Grant List
Represents Grant table in the DB
GET /v1/grants?page%5Bnumber%5D=2&sort=-awardee_organization
{ "links": { "first": "https://cic-apps.datascience.columbia.edu/v1/grants?page%5Bnumber%5D=1&sort=-awardee_organization", "last": "https://cic-apps.datascience.columbia.edu/v1/grants?page%5Bnumber%5D=1392&sort=-awardee_organization", "next": "https://cic-apps.datascience.columbia.edu/v1/grants?page%5Bnumber%5D=3&sort=-awardee_organization", "prev": "https://cic-apps.datascience.columbia.edu/v1/grants?page%5Bnumber%5D=1&sort=-awardee_organization" }, "data": [ { "type": "Grant", "id": "15440", "attributes": { "award_id": "3R01MD019027-02S1", "title": "Factors Influencing Pediatric Asthma into Adulthood (FIPA2)", "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": 27240, "first_name": "UTIBE RONALD", "last_name": "Bickham-Wright", "orcid": null, "emails": "", "private_emails": "", "keywords": null, "approved": true, "websites": null, "desired_collaboration": null, "comments": null, "affiliations": [] } ], "start_date": "2023-09-25", "end_date": "2028-04-30", "award_amount": 120454, "principal_investigator": { "id": 32035, "first_name": "LYLE G", "last_name": "BEST", "orcid": null, "emails": "", "private_emails": "", "keywords": null, "approved": true, "websites": null, "desired_collaboration": null, "comments": null, "affiliations": [] }, "other_investigators": [ { "id": 9754, "first_name": "Esther", "last_name": "Erdei", "orcid": null, "emails": "", "private_emails": "", "keywords": null, "approved": true, "websites": null, "desired_collaboration": null, "comments": null, "affiliations": [ { "id": 761, "ror": "", "name": "UNIVERSITY OF NEW MEXICO HEALTH SCIS CTR", "address": "", "city": "", "state": "NM", "zip": "", "country": "United States", "approved": true } ] }, { "id": 32036, "first_name": "Dara", "last_name": "Torgerson", "orcid": null, "emails": "", "private_emails": "", "keywords": null, "approved": true, "websites": null, "desired_collaboration": null, "comments": null, "affiliations": [] } ], "awardee_organization": { "id": 2543, "ror": "", "name": "MISSOURI BREAKS RESEARCH, INC.", "address": "", "city": "", "state": "SD", "zip": "", "country": "United States", "approved": true }, "abstract": "A. Summary of Funded Parent Grant: Factors Influencing Pediatric Asthma into Adulthood (R01MD019027) The prevalence of asthma among American Indian (AI) children is 9.3% as compared to 5.5% in non- Hispanic White children. Asthma disparities become even more pronounced into adulthood, with AI adults having the highest prevalence of asthma as compared to all other racial/ethnic groups in the US, with 60% uncontrolled. Asthma is influenced by social and environmental factors (SEF) including adverse childhood events (ACEs), tobacco smoke, and everyday life stressors that may alter immunological state. ACEs in particular, including abuse, neglect, and household challenges have been associated with immune dysregulation, may have implications for clinical outcomes of respiratory viral infections in children that have been linked to asthma and persistent respiratory symptoms. For example, Infants who develop severe RSV bronchiolitis in the first year of life are more likely to develop asthma, and children with asthma are at increased risk of experiencing complications from respiratory viral infections due to SARS-CoV-2, respiratory syncytial virus (RSV), influenza, and rhinovirus C. In the Factors Influencing Pediatric Asthma (FIPA) study including children from a Northern Plains American Indian community, we found children with asthma experienced an increased clinical burden from RSV infection and had lower levels of serum RSV-specific Immunoglobulin G (IgG) than children without asthma, indicative of immune suppression or dysfunction. However, the complex interplay between social, environmental and immunological response to viral respiratory infections remains largely unknown, and these factors have not been investigated among AI children with respect to their influence on immunological response and asthma development and control of asthma symptoms. In this continued AI community-focused study, we will test the hypothesis that social and environmental factors contribute to asthma susceptibility through stress-induced immune dysregulation, including the alteration of immunological response to viral respiratory infections. We will also investigate the role of viral respiratory infections and SEF on asthma control, including frequency of symptoms, exacerbations, ER visits/hospitalizations, and use of asthma medications. Aim 1: Identify social and environmental factors (SEF) that contribute to asthma susceptibility, asthma control, and long-term respiratory health in American Indian children. We will follow-up on our previously NIMHD-funded case/control study of 324 children recruited between the ages of 6-17 from 2013- 2017 as they transition into adulthood (now ages 11-27). We will recontact original study participants, evaluating their current asthma status to investigate the role of age and gender on long-term respiratory health including current asthma and asthma control. We will also expand our study to 400 new participants with and without asthma between the ages of 6-17, including Tribal members living in Rapid City, SD, and offspring of original study participants (~30% of original study participants have since become parents). We will obtain detailed measures of SEF, and retrospective information on adverse childhood events (ACE) using an established screener to evaluate their role in asthma susceptibility and asthma control, including comparisons between urban vs. rural and multi-generational effects in this community-engaged study. We hypothesize that domains of biological and behavioral influences acting on the individual and interpersonal levels generate social stress and have an impact on asthma development and control. Aim 2: Investigate the role of SEF on immunological response to viral respiratory infections (VRIs) in AI children with and without asthma. We will investigate the impact of social and environmental factors measured using validated and Tribally-developed surveys on the immune system of AI children with and without asthma, including response to viral respiratory infections (viral-specific serum IgG and IgM concentrations to RSV and other VRI pathogens known to cause long-term respiratory sequelae). We will quantify serological measurements of participants’ humoral immune responses including serum biomarkers of inflammation (Th1/Th2/Th17 cytokines), atopy (serum total IgE), and total immunoglobulins. We will test our hypothesis that interactions with detailed