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SMART-r: Substance Monitoring and Active Relapse Tracking Repository
National Institute on Drug Abuse (NIDA)
Alcoholism
Substance-Related Disorders
Background:
About 1.5 million adults in the US enter alcohol or substance use treatment programs each
year. Unfortunately, more than half of patients do not finish their program. For those
who start treatment, about 70% return to substance use within weeks or months after
starting treatment. To di1 expand
Background:
About 1.5 million adults in the US enter alcohol or substance use treatment programs each
year. Unfortunately, more than half of patients do not finish their program. For those
who start treatment, about 70% return to substance use within weeks or months after
starting treatment. To discover why patients drop out of treatment and return to
substance use - and what can be done about it - researchers need to learn more about
people who use drugs and alcohol.
Objective:
To create a data repository by gathering survey and smartphone data from adults who use
drugs and alcohol in order to conduct future research.
Eligibility:
Adults who have used drugs or alcohol in the past and have a Android smartphone. The
researchers will recruit targeted demographics at different times throughout the duration
of the study period.
Design:
Data will be collected for up to 6 months. All research activities will be online.
Participants will download a smartphone app called TTRU-Curtis AWARE and keep it active
on their phone. The app will run in the background and collect participant data,
including: screen unlocks, duration of time the screen is on; apps used; words typed
(except passwords); duration and time of phone calls; estimated location (exact location
is not collected); and movement, such as how many steps are taken in a day. All
personally identifying information is automatically removed before the data is stored
(including phone numbers, names, or locations described in messages).
Each day, participants will receive a text with a link to a survey. They will answer
questions about their mood, behavior, and substance use from the day before. This survey
should take less than 5 minutes to complete.
Every 30 days, participants will complete a longer survey. They will answer questions
about their personal relationships, risky behaviors, mood, substance use, and feelings.
They can skip any questions they do not feel comfortable answering. These surveys should
take about 30 minutes to complete.
Participants may opt to allow researchers to access their social media posts.
Type: Observational
Start Date: May 2026
open study
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Developing Transcranial Neuromodulation Protocols for Learning and Decision-Making
National Institute on Drug Abuse (NIDA)
Normal Physiology
Background:
People with substance use disorder (SUD) often have changes in brain function that can
make it difficult to control drug-seeking behavior. These changes may heighten the urge
to use drugs or lessen the desire to seek nondrug-related rewards. Researchers want to
know how a technique cal1 expand
Background:
People with substance use disorder (SUD) often have changes in brain function that can
make it difficult to control drug-seeking behavior. These changes may heighten the urge
to use drugs or lessen the desire to seek nondrug-related rewards. Researchers want to
know how a technique called transcranial magnetic stimulation (TMS) may cause changes in
brain activity that may help people with SUD.
Objective:
To test TMS in healthy volunteers.
Eligibility:
Healthy people aged 18 to 45 years who are right-handed.
Design:
Participants can volunteer for up to 5 different experiments. Each experiment requires 2
to 8 clinic visits. Each visit will last 3 to 7 hours.
Some visits will include TMS. A coil will be placed on the participant s head. A brief
electrical current will pass through the coil to create a magnetic field. Participants
may feel a tapping or pulling sensation on the skin under the coil. They may feel a
twitch in their face, neck, arm, or leg muscles. Participants may be asked to tense
certain muscles during TMS.
Some visits will include functional magnetic resonance imaging (fMRI) scans. Participants
will lie on a bed that slides into a large tube. They will perform tasks on a computer
inside the tube. The fMRI will show which parts of the brain are used during each task.
Participants will perform tasks on a computer. Some tasks may be done at a desk as well
as during TMS and fMRI. Participants may look at images, listen to sounds, smell odors,
or taste flavored liquids. Their vital signs may be monitored and their eye movements may
be tracked during tasks.
Type: Interventional
Start Date: May 2026
open study
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Natural History and Management of Von Hippel-Lindau (VHL) Associated Pancreatic Neuroendocrine Tumo1
National Cancer Institute (NCI)
VHL Pancreatic Neuroendocrine Tumors
Von Hippel-Lindau Disease
Neuroendocrine Tumors
Background:
People with von Hippel-Lindau (VHL) can have problems with a variety of organs, such as
the pancreas. The disease can cause tumors of the pancreas. This can result in
life-threatening complications. Researchers want to learn more about these pancreatic
tumors and how to better detect t1 expand
Background:
People with von Hippel-Lindau (VHL) can have problems with a variety of organs, such as
the pancreas. The disease can cause tumors of the pancreas. This can result in
life-threatening complications. Researchers want to learn more about these pancreatic
tumors and how to better detect them. This may help them design better future treatment
and care for people with VHL disease.
Objective:
To better understand VHL disease that affects the pancreas and to test whether adding a
certain type of scan (68-Gallium DOTATATE PET/CT) can further detect tumors.
Eligibility:
People ages 12 and older with VHL that causes tumors and cysts to grow in the pancreas
Design:
Participants will be screened with their medical records and imaging studies.
Participants will have an initial evaluation:
Participants will have their body examined by different doctors. This will depend on what
types of symptoms they have.
