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Condition of Interest |
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Alzheimer's Disease Neuroimaging Initiative 4
Mild Cognitive Impairment
Alzheimer Disease
Dementia
Since its launch in 2004, the overarching aim of the Alzheimer's Disease Neuroimaging
Initiative (ADNI) Study has been to validate biomarkers for Alzheimer's disease (AD)
clinical trials. ADNI4 continues the previously funded ADNI1, ADNI-GO, ADNI2, and ADNI3
studies that have combined public/privat1 expand
Since its launch in 2004, the overarching aim of the Alzheimer's Disease Neuroimaging Initiative (ADNI) Study has been to validate biomarkers for Alzheimer's disease (AD) clinical trials. ADNI4 continues the previously funded ADNI1, ADNI-GO, ADNI2, and ADNI3 studies that have combined public/private collaborations between academia and industry to determine the relationships between the clinical, cognitive, imaging, genetic and biochemical biomarker characteristics of the entire spectrum of AD. Type: Observational Start Date: Jun 2023 |
Assessment of the Ocular Microbiome in Health and Disease
Microbial Colonization
Eye Diseases
Ophthalmopathy
The objective of this application is to illustrate the core constituents of the ocular
surface microbiome, describe factors that promote colonization, and assess the ocular
microbiome's role in the health of the anterior segment. We will conduct a prospective,
observational cohort study, including1 expand
The objective of this application is to illustrate the core constituents of the ocular surface microbiome, describe factors that promote colonization, and assess the ocular microbiome's role in the health of the anterior segment. We will conduct a prospective, observational cohort study, including a longitudinal analysis of the ocular microbiome in adults. Type: Observational Start Date: Sep 2023 |
Stereotactic Radiosurgery for Essential Tremor and Parkinsonian Tremor
Tremor
Essential Tremor
Parkinson Disease
Radiosurgery
Quality of Life
The purpose of this study is to determine the changes in quality of life and degree of
tremor for patients with essential tremor or Parkinsonian tremor who are treated by
stereotactic radiosurgery (SRS). This is a questionnaire-based study. Please see Detailed
Description below for more information. expand
The purpose of this study is to determine the changes in quality of life and degree of tremor for patients with essential tremor or Parkinsonian tremor who are treated by stereotactic radiosurgery (SRS). This is a questionnaire-based study. Please see Detailed Description below for more information. Type: Observational Start Date: Feb 2013 |
Cognitive Enhancement in Depression (The COG-D Study)
Aging
Depression
Cognitive Symptom
This study will investigate whether transcranial direct current stimulation (tDCS)
enhances the effects of computerized cognitive training in older adults with recurrent
depression (2 or more lifetime episodes; either current or within past 3 years). expand
This study will investigate whether transcranial direct current stimulation (tDCS) enhances the effects of computerized cognitive training in older adults with recurrent depression (2 or more lifetime episodes; either current or within past 3 years). Type: Interventional Start Date: Feb 2023 |
2-HOBA Phase 2 Clinical Trial in Rheumatoid Arthritis
Rheumatoid Arthritis
This is a phase 2 study to determine 2-HOBA's tolerability, safety, and effect on
isoLG-adducts in patients with rheumatoid arthritis (RA) patients. Up to 32 subjects will
be randomized to 750mg 2-HOBA or matching placebo three times a day for 4 weeks.
