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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.

394 Study Matches

Hepatic Energy Fluxes, NASH, and Vertical Sleeve Gastrectomy

This study is looking at the liver function of people who have bariatric surgery. People who want to be in this trial must be obese, have abnormal liver function tests & prediabetes or type 2 diabetes. The study includes assistance with diet and exercise for a year after surgery.

Sayeed Ikramuddin
18 years and over
This study is NOT accepting healthy volunteers
STUDY00006269
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Inclusion Criteria:

• age 18 to 67 years
• diagnosis of non-alcoholic steatohepatitis (NASH)
• Body Mass Index (BMI) 30.0-55.0 kg/m2
• willing to have surgical treatment and have insurance with no exclusion for obesity related treatments or management of obesity surgery complications
• live or work within approximately three-hour traveling time from the study clinic for the duration of the one-year trial
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)
Digestive & Liver Health
Clinics and Surgery Center (CSC), Bariatric surgery, NASH, fatty liver, gastrectomy, gastric sleeve, sleeve, sleeve, VSG, weight loss
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Genetics of Developmental Disorders - Data and Specimen Repository

This project is a data and specimen repository for developmental disorders. Participants provide biological samples and permission to store their health-related data. The purpose is collect and manage these materials for use in biomedical research related to developmental disorders.

Williams Dobyns
Not specified
This study is NOT accepting healthy volunteers
STUDY00011194
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Inclusion Criteria:

• All ages
• Individuals with a developmental disorder (mostly but not exclusively developmental brain disorders)
• Parents and other selected relatives of individuals with developmental disorders
Brain & Nervous System, Rare Diseases, Children's Health
Genetic disorders, developmental brain disorders, developmental disorders
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Genetic Modifiers and Glycemic Variability in Turner Syndrome

This study is looking at glucose (blood sugar) patterns in participants with Turner Syndrome between the ages of 3-80 years old. This will be done by obtaining 2 hours frequent blood sampling by completing an Oral Glucose Tolerance Test and a Mixed Meal Tolerance Test. Participants will also wear a continuous glucose monitor for 2 weeks. Along with the OGTT and MMTT, participants are asked to provide a blood sample for DNA and RNA testing. Participant’s parents are asked to provide a saliva sample for DNA testing

Kyriakie Sarafoglou
Not specified
This study is NOT accepting healthy volunteers
STUDY00013812
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Inclusion Criteria:

• Participants with a diagnosis of Turner syndrome by karyotype
• Ages 3 to 80
Exclusion Criteria:

• Additional genetic diagnosis detected on karyotype, CMA, or FISH
• Prior diabetes diagnosis
• Current or recent (last 72 hours) use of systemic glucocorticoids
• Current use of hypoglycemic agents
• History of solid organ or bone marrow transplant
• Currently pregnant
• Non English-speaking
Diabetes & Endocrine, Rare Diseases
Turner Syndrome
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Antimicrobial Stewardship Community Awareness and Acceptance in Minnesota

This is a community-based study engaging diverse Minnesota adults aged >=18 years. The goal is to understand the public's acceptance and awareness of antimicrobial resistance and stewardship efforts and subsequently look at electronic educational methodology to increase antimicrobial stewardship public engagement.

Beth Thielen
18 years and over
This study is also accepting healthy volunteers
STUDY00019421
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Inclusion Criteria:
Adults >/= 18 years and able to understand written English
Exclusion Criteria:
None
Community Health, Infectious Diseases, Microbiota
Antibiotic resistance, public health
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Visual Surround Suppression and Perceptual Expectation Under Psilocybin

Psilocybin is the perception-altering drug found in ‘magic mushrooms’ and we want to learn more about visual perception in people taking psilocybin and how these relate to brain functions. Participants will be given an investigational study drug during 2 visits and asked to come in for a total of 7 study visits. Participants will also be required to refrain from using recreational drugs while enrolled in the study, including, but not limited to, hallucinogens, ketamine, and marijuana.

Jessica Nielson
18 years and over
This study is also accepting healthy volunteers
SITE00000856
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Inclusion Criteria:

• 25-65 years of age
• have at least a high school education (GED ok) and able to speak and write English
• experience taking psilocybin
• in good physical and mental health with BMI between 20.0 and 28.0 kg/M2
• have someone who can drive to study sessions at the University of MN
• live within 1 hour driving distance of the University of MN
• agree not to use any recreational drugs while in the study ( for example, hallucinogens, ketamine, and marijuana)
Exclusion Criteria:

• current or past history of a mental health issue
• currently taking any prescription medications on a daily basis, except birth control pills
• pregnant or breast feeding
• can't have a MRI
Mental Health & Addiction
psilocybin, visual perception
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Stress Response and Opioid Dysfunction in Nicotine Dependence

This study includes healthy adults between 18-70 years old who are either non-smokers or cigarette smokers interested in quitting. The purpose of this study is to learn more about how people respond to stress and to taking one dose of a widely and safely used drug called naltrexone as well as to learn about how these responses relate to whether or not someone smokes, smoking cessation, and smoking relapse.

