
Search Clinical Trials
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Outcome Inference in the Sensory Preconditioning Task in Opioid-Use Disorder
National Institute on Drug Abuse (NIDA)
Opioid-Related Disorders
Drug Addiction
Background:
People with addictions often find it hard to choose the long-term benefits of abstinence
over the short-term effects of using drugs. Researchers think this is partly due to parts
of the brain involved in certain types of learning and decision-making. Researchers want
to test these basi1 expand
Background: People with addictions often find it hard to choose the long-term benefits of abstinence over the short-term effects of using drugs. Researchers think this is partly due to parts of the brain involved in certain types of learning and decision-making. Researchers want to test these basic functions using a simple task with pictures and odors. Objective: To see if performance in a learning task differs between people who have opioid-use disorder and people who don t. Eligibility: Adults 21-60 years old who are willing to fast for at least 6 hours and smell food odors. Those with an opioid-use disorder must either not use for at least 3 weeks or be in treatment. Design: Participants will have 1 visit that will take up to 5 hours. Before the visit, participants will be asked to not eat or drink anything except water for at least 6 hours. At the visit, participants will be checked for signs of intoxication. Participants will give urine and breath samples. Participants will have tests of learning and behavior. They will look at shapes on a computer screen. The shapes will be paired with different food odors. The odors will come from a sterile tube placed under the nose. Participants will have their breathing monitored with a belt around the upper abdomen. About 30 days and 60 days later, participants will be called and asked about their drug use over the past 30 days. Type: Observational Start Date: Jun 2019 |
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Dupilumab as Add-On Therapy for Hypereosinophilic Syndrome With Partial Clinical Response to Eosino1
National Institute of Allergy and Infectious Diseases (NIAID)
Hypereosinophilic Syndrome
Background:
Hypereosinophilic syndrome (HES) is a blood disorder that causes high levels of white
blood cells called eosinophils. HES can damage the lungs and airways, intestines, skin,
and other organs. The current primary treatment for HES can cause serious side effects.
Secondary treatments do1 expand
Background: Hypereosinophilic syndrome (HES) is a blood disorder that causes high levels of white blood cells called eosinophils. HES can damage the lungs and airways, intestines, skin, and other organs. The current primary treatment for HES can cause serious side effects. Secondary treatments do not work in all people. Objective: To test an approved drug (dupilumab), combined with other drugs, in people with HES. Eligibility: People aged 18 years and older who take drugs (mepolizumab, reslizumab, or benralizumab) to treat HES. Design: Participants will have up to 6 clinic visits and 7 remote visits in up to 48 weeks. Participants will be screened. They will have blood and urine tests. They will have a test of their heart function. They will take surveys about how HES affects their daily life. Some participants may have a bone marrow biopsy: A sample of tissue and fluid from inside a bone will be removed with a large needle. Participants will have other tests specific to their symptoms. For example, those with symptoms affecting their lungs will have breathing tests. Others may have tests that target symptoms in their sinuses, gastrointestinal tract, or skin. Dupilumab is injected under the skin once every 1 or 2 weeks. Dose and timing will vary among participants. They will be taught how to inject themselves at home between clinic visits. They will take dupilumab plus their current medications for 24 weeks. If the drug is helping them, they will continue taking it for another 24 weeks. Participants will have a final visit 12 weeks after their last dose. Type: Interventional Start Date: Feb 2025 |
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Prospective Monitoring of Subjects With Biochemically Recurrent Prostate Cancer Using 18FDCFPyL
National Cancer Institute (NCI)
Prostate Cancer
Biochemically Recurrent
Background:
Prostate cancer is the second leading cause of cancer-related death in American men. The
disease recurs in up to 50,000 men each year after their early-stage disease was treated;
however, at this stage, imaging scans are often unable to find the disease in the body.
In this natural his1 expand
Background: Prostate cancer is the second leading cause of cancer-related death in American men. The disease recurs in up to 50,000 men each year after their early-stage disease was treated; however, at this stage, imaging scans are often unable to find the disease in the body. In this natural history study, researchers want to find out if a new radiotracer (18F-DCFPyL) injected before positron emission tomography (PET) imaging can help identify sites in the body with cancer. Objective: To learn more about how 18F-DCFPyL PET/CT scans detect change over time in men with recurrent prostate cancer. Eligibility: Men aged 18 and older with prostate cancer that returned after treatment. Design: Participants will be screened with blood tests. They will also have a bone scan and a computed tomography (CT) scans of the chest, abdomen, and pelvis. Participants will have an initial study visit. They will have a physical exam and blood tests. They will have a PET/CT scan with 18F-DCFPyL. The radiotracer will be injected into a vein; this will take about 20 seconds. The PET/CT scan will be done 1 to 2 hours later. Participants will lie still on a scanner table while a machine captures images of their body. The scan will take 45 minutes. Participants will return for blood tests every 3 months. Participants will return for additional scans with 18F-DCFPyL on this schedule: Once a year if their previous scan was negative for prostate cancer. Every 6 months if their previous scan was positive for prostate cancer. Participants may be in the study up to 5 years. Type: Observational Start Date: Mar 2023 |
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Characterization of Nociception Phenotype in Individuals With Intellectual Disability
National Institutes of Health Clinical Center (CC)
Intellectual Disability
Background:
People with intellectual disability (ID) often have physical disabilities as well. These
physical problems can affect their bones, muscles, nerves, and gastrointestinal tracts.