As primary outcome measures investigators wil1 expand
This is a phase 2 study to determine 2-HOBA's tolerability, safety, and effect on isoLG-adducts in patients with rheumatoid arthritis (RA) patients. Up to 32 subjects will be randomized to 750mg 2-HOBA or matching placebo three times a day for 4 weeks. As primary outcome measures investigators will compare tolerability and adverse events and changes in isoLG adducts in active and placebo arms. Among prespecified exploratory outcomes investigators will compare changes in markers of inflammation, DAS28 score, and 24-hour blood pressure in active and placebo arms. This pilot study will inform the feasibility and design of future studies to examine the efficacy of 2-HOBA in RA patients. Type: Interventional Start Date: Aug 2022 |
Imaging Sodium and Lymphatics in Lymphedema
Lymphedema of Leg
Lymphedema, Secondary
Lymphedema Related Fibrosis
Recent evidence supports lymphatic regulation of tissue sodium handling, however
fundamental gaps persist in knowledge regarding the role of lymphatics in human diseases
of sodium dysregulation. The goal of this work is to apply novel, noninvasive imaging
tools to measure relationships between lymp1 expand
Recent evidence supports lymphatic regulation of tissue sodium handling, however fundamental gaps persist in knowledge regarding the role of lymphatics in human diseases of sodium dysregulation. The goal of this work is to apply novel, noninvasive imaging tools to measure relationships between lymphatic function and tissue sodium in patients with well-characterized lymphedema. Findings are intended to inform mechanisms of lymphatic clearance of tissue sodium, and provide novel imaging biomarkers of lymphedema progression and treatment response. Type: Observational Start Date: Oct 2021 |
Memantine for the Treatment of Cognitive Impairment in Systemic Lupus Erythematosus
Lupus Erythematosus, Systemic
A phenome-wide association study (PheWAS) identified an association between a variant in
the human gene for the N2A subunit of the N-methyl-D-aspartate (NMDA) receptor, GRIN2A,
and Systemic Lupus Erythematosus (SLE). A single nucleotide polymorphism (SNP) in this
gene encodes for increased NMDA rec1 expand
A phenome-wide association study (PheWAS) identified an association between a variant in the human gene for the N2A subunit of the N-methyl-D-aspartate (NMDA) receptor, GRIN2A, and Systemic Lupus Erythematosus (SLE). A single nucleotide polymorphism (SNP) in this gene encodes for increased NMDA receptor activity. Based on the potential function of the associated SNP and published literature, alterations in SNP function signaling may underlie a cluster of symptoms. The objective of this study is to evaluate the safety, tolerability and efficacy of memantine, an NMDA receptor antagonist, in a precise patient subset with SLE. Participants will complete a full 14-week clinical trial, receiving either memantine or a placebo. Participants' blood will be drawn to test for various antibodies as well as organ function. Patients' urine will also be collected to assess organ function and pregnancy for females at a number of specific time points. The overall goal is to develop a safe and inexpensive therapeutic approach to reduce debilitating cognitive symptoms in a precisely selected SLE sub-population. Type: Interventional Start Date: Aug 2018 |
Effect of PDE5 Inhibition on Adipose Metabolism in Humans
Obesity
This is a randomized, double-blinded, placebo-controlled study of the effects of PDE5
inhibition with tadalafil on adipose tissue in obese individuals. Adipose metabolism will
be measured using magnetic resonance imaging (MRI) scans and by aspirating a small amount
of adipose to measure gene expres1 expand
This is a randomized, double-blinded, placebo-controlled study of the effects of PDE5 inhibition with tadalafil on adipose tissue in obese individuals. Adipose metabolism will be measured using magnetic resonance imaging (MRI) scans and by aspirating a small amount of adipose to measure gene expression. Type: Interventional Start Date: Mar 2021 |
EMT en Español for Spanish-speaking Toddlers With Language Delays
Language Development Disorders
The goal of the study is to conduct an initial efficacy study of a promising therapist
and caregiver-implemented communication intervention to improve language and school
readiness skills in low-income Spanish-speaking children with receptive and expressive
language delays (ages 30 to 36 months). T1 expand
The goal of the study is to conduct an initial efficacy study of a promising therapist and caregiver-implemented communication intervention to improve language and school readiness skills in low-income Spanish-speaking children with receptive and expressive language delays (ages 30 to 36 months). The proposed randomized trial compares the effects of a caregiver plus therapist implemented EMT en Español intervention to a community based "business as usual" control group at four time points (pre- intervention, post-intervention, 6 month follow-up, 12 month follow-up) in a sample of 84 low-income, Spanish-speaking families and their toddlers with receptive and expressive language delays. Type: Interventional Start Date: Dec 2019 |
