Search Results
Efficacy and Mechanisms of Combined Aerobic Exercise and Cognitive Training in MCI (The ACT Trial)
This study will be a multi-site, single-blinded, randomized controlled trial (RCT) that will screen older adults with mild cognitive impairment (MCI) using 4 steps (over the phone, in-person interview including informed consent, medical verification, exercise stress test/magnetic resonance imaging [MRI]). We will enroll 128 participants (target 96 completers, assuming 25% attrition rate at 6 months). After baseline assessment, participants will be enrolled and randomized within age (65-74 years of age or ≥75 years of age) and study site (Minnesota or Rochester) strata centrally at the University of Minnesota (UMN) to one of four groups: ACT, cycling only, SOP only, or control with equal allocation and using a randomization scheme generated by our UMN biostatistician (CI: Vock). Group allocations will be concealed to all investigators and data collectors. The interventions will last for 6 months with 12-month follow-up. Outcomes include: 1) cognition: composite measures of executive function and episodic memory, 2) AD signature cortical thickness: composite using structural magnetic resonance imaging (MRI), 3) functional connectivity in DMN: resting-state using functional MRI (fMRI), 4) aerobic fitness, and 5) clinical and pathological AD conversion. Cognition and aerobic fitness will be assessed at baseline, 3, 6, 12, and 18 months; AD conversion at 6, 12, and 18 months; and AD signature cortical thickness and DMN at baseline, 6, 12, and 18 months. PIs Yu and Lin have developed and tested strategies in their preliminary studies to successfully ensure the protection of human participants.
Russell Spafford - spaff010@umn.edu
• diagnosis of Mild Cognitive Impairment
• live in the community
• English speaking
• adequate vision
• physician confirms that exercise is safe
• stable on drugs affecting cognitive and psychological status
• able to have a MRI
• resting heart rate less than 50 or greater than 100
• additional medical or mental health diagnosis (study staff will review)
• enrolled in another intervention study related to cognitive improvement
A Clinical Trial of Cognitive Multisensory Rehabilitation for Sensory and Motor Recovery in Adults with Spinal Cord Injury
Almost 300,000 Americans with a spinal cord injury or disorder (SCI/D) suffer from reduced or complete loss of sensory and motor function, which can compromise functional independence and quality of life. The purpose of this study is to find better treatment options for improving sensation and movement after SCI/D.
Ann Van de Winckel - avandewi@umn.edu
• 18 to 75 years old
• incomplete or complete SCI/D of more than 3months
• medically stable.
• MRI contra-indications (stabilizing hardware is typically MRI safe)
• uncontrolled seizure disorder
• cognitive impairment and/or communicative disability (e.g., due to brain injury) that prevents following directions or learning
• ventilator dependent
• other major medical complications
• pregnant women
Autonomic regulation of blood pressure in premature and early menopausal women
The goal of this study is to learn more about the effects of menopause on women's blood pressure and heart health. We are looking for women between the ages of 35 and 70 years to participate in the study. Participants may be pre- or postmenopausal; we are specifically interested in evaluating the influence of premature (< age 40 years) and early (< age 46 years) menopause.
Emma Lee - leex4357@umn.edu
• 35 to 70 years old
• experienced premature (less than 40 years old) or early (45 or younger) menopause OR
• premenopausal 35-49 years of age OR
• typical-age menopause who are between 50-70 years old
• menopause will be confirmed by report of amenorrhea for 12 months
• nicotine or tobacco use within the past six months
• have diabetes or asthma
• diagnosed significant carotid stenosis
• additional medical diagnosis (study staff will review)
• women who are pregnant or breastfeeding
Improving Spinal Cord Stimulation with ECAP
The purpose of this study will be to investigate the optimization of spinal cord stimulation with ECAPs in patients with spinal cord implants.
