All Clinical Trials

The goal of this study is to understand and improve the breast surgical decision-making process for young women newly diagnosed with breast cancer. As part of this study, the investigators will evaluate the impact and use a web-based tool called CONSYDER that is designed to provide useful information to young breast cancer patients. It is also meant to improve communication between young women and their surgeons with the purpose of helping patients make appropriate surgical decisions. Participants will complete surveys approximately within 1 week of the surgical consult and approximately 6 months after surgery. Patients who receive neoadjuvant chemotherapy will also be surveyed after the completion of neoadjuvant treatment but prior to surgery. Some patients will be invited for an interview after their surgery as part of the evaluation. A subset of patients/surgeons will also have their surgical consultation audio-recorded. Read Less

This NIH project will examine the effects of routine flavonoid-rich blueberry intake (12-weeks), combined with or in the absence of regular moderate exercise, on cognitive function in a clinical population of older participants identified as experiencing age-related cognitive changes. This project's hypothesis is that the combination of flavonoid-rich diet and routine physical activity may potentiate cognitive benefits and reduce cognitive decline in an aging population, via mechanisms mediated by the gut microbiome. Read Less

This study involves the collection of blood samples and measurement with the T-TAS PL assay to compare the performance of the T-TAS wS instrument to the T-TAS 01 instrument Read Less

Approximately 1 out of every 3 adults experiencing homelessness has a current alcohol use disorder (AUD). Alcohol use plays a central role in increased morbidity and mortality in this population, with some studies suggesting it plays a direct role in as many as 17% of deaths. Alcohol is also a leading cause of homelessness and contributes to its chronicity by inhibiting progress toward obtaining employment and a stable living environment. Shelter-based treatments are common, but compliance is often poor. There are many documented challenges to effectively implementing traditional evidence-based interventions in shelter settings. In the current project, we will conduct a randomized controlled trial. Adults currently experiencing homelessness who report hazardous alcohol use (N = 600) will be recruited from five shelters across the Dallas, TX and Oklahoma City, OK metropolitan areas. Individuals will attend screening and training visits, then complete one week of self-monitoring (via smartphone app) before being randomized to receive either standard shelter-based treatment (Usual Care; UC), or the Smart-T Alcohol intervention + UC. The Smart-T Alcohol intervention offers on-demand content and automated contextually tailored messages to reduce alcohol consumption. The intervention period will span eight-weeks (i.e., weeks 2-9), with follow-up assessments occurring at weeks 9, 13, and 26. All participants will complete brief daily smartphone-based surveys for 13 weeks. Aims of the project will be to assess the effects of the Smart-T Alcohol intervention on alcohol use and alcohol-related problems (Aim 1), intervention effects on key drinking risk indicators and their mediation of use outcomes (Aim 2), and identify specific subpopulations (e.g., women, racial/ethnic minorities, younger adults; Exploratory Aim 3) for which the intervention is most effective. Findings will provide a rigorous evaluation of the efficacy of the Smart-T Alcohol intervention and guide future smartphone-based interventions for this population. Read Less

Genomic research has shown that a portion of leiomyosarcomas can be attributed to an underlying cancer predisposition syndrome. However, the optimal approach for incorporating germline testing into the care of these patients. This study is assessing the beliefs about the heritability of leiomyosarcoma and other cancer risks, and attitudes towards germline testing among leiomyosarcoma patients. Read Less

The purpose of this study is to assess the safety, tolerability, and immunogenicity of mRNA-4157 alone and in combination in participants with solid tumors. Read Less

African American (AA) adults have a greater prevalence of developing cardiovascular and renal disease (CVRD) than White (W) adults. Elevated sympathetic nervous system activity is associated with increased incidence of CVRD. Physical exertion, such as exercise, acutely increases sympathetic nervous system activity directed towards the kidneys, resulting in renal vasoconstriction and reduced renal blood flow (RBF). However, the acute renal vasoconstrictor response to any sympathetic nervous system activation has not been investigated to date in AA adults. During sympathetic nervous system activation such as exercise, sympathetic outflow to the kidneys in AA adults might be exaggerated, contributing to greater renal vasoconstriction and a larger reduction in RBF. Over time, this exaggerated neurovascular response to sympathetic activation could have a negative cumulative effect on the kidneys, which could be a contributing factor to the greater incidence of CVRD in this population. Therefore, this study aims to examine the renal vasoconstrictor response to sympathetic stressors in healthy AA adults prior to development of CVRD to test the hypotheses that the renal vasoconstrictor response to acute dynamic exercise, as well as a cold pressor and mental stress tests, is exaggerated in healthy young AA compared to W adults. To test these hypotheses, the investigators will measure RBF and blood pressure at rest and during cycling exercise and a cold pressor and mental stress tests to calculate renal vascular resistance responses to these acute interventions. Using the highly innovative approach of Doppler ultrasound to measure RBF during exercise and non-exercise sympathetic stressors non-invasively and with high temporal resolution will enable us to assess the renal vasoconstrictor response to sympathetic stressors in healthy AA adults prior to development of CVRD, so the underlying integrative physiological responses to sympathetic activation in AA adults can be understood. Findings from this study in this understudied yet clinically significant area will contribute to the ultimate goal of creating and implementing treatment strategies to reduce the risk of developing CVRD in AA adults. Read Less

This study will evaluate the safety and efficacy of intravesical administration of EG-70 in the bladder and its effect on bladder tumors in patients with NMIBC. This study study consists of two phases; a Phase 1 dose-escalation to establish safety and recommended the phase 2 dose, followed by a Phase 2 study to establish how effective the treatment is. The Study will include patients with NMIBC with Cis for whom BCG therapy is unresponsive and patients with NMIBC with Cis who are BCG-naïve or inadequately treated. Read Less

To characterize the safety and tolerability of nivolumab injected intralesionally in patients with high-risk oral premalignant lesions. Read Less

Background: People who have a blood stem cell transplant can sometimes develop cytopenia. This means that their levels of one or more types of blood cell, such as the red cells or platelets, are lower than they should be. This can occur because a person s immune system might attack these cells after a stem cell transplant. Cytopenia can lead to anemia, severe bleeding, infections, and other problems. Treatments are needed to help keep blood cell levels stable after blood stem cell transplant. Objective: To test a study drug (fostamatinib) in people who have cytopenia after a blood stem cell transplant. Eligibility: People aged 18 to 75 years who have cytopenia after a blood stem cell transplant. Design: Participants will be screened. They will have a physical exam. They will have blood, urine, and stool tests. Fostamatinib is an oral tablet taken by mouth. Participants will take the pills 2 times a day for 12 weeks. Participants will have a medical assessment every 2 weeks; their vital signs will be checked, and they will have blood and stool tests. Participants must come to the NIH clinic for these visits in weeks 4 and 12. Other visits may be done by telephone or telehealth; the blood and stool tests can be sent to the researchers from a local lab. After 4 weeks, some participants may begin taking a higher dose of the drug. Participants will return for a final medical assessment 2 weeks after they finish taking the drug. Participants who complete this study and show evidence that fostamatinib has increased their blood cell counts may enroll in an extension study to continue taking fostamatinib. Read Less

This is a 24-month, observational study of 100 participants with Limb Girdle Muscular Dystrophy type R1, also known as CAPN3. Read Less

The proposed research, which will systematically and comprehensively characterize the withdrawal among daily vapers compared to daily smokers of combustible cigarettes, filling critical gaps in the understanding of electronic nicotine delivery systems (ENDS) dependence/abuse liability and contributing to the development of therapies for tobacco/nicotine use, the leading preventable cause of death in the US. Read Less