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738 results for “Adverse events”
Impact of a Prehospital Sepsis Protocol on Timely Antibiotic Administration and Subsequent Adverse Events
ClinicalTrials.gov study NCT05502107. IPD Sharing: YES. Countries: 1. Publications: 1.
Preventing Adverse Cardiac Events in COPD
ClinicalTrials.gov study NCT03917914. IPD Sharing: NO. Countries: 4. Publications: 2.
Adverse Events Related to Low Dose Atropine
ClinicalTrials.gov study NCT05683535. IPD Sharing: NO. Countries: 1. Publications: 10.
Effectiveness of a Proactive Cardiovascular Primary Prevention Strategy, With or Without the Use of Coronary Calcium Screening, in Preventing Future Major Adverse Cardiac Events
ClinicalTrials.gov study NCT03439267. IPD Sharing: NO. Countries: 1. Publications: 1.
Immune Related-adverse Events in Patients Receiving Immune Checkpoint Inhibitors
ClinicalTrials.gov study NCT04268368. IPD Sharing: UNDECIDED. Countries: 1. Publications: 1.
Cross Checking to Reduce Adverse Events in the Emergency Department
ClinicalTrials.gov study NCT02356926. IPD Sharing: Not stated. Countries: 1. Publications: 2.
The Implementation of the Classification of Intraoperative Adverse Events (ClassIntra) for Neurosurgical Procedures
ClinicalTrials.gov study NCT04956835. IPD Sharing: NO. Countries: 1. Publications: 2.
QPI-1002 Phase 3 for Prevention of Major Adverse Kidney Events (MAKE) in Subjects at High Risk for AKI Following Cardiac Surgery
ClinicalTrials.gov study NCT03510897. IPD Sharing: Not stated. Countries: 11. Publications: 3.
Data from: Adverse events associated with risdiplam use
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Data from: Methods for estimating causal relationships of adverse events with dietary supplements
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Data from: A curated and standardized adverse drug event resource to accelerate drug safety research
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Data from: BLT-immune humanized mice as a model for nivolumab induced immune-mediated adverse events: Comparison of the NOG and NOG-EXL strains
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Data from: Adverse events related to intravenous antibiotic therapy: a prospective observational study in the treatment of infective endocarditis
Objective: The goal of this prospective observational present study was to identify adverse events (AEs) related to the use of intravenous access sites for infective endocarditis (IE) treatment in a tertiary care hospital that can occur during patient care that cannot be attributed to the underlying disease and may result in lengthening of hospital stay or death. Design: This is an observational, analytical and prospective study on AEs resulting from the use of intravenous access sites in patients under antimicrobial treatment for IE. Patients enrolled in the International Collaboration on Endocarditis (ICE) study had their peripheral, short term central catheters (CVC) and peripherally inserted central catheters (PICC) monitored for AEs. Setting: Tertiary care hospital for cardiac surgery in Rio de Janeiro, Brazil. Patients: Patients over 18 years of age, hospitalized in 2009 and 2010 with definite criteria for IE by the modified Duke criteria were included. Main outcome measures: Adverse events related to intravenous catheters: erythema and infiltration, fever, obstruction, externalization and blood stream infection. Results: Thirty-seven episodes of IE in 35 patients were studied. Mean age was 44.32 ± 15.2 years; 22 (63%) were male. 253 vascular catheters were studied, 148 peripheral, 85 CVC (21 of which for haemodialysis) and 20 PICC. The most frequent AEs were "erythema" and "infiltration" for peripheral catheters, "fever" for CVCs, and "obstruction" and "externalization" for PICCs. The number of catheter-days was 360 for peripheral catheters, 1.156 for CVC and 420 for PICC. Kaplan Meier curves for CVC and PICC showed statistical difference for obstruction (p<0.001) in PICCs. More bacteraemia occurred in CVC compared to PICC. Conclusion: The choice of intravenous access sites is critical in the treatment of IE. Close observation for adverse events and stricter implementation of infection control measures and better manipulation of catheters are suggested.
