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A Phase 1, Randomized, Observer-blind, Placebo-controlled, Age De-escalation Study of the Safety, Tolerability, and Immunogenicity of mRNA-1345 and mRNA-1365 in Participants Aged 5 months to <24 months; mRNA-1365-P101
This study is recruiting children ages 5 months to less than 2 years learn about safety and effects of two Moderna study vaccines. The study vaccines are being designed to prevent respiratory tract infections caused by two common viruses, Respiratory Syncytial Virus (RSV) and Human metapneumovirus (hMPV). The child will be randomized to receive one of the two study vaccines or placebo. The placebo will look like the study vaccine but will not have a vaccine in it. The study lasts 24 months and the child will receive 3 injections with other study activities, such as blood draws and nose (nasal) swabs.
• Ages 8 to 12 months at time of enrollment
• Symptomatic RSV or hMPV infection since birth
• Previous hospitalization for respiratory illness
• Serious chronic illness, autoimmune disease, or neurological disorders
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
Kinematic signatures of postural instability and gait in healthy adults
The purpose of this research is to better understand balance and walking in a healthy adult population to compare to patients with Parkinson’s Disease. This research study uses small wearable devices that attach to your clothing and can measure your body’s location while performing walking and balance tests. We expect that you will be in this research study at the Minnesota State Fair for approximately 10-15 minutes.
• any neurological disease
• history of vertigo
• dementia of sufficient severity to impair the ability to make decisions
D2D: Grief Literacy Survey
The Investigators will survey voluntary participants at the 2024 MN State Fair, inquiring as to their knowledge and attitudes about grief, loss and bereavement. This information will be used to understand the level of existing grief literacy in the general population represented by this sample, and inform further studies about grief literacy: a public health response to grief and bereavement. The researchers anticipate 200-300 completed surveys.
D2D: The Great Minnesota Heart Health Check
This is a study that will collect cardiovascular health information from people at the MN State Fair.
• at least 18 years old
• live in Minnesota
• have an active email address
• unable to speak, read and understand English
Listening effort in people with hearing impairment
The purpose of this research is to understand the effort needed to understand speech if hearing is impaired. Listening effort is higher in people with hearing impairment and has wide-ranging negative consequences across many aspects of a person’s life. The goal of this project is to explore factors that make listening effortful, with special focus on the need to repair perceptual mistakes by relying on context.
• There are two categories of participants: either people with cochlear implant (one or two cochlear implants) or people with normal hearing in both ears. All participants must be 50-75 years old.
• non native English speakers
Lifestyle Counseling and Medication for Adolescent Weight Management (QUEST)
This study will compare the effectiveness and durability of intensive behavioral counseling vs. medical management plus low-intensity behavioral counseling on BMI, body fat, cardiometabolic risk factors, and quality of life in adolescents with severe obesity. We hypothesize that Wegovy (semaglutide) plus low-intensity behavioral counseling will elicit superior reductions in BMI and body fat and greater improvement in cardiometabolic factors and quality of life compared to intensive behavioral counseling at 56 weeks.
• ages 12-17
• BMI greater than or equal to the 95th percentile for age and sex
• Type 1 or Type 2 diabetes
• use of medications for obesity in the past 6 months
• any treatment with growth hormone
• bariatric surgery -major mental health diagnosis (study staff will review)
• pregnant or plan to become pregnant
• significant medical diagnosis (study staff will review)
HM2023-11 PH I study of ven/aza or ven in combination with ziftomenib (KO-539) or 7+3 induction chemo with ziftomenib for AML pts
There are certain genetic changes in the leukemia cell thought to drive the disease in patients with acute myeloid leukemia. Ziftomenib is an investigational drug that blocks the menin pathway in hopes of preventing or slowing the leukemia cells from growing and dividing. The purpose of this study is to determine the safe dose of an investigational new drug (ziftomenib) used in combination with other study drugs i.e., venetoclax and azacitidine, to treat cancer. This will include an evaluation of side effects associated with ziftomenib in combination with the other study drugs and how ziftomenib works in combination with the other study drugs (venetoclax and azacitidine).
