[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"National Heart, Lung, and Blood Institute (NHLBI)\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":633},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,62,0,25,[9,53,82,105,130,152,180,203,232,257,281,305,325,351,376,396,422,447,470,491,515,541,566,590,610],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":4,"eligibilityCriteria":16,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":29,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":41,"lastUpdatePostDateStruct":42,"startDateStruct":45,"completionDateStruct":47,"leadSponsor":49,"locationsCount":52},"100648017","plasma-lipids-dependent-vitamin-e-metabolism-during-dynamic-hyperlipidemia-100648017",false,"NCT07715890","Plasma Lipids-Dependent Vitamin E Metabolism During Dynamic Hyperlipidemia","Plasma Lipids-dependent Vitamin E Metabolism During Dynamic Hyperlipidemia","* INCLUSION CRITERIA\n\nCohort 1\n\n1. Males and females between the ages of 18 to 65\n2. BMI 18.5 - 26.9 kg\u002Fm\\^2\n3. Subject understands the protocol and provides written, informed consent in addition to a willingness to comply with specified follow-up instructions and evaluations\n4. Normotensive, not on medications for hypertension\n5. Not on glucose-lowering or lipid-lowing medications\n6. Screening labs with baseline HbA1c \\\u003C5.7%, baseline fasting triglyceride \\\u003C 150 mg\u002FdL and LDL \\\u003C100 mg\u002FdL\n7. Liver fat \\\u003C2%\n\nCohort 2\n\n1. Males and females between the ages of 18 to 65\n2. BMI \\>26 kg\u002Fm\\^2 and \\\u003C36 kg\u002Fm\\^2\n3. Subject understands the protocol and provides written, informed consent in addition to a willingness to comply with specified follow-up instructions and evaluations.\n4. Screening labs with baseline HbA1c \\\u003C= 7.5%, agree to be off or stop oral glucose-lowering medications (metformin), baseline fasting triglyceride \\\u003C 500 mg\u002FdL and LDL \\\u003C190 mg\u002FdL, agree to be off or stop oral lipid-lowing medications for 4-10 weeks prior to the inpatient visit.\n5. Liver fat \\\u003C2%\n\nEXCLUSION CRITERIA\n\n1. For women: pregnancy or currently breastfeeding\n2. Subjects \\\u003C18-year-old. This age group has a broad spectrum of hormonal profiles, due to development and puberty, which significantly increases the heterogenicity of the study subjects.\n3. Subjects \\>65-year-old. This age group has significantly increased risk of cardiovascular diseases. To minimize the risk from temporarily suspending lipid- and glucose-lowering medications and stress from serial blood draws, we exclude these individuals.\n4. Heavy alcohol user (males with \\>2 drinks per day or \\>14 drinks per week; female with \\>1 drinks per day or \\>7 drinks per week)\n5. Current smoker, or former smoker who quit smoking \\\u003C15 years ago\n6. Subjects with weight changes greater than 20% baseline body weight over the past 3 months\n7. Subjects with lactose intolerance unwilling to take lactase\n8. Subjects with type 1 diabetes\n9. Subjects with hemoglobin \\\u003C11 g\u002FdL or hematocrit \\\u003C33%\n10. Subjects with abnormal liver function test results\n11. Subjects with liver fat \\>= 2% on abdominal MRI\n12. Subjects with a history of pancreatitis, diabetes ketoacidosis, hyperosmolar hyperglycemic state, advanced atherosclerosis, cardiovascular diseases, kidney diseases, or liver diseases\n13. Subjects with fat malabsorption including: history of gastrointestinal surgery, pancreatic insufficiency, inflammatory bowel disease, celiac disease, moderate-to-severe irritable bowel syndrome, and pathologic mutations impacting lipoprotein metabolism\n14. Subjects on glucocorticoids \\>1 week (not including topical glucocorticoids)\n15. Subjects with HIV\n16. Subjects with uncontrolled psychiatric and\u002For behavioral disorders\n17. Subjects taking diabetes medications other than metformin\n18. Anticipated surgery during the study period\n19. Subjects with severe medication-resistant claustrophobia\n20. Subjects who are unwilling to stop medications, vitamins and\u002For dietary supplements that investigators have requested to be held\n21. Subjects participating in any other clinical study without informing investigators\n22. Any other reason or clinical condition that the investigators judge would interfere with study participation and\u002For be unsafe for a participant or staff member","ALL","18 Years","65 Years",{"count":21,"type":22},48,"ESTIMATED","INTERVENTIONAL",[25],"NA","Background:\n\nObesity is known to lead to diseases such as diabetes and high cholesterol (or fats) in the blood (hyperlipidemia). But no one knows why. Researchers think that high levels of fat in the blood may block important nutrients, such as vitamin E, from reaching places they are needed in the body.\n\nObjective:\n\nTo learn how high-fat meals affect levels of vitamin E in the blood.\n\nEligibility:\n\nPeople aged 18 to 65 with high blood fat levels. Healthy volunteers are also needed.\n\nDesign:\n\nParticipants will have 3 or 4 clinic visits in 3 months. The last visit will require them to stay in the clinic for 2 nights.\n\nParticipants will be screened. They will have a physical exam and blood tests.\n\nAfter this visit, all participants must stop taking any dietary supplements.\n\nThose who use them must also stop taking any drugs to lower their blood sugar and blood fats. These participants will have an extra visit for blood tests after 60 days.\n\nThe next visit will include 2 imaging scans:\n\nMagnetic resonance imaging (MRI) of the abdomen. This scan will check for fat in the liver.\n\nDual-energy X-ray absorptiometry (DEXA). This scan measures the levels of body fat.\n\nOn day 1 of the clinic stay, participants will have 2 set meals, with nothing but water after 10 pm.\n\nOn day 2, they will drink high-fat shakes at 8 am, noon, and 4 pm. They will have blood draws every hour for 17 hours, and then every 2 hours until 7 am. The blood will be taken from a tube inserted into a vein and left in place for the day.\n\nOn day 3, they will go home.",[28],"Lipid Metabolism Disorders",[30,31,32,33,34,35,36,37,38,39],"Vitamin E","Vitamin K","Vitamin D","Vitamin C","Postprandial","Fat meal","Sequestration","Hypertriglyceridemia","Fat-Soluble Vitamins","gamma tocopherol","NOT_YET_RECRUITING","2026-08-20",{"date":43,"type":44},"2026-08-21","ACTUAL",{"date":46,"type":22},"2026-08-26",{"date":48,"type":22},"2029-03-31",{"name":50,"class":51},"National Heart, Lung, and Blood Institute (NHLBI)","NIH",1,{"id":54,"slug":55,"hasResults":12,"nctId":56,"briefTitle":57,"officialTitle":58,"acronym":4,"eligibilityCriteria":59,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":60,"enrollmentInfo":61,"targetDuration":4,"studyType":23,"phases":63,"briefSummary":65,"conditions":66,"keywords":73,"overallStatus":76,"whyStopped":4,"lastUpdateSubmitDate":41,"lastUpdatePostDateStruct":77,"startDateStruct":78,"completionDateStruct":79,"leadSponsor":81,"locationsCount":52},"100641631","fibrotic-disease-activity-in-cardiopulmonary-disorders-using-18f-fibroblast-activation-protein-inhibitor-18f-fapi-74-petct-imaging-100641631","NCT07613099","Fibrotic Disease Activity in Cardiopulmonary Disorders Using 18F-Fibroblast Activation Protein Inhibitor (18F-FAPI-74) PET\u002FCT Imaging","Evaluation of Fibrotic Disease Activity in Cardiopulmonary Disorders Using 18F-Fibroblast Activation Protein Inhibitor (18F-FAPI-74 PET\u002FCT Imaging)","* INCLUSION CRITERIA\n\nIn order to be eligible to participate in this study, an individual must meet all of the following criteria:\n\n1. Provision of signed and dated informed consent form\n2. Stated willingness to comply with all study procedures and availability for the duration of the study\n3. Participant \\>=18 years old\n4. Has a specific diagnosis of a cardiopulmonary and\u002For vascular disease that puts them at risk of developing or having developed tissue fibrosis.\n5. Has undergone prior imaging of lungs, heart, and\u002For vasculature with chest CT\n6. Able to lie on the PET\u002FCT scanner for imaging up to 45 minutes.\n7. For females of reproductive potential: use of highly effective contraception for at least 1 month prior to screening and agreement to use such a method during study participation and for an additional 4 weeks after the end of FAPI-PET\u002FCT or the FDG PET\u002FCT scan.\n8. For males of reproductive potential: use of condoms or other methods to ensure effective contraception with partner during study participation and for an additional 4 weeks after the end of FAPI-PET\u002FCT or the FDG PET\u002FCT scan.\n9. Ability of subject to understand and the willingness to sign a written informed consent document.\n\nEXCLUSION CRITERIA\n\nAn individual who meets any of the following criteria will be excluded from participation in this study:\n\n1. History of allergic reactions attributed to compounds of similar chemical or biologic composition to 18F-FAPI-74 or other agents used in the study.\n2. Uncontrolled intercurrent illness, factors, or social situations that would limit compliance with study requirements\n3. Pregnancy or lactation\n4. Women able to become pregnant or men actively trying to father a child and are unwilling to use an effective form of birth control during the study and 4 weeks after the last 18F-FAPI-74 PET\u002FCT scan or the FDG PET\u002FCT scan.\n5. Subjects with severe claustrophobia unresponsive to oral anxiolytics.\n6. Subjects weighing \\> 350 lbs (weight limit for PET scanner table), or unable to fit within the imaging gantry","100 Years",{"count":62,"type":22},210,[64],"PHASE3","Background:\n\nInjury or diseases of the heart and lung can sometimes cause scar tissue (fibrosis) to build up in those organs. Current imaging scans can see this scar tissue once it has formed, but researchers want to find a way to detect the fibrosis in its earliest stages, while there might still be time to prevent serious damage. A new tracer (a radioactive substance injected during imaging scans) may be able to help.\n\nObjective:\n\nTo test a new tracer (18F-FAPI-74) during imaging scans in people with heart or lung disease.\n\nEligibility:\n\nPeople aged 18 years and older with lung or heart disease that may cause scarring in those organs.\n\nDesign:\n\nParticipants will have 6 clinic visits over 2 years.\n\nParticipants will be screened: They will have blood tests and tests of their heart and lung function. Those with heart disease will have a magnetic resonance imaging (MRI) scan of the heart.\n\nThe study tracer will be used with positron emission tomography (PET)\u002Fcomputed tomography (CT) scans. The study tracer will be injected into a vein in the arm. Participants will lie on a padded bed that slides through a donut-shaped machine.\n\nParticipants will have scans with the study tracer 2 times, 8 to 12 months apart. They will also have standard CT scans and blood tests during these visits. They will also have blood tests at 3 and 6 months between these visits.\n\nParticipants will have a follow-up visit after 18 to 24 months. The study scans, MRI and standard CT scans, and lung function tests may be repeated....",[67,68,69,70,71,72],"Allogeneic Stem Cell Transplantation","Lung Allograft Transplantation","Interstitial Lung Disease","Acute Lung Injury","Pulmonary Arterial Hypertension","Cardiovascular Diseases",[74,75],"Fibroblast activation protein (FAP) FAPI\u002FPET","Fibrotic Disease Activity","RECRUITING",{"date":43,"type":44},{"date":46,"type":22},{"date":80,"type":22},"2033-05-26",{"name":50,"class":51},{"id":83,"slug":84,"hasResults":12,"nctId":85,"briefTitle":86,"officialTitle":86,"acronym":4,"eligibilityCriteria":87,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":60,"enrollmentInfo":88,"targetDuration":4,"studyType":23,"phases":90,"briefSummary":92,"conditions":93,"keywords":96,"overallStatus":76,"whyStopped":4,"lastUpdateSubmitDate":41,"lastUpdatePostDateStruct":99,"startDateStruct":100,"completionDateStruct":102,"leadSponsor":104,"locationsCount":52},"100625905","early-phase-1-immune-profiling-of-cllsll-treated-with-first-line-pirtobrutinib-100625905","NCT07428707","Immune Profiling of CLL\u002FSLL Treated With First-Line Pirtobrutinib","* INCLUSION CRITERIA:\n\nIn order to be eligible to participate in this study, an individual must meet all of the following criteria:\n\n1. Stated willingness to comply with all study procedures\n2. Age \\>=18 years\n3. Confirmed diagnosis of CLL or SLL according to International Workshop on CLL (iwCLL) guidelines\n\n   1. Coexpression of CD5, CD19, CD20, and CD23 expression and light-chain restriction; CD23 dim or negative expression is acceptable as long as other parameters are consistent with a diagnosis of CLL.\n   2. CLL: clonal B-lymphocytosis \\>=5,000 cells\u002FmL\n\n   OR\n\n   SLL: lymphadenopathy with the tissue morphology of CLL but that are not leukemic, \\\u003C5,000 cells\u002FmL\n4. Active disease requiring treatment according to iwCLL guidelines\n5. Measurable disease characterized by \\>=1 of the following:\n\n   1. Lymphadenopathy: \\>=1 lymph node measuring \\>=1.5 cm in the greatest diameter\n   2. Splenomegaly: spleen measuring \\>13 cm in craniocaudal length\n   3. Lymphocytosis: \\>=5,000 B cells\u002FmicroL\n   4. Bone marrow infiltration: CLL comprising \\>= 30% of all cells\n6. Previously untreated CLL with \\>=1 LN amenable to core-needle biopsy\n7. Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.\n8. The patient has adequate organ function for all of the following criteria, as defined below:\n\n   * System: Hepatic\n\n     * Laboratory Value: ALT or AST: \\\u003C= 3 x the ULN or \\\u003C= 5 x ULN with documented liver involvement\n     * Laboratory Value: Total bilirubin: \\\u003C= 1.5 x ULN or \\\u003C= 3 x ULN with documented liver involvement and\u002For Gilbert s Disease\n   * System: Renal\n\n     --Laboratory Value: Serum creatinine: Calculated creatinine clearance \\>= 30 ml\u002Fmin according to Cockcroft\u002FGault Formula: \\[(140-age) x body weight (kg) x 0.85 (if female)\\]\u002F \\[serum creatinine (mg\u002FdL) x 72\\]\n   * System: Hematologic\n\n     * Laboratory Value: Hemoglobin: \\>= 8 g\u002FdL (\\>= 80 g\u002FL)\n     * Laboratory Value: ANC: \\>= 0.75 x 10\\^9\u002FL\n     * Laboratory Value: Platelets: \\>= 50 x 10\\^9\u002FL\n\n   Notes:\n\n   Hgb and platelets: independent of transfusions within 7 days of Screening assessment.\n\n   ANC: independent of growth factor support within 7 days of Screening assessment.\n\n   Criteria must be met on C1D1 without transfusion\u002FG-CSF within 7 days of assessment.\n\n   Abbreviations: ALT = alanine aminotransferase; ANC = absolute neutrophil count; AST =aspartate aminotransferase; ULN = upper limit of normal.\n9. Adequate coagulations, defined as activated partial thromboplastin time (aPTT) or partial thromboplastin time (PTT) and prothrombin (PT) or international normalized ratio (INR) not greater than 1.5 X ULN.\n10. Willingness of WOCBP and their partners to observe highly effective birth control methods for the duration of treatment and for 1 month following the last dose of study treatment.\n11. Ability to take oral medication and be willing to adhere to the study drug regimen\n12. Agreement to adhere to Lifestyle Considerations throughout study duration\n13. Able to understand and willing to sign a written informed consent document.\n\nEXCLUSION CRITERIA:\n\n1. Diagnosis of Richter Transformation\n2. Documented CNS involvement\n3. Pregnancy or plan to become pregnant during the study or within 1 month of the last dose of study treatment. WOCBP must have a negative serum pregnancy test.\n4. Lactation or plan to breastfeed during the study or within 1 week of the last dose of study treatment.\n5. Known active cytomegalovirus (CMV) infections. Unknown or negative status are eligible.\n6. Known active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection based on criteria below:\n\n   1. Patients with positive hepatitis B surface antigen (HBsAg) are excluded.\n   2. Patients with positive hepatitis B core antibody (anti-HBc) and negative HBsAg require a negative hepatitis B polymerase chain reaction (PCR) evaluation before randomization.\n   3. Patients who are HBV DNA PCR positive will be excluded.\n7. Hepatitis C virus (HCV): positive hepatitis C antibody. If positive hepatitis C antibody result, patient will need to have a negative result for hepatitis C ribonucleic acid (RNA) before randomization. Patients who are hepatitis C RNA positive will be excluded.\n8. Patients who have tested positive for Human Immunodeficiency Virus (HIV) and have a detectable viral load and\u002For a CD4 count \\\u003C350 are excluded due to risk of opportunistic infections with both HIV and BTK inhibitors. Eligible patients with HIV must be stable on antiretroviral therapy \\>=4 weeks prior to study entry. For patients with unknown HIV status, HIV testing will be performed at Screening and result must be negative for enrollment.