|
Leukapheresis Procedures to Obtain Plasma and Lymphocytes for Research Studies on Primary and Chron1
National Institute of Allergy and Infectious Diseases (NIAID)
HIV
There is evidence that early and aggressive treatment with antiretroviral drugs can
prevent the loss of immune cell function that accompanies HIV infection. This study will
use leukapheresis (drawing blood, separating out the white cells and returning the blood
to the patient) to obtain blood cells1 expand
There is evidence that early and aggressive treatment with antiretroviral drugs can
prevent the loss of immune cell function that accompanies HIV infection. This study will
use leukapheresis (drawing blood, separating out the white cells and returning the blood
to the patient) to obtain blood cells from HIV-infected patients in either the acute or
chronic stage of infection who are being treated with early highly active antiretroviral
therapy (HAART). Leukapheresis is necessary to obtain enough cells to delineate the
response of B cells to CD4+ T cell help, the CD8 factors associated with suppression of
viral replication and normalization of immune function, and natural killer function
relative to HIV disease.
Study participants will be adult (older than 18 years) HIV primary or acutely affected
patients (those with a history of exposure to HIV but not yet showing chronic symptoms of
HIV disease) and HIV chronically infected patients (those infected with HIV for longer
than 12 months or showing other symptoms of HIV disease) who are not receiving HAART at
the beginning of the study. The study seeks to enroll 30 primary and 30 chronic patients.
Pregnant women will not be enrolled in the study; women who become pregnant will be
dropped from the study.
Leukapheresis will be performed on each patient before HAART therapy begins and then
three times a year. Each session will take between 1 and 3 hours.
This longitudinal study will enable researchers to examine the function of certain B
cells, natural killer cells, and CD8+ T cells in people who do not have chronic HIV
disease and in those who do have the disease and are treated with HAART.
Type: Observational
Start Date: Jul 2002
open study
|
|
Cannabidiol as a Treatment for Social Anxiety Disorder (R61)
NYU Langone Health
Social Anxiety Disorder
The R61 will include two CBD dose levels vs placebo (PBO) and examine potential
engagement with two primary targets in a 3-week randomized controlled trial design.
Willing and eligible subjects will be randomized to one of three randomized double-blind
treatments (n = 20 each group): 1) CBD 800 mg1 expand
The R61 will include two CBD dose levels vs placebo (PBO) and examine potential
engagement with two primary targets in a 3-week randomized controlled trial design.
Willing and eligible subjects will be randomized to one of three randomized double-blind
treatments (n = 20 each group): 1) CBD 800 mg (400 mg twice daily), 2) CBD 400 mg (200 mg
twice daily), or 3) PBO twice daily for three weeks.
Participation is estimated at approximately 1 month from end of screening to endpoint for
the primary R61 study period. This includes screening, baseline, week 2 stress task, Week
3 2-day imaging paradigm, and clinical safety assessments at weeks 2 and 3.
Type: Interventional
Start Date: Jan 2023
open study
|
|
Brain Dopaminergic Signaling in Opioid Use Disorders
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Normal Physiology
Opioid Use Disorders
Background:
The chemical messenger dopamine carries signals between brain cells. It may affect
addiction. Heavy use of pain medicines called opioids may decrease the amount of dopamine
available to the brain. Researchers want to study if decreased dopamine decreases
self-control and increases impu1 expand
Background:
The chemical messenger dopamine carries signals between brain cells. It may affect
addiction. Heavy use of pain medicines called opioids may decrease the amount of dopamine
available to the brain. Researchers want to study if decreased dopamine decreases
self-control and increases impulsiveness.
Objective:
To learn more about how opiate use disorder affects dopamine in the brain.
Eligibility:
Adults 18-80 years old who are moderate or severe opiate users
Healthy volunteers the same age
Design:
Participants will first be screened under another protocol. They will:
- Have a physical exam
- Answer questions about their medical, psychiatric, and alcohol and drug use history
- Take an MRI screening questionnaire
- Give blood and urine samples
- Have their breath tested for alcohol
Participants will have up to 3 study visits.
They will have 2-3 positron emission tomography (PET) scans. A radioactive chemical will
be injected for the scans. Participants will lie on a bed that slides in and out of the
donut-shaped scanner. A cap or plastic mask may be placed on the head.
Vital signs will be taken before and after the PET scans.
Participants will get capsules of placebo or the study drug. They will rate how they feel
before, during and after.
Participants will have their breath and urine tested each day.
Participants will have magnetic resonance imaging (MRI) scans. They will lie on a table
that slides into a cylinder in a strong magnetic field. They may do tasks on a computer
screen while inside the scanner.
Participants will have tests of memory, attention, and thinking.
