
Search Clinical Trials
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CD19/CD22 Bicistronic Chimeric Antigen Receptor (CAR) T Cells in Children and Young Adults With Rec1
National Cancer Institute (NCI)
B-NHL
B-Non Hodgkin Lymphoma
Acute Lymphocytic Leukemia
Acute Lymphoblastic Leukemia
B-precursor ALL
Background:
Acute lymphoblastic leukemia (ALL) is the most common cancer in children. About 90% of
children and young adults who are treated for ALL can now be cured. But if the disease
comes back, the survival rate drops to less than 50%. Better treatments are needed for
ALL relapses.
Objective:1 expand
Background: Acute lymphoblastic leukemia (ALL) is the most common cancer in children. About 90% of children and young adults who are treated for ALL can now be cured. But if the disease comes back, the survival rate drops to less than 50%. Better treatments are needed for ALL relapses. Objective: To test chimeric antigen receptor (CAR) therapy. CARs are genetically modified cells created from each patient s own blood cells. his trial will use a new type of CAR T-cell that is targeting both CD19 and CD22 at the same time. CD19 and CD22 are proteins found on the surface of most types of ALL. Eligibility: People aged 3 to 39 with ALL or related B-cell lymphoma that has not been cured by standard therapy. Design: Participants will be screened. This will include: Physical exam Blood and urine tests Tests of their lung and heart function Imaging scans Bone marrow biopsy. A large needle will be inserted into the body to draw some tissues from the interior of a bone. Lumbar puncture. A needle will be inserted into the lower back to draw fluid from the area around the spinal cord. Participants will undergo apheresis. Their blood will circulate through a machine that separates blood into different parts. The portion containing T cells will be collected; the remaining cells and fluids will be returned to the body. The T cells will be changed in a laboratory to make them better at fighting cancer cells. Participants will receive chemotherapy starting 4 or 5 days before the CAR treatment. Participants will be admitted to the hospital. Their own modified T cells will be returned to their body. Participants will visit the clinic 2 times a week for 28 days after treatment. Follow-up will continue for 15 years.... Type: Interventional Start Date: Dec 2022 |
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Teriflunomide in HTLV-1 Associated Myelopathy/Tropical Spastic Paraparesis
National Institute of Neurological Disorders and Stroke (NINDS)
HAM/TSP
Background:
HTLV-1 associated myelopathy/tropical spastic paraparesis (HAM/TSP) is a rare,
progressive disease. It occurs in some people infected with the HTLV-1 virus. It leads to
weakness in the lower limbs and other serious problems. It has no treatment.
Teriflunomide is a drug used to treat mu1 expand
Background: HTLV-1 associated myelopathy/tropical spastic paraparesis (HAM/TSP) is a rare, progressive disease. It occurs in some people infected with the HTLV-1 virus. It leads to weakness in the lower limbs and other serious problems. It has no treatment. Teriflunomide is a drug used to treat multiple sclerosis. It reduces immune cells that make the disease worse. Researchers want to learn if this drug can help people with HAM/TSP. Objective: To learn the effects, immune response, safety, and tolerability of teriflunomide in people with HAM/TSP. Eligibility: Adults ages 18 and older with HAM/TSP. Design: Participants will be screened under protocol 98-N-0047. Participants will have a medical history. They will have physical and neurological exams. They will have blood and urine tests. Participants will take 1 tablet of the study drug once a day for 9 months. They will keep a drug diary. Participants will have lymphapheresis. For this, blood is drawn from a needle in one arm. A machine divides the blood into red cells, plasma, and white cells. The white cells are removed. The plasma and red cells are returned to the participant through a needle in the other arm. Participants will have lumbar punctures ( spinal taps ). For this, a thin needle is inserted into the spinal canal in the lower back. Spinal fluid is removed. Participants will have magnetic resonance imaging (MRI) of the brain and spine. The MRI scanner is a metal cylinder surrounded by a strong magnetic field. During the MRI, participants will lie on a table that can slide in and out of the scanner. Participation will last for 15 months. Type: Interventional Start Date: Sep 2021 |
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Phase 1 Study of Ibrutinib and Immuno-Chemotherapy Using Temozolomide, Etoposide, Doxil, Dexamethas1
National Cancer Institute (NCI)
Primary Central Nervous System Lymphoma
BACKGROUND:
- Primary CNS lymphoma (PCNSL) is a rare subtype of diffuse large B-cell lymphoma.
