Lumbar Radiofrequency Ablation for People with Low Back Pain
Lumbar radiofrequency ablation (LRFA) is a treatment used to prevent a targeted nerve in the body from sending pain signals to the brain. This study will compare treatments for low back pain. Participants with chronic low back pain will be randomly assigned to a lumbar radiofrequency ablation (LRFA) or another treatment that may improve pain. The study wants to learn how well LRFA works to improve low back pain. Study participation will take about 3 to 4 hours over 12 months. (IRB#: IRB_00181348)
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 Laryngeal Nerve Factor in Vocal Fold Paralysis
A Laryngeal nerve is what helps people swallow, breathe, and have vocal cord movement in the neck. This study wants to learn how the blood vessels of people with a neurological voice disorder compare to people without a voice disorder. A neurological voice disorder is a condition that makes it difficult for a person to speak. People in the study will participate in a Magnetic Resonance Imaging (MRI) scan. The MRI forms an image of the blood vessels of the laryngeal nerve. People will share medical history with the study team. Participation requires about 1 visit to the study clinic. (IRB#: IRB_00097852)
A Medtronic Product Follow-up Registry
This study will collect information into a follow-up registry from people who have used or intend to use a Medtronic Product. The information collected will be to continue Medtronic product safety and effectiveness and understand the range of product usage in clinical environments such as hospitals. This will help guide development and improvement of medical devices and therapies for patients that inform clinical research. People in the study will provide health information. This includes medical records, interviews, phone calls, mail, emails from the participant, family members, and/or doctors or other health providers. Participants will attend all regularly scheduled doctor visits, tell doctors about medical history, and report any health events such as injuries or hospitalizations. There is no registry end date. (IRB#: IRB_00184960)
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 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 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 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)
A Study Using AMT-191 Gene Therapy in Adult Males with Classic Fabry Disease
Fabry disease is a rare genetic condition that keeps the body from breaking down certain fatty materials that build up in cells. This can result in health issues such as pain in the hands and feet and damage to the kidneys, brain, and heart. This study will test a drug called AMT-191, a gene therapy drug. A gene therapy drug is designed to provide the genetic material not functioning correctly in the body. The study wants to see if the drug will help people and is safe. People in the study will be given a single drug dose through a vein. Participation requires attending in-person visits at the study clinic, which can last about two years. Medical tests will be done during the study to track participants' health. (IRB#: IRB_00180825)
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)
Adalimumab Drug Levels of People with Chronic Anterior Uveitis
Chronic anterior uveitis (middle layer of the eye) disease is a condition that causes inflammation (swelling) of the eye. This can lead to pain, redness, and decreased vision. The study wants to see whether blood levels of adalimumab can be used to predict how well the uveitis will respond to adalimumab. People in the study will have already planned to start adalimumab for chronic anterior uveitis. Being in the study lasts 6 months and requires attending 3 visits to the study clinic during planned regular visits with ophthalmology (eye doctor) and sometimes rheumatology (doctor treating diseases that can affect the body's connective tissues, causing pain, swelling, and stiffness). Medical tests will be done to track the health of participants. (IRB#: IRB_00163045)
Advance Care Planning in Dementia
Advanced care planning is important for adults, but maybe even more for people with memory loss. This disease can leave end-of-life decision-making up to the care partner. Often, the care partner does not know how to make the best decisions in the situation. Research is needed to improve and evaluate a website called LEAD Intervention (Life-Planning in Early Alzheimers and Dementia). LEAD is designed to help persons with memory loss have conversations, document, and share their end-of-life decisions with a care partner, extended family, and healthcare providers. (IRB#: IRB_00132042)
AMX0035 for People with Progressive Supranuclear Palsy
Progressive Supranuclear Palsy (PSP) is a nervous system disease that affects nerve cells in the brain and spinal cord (connects the brain to the rest of the body). The disease worsens over time causing loss of muscle control such as slowing body movement and balance. AMX0035 is a study drug for adults with this disease. The study will test the drug AMX0035 to see if it will help adults with the disease and is safe. AMX0035 is a fixed dose combination therapy designed to reduce neuronal death through blockade of key cellular death pathways originating in the endoplasmic reticulum (ER) and mitochondria. This clinical trial is designed to demonstrate that AMX0035 is safe and tolerable, and to assess its effect on disease progression as measured by the Progressive Supranuclear Palsy (PSP) Rating Scale (PSPRS) over a 52-week double-blind phase. The Phase 2b and Phase 3 study portions are planned to feature an identical design: a randomized, double-blind, placebo-controlled phase that is followed by an optional open-label extension (OLE) phase. The phase 3 portion of ORION may be initiated based on results of the phase 2b Interim Analysis and/or the Primary Analysis and the totality of data from the Phase 2b study portion. (IRB#: IRB_00172910)
Antibodies to AAV8 of People with Late-Onset Pompe Disease
Pompe disease occurs when people do not produce enough of a protein called acid alpha-glucosidase (GAA). GAA is needed for complete breakdown of glycogen (a stored form of blood sugar) in a part of the cell called the lysosome. The absence of GAA causes glycogen to build up in the lysosomes, which damages the cells and leads to muscle weakness. The study will see if people with Late-Onset Pompe disease have antibodies to a virus called adeno associated virus (AAV8). This virus is not known to cause any disease or illness in your body. In everyday life, people are exposed to this type of virus. The study will learn more about the number of people with the disease who have antibodies to AAV8 and the antibody level changes over time, and overall health. People in the study will share current and past medications with the study team, how they feel on a day-to-day basis, and any side effects. Medical tests will also be done during the study to track the health of participants. Being in the study requires attending 6 in-home or in person study clinic visits over 4 months. Study participation lasts about 28 months. (IRB#: IRB_00182542)
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 Barriers to Sun Protection for College Students
This study will assess barriers college students might face in obtaining sunscreen. This study wants to see how to best help people use sunscreen. People in the study will complete a short survey. (IRB#: IRB_00180432)
Assessing People with Peripheral Neuropathy
Peripheral Neuropathy is a disorder of the longest nerves in the body. The disorder results in symptoms of numbness, tingling, and sometimes pain that begins at the toes and may spread up the legs. This can last over months or years, causing problems with balance. The study will assess people diagnosed with neuropathy or those at risk of neuropathy for signs, symptoms, and severity of peripheral neuropathy. People in the study will complete surveys and various medical tests such as physical and neurological exams. The medical tests will vary dependent on the participant specific needs. Being in the study requires attending in person at the study clinic for at least one day. (IRB#: IRB_00146008)
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)
Autonomic Function in Huntington's disease
Huntingtons disease is when nerves in the brain break down which can cause a decline in health such as difficulty moving and thinking. This study will test how the autonomic nervous system controls functions of the body such as sweating, heart rate, and blood pressure in people with Huntington's disease. The study wants to see if the autonomic nervous system is impaired in people with Huntingtons disease and how it relates to disease progress. People in the study will have medical exams and answer questions. Being in the study requires attending about 4 in-person visits at the study clinic over about 2 years. (IRB#: IRB_00179305)
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)
BI 1015550: A Study Drug to Improve Lung Function in People with Progressive Fibrosing Interstitial Lung Diseases (PF-ILDs)
Progressive Fibrosing Interstitial Lung Diseases (PF-ILDs) is a disease that causes lung function to be difficult such as breathing. BI 1015550 is a study drug to help people with PF-ILDs. Research is needed to know the safety, effectiveness, and side effects BI 1015550. The information we gain may aid future patients. (IRB#: IRB_00158440)
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 Stimulation for People with Cervical Dystonia
Cervical Dystonia is a condition that causes involuntary muscle contractions in the neck. This study will test the effects of brain stimulation on cervical dystonia, related symptoms, and well-being. The study wants to see if brain stimulation helps people and is safe. Being in the study requires applying a small device on the top of the head over a specific area of the brain. This allows brain activity to be measured before and after brain stimulation. Participants will have images of the brain taken with MRI and fMRI. Participants movement, mental and emotional well-being, and feelings about participating in research will be assessed. Participation lasts about 5 weeks and includes frequent in-person visits at the University of Utah study clinic. People will be paid for participation. (IRB#: IRB_00165129)
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)
CARRA Registry for People with Pediatric Rheumatic Diseases
Rheumatic diseases affect joints and can cause chronic severe pain. This study will collect information that includes cognitive and behavioral testing to learn how effective medication is in treating people with pediatric rheumatic diseases. The study wants to see how thinking abilities change over time in people with this disease. People in the study will complete a computer-based survey once a year for 5 years. The survey tests cognitive and behavioral abilities and lasts about one hour. Participants will be paid for each survey completed. (IRB#: IRB_00083072)
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)
Characterization of Individuals with Leukodystrophy
Leukodystrophy is a disease that affects the white matter. The white matter is the area of the brain through which messages are sent. Leukodystrophies can have many causes, some known and some yet to be known. There are no specific tests to help establish the cause or diagnosis. This study will collect information on people with leukodystrophies. Being in the study requires people to share their health information. This will be analyzed to better understand leukodystrophies and to improve ways to diagnose the health condition. (IRB#: IRB_00019596)
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)
Computer Model of Abnormal Heart Rhythm
Arrhythmias is the improper beating of the heart. This study wants to learn more about peoples arrhythmias from the heart's upper chamber. This happens when people have had an ablation for a heart condition called atrial fibrillation (rapid heart rate). An ablation is done to improve the heart condition. People in the study will be planning a redo ablation and have procedures that generally take place and are not done specifically for the study, such as an MRI (a tool used to see inside the body). This will help show areas of scar tissue in the atrium. Additional ablation may also take place. Being in the study requires attending regularly scheduled in-person visits to the clinic related to ablation. Medical information will be collected to see the heart's rhythm for up to 5 years. This study will use scar information to make a computer model of the arrhythmia and use that to guide treatment. (IRB#: IRB_00128325)
