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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.

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National Liver Cancer Screening Trial (TRACER)

Finding liver cancer early is important to increase chances of getting treatment and decreasing risk of dying from cancer. The purpose of this research is to compare the effectiveness of two liver cancer screening methods to detect liver cancer at an early stage. Participants will be randomly (by chance) placed in one of two study groups – one group will undergo ultrasound imaging of the liver with or without a blood test to measure a specific protein, whereas the second group will undergo a blood test for liver cancer screening called a GALAD score. The GALAD score combines three blood tests to screen for liver cancer. We do not currently know if GALAD would help detect liver cancer earlier than standard screening.

Principal Investigator: Elizabeth Aby
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: STUDY00023768
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Sex: Male or Female
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
Inclusion Criteria:

• 18 to 85 years old
• diagnosis of cirrhosis of the liver of any cause, or Hepatitis B
• physician has determined patient is eligible for for hepatocellular carcinoma (HCC) screening
Exclusion Criteria:

• history of liver cancer or clinical symptoms of liver cancer
• presence of another active cancer besides skin cancer
• history of organ transplant
• active listing for liver transplant
• history of alcohol related liver inflammation within 3 months
• known pregnancy at the time of consent
• active warfarin use
Conditions: Cancer
Keywords: HCC, hepatocellular carcinoma, Liver Cancer, Clinics and Surgery Center (CSC)
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Optimization of deep brain stimulation parameters in patients with medically refractory epilepsy

The purpose of this research is to better understand how deep brain stimulation settings can affect the electrical activity in the brain and the frequency of seizures. There are a number of different ways in which the deep brain stimulation electrodes can be programmed to stimulate the brain. This research study uses the implanted battery in the chest to record electrical activity from the brain at different stimulation settings. We then use this electrical activity to determine stimulation settings that are “personalized” to your brain.

Principal Investigator: Robert McGovern, MD
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: STUDY00011863
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Sex: Male or Female
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
Inclusion Criteria:
People who have medically refractory epilepsy with a deep brain stimulator in place
Exclusion Criteria:
People who have dementia of sufficient severity to impair their ability to make healthcare related decisions for themselves
Conditions: Brain & Nervous System
Keywords: Epilepsy, DBS, Deep Brain Stimulation
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Feasibility of Using a Conversational Agent for Promoting Smoking Cessation Treatment Utilization

This study is testing a new digital tool designed to help people who smoke during a quit attempt. The tool is a conversational program that uses artificial intelligence to provide personalized support and suggestions when people are facing situations where they might be more likely to smoke. The goal of the study is to see how easy the tool is to use, whether people find it helpful, and whether it may support smoking cessation.

Principal Investigator: Michael Kotlyar
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: STUDY00026782
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Sex: Male or Female
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
Inclusion Criteria:

• 21 years of age or older
• identify as Black or African American
• currently smoke cigarettes and meet minimum smoking requirements for the study
• willing to make a quit attempt within the next 30 days
• see link to ClinicalTrials.gov for complete inclusion criteria
Exclusion Criteria:

• current use of prescription nicotine medications requiring clinical monitoring
• medical conditions or medications that may significantly interfere with smoking behavior or study participation
• pregnant or breastfeeding
• see link to ClinicalTrials.gov for complete exclusion criteria
Conditions: Mental Health & Addiction
Keywords: nicotine, Smoking cessation
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Ostomy Simulation for Patient Education Prior to Urologic Bowel Diversion Surgeries

This research is being to see if a new 3D simulation model is helpful in teaching patients about care of their stomas after surgery. We expect that people will be in this research study for 3-6 months depending on the timing of surgery and postoperative visits. The number of preoperative and postoperative visits, physician exams, scans, X-rays, and laboratory tests for preparation for surgery or after the surgery does not change because of this study.

Principal Investigator: Hamed Ahmadi
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: STUDY00020255
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Sex: Male or Female
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
Inclusion Criteria:

• at least 18 years old
• having bowel diversion urologic surgery
Exclusion Criteria:

• prior or current ostomy
• women who are pregnant
• cognitively unable to care for own stoma
Conditions: Kidney, Prostate & Urinary
Keywords: bowel diversion urologic surgery, ileostomy, stoma
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MT2023-42: A Phase 1 Study of FT819 in B-Cell Mediated Autoimmune Diseases

This study will test the safety of FT819, an experimental cell product, in people with severe active systemic lupus erythematosus. The purpose of this study is to understand the way someone's body processes and responds to FT819, and to find out what effects FT819 may have on a person and their systemic lupus erythematosus.

