Ann Arbor, MI Paid Clinical Trials

Balance problems and falls are common in people with Parkinson's disease but respond poorly to dopamine stimulating medications suggesting other causes. The main goal of this study is to assess whether imbalance and gait problems in people with Parkinson's disease may be related to vestibular (inner ear balance center) changes not related to loss of dopamine in the brain. Read Less

This is a Phase 1/2, multicenter study with an open-label dose escalation followed by a randomized placebo controlled and double-blind phase of SLN124 in adult patients with Polycythemia Vera (PV) to assess the safety, tolerability, efficacy, pharmacokinetic (PK), and Pharmacodynamic (PD) response of SLN124. Read Less

This phase III trial studies how well bupropion works in reducing cancer related fatigue in cancer survivors. Bupropion is a drug that is used to treat depression, as well as to help people quit smoking. Cancer and its treatment can cause fatigue. Giving bupropion may improve cancer related fatigue in cancer survivors. Read Less

This is a first-in-human, Phase 1/2 study to evaluate LCB84, a TROP2-directed antibody-drug conjugate, alone and in combination with an anti-PD-1 Ab, in dose escalation (Phase 1) followed by dose expansion (Phase 2). The study population in dose escalation (Phase 1) consists of patients with advanced solid tumors refractory to standard of care, or for whom no standard of care exists. After the MTD and/or RP2D for single agent LCB84 is determined, dose escalation cohorts with select tumor types will be enrolled. Combination LCB84 and anti-PD-1 Ab will be evaluated in dose escalation after a minimum of 2 dose levels of single agent LCB84 have established DLT safety, to determine the MTD and/or RP2D of combination LCB84 and anti-PD-1 Ab, and to continue into dose expansion cohorts in select tumor types. Read Less

This trial studies how well paclitaxel, trastuzumab, and pertuzumab work in eliminating further chemotherapy after surgery in patients with HER2-positive stage II-IIIa breast cancer who have no cancer remaining at surgery (either in the breast or underarm lymph nodes) after pre-operative chemotherapy and HER2-targeted therapy. Drugs used in chemotherapy, such as paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Trastuzumab and pertuzumab are both a form of "targeted therapy" because they work by attaching themselves to specific molecules (receptors) on the surface of tumor cells, known as HER2 receptors. When these drugs attach to HER2 receptors, the signals that tell the cells to grow are blocked and the tumor cell may be marked for destruction by the body's immune system. Giving paclitaxel, trastuzumab, and pertuzumab may enable fewer chemotherapy drugs to be given without compromising patient outcomes compared to the usual treatment. Read Less

This open-label extension study will evaluate the long-term effects of GB002 (seralutinib) in subjects who previously participated in a GB002 PAH study. Read Less

ODYSSEY RCC is a prospective, observational Phase IV study is to understand the cancer management and health-related quality of life in patients with mRCC in routine real-world clinical practice in the United States, including both community and academic treatment settings. Read Less

BioBOOST is a multicenter, observational study of the effect of derangements in brain physiologic parameters on brain injury biomarker levels in patients with severe traumatic brain injury. Read Less

The Pediatric Dose Optimization for Seizures in Emergency Medical Services (PediDOSE) study is designed to improve how paramedics treat seizures in children on ambulances. Seizures are one of the most common reasons why people call an ambulance for a child, and paramedics typically administer midazolam to stop the seizure. One-third of children with active seizures on ambulances arrive at emergency departments still seizing. Prior research suggests that seizures on ambulances continue due to under-dosing and delayed delivery of medication. Under-dosing happens when calculation errors occur, and delayed medication delivery occurs due to the time required for dose calculation and placement of an intravenous line to give the medication. Seizures stop quickly when standardized medication doses are given as a muscular injection or a nasal spray. This research has primarily been done in adults, and evidence is needed to determine if this is effective and safe in children. PediDOSE optimizes how paramedics choose the midazolam dose by eliminating calculations and making the dose age-based. This study involves changing the seizure treatment protocols for ambulance services in 20 different cities, in a staggered and randomly-assigned manner. One aim of PediDOSE is to determine if using age to select one of four standardized doses of midazolam and giving it as a muscular injection or nasal spray is more effective than the current calculation-based method, as measured by the number of children arriving at emergency departments still seizing. The investigators believe that a standardized seizure protocol with age-based doses is more effective than current practice. Another aim of PediDOSE is to determine if a standardized seizure protocol with age-based doses is just as safe as current practice, since either ongoing seizures or receiving too much midazolam can interfere with breathing. The investigators believe that a standardized seizure protocol with age-based doses is just as safe as current practice, since the seizures may stop faster and these doses are safely used in children in other healthcare settings. If this study demonstrates that standardized, age-based midazolam dosing is equally safe and more effective in comparison to current practice, the potential impact of this study is a shift in the treatment of pediatric seizures that can be easily implemented in ambulance services across the United States and in other parts of the world. Read Less

The MyBestGI study evaluates three different approaches that could help people eat in healthier ways. The study seeks to enroll 240 overweight and obese persons who have risk factors for colorectal cancers such as a family or personal history of colorectal cancers or adenomatous polyps. The study website is www.MyBestGI.org . Participants in the study will be asked to follow one of three eating plans, as best they can, for 12 months. Study participants can choose the foods they prefer within healthy food groups. Two of the eating plans involve ten brief telephone support calls and use of a web-based app (MyBestGI App). The study primarily evaluates improvements in eating and any weight change that may result. Secondary goals for the research are to evaluate how changes in eating affect metabolic pathways. All study participants will receive written materials that encourage making room for preventive foods in your daily eating. All participants also receive the results of their own diet analyses, and results of their own measures at study visits. The measures are the Veggie Meter skin reflectance test, Ketoscan breath test, and body composition measures. Study visits also involve providing a small blood sample from the arm. Study visits are in Ann Arbor at the start of the study, and at 6 and 12 months. The long-term goal of this research is to provide better options for supporting individuals who seek to achieve and maintain a preventive style of eating. Read Less

The use of immune checkpoint inhibitors (ICIs), alone or in combination with other cancer treatments is increasing dramatically with immune-related adverse events (irAEs) common (90%) during ICI treatment. Most irAEs are symptomatic and symptom self-management with timely reporting of moderate or severe symptoms to health care providers (HCPs) may reduce irAE severity by early recognition and management, resulting in fewer treatment interruptions and unscheduled health services. Read Less

This research trial studies biomarkers in tumor tissue samples from patients with newly diagnosed neuroblastoma or ganglioneuroblastoma. Studying samples of tumor tissue from patients with cancer in the laboratory may help doctors identify and learn more about biomarkers related to cancer. Read Less