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Here are the studies that match your search criteria. If you are interested in participating, please reach out to the contact listed for the study. If no contact is listed, contact us and we'll help you find the right person.

426 Study Matches

A Multicenter, Randomized, Parallel-group, Double-blind, Two-arm, Phase III Study to Evaluate the Safety and Efficacy of Anifrolumab Compared with Placebo in Male and Female Participants 18 to 70 Years of Age Inclusive with Systemic Sclerosis (DAISY)

We are doing this study to learn more about anifrolumab (SAPHNELOTM) in patients with systemic sclerosis and to better understand the studied disease and associated health problems. Systemic sclerosis (scleroderma) affects the skin as well as other organs, such as blood vessels, muscles and joints, digestive tract, kidneys, lungs and heart.

Principal Investigator: Jerry Molitor
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: STUDY00019243
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Inclusion Criteria:

• 18 to 70 years old
• diagnosis of systemic sclerosis within 6 years from first non-Raynaud's symptoms
• skin at injections sites is without symptoms
• see link to clinicaltrials.gov for complete inclusion and exclusion criteria
Exclusion Criteria:

• severe heart or lung disease
• history of any other inflammatory diseases
• history of hematopoietic stem cell transplantation or solid organ or limb transplantation
• current or a history of cancer within past 5 years
• active current or history of reoccurring infections
Conditions: Arthritis & Rheumatic Diseases
Keywords: Clinics and Surgery Center (CSC), systemic sclerosis, Scleroderma
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First Carpometacarpal Osteoarthritis Evaluation: Determining the Concurrent Validity and Test-Retest Reliability of the Thumb Disability Index (TDX) and Test-retest Reliability of Thumb Position Sense-Error using the Intermetacarpal Distance (IMD) Method

We are studying different questionnaires used to measure symptoms and activity limitations that are linked to thumb arthritis. We are also studying ways to measure thumb position sense in persons with thumb arthritis.

Principal Investigator: Corey McGee, PhD, MS, OTR/L, CHT
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: STUDY00006741
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Inclusion Criteria:

• at least 18 years old
• osteoarthritis of the joint where the bones of the wrist meet the hand (CMC)
Exclusion Criteria:

• received steroid injection treatment in the past 3 months
• history of CMC joint replacement
• nerve problems in the wrist or hand
• women who are pregnant
• unable to speak English
Conditions: Arthritis & Rheumatic Diseases
Keywords: Arthritis, CMC, CMC/Carpometacarpal, Osteoarthritis
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Cochlear Implantation in Children with Asymmetric Hearing Loss or Single-Sided Deafness Clinical Trial

Principal Investigator: Kristin Gravel
Age Group: Up to 18 years old
This study is also accepting healthy volunteers
IRB Number: STUDY00010956
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Inclusion Criteria:

• 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
Exclusion Criteria:

• medical condition that contraindicates a cochlear implant, including abnormal hearing nerve
• already using a cochlear implant
Conditions: Ear, Nose & Throat
Keywords: Pediatric audiology, Audiology, Cochlear Implant, Single-Sided Deafness
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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.

Principal Investigator: Robert McGovern, MD
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: STUDY00011863
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Inclusion Criteria:
People who have medically refractory epilepsy with a deep brain stimulator in place
Exclusion Criteria:
People who have dementia of sufficient severity to impair their ability to make healthcare related decisions for themselves
Conditions: Brain & Nervous System
Keywords: Epilepsy, DBS, Deep Brain Stimulation
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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.

Principal Investigator: Nathaniel Gaeckle
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: SITE00001599
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Inclusion Criteria:

• 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
Exclusion Criteria:

• 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
Conditions: Respiratory System
Keywords: COPD
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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.

Principal Investigator: Alik Widge
Age Group: 18 years and over
This study is also accepting healthy volunteers
IRB Number: STUDY00019156
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Inclusion Criteria:

• age 18 to 65
Exclusion Criteria:

• 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
Conditions: Mental Health & Addiction
Keywords: cognition, EEG, rTMS
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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.

