Office of Research
Clinical Trials

TRI611 in ALK Positive NSCLC

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

This study may be appropriate for those with: Metastatic Cancer

Study of Ipatasertib with Chemoradiation for Head and Neck Cancer

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

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

Letrozole Study in Recurrent High Grade Gliomas

Patients will receive up to 20 mg of letrozole orally each day both before and after surgical resection. The primary endpoint of this study is the measurement of tumoral bioavailability of letrozole.

This study may be appropriate for those with: Recurrent Cancer

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

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

Amivantamab Versus Cetuximab in cSCC

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

This study may be appropriate for those with: Metastatic Cancer

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.

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.

Targeted Therapies Crohns Disease

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

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.

Contact UCCC CTO for Study Activation

Specific study details/protocols can be provided upon request

Afimkibart in Moderate Severe UC

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

Freiermuth ALTO

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

Anticoagulation in ICH Survivors

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

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.

HNSCC Longitudinal Multiomic Study

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

This study may be appropriate for those with: Metastatic Cancer

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.

Studying Airway Cells in the Lab

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

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

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

This study may be appropriate for those with: Metastatic Cancer

Cyclic Irrigation Expanded Access

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

Understanding Social Factors and Infant Health Outcomes

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

Mobile Intervention for Teen Suicide

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

Understanding genetic Parkinson's disease

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

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.

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.

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

Understanding chronic sinus and nasal inflammation

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

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.

Study of Rilvegostomig vs. Pembrolizumab with Chemotherapy for Lung Cancer

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

This study may be appropriate for those with: Metastatic Cancer

Neoadjuvant Chemotherapy, Excision And Observation vs Chemoradiotherapy For Rectal Cancer

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

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

Understanding Swallowing Exercises

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

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.

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

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

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

Empasiprubart versus IVIg in CIDP

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

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.

Cilostazol Prevent Recurrent Stroke

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

TQR-84 (Placebo Study)

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

Evaluating Nipocalimab for Reducing Risk of Severe HDFN in Pregnancies

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

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

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

This study may be appropriate for those with: Metastatic Cancer

How Straw Exercises Affect the Voice

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

Studying a Switch in Treatment for Relapsing Multiple Sclerosis

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

Understanding Flare-Ups in Chronic Sinusitis

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

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.

KarXT for Teen Schizophrenia

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

Radiation With Cetuximab or Chemotherapy

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

This study may be appropriate for those with: Metastatic Cancer

Treatment for adults with anxiety

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

Beat AML Biomarker Treatment Trial

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

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

INEBILIZUMAB IN ANTI-NMDA ENCEPHALITIS

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

Studying Airway Bacteria in Stenosis

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

Videofluoroscopic Swallowing Norms

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

Bladder Preservation Immunoradiation

This Phase II study tests whether combining the immune drug pembrolizumab with radiation therapy can allow people with muscle invasive bladder cancer to keep their bladder after the tumor has already shrunk from pre-surgery chemotherapy. Eligible patients have an excellent clinical response after neoadjuvant chemotherapy and will receive daily photon radiation to the bladder Monday through Friday for up to about 4 weeks while also getting pembrolizumab through an IV every 3 weeks. Before joining, patients have had a TURBT (a bladder tumor biopsy/removal procedure) and staging scans. The study tracks how long patients keep their bladder without cancer returning, whether they later need bladder removal (salvage cystectomy), survival outcomes, side effects, and patient-reported symptoms. Blood, urine, and tissue samples will be stored for future research. After finishing treatment, participants are followed regularly for up to 5 years.

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

Comparing Two Surgical Options for Stabilizing Metastatic Bone Disease in the Upper Thigh (PERFORM)

The PERFORM study is a major international research trial comparing two ways of treating cancer‑related bone disease in the upper part of the thigh bone (proximal femur). Some patients develop weak or broken bones in this area when cancer spreads to the skeleton, and surgery is often needed to help them walk safely and reduce pain. The study compares two surgical options: Resection and reconstruction - removing the damaged section of bone and replacing it with an implant. Internal fixation - strengthening the bone using plates, screws, or a rod placed inside the bone. Patients who qualify will be randomly assigned to one of the two procedures. Doctors want to know which option helps patients live longer, stay mobile, and spend more days at home during the year after surgery. The study also measures quality of life, physical function, pain levels, and time spent in hospitals or care facilities. About 334 patients from hospitals across Canada, the U.S., and other countries will participate. Everyone will be followed for one year after their surgery, with check‑ins and questionnaires at several time points. All surgeries and follow‑up visits are standard medical care. The goal of PERFORM is to provide strong evidence to guide surgeons on the best treatment for people with metastatic bone disease in the femur. By comparing these two common surgical approaches, the study will help determine which one offers better long‑term outcomes and quality of life for cancer patients.

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

Using a Blood Test to Tailor Blood‑Clot Prevention After Surgery for Metastatic Bone Disease

Cancer patients with metastatic disease that has spread to the bones are at high risk for blood clots, especially after surgery. This study explores whether using a special blood test called thromboelastography (TEG) can help doctors choose the safest and most effective blood‑thinner medication for each individual patient. Before surgery, a small blood sample is tested using Rapid TEG to see how quickly and strongly the patient's blood forms clots. Based on this test, patients are placed into groups ranging from "low clotting tendency" to "high clotting tendency." Each group has a matching treatment plan to help prevent dangerous blood clots after surgery, using medications like aspirin or low‑molecular‑weight heparin (enoxaparin). All participants also have an ultrasound scan of both legs to check for blood clots before surgery, and a second scan six weeks later. Patients are monitored for signs of deep vein thrombosis (DVT), pulmonary embolism (PE), bleeding, need for transfusion, or return to the operating room. Participants complete short questionnaires measuring physical function, pain, and anxiety before surgery and again at several follow‑up visits through the first year. These help the research team understand how patients feel and function during recovery. No experimental treatments are used-only tests and medications that are already part of standard orthopedic and cancer care. The information learned will help doctors design a larger future study and may lead to more personalized, safer blood‑clot prevention for patients with metastatic bone disease.

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.

Understanding Drug Delivery to the Inner Ear

During routine ear surgery, small pieces of tissue that would otherwise be thrown away are studied in the lab to improve future hearing treatments.

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.

Study on IOV-4001 for Advanced Melanoma and NSCLC

This study is the first-in-human study of IOV-4001, a genetically modified autologous tumor- infiltrating lymphocytes (TIL) product. IOV-4001 is expected to have antitumor activity through its capacity to directly target and kill tumor cells in a manner that is similar to non-genome-edited TIL, but with the potential for enhanced antitumor activity due to disruption of PDCD1, the gene for programmed cell death protein-1 (PD-1).

This study may be appropriate for those with: Metastatic Cancer

Comparing the Outcome of Immunotherapy-Based Drug Combination Therapy With or Without Surgery

This phase III trial compares the effect of adding surgery to a standard of care immunotherapy-based drug combination versus a standard of care immunotherapy-based drug combination alone in treating patients with metastatic kidney cancer. Patients will receive 1 of the following 4 treatment options: Nivolumab 240 mg IV 1 q 2 weeks, Nivolumab 480 mg IV 1 q 4 weeks, Pembrolizumab 200 mg IV 1 q 3 weeks and Axitinib 5 mg oral Daily BID, OR Avelumab 10 mg/kg IV 1 q 2 weeks and Axitinib 5 mg oral Daily BID. Those in Arm 2 will also undergo a radical or partial nephrectomy. Efficacy will be measured by determining Overall Survival.

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

Higher Dose Radiation Therapy for Advanced Pancreatic Cancer Trial

This study is exploring if giving higher doses of radiation can help people with advanced pancreatic cancer live longer. Participants must have already undergone 4-6 months of chemotherapy and have stable disease without progression. There are two groups in the study. One group will receive standard treatment, which could include continuing chemotherapy, a normal dose of radiation, or observation. The other group will receive higher doses of radiation over a shorter period to see if it prolongs their survival. Patients will have regular follow-ups and will be checked through blood tests, imaging scans, and tissue biopsies. They are monitored over a period that includes every three-month checkups for two years and then yearly for another three years. This study aims to not only see if survival improves but examine side effects, quality of life, and any changes in disease progression.

This study may be appropriate for those with: Metastatic Cancer

Selective Cytopheretic Device Trial

This study will enroll about 200 adults in intensive care units who have acute kidney injury (AKI) and need continuous kidney replacement therapy (CKRT). Patients are randomly assigned to receive standard CKRT alone or CKRT plus up to ten 24-hour treatments with the Selective Cytopheretic Device (SCD). The SCD is a device used during CKRT that aims to calm overactive white blood cells (neutrophils and monocytes) to reduce inflammation. The main goal is to find out whether adding the SCD lowers the chance of death or needing ongoing dialysis 90 days after starting treatment. Other outcomes include kidney-related events at 90 days, need for dialysis at one year, days alive outside the ICU in the first 28 days, and 28-day death rate. Key rules: participants must be 18-80, have moderate to severe AKI when CKRT starts, have a high C-reactive protein, and have another serious organ problem. People are excluded if they are not expected to survive short-term, already on long-term dialysis, have certain infections or immune problems, are pregnant, or are in other situations that make the study unsafe or not useful. Follow-up includes checks up to 90 days and one year to track kidney recovery and survival.

Brain MRI in Adults with Sickle Cell Disease

The purpose of this study is to see whether inflammation is present in the brains of people with sickle cell disease and whether this inflammation may be a cause of decreased cognition (ability to learn/remember) in people with sickle cell disease. Brain images from people with sickle cell disease will be compared to brain images from people without sickle cell disease.

Testing Abemaciclib with 5-Fluorouracil for Metastatic Colorectal Cancer

This clinical trial is investigating how well two drugs, Abemaciclib and 5-Fluorouracil (5-FU), work together in treating people with colorectal cancer that has spread to other parts of the body and hasn't responded to other treatments. The study aims to discover the safest dose of the drug combination that patients can handle without severe side effects. Participants will take Abemaciclib by mouth twice daily, and receive 5-FU through a vein on specific days during each 28-day cycle. Throughout the study, various samples will be collected to track the effectiveness and side effects of the treatment. After finishing the treatment cycles, participants will be monitored every three months for follow-up. Researchers hope this combination will provide a new option for those with this difficult-to-treat cancer type.

This study may be appropriate for those with: Metastatic Cancer

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.

Emergency Contraceptive Metabolism Study

This study looks at why emergency birth control pills sometimes fail for some people and not others. The researchers will give participants a single dose of ulipristal acetate (UPA), the oral emergency contraceptive, and then watch how the body responds. They will use blood tests to measure UPA levels and ultrasound to see whether the ovary releases an egg (ovulation). The main question is whether genetic differences that affect the enzymes that break down UPA change how much drug is in the blood and whether the drug can stop or delay ovulation. Participants will be healthy people aged 18 to 40 with regular, ovulatory menstrual cycles. The study follows one menstrual cycle (about 30 days) and includes screening, the study dose, blood draws, and ultrasound checks. The goal is to better understand who is more likely to have emergency contraceptive failure and to help make emergency contraception work better for everyone.

Pramipexole vs Escitalopram Study

This is a Phase 2, open-label randomized trial that will compare two medicines for depression in people living with HIV: pramipexole extended release and escitalopram. Participants will be randomly assigned to one of the two treatments and followed for about 24 weeks. Study visits will check how participants are feeling, measure depression and thinking skills, and watch for side effects. A smaller optional sub-study will collect and study spinal fluid in up to 36 people to see how treatment affects brain inflammation markers.

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.

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.

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.

REAL AF - Catheter Ablation for Treating Atrial Fibrillation

This study looks into how catheter ablation works for treating people who have Paroxysmal or Persistent Atrial Fibrillation. By observing patients, the research team will gather data on how well these technologies help with atrial fibrillation over time, both in terms of effectiveness and safety. During the study, participants will have regular assessments before and after their catheter ablation procedures. The expected benefits are to determine how good these methods are at stopping irregular heart rhythms and ensuring patient safety.

ExoFlo EVs for ARDS Phase III

This Phase III randomized, double-blind, placebo-controlled trial tests an intravenous extracellular vesicle product called ExoFlo (from bone marrow mesenchymal stem cells) in hospitalized adults with moderate-to-severe ARDS. Participants receive either a single IV dose of ExoFlo (15 mL) or a matched placebo and are followed in hospital with assessments and additional follow-up through about Day 61. The main goal is to see if ExoFlo lowers 60-day all-cause mortality compared with placebo. Secondary goals include time to death, ventilator-free days, oxygen-free days, ICU-free days, and the rate of serious adverse events. Key eligibility includes adults 18-75 with ARDS that started within 7 days and meets clinical and imaging criteria; main exclusions include recent major trauma, long prior ventilation (>72 hours), severe liver disease, pregnancy, DNR status, ECMO, or recent investigational treatments.

Inotuzumab With Chemotherapy for Young Adults with Newly Diagnosed B-Cell ALL

This trial tests whether adding the antibody drug inotuzumab ozogamicin to a pediatric-style chemotherapy plan helps young adults (about ages 18-39) with newly diagnosed B-cell acute lymphoblastic leukemia (B-ALL). All patients first get a standard induction course of chemo. Those who respond are randomly assigned to either continue the standard multi-course chemotherapy plan or get the same chemotherapy plus inotuzumab given on days 1, 8, and 15 of a 28-day cycle (up to two cycles). The main goals are to confirm the added drug is tolerable and to see if it improves the time patients stay free of relapse or death (event-free survival). The study also looks at overall survival, disease-free survival, how much disease is left after treatment, genetic markers, drug side effects, drug levels, and how well patients take their oral medicines. Treatment can continue for months to years depending on the course, and patients are followed closely for many years after finishing treatment.

