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Stereotactic Radiosurgery for Essential Tremor and Parkinsonian Tremor
Vanderbilt University Medical Center
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... 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
open study
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Meeting an Unmet Need in Multiple Sclerosis
Kessler Foundation
Multiple Sclerosis
The primary objectives of this study is to examine the efficacy of the Unified Protocol in
decreasing depression and anxiety among individuals with MS and the secondary outcomes (e.g.,
improved well-being, QOL, coping, etc.) that may occur in tandem.
expand
The primary objectives of this study is to examine the efficacy of the Unified Protocol in
decreasing depression and anxiety among individuals with MS and the secondary outcomes (e.g.,
improved well-being, QOL, coping, etc.) that may occur in tandem.
Type: Interventional
Start Date: Apr 2023
open study
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Correlates of CRCI and Gut Microbiome Dysbiosis; a Pilot Study
The University of Texas Medical Branch, Galveston
Cancer
The aim of this study is to characterize the microbiome and assess fatigue and cognition of
patients with cancer undergoing standard of care treatment.
expand
The aim of this study is to characterize the microbiome and assess fatigue and cognition of
patients with cancer undergoing standard of care treatment.
Type: Observational
Start Date: Mar 2024
open study
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Randomized Study in Children and Adolescents With Migraine: Acute Treatment
Pfizer
Pediatric Migraine
The purpose of this study is to test the safety and efficacy of BHV-3000 versus placebo in
the acute treatment of moderate or severe migraine in children and adolescents.
expand
The purpose of this study is to test the safety and efficacy of BHV-3000 versus placebo in
the acute treatment of moderate or severe migraine in children and adolescents.
Type: Interventional
Start Date: Jan 2021
open study
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Alzheimer's Disease Neuroimaging Initiative 3 (ADNI3)
University of Southern California
Mild Cognitive Impairment (MCI)
Alzheimer's Disease (AD)
Since its launch in 2004, the overarching aim of the Alzheimer's Disease Neuroimaging
Initiative (ADNI) has been realized in informing the design of therapeutic trials in AD.
ADNI3 continues the previously funded ADNI-1, ADNI-GO, and ADNI-2 studies that have been
combined... expand
Since its launch in 2004, the overarching aim of the Alzheimer's Disease Neuroimaging
Initiative (ADNI) has been realized in informing the design of therapeutic trials in AD.
ADNI3 continues the previously funded ADNI-1, ADNI-GO, and ADNI-2 studies that have been
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 Alzheimer's disease (AD). The overall goal of the
study is to continue to discover, optimize, standardize, and validate clinical trial measures
and biomarkers used in AD research.
Type: Observational
Start Date: Oct 2016
open study
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Bone Marrow and Peripheral Blood Immune Responses Study
Emory University
Influenza
The purpose of this study is to evaluate the immune response of the killed flu vaccine in
healthy subjects. Participants in this study are considered to be healthy volunteers.
Influenza ("Flu") infection carries a risk of serious illness.
This is an open label and single... expand
The purpose of this study is to evaluate the immune response of the killed flu vaccine in
healthy subjects. Participants in this study are considered to be healthy volunteers.
Influenza ("Flu") infection carries a risk of serious illness.
This is an open label and single arm observational study designed to assess the humoral
response to influenza vaccination and the longevity of humoral immunity to influenza
vaccination in healthy adults.
Enrolled subjects will receive licensed seasonal inactivated influenza vaccine (administered
as a part of the study). Participants will donate serial samples of blood and bone marrow
aspirate for immunology monitoring. Repeated measurements of humoral immunity will be
obtained at 7 days, 28 days, 90 days and at one year post vaccination to assess the
magnitude, clonal diversity and persistence of B-cell responses to influenza vaccination.
Type: Interventional
Start Date: Oct 2023
open study
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Observational Digital Biomarker Discovery in Respiratory Virus Challenge Studies
National Institute of Allergy and Infectious Diseases (NIAID)
Influenza
Respiratory Virus
Coronavirus
Background:
Respiratory viruses circulate throughout the year and around the globe. Wearable and sensor
devices, like smartwatches, may be able to help monitor infectious diseases. Researchers want
to use them to learn how respiratory viruses affect people in different ways.... expand
Background:
Respiratory viruses circulate throughout the year and around the globe. Wearable and sensor
devices, like smartwatches, may be able to help monitor infectious diseases. Researchers want
to use them to learn how respiratory viruses affect people in different ways.