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 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)
Creating an Educational Tool for People Using Anticoagulants
Anticoagulants are drugs used to thin the blood and stop the blood from clotting. The drug is already approved for use. The study wants to develop an online tool to teach people about the drug. The study wants to learn what people need to create the tool. People in the study will participate in person at a study clinic for about 30-60 minutes of interviews. People will also spend time using the tool while being observed and video recorded. Participants will be paid for being in the study. (IRB#: IRB_00175039)
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)
Cultural Adaption of Native Hawaiian and Pacific Islander Postpartum Depression Support Group
In Utah, Native Hawaiians and Pacific Islanders have higher rates of Postpartum Depression than other racial/ethnic groups. Utah has support groups available to mothers in the postpartum period, but available support groups do not integrate Native Hawaiian and Pacific Islander culture into the curriculum. This study will learn about experiences from mothers who are members of the Native Hawaiian and Pacific Islander community in Utah and have given birth within the last 5 years. People in the study will participate in a group discussion virtually using Zoom to share experiences. (IRB#: IRB_00185936)
Deep Brain Stimulation Surgery for People with Treatment Resistant Depression
This study wants to learn the benefits of surgically implanting a deep brain stimulation (DBS) system to help people with major depressive disorder. People in the study will have had at least 4 other treatments during current depression or throughout the lifetime, but none have fully helped the symptoms of depression. People in the study must first qualify for having brain surgery to implant the DBS system. This is done by attending multiple visits with study psychiatrists and medical exams at the study clinic. Participants that qualify will have the DBS system implanted and temporarily transfer psychiatric care to the study psychiatrist from Huntsman Mental Health Institute for at least 12 months. Being in the study lasts about 36 months. Medical tests will be done during the study to track the health of participants. (IRB#: IRB_00175654)
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)
Developing a New Method for Measuring Brain Health in Retired Athletes
This study will learn the effects of repetitive head impacts and sport-related concussions sustained during college athletics. Many people with sport-related concussions can experience difficulties in thinking, managing emotions, and motor functions. This study seeks to develop a new, more sensitive, and specific neuroimaging (pictures of the brain) measurement tool for athletes' brain health. People in the study will be interviewed and complete a test to collect information about the ability to daily think, function, and general mood. This is to see what changes may have occurred since the first injury. Participants will also have brain pictures taken using magnetic resonance imaging (MRI) and magnetic resonance elastography (MRE). The brain pictures help to understand if changes occurred compared to imaging done around the first time of the injury. Participation requires attending a 3-hour in-person visit at the study clinic. The information collected could be used in future research on brain health and function. (IRB#: IRB_00160823)
Digital Storytelling Study for Young Cancer Survivors
The purpose of this study is to understand the experiences of people ages 15 to 39 years old who face cancer. The study wants to learn what supports improve the quality of life when going through cancer and after the treatment is completed. Being in the study requires completing two 5-minute surveys and participating in digital storytelling by being in a private online chat group for 12 weeks. Each week participants will respond to 2-3 questions about health related to the quality of life. Participants will be paid for being in the study. (IRB#: IRB_00172717)
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)
Duloxetine for People with Fibromyalgia
Fibromyalgia is a long-lasting pain condition. Duloxetine is a common approved drug used to treat people with this condition. Peoples responses vary when taking the medication. Some people find the drug to be helpful, a little helpful, while others do not. This study wants to understand better the reasons for varying responses to Duloxetine. People in the study will already have been taking Duloxetine for at least 2 months to help with Fibromyalgia. Being in the study requires attending one 5-6 hour visit to the study clinic. The visit will include completing a survey and having blood drawn. People will receive payment for completing the study. (IRB#: IRB_00167537)
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)
Early Upper Endoscopy During Food Reintroductions in Eosinophilic Esophagitis
Eosinophilic Esophagitis (EoE) is a digestive disease that can occur due to food allergy and affect the ability to swallow. This study will learn more about how a persons body develops EoE for new medications and tests that can treat and identify EoE. People in the study will have already chosen to eliminate 1 or 2 foods to treat EoE with a doctor. Once participants resolve the disease with an elimination diet, the participant with the doctor will reintroduce foods (one at a time) to identify which foods are causing EoE. Each food reintroduction takes 6-8 weeks. Participants will have a follow-up endoscopy with biopsies after each food reintroduction as part of the standard of care. The study participation time will vary according to how many foods are removed from the participants diet. It can be as short as 6-8 weeks or up to 6 months, depending on having one or two foods removed and reintroduced. Medical tests will be done during the study to track the health of participants. (IRB#: IRB_00183050)
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)
Emergency Medical Professionals and Diagnosed or Suspected ADHD
Symptoms and behaviors of Attention Deficit Hyperactivity Disorder (ADHD) are commonly thought to be characteristics and traits of persons working in an emergency medical services setting. This study is being done to better understand the people working in emergency medical services. The study wants to identify possible risks to mental health and wellness of these people. The study hopes to improve training and education of people entering and continuing education in the field of emergency medical services. People in the study will complete a survey that lasts about 20 minutes. (IRB#: IRB_00179836)
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)
EPX-100: A Study Drug for People with Dravet Syndrome
Dravet Syndrome is a rare, severe epilepsy disease that appears during the first year of life. EPX-100 is a study drug to help people with this disease. Research is needed to learn the safety and effectiveness of the study drug. Information we gain may aid future patients. (IRB#: IRB_00155489)
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)
Exercise Timing, Sleep, and Diabetes Risk
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_00179948)
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)
Exploring Exercise Intolerance for People with Postural Orthostatic Tachycardia Syndrome
Postural Orthostatic Tachycardia Syndrome (POTS) is a condition that causes uncomfortable symptoms when a person is lying down and sits or stands up. Often, people with this condition suffer from not being able to tolerate exercise. Exercise is the most effective way to treat the condition without taking medication. This study wants to learn more about the effect of exercise on people with POTS to help people with this condition. People in this study will complete surveys and attend 2 in-person study visits at a study clinic. Participation in the study lasts about 3 months. Medical tests will be done to track the health of participants. (IRB#: IRB_00145829)
Family Caregiving, Work, and Employer Leave Policies
Often caregivers are unpaid family members who also must work for income to live. This may create challenges as these caregivers may need to take time off work. There are no federal paid family leave laws, but some states have policies that help by giving income, job protection and time off for caregiving. This study wants to see how caregiving and work policies impact caregivers well-being. People in the study will participate in a 60-minute interview online via Zoom to share their experiences as a caregiver. People will be paid for study participation. (IRB#: IRB_00185711)
Financial Hardship of All People Living with Dementia and Their Care Partners
Dementia is a condition that can cause memory loss and impair individuals ability to make decisions. The effects of this condition can cause financial hardship. This study wants to develop a survey tool to assess the financial hardship for all people living with Dementia and their care partners. People in the study will answer brief questionnaires and participate in online group discussions using a technology device such as a computer. Participation lasts about 90 minutes. Participants receive $75 for participation. (IRB#: IRB_00179914)
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)
Foot and Ankle Shape Differences in Children and Teens with Various Types of Charcot Marie Tooth Disease
Charcot Marie Tooth (CMT) disease causes changes in the foot and ankle that can lead to pain and loss of function. This study intends to identify potential differences in bone and muscle structure between children and teens ages 8 to 18 years old with and without CMT. The study also wants to know the difference between genetic subtypes of CMT. This study will learn more about the disease to help develop new treatments. Participants with and without CMT will have two types of medical imaging done to make models of the bones and muscles in the foot and ankle. Participants with CMT will also receive genetic testing to identify their specific subtype of CMT. Participation lasts about 8 hours for those with CMT or 6 hours for those without CMT. Medical tests will be done throughout the study. (IRB#: IRB_00172882)
Genetic Testing of Juvenile Idiopathic Arthritis
The definition of Juvenile Idiopathic Arthritis (JIA) is unknown. It is believed that inherited factors (genes) contribute to the development of JIA including the type and course of the disease. JIA can cause pain, swelling, and stiffness in the body's joints. The study will try to identify genes and gene structures (Epigenetics) that are involved with JIA. The study wants to better understand why the disease develops in one person and not others. The information will help to develop effective treatments for people with JIA. People in the study will have medical tests done to collect genetic information. Being in the study requires attending in person at the study clinic. (IRB#: IRB_00009524)
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)
Glucose Monitoring and Behavior in Adults with Prediabetes
Prediabetes is a health condition where blood sugar levels in the body are higher than usual but not yet high enough to be diagnosed with type 2 diabetes. Prediabetes increases the risk of having type 2 diabetes and other health problems like heart disease. This study wants to help people with prediabetes make healthier food choices to manage their blood sugar better and lower the risk of other health issues. Being in the study requires wearing a continuous glucose monitor, a small device on the arm that tracks blood sugar throughout the day, and using a smartphone app to see what influences eating behaviors. The app will ask questions about hunger, cravings, and mood at different times during the day. This study will see if using the device and smartphone app is helpful for people and if information is given about when people are most likely to make unhealthy food choices. Participation lasts 4 weeks and requires 3 in-person visits at the study clinic. (IRB#: IRB_00184453)
