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Cross-Sectional Evaluation of Persistence of SARS-CoV-2 Remnants After Recovery From Acute Infection
National Institute of Neurological Disorders and Stroke (NINDS)
PASC Post Acute Sequelae of COVID-19
Background:
SARS-CoV-2 is the virus that causes COVID-19. Some people who recover from COVID-19 have
symptoms that last long after the active infection ends. This is called long COVID.
Sometimes, long COVID can affect the nerves and cause problems with sleep, thinking, the
senses, and movement. Re1 expand
Background:
SARS-CoV-2 is the virus that causes COVID-19. Some people who recover from COVID-19 have
symptoms that last long after the active infection ends. This is called long COVID.
Sometimes, long COVID can affect the nerves and cause problems with sleep, thinking, the
senses, and movement. Researchers want to find out whether people with long COVID have
retained inactive remnants of SARS-CoV-2 in their bodies.
Objective:
To collect tissue samples to see if people with long COVID have remnants of SARS-CoV-2 in
their bodies.
Eligibility:
People 18 years or older who have recovered from COVID-19, both with and without
neurologic symptoms.
Design:
Participants will have 2 to 4 inpatient or outpatient visits over 4 months. Each visit
will last 4 to 5 days.
Participants will be screened to make sure it is safe to collect tissue samples from
their body. They will have a physical and dental exam. They will have imaging scans and a
test of their heart function. They will complete questionnaires about their health. They
will give blood, urine, saliva, and stool samples. Their sense of taste and smell will be
tested.
Tissue samples will be taken from the digestive tract, lungs, colon, skin, muscle, lymph
nodes, nasal passages, and mouth. Participants may be numbed or sedated for some of the
procedures.
Swabs will be used to collect cells from inside the mouth and nose.
Participants will undergo lumbar puncture. A thin needle will be inserted into their
lower back to draw out a sample of the fluid around their spinal cord.
Participants will have follow-up phone calls after each clinic visit.
Type: Observational
Start Date: Mar 2025
open study
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Connect for Cancer Prevention Study (Connect)
National Cancer Institute (NCI)
Cancer
General Research Use
Background:
The National Cancer Institute, part of the National Institutes of Health, has partnered
with nine health care systems across the U.S. to establish the Connect for Cancer
Prevention Study. While researchers have made important discoveries, there is more to
learn to lower the number of p1 expand
Background:
The National Cancer Institute, part of the National Institutes of Health, has partnered
with nine health care systems across the U.S. to establish the Connect for Cancer
Prevention Study. While researchers have made important discoveries, there is more to
learn to lower the number of people affected by cancer. By taking part in Connect,
participants can help researchers learn how the way we live, our genetics, and our health
history may affect cancer risk.
Objective:
To study and better understand the causes of cancer and to find new ways to prevent it.
Eligibility:
The study will include 200,000 adults who get their health care from a partner health
care system, are between 30 and 70 years old at enrollment, and have never had cancer.
People remain eligible to join if they have or once had non-melanoma skin cancer, or a
condition that may raise cancer risk (such as ductal carcinoma in situ, or DCIS).
Design:
Eligible recruits can sign up for Connect online by creating an account on MyConnect
using their email address or phone number. After creating an account, they will complete
the informed consent process. All information shared through MyConnect is secure to
protect participant privacy. After joining the study, participants will be asked to
answer online health surveys a few times a year, donate samples of blood, urine, and
saliva every two to three years, and safely share access to their electronic health
records with Connect. In the future, participants may donate unused samples that are
collected at clinical visits, like tissue, stool, or blood, and may mail in samples
collected at home. Participants may also share information from personal health trackers,
like wearable devices or apps.
This information will help researchers study the health and behavior patterns that may
affect cancer risk.
It takes time to understand the causes of cancer, so Connect will go on for many years.
The longer people participate, the more researchers may learn. Participants can leave the
study at any time.
Learn more about Connect by visiting cancer.gov/connectstudy.
Type: Observational
Start Date: Jul 2021
open study
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Allogeneic Hematopoietic Stem Cell Transplant for Patients With Inborn Errors of Immunity
National Cancer Institute (NCI)
Lymphoproliferative Disorders
Autoimmune Lymphoproliferative
Immune System Diseases
Common Variable Immunodeficiency
Primary T-cell Immunodeficiency Disorders
Background:
During a transplant, blood stem cells from one person are given to someone else. The
cells grow into the different cells that make up the immune system. This can cure people
with certain immunodeficiencies. But transplant has many risks and complications.
Objective:
To see if stem ce1 expand
Background:
During a transplant, blood stem cells from one person are given to someone else. The
cells grow into the different cells that make up the immune system. This can cure people
with certain immunodeficiencies. But transplant has many risks and complications.
Objective:
To see if stem cell transplant can be successfully performed in people with primary
immunodeficiency disease and cure them.
Eligibility:
People ages 4-69 for whom a primary immunodeficiency (PID) or Primary Immune Regulatory
Disorder (PIRD), has caused significant health problems and either standard management
has not worked or there are no standard management options, along with their donors
Design:
Donors will be screened under protocol 01-C-0129. They will donate blood or bone marrow.
Participants will be screened with:
Medical history
Physical exam
Blood, urine, and heart tests
CT or PET scans
Before transplant, participants will have dental and eye exams. They will have a bone
marrow biopsy. For this, a needle will be inserted through the skin into the pelvis to
remove marrow.
Participants will be hospitalized before their transplant. They will have a central
catheter put into a vein in their chest or neck. They will get medications through the
catheter to prevent complications. Participants will get stem cells through the catheter.
They will stay in the hospital for at least 4 weeks. They will give blood, urine, bone
marrow, and stool samples. They may need blood transfusions. They may need more scans.
They will take more medications.