survey measures of SEF with immunological and clinical outcomes of VRIs, including viral responses in participants with and without asthma are the strongest and most significant predictors in our AI participants. Aim 3: Engage with an existing Tribal Community Advisory Board (CAB) using continuous bidirectional process evaluation to develop an intervention and policy framework of asthma prevention. We will engage with the CRST’s dedicated community and Tribal cultural experts and active volunteers in building our local CAB. We will leverage the scientific knowledge gained under this proposal to work with the CAB to create a sustainable, feasible, and Lakota-driven, intervention and policy framework, including the creation of structures to allow integration of social stressers including ACEs into existing referral services and policy initiatives. We will collect detailed information using questionnaires and semi-structured interviews among CAB members and the community about the study development and processes. We recognize that Tribal children with mild, moderate to severe asthma who are experiencing humoral immune response alterations and a combination of SEFs need very targeted and specialized preventive measures that this study will be able to develop and support with implementation. B. RESEARCH PLAN: Environmental Toxicants and Asthma in American Indian Children Background: Viral respiratory infections in early life have been linked to the development of asthma and persistent respiratory symptoms in children 1–3, including respiratory syncytial virus (RSV) of which the majority of children are exposed before age 2. Infants who develop RSV bronchiolitis in the first year of life have a high chance of developing asthma 4, and children with asthma have an increased risk of experiencing complications and lasting respiratory symptoms from infections such as RSV, SARS-CoV-2, influenza, and rhinovirus-C 5–8. The prevalence of asthma among American Indian (AI) children is 9.3% as compared to 5.5% in non-Hispanic White children 9. This is a serious but understudied, pediatric health disparity in the U.S. that becomes even more pronounced into adulthood, with AI adults having the highest prevalence of asthma as compared to all other racial/ethnic groups 9. Asthma has been linked to a number of social and environmental factors 10–15 including exposure to social stress, tobacco smoke, air pollution, and environmental toxicants including per- and perfluoroalkyl substances (PFAS) 16. There is mounting evidence that PFAS, a “forever chemical” in the environment has a deleterious effect on many aspects of health 17, including thyroid and immune activity 18, inflammation in pregnancy 19, fetal growth 20, immune response to childhood vaccines 21 and viral respiratory infections 22,23. Thus, exposure to PFAS and environmental toxins during childhood may have a lasting effect on Tribal health. In summary, we propose to address newly emerging chemical exposures including PFAS in an at-risk, low income, Native American community in consultation with the Cheyenne River Sioux Tribe (CRST), including children living in Rapid City South Dakota and the Cheyenne River Sioux and Oglala Lakota Reservations. In this area of South Dakota, the proportion of children living below the Federal poverty line is 47% and 57% in Ziebach 24 and Dewey 25 Counties, respectively. The adverse health effects of PFAS and environmental toxins due to community-level exposure in this area of high childhood poverty has yet to be investigated, nor their effects on immunological response to viral respiratory infections and immune dysfunction. Preliminary Research: In the Factors Influencing Pediatric Asthma (FIPA) study we found that AI children with asthma living on the Cheyenne River Sioux and Oglala Lakota Reservations were more likely to reside in multi-unit housing, and in residences with rodent or insect infestation resulting in poor indoor air quality as compared to asthma controls 26. Children with asthma also had higher BMI, total leukocyte counts, % eosinophils, total serum IgE, and specific IgE to five common indoor airborne antigens 27. We also found children with asthma to have lower levels of RSV-specific IgG during the winter (Figure 1) and to report increased hospitalizations and RSV diagnoses (Figure 2), suggesting immune dysregulation with clinical implications 28. We hypothesize that exposures to environmental toxins, some of which have been linked to immune dysregulation may play an important role. Figure 1: A. Asthma cases recruited during the winter (RSV season) had significantly lower RSV IgG as compared to asthma cases recruited during the summer (p=2.5x10-6). There was no observed difference in seasonality for asthma controls (p=0.60). B. More children with asthma have low levels of IgG (<40 IU/mL). In unpublished results, Dr. Erdei (co-PI of parent study) detected PFAS in 83% of samples from 50 CRST adults who fish regularly from the Tribe's main public water sources. She has identified an association between PFAS and a number of tissue- specific and antinuclear autoantibodies, and found serum PFAS and other compounds to be predictors of autoimmune markers indicative of a hyperreactive immune response in adults (Figure 3). Consuming locally caught fish as part of AI Figure 2: Children with asthma in the FIPA study report a higher culture and as a dietary source of protein was also clinical burden from RSV. associated with overall elevation of serum PFAS. Similar investigations among children in the CRST will allow us to learn more about PFAS exposure patterns as it relates to immune dysregulation, viral respiratory infections, and its effect on children’s health in the community. Figure 3: Quantile Regression plots in CRST adults showing that A. Perfluorononanoic acid (PFNA) exposures are predictive of anti- native DNA response. B. PFOS and C. PFOA exposures are predictive of thyroid-specific (anti-thyroglobulin) autoimmune response, with PFOA having an immunosuppressive effect. In summary, we hypothesize that exposure to environmental toxins, specifically PFAS, contributes to immune dysregulation and response to viral respiratory infections in American Indian children with asthma. As recruitment for FIPA2 is starting, this is an opportune time for Dr. Spear to lead a study investigating the role of PFAS and environmental toxins on the health of AI children. This opportunity will afford Dr. Spear to narrow in on the role of PFAS on immune dysregulation and response to viral respiratory infections in children with and without asthma, while making new connections with scientists in the field of environmental