
Search Clinical Trials
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Experience and Management of Cancer Screening-Related Anxiety in Fanconi Anemia
National Cancer Institute (NCI)
Fanconi Anemia
Background:
Fanconi anemia (FA) is a rare, inherited cancer syndrome. FA causes a range of physical
issues. Children with FA may have abnormal features; these may include a small head and
eyes and issues with their internal organs. Young adults have a much higher risk of
cancer. To screen for thes1 expand
Background: Fanconi anemia (FA) is a rare, inherited cancer syndrome. FA causes a range of physical issues. Children with FA may have abnormal features; these may include a small head and eyes and issues with their internal organs. Young adults have a much higher risk of cancer. To screen for these cancers, people with FA may need to pursue many visits with different doctors. This constant need for cancer screening may cause anxiety for people with FA. Objective: To learn more about anxiety related to cancer screenings in people with FA. Eligibility: Adults aged 18 years and older with FA. They must also be enrolled in FACSS. FACSS is a study that screens people with FA for cancer every year. Design: All data gathered for this study will occur during routine FACSS visits. No other visits are needed. An observer will be in the room during participants FACSS visits. The observer and participant will have a polite introduction. After that, the observer will not interact with participants in any way. The observer will note details about the participants, such as: - Body language. - Worries about screening. - Comments that suggest anxiety or depression. - Clinical environment, such as d(SqrRoot)(Copyright)cor and temperature. - Accessibility issues. These can include lights and noises as well as ease of traveling around the clinic center. - Evidence of social support, such as engaging in the FA community. - Challenges they ve had in FACSS. - Their motivation to participate in FACSS. - Relationship dynamics among clinic staff, participants, and their care partners. Data will also be collected from FACSS visit notes dating back to December 2024 and from participants medical records. Type: Observational Start Date: Jul 2026 |
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Long-Term Follow up of Patients Undergoing Hematopoietic Stem Cell Transplantation, Cellular Therap1
National Cancer Institute (NCI)
Cellular Immunotherapy, Adoptive
Genetic Therapy
Tissue Donors
Hematopoietic Stem Cell Transplantation
Background:
People who have had an allogeneic hematopoietic stem cell transplant (HCT), cellular
therapy (CT), or gene therapy (GT) have bone marrow or an immune system that is damaged.
They get stem cells from a donor who is a relative. Researchers want to study stem cell
donors and recipients to1 expand
Background: People who have had an allogeneic hematopoietic stem cell transplant (HCT), cellular therapy (CT), or gene therapy (GT) have bone marrow or an immune system that is damaged. They get stem cells from a donor who is a relative. Researchers want to study stem cell donors and recipients to learn about the long-term effects of HCT, CT, or GT. They want to learn how the stem cells change and how to improve their ability to fight cancer. Objective: To provide long-term follow-up care for people who underwent or will undergo HCT, CT, or GT. To collect data, blood, and tissue samples to learn about late complications after HCT, CT, or GT. Eligibility: Adults age 18 and older who will undergo HCT or underwent HCT, Cellular Therapy (CT), or Gene Therapy (GT) and are surviving one year or more from the date of therapy. The stem cell donors for these recipients are also needed. Design: Recipients will have 1 visit each year. They will have a physical exam. They will answer questions about their medical history and health. They will receive screening and surveillance testing. They will complete brief questionnaires. Recipients will have blood tests. They may have tissue biopsies or specimens (such as tissue in their cheek or skin or bone marrow biopsy). Recipients will give their current address and phone number, and the same data for one or two other people, who can get in contact with them. After the first visit at the clinic, some recipients may see a doctor close to home to get the necessary information and send it to NIH. Donors will come to the clinic for 1 visit. They will answer questions about their medical history. Blood samples will be taken. Type: Observational Start Date: Apr 2017 |
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Tissue Procurement and Natural History Study of Patients With Malignant Mesothelioma
National Cancer Institute (NCI)
Thymoma
Stomach Neoplasms
Pancreatic Neoplasms
Mesothelioma
Biliary Tract Neoplasms
Background:
- Malignant mesothelioma is a malignancy arising from the mesothelial cells of the
pleura, peritoneum, pericardium, or tunica vaginalis.
