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Here are the studies that match your search criteria. If you are interested in participating, please reach out to the contact listed for the study. If no contact is listed, contact us and we'll help you find the right person.

428 Study Matches

A randomized, double-blind, placebo-controlled, multicenter study to evaluate the safety, efficacy, and pharmacokinetics of budesonide extended-release tablets administered once daily in pediatic subjects aged 5 to 17 years with active, mild to moderative ulcerative colitis

The purpose of this research study is to test the safety and effectiveness of Budesonide in low and high dose extended- release tablets in pediatric participants with active, mild to moderate Ulcerative Colitis and to evaluate the level of budesonide that remains in the blood after taking it. Participants will be asked to take an oral (by mouth) form of Budesonide or a placebo once daily for 8 weeks. A placebo is a tablet that does not contain any active study drug (Budesonide).

Principal Investigator: Vikram Christian
Age Group: Up to 18 years old
This study is NOT accepting healthy volunteers
IRB Number: STUDY00022572
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Inclusion Criteria:

• 5 to 17 years old
• diagnosis of Ulcerative Colitis (UC)
• weight is greater than 13.6 kg (30 pounds)
• active UC of mild or moderate severity
• see link to clinicaltrials.gov for complete inclusion criteria
Exclusion Criteria:

• current or prior diagnosis of Crohn's disease or indeterminate colitis
• prior gastrointestinal surgery, except appendectomy or hernia
• see link to clinicaltrials.gov for complete exclusion criteria
Conditions: Digestive & Liver Health
Keywords: UC, Ulcerative Colitis
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SUSTAINED RELEASE ORAL FORMULATION FOR TREATMENT OF PARKINSON'S DISEASE

Medications used to treat Parkinson's disease will be delivered using a sachet ; placed in the oral/buccal cavity (between cheek and gum of lower jaw). This study may be a good fit for you if you are healthy, between the ages of 18 and 65, and aren’t currently taking regular medications. We expect that you will be in this research study for one visit, approximately 7 hours total. Compensation and transportation expenses will be provided.

Principal Investigator: Khalaf Bushara
Age Group: 18 years and over
This study is also accepting healthy volunteers
IRB Number: STUDY00024501
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Inclusion Criteria:

• Normal healthy
• 18-65 years of age
• Not currently taking medications regularly
• Able to fast 6 hours, only water allowed
Conditions: Brain & Nervous System
Keywords: Healthy adults
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D2D - What's Bugging You? Assessing the public's knowledge, attitudes, and perceptions of tick and mosquito borne diseases.

You are invited to take part in a survey to help us learn more about what people know and think about diseases that are spread by ticks and mosquitoes. This study is being conducted by the researchers at the University of Minnesota Medical School on the Duluth Campus. The goal is to understand how people feel about these diseases and how much they know about how to protect themselves.

Principal Investigator: Clara Smoniewski
Age Group: Not specified
This study is also accepting healthy volunteers
IRB Number: STUDY00025228
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Inclusion Criteria:

• MN and WI residents
• age 16 and up
• English speaking
Conditions: Infectious Diseases, Prevention & Wellness, Community Health
Keywords: climate change, Lyme disease, vector-borne disease
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Assessment of customized bimodal stimulation for tinnitus

We are testing the usability of a medical device designed to treat tinnitus. The Lenire device is made by Neuromod Devices and is CE approved for use in Europe and FDA approved in the US. This neuromodulation device delivers sounds and tongue stimulation that work together to reduce tinnitus. We are interested in your feedback after using the Lenire device with the modified stimulation program. This research study lasts about 3 months.

Principal Investigator: Lei Feng
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: STUDY00024155
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Inclusion Criteria:

• Subjective Tinnitus
• Tinnitus has a dominant pitch
• willing to commit to a12 week study
Exclusion Criteria:

• objective tinnitus
• started using hearing aids within the past 3 months
• have an electro-active implanted device
Conditions: Ear, Nose & Throat
Keywords: hearing, neuromodulation, Tinnitus, bimodal stimulation
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A placebo-controlled, randomized clinical trial to assess the safety, feasibility, and pharmacokinetics of Microbiota transplant therapy with antibiotic preconditioning and fiber supplementation in patients with pulmonary arterial hypertension

There is evidence that the gut microbes interact with the body’s immune system, and people with pulmonary hypertension may have altered composition of gut microbes. We are studying whether transplanting gut microbes from healthy donors using a treatment called microbiota transplant therapy may have beneficial effects on pulmonary arterial hypertension.

