Search Results
The Lung Cell Study (TLC)
The purpose of our research study is to increase our understanding on the human lung immune response to infection. We aim to use this knowledge to develop novel approaches on the prevention and treatment of lung infections. To accomplish this, we plan to obtain cells from the airways and blood of healthy volunteers to perform immune experiments.
• healthy volunteers without systemic or respiratory disease
• non-smokers or former smokers who quit more than 6 months ago (including marijuana)
• ages 18-50
• preferred but not required: have lived in countries in Africa, Latino America or South East Asia
• preferred but not required: history of positive tuberculosis (TB) skin or blood test
• recent illness, bleeding disorders, or a history of heart, lung, or systemic disease
• weakened immune system or use of immunosuppressant medication
• use of inhaled substances in the past six months or history of heavy smoking
• allergy or prior adverse reaction to lidocaine, midazolam, or fentanyl
• pregnancy
A Randomized, Multicenter, Double-Masked, Vehicle-Controlled Phase 2/3 Study to Evaluate the Safety and Efficacy of NEXAGON® (Lufepirsen Ophthalmic Gel) in Subjects with Persistent Corneal Epithelial Defects (NEXPEDE-1) (NEXPEDE-1)
The clear layer at the front of the eye that covers the pupil and iris (colored part of the eye) is called the “cornea”. When the cornea is damaged, it normally heals within a few days but it may take up to 2 weeks depending on the size and depth of the defect (wound). Some corneal defects heal much slower than expected. A defect in the cornea that fails to heal within the normal time of 2 weeks despite using the best available medicines and procedures, is known as Persistent Corneal Epithelial Defect (or PCED for short). The purpose of this research study is to evaluate the safety, tolerability, and effectiveness (risks and benefits) of of NEXAGON ophthalmic gel for the treatment of PCEDs.
• at least 2 years old
• diagnosis of Persistent Corneal Epithelial Defect (PCED) for at least 2 weeks that hasn't responded to one or more conventional non-surgical treatments
• active eye infection that requires treatment
• additional eye conditions that exclude study participation (study staff will review)
Assessments of sound perception and brain activation in response to paired sound and electrical stimulation of surface ear regions
We are investigating how paired non-invasive electrical stimulation of surface body regions and sound changes sound perception and tinnitus. Body stimulation regions include: external ear/behind the ear, shoulder, neck, forearm, hand, and upper arm. We aim to better understand the optimal conditions of this paired stimulation, which opens opportunities for applying this method to improving hearing loss or tinnitus. We are studying three groups of people: those with normal hearing, those with mild to moderate hearing loss, and those with tinnitus.
• normal hearing or hearing loss with or without tinnitus
• not users of Cochlear Implant or hearing aids
Characterization of spleen motion and anatomy using imaging and sensors
This research is being performed to examine how the spleen moves during breathing in various body positions and breathing conditions. Physical measurements of the participant's body will be recorded (weight, height, and body dimensions) and then noninvasive recordings of the spleen and breathing patterns will be recorded. The spleen motion will be measured using standard abdominal ultrasound imaging, and breathing will be measured with accelerometers (small devices about the size of a quarter that measure the movement of the chest during breathing).
• at least 18 years old
• individuals who have had a splenectomy
• people with breathing difficulties and/or individuals for whom short breath holds and modification of breathing patterns is difficult or uncomfortable
• unable to maintain five body positions: sitting, sitting with a 45 degree recline, laying on back (supine), laying on right side, and laying face down (prone) comfortably and independently
• unable to speak and read English
Rectus sheath block with liposomal bupivacaine versus thoracic epidural analgesia for pain control following pancreatoduodenectomy: a prospective, randomized, non-inferiority trial
In this study, we are comparing two different numbing techniques performed by anesthesiologists. Patients in the study are randomly selected to receive one or the other type of numbing injection. One group of patients will receive an epidural, which is a numbing injection done in the back, similar to that which women receive when they give birth. The other group of patients will receive a rectus sheath block, which is a numbing injection done on the abdomen. Both of these types of numbing injections are performed regularly by our anesthesiologists at the University.
