199 Clinical Trials for Various Conditions
The purpose and objective of this study is to improve cholesterol treatment among blood donors with FH (Familial Hypercholesterolemia).
The objective of this clinical investigation is to evaluate the pulse oximeter devices for screening prospective blood donors. The purpose study is to report on the accuracy of noninvasive hemoglobin (SpHb) as compared to hemoglobin measurements obtained from a laboratory hematology analyzer in a blood donation setting.
This is an open-label, non-randomized study. Volunteers will be vaccinated with the typhoid oral vaccine, Vivotif. Vivotif has been licensed by the Food and Drug Administration (FDA) for travelers to developing countries. Volunteers will also be asked to provide blood, saliva, and stool specimens over a follow-up time period of up to eight years. The specimens obtained in this clinical research study will be used to further the investigator's understanding of the protective immunological mechanisms that can be elicited systemically and may be applicable to other enteric pathogens.
This is an open-label, non-randomized study. Volunteers will be vaccinated with the oral cholera vaccine, Vaxchora. Vaxchora has been licensed by the Food and Drug Administration (FDA) for travelers to developing countries. Volunteers will also be asked to provide blood specimens over a follow-up time period of up to eight years. The specimens obtained in this clinical research study will be used to further the investigator's understanding of the protective immunological mechanisms that can be elicited systemically and may be applicable to other enteric pathogens.
This study examines the effects of a web-based motivational interview on 1) internal motivation to donate blood; 2) donor autonomy, competence and relatedness; and 3) donation intention and behavior. The study also evaluates whether group differences in donation intention and behavior are mediated by autonomy, competence, and relatedness, and in turn, internal motivation.
Background: Zika virus is mostly passed on by the bite of an infected mosquito. It usually causes mild illness. But in pregnant women it can cause serious birth defects to the baby. The virus can also spread by blood transfusion and sexual intercourse. This is why the U.S. Food \& Drug Administration (FDA) recommended that people should not give blood if possibly exposed to Zika virus. Dengue virus and chikungunya virus are passed by the same mosquitoes as Zika virus. These can cause severe reactions if passed through transfused blood. Donated blood is usually not tested for these three viruses. Researchers want to count the infections in people who have been exposed because of travel or sexual exposure. They want to learn the risk these viruses might pose to the U.S. blood supply. They also want to study the natural history of these viruses by following infected people over time. Objective: To study the risk of Zika, dengue, and chikungunya viruses to the U.S. blood supply. Eligibility: Adults age 18 or older who were turned down for donating blood because of possible exposure to certain viruses. Design: Participants will have blood and urine tests. They will answer questions about their travel. They will be called in about a week with virus test results. Participants with negative results do not have any more study visits. Participants with positive results will be asked to stay in the study for 6 months. They will have weekly clinic visits and tests until results are negative for 2 straight weeks. Once test results are negative, they will have monthly visits. Visits will include physical exams, blood and urine samples, and optional semen samples from men. Most people will have 3-4 weekly visits and 5 monthly visits.
Blood donation has been proposed to be associated with reduced risk of cardiovascular disease, but the effects of phlebotomy on vascular function in human subjects have not been well characterized. A prospective randomized double-blind study was undertaken to determine the effects of iron loss and red blood cell loss induced by serial phlebotomy on vascular endothelial function in the brachial artery.
The purpose of this study is to determine whether enhancing blood donor competence, autonomy, and/or relatedness increases intrinsic motivation to donate and improves donor retention.
A longitudinal, randomized, controlled, single-center Phase IV clinical trial will be performed to assess changes in bone mineral density (BMD) among voluntary apheresis blood donors. The primary outcome measure will be clinically significant decline in BMD at the lumbar spine assessed by dual-energy x-ray absorptiometry (DXA).
This study develops a motivational interview and implementation intention intervention for blood donor retention and tests the efficacy of this new approach among first-time, Group O donors.
The purpose of this study is to determine (1) the role of ferritin testing to screen for iron depletion in donors at risk of low iron levels (2) the effectiveness of oral iron replacement therapy on the repletion of iron stores in donors, and (3) the feasibility of blood centers to routinely distribute oral iron replacement therapy to donors.
The objective of this study is to test individual donor samples (IDSs) with the investigational Dengue Assay on the TIGRIS System and to further characterize the Dengue Assay in the clinical setting.
The objective of this study is to test individual donor samples (IDSs) with the investigational Dengue Assay on the TIGRIS System and to further characterize the Dengue Assay in the clinical setting.
Both prospective and retrospective (look back) study of blood donors for laboratory evidence of babesia microti infection. Two laboratory methodologies will be utilized: 1. - PCR, to look for the presence of B.microti in whole blood 2. - IFA, to look for significant titers of B.microti antibody
The purpose of this protocol is to characterize the performance of CaridianBCT's Spectra Optia Apheresis System, when used to collect mononuclear cells (MNCs) and cluster of differentiation 34 (CD34) positive cells from healthy nonmobilized blood donors and healthy G-CSF (granulocyte colony stimulating factor) mobilized blood donors, respectively.
