
Search Clinical Trials
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Hypofractionation Trial of Re-irradiation in Good Prognosis Recurrent Glioblastoma
National Cancer Institute (NCI)
Astrocytoma
Glioma
Recurrent Glioblastoma
Background:
Glioblastoma (GBM) is a cancer of the brain. Current survival rates for people with GBM
are poor; survival ranges from 5.2 months to 39 months. Most tumors come back within
months or years after treatment, and when they do, they are worse: Overall survival drops
to less than 10 months.1 expand
Background: Glioblastoma (GBM) is a cancer of the brain. Current survival rates for people with GBM are poor; survival ranges from 5.2 months to 39 months. Most tumors come back within months or years after treatment, and when they do, they are worse: Overall survival drops to less than 10 months. No standard treatment exists for people whose GBM has returned after radiation therapy. Objective: To find a safe schedule for using radiation to treat GBM tumors that returned after initial radiation treatment. Eligibility: People aged 18 years and older with grade 4 GBM that returned after initial radiation treatment. Design: Participants will be screened. They will have a physical exam with blood tests. A sample of tumor tissue may be collected. Participants will undergo re-irradiation planning: They will wear a plastic mask over their head during imaging scans. These scans will pinpoint the exact location of the tumor. This spot will be the target of the radiation treatments. Participants will undergo radiation treatment 4 times per week. Some people will have this treatment for 3 weeks, some for 2 weeks, and some for 1 week. Blood tests and other exams will be repeated at each visit. Participants will complete questionnaires about their physical and mental health. They will answer these questions before starting radiation treatment; once a week during treatment; and at intervals for up to 3 years after treatment ends. Participants will have follow-up visits 1 month after treatment and then every 2 months for 6 months. Follow-up clinic visits will continue up to 3 years. Follow-ups by phone or email will continue an additional 2 years. Type: Interventional Start Date: Oct 2024 |
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Pembrolizumab, Lenvatinib and IL-15 Superagonist N-803 in Combination With HER2 Targeting Autologou1
National Cancer Institute (NCI)
Endometrial Cancer
Cancer of Endometrium
Carcinoma of Endometrium
Endometrial Carcinoma
Background:
Endometrial cancer (EC) of the uterus is becoming more common in the US. Sometimes EC
often has increased levels of a protein called HER2. Cancers with HER2 tend to be more
aggressive and have poorer outcomes.
Objective:
To test 2 study drugs-a vaccine that targets HER2 (AdHER2DC) pl1 expand
Background: Endometrial cancer (EC) of the uterus is becoming more common in the US. Sometimes EC often has increased levels of a protein called HER2. Cancers with HER2 tend to be more aggressive and have poorer outcomes. Objective: To test 2 study drugs-a vaccine that targets HER2 (AdHER2DC) plus a drug that supercharges immune cells that kill tumor cells (N-803)-combined with 2 FDA-approved cancer treatment drugs in people with EC. Eligibility: Adults aged 18 and older with HER2-positive EC that returned or got worse after treatment. Design: AdHER2DC vaccine is made from each participant s own blood. Participants will undergo apheresis: Blood is removed from the body through a tube attached to a needle. The blood passes through a machine that separates out the target cells. The remaining blood is returned to the body through a second needle. A special catheter may be needed. The first treatment cycle is 28 days; each cycle after that will be 21 days. All participants will get the 2 approved drugs and the vaccine. One drug is a tablet taken by mouth once a day, every day. The other drug is given through a tube attached to a needle inserted into a vein. The vaccine is injected under the skin. Participants will receive the vaccine on day 1 of cycles 1, 2, and 3. Additional doses up to 3 doses will be give if possible. Some participants will receive N-803. This drug is injected under the skin of the abdomen on day 1 of each cycle. Treatment may last up to 1 year. Follow-up visits will continue up to 2 more years. Type: Interventional Start Date: May 2024 |
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Study of Aerosolized Antibiotics and Pembrolizumab in Advanced Non-small Cell Lung Cancer
National Cancer Institute (NCI)
Advanced Non Small Cell Lung Cancer
Background:
Non-small cell lung cancer (NSCLC) can be hard to treat and is often fatal. People with
NSCLC commonly have changes in the bacteria that populate their lungs. These bacterial
changes may aid tumor growth. Researchers want to find out if treating the bacteria, too,
can help cancer treat1 expand
Background: Non-small cell lung cancer (NSCLC) can be hard to treat and is often fatal. People with NSCLC commonly have changes in the bacteria that populate their lungs. These bacterial changes may aid tumor growth. Researchers want to find out if treating the bacteria, too, can help cancer treatment work better. Objective: To test 2 inhaled antibiotics (aztreonam and vancomycin), combined with a standard cancer treatment, in people with NSCLC. Eligibility: People aged 18 years and older with NSCLC that has returned or progressed after treatment and cannot be treated with surgery. Design: Participants will be screened. They will have a physical exam with blood tests. They may blow into a machine to test how well their lungs work. They will have imaging scans. They may need to have a small piece of tissue cut from their tumor (biopsy). Participants will be treated in six 21-day cycles. They will visit the clinic to receive a drug for cancer treatment on the first day of each cycle. This drug will be administered through a tube attached to a needle inserted into a vein in the arm. The 2 antibiotic drugs will be in the form of a fine mist that can be inhaled. Participants use a device to take these drugs at home. They will inhale aztreonam up to 3 times a day and vancomycin 1 or 2 times a day. They will take these drugs during only 3 of the treatment cycles. Biopsies and other tests will be repeated halfway through and after the study treatment. Follow-up visits will continue for 1 year after study treatment. Type: Interventional Start Date: Apr 2024 |