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

Cooling Treatment for Patients with Severe Lung Injury

This study looks at whether gently cooling the body can help people with severe lung injury get off the breathing machine sooner. Participants have a serious lung condition called ARDS that makes it hard to breathe. Researchers will compare standard care with a cooling approach that lowers body temperature slightly for two days. The goal is to see if cooling helps the lungs heal faster and improves recovery.

Comparing Two Surgical Approaches for Fixing Posterior Malleolus Fragments in Ankle Fractures

This study looks at two accepted surgical approaches used to repair a specific part of the ankle-the posterior malleolus-in patients who have trimalleolar ankle fractures. In some patients, surgeons directly fix the broken piece of bone in the back of the ankle. In others, surgeons use indirect techniques to reduce and stabilize the fragment without directly exposing it. Both methods are commonly used today, but it is not known which leads to better stability and long‑term recovery. Patients who require surgery and meet the study's criteria will be invited to participate. Before surgery, each person receives standard X‑rays and a CT scan, and fills out questionnaires about their daily function and overall health. During surgery, after the main ankle bones are fixed, the surgeon performs a series of stress tests on the ankle joint to see whether the syndesmosis-the ligaments between the tibia and fibula-needs to be stabilized. These tests are standard and help determine the best treatment for each patient. The surgery itself and all choices about implants, positioning, and fixation are made by the treating surgeon based on their usual clinical practice. After surgery, patients return for checkups at about 6 weeks, 3 months, 6 months, and 12 months. At these visits, patients complete short surveys about pain, activity, and function, and receive routine X‑rays (except at the initial 2‑week wound check). The goal of the study is to find out whether directly fixing the posterior malleolus fragment leads to better ankle stability, fewer complications, and improved function compared with indirect treatment. The study does not add extra costs, procedures, or risks beyond standard care. What we learn may help guide future treatment decisions and improve recovery for patients with this type of ankle fracture.

Testing New Treatment for Residual Cancer in B-cell Lymphoma Patients

This study is testing if a new experimental treatment named cemacabtagene ansegedleucel (or cema-cel for short) can help adults with large B-cell lymphoma, a type of blood cancer. Patients who have already finished one round of regular treatment and are still showing signs of leftover cancer according to a special test are being looked at. The study compares cema-cel treatment versus just watching the patients to see which helps more in preventing cancer events and eliminating leftover cancer cells. Participants must have completed standard initial therapy, be over 18, and meet certain health criteria. Those with recent other cancers or serious current infections, among other things, cannot join. The study will check for various outcomes over several months to see how well cema-cel works and note any side effects.

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

TB/LTBI

The purpose of this research study is to assess how your immune system works to protect you from tuberculosis. The parts of the immune system we are studying are called mucosal invariant T cells (MAIT). The study will include 1-2 visits over 15 days with questionnaires and blood samples. Participation in this study does not carry major risks. There are blood draws which can cause some discomfort and may cause bruising. If you agree to take part in this research study, there will not be a direct medical benefit to you. Information learned from this study may help others who have history of active or latent tuberculosis

Rebalance Study May Health

This is a multicenter randomized study testing the May Health System, a device used to treat ovarian tissue through the vagina while guided by ultrasound. The goal is to restore ovulation for women with PCOS-related infertility who did not get results from standard first-line ovulation medicines or who cannot or will not use those medicines. Participants are randomly assigned to have the procedure or to a control group; people in the control group may choose the procedure after the main 3‑month visit. The main measure is whether a woman has at least one ovulation within 3 months. Safety and side effects will be tracked through 36 months. Other measures include ovulation rates to 6 months, time to first ovulation, pregnancies, hormone levels, pain after the procedure, daily activity ability, and procedure times. Eligible women are 18-40, actively trying to conceive, and meet clinical and imaging criteria for PCOS with at least one reachable ovary. The study excludes those who are pregnant, have certain medical conditions (for example serious bleeding disorders, uncontrolled diabetes, very high androgen levels), prior ovarian surgery, or other factors that raise risk or would affect results.

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.

Trastuzumab Deruxtecan Endometrial Study

This global Phase 3 study is testing whether a targeted treatment called trastuzumab deruxtecan (T-DXd) given after surgery can help people with HER2-positive endometrial cancer live longer without the cancer returning. Participants who have newly diagnosed Stage IIC or Stage III endometrial cancer and whose tumors show HER2 will be randomly placed into one of two groups: T-DXd or standard chemotherapy (with or without radiotherapy as decided by the treating doctor). The main goal is to compare the time until cancer returns or the person dies. Doctors will also track overall survival and side effects. T-DXd is a drug that seeks out cancer cells carrying the HER2 protein and delivers a chemotherapy payload directly to them. The study is open-label, which means doctors and patients will know which treatment is given. People will be followed for several years to monitor benefit and safety, including watching for lung inflammation and heart problems, which can be serious with these kinds of treatments.

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

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.

Studying Heat Exposure and Pregnancy Health

This research studies how exposure to hot temperatures during pregnancy may affect a mother's body and pregnancy outcomes. Pregnant women at higher risk for early delivery will wear a smart ring that tracks heart rate, sleep, and body temperature, and will have temperature monitors placed in their homes. Participants will also complete short daily and weekly surveys and provide simple samples like blood, saliva, hair, and nasal swabs. The study follows participants for about three months during pregnancy and briefly after delivery. The goal is to better understand how heat affects pregnancy so future steps can be taken to protect mothers and babies.

Immune profiling of kidney transplant rejection

Researchers are studying why kidney transplant rejection occurs by analyzing blood, urine, and kidney biopsy samples collected during standard clinical care. The goal is to better understand immune activity during rejection and support future improvements in transplant treatment. Participation does not involve experimental treatment.

Understanding Types of Chronic Sinusitis

Adults with chronic sinusitis undergoing sinus surgery may have discarded tissue studied to understand different biological patterns of the disease.

Studying Real-Life Use of Vedolizumab for IBD

This study is looking at how people with inflammatory bowel disease use their vedolizumab treatment and how well a digital tool can help them stay on track. Participants will use an app that reminds them about doses, helps record when they take their medicine, and checks in on their symptoms. The study lasts about six months and does not require extra clinic visits because information is collected electronically. The goal is to learn whether this type of digital support can help people follow their treatment more easily and feel better over time.

OLZ SAM Pediatric Long Term Safety

This is an extension study for children and adolescents who finished or left earlier ALKS 3831 trials. It will give OLZ/SAM (a combination of olanzapine and samidorphan) to patients with schizophrenia or Bipolar I disorder to see how safe and tolerable the medicine is over the long term. Eligible participants must have completed or recently left the prior study, be suitable for outpatient care, have family support, and agree to birth control rules. The main measure is how often adverse events occur over up to 52 weeks of treatment. People with current suicide risk, certain medical problems, prohibited medications, a positive opioid test, or pregnancy are not allowed to join.

Endovascular Treatment in Disabled Stroke

This is a prospective, observational study at multiple stroke centers to compare two commonly used care approaches for people who had moderate-to-severe disability before getting a large-vessel ischemic stroke. One approach is standard medical care (medications, blood pressure and cholesterol control, rehab and other supportive measures) and the other adds endovascular thrombectomy (mechanical removal of the clot). The study will enroll adults with pre-stroke disability (moderate to severe) who arrive within 24 hours of stroke symptoms and have a large artery blockage on brain imaging. The main goal is to compare how patients do at about 90 days after treatment-measuring functional outcome, return to prior level, quality of life, and safety (including death and bleeding in the brain). Results aim to guide care decisions for stroke patients who already had disabilities before their stroke.

Phase I/​ II Trial Combining PD-1 Inhibition and Neoadjuvant Proton or Photon Radiation Therapy in Head and Neck Cancer

This study tests a short course of radiation (either standard X-ray photon radiation or proton radiation) given before surgery together with the immunotherapy drug pembrolizumab for people with recurrent head and neck squamous cell carcinoma. Phase I will enroll small groups to find a safe radiation dose and make sure combining the treatments before surgery is tolerable. Phase II will randomly assign patients to receive either proton or photon radiation plus pembrolizumab before salvage surgery and compare the rate of major pathologic response (very low remaining tumor on the removed tissue) to historical results. About 40 patients will be screened and randomized. Key goals are safety, whether the combination increases major pathologic response, and longer-term outcomes like disease-free and overall survival. The study includes tissue and immune testing to learn how the treatments affect the tumor and microenvironment.

This study may be appropriate for those with: Recurrent Cancer

Evaluating brain injury from subdural hematomas using advanced imaging

We hope to conduct advanced MRIs on patients. We think these MRIs will help better understand how subdural hematomas injure the brain and keep people from fully recovering once the blood goes away.

REGN7508 vs ASA After TKA

This Phase 3 study looks at REGN7508, an experimental drug, compared with aspirin (acetylsalicylic acid) to prevent symptomatic blood clots after elective, one-side total knee replacement in adults. Participants are randomly assigned and neither they nor the study staff know which treatment they receive (double-blind). The main goal is to compare the rate of symptomatic venous thromboembolism (VTE) and VTE-related death up to 30 days after surgery. The study also watches for confirmed deep vein thrombosis (DVT) and pulmonary embolism (PE), time to events, bleeding events, and any side effects up to 90 days. Researchers will measure how much study drug is in the blood over time and check whether participants make antibodies against REGN7508. People with recent major bleeding, certain bleeding disorders, prior clotting disorders, platelet problems, or who received specific pre-op blood thinners are excluded.

Comparing two ways to track red blood cells after a self-donation transfusion

This research looks at a safer, non-radioactive way to track red blood cells after a person donates and receives back a very small amount of their own cells. Volunteers will donate red cells that are stored for 42 days. A small mixed sample is labeled and given back through a vein so we can see how well the cells recover at 24 hours and how long they stay in the body. We compare a vitamin-based label (biotin) to a traditional radioactive label to learn if the vitamin method works as well. Participants will have regular blood draws and safety checks for about 5 months after the small reinfusion. The information could help future blood products be tested without using radioactivity.

CAPTIVA MRI Biomarker Study

This is an observational MRI study done alongside the CAPTIVA clinical trial. People already enrolled in CAPTIVA who had a recent non-disabling stroke from severe narrowing (70-99%) of an intracranial artery can join. Participants get a detailed MRI scan within 14 days of CAPTIVA enrollment to look at artery plaque and blood flow. The study will follow participants for about 12 months to see if MRI features can help predict who will have another ischemic stroke in the same artery despite medical therapy. The goal is to find imaging markers that could guide future trials and improve care for patients with intracranial artery narrowing.

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.

Using Ultrasound to Track Median Nerve Recovery After Carpal Tunnel Release Surgery

Carpal tunnel release is a common surgery for relieving pressure on the median nerve in the wrist. While most patients improve, some continue to have symptoms. This study explores whether ultrasound can help track the healing of the median nerve after surgery and whether changes seen on ultrasound relate to how patients feel and function. Ultrasound is quick, painless, and widely available. Before surgery, patients will have an ultrasound exam that measures the size of the median nerve and blood flow within it. These same measurements will be repeated at later follow‑up visits. Researchers will look at whether the nerve becomes smaller, less swollen, or changes in blood flow as healing occurs. Patients also complete simple questionnaires about hand function, symptoms, and daily activities. Doctors will check strength, sensation, and other routine exam findings. By comparing ultrasound images with patient‑reported outcomes, the study aims to learn whether ultrasound could become an easy way to measure recovery after carpal tunnel surgery. All surgeries, exams, and imaging are part of standard care except for the additional research‑guided ultrasound assessments. The information gained may help future patients and doctors better understand the healing process and identify early signs of improvement or persistent problems.

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

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.

Gene Expression Test for Hidradenitis Suppurativa

Adults with mild hidradenitis suppurativa (HS), folliculitis, or healthy skin will provide a blood sample and skin swab. The goal is to create a lab test that can distinguish HS from similar conditions and understand skin bacteria differences.

How Operating Table Positioning Affects Spine Alignment During Surgery

When patients have spine surgery, they are placed face‑down on special pads that support the chest and pelvis. Small changes in where these pads are positioned may affect the curve and alignment of the spine during surgery. This study aims to find out how much those pad positions matter. Adults having spine surgery with Dr. Zhang may be invited to join. After anesthesia and before surgery begins, three X‑rays of the lower spine and pelvis are taken: one with the pads in the normal position used for surgery, one with the pads shifted slightly upward, and one with the pads shifted slightly downward. Only the normal X‑ray is part of routine care; the other two are performed for the study. After the images are taken, the pads are returned to the normal position and surgery proceeds as planned. Researchers will measure angles in the spine from each X‑ray to see how the position of the pads affects alignment. The goal is to understand whether certain pad placements change the spine's curve and whether these changes could impact surgical planning or outcomes. The study does not change the surgery itself and involves only minimal extra time and two additional X‑rays. All other aspects of care are standard. The information gathered may help surgeons position patients more precisely in the future and improve alignment during spine surgery.

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.

