
Search Clinical Trials
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Caregiving Networks Across Disease Context and the Life Course
National Human Genome Research Institute (NHGRI)
Inherited Metabolic Disorders
Undiagnosed Diseases
Batten's Disease
Tay Sachs
Diabetes
Background:
In the U.S., about 53 million informal, unpaid caregivers provide care to a person who is
ill, is disabled, or has age-related loss of function. These caregivers may be adult
children, spouses, parents, or others. The stress of providing long-term care affects
caregivers health and wel1 expand
Background: In the U.S., about 53 million informal, unpaid caregivers provide care to a person who is ill, is disabled, or has age-related loss of function. These caregivers may be adult children, spouses, parents, or others. The stress of providing long-term care affects caregivers health and well-being. Researchers want to learn more about this stress and its effects. Objective: To learn how the caregiving process affects the health and well-being of caregivers over time. Eligibility: Adults aged 18 years and older who are caregivers for a person with a chronic medical condition and who have already given consent to take part in other study activities. Design: Participants will be put in different groups. They will complete some or all of the following tasks over 1 year. They may repeat these tasks once a year for up to 5 years. Participants will fill out 2 online surveys. One will ask about their health and their caregiving experience. The other will ask them to list people in their social network and their care recipient s social network who give them support. Participants will have a 2-part phone interview. It will be audio recorded. In part 1, they will be asked about the people they listed in the survey. In part 2, they will be asked about their caregiving experience and events in the care recipient s life. Participants may fill out a weeklong diary every 3 months. It will ask about their daily social activities, well-being, and stress levels. It will also ask about their thoughts and feelings about caregiving. Participants may give a blood sample each year they are in the study. ... Type: Observational Start Date: Sep 2022 |
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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: Jun 2026 |
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Lurbinectedin With or Without Avelumab in Small Cell Carcinoma of the Bladder (LASER)
National Cancer Institute (NCI)
Small Cell Carcinoma of the Bladder
High Grade Neuroendocrine Tumors of the Urinary Tract
Background:
Small cell carcinoma of the bladder (SCCB) and other high-grade neuroendocrine tumors
(HGNET) of the urinary tract are rare but aggressive cancers. Average survival for people
diagnosed with SCCB or HGNET is about 1 year. Lurbinectedin and avelumab are drugs that
are approved to treat1 expand
Background: Small cell carcinoma of the bladder (SCCB) and other high-grade neuroendocrine tumors (HGNET) of the urinary tract are rare but aggressive cancers. Average survival for people diagnosed with SCCB or HGNET is about 1 year. Lurbinectedin and avelumab are drugs that are approved to treat other cancers. Researchers want to see if these drugs can help people with SCCB or HGNET. Objective: To test lurbinectedin with or without avelumab in people with SCCB or HGNET. Eligibility: Adults aged 18 years and older with SCBB or HGNET that returned and spread after treatment. Design: Participants will be screened. They will have a physical exam. They will have blood tests and imaging scans. They may need to have a new biopsy: A small needle will be used to collect a tissue sample from the tumor. Both study drugs are given through a tube attached to a needle inserted into a vein. If participants have already received a drug like avelumab they will receive only lurbinectedin. If patients have not been previously treated with a drug like avelumab they will receive both lurbinectedin and avelumab. All participants will receive their treatment once every 3 weeks for up to 10 years. They will also receive other drugs to relieve adverse effects. Biopsies, blood tests, and imaging scans will be repeated during some study visits. Participants may also have urine tests and tests of their heart function. Participants may remain in the study as long as the treatment is helping them. If they stop treatment, they will have safety visits 14, 30, and 90 days after their last dose. Additional follow-up visits will continue 5 to 10 years. Type: Interventional Start Date: Jun 2024 |
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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)
Progressive Multifocal Leukoencephalopathy
Multiple Sclerosis
Other Neuroinflammatory Diseases With BBB Leakage
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 |
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Donor Lymphocyte Infusion After Allogeneic Hematopoietic Cell Transplantation for High-Risk Hematol1
National Cancer Institute (NCI)
Hematologic Neoplasms
Background:
People with blood cancers often receive blood or bone marrow transplants. But even with
these treatments, the risk of relapse is high. Researchers want to see if giving the
transplant recipient an infusion of lymphocytes (a type of white blood cell) from their
transplant donor early af1 expand
