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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.

432 Study Matches

MT2012-11C: Second or Greater Allogeneic Hematopoietic Stem Cell Transplant Using Reduced Intensity Conditioning (RIC)

The primary purpose of this study is to record outcomes and patient characteristics in the Masonic Cancer Center and BMT databases for patients who are undergoing an allogeneic (donor) hematopoietic stem cell transplant. The data will be analyzed for transplant “milestones” such as time to blood count recovery (engraftment) and how patients are doing at 3 months and 6 months after the transplant. Participation in this study will not alter treatment or medical care. All information for this study will be collected from medical records.

Principal Investigator: Troy Lund
Age Group: Not specified
This study is NOT accepting healthy volunteers
IRB Number: 1207M17641
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Sex: Male or Female
Age Group: Not specified
This study is NOT accepting healthy volunteers
Inclusion Criteria:

• up to 55 years old
• diagnosis of any disease for which a second or greater hematopoietic stem cell transplant (HSCT) is needed
• see link to clinicaltrials.gov for complete inclusion and exclusion criteria
Exclusion Criteria:

• women who are pregnant or breastfeeding
• active, uncontrolled infection
• HIV positive
Conditions: Blood Disorders
Keywords: Hematologic Disorders, Hemoglobinopathies, HSCT, Immunodeficiencies, Stem Cell Transplant, Clinics and Surgery Center (CSC)
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Pilot study_Jaw Muscle Metabolic and Brain-Derived Phenotypes of Chronic TMD Pain

The goal of this study is to learn more about a new way of gathering information about a person’s jaw muscle pain – taking scans of the jaw muscles while a person bites down on a special device. It is hoped that the information learned in this study will help the study team to design a bigger study on this new way of learning about jaw muscle pain, which may lead to better, more individualized treatments for jaw muscle pain for future patients.

Principal Investigator: Estephan Moana-Filho
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: STUDY00020619
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Sex: Male or Female
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
Inclusion Criteria:

• age between 18-74 years
• pain-free participants OR chronic jaw pain ( > 3 months),
• have a minimum set of teeth present
Exclusion Criteria:

• certain medical conditions (examples: heart disease, diabetes, autism, trigeminal neuralgia)
• any MRI contraindications (examples: metal implants, claustrophobia)
• left-handed only
Conditions: Dentistry
Keywords: Chronic Jaw Pain, Functional Brain Imaging, Temporomandibular Disorders, TMJ
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NRG-GY028: A PHASE IB AND RANDOMIZED PHASE II TRIAL OF MEGESTROL ACETATE WITH OR WITHOUT IPATASERTIB IN RECURRENT OR METASTATIC ENDOMETRIOID ENDOMETRIAL CANCER

This trial tests the safety, side effects, best dose, and effectiveness of the combination of ipatasertib with megestrol acetate to megestrol acetate alone in women who have endometrial cancer that has come back (recurrent) or has spread to other places in the body (metastatic). Ipatasertib may stop the growth of tumor cells and may kill them by blocking some of the enzymes needed for cell growth. Megestrol acetate lowers the amount of estrogen and also blocks the use of estrogen made by the body. This may help stop the growth of tumor cells that need estrogen to grow. The combination of ipatasertib and megestrol acetate may be more effective in treating endometrial cancer than megestrol acetate alone.

Principal Investigator: Colleen Rivard
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: MMCORC078
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Sex: Female
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
Inclusion Criteria:

• diagnosis of grade 1 or 2 recurrent or metastatic endometrioid endometrial cancer
• may have received unlimited prior lines of therapy
• walking and able to do all selfcare but unable to carry out any work activities; up and about more than 50% of waking hours
• must be able to swallow and retain oral medications and not have gastrointestinal illnesses that would preclude absorption of medications
• must agree to use adequate contraception during study therapy and for 28 days following the last dose of study therapy
• see link to clinicaltrials.gov for complete inclusion and exclusion criteria
Exclusion Criteria:

• diabetes either requiring insulin therapy or with a baseline fasting glucose > 160 mg/dL and/or high glycosylated hemoglobin A1c (HbA1c) (> 8)
• require chronic corticosteroid therapy of > 10 mg of prednisone per day or an equivalent dose of other anti-inflammatory corticosteroids or immunosuppressant agents for a chronic disease
• history of known or active inflammatory bowel disease (e.g., Crohn disease and ulcerative colitis) or active bowel inflammation (e.g., diverticulitis)
• clinically significant history of liver disease
• women who are pregnant or breast feeding
Conditions: Cancer
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OptimICE-PCR: De-Escalation of Therapy in Early-Stage TNBC Patients Who Achieve pCR After Neoadjuvant Chemotherapy With Checkpoint Inhibitor Therapy

This trial compares the effect of pembrolizumab to observation for the treatment of patients with early-stage triple-negative breast cancer who had a complete response after preoperative chemotherapy in combination with pembrolizumab. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. This trial may help researchers determine if observation will result in the same risk of cancer coming back as pembrolizumab after surgery.