- Mesothelioma accounts for 0.10% of deaths annually in the United States. Malignant
pleural mesothelioma is the most common of thes1 expand
Background: - Malignant mesothelioma is a malignancy arising from the mesothelial cells of the pleura, peritoneum, pericardium, or tunica vaginalis. - Mesothelioma accounts for 0.10% of deaths annually in the United States. Malignant pleural mesothelioma is the most common of these, comprising of 80% of the cases with an annual incidence of about 2,500 in the United States. - The median survival from diagnosis of pleural mesothelioma is approximately 12 months. The majority of patients present with stage III or IV disease with 85-90% of patients considered unresectable at diagnosis. - Peritoneal mesothelioma has a better prognosis than pleural mesothelioma; nevertheless, patients undergoing therapy for peritoneal mesothelioma have few well-studied treatment options due in large part to the rarity of the disease. - In addition to mesothelioma, mesothelin is highly expressed in several cancers, including pancreatic, biliary adenocarcinomas, gastric and ovarian cancers; mesothelin is also expressed in a significantly larger proportion of thymic carcinoma than thymoma. Objectives: -To allow sample acquisition for use in the study of mesothelioma. Eligibility: - All participants age greater than or equal to 2 years with malignant mesothelioma OR - All participants greater than or equal to 18 years with thymic carcinoma, pancreatic or biliary adenocarcinoma or lung, gastric or ovarian cancers or other solid tumor known to express mesothelin - Must be able and willing to provide informed consent if 18 or over; parent or guardian must be able and willing to provide consent for patients under the age of 18 Design: - Up to 1000 subjects will be enrolled. - Patients will be followed to determine the course of disease and to record any treatment received for mesothelioma. - Patients will undergo sampling of blood, urine, tumor and abnormal body fluids for tissue banking. - Studies which may be performed on banked material include genetic and genomic studies, establishment of cell cultures and immunologic studies. Type: Observational Start Date: Sep 2013 |
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Escalating Doses of VAS-101 in Subjects With Stable Sickle Cell Disease
National Heart, Lung, and Blood Institute (NHLBI)
Sickle Cell Disease, Hemolytic Anemia
Background:
Sickle cell disease (SCD) is an inherited blood disorder. The disease affects the ability
of red blood cells to carry oxygen. Research has shown that curcumin, a natural compound
found in turmeric, can improve the health of red blood cells in people with SCD. But the
body cannot absorb1 expand
Background: Sickle cell disease (SCD) is an inherited blood disorder. The disease affects the ability of red blood cells to carry oxygen. Research has shown that curcumin, a natural compound found in turmeric, can improve the health of red blood cells in people with SCD. But the body cannot absorb curcumin well when it is taken by mouth. Researchers want to know if a skin gel (VAS-101) can help the body better absorb curcumin. VAS-101 contains curcumin, which comes from turmeric. Objective: To test VAS-101 in people with stable SCD. Eligibility: People aged 18 to 70 years with stable SCD. Design: People who want to join the study will be screened with physical exam with blood tests to see if they are eligible. If they qualify, they can enroll in the study. Participants will have up to 15 clinic visits over about 14 weeks. Some may need to stay overnight in the hospital for up to 2 days to make it easier to collect blood samples after the gel is applied. For 6 weeks, a special gel called VAS-101 will be put on the forearms in the clinic two times a week. Staff will rub the gel into the skin for at least 30 seconds using a soft toothbrush. The area stays uncovered for at least 10 minutes, then is covered with a bandage or sleeve. After 24 hours, the dressing can be removed and the skin can be washed. Some visits will include blood tests and other exams. On three visits, a test called near infrared spectroscopy (NIRS) will be done. For this test, probes are placed on the skin to measure blood flow, oxygen levels, and the makeup of skin and muscle. A blood pressure cuff is used to squeeze the arm for up to 5 minutes. The last clinic visit will happen about 4 weeks after the final gel application.... Type: Interventional Start Date: Jul 2026 |
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Whole Exome and Whole Genome Sequencing for Genotyping of Inherited and Congenital Eye Conditions
National Eye Institute (NEI)
Genetic Eye Disease
Objective: The objective of this study is to identify genetic causes of inherited eye
conditions through whole exome or whole genome sequencing (referred to as exome
sequencing and genome sequencing in the remainder of the document). This includes
identifying mutations in known genes or novel genes1 expand
Objective: The objective of this study is to identify genetic causes of inherited eye conditions through whole exome or whole genome sequencing (referred to as exome sequencing and genome sequencing in the remainder of the document). This includes identifying mutations in known genes or novel genes for recognized conditions, as well as identifying mutations in novel genes for previously uncharacterized genetic conditions involving the eye. Study Population: We plan to recruit 2,000 participants, to include both participants with an eye condition under study and unaffected family members. Ideally unaffected family members will be parents of an affected participant. Design: Participants will be self-referred or referred by an outside clinician. They will preferably be evaluated at the National Institutes of Health (NIH), but the option to participate offsite will be offered. Participants evaluated onsite will