Background: People with blood cancers often receive blood or bone marrow transplants. But even with these treatments, the risk of relapse is high. Researchers want to see if giving the transplant recipient an infusion of lymphocytes (a type of white blood cell) from their transplant donor early after the transplant can reduce that risk. Objective: To learn if giving donor lymphocytes early after a transplant will help reduce the risk of relapse for people with certain blood cancers. Eligibility: Adults aged 18-65 with high-risk leukemia, lymphoma, myelodysplastic syndrome, or multiple myeloma that does not respond well to standard treatments and/or has a high risk of relapse. Healthy potential bone marrow and lymphocyte donor relatives aged 12 and older are also needed. Design: Participants will be screened with: Physical exam Blood and urine tests Spinal tap Eye exam Dental exam Heart and lung tests Imaging scans. A radioactive substance may be injected in their arm if a PET scan is needed. Bone marrow aspiration and biopsy Some screening tests will be repeated during the study. Participants will stay at the NIH hospital for about 4 weeks. They will receive a central venous catheter. They will get chemotherapy and other drugs starting 6 days before transplant. Then they will have their transplant. They will receive donor white blood cells 7 days later. They will give blood, bone marrow, urine, and stool samples for research. They must stay near NIH for at least 100 days after transplant. Participants will have periodic follow-up visits for 5 years. Healthy donors will have 2-3 visits. They will give blood, bone marrow, white blood cells, and stool samples for research. Participation will last for 5 years.... Type: Interventional Start Date: May 2022 |
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Biochemical and Phenotypical Aspects of Smith-Lemli-Opitz Syndrome and Related Disorders of Cholest1
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Smith Lemli Opitz Syndrome
CHILD Syndrome
Lathosterolosis
Desmosterolosis
Background:
Smith-Lemli-Opitz Syndrome (SLOS) is a genetic disorder. It can cause birth defects and
developmental delays. There is no cure for SLOS or other inherited diseases related to
cholesterol production or storage. The data gained in this study may help researchers
find ways to measure how1 expand
Background: Smith-Lemli-Opitz Syndrome (SLOS) is a genetic disorder. It can cause birth defects and developmental delays. There is no cure for SLOS or other inherited diseases related to cholesterol production or storage. The data gained in this study may help researchers find ways to measure how well future treatments work. Objective: To learn more about SLOS and related disorders and how these diseases affect participants and relatives. Eligibility: People of any age who have or are suspected to have SLOS or another inherited disease related to cholesterol production or storage. Relatives are also needed. Design: Participants will be screened with a medical record review. Participants will have visits every 6 to 12 months. They will have a physical exam. They will fill out a survey about their medical and behavioral history. They may have an eye exam. They may have a neurodevelopmental assessment. They may have a hearing test. Their outer and middle ears may be examined. Their ability to speak, understand speech, eat, and swallow may be assessed. They may get X-rays while they chew and swallow. Their functional ability and needs for adaptive devices or braces may be assessed. They may have a lumbar puncture. Photographs may be taken of their face and body. Participants who cannot visit the NIH and relatives will have a virtual visit once a year. They will talk about their medical history and symptoms. They give blood, urine, and skin samples at a lab near their home. They will fill out a survey about their medical and behavioral history. Participation will last for several years. Type: Observational Start Date: Jun 2021 |
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Natural History Study of Patients With Excess Androgen
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Congenital Adrenal Hyperplasia (CAH)
Familial Male-Limited Precocious Puberty (FMPP)
This study will evaluate and gather information in patients with genetic causes of too
much androgen (male-like hormone) in order to better understand the effects of too much
androgen and describe problems associated with it. Too much androgen in childhood, if
untreated, results in rapid growth and1 expand
This study will evaluate and gather information in patients with genetic causes of too much androgen (male-like hormone) in order to better understand the effects of too much androgen and describe problems associated with it. Too much androgen in childhood, if untreated, results in rapid growth and early puberty with early cessation of growth and short stature in adulthood. Too much androgen in adulthood may result in infertility, and women may have excess facial hair, acne and a more male-like appearance. Excess androgen may also affect mood and behavior and possibly the secretion of other hormones, such as insulin. Two genetic diseases that result in early childhood androgen excess are congenital adrenal hyperplasia (CAH) and familial male-limited precocious puberty (FMPP). Patients with known or suspected CAH due to 21-hydroxylase deficiency, 11- hydroxylase deficiency, or 3-beta-hydroxysteroid dehydrogenase deficiency and males with known or suspected FMPP may be eligible for this study. Patients with both classic and non-classic CAH are eligible, and patients with androgen excess of unknown cause may be eligible. Participants undergo the following procedures: - Medical history and physical examination. - Fasting blood tests for analysis of hormones, blood chemistries including blood sugar and cardiovascular risk factors such as lipids. - Oral glucose tolerance test for patients with elevated insulin levels. For this test, a catheter (plastic tube) is placed in a vein in the patient's arm. The patient drinks a sugar-containing fluid and blood samples are collected through the catheter at intervals starting with drinking the solution, and then 30, 60 and 120 minutes after drinking the solution. - 24-hour urine collection to measure hormone levels in the urine. - DNA testing for patients with 21-hydroxylase deficiency to help identify the type of genetic mutation responsible for the