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Necrobiosis lipoidica is a rare, chronic skin condition predominantly associated with diabetes mellitus (known as necrobiosis lipoidica diabeticorum or NLD). [1] It can also occur in individuals with rheumatoid arthritis or without any underlying conditions ( idiopathic ). [ 2 ]
May 2018: Results of Phase 2b trial posted; October 2019: Results of Phase 3 trial presented [21] June 2020: Results of second Phase 3 trial published [22] The US Food and Drug Administration (FDA) approved abrocitinib based on evidence from three controlled clinical trials enrolling a total of 1615 participants supporting efficacy and safety. [11]
Necrobiosis is the physiological death of a cell, and can be caused by conditions such as basophilia, erythema, or a tumor. It is identified both with [ 1 ] and without necrosis . Necrobiotic disorders are characterized by presence of necrobiotic granuloma on histopathology.
AllTrials (sometimes called All Trials or AllTrials.net) is a project advocating that clinical research adopt the principles of open research.The project summarizes itself as "All trials registered, all results reported": that is, all clinical trials should be listed in a clinical trials registry, and their results should always be shared as open data.
Detailed protocols for proposed clinical studies to assess whether the initial-phase trials will expose the subjects to unnecessary risks. Other commitments are commitments to obtain informed consent from the research subjects, to obtain a review of the study by an institutional review board (IRB), and to adhere to the investigational new drug ...
As a result of pressure from HIV-infected men in the gay community, [citation needed] who demanded better access to clinical trials, the U.S. Congress passed the Health Omnibus Programs Extension Act of 1988 (Public Law 100-607) [2] which mandated the development of a database of AIDS Clinical Trials Information Services (ACTIS). [3]
The International Council on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use, a 2015 Swiss NGO of pharmaceutical companies and others, defined a contract research organization (CRO), specifically pertaining to clinical trials services as: [8]: 10 "A person or an organization (commercial, academic, or other) contracted by the sponsor to perform one or ...
Science 37 was founded in 2014 [3] by Noah Craft and Belinda Tan, working out of LA BioMed at Harbor-UCLA Medical Center. [4]Their team developed the Network Oriented Research Assistant platform, also known as the NORA platform, which includes video chat, digital self-photography, data collection, and electronic consent.