Principal Investigator: Parastoo Fazeli
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: STUDY00020865
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Sex: Male or Female
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
Inclusion Criteria:

• between 18 and 40 years old
• diagnosed with Systemic Lupus Erythematosus (SLE)
• failure to respond to glucocorticoids and ≥2 of the following treatments for at least 3 months: cyclophosphamide (CY), mycophenolic acid or its derivatives, belimumab, methotrexate, azathioprine, anifrolumab, rituximab, obinutuzumab, cyclosporin, tacrolimus, or voclosporin
Exclusion Criteria:

• active neurological symptoms of SLE
• CNS disease such as stroke, epilepsy, or neurodegenerative disease in the past two years
• prior treatment with CAR T-cell therapy, allograft organ transplant, or hematopoietic stem cell transplant
Conditions: Immune Diseases
Keywords: Clinics and Surgery Center (CSC), SLE, Systemic Lupus Erythematosus
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Identification of Prodromal Neurodegeneration in Serotonergic-Induced REM sleep Behavior Disorder

This research is being completed to examine the cells, brain imaging, and speech in individuals with REM Sleep Behavior Disorder who are taking serotonergic medications such as Citalopram, Escitalopram, Fluoxetine, Fluvoxamine, Paroxetine and Sertraline. The purpose of examining these is to try and see if we can predict signs of Dementia with Lewy bodies (a progressive form of dementia with an increase in decline of thinking, reasoning, and other functions). This may benefit others by enabling us to diagnose Dementia with Lewy Bodies sooner rather than later.

Principal Investigator: Michael Howell
Age Group: 18 years and over
This study is also accepting healthy volunteers
IRB Number: STUDY00019626
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Sex: Male or Female
Age Group: 18 years and over
This study is also accepting healthy volunteers
Inclusion Criteria:

• 18 to 75 years old
• diagnosis of polysomnogram-confirmed RBD (e.g. narcolepsy) with history of dream enactment or clear dream enactment visualized on video from polysomnogram
• dream enactment began shortly after (less than 2 months) starting a serotonergic antidepressant medication
• for Healthy Volunteers: on serotonergic medication for at least 6 months without history of dream enactment
• the following serotonergic medications are included for both groups: Citalopram, Escitalopram, Fluoxetine, Fluvoxamine, Paroxetine, and Sertraline
Exclusion Criteria:

• Parkinsons disease, dementia with Lewy bodies, Multiple System Atrophy, Pure Autonomic Failure, Alzheimers disease, other diagnosed neurodegenerative disorder, or other known cause of RBD (e.g. narcolepsy)
• untreated obstructive sleep apnea, obesity hypoventilation, central sleep apnea or other sleep disordered breathing
• unable to have a MRI scan
• women who are pregnant
• for Healthy Volunteers: same exclusion criteria as those with 5-HT RBD group, plus history of dream enactment, or increased REM motor tone
Conditions: Rare Diseases, Brain & Nervous System
Keywords: aging, dream enactment, Serotonergic REM sleep behavior
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MT2024-43: A Phase 1 Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Activity of Single Ascending Doses of SBT777101 in Subjects with Rheumatoid Arthritis (Regulate-RA)

The study evaluates the safety and effects of a novel regulatory CARTreg cell-based autoimmune and inflammatory disease therapy for the treatment of rheumatoid arthritis. The therapy is an autologous (using the patient's own cells) Treg cell therapy that targets proteins in the inflamed, disease-associated tissue, with the aim to dampen inflammation and restore balance to the immune system.

Principal Investigator: Daniel Mueller
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: STUDY00023753
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Sex: Male or Female
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
Inclusion Criteria:

• adult-onset, moderate-to-severe rheumatoid arthritis (RA)
• Body mass index (BMI) <35 kg/m^2
• inadequate response to or unable to tolerate available RA therapies
• willing to use highly effective methods of contraception
• see link to clinicaltrials.gov for complete inclusion criteria
Exclusion Criteria:

• major surgery within 12 weeks prior to screening or planned within 12 months
• uncontrolled heart, lung, kidney, liver, endocrine, or gastrointestinal disease
• recurrent infections or active infection
• see link to clinicaltrials.gov for complete exclusion criteria
Conditions: Arthritis & Rheumatic Diseases, Immune Diseases
Keywords: Autoimmune, Clinics and Surgery Center (CSC), RA, Rheumatoid Arthritis
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COG APEC14B1 The Project: Every Child Protocol: A Registry, Eligibility Screening, Biology and Outcome Study Additional Title: EVERYCHILD (APEC14B1) PCR - COG Foundation

This research trial studies the Project: Every Child for younger patients with cancer. Gathering health information over time from younger patients with cancer may help doctors find better methods of treatment and on-going care.