disease. - X-ray of the left hand to measure bone age in growing children. The x-ray is used to determine how far into puberty the child is and how much growth potential is left in the bones. - A pelvic ultrasound in females and testicular ultrasound in males to evaluate the size and development of the gonads (ovaries in females and testes in males). - Cognitive and psychological tests, including an IQ test and evaluation of memory, achievement and behavior. - Other tests and evaluations based on medical need. The schedule for these procedures varies. In a part of the study involving only patients with CAH, growing children are evaluated twice (once in childhood and once after reaching adult height), and adults are evaluated once. In another part of the study involving patients with CAH and FMPP, growing children are seen twice a year, and adults and children who have reached adult height may be seen annually. Additional visits may be scheduled if medically indicated. In this part of the study, females are asked to keep a record of their periods after their first menstrual cycle. Type: Observational Start Date: Jan 2006 |
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Immune Profiling of CLL/SLL Treated With First-Line Pirtobrutinib
National Heart, Lung, and Blood Institute (NHLBI)
Chronic Lymphocytic Leukemia (CLL)
Small Lymphocytic Lymphoma (SLL)
Background:
Chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL) are blood cancers
that affect certain white blood cells. Advanced forms of these diseases are difficult to
treat. Pirtobrutinib is a drug approved to treat CLL and SLL after 2 previous treatments.
Researchers want1 expand
Background: Chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL) are blood cancers that affect certain white blood cells. Advanced forms of these diseases are difficult to treat. Pirtobrutinib is a drug approved to treat CLL and SLL after 2 previous treatments. Researchers want to know how this drug affects the immune system in those who have not yet started other treatments for CLL or SLL. Objective: To test pirtobrutinib as a first-line treatment for CLL or SLL. Eligibility: People aged 18 years and older with untreated CLL or SLL. Design: Participants will be screened. They will have a physical exam with blood tests. They will have imaging scans and tests of their heart function. They will have a lymph node biopsy: A large needle will be inserted into a lymph node to collect a small piece of tissue. Pirtobrutinib is a tablet taken by mouth. Participants will take 2 to 4 tablets daily in 4-week cycles. Participants will have clinic visits once every 4 weeks for the first 3 months. Then they will be seen once every 3 months. Imaging scans, lymph node biopsy, and other tests will be repeated at various study visits. A bone marrow biopsy (collection of soft tissue from inside a bone) may be done if there is no evidence of disease after 1 year of treatment with the study drug. Participants may opt to have cancer and immune cells collected from their blood. The cells will be used for research. Participants will have a clinic visit 1 month after their last dose of the study drug. Then they will have follow-up visits or phone calls every 6 to 12 months.... Type: Interventional Start Date: Mar 2026 |
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Characterization of Dysmorphology in Subjects With Creatine Transporter Deficiency
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Cognitive Disorder
Metabolic Disease
Autism Spectrum Disorder
Background:
Creatine transporter deficiency (CTD) is a genetic disorder that mainly affects the brain
in males. CTD causes intellectual disability that can be mild to severe. People with CTD
may have seizures and behavioral issues. They may have slow growth and tire easily. CTD
may sometimes be co1 expand
Background: Creatine transporter deficiency (CTD) is a genetic disorder that mainly affects the brain in males. CTD causes intellectual disability that can be mild to severe. People with CTD may have seizures and behavioral issues. They may have slow growth and tire easily. CTD may sometimes be confused with autism or other disorders. Better diagnostics are needed. The study team in an NIH study noted that the faces of children with CTD can look similar. For this natural history study, an expert will examine photos of children with CTD. Any shared traits found might help to diagnose CTD. Objective: To look for shared facial features of children with CTD. Eligibility: Males aged 2 to 40 years old with CTD who were in study 17-CH-0020. Design: Some participants in study 17-CH-0020 had pictures taken of their faces. The NIH study team wants to share these photos with a colleague in Canada. This person is an expert at evaluating how genetic disorders affect people s bodies. Participant data collected during the study may also be sent to this expert. This data may include diagnostic images and results from lab tests. Some children did not have their pictures taken during study 17-CH-0020. Parents are asked to take pictures of these children and send them to the study team. These photos can be sent to a secure portal. The photos can also be taken in-person during a clinic visit. The photos may be printed in clinical study journals. But this is not required. Parents will be asked to sign a separate consent before the photos are published.... Type: Observational Start Date: Oct 2022 |
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Evaluation of Patients With Gastrointestinal Disease
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Lower GI Disease
Gastrointestinal Diseases
Background:
Ongoing and future research projects that study gastrointestinal diseases depend on
access to biological samples and clinical data. Researchers want to study people who are
seen and treated for these diseases. This may help them assess and treat these diseases
better in the future.