Principal Investigator: Thenappan Thenappan
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: STUDY00022382
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Inclusion Criteria:

• ages 18-75
• diagnosis of pulmonary arterial hypertension (PAH)
• on stable treatment for PAH for one month prior to enrollment
• able to swallow capsules
• able to provide blood sample and fecal sample
Exclusion Criteria:

• active inflammatory bowel disease or celiac disease
• women who are pregnant or breastfeeding
• presence of ileostomy or colostomy
• on immunosuppressants (calcineurin inhibitors, prednisone at a dose of 20 mg/day or more, methotrexate, azathioprine, immunosuppressive biologics, JAK inhibitors).
• history of solid organ or bone marrow transplant
• anticipated recurrent antibiotic use (patients with frequent urinary tract infections or sinusitis)
• history of severe anaphylactic food allergy
• receiving cancer chemotherapy, immunotherapy, or radiation
Conditions: Heart & Vascular, Microbiota
Keywords: Microbiota transplant therapy, PAH, pulmonary arterial hypertension, Clinics and Surgery Center (CSC), gut
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Proteomics of Post-Operative Complications in Patients undergoing CABG

This study aims to identify independent blood-based risk factors for postoperative complications and near-term events among patients undergoing CABG surgery. In particular, this study will be using proteomics, the study of all proteins produced by the cells found in blood, as well as genetic analysis to identify potential predictive markers of postoperative complications. We will collect blood samples from before and after surgery. This study does not involve any medical treatment other than the one prescribed by your doctor, nor does it involve any additional medical procedures.

Principal Investigator: Brian Steffen
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: STUDY00018957
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Inclusion Criteria:

• Undergoing CABG procedure at MHealth Fairview hospital
• 45-80 years of age
Exclusion Criteria:

• high risk patient as determined by the Society of Thoracic Surgeons (STS) Risk Assessment Score after designated number of patients have been included (study staff will review)
Conditions: Heart & Vascular
Keywords: Coronary Artery Bypass Graft (CABG), Heart Surgery
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A Multicenter Observational Study to Characterize Growth in Children with Idiopathic Short Stature

This research is being done to learn more about how children with idiopathic short stature grow. About 600 children with idiopathic short stature will be in this study across the world. The study will last a minimum of 6 months (i.e., three study visits). After a child has been in this study for at least 6 months, participants may be offered the option to exit this study and enroll in a different study with growth promoting agents.

Principal Investigator: Nishitha Pillai
Age Group: Up to 18 years old
This study is NOT accepting healthy volunteers
IRB Number: STUDY00021903
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Inclusion Criteria:

• participants must be at least 2 years old
• no more than 14 years old if female, or less than16 years old if male
• height Z-score is at least -2.5 SDs compared to age and sex matched norms
• able to walk ambulatory stand without assistance (not applicable for children who are less than 5 years of age and less than 104 cm i.e. 41 inches in length)
Exclusion Criteria:

• systemic disease or condition that may cause short stature, eg renal, neoplastic, pulmonary, cardiac, gastrointestinal, immunologic or metabolic disease
• presence of one or more pituitary hormone deficiencies (ACTH [adrenocorticotropic hormone], ADH [antidiuretic hormone], FSH [follicle-stimulating hormone], GH [growth hormone], LH [luteinising hormone], TSH [thyroid-stimulating hormone]).
• diagnosis of hypothyroidism, adrenal insufficiency or hypogonadism (treated or untreated).
• Growth Hormone (GH) level below 10 ng/mL following a stimulation test. This does not apply to potential participants who are currently being treated with hGH for ISS
• known chromosomal imbalance or genetic variant causing short stature syndrome, including but not limited to Laron syndrome, Prader-Willi syndrome, Russell-Silver syndrome, Turners syndrome, disproportionate skeletal dysplasias, abnormal short stature homeobox (SHOX) gene analysis, Rasopathy (including Noonan’s Syndrome), or absence of GH receptors
• bone age advanced over chronological age by more than 3 years
• active cancer, chemotherapy or radiation therapy
Conditions: Children's Health, Diabetes & Endocrine, Rare Diseases, Rare Diseases
Keywords: Growth, Growth Hormone, Idiopathic Short Stature, ISS
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A Phase III, Randomized, Controlled, Global Multicenter Study to Evaluate the Efficacy and Safety of Oral Tinengotinib versus Physician s Choice in Subjects with Fibroblast Growth Factor Receptor (FGFR)-altered, Chemotherapy- and FGFR Inhibitor-Refractory/Relapsed Cholangiocarcinoma (FIRST-308) (FIRST-308)

The main purpose of this study is to learn how well tinengotinib works and how safe tinengotinib is compared with the study doctor’s choice of chemotherapy treatment. The purpose of Part A of the study will be to determine the best dose of tinengotinib to use in Part B of the study. The purpose of Part B is to learn more about how well tinengotinib works and how safe it is compared with the study doctor’s choice of treatment.

