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

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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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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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Sleep Outcomes with DBS Therapy in Parkinson's Disease and Dystonia

The objective of this study is to describe how activation of distinct pathways in and around the subthalamic nucleus (STN) and internal segment of the globus pallidus (GPi) correlate to changes in sleep outcomes in movement disorders patients after deep brain stimulation (DBS) surgery targeting these structures.

Principal Investigator: Luke Johnson
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: STUDY00018981
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Inclusion Criteria:

• at least 21 years old
• existing or planned 7T brain imaging
• surgery at UMN to implant DBS system planned as part of routine clinical care (or has already occurred, as long as the first programming session is at least 2 weeks away)
Exclusion Criteria:

• other significant neurological disorder
• history of dementia
• complications after surgery
• women who are pregnant
Conditions: Brain & Nervous System
Keywords: Clinics and Surgery Center (CSC), DBS, Parkinson's Disease, Sleep Apnea
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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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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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Phase II Multi-Institutional Study of Low-Dose (2Gy x 2) Palliative Radiotherapy in the Treatment of Symptomatic Bone metastases from Multiple Myeloma

There is no consensus on the radiation dose required to relieve the pain from bone lesions from multiple myeloma. Usually, patients receive between 10 and 12 radiation treatments to achieve pain relief. But a shorter course of radiotherapy may be more effective. This study will evaluate whether pain relief can be achieved using only 1 or 2 radiation treatments, which will be delivered to a painful bone lesion. Your study doctor will decide whether you receive 1 or 2 treatments. The total amount of radiation you will receive will be the same whether it is done in one or two treatment sessions.

Principal Investigator: Stephanie Terezakis
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: STUDY00010991
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Inclusion Criteria:

• diagnosis of multiple myeloma
• painful bone metastasis that has been confirmed by a xray
• may have had any number of prior chemotherapy/immunotherapy regimens
• at least able to walk and do all selfcare but may be unable to carry out any work activities; up and about more than 50% of waking hours
• see link to clinicaltrials.gov for additional requirements
Exclusion Criteria:

• received prior radiation therapy or prior palliative surgery to the bone lesion that is causing pain
• pathologic fracture or impending fracture at the area of the bone lesion causing pain
• women who are pregnant
• additional criteria apply (study staff will review)
Conditions: Cancer
Keywords: Bone Pain, Metastatic Malignant Neoplasm in the Bone, Multiple Myeloma, Plasma Cell Myeloma
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Effectiveness of Screening and Decolonization of S. aureus to Prevent S. aureus Surgical Site Infections in Surgery Outpatients

The purpose of this study is to determine the most effective ways to get rid of Staph aureus on body surfaces before surgery. We will determine if the participants can effectively get rid of the bacteria with the simple application of various treatment methods assigned to them. We will study if these methods are useful and cost effective in preventing the infections after surgery.

Principal Investigator: Susan Kline, MD
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: STUDY00019575
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Inclusion Criteria:

• at least 18 years old
• people who are scheduled for orthopedic, urology, neuro, otolaryngology, plastic and general surgery or OB/GYN surgery
• surgery is scheduled for at least 10 days following entry into the study
• have not taken antibiotics in the week before surgery
• will have a skin incision
Exclusion Criteria:

• surgery scheduled less than 10 days after the baseline cultures
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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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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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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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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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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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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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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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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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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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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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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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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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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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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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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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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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FOLFOX in Combination With Binimetinib as 2nd Line Therapy for Patients With Advanced Biliary Tract Cancers With MAPK Pathway Alterations: A ComboMATCH Treatment Trial

This ComboMATCH treatment trial compares the usual treatment of modified leucovorin, fluorouracil and oxaliplatin (mFOLFOX6) chemotherapy to using binimetinib plus mFOLFOX6 chemotherapy to shrink tumors in patients with biliary tract cancers that have spread to other places in the body (advanced) and had progression of cancer after previous treatments (2nd line setting).