Participants will wear an activity monitor for one week....
Type: Interventional
Start Date: Aug 2017
open study
|
|
Safety and Immunogenicity of Recombinant Varicella Zoster Virus Vaccine in People With HIV Who Have1
National Institute of Allergy and Infectious Diseases (NIAID)
Herpes Zoster
Background:
Shingles is a painful, blistering rash caused by the same virus that causes chickenpox.
Shingrix is a vaccine approved to prevent shingles in healthy adults over age 50 and in
immunocompromised adults over age 18. Researchers want to learn more about how people
with HIV respond to Shin1 expand
Background:
Shingles is a painful, blistering rash caused by the same virus that causes chickenpox.
Shingrix is a vaccine approved to prevent shingles in healthy adults over age 50 and in
immunocompromised adults over age 18. Researchers want to learn more about how people
with HIV respond to Shingrix.
Objective:
To learn how Shingrix affects the immune response in people with HIV.
Eligibility:
People aged 18 years and older with HIV. Healthy people aged 50 years or older are also
needed.
Design:
Participants will have at least 4 clinic visits in 1 year.
Participants will be screened. They will have a physical exam with blood and urine tests.
At their first visit, participants will receive Shingrix as a shot in the upper arm. They
will have a rectal swab; a cotton swab will be inserted into the rectum and rotated
gently to collect bacteria.
Participants will receive a second shot of Shingrix 2 months after the first one. They
will visit the clinic again 3 and 12 months after the first shot.
Participants will receive a 28-day memory tool. They will write down their symptoms
between clinic visits. They will have up to 4 phone calls to talk about side effects of
the shot.
Participants may undergo apheresis: They will lie still while blood is drawn from a
needle in one arm. The blood will pass through a machine that separates out the white
blood cells. The remaining blood will be given back through a second needle in their
other arm.
Type: Interventional
Start Date: Mar 2023
open study
|
|
Resiniferatoxin to Treat Severe Pain Associated With Advanced Cancer
National Institute of Dental and Craniofacial Research (NIDCR)
Intractable Pain
Palliative Care
This study will examine the safety of giving the experimental drug, resiniferatoxin
(RTX), to treat severe pain in patients with advanced cancer. RTX is a chemical extracted
from a cactus-like plant. It is similar to capsaicin, the active ingredient in hot
pepper. RTX has relieved pain and reduced1 expand
This study will examine the safety of giving the experimental drug, resiniferatoxin
(RTX), to treat severe pain in patients with advanced cancer. RTX is a chemical extracted
from a cactus-like plant. It is similar to capsaicin, the active ingredient in hot
pepper. RTX has relieved pain and reduced the need for pain medication in several animal
experiments. It works by destroying nerves that transmit pain information.
People at least 18 years of age with severe pain from advanced cancer at or below the
level of the chest that cannot be controlled with standard treatments may be eligible for
this study. Participants undergo the following procedures:
Pretreatment Visit
Before beginning treatment with RTX, patients give a medical history and undergo a
physical examination that includes:
- Electrocardiogram (EKG)
- Blood draw
- Urinalysis
- Neurological examinations
- Peak expiratory flow rate (PEFR)
- Eye examination
- MRI
- Urology assessment
- Pregnancy test, when appropriate
- Questionnaires to collect information on health, personality, mood, pain levels and
symptoms.
2-Day Hospitalization
Patients are hospitalized for 2 days for RTX injection and monitoring, as follows:
- RTX injection: RTX is injected in the operating room under general anesthesia. It is
given through a catheter placed in the patient s spine. The catheter is also used to
obtain samples of cerebrospinal fluid (CSF) the clear fluid that bathes the spinal
cord. The fluid is examined to assess drug effects and side effects, chemical
changes in the content of the CSF associated with RTX, and how RTX is handled by the
body.
- Post-injection monitoring, including:
- Surveys about symptoms such as pain or weakness
- Neurological examinations
- Blood and CSF sampling
- EKG
- AEs
Outpatient followup
- Vitals
- Blood draw, Urinalysis, neurological and sensory testing, EKG on days 7, 14 and 30
after the injection
- MRI scans of the head and back, Urology assessment and PEFR on day 15 after the
injection
- Eye examination
- Follow-up phone calls monthly for 6 months
Type: Interventional
Start Date: Aug 2009
open study
|
|
Urinary Vitamin C Loss in Diabetic Subjects
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Diabetes
Several studies have reported that diabetic subjects have lower plasma vitamin C
concentrations than non-diabetic subjects. Although urinary vitamin C loss in diabetic
subjects was reported to be increased in two studies, these are difficult to interpret
due to lack of controlled vitamin C intake,1 expand
Several studies have reported that diabetic subjects have lower plasma vitamin C
concentrations than non-diabetic subjects. Although urinary vitamin C loss in diabetic
subjects was reported to be increased in two studies, these are difficult to interpret
due to lack of controlled vitamin C intake, inadequate sampling, lack of control
subjects, or methodology uncertainties in vitamin C assay and sample processing.