Principal Investigator: Jocelin Huang
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: MMCORC077
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Sex: Male or Female
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
Inclusion Criteria:

• walking and able to do all selfcare but unable to carry out any work activities; up and about more than 50% of waking hours
• diagnosis of Triple Negative Breast Cancer (TNBC) without any remaining disease after neoadjuvant chemotherapy with pembrolizumab for at least 6 cycles
• no more than 12 weeks between surgery and starting the trial
• see link to clinicaltrails.gov for complete inclusion and exclusion criteria
Exclusion Criteria:

• stage IV (metastatic) breast cancer
• women who are pregnant or breast feeding
• history of any prior invasive breast cancer in either breast
• active liver disease
• medical conditions that require chronic systemic steroids (>10 mg prednisone daily or equivalent) or any other form of immunosuppressive medications and has required such therapy in the last two years
Conditions: Cancer
Keywords: TNBC, Triple Negative Breast Cancer
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Vibrotactile stimulation of the larynx to treat unexplained chronic cough

This is a study of adults with unexplained chronic cough between 18-80 years old. This study is trying to determine whether a noninvasive vibrotactile stimulation device can help reduce cough symptoms.

Principal Investigator: Stephanie Misono
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: STUDY00012174
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Sex: Male or Female
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
Inclusion Criteria:

• adults aged 18-80
• more than 8 weeks of non-productive cough
• chest x-ray or chest CT negative (collected as part of routine clinical care); no time limit on imaging (if available)
• clinical impression that untreated or inadequately treated gastroesophageal, pulmonary, and/or sinus or nasal issue is not the reason for the cough
• able to read and speak English
Exclusion Criteria:

• current smoker or quit less than 3 months ago
• infectious cause for cough (e.g., TB, pertussis, COVID)
• history of known or suspected aspiration pneumonia
• recent intubation/neck surgery (within 8 weeks)
• neuromuscular impairment that may affect cough/laryngeal sensation and/or function (e.g., multiple system atrophy, Parkinson, CVA)
• untreated carotid artery disease
• electronic implants (e.g., pacemaker)
• specific medications (study staff will discuss)
• anticipate use of new medications to treat the cough during the period of the study
• currently having speech therapy for cough
• BMI > 40 (for transmission of VTS through soft tissue)
• allergy to adhesives
• drug/alcohol dependency or abuse
• pregnant
• without regular access to wifi and internet
Conditions: Breathing, Lung & Sleep Health, Ear, Nose & Throat
Keywords: chronic cough, cough, larynx, vibrotactile stimulation, Clinics and Surgery Center (CSC)
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A multicenter, randomized, double-blind, parallel group, placebo-controlled study to evaluate the efficacy and safety of iptacopan (LNP023) in idiopathic immune complex mediated membranoproliferative glomerulonephritis (IC-MPGN). (APPARENT)

To evaluate the efficacy and safety of iptacopan compared to placebo in patients with idiopathic immune complex mediated membranoproliferative glomerulonephritis (IC-MPGN)

Principal Investigator: Nattawat Klomjit
Age Group: Not specified
This study is NOT accepting healthy volunteers
IRB Number: STUDY00020504
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Sex: Male or Female
Age Group: Not specified
This study is NOT accepting healthy volunteers
Inclusion Criteria:

• 12 to 60 years old
• diagnosis of idiopathic IC-MPGN as confirmed by kidney biopsy within 12 months prior to starting the study for adults and within 3 years for adolescents
• must have a vaccination against Neisseria meningitidis and Streptococcus pneumoniae infection prior to the start of study treatment
• see link to clinicaltrials.gov for complete Inclusion and Exclusion criteria
Exclusion Criteria:

• have had cell or a solid organ transplantation, including kidney transplantation
• Body mass index (BMI) >38 kg/m2
• Body weight <35 kg (77 pounds)
• additional criteria that study staff will review
Keywords: Clinics and Surgery Center (CSC), Glomerulonephritis, IC-MPGN
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COCOA (COCOA-PAD II)

Few medical treatments are available to improve walking ability in patients with PAD. This research study will help determine the effects of cocoa flavanols on walking ability in people with blockages in their leg arteries. Cocoa flavanols are a type of plant nutrient found in cocoa beans. These supplements are available over-the-counter at drugstores.

