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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... 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 |
Sympathetic Mechanisms in Obesity-Crossover Design
Obesity
Hypertension
We will study obese hypertensive subjects in a randomized, crossover study to determine if
two weeks sympathetic blockade improves endogenous glucose production. Subjects will be
studied on 3 different occasions after two weeks of receiving either placebo, amlodipine
(vasodilator... expand
We will study obese hypertensive subjects in a randomized, crossover study to determine if two weeks sympathetic blockade improves endogenous glucose production. Subjects will be studied on 3 different occasions after two weeks of receiving either placebo, amlodipine (vasodilator arm) or moxonidine (study arm). The order of the studies will be determined using computer-generated randomization. Patients will be blinded as to which treatment they are receiving on each day. An investigator blinded to the treatment assignment will perform the analysis of the data. Type: Interventional Start Date: May 2022 |
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 |
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... 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 |
Memory Improvement Through Nicotine Dosing (MIND) Study
Mild Cognitive Impairment
The purpose of the study is to see if daily transdermal nicotine is able to produce a
significant cognitive, clinical and functional improvement in participants with MCI. Neuronal
nicotinic receptors have long been known to play a critical role in memory function in
preclinical... expand
The purpose of the study is to see if daily transdermal nicotine is able to produce a significant cognitive, clinical and functional improvement in participants with MCI. Neuronal nicotinic receptors have long been known to play a critical role in memory function in preclinical studies, with nicotine improving attention, learning, and memory function. The study will enroll 380 participants for a 2 year period. Participants will be randomized (50:50) to either the transdermal nicotine, beginning at 7mg/day, and increasing to 21mg/day, or placebo skin patch. Type: Interventional Start Date: Jan 2017 |
Reducing Sedentary Time in Patients With Cardiovascular Disease
Cardiovascular Diseases
Heart Diseases
Sedentary Behavior
Physical Activity
The purpose of this study is to develop and test a 12-week sedentary behavior reduction
intervention ("Sit Less" program) for patients with cardiovascular disease. The program aims
to reduce and break sitting times among this population using an objective activity monitor... expand
The purpose of this study is to develop and test a 12-week sedentary behavior reduction intervention ("Sit Less" program) for patients with cardiovascular disease. The program aims to reduce and break sitting times among this population using an objective activity monitor and mHealth. The investigators will test the program to help cardiovascular disease patients break up sitting time, reduce daily sitting time, and move more. The investigators will also study whether the program leads to improvements in heart disease risk factors, and whether cardiovascular disease patients like the program and can follow it. Type: Interventional Start Date: Sep 2022 |
Whole Prediabetes: A Family-Centered Whole Foods Diet in Adults With Prediabetes and Their Offspring
PreDiabetes
This study will address the following aims:
Aim 1: Design a family-centered whole foods diet adapted from the 2020-2025 DGA framework for
8-12 families that include an index parent (25-59 years) with medically managed prediabetes
and their biological offspring (6-17 years).... expand
This study will address the following aims: Aim 1: Design a family-centered whole foods diet adapted from the 2020-2025 DGA framework for 8-12 families that include an index parent (25-59 years) with medically managed prediabetes and their biological offspring (6-17 years). Aim 2: Test the feasibility, acceptability, enrollment, retention, and completion rates of a 2-week family-centered whole foods-based diet for 8-12 families that include an index parent (25-59 years) with medically managed prediabetes and their biological offspring 6-17 years. Aim 3: Estimate and compare differences in baseline and 2-week body mass change (e.g., BMI, BMI percentiles and Z-scores, waist circumference) and diet quality for the index parent and their enrolled biological offspring. Type: Interventional Start Date: Oct 2022 |
Enhancing Parasympathetic Activity to Improve Endothelial Dysfunction, Vascular Oxidative Stress in African...
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... 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 |
Autonomic Determinants of POTS - Pilot 2
Postural Tachycardia Syndrome
Postural tachycardia syndrome (POTS) is a relatively common condition affecting mostly
otherwise healthy young women. These patients have high heart rate and disabling symptoms
during standing. Quality of life may be poor. The sympathetic nerves in the autonomic nervous
system... expand
Postural tachycardia syndrome (POTS) is a relatively common condition affecting mostly otherwise healthy young women. These patients have high heart rate and disabling symptoms during standing. Quality of life may be poor. The sympathetic nerves in the autonomic nervous system help to maintain normal blood pressures and heart rates during activities of daily life. The purpose of this study is to determine the importance of sympathetic activation as a cause of orthostatic symptoms. The investigators will assess the effects of a blood pressure medication (Moxonidine) on the symptoms during standing. Moxonidine lowers sympathetic activity. The investigators believe patients with high resting sympathetic activity might benefit from Moxonidine. It might reduce high heart rate and improve symptoms during standing. This study should help clinicians and the growing population of patients with POTS gain a better understanding of this disorder and find more personalized treatment. Type: Interventional Start Date: Aug 2021 |
Glucagon-Like Peptide-1 Receptor Agonist in the Treatment of Adult, Obesity-related, Symptomatic Asthma...