Principal Investigator: Pramod Pisharady
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: STUDY00021637
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Inclusion Criteria:

• 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
Exclusion Criteria:

• any condition that makes MRI unsafe or if unable to comply with instructions
• healthy volunteers with clinically significant abnormal findings on neurological examination
Conditions: Brain & Nervous System, Rare Diseases
Keywords: ALS, Amyotrophic Lateral Sclerosis, Primary Lateral Sclerosis
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Efficacy of Belimumab and Rituximab Compared to Rituximab Alone for the Treatment of Primary Membranous Nephropathy (REBOOT)

People with Primary MN lose more protein in their urine because the filters in their kidneys may be damaged. It is possible that some belimumab may also be lost in the urine because of this. This study will measure belimumab in the blood to decide if people with high urine protein should receive a higher dose of belimumab. Another purpose of this study is to help learn about whether the combination of belimumab and rituximab treatment is effective in making and keeping Primary MN inactive.

Principal Investigator: Patrick Nachman
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: STUDY00006831
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Inclusion Criteria:

• 18 to 75 years old
• diagnosis of Membranous Nephropathy (MN) or Nephrotic Syndrome (study staff will review specific requirements)
• hypertension while on maximum medications i.e. systolic BP greater than 140mmHg or diastolic greater than 90mmHg
Exclusion Criteria:

• Rituximab use within the previous 12 months
• poorly controlled diabetes mellitus defined as hemoglobin A1c (HbA1c) 9.0% or greater
• women of child-bearing age who are pregnant, nursing, or unwilling to be sexually inactive or use FDA-approved contraception for the duration of the study
• additional medical and mental health exclusions apply, study staff will review
Conditions: Kidney, Prostate & Urinary
Keywords: Clinics and Surgery Center (CSC), Membranous Nephropathy, Nephrotic Syndrome
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See this study on ClinicalTrials.gov

Hepatic Energy Fluxes, NASH, and Vertical Sleeve Gastrectomy

This study is looking at the liver function of people who have bariatric surgery. People who want to be in this trial must be obese, have abnormal liver function tests & prediabetes or type 2 diabetes. The study includes assistance with diet and exercise for a year after surgery.

Principal Investigator: Sayeed Ikramuddin
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: STUDY00006269
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Inclusion Criteria:

• age 18 to 67 years
• diagnosis of non-alcoholic steatohepatitis (NASH)
• Body Mass Index (BMI) 30.0-55.0 kg/m2
• willing to have surgical treatment and have insurance with no exclusion for obesity related treatments or management of obesity surgery complications
• live or work within approximately three-hour traveling time from the study clinic for the duration of the one-year trial
Exclusion Criteria:

• cardiovascular event (myocardial infarction, acute coronary syndrome, coronary artery angioplasty or bypass, stroke) in the past six months
• pulmonary embolus or thrombophlebitis in the past six months
• cancer diagnosis unless disease free for five years
• alcohol intake more than one drink per day
• other physical or mental health disease (study staff will review)
Conditions: Digestive & Liver Health
Keywords: Clinics and Surgery Center (CSC), Bariatric surgery, NASH, fatty liver, gastrectomy, gastric sleeve, sleeve, sleeve, VSG, weight loss
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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.

Principal Investigator: Sarah Wernimont
Age Group: 18 years and over
This study is also accepting healthy volunteers
IRB Number: STUDY00016978
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Inclusion Criteria:

• 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
Conditions: Women's Health
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An Early Feasibility Study Assessing Treatment of Pulmonary Arterial Hypertension Using the Aria CV Pulmonary Hypertension System (ASPIRE PH) (ASPIRE PH)

The objective of this study is to evaluate the safety and feasibility of implantation of the Aria CV PH System in subjects with pulmonary hypertension (PH) and right heart dysfunction. In addition, the study will evaluate early signals of performance of the implanted system.

