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Намерени 4,781 изпитвания Стр. 9 от 240

By invitation only

Gene Therapy Follow up Protocol for Subjects Previously Enrolled in NCI Center for Immuno-Oncology Studies

Cervical Intraepithelial Neoplasia Cervical Neoplasms Oropharyngeal Neoplasms Squamous Intraepithelial Lesions of the Cervix +1

Background: Gene therapy is closely followed by the U.S. Food and Drug Administration (FDA). The FDA requires researchers to conduct long-term follow-up of people who have had the treatment. This study collects data on people who have had gene therapy and sends it to the FDA. The data does not include participants names. Objective: To contact current or past participants of gene therapy protocols at least once a year for up to 15 years to ensure they have not had any harmful side effects. Eligibility: People aged 18 and older who have had gene therapy in a National Cancer Institute study Design: Participants will give their address and telephone number. They will also give and the address and phone number of 1 or 2 other people who will know where they are. For the first year after gene therapy, participants will give blood samples 3 times (at 3, 6, and 12 months). For the next 4 years, they may have a physical exam and laboratory tests with a home physician. They will get a kit to mail in blood samples. Or they can visit the NIH Clinical Center. They will be asked if they have had any signs of neurological, autoimmune, or blood disorders, or any new cancers. For years 6 to 15, participants will be contacted yearly via phone or email and asked questions about their health. They may give blood samples. When the participant dies, if researchers think the death was caused by gene therapy, they will ask the participant s family to allow an autopsy. ...

Начало: 08.05.2020 Край: 01.10.2050 Възраст: 18–120 г.

United States National Cancer Institute (NCI) NCT04266093

By invitation only

Activity Monitors as a Measure of Physical Function in Degenerative Cervical Myelopathy

Cervical Myelopathy

The investigators objective of this research is to compare activity monitor results with standard of care (SOC) question-based outcome measures for degenerative cervical myelopathy patients before and after treatment with decompression. Understanding of the relationship between activity monitor data and question-based outcome measures in the context of degenerative cervical myelopathy will improve our understanding of the disease and limit the effort to diagnose and monitor it.

Начало: 13.08.2018 Край: 01.08.2027 Възраст: 18–90 г.

United States University of Utah NCT04498806

By invitation only

Fusion Guided Focal Laser Ablation of Prostate Cancer

Prostate Cancer Prostate Neoplasms

Background: Prostate cancer is the most common non-skin cancer in U.S. men. Treatments for early or less aggressive disease are limited. Researchers want to test a device that destroys cancerous tissue with laser energy. They want to see if using it with ultrasound is more comfortable than using it with magnetic resonance imaging (MRI). Objectives: To test a cooled laser applicator system to treat prostate cancer lesions. To see if ultrasound imaging is a practical and feasible treatment with laser ablation for focal prostate cancer treatment. Eligibility: Men at least 18 years old with prostate cancer seen on MRI that has not spread in the body. Design: Participants will be screened with standard cancer care tests. These can include physical exam, lab tests, and MRI. For the MRI, they lie in a machine that takes pictures. Participants will have a prostate biopsy. Needle samples will be taken from 12 places in the prostate. This will be guided by MRI and ultrasound, which is obtained through a coil in the rectum. Participants will stay at the clinic for 1 2 days. A cooling catheter (plastic tube) will be put in the bladder. Ultrasound will guide the laser applicator directly to the tumor. The cooling catheter will be removed. A different catheter will be put in the urethra to keep the bladder emptied. The next day, participants will have a physical exam and a PSA blood test. Participants will have 6 follow-up visits over 3 years. At each visit, they will have a physical exam and lab tests. At some visits, they will also have an MRI or other scans and a prostate biopsy.

Начало: 13.10.2017 Край: 21.01.2027 Възраст: 18–100 г.