Principal Investigator: Diane Treat-Jacobson
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: SITE00001135
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Sex: Male or Female
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
Inclusion Criteria:

• Age 55 and older
• Presence of peripheral artery disease (PAD). PAD will be defined as either an ABI <= 0.90 at baseline or vascular lab evidence of PAD or angiographic evidence of PAD.
Exclusion Criteria:

• Unable to tolerate study pills
• Inability to walk or requiring a walker
Keywords: cocoa, intercede, pad, peripheral artery disease, prove
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Vasomotor symptoms of menopause and cardiovascular disease: What is the link?

Study to examine the physiological responses that occur during a hot flush in postmenopausal women

Principal Investigator: Manda Keller-Ross
Age Group: 18 years and over
This study is also accepting healthy volunteers
IRB Number: STUDY00013742
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Sex: Female
Age Group: 18 years and over
This study is also accepting healthy volunteers
Inclusion Criteria:
Participants must have completed menopause and experience either no menopausal hot flashes or experience three menopausal hot flashes a day.
Exclusion Criteria:

• Reported nicotine/tobacco use within the last six months
• Diabetic or asthmatic
• Diagnosed significant carotid stenosis
• History of significant autonomic dysfunction, heart disease, respiratory disease, or severe neurologic condition such as stroke or traumatic brain injury
• Existing metabolic or endocrine abnormalities
• Use of heart/blood pressure medications that are determined to interfere with study outcomes
• Use of oral contraceptives (or other hormonal contraceptives, including intrauterine devices or contraceptive implants) and/or hormone therapy
• Pregnant or breastfeeding
• Unwilling or unable to refrain from consuming caffeine or alcohol in the 12 hours before visit two and three.
• Unwilling or unable to refrain from vigorous exercise (at least 10 minutes in duration) in the 12 hours before visit two or three
• Unwilling or unable to fast in the eight hours before visit two or three
• Body mass index ≥ 35 kg/m2
Conditions: Blood Disorders, Brain & Nervous System, Women's Health
Keywords: autonomic nervous system, Blood pressure, hot flashes, hypertension, menopause, night sweats
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Prospective Evaluation of Chronic Pancreatitis for Epidemiologic and Translational Studies

This study will provide the most accurate and reliable estimates to date on disease progression and clinical events in evolving chronic pancreatitis. We also hope to develop from the results of this study some lab tests that will help us with early diagnosis of chronic pancreatitis and also to discover any genetic factors that may affect your chances of developing chronic pancreatitis.

Principal Investigator: Melena Bellin
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: SITE00001159
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Sex: Male or Female
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
Inclusion Criteria:

• diagnosis of chronic pancreatitis.
Exclusion Criteria:

• N/A
Conditions: Digestive & Liver Health
Keywords: Chronic Pancreatitis, Pancreatitis
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CPDPC16-04: Evaluation of a mixed meal test for Diagnosis and characterization of Type 3c diabeTes mellitus secondary to pancreatic cancer and chronic pancreatitis (DETECT)

Diabetes mellitus is a common condition which is defined by persistently high blood sugar levels. This is a frequent problem that is most commonly due to type 2 diabetes. However, it is now recognized that a small portion of the population with diabetes have an underlying problem with their pancreas, such as chronic pancreatitis or pancreatic cancer, as the cause of their diabetes. Currently, there is no test to identify the small number of patients who have diabetes caused by a primary problem with their pancreas. The goal of this study is to develop a blood test to distinguish these various causes of diabetes.

Principal Investigator: Melena Bellin
Age Group: 18 years and over
IRB Number: SITE00001191
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Sex: Male or Female
Age Group: 18 years and over
Inclusion Criteria:

• 30 to 84 years old
• diabetes diagnosed less than 3 years ago with Pancreatic Cancer or Chronic Pancreatitis or no disease of the pancreas
• OR longstanding diabetes diagnosed 3 or more years ago, with Pancreatic Cancer or Chronic Pancreatitis or no disease of the pancreas
• OR people don't have diabetes but have Pancreatic Cancer or Chronic Pancreatitis or no disease of the pancreas
• see link to clinicaltrials.gov for complete inclusion criteria
Exclusion Criteria:

• currently receiving oral steroid medications
• previous treatment for pancreatic cancer, including chemotherapy or radiation
• on treatment for any cancer
• see link to clinicaltrials.gov for complete exclusion criteria
Conditions: Cancer, Diabetes & Endocrine
Keywords: Chronic Pancreatitis, Diabetes Mellitus Type 3c, Pancreatic Cancer
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A phase 3, randomized, double-blind, study to assess efficacy and safety of ianalumab (VAY736) versus placebo in warm autoimmune hemolytic anemia (wAIHA) patients who failed at least one line of treatment (VAYHIA)

