
Search Results
A Prospective, Multi-Institutional Phase II Trial Evaluating Temozolomide vs. Temozolomide and Olaparib for Advanced Pheochromocytoma and Paraganglioma
This trial studies how well the addition of olaparib to the usual treatment, temozolomide, works in treating patients with neuroendocrine cancer (pheochromocytoma or paraganglioma) that has spread from where it first started (primary site) to other places in the body (metastatic) or cannot be removed by surgery (unresectable).
• at least 12 years old
• diagnosis of advanced (metastatic or unresectable primary) pheochromocytoma or paraganglioma
• prior treatment with other somatostatin analog, chemotherapy, radiotherapy
• at least ambulatory and able to do all self care but unable to carry out any work activities; up and about more than 50% of waking hours
• no known medical condition causing an inability to swallow oral medications
• see link to clinicaltrials.gov for complete inclusion criteria
• women who are pregnant or breastfeeding
A Phase 2 Randomized, Placebo-controlled Study of the Safety and Efficacy of Obeldesivir to Treat Nonhospitalized Adults With Acute Respiratory Syncytial Virus (RSV) Infection
We are running this research study to learn about Obeldesivir (ODV) for people with RSV infection who have not been hospitalized for treatment. People in the study will take ODV or placebo (an inactive substance) for up to 5 days.
• at least 1 of the following risk factors for severe RSV disease: at least 60 years old, moderate or severe COPD, asthma with at least one exacerbation during the proceeding year, significant lung or heart disease
• positive test for RSV in the last 3 days
• if age is the only risk factor, must not have received the RSV vaccine
• see link to clinicaltrials.gov for complete inclusion & exclusion criteria
• in the hospital, or expect to need hospitalization
• previous infection and/or hospitalization for RSV during the current respiratory virus season
• positive for influenza A or B virus, and/or severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in the past week
• history of cystic fibrosis
• require dialysis, known history of moderate or severe renal impairment
• women who are pregnant
A Phase 1B and randomized phase 2 trial of megestrol acetate with or without ipatasertib in recurrent or metastatic endometrioid endometrial cancer
The study is divided into two portions. In the first phase, we want to test the safety of a drug called ipatasertib, by testing different doses of the drug to see which dose is safer for people when given in combination with a fixed dose of a drug called megestrol acetate (MA). In Phase II, we are studying how safe the treatment is and how well it works. We are doing this study because we want to find out if this approach is better or worse than the usual approach for endometrial cancer.
• grade 1 or 2 endometrioid endometrial cancer that has returned or has spread to other parts of the body (metastatic)
• may have received unlimited prior lines of treatment
• able to walk, care for self, and active at least 50% of the day
• able to swallow oral medications
• contact study staff for additional requirements
• prior treatment with an AKT inhibitor
• women who are pregnant or breast feeding
• other medical or mental health diseases (study staff will review)
A Phase 3 Randomized, Placebo-controlled, Double-blind Study to Evaluate the Efficacy and Safety of BBP-418 (ribitol) in Patients with Limb Girdle Muscular Dystrophy 21 (LGMD21) (Fortify)
This study will use BBP-418 study drug in patients with LGMD to assess the clinical biomarkers, efficacy and safety of BBP-418 during the 36 months treatment phase.
• 12 to 60 years of age
• genetically confirmed diagnosis of limb girdle muscular dystrophy
• have clinical symptoms of weakness
• weight at least 30 kg (66 lbs.)
• willing to use a highly effective method of birth control until 12 weeks after last dose of study medication
• any significant medical or mental health diagnosis including abnormal lab values (study staff will review)
• surgery for scoliosis or other indication planned during the time of the study
• use of ribose or other sugar alcohol-containing supplement within 90 days of staring the study
• use of a systemic corticosteroid for the treatment of muscular dystrophy within 90 days of starting the study
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.
• 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
• prism lenses or need of a prism prescription
• currently wearing bifocals
• known skin reactions to patch or bandage adhesives
• history of light-induced seizures
Atherosclerosis Risk in Communities (ARIC) Study - Visits Component (Le-Na)
The purpose of the Atherosclerosis Risk in Communities (ARIC) Study - ARIC Generation 2 research study is to evaluate the link between glucose and heart problems in adults with type 2 diabetes. Heart problems can be common in people with type 2 diabetes. We are interested in measuring your blood sugar (glucose) using a continuous glucose monitor and monitoring your heart rhythm at the same time.