Blood donors are a precious community resource. Each month at Blood Center of Wisconsin (BCW), 200 men and 600 women over age 50 are turned away ("deferred") because of anemia. In those over 50, anemia may signal serious underlying disease such as colorectal cancer (CRC). CRC is the #3 cause of cancer death in Wisconsin with more than 1,000 deaths in 2006. Yet with proper testing CRC outcomes can be improved by early diagnosis. This project will focus on a population of deferred older blood donors to develop and test educational materials that will motivate donors to seek medical attention for their anemia, so that the underlying cause is diagnosed and treated. This project has the potential to lead to better CRC outcomes in Wisconsin blood donors.
Blood donors who have a low fingerstick hemoglobin level are usually deferred from donating. A possible solution to the problem of repeated deferrals might be for Blood Banks to offer donors with low hemoglobin levels oral iron supplements. To determine the feasibility of such a program, this study will: * Determine the frequency of iron deficiency in first-time and repeat blood donors * Examine the effects of long-term blood donation on donor hemoglobin levels and iron stores * Compare body iron stores in donors who have low hemoglobin values with that of donors who have acceptable hemoglobin values at the time of donation * Determine what conditions other than iron deficiency lead to low hemoglobin levels in blood donors * Determine the safety and effectiveness of giving oral iron tablets to donors with low hemoglobin levels * Monitor the effect of oral iron administration on donor satisfaction and donor retention. First-time and repeat blood donors at the NIH Clinical Center Blood Bank 18 years of age and older may be eligible for this study. Participants include prospective donors who have an acceptable hemoglobin value at the time of donation and those whose hemoglobin level is determined to be too low for donation. All participants do the following: * Answer medical questions about their diet, health, and family history of blood disorders. * Have blood samples drawn from their arm for testing blood cell counts, iron stores, and other hemoglobin-related tests as appropriate. Donors with low hemoglobin also: * Take iron supplements (ferrous sulfate) to replenish iron stores. (Donors who have previously had unpleasant side effects from ferrous sulfate are offered ferrous gluconate as an alternative.) * Undergo evaluation with medical screening and laboratory tests at the time of future blood donations.
Many individuals experience negative reactions when donating blood, including dizziness, lightheadedness, or fainting. Such reactions may discourage them from donating again. This study will evaluate the effectiveness of pre-donation water consumption and a muscle tensing exercise during donation to reduce negative reactions among new blood donors. This study will also evaluate whether reducing negative reactions increases the likelihood of donors returning to give blood in the future.
This study will evaluate the accuracy of an experimental test method called nucleic acid amplification technology (NAT) in detecting human immunodeficiency virus (HIV) and hepatitis C virus (HCV). This test amplifies the nucleic acid in a virus more than a million-fold, allowing early detection of minute quantities of virus in the blood. Blood donors to the National Institutes of Health's Department of Transfusion Medicine (blood bank) will have their blood screened with transcription mediated amplification, a type of NAT test. Donors whose blood is found positive for HIV or HCV by NAT testing will be notified and asked to participate in this study. Those who agree will provide a blood sample about once a week for 3 months. The samples will be tested with additional assays to detect evidence of HIV or HCV infection. If the test results are confirmed positive, no more blood samples will be collected. The results of the tests and their significance will be explained to participants. It is anticipated that NAT screening will reduce the risk of transfusion-related HIV transmission from the current 1 in 650,000 to 1 in a million and the risk of HCV transmission from the current 1 in 100,000 to 1 in 350,000. It is possible that these tests will completely eliminate the risk of transmitting these diseases through blood transfusion.
Hepatitis C is a disease of the liver caused by the Hepatitis C Virus (HCV). Patients with hepatitis C may feel well and show no signs or symptoms of being ill. However, researchers would like to study the long-term effects of this disease. Volunteer blood donors diagnosed with chronic hepatitis C viral (HCV) and various levels of liver enzyme activity will be offered a complete medical evaluation and liver biopsy. The tests will enable researchers to provide the patients with an idea of how severe their liver disease is. The virus and patient will be studied in order to understand why patients with hepatitis C develop different levels of liver damage.
Iron has been proposed to contribute to atherogenesis in humans by facilitating the oxidation of lipoproteins. This observational study will evaluate the association between frequency of blood donation - expected to be associated with relatively reduced body iron stores in frequent donors - and carotid atherosclerosis. The primary outcome variable will be whether the presence and extent of asymptomatic carotid atherosclerosis as measured by ultrasound is greater in infrequent (less than or equal to 1 donations/year greater than or equal to 5 years) vs. frequent (greater than or equal to 4 donations/year greater than or equal to 5 years) blood donors. Body iron stores, lipid and hemostatic parameters, nitric oxide formation, inflammatory parameters, and markers of vascular oxidative stress will be analyzed as secondary outcome measures. Laboratory analysis and ultrasound testing will be performed blinded to the patient's phlebotomy and iron status. Sixty frequent (n=40 males greater than 40 y/o, n=20 females greater than 50 y/o) and 60 infrequent (n=40 males greater than 40 y/o, n=20 females greater than 50 y/o) blood donors will be recruited for this study from the Department of Transfusion Medicine, W. G. Magnuson Clinical Center. All donors will be assessed for study eligibility and cardiovascular risks during the screening visit. The presence of atherosclerotic lesions by carotid ultrasound and secondary outcome parameters will be assessed during a second visit.