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... 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 |
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... 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... 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 |
Investigating Biological Markers, Targets, and Intervention for Mood Disorders
Major Depressive Disorder
Depression
Stress
This multi-modal methods study will investigate neurophysiological, endocrinological,
cognitive, psycho-social-emotional markers of disease, and targets for integrative health
treatments in mood disorders.
expand
This multi-modal methods study will investigate neurophysiological, endocrinological, cognitive, psycho-social-emotional markers of disease, and targets for integrative health treatments in mood disorders. Type: Interventional Start Date: Oct 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... 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 |
Efficacy of Guanfacine and Lidocaine Combination in Trigeminal Nerve Block for Pain Management in Trigeminal...
Trigeminal Neuralgia
A phenome-wide association study (PheWAS) identified an association between a loss of
function variant in the human alpha 2B adrenergic receptor gene and trigeminal nerve
disorders. Guanfacine is the oldest alpha-2 adrenergic agonist in clinical use and is
approved for hypertension... expand
A phenome-wide association study (PheWAS) identified an association between a loss of function variant in the human alpha 2B adrenergic receptor gene and trigeminal nerve disorders. Guanfacine is the oldest alpha-2 adrenergic agonist in clinical use and is approved for hypertension and attention deficit hyperactivity disorder. We hypothesize that guanfacine will be an effective adjunct to lidocaine for the treatment of neuropathic pain by enhancing and prolonging pain relief due to its activation of alpha-2 adrenergic receptors. The objectives of the study will be to evaluate the efficacy and safety of guanfacine in combination with lidocaine for trigeminal nerve block procedures for pain management in trigeminal neuralgia patients. This study will evaluate the efficacy of guanfacine in reducing acute pain and extending duration of pain relief when delivered in combination with lidocaine as a trigeminal nerve block, measured by Visual Analog Scale (VAS) data collected at specific time points after each injection. Type: Interventional Start Date: Nov 2019 |
Saroglitazar Magnesium for the Treatment of Nonalcoholic Steatohepatitis With Fibrosis
Nonalcoholic Steatohepatitis
Fibrosis
Saroglitazar Magnesium for the Treatment of Nonalcoholic Steatohepatitis
expand
Saroglitazar Magnesium for the Treatment of Nonalcoholic Steatohepatitis Type: Interventional Start Date: Aug 2021 |
18 Month Prospective Efficacy and Safety Study of Bimatoprost Intracameral Implant (DURYSTA)
Open-angle Glaucoma
Ocular Hypertension
Study to collect effectiveness and safety data after administration of a bimatoprost
intracameral implant in patients with open-angle glaucoma (OAG) or ocular hypertension (OHT).
expand
Study to collect effectiveness and safety data after administration of a bimatoprost intracameral implant in patients with open-angle glaucoma (OAG) or ocular hypertension (OHT). Type: Observational Start Date: Mar 2021 |
Metabolic Effects of Angiotensin-(1-7)
Obesity
Insulin Resistance
Hypertension
Metabolic Cardiovascular Syndrome
The overall purpose of this study is to learn more about the metabolic effects of
angiotensin-(1-7) in the insulin resistant state associated with obesity. Pharmacologic
approaches to increase angiotensin-(1-7) levels or its actions are currently in development
for treatment... expand
The overall purpose of this study is to learn more about the metabolic effects of angiotensin-(1-7) in the insulin resistant state associated with obesity. Pharmacologic approaches to increase angiotensin-(1-7) levels or its actions are currently in development for treatment of metabolic-related diseases such as obesity and type II diabetes, based on findings from animal studies. It is unclear if this peptide contributes to the regulation of metabolism in humans. The investigators will test if angiotensin-(1-7) infusion can improve insulin sensitivity measured by hyperinsulinemic-euglycemic clamp methods in individuals with obesity and insulin resistance. The investigators will also examine for changes in blood pressure and related hemodynamic and hormonal changes following angiotensin-(1-7) infusion. Type: Interventional Start Date: Feb 2016 |
American Lung Association (ALA) Lung Health Cohort
Lung Diseases
The ALA-LHC is a longitudinal, multi-center cohort study that will enroll approximately 4,000
young adults between the ages of 25-35 who do not have severe lung disease. The overarching
objective of the ALA-LHC is to establish a national cohort of young adults for the purpose of... expand
The ALA-LHC is a longitudinal, multi-center cohort study that will enroll approximately 4,000 young adults between the ages of 25-35 who do not have severe lung disease. The overarching objective of the ALA-LHC is to establish a national cohort of young adults for the purpose of defining lung health and developing targets to intercept chronic lung disease at its earliest stages. Type: Observational Start Date: Oct 2021 |
AHEAD 3-45 Study: A Study to Evaluate Efficacy and Safety of Treatment With Lecanemab in Participants...