Trial-Ready Cohort-Down Syndrome (TRC-DS)
Down Syndrome
Alzheimer Disease
Dementia
The purpose of the Trial-Ready Cohort - Down Syndrome (TRC-DS) is to enroll 120 healthy
adults with Down syndrome (DS), between the ages of 25-55, into a trial ready cohort
(TRC), and up to 450 participants in total including co-enrolled in the Alzheimer
Biomarkers Consortium - Down Syndrome (ABC-D1 expand
The purpose of the Trial-Ready Cohort - Down Syndrome (TRC-DS) is to enroll 120 healthy adults with Down syndrome (DS), between the ages of 25-55, into a trial ready cohort (TRC), and up to 450 participants in total including co-enrolled in the Alzheimer Biomarkers Consortium - Down Syndrome (ABC-DS) study. Participants enrolled in the TRC-DS will undergo longitudinal cognitive and clinical assessment, genetic and biomarker testing, as well as imaging and biospecimen collection. Using these outcome measures, researchers will analyze the relationships between cognitive measures and biomarkers of Alzheimer's disease (AD) to identify endpoints for AD clinical trials in DS that best reflect disease progression. To learn more about the study and participating sites, visit our study website at: https://www.trcds.org/. TRC-DS is collaborating with the Alzheimer's Disease Biomarker Consortium-Down Syndrome (ABC-DS) to allow study participants to be concurrently enrolled in both ABC-DS and TRC-DS, referred to as "co-enrollment". ABC-DS is a longitudinal, observational research study that is overseen at University of Pittsburgh Coordinating Center. ABC-DS participants who express interest in potentially joining a clinical trial in the future and who meet TRC-DS eligibility criteria, may choose to co-enroll in TRC-DS at an ABC-DS Site. Co-enrolled participants will adhere to the ABC-DS protocol and schedule of activities, but agree to share their data with the TRC-DS team and to receive invitations for future participation in clinical trials. Fore more information on ABC-DS please visit https://www.nia.nih.gov/research/abc-ds or http://abcds.pitt.edu/. Type: Observational Start Date: Jun 2021 |
Interventions for Reading Disabilities in NF1
Neurofibromatosis Type 1
Learning Disability
Reading Disability
NF1
Neurofibromatosis Type 1 (NF1) is a common genetic disorder that is associated with a
four times greater risk of learning disabilities, including reading disabilities, and a
deficiency of neurofibromin - a protein important in a signaling pathway that regulates
learning and memory. Our previous wor1 expand
Neurofibromatosis Type 1 (NF1) is a common genetic disorder that is associated with a four times greater risk of learning disabilities, including reading disabilities, and a deficiency of neurofibromin - a protein important in a signaling pathway that regulates learning and memory. Our previous work (NS49096) demonstrated that school-age children with NF+RD can respond to standard phonologically-based reading tutoring originally developed to treat reading disability in the general population. Combining our work with that by other researchers suggesting that a medication (Lovastatin) may counteract the effects of the deficient neurofibromin, and possibly ameliorate learning disabilities in NF1, the investigator propose to examine the synergistic effects of medication plus reading tutoring. Type: Interventional Start Date: Nov 2016 |
Levocarnitine for Dry Eye in Sjogren's Syndrome
Sjogren's Syndrome
Keratoconjunctivitis Sicca
This study evaluates the effectiveness of levocarnitine in the treatment of dry eye in
adults with Sjogren's syndrome. This will be a crossover study design with all
participants receiving both levocarnitine and placebo. expand
This study evaluates the effectiveness of levocarnitine in the treatment of dry eye in adults with Sjogren's syndrome. This will be a crossover study design with all participants receiving both levocarnitine and placebo. Type: Interventional Start Date: Nov 2021 |
MOdification Of THe Early-Life Respiratory Microbiome Through Vaginal SEEDing
Cesarean Section
Vaginal Seeding
Nose
Microbiome
This is a single-center, parallel-arm, blind, sham-controlled, feasibility randomized
controlled trial (RCT) to be conducted in healthy cesarean-born infants. Eligible infants
will be randomized 1:1 to have their nose swabbed with either maternal vaginal secretions
or a sterile swab (intervention v1 expand
