A Study of Single IV Dose of UX701 for Patients with Wilson Disease
UX701is a medication for patients with Wilson's disease. Research is needed to learn the safety and effectiveness of single IV doses of UX701. The information we gain may aid future patients. (IRB#: IRB_00154398)
165-306: Pegvaliase in adolescents with Phenylketonuria (PKU)
The purpose of this study is to learn more about how the medication called pegvaliase works in people with PKU. This study will help us learn if pegvaliase combined with special Phe-restricted diet (also called a PKU diet) is safe and better than the special Phe-restricted diet alone for controlling blood Phe levels in adolescents. (IRB#: IRB_00155863)
A Computer Program Designed for Older Adults with Depression
The purpose of this study is to see how well older adults with depression can use a computer program designed to improve certain types of thinking skills (CCR-GD). We also want to learn whether participating in CCR-GD will improve both a persons thinking and mood. The information we gain may aid future patients. (IRB#: IRB_00103167)
A First-In-Human (FIH) Study of Inhibitory Interneurons (NRTX-1001) in Drug-Resistant Unilateral Mesial Temporal Lobe Epilepsy (MTLE)
NRTX-1001 is a study drug to help people with drug-resistant mesial temporal lobe epilepsy MTLE. We need to learn the safety and effectiveness of NRTX-1001 for it to be approved by the Federal Drug Administration (FDA) and used to help people with MTLE. The information we gain may aid future patients. (IRB#: IRB_00157503)
A Machine Learning Model as an Automatic Tool to Record Human Behavior
A machine learning model may automatically record a human's challenging behavior. Research is needed to learn the value of the model. We want to learn three specific things. 1) How well the model can track challenging behavior? 2) Can the model produce new information based on previous training? 3) How accurate and reliable the model can track challenging behavior based on the new information? The information we gain may aid future patients (IRB#: IRB_00157027)
A new drug combination study in children with Infantile-Onset Pompe Disease
The goal of this study is to see if a new drug combination can help children with Pompe Disease. The two drugs in the combination are called cipaglucosidase alfa (ATB200) and miglustat (AT2221). This study will also see how safe this drug combination is. (IRB#: IRB_00147223)
A new wearable device for promoting healthy sleeping
The sleep wellness device we are testing produces electromagnetic frequencies that may help relax the brain. It is a wearable band that rests on the back of the neck. This study is testing whether this new device promotes sleep quality for those looking to improve their sleep. We will begin with a baseline week (wearing a fitbit sleep monitor and answering questionniares and a text-message based sleep diary). After baseline, participants will be randomized to wear the device or a placebo for 28 days. In the last week, participants will wear the fitbit again for 7 days and answer questionnaires again to look at how sleep has changed over the 28 day period wearing the sleep wellness device. Only half of the people in this study will have their devices turned on in the active mode. The other half will not have the device on but not in the active mode. This decision will be made randomly and people in the study will not know if their device is on or off. Between 28 days and 3 months, all devices will be activated. Participants can wear the device as much as they would like. We will conduct one more questionniare assessment at 3 months. (IRB#: IRB_00165943)
A Program to Promote Resilience in Stroke Survivors and Care Partners
Stroke can have a large impact on a persons life as well as their family. Unfortunately, changes in mood, such as feeling down, anxious, or having difficulty enjoying things, can be a common experience for persons who have had a stroke. Similarly, changes in mood can also affect the persons partner, who provides support. We have created a program for couples who are coping with the effects of stroke. Research is needed to better understand how to design the most effective program that improves the emotional health of couples coping with stroke. (IRB#: IRB_00142681)
A Special Program of Recovery for People with Bladder Cancer
People diagnosed with bladder cancer who receive surgery often have some type of malnutrition (eating issue) that can make it harder to recover. A support program has been designed to see if it can reduce dietary problems from bladder cancer surgery. Research is needed to learn if the program improves the quality of life and reduces the risk of malnutrition. We want to know if the program is effective and improves a persons nutrition. (IRB#: IRB_00150155)
A Study for People with Epilepsy
Idiopathic generalizable epilepsy (IGE) is a common form of epilepsy. IGE impacts several million people. This disease can increase risks for other health conditions. Research is needed to better understand what people with newly or established IGE diagnoses need to help them improve their quality of life. The information we gain may aid future patients. (IRB#: IRB_00146602)
A study in children with Late-Onset Pompe testing Cipaglucosidase Alfa/Miglustat.
This study purpose is to learn if a new drug combination called cipaglucosidase alfa (ATB200) and miglustat (AT2221) can help children with Pompe disease. All children in this study will be treated with these drugs. The treatment will be given every two weeks. Cipaglucosidase alfa is given as an IV infusion. Miglustat is given as an oral pill. Treatment will last for about 52 weeks. Medical tests will be done during the study to track the health of participants. (IRB#: IRB_00160440)
A study in PKU testing JNT517-101
PKU (Phenylketonuria) is caused by a defective gene. When a person with PKU eats foods that contain protein, or eats aspartame, an artificial sweetener, a dangerous buildup of phenylalanine can occur. PTC923 is a study medication to reduce blood Phenylalanine (Phe) levels. This study will assess the safety and how effective this medication is for those of any age with a PKU diagnosis. (IRB#: IRB_00168112)
A Study of Children and Adults with Tuberous Sclerosis Complex-related Epilepsy
Ganaxolone is a study drug to help children and adults with Tuberous Sclerosis Complex-related (TSC) Epilepsy. Research is needed to learn how safe and effective the study drug is at reducing the number of seizures a child or adult has when added to the current epilepsy treatment and drug(s). (IRB#: IRB_00150885)
A study to better predict disease progression of patients diagnosed with chronic hypersensitivity pneumonitis (HP)
The purpose of this study is to learn more about how to predict disease progression of patients who have been diagnosed with chronic hypersensitivity pneumonitis (CHP), which is a form of lung disease. The study will evaluate high resolution computed tomography (HRCT) chest scans, pulmonary function tests (PFT), six-minute walk tests (6MWT) and questionnaires. The study will also explore blood samples to assess the progression of your condition and your response to therapy. The study will take 24 Months to complete and will require 5 visits to University of Utah Health. (IRB#: IRB_00154797)
A Study to Test a Device for People with Blood Clots
The purpose of this study is to learn more about the safety, performance, and clinical benefits of the JETi Hydrodynamic Thrombectomy System. This system is a device used in patients to remove blood clots within a blood vessel. The device is approved by the United States Federal Drug Administration (FDA). Participation in the study will last one year. Participation requires in-person clinic visits at the University of Utah and attending 2 follow-up visits in-person, virtually, or on a phone at the end of the study. Participants are paid $200 at full completion of participation. Participants are paid $200 at full completion of participation. (IRB#: IRB_00167854)
A Study to Test a Tool to Help People for Anticoagulant Drug-to-Drug Interactions
This study is to better understand the safety of oral anticoagulants (medicine for people taken by mouth to prevent blood clots) which may increase the risk of bleeding events if taken with other medications. Researchers at the University of Utah have developed an app called DDInteract to use on a technology device like a cell phone that allows doctors and patients to make decisions about drug reactions with oral anticoagulants and other medications. We want to see if using the app helps patients and their doctors learn and reduce the risks of taking anticoagulants with other medications. People in this study will participate in a virtual focus group (a discussion together with several people using technology such as a cell phone or computer). The information we gain will help us learn more about the effects of taking oral anticoagulants with other drugs. (IRB#: IRB_00167936)
A Study to Test Nasal Swab to Predict If a Lung Nodule is Cancerous
Percepta Nasal Swab Classifier is a genetic tool used to see if the risk of lung cancer is related to finding a lung nodule (unneeded tissue found in the lungs). The tool may be applied at a clinic visit when a person is tested for lung cancer or other medical reasons. The test is done by swabbing inside the nose with a small brush. The study wants to see if the Percepta Nasal Swab Classifier will help doctors and patients know if they are at risk for lung cancer. People in this study will be randomly treated with the Percepta Nasal Swab Classifier. If a person is in the test group, the doctor will receive and share results that may be used in addition to the medical care of a person. If a person is not in the test group, the doctor will not receive results and still provide medical care to assess the risk of lung cancer. Participation in the study is about 2.5 years. Participants will be paid $50 for completing the study visit. The test will be done at an in-person clinic visit. (IRB#: IRB_00168224)
A Study to Test Reflexes with Electrical Stimulation
The purpose of this study is to compare reflexes (a muscle reaction in the body) electrically stimulated on the leg or arm and lower back. Electrical stimulation is when a safe stick-on patch is placed above the skin to help reduce pain. We want to see how reflexes change with age, in different muscles and electrically stimulated places. We also want to learn how comfortable the electrical stimulation is on the back by comparing two other different common ways used to treat pain. The study requires a 3.5-hour visit to a University of Utah clinic. During the visit, reflexes will be tested on the leg or arm and back in electrically stimulated places. Participants will be paid $45 for participation. The information we learn will guide us to develop an electrical stimulation method to treat pain and restore movement in the arms and legs. (IRB#: IRB_00166846)
A Study to Test the iDOSE Computer Program with the IFX Drug for People with Crohns Disease
Crohns disease (CD) can cause many constant health issues such as severe stomach pain. IFX is a drug to help people with symptoms. iDOSE is a computer program that may guide doctors and patients with CD to know the right amount of IFX to take for better health. Research is needed to learn the effectiveness of using iDOSE. The information we learn may aid future patients. (IRB#: IRB_00153856)
ABX464: A Study Drug for People with Active Ulcerative Colitis
Active Ulcerative Colitis is a bowel disease that can cause severe stomach pain and other serious health issues. ABX464 is s study drug for people with this condition. Research is needed to learn the safety and effectiveness of ABX464. The information we gain may aid future patients. (IRB#: IRB_00164026)
Activities Among People with Physical Disabilities and Their Spouses or Partners Who Provide Caregiving
The quality of the relationship between a caregiver and their care receiver is crucial to the quality of life. The purpose of this study is to learn the effect of how participating in activities together can have on the relationship between someone with physical disabilities and their romantic partner who provides care. People in the study will participate in 20-30-minute interviews. (IRB#: IRB_00172651)
Adaptive Cycling for People with Paralysis
This study is to establish a live-cast adaptive spinning program for individuals 18 years and older who have paralysis living outside of Salt Lake County, Utah County, Weber Count, and Davis County. Participate in adaptive spinning twice a week for 60 minutes over 8 weeks from your home. We will loan a cycle for you to participate. (IRB#: IRB_00166092)
Age-Friendly Healthcare
Age-Friendly Healthcare provides care for geriatric (for this study, people 65 years and older) patients. The type of care considers what matters most: medication, mentation (mental activity), and mobility (movement). How patients receive care is specific to their needs. This study will help researchers learn how to design and test tools best to support patients and their caregivers (family or friends who help with patient care). People in the study will participate in interviews, surveys, and may wear a Garmin watch to track mobility. (IRB#: IRB_00175251)
Amniotic Fluid Epidural Injection for People with Low Back and Hip Pain caused by pressure on the Spinal Cord
Lumbosacral radicular pain is in the low back and hip caused by pressure on the spinal cord. The human amniotic fluid epidural injection is a new way to reduce this pain. Corticosteroid dexamethasone is the standard of care to improve symptoms. Research is needed to learn which is more effective at helping people with the condition. The information we learn will aid future patients. (IRB#: IRB_00131761)
Assess the Science of Daily Experiences and Quitting Smoking
Tobacco is related to at least 20 different cancers. Most attempts to quit smoking fail. Technology has been developed to better understand how real-time experiences related to a persons identity and emotions impact efforts to quit smoking. Research is needed to assess the support people need to stop smoking. The information we learn may aid future patients. (IRB#: IRB_00157042)
Assess the Science to Stop Smoking
Tobacco is related to at least 20 different cancers. Most attempts to quit smoking fail. Technology has been developed to better understand how a persons emotions impact people in their efforts. Research is needed to assess the support people need to stop smoking. The information we learn may aid future patients. (IRB#: IRB_00104596)
Assessing the Presentation and Symptom Burden of Postural Orthostatic Tachycardia Syndrome (POTS)
Postural Orthostatic Tachycardia Syndrome (POTS) is a blood circulation disorder. This study wants to learn more about how to help people with diagnosed POTS or suspected POTS. People in this study will complete surveys. Participation can last about 60 minutes or less. Surveys can be completed using a paper copy at home, electronically, and in person at a clinic visit. (IRB#: IRB_00137161)
Asthma & Voice Disorders
Asthma is when a person has difficulty breathing due to swelling or inflamed airways. A voice disorder is when a person may have a problem with speaking due to swelling or inflamed vocal cords. The study wants to learn the effect of taking inhaled medication (medication given to some people with asthma) on people with voice disorders. People in the study will attend visits in person at a study clinic. Medical tests and voice evaluation will be done during the study to track the health of participants. (IRB#: IRB_00088230)
Autosomal Dominant Polycystic Kidney Disease Health Information Study
Autosomal Dominant Polycystic Kidney Disease is the most common genetic cause of renal failure (kidneys unable to remove waste and fluid in the body). Autosomal Dominant Polycystic Kidney Disease has been typically known as an adult disease. However, it is becoming known as a disease that begins in childhood. Guidelines for how to help children diagnosed with or at risk for Autosomal Dominant Polycystic Kidney Disease are lacking. The study wants to learn more about Autosomal Dominant Polycystic Kidney Disease and other kidney diseases. The study also wants to expand internet resources so anyone can learn about Autosomal Dominant Polycystic Kidney Disease or other hepato/renal fibrocystic diseases that affect the kidneys. Being in this study does not require attending a visit to a study clinic. Participation does require giving permission for the study team to have access to participants' medical information. Some information that could be collected, would be clinic notes, lab results, and physician consult reports. Participants' names and addresses will be removed from all health information the study team receives. (IRB#: IRB_00142152)
Avenues for Improving Memory
This study wants to learn the processes of how a persons new movements are learned and remembered. Participants will attend 2 separate in-person visits at the University of Utah. Each visit can last 20 to 40 minutes. Participants will complete a survey and a series of finger tapping tasks on a computer while sounds are played at each visit. Participates will write in a sleep diary 3 nights before the first visit and the night between the 1st and 2nd visit . During the night between the 1st and 2nd visit participants will wear a watch on the wrist to record times of activity and rest. Participants will be paid for their time. (IRB#: IRB_00171674)
Barriers to Low Back Pain Healthcare for People who are Underserved
Low back pain can require imaging (taking a picture) and other medical needs of the lumbar, (lower part of the back). People may have issues attending appointments for their lower back pain. These include language and translation services and lack of health insurance. The study wants to learn how to better help people attend their appointments for low back pain. Being in the study requires completing a survey. The questions may ask about needing an interpreter, health insurance, childcare, or transportation. People who need health insurance or an interpreter will be given help to attend the appointment. The study team will gather data to learn how to better help participants attend doctor appointments. Information collected will not identify the persons name, address, or phone number. (IRB#: IRB_00156672)
BAX 111 rVWF in Pediatrics
The purpose of the study is to look at how well recombinant von Willebrand Factor (rVWF) (the study drug) works to control bleeding that is not caused by surgery. The study will involve children with severe von Willebrand disease (VWD), and we hope to learn how safe the study drug is and how well it is accepted. The study will also look at how safe the study drug is and how well it works during surgery. Finally, the study will look at how childrens bodies process the study drug. This is a Phase 3 study, which means the study drug has already been given to other patients in other studies. In a Phase 3 study the new drug is tested longer and on more people. (IRB#: IRB_00099444)
Biomarkers in People with Heart Failure and Open-Heart Surgery
Biomarkers are a way for doctors to track a persons health such as blood levels. This study wants to see how biomarkers change with normal heart function compared to those with heart failure. The study will measure blood levels before and after heart surgery with a bypass machine (a heart-lung machine that takes over the heart and lungs during surgery). The study has two purposes. One, help doctors learn the differences in heart failure patients response to surgery. Two, identify patients who may benefit from a different type of blood pressure medication after surgery. People in the study will complete surveys and other medical tests related to heart function before and after heart surgery. (IRB#: IRB_00173355)
Brain Changes with Chronic Pain and Chronic Pain Recovery
Chronic pain is persistent pain in the body. This study wants to learn how people with chronic pain relate to pain and how it impacts the brain. This study also wants to learn whether brain changes will be restored during chronic pain recovery. The knowledge learned will help doctors better understand how to prevent and treat chronic pain issues. People in the study will be in 3 groups. Healthy participants who have never experienced chronic pain. Participants currently experiencing chronic pain. Participants who have recovered from chronic pain. Being in the study requires about 2 visits to the study clinic. Compensation will be given for participation. Medical tests will be done to track the health of participants. (IRB#: IRB_00172536)
Brain Recordings for People with Deep Brain Stimulation for Severe Obsessive-Compulsive Disorder
Obsessive-Compulsive Disorder causes a person to have constant thoughts that can lead to repeated behaviors that may severely disrupt a persons life. This study will look at the effects of deep brain electrical stimulation therapy (small electrodes implanted in a persons brain that send mild amounts of electricity) on a patient with this disorder who has already been implanted with the Deep Brain Stimulation system. The study aims to better understand the relationship between brain activity, behavior, and Obsessive-Compulsive Disorder symptoms to help people with this disorder. People in this study will have the already recorded brain activity they received as standard of care collected and analyzed. Being in the study may last as long as the participant receives stimulation therapy and wants to participate. (IRB#: IRB_00169174)
Brain Treatment of Adults with an Eating Disorder
This study is testing a new method to help people who have excessive food intake. The method is done by using an ultrasound to stimulate the brain. This study wants to see how well the method works at helping people with the condition. People in the study will have pictures taken of the brain and an ultrasound device applied to the head. People in the study will attend 18 study visits over about 4 months (IRB#: IRB_00175583)
Breast Cancer Magnetic Resonance Imaging (MRI) Study
Breast cancer is the second most common cancer for women in America. Magnetic Resonance Imaging (MRI) can be used to see breast cancer. Research is needed to design better imaging techniques for breast cancer imaging. Information we gain may aid future patients. (IRB#: IRB_00114506)
Building Transition Readiness Skills for Adolescents and Young Adults with Congenital Heart Disease
Congenital heart disease (CHD) is one of the most common birth defects with most major effects diagnosed in infancy. Because there is no cure for CHD it is a lifelong chronic illness. Research is needed to understand the needs of people with CHD as they transition from child to adulthood. This information will improve the care and quality of life for people with CHD. (IRB#: IRB_00156291)
C4671026: Study drugs for Children with COVID-19 in Children
Nirmatrelvir and Ritonavir are study drugs for children with COVID-19. These study drugs are only approved by the federal drug administration (FDA) for adults. Research is needed to learn the effectiveness of the study drugs and find the best dose for children with COVID-19. (IRB#: IRB_00155069)
CABL001I12201: A Study Drug for Children with Philadelphia Chromosome-Positive Chronic Myeloid Leukemia
Philadelphia chromosome-positive chronic myeloid leukemia is a disease that causes abnormal changes to the chromosomes leading to high levels of abnormal cells in the bone marrow and blood. CABL001I12201 is a study drug for children with this disease. Research is needed to learn the safety and effectiveness of the study drug. The information we gain may aid future patients. (IRB#: IRB_00158588)
Cancer Stories Shaping Outcomes Can Your Cellphone Be a Compassionate Listener?