Principal Investigator: Edward Greeno, M.D.
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: STUDY00021600
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Inclusion Criteria:

• adenocarcinoma of biliary origin (bile ducts) that can't be surgically removed or is metastatic (spread to other areas of the body)
• cancer has FGFR2 fusion/rearrangement gene status
• received at least one line of prior chemotherapy and one FDA approved FGFR inhibitor
• see link to clinicaltrials.gov for complete inclusion and exclusion criteria
Exclusion Criteria:

• received two or more FGFR inhibitors, either approved or investigational drugs
• brain or central nervous system (CNS) metastases
• presence of another cancer that requires treatment
• uncontrolled hypertension (blood pressure of ≥ 150 mm Hg systolic and/or ≥ 90 mm Hg diastolic despite treatment with antihypertensive medications)
Conditions: Cancer
Keywords: Cholangiocarcinoma, Clinics and Surgery Center (CSC)
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Circuit-Based Deep Brain Stimulation for Parkinson's disease; Udall Clinical Core

The goal of this study is to provide comprehensive longitudinal assessments of a cohort of PD patients before, during, and after DBS surgery, including neurological, neurophysiological, and neuropsychological data.

Principal Investigator: Scott Cooper
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: 1611M00822
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Inclusion Criteria:

• age 21 years and older
• diagnosis of Parkinson's disease
• approved candidate for standard of care DBS surgery at the University of Minnesota
Exclusion Criteria:

• diagnosis of dementia
• women who are pregnant
Conditions: Brain & Nervous System
Keywords: Clinics and Surgery Center (CSC), DBS, Deep Brain Stimulation, Parkinson's Disease
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A Phase 1a/b Study of ADRX-0405 in Subjects with Select Advanced Solid Tumors

This study aims to evaluate the safety and tolerability of ADRX-0405 in people with advanced cancer and determine the optimal dose for treatment.

Principal Investigator: Emmanuel Antonarakis
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: STUDY00024172
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Inclusion Criteria:

• age 18 or older
• Phase 1a: confirmed advanced solid tumors (metastatic castration resistant prostate cancer (mCRPC), gastric cancer (GC), and non-small cell lung cancer (NSCLC))
• Phase 1b: confirmed prostate adenocarcinoma that is confirmed to be castration resistant and that is intolerant/resistant to standard of care (SOC) therapies
• see link to clinicaltrials.gov for complete inclusion criteria
Exclusion Criteria:

• active and uncontrolled central nervous system metastases
• have received an anticancer or investigational therapy prior to the first dose of study drug
• history of ILD/pneumonitis requiring steroid treatment within the past 2 years, current ILD/pneumonitis, or an active infection requiring systemic antibiotics (prophylactic antibiotics permitted)
• see link to clinicaltrials.gov for complete exclusion criteria
Conditions: Cancer
Keywords: Clinics and Surgery Center (CSC), Cancer
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A Multicenter, Randomized, Parallel-group, Double-blind, Two-arm, Phase III Study to Evaluate the Safety and Efficacy of Anifrolumab Compared with Placebo in Male and Female Participants 18 to 70 Years of Age Inclusive with Systemic Sclerosis (DAISY)

We are doing this study to learn more about anifrolumab (SAPHNELOTM) in patients with systemic sclerosis and to better understand the studied disease and associated health problems. Systemic sclerosis (scleroderma) affects the skin as well as other organs, such as blood vessels, muscles and joints, digestive tract, kidneys, lungs and heart.

Principal Investigator: Jerry Molitor
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: STUDY00019243
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Inclusion Criteria:

• 18 to 70 years old
• diagnosis of systemic sclerosis within 6 years from first non-Raynaud's symptoms
• skin at injections sites is without symptoms
• see link to clinicaltrials.gov for complete inclusion and exclusion criteria
Exclusion Criteria:

• severe heart or lung disease
• history of any other inflammatory diseases
• history of hematopoietic stem cell transplantation or solid organ or limb transplantation
• current or a history of cancer within past 5 years
• active current or history of reoccurring infections
Conditions: Arthritis & Rheumatic Diseases
Keywords: Clinics and Surgery Center (CSC), systemic sclerosis, Scleroderma
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Effects of tobacco and nicotine cessation on biomarkers

This study will bank biological samples (cells from mouth, urine, blood, saliva) to investigate the effects of quitting smoking or vaping on different markers in the body.

