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

Frank McCormack, MD

Frank McCormack, MD

General Pulmonary | Ambulatory

Translational Pulmonary Science Center

Researchers are trying to learn more about diseases related to pulmonary, critical care, and sleep medicine. Much of this research is done using human tissue and health information. Through these studies, researchers hope to find new ways to detect, treat, and maybe prevent or cure health problems. Some studies may lead to new products, such as drugs or tests for diseases. A repository makes it easier for researchers to perform studies, since samples and information from many different people will be available in one place. Researchers can use samples and information only after their project is approved by a human protection review board, and samples are only dispensed after review by the Translational Pulmonary Science Center (TPSC) research committee.

513-584-1922
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.

Deepak G. Krishnan, DDS

Deepak G. Krishnan, DDS

Surgery

3D Models for Mandible Repair

This study tests whether making a 3D printed model of a patient's broken lower jaw (mandible) helps surgeons operate faster and feel more confident. Adults with an isolated mandible fracture who need surgical repair will be randomly placed into one of two groups. In the 3D model group, a patient-specific printed mandible will be used before surgery so the surgeon can plan and pre-bend the fixation plate. The control group will receive standard care without a printed model. The main things measured are total time in the operating room (especially the critical parts of the procedure) and the surgeon's satisfaction with the planning and use of the model, collected up to two days after surgery. The goal is to see if this personalized planning tool reduces OR time and is useful to surgeons when treating jaw fractures.

Learn More about 3D Models for Mandible Repair
H. Claude Sagi, MD

H. Claude Sagi, MD

Trauma

Comparing Two Surgical Approaches for Repairing Posterior Wall Hip Socket Fractures

This study looks at two ways surgeons repair a specific type of hip fracture called a posterior wall acetabular fracture. Both techniques use metal plates to support the bone as it heals. Participants are randomly assigned to one of the two standard surgical treatments and will have regular checkups with X‑rays for up to one year. The goal is to learn whether one method leads to better healing or recovery.

Michael J. Beltran, MD

Michael J. Beltran, MD

Trauma

Bead Pouch versus Wound VAC Trial

This trial will enroll 312 adults with severe open fractures of the tibia who need more than one surgical washout (irrigation and debridement). Participants are randomly assigned to one of two temporary wound treatments used between surgeries: an antibiotic cement bead pouch (beads placed in the wound and sealed with an occlusive dressing) or negative pressure wound therapy (NPWT or Wound VAC). The assigned treatment is given at the end of the first washout surgery. Patients are followed at about 6 weeks, 3 months, and 6 months. The main goal is to see which treatment leads to fewer serious problems by 6 months, using a ranked composite outcome that looks first at death, then at injury related amputation, then at unplanned reoperations for wound or healing problems, and finally at clinical fracture healing measured by a standard trauma function tool. Secondary analyses look at each of those outcomes separately. Safety and outcome events will be reviewed by independent committees.

Learn More about Bead Pouch versus Wound VAC Trial
Jed Hartings, PhD

Jed Hartings, PhD

Neurotrauma

INDICT

The goal of acute TBI treatment is to minimize secondary damage that evolves over hours to days after the primary injury. Until now, however, there have been no methods for monitoring heterogeneous pathologic mechanisms to identify patients for appropriate neuroprotection therapies. Using invasive monitoring, investigators have documented that spreading depolarizations (SD), a cytotoxic dysfunction of cerebral gray matter that has been well-characterized through 60 years of research in animal models, are the dominant pathophysiologic process in peri-lesion cortex of many, but not all, severe TBI patients. Furthermore, it was found that the occurrence of SD as a secondary injury process in patients is an independent predictor of worse neurologic outcomes. Thus, monitoring of SD as a heterogeneous mechanism in TBI may allow selective use of therapy in only those patients who might benefit. Here the investigators will conduct a randomized Phase 2 feasibility trial that uses real-time SD monitoring to guide implementation of a tier-based protocol of intensive care therapies aimed at SD suppression. The study is based on the hypothesis that outcomes from severe TBI can be improved by targeting intensive care therapies to suppress the pathology of SDs as a brain marker and mechanism of secondary injury. The objective of this study is to test the feasibility of this approach to intensive care management of severe TBI in a Phase 2 trial that uses real-time SD monitoring to guide administration of prescribed therapies to suppress SD. The aims are to (1) determine the feasibility of real-time SD monitoring to guide intensive care management of severe TBI, and (2) determine the effect of SD-guided vs. standard care management to reduce secondary brain insults in severe TBI. This is a randomized Phase 2 clinical trial enrolling approximately 72 patients at 3 sites. Patients requiring neurological surgery for emergency treatment of TBI will be enrolled. The need for surgery allows for the placement of an electrode strip on the brain during surgery for subsequent electrocorticography (ECoG). ECoG data will be monitored continuously in real-time for the occurrence of SDs during intensive care. When SDs are observed, these patients (~60%, or n=43) will be randomized 1:1 to either standard (control) or SD-guided care. In the standard care arm, treatment will follow local and national guidelines with blinding to further ECoG results. In the SD-guided arm, treatment will follow a tiered-based protocol with escalation and de-escalation based on efficacy to suppress further SD pathology. Treatments will include use of ketamine sedation and adjusted targets for plasma glucose, cerebral perfusion pressure, temperature, and end-tidal CO2. As outcomes, the accuracy of real-time SD scoring and compliance with protocol tier assignment and therapy implementation will be assessed. The burden of SD pathology, other measures of cerebral physiology (intracranial and cerebral perfusion pressures, and brain oxygenation), and medical complications will also be compared between the two study arms.

