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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.

438 Study Matches

Registry Study of Childhood Cancer in Minnesota

The aim of this study is to obtain newborn blood spots (NBS) and tumor specimens for children and adolescents diagnosed with malignant neoplasms.

Principal Investigator: Erin Marcotte
Age Group: Not specified
This study is also accepting healthy volunteers
IRB Number: STUDY00018811
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Sex: Male or Female
Age Group: Not specified
This study is also accepting healthy volunteers
Inclusion Criteria:

• 0 to 21 years of age
• child diagnosed with any type of tumor or cancer
• born in a state that banks newborn blood spots
• able to understand English or Spanish
• parents or siblings may also contribute specimens
Conditions: Cancer
Keywords: blood specimen, cancer, tumor
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The Lung Cell Study (TLC)

The purpose of our research study is to increase our understanding on the human lung immune response to infection. We aim to use this knowledge to develop novel approaches on the prevention and treatment of lung infections. To accomplish this, we plan to obtain cells from the airways and blood of healthy volunteers to perform immune experiments.

Principal Investigator: Monica Campo Patino
Age Group: 18 years and over
This study is also accepting healthy volunteers
IRB Number: STUDY00016947
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Sex: Male or Female
Age Group: 18 years and over
This study is also accepting healthy volunteers
Inclusion Criteria:

• healthy volunteers without systemic or respiratory disease
• non-smokers or former smokers who quit more than 6 months ago (including marijuana)
• ages 18-50
• preferred but not required: have lived in countries in Africa, Latino America or South East Asia
• preferred but not required: history of positive tuberculosis (TB) skin or blood test
Exclusion Criteria:

• recent illness, bleeding disorders, or a history of heart, lung, or systemic disease
• weakened immune system or use of immunosuppressant medication
• use of inhaled substances in the past six months or history of heavy smoking
• allergy or prior adverse reaction to lidocaine, midazolam, or fentanyl
• pregnancy
Conditions: Immune Diseases, Infectious Diseases, Respiratory System
Keywords: blood, blood donation, blood draw, bronchoscopy, Healthy Volunteer, TB, TLC, Tuberculosis
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Rectus sheath block with liposomal bupivacaine versus thoracic epidural analgesia for pain control following pancreatoduodenectomy: a prospective, randomized, non-inferiority trial

In this study, we are comparing two different numbing techniques performed by anesthesiologists. Patients in the study are randomly selected to receive one or the other type of numbing injection. One group of patients will receive an epidural, which is a numbing injection done in the back, similar to that which women receive when they give birth. The other group of patients will receive a rectus sheath block, which is a numbing injection done on the abdomen. Both of these types of numbing injections are performed regularly by our anesthesiologists at the University.

Principal Investigator: James Flaherty
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: STUDY00019488
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Sex: Male or Female
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
Inclusion Criteria:

• pancreaticoduodenectomy at the University of Minnesota
Exclusion Criteria:

• chronic opioid use
• women who are pregnant
• see link to clinicaltrials.gov for complete exclusion criteria
Conditions: Cancer
Keywords: duodenal cancer, pancreatic cancer
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A seamless, Phase 1b/2 multiple ascending dose/proof of concept study of XTMAB-16 in patients with pulmonary sarcoidosis with or without extrapulmonary manifestations

XTMAB-16 is a new, experimental drug and is part of a group of drugs known as tumor necrosis factor alpha (TNF α) inhibitors. TNF is a protein in your body that causes inflammation. TNF α inhibitors work by suppressing part of the immune response along with reducing inflammation. We are conducting this research study to see if XTMAB-16 will help in the treatment of pulmonary sarcoidosis.

Principal Investigator: David Perlman
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: STUDY00020802
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Sex: Male or Female
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
Inclusion Criteria:

• Diagnosis of pulmonary sarcoidosis with some respiratory symptoms
• Must be taking 7.5 to 25 mg of prednisone daily and will to taper down dose
• Must be on an additional medication for the treatment of sarcoidosis
• Please contact umnsarc@umn.edu if you have any questions
Exclusion Criteria:

• Pregnancy or breast-feeding
Conditions: Breathing, Lung & Sleep Health, Rare Diseases, Rare Diseases, Respiratory System
Keywords: Clinics and Surgery Center (CSC), Sarcoidosis
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MT2022-45 Primary Immune Regulatory Disorders (PIRD): Longitudinal Study of Clinical Presentation, Treatment and Outcomes

Primary Immune Regulatory Disorders (PIRD disorders) are a group of diseases that cause the immune system to function abnormally and cause infections, autoimmunity or inflammation that can begin early in life. PIRD is usually caused by changes in genes in DNA. Researchers are trying to learn what types of medical problems patients with PIRD have and how these respond to treatment. Researchers also want to learn which genes cause PIRD and how it can cause the medical problems of PIRD.