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)
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 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)
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 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)
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)
Influence of Working Memory for Sentence Interpretation in Second Language
Word Memory capacity (WMC) varies based on the language a person uses. Second language English speakers generally require more cognitive demands in tasks compared to native English speakers. However, stronger English skills are linked to better WMC. This study wants to see how Working Memory influences sentence interpretation in Second language English speakers. People in the study will complete cognitive tests to recall information, read several sentences and answer questions about the sentences, and share personal and educational background. Being in the study lasts about 30 minutes. (IRB#: IRB_00187409)
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)
Intracept Procedure for People with Low Back Pain
Vertebrogenic low back painis caused by damage to parts of the spine called vertebral endplates. The damage can develop over time with the wear and tear on the back that comes from everyday activities. Vertebrogenic pain is usually felt in the middle of the low back and is often made worse by physical activity, prolonged sitting, bending forward, and lifting objects. The Intracept procedure is a treatment for low back pain. The procedure targets the basivertebral nerve, which is the nerve that sends pain signals from damaged endplates. The treatment has been shown to relieve pain long-term. This study will collect information from participants who are already scheduled to be treated for low back pain using the Intracept system. Participants in the study will complete surveys before and after the procedure. Participants may be asked to have a magnetic resonance imaging (MRI) of the lower back. An MRI is a tool used to take images of inside the body. Being in the study requires attending up to 12 study visits at the study clinic or at home. The study will track the health of participants for about 5 years after the Intracept treatment. (IRB#: IRB_00186240)
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)
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)
Magnetic Resonance Imaging Development
Magnetic Resonance Imaging (MRI) is done to form pictures of inside the body. An MRI helps diagnose health issues. The purpose of this study is to improve MRI for better health diagnoses and exam experience. Being in the study requires attending one in-person study visit to have an MRI. The MRI procedure is conducted by lying down in a long cylinder. The study visit will last about 2 hours. (IRB#: IRB_00075295)
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)
Mental Health Training Needs in Utah Schools
There are often big gaps in training for mental health workers, especially in rural areas. Studies show that time, cost, and access are big barriers to using the best methods in mental health practice. A new study in Utah wants to find out what training is needed for mental health workers in schools, to help them better meet the needs of students. (IRB#: IRB_00156144)
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)
Mirum VISTAS
The purpose of this clinical research study is to learn more about the use of the study medicine, volixibat, for the treatment of pruritus (itching) associated with PSC. Volixibat is an experimental treatment, meaning that it has not yet been approved by the US Food and Drug Administration or any worldwide regulatory body. Volixibat is a medicine that lowers circulating bile acid levels that are believed to lead to the itching in patients with PSC. There are no other medicines approved to treat itching in patients with PSC. This is the first time volixibat will be used in patients with PSC. (IRB#: IRB_00137626)
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)
Morals and Emotions
The purpose of this study is to learn about the relationships between a persons feelings and social attitudes. Being in the study requires completing 16 short surveys using text messaging over 4 days. The total time spent in the study is about 1.5 hours. (IRB#: IRB_00181964)
Mothers' Infant Feeding Strategies and Wellbeing
We are looking for pregnant and new mothers and those who work with them (such as doulas, midwives, and lactation consultants) to participate in a research study about feeding experiences and maternal mental health and wellbeing. This study aims to understand new mothers' experiences with feeding their infants and how these experiences are related to their wellbeing. We are interested in the messages women receive and the policies that impact their feeding strategies and experiences. (IRB#: IRB_00189272)
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)
Motor Learning and Memory
This study will see which brain regions support motor learning skills and memory. Participants will complete surveys and motor tasks (finger tapping) and wear an actigraphy (device worn on the wrist to track motion). People will also experience Magnetic Resonance Imaging (MRI). An MRI will be done to scan and take images of the brain. Transcranial electrical stimulation (TES) will also be used as a painless way to stimulate specific brain areas using a small device placed on top of the head. These activities allow seeing the brain's motor learning and memory processes. People will attend two in-person visits that last about two hours each at the study clinic over two days. (IRB#: IRB_00183830)
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)
Near Infrared Spectroscopy to Detect Acute Kidney Injury During Cardiac Surgery
Acute kidney injury (AKI) is a complication of cardiac (heart) surgery. Near Infrared Spectroscopy (NIRS) is a technology that uses light to determine how well-oxygenated a persons body tissues are. This technology is routinely used in cardiac surgery to measure the oxygen level in a persons brain by placing a sensor sticker on the forehead. This study wants to test whether NIRS sensor stickers placed on the skin over the kidney can predict AKI better than when sensors are placed on the skin over the limbs such as the arms and legs. People in the study will receive normal care for cardiac surgery along with adding more sensor stickers placed on the body. Medical tests will be done during the study to track the health of participants. (IRB#: IRB_00179157)
Needs Assessment of Young Adult Rural Cancer Caregivers
Young adult rural cancer caregivers experience unique challenges. These include mental health, financial hardship, and unmet social needs. This study wants to better understand the needs and challenges of young adult rural cancer caregivers. The information will help develop and test interventions to improve young adult rural cancer caregiver experiences. Being in the study requires completing a 15 to 20-minute online survey. Participants will also complete a 30 to 45-minute online video interview. Participants will be paid for being in the study. (IRB#: IRB_00180551)
NEURONA: 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). Research is needed 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 gained may aid future patients. (IRB#: IRB_00157503)
New Food Allergy Test for People with Eosinophilic Esophagitis
Eosinophilic Esophagitis (EoE) is when the esophagus (which connects the throat to the stomach) becomes inflamed, causing heartburn and swelling and making it hard to swallow. EoE commonly occurs due to food allergy. Current allergy tests cannot tell which foods are causing the problem. This study will test whether a new allergy test called esophageal antigen test (EAT) can accurately detect food allergies. People in the study will have esophageal secretions (mucus) collected during an upper endoscopy procedure to test for food reactions. People will be randomly chosen to have food-elimination diets. Being in the study requires attending in-person study visits at the study clinic. Medical tests and surveys will be done every two weeks to track participants' health. After 6-8 weeks, the upper endoscopy will be repeated to see whether the food allergy test was accurate. Participation will last between 3 and 18 months. (IRB#: IRB_00181557)
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)
Obinutuzumab: A Study Drug for Lupus Nephritis
Obinutuzumab is a study drug to reduce the B cells of lupus nephritis. The drug is currently approved for certain blood type cancers such as leukemia and lymphoma. However, scientists and doctors do not know the effectiveness of the treatment for patients with lupus nephritis. Research is needed to learn if the drug may be approved and used to improve the health of people suffering from lupus nephritis. (IRB#: IRB_00145715)
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)
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)
Perception During a Manual Task
This study will look at how sounds affect a persons task performance and perception of environmental hazards. Participants will complete a manual labor task (such as using a hand drill) while listening to common background sounds. The study will measure task performance from time and accuracy in completing the task. Participants will complete surveys, body movement, and brain activities. Being in the study requires attending one 5-hour in-person visit at the study clinic. The study wants to learn how to improve workplace safety better. (IRB#: IRB_00184556)
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)
Perspective of Time and Goals
This study will look at how people think about time and how their goals and priorities may change as they age. The study will learn if peoples beliefs about life, the future, and what happens after death affect what people value at different stages of life, depending on whether they are religious or non-religious. People in the study will complete an online survey for less than 15 minutes. People will then participate in one 60-minute online interview using Zoom. Participants will answer questions about views on time, personal goals, and beliefs about an afterlife. The information learned will help better understand how people make decisions and set goals. (IRB#: IRB_00184731)
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)
Predicting and Understanding Pelvic Organ Prolapse
Pelvic organ prolapse occurs as pelvic muscles and tissues weaken causing health issues such as urinary and bowel problems. This study will look at the potential of a type of magnetic resonance imaging (tool used to take pictures of the inside of the body) called diffusion tensor imaging (DTI) to understand how the disease progresses. The study wants to see if DTI could be used to diagnose pelvic organ prolapse much earlier in its progression. People in the study will complete a survey, medical exam, and an MRI. Being in the study requires attending 2 in person study visits at the clinic. (IRB#: IRB_00165757)
Predicting Disease in the Esophagus
The esophagus is the tube that allows people to swallow. This study wants to learn more about how to predict disease in the esophagus. Participants will have been referred for an esophagogastroduodenoscopy (EGD). This is a procedure where a small tube with a camera on the end is passed into the esophagus, stomach, and first portion of the small intestines. This is done to see the inside of these organs and look for any disease. Being in the study requires participants to share results from the EGD. Other medical tests will be done to collect study information such as spitting in a tube and having blood drawn. (IRB#: IRB_00101871)
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 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)
Primary Children's Hospital Genomics and Children's Health