All of these issues can also cause pain. Yet little research has been done on pain in
people with ID.
Object1 expand
Background: People with intellectual disability (ID) often have physical disabilities as well. These physical problems can affect their bones, muscles, nerves, and gastrointestinal tracts. All of these issues can also cause pain. Yet little research has been done on pain in people with ID. Objective: To compare brain responses to unpleasant stimuli in people with and without ID. Eligibility: People aged 8 to 30 years diagnosed with an ID. Healthy volunteers without an ID are also needed. Design: The study requires only 1 visit of up to 4 hours. Participants with ID may come for up to 5 shorter visits instead. Participants will take a test to measure their level of ID. They will have a physical exam. Both groups will answer questions about pain and how their bodies react to it. They will answer questions about how they respond to things they see, feel, hear, smell, and taste. They will answer questions about their social behaviors. Caregivers may answer questions if the participant cannot. Both groups will have a test to measure their brain activity. Participants will wear a special cap, like a swim cap, with sensors and wires. Sensors to examine the heart will be placed on the skin of their chest with stickers. An elastic band will be placed around the middle of their body to measure how fast they are breathing. Sensors to measure sweat will be placed on two fingers. Participants will have heat, cold, brushing, and mild electrical stimuli to different parts of their body. Participants will rank how each stimulus feels using a scale with numbers or a scale with faces.... Type: Interventional Start Date: Mar 2026 |
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Top-Down Attentional Control of Visual-Processing
National Institute of Mental Health (NIMH)
Focal Brain Lesion
Focal Lesions
fMRI
Background:
- Previous studies have shown that people with certain types of brain damage may have
particular problems paying attention and processing things that they see. Researchers are
interested in comparing how people with brain damage and without brain damage process
visual images.
Objectiv1 expand
Background: - Previous studies have shown that people with certain types of brain damage may have particular problems paying attention and processing things that they see. Researchers are interested in comparing how people with brain damage and without brain damage process visual images. Objectives: - To better understand the areas of the brain involved in paying attention to things that are seen. Eligibility: - Individuals at least 18 years of age who either have had damage to one or both sides of specific parts of the brain (e.g., stroke, injury, certain neurosurgery procedures) or are healthy volunteers. Design: - The study involves 4 to 10 visits to the NIH Clinical Center over 1 to 2 years. Each visit will last approximately 2 hours. - Participants will be screened with a medical history and physical examination, and may have the cognitive testing described below during the same visit. - On the first visit and for at least one visit thereafter, participants will have cognitive testing to evaluate thinking and memory. These tests will be either written tests or computer-based tests. - Some participants will qualify for functional magnetic resonance imaging (fMRI) as part of the study. This part will involve a decision-making task that will be performed on a computer during the fMRI scan. Additional scans may be required as directed by the study doctors. - Some randomly selected participants will be asked to have magnetoencephalography (MEG), a procedure to record very small magnetic field changes produced by brain activity. - During the behavioral training, or fMRI or MEG scanning, participants may be monitored with equipment to track eye movements. Type: Observational Start Date: Jul 2012 |
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Noninvasive Pre-surgical Evaluation of Patients With Focal Epilepsy and Establishment of a Normativ1
National Institute of Neurological Disorders and Stroke (NINDS)
Epilepsy
Objectives:
The overall study objective is to compare the sensitivities and specificities of
morphometric analysis techniques using structural MRI images based on pre- and
postsurgical localization of epileptic foci in patients undergoing presurgical evaluation
for medically refractory epilepsy. T1 expand
Objectives: The overall study objective is to compare the sensitivities and specificities of morphometric analysis techniques using structural MRI images based on pre- and postsurgical localization of epileptic foci in patients undergoing presurgical evaluation for medically refractory epilepsy. To carry out these analyses, we aim to establish an age-stratified normative imaging database using healthy volunteers. Additional objectives are to identify abnormal networks in these patients using resting state fMRI/EEG and MEG/EEG, and to use language and memory fMRI tasks to examine the effects of epileptogenic zones and surgery on cognitive function and the networks associated with these functions. Study population: 300 adults and children (age 8 and older) with uncontrolled focal epilepsy, and 200 age-stratified healthy volunteers. Design: A retrospective and prospective natural history study. Research procedures for patients in this study include neuropsychological testing and 1-4 MRI sessions during presurgical evaluation and an additional 1-3 MRI sessions and neuropsychological testing approximately 12 months post-operatively. Research testing (such as research neuropsychological tests or MRI scanning sequences) will be done during a visit for clinical testing whenever possible, likely reducing the number of required visits. Patients will also have optional MEG and 7T structural imaging. Data will also be