Office of Research
Clinical Trials

Imaging Voice After Laryngectomy

Adults who have had their voice box removed and use a voice prosthesis may join during a regular clinic visit. A special camera is added briefly to the routine exam to record how tissues vibrate to create voice. The study does not change care and offers no direct benefit.

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

Tracking Outcomes in People with Heart and Blood Vessel Conditions

This study collects medical information and blood samples from adults treated for serious heart and blood vessel problems. The goal is to better understand how these conditions affect health and recovery. Researchers will use information from regular medical care and may ask some participants to give blood samples during their hospital stay and possibly again after going home. They may also contact participants up to a year after leaving the hospital to see how they are doing. This study does not test any new treatment. It simply gathers information that may help doctors care for future patients with similar conditions.

Radiation Therapy With or Without Cisplatin in Treating Patients With Stage III-IVA SCC of the Head and Neck

This is a phase II study evaluating the disease-free survival (DFS) of patients with stage III-IV squamous cell carcinoma of the head and neck (SCCHN) and disruptive p53 mutations after primary surgical resection followed by postoperative radiotherapy (PORT) alone or PORT with concurrent cisplatin. Participants in Arm A will undergo IMRT 5 days a week for 6 weeks, and those in Arm B will receive the same RT plus weekly Cisplatin via IV.

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

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.

QDOT PAS study

This study is a real-world follow-up of people with symptomatic, drug-refractory paroxysmal atrial fibrillation who were treated with the commercially available QDOT MICRO system together with the VISITAG SURPOINT module. It is a non-randomized, observational sub-study of the REAL AF registry. Eligible patients (either enrolled prospectively or added retrospectively if they meet criteria) will have their treatment and outcomes tracked. Safety is checked from the procedure through the first 7 days after ablation. Effectiveness is measured by whether participants remain free of atrial arrhythmia at 12, 24, and 36 months after the procedure. Participants must be adults who can give consent and can complete follow-up visits. The study does not change clinical care; it records outcomes and any adverse events after standard-of-care treatment with the QDOT MICRO system and VISITAG SURPOINT.

Pasritamig With Docetaxel Study

This phase 3 trial tests whether adding pasritamig to standard chemotherapy (docetaxel) helps men with metastatic castration resistant prostate cancer live longer without their disease getting worse on scans. Eligible men must have prostate adenocarcinoma that has spread, be on hormone lowering treatment or surgically castrated, have had at least one prior androgen receptor targeted therapy, and be in generally good health for cancer treatment. Participants are randomly assigned to receive pasritamig plus docetaxel or docetaxel alone. Doctors will use imaging scans to track when the cancer progresses, and will also measure overall survival, pain and quality of life, PSA blood changes, need for more treatment, bone related problems, tumor response if measurable, and side effects. Blood tests, scans, and questionnaires are used during treatment and for follow up. The main question is whether the combination delays radiographic progression compared with chemotherapy alone.

This study may be appropriate for those with: Metastatic Cancer

Study of CDK4/6 Inhibitor Dosing in Older Metastatic Breast Cancer Patients

This study seeks to help older patients (65 years and above) with metastatic breast cancer by testing different dosing strategies for CDK4/6 inhibitors. It aims to determine if starting these medications at a lower dose and increasing as tolerated could help patients manage side effects better, enabling them to continue their treatment longer. Participants can choose between the drugs palbociclib or ribociclib and an endocrine therapy, with dosing randomly assigned to either start at full dose (common practice) or begin at a lower dose and increase if tolerated. The trial will track the length of time patients stay on their medication, the side effects experienced, and overall survival and quality of life.

This study may be appropriate for those with: Metastatic Cancer

A Study to Compare Two Surgical Procedures in Individuals With BRCA1 Mutations to Assess Reduced Risk of Ovarian Cancer

The purpose of the study is to compare two surgical procedures and their ability to decrease the risk of developing ovarian cancer for pre-menopausal women with BRCA1 mutations. Participants will choose to undergo surgery to remove the fallopian tubes only and plan to have the ovaries removed in the future (BLS group) or remove the fallopian tubes and ovaries at the same time (BSO group).

