
Search Clinical Trials
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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 6 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 |
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Characterization of Patients With Uncommon Presentations and/or Uncommon Diseases Associated With t1
National Heart, Lung, and Blood Institute (NHLBI)
Metabolic Disease
Obesity
Li-Fraumeni Syndrome
Cardiomyopathy
Atherosclerosis
Background:
- Researchers are interested in studying individuals who have known or suspected
metabolic, inflammatory or genetic diseases that may put them at a high risk for heart
diseases or diseases of their blood vessels. Depending on the condition being studied,
both affected and nonaffected i1 expand
Background: - Researchers are interested in studying individuals who have known or suspected metabolic, inflammatory or genetic diseases that may put them at a high risk for heart diseases or diseases of their blood vessels. Depending on the condition being studied, both affected and nonaffected individuals may be asked to provide blood and other samples and may undergo tests to evaluate the heart, blood vessels and lung function. The testing is tailored to the individual and/or condition being studied. Nonaffected individuals may include relatives of affected individuals and healthy nonrelated volunteers. Objectives: - To study individuals who have or are at risk for cardiovascular diseases, and in some cases their unaffected relatives and healthy volunteers. Eligibility: - Individuals between 1 and 100 years of age. Participants may be healthy volunteers, individuals with cardiovascular diseases, or unaffected relatives of individuals with cardiovascular diseases. Design: - Participants will have some or all of the following tests, as directed by the study researchers: - Photography of the face and full body - Body measurements - Radiography, including chest or limb x-rays - Metabolic stress testing to study heart and muscle function - Echocardiography to study heart function - Magnetic resonance imaging (MRI) studies, including cardiovascular MRI, angiography, and contrast MRI, to study heart function and performance - Computed tomography (CT) angiogram to obtain images of the heart and lungs - Positron emission tomography (PET) imaging to study possible fat infiltration of the heart - Six-minute walk test to study heart, lung, and muscle function and performance - Vascular ultrasound to study blood vessel walls - Blood, tissue, and other specimens will be collected for research and testing, and will be taken either as part of the clinical study or during surgical procedures. - Follow-up studies may be performed under separate research protocols. Type: Observational Start Date: Jul 2010 |
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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 |
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Accuracy of 18F-Fluorocholine PET/MR and NeuroEXPLORER PET/CT Imaging for Localization of Parathyro1
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Primary Hyperparathyroidism
Parathyroid Cancer
Multiple Endocrine Neoplasias
Heritable Hyperparathyroidism
Hyperparathyroid-jaw Tumor Syndrome
Background:
People have 4 parathyroid glands near the thyroid gland in the neck. Surgery is needed to
remove a parathyroid gland that is too large or has a tumor. These glands can be in
different places, so doctors use an imaging scan with contrast dye to help find them
before surgery. Researchers1 expand
Background: People have 4 parathyroid glands near the thyroid gland in the neck. Surgery is needed to remove a parathyroid gland that is too large or has a tumor. These glands can be in different places, so doctors use an imaging scan with contrast dye to help find them before surgery. Researchers want to know if a different type of scan and a new tracer can make it easier to find the tumors in the parathyroid glands. Objective: To see if PET/MRI and NeuroEXPLORER PET-CT scans with a 18F-FCH tracer are better than existing methods for finding the parathyroid glands. Eligibility: People aged 18 years or older who are scheduled for surgery to remove a parathyroid gland. Design: Participants will have up to 4 clinic or hospital visits. They will be screened. They will have a physical exam and give blood samples. Participants will have a 4-dimensional computed tomography (4D-CT) scan. This is the current way doctors look for parathyroid glands. They will be injected with an iodine-based dye for the 4D-CT scan. They will lie on a padded table that slides into a donut-shaped machine. Participants will have a positron emission tomography (PET)-magnetic resonance imaging (MRI) and NeuroEXPLORER PET-CT scan. For these scans, they will be injected with a radioactive tracer (18F-FCH). They will wait about 30 to 60 minutes for their body to absorb the tracer. They will lie on a padded table that slides into a tube. Their vital signs will be monitored during the scan. Participants will have surgery to remove the target gland. They may need to stay in the hospital for up to 3 nights. Participants will have a follow-up visit 6 months after the surgery. This may be done remotely.... Type: Interventional Start Date: Apr 2026 |
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Surface Electrical Stimulation for Urinary Incontinence in Men Treated for Prostate Cancer
National Cancer Institute (NCI)
Urinary Urge Incontinence
Stress Urinary Incontinence
Prostatic Hyperplasia
Background:
Men who are treated for prostate cancer often develop urinary leakage (incontinence). An
experimental device that uses electrical impulses to stimulate pelvic floor muscles and
surrounding tissues may help.