Principal Investigator: Christen Ebens
Age Group: Not specified
This study is NOT accepting healthy volunteers
IRB Number: SITE00001766
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Sex: Male or Female
Age Group: Not specified
This study is NOT accepting healthy volunteers
Inclusion Criteria:

• age 0 to 99 years
• diagnosis of immune-mediated bowel disease affecting at least one segment of the bowel
• evidence of interstitial lung disease (ground-glass opacities) or pulmonary nodules/cysts
• decreased lung function
• additional inclusion and exclusion criteria apply (study staff will review)
• also enrolling parent, sibling, or child of eligible participants
Exclusion Criteria:

• documented HIV infection
Conditions: Rare Diseases
Keywords: Clinics and Surgery Center (CSC)
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Inhibitory Mechanisms of Negative Urgency in Adolescent Suicidal Behavior

This study is being done to better understand how the brain and impulsive decision-making are connected to depression and suicidal behaviors in people ages 13-21. Participants will complete clinical assessments, behavioral measures, undergo an MRI scan and complete transcranial magnetic stimulation with electroencephalography (TMS-EEG). There will be follow-ups at 6 and 12 months.

Principal Investigator: Kathryn Cullen
Age Group: Not specified
This study is NOT accepting healthy volunteers
IRB Number: STUDY00020551
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Sex: Male or Female
Age Group: Not specified
This study is NOT accepting healthy volunteers
Inclusion Criteria:

• 13-21 years of age
• current unipolar depressive episode
• lifetime history of suicidal ideation OR suicidal behavior
Exclusion Criteria:

• lifetime history of psychosis, hypomania, mania
• historical diagnosis of autism spectrum disorder or intellectual disability
• pregnancy
• neurological disorders
• MRI contraindications (metal implants, fragments or devices)
Conditions: Brain & Nervous System, Children's Health, Mental Health & Addiction
Keywords: adolescents, Depression, mental health, suicide, teens

RCT01437: Proactive infliximab optimization using a pharmacokinetic dashboard versus standard of care in patients with inflammatory bowel disease: The OPTIMIZE Trial

The purpose of this study is to find out if using a computer program (called iDose) to guide infliximab dosing is more effective and safer than using standard infliximab dosing over 52 weeks. All patients in this study will be receiving infliximab as part of their medical care, this study is only looking at two different methods of determining the dose and timing of administration.

Principal Investigator: Byron Vaughn
Age Group: Not specified
This study is NOT accepting healthy volunteers
IRB Number: STUDY00013632
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Sex: Male or Female
Age Group: Not specified
This study is NOT accepting healthy volunteers
Inclusion Criteria:

• 16 to 80 years of age
• diagnosis of moderate to severe Crohn's disease (CD) or Ulcerative colitis
• physician intends to prescribe infliximab for treatment
• have not previously taken infliximab
Exclusion Criteria:

• pregnant or breastfeeding
• complications of inflammatory bowel disease (IBD) such as abscess, need for ostomy (study staff review)
• current infection in last 6 months
• other significant medical conditions (heart, lungs, liver, endocrine etc.)
Conditions: Digestive & Liver Health
Keywords: Clinics and Surgery Center (CSC), Crohn's disease
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See this study on ClinicalTrials.gov

REACT-AF: The Rhythm Evaluation for AntiCoagulaTion with Continuous Monitoring of Atrial Fibrillation (REACT-AF)

This research is being done to assess whether it is safe and effective to stop oral anticoagulation medications (a blood-thinning medication) during prolonged periods of normal heart rhythm in participants with infrequent episodes of atrial fibrillation (AF).