research. Overall, our study will advance knowledge of the effect of environmental toxins on immune dysregulation of children to inform future policies and interventions. Thus, our specific aims for this diversity supplement are: Specific Aim 1: Measure and identify suspect and PFAS chemicals that are present in American Indian children from Rapid City and the Cheyenne River Sioux/Oglala Lakota Reservations. Specific Aim 2: Perform correlative and predictive modeling between PFAS/suspect chemicals and immunological biomarkers and response to viral respiratory infections in AI children with and without asthma. Approach: We will perform suspect screening and test for levels of 12 PFAS in serum samples of 52 children with and without asthma and living in urban vs. rural (Reservation) locations (Figure 4). We will identify suspect chemicals present in AI children, and perform preliminary correlations with immune biomarkers, viral-specific immunoglobulins, PFAS and suspect chemicals identified. Characterizing the presence and effect of environmental toxins on the immune system is an essential step for understanding environmental health disparities, which the community has been struggling with for decades. Figure 4: Location and summary of serum samples for study to measure PFAS/suspect chemicals in children ages 6-17 years old in FIPA2. Recruitment is beginning 5/2024. We also have stored samples for >300 original FIPA participants at -80C (living on Reservation, only). Specific Aim 1: Measure and identify suspect and PFAS chemicals that are present in American Indian children from Rapid City and the Cheyenne River Sioux/Oglala Lakota Reservations. We will work with the UCSF Bioassay Facility Core to develop a protocol for PFAS and untargeted suspect screening of serum samples from 52 AI children, including 26 asthma cases and 26 matched controls living in an urban (Rapid City SD) vs. rural (Reservation) environment. Specific Aim 2: Perform correlative and predictive modeling between PFAS/suspect chemicals and immunological biomarkers and response to viral respiratory infections in AI children with and without asthma. We will test for a correlation of PFAS/suspect chemicals with levels of immune biomarkers and viral- specific immunoglobulins. Immune biomarkers will include cytokines, Creactive protein, CBCs (white blood cell counts), total serum IgE, and viral specific IgG/IgM (SARs-CoV2, RSV, influenza, and rhinovirus C). Results from this aim will provide insights in to 1) the variability in exposure to environmental toxicants in children living in urban vs. rural (Reservation) locations and 2) the role of exposure to PFAS/suspect chemicals on immune dysregulation and asthma. Statistical analyses: We will examine the distribution of individual PFAS chemicals plus untargeted suspect chemicals to determine the relevant statistical test. In general, for commonly detected chemicals we will utilize linear and logistic regression models (or nonparametric tests) to test for associations between PFAS/suspect chemicals adjusting for multiple covariates selected through an iterative process (e.g. BMI, sex, household size, asthma medications); we will also contrast models with and without an asthma interaction. For rare chemicals we will apply a fisher’s exact test for detected/undetected. ROC curves will be generated for individual chemicals by asthma and location, and cluster analyses will be performed over all chemicals using a principal component analysis (with UMAP projection) and partial least-squares discriminant analysis (PLS-DA) for predictive modeling and Cox regression. Lastly, we will attempt a mediation analysis to evaluate if exposure to PFAS/suspect chemicals contributes to asthma via immune dysregulation. Relevance to the parent grant: The parent grant is centered on identifying social determinants of the environment including adverse childhood experiences that contribute to the development of asthma through altering the immunological response to viral respiratory infections. However, there is substantial evidence to suggest that exposure to environmental toxicants contribute to immune dysregulation in both the context of asthma and general immune function as discussed above. In this proposal, Dr. Spear will focus on the physical environment, specifically the role of exposure and accumulation of environmental toxicants on immune dysregulation in children with and without asthma.", "keywords": [], "approved": true } }, { "type": "Grant", "id": "15433", "attributes": { "award_id": "6R21HD112742-02", "title": "Designing effective RNA therapies for oocyte maturation", "funder": { "id": 4, "ror": "https://ror.org/01cwqze88", "name": "National Institutes of Health", "approved": true }, "funder_divisions": [ "Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)" ], "program_reference_codes": [], "program_officials": [ { "id": 27537, "first_name": "NEELAKANTA", "last_name": "RAVINDRANATH", "orcid": null, "emails": "", "private_emails": "", "keywords": null, "approved": true, "websites": null, "desired_collaboration": null, "comments": null, "affiliations": [] } ], "start_date": "2023-09-01", "end_date": "2025-08-31", "award_amount": 303504, "principal_investigator": { "id": 27910, "first_name": "Nehemiah Seth", "last_name": "Alvarez", "orcid": null, "emails": "", "private_emails": "", "keywords": null, "approved": true, "websites": null, "desired_collaboration": null, "comments": null, "affiliations": [] }, "other_investigators": [ { "id": 27911, "first_name": "Pavla", "last_name": "Brachova", "orcid": null, "emails": "", "private_emails": "", "keywords": null, "approved": true, "websites": null, "desired_collaboration": null, "comments": null, "affiliations": [] } ], "awardee_organization": { "id": 2542, "ror": "https://ror.org/04zjtrb98", "name": "Old Dominion University", "address": "", "city": "", "state": "VA", "zip": "", "country": "United States", "approved": true }, "abstract": "Infertility is a major reproductive health issue that affects ~12% of reproductively aged women in the United States. Approximately 1-3% of infertile or subfertile women have oocytes that arrest in meiosis or shortly after fertilization due to genetic variants. Unfortunately, there are no therapies for women experiencing infertility due to oocyte arrest. Strategies to restore oocyte maturation in women with oocyte arrest are of dire need in order to give these women fertility options. An emerging class of therapies, called mRNA therapeutics, utilize in vitro synthesized mRNA as a treatment for diseases and for vaccines such as the SARS-CoV-2 mRNA vaccines, but the safety and efficacy has not been explored in