• pancreaticoduodenectomy at the University of Minnesota
• chronic opioid use
• women who are pregnant
• see link to clinicaltrials.gov for complete exclusion criteria
A seamless, Phase 1b/2 multiple ascending dose/proof of concept study of XTMAB-16 in patients with pulmonary sarcoidosis with or without extrapulmonary manifestations
XTMAB-16 is a new, experimental drug and is part of a group of drugs known as tumor necrosis factor alpha (TNF α) inhibitors. TNF is a protein in your body that causes inflammation. TNF α inhibitors work by suppressing part of the immune response along with reducing inflammation. We are conducting this research study to see if XTMAB-16 will help in the treatment of pulmonary sarcoidosis.
• Diagnosis of pulmonary sarcoidosis with some respiratory symptoms
• Must be taking 7.5 to 25 mg of prednisone daily and will to taper down dose
• Must be on an additional medication for the treatment of sarcoidosis
• Please contact umnsarc@umn.edu if you have any questions
• Pregnancy or breast-feeding
MT2022-45 Primary Immune Regulatory Disorders (PIRD): Longitudinal Study of Clinical Presentation, Treatment and Outcomes
Primary Immune Regulatory Disorders (PIRD disorders) are a group of diseases that cause the immune system to function abnormally and cause infections, autoimmunity or inflammation that can begin early in life. PIRD is usually caused by changes in genes in DNA. Researchers are trying to learn what types of medical problems patients with PIRD have and how these respond to treatment. Researchers also want to learn which genes cause PIRD and how it can cause the medical problems of PIRD.
• age 0 to 99 years
• diagnosis of immune-mediated bowel disease affecting at least one segment of the bowel
• evidence of interstitial lung disease (ground-glass opacities) or pulmonary nodules/cysts
• decreased lung function
• additional inclusion and exclusion criteria apply (study staff will review)
• also enrolling parent, sibling, or child of eligible participants
• documented HIV infection
Validation of Flexible, Wearable Sensors to Detect and Monitor Tics
The goal of this study is to design wearable, comfortable sensors to measure muscle movement during tics. Small, flexible EMG sensors (the size of the head of a pin) will be embedded in a “band-aid like” plastic sticker which is placed on the side of the face. Participants will be video recorded as they complete movement tasks. The entire visit will take approximately 2 hours.
• 10 to 21 years old
• must have chronic tics present for at least 1 year
• must have at least one facial tic that occurs at least approximately once every 2-5 minutes
• active acute skin disorders
• previous diagnosis of psychosis or cognitive disability
• currently suicidal
Inhibitory Mechanisms of Negative Urgency in Adolescent Suicidal Behavior
This study is being done to better understand how the brain and impulsive decision-making are connected to depression and suicidal behaviors in people ages 13-21. Participants will complete clinical assessments, behavioral measures, undergo an MRI scan and complete transcranial magnetic stimulation with electroencephalography (TMS-EEG). There will be follow-ups at 6 and 12 months.
• 13-21 years of age
• current unipolar depressive episode
• lifetime history of suicidal ideation OR suicidal behavior
• lifetime history of psychosis, hypomania, mania
• historical diagnosis of autism spectrum disorder or intellectual disability
• pregnancy
• neurological disorders
• MRI contraindications (metal implants, fragments or devices)
CLINPRT-7: Intermediate Patient Population Expanded Access Protocol for MBP134 for Patients with Sudan Virus Disease (SVD)
The purpose of this open-label Expanded Access Protocol (EAP) is to provide access to MBP134, for treatment of Sudan Virus Disease (SVD). Patients will receive a single IV infusion of 50 mg/kg MBP134. Patients will be monitored and assessed daily through discharge for safety and the incidence of serious adverse events (SAEs), and of all adverse events (AEs) during infusions.