Genes are made up of DNA that can determine the impact on a persons health. This study will collect, store, and evaluate genetic and health information. This study wants to learn more about the role of genetics and improve the ability to find causes for a persons health conditions. Participants in the study will have or will complete genetic testing. This is done by having a member of a medical team collect a small sample of the body such as blood. Participant medical records will be reviewed during the study. Surveys may be taken and last about 10 to 60 minutes. Surveys are optional. Participants information will be stored for future studies. (IRB#: IRB_00178148)
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)
Psychedelic Use and People with Neurological or Musculoskeletal Injuries
This study wants to understand better the experiences of people who have had neurological or musculoskeletal injuries, including spinal cord injury, brain injury, stroke, and limb loss, in relation to using psychedelics (a type of drug). People in the study will complete a survey that lasts about 10 minutes. The survey will help the study learn about peoples experiences using psychedelics. The study wants to see how these experiences have influenced the ability to adapt to an injury/disability, mental health, and any medical symptoms or side effects. (IRB#: IRB_00175868)
Pyruvate Kinase Deficiency Global Longitudinal Registry
Polycystic Kidney disease (PKD) is a rare blood disease. PKD affects both children and adults and can cause severe health conditions, especially in young children. People with PKD lack pyruvate kinase R, a specific protein in the body needed for healthy red blood cells. There is currently no cure for PKD. The Pyruvate Kinase Deficiency Global Longitudinal Registry aims to help better understand PKD and improve medical care. This Registry collects information from patients during routine medical care. Participants past, present, and future medical records will be shared with the Registry database. Participation will last 2 to 9 years. (IRB#: IRB_00109616)
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)
Real-World Study of ABBV-951 to Assess Change in Disease Activity in Adult Participants With Parkinson's Disease
Parkinson's disease (PD) is a neurological condition, which affects the brain. PD gets worse over time and how quickly it progresses varies from person to person. Some symptoms of PD are tremors, stiffness, and slowness of movement. ABBV-951 is an approved drug for the treatment of PD. This study will see how well ABBV-951 is in treating adult participants with advanced PD in real world setting such as daily living activities, disease progression, and sleep quality. People in the study will receive ABBV-951. Being in the study requires attending regular in person visits at the study clinic for about 3 years. Medical tests and surveys will be done during the study to track the health of participants. (IRB#: IRB_00178644)
Reducing Harmful Bacteria in the Mouth with Twice-Daily Tooth Brushing
This study will test a new toothpaste that may help reduce harmful bacteria in the mouth, specifically Streptococcus mutans (S.mutans), which is known to cause cavities in teeth. The new toothpaste targets these harmful bacteria while supporting the growth of good bacteria that help keep the mouth healthy. The study wants to see if the daily routine with the toothpaste lowers the levels of S. mutans and improves the overall balance of bacteria in the mouth, which may help reduce the risk of cavities. Participants in this study will brush their teeth twice a day with the assigned toothpaste for 28 days. Being in the study requires attending 3 in-person visits at the study clinic. (IRB#: IRB_00182886)
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)
Registry Study of Macular Telangiectasia Type 2
Macular telangiectasia type 2 (MacTel Type 2) is an uncommon eye disorder causing slow vision loss in middle age. The macula is the central part of the retina, which lines the back of the eye like the film of a camera. The macula allows central vision, which is vital for reading and driving tasks. Telangiectasia refers to dilated, leaky blood vessels. There are no approved treatments to prevent the loss of vision that occurs in many, but not all, eyes with MacTel Type 2. This study aims to create a registry of persons with MacTel Type 2, their immediate family members, healthy volunteers, and persons with related disorders. This registry will enable clinicians and scientists to understand better the characteristics of MacTel Type 2. Information learned may help find a way to prevent or treat this eye condition. People in the study will attend one visit to the clinic for medical, ocular (eye), and medication histories, genetics blood draw, visual acuity testing, comprehensive eye exam, and ocular imaging. People will be invited to register in the MacTel Project Contact Database. Registration is done online and is voluntary. Contact information will be collected to provide new information or treatments learned about MacTel if a person chooses to register. (IRB#: IRB_00045548)
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)
Remotely Monitoring Function after Stroke
This study will assess remote approaches to measuring a persons daily function at home after a stroke. These include home video recordings, online surveys, and wearable activity monitors such as Fitbit. The information learned will improve measuring functions to help know the impact of clinical interventions. Being in the study lasts about 14 weeks and requires no in-person study visits. Study activities will be completed at home. People are paid for participation. (IRB#: IRB_00173989)
Researching Biopsies of People with Aggressive Cutaneous Lymphoma
Aggressive cutaneous lymphoma is a rare and life-threatening cancer with limited treatment options. Participants will not receive treatment/medication for the condition in this study. This study will observe participants with aggressive lymphomas and their previously collected biopsies to learn more about lymphomas and their response to different treatments. Being in the study requires participants to share medical records and previous biopsies of skin tissue to be tested, shared with other researchers, and stored for future research. (IRB#: IRB_00143860)
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)
Ruxolitinib Cream for Children with Nonsegmental Vitiligo
Nonsegmental Vitiligo is a skin disease that causes loss of pigment (color) in patches of the skin on the face and body. Ruxolitinib is an approved cream for older children and adults. This study will see how well the cream works for children 2 to 11 years old. Participants will apply the cream at home to treat the areas of skin twice daily for up to 1 year. Being in the study requires attending about 8 in person visits at the study clinic. Medical tests will be done throughout the study to track the health of participants. (IRB#: IRB_00182881)
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)
Semaglutide and Adult Metabolic Health
Semaglutide (known as Ozempic and Wegovy) is a type 2 diabetes and/or weight loss drug. Semaglutide is helpful for most people to lose weight, but it is unknown why some people do not experience weight loss or only lose limited weight with semaglutide. It is also unknown if certain people are more likely than others to regain weight if they stop taking semaglutide. This study will see how semaglutide impacts metabolism and the ability to maintain long-term weight loss. The information may improve diabetes and weight management care with semaglutide. Participants in the study will all use the drug semaglutide along with regular medical care. Being in the study requires attending regular in-person medical care visits along with 2 study visits for over 6 to 8 months. Medical tests will be done during the study to track the health of participants. (IRB#: IRB_00181932)
Shared Decision-Making of People with Carotid Artery Stenosis and Their Caregivers
Carotid Arteries are the major blood vessels that carry blood to the brain. Carotid Artery Stenosis is a disease that narrows these arteries and increases the risk of a stroke. This study will learn from people with this disease and their caregivers to help develop guidelines for shared decision-making. Participants in the study will attend a 90-minute focus group to discuss experiences of living with Carotid Artery Stenosis as a patient and caregiver. (IRB#: IRB_00174805)
Shared Leisure and the Care Partnership of People with Spinal Cord Injury
This study wants to learn shared leisure experiences and the care partnership of people with spinal cord injury and their informal caregivers. People in the study will complete a survey and participate in a one-hour interview. Participants will be paid for study completion. (IRB#: IRB_00187021)
Short Chain Fatty Acids Supplements for People with Eosinophilic Esophagitis
Eosinophilic Esophagitis (EoE) is an allergic disease that happens in the esophagus. The disease may cause swallowing to be difficult, vomiting, and heartburn. This study wants to see if taking short chain fatty acids (SCFA) supplements helps people with EoE. People in the study will have an endoscopies, complete surveys, and other medical tests. Participants with active EoE will receive the study treatment twice daily for 8 weeks. Follow up medical tests will be done during the study to track the health of participants. Participants will be paid for study completion. (IRB#: IRB_00185556)
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)
Smart Home Technology for People With Disabilities
This study will look at how smart home technology impacts people with disabilities and their households. Smart home devices, like smart lights, thermostats, locks, and voice assistants, may improve life. This study wants to understand what works well, what is challenging, and what could be improved with smart home technology for people with disabilities. People in the study will complete a 20-minute survey to share experiences using or not using smart home technology. People may also participate in a follow-up interview. (IRB#: IRB_00187713)
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)
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 for People with Essential and Vocal Tremors
Tremors occur when a persons body shakes or moves involuntary. This study will better understand the impact of tremor movement on the parts of the body that are used for speech and voice known as vocal tremor. The information learned will help improve methods for identifying and treating people with vocal tremor. People in the study will share medical records and complete a voice evaluation that takes about 90 minutes. Participants will then complete 2 recording sessions that involve completing surveys, recording breathing, throat muscle activity, and imagining the throat while breathing and talking. The total time spent in the study lasts about 5.5 hours. (IRB#: IRB_00118469)
Study for Personalized Brain Mapping
Functional magnetic resonance imaging (fMRI) is an imaging scan that shows activity in specific areas of the brain. In medical settings, fMRI mainly helps plan brain surgeries and similar procedures. This study will test personalized brain mapping activity in people having brain surgery. Patients will have a fMRI scan for about 1 hour. (IRB#: IRB_00181051)
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 Genetic Causes of Brain Aneurysms
A brain aneurysm can cause arteries within the brain to rupture, leading to bleeding within the brain. This condition can result in a stroke. Brain aneurysms have been known to run in families and people with certain genetic disorders. This study will learn what genetic differences are responsible for the development of brain aneurysms. Being in the study requires blood tests and reviewing medical history. (IRB#: IRB_00177663)
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 to Prioritize Trans Health Across States
This study wants to learn more about how anti-transgender laws and policies affect mental health and access to care for transgender and nonbinary adults. The goal is to understand how personal, social, environmental, and structural factors related to these policies impact mental health outcomes and access to services. This information will help develop strategies for addressing legislative structural stigma and mental health needs and improving healthcare services for transgender and nonbinary populations. People in the study will complete an online survey and/or participate in an interview. Participation lasts about 30 minutes to 1 hour. People are paid to participate in the study. (IRB#: IRB_00181829)