Principal Investigator: Lin Yee Chen
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: SITE00002070
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Sex: Male or Female
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
Inclusion Criteria:

• history of symptomatic or asymptomatic paroxysmal or persistent atrial fibrillation (AF) and a moderate risk of stroke
Exclusion Criteria:

• documented prior stroke (ischemic or hemorrhagic) or transient ischemic attack (TIA)
• reversible causes of AF (e.g., cardiac surgery, pulmonary embolism, untreated hyperthyroidism).
Conditions: Heart & Vascular
Keywords: AF, Clinics and Surgery Center (CSC), Stroke, AFSW, REACT
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See this study on ClinicalTrials.gov

COCOA (COCOA-PAD II)

Few medical treatments are available to improve walking ability in patients with PAD. This research study will help determine the effects of cocoa flavanols on walking ability in people with blockages in their leg arteries. Cocoa flavanols are a type of plant nutrient found in cocoa beans. These supplements are available over-the-counter at drugstores.

Principal Investigator: Diane Treat-Jacobson
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: SITE00001135
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Sex: Male or Female
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
Inclusion Criteria:

• Age 55 and older
• Presence of peripheral artery disease (PAD). PAD will be defined as either an ABI <= 0.90 at baseline or vascular lab evidence of PAD or angiographic evidence of PAD.
Exclusion Criteria:

• Unable to tolerate study pills
• Inability to walk or requiring a walker
Keywords: cocoa, intercede, pad, peripheral artery disease, prove
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See this study on ClinicalTrials.gov

The women with inflammatory Bowel Disease and Motherhood: A Prospective Registry

This is a prospective questionnaire study that will examine the impact of IBD and its surgical treatments on fertility in women with IBD of reproductive age (18-45). Women with IBD who are attempting to get pregnant within the next year will answer questionnaires about their general, surgical and reproductive health, conception history and sexual partner information. This will help identify risk factors predictive of fertility outcomes and early fetal loss, determine time to conception, and assess efficacy of fertility services including in vitro fertilization.

Principal Investigator: Eugenia Shmidt
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: STUDY00003958
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Sex: Female
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
Inclusion Criteria:

• age 18-45 years
• diagnosis of inflammatory bowel disease (IBD)
• not currently pregnant or trying to get pregnant
• desire to become pregnant within the next 12 months (may become pregnant while in the study)
Exclusion Criteria:

• prior pelvic surgery, including surgery of the cervix, ovary, uterus or fallopian tubes
• known female sterility
• known male infertility factors in partner
Conditions: Digestive & Liver Health, Women's Health
Keywords: Fertility, IBD, Inflammatory Bowel Disease
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OptimICE-PCR: De-Escalation of Therapy in Early-Stage TNBC Patients Who Achieve pCR After Neoadjuvant Chemotherapy With Checkpoint Inhibitor Therapy

This trial compares the effect of pembrolizumab to observation for the treatment of patients with early-stage triple-negative breast cancer who had a complete response after preoperative chemotherapy in combination with pembrolizumab. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. This trial may help researchers determine if observation will result in the same risk of cancer coming back as pembrolizumab after surgery.

Principal Investigator: Jocelin Huang
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: MMCORC077
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Sex: Male or Female
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
Inclusion Criteria:

• walking and able to do all selfcare but unable to carry out any work activities; up and about more than 50% of waking hours
• diagnosis of Triple Negative Breast Cancer (TNBC) without any remaining disease after neoadjuvant chemotherapy with pembrolizumab for at least 6 cycles
• no more than 12 weeks between surgery and starting the trial
• see link to clinicaltrails.gov for complete inclusion and exclusion criteria
Exclusion Criteria:

• stage IV (metastatic) breast cancer
• women who are pregnant or breast feeding
• history of any prior invasive breast cancer in either breast
• active liver disease
• medical conditions that require chronic systemic steroids (>10 mg prednisone daily or equivalent) or any other form of immunosuppressive medications and has required such therapy in the last two years
Conditions: Cancer
Keywords: TNBC, Triple Negative Breast Cancer
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See this study on ClinicalTrials.gov

CLINPRT-7: Intermediate Patient Population Expanded Access Protocol for MBP134 for Patients with Sudan Virus Disease (SVD)

The purpose of this open-label Expanded Access Protocol (EAP) is to provide access to MBP134, for treatment of Sudan Virus Disease (SVD). Patients will receive a single IV infusion of 50 mg/kg MBP134. Patients will be monitored and assessed daily through discharge for safety and the incidence of serious adverse events (SAEs), and of all adverse events (AEs) during infusions.

