Clinical trials

The purpose of the aPCC-emicizumab safety study is to investigate the hemostatic efficacy as measured by thrombin generation, of a low personalized dose of aPCC (FEIBA) in children and adults with hemophilia A and inhibitors on emicizumab prophylaxis.

This study aims to develop imaging-based biomarkers to assess which chronic stroke participant with lower extremity disability may respond or resist high intensity interval training (HIIT). Previous research suggests that physical exercise training is safe and could help improve the walking speed of non-ambulatory stroke survivors. However, inter-individual variability in response to exercise is extraordinarily high regardless of adherence, and predictors of response remain elusive. Chronic stroke survivors with lower limb disability resulting in slow walking speeds will participate in 12 weeks of cycling exercise at Emory University under the guidance of a physical exercise instructor, 3 days a week, for 25-60 minutes. During some of the exercise sessions, the investigators will collect blood lactate with a finger prick. Brain scans with an MRI before and after the 12 weeks of exercise will be done; motor function tests that include walking, sitting down, standing up, and turning around will be collected. Participants' memory and thinking will be assessed, and participants will fill out questionnaires about their health before and after their stroke, and well as questions about their diet. The participation will last between 14-16 weeks (up to 42 study visits).

This study is being done to learn more about the role of inflammation in depressive and cognitive symptoms in patients with depression who have played at least 11 years of organized tackle football. This will be evaluated using a medication called baricitinib, which blocks one aspect of inflammation.

Patients who are being scheduled for an operative procedure with an inpatient postoperative stay are eligible for this study. Participants will be selected to start a physical fitness plan or a nutrition plan at the time of surgical scheduling. Each participant will be asked to continue their current lifestyle for two days after their pre-operative appointment to get a baseline of activity (by pedometer and functional tests) and nutritional risk (by questionnaire). After two days, patients in the activity group will start their activity plans. They will be encouraged to get 10,000 steps per day and to perform whole body strength training exercises 3 times a week. Five days before and after surgery, participants in the nutrition group will be asked to consume a standard liquid nutrition supplement (i.e. Boost or Ensure) two times per day. Participants in the activity group will record steps and number of strength training sessions completed, while patients in the nutrition group will record the number of supplements consumed.

Project SPACE is a micro-randomized trial evaluating the proximal effects theory-based text messages on alcohol use and sexual HIV risk behaviors among HIV-negative young adult men at the day-level. At baseline, all participants will complete GamePlan, an existing brief online sexual health program. During the subsequent 8-week intervention period, participants will complete a brief morning assessment of the preceding day and will be randomized each afternoon, with equal probability, to receive concrete ("how"), abstract ("why"), neutral control, or no afternoon intervention messages. Participants will also complete pre- and post-intervention measures. The effects of GamePlan are not being separately evaluated in this study.

The goal of this clinical trial is to evaluate whether a 4-week music therapy (MT) intervention can reduce chronic pain and improve psychosocial outcomes in youth with sickle cell disease (SCD). The main questions it aims to answer are: * Does MT reduce pain intensity, frequency of pain episodes, and improve health-related quality of life (HRQoL)? * Does MT alter immune cell composition and gene expression in inflammatory pathways, as measured by single-cell RNA sequencing (scRNA-seq)? Researchers will compare participants randomized to music therapy versus a control condition to see if MT produces superior improvements in pain and psychosocial outcomes, and distinct molecular changes.

The goal of this clinical trial is to learn if point-of-care tests (POCTs) for sexually transmitted infections (STIs) improve the timely treatment of syphilis, chlamydia, gonorrhea, and trichomonas in pregnant women. It will also learn about the feasibility, acceptability, and cost-effectiveness of implementing POCTs in a large safety-net hospital setting. The main questions it aims to answer are: * Do POCTs reduce delays in STI treatment compared with standard laboratory-based testing? * What barriers, facilitators, and processes affect POCT implementation in prenatal and obstetric care? * What are the costs and cost-effectiveness of POCTs compared with standard testing? Participants will: * Complete a baseline survey and receive either POCTs (fingerstick blood draw or vaginal swab) or standard laboratory STI testing. * If diagnosed with an STI, complete a follow-up survey approximately one month later. * Stakeholders (providers, hospital leadership, and public health officials) will complete interviews to inform implementation strategies.