Principal Investigator: Robin Williams
Age Group: Not specified
This study is NOT accepting healthy volunteers
IRB Number: SITE00000151
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Sex: Male or Female
Age Group: Not specified
This study is NOT accepting healthy volunteers
Inclusion Criteria:

• must be =< 25 years of age at time of original diagnosis, except for patients who are being screened specifically for eligibility onto a COG (or COG participating National Clinical Trials Network [NCTN]) therapeutic study, for which there is a higher upper age limit
• patients with a known or suspected neoplasm that occurs in the pediatric, adolescent or young adult populations
• enrollment must occur within 6 months of initial disease presentation OR within 6 months of refractory disease, disease progression, disease recurrence, second or secondary malignancy
• see link to clinicaltrials.gov for additional inclusion criteria
Conditions: Cancer
Keywords: childhood cancer
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MT2025-35 Allogeneic Hematopoietic Stem Cell Transplantation Using Reduced Intensity Conditioning Treosulfan and Fludarabine, with Post-Transplant Cytoxan (PTCy) for the Treatment of Hematological Diseases

This study is testing a stem cell (bone marrow) transplant for people with certain blood disorders. The goal is to find a treatment approach that is effective while causing fewer side effects. Participants will receive treatment to prepare their body, followed by a transplant using stem cells from a donor. After the transplant, they will receive medications to help prevent complications.

Principal Investigator: Christopher Graham
Age Group: Not specified
This study is NOT accepting healthy volunteers
IRB Number: STUDY00027522
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Sex: Male or Female
Age Group: Not specified
This study is NOT accepting healthy volunteers
Inclusion Criteria:

• up to 75 years of age
• have a matched related donor
• see link to clinicaltrials.gov for complete inclusion & exclusion criteria
Exclusion Criteria:

• women who are pregnant or breast feeding
• active central nervous system malignancy
• untreated active infection
• recent stem cell transplant within the past 3 months
Conditions: Blood Disorders, Cancer
Keywords: Clinics and Surgery Center (CSC), Hematological Diseases, Stem Cell Transplant
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A Phase 1, First-in-Human, Dose Escalation and Expansion Study to Evaluate the Safety and Tolerability of XmAb541 in Advanced Solid Tumors

This study is testing an investigational drug called XmAb541 for people with advanced solid tumors that test positive for a protein called CLDN6. XmAb541 is a type of immunotherapy designed to help the body's immune system recognize and attack cancer cells. The first part of the study will test different doses of XmAb541 to determine a safe and appropriate dose for future research. Once a recommended dose is identified, additional participants will receive that dose in the second part of the study. Researchers will evaluate the safety of XmAb541, how the body responds to the treatment, and whether it shows signs of helping to control or shrink cancer.

Principal Investigator: Melissa Geller, MD
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: STUDY00025913
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Sex: Male or Female
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
Inclusion Criteria:

• ovarian, fallopian tube, peritoneal, endometrial, uterine, or another CLDN6-positive cancer that has returned, spread, or not responded to previous treatment
• able to carry out most daily activities with limited assistance
• see link to ClinicalTrials.gov for complete Inclusion Criteria
Exclusion Criteria:

• active autoimmune disease
• significant heart, lung, or gastrointestinal disease
• active hepatitis B or hepatitis C infection
• see link to ClinicalTrials.gov for complete Exclusion Criteria
Conditions: Cancer
Keywords: Clinics and Surgery Center (CSC)
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Neuroplasticity in REM Sleep Behavior Disorder

REM sleep behavior disorder (RBD) is a condition in which people physically act out their dreams while sleeping. Some people with RBD may later develop neurological conditions such as Parkinson's disease or related disorders. This study will examine changes in the brain over a two-year period using advanced brain imaging (7T MRI) and other neurological tests. Researchers will compare people with RBD to people without the disorder to better understand how the brain changes over time and identify potential early signs of neurological disease.

