All Clinical Trials

This phase III trial evaluates whether patient care can be done remotely for patients having cranial (skull) radiation or who have previously had cranial radiation. In addition, this trial compares study outcomes between patients who get metformin and those who do not. Cranial radiation, an essential component of brain tumor treatment, can result in significant negative effects on cognitive (the ability to clearly think, learn, and remember) function. Wearable devices have been used in the field of neurology for seizure detection and assessment of patients with movement disorders. Wearable device technology has also been implemented for remote monitoring of cancer patients and for cancer clinical trials. Metformin is the active ingredient in a drug used to treat type 2 diabetes mellitus (a condition in which the body cannot control the level of sugar in the blood). It is also being studied in the treatment of cancer. Use of metformin may reduce risk of cognitive decline following radiation therapy within the skull (intracranial). These effects may be further strengthen by addition of device-based physical activity promotion. Mayo Test Drive is a web-based platform for remote self-administered cognitive assessment. Using Mayo Test Drive may help determine whether patient care can be done remotely, while simultaneously evaluating benefits of health promotion through use of a wearable watch device and metformin in preventing radiation-related cognitive decline. Read Less

The goal of this clinical trial is to investigate the effects of early initiation of double low-dose aspirin in pregnant women. The main questions it aims to answer are: Does this dose and timing of aspirin reduce the risk of pre-eclampsia compared to standard recommendations? Does this dose and timing of aspirin reduce the risk of pregnancy loss compared to standard recommendations? Participants will begin taking at no later than 6 weeks 6 days gestational age, either 162mg of aspirin through delivery or placebo until 12 weeks and then 81mg of aspirin through delivery. Read Less

To test the hypothesis that intensive cholesterol lowering (iCL) therapy has anti-tumor immune modulating activity, the investigators will conduct an open-label, single-arm phase II trial in prostate cancer patients who are in active surveillance and undergoing a planned surveillance biopsy in 3-6 months. Eligible patients will initiate iCL with Vytorin®(group 1, 2, and 3), an FDA-approved combination of ezetimibe and simvastatin used to lower atherogenic low density lipoprotein cholesterol (LDL-C) or Ezetimibe (group 4). Starting dose will be determined by current statin use and LDL-C levels. Dose modifications of VYTORIN will be employed with the goal of achieving LDL-C \<70 mg/dl. Dose adjustment is not allowed for ezetimibe. Read Less

This phase II trial tests the safety, side effects and effectiveness of mosunetuzumab in treating patients with slow growing (indolent) B-cell lymphoma. Mosunetuzumab is a monoclonal antibody that may interfere with the ability of tumor cells to grow and spread. Read Less

This study evaluates imaging methods for monitoring neural and electrical activity in the brain for improving clinical diagnosis. Read Less

Oral HIV pre-exposure prophylaxis (PrEP) is a highly effective HIV prevention modality that requires individuals to take a daily tablet to prevent themselves acquiring HIV. In South Africa while this is freely available in the public sector, persistence (that is continuation after initiation) is low amongst vulnerable populations, including men who have sex with men (MSM). This study is a feasibility and acceptability study of a behavioral economics informed intervention to improve persistence amongst MSM newly initiating PrEP in South Africa. The goal of this study is to show that this approach is possible in a routine setting and gather the necessary data for a fully powered effectiveness trial. Study participants will complete a baseline questionnaire and then be randomized to either receive standard of care (control) or to receive the intervention. The intervention package consists of evidence informed reminders, commitment pledges and planning prompts. The intervention package aims to address present bias, optimism bias and salience. The intervention is delivered and the enrollment visit and then through mobile phone reminders / text messages. There is no further in person interaction after the initial interaction. Participants may be contacted for a telephonic enplane questionnaire. Outcome data is obtained from passive followup through routine medical record review with the primary end point being persistence at 3 months. Read Less

The aim of this research study is to better understand the in-home hospice experience for participants, caregivers, hospice nurses, and oncology providers by conducting telehealth check-ins between participants and caregivers and oncology care teams. Read Less