Mustafa al'Absi
18 years and over
This study is NOT accepting healthy volunteers
STUDY00008687
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Inclusion Criteria:

• Live in Minnesota.
• Between 18-70 years old.
• Generally healthy.
• Want to quit using tobacco and nicotine.
• Are willing to attend up to 11 online (videoconference) study visits over a period of approximately 4 months (though you may be asked to complete the last visits over a period of up to 1 year).
Exclusion Criteria:

• Do not live in Minnesota.
• Not between 18-70 years old.
• Not willing to attend to up to 11 online (videoconference) study visits over a period of approximately 4 months.
Heart & Vascular, Mental Health & Addiction, Prevention & Wellness
cigarette, nicotine, quit smoking, smoker, smoking, smoking cessation, stress, tobacco
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MT2022-41 A Phase 1/2 Study Evaluating the Safety and Efficacy of a Single Dose of Autologous CD34+ Base Edited Hematopoietic Stem Cells (BEAM-101) in Patients with Sickle Cell Disease and Severe Vaso-Occlusive Crises (BEACON Trial) (BEACON)

BEAM-101 is an experimental new therapy being developed for treating people with SCD and vaso-occlusive crises. The goal of this study is to see if BEAM-101 is safe and effective for people in the study. The study sponsor and study doctors would also like to see if individuals who are treated with BEAM-101 require fewer blood transfusions and experience fewer vasoocclusive crises requiring hospitalization, compared to before they received BEAM-101. This study will also measure the levels of fetal hemoglobin along with measures that assess quality of life and ability to function following treatment with BEAM-101.

Ashish Gupta
18 years and over
This study is NOT accepting healthy volunteers
STUDY00017341
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Inclusion Criteria:

• 18 to 35 years old
• documented diagnosis of sickle cell disease with specific genotypes (study staff will review)
• disease is severe
Exclusion Criteria:

• HbF levels >20%, obtained at the time of screening on or off hydroxyurea therapy
• previous transplant
• history of an overt stroke
Rare Diseases, Blood Disorders
Clinics and Surgery Center (CSC), SCD, Sickle Cell Disease
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A multicenter, single arm, open-label trial to evaluate efficacy and safety of oral, twice daily iptacopan in adult PNH patients who have Hb >=10 g/dL in response to anti-C5 antibody and switch to iptacopan

The purpose of the study is to find out if iptacopan is effective and safe in adult patients with Paroxysmal Nocturnal Hemoglobinuria (PNH) who switch from their current standard of care treatment (eculizumab or ravulizumab) to iptacopan.

Joan Beckman
18 years and over
This study is NOT accepting healthy volunteers
STUDY00018020
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Inclusion Criteria:

• diagnosis of Paroxysmal Nocturnal Hemoglobinuria PNH)
• hemoglobin level at least 10 g/dL
• on a stable regimen (dose and intervals) of anti-C5 antibody treatment (either eculizumab or ravulizumab) for at least 6 months
Exclusion Criteria:

• needed red blood cell transfusion in the past 6 months
• history of stem cell transplant or solid organ transplant
• Human immunodeficiency virus (HIV) infection (known history of HIV or test positive for HIV antibody)
• history of cancer of any part of the body within the past 5 years
Rare Diseases
Clinics and Surgery Center (CSC), Paroxysmal Nocturnal Hemoglobinuria, PNH
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HM2022-48: A Phase 1/2 Dose Escalation Study of the BCL-2 Inhibitor ZN-d5 and the Wee1 Inhibitor ZN-c3 in Subjects with Acute Myeloid Leukemia

This study is being performed to determine the safety and tolerability of ZN-c3 alone and the combination of ZN-c3 and ZN-d5 in Acute Myeloid Leukemia (AML). We want to identify the best doses of the study drugs and learn if either drug effects the blood levels of the other. We will also assess how effective the Study Drugs are in treating AML and explore whether certain aspects of AML can predict whether leukemia responds to the study drug(s).

Mark Juckett
18 years and over
This study is NOT accepting healthy volunteers
STUDY00017682
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Inclusion Criteria:

• adults with Acute Myeloid Leukemia (AML) (including secondary or therapy-related), relapsed from or refractory to one or more prior lines of therapy
• able to walk and do selfcare but unable to carry out any work activities; up and about more than 50% of waking hours
• women of childbearing potential must not be pregnant and must use effective birth control during the study and for 6 months after the last dose of study drugs
• men must agree to use a condom when having intercourse during the study and for 3 months after the last dose of study drugs
Exclusion Criteria:

• active central nervous system (CNS) involvement
• significant cardiovascular disease
• active hepatitis B or hepatitis C infection
• additional exclusion criteria (study staff will review)
Cancer
Clinics and Surgery Center (CSC), Acute Myeloid Leukemia, AML
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See this study on ClinicalTrials.gov

MT2023-42: A Phase 1 Study of FT819 in Participants With Moderate to Severe Active Systemic Lupus Erythematosus

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.