• people of any age who have a documented positive RT-PCR for Sudan Virus Disease (SVD) in the last 10 days
• OR a documented positive RT-PCR test for SUDV more than 10 days ago but continue to have symptoms of SVD
• OR acute symptoms compatible with SVD and a close contact with some who has RT-PCR confirmed SVD
• OR Infants born to mothers who have a positive RT-PCR results for SUDV within 10 days of birth or with a documented positive RT-PCR test for SUDV in >10 days but with ongoing symptoms of SVD
• women of who are of child-bearing age must use highly effective contraception for 90 days after receiving the medication
• any medical condition that, in the opinion of the physician, would unreasonably increase risk of side effects (study staff will assess)
RCT01437: Proactive infliximab optimization using a pharmacokinetic dashboard versus standard of care in patients with inflammatory bowel disease: The OPTIMIZE Trial
The purpose of this study is to find out if using a computer program (called iDose) to guide infliximab dosing is more effective and safer than using standard infliximab dosing over 52 weeks. All patients in this study will be receiving infliximab as part of their medical care, this study is only looking at two different methods of determining the dose and timing of administration.
• 16 to 80 years of age
• diagnosis of moderate to severe Crohn's disease (CD) or Ulcerative colitis
• physician intends to prescribe infliximab for treatment
• have not previously taken infliximab
• pregnant or breastfeeding
• complications of inflammatory bowel disease (IBD) such as abscess, need for ostomy (study staff review)
• current infection in last 6 months
• other significant medical conditions (heart, lungs, liver, endocrine etc.)
Testing the feasibility of a clinic-based assessment of exercise-induced maximum heart rate and heart rate recovery in adults without cardiovascular disease
We want to explore whether it is possible for adults without symptoms of heart disease to perform a short, high intensity exercise routine in a clinic setting in order to measure maximum heart rate and heart rate recovery. If this method is successful, it could be used by patients and clinicians to estimate and track heart health over time.
• able to perform short-term intense exercise
• history of heart disease such as heart failure, valve disease, arrhythmia etc.
• resting symptoms of shortness of breath or chest discomfort
• resting heart rate of 100 or greater
• high blood pressure
• women who are pregnant
• unable to speak and understand English
REACT-AF: The Rhythm Evaluation for AntiCoagulaTion with Continuous Monitoring of Atrial Fibrillation (REACT-AF)
This research is being done to assess whether it is safe and effective to stop oral anticoagulation medications (a blood-thinning medication) during prolonged periods of normal heart rhythm in participants with infrequent episodes of atrial fibrillation (AF).
• history of symptomatic or asymptomatic paroxysmal or persistent atrial fibrillation (AF) and a moderate risk of stroke
• documented prior stroke (ischemic or hemorrhagic) or transient ischemic attack (TIA)
• reversible causes of AF (e.g., cardiac surgery, pulmonary embolism, untreated hyperthyroidism).
Amblyopia Treatment Study (ATS23): A Randomized Trial of Dichoptic Treatment for Amblyopia in Children 4 to 7 Years of Age (ATS23)
Amblyopia (sometimes called 'lazy eye') is reduced vision in one eye caused by abnormal visual development early in life. The weaker (or 'lazy') eye often wanders inward and outward. Amblyopia is the leading cause of reduced vision in children and can lead to blindness if not treated. Treatments for amblyopia are glasses, and if needed, further treatment with part-time patching or penalization with atropine eye drops. Patching or atropine are administered to the stronger eye to force the child to use the weaker (amblyopic) eye. In recent years, an alternative type of therapy has emerged. It is called dichoptic treatment and involves stimulating both eyes simultaneously but with different stimuli. When it was first introduced, it was done in an office-based setting. Home-based technologies utilizing games and movies have been developed and studied to a limited extent in younger children with amblyopia. In this study, we will use a system called Luminopia. It uses a virtual reality headset to view web-based videos in which the contrast of the image seen by the stronger eye is reduced by 15% from that of the weaker eye. Luminopia has been available for use in the U.S. since 2022 and has been approved by the FDA for the treatment of amblyopia in this age group. In a previous large randomized trial, home-based dichoptic movies were shown to be superior to glasses alone but treatment effectiveness compared to patching (the gold standard for treating amblyopia) has not yet been established. If dichoptic therapy using the Luminopia system is confirmed to be at least as effective as patching, it would be an appealing alternative for treating amblyopia in young children, as it shows promise of better adherence and an easier treatment experience for the parent and the child. Children in this study would be randomized 1:1 to either the Patching Group or the Luminopia Group and followed for at least 6 months. Children in the Patching Group will have the option to do the Luminopia treatment after 6 months of patching. They will be followed for an additional 6 months. Thus, their participation will last for a total of 1 year.
