Columbia, MO Paid Clinical Trials

The main purpose of this study is to measure how well imlunestrant works compared to standard hormone therapy in participants with early breast cancer that is estrogen receptor positive (ER+) and human epidermal receptor 2 negative (HER2-). Participants must have already taken endocrine therapy for two to five years and must have a higher-than-average risk for their cancer to return. Study participation could last up to 10 years. Read Less

This study will evaluate the safety and immunogenicity of the mRNA-1273.214 vaccine for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) variant of concerns (VOCs) in participants aged 6 months to <6 years, when administered as a primary series in SARS-CoV-2 vaccine-naïve participants (Part 1) and a single booster dose (BD) given to participants who previously received 2 doses of the mRNA-1273 vaccine as a primary series (Part 2); and will evaluate the safety and immunogenicity of the mRNA-1273.815 vaccine, when administered as a BD in participants aged 6 months to <6 years (Part 3) and when administered to SARS-CoV-2 vaccine-naïve participants aged 2 years to <5 years of age (Part 4). Read Less

The main purpose of this study is to assess the efficacy and safety of volrustomig compared to observation in participants with unresected locally advanced head and neck squamous cell carcinoma (LA-HNSCC) who have not progressed after receiving definitive concurrent chemoradiotherapy (cCRT). Read Less

Strong evidence supports the association between high fiber (HiFi) diets (e.g. legumes, nuts, vegetables) and a reduced risk for chronic conditions such as cardiovascular disease (CVD), type 2 diabetes and some forms of cancer. However, the current U.S. average consumption of dietary fiber of 17g/day is significantly below the recommendation level of 25g/d for women and 38g/d for men. Furthermore, fiber fermentation to produce short chain fatty acid (SCFA) products and alterations in microbial composition and activity may be mechanisms linking a HiFi diet to improved health. Importantly, much of the data, including findings supporting a beneficial role of SCFA have been derived from animal studies. Human studies are now needed to advance the understanding of the translational significance of rodent studies and the potential benefit of fiber on microbial metabolites and cardiometabolic health, glucose regulation, appetite and satiety. The central hypothesis is that that the mechanisms by which dietary fiber provides metabolic benefit include direct physical effects in the upper gastrointestinal tract to slow nutrient absorption, and indirect effects to reduce food intake mediated by SCFA-induced secretion of intestinal hormones resulting in increased satiety. Design: Using fiber derived from peas, Aim 1 will test the effect of a HiFi diet on appetite, satiety, and cardiometabolic health and whether elevated SCFA concentration mediates improved satiety in 44 overweight/obese subjects randomly assigned to receive either a high fiber or a low fiber dietary intervention for four weeks in a parallel arm-repeated measures design. Aim 2 will quantitate the changes in microbial composition and colonic SCFA production rate during HiFi feeding and whether any changes are potential mediators of observed benefits on satiety and cardiometabolic risk factors in 26 subjects assigned to receive a high fiber intervention for 3 weeks in a repeated measures design. Relevance: These studies will significantly expand the understanding of mechanisms by which dietary fiber improves satiety and cardiometabolic health in humans. Read Less

The primary purpose of this study is to evaluate the effects of Fluticasone Furoate (FF)/ Umeclidinium (UMEC)/ Vilanterol (VI) on lung function compared with FF/VI after 24 weeks of treatment. Read Less

The purposes of this study are to compare the impact of a hybrid of telehealth and in-person physical therapy services to in-person services alone on the in-home functional skills of children with moderate to severe disability. This is a mixed methods study. Read Less

The main purpose of the study is to evaluate the effectiveness, of the ACCELERATE model of care to achieve HIV viral suppression at Week 24. The study will also assess the acceptability, appropriateness, feasibility, and sustainability of the ACCELERATE model of care. The ACCELERATE model combines a standardized method for outreach, the use of telehealth for rapid access to an HIV care provider, a simplified pre-approved HIV regimen, a free 30-day medication starter supply, and re-linkage to medical care. Read Less

This is a long-term, multi-center, observational study in children 2.5 to <17 years with achondroplasia (ACH). The objective is to evaluate growth, ACH-related medical complications, assessments of health-related quality of life, body pain, functional abilities, cognitive functions, and treatments of study participants. No study medication will be administered. Read Less

This phase III trial compares an additional support program (text message reminders and/or telephone-based counseling) with usual care in making sure breast cancer patients take their endocrine therapy medication as prescribed (medication adherence). Medication adherence is how well patients take the medication as prescribed by their doctors, and good medical adherence is when patients take medications correctly. Poor medication adherence has been shown to be a serious barrier to effective treatment for hormone receptor positive breast cancer patients. Adding text message reminders and/or telephone-based counseling to usual care may increase the number of days that patients take their endocrine therapy medication as prescribed. Read Less