Ob1 expand
Background: Ongoing and future research projects that study gastrointestinal diseases depend on access to biological samples and clinical data. Researchers want to study people who are seen and treated for these diseases. This may help them assess and treat these diseases better in the future. Objective: To collect data and samples from people being seen and/or treated for gastrointestinal problems at NIH, to use in future research. Eligibility: Adults aged 18 and older who have known or suspected gastrointestinal disorders or need screening, treatment, or follow-up per current medical guidelines. Design: Participants will be screened with a physical exam. Their medical records will be reviewed. Participants will be seen by doctors based on the ailment they have. Their condition will be treated just like it would at a doctor s office. But the data and samples collected will be used for future research. Participants may give blood, urine, and/or stool samples. If participants have an endoscopy or colonoscopy as part of their standard care and samples are taken, they may be asked to give their leftover samples to NIH. Or, they may be asked to have extra samples taken for NIH to use. These samples may include gastric acid and/or tissue from the lining of the stomach or intestines. If samples are not taken as part of their standard care, they may be asked to have samples taken for NIH to use. Data will be stored at NIH. The data systems are password protected. Samples will be coded. Participants will take part in the study for as long as they agree to be seen for their disease.... Type: Observational Start Date: Jan 2022 |
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Phase I Trial of TURALIO(R) (Pexidartinib, PLX3397) in Children and Young Adults With Refractory Le1
National Cancer Institute (NCI)
Neurofibroma, Plexiform
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Leukemia, Promyelocytic, Acute
Sarcoma
Background:
- Some people with cancer have solid tumors. Others have refractory leukemia. This may
not go away after treatment. Researchers want to see if a drug called TURALIO(R) can
shrink tumors or stop them from growing.
Objectives:
- To find the highest safe dose and side effects of TURALIO1 expand
Background: - Some people with cancer have solid tumors. Others have refractory leukemia. This may not go away after treatment. Researchers want to see if a drug called TURALIO(R) can shrink tumors or stop them from growing. Objectives: - To find the highest safe dose and side effects of TURALIO(R). To see if it helps treat certain types of cancer. Eligibility: - People ages 3-35 with a solid tumor or leukemia that has returned or not responded to cancer therapies. Design: - Individuals will be screened with: - Medical history - Physical exam - Blood and urine tests - Heart tests - Scans or other tests of the tumor - Individuals will take TURALIO(R) as a capsule once daily for a 28-day cycle. They can do this for up to 2 years. - During the study, participants will have many tests and procedures. They include repeats of the screening tests. Individuals will keep a diary of symptoms. - Individuals with solid tumors will have scans or x-rays. - Individuals with leukemia will have blood tests. They may have a bone marrow sample taken. - Some individuals may have a biopsy. - When finished taking TURALIO(R), individuals will have follow-up visits. They will repeat the screening tests and note side effects. Type: Interventional Start Date: Apr 2015 |
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Personalized Environment and Genes Study
National Institute of Environmental Health Sciences (NIEHS)
Diabetes
Heart Disease
Asthma
Despite the overwhelming focus on genetic and genomic causes of human disease over the
past two decades, it has been estimated that genetics is currently known to explain only
20% and 40% of the etiology of common disease. Thus, it is becoming increasingly apparent
that human disease is a consequen1 expand
Despite the overwhelming focus on genetic and genomic causes of human disease over the past two decades, it has been estimated that genetics is currently known to explain only 20% and 40% of the etiology of common disease. Thus, it is becoming increasingly apparent that human disease is a consequence of both genetic susceptibility and environmental exposures. Importantly, while individuals cannot change their genetic composition, we do have the ability both personally and as a society, to influence our environment, promoting health and decreasing the risk of disease. The Personalized Environment and Genes Study (PEGS) aims to determine how the environment and gene-environment interactions can inform our understanding of human health and disease. As science has evolved, so too has the science of this project. This evolution was reflected in a change in the title of this project from the Environmental Polymorphisms Registry (EPR) to the Personalized Environment and Genes Study (PEGS) to more accurately reflect the science that can be conducted. PEGS is a unique resource because of the depth of environmental phenotyping which includes extensive information from exposome surveys, as well as whole genome sequencing on a significant number of participants in the cohort. While it is small relative to