Participants will have blood and urine tests
Participants will have images made of their body using one or more machines: They made
have a CT or PET/CT scan in which they lie on a table that moves through a big ring. They
may have an MRI in which they lie on a table that moves into a big tube. They may have an
ultrasound that uses a small stick that produces sound waves to look at the body.
After the first visit, participants will be asked to return to the NIH. Some of the tests
performed at the first visit will be repeated. Depending on their disease status, visits
will be once a year or every 2 years for life.
Type: Interventional
Start Date: Jun 2020
open study
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Dietary Omega-7 Palmitoleic Acid-Rich Oil on Lipoprotein Metabolism and Satiety in Adults
National Heart, Lung, and Blood Institute (NHLBI)
Cardiovascular Disease
Background:
Omega-7 fatty acids are found in the oil extracted from certain fish and nuts like
macadamia. Palmitoleic acid is one of the most common omega-7 fatty acids. Many studies
suggest that this oil is good for heart health. Researchers want to find out more about
these potential benefits.1 expand
Background:
Omega-7 fatty acids are found in the oil extracted from certain fish and nuts like
macadamia. Palmitoleic acid is one of the most common omega-7 fatty acids. Many studies
suggest that this oil is good for heart health. Researchers want to find out more about
these potential benefits.
Objective:
To study how oil enriched with palmitoleic acid (Omega-7 oil) affects metabolism.
Eligibility:
Healthy adults at least 18 years old with no known history of cardiovascular disease.
Subjects not allergic to fish oil and fish products
Females that are not pregnant and are not planning a pregnancy during the length of the
study
Design:
Participants will be screened with questions about their health, medical history, and
medicines they take.
Participants will have 4 visits over 24 weeks. The visits may include:
- Blood drawn from a vein in the arm by a needle stick. Sometimes participants will
have to fast before the blood draw.
- Vital signs (blood pressure, heart rate, and temperature) taken
- Body mass index measured
- Cardio-Ankle Vascular Index test may be performed. The stiffness of the participant
s arteries will be measured by reading blood pressure in the arms and legs and
monitoring the heart.
- Optional stool samples
- Pregnancy test
- A short review of participants physical activity and diet
- A supply of dietary supplements to take between visits. Participants will take 4 gel
capsules a day.
Participants will keep a food and exercise journal
Compensation will be provided to subjects that complete the study
Check your eligibility for this study by clicking here:
https://www.surveymonkey.com/r/DietaryOmega
Type: Interventional
Start Date: Jul 2018
open study
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Natural History Study of GATA2 Deficiency and Related Disorders
National Institute of Allergy and Infectious Diseases (NIAID)
GATA2 Deficiency
Background:
- GATA2 deficiency is a genetic disorder that can cause problems with a person s immune
system and other body systems. Some people who have this disorder develop few problems
from it. Others can have a wide range of health problems, from skin problems, to hearing
loss, to cancer. These1 expand
Background:
- GATA2 deficiency is a genetic disorder that can cause problems with a person s immune
system and other body systems. Some people who have this disorder develop few problems
from it. Others can have a wide range of health problems, from skin problems, to hearing
loss, to cancer. These problems can happen at any age. Researchers want to study GATA2
deficiency to better understand what types of health problems it can cause, and why it
causes problems in some people but not others, and at different ages.
Objectives:
- To improve understanding of GATA2 deficiency so there can be better diagnostic tests
and treatments in the future.
Eligibility:
- People 2 years of age or older who have a GATA2 gene mutation or certain health
conditions that are commonly seen in people with this mutation and their blood relatives.
Design:
- Participants will be screened with a physical exam and medical history. Blood and
urine samples will be collected to see whether participants have the GATA2 genetic
mutation. Several other tests may be recommended, but participants can decline to
take them.
- Participants will be eligible to receive standard care for GATA2 deficiency through
this protocol. They may be eligible for other clinical trials at the National
Institutes of Health as well.
- Participants will have regular study visits once a year to evaluate their GATA2
deficiency. Participants will take part in the study for at least 3 years and up to
15 years. At these follow-up visits, participants will fill out a questionnaire and
take a physical exam and blood tests. Other tests may be performed as needed.
Type: Observational
Start Date: Aug 2013
open study
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Hypofractionation Trial of Re-irradiation in Good Prognosis Recurrent Glioblastoma
National Cancer Institute (NCI)
Astrocytoma
Glioma
Recurrent Glioblastoma
Background:
Glioblastoma (GBM) is a cancer of the brain. Current survival rates for people with GBM
are poor; survival ranges from 5.2 months to 39 months. Most tumors come back within
months or years after treatment, and when they do, they are worse: Overall survival drops
to less than 10 months.1 expand
Background:
Glioblastoma (GBM) is a cancer of the brain. Current survival rates for people with GBM
are poor; survival ranges from 5.2 months to 39 months. Most tumors come back within
months or years after treatment, and when they do, they are worse: Overall survival drops
to less than 10 months. No standard treatment exists for people whose GBM has returned
after radiation therapy.
Objective:
To find a safe schedule for using radiation to treat GBM tumors that returned after
initial radiation treatment.
Eligibility:
People aged 18 years and older with grade 4 GBM that returned after initial radiation
treatment.