Participants will have visits on days 30, 60, 100, 180, and 360, and 24 months after the
transplant. Then they will have visits once a year for about 5 years
Type: Interventional
Start Date: Sep 2020
open study
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Genomic Services Research Program
National Human Genome Research Institute (NHGRI)
Colon Cancer
Breast Cancer
Background:
Genes are the instructions a person s body uses to function. Genome sequencing is a new
way to look at genes that your main research team is using to learn the causes of the
condition they are studying. When a new cause is found this way, it is called a primary
variant. Each person has1 expand
Background:
Genes are the instructions a person s body uses to function. Genome sequencing is a new
way to look at genes that your main research team is using to learn the causes of the
condition they are studying. When a new cause is found this way, it is called a primary
variant. Each person has many variants. Most do not cause disease. Sequencing can also
find secondary variants. These are not related to the condition your main research team
is studying, but may show a person to be at high risk for cancer or another condition.
Researchers want to learn more about what it means to have a secondary variant.
Objectives:
To find new gene changes that lead to certain medical conditions. To better understand
the causes of certain diseases. To learn about how people understand their genetic test
results.
Eligibility:
People with rare diseases who have already consented to and enrolled in another protocol
run by a group other than the National Human Genome Research Institute.
Design:
DNA samples that were already collected will be studied.
Participants may be asked to send in a second DNA sample (blood or saliva). These will be
used to verify any findings.
If a primary variant for the participant s health condition is found through genome
sequencing, this will be shared with the participant by their primary research team.
If the participant has a secondary finding, it will be shared by phone call or
videoconference by this research group in the National Human Genome Research Institute.
Some participants may get their results in person at the clinic.
Three months after getting their secondary findings, participants will do an online
survey and phone interview. They will be asked about how they have used the information.
Some people who do not receive a secondary finding from genome sequencing will be asked
to do an online survey three months after they get that result.
Participants who have a secondary finding can get genetic counseling.
Type: Observational
Start Date: Sep 2014
open study
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Diabetes and Heart Disease Risk in Blacks
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Cardiovascular Diseases
Diabetes
Obesity
Hypertension
It is unknown if obesity contributes to the development of heart disease in African
American men and women.
This study was created to determine whether there is a relationship between sex and body
size and the incidence of heart disease in African American men and women. Researchers
will attempt t1 expand
It is unknown if obesity contributes to the development of heart disease in African
American men and women.
This study was created to determine whether there is a relationship between sex and body
size and the incidence of heart disease in African American men and women. Researchers
will attempt to associate obesity with the presence of heart disease risk factors. Risk
factors that will be studied include; total body fat, body fat distribution, fat content
of the blood (triglyceride concentration, low density lipoproteins [LDL], and high
density lipoproteins [HDL]), how fast fat is removed from the blood, and how well insulin
works in the body.
Scientific studies have shown that obesity and increased levels of fat content in the
blood are important risk factors for heart disease in Caucasian women. However, similar
studies in African American women have failed to show the same correlation. In fact, it
appears that African American women in all three body weight groupings, nonobese,
overweight, and obese experience high death rates due to heart disease. In addition,
prior research has shown that obese African American men tend to have elevated levels of
fat in the blood while African American women have normal blood fat levels. Therefore, if
high levels of triglycerides (fat found in the blood) are not seen in non-diabetic obese
African American women, it cannot be considered a risk factor in this population. This
suggests that studies conducted on Caucasian women may not provide insight into heart
disease risk factors in African American women.
The study will take 2000 healthy non-diabetic African American men and women (ages 18-70)
and body mass index 3 subgroups; nonobese, overweight and obese. Diabetes undeniably
increases the risk of heart disease. Therefore patients suffering from diabetes will not
be included in the study. Candidates for the study will undergo a series of tests and
examinations over 2 outpatient visits. Subjects will have body fat analyses, resting
energy expenditure measurements, an EKG (electrocardiogram), and specific blood tests.
Researchers believe this study will provide significant insight into the causes of
obesity and heart disease in African Americans....
Type: Observational
Start Date: Oct 1998
open study
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Diet Order Effects of Low Fat vs. Low Carb Diets on Body Fat Change
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Overweight
Obesity
Background:
In a previous study, participants were lived at the NIH and randomly received either a
low-fat or a low-carbohydrate diet for 2 weeks and then switched to the other diet for 2
more weeks. Participants who received the low-carbohydrate diet first lost more body fat
at the end of the stu1 expand
Background:
In a previous study, participants were lived at the NIH and randomly received either a
low-fat or a low-carbohydrate diet for 2 weeks and then switched to the other diet for 2
more weeks. Participants who received the low-carbohydrate diet first lost more body fat
at the end of the study than those who received the low-fat diet first. Researchers want
to see if they can repeat that result in a longer weight loss study when participants
live at home.
Objective:
To test the effects of diet order in people receiving either a low-fat or
low-carbohydrate diet first for 4 weeks and then immediately switched to the other diet
for another 4 weeks.
Eligibility:
Adults aged 19 to 50 years with a body mass index of 25 or more.
Design:
Participants will complete the study at their homes, but there will be 3 required visits
to the NIH. Participants will drink a special type of water 2 weeks before the baseline
NIH visit and collect urine samples at home to measure how many calories they burn.
Before the diets begin, participants will visit the NIH for baseline testing when they
will have a metabolism test while relaxing in a bed with a plastic hood over their head
to collect the air they breathe out. They will have scans to measure their bone density
and how much muscle and body fat they have. They will give stool, blood, and urine
samples.
Participants will be asked to eat a specific diet for 4 weeks followed by a different
diet for 4 weeks. All meals will be delivered to the participants homes. They will eat
only the foods delivered.
Participants will weigh themselves daily. They will wear a monitor to track their
physical activity and a sensor to measure their glucose levels. They will prick their
finger each morning to test a drop of blood for ketones. Participants will meet virtually
as a group with the study team weekly. Participants will have two more NIH visits towards
the end of each diet period....
