Grant List
Represents Grant table in the DB
GET /v1/grants?page%5Bnumber%5D=1385&sort=keywords
{ "links": { "first": "https://cic-apps.datascience.columbia.edu/v1/grants?page%5Bnumber%5D=1&sort=keywords", "last": "https://cic-apps.datascience.columbia.edu/v1/grants?page%5Bnumber%5D=1405&sort=keywords", "next": "https://cic-apps.datascience.columbia.edu/v1/grants?page%5Bnumber%5D=1386&sort=keywords", "prev": "https://cic-apps.datascience.columbia.edu/v1/grants?page%5Bnumber%5D=1384&sort=keywords" }, "data": [ { "type": "Grant", "id": "6523", "attributes": { "award_id": "3R01MD011575-05S1", "title": "Social stressors and inflammation: A mixed methods approach to preterm birth", "funder": { "id": 4, "ror": "https://ror.org/01cwqze88", "name": "National Institutes of Health", "approved": true }, "funder_divisions": [ "National Institute on Minority Health and Health Disparities (NIMHD)" ], "program_reference_codes": [], "program_officials": [ { "id": 21858, "first_name": "Rina", "last_name": "Das", "orcid": null, "emails": "", "private_emails": "", "keywords": null, "approved": true, "websites": null, "desired_collaboration": null, "comments": null, "affiliations": [] } ], "start_date": "2017-01-06", "end_date": "2022-04-30", "award_amount": 197610, "principal_investigator": { "id": 21859, "first_name": "Carmen", "last_name": "Giurgescu", "orcid": null, "emails": "[email protected]", "private_emails": null, "keywords": "[]", "approved": true, "websites": "[]", "desired_collaboration": "", "comments": "", "affiliations": [ { "id": 1475, "ror": "https://ror.org/036nfer12", "name": "University of Central Florida", "address": "", "city": "", "state": "FL", "zip": "", "country": "United States", "approved": true } ] }, "other_investigators": [], "awardee_organization": { "id": 1475, "ror": "https://ror.org/036nfer12", "name": "University of Central Florida", "address": "", "city": "", "state": "FL", "zip": "", "country": "United States", "approved": true }, "abstract": "Black women are more likely to become ill with COVID-19 than Whites, with disparities reported in many cities including Detroit, one of our sites. Black women are overrepresented in the low-wage essential workforce and more likely to live in disadvantaged neighborhoods (e.g., crowded housing) facing challenges in social distancing. Blacks have less in the way of savings and possibly less flexible employers than Whites, increasing risks for economic hardship (e.g., loss of jobs). Black women may experience discrimination in obtaining testing and medical care for COVID-19 symptoms for themselves and their families. Due to “shelter in place” policy and job losses with the pandemic, Black women may also experience increased conflict with their partner and higher rates of intimate partner violence (IPV) due to families spending nearly all waking and sleeping time together. Racial disparities -- in COVID-19 prevalence and death rates, employment, neighborhood conditions, economic hardship, IPV, and discrimination in testing and medical care -- may all increase psychological distress (e.g., depressive symptoms) for Black women. However, no published research has examined Black women’s experiences during a viral pandemic such as we are now experiencing. We hypothesize that Black women will experience more discrimination, economic hardship, conflict with partner, IPV and psychological distress as well as lower levels of support during the pandemic than pre-pandemic. Our cohort is comprised of 658 Black women from the Detroit, MI and Columbus, OH metropolitan areas. As part of the R01 study, women completed questionnaires during their pregnancies (T1=pre-pandemic). For this supplemental study, women will complete an online survey (T2= during the pandemic) on a smart phone or another device. The T2 survey will include key domains from the T1 survey (e.g., depressive symptoms, social support, IPV) and provide a second critical time point in the context of the pandemic. We expect some domains to be especially impacted by the pandemic (e.g., discrimination, stress). We also added items to capture COVID-19 specific issues, including experiences within their network (e.g. family members sickened), as well as measures pertinent to the situation (e.g., social isolation). A subsample of women will participate in qualitative interviews for an in-depth understanding of their experiences. We aim to: (1) Examine associations of disadvantaged neighborhoods, racial discrimination and economic hardship with psychological distress at both time points (T1 and T2); (2) Examine whether relationship with the partner, IPV, and psychological distress are impacted by the pandemic by comparing the pre-pandemic and during pandemic time points; (3) Examine how social isolation and social support relate to relationship with the partner, IPV, and psychological distress during the pandemic; and (4) Explore pregnant women’s experiences during the COVID-19 pandemic through qualitative interviews. Black women are especially vulnerable during the pandemic. The time-sensitive nature of the COVID-19 pandemic demands the immediate exploration of women’s experiences.", "keywords": [ "Anxiety", "Area", "Birth", "Buffers", "COVID-19", "COVID-19 pandemic", "Caring", "Cellular Phone", "China", "Cities", "Communities", "Conflict (Psychology)", "Crowding", "Data", "Death Rate", "Devices", "Diagnosis", "Discrimination", "Disease", "Economics", "Employment", "Family", "Family member", "Fathers", "Food", "Friends", "High Prevalence", "Housing", "Hygiene", "Infection", "Inflammation", "Interview", "Italy", "Measures", "Medical", "Medical Records", "Methods", "Mothers", "Nature", "Neighborhoods", "Occupations", "Outcome", "Policies", "Postpartum Women", "Pregnancy", "Pregnant Women", "Premature Birth", "Prevalence", "Publishing", "Questionnaires", "Reporting", "Research", "Risk", "Risk Factors", "Savings", "Shelter facility", "Site", "Sleep", "Social Distance", "Social isolation", "Social support", "Stress", "Surveys", "Symptoms", "Testing", "Time", "Viral", "Wages", "Water", "Woman", "adverse birth outcomes", "cohort", "coping", "depressive symptoms", "experience", "flexibility", "intimate partner violence", "metropolitan", "neighborhood disadvantage", "pandemic disease", "perceived stress", "pregnant", "psychological distress", "racial discrimination", "racial disparity", "social stressor", "stress symptom" ], "approved": true } }, { "type": "Grant", "id": "9672", "attributes": { "award_id": "75N91019D00022-0-759102200001-1", "title": "BASE TITLE: PREVENT PRECLINICAL DRUG DEVELOPMENT PROGRAM: PRECLINICAL EFFICACY AND INTERMEDIATE ENDPOINT BIOMAKERSTASK ORDER TITLE: VACCINES AGAINS", "funder": { "id": 4, "ror": "https://ror.org/01cwqze88", "name": "National Institutes of Health", "approved": true }, "funder_divisions": [ "National Cancer Institute (NCI)" ], "program_reference_codes": [], "program_officials": [], "start_date": "2022-06-15", "end_date": "2023-12-14", "award_amount": 614163, "principal_investigator": { "id": 25494, "first_name": "MARGIE", "last_name": "CLAPPER", "orcid": null, "emails": "", "private_emails": "", "keywords": null, "approved": true, "websites": null, "desired_collaboration": null, "comments": null, "affiliations": [] }, "other_investigators": [], "awardee_organization": { "id": 750, "ror": "", "name": "RESEARCH INST OF FOX CHASE CAN CTR", "address": "", "city": "", "state": "PA", "zip": "", "country": "United States", "approved": true }, "abstract": "Colorectal cancer (CRC) is one of the leading causes of cancer-related mortality worldwide. In the Unites States, an estimated 151,300 Americans will be diagnosed with CRC and over 52,580 are expected to die from the disease in 2022 alone (https://seer.cancer.gov/statfacts/html/colorect.html). While the five-year survival rate for localized CRC is excellent at 90%, more than half of new CRC cases have the disease spread to regional lymph nodes and/or distant organs at the time of diagnosis. CRC with distant metastasis has a dismal five-year survival rate of 14.7%. These data clearly indicate that CRC-related mortality can be significantly improved if the disease is detected early and proper interventions could be deployed. Because CRC typically originates from precancerous colorectal polyps, routine colonoscopy screening provides an excellent opportunity to detect precursor or early lesions and reduce CRC-related morbidity and mortality. Indeed, the US Preventive Services Task Force recently updated its recommendation on CRC screening, noting the evidence that the screening in average-risk asymptomatic adults aged 50 to 75 years is of substantial benefit. Risk factors for CRC include age (>50), race (African American), obesity, cigarette smoking, type II diabetes, history of inflammatory bowel diseases, family history of colorectal polyps or CRC, and inherited genetic syndromes known to increase the CRC risks, such as familial adenomatous polyposis (FAP) and Lynch syndrome. FAP and Lynch syndrome are caused by germline mutations in the APC gene and DNA mismatch repair genes, respectively. The management of individuals with hereditary gastrointestinal cancer syndromes requires additional measures beyond what is recommended for the average-risk population to minimize the overall risk of cancer-associated morbidity and mortality. Management options for the confirmed mutation carriers include multiple aggressive screening, chemopreventive strategies, and prophylactic surgery. However, these interventions are associated with various degrees of adverse effects. Safer and more effective preventive measures are urgently needed for the individuals with FAP, Lynch syndrome, and other hereditary gastrointestinal cancer syndromes. Fusobacteria are common human oral gram-negative anaerobic microflora isolated from dental plaque and gum diseases, but rarely detectable in the colorectum of healthy individuals. In recent years, the enrichment of a specific pathotype, Fusobacterium nucleatum (Fn), has been demonstrated in the colonic tissues and stools from patients with colorectal adenomas and CRC. Clinical evidence suggests that the prevalence of Fn progressively increases from dysplasia, adenomas to CRC and the higher amount of Fn is significantly associated with CRC with high microsatellite instability, which is caused by DNA MMR deficiencies as seen in Lynch syndrome-associated CRC. The potential association of Fn with CRC tumorigenesis has been examined in a mouse model of FAP. ApcMin/+ mice, which carry a nonsense mutation at codon 850 of the Apc gene, had a significantly accelerated onset and increased multiplicity of both small intestinal and colorectal tumors after oral inoculation of Fn. These data strongly suggested the tumor-promoting role of Fn in ApcMin/+ mice. Interestingly, Fn did not induce colitis in these animals, in contrast to enterotoxigenic Bacteroides fragilis, which has been shown to cause colitis and accelerate tumorigenesis in ApcMin/+ mice. It has also been demonstrated that Fn promotes CRC, breast, and cervical cancer metastasis and can metastasizes with tumor cells. Although how Fn contributes to CRC tumorigenesis has yet to be fully elucidated, emerging evidence points to its virulence factors, such as FadA and Fap2, as potential enhancers of CRC tumorigenesis and progression. The Fap2 has been shown to bind to human T-cell immunoglobulin ITIM domain (TIGIT), an immunoglobulin superfamily receptor known to function as an immune co-inhibitory molecule. Fap2-binding to TIGIT on NK and other T cells protects tumor cells from NK cell-mediated cytotoxicity and blocks effector T cell functions in the tumor microenvironment. TIGIT has also been shown to promote Treg function. Taken together, Fn may exert tumor promoting effects not only by promoting CRC tumor growth, but also by exploiting the immune-suppressive function of TIGIT via its virulence factor protein and contributing to tumor immune evasion mechanisms. Cancers caused by infectious agents are theoretically preventable, if one can prevent the infection, eradicate oncogenic pathogens before tumor development, or suppress the functions of oncogenic molecules. Prophylactic vaccines for human papillomavirus and hepatitis B virus have been associated with significant reductions in infection rates, which are expected to result in the dramatic decrease in the incidence of cervical cancers and hepatocellular carcinoma, respectively. Compared to the prevention of infection, the eradication of oncogenic infectious agents already colonized in the host is in general highly challenging, if not impossible. For example, the well-established eradication regimens for Helicobacter pylori, which increases the risk of noncardia gastric cancers, do not eradicate the bacteria in all cases. Rather, emerging resistance to multiple antibiotics appears to be contributing to the recent decline in the eradication rate. Alternatively, the host immune defense system may be fortified by pathogen-targeted vaccines, if they can boost anti-pathogen immunity and lead to the containment of infection or suppression of pathogen-mediated tumorigenic functions. Fn is a gram-negative anaerobic bacillus, and can be isolated from 60-70% of children aged 5-7 years. As with other gram-negative bacteria, Fn produces outer membrane vesicles (OMVs), which contain much of the biological content of the Fn, but without replicative capacity and some of the soluble proteins found in OMVs may elicit anti-Fn immunity. As part of the PREVENT project to develop Fn OMV based anti-Fn vaccine (https://reporter.nih.gov/project-details/9358850), the