United States National Institutes of Health Clinical Center (CC) NCT02759744

By invitation only

Leukapheresis for CAR or Adoptive Cell Therapy Manufacturing

Leukemia Lymphoma Acute Lymphoblastic Leukemia Diffuse Large B Cell Lymphoma +1

Background: Leukapheresis is a procedure to separate and collect white blood cells. It is the first step in a treatment called CAR (chimeric antigen receptor) T-cell therapy. CAR-T therapy may be offered to people when their cancer comes back. The collected T-cells are used to make a special version of T-cells called CARs. Researchers want to collect these cells from people who may become eligible for a CAR T-cell study in the future. Objective: To identify people who have a high likelihood to benefit from CAR T-cell therapy early in their disease course and collect and store a T-cell product. Eligibility: People ages 3-65 with a form of leukemia or lymphoma that has not been cured by standard therapy Design: Participants will be screened with medical history, physical exam, and blood and urine tests. Review of existing MRI, x-ray, pathology specimens/reports or CT images may be done. On this study, participants will have leukapheresis. A needle will be placed into the arm. Blood will be collected and go through a machine. White blood cells will be taken out by the machine. The plasma and red cells will be returned to the participant through a second needle in the other arm. The procedure will take 4-6 hours. Some participants may have a central line (catheter) inserted which is needed to do the leukapheresis procedure, instead of the needles in the arms-especially if they are smaller. For a central line placement, a long thin tube is inserted through a small incision into the main blood vessel leading into the heart that would allow access to the blood to do the leukapheresis procedure. Participants cells will be processed and frozen for future use in a CAR T-cell therapy study.

Начало: 14.08.2017 Край: 31.07.2030 Възраст: 3–65 г.

United States National Cancer Institute (NCI) NCT03226704

By invitation only Phase 1

Immunogene-modified T (IgT) Cells Against Glioblastoma Multiforme

Glioblastoma Multiforme of Brain Brain Cancer

This study aims to treat patients who have been diagnosed with brain cancer glioblastoma multiforme (GBM) including diffuse intrinsic pontine glioma (DIPG) and diffuse midline glioma (DMG). The treatment combines two different approaches to fight cancer: immune modulators and antigen-specific T cells. Immune checkpoint antibodies have been tested on various tumors with good outcomes. GBM is known to express increased levels of certain antigens that can be targeted by T cells including chimeric antigen receptor-modified T (CAR-T) cells and tumor antigen specific cytotoxic lymphocytes (CTLs). In this study, the gene-modified T cells specific for GBM antigens will be combined with immune modulatory gene-modified dendritic cells (DCs) as individualized treatment regimens to treat patients.

Начало: 31.05.2017 Край: 31.12.2027 Възраст: 6–70 г.

China Shenzhen Geno-Immune Medical Institute NCT03170141

By invitation only

Predicting Cardiometabolic Risk in Mild-to-Moderate Obstructive Sleep Apnea: Inflammation vs. Apnea/Hypopnea Index

Obstructive Sleep Apnea

The purpose of the study is to compare the relative contribution of systemic inflammation vs. Obstructive Sleep Apnea (OSA) severity (as measured by Apnea Hypopnea Index) in predicting cardiovascular and metabolic aberrations associated with mild-to-moderate obstructive sleep apnea.

Начало: 01.03.2017 Край: 01.12.2027 Възраст: от 18 г.

United States Milton S. Hershey Medical Center NCT03062748

By invitation only Phase 2

Effects of Bronchial Segmental Endotoxin Instillation in Humans

Acute Lung Inflammation

Background: \- When bacteria enter the lungs, serious infections can occur. Researchers want to learn more about the process of inflammation in the lungs by studying lung cells and the products that they make. Lung cells are influenced by infections, smoking, and molecules made within the body. Researchers also want to learn more about one of these molecules, called microRNA (or micro ribonucleic acid). Objective: \- To better how the body responds to infection. Also, to understand which cells in the lung secrete microRNA and how they may influence other lung cells. Eligibility: \- Healthy, non-smoking adults ages 18-45. Design: * Participants will be screened with a medical history and physical exam. They will have blood and urine tests and an electrocardiogram. * Participants will have blood drawn from an arm vein. They will have an intravenous catheter (small plastic tube) placed in a vein. * All participants will have bronchoscopy with bronchoalveolar lavage. They will be numbed with medicine. A thin flexible tube will be placed through the nasal passages or the mouth into the airways of the lung. * Some participants will have bronchoscopy with bronchoalveolar lavage (rinsing the airways with salt water) in order to obtain cells from lung. The water will then be suctioned out. * Some participants will have two bronchoscopies; during the first procedure, endotoxin, a molecule found in bacteria is squirted into a small portion of the lung. Endotoxin is a molecule that acts like an infection but isn t one. After 6 to 48 hours, bronchoscopy with with bronchoalveolar lavage will be done to look at the lung s response to endotoxin. * Participants heart rhythm and rate, temperature and blood oxygen level will be monitored during the procedures. * Participants will be called the next day to see how they are feeling.

Начало: 18.06.2015 Край: 30.06.2027 Възраст: 18–45 г.

