Publications by authors named "Molly White"

Background: The US Kidney Allocation System allocates en bloc deceased donor kidney grafts from donors <18 kg in sequence A along with single kidney transplants (SKTs) from kidney donor profile index (KDPI) top 20% donors. Although en bloc grafts outperform SKT grafts holding donor weight constant, it is unclear if en bloc grafts from the smallest pediatric donors perform the same as top 20% KDPI SKTs.

Methods: Using the Scientific Registry of Transplant Recipients, we compared the donor characteristics and graft survival of en bloc grafts from the smallest donors (<8 kg) and from larger donors (≥8 kg) with SKTs by KDPI sequence for transplants performed in 2021.

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Rationale & Objective: The US Kidney Allocation System (KAS) prioritizes candidates with a≤20% estimated posttransplant survival (EPTS) to receive high-longevity kidneys defined by a≤20% Kidney Donor Profile Index (KDPI). Use of EPTS in the KAS deprioritizes candidates with older age, diabetes, and longer dialysis durations. We assessed whether this use also disadvantages race and ethnicity minority candidates, who are younger but more likely to have diabetes and longer durations of kidney failure requiring dialysis.

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Background: Engaging individuals living with disease in drug development and regulatory processes leads to more thoughtful and sensitive trial designs, drives more informative and meaningful outcomes from clinical studies, and builds trust between the public, government, and industry stakeholders. This engagement is especially important in the case of rare diseases, where affected individuals and their families face many difficulties getting information, treatment, and support. Dyne Therapeutics is developing therapeutics for people with genetically-driven muscle diseases.

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Importance: The 2022 US Supreme Court decision Dobbs v Jackson Women's Health Organization overturned federal protections to abortion care, allowing many states to severely restrict or ban access to abortion. Given the implications of the Dobbs ruling, there is a need to understand the full consequences of restricted abortion access. Before 2022, many states restricted access to safe and legal abortions through Targeted Regulation of Abortion Providers (TRAP) laws, which provide a historical mode for estimating the consequences of abortion restrictions.

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Nanosized materials have been proposed for a wide range of biomedical applications, given their unique characteristics. However, how these nanomaterials interact with cells and tissues, as well as how they bio-distribute in organisms, is still under investigation. Differences such as the nanoparticle size, shape, and surface chemistry affect the basic mechanisms of cellular uptake and responses, which, in turn, affects the nanoparticles' applicability for biomedical applications.

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For researchers, pharmaceutical companies, and regulatory agencies involved in the development of treatments that slow or stop disease progression, the highly variable and unpredictable progression of symptoms in myotonic dystrophy (DM) makes it difficult to assess whether an intervention provides clinically-meaningful benefit on disease progression for patients. In evaluating the effectiveness of treatments, drug developers and regulators need to understand what triggers progression, since the presence or absence of triggers may influence symptoms in ways that could complicate the assessment of progression. To better understand disease burden and what people living with DM view as meaningful benefits, Myotonic (formerly Myotonic Dystrophy Foundation) convened a meeting based on the US Food and Drug Administration's Patient-focused Drug Development initiative, at the Myotonic Annual Conference in September 2018.

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Myotonic dystrophy type 1 (DM1) and myotonic dystrophy type 2 (DM2) are multisystem, genetic disorders caused by repeat expansions on chromosome 19 (DM1) and chromosome 3 (DM2). Although the effects of DM on the skeletal, cardiac, and smooth muscles, as well as the endocrine and central nervous systems, can be disabling, there are no disease-modifying therapies for the disorder. Following a process established by the US Food and Drug Administration (FDA) in 2012 known as the Patient-Focused Drug Development (PFDD) Initiative, Myotonic (formerly the Myotonic Dystrophy Foundation) has been conducting patient- and caregiver-inclusive sessions to explore disease burden as defined by patients and caregivers, and what affected individuals want most from potential new therapies.

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Purpose Of Review: Myotonic dystrophy type 1 (DM1) is a severe, progressive genetic disease that affects between 1 in 3,000 and 8,000 individuals globally. No evidence-based guideline exists to inform the care of these patients, and most do not have access to multidisciplinary care centers staffed by experienced professionals, creating a clinical care deficit.

Recent Findings: The Myotonic Dystrophy Foundation (MDF) recruited 66 international clinicians experienced in DM1 patient care to develop consensus-based care recommendations.

