Office of Research
Clinical Trials

Leading the Future of Clinical Medicine
The College of Medicine is a hub for groundbreaking clinical research. With over 30 specialized research units, our teams are dedicated to translating laboratory discoveries into life-saving clinical applications. From neurology to oncology, we provide the infrastructure and expertise necessary to push the boundaries of modern medicine.

Browse our Research Units below to view current study listings.

Clinical Trials Search

Jennifer Leddon, MD, PhD

Jennifer Leddon, MD, PhD

Phase 1 - Solid Tumor

Phase 1

TRI611 in ALK Positive NSCLC

This is a Phase 1/2 study testing an oral drug called TRI-611 in adults with ALK-positive non-small cell lung cancer. The study has two parts. Part 1 finds the safest dose by giving increasing doses to small groups of participants. Part 2 tests how well the chosen dose works in three groups: people who had no prior ALK drugs, people who had several prior ALK drugs including lorlatinib and neladalkib, and people with intermediate prior treatment histories. Participants take TRI-611 daily as long as it helps and side effects are tolerable. They will visit the clinic about seven times in the first three months, then once at the start of each 28-day treatment cycle, and will keep a diary of doses. Main goals are to assess safety and side effects, pick a recommended dose, and measure tumor response and how long responses last. Some outcomes (like survival and duration of response) will be followed for up to about five years.

This study may be appropriate for those with: Metastatic Cancer

Jordan Kharofa, MD

Jordan Kharofa, MD

Head and Neck Cancer

Phase 1

Study of Ipatasertib with Chemoradiation for Head and Neck Cancer

This study is testing if a new drug, ipatasertib, can improve treatment when added to the usual chemotherapy and radiation for advanced head and neck cancer. Ipatasertib could help stop cancer growth by targeting specific proteins in cancer cells. The study aims to find the best dosage alongside existing treatments. It's primarily for patients with advanced stages of head and neck squamous cell carcinoma. Participants must be 18 or older, able to swallow pills, and meet certain health criteria. The study examines safety, necessary dosage, and treatment effectiveness. Patients will receive ipatasertib and typical cancer treatments over a set schedule and undergo various imaging tests. After treatment, they'll be monitored periodically up to two years. This research hopes to improve survival rates and better control cancer growth through this novel treatment combination.

This study may be appropriate for those with: Newly Diagnosed Cancer

Sara Medek, MD

Sara Medek, MD

Head and Neck Cancer

Phase 2

Study on BMX-001 for Reducing Mouth Sores in Head and Neck Cancer Patients

This research study is looking at whether a new drug, BMX-001, can help reduce mouth sores for patients receiving chemoradiation therapy for head and neck cancer. Mouth sores can be painful and make swallowing difficult. The study is for patients who are receiving standard cancer treatment with radiation and the drug cisplatin. The patients will be divided into two groups: one will receive a placebo, while the other group will get BMX-001. Both groups will follow the usual symptom management and will be monitored closely. This study aims to see if BMX-001 can effectively reduce the severity and duration of mouth sores better than usual care alone. Patients' progress will be followed even after the treatment ends, up to 24 months, to gather comprehensive results.

This study may be appropriate for those with: Metastatic Cancer

Sara Medek, MD

Sara Medek, MD

Head and Neck Cancer

Phase 3

Investigating NBTXR3 and Radiation for Head and Neck Cancer

This study is testing a treatment called NBTXR3 to see how well it works when combined with radiation therapy, compared to just using radiation therapy with or without a drug called cetuximab. The research is focused on elderly patients who have advanced head and neck squamous cell cancer but cannot undergo platinum-based chemotherapy. Participants will be randomly assigned to two groups; one will receive NBTXR3 with radiation therapy, and the other will receive radiation therapy alone or with cetuximab as chosen by their doctor. The goal is to track how long patients live without their cancer getting worse and overall survival, among other measures. The treatment happens over 7 weeks, with a series of follow-up visits planned afterward.

This study may be appropriate for those with: Metastatic Cancer

Rekha Chaudhary, MD

Rekha Chaudhary, MD

Skin Cancer & Sarcoma

Phase 2

Amivantamab Versus Cetuximab in cSCC

This study is testing a new treatment approach for people with cutaneous squamous cell skin cancer that has come back or spread and who have weakened immune systems. Participants are placed into one of two groups. One group gets amivantamab given under the skin together with hyaluronidase to help the drug stay in the body longer. The other group gets cetuximab given into a vein. Treatment is given in 28-day cycles for up to about 24 cycles unless the cancer gets worse or side effects are too severe. Doctors will check safety, how well the cancer responds, and how long people live without cancer growth. Blood tests and scans will be done throughout treatment, and some patients will be followed afterward for years. The study also collects samples for future research.