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Data Collection Study of Pediatric and Adolescent Gynecology Conditions
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Disorders of Sex Development (DSD)
Pediatric and Adolescent Cancers of the Genital Tract
Reproductive Endocrine Conditions in Puberty
Structural Gynecologic Conditions Including Vulvar and Vaginal Conditions
Background:
Gynecologic conditions are those that are related to the reproductive system. They can be
reproductive gland disorders or reproductive system tumors. They can also be inborn
anomalies of the reproductive tract. Researchers want to gather data over time from a
large group of young peopl1 expand
Background: Gynecologic conditions are those that are related to the reproductive system. They can be reproductive gland disorders or reproductive system tumors. They can also be inborn anomalies of the reproductive tract. Researchers want to gather data over time from a large group of young people with these conditions. Objective: To create a database about child and teenage gynecologic conditions. Eligibility: Participants of any age with known or suspected pediatric and adolescent gynecologic conditions, and their adult family members Design: Participants will be screened with a review of their medical records. Participants may have a medical history and physical exam. Participants will have blood drawn using a needle. The blood will be used for genetic tests. Participants will have saliva collected. They will spit into a small plastic container. Or their spit will be absorbed from their mouth using a small sponge. The saliva will be used for genetic tests. Participants may have samples collected from their vagina. A small cotton swab will be used to gather the samples. This procedure is optional. If participants have a surgery related to their condition, a small tissue sample will be taken. It will be stored for future research. Participants may complete optional surveys. These surveys ask about their physical and emotional health. They can choose not to answer any of the questions. Researchers will collect medical data from participants standard tests. Such tests may include blood and urine tests, X-rays, nuclear medicine scans, and other tests. Data will also be collected from standard treatments they may receive. Type: Observational Start Date: Apr 2021 |
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Central Nervous System Uptake of Anti-CD8+ T Cell Minibodies in Multiple Sclerosis and Progressive1
National Institute of Neurological Disorders and Stroke (NINDS)
Multiple Sclerosis
Progressive Multifocal Leukoencephalopathy
Background:
Multiple sclerosis (MS) and progressive multifocal leukoencephalopathy (PML) are
disorders that affect the central nervous system (CNS). The CNS includes the brain,
spinal cord, and optic nerves. Both diseases can cause muscle weakness and impair vision,
speech, and coordination. Resea1 expand
Background: Multiple sclerosis (MS) and progressive multifocal leukoencephalopathy (PML) are disorders that affect the central nervous system (CNS). The CNS includes the brain, spinal cord, and optic nerves. Both diseases can cause muscle weakness and impair vision, speech, and coordination. Researchers are working to better understand how MS and PML affect the CNS. Objective: To test whether an experimental radioactive tracer (minibody) can help positron emission tomography (PET) scans detect certain immune cells in the CNS of people with MS and PML. Eligibility: People aged 18 years and older with MS, other neuroinflammatory diseases with BBB leakage, or PML. Design: Participants will come to the clinic for at least 3 visits over 4 to 6 weeks. Participants will undergo testing. They will have a physical and neurological exam. They will have blood tests and tests of their heart function. They will have a magnetic resonance imaging (MRI) scan of the brain. They may have a spinal tap: Their lower back will be numbed, and a needle will be inserted between the bones of the spine to withdraw fluid from around the spinal cord. Minibody is given through a tube with a needle placed in a vein in the arm. This takes 5 to 10 minutes. Participants will have heart function tests before and after receiving the minibody. Participants may have a PET scan on the day of the Minibody and will return the next day for another PET scan. They will lie on a table that moves through a doughnut-shaped machine. This scan will take about 1 hour. Participants with PML may opt to repeat the minibody infusion and the PET scan within 6 months. Type: Interventional Start Date: Oct 2023 |
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PT-112 in Subjects With Thymoma and Thymic Carcinoma
National Cancer Institute (NCI)
Thymic Epithelial Tumor
Recurrent Thymoma
Thymic Cancer
Background:
There are no approved drugs to treat recurrent thymoma and thymic carcinoma. New
therapies are needed for people with these cancers. Researchers want to see if the drug
PT-112 can help. PT-112 kills cancer cells. It also helps the body s immune system fight
cancer.
