National Heart, Lung, and Blood Institute (NHLBI)

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Evaluating a Heart Magnetic Resonance Imaging (MRI) Procedure and the Effect of Fish Oil Supplementation in People Who Have Recently Had a Heart Attack (The PROSPECT-CMR Study)

Doctors use magnetic resonance imaging (MRI) to obtain detailed pictures of the inside of the body. This study will evaluate a new MRI technique in people who have recently had a heart attack. Researchers will also examine the effect of fish oil supplementation on heart health in study participants.

Background information
Other unique IDs: 
591
1 R01 HL091157-01A1

Evaluating the Effectiveness of a Family Heart Health Educational Program (The FIT-Heart Study)

Coronary heart disease (CHD) affects millions of people in the United States and is an increasingly important health problem. People who have a family member with CHD may have a higher risk for developing CHD because of shared genetic factors and similar lifestyles. This study will evaluate the effectiveness of the Family Passport to Heart Health Program, which is a personalized screening and education program aimed at lowering CHD risk for family members of patients hospitalized with CHD.

Background information
Other unique IDs: 
593
R01 HL075101

Evaluating Genetic Factors That May Contribute to Elastin Function and the Development of Chronic Obstructive Pulmonary Disease

Recruitment status: 
Recruiting

Chronic obstructive pulmonary disease (COPD) is a lung disease that is primarily caused by cigarette smoking. The breakdown of elastin, a protein found in the lungs, can cause lung damage and may contribute to the development of COPD. Some people may be more prone to elastin damage and in turn to developing COPD than others. This study will examine whether genetic factors are responsible for altering elastin function and increasing the risk of developing COPD.

Background information
Trial ID: 
NCT00725309
Other unique IDs: 
576
P50 HL084922-01
Official title: 

Specialized Center of Clinically Oriented Research: Alveolar and Airway Mechanisms for COPD: Genetic Determinants: Elastin Quality and Quantity (Project 2)

Detailed description: 

COPD is a disease in which the lung airways are damaged and partly obstructed, making it difficult to breathe. There is no cure for this disease, and it is the fourth leading cause of death in the United States. Symptoms include coughing, excess mucus production, shortness of breath, wheezing, and chest tightness. The most common risk factor for developing COPD is cigarette smoking; however, only 15% to 20% of smokers are diagnosed with COPD in their lifetimes, suggesting that some smokers are more prone to developing COPD than others.

Number to be enrolled: 
400 patients

Sleep Loss and Energy Metabolism in People With Family History of Type 2 Diabetes.

Recruitment status: 
Recruiting

The use of energy from food changes when people sleep. However, it is still not known if differences in the amount of nighttime sleep have an effect on the amount of energy that people who have a relative with type 2 diabetes (parent, sibling, or grandparent) use to perform their daily activities. This study is being done to test the hypothesis that the daily use of energy in people who have a history of type 2 diabetes in their family will be different after they have slept short hours for 16 days in comparison to when they have slept longer hours for 16 days.

Background information
Trial ID: 
NCT00724087
Other unique IDs: 
R01HL089637
16079A-S4
Official title: 

Sleep, Energy Metabolism and Diabetes Risk.

Detailed description: 

Study participants will complete two 16-day inpatient stays in the sleep laboratory of the University of Chicago Clinical Resource Center that will be scheduled at least 4 weeks apart. Bedtime duration will be set at 5.5 hours per night during one of these stays and at 8.5 hours per night during the other. No daytime naps will be allowed. Study participants will be served regular daily meals including breakfast, lunch, dinner, and a bedtime snack. On weekdays all participants will engage in simulated "office work" in the sleep laboratory.