proteomic characterization of Fn OMV led to the identification of putative immunogenic components, some of which may be useful as anti-Fn vaccine antigens. Lipid nanoparticle (LNP)-encapsulated mRNA vaccines against COVID-19 revolutionized the implementation of mRNA-based vaccinology. In addition to modifications of mRNA such as with pseudouridine incorporation to reduce innate immune responses and mRNA purification methodologies to remove contaminants, the development of biocompatible LNPs significantly boosted the advancement of COVID and other mRNA-based vaccines. LNP-RNA vaccine platform offers several advantages over conventional protein-based vaccination, including a rapid development, refined adjustment of antigenic epitopes, easier scale-up and timely deployment. The the current study aims to develop and evaluate the immunogenicity of soluble protein-based and LNP-RNA-based Fn vaccines and to determine anti-Fn activity and immunopreventive efficacy of Fn-associated CRC, using mouse models of FAP and Lynch syndrome.", "keywords": [ "APC gene", "Adult", "Adverse effects", "Advisory Committees", "African American", "Age", "American", "Anaerobic Bacteria", "Animals", "Antibiotics", "Antigens", "ApcMin/+ mice", "Bacillus", "Bacteria", "Bacteroides fragilis", "Binding", "Biological", "COVID-19", "Cancer Etiology", "Cell physiology", "Cell-Mediated Cytolysis", "Chemopreventive Agent", "Child", "Clinical", "Codon Nucleotides", "Colitis", "Colonoscopy", "Colorectal", "Colorectal Adenoma", "Colorectal Cancer", "Colorectal Neoplasms", "Colorectal Polyp", "Containment", "DNA", "Data", "Dental Plaque", "Development", "Diagnosis", "Disease", "Distant", "Distant Metastasis", "Dysplasia", "Encapsulated", "Enhancers", "Epitopes", "Familial Adenomatous Polyposis Syndrome", "Family history of", "Feces", "Fusobacteria", "Fusobacterium nucleatum", "Genetic", "Germ-Line Mutation", "Goals", "Gram-Negative Bacteria", "Helicobacter pylori", "Hepatitis B Virus", "Hereditary Nonpolyposis Colorectal Neoplasms", "Human", "Human Papilloma Virus Vaccine", "ITIM", "Immune", "Immune Sera", "Immunity", "Immunoglobulins", "Immunosuppression", "Incidence", "Individual", "Infection", "Infection prevention", "Infectious Agent", "Inflammatory Bowel Diseases", "Inherited", "Innate Immune Response", "Intervention", "Lead", "Lesion", "Malignant Neoplasms", "Malignant neoplasm of cervix uteri", "Malignant neoplasm of gastrointestinal tract", "Measures", "Mediating", "Membrane", "Messenger RNA", "Methodology", "Microsatellite Instability", "Mismatch Repair", "Mismatch Repair Deficiency", "Modeling", "Modification", "Morbidity - disease rate", "Natural Killer Cells", "Neoplasm Metastasis", "Non-Insulin-Dependent Diabetes Mellitus", "Nonsense Mutation", "Obesity", "Oncogenic", "Operative Surgical Procedures", "Oral", "Organ", "Patients", "Phase", "Population", "Preclinical Drug Development", "Prevalence", "Preventive", "Preventive measure", "Preventive service", "Preventive vaccine", "Primary carcinoma of the liver cells", "Program Development", "Proteins", "Proteomics", "Pseudouridine", "RNA", "RNA vaccine", "Race", "Recommendation", "Recording of previous events", "Regimen", "Regulatory T-Lymphocyte", "Reporter", "Resistance", "Risk", "Risk Factors", "Role", "Small Intestinal Neoplasm", "Survival Rate", "Syndrome", "System", "T-Lymphocyte", "Time", "Tissues", "Tumor Escape", "United States", "United States National Library of Med" ], "approved": true } }, { "type": "Grant", "id": "12075", "attributes": { "award_id": "1K08CA277011-01A1", "title": "Differential Wnt Dependencies in Colon Epithelium.", "funder": { "id": 4, "ror": "https://ror.org/01cwqze88", "name": "National Institutes of Health", "approved": true }, "funder_divisions": [ "National Cancer Institute (NCI)" ], "program_reference_codes": [], "program_officials": [ { "id": 27928, "first_name": "Susan E", "last_name": "Lim", "orcid": null, "emails": "", "private_emails": "", "keywords": null, "approved": true, "websites": null, "desired_collaboration": null, "comments": null, "affiliations": [] } ], "start_date": "2023-09-01", "end_date": "2028-08-31", "award_amount": 196204, "principal_investigator": { "id": 27929, "first_name": "GEORGE", "last_name": "ENG", "orcid": null, "emails": "", "private_emails": "", "keywords": null, "approved": true, "websites": null, "desired_collaboration": null, "comments": null, "affiliations": [] }, "other_investigators": [], "awardee_organization": { "id": 736, "ror": "https://ror.org/002pd6e78", "name": "Massachusetts General Hospital", "address": "", "city": "", "state": "MA", "zip": "", "country": "United States", "approved": true }, "abstract": "This proposal details a five-year training plan for the development of a research program focused on elucidating the therapeutic potential of superimposed additional Wnt signaling on colonic neoplasia. The molecular driver shared across the vast majority of colonic neoplasms is constitutive Wnt signaling, most commonly caused by loss of function mutations in the APC gene. The loss of function of APC permits beta catenin to constitutively translocate to the nucleus and induce the formation of colonic adenomas which can further mutate into colon cancer. To date, strategies to inhibit Wnt signaling for therapeutic purposes have failed. However, other elements of the beta catenin destruction complex that work with APC, such as GSK3 alpha and beta can be pharmacologically inhibited. Therefore, instead of inhibiting Wnt signaling, and informed by the concept that a “just right” amount of Wnt signaling may be selected for in tumor cells, we hypothesized additional Wnt signaling would be deleterious to tumor cells but would simultaneously enhance the function of normal cells. This project will elucidate fundamental dependencies of Wnt signaling in normal tissues as well as tumors. Ultimately, I believe this will engender a specific therapy for adenomas, to which there is no existing medical therapy other than polypectomy, and additionally provide a broadly applicable and potentially safe approach to treat colorectal cancer. I am clinically trained pathologist and physician scientist seeking K08 support for mentored research. This work will be mentored by Prof. Omer Yilmaz and Prof. Robert Langer. Prof. Yilmaz is a pathologist and physician-scientist, and studies the effects of diet on intestinal stem cells and state- of-the-art intestinal organoid models. Prof. Langer has fundamentally transformed and defined biomedical engineering, is the most cited engineer in history, and most recently his expertise in nanoparticle delivery provided the foundation for the Moderna COVID-19 vaccine. The work will be conducted at the Massachusetts Institute of Technology and Massachusetts General Hospital, both