be recruited through other pre-existing NIH protocols, such as the National Eye Institute (NEI) Screening protocol (08-EI-0102), the NEI Ocular Natural History protocol (16-EI-0134), the Genetics of Inherited Eye Disease protocol (15-EI-0128), and the Pathogenesis and Genetics of Microphthalmia, Anophthalmia and Uveal Coloboma (MAC) protocol (13-EI-0049). Offsite participants will be screened via phone or secure videoconference, and records will be requested for evaluation of affected participants. Both affected and unaffected eligible participants will undergo genetic counseling and will provide a blood sample and/or saliva sample for exome or genome sequencing. Biological relationships will be confirmed prior to exome or genome sequencing. Sequence data will be analyzed for primary variants and secondary findings, unless participants choose to opt-out of secondary analysis and reporting. All sequence variants deemed clinically relevant will be validated in a Clinical Laboratory Improvement Amendment (CLIA)-certified laboratory. The results will be returned to the participant in-person, secure videoconference, or by telephone. Outcome Measures: This is an etiologic study that will generate molecular information about previously-recognized conditions for which participants did not have a molecular diagnosis, as well as molecular information for previously uncharacterized conditions involving the eye. Type: Observational Start Date: Aug 2014 |
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Collection of Human Samples to Study Hairy Cell and Other Leukemias, and to Develop Recombinant Imm1
National Cancer Institute (NCI)
Hairy Cell Leukemia (HCL)
Chronic Lymphocytic Leukemia (CLL)
Non-Hodgkins Lymphoma (NHL)
Cutaneous T Cell Lymphoma (CTCL)
Adult T Cell Lymphoma (ATL)
Background:
- Researchers who are studying hairy cell leukemia, and how the disease compares with
other disorders, are interested in obtaining additional samples from leukemia patients
and healthy volunteers. The investigators are particularly interested in samples from
individuals who have diseas1 expand
Background: - Researchers who are studying hairy cell leukemia, and how the disease compares with other disorders, are interested in obtaining additional samples from leukemia patients and healthy volunteers. The investigators are particularly interested in samples from individuals who have diseases that can be treated with a new type of drug called immunotoxin, in which an antibody carrying a toxin binds to a cancer cell and allows the toxin to kill the cell. Objectives: - To collect a variety of clinical samples, including blood, urine, lymph samples, and other tissues, in order to study the samples and develop new treatments for leukemia. Eligibility: - Individuals 18 years of age and older who have been diagnosed with leukemia or other kinds of blood and lymphatic system cancers, or who are healthy volunteers. Design: - Individuals who have leukemia will be asked to provide blood, bone marrow, urine, and tumor tissue samples as requested by the researchers. Healthy volunteers will provide only blood and urine samples. - No treatment will be given as part of this protocol. Type: Observational Start Date: Mar 2010 |
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Clinical and Laboratory Study of Methylmalonic Acidemia
National Human Genome Research Institute (NHGRI)
Organic Acidemia
Methylmalonic Acidemia
Inborn Errors of Metabolism
Methylmalonic acidemia (MMA), one of the most common inborn errors of organic acid
metabolism, is heterogeneous in etiology and clinical manifestations. Affected patients
with cblA, cblB and mut classes of MMA are medically fragile and can suffer from
complications such as metabolic stroke or infar1 expand
Methylmalonic acidemia (MMA), one of the most common inborn errors of organic acid metabolism, is heterogeneous in etiology and clinical manifestations. Affected patients with cblA, cblB and mut classes of MMA are medically fragile and can suffer from complications such as metabolic stroke or infarction of the basal ganglia, pancreatitis, end stage renal failure, growth impairment, osteoporosis, and developmental delay. The frequency of these complications and their precipitants remain undefined. Furthermore, current treatment protocol outcomes have continued to demonstrate substantial morbidity and mortality in the patient population. Increasingly, solid organ transplantation (liver, and/or kidney) has been used to treat patients. Disordered transport and intracellular metabolism of vitamin B12 produces a distinct group of disorders that feature methylmalonic acidemia as well as (hyper)homocysteinemia. These conditions are named after the corresponding cellular complementation class - (cblC, cblD, cblF, cblJ and cblX) - and are also heterogenous, clinically and biochemically. The genetic disorders underlying cblE and cblG feature an isolated impairment of the activity of methionine synthase, a critical enzyme involved in the conversion of homocysteine to methionine and these disorders feature (hyper)homocysteinemia. Lastly, a group of patients can have increased methylmalonic acid and/or homocysteine in the blood or urine caused by variant(s) in recently identified (ACSF3) and unknown genes. In this protocol, we will clinically evaluate patients with methylmalonic acidemia and cobalamin metabolic defects. Routine inpatient admissions will last up to 4-5 days and involve urine collection, blood drawing, ophthalmological examination, radiological procedures, MRI/MRS, skin biopsies in some, and developmental testing. In a subset of patients who have or will receive renal, hepato- or hepato-renal transplants or have an unusual variant or clinical course and have MMA, a lumbar puncture to examine CSF metabolites will be performed. In this small group of patients, CSF metabolite monitoring may be used to adjust therapy. The study