Type: Interventional
Start Date: Aug 2024
open study
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Study of Alkaptonuria
National Human Genome Research Institute (NHGRI)
Alkaptonuria
The purpose of this study is to gain a better understanding of alkaptonuria and collect
medical data on patients who may later participate in new drug trials for this rare
genetic disease. In alkaptonuria, a pigment called homogentisic acid collects in bone and
connective tissue, causing arthritis1 expand
The purpose of this study is to gain a better understanding of alkaptonuria and collect
medical data on patients who may later participate in new drug trials for this rare
genetic disease. In alkaptonuria, a pigment called homogentisic acid collects in bone and
connective tissue, causing arthritis and eventually bone fractures, and also causes
discoloration in the ears and whites of the eyes. Some patients also develop kidney
stones and heart valve problems. Alkaptonuria has not been studied for decades; and
scientists expect to gain comprehensive clinical information using current medical
techniques.
Patients with alkaptonuria who are at least two years of age may be eligible for this
study. Participants will be evaluated at NIH s Clinical Center for 3 to 5 days every 2 to
3 years. They will have a medical history, physical examination, routine blood and urine
tests. Blood may also be collected to measure a type of collagen that indicates new bone
formation and to analyze DNA for genetic studies. 24-hour urine collections will be done
to measure organic acids and homogentisic acid excretion, assess overall kidney function,
and evaluate bone metabolism. A total of 89.5 ml (about 6 tablespoons) of blood will be
drawn for these studies in adults and 51 ml (about 3 tablespoons) in children.
Patients will (may) also have bone X-rays, kidney ultrasound, brain and chest
computerized tomography (CT) scans, magnetic resonance imaging (MRI) scans of affected
joints, electrocardiograms, echocardiogram, lung function tests, and a hearing test.
Photographs of the face and full body (with underwear on) will be taken.
As medically indicated, patients will also have consultations with dentistry and
ophthalmology, with physical therapy and rehabilitation medicine for arthritis
management, and with cardiology for heart valve evaluation. When appropriate, patients
may also have dermatology, pulmonology and neurology consultations.
The information from this study will enable doctors to better advise patients with
alkaptonuria about their disease and treatment options. It will also prepare the way for
clinical studies of a new drug that blocks production of homogentisic acid.
Type: Observational
Start Date: Jun 2000
open study
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Induced Blood-Stage Malaria in Healthy Malaria-Naive Adults to Assess the Safety and Infectivity of1
National Institute of Allergy and Infectious Diseases (NIAID)
Malaria
Background:
Malaria is a disease caused by parasites transmitted to people by mosquitoes. Around the
world, there were 241 million cases and 627,000 deaths from malaria in 2020. Researchers
are working to develop vaccines and treatments for this disease.
Objective:
To learn how malaria develops1 expand
Background:
Malaria is a disease caused by parasites transmitted to people by mosquitoes. Around the
world, there were 241 million cases and 627,000 deaths from malaria in 2020. Researchers
are working to develop vaccines and treatments for this disease.
Objective:
To learn how malaria develops in people; how the body's immune system reacts to malaria;
and how malaria spreads from people to mosquitoes.
Eligibility:
Healthy people in the Washington DC area, aged 18 to 54 years. They cannot live alone
during parts of the study.
Design:
Participants will be infected with a parasite that causes malaria. The parasite will be
in donated blood; it will be given through an IV.
Participants will likely develop symptoms within a week after the injection. Researchers
will call daily to check on their health. After about 6 days, participants will come to
the NIH clinic each day for blood tests.
Participants will check in to the NIH clinic around 10 days after the injection. They
will stay in the clinic 3 to 6 days. They will have multiple blood tests every day.
Participants will be bitten by mosquitoes up to 4 times. Cups containing mosquitoes will
be held against their skin for 15 minutes.
Participants will begin taking chloroquine close to the end of their clinic stay.
Chloroquine is a pill taken by mouth once or twice a day for 3 days. It is FDA-approved
to treat malaria.
Participants will have follow-up visits 1 and 3 weeks after discharge....
Type: Interventional
Start Date: Nov 2024
open study
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Hippocampal Network Changes Following Mindfulness Training in Tobacco Vaping Adolescents in an Open1
National Institute on Drug Abuse (NIDA)
Vaping Teens
Healthy Volunteers
The purpose of this translational bench-to-bedside study is to examine the
neurobiological effects of an evidence-based technology-delivered mindfulness training
(MT) program on vaping-related rsFC alterations in hippocampal networks and testing
whether changes in rsFC ((Delta)rsFC) in these networ1 expand
The purpose of this translational bench-to-bedside study is to examine the
neurobiological effects of an evidence-based technology-delivered mindfulness training
(MT) program on vaping-related rsFC alterations in hippocampal networks and testing
whether changes in rsFC ((Delta)rsFC) in these networks predict reduction in tobacco
vaping behaviors in adolescents. The study also aims to test the accessibility and
feasibility of using this mindfulness-based stress reduction (MBSR) platform as an
implementation for widespread MT in adolescents....
Type: Interventional
Start Date: May 2025
open study
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Effect of Ultra-processed Versus Unprocessed Diets on Energy Metabolism
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Healthy Diet
Obesity
Protocol Number: 22DK0002
Title: Effects of Ultra-processed versus Unprocessed Diets on Energy Metabolism
Background:
Many diets worldwide include both processed and unprocessed foods. Researchers want to
study the effects these foods have on a person s health.
Objective:
To study how differen1 expand
Protocol Number: 22DK0002
Title: Effects of Ultra-processed versus Unprocessed Diets on Energy Metabolism
Background:
Many diets worldwide include both processed and unprocessed foods. Researchers want to
study the effects these foods have on a person s health.
Objective:
To study how different diets affect a person s health and metabolism.