Comparing Two Stemless Shoulder Replacement Implants to Improve Function and Patient Outcomes

This study compares two different stemless shoulder replacement implants-the Nano and Sidus components-to learn whether one offers better function, comfort, or recovery for patients needing an anatomic total shoulder arthroplasty (TSA). Both implants are FDA‑approved and routinely used by the surgeon, and the surgery itself follows standard medical practice. Adult patients who are recommended for TSA by Dr. Grawe may be invited to participate. After giving consent, they complete a few short questionnaires about shoulder function and general health, and their range of motion is measured. They are then randomly assigned to receive either the Nano or the Sidus implant. Randomization ensures a fair comparison between the two options. The shoulder replacement surgery is performed in the usual way, with the only difference being the specific stemless implant used. After surgery, patients return for checkups at approximately 6 months, 12 months, and 24 months. At each visit, they complete the same questionnaires and have X‑rays and range of motion testing to evaluate healing and progress. The goal of this research is to determine whether one implant provides better outcomes than the other and to help surgeons choose the best option for future patients. There are no additional procedures, costs, or risks beyond standard care, and both implants represent established shoulder replacement options already widely used in clinical practice.

A Study of DB-1311 in Advanced/​Metastatic Solid Tumors

This Phase 1/2a trial aims to assess the safety and tolerability of DB-1311 in patients with advanced solid tumors through dose-escalation and dose-expansion studies.

This study may be appropriate for those with: Metastatic Cancer

Dystonia Coalition Projects-3

The overall mission of the Dystonia Coalition is to develop a better understanding of the dystonias so that we may improve treatment. Presently, there are four related projects; the first three projects are grouped together because they are related. The last project will be open only to selected participants as an option. 1. Natural History (NH) Project: The aim of this observational project is to better characterize the heterogeneity of clinical manifestations among subjects with dystonia, how these manifestations evolve over time, and how they relate to other family members. A fuller understanding of clinical features and especially their evolution over time is an essential prerequisite for testing any potential disease-modifying therapies that could alter the course of the disorder. 2. Objective Measures (OM) Project: The aim of this project is to exploit technological advances for development of objective tools to measure the severity of dystonia. Current diagnostic and severity measures depend almost entirely on subjective clinician-rated or patient-rated scales. New technology could ultimately replace these subjective scales as outcome measures. They could also be used for telemedicine. This study is not interventional, but instead relies on video recordings or motion sensors that can non-invasively detect movements. 3. Biobank (BB) Project: The aim of this project is to develop a resource that expands the existing dystonia DNA biorepository to include other biomaterials. To date, no large multicenter open-access biorepository exists for any type of dystonia. Such a biobank is essential for improving our understanding of the pathogenesis of the dystonias, so that rational therapies can be planned. It also is essential for exploration of biomarkers of disease activity that may provide useful outcome measures in clinical trials, or insights into pathogenesis. This study also is not interventional. 4. Patient-Centered Outcomes (PCO) Project: The aim of this project is to delineate both between-subject and within-subject variations over time in response to the standard of care treatment with Botulinum toxin (BoNT) injections. Typically, injections are required about every 3 months. Therapeutic benefits emerge within the first week and then wear off after 8-16 weeks, creating a cyclical response known as the "yo-yo" effect. The development of any novel "add-on" therapeutics or replacement therapeutic is hampered by incomplete knowledge of individual temporal responses. Currently, measurement tools rely on clinical rating scales which are subjective, cumbersome for repeated frequent use, and require extensive expertise to apply. This project will develop a patient-facing tool on a hand-held electronic device, such as a smartphone. This is not an interventional study; it aims to collect data regarding responses to routine clinical treatments.

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.

Patterns in Chronic Sinusitis After Surgery

Adults having sinus surgery may join this study, which compares disease patterns across different groups. Participation involves data collection around routine care.

Testing Venetoclax for Relapsed Hairy Cell Leukemia

This study is investigating the effectiveness of the drug venetoclax in patients whose hairy cell leukemia has returned after initial treatment. Venetoclax works by blocking a protein necessary for cancer cell survival, potentially reducing cancer growth. Participants will take venetoclax daily in cycles, and their response will be monitored through medical tests, including blood samples and imaging scans. The study aims to measure the overall response rate, complete remission, and any side effects. Eligible participants are those who have not had prior venetoclax treatment and meet specific health criteria. People with certain conditions or allergies should not participate. The study will follow participants for 30 days after their last medication dose to assess outcomes.

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

DeciPHer ILD Patient Registry

This is a multi-center, non-interventional registry that will follow people who have pulmonary hypertension caused by interstitial lung disease. About 1,000 patients will join one of three groups: not using inhaled treprostinil, newly started on Tyvaso or Tyvaso DPI, or on Tyvaso/Tyvaso DPI for more than 60 days. Participants will have tests and questionnaires done at enrollment and then every 6 or 12 months, using results already recorded when available. The study will collect lung tests and scans, walking test results, blood tests, heart imaging, quality of life surveys, medication and rehab details, healthcare use, transplant and survival information, and other clinical data. Patients will be followed for up to five years to learn more about patient characteristics, treatment patterns, and outcomes in real-world care.

ARS2 Treatment for Chronic Urticaria

This is a Phase 2b outpatient study that tests a single dose of ARS-2 against placebo in adults with chronic spontaneous urticaria (recurrent hives). The study is randomized, double-blind, placebo-controlled, and uses a three-period crossover design. After screening, each participant will receive three blinded treatment periods (each a single dose) so they serve as their own comparison. Participants must have a history of moderate to severe flares while on chronic treatment and will use a smartphone app to report symptoms and any side effects. The main goal is to compare change in itch and hive scores during flares after ARS-2 (0.5 mg or 1 mg) versus placebo over the study period.

DB 1311 Combination Trial

This is an open-label Phase 2 study testing DB-1311 given with either BNT327 or DB-1305 in people with advanced or metastatic solid tumors that have not responded to prior treatments. The study aims to check safety, side effects, how the body processes the drugs, and early signs of benefit like tumor shrinkage and longer time without disease growth. Eligible participants have one of several cancer types (liver cancer, cervical cancer, melanoma, head and neck cancer, platinum-resistant ovarian cancer, or non-small cell lung cancer) and meet basic health and lab criteria. People who previously received certain similar antibody-drug treatments, have serious uncontrolled illnesses, active brain metastases, autoimmune disease, or unresolved severe side effects are not allowed. Participants will receive study drugs in repeated treatment cycles and be seen regularly for safety checks, scans, and blood tests. The study may follow participants for up to about 6 years to collect long-term safety and outcome data.

This study may be appropriate for those with: Metastatic Cancer

New Treatments for Recurrent Glioblastoma

This clinical trial studies new drug combinations for treating people with recurrent glioblastoma, a type of brain cancer that has returned. The trial is testing whether the combination of two monoclonal antibodies, relatlimab and nivolumab, can be as effective or more effective than the current standard treatment, lomustine. These drugs work by potentially interfering with the ability of tumor cells to grow and spread. Participants will be randomly assigned to receive either the experimental drug combination or the standard chemotherapy drug. They will undergo regular checks, including MRI scans and biopsies, to track their response to treatment. The study will compare survival times and patient health outcomes between the two treatment groups over various periods up to 5 years to understand the effectiveness and safety of these treatments.

This study may be appropriate for those with: Recurrent Cancer

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.

Ublituximab Modified Regimen Study

This Phase 3b study tests a changed dosing plan of ublituximab, a medicine that targets B cells, in people with relapsing multiple sclerosis (RMS). The study has three parts: Part A is open to eligible participants and looks at MRI brain lesions over about 48 weeks; Part B is randomized and double-blind to study drug levels and compare to placebo up to 16 weeks; Part C enrolls people who had a suboptimal experience on another anti-CD20 treatment to see how they do on ublituximab. Main goals are to see if the modified schedule prevents new gadolinium-enhancing MRI lesions and to understand the drug's blood levels. Participants have regular visits for dosing, safety checks, and MRI scans. People with active infections, certain immune diseases, prior serious infusion reactions to anti-CD20 drugs, some prior cancer or prior use of specific immunosuppressive drugs are not allowed to join.

Understanding how people with chronic sinus disease describe flare-ups and control

This study aims to better understand how people with chronic sinus problems think about when their symptoms are "under control" and what they consider a flare-up. Adults with chronic sinus disease will be asked to share their experiences during interviews, either by phone, video, or in clinic. Researchers will look for common themes in these conversations to help create clearer, patient-centered ways for doctors and patients to talk about symptoms and treatment success. Participation involves interviews only and does not change medical care.

Vorasidenib with Temozolomide Trial

This Phase 3 clinical trial tests whether adding vorasidenib to the usual post‑radiation chemotherapy (temozolomide) helps people with newly diagnosed IDH‑mutant grade 3 astrocytoma. Patients are randomly assigned to one of two groups: both get standard radiation followed by temozolomide tablets, and one group also gets vorasidenib tablets while the other gets a placebo. Treatment cycles are 28 days, with the study drug taken daily and temozolomide given on days 1-5 of each cycle, for up to 12 months if the disease does not get worse and side effects are acceptable. Doctors will check tumor status with regular MRI scans and blood tests. The main goal is to see whether adding vorasidenib delays tumor growth (progression‑free survival). The study also looks at safety, overall survival, tumor response, time to next treatment, seizure control, and quality of life. After finishing study drugs, participants are followed for several years to monitor long‑term outcomes.

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

Iloperidone Adolescents Safety Study

This is an open-label, single-group Phase 4 study testing iloperidone (FANAPT) in adolescents aged 12-17 who have schizophrenia or bipolar I disorder. Participants may receive iloperidone at doses between 8 and 24 mg per day for up to 52 weeks. The main goal is to evaluate safety and tolerability by recording treatment-emergent adverse events over the treatment period. To join, a young person must be willing to give assent and have a parent or guardian provide consent. People currently using another investigational drug or who test positive for drugs of abuse are not eligible. The study is intended to collect longer-term safety information for adolescent patients on iloperidone.

PPMI

The Parkinson Progression Marker Initiative 2.0 (PPMI 2.0) is a longitudinal, observational, multi-center natural history study to assess progression of clinical features, digital outcomes, and imaging, biologic and genetic markers of Parkinson's disease (PD) progression in study participants with manifest PD, prodromal PD, and healthy controls. The overall goal of PPMI 2.0 is to identify markers of disease progression for use in clinical trials of therapies to reduce progression of PD disability.

Early Pelvic Floor Therapy Study

This is a small single group study of 28 women with invasive cervical cancer who will get pelvic external beam radiation as part of their treatment. About four weeks after finishing radiation, participants will begin pelvic floor physical therapy. The study will measure how many women have fecal incontinence three months after radiation using a standard patient survey (EORTC QLQ CX24). A survey score of 1 or higher will count as incontinence. The study will also look at urinary incontinence, sexual symptoms, overall quality of life, how well participants follow recommended dilator use, and changes in pelvic floor muscle function (measured with the Brink scale). Assessments will be done before therapy and at three months after radiation. The goal is to see how common bowel leakage is after pelvic radiation and whether early pelvic floor therapy can be studied further as a supportive care approach.

Efficacy and Safety of Trimodulin in Severe Pneumonia Patients

This study is exploring the effectiveness and safety of a drug called trimodulin in treating adults with severe community-acquired pneumonia who are on ventilators. Participants will receive either trimodulin or a placebo, along with standard medical care. The main goal is to see if trimodulin can reduce death rates and improve recovery. The trial will monitor subjects closely over 29 days, with an additional follow-up until day 91 to check long-term effects, safety, and overall health improvements. The study also involves collecting detailed data on how trimodulin is processed in the body, aiming to improve current treatments for this serious illness.

APT Acute TBI Adaptive Multi-Arm Phase 2 Platform Trial

This is a randomized, parallel, multi-arm, multi-stage adaptive Phase 2 platform trial testing whether repurposed FDA-approved drugs given off-label soon after injury can improve recovery after acute non-penetrating traumatic brain injury (TBI). Adults 18-65 who present within 24 hours of injury with a Glasgow Coma Scale (GCS) 9-15, CT evidence of intracranial trauma (CT+), and an elevated GFAP blood level (>100 pg/mL) are eligible. Participants are randomized to one of the investigational drug arms or placebo. Investigational agents vary by arm and are selected for potential neuroprotective and anti-inflammatory effects to reduce secondary injury. Participants undergo serial clinical assessments, blood biomarker sampling (including GFAP and NfL), cognitive testing, and MRI (including DTI). The primary efficacy outcome compares change in the Glasgow Outcome Scale-Extended (GOSE) between Week 2 and Month 3. Secondary outcomes include biomarker trajectories, DTI measures, cognitive performance, and post-concussive symptom scales. Follow-up visits occur through Month 6 with approximately six in-person visits plus interim phone assessments and scheduled imaging/blood draws. Safety monitoring excludes participants with significant comorbidities, pregnancy, known contraindications to study drugs, or abnormal renal/hepatic function, among other criteria. The trial uses an adaptive platform design allowing multiple investigational arms to be evaluated sequentially or concurrently against placebo.

Hormone Therapy for Menopause in HIV

This study will test menopausal hormone therapy in women living with HIV who are in late menopause transition or early after menopause and who have bothersome hot flashes or night sweats. After a short observation period to record symptoms, participants will be randomly assigned to receive hormone therapy (estradiol with or without progesterone, as appropriate) and followed for 12 weeks. The study will look at whether hormones lower the number and severity of hot flashes and night sweats, and whether they help sleep, mood, thinking, sexual function, and overall quality of life. Researchers will also monitor effects on weight and body measurements, markers of bone and heart health and inflammation, and any side effects or safety problems, including abnormal vaginal bleeding. The goal is to find out if menopausal hormone therapy is effective and safe for women with HIV who have menopausal symptoms.

