DR20 DataRelease
Release Date: 02/01/2017
| SDY614: Mayo Clinic Smallpox Vaccine Immunogenetics Replication Study | |||||||||||||||
| Status: | New | ||||||||||||||
| Description: | Smallpox Vaccine Immunogenetics | ||||||||||||||
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| DOI: | 10.21430/M3EEL6ILMK | ||||||||||||||
| Subjects: | 1061 | ||||||||||||||
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| Clinical Assessments: | None | ||||||||||||||
| SDY691: HLA and KIR Haplotype Sequencing | |||||||
| Status: | New | ||||||
| Description: | Assay development for complete HLA and KIR haplotype sequencing from cell lines | ||||||
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| DOI: | 10.21430/M3RES1FXTG | ||||||
| Subjects: | 97 | ||||||
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| Clinical Assessments: | None | ||||||
| SDY775: Evaluating differences between healthy placental microbiome and contamination control sample microbiomes | |||||||
| Status: | New | ||||||
| Description: | Placental samples from healthy deliveries were compared to an extensive set of bacterial contamination controls as well as to oral and vaginal samples from the same women. This control study was unable to distinguish bacterial species and abundance between placental and contamination control samples | ||||||
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| DOI: | 10.21430/M3PZM1ERD2 | ||||||
| Subjects: | 7 | ||||||
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| Clinical Assessments: | None | ||||||
| SDY820: Human Immune Signature of Mycobacterium Tuberculosis infection. (See SDY1324 for sorted cell gene expression data) | |||||||||
| Status: | New | ||||||||
| Description: | The human immune signature of latent Mycobacterium tuberculosis infected patients as well as BCG vaccinated and BCG non-vaccinated individuals was studied by flow cytometry | ||||||||
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| DOI: | 10.21430/M3D02NOSVH | ||||||||
| Subjects: | 60 | ||||||||
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| Clinical Assessments: | None | ||||||||
| SDY827: An Interactive Reference Framework for Modeling a Dynamic Immune System | |||||||
| Status: | New | ||||||
| Description: | We leveraged mass cytometry, a platform that allows measurement of multiple parameters simultaneously at the single-cell level, to initiate a reference map of the immune system. By combining the throughput of flow cytometry with the resolution of mass spectrometry, this hybrid technology enables the simultaneous quantification of 40 parameters in single cells. Use of mass cytometry allows fluorophore reporters to be replaced with isotopically-pure, stable heavy metal ions conjugated to antibodies or affinity reagents. These reporter ions are then quantified by time-of-flight mass spectrometry to provide single-cell measurements, enabling a more detailed characterization of complex cellular systems for a robust reference map. | ||||||
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| DOI: | 10.21430/M3JX1JSOLB | ||||||
| Subjects: | 5 | ||||||
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| Clinical Assessments: | None | ||||||
| SDY887: Defective signaling in aging | |||||||
| Status: | New | ||||||
| Description: | Pilot year. Despite the importance of the immune system in many diseases, there are currently no objective benchmarks of immunological health. In an effort to indentify benchmarks of immunological health, influenza vaccination was used in 10 young (20-30 years) and 19 older subjects (60 to 89 years) as models for strong and weak immune responses, respectively. Serological responses to influenza strains as well as a wide variety of other parameters, including gene expression, antibodies to hemagglutinin peptides, serum cytokines, cell subset phenotypes and in vitro cytokine stimulation were measured. Using machine learning, nine variables predicting antibody response with 84% accuracy were identified. Two of these variables are involved in apoptosis, which positively associated with the response to vaccination and was confirmed to be a contributor to vaccine responsiveness in mice. The identification of these biomarkers provides new insights into what immune features may be most important for immune health. | ||||||
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| DOI: | 10.21430/M33JMYFLF1 | ||||||
| Subjects: | 26 | ||||||
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| Clinical Assessments: | None | ||||||
| SDY939: Pathologically expanded peripheral B cell-helper T cells in Rheumatoid Arthritis | |||||||
| Status: | New | ||||||
| Description: | CD4+ T cells are central mediators of autoimmune pathology; however, | ||||||
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| DOI: | 10.21430/M3OLBPJIB1 | ||||||
| Subjects: | 4 | ||||||
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| SDY91: Rituximab for the Treatment of Wegener's Granulomatosis and Microscopic Polyangiitis (RAVE ITN021AI) | |||||||||||