objectives will be to further delineate the spectrum of phenotypes and characterize the natural history of these enzymopathies, query for genotype/enzymatic/phenotype correlations, search for new genetic causes of methylmalonic acidemia and/or homocysteinemia, identify new disease biomarkers and define clinical outcome parameters for future clinical trials. The population will consist of participants previously evaluated at NIH, physician referrals, and families directed to the study from clinicaltrials.gov as well as the Organic Acidemia Association, Homocystinuria Network America and other national and international support groups. Most participants will be evaluated only at the NIH Clinical Center. However, if the NIH team decides that a patient under the age of 2 years is a candidate subject for this research protocol, that patient may enroll at the Children's National Medical Center (CNMC) site, pending approval by Dr Chapman, the Principal Investigator of the CNMC location Individuals may also enroll in the tissue collection only part of the study at the UPMC Children's Hospital of Pittsburgh or share medical history and clinical data via telemedicine visits remotely. Outcome measures will largely be descriptive and encompass correlations between clinical, biochemical and molecular parameters. Type: Observational Start Date: Jun 2004 |
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PET Imaging of Phosphodiesterase-4 (PDE4) in Volunteers With Alzheimer Disease (AD) or Mild Cogniti1
National Institute of Mental Health (NIMH)
Alzheimer s Disease
Mild Cognitive Impairment
Healthy
Background:
About 5 million adults in the United States have age-related brain disorders. These
include Alzheimer disease (AD), mild cognitive impairment (MCI), and other dementias. The
number of people with these disorders will likely increase as the population ages and
life span increases. Infla1 expand
Background: About 5 million adults in the United States have age-related brain disorders. These include Alzheimer disease (AD), mild cognitive impairment (MCI), and other dementias. The number of people with these disorders will likely increase as the population ages and life span increases. Inflammation is thought to play a role in AD and MCI. Researchers want to know if an enzyme called PDE4B increases inflammation in people with AD or MCI. Objective: To test whether medical imaging using a new radiotracer ([18F]PF-06445974) can measure PDE4B in the brains of people with AD or MCI. Eligibility: People aged 50 years and older with AD or MCI. Healthy volunteers are also needed. Design: Participants will have up to 5 clinic visits with 3 imaging scans of the brain. They will have be screened. They will have a physical exam with blood tests. This will include tests of their heart and nerve function, including memory. Participants will have 2 positron emission tomography (PET) scans. One will use a standard radiotracer. The other will use the study radiotracer. They will receive each tracer through a tube attached to a needle inserted into a vein. During the scan with the study tracer, participants will have a second tube inserted into a vein in the wrist; this tube will be used to draw blood during the scan. Participants will lie on a bed that slides into a doughnut-shaped machine. These visits will take about 6 hours each. Participants will have 1 magnetic resonance imaging (MRI) scan. They will lie on a bed that slides into a cylinder. This visit will take up to 2 hours.... Type: Interventional Start Date: Jul 2026 |
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Acute Effects of Alcohol on PET Imaging of Phosphodiesterase-4B (PDE4B)
National Institute of Mental Health (NIMH)
Alcohol Use Disorder
Background:
Phosphodiesterase-4B (PDE4B) is a protein in the brain that may play a role in several
mental health disorders. Researchers want to know if drinking alcohol increases the
binding of a radioactive tracer to PDE4B in the brain because of increased activity
and/or amount of the protein. T1 expand
Background: Phosphodiesterase-4B (PDE4B) is a protein in the brain that may play a role in several mental health disorders. Researchers want to know if drinking alcohol increases the binding of a radioactive tracer to PDE4B in the brain because of increased activity and/or amount of the protein. This knowledge may help create new ways to treat people with alcohol use disorder (AUD). Objective: To learn if alcohol increases PDE4B activity in the brain. Eligibility: Healthy people aged 21 to 70 years who drink socially but do not have AUD. They must be enrolled in protocol 14-AA-0181"NIAAA Natural History Protocol". Design: Participants will have up to 4 clinic visits with up to 3 imaging scans of the brain; these will include 1 or 2 positron emission tomography (PET) scans and 1 magnetic resonance imaging (MRI) scan. The first PET scan will be a baseline. Participants will receive a radioactive tracer through a tube inserted into a vein. A second tube will be inserted so that blood can be drawn during the scan. Participants will lie on a bed that slides into a doughnut-shaped machine. This visit will take about 6 hours. For the next PET scan, participants will receive alcohol (ethanol) through a tube in a vein until they have a blood alcohol concentration that is equal to the legal driving limit. This is the same as 4 or 5 drinks for most people. After the scan, participants must remain at the clinic for a few hours until their blood alcohol drops. This visit will take 14 to 16 hours. The MRI scan of the brain will take up to 2 hours in a separate clinic visit. Type: Interventional Start Date: Dec 2025 |
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PET Imaging of Cyclooxygenase-1 in Participants With Neurological Manifestations of Post-Acute Sequ1
National Institute of Mental Health (NIMH)
Long COVID
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
