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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.

436 Study Matches

STOP PEDS RCT (Streamlined Treatment of Pulmonary Exacerbations in Pediatrics Randomized Controlled Trial) (STOP PEDS RCT)

In this study, we are going to compare two ways of treating mild respiratory illnesses in children with Cystic Fibrosis (CF). One is immediate antibiotics (increase airway clearance and start oral antibiotics right away) and the other is tailored therapy (increase airway clearance right away but only start oral antibiotics if symptoms worsen or do not improve). We are looking at how safe each option is and how well each one works. To do this, we will randomize participants (like flipping a coin) to one of these two approaches if a mild respiratory illness happens over the next 12 months.

Principal Investigator: Samuel Goldfarb
Age Group: Up to 18 years old
This study is NOT accepting healthy volunteers
IRB Number: STUDY00023173
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Sex: Male or Female
Age Group: Up to 18 years old
This study is NOT accepting healthy volunteers
Inclusion Criteria:

• Age: for main study group and non-HEMT group: age 6 to less than 19 years old OR for preschool group: age 3 to less than 6 years old
• diagnosis of Cystic Fibrosis (CF)
• for main study group and non-highly effective modulator therapy (HEMT) group, able to do spirometry
• able to receive text messages and access the internet
• see link to clincialtrials.gov for complete inclusion criteria
Exclusion Criteria:

• history of solid organ transplant
• positive culture for Mycobacterium abscessus in the prior 12 months
• three or more IV antibiotic-treated pulmonary exacerbations (PEx) in the prior 12 months
• treatment with chronic oral antibiotics other than azithromycin at enrollment
• see link to clinicaltrials.gov for complete exclusion criteria
Conditions: Children's Health, Respiratory System
Keywords: CF, Cystic fibrosis
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Vertical Sleeve Gastrectomy and Lifestyle Modification for the Treatment of Non-Alcoholic Steatohepatitis

This study is comparing the treatment of Non-Alcoholic Steatohepatitis (NASH) with either lifestyle changes or obesity surgery with lifestyle changes.  Participants must be 30-70 years old, have a BMI of 35.0-60.0 kg/m2, have health insurance that will pay for obesity surgery, and be willing to accept either treatment.

Principal Investigator: Sayeed Ikramuddin
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: STUDY00014879
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Sex: Male or Female
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
Inclusion Criteria:

• ages 30 to 70 years
• diagnosed with NASH with a total NAS >=4 including a ballooning score of at least 1, or diagnosed with T2DM or prediabetes, HbA1c < 9% Body Mass Index (BMI): 35.0-50.0 kg/m2
• willing to accept either surgery or life style changes
• must have insurance with no exclusion for obesity related treatments or management of obesity surgery complications. applies to all participants enrolled in the study
• evidence of liver fat present in the baseline MR images
• suitable for liver biopsy
Exclusion Criteria:

• cardiovascular event (myocardial infarction, acute coronary syndrome, coronary artery angioplasty or bypass, stroke) in the past six months
• pulmonary embolus or thrombophlebitis in the past six months
• cancer diagnosis unless disease free for five years
• alcohol intake more than one drink per day
• other physical or mental health disease (study staff will review)
Conditions: Digestive & Liver Health
Keywords: Bariatric Surgery, NASH, VSG, Clinics and Surgery Center (CSC), fatty liver, gastrectomy, sleeve, sleeve gastrectomy, weight loss
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Development and Validation of an MRI-Compatible Jaw Metabolic Stressor Task_Study1

The goal of this study is to develop and test a new way of measuring how much effort and strain the jaw muscles can handle before a person begins to feel specific levels of pain or fatigue. This involves a controlled jaw exercise task designed to better understand the relationship between jaw muscle effort, physical stress in the muscles, and how each person experiences discomfort. It is hoped that the information learned in this study will help researchers refine this new jaw testing method and confirm whether it accurately measures jaw muscle effort and discomfort. This may support future research that improves how jaw pain conditions are understood and eventually lead to better, more individualized treatments for people with jaw muscle and jaw joint disorders.

