Search Results
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
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
Project SHINE (Sleep Health INitiative for Equity): Culturally informing a sleep extension intervention for African American adults
The purpose of the study is to better understand the experiences of healthy lifestyle behaviors (i.e., sleep and physical activity), and receive feedback on a sleep intervention that aims to improve sleep among African American adults who do not get enough sleep. Sleep is vital to engaging in a healthy lifestyle, living longer, and feeling energized throughout the day. This research will compare a sleep intervention program (“Sleep Intervention Group”) to a healthy homes education program (“Control Group”) to see if there are changes in sleep and physical activity among those in the Sleep Intervention Group. We expect that participants will be in this research study for about 6 weeks.
• not meeting Physical Activity Guidelines
• age range: 21 to 65 years
• body mass index range: 25.0 to 40 kg/m2
• average self-reported habitual sleep duration of ≤6 hours
• self-identify as Black or African American
• self-reported organ-related disorder (COPD, cardiac arrhythmia, gastro-esophageal disorder)
• pregnant or less than 4 months postpartum
• infant living in household less than 1 year old
Assessment of usability and satisfaction with a take-home device presenting sound and body stimulation for back pain
The purpose of this study is to measure the compliance, usability, and satisfaction of an at-home, multi-modal stimulation device in a diverse population of people with chronic lower back pain (cLBP) compared to a group of participants who are engaging in integrative health practices. The multi-modal device will include a combination of electrical stimulation, auditory stimulation, and integrative-health techniques, including mindfulness breathing, health coaching, and reflective journaling. The multi-modal device creation is based on prior knowledge in lower back pain treatment, which includes electrical stimulation of the back (Transcutaneous Electrical Nerve Stimulator or TENS) and integrative health modalities. Findings from this usability pilot study could help refine the approach and the multi-modal device for a future intervention study in cLBP participants.
• must have chronic lower back pain, defined as back pain lasting 3 or more months,
• willing to travel to the University of Minnesota and commit to the study duration
• cannot have any implanted stimulation devices
Transcranial Magnetic Stimulation to Augment Exposure and Response Prevention for Pediatric OCD (NExT)
We are doing this study to see if we can improve the standard treatment for OCD, Exposure with Response Prevention, by pairing it with Transcranial Magnetic Stimulation to the parts of the brain that cause OCD symptoms.
• 12 to 21 years old
• currently have OCD symptoms
• inability to have a MRI
• study staff will review additional exclusion criteria
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
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
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
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
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
teleABLE: Adapting a Behavioral Activation-Based Intervention to Reduce Post-Stroke Sedentary Behavior using Telehealth (Main Trial)
We are exploring ways to promote healthy lifestyles during stroke rehabilitation using a web-based rehabilitation program. The purpose of this study is to compare two intervention approaches: teleABLE and Healthy Lifestyles Education. Both interventions are delivered using video visits, so participants can complete all study activities from home
• at least 18 years old
• diagnosed with stroke more than 6 months ago
• report 6 or more hours of sedentary behavior on a typical day
• live in a community-based setting (i.e., personal residence, assisted living facility)
• mobile within the home, with or without an assistive device and without physical assistance
• Stroke participants will be excluded if:
• currently receiving chemotherapy or radiation treatments for cancer
• have a medical diagnosis of neurodegenerative disorder (i.e., dementia, Parkinsons disease, multiple sclerosis, amyotrophic lateral sclerosis, glioblastoma)
• received inpatient treatment for substance use disorder or psychiatric condition within the past 12 months
• have a history of skin sensitivity related to adhesives
• pregnant or expecting to become pregnant in the next 2 months
• live in an institutional setting
• currently incarcerated
• stroke participants will also be excluded if they have severe aphasia
NAPS2: North American Prodromal Synucleinopathy Consortium Stage 2
We are recruiting only healthy participants who do not have REM sleep behavior disorder. The information gained from this study will help the investigators understand more about REM sleep behavior disorder (RBD), and the possible underlying neurologic disorders that can cause RBD.
• male
• 54 to 75 years old
• Caucasian
• history of dream enactment
• diagnosis of Parkinson's Disease, dementia, MCI, or MSA
• blood relative with REM Sleep Behavior Disorder
Tissue biopsies for the study of FSHD
A single visit study with muscle and/or skin biopsy / blood draw, performed to determine whether a molecular or cellular defect can be attributed to cells of Fascioscapulohumeral Muscular Dystrophy (FSHD) muscle. This study is recruiting both individuals with genetically confirmed FSHD as well as unaffected healthy (control) individuals.