Objective:
To use digital devices to collect data from participants in challenge studies that could
indicate subtle changes in health during an infection that might otherwise go unnoticed.
Eligibility:
Healthy adults who have enrolled in a challenge study.
Design:
Participants will stay at NIH for at least 9 days and then they will have outpatient visits.
While at NIH, participants will wear a smartwatch at all times. It will record data like
temperature, heart rate, breathing rate, and movements.
Participants will have 2 smartphones. One will be recording at all times to listen for
coughing. Participants will use the other smartphone to check their vital signs. They will
collect data like heart rate, temperature, and the level of oxygen in the blood every 4 hours
during the daytime.
Participants will perform tasks every 4 hours during the daytime. They will record themselves
coughing, breathing in deeply, and reading aloud. They will take pictures and videos of their
face.
A bedside sensor will record participants while they sleep. It will record heart rate and
breathing rate. It will also look at sleep activity, such as movements participants make
during sleep and how deeply they sleep.
Participants sharing the same room will be exposed to the same challenge virus.
For outpatient visits, participants will use one smartphone and the smartwatch to complete
the above tasks.
Participation will last from 10 weeks to 1 year.
Type: Observational
Start Date: Oct 2023
open study
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Hyperbaric Oxygen Brain Injury Treatment Trial
Hennepin Healthcare Research Institute
Traumatic Brain Injury
The purpose of this innovative adaptive phase II trial design is to determine the optimal
combination of hyperbaric oxygen treatment parameters that is most likely to demonstrate
improvement in the outcome of severe TBI patients in a subsequent phase III trial.
expand
The purpose of this innovative adaptive phase II trial design is to determine the optimal
combination of hyperbaric oxygen treatment parameters that is most likely to demonstrate
improvement in the outcome of severe TBI patients in a subsequent phase III trial.
Type: Interventional
Start Date: Jun 2018
open study
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Telehealth Pain Self-Management for Employed Adults
University of Washington
Chronic Pain
Brain Injuries, Traumatic
Multiple Sclerosis
Spinal Cord Injuries
Amputation
The E-TIPS trial will evaluate an evidence-based, telehealth pain self-management
intervention compared to standard care (a waitlist) for chronic pain in adults with physical
disabilities who are employed. Participants from anywhere in the US will be randomized to
either E-TIPS,... expand
The E-TIPS trial will evaluate an evidence-based, telehealth pain self-management
intervention compared to standard care (a waitlist) for chronic pain in adults with physical
disabilities who are employed. Participants from anywhere in the US will be randomized to
either E-TIPS, a cognitive-behavioral pain self-management intervention delivered by
telephone, or a waitlist control. Outcomes, including pain interference, will be assessed at
baseline, mid-treatment, post-treatment, and 6-month follow up.
Type: Interventional
Start Date: Mar 2020
open study
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Effects of Treatments on Atopic Dermatitis
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Eczema
Dermatitis
Skin Diseases, Genetic
Dermatitis, Atopic
Skin Diseases
Background:
- Atopic dermatitis, or eczema, is a chronic skin disorder. Patients sometimes have
infections with S. aureus bacteria. Researchers want to study how eczema treatments affect
the number and the type of bacteria on the skin.
Objectives:
- To... expand
Background:
- Atopic dermatitis, or eczema, is a chronic skin disorder. Patients sometimes have
infections with S. aureus bacteria. Researchers want to study how eczema treatments affect
the number and the type of bacteria on the skin.
Objectives:
- To study the effect of eczema treatments on skin bacteria.
Eligibility:
- Individuals between 2 and 25 years of age who have moderate to severe atopic dermatitis.
- Healthy volunteers between 18 and 40 years of age with no history of eczema.
Design:
- Participants will be screened with a physical exam and medical history. Research samples
will be collected. Skin biopsies may also be performed.
- All participants will be assigned to one of several study groups.
- This study will last for up to 1 year. Healthy volunteers must not have taken
antibiotics in the year before the start of the study.
- All participants will have regular study visits during their 1-year participation. More
research samples will be collected at these visits.