Principal Investigator: Estephan Moana-Filho
Age Group: 18 years and over
This study is also accepting healthy volunteers
IRB Number: STUDY00026440
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Sex: Male or Female
Age Group: 18 years and over
This study is also accepting healthy volunteers
Inclusion Criteria:

• Had a dental exam in the last year
• No significant body or mouth pain
Exclusion Criteria:

• Certain medical conditions (examples: autism, trigeminal neuralgia, pain conditions)
• Facial hair or significant skin darkening on the cheeks
Conditions: Dentistry
Keywords: Jaw function, JMS
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Standardized Microbiota Transplant Therapy in Crohn's Disease

The goal of this study is to determine if healthy donor microbes released in the small intestine act the same way as healthy donor microbes released in the large intestine for people with Crohn's Disease. We will see what good bacteria are present in intestinal biopsies at 8 weeks and look for improvement in inflammation with colonoscopy.

Principal Investigator: Byron Vaughn
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: STUDY00023114
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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 89 years old
• English speaking
• Diagnosis of Crohn's Disease (CD)
• currently experiencing a flare (Study will enroll people through 2027)
• Current CD therapies are in the maintenance phase of dosing
• Women who could become pregnant must remain abstinent or use a highly effective form of birth control (e.g., oral contraception, transdermal patch, barrier, intrauterine device)
• See link to clinicaltrials.gov for complete inclusion and exclusion criteria
Exclusion Criteria:

• Extensive bowel resection or ileostomy or colostomy
• Diagnosis of ulcerative colitis
• Women who are pregnant or breastfeeding
• History of anaphylactic food allergies
Conditions: Digestive & Liver Health
Keywords: Clinics and Surgery Center (CSC), Crohn's Disease, Fecal Microbiota, Gut bacteria, CD
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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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Development of Tobacco Related Biomarkers

To maintain a biorepository (sample bank) of biological samples from different tobacco users and non-users to investigate how tobacco and nicotine products affect our bodies. The samples will be used by researchers to develop methods to look for biological “markers” (biomarkers), or chemical changes in the body, that occur due to tobacco or nicotine exposure. The goal is to eventually use these biomarkers to improve detection, prevention, and treatment strategies for tobacco-related diseases.

Principal Investigator: Stephen Hecht, PhD
Age Group: 18 years and over
This study is also accepting healthy volunteers
IRB Number: STUDY00021394
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Sex: Male or Female
Age Group: 18 years and over
This study is also accepting healthy volunteers
Inclusion Criteria:
This study is currently recruiting healthy people who fit the following:
• formerly smoked cigarettes daily
• quit smoking in the last 2-10 years OR
• never used any tobacco products
Exclusion Criteria:

• younger than 21 years old
• unstable health condition
• use other tobacco products
Conditions: Community Health, Prevention & Wellness
Keywords: biomarkers, cigarettes, nicotine, smokeless tobacco, tobacco, former smoker, previous smoker, quit smoking
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A Randomized Phase III, Two-Arm Trial of Paclitaxel/Carboplatin/Maintenance Letrozole Versus Letrozole Monotherapy in Patients with Stage II-IV, Primary Low-Grade Serous Carcinoma of the Ovary or Peritoneum

We are looking at how well letrozole with or without paclitaxel and carboplatin works in treating patients with stage II-IV low-grade serous carcinoma of the ovary, fallopian tube, or peritoneum. Letrozole is an enzyme inhibitor that lowers the amount of estrogen made by the body and may stop the growth of tumor cells that need estrogen to grow. We will compare the effectiveness of the two different treatments.