genomic cohorts, none of these have the extensive environmental data that is present in PEGS. In addition, other cohorts with deep environmental data lack the depth of genomic data that is present in PEGS. Importantly, PEGS has already provided important analytic advances that are of great interest to and can be confirmed in larger cohorts such as All of Us. The Personalized Environment and Genes Study (PEGS) aims to provide a resource for environmental health translational research by examining gene-environment interactions in health and disease. PEGS is an extension of two previous efforts where it began as a pilot study, the Environmental Polymorphisms Study (EPS; IRB# 02E9004) and was approved subsequently as a full protocol titled the Environmental Polymorphisms Registry (EPR) (IRB #04-E-N0053 and transitioned to its current ID# 04-E-0053). The EPR was envisioned as a phenotype-by-genotype registry of participants who had donated DNA samples, and who had agreed to be contacted for follow-up clinical translational studies based on their DNA genotypes. At the time, the only information available was a participant s age, sex, race, and ethnicity. Further phenotyping of a participant and/or any biospecimens obtained were investigated during a follow-up translational clinical study on participants recruited based on their genotype (hence phenotype-by-genotype) and the PEGS was the first recruit-by- genotype study at the NIH. Following a period focused on recruiting approximately 15,000 participants to enable genotyping of rare (approximately 1% minor allele frequency) single nucleotide polymorphisms (SNPs), the PEGS Consortium Project was undertaken in 2010- 2011 to examine, using the DNA of nearly 4,000 participants, approximately 700 SNPs in approximately 80 environmental response genes that work in concert with environmental exposures to elicit a phenotype. Several clinical follow-up studies, genotype-phenotype association studies, and publications have resulted from the PEGS Consortium Project. To expand phenotype information available to researchers, the Health and Exposure Questionnaire was administered between 2013-2014. In 2017, a more detailed Exposome Questionnaire which includes questions relating to the external and internal exposome was administered. This was an important resource through which to integrate exposures with genotype-phenotype association studies. Whole genome sequencing has now been performed on approximately 4700 participants who were reconsented for this purpose, as indicated above. Questionnaire data was fully adjudicated and combined in a robust and searchable database. With the increased power of the data available, the project was renamed as the Personalized Environment and Genes Study (PEGS) and rolled out in Sept. 2021. Type: Observational Start Date: May 2010 |
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Detection and Characterization of Host Defense Defects
National Institute of Allergy and Infectious Diseases (NIAID)
Immune Defects
This protocol is designed to evaluate selected patients with documented recurrent or
unusual infections and their family members for clinical and laboratory correlates of
immune abnormalities. It allows long term follow up of patients with host defense defects
and permits the periodic study of thei1 expand
This protocol is designed to evaluate selected patients with documented recurrent or unusual infections and their family members for clinical and laboratory correlates of immune abnormalities. It allows long term follow up of patients with host defense defects and permits the periodic study of their blood, urine, saliva, skin, stool and vaginal specimens or wound drainage from such patients or their family members for medically indicated purposes and research studies related to understanding the genetic and biochemical bases of these diseases. This protocol may help provide patients and materials for the development of therapies for these diseases. This study will: 1. Determine the biochemical and genetic causes of inherited immune diseases affecting phagocytes (white blood cells that defend against bacterial and fungal infections) 2. Try to develop better ways to diagnose and treat patients with these diseases, and to prevent, diagnose and treat their infections Patients and family members may undergo the following procedures: - A personal and family medical history, physical examination and other procedures, which may include various blood tests; urinalysis; saliva collection; imaging studies such as chest X-ray, computed tomography (CT) or magnetic resonance imaging (MRI); and lung function studies, dental examination or eye examinations, if medically indicated. - Patients who have draining wounds will have fluid collected from these wounds for biochemical study. - Tissues removed as part of medical care, such as pieces of lung, liver, or teeth, or biopsies of these tissues will be studied. - Patients who have an immune problem that investigators wish to study further will be asked to return to NIH for follow-up visits at irregular intervals, but at least every 6 months. The visits will include an updated medical history, examination directed at the particular medical problem related to the immune disorder, follow-up of abnormal tests or treatment, and collection