Type: Interventional
Start Date: Sep 2012
open study
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Strengthening Circadian Signals
Northwestern University
Improving Cardiometabolic Outcomes in Adults
There is a growing body of evidence from both laboratory and field studies that disrupted
circadian function, particularly decreased amplitude and stability of rhythmic behaviors
represent significant risk factors for cardiometabolic disease (CMD) in humans. The exciting
evidence... expand
There is a growing body of evidence from both laboratory and field studies that disrupted
circadian function, particularly decreased amplitude and stability of rhythmic behaviors
represent significant risk factors for cardiometabolic disease (CMD) in humans. The exciting
evidence of the ubiquity of circadian clocks in all tissues and their critical role in
metabolism, not only opens up new avenues for understanding the mechanistic interactions
between central and peripheral clocks in cardiometabolic disease pathogenesis, but also to
develop therapeutic interventions to re-establish synchrony between central and peripheral
clocks with each other and with the external physical and social environments. Feeding has
been shown to synchronize clocks in peripheral tissues. Animal studies have demonstrated that
restricting feeding to the active period decreases CMD risk, while in humans decreased
caloric intake in the evening is associated with a lower body mass index (BMI). The amplitude
of melatonin can be considered a marker of robustness of central circadian function, but
melatonin also has physiological effects beyond circadian regulation throughout the body.
Recent observations have demonstrated that having a low melatonin level is a risk factor for
incident diabetes and hypertension independent of sleep duration. Together, the evidence
suggests that strategies aimed at synchronizing feeding behavior and enhancing the nocturnal
melatonin signal can positively impact cardiometabolic function.
We propose to take an innovative approach that combines the recent data on the role of
feed/fast patterns on clock regulated metabolic activity and the reemergence of scientific
interest of the central and peripheral effects of melatonin on cardiometabolic function to
elucidate the physiological and molecular mechanisms that underlie the relationship between
circadian dysregulation and obesity associated CMD risk. This will be accomplished by
strengthening the amplitude of circadian metabolic signals via meal timing and enhancement of
nocturnal circadian signaling with exogenous melatonin in overweight and obese middle aged
and older adults. In addition, this study will provide crucial information regarding the
importance of circadian timing for the design of future clinical trials on CMD in overweight
and obese adults. This is a critical time in the lifespan when circadian based strategies for
prevention and treatment are most likely to have the greatest impact on CMD risk. This
project will enroll 100 adults (40-54 years) to participate in a parallel (4 arm
intervention) placebo controlled study to determine whether a six- week program of meal
timing and/or low dose (1 mg) melatonin administration will enhance circadian amplitude and
enhance cardiometabolic function, as well as to evaluate the potential beneficial effects of
a regimen that combines both approaches. The results from this study will demonstrate novel
mechanistically based approaches for maintaining and improving circadian-metabolic health
during a critical time in the lifespan when there is a rapid increase in the prevalence of
CMD.
Type: Interventional
Start Date: May 2018
open study
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Building Emotional Self-Awareness Teletherapy (BEST)
Indiana University
Concussion, Mild
Concussion, Brain
Concussion, Severe
Concussion, Intermediate
Concussion; Syndrome
To examine the feasibility, acceptability, and preliminary efficacy of a remotely delivered
intervention for civilians and service members with mild traumatic brain injury (mTBI) who
have difficulty recognizing and regulating their emotions. Post-treatment outcomes of
interest... expand
To examine the feasibility, acceptability, and preliminary efficacy of a remotely delivered
intervention for civilians and service members with mild traumatic brain injury (mTBI) who
have difficulty recognizing and regulating their emotions. Post-treatment outcomes of
interest include emotional self-awareness and regulation, resiliency, and affective symptoms.
Type: Interventional
Start Date: Feb 2023
open study
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Gut Microbial Metabolites of Apple Polyphenols
University of Maryland, College Park
Healthy
Controlled Feeding Trial
The goal of this controlled feeding trial is to learn about the metabolism of polyphenols, a
common class of compounds found in plant-based foods, by the gut microbiome. It will evaluate
how differences in gut bacteria across individuals influence metabolism of polyphenols from... expand
The goal of this controlled feeding trial is to learn about the metabolism of polyphenols, a
common class of compounds found in plant-based foods, by the gut microbiome. It will evaluate
how differences in gut bacteria across individuals influence metabolism of polyphenols from
foods, which may influence health benefits that people receive from different foods.