Objective:
To see if the Elidah device can reduce urinary incontinence after1 expand
Background: Men who are treated for prostate cancer often develop urinary leakage (incontinence). An experimental device that uses electrical impulses to stimulate pelvic floor muscles and surrounding tissues may help. Objective: To see if the Elidah device can reduce urinary incontinence after prostate treatment. Eligibility: Men aged 18 years and older who have had moderate urinary incontinence for at least 6 months after treatment for prostate cancer. Design: Participants will be in the study for about 9 weeks. They will be screened. They will have a physical exam with urine tests. The Elidah device consists of a Controller and a GelPad. The Controller sets the strength of electrical impulses. The GelPad is placed against the skin under the pelvis. Participants will be given an Elidah device and taught how to use it at home. They will use the device once a day for 20 minutes at a time; they will do this 5 days a week for 6 weeks. Participants will complete a daily log. They will record the strength of electrical impulses (0-35); the number of incontinence episodes; the type of incontinence episode; and the number of used pads. Participants will do a pad weight test. For 3 days before and 3 days after using the Elidah device, they will collect all of their used pads for each 24-hour period into a sealed plastic bag. They will also collect a second set of bags that contain dry versions of each product used. Participants will have clinic visits after using the device for 3 weeks and after finishing the 6 weeks of treatment. Participants will complete 15-minute questionnaires. Type: Interventional Start Date: Feb 2024 |
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18F-DCFPyL Imaging as a Method to Assess Treatment Response to Stereotactic Body Radiation Therapy
National Cancer Institute (NCI)
Localized Prostate Cancer
Background:
Identifying medium- and high-risk prostate cancer early may allow for treatments to work.
But identification can be hard. Researchers want to see if a radiotracer used during PET
scans can help.
Objective:
To test how an imaging agent called 18F-DCFPyL detects response to standard pr1 expand
Background: Identifying medium- and high-risk prostate cancer early may allow for treatments to work. But identification can be hard. Researchers want to see if a radiotracer used during PET scans can help. Objective: To test how an imaging agent called 18F-DCFPyL detects response to standard prostate cancer treatment. Eligibility: People ages 18 and older with newly diagnosed prostate cancer who have no evidence of distant metastatic disease and plan to get stereotactic body radiation therapy (SBRT) with or without androgen deprivation therapy (ADT). Design: Participants will be screened with: Medical history Physical exam Blood tests MRI Participants will have baseline MRI and PET/CT scans. For the MRI, they may get a contrast agent by IV injection. For the PET/CT scan, they will get an IV injection of 18FDCFPyL. About 1 to 2 hours later, they will get the PET/CT scan. During the scans, participants will lie on their back and remain still for 45 minutes to 1 hour. These scans will be repeated at different points during the study. Participants will get SBRT with or without ADT. Participants will complete questionnaires about their quality of life. Participants will be asked about any symptoms they are having. They will also be asked about medications they are using. They may have a physical exam. Participants will give blood and urine samples. They will give a tumor sample from a biopsy they have had in the past. After treatment, participants will have follow-up visits. These will occur 1 month after treatment, then every 3 months for a year, and then every 6 months for 1 more year. Type: Interventional Start Date: Aug 2022 |
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Natural History Study of Clinical and Biological Factors Determining Outcomes in Chronic Graft-Vers1
National Cancer Institute (NCI)
Chronic Graft vs. Host Disease
Background:
- Chronic graft-versus-host disease (cGVHD) is a multi-organ alloimmune and autoimmune
disorder that occurs following allogeneic hematopoietic stem cell transplantation
(alloHSCT). It is characterized by immune dysregulation, immunodeficiency, impaired
organ function,1 expand