• children 4 to 7 years old
• amblyopia (lazy eye) associated with strabismus, anisometropia, or both (previously treated or untreated)
• parent has phone (or access to phone) and is willing to be contacted
• prism lenses or need of a prism prescription
• currently wearing bifocals
• known skin reactions to patch or bandage adhesives
• history of light-induced seizures
A US Multi-center, Prospective, Non-interventional, Long-term, Effectiveness and Safety Study of Patients Treated with SKYTROFA (lonapegsomatropin) (SkybriGHt) (SkybriGHt)
Skytrofa is approved in the U.S. for sale and use in children with growth hormone deficiency (GHD). This study is being done to find out how safe and useful Skytrofa is for long-term treatment. A child’s care will follow the normal treatment practices at the clinic. There is no new treatment or medicine involved and no additional visits will be performed.
• 1 to 18 years old
• on treatment with SKYTROFA (lonapegsomatropin)
• participating in any interventional clinical study
Genetics of Developmental Disorders - Data and Specimen Repository (Le-Na)
This project is a data and specimen repository for developmental disorders. Participants provide biological samples and permission to store their health-related data. The purpose is collect and manage these materials for use in biomedical research related to developmental disorders.
• All ages
• Individuals with a developmental disorder (mostly but not exclusively developmental brain disorders)
• Parents and other selected relatives of individuals with developmental disorders
Cochlear Implantation in Children with Asymmetric Hearing Loss or Single-Sided Deafness Clinical Trial
• ages 4 to 14 and 11 months old
• parents and child fluent in English
• parents desire functional hearing in both ears for their child
• severe to profound sensorineural hearing loss in one ear and normal hearing in the other ear
• if older than 5 years, documentation of progressive hearing loss (i.e. passed newborn hearing screening, or significant change in hearing)
• see link to clinicaltrials.gov for complete inclusion and exclusion criteria
• medical condition that contraindicates a cochlear implant, including abnormal hearing nerve
• already using a cochlear implant
Optimization of deep brain stimulation parameters in patients with medically refractory epilepsy
The purpose of this research is to better understand how deep brain stimulation settings can affect the electrical activity in the brain and the frequency of seizures. There are a number of different ways in which the deep brain stimulation electrodes can be programmed to stimulate the brain. This research study uses the implanted battery in the chest to record electrical activity from the brain at different stimulation settings. We then use this electrical activity to determine stimulation settings that are “personalized” to your brain.
myAirvo 3 (High Flow Nasal Therapy; HFNT) for COPD patients in the home - a multi-center randomized controlled trial
The purpose of this research is to learn if home use of high flow nasal therapy (HFNT) increases the time to rehospitalization for people with chronic obstructive pulmonary disease (COPD). Participants will be randomly (by chance; like the flip of a coin) assigned to one of two groups. One group will receive usual medical care for COPD. The other group will receive usual medical care for COPD and use a high-flow nasal therapy device for a minimum of 8 hours daily. Participants will complete daily COPD symptom reports. This research will last for at least 12 months and up to 24 months.
• at least 30 years old
• history of a severe COPD requiring hospitalization in the previous six weeks
• specific requirements for FEV1 and FVC (study staff will review)
• current smokers must refrain from smoking when using supplemental oxygen or the myAirvo-3 device
• women of reproductive are are required to use highly effective contraception for at least 1 month prior to starting the study and agree to use such a method during study participation
• able to read and communicate in English
• current use of positive airway pressure (PAP) therapy; continuous positive airway pressure (CPAP), or non-invasive positive pressure ventilation (NPPV)
• women who are pregnant or breast feeding
• recent upper airway surgery (within the previous month)
• recent head or neck trauma (within the previous month)
• require oxygen greater than at 15 L/min
• inability to tolerate nasal prongs
Multicenter ALS Imaging Study
The purpose of the study is to test new biomarkers of ALS using MRI scans at 3 Tesla (3T). A biomarker is a measurable characteristic that can be used as an indicator of a particular disease state. Identifying biomarkers in ALS will help test new treatments and may help us make diagnoses earlier.