This study may be appropriate for those with: Metastatic Cancer

Brian Grawe, MD

Brian Grawe, MD

Sports

Studying Whether Tranexamic Acid Improves Visualization and Recovery in Rotator Cuff Surgery

This study is testing whether adding a small amount of tranexamic acid (TXA), a medication that helps reduce bleeding, to the irrigation fluid used during shoulder arthroscopy can improve the clarity of the surgical view and affect early recovery. When surgeons operate with a camera inside the shoulder, bleeding can cloud the view, making surgery more difficult. TXA might help reduce this bleeding. Adults who are scheduled for arthroscopic rotator cuff repair may be invited to join. After giving consent, patients are randomly assigned to one of two groups: Standard saline irrigation, or Saline irrigation with a low dose of TXA mixed in. Neither the patient nor the surgeon will know which one is used to keep the study fair. The surgery is performed using the usual minimally invasive technique. The video from the procedure is recorded so that surgeons can later rate how clear the view was at different points in the operation. After surgery, patients will have their shoulder movement checked, complete short surveys, measure pain at 8, 24, and 48 hours, and have their swelling measured. Doctors will also review the medical record for information such as operative time, bleeding, hemoglobin changes, and any complications. Patients continue routine clinic follow‑up at 6 weeks and then at 3, 6, 12, and 24 months, completing questionnaires about pain, function, and health. All visits are part of standard postoperative care; no extra visits are required. The purpose of this double‑blind study is to find out whether TXA can safely improve visualization during surgery and possibly help with pain control or reduce complications. The results may help guide future shoulder surgery practices.

Jonathan A. Bernstein, MD

Jonathan A. Bernstein, MD

Rheumatology/Allergy/Immune

Phase 2

BLU 263 ISM Treatment Study

This study tests BLU-263 (elenestinib) versus placebo in people with indolent systemic mastocytosis whose symptoms are not controlled by usual medicines. Participants continue symptom-directed therapy (like antihistamines, proton-pump inhibitors, cromolyn, or corticosteroids) while getting either BLU-263 or placebo. The trial has several parts: short-term randomized blinded parts to measure symptom change and safety at about 13 or 49 weeks, plus an open-label long-term part where participants can continue BLU-263 for up to 5 years to monitor ongoing safety and benefit. Some groups enroll people who previously took a KIT inhibitor and special pharmacokinetic groups check how the drug behaves in the body. Main measures include changes in a validated symptom score, safety events, blood tryptase and KIT D816V levels, bone marrow mast cells, quality of life, anaphylaxis rate, and bone health.

Loren Brook, MD

Loren Brook, MD

Crohn's Disease

Phase 2

Targeted Therapies Crohns Disease

This is a Phase 2, randomized study testing several targeted medicines for adults with moderate to severe Crohn's disease. About 540 people will be enrolled worldwide and will be randomly assigned to one of the available study treatments. The medicines being tested include risankizumab, trosunilimab, and ABBV-8736, given by injection under the skin or by vein infusion depending on the drug. The main goal is to see how many participants reach endoscopic remission at Week 12. Participants will have regular clinic visits, blood tests, endoscopies, safety checks, questionnaires, and a daily diary to track symptoms and side effects.

Jean Elwing, MD

Jean Elwing, MD

PAH

Phase 3

Treprostinil for PH ILD Study

This is a Phase 3 randomized, double blind, placebo controlled study testing an inhaled medicine called treprostinil palmitil inhalation powder (TPIP) in adults who have pulmonary hypertension from fibrotic interstitial lung disease. Participants will take TPIP or a matching placebo once daily for 24 weeks. The main goal is to see if TPIP improves exercise ability measured by the six minute walk test at 24 weeks. The study also looks at clinical worsening events, major illness or death, a blood marker of heart strain (NT proBNP), symptom scores, and blood drug levels. People must have their lung scarring confirmed by CT and pulmonary hypertension confirmed by right heart catheterization. Some heart, lung, clotting, smoking, allergy, or other health problems will prevent participation. Side effects may include cough, throat irritation, headache, flushing, nausea, dizziness and low blood pressure. Results will help show whether daily TPIP is an effective and safe treatment for this group of patients.