- The outcome for patients with this diagnosis is significantly worse than for that of
systemic DLBCL. Most treatment approaches in the past have included high dose
methotrexate and radi1 expand
BACKGROUND: - Primary CNS lymphoma (PCNSL) is a rare subtype of diffuse large B-cell lymphoma. - The outcome for patients with this diagnosis is significantly worse than for that of systemic DLBCL. Most treatment approaches in the past have included high dose methotrexate and radiation treatment. - Most PCNSLs appear to be of activated B-cell (ABC) origin. - Ibrutinib is an inhibitor of Bruton s tyrosine kinase (BTK) and effective for systemic DLBCL of ABC origin. - We propose doing a study in which ibrutinib is combined with a novel chemotherapy platform called dose adjusted temozolomide, etoposide, doxil, dexamethasone, ibrutinib, rituximab (TEDDI-R). OBJECTIVE: - Identify the maximum tolerated dose (MTD) of ibrutinib or the dose that achieves adequate CSF concentrations, whichever comes first, when ibrutinib is given with TEDDI-R. ELIGIBILITY: - Relapsed/refractory PCNSL. - Age greater than or equal to 18 years. - No pregnant or breast-feeding women. - Adequate organ function (defined in protocol). STUDY DESIGN: - This is a phase 1 study of 40 patients. - The study will have two components. 1. Phase 1: MTD of ibrutinib will be identified or the dose at which ibrutinib achieves a concentration of less than or equal to 100 nM in the CSF, when given in combination with TEDDI-R immuno-chemotherapy, whichever comes first. 2. Expansion cohort: Safety and tolerability of the regimen in relapsed/refractory or previously untreated PCNSL (DLBCL type) will be assessed at the final ibrutinib dose with TEDDI-R in 10 patients. Secondary objectives will be PFS and OS. Type: Interventional Start Date: Aug 2014 |
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Data Collection of Standard Care of Patients in the EMG Section
National Institute of Neurological Disorders and Stroke (NINDS)
Neuropathy
Muscle Disorders
Dysautonomia
Background:
Most people who are referred to the EMG (Electromyography) Section of the NIH are
enrolled into specific active studies. This allows researchers to learn about a range of
rare neuromuscular disorders. But study criteria may not give researchers the chance to
evaluate a single person or1 expand
Background: Most people who are referred to the EMG (Electromyography) Section of the NIH are enrolled into specific active studies. This allows researchers to learn about a range of rare neuromuscular disorders. But study criteria may not give researchers the chance to evaluate a single person or study a common symptom. Therefore, researchers want to assess people with neuromuscular disorders who are not currently enrolled in any NIH studies. They will perform tests on these individuals in the EMG Lab. Then they will create a repository of data that may be used for future research. This will help them learn more about these disorders. Objective: To retain data that is collected as part of participant visits to the NIH. Eligibility: People aged 18 and older who will be visiting the NIH for evaluation of their neuromuscular disorder. Design: Participants will be screened with a medical record review. Participants will have a physical exam. They will be evaluated for their neuromuscular disorder. They may have tests to learn more about how their nerves and muscles work that are called nerve conduction and EMG studies. Their muscles and nerves may be assessed with an ultrasound. Their ability to sweat may be measured. Their heart rate and blood pressure may be taken. Changes to their breathing or changes in their body position may be measured. Participant data will be given a unique numerical identifier that can be used if the data is shared. Data will be stored on a server and in a database. Participants will have 1-2 visits. Each visit will last less than 4 hours. They may be contacted for a follow-up visit. Type: Observational Start Date: Jun 2024 |
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Clinical, Molecular and Imaging Biomarkers in Spinal and Bulbar Muscular Atrophy (SBMA)
National Institute of Neurological Disorders and Stroke (NINDS)
Spinal and Bulbar Muscular Atrophy
Kennedys Disease
Motor Neuron Disease
Background:
SBMA is an inherited chronic disease. It affects males in mid to late adulthood. It
causes slowly progressive weakness of muscles and hand tremors. Researchers want to learn
more about the effects of SBMA.