This is a single-center, parallel-arm, blind, sham-controlled, feasibility randomized controlled trial (RCT) to be conducted in healthy cesarean-born infants. Eligible infants will be randomized 1:1 to have their nose swabbed with either maternal vaginal secretions or a sterile swab (intervention vs. control group, respectively) following birth by cesarean section (C-section). The main hypothesis is that conducting an RCT assessing the utility of vaginal seeding in modifying the early-life upper respiratory tract (URT) microbiome of infants born by C-section is feasible and that the intervention is safe. Type: Interventional Start Date: Nov 2022 |
A Trial to Learn if Dupilumab is Safe for and Helps Adult and Adolescent Participants With Eosinoph1
Eosinophilic Gastritis
Eosinophilic Duodenitis
Eosinophilic Gastrointestinal Disease
The study is researching an experimental drug called dupilumab. The study is focused on
participants with active eosinophilic gastritis (EoG) with or without eosinophilic
duodenitis (EoD). Participants with EoD only are not eligible for enrollment. EoG and EoD
are uncommon, persistent, allergic/imm1 expand
The study is researching an experimental drug called dupilumab. The study is focused on participants with active eosinophilic gastritis (EoG) with or without eosinophilic duodenitis (EoD). Participants with EoD only are not eligible for enrollment. EoG and EoD are uncommon, persistent, allergic/immune diseases in which eosinophils (a type of white blood cell) gather in large numbers in the stomach and small intestine and cause inflammation and damage. The aim of the study is to evaluate the effect of dupilumab on relieving EoG (with or without EoD) symptoms and reducing inflammation in the stomach and, if applicable, small intestine in adults and adolescents aged 12 years and older, compared to placebo. The study is looking at several other research questions, including: - What side effects may happen from taking the study drug - How much study drug is in your blood at different times - Whether the body makes antibodies against the study drug (which could make the drug less effective or could lead to side effects) Type: Interventional Start Date: May 2023 |
PROGRESS: Management of Moderate Aortic Stenosis by Clinical Surveillance or TAVR
Aortic Stenosis, Calcific
Aortic Valve Stenosis
This study objective is to establish the safety and effectiveness of the Edwards SAPIEN 3
/ SAPIEN 3 Ultra / SAPIEN 3 Ultra RESILIA Transcatheter Heart Valve systems in subjects
with moderate, calcific aortic stenosis.
Following completion of enrollment, subjects will be eligible for enrollment in1 expand
This study objective is to establish the safety and effectiveness of the Edwards SAPIEN 3 / SAPIEN 3 Ultra / SAPIEN 3 Ultra RESILIA Transcatheter Heart Valve systems in subjects with moderate, calcific aortic stenosis. Following completion of enrollment, subjects will be eligible for enrollment in the continued access phase of the trial. Type: Interventional Start Date: Oct 2021 |
Stress and Opioid Misuse Risk: The Role of Endogenous Opioid and Endocannabinoid Mechanisms
Opioid Use Disorder
Back Pain
Stress
The purpose of this study is to see how stress influences the effects of opioid pain
medications often used to help relieve back pain. The study will help to learn more about
how high stress levels could increase risk for pain medication misuse. expand
The purpose of this study is to see how stress influences the effects of opioid pain medications often used to help relieve back pain. The study will help to learn more about how high stress levels could increase risk for pain medication misuse. Type: Interventional Start Date: Mar 2022 |
CBT Enhanced With Social Cognitive Training vs. CBT Only With Depressed Youth
Depression
Depression in youth is a serious public health concern for which more personalized
treatments are needed. This randomized controlled trial will test the effect of an
intervention aimed at enhancing social cognitive capacities (e.g., ability to take
another's perspective), thereby making treatment o1 expand
Depression in youth is a serious public health concern for which more personalized treatments are needed. This randomized controlled trial will test the effect of an intervention aimed at enhancing social cognitive capacities (e.g., ability to take another's perspective), thereby making treatment of depression in youth more efficient and effective. Participants in the R33 (N=82) will be youth between ages 13- through 17-years-old currently experiencing depression. Youth will be randomized to either an enhanced CBT intervention that teaches social cognitive skills, particularly social perspective taking and theory of mind (CBTSCT) as compared to CBT only. The primary target is improvement in both social cognitive skills and depressive symptoms at post-treatment and at a 6-month follow-up. Type: Interventional Start Date: Oct 2022 |
Cardiovascular Autonomic and Immune Mechanism of Post COVID-19 Tachycardia Syndrome
Post-acute COVID-19 Syndrome
Postural Tachycardia Syndrome (POTS)
Long COVID
SARS CoV 2 Infection
The term post-acute COVID-19 syndrome or Long COVID is a disabling syndrome that persists
beyond the 3-month convalescence period after COVID-19 infections.