Principal Investigator: Rahel Ghebre, Dr
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: MMCORC048
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Sex: Female
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
Inclusion Criteria:

• newly diagnosed, stage II-IV low-grade serous ovarian cancer fallopian tube or primary peritoneal cancers
• surgery for maximal cytoreduction completed within 8 weeks of randomization
• bilateral salpingo-oophorectomy completed
• able to take oral medications
Exclusion Criteria:

• prior neoadjuvant chemotherapy, endocrine therapy or radiotherapy for the treatment of this disease
• severe cardiac disease
Conditions: Cancer
Keywords: Fallopian Tube cancer, Ovarian cancer, Peritoneal cancer, Serous carcinoma
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A Randomized Double Blind Phase II Trial of Restorative Microbiota Therapy (RMT) or Placebo in Combination with Durvalumab (MEDI4736) and Tremelimumab With Chemotherapy in Treatment Naïve Advanced or Metastatic Adenocarcinoma Non-Small Cell Lung Cancer

The investigational therapy in this study is referred to as Restorative Microbiota Therapy (RMT). It is prepared by extracting healthy bacteria from the stool of healthy human donors and making it into capsules taken by mouth. The donor stool samples are rigorously tested for harmful bacteria and viruses before processing. There is scientific evidence to suggest that RMT might make immunotherapy more effective. The primary goal of the study is to test if RMT makes durvalumab + tremelimumab treatment with chemotherapy more effective to control lung cancer.

Principal Investigator: Manish Patel
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: STUDY00007800
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Sex: Male or Female
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
Inclusion Criteria:

• confirmed adenocarcinoma of the lung that is stage IIIB/C or stage IV that can't be surgically removed
• prior chemotherapy or immunotherapy as adjuvant therapy for lung cancer is permitted as long as it has been more than 6 months from last dose
• people who have treated brain metastasis are eligible as long as they have stable symptoms, are more than 2 weeks from completion of therapy, and do not require more than 10mg of daily prednisone or equivalent
• restricted in strenuous physical activity but can walk and carry out work of a light or sedentary nature, e.g., light house work, office work
• weigh at least 30 kg (66 lbs.)
• contact study staff for additional requirements
Exclusion Criteria:

• women who are pregnant or breast feeding
• unable to swallow medications
• additional medical and mental health diagnosis (study staff will review)
Conditions: Cancer, Respiratory System
Keywords: Clinics and Surgery Center (CSC), Adenocarcinoma of Lung, Lung Cancer
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A randomised, double-blind, placebo-controlled trial with an open-label extension to assess the pharmacokinetics, safety, and efficacy of empagliflozin tablets in paediatric patients with chronic kidney disease (EMPA-KIDNEY® Kids)

This study is for children aged 2 to 17 with chronic kidney disease (CKD). The purpose of this study is to find out if a study drug called empagliflozin helps children and adolescents with CKD. Other goals of the study are to find out how empagliflozin is tolerated and handled by the body in children and adolescents with CKD.

Principal Investigator: Michelle Rheault
Age Group: Up to 18 years old
This study is NOT accepting healthy volunteers
IRB Number: STUDY00027290
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Sex: Male or Female
Age Group: Up to 18 years old
This study is NOT accepting healthy volunteers
Inclusion Criteria:

• 2 to 17 years old
• Chronic kidney disease (CKD) of any type
• on a stable dose of maximally tolerated standard therapy for at least 30 days
• see link to clinicaltrials.gov for complete Inclusion criteria
Exclusion Criteria:

• Type 1 or Type 2 diabetes mellitus
• chronic dialysis or functioning kidney transplant or scheduled for transplantation
• Body mass index (BMI) ≤10th percentile for children ≥4 years of age and ≤25th percentile for children <4 years of age
• gastrointestinal disorders that might interfere withdrug absorption
• see link to clinicaltrials.gov for complete Exclusion criteria
Conditions: Kidney, Prostate & Urinary
Keywords: Chronic kidney disease, CKD
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Characterizing Neuropathic Pain in Individuals Receiving Inpatient Treatment for an Alcohol Use Disorder

This study aims to learn more about neurological symptoms associated with alcohol use. The study team plans to characterize neuropathic pain in individuals receiving in-patient treatment for alcohol use compared with moderate drinkers of the same age.