Objective:
To see1 expand
Background: There are no approved drugs to treat recurrent thymoma and thymic carcinoma. New therapies are needed for people with these cancers. Researchers want to see if the drug PT-112 can help. PT-112 kills cancer cells. It also helps the body s immune system fight cancer. Objective: To see if the study drug PT-112 can cause tumors to shrink. Eligibility: People ages 18 and older who have thymoma or thymic cancer and whose disease returned or progressed after treatment with at least one platinum-containing chemotherapy, or who have refused standard treatment. Design: Participants will be screened with: Review of medical history and medications Physical exam Blood and urine tests CT or MRI scans of parts of the body, including the brain Participants will get PT-112 in 28-day cycles, on days 1 and 15 of of the first cycle and on day 1 of each cycle after that. They will get the drug by infusion through a catheter. The catheter is a small plastic tube put into a vein. On days they receive the drug, participants will have physical exams and blood and urine tests. They will have an ECG to test heart function on day 1 of each cycle. Participants will have scans every 8 weeks. Participants may choose to have tumor biopsies on day 1 of cycles 1 and 3. Biopsies may be guided by an ultrasound or CT scan. Participants will continue treatment as long as they can handle the side effects and their disease does not get worse, for up to 8 years. Participants will have follow-up visits 2 weeks and 4 weeks after they stop therapy. Then the study team will check on participants every 3 months until 8 years after the participant joined the study. Type: Interventional Start Date: Apr 2022 |
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Phase I/II Study to Reduce Post-transplantation Cyclophosphamide Dosing for Older or Unfit Patients1
National Cancer Institute (NCI)
Hematologic Neoplasms
Background:
Certain blood cancers can be treated with blood or bone marrow transplants. Sometimes the
donor cells attack the recipient's body, called graft-versus-host disease (GVHD). The
chemotherapy drug cyclophosphamide helps reduce the risk and severity of GVHD.
Researchers want to learn if us1 expand
Background: Certain blood cancers can be treated with blood or bone marrow transplants. Sometimes the donor cells attack the recipient's body, called graft-versus-host disease (GVHD). The chemotherapy drug cyclophosphamide helps reduce the risk and severity of GVHD. Researchers want to learn if using a lower dose of cyclophosphamide may reduce the drug's side effects while maintaining its effectiveness. Such an approach is being used in an ongoing clinical study at the NIH with promising results, but this approach has not been tested for transplants using lower doses of chemotherapy/radiation prior to the transplant. Objective: To learn if using a lower dose of cyclophosphamide will help people have a successful transplant and have fewer problems and side effects. Eligibility: Adults ages 18-85 who have a blood cancer that did not respond well to standard treatments or is at high risk for relapse without transplant, and their donors. Design: Participants may be screened with the following: Medical history Physical exam Blood and urine tests Heart and lung tests Body imaging scans (they may get a contrast agent) Spinal tap Bone marrow biopsy Participants will be hospitalized for 4-6 weeks. They will have a central venous catheter placed in a chest or neck vein. It will be used to give medicines, transfusions, and the donor cells, and to take blood. In the week before transplant, they will get 2 chemotherapy drugs and radiation. After the transplant, they will get the study drug for 2 days. They will take other drugs for up to 2 months. Participants must stay near NIH for 3 months after discharge for weekly study visits. Then they will have visits every 3-12 months until 5 years after transplant. Participants and donors will give blood, bone marrow, saliva, cheek swab, urine, and stool samples for research. Type: Interventional Start Date: Sep 2021 |
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Collection of Blood and Urine Samples in Patients Receiving Radiation Therapy for Glioblastoma Mult1
National Cancer Institute (NCI)
Glioblastoma Multiforme
This study will collect blood and urine samples from patients undergoing radiation
therapy for glioblastoma multiforme (a type of brain tumor) to investigate the effects of
this treatment on blood cells and certain proteins. The information from this study may
help scientists develop new tests to m1 expand
This study will collect blood and urine samples from patients undergoing radiation therapy for glioblastoma multiforme (a type of brain tumor) to investigate the effects of this treatment on blood cells and certain proteins. The information from this study may help scientists develop new tests to measure radiation exposure and find new ways to treat cancer with radiation, and help determine which kinds of patients or tumors respond better to radiation therapy. Two proteins of particular interest in this study and which may be involved in the recurrence of cancer are VEGF (vascular endothelial growth factor) and MMPs (matrix metalloproteinases). Patients 18 years of age and older with glioblastoma multiforme who are receiving or will receive radiation therapy as part of their medical treatment may be eligible for this study. Candidates are screened with a history and physical examination, blood tests, and magnetic resonance imaging (MRI) of the brain. Participants will have blood and urine samples collected before, during and after completion of their radiation treatment. Urine samples are collected in a cup and about 2 tablespoons of blood are withdrawn through a needle in a vein. Additional samples may be requested at different times during treatment and in the 3-year follow-up period. Type: Observational Start Date: Jun 2004 |
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Evaluation of Late Effects and Natural History of Disease in Patients Treated With Radiotherapy
National Cancer Institute (NCI)
Cancer
BACKGROUND
- This protocol acknowledges that it is in the interest of the NIH and ROB, as well as
our participants, to continue to follow those who have been treated with
radiotherapy at ROB and are not otherwise eligible for current active research
protocols.