• newly diagnosed or relapsed/refractory Acute Myeloid Leukemia (AML) with specific mutation (study staff will review)
• able to walk and capable of all selfcare but unable to carry out any work activities; up and about more than 50% of waking hours
• adequate liver, renal, and cardiac function
• women and men of child bearing age must follow specific requirements for birth control
• other types of leukemia
• active involvement of central nervous system
• clinically active human immunodeficiency virus, active hepatitis B or active hepatitis C infection
• women who are pregnant or breast feeding
• additional criteria (study staff will review)
Role of Pharmacotherapy in Counteracting Weight Regain in Adolescents with Severe Obesity
In this study we want to find out more about weight loss and how diet and medications can affect weight loss. This study will last for up to 58 weeks. There are two phases to the study: - A weight loss phase with prescribed meals that lasts 6 weeks. - A study medication/placebo phase that lasts up 52 weeks. You will not know if you are receiving the medication or the placebo.
• severe obesity (BMI >/= 120% of the 95th percentile or BMI >/= 35 kg/m2)
• 12 to less than 18 years of age at enrollment
• female participants who are sexually active with males and who are able to get pregnant must agree to use two forms of contraception throughout the trial
• diabetes (type 1 or 2)
• current or recent (< six months prior to enrollment) use of anti-obesity medication(s) (use of naltrexone or bupropion alone is not an exclusion)
• previous metabolic/bariatric surgery
• current use of a stimulant medication
• history of glaucoma
• current or recent (<14 days) use of monoamine oxidase inhibitor
• history of treatment with growth hormone
• history of bulimia nervosa
• major psychiatric disorder
• any history of active suicide attempt
• history of suicidal ideation or self-harm within the previous 30 days
• current pregnancy or plans to become pregnant during study participation
• current tobacco use
• history of cardiac, endocrine, kidney disease (study staff will review)
D2D Kid Talk Study: How Do Kids Learn Language?
The purpose of this research is to better understand how children learn language. Child participants will complete problem solving and language-based tasks. Parents will complete two questionnaires about the child and their development. Results of this study will be used to help children with language-learning weaknesses.
• child must be 5 through 8 years old
• parent and child must speak and understand spoken and written (parent) English
• English must be the language spoken at home
• history or symptoms of a developmental or neurological disorder, such as stroke, traumatic brain injury, seizure disorders, cerebral palsy, or autism
• currently receiving speech-language, reading, or special learning services or have received these services in the past
• history of hearing loss
D2D Care Aware: Understanding Opioids in Minnesota
According to the Minnesota Department of Human Services, about 290,000 adults in Minnesota need treatment for addiction. National data suggests that only 10% of those who need treatment receive it. The goal of the study is to determine public opinion and knowledge about opioid use disorder and its treatment.
D2D WOW! Parents (Wellness on the Web and Parents)
This is a study about fitness and nutrition content on social media. You will be asked to complete a survey that should take 10 minutes or less. It will ask about your beliefs about fitness and nutrition, as well as online fitness, and nutrition content that your child may engage with. Study is taking place only on Monday 9/2 from 9 AM - 2 PM in the D2D building at the State Fair
• participant must be a parent of a child 11-20 years old
• able to speak and read English
• have access to an internet-connected device in their home
• child 11-20 years old must have access to an internet-connected device in the home
• study is taking place only on Monday 9/2 from 9 AM - 2 PM in the D2D building at the State Fair
Gender Identity Measurement In Early School Aged Children
The goal of this study is to learn more about how children (ages 5-8 years) describe their gender identities. We are also interested in learning more about the ways children think and develop. We will be giving children several tasks designed as games to assess flexibility in thinking, creativity, and the ability to take another person’s perspective.
• Ages 5 to 8
• English speaking
• unable to speak English
Biomechanical Mechanisms of Soft Tissue Deformation during the Volleyball Spike
No current studies have examined in vivo glenohumeral kinematics during the overhead volleyball spike despite the high prevalence of spike-related shoulder pain. The extreme shoulder positions achieved by volleyball players during the spike motion may contribute to unique deformations that could result in structural change or pathology of the rotator cuff and long head biceps tendons. The purpose of this study is to determine the extent to which GH kinematics differ between SAB and a simulated volleyball spike at a self-selected position of ball contact.