Objective:
To identify measurements that change over time in SBMA, including t1 expand
Background: SBMA is an inherited chronic disease. It affects males in mid to late adulthood. It causes slowly progressive weakness of muscles and hand tremors. Researchers want to learn more about the effects of SBMA. Objective: To identify measurements that change over time in SBMA, including tests of muscle strength and function, as well as measurements of muscle and fat size. Eligibility: Men over the age of 18 both with and without a history of SBMA. Design: Participants will have a medical history, physical exam, and blood and urine tests. They will have neuromuscular ultrasound. They will have a lumbar puncture to obtain spinal fluid. For this, a needle will be inserted into the spinal canal in the lower back. Participants will have muscle strength and function tests. These tests may include pushing, pulling, rising from a chair and sitting back down, and/or walking. During these tests, they may wear an accelerometer (activity tracker) on their wrist. Participants will get an activity tracker to wear on their wrist for 10 days at home every 3 months. Participants with SBMA will also have lower limb magnetic resonance imaging (MRI) and optional whole-body MRI. They will have lung function tests. They will have speech and swallow tests. They will complete questionnaires. They may have optional body scans to measure bone density and lean body mass. They may have optional muscle biopsies. For biopsies, a needle will be used to take a small piece of muscle from the leg. Participants with SBMA will have 5 study visits over 2 years (every 6 months). Participants without SBMA will have 1 study visit. Type: Observational Start Date: Oct 2021 |
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DDAVP for Pituitary Adenoma
National Institute of Neurological Disorders and Stroke (NINDS)
Cushing's Disease
Pituitary Adenoma
This study is designed as a single institution trial. The study utilizes safe and
clinically-validated tools for preoperative workup of patients with small pituitary
tumors. DDAVP stimulation and 18F-labeled fluoro-deoxyglucose (FDG) uptake for
PET-imaging will be used to detect MRI-negative pituit1 expand
This study is designed as a single institution trial. The study utilizes safe and clinically-validated tools for preoperative workup of patients with small pituitary tumors. DDAVP stimulation and 18F-labeled fluoro-deoxyglucose (FDG) uptake for PET-imaging will be used to detect MRI-negative pituitary adenomas in patients with Cushing s disease. Patients who have MRI-negative pituitary microadenomas will undergo FDG PET-imaging with DDAVP stimulation. Intravenous FDG will be given approximately four hours following DDAVP administration. Within 12 weeks after completion of the FDG high-resolution PET scan, patients will undergo surgical resection of the pituitary adenoma. Surgical and histological confirmation of adenoma location will be noted. All images will be read independently by neuroradiologists blinded to clinical and histopathological outcomes. The diagnostic and localization accuracy of PET-imaging will be assessed by comparing the PET findings with histopathology. Type: Interventional Start Date: Mar 2026 |
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Study of New Magnetic Resonance Imaging Methods of the Brain
National Institute of Neurological Disorders and Stroke (NINDS)
Healthy Volunteer
Magnetic Resonance Imaging
Healthy
fMRI
Brain Mapping
The purpose of this investigation is to develop improved magnetic resonance imaging (MRI)
techniques and hardware for studying brain function. MRI is a diagnostic tool that
provides information about brain chemistry and physiology. This study will evaluate new
MRI methods for monitoring blood flow1 expand
The purpose of this investigation is to develop improved magnetic resonance imaging (MRI) techniques and hardware for studying brain function. MRI is a diagnostic tool that provides information about brain chemistry and physiology. This study will evaluate new MRI methods for monitoring blood flow to regions of the brain in response to simple tasks. The MRI machine used in this study is more powerful than those in most hospitals, permitting a higher visual resolution. Normal healthy volunteers over 18 years old may be eligible for this study. Candidates will be screened with a medical history and questionnaire, and a neurological examination. Study participants will have a yearly MRI scan. For this procedure, the subject lies on a stretcher that is moved into a donut-shaped machine with a strong magnetic field. A lightweight circular or rectangular coil a device that improves the quality of the images may be placed on the head. The scan time varies from 20 minutes to 3 hours; most scans last between 45 and 90 minutes. During the scan, the subject may perform simple tasks, such as listening to tapes, tapping a finger, moving a hand, watching a screen, or smelling a fragrance. More complex tasks may require thinking about tones or pictures and responding to them by pressing buttons. Information from this study will be used to develop better imaging methods that will, in turn, permit a greater understanding of normal and abnormal brain behaviors. Type: Observational Start Date: Jul 2000 |
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Comprehensive Molecular and Clinical Evaluation of Pediatric and Adult MDS
National Cancer Institute (NCI)
Myelodysplastic Syndromes
Background:
Myelodysplastic syndromes (MDS) occur when the cells that make blood cells are abnormal.
There are limited treatment options for MDS. Researchers want to learn more through this
natural history study so they can develop better treatments.