Principal Investigator: Thenappan Thenappan
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: STUDY00011174
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Inclusion Criteria:

• diagnosis of Right heart dysfunction
• symptomatic despite being on a stable drug regimen
• diagnosis of lung disease, including but not limited to chronic obstructive pulmonary disease (COPD) or interstitial lung disease (ILD) including idiopathic pulmonary fibrosis (IPF) or combined emphysema with fibrosis
• ineligible for or refuses blood transfusion
• pregnant, nursing or is planning to become pregnant in the next two years
• see link to clinicaltrials.gov for complete inclusion and exclusion criteria
Exclusion Criteria:

• diagnosis of idiopathic hypertrophic subaortic stenosis
• untreated severe aortic or mitral stenosis
• heart failure with reduced ejection fraction
Conditions: Heart & Vascular
Keywords: Pulmonary Hypertension, Right Heart Dysfunction
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Biologic Abatement and Capturing Kids Outcomes and Flare Frequency in Juvenile Spondyloarthritis (BACK OFF JSpA) (BACK-OFF JSpA)

This study is enrolling participants who have been diagnosed with juvenile spondyloarthritis, are taking a tumor necrosis factor inhibitor (TNFi) and have reached a clinically inactive disease state for a minimum of six months. Researchers want to know if children who have maintained inactive disease for at least 6 months can maintain quiet disease without taking their medication as frequently or stop the TNFi therapy. Quiet disease means that disease related symptoms are not active or being experienced in the patient. Researchers also want to know the safest method to bring patients off medication. If a flare does occur during therapy reduction, researchers want to find out whether they can predict when a flare is most likely to happen, and how quickly an inactive disease state can be recaptured.

Principal Investigator: Colleen Correll
Age Group: Not specified
This study is NOT accepting healthy volunteers
IRB Number: SITE00001260
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Inclusion Criteria:

• age 8 to 21 years
• juvenile SpA diagnosis symptom with symptoms starting before their 16th birthday
• currently taking one of the following therapies (Adalimumab, Certolizumab, Etanercept, Golimumab, Infliximab) at standard doses
• have reached a clinically inactive state for at least 6 months
• English speaking or Spanish speaking
• willing to taper off medications
Exclusion Criteria:

• History of inflammatory bowel disease or history of uveitis
• psoriasis that started before TNFi therapy or psoriasis that started after TNFi therapy and has required more than topical therapy for control
Conditions: Arthritis & Rheumatic Diseases, Children's Health, Rare Diseases
Keywords: arthritis, Juvenile Spondyloarthritis
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MT2023-06: A CLINICAL STUDY TO ASSESS THE EFFICACY AND SAFETY OF LERIGLITAZONE IN ADULT MALE SUBJECTS WITH CEREBRAL ADRENOLEUKODYSTROPHY (CALYX)

This study has 2 parts: a double-blind period and an open-label extension. In the double-blind period of this study, the study medicine will be compared to a placebo. A placebo is a treatment that looks and tastes exactly like the study medicine but does not contain any active ingredient. In this study, you will receive leriglitazone or placebo. Whether you receive leriglitazone or placebo will be decided randomly (by chance, like flipping a coin). In this study, 1 out of every 2 subjects (50%) will receive leriglitazone and 1 out of every 2 subjects (50%) will receive placebo. To make this study fair, you and the study doctor will not be told which treatment you will receive, this is called “blinding”. In the open-label extension, all subjects will receive leriglitazone.

Principal Investigator: Troy Lund
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: SITE00001908
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Inclusion Criteria:

• diagnosis of progressive cerebral adrenoleukodystrophy (cALD), defined as GdE with brain lesions
• bone marrow transplantation (HSCT) is not recommended patient is not willing to undergo HSCT
• no major cognitive impairment
• see link to clinicaltrials.gov for additional inclusion criteria
Exclusion Criteria:

• or treatment with ex-vivo gene therapy (eli-Cel).
• known type 1 or type 2 diabetes
• see link to clinicaltrials.gov for additional exclusion criteria
Conditions: Rare Diseases
Keywords: Clinics and Surgery Center (CSC), CEREBRAL ADRENOLEUKODYSTROPHY, cALD
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FAM (Follower, Action Plan, and Remote Monitoring) Intervention to Reduce Severe Hyperglycemia in Adults with Type 1 Diabetes Mellitus at Risk for Diabetic Ketoacidosis (Aim 3)

People with diabetes and their “Follower” (family member, friend, or caregiver) will participate together in 4+ sessions with a Certified Diabetes Care and Education Specialist over 90 days. Sessions can be completely virtual (via Zoom) or in person. Participants will receive a personalized Diabetes Action Plan to help navigate the challenges of living with diabetes. The “Follower” (family member, friend, or caregiver) will “follow” blood sugar data in real-time and assist their care partner with diabetes to “troubleshoot” using the Diabetes Action Plan.