University of Cincinnati Cancer Center

Just In Time

Phase NA

Contact UCCC CTO for Study Activation

Specific study details/protocols can be provided upon request

Kara De Felice, MD

Kara De Felice, MD

Ulcerative Colitis

Phase 3

Afimkibart in Moderate Severe UC

This Phase 3 randomized study tests Afimkibart (RO7790121), an investigational antibody, versus placebo as a short induction treatment for people with moderately to severely active ulcerative colitis. The main goal is to see how many participants reach clinical remission at Week 12 and to measure healing of the colon with endoscopy and tissue tests. The study also looks at early symptom change (Week 2), pain, urgency, fatigue, quality of life, and safety up to about 30 weeks. Eligible adults must weigh at least 40 kg, be up to date on cancer screening, and have tried but not benefited from at least one standard UC therapy. People with certain infections, recent cancers, specific types of colitis, pregnancy, or prior anti‑TL1A treatment are not allowed to join.

Caroline Freiermuth, MD

Caroline Freiermuth, MD

Ultrasound | Opioid Reduction

Freiermuth ALTO

Decrease the overall morphine milliequivalents administered to patients who present with femoral fracture or shoulder dislocation by 10% through expanded utilization of ultrasound-guided local anesthetic administration. Objective 1: By the end of year 2, 50% of faculty and residents will have performed a nerve block for one of the targeted conditions or completed training utilizing models through educational sessions led by ultrasound fellowship trained faculty Objective 2: Utilize research staff to screen the ED for eligible patients and remind the treatment team of protocols for ultrasound-guided blocks to increase uptake Objective 3: By the end of the project, perform nerve blocks for at least 50% of patients seen for femur fractures or shoulder dislocations, for a total of 311 patients treated Objective 4: Quarterly assess differences in amount of morphine milliequivalents administered to patients for femur fractures and shoulder dislocations among those who received a nerve block compared to those that did not to monitor impact of the program and guide educational and informational initiatives

Robert Stanton, MD

Robert Stanton, MD

Subacute

Anticoagulation in ICH Survivors

The Anticoagulation in Intracerebral Hemorrhage Survivors for Stroke and recovery study is a randomized, double-blinded, phase III clinical trial designed to test the efficacy and safety of anticoagulation, compared with aspirin, in patients with a recent ICH and high risk non valvular AF. A total of 700 patients, age 18 or older with a first ever ICH 14-120 days before entry will be randomized in a 1:1 ratio to receive apixaban ( 5 mg tablet twice daily or 2.5 mg tablets twice daily for patients meeting standard dose adjustment requirements) or aspirin (81 mg tablet once daily).

Justin Virojanapa, DO

Justin Virojanapa, DO

Functional | Spine

Brain and spine imaging before and after neck surgery for instability

This research study is looking at how advanced MRI scans can show changes in the brainstem and upper spine in people with craniocervical instability or a condition called basilar invagination. Participants will have MRI scans before surgery and again after surgery as part of their regular care, with one additional special scan. Researchers will compare these images to see how the spine and brainstem change after treatment and whether these changes relate to symptoms and recovery. The goal is to improve how doctors measure treatment success and better understand which patients may benefit from surgery.

Kerri McGovern, MD

Kerri McGovern, MD

Head and Neck Cancer

HNSCC Longitudinal Multiomic Study

This is a non‑interventional, forward‑looking study that will collect blood and tumor tissue from adults with metastatic or unresectable recurrent head and neck squamous cell carcinoma who are starting first‑line anti‑PD‑1 or anti‑PD‑L1 therapy as part of usual care. Samples will be tested using next‑generation sequencing (NGS), circulating tumor DNA (ctDNA) assays, RNA and immune profiling, and other multiomic techniques. Collections occur at baseline and at multiple time points during treatment and follow up. The goal is to find biomarkers that help predict who will benefit from treatment, understand how cancers become resistant, and link biomarker changes to real‑world outcomes like survival and time to next treatment. Participants are followed for up to five years; no experimental treatments are provided as part of the study.

This study may be appropriate for those with: Metastatic Cancer

Melissa DelBello, MD

Melissa DelBello, MD

Bipolar

Phase 3

Lumateperone Pediatric Bipolar Study

This is a phase 3, multicenter, randomized, double-blind, placebo-controlled study testing lumateperone in children and adolescents aged 10-17 who have bipolar I or II disorder and are currently in a major depressive episode without psychosis. After a screening period (up to 2 weeks) to confirm eligibility, participants are randomly assigned 1:1 to receive either lumateperone or placebo for 6 weeks while neither participants nor study staff know which treatment is given. About one week after the last dose, patients return for a safety follow-up visit. The main goal is to see if lumateperone improves depressive symptoms at week 6 (measured by a standard depression rating scale) and to monitor safety. Key eligibility points include a confirmed bipolar diagnosis, a recent depressive episode of at least 4 weeks, a history of at least one manic or hypomanic episode, and no high suicide risk or recent manic hospitalization.

