Athens, GA Paid Clinical Trials

This Phase 3 study is conducted to evaluate lanifibranor in adults with NASH and liver fibrosis histological stage F2 or F3 Read Less

This study is a Phase 1b/2, dose-escalation, randomized, multicenter study to assess the efficacy, safety, tolerability, and PK of ivaltinostat in combination with capecitabine and capecitabine monotherapy in patients with metastatic pancreatic adenocarcinoma whose disease has not progressed on a first line fluoropyrimidine-based chemotherapy (e.g., FOLFIRINOX). In Phase 1b, 3 dose levels of ivaltinostat will be studied in combination with a fixed dose of capecitabine to determine the RP2D of ivaltinostat. In Phase 2, patients will be randomized in a 1:1 ratio to the combination of ivaltinostat and capecitabine or to capecitabine monotherapy. A fixed dose for capecitabine 1000 mg/m2 orally twice daily will be taken on Days 1 to 14, and the RP2D of ivaltinostat will be administered intravenously once a week for 2 weeks, followed by 1 week of rest. One cycle consists of 21 days. Tumor response during study treatment will be assessed every 6 weeks up to Cycle 10, then every 9 weeks afterwards using RECIST v1.1 criteria. Read Less

Musculoskeletal injuries (MSKI) and traumatic brain injury (TBI) are the signature injuries of the ongoing military conflicts. MSKI affect 800,000 Service Members annually and TBI have impacted more than 350,000 in the past 19 years and account for 22% of all combat casualties. Concussion, a mild form of TBI, increases MSKI risk in physically active individuals, including Service Members. The overall goal of the study is to identify the neuromuscular control mechanisms that increase MSKI risk following concussion. It is hypothesized that concussed individuals will display abnormal neuromuscular function that increases MSKI risk, as compared to non-concussed controls. The study will employ a multi-center, prospective, case-matched control observational study to identify the differences in neuromuscular function following concussion that may contribute to increased MSKI risk. Once the neuromuscular control mechanisms that increase MSKI risk following concussion are identified, targeted risk mitigation strategies can be developed to reduce MSKI risk. Read Less

This pilot study aims to leverage VR's capacity to easily replicate content and allow for multiple users to share the same space and engage in activities as if they're meeting in person. Integrating VR into afterschool programs will allow youth to receive more consistent programming content, even when they are unable to travel to the physical location for the in-person meetings. Read Less

The bioactive compounds contained in tree nuts have been shown to beneficially affect cardiometabolic health outcomes. Pecans contain more total phenols, sterols, and flavonoids than any other tree nut. They also are a rich source of polyunsaturated fatty acids (PUFAs), fiber, vitamin A, vitamin E, folic acid, calcium, magnesium, phosphorus, potassium, and zinc. These bioactive components in pecans are likely the reason for the previously documented improvements in cardiometabolic health. The specific aims of this study are to: Examine the effect of pecan consumption at doses of 6%, 13%, and 20% of total energy needs on fasting and postprandial blood lipids. Examine the effect of pecan consumption at doses of 6%, 13%, and 20% of total energy needs on plasma markers associated with overall health. Examine the effect of pecan consumption at doses of 6%, 13%, and 20% of total energy needs on subjective and physiologic postprandial measures of hunger and satiety. Participants will be asked to: Consume pecans daily for 28 days or maintain their current habitual diet. Attend three short weekly visits for fasting blood craws, body measurements, and collect their next week's supply of study materials. Attend two longer (5 h) testing visits which include consuming a standard breakfast meal and having their blood drawn periodically before and after breakfast. Researchers will compare pecan LOW, pecan MID, pecan HIGH, and the Control group to examine the physiologic effects of incorporating various dosages of pecans into one's diet. Read Less

Pecan-enriched diets have been linked to improved cardiovascular health, including postprandial blood lipids and microvascular reactivity in older adults. This has led to recommendations to increase regular pecan consumption, however there is no consistent plasma measure of pecan intake. Traditionally, plasma tocopherols have been used, although they reach peak concentrations in plasma around 6-8 hours post pecan consumption, leading to high variability at 24 hours. Therefore, a more reliable biomarker of pecan consumption needs to be defined. The purpose of this study is to analyze the postprandial response of urolithins in human plasma after a pecan enriched meal and compare their appearance pattern to tocopherols. This single blind, randomized crossover trial is designed to provide two acute meal challenges for each participant (anticipated n=30, BMI 18.5 - 24.9, age 18-30y) with a washout period of ~14 days between each challenge. The intervention meal contains 68g of pecans and the control shake contains whipped cream instead of pecans, and the order of each meal will be randomly assigned. Blood draws will be collected at fasting (0-h) and every 2 hours until 8 hours postprandial, then at 12-, 24-, and 48h after the meal. The levels of urolithins and tocopherols will be quantified through liquid chromatography tandem mass spectrometry. To our knowledge, this is the first time urolithins will be tracked in plasma up to 48h post meal. This study will be used to establish of a new and more consistent dietary biomarker for pecans. Read Less