Background: - Chronic graft-versus-host disease (cGVHD) is a multi-organ alloimmune and autoimmune disorder that occurs following allogeneic hematopoietic stem cell transplantation (alloHSCT). It is characterized by immune dysregulation, immunodeficiency, impaired organ function, and decreased survival. - Each year about 8000 patients receive allogeneic hematopoietic stem cell transplant (alloHSCT) in North America and about 50% of patients who are transplanted develop cGVHD. - Chronic GVHD is also a disorder that simultaneously affects many organ systems in highly variable fashion and requires complex and coordinated medical management by multiple medical specialties. There is an urgent need for progress in understanding and effective treatments for cGVHD as it is one of the most serious complications of cancer therapy and hematopoietic stem cell transplantation. Objectives: - To establish a multidisciplinary clinic infrastructure for study of the pathogenesis and natural history of cGVHD. - To prospectively identify clinical and biological prognostic markers in patients with cGVHD - To develop clinically relevant cGVHD grading scales - To identify novel biological characteristics of cGVHD and to describe them in the context of clinical history and presentation - To identify potential clinical and biological markers of cGVHD activity - To improve understanding of the biology of cGVHD-associated graft-versus-tumor effects - To identify potential patients for cGVHD treatment protocols at the NCI and NIH Eligibility: -Patients age 1 and older referred by the primary transplant physician for the evaluation of chronic graft-versus-host disease independent of underlying diagnosis. Design: - Patient undergoes initial clinical and laboratory multispecialty work-up at the NCI cGVHD clinic. - Minimally invasive biopsies and rarely, deep tissue biopsy may be obtained to confirm the diagnosis and/or rule-out other pathologic process (in adults only). - Long tem data collection for evaluation of long-term outcomes will be conducted anually as feasible Type: Observational Start Date: Oct 2004 |
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Pathogenesis and Genetics of Disseminated or Refractory Coccidioidomycosis
National Institute of Allergy and Infectious Diseases (NIAID)
Coccidioidomycosis
Background:
- Coccidioidomycosis is caused by a fungus that grows in the southwest United States and
parts of Mexico and South America. This disease is caused by breathing dust containing
the fungus. It can lead to serious lung and breathing problems. Rarely, the fungus can
infect other body parts1 expand
Background: - Coccidioidomycosis is caused by a fungus that grows in the southwest United States and parts of Mexico and South America. This disease is caused by breathing dust containing the fungus. It can lead to serious lung and breathing problems. Rarely, the fungus can infect other body parts. This is called disseminated coccidioidomycosis (DCM). If the fungus stays in the lungs for more than 6 months, it is called refractory coccidioidomycosis (RCM). People with DCM or RCM may have difficulty fighting off infection because of immune system problems. Researchers want to study the immune systems of people with DCM or RCM, to learn more about the disease and the best ways to treat it. They also want to learn more about the types of people that get DCM or RCM and about the fungus that causes it. Objectives: - To learn more about DCM and RCM, the fungus that causes these diseases, and the people who get them. Eligibility: - People over age 2 with DCM or RCM. Design: - Participants will be screened with a review of their medical records. - At the initial visit, participants will have: - Medical history and physical exam - Blood and urine tests. Some blood may be used for genetic testing. The samples will not include participants names. Participants will be notified only if the tests show something urgent about their DCM/RCM. Researchers think this sort of problem will be rare. - Questionnaire about their DCM/RCM - Sputum (mucus) collection. They will spit into a cup. - Participants will have 1 follow-up visit per year. They will have blood tests. They may have other procedures to treat their DCM/RCM. Type: Observational Start Date: Sep 2014 |
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Nicotinic Receptor Genetic Variation and Alcohol Reward
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Alcohol Drinking
Background:
People with the brain disease AUD (alcohol use disorder) have a serious problem with
drinking. Researchers want to study how different people react to alcohol, and how genes
affect this. They will focus on a nicotine receptor gene that may increase a person s AUD
risk.