world class institutions of the highest caliber. I have assembled a scientific advisory committee consisting of world class cancer biologists to help guide my scientific progress, consisting of Prof. Tyler Jacks, Prof. Michael Yaffe, and Prof. William Kaelin. This K08 mentored research award will ensure I have the time and resources to develop expertise in cancer biology and explore this promising therapeutic and biologically intriguing concept of increased Wnt signaling to specifically treat colonic neoplasia. This topic will provide ample substrate for me to grow as an independent physician scientist.", "keywords": [ "APC gene", "APC mutation", "Adenocarcinoma", "Advisory Committees", "Affect", "Agonist", "Award", "Biological Assay", "Biomedical Engineering", "CRISPR interference", "Caliber", "Cancer Biology", "Cancer Model", "Carcinoma", "Cell Nucleus", "Cell Proliferation", "Cell physiology", "Cells", "Clinical", "Colon", "Colon Adenocarcinoma", "Colon Carcinoma", "Colonic Adenoma", "Colonic Neoplasms", "Colorectal Cancer", "Complex", "Data", "Dependence", "Development Plans", "Diet", "Dose", "Elements", "Engineering", "Ensure", "Epithelium", "Essential Genes", "Exhibits", "Foundations", "Frequencies", "General Hospitals", "Genes", "Genetic", "Glycogen Synthase Kinase 3", "Growth", "Human", "Institution", "Intestines", "KRAS2 gene", "Knock-out", "Lesion", "Location", "Loss of Heterozygosity", "Maintenance", "Malignant Neoplasms", "Massachusetts", "Medical", "Mentors", "Modeling", "Moderna COVID-19 vaccine", "Molecular", "Mus", "Mutate", "Mutation", "Normal Cell", "Normal tissue morphology", "Oncogenic", "Organoids", "Pathologist", "Pathway interactions", "Patients", "Physicians", "Polypectomy", "Pre-Clinical Model", "Protein Kinase", "Proteins", "Recording of previous events", "Research", "Resources", "Rho-associated kinase", "Scientist", "Signal Transduction", "Specimen", "Stereotyping", "TP53 gene", "Technology", "Therapeutic", "Time", "Toxic effect", "Training", "WNT Signaling Pathway", "Wnt proteins", "Work", "adenoma", "beta catenin", "clinical care", "colon cancer treatment", "human model", "improved", "in vivo", "inhibitor", "knock-down", "loss of function", "loss of function mutation", "mouse model", "mutant", "nanoparticle", "nanoparticle delivery", "neoplastic cell", "novel", "pharmacologic", "progenitor", "programs", "small molecule inhibitor", "stem cells", "success", "targeted treatment", "transcriptome sequencing", "transcriptomics", "tumor", "tumor growth" ], "approved": true } }, { "type": "Grant", "id": "9176", "attributes": { "award_id": "75N92020C00020-P00001-9999-1", "title": "RADX TECH - MAXIM BIOMEDICAL INC. SARS-COV-2 ANTIGEN RAPID TEST", "funder": { "id": 4, "ror": "https://ror.org/01cwqze88", "name": "National Institutes of Health", "approved": true }, "funder_divisions": [ "National Institute of Biomedical Imaging and Bioengineering (NIBIB)" ], "program_reference_codes": [], "program_officials": [], "start_date": "2020-08-28", "end_date": "2021-08-27", "award_amount": 3153450, "principal_investigator": { "id": 24936, "first_name": "JONATHAN", "last_name": "MAA", "orcid": null, "emails": "", "private_emails": "", "keywords": null, "approved": true, "websites": null, "desired_collaboration": null, "comments": null, "affiliations": [ { "id": 1805, "ror": "", "name": "MAXIM BIOMEDICAL, INC.", "address": "", "city": "", "state": "MD", "zip": "", "country": "United States", "approved": true } ] }, "other_investigators": [], "awardee_organization": { "id": 1805, "ror": "", "name": "MAXIM BIOMEDICAL, INC.", "address": "", "city": "", "state": "MD", "zip": "", "country": "United States", "approved": true }, "abstract": "Maxim Biomedical, Inc. (Maxim), headquartered in Maryland, USA, was formed in May 2005 to develop and provide high quality, in-vitro diagnostic (IVD) and Point-of-Care (POC) testing solutions. Our FDA cGMP approved and ISO13485:2016 certified facility is equipped with state-of-the-art laboratories for in-vitro diagnostic production. In response to the COVID-19 pandemic and in collaboration with the US Department of Defense (DoD), Maxim has in-house developed the Maxim SARS-CoV-2 Antigen Rapid Test Kit as a single-use qualitative lateral flow immunoassay to detect the circulating antigens of SARS-CoV-2. This point-of-care (POC) test is currently suitable for use with nasopharyngeal specimens from individuals suspected of COVID-19 infection and requires 10 minutes for a complete readout. A small-batch production (5000 units) of Maxim’s SARS-CoV-2 Antigen Rapid Test prototype has undergone and completed performance evaluation testing by the DoD’s Defense Biological Product Assurance Office (DBPAO) with highly promising results (see Prior Work). Optimizations are already ongoing to improve the sensitivity and specificity and to ensure that the product can be manufactured in a scalable manner. Maxim is currently seeking funding to rapidly scale up production capacity to be able to meet DoD’s demand of an estimated minimum of 1 MM tests/month by 07/15/20. Based on our current stage of development, we believe that Maxim’s Rapid Antigen Test can meet the milestones of this RADx program to rapidly deploy test kits to the general public.", "keywords": [ "Aphorisms", "Biological Products", "COVID-19 pandemic", "Collaborations", "Cyclic GMP", "Department of Defense", "Development", "Diagnostic Reagent Kits", "Ensure", "Funding", "General Population", "Immunoassay", "Individual", "Laboratories", "Lateral", "Maryland", "Performance", "Production", "RADx", "RADx Tech", "SARS-CoV-2 antigen", "SARS-CoV-2 infection", "Sensitivity and Specificity", "Specimen", "Testing", "Work", "antigen test", "base", "evaluation/testing", "improved", "in-vitro diagnostics", "point of care testing", "programs", "prototype", "rapid test", "response", "scale up" ], "approved": true } }, { "type": "Grant", "id": "14828", "attributes": { "award_id": "1K23DK139454-01", "title": "Structural Racism as a \"Third hit\" on kidney outcomes of Black individuals with APOL1 risk alleles", "funder": { "id": 4, "ror": "https://ror.org/01cwqze88", "name": "National Institutes of Health", "approved": true }, "funder_divisions": [ "National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)" ], "program_reference_codes": [], "program_officials": [ { "id": 31506, "first_name": "RAQUEL CHARLES", "last_name": "Greer", "orcid": null, "emails": "", "private_emails": "", "keywords": null, "approved": true, "websites": null, "desired_collaboration": null, "comments": null, "affiliations": [] } ], "start_date": "2024-05-23", "end_date": "2029-01-31", "award_amount": 194940, "principal_investigator": { "id": 