Principal Investigator: Jeff Boissoneault
Age Group: 18 years and over
IRB Number: STUDY00025425
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Sex: Male or Female
Age Group: 18 years and over
Inclusion Criteria:

• between 21 and 65 years of age
• must speak English
• Moderate drinkers group: Use alcohol at least 2-4 times per month
• Treatment group: patients in the Fairview Lodging Program primarily seeking treatment for alcohol - use of nicotine, cannabis, cocaine, and hallucinogens are permissible
Conditions: Brain & Nervous System, Mental Health & Addiction
Keywords: alcohol use, Pain, sensation
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Department of Neurology Movement Disorders Research Registry

The purpose of the University of Minnesota (UMN) movement disorders research registry is to connect individuals interested in participating in Movement Disorders research with researchers at the University of Minnesota. The registry will allow individuals from the community to share their contact information, basic information about their health diagnoses, and research studies they participate in. This information will be stored for future research contact and be used to determine which movement disorders studies (if any) that an individual may qualify for. Click 'Visit the Study Website' to learn more and to sign up for the registry.

Principal Investigator: Paul Tuite
Age Group: 18 years and over
This study is also accepting healthy volunteers
IRB Number: STUDY00027303
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Sex: Male or Female
Age Group: 18 years and over
This study is also accepting healthy volunteers
Inclusion Criteria:

• interested in participating in movement disorders research at UMN
Conditions: Brain & Nervous System
Keywords: Dystonia, movement disorders, Parkinson's, Tremor
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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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Improving Barriers to Care Access for Children with Autism and Related Needs via Telehealth for Evaluation, Care Navigating, and Caregiver Coaching

Researchers at the University of Minnesota, Twin Cities are looking for research participants for a study about the efficacy of early intervention services provided over telehealth (video conferencing) for kids ages 1-5 years old with Autism Spectrum Disorder (ASD) and their families. This study is also intended to test the training of community providers in the use of this model. Parents will receive coaching to provide interventions to support their child’s communication and other skills. You and your child may be eligible if your child is between 1 and 5 years old, your child is on a waitlist to be evaluated for ASD or has received an ASD diagnosis in the last 3 months & is waiting for services. Participants receive parent coaching 3x weekly for 9-12 weeks for 30-60 minutes over telehealth. Questionnaires and interviews are given before and after the intervention. Overall, parents commit to 18 months of participation.

Principal Investigator: Jessica Simacek
Age Group: 1 year and over
IRB Number: STUDY00022647
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Sex: Male or Female
Age Group: 1 year and over
Inclusion Criteria:

• children 1 to 5 years old
• waiting for either Autism Spectrum Disorder (ASD) diagnosis or intervention
• at least one caregiver (approved by the parent) willing to participate
Exclusion Criteria:

• determined by study staff following review of child's specific behaviors
Conditions: Brain & Nervous System, Children's Health, Community Health
Keywords: Autism, Care Navigation, Caregiver Coaching, Children, Evaluation, Intervention, Telehealth, ASD

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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Sex: Male or Female
Age Group: Not specified
This study is NOT accepting healthy volunteers
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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Identifying Impairments in Bilateral Coordination in Individuals Post-Stroke

Bilateral coordination (ability to use both arms) is poorly understood in stroke. We are using a robotic device to measure bilateral coordination in different tasks in individuals with chronic stroke and people of the same age who have not had a stroke.

Principal Investigator: Rachel Hawe
Age Group: 18 years and over
This study is also accepting healthy volunteers
IRB Number: STUDY00019059
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Sex: Male or Female
Age Group: 18 years and over
This study is also accepting healthy volunteers
Inclusion Criteria:

• Chronic stroke diagnosed at least 6 months ago
• at least 45 years old
• experiencing one-sided weakness (Hemiparesis)
• Healthy Participants: at least 45 years old, no known orthopedic or musculoskeletal difficulties
Exclusion Criteria:

• medical diagnosis of any neurodegenerative disorder.
• unable to move the upper limbs
• unable to follow simple instructions
• any impairments or severe pain that limits the movement of the upper limb
Conditions: Brain & Nervous System
Keywords: Arm Movement, CVA, Rehabilitation, Robotics, Stroke
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IMPACT: A Clinical Investigation on IMproving Peripheral Neuropathy Induced by Anti-Cancer Drugs with Advanced Compression Technology; A Safety and Efficacy Study (IMPACT)