of blood, saliva, urine, or wound fluid for study. - Patients may have genetic testing and must be willing to have specimens stored for future research. - Family members will have a medical history, saliva or urine collection, and chest X-ray or other imaging study, if medically indicated. - Normal volunteers who have had tissue biopsies or pieces of tissue removed as part of medical care, such as pieces of lung, liver, or teeth, will have these tissues studied. - NIH does not cover the cost of the initial screening visit for travel or lodging. A financial assessment may determine if the patient is eligible for financial assistance. This study does not enroll children under the age of 2. - Patients will be asked to obtain their medical records, previous test results, or imaging studies prior to the first visit. Type: Observational Start Date: Sep 1993 |
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Prospective Investigation of Cirrhotic Cardiomyopathy in Humans
Vanderbilt University Medical Center
Cirrhotic Cardiomyopathy
Cirrhotic Cardiomyopathy (CCM) is a recognized complication of cirrhosis, but
understudied despite recent retrospective data suggesting it may be common, affecting one
in three patients with decompensated cirrhosis, and associated with significantly
increased risk of death and adverse hepatic and c1 expand
Cirrhotic Cardiomyopathy (CCM) is a recognized complication of cirrhosis, but understudied despite recent retrospective data suggesting it may be common, affecting one in three patients with decompensated cirrhosis, and associated with significantly increased risk of death and adverse hepatic and cardiac events. Moreover, evidence from preclinical models and children suggest elevated bile acids in the blood may contribute to CCM, but data from adults with cirrhosis are scarce. Therefore, we are conducting the first contemporary prospective multi-center investigation of CCM in adults in the USA to define CCM risk factors and impact on outcomes while deepening understanding of the role of bile acids in development of this disease. Type: Observational Start Date: Jan 2026 |
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Outcomes Associated With Tirbanibulin for Large Field Application on the Face in the U.S (CLEAR)
Avant Health LLC
Actinic Keratosis (AK)
The goal of this observational study is to learn about the effectiveness of tirbanibulin
among adult subjects with actinic keratosis (AK) lesions in the face. The main question
it aim to answer is:
How does tirbanibulin improve subject's overall appearance of the skin, improve how
patient's skin l1 expand
The goal of this observational study is to learn about the effectiveness of tirbanibulin among adult subjects with actinic keratosis (AK) lesions in the face. The main question it aim to answer is: How does tirbanibulin improve subject's overall appearance of the skin, improve how patient's skin looks, and improve patient's skin texture, in a 57-day observation period. Participants already taking tirbanibulin as part of their regular medical care for AK will answer online survey questions at the beginning of the study and at Day 57. Type: Observational Start Date: Apr 2026 |
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Comparison of Immediate Changes in Cervical Range of Motion Following Cervical Extension and Downsl1
Missouri State University
Cervical Disease
The purpose of this study is to compare the efficacy seated cervical extension glides vs
supine downslip glides, on both cervical rotation range of motion and patient comfort.
Information gathered from this study may be used to help clinicians determine the most
beneficial methods of cervical mobil1 expand
The purpose of this study is to compare the efficacy seated cervical extension glides vs supine downslip glides, on both cervical rotation range of motion and patient comfort. Information gathered from this study may be used to help clinicians determine the most beneficial methods of cervical mobilizations as a rehabilitation tool. Type: Interventional Start Date: Jun 2026 |
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Pilot Study of a Behavioral Program for Resident Depression in Skilled Nursing Facilities
Massachusetts General Hospital
Nursing Home Resident
Skilled Nursing Facility
Depression
Feasibility Studies
The goal of this clinical trial is to test a behavioral health program (Interventions for
Stressful Transitions in Later Life, InSTILL, for Individuals) for skilled nursing
facility residents. The main questions it aims to answer is whether the program is
program is feasible, satisfactory, and help1 expand
The goal of this clinical trial is to test a behavioral health program (Interventions for Stressful Transitions in Later Life, InSTILL, for Individuals) for skilled nursing facility residents. The main questions it aims to answer is whether the program is program is feasible, satisfactory, and helpful. Participants will join 6 bi-weekly sessions of the InSTILL program. Participants will complete assessments at three timepoints (all) and a brief-exit interview. Type: Interventional Start Date: Nov 2025 |
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Safety and Serum Virus Neutralizing Antibody Responses of VYD2311, a COVID-19 Vaccine, and Coadmini1
Invivyd, Inc.