The purpose of the study is to see if ianalumab, compared to placebo, is effective and safe for treating wAIHA. A placebo looks like the study drug, ianalumab, but does not contain any active ingredient. Ianalumab belongs to a class of drugs called monoclonal antibodies. Monoclonal antibodies are molecules that can recognize and stick to a specific protein expressed on the cell surface or released free in the body. Participants will receive study drug (ianalumab or placebo) through the vein every 4 weeks (4 doses in total) during the treatment period.

Principal Investigator: Marshall Mazepa, MD
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: STUDY00018783
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Sex: Male or Female
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
Inclusion Criteria:

• people with documented primary or secondary wAIHA
• had an insufficient response to or relapsed after one or more treatments
• Hemoglobin concentration at screening between 5 g/dL and 10 g/dL and experiencing symptoms of anemia
• dose of supportive medication must be stable for at least 4 weeks
Exclusion Criteria:

• wAIHA due to disease involving bone marrow
• prior use of B-cell depleting therapy (e.g., rituximab) within 12 weeks prior to starting the study
• active viral, bacterial or other infections that require systemic treatment at time of screening, or a history of recurrent clinically significant infection
• positive for hepatitis C virus, hepatitis B surface antigen (HBsAg), or hepatitis B core antibody (HBcAb)
• contact study staff for additional criteria
Conditions: Blood Disorders
Keywords: hemolytic anemia, wAIHA, warm autoimmune hemolytic anemia
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The women with inflammatory Bowel Disease and Motherhood: A Prospective Registry

This is a prospective questionnaire study that will examine the impact of IBD and its surgical treatments on fertility in women with IBD of reproductive age (18-45). Women with IBD who are attempting to get pregnant within the next year will answer questionnaires about their general, surgical and reproductive health, conception history and sexual partner information. This will help identify risk factors predictive of fertility outcomes and early fetal loss, determine time to conception, and assess efficacy of fertility services including in vitro fertilization.

Principal Investigator: Eugenia Shmidt
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: STUDY00003958
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Sex: Female
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
Inclusion Criteria:

• age 18-45 years
• diagnosis of inflammatory bowel disease (IBD)
• not currently pregnant or trying to get pregnant
• desire to become pregnant within the next 12 months (may become pregnant while in the study)
Exclusion Criteria:

• prior pelvic surgery, including surgery of the cervix, ovary, uterus or fallopian tubes
• known female sterility
• known male infertility factors in partner
Conditions: Digestive & Liver Health, Women's Health
Keywords: Fertility, IBD, Inflammatory Bowel Disease
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Immune Checkpoint Inhibitor Toxicity (I-CHECKIT): A Prospective Observational Study

This study looks at how certain risk factors (such as age, gender, other medical conditions, and the type of immunotherapy used to treat the cancer) affect whether a patient with a malignant solid tumor will develop mild or serious side effects from the immunotherapy medications. Immunotherapy is the type of treatment that helps the body's immune system fight cancer. In the future, this information may help doctors make better decisions about cancer treatments

Principal Investigator: Puneet Cheema
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: MMCORC082
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Sex: Male or Female
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
Inclusion Criteria:

• planning to receive Immune Checkpoint Therapy (ICI) for a solid tumor cancer
• if received prior ICI-based therapy must have completed it at least 180 days before starting the study
• must be able to complete Patient-Reported Outcome (PRO) forms in English, Spanish, or French
• see link to clinicaltrials.gov for complete inclusion and exclusion criteria
Conditions: Cancer
Keywords: cancer, ICI, Immune Checkpoint Therapy, solid tumor
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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.

Principal Investigator: Colum MacKinnon
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: SITE00001163
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Sex: Male or Female
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
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
Conditions: Brain & Nervous System
Keywords: Clinics and Surgery Center (CSC), Parkinson Disease, Parkinson's Disease
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Registry Study of Childhood Cancer in Minnesota

The aim of this study is to obtain newborn blood spots (NBS) and tumor specimens for children and adolescents diagnosed with malignant neoplasms.