Principal Investigator: Susan Kline, MD
Age Group: Not specified
This study is NOT accepting healthy volunteers
IRB Number: SITE00001888
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Sex: Male or Female
Age Group: Not specified
This study is NOT accepting healthy volunteers
Inclusion Criteria:

• people of any age who have a documented positive RT-PCR for Sudan Virus Disease (SVD) in the last 10 days
• OR a documented positive RT-PCR test for SUDV more than 10 days ago but continue to have symptoms of SVD
• OR acute symptoms compatible with SVD and a close contact with some who has RT-PCR confirmed SVD
• OR Infants born to mothers who have a positive RT-PCR results for SUDV within 10 days of birth or with a documented positive RT-PCR test for SUDV in >10 days but with ongoing symptoms of SVD
• women of who are of child-bearing age must use highly effective contraception for 90 days after receiving the medication
Exclusion Criteria:

• any medical condition that, in the opinion of the physician, would unreasonably increase risk of side effects (study staff will assess)
Conditions: Infectious Diseases, Rare Diseases
Keywords: Sudan Virus Disease, SVD
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Amblyopia Treatment Study (ATS23): A Randomized Trial of Dichoptic Treatment for Amblyopia in Children 4 to 7 Years of Age (ATS23)

Amblyopia (sometimes called 'lazy eye') is reduced vision in one eye caused by abnormal visual development early in life. The weaker (or 'lazy') eye often wanders inward and outward. Amblyopia is the leading cause of reduced vision in children and can lead to blindness if not treated. Treatments for amblyopia are glasses, and if needed, further treatment with part-time patching or penalization with atropine eye drops. Patching or atropine are administered to the stronger eye to force the child to use the weaker (amblyopic) eye. In recent years, an alternative type of therapy has emerged. It is called dichoptic treatment and involves stimulating both eyes simultaneously but with different stimuli. When it was first introduced, it was done in an office-based setting. Home-based technologies utilizing games and movies have been developed and studied to a limited extent in younger children with amblyopia. In this study, we will use a system called Luminopia. It uses a virtual reality headset to view web-based videos in which the contrast of the image seen by the stronger eye is reduced by 15% from that of the weaker eye. Luminopia has been available for use in the U.S. since 2022 and has been approved by the FDA for the treatment of amblyopia in this age group. In a previous large randomized trial, home-based dichoptic movies were shown to be superior to glasses alone but treatment effectiveness compared to patching (the gold standard for treating amblyopia) has not yet been established. If dichoptic therapy using the Luminopia system is confirmed to be at least as effective as patching, it would be an appealing alternative for treating amblyopia in young children, as it shows promise of better adherence and an easier treatment experience for the parent and the child. Children in this study would be randomized 1:1 to either the Patching Group or the Luminopia Group and followed for at least 6 months. Children in the Patching Group will have the option to do the Luminopia treatment after 6 months of patching. They will be followed for an additional 6 months. Thus, their participation will last for a total of 1 year.

Principal Investigator: Raymond Areaux
Age Group: Up to 18 years old
IRB Number: STUDY00022243
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Sex: Male or Female
Age Group: Up to 18 years old
Inclusion Criteria:

• children 4 to 7 years old
• amblyopia (lazy eye) associated with strabismus, anisometropia, or both (previously treated or untreated)
• parent has phone (or access to phone) and is willing to be contacted
Exclusion Criteria:

• prism lenses or need of a prism prescription
• currently wearing bifocals
• known skin reactions to patch or bandage adhesives
• history of light-induced seizures
Conditions: Children's Health, Vision & Eyes
Keywords: Amblyopia, Lazy Eye
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See this study on ClinicalTrials.gov

A US Multi-center, Prospective, Non-interventional, Long-term, Effectiveness and Safety Study of Patients Treated with SKYTROFA (lonapegsomatropin) (SkybriGHt) (SkybriGHt)

Skytrofa is approved in the U.S. for sale and use in children with growth hormone deficiency (GHD). This study is being done to find out how safe and useful Skytrofa is for long-term treatment. A child’s care will follow the normal treatment practices at the clinic. There is no new treatment or medicine involved and no additional visits will be performed.