Consequently, it is unclear whether diabetic subjects truly have both low plasma and high
urine vitamin C concentrations. We propose that low plasma vitamin C concentrations in
diabetic subjects are due in part to inappropriate renal loss of vitamin C in these
subjects but not in healthy controls. We will study nondiabetic controls and cohorts with
diabetes. Vitamin C concentrations in plasma, RBCs, and urine will be measured in
outpatients. In those willing to be admitted to the Clinical Center, we will measure
vitamin C pharmacokinetics to determine the relative bioavailability for vitamin C in
individuals with and without abnormal urinary loss of vitamin C (or renal leak). Single
nucleotide polymorphisms (SNPs) will be determined in genomic DNA responsible for the two
proteins mediating sodium dependent vitamin C transport, SVCT1 and SVCT2. We will also
explore mechanisms underlying abnormal urinary vitamin C loss....
Type: Observational
Start Date: Apr 2006
open study
|
|
Variability In Mixed Meal Tests: Fixed Versus Adjusted to Energy Needs Caloric Dose
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Obesity
Healthy Volunteer
Background:
Researchers use mixed meal tolerance tests (MMTTs) to look at how people s bodies respond
to eating a meal. However, researchers do not agree on how to decide the number of
calories to give in each meal. Some use fixed meals, which are the same size for
everyone, and some use adjusted1 expand
Background:
Researchers use mixed meal tolerance tests (MMTTs) to look at how people s bodies respond
to eating a meal. However, researchers do not agree on how to decide the number of
calories to give in each meal. Some use fixed meals, which are the same size for
everyone, and some use adjusted meals, based on the size of the person s body.
Researchers want to know which MMTT is best to use for future research.
Objective:
To learn how fixed vs adjusted meals affect blood glucose levels in healthy people.
Eligibility:
Healthy people aged 18 years or older.
Design:
Participants will have 3 or 4 clinic visits of up to 8 hours in 8 weeks.
Participants will have baseline tests:
Their height, weight, and waist size will be measured.
They will have an oral glucose tolerance test: A needle attached to a tube (IV) will be
inserted into a vein in the arm. They will have a sugary drink. Blood samples will be
taken from the tube at intervals up to 3 hours after the drink.
They will have a body scan.
Participants will have 2 MMTT visits. One will include a fixed meal and one will include
an adjusted meal. They will have tests at both visits:
Resting metabolic rate: A clear hood will be placed over the participant s head while
they rest for 20 minutes. This will measure the oxygen they breathe in and out.
MMTT. Participants will have 5 minutes to drink a liquid meal. Blood samples will be
taken at intervals for the next 4 hours....
Type: Interventional
Start Date: Aug 2024
open study
|
|
Environmental Risk Factors for the Anti-synthetase Syndrome
National Institute of Environmental Health Sciences (NIEHS)
Myositis
Dermatomyositis
Polymyositis
Juvenile Dermatomyositis
Juvenile Polymyositis
Background:
- Like other complex diseases, autoimmune diseases are the result of numerous causes,
including genetic and environmental factors. Some researchers believe that people
who are susceptible to autoimmune disorders develop them when the body reacts to
environmental or ot1 expand
Background:
- Like other complex diseases, autoimmune diseases are the result of numerous causes,
including genetic and environmental factors. Some researchers believe that people
who are susceptible to autoimmune disorders develop them when the body reacts to
environmental or other factors by creating white blood cells that attack the body s
own tissues, which then progresses to autoimmune diseases. These immune-triggered
disorders can overlap with one another to some extent, but most autoimmune diseases
have certain distinct triggers.
- The autoimmune disorder myositis weakens the muscles and may cause other health
problems. Environmental exposures associated with myositis include ultraviolet
radiation, stressful life events and muscle overexertion, collagen implants,
infections such as retroviruses and streptococci bacteria, and certain drugs and
chemicals. Some individuals with myositis also produce proteins in the blood called
autoantibodies that react with certain parts of the person s own cells, called
synthetases, which are involved in making new proteins. A syndrome called the
anti-synthetase syndrome, which includes myositis and lung disease, is associated
with having the anti-synthetase autoantibodies. Researchers are interested in
studying differences in environmental exposures in individuals with myositis. This
study is being conducted to determine if persons with the anti-synthetase syndrome
have had different environmental exposures before disease onset compared with other
patients with myositis who do not have this syndrome and also compared with healthy
volunteers.