This syndrome affects mostly women (~80%), present with chronic tachycardia and
Orthostatic intolerance symptoms without any identifiable cau1 expand
The term post-acute COVID-19 syndrome or Long COVID is a disabling syndrome that persists beyond the 3-month convalescence period after COVID-19 infections. This syndrome affects mostly women (~80%), present with chronic tachycardia and Orthostatic intolerance symptoms without any identifiable cause. In addition, non-specific symptoms such as fatigue, headache, and "brain fog", commonly described in POTS patients are also present in this novel condition, recently named post-COVID-19 tachycardia syndrome, POTS variant. Reduced Vagal activity and unresolved inflammation is post-COVID-19 POTS is hypothesized as the cause of Long COVID Type: Interventional Start Date: Jun 2022 |
Splanchnic Venous Capacitance in Postural Tachycardia Syndrome
Postural Tachycardia Syndrome (POTS)
Postural tachycardia syndrome (POTS) affects ≈3 million young people, characterized by
chronic presyncopal symptoms characterized by dizziness, lightheadedness, and orthostatic
tachycardia that occur while standing. Across-sectional survey found that 25% of these
patients complains that meals rich1 expand
Postural tachycardia syndrome (POTS) affects ≈3 million young people, characterized by chronic presyncopal symptoms characterized by dizziness, lightheadedness, and orthostatic tachycardia that occur while standing. Across-sectional survey found that 25% of these patients complains that meals rich in carbohydrates are among the factors that further exacerbate POTS's symptoms and cause a myriad of gastrointestinal symptoms. The splanchnic circulation is the largest blood volume reservoir of the human body, storing ≈25% of the total blood volume and contributing to sudden, and large, fluctuations in the stroke volume (SV). The orthostatic changes in systemic hemodynamics are particularly magnified after meals, due to increased blood volume sequestration triggered by the release of gastrointestinal peptides with vasodilatory properties. The purpose of this study is to determine if the worsening orthostatic tachycardia and symptoms after glucose ingestion in POTS patients are due to a greater increase in splanchnic venous capacitance and excessive blood pooling on standing as compare to Healthy controls. The study will also determine if glucose-induced GIP secretion increases splanchnic venous capacitance, orthostatic tachycardia and worsening POTS postprandial symptoms. For this purpose subjects will be further randomized to either saline versus GIP(3-30)NH2 acute infusion, to measure the changes their splanchnic venous capacitance and superior mesenteric arterial flow before and after a 75-g oral glucose challenge during supine and 45-degree head-up tilt positions (orthostatic challenge) for up to 3 hours. Type: Interventional Start Date: Feb 2023 |
Glucagon-Like Peptide-1 Receptor Agonist in the Treatment of Adult, Obesity-related, Symptomatic As1
Asthma
This is a randomized placebo-controlled trial of semaglutide, an FDA-approved therapy for
the treatment of type 2 diabetes mellitus and obesity, in adults with symptomatic asthma
despite the use of inhaled steroids and with excess body weight. This study will test the
central hypothesis that semagl1 expand
This is a randomized placebo-controlled trial of semaglutide, an FDA-approved therapy for the treatment of type 2 diabetes mellitus and obesity, in adults with symptomatic asthma despite the use of inhaled steroids and with excess body weight. This study will test the central hypothesis that semaglutide will improve asthma control and reduce airway inflammation due to direct effects on the respiratory tract in adult asthma associated with obesity. Type: Interventional Start Date: Oct 2022 |
Dopaminergic Dysfunction in Late-Life Depression
Late Life Depression
Cognitive Decline
Depressive Disorder, Treatment-Resistant
Levodopa
Gait Impairment
Late-Life Depression (LLD), or depression in older adults, often presents with