Objective:
To study the natural course of MDS1 expand
Background: Myelodysplastic syndromes (MDS) occur when the cells that make blood cells are abnormal. There are limited treatment options for MDS. Researchers want to learn more through this natural history study so they can develop better treatments. Objective: To study the natural course of MDS and MDS/myeloproliferative neoplasms (MPN) and collect biological samples that can help researchers understand the disease. Eligibility: People with suspected or confirmed MDS or MDS/MPN. Healthy donors are also needed. They can be people who are scheduled to donate bone marrow at NIH for a relative, or they may be providing bone marrow in another study. Design: Participants will be screened with a medical history. Participants will have a physical exam. They will give blood and urine samples. They will discuss their symptoms, medications, and ability to perform their normal activities. They will complete surveys about how they are feeling. Participants will have a bone marrow biopsy. A needle will be inserted through a small cut. Bone marrow will be removed. A small piece of bone may be removed. Participants may have an optional skin biopsy. Participants may give optional saliva and stool samples. They may collect these samples at home and mail them to NIH. Participants may undergo optional apheresis. One or two needles or intravenous (IV) lines will be placed in their arm, neck, or groin veins. Blood will be removed. A machine will separate out the white cells. The rest of the blood will be returned to the participant. Participants will be contacted for follow-up once a year for up to 20 years. Healthy donors will have marrow collected for this study during their scheduled procedure with no follow-up. Type: Observational Start Date: Aug 2022 |
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Collection of Clinical Data and Specimens for Research in Hearing, Balance, Taste, Smell, Voice, Sp1
National Institute on Deafness and Other Communication Disorders (NIDCD)
Hearing Loss
Deafness
Background:
People with hearing, balance, and taste, smell, voice, speech, language, and other Ear,
Nose, and Throat (ENT) disorders may seek treatment at the National Institute on Deafness
and Other Communication Disorders (NIDCD). Some of these people may benefit from
enrolling in the NIDCD intr1 expand
Background: People with hearing, balance, and taste, smell, voice, speech, language, and other Ear, Nose, and Throat (ENT) disorders may seek treatment at the National Institute on Deafness and Other Communication Disorders (NIDCD). Some of these people may benefit from enrolling in the NIDCD intramural research program to receive their care. Enrolling will also allow investigators to collect participants clinical data and specimens for future research. Objective: This natural history study has 2 goals: (1) to collect data and specimens that may be used for research; and (2) to evaluate participants who may be candidates for other research studies. Eligibility: People aged 2 years or older with a hearing, balance, and communication disorder. Those at risk or who are suspected of having such a disorder are also eligible. Design: Participants will be screened. Their medical records will be reviewed. Participants will agree to have their medical data used for research. Specimens such as blood or other tissue samples may also be used for research. All data and specimens will be collected during their routine care visits. All tests done will be the normal care for each participant s condition. No tests will be done solely for research. Some of these tests may require blood or tissue samples. Some may use special tools to test hearing and balance. Some may test heart or lung function. These tests may also include different types of imaging scans. All tests will be explained. Participants may ask questions at any time. Participants may remain in this study for up to 2 years. If they need further care, they may sign a new consent. ... Type: Observational Start Date: Mar 2023 |
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Natural History Study of GATA2 Deficiency and Related Disorders
National Institute of Allergy and Infectious Diseases (NIAID)
GATA2 Deficiency
Background:
- GATA2 deficiency is a genetic disorder that can cause problems with a person s immune
system and other body systems. Some people who have this disorder develop few problems
from it. Others can have a wide range of health problems, from skin problems, to hearing
loss, to cancer. These1 expand
Background: - GATA2 deficiency is a genetic disorder that can cause problems with a person s immune system and other body systems. Some people who have this disorder develop few problems from it. Others can have a wide range of health problems, from skin problems, to hearing loss, to cancer. These problems can happen at any age. Researchers want to study GATA2 deficiency to better understand what types of health problems it can cause, and why it causes problems in some people but not others, and at different ages. Objectives: - To improve understanding of GATA2 deficiency so there can be better diagnostic tests and treatments in the future. Eligibility: - People 2 years of age or older who have a GATA2 gene mutation or certain health conditions that are commonly seen in people with this mutation and their blood relatives. Design: - Participants will be screened with a physical exam and medical history. Blood and urine samples will be collected to see whether participants have the GATA2 genetic mutation. Several other tests may be recommended, but participants can decline to take them. - Participants will be eligible to receive standard care for GATA2 deficiency through this protocol. They may be eligible for other clinical trials at the National Institutes of Health as well. - Participants will have regular study visits once a year to evaluate their GATA2 deficiency. Participants will take part in the study for at least 3 years and up to 15 years. At these follow-up visits, participants will fill out a questionnaire and take a physical exam and blood tests. Other tests may be performed as needed. Type: Observational Start Date: Aug 2013 |
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Personalized Environment and Genes Study
National Institute of Environmental Health Sciences (NIEHS)
Diabetes
Heart Disease
Asthma
Despite the overwhelming focus on genetic and genomic causes of human disease over the
past two decades, it has been estimated that genetics is currently known to explain only
20% and 40% of the etiology of common disease. Thus, it is becoming increasingly apparent
that human disease is a consequen1 expand