Objectives:
To1 expand
Background: People with the brain disease AUD (alcohol use disorder) have a serious problem with drinking. Researchers want to study how different people react to alcohol, and how genes affect this. They will focus on a nicotine receptor gene that may increase a person s AUD risk. Objectives: To see if people with variations of a nicotine receptor gene take alcohol differently and have different brain responses to alcohol cues. Eligibility: Healthy adults ages 21 - 60. This study includes smokers and non-smokers. Design: Participation will be based on evaluation under the NIAAA natural history protocol (14-AA-0181) or a screening visit under this protocol. Participants will have two 9-hour visits. They must have no alcohol or non-prescription drugs before all visits and no food or drink before the first visit. At every visit, participants will: - Get a light meal - Have breath and urine tests - Get taxi rides there and back At visits 1, participants will: - Have a thin plastic tube inserted in an arm and connected to a pump for alcohol infusion. - Have sensors on their chest to monitor heart rate. - Sit in a chair for 2.5 hours and get alcohol by pushing a button. Their breath alcohol level will be monitored. - Answer questions about mood and effects of alcohol - Give blood samples - Relax at the clinic while their breath alcohol level drops At visit 2, participants will: - Answer questions and do computer tests - Have an alcoholic drink and a snack - Have a magnetic resonance imaging (MRI) scan. They will lie in a machine that takes pictures of the brain. They will do computer tasks. - Have another drink and snack - Relax until their alcohol level drops Participants will have a follow-up call after each visit. Type: Interventional Start Date: Jun 2019 |
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Collection of Tissue Specimens From Patients With Solid Tumors or Blood Disorders and Their HLA-Com1
National Heart, Lung, and Blood Institute (NHLBI)
Neoplasms
Hematologic Neoplasms
Healthy Volunteers
This study will collect biological samples for use in research experiments aimed at
better understanding the clinical features of certain diseases. The specimens may be used
to evaluate the effectiveness of known therapies, refine treatment approaches, identify
potential new therapies, and explore1 expand
This study will collect biological samples for use in research experiments aimed at better understanding the clinical features of certain diseases. The specimens may be used to evaluate the effectiveness of known therapies, refine treatment approaches, identify potential new therapies, and explore opportunities for disease prevention. The following individuals 2 years of age or older may be eligible for this study: - Patients with a cancerous solid tumor or a cancerous or non-cancerous blood disorder who are being screened for or who are enrolled in a treatment study at the NIH Clinical Center - HLA-compatible donor family members (18 years of age or older) of the above patients who are being evaluated for or are enrolled in an NIH study as a stem cell transplant donor - Patients with a cancerous solid tumor or a cancerous or non-cancerous blood disorder or a bone marrow failure condition who cannot participate in an NIH treatment protocol or travel to the NIH Clinical Center and who are referred for participation through their home health care provider. Research samples will be collected from participants when blood is drawn or bone marrow, urine, or stool is collected, or tumor or other tissue is biopsied as part of their general medical care. Investigators may periodically request an additional sample of blood, stool, or urine. Participants who are 18 years of age or older may donate a large number of white blood cells through a procedure called leukapheresis. This procedure is not part of general medical care and would be done for research purposes only. For apheresis, a catheter (plastic tube) is placed in a vein in the subject's arm. Blood flows from the vein into a cell separator machine, where the white cells are separated from the red cells, platelets, and plasma by a spinning process. The white cells are removed and collected, and the rest of the blood is returned to the subject through a second tube placed in the other arm. Type: Observational Start Date: Oct 2003 |
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Characterization Imaging Instruments in Alcoholics and Non-Alcoholics
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Alcohol Dependence
Alcohol Drinking
Alcohol-Related Disorders
Alcoholism
Brain Mapping
Background:
- People with alcoholism have differences in their brains compared with healthy people.
People who are dependent on alcohol also perform differently on behavioral tasks.
Researchers want to find out more about these differences. They also want to see if these
differences are related to1 expand
Background: - People with alcoholism have differences in their brains compared with healthy people. People who are dependent on alcohol also perform differently on behavioral tasks. Researchers want to find out more about these differences. They also want to see if these differences are related to DNA. Objective: - To see if differences in brain structure relate to personality and behavior differences in people with and without alcohol dependence. Eligibility: - Adults age 18 and older. Design: - Participants will visit the NIH Clinical Center once during the study. - Participants will be screened with a medical history, EKG, and physical exam. They will give blood and urine samples and undergo a psychiatric interview. - Participants will be asked about their alcohol drinking, to see if they have an alcohol use disorder. - Participants will play three computerized games. Some will play these games inside a magnetic resonance imaging (MRI) scanner. - MRI: strong magnetic field and radio waves take pictures of the brain. Participants lie on a table that slides in and out of a cylinder. They will be in the scanner for about 90 minutes. They may lie still for up to 20 minutes at a time. The scanner makes loud knocking noises. They will get earplugs. Type: Observational Start Date: Jul 2014 |
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Familial Mediterranean Fever and Related Disorders: Genetics and Disease Characteristics
National Human Genome Research Institute (NHGRI)
Familial Mediterranean Fever (FMF)
Autoinflammation
Periodic Fever
Fever
Genetic Diseases
This study is designed to explore the genetics and pathophysiology of diseases presenting
with intermittent fever, including familial Mediterranean fever, TRAPS, hyper-IgD
syndrome, and related diseases.