The purpose of this study is to evaluate the effectiveness of investigational devices (the Lilac Glove and Lilac Boot devices) for the temporary reduction of moderate to severe symptoms of peripheral neuropathy caused by chemotherapy during the treatment of cancer. The Lilac Glove and Lilac Boot devices are designed to keep chemotherapy medication from damaging nerves. The study involves wearing the Lilac Glove and Boot devices on both hands and feet at each treatment session. Participants will be randomly assigned (like the flip of a coin) into one of two treatment groups; the “intervention group” (which means you receive treatment with the therapeutic Lilac devices) or the “control group” (which means you will receive treatment with the sham devices).

Principal Investigator: Melissa Geller, MD
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: STUDY00027329
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Sex: Male or Female
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
Inclusion Criteria:

• diagnosed solid tumor cancer, who will receive neo-adjuvant or adjuvant chemotherapy
• planned IV treatment with at least 4 cycles of chemotherapy, with no planned treatment pause for surgery
• willing to wear the Lilac Glove and Boot devices for the prescribed duration (devices to be fitted before infusion, and worn during infusion and for up to one (1) hours post infusion
• see link to clinicaltrials.gov for complete Inclusion criteria
Exclusion Criteria:

• baseline peripheral neuropathy of any kind
• chemotherapy in the previous 1 year
• any open wounds, sores, cysts or injury on the hands or on part of the upper arm where the device will be applied or on the feet or part of the lower leg where the device will be applied that may not be healed before chemotherapy starts
• untreated or uncontrolled hypertension
• poorly controlled diabetes
• weight greater than 140 kg (308 pounds)
• see link to clinicaltrials.gov for complete exclusion criteria
Conditions: Cancer
Keywords: Neuropathy, cancer, chemotherapy, Clinics and Surgery Center (CSC)
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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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Prefrontal Cortical Stimulation in Severe Treatment Resistant Depression

This study looks at the use of an implanted brain stimulator for people who have treatment resistant depression. The change in brain function by EEG and symptoms of depression will be examined. This study is open to people 22-70 years old with Medicare or Medicare Advantage insurance.

Principal Investigator: Ziad Nahas
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: STUDY00006945
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Sex: Male or Female
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
Inclusion Criteria:

• ages 22-55
• diagnosis of chronic (greater than or equal to 2 years) depression
• poor response to three or more antidepressant medications (staff will review)
• had or refused ECT therapy
• under the regular care of a psychiatrist
• enrolled in a Medicare program
• have at least two people over 22 years of age and live within 30 minutes of participants residence who could respond to study staff if needed
• able to have a MRI scan
Exclusion Criteria:

• actively suicidal or have a history of an attempt within the last year
• have a history of another major mental health diagnosis
• have a positive drug test
• have an implanted brain device
• pregnant
• history of seizures
Conditions: Mental Health & Addiction
Keywords: Clinics and Surgery Center (CSC), Chronic Depression, Depression
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An Open-label, Randomized, Controlled Phase 3 Study of Disitamab Vedotin in Combination with Pembrolizumab Versus Chemotherapy in Subjects with Previously Untreated Locally Advanced or Metastatic Urothelial Carcinoma that Expresses HER2 (IHC 1+ and Greater)

We’re studying disitamab vedotin to find out what its side effects are and if it works for urothelial cancer when given with pembrolizumab. We want to see if these drugs work better together than the available approved treatments.

Principal Investigator: Gautam Jha
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: STUDY00018433
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Sex: Male or Female
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
Inclusion Criteria:

• confirmed locally advanced unresectable or metastatic urothelial cancer (UC) including that originating from the renal pelvis, ureters, bladder, or urethra
• able to receive cisplatin- or carboplatin-containing chemotherapy
• 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.gov for complete inclusion and exclusion criteria
Exclusion Criteria:

• history of or active autoimmune disease that has required systemic treatment in the past 2 years
• prior solid organ or bone marrow transplantation
• pleural effusion or ascites with symptoms or requiring symptomatic treatment
Conditions: Cancer
Keywords: Urothelial Carcinoma
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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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Sex: Male or Female
Age Group: 18 years and over
This study is also accepting healthy volunteers
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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The Parallel Auditory Brainstem Response

This study aims to test the accuracy and speed of the pABR for future clinical use by recruiting infants and adults with a range of hearing loss profiles from normal hearing to severe loss.