COVID-19
The main purposes of this research study are to measure the safety (whether it causes any
side effects), tolerability (if it does cause any side effects, how well your body is
able to handle them), and reactions, both local at the injection site and systemic, that
may occur in the body after receiv1 expand
The main purposes of this research study are to measure the safety (whether it causes any side effects), tolerability (if it does cause any side effects, how well your body is able to handle them), and reactions, both local at the injection site and systemic, that may occur in the body after receiving VYD2311, or a COVID-19 vaccine, or a combination of VYD2311 and a COVID-19 vaccine in healthy participants. This research study will measure the amount of serum virus neutralizing antibodies produced in the blood (antibodies that block a virus from infecting cells) and pharmacokinetics of VYD2311 compared to a COVID-19 vaccine, when each is administered alone or concurrently. Pharmacokinetics is the study of how a drug moves through the body, including how it is absorbed (taken into the body), distributed (spread throughout the body), metabolized (broken down in the body), and eliminated (removed from the body), and how the body affects the drug. Type: Interventional Start Date: Jun 2026 |
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Using Light Therapy for Mild Cognitive Impairment
University of Oklahoma
Mild Cognitive Impairment (MCI)
Amyloid Pathology
The goal of this clinical trial is to test whether transcranial photobiomodulation
(tPBM), a non-invasive brain stimulation technique using near-infrared light, can improve
brain blood flow regulation (neurovascular coupling) and cognitive function in people
with mild cognitive impairment (MCI). Th1 expand
The goal of this clinical trial is to test whether transcranial photobiomodulation (tPBM), a non-invasive brain stimulation technique using near-infrared light, can improve brain blood flow regulation (neurovascular coupling) and cognitive function in people with mild cognitive impairment (MCI). The main questions it aims to answer are: - Does tPBM enhance cognitive function and cerebral hemodynamic responses during memory and finger tapping tasks? - Does tPBM reduce oxidative stress, inflammation, and mitigate brain cell damage? - Is cognitive improvement linked to amyloid status, greater cerebral hemodynamic response, and lower levels of brain inflammation and oxidative stress? Researchers will compare an active tPBM treatment arm to a sham treatment arm to see if tPBM leads to measurable improvements in brain activity and cognitive function compared to no active stimulation. Participants will: - Receive a 20-minute-long active tPBM or sham stimulation session once per day, 6 times per week, for 12 weeks. - Complete questionnaires and an iPad-based cognitive testing protocol. - Complete memory and motor tasks while their brain activity is measured using non-invasive techniques: simultaneous functional near-infrared spectroscopy (fNIRS) and electroencephalography (EEG). Dynamic analysis of the vessels in the eye will also be performed based on eligibility. Transcranial Doppler (TCD) flowmetry is optionally performed. - Provide blood samples to test for biomarkers of inflammation, oxidative stress, and brain cell damage. Type: Interventional Start Date: Oct 2025 |
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Patient-Centered Practical Vaccine Talk For Busy Clinicians
University of Massachusetts, Worcester
Influenza
COVID-19
The goal of this study is to assess the effect of an educational intervention for primary
care providers (PCPs) on influenza and COVID-19 vaccine uptake among their adult patients
through a pragmatic, cluster randomized trial in primary care clinics. expand
The goal of this study is to assess the effect of an educational intervention for primary care providers (PCPs) on influenza and COVID-19 vaccine uptake among their adult patients through a pragmatic, cluster randomized trial in primary care clinics. Type: Interventional Start Date: Jul 2026 |
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The Primary Objective of the Study is to Compare Eye Dryness Following LASIK (Laser-Assisted In Sit1
Vance Thompson Vision
Dry Eye Syndrome (DES)
Dry Eye Disease (DED)
Compare eye dryness following laser-assisted in situ keratomileusis (LASIK) surgery to
eye dryness prior to receiving perioperative Miebo in patients with dry eye disease (DED) expand
Compare eye dryness following laser-assisted in situ keratomileusis (LASIK) surgery to eye dryness prior to receiving perioperative Miebo in patients with dry eye disease (DED) Type: Interventional Start Date: May 2026 |
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Stimulating the Aging Brain Using Brain and Sensory Stimulation
Medical College of Wisconsin
Primary Progressive Aphasia
The goal of this project is to investigate whether transcranial electrical stimulation
and sensory stimulation affect language outcomes in individuals with primary progressive
aphasia (PPA). The main questions it aims to answer are:
Does transcranial alternating current stimulation (tACS) affect v1 expand
The goal of this project is to investigate whether transcranial electrical stimulation and sensory stimulation affect language outcomes in individuals with primary progressive aphasia (PPA). The main questions it aims to answer are: Does transcranial alternating current stimulation (tACS) affect verbal short-term memory (STM) in individuals with PPA? Does a single session of multisensory stimulation affect verbal STM in individuals with PPA? Researchers will compare active tACS to sham tACS (a fake stimulation condition) to see if active tACS improves verbal STM. Researchers will compare pre-multisensory stimulation to post-stimulation performance to see if multisensory stimulation improves verbal STM. Participants will: Undergo EEG, MRI (anatomical and functional) May complete a cognitive exam Undergo tACS over 3 separate sessions Undergo multisensory stimulation Complete language tasks before, during and/or after stimulation Type: Interventional Start Date: Jun 2026 |
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Method Comparison of Intelligent Fingerprinting Drug Screening System
Intelligent Bio Solutions Inc.