The following individuals may be eligible for this natural history study: 1) patients
with kno1 expand
This study is designed to explore the genetics and pathophysiology of diseases presenting with intermittent fever, including familial Mediterranean fever, TRAPS, hyper-IgD syndrome, and related diseases. The following individuals may be eligible for this natural history study: 1) patients with known or suspected familial Mediterranean fever, TRAPS, hyper-IgD syndrome or related disorders; 2) relatives of these patients; 3) healthy, normal volunteers 7 years of age or older. Patients will undergo a medical and family history, physical examination, blood and urine tests. Additional tests and procedures may include the following: 1. X-rays 2. Consultations with specialists 3. DNA sample collection (blood or saliva sample) for genetic studies. These might include studies of specific genes, or more complete sequencing of the genome. 4. Additional blood samples a maximum of 1 pint (450 ml) during a 6-week period for studies of white cell adhesion (stickiness) 5. Leukapheresis for collecting larger amounts of white cells for study. For this procedure, whole blood is collected through a needle in an arm vein. The blood flows through a machine that separates it into its components. The white cells are removed and the rest of the blood is returned to the body through another needle in the other arm. Patients may be followed approximately every 6 months to monitor symptoms, adjust medicine dosages, and undergo routine blood and urine tests. They will receive genetic counseling by the study team on the risk of having affected children and be advised of treatment options. Participating relatives will undergo a medical and family history, possibly with a review of medical records, physical examination, blood and urine tests. Additional procedures may include a 24-hour urine collection, X-rays, and consultations with medical specialists. A DNA sample (blood or saliva) will also be collected for genetic studies. Additional blood samples of no more than 550 mL during an 8-week period may be requested for studies of white cell adhesion (stickiness). Relatives who have familial Mediterranean fever, TRAPS, or hyper-IgD syndrome will receive the same follow-up and counseling as described for patients above. Normal volunteers and patients with gout will have a brief health interview and check of vital signs (blood pressure and pulse) and will provide a blood sample (up to 90 ml, or 6 tablespoons). Additional blood samples of no more than 1 pint over a 6-week period may be requested in the future.... Type: Observational Start Date: Mar 1994 |
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Characterization of Nociception Phenotype in Individuals With Intellectual Disability
National Institutes of Health Clinical Center (CC)
Intellectual Disability
Background:
People with intellectual disability (ID) often have physical disabilities as well. These
physical problems can affect their bones, muscles, nerves, and gastrointestinal tracts.
All of these issues can also cause pain. Yet little research has been done on pain in
people with ID.
Object1 expand
Background: People with intellectual disability (ID) often have physical disabilities as well. These physical problems can affect their bones, muscles, nerves, and gastrointestinal tracts. All of these issues can also cause pain. Yet little research has been done on pain in people with ID. Objective: To compare brain responses to unpleasant stimuli in people with and without ID. Eligibility: People aged 8 to 30 years diagnosed with an ID. Healthy volunteers without an ID are also needed. Design: The study requires only 1 visit of up to 4 hours. Participants with ID may come for up to 5 shorter visits instead. Participants will take a test to measure their level of ID. They will have a physical exam. Both groups will answer questions about pain and how their bodies react to it. They will answer questions about how they respond to things they see, feel, hear, smell, and taste. They will answer questions about their social behaviors. Caregivers may answer questions if the participant cannot. Both groups will have a test to measure their brain activity. Participants will wear a special cap, like a swim cap, with sensors and wires. Sensors to examine the heart will be placed on the skin of their chest with stickers. An elastic band will be placed around the middle of their body to measure how fast they are breathing. Sensors to measure sweat will be placed on two fingers. Participants will have heat, cold, brushing, and mild electrical stimuli to different parts of their body. Participants will rank how each stimulus feels using a scale with numbers or a scale with faces. Type: Interventional Start Date: Mar 2026 |
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Development of Patient-Reported Outcome Measures Assessing Tumor Visibility and Appearance Concerns1
National Cancer Institute (NCI)
Neurofibromatosis Type 1
Neurofibroma
Background:
Neurofibromatosis 1 (NF1) is a disease that causes tumors to grow along the nerves. These
include plexiform neurofibromas (pNF) and cutaneous neurofibromas (cNF). Both pNF and cNF
can be visible to other people. These tumors can affect a person s appearance and quality
