Search Criteria: Studies that include females;
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)
(SFCA) Microbial Metabolite Supplements on Eosinophilic Esophagitis Microbiome
The purpose of the study is to understand the impact of microbial metabolite supplements called short chain fatty acids (SCFA) on the microbiome and immune signatures in eosinophilic esophagitis. 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)
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 digital diabetes prevention program to improve health behaviors among custodial workers
The purpose of this study is to investigate whether a diabetes prevention program delivered via a smartphone app can change the exercise habits, dietary choices, and stress management strategies of custodial workers. This will also help design programs and inform policies to support you on campus. (IRB#: IRB_00197431)
A Financial Intervention for Dementia Family Caregivers in Early and Middle Adulthood
Caregivers who care for children, family, or friends with long-term health issues often face work, health, or financial problems. This study wants to better understand how to deliver a financial intervention for Dementia family caregivers in early and middle adulthood. People in the study will participate in a 30-to-45-minute interview on Zoom and complete a survey. Participants will then complete a 4-week intervention with 4 sessions on Zoom and 2 surveys. Participants will receive compensation for study completion. (IRB#: IRB_00185128)
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 Phase 1b/2 study testing the safety, efficacy and absorption of Blinatumomab, given as an injection under the skin (subcutaneous), in children under 12 years old who have Relapsed/Refractory and Minimal Residual Disease Positive (MRD+) B-ALL .
This study is testing a medicine called Blinatumomab, given as an injection under the skin (subcutaneous), in children under 12 years old who have leukemia. The main goals of the study are to check if the medicine is safe for young children. See how well it works to treat their leukemia. Understand how the medicine behaves in the body, how it is absorbed and processed. (IRB#: IRB_00193889)
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 on Latter-day Saint Beliefs and Goals
Anyone who identifies as a member of The Church of Jesus Christ of Latter-day Saints will complete a 15-minute online survey. 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. (IRB#: IRB_00184731)
A study testing the combination of dasatinib or imatinib to chemotherapy treatment with blinatumomab for children, adolescents, and young adults with Philadelphia chromosome positive (Ph+) or ABL-class Philadelphia chromosome-like (Ph-like) B-cell acute lymphoblastic leukemia (B-ALL)
The overall goal of this study is to determine the effects, good and/or bad, of a new treatment regimen that combines dasatinib or imatinib to chemotherapy with blinatumomab in patients with Ph+ and ABL-class Ph-like B-ALL. (IRB#: IRB_00191773)
A Study Testing Two Immunotherapy Drugs for Children and Young Adults with Relapsed Leukemia
This study is designed to find better ways to treat children and young adults (ages 1 to under 31) who have a type of blood cancer called B-cell acute lymphoblastic leukemia (B-ALL) that has come back after initial treatment. The study is testing whether adding a new medicine called nivolumab to an existing treatment called blinatumomab will help improve outcomes. (IRB#: IRB_00139680)
A Study to Evaluate the Safety and Effectiveness of Injectable Disc Cell Therapy for Patients Who Have Mild to Moderate Lumbar Disc Degeneration
The purpose of this research is to find out if the experimental drug, Injectable Disc Cell Therapy (IDCT), is safe and effective in treating symptomatic lumbar degenerative disc disease. (IRB#: IRB_00194600)
A Study to Investigate the Safety and Efficacy of Brepocitinib in Adults with Lichen Planopilaris
The purpose of this research study is to learn more about an investigational medicine called brepocitinib and how it may help treat lichen planopilaris (LPP). Brepocitinib is a study drug designed to reduce inflammation. This study will look at how safe the drug is, how well it works, and whether it helps lower the inflammation caused by LPP. In this study, some people will receive brepocitinib, and others will receive a placebo. A placebo looks just like the study drug but has no active medicine in it. Researchers will compare the two groups to see if people taking brepocitinib improve more than those taking the placebo. It is not yet known whether brepocitinib works better than a placebo for treating LPP. If people taking the study drug do better, it may be helpful for this disease in the future. If you join the study, you will take part in several procedures. These may include answering questions about your medical history, taking vital signs, filling out questionnaires, having a physical exam, getting an electrocardiogram (EKG), a chest Xray, photographs, blood tests, and pregnancy tests (if needed). About 340 people will take part in this study at around 120 locations worldwide. At the University of Utah, the goal is to enroll 5 participants. Your participation will last up to 60 weeks, which is a little more than one year. (IRB#: IRB_00197765)
A study to see how sleep apnea affects gene expression and function
Patients with obstructive sleep apnea or no sleep apnea will participate in this study. The purpose of this research is to learn more about low levels of oxygen in the body (hypoxia) so that better treatments can be made for people that have hypoxia-related problems like sleep apnea. If you participate, you will have 2 visits at the study center, and a blood sample will be taken at each of those visits. (IRB#: IRB_00190590)
A study to see if an investigational study drug, nerandomilast, helps people with SARD-ILD
The purpose of this study is to investigate whether a drug called nerandomilast works to help people with SARD-ILD improve their lung function. You will be in the study for about 7.5 months. During this time, you will visit the study site 8 times. (IRB#: IRB_00190779)
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 Using Risk Factors to Determine Treatment for Children With Favorable Histology Wilms Tumors (FHWT)
This phase III trial studies using risk factors in determining treatment for children with favorable tissue (histology) Wilms tumors (FHWT). Wilms Tumor is the most common type of kidney cancer in children, and FHWT is the most common subtype. Previous large clinical trials have established treatment plans that are likely to cure most children with FHWT, however some children still have their cancer come back (called relapse) and not all survive. Previous research has identified features of FHWT that are associated with higher or lower risks of relapse. The term "risk" refers to the chance of the cancer coming back after treatment. Using results of tumor histology tests, biology tests, and response to therapy may be able to improve treatment for children with FHWT. (IRB#: IRB_00189859)
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)
Aspirin for the Prevention of Recurrent Preterm Delivery
This research study is studying whether a higher dose of aspirin will do a better job of lowering the risk of having another preterm delivery or stillborn baby. We invite you to take part in this research study because in your most recent pregnancy, you delivered more than five weeks early (before 35 weeks). (IRB#: IRB_00190457)
ASPIRIN Trial
ASPIRIN: Comparative effectiveness of two aspirin doses for prevention of hypertensive disorders of pregnancy (HDP) (IRB#: IRB_00196168)
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)
Assessing Wilderness Therapy Program Years After Participation
This study will learn about the experiences of people who attended a wilderness therapy program as teenagers. The study wants to better understand the long-term effects of adolescent wilderness therapy program participation. Being in the study requires attending an online interview via Zoom. The interview will last up to 40 minutes. Participants will receive payment for study participation. (IRB#: IRB_00191543)
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)
Behavioral Treatment for Nightmares in People with Rapid Eye Movement Sleep Behavior Disorder
Rapid Eye Movement (REM) Sleep Behavior Disorder (RBD) is a condition where people physically act out their dreams during REM sleep. This study wants to learn whether a behavioral (non-medication) treatment can reduce nightmares in adults with the condition. People with RBD and their care partners (spouse or other family member living with them) will participate in the study. All participants will receive the treatment via videoconference and complete 2 assessments. Participants with RBD will attend 7 sessions, and their care partners will attend 2 of those sessions with them. Participants will receive compensation for completing study activities. (IRB#: IRB_00187090)
Brain and Muscle Function and Botox Injections in People with Voice Disorder Adductor Laryngeal Dystonia
Voice Disorder Adductor Laryngeal Dystonia (also known as spasmodic dysphonia) causes the muscles in the larynx (voice box) to spasm, resulting in the vocal cords closing too much. This creates voice issues. This study wants to learn the places in the brain that are affected by this voice disorder and by its standard treatment (Botox injections into the throat muscles). People in this study will have brain scans along with assessments of the voice muscles. Brain scans involve lying still in a scanner while resting and speaking, and 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. Participants with laryngeal dystonia will have up to 4 brain scans (2 of each kind) and 2 voice muscle assessments over 1 Botox cycle (about 3-4 months). Participants who are not treated with Botox will have brain and muscle assessments 1 time each. This study will also test 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 sessions along with home practice. (IRB#: IRB_00143531)
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 Using Opioids for Chronic Pain
People with chronic pain are often prescribed long-term opioid medication. This study will test how a non-invasive, brain stimulation using focused ultrasound 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 over about 7-8 weeks. Each visit varies in time ranging from about 1 to 4 hours. People in the study will have magnetic resonance imaging (MRI) to take brain images and study stimulation. Participants will receive $350 for full study completion or $15 per hour for incompletion of all study visits. (IRB#: IRB_00179276)
Brain Stimulation for People with Treatment-Resistant Depression
This study will test a new, non-invasive low risk method of brain stimulation for people with treatment-resistant depression. This study wants to test how an ultrasound will be used to reach a specific area of the brain and the immediate effects on a person's mood. The study wants to see if the ultrasound brain stimulation helps people with treatment-resistant depression. People in the study will complete surveys, experience brain stimulations, and magnetic resonance imaging (MRI) to scan the brain. Being in the study requires attending 10 visits to the study clinic over about 2 months, including visits with MRI scans. (IRB#: IRB_00148802)