Number to be enrolled: 
16 patients

Analyzing Genetic Factors Involved in Blood Pressure Changes Due to Salt and Potassium Intake (The GenSalt Study)

High blood pressure is a serious health problem. In terms of diet recommendations, people with this condition are encouraged to eat a low sodium and high potassium diet. It is believed that genetics may play a role in the development of high blood pressure and may affect changes in blood pressure levels, including changes brought on by sodium and potassium. This study will identify genetic factors that may influence blood pressure changes due to increased salt or potassium intake in people with mildly elevated blood pressure and in their family members.

Background information
Other unique IDs: 
1412
U01 HL072507

Fitness and Sleep in People With Family History of Type 2 Diabetes.

Currently, it is not known if the amount of nighttime sleep has any effect on the overall physical fitness, and on how much energy do people who have a relative with type 2 diabetes (parent, sibling, or grandparent) use to perform activities of daily living. This study will test the hypothesis that individual differences in nighttime sleep duration are related to differences in the amount of energy used to perform activities of daily living and the overall level of physical fitness of the individual.

Background information
Other unique IDs: 
R01HL089637
16079A-S1

Sleep Loss and Glucose Metabolism in People With Family History of Type 2 Diabetes.

Recruitment status: 
Recruiting

The use of sugar and starch-like foods for energy (carbohydrate metabolism) changes when people sleep. However, it is still not known if differences in the amount of nighttime sleep have an effect on the carbohydrate metabolism of people who have a relative with type 2 diabetes (parent, sibling, or grandparent). This study is being done to test the hypothesis that the carbohydrate metabolism of people who have a history of type 2 diabetes in their family will be different after they have slept short hours for 10 days in comparison to when they have slept longer hours for 10 days.

Background information
Trial ID: 
NCT00721019
Other unique IDs: 
16079A-S3
R01HL089637
Official title: 

Sleep, Energy Metabolism and Diabetes Risk.

Detailed description: 

Study participants will complete two 10-day inpatient stays in the sleep laboratory of the University of Chicago Clinical Resource Center scheduled at least 4 weeks apart. Bedtime duration will be set at 5 hours per night during one of these stays and 8.5 hours per night during the other. No daytime naps will be allowed. Study participants will be served regular daily meals including breakfast, lunch, dinner, and a bedtime snack. On weekdays all participants will engage in simulated "office work" while in the sleep laboratory.

Number to be enrolled: 
16 patients

Glucose Metabolism and Sleep in People With Family History of Type 2 Diabetes.

Recruitment status: 
Recruiting

The use of sugar and starch-like foods for energy (carbohydrate metabolism) changes when people sleep. However, it is still not known if differences in the amount of nighttime sleep have an effect on the carbohydrate metabolism of people who have a relative with type 2 diabetes (parent, sibling, or grandparent). This study is being done to test the hypothesis that individual differences in habitual sleep duration may be related to differences in the carbohydrate metabolism of people who have a history of type 2 diabetes in their family.

Background information
Trial ID: 
NCT00720889
Other unique IDs: 
R01HL089637
16079A-S2
Official title: 

Sleep, Energy Metabolism and Diabetes Risk.

Detailed description: 

On two consecutive inpatient days, the participants in this study will undergo two different tests. The first test will determine how much insulin can their body produce in response to an intravenous glucose infusion over a period of several hours. The second test will determine how effective is the action of the sugar-processing hormone, insulin, in their body when it is infused intravenously together with glucose over a period of several hours.

Number to be enrolled: 
30 patients

Natural Killer Cells and Bortezomib to Treat Cancer

Trial phase: 
Phase I
Recruitment status: 
Recruiting

Natural killer (NK) cells are white blood cells that have a limited ability to kill cancer cells. This ability might be enhanced if they are given 24 hours after an injection of the drug bortezomib. This study will determine the following:

  • What dose of NK cells can be given safely to subjects with metastatic solid tumors or leukemia.
  • The effectiveness and side effects of NK cell therapy
  • How the body handles NK cells.