Matthew Maple - maple036@umn.edu
• medically stable as determined by the principal investigator
• scheduled to have external spinal cord stimulation
• English-speaking
• scheduled for permanent implantation without an external trial
• have a pacemakers or other neurostimulators
• women who are pregnant
STRIKE-PE: A Prospective, Multicenter Study of the IndigoTM Aspiration System Seeking to Evaluate the Long-Term Safety and Outcomes of Treating Pulmonary Embolism
The purpose of this study is to collect information on how patients with PE recover after treatment with the Indigo Aspiration System. The Indigo Aspiration System is a medical device that has been cleared by the U.S. Food and Drug Administration (FDA) for removing blood clots from the blood vessels throughout the body, excluding the head. The device is commercially available globally. Participants will be in this research study for about one year. Participants will be asked to complete a screening and baseline visit, device procedure in-patient visit as part of routine treatment for their PE, one post-procedure visit in the hospital and two follow-up visits. The study team will collect information on tests and procedures done during these visits from their medical records. They will also be asked to complete a quality of life questionnaire.
Connie Dale - dalex179@umn.edu
• at least 18 years old
• diagnosis of acute PE within past 14 days or less
• unable to take heparin
• Stage III/IV cancer or cancer which requires active chemotherapy
• women who are pregnant
• other exclusions apply, contact study staff for more information
Study to Evaluate the Efficacy (Effect on Disease) and Safety of Finerenone on Morbidity (Events Indicating Disease Worsening) and Mortality (Death Rate) in Participants With Heart Failure and Left Ventricular Ejection Fraction (Proportion of Blood Expelled Per Heart Stroke) Greater or Equal to 40% (FINEARTS-HF) (FINEARTS-HF)
This study is a randomized, double-blind, parallel-group, placebo-controlled, multicenter, event-driven Phase 3 study with independently adjudicated clinical outcome assessments.
Michelle Pitt - henni032@umn.edu
• at least 40 years old
• diagnosis of heart failure with New York Heart Association(NYHA) class II-IV, or hospitalized primarily for heart failure
• on a diuretic medication for at least 30 days
• left ventricular ejection fraction (LVEF) of at least 40% measured any way in the last 12 months
• Myocardial infarction, coronary artery bypass (CABG), stroke or transient ischemic attack (TIA) in the last 90 days
• systolic blood pressure (SBP) 160 mmHg or greater if not on treatment with at least 3 blood pressure lowering medications or 180 mmHg or greater irrespective of treatments
• additional criteria apply (study staff will review)
ALX-HPP-501: An Observational,Longitudinal Prospective, Long-term Registry of Patients with Hypophosphatasia
This is a long-term registry is designed to collect data on hypophosphatasia (HPP) to better understand the condition and learn more about the disease, how patients feel about living with HPP and effect of HPP on the patients wellbeing and health. The study will look at participant’s medical records and health questionnaires about the health status of patients. This study collects observational data from clinical care and does not involve any treatment for HPP or administration of medication for HPP.
Kyriakie Sarafoglou - saraf010@umn.edu
• confirmed diagnosis of HPP.
• documented alkaline phosphatase (ALP) activity below the lower limit of normal for age and sex, or a documented ALPL gene mutation.
• able to read and speak English
• currently participating in an Alexion-sponsored clinical trial
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).
Spleen Imaging Study - spleenimagingstudy@gmail.com
• 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
Stress Response and Opioid Dysfunction in Nicotine Dependence
This study includes healthy adults between 18-70 years old who are either non-smokers or cigarette smokers interested in quitting. The purpose of this study is to learn more about how people respond to stress and to taking one dose of a widely and safely used drug called naltrexone as well as to learn about how these responses relate to whether or not someone smokes, smoking cessation, and smoking relapse.
Behavioral Medicine Laboratories - bml-tc@d.umn.edu
• Live in Minnesota.
• Between 18-70 years old.
• Generally healthy.
• Want to quit using tobacco and nicotine.
• Are willing to attend up to 11 online (videoconference) study visits over a period of approximately 4 months (though you may be asked to complete the last visits over a period of up to 1 year).
• Do not live in Minnesota.
• Not between 18-70 years old.
• Not willing to attend to up to 11 online (videoconference) study visits over a period of approximately 4 months.