Type: Interventional
Start Date: Jan 2024
open study
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Brain Health & the Microbiome
George Washington University
Mild Cognitive Impairment
Mild Dementia
Alzheimer Disease 1
The GW SMHS supports research in complementary and integrative approaches to treatment of
sickness and disease and for health promotion. Sometimes, research may involve asking
questions of patients, students, and health providers. In this study, individuals are being
asked... expand
The GW SMHS supports research in complementary and integrative approaches to treatment of
sickness and disease and for health promotion. Sometimes, research may involve asking
questions of patients, students, and health providers. In this study, individuals are being
asked to participate in this study as either 1) a healthy volunteer, 2) a person with Mild
Cognitive Impairment (MCI), or 3) a person with early Alzheimer's disease (eAD). We are
trying to learn more about if the gut microbiome (the microbes that live in our digestive
tract) of individuals with eAD, MCI, and healthy controls are altered following lifestyle
changes. This research will provide the pilot data to begin to understand if these changes in
the gut microbiome are beneficial to health and/or may slow or halt the progression of MCI or
early Alzheimer's.
Type: Observational
Start Date: Aug 2023
open study
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Randomized Trial on Mobile Technology and Young Drivers' Cellphone Use
Motao Zhu
Cell Phone Use
Automobile Driving
The purpose of this study is to conduct a randomized controlled trial to determine the
effects of a cellphone app and a driving mode intervention on driving behavior in drivers
aged 18-24 years.
expand
The purpose of this study is to conduct a randomized controlled trial to determine the
effects of a cellphone app and a driving mode intervention on driving behavior in drivers
aged 18-24 years.
Type: Interventional
Start Date: Nov 2022
open study
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Aging Program Project Grant 6
Northwestern University
Improving Cardiometabolic Outcomes in Older Adults
This study aims to enhance circadian signals to improve cardiometabolic functions in older
adults though meal timing interventions and melatonin supplements. Cardiometabolic disease
(CMD) is prevalent among older adults, but despite vigorous research to prevent it, it
remains... expand
This study aims to enhance circadian signals to improve cardiometabolic functions in older
adults though meal timing interventions and melatonin supplements. Cardiometabolic disease
(CMD) is prevalent among older adults, but despite vigorous research to prevent it, it
remains on of the greatest public health challenges. Previous research has shown that
extended overnight fasting and melatonin supplements may enhance circadian signals which in
turn would enhance cardiometabolic function in older adults.
This study will place subjects in one of four intervention groups, 1) Meal timing +
Melatonin, 2) Meal timing + Placebo, 3) Melatonin, or 4) Placebo in order test out the
effects of meal timing and melatonin both separately and together and cardio metabolic
functions. The study will explore the effects of these interventions in acute-based setting
and extended-based settings. This will allow us to test out the hypotheses of the study that
meal timing can improve amplitude of circadian signals and improve cardiometabolic functions
and sleep quality as well as melatonin improving cardiometabolic function and sleep quality.
Finally, we will determine if the the addition of melatonin will further enhance the effects
of the meal timing intervention for improving cardiometabolic function and sleep.
Type: Interventional
Start Date: Mar 2018
open study
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Study of BOTOX Injections to Assess Change in Disease Activity and Adverse Events in Adult Female Participants...
Allergan
Interstitial Cystitis/Bladder Pain Syndrome (IC/BPS)
Interstitial Cystitis/Bladder Pain Syndrome (IC/BPS) is a chronic and debilitating urological
complex of disorders characterized by symptoms of bladder pain or discomfort, mostly upon
bladder filling, and often accompanied by lower urinary tract symptoms (LUTS). This study... expand
Interstitial Cystitis/Bladder Pain Syndrome (IC/BPS) is a chronic and debilitating urological
complex of disorders characterized by symptoms of bladder pain or discomfort, mostly upon
bladder filling, and often accompanied by lower urinary tract symptoms (LUTS). This study
will assess how safe and effective BOTOX (onabotulinumtoxinA) is in treating IC/BPS. Adverse
events and change in disease symptoms will be evaluated.
BOTOX (onabotulinumtoxinA) is an investigational drug being developed for the treatment of
Interstitial Cystitis/Bladder Pain Syndrome (IC/BPS). Study doctors randomly assign the
participants to 1 of 2 groups, called treatment arms, to receive BOTOX or placebo. There is a
1 in 2 chance that participants will be assigned to placebo. Approximately 80 female
participants, aged 18 to 75 years, with a diagnosis of IC/BPS will be enrolled in
approximately 40 sites in the United States and Canada.
Participants will receive BOTOX or placebo injected into the bladder on Day 1 and will be
followed for at least 12 weeks in treatment 1. Eligible participants may request additional
dose of BOTOX between Weeks 12 and 24, and will be followed for 12 weeks in treatment period
2.