Despite the overwhelming focus on genetic and genomic causes of human disease over the past two decades, it has been estimated that genetics is currently known to explain only 20% and 40% of the etiology of common disease. Thus, it is becoming increasingly apparent that human disease is a consequence of both genetic susceptibility and environmental exposures. Importantly, while individuals cannot change their genetic composition, we do have the ability both personally and as a society, to influence our environment, promoting health and decreasing the risk of disease. The Personalized Environment and Genes Study (PEGS) aims to determine how the environment and gene-environment interactions can inform our understanding of human health and disease. As science has evolved, so too has the science of this project. This evolution was reflected in a change in the title of this project from the Environmental Polymorphisms Registry (EPR) to the Personalized Environment and Genes Study (PEGS) to more accurately reflect the science that can be conducted. PEGS is a unique resource because of the depth of environmental phenotyping which includes extensive information from exposome surveys, as well as whole genome sequencing on a significant number of participants in the cohort. While it is small relative to genomic cohorts, none of these have the extensive environmental data that is present in PEGS. In addition, other cohorts with deep environmental data lack the depth of genomic data that is present in PEGS. Importantly, PEGS has already provided important analytic advances that are of great interest to and can be confirmed in larger cohorts such as All of Us. The Personalized Environment and Genes Study (PEGS) aims to provide a resource for environmental health translational research by examining gene-environment interactions in health and disease. PEGS is an extension of two previous efforts where it began as a pilot study, the Environmental Polymorphisms Study (EPS; IRB# 02E9004) and was approved subsequently as a full protocol titled the Environmental Polymorphisms Registry (EPR) (IRB #04-E-N0053 and transitioned to its current ID# 04-E-0053). The EPR was envisioned as a phenotype-by-genotype registry of participants who had donated DNA samples, and who had agreed to be contacted for follow-up clinical translational studies based on their DNA genotypes. At the time, the only information available was a participant s age, sex, race, and ethnicity. Further phenotyping of a participant and/or any biospecimens obtained were investigated during a follow-up translational clinical study on participants recruited based on their genotype (hence phenotype-by-genotype) and the PEGS was the first recruit-by- genotype study at the NIH. Following a period focused on recruiting approximately 15,000 participants to enable genotyping of rare (approximately 1% minor allele frequency) single nucleotide polymorphisms (SNPs), the PEGS Consortium Project was undertaken in 2010- 2011 to examine, using the DNA of nearly 4,000 participants, approximately 700 SNPs in approximately 80 environmental response genes that work in concert with environmental exposures to elicit a phenotype. Several clinical follow-up studies, genotype-phenotype association studies, and publications have resulted from the PEGS Consortium Project. To expand phenotype information available to researchers, the Health and Exposure Questionnaire was administered between 2013-2014. In 2017, a more detailed Exposome Questionnaire which includes questions relating to the external and internal exposome was administered. This was an important resource through which to integrate exposures with genotype-phenotype association studies. Whole genome sequencing has now been performed on approximately 4700 participants who were reconsented for this purpose, as indicated above. Questionnaire data was fully adjudicated and combined in a robust and searchable database. With the increased power of the data available, the project was renamed as the Personalized Environment and Genes Study (PEGS) and rolled out in Sept. 2021. Type: Observational Start Date: May 2010 |
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Genetic and Physical Study of Childhood Nerve and Muscle Disorders
National Institute of Neurological Disorders and Stroke (NINDS)
Muscular Dystrophies
Muscle Myopathies
Hereditary Spastic Paraplegias
Inherited Neuropathies
Inherited Neuromuscular Conditions
Background:
- Some nerve and muscle disorders that start early in life (before age 25), like some
forms of muscular dystrophy, can run in families. However, the genetic causes of these
disorders are not known. Also, doctors do not fully understand how symptoms of these
disorders change over time.1 expand
Background: - Some nerve and muscle disorders that start early in life (before age 25), like some forms of muscular dystrophy, can run in families. However, the genetic causes of these disorders are not known. Also, doctors do not fully understand how symptoms of these disorders change over time. Researchers want to learn more about genetic nerve and muscle disorders that start in childhood by studying affected people and their family members, as well as healthy volunteers. Objectives: - To better understand nerve and muscle disorders that start early in life and run in families. Eligibility: - Individuals at least 4 weeks old with childhood-onset muscular and nerve disorders, including those who have a later onset of a disorder that typically has childhood onset. - Affected and unaffected family members of the individuals with muscular and nerve disorders. - Healthy volunteers at least 4 weeks old with no nerve or muscle disorders. Design: - Participants will be screened with a physical exam and medical history. Genetic information will be collected from blood, saliva, cheek swab, or skin samples. Urine samples may also be collected. - Healthy volunteers and unaffected family members will have imaging studies of the muscles. These studies will include magnetic resonance imaging (MRI) and ultrasound scans. Results will be compared with those from the affected participants. - All participants with nerve and muscle disorders will have multiple tests, including the following: - Imaging studies of the muscles, including ultrasound and MRI scans. - Imaging studies of the bones, such as x-rays and DEXA scans. - Heart and lung function tests. - Eye exams. - Nerve and muscle electrical activity tests and biopsies. - Video and photo image collection of affected muscles. - Speech, language, and swallowing evaluation. - Lumbar puncture to collect spinal fluid for study. - Tests of movement, attention, thinking, and coordination. - Participants with nerve and muscle disorders will return to the Clinical Center every year. They will repeat the tests and studies at these visits. Type: Observational Start Date: Mar 2012 |
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Flow Detection in Open and Closed Shunt Valve Periods
Rhaeos, Inc.