| Status: | Updated | ||||||||||
| Description: | Current conventional therapies for ANCA-associated vasculitis (AAV) are associated with high incidences of treatment failure, disease relapse, substantial toxicity, and patient morbidity and mortality. Rituximab is a monoclonal antibody used to treat non-Hodgkin's lymphoma. This study will evaluate the efficacy of rituximab with glucocorticoids in inducing disease remission in patients with severe forms of AAV (WG and MPA). The study consists of two phases: a 6-month remission induction phase, followed by a 12-month remission maintenance phase. All participants will receive at least 1 g of pulse intravenous methylprednisolone or a dose-equivalent of another glucocorticoid preparation. Depending on the participant's condition, he or she may receive up to 3 days of intravenous methylprednisolone for a total of 3 g of methylprednisolone (or a dose-equivalent). During the remission induction phase, all participants will receive oral prednisone daily (1 mg/kg/day, not to exceed 80 mg/day). Prednisone tapering will be completed by the Month 6 study visit. Participants will then be randomly assigned to one of two arms. Arm 1 participants will receive rituximab (375 mg/m^2) infusions once weekly for 4 weeks and cyclophosphamide (CYC) placebo daily for 3 to 6 months. Arm 2 participants will receive rituximab placebo infusions once weekly for 4 weeks and CYC daily for 3 to 6 months. During the remission maintenance phase, participants in Arm 1 will discontinue CYC placebo and start oral azathioprine (AZA) placebo daily until Month 18. Participants in Arm 2 will discontinue CYC and start AZA daily until Month 18. Participants who fail treatment before Month 6 will be crossed over to the other treatment arm unless there are specific contraindications. Participants in either group who reach clinical remission before they complete 6 months of therapy may switch from CYC/placebo to AZA/placebo if directed by their physicians.All participants will be followed for at least 18 months. Initially, study visits are weekly, progressing to monthly and then quarterly visits as the study proceeds. Blood collection will occur at each study visit. |
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| DOI: | 10.21430/M3TK42R0QR | ||||||||||
| Subjects: | 197 | ||||||||||
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| SDY212: Apoptosis and other immune biomarkers predict influenza vaccine (TIV 2008) responsiveness | |||||||||||||
| Status: | Updated | ||||||||||||
| Description: | Despite the importance of the immune system in many diseases, there are currently no objective benchmarks of immunological health. In an effort to indentify benchmarks of immunological health, influenza vaccination was used in 30 young (20-30 years) and 59 older subjects (60 to 89 years) as models for strong and weak immune responses, respectively. Serological responses to influenza strains as well as a wide variety of other parameters, including gene expression, antibodies to hemagglutinin peptides, serum cytokines, cell subset phenotypes and in vitro cytokine stimulation were measured. Using machine learning, nine variables predicting antibody response with 84% accuracy were identified. Two of these variables are involved in apoptosis, which positively associated with the response to vaccination and was confirmed to be a contributor to vaccine responsiveness in mice. The identification of these biomarkers provides new insights into what immune features may be most important for immune health. | ||||||||||||
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| DOI: | 10.21430/M37NGTHMDS | ||||||||||||
| Subjects: | 91 | ||||||||||||
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| Clinical Assessments: | None | ||||||||||||
| SDY289: Live Kidney Donor Study (RELIVE-01) | |||||||
| Status: | Updated | ||||||
| Description: | The purpose of this study was to establish a multi-center kidney donor database containing renal failure, cardiovascular and overall mortality information for the complete cohorts of kidney donors who underwent living donor uninephrectomy. | ||||||
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| DOI: | 10.21430/M3DM0S6FPM | ||||||
| Subjects: | 8922 | ||||||
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| Assays: | None | ||||||
| Clinical Assessments: | None | ||||||
| SDY290: Live Kidney Donor Study - Cross-Sectional and Historical Cohort Study (RELIVE-04) | |||||||
| Status: | Updated | ||||||
| Description: | The goal of this study is to determine the long-term risks of donor nephrectomy, compared to appropriate control subjects. This study built on information generated from RELIVE-01, a separate but related retrospective study. Through direct contact with previous living kidney donors this study examined the contribution of living kidney donation to the future development of hypertension, proteinuria, renal insufficiency or renal failure and anemia, the potential through these factors or others for increased cardiovascular risk for clinical events including myocardial infarction (MI), congestive heart failure (CHF), need for coronary artery bypass grafting (CABG) or percutaneous coronary angioplasty (PTCA) revascularization, and the impact of living kidney donation on quality of life (QOL) and financial status, compared to applicable control subjects and populations. | ||||||