Principal Investigator: Brad Miller, MD, PhD
Age Group: Up to 18 years old
This study is NOT accepting healthy volunteers
IRB Number: SITE00002031
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Sex: Male or Female
Age Group: Up to 18 years old
This study is NOT accepting healthy volunteers
Inclusion Criteria:

• 1 to 18 years old
• on treatment with SKYTROFA (lonapegsomatropin)
Exclusion Criteria:

• participating in any interventional clinical study
Conditions: Rare Diseases
Keywords: growth hormone, growth hormone deficiency
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Self-Weighing for Weight Management in Adolescents Seeking Obesity Treatment: A Randomized Pilot

This study will test whether adding in daily weighing (5-7 days per week) is helpful in weight loss. In adults, it has been found to be helpful to have individuals who are obese to be more successful with their weight loss efforts if they weigh themselves at home every day. We want to see if this could be helpful in children as well. This research will last for about 12 weeks (3 months).

Principal Investigator: Carolyn Bramante
Age Group: Up to 18 years old
This study is NOT accepting healthy volunteers
IRB Number: STUDY00012679
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Sex: Male or Female
Age Group: Up to 18 years old
This study is NOT accepting healthy volunteers
Inclusion Criteria:

• aged 12 to <18 years
• BMI at the 95th percentile or greater
• weight loss or maintenance determined as the treatment goal by PWMC provider
Exclusion Criteria:

• any unhealthy weight control behaviors
• participation in other PWMC study
• developmental delay
• diagnosis that might cause weight fluctuations in weight
• severe anxiety or depression
Conditions: Children's Health
Keywords: children's health, obesity, weight, weight management
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Development of objective measures for multisensory effects on hearing

Paired sound and electrical stimulation can alter how the brain encodes sounds and the perception of sounds, as shown in emerging evidence from animal studies. The aim of this study is to develop measures for paired stimulation that can be used reliably. These measures assess the following aspects of hearing: basic hearing sensitivity and cochlear health, perception of loudness and pitch, and perception of speech and other complex sounds. This will lead to a greater understanding in the hearing science community about how multisensory stimulation can alter activity in the auditory system and sound perception, which may lead to new techniques for improving hearing disorders.

Principal Investigator: Hubert Lim
Age Group: 18 years and over
This study is also accepting healthy volunteers
IRB Number: STUDY00022175
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Sex: Male or Female
Age Group: 18 years and over
This study is also accepting healthy volunteers
Inclusion Criteria:

• not users of hearing aids or implanted devices
• normal hearing or hearing-impaired, with or without tinnitus
Exclusion Criteria:

• users of hearing aids or implanted devices
Conditions: Ear, Nose & Throat
Keywords: auditory plasticity, Hearing loss, neuromodulation, tinnitus, transcutaneous electrical stimulation
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Visual Perception in Visual Snow Syndrome

This study seeks to understand visual perception in people with Visual Snow Syndrome and how this relates to brain function.

Principal Investigator: Michael-Paul Schallmo
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: STUDY00014113
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Sex: Male or Female
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
Inclusion Criteria:

• Between 18 - 60 years old
• Good general physical health
• No history of other neurological disorders or problems
• Fluent in English
Conditions: Vision & Eyes
Keywords: Visual snow, visual snow syndrome
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See this study on ClinicalTrials.gov

Influence of Exercise on the Gut Microbiome of Overweight and Obese Adults with Prediabetes

We are looking at how an 8-week exercise program of walking for 30-45 minutes 3 times/week affects the body. This study is for people who are prediabetic and overweight or obese. We will compare the exercise group to a group that didn’t participate in the exercise to see if there are differences in gut microbes, body measurements, and blood work.