• 18 to 35 years old
• played at least 2 years of high school varsity-level volleyball and/or play competitive volleyball at the club level or NCAA D3/NAIA level or above
• have no shoulder pain that has resulted in removal from, or cessation of volleyball participation in the past 6 months
• have a negative clinical screening exam
• fluent in English
• any injuries, impairments, or pain of the hitting arm that limits participation in volleyball
• shoulder pain related to the cervical spine
• history of trauma and/or surgery of the hitting shoulder
• currently pregnant.
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 music/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
FAST, RELIABLE, ELECTRICAL UNCONSCIOUS DETECTION
We are interested in learning more about how preconscious thinking works. Preconscious thinking are thoughts you aren't actively thinking about but can be thought of quickly with the right trigger. It is similar to a waiting room for your thoughts. We believe that preconscious thoughts are important for learning more about symptoms related to suicide and psychosis. This research will help us better understand how the preconscious relates to these mental health outcomes. Participants will be asked to complete a research visit where they will complete computer tasks while being monitored with EEG and video recording. We'll also ask participants to complete pre-visit mood check-ins which can be done remotely.
• age 18 to 65
• Must be UMN student
• reads/understands English
• have a smartphone compatible with EMA app or willing to use study loaner phone for duration of EMA collection period (optional for initial group)
• ability to travel to research site for in-person visit at M Health Fairview University of Minnesota Medical Center - West Bank
• active military member or DoD personnel
• pregnant or possibility of being pregnant
• diagnosed with a mental illness (e.g. depression, bipolar, schizophrenia, etc.)
Neural underpinnings of understanding speech in different listening contexts
This study evaluates the neural underpinnings of understanding speech in different listening contexts, such as listening to two talkers simultaneously or speech in background noise.
• Group 1: Adults aged 18-70 years, normal hearing, proficient in spoken English
• Group 2: Adults aged 18-70 years, have hearing loss, proficient in spoken English
• Neurological problems
• auditory neuropathy spectrum disorder (ANSD)
• Wear a cochlear implant
TMS x DPX
We will examine whether the benefits of brain stimulation on mental functioning can be enhanced if an individual is actively engaging the target brain networks while receiving brain stimulation. The study includes two separate sessions and people will complete either a cognitive task or a perceptual task while we are measuring the change in brain function with EEG. Please fill out the linked screening questionnaire to determine if you are eligible.
• age 18 to 65
• diagnosed with a psychiatric disorder
• potential contraindications to EEG (e.g. visible scalp abrasions, non-removable hair extensions and/or hair styling that would impede proper EEG recording)
• potential contraindication to TMS (as identified by the TMS safety screener)
• any previous adverse reaction to TMS or MRI
• diagnosed with epilepsy or previously experienced a seizure
• diagnosed with a neurological condition, such as stroke or tinnitus
• experienced a head trauma that was diagnosed as concussion
• current use of, or recent withdrawal from, medications that can increase the risk of seizure
• currently pregnant
• any metal in the head (excluding mouth) or have an implanted medical device
Bias in the Counseling of Black Patients
The purpose of this project is to learn about the stereotypes and discriminatory treatment that Black patients encounter to develop communication skills training and tools for clinicians that reduces the likelihood that Black patients feel stereotyped and discriminated against. We will ask you to participate in a two-hour focus group, either in-person or virtually.
• English speaking
• age 25 and older
• Black or African American
• born in the US or arrived in the US at age 5 or earlier
• received care for high blood pressure in the last year
• live in the Twins Cities Area
• diagnosis of Cognitive impairment, dementia, or schizophrenia
• unable to see or unable to hear (hearing aids and glasses are fine)
Vasomotor symptoms of menopause and cardiovascular disease: What is the link?
Study to examine the physiological responses that occur during a hot flush in postmenopausal women
• Reported nicotine/tobacco use within the last six months
• Diabetic or asthmatic
• Diagnosed significant carotid stenosis
• History of significant autonomic dysfunction, heart disease, respiratory disease, or severe neurologic condition such as stroke or traumatic brain injury
• Existing metabolic or endocrine abnormalities
• Use of heart/blood pressure medications that are determined to interfere with study outcomes
• Use of oral contraceptives (or other hormonal contraceptives, including intrauterine devices or contraceptive implants) and/or hormone therapy
• Pregnant or breastfeeding
• Unwilling or unable to refrain from consuming caffeine or alcohol in the 12 hours before visit two and three.