Design:
Participants will be screened. They will have a physical exam with blood tests. A sample
of tumor tissue may be collected.
Participants will undergo re-irradiation planning: They will wear a plastic mask over
their head during imaging scans. These scans will pinpoint the exact location of the
tumor. This spot will be the target of the radiation treatments.
Participants will undergo radiation treatment 4 times per week. Some people will have
this treatment for 3 weeks, some for 2 weeks, and some for 1 week. Blood tests and other
exams will be repeated at each visit.
Participants will complete questionnaires about their physical and mental health. They
will answer these questions before starting radiation treatment; once a week during
treatment; and at intervals for up to 3 years after treatment ends.
Participants will have follow-up visits 1 month after treatment and then every 2 months
for 6 months. Follow-up clinic visits will continue up to 3 years. Follow-ups by phone or
email will continue an additional 2 years.
Type: Interventional
Start Date: Oct 2024
open study
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Pembrolizumab, Lenvatinib and IL-15 Superagonist N-803 in Combination With HER2 Targeting Autologou1
National Cancer Institute (NCI)
Endometrial Cancer
Cancer of Endometrium
Carcinoma of Endometrium
Endometrial Carcinoma
Background:
Endometrial cancer (EC) of the uterus is becoming more common in the US. Sometimes EC
often has increased levels of a protein called HER2. Cancers with HER2 tend to be more
aggressive and have poorer outcomes.
Objective:
To test 2 study drugs-a vaccine that targets HER2 (AdHER2DC) pl1 expand
Background:
Endometrial cancer (EC) of the uterus is becoming more common in the US. Sometimes EC
often has increased levels of a protein called HER2. Cancers with HER2 tend to be more
aggressive and have poorer outcomes.
Objective:
To test 2 study drugs-a vaccine that targets HER2 (AdHER2DC) plus a drug that
supercharges immune cells that kill tumor cells (N-803)-combined with 2 FDA-approved
cancer treatment drugs in people with EC.
Eligibility:
Adults aged 18 and older with HER2-positive EC that returned or got worse after
treatment.
Design:
AdHER2DC vaccine is made from each participant s own blood. Participants will undergo
apheresis: Blood is removed from the body through a tube attached to a needle. The blood
passes through a machine that separates out the target cells. The remaining blood is
returned to the body through a second needle. A special catheter may be needed.
The first treatment cycle is 28 days; each cycle after that will be 21 days.
All participants will get the 2 approved drugs and the vaccine. One drug is a tablet
taken by mouth once a day, every day. The other drug is given through a tube attached to
a needle inserted into a vein.
The vaccine is injected under the skin. Participants will receive the vaccine on day 1 of
cycles 1, 2, and 3. Additional doses up to 3 doses will be give if possible.
Some participants will receive N-803. This drug is injected under the skin of the abdomen
on day 1 of each cycle.
Treatment may last up to 1 year. Follow-up visits will continue up to 2 more years.
Type: Interventional
Start Date: May 2024
open study
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Study of Aerosolized Antibiotics and Pembrolizumab in Advanced Non-small Cell Lung Cancer
National Cancer Institute (NCI)
Advanced Non Small Cell Lung Cancer
Background:
Non-small cell lung cancer (NSCLC) can be hard to treat and is often fatal. People with
NSCLC commonly have changes in the bacteria that populate their lungs. These bacterial
changes may aid tumor growth. Researchers want to find out if treating the bacteria, too,
can help cancer treat1 expand
Background:
Non-small cell lung cancer (NSCLC) can be hard to treat and is often fatal. People with
NSCLC commonly have changes in the bacteria that populate their lungs. These bacterial
changes may aid tumor growth. Researchers want to find out if treating the bacteria, too,
can help cancer treatment work better.
Objective:
To test 2 inhaled antibiotics (aztreonam and vancomycin), combined with a standard cancer
treatment, in people with NSCLC.
Eligibility:
People aged 18 years and older with NSCLC that has returned or progressed after treatment
and cannot be treated with surgery.
Design:
Participants will be screened. They will have a physical exam with blood tests. They may
blow into a machine to test how well their lungs work. They will have imaging scans. They
may need to have a small piece of tissue cut from their tumor (biopsy).
Participants will be treated in six 21-day cycles. They will visit the clinic to receive
a drug for cancer treatment on the first day of each cycle. This drug will be
administered through a tube attached to a needle inserted into a vein in the arm.
The 2 antibiotic drugs will be in the form of a fine mist that can be inhaled.
Participants use a device to take these drugs at home. They will inhale aztreonam up to 3
times a day and vancomycin 1 or 2 times a day. They will take these drugs during only 3
of the treatment cycles.
Biopsies and other tests will be repeated halfway through and after the study treatment.
Follow-up visits will continue for 1 year after study treatment.
