea mays. 36 samples. Type: Expression profiling by array.
Chromosomal meiotic segregation, embryonic developmental kinetics and DNA (hydroxy)methylation analysis reassure the safety of human oocyte vitrification in a high security closed system
GEO Series GSE63866. Homo sapiens. 48 samples. Type: Genome variation profiling by genome tiling array.
Data from: Safety and efficacy of dual antiplatelet pretreatment in ischemic stroke patients treated with intravenous thrombolysis: a systematic review and meta-analysis
Objective: Conflicting data exist regarding the safety and efficacy of IV thrombolysis (IVT) in acute ischemic stroke (AIS) patients receiving dual antiplatelet pretreatment (DAPP). The aim of the present systematic review and meta-analysis is to assess the safety and outcome of DAPP history among AIS patients treated with IVT. Methods: We performed a comprehensive literature review to identify studies that investigated the safety and efficacy of DAPP among AIS patients treated with IVT. Results: We identified 9 studies comprising 66,675 patients. In unadjusted analyses, DAPP was associated with higher likelihood of pooled symptomatic intracranial hemorrhage (sICH, OR = 2.26, 95% CI 1.39–3.67) and 3-month mortality (OR = 1.47, 95% CI 1.27–1.73). DAPP was also related to higher odds of sICH according to SITS-MOST (OR = 2.71, 95% CI 2.05–3.59), ECASS II (OR=2.23, 95% CI 1.46–3.40) and NINDS (OR=1.59, 95% CI 1.38–1.83) definitions. There was no association between DAPP and 3-month favorable functional outcome (FFO, mRS 0-1), and 3-month functional independence (FI, mRS 0-2). In adjusted analyses, history of DAPP was not associated with pooled sICH (OR=2.03, 95% CI 0.75–5.25), 3-month mortality (OR=1.11, 95% CI 0.87–1.40), 3-month FFO (OR=0.92, 95% CI 0.77–1.09), and 3-month FI (OR=1.01, 95% CI 0.89–1.15). Conclusions: After adjustment for potential confounders DAPP appears not to be associated with higher risk of adverse outcomes in AIS patients treated with IVT.
Retrospective Analysis of the Safety and Effectiveness of Using the Silicone Block in Penile Surgery
ClinicalTrials.gov study NCT02477189. IPD Sharing: Not stated. Countries: 1. Publications: 0.
Retrospective Analysis for the ClotTriever Catheter to Investigate Safety and Effectiveness in the Treatment of Acute and Subacute Iliofemoral Deep Vein Thrombosis (DVT)
ClinicalTrials.gov study NCT05740410. IPD Sharing: NO. Countries: 1. Publications: 0.
Safety Analysis of Intravenous Rapid Infusion of Obinutuzumab in Patients With B-cell Non-Hodgkin's Lymphoma in China
ClinicalTrials.gov study NCT05510219. IPD Sharing: Not stated. Countries: 1. Publications: 0.
Perception of Stress and Safety Culture: Analysis of Critical Factors in Healthcare (SICURES)
ClinicalTrials.gov study NCT07341295. IPD Sharing: Not stated. Countries: 1. Publications: 0.
ScienceDex guides
Understand access before you commit
These curated guides explain access requirements, typical timelines, costs, and reuse considerations for widely used research datasets.
Allen Brain Atlas
Allen Brain Atlas is an Allen Institute collection of brain map atlases, datasets, APIs, and analysis tools covering mouse, human, and non-human primate brain resources.
Annotated Behaviour and Observability Dataset (ABODe)
ABODe is a University of Edinburgh DataShare dataset for behavior classification in group-housed mice using home-cage video, identities, bounding boxes, ground-plate positions, and annotator labels.
DANDI Archive for NWB datasets
DANDI is a BRAIN Initiative archive for publishing and sharing neurophysiology data, including electrophysiology, optophysiology, and behavioral data packaged as NWB and related standards.
International Brain Laboratory public data
The International Brain Laboratory public data releases expose standardized mouse decision-making experiments, including Neuropixels recordings, widefield calcium imaging, behavior, and session metadata accessed through the ONE API.
OpenNeuro
OpenNeuro is a free, open platform for sharing neuroimaging datasets, with public search, dataset pages, and download paths for web, S3, DataLad, and the OpenNeuro CLI.