• Unwilling or unable to refrain from vigorous exercise (at least 10 minutes in duration) in the 12 hours before visit two or three
• Unwilling or unable to fast in the eight hours before visit two or three
• Body mass index ? 35 kg/m2
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.
D2D: What is Possible in 30-Seconds? Measurement of Physical Function in Children and Adolescents
We want to learn more about children and teens strength, endurance, tiredness and level of physical activity. We want to find out how many times children and teens of different ages stand up and sit down in 30-seconds. It will take 10 minutes or less to take part in the study.
• children 3 to 17 years old
• speak English
• no known significant health problems that impact cognitive or physical function such as a neuro-motor disorder or a lower extremity injury
Pathogen Genomics Center of Excellence: Prospective Surveillance of Respiratory Pathogens and Antimicrobial Resistance in Diverse Regional Populations (MINNE-LOVE-2)
Respiratory illnesses, including ear and sinus infections, colds, and pneumonias, are among the most common infectious diseases affecting Minnesotans across their lifespan. These diseases can be caused by many different types of microbes—bacteria, viruses and fungi—and different types of microbes may require different kinds of treatment. This research is being done to learn more about the specific types of microbes that cause respiratory infections in children and adults across the state of Minnesota over time. Antimicrobial resistance happens when microbes develop the ability to defeat the drugs designed to kill them. Through this study, we will learn which types of genes are carried by microbes living in the respiratory tract by collecting and analyzing nasal and oral specimen.
• age at least 18 years and able to provide informed consent AND willing and able to collect nasal swabs and complete symptom questionnaires with symptomatic respiratory illness Or
• age less than 18 years within the same household of at least 1 adult participant in study AND parent/guardian available to provide informed consent AND self or parent/guardian willing and able to collect nasal swabs and complete symptom questionnaires with symptomatic respiratory illness
• presence of a condition or abnormality that in the opinion of the Investigator would compromise the safety of the participant or the quality of the data (e.g., parent not able to answer the questionnaire because of a psychological condition or an anxiety disorder that is severe)
• routine mucosal specimen collection is not medically advised (such as severe immunocompromising condition, bleeding disorder)
Physiological Monitoring of Participants with Chronic Pain Feasibility Study
We are asking people to participate in this study to help us learn more about how physiology (heart rate, sweating, temperature, etc.) of people with pain conditions changes based on perceived pain level. The goal is to use this information to help develop a new medical device designed to help better manage chronic pain, although we are only collecting information at this time, and there will be no treatment provided as part of this study. We expect that people will be in this research study for a maximum of 2 weeks.
• able to speak/understand/write English
• willing to complete requested information which includes: survey forms (~15-20 minutes) at study enrollment and upon completion, keeping an hourly pain diary for 5 hours on 5 different days within a 2 week period, returning the device promptly upon study completion
• have access to a computer and the internet for completing the diary
• have a diagnosis from a medical professional of one or more of the following: chronic low back pain, myofascial pain related to temporomandibular disorder (TMD), and/or painful peripheral neuropathy
• have had pain related to one or more of the previous diagnoses for at least 3 months, with pain being present on a daily basis, and with pain levels that change and/or "flare" at least on a weekly basis
• women who are pregnant or breast feeding
Measurement of Upper Aerodigestive Tract Pressures During Phonation
The purpose of this pilot research study is to test whether a tool called “High-Resolution Manometry” can diagnose laryngeal dystonia (also known as spasmodic dysphonia) and measure how well treatment works. High-Resolution Manometry measures pressures from a small catheter that is passed from your nose into your throat. We believe that pressures in the throat might be different for people with laryngeal dystonia than for people without laryngeal dystonia, or with other types of voice disorders. If we can diagnose laryngeal dystonia shortly after symptoms start, we can get patients the treatment they need sooner.