Parastoo Fazeli
18 years and over
This study is NOT accepting healthy volunteers
STUDY00020865
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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
Immune Diseases
Clinics and Surgery Center (CSC), SLE, Systemic Lupus Erythematosus
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HEALEY ALS Platform Trial

The HEALEY ALS Platform Trial is a research trial that tests the safety and effectiveness of multiple treatments in ALS. A regimen is a specific course of treatment, each with a different study drug. We are doing this research to find out if different treatments have an effect on Amyotrophic Lateral Sclerosis (ALS). We also want to find out if these treatments are safe to take without causing too many side effects.

David Walk
18 years and over
This study is NOT accepting healthy volunteers
SITE00000881
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Inclusion Criteria:

• 18 years or older
• diagnosed with sporadic or familial ALS
• weakness started no more than 36 months ago -able to to swallow pills and liquids
Exclusion Criteria:

• unstable medical or mental health condition
• limitations on prior or current use of certain medications (study staff will review)
• women who are pregnant or breast feeding
Rare Diseases, Brain & Nervous System
Clinics and Surgery Center (CSC), ALS, amyotrophic lateral sclerosis
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Role of Pharmacotherapy in Counteracting Weight Regain in Adolescents with Severe Obesity

In this study we want to find out more about weight loss and how diet and medications can affect weight loss. This study will last for up to 58 weeks. There are two phases to the study: - A weight loss phase with prescribed meals that lasts 6 weeks. - A study medication/placebo phase that lasts up 52 weeks. You will not know if you are receiving the medication or the placebo.

Aaron Kelly
Up to 18 years old
This study is also accepting healthy volunteers
STUDY00008743
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Inclusion Criteria:

• severe obesity (BMI >/= 120% of the 95th percentile or BMI >/= 35 kg/m2)
• 12 to less than 18 years of age at enrollment
• female participants who are sexually active with males and who are able to get pregnant must agree to use two forms of contraception throughout the trial
Exclusion Criteria:

• diabetes (type 1 or 2)
• current or recent (< six months prior to enrollment) use of anti-obesity medication(s) (use of naltrexone or bupropion alone is not an exclusion)
• previous metabolic/bariatric surgery
• current use of a stimulant medication
• history of glaucoma
• current or recent (<14 days) use of monoamine oxidase inhibitor
• history of treatment with growth hormone
• history of bulimia nervosa
• major psychiatric disorder
• any history of active suicide attempt
• history of suicidal ideation or self-harm within the previous 30 days
• current pregnancy or plans to become pregnant during study participation
• current tobacco use
• history of cardiac, endocrine, kidney disease (study staff will review)
Children's Health, Diabetes & Endocrine
Clinics and Surgery Center (CSC), Obesity, overweight, weight loss
I'm interested
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See this study on ClinicalTrials.gov

MT2021-11: An Open-label, Single-arm, Multicohort, Phase 2 Study to Assess the Efficacy and Safety of Tabelecleucel in Subjects with Epstein-Barr Virus-associated Diseases

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

Joseph Maakaron
Not specified
This study is NOT accepting healthy volunteers
STUDY00013494
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Inclusion Criteria:

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

• women who are breastfeeding or pregnant
• currently active Burkitt, T-cell, natural killer/T-cell lymphoma/LPD, Hodgkin, plasmablastic, transformed lymphoma, active hemophagocytic lymphohistiocytosis, or other malignancies requiring systemic therapy
• serious known active infections
• additional exclusion criteria apply (study staff will review)
Cancer, Infectious Diseases
Clinics and Surgery Center (CSC), Epstein-Barr Virus (EBV)
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See this study on ClinicalTrials.gov

R01HL153613: Comprehensive Proteomic Classifier for the Molecular Characterization of Pulmonary Sarcoidosis

This study proposes to collect lung fluid to identify potential biomarkers associated with pulmonary sarcoidosis.

Maneesh Bhargava
18 years and over
This study is NOT accepting healthy volunteers
SITE00001283
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Inclusion Criteria:

• age 18-80
• contact umnsarc@umn.edu for inclusion/exclusion criteria
Exclusion Criteria:

• history/current use of cigarette, e-cigarette, vaping or marijuana smoking
• history/current use of nicotine products
• presence of underlying chronic condition
• inability to undergo procedure using IV sedation
• weight < 110 lbs. & BMI > 35 kg/m2
• pregnant and/or breast feeding
• history/current use of chronic immunosuppressive medications
• contact umnsarc@umn.edu for inclusion/exclusion criteria
Breathing, Lung & Sleep Health, Respiratory System
Sarcoid, Lung, Pulmonary, Sarcoidosis, Clinics and Surgery Center (CSC)
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Increasing HPV vaccination coverage among pediatric, adolescent, and young adult (PAYA) cancer survivors: A multilevel intervention

The purpose of this research is to test the efficacy of different interventions to increase vaccination against human papillomavirus (HPV). Survivors of childhood, adolescent and young adult cancers are at increased risk of developing HPV-associated secondary cancers, but have lower HPV vaccination coverage compared to the general population. Interventions which are found to be successful in this study will be incorporated into future survivorship care to improve adherence to recommend preventive healthcare practices. All research procedures will be conducted remotely (e.g. online).