\n9. Clinically significant active malabsorption syndrome or other condition likely to affect gastrointestinal (GI) absorption of the study drug. (e.g., gastric bypass surgery, gastrectomy).\n10. Evidence of other clinically significant uncontrolled condition(s) including but not limited to, uncontrolled systemic bacterial, viral, fungal or parasitic infection (except for fungal nail infection), or other clinically significant active disease process which in the opinion of the investigator and medical monitor may pose a risk for patient participation. Screening for chronic conditions is not required.\n11. Stroke or intracranial hemorrhage within 6 months of screening\n12. Hypertensive urgency or emergency\n13. Active, clinically significant cardiovascular disease including:\n\n    * Unstable angina or acute coronary syndrome within the past 2 months prior to screening\n    * Documentation of LVEF by any method of \\\u003C= 40% in the 12 months prior to screening\n    * Uncontrolled or symptomatic arrhythmias\n    * Class 3 or 4 congestive heart failure as defined by New York Heart Association Functional Classification\n    * Myocardial infarction, unstable angina or acute coronary syndrome within 3 months of screening.\n    * Prolongation of the QT interval corrected for heart rate (QTcF) \\> 470 msec. QTcF is calculated using Fridericia s Formula (QTcF): QTcF=QT\u002F(RR\\^0.33)\n\n    Correction of suspected drug-induced QTcF prolongation can be attempted at the investigator s discretion and only if clinically safe to do so with either discontinuation of the offending drug or switch to another drug not known to be associated with QTcF prolongation.\n\n    \\- Correction for underlying bundle branch block (BBB) allowed.\n\n    Note: Patients with pacemakers are eligible if they have no history of fainting or clinically relevant arrhythmias while using the pacemaker\n14. Known allergy\u002Fsensitivity to pirtobrutinib or any of the excipients (hydroxypropyl methylcellulose acetate succinate, microcrystalline cellulose, mannitol, sodium starch glycolate, and magnesium stearate.).\n15. History of bleeding diathesis (e.g. von Willebrand disease or hemophlia)\n16. Has received a live vaccine or live-attenuated vaccine within 28 days before the first dose of pirtobrutinib. Administration of killed vaccines are allowed.\n17. Patients requiring therapeutic anticoagulation with warfarin or another vitamin K antagonist are excluded. Direct oral anticoagulants (DOACs) are allowed.\n18. Diagnosis of primary immunodeficiency or is receiving chronic systemic steroid therapy (in dosing \\>20 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior the first dose of study medication.\n19. Has active autoimmune disease that has required systemic treatment in the past 2 years except replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid)\n20. Active uncontrolled auto-immune cytopenia (e.g., autoimmune hemolytic anemia \\[AIHA\\], idiopathic thrombocytopenic purpura \\[ITP\\]) for which new therapy was introduced or existing therapy was escalated within the 4 weeks prior to study enrollment to maintain adequate blood counts.\n21. Active second malignancy unless in remission and with life expectancy \\>2 years.\n\n    Note: Participants are eligible if they have prostate cancer under active surveillance or observation.\n22. Has not adequately recovered after 4 weeks from major surgery or has ongoing surgical complications.\n23. Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.\n24. Has a history or current evidence of any condition, therapy, or laboratory abnormality or other circumstance that might confound the results of the study, interfere with the participant s participation for the full duration of the study, such that it is not in the best interest of the participant to participate, in the opinion of the treating investigator.",{"count":89,"type":22},30,[91],"EARLY_PHASE1","Background:\n\nChronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL) are blood cancers that affect certain white blood cells. Advanced forms of these diseases are difficult to treat. Pirtobrutinib is a drug approved to treat CLL and SLL after 2 previous treatments. Researchers want to know how this drug affects the immune system in those who have not yet started other treatments for CLL or SLL.\n\nObjective:\n\nTo test pirtobrutinib as a first-line treatment for CLL or SLL.\n\nEligibility:\n\nPeople aged 18 years and older with untreated CLL or SLL.\n\nDesign:\n\nParticipants will be screened. They will have a physical exam with blood tests. They will have imaging scans and tests of their heart function. They will have a lymph node biopsy: A large needle will be inserted into a lymph node to collect a small piece of tissue.\n\nPirtobrutinib is a tablet taken by mouth. Participants will take 2 to 4 tablets daily in 4-week cycles.\n\nParticipants will have clinic visits once every 4 weeks for the first 3 months. Then they will be seen once every 3 months.\n\nImaging scans, lymph node biopsy, and other tests will be repeated at various study visits.\n\nA bone marrow biopsy (collection of soft tissue from inside a bone) may be done if there is no evidence of disease after 1 year of treatment with the study drug.\n\nParticipants may opt to have cancer and immune cells collected from their blood. The cells will be used for research.\n\nParticipants will have a clinic visit 1 month after their last dose of the study drug. Then they will have follow-up visits or phone calls every 6 to 12 months....",[94,95],"Chronic Lymphocytic Leukemia (CLL)","Small Lymphocytic Lymphoma (SLL)",[97,94,98],"Pirtobrutinib","Immune profiling",{"date":43,"type":44},{"date":101,"type":44},"2026-03-11",{"date":103,"type":22},"2030-03-01",{"name":50,"class":51},{"id":106,"slug":107,"hasResults":12,"nctId":108,"briefTitle":109,"officialTitle":110,"acronym":4,"eligibilityCriteria":111,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":112,"enrollmentInfo":113,"targetDuration":4,"studyType":23,"phases":114,"briefSummary":116,"conditions":117,"keywords":119,"overallStatus":76,"whyStopped":4,"lastUpdateSubmitDate":41,"lastUpdatePostDateStruct":124,"startDateStruct":125,"completionDateStruct":126,"leadSponsor":128,"locationsCount":129},"100588952","syk-inhibition-in-mitigating-lung-allograft-rejection-similar-a-trial-to-evaluate-the-safety-and-tolerability-of-fostamatinib-in-lung-transplant-patients-with-donor-specific-antibodies-100588952","NCT06948097","Syk Inhibition in MItigating Lung Allograft Rejection (SIMILAR): A Trial to Evaluate the Safety and Tolerability of Fostamatinib in Lung Transplant Patients With Donor-Specific Antibodies","Syk Inhibition in MItigating Lung Allograft Rejection (SIMILAR): A Phase 1, Double-Blind, Randomized, Placebo-Controlled, Dose Escalation Trial to Evaluate the Safety and Tolerability of Fostamatinib in Lung Transplant Patients With Donor-Specific Antibodies.","* INCLUSION CRITERIA:\n\nSubjects who do not meet any of the following criteria during screening will not be randomized but will be counted toward study accrual. Screen failures may be rescreened at a later time if the reason for screening failure is revised. In order to be eligible to participate in this study, an individual must meet all of the following criteria:\n\n* First time LT recipients\n* Have provided signed written informed consent, prior to performing any study procedure, including screening procedures.\n* Age greater than or equal to 18 years\n* Patients who are positive for de novo DSA that is first reported on or after day 21 post-transplantation in a recipient with no prior history of the same DSA specificity, and who sign informed consent within 30 days of positive test results.\n* No prior demonstration of DSA specificity at any time point preceding the qualifying positive test (including pre-transplant and post-transplant testing).\n* Demonstrate no clinical or spirometry signs of allograft dysfunction at the time of enrollment.\n* Have adequate liver function, as defined by:\n\n  * Serum aspartate aminotransferase (AST) \\\u003C=1.5 x Upper Limit of Normal (ULN) (unless the increased AST is assessed by the Investigator as due to hemolysis) and alanine aminotransferase (ALT) \\\u003C=1.5 x ULN.\n  * Absolute neutrophil count \\>=1.0 x 10\\^9\u002FL.\n  * Hemoglobin \\>= 9 g\u002FdL\n* For women of reproductive potential, have a negative serum pregnancy test during the screening period. Women of reproductive potential are defined as sexually mature women who have not undergone a hysterectomy, bilateral oophorectomy, or tubal occlusion; or who have not been naturally postmenopausal (i.e., who have not menstruated at all for at least the preceding 1 year prior to signing informed consent unrelated to hormonal contraception).\n* For women of reproductive potential, be abstinent as part of their usual lifestyle, or agree to use 2 effective forms of contraception from the time of giving informed consent, during the study, and for 28 days following the last dose of study treatment. An effective form of contraception is defined as hormonal oral contraceptives, injectables, patches, intrauterine or subdermal contraceptive implants, and barrier methods.\n* Be willing to comply with all study procedures for the duration of the study.\n\nEXCLUSION CRITERIA:\n\nAn individual who meets any of the following criteria will be excluded from participation in this study:\n\n* Have a significant medical condition that confers an unacceptable risk to participating in the study, and\u002For that could confound the interpretation of the study data. Such significant medical conditions include, but are not limited to the following:\n\n  * History of neutropenia (benign ethnic neutropenia and\u002For acquired neutropenia) within 90 days of screening.\n  * History of posterior reversible encephalopathy syndrome (PRES)\n  * History of poorly controlled hypertension or hypertensive crises (defined as systolic blood pressure \\>=180 mmHg or average diastolic blood pressure \\>=120 mmHg based on an average of 3 blood pressure readings despite adequate antihypertensive therapy) unless controlled for \\>90 days prior to enrollment\n  * History of positive post-transplant active hepatitis C and\u002For hepatitis B viral infection.\n  * History of drug-induced cholestatic hepatitis within 90 days of screening.\n  * History of any primary malignancy within the last 5 years, with the exception of: curatively treated non-melanomatous skin cancer; curatively treated cervical or breast carcinoma in situ; or other primary tumor treated with curative intent, no known active disease present, and no treatment administered during the last 5 years.\n  * Testing positive for human immunodeficiency virus 1 or 2 Ab with evidence for ongoing active infection (i.e., CD 4 count \\\u003C400\u002Fmicroliter and viral load \\>100,000 copies\u002Fml) on antiretroviral therapy.\n  * Current or recent history of psychiatric disorder within the last 90 days that, in the opinion of the Investigator or Medical Monitor, could compromise the ability of the subject to cooperate with study visits and procedures.\n  * Are currently enrolled in another therapeutic clinical trial involving ongoing therapy with any investigational or marketed product or placebo.\n  * Having had a prior lung or any organ transplant.\n  * Currently pregnant or lactating.\n  * Estimated glomerular filtration (eGFR) rate less than 30 mL\u002Fmin.\n  * Any grade 3 diarrhea within 90 days of screening.\n* Subjects on strong CYP3A4 inducers. Glucocorticoids are standard transplant therapies and are not excluded. Relevant strong inducers include apalutamide, carbamazepine, encorafenib, enzalutamide, fosphenytoin, lumacaftor, lumacaftor-ivacaftor, mitotane,\n\nphenytoin, rifampin (rifampicin) - (https:\u002F\u002Fwww.uptodate.com\u002Fcontents\u002Fimage?imageKey=CARD%2F76992)\n\n-Subjects who have received prior treatment for DSA within 6 months of screening. Patients on an on-going therapy for first-time DSA are eligible, if screening is performed within 30 days of positive DSA results.","99 Years",{"count":89,"type":22},[115],"PHASE1","Background:\n\nPeople who have lung transplants often survive 6 or 7 years. But some people develop donor-specific antibodies (DSA) after their transplants; antibodies are proteins that attack foreign invaders in the body. Antibodies typically kill viruses and other agents that can cause disease. But when the antibodies attack a transplanted organ, they can cause the body to reject the new tissues. People who develop DSA after a transplant have a higher risk of death within 1 year.\n\nObjective:\n\nTo test a drug called fostamatinib in people who develop DSA after a lung transplant.\n\nEligibility:\n\nAdults aged 18 and older who developed DSA after a lung transplant.\n\nDesign:\n\nParticipants will continue with their standard care after a transplant.\n\nFostamatinib is a pill taken by mouth. Some participants will take the study drug along with their standard care; others will take a placebo. A placebo is a pill that looks just like the real drug but contains no medicine. All participants will take 1 pill per day for 2 weeks. Then they will take 2 pills per day for the next 6 weeks.\n\nParticipants will have clinic visits every 2 weeks while taking their pills. They will have a physical exam, with blood and urine tests, during each visit.\n\nIf participants have fluid samples collected from their airways during their standard treatment, some extra fluid may be collected for this study.\n\nParticipants will have a follow-up visit 4 weeks after they stop taking their pills.",[118],"Lung Transplantation",[120,121,122,123],"Fostamatinib","Lung Transplant","Donor-specific antibodies","Antibody-mediated rejection",{"date":43,"type":44},{"date":46,"type":22},{"date":127,"type":22},"2028-07-14",{"name":50,"class":51},4,{"id":131,"slug":132,"hasResults":12,"nctId":133,"briefTitle":134,"officialTitle":134,"acronym":4,"eligibilityCriteria":135,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":60,"enrollmentInfo":136,"targetDuration":4,"studyType":138,"phases":4,"briefSummary":139,"conditions":140,"keywords":142,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":41,"lastUpdatePostDateStruct":146,"startDateStruct":147,"completionDateStruct":148,"leadSponsor":150,"locationsCount":151},"100467888","nhlbi-emory-advanced-cardiac-ct-reconstruction-100467888","NCT05372627","NHLBI-Emory Advanced Cardiac CT Reconstruction","* INCLUSION CRITERIA:\n\nIn order to be eligible to participate in this study, an individual must meet all of the following criteria:\n\n1. Male or female, aged \\>= 18 years\n2. Undergoing clinically-indicated contrast-enhanced time-resolved cardiac CT for structural heart disease.\n3. Ability of subject to understand and the willingness to sign a written informed consent document.\n\nEXCLUSION CRITERIA:\n\nAn individual who meets any of the following criteria will be excluded from participation in this study:\n\n1. Unable to complete contrast-enhanced cardiac CT acquisition for any reason\n2. Unwilling to authorize future use of their imaging data for research",{"count":137,"type":22},1000,"OBSERVATIONAL","Background:\n\nDoctors use computed tomography (CT) to get detailed pictures of the heart. CT uses x-rays to gather raw data. Computers assemble this data to make the images doctors look at. A new computer technique can make higher resolution images from the same CT scans. In this natural history study, researchers will take normal CT images of the heart. They will compare those images to super high-resolution (super high-res) images made with a super-computer.\n\nObjective:\n\nTo improve the quality of heart CT scans by using new methods to create the images.\n\nEligibility:\n\nPeople aged 18 years or older who need a CT scan for heart disease.\n\nDesign:\n\nParticipants will have a normal CT scan. A substance will be injected through a tube in their arm. They will lie on a table in a large, donut-shaped machine. An X-ray tube will move around their body, taking many pictures.\n\nResearchers will use the normal CT scans to create super high-res images. They may do this at the NIH. They may also send the images to the company that made the CT scanner. Participants personal information will be removed before images are sent to the company. The personal information will be replaced by a code.\n\nThe super high-res images will be returned to the NIH.\n\nSome information will be collected from participants medical records. Researchers will compare the normal scans to the super high-res images.\n\nParticipants' own doctors will also have a chance to see the super high-res images.