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)
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)
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)
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)
Collecting Health Information of People with Pompe Disease
Pompe disease is a rare, genetic disorder where glycogen builds up in cells, damaging muscles and organs like the heart. It is caused by a lack of the enzyme acid alpha-glucosidase (GAA), which is needed to break down glycogen. Symptoms include rapid progressive weakness and an enlarged heart in infants, to slow-progressing muscle weakness and respiratory issues in older adults. This study will collect health information to learn how treatment affects them. People in the study will not receive medication. People will complete surveys once a year for 5 years. (IRB#: IRB_00187886)
Comparing a Catheter versus Wire-Guided Technique for Accessing a Person's Bile Duct
The bile duct is accessed through an opening called the ampulla during a procedure called an endoscopic retrograde cholangiopancreatography (ERCP). Two techniques used for accessing the bile duct include a wire-first technique and a catheter-first technique. The wire first technique is usually more commonly used in the United States. This study will compare the use of a catheter to first access the bile duct, rather than a wire, to see if it reduces the risk of complications from the ERCP procedure. People in the study will be randomly assigned to receive the wire-guided technique or the catheter-guided technique to gain access to the bile duct during the ERCP procedure. Being in the study from the time of the procedure lasts about 4 weeks. Participants will be contacted by phone after the procedure. (IRB#: IRB_00191443)
Comparing Ultra-Low Frequency Spinal Cord Stimulation to Conventional Medical Management for People with Chronic Low Back Pain
This study wants to see how well Ultra-Low Frequency therapy compares to Conventional Medical Management in participants with chronic low back pain. Participants will be randomly chosen to be treated with Ultra-Low Frequency therapy along with Conventional Medical Management or Conventional Medical Management alone. Being in the study requires attending up to 17 in-person visits at the study clinic over about 27 to 33 months. Medical tests will be done throughout the study to track the health of participants. (IRB#: IRB_00179202)
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)
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)
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)
Crohns Therapy During and After Pregnancy for Females with Inflammatory Bowel Disease
This study will test whether the rates of birth defects, miscarriages, premature births, and other outcomes in females with inflammatory bowel disease (IBD) taking azathioprine/6MP or biologic therapy are different from those among IBD-affected females not taking these medications. As many females receive these types of drugs during prime reproductive years, this information helps guide the therapy of those with Crohns Disease or Ulcerative Colitis who want to have children while receiving this therapy for the illness. People in the study who are pregnant with IBD will complete questionnaires during each trimester of pregnancy, at delivery, 4, 9, 12 months, and then once a year up to 18 years after the birth of the baby. Questionnaires will be done by telephone, online, or at a clinic visit. Medical records will be shared with the study team. (IRB#: IRB_00192870)
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)
Cycling Affects for People with Parkinson Disease
Parkinsons disease (PD) is a disorder of the central nervous system that affects body movement often including tremors. This study will test whether a short session of moderate-intensity cycling, done before or after a stepping exercise, helps people with Parkinson disease learn and retain stepping skills better. People in the study will randomized into three groups for people with PD. The effects of the different groups will be compared by those who do aerobic cycling before stepping practice, after stepping practice, or not at all. Being in the study requires attending 6 in person visits at the study clinic over 2 weeks. (IRB#: IRB_00187483)
Dating and Sexual Violence Screening at the University of Utah
This study will address the issue of dating and sexual violence among students at the University of Utah. The study wants to improve campus-based violence screening and support practices at the University of Utah. People in the study will participate in one 30- to 60-minute interview, either in person or via Zoom. Participants will share perceptions of campus dating and sexual violence, including how to improve the resources provided by the university. People will be paid for participation. (IRB#: IRB_00196127)
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 Nasoendoscopic Tremor Rating Assessment for People with Vocal Tremor
This study will validate a Nasoendoscopic exam assessment tool for rating tremor clinical features in the upper airway structures for people with vocal tremor. This study wants to develop valid and reliable clinical assessment tools for identifying vocal tremor affecting speech structures. Participants of the study will be experts in the fields of neurology, otolaryngology, and speech-language pathology. Being in the study requires attending two to four group sessions. Each session will last about 2 hours. Participants will provide feedback about the content and structure of a vocal tremor assessment tool. (IRB#: IRB_00187634)
Developing a Program for Couples Coping with Aphasia
Aphasia is a condition that can occur after a person has a stroke. Apashia is when a person is unable to communicate effectively. A program has already been created to support stroke recovery and improve the quality of life for couples. This study wants to create a new part of the program for couples where one partner has aphasia from a stroke. People in the study will complete a survey and attend three 90-minute group discussions. People will be paid for participation. (IRB#: IRB_00193407)
Developing and Testing an AI-Based Hybrid Chatbot for Financial Empowerment in Rural Cancer Care
This study will develop and test a new chatbot designed to help rural cancer patients and caregivers navigate the financial challenges of cancer care called SAFE.ai (Self-Advocacy for Financial Empowerment Assistant). A chatbot is a computer program that can engage in conversation with people. People in the study will attend 2 online sessions, including completing a survey, trying out two different versions of the chatbot. People will then share feedback on the usefulness, ease of use, and overall experience using the chatbot. All activities will be done online using a technology device such as a computer. Being in the study lasts about 2 weeks. Participants will be compensated for completing study activities. (IRB#: IRB_00193501)
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)
Dynamic Adult Flatfoot Morphology and Kinematics
This study is trying to learn more about how the feet and ankles work in adults who have flatfeet and those who do not. We want to understand how flatfeet caused by neurological conditions (like cerebral palsy) and flatfeet not caused by neurological issues affect a persons quality of life. We are looking for adults with and without cerebral palsy. You may also join if you have had foot surgery, have flatfeet, or do not have any foot problems. This study involves one visit that will take about 4 hours at the University of Utah Research Park. To join, you must be able to walk at least 10 meters (about 33 feet) with little or no help. Participants will receive compensation for taking part in the study. (IRB#: IRB_00142936)
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)
Electrical Stimulation of the Brain for People with Epilepsy
This study will learn more information about where seizures start, to improve epilepsy surgery, and how stimulation affects the brain in general. This study wants to develop a technique to identify the seizure onset zone in patients with medical refractory epilepsy (seizures not affected by medication). People in the study will be planning to have surgery for epilepsy. During the surgery electrodes will be placed onto the brain surface to help locate where the seizure starts. After the operation, people will be monitored in the intensive care unit for seizures. Near the end of this monitoring, people will undergo a stimulation mapping procedure to locate important areas of the brain that will be avoided during the second operation when brain tissue is removed or not. The procedures are part of the standard of care. In addition, low levels of stimulation to the electrodes on the surface of the brain will be done to record responses several times during the hospital stay. Participating in the study will not affect the outcome of the surgery or the length of hospital stay. (IRB#: IRB_00069440)
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)
Exercise and Brain Function
Exercise is known for helping a persons brain function. Research is needed to better understand how exercise may help improve the brain's learning and memory processes. The information we gain may aid future patients. (IRB#: IRB_00152596)
Expanding Web-Based Resources for People with Autosomal Recessive Polycystic Kidney Disease
Autosomal recessive polycystic kidney disease (ARPKD) is a rare inherited disorder. It is part of the Hepato/Renal fibrocystic disease group that affects the kidneys. The study will view past, current, and future medical information once given permission. The study wants to expand web-based resources so anyone can learn about ARPKD or other hepato/renal fibrocystic diseases. (IRB#: IRB_00124267)
Experiences in everyday driving conditions
We are studying the experiences of participants when they are driving in a simulator. Participants will be asked to complete a few surveys around the main driving task experience. Participants will also listen to short, recorded sentences as part of a secondary listening task. (IRB#: IRB_00198689)
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)
Family History of Pelvic Organ Prolapse
Pelvic organ prolapse occurs when the pelvic floor muscles in the body to become weakened, stretched, or damaged. This can cause pain in the pelvic area, bladder, or bowel issues. This study wants to identify and learn the possible genetic portions of pelvic organ prolapse (POP). People in the study will have a magnetic resonance imaging (MRI) scan to see the pelvic floor within the body. People will also have a pelvic exam to assess the pelvic floor and muscle strength. Being in the study requires 1 to 2 in-person visits to the study clinic, each lasting about 1 hour. People are paid for study participation. (IRB#: IRB_00181110)
Find your Flow Songwriting app!