motivational deficits, deficits in performance in cognitive domains including processing
speed and executive dysfunction, and mobility impairments. This triad of findings
implicate dopaminergic dysfunction as a core path1 expand
Late-Life Depression (LLD), or depression in older adults, often presents with motivational deficits, deficits in performance in cognitive domains including processing speed and executive dysfunction, and mobility impairments. This triad of findings implicate dopaminergic dysfunction as a core pathophysiologic feature in depression, and may contribute to cognitive decline and motor disability. Normal aging results in brain-wide dopamine declines, decreased D1/D2 receptor density, and loss of dopamine transporters. Although brain changes associated with depression and aging converge on dopamine circuits, the specific disturbances in LLD and how responsive the system is to modulation remain unclear. In this study, investigators are testing integrative model that aging, in concert with pro-inflammatory shifts, decreases dopamine signaling. These signally changes affects behaviors supported by these circuits, in the context of age-associated cortical atrophy and ischemic microvascular changes, resulting in variable LLD phenotypes. Investigators propose a primary pathway where dopaminergic dysfunction in depressed elders contributes to slowed processing speed and mobility impairments that increase the effort cost associated with voluntary behavior. The central hypothesis of this study is that late-life depression is characterized by dysfunction in the dopamine system and, by enhancing dopamine functioning in the brain. By improving cognitive and motor slowing, administration of carbidopa/levodopa (L-DOPA) will improve depressive symptoms. Type: Interventional Start Date: Feb 2021 |
Pragmatic Evaluation of Events And Benefits of Lipid-lowering in Older Adults
Cognitive Impairment, Mild
Dementia
Cardiovascular Diseases
PREVENTABLE is a multi-center, randomized, parallel group, placebo-controlled superiority
study. Participants will be randomized 1:1 to atorvastatin 40 mg or placebo. This large
study conducted in community-dwelling older adults without cardiovascular disease (CVD)
or dementia will demonstrate the1 expand
PREVENTABLE is a multi-center, randomized, parallel group, placebo-controlled superiority study. Participants will be randomized 1:1 to atorvastatin 40 mg or placebo. This large study conducted in community-dwelling older adults without cardiovascular disease (CVD) or dementia will demonstrate the benefit of statins for reducing the primary composite of death, dementia, and persistent disability and secondary composites including mild cognitive impairment (MCI) and cardiovascular events. Type: Interventional Start Date: Sep 2020 |
Pain Type and Interstitial Cystitis/Bladder Pain Syndrome Treatment
Chronic Interstitial Cystitis
Bladder Pain Syndrome
Painful Bladder Syndrome
Cystitis, Interstitial
Cystitis, Chronic Interstitial
Interstitial cystitis/bladder pain syndrome (IC/BPS) is a severe pain condition affecting
3-8 million people in the United States lacking treatments that work. Emotional suffering
is common in IC/BPS and known to make physical symptoms worse, and studies show patient
sub-groups respond differently1 expand
Interstitial cystitis/bladder pain syndrome (IC/BPS) is a severe pain condition affecting 3-8 million people in the United States lacking treatments that work. Emotional suffering is common in IC/BPS and known to make physical symptoms worse, and studies show patient sub-groups respond differently to treatment. Individuals with IC/BPS have distinct subgroups, or "phenotypes," largely characterized by the distribution of pain throughout the body. Supported by our preliminary evidence, the overall goal of this project is to assess how IC/BPS phenotype may affect response to two different therapies often given without regard to patient phenotype, pelvic floor physical therapy (PT) and cognitive-behavioral therapy (CBT) for IC/BPS. Type: Interventional Start Date: May 2024 |