Principal Investigator: Stephen Hecht, PhD
Age Group: Up to 18 years old
This study is NOT accepting healthy volunteers
IRB Number: STUDY00020438
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Inclusion Criteria:

• 21 years of age or older
• in good health
• smokes cigarettes daily
• willing to abstain from smoking for 15 days
Exclusion Criteria:

• marijuana use
Conditions: Prevention & Wellness
Keywords: cigarettes, lozenges, nicotine, patches, smoking, smoking cessation, tobacco
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A Multicenter Observational Study of GammaTile Surgically Targeted Radiation Therapy (STaRT) in Intracranial Brain Neoplasms

We are studying the effectiveness of GammaTiles TM that are placed during surgery done to remove brain tumors. GammaTiles TM are used to deliver radiation to the surgical area in the brain. We are collecting information about the effectiveness and side effects and will compare to people who receive the usual treatment.

Principal Investigator: Lindsey Sloan
Age Group: Not specified
This study is NOT accepting healthy volunteers
IRB Number: SITE00000958
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Inclusion Criteria:

• undergo maximum safe resection of intracranial neoplasm(s) AND implantation of GammaTiles.
Exclusion Criteria:

• unable to have pre-operative and post-operative imaging for disease and implant assessment
• major medical or psychiatric illness (study staff will review)
• unable to speak and read English
Conditions: Brain & Nervous System, Cancer
Keywords: Brain Tumor
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A Phase 1B/2 pan-tumor, open-label study to evaluate the efficacy and safety of ifinatamab deruxtecan (I-DXD) in subjects with recurrent or metastatic solid tumors (IDeate-Pantumor02)

The purpose of this study is to learn more about an investigational drug called ifinatamab deruxtecan (I-DXd; DS-7300. It is being studied to see if it is safe, and if cancer improves while taking it. I-DXd is a type of drug called an antibody drug conjugate (ADC). ADCs are made to attach to tumor cells to deliver chemotherapy directly to tumor cells while sparing healthy cells.

Principal Investigator: Deanna Teoh
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: STUDY00022970
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Inclusion Criteria:

• disease progression on or after the previous standard-of-care regimen for advanced/metastatic cancer
• unable to do strenuous activity but able to walk and do work of a sedentary nature, e.g., light house work, office work
• additional criteria required based on the type of cancer (pancreatic, breast, bladder, etc.)
• see link to clinicaltrials.gov for complete inclusion and exclusion criteria
Exclusion Criteria:

• prior treatment with orlotamab, enoblituzumab, or other B7-homologue 3 (B7-H3)-targeted agents, including I-DXd
• clinically active brain metastases, spinal cord compression, or leptomeningeal carcinomatosis, defined as untreated or symptomatic, or requiring therapy with steroids or anticonvulsants to control associated symptoms.
Conditions: Cancer
Keywords: Cancer, Recurrent or Metastatic Solid Tumors, Clinics and Surgery Center (CSC)
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Strength and Muscle Related Outcomes for Nutrition and Lung Function in CF (STRONG-CF)

There are currently two main ways of measuring nutrition in the Cystic Fibrosis (CF) population: body mass index (BMI) and laboratory values. This study plans to look at more ways to measure nutrition, and body composition, like the percentages of fat, bone and muscle in your body. One of the ways we will measure these items is by using dual energy X-ray absorptiometry (DXA) scan, which is a type of x-ray. This study hopes to provide researchers with more detailed information about nutrition and body composition in adults with CF.

Principal Investigator: Joanne Billings
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: SITE00001806
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Inclusion Criteria:

• diagnosed with Cystic Fibrosis
• clinically stable with no significant changes in health status within the 14 days prior to the first study visit
Exclusion Criteria:

• no prior solid organ transplantation
• no initiation of an investigation drug within 28 days before
• no initiation of new chronic therapy (e.g., ibuprofen, azithromycin, inhaled tobramycin, Cayston, CFTR modulator) within 28 days
• no acute use of antibiotics (oral, inhaled or IV) or acute use of systemic corticosteroids for respiratory tract symptoms within 14 days
Conditions: Respiratory System, Rare Diseases, Rare Diseases
Keywords: cystic fibrosis, Clinics and Surgery Center (CSC)
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MT2021-11: An Open-label, Single-arm, Multicohort, Phase 2 Study to Assess the Efficacy and Safety of Tabelecleucel in Subjects with Epstein-Barr Virus-associated Diseases

This research is being done to determine whether the investigational drug tabelecleucel (allogeneic Epstein-Barr virus-specific cytotoxic T lymphocytes [EBV-CTLs]) can help people with EBV-associated diseases.