This study is looking at cancer patient voices, actions and body language using computer measurements of behavior via video-recorded answers to questions on your smartphone device using a free app. This research is important because it may help us discover and understand unknown factors that impact cancer treatment outcomes. (IRB#: IRB_00143135)
Cannabis (CBD) Effects of Treating People for Chronic Non-Cancer Pain
Cannabis (CBD) is a treatment shown to reduce non-cancer chronic pain. Research is needed to learn more about how CBD impacts brain chemistry. The information learned will help us better understand the effectiveness of CBD for improving the health of people suffering from chronic pain. (IRB#: IRB_00124865)
Caracterizar la variabilidad en el funcionamiento ejecutivo y diario en adultos hispanos y latinos mayores (Characterizing Variability in Executive and Daily Functioning in Hispanic and Latino/a/e Older Adults)
Estamos analizando las relaciones entre las habilidades de pensamiento y funcionamiento cotidiano en adultos de habla hispana quienes tienen de 50 años en adelante. Estamos observando el impacto de varios factores diarios, tal como el estado de ánimo, sueño y dolor en la habilidad de pensar y completar tareas todos los días. El estudio implicaría venir a la Universidad de Utah para una consulta de investigación de 4 horas y luego hacer tareas diarias en su casa por las siguientes 3 semanas. ¡Le pagaremos su participación! No tiene que tener número de seguro social para participar. Comuníquese con nosotros para más información si está interesado y cumple con el criterio del estudio. (We are examining the relationship between thinking skills and daily functioning in Spanish-speaking adults who are 50 and older. We are looking at the impact of many daily life factors, such as mood, sleep, and pain, on your ability to think and get tasks done each day. The study will involve coming to the University of Utah for a 4-hour research visit and then doing daily tasks at home for the following 3 weeks. We will pay you for your participation! You do not need to have a social security number to participate. Please contact us for more information if you are interested and meet the study criteria.) (IRB#: IRB_00166063)
Caregiver burden associated with Rotavirus-gastroenteritis in the United States
You and your child are being invited to participate in this observational research study. Your participation is voluntary. An observational study is research that aims to collect data over time on how a certain treatment is used and its effects, without any change to your normal care. This means that routine clinical practice is followed. Any treatment given follows your normal routine and is decided by you and your doctor. This study will not alter or interfere with the normal care you receive in any way. (IRB#: IRB_00148762)
Caregivers' Emotions to Their Young Children Related to Stress
This study is to better understand families' experiences with their young children. We want to know about the emotions that caregivers show to their children and how these are related to caregivers' stress levels. This will help us better support families and their young children. People in this study will complete surveys on an iPad or phone for 14 days for one month. Compensation is provided for the completion of surveys. Participant names are not identified. What we learn will help us better understand how caregivers stress and emotions are expressed to their children. (IRB#: IRB_00165890)
Cervical Medial Branch Radiofrequency Ablation (CMBRFA) compared to Trident Multi-tined Cannula for People with Cervical Facet Pain
Cervical facet pain is an arthritis-like joint pain that can be chronic and occur in the back and neck of the spine. Cervical medial branch radiofrequency ablation (CMBRFA) is an effective treatment for this health issue. Trident Multi-tined Cannula is also a way to help people with cervical pain. Research is needed to learn the characteristics and effectiveness of Trident Multi-tined Cannula compared to CMBRFA. The information we gain may aid future patients. (IRB#: IRB_00143800)
Children and Adults with Eosinophilic Esophagitis (EoE), Gastritis (EG) and Colitis (EC)
EoE, EG, and EC are digestive diseases. Research is needed for us to understand the relationship of EoE, EG, and EC with mucosal eosinophilia, severe stomach, and bowel pain, in children and adults. The information we learn will help us find better ways to provide care for children and adults with these diseases. (IRB#: IRB_00113124)
Chronic Non-Cancer pain MRI research study evaluating the effects of oral cannabis on chronic pain
The purpose of the study is to evaluate the effects of two substances derived from cannabis (THC and CBD) in participants with chronic non-cancer pain compared with a placebo. The study drug will be administered as an extract mixed in chocolate pudding. Participants will be allowed to stay on their current pain treatments for the study but may not add any more medications during the study. Participation in this study will be confidential. This study has been approved by the FDA, DEA, and University of Utah IRB. (IRB#: IRB_00103451)
Circadian Timing and Chronic Disease
Circadian timing is when a person's daily behaviors occur such as eating and sleeping. Circadian timing may affect a persons health and well-being. Research is needed to learn if improving circadian timing impacts body metabolism (how a person processes and uses food). Which may lead to chronic diseases such as diabetes and heart disease. The research we gain may aid future patients. (IRB#: IRB_00159535)
Comparing COVID-19 Boosters for Protection Against the SARS-CoV-2 Virus
This study is to understand better whether and how well COVID-19 booster vaccines protect people from the SARS-CoV-2 virus. The information we gain will help us learn more about how to provide people with better protection against this virus. People in this study will complete online surveys and take at-home COVID-19 tests. Two groups are in the study, and people can choose the group they want to participate. One group does not receive the COVID-19 vaccine, and the other does receive the COVID-19 vaccine. Compensation up to $550 is provided for the completion of study activities. (IRB#: IRB_00172738)
Connecting Online Peers to Support Adults with Type 1 diabetes
Diabetes is a serious disease for millions of Americans. Self-management of the condition can be difficult. Social support shows people better manage the disease by working with peers. Connecting online peers is a way to help people with the disease. Research is needed to compare the effectiveness of online peer support groups for young adults with type 1 diabetes. (IRB#: IRB_00153324)
Consumer Decision Making
This study is designed to understand the day-to-day decisions made by consumers. (IRB#: IRB_00136063)
Consumer Financial Decision Making
Consumer financial decision-making is when and how a person decides to spend money on purchases such as housing and food. This study will help to better understand when and how people make daily decisions about spending money including using credit cards. People in the study will be randomly assigned into groups. Participants may be asked to think about spending money, choosing how to make purchases, and making purchases. Participants will be asked to share and write their thoughts about consumer financial decision-making and complete surveys. (IRB#: IRB_00172376)
Continuous Glucose Monitoring in Adults with Diabetes and Cognitive Impairment or Dementia and Their Care Partners
Continuous Glucose Monitoring is a way to show people with diabetes when they have high or low blood sugar throughout the day. Continuous Glucose Monitoring data can be shared continuously with care partners (family or friends) using an app. However, the person with diabetes and their care partner may need help communicating and problem-solving using the sugar data. This study will explore how to change a current program that uses this data-sharing app. The new program will help older adults with diabetes and cognitive impairment (hard to remember or learn new things), or dementia (memory loss) and their care partners share Continuous Glucose Monitoring data. People in the study will complete a survey and attend a 30-to-90-minute discussion with about 5 to 8 other people to give researchers advice on how to change a current Continuous Glucose Monitoring program. People will be paid for participating. (IRB#: IRB_00172781)
Continuous Glucose Monitoring with Data Sharing in Older Adults with Type 1 Diabetes and Their Care Partners
The purpose of this study is to learn if a new phone app for data sharing helps older adults with type 1 diabetes and their care partners better monitor glucose levels. Research is needed to improve how people with diabetes and their care partners communicate, problem-solve, and develop action plans around data sharing glucose data. The information we gain may aid future patients. (IRB#: IRB_00160673)
Couples, healthy aging, rhythms and sleep study (CHARMS)
As people get older they are more likely to have changes to their bodys rhythms, like waking up too early or in the middle of the night. As people get older, their sleep quality also goes down. We also know that sleep in one partner can affect the sleep of the other. Research is showing that having regular sleep/wake rhythms and good quality sleep can help your memory as you get older. The goal of this study is to understand how sleep in couples affects each others sleep and memory over a 2-year period. (IRB#: IRB_00158095)
Cuffless Blood Pressure Study in Patients with Cardiovascular Conditions
This study aims to test bioimpedance technology to measure blood pressure in patients. Normally people measure their blood pressure with an inflatable cuff on their arm. Bioimpedance technology involves placing sensors in the skin for non invasive recordings. People in this study will wear this new device at the Heart Failure Clinic at the University of Utah Medical Center. These will help us get more measurements to see if the technology works. The study session will last about 30 minutes. (IRB#: IRB_00170063)
Deep Brain Therapy with Ultrasound for Treatment of Cognitive Impairment
This study is testing a safe new kind of brain stimulation as therapy for cognitive impairment (difficulty remembering, learning new things, or making everyday decisions). Recent technology has made it possible to improve the ultrasound (a way to see inside of a persons body) used to reach deep areas of a persons brain. This study wants to show that ultrasound reaches focused areas of the brain. Learn its effects on cognitive performance. As well as the overall experience of deep brain therapy with ultrasound. Being in the study requires 6 to 9 study visits at a clinic for about 1 to 2 months. This includes completing surveys, interviews, a physical exam, ultrasound, and MRI (a way to see the inside of a persons body). Medical tests will be done during the study to track the health of participants. The study wants to see if deep brain therapy with ultrasound will help people with cognitive impairment. (IRB#: IRB_00173042)
Delayed Orthostatic Hypotension in Individuals with Parkinson's Disease
A persons autonomic nervous system is the part of the nervous system that controls involuntary actions, such as the beating of your heart and the widening or narrowing of the blood vessels. Parkinson's disease can cause dysfunction of the autonomic nervous system causing orthostatic hypotension which is a form of low blood pressure that happens when you stand up from sitting or lying down. Orthostatic hypotension can make a person feel dizzy or lightheaded and may even cause fainting. Delayed orthostatic hypotension describes a drop of blood pressure happening beyond 3 minutes of standing. The purpose of this study is to learn the frequency and risk factors of delayed orthostatic hypotension in people with Parkinsons disease. The information will help clinicians be better aware of providing care to patients with delayed Orthostatic hypotension. People in the study will have their blood pressure and heart rate measured. There will be only one 20-minute study visit to measure these. (IRB#: IRB_00170338)
Developing a Database for Clinical Trials Related to Alpha-1
Alpha-1 is a genetic condition that causes damage to the lungs and/or liver. This study intends to develop a database of people interested in participating in clinical trials related to alpha-1. A clinical trial is a kind of research that tests how well new approaches in medicine work for people. The database will be used to help interested people learn about and enroll in clinical trials. There are no procedures or treatments in this study. Participants will be asked to allow a small number of their medical records to be transferred to the Sponsor, who will take the data from records and store the data in the database. People in the study will be contacted every 3 months to provide health updates. People in the study will also be contacted if they qualify for a clinical trial study. Being in the study lasts as long as the study continues at the University of Utah. (IRB#: IRB_00177865)
DNL310: A Study Drug for Children and Adolescents with Hunter Syndrome
Hunter syndrome is a disease that may cause delays in cognitive (part of the brain) development and disruptive and impaired behaviors in children and adolescents. DNL310 is a study drug for children and adolescents with Hunter Syndrome. Research is needed to learn the safety and effectiveness of DNL310. The information we gain may aid future patients. (IRB#: IRB_00157640)
DTX301-CL301: Gene Therapy for Late-onset Ornithine Transcarbamylase Deficiency (OTC deficiency)
Ornithine Tanscarbamylase Deficiency (OTC deficiency) is an inherited disorder that causes toxic levels in the blood. The disease increases the risk of mental health problems and other health issues. DTX301-CL301 is a study drug used for gene therapy. Research is needed to learn the safety and effectiveness of the treatment. The information we gain may aid future patients. (IRB#: IRB_00150121)
Dual-Tracer Theranostic Position Emission Tomography (PET)
Position Emission Tomography (PET) /CT scans are a way to see images inside of the body. Theranostics are a combination of using a radioactive drug to diagnose and a second radioactive drug to deliver therapy. Research is needed to develop methods that combine 2 different types of scans. These may be given to patients with neuroendocrine tumors and prostate cancer. The goal of the study is to eliminate the need to have the scans given separately and combine them into one patient health clinic visit. (IRB#: IRB_00158172)
Early Detection of Lung Cancer based on small RNA signatures (Boston II)
This study will see if a new test can diagnose lung cancer. The new test is called the HBDx small RNA diagnostic test for lung cancer. People in this study will participate for 12 months. You will give blood at one clinic visit at the start of the study. This blood will be used to run the new test. We will collect information from your medical record for 12 months after the visit. At the end of 12 months, we will contact you to ask about any imaging, biopsies or surgical procedures you might have had at another healthcare facility. (IRB#: IRB_00166058)
Efzofitimod: A Study Drug for People with Pulmonary Sarcoidosis
Pulmonary Sarcoidosis is a disease that most commonly affects the lungs and causes other health conditions that impact a persons quality of life. Efzofitimod is a study drug to help people with this disease. Research is needed to learn the safety and effectiveness of the drug. The information we gain may aid future patients. (IRB#: IRB_00156634)
Emotional Awareness and Expression Therapy (EAET): A Study Treatment for People Living with Migraine
Migraine headaches are a severe health problem. Though there is current medication and ways to help people with migraine, most still have issues. A persons level of stress and past traumatic experiences may cause migraine. Emotional Awareness and Expression Therapy (EAET) is a new way to help people manage emotions. We want to know how effective EAET is at reducing migraine. The information we gain may aid future patients. (IRB#: IRB_00164970)
EndoVascular Device for People with Wide-Neck Aneurysms
A wide-neck brain aneurysm is an abnormally enlarged blood vessel usually an artery, due to a defect, disease, or injury. The EndoVasucular device is to help people with the aneurysm. Research is needed to learn the safety and effectiveness of the device. The information we gain may aid future patients. (IRB#: IRB_00131046)
Environmental Influences on Child Health Outcomes
A persons environment and genetics may impact the health of families for generations. An increase has occurred in health-related events such as obesity, asthma, and autism. This study will see how a persons genes and environment impact health conditions and diseases. The study wants to better prevent and protect people from harmful health conditions. People in this study will not be asked to do anything different in their daily lives and will not be asked to take any drugs. Participants are required to take surveys and write in a diary. Participants will meet with the study team at a study clinic, on the phone, by mail, other technology, or participants homes. Participants are paid for each task completed. (IRB#: IRB_00166922)
Eosinophilic Esophagitis Dietary Effects
Eosinophilic Esophagitis is a disease that often causes allergic reactions to types of food. When patients with this disease eat certain foods, they may have trouble swallowing and get food stuck in their esophagus. Over time, scarring and narrowing of the esophagus can occur. Currently, the only way for patients to identify the types of food that trigger the disease is to eliminate foods from the diet. This requires endoscopy with biopsies every 6-8 weeks after each diet change. Research is needed to develop a better way to diagnose and improve the health of people with Eosinophilic Esophagitis disease. (IRB#: IRB_00149437)
Evaluation of Sensory Tricks in Individuals with Laryngeal Dystonia or Essential Vocal Tremor
Laryngeal dystonia (LD) is a rare neurogenic voice disorder that results in an intermittently strained-strangled or breathy voice quality during speaking. Essential tremor of the voice (ETv) is another neurogenic voice disorder typically perceived as a shaky voice quality but sometimes associated with a similar voice quality to LD, making it challenging for clinicians to distinguish these voice disorders. A correct diagnosis is essential for accurate and effective treatment of these voice disorders. However, clinical voice experts often confuse these disorders and frequently disagree with each other when judging voice quality or observing speech structures. Development of clinical tools that help clinicians make the correct diagnosis of these disorders is a priority. Therefore, we propose studying a characteristic of dystonias, sensory tricks. A sensory trick is a phenomenon diagnostic of dystonias described as a short-term improvement of symptoms due to sensory cues like touching or supporting a body part or being distracted by a sound. This phenomenon is well studied in other kinds of dystonia but has not been systematically evaluated in LD. This pilot study aims to evaluate whether sensory tricks improve voice symptoms in those with LD compared to those with ETv. If successful, outcomes will help identify specific sensory trick(s) that most clearly change LD symptoms and show promise for improving correct diagnosis of those with LD. The sensory tricks studied should be accessible and affordable for use during assessment by clinicians to help distinguish those with LD from ETv. Importantly, findings will inform future studies to improve utilization by clinicians. (IRB#: IRB_00130977)
Evaluation of the HAPPIEST program - a collaborative team summer research program
The overall goal of this project is to evaluate the training program at University of Utah of undergraduate students from underrepresented racial/ethnic backgrounds in air pollution-related health research through a faculty-mentored summer program called Health, Air Pollution and Population Initiative in Education and Science Training (HAPPIEST). Since exposure to air pollution and environmental health issues are magnified in racial/ethnic minority communities in the US, this project addresses an important need in biomedical science training for the next generation, as social disparities and the socio-behavioral sciences are becoming increasingly important to health scholarship as well as US national priorities. (IRB#: IRB_00144170)
Exercise and Brain Function
Exercise is known for helping a persons brain function. Research is needed to better understand how exercise may help improve the brain's learning and memory processes. The information we gain may aid future patients. (IRB#: IRB_00152596)
Expanding Web-Based Resources for People with Autosomal Recessive Polycystic Kidney Disease
Autosomal recessive polycystic kidney disease (ARPKD) is a rare inherited disorder. It is part of the Hepato/Renal fibrocystic disease group that affects the kidneys. The study will view past, current, and future medical information once given permission. The study wants to expand web-based resources so anyone can learn about ARPKD or other hepato/renal fibrocystic diseases. (IRB#: IRB_00124267)
Factors of Mental Health and Social Influence
This study wants to learn more about how a person's social and identity influence mental health. These include attitudes, opinions, decision-making, and finding help. Participants in this study will take a survey. The survey is about everyday life experiences and ideas about mental health. These include decision-making, seeking help, social influence, and identity. The survey will be done online with technology such as a computer or cell phone. The survey will take about 30 minutes. (IRB#: IRB_00167428)
Ferric Citrate: A Study Drug for Children and Teenagers with Hyperphosphatemia from Chronic Kidney Disease
Chronic Kidney disease can cause Hyperphosphatemia (extra phosphate in the blood). Ferric Citrate is a study drug for children and teenagers with this condition. We are trying to find out if the study drug can safely lower the amount of phosphate in the blood of children and teenagers. The information we gain may aid future patients. (IRB#: IRB_00161276)
FIREFLY-1
The description and purpose of the study drug is to research the use of an investigational product labeled NA- IP (DAY 101- formerly TAK-580/MLN2480) to treat Low-Grade Glioma and other advanced solid tumors in pediatric and age-of-majority participants (IRB#: IRB_00138633)
Genetic Testing in Rural Communities
A genetic test can help people get personalized healthcare (disease risk genetic testing). These genetic tests can also identify people who may have a child with a severe disease so that people can make family planning decisions that are in line with their values (carrier genetic testing). Some studies say there are inequalities in genetic testing between people who live in rural areas and people who live in urban areas. People from rural communities in Idaho, Montana, Nevada, Utah, and Wyoming will participate in interviews. People who participate will have considered getting disease risk or carrier genetic testing. The study wants to learn about the genetic testing experiences of people who have and have not had disease risk or carrier genetic testing. The study wants to better understand what makes it easier and harder for people in rural communities to have genetic testing. This will help identify strategies for people who live in rural areas can get the same genetic testing as people who live in urban areas. (IRB#: IRB_00176898)
GIGA-KIDS
IgA Nephropathy (IgAN) and Henoch-Schönlein Purpura (HSP) are related diseases, both thought to be due by deposits of the IgA antibody in the kidney. The purpose of this study will be to determine how some genes affect the development of IgAN and HSP. We also will look for substance sometimes found in the blood as a response to the disease (biomarkers). Normal, healthy children will also be enrolled in this study to make sure that our tests are working properly. Participation in this study will consist of having a blood draw on just one occasion and collection of information that will be entered in a registry or database where it is expect to remain active indefinitely. The data will be housed in a database managed by Nationwide Childrens Hospital. Participants may be compensated. (IRB#: IRB_00074302)
Hair Chemicals in Children with Autism Spectrum Disorder
Chemicals applied to a childs hair may impact health outcomes, especially for children with an autism spectrum disorder. Research is needed to learn how chemicals in these children's hair such as zinc, copper, and lead affect health. We also want to know if finding these chemicals in hair is a way to detect autism disorder sooner. The information we gain may aid future patients. (IRB#: IRB_00153961)
HCI-Total Cancer Care Study
This study is a partnership between participants, health care providers, and researchers. Our aim is to better understand what causes cancer and to find better ways to prevent, detect, and treat cancer more successfully while also supporting your family. This study is an opportunity to contribute samples and information that will be used to accelerate cancer research and improve patient care. Participants like you are vital to our success. The study also offers access to a broader set of clinical trials and new treatments through our partnership with other leading cancer centers nationally. There is no cost to be in this study. No matter what you decide, it won't change the relationship with your health care providers to affect the quality of your care. (IRB#: IRB_00089989)
HEALEY ALS Trial
This study is looking at the safety and effectiveness of four different investigational treatment regimens: Zilucoplan, Verdiperstat, CNM-Au8, and Pridopidine for ALS. Each regimen will have an active investigational product and a matching placebo that will be tested. New regimens will be continuously added as new investigational products become available. (IRB#: IRB_00143448)
Health and Safety Consequences of Poor Sleep Health
Sleep is a key factor affecting your overall health. We want to investigate if altering your nightly sleep duration impacts your bodys metabolism (how you metabolize food). We will also look at your physical activity, food intake, and cognition during the study. (IRB#: IRB_00133959)
Hearing Effects in Children with CMV
Cytomegalovirus (CMV) is a virus that can occur in babies ages 0-4yrs old and may cause hearing loss. Research is needed to learn more about hearing loss and its effect on language development. The information will help us understand the best types of care that improve the health of children with CMV. (IRB#: IRB_00151251)
Heart Rate and Mobility for People with Brain Injury
This study will test how wearing a heart rate monitor and mobility (movement) monitor impacts the health of people with mild traumatic brain injury. The study wants to see how brain injuries affect the ability of the body to regulate heart rate and balance during walking. People in the study will attend one two-hour visit to the study clinic for a health test. Participants will then receive a small heart rate and mobility monitor to wear for one week. Participants will receive $150 for study completion. (IRB#: IRB_00166221)
Home- and Community-Based Services for Veterans with Cognitive Impairments and their Caregivers
Veterans are at a high risk of having Alzheimer's disease and related dementias (AD/ADRD). This is because of military experiences like traumatic brain injury (TBI) and post-traumatic stress disorder (PTSD). Family members often provide care for Veterans with AD/ADRD. This allows them to live at home in their community. Research is needed to learn about these Veterans and caregivers' current needs and the best home- and community-based care services. The information we gain may aid future patients. (IRB#: IRB_00152365)
How COVID-19 has Impacted Secondary School Aged Students with Autism
COVID-19 Study
The purpose of this study is to explore the academic, psychological and social experiences of secondary school aged individuals with an autism spectrum disorder during COVID-19. (IRB#: IRB_00135759)
How do children listen in complicated auditory environments?