Type: Interventional
Start Date: Apr 2024
open study
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Apheresis and Specimen Collection Procedures to Obtain Plasma, Peripheral Blood Mononuclear Cells (1
National Institute of Allergy and Infectious Diseases (NIAID)
Sample Collection
This study collects specimens from volunteers for use in studies by NIAID's Vaccine
Research Center. A number of different types of specimens or samples can be collected,
including blood, urine, body fluids or secretions, skin swabs, or skin biopsies. The
samples are used for medical research, incl1 expand
This study collects specimens from volunteers for use in studies by NIAID's Vaccine
Research Center. A number of different types of specimens or samples can be collected,
including blood, urine, body fluids or secretions, skin swabs, or skin biopsies. The
samples are used for medical research, including the study of HIV, hepatitis, and other
diseases; immune system responses, such as responses to vaccinations or infections; and
for research on vaccine development.
Blood samples may be collected either by ordinary blood drawing (phlebotomy) or by
apheresis, a procedure for collecting a larger quantity of blood cells or plasma than
would be possible through simple blood drawing. For this procedure, the participant lies
on a recliner or couch. Blood is removed through a needle in the vein of one arm and spun
in a machine that separates out the desired component (plasma or white blood cells). The
remainder of the blood is returned either through the same needle or through a needle in
the other arm. The procedure takes about 1 to 3 hours.
Volunteers who are 18 years of age and older, including participants in other NIH
research protocols, may be eligible. Individuals who have a condition that the research
staff considers a reason not to make a sample donation will be excluded from the study.
Participants may have only one sample collected or may be asked to undergo repetitive
sample collection procedures, depending upon the requirements of the particular research
project for which the samples are being collected. Each individual's enrollment is for a
1-year period, which can be extended.
Type: Observational
Start Date: Sep 2003
open study
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Central Nervous System Uptake of Anti-CD8+ T Cell Minibodies in Multiple Sclerosis and Progressive1
National Institute of Neurological Disorders and Stroke (NINDS)
Multiple Sclerosis
Progressive Multifocal Leukoencephalopathy
Background:
Multiple sclerosis (MS) and progressive multifocal leukoencephalopathy (PML) are
disorders that affect the central nervous system (CNS). The CNS includes the brain,
spinal cord, and optic nerves. Both diseases can cause muscle weakness and impair vision,
speech, and coordination. Resea1 expand
Background:
Multiple sclerosis (MS) and progressive multifocal leukoencephalopathy (PML) are
disorders that affect the central nervous system (CNS). The CNS includes the brain,
spinal cord, and optic nerves. Both diseases can cause muscle weakness and impair vision,
speech, and coordination. Researchers are working to better understand how MS and PML
affect the CNS.
Objective: To test whether an experimental radioactive tracer (minibody) can help
positron emission tomography (PET) scans detect certain immune cells in the CNS of people
with MS and PML.
Eligibility:
People aged 18 years and older with MS, other neuroinflammatory diseases with BBB
leakage, or PML.
Design:
Participants will come to the clinic for at least 3 visits over 4 to 6 weeks.
Participants will undergo testing. They will have a physical and neurological exam. They
will have blood tests and tests of their heart function. They will have a magnetic
resonance imaging (MRI) scan of the brain. They may have a spinal tap: Their lower back
will be numbed, and a needle will be inserted between the bones of the spine to withdraw
fluid from around the spinal cord.
Minibody is given through a tube with a needle placed in a vein in the arm. This takes 5
to 10 minutes. Participants will have heart function tests before and after receiving the
minibody.
Participants may have a PET scan on the day of the Minibody and will return the next day
for another PET scan. They will lie on a table that moves through a doughnut-shaped
machine. This scan will take about 1 hour.
Participants with PML may opt to repeat the minibody infusion and the PET scan within 6
months.
Type: Interventional
Start Date: Oct 2023
open study
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Collection of Blood and Urine Samples in Patients Receiving Radiation Therapy for Glioblastoma Mult1
National Cancer Institute (NCI)
Glioblastoma Multiforme
This study will collect blood and urine samples from patients undergoing radiation
therapy for glioblastoma multiforme (a type of brain tumor) to investigate the effects of
this treatment on blood cells and certain proteins. The information from this study may
help scientists develop new tests to m1 expand
This study will collect blood and urine samples from patients undergoing radiation
therapy for glioblastoma multiforme (a type of brain tumor) to investigate the effects of
this treatment on blood cells and certain proteins. The information from this study may
help scientists develop new tests to measure radiation exposure and find new ways to
treat cancer with radiation, and help determine which kinds of patients or tumors respond
better to radiation therapy. Two proteins of particular interest in this study and which
may be involved in the recurrence of cancer are VEGF (vascular endothelial growth factor)
and MMPs (matrix metalloproteinases).
Patients 18 years of age and older with glioblastoma multiforme who are receiving or will
receive radiation therapy as part of their medical treatment may be eligible for this
study. Candidates are screened with a history and physical examination, blood tests, and
magnetic resonance imaging (MRI) of the brain.
Participants will have blood and urine samples collected before, during and after
completion of their radiation treatment. Urine samples are collected in a cup and about 2
tablespoons of blood are withdrawn through a needle in a vein. Additional samples may be
requested at different times during treatment and in the 3-year follow-up period.
Type: Observational
Start Date: Jun 2004
open study
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Evaluation of Late Effects and Natural History of Disease in Patients Treated With Radiotherapy
National Cancer Institute (NCI)
Cancer
BACKGROUND
- This protocol acknowledges that it is in the interest of the NIH and ROB, as well as
our participants, to continue to follow those who have been treated with
radiotherapy at ROB and are not otherwise eligible for current active research
protocols.