Principal Investigator: Melissa Polonenko
Age Group: Up to 18 years old
This study is also accepting healthy volunteers
IRB Number: SITE00001873
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Sex: Male or Female
Age Group: Up to 18 years old
This study is also accepting healthy volunteers
Inclusion Criteria:

• 0-5 months of age
Conditions: Ear, Nose & Throat
Keywords: electrophysiology, Hearing, Hearing loss, Listening, audible
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RANDOMIZED PHASE III TRIAL OF MFOLFIRINOX +/- NIVOLUMAB VS. FOLFOX +/- NIVOLUMAB FOR FIRST-LINE TREATMENT OF METASTATIC HER2-NEGATIVE GASTROESOPHAGEAL ADENOCARCINOMA

This study compares the effect of modified fluorouracil, leucovorin calcium, oxaliplatin, and irinotecan (mFOLFIRINOX) to modified fluorouracil, leucovorin calcium, and oxaliplatin (mFOLFOX) for the treatment of advanced, unresectable, or metastatic HER2 negative esophageal, gastroesophageal junction, and gastric adenocarcinoma. Adding irinotecan to the FOLFOX regimen could shrink the cancer and extend the life of patients with advanced gastroesophageal cancers.

Principal Investigator: Edward Greeno, M.D.
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: MMCORC061
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Sex: Male or Female
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
Inclusion Criteria:

• HER2 negative unresectable or metastatic adenocarcinoma of esophagus, gastroesophageal junction, or stomach
• have not received any prior treatment for this occurrence
• prior neoadjuvant or adjuvant cytotoxic chemotherapy or adjuvant immunotherapy is allowed as long as it was completed at least 1 year ago
• see link to clinicaltrials.gov for complete Inclusion criteria
Exclusion Criteria:

• women who are pregnant or breastfeeding
• untreated, symptomatic brain metastasis
• allogeneic tissue/organ transplant
• see link to clinicaltrials.gov for complete Exclusion criteria
Conditions: Cancer
Keywords: Esophageal cancer, Gastric cancer
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MT2022-60: A phase II study of Pembrolizumab+ BEAM conditioning regimen before autologous stem cell transplant (ASCT) followed by pembrolizumab maintenance in patients of relapsed classic Hodgkin lymphoma

This drug study aims to estimate at initiation of treatment to the occurrence of disease progression or expiration at 1 years post autologous stem cell transplant of classical Hodgkin’s lymphoma patients treated with BEAM autologous stem cell transplant combined with pembrolizumab given pretransplant and for 1 year post-transplant maintenance.

Principal Investigator: Sanjal Desai
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: STUDY00020893
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Sex: Male or Female
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
Inclusion Criteria:

• eligible for autologous stem cell transplant (ASCT) with BEAM conditioning regimen
• unable to do strenuous activities but can walk and perform light or sedentary tasks, such as housework or office work
• see link to clinicaltrials.gov for complete inclusion and exclusion criteria
Exclusion Criteria:

• known active central nervous system (CNS) disease
• history of or active autoimmune disease, or other syndrome that requires systemic steroids or autoimmune agents
• had an allogenic tissue/solid organ transplant
• women who are pregnant or breast feeding
Conditions: Cancer
Keywords: Clinics and Surgery Center (CSC), Autologous Stem Cell Transplant, Classic Hodgkin Lymphoma
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Role of Nitric Oxide (NO) in Endothelial Dysfunction in Premenopausal Women with Posttraumatic Stress Disorder (PTSD)

This research study is being done so that we can better understand why women with post-traumatic stress disorder (PTSD) may have higher risk of cardiovascular disease as they get older. This study looks at how trauma and PTSD affect blood vessels in young women. The study is also testing whether a dietary supplement called beetroot juice might help improve the function of blood vessels in women suffering from PTSD. Study participation involves coming to the University of Minnesota campus in Minneapolis for two visits. Each of the visits with take about 3 and a half hours.