Principal Investigator: Erin Marcotte
Age Group: Not specified
This study is also accepting healthy volunteers
IRB Number: STUDY00018811
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Sex: Male or Female
Age Group: Not specified
This study is also accepting healthy volunteers
Inclusion Criteria:

• 0 to 21 years of age
• child diagnosed with any type of tumor or cancer
• born in a state that banks newborn blood spots
• able to understand English or Spanish
• parents or siblings may also contribute specimens
Conditions: Cancer
Keywords: blood specimen, cancer, tumor
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The Lung Cell Study (TLC)

The purpose of our research study is to increase our understanding on the human lung immune response to infection. We aim to use this knowledge to develop novel approaches on the prevention and treatment of lung infections. To accomplish this, we plan to obtain cells from the airways and blood of healthy volunteers to perform immune experiments.

Principal Investigator: Monica Campo Patino
Age Group: 18 years and over
This study is also accepting healthy volunteers
IRB Number: STUDY00016947
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Sex: Male or Female
Age Group: 18 years and over
This study is also accepting healthy volunteers
Inclusion Criteria:

• healthy volunteers without systemic or respiratory disease
• non-smokers or former smokers who quit more than 6 months ago (including marijuana)
• ages 18-50
• preferred but not required: have lived in countries in Africa, Latino America or South East Asia
• preferred but not required: history of positive tuberculosis (TB) skin or blood test
Exclusion Criteria:

• recent illness, bleeding disorders, or a history of heart, lung, or systemic disease
• weakened immune system or use of immunosuppressant medication
• use of inhaled substances in the past six months or history of heavy smoking
• allergy or prior adverse reaction to lidocaine, midazolam, or fentanyl
• pregnancy
Conditions: Immune Diseases, Infectious Diseases, Respiratory System
Keywords: blood, blood donation, blood draw, bronchoscopy, Healthy Volunteer, TB, TLC, Tuberculosis
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Ostomy Simulation for Patient Education Prior to Urologic Bowel Diversion Surgeries

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

Principal Investigator: Hamed Ahmadi
This study is NOT accepting healthy volunteers
IRB Number: STUDY00020255
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This study is NOT accepting healthy volunteers
Inclusion Criteria:

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

• prior or current ostomy
• women who are pregnant
• cognitively unable to care for own stoma
Conditions: Kidney, Prostate & Urinary
Keywords: bowel diversion urologic surgery, ileostomy, stoma
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A Randomized Phase II Study Comparing Sequential High dose Testosterone and Enzalutamide to Enzalutamide alone in Asymptomatic Men with Castration Resistant Metastatic Prostate Cancer

The goal of this current study is to test whether men with prostate cancer that is getting worse after treatment with hormone therapy and abiraterone respond better to alternating treatment with testosterone and enzalutamide vs. enzalutamide alone. We are testing to see which is better at stopping tumor growth that can be seen on a bone scan or CT scan and the effect of each regimen on lowering Prostate Specific Antigen (PSA values). Participants will be in the study for 6 to 24 months.

Principal Investigator: Emmanuel Antonarakis
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: SITE00001730
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Sex: Male
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
Inclusion Criteria:

• diagnosis of adenocarcinoma of the prostate
• spread (metastatic) to other organs or bone
• one chemotherapy treatment for hormone sensitive prostate cancer is allowed
• previous treatment required, study staff will review
• able to care for self with little help
Exclusion Criteria:

• prior chemotherapy with docetaxel or cabazitaxel for CRPC
• other severe medical conditions, study staff will review
Conditions: Cancer
Keywords: Clinics and Surgery Center (CSC), Castration Resistant Metastatic Prostate Cancer (CRPC), Prostate cancer
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A Randomized, Multicenter, Double-Masked, Vehicle-Controlled Phase 2/3 Study to Evaluate the Safety and Efficacy of NEXAGON® (Lufepirsen Ophthalmic Gel) in Subjects with Persistent Corneal Epithelial Defects (NEXPEDE-1) (NEXPEDE-1)

The clear layer at the front of the eye that covers the pupil and iris (colored part of the eye) is called the “cornea”. When the cornea is damaged, it normally heals within a few days but it may take up to 2 weeks depending on the size and depth of the defect (wound). Some corneal defects heal much slower than expected. A defect in the cornea that fails to heal within the normal time of 2 weeks despite using the best available medicines and procedures, is known as Persistent Corneal Epithelial Defect (or PCED for short). The purpose of this research study is to evaluate the safety, tolerability, and effectiveness (risks and benefits) of of NEXAGON ophthalmic gel for the treatment of PCEDs.