Principal Investigator: Colum MacKinnon
Age Group: 18 years and over
This study is also accepting healthy volunteers
IRB Number: STUDY00016232
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Sex: Male or Female
Age Group: 18 years and over
This study is also accepting healthy volunteers
Inclusion Criteria:

• aged 21-75
• diagnosed with REM Sleep Behavior Disorder (RBD)
Conditions: Brain & Nervous System
Keywords: aging, RBD, REM Sleep Behavior Disorder
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Multicenter ALS Imaging Study

The purpose of the study is to test new biomarkers of ALS using MRI scans at 3 Tesla (3T). A biomarker is a measurable characteristic that can be used as an indicator of a particular disease state. Identifying biomarkers in ALS will help test new treatments and may help us make diagnoses earlier.

Principal Investigator: Pramod Pisharady
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: STUDY00021637
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Sex: Male or Female
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
Inclusion Criteria:

• for people who have Amyotrophic Lateral Sclerosis (ALS): less than 24 months since symptoms started, and diagnosis of probable or definite ALS
• for people with ALS and healthy volunteers: able to read, write and speak English, and able to have a MRI
Exclusion Criteria:

• any condition that makes MRI unsafe or if unable to comply with instructions
• healthy volunteers with clinically significant abnormal findings on neurological examination
Conditions: Brain & Nervous System, Rare Diseases
Keywords: MAIS, ALS, Amyotrophic Lateral Sclerosis, Primary Lateral Sclerosis, Clinics and Surgery Center (CSC)
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A Randomized Open-label Phase 2 Study of TALazoparib with or without ENzaluTamide in Patients with Metastatic Castration-Resistant Prostate Cancer and HRR Mutations After Progression on Abiraterone Acetate or Darolutamide (TALENT) (TALENT)

The purpose of this study is to find out whether a study drug called talazoparib, given alone or in combination with enzalutamide, can help slow down or delay the growth of prostate cancer in people whose cancer has spread and no longer responds to hormone therapy. This study includes people whose cancer has specific genetic changes and who have previously been treated with another prostate cancer medicine called abiraterone acetate.

Principal Investigator: Ian Okazaki
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: STUDY00026000
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Sex: Male
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
Inclusion Criteria:

• diagnosis of metastatic castration-resistant prostate cancer (mCRPC) with mutations in DNA repair genes involved in homologous recombination repair (HRR)
• cancer has progressed despite prior hormone-based treatment and shows ongoing disease activity
• ability to perform most daily activities
• see link to clinicaltrials.gov for complete inclusion criteria
Exclusion Criteria:

• prior treatment with certain prostate cancer therapies (such as PARP inhibitors or specific chemotherapy/targeted drugs)
• serious or uncontrolled medical conditions that could affect safety (such as uncontrolled heart disease, seizures, or brain/spinal metastases)
• see link to clinicaltrials.gov for complete exclusion criteria
Conditions: Cancer
Keywords: Clinics and Surgery Center (CSC), mCRPC, Metastatic castration-resistant prostate cancer
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Extracellular Vesicles as Potential Biomarkers and Therapeutic Target in Gaucher Disease (Le-Na)

This is an observational study intended to generate preliminary data to understand how lysosomal dysfunction can affect the biogenesis of extracellular vesicles, its content and function. The study entails 2 visits over a 3-month period. On enrollment, participants will be scheduled for the 2 visits, during which fasting blood samples will be collected.

Principal Investigator: Reena Kartha
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: STUDY00013672
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Sex: Male or Female
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
Inclusion Criteria:

• ages 18 to 80
• diagnosis of Gaucher Disease
Exclusion Criteria:

• hematological cancer or other uncontrolled medical conditions
Conditions: Rare Diseases
Keywords: Gaucher Disease
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Listening effort in people with hearing impairment

The purpose of this research is to understand the effort needed to understand speech if hearing is impaired. Listening effort is higher in people with hearing impairment and has wide-ranging negative consequences across many aspects of a person’s life. The goal of this project is to explore factors that make listening effortful, with special focus on the need to repair perceptual mistakes by relying on context.

Principal Investigator: Matthew Winn
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: STUDY00004150
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Sex: Male or Female
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
Inclusion Criteria:

• adults with one or two cochlear implants
Exclusion Criteria:

• non native English speakers
Conditions: Ear, Nose & Throat
Keywords: cochlear implant, hearing loss, listening
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Visual Perception in Visual Snow Syndrome

This study seeks to understand visual perception in people with Visual Snow Syndrome and how this relates to brain function.

