CP is a progressive fibro-inflammatory disease where EPI develops due to destruction of pancreatic parenchyma or pancreatic duct distortion. EPI results in maldigestion, leading to fat-soluble vitamin deficiencies, weight loss, malnutrition, and impaired quality of life (Qol). Signs and symptoms of EPI include abdominal bloating and cramping, diarrhea, foul-smelling, greasy stools (steatorrhea), and unintentional weight loss. Pancreatic enzyme replacement therapy (PERT) is the mainstay of treatment of EPI. Treatment is aimed at reduction of maldigestion-related symptoms, and prevention of malnutrition and its related morbidity and mortality. CREON® is a PERT that has been FDA approved since 2009 for the treatment of EPI due to cystic fibrosis, CP, pancreatectomy, or other conditions

Beiqing Wu - wu000948@umn.edu

The purpose of the study is to test new biomarkers of amyotrophic lateral sclerosis (ALS) and primary lateral sclerosis (PLS) using MRI scans at 3 tesla (3T). Identifying biomarkers of a disease can lead to a better understanding of the disease as well as improved treatments.

Valerie Ferment - ferm0016@umn.edu

The purpose of this pilot research study is to test whether a tool called “High-Resolution Manometry” can diagnose laryngeal dystonia (also known as spasmodic dysphonia) and measure how well treatment works. High-Resolution Manometry measures pressures from a small catheter that is passed from your nose into your throat. We believe that pressures in the throat might be different for people with laryngeal dystonia than for people without laryngeal dystonia, or with other types of voice disorders. If we can diagnose laryngeal dystonia shortly after symptoms start, we can get patients the treatment they need sooner.

MN Voice Lab Study - mnvoicelab@umn.edu

The purpose of this study is to critically assess the current treatment that patients are undergoing by reviewing routine data collected and adding one additional outcome questionnaire solely for research purposes

Lydia Golden - golde406@umn.edu

This is pilot study designed to test the hypothesis that maternal probiotic supplementation is associated with infant gut microbiome variation and improved neurodevelopmental outcomes as measured by ERP performance. The primary aim is to determine if maternal probiotic supplementation during pregnancy and lactation is associated with improved recognition memory performance in infants of diabetic mothers (IDMs). This will involve recruitment and enrollment of pregnant mothers who have been diagnosed with gestational diabetes and randomization to an intervention or control group. Women in the intervention group will receive a standardized probiotic supplement during the third trimester of pregnancy through the first month of lactation. We will compare the IDMs who are exposed to probiotics via maternal supplementation or not with respect to auditory and visual ERPs at 1 and 6 months of age to determine if probiotic supplementation is associated with improved hippocampus function in infancy. The secondary aim is to examine whether maternal probiotic supplementation during pregnancy and lactation is associated with differences in maternal milk and infant fecal microbiome signatures as well as maternal milk and infant serum inflammatory protein levels. Microbial analysis will be performed on infant stool and maternal breast milk samples at one and six months of age. Infant serum and maternal breast milk inflammatory protein levels will be measured at one and six months postpartum.

Lydia Golden - golde406@umn.edu

We are doing the RARE study to learn more about Cystic Fibrosis (CF). CF is caused by mutations in a gene that produces a protein called the cystic fibrosis transmembrane conductance regulator (CFTR). In people with CF, the CFTR does not function correctly. Medications are being developed to help the CFTR function better, but those medications mostly benefit people with common CFTR mutations. There are more than 1,900 mutations of the CF gene. Some of these mutations are rare and found only in a few people. The goal of this research study is to collect specimens (blood, nasal cells, rectal cells) from people with rare CFTR mutations. Another purpose of this study is to create induced pluripotent stem cells or iPS cells. “Pluripotent” stem cells are cells that can be changed into almost any cell type of the body (such as lung or intestine). They can be kept alive and stored indefinitely. There are different kinds of pluripotent stem cells. Inducted pluripotent stem cells can be created from many different kinds of specimens (such as blood, nasal cells, rectal cells). This is different from embryonic stem cells, which can only be derived from embryos. The specimens collected during this study and iPS cells created from them will be stored for use in future research to learn more about CF and study the effect of new medications. This could identify new medications that may help people with rare CFTR mutations.