Principal Investigator: Ida-Arlaine Fonkoue
Age Group: 18 years and over
This study is also accepting healthy volunteers
IRB Number: STUDY00027129
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Sex: Female
Age Group: 18 years and over
This study is also accepting healthy volunteers
Inclusion Criteria:

• Adults >18 years old and <40 years
• Women
• Premenopausal
• Trauma-exposed
• PTSD
Exclusion Criteria:

• Hypertension
• Any cardiovascular disease
• Medications for cardiovascular diseases
• Any gastrointestinal diseases
Conditions: Women's Health
Keywords: Posttraumatic stress disorder (PTSD), Premenopausal women, Trauma: Mental Health, Heart Health

Neural Mechanisms of Closed-loop Phase-locked Transcranial Magnetic Stimulation

We are investigating ways to improve methods of brain stimulation. The purpose of this study is to try a new way to deliver transcranial magnetic stimulation (TMS) to the brain. Participants will be asked to come in for three separate 4-hour research visits. Each research visit will take place approximately seven days after the previous one. During the research visits, we will put a mesh cap on the head to measure electrical activity in the brain (also known as an EEG). Once the cap is on, we will use a transcranial magnetic stimulation (TMS) device to deliver small pulses of electricity to the brain to see how it reacts to the stimulation.

Principal Investigator: Alik Widge
Age Group: 18 years and over
This study is also accepting healthy volunteers
IRB Number: STUDY00020385
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Sex: Male or Female
Age Group: 18 years and over
This study is also accepting healthy volunteers
Inclusion Criteria:

• adults (Age 18 to 65) without any psychiatric diagnoses
• adults (Age 18 to 65) with depression diagnosis
Exclusion Criteria:

• diagnosed with a psychiatric disorder other than depression
• potential contraindications to EEG (e.g. visible scalp abrasions, non-removable hair extensions and/or hair styling that would impede proper EEG recording)
• potential contraindication to TMS (as identified by the TMS safety screener)
• any previous adverse reaction to TMS or MRI
• diagnosed with epilepsy or previously experienced a seizure
• diagnosed with a neurological condition, such as stroke or tinnitus
• experienced a head trauma that was diagnosed as concussion
• current use of or recent withdrawal from medications that can increase the risk of seizure
• currently pregnant
• any metal in the head (excluding mouth) or an implanted medical device
Conditions: Mental Health & Addiction
Keywords: brain stimulation, EEG, healthy control, TMS, transcranial magnetic stimulation, depression
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A Phase 3 Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Maridebart Cafraglutide on Mortality and Morbidity in Participants Living With Obesity and Heart Failure (MARITIME-HF)

This study is being done to learn more about maridebart cafraglutide (MariTide [formerly AMG 133]) for people with heart failure (HF) and obesity in addition to their routine medical care. Participants will receive treatment with either MariTide or a placebo, which will be called a study drug. A placebo looks the same as the investigational medicine but contains no actual medicine.

Principal Investigator: Tamas Alexy
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: STUDY00026740
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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 years
• BMI ≥ 30 kg/m2 at screening
• diagnosis of heart failure
• NYHA Class II-IV
• left ventricular ejection fraction of of at least 40%
• see link to clinicaltrials.gov for complete Inclusion criteria
Exclusion Criteria:

• Type 1 diabetes
• acute or chronic hepatitis
• history of unstable major depressive disorder or other severe psychiatric disorder within 2 years prior, any prior suicide attempt, or history of self injury in past 5 years
• see link to clinicaltrials.gov for complete Exclusion criteria
Conditions: Heart & Vascular
Keywords: body mass index (BMI) 30 kg/m2, Clinics and Surgery Center (CSC), heart failure (HF) with preserved or mildly reduced EF, obesity
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Detecting Ovarian Cancer by Analyzing Volatile Organic Compounds (VOCs) in Human Breath

The purpose of this study is to evaluate the ability of a device (Vocxi Health’s MyBreath Print®) to capture and measure volatile organic compounds (VOCs) in breath samples from women who have a pelvic mass and will be having surgery. The ultimate goal is to develop a screening test for ovarian cancer. We expect that study will take approximately 45 minutes and breath samples will be obtained before and after surgery.