Learn More about INDICT
513-558-2577
H. Claude Sagi, MD

H. Claude Sagi, MD

Trauma

Using Exam Under Anesthesia to Guide Pelvic Surgery for Partially Unstable (B-Type) Injuries

This study will help surgeons decide how best to treat certain partially unstable pelvic fractures ("B‑Type" injuries). During surgery, doctors perform an exam under anesthesia (EUA) that gently stresses the pelvis to see how stable it is. Based on what the exam shows, some patients will not need fixation, some will need fixation in the front (anterior), and others may benefit from fixation in both the front and back (anterior + posterior). When both surgical choices are reasonable, patients will be randomly assigned to one of the two standard options (front only or front + back). Randomization is a fair way to compare treatments that are both commonly used. The goal is to improve recovery and function, reduce complications like loss of alignment or hardware failure, and avoid unnecessary procedures. After surgery (or nonoperative care if no fixation is needed), participants will return for routine clinic visits with X‑rays at about 6 weeks, 3 months, 6 months, and 12 months. At these visits, doctors will check healing and ask participants to complete short questionnaires about their day‑to‑day function and well‑being. All personal information is kept secure. Consent includes an explanation of privacy protections and what participation involves. This study may help future patients by showing when it is safe to use less surgery and when additional stabilization improves outcomes.

Laura Ngwenya, MD, PhD

Laura Ngwenya, MD, PhD

Neurotrauma | TBI/Concussion

Blood Test for Traumatic Brain Injury

This study will enroll adults who come to the emergency department after a head injury and have a head CT scan as part of their care. The research has two parts: one aims to develop a blood test that helps diagnose TBI and predict recovery, and the other follows hospitalized patients to see if blood markers can detect new or worsening brain problems while in hospital. Participants will have blood samples taken early after injury and be followed with clinical checks, imaging done for care (CT or MRI), and outcome assessments at about 2, 14, 28, and 90 days. The study will compare blood marker results with imaging, clinical judgment, and standard outcome scales to find whether the blood test can accurately identify injury, predict recovery, and spot secondary events.

Learn More about Blood Test for Traumatic Brain Injury
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.

Charles Prestigiacomo, MD

Charles Prestigiacomo, MD

Neurotrauma | Vascular

Phase 2

PPF Block for Post SAH Headache

This is a phase II, randomized, double‑blind trial testing whether a bilateral pterygopalatine fossa (PPF) injection can reduce opioid use for acute headache after an aneurysmal subarachnoid hemorrhage (SAH). Participants who are adults hospitalized soon after a spontaneous SAH and who need strong opioid pain medicine are randomized to receive either an active PPF block (ropivacaine plus dexamethasone) or a saline injection as a placebo. The study compares opioid use in the 24 hours after each injection across a 48‑hour double‑blind period. Safety is monitored with imaging to check for radiographic vasospasm at 48 hours, and tolerability is measured by whether participants accept a second injection at 24 hours. The trial also measures intracranial artery flow with transcranial Doppler around the time of the injections to watch for changes. The goal is to find a safer, opioid‑sparing way to treat severe headache after SAH without increasing the risk of vasospasm.

Learn More about PPF Block for Post SAH Headache
513-558-1012
Laura Ngwenya, MD, PhD

Laura Ngwenya, MD, PhD

Neurotrauma

Phase 2

TRACK TBI Precision Medicine Part 3

This is a randomized phase 2 trial testing an FDA approved drug given off label to adults with moderate to severe traumatic brain injury (TBI). Participants who are treated within 24 hours of injury are randomly assigned to receive the study drug or a placebo. The main goal is to see if the drug improves short term functional outcome measured at 4 weeks. The study also looks at blood markers of brain injury, standardized tests of consciousness, brain MRI measures, longer term function and cognition, quality of life, and caregiver burden up to six months after injury. Enrollment is by invitation and a legally authorized representative provides consent when the patient cannot. Participants must be able to undergo MRI and meet study blood test criteria. Certain medical conditions such as severe other injuries, kidney or liver disease, active infections, pregnancy, or inability to follow up will disqualify a person from participation.

Learn More about TRACK TBI Precision Medicine Part 3