infertility. Microinjection of RNA into oocytes is an established tool that has enabled discovery of critical aspects of oocyte biology, but it could also be used as a therapeutic, particularly in women with oocyte arrest. Two recent studies successfully generated blastocysts in oocytes from women with genetic variants causing oocyte arrest, following the injection of in vitro synthesized wild-type RNA during assisted reproductive procedures. RNA therapies represent a novel treatment strategy for women experiencing oocyte arrest, however, rigorous testing is needed before they become an assisted reproductive technology. Considering the unique RNA processing and transcriptional quiescence of fully grown oocytes it is critical to understand how oocytes process exogenous RNA therapeutic molecules. Furthermore, synthetic therapeutic mRNA contain RNA modifications that promote RNA stability, translation, and reduce immune stimulation. Recently, our work and others have implicated RNA modifications as playing an important regulatory role in RNA stability and translation in oocytes. However, the impact of multiple RNA modifications on RNA stability, translation, and oocyte maturation has not been examined. Our goal here is to test how RNA modifications impact the function of mRNA therapeutics designed to rescue oocyte maturation defects. To understand how RNA therapeutics are processed by the oocyte and how they impact oocyte maturation and fertility, we will use a genetic knockout mouse model of the Protein Associated with Topoisomerase II Homolog 2 (Patl2 gene), which results in oocyte maturation arrest. Mice lacking PATL2 protein phenocopy women with genetic defects in Patl2, and have oocytes that fail to mature, so we predict that microinjection of an RNA therapeutic for Patl2 will restore oocyte maturation, fertilization, and birth. We will determine the effects of RNA modifications on stability and translation of therapeutic Patl2 RNA. Our studies have the potential to reveal novel aspects of RNA modifications in oocyte RNA processing and translation, as well as establish groundwork for future studies testing the safety and efficacy of RNA therapeutics to treat female infertility due to oocyte arrest.", "keywords": [], "approved": true } }, { "type": "Grant", "id": "15424", "attributes": { "award_id": "1SB1AG087755-01", "title": "Ryan® CompanionBot for Assisting Older Adults with Early-Stage Alzheimer's Disease and Dementia", "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": [ { "id": 32031, "first_name": "DINESH", "last_name": "John", "orcid": null, "emails": "", "private_emails": "", "keywords": null, "approved": true, "websites": null, "desired_collaboration": null, "comments": null, "affiliations": [] } ], "start_date": "2024-03-01", "end_date": "2026-05-31", "award_amount": 1424731, "principal_investigator": { "id": 32032, "first_name": "Mohammad", "last_name": "Mahoor", "orcid": null, "emails": "", "private_emails": "", "keywords": null, "approved": true, "websites": null, "desired_collaboration": null, "comments": null, "affiliations": [] }, "other_investigators": [], "awardee_organization": { "id": 2541, "ror": "", "name": "DREAM FACE TECHNOLOGIES, LLC", "address": "", "city": "", "state": "CO", "zip": "", "country": "United States", "approved": true }, "abstract": "The population of Americans age 65 years or older will increase from 58 million in 2021 to 88 million by 2050. By 2050, nearly 14 million older adults are expected to have AD/ADRD. For these individuals, significant care is required, and that care is often provided by family members. A 2022 study estimated that 11 million American family members are providing 16 billion hours of care valued at more than $272 billion. Senior care facilities are another option. The COVID-19 pandemic severely affected senior care facility residents. Despite representing only about 1% of the total population in the U.S., COVID-19 deaths in senior care facilities have made up nearly 40% of total COVID-19 deaths. Senior care facilities often face staffing shortages during and after the pandemic. Currently, 3 in 5 assisted living facilities are concerned that they may have to close due to staffing shortages. The situation with these two caregiving options is alarming; increasing demand for caregivers coupled with short supply has led to higher costs, unfilled needs, and fierce competition for resources. While computer technologies, such as wearable devices, are beginning to partially alleviate the shortage of caregivers, more powerful and personalized tools are needed. To address this urgent need, DreamFace Technologies, LLC invented Ryan® CompanionBot, a novel humanoid socially-assistive robot expertly tailored to the specific needs of older adults with early-stage AD/ADRD. The development of Ryan®, with the support of one NSF and two NIA/NIH SBIR grants, has been informed by 100 customer interviews and several subsequent field tests and clinical trials involving more than 50 older adults with early-stage AD/ADRD. In these tests, Ryan® has effectively delivered companionship, engaging conversations, physical and mental stimulation, daily activity reminders, and valuable assistance to the AD/ADRD-afflicted seniors powered by state-of-the-art artificial intelligence technologies such as facial expression recognition and synthesis, brain games, and empathic conversations while we also learned about several additional capabilities required for commercial success. Furthermore, in the pre-launch phase of the initial version of Ryan®, it has been deployed on a subscription basis at the esteemed senior care facility, Morningstar, which has served as a valuable beta site. In this Commercialization Readiness Pilot (CRP) program, we plan to complete the preparation of Ryan® for full commercialization. Specifically, we will: (1) refine and enhance Ryan®'s software and hardware, making mass manufacturing more efficient and cost-effective while making Ryan®'s operation more robust and easier to adopt by family members, staff, administrators, and caregivers in senior care facilities, (2) develop robust, integrated marketing and sales strategies, (3) develop an Intellectual Property strategy and required privacy policy and legal documents and (4) develop a financing and fundraising strategy for the successful commercialization of Ryan®. Upon the completion of the CRP project, we will have all the essential elements in place for the full commercialization of Ryan® as a transformative solution for senior care, benefiting both individuals diagnosed with early-stage AD/ADRD and caregivers alike.", "keywords": [], "approved": true } }, { "type": "Grant", "id": "15422", "attributes": { "award_id": "3R01MH118270-05S1", "title": "Efficacy of a Healthy Lifestyle Intervention to Prevent Depression in Older Spousally bereaved Adults - Supplement", "funder": { "id": 4, "ror": "https://ror.org/01cwqze88", "name": "National Institutes of Health", "approved": true }, "funder_divisions": [ "National Institute of Mental Health (NIMH)" ], "program_reference_codes": [], "program_officials": [ { "id": 20782, "first_name": "Jovier D", "last_name": "Evans", "orcid": null, "emails": "", "private_emails": "", "keywords": null, "approved": true, "websites": null, "desired_collaboration": null, "comments": null, "affiliations": [] } ], "start_date": "2024-04-01", "end_date": "2025-05-31", "award_amount": 90746, "principal_investigator": { "id": 20783, "first_name": "Sarah T", "last_name": "Stahl", "orcid": null, "emails": "[email protected]", "private_emails": null, "keywords": "[]", "approved": true, "websites": "[]", "desired_collaboration": "", "comments": "", "affiliations": [ { "id": 848, "ror": "", "name": "UNIVERSITY OF PITTSBURGH AT PITTSBURGH", "address": "", "city": "", "state": "PA", "zip": "", "country": "United States", "approved": true } ] }, "other_investigators": [], "awardee_organization": { "id": 2540, "ror": "", "name": "UNIVERSITY OF PITTSBURGH AT PITTSBURGH", "address": "", "city": "", "state": "PA", "zip": "", "country": "United States", "approved": true }, "abstract": "My ongoing research (R01 MH118270) examines the efficacy of a digital health intervention to stabilize the 24- hour rhythm of sleep, meals, and physical activity for reducing symptoms of depression in acutely-bereaved older adults. The onset of COVID-19 in 2020 occurred in tandem with the start-up phase of this study. As a result, I experienced significant setbacks because of the COVID-19 pandemic. First, the recruitment of older adults was significantly delayed (due to quarantine, social distancing, and participant concerns) and enrollment did not start until January of 2021 – 17 months into the project period. This delay had cascading effects on the study timeline and the feasibility of implementing a 15-month study in a newly-truncated project period. Second, I was an Early-Stage Investigator (ESI) who experienced significant disruptions to the startup of my independent research lab. Not only did I hire, train, and motivate staff in an uncertain and virtual working environment, but my reduced level of productivity impacted future milestones in my career trajectory (e.g., submission of new grants, development of new collaborations, and time to promotion). I exhausted all other means to overcome COVID-19 setbacks for this study. For instance, I modified the intervention and study protocol to be 100% contactless and virtual, and I expanded the reach of my intervention to geographic locations across the United States. Since the start of enrollment in 2021, my study team has enrolled 87% of our target sample and retained 91% of participants over the 15-month follow-up. I am confident in my team’s ability to finish this study. However, the parent aims may not be achievable unless I can secure additional funding to complete follow-up. In this administrative supplement, I propose to use additional funds for partial salary support for my study staff to complete post-intervention follow-up for 45 individuals. The proposed supplement aligns with NOT-MH-23 because (1) substantial components of the initial investment are at risk (e.g., longitudinal data are required for the planned analyses) and (2) I was an ESI implementing my first substantial research grant from the NIMH. This study is the first of its kind to test the effects of a circadian- influenced behavioral intervention on reducing depression after the loss of a spouse/life partner – a distressing albeit common life event in late life. Findings from this study will inform the development of widely generalizable and scalable technology-based intervention to support bereaved persons in community-based settings. However, additional funds are necessary to complete the project and collect post-intervention follow- up data.", "keywords": [], "approved": true } }, { "type": "Grant", "id": "15404", "attributes": { "award_id": "1R03AI178380-01A1", "title": "Characterizing the early childhood neurodevelopmental impact of infants exposed to maternal SARS-CoV-2 infection during pregnancy", "funder": { "id": 4, "ror": "https://ror.org/01cwqze88", "name": "National Institutes of Health", "approved": true }, "funder_divisions": [ "National Institute of Allergy and Infectious Diseases (NIAID)" ], "program_reference_codes": [], "program_officials": [ { "id": 6243, "first_name": "BROOKE ALLISON", "last_name": "Bozick", "orcid": null, "emails": "", "private_emails": "", "keywords": null, "approved": true, "websites": null, "desired_collaboration": null, "comments": null, "affiliations": [] } ], "start_date": "2024-07-16", "end_date": "2026-05-31", "award_amount": 83196, "principal_investigator": { "id": 32006, "first_name": "Leena Bhattacharya", "last_name": "Mithal", "orcid": null, "emails": "", "private_emails": "", "keywords": null, "approved": true, "websites": null, "desired_collaboration": null, "comments": null, "affiliations": [] }, "other_investigators": [], "awardee_organization": { "id": 2539, "ror": "", "name": "LURIE CHILDREN'S HOSPITAL OF CHICAGO", "address": "", "city": "", "state": "IL", "zip": "", "country": "United States", "approved": true }, "abstract": "Pregnant people are uniquely susceptible to SARS-CoV-2 infection, with risks of severe maternal COVID-19 illness and obstetric complications. However, far less is known about the long-term impact of pregnancy- associated SARS-CoV-2 infection on developing infants. Given the global burden, it is estimated that millions of pregnant people have had SARS-CoV-2 infection. Prior work by our Studying Novel Infectious Pathogens in Pregnancy (SNIPP) research team has identified distinct types of SARS-CoV-2-associated injury to the placenta, such as maternal vascular malperfusion and COVID placentitis. Further, we have identified unique inflammatory cytokine alterations in patients with specific types of placental lesions following SARS-CoV-2 during pregnancy. Maternal infection and inflammation can have a complex impact on early brain development and neurodevelopmental health outcomes. However, there have been very limited studies with differing conclusions addressing neurodevelopmental outcomes of infants born to mothers with SARS-CoV-2 in pregnancy. The existing literature to date utilizes methods limited by assessment of infants too early (≤12 months) and with diagnosis codes