Office of Research
Clinical Trials

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.

Colon Adjuvant Chemotherapy Based on Evaluation of Residual Disease (CIRCULATE-US)

COLON ADJUVANT CHEMOTHERAPY BASED ON EVALUATION OF RESIDUAL DISEASE (CIRCULATE-US)

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

New Surgical Tool for Brain and Skull Base Surgery

This research is studying a surgical tool called DuraStat that is used to help close the protective lining around the brain during certain skull base surgeries done through the nose. Sometimes this lining is opened during surgery and needs to be carefully repaired to prevent fluid leaks or infection. The study will follow adults who are already having this type of surgery and need a repair during the procedure. Doctors will look at how well the repair works and how patients heal over time. Follow-up visits are part of normal surgical care, and participation does not require extra procedures beyond standard treatment.

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.

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.

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.

Testing Drug Delivery to the Inner Ear

Adults undergoing ear surgery may allow discarded tissue to be studied in the lab to improve future drug delivery to the ear.

Testing a wearable device for seizures

This study tests a wearable device that tracks seizures, heart rhythm, breathing, and oxygen levels while people are already in the hospital for epilepsy monitoring. Participants wear the devices during their hospital stay. The information collected may help improve future seizure detection devices.

AT1501 Kidney Transplant Study

This is a Phase 1b, open-label study that will test AT-1501 in up to 48 people receiving a first kidney transplant. AT-1501 is given with standard transplant medicines: rATG as induction, low-dose corticosteroids, and mycophenolate for maintenance. The study will track safety issues, measure how the drug behaves in the body (drug levels and related measures), and look for signs that it helps prevent rejection. Safety will be followed through the study (about up to 20 months on average). Pharmacokinetic sampling is planned soon after the first dose and again at steady state around Month 3. The study is single-arm, so every participant receives AT-1501 alongside routine transplant care.

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.

Stem Cell Transplant V/S BAT Therapy

This is a Randomized study to compare the efficacy, safety, immunologic effects, and cost-effectiveness of myeloablative and immunoablative therapy followed by autologous hematopoietic stem cell transplant (AHSCT) versus best available therapy (BAT) over 72 months in participants with relapsing MS and continued MS disease activity despite treatment with DMTs.

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.

Improving Instructions After Sinus Surgery

Adults having sinus surgery will receive either standard or improved written instructions. About one week later, they will answer questions about how helpful and clear the instructions were.

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.

Study on Teclistamab and Talquetamab for Treating Multiple Myeloma

This study is testing two new treatment combinations for people with newly diagnosed multiple myeloma who can't have a stem cell transplant right away. It explores if mixing new drugs, teclistamab and talquetamab, with daratumumab and lenalidomide works better than the usual treatment that includes daratumumab, lenalidomide, and dexamethasone. The main goal is to see how long participants live without their disease getting worse. Researchers will also monitor how many people have no signs of cancer after a year. People who join this study should not have been treated for multiple myeloma before (except for some steroids) and must meet health criteria like not planning pregnancies. It excludes people with recent severe health issues or allergies to the drugs used. The study could last up to nine years for each participant.

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

SPARX3

This study is a Phase III multi-site, randomized, evaluator-masked, study of endurance exercise on 12 month, 18 month, and 24 month changes in the MDS-UPDRS Part III score. 370 participants will be randomly assigned to 2 groups: 1)60-65% HRmax and 2)80-85% HRmax 4 times per week. Secondary aims will test hypotheses related to ambulatory mobility, daily activity, cognition, fitness, quality of life, measures of dopaminergic neuronal integrity and blood-derived biomarkers of inflammation and neurotrophic factors.

Cor TRICUSPID ECM Valve Study

This study checks the safety and performance of the Cor TRICUSPID ECM Valve (and a pediatric version) when used to replace a broken or leaking tricuspid heart valve. Adults and children who need surgical tricuspid valve replacement may take part. Before surgery participants have a baseline check, then they get the valve implanted during open heart surgery. Follow-up exams happen at hospital discharge, 30 days, 6 months, 12 months, and then every year up to 5 years. The study will track whether the valve is implanted successfully, whether it works to reduce valve leakage and improve symptoms, and whether there are device‑related complications such as infection, valve failure, or need for another procedure.

AMXT1501 and DFMO With Standard Care

This open-label Phase 1b/2 study tests two oral drugs, AMXT 1501 and DFMO, given together with standard treatments in people with advanced ER+ / HER2- breast cancer or with unresectable or metastatic cutaneous melanoma. AMXT 1501 blocks tumor uptake of polyamines and DFMO lowers polyamine production; together they aim to reduce tumor-supporting molecules and possibly improve responses to standard therapy. In the breast cancer group the combo is given with fulvestrant and capivasertib. In the melanoma group the combo is given with pembrolizumab. The Phase 1b part uses a small dose-escalation plan to find a safe dose for Phase 2. The Phase 2 part will look for signs the treatment controls or shrinks tumors using standard tumor response rules. The study also checks drug levels in blood, changes in tumor tissue and immune genes, and overall safety. About 92 patients may be enrolled across the two groups. Participants will have screening tests, regular clinic visits each treatment cycle (28 days), imaging to measure response, and follow-up visits.

This study may be appropriate for those with: Metastatic Cancer

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.

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

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.

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.