obtained from patients who have already undergone epilepsy surgery if they had procedures as outlined in the protocol and are willing to share the data. Healthy volunteers will receive a subset of the pre-operative procedures for patients, requiring at least 3 visits. In order to ensure adequate data acquisition, subjects may be re-scanned up to three times for the portions of the study in which they participated, possibly requiring additional visits. Outcome measures: The main outcomes will be establishment of normative values for morphometric analysis methods in age-stratified normal controls, and comparison of the sensitivity and specificity of these measures to pre- and postsurgical localization of the epileptogenic zone. Secondary outcome measures will include determination of the sensitivity and specificity of source localization using MEG/EEG and resting state fMRI/EEG, and to evaluate changes in activation during rest, as well as language and memory fMRI tasks in patients pre- and postsurgically, to examine the effects of epileptogenic zones and surgery on cognitive function and the networks underlying these functions. Type: Observational Start Date: Mar 2014 |
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Partial Stem Cell Transplant for Sickle Cell Disease From Matched Donors
National Heart, Lung, and Blood Institute (NHLBI)
Sickle Cell Disease
Beta-thalassemia
This is a non-ablative (partial) stem cell transplant for patients with severe sickle
cell disease or beta-thalassemia requiring red cell transfusions. The intensity of the
transplant is slightly increased from our previous transplant regimens. The goal is to
aim for higher percentage of donor cell1 expand
This is a non-ablative (partial) stem cell transplant for patients with severe sickle cell disease or beta-thalassemia requiring red cell transfusions. The intensity of the transplant is slightly increased from our previous transplant regimens. The goal is to aim for higher percentage of donor cells to stably remain in the recipients long term. Type: Interventional Start Date: Jul 2026 |
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Predicting Future Errors During Skill Performance
National Institute of Neurological Disorders and Stroke (NINDS)
Healthy
Background:
Many tasks people do every day require a series of individual movements. Control over
these movements is called motor skills. But even highly skilled people can make mistakes.
Researchers have found that they can predict when a person will make a mistake 0.1 second
before it happens. N1 expand
Background: Many tasks people do every day require a series of individual movements. Control over these movements is called motor skills. But even highly skilled people can make mistakes. Researchers have found that they can predict when a person will make a mistake 0.1 second before it happens. Now, they want to find out if they can increase that time up to 1 second-long enough to warn the person and prevent the mistake. Objective: To see if motor skill errors can be detected up to 1 second before they occur. Eligibility: Right-handed healthy adults aged 18 to 35. Design: Participants will have 2 to 5 study visits. Each visit will be 1 to 2 hours. They will have a physical and neurological exam. They will have 1 or 2 magnetic resonance imaging (MRI) scans. They will lie on a table that slides into a large cylinder. The MRI uses strong magnets to capture images of the inside of the body, including the brain. They will have another scan, called magnetoencephalography (MEG). Small metal disks attached to wires will be taped to their head. Participants will sit in a padded chair with their head inside of a helmet. The helmet will not cover their eyes or face. Participants will perform a series of typing tasks on a keyboard. They will have short breaks between each round. Their head movements will be tracked, and their eye and finger movements will be videotaped. Type: Observational Start Date: Jun 2026 |
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Androgen Receptor, Implications for Health and Wellbeing: Natural History Study of Individuals With1
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Androgen Insensitivity Syndrome
Metabolic Parameters in AIS, CAIS, PAIS and MAIS
Tumor Formation in AIS, CAIS, PAIS and MAIS
Sexual Function AIS, CAIS, PAIS and MAIS
Background:
Androgen effects in humans are usually (but not always) mediated by the androgen receptor
which is coded for by the androgen receptor gene (AR gene). Androgen Insensitivity
Syndrome (AIS) is a rare condition in which the body cannot sense the male hormones in
the blood or tissue. Both1 expand
Background: Androgen effects in humans are usually (but not always) mediated by the androgen receptor which is coded for by the androgen receptor gene (AR gene). Androgen Insensitivity Syndrome (AIS) is a rare condition in which the body cannot sense the male hormones in the blood or tissue. Both women and men can be affected by AIS. Researchers want to learn more about the health of people with AIS over time. With a natural history study in individuals with AIS, data and tests may provide information regarding health risks (including the risks and benefits of gonadectomy and best ways to monitor for tumor) and optimal management of individuals with AIS as well as elucidate the role of the androgen receptor in human health. This study does not involve any interventions and we can provide clinical care while collecting data. Objective: The objective of this natural history study is to describe and define a comprehensive phenotype (characteristic) of patients with AIS based on confirmed androgen receptor (AR) gene difference. We will evaluate hormones, bone density and markers, cardiovascular and metabolic parameters, as well as quality of life and tumor formation risk and evaluation. The purpose is to obtain a better understanding