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

Comparing Treatments for Advanced Non-small Cell Lung Cancer

This clinical study is looking at the effectiveness of two different drug combinations as a first-line treatment for people with advanced non-squamous non-small cell lung cancer. Researchers want to know if the combination of Nivolumab and Relatlimab with chemotherapy works better than Pembrolizumab with chemotherapy. Participants must have cancer in stage IV or recurring after initial treatments and have a certain level of tumor marker known as PD-L1. They will be randomly placed in one of the two treatment groups. The study will measure which treatment helps people live longer and other factors, like how long it takes for the cancer to start growing again, the overall response rate, and the duration of response. Researchers will also keep track of any side effects experienced by participants during the study, which will last up to five years for some outcomes.

This study may be appropriate for those with: Recurrent Cancer

Measuring Tongue Strength and Swallowing

Adults having a routine swallow x-ray can join a brief tongue strength test to see how tongue function relates to swallowing.

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.

Use of a new medication for prevention of fetal/neonatal thrombocytopenia (low platelets)

Fetal neonatal alloimmune thrombocytopenia (fNAIT) is a rare disease in pregnancy in which women develop antibodies against proteins on platelets (the cells in our blood that are help with clotting). These antibodies can cross the placenta in pregnancy and, if the fetus has that protein on his/her platelets, they can cause destruction of these cells. This results in thrombocytopenia (low platelets) and can lead to severe bleeding events. Standard prevention of disease in pregnancy includes immune suppression with something called IVIG and prednisone. We are comparing this treatment to a novel treatment using a medication called nipocalimab, a treatment that aims to block transfer of the antibodies across the placenta. Patients will be randomly assigned to receive either nipocalimab or the IVIG+Prednisone, and we will monitor the safety and response in the fetus and baby.

LTI03 Phase 2 IPF Study

This study tests LTI-03, an experimental inhaled medicine, in people with idiopathic pulmonary fibrosis (IPF). The drug is given as powder capsules that participants inhale using a device. About 120 people with IPF diagnosed within the past 5 years will be randomly assigned to low or high dose LTI-03 or matching placebo and neither they nor the study staff will know which they receive. The study includes a 28-day screening period, 24 weeks of treatment, and a 4-week follow-up. Participants will make up to nine clinic visits for safety checks, breathing tests, blood samples, symptom questionnaires, and lung scans at the start and end of treatment. The study will look at side effects and whether LTI-03 affects lung scarring, lung function, and symptoms compared with placebo.

Vedolizumab and Tofacitinib in UC

This open-label, single-group study will enroll about 65 adults with moderate to severe ulcerative colitis who have not successfully treated their disease with 1-2 prior TNF blocker drugs. All participants receive a combination of vedolizumab (300 mg IV) and tofacitinib (10 mg oral) for 8 weeks. Those who show a clinical response at Week 8 will stop tofacitinib and continue vedolizumab alone for 44 more weeks. The study aims to see how many people reach clinical remission early (Week 8) and maintain remission up to Week 52, and to collect safety and quality-of-life information. Participants are followed for safety for at least 26 weeks after their last dose. The study includes assessments of symptoms, endoscopy, laboratory markers, quality-of-life questionnaires, and monitoring for side effects.

Study on Safety of Treprostinil for Pulmonary Hypertension

This study is testing a drug called LIQ861, which is inhaled as a dry powder, to see if it is safe for patients with certain kinds of pulmonary hypertension (PH), specifically WHO Group 3 PH and ILD. The main goal is to check the safety and tolerability of the drug, while secondary goals include examining patients' exercise ability and other health markers. Around 60 people with PH related to lung diseases are expected to join the study. To be eligible, participants must be able to walk a certain distance and have stable medication. People with certain heart conditions or recent infections cannot participate.

Youth Weight Gain OLZ SAM vs Olanzapine

This is a 52-week, randomized, double-blind study in children and teens with schizophrenia or bipolar I disorder. Participants will get either OLZ/SAM (olanzapine combined with samidorphan) or olanzapine alone. The main goal is to compare weight change using BMI Z-score at 12 weeks. The study also looks at how many kids have a meaningful BMI Z-score increase, waist size, symptom scores for schizophrenia or bipolar disorder, time until they stop the study drug, and any side effects up to 52 weeks. Eligible participants are aged 13-17 for schizophrenia or 10-17 for bipolar I, are outpatient-capable, have caregiver support, and are either on olanzapine now or had a poor response to another antipsychotic. People are not allowed in the study for reasons such as certain other psychiatric or neurologic problems, recent opioid use, recent olanzapine exposure or poor response, extreme BMI, diabetes or recent changes in weight programs. Safety and symptoms will be checked regularly during the study.