United States National Institutes of Health Clinical Center (CC) NCT02392442

By invitation only

Studies of the Human Microbiome in Clinical Center Patients

Multidrug-resistant Colonization

Background: \- The intestines, mouth, and skin all contain billions of bacteria and some fungi. Every person s body contains microorganisms like these. They normally do not make people sick. Researchers are interested in how these microorganisms change when a person is hospitalized. They want to find out if changes take place because of the hospitalization (such as treatments used or changes in medical condition) or because of a person s biology (such as their immune system). Objectives: \- To understand which microorganisms are most likely to spread through hospitals and what affects that spread. Eligibility: \- People 2 years of age and older who are going to be inpatients at the National Institutes of Health Clinical Center (NIHCC) for at least 48 hours. Design: * Clinicians will take samples from participants up to once a day for as long as they are hospitalized at NIHCC. * Samples will be taken with a swab, from the rectal area, groin, throat, and armpit, and possibly other areas. * Participants may give a stool sample or be asked to spit into a cup. * Clinicians will collect some information from participants medical records. They may request some samples of tissue that are left over from procedures already scheduled at NIHCC. * After participants leave the NIHCC, samples may be taken when they return for follow-up visits from their hospitalization, for up to 2 years. They will not have to return as a follow-up for this study only.

Начало: 28.01.2014 Възраст: 2–120 г.

United States National Institutes of Health Clinical Center (CC) NCT01933620

By invitation only

Ultrahigh Field Body MR Imaging

Structure and Function of MRI

The primary objective of this study is to develop new ways to acquire MRI data and/or new ways to analyze the acquired data.

Начало: 21.02.2013 Край: 31.01.2029 Възраст: 18–75 г.

United States University of Minnesota NCT02236143

By invitation only

Genetics of Obesity, Diabetes, and Heart Disease in African Diaspora Populations

Diabetes Cardiovascular Disease

Background: \- African Americans have one of the highest rates of type 2 diabetes in the United States, and often have other medical problems related to obesity and cardiovascular disease. These conditions have various risk factors, including high blood sugar levels, high cholesterol levels, and insulin resistance. However, these risk factors have not been studied very closely in individuals with African ancestry, including Afro-Caribbean and sub-Saharan Africa migrant populations. Researchers are interested in conducting a genetic study on obesity, adult-onset diabetes, heart disease, and other common health conditions in individuals with African ancestry. Objectives: \- To collect genetic and non-genetic information from individuals with African ancestry to study common health conditions related to obesity, adult-onset diabetes, and heart disease. Eligibility: \- Individuals at least 18 years of age who self-identify as African American, Afro-Caribbean, or migrants from sub Saharan Africa. Design: * Participants will undergo a physical examination and will provide a blood sample for study. * Participants will also answer questions about personal and family medical history and current lifestyle behaviors. * No treatment will be provided as part of this protocol.

Начало: 06.05.2011 Възраст: 18–120 г.

United States National Human Genome Research Institute (NHGRI) NCT01316783

By invitation only

Follow Up Protocol for Subjects Previously Enrolled on NCI Surgery Branch Studies

Melanoma Adenocarcinoma Carcinoma NOS Neuroendocrine Tumors

Background: The NCI Surgery Branch has developed experimental therapies that involve taking white blood cells from participants' tumor or from their blood, growing them in the laboratory in large numbers, and then giving the cells back to the patient. Objective: This study will allow participants to be followed for up to 15 years following treatment on an NCI Surgery Branch Gene Therapy Trial as required by the FDA. Eligibility: Participants must have been enrolled on an NCI Surgery Branch Gene Therapy Protocol Design Participants will be followed with a physical examination and blood tests for up to 15 years as required by the FDA

Начало: 15.06.2009 Възраст: от 18 г.

United States National Cancer Institute (NCI) NCT00923026

By invitation only

Establishing Fibroblast-Derived Cell Lines From Skin Biopsies of Patients With Immunodeficiency or Immunodysregulation Disorders

Primary Immunodeficiency DOCK8 Virus Susceptibility

Background: * National Institutes of Health (NIH) researchers have been studying immune cells (white blood cells) to better understand how the human body s defense system works and adjusts or regulates itself, and how changes in this system can make a person sick. * To study the cells of patients who have problems with their immune systems, researchers would like to collect samples of skin cells from patients with immune system disorders and compare them with skin cells taken from healthy volunteers. By studying these cells, researchers hope to determine whether these cells can be modified to create a new kind of personalized gene therapy that would attempt to cure immune diseases in the future. Objectives: * To obtain skin cells from patients with immune system disorders and from healthy volunteers for research and comparison purposes. Eligibility: * Patients between the ages of 2 and 85 who have immune system disorders. * Healthy volunteers between the ages of 18 and 85. * Both groups will be selected from the eligible participants of existing NIH studies into immune system disorders. Design: * Researchers may take up to two biopsies from participants arms, legs, abdomen, or back. * The biopsy site will be numbed with local anesthetic and cleaned before the sample is taken. * The punch skin biopsy needle will be inserted into the skin and rotated to remove a small circle of skin (approximately 1/4 to 3/8 of an inch across). The area will be closed with bandages or stitches, and then covered with a dressing. Any stitches will be removed in 7 to 10 days. * Tissue samples collected in the study will be stored for future research.