Prospective quantitative kinematic assessment of patients with normal pressure hydrocephalus
This is a prospective study aimed at quantifying walking and balance in normal pressure hydrocephalus (NPH) patients in the clinical setting. To accomplish this, we will use a portable motion capture system that is widely used to study biomechanics in humans. Once quantified, we want to test the effects of ventriculoperitoneal shunt (VPS) on walking and balance among NPH patients. Thus, our objectives are: Aim 1: We will demonstrate the use of quantitative kinematic data on NPH patients pre-lumbar drain, post-lumbar drain and post-VPS in order to assess the predictive value of CSF removal on gait and balance. Aim 2: We will demonstrate the use of objective, neuropsychological data on NPH patients pre-lumbar drain, post-lumbar drain and post-VPS in order to assess the predictive value of CSF removal on cognition 3. We will demonstrate the use of objective, physical therapy data on NPH patients pre-lumbar drain, post-lumbar drain and post-VPS in order to assess the predictive value of CSF removal on therapeutic intervention in terms of walking and balance measures.
Alec Jonason - jonas074@umn.edu
• People who have dementia of sufficient severity to impair their ability to make health-care decisions
• People who have other types of Parkinson's Disease
• People who are unable to stand without help
Methodology and Development of Tobacco Related Biomarkers Methodology and Development of Tobacco Related Biomarkers, part of 'Metabolism of Carcinogenic Tobacco-Specific Nitrosamines'
The purpose of this study is to better understand how tobacco and nicotine products affect our bodies. In this observational study smokers, vapers, smokeless tobacco users, nicotine replacement product users, non-users, and ex-users will be asked to provide biological samples. We will look for biological “markers” (biomarkers), or chemical changes in the body, that occur due to tobacco or nicotine exposure. Collected samples will be used for the development of biomarkers of toxicant exposure and for assessing exposure between the different groups. The intent is to eventually use these biomarkers to improve detection, prevention, and treatment strategies for tobacco-related diseases. This study will allow us to test currently used biomarkers, and to establish a biorepository (sample bank) to identify and develop new biomarkers associated with tobacco exposure and cessation. The type of samples and amount collected will depend on the specific biomarker(s) being developed or tested. Potential samples include saliva, cheek (buccal) & oral cells, blood, urine, hair, and/or nail clippings.
Laura Garcia Pimentel - garci970@umn.edu
• 21 years or older
• Daily user of tobacco or nicotine products
• Unstable health condition
• Pregnant or nursing
Determinants of Renal Structural Responses to Enzyme Replacement Therapy (ERT) in Fabry Disease Study (LDN6702)
The effect of enzyme replacement therapy on how well your kidneys are responding to enzyme replacement therapy (ERT) is not clear from blood and urine tests alone, but may be more clear in comparisons of kidney biopsies performed before and some time after ERT has been initiated, and this is what we are focusing our study efforts on. The purpose of this study is to obtain your permission to allow us to study the kidney biopsy tissues (collected for medical reasons) after the regular routine studies have been completed. Through our special research measurements and additional study, we hope to be able to see and measure very specific changes in the kidney tissues from Fabry patients taking ERT. We also hope that through these studies of what happens within the kidney before and after starting ERT, we are able to reveal valuable information about the importance of factors like your age that you started ERT, the amount or dosage of ERT, and any differences seen between males and females.
Michael Mauer - mauer002@umn.edu
• diagnosed with Fabry disease and a clinical decision has been made to obtain a kidney biopsy, a GFR, and urinary albumin studies
• have previously completed clinical trials which included measures of renal function and renal biopsies
• serum creatinine more than 2.5 mg/dL
• known to have a renal disease other than Fabry
A person-centered employment preparation program for adolescents and young adults with autism spectrum disorder and their families
This study includes the development and evaluation of a person-centered employment preparation program for families of transition-aged youth with autism.