Principal Investigator: Ryan Demmer
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: STUDY00009136
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Sex: Male or Female
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
Inclusion Criteria:

• 30-64 years old
• classified as overweight or obese with BMI greater than 25 kg/m2
• physician diagnosed as pre-diabetic or HbA1c value of 5.7 - 6.4% obtained during study screening
• currently exercise less than 100 minutes per week
• physically able to exercise
• no antibiotics taken for at least 45 days
• weight has been stable for the last 6 months (less than 10% change)
• willing to maintain current diet and exercise levels unless changed by the study
Exclusion Criteria:

• current gastrointestinal illness
• taking metformin or other medications for high blood sugar
• history of bariatric surgery
• pregnant or breast feeding
Conditions: Diabetes & Endocrine
Keywords: Prediabetes, elevated blood glucose, impaired glucose, blood sugar, obesity, Hemoglobin A1c, exercis
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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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Sex: Male or Female
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
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: MAIS, ALS, Amyotrophic Lateral Sclerosis, Primary Lateral Sclerosis, Clinics and Surgery Center (CSC)
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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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Sex: Male or Female
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
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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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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Sex: Male or Female
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
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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Sex: Male or Female
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
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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See this study on ClinicalTrials.gov

Genetics of Developmental Disorders - Data and Specimen Repository (Le-Na)

This project is a data and specimen repository for developmental disorders. Participants provide biological samples and permission to store their health-related data. The purpose is collect and manage these materials for use in biomedical research related to developmental disorders.

Principal Investigator: Charles Billington Jr.
Age Group: Not specified
This study is NOT accepting healthy volunteers
IRB Number: STUDY00011194
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Sex: Male or Female
Age Group: Not specified
This study is NOT accepting healthy volunteers
Inclusion Criteria:

• All ages
• Individuals with a developmental disorder (mostly but not exclusively developmental brain disorders)
• Parents and other selected relatives of individuals with developmental disorders
Conditions: Brain & Nervous System, Rare Diseases, Children's Health
Keywords: Genetic disorders, developmental brain disorders, developmental disorders
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See this study on ClinicalTrials.gov

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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Sex: Male or Female
Age Group: Up to 18 years old
This study is also accepting healthy volunteers
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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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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Sex: Male or Female
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
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: aging, blood pressure, caregiving, dementia, Hypertension, memory, Mild cognitive impairment
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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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Sex: Male or Female
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
Inclusion Criteria:

• 18 to 28 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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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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Sex: Male or Female
Age Group: Up to 18 years old
This study is NOT accepting healthy volunteers
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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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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Sex: Male or Female
Age Group: 18 years and over
This study is also accepting healthy volunteers
Inclusion Criteria:

• Alcohol drinkers of Eastern Asian descent who experiences flushing (reddening or warming of face and chest) 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, flushing
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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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Sex: Male or Female
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
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: Clinics and Surgery Center (CSC), Depression, Major depression

Diaphragmatic Breathing Exercises for post-COVID-19 Diaphragmatic Dysfunction (DD)

There is evidence that dysfunction of the diaphragm following COVID infection that leads to the shortness of breath and chest tightness. The diaphragm is the main muscle of respiration. This study involves muscle stretching of the diaphragm and associated muscles to improve the quality of respiration. Half of the participants will receive PT twice a week, for 12 weeks, for 1 hour (in person) and a half hour via telehealth. A control group will undergo traditional treatment as recommended by your provider.

Principal Investigator: Farha Ikramuddin
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: STUDY00017641
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Sex: Male or Female
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
Inclusion Criteria:

• age 18 and above
• PCR positive 4 weeks prior to the development of the respiratory symptoms
• new diagnosis of PASC (new-onset symptoms of fatigue, shortness of breath, chest tightness or persistence of symptoms 4 weeks following a positive PCR test for COVID-19)
• did not need hospitalization of 5 days or more and did not need ICU admission
• nose breathers
• symptoms include shortness of breath, chest tightness, and fatigue
Exclusion Criteria:

• pre-existing lung disease such as COPD, IPF, Asthma, Exercise induced Asthma, Lung cancer, or history of Lung transplant
• history of current smoking and pack years of 10
• history of coronary artery disease
• general anxiety disorder
• unable to have full range of motion of the shoulders
• on antidepressants prior to covid-19 infection
• women who are pregnant
• unable to read and speak English
• previously diagnosed severe cognitive deficits such as dementia, developmental defects
• acute medical conditions, psychiatric disorders such as schizophrenia, mania, and psychosis, neurologic disorders such as stroke, Parkinson’s disease and Multiple sclerosis
Conditions: Respiratory System
Keywords: COVID-19, shortness of breath, cough
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