Deanna Teoh
Not specified
This study is NOT accepting healthy volunteers
STUDY00013006
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Inclusion Criteria:

• current patient in the University of Minnesota CCSP clinic or the Children's Minnesota Long-Term Follow-up (LTFU) Program clinic
• seen in the CCSP clinic who do not have a history of cancer but who have received immunosuppressive therapy or HSCT for treatment of a hematologic disorder
• survivor of childhood cancer (diagnosed with cancer at age 25 years or younger) who is currently 18-26 years of age OR a caregiver of a survivor of childhood cancer who is currently 9-17 years of age
• at least 6 months post-treatment (current treatment for graft-versus-host disease allowed)
• no previous HPV vaccination or incomplete HPV vaccination
• people who are unsure of their HPV vaccination status and are unable to find vaccination records (study staff will review)
Exclusion Criteria:

• previously completed HPV vaccination series
• unable to read and write in English
• pregnant or plans to become pregnant in the next year
• currently receiving treatment for cancer or hematologic disorder or plan for treatment in next 12 months
• immediate hypersensitivity reaction to any vaccine component (study staff will review)
Cancer, Children's Health
Clinics and Surgery Center (CSC), cancer survivors, HPV, vaccination
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See this study on ClinicalTrials.gov

Robotic Gait Training to Improve Functional Outcomes after SCI

We are researching the benefits of physical therapy guided exoskeleton gait training in people with a spinal cord injury. We want to describe the benefits to overall function and how the brain changes after gait training.

Leslie Morse
18 years and over
This study is NOT accepting healthy volunteers
STUDY00018674
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Inclusion Criteria:

• spinal cord injury level C7-T12
• medically stable, no acute issues that would prevent gaiting
• motor complete (AIS A or B) spinal cord injury OR motor incomplete (AIS C or D) spinal cord injury who use a wheelchair for more than 50% of personal mobility
• height between 155-191cm (5'1" to 6'2")
• weight less than 113kg (248 pounds)
• sufficient upper body strength to complete sit-to-sit transfers
• women of childbearing age must agree to use contraception during study participation
Exclusion Criteria:

• women who are pregnant
• symptomatic orthostatic hypotension
• active Grade 2 or greater pressure ulcer that can be potentially worsened by use of an exoskeleton
• lower extremity contractures that interfere with wearing an exoskeleton
• unhealed lower extremity fracture
• history of neurologic diseases (e.g. stroke, peripheral neuropathy, myopathy)
• active treatment for epilepsy or thyroid disorders
• women with osteoporosis at baseline by DXA scan
Brain & Nervous System
Clinics and Surgery Center (CSC), Spinal Cord Injury (SCI)
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Study in Parkinson Disease of Exercise Phase 3 Clinical Trial: SPARX3 (SPARX3)

The purpose of this study is to compare the effects of 2 different levels of exercise intensity and to learn more about effects of aerobic exercise for people with Parkinson’s disease (PD). This study will help us better understand what exercise guidelines should be used in the future.

Colum MacKinnon
18 years and over
This study is NOT accepting healthy volunteers
SITE00001163
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Inclusion Criteria:

• 40 to 80 years old
• diagnosis of idiopathic Parkinson Disease (PD)
• less than 3 years since disease diagnosis
Exclusion Criteria:

• currently being treated with PD medications such as levodopa or dopamine receptor agonists, monoamine oxidase-B (MAO-B) inhibitors, amantadine, or anticholinergics
• expected to start medication within six months of starting the study
• previous use of medications for PD for more than 60 days
• exercising at greater than moderate intensity for 120 minutes or more per week consistently over the last 6 months
• known cardiovascular, metabolic, or renal disease or individuals with major signs or symptoms suggestive of cardiovascular, metabolic, or renal disease without medical clearance to participate in the exercise program
• uncontrolled hypertension (resting blood pressure greater than 150/90 mmHg)
• any medical, mental health, drug or alcohol abuse, assessment or laboratory abnormality that indicates a problem that could limit ability to participate in the exercise program (study staff will evaluate)
• women who are breast-feeding, pregnant, or plan to become pregnant in the next 12 months
• unable to have a brain scan
Brain & Nervous System
Clinics and Surgery Center (CSC), Parkinson Disease, Parkinson's Disease
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Efficacy of Belimumab and Rituximab Compared to Rituximab Alone for the Treatment of Primary Membranous Nephropathy (REBOOT)

People with Primary MN lose more protein in their urine because the filters in their kidneys may be damaged. It is possible that some belimumab may also be lost in the urine because of this. This study will measure belimumab in the blood to decide if people with high urine protein should receive a higher dose of belimumab. Another purpose of this study is to help learn about whether the combination of belimumab and rituximab treatment is effective in making and keeping Primary MN inactive.