Principal Investigator: Michael-Paul Schallmo
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: STUDY00014113
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Sex: Male or Female
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
Inclusion Criteria:

• Between 18 - 60 years old
• Good general physical health
• No history of other neurological disorders or problems
• Fluent in English
Conditions: Vision & Eyes
Keywords: Visual snow, visual snow syndrome
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Imaging Core Aim 2, and Udall Project 2 Aim 2

We are conducting this research to try to find a better way of treating Parkinson's disease, specifically postural instability and gait disturbances (PIGD) by looking at certain brain characteristics using 3T magnetic resonance imaging (MRI.) We think we could discover how to make DBS more effective for such things as postural gait instability and other symptoms of PD. Participants will be asked to come to our research location, walk on a treadmill, and have a 3T MRI.

Principal Investigator: Noam Harel
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: STUDY00016989
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Sex: Male or Female
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
Inclusion Criteria:

• at least 21 years old
• already have a MRI-compatible DBS device (Medtronic Percept/Percept RC DBS System) for treatment of Parkinson’s disease
• able to speak English
Exclusion Criteria:

• women who are pregnant
• extreme claustrophobia
• unable to have a MRI
Conditions: Brain & Nervous System
Keywords: DBS, Clinics and Surgery Center (CSC)
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Diaphragmatic Breathing Exercises for post-COVID-19 Diaphragmatic Dysfunction (DD)

There is evidence that dysfunction of the diaphragm following COVID infection that leads to the shortness of breath and chest tightness. The diaphragm is the main muscle of respiration. This study involves muscle stretching of the diaphragm and associated muscles to improve the quality of respiration. Half of the participants will receive PT twice a week, for 12 weeks, for 1 hour (in person) and a half hour via telehealth. A control group will undergo traditional treatment as recommended by your provider.

Principal Investigator: Farha Ikramuddin
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: STUDY00017641
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Sex: Male or Female
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
Inclusion Criteria:

• age 18 and above
• PCR positive 4 weeks prior to the development of the respiratory symptoms
• new diagnosis of PASC (new-onset symptoms of fatigue, shortness of breath, chest tightness or persistence of symptoms 4 weeks following a positive PCR test for COVID-19)
• did not need hospitalization of 5 days or more and did not need ICU admission
• nose breathers
• symptoms include shortness of breath, chest tightness, and fatigue
Exclusion Criteria:

• pre-existing lung disease such as COPD, IPF, Asthma, Exercise induced Asthma, Lung cancer, or history of Lung transplant
• history of current smoking and pack years of 10
• history of coronary artery disease
• general anxiety disorder
• unable to have full range of motion of the shoulders
• on antidepressants prior to covid-19 infection
• women who are pregnant
• unable to read and speak English
• previously diagnosed severe cognitive deficits such as dementia, developmental defects
• acute medical conditions, psychiatric disorders such as schizophrenia, mania, and psychosis, neurologic disorders such as stroke, Parkinson’s disease and Multiple sclerosis
Conditions: Respiratory System
Keywords: COVID-19, shortness of breath, cough
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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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Sex: Male
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
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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COgnitive STrategies in Early Psychosis 1 (COSTEP 1)

This study is about decision making in psychosis spectrum disorders, like schizophrenia. We will study how a single dose of a study agent called modafinil changes how people complete computer tasks and changes how the brain functions. We hope to improve our understanding of psychosis to help people in the future.

Principal Investigator: Sophia Vinogradov
Age Group: 18 years and over
This study is also accepting healthy volunteers
IRB Number: STUDY00025500
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Sex: Male or Female
Age Group: 18 years and over
This study is also accepting healthy volunteers
Inclusion Criteria:

• 18 to 35 years old
• speak English as primary language
Exclusion Criteria:

• major medical diagnosis such as neurological disorder, kidney, heart, liver disease
• people who are pregnant, breastfeeding, or planning to become pregnant
• have a diagnosis or immediate family history of a psychotic, bipolar, or autism spectrum disorder
• study staff will review additional criteria
Conditions: Mental Health & Addiction
Keywords: mental health

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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Sex: Male or Female
Age Group: 18 years and over
This study is also accepting healthy volunteers
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 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: Minneapolis, Twin Cities, UMN, Cannabidiol, CBD, stress
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Assessment of usability and satisfaction with a take-home device presenting sound and body stimulation for back pain

The purpose of this study is to measure the compliance, usability, and satisfaction of an at-home, multi-modal stimulation device in a diverse population of people with chronic lower back pain (cLBP) compared to a group of participants who are engaging in integrative health practices. The multi-modal device will include a combination of electrical stimulation, auditory stimulation, and integrative-health techniques, including mindfulness breathing, health coaching, and reflective journaling. The multi-modal device creation is based on prior knowledge in lower back pain treatment, which includes electrical stimulation of the back (Transcutaneous Electrical Nerve Stimulator or TENS) and integrative health modalities. Findings from this usability pilot study could help refine the approach and the multi-modal device for a future intervention study in cLBP participants.

