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

ZEN003694 with Capecitabine for Advanced Solid Tumors

This phase I trial evaluates the safety, side effects, and optimal dosage of ZEN003694 combined with standard treatment capecitabine in patients with metastatic or unresectable solid tumors that have worsened after standard therapy. ZEN003694, a BET protein inhibitor, could inhibit tumor growth by targeting cells that produce excessive BET proteins. Capecitabine, an antimetabolite, converts into fluorouracil inside cancer cells to destroy them. The combination of ZEN003694 and capecitabine aims to safely treat these advanced cancers.

This study may be appropriate for those with: Metastatic Cancer

Evaluating Pegozafermin for Treating Liver Disease

This study is looking at how safe and effective a medication called pegozafermin is for people with liver disease called MASH, which involves an advanced form of 'fatty liver' known as cirrhosis. Participants in this study have a specific stage of liver damage known as stage F4 MASH. The study will help researchers understand if pegozafermin can improve liver health by looking at changes in liver fibrosis, a condition that causes the liver to become scarred. The study takes place over several years and involves regular testing including liver biopsies at the start and after two years to see if the liver disease has improved by one stage or more. It also looks at how the treatment affects liver functions over a longer period of up to five years.

Comparing Proton Therapy to Photon Radiation Therapy for Esophageal Cancer

This is a randomized trial for patients diagnosed with Esophageal Cancer comparing Proton Beam Therapy and Intensity Modified Photon Radiotherapy. Patients randomized to Arm 1 will undergo Proton Beam therapy with concurrent weekly chemo with paclitaxel/carboplatin. Patients in Arm 2 will undergo IMRT with concurrent paclitaxel/carboplatin. The primary endpoint of this study is Overall Survival.

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

Teclistamab Maintenance Study

This is a Phase 3 clinical trial for people with newly diagnosed multiple myeloma who have completed initial therapy and are starting maintenance treatment after autologous stem cell transplant. Participants are randomly assigned to one of three maintenance options: teclistamab plus lenalidomide, teclistamab alone, or lenalidomide alone. The study will compare how long people live without their disease getting worse (progression-free survival) and how many achieve a deep response with no detectable disease at 12 months. Participants will be followed during treatment and for long-term outcomes, including overall survival, quality of life, and safety, for up to about 8 years. The goal is to find whether teclistamab, by itself or with lenalidomide, gives better and longer-lasting control of myeloma than standard lenalidomide alone.

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

Trial of BNT113 and Pembrolizumab for HPV16+ Head and Neck Cancer

This study is for patients who have a type of head and neck cancer that is linked to a virus called Human Papilloma Virus 16 (HPV16). The research is exploring whether a new treatment, using a vaccine called BNT113 together with a medicine called pembrolizumab, works better than just using pembrolizumab alone. Pembrolizumab is already a common treatment for this kind of cancer. The study is being conducted by BioNTech SE and involves patients who haven't been treated with systemic therapy for their cancer before. The first part of the study looks at safety to make sure the new combination doesn't cause serious side effects. The second part of the study compares how long patients live and how well their cancer responds to the different treatments. Those interested in participating need to have certain types of tumors that are both HPV16 positive and express a protein called PD-L1.

This study may be appropriate for those with: Metastatic Cancer

Genetics Guided Escitalopram Study

This study will enroll about 132 teens ages 12-17 who have generalized, social, and/or separation anxiety. For 12 weeks, participants are randomly assigned to one of two ways of giving the antidepressant escitalopram: standard dosing or dosing guided by a genetic test that predicts how they process the drug. The goal is to see whether using genetic information leads to better anxiety relief and fewer side effects, especially activation (increased restlessness or irritability). The study compares changes in anxiety scores over 12 weeks and monitors safety and activation. Caregivers help with safety checks and medicine monitoring. The study includes a screening visit, a baseline visit, and regular follow-up visits during the 12-week treatment period.

How eating a meal affects tongue strength and fatigue

This study is exploring how eating a normal meal may cause tongue fatigue and whether this differs by age. Healthy younger and older adults will complete simple tongue strength tasks before and after eating a standardized meal. These tasks help researchers understand how eating affects the muscles used for chewing and swallowing. Participation involves a single visit and does not change medical care. The results may help improve understanding of fatigue related to eating as people age.

