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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.
• 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
MT-2018-20: COG AALL1631 - International Phase 3 Trial in Philadelphia Chromosome-Positive Acute Lymphoblastic Leukemia (Ph+ALL) Testing Imatinib in Combination With Two Different Cytotoxic Chemotherapy Backbones
This randomized phase III trial studies how well imatinib mesylate and combination chemotherapy work in treating patients (> 1 year and < 21 years) with newly diagnosed Philadelphia chromosome positive acute lymphoblastic leukemia. Imatinib mesylate may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving imatinib mesylate and combination chemotherapy may work better in treating patients with Philadelphia chromosome positive acute lymphoblastic leukemia.
• >= 1 year (365 days) and =< 21 years at ALL diagnosis
• Diagnosis: Ph+ (BCR-ABL1 fusion): newly diagnosed de novo ALL (B-ALL or T-ALL) or mixed phenotypic acute leukemia (MPAL meeting 2016 WHO definition) with definitive evidence of BCR-ABL1 fusion by karyotype, FISH and/or molecular methodologies. OR
• Diagnosis: ABL-class fusion: newly diagnosed B-ALL with definitive evidence of ABLclass fusions. ABL-class fusions are defined as those involving the following genes: ABL1, ABL2, CSF1R, PDGFRB, PDGFRA.
• see link to clinicaltrials.gov for complete Inclusion Criteria
• known history of chronic myelogenous leukemia (CML)
• ALL developing after a previous cancer treated with cytotoxic chemotherapy
• Down syndrome
• patients with congenital long QT syndrome, history of ventricular arrhythmias or heart block
National Pediatric Cardiology Quality Improvement Collaborative (NPC-QIC) - A Collaborative Initiative to Improve Care of Children with Complex Congenital Heart Disease (NPC-QIC)
This study is being sponsored by the National Pediatric Cardiology Quality Improvement Collaborative (NPC-QIC). We want to learn more about improving the treatment and outcomes for patients who have a diagnosis of a single ventricle, such as Hypoplastic Left Heart Syndrome (HLHS) or similar heart defects.
• up to 15 months old
• newborns diagnosed with HLHS or other univentricular condition
• intended to undergo Norwood procedure
The DART Study
We are interested in learning more about how Transcranial Magnetic Stimulation (TMS) and ketamine affect depressive symptoms. We are most interested in learning how anhedonia (lacking pleasure in life) is changed by these treatments. Patients who have been diagnosed with treatment-resistant depression (TRD) and who are also scheduled to receive ketamine or Transcranial Magnetic Stimulation (TMS) are being recruited for this study. We are looking to enroll a second group of participants into a healthy control group who have not been diagnosed with a psychiatric disorder. This group will have a single 60 minute visit in which computer tasks and surveys will be completed while wearing an electroencephalogram (EEG) head cap to record brain activity.
• criteria for healthy volunteers: age 18 or older and able to read English
• diagnosis or history of depression, bipolar disorder, Generalized Anxiety Disorder, or other psychiatric conditions.
Visual Surround Suppression and Perceptual Expectation Under Psilocybin
Psilocybin is the perception-altering drug found in ‘magic mushrooms’ and we want to learn more about visual perception in people taking psilocybin and how these relate to brain functions. Participants will be given an investigational study drug during 2 visits and asked to come in for a total of 7 study visits. Participants will also be required to refrain from using recreational drugs while enrolled in the study, including, but not limited to, hallucinogens, ketamine, and marijuana.
• 25-65 years of age
• have at least a high school education (GED ok) and able to speak and write English
• experience taking psilocybin
• in good physical and mental health with BMI between 20.0 and 28.0 kg/M2
• have someone who can drive to study sessions at the University of MN
• live within 1 hour driving distance of the University of MN
• agree not to use any recreational drugs while in the study ( for example, hallucinogens, ketamine, and marijuana)
• current or past history of a mental health issue
• currently taking any prescription medications on a daily basis, except birth control pills
• pregnant or breast feeding
• can't have a MRI
Composur, A Patient-centric, Phase IV, Open-label, Prospective, Real World US Study to Evaluate Vibegron on Patient Treatment Satisfaction, Quality of Life, and Healthcare Resource Utilization in Patients with Overactive Bladder
This study will evaluate treatment satisfaction, discontinuation, reasons for discontinuation, quality of life, healthcare resource utilization, and safety with vibegron for the treatment of OAB in the context of real-world clinical practice.