People between 18 and 70 years of age who have a solid tumor or leukemia, and for whom standard treatments are not effective, may be eligible for this study. Participants undergo the following procedures: Apheresis to collect NK cells. For this procedure, a catheter (plastic tube) is placed in a vein in the subject's arm. Blood flows from the vein into a cell separator machine, which separates the white cells from the other blood components. The white cells are extracted and the rest of the blood is returned to the body through a second tube placed in a vein in the other arm. Chemotherapy with the drug pentostatin to suppress the immune system and prevent it from attacking the NK cells that will be infused. Chemotherapy with bortezomib to increase NK cell function. Infusion of the NK cells. In this dose-escalating study, successive groups of patients entering the study receive increasingly higher numbers of cells to determine the highest safe dose level. Up to four dose levels may be studied. Interleukin-2 drug therapy to maintain NK cell activity. Evaluations during therapy including:

  • Clinical assessment, history and review of medications
  • Blood draws for routine and research tests.
  • Pharmacokinetics study after the NK infusion to see how the body handles the cells. For this test, the number of NK cells in the blood are measured over time. This requires drawing about 1 teaspoon of blood at 15 minutes, 30 minutes, 1, 2, 4, 8, 12, and 24 hours after the infusion (day 1); then every 24 hours on days 2 through 7, then once on days 10, 14, and 21.
  • Bone marrow biopsy (subjects with leukemia only).
  • Chest x-ray.
  • CT scan, bone scan and PET scan, if indicated, for disease evaluation.

Patients who respond well after one treatment cycle may be eligible to continue NK cell therapy.

Background information
Trial ID: 
NCT00720785
Other unique IDs: 
080186
08-H-0186
Official title: 

Safety and the Anti- Tumor Effects of Escalating Doses of Adoptively Infused Ex Vivo Expanded Autologous Natural Killer (NK) Cells Against Metastatic Cancers or Hematological Malignancies Sensitized to NK-TRAIL Cytotoxicity With Bortezomib

Detailed description: 

Natural killer (NK) cells are innate immune lymphocytes that are identified by the expression of the CD56 surface antigen and the lack of CD3. Unlike antigen specific T cells, NK cells do not require the presence of a specific tumor antigen for the recognition and killing of cancer cells. Our in vitro studies have demonstrated that pretreatment of malignant cells with bortezomib significantly enhances NK-mediated tumor cytotoxicity by sensitizing cells to TNF-related apoptosis-inducing ligand (TRAIL). TRAIL is a member of tumor necrosis factor family of cytokines that promotes apoptosis.

Number to be enrolled: 
32 patients

Effect of the HIV Protease Inhibitors Atazanavir and Lopinavir/Ritonavir on Cardiovascular Disease Risk Factors

Recruitment status: 
Completed

HIV protease inhibitors (PIs) are a class of antiretroviral drugs used to inhibit viral replication. They do so by interfering with a key step in the replication process. Some HIV PIs have been associated with an increased risk of adverse cardiovascular side effects. Further study is needed, however, to assess the full extent of effect of newer HIV PIs, including atazanavir and lopinavir/ritonavir, on cardiovascular disease risk. This study will compare the effects of atazanavir, lopinavir/ritonavir, and placebo on certain cardiovascular disease risk factors in healthy people without HIV.

Background information
Trial ID: 
NCT00720590
Other unique IDs: 
573
R01 HL072711-01
Official title: 

Effect of HIV-1 Protease Inhibitors on Endothelial Function and Glucose Metabolism in Normal, HIV-Uninfected Subjects: Atazanavir or Lopinavir/Ritonavir or Placebo

Detailed description: 

Antiretroviral therapy for HIV, particularly with the use of PIs, is associated with an increased risk of heart attack. Specific cardiovascular side effects seen with the use of some PIs include insulin resistance, abnormal blood lipid levels, and endothelial dysfunction (abnormalities in the cells that line the inner surface of blood vessels). Past studies have shown that treatment with indinavir, an older PI, results in significant endothelial dysfunction, which may be the main cause for the increase in cardiovascular risk.

Number to be enrolled: 
30 patients
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