Principal Investigator: Hubert Lim
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: STUDY00021883
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Sex: Male or Female
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
Inclusion Criteria:

• must have chronic lower back pain, defined as back pain lasting 3 or more months,
• willing to travel to the University of Minnesota and commit to the study duration
Exclusion Criteria:

• cannot have any implanted stimulation devices
Conditions: Bone, Joint & Muscle
Keywords: aging, Back Pain
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Senolytics To slOw Progression of Sepsis

Researchers hope that using Fisetin, an antioxidant, will reduce inflammation in the body caused by sepsis, which could help your body and organs have more time to recover. Placebo in this study will be something that looks similar to the study treatment, but does not contain any active drug. Everyone will receive 4 pills, but your group will determine how many of the pills are Fisetin. Researchers will look at the potential effects Fisetin or placebo has on inflammation in the body and how sick participants are at 7 days and 28 days.

Principal Investigator: Michael Puskarich
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: SITE00001869
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Sex: Male or Female
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
Inclusion Criteria:

• Age 65 or older
• Primary diagnosis of acute infection
• Expected length of hospital stay at least 48 hours
Exclusion Criteria:

• No acute infection
• Known hypersensitivity or allergy to Fisetin
• Not admitted to hospital
• Enrolled in another Sepsis clinical trial
Conditions: Infectious Diseases
Keywords: Fisetin, Sepsis
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teleABLE: Adapting a Behavioral Activation-Based Intervention to Reduce Post-Stroke Sedentary Behavior using Telehealth (Main Trial)

We are exploring ways to promote healthy lifestyles during stroke rehabilitation using a web-based rehabilitation program. The purpose of this study is to compare two intervention approaches: teleABLE and Healthy Lifestyles Education. Both interventions are delivered using video visits, so participants can complete all study activities from home

Principal Investigator: Emily Kringle
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: STUDY00021288
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Sex: Male or Female
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
Inclusion Criteria:

• at least 18 years old
• diagnosed with stroke more than 6 months ago
• report 6 or more hours of sedentary behavior on a typical day
• live in a community-based setting (i.e., personal residence, assisted living facility)
• mobile within the home, with or without an assistive device and without physical assistance
Exclusion Criteria:

• Stroke participants will be excluded if:
• currently receiving chemotherapy or radiation treatments for cancer
• have a medical diagnosis of neurodegenerative disorder (i.e., dementia, Parkinsons disease, multiple sclerosis, amyotrophic lateral sclerosis, glioblastoma)
• received inpatient treatment for substance use disorder or psychiatric condition within the past 12 months
• have a history of skin sensitivity related to adhesives
• pregnant or expecting to become pregnant in the next 2 months
• live in an institutional setting
• currently incarcerated
• stroke participants will also be excluded if they have severe aphasia
Conditions: Brain & Nervous System
Keywords: CVA, physical therapy, rehabilitation, remote, Stroke, virtual

D2D: Tyrannosaurus Flex: Finding the "Fair-ly Normal" Grip

How strong is your squeeze? We’re inviting kids aged 2-12 to test their grip and help us establish new standards for hand strength. Your contribution allows our team to create more inclusive, accurately calibrated technology that works for everybody. Stop by the Minnesota State Fair Research Building for a Tyrannosaurus Flex to help us find the Fair-ly Normal Grip and help us build the future of interactive play!

Principal Investigator: Corey McGee, PhD, MS, OTR/L, CHT
Age Group: Up to 18 years old
This study is also accepting healthy volunteers
IRB Number: STUDY00028771
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Sex: Male or Female
Age Group: Up to 18 years old
This study is also accepting healthy volunteers
Inclusion Criteria:

• ages 2-12 years old
Exclusion Criteria:

• musculoskeletal, neurological, or neuromuscular conditions affecting upper limb strength or function
• diagnosis of a systemic condition affecting the musculoskeletal or nervous system
• previous hand, wrist, or upper limb surgery
• history of hand, wrist, or upper limb trauma
• current pain in either hand or upper limb
Conditions: Arthritis & Rheumatic Diseases, Bone, Joint & Muscle, Brain & Nervous System
Keywords: Grip strength, hand function, MNFair
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I-SPY 2 TRIAL -Investigation of Serial Studies to Predict your Therapeutic Response with Imaging and Molecular Analysis 2 (I-SPY)

The I-SPY2 study uses 10 years of results to help your doctor understand more about your tumor and how to classify it better. This means your doctor will have more information and might be able to offer you a new treatment that could work better than the usual treatments. We need better treatments and better ways to identify which patients will benefit most from particular treatments.