Principal Investigator: Jacob Kohlenberg
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: STUDY00020104
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Inclusion Criteria:

• ages 18 to 65
• people with Type 1 Diabetes (T1DM) for at least 1 year
• HbA1C between 7.5% and 14.0%
• "Follower" (family member, friend, or caregiver who is at least 18 years old), willing to participate in the study and follow glucose data and has no self-reported cognitive impairment
Exclusion Criteria:

• active treatment with a sodium-glucose cotransporter-2 inhibitor or planning to start a sodium-glucose cotransporter-2 inhibitor in the next 6 months
• active cancer with the exception of non-melanoma skin cancer
• receiving hospice care
Conditions: Diabetes & Endocrine
Keywords: T1DM, Type 1 Diabetes
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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.

Principal Investigator: Christine Conelea
Age Group: Not specified
This study is NOT accepting healthy volunteers
IRB Number: STUDY00020646
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Inclusion Criteria:

• 12 to 21 years old
• right-handed
• currently have OCD symptoms
Exclusion Criteria:

• inability to have a MRI
• left-handed
• study staff will review additional exclusion criteria
Conditions: Brain & Nervous System, Children's Health, Mental Health & Addiction
Keywords: Obsessive-compulsive disorder, OCD, psychology, therapy, TMS, transcranial magnetic stimulation
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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.

Principal Investigator: Lisa Chow
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: STUDY00014853
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Inclusion Criteria:

• 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
Exclusion Criteria:

• women who are pregnant or are planning to become pregnant
• eating disorders
Conditions: Diabetes & Endocrine
Keywords: Type 2 diabetes, intermittent fasting, caloric restriction, time restricted eating
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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.

Principal Investigator: Emily Nagel
Age Group: Up to 18 years old
This study is NOT accepting healthy volunteers
IRB Number: STUDY00016926
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Inclusion Criteria:

• 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
Exclusion Criteria:

• 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
Conditions: Children's Health, Women's Health
Keywords: Breast Milk, Maternal Stress, Neurodevelopmental and Feeding, Preterm baby, Preterm feeding
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MT2024-06D: Phase 1/2 Study of Donor-Derived Anti-CD33 Chimeric Antigen Receptor Expressing T Cells (VCAR33) in Patients with Relapsed or Refractory Acute Myeloid Leukemia After Allogeneic Hematopoietic Cell Transplantation

To determine the safety and maximum tolerated dose (MTD) of VCAR33 in patients with relapsed or refractory acute myeloid leukemia (R/R AML) after allogeneic hematopoietic cell transplantation (alloHCT)

Principal Investigator: Joseph Maakaron
IRB Number: STUDY00021822
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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.

Principal Investigator: Silvia Balbo
Age Group: 18 years and over
This study is also accepting healthy volunteers
IRB Number: STUDY00012972
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Inclusion Criteria:

• 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}
Exclusion Criteria:

• Tobacco or nicotine users
Conditions: Prevention & Wellness
Keywords: Alcohol, Fanconi Anemia, drinking
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GLNE 007 Evaluation of Stool Based Markers for the Early Detection of Colorectal Cancers and Adenomas

The purpose of this study if to determine if stool or blood can be used to detect colon cancers as early or earlier than colonoscopy. The researchers plan to use these samples to learn about specific proteins (also known as biomarkers) that may indicate colon polyps, colon cancer or an increased risk of developing colon cancer. In order to learn more about preventing and detecting colon and rectal cancer, we are collecting samples from subjects with cancer, adenomas, and colonoscopies who may be at risk for polyps.