Enjoy creating your own music on your phone or computer? Use songs to de-stress? Interested to try something new to work with your stress or anxiety? If so, this study is for you. "Flow" is a new creative songwriting tool that we are experimenting with on its possible benefits for stress and anxiety. The Arts & Health research team seeks participants who are interested in trying out the app by creating their own song and telling us what they think about it and if it helps in any way, especially with stress or anxiety. (IRB#: IRB_00197879)
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)
GLP-1RAs and Adult Metabolic Health
Semaglutide (known as Ozempic and Wegovy) and tirzepatide (Mounjaro and Zepbound) are type 2 diabetes and/or weight loss drugs. These drugs are 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 and tirzepatide. It is also unknown if certain people are more likely than others to regain weight if they stop taking semaglutide or tirzepatide. 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 and tirzepatide. Participants in the study will all use semaglutide or tirzepatide 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)
Growth and Development of Flatfoot in Kids and Teens with Advanced Imaging Methods
Flatfoot, or planus deformity, affects the function and movement of the foot and ankle. This can cause pain or discomfort while doing activities. Flatfoot is seen in children and teenagers with neurologic conditions such as Cerebral Palsy. Flatfoot is also seen on its own without any neurologic involvement or symptoms. Neurologic conditions concern the nervous system, which includes the brain, spinal cord, and all nerves in the body. This study wants to learn the changes in flat feet and the bone shape of feet as children and teenagers grow. People in the study will have a special CT (computer tomography) scan done to take pictures of the bones in a standing position. Special cameras and reflective stickers will also be used to learn more about how children and teenagers walk. The scans and tests will be done once a year for 3 years in a row. (IRB#: IRB_00190439)
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 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)
How the Community Thinks About and Votes on Social and Safety Issues
This study looks at how people vote on social issues and national security issues. You will take an online survey that takes about 15 minutes to finish. (IRB#: IRB_00199586)
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 Corneal Ulcer Outcomes
Undiagnosed corneal infection leads to blindness. Research is needed to develop a new testing method for finding types of corneal ulcers to stop the risk of blindness. The information we gain may aid future patients. (IRB#: IRB_00155406)
Improving Dementia Care with Hispanic/Latino Communities
Dementia is a disease that affects a persons memory, behavior, and movement. This study will co-design a Spanish-language advanced care planning (ACP) intervention for Hispanic/Latino people living with dementia and their care partners. The study will then test the impact of the intervention on Spanish-speaking Hispanic/Latino people living with Alzheimer's disease or related dementias. The participants who co-design the intervention will meet in groups on Zoom (a way to meet using technology such as a computer). Being in this part of the study requires meeting about 8 times over about 3 years. The study will then test the co-designed Spanish/Latino Alzheimer's disease or related dementia intervention with the specific population. (IRB#: IRB_00177351)
Improving Health Insurance Literacy for Young Adult Cancer Survivors
Health insurance can be difficult for young adults with cancer to find answers to questions about their health insurance plan. This studys purpose is to help young adult cancer survivors understand their health insurance and costs. People in this study are required to complete 3 online surveys over 12 months. Each survey will take about 20 minutes. Participants will be paid for completing each activity. Some participants will receive a digital informational booklet about health insurance while other participants will receive this booklet and also complete 4 health insurance support sessions with a navigator. Sessions will be completed on Zoom and last about 45 minutes. (IRB#: IRB_00164028)
Improving Hearing for People with Cochlear Implants
This study wants to better understand how adults with cochlear implants benefit from fine timing details in sound to support everyday listening. The study will measure hearing ability not only through listening tests, but also by tracking eye movements. Participants in the study will sit in a quiet room, listen to sounds played through speakers, headphones, and a computer. People will also listen to sounds in more natural environments. Being in the study lasts about 2 to 8 hours per session and requires 1 to 5 sessions over several days. People will be paid for being in the study. (IRB#: IRB_00194529)
Improving Human Movement with Wearable Devices
This study will learn how to design wearable devices and mobile sensors to measure human movement in the real world. This will help improve movement for people with conditions like stroke, osteoarthritis, and neuromuscular diseases such as Muscular Dystrophy (MS). People in the study will perform activities of daily living such as walking, walking on a treadmill, reaching, and squatting. The study will collect information about performing the activities with specific methods such as video recording or wearable devices. Being in the study requires completing up to 5 visits at the study clinic with each visit lasting 1 to 4 hours. (IRB#: IRB_00186623)
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 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)
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)
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)
Latter-day Saint and Utah Dwelling Family Caregivers
Family caregivers provide important support for people with chronic illnesses and disabilities. Faith communities can be an important source of support for these caregivers. This study wants to learn about the context of the Latter-day Saints faith community and living in Utah for family caregivers. People in this study will complete a survey and a one-time 30-to-45-minute interview or one-time 60-to-75-minute group discussion using a technology device such as a computer over Zoom. Participants will receive a $50 gift card for completing the study. (IRB#: IRB_00188500)
Learn To Teach Your Child With Autism How To Swim
This study will develop and test a swim lesson training program for parents to teach their children diagnosed with Autism Spectrum Disorder how to swim. Being in the study requires the parent and child to attend an initial 30-minute swim session at the participants nearest swimming pool that also includes parent training. Then the parent and child will attend eight 15-minute swim lessons twice a week for four weeks using strategies learned from the researcher to help the parent teach the child how to swim. During the four weeks, there will also be 30-minute Zoom meetings with the researcher once a week. There will be two 30-minute follow-up visits at months three and six, like the initial session. Study participation lasts about 5.5 hours over 6 months. (IRB#: IRB_00188978)
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)
Light Therapy for People with Concussion and/or Mild Traumatic Brain Injury
People with concussions or Traumatic Brain Injury (TBI) may continue to experience long-term symptoms, such as difficulties with thinking, physical discomfort, or emotional challenges. Light therapy is a non-invasive treatment option that may help improve these symptoms. This study will test Red Light therapy devices to treat people with concussions or TBI. The study wants to see if the therapy will help people with ongoing symptoms and is safe. People in the study will be placed in one of two groups. One group will use an active Red Light therapy device while another group uses an inactive device. People will learn how to use the device at home to record usage. After the study ends people in the inactive device group will have the option to participate with the active device for another 15 weeks. People in the study will complete surveys, cognitive and motor skills tests, and an MRI (brain scan). Being in the study requires attending 4 in person visits at the study clinic and lasts 15 weeks. (IRB#: IRB_00182200)
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)
Long-term study of foot and ankle anatomy in children and teens with Charcot-Marie-Tooth Disease
CharcotMarieTooth (CMT) disease can affect how the feet and ankles grow and move. This study looks at how the bones and muscles in the feet and ankles change over time in children and teens with CMT. What we learn may help improve future treatments. The study includes three visits over two years. Children and teens with and without CMT will have medical imaging to take pictures of their feet and ankles. Those with CMT will also have genetic testing and simple tests of muscle strength, hand use, and walking. The movement tests will be repeated after one year and after two years. (IRB#: IRB_00195630)
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)
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)
Memory and the Aging Brain
The purpose of this study is to examine age-related changes in attention and memory, whether these changes can be explained by changes in the brain, and how certain health variables contribute to changes in memory and the brain. (IRB#: IRB_00194069)
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)
Migraines and Headaches
Migraines and headaches are one of the most common pain people experience. Research is needed to better understand migraines and headaches. Including the pain, they may cause and quality of life. The information we gain may aid future patients. (IRB#: IRB_00185165)
MilkMetrics: Evaluation of a low-cost, wearable device for measuring lactation
The purpose of this study is to test the ability of certain wearable flexible sensors to quantify the amount of milk expressed by breastfeeding mothers (IRB#: IRB_00194627)
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)
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)
Motivation for People to Quit Smoking
This study wants to learn what motivates people who smoke to try quitting. The study wants to understand how certain factors, such as emotions and stress, make people feel motivated to quit smoking and whether they try quitting. Participants will come to a virtual visit to learn about the study. If they agree to participate, they be texted a survey that takes approximately 20-40 minutes to complete. Participation also requires answering a 3-minute survey on the smartphone app 2 times per day for 28 days. Being in the study will last about 1 month. The surveys will ask participants about feelings, experiences, emotions, smoking, and whether they tried to quit that day. (IRB#: IRB_00190436)
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 four in-person visits at the study clinic over two weeks (4h in total across all visits). (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)
Navigating Gender-Affirming Care for Transgender Communities
This study wants to better understand the experiences of transgender and gender-diverse people and their loved ones when accessing gender-affirming care. Being in the study requires attending a group discussion held virtually online for about 90 minutes. People will be paid for participation. The information learned will help identify challenges people face in getting care, the medical and social needs that are not being met, and how Utah's current cultural climate influences decisions about medical care. The study will help improve healthcare services and support for transgender and gender-diverse individuals and their families. (IRB#: IRB_00185998)
NERVE TRANSFERS TO IMPROVE UPPER EXTREMITY FUNCTION AND QUALITY OF LIFE IN TETRAPLEGIC PATIENTS