Principal Investigator: Joshua Hou
Age Group: Not specified
This study is NOT accepting healthy volunteers
IRB Number: SITE00002014
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Sex: Male or Female
Age Group: Not specified
This study is NOT accepting healthy volunteers
Inclusion Criteria:

• at least 2 years old
• diagnosis of Persistent Corneal Epithelial Defect (PCED) for at least 2 weeks that hasn't responded to one or more conventional non-surgical treatments
Exclusion Criteria:

• active eye infection that requires treatment
• additional eye conditions that exclude study participation (study staff will review)
Conditions: Vision & Eyes
Keywords: Cornea, Persistent Corneal Epithelial Defect, Vision Loss
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Assessments of sound perception and brain activation in response to paired sound and electrical stimulation of surface ear regions

We are investigating how paired non-invasive electrical stimulation of surface body regions and sound changes sound perception and tinnitus. Body stimulation regions include: external ear/behind the ear, shoulder, neck, forearm, hand, and upper arm. We aim to better understand the optimal conditions of this paired stimulation, which opens opportunities for applying this method to improving hearing loss or tinnitus. We are studying three groups of people: those with normal hearing, those with mild to moderate hearing loss, and those with tinnitus.

Principal Investigator: Hubert Lim
Age Group: 18 years and over
This study is also accepting healthy volunteers
IRB Number: STUDY00016992
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Sex: Male or Female
Age Group: 18 years and over
This study is also accepting healthy volunteers
Inclusion Criteria:

• normal hearing or hearing loss with or without tinnitus
• not users of Cochlear Implant or hearing aids
Conditions: Ear, Nose & Throat
Keywords: hearing loss, tinnitus, auditory plasticity, neuromodulation, transcutaneous electrical stimulation
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A Phase 3, Double-Blind, Randomized, Placebo-Controlled Study of Levosimendan in Pulmonary Hypertension Patients With Heart Failure With Preserved Left Ventricular Ejection Fraction (PH-HFpEF); LEVEL: LEVosimendan to Improve Exercise Limitation in Patients With PH-HFpEF (LEVEL)

Levosimendan has not been approved by the FDA to treat people who have PH-HFpEF or approved to be taken by mouth (orally). In this study, we will measure the amount of levosimendan in blood at various times and evaluate the change in participants 6-Minute Walk Distance.

Principal Investigator: Thenappan Thenappan
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: STUDY00020954
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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 pulmonary arterial hypertension
• on stable doses of heart medication for at least 30 days
• there are specific requirements for birth control for women and men
• see link to clinicaltrials.gov for complete inclusion & exclusion criteria
Exclusion Criteria:

• ability to walk is limited by anything other than symptoms (shortness of breath and fatigue) related to pulmonary hypertension
• other diagnosis related to heart function such as valve disease, cardiomyopathy, etc.
• current lung disease
• study staff will review additional inclusion & exclusion criteria
Conditions: Heart & Vascular, Rare Diseases
Keywords: Clinics and Surgery Center (CSC), levosimendan, PH-HFpEF, pulmonary arterial hypertension, pulmonary vascular disease
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Characterization of spleen motion and anatomy using imaging and sensors

This research is being performed to examine how the spleen moves during breathing in various body positions and breathing conditions. Physical measurements of the participant's body will be recorded (weight, height, and body dimensions) and then noninvasive recordings of the spleen and breathing patterns will be recorded. The spleen motion will be measured using standard abdominal ultrasound imaging, and breathing will be measured with accelerometers (small devices about the size of a quarter that measure the movement of the chest during breathing).

Principal Investigator: Hubert Lim
Age Group: 18 years and over
This study is also accepting healthy volunteers
IRB Number: STUDY00013252
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Sex: Male or Female
Age Group: 18 years and over
This study is also accepting healthy volunteers
Inclusion Criteria:

• at least 18 years old
Exclusion Criteria:

• individuals who have had a splenectomy
• people with breathing difficulties and/or individuals for whom short breath holds and modification of breathing patterns is difficult or uncomfortable
• unable to maintain five body positions: sitting, sitting with a 45 degree recline, laying on back (supine), laying on right side, and laying face down (prone) comfortably and independently
• unable to speak and read English
Conditions: Digestive & Liver Health
Keywords: Imaging, Spleen
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Rectus sheath block with liposomal bupivacaine versus thoracic epidural analgesia for pain control following pancreatoduodenectomy: a prospective, randomized, non-inferiority trial

In this study, we are comparing two different numbing techniques performed by anesthesiologists. Patients in the study are randomly selected to receive one or the other type of numbing injection. One group of patients will receive an epidural, which is a numbing injection done in the back, similar to that which women receive when they give birth. The other group of patients will receive a rectus sheath block, which is a numbing injection done on the abdomen. Both of these types of numbing injections are performed regularly by our anesthesiologists at the University.