There may be higher treatment burden for participants in this trial compared to their
standard of care. Participants will attend regular visits during the study at a hospital or
clinic. The effect of the treatment will be checked by medical assessments, blood tests,
checking for side effects and completing questionnaires.
Type: Interventional
Start Date: Mar 2022
open study
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Essential Fats For Enhancing Cognitive Thinking (EFFECT) Study
Ohio State University
Cognitive Decline
Cognitive Impairment
The proposed research is a randomized crossover trial designed to assess changes in
postprandial cognitive function and the gut-brain axis in adults with subjective cognitive
complaints who consume 1 study snack per day for 1 week.
expand
The proposed research is a randomized crossover trial designed to assess changes in
postprandial cognitive function and the gut-brain axis in adults with subjective cognitive
complaints who consume 1 study snack per day for 1 week.
Type: Interventional
Start Date: Feb 2024
open study
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Fully Closed Loop at Home (FCL@Home)
Gregory Forlenza
Type 1 Diabetes
Protocol Overview/Synopsis This study will be conducted at 3 sites, with each site performing
a session with up to 6 participants with a lower HbA1c (<8.0%) in one of 3 age categories
(26-60, 18-25, or 14-17 years) followed by a session of up to 6 additional participants with... expand
Protocol Overview/Synopsis This study will be conducted at 3 sites, with each site performing
a session with up to 6 participants with a lower HbA1c (<8.0%) in one of 3 age categories
(26-60, 18-25, or 14-17 years) followed by a session of up to 6 additional participants with
a higher HbA1c (8.0-12.0%) with the same age categories (26-60, 18-25, or 14-17 years). The
trial will aim to complete a total of 36 participants: 12 total participants within each age
category and 18 participants within each HbA1c category; 12 participants at each site. The
study may enroll up to 70 participants to account for dropouts across the study. The study
will be performed for 5 days and 4 nights at a local hotel/rental. Following the hotel
session, participants will undergo a 7 day/6-night remote monitored at-home use session. The
study will also conduct a two-week control period gathering data on glycemic control and
insulin administration with the participants usual care therapy. Participants will be
randomized 1:1, stratified by age cohort, to either group A (control period prior to AIDANET
use) or group B (control period after AIDANET use).
Type: Interventional
Start Date: Nov 2023
open study
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National Institute of Diabetes and Digestive Kidney Diseases* Share Plus: Continuous Glucose Monitoring...
University of Utah
Diabetes Mellitus, Type 1
The purpose of this study is to test the Share plus intervention aimed at improving the use
of data sharing between people with diabetes and their care partners in order to maximize the
benefits of continuous glucose monitoring.
Hypothesis: Compared to the control group,... expand
The purpose of this study is to test the Share plus intervention aimed at improving the use
of data sharing between people with diabetes and their care partners in order to maximize the
benefits of continuous glucose monitoring.
Hypothesis: Compared to the control group, persons with diabetes enrolled in the Share plus
intervention group will experience clinically significant improvements in time-in-range (TIR)
(>5%) at 12- and 24-weeks into the study, and improvement on diabetes distress. Care partners
enrolled in the Share plus intervention group will experience lower diabetes distress at 12-
and 24-weeks into the study.
Type: Interventional
Start Date: Nov 2023
open study
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Efficacy and Safety of ATX01 in Adult Patients With CIPN (Chemotherapy-induced Peripheral Neuropathy)
AlgoTherapeutix
Chemotherapy-induced Peripheral Neuropathy
The purpose of this clinical trial is to compare the efficacy of twice daily applications of
ATX01 (10% & 15%) versus placebo during a 12-week treatment period in treating
chemotherapy-induced peripheral neuropathy (CIPN) in adult cancer survivor patients.
expand
The purpose of this clinical trial is to compare the efficacy of twice daily applications of
ATX01 (10% & 15%) versus placebo during a 12-week treatment period in treating
chemotherapy-induced peripheral neuropathy (CIPN) in adult cancer survivor patients.