The purpose of this study is to gather information about the treatment of Spinal Cord Injury (SCI) through the use of a surgical procedure known as a nerve transfer. SCI is a devastating condition which is thought to affect nearly 40 cases per million persons annually in the US. More than 50% SCI occur in the cervical spine (i.e., tetraplegia), resulting in some loss of arm and/or hand function. Nerve transfers are used to improve upper extremity and hand function in patients who have suffered from SCI. This is a treatment option that is available to all (appropriate) patients, and participation in this study is not necessary to receive this treatment. Participation in this study is voluntary, and is available only to those who meet certain eligibility criteria. These criteria will be reviewed on a case by case basis by the University of Utah Department of Neurosurgery's study team as potential participants express their interest in the study. Various appointments and/or diagnostic procedures may be scheduled in order to ensure the eligibility of potential patients. There is no financial cost to patients (aside from the standard costs of care) who participate in this study, and there are no direct financial benefits provided for doing so. Participants will be followed after the procedure both by the surgeon and the physical therapy team. This study does provide funding for the physical therapy services utilized in the long-term follow up phase, but this funding is limited. So participants are encouraged to schedule these visits appropriately. The information provided on this page is not exhaustive, so those who are interested in this study are encouraged to contact our study team to discuss any questions they might have. You can do this by contacting the study coordinator, Kirby Taylor, via telephone or email. (IRB#: IRB_00126462)
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)
Non-Invasive Brain Stimulation for People with Fibromyalgia Pain
Fibromyalgia is a chronic condition that causes widespread muscle pain throughout the body. This study will test a new, non-invasive brain stimulation using focused ultrasound. The study wants to see if this brain stimulation helps people with fibromyalgia pain. People in the study will be randomly chosen to receive the focused ultrasound treatment or a placebo. A placebo appears to be like the treatment but is inactive. People in the study will have magnetic resonance imaging (MRI) to take an image of the brain, complete surveys, and medical tests. Being in the study requires both in-person and virtual visits over about 18 weeks. The total time commitment is about 15 hours. (IRB#: IRB_00193109)
Observing Patients with Pulmonary Hypertension Associated with Interstitial Lung Disease
This study will collect data from patients with Pulmonary Hypertension associated with Interstitial Lung Disease (PH-ILD) to better understand the disease and the effects of treprostinil treatment. People in the study will be in one of three groups. One group will not be receiving the treatment. One group will have initiated treatment within the previous 60 days before participation. Another group will already be receiving the treatment and have been taking it for more than 60 days. People in the study will have data collected at the beginning of the study. At a one-time 3-month check-in, and every 6 months for 5 years. (IRB#: IRB_00190017)
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)
Physical Inactivity and Muscle Health Recovery
Times of physical inactivity such as illness, recovery from surgery, or injury in older adults and those who are overweight may harm muscle health. Research is needed to learn how different markers such as hormones and proteins in the blood and muscle respond to physical activity and recovery. The information we gain may allow us to better design ways to help muscle health when older adults or those who are overweight become physically inactive and have rehabilitation. (IRB#: IRB_00130232)
Platelet Rich Plasma (PRP) for the Treatment of People with Musculoskeletal Conditions
This study will see the impact of pain and physical function after a Platelet Rich Plasma (PRP) treatment in people with musculoskeletal issues. PRP is a treatment derived from a persons own blood and has gained attention for its potential to improve pain and function in musculoskeletal conditions. People in the study will attend one in-person visit at the study clinic for the PRP injection and then have five follow-up events via email and/or telephone over about 12 months to complete surveys. (IRB#: IRB_00191115)
Post-marketing Study to Evaluate the Efficacy and Safety of an Omicron JN.1 Subvariant SARS-CoV-2 rS Vaccine Adjuvanted with Matrix-M® in Adults 50 to < 65 Years of Age Without High-risk Conditions for Severe COVID-19
This research study is being conducted to see if the study vaccine (NVX-CoV2705) prevents COVID-19 and to provide additional information on the safety of the study vaccine in adults 50 to 64 years old who do not have an underlying condition that puts them at high risk for severe outcomes from COVID-19. (IRB#: IRB_00200364)
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)
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)
Prospective Treatment of Types I, II and III Pleuropulmonary Blastoma (PPB) A COG Groupwide Phase 3 Study
This phase III trial tests how well surgery plus chemotherapy compared to surgery alone works in treating patients with type I pleuropulmonary blastoma (PPB), and tests how well surgery plus standard chemotherapy with the addition of topotecan works compared to surgery plus standard chemotherapy alone in treating patients with type II and III PPB. Historically, most children with type I PPB had surgery and approximately 40% of children with type I PPB received chemotherapy following their surgery, usually for 22-42 weeks. There has not been a consistent standard for which children with type I PPB receive chemotherapy after surgery. For patients whose tumor has been removed completely with surgery, observation without chemotherapy may work as well as giving chemotherapy after surgery in preventing a return of the PPB tumor. The standard chemotherapy for patients with types II or III PPB in the United States is four cycles of IVADo (ifosfamide, vincristine, dactinomycin, and doxorubicin) followed by 8 cycles of IVA (ifosfamide, vincristine and dactinomycin). Ifosfamide is in a class of medications called alkylating agents. It works by slowing or stopping the growth of tumor cells in the body. Vincristine is in a class of medications called vinca alkaloids. It works by stopping tumor cells from growing and dividing and may kill them. Dactinomycin is a type of antibiotic that is only used in cancer chemotherapy (antineoplastic antibiotic). It works by damaging the cell's deoxyribonucleic acid (DNA) and may kill tumor cells. Doxorubicin is in a class of medications called anthracyclines. Doxorubicin damages the cell's DNA and may kill tumor cells. It also blocks a certain enzyme needed for cell division and DNA repair. Topotecan is in a class of medications called topoisomerase I inhibitors. It works by interfering with tumor cell DNA which kills them. Giving topotecan in addition to standard IVADo and IVA chemotherapy regimens may shrink the cancer as well as or better than the standard therapy or could decrease the chance the tumor spreads while causing fewer side effects. (IRB#: IRB_00189967)
Providing Feedback About Online Visits for Menopause
Menopause occurs as women age and affects women in various ways, including hot flashes, sleep, and mood disorders. Many women would like education about this life transition. Women also would like access to both pharmaceutical treatments, such as menopause hormone therapy, non-hormonal medications, and non-pharmaceutical treatments such as mindfulness and herbal medicine. This study will create and evaluate a telehealth platform for group menopause care. People in the study will provide input about the telehealth platform. No medical treatment or care will be provided. Being in the study requires providing input and completing surveys over one or more 90-minute sessions to discuss the telehealth platform. People are paid for participating in the study. (IRB#: IRB_00193608)
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)
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)
Red Light Therapy for People who are Veterans
This study will see the impact of a specific light therapy called photobiomodulation (PBM) on brain health and resiliency, cognitive and behavioral performance, and psychological health in Veterans who have also received treatment at the Veterans Affairs (VA) Hospital. People in the study will receive either a sham or an active treatment headset. A sham headset is physically identical to the active headset but does not provide any light therapy. Being in the study requires a pre-treatment assessment that takes approximately 4.5 hours, eight weeks of at-home treatment that are 20-minute treatment sessions, 5-6 times per week, and a post-treatment assessment that lasts about 4.5 hours. During the pre-and post-treatment sessions, information will be collected about thinking ability, behavior, general mood, and motor function to see the impact of the light therapy. People will also have magnetic resonance imaging (MRI) to help see the inside of the brain to understand if changes occur related to any improvements in thinking or mood. (IRB#: IRB_00168602)
Reducing Nightmares for Adults with Narcolepsy
Narcolepsy is a sleep disorder that causes severe drowsiness. This study wants to learn whether a behavioral (non-medication) treatment can reduce nightmares in adults with narcolepsy. All participants will receive the treatment and will complete three assessments. Half of the participants will receive the treatment after the first assessment, and half will receive it after the second assessment. Being in the study requires attending 7 treatment sessions over 20 weeks. Participants will receive compensation for completing study activities. (IRB#: IRB_00188162)
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 bowel symptoms and diet in patients with irritable bowel syndrome (IBS) and inflammatory bowel disease (IBD)
Irritable bowel syndrome (IBS) and inflammatory bowel disease (IBD) are two different health conditions, but they can cause many of the same stomach and bowel problems. The goal of this study is to find out how common these symptoms are in people with IBS and IBD, and how these symptoms may be connected to what people eat. We will also look at how symptoms and eating habits are different between people who have IBS and people who have IBD. (IRB#: IRB_00192369)
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)
Responsibly Co-designing with Higher Education Faculty using Matchmaking for AI
Many college instructors and teaching assistants face increasing workloads. This study examines how artificial intelligence (AI) can helpwhen it is designed and used responsibly. We will work directly with faculty to codesign AI tools that meet their needs, using a collaborative method called Matchmaking for AI to identify both appropriate and inappropriate uses. Our goal is to ensure that AI in higher education is effective, ethical, and shaped by educators themselves. (IRB#: IRB_00196864)
Revaccination in Subsequent Pregnancies with RSV Vaccine and Duration of Protection
Respiratory Syncytial (sin-SISH-uhl) Virus, or RSV, is the leading cause of lower respiratory tract illness in babies and young children. RSVpreF is an approved vaccine to protect people and babies against RSV disease. When RSVpreF is given to pregnant women, it helps protect their babies against RSV disease in the first 6 months of life. It is unknown how long the protection will last from a single dose of RSVpreF. This study will test whether a second dose of RSVpreF when given in subsequent pregnancies is safe and can help produce antibodies that may protect the baby against RSV disease. Information will also be collected to learn whether a person still has antibodies from the past dose of RSVpreF given during the prior pregnancy. People in the study will be pregnant with unborn babies and non-pregnant. People will be divided into groups. One group gets one dose of RSVpreF. Another group will get either 1 does of RSVpreF or a placebo. A placebo looks like the drug but does not have the medication. Being in the study requires attending about 5 in person visits at the study clinic over up to 10 months. Medical tests will be done to track the health of participants. (IRB#: IRB_00189564)
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)
SHAM-PAIN Trial: Knee Artery Embolization to Reduce Pain in those who have Osteoarthritis