- It also provi1 expand
BACKGROUND - This protocol acknowledges that it is in the interest of the NIH and ROB, as well as our participants, to continue to follow those who have been treated with radiotherapy at ROB and are not otherwise eligible for current active research protocols. - It also provides a mechanism for the correlation and interpretation of disparate data for research into the long term side effects and outcomes for a variety of disease entities and treatments, such as combined modality treatment, MoAb, PDT, radiation modifiers, intraoperative radiotherapy, etc. OBJECTIVE -The primary objective of this protocol is to assess the late effects of treatment and the natural history of disease through collection of data from any standard procedures performed as part of follow up care on participants previously treated with radiotherapy. ELIGIBILITY -Participants who received radiation therapy. DESIGN - This is a natural history protocol in which long-term follow up data will be collected from participants who received radiation therapy. - It will be made clear to participants in the consent form, that data collected during their follow-up may be used anonymously for publications concerning the natural history of disease processes and long-term effects of treatment. Type: Observational Start Date: Feb 2000 |
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Immune System Related Kidney Disease
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Kidney Disease
Nephrotic Syndrome
Kidney diseases related to the immune system include, nephrotic syndrome,
glomerulonephritis, membranous nephropathy, lupus nephritis, and nephritis associated
with connective tissue disorders.
This study will allow researchers to admit and follow patients suffering from autoimmune
diseases of the1 expand
Kidney diseases related to the immune system include, nephrotic syndrome, glomerulonephritis, membranous nephropathy, lupus nephritis, and nephritis associated with connective tissue disorders. This study will allow researchers to admit and follow patients suffering from autoimmune diseases of the kidney. It will attempt to provide information about the causes and specific abnormalities associated with autoimmune kidney disease. Patients with kidney disease as a result of their immune system, and patients with diseases of the immune system who may later develop kidney disease, will be potential subjects for this study. Patients will undergo a history and physical examination, and standard laboratory test to more closely understand the causes, signs, symptoms, and responses to medication of these diseases. Based on these evaluations the patients may qualify as candidates for other experimental studies. At any time these patients may be asked to submit blood or urine samples for further research. Type: Observational Start Date: Jun 1992 |
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Metagenomics Next-generation Sequencing Approach to Detect Microbial DNA/RNA Overtime in Individual1
National Institutes of Health Clinical Center (CC)
Hematopoietic Stem Cell Transplantation
Infections are a major cause of morbidity and mortality in patients undergoing
hematopoietic stem cell transplant (HSCT). The purpose of this study is to evaluate if
metagenomic next-generation sequencing (mNGS) can detect microbial signatures in people
undergoing HSCT, and if microbial identificat1 expand
Infections are a major cause of morbidity and mortality in patients undergoing hematopoietic stem cell transplant (HSCT). The purpose of this study is to evaluate if metagenomic next-generation sequencing (mNGS) can detect microbial signatures in people undergoing HSCT, and if microbial identification can be correlated with clinical features of infection (e.g., fever). Participants undergoing HSCT as part of other studies at the NIH Clinical Center (CC) will provide blood before the transplant and through 6 months after. Total nucleic acid will be extracted from plasma and subjected to mNGS. The primary objective of this study is to investigate if by using plasma and an mNGS approach, we can detect bacterial, fungal, protozoan, or viral DNA/RNA over time, in immunocompromised patients undergoing transplantation. Secondary objectives are to: (1) To correlate microbial identification with episodes of fever or clinical suspicion of infection; and to (2) correlate change in microbial signatures in patients with suspected immune reconstitution inflammatory syndrome. The study is conducted at the NIH Clinical Center. Participants, aged 3 years and older, on other research studies at the NIH CC who are undergoing HSCT are invited to take part of this study. Expected participation is up to six months. Type: Observational Start Date: Apr 2025 |
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Natural History Study of Parathyroid Disorders
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Parathyroid Cancer
Primary Hyperparathyroidism
Pseudohypoparathyroidism
Inheritable Bone Diseases
Multiple Endocrine Neoplasia, Type 1
Background:
Parathyroid disorders are very common in the general population and include disorders of
parathyroid excess, deficiency, or defects in parathyroid hormone (PTH) signaling. PTH,
the main secretory product of parathyroid glands is responsible for regulation of
calcium-phosphate homeostas1 expand