31507, "first_name": "Dinushika", "last_name": "Mohottige", "orcid": null, "emails": "", "private_emails": "", "keywords": null, "approved": true, "websites": null, "desired_collaboration": null, "comments": null, "affiliations": [] }, "other_investigators": [], "awardee_organization": { "id": 625, "ror": "https://ror.org/04a9tmd77", "name": "Icahn School of Medicine at Mount Sinai", "address": "", "city": "", "state": "NY", "zip": "", "country": "United States", "approved": true }, "abstract": "Black individuals have for decades been disproportionately impacted by kidney failure and rapid progression of kidney disease when compared to their White counterparts. Black individuals with APOL1 high-risk alleles are particularly vulnerable to accelerated chronic kidney disease (CKD) progression and kidney failure. However, these high-risk genotypes only occur in about 12-14% of Black individuals, and they do not guarantee CKD progression or kidney failure. Other risk factors, such as hypertension, HIV, and COVID-19, are thought to confer additional second-hit risks. Structural racism (SR)—defined as discriminatory policies and practices promoted through reinforcing systems (e.g., housing, wealth, health care) –– is also widely understood to be a contributor to racial disparities in kidney health. I hypothesize that SR acts as a “third hit” which contributes to excess risk of adverse kidney health outcomes among Black individuals with APOL1 risk alleles. Through four complementary aims, I will characterize the effects of structural racism on kidney health among Black individuals with high-risk APOL1 alleles and design and test a patient-centered intervention to mitigate effects of SR on health outcomes. In Aim 1, I will engage a multidisciplinary stakeholder board to collaborate in the analysis and interpretation of mixed-methods studies in Aims 2 and 3, and in the design and evaluation of a patient-centered pilot intervention in Aim 4. In Aim 2, I will quantify the longitudinal effects of SR with poor kidney health leveraging 3 large APOL1-enriched cohort studies. In Aim 3, I will characterize the experiences of structural racism of Black patients with APOL1 who have CKD and their clinicians with SR in health settings and their communities using qualitative analyses (photovoice, focus groups, semi-structured interviews). In Aim 4, in collaboration with the stakeholder board, I will pilot a patient-centered, navigator-led intervention designed to mitigate the effects of structural racism on kidney health. Throughout the award period, I will pursue training in advanced epidemiologic and statistical science, including longitudinal analysis and multilevel modeling, and develop skills in patient-centered clinical trial design and execution. Training goals and research aims are aligned and integrated to support a holistic experience. The robust training and world-class mentorship supported by this award, and Mount Sinai's enriched training environment and extensive resources, will prepare me for a career as an independent investigator dedicated to mitigating the devastating impact of structural racism on kidney health and eliminating kidney health disparities.", "keywords": [ "APOL1 gene", "Acceleration", "Address", "Advocate", "Albuminuria", "Alleles", "Award", "Black Populations", "Black race", "COVID-19", "Caregivers", "Caring", "Chronic Kidney Failure", "Clinical", "Clinical Trials Design", "Cohort Studies", "Collaborations", "Communities", "Complex", "Cross-Sectional Studies", "Dedications", "Development", "Diabetes Mellitus", "Dimensions", "Disease Progression", "End stage renal failure", "Environment", "Epidemiology", "Equity", "Evaluation", "Focus Groups", "Foundations", "Funding", "Future", "Goals", "HIV", "Harm Reduction", "Health", "Healthcare", "Heart", "Housing", "Hypertension", "Individual", "Intervention", "Interview", "Kidney", "Kidney Diseases", "Kidney Failure", "Legal", "Link", "Lived experience", "Longitudinal Studies", "Measures", "Mentors", "Mentorship", "Methods", "Outcome", "Participant", "Patient Outcomes Assessments", "Patients", "Penetrance", "Persons", "Pharmacy facility", "Policies", "Pollution", "Poverty", "Prevalence", "Race", "Research", "Research Personnel", "Resources", "Risk", "Risk Factors", "Science", "Social Environment", "Structural Racism", "Structure", "System", "Techniques", "Testing", "Training", "Waiting Lists", "black patient", "career", "clinical risk", "cohort", "comorbidity", "design", "disorder risk", "experience", "feasibility testing", "health disparity", "high risk", "implementation intervention", "improved", "intervention mapping", "longitudinal analysis", "multidisciplinary", "multilevel analysis", "patient engagement", "patient oriented", "pilot test", "primary care clinician", "racial bias", "racial disparity", "recruit", "risk variant", "skills", "social", "therapy design" ], "approved": true } }, { "type": "Grant", "id": "12171", "attributes": { "award_id": "3U01HG007269-09S2", "title": "IGNITE Cost Extension - Admin Supplement", "funder": { "id": 4, "ror": "https://ror.org/01cwqze88", "name": "National Institutes of Health", "approved": true }, "funder_divisions": [ "National Human Genome Research Institute (NHGRI)" ], "program_reference_codes": [], "program_officials": [ { "id": 28037, "first_name": "simona", "last_name": "volpi", "orcid": null, "emails": "", "private_emails": "", "keywords": null, "approved": true, "websites": null, "desired_collaboration": null, "comments": null, "affiliations": [] } ], "start_date": "2023-08-01", "end_date": "2025-06-30", "award_amount": 1351790, "principal_investigator": { "id": 28038, "first_name": "Larisa Humma", "last_name": "Cavallari", "orcid": null, "emails": "", "private_emails": "", "keywords": null, "approved": true, "websites": null, "desired_collaboration": null, "comments": null, "affiliations": [] }, "other_investigators": [ { "id": 28039, "first_name": "JULIE A.", "last_name": "JOHNSON", "orcid": null, "emails": "", "private_emails": "", "keywords": null, "approved": true, "websites": null, "desired_collaboration": null, "comments": null, "affiliations": [] } ], "awardee_organization": { "id": 158, "ror": "https://ror.org/02y3ad647", "name": "University of Florida", "address": "", "city": "", "state": "FL", "zip": "", "country": "United States", "approved": true }, "abstract": "The current administrative supplement request is for a 24-month extension with funding to complete the ongoing IGNITE Network pragmatic clinical trials, GUARDD-US and ADOPT-PGx. The GUARDD-US and ADOPT-PGx, have been underway since July 2020 and February 2021, respectively. These trials will help determine the impact of implementing genetic testing on hypertension, depression, and pain therapies. GUARDD-US: Chronic kidney disease (CKD) is associated with hypertension. People with African ancestry (AAs) have the highest risk of CKD and kidney failure, the