of life. Researc1 expand
Background: Neurofibromatosis 1 (NF1) is a disease that causes tumors to grow along the nerves. These include plexiform neurofibromas (pNF) and cutaneous neurofibromas (cNF). Both pNF and cNF can be visible to other people. These tumors can affect a person s appearance and quality of life. Researchers want to be able to assess changes in appearance before and after treatment for NF1 tumors. Objective: To see if two questionnaires can help assess people s ratings about the appearance of their pNF and cNF tumors. Eligibility: People aged 8 years and older with pNF and people 12 years and older either with cNF or both pNF and cNF. Adult caregivers of children with pNF and cNF are also needed. Design: Participants will complete questionnaires on paper or by phone, computer, or tablet. They will answer questions about how they look, how they feel, and how they feel about the way they look. Participants will meet in at least 1 remote focus group or individual interview. The meeting will last about 1 hour. Each group will include 3 to 5 people, organized by age: 8 to 11 years, 12 to 17 years, 18 to 29 years, and over 30 years. Adult caregivers will meet in a group with other caregivers. They will discuss their NF1 symptoms; how their tumors look; how they feel about the way their tumors look; and their daily activities. They will give their opinions about 2 questionnaires about appearance. The group and individual meetings will be audio-recorded and transcribed. Information that can reveal individual identities will be removed. Type: Observational Start Date: Apr 2025 |
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GPC3 Targeted CAR-T Cell Therapy in Advanced GPC3 Expressing Solid Tumor Malignancies
National Cancer Institute (NCI)
Hepatocellular Carcinoma
Hepatocellular Cancer
Metastatic Hepatocellular Carcinoma
Background:
A new cancer treatment takes a person s own T cells, modifies them in a laboratory so
they can better fight cancer cells, and then gives them back to the person. Researchers
want to see if this treatment can help people with a certain types of cancer.
Objective:
To see if a personali1 expand
Background: A new cancer treatment takes a person s own T cells, modifies them in a laboratory so they can better fight cancer cells, and then gives them back to the person. Researchers want to see if this treatment can help people with a certain types of cancer. Objective: To see if a personalized immune treatment, anti-GPC3 CAR-T cells, is safe. Eligibility: Adults aged 18 years and older who have Glypican-3 (GPC3) positive solid tumor malignancy. Design: Participants will be screened with the following: Blood and urine tests Medical history Physical exam Heart function tests Review of their symptoms and their ability to perform their normal activities Tumor biopsy Imaging scan of the chest, abdomen, and pelvis Participants will have leukapheresis. They may have an IV (intravenous catheter, a small tube put into an arm vein) inserted into each arm or get a central line. Blood will be removed. A machine will separate the white blood cells from their blood. The rest of their blood will be returned to them. Participants will be admitted to the hospital for about 2 weeks. They will get the chemotherapy drugs fludarabine and cyclophosphamide by IV for 3 days. Then they will receive the modified white blood cells by IV. Participants will have frequent blood draws. They will give blood and tumor samples for research. Participants will have follow-up visits for the next 15 years. Then they will be contacted by email or phone for the rest of their life. If their disease does not get worse after 5 years, they will continue to be invited to do imaging studies every 6 months. Type: Interventional Start Date: Dec 2021 |
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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 and their relatio1 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, EKG and blood and urine tests. - Participants will have 3-day visits. They will return every 2 years. - All visits include: - Blood and urine collection - Physical performance tests - Health questionnaires - Memory and problem-solving tests - Magnetic Resonance Imaging (MRI) and Computerized Tomography (CT) scans. - Muscle metabolism/ exercise tests - Taste strips - Muscle and/or skin biopsies/ red light therapy - Retinal imaging/ eye tracking - Sleep study - ODD visits also include: - Cytapheresis - Bone marrow aspirate - EVEN visits also include: - Hyperglycemic CLAMP - Lumbar Puncture (LP) - Continuous Glucose Monitor (CGM) Type: Observational Start Date: Mar 2015 |
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Collection and Distribution of Blood Components From Healthy Donors for In Vitro Research Use
National Institutes of Health Clinical Center (CC)
Blood Donors
Research Subjects
Apheresis
This protocol is designed to provide a mechanism for the Department of Transfusion
Medicine, Clinical Center to collect and process blood components from paid, healthy
volunteer donors for distribution to NIH intramural investigators and FDA researchers for
in vitro laboratory use. Donors meeting r1 expand