Greg R. Dion, MD

Greg R. Dion, MD

Laryngology

Studying Airway Cells in the Lab

Adults having airway surgery may allow small cell samples to be collected and grown in the lab. This research helps scientists study airway diseases and test new treatments but does not change patient care.

Kerri McGovern, MD

Kerri McGovern, MD

Head and Neck Cancer

Phase 3

Amivantamab added to carboplatin and pembrolizumab vs standard platinum regimens in treatment‑naive R/M HNSCC

This study is to see how well a treatment that includes amivantamab, pembrolizumab and carboplatin works compared to a different treatment that includes 5-FU, pembrolizumab and platinum (carboplatin or cisplatin) therapy. 5-FU, pembrolizumab and platinum (carboplatin or cisplatin) are already used together to treat recurrent/metastatic head and neck squamous cell carcinoma.

This study may be appropriate for those with: Metastatic Cancer

Toan T. Le, MD

Toan T. Le, MD

Joints

Phase 2

Cyclic Irrigation Expanded Access

This expanded access program offers the VT-X7 system, which delivers vancomycin and tobramycin by cyclic irrigation, to people having exchange surgery to treat a prosthetic joint infection (PJI) of the hip or knee who lack other treatment options. Eligible people are adults 22 to 84 years old who are scheduled for implant removal and who have a confirmed PJI. The program is for patients who may have failed prior exchange surgery. Certain people are not allowed to join, including those with recent bloodstream infection, infection in more than one joint, severe kidney disease, pregnancy, known allergies to the study antibiotics or certain implant materials, active cancer chemotherapy, high dose steroids, some immune problems, recent substance abuse, or other issues that would make study participation unsafe. Treatment involves the surgical removal of the prosthesis and use of the VT-X7 irrigation system during the exchange procedure, with hospital care and follow-up as directed by the study site. The aim is to give access to this antibiotic irrigation approach and to observe how well it is tolerated and works for these patients.

Elizabeth A. Kelly, MD

Elizabeth A. Kelly, MD

General

Understanding Social Factors and Infant Health Outcomes

This research study is trying to better understand how social factors like housing, income, transportation, and access to health care may affect infant health. The study includes people who give birth at University Hospital. Participants are asked to complete a survey after delivery. The information collected will be used to learn why some communities have higher rates of premature birth or infant death and to help guide future programs to improve infant health. There is no cost or risk to take part, and participation helps improve understanding of infant health in the community.

Rodrigo Patino, MD

Rodrigo Patino, MD

Depression

Mobile Intervention for Teen Suicide

This study is a double-blind, randomized pilot trial testing two smartphone-based digital programs to lower suicidal thoughts in teens. About 114 adolescents (ages 13-17) who were recently hospitalized after a suicide attempt or who have suicidal thoughts with a past attempt will join with a parent or guardian. Teens and parents, and the research staff who assess them, will not know which digital program the teen receives. The main goal is to see if suicidal thoughts improve over 12 weeks using a standard suicide ideation scale. Teens must have a smartphone and agree to allow one year of medical record review to track any suicide attempts after enrollment. The study screens out teens who are acutely intoxicated, in other similar trials, unable to follow procedures, have serious medical/psychiatric issues that make participation unsafe, or who will be transferred to another inpatient bed at discharge.

Alberto Espay, MD

Alberto Espay, MD

Multiple Sclerosis

Understanding genetic Parkinson's disease

This study looks at people with a rare genetic form of Parkinson's disease and their family members. Researchers collect samples like blood, spinal fluid, and skin to better understand how the disease develops. The goal is to improve understanding of Parkinson's disease causes.

Caleb M. Adler, MD

Caleb M. Adler, MD

Bipolar | Depression

Phase 2

Icalcaprant in Bipolar Depression

This research tests an experimental pill called icalcaprant to treat depressive episodes in adults with bipolar I or II disorder. About 195 adults will be randomly assigned to one of three groups and will take either icalcaprant or a matching placebo once a day for 6 weeks. Neither participants nor staff will know who gets the real drug. After treatment, participants will have a 4-week safety follow-up. The study checks whether depression symptoms improve and records any side effects through medical assessments, blood tests, and questionnaires. Visits occur at study clinics and the number and schedule of visits depend on study procedures at each site.