Objectives:
- To determine whether selected infectious and noninfectious environmental exposures
are more common in individuals who have myositis with the anti-synthetase syndrome,
compared with healthy volunteers.
Eligibility:
- Individuals who have been diagnosed with myositis (with or without anti-synthetase
autoantibodies), and healthy volunteers without autoimmune disorders.
Design:
- Participants will be screened with a full medical history and physical examination,
and will provide blood, urine and house dust samples.
- Participants will complete questionnaires about their medical history and the types
of exposures they have had at work, at home, and elsewhere. Participants who have
myositis will also be asked about certain infections, heavy exercise or physical
exertion, sun exposure, tobacco and alcohol use, and stressful events prior to being
diagnosed with the disease. Healthy volunteers will be asked about the same
exposures before the date of diagnosis of disease of the myositis subject to which
they have been matched.
- Participants will receive a kit that contains instructions and a filter to be put
onto their vacuum cleaner to collect house dust in the bedroom. This dust will be
kept for possible future analyses of infectious or toxic agents based on the other
results from the study.
- Individuals with myositis will have other tests as clinically indicated, including
lung function tests and imaging studies.
Type: Observational
Start Date: Feb 2011
open study
|
|
Low-Dose Danazol for the Treatment of Telomere Related Diseases
National Heart, Lung, and Blood Institute (NHLBI)
Telomere Disease
Background:
DNA is a structure in the body. It contains data about how the body develops and works.
Telomeres are found on the end of chromosomes in DNA. Some people with short telomeres or
other gene changes can develop diseases of the bone marrow, lung, and liver. Researchers
want to see if low1 expand
Background:
DNA is a structure in the body. It contains data about how the body develops and works.
Telomeres are found on the end of chromosomes in DNA. Some people with short telomeres or
other gene changes can develop diseases of the bone marrow, lung, and liver. Researchers
want to see if low doses of the hormone drug danazol can help.
Objective:
To study the safety and effect of low dose danazol.
Eligibility:
People ages 3 and older with a telomere disease who have either very short telomeres and
a specific gene change. They must also show signs of aplastic anemia, lung, or liver
disease.
Design:
Participants will be screened in another protocol.
Participants will have:
- Medical history
- Physical exam
- Blood tests
- Lung exam. They will breathe into an instrument that records the amount and rate of
air breathed in and out over a period of time.
6-minute walking test.
- Abdominal ultrasound and liver scan. These tests use sound waves to measure the
fibrosis in the liver.
Some participants will have:
- Pregnancy test
- Small sample of the liver removed
- Bone marrow biopsy. The bone will be numbed and a small needle will take a sample of
the marrow.
All participants will have hormone levels checked.
All child participants will see a pediatric endocrinologist. Children may need to have a
hand x-ray.
We will monitor patients for 6 months before starting danazol.
Participants will take danazol by mouth twice a day for 1 year.
Participants must return to the clinic at 6 months and 12 months while on danazol and 6
months after stopping it. They will have blood and urine tests, a lung exam, abdominal
ultrasound, and liver scan.
Type: Interventional
Start Date: Feb 2018
open study
|
|
Smart-Phone Safety Behavior Fading Intervention for Appearance Concerns (Open ARSB Study)
Florida State University
Body Dysmorphic Disorder
Social Anxiety Disorder
Eating Disorders
The current study aims to explore the efficacy of a text message based safety behavior
fading intervention compared to a relaxing video intervention for appearance concerns. expand
The current study aims to explore the efficacy of a text message based safety behavior
fading intervention compared to a relaxing video intervention for appearance concerns.
Type: Interventional
Start Date: Apr 2025
open study
|
|
Proof of Concept and Dose-ranging Study of INDV-2000 in Individuals With Moderate to Severe Opioid1
Indivior Inc.
Opioid Use Disorder
The purpose of this study is to measure safety and efficacy and to determine
dose-response relationship for INDV-2000 in participants with moderate to severe Opioid
Use Disorder (OUD) who are new to treatment, have recently initiated or completed
short-term medically supervised withdrawal with tran1 expand
The purpose of this study is to measure safety and efficacy and to determine
dose-response relationship for INDV-2000 in participants with moderate to severe Opioid
Use Disorder (OUD) who are new to treatment, have recently initiated or completed
short-term medically supervised withdrawal with transmucosal (TM) buprenorphine, and are
interested in transitioning to a non opioid treatment.