Principal Investigator: Anne Blaes, MD
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: STUDY00011111
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Sex: Male or Female
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
Inclusion Criteria:

• invasive breast cancer confirmed by biopsy
• tumor is at least 2.5 cm in size
• no prior chemotherapy for this cancer
• no restrictions in activity or partially restricted with work, but able to independently care for self
• willing to have another breast biopsy
• not pregnant or breast feeding
• consult study staff for additional requirements
Exclusion Criteria:

• other medical or mental health diagnosis that would limit compliance with study requirements
Conditions: Cancer
Keywords: Breast Cancer, Breast Tumors, I-SPY, ISPY, ISPY2, Clinics and Surgery Center (CSC)

MT2024-13: First-in Cancer-Type Phase I Study of FT536 for Recurrent WHO Grade 4 Astrocytoma

The upfront treatment for astrocytoma is surgery, radiation therapy, and chemotherapy. There is currently no standard therapy for when the astrocytoma has returned (recurs) or re-grows (progresses). This study uses the investigational drug FT536, a cell therapy that stimulates the immune system into action to treat astrocytoma that has returned or regrown. FT536 is a type of cell therapy made up of “natural killer” or NK cells, a type of immune blood cell that are known to attack cancer cells. The primary purpose of this study is to identify a safe dose of FT536 cells when given as an intratumoral injection and to identify the side effects of treatment with FT536. Another purpose of this study is to understand how FT536 alters the immune system in the brain and body.

Principal Investigator: Elizabeth Neil
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: STUDY00027280
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Sex: Male or Female
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
Inclusion Criteria:

• 18 to 75 years old
• confirmed Grade 4 astrocytoma that has reoccurred or progressed
• completed usual antitumor treatment including surgery, radiation therapy, and temozolomide with or without Optune/ Tumor Treatment Fields (TTF)
• able to have MRI scans with contrast agent
• completely off or on a dose of dexamethasone 2mg daily or less with stable neurological function when starting the study
• must use a highly effective form of birth control from the first study visit until at least 3 months after the dose of FT536
• see link to clinicaltrials.gov for complete Inclusion criteria
Exclusion Criteria:

• prior treatment with bevacizumab or any other cellular therapy
• prior or current GammaTile, Gliadel wafer use, or other implanted therapeutic agent or photodynamic therapy
• women who are pregnant or breastfeeding
• history of another cancer in the past 5 years
• other significant medical or social conditions that would limit the ability to complete the study requirements
• see link to clinicaltrials.gov for complete Exclusion criteria
Conditions: Cancer
Keywords: Clinics and Surgery Center (CSC), Astrocytoma, Brain Cancer
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OptimICE-PCR: De-Escalation of Therapy in Early-Stage TNBC Patients Who Achieve pCR After Neoadjuvant Chemotherapy with Checkpoint Inhibitor Therapy

We are doing this study because we want to find out if observation is as good as the usual care for breast cancer. The usual approach for patients with early-stage triple-negative breast cancer (TNBC) who receive preoperative chemotherapy plus pembrolizumab is to continue to receive FDA-approved pembrolizumab for up to 27 weeks after surgery. Participants will either get pembrolizumab for up to 27 weeks, or will not receive any treatment and will be observed for up to 27 weeks. We will continue to follow participants every 6 months for 5 years and watch for side effects or cancer coming back. After that, participants will be checked every year for a total of 10 years after the study.

Principal Investigator: Anne Blaes, MD
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: STUDY00021547
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Sex: Male or Female
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
Inclusion Criteria:

• at least 18 years old
• able to walk and capable of all selfcare but unable to carry out any work activities; up and about more than 50% of waking hours
• no cancer remaining in the breast or lymph nodes after the completion of neoadjuvant therapy (complete response)
• Estrogen (ER) and progesterone (PR) no more than 10% and HER2-negative
• if cancer was present in both breasts, participation in the study is permitted as long as the eligibility criteria are met for both tumors/breasts
• must have received neoadjuvant chemotherapy in combination with pembrolizumab for a minimum of 6 cycles
• not pregnant and not nursing
• see link to clinicaltrials.gov for complete inclusion and exclusion criteria
Exclusion Criteria:

• stage IV (metastatic) breast cancer
• known active liver disease -medical conditions that require chronic systemic steroids (>10 mg prednisone daily or equivalent) or any other form of immunosuppressive medications and has required such therapy in the last two years
Conditions: Cancer
Keywords: Breast Cancer, TNBC, Triple Negative Breast Cancer, Clinics and Surgery Center (CSC)
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Phase I Study of Peptide Alarm Therapy (PAT) Administered by Intratumoral Injection with a PD-1/PD-L1 Inhibitor in Patients with Solid Tumor Cancers Who Have Failed Two Prior Therapies

This study is testing an “investigational” drug referred to as peptide alarm therapy (PAT) that was specially made for this study. PAT is using the peptide to stimulate the immune system for people who have failed prior treatment with a PD-1/PD-L1 inhibitor. Examples of PD-1/PD-L1 inhibitors are pembrolizumab (Keytruda), nivolumab (Opdivo), cemiplimab (Libtayo), atezolizumab (Tecentriq), avelumab (Bavencio), and durvalumab (Imfinzi). The goal of the 1st part of the study is to identify an acceptable, safe dose of PAT and up to 3 dose levels of PAT will be tested. If dose level 3 is reached without toxicity, it becomes the dose used for the next part of the study. In the 2nd part of the study, additional patients are treated at the PAT dose identified as safe in the 1st part to gain additional safety information and provide an initial estimate of anti-cancer effect.

Principal Investigator: Melissa Geller, MD
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: STUDY00015219
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Sex: Male or Female
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
Inclusion Criteria:

• positive for Cytomegalovirus (CMV) and Epstein–Barr virus (EBV
• failed prior treatment with a PD-1/PD-L1 inhibitor. Examples of PD-1/PD-L1 inhibitors are pembrolizumab (Keytruda), nivolumab (Opdivo), cemiplimab (Libtayo), atezolizumab (Tecentriq), avelumab (Bavencio), and durvalumab (Imfinzi).
• strenuous activity may be restricted; can do light work; able to walk
• people of childbearing potential or with partners of childbearing potential must be willing to abstain from heterosexual activity or use a highly effect form of contraception from the time of study enrollment until at least 4 months after the last dose study drug
• see link to clinicaltrials.gov for complete Inclusion criteria
Exclusion Criteria:

• women who are pregnant or breast feeding
• active metastases to the central nervous system
• active autoimmune disease that has required systemic treatment in the past 2 years
• history of bone marrow and/or solid organ transplant
• other active medical conditions
• see link to clinicaltrials.gov for complete Exclusion criteria
Conditions: Cancer
Keywords: Clinics and Surgery Center (CSC), metastasis, solid tumor
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A Phase 1 Study of JNJ-87189401 (PSMA-CD28 Bispecific Antibody) Combined with JNJ-78278343 (KLK2-CD3 Bispecific Antibody) for Advanced Prostate Cancer

The purpose of this study is to assess whether JNJ-87189401 given in combination with pasritamig (JNJ-78278343) to men with metastatic castration-resistant prostate cancer (also known as mCRPC) can cause side effects, and to find doses for the two drugs when given in combination. Side effects are unexpected or unwanted reactions from receiving the study drugs. Additionally, the study will look at how long JNJ-87189401 and pasritamig stay in the body, how they act on the body, and how the body responds to them.

Principal Investigator: Nicholas Zorko
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: STUDY00027319
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Sex: Male
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
Inclusion Criteria:

• confirmed adenocarcinoma of the prostate. Adenocarcinoma with small cell or neuroendocrine (NE) features is permitted
• Prior orchiectomy or medical castration; participants who have not undergone orchiectomy, must be receiving ongoing androgen deprivation therapy with a gonadotropin releasing hormone (GnRH) analog (agonist or antagonist)
• fully active, able to carry on all pre-disease performance without restriction or unable to do strenuous activity but walking and able to carry out work of a light or sedentary nature, e.g., light house work, office work
• see link to clinical trials.gov for complete Inclusion criteria
Exclusion Criteria:

• active autoimmune disease in the 12 months that requires systemic immunosuppressive medications (example, chronic corticosteroids, methotrexate, or tacrolimus)
• any of the following within past 6 months: myocardial infarction, severe or unstable angina, significant ventricular arrhythmias, congestive heart failure, transient ischemic attack (TIA), or Cerebrovascular accident (CVA, stroke)
• see link to clinicaltrials.gov for complete Exclusion criteria
Conditions: Cancer
Keywords: Clinics and Surgery Center (CSC), mCRPC, Prostate cancer
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