Abhimanyu Mahajan, MD, MHS, FAAN

Abhimanyu Mahajan, MD, MHS, FAAN

Parkinson's disease | Movement Disorders

Hypotension in PDD and DLB

Is hypotension the mechanism behind cognitive fluctuations in Parkinson's disease dementia and dementia with Lewy Bodies? The aim of the study is tp determine if the cortical electroencephalographic signatures of cognitive fluctuations are present in PDD and DLB patients with OH. We will use a tilt table test to determine if PDD/DLB patients with OH may have a differential electroencephalographic pattern than those without OH. Hypothesis: PDD and DLB patients with OH will have dominant frequency variability between alpha (8.0-12.0 Hz) and pre-alpha (5.5-7.5 Hz) bands compared with patients without OH.

Kerri McGovern, MD

Kerri McGovern, MD

Lung Cancer

Phase 3

Testing a New Combination Therapy for Advanced Lung Cancer

This study is looking at a new treatment combination for people with advanced lung cancer who have stopped responding to typical immune checkpoint inhibitors. The new combination includes the drugs N-803, tislelizumab, and docetaxel vs. just docetaxel alone, to see which is more effective in extending patients' lives. Adults 18 or older with this specific type of cancer could participate if they meet certain health requirements. Key aspects include the ability to follow the study procedures, managing contraception requirements, and having a specific level of health for various bodily functions. Some individuals will not qualify if they have recent treatments that conflict with the new drugs, have severe allergies to study drugs, or other significant health concerns.

This study may be appropriate for those with: Metastatic Cancer

Ahmad R. Sedaghat, MD

Ahmad R. Sedaghat, MD

Rhinology

Understanding chronic sinus and nasal inflammation

This research aims to learn more about conditions that cause long-lasting sinus and nasal inflammation, such as chronic sinusitis and allergies. People already receiving routine care may be asked to provide small samples of nasal mucus, blood, or tissue during regular clinic visits. Researchers will compare these samples with symptoms and treatment results over time to understand why some patients respond better to medical treatments than others. The goal is to support more personalized care in the future.

Kyle Wang, MD

Kyle Wang, MD

Radiation Oncology

Heart Health Screening During Cancer Care

The study looks at CT scans already done for radiation planning to see if there are signs of heart disease. Adults receiving curative radiation may join. Participation involves surveys and sharing scan findings with doctors. This may help find heart disease earlier.

Jennifer Leddon, MD, PhD

Jennifer Leddon, MD, PhD

Lung Cancer

Phase 3

Study of Rilvegostomig vs. Pembrolizumab with Chemotherapy for Lung Cancer

This study is testing two treatments for people with a specific type of lung cancer called metastatic squamous non-small cell lung cancer (NSCLC). It's for patients whose tumors test positive for a marker called PD-L1. The main goal is to see if a new drug, rilvegostomig, combined with chemotherapy, helps people live longer or stop their cancer from progressing more than the standard treatment, pembrolizumab, combined with chemotherapy. Patients will be randomly placed into either treatment group and both will be blind to which they are receiving to ensure fair results. The study will check how well the treatments work over approximately five years, looking specifically at survival rates and the control over cancer growth and spread. Safety and side effects are also being monitored.

This study may be appropriate for those with: Metastatic Cancer

Ian Paquette, MD

Ian Paquette, MD

Gastrointestinal Cancer

Neoadjuvant Chemotherapy, Excision And Observation vs Chemoradiotherapy For Rectal Cancer

This study aims to determine whether rectal cancer's response to treatment is the same when patients receive chemotherapy alone before limited surgery versus when they receive both chemotherapy and radiation therapy before limited surgery, and if omitting radiation therapy improves quality of life.

This study may be appropriate for those with: Newly Diagnosed Cancer

Brittany N. Krekeler, PHD,CCC-SLP

Brittany N. Krekeler, PHD,CCC-SLP

Dysphagia Rehab

Understanding Swallowing Exercises

Healthy adults complete swallowing and tongue exercises during a single x-ray swallow study visit. The goal is to understand how these exercises move swallowing muscles.