Background: Parathyroid disorders are very common in the general population and include disorders of parathyroid excess, deficiency, or defects in parathyroid hormone (PTH) signaling. PTH, the main secretory product of parathyroid glands is responsible for regulation of calcium-phosphate homeostasis. Objective: i) To investigate the cause of parathyroid disorders ii) To describe evolution, natural history, and longitudinal trends of parathyroid and related disorders seen in syndromic presentations like multiple endocrine neoplasia, hyperparathyroidism-jaw tumor syndrome Eligibility: People ages 6 months older who have, are at risk of having, or are related to a person with a parathyroid or related disorder. Design: Participants will be screened with a review of their medical records. Participants will be seen, tested, and treated by doctors based on their condition. Their visits may be in person or via telehealth. Participants will complete questionnaires. They will answer questions about their physical, mental, and social health. Participants may give samples such as saliva, blood, urine, or stool. Participants may give cheek cell samples. They will do this using a cheek swab or by spitting into a cup. Adult participants may give a skin biopsy. For this, a small bit of skin is removed with a punch tool. Participants may have medical photos taken. If participants have surgery during the course of their regular care either at the NIH or at a different hospital or doctor s office, researchers will ask for some of the leftover tissue. Participants will be in the study as long as they are being seen by their doctor. Type: Observational Start Date: Nov 2021 |
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The Use of 124-I-PET/CT Whole Body and Lesional Dosimetry in Differentiated Thyroid Cancer
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Thyroid Cancer
Study rationale
High risk patients with differentiated thyroid cancer (DTC) require therapy with 131 I
under thyroid stimulating hormone (TSH) stimulation. There are two methods of TSH
stimulation endogenous by thyroid hormone withdrawal (THW) leading to hypothyroidism and
exogenous by injection o1 expand
Study rationale High risk patients with differentiated thyroid cancer (DTC) require therapy with 131 I under thyroid stimulating hormone (TSH) stimulation. There are two methods of TSH stimulation endogenous by thyroid hormone withdrawal (THW) leading to hypothyroidism and exogenous by injection of human recombinant TSH (rhTSH Thyrogen). The appropriate 131-I activity utilized for treatment is either based on empiric fixed dosage choice or individually determined activity based on 131 I dosimetric calculations. Although dosimetry utilizing radioactive iodine isotope 131 I enables calculation of maximum safe dose, it does not estimate the tumoricidal activity necessary to destroy the metastatic lesions. The alternative radioactive isotope of iodine -124 I, used for positron emission tomography (PET) imaging, might be used for calculation not only the maximum safe131 I dose, but also to predict the absorbed dose in the metastatic lesions. Study objectives The primary objective of this study is to compare the 124 I -PET/CT lesional and whole body dosimetry in each individual patient with metastatic radioiodine (RAI)-avid thyroid cancer under preparation with rhTSH and THW. The secondary objective is to evaluate the predicted by PET/CT lesional uptake with the early response to therapy. Study design This is a phase 2 pilot prospective cohort study comparing the lesional and whole body dosimetry within each patient undergoing exogenous (rhTSH) and endogenous (THW) TSH stimulation and followed for 5 years. Interventions Each study participant will undergo rhTSH and THW-aided 124 I-PET/CT dosimetric evaluations and will be subsequently treated with THW-aided RAI activity based on dosimetric calculations enabling maximum safe dosage. The patients will be followed in 12+/-3 months intervals for 5 years. Sample size and population This pilot study will include 30 patients with high risk differentiated thyroid cancer presenting with distant and/or loco-regional metastases. Type: Interventional Start Date: Jul 2019 |
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Characterization and Treatment of Adolescent Depression
National Institute of Mental Health (NIMH)
Depression
This research study seeks to find causes and treatments of depression in teenagers. The
study goals are to increase our knowledge of treatments for depression and understand how
the brain changes when teenagers have depression. The study will also compare teenagers
with depression to those without1 expand
This research study seeks to find causes and treatments of depression in teenagers. The study goals are to increase our knowledge of treatments for depression and understand how the brain changes when teenagers have depression. The study will also compare teenagers with depression to those without mental health diagnoses. This outpatient study is recruiting participants ages 11-17 who are depressed. They must have a pediatrician or other medical provider, be medically healthy, and able to perform research tasks. They may not currently be hospitalized, psychotic or actively suicidal. Teenagers with depression are eligible even if they are taking medication. The study begins with an evaluation that includes clinical assessment, interviews, and questionnaires. - Visits may include paper-and-pencil and computer tests of mood, memory, and thinking; specialized computer games; and structural and brain imaging. If eligible, study participants may return several times a year for up to two years. This part of the study does not involve treatment. - Participants may be eligible for outpatient treatment for up to 25 weeks. This includes evidenced-based "talk" therapy. Participants may choose either Interpersonal Psychotherapy for Adolescents (IPT-A) or Cognitive Behavioral Therapy (CBT). If indicated, participants may opt to receive standard medication treatments along with psychotherapy. Research includes computer tasks and brain imaging. All clinical evaluations, research tasks and visits are free of cost. Participants are compensated for research activities. Parents and teenager must agree to the teenager s participation in research. The study is conducted at the NIH in Bethesda, Maryland and enrolls participants from the Washington DC Metro region within 50 miles of NIH. Transportation expenses are reimbursed by NIMH. Type: Observational Start Date: Dec 2017 |
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Study of Systemic Lupus Erythematosus
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Systemic Lupus Erythematosus
This protocol will evaluate patients with systemic lupus erythematosus (SLE) and their
relatives to learn more about how the disease develops and changes over time. It will
also study genetic factors that make a person susceptible to SLE.