VICE-MPRINT: Maternal and Pediatric Pharmacogenetics Survey
Pharmacogenomic Testing
The field of pharmacogenetics has progressed from the discovery of genetic variants that
cause variable function of drug metabolism enzymes to a cornerstone of clinical precision
medicine. However, there are limited data supporting drug-gene associations for children
and for women during and after1 expand
The field of pharmacogenetics has progressed from the discovery of genetic variants that cause variable function of drug metabolism enzymes to a cornerstone of clinical precision medicine. However, there are limited data supporting drug-gene associations for children and for women during and after pregnancy. The unique physiology of childhood and pregnancy demand validation of pharmacogenetic signals prior to clinical implementation. These knowledge gaps are compounded for individuals from minority populations, who have been underrepresented and thus underserved by genomic research and specifically pharmacogenetic studies. The primary objective of this project is to advance research and support clinical implementation in pharmacogenetics for children and pregnant women. This work will illuminate knowledge of, attitudes about, and priorities for pharmacogenetics, and will assess the impact of a brief educational video on knowledge and attitudes around pharmacogenetic testing. The investigators will assess the knowledge and attitudes regarding pharmacogenetic testing among diverse cohorts of children with chronic conditions and pregnant women, before and after receiving pharmacogenetic test results. Participants will be randomized to view an educational video about pharmacogenetic testing either at the time of receiving their pharmacogenetic test results, or at a later time. The investigators will perform surveys before and after pharmacogenomic testing and return of results, and before and after watching the educational video. Type: Interventional Start Date: Jun 2022 |
Enhancing Parasympathetic Activity to Improve Endothelial Dysfunction, Vascular Oxidative Stress in1
Endothelial Dysfunction
Specific Aim 1: To test the hypothesis that prolonged (3-month) treatment with
galantamine inhibits NADPH IsoLG-protein adducts formation and improves markers of
endothelial cell (EC) dysfunction in AAs.
Aim 1a: The investigators will determine if galantamine inhibits NADPH IsoLG-protein
adducts f1 expand
Specific Aim 1: To test the hypothesis that prolonged (3-month) treatment with galantamine inhibits NADPH IsoLG-protein adducts formation and improves markers of endothelial cell (EC) dysfunction in AAs. Aim 1a: The investigators will determine if galantamine inhibits NADPH IsoLG-protein adducts formation, superoxide production, and immune cell activation compared to placebo. For this purpose, the investigators will study peripheral blood mononuclear cell (PBMC), a critical source of systemic oxidative stress, collected from study participants. Aim 1b: The investigators will determine if galantamine reduces intracellular Iso-LGs, ICAM-1, and 3-nitrotyrosine, a marker of vascular oxidative stress, in ECs harvested from study participants. Specific Aim 2: To determine if prolonged (3-month) treatment with galantamine improves endothelial dysfunction as measured by vascular reactivity in AAs. The investigators will measure vascular reactivity in response to ischemia in two vascular beds: (a) in conduit arteries (brachial artery) using brachial artery diameter flow-mediated dilation (FMD), and (b) in the microvasculature (MBV) using contrast-enhanced ultrasonography in skeletal muscle. This proposal will study a novel mechanism that could alter the oxidative and immunogenic responses that contributes to endothelial dysfunction in AAs and will offer a potential pathway for the development of more effective therapies aimed at decreasing the progression of endothelial dysfunction to cardiovascular disease in this population. Type: Interventional Start Date: Dec 2021 |