• for people who have Amyotrophic Lateral Sclerosis (ALS): less than 24 months since symptoms started, and diagnosis of probable or definite ALS
• for people with ALS and healthy volunteers: able to read, write and speak English, and able to have a MRI
• any condition that makes MRI unsafe or if unable to comply with instructions
• healthy volunteers with clinically significant abnormal findings on neurological examination
Time Restricted Eating as a Viable Alternative to Caloric Restriction for Treating Hyperglycemia in a Population with Type 2 (T2DM) diabetes (SFS3)
The purpose of the study is to see how restricting the eating window (called time-restricted eating) might affect eating habits, weight, and blood measures compared to reducing food intake. Time-restricted eating means that people would have a daily 8 hour eating window during which time they can eat whatever they want. Outside of the eating window, people would only take water and your medications. We expect that participants will be in this research study for about 7 months.
• 18 to 65 years old
• overweight/obese and have type 2 diabetes treated with diet or metformin
• BMI between 25-45 kg/m2
• HbA1c between 6.5-8.5%
• self reported weight must be stable (+/- 5 pounds) for at least 3 months prior to the study
• own a smartphone
• women who are pregnant or are planning to become pregnant
• eating disorders
Maternal Stress, Human Milk Composition, and Neurodevelopmental and Feeding Outcomes
This study explores the associations between maternal stress, breastmilk composition, and feeding and neurodevelopment for preterm infants in the NICU and at 4 months corrected age.
• preterm infant born between 28 0/7 and 32 6/7 weeks' gestation
• mother is 18 to 45 years of age at the time of delivery
• mother's BMI between 18.5 to 40 kg/m^2 before pregnancy or at first trimester
• preterm babies with significant health issues at birth
• mothers: a) alcohol consumption >1 drink per week or any tobacco use during pregnancy, b) history/current Type I or II diabetes or gestational diabetes mellitus, c) known congenital metabolic, endocrine disease or congenital illness affecting infant feeding/growth
Dissecting the role of acetaldehyde in oral carcinogenesis
The goal of this study is to better understand how drinking alcohol may lead to oral cancers. Acetaldehyde, a chemical formed when the body breaks down alcohol, is believed to play an important role. This study will measure acetaldehyde and DNA damage levels in the mouth of participants after a low dose of alcohol. The levels will be compared between three groups, all having different degrees of risk for developing oral cancer, and with non-drinkers to identify DNA damage that might be important to cancer formation. We also want to understand how alcohol can affect the bacteria in our mouths and how that might impact oral DNA damage.
• Alcohol drinkers of Eastern Asian descent who experiences flushing (reddening or warming of face) when drinking {ages 21 - 45}
• Alcohol drinkers who have Fanconi Anemia {ages 21+}
• Never drinkers {ages 18 - 45}
• Tobacco or nicotine users
mGlide-Care: A mHealth Partnership with caregivers to improve HTN management in patients with cognitive impairment
The purpose of this study is to learn about a new way of managing hypertension using a wireless blood pressure monitor and a smartphone. The goal is to improve hypertension care in older adults with memory loss or mild dementia in partnership with their caregiver.
• adults ages 60-85 years
• diagnosis of hypertension
• diagnosis of mild cognitive impairment or early stage Alzheimer's Disease/Related Dementias
• participant has an unpaid family caregiver
• severe comorbid illness including end-stage kidney disease, end-stage liver disease,
• participant and caregiver unable to complete study tasks or have plans to relocate in the next 12 months
• serious psychiatric illness that could interfere with treatment, assessment, or compliance
Pilot of standardized cognitive behavioral therapy for young adults with sickle cell disease
A pilot study looking at an adult-based non-pharmacologic interventional trial in collaboration with psychologist who has expertise in cognitive behavioral therapy (CBT) for adolescents with chronic disease and intellectual disability and developing processes towards independence in non-Sickle Cell Disease settings.