The main goal of this study is to see if we can sign people up and place them into either the real Genicular Artery Embolization (GAE) procedure or the sham (pretend) procedure. We also want to see how their knee pain changes over time. We will compare pain levels between the people who get the real GAE procedure and the people who get the sham one. We will check their pain every 3 months for up to 12 months. In this study, we use a procedure called embolization, which uses Xrays. There is also a sham procedure, which is a pretend version. During the sham procedure, the doctor does all the same steps as the real procedure, but does not block any blood flow. Only Dr. Ahmed and the study statisticians will know whether you get the real GAE procedure or the sham one. You will not know. A computer will choose which one you get at random, like flipping a coin. This helps the researchers see if GAE works better than a placebo (a fake treatment). If you are chosen for the sham procedure, you can get the real GAE procedure after 3 months at no additional cost. This section gives you the most important information to help you decide if you want to join the study. More details are included later. You can ask the research team any questions you have. If you have questions later, you can contact the study doctor using the information listed above. (IRB#: IRB_00196043)
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)
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)
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)
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 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 Lebrikizumab Treatment for People with Moderate-to-Severe Atopic Dermatitis
Atopic dermatitis (eczema) is a chronic skin condition that may cause itchy, red, dry patches of sensitive skin. Lebrikizumab is a drug used to treat people with this condition. This study wants to see how well the drug works to help adults and children with the condition. Being in the study requires attending 6 visits to the study clinic for about 2 years. Medical information will be collected during the study to track the health of participants. (IRB#: IRB_00187094)
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 People with Neurodiversity in Meetings
This study will learn more about how adults with neurodivergent traits experience virtual workplace meetings. People in the study will complete a one-time online survey, lasting 10 to 15 minutes, about virtual meeting experiences, including participation, managing interactions, feelings after meetings, and views on meeting quality and support for participation. (IRB#: IRB_00196654)
Studying the Genetic Factors in Smoking-Induced Vascular Disease
Genetic factors play a critical role, with studies showing that specific genetic variants may increase smoking-related cardiovascular (heart and blood vessel) disease. This study will determine whether people with specific genetic variants have a higher risk of smoking-induced vascular disease. The study will educate people carrying the genetic variants to stop smoking and provide potential treatments against smoking-induced vascular disease. People in the study will have medical tests during the study to collect genetic information related to genetic factors and vascular health. Being in the study lasts about 35 minutes over 6 months. People will receive payment for participation. (IRB#: IRB_00167355)
Studying the Impact of Treatments for People with Carotid Artery Disease
Carotid Artery Stenosis (CAS) is a condition that becomes more common as people age and can increase the risk of strokes. To prevent strokes in patients with CAS, doctors use several treatment options. These include medications to reduce stroke risk, surgery to remove blockages (called carotid endarterectomy), and newer methods such as TransCarotid Artery Revascularization (TCAR), which are safer for older patients. This study wants to learn the impact of treatments for CAS on cognitive and overall health in older adults. Participants in the study will complete a total of six surveys, three at the beginning of the study and then three six months later. The surveys will be given in person with the vascular surgeon, either on paper, an iPad, or a personal smartphone. (IRB#: IRB_00182594)
Studying Tissue of People with Epilepsy and facial pain
Epilepsy is a disorder in the brain that causes seizures. This study aims to identify chemical markers in the tissue of people with Epilepsy and trigeminal neuralgia. 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)
Support for Workers Caring for Someone with Dementia
The goal of this study is to learn what kinds of support working family caregivers need when they care for someone with dementia. We want to hear from people who work full time and earn $20 or less per hour, and who also help care for a family member with dementia. (IRB#: IRB_00197242)
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 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 New Psychological Intervention for People with Fibromyalgia in Lupus
Lupus is a serious and lifelong illness, causing flare-ups and damage to organs. It leads to a higher risk of death and a lower quality of life. Difficult life experiences, such as trauma or childhood adversity, are more common in people with lupus and fibromyalgia. These early experiences also raise the risk of anxiety, depression, and developing lupus later in life. This study will test a new therapy known as Emotional Awareness and Expression Therapy (EAET). EAET helps people understand and express emotions related to difficult past experiences, which may reduce physical pain and improve overall health. This study wants to see if EAET will help people with lupus who also suffer from chronic widespread pain (or fibromyalgia) and is safe. People in the study will be randomly chosen to receive the EAET therapy through telehealth or be on a waiting list. The study will see if the therapy helps reduce lupus flares, pain, fatigue, anxiety, depression, and improve quality of life and sleep. The EAET group will attend 8 two-hour group therapy sessions online once a week for 8 weeks. This group will also complete homework for about 30 minutes a day during participation. The wait list group will wait for 8 weeks until the EAET group is done. Both groups will complete surveys. The wait list group can choose to participate in the next therapy group session. (IRB#: IRB_00194480)
Testing a Non-Invasive, Magnetic Resonance Guided Focused Ultrasound System to Treat the Spine
This study will test an investigational device (not yet approved by the Federal Drug Administration) called Magnetic Resonance Imaging-guided Focused Ultrasound (MRgFUS) to develop a new non-invasive treatment for spinal pain. The device allows targeting very small volumes of tissue inside the body without affecting any other part of the body. This new device may one day offer patients an alternative therapy to surgical or more invasive treatments and reduce the amount of pain medications needed. People in the study will have a magnetic resonance imaging (MRI) exam similar to a routine MRI scan to take an image of the spine. Being in the study requires attending one in-person visit at the study clinic for up to 1 hour. People will receive payment for participation. (IRB#: IRB_00137036)
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 TAK-755 for People with Idiopathic Thrombocytopenic Purpura (iTTP)
Idiopathic Thrombocytopenic Purpura (iTTP) is a blood disease that leads to organ failure in the body. The study will test a drug called TAK-755 to treat adults with this disease. The study mainly wants to see if the drug will help people with this disease and is safe. People in the study will be randomly chosen to be treated with a different dose strength of the study drug TAK-755. Being in the study requires attending a various number of study visits at the clinic depending on the phase of study participation. Medical tests will be done during the study to track the health of the participants. (IRB#: IRB_00169901)
Testing a Study Drug Upadacitinib for Adults and Adolescents with Abbvie Hidradenitis Suppurativa
Abbvie Hidradenitis Suppurativa is a chronic (continues over time) painful skin condition that occurs in the places where the skin folds on the body. This study will test Upadacitinib to treat adults and adolescents with this disease. The study wants to see if the drug will help people with the disease and is safe. People in the study will be randomly chosen to be treated with Upadacitinib or a placebo. The placebo looks like the drug but does not have the medication. The drug and placebo are taken as a swallowed pill. During the study some participants may switch from taking Upadacitinib or the placebo. Being in the study requires multiple ways of participation such as writing in a journal at home and attending in person at a study clinic for about 2 years. Medical tests will be done during the study to track the health of participants. After the first 2 years of the study there is a chance for continued treatment until either (i) the Upadacitinib is approved by the regulatory authority and the individual in the study has reasonable access to it (such as through insurance or your local health system) or (ii) up until approximately Week 260 (3 additional years), whichever happens first. (IRB#: IRB_00168703)
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 45-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 a Weight Loss Program
People who log what they eat and weigh regularly tend to lose more weight and keep it off. This study wants to see if providing personalized payments for losing weight and logging food in an app motivates people to do these things regularly, while receiving weight management instruction from a registered dietitian. People in the study will complete surveys and weigh themselves at least 2 days a week on a provided scale. People will track what they eat and drink using a Fitbit app at least 5 days a week for 4 weeks. Once this phase is completed, people will attend 13 one-hour weight loss group classes, review videos on their own, and complete 2 virtual visits over 6 months, while continuing to weigh regularly and log food. People will also receive 3 to 5 text messages per week with study information. (IRB#: IRB_00188990)
Testing a Weight Maintenance Intervention
This study will test how effective a weight maintenance intervention is delivered through primary care. The study will compare an Electronic Health Recordbased coaching weight maintenance to a tracking-only intervention. The study information learned will help design, modify, and implement the intervention. People in the study will participate in a focus group that lasts about 1.5 hours. People will receive payment for participation. (IRB#: IRB_00194254)
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 AI-Assisted ECG Model to Help Diagnose Pulmonary Hypertension in People with Interstitial Lung Disease
This study will test a new tool to help improve early detection of pulmonary hypertension (PH) in people with interstitial lung disease (ILD). Pulmonary hypertension is high blood pressure in the pulmonary artery (which carries blood from your heart to your lungs). PH can go undiagnosed for many years, even after symptoms start, especially in people who suffer from conditions with similar symptoms (like ILD). The tool being tested looks like an electrocardiogram (ECG) to identify patients who are at high risk for having undiagnosed PH. The study also hopes this tool will help people with similar medical conditions in the future. People in the study will be randomly assigned to one of two groups. People will have an ECG at the initial study visit. People will complete surveys and have other medical tests. Medical information will also be used from the participants electronic health records. Being in the study requires attending in-person visits at the study clinic. Study participation lasts about 6 months. Participants will be paid for the time spent in the study. (IRB#: IRB_00189992)
Testing an Approach to Long-Term Weight Loss Success
This study will test an intervention for weight loss maintenance. People in the study will complete assessments and surveys measuring body weight, dietary intake, mental health, and physical activity. Being in the study requires participating in a 26-week intervention. This includes regular educational texts/emails, weekly online survey check-ins, weekly remote weigh-ins, and at least 4 in-person visits to the study clinic. Some participants may receive health coaching during parts of the study. (IRB#: IRB_00188310)