Children have more difficulty listening in complex environments like a classroom than adults. Children with hearing loss experience even more difficulty than children without hearing loss. Scientists and doctors do not fully understand the characteristics of the environment and the listener that makes listening difficult. Research is needed to design better methods that improve the health of people with listening challenges in complex environments. (IRB#: IRB_00126429)
How does brain function change during a treatment cycle of Botox injections for the voice disorder adductor laryngeal dystonia?
The purpose of this study is to find the locations in the brain that are affected by Botox injections into the throat muscles in patients who have adductor-type laryngeal dystonia (also known as adductor spasmodic dysphonia). Participation in this study involves brain scans along with assessments of the voice muscles. Brain scans involve 1) laying still in a scanner while resting and speaking and 2) wearing a head cap while seated and reclined during speaking tasks. Assessment of voice muscles involves small needles inserted into muscles in the voice box. All procedures are well-tolerated by most people. Participants with laryngeal dystonia will have 4 brain scans (2 of each kind) and 2 voice muscle assessments over 1 Botox cycle (approximately 3-4 months). A second purpose of this study is to evaluate a specialized speech therapy program for treating laryngeal dystonia. Therapy will take place over 6 months (2 Botox cycles) and will incorporate in-person or virtual session along with home practice. Some participants may be eligible to participate by completing only some portions of the study. (IRB#: IRB_00143531)
How does kidney blood flow affect heart failure?
We want to learn how blood flow in the kidneys might affect heart failure. We will test some people with normal heart function and some with stable heart failure. We will also test some people with diabetes. The tests are a blood test, a urine test, an MRI, an echocardiogram, and an ultrasound. We will also collect information about the medications you take and other medical problems you might have. (IRB#: IRB_00154546)
Identifying Deceased American Service Members; Prisoners of War (POW) and Missing in Action (MIA)
This study is collecting a persons wisdom teeth/third molars (teeth located near the back of the mouth) from people across the United States. The study team will use the teeth to learn more about the life history of people from different places in the country. The information may help identify American military prisoners of war and missing in action. (IRB#: IRB_00139648)
Improve Magnetic Resonance (MR) Imaging for a Peoples Diagnosis and Therapy
The purpose of the study is to learn if new hardware and/or software for Magnetic Resonance Imagining (MRI) helps doctors better see into a persons body with or without diseases. Research is needed to improve the quality of pictures and shorten a person's scanning time. Including the length of stay in the magnet (the machine where a person is scanned). The information we gain may aid future patients. (IRB#: IRB_00076123)
Improve Technology to Rehabilitate People with Non-Mobility and Mobility Impairment
Smart Technology may be used to help rehabilitate people from injuries. Technology can measure a persons movements such as how they walk. There is a new technology that might reduce the cost and amount of time required to recover from an injury. Research is needed to see if the new technology improves rehabilitation for adults with non-mobility and mobility. (IRB#: IRB_00160259)
Improving Assessment of Executive Functioning in Culturally Diverse Older Adults
Neuropsychological evaluations are often used to help doctors determine how well an individual can live independently. However, many of the tests neuropsychologists use were developed on non-Hispanic White individuals and are not as accurate in culturally diverse individuals. The goal of this study is to determine which measures are best for assessing functioning in culturally-diverse individuals so that neuropsychologists have a better understanding of how improve the accuracy of their assessments. (IRB#: IRB_00145891)
Improving Congenital Heart Disease Care for Adolescents and Young Adults
Congenital Heart disease (CHD) is one of the most common birth defects with most major effects diagnosed in infancy. Because there is no cure for CHD it is a lifelong chronic illness. Research is needed to understand the needs of people with CHD as they transition from child to adulthood. This information will improve the care and quality of life for people with CHD. (IRB#: IRB_00149991)
Improving Corneal Ulcer Outcomes
Undiagnosed corneal infection leads to blindness. Research is needed to develop a new testing method for finding types of corneal ulcers to stop the risk of blindness. The information we gain may aid future patients. (IRB#: IRB_00155406)
Improving Dementia Care with Hispanic/Latino Communities
Dementia is a disease that affects a persons memory, behavior, and movement. This study will co-design a Spanish-language advanced care planning (ACP) intervention for Hispanic/Latino people living with dementia and their care partners. The study will then test the impact of the intervention on Spanish-speaking Hispanic/Latino people living with Alzheimer's disease or related dementias. The participants who co-design the intervention will meet in groups on Zoom (a way to meet using technology such as a computer). Being in this part of the study requires meeting about 8 times over about 3 years. The study will then test the co-designed Spanish/Latino Alzheimer's disease or related dementia intervention with the specific population. (IRB#: IRB_00177351)
Improving Health Insurance Literacy for Young Adult Cancer Survivors
Health insurance can be difficult for young adults with cancer to find answers to questions about their health insurance plan. This studys purpose is to help young adult cancer survivors understand their health insurance and costs. People in this study are required to complete 3 online surveys over 12 months. Each survey will take about 20 minutes. Participants will be paid for completing each activity. Some participants will receive a digital informational booklet about health insurance while other participants will receive this booklet and also complete 4 health insurance support sessions with a navigator. Sessions will be completed on Zoom and last about 45 minutes. (IRB#: IRB_00164028)
Improving MRI for People with Heart Disease
People with heart disease may need an imagining scan known as an MRI. Research is needed to improve MRI methods used for finding heart problems and better determining what is normal and what is a disease. These include myocardial fibrosis. The thickening of tissue in heart muscles. The information we gain may aid future patients. (IRB#: IRB_00154019)
Impulsiveness and Suicide of Young Adults with Bipolar Disorder
Bipolar disorder may increase suicide risk, especially in young adults. Impulsiveness and suicidal thoughts can create a higher risk and make it harder to control thoughts of suicide. Research is needed to learn how bipolar disorder may be connected to impulsiveness and suicidal thoughts. The information we gain may aid future patients. (IRB#: IRB_00137442)
Inflammation as People Age
As a person gets older, immune cells in your blood can create inflammation causing swelling and pain in the body. Research is needed to learn the health and effects of these cells. The information we learn in this study will help us design better ways to aid future patients. (IRB#: IRB_00153158)
Influence of Product Bundle Pricing on Customer Choice
Products are often sold with other products in a bundle for a discounted price. Fast-food combo meals, furniture sets, and vacation packages are all examples of discount product bundling. How bundle prices are shown to customers may influence whether the customer chooses to purchase the product and how the customer thinks about the brand and product. The goal of this study is to better understand the influence of bundle pricing on customer choice and attitudes. Study participants will be asked to consider one or multiple product bundles and provide their feedback about the products and brands. Basic demographic information will be collected such as age, race/ethnicity, gender test whether effects vary by customer demographics. Questions will appear as multiple choice, scale responses, fill-in-the-blank, or short answer. (IRB#: IRB_00175316)
Inhaled Treprostinil: A Study Drug for People with Fibrotic Lung Disease
Idiopathic Pulmonary Fibrosis (IPF) is a rare illness that severally affects the lungs making it hard to breathe. Inhaled Treprostinil is a study drug for people with IPF. The medicine is given by breathing into the lungs using a machine called a nebulizer (breathing device). The machine turns the medicine into a mist to breathe into your lungs. Research is needed to learn the safety and effectiveness of the drug and provide or continue to provide inhaled Treprostinil for people previously in the RIN-PF-301 (TETON) study. (IRB#: IRB_00162671)
Intergenerational Differences in Mental Health within South-Asian Households
Intergenerational (people of many ages) differences may have mental health perspectives differ from parent to child. This study will explore how intergenerational mental health views differ from parent to child. Including the effects of family dynamics and the personal mental health of family members. Specifically, in homes with South-Asian immigrant parents and their second-generation children. People in the study will complete surveys and interviews. (IRB#: IRB_00173613)
INZ-701: A Study Drug for Infants with Generalized Arterial Calcification of Infancy (GACI) due to ENPP1 Deficiency
Generalized Arterial Calcification of Infancy (GACI) is a rare genetic disease that causes calcium buildup in the blood vessels throughout the body. This calcium buildup narrow these blood vessels, and especially the arteries, which often leads to high blood pressure, heart disease, strokes, and kidney disease. One of the main genetic causes of GACI is the lack of an enzyme called ENPP1. INZ-701, is a study drug to help infants with this ENPP1 Deficiency. Research is needed to learn the safety and effectiveness of INZ-701. The information we gain may aid future patients. INZ-701 is a medication given under the skin. In this study, participants would receive study medication at least once a week. Study visits are in person and weekly for the first month and then every 4 weeks. (IRB#: IRB_00158538)
IONIS: A Study Drug to Improve Symptoms of FUS-ALS Patients
IONIS is a potential drug to reduce the body's production of the FUS protein that may contribute to ALS. Scientists and doctors need to learn the effectiveness, safety, tolerability, and breakdown of this medication to improve the symptoms of people with ALS. (IRB#: IRB_00144685)
IROC: Improving Care for Children Who Have Kidney Transplants Due to Kidney Disease
Kidney disease is when blood in the body is not filtered creating extra fluid that can cause serious health issues such as heart disease or stroke. The study wants to see how to improve care for children who have kidney transplants (a surgery that removes an unhealthy kidney and replaces it with a healthy kidney). Improving Renal Outcomes Collaborative is a network of patients, families, caregivers, and researchers that provide data to find better ways to care for children with kidney transplants. Participants in the study will share health data to be collected into a secure database to develop new methods that improve care for children with kidney transplants. (IRB#: IRB_00138538)
Lanifibranor in adult patients with non-cirrhotic non-alcoholic steatohepatitis (NASH) and fibrosis 2 (F2)/fibrosis 3 (F3) stage of liver fibrosis
This Phase 3 study is conducted to evaluate lanifibranor in adults with NASH and liver fibrosis stage 2 or 3 and consists of 2 sequential parts, Part 1 and Part 2, with the following primary objectives and primary endpoint for the definition of treatment effects. (IRB#: IRB_00145070)
Laser Evoked Potentials (LEP) in Patients with Low Back Pain and Healthy Volunteers
People with low back pain may need testing for diagnoses and treatment evaluations. Research is needed to assess if more quantitative measures such as laser evoked potential (LEP) and quantitative sensory testing can be used to tease out differences in patients with low back pain problems and better determine the treatment outcomes. The information we gain may aid future patients. (IRB#: IRB_00158608)
Learning and Memory
Building new memories is known to be a long process. However, studies do show new information can be gained quicker if combined with previous knowledge. Research is needed to learn if young healthy adults build memory faster by attaching present experiences with the past. The information we learn may aid future patients. (IRB#: IRB_00155080)
Learning New Movements Across the Lifespan
The goal of this research is to provide a comprehensive investigation into how novel movements are learned and subsequently stored into long-term memory across the human lifespan. (IRB#: IRB_00136894)
Lifestyle Change Among Women at Risk for Heart Disease and Diabetes
More than half of women of childbearing age may be at risk for heart disease and diabetes. Research is needed to know if women who participate in lifestyle change programs have better health in future pregnancies. To do this we first want to learn women's knowledge about their risk of diabetes and heart disease. Second, we want to know what factors women think may help or prevent them from participating in a healthy lifestyle program. The information we gain may aid future women. (IRB#: IRB_00146361)
Liver Transplantation in Patients with Cirrhosis and Severe Acute-on-Chronic Liver Failure (ACLF)
Cirrhosis is a disease that causes scar tissue to form in the liver. ACLF is a chronic liver disease that causes liver failure. Research is needed to better understand how people respond to liver transplantation with the combination of these conditions. The information we learn will help us improve the care of people with Cirrhosis and Severe Acute-on-Chronic liver disease. (IRB#: IRB_00142539)
Long Covid-19 and Cognitive Symptoms
Many people experience long COVID cognitive symptoms after recovering from a COVID-19 infection. How to treat people with long COVID cognitive symptoms is not fully known. Urgent research is needed to create safe and effective ways to help people with this condition. The information we gain from your participation may aid future patients by informing researchers what cognitive functions are impaired by long COVID, and whether digital cognitive training may treat those functions. (IRB#: IRB_00173438)
Long-Term Follow-Up of Patients Who Received Lentiviral-Based CAR-T Cell Therapy
People with specific types of cancer such as leukemia and lymphomas may receive Lentiviral-Based CAR-T Cell Therapy. This is to help improve the symptoms of this disease. Research is needed to learn the long-term safety and effectiveness of the therapy. The information we gain may provide further guidance to patients, doctors, and researchers. (IRB#: IRB_00079262)
Low-Cost Platelet-Rich Plasma for Managing Orthopedic Complications of Bleeding Disorders
Orthopedic complications can be injuries or diseases that affect the bones, muscles, and joints. Hemarthropathy is due to bleeding disorders, most commonly hemophilia, and can result in severe issues related to chronic amounts of blood in the bodys joints. This causes swelling, pain, and loss of joint function. A serious barrier to treating many patients with bleeding disorders creates higher health risks and costs. Platelet-rich plasma (PRP) injection is a method that can reduce the cost of care while still offering a similar standard of care for patients. This study intends to show that low-cost PRP can be done safely in patients with bleeding disorders, without the need for expensive equipment, while monitoring patient treatment results. People in the study will receive injections for joint conditions. Being in the study requires attending 1 to 2 in-person visits at the study clinic. People will also complete surveys using email, text messages, in person, and/or on the phone. Participation lasts about 6 months. (IRB#: IRB_00177846)
Magnetic Resonance Imaging (MRI) in Atherosclerotic Disease of the Carotid Artery
Atherosclerotic Disease is a buildup of fat, cholesterol, and other substances on artery walls. An MRI is a way to see places that may have buildup. Research is needed to improve the way an MRI automatically and accurately sees inside the artery walls. The information we gain may aid future patients. (IRB#: IRB_00143315)
MAINTAIN YOUR WEIGHT STUDY
If you have intentionally lost at least 5% of your highest weight in the last 2 years, you may qualify for a study that provides coaching to support you in maintaining your healthy habits & weight loss. The coaching will be provided to participants at no cost. (IRB#: IRB_00132802)
Massage and the Brain
In 2018, over 47.5 million adult Americans received at least one massage. Although massage is commonly used to improve overall health and symptoms of depression and anxiety, the effects on the brain are unclear. This study will use fMRI, an image taken to show how the brain responds to whole-body massage. The information we gain may aid future patients. (IRB#: IRB_00155218)
Massage for Generalized Anxiety Disorder (GAD)
Generalized Anxiety Disorder (GAD) is very upsetting and disabling for people. Massage is known to decrease anxiety. Research is needed to study the effects massage has on symptoms of anxiety and the brain. The information we learn will improve our knowledge of massage to provide more options of care for people with GAD. (IRB#: IRB_00153327)
Meal Timing for Cancer Prevention of Native Hawaiian and Other Pacific Islander Families
Native Hawaiians and other Pacific Islanders face a higher risk of obesity-related cancer than other racial/ethnic groups, especially cancer of the uterus, and a higher possibility of cancer risk factors like poor diet and metabolic (how food creates energy) dysfunction. The study will test culturally tailored dietary (eating) strategies for effects on metabolic (how food creates energy) health and mental health among NHPI women at risk of obesity-related cancer, such as colon and breast cancer. The information will help to better understand strategies to improve the health of Native Hawaiian and Pacific Islander populations. People in the study will participate in group discussions that last 60 to 90 minutes. Participants will also complete surveys and use a cell phone to track their health. Being in the study will last about 13.5 months. Medical tests will be done to track the health of participants. Participants are paid for their time in the study. (IRB#: IRB_00166790)
Measuring Language Between People with Aphasia and Neurotypical Adults
The study's purpose is to measure event-related potentials (ERPs) of people with aphasia or neurotypical adults. Aphasia is when a person may be unable to speak well after a brain injury such as a stroke and head trauma. Neurotypical is when a person has standard brain functions such as the ability to speak or write without much effort. An ERP is a brain response to when a person may feel, think, speak, write, and move. An ERP is measured through an electromagnetic encephalogram (EEG). An EEG is a cap worn on top of the head with electrodes attached to the cap. The electrodes are a safe way to allow a small amount of electricity to measure a persons brain activity. Participants will read sentences while having their brain activity measured with an EEG. This study will help us better understand language challenges and develop effective ways of language recovery for people with aphasia. Participants will receive $10 an hour for in-person participation at a University of Utah clinic or online using a computer or phone. (IRB#: IRB_00149485)
Metformin and Muscle Health Recovery
Times of physical inactivity such as illness, recovery from surgery, or injury in older adults may harm muscle health. Research is needed to learn of ways to improve the muscle response to physical activity and recovery. We will determine if metformin, a diabetes drug, improves muscle recovery during physical inactivity. The information we gain may allow us to better design ways to help muscle health when older adults or those who are overweight become physically inactive and have rehabilitation. (IRB#: IRB_00175808)
Metformin for People with Fibromyalgia Symptoms
Fibromyalgia may cause people serious chronic pain. It is very difficult to help people with this pain. Metformin is an approved drug. Research is needed to learn if metformin helps people with pain from fibromyalgia. The information we gain may aid future patients. (IRB#: IRB_00160543)
Migraine Progression and Prevention
Migraines progress becoming more severe or frequent. Research is needed to study if the sensitivity to a persons environment such as light, touch, and sound can cause migraine progression. We hope to understand what makes migraine progress from not often to almost a daily problem. The information we gain may help us create better ways for people to prevent chronic migraine. (IRB#: IRB_00161605)
MODEL Study: SB-01, A Study Drug for People with Degenerative Disc Disease in the Lower Back of the Spine
Degenerative disc disease can occur in the lower back of a persons spine. This disease can cause severe back pain and cause disability. SB-01 is a study drug to help people with this disease. Research is needed to study the safety and effectiveness of this drug. The information we gain may aid future patients. (IRB#: IRB_00154298)