The goal of this study is to test the maximum tolerated dose of ACU-D1 in HIV-positive people with HPV-associated vulvar and perianal lesions. The main questions it aims to answer are: * The maximum tolerated dose of ACU-D1 * Safety and tolerability of topical ACU-D1 * Whether topical ACU-D1 induces p53 and p53-mediated downstream signaling (including p21 induction) in HPV-related lesions * Whether topical ACU-D1 enhances markers of immunity in HPV-infected HIV-positive individuals Participants will be asked * To apply ACU-D1 on the lesions twice daily for 4 weeks * 3 biopsies will be performed at the screening and 3 at the end of 4 weeks.

The goal of this project is to investigate the effect of cognitive empathy training on mental health, inflammation, and immune function in caregivers of people living with dementia (PLWD), and to examine the underlying psychological and neurobiological mechanisms. The primary aim is to establish the effectiveness of cognitive empathy training in improving caregiver mental health and immune function, and in decreasing caregiver inflammation The secondary aim is to investigate the psychological and neurobiological mechanism by which cognitive empathy training improves caregiver well-being

The goal of this clinical trial is to evaluate whether an audio diary mobile application (Fabla-diabetesMM) is feasible to use and may support self-management in older adults with type 1 or 2 diabetes and multimorbidity. The main questions it aims to answer are: * Is it feasible to adapt and implement the Fabla-diabetesMM audio diary mobile app among 30 older adults with diabetes and multimorbidity * Does the use of the audio diary mobile app affect self-management outcomes

This study is being done to test whether a drug called baricitinib, which blocks specific causes of inflammation, affects HIV-1 viral rebound and viral load levels after HIV treatment is discontinued. Researchers will test the effects of continuing baricitinib in people with HIV before and after discontinuing their antiretroviral therapy. This drug is approved by the Food and Drug Administration (FDA) for other diseases; it is not approved for the treatment of HIV-1. The study team will also investigate any side effects associated with the drug.

The goal of this study is to learn whether a virtual peer recovery coach (PRC) intervention can improve engagement in addiction treatment among incarcerated adults with substance use disorders. The main questions it aims to answer are: * Does the PRC intervention increase engagement with at least one recovery resource at 30 and 90 days? * Does it improve secondary outcomes such as substance use, recovery capital, overdose events, and recidivism? Researchers will compare Treatment-as-Usual with the PRC telehealth intervention to see if PRC support improves engagement in addiction care. Participants will: * Complete baseline and follow-up assessments * Receive either Treatment-as-Usual or a virtual PRC session focused on motivational interviewing and linkage to recovery resources

This study will use procedure-specific dosimetry to evaluate whether Texray's novel woven radiation protection fabric (HeadPeace and MindPeace) reduces occupational radiation dose to the head and thyroid of interventional radiology personnel compared with standard radiation protection equipment, and to explore variation in efficacy by role, procedure type, and fluoroscopy room/equipment characteristics.

This study aims to identify electrophysiologic biomarkers associated with antidepressant response to ketamine in adults with epilepsy undergoing clinically indicated stereo-electroencephalography (sEEG) monitoring who have at least mild depressive symptoms. Participants will receive a single subanesthetic intravenous ketamine infusion (0.5 mg/kg over 40 minutes) during their Epilepsy Monitoring Unit admission. Intracranial neural recordings and behavioral assessments will be collected before and approximately 24 hours after infusion to examine changes in neural circuits associated with rumination and anhedonia.

The main purpose of this study is to compare patients with a deep bleed in the brain undergoing surgery to patients receiving routine medical care. The standard treatment involves admission to the Intensive Care Unit (ICU) with close monitoring and blood pressure control. It also includes other medical (non-surgical) treatments to prevent more bleeding or another stroke. Sometimes, doctors will recommend surgery to remove the blood if medical treatment alone is not successful. There is evidence that doing minimally invasive surgery early-using a small opening in the skull to remove blood-may help some patients. Researchers aim to understand whether this surgery is better than current medical treatment, which may include surgeries to relieve pressure on the brain in some cases. This study, called REACH, is comparing usual medical care to early minimally invasive surgery so doctors can know which is better for patients.