Patrick Nachman
18 years and over
This study is NOT accepting healthy volunteers
STUDY00006831
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Inclusion Criteria:

• 18 to 75 years old
• diagnosis of Membranous Nephropathy (MN) or Nephrotic Syndrome (study staff will review specific requirements)
• hypertension while on maximum medications i.e. systolic BP greater than 140mmHg or diastolic greater than 90mmHg
Exclusion Criteria:

• Rituximab use within the previous 12 months
• poorly controlled diabetes mellitus defined as hemoglobin A1c (HbA1c) 9.0% or greater
• women of child-bearing age who are pregnant, nursing, or unwilling to be sexually inactive or use FDA-approved contraception for the duration of the study
• additional medical and mental health exclusions apply, study staff will review
Kidney, Prostate & Urinary
Clinics and Surgery Center (CSC), Membranous Nephropathy, Nephrotic Syndrome
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DegenPRO: A multicenter prospective registry for the management of degenerative spine disorders

This registry will be used to gather specific information about patients diagnosed with a degenerative spine disorder. Patient registries are observational studies that focus on understanding how the treatments, tests, and services, that are used in routine clinical care and by specialists, affect patient health outcomes. A registry that is appropriately designed, conducted, and analyzed will provide unique scientific information about the effectiveness, safety, and quality of the health-care service or intervention that is being studied.

Christopher Martin
18 years and over
This study is NOT accepting healthy volunteers
STUDY00000102
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Inclusion Criteria:

• diagnosed with a degenerative spine disorder and receiving treatment
Bone, Joint & Muscle
Clinics and Surgery Center (CSC), Degenerative Diseases, Spinal Cord
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See this study on ClinicalTrials.gov

Corrona Inflammatory Bowel Disease (IBD) Registry

This is a prospective, non-interventional, research study for patients with IBD under the care of a certified gastroenterologist. The primary objective for this registry is to prospectively study the natural history of IBD, the prevalence and incidence of comorbidities, targeted adverse events, and more, via questionnaires.

Eugenia Shmidt
18 years and over
This study is NOT accepting healthy volunteers
STUDY00007736
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Inclusion Criteria:

• at least 18 years old
• Diagnosis of one of the following by a gastroenterologist: Crohn's disease or Ulcerative colitis (UC)
• users of an approved biologic drug or JAK inhibitor (Tofacitinib) for the treatment of UC or Crohn's disease
Exclusion Criteria:

• Participating in or planning to participate in a clinical trial studying new medications for Crohn's disease or Ulcerative colitis
Digestive & Liver Health
Clinics and Surgery Center (CSC), Crohn's disease, Ulcerative colitis
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A Phase 1/2 Study of the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of Relatlimab Plus Nivolumab in Pediatric and Young Adult Participants with Recurrent or Refractory Classical Hodgkin Lymphoma and Non-Hodgkin Lymphoma Protocol Number: CA224069 (RELATIVITY-069)

CA224069 is an open-label, Phase 1/2 clinical trial of relatlimab + nivolumab in children, adolescents and young adults with Recurrent or Refractory Classical Hodgkin Lymphoma (R/R cHL) and Non-Hodgkin Lymphoma (NHL). Part A will encompass safety and dose determination of relatlimab + nivolumab. Part B will be composed of an expansion cohort of cHL (Cohort 1) and an exploratory assessment in NHL (Cohort 2).

Peter Gordon
Not specified
This study is NOT accepting healthy volunteers
SITE00001545
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Inclusion Criteria:

• up to 30 years old
• pathologically confirmed high-risk recurrent/relapsed or refractory (R/R) classical Hodgkin lymphoma (cHL), after non-response to or failure of first-line standard therapy prior to a definitive therapy e.g.high-dose chemotherapy/autologous stem cell transplant (HDCT/ASCT)
• participants with pathologically confirmed R/R NHL after failure or non-response to second line therapy, including but not limited to primary mediastinal B-cell lymphoma, diffuse large B-cell lymphoma (DLBCL), mediastinal gray zone lymphoma (MGZL), anaplastic large cell lymphoma (ALCL), or peripheral T-cell lymphoma (PTCL)
Exclusion Criteria:

• aggressive B-cell lymphomas subtypes including Burkitt lymphoma (BL), lymphoblastic lymphoma, and NK/T-cell lymphoma/leukemia
• prior autologous stem cell transplantation (HDCT/ASCT)
• see link to clinicaltrials.gov for additional exclusion criteria
Cancer
Hodgkin Disease, Lymphoma, Non-Hodgkin
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VX21-522-001: A Phase 1 Single Dose Escalation Study Evaluating the Safety and Tolerability of VX-522 in Subjects 18 Years of Age and Older With Cystic Fibrosis and a CFTR Genotype Not Responsive to CFTR Modulator Therapy

This is a clinical research study exploring the safety and tolerability of a single dose of VX-522 for people with cystic fibrosis (CF) who are not expected to benefit from CFTR modulators.