Principal Investigator: Paolo Goffredo
Age Group: 18 years and over
This study is also accepting healthy volunteers
IRB Number: SITE00001813
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Inclusion Criteria:

• at least 18 years old
• able to tolerate giving a blood specimen of up to 60 cc
• willing to collect 1-2 stool samples and prepare a Fecal Immunochemical Test (FIT)
• people who have untreated colon cancer OR have previously removed adenomas, OR have a family history of colon cancer OR have a current positive screening stool test in the past 12 months that hasn't been evaluated
• Healthy Controls: have no history of finding polyps, no family history, or negative colorectal cancer screening test (if performed) within past 12 months
Exclusion Criteria:

• people who have had surgery, radiation, or chemotherapy for their current colorectal cancer or any other cancer
• history or clinically active Inflammatory Bowel Disease
• HIV or chronic active viral hepatitis
• history of cancer in the past 3 years (except minor skin, cervical, or endometrial)
• active chemotherapy or radiation treatment for any purpose
Conditions: Cancer, Digestive & Liver Health
Keywords: Colon Cancer, Colon Cancer, Colon Cancer Screening, Colorectal Cancer
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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.

Principal Investigator: Robert McGovern, MD
Age Group: 18 years and over
This study is also accepting healthy volunteers
IRB Number: STUDY00009709
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Exclusion Criteria:

• any neurological disease
• history of vertigo
• dementia of sufficient severity to impair the ability to make decisions
Conditions: Brain & Nervous System
Keywords: Balance, Movement, Parkinson's Disease, D2D
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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.

Principal Investigator: Kamakshi Lakshminarayan
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: STUDY00018765
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Inclusion Criteria:

• 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
Exclusion Criteria:

• 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
Conditions: Brain & Nervous System, Community Health, Heart & Vascular
Keywords: blood pressure, caregiving, dementia, Hypertension, memory, Mild cognitive impairment
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Liver Collection Study

This is a study of individuals older than 18, undergoing abdominal procedures in which the liver is accessible, and are amenable to liver samples being collected during their surgical procedure, with the option to participate in a specialized scan that can provide information on liver health, stiffness, and fat content. This study is trying to figure out how senescent (aging) cells in the liver are related to an individual's health status and better understand the association between these cells and different metabolic diseases.

Principal Investigator: Sayeed Ikramuddin
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: STUDY00013764
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Inclusion Criteria:

• Age 18 years or older
• Undergoing abdominal surgical procedure with general anesthesia
Exclusion Criteria:

• Pregnancy or nursing
• Physician may exclude
Conditions: Diabetes & Endocrine, Digestive & Liver Health, Prevention & Wellness
Keywords: abdominal surgery, liver biopsy
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Profiling of Adipose Tissue Depots and Immune Correlates

This is a study of individuals older than 18, undergoing abdominal surgery, and are amenable to fat samples being collected during their surgical procedure, with the option to participate in other tests that can provide information on insulin sensitivity and fat distribution. This study is trying to figure out how fat tissue is related to an individual's health status and health conditions, and the analysis of the aging of cells that make up the human body.

Principal Investigator: Sayeed Ikramuddin
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: STUDY00009134
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Inclusion Criteria:

• Age 18 years or older
• Undergoing abdominal surgical procedure with general anesthesia
Exclusion Criteria:

• Pregnancy or nursing
• Exclusion at the discretion of attending physician or Eligibility Committee
Conditions: Digestive & Liver Health, Diabetes & Endocrine, Prevention & Wellness
Keywords: abdominal surgery, fat collection
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A Multicenter Observational Study of GammaTile Surgically Targeted Radiation Therapy (STaRT) in Intracranial Brain Neoplasms

We are studying the effectiveness of GammaTiles TM that are placed during surgery done to remove brain tumors. GammaTiles TM are used to deliver radiation to the surgical area in the brain. We are collecting information about the effectiveness and side effects and will compare to people who receive the usual treatment.

Principal Investigator: Lindsey Sloan
Age Group: Not specified
This study is NOT accepting healthy volunteers
IRB Number: SITE00000958
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Inclusion Criteria:

• undergo maximum safe resection of intracranial neoplasm(s) AND implantation of GammaTiles.
Exclusion Criteria:

• unable to have pre-operative and post-operative imaging for disease and implant assessment
• major medical or psychiatric illness (study staff will review)
• unable to speak and read English
Conditions: Brain & Nervous System, Cancer
Keywords: Brain Tumor
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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.