Moment-to-Moment Changes in Visual Sensitivity
Sensitivity to visual stimuli (response to eye activity) varies depending on how the brain processes information. The purpose of this study is to learn what adds to moment-to-moment changes in the visual system. This system of the eye and brain allows people to see light. This study will track the movements of the eye and pupil to report and detect faint visual targets on a computer monitor. People in the study will have eye movement and pupillary fluctuations (change of pupil in the eye) tracked using an eye-tracking camera. Participants will sit in an office chair with their heads placed on a chin stand. Participants will then stare at a computer monitor without blinking eyes for 8 to 10-second intervals. Being in the study requires attending about a 1-hour in-person visit at the study clinic. Participants could be asked to return to complete more sessions, up to 6 in total. (IRB#: IRB_00177167)
Motor Learning and Brain Development
Motor learning is how a person functions using the brain. Young adult brain development is known as the best motor learning and memory behaviors. Some studies show a childs brain may be better at these. Research is needed to find if a childs brain is greater at motor learning and memory-related behaviors. The information we gain may aid future patients. (IRB#: IRB_00155118)
MPS VII - Disease Monitoring Program
This DMP will follow the disease in all enrolled individuals with MPS VII, regardless if they are receiving or not receiving Mepsevii. The DMP will observe how your disease changes over time by using several tests and questionnaires, which will be discussed later in this form. For those individualss who are receiving Mepsevii, this DMP will assess long-term effectiveness and safety of Mepsevii. (IRB#: IRB_00137496)
Multiple Sclerosis (MS), Autoimmune Diseases, and Infection
The cause of Multiple sclerosis (MS) and autoimmune diseases is unknown. The effects of these can severely hurt a persons brain, spinal cord, and body. We want to understand how infections may relate to the diseases. The information we learn can aid future patients. (IRB#: IRB_00047316)
NERVE TRANSFERS TO IMPROVE UPPER EXTREMITY FUNCTION AND QUALITY OF LIFE IN TETRAPLEGIC PATIENTS
The purpose of this study is to gather information about the treatment of Spinal Cord Injury (SCI) through the use of a surgical procedure known as a nerve transfer. SCI is a devastating condition which is thought to affect nearly 40 cases per million persons annually in the US. More than 50% SCI occur in the cervical spine (i.e., tetraplegia), resulting in some loss of arm and/or hand function. Nerve transfers are used to improve upper extremity and hand function in patients who have suffered from SCI. This is a treatment option that is available to all (appropriate) patients, and participation in this study is not necessary to receive this treatment. Participation in this study is voluntary, and is available only to those who meet certain eligibility criteria. These criteria will be reviewed on a case by case basis by the University of Utah Department of Neurosurgery's study team as potential participants express their interest in the study. Various appointments and/or diagnostic procedures may be scheduled in order to ensure the eligibility of potential patients. There is no financial cost to patients (aside from the standard costs of care) who participate in this study, and there are no direct financial benefits provided for doing so. Participants will be followed after the procedure both by the surgeon and the physical therapy team. This study does provide funding for the physical therapy services utilized in the long-term follow up phase, but this funding is limited. So participants are encouraged to schedule these visits appropriately. The information provided on this page is not exhaustive, so those who are interested in this study are encouraged to contact our study team to discuss any questions they might have. You can do this by contacting the study coordinator, Kirby Taylor, via telephone or email. (IRB#: IRB_00126462)
New Magnetic Resonance Imaging (MRI) Software to Improve Diagnosis of People with Neurovascular Diseases.
Magnetic Resonance Imaging (MRI) is a way to form pictures inside of a persons body. A new MRI software has been designed to improve the quality and diagnosis of neurovascular diseases in the brain and surrounding areas. These diseases can cause problems in the muscles and nerves of a persons body. We want to learn if new MRI software creates better pictures to help people with neurovascular diseases. The information we gain may aid future patients. (IRB#: IRB_00162281)
Novo Nordisk: NASH and semaglutide
We are doing this study to see if the medicine called semaglutide can help patients with NASH get better and reduce their risk of future liver complications. NASH is a disease where fat, inflammation and scar tissue build up in the liver. Semaglutide may improve these liver damages. By improving liver damage it might be possible to prevent future liver complications. Semaglutide is already used by doctors to treat patients with type 2 diabetes in many countries. It is also used in research studies of patients with obesity and of patients with different stages of NASH. (IRB#: IRB_00139687)
Obinutuzumab: A Study Drug for Childhood-Onset Idiopathic Nephrotic Syndrome (INShore study)
Idiopathic Nephrotic Syndrome is a type of kidney disease. This condition may require many hospital visits, new medications, and relapses. Obinutuzumab is a study drug to help improve the lives of children and young people with this issue and their families. Research is needed to learn how safe and effective Obinutuzumab is when compared to a currently used common drug. The information we gain may aid future patients. (IRB#: IRB_00161524)
Online Psychology Studies
We want to learn how different people behave in complex situations. These complex situations are about how you make choices and what affects your choices. We will ask people in this study to do tasks on a private, online site that we created. We will compare this to how people with epilepsy do the tasks. We hope to better understand how to help people with epilepsy. (IRB#: IRB_00175849)
Orvepitant: A study to Reduce Severe Coughing for People with Idiopathic Pulmonary Fibrosis (IPF)
Idiopathic pulmonary fibrosis (IPF) is a condition that causes scarring of the lungs and severe coughing. Orvepitant is a study drug to reduce chronic coughing for people with IPF. Research is needed to learn the safety and effectiveness of the study drug. Our hope is to provide long-lasting control of chronic cough and a better quality-of-life. The information we gain may aid future patients. (IRB#: IRB_00152984)
Patient and Caregiver Perceptions of Family Wellbeing for Vascular Surgery
Vascular surgery may be done to treat a wide range of people with heart and blood flow issues. Many patients with this procedure can be at risk for other health problems and are over the age of 65. The purpose of this study is to learn more about the needs of the family well-being of vascular surgery patients. This will help doctors better understand decision-making for the family's well-being. People in this study will complete a one-time interview and one-time questionnaires. The interview will be conducted over the phone. Participants will be given a total of $100 for completion of the interview and questionnaires at each time point before and after surgery (IRB#: IRB_00166345)
Patients After a Stroke who Have Weakness in Either Arms or Legs
Paresis can occur after a person has a stroke causing weakness in either the arms or legs. People who have paresis are at risk of having spasticity. This is when the muscles stiffen or tighten without control and can cause pain. The study wants to see what patients 12 months after the first stroke have spasticity. Participants in the study will complete surveys by phone or online (such as using a computer) and attend in-person study visits. If allowed, the study visits may happen at home. The amount of time spent in the study varies and can last up to 18 months after the first stroke. Participants will be paid for being in the study. Medical information will be collected to track the health of participants. (IRB#: IRB_00169101)
Perceptions of Risk Living Near Toxic Release Facilities
Living near facilities such as buildings that release Toxic Chemicals can have harmful health effects on the people that live near the areas. This study will learn what people experience living in the areas. People in the study will participate in interviews and complete surveys. The information learned will help to better understand what people think about where they live and when they experience a toxic event. (IRB#: IRB_00169584)
Percutaneous Peripheral Nerve Stimulation (PNS): A Therapy for People with Chronic Low Back Pain (LBP)
Chronic low back pain (LBP) is a major health concern for many people. Many current therapies to help LBP do not work well. Percutaneous peripheral nerve stimulation (PNS) has been shown to relieve LBP and improve quality of life. Research is needed to learn the safety and effectiveness of percutaneous PNS. The information we learn may aid future patients. (IRB#: IRB_00132843)
PHINDER: A study to find ways to detect Pulmonary Hypertension earlier in patients with Interstitial Lung Disease
Having interstitial lung disease (ILD) puts a person at a higher risk for a condition called pulmonary hypertension (PH). Pulmonary hypertension is high blood pressure in the blood vessels that supply the lungs, which in turn can put a strain on the heart. The study will evaluate the best tests to screen for pulmonary hypertension in patients with interstitial lung disease. The study wants to see the most effective screening tests, promote awareness, and encourage screening. Being in the study requires up to 28 days with several visits to the study clinic. Medical tests will be done during the study to track the health of participants. (IRB#: IRB_00169643)
Physical Inactivity and Muscle Health Recovery
Times of physical inactivity such as illness, recovery from surgery, or injury in older adults and those who are overweight may harm muscle health. Research is needed to learn how different markers such as hormones and proteins in the blood and muscle respond to physical activity and recovery. The information we gain may allow us to better design ways to help muscle health when older adults or those who are overweight become physically inactive and have rehabilitation. (IRB#: IRB_00130232)
Platelet-Rich Plasma for Labrum Tears of the Hip
Platelets are small cells found in the blood that help form clots and stop bleeding. Platelet-rich plasma is blood that contains more platelets than normal and can be given to help people with pain. Tears of the Labrum to the hip (the cartilage "suction cup" that holds the ball to the socket of the hip) cause hip pain. The study wants to see if a portion of the patient's blood, the platelets, will help relieve hip pain and function. Participation requires completing surveys by email, text message, in person, and/or by telephone. Medical tests will also be done to track the health of participants. Participants will receive a gift card for the time spent in the study. (IRB#: IRB_00173470)
Postnatal Depression of Unmet Breastfeeding Goals for African American Women
African American women with unmet breastfeeding goals are at a higher risk for postnatal (after birth) depression. To reduce the rates of postnatal depression and promote well-being after giving birth, it is important to understand the emotional experiences of African American women. This will help identify unmet breastfeeding goals and the support needed to reach the goals. Participants in the study will complete a 10-minute online survey. Participants will also attend a 50-minute interview using Zoom (technology used on a device such as a computer or phone). Participants will be paid for their time in the study. (IRB#: IRB_00176280)
Preventing Firearm Suicide Deaths Among Black or African American Adults
The purpose of this study is to learn from community members and health professionals about firearm safety and how health systems can better help to prevent firearm suicides in Black or African American communities. Interviews will be conducted with African American community members who own firearms to better understand how they feel about discussing firearm safety with health professionals. Interviews will also be conducted with health professionals to identify ways to improve Counseling on Access to Lethal Means (CALM) for Black or African American adults. Each interview lasts up to 60 minutes and may be conducted over Zoom or in person. All information is confidential. (IRB#: IRB_00169397)
Preventing Perinatal Depression using an Online Intervention in a Healthcare System
Women may suffer from depression before and after childbirth. This is called perinatal depression. Access to mental health resources can be difficult in both urban and rural areas. An online prevention program as part of a healthcare system may be a tool to access education and mental health resources. Research is needed to learn if using this tool is effective at preventing perinatal depression. The information we gain may aid future patients. (IRB#: IRB_00159109)
Prevention for Adults at Risk of Atherosclerotic Cardiovascular Disease (ASCVD)
Older adults may be at risk for atherosclerotic cardiovascular disease (ASCVD). This is the buildup of fats, cholesterol, and other substances on the walls of the artery. Statin is a medication that can lower the risk of cardiovascular disease. Research is needed to learn the benefit of using statins in the prevention of ASCVD. This will help us develop a model for assessing risk factors for ASCVD. The information we gain may aid future patients. (IRB#: IRB_00155180)
Prevention for People with Type 2 Diabetes
A persons lifestyle may help prevent diabetes. A persons lifestyle and overall health may be influenced by their partner. Research is needed to learn how useful and successful a diabetes prevention program is for improving the lifestyle of patients at high risk for type 2 diabetes and their partner. The information we gain may aid future patients. (IRB#: IRB_00166946)
Prevention for People with Type 2 Diabetes
A persons lifestyle shows to help prevent diabetes. A persons health may be influenced by their partner. Research is needed to learn how useful and successful a diabetes prevention program is when educating a patient with type 2 diabetes and their partner. The information we gain may aid future patients. (IRB#: IRB_00143079)
Promoting Health Among Native Americans
Chronic diseases such as heart disease, cancer, and diabetes are the leading causes of death, disability. These chronic diseases can be preventable with healthy behaviors. Many diseases begin in a persons gut (stomach). Native Americans such as the Navajo people are at a higher risk for chronic diseases. The study wants to design a culturally specific nutrition education program that promotes health. There are two phases to the study. Phase 1 requires people to complete surveys and attend 2 in-person study visits at a clinic (the second visit is optional). This phase lasts 1-2 years. People who participated in Phase 1 will decide if they want to participate in Phase 2. Phase 2 requires people to participate in a nutrition education program. The program meets once a week for 12 weeks. Medical tests for both phases will be done to track the health of participants. (IRB#: IRB_00173653)
Radiofrequency Ablation for People with Sacroiliac Joint Pain
Radiofrequency ablation (RFA) is a way to help people with lower back pain. The pain is caused by swelling or arthritis in the sacroiliac joints. This is where the lower spine and pelvis connect in a persons back. Research is needed to compare 2 types of RFA electrodes (an object that allows electricity to enter and leave a persons body safely). We want to learn which electrode works best in reducing joint pain. The information we gain may aid future patients. (IRB#: IRB_00150067)
Ravulizumab: A Study Drug for Infants, Children, and Young Adults Ages 1 month to 18 years old with Thrombotic Microangiopathy (TMA) after Hematopoietic Stem Cell Transplant (HSCT
Thrombotic Microangiopathy (TMA) is blood clots that form in the body from damaged cells. Hematopoietic stem cell transplant (HSCT) is when other cells are used from a persons body to create normal blood cells. Ravulizumab is a study drug to help infants, children, and young adults ages 1 month to 18 years old with this disease after having HSCT. Research is needed to learn if the drug is safe and effective. The information we gain may aid patients. (IRB#: IRB_00135225)
Realize Trial for Drug resistant focal onset seizures
In this study, doctors want to find out if an investigational drug called CVL-865 is effective in decreasing the number of focal onset seizures, also known as partial seizures, without causing too many side effects. (IRB#: IRB_00130130)
Reflexes and Electrical Stimulation after Neurological Injury
The purpose of this study is to learn how reflexes (a muscle reaction in the body) change in the lower back after neurological (the body's nervous system) injuries such as stroke, spinal cord injury, or leg amputation using non-invasive electrical stimulation (a small pad placed on the skin outside of the body that sends electricity to a muscle). We want to learn how and what a person feels from the stimulation and if it helps improve stability during standing and walking. We also want to learn if there are changes in pain, quality of life, and spasms (a sudden muscle movement in the body) after receiving this stimulation. People in this study will be placed into two groups based on their condition. Group 1 is people who have had a transtibial (below knee) amputation. Group 2 is people with chronic transtibial (below the knee) amputation pain, stroke, or spinal cord injury affecting at least one leg for at least 6 months before participation. Being in the study requires up to 9 weeks and 4 study visits. Each visit will last up to 6 hours depending on what needs to occur at the visit. Medical tests will be done during the study to track the health of participants. Participants will be paid $75 for participation. (IRB#: IRB_00167330)
Registry for Adenomas of the PItuitary and related Disorders (RAPID)
This study is a surgical registry for patients who undergo surgical resection of pituitary adenomas. The registry allows surgeons and researchers to obtain more accurate data from patients because it is prospective, meaning it data is entered as the patient is treated. One problem with all prior studies is that patient charts are reviewed after treatment which can result in inaccurate data and bias. Clinical data such as visual function, endocrinology function, surgery time, and length of stay will be acquired in addition to other variables. Samples of removed tumor will be stored in the Huntsman Tumor Biobank. Patients will also be provided quality-of-life surveys, brief evaluations done at the time of clinic follow-up or by email, that allows surgeons to better understand how surgical treatment is helping their patients' life at home, ability to reenter the workplace, etc.The purpose of this study is to evaluate best practices, improve the accuracy of epidemiology information, and improve patient outcomes. This registry is part of a multicenter study where the top centers of excellence in the treatment of pituitary adenoma are collaborating to study their data together. Future plans for the registry are to expand to other types of skull base tumors to better understand patient treatment and improve outcomes. (IRB#: IRB_00144784)
Relationship between Pupillary Function, Olfaction, Balance, and Cognition in People with Parkinsons Disease and Essential Tremor
The purpose of the study is to use simple tools that could be used in a health clinic to identify people with Parkinson's disease and essential tremor. People with these health issues are at risk of falling or having dementia. We want to explore the relationship between the pupillary light reflex (the way the pupil constricts when exposed to light) and olfaction (smell) with balance and cognition in people with Parkinson's disease and essential tremor. (IRB#: IRB_00158420)
Rivaroxaban Transfer into Human Milk After Childbirth
Right after a female gives birth to a baby the female could need to take a blood thinner medication for their health. The study will test to see if giving a female right after the birth of their baby a low dose of rivaroxaban (a common blood thinner) medication by mouth passes into human milk. The information will help to better understand if rivaroxaban can be used by the female when breastfeeding a baby. Being in the study requires females who are NOT or will STOP breastfeeding or pumping breastmilk to take two low doses of the rivaroxaban (24 hours apart) by mouth. Then the breastmilk and blood samples will be collected. The study will test the samples to see if rivaroxaban passes into human milk, and if so, at what amount. Participants will be paid for being in the study. (IRB#: IRB_00167245)
Rozanolixizumab: A Study Drug for People with Myelin Oligodendrocyte Glycoprotein (MOG) antibody associated disease (MOG-AD)
Myelin Oligodendrocyte Glycoprotein (MOG) antibody-associated disease (MOG-AD) may inflame a persons central nervous system severely affecting nerves in the eyes, brain, and spinal cord. Rozanolixizumab is a study drug to help people with MOG-AD. Research is needed to learn the safety and effectiveness of the study drug. The information we gain may aid future patients. (IRB#: IRB_00148171)
Safety and Therapeutic Monitoring of Brain Stimulation in Patients with Partial Epilepsy