• Have a diagnosis of Type II Diabetes
• Age 50-80 years old
• Be willing to wear a continuous glucose monitor and heart rhythm monitor for two weeks
• Fluent English speaker
• Pacemaker
• Allergy to adhesive tape
• Planning to move away from the Minneapolis area in the next four years
• Live in nursing home/long-term care facility
• diagnosed with dementia or unable to consent for self
A Phase 1/2 Study of the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of Relatlimab Plus Nivolumab in Pediatric and Young Adult Participants with Recurrent or Refractory Classical Hodgkin Lymphoma and Non-Hodgkin Lymphoma Protocol Number: CA224069 (RELATIVITY-069)
CA224069 is an open-label, Phase 1/2 clinical trial of relatlimab + nivolumab in children, adolescents and young adults with Recurrent or Refractory Classical Hodgkin Lymphoma (R/R cHL) and Non-Hodgkin Lymphoma (NHL). Part A will encompass safety and dose determination of relatlimab + nivolumab. Part B will be composed of an expansion cohort of cHL (Cohort 1) and an exploratory assessment in NHL (Cohort 2).
• up to 30 years old
• pathologically confirmed high-risk recurrent/relapsed or refractory (R/R) classical Hodgkin lymphoma (cHL), after non-response to or failure of first-line standard therapy prior to a definitive therapy e.g.high-dose chemotherapy/autologous stem cell transplant (HDCT/ASCT)
• participants with pathologically confirmed R/R NHL after failure or non-response to second line therapy, including but not limited to primary mediastinal B-cell lymphoma, diffuse large B-cell lymphoma (DLBCL), mediastinal gray zone lymphoma (MGZL), anaplastic large cell lymphoma (ALCL), or peripheral T-cell lymphoma (PTCL)
• aggressive B-cell lymphomas subtypes including Burkitt lymphoma (BL), lymphoblastic lymphoma, and NK/T-cell lymphoma/leukemia
• prior autologous stem cell transplantation (HDCT/ASCT)
• see link to clinicaltrials.gov for additional exclusion criteria
A US Multi-center, Prospective, Non-interventional, Long-term, Effectiveness and Safety Study of Patients Treated with SKYTROFA (lonapegsomatropin) (SkybriGHt) (SkybriGHt)
Skytrofa is approved in the U.S. for sale and use in children with growth hormone deficiency (GHD). This study is being done to find out how safe and useful Skytrofa is for long-term treatment. A child’s care will follow the normal treatment practices at the clinic. There is no new treatment or medicine involved and no additional visits will be performed.
• 1 to 18 years old
• on treatment with SKYTROFA (lonapegsomatropin)
• participating in any interventional clinical study
Genetics of Developmental Disorders - Data and Specimen Repository (Le-Na)
This project is a data and specimen repository for developmental disorders. Participants provide biological samples and permission to store their health-related data. The purpose is collect and manage these materials for use in biomedical research related to developmental disorders.
• All ages
• Individuals with a developmental disorder (mostly but not exclusively developmental brain disorders)
• Parents and other selected relatives of individuals with developmental disorders
Imaging Core Aim 2, and Udall Project 2 Aim 2
We are conducting this research to try to find a better way of treating Parkinson's disease, specifically postural instability and gait disturbances (PIGD) by looking at certain brain characteristics using 3T magnetic resonance imaging (MRI.) We think we could discover how to make DBS more effective for such things as postural gait instability and other symptoms of PD. Participants will be asked to come to our research location, walk on a treadmill, and have a 3T MRI.