\n\nParticipants' CT pictures will be stored and used for future NIH research....",[141],"Structural Heart Disease",[143,144,145],"Heart Disease","Image","Natural History",{"date":43,"type":44},{"date":46,"type":22},{"date":149,"type":22},"2031-01-30",{"name":50,"class":51},2,{"id":153,"slug":154,"hasResults":12,"nctId":155,"briefTitle":156,"officialTitle":156,"acronym":4,"eligibilityCriteria":157,"healthyVolunteers":158,"sex":17,"minAge":18,"maxAge":60,"enrollmentInfo":159,"targetDuration":4,"studyType":138,"phases":4,"briefSummary":161,"conditions":162,"keywords":168,"overallStatus":76,"whyStopped":4,"lastUpdateSubmitDate":41,"lastUpdatePostDateStruct":174,"startDateStruct":175,"completionDateStruct":177,"leadSponsor":179,"locationsCount":52},"100444826","natural-history-study-of-cadasil-100444826","NCT05072483","Natural History Study of CADASIL","* INCLUSION CRITERIA:\n\nEligibility for this study may be determined based on information collected under other NHLBI-approved protocols, outside records and patient report.\n\nIn order to be eligible to participate in this study, an individual must meet criteria 1 \\& 2 and either criteria 3 or 4:\n\n1. Stated willingness to comply with all study procedures and availability for the duration of the study.\n2. Male or female, aged 18 to 100 years (inclusive).\n3. Established diagnosis of CADASIL or NOTCH3 mutations, as determined by genetic testing.\n4. Healthy controls.\n\nEXCLUSION CRITERIA:\n\nAn individual who meets any of the following criteria will be excluded from participation in this study:\n\n1. Pregnancy at time of consent.\n2. Subjects who lack capacity to consent and don't have a legally authorized representative.\n3. Subjects who decline to provide samples for blood and\u002For tissue studies.\n4. Subjects who do not speak English.\n5. Subjects whose scans or examinations show unexpected brain conditions (outside of CADASIL) which would interfere with interpretation of testing.\n6. Subjects unable to undergo an MRI scan or subjects meeting the following criteria:\n\n   * Subjects who have internal non-MRI compatible metals (i.e., cardiac pacemaker, brain stimulator, shrapnel, surgical metal, clips in the brain or on blood vessels, cochlear implants, artificial heart valves or metal fragments in the eye) as these rendering an MRI unsafe\n   * Subjects with ferromagnetic dental bridges or crowns (exclusion only for 7.0T)\n   * Subjects unable to remain supine for the expected length of the MRI (i.e., up to 1 hour)\n   * Subjects with uncontrolled head movements\n   * Subjects who are claustrophobic for the expected length of the MRI (i.e., up to 1 hour) and claustrophobia cannot be controlled with anti-anxiety medication.",true,{"count":160,"type":22},155,"Background:\n\nCADASIL (cerebral autosomal dominant arteriopathy with subcortical infarct and leukoencephalopathy) is a genetic disorder. It causes narrowing of the small blood vessels and can lead to strokes and dementia. Researchers want to monitor people with CADASIL over time.\n\nObjective:\n\nTo learn more about how CADASIL affects a person s blood vessels over time.\n\nEligibility:\n\nAdults ages 18 and older who have CADASIL, and healthy volunteers.\n\nDesign:\n\nParticipants will be screened with a medical record review.\n\nParticipants will have 4 study visits over 9 years. Visits will last 6 8 hours per day, for 2 4 days.\n\nParticipants will give blood and urine samples. They will have an electrocardiogram to record their heart s electrical activity. They will fill out a family tree. They will have tests that measure mental abilities like memory and attention. They may have a skin biopsy. They may have a lumbar puncture.\n\nParticipants will have an eye exam. Their pupils will be dilated. They will receive a dye via intravenous (IV) line. Pictures will be taken of their eyes.\n\nParticipants will have an imaging scan of their brain. They may receive a contrast agent via IV.\n\nParticipants blood flow and blood vessel flexibility will be measured. In one test, a probe will be pressed against the skin of the their wrist, neck, and groin. In another test, they will hold one arm still while a microscope makes videos of the blood flow through a fingernail. In another test, they will perform light exercise or other activities while wearing an elastic band around their head or probes placed on their arm or leg.\n\nHealthy volunteers will complete some of the above tests.",[163,164,165,166,167],"Cardiovascular Disease","Arterial Stiffness","Germline Mutation in the NOTCH 3 Gene","Pathogenesis of CADASIL","Clinical Phenotype of CADASIL",[169,170,171,172,173],"Biospecimen Procurement","Laboratory Research Specimens","progressive chronic hypoperfusion","Stroke","progressive white matter degeneration, and debilitating dementia.",{"date":43,"type":44},{"date":176,"type":44},"2022-04-18",{"date":178,"type":22},"2041-06-01",{"name":50,"class":51},{"id":181,"slug":182,"hasResults":12,"nctId":183,"briefTitle":184,"officialTitle":185,"acronym":4,"eligibilityCriteria":186,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":112,"enrollmentInfo":187,"targetDuration":4,"studyType":138,"phases":4,"briefSummary":189,"conditions":190,"keywords":193,"overallStatus":76,"whyStopped":4,"lastUpdateSubmitDate":41,"lastUpdatePostDateStruct":197,"startDateStruct":198,"completionDateStruct":200,"leadSponsor":202,"locationsCount":52},"100370367","chipccus-natural-history-protocol-100370367","NCT04102423","CHIP\u002FCCUS Natural History Protocol","Investigation of the Natural Progression of Clonal Hematopoiesis of Indeterminate Potential and Clonal Cytopenia of Undetermined Significance.","* Participants with Clonal Hematopoiesis of Indeterminate Significance (CHIP):\n\nINCLUSION CRITERIA:\n\n* Greater than or equal to 18 years of age\n* Willingness and capacity to provide written informed consent\n* Presence of a somatic pathogenic variant associated with hematological malignancy\n* Variant allele fraction of greater than or equal to 2% in at least one identified somatic pathogenic variant\n\nEXCLUSION CRITERIA:\n\n* Known diagnosis of a hematological malignancy or bone marrow failure syndrome (excluding MGUS or MBL)\n* Presence of a cytopenia:\n\n  --Hemoglobin, \\\u003C10 g\u002FdL; platelet count, \\\u003C100 X 10\\^9 \u002FL; or absolute neutrophil count, \\\u003C1.5 X 10\\^9 \u002FL\n* Pregnant at the time of recruitment\n\nParticipants with Clonal Cytopenia of Uncertain Significance (CCUS):\n\nINCLUSION CRITERIA:\n\n* Greater than 18 years of age\n* Willingness and capacity to provide written informed consent\n* Presence of a somatic pathogenic variant associated with hematological malignancy without morphological evidence of\n\nmyelodysplasia and without a MDS defining cytogenetic abnormality\n\n* Variant allele fraction of greater than or equal to 2% in at least one identified somatic pathogenic variant\n* Bone marrow aspirate and biopsy excluding hematological malignancy and MDS\n* Presence of a cytopenia for \\>30 days\n\n  * Hemoglobin, \\\u003C10 g\u002FdL; platelet count, \\\u003C100 X10\\^9 \u002FL; or absolute neutrophil count, \\\u003C1.5 X10\\^9 \u002FL\n  * At least 2 CBCs documented in a non-hospitalized patient at least 3 days apart\n\nEXCLUSION CRITERIA:\n\n* Known diagnosis of a hematological malignancy or bone marrow failure syndrome (excluding MGUS or MBL)\n* Morphological evidence of dysplasia on bone marrow aspirate \u002F biopsy 10% dysplastic cells in any hematopoietic lineage\n* Ringed sideroblasts \\>15%\n* Presence of MDS defining cytogenetic abnormality\n\n  * Del(7q)\n  * del(5q)\n  * 17q or t(17p)\n  * Del(13q)\n  * del(11q)\n  * del(12p) or t(12p)\n  * del(9q)\n  * idic(X)(q13)\n  * t(11;16)\n  * t(3;21)\n  * t(1;3)\n  * t(2;11)\n  * inv(3)\u002Ft(3;3)\n* t(6;9)\n\n  --Note: As a sole cytogenetic abnormality in the absence of morphological criteria, gain of chromosome 8, del(20q) and loss of chromosome Y are not considered definitive evidence of MDS.\n* Alternate hematological diagnosis causing cytopenia\n* Pregnant at time of recruitment",{"count":188,"type":22},306,"Background:\n\nClonal Hematopoiesis of Indeterminate Potential (CHIP) is a change in a person s DNA that can increase a person s risk of developing blood cancers or cardiovascular disease. CHIP occurs mostly occurs in older people. Clonal cytopenia of undetermined significance (CCUS) occurs when one or more blood cell types is lower than it should be and is associated with a change in their DNA. Researchers want to learn more about how CHIP and CCUS progress.\n\nObjective:\n\nTo examine the natural history of people in a study of CHIP and CCUS to (1) verify the association of myeloid somatic mutations with atherosclerosis and blood cancers, and (2) find new potential clinical associations.\n\nEligibility:\n\nAdults 18 and older with CHIP with a somatic pathogenic variant associated with blood cancers. Adults with CCUS are also needed.\n\nDesign:\n\nPotential participants will be screened with gene testing. For this, they will give a blood sample. They will also be enrolled in NHLBI screening protocol #97-H-0041. Those who pass this screening will visit the NIH Clinical Center for more screening tests. For this, they will give a blood sample. They will have a physical exam. They will give their medical history. They may give a urine sample. Those with CCUS will have bone marrow taken.\n\nEligible participants will give blood and urine samples. Their heart activity will be monitored and tested. The arteries in their neck will be assessed using ultrasound. They will have liver and heart scans. They will have a bone mineral density scan. They will have lung function tests. They will have the inside of their cheek swabbed or have a skin punch biopsy. They will have the option to have advanced scans done of their heart and full body but this is not required.\n\nParticipants will have yearly follow-up visits for 10 years. They will repeat the above procedures every 1-3 years depending on the procedure.",[191,192],"Clonal Hematopoiesis of Indeterminate Potential","Clonal Cytopenia of Undetermined Significance",[194,195,196,145],"Cytopenia","Myelodysplastic Syndrome","Somatic Mutations",{"date":43,"type":44},{"date":199,"type":44},"2020-03-03",{"date":201,"type":22},"2033-09-15",{"name":50,"class":51},{"id":204,"slug":205,"hasResults":12,"nctId":206,"briefTitle":207,"officialTitle":208,"acronym":4,"eligibilityCriteria":209,"healthyVolunteers":158,"sex":17,"minAge":210,"maxAge":60,"enrollmentInfo":211,"targetDuration":4,"studyType":138,"phases":4,"briefSummary":213,"conditions":214,"keywords":216,"overallStatus":76,"whyStopped":4,"lastUpdateSubmitDate":41,"lastUpdatePostDateStruct":226,"startDateStruct":227,"completionDateStruct":229,"leadSponsor":231,"locationsCount":52},"100330367","technical-and-translational-development-of-cardiovascular-magnetic-resonance-cmr-imaging-100330367","NCT03581318","Technical and Translational Development of Cardiovascular Magnetic Resonance (CMR) Imaging","Technical and Translational Development of Cardiovascular MRI (CMR)","* INCLUSION CRITERIA FOR HEALTHY VOLUNTEERS:\n* Age \\>= 7 years\n* Able to follow instructions and lie still in the MRI scanner\n* Currently without known Cardiovascular disease\n* Able to provide informed consent in writing or provide guardian consent\n* Willingness to cooperate with all study procedures and available for scheduled study events\n\nEXCLUSION CRITERIA FOR HEALTHY VOLUNTEERS:\n\n* Important past or chronic medical illness such as major cardiovascular conditions like myocardial infarction, congenital heart disease, and known cardiomyopathy\n* Conditions that are thought to make MRI unsafe (that will be determined by filling out a separate form) including:\n\n  * Cardiac pacemaker or implantable defibrillator unless it is labeled safe or conditional for MRI\n  * Cerebral aneurysm clip unless it is labeled safe for MRI\n  * Neural stimulator (e.g. TENS-Unit) unless it is labeled safe for MRI\n  * Any type of ear or cochlear implant unless it is labeled safe for MRI\n  * Ocular foreign body (e.g. metal shavings)\n  * Metal shrapnel or bullet unless cleared by plain x-ray as safe for MRI\n  * Any implanted device (e.g. insulin pump, drug infusion device), unless it is labeled safe or conditional for MRI\n* eGFR \\\u003C 60 mL\u002Fmin\u002F1.73m\\^2 using the 2021 CKD-EPI equation or equivalent (using the CRIScalculated eGFR to define the threshold) and a serum creatinine measured within 2 weeks without intercurrent change in medical condition or medications. Subjects meeting this exclusion criterion may still be included in the study but may not be exposed to gadolinium-based contrast agents\n* Pregnancy. When uncertain of pregnancy status, subjects will undergo serum or urine pregnancy testing within the 7 days prior to the examination. Among those subjects who will receive MRI contrast, subjects of child-bearing potential will under serum or urine pregnancy testing within 7 days of the day prior to examination. In addition, the subject will be asked if she may be pregnant prior to the performance of the MRI, even if the pregnancy test was negative within the past week. The pregnancy test will be repeated if she answers in the affirmative. Post-menopausal and surgically sterilized subjects are automatically exempt from this testing.\n* If receiving contrast, breast feeding women (unless subject is willing to discard breast milk for 24 hours) are excluded\n* Healthy volunteer children will not have contrast\n* In a year's time, healthy volunteers are not restricted as to the number of non-contrast MRI examinations they undergo, but they may not undergo more than two examinations involving gadolinium-based contrast agents (GBCA) and those exposures will be at least 18 hours (12 half-lives) apart.\n\nINCLUSION CRITERIA FOR SUBJECTS WITH KNOWN OR SUSPECTED WITH HEART DISEASE:\n\n* Age \\>= 7 years\n* Subjects with known or suspected cardiovascular disease\n* Able to provide informed consent in writing or provide guardian consent\n* Willingness to cooperate with all study procedures (including food restriction) and available for scheduled study events\n\nEXCLUSION CRITERIA FOR SUBJECTS WITH KNOWN OR SUSPECTED HEART DISEASE:\n\n* Conditions that are thought to make MRI unsafe (that will be determined by filling out a separate form) including:\n\n  * Cardiac pacemaker or implantable defibrillator unless it is labeled safe or conditional for MRI\n  * Cerebral aneurysm clip unless it is labeled safe for MRI\n  * Neural stimulator (e.g. TENS-Unit) unless it is labeled safe for MRI\n  * Any type of ear or cochlear implant unless it is labeled safe for MRI\n  * Ocular foreign body (e.g. metal shavings)\n  * Metal shrapnel or bullet unless cleared by plain x-ray as safe for MRI\n  * Any implanted device (e.g. insulin pump, drug infusion device), unless it is labeled safe or conditional for MRI\n* Pregnancy. When uncertain of pregnancy status, subjects will undergo serum or urine pregnancy testing within the 7 days prior to the examination. Among those subjects who will receive MRI contrast, subjects of child-bearing potential will undergo serum or urine pregnancy testing 7 days prior to examination. In addition, the subject will be asked if she may be pregnant prior to the performance of the MRI, even if the pregnancy test was negative within the past week. The pregnancy test will be repeated if she answers in the affirmative. Post-menopausal and surgically sterilized subjects are automatically exempt from this testing.\n* Breast feeding (unless subject is willing to discard breast milk for 24 hours if receiving contrast)\n* eGFR \\\u003C 30 mL\u002Fmin\u002F1.73m\\^2 using the 2021 CKD-EPI equation or Community Practice Standard for Pediatric case or equivalent and a serum creatinine measured within 2 weeks without intercurrent change in medical condition or medications. Subjects meeting this exclusion criterion may still be included in the study but may not be exposed to gadolinium-based contrast agents\n* Cardiorespiratory instability as determined by the enrolling clinician\n\nINCLUSION CRITERIA FOR SUBJECTS WITH NON-CARDIAC DISEASE:\n\n* Age \\>= 7 years\n* Able to provide informed consent in writing or provide guardian consent\n* Willingness to cooperate with all study procedures (including food restriction) and available for scheduled study events\n* Known or suspected brain, hematology, oncology, endocrine, pulmonary, or other non-cardiac disease.