- It also provi1 expand
BACKGROUND
- This protocol acknowledges that it is in the interest of the NIH and ROB, as well as
our participants, to continue to follow those who have been treated with
radiotherapy at ROB and are not otherwise eligible for current active research
protocols.
- It also provides a mechanism for the correlation and interpretation of disparate
data for research into the long term side effects and outcomes for a variety of
disease entities and treatments, such as combined modality treatment, MoAb, PDT,
radiation modifiers,
intraoperative radiotherapy, etc.
OBJECTIVE
-The primary objective of this protocol is to assess the late effects of treatment and
the natural history of disease through collection of data from any standard procedures
performed as part of follow up care on participants previously treated with radiotherapy.
ELIGIBILITY
-Participants who received radiation therapy.
DESIGN
- This is a natural history protocol in which long-term follow up data will be
collected from participants who received radiation therapy.
- It will be made clear to participants in the consent form, that data collected
during their follow-up may be used anonymously for publications concerning the
natural history of disease processes and long-term effects of treatment.
Type: Observational
Start Date: Feb 2000
open study
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Immune System Related Kidney Disease
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Kidney Disease
Nephrotic Syndrome
Kidney diseases related to the immune system include, nephrotic syndrome,
glomerulonephritis, membranous nephropathy, lupus nephritis, and nephritis associated
with connective tissue disorders.
This study will allow researchers to admit and follow patients suffering from autoimmune
diseases of the1 expand
Kidney diseases related to the immune system include, nephrotic syndrome,
glomerulonephritis, membranous nephropathy, lupus nephritis, and nephritis associated
with connective tissue disorders.
This study will allow researchers to admit and follow patients suffering from autoimmune
diseases of the kidney. It will attempt to provide information about the causes and
specific abnormalities associated with autoimmune kidney disease.
Patients with kidney disease as a result of their immune system, and patients with
diseases of the immune system who may later develop kidney disease, will be potential
subjects for this study.
Patients will undergo a history and physical examination, and standard laboratory test to
more closely understand the causes, signs, symptoms, and responses to medication of these
diseases. Based on these evaluations the patients may qualify as candidates for other
experimental studies. At any time these patients may be asked to submit blood or urine
samples for further research.
Type: Observational
Start Date: Jun 1992
open study
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Metagenomics Next-generation Sequencing Approach to Detect Microbial DNA/RNA Overtime in Individual1
National Institutes of Health Clinical Center (CC)
Hematopoietic Stem Cell Transplantation
Infections are a major cause of morbidity and mortality in patients undergoing
hematopoietic stem cell transplant (HSCT). The purpose of this study is to evaluate if
metagenomic next-generation sequencing (mNGS) can detect microbial signatures in people
undergoing HSCT, and if microbial identificat1 expand
Infections are a major cause of morbidity and mortality in patients undergoing
hematopoietic stem cell transplant (HSCT). The purpose of this study is to evaluate if
metagenomic next-generation sequencing (mNGS) can detect microbial signatures in people
undergoing HSCT, and if microbial identification can be correlated with clinical features
of infection (e.g., fever). Participants undergoing HSCT as part of other studies at the
NIH Clinical Center (CC) will provide blood before the transplant and through 6 months
after. Total nucleic acid will be extracted from plasma and subjected to mNGS.
The primary objective of this study is to investigate if by using plasma and an mNGS
approach, we can detect bacterial, fungal, protozoan, or viral DNA/RNA over time, in
immunocompromised patients undergoing transplantation.
Secondary objectives are to: (1) To correlate microbial identification with episodes of
fever or clinical suspicion of infection; and to (2) correlate change in microbial
signatures in patients with suspected immune reconstitution inflammatory syndrome.
The study is conducted at the NIH Clinical Center. Participants, aged 3 years and older,
on other research studies at the NIH CC who are undergoing HSCT are invited to take part
of this study. Expected participation is up to six months.
Type: Observational
Start Date: Apr 2025
open study
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Natural History Study of Parathyroid Disorders
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Parathyroid Cancer
Primary Hyperparathyroidism
Pseudohypoparathyroidism
Inheritable Bone Diseases
Multiple Endocrine Neoplasia, Type 1
Background:
Parathyroid disorders are very common in the general population and include disorders of
parathyroid excess, deficiency, or defects in parathyroid hormone (PTH) signaling. PTH,
the main secretory product of parathyroid glands is responsible for regulation of
calcium-phosphate homeostas1 expand
Background:
Parathyroid disorders are very common in the general population and include disorders of
parathyroid excess, deficiency, or defects in parathyroid hormone (PTH) signaling. PTH,
the main secretory product of parathyroid glands is responsible for regulation of
calcium-phosphate homeostasis.
Objective:
i) To investigate the cause of parathyroid disorders
ii) To describe evolution, natural history, and longitudinal trends of parathyroid and
related disorders seen in syndromic presentations like multiple endocrine neoplasia,
hyperparathyroidism-jaw tumor syndrome
Eligibility:
People ages 6 months older who have, are at risk of having, or are related to a person
with a parathyroid or related disorder.