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 Exercise Intolerance Symptoms for People with Long COVID
Exercise intolerance is the need to stop physical activity because of symptoms like shortness of breath and fatigue. Post-exertional malaise (PEM) is the worsening of symptoms after minimal physical, mental, or emotional activity. PEM symptoms include difficulty with physical activity (exercise intolerance), difficulty thinking, trouble sleeping, sore throat, headaches, muscle aches, dizziness, or severe tiredness. This study will find out if certain study interventions can help treat exercise intolerance and post-exertional malaise that started or got worse after a COVID-19 infection and has lasted for at least 3 months. Based on symptoms and then by chance, people in the study will be in one of two groups. One group will receive exercise training with education to help with exercise intolerance and improve quality of life and ability to exercise. The other group will receive a training intervention designed to help people with PEM to know, control, and minimize PEM symptoms. People in the study will wear an activity tracker on the wrist connected to the smartphone. Being in the study lasts about 6 months. (IRB#: IRB_00179021)
Studying How Consumers Make Purchasing Decisions
This study will explore new ways of learning how people make decisions about what to buy. This study wants to better understand how people make purchasing decisions and their feelings about products. People in the study will do one or more of the following tasks: answer surveys, provide responses to writing prompts, and demographic information. The information will help businesses improve customer experiences and better meet peoples needs. (IRB#: IRB_00182272)
Studying Human Cognition Using Electrophysiological Monitoring for People with Neurological Disorders
Electrophysiological monitoring is a study device placed on the brain to record brain signals responsible for human behavior such as language, memory, and decision-making. This study will better understand human cognition (thinking) and human epilepsy (a neurological disorder of the brain causing seizures) in people having neurosurgery for epilepsy that does not respond to medication or deep brain stimulation. The study lasts about 15 to 30 minutes while having the already planned surgery along with a follow-up visit 6 to 9 months after surgery. (IRB#: IRB_00153370)
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)
Studying Tissue of People with Epilepsy
Epilepsy is a disorder in the brain that causes seizures. This study aims to identify chemical markers in the tissue of people with Epilepsy. The study wants to help people who continue to experience treatment-resistant seizures and suffer from cognitive impairments. People in the study will provide a tissue sample, medical and family history, and lifestyle information. Being in the study requires two visits to the study clinic. One is to collect the tissue sample, and the other is a standard follow-up visit. (IRB#: IRB_00170307)
Suicide Risk of Domestic and International Students in Higher Education in the United Kingdom and South Korea
Education is important to South Korea's development since the republic's birth in 1948. Strong emphasis on education has created a highly competitive and harsh education climate. This may impact the rising rates of academic stress and poor mental health among students in the nation. This study wants to learn the risk of suicide among South Korean students who are studying in the UK higher education institutions and their home country. This study will see how academic pressure predicts poor mental health and suicide risk. People in the study will complete online surveys that will take up to 10 minutes. (IRB#: IRB_00183413)
Sweet Dreams/Dulces Suenos
The purpose of this study is to learn about how women of color find time to sleep in their busy lives. As well as balancing sleep with other healthy behaviors and life demands. The study also wants to learn the impact of sleep on risk factors for cardiovascular (heart) disease and diabetes. The results from the study will help develop a new intervention to improve sleep for women. Being in the study requires attending a 90-minute in-person visit. During the visit participants will complete an online questionnaire, time use survey, and cardiometabolic assessment. After the in-person visit, participants will wear a Fitbit for 7 nights. During this time, participants will receive text messages each day to answer questions about the previous night and experiences that day. Participants will then complete a second time use survey. Participants will be paid for being in the study. (IRB#: IRB_00179415)
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 Brain Device for People Using Opioids for Chronic Pain
People with chronic pain are often prescribed long-term opioid medication. This study will test how a device activates the brain and impacts health symptoms. This study wants to develop better ways to help people with chronic pain. People in the study will complete surveys, medical exams, and interviews. Being in the study requires attending about 7 in-person visits at the study clinic. Each visit varies in time ranging from about 1 to 3.5 hours. Participants will receive $350 for full study completion or $15 per hour for incompletion of all study visits. (IRB#: IRB_00179276)
Testing a Gaming Approach to Improve Health for People with Atrial Fibrillation, Diastolic Heart Failure, or Obesity
This study will explore whether game-like elements can help people with health issues like atrial fibrillation (an irregular heartbeat), diastolic heart failure, or obesity. The study wants to see if reward-based, friendly competition and community support can encourage participants to reach health goals, like staying active, eating healthier, and tracking symptoms. Participants will sign up online and complete surveys about activity levels, diet, energy levels, and health symptoms. Through a website called Gardens, participants will log progress, earn points for staying active and completing health tasks, and monitor their health. Points will be redeemed for prizes, like gift cards or free wellness classes, and participants will see rankings on a leaderboard. (IRB#: IRB_00184498)
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 Study Drug (Lutikizumab) for Adults and Adolescents with Abbvie Hidradenitis Suppurativa
The purpose of this study is to assess the safety and efficacy of lutikizumab compared with placebo (fake drug) for the treatment of signs and symptoms of moderate to severe hidradenitis suppurativa (HS) in adult and adolescents subjects (16 years of age or older were permitted). People in the study will be randomly chosen to be treated with Lutikizumab or a placebo for the first 16 weeks. The placebo looks like the drug but does not have the medication. The drug and placebo are taken as an injection under the skin. At Week 16, patients will be randomily assigned to receive lutikizumab every week or every other week. 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 1 year. Medical tests will be done during the study to track the health of participants. (IRB#: IRB_00178446)
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 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 3 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 Help Transition of Care for People with Congenital Heart Disease
Congenital heart disease (CHD) is one of the most common birth defects with most major effects diagnosed in infancy. There is no cure for CHD. It is a lifelong chronic illness. This study will test an educational video game to help young people with CHD. Being in the study requires testing the video game on a phone, computer, or tablet. Participants will provide feedback about the video game through a survey. People will be paid for participation. (IRB#: IRB_00179379)
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 a Voice Assessment Tool
This study wants to test how the body responds to participation in creative arts activities. People in the study will be asked to complete two in-person visits at the study clinic. During the visit, participants will produce several voicing tasks wearing a face mask or a mouthpiece. Participants will be asked to rate their experience in using these devices. The activity will be measured, and information will be collected. Participants will be paid for being in the study. (IRB#: IRB_00180249)
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 Additional Implanted Microelectrodes During Monitoring for Epilepsy Surgery
Epilepsy is a disorder in the nerve cells of the brain that can cause seizures. A microelectrode is a group of small wires used for recording brain activity. Microelectrodes help to understand epilepsy. This study will use microelectrodes to study seizures. People in the study will already be planning to have surgery for seizures. During surgery, people receive the same treatment and have an additional bundle of wires implanted along with standard electrodes into the brain. These will be removed at the end of the standard hospital stay. (IRB#: IRB_00114691)
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 Antifungal Treatment for Children and Adolescents with Uncomplicated Candidemia
Candidemia is an infection in the blood that can cause hospitalization. An antifungal treatment is done to help the condition. This study will test whether a 7-day antifungal treatment is more effective for adults and children compared to a standard 14-day course, with a lower risk of negative drug-related events. People in the study will be randomly chosen to be treated with the 7-day anti-fungal treatment or the 14-day course. Being in the study requires in-person visits at the study clinic and lasts about 21 days. Medical tests will be done to track the health of participants. (IRB#: IRB_00174179)
Testing Balance after Concussion
A mild traumatic brain injury (mTBI) also known as a concussion can occur when a person's head is hit by something or violently shaken. This study will learn how concussion affects balance and walking. Being in the study requires a persons balance and walking to be tested. People in the study will attend one visit to the study clinic. The visit will last about 3 hours. People will be given a small device to wear for 7 days to record normal daily activities. People will receive payment for participation. (IRB#: IRB_00180660)
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 COMP 360 Drug 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. The study wants to investigate the efficacy and safety of COMP 360 for treatment resistant depression. People in this study will be randomly chosen for COMP 360 doses: 1mg, 10mg, and 25mg. The drug is taken as a swallowed pill. Being in the study requires participation for 55 to 62 weeks. Participants will attend clinic visits in person at a University of Utah Treatment-Resistant Mood Disorders clinic. Medical tests will be done during the study to track the health of participants. (IRB#: IRB_00159931)
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 Effects of Wearable Sensors on Heart Implant Devices
This study tests heart implant response to wearable sensors using smartwatches and smart scales that measure health, such as weight and stress. People in the study must have a heart implant pacemaker or defibrillator more than 3 months before participation. People in the study will wear a smartwatch and stand on a smart scale. Participants will attend one in-person visit at the study clinic for about 1 hour. Medical tests will be done to track the health of participants. (IRB#: IRB_00177524)
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 Electrical Stimulation and Immune Input into the Brain
This study will test electrical stimulation to learn more about the relationship between the brain and the immune system. The immune system protects the body from harmful infections or diseases. People in the study will have electrodes (small device that allows electricity to or from a person's body) placed onto the brain during an already planned upcoming surgery. The electrodes are used to help locate where seizures start in the brain. Brain stimulation and recordings will occur in addition to the standard stimulation and recording performed as a part of epilepsy care. Medical tests will be done during the study to track participants' health. (IRB#: IRB_00159025)