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, blood and sweat collection, and cognitive testing (how a person thinks), and complete a brain scan. Participant information will be collected that could relate to the brain such as age, gender, handedness, medical history, and tests about how people think. (IRB#: IRB_00157573)
Testing Combining Brain, Nerve, and Hand Stimulation for Hand Recovery of People After Stroke
A stroke causes damage to the brain and can affect mobility on one side of the body. This study will test how combining brain, hand, and nerve stimulation (activity) affects hand movement in people who had a stroke. People in the study will be interviewed and complete medical tests to measure brain, hand, and nerve responses. Being in the study requires attending in-person visits at the study clinic for about 3 to 18 sessions. (IRB#: IRB_00179089)
Testing Continuous Positive Airway Pressure for Sleep Apnea in Pregnancy
This study is testing whether obstructive sleep apnea (OSA) with continuous positive airway pressure (CPAP) in pregnancy reduces the rate of hypertensive (high blood pressure) disorders in pregnancy. The study will also test whether OSA with CPAP reduces other health risks related to pregnancy. People in the study will be randomly chosen to be placed into two groups. One group will receive weekly contact, incentives for following study procedures, and initial sleep hygiene (healthy sleeping habits) counseling. The other group will only receive initial hygiene sleep counseling. Participants will use a CPAP device to measure positive airway pressure when sleeping. Being in the study requires attending in-person visits at the study clinic with an option to attend telehealth for some visits. Participation lasts about 26 to 30 weeks. (IRB#: IRB_00110528)
Testing Drug MTX-463 for Adults with Idiopathic Pulmonary Fibrosis
Idiopathic Pulmonary Fibrosis is a condition that causes the lungs to scar and harden over time. This study will test a drug called MTX-463 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 receive MTX-463 or a placebo. A placebo looks like the study drug but does not have the medication. The drug and placebo are both given through a vein in the arm. Being in the study requires attending about 9 in-person visits to the study clinic over 32 weeks. Medical tests will be done during the study to track the health of participants. People will be paid for study participation. (IRB#: IRB_00191647)
Testing Educational Interventions at a University-Based Training Clinic
This study will test educational interventions (academic, behavioral, emotional, and social) within the University of Utah Educational Assessment and Student Support Clinic. The study wants to see the impact of the offered evidence-based educational interventions. Evidence-based interventions used will be determined by the client and family's referral concern. Interventions may include individual, group, and caregiver. People in the study will attend intervention sessions. Being in the study requires about 1 to 2 one-hour sessions a week over 8 to 12 weeks. Telehealth may be an option for participation. (IRB#: IRB_00184674)
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 Movement for Workplace Safety
This study will test the effects of safety equipment on an individual's movement while performing common construction-related tasks. The study wants to improve workplace safety in the construction industry. Participants will complete a series of tasks with different types of safety equipment. Body movements will be recorded during the tasks. Participants will also complete health and safety surveys. The study requires one 2-hour visit to the study clinic. (IRB#: IRB_00198176)
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 New Tools for Measuring Human Movement
This study will test how to better measure and track human movement during daily mobility tasks. People in the study will perform simple tasks, including walking, standing, climbing stairs or a ladder, and reaching with their arms. Motion will be tracked using different motion capture technologies, so videos will be recorded during the study. People may wear small markers and sensors on the body to track movement and muscle activity. Being in the study requires attending one in-person study visit at the clinic for about 2 hours. (IRB#: IRB_00196293)
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 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 Cell Therapy CABA-201 for People with Active Idiopathic Inflammatory Myopathy or Active Juvenile Idiopathic Inflammatory Myopathy
Idiopathic Inflammatory Myopathies (IIM) and Juvenile Idiopathic Inflammatory Myopathy (JIIM) are a group of rare autoimmune diseases characterized by inflammation and muscle weakness. This study will test a cell therapy, CABA-201, to treat people with IIM and JIIM. The study wants to see if the therapy will help people with the diseases and is safe. People in the study will receive CABA-201 in combination with 2 other approved drugs. People may attend study visits to the clinic or hospital for about 1 to 5 hours. Some people may need to be hospitalized for at least 4 days to receive the study drug treatment. The entire study consists of 5 parts: screening, pretreatment, and post-treatment follow-up for about 3 years. There will also be a long-term safety follow-up lasting at least 15 years after the CABA-201 treatment. Medical tests will be done during the study to track the health of participants. (IRB#: IRB_00191241)
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 Baricitinib in Patients Ages 6 to 18 Years Old with Alopecia Areata
Alopecia Areata is sudden hair loss that often occurs in the hair on a persons head. This study will test a drug called Baricitinib to treat patients ages 6 to 18 years old with this disease. The drug has already been approved for adults with this condition. The study wants to see if the drug will help the specific age of patients with this disease. Participants will be treated with Baricitinib. The drug is taken as a liquid or a swallowed pill. Being in the study requires up to 18 study visits at the clinic over 2.5 years. Medical tests will be done during the study to track the health of participants. (IRB#: IRB_00166438)
Testing the Drug 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 BHV-8000 in Adults with Early Parkinsons Disease
Parkinsons disease is a chronic brain disorder causing issues with movement and balance. This study will test a drug called BHV-8000 to treat adults with early Parkinsons Disease. The study wants to see if the drug will help people with early onset of the disease and is safe. People in the study will randomly be chosen to receive BHV-8000 or a placebo. The placebo looks like the study drug but does not contain the medication. People in the study will write daily in a journal. Being in the study requires attending about 11 in-person visits at the study clinic over 1 year, unless continuing in an extension of the study. Medical tests will be done during the study to track the health of participants. People will be paid for study participation. (IRB#: IRB_00193758)
Testing the Drug Brelovitug for Adults with Chronic Hepatitis Delta Infection
Chronic (long-term) hepatitis delta virus (HDV) infection, which is the cause of chronic hepatitis D (CHD), leads to severe liver damage. This study will test a drug called brelovitug, also known as BJT-778. The study wants to see if the drug will help people with the disease and is safe. People in the study will receive brelovitug for about 22 months. The study drug is given as an injection under the skin. Being in the study requires attending 26 in-person visits at the study clinic between 2.9 and 3.2 years. Medical tests will be done during the study to track the health of participants. People are paid for study participation. (IRB#: IRB_00195217)
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 Cabozantinib in Pediatric Cancers
Cabozantinib is an approved drug shown to reduce tumor growth. This study will test the drug to treat types of pediatric cancers. The study wants to see if the drug will help people with the pediatric cancers and is safe. People in the study will keep a medical diary and take Cabozantinib as a swallowed tablet to see how the tumor responds. If the tumor becomes smaller or remains the same size and/or if no tumor forms participants may continue taking the study drug for up to 52 weeks. Study participation lasts about 64 weeks. Medical tests will be done to track the health of participants. (IRB#: IRB_00165978)
Testing the Drug CAL101 for People with Idiopathic Pulmonary Fibrosis
Idiopathic Pulmonary Fibrosis is a chronic lung disease causing thickening and scarring of lung tissue, making it difficult to breathe. This study will test a drug called CAL101 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 CAL101 or a placebo. A placebo looks like the study drug but does not have the medication. Being in the study requires 10 study visits at the clinic over about 40 weeks. Medical tests will be done during the study to track the health of participants. (IRB#: IRB_00189965)
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 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 IMVT-1402 in Adults with Graves Disease
Graves' disease is an immune system disorder that impacts the thyroid, causing health issues. This study will test a drug called IMVT-1402 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 IMVT-1402 or a placebo. The 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, home visits, and telephone calls over about 52 weeks. Medical tests will be done to track the health of participants. (IRB#: IRB_00186900)
Testing the Drug Iptacopan in Pediatric Patients with Primary IgAN
Primary IgAN is a chronic kidney disease. This study will test a drug called iptacopan to treat pediatric patients 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 receive the treatment twice daily. Being in the study requires about 11 in-person study visits to the clinic over 15 months. Medical tests will be done during the study to track the health of participants. People will be paid for study participation. (IRB#: IRB_00191700)
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 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 of home visits over about 14 months. Participants will keep a diet diary. Medical tests will be done during the study to track the health of participants. (IRB#: IRB_00194497)
Testing the Drug Mavorixafor for People with Congenital and Acquired Primary Autoimmune and Idiopathic Chronic Neutropenic Disorders
Chronic Neutropenia is an immune system disorder that affects the bodys white blood cells that may increase infections. This study will test a drug called Mavorixafor to treat people with this disorder. The study wants to see if the drug will help people with the disorder and is safe. People in the study will be randomly chosen to be treated with Mavorixafor or a placebo. A placebo looks like the study drug but does not have the medication. Being in the study requires attending in person and phone study visits over about 1 year. Medical tests will be done during the study to track the health of participants. People may be paid for being in the study. (IRB#: IRB_00184914)
Testing the Drug NEU-411 for Companion Diagnostic-Positive People with Early Parkinsons Disease
Parkinsons Disease affects the central nervous system of the body, causing issues of movement such as shaking, slowness, balance problems, and difficulty thinking. NEU-411 is a study drug to treat people with this disease. This 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 NEU-411 or a placebo. The placebo looks like the study product but does not have the medication. Being in the study requires about 19 in-person visits at the clinic over 67 weeks. Medical tests will be done during the study to track the health of participants. (IRB#: IRB_00188883)
Testing the Drug Nivolumab for Pediatric Patients with Recurrent or Progressive High-Grade Glioma
Recurrent or progressive high-grade glioma (HGG) is a brain tumor that rapidly grows and spreads within the brain or spinal cord. This study will test a drug called nivolumab to treat pediatric patients with HGG. This study wants to see if the drug will help people with the disease and is safe. Participants will receive nivolumab for about 2 weeks before a scheduled surgery to remove the tumor and then again after the surgery. Study participation includes 2 years of treatment and about 5 years of follow-up. Medical tests and surveys will be done to track the health of participants. (IRB#: IRB_00142607)