rather than direct evaluation of the child. With continued viral evolution and a generation of infants affected by the COVID-19 pandemic, it remains critical to learn if and how SARS-CoV-2 infection in pregnancy impacts childhood neurodevelopment health and risk of future dysfunction. Our central hypothesis is that pregnancy-associated SARS-CoV-2 infection and associated placental injury increases risk of adverse early childhood neurodevelopmental outcomes. We will investigate this hypothesis by utilizing our longitudinal SNIPP cohort of mother-infant pairs affected by SARS-CoV-2 infection during pregnancy (n~4000) with archived placental histopathology. We aim to characterize early childhood neurodevelopmental outcomes of infants following maternal SARS-CoV-2 during pregnancy by Aim 1(a): performing developmental assessments on infants born to the SARS-CoV-2-infected cohort along with pandemic timeframe uninfected controls; and Aim 1(b): exploring associations between neurodevelopmental abnormalities and placental injury with or without SARS-CoV-2 infection. In collaboration with Institute for Innovations in Developmental Sciences faculty, assessments will be performed using validated online parent surveys and remote video visits, focusing on both broad neurodevelopment and key domains for adaptive functioning: self-regulation and communication. A major impact of this work would be the identification of high-risk children who need close developmental monitoring. Strengths of our proposal include our large SNIPP cohort with paired biospecimens, sampling across the pandemic timeframe, and our transdisciplinary approach harnessing expertise in perinatal infection, placental pathology, and cutting-edge, pragmatic neurodevelopmental paradigms. This project uniquely poises us to address an important gap in knowledge that can impact near-term neurodevelopmental care and, through future research, lead to innovative risk stratification, mechanistic insight, and novel therapeutics to reduce harm.", "keywords": [], "approved": true } }, { "type": "Grant", "id": "15379", "attributes": { "award_id": "1R13FD008331-01", "title": "2024 FDA Retail Food Protection Seminar and Illinois Environmental Health Association’s Annual Education Conference", "funder": { "id": 4, "ror": "https://ror.org/01cwqze88", "name": "National Institutes of Health", "approved": true }, "funder_divisions": [], "program_reference_codes": [], "program_officials": [ { "id": 31980, "first_name": "Danielle", "last_name": "Head", "orcid": null, "emails": "", "private_emails": "", "keywords": null, "approved": true, "websites": null, "desired_collaboration": null, "comments": null, "affiliations": [] } ], "start_date": "2024-09-30", "end_date": "2025-08-31", "award_amount": 50000, "principal_investigator": { "id": 31981, "first_name": "Anna Marie", "last_name": "Yates", "orcid": null, "emails": "", "private_emails": "", "keywords": null, "approved": true, "websites": null, "desired_collaboration": null, "comments": null, "affiliations": [] }, "other_investigators": [], "awardee_organization": { "id": 2538, "ror": "", "name": "ILLINOIS ENVIRONMENTAL HEALTH ASSOCIATION", "address": "", "city": "", "state": "IL", "zip": "", "country": "United States", "approved": true }, "abstract": "FDA Support for Conferences and Scientific Meetings Funding Opportunity Announcement (FOA) Number: PAR-23-072 Participant: Illinois Environmental Health Association Program Dates: July 2024- December 2024 Project Summary Illinois Environmental Health Association is seeking funding from the FDA for the FDA Support for Conferences and Scientific Meetings Funding Opportnity. The funding will be used for the FDA/ IEHA Retail Food Seminar and Annual Education Conference in Chicago, Illinois. The Conference will be September 11-13, 2024 focusing on Food Safety. Our goal is to provide an opportunity for surrounding states to send their food program staff to a two and half day seminar where they will gain knowledge of food safety topics. Since the covid pandemic, it is pertinent that we continue providing opportunities for states to network and collaborate to keep up with the growing food integration. Our goal is to showcase the past, present, and future of public health through speakers and topics.", "keywords": [], "approved": true } }, { "type": "Grant", "id": "15360", "attributes": { "award_id": "1UG3DA059278-01A1", "title": "Development of SBS-226, a MOR agonist / DOR antagonist, for OUD", "funder": { "id": 4, "ror": "https://ror.org/01cwqze88", "name": "National Institutes of Health", "approved": true }, "funder_divisions": [ "National Institute on Drug Abuse (NIDA)" ], "program_reference_codes": [], "program_officials": [ { "id": 31959, "first_name": "David A", "last_name": "White", "orcid": null, "emails": "", "private_emails": "", "keywords": null, "approved": true, "websites": null, "desired_collaboration": null, "comments": null, "affiliations": [] } ], "start_date": "2024-09-30", "end_date": "2026-08-31", "award_amount": 3957359, "principal_investigator": { "id": 31960, "first_name": "Jeffrey", "last_name": "Reich", "orcid": null, "emails": "", "private_emails": "", "keywords": null, "approved": true, "websites": null, "desired_collaboration": null, "comments": null, "affiliations": [] }, "other_investigators": [], "awardee_organization": { "id": 2537, "ror": "", "name": "SPARIAN BIOSCIENCES, INC.", "address": "", "city": "", "state": "NY", "zip": "", "country": "United States", "approved": true }, "abstract": "Opioid use disorder (OUD) is a chronic disorder characterized by the repeated, compulsive use of opioid drugs with a detrimental impact to one’s physical, social, and psychological wellbeing. The use of prescription opiates is often necessary to control moderate to severe levels of pain. However, about 10% of patients prescribed an opiate for a medical condition are at risk for developing OUD. Opiate Use Disorder is a global problem but is at crisis levels in the U.S with significant mortality. It is estimated in this country that about ~11M misuse opioids, ~5.6M people have OUD and close to 80K died from opioid related overdoses. Sadly, the COVID epidemic has worsened the epidemic by increasing risk factors for OUD and occurred at a time when fentanyl has flooded the supply. Current treatments are primarily buprenorphine and methadone. Despite treatment options, OUD is difficult to effectively treat long-term due to access, stigma, and efficacy of the compounds. Mitragyna speciosa, a plant commonly known as kratom, has anecdotally been used for treatment of opiate withdrawal and OUD. The naturally occurring active substance is believed to be mitragynine and the 7- OH mitragynine (7OH) metabolite which act through the mu opioid receptor. An active metabolite of mitragynine, 7OH mitragynine, demonstrates MOR agonist properties such as analgesia, tolerance, physical dependence, and reinforcing effects. In contrast, an analog of mitragynine named 9-methoxy corynantheidine pseudoindoxyl (9CP) has a very different receptor binding profile and in vivo properties. 