This protocol is designed to provide a mechanism for the Department of Transfusion Medicine, Clinical Center to collect and process blood components from paid, healthy volunteer donors for distribution to NIH intramural investigators and FDA researchers for in vitro laboratory use. Donors meeting research donor eligibility criteria will be recruited to donate blood and blood components by standard phlebotomy and apheresis techniques. The investigational nature of the studies in which their blood will be used, and the risks and discomforts of the donation process will be carefully explained to the donors, and a signed informed consent document will be obtained. Donors will be compensated according to an established schedule based on the duration and discomfort of the donation. NIH and FDA investigators requesting blood components for research use will be required to submit an electronic (Web-based) memo of request, briefly describing the nature of the research, and providing assurance that samples provided through this protocol will be used solely for in vitro and not for in vivo research. This protocol also provides a detailed schema for careful and frequent laboratory safety monitoring of repeat research apheresis donors. Blood components for research use will be distributed with a unique product number, and the DTM principal and associate investigators will serve as the custodians of the code that links the product with a donor s identity. The nature of the in vitro studies in which the blood and components collected in this study will be used is not the subject of this protocol, and is not possible to describe, since it involves basic investigative efforts in greater than 170 different NIH and FDA laboratories. The intent of this protocol is not to approve the research itself, but to provide adequate and complete informed consent for the donor, and to assure that the education, counseling, and protection of the study subjects (research blood donors) is performed in accordance with IRB, OHSR, OPRR and other applicable Federal regulatory standards Type: Observational Start Date: Jan 2001 |
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Study of the Disease Process of Lymphangioleiomyomatosis
National Heart, Lung, and Blood Institute (NHLBI)
Lung Disease
Pneumothorax
Tuberous Sclerosis
Lymphangioleiomyomatosis
Pulmonary lymphangioleiomyomatosis (LAM) is a destructive lung disease typically
affecting women of childbearing age. Currently, there is no effective therapy for the
disease and the prognosis is poor.
This study is designed to determine the disease processes involved at the level of cells
and mol1 expand
Pulmonary lymphangioleiomyomatosis (LAM) is a destructive lung disease typically affecting women of childbearing age. Currently, there is no effective therapy for the disease and the prognosis is poor. This study is designed to determine the disease processes involved at the level of cells and molecules, in order to develop more effective therapy. Researchers intend to identify the proteins and genes that contribute to the process of lung destruction in affected individuals. Type: Observational Start Date: Dec 1995 |
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A Study of Ivonescimab in Combination With Dato-DXd or Osimertinib in People With Non-Small Cell Lu1
Memorial Sloan Kettering Cancer Center
Non-Small Cell Lung Cancer
The researchers are doing this study to find out whether ivonescimab in combination with
datopotamab deruxtecan- (Dato-DXd) or osimertinib are safe and effective treatments in
people with non-small cell lung cancer (NSCLC) that has an EGFR mutation. We will test
different doses of the Dato-DXd or o1 expand
The researchers are doing this study to find out whether ivonescimab in combination with datopotamab deruxtecan- (Dato-DXd) or osimertinib are safe and effective treatments in people with non-small cell lung cancer (NSCLC) that has an EGFR mutation. We will test different doses of the Dato-DXd or osimertinib with an unchanging (fixed) dose of ivonescimab to find the best dose that causes few or mild side effects in participants. Once the dose is found the researchers will test ivonescimab with Dato-DXd or osimertinib in a new group of participants to see if it is effective in treating their NSCLC with an EGFR mutation. Type: Interventional Start Date: Apr 2026 |
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Acute Amino Acid Response of Proprietary Beverages
Shaklee Corporation
Healthy
The primary objective of this study is to evaluate post-meal amino acid in response to a
proprietary beverages in generally healthy adults. expand
The primary objective of this study is to evaluate post-meal amino acid in response to a proprietary beverages in generally healthy adults. Type: Interventional Start Date: Apr 2026 |
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Implementing AI-Assisted, Patient-Friendly Imaging Report Summaries to Enhance Oncology Care Delive1
University of Wisconsin, Madison
Oncology
The implementation of the AI-assisted radiology summary tool into clinical workflows is
being conducted as part of a standard-of-care quality improvement (QI) initiative at UW
Health. The evaluation of this tool's impact via structured feedback from patients and
providers is being undertaken as a p1 expand