• diagnosis of overactive bladder (OAB) with or without urgency urinary incontinence
• symptoms of OAB for at least 3 months
• specific previous treatments for OAB (study staff will review)
• neurologic conditions associated with OAB symptoms, e.g., multiple sclerosis
• women who are pregnant or breast feeding or planning to become pregnant
PEPN2011 - A Phase 1/2 Study of Tegavivint (IND#156033, NSC#826393) in Children, Adolescents, and Young Adults with Recurrent or Refractory Solid Tumors, Including Lymphomas and Desmoid Tumors
This phase I/II trial evaluates the highest safe dose, side effects, and possible benefits of tegavivint in treating children, adolescents, and young adults with recurrent or refractory solid tumors, including lymphomas and desmoid tumors.
• 12 months to 30 years old
• patients with recurrent or refractory solid tumors including non-Hodgkin lymphoma and desmoid tumors are eligible
• patients must have fully recovered from the acute toxic effects of all prior anti-cancer therapy
• see link to clinicaltrials.gov for complete Inclusion and Exclusion criteria
• pregnant or breast-feeding women
• patients who are currently receiving other anti-cancer agents
• patients who are receiving cyclosporine, tacrolimus or other agents to prevent graft-versus-host disease post bone marrow transplant
• patients with primary brain tumors
• patients who have received a solid organ transplant
Edwards PASCAL TrAnScatheter Valve RePair System Pivotal Clinical Trial (CLASP II TR): A prospective, multicenter, randomized, controlled pivotal trial to evaluate the safety and effectiveness of transcatheter tricuspid valve repair with the Edwards PASCAL Transcatheter Valve Repair System and optimal medical therapy (OMT) compared to OMT alone in patients with tricuspid regurgitation (CLASP II TR)
The goal of this trial is to evaluate the safety and effectiveness of the PASCAL System with optimal medical therapy (OMT) compared to OMT alone in participants with symptomatic severe tricuspid regurgitation. We are studying this in patients who may not be ideal candidates for tricuspid valve surgery (performed via open-heart surgery) and may be eligible for transcatheter tricuspid valve repair (minimally invasive procedure that repairs the valve).
• at least 18 years old
• symptoms of severe tricuspid valve regurgitation in spite of medical treatment
• untreated coronary artery disease, unstable angina, evidence of acute coronary syndrome, recent myocardial infarction
• women who are pregnant, breastfeeding, or planning pregnancy within the next 12 months
• other significant medical diagnosis (study team 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
EPI-MINN: Targeting Cognition and Motivation in Coordinated Specialty Care for Early Psychosis: A National Comparison Study
This is a study enrolling patients receiving care for early psychosis across the United States. Participants will be randomly assigned to one of two groups. The first group will use two mobile apps, computerized brain training and a motivational smart phone app, for a period of 12 weeks. The other group will participate in their regular clinical care. There will be 4 study timepoints: intake, post-training, 6-month follow up, and 12-month follow up. There is also an optional interview about experiences of loneliness.
• aged 15-40 inclusive
• enrolled in an early psychosis coordinated specialty care clinic (PI will determine this)
• in good physical health & stable psychiatric status
• fluent in spoken and written English
• have access to a smart phone (or other mobile device) and computer or tablet
• participated in significant cognitive training programs within the last three years
• neurological disorder that may interfere with participation
• substance abuse disorder that would interfere with participation
• risk of suicidal behavior
SpHincterotomy for Acute Recurrent Pancreatitis (SHARP) Trial (SHARP)
We are studying the effectiveness of a new procedure to treat people who have episodes of acute pancreatitis with pancreas divisum. Of the participants, half will receive the new procedure called endoscopic retrograde cholangiopancreatography (ERCP) with minor papilla endoscopic spincterotomy (miES) the other half with receive only ERCP. We will monitor outcomes for at least eighteen months.