The purpose of this research is to learn more about 10 daily sessions of transcranial direct current stimulation (tDCS) and see if it can help to reduce the frequency of seizures (the number of seizures in a given period of time) in both adults and children with refractory focal epilepsy (epilepsy that cannot be well controlled by seizure medication). The University of Utah anticipates enrolling five patients in this study. (IRB#: IRB_00146095)
SARS-CoV-2 Vaccine Pregnancy Registry
Vaccination of COVID-19 is one of the most effective approaches to prevent the condition. Pregnant patients have been excluded from research regarding the SARS-CovV-2 vaccine. This study will compare development and behavior among children whose mothers did and did not receive the vaccine during pregnancy. Participants will complete online surveys (with an option of phone or video conferencing) related to their child's development and behavior. (IRB#: IRB_00175929)
Sensory Effects of Cryoablation After NUSS Bar Removal
When a person has a sunken chest a NUSS procedure can be done. This is when a bar made of metal is put inside a persons chest to fix it. After the NUSS bar is removed a procedure called cryoablation is done to help with pain. This study will look at the long-term sensory effects such as pain and loss of feeling from using cryoablation. Being in the study requires participants who are planning to have the NUSS bar removed. The length of study participation is a total of about 45 minutes for before and after surgery plus one additional research visit. Participants will complete surveys and have medical tests done during the study to track their health. (IRB#: IRB_00162141)
Shoulder RFA for the Treatment of Non-Surgical Shoulder Pain
Shoulder pain can cause chronic health issues and costs. Currently, there are not many options to help people with this condition. Research is needed to learn the safety and effectiveness of shoulder radiofrequency ablation (SRFA) in patients with specific shoulder pain. The information we gain may aid future patients. (IRB#: IRB_00159158)
Skill Learning Study for Teens
This study will learn more about emotions and behaviors, especially self-injury, suicide attempts, and interpersonal relationships. This study will see how teaching certain skills might help teens (ages 13 to 17 years old) and their parents during times of stress. Participants in the study will complete surveys and interviews. Some participants will also have images taken of the brain. Being in the study lasts about 10 weeks with a 6-month follow-up visit. Study visits will be in person at the study clinic some visits could be on Zoom. The information gained will help develop useful therapies for teens and parents. (IRB#: IRB_00166992)
Sleep and Cardiometabolic Disease
Cardiometabolic disease may put a person at risk of diabetes and heart disease. The amount of time a person sleeps is one factor that can cause the risk of these health issues. Research is needed to learn specific ways to improve a person's nightly sleep that may lower disease risk. The research we gain may aid future patients. (IRB#: IRB_00164764)
Sleep Study for Teenagers
Sleep problems can cause people many issues such as feeling angry, unsure, distrusting of other people, and alone. This study wants to learn how teenagers sleep and sleep patterns impact these issues and if an intervention can be helpful. Participants 13 to 18 years old (teenagers) and their parents, with a study member, will participate in online interviews using technology like a cell phone or computer. Teenagers will be given a headband to wear at night while they sleep to track sleep patterns. Teenagers and parents will complete surveys. Teenage participants will also respond to short surveys on their cell phones. Being in the study requires about 2 months of participation. (IRB#: IRB_00170667)
Social Safety on University of Utah Campus
This study will help researchers understand how different campus settings feel to first-year students from different backgrounds and life paths. An app has been developed for students to use on a smartphone. The app will collect student experiences across different campus settings such as coffee shops, study areas, and classrooms. Students can choose to make lots or ratings, or only a few, and those who commit to making 15 different ratings will receive a $50 amazon gift card at the end of the study. (IRB#: IRB_00169088)
Sofosbuvir (SOF) and Velpatasvir (VEL): Study Drugs for Pregnant Women with Hepatitis C
Hepatitis C is an infection in the liver. Sofosbuvir (SOF) and Velpatasvir (VEL) are approved drugs for people with Hepatitis C. These drugs are not approved for pregnant women with Hepatitis C. Research is needed to know the safety and effectiveness of these SOF and VEL for use in pregnant women. The information we learn may aid future patients. (IRB#: IRB_00152415)
Staccato Alprazolam: A Study Drug and Device for People with Stereotypical Prolonged Seizures
Seizure emergencies can be long-lasting and hard to control with serious results. Typically, these seizures require drugs to help stop them from happening. Staccato Alprazolam is a new drug and tool combined to help stop this seizure. Research is needed to know the safety and effectiveness of this treatment. The information we learn may aid future patients. (IRB#: IRB_00154360)
Staccato Alprazolam: A Study Drug for People with Stereotypical Prolonged Seizures
Seizures can be long-lasting and hard to control with serious results. Typically, these seizures require drugs to stop them from happening. Staccato Alprazolam is a new drug to stop this seizure. Research is needed to know the safety and effectiveness of this drug in people who have had prolonged seizures. The information we learn may aid future patients. (IRB#: IRB_00148186)
Stem Cell Transplants and Disease Prevention for Children with ALL, AML, or MDS
Acute lymphocytic leukemia (ALL) is a type of blood and bone marrow cancer. Acute myeloid leukemia (AML) is a type of blood cell and bone marrow cancer caused by too many undeveloped white blood cells. Myelodysplastic Syndromes (MDS) are a rare group of bone marrow disorders, known as blood cancer. We want to learn if patients receiving stem cell transplants from donors of any type (related, unrelated, cord, or haploidentical) with specific characteristics (different genetic make-up known as polymorphisms) will have better results than those with different transplants. We want to see if fewer diseases such as Graft v Host Disease (GvHD) and other disorders occur. The information we gain may aid future patients. (IRB#: IRB_00153852)
Stigma and Mental Health Help-Seeking of Chinese International Students
This study intends to learn Chinese International students perceptions of mental health services in the United States. This study will see whether teaching these students more about mental illness impacts their ability to seek help. Participants will complete surveys. Participation lasts about 20 to 30 minutes. (IRB#: IRB_00177892)
Stroke Protocol in Hospital Emergency Departments
An acute stroke is a serious event when a person does not have good blood flow to the brain and can cause death. This study will test a seven-part intervention to improve the accuracy of acute stroke diagnosis and the time it takes for patients requiring transfer from a Primary Stroke Center (PSC) to a Comprehensive Stroke Center (CSC) of patients seeking care in the Hospital Emergency Department. People in the study will participate in 60-to-90-minute monthly group meetings, mainly by video with some in-person, to discuss experiences, care received, and/or processes of care when seeking care in the Hospital Emergency Department. The meetings will last about 1 year with opportunities to continue participating in meetings every 2 months for about 1.5 to 3 years. (IRB#: IRB_00166192)
Study Cuffless Blood Pressure
This study is developing a new device to measure blood pressure (how the force of blood goes throughout the body). Normally people measure their blood pressure with an inflatable cuff on their arm. The new device is like a wristwatch with a sensor for blood pressure. People in this study will wear the new device while they exercise in a lab at the University of Utah. Other vital signs will be measured such as body temperature and weight and use an ultrasound machine (a way to see the inside of the body). These will help get more measurements to see if the new device works. The study session will last about 90 minutes. (IRB#: IRB_00162369)
Study for People with Acute Hepatic Porphyria
Acute hepatic porphyria (AHP) is a serious, rare, genetic disorder, that can be life-threatening and harm a person's quality of life. This study will collect data over time to see how the disease evolves. Participation requires attending routine care doctor visits and sharing medical records. AHP data will be collected at yearly doctor visits. Participants will complete a survey at yearly doctor visits. Participation lasts about 5 years. (IRB#: IRB_00144599)
Study in Parkinson Disease of Exercise
This study seeks to determine if aerobic exercise influences the progression of Parkinson Disease severity. Based on previous research, we believe that aerobic exercise may protect the brain cells from being damaged and this study hopes to provide more specific evidence regarding this potential benefit. (IRB#: IRB_00136463)
Study of Eye Diseases That Lead to Visual Impairment
COVID-19 Study
There are certain eye diseases inherited and passed on from parents. Age-related macular degeneration and glaucoma are two of these diseases. Both can create vision loss or blindness. We are doing this research to find out more about the causes of these diseases and others. This will help us to know how best to test, treat, and maybe cure them. The information we learn in this study will aid future patients. (IRB#: IRB_00010201)
Study of Revision Elbow Surgery for Nerve Pain
This study intends to better understand a persons recovery from a second elbow surgery using a commercially available implantable nerve protection device called the Axoguard HA+ Nerve Protector. This study surgery and surgical device are available as part of regular medical care. This study will see how to improve recovery from elbow surgeries like revision cubital tunnel syndrome decompressions. People in the study will have the second elbow surgery and provide information about the surgery, as well as about pain and function in the elbow, forearm, and hand. People in the study will also complete assessments and questionnaires of surgery recovery time. Being in the study requires in-person visits and some virtual visits. Participation lasts about 18 months. (IRB#: IRB_00175967)
Study Voice Tremor in People Treated with Focused Ultrasound for Essential Tremor
Essential tremor is when a part of a persons body such as a hand or arm is unsteady or shaky. Vocal tremor is when people may experience an unsteady or shaky voice. This condition may impact the mouth and throat muscles. This study will test whether people receiving focused ultrasound for treatment of essential tremors show improved voice tremors. People in this study will answer questionnaires and be observed for tremor in the face, jaw, tongue, and throat as well as using audio recordings and participant self-reporting. For those who are willing, the study will also examine the speech structures affected by tremors using nasoendoscopy (a procedure to look inside the throat and nose). Participation in the study requires some visits to a study clinic and completion of other activities will be done over the phone and online to track the health of participants. (IRB#: IRB_00164533)
Studying APS ACTION- Registry for People with Antiphospholipid Antibody-Positive
Antiphospholipid antibody-positive is a condition of the blood that causes blood clots in the body. This study is for people with this condition who have already participated in the APS ACTION Research Registry. APS ACTION is a research network that conducts clinical trials to help prevent, treat, and cure people who are Antiphospholipid antibody-positive. Participants in the study will continue previous participation to provide information that helps design and maintain a secure, web-based clinical database and repository (a central storage location). Participants have two ways to participate. One is to have a phone call or in-person visit with no blood collection. The other is to attend one in-person visit with blood collection every 12 months. Each visit lasts about 20 to 30 minutes. Participants will be followed over 10 years. (IRB#: IRB_00057718)
Studying Brain Fog and other Cognitive Dysfunction Symptoms for People with Long COVID
Post-Acute Sequelae of SARS-CoV-2 (PASC) is also known as Long Covid. This study will test three interventions for "brain fog" or cognitive dysfunction that has happened because of infection with COVID. Brain fog may cause confusion, forgetfulness, and lack of focus and mental clarity. The study wants to learn more about interventions to help people with this condition. People in the study will be randomly chosen to receive two treatment interventions delivered online to participants home technology device. People in this study will visit a clinic 3 times to complete surveys, lab tests, and brain function tests. They will also complete brain training sessions at home for 10 weeks and answer follow-up questions about their health and well-being. Participation in this study should last about 6 months. Compensation is provided for participation. (IRB#: IRB_00168634)
Studying People with Childhood-Onset Systemic Lupus Erythematosus
Childhood on-set Systemic Lupus Erythematosus (cSLE) is a complex autoimmune disease often causing pain, fatigue, and mood disturbances. This study wants to determine the risk factors of cSLE due to socioeconomic status, behavior, or access to care. The study is also gathering information about the transition period between adolescents and young adults with cSLE. People in the study will complete an annual survey over the phone or online. The survey will collect information to help create specific programs and treatments to prevent short and long-term cSLE. The information will also inform future health policy decisions about healthcare coverage for young adults with chronic illnesses. Participants are compensated for their time in the study. (IRB#: IRB_00049568)
Studying the genetic factors in smoking-induced vascular disease
Our study will determine whether people who have genetic variants in nicotine receptors have a higher risk for smoking-induced vascular disease. Then we will study the mechanisms and identify potential therapy for smokers carrying genetic variants in nicotine receptors. Our study will educate people carrying genetic variants in nicotine receptors to stop smoking and will provide potential treatments against smoking-induced vascular disease for this population. (IRB#: IRB_00167355)
Suicidal Thoughts or Behavior During and After Pregnancy
Pregnancy can be a stressful time in a womans life. This may cause women to have thoughts or actions about self-harm or suicide while they are pregnant. Research is needed to learn more about the effects of motherhood on mental health. The information we learn will help us provide better support for all women during and after pregnancy. (IRB#: IRB_00126952)
Teen Depression Therapy
Depression is a mental health condition that can cause a loss of interest in activities and function in a persons daily life. This study wants to see if therapy can help teenagers stay healthy and prevent depression from happening again. Participants will receive therapy virtually on a computer or other device using Zoom or another method, complete surveys, computer testing, and a brain scan using an MRI (a tool to take pictures of the brain). Therapy sessions will be done weekly for 10-14 sessions. Participation lasts 2 years to assess depression. Participants will be paid for time spent in the study outside of therapy sessions. (IRB#: IRB_00113733)
Test to Determine Children with Idiopathic Membranous Nephropathy (IMN)
Idiopathic Membranous Nephropathy (IMN) is a kidney disease. Research is needed to find out if blood tests predict when a child may have IMN. The information we learn will aid future patients. (IRB#: IRB_00152942)
Testing a new drug called Trappsol® Cyclo in patients with Niemann-Pick Disease Type C1
Niemann-Pick Disease Type C1 (NPC1) is a disease that may cause problems in the brain and the body. This study will test a drug called Trappsol® Cyclo in children and adults with NPC1 to see if it helps treat their disease. Participants in this study will be randomized to be treated with Trappsol® Cyclo or a placebo in an IV infusion. The IV infusion will happen in the clinic every 2 weeks. Being in this study requires up to 100 study visits at the clinic. Later in the study, participants on the placebo can be switched to Trappsol® Cyclo. (IRB#: IRB_00161309)
Testing a New Drug called Venglustat Compared to the Standard of Care on the Heart in Adults with Fabry Disease (The CARAT (EFC16158) Study)
This study will test a new drug called Venglustat compared to the usual standard of care treatment in adults with Fabry Disease. This study is for people who have heart problems (enlargement of the heart's main pump (left ventricle)). Participants in this study will be randomized to be treated with Venglustat or one of the standard of care treatments. Later in the study, participants on the standard of care treatment can be switched to Venglustat. Participants will be in the study for 2 years and 2 months. There will be several clinic visits for the study and there may be the option for some home health visits. There will also be phone call visits. (IRB#: IRB_00167895)
Testing a new drug called Venglustat to treat nerve pain and abdominal pain in adults with Fabry Disease (The PERIDOT (EFC17045) Study)
This study will test a new drug called Venglustat for treating nerve pain and abdominal pain in adults with Fabry Disease. This study is for people who have not been treated by enzyme replacement therapy or who stopped taking enzyme replacement therapy for at least 6 months. Participants in this study will be randomized to be treated with Venglustat or a placebo. Later in the study, participants on the placebo can be switched to Venglustat. Participants will be in the study for 2 years and 2 months. There will be several clinic visits for the study and there may be the option for some home health visits. There will also be phone call visits. (IRB#: IRB_00153570)
Testing a Person's Mobility
This study wants to learn more about how people who either have no neurological (brain) injuries or who have had a stroke move around on different surfaces. These include stairs and uneven ground. The study wants to improve how a person moves with challenges such as a stroke survivor. People in the study will walk on different surfaces such as slopes, stairs, and uneven ground. While walking, information will be recorded from several sensors placed across the body (on the legs, in shoes, on wrist or around the chest). These sensors help collect how participants' muscles work, how they move, and how their heart rate changes as they walk on different surfaces. Being in the study requires attending at least one in-person session that will last up to 3.5 hours. People are paid for participation. (IRB#: IRB_00171076)
Testing a Study Drug Bexotegrast for People with Idiopathic Pulmonary Fibrosis
Idiopathic Pulmonary Fibrosis is a disease that causes the lungs to scar and harden. This study will test a drug called Bexotegrast to treat people with this disease. The study wants to see if the drug will help people with the disease and is safe. People in the study will be randomly chosen to be treated with Bexotegrast 160 mg, or Bexotegrast 320 mg, or placebo. The placebo looks like the study drug but does not have the medication. Being in the study requires 8 in-person visits at the study clinic over about 58 weeks. Medical tests will be done to track the health of participants. (IRB#: IRB_00171454)
Testing a Study Drug BMS-986278 for People with Progressive Pulmonary Fibrosis
Progressive Pulmonary Fibrosis is a disease scarring the lungs causing shortness of breath. The disease worsens over time. This study will test a study drug called BMS-986278 to treat people with this disease. The study wants to see if the drug will help people with the disease and is safe. People in the study will be randomly chosen the be treated with BMS-986278 or a placebo. The placebo looks like the study drug but does not have the medication. Being in the study requires at least 13 in-person study visits at the study clinic for the first 52 weeks then every 12 weeks after up to 4 years. Medical tests will be done to track the health of participants. (IRB#: IRB_00171171)
Testing a Study Drug CMTX-101 Combined with Inhaled Tobramycin in People with Cystic Fibrosis Who Also Have Pseudomonas Aeruginosa
This is a study to evaluate the new medication CMTX-101 in combination with inhaled Tobramycin in people with Cystic Fibrosis who also have Pseudomonas Aeruginosa. Cystic Fibrosis is a rare disease that mainly affects the lungs causing lung infections. Pseudomonas Aeruginosa is a type of bacteria (germ) that can cause infections in the body such as the lungs. Infections with Pseudomonas Aeruginosa are a leading cause of respiratory (breathing) failure and death in adults. The study will see if the drug will help people with the disease and is safe. People in the study will be treated with CMTX-101 in combination with inhaled Tobramycin. Being in the study requires about 35 days of participation. Including, 7 in-person visits at a study clinic and completing surveys. There are 2 parts of the study. People of part 1 will receive CMTX-101. People in part 2 will be randomly chosen to receive CMTX-101 or a placebo. The placebo looks like the drug but does not have the medication. People cannot be in both parts 1 and 2 of the study. Medical tests will be done during the study to track the health of participants. (IRB#: IRB_00171828)