long-term symptoms that affect the brain. These include headaches; loss of taste and
smell; sleep problems; thinking problems; depression; and anxiety. Researchers want to
know if a tracer (a subst1 expand
Background: SARS-CoV-2 is the virus that causes COVID-19. Some people who recover from COVID-19 have long-term symptoms that affect the brain. These include headaches; loss of taste and smell; sleep problems; thinking problems; depression; and anxiety. Researchers want to know if a tracer (a substance that is injected into a person s body before an imaging scan) can help identify inflammation in people with these brain disorders. Objective: To see if a radioactive tracer ([11C]PS13) can highlight brain inflammation in those who had COVID-19 but still have symptoms that affect the brain. Eligibility: Adults aged 18 to 70 years with post COVID-19 brain disorders who are enrolled in protocol 000089 or 000711. Healthy volunteers are also needed. Design: Participants will have up to 5 clinic visits. Participants will be screened. They will have blood tests and a test of their heart function. They will have imaging scans: Magnetic resonance imaging (MRI): They will lie on a table that slides into a metal tube. Pictures will be taken of the brain. Positron emission tomography (PET): A needle attached to a thin tube will be inserted into a vein in the arm. The tracer will be injected through the tube. Another needle attached to a thin tube will be inserted into the wrist or inside of the elbow of the other arm to draw blood. They will lie still on a bed while a machine captures images of their brain. The scan will last about 2 hours. Study involvement is 11 to 14 weeks.... Type: Interventional Start Date: Jun 2025 |
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A Prospective Natural History Study of Lymphatic Anomalies
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Lymphatic Diseases
Lymphatic Abnormalities
Background:
The lymphatic system is a network of vessels that carry a clear fluid called lymph
through the body. Problems in the lymphatic system can cause pain, fluid buildup, and
issues with immunity. There is much researchers do not understand about lymphatic
anomalies. In this natural history1 expand
Background: The lymphatic system is a network of vessels that carry a clear fluid called lymph through the body. Problems in the lymphatic system can cause pain, fluid buildup, and issues with immunity. There is much researchers do not understand about lymphatic anomalies. In this natural history study, they will collect data from a lot of people over a long time. Objective: To better understand why lymphatic anomalies develop. The goal is to improve future treatments. Eligibility: People aged 0 days and older with a suspected or confirmed lymphatic anomaly. Their unaffected parents or siblings aged 7 years or older are also needed. Design: Participants may remain in the study indefinitely. Affected participants may be evaluated every 10 months to 2 years. Some participants will be seen over telemedicine. Others will be seen at the NIH Clinical Center for 2-5 days. All participants will have a physical exam. They may provide specimens including blood, saliva, hair follicles, stool, skin, and other tissues. Samples may be used for genetic testing. Participants may undergo other tests depending on their medical conditions. The NIH Clinical Center visit may include: Heart tests include placing stickers on the chest to measure electrical activity and using sound waves to capture pictures of the heart. A lung test measures the muscle strength in the chest. Participants will blow into a tube. Photographs may be taken of participants faces and other features. Imaging scans will take pictures of the inside of the body. One scan will measure bone density. One type of scan tracks how lymph fluid moves through the body. Participants will be under anesthesia, and they will be injected with a dye. Type: Observational Start Date: Mar 2023 |
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Orexin s Role in the Neurobiology of Substance Use Disorder
National Institute on Drug Abuse (NIDA)
Nicotine Dependence
Study Description:
Despite the availability of pharmacotherapy for some substance use disorders, relapse
vulnerability is still a significant issue. This suggests medications with alternative
mechanisms of action should be explored to address this unmet need. Substantial
preclinical research indic1 expand
Study Description: Despite the availability of pharmacotherapy for some substance use disorders, relapse vulnerability is still a significant issue. This suggests medications with alternative mechanisms of action should be explored to address this unmet need. Substantial preclinical research indicates that orexin antagonism blunts the internally and externally triggered motivation to attain abused substances. This research project will translate these preclinical findings into the clinical domain by administering the FDA approved orexin antagonist, suvorexant, to those with a substance use disorder. Suvorexant s ability to blunt neurobiological correlates of substance misuse will be assessed. This will be assessed following acute and repeated drug administration. Baseline individual differences will be considered to determine whether neurobiological variance influences suvorexant s impact in those with nicotine dependence. In an independent arm, the interaction between suvorexant and a dopamine agonist (methylphenidate) on cognitive function will be assessed in non-smoking individuals. Objectives: The objective is to determine the acute and chronic impact of the orexin antagonist, suvorexant, on neurobiological and behavioral factors linked with substance use disorders. Whether such effects are mediated by baseline characteristics will be tested. Given suvorexant is an FDA approved treatment for insomnia, sleep