Finerenone in Kidney Transplants

This study will test a medicine called finerenone in people who have had a kidney transplant. The trial will enroll 150 transplant recipients and will compare finerenone to a placebo in a double-blind, randomized design over about 13 months. The team will check whether it is possible to recruit transplant patients and whether they will accept extra tests like research kidney biopsies and special kidney MRIs. The study will also look at safety and tolerability, especially the risk of high potassium and changes in kidney function. Researchers will measure urine protein, kidney function over time, heart failure events needing care, changes seen on kidney MRI, and changes seen on biopsy tissue in the biopsy subgroup. Results will help decide if larger trials are needed.

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.

Testing the Use of Chemotherapy After Surgery for High-Risk Pancreatic Neuroendocrine Tumors

This phase II trial studies the effect of capecitabine and temozolomide after surgery in treating patients with high-risk well-differentiated pancreatic neuroendocrine tumors. Chemotherapy drugs, such as capecitabine and temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving capecitabine and temozolomide after surgery could prevent or delay the return of cancer in patients with high-risk well-differentiated pancreatic neuroendocrine tumors.

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

LIBREXIA: Milvexian for Stroke Prevention

This is a Phase 3, randomized, double-blind study testing whether milvexian, an oral medicine that blocks Factor XIa, can prevent repeat ischemic strokes in people who recently had an acute ischemic stroke or a high-risk transient ischemic attack (TIA). Adults who meet the entry rules and can start treatment within 48 hours of their event are randomly assigned to take milvexian or a matching placebo while continuing standard antiplatelet care. The main measure is time until the first new ischemic stroke, tracked for up to about 41 months. The study also looks at broader cardiovascular outcomes and safety, especially bleeding and liver effects. The goal is to see if milvexian reduces recurrent strokes without causing unacceptable side effects.

Study on New Treatment for Recurrent Ovarian Cancer

This study is looking at how effective and safe a new drug called sacituzumab tirumotecan, alone or with another drug called bevacizumab, is compared to the usual treatments for people whose ovarian cancer has come back after responding well to platinum-based chemotherapy. The study hopes to find out if patients can live longer without their cancer getting worse with this new treatment and if it's tolerable and safe. They will measure how patients respond to the treatment and monitor any side effects. The trial is in its third phase and will take place over four years.

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

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.

Study of Sapanisertib and Serabelisib with Paclitaxel for Endometrial Cancer

This clinical trial aims to test a new treatment combining sapanisertib, serabelisib, and paclitaxel for patients with advanced or recurrent endometrial cancer. This study specifically looks at participants who have undergone previous cancer treatments, such as platinum-based chemotherapy and immune checkpoint inhibitors, without success. The treatment is intended for patients who cannot be helped with surgery or radiation. To join, participants need to show specific genetic alterations related to cancer growth. The trial will measure how well the cancer responds to treatment using these medications and will check for any side effects. It's open to women who are postmenopausal or agree to use contraceptives. Participants will be monitored over several years to assess how their cancer progresses and their overall survival. However, those with other recent cancers or certain medical conditions affecting drug absorption or interaction are not eligible.

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

Alzheimer's National Registry for Treatment and Diagnostics

The ALZ-NET study is establishing a national registry to collect ongoing clinical and safety information for patients being evaluated for or treated with new FDA-approved therapies for Alzheimer's disease. This effort will help track how well these treatments work over time and their safety outcomes in everyday medical settings. Participating doctors and staff will receive training to ensure accurate data collection. By gathering a wide range of information, including cognitive and safety data as well as genetic and imaging biomarkers, ALZ-NET aims to improve care and support innovative research. They also plan to store biological samples and brain images from consenting participants. The study is open to adults 18 and older who are either considering, starting, or currently on new Alzheimer's treatments.

FASTER-HIP: Studying the Best Surgery for Certain Hip Fractures

FASTER-HIP is a research study comparing two common surgeries for certain hip fractures in older adults. The goal is to find out which surgery leads to better recovery, fewer complications, and helps patients stay active and independent.

Effect of a Virtual Reality Cognitive Training Intervention for Brain Cancer Survivors

You will either be assigned to a group that uses the virtual reality training system or a group that will complete paper word search puzzles. At the start of the study all participants will be asked to complete three short cognitive tests to check your current memory and thinking skills. You will take the same tests again at the end of the study to see if anything has changed or improved. You will receive a schedule based on your start and end dates that explains which days you will need to complete the study-related tasks. You will complete the tasks at home for 4 weeks, 6 days a week. It will start at 15 minutes a day in week one and increase by 5 minutes each week, ending at 30 minutes a day in week four. You will receive either a VR headset and hand controllers for use with VR-CRT (and portable WI-FI hotspot if you do not have WI-FI at home) or a notebook for use with paper word-search puzzles (WSP). The research study will provide the technology to you free of charge, but with a technology sign-out consent to confirm your agreement to return the VR and WI-FI equipment once the study is completed. If you are in the VR group, you will be trained on how to use the equipment and how to connect the VR equipment to WIFI. Off-the-shelf VR equipment (Meta Quest 3/128 GB with WIFI) will be used.

Testing a New Combo Therapy for Relapsed Aggressive B-cell Lymphoma

This trial studies how well a combination of drugs called ViPOR works for patients with a type of aggressive lymphoma that has returned after treatment or not responded to previous treatments. ViPOR combines 5 drugs: venetoclax, ibrutinib, prednisone, obinutuzumab, and Revlimid. Each has its own function, but together they aim to stop cancer cells from growing by targeting specific proteins and supporting the immune system's ability to attack these cancer cells. This research will see whether this drug mix can help the patient's lymphoma disappear fully and track patients' survival over time. Participants will receive these medicines in cycles every 21 days for up to 6 cycles and might have tests like blood tests and scans along the way. The study checks if this treatment stops the lymphoma from growing and how safe it is.

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

Global HDFN Prospective Registry

This is a non-interventional registry that follows pregnant people who are at risk for hemolytic disease of the fetus and newborn (HDFN). The study will collect health information from routine prenatal care, delivery, and newborn care to find out how often babies develop anemia or other HDFN problems, how severe those problems are, and what treatments are used. Eligible participants are pregnant up to 24 weeks, have a history of an affected pregnancy, have antibodies in the current pregnancy, and have evidence the fetus carries the corresponding blood antigen. The study does not change medical care; it records what happens during standard care from pregnancy through the newborn period (generally up to about 4 weeks after birth).

Study on Anifrolumab for Treating Systemic Sclerosis

This study is testing a medicine called anifrolumab to see if it helps people with a disease called systemic sclerosis, which can also be known as scleroderma. This disease causes hardening and tightening of the skin and sometimes affects internal organs. The study is being run by AstraZeneca and is currently looking for participants. The study involves adults between the ages of 18 and 70 who have been diagnosed with systemic sclerosis according to specific criteria. The participants should have had the disease for less than 6 years. People who join the study will be randomly divided into two groups. One group will get anifrolumab and the other will get a placebo, which is a substance with no active medication. This will happen for the first 52 weeks. After that, everyone in the study will receive anifrolumab for another 52 weeks. During the study, there will be regular check-ups and visits to the clinic. Participants will either get the medicine through injections at the clinic or they can do it at home. The study will look at how well the medicine works and its safety. Researchers will measure different outcomes, like changes in skin thickness and lung function, and check for any side effects. To be part of the study, participants need to meet certain conditions, like having a specific level of disease activity. There are also some reasons why people might not be able to join, such as having other serious health problems or a history of certain conditions. Overall, the goal is to find out if anifrolumab can make a positive difference for people living with systemic sclerosis, improving their symptoms and overall health.

A Phase 3 Single-arm Study of UGN-104 for the Treatment of Low-grade Upper Tract Urothelial Cancer

This clinical trial examines the effectiveness and safety of a new drug, UGN-104, for patients with low-grade upper tract urothelial cancer. During the study, UGN-104 is administered directly into the upper urinary tract once a week for six weeks. Patients who show no signs of cancer after these treatments will have follow-up visits and may continue receiving monthly doses as a maintenance treatment plan for up to one year. These maintenance visits help ensure that the cancer does not return. The study involves regular check-ups every three months and lasts up to 15 months. Participants must have been diagnosed with this type of cancer and should not have received certain other treatments or have specific health conditions.

This study may be appropriate for those with: Recurrent Cancer

Studying brain signals and thinking

This study measures brain signals while people perform computer-based thinking and memory tasks. Some participants also receive gentle electrical stimulation to see how it affects brain activity.

Cretostimogene in High Risk NMIBC

This Phase 2 study tests a virus based drug called cretostimogene grenadenorepvec given directly into the bladder to treat high risk non muscle invasive bladder cancer. The study has several groups: patients who never had BCG vaccine treatment, those who previously had BCG, and a group that is BCG unresponsive or exposed. Some patients are randomly assigned to different ways of putting the drug into the bladder, and one group will get the drug with the chemotherapy drug gemcitabine either at the same time or one after the other. Treatment starts with a weekly induction for 6 weeks. If needed, a reinduction is given at 3 months. If high grade cancer is gone, maintenance treatments follow: three weekly treatments every 3 months in year 1, then every 6 months in year 2, with an optional extension into year 3. Doctors check disease with urine tests and bladder exams every 3 months for 2 years, then every 6 months for up to 4 years total or until the cancer returns. The study looks at response rates, how long patients stay free of high grade events, and safety.

This study may be appropriate for those with: Metastatic Cancer

StrokeNet Thrombectomy Platform

STEP is a large, multi-center study testing ways to improve care for people who have an acute ischemic stroke caused by a blockage in a large or medium brain artery. The trial runs at many stroke centers and is set up so new treatments can be added over time. It studies several types of approaches: broadening who might get endovascular thrombectomy (a clot-removal procedure), testing new devices used during clot removal, testing medicines given along with the procedure, and testing early or pre-hospital tools and systems to speed care. People are randomly assigned to treatments so researchers can compare results. The main goal is to see which options help people have less disability 90 days after their stroke, while watching for harms like bleeding or death. The study adapts as results come in, so it can stop or expand parts that look better or worse.

Study of Biomarkers in Neurodegenerative Diseases

The purpose of this study is to assess the extent to which genetic and biological/molecular abnormalities may affect different patterns of symptoms within neurodegenerative conditions, namely PD/PD-like and AD/AD-like diseases. Patients will be followed annually after a comprehensive baseline visit.

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

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.

Understanding Inflammation During Pregnancy and Preterm Birth

This study aims to learn how inflammation during pregnancy affects both mothers and babies, especially when a baby is born early. Researchers will collect blood and tissue samples after birth. These samples help scientists understand how conditions like infection or inflammation inside the uterus may lead to early labor or health problems for newborns. Participation does not change medical care and involves no follow-up. The information collected may help improve future care for pregnant people and babies.

Cemiplimab CDX-1140 Before Surgery

This is a randomized phase 2 study for adults with stage III or IV head and neck squamous cell cancer who are scheduled for surgery. Patients are placed into one of two groups. One group receives cemiplimab (an anti PD‑1 immunotherapy) before surgery. The other group receives one dose of the anti‑CD40 drug CDX‑1140 followed a few days later by cemiplimab before surgery. Surgery is planned about 4 to 5 weeks after treatment. After surgery patients receive standard care as needed and are followed for up to two years. The main goal is to compare how often the removed tumor shows a major pathologic response (very little viable cancer left) between the two groups. The study also checks safety and side effects, looks at tumor and blood markers (including gene expression and circulating tumor DNA), studies immune changes in the tumor, and measures drug levels. Visits include screening tests, treatment infusions, the surgery visit, and follow up visits at about weeks 9–10 and 18, at 6 months, and then every 3–6 months for two years.

This study may be appropriate for those with: Metastatic Cancer

Tasimelteon for Pediatric Insomnia

This is a multicenter, double-blind, randomized Phase 3 study testing a once-daily oral dose of tasimelteon against a matching placebo in children and teens (ages 2 to 17) with insomnia disorder. Participants will be randomly assigned to tasimelteon or placebo and treated for about 12 weeks. The study looks at time to fall asleep and other sleep measures recorded in sleep diaries and with actigraphy, plus daytime functioning and behavior via questionnaires. Safety and tolerability will be monitored by recording any adverse events.

Study on TL-895 for Indolent Systemic Mastocytosis

This clinical study is testing a drug called TL-895, used to treat conditions called Indolent Systemic Mastocytosis. It's designed for adults who have tried other treatments which didn't work or who can't take certain medications, like JAK inhibitors. Participants must have certain symptoms and body functions to qualify. The study aims to find the best dose and see if the drug helps reduce symptoms and spleen size. It includes taking TL-895 orally and involves regular checkups to monitor progress.

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

Understanding Chronic Sinusitis Symptoms

This study interviews adults with chronic sinus problems to understand how they recognize flare-ups and symptom control. The goal is to improve future symptom tracking and care.

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

Etrasimod in Moderate Ulcerative Colitis

This is a 52-week observational study (plus a 28-day safety follow-up) that will collect real-world information on how etrasimod works for adults with moderately to severely active ulcerative colitis when prescribed by their doctor. Patients will receive etrasimod as part of routine care and complete symptom and quality-of-life questionnaires on their phone, tablet, or computer at set timepoints. The study compares each patient's symptoms after starting etrasimod to their baseline before treatment. Key outcomes include rates of symptomatic and clinical remission and response, steroid-free remission, changes in fatigue, bowel urgency, and abdominal pain, assessed at weeks 12, 24, 36, and 52. Safety information will be recorded per usual care. Patients must be 18-64, have confirmed UC, be starting etrasimod, and be able to use the electronic questionnaires. People with signs of Crohn's disease, very severe UC needing imminent hospitalization or surgery, prior etrasimod use, certain concurrent UC medications, inability to use the web tool, or study staff/family relations are excluded.