Eligibility:
Adults aged 18 60 without diabetes who have stable weight and can exercise.
Design:
Participants will be screened with:
Medical history
Physical exam
Heart tests
Resting energy expenditure (to determine calorie needs)
Blood and urine tests
20-minute stationary bicycle session
Food, diet, and mental health questionnaires
Participants will stay at NIH for 4 weeks. They will receive 3 meals a day and may eat as
little or as much as they want. The diet will change each week. Their weight will be
recorded daily. They will ride a stationary bicycle daily. Each week, they will do the
following:
Spend 1 day in a special room that assesses their metabolism
Have 24-hour urine collections
Give skin and fecal samples
Repeat some screening tests
Have scans to measure body fat
Complete computerized behavior tasks
Wear an activity monitor to track physical activity
Wear a glucose monitor. A sensor will be inserted under the skin with a small needle. It
will be replaced weekly.
Take taste tests. They will swish water and flavored liquids around in their mouth and
pick which ones had a non-neutral taste. They will also compare liquids for which ones
taste better.
Participation will last for 4 weeks.
Sponsoring Institution: National Institute of Diabetes and Digestive and Kidney Diseases
...
Type: Interventional
Start Date: Nov 2022
open study
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Natural History Study of the KSHV Inflammatory Cytokine Syndrome (KICS)
National Cancer Institute (NCI)
KSHV Inflammatory Cytokine Syndrome (KICS)
KSHV
HHV-8
Background:
- KSHV inflammatory cytokine syndrome (KICS) is a newly recognized disease caused by
Kaposi sarcoma-associated herpesvirus (KSHV). This virus can cause cancer. People
with KICS can have severe symptoms. They include fever, weight loss, and fluid in
the legs or abdomen1 expand
Background:
- KSHV inflammatory cytokine syndrome (KICS) is a newly recognized disease caused by
Kaposi sarcoma-associated herpesvirus (KSHV). This virus can cause cancer. People
with KICS can have severe symptoms. They include fever, weight loss, and fluid in
the legs or abdomen. People with KICS may also be at risk of getting other cancers
associated with KSHV. These cancers include Kaposi sarcoma and lymphoma. Because
KICS is a newly identified disease, more information is needed on how the disease
works and what can be done to treat it.
Objectives:
- To collect genetic and medical information from people with KSHV inflammatory
cytokine syndrome.
Eligibility:
- Individuals at least 18 years of age who have Kaposi sarcoma herpes virus and
symptoms that resemble those caused by KICS.
Design:
- Participants will have regular study visits. The schedule will be determined by the
study researchers.
- Participants will provide a complete medical history and have a full physical exam.
Blood and urine samples will be collected as well.
- People with KICS that requires treatment may get new experimental treatments. These
treatments may include antiviral drugs and chemotherapy drugs, depending on the
nature of the disease.
- Participants will have imaging studies, such as chest x-rays and computed tomography
scans, to study the tumors.
- Bone marrow and lymph node biopsies may be done to collect tissue samples for study.
- Participants who have Kaposi sarcoma will have photographs taken of their lesions.
Type: Interventional
Start Date: Sep 2011
open study
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Genetic and Epigenetic Signatures of Translational Aging Laboratory Testing (GESTALT)
National Institute on Aging (NIA)
Healthy Volunteers
Non-Healthy/Non-Frail
Frail
Background:
- Biomarkers are substances in people s blood and tissues. They help researchers
understand diseases and signs of aging. Scientists want to do more research on
biomarkers to find ways to improve quality of life in old age.
Objective:
- To learn more about biomarkers a1 expand
Background:
- Biomarkers are substances in people s blood and tissues. They help researchers
understand diseases and signs of aging. Scientists want to do more research on
biomarkers to find ways to improve quality of life in old age.
Objective:
- To learn more about biomarkers and their relationship to aging.
Eligibility:
- Adults at least 20 years old who weigh at least 110 pounds and have a body mass
index below 30. They must agree that their genetic samples can be collected,
studied, and stored.
Design:
- Participants will be screened with medical history, physical exam, and blood and
urine tests. They will have heart tests and nurse will assess their veins. They will
fill out a questionnaire.
- Participants will have a 2-day baseline visit. Then they will return every 2 years
for up to 10 years. These follow-up visits will repeat the baseline visit:
- Repeat of screening procedures.
- Physical performance tests like balance and walking tests.
- Leg and grip strength tests.
- Health and mental state questions.
- Memory and problem solving tests.
- Cytapheresis. Blood will be removed through a needle in the vein of one arm and run
through a machine. The blood will be returned through a needle in a vein of the
other arm.
- Visits may also include:
- Magnetic resonance imaging scans. Participants will lie on a table that slides in
and out of a machine that takes pictures.
- Diabetes test. After fasting, participants will drink a sweet drink and give blood.
- Breathing and walking tests.
- Wearing a device that record physical activity.
- Scan of the abdomen and the right leg.
- A small amount of muscle tissue and/or skin removed.
Type: Observational
Start Date: Mar 2015
open study
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Improved Methods of Cell Selection for Bone Marrow Transplant Alternatives
National Heart, Lung, and Blood Institute (NHLBI)
Graft-Versus-Host Disease
Graft-versus-leukemia
Donor Apheresis
Bone marrow transplants (BMT) are one form of treatment for disorders of the blood,
including leukemia. However, because the procedure is often associated with potentially
life-threatening reactions, it is usually reserved for patients with serious illnesses
under the age of 60 years old.
One seri1 expand
Bone marrow transplants (BMT) are one form of treatment for disorders of the blood,
including leukemia. However, because the procedure is often associated with potentially
life-threatening reactions, it is usually reserved for patients with serious illnesses
under the age of 60 years old.
One serious reaction complicating bone marrow transplants is referred to as
graft-versus-host disease (GVHD). GVHD is a potentially fatal incompatibility reaction.