Type: Interventional
Start Date: Jun 2024
open study
|
|
The REBALANCE Study - a Prospective, Multicenter, Randomized, Pivotal Study of the May Health System
May Health
Polycystic Ovary Syndrome
Infertility, Female
A Prospective, Multicenter, Randomized, Pivotal Study of the May Health System in
Transvaginal Ablation of Ovarian Tissue under Ultrasound Guidance in Women with
Infertility due to Polycystic Ovary Syndrome expand
A Prospective, Multicenter, Randomized, Pivotal Study of the May Health System in
Transvaginal Ablation of Ovarian Tissue under Ultrasound Guidance in Women with
Infertility due to Polycystic Ovary Syndrome
Type: Interventional
Start Date: Mar 2024
open study
|
|
Black Women's Life Experience On Cardiovascular Health Via Ongoing Monitoring
The University of Texas at Arlington
Cardiovascular Diseases
Heart Disease Risk Factors
This pilot study uses a state-of-the-science combination of remote behavioral monitoring,
real-time experience sampling, in-lab physiological assessments, and extraction of
neighborhood-level characteristics to (1) Examine the impact of daily experience (i.e.,
racial discrimination, affective state1 expand
This pilot study uses a state-of-the-science combination of remote behavioral monitoring,
real-time experience sampling, in-lab physiological assessments, and extraction of
neighborhood-level characteristics to (1) Examine the impact of daily experience (i.e.,
racial discrimination, affective states, stress) on health behaviors (i.e., physical
activity, sedentary behavior, sleep) at the intrapersonal level among Black women; (2)
Test the association between daily behaviors and impairments in biomarkers associated
with vascular function/health (i.e., augmented systemic inflammation and oxidative
stress, impaired peripheral/cerebral vascular function, increased large artery
stiffness), as well as the impact of daily experience on the relationship between
behaviors and vascular function; and (3) Explore the influence of neighborhood-level
characteristics (i.e., social environment factors: i.e., neighborhood income and poverty,
racial composition; and built environment context, such as park density and walkability)
on daily experience and health behaviors.
Type: Observational
Start Date: Mar 2024
open study
|
|
Pharyngeal Exercise (Plus Protein)
NYU Langone Health
Pre-Frail Older Adults
The swallowing muscles are prone to decreased strength and function as part of the
natural aging process which can lead to difficulty swallowing, malnutrition, and frailty.
Exercise and nutrition are powerful stimulators of muscular change. The proposed research
will investigate the effectiveness o1 expand
The swallowing muscles are prone to decreased strength and function as part of the
natural aging process which can lead to difficulty swallowing, malnutrition, and frailty.
Exercise and nutrition are powerful stimulators of muscular change. The proposed research
will investigate the effectiveness of a 12-week proactive regimen of swallowing exercises
(with or without daily protein supplement drinks) to improve the composition, force, and
physiology of the swallowing muscles and explore the relationship to overall health and
physical function in 80 community-dwelling older adults. Each participant will serve as
their own control for 12 weeks before being randomized to complete swallowing exercises
alone or swallowing exercises with protein drinks.
Type: Interventional
Start Date: May 2024
open study
|
|
Acceptability and Efficacy of Pain Reprocessing Therapy in Racially/ Ethnically Diverse Adults With1
University of Colorado, Denver
Pain, Chronic
Back Pain
The goal of this clinical trial is to learn which treatment works better for adults with
chronic pain. This study is comparing three treatments: Pain Reprocessing Therapy (PRT),
Cognitive Behavioral Therapy (CBT), and usual care (whatever a person is already doing to
cope with their pain).
The stu1 expand
The goal of this clinical trial is to learn which treatment works better for adults with
chronic pain. This study is comparing three treatments: Pain Reprocessing Therapy (PRT),
Cognitive Behavioral Therapy (CBT), and usual care (whatever a person is already doing to
cope with their pain).
The study's main questions are:
- Does PRT work well for adults with chronic pain?
- Which treatment works better for lowering pain: PRT, CBT, or usual care?
This study will compare PRT, CBT, and usual care to see which is most helpful for
lowering pain and helping with other problems that people with chronic pain can have.
Type: Interventional
Start Date: Apr 2023
open study
|
|
Matching Adults to Treatments for Chronic Pain (MATCH) Study
University of Washington
Chronic Pain
Chronic pain is a prevalent, disabling problem affecting as many as 50% of men and 75% of
women Veterans. Cognitive Behavioral Therapy (CBT) is the current gold standard treatment
for chronic pain. However, while some individuals do respond to CBT, many individuals do
not obtain meaningful benefit.1 expand
Chronic pain is a prevalent, disabling problem affecting as many as 50% of men and 75% of
women Veterans. Cognitive Behavioral Therapy (CBT) is the current gold standard treatment
for chronic pain. However, while some individuals do respond to CBT, many individuals do
not obtain meaningful benefit. As a result, the average response to CBT treatment in
groups of individuals with chronic pain is only modest.