Brian Grawe, MD

Brian Grawe, MD

Sports

Comparing Two Biceps Tenodesis Techniques to Understand Recovery and Shoulder Function

This study compares two common ways of performing biceps tenodesis, a surgery used to treat shoulder pain caused by problems with the biceps tendon. One method, done by Dr. Grawe, uses an arthroscope and repairs the tendon above the pectoral muscle (arthroscopic supra‑pectoral). The other method, used by Dr. Utz, Dr. Summers, and Dr. Branam, uses an open incision below the muscle (open sub‑pectoral). Both are standard procedures used widely in shoulder surgery. Adults who are advised to undergo biceps tenodesis may be invited to participate. After agreeing to join the study, patients will complete short questionnaires about shoulder function and general health, and their shoulder motion will be measured. The type of surgery they receive will be based on the surgeon performing the procedure-not by randomization. After surgery, participants return for follow‑up visits at 6 weeks and at 3, 6, 12, and 24 months. At these visits, doctors check healing, shoulder movement, and symptoms. Patients also complete questionnaires to track pain and shoulder function. A routine ultrasound at the 3‑month visit helps evaluate how the tendon is healing. The study also includes a scar assessment to understand patient satisfaction with the appearance of their incision. The purpose of the study is to learn whether one surgical technique leads to better recovery, improved strength, less pain, or better cosmetic results. Both surgeries are standard treatments and pose no additional risks or costs beyond normal care. The information learned will help guide future patients and surgeons in choosing the most effective approach for biceps tendon problems.

Zulfa Omer, MD

Zulfa Omer, MD

Other

Comparing Effectiveness of Rituximab or Mosunetuzumab in Patients With Nodular Lymphocyte-Predominant Hodgkin Lymphoma

This phase II study evaluates the effectiveness of mosunetuzumab versus rituximab, the standard treatment, in extending survival for patients with nodular lymphocyte-predominant Hodgkin lymphoma (NLPHL). Both mosunetuzumab and rituximab are monoclonal antibodies targeting the CD20 protein on B cells and certain cancer cells, potentially enhancing the immune system's ability to destroy cancer cells. The trial aims to determine if mosunetuzumab offers a superior survival benefit compared to rituximab for individuals with NLPHL.

This study may be appropriate for those with: Relapsed / Refractory Cancer

Hani Kushlaf, MD

Hani Kushlaf, MD

Neuromuscular

Phase 3

Empasiprubart versus IVIg in CIDP

This Phase 3 study compares an investigational drug called empasiprubart with standard intravenous immunoglobulin (IVIg) in adults who have CIDP and who have previously responded to IVIg. In Part A (24 weeks) participants are randomly assigned in a double blind way to receive either empasiprubart plus a placebo that looks like IVIg or IVIg plus a placebo that looks like empasiprubart. After finishing Part A, all participants may enter Part B and receive empasiprubart for up to 96 weeks. The main goal is to see whether patients improve by at least one point on a disability scale (aINCAT) at week 24. The study also tracks strength, grip, walking time, patient reported quality of life and fatigue, work impact, antibody responses to the study drug, drug levels in the blood, and any side effects over the full study period.

Emily Hill, MD

Emily Hill, MD

Parkinson's disease

PD GENEration Genetic Registry

This study collects genetic test results and leftover DNA from people with Parkinson's to build a central, secure resource for future research. Adults who have a probable Parkinson's diagnosis and agree to genetic testing can join. Participants allow their data to be stored for research and can choose to be told their results for several PD-related genes. The study also provides genetic counseling so people can understand what their results mean. It is an observational, one-time study (cross-sectional) meant to find how common certain gene changes are and to help researchers studying Parkinson's. There is no drug or treatment given; the study involves surveys, genetic testing, and storing DNA for future studies.

Lauren E. Menzies, MD

Lauren E. Menzies, MD

Subacute

Phase 3

Cilostazol Prevent Recurrent Stroke

This is a phase 3, randomized trial testing whether adding the medicine cilostazol to a person's current antiplatelet drug (either aspirin or clopidogrel) helps prevent another stroke, heart attack, or death from blood vessel disease. People who had a stroke or mini‑stroke (TIA) in the past 180 days and who are taking one antiplatelet drug may join. Participants will be followed for up to 4 years to see how long it takes for major events (stroke, heart attack, or vascular death) to occur. The study will also track time to ischemic stroke and the time to any major bleeding events. People with a recent spontaneous brain bleed, significant heart failure, or a life expectancy under 6 months are not eligible. The trial is not yet recruiting.

Alberto Espay, MD

Alberto Espay, MD

Parkinson's disease | Movement Disorders

TQR-84 (Placebo Study)

Patients will be told they are receiving either a novel medication (TQR-84) or placebo. However, all participants will receive IR-CD/LD. We will evaluate the differences on motor improvement after levodopa introduction, as measured by the motor subscale of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS-III),13 between a positive framework (to enhance expectations) compared to a neutral framework (to dampen expectations).