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 Pirfenidone in People with Progressive Pulmonary Fibrosis
Progressive Pulmonary Fibrosis (PPF) is a lung disease where lung tissue scars and thickens over time. This study will test a new drug called AP01, an inhaled version of a medicine called Pirfenidone, in people with PPF. The study wants to see if AP01 (inhaled pirfenidone) will help people with PPF and is safe. People in this study will be randomly chosen to be treated with AP01 or placebo. The placebo looks like AP01 but does have the medicine. AP01 and placebo are given by breathing 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 13 clinic visits. Participation lasts about 60 weeks. Medical visits will be done during the study to track the health of participants. (IRB#: IRB_00184324)
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 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 New MRI Methods for People with Heart Disease
Magnetic resonance imaging (MRI) is a tool used to take an image of the inside of the body. There are previous and newly developed heart MRI methods to assess heart diseases. This study wants to better understand the use of these MRI methods to help people with health issues such as heart disease. People in the study will have an MRI which includes lying down inside of a cylinder and laying still for a certain amount of time. Being in the study requires attending at least one MRI appointment that will last up to 2.5 hours. (IRB#: IRB_00185568)
Testing Omega-3 Fatty Acids in People with Depression
Current treatments for depression are not ideal for some people. The increase in dietary intake of polyunsaturated fatty acids (PUFAs), such as omega-3 fatty acids, might help treat depression, especially in depressed people who have highly active immune cells (ability to fight off diseases). This study will help see if changes in the immune system activity are related to changes in symptoms of depression such as sadness and hopelessness. People in this study will be randomly chosen to be treated with an omega-3 fatty acid supplement or a placebo. The placebo looks like the study treatment but does not have the active treatment. Omega-3 fatty acid is approved and found in health food stores. Being in the study requires 8 visits to the study clinic for about 12 weeks. Medical tests will be done during the study to track the health of participants. (IRB#: IRB_00160768)
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 Povorcitinib for People with Prurigo Nodularis
Prurigo Nodularis is a chronic skin condition known by the presence of hard, extremely itchy bumps known as nodules, which result from persistent, intense scratching and rubbing of the skin. This study will test a drug called Povorcitinib 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 chosen to be treated with one of two doses of Povorcitinib or a placebo. The placebo looks like the study drug but does not have the medication. Later in the study, people in the placebo group will receive one of two doses of Povorcitinib. Being in the study requires attending up to about 15 in-person visits at the study clinic and two phone or video calls over 13 months. Participants will also write daily in an electronic diary. Medical tests will be done to track the health of participants. (IRB#: IRB_00180878)
Testing SERENE-KOKO Device for People with Postpartum Hemorrhage
Postpartum hemorrhage is a condition of excessive bleeding after a person gives birth. This study will test KOKO a device to treat people with this condition. This study wants to see if the device will help people with this condition and if it is safe. People in the study will have abnormal postpartum bleeding within 24 hours after giving birth, and the bleeding will not stop with the use of medication or massage. The KOKO device will then be placed in the uterus to control bleeding for at least 90 minutes. General information about the hospital stay will be collected, including medications that may affect bleeding. At about 6 weeks after giving birth, participants will attend a standard postpartum doctor visit exam. (IRB#: IRB_00181690)
Testing Sirolimus Topical Gel for People with Cutaneous Venous Malformations
Cutaneous Venous Malformations (cVM) are soft, blue, or purple bumps on the skin caused by malformed veins. Sirolimus topical gel is approved by the United States Food and Drug Administration (FDA) to treat other disorders but is a study drug to test for the potential treatment for people with cVM. The study wants to see if the drug will help people with this condition and is safe. People in the study will complete surveys and use Sirolimus topical get on their skin to treat the condition. Being in the study requires attending about 7 study visits. Of these, 6 will be in person visits at the study clinic lasting 1 to 3 hours each. At least one study visit will be on the phone or video call and last 30 to 60 minutes. Medical tests will be done throughout the study to track the health of participants. (IRB#: IRB_00188103)
Testing Step Training and Balance
This study will test the impact of step training on improving balance. This study wants to help enhance fall prevention interventions and physical and cognitive health. People in the study will attend a 5-hour visit at the study clinic. Participation requires completing surveys and a step training activity while wearing sensors to measure heart rate, brain activity, and body movements. (IRB#: IRB_00183429)
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 Diode Laser Device for People with Peripheral Neuropathic Pain
Peripheral Neuropathy is a disorder of the nerves in the body that typically affects the longest peripheral nerves of the body reaching to the feet. The disorder may cause ongoing neuropathic foot pain. This study will test a device called a Diode laser. This device will be used to apply light energy to the skin on top of the foot to activate nerves in the skin that sense pain. The study will see if this testing correlates with the neuropathic pain people experience with the disorder. People with known neuropathy will have opportunities to participate in 2 studies. Study one will assess both the severity of neuropathy, and the severity and history of foot pain. This is a one day 2 to 3 hours in-person visit at the study clinic. Study two will see if change occurs in neuropathic pain from a Federal Drug Administration (FDA) approved medication called Lidocaine, and measure change in response to the laser stimulation in parallel. The medication will be a patch that is placed on the top of the foot. This second study lasts an additional 4 weeks with 4 additional brief weekly in-person study visits at the clinic. (IRB#: IRB_00139059)
Testing the Drug Anifrolumab to Treat Pediatric Patients with Systemic Lupus Erythematosus
Systemic lupus erythematosus (SLE) is a chronic autoimmune disease that can affect various organs of the body, especially the skin, joints, blood, kidneys, and central nervous system. "Chronic" means that it can last for a long time. "Autoimmune" means that there is a disorder of the immune system, which, instead of protecting the body from bacteria and viruses, attacks the persons tissues. Anifrolumab is an approved drug not yet tested in pediatric patients (ages 5 to 18 years old) with SLE. This study wants to see if the drug will help pediatric patients with this condition and is safe. People in the study will receive the study drug Anifrolumab or a placebo. The placebo looks like the drug but does not have the medication. Being in the study requires attending in-person visits at the study clinic for about 2 years and 4 months. Participants will be paid for time spent in the study. Medical tests will be done during the study to track the health of participants. (IRB#: IRB_00167080)
Testing the Drug Barzolvolimab for People with Chronic Spontaneous Urticaria
Chronic Spontaneous Urticaria causes chronic hives that last for 6 weeks or more and appear 3-5 times a week. This study will test a drug called Barzolvolimab 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 Barzolvolimab or a placebo. A placebo looks like the drug but does not have the medication. Being in the study requires completing surveys and attending up to 19 in-person visits at the study clinic for about 72 weeks. Medical tests will be done during the study to track the health of participants. (IRB#: IRB_00179700)
Testing the Drug Belimumab for People with Interstitial Lung Disease Associated with Connective Tissue Disease
Interstitial Lung Disease (lung fibrosis) associated with Connective Tissue Disease is a condition when the body's immune system (the system that fights infection) attacks the bodys own cells and tissues. This study will test a study drug called belimumab to treat people with this disease. The study wants to see if it will help people with the disease and is safe. People in the study will be randomly chosen to be treated with belimumab or a placebo. A placebo looks like the study drug but does not have the medication. Being in the study requires 9 study visits at the clinic over about 1 year. Medical tests will be done to track the health of participants. (IRB#: IRB_00184246)
Testing the Drug Buloxibutid for People with Idiopathic Pulmonary Fibrosis
Idiopathic Pulmonary Fibrosis (IPF) is a disease caused by the build up of scar tissue in the lungs making the lungs unable to work normal. This study will test a drug called Buloxibutid 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 Buloxibutid or a placebo. A placebo looks like the drug but does not have the medication. Being in the study requires up to 8 study visits at the clinic and 8 phone visits over 54 weeks. Medical tests will be done during the study to track the health of participants. (IRB#: IRB_00184934)
Testing the Drug Combination Vedolizumab and Tofacitinib in Adults with Moderate to Severe Active Ulcerative Colitis
Ulcerative Colitis (UC) can cause severe pain and swelling in the lining of the colon and rectum. This study will test combining previously approved UC drugs Vedolizumab with Tofacitinib to treat adults with this disease. The study wants to see if the drug combination will help people with the disease and is safe. People in this study will receive the combination treatment. After the combination treatment people may be eligible to continue receiving Vedolizumab. If not, study participation will end. Being in the study requires attending about 13 in person visits at the study clinic. Study participation lasts up to 1.5 years. Medical tests will be done during the study to track the health of participants. (IRB#: IRB_00184868)
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 4-5 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 Depemokimab for Adults with Hypereosinophilic Syndrome
Hypereosinophilic syndrome (HES) is caused by a high amount of white blood cells, damaging body organs. This study will test a drug called Depemokimab to treat people with HES. The study wants to see if the drug will help people with the syndrome and is safe. People in this study will be treated with Depemokimab or a placebo. The placebo looks like the study drug but does not have the medication. Being in this study requires attending in-person visits to the study clinic about 18 times over 14 months. Medical tests will be done during the study to track the health of participants. (IRB#: IRB_00158126)
Testing the Drug Dexpramipexole in People with Eosinophilic Asthma
Eosinophilic asthma is a condition when there is a high level of white blood cells and a persons airway becomes narrow and swollen making it difficult to breathe. This study will test a drug called Dexpramipexole (Dex) to treat adults with severe eosinophilic asthma. This study wants to see if Dex added to current medications will help people with the condition and is safe. People in the study will be randomly chosen to be in one of three study groups. Two of the groups will receive different doses of the study drug. One group will receive the placebo. The placebo looks like the study drug but does not have the medication. Being in the study requires attending 11 visits over 56 weeks. Ten of the visits will be in person at the study clinic. Each visit lasts about 1 to 3 hours. The last visit will be a telephone call that will last about 30 minutes. Medical tests will be done during the study to track the health of participants. (IRB#: IRB_00178852)