Начало: 10.06.2009 Възраст: 2–85 г.

United States National Institute of Allergy and Infectious Diseases ( NCT00895271

By invitation only

Establishment of Cell Culture Systems From Discarded Operating Room Tissue

Surgery

The purpose of this study is to establish viable cell culture system techniques for a variety of healthy and diseased tissues for use in future in vitro and in vivo research studies in tissue engineering.

Начало: 01.02.2009 Край: 01.12.2035 Възраст: 28–80 г.

United States Wake Forest University Health Sciences NCT01000077

By invitation only

Use of Tracking Devices to Locate Abnormalities During Invasive Procedures

Adenocarcinoma Prostate Neoplasms Prostate Cancer Renal Cell Carcinoma +1

This study will evaluate the accuracy and effectiveness of an experimental tracking device for locating abnormalities during invasive procedures, such as biopsy or ablation, that cannot easily be visualized by usual imaging techniques, such as computed tomography (CT) scans or ultrasound. Some lesions, such as certain liver or kidney tumors, small endocrine abnormalities, and others, may be hard to find or only visible for a few seconds. The new method uses a needle with a miniature tracking device buried inside the metal that tells where the tip of the needle is located, somewhat like a mini GPS, or global positioning system. It uses a very weak magnet to localize the device like a miniature satellite system. This study will explore whether this system can be used in the future to more accurately place the needle in or near the desired location or abnormality. Patients 18 years of age and older who have a lesion that needs to be biopsied or an ablation procedure that requires CT guidance may be eligible for this study. Candidates are screened with a medical history and review of medical records, including imaging studies. Participants undergo the biopsy or ablation procedure as they normally would, with the following exceptions: some stickers are placed on the skin before the procedure and a very weak magnet is placed nearby. The needles used are similar to the ones that would normally be used except that they contain a metal coil or spring buried deep within the needle metal. The procedure involves the following steps: 1. Small 1-cm plastic donuts are place on the skin with tape. 2. A planning CT scan is done. 3. The CT scan is sent to the computer and matched to the patient's body location with the help of a very weak magnet. 4. The needle used for the procedure is placed towards the target tissue or abnormality and the "smart needle" location lights up on the old CT scan. 5. A repeat CT is done as it normally is to look for the location of the needle. 6. After the procedure the CT scans are examined to determine how well the new tool located the needle in the old scan....

Начало: 23.02.2005 Край: 02.06.2026 Възраст: 18–120 г.

United States National Institutes of Health Clinical Center (CC) NCT00102544

By invitation only

Data Collection, Clinical Care and Interventions in CCR, NCI

Neoplasms Cancer

This study provides cancer care through the National Cancer Institute's Medical Oncology Branch (MOB) to patients who are not enrolled in an active treatment research protocol. Patients receive standard treatments only; no investigational therapies are provided on this protocol. Patients 18 years of age and older may be eligible for this protocol. Candidates are patients for whom an NCI investigator decides that the interests of the patient and the NCI are best served by the patient's enrollment in this protocol to receive care and follow-up within the MOB. This includes patients in the following categories: * Patients previously enrolled in NCI trials whose participation in this protocol may continue to provide researchers important scientific information * Patients who will be eligible for a research protocol within the foreseeable future * Patients whose medical welfare will be seriously compromised by referral back to the community, such as patients with a rare or complex disease for which community resources are inadequate or unavailable * Terminally ill patients who have received most of their specialized medical care at the Clinical Center and for whom humanitarian considerations dictate that they continue to receive their medical care at NIH after going off study for the remaining weeks or months of life * Patients with cancer or HIV, or people at risk for cancer or HIV for whom cancer treatments at the NCI are requested through the MOB consult service * Patients who are participating in a non-treatment NCI research protocol and require standard-of-care therapy * Patients with cancer or HIV or people at risk for cancer for whom cancer treatment or management at the NCI would add significant value to the institute's cancer training program Participants receive standard medical care, including periodic routine laboratory tests, diagnostic x-rays, and nuclear medicine scans to monitor the course of illness and the effects of any treatment.

Начало: 10.06.2004 Възраст: 4–120 г.