Principal Investigator: Supriya Gupta
Age Group: Not specified
This study is NOT accepting healthy volunteers
IRB Number: STUDY00013494
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Inclusion Criteria:

• diagnosis of Epstein-Barr Virus (EBV) disorder
• able to walk and do all selfcare but unable to carry out any work activities; up and about more than 50% of waking hours
• see link to clinicaltrials.com for additional inclusion criteria
Exclusion Criteria:

• women who are breastfeeding or pregnant
• currently active Burkitt, T-cell, natural killer/T-cell lymphoma/LPD, Hodgkin, plasmablastic, transformed lymphoma, active hemophagocytic lymphohistiocytosis, or other malignancies requiring systemic therapy
• serious known active infections
• additional exclusion criteria apply (study staff will review)
Conditions: Cancer, Infectious Diseases
Keywords: Clinics and Surgery Center (CSC), Epstein-Barr Virus (EBV)
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MT2023-51 A Phase 2 Multicenter Study of Autologous Tumor Infiltrating Lymphocytes (LN-145) in Patients with Metastatic Non-Small-Cell Lung Cancer

This study is being done to learn more about the efficacy and safety of LN-145 in participants with metastatic stage IV non-small cell lung cancer.

Principal Investigator: Benjamin Manning
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: STUDY00022060
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Inclusion Criteria:

• confirmed diagnosis of metastatic Stage IV NSCLC without specific genomic alterations
• if the tumor has a treatable mutation(s) (other than EGFR, ALK, or ROS1 genomic alterations), 1 additional line of therapy with the appropriate targeted therapy is required
• may be restricted from strenuous activity but walking and able to carry out work of a light or sedentary nature, e.g., light house work, office work
• patients of childbearing potential or those with partners of childbearing potential must be willing to practice an approved method of highly effective birth control during treatment and up to 12 months after all protocol-related therapy
• see link to clinicaltrials.gov for complete Inclusion and Exclusion criteria
Exclusion Criteria:

• on systemic steroid therapy ≥ 10 mg/day of prednisone or equivalent
• have any form of primary immunodeficiency
• had another primary cancer within the previous 3 years
Conditions: Cancer
Keywords: Clinics and Surgery Center (CSC), Metastatic Non Small Cell Lung Cancer, NSCLC
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A PHASE 2 STUDY OF ALISERTIB IN COMBINATION WITH ENDOCRINE THERAPY IN PATIENTS WITH HR+, HER2-NEGATIVE RECURRENT OR METASTATIC BREAST CANCER (ALISCA-Breast1)

The purpose of this study is to see if the study drug, called alisertib, in combination with an ‘endocrine therapy’ such as anastrozole, letrozole, exemestane, tamoxifen or fulvestrant can help people with HR+, HER2-negative recurrent or metastatic breast cancer. The study will also look at how well people tolerate treatment with alisertib in combination with one of the endocrine therapies that are commonly used in clinical practice.

Principal Investigator: Heather Beckwith
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: STUDY00023538
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Inclusion Criteria:

• diagnosis of adenocarcinoma of the breast that has reoccurred of spread to other areas of the body (metastatic)
• treatment with at least two prior lines of endocrine therapy in the recurrent or metastatic setting
• see link to clinicaltrials.gov for complete inclusion criteria
Exclusion Criteria:

• treatment with chemotherapy in the recurrent or metastatic setting
• see link to clinicaltrials.gov for complete exclusion criteria
Conditions: Cancer
Keywords: Clinics and Surgery Center (CSC), Breast Cancer, Hormone Receptor Positive HER-2 Negative Breast Cancer, Metastatic Breast Cancer
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A randomized, double-blind, placebo-controlled Phase 3 study of darolutamide plus androgen deprivation therapy (ADT) compared with placebo plus ADT in patients with high-risk biochemical recurrence (BCR) of prostate cancer (ARASTEP)

ADT is a systemic therapy called hormone therapy which reduces the androgen hormone (testosterone) levels to prevent prostate cancer cells from growing. This study is being done to learn more about a new drug called darolutamide given in combination with ADT for prostate cancer.

Principal Investigator: Emmanuel Antonarakis
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: SITE00001890
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Inclusion Criteria:

• diagnosis of adenocarcinoma of prostate
• treated with surgery and/or radiation therapy
• Serum testosterone 150 ng/dL or more
• see link to clinicaltrials.gov for complete inclusion and exclusion criteria
Exclusion Criteria:

• small cell, ductal or 50% or more component of neuroendocrine carcinoma of the prostate
• brain metastasis
• any other type of cancer (other than adequately treated basal cell or squamous cell skin cancer, superficial bladder cancer, or any other cancer in situ currently in complete remission) within 5 years
• study staff will review
Conditions: Cancer
Keywords: Prostate Cancer, Recurrent Prostate Cancer, Clinics and Surgery Center (CSC)
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COG AGCT1531 - A Phase 3 Study of Active Surveillance for Low Risk and a Randomized Trial of Carboplatin vs. Cisplatin for Standard Risk Pediatric and Adult Patients with Germ Cell Tumors

This partially randomized phase III trial studies how well active surveillance, bleomycin, carboplatin, etoposide, or cisplatin work in treating pediatric and adult patients with germ cell tumors. Active surveillance may help doctors to monitor subjects with low risk germ cell tumors after their tumor is removed. Drugs used in chemotherapy, such as bleomycin, carboplatin, etoposide, and cisplatin, 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.