• at least 21 years old
• already have a MRI-compatible DBS device (Medtronic Percept/Percept RC DBS System) for treatment of Parkinson’s disease
• able to speak English
• women who are pregnant
• extreme claustrophobia
• unable to have a MRI
A Phase II, Multi-center, Open-Label Study to Assess Safety, Tolerability, Efficacy and Pharmacokinetics of R3R01 in Alport Syndrome Patients with Uncontrolled Proteinuria on ACE/ARB Inhibition and in Patients with Primary Steroid-Resistant Focal Segmental Glomerulosclerosis
The main purpose of this study is to check how safe the study drug is and how well your body handles taking it. We will also check if the study drug works to improve your kidney function, if has an impact on your daily life and the amount of the study drug in your blood over a period of time (called pharmacokinetics)
• at least 12 years of age
• for people with Alport Syndrome: confirmed diagnosis by genetic testing and /or kidney biopsy
• for primary Focal Segmental Glomerulosclerosis (FSGS), (without any identifiable cause, and where the FSGS is confirmed by renal biopsy) or FSGS where there is documentation of a genetic mutation in a podocyte protein
• female patients, as well as, female partners of male patients who are of child-bearing potential must be willing to not become pregnant for the complete duration of the study (90 days after the last dose of study medication)
• males (including sterilized subjects) whose female partners have child-bearing potential, must agree to use male contraception (condoms) during the period from the time of signing the informed consent form (ICF) through 90 days after the last dose of study drug
• contact study staff for additional criteria
• uncontrolled diabetes mellitus as evidenced by an HbA1c greater or equal to 11%
• uncontrolled high blood pressure
• moderate or severe liver impairment
• BMI greater than 40
• women who are pregnant or breast feeding
• additional exclusion criteria apply (study staff will review)
Magnetic Resonance Imaging of Osteonecrosis of the Femoral Head
The purpose of this research study is to investigate new magnetic resonance imaging (MRI) methods to better detect and monitor osteonecrosis of the femoral head (ONFH) before and after treatment. ONFH causes injury to the hip joint that can lead to osteoarthritis (the breaking/wearing down of cartilage & tissues within the joint) and the eventual need for a hip replacement. It can be difficult to detect ONFH early on using current medical imaging techniques, which is when treatments may be the most effective. Furthermore, available treatments are not always effective at preventing the progression (spread or growth) of ONFH. This research may benefit others with ONFH by providing more effective medical imaging tools to detect ONFH earlier and inform treatment decisions to increase the chance of stopping or delaying the progression of ONFH and preventing hip osteoarthritis.
• diagnosed with Stage 1 or Stage 2 osteonecrosis of the femoral head (ONFH)
• intend to have core decompression surgery to treat the ONFH
• excluded from having an MRI based on Center for Magnetic Resonance Research (CMRR) safety criteria
• existing implantation of metal device in affected hip
• any health conditions that would pose a challenge for you to participate
• unavailable to undergo follow up MRI 6 months after core decompression treatment
CureGN: Cure Glomerulonephropathy Network Version 2.0
The purpose of CureGN2 is to gather a group of people with glomerular disease to create a source of information and blood and urine samples, so that researchers can easily and effectively study glomerular disease.
• Diagnosis of Glomerular Disease including MCD (minimal change disease), FSGS (focal segmental glomerulosclerosis), MN (membranous nephropathy), or IgAN (immunoglobulin A nephropathy) on first diagnostic kidney biopsy
• First diagnostic kidney biopsy within 5 years of study enrollment
• Access to first kidney biopsy report and/or slides
• All ages
• End Stage Kidney Disease, defined as chronic dialysis or kidney transplant
• Solid organ or bone marrow transplant recipient at time of first kidney biopsy
• Diagnosis of any of the following at the time of first diagnostic kidney biopsy: diabetes mellitus (except gestational or diet controlled), diabetic glomerulosclerosis, systemic lupus erythematosus, HIV infection, active malignancy (except for non-melanoma skin cancer), active Hepatitis B or C infection, defined as positive viral load
Physiological Monitoring of Participants with Chronic Pain Feasibility Study
We are asking people to participate in this study to help us learn more about how physiology (heart rate, sweating, temperature, etc.) of people with pain conditions changes based on perceived pain level. The goal is to use this information to help develop a new medical device designed to help better manage chronic pain, although we are only collecting information at this time, and there will be no treatment provided as part of this study. We expect that people will be in this research study for a maximum of 2 weeks.
• diagnosed with painful peripheral neuropathy
• have experienced pain for at least 3 months
Effects of ziltivekimab versus placebo on morbidity and mortality in patients with heart failure with mildly reduced or preserved ejection fraction and systemic inflammation. (HERMES)
We are looking at a new drug called 'ziltivekimab' to see if it can be used to treat people living with heart failure and inflammation. People will get either ziltivekimab or a placebo (inactive dummy drug). The study drug is an injection given into the fold of the skin on the stomach, thigh or upper arm once every month. People will take the study drug for up to 4 years.