Alaska Native children experience a high burden of respiratory disease, especially those in the Yukon-Kuskokwim (YK) Delta. Studies have shown that things like wood stove use, poor ventilation, and indoor tobacco smoke exposure can lead to poor indoor air quality inside the children's homes. This leads to more frequent and more severe respiratory infections in children. In the Yukon-Kuskokwim (YK) Delta, it's common for homes to have exposure to woodstoves and tobacco use. Both of these activities affect indoor air quality in homes. We know that high efficiency particulate air (HEPA) purifiers can reduce particulate matter and make air quality better. One way that we measure air quality is through particulate matter (PM2.5). One of the few studies that looked at this in the YK Delta found that PM2.5 levels that were nearly twice as high as homes with woodstoves in other states. We believe it is important to reduce the PM2.5 in YK Delta homes. However, the few studies that looked at HEPA purifiers in rural Alaska did not include homes where smokers lived. We know that breathing air with PM2.5 harms the lungs. We also know that HEPA filters can reduce PM2.5, which can mean reducing cough and wheeze in people with chronic lung conditions. We want to learn how HEPA filters work in homes with woodstoves or where a smoker lives, as it's likely these homes may have more PM2.5 than other homes. We expect that using HEPA filters will make the indoor air better and will mean decreased respiratory symptoms. We plan to include 15 households with a child less than 5 years old in the family. Households that join will be asked to: * Set up study equipment in their homes. * Run the study equipment for 12 weeks and do a weekly report of child's respiratory symptoms by phone or text. * Return the air-quality monitor equipment to the study team and keep the HEPA filters. Read Less

Reduce food insecurity by improving plant-based health food consumption, access, health and nutrition literacy and the health of the food-insecure families we serve. Read Less

The goal of this clinical trial is to help adolescents and young adults between the ages of 13-25 with Cystic Fibrosis (CF), medically stable, able to speak and read English, and are not experiencing a CF - related exacerbation, who are already active to remain, or gradually encourage them to increase their levels of physical activity Participants will be asked to utilize a smartphone program, called NUDGE that we have developed. NUDGE is a chatbot with evidence-based features known to help teens make progress toward health goal: * Set and review goals * Self-monitor progress * Provide feedback on goal attainment * Revise future goals Read Less

The goal of this randomized clinical trial is to test the efficacy of a fully digital intervention, combining the Lumen problem-solving therapy virtual coach for depression management with the Diabetes Prevention Program video-based program for weight loss, among racial and ethnic minorities with comorbid depression and obesity. The study aims include: * Determine the efficacy of the vCare intervention at 6 months. Primary outcomes are weight and depression symptom checklist 20-item (SCL-20) score. * Identify predictors of treatment success, defined by achieving clinically significant weight loss (5%) and depression outcomes (50% decline or SCL-20\<0.5), at 6 and 12 months. * Characterize participant experiences and perceptions of the vCare intervention. Eligible participants will be randomized to the early-intervention arm who will receive active treatment for 6 months, followed by maintenance for another 6 months, or the later-intervention arm who will be waitlisted for 6 months and then receive active treatment in the second 6 months. Read Less

The purpose of this study is to develop a brief assessment and need-based behavioral intervention for addressing aging-specific concerns in older adults with lung cancer. The long-term goals of this research include identifying the unique concerns of these patients, providing patients with behavioral skills to address their symptom management needs, and enhancing patient engagement with healthcare specialties targeting aging-specific concerns. In the first phase of this study, participants (12 patients with lung cancer, 6 caregivers, 12 providers) will be asked to participate in two individual interviews (each 30-45 minutes in length) via teleconference. During the first interview, participants will be asked to provide feedback on the current version of the assessment and behavioral intervention. Participants will be asked to describe strengths and weaknesses of the materials, topics to add or remove, and any other suggested changes. After the research team has made changes to the materials, participants will be invited to complete a second interview to provide feedback on the updated materials. In the second phase of the study, 16 older adults with lung cancer will complete the revised assessment and participate in the behavioral intervention, in order to a) evaluate the feasibility and acceptability of the program and b) measure change in depression, anxiety, pain, and dyspnea. Read Less