9CP is an partial agonist at MOR and it is also a delta opioid receptor (DOR) antagonist. Unlike the natural products found in kratom, when studied in mice under acute dosing 9CP is non-addictive, and demonstrates far less respiratory depression, tolerance, and signs of physical dependence than morphine. Most importantly, in mice, 9CP can ameliorate naloxone-precipitated withdrawal in morphine-dependent mice. Sparian has created a series of 9CP analogs and screened them across CMC, ADME, and PK properties and identified a lead candidate – SBS-226. Therefore, as an innovative pharmacological approach, we propose the development of SBS-226 as a novel selective, potent and non-addictive chemical entity utilizing mixed MOR agonism/DOR antagonism for the treatment of OUD. In the present application, we propose a full IND-enabling development plan and Phase 1 clinical trial.", "keywords": [], "approved": true } }, { "type": "Grant", "id": "15358", "attributes": { "award_id": "1R44DA061386-01", "title": "Right Tools, Right Time, Right Place: Telehealth for Opioid Use Disorder in Vulnerable Settings", "funder": { "id": 4, "ror": "https://ror.org/01cwqze88", "name": "National Institutes of Health", "approved": true }, "funder_divisions": [ "National Institute on Drug Abuse (NIDA)" ], "program_reference_codes": [], "program_officials": [ { "id": 27423, "first_name": "Morris", "last_name": "Flood", "orcid": null, "emails": "", "private_emails": "", "keywords": null, "approved": true, "websites": null, "desired_collaboration": null, "comments": null, "affiliations": [] } ], "start_date": "2024-09-15", "end_date": "2025-08-31", "award_amount": 297061, "principal_investigator": { "id": 31958, "first_name": "Stephanie", "last_name": "Papes", "orcid": null, "emails": "", "private_emails": "", "keywords": null, "approved": true, "websites": null, "desired_collaboration": null, "comments": null, "affiliations": [] }, "other_investigators": [], "awardee_organization": { "id": 2536, "ror": "", "name": "BOULDER CARE, INC.", "address": "", "city": "", "state": "OR", "zip": "", "country": "United States", "approved": true }, "abstract": "RFA-DA-24-018 Field-Deployable, Low-Cost Point-of-Need Approaches and Technologies to Lower the Barriers to Substance Use Disorders (SUD) Diagnosis and Treatment Twenty years after the FDA approval of buprenorphine for treatment of opioid use disorder (OUD), its availability remains far too restricted. This restriction is in spite of regulatory relaxations over these two decades: from increased panel size to broadening qualifying clinicians to ultimately removing any required waiver. It has also become clear that certain circumstances make patients especially vulnerable to harm from OUD. These include settings where medical attention is possible but buprenorphine is not provided (e.g, jails and prisons, emergency departments, and residential treatment for OUD), geographic areas where people are especially isolated from treatment (e.g, rural Tribal Nations), and life circumstances that confer additional risk (e.g., the perinatal period). We now have new tools to deliberately reach these settings. The regulatory suspension of an in-person visit during the COVID-19 pandemic allowed telehealth to dramatically increase its ability to care for patients, especially those with Medicaid. This increase in telehealth care has consequently allowed for research as to its effectiveness. Repeated studies find remote treatment with buprenorphine to be as good—and often better—than in-person treatment as usual. Research also calls attention to gaps that must be addressed to achieve treatment success with telehealth, including an affordable, readily-available working phone with reliable cellular and/or network coverage. These relatively low-cost technologies are the ones we propose to make available in the crucial settings described previously. Provision of a smartphone and connectivity will allow people in high-risk situations to begin treatment with Boulder Care’s proven approach and capabilities. We propose 5 partnerships that will, in Phase I, allow us to develop and test workflows with 5 participants per site and refine them for each setting, culminating with qualitative and quantitative research findings, including focus groups with participants and sites. With our workflows studied and optimized, our Phase II will then enroll 50 participants in Boulder Care from these 5 sites. Our primary endpoint, as with our prior SBIR grant, is duration of treatment with buprenorphine over a 48 week period. Secondary patient-centered outcomes will include measures of quality of life, functional outcomes, and assessments of recovery capital. Our partners include Sano Health, an experienced provider of technologies to vulnerable populations, and National Survivors Union, an organization of People Who Use Drugs who are accomplished community researchers. Together with site partners, this collaboration has proven, real-world, community-based expertise and will provide scalable life-saving treatment at the point of need.", "keywords": [], "approved": true } }, { "type": "Grant", "id": "15346", "attributes": { "award_id": "1R43JG000002-01", "title": "MiCRIA: Two-minute rapid assay platform for point-of-care diagnosis", "funder": { "id": 4, "ror": "https://ror.org/01cwqze88", "name": "National Institutes of Health", "approved": true }, "funder_divisions": [], "program_reference_codes": [], "program_officials": [], "start_date": "2024-09-30", "end_date": "2025-03-31", "award_amount": 303250, "principal_investigator": { "id": 31942, "first_name": "Andrew E.", "last_name": "Levin", "orcid": null, "emails": "", "private_emails": "", "keywords": null, "approved": true, "websites": null, "desired_collaboration": null, "comments": null, "affiliations": [] }, "other_investigators": [], "awardee_organization": { "id": 2535, "ror": "", "name": "KEPHERA DIAGNOSTICS, LLC", "address": "", "city": "", "state": "MA", "zip": "", "country": "United States", "approved": true }, "abstract": "Point-of-care testing has become one of the most rapidly growing fields in medicine, stimulated in recent years by the COVID-19 pandemic, but driven by the fundamental benefit that enabling healthcare workers to obtain actionable