Does latent TB infection raise the risk of diabetes or heart disease?

This research looks at whether having a silent TB infection can increase the chance of developing diabetes or heart problems. Adults with and without latent TB infection will have health checks, blood tests, and simple vessel tests at the start, 6 months, and 24 months. The visit takes about 1-3 hours. The study does not give TB treatment, but test results like cholesterol, A1c, insulin, fasting glucose, and TB blood tests will be shared through the patient portal so people can discuss them with their regular doctor. There may be brief phone check-ins between visits to help with scheduling. There is no direct medical benefit from joining, but what we learn could help improve care for people with a history of TB exposure.

Cannabidiol for Focal Seizures Study

This is an open-label, single-group study testing a cannabidiol (CBD) oral solution as an extra medicine for people with focal-onset seizures aged 12 to 75. Participants will keep their current anti-seizure medicines (1 to 4 drugs) and add the CBD solution. The main goal is to see whether CBD lowers the number of focal seizures compared to each person's baseline over about 16 weeks. The study will also look at safety, how the body handles the drug (pharmacokinetics), and whether brain imaging (fMRI) or thinking tests predict who responds best. Some people in the study may be early in their treatment and others may have hard-to-treat seizures. The study does not include people with non-epileptic events, recent CBD or cannabis use, certain allergies, or unstable medical or mental-health issues.

Ruxolitinib Cream for Hidradenitis

This is a Phase 3, randomized, double-blind study that tests ruxolitinib cream against a matching vehicle (placebo) cream in people with mild to moderate hidradenitis suppurativa (HS). Participants must have had HS for at least 6 months, have disease in two or more areas, at least four abscesses or inflammatory nodules, and no draining tunnels. The main goal is to see how many people reach HiSCR75 (a 75% or greater drop in abscesses and nodules with no increase in abscesses or draining tunnels) by Week 16. The study also tracks flares, skin pain, itch, quality of life measures, and safety over the treatment period and into an extension period lasting up to about one year. People who previously did not respond to or could not take certain HS treatments are also evaluated in a separate subgroup. Safety is monitored by recording any treatment-emergent adverse events throughout the study.

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

Understanding Sinus Inflammation

Adults having sinus surgery may provide samples to help researchers understand inflammation and improve treatments.

Study of JZP898 for Advanced/Metastatic Solid Tumors

This clinical research study is focused on understanding how a new drug called JZP898 works in adults who have advanced or metastatic solid tumors. The study is taking place in two parts. In the first part, researchers are exploring how the drug works on its own and when combined with another drug, pembrolizumab. They aim to find a safe dosage and look for any potential side effects. In the second part, they will further explore the effects of the combination of these two drugs on different types of tumors. The researchers want to know if these treatments can shrink the tumors and are safe for people to use over a long time. They will keep track of how the participants react to the treatment and measure things like how long the drug stays in their system and if it has any unwanted effects. People who want to participate must meet certain conditions, like having a specific kind of tumor and being able to care for themselves daily without too much help. This study is supported by Jazz Pharmaceuticals.

This study may be appropriate for those with: Metastatic Cancer

Study on ABBV-383 for Relapsed or Refractory Multiple Myeloma

This study focuses on testing the safety and dose optimization of a new drug, ABBV-383, for adults with relapsed or refractory multiple myeloma, a type of blood cancer. Researchers are trying to find the best way to use this drug by looking at different dose levels. They will monitor participants for adverse effects like cytokine release syndrome, which can cause symptoms like fever and low blood pressure. The study includes three groups, each with different dosing plans. Around 180 participants will be treated with ABBV-383 as an IV infusion every 28 days for about three years. Throughout the study, participants will undergo medical checks and fill out questionnaires to track their health and any side effects.

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

XTMAB16 Pulmonary Sarcoidosis

This is a Phase 1b/2 clinical trial testing XTMAB-16, an experimental antibody, in adults with pulmonary sarcoidosis who are on low to moderate daily prednisone. The study is randomized and uses a sequential multiple-dose design. Main goals are to assess safety and how well patients tolerate the drug, and to see whether XTMAB-16 helps people reduce their steroid dose. The study has two parts: Part A (shorter, about 20 weeks) focuses on safety and initial efficacy signals, and Part B (longer, about 34 weeks) evaluates maintaining steroid reduction. Key measures include the rate of side effects and how many participants can lower or cut their steroid dose by predefined amounts. Participants must meet specific health and lab criteria and cannot have certain infections, recent use of other biologic drugs, major organ dysfunction, or conditions like pregnancy that could complicate treatment.

Understanding How People with Heart Conditions Take Their Medications

This study is trying to understand how people with heart conditions manage taking their prescribed medications. Researchers want to learn about real-life experiences, including what makes it easier or harder to take medications regularly. Participants will complete one interview lasting up to about an hour, either in person, by phone, or online. There are minimal risks, such as feeling tired or uncomfortable answering questions. While there may not be direct benefits, the findings could help improve future care and support for people with heart conditions.

Monitoring in Breast Cancer- ctDNA

This study follows people with breast cancer over time to see whether tiny amounts of cancer DNA in the blood (called circulating tumor DNA or ctDNA) can show if cancer remains after treatment and predict if it will come back. Participants give blood samples at different times: during pre-surgery treatment, after surgery, during routine follow-up, and up to long-term monitoring. The study includes patients receiving pre-surgery treatment, those who have completed surgery and have no visible disease, and people who have been disease-free for five years but were originally at higher risk. Researchers will use DNA sequencing of the blood to look for signs of minimal residual disease (MRD). The main goal is to compare disease-free survival between people with and without detectable ctDNA. Secondary goals examine distant recurrence, overall survival, how MRD relates to tumor response after surgery, and how long it takes from a first positive ctDNA test to clinical recurrence. The study is observational - it only collects samples and clinical information - and aims to improve early detection of recurrence and help guide future tests and treatments.

CSL300 for cardiovascular outcomes ESKD

NOT YET OPEN TO RECRUITMENT Study Aims to assess the efficacy of CSL300 on CV outcomes and safety in subjects with ASCVD or diabetes mellitus and evidence of systemic inflammation who are undergoing maintenance dialysis. Medication is an IL-6 MAb. Dialysis patient will receive drug or placebo every 4weeks at dialysis clinic. Outcomes study expected to last 5 years.

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

Study of ZE50-0134 for Chronic Lymphocytic Leukemia and Lymphomas

This clinical trial is mainly for adults who have a type of blood cancer known as Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Lymphoma (SLL), as well as some other related low-grade lymphomas. The study aims to test a new treatment called ZE50-0134. It's designed to see how safe the medicine is, how it moves through the body, and how well it works against these illnesses. In the first part of the study, doctors will try different doses to find the highest amount patients can handle safely. In the second part, they will explore how effective this dose is and confirm safety with a focus on long-term usage. Patients will participate in multiple cycles of treatment, each cycle lasting four weeks, up to a total of 24 cycles, but detailed visits depend on patient grouping and specific needs. This trial is open label, meaning patients will know they are receiving ZE50-0134. Participants must be at least 18 years old and have already tried some other treatments unsuccessfully. They shouldn't have certain health issues like active infection, severe heart problems, or recent surgery. Pregnancy testing is required for women of childbearing potential before starting the drug.

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

Weight Changes After Jaw Surgery

This research study is looking at how people's weight changes after jaw surgery. Doctors know that some people lose weight while they recover, but it is not clear how much weight is usually lost or whether it depends on the type of surgery or the recommended diet after surgery. People who are already planning to have jaw surgery may be asked to join. If they choose to participate, their weight will be recorded before surgery and during routine follow-up visits over about six weeks. The study does not change medical care, surgery, or recovery. There is no direct benefit to participants, but the information may help improve care for future patients.

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

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.

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

Early Neuromodulation TBI Recovery

This study tests whether a short, noninvasive brain stimulation given early after a moderate to severe traumatic brain injury (TBI) helps thinking and memory as the brain heals. The study will enroll about 60 adults who had an isolated moderate or severe TBI. At the first (acute) visit while still in the hospital, participants complete a short thinking test and two computer tasks while their brain waves are recorded with EEG. Half will be randomly chosen to get 15 minutes of active anodal transcranial electrical stimulation (A-tES) to the left front part of the brain while doing the tasks; the other half will get a sham (placebo) stimulation. Everyone is followed for 6 months. At about 3 months they return for testing and all receive active A-tES during tasks. At 6 months they do testing with EEG but no stimulation. The study aims to (1) find brainwave patterns that track recovery from acute to chronic stages of TBI and (2) test whether giving A-tES early improves task performance, cognitive test scores, and quality of life at 6 months compared with giving stimulation only at 3 months. The study uses a randomized, double-blind, sham-controlled design for the early stimulation comparison.

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.

CA-4948 Added to Standard Chemotherapy to Treat Metastatic or Unresectable Pancreatic Cancer

The usual approach for patients with pancreatic ductal adenocarcinoma is treatment with chemotherapy drugs gemcitabine and nab-paclitaxel. Gemcitabine is a chemotherapy drug that blocks the cells from making DNA and may kill cancer cells. Paclitaxel is in a class of medications called anti-microtubule agents. It stops cancer cells from growing and dividing and may kill them. Nab-paclitaxel is an albumin-stabilized nanoparticle formulation of paclitaxel which may have fewer side effects and work better than other forms of paclitaxel. Giving CA-4948 in combination with gemcitabine and nab-paclitaxel may shrink or stabilize metastatic or unresectable pancreatic ductal adenocarcinoma.

This study may be appropriate for those with: Metastatic Cancer

Phase III Study of Ivonescimab or Bevacizumab Combined With FOLFOX in Patients With Metastatic Colorectal Cancer

The main purpose of this study is to measure the safety and effectiveness with ivonescimab/SMT112 in combination with chemotherapy drugs, i.e., FOLFOX (Oxaliplatin, Leucovorin and Fluorouracil) in the first-line treatment of metastatic colorectal cancer (mCRC) compared to bevacizumab in combination with chemotherapy drugs, i.e., FOLFOX (Oxaliplatin, Leucovorin and 5-Fluorouracil). Ivonescimab/SMT112 is considered investigational and has not been approved by the U.S. Food & Drug Administration/local Regulatory Authority for treatment or sale. Bevacizumab is a different approved drug sold under the brand name Avastin. FOLFOX is a standard chemotherapy regimen made up of the drugs folinic acid (leucovorin, FOL), fluorouracil (5-FU, F), and oxaliplatin (Eloxatin, OX).

This study may be appropriate for those with: Metastatic Cancer

ATHN Transcends - Observational study for people with bleeding disorders

This is a long-term, observational study enrolling up to about 3,000 people at roughly 150 ATHN-affiliated sites. Participants join one cohort based on their condition (Hemophilia, von Willebrand disease, Congenital Platelet Disorders, Rare Disorders, Bleeding Not Otherwise Specified, Thrombosis/Thrombophilia, or other Non-Neoplastic Hematologic Conditions) and are followed for at least 15 years. Data are collected at enrollment, every six months, annually, and as needed for specific arms or modules. The study records real-world information on what treatments people receive, how treatments are dosed, health care use, patient-reported outcomes, bleeding and clotting events, and long-term safety signals (including allergic reactions, infections, clotting events, inhibitor development, organ issues, and deaths). Product- or therapy-specific modules allow focused data collection on certain drugs or gene therapies. Participants may also opt to contribute blood or other samples to a biorepository for future research.

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.

Study of Ficerafusp Alfa and Pembrolizumab for Head and Neck Cancer

This study focuses on patients with certain types of head and neck cancers that have come back or spread. Researchers are testing a drug called ficerafusp alfa along with pembrolizumab, comparing it to a placebo with pembrolizumab. The aim is to see if the combination is safe and works better than the placebo. The study will happen in two phases. The first phase selects the best dose of ficerafusp alfa. The second phase will see how effective the treatment is when compared to a placebo, with patients randomly assigned to receive either the active treatment or a placebo. Key goals include measuring the response rate of tumors and overall survival among participants, while watching for side effects.

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

Precision Ventilation for ARDS

This is a Phase 3 randomized trial testing whether a personalized way of setting the ventilator can save more lives for patients with moderate to severe ARDS. Patients are randomly assigned to one of two approaches while on a breathing machine. The experimental arm uses an esophageal catheter to measure pressures inside the chest and guides ventilator settings to keep lung stress in a normal range. The control arm receives guided usual care with standard low tidal volume ventilation; esophageal pressure readings are recorded but not shown to the care team. The main measure is death from any cause within 60 days. The study will also look at 28‑day death, time alive and free from the ventilator, need for advanced respiratory support, lung injury markers in blood, breathing complications such as pneumothorax, blood pressure stability, organ function scores, and ICU and hospital length of stay. The goal is to see if precision ventilation reduces lung injury and improves recovery without causing extra harm.

Beat AML Biomarker Treatment Trial

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

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

Using Voice Recordings to Measure Lung Function

This research is studying whether simple voice recordings, like counting out loud or holding a sound, can help measure lung function. It includes adults with neuromuscular diseases and healthy volunteers. These voice tests may help doctors monitor breathing when standard lung tests are difficult or unavailable.

Pompe Disease registry

The Pompe Registry is a global, multicenter, international, longitudinal, observational, and voluntary program for patients with Pompe disease, designed to track the disease's natural history and outcomes in patients, both treated and not.