will be evaluated as well in the nicotine dependent arm. Endpoints: In nicotine-dependent individuals, suvorexant s impact on brain function will be assessed several ways by evaluating: 1) resting function, 2) reactivity to drug cues, 3) reactivity to non-drug related cognitive tasks. Sleep and nicotine use will be measured throughout the study period. In those without nicotine-dependence, the impact of suvorexant and the interaction of acute methylphenidate and suvorexant on brain function will be assessed. This arm will provide insight into how suvorexant impacts reward/cognition as well as impacts the pharmacological influence of methylphenidate on those same measures. Study Population:<TAB> Nicotine dependence arm:140 subjects; Volunteers who are between the ages of 18-60 and are daily smokers/vapers. Control arm: 80 subjects; Volunteers who are between the ages of 18-60 and are non-smokers/vapers This study will be conducted at the NIDA-IRP, Biomedical Research Center, in Baltimore, MD. Description of Study Intervention: Nicotine dependence arm: Suvorexant at 10 mg single dose, and Suvorexant at 10 mg daily for approximately 7 days. Control arm: 1. Tolerability visit with one MRI scan post-20mg methylphenidate, 4 acute drug administration (6-14 days in randomized order: 1. Placebo + placebo; 2. 20mg suvorexant + Placebo; 3. Placebo + 40mg methylphenidate; 4. 20 mg suvorexant + 40mg methylphenidate max) Study Duration: 5 years Participant Duration: 1-2 months Type: Interventional Start Date: Feb 2023 |
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Clinical, Laboratory, and Epidemiologic Characterization of Individuals and Families at High Risk o1
National Cancer Institute (NCI)
Melanoma
Dysplastic Nevus Syndrome
This study will investigate how genetic and environmental factors contribute to the
development of melanoma, a type of skin cancer, and related conditions.
Individuals >=4 weeks with a personal or family history of melanoma or atypical
spitzoid/Spitz tumor may be eligible for this study. Participa1 expand
This study will investigate how genetic and environmental factors contribute to the development of melanoma, a type of skin cancer, and related conditions. Individuals >=4 weeks with a personal or family history of melanoma or atypical spitzoid/Spitz tumor may be eligible for this study. Participants will: - Fill out one or two questionnaires about their personal and family medical history. - Provide written consent for researchers to review their medical records and pathology materials related to their care and those of deceased relatives with melanomas, tumors, cancer, or other related illnesses for whom they are the next-of-kin or legally authorized representative. - Donate a blood or cheek cell sample to be used for genetic studies. (The blood sample is collected through a needle in an arm vein. The cheek cell sample is obtained either by gently brushing the inside of the mouth with a soft brush or by swishing a tablespoon of mouthwash and then spitting it into a container.) - Undergo a skin biopsy (removal of a small piece of skin tissue) for genetic study. For this procedure, the area of skin to be removed is numbed with a local anesthetic and a 1/4-inch piece of skin is excised with a cookie cutter-like instrument. The wound is then covered with a band-aid. Participants may be asked to travel to the NIH Clinical Center for evaluation, including a medical history, physical examination, and some of the following procedures: - Full body skin examination to evaluate the type and number of moles and document any evidence of sun damage to the skin. The examination involves all the skin from the scalp to the bottoms of the feet. After the examination, a medical photographer will photograph the skin, with close-ups of skin lesions marked by the examiner. If there are parts of the skin the participant does not want examined or photographed, he or she can tell the examiner. - Blood draw of about 120 milliliters (4 ounces) or less - Skin biopsy - Cheek cell sample - X-rays, ultrasound and magnetic resonance imaging (MRI) studies to detect tumors or changes in tumors or other types of changes in specific tissues. MRI is a diagnostic test that uses strong magnetic fields and radiowaves to examine body tissues. The subject lies on a table that is moved into a large tunnel-like machine (the scanner) for about 45 minutes to 1 hour. When the tests are finished, a doctor will discuss the results with the participant and the need, if any, for clinical follow-up. Type: Observational Start Date: Jul 2002 |
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Digital and Plasma Biomarkers in Delirium
Scripps Health
Critical Illness
Delirium in the Intensive Care Unit
Sleep Quality
The goal of this observational study is to learn if there are potential digital and
plasma-based biomarkers that could help detect, predict, and prognosticate delirium in
older adult patients who are admitted to the intensive care unit (ICU). The main question
DELTA aims to answer is:
Can digital1 expand
The goal of this observational study is to learn if there are potential digital and plasma-based biomarkers that could help detect, predict, and prognosticate delirium in older adult patients who are admitted to the intensive care unit (ICU). The main question DELTA aims to answer is: Can digital biometrics predict and detect delirium in older adult ICU patients? Do biomarkers of neurodegeneration fluctuate in ICU patients in such a way that delrium could potentially be predicted? Participants admitted o the ICU will wear a digital device to collect biometric data and will have serial plasma samples collected during ICU admission and patients will be also assessed for delirium daily by study staff. Type: Observational Start Date: May 2026 |
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A Study of ARC-02 in B-cell NHL
Taiho Oncology, Inc.