To address the need for effective treatments, the investigators have developed and
adapted Complementary and Integrative Health (CIH) interventions such as
Mindfulness-Based Cognitive Therapy (MBCT) and Hypnotic Cognitive Therapy (HYP-CT) for
chronic pain management. Research shows these treatments are beneficial alternatives to
CBT. However, as with CBT, response to these treatments varies, and the investigators'
preliminary data suggests outcome variability is explained by a number of baseline
patient factors. Research is now needed to advance knowledge regarding the pre-treatment
patient factors (i.e., predictive markers) that moderate treatment outcome (i.e., patient
factors that interact with treatment condition to predict outcome). The findings from
this research will provide an empirical basis for developing patient-treatment matching
algorithms to prospectively match a given individual to the evidence-based treatment most
likely to be beneficial for them.
The investigators have initiated a program of research to identify the factors that
predict response to psychosocial pain treatments, including HYP-CT, MBCT, and CBT.
Preliminary findings suggest that predictive markers such as brain activity (e.g., alpha
and beta power, as measured by EEG), and the traits of mindfulness, hypnotizability, and
catastrophizing, will predict who benefits most from different treatments. For example,
post hoc analyses show that those who are "well-matched" to HYP-CT, based on the
identified baseline moderators, achieve twice the amount of pain reduction with
treatment, compared to those who are not well- matched. To confirm these findings,
prospective research is now needed. The findings from this study will provide a
foundation upon which to develop an assessment battery to identify critical values on
which to base algorithms for a priori matching of individual patients to different
treatments. This has the potential to substantially boost the typically modest average
effect sizes that are achieved when using a more traditional "one size fits all"
approach.
Type: Interventional
Start Date: Apr 2023
open study
|
|
Alzheimer's Disease Neuroimaging Initiative 4
University of Southern California
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
open study
|
|
EPPIC-Net: Novaremed Painful Diabetic Peripheral Neuropathy ISA
James P. Rathmell, MD
Painful Diabetic Neuropathy
The purpose of this study is to investigate the safety and efficacy of the current hard
gelatin capsule formulation of NRD135S.E1 80 mg once daily in the treatment of PDPN when
administered for 13 weeks. expand
The purpose of this study is to investigate the safety and efficacy of the current hard
gelatin capsule formulation of NRD135S.E1 80 mg once daily in the treatment of PDPN when
administered for 13 weeks.
Type: Interventional
Start Date: Sep 2022
open study
|
|
Breaking up Sedentary Time to Improve Glucose Control in a Population at Risk for Developing Type 21
University of Colorado, Denver
Pre-diabetes
Newly released guidelines recommend increased physical activity (PA) and reduced
sedentary behaviors (SB) to improve glycemia and prevent the onset and progression of
type 2 diabetes (T2D). Typically, 30-60 min bouts of PA are advocated per day. Although
this approach increases PA, it does not decr1 expand
Newly released guidelines recommend increased physical activity (PA) and reduced
sedentary behaviors (SB) to improve glycemia and prevent the onset and progression of
type 2 diabetes (T2D). Typically, 30-60 min bouts of PA are advocated per day. Although
this approach increases PA, it does not decrease the length of the sedentary periods
through the day. This is important because recent epidemiological data suggest that
frequently interrupting sedentary time improves glucose control even in people who
achieve the recommended levels of PA. Preliminary experimental data suggest that breaking
up prolonged sedentary time by performing multiple short bouts (5 min) of PA throughout
the day, may improve glycemia more than performing a single continuous bout of PA, and
thereby potentially be a novel strategy to prevent T2D. The improvement in glycemia was
observed even when the total amount of PA and total energy expenditure were matched,
suggesting that how and when PA is performed over the day may matter more than how much
PA is done. However, important gaps in knowledge remain including: (1) whether similar
benefits on glucose control would be observed in adults with prediabetes, a clinically
relevant population that is at high risk of developing T2D; (2) whether these effects are
sustained or diluted over time, and (3) what are the mechanistic underpinnings. To
address these gaps, the investigators propose to measure the acute and chronic effects of
PA breaks on glucose control and the underlying mechanisms in individuals at risk of
developing T2D. Sedentary men and women with prediabetes (n=66, 50% F) will be randomized
to either an intervention designed to interrupt SB with 5-min bouts of brisk walking
performed hourly for 9 hours/day, 5 days/week (BREAK) or a control condition consisting
of 45-min of brisk walking performed as a single daily continuous bout, 5 days/week
(ONE). The two 3-months interventions will be matched for total active time.