Efficacy and Safety of Iptacopan for IC-MPGN

This study is investigating iptacopan's effectiveness and safety for treating idiopathic immune complex-mediated membranoproliferative glomerulonephritis (IC-MPGN). People aged 12-60 with IC-MPGN who are already on stable treatment may participate. The study will compare iptacopan with a placebo in terms of reducing protein levels in the urine and improving kidney function (measured by eGFR). It also assesses whether patients feel less fatigued. After completing the study, participants can choose to continue iptacopan in another study. The study involves safety monitoring, includes vaccinations for certain infections, and is open only to those meeting specific health criteria without certain exclusions.

Adding SNDX-5613 to the Standard Chemotherapy Treatment for Newly Diagnosed Patients With Acute Myeloid Leukemia

A Phase 1b Study of Menin Inhibitor SNDX-5613 in Combination with Daunorubicin and Cytarabine in Newly Diagnosed Patients with Acute Myeloid Leukemia and NPM1 Mutated/FLT3 Wildtype with Higher-Risk Features or MLL/KMT2A Rearranged Disease. This phase Ib trial evaluates the safety, side effects, and optimal dosage of SNDX-5613 in combination with standard chemotherapy (daunorubicin and cytarabine) for patients with newly diagnosed acute myeloid leukemia (AML) harboring NPM1 or MLL/KMT2A gene mutations. SNDX-5613 inhibits specific intracellular signaling pathways essential for the survival of cancer cells. Chemotherapy agents like daunorubicin and cytarabine work by various mechanisms to halt cancer cell proliferation, either by directly killing the cells, preventing their division, or inhibiting their spread. The hypothesis is that adding SNDX-5613 to conventional chemotherapy could potentially enhance cancer control, leading to longer periods of remission or stabilization compared to chemotherapy alone.

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

Comparing Surgical vs Nonsurgical Care for Fragility Pelvic Fractures: The FLIPER Pilot Study

Fragility fractures of the pelvis are increasing as the population ages. Doctors often treat these injuries either with surgery or with nonsurgical care focused on early movement and rehabilitation. It is not yet clear which option works best for which patients, and previous studies have had limitations. The FLIPER pilot study is designed to prepare for a larger, more definitive study by testing whether it's practical to compare these treatments fairly and safely. People aged 60 and older with a specific type of low‑energy pelvic fracture (LC1) may be eligible. After consent, the research team collects information from the hospital chart and from the patient or a family member. The care team decides whether surgery or nonsurgical care is best, based on their usual clinical judgment. About four months after the injury, participants (or their caregivers) are contacted to see how they are doing. The study focuses on three important outcomes at about four months: Survival (whether the patient is still living), Ability to walk across a room, and "Days at home," meaning the number of days not spent in a hospital or facility. The team will also ask patients and surgeons if they would be willing to take part in a future randomized study that directly compares surgery to nonsurgical care. This helps researchers learn whether a larger trial would be acceptable and realistic. No experimental treatments are involved. All care decisions are made by the medical team as part of normal practice. The information learned from this pilot will guide the design of a larger study to improve treatment decisions and outcomes for older adults with fragility pelvic fractures.

KarXT for Bipolar I Mania

This is a Phase 3, randomized, double-blind, placebo-controlled inpatient study testing KarXT for adults hospitalized with an acute manic episode of Bipolar I disorder (including mixed features). The main goal is to see if KarXT reduces mania symptoms more than placebo over a 3-week treatment period, measured by change in the Young Mania Rating Scale (YMRS) and clinician global ratings. Participants must be hospitalized for the episode, meet minimum severity scores, and stop other psychotropic drugs before starting. People with other main psychiatric disorders, recent substance use disorders, high suicide risk, or significant liver disease are excluded. The total time in the study, including screening and a safety follow-up, is up to 7 weeks.

Reduced Elective Nodal and CTV Dose for HPV+ Oropharyngeal Squamous Cell Carcinoma

The purpose of this research is to study if a decrease in the dose of radiation to regions which have no visible cancer will be as effective as the standard dose. The dose to all visible cancer remains unchanged to the standard radiation approach. The researchers believe that a lower dose could be just as helpful for treating your cancer, while reducing the side effects of radiation and improving quality of life. The current standard care treatment for OPSCC can have debilitating side effects. The researchers believe that using a decreased dose of 30 Gy from 46-54 Gy to regions without visible cancer but which have a risk of microscopic cancer might be just as effective for treating your cancer with less side effects. The combination of these approaches is not considered the current standard of care and will be considered research. You will continue to receive standard systemic therapy of cisplatin during your radiation therapy.

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

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.