• experienced improvement in voice quality following injection of botulinum toxin into the thyroarytenoid complex
• received their most-recent injection within 6 months
• age 18-80 years old
• able to read and write in English
• For Healthy Controls:
• age 18-80
• have no known voice problem
• able to read and write in English Patients with Muscle Tension Dysphonia:
• Age 18-80 (age-and sex matched to adductor laryngeal dystonia)
• Diagnosis of primary muscle tension dysphonia by a laryngologist and speech pathologist in the ?...absence of current organic vocal fold pathology, [and] without obvious?neurologic etiology.?18
• Able to read and write in English
• Muscle tension dysphonia patients who either haven?t started voice therapy, or for whom symptoms persisted despite voice therapy
• diagnosis of vocal tremor, abductor laryngeal dystonia, any type of vocal fold lesion, or vocal fold paralysis
• known swallowing disorder (oropharyngeal or esophageal), with the exception of transient post-botulinum toxin injection-induced dysphagia
• pregnant
• prisoners
• allergy to topical anesthetic
• cannot fast for 6 hours (4 hour fast prior to study, up to 2 hours to complete the study)
• recent facial trauma
• recent nasal, pharyngeal, laryngeal, or esophageal surgery or obstruction
The effects of cigarette smoking and alcohol on DNA damage in the oral cavity
The purpose of this study to examine the effects of cigarette smoking and drinking alcohol on the formation of DNA damage in the mouth. The overall goal is to identify DNA damage that may be important to the development of head and neck cancers.
• 21 years of age or older
• Smoke cigarettes daily
• Drink alcohol regularly
• Use other tobacco/nicotine products
A Phase 1/2a Open-Label Dose-Ranging and Observer-Blind Placebo-Controlled, Safety and Immunogenicity Study of mRNA-1647 Cytomegalovirus Vaccine in Female and Male Participants 9 to 15 Years of Age; mRNA-1647-P104
This study it to test an investigational vaccine called mRNA-1647 that is being developed for preventing cytomegalovirus (CMV) infection in people. CMV is a common virus that can spread easily through an infected person’s saliva or other body fluids such as blood, urine, and breast milk. We want see if the trial vaccine can prevent CMV infection in participants who have not been previously infected, to understand the safety (how many side effects you may have) of the trial vaccine, and to see if the trial vaccine results in participants making antibodies to CMV.
• female or male 9 to 15 years of age
• in good general health
• BMI requirements ( study staff will review)
• female participants of childbearing potential: negative pregnancy test and adequate contraception for at least 28 days prior to receiving vaccine through 3 months following vaccine administration
• received, or plans to receive, any nonstudy vaccine less than 28 days prior to or after any study medication
• any diagnosis or condition requiring significant changes in management or medication within the 2 months before starting the study
• contact study staff for review of additional exclusion criteria
Effectiveness of Screening and Decolonization of S. aureus to Prevent S. aureus Surgical Site Infections in Surgery Outpatients
The purpose of this study is to determine the most effective ways to get rid of Staph aureus on body surfaces before surgery. We will determine if the participants can effectively get rid of the bacteria with the simple application of various treatment methods assigned to them. We will study if these methods are useful and cost effective in preventing the infections after surgery.
• at least 18 years old
• people who are scheduled for orthopedic, urology, neuro, otolaryngology, plastic and general surgery or OB/GYN surgery
• surgery is scheduled for at least 10 days following entry into the study
• have not taken antibiotics in the week before surgery
• will have a skin incision
• surgery scheduled less than 10 days after the baseline cultures
Save the Bottoms!!!: Assessing the Gay Male Experience with Anal Cancer Prevention Strategies
The purpose of this study is to describe current knowledge and opinions about anal cancer screening among men who have sex with men (MSM), as well as their experience receiving guideline-compliant care aimed at anal cancer risk reduction using a large-scale survey disseminated via social media.
• 18 years of age or older
• AMAB (Assigned Male at Birth)
• Current resident of the U.S.
• Engage in receptive anal intercourse with male partners
• Fluent in English or Spanish
The University of Minnesota Perinatal Health Repository
This research is being done to collect blood and placenta samples to better understand how pregnancy impacts the health of mother and child. The goal of this research is to better understand what causes some pregnancy complications and how this impacts the longer term health of mothers and children.
• pregnant women who are at least 18 years of age and their neonates/children
• seen in Obstetrics and Gynecology Clinics for pre-conception, prenatal or postpartum care