of the overall health issues that people with AIS may have through the study procedures listed. Eligibility: People ages 8-99 with AIS and their adult relatives Design: Participants will go through a series of study procedures for data and specimen collection. This will be done to understand how AIS affects individuals since the androgen receptor is found in many tissues in the body including skin, bone, muscle, and the neurologic, immune and metabolic systems. All tests will be performed by skilled and trained study professionals. Participants will be screened with: Medical history Physical exam Medical record review Lab tests. Participants will have physical exams. Their body measurements will be taken. They will have blood and urine tests. They will have electrocardiograms to check heart health. They may complete questionnaires. They may have an Oral Glucose Tolerance Test. Participants may have x-rays and HRpQCT scans taken of the hand, wrist, and other bones. Participants will have body scans to measure bone thickness. Participants will have magnetic resonance imaging (MRI) or sonogram of the pelvis. For MRI, they may get a contrast agent via intravenous (IV) catheter. Adult participants may have the following: MR elastography. It uses MRI and low-frequency vibrations to map stiffness of body tissues. MR spectroscopy. It uses MRI to take pictures of chemicals in the liver and body fat. Cardiac computed tomography scan. It uses x-rays to make pictures of the heart. Participants may get a contrast agent via IV. Optional genital exam. Optional one-time vaginal swab. Participants will have visits every 1-2 years. Participation lasts indefinitely. Adult relatives will also be invited to participate but will have only 1 visit. It will include some of the above tests. Type: Observational Start Date: Apr 2021 |
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Evaluation of Adults With Endocrine and Metabolic-Related Conditions
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Endocrine Diseases
Background:
There are many endocrine and metabolic-related conditions. Two well-known disorders
include diabetes and thyroid disease. Some of these diseases are caused by a change in
genes. Researchers want to identify the genes involved in these disorders. They hope this
will help them learn more1 expand
Background: There are many endocrine and metabolic-related conditions. Two well-known disorders include diabetes and thyroid disease. Some of these diseases are caused by a change in genes. Researchers want to identify the genes involved in these disorders. They hope this will help them learn more about these diseases. Objectives: To learn more about conditions that affect the hormone-secreting glands (endocrine glands) in adults. To train doctors to diagnose and treat people with endocrine or metabolic conditions. Eligibility: Adults age 18 years and older with a known or suspected endocrine disorder. Relatives ages 18 years and older. Doctors will review all requests and available medical records to determine final eligibility for the protocol. Design: Participants will have a medical history and physical exam. Most participants will have 1 visit, and may have follow up visits if necessary. They may have tests, surgery, or other procedures to help diagnose or treat their condition. These could include: - Blood, urine, and saliva tests - Imaging tests. These may include X-ray, ultrasound, or scans. - Sleep study - Medical photographs - Visits with other specialists at NIH Participants will provide blood, urine, saliva, or tissue samples. Some of these samples may be stored in the freezer for future studies. Participants may be asked to participate in genetic testing. They will give a blood or saliva sample for this. Type: Observational Start Date: Jul 2016 |
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Tissue Collection for Studies of Lymph Cancer
National Cancer Institute (NCI)
Hodgkin Disease
Lymphoma, Non-Hodgkin
Multiple Myeloma
Lymphomatoid Granulomatosis
Leukemia-Lymphoma, Adult T-Cell
Background:
- Lab studies help researchers better understand cancer biology. This information may
lead to new methods for diagnosing or treating cancer. To develop these studies,
researchers want to collect samples from people with cancer or precancer conditions of
the lymph system. These conditio1 expand
Background: - Lab studies help researchers better understand cancer biology. This information may lead to new methods for diagnosing or treating cancer. To develop these studies, researchers want to collect samples from people with cancer or precancer conditions of the lymph system. These conditions include multiple myeloma, different types of lymphoma, and adult leukemia/lymphoma. The samples collected will include blood, urine, bone marrow, and tumor and skin tissue. Objectives: - To collect tissue samples to study different types of lymph cancer. Eligibility: - Individuals at least 18 years of age who have a lymphoid cancer or precancer condition. Design: - Participants will be screened with a physical exam and medical history. - Different samples will be collected for study. Blood samples will be collected at the initial testing. More blood samples will be collected at different treatment points. Other liquid samples include urine, bone marrow, and any abnormal fluid. Tumor tissue and skin tissue biopsies will also be collected for study. - Treatment will not be provided as part of this study. Type: Observational Start Date: Sep 2012 |
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Evaluation of Patients With Immune Function Abnormalities
National Institute of Allergy and Infectious Diseases (NIAID)
Chronic Granulomatous Disease (CGD)
X-Linked Severe Combined Immune Deficiency (XSCID)
Leukocyte Adhesion Deficiency 1 (LAD)
Graft Versus Host Disease (cGvHD)
This study will evaluate patients with abnormal immune function that results in recurrent