Rebekah Hudock - kale0040@umn.edu
• between the ages of 15-25
• have a medical diagnosis of Autism Spectrum Disorder (ASD) or educational eligibility for special education services under the category of autism
• verbally fluent (can speak in complete sentences and have basic conversation) and speak and understand English
• have access to WiFi and two devices with webcams
• at least one caregiver are able to commit to attending 8 90-minute virtual intervention sessions
• do not live in MN
• medical, behavioral, or mental health concerns that make it too difficult to participate in the study or that necessitates a higher level of care
DegenPRO: A multicenter prospective registry for the management of degenerative spine disorders
This is an observational registry database for adult patients diagnosed with degenerative spine disorders, which aims to add information to the understanding of the disease management of this spine diseases. By creating this registry, a more complete picture of degenerative spine disorders - including treatment practices - will be established, by collecting information about the health status of patients across several hospitals in several countries. Research of this kind will help future patients by providing doctors with information about degenerative spine disorders, and about patients' treatment outcomes. Data from this registry may be used to generate descriptive statistics on demographics, and clinical characteristics, including co-morbidities, treatment patterns and adverse outcomes (resulting from treatment or disease), as well as patients' quality of life measurements. Condition: Patients with a degenerative spine disorder Intervention/procedure investigated: No specific treatment required. Study design: Prospective case series
Christopher Martin - mart1865@umn.edu
An Open Label Study to Evaluate DPCP Ointment for the Treatment of Alopecia Areata
This is an open labeled study to determine the response and characteristics, safety and efficacy, of the proprietary DPCP ointment composition as a topical immunotherapeutic agent for the treatment of extensive alopecia areata.
Jaime Nugent - speck007@umn.edu
• diagnosis of extensive alopecia areata
• women of childbearing age must agree to use an acceptable, highly effective method of birth control to prevent pregnancy
• women who are pregnant or breast feeding
• current controlled or uncontrolled infection of any type
• systemic therapy for cancer within the past five years except for adequately treated Squamous Cell Carcinoma (SCC) or Basal Cell Carcinoma (BCC) of the skin
• additional medical conditions, treatments for alopecia areata, or mental health diagnosis (study staff will review)
Post-operative Sore Throat and Gum Chewing for Long Duration LMA Use
The purpose of this study is to determine if chewing gum immediately prior to transport to the operating room reduces the severity of post-operative sore throat in patients who have an LMA placed for procedures with duration greater than 1 hour.
Jonah Pearson - pears731@umn.edu
• having outpatient ambulatory surgery
• receiving general anesthesia utilizing a laryngeal mask airway
• surgery expected to last longer than 1 hour
• chronic laryngitis
• chronic bronchitis
• asthma
• gastroesophageal reflux disease
• smoked within the last week
• non-English speaking
Optimization of deep brain stimulation parameters in patients with medically refractory epilepsy
This study will develop a platform for stimulation setting optimization based on power spectral density (PSD) measures. Randomized, controlled trials have demonstrated that stimulation of the anterior nucleus of the thalamus (ANT) suppresses seizures. The central hypothesis tested here will be that PSD measured in the ANT will correlate with seizure frequency and stimulation settings that suppress broadband activity will result in lower seizure rates.
Robert McGovern - rmcgover@umn.edu
Improving Diagnosis and Treatment in Catecholaminergic Polymorphic Ventricular Tachycardia (CPVT)
This is a multi-center, prospective, observational cohort registry study looking at kids and their relatives with Catecholaminergic Polymorphic Ventricular Tachycardia (CPVT).
Brittany Faanes - grego318@umn.edu
• anyone diagnosed with CPVT before 19 years of age.
• significant medical history that isn't related to CPVT
Mechanisms of Rigidity Enhancement with an Activation Maneuver in Parkinson's Disease
This study will investigate neural mechanisms underlying the enhancement of rigidity with an activation maneuver (contralateral voluntary movement such as hand tapping) in people with Parkinson's disease. Rigidity will be measured using a custom robotic manipulandum while neural activity will be assessed using EEG and TMS protocols.
Joshua De Kam - jadekam@umn.edu
• Diagnosis of idiopathic PD as determined by a movement disorders neurologist
• 21 to 80 years old. Healthy participants must be 18 to 80 years old.