\n\nEXCLUSION CRITERIA FOR SUBJECTS WITH NON- CARDIAC DISEASE:\n\n* Conditions that are thought to make MRI unsafe (that will be determined by filling out a separate screening form) including:\n\n  * Cardiac pacemaker or implantable defibrillator unless it is labeled safe or conditional for MRI\n  * Cerebral aneurysm clip unless it is labeled safe for MRI\n  * Neural stimulator (e.g. TENS-Unit) unless it is labeled safe for MRI\n  * Any type of ear or cochlear implant unless it is labeled safe for MRI\n  * Ocular foreign body (e.g. metal shavings)\n  * Metal shrapnel or bullet unless cleared by plain x-ray as safe for MRI\n  * Any implanted device (e.g. insulin pump, drug infusion device), unless it is labeled safe or conditional for MRI\n* Pregnancy. When uncertain of pregnancy status, subjects will undergo serum or urine pregnancy testing within the 7 days prior to the examination. Among those subjects who will receive MRI contrast, subjects of child-bearing potential will undergo serum or urine pregnancy testing on the day of the examination. In addition, the subject will be asked if she may be pregnant prior to the\n\nperformance of the MRI, even if the pregnancy test was negative within the past week. The pregnancy test will be repeated if she answers in the affirmative. Post-menopausal and surgically sterilized subjects are automatically exempt from this testing.\n\n* Breast feeding in those subjects receiving contrast (unless subject is willing to discard breast milk for 24 hours\n* eGFR \\\u003C 30 mL\u002Fmin\u002F1.73m\\^2 using the 2021 CKD-EPI equation or equivalent and a serum creatinine measured within 2 weeks without intercurrent change in medical condition or medications. Subjects meeting this exclusion criterion may still be included in the study but may not be exposed to gadolinium-based contrast agents\n* Cardiorespiratory instability or as determined by the enrolling clinician","7 Years",{"count":212,"type":22},5000,"Background:\n\nMagnetic resonance imaging (MRI) is an important non-invasive tool to study and diagnose cardiovascular disease. MRI scanners use strong magnetic fields and radio waves to create pictures of body organs. Researchers want to find better MRI methods and new ways of imaging cardiovascular disease and better understand normal and abnormal cardiovascular and brain function. Researchers are also interested in seeing if gadolinium, the commonly used MRI contrast agent, stays in the body long after the MRI was performed.\n\nObjectives:\n\nTo develop new methods for imaging the heart and other organs of the body.\n\nTo describe cardiovascular diseases using newer MRI methods\n\nTo look at the relationship between cardiovascular disease and cardiovascular risk factors and other organ systems\n\nTo look for gadolinium deposits in the brain from prior exams.\n\nEligibility:\n\nHealthy people and people with known or suspected cardiovascular disease ages 7 and older may be eligible for this study.\n\nResearchers may be particularly interested in those who:\n\n* Have suspected or known cardiovascular disease\n* Were previously exposed to a gadolinium-based contrast agent,\n* Need to have a heart MRI scheduled\n* Need a test of the heart or other body part or will be undergoing a future cardiac catheterization\n\nDesign:\n\nThere are multiple arms to the study with optional components; therefore, there are multiple variations as to what an individual participant s experience may involve.\n\nParticipants will have an MRI scan lasting up to 2 hours. The scanner is a large hollow tube. During the scan, there may be loud knocking and buzzing sounds caused by the scanner. Participants will lie on a table that slides in and out of the tube. Their vital signs may be monitored.\n\nParticipants may have a test of heart electrical activity using wires connected to pads on the skin.\n\nParticipants may have blood drawn.\n\nParticipants may be injected with an MRI contrast agent through a plastic tube inserted in the arm.",[215],"Normal and Abnormal Cardiovascular Physiology",[217,218,219,220,221,222,223,224,225],"Congenital Heart Defects","Heart Valve Diseases","Chest pain (angina)","Heart Failure","Coronary Heart Disease","CABG","CARDIOMYOPATHY","Atherosclerosis","MRI Technology Improvement",{"date":43,"type":44},{"date":228,"type":44},"2018-07-12",{"date":230,"type":22},"2028-04-01",{"name":50,"class":51},{"id":233,"slug":234,"hasResults":12,"nctId":235,"briefTitle":236,"officialTitle":236,"acronym":4,"eligibilityCriteria":237,"healthyVolunteers":158,"sex":17,"minAge":238,"maxAge":60,"enrollmentInfo":239,"targetDuration":4,"studyType":138,"phases":4,"briefSummary":240,"conditions":241,"keywords":245,"overallStatus":76,"whyStopped":4,"lastUpdateSubmitDate":41,"lastUpdatePostDateStruct":251,"startDateStruct":252,"completionDateStruct":254,"leadSponsor":256,"locationsCount":52},"100327096","vascular-disease-discovery-protocol-100327096","NCT03538639","Vascular Disease Discovery Protocol","* INCLUSION CRITERIA:\n* All subjects must be between the ages of 2-100 years old.\n* Affected pregnant women if they have been referred with a known or suspected pathology or if they become pregnant while on study.\n* Unaffected related pregnant women (including spouses\u002Fpartners) for cord blood and tissue collection (surgical waste) only at the time of delivery.\n\nEXCLUSION CRITERIA:\n\n* Healthy volunteers unable to give informed consent\n* Healthy volunteers who decline to have blood drawn and\u002For tissue studies or who do not consent to have samples stored for future research.\n* Cognitively impaired individuals who are not affected.\n* Cognitively impaired individuals not related to affected subjects.\n* Unaffected unrelated pregnant women.","2 Years",{"count":137,"type":22},"Background:\n\nSome genetic diseases put increase the risk of heart and blood diseases, which are the number one cause of death and disability in the U.S. Researchers want to study diseases of the heart and\u002For blood vessels. They want to collect data and specimens from affected people, their family members, and healthy people.\n\nObjective:\n\nTo study diseases of the heart and\u002For blood vessels.\n\nEligibility:\n\nPeople age 2 and older who may have genetic disease affecting the heart and\u002For blood vessels Their relatives\n\nHealthy volunteers\n\nDesign:\n\nParticipants will be screened with a medical history, physical exams, and imaging tests. Participants may have a few visits or visits for 2 weeks or more. This will depend on their age and disease status. Visits may include:\n\nPhotographs of the face and body\n\nHeart tests\n\nSamples taken of blood, urine, saliva, skin, and\u002For tissue\n\nScans. For some, a dye may be injected into a vein.\n\nA six-minute walk test\n\nLung tests. For some, participants will blow into a tube. For others, they will breathe in a gas from a mask, have a small injection, then have a scan.\n\nStress tests while walking on a treadmill or riding a stationary bike\n\nUltrasound of veins and arteries\n\nDevices outside the body testing the stiffness and function of arteries\n\nEye exam and eye tests. For some, a dye may be injected in a vein.\n\nBlood pressure tests\n\nMeasurements of blood flow under the skin and in the arms and fingernail blood vessels\n\nDevices outside the body testing flexibility of the blood vessels and skin, and skin temperature",[242,243,244],"Vascular Dysfunction","Genetic Mutations","Genetic Predisposition",[246,247,248,249,250,145],"Etiology of Rare and Orphan Diseases with Vascular Phenotype","Natural History of Rare and Orphan Diseases with Vascular Phenotype","Pathophysiology of Uncommon Vascular Diseases","Undiagnosed Diseases","Rare Human Diseases with Vascular Features",{"date":43,"type":44},{"date":253,"type":44},"2018-07-30",{"date":255,"type":22},"2037-05-15",{"name":50,"class":51},{"id":258,"slug":259,"hasResults":12,"nctId":260,"briefTitle":261,"officialTitle":261,"acronym":4,"eligibilityCriteria":262,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":263,"enrollmentInfo":264,"targetDuration":4,"studyType":138,"phases":4,"briefSummary":265,"conditions":266,"keywords":272,"overallStatus":76,"whyStopped":4,"lastUpdateSubmitDate":276,"lastUpdatePostDateStruct":277,"startDateStruct":278,"completionDateStruct":4,"leadSponsor":280,"locationsCount":52},"100127162","natural-history-study-of-monoclonal-b-cell-lymphocytosis-mbl-chronic-lymphocytic-leukemiasmall-lymphocytic-lymphoma-cllsll-lymphoplasmacytic-lymphoma-lplwaldenstrom-macroglobulinemia-wm-and-splenic-marginal-zone-lymphoma-smzl-100127162","NCT00923507","Natural History Study of Monoclonal B Cell Lymphocytosis (MBL), Chronic Lymphocytic Leukemia\u002FSmall Lymphocytic Lymphoma (CLL\u002FSLL), Lymphoplasmacytic Lymphoma (LPL)\u002FWaldenstrom Macroglobulinemia (WM), and Splenic Marginal Zone Lymphoma (SMZL)","-INCLUSION CRITERIA:\n\n1. Diagnosis of CLL\u002FSLL will be made according to the updated criteria of the NCI Working Group.\n\n   * on treatment or previously treated\n   * requiring or nearing first-line treatment\n\n   OR\n\n   Diagnosis of LPL\u002FWM. LPL is defined as the presence of an intertrabecular pattern of bone marrow infiltration by small lymphocytes showing plasmacytoid\u002Fplasma cell differentiation. WM, comprising \\>95% of LPL cases, describes the clinical syndrome of LPL associated with an IgM monoclonal gammopathy of any concentration. The remaining cases may be IgA, IgM, or non-secreting LPL. Immunophenotyping is required for diagnosis\n2. Age greater than or equal to 18 years.\n3. ECOG performance status of 0-2.\n4. Able to comprehend the investigational nature of the protocol and provide informed consent\n\nEXCLUSION CRITERIA:\n\n1\\. None","110 Years",{"count":137,"type":22},"Background\n\nThe development of new technologies now allow scientists to investigate the molecular basis and clinical manifestations of monoclonal B cell lymphocytosis (MBL), chronic lymphocytic leukemia(CLL)\u002Fsmall lymphocytic lymphoma (SLL), lymphoplasmacytic lymphoma (LPL)\u002FWaldenstrom macroglobulinemia (WM), and splenic marginal zone lymphoma (SMZL). Applying these methods in a natural history study can help identify processes involved in disease progression, and possibly lead to the discovery or validation of treatment targets.\n\nObjectives\n\nStudy the history of MBL\u002FCLL\u002FSLL\u002FLPL\u002FWM\u002FSMZL in patients prior to and after treatment. Characterize clinical, biologic and molecular events of disease stability and progression of patients enrolled on this protocol.\n\nEligibility:\n\n* Diagnosis of CLL\u002FSLL and on treatment\u002Fpreviously treated\u002Fnearing treatment\n* Diagnosis of LPL\u002FWM\n* As of February 5, 2025, patients with MBL and SMZL will no longer be enrolled.\n* Age greater than or equal to 18 years.\n* ECOG performance status of 0-2.\n\nDesign\n\nPatients are typically followed every 6 to 24 months in the clinic and have blood drawn. Patients may be asked to undergo additional testing, including bone marrow biopsy and aspiration, lymph node biopsy, positron emission tomography, and CT and MRI scans. Some of these tests (e.g., blood draw) may be required to monitor CLL\u002FSLL and LPL\u002FWM. Other tests (e.g., lymph node biopsy) may not be clinically indicated, but patients may be asked to undergo these procedures for research purposes.\n\nNo treatment will be administered on this study. If a patients requires treatment for their cancer, available NIH clinical trials and alternative treatment options will be discussed with the patient.",[267,268,269,270,271],"Waldenstrom Macroglobulinemia","Lymphoplasmacytic Lymphoma","Monoclonal B-Cell Lymphocytosis","Small Lymphocytic Lymphoma","CLL (Chronic Lymphocytic Leukemia)",[94,273,95,145,274,275],"Monoclonal B Cell Lymphocytosis","Leukemia","Lymphoma","2026-08-19",{"date":41,"type":44},{"date":279,"type":44},"2008-05-29",{"name":50,"class":51},{"id":282,"slug":283,"hasResults":12,"nctId":284,"briefTitle":285,"officialTitle":286,"acronym":4,"eligibilityCriteria":287,"healthyVolunteers":12,"sex":17,"minAge":288,"maxAge":60,"enrollmentInfo":289,"targetDuration":4,"studyType":138,"phases":4,"briefSummary":291,"conditions":292,"keywords":297,"overallStatus":76,"whyStopped":4,"lastUpdateSubmitDate":276,"lastUpdatePostDateStruct":301,"startDateStruct":302,"completionDateStruct":4,"leadSponsor":304,"locationsCount":52},"100054496","study-of-the-disease-process-of-lymphangioleiomyomatosis-100054496","NCT00001465","Study of the Disease Process of Lymphangioleiomyomatosis","Characterization of the Pathogenesis of Lymphangioleiomyomatosis (LAM)","* INCLUSION CRITERIA:\n\nGeneral admission criteria for patients include one or both of the following:\n\nFindings on lung biopsy diagnostic of LAM;\n\nFindings on chest x-ray and\u002For chest computed axial tomography consistent with LAM.\n\nPatients with TSC and pulmonary LAM will be included in the study.\n\nNormal non-smokers in the control group are defined as individuals who have not smoked for greater than or equal to 1 year and have no systemic or pulmonary disease.\n\nNormal smokers defined as individuals with no systemic or pulmonary disease, who have smoked for greater than or equal to 1 year and have normal chest x-ray and normal pulmonary function tests may be included if needed as controls for a similar population of patients with LAM.\n\nPregnant and or nursing women including pregnant minors may be included in accordance with Federal Regulations at Subpart B of 45 CFR 46. Subjects who are pregnant and or nursing will be excluded from procedures during their pregnancy that are greater than minimal risk, until they are no longer pregnant and\u002For nursing. A minor participant with a positive pregnancy test result will be informed promptly. The result will be discussed in a sensitive and developmentally appropriate manner with the minor, including explanation of the result, assessment of safety, and referral for appropriate follow-up care. The participant will be informed of the limits of confidentiality. The study team will encourage involvement of a parent or legal guardian when appropriate and safe. If there is concern for abuse, coercion, exploitation, or danger, the study team will follow applicable mandatory reporting laws and institutional policies, including notification of appropriate authorities and\u002For a parent or guardian when required to protect the participant or as otherwise required.\n\nEXCLUSION CRITERIA:\n\nExclusion criteria for patients include:\n\nAge less than 16.\n\nAdvanced stage of a pulmonary or a systemic illness in which the risk of the study is judged to be significant even in the absence of a clear contraindication to the procedures.\n\nExclusion criteria for patients for the formal exercise study and the stress echocardiogram include patients on continuous oxygen. Patients may perform an exercise test that will assess the patient's exercise capacity with activities of daily living.","16 Years",{"count":290,"type":22},2000,"Pulmonary lymphangioleiomyomatosis (LAM) is a destructive lung disease typically affecting women of childbearing age. Currently, there is no effective therapy for the disease and the prognosis is poor.\n\nThis study is designed to determine the disease processes involved at the level of cells and molecules, in order to develop more effective therapy.\n\nResearchers intend to identify the proteins and genes that contribute to the process of lung destruction in affected individuals.",[293,294,295,296],"Lung Disease","Pneumothorax","Tuberous Sclerosis","Lymphangioleiomyomatosis",[298,299,300,294,295,145],"Smooth Muscle Proliferation","Bronchoscopy","Female",{"date":41,"type":44},{"date":303,"type":44},"1995-12-18",{"name":50,"class":51},{"id":306,"slug":307,"hasResults":12,"nctId":308,"briefTitle":309,"officialTitle":309,"acronym":4,"eligibilityCriteria":310,"healthyVolunteers":158,"sex":17,"minAge":311,"maxAge":60,"enrollmentInfo":312,"targetDuration":4,"studyType":138,"phases":4,"briefSummary":313,"conditions":314,"keywords":316,"overallStatus":76,"whyStopped":4,"lastUpdateSubmitDate":318,"lastUpdatePostDateStruct":319,"startDateStruct":320,"completionDateStruct":322,"leadSponsor":324,"locationsCount":52},"100558565","thrombosis-and-inflammation-in-vessels-initiative-tivi-100558565","NCT06552767","Thrombosis and Inflammation in Vessels Initiative (TIVI)","* INCLUSION CRITERIA:\n\nIn order to be eligible to participate in this study, an individual must meet all of the following criteria:\n\n* Age \\>= 5 years at the time of consent\n* Ability of subject or Legally Authorized Representative (LAR) as applicable to understand and the willingness to sign a written informed consent document\n\nIn addition, the following cohort-specific inclusion criteria apply:\n\nAffected Subjects:\n\n-Known or possible thrombotic, immune, or vascular disorder after review of the subject s medical records and\u002For discussion of medical history\n\nRelatives of Affected Subjects:\n\n-Being a relative of an affected subject\n\nUnrelated Healthy Controls:\n\n-In good general health as evidenced by medical history\n\nEXCLUSION CRITERIA:\n\nAn individual who meets any of the following criteria will be excluded from participation in this study:\n\n-Any condition that in the opinion of the Investigator would warrant exclusion\n\nUnrelated Healthy Controls:\n\n* Unrelated healthy volunteers who decline to have blood drawn and\u002For tissue studies or who do not consent to have samples stored for future research\n* Cognitively impaired individuals","5 Years",{"count":137,"type":22},"Background:\n\nDiseases related to the immune system, blood clots, and blood vessels can affect every part of the body. These diseases are now known to be interrelated: People who have strokes, blood clots in their legs, or autoimmune disease, for example, are at greater risk of complications in the heart, brain, and other organs. Researchers want to learn more about how these diseases start, how they change over time, and how they affect different organs.