• at least 18 years old
• two or more episodes of acute pancreatitis, with one occurring in the last 24 months
• there is no certain explanation for recurrent acute pancreatitis
• prior minor papilla therapy (endoscopic or surgical)
• other causes of pancreatitis (study staff will review)
• regular use of opioid medication for abdominal pain for the past three months
RANDOMIZED NON-INFERIORITY TRIAL COMPARING OVERALL SURVIVAL OF PATIENTS MONITORED WITH SERUM TUMOR MARKER DIRECTED DISEASE MONITORING (STMDDM) VERSUS USUAL CARE IN PATIENTS WITH METASTATIC HORMONE RECEPTOR POSITIVE HER-2 NEGATIVE BREAST CANCER
This study is looking at how well serum tumor markers work to monitor people who have hormone receptor positive Her2 negative breast cancer that has spread to other places in the body. We want to see if using the markers (from a blood sample) is as good as using scans to monitor disease.
• diagnosis of hormone receptor positive (estrogen receptor positive [ER+] and/or progesterone receptor positive [PR+]), HER-2 negative, metastatic (M1) breast cancer
• receiving or plan to receive first-line systemic treatment for metastatic disease
• no other prior malignancy is allowed except for adequately treated basal (or squamous cell) skin cancer, in situ cervical cancer or other cancer for which the patient has been disease free for five years
• known cirrhosis, untreated B12 deficiency, thalassemia, or sickle cell anemia
• known brain leptomeningeal metastases
• must not be pregnant
EA5163/S1709 INSIGNA: A Randomized, Phase III Study of Firstline Immunotherapy alone or in Combination with Chemotherapy in Induction/Maintenance or Postprogression in Advanced Nonsquamous Non Small Cell Lung Cancer (NSCLC) with Immunobiomarker SIGNature driven Analysis
We are studying the use of pembrolizumab to treat people who have stage IV non-squamous, non-small cell lung cancer. Pembrolizumab may help the body’s own immune system attack cancer so tumor cells cannot grow and spread. We are looking at when it is most effective to give the pembrolizumab and when to combine it with other anticancer drugs, pemetrexed and carboplatin.
• confirmed stage IV non-squamous non-small cell lung cancer (NSCLC)
• PD-L1 expression Tumor Proportion Score (TPS) >= 1% in tumor cells -
• Prior systemic chemotherapy or immunotherapy for advanced metastatic NSCLC
• EGFR mutations (except exon 20 insertion), BRAF mutations (V600) or ALK or ROS1 translocations
• significant gastrointestinal disorders with diarrhea as a major symptom
• history of auto-immune condition (including Guillain-Barre Syndrome or Multiple Sclerosis) requiring ongoing or intermittent systemic treatment in the past 2 years
• pregnant or breast-feeding
A Randomized Phase II Study Comparing Single-Agent Olaparib, Single Agent Cediranib, and the Combination of Cediranib/Olaparib in Women with Recurrent, Persistent or Metastatic Endometrial Cancer
This study uses different drug combinations to treat women who have endometrial cancer that has come back or has not responded to treatment. The drugs have different ways of stopping the growth of tumor cells and we are looking to see if different combinations are more effective.