Joanne Billings
18 years and over
This study is NOT accepting healthy volunteers
SITE00001585
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Inclusion Criteria:

• 18 to 65 years old
• Stable cystic fibrosis disease
• FEV1 at least 40%
• Specific CFTR gene mutations
Exclusion Criteria:

• Uncontrolled asthma in the last year
• Oxygen saturation without oxygen therapy is >94%
• Severe liver disease
Rare Diseases, Breathing, Lung & Sleep Health
Cystic Fibrosis, CF
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See this study on ClinicalTrials.gov

BEGIN-OB-19: A Prospective Study to Evaluate Biological and Clinical Effects of Significantly Corrected CFTR Function in Infants and Young Children (BEGIN) (BEGIN)

This is a study of highly effective CFTR modulators and their impact in children with CF on endocrine growth factors, the gut microbiome, respiratory microbiome, liver and pancreatic function, lung function, sweat chloride, and inflammatory markers.

Elissa Downs
Up to 18 years old
This study is NOT accepting healthy volunteers
SITE00000975
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Inclusion Criteria:

• For Part A: less than 5 years of age at the first study visit
• For Part B: participated in Part A OR less than 6 years of age at the first study visit, CFTR mutations consistent with FDA labeled indication of highly effective modulator therapy and physician intends to prescribe ivacaftor or elexacaftor/tezacaftor/ ivacaftor
• Documented diagnosis of Cystic Fibrosis (CF)
Exclusion Criteria:

• use of ivacaftor or elexacaftor/tezacaftor/ ivacaftor within the 180 days
• use of an investigational drug within 28 days prior to first study visit
• use of chronic oral corticosteroids within the 28 days prior to first study visit
Rare Diseases
Cystic Fibrosis
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Building Resilience in Adrenoleukodystrophy with Imaging and Neuropsychology (BRAIN)

This study is about a genetic condition called Adrenoleukodystrophy (ALD). The first goal of this study is to understand more about how ALD affects a child’s brain and development in childhood as they take part in medical care and monitoring. This is important to identify the optimal ways to detect and treat manifestations of ALD such as cerebral ALD. The second goal is to learn about how ALD affects caregivers, so that clinicians can offer better support to families in the future. We will also have healthy comparisons to help to learn more about the condition (ALD) being studied, by comparing the information collected to a child without the condition.

Rene Pierpont
Up to 18 years old
This study is also accepting healthy volunteers
STUDY00016246
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Inclusion Criteria:

• 3 to 15 years old
• male
• diagnosis of ALD either at-risk for ALD: patients with genetically or biochemically-diagnosed ALD who currently have no evidence of cerebral disease on MRI and b) Cerebral ALD: boys with the cerebral form of ALD who underwent or are undergoing evaluation or treatment for this condition and have early stage disease
• for healthy volunteers: males between 3 and 15 years old
Exclusion Criteria:

• girls are excluded because this is a genetic disease that only males get
• history of a genetic, neurological, or neurodevelopmental disorder affecting brain development
• history of significant brain insult, infection or injury
Brain & Nervous System, Children's Health, Rare Diseases
Healthy control, children, pediatrics, adolescents
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Minnesota KPMP CKD and Resilient Diabetes Recruiting Site (KPMP)

The Kidney Precision Medicine Project (KPMP) is a research study. Our goal is learn more about kidney injury and kidney disease. By studying your kidneys, we may learn more about why chronic kidney disease happens and how to treat it more effectively or even how to prevent it. Or participants have had diabetes for many years and have not clinical signs of chronic kidney disease. By studying your kidneys, we may learn more about the factors that help protect you from kidney disease. KPMP will last for at least 10 years.

Patrick Nachman
18 years and over
This study is NOT accepting healthy volunteers
SITE00001290
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Inclusion Criteria:

• at least 18 years old
• diagnosis acute or chronic kidney (renal) disease with diabetes mellitus (type 1 or 2) OR associated with hypertension
• persistent kidney damage based on specific lab values at least 3 months apart (study staff will review)
Exclusion Criteria:

• Body Mass Index (BMI) greater than 40 kg/m2
• any allergic reaction to iodinated contrast
• receiving chemotherapy or radiation to treat cancer
• transplant recipient (includes solid transplant and bone marrow)
• unwilling to receive blood transfusion (if needed)
• women who are pregnant
Kidney, Prostate & Urinary
Clinics and Surgery Center (CSC), Acute Kidney Failure, Acute Kidney Insufficiency, Acute Renal Failure, Chronic Kidney Disease
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MT2019-01: Adrenoleukodystrophy National Registry Study (ALD) and Biobank

The purpose of this research to enhance our understanding of adrenoleukodystrophy ALD and study biospecimens such assaliva, blood, urine and stool to identify potential biomarkers for early identification of dise. We invite people who have or are at risk to have ALD, including females who are known or at risk carriers of the mutation for ALD, to help us learn more.