Patients 3 years of age and older with known or suspected S1 expand
This protocol will evaluate patients with systemic lupus erythematosus (SLE) and their relatives to learn more about how the disease develops and changes over time. It will also study genetic factors that make a person susceptible to SLE. Patients 3 years of age and older with known or suspected SLE and their relatives may be eligible for this study. Patients will be evaluated with a medical history and physical examination, blood and urine tests. Other procedures may include: 1. Electrocardiogram 2. 24-hour urine collection 3. Imaging studies, such as chest and joint X-rays, magnetic resonance imaging (MRI) scans, bone scans, and bone densitometry. 4. Questionnaire about the degree of disease activity, and survey of risk factors for disease complications. 5. Apheresis-Collection of plasma (fluid portion of blood) or blood cells for analysis. Whole blood is collected through a needle in an arm vein. The blood circulates through a machine that separates it into its components. The required component (plasma or cells) is removed and the rest of the blood is returned to the body through the same needle or through a second needle in the other arm. 6. Skin biopsy-Removal of a small skin sample for microscopic analysis. An area of skin is numbed with an anesthetic and a small circular portion (about 1/4 inch in diameter) is removed, using a sharp cookie cutter-type instrument. 7. Kidney, bone marrow or other organ biopsy-Removal of a small sample of organ tissue. These biopsies are done only if they can provide information useful in better understanding the disease or making treatment decisions. 8. Genetic studies-Collection of a blood sample for gene testing. Patients will be followed at least once a year with a brief history and physical examination and routine blood and urine tests. Some patients may be seen more often. Treatment recommendations will be offered to patients' physicians, and patients who are eligible for other research treatment studies will be invited to enroll. Participating relatives of patients will fill out a brief medical history questionnaire and provide a DNA sample (either a blood sample or tissue swab from the inside of the cheek) for genetic testing. Type: Observational Start Date: Feb 1994 |
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Improving Barriers to Care Access for Children With Autism and Related Needs Via Telehealth for Eva1
University of Minnesota
Autism Spectrum Disorder
The objectives of the current project are to develop and implement training with
community providers to evaluate a supplemental parent coaching intervention delivered via
telehealth to improve child communication and behavioral outcomes, parental stress
outcomes, and to investigate telehealth model1 expand
The objectives of the current project are to develop and implement training with community providers to evaluate a supplemental parent coaching intervention delivered via telehealth to improve child communication and behavioral outcomes, parental stress outcomes, and to investigate telehealth models to reach children in geographically dispersed or highly mobile locations and/or from military connected families. Type: Interventional Start Date: Jul 2025 |
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Pulmonary Embolism and Right-to-Left Shunts
Tufts Medical Center
Pulmonary Embolism (PE)
Right-to-Left Shunt
Stroke
Atrial Septal Defects
Patent Foramen Ovale (PFO)
Every fetus has a small hole in their heart, called a foramen ovale when they are
developing in the womb. For most people this hole closes shortly after birth, but it
doesn't close completely in 1 out of every 4 people. This is called a "patent" foramen
ovale, or PFO. In people with a PFO it is pos1 expand
Every fetus has a small hole in their heart, called a foramen ovale when they are developing in the womb. For most people this hole closes shortly after birth, but it doesn't close completely in 1 out of every 4 people. This is called a "patent" foramen ovale, or PFO. In people with a PFO it is possible for a blood clot in a vein to enter the heart, pass through the opening, and then go into an artery - this is referred to as a paradoxical embolism which passes through a "Right-to-Left Shunt," or RLS. If this occurs, the blood clot can cause a stroke. The most common RLS (more than 90%) is a PFO. Much rarer causes include other types of holes in the heart (like an atrial septal defect, or ASD), or a vascular communication in the lungs (like a pulmonary arteriovenous malformation, or AVM). We are investigating whether people with a PE are at higher risk of stroke if they happen to have an RLS compared to PE patients who don't have an RLS. This study will simply observe and compare the differences in stroke-related outcomes between those 2 groups. Participation in the study last roughly 90-days and includes the following activities: - The study team will review your medical records to collect general information such as your age, sex, race/ethnicity, height, weight, medications, medical history, and other medical information - Magnetic Resonance Imaging (MRI) of your brain will be done as soon as possible following your enrollment in the study. For more information on MRI scans, please see the "MRI scan" section below. - A Transcranial Doppler (TCD) with bubble study will be performed to determine if an opening is present in your heart or lungs. TCD is performed using ultrasound. A contrast called agitated saline will be injected into your vein for this test. - You will be asked to return for a follow-up visit 90 days after your pulmonary embolism. At this visit, the following will occur: 1. A second MRI of your brain will be performed. 2. You will complete a questionnaire to evaluate whether you may have had a stroke since being discharged from the hospital 3. You will meet with a member of the study team who will collect information about your health status. Type: Observational Start Date: Jan 2026 |
