All Clinical Trials

This participatory, pragmatic efficacy-implementation trial evaluates the impact of Promoting Community Conversations About Research to End Suicide (PC CARES) to evaluate Learning Circle (LC) participant outcomes (AIM#1), community-wide diffusion effects, and efficacy by tracking youth impact (AIM#2), while finding sustainable ways to scale PC CARES to other Alaska Native (AN) communities (AIM#3). Read Less

Allogeneic transplant is potentially curative for hematological malignancies but its use is limited by the development of GVHD. Ruxolitinib now has FDA approval for treatment of chronic GVHD that has failed 1-2 prior lines of therapy based on a prior large, randomized phase III study. Given this evidence of safety and efficacy in the early refractory setting (after prednisone failure), Ruxolitinib represents an ideal agent to test in the primary therapy setting. Here investigators propose a phase 2 randomized study to compare Ruxolitinib to prednisone as a first-line therapy in the treatment of chronic GVHD. Read Less

The goal of this clinical trial is to learn about the effect of breast-pumping frequency on breast milk supply/ volume in mothers of preterm infants. The main question it aims to answer is: - What effect does pumping frequency have on breast milk supply. Researchers will compare breastmilk supply of mothers who pump every 2 hours to the supply of those who pump every 3 hours to see if there is a difference in the amount of breastmilk they produce. Participants will be assigned to either pump every 2 hours or every 3 hours and record how many milliliters of breastmilk they produce daily for the first 28 days of their baby's life. Read Less

Assessing cognitive functions among individuals with severe intellectual and developmental disabilities (IDD), including RTT, is often challenging due to floor effects of many standardized assessment batteries in this population. In addition, deficits in motor function and verbal ability may obscure certain abilities in this population when using standard IQ measures. Remote eye-tracking tasks have been proposed as an alternative approach for assessing cognitive functions among individuals with severe IDD, because eye-tracking tasks can be designed to minimize the influence of gross motor and receptive language deficits on performance. Although several types of eye-tracking tasks have been evaluated in RTT, most have been implemented only at a single time-point. As a result, it is unclear whether these measures are stable over time, or sensitive to developmental changes or alterations to health status that occur in RTT (e.g., developmental regression, development of seizures, change in medication, etc.). With the recent FDA approval of trofinetide for the treatment of RTT, we have a novel opportunity to test the sensitivity of eye-tracking and other psychophysiological measures to treatment changes. Anecdotally, parents and clinicians have reported improvements in attention and alertness during trofinetide treatment, but currently available outcome measures do not capture these types of effects. Therefore, we propose to conduct a pilot trial of changes in measures of attention, oculomotor function, learning, and autonomic function, all collected using non-invasive measures, during trofinetide treatment. This is an observational within-subject design with a 4-week post-treatment assessment compared to two pre-treatment assessments. Additional optional follow-up assessments will be performed with families who are interested and returning for standard-of-care visits to Gillette or who are willing to travel for a research-only visit. Read Less

This is a prospective single center phase IIa open label nonrandomized study, which aims to test the hypothesis that the duration of castration sensitive phase of stage IV prostate cancer can be prolonged with adaptive androgen deprivation therapy (ADT) and Docetaxel. Read Less

The goal of this clinical trial is to extend this period of optimal cognitive performance by applying neurostimulation to buffer health volunteers against the effects of increased levels of stress, distraction, and cybersickness. The main questions it aims to answer are: * Can we use OpenBCI's head-mounted Galea biosensor + eXtended Reality (XR) platform to measure participants' cognitive state in relation to stress, attention and cybersickness? * How does applying external neurostimulation via Spark Biomedical's Sparrow Link transcutaneous auricular neurostimulation (tAN) system enhance cognitive performance with a closed-loop interface that automatically applies neurostimulation as a function of physiologically determined stress, attention, and cybersickness metrics? Researchers will compare the active neurostimulation group to the sham neurostimulation group to see if cognitive performance is improved with stimulation. Participants will complete 4 virtual reality tasks in the lab: * 2 tasks related to attention - Flanker and Gradual-onset Continual Performance Task (GradCPT) * The Multi-Attribute Task Battery (MATB) * A cybersickness task * And a baseline session before each task * Neurostimulation intervention will occur in response to cognitive states Read Less

The purpose of this research study is to find out if adding radiation prior to chemoimmunotherapy and surgery is effective for people with non-small cell lung cancer (NSCLC) who have the potential for surgery. Standard of Care Chemoimmunotherapy: For this study, standard of care chemotherapy will be used. This means this is the type of chemotherapy that is normal for your cancer. In addition to the chemotherapy, you will also receive the immunotherapy drug, nivolumab. This will be administered intravenously once every 3 weeks for up to 3 cycles (i.e. 9 weeks of total systemic therapy), prior to surgical resection assessment. This combination is made up of the chemotherapy drugs carboplatin or cisplatin along with pemetrexed, paclitaxel or gemcitabine, and the immunotherapy drug is nivolumab. The chemotherapy is used to kill cancer cells, and the immunotherapy enables your immune system to attack cancer cells. Stereotactic Body Radiation Therapy (SBRT) SBRT is when radiation is delivered at higher doses over a smaller period of time. For this study, you will receive three doses of radiation delivered every other day, for three total days. The final dose of radiation will happen within 7 days of starting chemoimmunotherapy. You will be followed for up to 100 days following your last chemoimmunotherapy dose to monitor for potential side effects. Following this you will continue with your standard follow up with your doctor. During the standard follow-up time, study staff will review your charts to see if there have been any new updates with your cancer following treatment so they can tell how this treatment affects how long patients live and whether it helps avoid recurrence of the cancer. Read Less

By conducting this study, we hope to assess if simethicone (also known as Gas Relief or GasX) has an effect on improving gas pain and bloating specifically in patients undergoing foregut procedures to include bariatric procedures (sleeve gastrectomy, Roux-en-Y gastric bypass), hiatal hernia, and gastric surgery. The purpose of this research is to gather information on the safety and effectiveness of simethicone. Simethicone (more commonly known as Gas Relief or Gas-X) relieves pressure, bloating, and fullness commonly referred to as gas. It is FDA approved. The use of this medication in this research study is consistent with labeling indications. Read Less

This study is a randomized, placebo-controlled, double-blinded, therapeutic exploratory clinical trial of branched chain amino acids (BCAAs) in the treatment of concussion. The aim of the study is to determine whether administration of high-dose BCAAs compared to placebo promotes concussion recovery. Read Less

This study will enroll women with PCOS to study the effects of first line therapy, oral contraceptive pills, and then either 12 weeks of resistant starch or 12 weeks of placebo to explore if resistant starch improves cardiometabolic parameters or impacts gut dysbiosis compared to placebo. Read Less

The goal of this randomized clinical controlled trial is examine the effects of gait training with auditory biofeedback (AudFB) on gait biomechanics, clinical measures of ankle joint health, and patient-centered outcomes. The following specific aims will achieve this objective: * Specific Aim 1: Determine if a 6-week gait training with AudFB intervention improves lower extremity biomechanics compared to a Control condition in participants with CAI. * Specific Aim 2: Determine if a 6-week gait training with AudFB reduces talar cartilage deformation compared to a Control condition in participants with CAI. * Specific Aim 3: Determine if a 6-week gait training with AudFB reduces episodes of ankle giving-way and reduces self-perceived severity of symptoms relative to a Control condition in participants with CAI. Participants will: * Complete 12 intervention sessions over a 6-week period of walking, ruck marching, and runninig. * Complete testing sessions before and after the intervention, then after 6 and 12-months following the intervention. 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