Type: Interventional
Start Date: Nov 2021
open study
|
|
Couples Lived Experience
NYU Langone Health
Alzheimer Disease
Dementia of Alzheimer Type
This is a longitudinal study with regular quantitative assessments of all participants
every six months for 3 years. The quantitative portion of the study will recruit couples,
consisting of individuals over the age of 65 who are in a committed relationship. Both
members of the couple must be willi1 expand
This is a longitudinal study with regular quantitative assessments of all participants
every six months for 3 years. The quantitative portion of the study will recruit couples,
consisting of individuals over the age of 65 who are in a committed relationship. Both
members of the couple must be willing to participate at baseline. The assessment is in
two parts. In the first part, each member of the couple will be asked the following:
demographic information, mental health history, self-reported physical and emotional
health, measures of emotional and mental health, personality, relationship and attachment
style, social support and self-efficacy. Then each member of the study couple will be
asked a series of questions to determine whether they consider themselves a caregiver. If
they do, individuals will be asked to respond to additional caregiver questionnaires.
Follow-ups will occur every six months for the study couples for a total of three years
from the baseline visit. Each visit, the entire assessment except for demographic
questions, will be re-administered to each individual in the couple. At the end of each
questionnaire battery, individuals will be screened for cognitive impairment and those
who are in the middle to advanced stages of dementia will no longer participate.
Recruitment will end when 600 individuals (300 couples,150 couples at each site) are
enrolled in the longitudinal portion of the study. All study visits will be conducted
virtually via Zoom or WebEx video conferencing. Analyses will be conducted to determine
the association between changes in dyadic relationship and changes in mental health and
cognitive outcomes, to elucidate how relationship characteristics impact health and
well-being as perceived by each member of the dyad.
Type: Observational
Start Date: Apr 2021
open study
|
|
Neuronal Effects of Exercise in Schizophrenia
University of Colorado, Denver
Schizophrenia
This study plans to learn more about how common drugs prescribed to individuals with
schizophrenia contribute to weight gain, as well as how exercise and diet impact appetite
and the brain's response to food. In this study, the investigators will be evaluating how
participants' brains respond to fo1 expand
This study plans to learn more about how common drugs prescribed to individuals with
schizophrenia contribute to weight gain, as well as how exercise and diet impact appetite
and the brain's response to food. In this study, the investigators will be evaluating how
participants' brains respond to food images as well as asking questions about their food
preferences and intake and clinical symptoms. The investigators may also ask participants
to complete an exercise or diet intervention to see how this changes brain responses or
food preferences.
Type: Interventional
Start Date: Aug 2014
open study
|
|
Magnetic Resonance Elastography as a Method to Estimate Stiffness of Soft Tissues
Arunark Kolipaka
Heart Failure
Liver Fibrosis
Cardiac Transplant Rejection
Aortic Aneurysms
Magnetic resonance elastography is a novel non-invasive MRI technique to obtain stiffness
of soft tissues such as liver, heart, kidneys, etc. In this imaging technique a person is
laid in an MR scanner and a paddle (plastic drum) is put on the area of interest to send
sound vibration via a speaker1 expand
Magnetic resonance elastography is a novel non-invasive MRI technique to obtain stiffness
of soft tissues such as liver, heart, kidneys, etc. In this imaging technique a person is
laid in an MR scanner and a paddle (plastic drum) is put on the area of interest to send
sound vibration via a speaker placed outside the scan room which is connecting plastic
drum via a plastic tube. These vibrations are scanned using MRI to estimate the stiffness
of soft tissues such as liver, heart, kidneys, breast etc.
Type: Observational
Start Date: Mar 2012
open study
|
|
Brain Imaging of Childhood Onset Psychiatric Disorders, Endocrine Disorders and Healthy Volunteers
National Institute of Mental Health (NIMH)
Attention Deficit Hyperactivity Disorder
Schizophrenia
Attention Deficit Disorder With Hyperactivity
Magnetic Resonance Imaging (MRI) unlike X-rays and CT-scans does not use radiation to
create a picture. MRI use as the name implies, magnetism to create pictures with
excellent anatomical resolution. Functional MRIs are diagnostic tests that allow doctors
to not only view anatomy, but physiology an1 expand
Magnetic Resonance Imaging (MRI) unlike X-rays and CT-scans does not use radiation to
create a picture. MRI use as the name implies, magnetism to create pictures with
excellent anatomical resolution. Functional MRIs are diagnostic tests that allow doctors
to not only view anatomy, but physiology and function. It is for these reasons that MRIs
are excellent methods for studying the brain.