highest prevalence of hypertension, and the lowest rate of blood pressure (BP) control. While this disparity is in part due to social determinants, ancestry has biological underpinnings, and APOL1 high- risk genetic variants, exclusively found in AAs, increase kidney failure risk 10-fold. We propose a genotype- guided trial to determine the effect of early vs. delayed knowledge of a positive APOL1 genotyping result on 3- month systolic blood pressure (SBP). The clinical trial aims to recruit African Americans with hypertension, with or without CKD, randomized to immediate versus delayed return of APOL1 genetic testing. In those who are APOL1 negative, we will also conduct a pilot study to test the impact of pharmacogenetic (PGx) testing on SBP. ADOPT-PGx: Pain and depression are conditions that impact substantial proportions of the US population. The treatment of acute and chronic pain is challenged by the difficulty of finding effective therapies while minimizing the risk of adverse effects or opioid addiction. For depression, there are few clinically relevant predictors of successful treatment, which results in inadequate therapy for many patients. We propose a prospective randomized pragmatic genotype-guided clinical trial that tests the effect of genotype-guided therapy in three scenarios of patients: acute post-surgical pain, chronic pain, and depression. For each scenario participants will be randomized to genotype-guided drug therapy versus usual approaches to drug therapy selection. Changes in patient-reported outcomes representing pain and depression control using standard PROMIS scales define the primary endpoints. Secondary analyses include safety endpoints, changes in overall well-being, and economic impact represented by differences in healthcare utilization. A 24-month extension with funding is needed due to unanticipated network-wide delays in launching each trial and shutdowns due to COVID-19. The funding requested in this administrative supplement reflects the trial needs as well as enrollment of 50 additional participants for the Depression Trial to address recruitment shortfalls by other groups and for the costs associated with leading analyses and publication costs for 15 secondary manuscripts.", "keywords": [ "APOL1 gene", "Acute", "Acute Pain", "Address", "Administrative Supplement", "Adult", "Adverse effects", "African American population", "African ancestry", "Antidepressive Agents", "Biological", "Blood Pressure", "COVID-19", "Chronic Kidney Failure", "Clinical", "Clinical Trials", "Data", "Disparity", "Dose", "Effectiveness", "Enrollment", "Ethnic Origin", "Florida", "Funding", "Future", "Genomic medicine", "Genomics", "Genotype", "Guidelines", "Health", "Healthcare", "High Prevalence", "Hypertension", "Kidney Failure", "Knowledge", "Manuscripts", "Mental Depression", "Opiate Addiction", "Opioid", "Outcome", "Pain", "Pain management", "Participant", "Patient Outcomes Assessments", "Patients", "Personal Satisfaction", "Persons", "Pharmaceutical Preparations", "Pharmacogenetics", "Pharmacogenomics", "Pharmacotherapy", "Pilot Projects", "Population", "Population Heterogeneity", "Postoperative Pain", "Pragmatic clinical trial", "Provider", "Publications", "Race", "Randomized", "Risk", "Safety", "Selection for Treatments", "Site", "Test Result", "Testing", "Time", "Universities", "Vulnerable Populations", "blood pressure control", "chronic pain", "clinically relevant", "comparison control", "cost", "demographics", "depressive symptoms", "economic impact", "effective therapy", "genetic testing", "genetic variant", "health care service utilization", "health difference", "health disparity", "high risk", "hypertension control", "hypertensive", "improved", "opioid therapy", "participant enrollment", "patient population", "pharmacogenetic testing", "primary endpoint", "primary outcome", "prospective", "recruit", "risk minimization", "secondary analysis", "social determinants", "treatment arm", "treatment as usual" ], "approved": true } }, { "type": "Grant", "id": "8594", "attributes": { "award_id": "1R01HL159370-01", "title": "Sympathetic-Vascular Dysfunction in Obesity-Related Hypertension", "funder": { "id": 4, "ror": "https://ror.org/01cwqze88", "name": "National Institutes of Health", "approved": true }, "funder_divisions": [ "National Heart Lung and Blood Institute (NHLBI)" ], "program_reference_codes": [], "program_officials": [ { "id": 24365, "first_name": "Cheryl", "last_name": "McDonald", "orcid": null, "emails": "", "private_emails": "", "keywords": null, "approved": true, "websites": null, "desired_collaboration": null, "comments": null, "affiliations": [] } ], "start_date": "2021-08-01", "end_date": "2026-07-31", "award_amount": 460624, "principal_investigator": { "id": 24366, "first_name": "SETH WILLIAM", "last_name": "HOLWERDA", "orcid": null, "emails": "", "private_emails": "", "keywords": null, "approved": true, "websites": null, "desired_collaboration": null, "comments": null, "affiliations": [ { "id": 875, "ror": "https://ror.org/036c9yv20", "name": "University of Kansas Medical Center", "address": "", "city": "", "state": "KS", "zip": "", "country": "United States", "approved": true } ] }, "other_investigators": [], "awardee_organization": { "id": 875, "ror": "https://ror.org/036c9yv20", "name": "University of Kansas Medical Center", "address": "", "city": "", "state": "KS", "zip": "", "country": "United States", "approved": true }, "abstract": "Obesity is highly prevalent in the U.S. and has significant consequences for mortality and quality of life. Obesity is the primary gateway to additional cardiovascular disease (CVD) risk factors such as increased insulin resistance, dyslipidemia, and hypertension. Prospective studies have estimated that nearly 75% of cases of hypertension can be attributed to obesity. Hallmarks of obesity-related hypertension are oxidative stress, chronic inflammation, and vascular dysfunction. However, our understanding of the precise mechanisms underlying the development of hypertension in obesity and insulin resistance remains incomplete. We hypothesize that hyperglycemia and hyperlipidemia augment vascular sensitivity to single bursts of sympathetic nerve activity (SNA) via oxidative stress to heighten blood pressure variability in obesity and insulin resistance. Using a double- blinded, placebo-controlled, randomized approach, we will determine the extent to which sympathetic-vascular transduction is elevated by hyperglycemia and hyperlipidemia and resultant oxidative stress and the extent to which suppression of oxidative stress via ascorbic acid attenuates the exaggerated increase in vascular sensitivity to single bursts of SNA. Given our innovative approach, these studies provide direct insight into the ability of single bursts of SNA to dynamically