Design:
Participants will be screened with a review of their medical records.
Participants will be seen, tested, and treated by doctors based on their condition. Their
visits may be in person or via telehealth.
Participants will complete questionnaires. They will answer questions about their
physical, mental, and social health.
Participants may give samples such as saliva, blood, urine, or stool.
Participants may give cheek cell samples. They will do this using a cheek swab or by
spitting into a cup.
Adult participants may give a skin biopsy. For this, a small bit of skin is removed with
a punch tool.
Participants may have medical photos taken.
If participants have surgery during the course of their regular care either at the NIH
or at a different hospital or doctor s office, researchers will ask for some of the
leftover
tissue.
Participants will be in the study as long as they are being seen by their doctor.
Type: Observational
Start Date: Nov 2021
open study
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Developing Brain, Impulsivity and Compulsivity
National Institute of Mental Health (NIMH)
Typical Development
Obsessive Compulsive Disorder
Conduct Disorder
Attention Deficit Hyperactivity Disorder
Autism Spectrum Disorder
Background:
Impulsivity is acting 'without thinking.' Compulsivity is being overly inflexible. People
vary in how impulsive or compulsive they are. Extreme versions of these behaviors play a
role in mental disorders. Researchers want to study changes in the brain to learn more
about these behavior1 expand
Background:
Impulsivity is acting 'without thinking.' Compulsivity is being overly inflexible. People
vary in how impulsive or compulsive they are. Extreme versions of these behaviors play a
role in mental disorders. Researchers want to study changes in the brain to learn more
about these behaviors. Differences in genes may also play a role.
Objective:
To learn about genetic & brain features that explain why levels of impulsivity and
compulsivity vary across people.
Eligibility:
People ages 6 - 80
Design:
Participants will be screened with a medical history and medical record review.
Participants will talk about their mental and behavioral development. They may discuss
topics like drug use and sexual activity. They will complete surveys about their
compulsivity and impulsivity. Parents of child participants may also complete these
surveys.
Participants may take memory, attention, and thinking tests. They may give blood or
saliva samples for gene studies and they may give blood to make induced pluripotent stem
cells. Participants may have their face and irises photographs taken.
Participants may have a magnetic resonance imaging scan. It will take pictures of their
brain. The scanner is shaped like a cylinder. Participants will lie on a table that
slides in and out of the scanner. A coil will be placed over their head. They will lie
still, watch a movie, and play a game.
Participants may ask family members to join the study. Researchers are particularly
interested in recruiting twin pairs to the study.
Participants under age 25 may repeat these tests every 1-2 years until they turn 25 or
until the study ends. For those over age 25, participation will last less than 1 month.
Type: Observational
Start Date: Sep 2022
open study
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The Use of 124-I-PET/CT Whole Body and Lesional Dosimetry in Differentiated Thyroid Cancer
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Thyroid Cancer
Study rationale
High risk patients with differentiated thyroid cancer (DTC) require therapy with 131 I
under thyroid stimulating hormone (TSH) stimulation. There are two methods of TSH
stimulation endogenous by thyroid hormone withdrawal (THW) leading to hypothyroidism and
exogenous by injection o1 expand
Study rationale
High risk patients with differentiated thyroid cancer (DTC) require therapy with 131 I
under thyroid stimulating hormone (TSH) stimulation. There are two methods of TSH
stimulation endogenous by thyroid hormone withdrawal (THW) leading to hypothyroidism and
exogenous by injection of human recombinant TSH (rhTSH Thyrogen). The appropriate 131-I
activity utilized for treatment is either based on empiric fixed dosage choice or
individually determined activity based on 131 I dosimetric calculations. Although
dosimetry utilizing radioactive iodine isotope 131 I enables calculation of maximum safe
dose, it does not estimate the tumoricidal activity necessary to destroy the metastatic
lesions. The alternative radioactive isotope of iodine -124 I, used for positron emission
tomography (PET) imaging, might be used for calculation not only the maximum safe131 I
dose, but also to predict the absorbed dose in the metastatic lesions.
Study objectives
The primary objective of this study is to compare the 124 I -PET/CT lesional and whole
body dosimetry in each individual patient with metastatic radioiodine (RAI)-avid thyroid
cancer under preparation with rhTSH and THW. The secondary objective is to evaluate the
predicted by PET/CT lesional uptake with the early response to therapy.
Study design
This is a phase 2 pilot prospective cohort study comparing the lesional and whole body
dosimetry within each patient undergoing exogenous (rhTSH) and endogenous (THW) TSH
stimulation and followed for 5 years.
Interventions
Each study participant will undergo rhTSH and THW-aided 124 I-PET/CT dosimetric
evaluations and will be subsequently treated with THW-aided RAI activity based on
dosimetric calculations enabling maximum safe dosage. The patients will be followed in
12+/-3 months intervals for 5 years.
Sample size and population
This pilot study will include 30 patients with high risk differentiated thyroid cancer
presenting with distant and/or loco-regional metastases.