In Vitro Diagnostic Device
Prospective, multi-site, open-label, single- or double-dose, randomized, multi-site
performance evaluation of accuracy of the Intelligent Fingerprinting Drug Screening
System in the hands of intended users: "operators" and "donors." expand
Prospective, multi-site, open-label, single- or double-dose, randomized, multi-site performance evaluation of accuracy of the Intelligent Fingerprinting Drug Screening System in the hands of intended users: "operators" and "donors." Type: Observational Start Date: Jun 2026 |
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Nicotinamide Riboside, Vit B3 Analogue, and Brain Energy Metabolism
Massachusetts General Hospital
Healthy Adult
The goal of this clinical trial is to learn how nicotinamide riboside (NR), a form of
vitamin B3, affects brain energy metabolism in healthy adults. Researchers want to find
out if taking NR by mouth for 2 weeks can raise the balance of two related brain
chemicals called NAD+ and NADH, which play a1 expand
The goal of this clinical trial is to learn how nicotinamide riboside (NR), a form of vitamin B3, affects brain energy metabolism in healthy adults. Researchers want to find out if taking NR by mouth for 2 weeks can raise the balance of two related brain chemicals called NAD+ and NADH, which play a key role in how cells make and use energy. The main questions are: Does short term NR treatment increase the NAD+ to NADH ratio in the brain, and does it change other brain energy measures that we can see with a special type of MRI scan called phosphorus 31 MR spectroscopy. Adults between 18 and 65 years old who are generally healthy and do not have a personal or close family history of mood or psychotic disorders may be able to take part. People who join the study will first have a screening visit with a psychiatric interview and safety checks to confirm they are eligible and to review the risks and procedures. Eligible participants will then have a baseline visit that includes a blood draw, vital signs, urine drug and pregnancy tests when needed, and a 7 Tesla MRI/MRS scan focused on brain chemistry and structure. After the baseline visit, participants will take NR capsules by mouth at home, 1500 milligrams in the morning and 1500 milligrams in the early afternoon each day, for about 2 weeks, for a total daily dose of 3000 milligrams. They will be asked to avoid alcohol and other drugs during the study and to complete a short food diary near the end of the dosing period so that researchers can track diet. On the last day of taking NR, participants will return for repeat MRI/MRS scans, blood tests, and vital signs so that researchers can compare brain and blood measures before and after NR treatment. Researchers will compare each participant's brain NAD+ to NADH ratio and other bioenergetic markers before and after NR to see if NR changes these measures in a consistent way. If NR raises brain NAD+ and improves measures of energy metabolism in healthy adults, this may provide important background information for future studies that test whether NR can help people with psychiatric or neurological disorders linked to mitochondrial dysfunction and oxidative stress. There is no expected direct health benefit for participants, but their involvement may help improve understanding of how NR affects human brain metabolism. Type: Interventional Start Date: Jun 2026 |
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Visual and Patient Reported Outcomes With Clareon TruPlus
OVO LASIK + Lens
Cataract
This is a prospective, single-site, two-surgeon, single-arm, observational study
evaluating the Clareon TruPlus IOL. Subjects will be assessed up to 3 months
post-operatively. Clinical evaluations will include refractive outcomes, visual acuity,
and administration of the IOLSAT Questionnaire. expand
This is a prospective, single-site, two-surgeon, single-arm, observational study evaluating the Clareon TruPlus IOL. Subjects will be assessed up to 3 months post-operatively. Clinical evaluations will include refractive outcomes, visual acuity, and administration of the IOLSAT Questionnaire. Type: Observational Start Date: Jun 2026 |