• recurrent or persistent endometrial carcinoma, which is refractory to curative therapy or established treatments
• following histologic epithelial cell types are eligible: endometrioid adenocarcinoma, serous adenocarcinoma, undifferentiated carcinoma, mixed epithelial carcinoma, adenocarcinoma not otherwise specified (N.O.S.); NOTE: clear cell histology is excluded
• must have had one prior chemotherapeutic regimen for management of endometrial carcinoma
• Body weight > 30 kg
• able to swallow and retain oral medications and without gastrointestinal illnesses that would preclude absorption
• Prior enrollment into a clinical trial including cediranib or olaparib; Note: prior bevacizumab is not an exclusion criterion
• Pregnant women are excluded
A Randomized Phase III Trial of Adjuvant Therapy Comparing Doxorubicin Plus Cyclophosphamide Followed by Weekly Paclitaxel with or without Carboplatin for Node-Positive or High-Risk Node-Negative Triple-Negative Invasive Breast Cancer
We are studying the addition of a drug to the treatment for people who have triple-negative breast cancer. Drugs used in chemotherapy work in different ways to stop the growth of tumor cells. Some people will receive the current treatment and others will have the current treatment with carboplatin added. The results of the two treatments will be compared.
• breast tumor must have been determined to be estrogen receptor (ER)-and progesterone receptor (PgR)-negative
• tumor must have been determined to be human epidermal growth factor receptor 2 (HER2)-negative
• surgery (mastectomy (total, skin-sparing, or nipple-sparing) or lumpectomy) completed no more than 60 days from enrollment
• T4 tumors including inflammatory breast cancer
• clinical or radiologic evidence of metastatic disease
• previous history of invasive breast cancer or DCIS in the same breast
• Chemotherapy administered for the currently diagnosed breast cancer prior to randomization
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.
• 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
• 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
COG ACNS1833 - A Phase 3 Randomized Non-Inferiority Study of Carboplatin and Vincristine versus Selumetinib (NSC# 748727, IND# 77782) in Newly Diagnosed or Previously Untreated Low-Grade Glioma (LGG) not associated with BRAFV600E Mutations or Systemic Neurofibromatosis Type 1 (NF1)
The overall goal of this phase 3 non-inferiority study is to assess if selumetinib works as well as the standard treatment using carboplatin and vincristine (called CV) for subjects with low-grade glioma (LGG).
• 2 to 21 years old
• all tumors considered low-grade glioma or low-grade astrocytoma
• patients with metastatic disease or multiple independent primary LGG are eligible
• patients must have the ability to swallow whole capsules
• see link to clinicaltrials.gov for complete inclusion and exclusion criteria
• must not have received any prior tumor-directed therapy including chemotherapy, radiation therapy, immunotherapy, or bone marrow transplant. Prior surgical intervention is permitted
Brain Connectivity Patterns in Chronic Temporomandibular Joint Disorders
We are studying brain mechanisms related to chronic temporomandibular disorder (TMD) pain. We are looking at brain structural and functional characteristics that can potentially explain why some people experience persistent pain in their jaws for months or years. We will compare this to information we get from people who do not experience TMD pain. We expect that this new knowledge will improve our understanding of this chronic pain condition and help us develop better treatments.
• Female participants only (biological sex)
• Age between 18-65 years
• Pain-free participants OR
• Chronic jaw pain ( > 3 months)
• Certain medical conditions (examples: heart disease, diabetes, autism, trigeminal neuralgia)
• Any MRI contraindications (examples: metal implants, claustrophobia)
• Being left-handed only
Assessments of sound perception and brain activation in response to paired sound and electrical stimulation of surface ear regions
We are investigating how paired non-invasive electrical stimulation of surface body regions and sound changes sound perception and tinnitus. Body stimulation regions include: external ear/behind the ear, shoulder, neck, forearm, hand, and upper arm. We aim to better understand the optimal conditions of this paired stimulation, which opens opportunities for applying this method to improving hearing loss or tinnitus. We are studying three groups of people: those with normal hearing, those with mild to moderate hearing loss, and those with tinnitus.
• normal hearing or hearing loss with or without tinnitus
• not users of Cochlear Implant or hearing aids
Targeting Family Meal Quality and Quantity to Reduce Childhood Obesity Using Ecological Momentary Intervention (EMI) and Video Feedback
The proposed study is an individual three-arm randomized controlled tiled aimed at utilizing state-of-the-art intervention methods to examine whether increasing the quality and the quantity of family meals reduces childhood obesity.