• Genetic confirmation of Fascioscapulohumeral Muscular Dystrophy (FSHD)
• at least 4 years old
• Healthy Family Members: parent or sibling of someone who has FSHD
• heart failure, respiratory insufficiency that requires respiratory support
• taking anticoagulants or anti platelet medications (aspirin or NSAIDs)
NRG-BN011: A Phase III Trial of Lomustine-Temozolomide Combination Therapy Versus Standard Temozolomide in Patients with Methylated MGMT Promoter Glioblastoma
We are looking at adding lomustine to temozolomide and radiation therapy when compared to temozolomide and radiation therapy alone (usual care). We will compare the effect (shrinking or stabilizing) and side effects when treating newly diagnosed MGMT methylated glioblastoma. Each of the drugs and radiation work in a different way to stop the growth of tumor cells.
• 18 to 70 years old
• no known IDH mutation
• must consent and have tumor submitted within 30 days of surgery
• adequate hematologic, kidney, and liver function (study staff will review)
• previous treatment of the brain tumor
• prior cancer (except non-melanomatous skin cancer, cervical cancer in situ and melanoma in situ) unless disease free for a minimum of 2 years
• women who are pregnant or breast feeding
A longitudinal study of imaging biomarkers in amyotrophic lateral sclerosis (ALS) and primary lateral sclerosis (PLS)
The purpose of the study is to test new biomarkers of amyotrophic lateral sclerosis (ALS) and primary lateral sclerosis (PLS) using MRI scans at 3 tesla (3T). Identifying biomarkers of a disease can lead to a better understanding of the disease as well as improved treatments.
• 21 to 75 years old
• diagnosis of possible, laboratory-supported probable, probable, or definite ALS or PLS
• other neurodegenerative diseases (Parkinson disease, Alzheimer's disease, etc).
• inability to undergo MRI scanning
• needs assistance to walk or climb stairs
A Randomized Phase III, Two-Arm Trial of Paclitaxel/Carboplatin/Maintenance Letrozole Versus Letrozole Monotherapy in Patients with Stage II-IV, Primary Low-Grade Serous Carcinoma of the Ovary or Peritoneum
We are looking at how well letrozole with or without paclitaxel and carboplatin works in treating patients with stage II-IV low-grade serous carcinoma of the ovary, fallopian tube, or peritoneum. Letrozole is an enzyme inhibitor that lowers the amount of estrogen made by the body and may stop the growth of tumor cells that need estrogen to grow. We will compare the effectiveness of the two different treatments.
• newly diagnosed, stage II-IV low-grade serous ovarian cancer fallopian tube or primary peritoneal cancers
• surgery for maximal cytoreduction completed within 8 weeks of randomization
• bilateral salpingo-oophorectomy completed
• able to take oral medications
• prior neoadjuvant chemotherapy, endocrine therapy or radiotherapy for the treatment of this disease
• severe cardiac disease
Randomized Phase III Study of Combination AZD9291 (osimertinib) and Bevacizumab versus AZD9291 (osimertinib) Alone as First-Line Treatment for Patients with Metastatic EGFR-Mutant Non-Small Cell Lung Cancer (NSCLC)
This trial compares the effect of bevacizumab and osimertinib combination vs. osimertinib alone for the treatment of non-small cell lung cancer that has spread outside of the lungs and has a change (mutation) in a gene called EGFR. Sometimes, mutations in this gene cause EGFR proteins to be made in higher than normal amounts on some types of cancer cells. This causes cancer cells to divide more rapidly.
• confirmed diagnosis of non-squamous, non-small cell lung cancer (NSCLC)
• have advanced disease, defined as - either stage IV disease, stage IIIB disease not amenable to definitive therapy, or recurrent disease
• no prior systemic treatment for metastatic disease
• able to walk and do all selfcare but unable to carry out any work activities; up and about more than 50% of waking hours
• additional inclusion criteria (study staff will review)
A Phase I/II, Multicenter, Open-Label, Single-Dose, Dose-Ranging Study to Assess the Safety and Tolerability of ST-920, a AAV2/6 Human Alpha Galactosidase A Gene Therapy, in Subjects with Fabry Disease
The purpose of this study is to test a new drug, called ST-920, to see if it is safe and if it works to treat Fabry disease. ST-920 is a gene therapy treatment, which means that ST-920 replaces the missing or broken gene you have because you have Fabry disease, with a version or copy that works.