\n\nObjective:\n\nTo learn more about how inflammation and diseases of the blood vessels start and how they change over time.\n\nEligibility:\n\nPeople aged 5 years and older with a disease related to blood clots, the immune system, or blood vessels. Healthy relatives of people with these diseases and unrelated healthy volunteers are also needed.\n\nDesign:\n\nParticipants will have a baseline visit: They will provide a medical history, physical exam and blood test. All other tests and procedures are optional; these may be spread over more than 1 day:\n\nTests of heart and lung function.\n\nFill in a family tree form.\n\nImaging scans\n\nTreadmill or bike stress tests and a 6-minute walk test.\n\nTests of blood pressure and the flow of blood through vessels.\n\nPhotos of the face and body.\n\nEye exams, with photos taken of the retina.\n\nSaliva and urine samples.\n\nBiopsies (tissues samples) of the skin and fat.\n\nTests of thinking and mental function.\n\nEvaluations by other medical specialists.\n\nParticipants may opt to return for repeat testing for up to 90 months (7.5 years).\n\nSome visits may be done by telehealth.",[72,315],"Vascular Diseases",[317],"Vascular","2026-08-18",{"date":276,"type":44},{"date":321,"type":44},"2024-11-22",{"date":323,"type":22},"2034-01-30",{"name":50,"class":51},{"id":326,"slug":327,"hasResults":12,"nctId":328,"briefTitle":329,"officialTitle":330,"acronym":4,"eligibilityCriteria":331,"healthyVolunteers":158,"sex":332,"minAge":333,"maxAge":334,"enrollmentInfo":335,"targetDuration":4,"studyType":23,"phases":337,"briefSummary":338,"conditions":339,"keywords":341,"overallStatus":76,"whyStopped":4,"lastUpdateSubmitDate":318,"lastUpdatePostDateStruct":345,"startDateStruct":346,"completionDateStruct":348,"leadSponsor":350,"locationsCount":52},"100307894","tailoring-mobile-health-technology-to-reduce-obesity-and-improve-cardiovascular-health-in-resource-limited-neighborhood-environments-100307894","NCT03288207","Tailoring Mobile Health Technology to Reduce Obesity and Improve Cardiovascular Health in Resource-Limited Neighborhood Environments","Tailoring Mobile Health Technology to Reduce Obesity and Improve Cardiovascular Health in Resource-Limited Neighborhood Environments: A Multi-Level, Community-Based Physical Activity Intervention","* INCLUSION CRITERIA:\n\nIndividuals eligible for this protocol are overweight or obese (BMI \\>= 25 kg\u002Fm\\^2) African American women aged 21-75 years who live in Washington, DC Wards 5,7, or 8 and neighboring areas of Prince George s County, MD. Eligible participants should also have access to a smartphone compatible with the mobile app for the protocol that they can use for the study. Eligible participants must be able to provide informed consent independently and also speak and read English at the 8th grade level.\n\nEXCLUSION CRITERIA:\n\n* Medical condition, including heart failure, recent unintentional weight loss or physical limitation, that might prohibit safe participation in physical activity for any reason\n* Heart disease as indicated by history of myocardial infarction in past 1 year, documented obstructive coronary artery disease on coronary angiography, coronary artery stent placement, within the last year significant structural heart disease (e.g. hypertrophic or dilated cardiomyopathy with EF \\\u003C35%, severe valvular heart disease) with evidence of decompensation.\n* Pregnant women due to large hormonal changes during pregnancy that affect study variables and potential pregnancy-related restrictions on exercise. All participants of childbearing potential will need to self-report a negative pregnancy at the screening visit, baseline visit, and at the three-month and six-month visits, unless the participant self-reports being postmenopausal, having had a tubal ligation, or having undergone a complete hysterectomy.\n\nPilot Study INCLUSION CRITERIA:\n\n* Must be an African-American female\n* Must be within the age of 21-75 years old\n* Must be overweight or obese (Body Mass Index (BMI) \\>= 25 kg\u002Fm\\^2)\n* Must live in Washington DC Wards (5, 7, or 8) or live in Prince George s County, Maryland\n* Must have a smartphone that is compatible with the study software (mobile app)\n* Must be willing to use the software on personal smartphone for the study\n* Must be able to provide consent\n* Must be willing to wear the wrist-worn physical activity device for the study\n* Must not be pregnant\n\nOptional MRI Tests\n\nSubjects will be screened for implanted metal objects or devices that may be incompatible with MRI (i.e. cerebral aneurysm clip, cochlear implant, pacemaker, etc.) These subjects will be eligible to proceed with study enrollment, but will not undergo the optional MRI study.","FEMALE","21 Years","75 Years",{"count":336,"type":22},325,[25],"Background:\n\nHeart disease is a leading cause of death. People can reduce their heart disease risk by exercising more. Mobile health technology may make people more successful at increasing their exercise. This includes things like physical activity monitors and smartphone apps.\n\nObjective:\n\nTo find out if mobile health technology can increase physical activity.\n\nEligibility:\n\nAfrican American women ages 21-75 who:\n\n* Are overweight or obese\n* Live in certain areas near Washington, DC\n* Have a smartphone that can use the study app\n\nDesign:\n\nAt visit 1, participants will\n\n* Answer survey questions. These may be about medical history, physical activity, and weight. They may also cover body image, health perception, and spirituality.\n* Have body size measured and get blood tests\n* Get a device to wear on the wrist. It will record physical activity and hours of sleep.\n* Learn how to download and use the study mobile app\n\nFor 2 weeks, researchers will collect data about participants physical activity.\n\nThen participants will have a study visit with additional blood tests.\n\nAll participants will get messages from the app that encourage exercise.\n\nSome participants will get data from the app about exercise near their home or work.\n\nSome participants may get face-to-face coaching.\n\nParticipants may get wireless devices. These measure body weight, blood pressure, and blood glucose. Participants can measure these at home and upload the data to the app for the study.\n\nParticipants will have visits after 3 and 6 months. They will repeat the visit 1 tests.\n\n...",[340],"Obesity",[342,340,343,344],"Community-Based Participatory Research","Cardiovascular Disease Risk","Social Determinants of Health",{"date":276,"type":44},{"date":347,"type":44},"2018-06-21",{"date":349,"type":22},"2027-08-04",{"name":50,"class":51},{"id":352,"slug":353,"hasResults":12,"nctId":354,"briefTitle":355,"officialTitle":355,"acronym":4,"eligibilityCriteria":356,"healthyVolunteers":12,"sex":17,"minAge":357,"maxAge":358,"enrollmentInfo":359,"targetDuration":4,"studyType":138,"phases":4,"briefSummary":361,"conditions":362,"keywords":364,"overallStatus":76,"whyStopped":4,"lastUpdateSubmitDate":318,"lastUpdatePostDateStruct":369,"startDateStruct":370,"completionDateStruct":372,"leadSponsor":374,"locationsCount":375},"100241579","genome-transplant-dynamics-100241579","NCT02423070","Genome Transplant Dynamics","* INCLUSION CRITERIA:\n* Lung and heart transplant candidates. Dual organ transplants such as those that include lung or heart PLUS any other organ are also considered for enrollment.\n* Subjects who have undergone lung or heart transplants and are within 3 months of transplantation.\n* 14 years and older\n* Able to understand and be willing to sign the informed consent form. Subjects undergoing a double transplant will sign a single consent.\n* Retransplant candidates will be considered as a new transplants. These subjects will be approached for enrollment and if they consent to participate, they will be assigned a different SSPIN.\n\nEXCLUSION CRITERIA:\n\n-Pregnancy","14 Years","80 Years",{"count":360,"type":22},991,"Study Description:\n\nHeart and lung transplants can save lives, but long-term success is often limited by organ rejection that is hard to detect early. This study is testing a new, non-invasive blood test that looks for small pieces of DNA from the donor organ in the patient s blood. We believe higher levels of this donor DNA may signal early rejection before damage becomes permanent.\n\nHypothesis:\n\nWe believe that measuring donor-derived DNA in the blood can help detect early signs of rejection and improve outcomes for transplant patients.\n\nThe study also collects genetic and biological samples to explore why some people are more at risk of complications after transplant. This may help guide future research and treatments.\n\nWho Can Join the Study:\n\nPeople receiving a heart or lung transplant (or both), age 14 and older\n\nPeople who are within three months of their transplant\n\nPeople who can understand and agree to take part in the study\n\nParticipants will be asked to provide blood and other samples, and some of these will be used in lab research to explore new ideas about how and why transplant rejection happens.\n\nThis research could lead to better ways to monitor and treat patients after a heart or lung transplant - and help improve long-term survival and quality of life....",[363],"Thoracic Organ Transplantation",[365,366,363,367,368,145],"Cell-free DNA","Acute Rejection","Non-Invasive Testing","Chronic Rejection",{"date":276,"type":44},{"date":371,"type":44},"2015-06-25",{"date":373,"type":22},"2034-11-30",{"name":50,"class":51},6,{"id":377,"slug":378,"hasResults":12,"nctId":379,"briefTitle":380,"officialTitle":381,"acronym":4,"eligibilityCriteria":382,"healthyVolunteers":158,"sex":17,"minAge":383,"maxAge":112,"enrollmentInfo":384,"targetDuration":4,"studyType":138,"phases":4,"briefSummary":385,"conditions":386,"keywords":388,"overallStatus":76,"whyStopped":4,"lastUpdateSubmitDate":318,"lastUpdatePostDateStruct":392,"startDateStruct":393,"completionDateStruct":4,"leadSponsor":395,"locationsCount":52},"100090851","collection-and-analysis-of-blood-bone-marrow-and-buccal-mucosa-samples-from-healthy-volunteers-100090851","NCT00442195","Collection and Analysis of Blood, Bone Marrow, and Buccal Mucosa Samples From Healthy Volunteers","Procurement and Analysis of Blood, Bone Marrow, and Buccal Mucosa Samples From Healthy Volunteers to Support Clinical and Translational Research Projects in the NHLBI","* INCLUSION CRITERIA:\n\nSelf-declared healthy volunteer (for blood and buccal mucosa sample donors).\n\nBe healthy, as determined by Principal Investigator or designee based on recent (\\\u003C3 months) history, physical and laboratory results (for bone marrow and skin tissue sample donors).\n\n\\\u003CTAB\\>\\\u003CTAB\\>\\\u003CTAB\\>\\\u003CTAB\\>\\\u003CTAB\\>\n\nAge 8 years and older (no upper limit) for blood and buccal mucosa sampling.\n\nOR\n\nAges 18 years or older (no upper limit) for bone marrow or skin tissue sampling.\n\nEXCLUSION CRITERIA:\n\nUnable to comprehend the investigational nature of the protocol participation.\n\nCBC determined outside expected normal ranges for the subject (bone marrow and skin tissue donors only).\n\nPregnancy\n\nAge less than 18 years for skin tissue sampling, bone marrow aspirate and biopsy.\n\nOff campus volunteers for skin tissue sampling bone marrow aspirate and biopsy.","8 Years",{"count":137,"type":22},"The Hematology Branch of the National Heart, Lung, and Blood Institute is doing a variety of laboratory research experiments that require blood and tissue samples from healthy volunteers. This protocol provides a mechanism for collecting these tissue samples. Research includes studies of normal and abnormal formation of blood cells, viral blood diseases, the role of the immune system in marrow failure and genetic risk factors for aplastic anemia.\n\nHealthy normal volunteers 8 years of age and older may be eligible for this study. Samples are collected as follows:\n\n* Blood samples: Participants 8 years of age and older donate up to 4 tablespoons of blood, which is obtained from a needle placed in an arm vein.\n* Participants 8 years of age and older donate a buccal mucosa sample (cells from the inside of the cheek). The inside of the cheek is scraped gently with a nylon brush.\n* Participants 18 years of age and older donate a bone marrow sample. The bone marrow is obtained from the hip bone. The skin over the area is wiped clean with alcohol and iodine, and then a local anesthetic is injected under the skin and also into the bone. When the area is numb, a bone marrow aspiration needle is introduced through the bone surface into the marrow. The marrow cells are collected using a syringe connected to the needle.",[387],"Healthy Volunteers",[389,390,391,170,145],"Tissue Procurement","Sample Collection","Biologic Samples",{"date":276,"type":44},{"date":394,"type":44},"2007-03-03",{"name":50,"class":51},{"id":397,"slug":398,"hasResults":12,"nctId":399,"briefTitle":400,"officialTitle":401,"acronym":4,"eligibilityCriteria":402,"healthyVolunteers":158,"sex":17,"minAge":18,"maxAge":112,"enrollmentInfo":403,"targetDuration":4,"studyType":23,"phases":405,"briefSummary":407,"conditions":408,"keywords":409,"overallStatus":76,"whyStopped":4,"lastUpdateSubmitDate":415,"lastUpdatePostDateStruct":416,"startDateStruct":417,"completionDateStruct":419,"leadSponsor":421,"locationsCount":52},"100314378","phase-2-dietary-omega-7-palmitoleic-acid-rich-oil-on-lipoprotein-metabolism-and-satiety-in-adults-100314378","NCT03372733","Dietary Omega-7 Palmitoleic Acid-Rich Oil on Lipoprotein Metabolism and Satiety in Adults","Effect of Dietary Omega-7 Palmitoleic Acid-Rich Oil on Lipoprotein Metabolism and Satiety in Adults","* INCLUSION CRITERIA:\n* Male and female participants 18 years of age or above.\n* Subject must be healthy, with no known history of cardiovascular disease.\n* Post-menopausal or women of childbearing potential must be non-lactating and using an effective form of birth control during the course of the study.\n* Subject understands protocol and provides written, informed consent in addition to a willingness to comply with specified follow-up evaluations.\n* Subjects with triglyceride levels above 100 mg\u002FdL\n\nEXCLUSION CRITERIA:\n\n* Pregnancy, planned pregnancy (within the study period), or women currently breastfeeding.\n* Subjects with allergy or known hypersensitivity to fish, omega-3-acid ethyl esters, omega-7 ethyl esters, other related drugs, or any component of study drugs\n* Subjects with weight changes greater than 20% over the past 3 months.\n* Subjects planning a significant change in diet or exercise levels.\n* Subjects already consuming more than 2 g per day of MUFA, PUFA or other forms of fatty acid supplement if determined by the investigator as having a potential to interfere in the data quality or patient safety.\n* Subjects with chronic diarrhea, gastric bypass or lap-band procedures, ostomies, bowel motility problems, or other known conditions that could affect intestinal fat absorption.\n* Subjects with any acute and life-threatening condition, such but not limited to as prior sudden cardiac arrest, acute myocardial infarction (last three months), stroke, embolism as per investigator assessment.\n* Subjects taking supplements or medications that affect lipoproteins for at least the past 8 weeks, such as fish oil supplements, bile-acid sequestrants, plant sterol supplements, fibrates, statins, Niacin or PCSK9 inhibitors.\n* Subjects being treated with tamoxifen, estrogens, or progestins that have not been stable for \\>4 weeks.\n* Subjects initiating new medications or patients on multiple medications may also be excluded according to investigator discretion.\n* Anticipated surgery during the study period.\n* Liver enzymes (AST or ALT) levels above 3x upper limit of normal.\n* Blood donation in the last 2 weeks or planned blood donation during the study.\n* Subjects requiring regular transfusions for any reason.\n* Subjects may also be excluded for any reason that may compromise their safety or the accuracy of research data or for not complying with protocol directions.