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 ESK-001 for People with Plaque Psoriasis
Plaque psoriasis is a skin condition that causes dry, itchy, raised patches of skin on the body. This study will test a drug called ESK-001 to treat adults 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 chosen to be treated with ESK-001, apremilast (a drug used to treat the same condition), or placebo. A placebo looks like the study drug but does not have the medication. Being in the study requires attending in-person visits at the study clinic for about 24 to 32 weeks. Medical tests will be done to track the health of participants. (IRB#: IRB_00180229)
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 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 Inclisiran for Adults with Atherosclerotic Cardiovascular Disease
This study will test an approved study drug, Inclisiran, to treat people with heart disease to see if it lowers bad cholesterol. The study wants to see if the drug will help people with the disease. People in the study will be randomly chosen to be treated with Inclisiran for the first 12 months (Part 1) of the study. If people in the study did not receive Inclisiran during Part 1 of the study, they will continue participation for another 12 months (Part 2) and receive Inclisiran in the second 12 months. Being in the study requires attending 4 or 7 in-person visits at the study clinic, which lasts 12 or 24 months, depending on the assigned group. Medical tests will be done to track the health of participants. (IRB#: IRB_00177770)
Testing the drug ION356 for males with Pelizaeus-Merzbacher Disease
Pelizaeus-Merzbacher Disease is a disease that causes impairment of the neurons in someone's brain and spinal chord. Neurons are a special type of cell that transmit and receive signals throughout the central nervous system. They send signals to different parts of the central nervous system through the axon of the neuron that is covered in myelin. Myelin helps the signals get from one neuron to another. A protein called PLP1 helps form myelin, and those with PMD have abnormalities with PLP1 that causes little or no myelin to be formed. This makes it difficult for the signals to make it to the next neuron which causes problems in the nervous system. This study wants to see if the drug ION356 will help people with this disease and determine if the medication is safe. Everyone in the study will be treated with the study drug. Being in this study requires up to 22 visits to the study clinic with 3 overnight stays and 31 phone calls over 3 years. Medical tests will be done to track the health of the participants. (IRB#: IRB_00177944)
Testing the Drug Iptacopan in People with Idiopathic Immune Complex Mediated Membraneoproliferative Glomerulonephritis
Idiopathic immune complex mediated membraneoproliferative glomerulonephritis (IC-MPGN) is a rare, severe disorder of excessive activation of the alternative complement pathway (AP). AP is an important part of immune system in the body which provides protection against infections. However, an over-activated AP is believed to contribute to several kidney diseases, including IC-MPGN. This study will test a drug called Iptacopan to treat adults with this disorder. The study wants to see if the drug will help people and is safe. People in the study will be randomly chosen to be treated with Iptacopan or a placebo. The placebo looks like the drug but does not have the medication. Being in the study requires about 15 study visits at the study clinic over 21 months. Medical tests will be done during the study to track the health of participants. (IRB#: IRB_00175737)
Testing the Drug JNT-517 in People with Phenylketonuria
Phenylketonuria (PKU) is a condition in which a persons body does not break down an amino acid called phenylalanine. People with PKU must follow a special diet limiting the amount of protein they eat. This study will test a drug called JNT-517 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 JNT-517 or a placebo. A placebo looks like the study drug but does not have the medicine. The drug and placebo are taken as a swallowed pill. Being in the study requires attending in person visits at the study clinic with an option for a couple home visits over about 9 to 13 weeks. Participants will keep a diet diary. Medical tests will be done during the study to track the health of participants. (IRB#: IRB_00185433)
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 Obefazimod for People with Moderate to Severe Active Crohn's Disease
Crohns disease (CD) is a lifelong condition that causes inflammation (pain, swelling) of the gastrointestinal tract (how the body digests food) due to an over-reaction of the immune system (the bodys defense system, which fights infection). The most common symptoms of CD include diarrhea, abdominal pain, weight loss, intestinal bleeding, and fatigue. This study will test a study drug called Obefazimod 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 Obefazimod or a placebo. A placebo looks like the study drug but does not have the study medication. Later in the study, participants will all receive the study drug. Being in the study requires at least 15 visits to the study clinic for over about 108 weeks. Medical tests will be done to track the health of participants. (IRB#: IRB_00182438)
Testing the Drug Pegunigalsidase Alfa for Children and Teenagers with Fabry Disease
Fabry disease is a rare genetic condition that keeps the body from breaking down certain fatty materials that build up in the body's cells. This can result in health issues such as pain in the hands and feet, damage to kidneys, brain and heart. This study will test a drug called Pegunigalsidase Alfa (Elfabrio) to treat children and teenagers with this disease. The drug has already been tested in adults with Fabry disease. The study wants to see if the drug will help children and teenagers with the disease and is safe. Participants will currently be in Stage I or Stage II of the study and be asked to continue participation. Participants who choose to continue will first attend in person visits for screening at the study clinic over about 6 weeks. Then if study criteria are met participants will attend in person visits at the study clinic for about 8 hours every two weeks to receive the study drug. Study participation will last up to 1 year. Medical tests will be done during the study to track the health of participants. (IRB#: IRB_00180688)
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 PTX-022 for People with Microcystic Lymphatic Malformations
Microcystic Lymphatic Malformations (mLM) is a rare disease of the lymphatic system characterized by abnormal vessels, outpouchings, or cysts filled with lymphatic fluid under the skin. The disease is usually present at birth and worsens overtime. This study will test a drug called PTX-022 to treat people with this disease. The study wants to see if the drug will help people with the disease and is safe. Participants will apply the study drug as a topical ointment on the area affected by mLM. Participants will share medical history, have a medical exam, complete interviews, have pictures taken of the area where the study drug was applied. Being in the study requires attending both in person visits at the study clinic and remote visits over about 168 days. Medical tests will be done during the study to track the health of participants. (IRB#: IRB_00188357)
Testing the Drug RAP-219 for People with Refractory Focal Epilepsy
Refractory Focal epilepsy is a disease that affects the brain and causes seizures. This study will test a drug called RAP-219 to treat 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 receive RAP-219, keep a daily diary, complete surveys, and other medical tests. Being in the study requires attending in person visits to the study clinic over 24 weeks. Medical tests will be done during the study to track the health of participants. (IRB#: IRB_00181216)
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 REGN7544 for People with Postural Orthostatic Tachycardia Syndrome
Postural Orthostatic Tachycardia Syndrome (POTS) is a condition that causes a serious increase of heart rate when standing up from sitting or lying down. This study will test a drug called REGN7544 to treat people with POTS. The study wants to see if the drug will help people with the condition and is safe. People in the study will be randomly chosen to be treated with the study drug REGN7544 or a placebo. The drug and placebo look the same, but the placebo does not have the medication. People in the study will wear a cardiac (heart) monitor on the chest. Being in the study requires up to 8 visits at the study clinic over about 18 weeks. Medical tests will be done during the study to track the health of participants. (IRB#: IRB_00184156)
Testing the Drug SAR447537 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 SAR447537 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 SAR447537. 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 SAR447537 or Zemaira. Other study visits will be required for medical tests to track the health of participants. (IRB#: IRB_00169660)
Testing the Drug SAR447537 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 SAR447537 (formally 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 who have recently finished the INBRX phase 2 study and would like to continue taking SAR447537 are invited to participate, as well as people who are new to this study. Being in the study requires attendance at the study center for up to 3 years every 3 weeks to receive treatment with SAR447537. Other study visits will be required for medical tests to track the health of participants. (IRB#: IRB_00179012)
Testing the Drug Tolvaptan for Infants and Children with Autosomal Recessive Polycystic Kidney Disease
Autosomal Recessive Polycystic Kidney Disease is a rare kidney disease that causes poor kidney function in infants and children. This study will test a drug called Tolvaptan to treat infants and children with this disease. The study wants to see if the drug helps infants and children with this disease and is safe. Infants and children in the study will participate in at least 11 in-person study visits at the clinic and 9 more visits have the option of home health visits. Participation lasts about 19 months. Medical tests will be done during the study to track the health of participants. (IRB#: IRB_00161351)
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 Vedolizumab Intravenous plus Adalimumab Subcutaneous or Ustekinumab in Adults with Moderate to Severe Crohn's Disease
Crohns disease (CD) can cause severe pain and swelling in the digestive tract of the stomach. This study will test combining the different approved CD drugs Vedolizumab Intravenous plus Adalimumab Subcutaneous or Ustekinumab to treat adults with this disease. The study wants to see if the combination of drugs will help people with the disease and is safe. People in this study will receive one of the combination treatments depending on the treatment received from previous routine medical care before participating in the study. After the combination treatment is given people will receive only Vedolizumab. Once all treatments are complete there will be a follow-up period. Being in the study requires attending in person visits at the study clinic and lasts about 1.5 years. Medical tests will be done during the study to track the health of participants. (IRB#: IRB_00184866)
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 Impact of Motor Adaptation for People with Concussions
This study wants to better understand how concussions impact peoples ability to change walking behavior in response to changes in the environment. People in the study will have brain activity and walking behavior measured while walking on a treadmill. Being in the study requires attending one visit to the study clinic lasting about 1.5 hours. This study will compare the motor adaptation of people who have concussions to healthy individuals. (IRB#: IRB_00189122)
Testing the REMI System for People with Seizure Events