Hydrocephalus
This study is evaluating a new, noninvasive device designed to detect whether
cerebrospinal fluid (CSF) is flowing through a surgically implanted shunt. CSF shunts are
commonly used to treat hydrocephalus, but it can be difficult to tell whether a shunt is
working properly without invasive testing1 expand
This study is evaluating a new, noninvasive device designed to detect whether cerebrospinal fluid (CSF) is flowing through a surgically implanted shunt. CSF shunts are commonly used to treat hydrocephalus, but it can be difficult to tell whether a shunt is working properly without invasive testing or imaging that does not directly measure flow. The study device is a small, wireless sensor placed on the skin over the shunt tubing, typically near the collarbone. It uses gentle, controlled warmth to measure temperature changes that indicate whether fluid is flowing inside the shunt. The device does not break the skin and does not change a participant's medical care. This study will enroll children and adults who already have a CSF shunt and who do not have new or worsening symptoms of shunt malfunction. All participants will have a measurement taken while their shunt valve is at its usual prescribed setting. Some participants with programmable shunt valves will also have a second measurement taken after their valve is temporarily adjusted to a setting intended to stop or greatly reduce flow ("virtual off"). After this measurement, the valve will be returned to its prescribed setting. The study device results will not be shown to participants or their medical providers and will not be used to make treatment decisions. The goal of the study is to determine how well the device can distinguish between shunts that are allowing flow and those that are not. Participants will be monitored for a short period after device use and, if applicable, after any valve adjustment. The main risks of participation are mild skin irritation from the adhesive or temporary symptoms related to valve adjustment. Participants are not expected to receive a direct medical benefit, but the information gained may help improve future diagnosis of shunt function. Type: Interventional Start Date: Jan 2026 |
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Behavioral Approach for Latinas Addressing Nutrition, Cravings, and Eating Patterns to Prevent Type1
University of California, San Diego
Prediabetes
Obesity (Body Mass Index >30 kg/m2)
Adapt the Regulation of Cues (ROC) treatment program for Latinas to see if it can treat
prediabetes and prevent developing of Type 2 Diabetes and reduce weight. expand
Adapt the Regulation of Cues (ROC) treatment program for Latinas to see if it can treat prediabetes and prevent developing of Type 2 Diabetes and reduce weight. Type: Interventional Start Date: Mar 2026 |
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Effects of Whole-body Electrical Muscle Stimulation Exercise on Adults With Neuromuscular Disease
University of Missouri-Columbia
Neuromuscular Diseases (NMD)
Amyotrophic Lateral Sclerosis
Myasthenia Gravis
Lambert-eaton Myasthenic Syndrome
Primary Lateral Sclerosis
This single-arm pilot study evaluates the effects of whole-body electrical muscle
stimulation (WB-EMS) exercise on neuromuscular and physical function in adults with
neuromuscular disease (NMD). Due to motor unit impairments, NMD patients often cannot
tolerate traditional exercise. WB-EMS bypasses1 expand
This single-arm pilot study evaluates the effects of whole-body electrical muscle stimulation (WB-EMS) exercise on neuromuscular and physical function in adults with neuromuscular disease (NMD). Due to motor unit impairments, NMD patients often cannot tolerate traditional exercise. WB-EMS bypasses voluntary activation limits by directly stimulating muscle contractions. Up to 50 adults with conditions like ALS, SMA, and MG will undergo 20-minute supervised WB-EMS sessions (1-2 times weekly for 4-8 weeks) using the Katalyst system. Outcomes include neural excitability (TMS), motor unit behavior (EMG, NCS), functional tests (walk, balance, strength), and patient-reported fatigue, pain, and quality of life. Strict safety monitoring and exclusion criteria are in place. This study will provide preliminary data on WB-EMS as a potential exercise modality for NMD. Type: Interventional Start Date: Mar 2026 |
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A Study of Gefitinib, Trametinib, Disulfiram, and Sunitinib in Addition to Standard Chemotherapy in1
Memorial Sloan Kettering Cancer Center
Osteosarcoma
Metastasis
The researchers are doing this study to find out whether adding gefitinib, trametinib,
disulfiram, and sunitinib to standard chemotherapy is a more effective treatment approach
for people with osteosarcoma than standard chemotherapy on its own. The researchers will
also look at the safety of adding1 expand
The researchers are doing this study to find out whether adding gefitinib, trametinib, disulfiram, and sunitinib to standard chemotherapy is a more effective treatment approach for people with osteosarcoma than standard chemotherapy on its own. The researchers will also look at the safety of adding these drugs to standard chemotherapy. The researchers will also use the additional research biopsies from Cohort 1 participants to learn more about how osteosarcoma survives during chemotherapy. Type: Interventional Start Date: Mar 2026 |