\n* Abnormal baseline laboratory values that are considered not clinically significant by the PI will not exclude the subject.",{"count":404,"type":22},110,[406],"PHASE2","Background:\n\nOmega-7 fatty acids are found in the oil extracted from certain fish and nuts like macadamia. Palmitoleic acid is one of the most common omega-7 fatty acids. Many studies suggest that this oil is good for heart health. Researchers want to find out more about these potential benefits.\n\nObjective:\n\nTo study how oil enriched with palmitoleic acid (Omega-7 oil) affects metabolism.\n\nEligibility:\n\nHealthy adults at least 18 years old with no known history of cardiovascular disease.\n\nSubjects not allergic to fish oil and fish products\n\nFemales that are not pregnant and are not planning a pregnancy during the length of the study\n\nDesign:\n\nParticipants will be screened with questions about their health, medical history, and medicines they take.\n\nParticipants will have 4 visits over 24 weeks. The visits may include:\n\n* Blood drawn from a vein in the arm by a needle stick. Sometimes participants will have to fast before the blood draw.\n* Vital signs (blood pressure, heart rate, and temperature) taken\n* Body mass index measured\n* Cardio-Ankle Vascular Index test may be performed. The stiffness of the participant s arteries will be measured by reading blood pressure in the arms and legs and monitoring the heart.\n* Optional stool samples\n* Pregnancy test\n* A short review of participants physical activity and diet\n* A supply of dietary supplements to take between visits. Participants will take 4 gel capsules a day.\n\nParticipants will keep a food and exercise journal\n\nCompensation will be provided to subjects that complete the study\n\nCheck your eligibility for this study by clicking here: https:\u002F\u002Fwww.surveymonkey.com\u002Fr\u002FDietaryOmega\n\n...",[163],[410,411,412,413,414],"Omega-7","Palmitoleic Acid","Monounsaturated Fatty Acids","Lipoproteins","Satiety","2026-08-15",{"date":318,"type":44},{"date":418,"type":44},"2018-07-31",{"date":420,"type":22},"2027-07-31",{"name":50,"class":51},{"id":423,"slug":424,"hasResults":12,"nctId":425,"briefTitle":426,"officialTitle":427,"acronym":4,"eligibilityCriteria":428,"healthyVolunteers":12,"sex":17,"minAge":429,"maxAge":334,"enrollmentInfo":430,"targetDuration":4,"studyType":23,"phases":432,"briefSummary":433,"conditions":434,"keywords":438,"overallStatus":76,"whyStopped":4,"lastUpdateSubmitDate":415,"lastUpdatePostDateStruct":441,"startDateStruct":442,"completionDateStruct":444,"leadSponsor":446,"locationsCount":52},"100299122","phase-1-unrelated-umbilical-cord-blood-transplantation-for-severe-aplastic-anemia-and-hypo-plastic-mds-using-cordintm-umbilical-cord-blood-derived-ex-vivo-expanded-stem-and-progenitor-cells-to-expedite-engraftment-and-improve-transplant-outcome-100299122","NCT03173937","Unrelated Umbilical Cord Blood Transplantation for Severe Aplastic Anemia and Hypo-plastic MDS Using CordIn(TM), Umbilical Cord Blood-Derived Ex Vivo Expanded Stem and Progenitor Cells to Expedite Engraftment and Improve Transplant Outcome","Unrelated Umbilical Cord Blood Transplantation for Severe Aplastic Anemia and Hypo-plastic MDS Using CordIn, Umbilical Cord Blood-Derived Ex Vivo Expanded Stem and Progenitor Cells, to Expedite Engraftment and Improve Transplant Outcome","* INCLUSION CRITERIA - RECIPIENT:\n* Diagnosed with severe aplastic anemia with bone marrow cellularity \\\u003C30% (excluding lymphocytes) associated with RBC or platelet transfusion dependence and\u002For neutropenia (absolute neutrophil count \\\u003C=1000 cells\u002F uL or for patients receiving granulocyte transfusions, absolute neutrophil count \\\u003C=1000 cells\u002F uL before beginning granulocyte transfusions).\n\nOR\n\nHistory of severe aplastic anemia transformed to MDS that meet the following criteria: a) International Prognostic Scoring System (IPSS) risk category of INT-1 or greater, b) \\\u003C 5% myeloblasts and \\\u003C 30% of cellularity in the bone marrow on screening morphologic analysis.\n\n-Intolerance of or failure to respond to immunosuppressive therapy. This also includes patients who have failed immunosuppressive therapy with ATG and cyclosporine or therapy with cyclosporine combined with eltrombopag in those who are intolerant of or do not have access to treatment with ATG.\n\nIdentification of either a) at least one alternative donor (i.e. HLA- haploidentical related donor (i.e. \\>=5\u002F10 HLA match: HLA-A, B, C, DR, and DQ loci) or \\>=9\u002F10 HLA matched unrelated donor) who is available to serve as a stem cell donor for a salvage allogeneic transplant in the event that the CordIn(TM) unit has been rejected or b) umbilical cord blood unit\u002Fs that can be used for a salvage cord blood transplant in the event that the CordIn(TM) unit has been rejected.\n\n-Availability of at least one \\>=4\u002F8 HLA matched (HLA-A, B, C, and DR loci) cord blood unit from the National Marrow Donor Program (NMDP).\n\nThe cord blood unit must contain a minimum TNC of at least 1.8 x 10\\^9 and at least 1.5x10\\^7\u002Fkg TNC and at least 8 x 10\\^6 CD34+ cells (all doses prior to thawing).\n\nException: Cord units containing at least 8 x 10\\^6 CD34+ cells but less than 1.8 x 10\\^9 TNC may be eligible for use on this trial if\n\n1. the pre-expansion CD34\u002Fkg recipient cell number is at least 1.5 x 10\\^5 \u002Fkg\n\n   AND\n2. approval for use of this cord unit for expansion is granted by Gamida Cell.\n3. the final cell counts on the cultured and non-cultured fractions meet the IND specified minimal release criteria.\n\n   * The CBU will have undergone volume reduction (both plasma and red blood cell depletion) prior to cryopreservation. All CBUs should be procured from public banks that meet local applicable regulations.\n   * Ages 4-60 years inclusive.\n   * Ability to comprehend the investigational nature of the study and provide informed consent. The procedure will be explained to subjects aged 4-17 years with formal consent being obtained from parents or legal guardian.\n\nEXCLUSION CRITERIA - RECIPIENT (ANY OF THE FOLLOWING):\n\n* Availability of an HLA identical (12\u002F12) matched related or unrelated donor who is available within optimal timeline and suitable considering graft source and established donor selection factors (e.g. age, sex, viral exposure, ABO compatibility, pregnancy status, etc) per PI discretion.\n* ECOG performance status of 2 or more.\n* Major anticipated illness or organ failure incompatible with survival from transplant.\n* Current pregnancy, or unwillingness to take oral contraceptives or use a barrier method of birth control or practice abstinence to refrain from pregnancy, if of childbearing potential for one year.\n* HIV positive.\n* Diagnosis of Fanconi s anemia (by chromosome breakage study).\n* Diffusion capacity of carbon monoxide (DLCO) \\\u003C40% using DLCO corrected for Hgb or lung volumes (patients under the age of 10 may be excluded from this criterion if they have difficulty performing the test correctly and thus are unable to have their DLCO assessed).\n* Left ventricular ejection fraction \\\u003C 40% (evaluated by ECHO).\n* Transaminases \\> 5x upper limit of normal.\n* Serum bilirubin \\>4 mg\u002Fdl.\n* Creatinine clearance \\\u003C 50 cc\u002Fmin\u002FBSAm2 by 24-hour urine collection adjusted by body surface area.\n* Serum creatinine \\> 2.5 mg\u002Fdl\n* Presence of an active infection not adequately responding to appropriate therapy.\n* History of a malignant disease liable to relapse or progress within 5 years.\n* Allergy to bovine, Gentamicin, or to any product which may interfere with the treatment.\n* Presence of donor-specific antibodies (DSA) to the umbilical cord blood unit and for cohort 1, to the haplo-identical donor.","4 Years",{"count":431,"type":22},37,[115,406],"Background:\n\nSevere aplastic anemia (SAA) and myelodysplastic syndrome (MDS) are bone marrow diseases. People with these diseases usually need a bone marrow transplant. Researchers are testing ways to make stem cell transplant safer and more effective.\n\nObjective:\n\nTo test if treating people with SAA or MDS with a co-infusion of blood stem cells from a family member and cord blood stem cells from an unrelated donor is safe and effective.\n\nEligibility:\n\nRecipients ages 4-60 with SAA or MDS\n\nDonors ages 4-75\n\nDesign:\n\nRecipients will be screened with:\n\n* Blood, lung, and heart tests\n* Bone marrow biopsy\n* CT scan\n\nRecipients will have an IV line placed into a vein in the neck. Starting 11 days before the transplant they will have several chemotherapy infusions and 1 30-minute radiation dose.\n\nRecipients will get the donor cells through the IV line. They will stay in the hospital 3-4 weeks. After discharge, they will have visits:\n\n* First 3-4 months: 1-2 times weekly\n* Then every 6 months for 5 years\n\nDonors will be screened with:\n\n* Physical exam\n* Medical history\n* Blood tests\n\nDonors veins will be checked for suitability for stem cell collection. They may need an IV line to be placed in a thigh vein.\n\nDonors will get Filgrastim or biosimilar (G-CSF) injections daily for 5-7 days. On the last day, they will have apheresis: Blood drawn from one arm or leg runs through a machine and into the other arm or leg. This may be repeated 2 days or 2-4 weeks later.\n\n...",[435,436,437],"Severe Aplastic Anemia","Hypo-Plastic MDS","Myelodysplastic Syndrome (MDS)",[439,440],"Haploidentical","Nonmyeloablative",{"date":318,"type":44},{"date":443,"type":44},"2017-06-13",{"date":445,"type":22},"2032-03-01",{"name":50,"class":51},{"id":448,"slug":449,"hasResults":12,"nctId":450,"briefTitle":451,"officialTitle":452,"acronym":4,"eligibilityCriteria":453,"healthyVolunteers":12,"sex":17,"minAge":429,"maxAge":358,"enrollmentInfo":454,"targetDuration":4,"studyType":23,"phases":456,"briefSummary":457,"conditions":458,"keywords":460,"overallStatus":76,"whyStopped":4,"lastUpdateSubmitDate":415,"lastUpdatePostDateStruct":464,"startDateStruct":465,"completionDateStruct":467,"leadSponsor":469,"locationsCount":151},"100146179","phase-2-allogeneic-hematopoietic-stem-cell-transplantation-for-severe-aplastic-anemia-and-other-bone-marrow-failure-syndromes-using-g-csf-mobilized-cd34-selected-hematopoietic-precursor-cells-co-infused-with-a-reduced-dose-of-non-mobilized-donor-t-cells-100146179","NCT01174108","Allogeneic Hematopoietic Stem Cell Transplantation for Severe Aplastic Anemia and Other Bone Marrow Failure Syndromes Using G-CSF Mobilized CD34+ Selected Hematopoietic Precursor Cells Co-Infused With a Reduced Dose of Non-Mobilized Donor T-cells","Allogeneic Hematopoietic Stem Cell Transplantation for Severe Aplastic Anemia and Other Bone Marrow Failure Syndromes Using G-CSF Mobilized CD34+ Selected Hematopoietic Precursor Cells Co-Infused With a Reduced Dose of Non-Mobilized Donor T-Cells","* INCLUSION CRITERIA:\n* Recipient:\n\n  * Patients diagnosed with one of the following hematologic diseases which are associated with reasonable longevity, shown to be curable by allogeneic BMT but where concern for a high procedural mortality with conventional BMT may delay or prevent such treatment:\n\n    * 1\\) Paroxysmal nocturnal hemoglobinuria (PNH) associated with life-threatening thrombosis, and\u002For cytopenia, and\u002For transfusion dependence and\u002For recurrent and debilitating hemolytic crisis\n    * 2\\) Severe aplastic anemia (SAA) or pure red cell aplasia (PRCA \\[acquired or congenital\\]) with bone marrow cellularity \\\u003C30% (excluding lymphocytes) associated with RBC or platelet transfusion dependence and\u002For neutropenia (absolute neutrophil count \\\u003C=1000 cells\u002FuL or for patients receiving granulocyte transfusions, absolute neutrophil count \\\u003C=1000 cells\u002F uL before beginning granulocyte transfusions). in newly diagnosed patients and\u002For in patients who have failed immunosuppressive therapy.\n    * 3\\) Refractory anemia (RA) or RARS MDS patients who have associated transfusion dependence and\u002For neutropenia.\n  * Ages 4 to 80 (both inclusive), and weight \\>15 kg\n  * Availability of HLA identical or single HLA locus mismatched family donor or 10\u002F10 matched unrelated donor at the allelic level (HLA alleles A, B, C, DR, and DQ).\n  * 9\u002F10 donors where all the HLA sequences have the same antigen\u002Fpeptide binding domains in key exons to the patient. This can result in identical protein sequences between patient and donor. Allele mismatches in p and g groups can be considered acceptable due to the exact matching which exists in the binding domains.\n  * Telomere Length Testing\n  * Germline\u002FInherited gene panel in patients where a suspicion for a familial bone marrow failure syndrome (BMFS) exist, hTERC and hTERT, GATA2 mutation testing will be performed on protocol 04-H-0012 or performed elsewhere prior to enrolling on 04-H-0012.\n\nEXCLUSION CRITERIA:\n\n\\- Recipient: any of the following\n\n* Major anticipated illness or organ failure incompatible with survival from PBSC transplant\n* Diffusion capacity of carbon monoxide (DLCO) \\\u003C40% predicted (patients under the age of 10 may be excluded from this criterion if they have difficulty performing the test correctly and thus are unable to have their DLCO assessed) using DL Adj and DL\u002FVA\u002FAdj.\n* Left ventricular ejection fraction \\\u003C40% (evaluated by ECHO)\n* Serum creatinine greater than 2.5mg\u002Fdl or creatinine clearance less than 50 ml\u002Fmin by 24 hr urine collection\n* Serum bilirubin greater than 4 mg\u002Fdl, transaminases greater than 5 times the upper limit of normal\n* Pregnant or lactating\n* Fanconi s anemia (test to be performed at a CLIA-certified laboratory)\n* ECOG performance status of 3 or more (See NIH Bone \\& Marrow Transplant Consortium Supportive Care Guidelines for HSCT Recipients or Institutional Guidelines for bone and marrow transplants)\n* Other malignant diseases liable to relapse or progress within 5 years, with the exception of a separate hematologic malignancy where allogeneic stem cell transplant has been shown to be potentially curative.\n* Presence of an active infection not adequately responding to appropriate therapy.\n* Inability to comprehend the investigational nature of the study and provide informed consent. The procedure will be explained to subjects age 8 -17 years with formal consent being obtained from parents or legal guardian.\n\nINCLUSION CRITERIA:\n\n-Related Donor:\n\n* Related donor deemed suitable and eligible, and willing to donate, per clinical evaluations who are additionally willing to donate blood samples for research. Related donors will be evaluated in accordance with existing Standard Policies and Procedures for determination of eligibility and suitability for clinical donation. Note that participation in this study is offered to all related donors, but study participation is not required for a donor to make a stem cell donation, so it is possible that not all related donors will enroll onto this study\n* Age greater than or equal to 4 and less than or equal to 80 years old\n\nEXCLUSION CRITERIA:\n\n-Related Donor: None\n\nINCLUSION CRITERIA \\& EXCLUSION CRITERIA: Unrelated Donor\n\n\\- The NMDP unrelated donor inclusion criteria will be used as outlined in document (http:\u002F\u002Fbethematch.org\u002FWorkArea\u002FDownloadAsset.aspx?id=1960). Donor eligibility will be completed per NMDP standards and in accordance with most recent and stringent FDA guidelines.",{"count":455,"type":22},120,[406],"Background:\n\n* Stem cell transplants from related donors (allogenic stem cell transplants) can be used to treat individuals with certain kinds of severe blood diseases or cancers, such as severe anemia. Allogenic stem cell transplants encourage the growth of new bone marrow to replace that of the recipient. Because stem cell transplants can have serious complications, researchers are interested in developing new approaches to stem cell transplants that will reduce the likelihood of these complications.\n* By reducing the number of white blood cells included in the blood taken during the stem cell collection process, and replacing them with a smaller amount of white blood cells collected prior to stem cell donation, the stem cell transplant may be less likely to cause severe complications for the recipient. Researchers are investigating whether altering the stem cell transplant donation procedure in this manner will improve the likelihood of a successful stem cell transplant with fewer complications.\n\nObjectives:\n\n\\- To evaluate a new method of stem cell transplantation that may reduce the possibly of severe side effects or transplant rejection in the recipient.\n\nEligibility:\n\n* Recipient: Individuals between 4 and 80 years of age who have been diagnosed with a blood disease that can be treated with allogenic stem cell transplants.