Fecal calprotectin as a predictor of gastrointestinal immune-related adverse events (CF-19): A prospective study - Excel data and supplementary tables
<p class="cuerpo"><b>Background: </b>Colitis is a frequent immune-related toxicity, without any biomarker that may predict its onset. It is endoscopically similar to intestinal inflammatory diseases, where fecal calprotectin (FC) is used as a biomarker to early-detect a relapse. We found contradictory evidence about FC and immunotherapy and no prospective study was already published. </p> <p class="cuerpo"><b>Methods:</b> We present an analytical, observational and prospective study of one year's duration. We analyzed FCbasal, and then prior to each cycle until the sixth, ending with quarterly follow-up. For evaluating the predictive value of FC we estimated the area under the ROC curve for basal absolute values and for each cycle, and calculated its relative percentage change with respect to basal. We also planned to estimate sensitivity, specificity and predictive values indexes for different cut-off points. Because of lack of recruitment we did a preliminary analysis at the end of the initially estimated period before suggesting its prolongation. </p> <p class="cuerpo"><b>Results:</b> 24 patients were included (19 male), diagnosed from lung cancer (n=15), head and neck, renal, bladder and colorectal cancer (n=2, each), melanoma (n=1). They were treated with Anti PD-1/PDL-1 mono therapy (n=18), combo with chemo (n=2), or combo with anti-CTLA4 (n=2). Three patients had G1 colitis and two, >=G2, all treated with anti-PD1 and before 6th cycle, as described on literature. ROC curve presents AUC 0,559 (CI95%:0,32-0,798) and RR for colitis taking FC value is 1,001 for each 10 units (p=0,493).</p> <p class="cuerpo"><b>Conclusion:</b> Even though we must take into account the limitations of the study we cannot conclude that FC could be used as a predictor for detecting immune-mediated colitis. </p>
Data from: Immunotherapy-related adverse events (irAEs): extraction from FDA drug labels and comparative analysis
Objectives: Immune checkpoint inhibitors (ICIs) have dramatically improved outcomes in cancer patients. However, ICIs are associated with significant immune-related adverse events (irAEs) and the underlying biological mechanisms are not well-understood. To ensure safe cancer treatment, research efforts are needed to comprehensively detect and understand irAEs. Materials and Methods: We manually extracted and standardized irAEs from FDA drug labels for six FDA-approved ICIs. We compared irAE profile similarities among ICIs and 1,507 FDA-approved non-ICI drugs. We investigated how irAEs have differential effects on human organs by classifying irAEs based on their targeted organ systems. Finally, we identified broad-spectrum (non-target specific) and narrow-spectrum (target-specific) irAEs. Results: A total of 893 irAEs were extracted. 31.4% irAEs were shared among ICIs as compared to the 8.0% between ICIs and non-ICI drugs. irAEs were resulted from both on- and off-target effects: irAE profiles were more similar for ICIs with same target than different targets, demonstrating the on-target effects; irAE profile similarity for ICIs with the same target is less than 50%, demonstrating unknown off-target effects. ICIs significantly target many organ systems, including endocrine system (3.4-fold enrichment), metabolism (3.7-fold enrichment), immune system (3.6-fold enrichment) and autoimmune system (4.8-fold enrichment). We identified 21 broad-spectrum irAEs shared among all ICIs, 20 irAEs specific for PD-L1/PD-1 inhibition, and 28 irAEs specific for CTLA-4 inhibition. Discussion and Conclusion: Our study presents the first effort toward building a standardized database of irAEs. The extracted irAEs can serve as a goldstandard for automatic irAE extractions from other data resources and set a foundation to understand biological mechanisms of irAEs.
Comparative Study of Oral Atogepant Versus Oral Topiramate to Assess Adverse Events in Adult Participants With Migraine
ClinicalTrials.gov study NCT05748483. IPD Sharing: YES. Countries: 12. Publications: 0.
The Benefit of 5% IVIG for Patients With Primary Immunodeficiency Disorders Who Experience Adverse Events on 10% IVIG Preparations
ClinicalTrials.gov study NCT03339778. IPD Sharing: Not stated. Countries: 0. Publications: 4.
The Effect of Caffeine on Postextubation Adverse Respiratory Events in Children With Obstructive Sleep Apnea (OSA).
ClinicalTrials.gov study NCT00273754. IPD Sharing: Not stated. Countries: 1. Publications: 0.
A Study to Evaluate the Change in Disease State and Adverse Events in Adult Participants With Polymyalgia Rheumatica (PMR) Dependent on Glucocorticoid Treatment, Receiving Subcutaneous Injections of A
ClinicalTrials.gov study NCT04972968. IPD Sharing: YES. Countries: 15. Publications: 0.
A Contrast Medium Sparing Strategy Using Automated CO2 Injection During PVI for Prevention of Major Adverse Kidney Events (MAKE)
ClinicalTrials.gov study NCT06656988. IPD Sharing: YES. Countries: 2. Publications: 0.
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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.
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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.