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| DOI: | 10.21430/M39RJDHJVB | ||||||
| Subjects: | 196 | ||||||
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| Assays: | None | ||||||
| Clinical Assessments: | None | ||||||
| SDY291: Live Kidney Donor Study -Renal Function Study (RELIVE-06) | |||||||
| Status: | Updated | ||||||
| Description: | As part of a cross-sectional study of living kidney donors from 5 to more than 50 years following donor nephrectomy, this study's goal is to accurately measure current Glomerular Filtration Rate (GFR), then to look at the change in GFR from pre to post donation and from early to late time points after donation. This study builds on information generated from RELIVE-01 and RELIVE-04. Through direct contact with previous living kidney donors, this study aims to quantify changes in renal function (measured GFR) from pre to early post donation using data already collected in a related retrospective study (RELIVE 01), and the change in renal function from early (in the first 2 years) post donation to late (beyond the first 2 years) post donation by repeating a GFR measurement. Cross-sectional GFR measurements from black donors compared to white donors matched for age, sex, weight and time from donation will provide data on differences in GFR late after donor nephrectomy by race. When compared to GFR estimates using predictive equations at each of these time points, we can evaluate the accuracy of estimated GFR in white and black donor populations. | ||||||
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| DOI: | 10.21430/M33MG60QVQ | ||||||
| Subjects: | 413 | ||||||
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| Assays: | None | ||||||
| Clinical Assessments: | None | ||||||
| SDY292: RELIVE Informed Consent Study (RELIVE-03) | |||||||
| Status: | Updated | ||||||
| Description: | The goal of this study was to study informed consent by the living donor. This study used surveys to evaluate the understanding of risk and psychological pressure that living organ donors felt when making the decision to donate. It compared participants' answers across geographic, racial and socio-economic backgrounds. | ||||||
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| DOI: | 10.21430/M3G310ZBSI | ||||||
| Subjects: | 636 | ||||||
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| Assays: | None | ||||||
| Clinical Assessments: | None | ||||||
| SDY293: Live Lung Donor Retrospective Study (RELIVE-02) | |||||||
| Status: | Updated | ||||||
| Description: | The purpose of this study is to determine the mortality, the early postoperative morbidity, and the occurrence of end stage lung disease for participants who underwent donor lobectomy between 1993 and 2006. Participants in this study have had donor lobectomy at the University of Southern California in Los Angeles or the Washington University Medical Center and Barnes-Jewish Hospital in St. Louis. | ||||||
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| DOI: | 10.21430/M3495BHP30 | ||||||
| Subjects: | 369 | ||||||
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| Assays: | None | ||||||
| Clinical Assessments: | None | ||||||
| SDY294: Live Lung Donor Cross-sectional Cohort Study (RELIVE-05) | |||||||
| Status: | Updated | ||||||
| Description: | The Live Lung Donor Cross-sectional Cohort Study (RELIVE-05) aimed to determine the effects of live lung donation on lung function, quality of life, morbidity, psychosocial status, satisfaction with live lung donation, and decision-making associated with live lung donation. This study built on the separate but related RELIVE-02 retrospective study that assessed the effects of live lung donation on survival and short-term morbidity. This multicenter cross-sectional cohort study invited the RELIVE-02 living former live lung donors to undergo questionnaire and pulmonary function test assessments to further determine the long-term outcomes of live lung donation. This study used preoperative donor pulmonary function data and normative data to assist with assessing the effects of live lung donation on lung donors. | ||||||
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| DOI: | 10.21430/M38LFF1QAA | ||||||
| Subjects: | 162 | ||||||
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| Assays: | None | ||||||
| Clinical Assessments: | None | ||||||
| SDY546: FACTOR ITN507ST: Study of Tolerant Kidney Transplant Recipients | |||||||
| Status: | Updated | ||||||