regulate vascular tone and blood pressure. We will also test the novel hypothesis that sympathetic blockade mitigates the pro-inflammatory phenotype of obesity. Obesity is also characterized by chronic inflammation, which is mediated in part by the sympathetic nervous system. Expression of pro-inflammatory cytokines such as tumor necrosis factor alpha (TNF-α) can be regulated by norepinephrine. The urgency to mitigate inflammation in obesity has recently been accelerated by the increased risk of poor outcomes following infection by SARS-CoV-2. Indeed, recent data show that circulating concentrations of pro- inflammatory cytokines such as interleukin 6 (IL-6) are positively correlated with poor outcomes in patients with SARS-CoV-2. We propose sympathetic blockade as a novel approach to mitigating the pro-inflammatory phenotype of obesity and hypertension. To demonstrate feasibility of our hypothesis, we have performed pilot studies using a randomized, double-blinded, parallel study design in a small group of overweight/obese adults using 4 weeks of oral clonidine to reduce central sympathetic outflow and observed significant reductions in MSNA and circulating TNF-α but no change in MSNA and circulating TNF-α following 4 weeks of placebo or hydrochlorothiazide (HCTZ) as a BP-lowering control condition. We plan to extend these preliminary data in our outlined studies to achieve sufficient power to observe signficant and clinically meaningful group differences in circulating and endothelial cell pro-inflammatory cytokines. The long-term goal of our research is to identify unique mechanisms that can be targeted to limit increases in vascular dysfunction in obesity and insulin resistance and reduce the excessively high prevalence of hypertension and risk for CVD.", "keywords": [ "Apoptosis", "Ascorbic Acid", "Attenuated", "Blood Pressure", "Blood Vessels", "COVID-19 patient", "Cardiovascular Diseases", "Chronic", "Clinical", "Clinical Research", "Clonidine", "Data", "Development", "Diuretics", "Double-Blind Method", "Dyslipidemias", "Endothelial Cells", "Glucose", "Goals", "High Prevalence", "Human", "Hydrochlorothiazide", "Hyperglycemia", "Hyperinsulinism", "Hyperlipidemia", "Hypertension", "Impairment", "Individual", "Inflammation", "Inflammatory", "Infusion procedures", "Insulin", "Insulin Resistance", "Interleukin-6", "Intravenous infusion procedures", "Lipids", "Measures", "Mediating", "Muscle", "Nerve", "Norepinephrine", "Obesity", "Obesity Related Hypertension", "Oral", "Outcome", "Overweight", "Oxidative Stress", "Participant", "Pharmacology", "Phenotype", "Pilot Projects", "Placebos", "Play", "Population", "Prospective Studies", "Quality of life", "Randomized", "Reactive Oxygen Species", "Research", "Research Design", "Resolution", "Risk", "Risk Factors", "Role", "SARS-CoV-2 infection", "Serum", "Smooth Muscle Myocytes", "Source", "Sympathetic Nervous System", "TNF gene", "Testing", "Thinness", "Vascular Diseases", "Vascular Proliferation", "Vascular Smooth Muscle", "adult obesity", "blood pressure variability", "cardiovascular disorder risk", "cytokine", "design", "effective therapy", "glucose uptake", "inflammatory marker", "innovation", "insight", "macrophage", "mortality", "novel", "novel strategies", "novel therapeutic intervention", "obesity development", "response", "translational study", "vasoconstriction" ], "approved": true } }, { "type": "Grant", "id": "7717", "attributes": { "award_id": "1ZIAAG000778-04", "title": "The role of immune cells in Alzheimer's disease", "funder": { "id": 4, "ror": "https://ror.org/01cwqze88", "name": "National Institutes of Health", "approved": true }, "funder_divisions": [ "National Institute on Aging (NIA)" ], "program_reference_codes": [], "program_officials": [], "start_date": null, "end_date": null, "award_amount": 528921, "principal_investigator": { "id": 23510, "first_name": "Arya", "last_name": "Biragyn", "orcid": null, "emails": "", "private_emails": "", "keywords": null, "approved": true, "websites": null, "desired_collaboration": null, "comments": null, "affiliations": [ { "id": 1613, "ror": "https://ror.org/049v75w11", "name": "National Institute on Aging", "address": "", "city": "", "state": "MD", "zip": "", "country": "United States", "approved": true } ] }, "other_investigators": [], "awardee_organization": { "id": 1613, "ror": "https://ror.org/049v75w11", "name": "National Institute on Aging", "address": "", "city": "", "state": "MD", "zip": "", "country": "United States", "approved": true }, "abstract": "The role of B cells in Alzheimer's disease (AD) remains poorly understood even though we and others showed their benefit as producers of antibody that help to eliminate neurotoxic beta-amyloid depositions (Ab plaques) (Olkhanud et al, Vaccine, 2011). About 6 years ago, we have hypothesized that B cells could also be promoting AD because they upregulate expression of inflammatory factors together with the onset of AD in 3xTgAD mice. We tested this possibility in 3 different mouse models of AD, such as 3xTgAD, APP/PS1 and 5xFAD mice, utilizing complementing experimental strategies. First, we generated B-cell deficient (BKO) mice that develop AD in young and old age, 2xTgAD and 3xTgAD mice by crossing BKO mice with 2xTgAD and 3xTgAD mice, respectively. The loss of B cells in these mice almost completely reversed the AD symptoms despite expression of AD-promoting transgenes. Compared to age/sex-matched B-cell sufficient littermates, 2xTgAD/BKO and 3xTgAD/BKO mice exhibited reduced anxiety and improved memory deficits. Both 2xTgAD/BKO and 3xTgAD/BKO mice contained significantly fewer Ab-plaques in the brain subiculum than their age- and sex-matched littermates. The over activated microglia, another hallmark of AD pathology, in both mice without B cells was also markedly reduced. To confirm this finding, we also transiently depleted B cells from the circulation of mice with AD, such as 3xTgAD, APP/PS1 and 5xFAD mice, by injecting CD20-targeting antibody. The B-cell depletion indeed significantly delayed AD symptoms in all three types of mice. Overall, for the first time we demonstrate that B cells play pathogenic role in AD and, importantly, their transient depletion from the circulation can delay AD onset. The paper, which we recently submitted for publication, came back for revision. Due to the COVID-19 quarantine, we had to terminate experiments and cull essential AD mice, precluding a proper addressing the editor and reviewers comments. We therefore expect to finalize this paper by middle of 2021. Despite this, we have played the key roles in successful completion of 2 papers from our collaborators on Ad and AD-like symptoms in Down syndrome.", "keywords": [ "APP-PS1", "Address", "Age", "Aging", "Alzheimer&apos", "s Disease", "Alzheimer&apos", "s