Principal Investigator: James Flaherty
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: STUDY00019488
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Sex: Male or Female
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
Inclusion Criteria:

• pancreaticoduodenectomy at the University of Minnesota
Exclusion Criteria:

• chronic opioid use
• women who are pregnant
• see link to clinicaltrials.gov for complete exclusion criteria
Conditions: Cancer
Keywords: duodenal cancer, pancreatic cancer
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A seamless, Phase 1b/2 multiple ascending dose/proof of concept study of XTMAB-16 in patients with pulmonary sarcoidosis with or without extrapulmonary manifestations

XTMAB-16 is a new, experimental drug and is part of a group of drugs known as tumor necrosis factor alpha (TNF α) inhibitors. TNF is a protein in your body that causes inflammation. TNF α inhibitors work by suppressing part of the immune response along with reducing inflammation. We are conducting this research study to see if XTMAB-16 will help in the treatment of pulmonary sarcoidosis.

Principal Investigator: David Perlman
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: STUDY00020802
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Sex: Male or Female
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
Inclusion Criteria:

• Diagnosis of pulmonary sarcoidosis with some respiratory symptoms
• Must be taking 7.5 to 25 mg of prednisone daily and will to taper down dose
• Must be on an additional medication for the treatment of sarcoidosis
• Please contact umnsarc@umn.edu if you have any questions
Exclusion Criteria:

• Pregnancy or breast-feeding
Conditions: Breathing, Lung & Sleep Health, Rare Diseases, Rare Diseases, Respiratory System
Keywords: Clinics and Surgery Center (CSC), Sarcoidosis
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A randomized double-blind, placebo-controlled, multicenter trial assessing the impact of lipoprotein(a) lowering with pelacarsen (TQJ230) on the progression of calcific aortic valve stenosis [Lp(a)FRONTIERS CAVS]

The purpose of the study is to assess if the study treatment, pelacarsen, taken by people with mild or moderate CAVS and elevated lipoprotein(a) can safely help slow the progression of calcific aortic valve stenosis (CAVS). Pelacarsen is a treatment being tested that acts on a particle called Lp(a), which if elevated, may play a role in CAVS.

Principal Investigator: Daniel Duprez
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: STUDY00022219
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Sex: Male or Female
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
Inclusion Criteria:

• men and women between the ages of 50 and 79
• diagnosis of mild or moderate calcific aortic valve stenosis
Exclusion Criteria:

• ejection fraction (EF) less than 55%
• severe aortic or mitral valve stenosis
• uncontrolled hypertension
• history of cancer
• women who are pregnant or breast feeding
• unable to have an echocardiogram or CT scan
Conditions: Heart & Vascular
Keywords: Clinics and Surgery Center (CSC), elevated LPa, Aortic Stenosis
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AOST2031: A Phase 3 Randomized Controlled Trial Comparing Open vs Thoracoscopic Management of Pulmonary Metastases in Patients With Osteosarcoma

This phase III trial compares the effect of open thoracic surgery (thoracotomy) to thoracoscopic surgery (video-assisted thoracoscopic surgery or VATS) in treating patients with osteosarcoma that has spread to the lung (pulmonary metastases). Open thoracic surgery is a type of surgery done through a single larger incision (like a large cut) that goes between the ribs, opens up the chest, and removes the cancer. Thoracoscopy is a type of chest surgery where the doctor makes several small incisions and uses a small camera to help with removing the cancer. This trial is being done evaluate the two different surgery methods for patients with osteosarcoma that has spread to the lung to find out which is better.

Principal Investigator: Robin Williams
Age Group: Not specified
This study is NOT accepting healthy volunteers
IRB Number: SITE00001674
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Sex: Male or Female
Age Group: Not specified
This study is NOT accepting healthy volunteers
Inclusion Criteria:

• 50 years of age or younger
• have 4 or less nodules in the lung due to metastases or suspected metastases
• diagnosis of osteosarcoma
• contact study team for more detailed criteria
Exclusion Criteria:

• pleural or mediastinal based metastatic lesions, or with pleural effusion
• large, or central tumors that require a lobectomy or pneumonectomy
Conditions: Cancer
Keywords: lung cancer, osteosarcoma, pulmonary metastases, thoracotomy
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MT2022-45 Primary Immune Regulatory Disorders (PIRD): Longitudinal Study of Clinical Presentation, Treatment and Outcomes

Primary Immune Regulatory Disorders (PIRD disorders) are a group of diseases that cause the immune system to function abnormally and cause infections, autoimmunity or inflammation that can begin early in life. PIRD is usually caused by changes in genes in DNA. Researchers are trying to learn what types of medical problems patients with PIRD have and how these respond to treatment. Researchers also want to learn which genes cause PIRD and how it can cause the medical problems of PIRD.