Ashish Gupta
Not specified
This study is NOT accepting healthy volunteers
STUDY00003605
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Inclusion Criteria:

• age 0 to 100
• patient or family member diagnosed with ALD (confirmed by positive VLCFA testing and/or genetic mutation
• patient or family member with known or presumed mutation with ALD based on pedigree or confirmed mutation in ABCD1 gene
• living in the United States and territories
Exclusion Criteria:

• have undergone BMT or other cellular therapy
• not fluent in English who are unable to consent in-person
• people who are unable to read or write
Rare Diseases
Adrenoleukodystrophy, ALD, Cerebral Adrenoleukodystrophy
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Effects of ziltivekimab versus placebo on morbidity and mortality in patients with heart failure with mildly reduced or preserved ejection fraction and systemic inflammation. (HERMES)

We are looking at a new drug called 'ziltivekimab' to see if it can be used to treat people living with heart failure and inflammation. People will get either ziltivekimab or a placebo (inactive dummy drug). The study drug is an injection given into the fold of the skin on the stomach, thigh or upper arm once every month. People will take the study drug for up to 4 years.

Les Forgosh
18 years and over
This study is NOT accepting healthy volunteers
SITE00001919
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Inclusion Criteria:

• at least 18 years old
• diagnosis of heart failure
• hospitalization or urgent/unplanned visit with a primary diagnosis of decompensated heart failure which required intravenous diuretic treatment, within the last 9 months prior to starting the study
• left ventricular ejection fraction (LVEF) greater than 40% documented by echocardiogram in the past year
• contact study staff for additional requirements
Exclusion Criteria:

• myocardial infarction, stroke, unstable angina pectoris, transient ischemic attack, or heart failure hospitalization within 30 days
• planned cardiac procedures (ablation, revascularization
• primary pulmonary hypertension, chronic pulmonary embolism, severe pulmonary disease including COPD etc.)
• women who are pregnant, breast-feeding or planning to get pregnant during the study period.
• contact study staff for additional exclusion criteria
Heart & Vascular
Heart Failure
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COG ARST2031: A Randomized Phase 3 Trial of Vinorelbine, Dactinomycin, and Cyclophosphamide (VINO-AC) Plus Maintenance Chemotherapy with Vinorelbine and Oral Cyclophosphamide (VINO-CPO) vs Vincristine, Dactinomycin and Cyclophosphamide (VAC) plus VINO-CPO Maintenance in Patients with High Risk Rhabdomyosarcoma (HR-RMS)

his phase III trial compares the safety and effect of adding vinorelbine to vincristine, dactinomycin, and cyclophosphamide (VAC) for the treatment of patients with high risk rhabdomyosarcoma (RMS). High risk refers to cancer that is likely to recur (come back) after treatment or spread to other parts of the body. This study will also examine if adding maintenance therapy after VAC therapy, with or without vinorelbine, will help get rid of the cancer and/or lower the chance that the cancer comes back. Vinorelbine and vincristine are in a class of medications called vinca alkaloids. Dactinomycin is a type of antibiotic that is only used in cancer chemotherapy. Cyclophosphamide is in a class of medications called alkylating agents. Vinorelbine, vincristine, dactinomycin and cyclophosphamide are chemotherapy medications that work by slowing or stopping the growth of cancer cells in the body. This trial may have the potential to eliminate rhabdomyosarcoma for a long time or for the rest of patient's life.