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

Improving Sleep and Thinking in People with Parkinson Disease Using Different Brain Stimulation Settings

This study is testing whether changing the settings of an implanted brain stimulation device during sleep can improve sleep quality and thinking abilities in people with Parkinson disease. Participants who already have a deep brain stimulation device will receive two different stimulation settings in a random order. One setting uses their usual stimulation day and night, while the other uses a lower setting during sleep. Participants will complete sleep questionnaires, thinking and memory tests, and movement assessments during the study. Researchers hope to learn whether nighttime brain stimulation changes can improve sleep and thinking without worsening movement symptoms.

Sac TMT Maintenance in Ovarian Cancer

This late-stage (Phase 3) study is testing a new maintenance option for people with newly diagnosed advanced ovarian cancer whose tumors are HRD-negative. Participants will have already had surgery and first-line platinum-based chemotherapy and shown no disease growth or some response. The study compares sacituzumab tirumotecan (an antibody-drug therapy) given as maintenance, with or without the targeted drug bevacizumab, to the usual standard care (which may include observation or bevacizumab maintenance). The main goal is to find out if the study treatment keeps cancer from getting worse for longer. Researchers will also track overall survival, later disease progression after new treatments, safety and side effects, and quality of life measures using standard questionnaires. Participants will have regular clinic visits for treatment, scans, and assessments during the treatment and for long-term follow-up. The full study follow-up can last several years to measure how long benefits and side effects last.

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

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

Self Collection HPV Screening Study

This study tests whether people who collect their own vaginal sample for HPV testing get results that are as accurate as samples collected by a clinician during a pelvic exam. Adults 25 and older who were referred for colposcopy because of an abnormal cervical screening test will first collect a vaginal sample themselves, then have a clinician collect a cervical sample and undergo standard colposcopy with biopsy or other procedures if needed. Lab results are compared to see how well self-collection detects high-risk HPV and signs of cervical precancer or cancer. The study also asks participants about ease of use, comfort, and preferences for self-collection. Results will help guide use of self-collection for cervical cancer screening and possible regulatory decisions.

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

Standard Systemic Therapy With or Without Definitive Treatment in Treating Participants With Metastatic Prostate Cancer

This study will compare overall survival in metastatic prostate cancer patients who are randomized to standard systemic therapy plus definitive treatment of the primary tumor versus standard systemic therapy alone.

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

Endometriosis Research for Women With Pelvic Pain

This research is creating a registry and biobank for women with endometriosis and chronic pelvic pain. Researchers will collect health information, survey responses, and biological samples such as blood, saliva, menstrual fluid, and tissue samples obtained during the participant's period or planned medical procedures. The goal is to learn more about what causes endometriosis, how it changes over time, and how to diagnosis endometriosis using menstrual blood. Participation may involve donating samples during a period or a scheduled surgery. While participants may not receive a direct medical benefit, the information gathered may help improve future diagnosis and treatment options for women with endometriosis and pelvic pain.

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.

Testing Comfort of a New Breathing Device

Adults will try a new breathing support device and report comfort and breathing experience. Results may help improve device design.

Acupuncture for Sickle Cell Pain

This research tests whether acupuncture can reduce pain in people with sickle cell disease and how it affects the brain and blood markers. Participants 14–80 years old who have chronic sickle cell pain are randomly assigned to receive ten sessions (30 minutes each) of either traditional needle acupuncture or non-needle laser acupuncture. The main treatment period includes about 14 in-person visits over roughly 6–8 weeks. Investigators will collect pain and health questionnaires, perform sensory testing before and after treatments, and record brain activity using MRI, fNIRS, and EEG. During imaging, controlled pain stimuli will be applied to the lower leg. Blood samples will be taken before and after the treatment course to study biomarkers, and a noninvasive inner-eyelid image will be used to estimate hemoglobin. Participants will be followed monthly for up to 12 months after the in-person visits to track pain and quality of life. Some procedural details are not provided now to preserve study integrity.

Nutrition and Lung Function in CF

This study, called STRONG-CF, is being done by the Jaeb Center for Health Research. It focuses on people with Cystic Fibrosis (CF) and looks at their strength, muscle health, nutrition, and lung function. The main goal is to compare different ways to measure body composition, like how much muscle someone has, using a special scan called DXA, which is considered the best tool for this. The researchers want to see how these measurements relate to things like body mass index (BMI), arm muscle size, hand-grip strength, how far someone can walk in six minutes, and several other health indicators. They will also look at how these measurements change over time and how they relate to lung function, especially in people with different levels of lung health. The study will also check if these body measurements can help predict clinical outcomes, like how well someone with CF is doing. The study will recruit two groups of people with CF based on their lung function: those with an FEV1 (a measure of lung function) below 60% and those with an FEV1 of 60% or above. They will match participants by age, gender, race, and severity of their CF gene. There are some rules about who can join. People can't have had organ transplants, started certain new drugs recently, or had severe lung issues needing antibiotics or steroids recently. Also, people with pacemakers can't join a part of the study. The study is currently recruiting participants, and they hope the results will help in future research on nutrition and health in CF patients.

Panitumumab for KRAS Wild Type Pancreas

This is a phase III randomized trial for adults with pancreatic ductal adenocarcinoma that cannot be removed by surgery or that has spread, whose tumors are KRAS wild type and BRAF V600E wild type by tissue testing. Participants are assigned to one of two groups. One group receives standard second line chemotherapy (one of several standard regimens) alone. The other group receives the same chemotherapy plus panitumumab, an antibody that targets EGFR on tumor cells. Treatment is given in 28 day cycles, typically with drug infusions on days 1 and 15, and continues until the cancer progresses or side effects are unacceptable. The main goal is to see whether adding panitumumab improves overall survival. The study also compares tumor response, progression free survival, side effects, and quality of life. Blood and tumor samples may be collected and stored for future research. Participants are followed for up to three years after randomization.

This study may be appropriate for those with: Metastatic Cancer

FASTEST

This study will evaluate the safety and efficacy of rFVIIa given within 120 minutes of ICH onset compared to placebo. All patient will have standard of care treatment. To determine eligibility, CT scans will be evaluated utilizing the ABC/2 method. This study is an exception from informed consent study although every attempt will be made to consent the LAR.

Early Intensive v/s Escalation Tx

This is an open-label, rater unblinded, randomized clinical trial. Participants will be randomized in a 1:1 ratio to an EHT approach as first-line (alemtuzumab, natalizumab, rituximab, ocrelizumab, or ofatumumab at clinician and participant discretion), or escalation approach (any approved DMT except alemtuzumab, natalizumab, rituximab, ocrelizumab, or ofatumumab as first-line with or without subsequent escalation to any approved DMT).

NAC Treatment for Bipolar Offspring

This is an 8-week, open-label study testing whether daily N-acetylcysteine (NAC) helps reduce depressive symptoms in young people at high risk for bipolar disorder. Participants are 15 to 24 years old and must have a first-degree relative with Bipolar I disorder and current depressive symptoms. Each participant will have a brain scan (resting-state fMRI) at the start and end of the 8 weeks to look for changes in brain connections, especially between parts of the left front of the brain and the left striatum. The study will track mood and anxiety symptoms, overall clinical status, and whether changes in symptoms relate to changes in brain connectivity. This pilot trial aims to see if NAC is safe, well tolerated, and shows signs of benefit, to support a larger future placebo-controlled neuroimaging study.

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

Music and Singing Program for Breast Cancer Survivors

This study is exploring whether creating songs and singing together can help breast cancer survivors feel less stressed and more connected to others. Participants will join small group sessions to help design songs or sing them, complete surveys about stress and mood, and wear a heart monitor during some activities. Researchers hope this program will improve emotional well-being and social support.

Reaching Rural Cancer Survivors Who Smoke Using Text- Based Program

Patients participating in the study will either get a text-based Scheduled Gradual Reduction (SGR) program (Project Reach) where your quit date will be 8 weeks after starting the program, or you will get the National Cancer Institute’s Clearing the Air cessation booklet where you will pick your quit date and this date will be collected. Your quit date must be within 8 weeks of receiving the Clearing the Air cessation booklet. Information on Nicotine Replacement Therapy will be provided to support cessation. You will be followed and your follow-up surveys will be collected regardless of how much you engage with the interventions provided. You will stop receiving intervention texts only if you withdraw from the study and/or text the system STOP as noted in the SGR booklet instructions. After you finish your program, your doctor will continue to follow your smoking status for 6 months.

Testing New Drug Combo for Treating Acute Myeloid Leukemia

This clinical trial is exploring a new treatment plan for patients with newly diagnosed acute myeloid leukemia (AML). The study is testing the effectiveness and safety of combining three anti-cancer drugs: iadademstat, venetoclax, and azacitidine. These drugs work together to stop the cancer cells from growing and spreading. The main aim is to find the best dose and check if this combination approach could help improve health outcomes for these patients. Participants will first undergo an initial treatment phase, where they take these medications daily for certain periods, repeated every month for three months. If no complications arise, they continue the treatment for up to two years. The study also looks at how patients' bodies respond to the treatment over time. Participants need to be newly diagnosed, adults, in good general health, and able to swallow pills. Certain health conditions and previous treatments could disqualify someone from joining the study. During and after treatment, regular check-ups will monitor patients' responses and any side effects. This trial could point the way forward in finding a more effective treatment for AML.

This study may be appropriate for those with: Recurrent Cancer

MM120 Generalized Anxiety Disorder

This Phase 3 study will enroll up to 375 adults (ages 18-74) who have a confirmed diagnosis of generalized anxiety disorder and at least moderate symptoms. Participants will be randomly assigned to receive a single oral dose of MM120 or a matching placebo during a 12-week, double-blind treatment period. The main goal is to compare changes in anxiety symptoms between the MM120 and placebo groups using standard anxiety rating scales. After the 12-week blinded period, participants can join a 40-week open-label extension where they may receive MM120 and will be monitored for safety and symptom control. The study will also track other outcomes such as overall clinical improvement, mood, work and daily functioning, quality of life, and sexual functioning, and will record the need for repeat MM120 treatments during the full 52-week study.

P-BCMA-ALLO1 Allogeneic CAR-T Cells in the Treatment of Subjects With Multiple Myeloma (MM)

Phase 1 study comprised of open-label, dose escalation, multiple cohorts of P-BCMA-ALLO1 allogeneic T stem cell memory (Tscm) CAR-T cells in subjects with relapsed / refractory Multiple Myeloma (RRMM).

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

Itepekimab Nasal Polyps Study

This Phase 3 study will test itepekimab, a laboratory-made antibody that targets IL-33, in adults with chronic rhinosinusitis and nasal polyps that are not well controlled by standard care. Participants will continue intranasal corticosteroid spray and be randomly assigned to one of two itepekimab dose schedules or to placebo. The trial is double-blind and runs up to 52 weeks of treatment with screening before and safety follow-up after. Main goals are to see if itepekimab reduces polyp size and nasal congestion by 24 weeks, and to assess benefits through 52 weeks including sense of smell, CT scan changes, quality of life, lung function in those with asthma, and whether fewer people need steroid courses or sinus surgery. Safety will be monitored throughout, including adverse events and immune responses to the drug. Each participant will have about 9 site visits plus 20 phone or home contacts over the study period.

Study of IMPT-314 in R/​R Aggressive B-cell NHL

This is a Phase 1/2, multi-center, open-label study evaluating the safety and efficacy of IMPT-314, a bispecific chimeric antigen receptor (CAR) targeting cluster of differentiation (CD)19 and CD20 in participants with aggressive B-cell NHL. Two cohorts of participants will be enrolled: 1) CAR T naïve and 2) CAR T experienced. Up to approximately 60 patients (15 per dose level per cohort) will be enrolled in dose finding Phase 1 part of the study, which will determine the recommended phase 2 dose. Phase 2 will enroll up to approximately 40 additional participants (20 per cohort) to evaluate further the safety and efficacy of IMPT-314. IMPT-314 treatment consists of a single infusion of CAR-transduced autologous T cells administered intravenously after a conditioning chemotherapy regimen consisting of fludarabine and cyclophosphamide, administered over 3 days. Individual participants will remain in the active post-treatment period for approximately 2 years. Participants will continue in long-term follow-up for 15 years from treatment.

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

A Study of NX-5948 in Adults With CLL/​SLL Previously Treated

This is a study for patients with relapsed/refractory (R/R) chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) who have previously received treatment with a BTK inhibitor (covalent and non-covalent) and a BCL-2 inhibitor. The main purpose of this study is to test if NX-5948 (bexobrutideg) works to treat patients with CLL/SLL. Participation could last up to 5 years, and possibly longer, as long as the blood cancer is responding to the study treatment.

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

Study of Isatuximab, Carfilzomib, and Dexamethasone for Multiple Myeloma

This clinical study focuses on adults with relapsed or refractory multiple myeloma who have had 1 to 3 previous treatments that did not work. The study tests a combination of drugs: isatuximab, carfilzomib, and dexamethasone. The main goal is to see how well this treatment works in fighting the cancer and how the patients respond to it, both physically and emotionally. Participants go through a screening period, followed by up to a year of treatment. They will visit the study location periodically for evaluations. The study measures various outcomes, including overall response rate and possible side effects like infusion reactions. It's important that participants are able to commit to the protocol and fit specific medical criteria while avoiding recent treatments or conditions that might interfere with the study.