Study on UB-VV111 and Rapamycin for CD19+ B-cell Malignancies

This Phase 1 research involves the new drug UB-VV111, tested with or without another drug called Rapamycin, in people with specific B-cell cancers that have returned or don't respond to existing treatments. The goal is to understand if these treatments are safe and how well they work against cancer. Participants need to meet certain criteria, such as being 18 years or older, having specific types of relapsed or refractory B-cell lymphomas or leukemia, having no serious uncontrolled health conditions, and having good organ function. People can't participate if they are pregnant, have certain infections, or are part of another trial. Expected outcomes are monitored over a two-year timeframe.

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

DECADE-Brain Health study

Intracerebral hemorrhage (ICH) is the most extreme subtype along the spectrum of CSVD that includes white matter hyperintensity (WMH), small vessel (lacunar) ischemic stroke and vascular cognitive impairment. We propose to re-enroll 400 (275 non-Hispanic European descent and 125 African-descent) participants of i3C DECADE study, (MPI: Bazzano, Urbina and Carmichael) which is following biracial cohorts in the Cincinnati, Ohio regions originally recruited as children in the 1970s and 1980s, for a 3-year (+/- 6 months) follow-up MRI, additional serial cognitive examinations and detailed dietary histories which will include a polyamine specific history and serial blood sampling. The proposal will copy the i3C DECADE exam including an identical MRI protocol and use the same recruitment and retention tools.

Phase II Trial of Asciminib, Prednisone, Blinatumomab, for Newly Diagnosed Ph+ Acute Lymphoblastic Leukemia

This phase II study tests whether adding asciminib to a treatment plan of dasatinib, prednisone, and blinatumomab helps adults newly diagnosed with Philadelphia-chromosome positive (Ph+) acute lymphoblastic leukemia (ALL). Treatment has three parts: an induction phase to try to put the leukemia into remission, a post-remission consolidation phase with repeated 42-day cycles, and a maintenance phase where patients take oral drugs for up to five years if they benefit. Doctors will check response by measuring BCR-ABL levels in blood/marrow and by flow cytometry for measurable residual disease. Main goals are to see how many people reach a major molecular remission by about day 85 and to track remission rates, survival, and side effects over time. The study also collects samples to study genetic changes linked to response or resistance.

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

Child and Teen Bipolar Network

This study follows about 80 youth ages 9-19 who have bipolar spectrum disorders or cyclothymic disorder. After a screening and baseline visit (which includes a diagnostic interview and a blood draw to measure inflammation), families take part in regular follow-up for 12 months. Parents complete weekly online ratings of their child's symptoms. The study team tracks the youth's medications and any psychosocial therapies they receive as part of usual care. Major visits include baseline/intake and repeat assessments at 6 and 12 months, using standard questionnaires about mood, behavior, family conflict, quality of life, anxiety, and substance use. The goals are to improve early and accurate diagnosis, learn which signs predict better or worse outcomes (focusing on mood instability and C-reactive protein), and develop standardized tools and procedures that clinics can use to treat youth with or at risk for bipolar disorder.

IkT001Pro Pulmonary Arterial Hypertension

This was a Phase 2, randomized, double-blind, placebo-controlled trial testing two dose levels of an experimental drug called IkT-001Pro in people with pulmonary arterial hypertension (PAH). About 150 people were planned to join at multiple global sites. The study had two parts: a 26-week blinded treatment period comparing 300 mg and 500 mg doses against placebo, followed by a long-term 36-month extension where participants could continue on a study dose. The main goals were to measure the drug�s effect on the resistance in lung blood vessels and to evaluate safety and tolerability. Other goals included measuring walking distance, symptoms, clinical worsening events, quality of life, and drug levels in the body. Participants needed a confirmed diagnosis of PAH, be symptomatic (WHO class II or III), be on stable PAH therapy, and meet walking test criteria. The study was withdrawn and did not complete enrollment.

Efficacy and Safety of Adjuvant in Patients With Resected Pancreatic Ductal Adenocarcinoma

This study is evaluating an experimental drug called autogene cevumeran in patients with pancreatic ductal adenocarcinoma that has been resected (surgically removed). The goal is to find out whether combining these newer therapies (atezolizumab and autogene cevumeran) with standard chemotherapy is safe and more effective at reducing the risk of cancer returning compared to chemotherapy alone.