Kara B. Markham, MD

Kara B. Markham, MD

Maternal & Fetal Medicine

Phase 3

Evaluating Nipocalimab for Reducing Risk of Severe HDFN in Pregnancies

This study aims to determine the effectiveness of a drug called nipocalimab in pregnant women who are at risk for severe Hemolytic Disease of the Fetus and Newborn (HDFN), a condition where the mother's antibodies attack the baby's red blood cells, leading to anemia in the baby. Anemia can cause serious problems for unborn babies, including death. The study compares nipocalimab to a placebo to see if it can safely reduce these risks and improve outcomes like preventing fetal loss or life-threatening conditions. Participants will be randomly assigned to receive either the drug or a placebo and will be monitored throughout their pregnancies and after their babies are born until they are at least 24 weeks old.

Jennifer Leddon, MD, PhD

Jennifer Leddon, MD, PhD

Phase 1 - Solid Tumor

Phase 1

Dose Escalation/​Expansion Trial to Evaluate the Safety and Anti-tumor Activity of TEV-56278 alone or with Pembrolizumab

This clinical trial is assessing a new treatment, called TEV-56278, which is being tested alone and in combination with another drug called Pembrolizumab. This trial focuses on individuals who have advanced solid tumors. These types of tumors might be resistant to standard treatments or have not responded well to them. This study, conducted by Teva Branded Pharmaceutical Products, aims to find a safe and effective dosage of TEV-56278. It hopes to determine whether it can effectively inhibit tumor growth when used on its own or together with Pembrolizumab. Participants will be observed for any side effects and to see how well the tumor responds to the treatment. The study duration includes being treated for up to one year and followed for up to another year, totaling a possible two years per participant. The trial is ongoing, offering treatment possibilities for those who meet specific inclusion criteria, including having previously received treatment for their tumor and having a life expectancy of at least 12 weeks.

This study may be appropriate for those with: Metastatic Cancer

Liran Oren, PHD

Liran Oren, PHD

How Straw Exercises Affect the Voice

Healthy adult singers will try different straw-based voice warm-ups. Researchers will measure how the voice responds to different straw types. There is no medical benefit, but the study may inform voice training.

Aram Zabeti, MD

Aram Zabeti, MD

Multiple Sclerosis

Phase 3

Studying a Switch in Treatment for Relapsing Multiple Sclerosis

This study is testing whether a daily oral medicine called remibrutinib works as well as the current treatment, ocrelizumab, for people with relapsing multiple sclerosis. People who have been on ocrelizumab for at least 18 months and are between 40 and 70 years old may join. The study will look at how MS changes over time using MRI scans, physical tests, and symptom reports. Participants may receive remibrutinib or continue ocrelizumab for up to two years, and those who finish this part may continue on remibrutinib for another two years. The study aims to learn whether switching to remibrutinib is safe, effective, and easier for patients.

Katie M. Phillips, MD

Katie M. Phillips, MD

Rhinology

Understanding Flare-Ups in Chronic Sinusitis

This study aims to understand why people with chronic sinus problems sometimes experience sudden flare-ups. Adults with chronic sinusitis will have nasal samples taken during a flare-up and again about a month later. The study does not change medical care but may help improve future treatments.

Caroline Freiermuth, MD

Caroline Freiermuth, MD

Opioid Reduction

ALTO ED Integrative Health Referrals

This study tests whether routinely offering ED patients a referral to integrative health services increases use of nonpharmacologic options and reduces opioid prescribing and opioid consumption. Qualifying ED patients (age ≥18) presenting with low back pain, headache, abdominal pain, certain mental health conditions, or suspected substance use disorder will be offered a referral to the Osher Center for Integrative Health. Services available include acupuncture, mindfulness therapy, music therapy, massage, movement therapies (tai chi, yoga), lifestyle coaching, and nutrition education. The intervention is operationalized by adding the Osher Center referral to the ED preference list in the electronic health record to make it easy for ED clinicians to offer and place referrals. Participants will complete a baseline visit in the ED and a 30-day follow-up phone call to capture referral uptake, opioid prescriptions written, opioid use, pain and symptom measures, and patient experience. Patients who are pregnant, prisoners, unable to consent, actively suicidal/on psychiatric hold, febrile, trauma activations, or with altered mental status are excluded. Total participation time is 30 days (baseline plus one follow-up). The primary goals are to increase integrative health referrals and uptake and to decrease opioid prescribing and patient-reported opioid consumption after ED discharge.

Melissa DelBello, MD

Melissa DelBello, MD

Schizophrenia

Phase 3

KarXT for Teen Schizophrenia

This is a randomized, double-blind, placebo-controlled Phase 3 study testing KarXT in adolescents (13–17 years) with schizophrenia. After screening and confirmation of diagnosis, participants are randomly assigned to receive KarXT or placebo. The main goal is to see if KarXT reduces psychotic symptoms compared with placebo after about five weeks of treatment. Safety and overall clinical improvement will also be measured. The study checks symptom scales and global functioning during the treatment period. People with other major psychiatric disorders, significant medical or neurological conditions, known intellectual disability, severe liver problems, or very high blood pressure are not eligible.