• Child 5-10 years old
• Have a sibling who lives in the home with the child
• Live in the Metro area
• Speaks English or Spanish
Plasticity of motor systems in early stage Parkinson's disease
The purpose of this project is to provide new knowledge of the relationship between structural and functional changes in cortico-basal ganglia pathways and the severity of motor and non-motor deficits in humans with PD.
• Diagnosis of Parkinson's disease
• Not taking medication to treat Parkinson's
• Age: 21-75 years
• Able to walk independently Inclusion Criteria For Control Subject Group: Age and sex matched to participants with PD and able to walk independently
• Dementia diagnosis
• History of musculoskeletal disorders
• History of bipolar disorder, post-traumatic stress disorder or major depressive disorder
• Other significant neurological disorders that may affect participation or performance in the study
• Implanted DBS or other neurosurgeries to treat PD
• Pregnant women
• History of seizures, epilepsy, stroke, multiple sclerosis, or traumatic brain injury
• Intracranial metallic or magnetic devices (e.g. cochlear implant, deep brain stimulator)
• Pacemaker or any implanted device
• History of surgery on blood vessels, brain, or heart
• Unexplained, recurring headaches or concussion within the last six months
• Severe hearing impairment Exclusion Criteria for Control subject Group: same as exclusion criteria of PD group
Measurement of Glucose Homeostasis in Human Brain by NMR: Effect of Recurrent Hypoglycemia on Type 1 Diabetes (Aim 2)
Individuals with type 1 diabetes often develop an impaired awareness of hypoglycemia (IAH), meaning they are not fully aware of having low blood glucose levels. This research study is looking to determine what happens in the brain after repeat episodes of hypoglycemia.
• 18 to 65 years old
• diagnosis of Type 1 diabetes
• diabetes duration 2 - 30 years
• Hemoglobin A1C less than 8.5%
• unaware of hypoglycemia when it is occurring
• pregnant or plan to become pregnant during the study
• uncontrolled hypertension (blood pressure greater than 145/95 mmHg)
• inability to undergo MRI scanning, including but not limited to unable to remain still in an MRI scanner for more than 30 minutes, claustrophobia, presence of paramagnetic substances or pacemakers in body, weight over 300 pounds
• other medical or mental health issues (study staff will review)
MultiStem Administration for Stroke Treatment and Enhanced Recovery Study (MASTERS-2)
This study is evaluating the efficacy of MultiStem (drug) on functional outcome in participants with ischemic stroke.
• clinical diagnosis of ischemic stroke involving cerebral cortex
• moderate to moderately severe stroke with a persistent neurologic deficit
• stroke involving other areas of the brain
• stroke or head injury within the past 6 months
Observational Study Assessing for Effect of CREON on Symptoms of Exocrine Pancreatic Insufficiency (EPI) in Patients with EPI due to Chronic Pancreatitis (CP) (CisCP)
CP is a progressive fibro-inflammatory disease where EPI develops due to destruction of pancreatic parenchyma or pancreatic duct distortion. EPI results in maldigestion, leading to fat-soluble vitamin deficiencies, weight loss, malnutrition, and impaired quality of life (Qol). Signs and symptoms of EPI include abdominal bloating and cramping, diarrhea, foul-smelling, greasy stools (steatorrhea), and unintentional weight loss. Pancreatic enzyme replacement therapy (PERT) is the mainstay of treatment of EPI. Treatment is aimed at reduction of maldigestion-related symptoms, and prevention of malnutrition and its related morbidity and mortality. CREON® is a PERT that has been FDA approved since 2009 for the treatment of EPI due to cystic fibrosis, CP, pancreatectomy, or other conditions
• at least 18 years old
• history of chronic pancreatitis (CP).