or unusual infections or chronic inflammation. This may include inherited conditions,
such as X-linked severe combined immunodeficiency (XSCID), chronic granulomatous disease
(CGD), and leukocyte adhesion defi1 expand
This study will evaluate patients with abnormal immune function that results in recurrent or unusual infections or chronic inflammation. This may include inherited conditions, such as X-linked severe combined immunodeficiency (XSCID), chronic granulomatous disease (CGD), and leukocyte adhesion deficiency (LAD), or conditions resulting from outside factors, such as graft-versus-host disease (GVHD). The information from this study will be used to establish the pattern and pace of change of the disease and to help develop new treatments. The period of observation and study following enrollment in this study may be for up to one year. In addition these studies may provide the medical information needed to determine eligibility for enrollment in other clinical study protocols and more prolonged follow up. Patients of any age with abnormal immune function who have recurrent or unusual infections, whose blood tests show evidence of immune dysfunction, or who have GVHD, XSCID, CGD or LAD may be eligible for this study. Patients' parents, siblings, grandparents, children, aunts, uncles and first cousins of any age also may be included. Healthy normal volunteers between 18 and 85 years of age are recruited as controls. Normal volunteers undergo a physical examination and provide blood, saliva, and urine samples for immune function studies. Patients' family members provide a medical history, have a physical examination, and give blood and urine samples, and possibly a saliva sample. The samples are used for genetic and routine laboratory studies. Investigators may request tissue samples, such as biopsy specimens, previously removed for medical reasons to be sent to NIH for study. Patients undergo the following tests and procedures: 1. Medical history and physical examination. 2. Blood and urine tests, including analysis for genes involved in immune disorders. 3. Buccal smear (in some patients) for genetic studies. This involves scraping the lining of the mouth near the cheek. 4. Specialized tests to evaluate specific conditions in patients who have an immune disorder that might affect lung function, gum infections or eye problems. These may include chest x-ray, CT scan, breathing function test, dental, eye, and hearing examinations. 5. Follow-up visits of patients with immune problems may occur at 6 months and at one year after the first visit (or more frequently if medically required) to include: - Medical history update - Physical examination - Follow-up on abnormal test results and medical treatments initiated at NIH - Collection of blood, saliva, urine, or wound drainage samples for repeat immune function studies - Tissue study of specimens removed for medical reasons at other institutions besides NIH Type: Observational Start Date: Sep 2005 |
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Thrombosis and Inflammation in Vessels Initiative (TIVI)
National Heart, Lung, and Blood Institute (NHLBI)
Cardiovascular Diseases
Vascular Diseases
Background:
Diseases related to the immune system, blood clots, and blood vessels can affect every
part of the body. These diseases are now known to be interrelated: People who have
strokes, blood clots in their legs, or autoimmune disease, for example, are at greater
risk of complications in the1 expand
Background: Diseases related to the immune system, blood clots, and blood vessels can affect every part of the body. These diseases are now known to be interrelated: People who have strokes, blood clots in their legs, or autoimmune disease, for example, are at greater risk of complications in the heart, brain, and other organs. Researchers want to learn more about how these diseases start, how they change over time, and how they affect different organs. Objective: To learn more about how inflammation and diseases of the blood vessels start and how they change over time. Eligibility: People aged 5 years and older with a disease related to blood clots, the immune system, or blood vessels. Healthy relatives of people with these diseases and unrelated healthy volunteers are also needed. Design: Participants will have a baseline visit: They will provide a medical history, physical exam and blood test. All other tests and procedures are optional; these may be spread over more than 1 day: Tests of heart and lung function. Fill in a family tree form. Imaging scans Treadmill or bike stress tests and a 6-minute walk test. Tests of blood pressure and the flow of blood through vessels. Photos of the face and body. Eye exams, with photos taken of the retina. Saliva and urine samples. Biopsies (tissues samples) of the skin and fat. Tests of thinking and mental function. Evaluations by other medical specialists. Participants may opt to return for repeat testing for up to 90 months (7.5 years). Some visits may be done by telehealth. Type: Observational Start Date: Nov 2024 |
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Diagnosis and Treatment of Leishmania Infections
National Institute of Allergy and Infectious Diseases (NIAID)
Leishmaniasis
Skin Diseases, Parasitic
Euglenozoa Infections
Parasitic Diseases
This study will examine the natural history of Leishmanial infections and their
treatments. It will provide an opportunity for NIAID staff to learn more about
leishmaniasis and perhaps to improve diagnostic tests for these infections. Patients
between 2 and 80 years of age with known or suspected l1 expand