Testing a Study Drug Efgartigimod for Adults with Bullous Pemphigoid
Bullous Pemphigoid is a painful blistering disease. This study will test Efgartigimod to treat adults and adolescents with this disease. The study will see if the drug will help people with the disease and is safe. People in the study will be randomly chosen to be treated with efgartigimod or a placebo. The placebo looks like the drug but does not have the medication. The drug and placebo are taken as subcutaneous injections. Being in the study requires multiple ways of participation such as completing a study diary and attending in person at a study clinic for about 2 years. Medical tests will be done during the study to track the health of participants. (IRB#: IRB_00154051)
Testing a Study Drug TAK-755 for People with Idiopathic Thrombocytopenic Purpura (iTTP)
Idiopathic Thrombocytopenic Purpura (iTTP) is a blood disease that leads to organ failure in the body. The study will test a drug called TAK-755 to treat adults with this disease. The study mainly wants to see if the drug will help people with this disease and is safe. People in the study will be randomly chosen to be treated with a different dose strength of the study drug TAK-755. Being in the study requires attending a various number of study visits at the clinic depending on the phase of study participation. Medical tests will be done during the study to track the health of the participants. (IRB#: IRB_00169901)
Testing a Study Drug Upadacitinib for Adults and Adolescents with Abbvie Hidradenitis Suppurativa
Abbvie Hidradenitis Suppurativa is a chronic (continues over time) painful skin condition that occurs in the places where the skin folds on the body. This study will test Upadacitinib to treat adults and adolescents with this disease. The study wants to see if the drug will help people with the disease and is safe. People in the study will be randomly chosen to be treated with Upadacitinib or a placebo. The placebo looks like the drug but does not have the medication. The drug and placebo are taken as a swallowed pill. During the study some participants may switch from taking Upadacitinib or the placebo. Being in the study requires multiple ways of participation such as writing in a journal at home and attending in person at a study clinic for about 2 years. Medical tests will be done during the study to track the health of participants. (IRB#: IRB_00168703)
Testing a Study Drug Vixarelimab for People with Idiopathic Pulmonary Fibrosis and People with Systemic Sclerosis-Associated Interstitial Lung Disease
Idiopathic Pulmonary Fibrosis and Systemic Sclerosis-Associated Interstitial Lung Disease are two types of lung diseases that worsen over time. This study will test a study drug called Vixarelimab to treat people with these diseases. The study wants to see if the drug will help people with the diseases and is safe. People in the study will be placed into two groups those with Idiopathic Pulmonary Fibrosis or Systemic Sclerosis-Associated Interstitial Lung Disease. People within each group will be randomly chosen to be treated with Vixarelimab or a placebo. The placebo looks like the study drug but does not have the medication. Being in the study requires in-person study visits at the study clinic for about 59 weeks. Medical tests will be done to track the health of participants. (IRB#: IRB_00172671)
Testing a Study Drug, BMS-986278 for People with Idiopathic Pulmonary Fibrosis
Idiopathic Pulmonary Fibrosis is a disease that causes the lungs to scar and harden. This study will test a drug called BMS-986278 to treat people with this disease. The study wants to see if the drug will help people with the disease and is safe. Being in the study lasts at least 14 months and up to about 4 years. There will be at least 13 in-person visits at the study clinic in the first 52 weeks then every 12 weeks up to about 4 years. Medical tests will be done to track the health of participants. (IRB#: IRB_00171168)
Testing a Video Game to Transition Care for Teens with Congenital Heart Disease
Congenital heart disease is an abnormality in the heart. This study will test an educational game to help teens and young adults with the disease change from pediatric to adult care. People in the study will review the game and provide feedback. Being in the study requires completing a survey and attending one 30-minute session. People will be paid for participation. (IRB#: IRB_00167531)
Testing Activity of People After NUSS Bar Placement Surgery
NUSS replacement surgery (named after the surgeon) is to correct a person's sunken chest. This study will test the effects of activity after a NUSS bar placement surgery. People in the study will be assigned to one of two groups. One allows activity and the other limits activity after surgery. Both groups with receive normal care from their surgeon while being observed by the researchers for 3 months. People in the study will complete surveys at 1 month and 3 months after surgery. (IRB#: IRB_00163911)
Testing an Inhaled Study Drug Treprostinil for People with Progressive Pulmonary Fibrosis
Progressive Pulmonary Fibrosis is a disease scarring the lungs causing shortness of breath. The disease worsens over time. This study will test an inhaled (to breathe in) study drug called Treprostinil to treat people with this disease. The study wants to see if the drug will help people with the disease and is safe. People in the study will be randomly chosen to be treated with inhaled Treprostinil or placebo. The placebo looks like the study drug but does not have the medication. Being in the study requires 8 in-person study visits at the study clinic for up to 58 weeks. Medical tests will be done to track the health of participants. (IRB#: IRB_00173081)
Testing Biomarkers in People with Chronic Cough
A biomarker is a way to know what is currently happening in the body that provides signs of health conditions. Chronic refractory cough (CRC) is a cough lasting 8 weeks or longer without a known cause and/or unresponsive to typical cough treatments. This condition affects the quality of life of many people. This study will help to understand biological measure patterns such as heart rate, and respiratory (breathing) rate during interactions with staff to guide the understanding of the CRC. This will also help to better understand the underlying cause of CRC. People in the study will attend one in-person visit at a study clinic for about 3 hours. Medical tests will be done during the study to track the health of participants. (IRB#: IRB_00174890)
Testing Chronic Inflammation after Blast Exposures for Active-Duty Service Members or Veterans
This study will test chronic inflammation (when parts of the body have swelling, redness, heat, pain, and/or loss of function) in response to blast exposures in Veteran military populations. The study wants to see what is needed for blast exposure treatments to be developed in the future. The study will also help to know how age and degree of inflammation impact recovery from blast Traumatic Brain Injury. People in the study will attend one in-person study visit at a clinic for about 4 to 5 hours. Participants will complete surveys, and cognitive testing (how a person thinks), and complete a brain scan. Participant information will be collected that could relate to the brain such as age, gender, handedness, medical history, and tests about how people think. (IRB#: IRB_00157573)
Testing Combining Brain, Nerve, and Hand Stimulation for Hand Recovery of People After Stroke
A stroke causes damage to the brain and can affect mobility on one side of the body. This study will test how combining brain, hand, and nerve stimulation (activity) affects hand movement in people who had a stroke. People in the study will be interviewed and complete medical tests to measure brain, hand, and nerve responses. Being in the study requires attending in-person visits at the study clinic for about 3 to 18 sessions. (IRB#: IRB_00179089)
Testing Continuous Positive Airway Pressure for Sleep Apnea in Pregnancy
This study is testing whether obstructive sleep apnea (OSA) with continuous positive airway pressure (CPAP) in pregnancy reduces the rate of hypertensive (high blood pressure) disorders in pregnancy. The study will also test whether OSA with CPAP reduces other health risks related to pregnancy. People in the study will be randomly chosen to be placed into two groups. One group will receive weekly contact, incentives for following study procedures, and initial sleep hygiene (healthy sleeping habits) counseling. The other group will only receive initial hygiene sleep counseling. Participants will use a CPAP device to measure positive airway pressure when sleeping. Being in the study requires attending in-person visits at the study clinic with an option to attend telehealth for some visits. Participation lasts about 26 to 30 weeks. (IRB#: IRB_00110528)
Testing Dupilumab in Adults with Eosinophilic Gastritis with or without Eosinophilic Duodenitis
Eosinophilic Gastritis with or without Eosinophilic Duodenitis is a rare disease of the stomach that can cause stomach pain and other health issues. This study will test a drug called Dupilumab to treat adults with this disease. The study wants to see if the drug will help people with the disease and is safe. People in this study will be randomly chosen to be treated with Dupilumab or a placebo. A placebo does not have the medication. The drug and placebo are taken as a liquid injection (a drug given under the skin). The study has 3 parts. Part A of the study people receive the drug or placebo. In part B of the study, people receive different doses of the study drug or the placebo. In part C of the study, all people will receive the study drug. Being in the study may require up to 20 study visits at the clinic for about 1.5 years. Medical tests will be done during the study to track the health of participants. People will be paid for being in the study. (IRB#: IRB_00171641)
Testing Efzofitimod for Adults with Systemic Sclerosis Related Interstitial Lung Disease
Systemic Sclerosis (hardening or tightening of the skin)-Related Interstitial Lung Disease is a rare disease that leads to severe health conditions. This study will test a drug called Efzofitimod to treat people with this disease. The study wants to see if the drug will help people with the disease and is safe. People in the study will be randomly chosen to be treated with Efzofitimod or a placebo. A placebo looks like the study drug but does not have the medication. The drug and placebo are taken as a liquid given under the skin. Being in the study will require 9 study visits at the clinic and last up to 32 weeks. Medical tests will be done during the study to track the health of participants. People will be paid for being in the study. (IRB#: IRB_00171090)
Testing FINALE a Permanent Birth Control
This study is testing a permanent birth control called FemBloc. The treatment does not require surgery. The study wants to see if FemBloc will help people who do not wish to become pregnant now and in the future. People in the study will have a device with a small amount of the liquid study drug placed in the uterus (the organ between the hip bones where an unborn baby grows). Once the fluid is released the device is removed from the uterus. People in the study will attend both in-person visits at the study clinic and telehealth visits over a technology device such as a computer throughout 5 years. Medical tests will be done during the study to learn and track the health of participants. (IRB#: IRB_00168700)
Testing How to Improve Liver Organs for Transplantation
This is a study to find new ways to improve liver organs for transplantation in people. Transplantation of liver organs requires using livers from people who are living or have died offering to donate their liver to help someone who needs a healthy liver. Participation in the study requires taking samples of the liver while having a liver transplant. If in a rare instance, a participant goes back right after surgery or for re-operation samples will be taken again. Participants health information and medical records will also be reviewed during the study. The information is confidential and will be kept in a secure database at 7 days, 1 month, 3 months, 6 months, 1 year, and 3 years after the transplantation. (IRB#: IRB_00158105)
Testing Inhaled Treprostinil in People with Idiopathic Pulmonary Fibrosis
This study will test new a drug called Inhaled Treprostinil in people with Idiopathic Pulmonary Fibrosis (IPH). IPF is a disease that causes scarring in the lungs. The study wants to see if Inhaled Treprostinil will help people with IPF and is safe. People in this study will be randomly chosen to be treated with Inhaled Treprostinil or placebo. The placebo does not contain any medicine. Treprostinil and placebo are given by breathing the medicine into the lungs using a machine called a nebulizer (inhaling device). The nebulizer changes the medicine into a mist to breathe into the lungs. Being in this study requires about 8 clinic visits. Participation lasts about 58 weeks. Medical visits will be done during the study to track the health of participants. (IRB#: IRB_00143600)
Testing M6-C Artificial Cervical Disc Compared to Anterior Cervical Discectomy and Fusion
Anterior Cervical Discectomy and Fusion (ACDF) is minimal surgery to treat people with pain in areas such as the neck and/or arm. The M6-C Artificial Cervical Disc could be another option for treating this condition. This study will compare the 2 treatments for adults with this condition. The study wants to see if the M6-C Artificial Cervical Disc will help people and is safe. People in the study will have ACDF surgery as a treatment for their neck and/or arm pain by a neurosurgeon or orthopedic surgeon at a University of Utah Health facility. Participants will be followed afterward by the surgeon, their clinical team, and a study coordinator. This follow-up will be done to collect information on recovery, pain reduction, improvement of function, and other patient feedback about the ACDF surgery. The ACDF surgery information will then be compared to another group of patients at other sites who have the M6-C Artificial Cervical Disc instead of ACDF surgery. People in the study who have ACDF surgery will attend follow-up visits with the doctor for about 24 months and possibly up to 5 years. (IRB#: IRB_00161627)
Testing Meditation Group Therapy for Chronic Low Back Pain
This study is comparing therapy to treat people with chronic (constant) low back pain. The study is testing usual care for people using opioids (medication to treat people's pain) versus usual care for people using opioids with meditation-based therapy (mental training involving focusing the mind to cope with pain, stress, and emotions). The study wants to better understand how well the usual care with meditation-based therapy works and if it creates changes in brain activity over time. People in the study will be randomly chosen to be treated with or without meditation therapy. Being in the study lasts about 6 months. Medical tests will be done during the study to learn and track the health of participants. People with be paid for participation. (IRB#: IRB_00133405)
Testing Nectero EAST in Adults with Small to Mid-Sized Abdominal Aortic Aneurysms
An abdominal aortic aneurysm is an enlarged artery or tube in your belly that carries blood from your heart to the rest of the body. When the abdominal aorta enlarges the wall weakens and stretches, eventually can get big and thin enough to burst open, which can bleed and cause death. Nectro EAST is a treatment designed to slow the growth and prevent the bursting of an abdominal aortic aneurysm and may decrease the need for surgery in the future. People in the study will be required to come in for in-person clinic visits and be followed for 5 years to monitor the growth of the aneurysm. People randomly chosen to be treated with Nectro EAST will undergo a one-time 1-hour surgery. The surgery is performed through the groin and uses a balloon to deliver medication directly to the aneurysm. The balloon is removed after and recovery is very minimal. Being in the study for both groups lasts 5 years and medical tests will be done to track the health of participants. (IRB#: IRB_00170182)
Testing Ovaprene® as a Method of Birth Control
The study device, Ovaprene, is a possible new method of birth control. The study will test the device to see if it will help people and is safe. Participants assigned female at birth will use the device. Standard-of-care counseling will be provided before using the device. Participants will record study activity in an electronic diary. Participation requires attending in-person visits at the study clinic. Full participation lasts about 15 months. Medical tests will be done to track the health of participants. (IRB#: IRB_00170641)
Testing Spesolimab for Adults with Hidradenitis Suppurativa
Hidradenitis Suppurativa is a skin condition that causes painful lumps and soars on parts of the body such as the armpit. This study will test a drug called Spesolimab to treat adults with this disease. The study wants to see if the drug will help people with this disease and is safe. People in this study will be randomly chosen to be treated with Spesolimab or a placebo for 16 weeks. The study drug and placebo are taken as infusions (a liquid drug given under the skin) for 4 weeks at the beginning of participation. Then the drug is given as an injection (liquid drug given instantly into the skin) for the remainder of the study. After 16 weeks all participants will be given the study drug. Being in this study requires 31 study visits at the clinic for a little over a year. Medical tests will be done during the study to track the health of participants. (IRB#: IRB_00167413)
Testing SSDXP-13 a Study Drug for People with Congenital Sucrase-Isomaltase Deficiency
Congenital Sucrase-Isomaltase Deficiency CSID is a genetic condition that can affect a person's ability to digest sugars, such as sucrose (a naturally occurring sugar found in fruits and known as table sugar) and maltose (the sugar found in grains). This study will test the study drug SSDXP-13 for people who have CSID. The study wants to see if the drug will help people with this disease and is safe. The study is for parents and their children. Children ages 6 months to 17 years old will take the study drug as a mixture added to water or milk. Being in the study requires completing surveys on the cell phone during the treatment. People in the study will attend both in-person visits at the study clinic and some visits can be over the phone or telehealth on a device such as a computer. Medical tests will be done during the study to learn and track the health of participants. (IRB#: IRB_00165049)
Testing the Abbott Deep Brain Stimulation Outcomes Over Time
This study is testing an approved device called the Abbott Deep Brain Stimulation (DBS) system. The device is an implant that helps treat a persons movement disorder. The study is testing to see the long-term safety and effectiveness of the device. The participant's doctor will need to recommend the treatment. People in the study will attend in-person visits that are part of the standard of care with the Neurologist. Participants will complete surveys to collect information about the safety and effectiveness of the treatment over time. Being in the study lasts 5 years. (IRB#: IRB_00128661)
Testing the Device XEN Glaucoma Treatment System for People with Glaucoma
Glaucoma is high pressure inside the eye that can lead to blindness. This study will test a device XEN Glaucoma Treatment System to treat people with this disease. The study wants to see if the device will help people with this disease and is safe. People in the study will attend pre-study treatment, surgery, and post-surgery treatment. Being in the study requires at least 11 study visits at the clinic for about 14 months. Medical tests will be done during the study to track the health of participants. (IRB#: IRB_00157451)
Testing the Drug Baricitinib in Patients Ages 6 to 18 Years Old with Alopecia Areata
Alopecia Areata is sudden hair loss that often occurs in the hair on a persons head. This study will test a drug called Baricitinib to treat patients ages 6 to 18 years old with this disease. The drug has already been approved for adults with this condition. The study wants to see if the drug will help the specific age of patients with this disease. Participants will be treated with Baricitinib. The drug is taken as a liquid or a swallowed pill. Being in the study requires up to 18 study visits at the clinic over 2.5 years. Medical tests will be done during the study to track the health of participants. (IRB#: IRB_00166438)
Testing the Drug Dapansutrile for Adults with Gout Flare
Gout arthritis occurs in a persons joints causing flaring (swelling and severe pain). This study will test a drug called dapansutrile to treat adults with this condition. The study wants to see if the drug will help people with the disease and is safe. People in the study will be randomly chosen to be treated with dapansutrile or a placebo. A placebo looks like the study drug but does not have the medication. Being in the study requires at least 4 study visits at the clinic for about 36 days and 1 follow-up phone call. During the treatment period, participants will be contacted every 24 to 48 hours via telephone or text messaging. Medical tests will be done during the study to track the health of participants. (IRB#: IRB_00167679)
Testing the Drug DYNE-251 for People with Duchenne Muscular Dystrophy