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Preoperative Exercise Testing and Perioperative Outcomes
Yale University
Postoperative Complications (Cardiopulmonary)
The goal of this observational study is to learn whether results from a brief exercise
test done before surgery can help identify adults who may be more likely to have problems
after moderate- to high-risk noncardiac surgery. The study includes adults older than 45
years who are seen in a pre-surgi1 expand
The goal of this observational study is to learn whether results from a brief exercise test done before surgery can help identify adults who may be more likely to have problems after moderate- to high-risk noncardiac surgery. The study includes adults older than 45 years who are seen in a pre-surgical evaluation clinic and complete submaximal cardiopulmonary exercise testing, or smCPET, as part of their usual clinical care. The main questions it aims to answer are: Are smCPET measurements linked with early problems after surgery? Are smCPET measurements linked with later problems after surgery, including complications within 30 and 60 days, longer hospital stay, and death? Can smCPET add useful information to standard preoperative risk assessment? Researchers will observe and analyze information collected during routine care. No extra exercise testing or treatment will be done for research. Participants will: - Complete routine preoperative evaluation in the Yale Pre-Surgical Evaluation Clinic. - Undergo smCPET if it is ordered as part of standard clinical care. - Allow researchers to collect information from the medical record and from the exercise test for the study repository, if they agree to participate. The study will collect de-identified information about each participant's health before surgery, exercise test results, details about the surgery and hospital stay, and problems that happen after surgery. This may include age, sex, body mass index, other medical conditions, routine lab and imaging results, heart rate, blood pressure, oxygen levels, smCPET measures such as peak oxygen uptake, anaerobic threshold, and breathing efficiency, and early and late postoperative outcomes. Researchers will look at short-term and later outcomes after surgery. These include problems identified during the hospital stay, such as heart, lung, kidney, nerve, blood, wound, and pain-related complications, as well as complications within 30 and 60 days after surgery. Researchers will also study hospital length of stay and death after surgery. This study is designed to help researchers understand whether a short, practical exercise test can improve the way surgical risk is assessed before an operation. Current preoperative assessment tools do not always measure how well the heart, lungs, and muscles work together during physical stress. smCPET may provide a more objective way to measure functional capacity and physiologic reserve in a busy clinic setting. This is a single-center study based in a preoperative evaluation clinic. The study has a prospective observational cohort component and a retrospective validation component. In the prospective part, adults who meet clinic criteria and complete smCPET during routine care may be asked to join the repository. In the retrospective part, researchers may also review historical data from patients evaluated before smCPET was put into routine use to help compare outcomes and validate findings. Because this is an observational repository study, participation does not change the care participants receive. The exercise test is done for clinical reasons, not because of the research study. The research team will not assign treatments or decide what surgery a participant has. Instead, the team will study how exercise test findings relate to outcomes that occur after surgery. The long-term aim of this study is to improve preoperative risk assessment and help clinicians better identify patients who may need closer monitoring, more evaluation, or more support around the time of surgery. If the findings are useful, they may support broader use of brief preoperative exercise testing in adults having higher-risk noncardiac surgery. Type: Observational [Patient Registry] Start Date: Jul 2025 |
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Steady Together Fall Prevention Program in the Home
Cleveland State University
PARKINSON DISEASE (Disorder)
The purpose of the research study is to assess the efficacy of the occupational therapy
Steady Together Fall Prevention Program in the Home for persons with Parkinson's Disease
(PwP) who are members of InMotion. InMotion is a community wellness center that offers a
variety of programs for PwP. The1 expand
The purpose of the research study is to assess the efficacy of the occupational therapy Steady Together Fall Prevention Program in the Home for persons with Parkinson's Disease (PwP) who are members of InMotion. InMotion is a community wellness center that offers a variety of programs for PwP. The goal of the program is to prolong safe and independent living of PwP within their homes through fall prevention. Objectives are: 1) to identify areas in the home that are barriers to safe and accessible functioning for PwP with a focus on fall prevention; 2) To recommend assistive equipment, performance strategies, and home modifications as well as helpful resources to enhance safety and accessibility within the home. 3) to improve accessibility of the home; 4) to improve the PwP's safety confidence within their home. Research questions are: 1. Do participants have improved safety confidence in their homes as relates to falls after completing the program 2. Is home more accessible after completing program 3. What areas of the home pose the most fall risk among this population 4. What types of modifications and assistive devices help to reduce falls among this population 5. Does the program help to reduce falls among this population Participants will complete an initial intake form (30 minutes); they will participate in a 2 hour home assessment performed by occupational therapists using the Home for Life Design (HfLD platform in which they will be asked to identify areas of their home they have fall safety concerns; they will rate the safety of these spaces; they will demonstrate activities of daily living done in spaces and the occupational therapist will rate accessibility of these spaces; they will participate in a 30 minute meeting with the occupational therapist to review report with recommendations and resources and develop an agreed upon action plan; they will implement action plan; they will participate in a one hour reassessment; participate in a follow up 30 minute phone interview one year later. Total time commitment is 4 hours. Type: Interventional Start Date: Apr 2026 |