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With increased ownership of backyard poultry, veterinarians must treat these birds appropriately and take into consideration drug withdrawal times for eggs meant for consumption. Few studies have examined the pharmacokinetics or egg residues for medications commonly used in avian medicine. This study determined the pharmacokinetics of meloxicam in domestic chickens (n = 8) after oral dosing at 1 mg/kg q12h for a total of 9 doses (5 days).

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OBJECTIVE To determine the pharmacokinetics of meloxicam in domestic hens and duration and quantity of drug residues in their eggs following PO administration of a single dose (1 mg of meloxicam/kg). ANIMALS 8 healthy adult White Leghorn hens. PROCEDURES Hens were administered 1 mg of meloxicam/kg PO once.

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Myotonic dystrophy (DM) is an autosomal dominant, repeat expansion, progressive disorder with no drug therapies. Consequently, to better define a regulatory pathway in anticipation of new treatment strategies under investigation, the Myotonic Dystrophy Foundation convened a workshop entitled "Patient-Centered Therapy Development for Myotonic Dystrophy" in September 2015. Participants included representatives from academia, industry, the patient community, the National Institutes of Health (NIH) and the Food and Drug Administration (FDA).

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A new method of analysis has been developed and validated for the determination of meloxicam in egg whites and yolks. Following a liquid extraction for the whites and a solid phase extraction for the yolks, samples were separated on an XBridge C18 column and quantified using ultraviolet detection at 360 nm. The mobile phase was a mixture of water with glacial acetic acid and acetonitrile, with a flow rate of 1 mL/min.

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Introduction: Antibody-mediated rejection (ABMR) is dependent on complement activating donor-specific anti-HLA antibodies (DSA). This is commonly detected by C4d deposition in allografts. However, recent data define a C4d negative ABMR phenotype suggesting a role for complement-independent DSA injury, antibody-dependent cellular cytotoxicity (ADCC).

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Overweight among America's youth has prompted a large response from foundations, government, and private organizations to support programmatic interventions. The architecture for many of these programs was derived from "experts," whereas the perspective of families, and communities--those most affected and most instrumental in altering behavior--is rarely the driving force. Shaping America's Youth (SAY) was established to assess programs that target nutrition and physical activity and to promote the necessary family and community input.

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Hemoglobin (Hb)-based oxygen carriers (HBOCs) are being developed as a potential therapy for increasing tissue oxygenation, yet they have not reached their full potential because of unwanted hemodynamic side effects (vasoconstriction, low cardiac output, and oxygen delivery) due in part to nitric oxide (NO) scavenging by cell-free Hb. It may be possible to overcome the NO scavenging effect by coinfusing S-nitrosylated (SNO) HBOC along with unmodified HBOC. SNO-HBOC, like free Hb, may act as an NO donor in low-oxygen conditions.

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Acute hypoxia causes pulmonary vascular leak and is involved in the pathogenesis of pulmonary edema associated with inflammation, acute altitude exposure, and other critical illnesses. Reactive oxygen species, HIF-1, and VEGF have all been implicated in various hypoxic pathologies, yet the ROS-HIF-1-VEGF pathway in pulmonary vascular leak has not been defined. We hypothesized that the ROS-HIF-1-VEGF pathway has an important role in producing hypoxia-induced pulmonary vascular leak.

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Hemoglobin-based oxygen carriers (HBOC) have been primarily studied for blood loss treatment. More recently infusions of HBOC in euvolemic subjects have been proposed for a wide variety of potential therapies in which increased tissue oxygenation would be beneficial. However, compared with the exchange transfusion models to study blood loss, less is known about HBOC oxygen delivery and vasoacitvity when it is infused in euvolemic subjects.

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Objective: To examine the contribution of perceived importance of activities of daily living (ADL) to arthritis-specific helplessness in a sample of rheumatoid arthritis (RA) patients over a 1-year period.

Method: Forty-two individuals from an outpatient rheumatology clinic completed measures of ADL importance, helplessness, depression, pain, and disability; the physician's assistant provided objective ratings of disability.

Results: Time 1 importance of ADL predicted a significant amount of variance in Time 2 arthritis helplessness after statistically controlling disease and psychological covariates.

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Objective: To examine the role of children's illness-related cognitive appraisals in the parent-child adjustment relationship in a sample of children and adolescents with juvenile rheumatic disease (JRD). Specifically, we tested the moderating effect of children's perceived illness-induced barriers (i.e.

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