This phase II trial studies how well genetic testing works in guiding treatment for patients with solid tumors that have spread to the brain. Several genes have been found to be altered or mutated in brain metastases such as NTRK, ROS1, CDK, PI3K, or KRAS G12C. Medications that target these genes such as abemaciclib, paxalisib, entrectinib and adagrasib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Genetic testing may help doctors tailor treatment for each mutation. Read Less

Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in chemotherapy, such as temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. It is not yet known whether giving radiation with concomitant and adjuvant temozolomide versus radiation with adjuvant PCV is more effective in treating anaplastic glioma or low grade glioma. Read Less

The long-term goal of this research is to improve activity performance and reduce motor impairment in individuals with stroke. Contemporary stroke rehabilitation focuses on remediation of post-stroke impairments with a false assumption that reduction in impairments will automatically lead to improvements in activity performance. Specifically, stroke rehabilitation is focused primarily on the use of task-specific training (TST), which recent research has found to yield negligible improvement in upper extremity motor function often consistent with or less than control conditions. These protocols are time intensive and often do not lead to transfer of training effects to improvement in activity performance. This is a common issue that has been evidenced in longitudinal studies of individuals with stroke; over half of stroke survivors continue to be dependent on others for the most basic of life activities after rehabilitation. Decreases in activity performance further contribute to lower life satisfaction, quality of life, and participation in daily life. The goal of this proposed project is to evaluate the efficacy of a clinically-feasible metacognitive strategy training (MCST) intervention, the Cognitive Orientation to daily Occupational Performance (CO-OP) approach, to improve activity performance and reduce stroke impairment for individuals with sub-acute stroke. Recent evidence highlights two primary issues in stroke rehabilitation. 1) Interventions are needed that directly target activity performance. Gains in upper extremity function, even using the most contemporary approaches, are not translating to meaningful gains in activity performance. 2) Interventions need to be clinically feasible for future implementation. In recent stroke rehabilitation clinical trials, participants received an average of over 30 hours of therapy in only one treatment modality. Individuals in stroke rehabilitation receive a median of only 6 outpatient visits across all health care specialties combined (OT, PT, SLP, physiatrist). Metacognitive strategy training (MCST), specifically the Cognitive Orientation to daily Occupational Performance (CO-OP) approach, is a potential solution to address both of these gaps. CO-OP is a performance-based, problem-solving approach that enables participants to improve task performance through cognitive strategy use. In the exploratory clinical trial for individuals with sub-acute stroke (n=26), the study compared ten, 45-minute sessions of MCST (CO-OP) with dose-matched outpatient usual care outpatient occupational therapy (OT). The MCST (CO-OP) group demonstrated a large effect over usual care on objective measures of trained functional activities (d=1.6) and untrained functional activities (d = 1.1). The MCST group also demonstrated a moderate effect over usual care outpatient OT on improving motor function (r = 0.3). The goal of this proposed project is to determine the efficacy of MCST to improve activity performance and to reduce motor impairments in individuals with subacute stroke. A single-blind, parallel, randomized clinical trial will be conducted with individuals with sub-acute stroke. Participants will be randomized to a 10-session MCST (CO-OP) treatment group or to a dose matched usual care outpatient OT control group. Data will be collected pre-intervention, post-intervention, and at 3-months post-intervention assessment. Our central research hypothesis is that MCST will produce a significant improvement on objective and subjective measures of activity performance (trained and untrained goals) and reduce motor impairment in comparison to a usual care OT group. Objective 1: Evaluate the efficacy of MCST to improve subjective and objective activity performance in individuals with subacute stroke. Primary Endpoint: MCST will have a greater positive effect compared to usual care OT on subjective and objective activity performance of trained goals. Primary Endpoint: MCST will have a greater positive effect compared to usual care OT on subjective and objective activity performance of untrained activity goals to demonstrate transfer of the treatment effect. Secondary Endpoint: MCST will have a greater positive effect compared to usual care OT on subjective stroke recovery (participation and role functioning) Objective 2: Evaluate the efficacy of MCST to improve motor function in individuals with subacute stroke. Primary Endpoint: MCST group will have a greater positive effect compared to usual care OT on reducing motor impairment. Secondary Endpoint: MCST will have a greater positive effect compared to usual care OT on subjective stroke recovery (physical functioning) Read Less