• at least 18 years old
• diagnosis of heart failure
• hospitalization or urgent/unplanned visit with a primary diagnosis of decompensated heart failure which required intravenous diuretic treatment, within the last 9 months prior to starting the study
• left ventricular ejection fraction (LVEF) greater than 40% documented by echocardiogram in the past year
• contact study staff for additional requirements
• myocardial infarction, stroke, unstable angina pectoris, transient ischemic attack, or heart failure hospitalization within 30 days
• planned cardiac procedures (ablation, revascularization
• primary pulmonary hypertension, chronic pulmonary embolism, severe pulmonary disease including COPD etc.)
• women who are pregnant, breast-feeding or planning to get pregnant during the study period.
• contact study staff for additional exclusion criteria
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.
• at least 18 years old
• osteoarthritis of the joint where the bones of the wrist meet the hand (CMC)
• 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
Cochlear Implantation in Children with Asymmetric Hearing Loss or Single-Sided Deafness Clinical Trial
• ages 4 to 14 and 11 months old
• parents and child fluent in English
• parents desire functional hearing in both ears for their child
• severe to profound sensorineural hearing loss in one ear and normal hearing in the other ear
• if older than 5 years, documentation of progressive hearing loss (i.e. passed newborn hearing screening, or significant change in hearing)
• see link to clinicaltrials.gov for complete inclusion and exclusion criteria
• medical condition that contraindicates a cochlear implant, including abnormal hearing nerve
• already using a cochlear implant
Optimization of deep brain stimulation parameters in patients with medically refractory epilepsy
The purpose of this research is to better understand how deep brain stimulation settings can affect the electrical activity in the brain and the frequency of seizures. There are a number of different ways in which the deep brain stimulation electrodes can be programmed to stimulate the brain. This research study uses the implanted battery in the chest to record electrical activity from the brain at different stimulation settings. We then use this electrical activity to determine stimulation settings that are “personalized” to your brain.
myAirvo 3 (High Flow Nasal Therapy; HFNT) for COPD patients in the home - a multi-center randomized controlled trial
The purpose of this research is to learn if home use of high flow nasal therapy (HFNT) increases the time to rehospitalization for people with chronic obstructive pulmonary disease (COPD). Participants will be randomly (by chance; like the flip of a coin) assigned to one of two groups. One group will receive usual medical care for COPD. The other group will receive usual medical care for COPD and use a high-flow nasal therapy device for a minimum of 8 hours daily. Participants will complete daily COPD symptom reports. This research will last for at least 12 months and up to 24 months.
• at least 30 years old
• history of a severe COPD requiring hospitalization in the previous six weeks
• specific requirements for FEV1 and FVC (study staff will review)
• current smokers must refrain from smoking when using supplemental oxygen or the myAirvo-3 device
• women of reproductive are are required to use highly effective contraception for at least 1 month prior to starting the study and agree to use such a method during study participation
• able to read and communicate in English
• current use of positive airway pressure (PAP) therapy; continuous positive airway pressure (CPAP), or non-invasive positive pressure ventilation (NPPV)
• women who are pregnant or breast feeding
• recent upper airway surgery (within the previous month)
• recent head or neck trauma (within the previous month)
• require oxygen greater than at 15 L/min
• inability to tolerate nasal prongs
TMS x DPX
We will examine whether the benefits of brain stimulation on mental functioning can be enhanced if an individual is actively engaging the target brain networks while receiving brain stimulation. The study includes two separate sessions and people will complete either a cognitive task or a perceptual task while we are measuring the change in brain function with EEG. Please fill out the linked screening questionnaire to determine if you are eligible.
• age 18 to 65
• diagnosed with a psychiatric disorder
• potential contraindications to EEG (e.g. visible scalp abrasions, non-removable hair extensions and/or hair styling that would impede proper EEG recording)
• potential contraindication to TMS (as identified by the TMS safety screener)
• any previous adverse reaction to TMS or MRI
• diagnosed with epilepsy or previously experienced a seizure
• diagnosed with a neurological condition, such as stroke or tinnitus
• experienced a head trauma that was diagnosed as concussion
• current use of, or recent withdrawal from, medications that can increase the risk of seizure
• currently pregnant
• any metal in the head (excluding mouth) or have an implanted medical device
Multicenter ALS Imaging Study
The purpose of the study is to test new biomarkers of ALS using MRI scans at 3 Tesla (3T). A biomarker is a measurable characteristic that can be used as an indicator of a particular disease state. Identifying biomarkers in ALS will help test new treatments and may help us make diagnoses earlier.