| Description: | Following kidney (renal) transplantation, one possible complication is rejection of the new kidney. This occurs as a results of the bodys immune system attacking (or rejecting) the newly transplanted kidney. After transplant, medicines known as immunosuppressive or anti-rejection drugs are given to transplant recipients to help prevent rejection of the transplanted kidney. If a transplant recipient stops taking these medicines, they almost always reject their transplanted kidney. However, in some exceptionally rare instances, transplant recipients who stop taking these drugs do not reject their kidney, and the kidney keeps working. The recipients are said at that point to tolerate the transplanted kidney, and this condition is referred to as tolerance. In this study, participants will be asked to provide consent for the collection of extensive demographic and clinical information; medical histories; and blood and urine samples. Blood and urine samples collected will be used to perform specific assays to help define mechanisms of tolerance. Originally the study included 11 groups as listed; however, at present only groups 1,4, and 8 remain active. Whereas the initial study duration was 6 years, this was extended to 11 years in order to follow over more extended time a B cell signature identified for tolerant kidney subjects and how this signature may change. (Refer to publications section: Newell, Kirk et al, J Clin Invest. 2010). | ||||||
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| DOI: | 10.21430/M3SBI9FQPC | ||||||
| Subjects: | 96 | ||||||
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| Clinical Assessments: | None | ||||||
| SDY660: LEAP ITN032AD: Induction of Tolerance through Early Introduction of Peanut in High-Risk Children, LEAP-On ITN049AD: The Persistence of Oral Tolerance Induction to Peanut and Its Immunological Basis | |||||||
| Status: | Updated | ||||||
| Description: | ITN032AD: Allergic reactions to peanuts are potentially life-threatening and, in some children, can result from ingestion of only trace quantities of peanuts. At highest risk are children with eczema or who are allergic to eggs; these children have a 20% chance of developing peanut allergy by the age of five. The majority of children allergic to peanuts have their first reaction between the ages of 14 and 24 months, often at the time of their first exposure to peanut. Currently, there is no cure for peanut allergy.Peanut allergy has become an increasingly common problem in early childhood in the United States and the United Kingdom. Despite current public health guidelines in both countries recommending the avoidance of peanut consumption in the first years of life, the proportion of children with peanut allergy doubled in these countries over the period from 1998 to 2003. In contrast, peanuts are commonly consumed by infants in relatively high amounts in Africa, Southeast Asia and Israel, yet the rate of peanut allergy is quite low and does not appear to be increasing. Peanut consumption by infants in these parts of the world may actually protect children from developing peanut allergy by promoting oral tolerance to peanuts.Participants in this study will be randomly assigned to either follow a peanut consumption regimen or a strict peanut avoidance regimen. Those assigned to the peanut consumption group will be asked to consume an age-appropriate snack three times a week for the duration of the study and will be monitored closely during their first introduction to peanut.Those assigned to the peanut avoidance group will be asked to avoid ingestion of peanut for the first three years of life. A physical exam, allergy testing, and other immune system tests requiring blood collection will occur at Years 1, 3, and 5 following study entry. During the study, parents will maintain regular contact with study dietitians. ITN049AD: This is a two-sample comparison employing all available study participants in both arms of the current LEAP study at V72. After obtaining informed consent LEAP participants who are evaluable for peanut allergy at age 60 months (V60) will be enrolled into the LEAP-On Study. All LEAP-On participants will avoid peanut for an additional 12 months regardless of their previous allocation to the LEAP Study consumption arm (Group A) or the LEAP Study avoidance arm (Group B). At V72, after 12 months of this new intervention, all participants will have skinprick testing, specific IgE and a repeat oral challenge to peanut to determine the frequency of peanut allergy in both groups. The LEAP Study decision table will be used to determine the presence of peanut allergy. Briefly, peanut allergy will be based on the presence of a positive oral peanut challenge with objective signs of allergy. Tolerance will be established on the basis of a negative oral peanut challenge (tolerating 5 g of peanut protein in the absence of symptoms). | ||||||
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| DOI: | 10.21430/M3SFPACKA3 | ||||||
| Subjects: | 640 | ||||||
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| Assays: | None | ||||||
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