B-cell Non Hodgkin Lymphoma
This study is to assess safety, tolerability, pharmacokinetics (PK), pharmacodynamic
(PD), and preliminary efficacy of ARC-02. expand
This study is to assess safety, tolerability, pharmacokinetics (PK), pharmacodynamic (PD), and preliminary efficacy of ARC-02. Type: Interventional Start Date: Jun 2026 |
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A Study of a New PET Scanner in People With Cancer
Memorial Sloan Kettering Cancer Center
Non Small Cell Lung Carcinoma NSCLC
Head and Neck Cancer
Prostate Cancer
The researchers are doing this study to test the capabilities of a new total-body PET
scanner called the Biograph Vision Quadra. The researchers want to learn whether this
scanner can produce better PET/CT images and provide more useful imaging information than
standard PET/CT scanners. expand
The researchers are doing this study to test the capabilities of a new total-body PET scanner called the Biograph Vision Quadra. The researchers want to learn whether this scanner can produce better PET/CT images and provide more useful imaging information than standard PET/CT scanners. Type: Observational Start Date: Jun 2026 |
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Breathing for Two: Inspiratory Muscle Strength Training for Supporting Healthy Blood Pressure in Pr1
University of Arizona
Hypertension Disorders in Pregnancy
Blood Pressure Measurement in Pregnancy
Inspiratory Strength Training (IST)
Pregnancy
This is an interventional study that will test whether a breathing exercise called
Inspiratory Muscle Strength Training (IMST) can safely and effectively lower blood
pressure during late pregnancy. The goal is to see if a home-based breathing training can
help prevent or reduce high blood pressure1 expand
This is an interventional study that will test whether a breathing exercise called Inspiratory Muscle Strength Training (IMST) can safely and effectively lower blood pressure during late pregnancy. The goal is to see if a home-based breathing training can help prevent or reduce high blood pressure disorders in pregnancy. The main objectives are to make sure the training is safe and tolerable for pregnant women and to examine blood pressure and blood vessel health. Participants in their third trimester will be randomly assigned to either do moderate resistance IMST or a minimal resistance sham IMST, for 5 to 8 minutes a day over six weeks. Type: Interventional Start Date: Jun 2026 |
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Natural History of Trisomy 8-Associated Autoinflammatory Disease (TRIAD) and Related Disorders
National Institute of Allergy and Infectious Diseases (NIAID)
Trisomy 8 Mosaicism
Trisomy 8 Associated Autoinflammatory Disease
Mucosal Ulcerations
Background:
Trisomy 8 mosaicism is a genetic disorder that can increase inflammation in the body.
Symptoms include fevers; sores or ulcers in the mouth, digestive tract, or genital area;
skin rashes; problems in organs or tissues; and changes in bone marrow cells. Researchers
want to conduct a nat1 expand
Background: Trisomy 8 mosaicism is a genetic disorder that can increase inflammation in the body. Symptoms include fevers; sores or ulcers in the mouth, digestive tract, or genital area; skin rashes; problems in organs or tissues; and changes in bone marrow cells. Researchers want to conduct a natural history study to learn more about these symptoms and what causes them. Objective: To gather data and samples from people with and without the trisomy 8 mosaicism. Eligibility: People of any age with the trisomy 8 gene mosaicism. Their healthy relatives are also needed. Design: Affected participants will have visits every 1 to 2 years for 30 years at NIH. Each visit will take 1 to 5 days and may be in-person or remote. With remote visits, participants may have a video call with the study team and samples may be sent to researchers by mail. Participants may have these procedures: Physical exam, with blood tests. Tests of brain function and motor skills. Sensory tests. Researchers will see how participants respond to sensations such as pinpricks, heat, cold, and pressure. Magnetic resonance imaging (MRI) scan of the brain and/or spine. X-ray of the spine. Ultrasound test of heart function (echocardiogram). Tissues samples (biopsies) collected from the skin, inside of the mouth, and bone marrow. Swabs to collect cells from the mouth, skin, and vagina. Collection of blood, stool, urine, saliva, hair, and fingernail samples. X-rays, MRI, and heart tests will be done only once. Other procedures may be repeated at each visit. All tests and procedures are voluntary. Healthy relatives who enroll will have a baseline visit and then follow-up visits as needed. They will have a physical exam. The inside of their mouth may be swabbed. Samples of blood, stool, urine, and saliva may be taken. Type: Observational Start Date: Jul 2026 |