Dena Johnson - joh20459@umn.edu

The goal of the proposed project is to investigate whether brain abnormalities are present in children to young adults after the recovery from coronavirus disease 2019 (COVID-19).

Monica Bondy - bondy023@umn.edu

To collect additional real-world safety and effectiveness data for the OCS™ Lung System and to expand the long-term clinical evidence supporting the use of OCS™Lung System in lung transplantation.

Henry Madden - madde123@umn.edu

This study proposes a cross-sectional case-control pilot study. Spinal Cord Injury (SCI) is associated with altered bone metabolism, male infertility, and increased rates of insulin resistance. The researchers will perform testing for 30 men with SCI and 10 without SCI. Data will be used to power subsequent clinical trials. A Fairview letter of support has also been uploaded.

Leslie Morse - morsel@umn.edu

A single-center, single-arm, non-interventional natural history study to evaluate the longitudinal clinical course, functional outcome measures, and candidate biomarkers for individuals with DNA repair disorders, including Cockayne syndrome (CS), xeroderma pigmentosum (XP), and trichothiodystrophy (TTD).

Erin Aguero - aguer008@umn.edu

In the first phase of the study, participants will be asked to complete two sets of appointments six months apart. During both sets of appointments, participants will be asked to complete interviews and questionnaires about their life experiences and mental health, and they will have an EEG and fMRI while completing computerized tasks. The second phase of the study is optional. In this phase, participants will test one of two forms of computerized cognitive training, or brain games. They will be asked to complete 10 hours of training over a 3-6 week period. After the training period is over, they will have two sets of follow up visits, one right after the training period and one five months later. At these appointments, participants will complete the same activities done in the first phase of this study, including the interviews, questionnaires, and imaging (fMRI and EEG) combined with computerized tasks. We are recruiting two groups of participants for this study. One group will include individuals who experience hallucinations, delusions, paranoia, or a psychosis disorder (i.e., schizophrenia), and the other group will be individuals who do not have a diagnosis or family history of schizophrenia, bipolar disorder, or autism spectrum disorder.

STEP Study - stepstudy@umn.edu

We are trying to learn more about how the brain controls movement and how this affects function after stroke. We expect differences in the side of brain damage to result in distinct movements of each arm. We will collect information with standard clinical exams and movements during tasks completed on the Kinereach virtual reality system. We will compare results between people who have and have not had a stroke.

Shanie Jayasinghe - jayas045@umn.edu

The purpose of this study is to measure levels of blood and brain chemicals related to oxidative stress and inflammation in healthy volunteers and individuals with Type 1 Gaucher disease (GD1) to see if these levels are altered by GD1. We will also examine if there is a change in these blood and brain chemicals after participants begin taking oral N-acetylcysteine (NAC), which is available both as a prescription medication and a natural product that has antioxidant and anti-inflammatory effects.

Reena Kartha - rvkartha@umn.edu

The researchers aim to prove that Qigong practice can result in reduced or relieved neuropathic pain, improved mood, life satisfaction, self-efficacy, enjoyment to move, and community integration; and decreased fear of movement, use of medication or health care services for adults with spinal cord injury.

Ann Van de Winckel - avandewi@umn.edu

Freezing of gait is a common problem in people with Parkinson's disease. Episodes of freezing can be overcome when a sensory cue is provided. This study will further develop and study the efficacy of a wireless shoe insole that can monitor walking and provide a cue (acoustic or vibrotactile) when a freezing event is detected. The experiment is designed to further test the ability of the device and algorithm to reliably detect freezing and release the episode with an external cue. This study has the potential to develop a tool that can help reduce the incidence and severity of freezing events in people with Parkinson's disease.

Joshua De Kam - jadekam@umn.edu

The specific aims of the trial are to prospectively study nonischemic cardiomyopathy patients qualified for CRT-D following currently approved standard indications in order to: 1) Validate the MADIT-CRT-derived model predicting fast VT/VF in nonischemic cardiomyopathy patients with QRS≥120 ms. 2) Determine whether CMR added to the risk model validated in specific aim 1 will further improve risk stratification for predicting fast VT/VF in nonischemic cardiomyopathy patients with QRS≥120ms. 3) Evaluate costs of risk stratification using Holter and CMR in relationship to costs of implanted devices without risk stratification.