Principal Investigator: Peter Friedell
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: MMCORC081
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Inclusion Criteria:

• must have enrolled onto clinical trial EAY191 and have been given a treatment assignment to ComboMATCH to EAY191-A6 based on the presence of specific mutation as defined in EAY191
• disease has progressed on gemcitabine based first-line regimen
• adequate contraception is required
• walking and able to do all selfcare but unable to carry out any work activities; up and about more than 50% of waking hours
• see link to clinicaltrials.gov for complete Inclusion and Exclusion criteria
Exclusion Criteria:

• women who are pregnant or breast feeding
• inability to swallow oral medications or impaired gastrointestinal absorption due to gastrectomy or active inflammatory bowel disease
Conditions: Cancer
Keywords: Biliary Cancer, Gall Bladder cancer
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RCT01437: Proactive infliximab optimization using a pharmacokinetic dashboard versus standard of care in patients with inflammatory bowel disease: The OPTIMIZE Trial

The purpose of this study is to find out if using a computer program (called iDose) to guide infliximab dosing is more effective and safer than using standard infliximab dosing over 52 weeks. All patients in this study will be receiving infliximab as part of their medical care, this study is only looking at two different methods of determining the dose and timing of administration.

Principal Investigator: Byron Vaughn
Age Group: Not specified
This study is NOT accepting healthy volunteers
IRB Number: STUDY00013632
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Inclusion Criteria:

• 16 to 80 years of age
• diagnosis of moderate to severe Crohn's disease (CD) or Ulcerative colitis
• physician intends to prescribe infliximab for treatment
• have not previously taken infliximab
Exclusion Criteria:

• pregnant or breastfeeding
• complications of inflammatory bowel disease (IBD) such as abscess, need for ostomy (study staff review)
• current infection in last 6 months
• other significant medical conditions (heart, lungs, liver, endocrine etc.)
Conditions: Digestive & Liver Health
Keywords: Clinics and Surgery Center (CSC), Crohn's disease
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Testing the feasibility of a clinic-based assessment of exercise-induced maximum heart rate and heart rate recovery in adults without cardiovascular disease

We want to explore whether it is possible for adults without symptoms of heart disease to perform a short, high intensity exercise routine in a clinic setting in order to measure maximum heart rate and heart rate recovery. If this method is successful, it could be used by patients and clinicians to estimate and track heart health over time.

Principal Investigator: Jeremy Van't Hof
Age Group: 18 years and over
This study is also accepting healthy volunteers
IRB Number: STUDY00022190
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Inclusion Criteria:

• able to perform short-term intense exercise
Exclusion Criteria:

• history of heart disease such as heart failure, valve disease, arrhythmia etc.
• resting symptoms of shortness of breath or chest discomfort
• resting heart rate of 100 or greater
• high blood pressure
• women who are pregnant
• unable to speak and understand English
Conditions: Community Health, Heart & Vascular
Keywords: Exercise, Heart Health, Stress test
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REACT-AF: The Rhythm Evaluation for AntiCoagulaTion with Continuous Monitoring of Atrial Fibrillation (REACT-AF)

This research is being done to assess whether it is safe and effective to stop oral anticoagulation medications (a blood-thinning medication) during prolonged periods of normal heart rhythm in participants with infrequent episodes of atrial fibrillation (AF).

Principal Investigator: Lin Yee Chen
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: SITE00002070
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Inclusion Criteria:

• history of symptomatic or asymptomatic paroxysmal or persistent atrial fibrillation (AF) and a moderate risk of stroke
Exclusion Criteria:

• documented prior stroke (ischemic or hemorrhagic) or transient ischemic attack (TIA)
• reversible causes of AF (e.g., cardiac surgery, pulmonary embolism, untreated hyperthyroidism).
Conditions: Heart & Vascular
Keywords: AF, Clinics and Surgery Center (CSC), Stroke, AFSW, REACT
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Cardiac Sarcoidosis Consortium

This is a registry study. The Cardiac Sarcoidosis Consortium (CSC) is an international, multicenter partnership among physicians and allied professionals at major medical centers with the unifying purpose to learn more about cardiac sarcoidosis through collaborative research.