The reaction is caused by antigens found on the cells of the patient that are not present
on the cells of the donor. The antigens are recognized by transplanted white blood cells
(lymphocytes). These lymphocytes begin attacking the recipient s cells and tissues and
may lead to death.
In order to avoid GVHD, researchers have developed a technique using peripheral blood
instead of bone marrow that allows transplantation of stem cells and removal of
lymphocytes. Stem cells are the cells responsible for returning blood cell production to
normal. Lymphocytes are the white blood cells that can cause GVHD.
The technique requires two steps. In the first step blood cells are collected from donors
who have received doses of a growth factor. The growth factor (granulocyte colony
stimulating factor) is designed to increase the production of donor stem cells.
In the second step white blood cell lymphocytes are removed from the collected blood,
leaving only the stem cells.
The main goal of this study is to develop and improve the method of processing cells that
are collected after stimulation with growth factor (G-CSF), by removing the white blood
cell lymphocytes which can cause graft-versus-host disease (GVHD) while keeping the stem
cells necessary for healthy blood cell building. In addition, researchers are interested
in studying whether giving G-CSF has an effect on lymphocyte function, which may
influence the immune reactions occurring in bone marrow transplantation.
Type: Observational
Start Date: Mar 1996
open study
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Dupilumab as Add-On Therapy for Hypereosinophilic Syndrome With Partial Clinical Response to Eosino1
National Institute of Allergy and Infectious Diseases (NIAID)
Hypereosinophilic Syndrome
Background:
Hypereosinophilic syndrome (HES) is a blood disorder that causes high levels of white
blood cells called eosinophils. HES can damage the lungs and airways, intestines, skin,
and other organs. The current primary treatment for HES can cause serious side effects.
Secondary treatments do1 expand
Background:
Hypereosinophilic syndrome (HES) is a blood disorder that causes high levels of white
blood cells called eosinophils. HES can damage the lungs and airways, intestines, skin,
and other organs. The current primary treatment for HES can cause serious side effects.
Secondary treatments do not work in all people.
Objective:
To test an approved drug (dupilumab), combined with other drugs, in people with HES.
Eligibility:
People aged 18 years and older who take drugs (mepolizumab, reslizumab, or benralizumab)
to treat HES.
Design:
Participants will have up to 6 clinic visits and 7 remote visits in up to 48 weeks.
Participants will be screened. They will have blood and urine tests. They will have a
test of their heart function. They will take surveys about how HES affects their daily
life. Some participants may have a bone marrow biopsy: A sample of tissue and fluid from
inside a bone will be removed with a large needle.
Participants will have other tests specific to their symptoms. For example, those with
symptoms affecting their lungs will have breathing tests. Others may have tests that
target symptoms in their sinuses, gastrointestinal tract, or skin.
Dupilumab is injected under the skin once every 1 or 2 weeks. Dose and timing will vary
among participants. They will be taught how to inject themselves at home between clinic
visits. They will take dupilumab plus their current medications for 24 weeks. If the drug
is helping them, they will continue taking it for another 24 weeks.
Participants will have a final visit 12 weeks after their last dose.
Type: Interventional
Start Date: Feb 2025
open study
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Surveillance for Malignant Transformation of Neurofibromatosis Type 1 (NF1) Related Peripheral Nerv1
National Cancer Institute (NCI)
Neurofibromatosis 1
Nerve Sheath Neoplasms
Background:
Neurofibromatosis type 1 (NF1) is a genetic disease that can cause many symptoms. About
half of people with NF1 will develop benign (noncancerous) tumors along nerves in the
skin, brain, and other parts of the body. Sometimes, though, these tumors can become
cancerous. Researchers do n1 expand
Background:
Neurofibromatosis type 1 (NF1) is a genetic disease that can cause many symptoms. About
half of people with NF1 will develop benign (noncancerous) tumors along nerves in the
skin, brain, and other parts of the body. Sometimes, though, these tumors can become
cancerous. Researchers do not yet know how to predict which tumors will become cancerous.
Objective:
To test a new method for predicting which benign NF1 tumors will become cancerous.
Eligibility:
People aged 3 years and older with a clinical or genetic diagnosis of NF1.
Design:
- Participants will be screened with a review of their medical history. All
participants will have a baseline visit. They will have bood tests and imaging
scans. They will have a physical exam. They will answer questions about their family
history. Participants aged 8 years and older will take tests of their thinking
skills and their emotional health.
- Some participants may be asked to undergo more tests. These may include another type
of imaging scan and a biopsy: A small sample of tissue may be removed from the
tumor.
- Participants will be divided into two groups: those believed to be at low risk and
those believed to be at high risk of developing cancer.
- Participants in the high-risk group will be asked to return for their next visit in
1 month to 3 years.
- Participants in the low-risk group will be asked to return for their next visit in 6
months to 5 years.
- Participants may also have follow-up visits by phone throughout the study. They will
be in the study for 10 years.
Type: Observational
Start Date: Oct 2024
open study
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Spironolactone in Alcohol Use Disorder (SAUD)
National Institute on Drug Abuse (NIDA)
Alcohol Use Disorder
Background:
Alcohol use disorder (AUD) affects about 29.5 million people in the United States. Only 3
medicines have been approved by Food and Drug Administration to treat AUD. Researchers
want to find better treatments for AUD. Animal studies found that a medicine called
spironolactone, may decre1 expand
Background:
Alcohol use disorder (AUD) affects about 29.5 million people in the United States. Only 3
medicines have been approved by Food and Drug Administration to treat AUD. Researchers
want to find better treatments for AUD. Animal studies found that a medicine called
spironolactone, may decrease the amount of alcohol the animals drank. Spironolactone is
approved to treat high blood pressure, or heart failure in people. It is not approved to
treat AUD.
