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Browse 5,093 clinical trials for multiple sclerosis. Find studies that match your criteria and connect with research centers.
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NCT04267861
Background: Immunotherapy drugs use a person s own immune system to help fight cancer. These drugs work better for some people than others. The drug M7824 has helped some people with cancer. But it can cause side effects. Researchers want to learn all the side effects that M7824 can cause. Once they do, they can prevent or reduce these side effects in future cancer treatments. This will lead to better overall outcomes for people with cancer. Objective: To make a thorough list of adverse events in people with cancer being treated with systemic therapies including M7824 at the National Cancer Institute (NCI). Eligibility: Participants previously enrolled in NCI protocols #15-C-0179 and #18-C-0056 Design: All needed data have already been collected. These data are stored in existing records and databases. Researchers will review the medical records of adults with cancer who were enrolled in the above protocols. The data collected will be relevant to the specific objectives being addressed. Data will be collected only if 2 conditions are met. One, the principal investigator gave permission for use of the data gathered in the trial. Two, the participants of the trial did not opt out of future use of the data. Other protocols may be added. This will be done with an amendment. ...
NCT04100057
Recent findings suggest that sleep disruption may contribute to the generation and maintenance of neuropsychiatric symptoms including anxiety, depression, agitation, irritation, and apathy while treating sleep disruption reduces these symptoms. Impairments in the neural systems that support emotion regulation may represent one causal mechanism mediating the relationship between sleep and emotional distress. However, this model has not yet been formally tested within a sample of individuals with or at risk for developing Alzheimer's Disease (AD) This proposal aims to test a mechanistic model in which sleep disturbance contributes to neuropsychiatric symptoms through impairments in fronto-limbic emotion regulation function in a sample of individuals at risk for developing, or at an early stage of AD. This study seeks to delineate the causal association between sleep disruption, fronto-limbic emotion regulation brain function, and neuropsychiatric symptoms. These aims will be achieved through a mechanistic, randomized 2-arm controlled trial design. 150 adults experiencing sleep disturbances and who also have cognitive impairment with the presence of at least mild neuropsychiatric symptoms will be randomized to receive either a sleep manipulation (Cognitive Behavioral Therapy for Insomnia CBT-I; n=75) or an active control (n=75). CBT-I improves sleep patterns through a combination of sleep restriction, stimulus control, mindfulness training, cognitive therapy targeting dysfunctional beliefs about sleep, and sleep hygiene education. Neuropsychiatric symptoms, fronto-limbic functioning, and sleep disruption will be assessed at baseline and at the end of the sleep manipulation through functional Magnetic Resonance Imaging (fMRI), clinical interviews, PSG recordings, and self-report questionnaires. Neuropsychiatric symptoms (anxiety and depression) and sleep disturbance (actigraphy, Insomnia Severity Index, and sleep diaries) will be assayed at baseline and each week throughout the sleep manipulation to assess week-to-week changes following an increasing number of CBT-I sessions. Wristwatch actigraphy will be acquired from baseline to the end of the sleep manipulation at week 11. Neuropsychiatric symptoms and sleep will be assessed again at six months post-manipulation.