Type: Interventional
Start Date: Feb 2023
open study
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CatchU: A Quantitative Multisensory Falls-Assessment Study
Jeannette Mahoney
Fall Injury
Age Problem
Well Aging
Sensory Disorders
The ability to successfully integrate information across sensory systems is a vital aspect of
functioning in the real world. To date, only a few studies have investigated the clinical
translational value of multisensory integration processes. Previous work has linked the
magnitude... expand
The ability to successfully integrate information across sensory systems is a vital aspect of
functioning in the real world. To date, only a few studies have investigated the clinical
translational value of multisensory integration processes. Previous work has linked the
magnitude of visual-somatosensory integration (measured behaviorally using simple reaction
time tasks) to important cognitive (attention) and motor (balance, gait, and falls) outcomes
in healthy older adults. While multisensory integration effects have been measured across a
wide array of populations using various sensory combinations and different neuroscience
approaches, a gold standard for quantifying multisensory integration has been lacking. The
investigator recently developed a step-by-step protocol for administering and calculating
multisensory integration effects in an effort to facilitate innovative and novel
translational research across diverse clinical populations and age-ranges. However, patients
with severe medical conditions and/or mobility limitations often experience difficulty
traveling to research facilities or joining time-demanding research protocols. Using the
aforementioned protocol, the study team invented a mobile multisensory falls-assessment
iPhone app called CatchU to facilitate physician discussion and counseling of falls in older
adults during clinical visits (e.g., annual wellness visits with a subsequent telehealth
call), in an attempt to alleviate disability, promote independence, and increase quality of
life for older adults. The investigator team has provided a cross-sectional research proposal
for a pilot study of 300 patients (over a 24-month period) in order to demonstrate
acceptable-to-excellent predicative accuracy of CatchU for identifying older adults at-risk
for falls.
Type: Interventional
Start Date: Oct 2022
open study
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Cardiovascular Analysis of PEM
Icahn School of Medicine at Mount Sinai
Myalgic Encephalomyelitis
Chronic Fatigue Syndrome
The purpose of this study is to examine cardiopulmonary function in Chronic Fatigue Syndrome
(CFS) patients and determine how it relates to the common symptom of Post-exertional malaise
(PEM). Subjects will complete a maximal exercise test on 2 subsequent days. Total blood... expand
The purpose of this study is to examine cardiopulmonary function in Chronic Fatigue Syndrome
(CFS) patients and determine how it relates to the common symptom of Post-exertional malaise
(PEM). Subjects will complete a maximal exercise test on 2 subsequent days. Total blood
volume will be measured prior to each exercise test, and patient with hypovolemia on day 1,
will be randomized to either a saline or sham infusion prior to the 2nd exercise test. A
total of 80 CFS patients will be enrolled.
Type: Interventional
Start Date: Aug 2021
open study
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Baricitinib for Reduction of HIV - CNS
William Tyor
Human Immunodeficiency Virus
There is still no cure for the human immunodeficiency virus (HIV). While combination
antiretroviral therapy (cART) is effective in decreasing deaths from HIV, infected
individuals face a lifetime of treatment and many potential complications including end organ
diseases such... expand
There is still no cure for the human immunodeficiency virus (HIV). While combination
antiretroviral therapy (cART) is effective in decreasing deaths from HIV, infected
individuals face a lifetime of treatment and many potential complications including end organ
diseases such as HIV-associated neurocognitive disorders. HIV infection is controllable with
antiretroviral therapy (ART), but ART cannot eliminate HIV reservoirs. Thus, there is no
available cure for HIV. There is a large and growing body of evidence that the central
nervous system (CNS) is an HIV reservoir site and a barrier to HIV eradication. Our group has
done extensive pre-clinical work with janus-kinase (JAK 1/2) inhibitors. This includes
baricitinib, which is an orally available, FDA-approved drug for rheumatoid arthritis.
Evidence suggests that this drug has activity against HIV in the central nervous system
(CNS). In our recently completed pilot study, we showed that baricitinib crosses the blood
brain barrier (BBB) and decreases HIV CNS persistence in the brain.
Using bloodwork, neurocognitive testing, MRIs and lumbar punctures, we plan to evaluate the
change in central nervous system HIV after treatment with baricitinib versus placebo. We will
also evaluate changes in neuroimaging, inflammation in blood and cerebrospinal fluid (CSF),
and neuropsychological performance after treatment with baricitinib versus placebo.
Evidence shows that the central nervous system is one of the reservoir sites that enables the
HIV virus to persist in the body even after years of treatment. In order to attack this
reservoir and eventually find a cure, it is vital to learn if certain medications can
suppress HIV in the CNS.
Type: Interventional
Start Date: May 2023
open study
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VICE-MPRINT: Maternal and Pediatric Pharmacogenetics Survey
Vanderbilt University Medical Center
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
open study
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