In this study, high school donors will be asked about their blood donation-related fears prior to their donation. Half of the donors reporting fear will be assigned to a brief coping skills intervention.
This study will evaluate a new blood collection and filtration system that is intended to be used to collect, filter, separate and store red blood cells and, separately, plasma. The new blood collection and filtration system will be compared to an already-approved and currently used system. Further, this study will evaluate new processing conditions relative to the individual components of the collection and filtration system. All study participants will donate two units of whole blood with individual units being donated at least 56 days apart. One unit of whole blood will be donated with the new system, and the other unit will be collected with the already-approved system. A subset of the donors (approximately 24 of the 120 participants) will have a small quantity of their red blood cells injected back into their body 42-days after they were donated in order to evaluate how well the red blood cells survive. Blood and blood products from all donors will be analyzed the day of collection and after storage (plasma after at least 30 days of storage and red blood cells after exactly 42 days of storage).
This protocol is designed to provide a mechanism for the Department of Transfusion Medicine, Clinical Center to collect and process blood components from paid, healthy volunteer donors for distribution to NIH intramural investigators and FDA researchers for in vitro laboratory use. Donors meeting research donor eligibility criteria will be recruited to donate blood and blood components by standard phlebotomy and apheresis techniques. The investigational nature of the studies in which their blood will be used, and the risks and discomforts of the donation process will be carefully explained to the donors, and a signed informed consent document will be obtained. Donors will be compensated according to an established schedule based on the duration and discomfort of the donation. NIH and FDA investigators requesting blood components for research use will be required to submit an electronic (Web-based) memo of request, briefly describing the nature of the research, and providing assurance that samples provided through this protocol will be used solely for in vitro and not for in vivo research. This protocol also provides a detailed schema for careful and frequent laboratory safety monitoring of repeat research apheresis donors. Blood components for research use will be distributed with a unique product number, and the DTM principal and associate investigators will serve as the custodians of the code that links the product with a donor s identity. The nature of the in vitro studies in which the blood and components collected in this study will be used is not the subject of this protocol, and is not possible to describe, since it involves basic investigative efforts in greater than 170 different NIH and FDA laboratories. The intent of this protocol is not to approve the research itself, but to provide adequate and complete informed consent for the donor, and to assure that the education, counseling, and protection of the study subjects (research blood donors) is performed in accordance with IRB, OHSR, OPRR and other applicable Federal regulatory standards...
Red Blood Cell - IMProving trAnsfusions for Chronically Transfused recipients (RBC-IMPACT) is an observational cohort study to assess donor, component, and recipient factors that contribute to RBC efficacy in chronically and episodically transfused patients. The objective of the study is to determine how specific genetic and non-genetic factors in donors and recipients may impact RBC survival after transfusion - in short, what factors on both the donor and recipient side may improve the efficacy of the transfusion.
The objective of this study is to make T-cell depleted stem cells from a family member who is a half match (haplo-identical) available on an expanded access basis to patients receiving one or two unrelated cord blood transplants who are at a higher risk of not engrafting in a safe amount of time. The purpose of the related stem cells is the give the bone marrow a "jump start" towards recovery. Ultimately, the cord blood cells will grow and permanently rescue the bone marrow.
The purpose of this study is to validate that single units of RBCs collected by the Haemonetics MCS®+ 8150 system using LN832 disposable sets during an interrupted double red cell collection protocol meet all in vitro FDA requirements for non-leukoreduced red blood cells, and to provide data to support the 510(k) clearance of the MCS®+ 8150 system using LN832 disposable sets for this intended use.
The purpose of this study is to determine the effects of transfusion of fresh and stored blood on patients. The investigators hope to test: * whether a similar effect (older stored blood is associated with worse outcomes) is seen in chronically transfused patients with hemoglobinopathies. This patient population will also allow the investigators to test whether iron- chelation therapy is beneficial in this setting. * whether washing or cryopreserving the red blood cells has any effect on this outcome. These findings may explain the immunomodulatory effects of older stored blood in patients and will help us develop safer transfusion products for patients.
The purpose of the study is to screen blood donors for the presence of NS1 antigen of the dengue virus at the American Red Cross in Puerto Rico region (and Monroe County, Florida) using the Platelia Dengue NS1 Ag enzyme immunoassay.
Unrelated matched donor (cord blood, bone marrow or peripheral blood) allogeneic stem cell transplantation (UDAlloSCT) with either myeloablative or reduced intensity conditioning will be well tolerated and result in a high degree of engraftment in patients with selected malignant and non malignant disorders.