• for people who have Amyotrophic Lateral Sclerosis (ALS): less than 24 months since symptoms started, and diagnosis of probable or definite ALS
• for people with ALS and healthy volunteers: able to read, write and speak English, and able to have a MRI
• any condition that makes MRI unsafe or if unable to comply with instructions
• healthy volunteers with clinically significant abnormal findings on neurological examination
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.
• 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
• 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
The University of Minnesota Perinatal Health Repository
This research is being done to collect blood and placenta samples to better understand how pregnancy impacts the health of mother and child. The goal of this research is to better understand what causes some pregnancy complications and how this impacts the longer term health of mothers and children.
• pregnant women who are at least 18 years of age and their neonates/children
• seen in Obstetrics and Gynecology Clinics for pre-conception, prenatal or postpartum care
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.
• 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
• diagnosis of idiopathic hypertrophic subaortic stenosis
• untreated severe aortic or mitral stenosis
• heart failure with reduced ejection fraction
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.
• 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
• 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
Transcranial Magnetic Stimulation to Augment Exposure and Response Prevention for Pediatric OCD (NExT)
We are doing this study to see if we can improve the standard treatment for OCD, Exposure with Response Prevention, by pairing it with Transcranial Magnetic Stimulation to the parts of the brain that cause OCD symptoms.
• 12 to 21 years old
• right-handed
• currently have OCD symptoms
• inability to have a MRI
• left-handed
• study staff will review additional exclusion criteria
Time Restricted Eating as a Viable Alternative to Caloric Restriction for Treating Hyperglycemia in a Population with Type 2 (T2DM) diabetes (SFS3)
The purpose of the study is to see how restricting the eating window (called time-restricted eating) might affect eating habits, weight, and blood measures compared to reducing food intake. Time-restricted eating means that people would have a daily 8 hour eating window during which time they can eat whatever they want. Outside of the eating window, people would only take water and your medications. We expect that participants will be in this research study for about 7 months.
• 18 to 65 years old
• overweight/obese and have type 2 diabetes treated with diet or metformin
• BMI between 25-45 kg/m2
• HbA1c between 6.5-8.5%
• self reported weight must be stable (+/- 5 pounds) for at least 3 months prior to the study
• own a smartphone
• women who are pregnant or are planning to become pregnant
• eating disorders
Maternal Stress, Human Milk Composition, and Neurodevelopmental and Feeding Outcomes
This study explores the associations between maternal stress, breastmilk composition, and feeding and neurodevelopment for preterm infants in the NICU and at 4 months corrected age.
• preterm infant born between 28 0/7 and 32 6/7 weeks' gestation
• mother is 18 to 45 years of age at the time of delivery
• mother's BMI between 18.5 to 40 kg/m^2 before pregnancy or at first trimester
• preterm babies with significant health issues at birth
• mothers: a) alcohol consumption >1 drink per week or any tobacco use during pregnancy, b) history/current Type I or II diabetes or gestational diabetes mellitus, c) known congenital metabolic, endocrine disease or congenital illness affecting infant feeding/growth
Dissecting the role of acetaldehyde in oral carcinogenesis
The goal of this study is to better understand how drinking alcohol may lead to oral cancers. Acetaldehyde, a chemical formed when the body breaks down alcohol, is believed to play an important role. This study will measure acetaldehyde and DNA damage levels in the mouth of participants after a low dose of alcohol. The levels will be compared between three groups, all having different degrees of risk for developing oral cancer, and with non-drinkers to identify DNA damage that might be important to cancer formation. We also want to understand how alcohol can affect the bacteria in our mouths and how that might impact oral DNA damage.
• Alcohol drinkers of Eastern Asian descent who experiences flushing (reddening or warming of face) when drinking {ages 21 - 45}
• Alcohol drinkers who have Fanconi Anemia {ages 21+}
• Never drinkers {ages 18 - 45}
• Tobacco or nicotine users
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.
• 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
• 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