This study will examine the natural history of Leishmanial infections and their treatments. It will provide an opportunity for NIAID staff to learn more about leishmaniasis and perhaps to improve diagnostic tests for these infections. Patients between 2 and 80 years of age with known or suspected leishmaniasis are eligible for this study. Participants will have routine blood tests and a biopsy to confirm leishmanial infection. The biopsy procedure will be determined by the type of infection local cutaneous leishmaniasis (LCL), mucocutaneous leishmaniasis (MCL) or visceral leishmaniasis (VL). CL will be confirmed with a punch biopsy, in which a cookie-cutter type razor is used to remove a small circular piece of skin tissue. MCL will be confirmed using a thin flexible tube inserted into the nose. This tube is used to examine the nose and upper airway and to remove a tissue sample, if an affected area is seen. VL will be confirmed with either a bone marrow or liver biopsy or a splenic aspirate. For these procedures, a small tissue sample is withdrawn through a needle placed in the hipbone, liver or spleen, respectively. Some patients may also have a skin test for leishmaniasis similar to tuberculin skin testing. Treatment and length of hospital stay are determined by the type of infection. CL may be treated with Pentostam, amphotericin, amphotericin B, itraconazole or ketoconazole; ML with amphotericin B, or encapsulated amphotericin; and VL with Pentostam or encapsulated amphotericin. Pentostam is infused daily for 18 to 28 doses, most as an outpatient. Blood is drawn 3 times a week for safety tests and an electrocardiogram is done 2 to 3 times a week to monitor heart rhythm. Amphotericin B is infused every day or every other day for about 30 doses, all on an inpatient basis. Patients undergo hydration (infusion of a large amount of fluid) just before and immediately after each infusion to protect the kidneys. Blood is drawn every other day and urine samples are collected occasionally for routine urinalysis. Encapsulated amphotericin is infused every other day, on an outpatient basis. Blood is generally drawn every other day to every 2 days and urinalyses are done periodically. Itraconazole and ketoconazole are taken orally for at least 1 to 3 months, with blood drawn every 2 to 3 weeks. Patients may be asked to have photographs taken before, during and after treatment to document progress. They may also be asked to provide extra blood samples for research purposes, either through a vein in the arm or through apheresis, a method for collecting large numbers of cells. For apheresis, whole blood is collected through a needle in an arm vein and circulated through a machine that separates it into its components. The desired cells are then removed, and the rest of the blood is returned to the body, either through the same needle used to draw the blood or through a second needle in the other arm. Patients with cutaneous leishmaniasis will have a follow-up clinic visit 2 weeks to 3 months after treatment is completed. If there are no complications, their participation will end at that time. Patients with mucocutaneous leishmaniasis and visceral leishmaniasis will be followed every 3 to 6 months indefinitely for routine evaluations and re-treatment if the infection recurs. Type: Observational Start Date: Nov 2001 |
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PET Imaging of Phosphodiesterase-4B (PDE4B) in Alcohol Use Disorder
National Institute of Mental Health (NIMH)
Alcohol Use Disorder
Background:
People with alcohol use disorder (AUD) also often have bouts of depression called major
depressive episodes (MDEs). People having MDEs have been found to have low levels of a
protein called PDE4B in the brain. Researchers want to find out if people with AUD also
have low levels of PDE41 expand
Background: People with alcohol use disorder (AUD) also often have bouts of depression called major depressive episodes (MDEs). People having MDEs have been found to have low levels of a protein called PDE4B in the brain. Researchers want to find out if people with AUD also have low levels of PDE4B. This research may help lead to better treatments for AUD. Objective: To find out (1) if PDE4B levels are lower in people who are withdrawing from AUD and (2) if their PDE4B levels go up after they abstain from alcohol for 3 to 4 weeks. Eligibility: Adults aged 18 to 70 years with AUD. They must be enrolled in protocol 14-AA-0181. Design: Participants enrolled in protocol 14-AA-0181 will stay in the clinic for 3 to 4 weeks for alcohol withdrawal. During this stay, they will have some added procedures for the current study. Within the first week, participants will have a positron emission tomography (PET) scan of the brain. A needle will be used to guide a thin plastic tube (catheter) into a vein in one arm. An experimental substance called a radioactive tracer will be injected through the catheter. This tracer binds to PDE4B and makes it easier to see the protein in the brain. For the scan, participants will lie on a table that slides into a doughnut-shaped machine. Participants will have a second PET scan toward the end of their stay in the clinic. Participants may also have a magnetic resonance imaging (MRI) scan of the brain. They will lie on a bed that slides into a tube.... Type: Interventional Start Date: Mar 2025 |
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Study to Evaluate the Safety and Tolerability of Escalating Doses of Fostamatinib in Subjects With1
National Heart, Lung, and Blood Institute (NHLBI)
Sickle Cell Disease
Hb-SS Disease
Hemoglobin S
Disease Sickle Cell Anemia
Sickle Cell Disorders
Background:
Sickle cell disease (SCD) is a genetic disease that causes the body to produce abnormal (
sickled ) red blood cells. SCD can cause anemia and life-threatening complications in the
lungs, heart, kidney, and nerves. People with SCD are also at increased risk of forming
blood clots in the1 expand