The REMI is a type of sensor placed on a persons head to monitor brain activity. This study will test if the REMI system EEG data (the measure of electrical activity in the brain) can be used to identify ictal (seizure) events over time. A seizure is when uncontrolled electric activity in the brain causes uncontrolled body movements. The study wants to see if extended EEG data could help diagnose and treat seizure-related symptoms. Being in the study requires several in-person visits to a study clinic for about 1 month. This includes wearing the REMI system at home and completing surveys. Medical tests will be done during the study to track the health of participants. (IRB#: IRB_00171153)
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 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 Guselkumab to Treat Children with Juvenile Psoriatic Arthritis
Juvenile Psoriatic Arthritis (jPsA) is a condition that causes chronic joint pain and swelling along with red patches on the skin or a silvery-white buildup of dead skin. This study will test guselkumab to treat children with jPsA. The study wants to see if the drug will help people with the condition and is safe. Participants in the study will receive the study drug guselkumab. The drug is taken as a liquid shot under the skin. Being in the study requires attending in-person visits at the study clinic and lasts about 52 weeks. Medical tests will be done during the study to track the health of participants. (IRB#: IRB_00145602)
Testing the Study Drug INT-787 for Adults with Severe Alcohol-Associated Hepatitis
Severe Alcohol-Associated Hepatitis is inflammation and damage to the liver causing serious health issues such as scarring of the liver. This study will test a drug called INT-787 for people with this condition. The study wants to see if the drug will help people and is safe. People in this study will be randomly chosen to be treated with INT-787 or a placebo. The placebo looks like the study drug but does not have the treatment. People in the study will have an ultrasound. This is a small handheld device placed on the top of the skin to take an image. For this study, the image is of the stomach area. People will also have a CT scan of the stomach. This is to see the liver and gallbladder (an organ in the body that stores fluid for the liver). Participation requires attending in-person visits at the study clinic and lasts about 84 days. Medical tests will be done to track the health of participants. (IRB#: IRB_00176542)
Testing the Study Drug Lorundrostat for Adults with Hypertension
Hypertension is high blood pressure increasing the risk of serious issues such as heart failure or stroke. This study will test a drug called Lorundrostat for people with this condition. 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 Lorundrostat or a placebo. The placebo looks like the study drug but does not have the treatment. People in the study will take Lorundrostat in addition to continuing the high blood pressure medication from a previous study. Being in the study requires attending in-person visits at the study clinic. Participation lasts about 12-13 months. Medical tests will be done to track the health of participants. (IRB#: IRB_00168927)
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 Solrikitug for Adults with Eosinophilic Esophagitis
Eosinophilic Esophagitis (EoE) is when the esophagus (which connects the throat to the stomach) becomes inflamed, causing heartburn and swelling and making it hard to swallow. This study will test a study drug called Solrikitug to treat adults with EoE. The study wants to see if Solrikitug will help people with the disease and is safe. People in this study will be randomly chosen to be treated with Solrikitug or a placebo. A placebo looks like the study drug but does not have the study medicine. Being in the study requires attending up to 20 visits at the study clinic for about 72 weeks. Medical tests will be done during the study to track the health of participants. (IRB#: IRB_00182390)
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 Study Drug UCB0022 for People with Advanced Parkinsons Disease
Advanced Parkinsons Disease is nerve damage in the brain that affects a persons movement and balance. Advanced Parkinsons Disease is when the symptoms are disabling and affect daily life. This study will test a drug called UCB0022 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 UCB0022 or a placebo while on the standard of care. A placebo looks like the study drug but does not have the treatment. People in the study will use a tablet to complete surveys, wear a special watch, and keep a diary. Being in the study requires attending in-person visits at the study clinic. Participation lasts about 18 weeks. Medical tests will be done to track the health of participants. (IRB#: IRB_00172303)
Testing the Study Drug Vixarelimab for People with Moderate to Severe Ulcerative Colitis
Ulcerative colitis is a disease that affects the intestine (helps digest food). This study will test a drug called Vixarelimab for people with moderate to severe ulcerative colitis. The study wants to see if the drug will help people and is safe. People in this study will be randomly chosen to be treated at various time points with Vixarelimab or a placebo. The placebo looks like the study drug but does not have the treatment. The study drug and placebo are given under the skin. People in the study will have a colonoscopy or flexible sigmoidoscopy that is video recorded at screening, week 12, and at the end of the study to assess disease activity. People will use an electronic diary on a handheld device to record study activity. Participation requires attending in-person visits at the study clinic and lasts about 25 weeks or 61 weeks if participants choose to be in an optional study. People are paid for participation. Medical tests will be done to track the health of participants. (IRB#: IRB_00177806)
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 Unilateral Neglect from Stroke Using Prism Adaptation Treatment
A stroke is an attack on the brain when blood flow to the brain stops. The study will learn if there are patterns of damage to certain areas of the brain when people have different kinds of unilateral spatial neglect from stroke. This is when people struggle to see, feel, hear, and move the side of the body after a stroke. Prism Adaptation Treatment (PAT) is used to help people with unilateral spatial neglect. This study will see if there is a specific type of unilateral spatial neglect that will improve from the PAT. Being in the study requires completing tests on a computer and the PAT. This is done by wearing goggles with special lenses over the eyes while doing different tasks like reaching for objects or crossing out shapes on paper. Participants will attend in-person study visits that can occur during already scheduled therapy visits. Participation lasts about 3 weeks. People are paid for participation. (IRB#: IRB_00174433)
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 Effect of Planning to Balance During Walking, Stepping, or Jumping Interruptions
Research is needed to find how people balance during expected or unexpected walking, stepping, or jumping. interruptions. The information we learn will help us better understand how to support people with balancing challenges. (IRB#: IRB_00145032)
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 Timing of Eating Food and Sleep Loss on a Person's Health
Sleep is an important factor for overall health. This study will see how different light exposure patterns and food intake impact a persons metabolism (how the body breaks down food) when sleeping is reduced. People in the study will attend about 6 to 8 in-person visits to that study clinic, including some overnight stays. People will complete surveys and medical tests. The study will last about 4 to 6 months. People will be paid to complete the study. (IRB#: IRB_00185590)
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)
Tobacco cessation among tobacco and marijuana co-users
Tobacco is related to cancer risk. Most attempts to quit are unsuccessful. Many people who use tobacco also use marijuana. Using the two substances together may impact whether tobacco quit attempts are successful. This study will provide information about factors that influence the use of tobacco and marijuana. This information we learn may aid future patients who would like to quit using tobacco. (IRB#: IRB_00168877)
Top Performance in Residential Construction
This study wants to learn strategies that lead to top performance in residential (home) construction to prevent injuries and errors. Top performance will be assessed by residential construction workers doing various tasks such as climbing a ladder to reach a platform and hammering nails into a frame. People in the study will wear sensors that record body movements during the tasks. People will also complete a survey and participate in an interview. Being in the study requires attending a 2-hour in-person visit at the University of Utah. (IRB#: IRB_00179322)
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 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)
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)
Understanding Menopausal Symptoms
Menopause occurs as women age and affects womens health including sleep and mood disorders. This study wants to better understand the burden menopause has on women and sleep disorders. The study will help learn more about current treatments and how menopause is being addressed and controlled. People in the study will have routine care and medical treatment observed by the study. No changes to medical treatment or additional exams will occur. Being in the study requires sharing medical records and completing surveys monthly over 12 months. People will also write in a diary during the study. People are paid for participating in the study. (IRB#: IRB_00188204)
Understanding the questions parents have when they find out their child is a carrier of a genetic disease?
When parents receive a letter in the mail telling them that their child is a carrier of a disease, there can be significant distress and confusion. We would like to build a tool that guides parents to the information they need, when they need it. The purpose of this study is to discover what they really need to know so that we can build a tool that matches parent needs in the state. (IRB#: IRB_00179621)
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)
Using Light Therapy to Promote Brain Health in People with Moderate to Severe Brain Injury and Stroke
This study tests the effects of a specific light therapy called photobiomodulation (PBM) on brain health and resiliency for individuals experiencing moderate to severe traumatic brain injury (TBI) or stroke. PBM, also known as low-level light therapy, involves shining red or near-infrared light onto the head with a device. People in the study will first complete a pre-assessment, which includes several parts. This includes cognitive tests to assess memory, attention, and overall thinking abilities and surveys about any symptoms experienced and medical history. Participants will also have an MRI, a scan that takes pictures of your brain. After this, participants will learn how to use the light therapy device. Participants will then complete light therapy sessions at home for 12 weeks, tracking usage. Participants will return for a post-assessment at the end of the 12 weeks. This final assessment will be like the first, with cognitive tests, surveys, and another MRI. (IRB#: IRB_00163429)
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)
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)
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)
Vocal Heath of People who Perform Metal Music
This study wants to better understand the voice health of people who perform metal music. People in the study will complete a voice evaluation that takes up to 90 minutes. This provides knowing the overall vocal health. If people move on into the study after the evaluation, participants will complete two recording sessions. One session takes up to 2.5 hours. The other session takes about 2 hours. During the sessions participants will breathe, do throat muscle activities, and have an image of the throat taken while breathing, talking, and singing. (IRB#: IRB_00166105)
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)
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)