Duchenne Muscular Dystrophy is a disease that prevents muscles in the body from being protected from stress and damage. This can cause falling, making it hard to get up and run. This study will test the drug DYNE-251 for people with this disease. The study wants to see if the drug will help people with this disease and is safe. People in the study will be randomly chosen to be treated with the study drug DYNE-251 or a placebo. A placebo looks like the drug but without the medication. Being in the study requires up to 42 study visits for about 35 months. The visits will be in person at a study clinic. Medical tests will be done to track the health of participants. (IRB#: IRB_00151486)
Testing the Drug Finerenone for Chronic Kidney Disease and Proteinuria
Chronic Kidney Disease is when kidneys are damaged and cannot filter blood in the body. This can cause hypertension (high blood pressure), increase the body's release of urinary protein (proteinuria), and decline in renal (kidney) function. This study will test a drug called BAY 94-8862 (finerenone) to treat Chronic Kidney Disease and proteinuria. The study wants to see if the drug will help people with this is safe. People in this study will be randomly chosen to be treated with finerenone or a placebo. The drug and placebo are taken as a swallowed pill or liquid. A placebo looks like a drug but does not have the medication. Being in the study requires up to 10 study visits over 10 months. Study visits are held in person at the study clinic or a combination of in-person and using a video call or phone call. Medical tests will be done during the study to track the health of participants. (IRB#: IRB_00169672)
Testing the drug Fluticasone Propionate in adults with eosinophilic esophagitis
Eosinophilic esophagitis is a disease that affects the lining of the tube between your mouth and stomach. This study will test a drug called fluticasone propionate to treat adults with this disease. The study wants to see if the drug will help people with the disease and is safe. People in this study will be randomly chosen to be treated with fluticasone propionate or a placebo. The drug and placebo are taken as a swallowed pill. Later in the study, people on the placebo can be switched to the drug. Being in this study requires up to 15 study visits at the clinic over 48 weeks. Medical tests will be done during the study to track the health of participants. (IRB#: IRB_00165383)
Testing the Drug HM15211 for People with Nonalcoholic Steatohepatitis
Nonalcoholic Steatohepatitis (NASH) is swelling of the liver due to the buildup of fat in the liver cells of people who drink little or no alcohol. If swelling of the liver lasts it can lead to scarring (fibrosis) and serious medical issues. The study will test a drug called HM15211 to treat people with this condition. The study wants to see if the drug will help people with the condition and is safe. People in the study will be randomly assigned to one of four groups. Three of the groups will be treated with a different dose of the drug and one group will receive a placebo. The placebo looks like the study drug but does not have the medication. Being in the study requires up to 21 visits at the study clinic for about 65 weeks. People will write in a journal and complete other medical tests to track their health. (IRB#: IRB_00136282)
Testing the Drug INBRX-101 in Adults with AATD Emphysema
AADT emphysema is a disorder where too much air collects deep in the lungs that is caused by the lack of a protein called alpha-1 antitrypsin (AAT) in the body. A deficiency of AAT (AATD) can damage the lungs and liver if not treated. The study will test a drug called INBRX-101 to treat adults with this disease. The study wants to see if the drug will help people with the disease and is safe. People in this study will be placed into two groups. Group 1 will receive INBRX-101. Group 2 will receive Zemaira. Being in the study requires attendance at the study center for up to 51 weeks once a week to receive treatment with either INBRX-101 or Zemaira. Other study visits will be required for medical tests to track the health of participants. (IRB#: IRB_00169660)
Testing the Drug Lorundrostat in Adults with Uncontrolled Hypertension
Uncontrolled Hypertension is when the blood flow in the body is too high against the arteries and is unable to be controlled. This study will test a drug called Lorundrostat or MLS-101 to treat adults with this condition. The study wants to see if the drug will help people with the health condition. People in this study will be randomly chosen to be treated into three different groups. One group will receive the same daily amount of Lorundrostat or MLS-10. Another group will receive the same daily amount and then increase the daily amount. While a different group receives a placebo. A placebo does not have the treatment. The drug and placebo are taken as a swallowed pill. Being in the study lasts up to 5 months with a total of 9 clinic visits. Participants will be paid $50.00 per visit. Medical tests are done to track the health of participants. (IRB#: IRB_00165346)
Testing the Drug mRNA-1345 to Protect Infants from RSV
RSV is a virus that infects the lungs and respiratory tract - the parts of the body related to breathing. It can cause a runny nose, sore throat, cough, and fever. RSV can lead to serious respiratory tract problems like pneumonia and bronchiolitis. Infants under 6 months of age are at the greatest risk of having severe RSV. This study will test whether vaccinating pregnant women with a study drug called mRNA-1345 helps prevent RSV disease in their babies. People who are pregnant in the study will be randomly chosen to be treated with mRNA-1345 or a placebo. A placebo looks like the study drug but does not have the active drug. Participation in the study lasts about 15 months. Medical tests will be done during the study to track the health of participants. (IRB#: IRB_00169145)
Testing the Drug Nintedanib for Adults with Myositis Interstitial Lung Disease
Myositis interstitial lung disease is a disorder that results in the thickening, stiffness, and scarring of the tissues of the lung which makes breathing difficult. This study will test Nintedanib on adults with this disease. The study wants to see if the drug will help people with this disease and is safe. People in the study will be randomly chosen to be treated with the study drug Nintedanib or a placebo. A placebo looks like the drug but without the medication. Being in the study requires up to 11 study visits for about 52 weeks. The visits will be in person at a study clinic or lab and at home. Medical tests will be done to track the health of participants. (IRB#: IRB_00170784)
Testing the Drug Ozanimod in adults with Ulcerative Colitis (UC)
Ulcerative colitis (UC) is a disease that inflames a persons digestive system (how food is processed in the body) causing health problems such as stomach pain, fever, and even an increased risk of colon cancer. This study will test a drug called ozanimod to treat adults with this disease. The study wants to see if the drug will help people with the disease and is safe. People in this study will be placed into two groups based on their medication use. Group 1 will be people who have used standard UC medication. Group 2 will be people who have used advanced UC medication. Being in the study requires 2.4 years and about 8 visits to the study center. Each visit may vary from 2-7 hours depending on what needs to occur at each visit. Medical tests will be done during the study to track the health of participants. (IRB#: IRB_00164781)
Testing the Drug Psilocybin in Adults with Treatment-Resistant Depression
Treatment-resistant depression (TRD) is when a person receives help for depression such as therapy with a physiatrist and taking an anti-depression drug, but depression keeps coming back. This study will test a drug called Psilocybin, to treat patients with this condition. The study wants to see if the drug will better help people with this disease and is safe. People in this study will be randomly chosen to receive psilocybin or a placebo. The drug and placebo are taken as a swallowed pill. The placebo is a pill without the treatment. Being in the study requires participation for 55 to 62 weeks. Participants will attend clinic visits in person at a University of Utah clinic. Medical tests will be done during the study to track the health of participants. (IRB#: IRB_00159931)
Testing the Drug PTC923 (Sepiapterin) in People with Phenylketonuria
Phenylketonuria (also called PKU) is a condition in which your body can't break down an amino acid called phenylalanine. This study will test a drug called PTC923 (Sepiapterin) to treat people with Phenylketonuria. The study wants to understand the long-term safety in patients with PKU and changes in diet. People in this study will be placed into two groups depending on their blood phe levels to be treated with PTC923 (Sepiapterin). The drug is taken as a swallowed pill. Being in the study may require about 15 visits at the study clinic and some may be virtual visits on the phone. This is determined by participants' assigned groups. Medical tests will be done during the study to track the health of participants. (IRB#: IRB_00150586)
Testing the Drug RE104 to Treat Postpartum Depression
Postpartum depression can occur after a woman has childbirth. This study will test a drug called RE104 to treat women with this condition. The study wants to see if the drug will help people with the condition and is safe. Participants in the study will be randomly chosen to be treated with a low or high dose of RE104. The drug will be given one time under the skin of the upper arm. Being in the study requires a total of about 10 to 11 study visits in person at the study clinic with some of the visits over the phone. Participation lasts about 53 days. Medical tests will be done during the study to track the health of participants. (IRB#: IRB_00176449)
Testing the Drug Ubrogepant in Adults and Young Adults with Migraine
Migraine is a reoccurring headache that varies in pain and can cause other health issues such as sick to the stomach, and sensitivity to light and sound. The study will test a drug called Ubrogepant to treat people with the disease. The study wants to see if the drug will help people with the disease and is safe. People in this study will be randomly treated with the Ubrogepant or a placebo. The drug and placebo are swallowed as a pill. This placebo does not have the treatment. Participation in the study is about 6-7 months. Medical tests will be done in-person, on the phone, and online such as using a computer during the study to track the health of participants. (IRB#: IRB_00149183)
Testing the Drug VE202 in Adults with Mild-to-Moderate Ulcerative Colitis
Mild-to-Moderate Ulcerative Colitis (UC) causes inflammation of the large intestine (colon). This study will test a drug called VE202 to treat adults with this disease. The study wants to see if the drug will help people with the disease and is safe. People in this study will be randomly chosen to be treated with the study drug VE202 or a placebo. The drug and placebo are taken as a swallowed pill. The placebo does not have the treatment. Later in the study, people on the placebo are switched to the drug, and people on the drug are switched to the placebo. Participation in the study requires up to 2.5 years. Medical tests will be done during the study to track the health of participants. (IRB#: IRB_00168499)
Testing the drug XEN1101 in adults with epilepsy
This study will test a new study drug called XEN1101 to help patients with epilepsy. Epilepsy is a disease that may occur due to a genetic disorder or brain injury. This condition affects the nerves in the brain causing seizures. The study wants to see if XEN110 will help people with the disease and is safe. People in this study will all receive XEN1101 once a day. The drug is taken as a swallowed pill. Being in the study requires regular clinic visits for about 8 months during participation. Medical tests will be done during the study to track the health of participants. (IRB#: IRB_00164793)
Testing the Study Drug ACP-101 for People with Prader-Willi syndrome
Prader-Willi syndrome (PWS) is caused by a defective gene in a persons body. This causes hyperphagia (extreme hunger) and behavioral symptoms (such as obsessive-compulsive symptoms). This study will test the study drug ACP-101 to treat people with PWS. This study wants to see if the medication will help people and is safe. People in the study will be randomly chosen to be treated with the study drug ACP-101 or a placebo. A placebo looks like the study drug but does not have the medication. The study drug is taken as a nasal (nose) spray. Being in the study requires attending in-person visits at the study clinic. Study participation lasts about 16 weeks. Medical tests will be done during the study to track the health of participants. (IRB#: IRB_00171100)
Testing the Study Drug Barzolvolimab (CDX-0159) in Adults with Active Eosinophilic Esophagitis
Eosinophilic esophagitis is a disease that affects the lining of the tube between your mouth and stomach. This study will test a drug called Barzolvolimab (CDX-0159) in adults with this disease. The study wants to see if the drug will help people with the disease and is safe. People in this study will be randomly chosen to be treated with doses of Barzolvolimab (CDX-0159) and placebo. The drug and placebo are taken as a swallowed pill. A placebo is a pill that does not have the drug. Being in the study requires up to 50 weeks at the clinic. Medical tests will be done during the study to track the health of participants. (IRB#: IRB_00170529)
Testing the Study Drug BHV-7000 for People with Focal Epilepsy
Focal Epilepsy is a partial seizure caused by a specific area of the brain and affects one side of the body. This study will test a drug called BHV-7000 for people with this condition who are taking anti-seizure medications but still have seizures. The study wants to see if the study drug will help people and is safe. People in this study will be randomly chosen to be treated with BHV-7000 or a placebo. The placebo looks like the study drug but does not have the treatment. People in the study will continue to take the current dose of the anti-seizure medication while taking BHV-7000 or the placebo. Participants in the study will track seizures in an electronic diary and record when the study drug is taken, and any other medications. Being in the study requires attending in-person visits at the study clinic. Participation lasts about 20 to 22 weeks. Medical tests will be done to track the health of participants. (IRB#: IRB_00176113)
Testing the Study Drug BLU-5937 for Adults with Refractory Chronic Cough (RRC) Including Unexplained Cough
Refractory Chronic Cough (RCC) is a cough lasting more than 8 weeks that has not improved after treatment for possible causes (such as acid reflux, asthma, or nasal congestion). An unexplained cough is a cough lasting more than 8 weeks that does not have a known cause, even after a thorough medical evaluation and testing. This study will test a drug called BLU-5937 in adults with these conditions. The study wants to see if the drug will help people with RCC or unexplained cough and is safe. People in this study will be randomly chosen to be treated with doses of BLU-5937 and placebo. The drug and placebo are taken as a swallowed pill. A placebo is a pill that does not have the study drug. Participation in the study will last up to 1.5 years. The study will consist of a 4-week screening period, a 79-week study drug treatment period, and a 2-week follow-up period. Participants will be asked to attend up to 19 visits at the study center to complete the study assessments and procedures. Participants will also have 6 phone calls from the study team, to check on participants health. Study procedures include a chest x-ray or CT scan, physical exams, blood tests, breathing tests, questionnaires, wearing a cough monitor, and taking the study drug. Participants will be compensated at time points throughout the study. (IRB#: IRB_00160784)
Testing the Study Drug Crovalimab in People with Atypical Hemolytic Uremic Syndrome
This study will test a new treatment called Crovalimab to treat people with Atypical Hemolytic Uremic Syndrome (aHUS). aHUS is a rare disease that causes tiny blood clots to form in the small blood vessels of the body. This condition can lead to organ damage and failure in the body such as kidneys. The study wants to see if Crovalimab will help people with this disease and is safe. People in this study will be placed in one of three groups; people who have not been treated with Crovalimab, people who are changing their current treatment from Eculizumab or Ravulizumab to Crovalimab, or people who received Eculizumab or Ravulizumab in the past, the treatment stopped, and now a doctor decided to restart the treatment. The amount of Crovalimab a person receives depends upon the weight of the participant. Crovalimab is given as a liquid into the participants vein and given under the skin. Study participation may be up to 7 years and requires attending in-person at study clinics. Medical tests will be done during the study to track the health of participants. (IRB#: IRB_00161592)
Testing the Study Drug Etelcalcetide for People with Secondary Hyperparathyroidism Receiving Hemodialysis
Secondary Hyperparathyroidism (HPT) is associated with loss of calcium from the bones, which can lead to bone pain and fractures, and problems with blood and heart vessels. Etelcalcetide is a study drug for people with this disease. The study will test the drug Etelcalcetide to see if it will help adults with the disease and is safe. People in the study will be randomly chosen to receive the study drug Etelcalcetide or a placebo. The placebo looks Etelcalcetide but does not have the medication. Being in the study requires attending in-person visits at the study clinic for about 32 weeks. Medical tests will be done to track the health of participants. (IRB#: IRB_00116991)
Testing the Study Drug Oral Paricalcitol in Infants and Children with Chronic Kidney Disease Peritoneal Dialysis of Hemodialysis
Chronic Kidney Disease Peritoneal Dialysis of Hemodialysis is a disease that can lead to kidney failure and is treated by giving fluid into the body to clean the blood. This study will test a drug called Oral Paricalcitol to treat infants and children ages 0 to 9 years old with stage 5 (patients with an average of 5 to 10 years left of life). The study drug has been approved for patients ages 10 to 16 years old. The study wants to see if the drug will help infants and children ages 0 to 9 years old with this disease and is safe. Patients in the study will be treated with Oral Paricalcitol. The drug is taken as a swallowed liquid. There are 3 ways to participate in the study. These include in-person study visits at the clinic, at home with a nurse, or over Zoom (a virtual way to attend a visit on a technology device such as a computer) with help from a nurse. Participation is about 43 weeks. Medical tests will be done to track the health of participants. (IRB#: IRB_00141843)
Testing the Study Drug Ritlecitinib for People with Vitiligo
Vitiligo causes the loss of skin color and blotches of the skin. This study will test a drug called Ritlecitinib for people with this condition. The study wants to see if it will help people and is safe. People in the study will be randomly chosen to receive Ritlecitinib or a placebo. A placebo looks like the drug but does not have the medication. Being in the study requires attending in-person visits at the study clinic and lasts about 2 years. Medical tests will be done to track the health of participants. (IRB#: IRB_00171778)
Testing the Study Drug TN-201 in Adults with Symptomatic MYBPC3 Mutation-Associated Hypertrophic Cardiomyopathy
Symptomatic MYBPC3 (a gene found in the muscle of the heart) mutation-associated non-obstructive hypertrophic cardiomyopathy is one of the most common inherited cardiac (heart) diseases. This study will test a drug called TN-201 to treat adults with this disease. The study wants to see if the drug will help people with this disease and is safe. The study will have 2 groups of people receiving different doses of the study drug. All participants will receive the study drug. The drug is given as an infusion (liquid drug given under the skin). Being in the study requires meeting in person at a study clinic at different periods of time over 5 years. Participants will receive payment for participation. Medical tests will be done to track the health of participants. (IRB#: IRB_00166206)
Testing the Study Drug Tolvaptan for Children with Autosomal Recessive Polycystic Kidney Disease
Autosomal Recessive Polycystic Kidney Disease is a rare kidney disease that causes poor kidney function in children. This study will test a drug called Tolvaptan to treat children with this disease. The study wants to see if the drug helps children with this disease and is safe. Children in the study will participate in at least 11 in-person study visits at the clinic and 14 more visits have the option of home health visits. Participation lasts about 25 months. Medical tests will be done during the study to track the health of participants. (IRB#: IRB_00150059)
Testing the Timing of Tics Over Time in Children with Persistent Tic Disorders, Including Tourette Syndrome
This is a study is to learn the timing of tics over time in children with Persistent tic disorders, including Tourette syndrome. These conditions are brain disorders that cause uncontrolled body movements and sounds. This behavior may improve and worsen depending on what happens to a person throughout a lifetime. Being in the study requires a child and their parent to attend 6 private video visits using a computer with internet. Visits will include interviews, surveys, learning activities, and training. Participation in the study lasts about 7 hours. All visits will be video recorded and kept in a secure place. (IRB#: IRB_00171031)