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

Optimizing CNS DHA Delivery

This is a 24-week, randomized, placebo-controlled study testing two forms of DHA (an omega-3 fat) in older adults who have early signs of memory or thinking problems. Participants will be randomly assigned to receive LPC-DHA (a form thought to enter the brain more easily), TAG-DHA (standard triglyceride DHA), or placebo. The main goal is to see which form raises DHA levels in the cerebrospinal fluid (CSF). The study also measures blood and CSF markers linked to brain degeneration and growth (such as amyloid-beta, phospho-tau217, and BDNF), genetic risk (APOE), and tests of memory and executive function at baseline, 12 weeks, and 24 weeks. Some participants will have lumbar punctures to collect CSF. The study will compare how each treatment changes DHA and other markers and whether changes in CSF DHA relate to improvements on memory and thinking tests.

Riliprubart for Refractory CIDP

This is a Phase 3 clinical trial testing riliprubart, given to adults with chronic inflammatory demyelinating polyradiculoneuropathy (CIDP) whose disease did not respond well to usual treatments (IVIg or steroids). Participants are randomly assigned to receive riliprubart or placebo. The first part (double-blind) compares effects through Week 24 and up to Week 48 for some outcomes. After that, an open-label part allows longer treatment and safety follow-up up to a maximum of 111 weeks. The main goal is to measure how many people have meaningful improvement in disability scores (a drop of at least 1 point on the adjusted INCAT scale) by Week 24 and whether improvements last. The study also checks strength, fatigue, quality of life, side effects, and whether the body makes antibodies to riliprubart. People must meet specific diagnosis and stability rules and must not have other causes of neuropathy or recent conflicting treatments. Vaccinations and contraception rules apply.

Revascularization Choices Women Trial

This study enrolls women with multivessel or left-main coronary artery disease for whom the local Heart Team believes either bypass surgery or stent-based artery opening (PCI) is a reasonable option. Participants are randomly assigned to receive either coronary artery bypass grafting (CABG) or percutaneous coronary intervention (PCI) with stents. Researchers will follow participants for 5 to 10 years, checking survival, heart-related events, and many measures of health and quality of life. Questionnaires and phone visits occur at 30 days, 3 months, 6 months, then every 6 months through year 3, and yearly after that up to 10 years. Tests such as an echocardiogram and blood work are done around one year as part of standard care. The main goal is to compare overall survival together with changes in general quality of life over time; many secondary outcomes include disease-specific quality of life, symptoms, hospital stays, heart attacks, strokes, repeat procedures, and complications from treatment.

Vedolizumab Dual Therapy in Crohns

This clinical study tests whether combining two biologic medicines can help adults with moderate to severe Crohn's disease who have not done well on prior advanced treatments. The study has two parts. In Part A, people receive vedolizumab (given into a vein) together with either adalimumab (injected under the skin) or ustekinumab (given into a vein or injected). People who get benefit from this two-drug treatment at Week 26 may move to Part B and receive vedolizumab alone from Week 30 to Week 46. All participants are followed for safety and results for about 76 weeks total (including a safety follow-up after the last dose). The main goals are to measure healing seen on endoscopy and to see how many reach symptom remission, maintain response, stop steroids, and avoid flares. About 100 participants will be enrolled at multiple sites in the United States and Canada.

NX5948 in Relapsed B Cell Cancer

This is a first-in-human Phase 1 study testing NX-5948, a new oral drug that targets and destroys Bruton's Tyrosine Kinase (BTK), in adults whose B‑cell cancers came back or did not respond to prior treatment. The study has a Phase 1a dose-finding part to check safety and pick dose(s), and Phase 1b expansion parts that test the chosen dose(s) in several groups of patients with specific B‑cell cancers (for example CLL/SLL, DLBCL, MCL, FL, MZL, WM, and CNS lymphomas). The main goals are to find a safe dose, learn about side effects and how the body handles the drug, and see if the drug can shrink tumors or control disease. Patients stay on treatment until the cancer gets worse or side effects stop the drug, and they will have follow-up visits for safety and response monitoring.

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

ShortStop HER2 Duration Study

This phase 3 study tests whether people with early HER2-positive breast cancer who have no invasive cancer left after pre-surgery chemotherapy (a pathologic complete response) can safely get a shorter course of HER2-targeted therapy. Participants are randomly assigned to receive trastuzumab (with or without pertuzumab, based on their doctor's choice) for either about 6 months or about 12 months given every three weeks by IV or as a subcutaneous shot. The trial looks mainly at whether cancer recurrence-free survival with 6 months is no worse than with 12 months. It also compares patient-reported quality of life and side effects, and tracks serious side effects, overall survival, and time to brain recurrence. Patients have heart checks and routine imaging during treatment. After treatment, people are followed every 6 months for 5 years, then yearly up to 10 years total.

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

Comparing Mouth and Throat Bacteria in Cancer Surgeries

This study looks at how the bacteria in the mouth and throat change for people having surgery for head and neck cancer. Some patients receive a free flap, which means tissue is moved from another part of the body to help with reconstruction. Others have surgery without a free flap. Participants provide simple swab samples before surgery and again about six weeks after surgery. These samples help researchers learn how surgery affects the natural bacteria in the mouth and throat. The study does not provide direct medical benefit, but what we learn may help improve future cancer care

Study of AJ1-11095 for Untreatable Myelofibrosis Patients

This clinical trial aims to test a new drug called AJ1-11095 on patients with specific types of myelofibrosis-a serious bone marrow disorder-who have not had success with previous treatments. The study focuses on individuals who have used Type I JAK2 inhibitors but didn't benefit from them. In this early-stage research, participants will receive AJ1-11095 orally, and researchers will watch for safety concerns to figure out the best dose to use in future studies. Participants will be closely monitored for any side effects and improvements in symptoms. There will be a gradual increase in dosage until the safest, most effective dose is identified. The trial will also measure changes in symptoms like spleen size and overall health adjustments based on blood tests and other markers. The study will help identify how well the drug works in managing symptoms of myelofibrosis and its impact on patients' quality of life.

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

Study of GIM-531 for Advanced Solid Tumors

This study examines the safety and effectiveness of a new oral drug, GIM-531, specifically aimed at treating advanced solid tumors. It's divided into two phases, with Phase 1 focusing on finding a safe dose and Phase 2 expanding to further assess its safety and initial anti-tumor activity. GIM-531 works by selectively inhibiting certain immune cells called regulatory T-cells, which may help control tumor growth. The study measures the frequency and intensity of side effects, dose limitations, and how well the drug works against tumors. Participants will be those whose cancer has worsened after other treatments and must meet specific health criteria.

This study may be appropriate for those with: Metastatic Cancer

Study of Cemiplimab and Surgery for Advanced Skin Cancer

This clinical trial is exploring whether the addition of an immunotherapy drug, cemiplimab, to the usual treatment of surgery, with or without radiation, is more effective for patients with advanced skin cancer that can be surgically removed. The trial focuses on squamous cell carcinoma that has returned or is at a stage that allows for surgery. Participants will be split into two groups: one receiving surgery alone and the other receiving cemiplimab before surgery, followed by surgery and potentially additional treatment. The researchers aim to see if the combined treatment approach leads to better outcomes such as longer event-free survival, improved disease-free survival, overall survival, and less frequent recurrence when compared to the standard treatment alone. Cemiplimab infusion is delivered through IV over 30 minutes as part of the experimental regimen.

This study may be appropriate for those with: Metastatic Cancer

Studying throat growths in adults to help find better treatments

This study looks at growths in the voice box and airway caused by a virus. When adults have planned procedures to treat these growths, a small amount of tissue (and sometimes blood) is collected and used to grow cells in the lab. Researchers study the virus and genes and test different medicines on the lab grown cells to see what works best. There are no extra study visits. Participation continues while a person receives usual care. The main risk is a privacy breach, and steps are taken to protect information. Results are not shared with participants. About 50 adults are expected to take part.

Studying Swallowing and Voice Function

Adults with and without vocal fold paralysis will take part during a standard swallowing test. Researchers will record how the voice box moves during swallowing and speaking to better understand swallowing safety. There is no direct benefit to participants.

Study of Toripalimab With Chemotherapy for Nasopharyngeal Cancer

This study is looking at how well a combination of drugs, including a new one called toripalimab, works as a treatment for people with advanced nasopharyngeal cancer that has returned or spread. Nasopharyngeal cancer is a type of cancer located in the nose and throat region. The researchers will use special criteria to measure how well the tumors respond to the treatment. People in this study should not have cancer that can be treated with local therapies aimed at curing them or have a quickly progressing illness. They also shouldn't have received this kind of treatment before in a setting where cancer has come back or spread. The study hopes to see positive results, like reducing tumor size and stopping cancer from getting worse, at follow-up periods up to 42 months. Those participating will be regularly checked to see how their body is responding to the treatment.

This study may be appropriate for those with: Metastatic Cancer

A Study of NX-5948 in Adults With Relapsed/​Refractory B-cell Malignancies

A Phase 1, Dose Escalation, and Cohort Expansion Study Evaluating NX-5948, a Bruton's Tyrosine Kinase (BTK) Degrader, in Adults with Relapsed/Refractory B-cell Malignancies

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

Long-Term Study of People Living with Bipolar Disorder

This study is following adults who have bipolar disorder over several years to better understand how their moods, health, and daily life change over time. Participants take part in interviews, surveys, memory and thinking tests, and brain scans, and may wear a Fitbit or use a phone app to track sleep and activity. The goal is to learn why bipolar disorder affects people differently so future care can be more personalized and effective.

Risankizumab Compared to Vedolizumab

This Phase 3b study compares two approved treatments for adults with moderate to severe ulcerative colitis who have not previously received targeted therapies. About 530 participants will be randomly assigned to either risankizumab or vedolizumab. Risankizumab is given by IV during induction and by injection under the skin during maintenance; vedolizumab is given by IV throughout. The main goal is to see which drug leads to more participants having improved appearance of the colon lining (endoscopic improvement) at Week 48. The study lasts roughly 69-71 weeks including screening. Safety, side effects, and disease symptoms will be checked at regular clinic visits and by tests including endoscopy.

Blood sample collection from living kidney donors

Researchers are studying how cells from kidney donors interact with the recipient's immune system during transplant rejection. Living kidney donors may be asked to provide a one-time blood sample, which will be used in laboratory studies only. There is no treatment involved, and participation is voluntary. [PROTOCOL V...6_18_2018 | PDF]

TEMPUS - JUST IN TIME (JIT) Study Listing

This is a listing of TEMPUS "Just In Time" (JIT) studies. Current study-specific protocols and activation details are not included here; investigators, interventions, eligibility, visit schedules, duration, and expected outcomes vary by protocol. For full protocol documents, inclusion/exclusion criteria, visit schedules, potential risks/side effects, and activation requirements, contact the UCCC CTO. A PDF containing the current TEMPUS TIME JIT study listing is available; specific study details can be provided on request.

Study on BAY 2927088 for Lung Cancer with HER2 Mutations

This study is examining a new treatment called BAY 2927088 for people with advanced non-small cell lung cancer (NSCLC) that involves specific changes in the HER2 gene. The goal is to see how well this drug works compared to standard chemotherapy. Participants will receive either the new medication orally or standard chemotherapy via infusions. Doctors will use imaging tests like CT and MRI scans to track cancer progress, along with various health tests. The study aims to observe progression-free survival and overall survival rates, and assess safety through the observation of side effects and adverse reactions.

This study may be appropriate for those with: Metastatic Cancer

Aminoglycoside Treatment in Cystic Fibrosis Study

This study is about finding the best way to treat lung problems in people with cystic fibrosis (CF) when they get worse and need antibiotics through an IV. The study is being done by Seattle Children's Hospital and is led by Chris Goss. It's called the Aminoglycoside Study and is part of a program called STOP360. The study wants to see if using one type of antibiotic (called beta-lactams) is as good as using two types (beta-lactams and another one called aminoglycosides). People with CF who are having a lung problem will be randomly put into one of two groups. One group will get both types of antibiotics, while the other group will only get the beta-lactam antibiotic. This will be done for 14 days. Researchers will look at how well the treatments work by checking the change in lung function after four weeks. They will also look at any side effects that happen during the study. To join the study, people must be at least 6 years old, have a CF diagnosis, and need a 14-day IV antibiotic treatment. They must also have had a positive test for a certain bacteria in the last two years. They cannot join if they are pregnant, have kidney problems, or have had certain other treatments or health issues recently. The study aims to find out which treatment is better for improving lung function and reducing symptoms, while also being safe to use.

Feasibility of an Oral 5 Strain Probiotic (PGC) for GI Toxicity Mitigation During Pelvic Radiation

The exact mechanism of GI symptoms is elusive, but there is sufficient data to suggest that the intestinal microbiome plays a role in radiation-induced GI injury. This feasibility trial will evaluate whether an oral 5 strain probiotic (PGC) can be safely and effectively administered during pelvic RT. PGC will be supplied by Pendulum Therapeutics. Pendulum has completed trials using PGC in non-cancer conditions. The investigators hypothesize that oral supplementation with PGC for GI toxicity mitigation during pelvic radiation is feasible. The intervention will be considered feasible if probiotic tolerability and patient adherence are appropriate. An overall probiotic adherence rate of ≥ 80% by ≥ 70% of patients will be considered acceptable. If feasible, these results will support evaluation of toxicity mitigation in randomized subsequent Phase II/III trials of PGC supplementation during pelvic radiation.

This study may be appropriate for those with: Metastatic Cancer

Tracking Recovery After Vocal Cord Surgery

Adults having surgery for a weak or paralyzed vocal cord will have their recovery tracked over time through routine follow-up visits and questionnaires. The study helps improve future care.