Kerri McGovern, MD

Kerri McGovern, MD

Head and Neck Cancer

Phase 3

Radiation With Cetuximab or Chemotherapy

This phase 3 trial compares two treatments given with high-precision radiation therapy (IMRT) for people with advanced head and neck cancer who cannot take cisplatin. Patients are randomly placed into one of two groups. One group gets weekly cetuximab (a drug that targets the EGFR protein on some cancer cells) together with 35 daily radiation treatments over about 7 weeks. The other group gets weekly carboplatin and paclitaxel chemotherapy together with the same radiation schedule. Patients have scans and blood tests during the study and are followed after treatment at 30 days, then at 4, 6, 12, 18, 24, 30, and 36 months and then yearly. The main goal is to compare progression-free survival between the two groups. Secondary goals include comparing overall survival, side effects, where the cancer returns if it does, and changes in eating and speaking function.

This study may be appropriate for those with: Metastatic Cancer

Jeffrey R Strawn, MD

Jeffrey R Strawn, MD

Anxiety/PTSD

Phase 4

Treatment for adults with anxiety

The purpose of this study is to look at two medications, escitalopram and duloxetine, in adults with anxiety (between the ages of 18 and 50) in addition to, two add on medications, clonazepam or pregabalin. The study doctors are trying to understand which medication(s) will work best

Emily Curran, MD

Emily Curran, MD

AML/ALL

Phase 3

Beat AML Biomarker Treatment Trial

This study is a master protocol that screens people with acute myeloid leukemia (AML) using rapid lab and genomic testing. Based on the test results, each person is placed into one of several smaller treatment studies that test targeted, investigational therapies or drug combinations. The goal is to complete testing and assign patients to a matched treatment within 7 days, and then follow treatment responses and safety over time. The trial includes groups for newly diagnosed patients, relapsed or refractory patients, and a marker-negative group for those who don't match a specific marker. Some sub-studies focus on older adults or patients who cannot or choose not to get intensive chemotherapy. Follow-up can continue for years to track responses and changes in disease over time.

This study may be appropriate for those with: Newly Diagnosed Cancer

Aram Zabeti, MD

Aram Zabeti, MD

Neuro-Immunology

INEBILIZUMAB IN ANTI-NMDA ENCEPHALITIS

There are currently no medicinal products approved for the treatment of anti-N-methyl-D-aspartate receptor (NMDAR) encephalitis, a rare disease. NMDAR encephalitis is a life-threatening, antibody-mediated autoimmune disorder of the central nervous system. Standard of care includes high-dose corticosteroids AND either intravenous immunoglobulin (IVIg) OR plasmapheresis. However, as many as 47% of patients may fail to respond to initial treatment at 4 weeks; thus, there is a high unmet medical need for more effective therapies. The pathogenesis of NMDAR encephalitis suggests that B cell depletion may be an effective avenue for therapeutic intervention. The anti-CD19 B cell-depleting activity of inebilizumab suggests that it may provide benefit as treatment for NMDAR encephalitis. This study aims to define the efficacy and safety of inebilizumab in reducing the level of disability in patients with NMDAR encephalitis as measured by modified Rankin score (mRS). If you think that you might have a potential participant contact the ExTINGUISH hotline 844-4BRAIN5 (844-427-2465)

Greg R. Dion, MD

Greg R. Dion, MD

Laryngology

Studying Airway Bacteria in Stenosis

Adults undergoing airway surgery will have airway samples collected to study bacteria that may affect healing and disease.

Brittany N. Krekeler, PHD,CCC-SLP

Brittany N. Krekeler, PHD,CCC-SLP

Dysphagia Rehab

Videofluoroscopic Swallowing Norms

This study will use videofluoroscopy (a moving X-ray of swallowing) to measure how people of different ages swallow. The team will test about 280 healthy adults across the adult age span and will also collect data from three clinical groups at risk for swallowing problems: people with Parkinson disease, people with COPD, and people recently having had a stroke. The goal is to build clear normal ranges for swallowing measures (like airway protection, residue left after swallowing, timing of airway closure, and how well the throat squeezes) and to find practical cutoff points that help tell normal from disordered swallowing. The results aim to help clinicians interpret swallowing tests more reliably and guide diagnosis and treatment decisions.