Testing the Treatment of Donor Cell Transplants for Children and Young Adults with Severe Myeloid Leukemia
This study is testing the treatment with Natural Killer cells from a donor to a patient, which may lower the chance that a blood disease severe myeloid leukemia will come back after a haploidentical (half-matched) transplant (moving cells from a donor to a patient). The study wants to see if the treatment will help people with severe myeloid leukemia. People in the study will receive Natural Killer cells from a central line placed in the body, most likely the chest. A central line is a tube that allows medications, medical tests, and transfusions to occur. Transfusion is a way to move blood from a donor to a patient. Being in the study requires attending in-person study visits at a clinic for about 2 years. Medical tests will be done to track the health of participants. (IRB#: IRB_00152764)
Testing the Use of Ultrasound Waves for Adults with Chronic Pain
An ultrasound is a device used on the outside of a persons body that creates sound waves (vibrations) to see the inside organs. This study tests the use of ultrasound to send waves in a focused area as a low-risk method to help people with chronic pain. This study wants to see if the low-risk method is as effective as a different method. People in the study will complete surveys and participate in an MRI (a device used to create an image of the area studied). Being in the study requires at least 4 study visits at the clinic. Medical tests will be done during the study to track the health of participants. (IRB#: IRB_00175546)
Tezepelumab: A Study Drug for Patients with Eosinophilic Esophagitis (EoE)
Eosinophilic Esophagitis (EoE) is a disease that may cause vomiting and heartburn and make swallowing difficult. Tezepelumab is a study drug for patients with EoE. Research is needed to learn if Tezepelumab is safe and effective at helping people with EoE. We also hope to better understand EoE and health problems related to the disease. The information we gain may aid future patients. (IRB#: IRB_00162145)
The Attention of Expert Boxers
Making instant decisions is important in a variety of settings, including sports such as boxing. When time is limited, decision-making success is strongly determined by things that influence immediate attention. Research is needed to learn whether expert boxers show better attention skills compared to untrained persons. The information we learn may aid future patients. (IRB#: IRB_00155440)
The Relationship of Port Wine Stains and Melanoma
Port-wine stains (PWS) are a common, benign (non-cancerous) birthmark caused by defects in blood vessels in the skin. PWS are made up of not well-developed capillaries (small blood vessels). This enlarges the vessels and causes a reddish area on the skin. The study wants to see if there is a common cause explaining the possible relationship between Port Wine Stains at birth and melanoma (a serious type of skin cancer) later in life. People in the study will have two small biopsies taken from the skin. This means a tool will take a small sample of skin tissue. Participants will have a biopsy of the port wine stain, and one biopsy of normal skin (no PWS or discoloration present). Participants will also give a saliva sample (spit in a tube). Photographs will be taken of the PWS. Being in the study requires attending a one-time in-person visit at the study clinic. The visit lasts about 20 minutes. (IRB#: IRB_00152848)
The SPRINT® System a Nerve Stimulator for People with Head Pain
The SPRINT® system can block nerves that send pain signals to the brain. Research is needed to learn how safe the SPRINT® system stimulator is and how well it helps people with head pain. The information we gain may aid future patients. (IRB#: IRB_00159617)
The Use of Blood Thinners after a Cesarean Delivery
This study aims to better understand the use or non-use of blood thinners 10 days after a person has a cesarean delivery (the baby is delivered through a cut made in the stomach of the person giving birth). This study wants to better learn if the treatment helps prevent blood clots and is safe. Participants will have recently had a cesarean delivery at the University of Utah hospital. Participants will be asked if they would like to answer a few short follow-up questions. The questions will help learn if any complications have occurred since the delivery. If participants agree they will receive an online survey that will take about 5 minutes or less. If a complication did occur the study team will reach out to the participant via phone call or email for additional details. (IRB#: IRB_00177040)
Thermal Comfort in Severe Environments Using Virtual Reality
The thermal (temperature) of an environment where people work and learn can impact peoples comfort levels. Some people have limited ability to change their thermal environment in severe conditions such as disasters. This study wants to learn the thermal comfort and reactions in such settings. People in the study will wear a virtual reality (VR) device worn around the head and over the eyes that show different cold environments as experiences to see how it impacts a persons thermal comfort levels. Being in the study requires attending in person for 1 to 3 visits lasting about 1 to 2 hours each. Participants will be paid for their time in the study. (IRB#: IRB_00154093)
Thigh Muscle Changes Following Knee Injury and Surgery
The purpose of this study is to learn more about muscle function after joint injury of the knee. Including the characteristics of muscle changes and whether it is related to how the muscle functions (strength). The information may improve health care and quality of life for people following knee injuries. People will have medical procedures done to see an image of the leg and strength of the leg and have a biopsy (taking a small sample of tissue out of the muscle). Healthy people will attend in person at the study clinic for about 3 hours. People planning to have surgery for the medical condition will attend 3 study visits for a total of about 4-6 hours over 4 months. People will be paid for participation. (IRB#: IRB_00165256)
Timing of Exercise on Diabetes and Sleep
Older adults who have overweight or obesity, low physical activity, and poor sleep may be at a higher risk for developing diabetes. Research is needed to learn if exercise in the morning or afternoon/evening is better at reducing the risk of diabetes and improving sleep. The information we gain may aid in the prevention and treatment of diabetes for future patients. (IRB#: IRB_00156659)
Tobacco and Alcohol Use Among People with Low Income
The study wants to learn the reason people engage in certain behaviors. The study team wants to know how certain factors such as emotions, and social and psychological factors on discrimination impact the use of tobacco and alcohol among people who are low income. Being in the study will last about 9 years requiring 2 visits from the participants home. One online virtual visit at the beginning of the study and one phone call at the end of the study. Participation also requires downloading an application on the participants cellphone and answering up to 8 short phone surveys on the smartphone per day for 7 days in a row. The surveys will ask the participant about feelings, experiences, emotions, smoking, and drinking behaviors. (IRB#: IRB_00170612)
TRADIPITANT: A Study Drug to Help People with Gastroparesis
Tradipitant is a study drug to help people with symptoms of gastroparesis, a stomach disease. Research is needed for us to know the effects of the study drug. The information we learn will help us understand if it can improve the health of people with gastroparesis. (IRB#: IRB_00129133)
Transcranial Magnetic Stimulation (TMS) for People with Depression in Multiple Sclerosis (MS)
Multiple sclerosis (MS) is a disease that damages nerve cells in the brain and spinal cord. This can affect a persons physical and mental health. Depression, or major depressive disorder, is common in people with MS and often has a serious impact on quality of life. Depression can be difficult to treat with medications in MS. Transcranial magnetic stimulation (TMS) is a safe and approved treatment for medication in people with depression. Little is known about TMS for people with MS. This study wants to better understand the safety and effectiveness of TMS treatment for depression in MS. Participants will receive standard outpatient TMS treatment for depression. This includes in-person, phone, and online Zoom visits to complete surveys and track the health of participants. (IRB#: IRB_00164631)
Treating healthcare provider burnout using Psilocybin-Assisted Psychotherapy and Mindfulness-Based Stress Reduction
Many healthcare providers on the frontlines of the SARS-CoV-2 pandemic felt burnt out and depressed. We want to see if mindfulness training helps with these feelings. We also want to see if psilocybin-assisted therapy helps with these feelings. The frontline healthcare providers who sign up will get mindfulness training for 8 weeks. Half of the providers will also get psilocybin-assisted therapy. (IRB#: IRB_00152312)
Treating Obstructive Sleep Apnea with the Aura6000® System
The aura6000® system is a device that helps open the airway while a person sleeps to prevent obstructive sleep apnea (OSA). Research is needed to see if it is safe and effective to reduce OSA. This information will help determine if this device may be used to improve the care and quality of life for people with OSA. (IRB#: IRB_00150772)
Treating Pregnant People with Depression during Pregnancy
Depression is a very common and serious medical condition during pregnancy. This study wants to explore a mental health treatment called Cognitive Behavioral Therapy- Rumination Focused (CBT-RF) as an option for pregnant people who are already receiving an approved treatment called Transcranial Magnetic Stimulation treatment (TMS) for depression. TMS stimulates the brain using a non-harmful electrical current when wearing a type of cap on top of a persons head. People in the study will be interviewed, answer surveys, meet with a licensed therapist, participate in therapy for CBT-RF, and participate in fMRI scans. An fMRI is like a large, spinning magnet machine that rapidly creates pictures of the brain. Being in the study requires up to 10 visits to the clinic for about 6 weeks. Medical tests will be done during the study to track the health of participants. Participants will be paid for being in the study. (IRB#: IRB_00166560)
Trial of Parkinson's and Zoledronic Acid
This home-based study is a randomized (1:1) placebo-controlled trial of a single infusion of zoledronic acid-5 mg (ZA) for the prevention of fractures in men and women aged 60 years and older with Parkinson's disease and parkinsonism with at least 2 years of follow-up. A total of 3500 participants will be enrolled and randomized in the United States. Participants, follow-up outcome assessors, and study investigators will be blinded to assigned study treatment. This trial is funded by the National Institute of Aging. (IRB#: IRB_00170689)
U-STEP: A Health App for People with Peripheral Vascular Disease
The vascular system is made up of vessels that carry blood in the body and lymph (fluid in the body that carries white blood cells to fight infection). Vascular surgery is a way to help people with arterial diseases (narrowing of the blood vessels that reduce blood flow) and venous diseases (veins in the legs do not move enough blood back toward the heart). Such as peripheral vascular disease (PVD) a circulation (how the blood flows through the body) disease. The purpose of the surgery is to improve a persons quality of life, pain, and ability to function. The goal of our research is to see if using a smartphone app helps vascular surgeons and patients track their overall health. The information we gain may aid future patients. (IRB#: IRB_00162534)
Ultrasound Brain Simulation to Treat People with Post-Traumatic Stress Disorder
This study is testing a new method of brain stimulation (a small amount of electricity given through a persons head) to improve Post Traumatic Stress Disorder (PTSD). PTSD is a condition that can affect the brain caused when a person has gone through a shocking, scary, or dangerous life event. Recent new technology makes it possible to provide safer and better ways for brain therapy. The study wants to see if ultrasound (a way to see inside of a persons body) brain therapy will help people with PTSD. Being in this study requires up to 5-6 in-person study visits at a clinic over about 1 to 2 months. This includes completing surveys, interviews, a physical exam, ultrasound, and MRI scans (ways to see the inside of a persons body). Medical tests will be done during the study to track the health of participants. People will be paid for their time in the study. (IRB#: IRB_00173062)
Ultraviolet Ray Prevention for Children
Melanoma is the 6th most common type of skin cancer in the United States. The just-in-time intervention (JITAI) application (app) is a tool used on a cell phone. The tool can help children and adults know how much time in ultraviolet rays (UVL) from the sun. Research is needed to learn what children and adults think about using the JITAI app. We hope to reduce the time children spend in UVR, so sunburns occur less. (IRB#: IRB_00121617)
Understanding how to prevent regaining weight after weight loss for adults who are overweight
We are doing interviews with generally healthy adults who are overweight now or have been in the past. The interviews will be 30 minutes long and ask many questions. Some of the questions will be about things that may cause a person to regain weight they had lost, and how to get additional help from a professional to support weight loss. The interview can be done in-person or on Zoom. People in this study will also need to have their height and weight measured at the University of Utah. (IRB#: IRB_00166611)
University of Utah Long Covid Registry
COVID-19 Study
Researchers at the University of Utah have established a registry to follow individuals who are experiencing prolonged symptoms after COVID-19 infection. We are interested in following people with "Long Covid" using in depth health surveys and optional blood draws to better understand this condition with the goal of ultimately developing clinical management strategies. (IRB#: IRB_00140978)
Utah Childrens Project: A Study Before Pregnancy
Environment and genetics can impact the health of families for generations. We want to learn more about how exposures to the environment affect the health and development of children before pregnancy. Research is needed to understand how various physical, chemical, biological, social, behavioral, and natural environments may relate to childhood diseases. The information we gain may lead to better health for future generations. (IRB#: IRB_00063183)
Vaccinations for People with Influenza (flu)
The Influenza (flu) vaccination is the most effective method of preventing the flu and other health-related issues. There are many types of flu vaccines. One type is a newer flu vaccine called a recombinant (new gene combination) and another is a standard egg-based flu vaccine. We want to know which Food and Drug Administration (FDA) approved vaccine works best. The information we gain may aid future patients. (IRB#: IRB_00157020)
Vanpools for Frontline Healthcare Workers
Sick of the stress of commuting? Done with traffic? Then join the Vanpool Trial at the U! We are looking for participants who want to change how they commute to UHealth. Anyone who commutes to a UHealth location is eligible to participate. We are testing Vanpools, in partnership with UTA and UCAIR, to understand how it impacts employee commute stress, quality of life, and your views of public transit and climate change. Vanpools are shared commute vans that a group of people use to get to and from a neighborhood to work. Eligible participants will be randomized to either a vanpool or a educational intervention, so you must be willing to join a vanpool for up to 5 months. Contact us today to learn how you can join! (IRB#: IRB_00166630)
Viewing Events
The purpose of this study is to determine what people remember from experiences they have in Virtual Reality. We will ask you demographic questions and about your experience with VR. You will view a fictional park scenario presented through a virtual reality (VR) headset, and we will measure where you look and your physiological responses (e.g., heart rate, perspiration) using non-invasive wearable technology. Then we will ask you about the video. Participation in the study requires one study visit and should last up to an hour. Participants will be compensated for their time. (IRB#: IRB_00170628)
Virtual Reality and Mindfulness Therapy for People with Opioid Use Disorder
Virtual reality is a technology device used to create an unreal environment for people to face situations such as Opioid (drug) Use Disorder (OUD). A therapy called Mindfulness-Oriented Recovery Enhancement (MORE) has been shown to help people with chronic pain and other issues of OUD. Research is needed to learn if VR with MORE is just as well as MORE without VR. We hope to apply what we learn to better help people using Telehealth (doctor visits received outside of doctors offices such as on a computer). The information we gain may aid future patients. (IRB#: IRB_00157860)
Virtual Reality Experience to Increase Empathy and Awareness of the Social Determinants of Health in Nursing Students
This study will help see how well an immersive virtual reality (VR) experience (a 3-D eyewear device that allows experiences not real to feel real) works and impacts the nursing experience for the awareness and empathy of social determinants of health (SDOH). SDOH can be where a person is born, lives, works, and other activities in society. If effective, the VR experience will be used to develop educational programs to teach future nursing students and clinicians about SDOH. People in the study will complete surveys and participate in a VR experience. People will also participate in interviews and group discussions. There will be future follow-up contact through email or phone. Participants will receive $75 for participation. (IRB#: IRB_00178601)
Voice Exercise Program
A vocal cord produces a persons voice. Research is needed to better know how a vocal cord works. We want to see if a voice exercise program improves a person's pitch range. This is how high or low a persons voice can sound. The information we gain may aid future patients. (IRB#: IRB_00162035)
Volixibat: A Possible Rare Liver Disease Medication
PBC is a chronic rare liver disease. Volixibat is a potential medication for symptoms of this disease. Scientists and doctors do not know the safety and effectiveness of this drug. Research is needed to learn if it may be approved by the United States Food and Drug Administration (FDA) and then used to improve the health of PBC patients. (IRB#: IRB_00148152)
VRDN-001: A Study Drug for People with Thyroid Eye Disease
VRDN-001 is a study drug for people with thyroid eye disease. Research is needed to learn the safety and effectiveness of the study drug. The information we gain may aid future patients (IRB#: IRB_00152628)
Working In-Person or Online for Team Problem Solving
In the past, research has shown that working in person for team problem-solving provides better results. Currently, people are working more online. Research is needed to learn if working online for team problem-solving can also produce successful results. (IRB#: IRB_00163653)
Working Memory in People with Epilepsy
Epilepsy is a disorder that causes nerves in the brain to be disturbed and seizures (uncontrolled body movement) to occur. This study will test the memory, attention, and speaking of people with this disorder. This study will see how the brain of people with this disorder keeps information in mind, a skill called 'working memory', as well as pays attention. The working memory helps a person plan things or process spoken and written words. The study wants to improve care for people with epilepsy having surgery and other conditions such as stroke. People in the study will participate in simple computer-based games and tasks while recording brain activity. Participation lasts about three to six hours during a hospital stay. People will receive $25 for participation. (IRB#: IRB_00114231)
XEN1101 Drug Study for People with Primary Generalized Tonic-Clonic Seizures
The purpose of this research is to learn more about the drug XEN1101 and see if it can help to reduce the frequency of seizures (the number of seizures in a given period of time) in adults with primary generalized tonic-clonic seizures. The University of Utah anticipates enrolling five patients in this study. (IRB#: IRB_00159508)
XEN1101: A Drug Study for People with Focal-Onset Seizures
The purpose of this research is to learn more about the drug XEN1101 and see if it can help to reduce the frequency of seizures (the number of seizures in a given period of time) in adults with refractory focal epilepsy (epilepsy that cannot be well controlled by seizure medication). (IRB#: IRB_00159379)
ZYN002: A Study for Children and Adolescents with Fragile X Syndrome (FXS)
Fragile X Syndrome (FXS) is when a gene in a persons body stops making protein. This protein is needed for a persons brain development. ZYN002 is a gel put on the skin to help children and adolescents with FXS. Research is needed to learn more about the efficacy and safety of ZYN002. The information we gain may aid future patients. (IRB#: IRB_00146490)