disease model", "Alzheimer&apos", "s disease pathology", "Antibodies", "Anxiety", "B-Lymphocytes", "Back", "Blood Circulation", "Brain", "COVID-19", "Cells", "Complement", "Disease", "Down Syndrome", "Exhibits", "Goals", "Immune", "Inflammatory", "MS4A1 gene", "Memory impairment", "Microglia", "Mus", "Onset of illness", "Paper", "Pathogenicity", "Play", "Publications", "Published Comment", "Quarantine", "Role", "Symptoms", "Testing", "Therapeutic", "Time", "Transgenes", "Vaccines", "abeta deposition", "experimental study", "improved", "mouse model", "neurotoxic", "sex" ], "approved": true } }, { "type": "Grant", "id": "9075", "attributes": { "award_id": "75N92020P00146-P00012-0-1", "title": "TO MODIFY THE CONTRACT AND ADD ADDITIONAL FUNDING TO CONFIGURE A SMARTPHONE AND WEB-BASED DIGITAL HEALTH SOLUTION TO SUPPORT THE GENERAL PUBLIC USE OF", "funder": { "id": 4, "ror": "https://ror.org/01cwqze88", "name": "National Institutes of Health", "approved": true }, "funder_divisions": [ "NIH Office of the Director" ], "program_reference_codes": [], "program_officials": [], "start_date": "2020-06-08", "end_date": "2022-06-07", "award_amount": 2358083, "principal_investigator": { "id": 24877, "first_name": "VIK", "last_name": "KHETERPAL", "orcid": null, "emails": "", "private_emails": "", "keywords": null, "approved": true, "websites": null, "desired_collaboration": null, "comments": null, "affiliations": [ { "id": 1793, "ror": "", "name": "CAREEVOLUTION, INC.", "address": "", "city": "", "state": "MI", "zip": "", "country": "United States", "approved": true } ] }, "other_investigators": [], "awardee_organization": { "id": 1793, "ror": "", "name": "CAREEVOLUTION, INC.", "address": "", "city": "", "state": "MI", "zip": "", "country": "United States", "approved": true }, "abstract": "The National Institute of Biomedical Imaging and Bioengineering (NIBIB) requires a system that can be managed by a study team and that will support general public use of SARS-CoV-2 diagnostic tests performed in a home setting. The platform must be easily accessible on a mobile device, support a variety of surveys, display test-specific usage instructions, provide guidance to the user on actions to take following test results, provide reminder notifications for test frequency, record the test results, integrate with technologies that provide test interpretation (as available), and report results to public health authorities as applicable and authorized by the user. It must additionally make all these data available to the study team for future analysis, when this is within the remit of the IRB approval for the study.", "keywords": [ "Apple", "COVID-19 diagnostic", "Cellular Phone", "Clinical Trials", "Communication", "Communities", "Contractor", "Contracts", "Custom", "Data", "Data Collection", "Data Storage and Retrieval", "Diagnostic tests", "Enrollment", "Ensure", "Event", "Feedback", "Focus Groups", "Frequencies", "Funding", "Future", "General Population", "Health Services Accessibility", "Home", "Individual", "Institutional Review Boards", "Instruction", "Internet", "Language", "Manuals", "Market Research", "National Institute of Biomedical Imaging and Bioengineering", "Notification", "Observational Study", "Online Systems", "Participant", "Personal Health Records", "Play", "Privacy", "Public Health", "Reaction", "Readability", "Reporting", "Secure", "Specific qualifier value", "Surveys", "Symptoms", "System", "Technology", "Test Result", "Testing", "Time", "Vaccination", "authority", "base", "diaries", "digital", "digital health", "handheld mobile device", "home test", "repository" ], "approved": true } }, { "type": "Grant", "id": "9076", "attributes": { "award_id": "75N92020P00146-P00005-0-1", "title": "TO MODIFY THE CONTRACT AND ADD ADDITIONAL FUNDING TO CONFIGURE A SMARTPHONE AND WEB-BASED DIGITAL HEALTH SOLUTION TO SUPPORT THE GENERAL PUBLIC USE OF", "funder": { "id": 4, "ror": "https://ror.org/01cwqze88", "name": "National Institutes of Health", "approved": true }, "funder_divisions": [ "National Institute of Biomedical Imaging and Bioengineering (NIBIB)", "NIH Office of the Director" ], "program_reference_codes": [], "program_officials": [], "start_date": "2020-06-08", "end_date": "2021-02-15", "award_amount": 4272000, "principal_investigator": { "id": 24877, "first_name": "VIK", "last_name": "KHETERPAL", "orcid": null, "emails": "", "private_emails": "", "keywords": null, "approved": true, "websites": null, "desired_collaboration": null, "comments": null, "affiliations": [ { "id": 1793, "ror": "", "name": "CAREEVOLUTION, INC.", "address": "", "city": "", "state": "MI", "zip": "", "country": "United States", "approved": true } ] }, "other_investigators": [], "awardee_organization": { "id": 1793, "ror": "", "name": "CAREEVOLUTION, INC.", "address": "", "city": "", "state": "MI", "zip": "", "country": "United States", "approved": true }, "abstract": "The National Institute of Biomedical Imaging and Bioengineering (NIBIB) requires a system that can be managed by a study team and that will support general public use of SARS-CoV-2 diagnostic tests performed in a home setting. The platform must be easily accessible on a mobile device, support a variety of surveys, display test-specific usage instructions, provide guidance to the user on actions to take following test results, provide reminder notifications for test frequency, record the test results, integrate with technologies that provide test interpretation (as available), and report results to public health authorities as applicable and authorized by the user. It must additionally make all these data available to the study team for future analysis, when this is within the remit of the IRB approval for the study.", "keywords": [ "Apple", "COVID-19 diagnostic", "Cellular Phone", "Clinical Trials", "Communication", "Communities", "Contractor", "Contracts", "Custom", "Data", "Data Collection", "Data Storage and Retrieval", "Diagnostic tests", "Enrollment", "Ensure", "Event", "Feedback", "Focus Groups", "Frequencies", "Funding", "Future", "General Population", "Health Services Accessibility", "Home", "Individual", "Institutional Review Boards", "Instruction", "Internet", "Language", "Manuals", "Market Research", "National Institute of Biomedical Imaging and Bioengineering", "Notification", "Observational Study", "Online Systems", "Participant", "Personal Health Records", "Play", "Privacy", "Public Health", "Reaction", "Readability", "Reporting", "Secure", "Specific qualifier value", "Surveys", "Symptoms", "System", "Technology", "Test Result", "Testing", "Time", "Vaccination", "authority", "base", "diaries", "digital", "digital health", "handheld mobile device", "home test", "repository" ], "approved": true } } ], "meta": { "pagination": { "page": 1385, "pages": 1405, "count": 14046 } } }