Principal Investigator: Jordan N Mattson
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: STUDY00022603
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Sex: Female
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
Inclusion Criteria:

• women who have a pelvic mass and will have surgery
• diagnosis of ovarian, fallopian tube or primary peritoneal cancers or women with a non-malignant ovarian mass (excluding low malignant potential tumors)
• no prior history of cancer
Exclusion Criteria:

• unable to tolerate normal breathing while wearing device mask
Conditions: Cancer
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A Phase 1b/2a Double Blind, Placebo Controlled Study to Evaluate the Safety, Tolerability, Pharmacodynamics, and Efficacy of CNP-103 in Participants Ages 12-35 with Recent Onsetn Stage 3 Type 1 Diabetes

The main purpose of this study is to see how safe and tolerable CNP-103 is for people with type 1 diabetes. CNP-103 is a nanoparticle (a tiny particle) containing special beta cell proteins. In each group of adults and teens, participants will be assigned by chance (like flipping a coin) to receive either CNP-103 or placebo (like CNP-103 but contains salt water). Participants will have a 66% chance of receiving CNP-103 and a 33% chance of receiving placebo. The total duration of participation from the first Screening visit until the last assessment is approximately 208 days.

Principal Investigator: Antoinette Moran
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: STUDY00024994
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Sex: Male or Female
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
Inclusion Criteria:

• 12 to 35 years old
• women who are not pregnant or breastfeeding
• diagnosis of Type 1 Diabetes (T1D) within 180 days prior to study enrollment
• if on any medication used to treat the symptoms of T1D (e.g., corticosteroids), must be on a stable dose for at least 1 month before starting the study
• see link to clinicaltrials.gov for complete Inclusion criteria
Exclusion Criteria:

• diabetic ketoacidosis (DKA) at the time of diagnosis of T1D
• see link to clinicaltrials.gov for specific criteria related to the previous use of certain drugs
Conditions: Diabetes & Endocrine
Keywords: T1D, Type 1 Diabetes
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MN CF Center Consent (PortCF) Cystic Fibrosis (CF) Center Program Accreditation and Funding

This retrospective, longitudinal project is to collect certain demographic and clinical health status information for entry into the CF Foundation Patient Registry (also known as PortCF). The registry has played an important role in CF research and will continue to do so. In addition, much of the same information is entered into the University of Minnesota Cystic Fibrosis Center Research Database. This patient database has been maintained since 1975.

Principal Investigator: Sarah Kiel
Age Group: Not specified
This study is NOT accepting healthy volunteers
IRB Number: 7405M00054
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Sex: Male or Female
Age Group: Not specified
This study is NOT accepting healthy volunteers
Inclusion Criteria:

• possible diagnosis of Cystic Fibrosis (CF) or CF-related complications
• receive care at the MN CF Center
Keywords: Clinics and Surgery Center (CSC), cystic fibrosis, CF, MNCF
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Save the Bottoms!!!: Assessing the Gay Male Experience with Anal Cancer Prevention Strategies

The purpose of this study is to describe current knowledge and opinions about anal cancer screening among men who have sex with men (MSM), as well as their experience receiving guideline-compliant care aimed at anal cancer risk reduction using a large-scale survey disseminated via social media.

Principal Investigator: Elliot Arsoniadis
Age Group: 18 years and over
This study is also accepting healthy volunteers
IRB Number: STUDY00017257
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Sex: Male
Age Group: 18 years and over
This study is also accepting healthy volunteers
Inclusion Criteria:

• 18 years of age or older
• AMAB (Assigned Male at Birth)
• Current resident of the U.S.
• Engage in receptive anal intercourse with male partners
• Fluent in English or Spanish
Conditions: Cancer, Prevention & Wellness
Keywords: Anal Cancer
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