Principal Investigator: Robin Williams
Age Group: Not specified
This study is NOT accepting healthy volunteers
IRB Number: SITE00000295
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Inclusion Criteria:

• newly diagnosed with a Stage I germ cell tumor or metastatic germ cell tumor
• see link to clinicaltrials.gov for detailed inclusion criteria
Exclusion Criteria:

• patients must have had no prior systemic therapy for the current cancer diagnosis
• patients must have had no prior radiation therapy (exception of CNS irradiation of brain metastases for standard risk 1 patients)
• female patients who are pregnant since fetal toxicities and teratogenic effects have been noted for several of the study drugs
• lactating females who plan to breastfeed their infants
• there are additional exclusion criteria (study staff will review)
Conditions: Cancer
Keywords: Germ Cell Tumor, Malignant Germ Cell Tumor
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Oxidative Stress Markers in Heart Failure II

This research is being done to better understand why people develop a type of heart failure where the heart contracts normally but does not relax well. By comparing levels of chemicals in the blood that are secreted by the body in subjects with normal hearts and in subjects with abnormal relaxation, we hope to gain a better understanding of why heart failure occurs.

Principal Investigator: Samuel Dudley
Age Group: 18 years and over
This study is also accepting healthy volunteers
IRB Number: STUDY00017627
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Inclusion Criteria:

• Looking for both healthy and diastolic dysfunction participants who have had an echo in the past 6 months
• Age greater than or equal to 18 years
• Transthoracic echocardiogram within 1 year prior to enrollment containing tissue Doppler, mitral inflow velocities, left ventricular ejection fraction and left ventricular end‐diastolic volume index data
• Able to provide written consent
• Healthy patients with an E/e’ ratio < 15
• Patients with asymptomatic diastolic dysfunction with an E/e’ ratio > 15
• Able to give a blood sample
• EF greater than or equal to 50%
Exclusion Criteria:

• EF<50%
• Any regional wall motion defects, any valvular heart disease with greater than a mild stenosis or regurgitation, any congenital or other significant structural heart disease,
• Patients undergoing cancer treatment
• Patients with an anticipated life expectancy less than 18 months.
• Age < 75 years
• Previous hospital admission for acute heart failure
• History of NYHA Class II, III or IV functional status
• The need for loop diuretics specifically for heart failure at any time.
• History of congestive heart failure.
• History of coronary artery disease.
• History of myocardial infarction.
• Significant structural heart disease
• Evidence of infiltrative cardiac disease
• Atrial fibrillation (AF) within 6 weeks
• Rhythm other than sinus at enrollment
• Patient with a pacemaker
• Cardiogenic shock
• History of heart transplant or left ventricular assist device
• Hemodialysis or peritoneal dialysis
• Active infection including bacteremia
• Major trauma or surgery within 6 weeks
• Collagen vascular disease if on active treatment including steroids and other immunomodulating drugs
• Systemic steroid use within 6 week.
Conditions: Heart & Vascular
Keywords: Clinics and Surgery Center (CSC), cMyBP-C, Heart failure, HFpEF, cardiac diastolic dysfunction (DD)
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A Phase 2 Randomized Trial of Neoadjuvant Enoblituzumab versus Standard of Care in Men with High-Risk Localized Prostate Cancer: The Help Elucidate & Attack Longitudinally (HEAT) Prostate Cancer Randomized Study (HEAT)

This study aims to improve prostate cancer treatment by testing a drug, enoblituzumab, which targets a protein called B7-H3. Previous research suggests it might boost the immune system to fight cancer. The objective is to see if it delays cancer return compared to standard treatment and identify who responds best.