• Diagnosis of dementia
• Significant arm tremor or very limited arm movement
• History of other neurological disorders
• Pregnancy
Neuroplasticity of the motor system in people with idiopathic REM sleep behavior disorder
The purpose of this project is to evaluate motor system neuroplasticity and brain structure and function in people with Rapid Eye movement (REM) sleep behavior disorder (RBD) and healthy control participants. Our general hypothesis is that people with idiopathic REM sleep behavior disorder (RBD) will show abnormalities in motor cortical plasticity and alterations in structural and function connectivity that are consistent with changes observed in early Parkinson’s disease (PD).
Joshua De Kam - jadekam@umn.edu
• Diagnosis of isolated REM sleep Behavior Disorder (iRBD) confirmed by polysomnogram
• able to walk independently without using an assistive device (cane or walker) for 50 meters
• 21-75 years old
• For Healthy Volunteers: able to walk independently without using an assistive device (cane or walker) for 50 meters and 21-75 years old
• diagnosed with dementia
• history of musculoskeletal disorders that significant affect movement of lower or upper limbs
• other significant neurological disorders that may affect participation or performance
• Anti-depressant associated RBD.
Development of a Non-invasive Approach to Test Cortical-Brainstem Motor Pathways in Humans
The purpose of this project is to develop and test a novel non-invasive brain stimulation protocol, using transcranial magnetic stimulation (TMS), that will allow reliable examination of cortical-brainstem motor pathways in humans.
Joshua De Kam - jadekam@umn.edu
• Healthy adults: age 21-50 years
• People with diagnosis of hereditary spastic paraplegia:
• age 21-50 years
• able to stand, unassisted, for more than 2 minutes
• history of a frequent fainting in response to blood, needles, emotional or sensory triggers
• on anti-coagulant medications
• musculoskeletal disorder that affects the ability to stand
• history of seizures, epilepsy, stroke, multiple sclerosis or traumatic brain injury
• presence of any metal in the brain or implanted pacemaker
• history of surgery on blood vessels, brain or heart
• unexplained, recurring headaches or concussion within the last six months
• moderate to severe hearing impairment
• pregnancy
Humanitarian Use Device: Medtronic DBS Therapy for Dystonia (HDE #H020007) (Dystonia IRB)
Humanitarian Use device application for DBS therapy for dystonia
Kelly Ryberg - rybe0010@umn.edu
• 7 to 99 years old
• diagnosed with chronic, intractable (drug refractory) primary dystonia determined by a neurologist or neurosurgeon
• patients who are at significant surgical risk as determined by the neurosurgeon and/or anesthesiologist
• patients who have not had an adequate trial of medical or non-surgical treatment
Validation of Visual Stimuli for Eating Disorders Research
The goal of this study is to identify food and body images that may cause strong emotional responses among individuals with eating and weight-related concerns. Specifically, the researchers are looking to identify a set of food images and body images that can be used in future research studies to examine differences in emotion-based reactions between individuals with and without eating disorder symptoms. Ultimately, this knowledge may help us better understand food and body-related emotional processes that might contribute to eating disorder attitudes and behaviors.
Maya Day - day00186@umn.edu
• At least 18 years old
• Currently have an eating disorder and/or in treatment for eating disorder
• Engage in restrictive eating patterns
• For healthy participants: no diagnosis of eating disorder or restrictive eating patterns
• Unable to read English language fluently
The (IRAD) International Registry for Acute Aortic Dissection (CCMOCPAAD)
The International Registry of Aortic Dissection (IRAD) was created in 1996 by cardiovascular specialists committed to expanding current knowledge of aortic dissection with the goal of improving patient outcomes. This registry study uses a standardized form to capture data from consecutive patients with aortic dissection at participating hospitals.