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Continuous Glucose Monitoring (CGM) in Prediabetes With Health Education Videos: Cohort 3
David S Black, PhD
Prediabetes
The objective of this project is to develop a behavioral intervention that combines
wearable continuous glucose monitoring (CGM) with smartphone feedback and educational
video clips generated by artificial intelligence (AI) software to improve glycemic
control among individuals with pre-diabetes. T1 expand
The objective of this project is to develop a behavioral intervention that combines wearable continuous glucose monitoring (CGM) with smartphone feedback and educational video clips generated by artificial intelligence (AI) software to improve glycemic control among individuals with pre-diabetes. The goal is to prevent transition to type 2 diabetes (T2D). Type: Interventional Start Date: Feb 2026 |
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Heart Institute Biobank & Registry for Adult Congenital Heart Disease and Related Disorders
Children's Hospital Medical Center, Cincinnati
Adult Congenital Heart Disease
Pulmonary Hypertension
Connective Tissue Disease
Other Cardiovascular Conditions
A repository of biospecimens and detailed phenotypic information collected longitudinally
from adults with congenital heart disease and related conditions, with an aim to
facilitate future research on biologic mechanisms of underlying disease, compensation and
deterioration; biologic correlates of1 expand
A repository of biospecimens and detailed phenotypic information collected longitudinally from adults with congenital heart disease and related conditions, with an aim to facilitate future research on biologic mechanisms of underlying disease, compensation and deterioration; biologic correlates of patient experience and functional status; associations between clinical characteristics and various biomarkers; and predictors of clinical outcomes. Type: Observational [Patient Registry] Start Date: Jul 2021 |
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Studying the Relationship of Patient Positioning and Intravesical Bacillus Calmette Guerin Dwell Ti1
Ohio State University Comprehensive Cancer Center
Non-Muscle Invasive Bladder Carcinoma
This phase IV trial studies whether there is a relationship between how a patient is
positioned while receiving bacillus Calmette Guerin (BCG) within the bladder
(intravesical) and how long BCG stays in the bladder (dwell time) to improve the
treatment of non-muscle invasive bladder cancer. For the1 expand
This phase IV trial studies whether there is a relationship between how a patient is positioned while receiving bacillus Calmette Guerin (BCG) within the bladder (intravesical) and how long BCG stays in the bladder (dwell time) to improve the treatment of non-muscle invasive bladder cancer. For the past 40 years, intravesical BCG has been used for the treatment of non-muscle invasive bladder cancer. An important factor for BCG treatment is the dwell time, which is the period of time a patient can hold the BCG medication in the bladder after it has been given. Normally, patients are instructed during intravesical BCG treatment to avoid emptying the bladder for 2 hours after the BCG is given. However, this may be difficult for some patients who may have limited bladder capacity, restricted movement, or severe urinary symptoms. There have been studies outlining the relationship with increased dwell time and how well the treatment works, but studies on the potential impact of patient positioning or activity on the patient's ability to retain the drug are limited. Researchers hope by studying whether there is a relationship between patient positioning during intravesical BCG treatment and dwell time, they may be able to improve how BCG treatment for non-muscle invasive bladder cancer is given, especially for patients with limited bladder capacity, restricted movement, or severe urinary symptoms. Type: Interventional Start Date: Feb 2026 |
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Copper Supplementation in Cirrhosis
University of Washington
Cirrhosis
Chronic Liver Disease
Fibrosis
Infection
End stage liver disease or cirrhosis is a major cause of mortality in the United States
and the world. Other than targeting the underlying cause, such as alcohol cessation and
antiviral therapy, very few medical treatments can change the natural history of
cirrhosis. Malnutrition is one of the few1 expand
End stage liver disease or cirrhosis is a major cause of mortality in the United States and the world. Other than targeting the underlying cause, such as alcohol cessation and antiviral therapy, very few medical treatments can change the natural history of cirrhosis. Malnutrition is one of the few potentially modifiable factors that have been associated with cirrhosis severity and poor prognosis. The transition metal copper (Cu) is an essential trace metal that must be acquired from diet. Its metabolism is primarily regulated by the liver in its role as a master regulator of nutrients. In 2019, the investigators reported that Cu deficiency defined by below normal serum or liver concentrations occurred in a wide range of liver disorders and was associated with a severe disease phenotype. Improvement in liver function was observed in 2 of the 3 patients who received Cu supplementation. In 2023, the investigators conducted a longitudinal cohort study utilizing clinical, serum and liver explant tissue data from 183 cirrhosis patients. The investigators showed that Cu deficiency was associated with 2-fold higher infection rate and a more than 3-fold increase in the risk of death compared to patients with normal Cu status. These preliminary findings and the well-established importance of Cu in human health prompted the investigators to design the current pilot randomized, placebo-controlled, crossover trial to determine the effect of Cu supplementation on Cu dependent biochemical changes, patient safety and patient reported outcomes in cirrhosis. Type: Interventional Start Date: Mar 2026 |