Emily Greengard
Up to 50 years old
SITE00001780
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Inclusion Criteria:
Patients must be =< 50 years of age at the time of enrollment Patients with newly diagnosed RMS of any subtype, except adult-type pleomorphic, based upon institutional histopathologic classification are eligible to enroll on the study based upon stage, group, and age, as below. FOXO1 fusion status must be determined by week 4 (day 28) of therapy. RMS types included under embryonal RMS (ERMS) include those classified in the 1995 International Classification of Rhabdomyosarcoma (ICR) as ERMS (classic, spindle cell, and botryoid variants), which are reclassified in the 2020 World Health Organization (WHO) Classification as ERMS (classic, dense and botryoid variants) and spindle cell/sclerosing RMS (encompassing the historical spindle cell ERMS variant and the newly recognized sclerosing RMS variant). Classification of alveolar RMS (ARMS) in the 2020 WHO Classification is the same as in the ICR and includes classic and solid variants ERMS Stage 4, group IV, >= 10 years of age ARMS Stage 4, group IV Patients will be eligible to remain on protocol therapy based upon stage, group, and age Bone marrow metastatic disease is based on morphologic evidence of RMS based on hematoxylin and eosin (H&E) stains. In the absence of morphologic evidence of marrow involvement on H&E, patients with bone marrow involvement detected ONLY by flow cytometry, reverse transcriptase (RT)-polymerase chain reaction (PCR), fluorescence in situ hybridization (FISH), or immunohistochemistry will NOT be considered to have clinical bone marrow involvement for the purposes of this study Creatinine clearance or radioisotope glomerular filtration rate (GFR) >= 70 mL/min/1.73 m^2 or a serum creatinine based on age/gender as follows (must be performed within 7 days prior to enrollment): Age; Maximum serum creatinine (mg/dL) 1 month to < 6 months; 0.4 mg/dL (male); 0.4 mg/dL (female) 6 months to < 1 year; 0.5 mg/dL (male); 0.5 mg/dL (female) 1 to < 2 years; 0.6 mg/dL (male); 0.6 mg/dL (female) 2 to < 6 years; 0.8 mg/dL (male); 0.8 mg/dL (female) 6 to < 10 years; 1 mg/dL (male); 1 mg/dL (female) 10 to < 13 years; 1.2 mg/dL (male); 1.2 mg/dL (female) 13 to < 16 years; 1.5 mg/dL (male); 1.4 mg/dL (female) >= 16 years; 1.7 mg/dL (male); 1.4 mg/dL (female) Total bilirubin =< 1.5 x upper limit of normal (ULN) for age (must be performed within 7 days prior to enrollment) If there is evidence of biliary obstruction by tumor, then total bilirubin must be < 3 x ULN for age All patients and/or their parents or legal guardians must sign a written informed consent All institutional, Food and Drug Administration (FDA), and National Cancer Institute (NCI) requirements for human studies must be met
Exclusion Criteria:
Patients with evidence of uncontrolled infection are not eligible RMS that is considered a second malignancy and previous cancer(s) that were treated with chemotherapy and/or radiation. Surgical resection alone of previous cancer(s) is allowed Patients with central nervous system involvement of RMS as defined below: Malignant cells detected in cerebrospinal fluid Intra-parenchymal brain metastasis separate and distinct from primary tumor (i.e., direct extension from parameningeal primary tumors is allowed). Diffuse leptomeningeal disease Patients who have received any chemotherapy (excluding steroids) and/or radiation therapy for RMS prior to enrollment. Note: the following exception: Patients requiring emergency radiation therapy for RMS. These patients are eligible, provided they are consented to ARST2031 prior to administration of radiation Note: Patients who have received or are receiving chemotherapy or radiation for non-malignant conditions (e.g. autoimmune diseases) are eligible. Patients must discontinue chemotherapy for non-malignant conditions prior to starting protocol therapy Vincristine and vinorelbine are sensitive substrates of CYP450 3A4 isozyme. Patients must not have received drugs that are moderate to strong CYP3A4 inhibitors and inducers within 7 days prior to study enrollment Female patients who are pregnant since fetal toxicities and teratogenic effects have been noted for several of the study drugs. A pregnancy test is required for female patients of childbearing potential Lactating females who plan to breastfeed their infants Sexually active patients of reproductive potential who have not agreed to use an effective contraceptive method for the duration of their study participation
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A Phase 1b, Randomized, Vehicle-Controlled, Double-Blind, Pharmacokinetics, Pharmacodynamics, and Safety Study of ARQ-255 Topical Suspension in Healthy Volunteers and Subjects with Alopecia Areata

This study is being done to evaluate the safety and tolerability of twice daily application of the study drug, ARQ-255 topical suspension 3% people with alopecia areata. There are 2 study drugs in this study: ARQ-255 topical suspension 3% and vehicle (placebo). Participants will be randomized (like drawing straws) to either ARQ-255 topical suspension 3% or vehicle to be applied twice daily for 12 weeks. A vehicle is a study treatment that looks like the test drug and is made from the same base products used to make ARQ-255 topical suspension 3%, but it does not contain any active study ingredients.

Maria Hordinsky
18 years and over
This study is NOT accepting healthy volunteers
SITE00001818
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Inclusion Criteria:

• 18 to 70 years of age
• have alopecia areata
• able to apply topical study medication
Exclusion Criteria:

• alopecia totalis
• alopecia universalis
Dermatology (Skin, Hair & Nails)
alopecia areata
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A Phase 1B and randomized phase 2 trial of megestrol acetate with or without ipatasertib in recurrent or metastatic endometrioid endometrial cancer

The study is divided into two portions. In the first phase, we want to test the safety of a drug called ipatasertib, by testing different doses of the drug to see which dose is safer for people when given in combination with a fixed dose of a drug called megestrol acetate (MA). In Phase II, we are studying how safe the treatment is and how well it works. We are doing this study because we want to find out if this approach is better or worse than the usual approach for endometrial cancer.

Deanna Teoh
18 years and over
This study is NOT accepting healthy volunteers
SITE00001947
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Inclusion Criteria:

• grade 1 or 2 endometrioid endometrial cancer that has returned or has spread to other parts of the body (metastatic)
• may have received unlimited prior lines of treatment
• able to walk, care for self, and active at least 50% of the day
• able to swallow oral medications
• contact study staff for additional requirements
Exclusion Criteria:

• prior treatment with an AKT inhibitor
• women who are pregnant or breast feeding
• other medical or mental health diseases (study staff will review)
Cancer, Women's Health
Endometrial Cancer, Metastatic Endometrial Cancer, Clinics and Surgery Center (CSC)
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