• at least 18 years of age
• diagnosis of Fabry disease
• one or more of the following symptoms: i) cornea verticillata, ii) acroparesthesia, iii) anhidrosis, iv) angiokeratoma
• fully vaccinated for COVID- 19 per CDC guidance
• additional requirements apply for cardiac and renal groups (study staff will review)
• history of liver disease
• current or history of use in the last six months of systemic steroids
• other significant medical & mental health diagnosis (study staff will review)
Multimodal profiling of response to pediatric Comprehensive Behavioral Intervention for Tics
This study identifies the bio-behavioral predictors and correlation of responses to Comprehensive Behavioral Intervention to Tics (CBIT) in young people with tic disorder.
• age 10-17 years at time of enrollment
• current chronic motor and/or vocal tics, defined as tics for at least 1 year without a tic-free period of more than 3 consecutive months. Tics must not be due to a medical condition or the direct physiological effects of a substance
• at least moderate tic severity
• full scale IQ greater than 70
• English fluency to ensure comprehension of study measures and instructions
• inability to undergo MRI (e.g., metal in body, claustrophobia, orthodontia) and/or EEG
• actively suicidal
• previous diagnosis of psychosis, cognitive disability, or structural brain disease
• history of seizure disorder
• active substance abuse or dependence
• presence of another psychiatric or medical condition requiring immediate treatment and/or for which delay of treatment to focus on tics would be clinically inappropriate. Participants will not be excluded for comorbidities that commonly occur with TS (e.g., ADHD, OCD, anxiety) provided that this criterion is met
• concurrent psychotherapy focused on tics and/or involving procedures that overlap with CBIT (e.g., habit reversal therapy, exposure therapy targeting repetitive behaviors).
• psychotropic medication changes in the past 6 weeks and/or plans to change medication during the study period through post-treatment assessment
• four or more previous sessions of CBIT
The TrialNet Natural History Study of the Development of Type 1 Diabetes
TrialNet is an international research group dedicated to the study, prevention, and early treatment of Type 1 diabetes. Type 1 diabetes is now understood as a disease that develops over time in stages. Stage 1 starts with the appearance of having two or more autoantibodies. This is followed by Stage 2, which is the development of abnormal blood glucose levels. Stage 3 is the clinical diagnosis of Type 1 diabetes. This study will help us learn more about how Type 1 diabetes occurs through the screening of diabetes-related autoantibodies and monitoring individuals who have tested positive for these autoantibodies.
• 2.5 to 45 years old and have an immediate family member with type 1 diabetes (child, parent, or sibling)
• 2.5 to 20 years old who have an extended family member with type 1 diabetes (cousin, niece, nephew, aunt, uncle, grandparent, or half-sibling)
• already have diabetes
• history of being treated with insulin or oral diabetes medications
• using systemic immunosuppressive agents (topical and inhaled agents are acceptable)
• have any known serious diseases
Effects of Pallidal Deep Brain Stimulation Location on Motor Impairment in Parkinsons disease; Udall Project 2 Aims 1 & 2 Study
This protocol will characterize the effects of deep brain stimulation (DBS) location (both adverse and beneficial) on motor signs in people with Parkinson’s disease (PD). This information can be used to inform future DBS protocols to tailor stimulation to the specific needs of a patient. If targeted dorsal GP stimulation is shown to significantly improve motor features that are typically resistant to dopamine replacement therapy, these experiments will likely have major impact on clinical practice by providing a potential strategy to treat medically intractable symptoms.
• diagnosis of idiopathic Parkinson's Disease (PD)
• have a deep brain stimulator (DBS)
• have had a 7T brain scan
• history of musculoskeletal disorders that significantly affect movement of the upper or lower limbs
• other significant neurological disorder
• history of dementia or cognitive impairment
• post-operative complications or adverse effects of DBS
Kinematic signatures of postural instability and gait in Parkinson Disease
The purpose of this research is to better understand balance and walking in patients with Parkinson’s Disease. This research study uses small wearable devices that attach to clothing and can measure the body’s location while performing walking and balance tests.
• People diagnosed with Parkinson's disease, with or without implanted Deep Brain Stimulator (DBS). May be at any age of disease progression.
• Healthy adults of similar age to participants who have Parkinson's Disease and are enrolled in the study.