Principal Investigator: Alexander Boucher
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: STUDY00018692
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Inclusion Criteria:

• 18 to 24 years old
• diagnosis of sickle cell anemia
• transitioning to adult care at UMMC from pediatric care for SCD
Exclusion Criteria:

• unable to speak and write English
• have had more than 2 visits as a new patient in the adult UMMC sickle cell clinic
Conditions: Blood Disorders, Mental Health & Addiction
Keywords: SCD, sickle cell, sickle cell anemia, Clinics and Surgery Center (CSC)
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SPR001-205 A Phase 2 Study to Evaluate the Safety, Pharmacokinetics,;and Exploratory Pharmacodynamics of SPR001 (Tildacerfont) in Children: Aged 6 to 17 Years with Congenital Adrenal Hyperplasia

The goal of this study is to test the safety and effectiveness of tildacerfont in children with congenital adrenal hyperplasia (CAH). When a child is enrolled in the study, in addition to taking the study drug (tildacerfont), he or she will continue to take his or her standard glucocorticoid doses. A part of the study will be to test different doses of the study drug and to measure adrenal hormones at each visit. Children will be in the study for 18 weeks and will have to visit the study clinic 5 times.

Principal Investigator: Kyriakie Sarafoglou
Age Group: Up to 18 years old
This study is NOT accepting healthy volunteers
IRB Number: SITE00001409
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Inclusion Criteria:

• age 2 to 17 years
• childhood diagnosis of classic congenital adrenal hyperplasia (CAH) a genetic mutation in CYP21A2
• currently taking steroids to treat CAH and on a stable dose for 1 month or more
Exclusion Criteria:

• clinically significant unstable medical or mental health condition (study staff will review)
• females who are pregnant or nursing
• unable to swallow medications
Conditions: Rare Diseases, Children's Health
Keywords: CAH, Congenital Adrenal Hyperplasia
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See this study on ClinicalTrials.gov

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.

Principal Investigator: Ziad Nahas
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: SITE00000818
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Inclusion Criteria:

• 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
Exclusion Criteria:

• 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
Conditions: Mental Health & Addiction
Keywords: Depression, Major depression

Transcatheter Mitral Valve Replacement with the Medtronic Intrepid™ TMVR System in patients with severe symptomatic mitral regurgitation – APOLLO Trial (APOLLO)

The purpose of this study is to determine if replacing the mitral valve without open-heart surgery is as safe and effective as standard mitral valve surgery in patients with similar medical conditions. This system allows a bioprosthetic mitral valve (investigational valve) to be implanted through a long, thin, flexible tube that is inserted through an incision in the side of the chest or through an incision made in the groin area and through a vein in the leg. Participation in the study is expected to last approximately 5 years from the day the valve is implanted.

Principal Investigator: Greg Helmer
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: STUDY00017497
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Inclusion Criteria:

• diagnosis of moderate or severe mitral value regurgitation with symptoms
• multidisciplinary heart team thinks patient is not able to have treatment an approved transcatheter repair or conventional mitral valve procedure
Exclusion Criteria:

• prior transcatheter mitral valve procedure with device currently implanted
• left ventricular ejection fraction <30%
Conditions: Heart & Vascular
Keywords: Clinics and Surgery Center (CSC), Intrepid, Mitral valve, Mitral Valve Replacement, TAVR

Udall P1A4

Through this research, the study staff hopes to better understand how DBS works and to define the optimal site in the brain for DBS treatment for Parkinson’s Disease. You will be asked to come for one study visit where you will perform some physical and mental tasks while on and temporarily off your medications and DBS treatment. Participation in this research study will take 7-8 hours.

Principal Investigator: Jerrold Vitek
Age Group: Not specified
This study is NOT accepting healthy volunteers
IRB Number: STUDY00019735
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Inclusion Criteria:

• at least 10 years old
• diagnosis or suspected diagnosis of Parkinson's disease, Essential Tremor, or Dystonia
• implanted Deep Brain Stimulator (DBS)
• have a 7T MRI
Exclusion Criteria:

• history of dementia
• women who are pregnant or breastfeeding
• other exclusion criteria (study staff will review)
Conditions: Brain & Nervous System
Keywords: DBS, Dystonia, Essential Tremor, ET, Movement Disorders, Parkinson's, Parkinson's Disease, PD
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See this study on ClinicalTrials.gov