Principal Investigator: Henri Roukoz
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: 1209M20465
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Inclusion Criteria:

• People who have been diagnosed with Cardiac sarcoidosis (CS)
• History of ventricular tachycardia or fibrillation
• Ventricular arrhythmias treated medically or with an implanted device
Conditions: Heart & Vascular
Keywords: Ventricular Tachycardia, Cardiac sarcoidosis, ablation, cardiac ablation, Clinics and Surgery Center (CSC)
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A Phase 3 Randomized, Placebo-controlled, Double-blind Study to Evaluate the Efficacy and Safety of BBP-418 (ribitol) in Patients with Limb Girdle Muscular Dystrophy 21 (LGMD21) (Fortify)

This study will use BBP-418 study drug in patients with LGMD to assess the clinical biomarkers, efficacy and safety of BBP-418 during the 36 months treatment phase.

Principal Investigator: Peter Kang
Age Group: Not specified
This study is NOT accepting healthy volunteers
IRB Number: STUDY00018570
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Inclusion Criteria:

• 12 to 60 years of age
• genetically confirmed diagnosis of limb girdle muscular dystrophy
• have clinical symptoms of weakness
• weight at least 30 kg (66 lbs.)
• willing to use a highly effective method of birth control until 12 weeks after last dose of study medication
Exclusion Criteria:

• any significant medical or mental health diagnosis including abnormal lab values (study staff will review)
• surgery for scoliosis or other indication planned during the time of the study
• use of ribose or other sugar alcohol-containing supplement within 90 days of staring the study
• use of a systemic corticosteroid for the treatment of muscular dystrophy within 90 days of starting the study
Conditions: Rare Diseases
Keywords: Clinics and Surgery Center (CSC), Limb-Girdle Muscular Dystrophy Type 2I (LGMD2I), Muscular Dystrophy
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Amblyopia Treatment Study (ATS23): A Randomized Trial of Dichoptic Treatment for Amblyopia in Children 4 to 7 Years of Age (ATS23)

Amblyopia (sometimes called 'lazy eye') is reduced vision in one eye caused by abnormal visual development early in life. The weaker (or 'lazy') eye often wanders inward and outward. Amblyopia is the leading cause of reduced vision in children and can lead to blindness if not treated. Treatments for amblyopia are glasses, and if needed, further treatment with part-time patching or penalization with atropine eye drops. Patching or atropine are administered to the stronger eye to force the child to use the weaker (amblyopic) eye. In recent years, an alternative type of therapy has emerged. It is called dichoptic treatment and involves stimulating both eyes simultaneously but with different stimuli. When it was first introduced, it was done in an office-based setting. Home-based technologies utilizing games and movies have been developed and studied to a limited extent in younger children with amblyopia. In this study, we will use a system called Luminopia. It uses a virtual reality headset to view web-based videos in which the contrast of the image seen by the stronger eye is reduced by 15% from that of the weaker eye. Luminopia has been available for use in the U.S. since 2022 and has been approved by the FDA for the treatment of amblyopia in this age group. In a previous large randomized trial, home-based dichoptic movies were shown to be superior to glasses alone but treatment effectiveness compared to patching (the gold standard for treating amblyopia) has not yet been established. If dichoptic therapy using the Luminopia system is confirmed to be at least as effective as patching, it would be an appealing alternative for treating amblyopia in young children, as it shows promise of better adherence and an easier treatment experience for the parent and the child. Children in this study would be randomized 1:1 to either the Patching Group or the Luminopia Group and followed for at least 6 months. Children in the Patching Group will have the option to do the Luminopia treatment after 6 months of patching. They will be followed for an additional 6 months. Thus, their participation will last for a total of 1 year.

