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Aug12 Enhancing Eligibility Assessment With Personal Health Records in a Fully Remote Trial

Data integrity remains a major challenge in decentralized clinical trials. Especially during eligibility assessment, ensuring comprehensive participant characterization is paramount in remote settings. To address this, our team conducted a randomized, open-label, single-center, fully remote trial i...

Chronic pain is a widespread issue that presents significant treatment challenges. There are a variety of pharmacotherapy options, with opioids among them. The two most widely prescribed opioids are hydrocodone and tramadol; however, their effectiveness is associated with CYP2D6 function, given the...

There is no accepted method to evaluate the quality of clinical trial protocol documents holistically. The Protocol Quality Rating Tool (PQRT) has been developed to assess comprehensiveness, organization, and consistency of clinical trial protocol documents. It has been tested on a library of sampl...

Digital Health Technologies (DHTs: comprising mobile applications, wearables, smart internet-connected devices) have the potential to inform patients’ functioning through remotely collected measurements and transform clinical trials with decentralized operations. Despite the strong potential, the e...

There remains a critical need to develop therapies for many diseases that currently lack treatments. This need is underscored by an appreciation that drug development, in general, has a high attrition rate, rising costs, and increased delay in bringing treatments to market. Investigator-sponsored c...

While machine learning (ML)-based predictions for in vitro ADME assays (absorption, distribution, metabolism, excretion) and noncompartmental analysis (NCA) based pharmacokinetics (PK) parameters are well established to prioritize compounds, the prediction of full plasma concentration time profil...

There is growing interest in using large language models (LLMs) to support clinical research. In particular, research on clinical trial registries has traditionally required considerable manual curation of data, which has hindered timely and up-to-date investigations on various topics. We hypothesi...

Intranasal insulin may have a use as a neuroprotective treatment for a multitude of diseases ranging from cardiac arrest to traumatic brain injury to Alzheimer’s disease. Animal data suggests that high doses of insulin may be required for neuroprotective effects. Current neuroprotective treatments ...

The use of cannabis has rapidly increased over the past decade. Understanding how the body processes cannabinoids like THC and CBD is critical for optimizing their safety and medical use. Both compounds undergo first-pass metabolism, primarily through cytochrome P450 (CYP) enzymes and UDP-glucurono...

Identification and stratification of patients with under-recognized metabolic disease is critical in addressing the Nonalcoholic Fatty Liver Disease (NAFLD)* public health crisis. Reliance on frontline healthcare recognition alone may contribute to delays in treatment, monitoring, and referrals for...

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