In this study, researchers will use MRI to assess brain anatomy and function in X and Y
chromosome variation, healthy volunteers, and patients with a variety of childhood onset
psychiatric disorders. The disorders include attention deficit disorder, autism,
congenital adrenal hyperplasia, childhood-onset schizophrenia, dyslexia, obsessive
compulsive disorder, Sydenham's chorea, and Tourette's syndrome.
Results of the MRIs showing the anatomy of the brain and brain function will be compared
across age, sex (gender), and diagnostic groups. Correlations between brain and
behavioral measures will be examined for normal and clinical populations....
Type: Observational
Start Date: Jun 1990
open study
|
|
[18F]PF-06445974 to Image PDE4B in Major Depressive Disorder Using PET
National Institute of Mental Health (NIMH)
Depression
Background:
Major depressive disorder (MDD) is a psychiatric condition. People with MDD have
occasional bouts of depressive symptoms; these bouts are called major depressive episodes
(MDEs). Researchers want to know if people having MDEs have lower levels of an enzyme
called PDE4B in their brains.1 expand
Background:
Major depressive disorder (MDD) is a psychiatric condition. People with MDD have
occasional bouts of depressive symptoms; these bouts are called major depressive episodes
(MDEs). Researchers want to know if people having MDEs have lower levels of an enzyme
called PDE4B in their brains.
Primary Objective: To determine whether PDE4B is reduced in the brains of individuals
with MDD experiencing a major depressive episode (MDE). Secondary Objectives: To
determine the optimal length of scanning and the retest variability and reliability of
[18F]PF-06445974, and whether PDE4B binding correlates with clinical rating scales. To
measure if PDE4B radioligand binding can be blocked by taking apremilast.
Eligibility:
People aged 18-70 years with MDD. Healthy volunteers are also needed.
Design:
Participants will have up to 5 clinic visits.
Participants will be screened. They will have a physical exam with blood tests. They will
have a test of their heart function. Some participants may have a psychiatric assessment;
they will answer questions about their state of mind and related topics.
Participants will have magnetic resonance imaging (MRI) of the brain. They will lie on a
table that slides into a metal cylinder.
Participants will have a positron emission tomography (PET) scan. A needle will be used
to guide a thin plastic tube (catheter) into a vein in one arm. An experimental substance
called a radioactive tracer ([18F]PF-06445974) will be injected through the catheter.
Participants will lie on a table that slides into a doughnut-shaped machine. The scan
will last up to 4 hours with a 15-minute break.
Participants blood pressure, heart rate, and breathing will be monitored before, during,
and after the PET scan. A second catheter will be inserted in the artery of the wrist so
blood can be drawn during the scan.
Some participants may return for a second PET scan; have a lung scan or receive
apremilast.
https://nimhcontent.nimh.nih.gov/start/surveys/?s=KE88DXXPLDFHHTF8
Type: Interventional
Start Date: Jun 2023
open study
|
|
Functional Magnetic Resonance Imaging Sleep Study With Auditory Stimuli
National Institute of Neurological Disorders and Stroke (NINDS)
Normal Physiology
Background:
An electroencephalogram (EEG) measures the brain s electrical activity. EEG shows that
the louder the sound needed to wake a person, the deeper the person s sleep. Researchers
are using functional magnetic resonance imaging (fMRI) to study people during sleep so
they can view brain act1 expand
Background:
An electroencephalogram (EEG) measures the brain s electrical activity. EEG shows that
the louder the sound needed to wake a person, the deeper the person s sleep. Researchers
are using functional magnetic resonance imaging (fMRI) to study people during sleep so
they can view brain activity in 3D. But they still need to correlate fMRI with sound
thresholds, like the EEG.
Objective:
To measure brain activity during sleep using fMRI and EEG.
Eligibility:
Healthy people ages 18 34 who can sleep on their back for several hours.
Design:
Participants will be screened online about their sleep and general health.
At a screening visit, participants will have:
Physical exam
Hearing exam
MRI scan. A strong magnetic field and radio waves take pictures of the brain.
Participants will lie down on a bed that slides into the scanner, which is shaped like a
cylinder.
Participants will wear an actigraph on their wrist that records their motor activity.
Participants will follow a 2-week routine. This includes regular in-to-bed and out-of-bed
times and limits on alcohol, caffeine, and nicotine.
During the overnight visits, participants will have:
Female subjects will have a urine pregnancy test.
fMRI. A coil will be placed over the head. Participants will do tasks shown on a computer
screen inside the scanner.
EEG. Small electrodes on the scalp will record brain waves while sleeping or doing a task
in the scanner.
Participants will be asked to try to sleep while researchers collect fMRI and EEG data.
Participants eyes will be monitored with a video camera. Headphones will deliver sounds
to wake them up throughout the night.
...
Type: Observational
Start Date: Jan 2016
open study
|