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1,055
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1,055 results for “FDA”
Peptidomimetics-based identification of FDA approved compounds inhibiting IRE1 activity: Simulation Data
<p>Protocols and data sets for docking and MD simulations of Methotrexate, Cefoperazone, Folinic acd and Folic acid interaction with IRE1. All docking data based on Glide (Schrödinger), and all MD simulations are based on the Gromacs software. 2D interaction maps from the initial docking of the four molecules to the four Lysine sites, and from snapshots every 100 ns of the 500 ns MD simulations of the molecules interacting with Lys599 (kinase site) and Lys907 (RNase site). 2D interaction maps produced using Schrödinger. </p>
Water networks in complexes between proteins and FDA-approved drugs
<p>Dataset to accompany manuscript - prepared protein-ligand complexes</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.
Fluid simulation of the FDA nozzle benchmark
Open the record for dataset details and reuse information.
Investigator Initiated Trial Using Dry Eye Surveys to Evaluate and Better Understand FDA Approved Acoltremon Treatment for Dry Eye Disease in Real World Treatment Settings (DESERT)
ClinicalTrials.gov study NCT07281950. IPD Sharing: UNDECIDED. Countries: 1. Publications: 0.
To Compare the Safety and Efficacy of Perrigo's Product to an FDA Approved Product for the Treatment of Glaucoma or Ocular Hypertension in Both Eyes
ClinicalTrials.gov study NCT04024072. IPD Sharing: NO. Countries: 1. Publications: 0.
[Trial of device that is not approved or cleared by the U.S. FDA]
ClinicalTrials.gov study NCT05251077. IPD Sharing: Not stated. Countries: 0. Publications: 0.
[Trial of device that is not approved or cleared by the U.S. FDA]
ClinicalTrials.gov study NCT06560177. IPD Sharing: Not stated. Countries: 0. Publications: 0.
[Trial of device that is not approved or cleared by the U.S. FDA]
ClinicalTrials.gov study NCT05976425. IPD Sharing: Not stated. Countries: 0. Publications: 0.
Effects of FDA Authorized Smokeless Tobacco Claims Among US Adults Who Smoke Cigarettes
ClinicalTrials.gov study NCT06927700. IPD Sharing: YES. Countries: 1. Publications: 0.
To Compare the Efficacy and Safety of Perrigo's Product to an FDA Approved Product for the Treatment of Glaucoma or Ocular Hypertension in Both Eyes
ClinicalTrials.gov study NCT04944290. IPD Sharing: NO. Countries: 1. Publications: 0.
A Study to Compare the Safety and Effectiveness of a Non-FDA Approved Device Dermal Gel Extra (DGE) and an FDA Approved Device for the Correction of Nasolabial Folds (NLFs)
ClinicalTrials.gov study NCT00444626. IPD Sharing: Not stated. Countries: 1. Publications: 0.
[Trial of device that is not approved or cleared by the U.S. FDA]
ClinicalTrials.gov study NCT06571370. IPD Sharing: Not stated. Countries: 0. Publications: 0.
A Phase II Trial of MB-6 Plus FOLFOX4 for Metastatic Colorectal Cancer (FDA IND 103675)
ClinicalTrials.gov study NCT01047475. IPD Sharing: Not stated. Countries: 1. Publications: 0.
[Trial of device that is not approved or cleared by the U.S. FDA]
ClinicalTrials.gov study NCT07121933. IPD Sharing: Not stated. Countries: 0. Publications: 0.
A Safety and Efficacy Comparison of BLI4700 Bowel Preparation Versus an FDA-approved Comparator in Adult Subjects Prior to Colonoscopy
ClinicalTrials.gov study NCT03261960. IPD Sharing: UNDECIDED. Countries: 1. Publications: 0.
To Compare the Safety and Efficacy of Perrigo's Product to an FDA Approved Product for the Treatment of Secondarily Infected Traumatic Skin Lesions
ClinicalTrials.gov study NCT04155203. IPD Sharing: NO. Countries: 1. Publications: 0.
FDA Cigarette Warning Labels: Eye Tracking Study
ClinicalTrials.gov study NCT04936724. IPD Sharing: YES. Countries: 1. Publications: 0.
Study 301: BLI4900 Versus an FDA-approved Comparator in Adult Subjects Prior to Colonoscopy
ClinicalTrials.gov study NCT04446299. IPD Sharing: NO. Countries: 1. Publications: 0.
[Trial of device that is not approved or cleared by the U.S. FDA]
ClinicalTrials.gov study NCT04771182. IPD Sharing: Not stated. Countries: 0. 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.