• diagnosis of Exocrine Pancreatic Insufficiency (EPI)
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
Post-contracture release radiation for Dupuytren's disease
The purpose of this study is to critically assess the current treatment that patients are undergoing by reviewing routine data collected and adding one additional outcome questionnaire solely for research purposes
• at least 18 years old
• diagnoses of Dupuytren's disease
• English-speaking
• people who have Dupuytren's disease and are not currently seeking treatment
Maternal probiotic supplementation for improved neurodevelopmental outcomes in infants of diabetic mothers (IDMs)
The purpose of this study is to see whether providing pregnant women with probiotics during their pregnancy is associated with infant gut microbiome variation and improved neurodevelopmental outcomes. We expect that you and your child will be in this research study for approximately 8 months from the time you sign the consent from to the completion of your 6-month visit with your infant.
• pregnant women in their second or third trimester with a diagnosis of gestational diabetes
• screening for gestational diabetes involves a 2-step (screening test followed by a diagnostic test) with screening done between 24 and 28 weeks of gestation in a non-fasting state. If the screening threshold is met or exceeded, patients receive a oral glucose tolerance test (OGTT)
• BMI 18.5-45 kg/m2 at first prenatal visit
• age 21-45 at time of delivery
• pregnant women who report during enrollment procedures that they have social support for and intention to exclusively breastfeed for at least 3 months (breastfeeding intentions are known to be correlated with actual behavior)
• single pregnancy
• alcohol consumption >1 drink per week during pregnancy/lactation
• tobacco consumption during pregnancy or lactation
• inability to speak and understand English
• known congenital metabolic, endocrine disease (other than GDM), or congenital illness affecting infant feeding
• history of type I Diabetes
• mothers currently taking over the counter probiotic preparation
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.
• Age 18 years or older
• Undergoing abdominal surgical procedure with general anesthesia
• Pregnancy or nursing
• Physician may exclude
Choline Supplementation as a Neurodevelopmental Intervention in Fetal Alcohol Spectrum Disorders Study (CHOLINE4)
The main purpose of this study is to see whether choline can help cognitive development (thinking / memory) in children with Fetal Alcohol Spectrum Disorders (FASD). The study will compare choline with a placebo to see if taking choline is better than taking a placebo. The placebo in this study looks and tastes like choline but has no choline in it. Choline is a nutrient found in many foods and is grouped within the vitamin B complex.
• ages 2.5 years to 5 years old (<6 years of age)
• prenatal alcohol exposure
• history of a neurological condition (epilepsy, traumatic brain injury)
• history of a medical condition known to affect brain function
• other neurodevelopmental disorder (autism, Down syndrome)
• history of very low birthweight (<1500 grams)
RARE-OB-16: Rare CFTR Mutation Cell Collection Protocol (RARE) (RARE)
We are doing the RARE study to learn more about Cystic Fibrosis (CF). CF is caused by mutations in a gene that produces a protein called the cystic fibrosis transmembrane conductance regulator (CFTR). In people with CF, the CFTR does not function correctly. Medications are being developed to help the CFTR function better, but those medications mostly benefit people with common CFTR mutations. There are more than 1,900 mutations of the CF gene. Some of these mutations are rare and found only in a few people. The goal of this research study is to collect specimens (blood, nasal cells, rectal cells) from people with rare CFTR mutations. Another purpose of this study is to create induced pluripotent stem cells or iPS cells. “Pluripotent” stem cells are cells that can be changed into almost any cell type of the body (such as lung or intestine). They can be kept alive and stored indefinitely. There are different kinds of pluripotent stem cells. Inducted pluripotent stem cells can be created from many different kinds of specimens (such as blood, nasal cells, rectal cells). This is different from embryonic stem cells, which can only be derived from embryos. The specimens collected during this study and iPS cells created from them will be stored for use in future research to learn more about CF and study the effect of new medications. This could identify new medications that may help people with rare CFTR mutations.
• at least 12 years old
• documented diagnosis of Cystic Fibrosis (CF)
• willing to travel (if needed) to a regional study site for cell collection
• presence of a medical condition, abnormality, or laboratory value that would place the participant at risk (study staff will review)