Julie Dicken - dicke022@umn.edu

There are two primary objectives of this clinical investigation. The first objective is to finalize development of the algorithm estimating CO by collecting paired cMRI measurements of CO, as well as other parameters of heart function, and CardioMEMS HF System readings in the same subject. The second objective of this clinical investigation is to use data collected during the validation phase, distinct from the subjects within the development phase, to evaluate the agreement between the CardioMEMS HF System-derived CO and the CO values from cMRI in patients previously implanted with the commercially available CardioMEMS HF System.

Julie Dicken - dicke022@umn.edu

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.

Julie Dicken - dicke022@umn.edu

The objective of the study is to define quality of life in patients with upper airway stenosis after bypassing the stenosis with either tracheotomy or t-tube stenting. Participants complete surveys over 2 years to collect quality of life information.

Ali Stockness - nicho656@umn.edu

Prospective study investigating brain activity associated with markers of suicidal behavior (SB) in adolescents.

Alanna Esquivel - esqui051@umn.edu

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.

Ali Stockness - nicho656@umn.edu

To determine if a perioperative infusion of 0.2% ropivacaine via bilateral T3 paravertebral catheters can decrease the incidence of new onset atrial fibrillation following primary CABG and/or valve surgery and compare a number of secondary outcomes.

Candace Nelson - nelso377@umn.edu

The purpose of the study is to compare the effectiveness of resistive blanket warming to forced air warming in maintaining body temperature in patients undergoing renal transplantation. Secondary outcome variables also include: • AUC of time versus temperature curves • temperatures at set points during operative period • Blood loss volumes

Candace Nelson - nelso377@umn.edu

The objective of this study is to evaluate an improvement of scalp health after the use of an investigational off-label WaterPik and brush device aimed to massage and cleanse the scalp.

Kim T. Nguyen - nguy5459@umn.edu

This study aims to determine the role of menopause and exogenous hormone use in regulating antiretroviral disposition in the female genital tract.

Sandy Bowers - kraus012@umn.edu

Prospective study to compare safety of upper versus lower extremity injection agitated saline (bubble study) using echocardiography of the heart.

Beth Jorgenson - bjorgenson@healtheast.org

No current studies have examined in vivo glenohumeral kinematics during the overhead volleyball spike despite the high prevalence of spike-related shoulder pain. The extreme shoulder positions achieved by volleyball players during the spike motion may contribute to unique deformations that could result in structural change or pathology of the rotator cuff and long head biceps tendons. The purpose of this study is to determine the extent to which GH kinematics differ between SAB and a simulated volleyball spike at a self-selected position of ball contact.

Aaron Hellem - hell0255@umn.edu

The purpose of this investigation is to identify the potentially crucial role of anticipatory reward mechanisms maintaining bulimic behavior (i.e., binge eating and purging) in bulimia nervosa (BN).

Emma Rasmussen - rasmu960@umn.edu

This is a prospective study aimed at quantifying walking and balance in patients with parkinsonism in the clinical setting in addition to a living environment setting. To accomplish this, we will use a portable motion capture system that is widely used to study biomechanics in humans. Once quantified, we want to test the effects of deep brain stimulation (DBS) frequency in patients who already have DBS systems in place. Thus, our objectives are: 1. Demonstrate that parkinsonism patient-specific kinematics can be used to detect postural instability in the clinic using wearable IMUs. 2. Demonstrate that individualized, home-based postural response curves can detect postural instability and prospectively predict fall risk in patients with parkinsonism.

Alec Jonason - jonas074@umn.edu

This is a prospective study aimed at quantifying walking and balance in Parkinson's Disease patients in the clinical setting. To accomplish this, we will use a portable motion capture system that is widely used to study biomechanics in humans. Once quantified, we want to test the effects of deep brain stimulation (DBS) frequency in patients who already have DBS systems in place. Thus, our objectives are: 1. Develop an anonymized database of quantitative postural responses and gait of PD patients. 2. Develop software that can quantify the postural response and gait of PD participants using only standard video camera footage. 3. Test the effectiveness of bilateral high and low frequency STN-DBS on the postural responses and gait of PD patients using the portable motion capture system. 4. We will passively record thalamic LFPs from patients with Medtronic Percept DBS devices while the DBS is OFF, set to low frequency, and set to high frequency.

Alec Jonason - jonas074@umn.edu