Nicholas Lemke - ntlemke@umn.edu
• 18 to 80 years of age
• clinical diagnosis of acute aortic dissection
• Type A dissection
• Type B dissection
• Retrograde type B dissection
• Aortic aneurysm
• Myocardial infarction
• Cerebral accident
• Active infection
Neural Bases of Disgust Conditioning in Anorexia Nervosa
We are studying the brain patterns of people who have anorexia nervosa and those who don't have anorexia nervosa. We will look at MRIs, behavioral measures, and questionnaires to see if we can identify the brain activity associated with disgust. There will be a follow-up at 6 and 12 months.
Maya Day - day00186@umn.edu
• Anorexia Nervosa Participants: females between 18- 50 years old who meet criteria for diagnosis of Anorexia Nervosa
• Healthy Participants: healthy females age between 18-50, no previous diagnosis of Anorexia Nervosa or other psychiatric disease.
• Meets criteria for substance abuse disorder or actively suicidal
• Neurological condition or other developmental disorder
• MRI contraindication
• Inability to read English
Corrona Inflammatory Bowel Disease (IBD) Registry
This is a prospective, non-interventional, research study for patients with IBD under the care of a certified gastroenterologist. The primary objective for this registry is to prospectively study the natural history of IBD, the prevalence and incidence of comorbidities, targeted adverse events, and more, via questionnaires.
Lulu Chen - chen8124@umn.edu
• at least 18 years old
• Diagnosis of one of the following by a gastroenterologist: Crohn's disease or Ulcerative colitis (UC)
• users of an approved biologic drug or JAK inhibitor (Tofacitinib) for the treatment of UC or Crohn's disease
• Participating in or planning to participate in a clinical trial studying new medications for Crohn's disease or Ulcerative colitis
Clinical Evaluation of a Novel Neuromuscular Blockade Monitoring System
The purpose of this study is to compare information (twitch count, TOF ratio) yielded by this novel system with a newer, state of the art, electromyographic monitoring system. In addition the purpose is to compare device performance in a subset of patients with their arms tucked and thumbs largely immoblized.
Candace Nelson - nelso377@umn.edu
• scheduled to undergo any elective surgical procedure under general anesthesia in the MHealth East Bank operating rooms
• administration of a nondepolarizing neuromuscular blocking drug (rocuronium or cisatracurium) is anticipated
• procedure is being done as an emergency
• procedure occurring in the evening or weekend
A Pilot Trial of UrApp, a Novel Mobile Application for Childhood Nephrotic Syndrome Management
We are studying a new phone app, UrApp, for parents (or caregivers) to use when managing the care of children who have been diagnosed with nephrotic syndrome in the last six weeks. We will look at medication and urine monitoring with two groups; one will use the app, the other will have usual care. Study participation will last for one year.
Jenna Jensen - jens1538@umn.edu
• caregivers of children ages 1-17 with steroid sensitive nephrotic syndrome within 4 weeks of starting corticosteroid treatment
• caregivers of children with steroid sensitive nephrotic syndrome diagnosed within 42 days at the time of starting the study
• access to internet or Wi-Fi in the home
• caregiver proficient with the English language
• caregivers of children with end-stage kidney disease, renal transplant, or secondary nephrotic syndrome (due to systemic lupus erythematosus)
Safety and Acceptability of Patient -administered Sedation During Mechanical Ventilation
The primary objective of the study is to assess the efficacy of patient controlled sedation (Self-management of sedative therapy) using dexmedetomidine to reduce anxiety, delirium incidence and duration of mechanical ventilation compared to usual sedation practices in mechanically ventilated subjects.
Craig Weinert - weine006@umn.edu
• receiving mechanical ventilation (ventilator) in the Intensive Care Unit
• receiving medication for sedation or pain
• prone (facing down) ventilation being used
• low blood pressure that is being treated with medication
• unstable medical condition (staff will review)
Focus in NeuroDevelopment (FIND) Network: A Statewide Network for Research in Neurodevelopment
The purpose of this research project is to develop a registry and database of families with neurodevelopmental disorders.
Amy Yang - yang3958@umn.edu
• All ages
• All individuals with disabilities and families within the neurodevelopmental disorder community
• Also looking for clinicians, educators, and professionals in the field