diagnostic results in the patient’s presence provides. Current point-of-care testing to detect the presence of antibodies or antigens as biomarkers of disease is dominated by lateral flow assay technology, which relies on methods established several decades ago. While simple to perform, lateral flow assays are the end product of a complex development process relying on sophisticated and costly instrumentation and the precise assembly of multiple material components. Scaling up lateral flow tests to commercial volumes requires specialty equipment and infrastructure, and is a bottleneck constraining the ability of many smaller assay developers to bring new point-of-care tests to commercial launch, hindering useful applications in public health. We have developed a novel point-of-care assay technology termed Magnetic Capture Rapid Immunoassay (MiCRIA™) that relies on principles that differ from those of lateral flow, and offers a sample-to-answer turnaround time of 2 minutes, significantly faster than most currently available methods. Sensitivity is greater than lateral flow and approaching ELISA. MiCRIA™ utilizes a microfluidic approach that simplifies the assay development process as well as scale up for production. Development of a new assay requires modification of only one reagent, while the basic assay component is a generic device that can be produced inexpensively in volume. Assay reagent production is a bulk process that can be scaled up to millions of units without requiring any specialized equipment, and that can be done on a benchtop in a matter of days by a skilled technician. A compact, low-cost reader reads the result and transmits it to a smartphone or other device for interpretation and data handling. Assay components can be made available to third party developers to create a new point-of-care ecosystem free of the constraints of lateral flow scale up, opening up the point-of-care diagnostics market to a broader global community of assay developers and users. Applications of the new assay technology include infectious and non-infectious disease testing, and any assay aimed at detection of antibodies, antigens, or nucleic acids. In this Phase I project, we will develop and establish the feasibility of the MiCRIA™ technology by demonstrating its application to the rapid detection of Chagas disease antibodies in a point-of-care diagnostic test. The MiCRIA™ Chagas test will address the need for more accessible testing for Chagas, which is the most prevalent parasitic disease in the western hemisphere, but with only 10% of cases currently diagnosed. Sensitivity and specificity of detection using the MiCRIA™ Chagas test will be compared with FDA-approved ELISA assays for Chagas disease. Establishment of feasibility through this project will pave the way for further development of the MiCRIA™ Chagas test and for MiCRIA™ as an open point-of-care platform with broad applications.", "keywords": [], "approved": true } }, { "type": "Grant", "id": "15326", "attributes": { "award_id": "1P20CA294096-01", "title": "Research Project", "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": "2024-09-20", "end_date": "2027-08-31", "award_amount": 410225, "principal_investigator": { "id": 31922, "first_name": "Nancy R", "last_name": "Cardona-Cordero", "orcid": null, "emails": "", "private_emails": "", "keywords": null, "approved": true, "websites": null, "desired_collaboration": null, "comments": null, "affiliations": [] }, "other_investigators": [], "awardee_organization": { "id": 2534, "ror": "", "name": "COMPREHENSIVE CANCER CENTER/ UNIV/PR", "address": "", "city": "", "state": "PR", "zip": "", "country": "United States", "approved": true }, "abstract": "RESEARCH PROJECT SUMMARY Climate change poses risks to human health through direct and indirect stressors. On tropical islands, some of the risks are accentuated. The population of the US Caribbean Territories, including Puerto Rico (PR) and the US Virgin Islands (USVI), is especially vulnerable to multiple concurrent hazards heightened by global climate change and the public health infrastructure that is weak, vulnerable, or absent due to historical and current problematic policies and practices. PR and USVI are experiencing acute socioeconomic and health consequences from extreme events including hurricanes Irma and Maria (2017) and the COVID-19 pandemic (2020-2022). The proposed Caribbean Climate Change Adaptation, Cancer, and Health Disparities Research Center (CCCARIB-CARES) will employ a multimethod approach to identify helpful strategies for addressing these problems. CCCARIB-CARES will employ an epidemiological study to assess the risk of cancer in PR and USVI in relation to climate vulnerabilities and socioenvironmental factors. It will include a cross-sectional study to assess understanding of climate change and its effects on mobilizing pollution and affecting the quality of life among cancer survivors. Furthermore, a qualitative study component will use key informants and focus groups to determine the needs, priorities and capabilities of stakeholder groups, cancer patients, and residents living in sites with low/high environmental disparities in relation to adaptation to climate-induced vulnerabilities. The primary aims of the proposed project are to 1) Describe the risk of cancer in PR and USVI in relation to climate stressors and socioenvironmental factors and 2) Conduct a community assessment of socioenvironmental climate stressors and adaptation capacity among cancer survivors and residents experiencing environmental disparities in PR and USVI. Information from the PR and USVI cancer registries will be used to assess cancer incidence and mortality risk in the context of historical and current environmental data, in a framework that evaluates social disparities. The study of the needs, priorities, and capabilities of stakeholder groups will uncover weaknesses in the cancer control and healthcare continuum. This information will guide the development of interventions and inform planning to respond and adapt to climate vulnerabilities in the Caribbean region. The findings will be of relevance for government-based planning and intervention efforts, including developing plans to mitigate the impacts of climate change locally, plans for disaster preparedness, and improving the resilience of cancer control plans and infrastructure for these US territories. Lessons learned will be of value to other US Territories Island states, and communities experiencing similar socio-environmental climate vulnerability nationally.", "keywords": [], "approved": true } } ], "meta": { "pagination": { "page": 2, "pages": 1392, "count": 13920 } } }