GS 0415 in People With HIV Study

This is a Phase 1b study testing an investigational drug called GS-0415 in adults with HIV whose virus is already well controlled on HIV medicines. The study will test increasing single doses (single ascending dose, SAD) and increasing multiple doses (multiple ascending dose, MAD) given either under the skin (subcutaneous) or into a vein (intravenous). Some participants will get the drug and others will get placebo; the study is single-blind so participants do not know which they receive. The main goals are to check safety, tolerability, and how the body handles the drug (how much is in the blood over time). People must be 18–65, on stable HIV treatment for at least a year, have suppressed viral load, and meet basic weight and health rules. The study will monitor side effects, lab tests, immune measures, drug levels in blood, and whether participants make antibodies against GS-0415. Participation lasts up to about 99 days depending on the dose group.

APS Phenotyping Study

This is a prospective observational study of adults hospitalized with or at risk for ARDS, sepsis, or pneumonia. Participants give clinical information, answer questionnaires, and provide biological samples (blood, urine, stool). If on a ventilator, respiratory samples are collected. Data and samples are gathered while in the hospital and again after discharge at 3, 6, and 12 months. The study aims to sort patients into biologic subgroups (phenotypes), find measurable markers tied to those groups, understand illness severity and recovery, and build a biobank for future research into causes and new treatments. There is no experimental drug or therapy in this study; it focuses on observation, testing, and sample collection to improve understanding of these critical illnesses.

Study on Alzheimer's Disease Risk in Adults with Down Syndrome

This study aims to form a trial-ready group of adults with Down Syndrome (DS). It includes 120 healthy participants aged 25-55. Researchers will conduct cognitive and clinical tests to analyze relationships between brain markers and cognitive abilities. The goal is to improve future Alzheimer's clinical trials, focusing on disease patterns specific to people with DS. Participants will share data with another ongoing study for more comprehensive research outcomes.

Studying Swallowing With Ultrasound

Adults with normal or swallowing problems will have ultrasound imaging during swallowing tasks to better understand how the tongue and throat move. This may improve future swallowing evaluations.

Comparing Two Surgical Methods to Help Tibia Fractures Heal: Internal Compression vs Backslapping

This study is comparing two common ways surgeons help a broken shinbone (tibia) heal after placing a metal rod inside the bone. One method uses a technique called "backslapping" that allows small movements at the screw holes (dynamic locking). The other method uses the rod to gently squeeze the fracture together (internal compression) and then holds it firmly (static locking). Both methods are standard and use approved implants. Adults with a straight‑across tibia fracture may qualify. Participants are randomly assigned to one of the two methods. Everyone may put full weight on the leg right after surgery unless the treating team advises otherwise for safety. Patients return for checkups with X‑rays at around 6, 12, 24, and 52 weeks so the team can measure healing and any complications. The study's main goal is to learn which method leads to faster and more reliable bone healing and to understand any differences in risks like implant breakage, infection, or the need for additional procedures. What we learn may help future patients and surgeons choose the approach that offers the best chance of strong, timely healing.

Blood Test for ctDNA in Guiding Immunotherapy After Bladder Cancer Surgery

This study investigates whether a blood test can detect leftover cancer after bladder surgery and guide further treatment using immunotherapy. It aims to identify patients who might need additional treatment to prevent cancer from coming back. The study uses blood tests to look for circulating tumor DNA (ctDNA), which can indicate cancer presence. Patients testing positive for ctDNA might receive immunotherapy drugs nivolumab and relatlimab, while those who test negative might not get additional treatment immediately. This research hopes to improve survival rates and quality of life for bladder cancer patients by tailoring immunotherapy based on ctDNA results.

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

DISP 10 Advanced GI Cancer Study

This is an early phase (Phase 1) study testing DISP 10, a combination of an engineered adenovirus (DV-10) and a CAR T cell therapy (idecabtagene vicleucel or ide‑cel). Adults with advanced or metastatic cancers of the esophagus, gastroesophageal junction, stomach, or colon who have measurable disease and at least one site for biopsy may join. The study has two parts: Part 1 slowly increases doses to find a recommended dose for expansion, focusing on safety and dose‑limiting toxicities. Part 2 treats more participants at that dose to learn about safety and whether tumors shrink or stabilize. Main goals are to record side effects, establish a safe dose, and measure tumor response. Participants must have good organ function and no major infections, recent transplants, or prior similar viral or CAR T therapies. Follow up includes frequent checks after treatment and ongoing monitoring for up to 2 years, with long term survival follow up possible up to 15 years.

This study may be appropriate for those with: Metastatic Cancer

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