Type: Interventional
Start Date: Jul 2019
open study
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Characterization and Treatment of Adolescent Depression
National Institute of Mental Health (NIMH)
Depression
This research study seeks to find causes and treatments of depression in teenagers. The
study goals are to increase our knowledge of treatments for depression and understand how
the brain changes when teenagers have depression. The study will also compare teenagers
with depression to those without1 expand
This research study seeks to find causes and treatments of depression in teenagers. The
study goals are to increase our knowledge of treatments for depression and understand how
the brain changes when teenagers have depression. The study will also compare teenagers
with depression to those without mental health diagnoses.
This outpatient study is recruiting participants ages 11-17 who are depressed. They must
have a pediatrician or other medical provider, be medically healthy, and able to perform
research tasks. They may not currently be hospitalized, psychotic or actively suicidal.
Teenagers with depression are eligible even if they are taking medication.
The study begins with an evaluation that includes clinical assessment, interviews, and
questionnaires.
- Visits may include paper-and-pencil and computer tests of mood, memory, and
thinking; specialized computer games; and structural and brain imaging. If eligible,
study participants may return several times a year for up to two years. This part of
the study does not involve treatment.
- Participants may be eligible for outpatient treatment for up to 25 weeks. This
includes evidenced-based "talk" therapy. Participants may choose either
Interpersonal Psychotherapy for Adolescents (IPT-A) or Cognitive Behavioral Therapy
(CBT). If indicated, participants may opt to receive standard medication treatments
along with psychotherapy. Research includes computer tasks and brain imaging.
All clinical evaluations, research tasks and visits are free of cost. Participants are
compensated for research activities. Parents and teenager must agree to the teenager s
participation in research.
The study is conducted at the NIH in Bethesda, Maryland and enrolls participants from the
Washington DC Metro region within 50 miles of NIH. Transportation expenses are reimbursed
by NIMH.
Type: Observational
Start Date: Dec 2017
open study
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Study of Systemic Lupus Erythematosus
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Systemic Lupus Erythematosus
This protocol will evaluate patients with systemic lupus erythematosus (SLE) and their
relatives to learn more about how the disease develops and changes over time. It will
also study genetic factors that make a person susceptible to SLE.
Patients 3 years of age and older with known or suspected S1 expand
This protocol will evaluate patients with systemic lupus erythematosus (SLE) and their
relatives to learn more about how the disease develops and changes over time. It will
also study genetic factors that make a person susceptible to SLE.
Patients 3 years of age and older with known or suspected SLE and their relatives may be
eligible for this study. Patients will be evaluated with a medical history and physical
examination, blood and urine tests. Other procedures may include:
1. Electrocardiogram
2. 24-hour urine collection
3. Imaging studies, such as chest and joint X-rays, magnetic resonance imaging (MRI)
scans, bone scans, and bone densitometry.
4. Questionnaire about the degree of disease activity, and survey of risk factors for
disease complications.
5. Apheresis-Collection of plasma (fluid portion of blood) or blood cells for analysis.
Whole blood is collected through a needle in an arm vein. The blood circulates
through a machine that separates it into its components. The required component
(plasma or cells) is removed and the rest of the blood is returned to the body
through the same needle or through a second needle in the other arm.
6. Skin biopsy-Removal of a small skin sample for microscopic analysis. An area of skin
is numbed with an anesthetic and a small circular portion (about 1/4 inch in
diameter) is removed, using a sharp cookie cutter-type instrument.
7. Kidney, bone marrow or other organ biopsy-Removal of a small sample of organ tissue.
These biopsies are done only if they can provide information useful in better
understanding the disease or making treatment decisions.
8. Genetic studies-Collection of a blood sample for gene testing.
Patients will be followed at least once a year with a brief history and physical
examination and routine blood and urine tests. Some patients may be seen more often.
Treatment recommendations will be offered to patients' physicians, and patients who are
eligible for other research treatment studies will be invited to enroll.
Participating relatives of patients will fill out a brief medical history questionnaire
and provide a DNA sample (either a blood sample or tissue swab from the inside of the
cheek) for genetic testing.
Type: Observational
Start Date: Feb 1994
open study
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Engaging Mental Effort: Process- and Person-Based Reward Experiences, Effort Reinforcement Interven1
University of California, Davis
Performance vs. Effort Rewards
Brief Summary: The goal of this clinical trial is to investigate the influences of
children's prior experiences with rewards following successes at school and interventions
aimed at influencing children's preferences for challenging cognitive tasks.
The main questions this study aims to answer are1 expand
Brief Summary: The goal of this clinical trial is to investigate the influences of
children's prior experiences with rewards following successes at school and interventions
aimed at influencing children's preferences for challenging cognitive tasks.
The main questions this study aims to answer are as follows:
1. Does the frequency of process-based rewards (e.g., rewards for working hard) vs.
outcomes-based rewards (i.e., rewards for a good grade) predict children's
preferences for challenging cognitive tasks?
2. Does providing rewards for taking on effortful cognitive tasks increase children's
preferences for challenging cognitive tasks more than providing rewards for
performing well on cognitive tasks?
3. Does receiving rewards for taking on effortful cognitive tasks increase children's
challenge-seeking in novel tasks and questionnaires relevant for academic
achievement that have not been previously linked with rewards?