The implementation of the AI-assisted radiology summary tool into clinical workflows is being conducted as part of a standard-of-care quality improvement (QI) initiative at UW Health. The evaluation of this tool's impact via structured feedback from patients and providers is being undertaken as a prospective research study. Type: Observational Start Date: Feb 2026 |
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Radioembolization Versus External Radiation Therapy
Henry Ford Health System
Heptocellular Cancer
The proposed study is a single site, prospective, randomized phase 2 study to evaluate
the efficacy and tolerability transarterial radioembolization (TARE) versus stereotactic
body radiation therapy (SBRT) for hepatocellular carcinoma. The SBRT arm of the trial
will involve standard SBRT delivered1 expand
The proposed study is a single site, prospective, randomized phase 2 study to evaluate the efficacy and tolerability transarterial radioembolization (TARE) versus stereotactic body radiation therapy (SBRT) for hepatocellular carcinoma. The SBRT arm of the trial will involve standard SBRT delivered over 3-5 fractions as tolerated with dose/total therapy adjusted as needed for safety. The TARE arm of the trial will involve a planning arteriogram followed by selective transarterial delivery of Yttrium-90 into the segmental (≤2) artery supplying the tumor. Administered activity will be an amount prescribed to deliver a dose ≥200 Gy to the perfused tissue. The primary endpoint is the rate of re-treatment of the index lesion over 12 months. Type: Interventional Start Date: Dec 2025 |
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ACT Group for Stroke Caregivers
The Wright Institute
Caregiver Stress
Caregiver Stress Syndrome
Caregiver Burnout
Caregiver Distress
Caregiver Exhaustion
The goal of this study is to evaluate the efficacy of group-based ACT intervention in
improving the levels of psychological distress in caregivers of stroke survivors. The
main questions it aims to answer are:
1. Does group-based ACT intervention improve the levels of psychological distress and1 expand
The goal of this study is to evaluate the efficacy of group-based ACT intervention in improving the levels of psychological distress in caregivers of stroke survivors. The main questions it aims to answer are: 1. Does group-based ACT intervention improve the levels of psychological distress and QoL in family caregivers of stroke survivors? 2. Do the levels of psychological flexibility and experiential avoidance in family caregivers of stroke survivors mediate the outcome of the ACT Group? The researcher will compare the experimental group (i.e., participants who received group-based ACT intervention) with the control group (i.e., participants who did not receive group-based ACT intervention) to assess whether the group-based ACT intervention is effective in mitigating caregiver stress and improving caregivers' QoL. Participants in the experimental group will: 1. Receive a 5-weekly, 1.5-hour group intervention based on the ACT Model; 2. Complete study measures at pre-treatment, immediate post-treatment, and 2-month follow-up. Participants in the control group will not receive the group intervention but will complete the same study measures. Type: Interventional Start Date: Sep 2025 |
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A Study Of Exercise In Patients With Spontaneous Coronary Artery Dissection And Fibromuscular Dyspl1
Mayo Clinic
Fibromuscular Dysplasia
Spontaneous Coronary Artery Dissection
The purpose of this study is to assess the cardiopulmonary, hemodynamic, and symptom
responses to acute bouts of varying intensity aerobic and resistance exercise in people
with Spontaneous Coronary Artery Dissection (SCAD) and/or Fibromuscular Dysplasia (FMD). expand
The purpose of this study is to assess the cardiopulmonary, hemodynamic, and symptom responses to acute bouts of varying intensity aerobic and resistance exercise in people with Spontaneous Coronary Artery Dissection (SCAD) and/or Fibromuscular Dysplasia (FMD). Type: Interventional Start Date: Apr 2026 |
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Brain Stimulation and Cognitive Training for MCI
Medical University of South Carolina
Mild Cognitive Impairment (MCI)
Mild Neurocognitive Disorder
Neurocognitive Disorders
Cognitive Dysfunction
Cognition Disorders
This is a randomized clinical trial of a treatment that combines non-invasive brain
stimulation with computerized cognitive training (CCT) for people with mild cognitive
impairment (MCI). The form of brain stimulation used in this study is accelerated
intermittent theta burst stimulation (iTBS). Al1 expand
This is a randomized clinical trial of a treatment that combines non-invasive brain stimulation with computerized cognitive training (CCT) for people with mild cognitive impairment (MCI). The form of brain stimulation used in this study is accelerated intermittent theta burst stimulation (iTBS). All participants receive the same amount of iTBS and are randomly assigned to engage in one of two types of CCT. The goals of the study are to see if this combined treatment is feasible and acceptable to people with MCI and whether combined iTBS and CCT improves memory, thinking skills, mood, and daily function. Type: Interventional Start Date: Mar 2026 |