This clinical trial develops and studies how well mobile health (m-Health) patient navigation (PN) strategies work to improve screening and the early detection of breast cancer in women accessing primary care clinics in Kenya. Although highly curable, breast cancer kills thousands of women in developing countries yearly. Mammography (MMG) is used for the early detection of breast cancer by creating a picture of the breast using film or a computer. Despite the availability of MMG in all 47 counties in Kenya, screening remains low in eligible women. Early detection of breast cancer may also be improved through access to high quality clinical breast exams (CBE). However, primary care providers in Kenya face barriers to incorporating CBE into practice, including limited patient awareness of breast cancer screening. m-Health uses applications on mobile phones to deliver PN directly to the patients. The PN strategies in this study include digital platforms and tools to help with education, reminders, navigation, and motivation around breast cancer screening. This may improve screening and the early detection of breast cancer in women accessing primary care clinics in Kenya.

This study tests Project Using Practice and Learning to Increase Favorable Thoughts (UPLIFT) which is a Mindfulness-based Cognitive Behavioral Therapy program teaching participants with epilepsy methods that include challenging thoughts, behavioral activation, coping, problem-solving, and mindfulness, for well-being and costs. Project UPLIFT is delivered as weekly sessions over 8 weeks.

This study aims to learn whether a cognitive behavioral intervention can improve lifestyle and glucose targets for adults with type 1 diabetes.

This phase II trial tests how well atezolizumab works in treating patients with human papillomavirus (HPV) related oropharyngeal squamous cell carcinoma that is able to be removed with surgery (resectable). Immunotherapy with atezolizumab, may include changes in the body's immune system and may interfere with the ability of tumor cells to grow and spread.

The goal of this study is to learn how GLP-1 receptor agonist therapy affects muscle and bone health in older females over age 65 with type 2 diabetes. The main question it aims to answer is whether or not 6 months of GLP-1 RA therapy affects muscle strength. Participants will: * Receive GLP-1 RA therapy as part of their routine clinical care * Complete muscle strength assessments (hand grip strength, Timed Up and Go test) * Provide blood samples for bone turnover markers * Undergo bone mineral density testing

The goal of this interventional study is to Assess the safety and tolerability of atovaquone in combination with standard radiation therapy (RT) for the treatment of pediatric patients with newly diagnosed pediatric high-grade glioma/diffuse midline glioma/diffuse intrinsic pontine glioma (pHGG/DMG/DIPG). The secondary aim is to assess the safety and tolerability of longer-term atovaquone treatment for pediatric patients with relapsed or progressed pHGG/DMG/DIPG and medulloblastoma (MB) or pHGG/DMG/DIPG after completion of RT and before progression.

The goal of this study is to determine whether a multimodal sleep pathway can enhance sleep quality in hospitalized patients with orthopedic trauma. It will also evaluate the effect of this pathway on opioid use and pain perception during recovery. The main study questions are: * Does the multimodal sleep pathway improve sleep quality and duration? * Does the pathway reduce the amount of opioids patients use during hospitalization? * Does improved sleep reduce pain interference with daily activities? Researchers will compare the multimodal sleep pathway to standard postoperative care to see if the pathway helps patients sleep better and rely less on opioids. Participants will: * Receive either the multimodal sleep pathway (zolpidem, melatonin, and sleep hygiene education) or standard care * Wear a wrist-worn actigraphy device to track sleep during their hospital stay * Complete daily questionnaires about sleep quality and pain

This phase II trial tests how well enfortumab vedotin (EV) and pembrolizumab works in treating patients with bladder cancer of variant histology (a group of less common types of bladder cancer) that have spread to nearby tissue or lymph nodes (locally advanced) or that has spread from where it first started (primary site) to other places in the body (metastatic). Enfortumab vedotin is a monoclonal antibody, enfortumab, linked to an anticancer drug called vedotin. Enfortumab attaches to a protein called nectin-4 on cancer cells in a targeted way and delivers vedotin to kill them. It is a type of antibody-drug conjugate. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving enfortumab vedotin and pembrolizumab may kill more tumor cells in patients with locally advanced or metastatic bladder cancer of variant histology.

The purpose of this study is to determine whether giving extra arginine to patients with sickle cell disease seeking treatment for vaso-occlusive painful events (VOE) will decrease pain scores, decrease need for pain medications or decrease length of hospital stay or emergency department visit.

Older adults' low adherence to the national physical activity guidelines may stem from a failure to increase positive affective responses to exercise (e.g., enjoyment). Exercising with personalized, tempo-synchronous music playlists has shown promising effects on physical activity promotion in midlife-to-older adults during a cardiac rehab program. The purpose of this study is to determine how personalized, tempo-synchronous music playlists called rhythmic auditory stimulation (RAS) influence exercise behavior change and affective responses to exercise over 8 months among community-dwelling, sedentary older adults.