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 ONC201 for Pediatric Patients with Diffuse Midline Gliomas
Diffuse Midline Gliomas is a fast-growing pediatric cancer that forms in the brain. This study will test a drug called ONC201, alone or in combination with other drugs or radiation, to treat the disease. This study wants to see if the drug will help people with the disease and is safe. Participants will receive either ONC201 only or ONC201 in combination with another drug or radiation. Study participation includes about 2 years of treatment and 5 years of follow-up. Medical tests and surveys will be done to track the health of participants. (IRB#: IRB_00149140)
Testing the Drug Pacritinib in People with VEXAS syndrome
VEXAS syndrome is a severe disorder that affects the immune system making it hard to protect against infections. This study will test an already approved drug for other disorders called pacritinib to treat people with VEXAS syndrome. The study wants to see if the drug will help people with the syndrome and is safe. People in the study will be randomly chosen to participate in one of three groups to receive 200 mg pacritinib twice daily, 100 mg pacritinib + 1 placebo capsule twice daily, or 2 placebo capsules twice daily. A placebo looks like the study drug but does not have the medication. People in the study will write in a diary and complete surveys. Being in the study requires attending in person study visits at the study clinic for up to 2 years. Medical tests will be done during the study to track the health of participants. (IRB#: IRB_00186453)
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 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 Remibrutinib for People with Chronic Spontaneous Urticaria
Chronic spontaneous urticaria is a skin condition of itchy hives and/or swelling. This study will test a drug called Remibrutinib to treat people 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 Remibrutinib or Dupilumab (an already approved treatment). This comparison will help the study learn which drug works better. Being in the study requires 8 study visits at the clinic for up to 28 weeks. Medical tests will be done during the study to track the health of participants. (IRB#: IRB_00192715)
Testing the Drug Ritlecitinib for People Ages 12 Years and Older with Alopecia Areata
Alopecia areata is a condition that causes hair loss from the body. This study will test a drug called Ritlecitinib to treat people with the condition. The study drug Ritlecitinib 100 mg will be compared to Ritlecitinib 50 mg. The study wants to see if 100 mg once daily dose will help people with the condition and is safe. People in the study will receive one of the two doses (50 mg daily or 100 mg daily) of the study drug. Being in the study requires attending up to 9 study visits at the clinic over about 57 weeks. (IRB#: IRB_00189039)
Testing the Drug Ruxolitinib Cream for People with Hidradenitis Suppurativa
Hidradenitis Suppurativa is a chronic skin condition that causes painful lumps on the skin. This study will test the drug Ruxolitinib cream to treat people with Hidradenitis Suppurativa. 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 receive Ruxolitinib Cream or a cream without the medication. Later in the study, all people will receive Ruxolitinib Cream. People in the study will keep an electronic journal. Being in the study lasts about 1 year and requires in-person visits to the study clinic. Medical tests will be done during the study to track the health of participants. People will be paid for study participation. (IRB#: IRB_00192318)
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 or 4 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 Spesolimab for People with Pyoderma Gangrenosum
Pyoderma Gangrenosum is a rare skin disease that causes painful ulcers on the skin. This study will test a drug called Spesolimab to treat people with this disease. This 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 Spesolimab or a placebo. The placebo looks like the study drug but does not have the medication. Being in the study requires about 20 study visits at the clinic over 1.5 years. Medical tests will be done throughout the study to track the health of participants. (IRB#: IRB_00186539)
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 for People with Primary Generalized Tonic-Clonic Seizures
Primary generalized tonic-clonic seizures are seizures that start in both sides of the brain at the same time. This study will test a drug called XEN1101 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 the study will be randomly chosen to be treated with XEN1101 or a placebo. A placebo looks like the drug but does not contain the medication. Being in the study requires attending in-person visits at the study clinic, with some phone call visits too. The study lasts up to about 29.5 weeks. Medical tests will be done during the study to track the health of participants. (IRB#: IRB_00159508)
Testing the Effects of Brain and hand muscle stimulation after stroke.
A stroke causes damage to the brain and can affect mobility on one side of the body. This study will test how brain stimulation combined with hand muscle stimulation improves hand movement in people who had a stroke. People in the study will complete medical tests to measure brain, hand, and nerve responses. Being in the study requires attending in-person visits at the study clinic for up to 27 sessions. (IRB#: IRB_00193557)
Testing the Effects of Spinal cord stimulation in 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 spinal cord stimulation 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 up to 30 sessions. (IRB#: IRB_00189382)
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 Medical Device PRESFLO® Microshunt for People with Primary Open-Angle Glaucoma who have Failed Previous Medical and Surgical Treatment
Open-Angle Glaucoma is a condition when pressure inside your eye (eye pressure) is too high causing damage to the optic nerve and/or decrease the visual field and even vision loss. The optic nerve transmits the images you see to your brain. Visual field is a measurement of a persons range of vision, from narrow to wide. This study will test a medical device called PRESERFLO® Microshunt to treat people with the condition. The study wants to see if the medical device will help people with the condition and is safe. People in this study will have the medical device surgically implanted into the eye. Being in the study requires participating for at least 1 year, some may be asked to attend annual study visits up to 5 years. Medical tests will be done during the study to track the health of participants. (IRB#: IRB_00184386)
Testing the Product StrataMGT for People with Vulvar Lichen Sclerosus Symptoms
This study will test a product called StrataMGT to treat people with Lichen Sclerosus. The product is a gel thats considered very low risk. This means it doesnt need special Federal Drug and Food Administration (FDA) approval to be used in studies or sold. The FDA has already decided it's safe enough without extra steps. This 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 StrataMGT or a placebo. The placebo looks like the study product but does not have the medication. Being in the study requires 4 in-person visits at the clinic over 14 weeks. Medical tests and surveys will be done during the study to track the health of participants. (IRB#: IRB_00186811)
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 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 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 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 Treatments for People with Amyotrophic Lateral Sclerosis
Amyotrophic lateral sclerosis (ALS) is a serious disease that affects the nerves in the brain and spinal cord. It causes muscles to weaken over time and can lead to death. This study is testing a drug called fluticasone propionate in adults with ALS. It will also look at four treatmentsZilucoplan, Verdiperstat, CNM-Au8, and Pridopidineto see if they are safe and if they help people with ALS. Participants in the study will be randomly assigned (like flipping a coin) to receive one of the treatments or a placebo (a substance with no active drug). The study lasts about 10 months and includes up to 8 clinic visits and 5 phone visits. During the study, medical tests will be done to check participants health. (IRB#: IRB_00143448)
Testing Ultrasonic Brain Stimulation for People with Fibromyalgia
Fibromyalgia is a condition that causes chronic pain in the body. This study will test low-intensity ultrasound brain stimulation to treat people with this disease. The study wants to see if the stimulation will help develop drug-free, effective ways for people with chronic pain. People in the study will have magnetic resonance imaging (MRI), a way to see the inside of the body. People will also have ultrasound brain stimulation and complete surveys about pain and other symptoms. Being in the study requires 7 in-person visits and 7 online visits over about 90 days. Participants are paid for time in the study. (IRB#: IRB_00188950)
The Benefits and Side Effects of Injected Cemiplimab into Tumors Compared to Removing Tumors Surgically for People with Early-Stage Cutaneous Squamous Cell Cancer
This study will test a drug called cemiplimab (se-mip-li-mab) to see if it can help treat early-stage cutaneous squamous cell carcinoma (CSCC), a type of skin cancer. Cemiplimab works by helping the immune system to kill cancer cells. Cemiplimab is used to treat locally advanced (cancer that has grown but has not spread to other parts of the body) or metastatic (cancer that has spread) CSCC. Cemiplimab is also used to treat other types of cancer (such as basal cell carcinoma and cervical cancer). Cemiplimab is usually given as an injection into the vein. In this study, cemiplimab will be given by an injection into the tumor (intralesional cemiplimab). Some people will be given cemiplimab injections for 6 weeks, and some people will have their tumor removed by surgery, which is the usual treatment that people have for early-stage CSCC. This will help researchers compare how well cemiplimab works compared to surgery. Being in the study lasts up to 3 years. (IRB#: IRB_00191239)
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 Effects of Social Media on Mental Health in Young Adults with Autism
This study wants to better understand how social media use relates to mental health among young adults with Autism Spectrum Disorder (ASD). Social media is a common part of daily life, and many young adults use platforms such as Instagram, TikTok, and Snapchat to communicate. However, people may experience social media differently. Participants in the study will complete an online survey that includes questions about social media use and feelings of anxiety, mood, loneliness, and self-esteem. Study participation lasts about 15-20 minutes. The study wants to learn both the helpful and challenging aspects of social media use among young adults with autism. The information may help develop more supportive resources and guidance to foster safer, more positive social media experiences in the future. (IRB#: IRB_00195986)
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)
Thought Processes When Forming Words
This study wants to learn how a person's thoughts form words. People in the study will view pictures on a computer and be asked to describe what they see. The responses will be recorded. Being in the study requires attending in person at the University of Utah. Participants will be paid for being in the study. (IRB#: IRB_00171949)
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)
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)
Tracking Health in People with Pulmonary Fibrosis and Other Lung Diseases
This study is a registry for people with Idiopathic Pulmonary Fibrosis and Interstitial Lung Disease. These conditions cause scarring and lung damage. A registry study does not test a treatment. Instead, it collects health information and blood samples over time to help researchers learn more about these conditions and support future research. Participating in this study involves completing surveys, interviews, and blood draws every 6 months over a 6-year period. The study will also collect information from medical records. The goal of the registry is to better understand Idiopathic Pulmonary Fibrosis and Interstitial Lung Disease to improve treatment and care. (IRB#: IRB_00195821)
Treating pregnant depressed people with TMS and rumination based therapy.
