Office of Research
Clinical Trials

NTX001 Nerve Repair Phase 3

This is a Phase 3 randomized, blinded study testing NTX-001, a single-use surgical product used with standard suture neurorrhaphy, in adults with severed nerves in the upper limb that need surgical repair. NTX-001 uses a PEG-fusion approach intended to reconnect many axons at the time of repair to reduce the usual nerve degeneration that follows a cut nerve. The trial compares NTX-001 plus standard suture repair to standard suture repair alone. Adults 18 to 80 years old with class 4 or 5 nerve transections repaired within 48 hours may enroll unless they need grafts, have certain medical problems, allergies to PEG or silicone, are pregnant, or are in other recent trials. The study measures hand function and pain (Michigan Hand Questionnaire and Numeric Pain Rating Scale), nerve tests (EMG and nerve conduction), sensory and motor scores, time to regain function, and safety measures including wound and device related events. Follow up includes an operating room assessment and scheduled visits up to 48 weeks to track recovery and safety.

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

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.

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.

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.

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.

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).

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.

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.

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.

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.

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.

Efficacy and Safety of Iptacopan for IC-MPGN

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

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

Trial for Lumateperone in Teens with Schizophrenia or Bipolar Disorder

This research aims to understand the safety and tolerance of the drug lumateperone in teens aged 10 to 17 who have been diagnosed with either schizophrenia or bipolar disorder. The trial lasts up to 30 weeks, starting with a 2-week screening period, followed by a 26-week period where participants take lumateperone daily. After that, there's a 2-week follow-up to check on safety. The main goal is to see how safe the drug is by monitoring any adverse effects that might happen in these patients. Both new participants and patients from previous related studies can join according to their diagnosis and history. Those with other psychiatric disorders, severe risk of self-harm, or dangerous behavior are not eligible.

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.

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.

SPHERES Registry for NMOSD

This is a long-term, forward-looking registry for adults with NMOSD who are under a neurologist's care at UC Health. People who join will have their medical information, treatment use, relapses, and patient-reported outcomes collected on a regular basis. The goal is to learn how NMOSD starts and changes over time, to see how treatments work and how safe they are in everyday care, and to better understand the effects on daily life and costs. The registry may link a person's data to other public or private databases (with consent) to allow more research on health care use, costs, and treatment adherence. Participants may be asked to complete extra short surveys from time to time, for example about caregiver burden or work impact. No study drug is given; this is an observational study focused on collecting real-world data.

Pasritamig for Advanced Prostate Cancer

This is a late‑stage phase 3 study testing pasritamig (JNJ‑78278343), a medicine that redirects a person's T cells to target a prostate cancer protein, in people with metastatic castration‑resistant prostate cancer (mCRPC) whose disease has progressed after standard treatments. Participants are randomly assigned to receive pasritamig plus best supportive care or placebo plus best supportive care. The main goal is to compare overall survival between the two groups. Other goals include measuring time to disease progression by imaging, time to symptom or pain worsening, time to events in the bones, lab changes, and side effects. Participants must be on ongoing hormone suppression and have already received available life‑prolonging therapies appropriate for them. The study follows participants for up to about 2 years and 8 months to assess outcomes.

This study may be appropriate for those with: Metastatic Cancer