Objective:
To test a medicine (spironolactone) in people who sometimes drink excessive alcohol in
order to understand how the body breaks down spironolactone and if there are any side
effects in people who drink alcohol while taking this medicine.
Eligibility:
People aged 21 and older with AUD.
Design:
Participants will have 4 separate 7-day stays at a clinic in Baltimore over 2 months.
Spironolactone is a capsule you swallow. Participants will take a capsule twice a day for
5 days during each clinic stay. During 1 of their 4 stays, they will take a placebo
instead of the medicine. The placebo capsule looks just like the spironolactone capsule
but contains no medicine. Participants will not know when they are taking the medicine or
the placebo.
Participants will not drink alcohol until day 6 of each clinic stay. Then they will be
asked to drink alcohol in a bar-like area in the clinic. Their breath and blood alcohol
levels and their well-being will be measured.
Participants will undergo other tests in the clinic:
A DEXA (dual energy X-ray absorptiometry) scan uses X-rays to measure bone density and
muscle mass. Participants will lie on an open-top, padded table, then a small arm will
scan the full length of their body. The radiation participants will get in this study is
about the same as from one regular x-ray.
Blood tests. Participants may feel some discomfort at the site of needle entry.
Electrocardiogram. This test records the heart activity. Sensors are attached to the skin
with stickers and removed after a few minutes.
Urine tests. All urine will be collected over a 3-day period during each stay. We will
measure the amount of urine, and different hormones and salts in the urine.
Questionnaires and tasks. Participants will answer questions about their alcohol use.
They will perform tasks to test mood, craving, mental and physical coordination, and how
much they feel an effect from alcohol after drinking.
Type: Interventional
Start Date: Jul 2023
open study
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Bevacizumab in Adults With Recurrent Respiratory Papillomatosis (RRP)
National Cancer Institute (NCI)
Respiratory Tract Diseases
Neoplasms
Neoplasms by Histologic Type
Neoplasms, Glandular and Epithelial
Neoplasms, Squamous Cell
Background:
Recurrent respiratory papillomatosis (RRP) is a rare disease that causes wart-like
growths in the airways. These growths come back when removed; some people may need 2 or
more surgeries per year to keep their airways clear. Better treatments are needed.
Objective:
To see if a drug ca1 expand
Background:
Recurrent respiratory papillomatosis (RRP) is a rare disease that causes wart-like
growths in the airways. These growths come back when removed; some people may need 2 or
more surgeries per year to keep their airways clear. Better treatments are needed.
Objective:
To see if a drug called bevacizumab can reduce the number of surgeries needed in people
with RRP.
Eligibility:
People aged 18 and older with recurrent RRP; they must need surgery to remove the growths
in their airways.
Design:
Participants will be screened. Their ability to breathe and speak will be evaluated. They
will have an endoscopy: a flexible tube with a light and camera will be inserted into
their nose and throat. They will have a test of their heart function and imaging scans of
their chest.
Participants will have surgery to remove the growths in their airways.
Bevacizumab is given through a small tube placed in a vein in the arm. After the surgery,
participants will receive 11 doses of this drug: every 3 weeks for 3 doses, and then
every 6 weeks for 8 more doses. They will come to the clinic for each dose; each visit
will be about 8 hours.
Tissue samples of the growths will be collected after the second treatment; this will be
done under general anesthesia.
Participants may undergo apheresis: Blood will be drawn from a needle in an arm. The
blood will pass through a machine that separates out the cells needed for the study. The
remaining blood will be returned to the body through a second needle.
Follow-up will continue for 1 year after the last treatment.
Type: Interventional
Start Date: Aug 2023
open study
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Surgery in Gastrointestinal Stromal Tumors (GISTs) for Treatment, Tumor Modeling, and Genomic Analy1
National Cancer Institute (NCI)
Gastric Cancer
Gastric Neoplasm
Gastrointestinal Stromal Sarcoma
Gastrointestinal Stromal Neoplasm
Gastrointestinal Stromal Tumor (GIST)
Objective:
To follow people with GISTs and collect tumor tissue so that it can be studied in the
lab.
Eligibility:
People age 6 and older who have a GIST.
Design:
Participants will be screened with a review of their medical records and samples.
Participants will enroll in 1 other NIH study, a1 expand
Objective:
To follow people with GISTs and collect tumor tissue so that it can be studied in the
lab.
Eligibility:
People age 6 and older who have a GIST.
Design:
Participants will be screened with a review of their medical records and samples.
Participants will enroll in 1 other NIH study, and may be asked to enroll in 2 other
optional NIH studies.
Participants will have a medical history and physical exam. Data about how they function
in their daily activities will be obtained.
Participants may speak with a genetic counselor. They may have genetic testing.
Participants will give blood samples. They may have a cheek swab. For this, small brush
will be rubbed against the inside of the cheek.
Participants may have a computed tomography (CT) scan of the chest, abdomen, and pelvis.
Or they may have a CT scan of the chest and magnetic resonance imaging (MRI) of the
abdomen and pelvis.
Participants will be monitored every 6-12 months at the NIH Clinical Center, for up to 10
years before having surgery. If they need surgery, it will be performed at the NIH. Then,
they will be monitored every 6-12 months, for up to 5 years after surgery.
If a participant has surgery, tumor tissue samples and research specimen will be taken.
If a participant does not need surgery, their participation will end after 10 years. If
they have surgery, the 5-year monitoring period will restart after each surgery.
Type: Observational
Start Date: Dec 2020
open study
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Allogeneic Hematopoietic Cell Transplantation for Peripheral T Cell Lymphoma
National Cancer Institute (NCI)
Peripheral T-cell Lymphomas
Lymphoproliferative Disorders
Immune System Diseases
Background:
Lymphoma is a type of blood cancer. Blood cell transplant can cure some people with
lymphoma. Researchers want to see if they can limit the complications transplant can
cause.