Principal Investigator: Christopher Warlick, MD
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: STUDY00022418
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Inclusion Criteria:

• confirmed adenocarcinoma of the prostate
• an initial prostate biopsy within 3 months of enrollment is available for review, showing at least 3 positive cores, including one with ≥50% involvement and Gleason ≥8
• radical prostatectomy has been scheduled
• see link to clinicaltrials.gov for complete inclusion & exclusion criteria
Exclusion Criteria:

• known lymph node involvement on CT or distant metastases on CT or bone scan; non-adenocarcinoma prostate cancers
• previous or concurrent use of radiation, hormonal, biologic, chemotherapy, immunotherapy, experimental agents, 5α-reductase inhibitors, or systemic corticosteroids
• autoimmune diseases requiring systemic immunosuppression; malignancy within the last 3 years; uncontrolled major infections or illnesses
Conditions: Cancer
Keywords: Clinics and Surgery Center (CSC), Prostate Cancer
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Home-based Pulmonary Rehabilitation with Health Coaching in Patients with Fibrotic Interstitial Lung Disease: A Prospective Pragmatic Randomized Waitlist-Controlled Trial

This research study is for people who have a diagnosis of lung fibrosis and are experiencing increased shortness of breath from it. Participation involves being randomly (by chance) selected to participate in either the home-based rehab program right away or an observation only group. If randomly selected to participate in the observation group first, participants will be transitioned to the home-based rehab program after the observation period. Both programs last 12 weeks. The home-based rehab program involves the use of an electronic tablet containing video exercises that to complete daily for a total of 24 minutes of exercise each day. There is also a mindful breathing meditation that lasts about 3 minutes which you will do after completing the video exercises.

Principal Investigator: Hyun Kim
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: STUDY00024433
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Inclusion Criteria:

• fibrotic interstitial lung diseases (F-ILD) diagnosis, any disease subtype, active or prior medical treatment
• translators available for non- English speaking participants
Exclusion Criteria:

• unable to walk
• cognitive impairment or unable understand and follow instructions
• completed traditional center-based pulmonary rehabilitation within past 3 months
Conditions: Rare Diseases, Respiratory System
Keywords: f-ILD, Lung Fibrosis, Lung Interstitial Disease, pulmonary rehabilitation, Clinics and Surgery Center (CSC)
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NEPTUNE: The Nephrotic Syndrome Study Network - RDCRN Protocol 6801 (NEPTUNE)

Nephrotic syndrome is a condition which affects the kidneys causing them to leak protein from the blood into the urine. Nephrotic syndrome is a disease that can improve (remission) and worsen (relapse) at different times throughout childhood. By collecting health information and laboratory samples, our goal is to learn more about these kidney diseases and find better ways to prevent and treat people with nephrotic syndrome. New knowledge will be shared with researchers and the public.

Principal Investigator: Patrick Nachman
Age Group: Not specified
This study is NOT accepting healthy volunteers
IRB Number: SITE00000599
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Inclusion Criteria:

• Group A: up to 80 years of age with clinical diagnosis for FSGS/MCD or MN or pediatric participants who have protein in the urine and are scheduled for a kidney biopsy
• Group B: are less than 19 years old, have started immunosuppression drugs less than 30 days ago and have abnormal kidney lab values
Exclusion Criteria:

• prior solid organ transplant
• clinical diagnosis of glomerulopathy without diagnostic renal biopsy
• systemic lupus erythematosus (SLE)
• clinical evidence of other renal diseases
Conditions: Kidney, Prostate & Urinary
Keywords: Clinics and Surgery Center (CSC), Focal Segmental, Focal Segmental, Glomerulosclerosis, Glomerulosclerosis, Minimal Change Disease (MC
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Studies of Complex Auditory Perception

This study involves testing auditory and speech perception using behavioral and non-invasive physiological measures in humans.

Principal Investigator: Andrew Oxenham
Age Group: 18 years and over
This study is also accepting healthy volunteers
IRB Number: 1306S37081
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Inclusion Criteria:

• Native English speaker as all test materials are in English
Exclusion Criteria:

• Any neurological disorder diagnosis
Conditions: Ear, Nose & Throat
Keywords: Hearing, listening effort, speech understanding
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Prevalence of "funky" urine in lower urinary tract reconstruction utilizing bowel or catheter-based bladder management

This study is about improving our ability to characterize the prevalence of “funky” urine (i.e., urine with an abnormal odor, color, or appearance) in adults with either (1) a history of lower urinary tract reconstruction utilizing bowel and/or (2) catheter-based bladder management. We also aim to determine the frequency with which such patients receive antibiotic treatment for presumed urinary tract infections (UTIs). This may help us better understand how to help patients avoid unnecessary treatment with antibiotics.