• 18 to 28 years old
• diagnosis of sickle cell anemia
• transitioning to adult care at UMMC from pediatric care for SCD
• unable to speak and write English
• have had more than 2 visits as a new patient in the adult UMMC sickle cell clinic
A Prospective, Multi-center, Randomized Controlled Blinded Trial Demonstrating the Safety and Effectiveness of VNS Therapy® System as Adjunctive Therapy Versus a No Stimulation Control in Subjects With Treatment-Resistant Depression (RECOVER)
The purpose of this study is to determine whether active Vagal Nerve Stimulation (VNS) Therapy is better than no stimulation VNS Therapy in improving health outcomes for subjects with Treatment-Resistant Depression (TRD). All participants in this study will receive a VNS Therapy surgical implant, which works to reduce the symptoms of depression by sending mild electrical pulses to the vagus nerve in the neck. The vagus nerve is connected to areas of the brain associated with controlling the mood. Data will be collected on responses to study treatments, quality of life, productivity, and use of healthcare services.
• current diagnosis of major depression for at least two years or at least 4 episodes of major depression
• have an inadequate improvement in symptoms with at least 4 antidepressant treatments
• on at least one antidepressant with a stable drug schedule for at least 4 weeks
• enrolled in Medicare or Medicare Advantage
• Currently uses, or is expected to use during the study, short-wave diathermy, microwave diathermy, or therapeutic ultrasound diathermy
• acute suicide risk or suicide attempt within 6 months
• history of other major mental health diagnosis (staff will review)
• treatment with another device or experimental drug
Self-Weighing for Weight Management in Adolescents Seeking Obesity Treatment: A Randomized Pilot
This study will test whether adding in daily weighing (5-7 days per week) is helpful in weight loss. In adults, it has been found to be helpful to have individuals who are obese to be more successful with their weight loss efforts if they weigh themselves at home every day. We want to see if this could be helpful in children as well. This research will last for about 12 weeks (3 months).
• aged 12 to <18 years
• BMI at the 95th percentile or greater
• weight loss or maintenance determined as the treatment goal by PWMC provider
• any unhealthy weight control behaviors
• participation in other PWMC study
• developmental delay
• diagnosis that might cause weight fluctuations in weight
• severe anxiety or depression
Development of objective measures for multisensory effects on hearing
Paired sound and electrical stimulation can alter how the brain encodes sounds and the perception of sounds, as shown in emerging evidence from animal studies. The aim of this study is to develop measures for paired stimulation that can be used reliably. These measures assess the following aspects of hearing: basic hearing sensitivity and cochlear health, perception of loudness and pitch, and perception of speech and other complex sounds. This will lead to a greater understanding in the hearing science community about how multisensory stimulation can alter activity in the auditory system and sound perception, which may lead to new techniques for improving hearing disorders.
• not users of hearing aids or implanted devices
• normal hearing or hearing-impaired, with or without tinnitus
• users of hearing aids or implanted devices
Visual Perception in Visual Snow Syndrome
This study seeks to understand visual perception in people with Visual Snow Syndrome and how this relates to brain function.
• Between 18 - 60 years old
• Good general physical health
• No history of other neurological disorders or problems
• Fluent in English
Influence of Exercise on the Gut Microbiome of Overweight and Obese Adults with Prediabetes
We are looking at how an 8-week exercise program of walking for 30-45 minutes 3 times/week affects the body. This study is for people who are prediabetic and overweight or obese. We will compare the exercise group to a group that didn’t participate in the exercise to see if there are differences in gut microbes, body measurements, and blood work.
• 30-64 years old
• classified as overweight or obese with BMI greater than 25 kg/m2
• physician diagnosed as pre-diabetic or HbA1c value of 5.7 - 6.4% obtained during study screening
• currently exercise less than 100 minutes per week
• physically able to exercise
• no antibiotics taken for at least 45 days
• weight has been stable for the last 6 months (less than 10% change)
• willing to maintain current diet and exercise levels unless changed by the study
• current gastrointestinal illness
• taking metformin or other medications for high blood sugar
• history of bariatric surgery
• pregnant or breast feeding