Preclinical Alzheimer's Disease
Early Preclinical Alzheimer's Disease
The primary purpose of this study is to determine whether treatment with lecanemab is
superior to placebo on change from baseline of the Preclinical Alzheimer Cognitive Composite
5 (PACC5) at 216 weeks of treatment (A45 Trial) and to determine whether treatment with
lecanemab... expand
The primary purpose of this study is to determine whether treatment with lecanemab is superior to placebo on change from baseline of the Preclinical Alzheimer Cognitive Composite 5 (PACC5) at 216 weeks of treatment (A45 Trial) and to determine whether treatment with lecanemab is superior to placebo in reducing brain amyloid accumulation as measured by amyloid positron emission tomography (PET) at 216 weeks of treatment (A3 Trial). Type: Interventional Start Date: Jul 2020 |
Medication Treatment for Opioid Use Disorder in Expectant Mothers
Opioid-Related Disorders
Drug Addiction
Pregnancy Related
Substance Abuse
Drug Abuse
The primary objective of this study is to evaluate the impact of treating opioid use disorder
(OUD) in pregnant women with extended-release buprenorphine (BUP-XR), compared to sublingual
buprenorphine (BUP-SL), on mother and infant outcomes. The primary hypothesis is that the... expand
The primary objective of this study is to evaluate the impact of treating opioid use disorder (OUD) in pregnant women with extended-release buprenorphine (BUP-XR), compared to sublingual buprenorphine (BUP-SL), on mother and infant outcomes. The primary hypothesis is that the BUP-XR group will not have greater illicit opioid use than the BUP-SL group during pregnancy (non-inferiority). Type: Interventional Start Date: Jul 2020 |
Neural Correlates of Sensory Phenomena in Tourette Syndrome
Tourette Syndrome
Sensory Disorders
Hypersensitivity
Tics
The most pervasive sensory manifestation of TS is sensory over-responsivity (SOR). SOR is
defined as excessive behavioral response to commonplace environmental stimuli. SOR is an
integral but poorly understood facet of the TS phenotype, one intertwined with core elements
of... expand
The most pervasive sensory manifestation of TS is sensory over-responsivity (SOR). SOR is defined as excessive behavioral response to commonplace environmental stimuli. SOR is an integral but poorly understood facet of the TS phenotype, one intertwined with core elements of the disorder and worse QOL. This proposal seeks to clarify the mechanistic bases of SOR in TS. Adults with with TS will be recruited 1) to complete a standardized clinical symptom assessment battery and 2) to undergo electroencephalogram (EEG), autonomic, and audio-visual monitoring during tactile and auditory stimuli paradigms, as well as at rest. Type: Observational Start Date: Jul 2021 |
Dietary Salt in Rheumatoid Arthritis
Rheumatoid Arthritis
In this study investigators propose to address the following hypotheses: 1) Reduction in
dietary sodium will decrease inflammation in patients with rheumatoid arthritis (RA). 2)
Reduction in dietary sodium will decrease blood pressure in patients with RA. 3) Reduction in
dietary... expand
In this study investigators propose to address the following hypotheses: 1) Reduction in dietary sodium will decrease inflammation in patients with rheumatoid arthritis (RA). 2) Reduction in dietary sodium will decrease blood pressure in patients with RA. 3) Reduction in dietary sodium will decrease tissue sodium in patients with RA. Type: Interventional Start Date: Jan 2020 |
PrecISE (Precision Interventions for Severe and/or Exacerbation-Prone Asthma) Network Study
Asthma
The primary objective of this study is to evaluate several interventions given to
participants with severe asthma. Interventions are administered in a crossover manner with
16-week treatment periods followed by 8 to 16 week washout.
expand
The primary objective of this study is to evaluate several interventions given to participants with severe asthma. Interventions are administered in a crossover manner with 16-week treatment periods followed by 8 to 16 week washout. Type: Interventional Start Date: Dec 2019 |
Executive Function in Early Childhood
Reading Disability
Despite the fact that a substantial number of school age children struggle with both reading
and math acquisition, the brain mechanisms of the overlapping aspects of reading and math
skills, thought in part to be linked via executive functions (EF), have not been unpacked.... expand
Despite the fact that a substantial number of school age children struggle with both reading and math acquisition, the brain mechanisms of the overlapping aspects of reading and math skills, thought in part to be linked via executive functions (EF), have not been unpacked. This project will use a longitudinal design, following children from Kindergarten through 1st grade, to understand how the brain networks associated with reading, math, and EF interact to predict academic outcomes and, in those who struggle academically, intervention response. Type: Interventional Start Date: Aug 2019 |
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