Background: Sickle cell disease (SCD) is a genetic disease that causes the body to produce abnormal ( sickled ) red blood cells. SCD can cause anemia and life-threatening complications in the lungs, heart, kidney, and nerves. People with SCD are also at increased risk of forming blood clots in the veins and lungs, but the standard treatments for these clots can cause increased bleeding in people with SCD. Better treatments are needed. Objective: To test a drug (fostamatinib) in people with SCD. Eligibility: People aged 18 to 65 with SCD. Design: Participants will have 6 clinic visits over 12 weeks. Each visit will be 2 to 3 hours. Participants will be screened. They will have a physical exam with blood tests. They will tell the researchers about the medications they take. Fostamatinib is a tablet taken by mouth. Participants will take the drug at home, twice a day, for up to 6 weeks. Participants will have a clinic visit every 2 weeks while they are taking the drug. At each visit they will have a physical exam with blood tests. They will talk about any side effects the drug may be causing. If they are tolerating the drug well after the first 2 weeks, they may begin taking a higher dose. Participants will have a final visit 4 weeks after they stop taking the drug. They will have a physical exam and blood tests; they will be checked for any side effects of the drug. Type: Interventional Start Date: Dec 2024 |
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Clinical and Genetic Studies of Li-Fraumeni Syndrome
National Cancer Institute (NCI)
Li-Fraumeni Syndrome
Neoplasms
Tp53 Mutations
Background:
- Li-Fraumeni syndrome (LFS) is a genetic condition that increases the risk for some
types of cancer. LFS may lead to cancer of the bone or connective tissue, breast, and
brain. It may also increase the risk for certain types of leukemia and other cancers. The
only known cause of LFS i1 expand
Background: - Li-Fraumeni syndrome (LFS) is a genetic condition that increases the risk for some types of cancer. LFS may lead to cancer of the bone or connective tissue, breast, and brain. It may also increase the risk for certain types of leukemia and other cancers. The only known cause of LFS is a change (called a mutation ) in a gene known as TP53. However, not all people with LFS have a TP53 mutation. Researchers want to study other possible genetic causes of LFS, and factors that may increase or decrease cancer risk in people with the syndrome. Objectives: - To learn more about the types of cancers that occur in individuals with LFS. - To study the role of the TP53 gene in the development of cancer. - To look for other possible genes that cause LFS - To study the effect of LFS diagnosis on families. - To determine if environmental factors or other genes can change a person s cancer risk associated with LFS. Eligibility: - Individuals with a family or personal medical history of cancers consistent with LFS. - Individuals with a family or personal medical history of cancers that does not meet the diagnosis of LFS, but the history is suggestive for LFS (meets the diagnosis for the so-called Li-Fraumeni like syndrome) - Individuals with certain rare cancers - Individuals with a family or personal history of a TP53 gene mutation, with or without related cancer(s). Design: - Participants will fill out a medical history questionnaire and a family history questionnaire. - Blood samples will be collected for DNA and for storage. Cheek cell samples may be collected if blood cannot be obtained for DNA. Participants can choose to have or not have cancer screening with blood tests, imaging studies, and other exams. - Participants will complete questionnaires about their worries about cancer, stress levels, and coping strategies. Diet and physical activity questionnaires will also be given. Other psychological tests may be given as needed. - Participants will be monitored for several years, with regular followup visits to the National Institutes of Health, if indicated. Any changes in health or cancer status will be recorded. Type: Observational Start Date: Jan 2012 |
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Aromatherapy and Music Impact on Nurses' Stress at Work
Northwestern University
Stress
The purpose of the Doctor of Nursing Practice research project is to determine if nurses
who receive chamomile-lavender aromatherapy and listen to music during a 20-minute break
once per shift for 8 weeks, will experience report decreased work stress (measured by
self-reported symptoms of anxiety)1 expand
The purpose of the Doctor of Nursing Practice research project is to determine if nurses who receive chamomile-lavender aromatherapy and listen to music during a 20-minute break once per shift for 8 weeks, will experience report decreased work stress (measured by self-reported symptoms of anxiety) compared to before the aromatherapy and music intervention during breaks. We know nurses are at high risk for stress and anxiety. Despite the current processes and policies in place at Northwestern Memorial Hospital that support nurses to take breaks during their shifts, nurses continue to share feeling stressed and anxious. Included in this Doctor of Nursing Practice research project is an evidence synthesis of fourteen studies supporting the idea that combining aromatherapy and music can reduce anxiety in both adults and children. The evidence-based intervention being studied is administering lavender-chamomile essential oil aromatherapy and listening to music during 20-minute non-meal breaks once a shift for 8 weeks. Participants will go to a quiet breakroom, pour 3 drops of lavender-chamomile essential oil onto a non-adhesive 2X2 gauze pad, and place the pad about 20 centimeters from their noses while also listening to their preferred calming music through their personal phones and wireless earbuds or headphones for twenty minutes. Type: Interventional Start Date: Jul 2026 |
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Assessing the Mechanisms and Impact of a Novel Cannabinoid Product for Gynecologic Pain
Staci Gruber, Ph.D.