\n* Donor: Individuals between 4 and 80 years of age who are related to the recipient and are eligible to donate blood. OR unrelated donors found through the National Marrow Donor Program.\n\nDesign:\n\n* All participants will be screened with a physical examination and medical history.\n* DONORS:\n* Donors will undergo an initial apheresis procedure to donate white blood cells.\n* After the initial donation, donors will receive injections of filgrastim to release bone marrow cells into the blood.\n* After 5 days of filgrastim injections, donors will have apheresis again to donate stem cells that are present in the blood.\n* RECIPIENTS:\n* Recipients will provide an initial donation of white blood cells to be used for research purposes only.\n* From 7 days before the stem cell transplant, participants will be admitted to the inpatient unit of the National Institutes of Health Clinical Center and will receive regular doses of cyclophosphamide, fludarabine, and anti-thymocyte globulin to suppress their immune system and prepare for the transplant.\n* After the initial chemotherapy, participants will receive the donated white blood cells and stem cells as a single infusion.\n* After the stem cell and white blood cell transplant, participants will have regular doses of cyclosporine and methotrexate to prevent rejection of the donor cells. Participants will have three doses of methotrexate within the week after the transplant, but will continue to take cyclosporine for up to 4 months after the transplant.\n* Participants will remain in inpatient care for up to 1 month after the transplant, and will be followed with regular visits for up to 3 years with periodic visits thereafter to evaluate the success of the transplant and any side effects.",[435,459],"MDS (Myelodysplastic Syndrome)",[437,435,461,462,463],"Pure Red Cell Aplasia","Paroxysmal Nocturnal Hemoglobinuria (PNH)","Miltenyi CD34 Reagent System",{"date":318,"type":44},{"date":466,"type":44},"2010-12-10",{"date":468,"type":22},"2028-06-30",{"name":50,"class":51},{"id":471,"slug":472,"hasResults":12,"nctId":473,"briefTitle":474,"officialTitle":475,"acronym":4,"eligibilityCriteria":476,"healthyVolunteers":12,"sex":17,"minAge":238,"maxAge":60,"enrollmentInfo":477,"targetDuration":4,"studyType":138,"phases":4,"briefSummary":478,"conditions":479,"keywords":481,"overallStatus":76,"whyStopped":4,"lastUpdateSubmitDate":415,"lastUpdatePostDateStruct":487,"startDateStruct":488,"completionDateStruct":4,"leadSponsor":490,"locationsCount":52},"100084203","causes-and-natural-history-of-dyslipidemias-100084203","NCT00353782","Causes and Natural History of Dyslipidemias","Disease Pathogenesis and Natural History of Lipid Disorders","* INCLUSION CRITERIA:\n* Children \\>= 2 years of age and \\>12 kg and adults\n* Dyslipidemia subjects of interest the group\n\nThe following is a representative list of the types of patient presentations with dyslipidemia and potential diagnoses eligible for this protocol:\n\n* Plasma cholesterol levels \\>200 mg\u002Fdl or \\\u003C120 mg\u002Fdl includes patients with diagnoses such as familial hypercholesterolemia, familial combined hyperlipidemia, sitosterolemia, lipoprotein lipase, hepatic lipase or apo-CII deficiency, and dysbetalipoproteinemia.\n* Plasma LDL-C levels \\>130 mg\u002Fdl or \\\u003C70 mg\u002Fdl includes patients with diagnoses such as familial hypercholesterolemia, PCSK9, apo3500, familial combined hyperlipidemia, sitosterolemia, dysbetalipoproteinemia, abetalipoproteinemia and hypobetalipoproteinemia.\n* Plasma HDL-C levels \\>70 mg\u002Fdl or \\\u003C25 mg\u002Fdl includes patients with deficiency of cholesteryl ester transfer protein, lecithin cholesterol acyltransferase, phospholipid transfer protein, lipoprotein lipase, hepatic lipase, or apo-CII, ANGPTL3, and Tangier disease.\n* Plasma triglyceride levels \\>150 mg\u002Fdl includes patients with deficiency of lipoprotein lipase, hepatic lipase or apoC-II, GPIHBP1, LMF1, dysbetalipoproteinemia, Type I, Type IV and Type V hyperlipidemia.",{"count":290,"type":22},"This study will evaluate people with dyslipidemias - disorders that affect the fat content in the blood. Fats, or lipids, such as cholesterol and triglycerides, are carried in the blood in particles called lipoproteins. These particles are involved in causing blood vessel diseases that can lead to conditions like atherosclerosis (hardening of the arteries) or heart attack. Participants will undergo accepted medical tests and procedures to evaluate their condition. Most of the test results are helpful in making a diagnosis and in guiding treatment.\n\nPeople with lipid disorders are eligible for this study. Representative types of patients include those with:\n\n* Plasma cholesterol levels greater than 200 mg\u002Fdl or less than 120 mg\u002Fdl\n* Plasma LDL-C levels greater than 130 mg\u002Fdl or less than 70 mg\u002Fdl\n* Plasma HDL-C levels greater than 70 mg\u002Fdl or less than 25 mg\u002Fdl\n* Unusual cholesterol deposits or xanthomas (nodules of lipid deposits on the skin)\n\nChildren under 2 years of age are excluded from the study.\n\nParticipants will undergo some or all of the following procedures:\n\n\\- Plasma evaluation. Apolipoproteins (plasma proteins involved in metabolism of cholesterol, triglycerides, phospholipids, and proteins in the blood) and enzymes involved in lipid metabolism are measured.",[480,224],"Hypercholesterolemia",[482,483,484,485,486,145],"Triglyceride","Phospholipids","Free and Esterfied Cholesterol","Polydisperse","Lipoprotein Transport System",{"date":318,"type":44},{"date":489,"type":44},"2003-10-14",{"name":50,"class":51},{"id":492,"slug":493,"hasResults":12,"nctId":494,"briefTitle":495,"officialTitle":496,"acronym":4,"eligibilityCriteria":497,"healthyVolunteers":12,"sex":17,"minAge":238,"maxAge":498,"enrollmentInfo":499,"targetDuration":4,"studyType":138,"phases":4,"briefSummary":501,"conditions":502,"keywords":504,"overallStatus":76,"whyStopped":4,"lastUpdateSubmitDate":415,"lastUpdatePostDateStruct":510,"startDateStruct":511,"completionDateStruct":4,"leadSponsor":513,"locationsCount":514},"100063917","natural-history-of-sickle-cell-disease-100063917","NCT00081523","Natural History of Sickle Cell Disease","Studies of the Natural History of Sickle Cell Disease","* INCLUSION CRITERIA:\n* Individuals with known or suspected sickle cell disease\n* 2 years of age and older\n* Willing to provide informed consent or appropriate informed consent from parent or legal guardian\n* Patients seen at sickle outpatient clinics at any one of the participating centers (CNHS or NIH).\n\nEXCLUSION CRITERIA:\n\n* Patient and\u002For guardian unable and unwilling to give informed consent or assent.\n* Patients less than 2 years of age.\n\nIndividuals with known or suspected sickle cell disease will meet the inclusion criteria to enroll in this protocol and can undergo study activities. However, if the individual is found not to have sickle cell disease after enrollment, they will be removed from the protocol, and their research samples will be discarded but they will be counted toward the study accrual. The study team will notify the individual about their removal from the study and explain the reason for it. Any necessary regulatory reporting will also be completed.","90 Years",{"count":500,"type":22},3500,"This study is not a treatment protocol and no experimental treatments are involved. Study participants may be seen as needed for clinical, translational and basic research studies, or as medically indicated. Subjects will receive their general medical care outside the NIH and will be seen at our clinic or at CNHS with varying frequency. Subjects may be seen for multiple visits. Subjects may be asked to return for additional testing as needed. Clinical care for patients with sickle cell disease will be provided as appropriate through the Sickle Cell Clinic and the inpatient clinical center.",[503],"Pain Crisis",[505,506,507,508,509,145],"Hemoglobin","Acute Chest Syndrome","Treatment Options","Nitric Oxide","Pulmonary Hypertension",{"date":318,"type":44},{"date":512,"type":44},"2004-04-29",{"name":50,"class":51},3,{"id":516,"slug":517,"hasResults":12,"nctId":518,"briefTitle":519,"officialTitle":520,"acronym":4,"eligibilityCriteria":521,"healthyVolunteers":158,"sex":332,"minAge":522,"maxAge":523,"enrollmentInfo":524,"targetDuration":4,"studyType":138,"phases":4,"briefSummary":526,"conditions":527,"keywords":529,"overallStatus":76,"whyStopped":4,"lastUpdateSubmitDate":533,"lastUpdatePostDateStruct":534,"startDateStruct":536,"completionDateStruct":538,"leadSponsor":540,"locationsCount":52},"100363602","geospatial-analysis-of-neighborhood-environmental-stress-in-relation-to-biological-markers-of-cardiovascular-health-and-health-behaviors-in-women-100363602","NCT04014348","Geospatial Analysis of Neighborhood Environmental Stress in Relation to Biological Markers of Cardiovascular Health and Health Behaviors in Women","Pilot Study for Geospatial Analysis of Neighborhood Environmental Stress in Relation to Biological Markers of Cardiovascular Health and Health Behaviors in Women","* INCLUSION CRITERIA:\n\nIndividuals eligible for this protocol:\n\n1. A healthy self-identified White female (i.e. self-identifies as White or of European descent) or healthy Black female (i.e. self-identifies as Black, African American, or of African descent)\n2. Must be between 19 to 45 years of age\n3. Must not have any chronic health condition (i.e.: cardiovascular, autoimmune, endocrinologic), or active infection\n4. Must be living in Washington, DC\n5. Must have access to a smartphone\n6. Must be able to provide informed consent\n7. Must speak English.\n\nEXCLUSION CRITERIA:\n\n1. Pregnant or breast feeding\n2. Physically unable to perform physical activity for any reason\n3. Subject had weight changes greater than 20% over the past 3 months\n4. Subject is obese by our measurements (BMI greater than or equal to 35.0 kg\u002Fm\\^2)\n5. If you have high or low blood pressure requiring medications\n6. Diabetes\n7. History of severe mental illnesses, treated with hospitalization\n8. If you have evidence of active thyroid disease requiring medications\n9. If you are taking medication for chronic non-mental health related illness (ie: cardiovascular, autoimmune, endocrinologic)\n10. If you have food allergies or highly restrictive diets that may prevent your ability to consume a controlled metabolic diet.\n11. If you are a current smoker (tobacco products)","19 Years","45 Years",{"count":525,"type":22},250,"Background:\n\nHeart disease is a leading cause of death in the United States. Healthy diet and exercise improve heart health. Some features of where a person lives can lead to stress and decrease chances for exercise. Researchers want to see how these factors may increase the risk of heart disease in women.\n\nObjective:\n\nTo see if there are differences in stress levels between women who live in different parts of Washington, DC. Also, to see how these women use their neighborhoods for exercise.\n\nEligibility:\n\nHealthy white or black females ages 19-45 who live in Washington, DC, who have access to a smartphone\n\nDesign:\n\nParticipants may stay at the NIH Clinical Center overnight for a 2-day visit.\n\nVisit 1 will include:\n\nPhysical exam\n\nBlood tests\n\nElectrocardiogram: Electrodes on the participant s skin will measure heart activity.\n\nPET\u002FCT scan: Participants will get an injection. They will lie in a machine that takes pictures of the body.\n\nSurveys\n\nBody size measurements\n\nNutrition consultation\n\nBlood vessel tests: This is measured with blood pressure cuffs, a device placed on the participant s fingertip, and a probe placed on the participant s neck.\n\nResting Energy Expenditure: Participants will breathe under a clear hood for 45 minutes.\n\nParticipants will be followed for about 2 weeks. They will wear a device on the wrist and carry a GPS device. Through a mobile app, they will answer short daily surveys on stress and exercise.\n\nVisit 2-\n\nDevice return\n\nNutritional consultation",[528],"Cardiovascular (CV) Risk",[530,343,344,531,532,145],"Neighborhood Environment","Diagnostic Behavioral study","Socio-Economic","2026-08-14",{"date":535,"type":44},"2026-08-17",{"date":537,"type":44},"2021-10-20",{"date":539,"type":22},"2026-12-26",{"name":50,"class":51},{"id":542,"slug":543,"hasResults":12,"nctId":544,"briefTitle":545,"officialTitle":546,"acronym":4,"eligibilityCriteria":547,"healthyVolunteers":158,"sex":17,"minAge":18,"maxAge":358,"enrollmentInfo":548,"targetDuration":4,"studyType":138,"phases":4,"briefSummary":550,"conditions":551,"keywords":555,"overallStatus":76,"whyStopped":4,"lastUpdateSubmitDate":533,"lastUpdatePostDateStruct":560,"startDateStruct":561,"completionDateStruct":563,"leadSponsor":565,"locationsCount":52},"100338382","genotype--phenotype-correlation-of-pklr-variants-with-pyruvate-kinase-23-diphosphglycerate-and-adenosine-triphosphate-activities-in-red-blood-cells-of-people-with-sickle-cell-disease-100338382","NCT03685721","Genotype -Phenotype Correlation of PKLR Variants With Pyruvate Kinase, 2,3-Diphosphglycerate and Adenosine Triphosphate Activities in Red Blood Cells of People With Sickle Cell Disease","Genotype -Phenotype Correlation of PKLR Variants With Pyruvate Kinase, 2,3-Diphosphglycerate and ATP Activities in Red Blood Cells of Patients With Sickle Cell Disease","* INCLUSUION CRITERIA:\n* Between 18 and 80 years of age\n* African or of African descent\n* Capacity to consent is required\n\nEXCLUSION CRITERIA:\n\n* Self-reported history of blood transfusion within the last 8 weeks\n* Known to have pyruvate kinase deficiency and be on AG348\n* All volunteers will undergo the consent process under this protocol to allow for eligibility assessment. Once they have been consented to participate, they will undergo procedures per Protocol.",{"count":549,"type":22},800,"Background:\n\nSome people with the same disorder on a genetic level have more complications than others. Researchers want to look for a link between the PKLR gene and sickle cell disease (SCD) symptoms. The PKLR gene helps create a protein, called pyruvate kinase that is essential in normal functioning of the red blood cell. Differences in the PKLR gene, called genetic variants, may cause some changes in the pyruvate kinase protein and other proteins, that can affect functioning of the red blood cell adding to the effect of SCD. Researchers can study these differences by looking at DNA (the material that determines inherited characteristics).\n\nObjective:\n\nTo study how the PKLR gene affects sickle cell disease.\n\nEligibility:\n\nAdults ages 18-80 of African descent. They may have sickle cell disease or not. They must not have had a transfusion recently or have a known deficiency of pyruvate kinase. They cannot be pregnant.\n\nDesign:\n\nParticipants will be screened with questions.\n\nParticipants will have blood drawn by needle in an arm vein. The blood will be genetically tested. Not much is known about how genes affect SCD, so the test results will not be shared with participants or their doctors.