Testing a flushing device to help prevent brain shunt failure

This research study is looking at whether a small flushing device, added during brain shunt surgery, can help prevent the shunt from becoming blocked. Adults with a condition called idiopathic intracranial hypertension, which causes high pressure around the brain, may need a shunt to drain fluid. Blockages are common and often require more surgery. Participants will be taught how to gently press the device under the skin to flush the shunt at home and will be followed during routine clinic visits to see how well it works and if it is safe.

JuxtaFlow Renal Support During Surgery

This study tests the JuxtaFlow Renal Assist Device (RAD) in people with reduced kidney function who need heart surgery with a heart‑lung machine. JuxtaFlow gently applies a small negative pressure to the kidney collecting system through the renal pelvis. The goal is to boost filtration and lower pressure inside the kidney while patients go through the stress of surgery and cardiopulmonary bypass. The trial randomly assigns patients to receive JuxtaFlow plus usual care or to receive usual care alone. The main measures are the peak change in blood creatinine within 96 hours after surgery and the number and type of side effects up to 30 days. The study also looks at time spent in ICU and hospital, how often dialysis is needed, urine output and electrolytes, and kidney function at 14 and 30 days. Participants will receive the device around surgery and be followed while in hospital and at planned visits up to 30 days; some outcome data such as length of stay are tracked through study completion (about 1 year for the U.S. cohort).

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.

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.

Continuous Passive Motion After Fixation

This study will test whether using a continuous passive motion (CPM) machine after surgery helps control pain and reduce narcotic use in people who had surgery to fix certain pelvis or knee fractures. Adults with an isolated acetabular fracture, supracondylar femur fracture, or tibial plateau fracture who have had surgery will be asked to join. Participants are randomized to either a CPM plus usual physical therapy or usual care with physical therapy alone. The CPM is started after surgery and used while the patient is awake in bed for two hours on and two hours off when not working with physical therapy. Nurses and therapists will record daily pain scores and track pain medications during the hospital stay. Incisions will be checked daily and any problems will be monitored. At one year, participants will complete standard functional surveys to compare recovery. Data are recorded in the electronic health record.

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.

Nipocalimab versus IVIG for FNAIT

This is a Phase 3 study testing whether nipocalimab (an investigational antibody) can prevent severe problems in babies caused by fetal and neonatal alloimmune thrombocytopenia (FNAIT). Pregnant people who are 13 to 18 weeks pregnant, have a prior pregnancy affected by FNAIT, and have maternal antibodies plus a fetus with the matching platelet antigen may join. Participants are randomly assigned to receive either nipocalimab or standard IVIG during pregnancy. The main goal is to see whether nipocalimab lowers the chance that the fetus or newborn will die, have severe bleeding, or be born with a very low platelet count (under 30 x 10^9/L) in the first week after birth. The study will also track newborn platelet counts at birth, need for platelet transfusions or IVIG after birth, bleeding or infections in the baby, and the baby's development up to about 2 years. Maternal safety and any antibodies to nipocalimab are monitored. The study excludes people with multiple pregnancies, serious prior pregnancy complications like severe preeclampsia, major heart or stroke history, known allergies to the study drugs, or certain immune disorders.

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

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.

Frexalimab Versus Teriflunomide in MS

This is a pair of Phase 3, randomized, double-blind studies comparing an investigational antibody called frexalimab to the approved oral drug teriflunomide in adults with relapsing multiple sclerosis (ages 18-55). Each study measures how often participants have relapses over the study period (annualized relapse rate) and follows safety, disability changes, MRI lesion counts, brain volume, cognitive tests, and blood markers. The studies are event-driven: every participant will be treated at least 12 months, and many will be followed up to about 156 weeks (three years). Visits are every 4 weeks for the first 6 months, then every 3 months, with an end-of-study visit and three follow-up visits. Safety monitoring includes tracking adverse events, lab tests, ECGs, and antibodies to the drug. The goal is to see if frexalimab reduces relapses and is safe compared with teriflunomide.

Studying the Brains of Elite Athletes

This research study looks at how the brains of elite athletes may be different from others. Participants complete advanced brain scans that measure brain structure and brain activity while resting and performing simple tasks. The goal is to understand how years of intense training may shape the brain and support high-level athletic performance. The study involves one short visit, or two shorter visits, and does not involve treatment or changes to medical care.

Testing Radiation Plus Immunotherapy for Metastatic Renal Cell Cancer

This clinical trial is testing whether adding a special type of radiation therapy called stereotactic ablative radiation therapy (SABR) to the usual treatment of immunotherapy can help patients with renal cell cancer that is metastatic, meaning it has spread to other parts, or cannot be surgically removed. Patients are divided into two groups. One group receives only immunotherapy, while the other group gets both SABR and immunotherapy. The hope is that using both SABR and immunotherapy could shrink tumors or stop them from growing. By doing this, doctors aim to see if fewer surgeries are needed and if the time without cancer worsening can be extended. The study will also look at safety and possible side effects such as immune system reactions.

This study may be appropriate for those with: Metastatic Cancer

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

Rina S Versus Standard Chemotherapy

This is a global Phase 3 study that will enroll about 544 people with recurrent or progressive endometrial cancer after prior therapy. Participants are randomly assigned 50:50 to get either the investigational drug Rinatabart Sesutecan (Rina S) or the investigator's choice of standard chemotherapy (paclitaxel or doxorubicin). Everyone receives active treatment; no one gets a placebo. The study will follow participants for up to about 3 years. The main goals are to compare how long patients live without their cancer getting worse (progression free survival) and overall survival. The study will also look at tumor response, duration of response, side effects, and quality of life. Treatment time varies by person but is expected on average to be about 4 to 6 months. Visits to the study site are required for treatment and assessments.

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

Vaccine Trial for Adults with Severe RRP

This study is testing a vaccine for adults with repeated airway growths that often need surgery. Participants receive four vaccine injections and are followed to see if surgery is needed less often and if symptoms improve.

Studying Fat Injections for Voice Problems

Adults already undergoing voice-related surgery may allow unused fat tissue to be studied. No extra procedures are added, and care is unchanged.

Testing LY3962673 in KRAS G12D-Mutant Solid Tumors

This study is examining a new drug, LY3962673, which aims to treat certain types of advanced cancer that have a specific mutation known as KRAS G12D. These cancers include pancreatic, lung, and colorectal cancers. The study is testing how safe LY3962673 is when used alone and in combination with other chemotherapy drugs, as well as how well it works in reducing tumor size. It will last about five years, and participants will undergo various assessments to track their response to the treatment. The study hopes to determine both the best way to use the drug and its effectiveness over time. Participants who previously had treatments that didn't fully work for these specific cancers might qualify.

This study may be appropriate for those with: Metastatic Cancer

Weekly Subcutaneous injection of Telitacicept vs. placebo

This Phase 3 study tests telitacicept, a medicine given to lower immune activity from certain B cells, in people with generalized myasthenia gravis (gMG). gMG causes muscle weakness that usually gets worse with use. Adults with confirmed gMG and positive antibodies will be randomly given telitacicept or a placebo without knowing which they get for the first 24 weeks. The main goal is to see if daily-life symptoms improve after 24 weeks. Other goals include measuring muscle strength and quality of life. Safety will be monitored. After the 24-week blinded part, people can join an open-label extension to receive telitacicept and continue follow-up. The study aims to find out if telitacicept helps reduce weakness and is safe for people with gMG.

Safety Study of YL211 for Advanced Solid Tumors

This clinical trial tests a new drug called YL211 to see if it's safe and effective for people with advanced solid tumors that have no other treatment options. The study is in its early stages (Phase 1) and takes place at multiple centers. There are three parts: Part 1 tests different doses to find the most tolerable dose; Part 2 checks the safety and impact in more patients; and Part 3 looks at safety and effectiveness at the chosen dose. People participating will receive the medicine intravenously and continue until conditions for stopping arise. Participants should be adults with advanced solid tumors, generally healthy apart from cancer, and must not have uncontrolled illnesses or recent allergies related to similar medicines. The study will observe any side effects, how the drug moves through the body, and how well it works against the cancer over approximately three years.

This study may be appropriate for those with: Metastatic Cancer

Comparing Surgical Options for Treating Recurrent Carpal Tunnel Symptoms After a Prior Release

This study compares three different surgical approaches used when carpal tunnel symptoms return after a previous surgery. Some people experience relief at first, but symptoms later come back, and doctors must decide which type of revision surgery will give the best results. Because there is not enough research comparing these options, this study is designed to help provide clearer answers. Adults who have recurrent carpal tunnel symptoms and have tried nonsurgical treatments such as splinting or injections may qualify to participate. After completing a baseline evaluation, including hand strength testing and questionnaires, participants are randomly assigned to one of three revision procedures. All three techniques are currently used in clinical practice. After surgery, participants will return for follow‑up visits at several points over two years. At each visit they will complete surveys and have simple hand function checks to track improvement in symptoms, comfort, and daily use of the hand. By comparing recovery, hand function, and symptom improvement across different revision procedures, the study aims to help surgeons choose the best option for future patients. The study also looks at whether pre‑surgery symptoms, nerve test results, or imaging findings can help predict how well someone will recover after revision surgery.

Safety and Efficacy of Adjunct Therapies In Adults with Type 1 Diabetes: Multicenter, Registry Study

This is a multicenter registry study for adults with type 1 diabetes (T1D) who have been prescribed a GLP-1 receptor agonist (GLP-1RA), an SGLT inhibitor (SGLTi), or both medications as part of their usual medical care. The study will follow participants for 1 year. Approximately 300 participants will be enrolled across 20 clinical centers in the United States. Information collected during the study may include laboratory results, continuous glucose monitor (CGM) data, insulin use, weight and body measurements, blood pressure, patient questionnaires, and information about any side effects or complications experienced during the study period. The information gathered may help researchers better understand the use of GLP-1RA and SGLTi therapies in adults with type 1 diabetes.

STRATEGY FOR IMPROVING STROKE TRMT RESP

SISTER is a Phase-2, prospective, randomized, placebo-controlled, blinded, dose finding trial that aims to determine the safety and preliminary efficacy of TS23, a monoclonal antibody against the alpha-2 antiplasmin (a2-AP), in acute ischemic stroke.

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.

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

Afimkibart for Crohns Disease Study

This is a Phase 3 clinical trial testing Afimkibart (RO7790121), an investigational medicine, in adults with moderate to severe Crohn's disease. The study is randomized, double-blind and placebo-controlled. Participants who qualify will receive Afimkibart or placebo as induction and maintenance treatment and will be followed through key timepoints up to about one year. The study looks at whether the drug can bring patients into clinical remission (fewer symptoms and lower disease activity scores) and improve what doctors see on endoscopy (healing of the bowel lining). Important measures include the Crohn's Disease Activity Index (CDAI) and the Simple Endoscopic Score for Crohn's Disease (SES-CD). Other outcomes include stool frequency, abdominal pain, quality of life, fatigue, bowel urgency, and safety events. People must have failed or not tolerated at least one approved Crohn's therapy to join. Some health issues such as active infections, certain fistulas, recent cancers, pregnancy, and major prior bowel surgery can keep someone out of the study. The study will monitor side effects, serious adverse events, and the need for steroids during treatment.

Study of PF-07934040 for Advanced Tumors with KRAS Gene Mutations

This clinical study is testing a new cancer medicine called PF-07934040. The study focuses on people with advanced solid tumors, which are cancers that don't go away or stay away after treatment. These tumors have a specific genetic mutation in the KRAS gene, which can make cancer cells grow quickly. The study includes people with types of cancer such as non-small cell lung cancer (NSCLC), colorectal cancer (CRC), and pancreatic ductal adenocarcinoma (PDAC). The study is in Phase 1, meaning it's looking at how safe the medicine is and what effects it has. Researchers also want to find the best dose to give to patients. The medicine can be taken alone or with other cancer treatments. Participants will take PF-07934040 as a pill twice a day in cycles of either 21 or 28 days. Those who are also getting other treatments will have those given by IV at the clinic. The study will last up to four years, with participants visiting the clinic 1 to 4 times every cycle. They can continue the treatment as long as it helps control their cancer. After stopping the medicine (usually around two years), they will be followed for two more years to check on their health. To join the study, participants must have a KRAS gene mutation and show that their cancer has not responded to standard treatments. They must also have a good level of daily functioning and at least one measurable tumor that has not been treated with radiation. There are also specific criteria for different cancer types, such as the number of previous treatments. People cannot join if they have certain health problems, like lung diseases that need steroids, immune system issues, or severe nerve damage. They also can't participate if they've had major surgery or radiation therapy recently, or if they have allergies to the study treatments. The study aims to learn if PF-07934040 is safe and effective in treating these advanced cancers. It will measure safety through any side effects and lab test changes. It will also look at how many participants respond to the treatment, how long it takes for the medicine to reach its peak in the body, and how long it stays there.

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

Subcutaneous weekly injection by autoinjector for Generalized Myasthenia gravis

Study IMVT-1402-3101 is a Phase 3, multicenter, randomized, placebo-controlled, double-blind study to assess the efficacy, safety and tolerability, PK, and PD of IMVT-1402 in participants 18 to 80 years old inclusive who have mild to severe gMG. Eligible participants will be randomized in a 1:1:1 ratio to receive blinded IMVT-1402 600 mg subcutaneous (SC) once weekly (QW), IMVT-1402 300 mg SC QW, or placebo SC QW for 12 weeks during Period 1