Principal Investigator: Christen Ebens
Age Group: Not specified
This study is NOT accepting healthy volunteers
IRB Number: SITE00001766
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Sex: Male or Female
Age Group: Not specified
This study is NOT accepting healthy volunteers
Inclusion Criteria:

• age 0 to 99 years
• diagnosis of immune-mediated bowel disease affecting at least one segment of the bowel
• evidence of interstitial lung disease (ground-glass opacities) or pulmonary nodules/cysts
• decreased lung function
• additional inclusion and exclusion criteria apply (study staff will review)
• also enrolling parent, sibling, or child of eligible participants
Exclusion Criteria:

• documented HIV infection
Conditions: Rare Diseases
Keywords: Clinics and Surgery Center (CSC)
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Validation of Flexible, Wearable Sensors to Detect and Monitor Tics

The goal of this study is to design wearable, comfortable sensors to measure muscle movement during tics. Small, flexible EMG sensors (the size of the head of a pin) will be embedded in a “band-aid like” plastic sticker which is placed on the side of the face. Participants will be video recorded as they complete movement tasks. The entire visit will take approximately 2 hours.

Principal Investigator: Brianna Wellen
Age Group: Not specified
This study is NOT accepting healthy volunteers
IRB Number: STUDY00022783
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Sex: Male or Female
Age Group: Not specified
This study is NOT accepting healthy volunteers
Inclusion Criteria:

• 10 to 21 years old
• must have chronic tics present for at least 1 year
• must have at least one facial tic that occurs at least approximately once every 2-5 minutes
Exclusion Criteria:

• active acute skin disorders
• previous diagnosis of psychosis or cognitive disability
• currently suicidal
Conditions: Brain & Nervous System, Children's Health, Mental Health & Addiction
Keywords: Tic disorders, Tics, Tourette Syndrome
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A multicenter, single-arm, open label trial to evaluate efficacy and safety of oral, twice daily LNP023 in adult atypical hemolytic uremic syndrome (aHUS) patients who are naive to complement inhibitor therapy (APPELHUS)

To evaluate the efficacy and safety of iptacopan at a dose of 200 mg twice a day for 52 weeks in patients with atypical hemolytic uremic syndrome (aHUS).

Principal Investigator: Nattawat Klomjit
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: STUDY00020503
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Sex: Male or Female
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
Inclusion Criteria:

• at least 18 years old
• evidence of active Thrombotic Microangiopathy (TMA)
Exclusion Criteria:

• previous or ongoing treatment with complement inhibitors, including anti-C5 antibody
• ADAMTS13 deficiency
• positive test for Shiga toxin * direct Coombs test
• had a bone marrow transplant or hematopoietic stem cell transplant, or a heart, lung, small bowel, pancreas or live transplant
Conditions: Blood Disorders, Kidney, Prostate & Urinary, Rare Diseases
Keywords: Clinics and Surgery Center (CSC)
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MT2022-44 Analysis of Autoinflammation in Chronic Granulomatous Disease Patients Undergoing Hematopoietic Cell Transplantation or Gene Therapy (PIDTC 6908)

CGD disorders are a group of diseases that cause the immune system to function abnormally, leading to infections, autoimmunity and/or inflammation that can begin early in life. CGD is usually caused by changes in certain genes in DNA. Researchers are trying to learn what types of medical problems patients with CGD have and how these respond to treatment, including bone marrow transplantation and gene therapy. Researchers also want to learn which genes cause CGD and how specific gene abnormalities lead to medical problems.

Principal Investigator: Christen Ebens
Age Group: Not specified
This study is NOT accepting healthy volunteers
IRB Number: SITE00001764
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Sex: Male or Female
Age Group: Not specified
This study is NOT accepting healthy volunteers
Inclusion Criteria:

• confirmed diagnosis of Chronic Granulomatous Disease (CGD)
• to be scheduled to undergo HCT or GT within one year of enrollment
• additional inclusion criteria (study staff will review)
Exclusion Criteria:

• .presence of other primary immunodeficiency syndromes that do not meet the clinical and laboratory criteria for CGD
• HIV infection
• past or current medical problems or findings from physical examination or laboratory testing that are not listed above which, in the opinion of the investigator, may pose additional risks from participation
Conditions: Cancer, Rare Diseases
Keywords: Clinics and Surgery Center (CSC), CGD, Chronic Granulomatous Disease, Gene Therapy, GT, HCT, Hematopoietic Cell Transplant
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