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Centered Surgery - Preoperative Counseling and Patient Satisfaction
The Cleveland Clinic
Pelvic Organ Prolapse
This study is a prospective cohort study which aims to assess patient satisfaction and
preparedness for surgery through two methods of preoperative counseling: standard
individual phone calls versus virtual group sessions called Shared Medical Appointments
(SMAs). The study will focus on patients u1 expand
This study is a prospective cohort study which aims to assess patient satisfaction and preparedness for surgery through two methods of preoperative counseling: standard individual phone calls versus virtual group sessions called Shared Medical Appointments (SMAs). The study will focus on patients undergoing urogynecology prolapse surgeries at Cleveland Clinic. Researchers hypothesize that virtual group counseling will improve patient satisfaction and preparedness compared to individual phone calls. Additionally, the study will evaluate healthcare resource utilization as a secondary outcome. Participants will complete surveys before and after surgery to measure satisfaction and preparedness using validated tools. The study will enroll patients aged 18 and older who can provide informed consent and are scheduled for specific prolapse surgeries. Findings may help improve preoperative counseling practices and enhance patient-centered care. Type: Observational Start Date: Mar 2026 |
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Prospective Registry of Histotripsy for Soft Tissue Tumors
University of California, San Francisco
Soft Tissue Neoplasm
Soft Tissue Cancer
Soft Tissue Lesion
Histotripsy is a treatment that uses focused ultrasound waves to break down tissue
without surgery. The ultrasound waves meet at a specific spot and turn the tissue into
liquid. This study is a prospective observational registry of participants receiving
histotripsy. The goal of this study is to ga1 expand
Histotripsy is a treatment that uses focused ultrasound waves to break down tissue without surgery. The ultrasound waves meet at a specific spot and turn the tissue into liquid. This study is a prospective observational registry of participants receiving histotripsy. The goal of this study is to gather information about the use of histotripsy to confirm it is safe and effective medical procedure. Type: Observational [Patient Registry] Start Date: Jan 2026 |
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Synchronization of Theta to Influence Memory
Florida International University
Cognitive Control
Memory
This study aims to clarify relations between brain oscillations and two cognitive
functions: cognitive control and memory. expand
This study aims to clarify relations between brain oscillations and two cognitive functions: cognitive control and memory. Type: Interventional Start Date: Mar 2026 |
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Postnatal Exercise to Activate Baby's Brown Fat
Joslin Diabetes Center
Childhood Obesity Prevention
Childhood Obesity
Physical Activity
Lactation
Breastfeeding
The purpose of this study is to learn how exercise and physical activity during pregnancy
and after pregnancy may affect the composition of breastmilk. Certain changes in breast
milk after exercise may have an impact on how infants use energy. Understanding this
process may improve public health re1 expand
The purpose of this study is to learn how exercise and physical activity during pregnancy and after pregnancy may affect the composition of breastmilk. Certain changes in breast milk after exercise may have an impact on how infants use energy. Understanding this process may improve public health recommendations for exercise during and after pregnancy. This study can help investigators learn more about how maternal exercise patterns may affect body growth and obesity risk in infants who are breastfed. This research may help identify how different factors can influence healthy weight and early development in infants. Type: Interventional Start Date: Dec 2025 |
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A Study of ELA026 in Participants With Relapsed/Refractory (R/R) T/NK Cell Malignancies (TCMs)
Electra Therapeutics Inc.
T Cell Malignancies
This is a Phase 1, two-part, multicenter study to evaluate ELA026 in participants ≥18
years old with relapsed/refractory TCM following any line of prior therapy who are
eligible for investigational treatments. expand
This is a Phase 1, two-part, multicenter study to evaluate ELA026 in participants ≥18 years old with relapsed/refractory TCM following any line of prior therapy who are eligible for investigational treatments. Type: Interventional Start Date: Feb 2026 |