Participants will complete the following tasks:
1. A matrix completion problem solving task, with options to seek tips for solving
problems and options to quit early.
2. A response inhibition task, with options to complete a harder or easier version of
the task.
3. A cognitive flexibility task, with options to complete a harder or easier version of
the task.
4. A puzzle completion task, with an option to quit early.
5. Answer a set of questions about academic effort
6. Parents will complete a set of questions about how they responded to children's
recent successes and failures at school.
Type: Interventional
Start Date: Apr 2026
open study
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Patient Quality of Recovery After TAVR With Different Sedation Regimens
David Lyubashevsky
Transcatheter Aortic Valve Replacement (TAVR)
Aortic Valve Stenosis
The goal of this clinical trial is to learn whether the type of sedation medication used
during a transcatheter aortic valve replacement (TAVR) affects how people recover after
the procedure. The main question this study aims to answer is whether different sedation
regimens (propofol, dexmedetomidi1 expand
The goal of this clinical trial is to learn whether the type of sedation medication used
during a transcatheter aortic valve replacement (TAVR) affects how people recover after
the procedure. The main question this study aims to answer is whether different sedation
regimens (propofol, dexmedetomidine, or midazolam with fentanyl) lead to differences in
quality of recovery on the first day after the procedure.
Researchers will compare three commonly used sedation medications (propofol,
dexmedetomidine, or midazolam with fentanyl) to determine whether they lead to
differences in recovery following a TAVR.
Participants will:
- Be enrolled before their scheduled TAVR procedure
- Be randomly assigned to receive one of the three sedation medications during their
procedure
- Complete short surveys on postoperative days 1 and 7 about pain levels, how they
feel during their recovery, and how satisfied they were with their anesthesia
experience
Type: Interventional
Start Date: Mar 2026
open study
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A Study Evaluating Disease Characteristics and Outcomes in Participants With Asthma in Routine Clin1
Sanofi
Asthma
The main aim of the study to describe the characteristics of participants with asthma
across the spectrum of disease severity, including sociodemographic and clinical
characteristics, treatment and disease burden, biomarkers, and both disease-specific and
generic health-related quality of life.
Th1 expand
The main aim of the study to describe the characteristics of participants with asthma
across the spectrum of disease severity, including sociodemographic and clinical
characteristics, treatment and disease burden, biomarkers, and both disease-specific and
generic health-related quality of life.
The study consists of two parts: a cross-sectional study, and a prospective follow-up
evaluate changes in disease trajectories in participants with asthma.
Type: Observational [Patient Registry]
Start Date: Apr 2026
open study
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Vibratory Anesthesia on Pain Following Corticosteroid Injections
The University of Texas Medical Branch, Galveston
Bilateral Arthritis of Wrist
Tendinopathy
Arthropathy
Compression Neuropathy
Bilateral Arthritis of Hands
This research study aims to evaluate injectional pain at the site of needle insertion for
corticosteroid injections (CSI) of the upper extremity depending on different modes of
anesthetics. Each individual's perception of pain upon receiving a CSI with two out of
three modes of anesthesia (control/1 expand
This research study aims to evaluate injectional pain at the site of needle insertion for
corticosteroid injections (CSI) of the upper extremity depending on different modes of
anesthetics. Each individual's perception of pain upon receiving a CSI with two out of
three modes of anesthesia (control/no anesthesia, vibrational anesthesia, vapo-coolant
anesthesia) will be utilized to compare these variables and determine the method that is
associated with the least pain.
Type: Interventional
Start Date: Apr 2026
open study
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A Study to Evaluate the Effect of Food on the Bioavailability of AJ201, and Safety, Tolerability, a1
AnnJi Pharmaceutical Co., Ltd.
Healthy Male Adults
Food Effect in Healthy Volunteers
This is a Phase 1, randomized, single-dose, open-label, two-way crossover study to
evaluate the effect of food on AJ201, and to evaluate the safety, tolerability, and
pharmacokinetics of AJ201 in Japanese and White healthy male participants. expand
This is a Phase 1, randomized, single-dose, open-label, two-way crossover study to
evaluate the effect of food on AJ201, and to evaluate the safety, tolerability, and
pharmacokinetics of AJ201 in Japanese and White healthy male participants.
Type: Interventional
Start Date: Apr 2026
open study
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A Safety and Efficacy Study of hu14 in High-Risk Neuroblastoma Patients
Renaissance Pharma Ltd.
High-Risk Neuroblastoma
Neuroblastoma is the most common type of solid cancer found outside the brain in young
children. Generally, it affects children younger than 5 years old, with the average age
when it is found being just 2 years. Most patients have 'high-risk' disease, with spread
of the disease to different sites (1 expand
Neuroblastoma is the most common type of solid cancer found outside the brain in young
children. Generally, it affects children younger than 5 years old, with the average age
when it is found being just 2 years. Most patients have 'high-risk' disease, with spread
of the disease to different sites (metastases). This multinational study aims to find out
how effective and safe the treatment of a monoclonal anti-GD2 antibody hu14.18K322A
(daretabart) is when used together with chemotherapy to treat children and young people
who have high-risk neuroblastoma.
Type: Interventional
Start Date: Apr 2026
open study
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