\n\n...",[552,553,554],"Sickle Cell","PKLR Variants","Adenosine Triphosphate Activities",[556,557,558,559,145],"ATP","Trait","GDP","Genetics",{"date":535,"type":44},{"date":562,"type":44},"2018-10-11",{"date":564,"type":22},"2027-07-01",{"name":50,"class":51},{"id":567,"slug":568,"hasResults":12,"nctId":569,"briefTitle":570,"officialTitle":570,"acronym":4,"eligibilityCriteria":571,"healthyVolunteers":158,"sex":17,"minAge":18,"maxAge":60,"enrollmentInfo":572,"targetDuration":4,"studyType":23,"phases":574,"briefSummary":575,"conditions":576,"keywords":578,"overallStatus":76,"whyStopped":4,"lastUpdateSubmitDate":533,"lastUpdatePostDateStruct":584,"startDateStruct":585,"completionDateStruct":587,"leadSponsor":589,"locationsCount":52},"100311207","technical-development-of-cardiovascular-magnetic-resonance-imaging-cmr-using-a-low-specific-absorption-rate-sar-scanner-system-100311207","NCT03331380","Technical Development of Cardiovascular Magnetic Resonance Imaging (CMR) Using a Low Specific Absorption Rate (SAR) Scanner System","* INCLUSION CRITERIA:\n\nInclusion Criteria for All Participants (Objectives 1, 2, 3, and 4)\n\n* Men and women age greater than or equal to 18 years\n* Able to provide informed consent in writing\n* Willingness to cooperate with all study procedures (including food restriction) and available for scheduled study events\n\nInclusion Criteria for Healthy Volunteers (Objectives 1 and 2)\n\n-Currently healthy, self-reported\n\nInclusion Criteria for Subjects with Heart Disease (Objective 3)\n\n* Subjects having known heart disease including but not limited to\n* Stable angina pectoris due to epicardial coronary artery obstruction\n* Past myocardial infarction\n* Heart failure with reduced ejection fraction\n* Valvular heart disease\n* Pulmonary artery hypertension\n* Congenital heart disease with or without prior repair\n* Myocarditis\n* Infiltrative cardiomyopathy\n* Hypertrophic cardiomyopathy\n\nInclusion Criteria for Subjects with Non-Cardiac Disease (Objective 4)\n\n* Having known brain disease including but not limited to:\n\n  * Transient ischemic attack or stroke after 24 hours of onset\n  * Infection, inflammation meningitis\n  * Cognitive decline, neurodegenerative disorders\n  * Demyelinating disease, multiple sclerosis\n  * Loss of consciousness, seizures, epilepsy\n  * Brain tumor, metastases, abscess, lesion\n  * Vascular pathology\n  * Headache\n  * Hemorrhage\n  * Trauma\n* Have known musculoskeletal disease including but not limited to:\n\n  * Persistent neck pain or radiculopathy\n  * Cancer or tumors of the spine\n  * Congenital abnormalities of the spinal cord or knee\n  * Multiple sclerosis\n  * Injury or trauma\n  * Fracture evaluation\n  * Infectious or inflammatory processes\n  * Soft tissue damage\n  * Muscle or tendon disorders\n  * Knee meniscal disorders\n  * Marrow abnormalities\n  * Mechanical knee symptoms\n  * Vascular conditions\n* Have known abdominal diseases including but not limited to:\n\n  * Bowel obstruction\n  * Masses and tumors\n  * Crohns disease\n  * Diffuse liver disease such as hemochromatosis, hemosiderosis, fatty infiltration\n  * Focal hepatic lesions\n  * Cirrhotic liver\n  * Iron content determination\n  * Cystic kidney disease\n  * Vascular abnormalities\n* Have known lung disease including but not limited to:\n\n  * Cancer, tumors and masses\n  * Vascular and lymphatic abnormalities\n  * Pulmonary thromboembolic disease\n  * Trauma\n  * Suspected bronchiolitis\n  * Bronchiectasis or pneumonitis\n  * Asthma and other obstructive lung diseases\n  * Pulmonary lymphangioleiomyomatosis\n  * Cystic and interstitial lung diseases such as pulmonary lymphangioleiomyomatosis and cystic fibrosis\n* Have other known non-cardiovascular disease\n\nInclusion criteria for bronchodilators:\n\n\\- Only subjects who use bronchodilators routinely or those have undergone previous pulmonary function testing with bronchodilators will be invited to undergo bronchodilator testing during MRI.\n\nEXCLUSION CRITERIA:\n\nExclusion Criteria for All Participants:\n\n* Conditions that are thought to make MRI unsafe (that will be determined by filling out a separate form) including:\n\n  * Cerebral aneurysm clip unless it is labeled safe for MRI\n  * Neural stimulator (e.g. TENS-Unit) unless it is labeled safe for MRI\n  * Any type of ear implant unless it is labeled safe for MRI\n  * Ocular foreign body (e.g. metal shavings)\n  * Metal shrapnel or bullet\n  * Any implanted device (e.g. insulin pump, drug infusion device), unless it is labeled safe for MRI\n* Pregnancy. When uncertain, subjects will undergo either urine or serum pregnancy testing. Results from up to 3 days prior to the examination will be used. Post-menopausal and surgically sterilized subjects are exempt from this testing.\n\n  * If a urine or serum pregnancy test was administered as part of a referral protocol, and the test was administered up to 3 days prior to MRI examination for this protocol, a new pregnancy test will not be required for this protocol.\n  * If a pregnancy test has not been administered within 3 days of MRI examination for this protocol, a serum or urine pregnancy test will be administered. Medical personnel will determine which pregnancy test is appropriate based on subject s medical history, screening, and individual scenario. In addition, the subject will be asked if she may be pregnant prior to the performance of the MRI, even if the pregnancy test was negative within the past week. The pregnancy test will be repeated if she answers in the affirmative.\n\nExclusion Criteria for Gadolinium:\n\n-When gadolinium based contrast agent (GBCA) exposure is planned\n\n* Objective 1 and 2, Healthy Volunteers: No gadolinium based contrast agent exposure is permitted if eGFR \\\u003C 60 mL\u002Fmin\u002F1.73m\\^(2) using the CKD-EPI equation or equivalent and a serum creatinine measured within 2 weeks without intercurrent change in medical condition or medications.\n* Objective 3 and 4, Volunteers with Cardiac and Non-Cardiac Disease: No gadolinium based contrast agent exposure is permitted if eGFR \\\u003C 30 mL\u002Fmin\u002F1.73m\\^(2) using the CKDEPI equation \\[25\\] or equivalent and a serum creatinine measured within 2 weeks without\n\nintercurrent change in medical condition or medications.\n\n--For all objectives not more than two research MRI exams with GBCA exposure in a 12 month period. Research MRI exams performed outside of this protocol will be included in the 12 month period.\n\n* Subjects meeting this exclusion criterion, or without eGFR determination, may still be included in the study but may not be exposed to gadolinium-based contrast agents\n* Breast feeding (unless subject is willing to discard breast milk for 24 hours)\n* Does not wish to be exposed to gadolinium.\n\nExclusion Criteria for Oxygen Inhalation:\n\n* Severe chronic obstructive pulmonary disease defined as requiring more than one bronchodilator medication every day or continuous oxygen requiring\n* Prior treatment with bleomycin\n\nExclusion Criteria for Ferumoxytol Contrast\n\n* A history of allergic reaction to any intravenous iron product\n* Allergy to ferumoxytol or to mannitol excipient\n* Breast feeding\n* Does not wish to be exposed to ferumoxytol\n* Iron overload\n\nExclusion Criteria for oral contrast agent:\n\n* A history of reaction to oral contrast (if using barium sulfate)\n* Breast feeding unless subject is willing to discard breast milk for 24 hours (if using barium sulfate)\n* Allergy to pineapple (if using pineapple juice)\n* Does not wish to be exposed to oral contrast\n\nExclusion Criteria for Healthy Volunteers (Objectives 1 and 2)\n\n-Important past medical illness\n\nExclusion Criteria for Adults with heart Disease (Objective 3)\n\n* Unstable angina, acute coronary syndrome, or myocardial infarction not attributable to PCI, within 2 weeks unless after coronary revascularization of the culprit lesion.\n* Any hemodynamic instability or decompensated heart failure as determined by the enrolling physician.\n* Adenosine: Patients with asthma or chronic obstructive pulmonary disease of any severity are ineligible for vasodilator stress CMR with adenosine.\n* Regadenoson: Only patients with severe or uncontrolled asthma or severe or uncontrolled chronic obstructive pulmonary disease are ineligible for vasodilator stress CMR with regadenoson. This will be determined at the discretion of the supervising provider based on medical records and physical exam.\n* Patients with advanced heart block on baseline ECG are ineligible for vasodilator stress CMR\n\nExclusion Criteria for Adults with Non-Cardiac Disease (Objective 4)\n\n* Acute illness for which investigational imaging might delay care (such as acute stroke before treatment), as determined by the enrolling physician\n* Any hemodynamic instability as determined by the enrolling physician.\n\nExclusion criteria for bronchodilators:\n\n\\- Patient refuses bronchodilator administration.\n\nExclusion criteria for adults with cardiac implanted electronic devices (CIED, pacemakers or defibrillators:\n\nLow-SAR MRI:\n\n* Subjects with MRI-conditional and legacy CIEDs are not excluded, based on the intrinsic safety of low-SAR MRI.\n* Subjects with CIEDs are excluded if they have pacemakers implanted before 1998; ICDs implanted before 2000; temporary, epicardial or abandoned leads; and CIEDs implanted \\\u003C4 weeks prior to MRI exam.\n\nConventional MRI:\n\n-Subjects with CIED are excluded from conventional MRI unless they have CIEDs that are labeled as MRI conditional or MRI safe, and that are implanted greater than or equal to 4 weeks prior to MRI.",{"count":573,"type":22},2950,[25],"Background:\n\nResearchers are testing version of a system known as a magnetic resonance imagining (MRI) scanner that uses strong magnetic fields, radio waves and the like to create images of the organs in the body. It uses lower energy levels than other MRI scanners. This may help scan people with metal devices in their body, or in invasive heart procedures using metal tools.\n\nObjective:\n\nTo test a new MRI scanner and software changes to create better pictures.\n\nEligibility:\n\nPeople with disease and healthy volunteers, ages 18 and older.\n\nDesign:\n\nParticipants will be screened with blood tests.\n\nParticipants may have both the new MRI and a conventional MRI or only the new one. If 2 are done, they must be within 60 days.\n\nFor both MRI versions, participants lie on a table that slides into a large tube. During scans, they will hold their breath for up to 20 seconds at a time. Heart activity will be measured by wires connected to pads on the skin. A flexible belt may be used to monitor their breathing. They will be in the scanner up to 2 hours.\n\nParticipants can agree to have a dye called gadolinium injected into their arm during the scan. This brightens the pictures.\n\nParticipants can agree to take a drug called a vasodilator. This helps detect areas of the heart with abnormal blood supply. Scans of the heart are taken before, during, and after they get the medicine. The drug may cause temporary chest pain or shortness of breath. They may get other drugs to relieve these symptoms.\n\nSponsoring Institution: National Heart, Lung, and Blood Institute",[577],"CAD",[579,580,581,582,583],"1.5 T CMR","Low SAR CMR","Gadolinium","Regadenoson","Adenosine",{"date":535,"type":44},{"date":586,"type":44},"2018-01-05",{"date":588,"type":22},"2028-05-31",{"name":50,"class":51},{"id":591,"slug":592,"hasResults":12,"nctId":593,"briefTitle":594,"officialTitle":595,"acronym":4,"eligibilityCriteria":596,"healthyVolunteers":158,"sex":17,"minAge":597,"maxAge":60,"enrollmentInfo":598,"targetDuration":4,"studyType":138,"phases":4,"briefSummary":600,"conditions":601,"keywords":602,"overallStatus":76,"whyStopped":4,"lastUpdateSubmitDate":533,"lastUpdatePostDateStruct":604,"startDateStruct":605,"completionDateStruct":607,"leadSponsor":609,"locationsCount":52},"100250836","human-biospecimen-procurement-protocol-biorepository-to-support-translational-research-to-identify-disease-mechanisms-100250836","NCT02543996","Human Biospecimen Procurement Protocol: Biorepository to Support Translational Research to Identify Disease Mechanism(s)","Human Biospecimen Procurement and Analysis to Support Translational Research to Identify Genetic Etiology and Disease Mechanism(s) in Rare Genetic Vascular\u002FCardiovascular Diseases","* INCLUSION CRITERIA (SUBJECTS MUST MEET ONE OF THE FOLLOWING):\n* Age: older than 1 month of age\n* Affected pregnant women if they have been referred with a known or suspected pathology or if they become pregnant while on study.\n* Unaffected related pregnant women (including spouses\u002Fpartners) for cord blood and tissue collection (surgical waste) only at the time of delivery.\n* Cognitively impaired individuals that are affected\n* Cognitively impaired individuals that are related to an affected subject.\n* Subjects willing to provide informed consent.\n\nEXCLUSION CRITERIA:\n\n* Healthy volunteers unable to give informed consent\n* Cognitively impaired individuals who are not affected\n* Cognitively impaired individuals who are not related to affected subjects.","1 Month",{"count":599,"type":22},10000,"Background:\n\nStudies show that rare genetic variants might lead to diseases. Researchers want to collect blood and tissue samples so they can study them and better understand diseases.\n\nObjective:\n\nTo collect blood and tissue samples for studies to identify underlying causes of disease.\n\nEligibility:\n\nPeople of all ages\n\nDesign:\n\nParticipants will have blood and\u002For tissue samples collected.\n\nSamples can be collected at the NIH Clinical Center. Participants doctors can collect the samples and send them to NIH. NIH staff can collect samples off site.\n\nFor blood samples, blood is taken from an arm vein using a needle.\n\nTissue collection may involve:\n\nBuccal smear: Cells are collected by scraping the inside of the cheek with a cotton swab.\n\nSaliva collection: Participants spit into a cup.\n\nSkin biopsy: A special needle takes a very small skin sample.\n\nSurgical waste tissue: If participants have surgery, NIH may receive samples of tissue that\n\nwould routinely be removed.\n\nUmbilical cord or cord blood collection: If a participant has a baby, NIH may receive a\n\nsmall piece of the umbilical cord or blood from the cord once the baby is delivered.\n\n...",[249,163],[390,170,169,603,145],"Rare Diseases",{"date":535,"type":44},{"date":606,"type":44},"2015-09-17",{"date":608,"type":22},"2050-05-22",{"name":50,"class":51},{"id":611,"slug":612,"hasResults":12,"nctId":613,"briefTitle":614,"officialTitle":615,"acronym":4,"eligibilityCriteria":616,"healthyVolunteers":12,"sex":332,"minAge":18,"maxAge":60,"enrollmentInfo":617,"targetDuration":4,"studyType":23,"phases":619,"briefSummary":620,"conditions":621,"keywords":622,"overallStatus":76,"whyStopped":4,"lastUpdateSubmitDate":533,"lastUpdatePostDateStruct":627,"startDateStruct":628,"completionDateStruct":630,"leadSponsor":632,"locationsCount":52},"100193865","phase-1-nebulized-or-inhaled-albuterol-for-lymphangioleiomyomatosis-100193865","NCT01799538","Nebulized or Inhaled Albuterol for Lymphangioleiomyomatosis","Bronchodilator Effects of Nebulized Versus Inhaled Albuterol in Subjects With Lymphangioleiomyomatosis","* INCLUSION CRITERIA:\n* Diagnosis of LAM either by tissue biopsy, evidence of lung and other organ involvement (renal angiomyolipomas, chylous effusions, lymphangioleiomyomas), high serum levels of vascular endothelial growth factor D (VGEF-D)(1) or a diagnosis of TSC associated with cystic lung lesions.\n* Age 18 years or over\n* Evidence of airflow obstruction: FEV1\u002FVC ratio \\\u003C fifth percentile of predicted normal and an FEV(1) \\\u003C80% predicted of the normal values.\n\nEXCLUSION CRITERIA:\n\nSubjects will be excluded from the study if they meet one or more of the following criteria:\n\n* History of hypersensitivity to albuterol or any of its components.\n* Moderate or large pleural effusions (chest x-ray and or CT scan procedure completed under Protocol 95-H-0186)\n* History of seizures other than during infancy\n* Inability to withhold bronchodilators for 24 hours\n* Cognitive Impairment\n* Age less than 18 years\n* Male sex\n* Status-post lung or kidney transplantation\n* Pregnant or breast feeding (women of childbearing potential will undergo a blood or urine pregnancy test under Protocol 95-H-0186).\n* Treatment with monoaminoxidase inhibitors, tricyclic antidepressants or Beta-adrenergic receptor antagonists or long acting anticholinergic bronchodilators who are unable to be discontinued for at least seven days before enrollment.\n* Patients with URI, uncontrolled hyperthyroidism or severe gastro-esophageal reflux. Major systemic diseases (i.e., malignancy; myocardial infarction or unstable angina; type 1 diabetes, severe hypertension; liver cirrhosis).",{"count":618,"type":22},100,[115,406],"Background:\n\n\\- Lymphangioleiomyomatosis (LAM) is a rare type of lung disease that occurs almost exclusively in women. In LAM, muscle tissue grows in the lungs and starts to block the flow of air. It is a progressive disease, and in severe cases may require a lung transplant. One possible treatment to improve breathing in people with LAM is inhaled albuterol. Albuterol can be given in a metered dose inhaler (MDI) or with a nebulizer. Researchers want to compare these methods to see which method best improves lung function in women with LAM.\n\nObjectives:\n\n\\- To see whether a nebulizer or MDI can better improve lung function in women with LAM.\n\nEligibility:\n\n\\- Women at least 18 years of age who have impaired lung function because of LAM.\n\nDesign:\n\n* Participants will be screened with a physical exam and medical history. No lab tests will be needed for this study.\n* Participants will have a 3-day overnight stay at the National Institutes of Health. Those who are using long-acting inhalers will have to stop taking these drugs 1 week before the study.\n* Participants will receive either the nebulizer or two or four puffs of the inhaler. Four puffs of albuterol is a higher dose than is normally prescribed, and is being tested on this study.\n* Participants will have each treatment around the same time of day on each of the 3 days. Before and after taking the albuterol, participants will have lung function tests.",[296],[623,624,625,626],"Albuterol","Bronchodilator","Nebulizer","Metered Dose Inhaler",{"date":535,"type":44},{"date":629,"type":44},"2013-06-10",{"date":631,"type":22},"2027-11-01",{"name":50,"class":51},""]