To determine the usability and technical aspects of Cordio HearO™ Read Less

180 young adult vapers who are not current smokers will participate in a baseline functional magnetic resonance imaging (fMRI) experiment, prospectively linked to a 1-year randomized controlled trial. Baseline fMRI tasks will probe critical neurocognitive markers with high potential to account for individual differences in nicotine use prognosis and responsiveness to anti-vaping public service announcements (PSAs). Participants will be assigned randomly to a survey-only control condition, or one of two intervention orders, Regular PSA then Flavor PSA, and Flavor PSA then Regular PSA (n=60 each) in a 1-year counterbalanced crossover design. Every week intervention groups will receive anti-vaping PSAs either do not specifically address harms associated with vaping flavors (regular PSAs) or PSAs with a theme focusing on the harms of flavored vape products (flavor PSAs). Participants of the intervention groups will switch PSA exposure condition after 6 months. Their evaluations of the PSAs will be assessed with brief weekly online surveys. The links to the weekly online surveys will be sent via e-mail and text which allow them to access the surveys using any device with an internet browser. During the survey, the PSA of that week will first be displayed to PSA groups (n=120), followed by a query to provide message evaluation. Afterward, the survey questions will also assess their e-cigarette, cigarette, other tobacco use, and nicotine dependence, during the past week. The control group (n=60) will complete the surveys without viewing PSAs. In-person assessments at 3, 6, 9, and 12 months will biochemically confirm nicotine exposure. Read Less

This randomized phase III trial studies how well crizotinib works in treating patients with stage IB-IIIA non-small cell lung cancer that has been removed by surgery and has a mutation in a protein called anaplastic lymphoma kinase (ALK). Mutations, or changes, in ALK can make it very active and important for tumor cell growth and progression. Crizotinib may stop the growth of tumor cells by blocking the ALK protein from working. Crizotinib may be an effective treatment for patients with non-small cell lung cancer and an ALK fusion mutation. Read Less

The Accelerating Medicines Partnership® Schizophrenia (AMP® SCZ) is a large international collaboration to develop algorithms using a set of clinical and cognitive assessments, multi-modal biomarkers, and clinical endpoints that can be used to predict the trajectories and outcomes of individuals at clinical high risk (CHR) for psychosis and to advance the testing of pharmacological interventions for CHR individuals in need. The goal is to accurately predict which individuals are likely to remit, experience an acute psychotic episode, or have intermediate outcomes that feature persistent attenuated psychotic and/or mood symptoms along with functional impairment. The prediction algorithms will have the potential to serve as early indicators of treatment efficacy in CHR persons. The AMP SCZ research program is made up of the Psychosis Risk Evaluation, Data Integration, and Computational Technologies - Data Processing, Analysis and Coordination Center (PREDICT-DPACC) and two clinical research networks, the Psychosis-Risk Outcomes Network (ProNET) and the Trajectories and Predictors in the Clinical High Risk for Psychosis Population: Prediction Scientific Global Consortium (PRESCIENT) networks. The two clinical research networks will recruit a large cohort of CHR young people aged 12-30 years (n=1,977) and healthy control (HC) participants (n=640) across 42 participating investigative sites from 13 countries. CHR participants will complete screening, baseline assessments and a battery of follow-up assessments across 18 - 24 months. HC participants will complete screening and baseline assessments and a subset (5 per site) will complete month 2, 12 and 24 visits. Read Less

Adding cottonseed oil to the diet has been shown to improve cholesterol profiles and other markers of chronic disease risk in both healthy and at-risk adults. However, CSO has only been tested in the context of high-fat diets. The goal of this clinical trial is to learn about the health effects of lower amounts of cottonseed oil (CSO) added to the diet in adults at increased risk for cardiovascular disease. The main questions it aims to answer are: How do different amounts of CSO in the diet affect fasting cholesterol profiles and markers of liver function? How do different amounts of CSO in the diet affect fasting and post-meal markers of lipid metabolism (i.e. triglycerides) and glycemic control (i.e. blood sugar and insulin)? How do different amounts of CSO in the diet affect fasting and post-meal markers of chronic disease risk factors such as oxidative stress, inflammation, coagulation potential, and appetite control? Participants will be asked to: Consume provided breakfast shakes and snacks daily for 28-days. Attend three weekly short visits for fasting blood draws, body measurements, and collect the next week of study materials. Attend two longer (5.5 h) testing visits which include eating a standardized breakfast meal and having blood drawn periodically before and after breakfast. Researchers will compare CSO LOW, CSO MID, CSO HIGH, and Control groups (receiving a mixture of oils) to see if lower doses of CSO in the diet impart the same health benefits as previously shown with high doses of CSO. Read Less

The goal of this real-world, multi-center, randomized, outpatient study is to assess the effectiveness of the Biofourmis cloud based BiovitalsHFTM platform to recommend optimal titration of Guideline-Directed Medical Therapy (GDMT) for heart failure with reduced ejection fraction (HFrEF) subjects. Read Less