Principal Investigator: Raymond Areaux
Age Group: Up to 18 years old
IRB Number: STUDY00022243
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Inclusion Criteria:

• children 4 to 7 years old
• amblyopia (lazy eye) associated with strabismus, anisometropia, or both (previously treated or untreated)
• parent has phone (or access to phone) and is willing to be contacted
Exclusion Criteria:

• prism lenses or need of a prism prescription
• currently wearing bifocals
• known skin reactions to patch or bandage adhesives
• history of light-induced seizures
Conditions: Children's Health, Vision & Eyes
Keywords: Amblyopia, Lazy Eye
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Atherosclerosis Risk in Communities (ARIC) Study - Visits Component (Le-Na)

The purpose of the Atherosclerosis Risk in Communities (ARIC) Study - ARIC Generation 2 research study is to evaluate the link between glucose and heart problems in adults with type 2 diabetes. Heart problems can be common in people with type 2 diabetes. We are interested in measuring your blood sugar (glucose) using a continuous glucose monitor and monitoring your heart rhythm at the same time.

Principal Investigator: Pamela Lutsey
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: SITE00001721
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Inclusion Criteria:

• Have a diagnosis of Type II Diabetes
• Age 50-80 years old
• Be willing to wear a continuous glucose monitor and heart rhythm monitor for two weeks
• Fluent English speaker
Exclusion Criteria:

• Pacemaker
• Allergy to adhesive tape
• Planning to move away from the Minneapolis area in the next four years
• Live in nursing home/long-term care facility
• diagnosed with dementia or unable to consent for self
Conditions: Diabetes & Endocrine, Heart & Vascular
Keywords: aging, cognition, heart disease, Type 2 Diabetes, ARIC

A US Multi-center, Prospective, Non-interventional, Long-term, Effectiveness and Safety Study of Patients Treated with SKYTROFA (lonapegsomatropin) (SkybriGHt) (SkybriGHt)

Skytrofa is approved in the U.S. for sale and use in children with growth hormone deficiency (GHD). This study is being done to find out how safe and useful Skytrofa is for long-term treatment. A child’s care will follow the normal treatment practices at the clinic. There is no new treatment or medicine involved and no additional visits will be performed.

Principal Investigator: Brad Miller, MD, PhD
Age Group: Up to 18 years old
This study is NOT accepting healthy volunteers
IRB Number: SITE00002031
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Inclusion Criteria:

• 1 to 18 years old
• on treatment with SKYTROFA (lonapegsomatropin)
Exclusion Criteria:

• participating in any interventional clinical study
Conditions: Rare Diseases
Keywords: growth hormone, growth hormone deficiency
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Genetics of Developmental Disorders - Data and Specimen Repository (Le-Na)

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.

Principal Investigator: Williams Dobyns
Age Group: Not specified
This study is NOT accepting healthy volunteers
IRB Number: 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
Conditions: Brain & Nervous System, Rare Diseases, Children's Health
Keywords: Genetic disorders, developmental brain disorders, developmental disorders
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Imaging Core Aim 2, and Udall Project 2 Aim 2

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

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

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

• women who are pregnant
• extreme claustrophobia
• unable to have a MRI
Conditions: Brain & Nervous System
Keywords: DBS
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A Phase II, Multi-center, Open-Label Study to Assess Safety, Tolerability, Efficacy and Pharmacokinetics of R3R01 in Alport Syndrome Patients with Uncontrolled Proteinuria on ACE/ARB Inhibition and in Patients with Primary Steroid-Resistant Focal Segmental Glomerulosclerosis

The main purpose of this study is to check how safe the study drug is and how well your body handles taking it. We will also check if the study drug works to improve your kidney function, if has an impact on your daily life and the amount of the study drug in your blood over a period of time (called pharmacokinetics)

Principal Investigator: Michelle Rheault
Age Group: Not specified
This study is NOT accepting healthy volunteers
IRB Number: STUDY00015869
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Inclusion Criteria:

• at least 12 years of age
• for people with Alport Syndrome: confirmed diagnosis by genetic testing and /or kidney biopsy
• for primary Focal Segmental Glomerulosclerosis (FSGS), (without any identifiable cause, and where the FSGS is confirmed by renal biopsy) or FSGS where there is documentation of a genetic mutation in a podocyte protein
• female patients, as well as, female partners of male patients who are of child-bearing potential must be willing to not become pregnant for the complete duration of the study (90 days after the last dose of study medication)
• males (including sterilized subjects) whose female partners have child-bearing potential, must agree to use male contraception (condoms) during the period from the time of signing the informed consent form (ICF) through 90 days after the last dose of study drug
• contact study staff for additional criteria
Exclusion Criteria:

• uncontrolled diabetes mellitus as evidenced by an HbA1c greater or equal to 11%
• uncontrolled high blood pressure
• moderate or severe liver impairment
• BMI greater than 40
• women who are pregnant or breast feeding
• additional exclusion criteria apply (study staff will review)
Conditions: Kidney, Prostate & Urinary
Keywords: Clinics and Surgery Center (CSC), Alport Syndrome, Focal Segmental Glomerulosclerosis
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CureGN: Cure Glomerulonephropathy Network Version 2.0

The purpose of CureGN2 is to gather a group of people with glomerular disease to create a source of information and blood and urine samples, so that researchers can easily and effectively study glomerular disease.

Principal Investigator: Michelle Rheault
Age Group: Not specified
This study is NOT accepting healthy volunteers
IRB Number: SITE00000840
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Inclusion Criteria:

• Diagnosis of Glomerular Disease including MCD (minimal change disease), FSGS (focal segmental glomerulosclerosis), MN (membranous nephropathy), or IgAN (immunoglobulin A nephropathy) on first diagnostic kidney biopsy
• First diagnostic kidney biopsy within 5 years of study enrollment
• Access to first kidney biopsy report and/or slides
• All ages
Exclusion Criteria:

• End Stage Kidney Disease, defined as chronic dialysis or kidney transplant
• Solid organ or bone marrow transplant recipient at time of first kidney biopsy
• Diagnosis of any of the following at the time of first diagnostic kidney biopsy: diabetes mellitus (except gestational or diet controlled), diabetic glomerulosclerosis, systemic lupus erythematosus, HIV infection, active malignancy (except for non-melanoma skin cancer), active Hepatitis B or C infection, defined as positive viral load
Conditions: Kidney, Prostate & Urinary, Rare Diseases
Keywords: Kidney, Glomerular Disease, Clinics and Surgery Center (CSC)
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Physiological Monitoring of Participants with Chronic Pain Feasibility Study

We are asking people to participate in this study to help us learn more about how physiology (heart rate, sweating, temperature, etc.) of people with pain conditions changes based on perceived pain level. The goal is to use this information to help develop a new medical device designed to help better manage chronic pain, although we are only collecting information at this time, and there will be no treatment provided as part of this study. We expect that people will be in this research study for a maximum of 2 weeks.

Principal Investigator: Beth Groenke
Age Group: 18 years and over
This study is also accepting healthy volunteers
IRB Number: STUDY00019112
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Inclusion Criteria:
-18-90 years old
• diagnosed with painful peripheral neuropathy
• have experienced pain for at least 3 months
Conditions: Bone, Joint & Muscle, Dentistry
Keywords: Clinics and Surgery Center (CSC), painful peripheral neuropathy, healthy controls
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First Carpometacarpal Osteoarthritis Evaluation: Determining the Concurrent Validity and Test-Retest Reliability of the Thumb Disability Index (TDX) and Test-retest Reliability of Thumb Position Sense-Error using the Intermetacarpal Distance (IMD) Method

We are studying different questionnaires used to measure symptoms and activity limitations that are linked to thumb arthritis. We are also studying ways to measure thumb position sense in persons with thumb arthritis.

Principal Investigator: Corey McGee, PhD, MS, OTR/L, CHT
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: STUDY00006741
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Inclusion Criteria:

• at least 18 years old
• osteoarthritis of the joint where the bones of the wrist meet the hand (CMC)
Exclusion Criteria:

• received steroid injection treatment in the past 3 months
• history of CMC joint replacement
• nerve problems in the wrist or hand
• women who are pregnant
• unable to speak English
Conditions: Arthritis & Rheumatic Diseases
Keywords: Arthritis, CMC, CMC/Carpometacarpal, Osteoarthritis
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