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

Study of Biomarker-Based Treatment of Acute Myeloid Leukemia

This screening and multi-sub-study Phase 1b/2 trial will establish a method for genomic screening followed by assigning and accruing simultaneously to a multi-study "Master Protocol (BAML-16-001-M1)." The specific subtype of acute myeloid leukemia will determine which sub-study, within this protocol, a participant will be assigned to evaluate investigational therapies or combinations with the ultimate goal of advancing new targeted therapies for approval. The study also includes a marker negative sub-study which will include all screened patients not eligible for any of the biomarker-driven sub-studies.

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

LAAOS - 4

This multicenter, open-label, randomized controlled trial evaluates whether catheter-based endovascular closure of the left atrial appendage (LAA) reduces ischemic stroke or systemic embolism in patients with atrial fibrillation who remain at high stroke risk despite treatment with oral anticoagulants. Eligible participants have persistent or permanent AF, or paroxysmal AF with prior stroke, a CHA2DS2-VASc score ≥4, and have been on oral anticoagulation for at least 90 days before enrollment. Participants are randomized to receive LAA occlusion using devices such as the WATCHMAN in addition to standard care versus continued medical therapy. Endpoints are assessed by blinded adjudicators, and participants are followed until a total of 265 primary efficacy events have occurred (estimated average follow-up about 4 years). The primary outcome is prevention of ischemic stroke or systemic embolism; safety outcomes include procedural complications, bleeding, and device-related events.

Study of IDE196 in Patients With Solid Tumors Harboring GNAQ/​11 Mutations or PRKC Fusions

This is a Phase 1/2, multi-center, open-label basket study designed to evaluate the safety and anti-tumor activity of IDE196 in patients with solid tumors harboring GNAQ or GNA11 (GNAQ/11) mutations or PRKC fusions, including metastatic uveal melanoma (MUM), cutaneous melanoma, colorectal cancer, and other solid tumors. Phase 1 (dose escalation - monotherapy) will assess safety, tolerability and pharmacokinetics of IDE196 via standard dose escalation scheme and determine the recommended Phase 2 dose. Safety and anti-tumor activity will be assessed in the Phase 2 (dose expansion) part of the study. Phase 1 Tablet and Food Effect Pharmacokinetic (PK) Substudy will assess the PK profile of IDE196 tablet and evaluate the effects of food on the PK profile of IDE196 tablet Phase 1 (dose escalation - binimetib combination) will assess safety, tolerability and pharmacokinetics of IDE196 and binimetinib via standard dose escalation scheme and determine the recommended Phase 2 dose. Safety and anti-tumor activity will be assessed in the Phase 2 (dose expansion) part of the study. Phase 1 (dose escalation - crizotinib combination) will assess safety, tolerability and pharmacokinetics of IDE196 and crizotinib via standard dose escalation scheme and determine the recommended Phase 2 dose. Safety and anti-tumor activity will be assessed in the Phase 2 (dose expansion) part of the study.

This study may be appropriate for those with: Metastatic Cancer

Studying TRX319 Cell Therapy for Progressive Multiple Sclerosis

This research study is testing an investigational cell therapy called TRX319 for adults with primary progressive multiple sclerosis (PPMS) or secondary progressive multiple sclerosis (SPMS). The goal is to learn whether TRX319 is safe and to look for signs that it may help slow or improve disease progression. Participants will receive a single intravenous infusion of TRX319. Some participants may also receive bendamustine before the infusion, depending on the study group. The study includes screening tests, physical examinations, blood tests, MRI scans, spinal fluid testing, and assessments of walking, hand function, vision, and thinking abilities. Participants will be followed for about one year after treatment. Information from this study may help researchers develop new treatment options for people with progressive forms of multiple sclerosis.

Safety and Effectiveness of PYX-201 in Solid Tumors

This study is testing a new drug called PYX-201 in adults with advanced solid tumors that have not responded to usual treatments or for whom there are no suitable treatment options. The goal is to find out what dose of the drug is safe and can be tolerated well. Researchers will monitor participants to see how their bodies react to the drug, including any side effects and how the drug moves through their system. Participants must be adults with certain cancers, such as breast, lung, or ovarian cancer, who meet health criteria like having normal kidney and liver function. The study aims to explore both the safety and preliminary effectiveness of PYX-201 over approximately 3 years. It is open-label, meaning all participants receive the drug, and no placebo is involved. Measurements will focus on potential toxicities and adverse events as well as biological markers from blood samples. Participants must not have severe infections or other active cancers. The research hopes to pave the way for further clinical development if results are promising.

This study may be appropriate for those with: Recurrent Cancer

AI Tool for Airway Anatomy

Adults will have brief ultrasound scans of the neck to help train a computer system to recognize airway structures, which may aid future emergency care.