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A Study to Assess Nipocalimab Concentrations in Breast Milk of Healthy Lactating Women
Janssen Research & Development, LLC
Healthy
The main purpose of this study is to assess the concentrations of nipocalimab
(pharmacokinetics [PK]) in the breast milk after administration of a single dose of
nipocalimab into the vein, in healthy lactating women. expand
The main purpose of this study is to assess the concentrations of nipocalimab (pharmacokinetics [PK]) in the breast milk after administration of a single dose of nipocalimab into the vein, in healthy lactating women. Type: Interventional Start Date: Jun 2026 |
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Artificial Intelligence (AI) for Proximal Caries Detection and Its Impact on Treatment Threshold
University of Michigan
Caries,Dental
The purpose of this study is to assess the impact of artificial intelligence on proximal
caries detection and subsequent treatment decisions of early learners and compare those
with outcomes of experienced learners. expand
The purpose of this study is to assess the impact of artificial intelligence on proximal caries detection and subsequent treatment decisions of early learners and compare those with outcomes of experienced learners. Type: Interventional Start Date: Jul 2026 |
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kTMP-Enhanced Motor Rehabilitation for Chronic Stroke Recovery (KULMINATE) Pilot
Magnetic Tides
Stroke
Chronic Stroke Patients
Arm Weakness as a Consequence of Stroke
kTMP, kilohertz transcutaneous magnetic perturbations, is a low intensity transcranial
magnetic stimulation technique that will be used in this study to promote arm/hand
rehabilitation in patients who have been disabled by stroke. expand
kTMP, kilohertz transcutaneous magnetic perturbations, is a low intensity transcranial magnetic stimulation technique that will be used in this study to promote arm/hand rehabilitation in patients who have been disabled by stroke. Type: Interventional Start Date: Jul 2026 |
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A Study of Investigational RSV/hMPV Combination and Investigational hMPV Vaccines in Younger and Ol1
GlaxoSmithKline
Respiratory Syncytial Virus Infections+Metapneumovirus
The aim of this study is to evaluate the safety, reactogenicity, and immune response of
the different formulations of the investigational RSV/hMPV combination vaccine and
investigational hMPV vaccine in younger and older adults. expand
The aim of this study is to evaluate the safety, reactogenicity, and immune response of the different formulations of the investigational RSV/hMPV combination vaccine and investigational hMPV vaccine in younger and older adults. Type: Interventional Start Date: Jun 2026 |
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Fast-Her: Fasting Effects on Breast Cancer Treatment
University of Minnesota
Metastatic Breast Cancer
We hypothesize that promoting a fasting state will strengthen the anti-cancer effects of
PI3K inhibitors in metastatic breast cancer (MBC) treatment. The primary objective of
this study is to assess acceptability of prolonged fasting in this population. expand
We hypothesize that promoting a fasting state will strengthen the anti-cancer effects of PI3K inhibitors in metastatic breast cancer (MBC) treatment. The primary objective of this study is to assess acceptability of prolonged fasting in this population. Type: Interventional Start Date: May 2026 |
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Two Arm, Double-blind, Phase III Study Assessing Efficacy and Safety of Ianalumab Versus Placebo, i1
Novartis Pharmaceuticals
Sjögren´s Disease
The purpose of this study is to demonstrate the efficacy and safety of ianalumab (VAY736)
300 mg administered subcutaneously (s.c.) monthly for 52 weeks in adult participants with
Sjögren's disease who have high symptom burden. expand
The purpose of this study is to demonstrate the efficacy and safety of ianalumab (VAY736) 300 mg administered subcutaneously (s.c.) monthly for 52 weeks in adult participants with Sjögren's disease who have high symptom burden. Type: Interventional Start Date: Jul 2026 |
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A Study of the Feasibility, Safety and Tolerability of Aticaprant as Adjunctive Treatment in Partic1
Janssen Research & Development, LLC
Schizophrenia
The purpose of this study is to see how feasible it is to enroll participants with
schizophrenia and for them to complete the study/assessments. It will also assess how
safe and tolerable aticaprant is when compared with placebo in participants with
schizophrenia. expand
The purpose of this study is to see how feasible it is to enroll participants with schizophrenia and for them to complete the study/assessments. It will also assess how safe and tolerable aticaprant is when compared with placebo in participants with schizophrenia. Type: Interventional Start Date: Mar 2026 |