United States National Cancer Institute (NCI) NCT00923065

By invitation only

Biology Studies of Hematologic Cancers

Acute Lymphoblastic Leukemia Myelodysplastic Syndrome (MDS) Non-Hodgkins Lymphoma Acute Myelogenous Leukemia +1

This study will collect tumor samples from people with cancers of the blood, bone marrow, or lymph glands for laboratory study of the biology of these conditions. Such studies contribute to a better understanding of cancer biology and to the development of new treatments. Planned studies include: * Examination of individual cancer cells and to search for differences compared to other types of cancer and normal cells * Examination of the chromosomes and genes in cancer cells and to search for differences compared to other types of cancer and normal cells * Development of sensitive methods to detect small amounts of cancer that remain after treatment * Search for new cancer proteins that might serve as targets for treatment * Investigation of methods to develop cancer vaccines. Patients from \>= 1 to 75 years of age with acute lymphocytic leukemia, acute myelogenous leukemia, myelodysplastic syndrome, chronic myelogenous leukemia, juvenile myelomonocytic leukemia, non-Hodgkin's lymphoma, Hodgkin's disease, and other hematologic malignancies may be eligible for this study. Blood or bone marrow samples will be collected when sampling is required for the patient's medical care. Cells from some individuals will be grown in test tubes, establishing cell lines or in animals, establishing xenograft models. (A xenograft is transplantation of cells of one species to another species.)

Начало: 24.02.2004 Възраст: 1–120 г.

United States National Cancer Institute (NCI) NCT00923442

By invitation only

Screening for Hematology Branch Protocols

Hematologic Disease and Disorders Donors Healthy Volunteer

This study allows the evaluation of subjects in order to determine their ability to safely participate in other active research studies. After subjects complete the screening process, they will be offered the opportunity to participate in an active research study, or if no appropriate studies are available information and recommendations will be provided for other treatment options....

Начало: 31.12.1996 Възраст: 2–100 г.

United States National Heart, Lung, and Blood Institute (NHLBI) NCT00001620

By invitation only

Genetic Studies of Lysosomal Storage Disorders

Lysosomal Storage Disorders Gaucher Disease Parkinson Disease

The purpose of this study is to identify genetic, biochemical, and clinical factors that are associated with disease severity in people with Gaucher disease and other lysosomal storage disorders. There is a vast spectrum of clinical manifestations in people with Gaucher disease as well as other lysosomal storage disorders. This study will evaluate patients with lysosomal disorders on an outpatient or inpatient basis in order to better characterize the clinical, genetic, and pathophysiological features of these disorders. Participants will be re-evaluated on an annual basis....

Начало: 08.03.1995 Възраст: от 1 г.

United States National Human Genome Research Institute (NHGRI) NCT00001215

By invitation only

Evaluation and Long-Term Follow-up of Patients With Inflammatory Disorders

Inflammation

This study will investigate inflammatory diseases and disorders. Inflammation is the body s immune response to many things, including infections and other acute or chronic irritants. It may also be a sign of abnormal immune function. This study will allow evaluation and long-term follow-up of such disorders to: * Establish and maintain a group of patients that may be eligible for other NIAID protocols. * Provide clinical training and experience for NIAID fellows. * Provide a mechanism for NIAID staff to maintain their clinical skills. * Serve as a starting point for new investigations of syndromes not currently under study. Patients between 1 and 80 years of age with acute or chronic inflammation, including but not limited to viral, fungal or bacterial infections, or abnormal immune responses may be eligible for this study. Immediate family members of patients may also be enrolled for preliminary examination to see if they are affected in any way that may warrant further investigation. All patients and family members will have a history, physical examination and laboratory tests. Depending on the results, family members may require additional tests. Patients will have additional diagnostic tests indicated for their specific disease, according to accepted medical standards. These may include routine blood and urine tests, X-rays or other imaging studies, body fluid or tissue cultures, skin tests for allergic or immune responses, and others as needed. Treatments will include only medications approved by the Food and Drug Administration according to accepted dose schedules and delivery methods. Patients may be requested to donate extra blood for research studies. No more than 450 cc (30 tablespoons) will be drawn from adults within a 6-week period, and no more that 7 cc (1/2 tablespoon) from children under 18 years of age in the same time period. ...

Начало: 01.06.1993 Възраст: от 2 г.

United States National Institute of Allergy and Infectious Diseases ( NCT00001351

Available

Expanded Access Program of AMTAGVI That is Out of Specification for Commercial Release

Unresectable Melanoma Metastatic Melanoma

The objective of this expanded access protocol is to provide access to Out Of Specification (OOS) AMTAGVI treatment to patients.

Възраст: от 18 г.

United States Iovance Biotherapeutics, Inc. NCT05398640

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