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 also 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. TMS and CBT sessions are done daily (Monday-Friday) by participants for 4-6 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_00195491)
Treating Pregnant People with Depression during Pregnancy
Depression is a very common and serious medical condition during pregnancy. This study wants to explore a mental health treatment called Cognitive Behavioral Therapy- Rumination Focused (CBT-RF) as an option for pregnant people who are already receiving an approved treatment called Transcranial Magnetic Stimulation treatment (TMS) for depression. TMS stimulates the brain using a non-harmful electrical current when wearing a type of cap on top of a persons head. People in the study will be interviewed, answer surveys, meet with a licensed therapist, participate in therapy for CBT-RF, and participate in fMRI scans. An fMRI is like a large, spinning magnet machine that rapidly creates pictures of the brain. Being in the study requires up to 10 visits to the clinic for about 6 weeks. Medical tests will be done during the study to track the health of participants. Participants will be paid for being in the study. (IRB#: IRB_00166560)
Trial of Parkinson's and Zoledronic Acid
This home-based study is a randomized (1:1) placebo-controlled trial of a single infusion of zoledronic acid-5 mg (ZA) for the prevention of fractures in men and women aged 60 years and older with Parkinson's disease and parkinsonism with at least 2 years of follow-up. A total of 3500 participants will be enrolled and randomized in the United States. Participants, follow-up outcome assessors, and study investigators will be blinded to assigned study treatment. This trial is funded by the National Institute of Aging. (IRB#: IRB_00170689)
U-STEP: A Health App for People with Peripheral Vascular Disease
The vascular system is made up of vessels that carry blood in the body and lymph (fluid in the body that carries white blood cells to fight infection). Vascular surgery is a way to help people with arterial diseases (narrowing of the blood vessels that reduce blood flow) and venous diseases (veins in the legs do not move enough blood back toward the heart). Such as peripheral vascular disease (PVD) a circulation (how the blood flows through the body) disease. The purpose of the surgery is to improve a persons quality of life, pain, and ability to function. The goal of our research is to see if using a smartphone app helps vascular surgeons and patients track their overall health. The information we gain may aid future patients. (IRB#: IRB_00162534)
Ultrasound as a Non-Invasive Treatment for People with Chronic Low Back Pain
This study will look at a new way to treat chronic low back pain. The study will collect two types of medical images, ultrasound and magnetic resonance imaging (MRI), to develop a new artificial intelligence tool that finds a small group of nerves near the spine called the dorsal root ganglion (DRG). The study wants to see if the ultrasound image, with the new AI tool, works as well as an MRI to help doctors see the dorsal root ganglion. This information will help doctors plan future medical procedures that will use a non-invasive technology called focused ultrasound (FUS) to reduce low back pain. People in the study will receive an MRI scan and then an ultrasound scan immediately after the MRI. Both will take about 30 minutes. People will be paid for study participation. (IRB#: IRB_00193760)
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 Articulation in Clarinet Performance: A Survey Study
This study aims to explore how people understand and describe articulation in clarinet playing. Articulation is an important part of clarinet performance, but because it happens inside the mouth, it can be difficult to observe and explain. For this reason, clarinet players and teachers often rely on spoken descriptions, metaphors, or syllables to explain how articulation should work. In this survey, we are collecting responses from adults who play the clarinet, teach clarinet, or work with clarinet players in educational or performance settings. By examining how different individuals think about and explain articulation, this study hopes to identify common ideas, differences in understanding, and areas where clarification may be helpful for teaching and learning clarinet articulation. (IRB#: IRB_00200227)
Understanding How Stroke Affects Walking and Balance When One Side of Space Is Ignored
After a stroke, some people have a condition called spatial neglect, which makes them pay less attention to one side of space, usually the left side. This can affect their safety, walking, and balance during recovery. After a stroke, some people have trouble noticing or responding to one side of space. This condition is called spatial neglect. It can affect balance, walking, and safety. Participants will complete simple paper-and-pencil or computer-based attention tests, stand on a floor sensor to measure balance, and walk along a short path while wearing small motion sensors attached to their shoes. The information from this study may help researchers and therapists better understand mobility problems after stroke. (IRB#: IRB_00178101)
Understanding Insurance Barriers to GLP-1 Medications for Weight Management
We are doing a study to understand how people get access to GLP-1 medications used for weight management, such as semaglutide or tirzepatide. Many people face insurance problems like high costs, denials, or delays. We want to learn what these experiences are like and how they affect care. We will interview adults who have tried to get a GLP-1 medication and health care providers who prescribe them. The goal is to better understand real barriers and help improve future access to these medications. Interviews take about 20-25 minutes and can be done by Zoom or phone. (IRB#: IRB_00197900)
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 Differences Between Posttraumatic Stress Disorder and Military Transition Stress in Veterans
Posttraumatic Stress Disorder (PTSD) and Military Transition Stress (MTS) can occur when veterans adjust to civilian life. PTSD is a well-known mental health condition caused by exposure to traumatic events, while MTS refers to the emotional and psychological challenges some veterans experience when leaving the military. These challenges can include feeling disconnected from civilian society, struggling to find a new purpose, or difficulty adapting to changes in work, relationships, and daily routines. This study seeks to determine whether PTSD and MTS are separate conditions or if they overlap in ways that impact diagnosis and treatment. Veterans participating in this study will complete surveys about their mental health, emotions, and daily experiences. These surveys will help researchers analyze symptom patterns and determine whether current screening tools accurately identify the unique challenges veterans face after leaving the military. The results of this study could lead to better mental health assessments, improved treatment options, and more effective support systems for veterans transitioning to civilian life. (IRB#: IRB_00188116)
Understanding the Importance of the Retina in Health and Neurological Diseases including Multiple Sclerosis
In this study, we will take pictures of the retina, which is the light-sensitive layer at the back of the eye. We will use a test called optical coherence tomography (OCT). This is a safe and commonly used test in medical care. The OCT scan measures the different layers of the retina, including those made up of nerve cells and nerve fibers. These measurements can give detailed information about the health of these layers. This helps researchers understand how diseases that affect the brain and nerves, such as multiple sclerosis (MS), may also affect the eyes. (IRB#: IRB_00056830)
Using Heart Rate Patterns to Measure Exercise Intolerance and Recovery for People after Concussion
Recovering from a concussion is different for everyone, and doctors currently rely on patients' descriptions of symptoms to track progress. Because brain injuries affect multiple systems in the body, it has been challenging to fully understand their impact or develop effective treatments. This study wants to identify measurable changes in metabolism, nervous system function, and sensory processing that could indicate the severity of a brain injury and predict how a persons recovery will progress. The study wants to improve diagnosis that will lead to earlier, more targeted treatments for people with brain injuries. People in the study will complete surveys about general health, symptoms, and quality of life, including the typical level of activity and function. Being in the study requires attending three in-person visits at the study clinic. Participation lasts about 3 months. Medical tests will be done throughout the study to track the health of participants. People will be paid for participation. (IRB#: IRB_00187566)
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)
Using Virtual Reality to Improve Balance Training
This study intends to develop new methods to improve balance and reduce falls. This study will use virtual environments to test the way balance responses are learned through practice. People in the study will complete surveys and walk while wearing a headset that shows a virtual environment. People will also wear sensors to track muscle activity while walking. Being in the study requires attending 2 in-person visits to the study clinic. Each visit lasts about 2 to 3 hours. People will receive payment for study participation. (IRB#: IRB_00191593)
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)
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: 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)