Objective:
To test if a stem cell transplant can cure or control lymphoma. Also to test if new ways
of getti1 expand
Background:
Lymphoma is a type of blood cancer. Blood cell transplant can cure some people with
lymphoma. Researchers want to see if they can limit the complications transplant can
cause.
Objective:
To test if a stem cell transplant can cure or control lymphoma. Also to test if new ways
of getting a recipient ready for a transplant may result in fewer problems and side
effects.
Eligibility:
Recipients: People ages 12 and older with peripheral T cell lymphoma that does not
respond to standard treatments
Donors: Healthy people ages 18 and older whose relative has lymphoma
Design:
Participants will be screened with:
Physical exam
Blood and urine tests
Bone marrow biopsy: A needle inserted into the participant s hip bone will remove marrow.
Donors will also be screened with:
X-rays
Recipients will also be screened with:
Lying in scanners that take pictures of the body
Tumor sample
Donors may donate blood. They will take daily shots for 5 7 days. They will have
apheresis: A machine will take blood from one arm and take out their stem cells. The
blood will be returned into the other arm.
Recipients will be hospitalized at least 2 weeks before transplant. They will get a
catheter: A plastic tube will be inserted into a vein in the neck or upper chest. They
will get antibody therapy or chemotherapy.
Recipients will get the transplant through their catheter.
Recipients will stay in the hospital several weeks after transplant. They will get blood
transfusions. They will take drugs including chemotherapy for about 2 months.
Recipients will have visits 6, 12, 18, 24 months after transplant, then once a year for 5
years.
...
Type: Interventional
Start Date: Apr 2019
open study
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Evaluation of Adults With Endocrine and Metabolic-Related Conditions
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Endocrine Diseases
Background:
There are many endocrine and metabolic-related conditions. Two well-known disorders
include diabetes and thyroid disease. Some of these diseases are caused by a change in
genes. Researchers want to identify the genes involved in these disorders. They hope this
will help them learn more1 expand
Background:
There are many endocrine and metabolic-related conditions. Two well-known disorders
include diabetes and thyroid disease. Some of these diseases are caused by a change in
genes. Researchers want to identify the genes involved in these disorders. They hope this
will help them learn more about these diseases.
Objectives:
To learn more about conditions that affect the hormone-secreting glands (endocrine
glands) in adults. To train doctors to diagnose and treat people with endocrine or
metabolic conditions.
Eligibility:
Adults age 18 years and older with a known or suspected endocrine disorder.
Relatives ages 18 years and older.
Doctors will review all requests and available medical records to determine final
eligibility for the protocol.
Design:
Participants will have a medical history and physical exam.
Most participants will have 1 visit, and may have follow up visits if necessary. They may
have tests, surgery, or other procedures to help diagnose or treat their condition. These
could include:
- Blood, urine, and saliva tests
- Imaging tests. These may include X-ray, ultrasound, or scans.
- Sleep study
- Medical photographs
- Visits with other specialists at NIH
Participants will provide blood, urine, saliva, or tissue samples. Some of these samples
may be stored in the freezer for future studies.
Participants may be asked to participate in genetic testing. They will give a blood or
saliva sample for this.
Type: Observational
Start Date: Jul 2016
open study
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Baltimore Longitudinal Study of Aging
National Institute on Aging (NIA)
Aging
Background:
- The Baltimore Longitudinal Study of Aging (BLSA) is a clinical research program on
human aging that began in 1958. Volunteers of different ages join the study when
they are healthy, and have follow-up visits for life. Visits last for multiple days.
Participants are1 expand
Background:
- The Baltimore Longitudinal Study of Aging (BLSA) is a clinical research program on
human aging that began in 1958. Volunteers of different ages join the study when
they are healthy, and have follow-up visits for life. Visits last for multiple days.
Participants are evaluated for many physical elements as well as for brain function.
Physical tests are given. Information on mood, personality, and social aspects of
life is also collected. This program has contributed more than any other research
project to our understanding of aging.
Objectives:
- To characterize the many aspects of the aging process and learn how people can
successfully adapt to aging.
Eligibility:
- Healthy individuals at least 20 years old.
Design:
- Participants will receive a booklet and video describing the tests they will take.
- During a 3-day visit at the study hospital, participants will take the following
tests:
- Urine will be collected for 24 hours. Blood samples will be taken. A small piece of
muscle tissue may be collected by a needle.
- A medical questionnaire and a physical exam will be given.
- Participants hearts will be tested, including with blood pressure tests and
electronic monitors. They will breathe into a tube to test their lungs.
- Participants will perform several exercises, including treadmill walking.
- Vision, hearing, and taste will be tested.
- Bone and joint X-rays may be taken.
- Imaging tests will be given, such as an MRI.
- Participants will answer questions to test their mental abilities.
- Participants will return for follow-up visits every few years for life. The tests
listed above will be given at every visit.
Type: Observational
Start Date: Feb 2014
open study
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Evaluating the Genetics and Immunology of Periodic Fever, Aphthous Stomatitis, Pharyngitis, and Cer1
National Institute of Allergy and Infectious Diseases (NIAID)
Periodic Fever, Aphthous Stomatitis, Pharyngitis, And Cervical Adenitis (Pfapa)
Obstructive Sleep Apnea
Tonsillitis
Tonsil Disorder
Sleep Disordered Breathing
Background:
Periodic fever, aphthous stomatitis, pharyngitis, and cervical adenitis (PFAPA) is the
most common periodic fever syndrome of childhood. Symptoms can include swelling of the
glands in the throat, mouth ulcers, and tonsillitis. Removal of the tonsils can stop the
periodic flareups. But1 expand
Background:
Periodic fever, aphthous stomatitis, pharyngitis, and cervical adenitis (PFAPA) is the
most common periodic fever syndrome of childhood. Symptoms can include swelling of the
glands in the throat, mouth ulcers, and tonsillitis. Removal of the tonsils can stop the
periodic flareups. But researchers do not know how PFAPA develops. In this natural
history study, researchers will collect specimens and data from people with PFAPA to see
what they might have in common.