Principal Investigator: Sean Elliott
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: STUDY00024754
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Inclusion Criteria:

• people who have catheter-based bladder management including an indwelling catheter (urethral or suprapubic, or a channel) or do intermittent clean catheterization OR
• have lower urinary tract reconstruction utilizing bowel including Ileal conduit, neobladder, bladder augmentation, or a catheter channel
• willing to share mobile phone number and use this for contact with the study team
Conditions: Kidney, Prostate & Urinary
Keywords: bladder, catheter, urine, Clinics and Surgery Center (CSC)
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Social Genomic Mechanisms of Health Disparities Among Adolescent and Young Adult (AYA) Survivors of Hodgkin and Non-Hodgkin Lymphoma

This study examines the impact of social and genetic factors on outcomes in adolescent and young adult (AYA) cancer survivors of Hodgkin or non-Hodgkin lymphoma.

Principal Investigator: Chaithanya Bhaskar
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: MMCORC089
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Inclusion Criteria:

• between the ages of 15-39 at the time of their first primary cancer diagnosis of Hodgkin lymphoma or non-Hodgkin lymphoma (NHL)
• completed therapy and had with a complete response
• last date of prior systemic therapy was no more than one year ago
• must be English speaking
• have internet access through computer, tablet, or smartphone and an email address
• at least able to do limited selfcare, may be confined to bed or chair more than 50% of waking hours
• see link to clinicaltrials.gov for complete inclusion criteria
Conditions: Cancer
Keywords: Hodgkin Lymphoma, Non-Hodgkin Lymphoma
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A Phase I Study of a Tropism Modified Conditionally Replicative Adenovirus Vector (RGDCRAdCOX2F) for Endoscopic, Direct-Tumor Delivery in Pancreatic Adenocarcinoma

This is an early study of a new drug, RGDCRAdCOX2F, as a single tumor injection in persons with adenocarcinoma of the pancreas. The main goal of the study is to find a safe dose of the study drug.

Principal Investigator: Edward Greeno, M.D.
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: STUDY00021119
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Inclusion Criteria:

• documented pancreatic adenocarcinoma that is confined to the pancreas and regional lymph nodes
• one prior line of therapy is permitted
• normal cardiac and pulmonary function
• participants with partners of childbearing potential must be willing to use at least two forms of effective birth control
• see link to clinicaltrials.gov for complete inclusion & exclusion criteria
Exclusion Criteria:

• women who are pregnant or breastfeeding
• other types of pancreatic cancer
• history of human immunodeficiency virus (HIV) infection
• history of or active acute or chronic active hepatitis B or C infection
• taking 10mg/day or more of prednisone for more than one week
Conditions: Cancer
Keywords: Clinics and Surgery Center (CSC), Adenocarcinoma of Pancreas, Pancreatic Cancer
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Cannabidiol (CBD) and Stress Response: Psychobiological Mechanisms

This study includes healthy adults between the ages of 21-70 who either use or do not cannabidiol (CBD) regularly. The purpose of this study is to learn about how CBD users and nonusers respond to stress. Participants must be willing to attend one in-person visit at the University of Minnesota Duluth campus

Principal Investigator: Mustafa al'Absi
Age Group: 18 years and over
This study is also accepting healthy volunteers
IRB Number: STUDY00024552
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Inclusion Criteria:

• 21 to 70 years old
• generally healthy
• use CBD regularly or do not use CBD
• willing to attend one in-person visit at the University of Minnesota Duluth campus
Exclusion Criteria:

• current, unstable physical or mental health condition
• women who are currently pregnant
• current use of illicit substances (other than cannabis)
Conditions: Heart & Vascular, Mental Health & Addiction, Prevention & Wellness
Keywords: Cannabidiol, CBD, stress
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A Phase 1 Study to Assess the Safety, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy of ACE-232 in Patients with Metastatic Castration-Resistant Prostate Cancer (CRPC)

The purpose of this research is to collect information about the safety and tolerability of the study drug ACE-232, along with how well it works to control metastatic castration-resistant prostate cancer (mCRPC).

Principal Investigator: Emmanuel Antonarakis
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: STUDY00024643
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Inclusion Criteria:

• diagnosis of Metastatic Castration-resistant Prostate Cancer (MCRPC) with - ongoing androgen deprivation therapy (ADT) or had bilateral orchiectomy
• difficult to treat or intolerant to standard treatment
• may be restricted in physically strenuous activity but able to walk and carry out work of a light or sedentary nature, e.g., light house work, office work
• see link to clinicaltrials.gov for complete inclusion criteria
Exclusion Criteria:

• spinal cord compression or known brain metastases
• severe cardiovascular disorders
• known gastrointestinal (GI) disorder or GI procedure
• poorly controlled diabetes
• active or uncontrolled autoimmune disease
• see link to clinicaltrials.gov for complete exclusion criteria
Conditions: Cancer
Keywords: Clinics and Surgery Center (CSC), MCRPC, Metastatic Castration-resistant Prostate Cancer, Prostate Cancer
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