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Accurate Point of Care Liver Disease Diagnostics (Phase 2)
University of California, San Diego
MASLD
MASLD (Metabolic Dysfunction-Associated Steatotic Liver Disease)
NAFLD
NAFLD (Nonalcoholic Fatty Liver Disease)
This research study is being conducted to find out more about techniques to
non-invasively evaluate liver disease. This is the second phase of a project in which we
are testing a new technology to evaluate the liver (LiverScope®). We will compare
LiverScope® to other methods to evaluate the liver,1 expand
This research study is being conducted to find out more about techniques to non-invasively evaluate liver disease. This is the second phase of a project in which we are testing a new technology to evaluate the liver (LiverScope®). We will compare LiverScope® to other methods to evaluate the liver, including advanced conventional liver MR exams. MR exams are common exams used to monitor MASLD (also known as NAFLD). Conventional MR scanners use magnetic fields and radio waves to make pictures of the liver. LiverScope® is a small, portable MR-based device that uses similar, but simplified technology, and can be used on top of an exam table in an outpatient setting. LiverScope® currently is not approved for clinical use. In this second phase of the study, we took what we learned in the first phase to optimize the LiverScope® device and are now testing to see how LiverScope® measurements compare to MR after these optimizations. Study participants will be asked to complete a one-time visit which includes: - LiverScope exam - MR exam - FibroScan exam (optional) - Blood draw - Completion of study questionnaires Type: Observational Start Date: Apr 2026 |
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A Study of Ivonescimab in People With Leiomyosarcoma
Memorial Sloan Kettering Cancer Center
Leiomyosarcoma
The purpose of this study is to find out if Ivonescimab is an effective and safe
treatment that causes few or mild side effects for people with advanced/unresectable
leiomyosarcoma. expand
The purpose of this study is to find out if Ivonescimab is an effective and safe treatment that causes few or mild side effects for people with advanced/unresectable leiomyosarcoma. Type: Interventional Start Date: Apr 2026 |
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Spinal Cord Stimulation for Children With Cerebral Palsy
Martin Piazza
Cerebral Palsy
Spasticity
The goal of this clinical trial is to help understand spinal cord excitability in
children with cerebral palsy compared to neurologically typical children. The main
questions it aims to answer are:
- What are the mechanisms of spinal circuit hyperexcitability in CP?
- Can transcutaneous spi1 expand
The goal of this clinical trial is to help understand spinal cord excitability in children with cerebral palsy compared to neurologically typical children. The main questions it aims to answer are: - What are the mechanisms of spinal circuit hyperexcitability in CP? - Can transcutaneous spinal cord stimulation reduce spinal circuit hyperexcitability? Participants with cerebral palsy will be asked to complete: - Movement and strength exercises - Mild, non-invasive stimulation on the back and legs that feels like a light tap. - Gentle, non-invasive tests that help us see how the brain and the spinal cord communicate with the muscles Type: Interventional Start Date: Mar 2026 |
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A Phase 1 Study of 177Lu-IM-3050 in Participants With Advanced Cancer
Immunome, Inc.
Solid Malignancies
IM-3050-101 is a Phase 1 study to determine the safety and effectiveness of 177Lu-IM-3050
in treating participants with advanced cancer. expand
IM-3050-101 is a Phase 1 study to determine the safety and effectiveness of 177Lu-IM-3050 in treating participants with advanced cancer. Type: Interventional Start Date: Apr 2026 |
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Phase 2 Trial of Icovamenib in Participants With Type 2 Diabetes Mellitus Who Are Not Achieving Gly1
Biomea Fusion Inc.
Type 2 Diabetes
This is a phase 2 randomized, double-blind, placebo-controlled trial assessing the
efficacy and safety of icovamenib in participants with Type 2 Diabetes (T2D) not
achieving glycemic targets despite Ozempic-based therapy. expand
This is a phase 2 randomized, double-blind, placebo-controlled trial assessing the efficacy and safety of icovamenib in participants with Type 2 Diabetes (T2D) not achieving glycemic targets despite Ozempic-based therapy. Type: Interventional Start Date: Apr 2026 |
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Phase 2 Trial of Icovamenib in Participants With Type 2 Diabetes Who Are Not Achieving Glycemic Tar1
Biomea Fusion Inc.
Type 2 Diabetes
This is a Phase 2, randomized, double-blind, placebo-controlled trial assessing the
efficacy and safety of icovamenib in participants with Type 2 Diabetes who are not
achieving glycemic targets despite antihyperglycemic medications. expand
This is a Phase 2, randomized, double-blind, placebo-controlled trial assessing the efficacy and safety of icovamenib in participants with Type 2 Diabetes who are not achieving glycemic targets despite antihyperglycemic medications. Type: Interventional Start Date: Mar 2026 |