Endometriosis
Adenomyosis
Chronic Pelvic Inflammatory Disease
Despite recent increases in both medical and recreational cannabis use in the United
States and globally, little research has been conducted to determine the potential
applications for womens health. A variety of medical cannabis and hemp-derived products
on the marketplace claim to hold efficacy f1 expand
Despite recent increases in both medical and recreational cannabis use in the United States and globally, little research has been conducted to determine the potential applications for womens health. A variety of medical cannabis and hemp-derived products on the marketplace claim to hold efficacy for many womens health-related conditions, including gynecologic pain. This 7-day study of individuals living with endometriosis, adenomyosis, or chronic pelvic inflammatory disease (PID), will identify specific targets and mechanisms underlying the potential impact of a hemp-derived, full-spectrum, high-CBD product in individuals with gynecologic pain. Type: Interventional Start Date: Sep 2026 |
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PCOS and Brain Health
University of Wisconsin, Madison
PCOS
The purpose of this study is to determine how polycystic ovary syndrome (PCOS) impacts
overall brain health, such as cerebral blood flow (CBF), brain structure and
connectivity, and cognitive performance. 45 reproductive aged (18-45 years) individuals
with ovaries, with and without PCOS, will be en1 expand
The purpose of this study is to determine how polycystic ovary syndrome (PCOS) impacts overall brain health, such as cerebral blood flow (CBF), brain structure and connectivity, and cognitive performance. 45 reproductive aged (18-45 years) individuals with ovaries, with and without PCOS, will be enrolled to complete brain structure and CBF scans via magnetic resonance imaging (MRI) over 2 testing visits and can expect to be on study for approximately 5 hours over a 1 to 3 month period. Type: Observational Start Date: Aug 2026 |
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Transventricular Off-pump Mitral Valve Repair
Johns Hopkins University
Mitral Valve (MV) Regurgitation
The purpose of this study is to assess the safety and effectiveness (usefulness) of an
investigational technique used to repair the mitral valve for patients with mitral
regurgitation due to a defective valve leaflet. This procedure is called
trans-ventricular off-pump mitral valve repair (TRANSOM)1 expand
The purpose of this study is to assess the safety and effectiveness (usefulness) of an investigational technique used to repair the mitral valve for patients with mitral regurgitation due to a defective valve leaflet. This procedure is called trans-ventricular off-pump mitral valve repair (TRANSOM) and it repairs the mitral valve by replacing some of the cords that support the mitral valve. This type of repair is minimally-invasive since it is performed through a small incision and avoids making a breast-bone-splitting incision. Type: Interventional Start Date: Jun 2026 |
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A Study to Assess the Efficacy, Safety and Tolerability of AT673 Co-administered With Semaglutide i1
Antag Therapeutics
Adults With Overweight/Obesity and Type 2 Diabetes
The goal of this clinical trial is to learn if AT673 contributes to additional weight
loss and glycemic control when given with semaglutide in participants with
overweight/obesity and type 2 diabetes. The main questions it aims to answer are:
- To compare the effect on body weight of two doses1 expand
The goal of this clinical trial is to learn if AT673 contributes to additional weight loss and glycemic control when given with semaglutide in participants with overweight/obesity and type 2 diabetes. The main questions it aims to answer are: - To compare the effect on body weight of two doses of AT673 once-weekly versus matched placebo when concurrently administered with semaglutide once-weekly - To evaluate the effect of AT673 on glycated hemoglobin (HbA1c) - To compare the safety and tolerability of AT673 versus matched placebo when concurrently administered with semaglutide Type: Interventional Start Date: Jun 2026 |
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Social Media Influences on Engagement and Susceptibility to Non-combustible Tobacco Product Use Amo1
University of Southern California
Perceptions of Tobacco Products
The purpose of this study is to present social media posts with varying combinations of
flavor types and mentions of stealth use, to adolescents and determine whether these
message characteristics increase adolescents' perceptions of these products and
susceptibility to using these products. expand
The purpose of this study is to present social media posts with varying combinations of flavor types and mentions of stealth use, to adolescents and determine whether these message characteristics increase adolescents' perceptions of these products and susceptibility to using these products. Type: Interventional Start Date: Jul 2025 |
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IM ABLE 2: Injuries Managed With Advanced Bracing for Lower Extremities
University of South Florida
Lower Limb Injury
Ankle Foot Orthosis (AFO)
Lower Limb Trauma
The purpose of the study is to test different categories of ankle foot orthoses (AFOs)
with patients who have had lower limb salvage, reconstruction or other problems impacting
limb function. expand
The purpose of the study is to test different categories of ankle foot orthoses (AFOs) with patients who have had lower limb salvage, reconstruction or other problems impacting limb function. Type: Interventional Start Date: Jul 2026 |
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Acute Effects of Neurodynamics on Strength and Endurance in Athletes
High Point University
Sciatic Leg Pain
Hamstring Muscle Tightness
Hamstring Muscle Strain
Hamstring Muscle Strength
Hamstring Injuries
This study explores the acute effects of neurodynamics, an intervention commonly used by
physical therapist to improve nerve mobility and decrease pain, on the strength and
muscular endurance in the athletic population. This study aims to find if these
interventions can maintain or promote strength1 expand
This study explores the acute effects of neurodynamics, an intervention commonly used by physical therapist to improve nerve mobility and decrease pain, on the strength and muscular endurance in the athletic population. This study aims to find if these interventions can maintain or promote strength and endurance in the hamstrings. The studies results will help physical therapist better prescribe exercise and hands-on treatment for hamstring and sciatic nerve related conditions and injuries. Type: Interventional Start Date: Jun 2026 |