Objective:
To collect blood and other specimens from people with PFAPA to learn more about the
illness.
Eligibility:
People aged 1 month or older with symptoms of PFAPA or another tonsil disorder.
Design:
Participants will be screened. Their medical records will be reviewed. Researchers will
ask about a family history of PFAPA.
The following specimens may be collected:
Blood. Blood will be drawn either from a needle inserted into a vein or from a prick in
the finger or heel.
Mucus and cells. A stick with soft padding on the tip may be rubbed inside the nostrils
or mouth.
Stool.
Saliva.
Tissue samples may be taken if participants are having surgery to remove the tonsils or
adenoids. Participants having surgery may also have a nasopharyngeal wash; salt water
will be squirted into the back of the throat and then sucked back out with a syringe.
Most participants will provide specimens only once. They can do this in person at the
clinic; they can also have their local health providers send specimens to the
researchers. Some participants may have optional follow-up visits over 10 years.
Type: Observational
Start Date: May 2023
open study
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Using Fostamatinib to Treat Post-Hematopoietic Stem Cell Transplant Immune-mediated Cytopenias
National Heart, Lung, and Blood Institute (NHLBI)
Immune Mediated Anemia
Immune Mediated Thrombocytopenia
Chronic GVHD
Background:
People who have a blood stem cell transplant can sometimes develop cytopenia. This means
that their levels of one or more types of blood cell, such as the red cells or platelets,
are lower than they should be. This can occur because a person s immune system might
attack these cells aft1 expand
Background:
People who have a blood stem cell transplant can sometimes develop cytopenia. This means
that their levels of one or more types of blood cell, such as the red cells or platelets,
are lower than they should be. This can occur because a person s immune system might
attack these cells after a stem cell transplant. Cytopenia can lead to anemia, severe
bleeding, infections, and other problems. Treatments are needed to help keep blood cell
levels stable after blood stem cell transplant.
Objective:
To test a study drug (fostamatinib) in people who have cytopenia after a blood stem cell
transplant.
Eligibility:
People aged 18 to 75 years who have cytopenia after a blood stem cell transplant.
Design:
Participants will be screened. They will have a physical exam. They will have blood,
urine, and stool tests.
Fostamatinib is an oral tablet taken by mouth. Participants will take the pills 2 times a
day for 12 weeks.
Participants will have a medical assessment every 2 weeks; their vital signs will be
checked, and they will have blood and stool tests. Participants must come to the NIH
clinic for these visits in weeks 4 and 12. Other visits may be done by telephone or
telehealth; the blood and stool tests can be sent to the researchers from a local lab.
After 4 weeks, some participants may begin taking a higher dose of the drug.
Participants will return for a final medical assessment 2 weeks after they finish taking
the drug.
Participants who complete this study and show evidence that fostamatinib has increased
their blood cell counts may enroll in an extension study to continue taking fostamatinib.
Type: Interventional
Start Date: Mar 2023
open study
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Inflammatory and Infectious Diseases of the Nervous System
National Institute of Neurological Disorders and Stroke (NINDS)
Brain Disease
Background:
- Inflammation is how the body reacts to infection or injury. Infections or
inflammation in the brain and nerves can be serious. There aren t always good tests
to detect this. Researchers want to learn more about how diseases affect the brain
and nerves to develop bet1 expand
Background:
- Inflammation is how the body reacts to infection or injury. Infections or
inflammation in the brain and nerves can be serious. There aren t always good tests
to detect this. Researchers want to learn more about how diseases affect the brain
and nerves to develop better tests and treatments.
Objective:
- To learn more about how inflammation and infections hurt the brain and nervous
system.
Eligibility:
- People at least 2 years old with a diagnosis or suspected diagnosis of nervous
system infection or inflammation.
Design:
- For some participants, a clinician outside of NIH will collect blood, tissue, and
other samples. These will be sent to NIH and analyzed.
- Other participants will have several visits to NIH. Children may not have all these
tests.
- Participants will have:
- Medical history.
- Physical and neurological exam.
- Blood and urine samples collected.
- Saliva collected. They will chew on a piece of sterile cotton for one minute.
- Magnetic resonance imaging (MRI) scan. The scanner is a metal cylinder in a strong
magnetic field. Participants will lie on a table that slides in and out of the
cylinder. Participants will get a contrast agent through an intravenous (IV)
catheter during the MRI. A needle will be used to guide a thin plastic tube
(catheter) into an arm vein.
- Lumbar puncture. Skin will be numbed and a needle will be inserted into the space
between the bones in the back. Fluid will be removed.
- Some participants may have optional study procedures. These may include eye tests,
memory and thinking testing, tests with electrodes on the head, or skin biopsy.
Type: Observational
Start Date: May 2015
open study
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Effects of Dietary Nitrate in Women With Secondary Amenorrhea
Indiana University
Secondary Amenorrhea
Excessive exercise, disordered attitudes toward eating, physical and psychological
stress, and/or hormonal imbalances may result in cessation of menstruation (secondary
amenorrhea). The accompanying lack of estrogen may impair muscle power and oxygen
recovery after exercise by reducing nitric oxide1 expand
Excessive exercise, disordered attitudes toward eating, physical and psychological
stress, and/or hormonal imbalances may result in cessation of menstruation (secondary
amenorrhea). The accompanying lack of estrogen may impair muscle power and oxygen
recovery after exercise by reducing nitric oxide levels. The purpose of this study is to
determine whether ingestion of beetroot juice containing nitrate, an alternative source
of nitric oxide, can help reverse these changes.
Type: Interventional
Start Date: Jul 2025
open study
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