A5019884239- Acute Lymphoblastic Leukemia research
- Chronic Lymphocytic Leukemia Research
- Chronic Myeloid Leukemia Treatments
- CAR-T cell therapy research
- Lymphoma Diagnosis and Treatment
- Statistical Methods in Clinical Trials
- Biomedical Ethics and Regulation
- Cancer Genomics and Diagnostics
- Shoulder Injury and Treatment
- Health Systems, Economic Evaluations, Quality of Life
- Musculoskeletal Disorders and Rehabilitation
- HER2/EGFR in Cancer Research
- Bone fractures and treatments
- Protein Degradation and Inhibitors
- Health and Lifestyle Studies
- Child Abuse and Trauma
- Tendon Structure and Treatment
- Genetic and Kidney Cyst Diseases
- Homicide, Infanticide, and Child Abuse
- Health Education and Validation
- Viral-associated cancers and disorders
- Medical Imaging Techniques and Applications
- Sports injuries and prevention
- Nursing Diagnosis and Documentation
- Lung Cancer Research Studies
United States Food and Drug Administration
2020-2024
Center for Drug Evaluation and Research
2019-2023
University of Indianapolis
2022
Indiana University – Purdue University Indianapolis
2022
Erlanger Health System
2017
University Health System
2017
Albany Medical Center Hospital
2014-2017
University of Tennessee at Chattanooga
2016
Vanderbilt University
2016
In November 2018, the U.S. Food and Drug Administration (FDA) approved brentuximab vedotin (BV) for treatment of adult patients with previously untreated systemic anaplastic large cell lymphoma or other CD30-expressing peripheral T-cell lymphomas (PTCL), including angioimmunoblastic PTCL not otherwise specified, in combination cyclophosphamide, doxorubicin, prednisone (CHP). Approval was based on ECHELON-2, a randomized, double-blind, actively controlled trial that compared BV+CHP...
In January 2021, the U.S. Food and Drug Administration (FDA) approved crizotinib for pediatric patients 1 year older young adults with relapsed or refractory systemic anaplastic large cell lymphoma (sALCL). This is first approval sALCL. Approval was based on a single-arm trial of monotherapy that included 26 patients, aged 1-20 years, previously treated Efficacy centrally assessed objective response rate (88%) duration response. Herein, we highlight unique aspects regulatory review,...
Objective: Golf is a widely popular sport in the United States with 29 million Americans participating game. With an aging population and increased incidence of glenohumeral degenerative arthritis, number active golfers requiring total shoulder replacement on rise. This study aims to evaluate effect golfing activity. Design: Retrospective; questionnaire. Setting: Survey. Participants: Three hundred sixty-seven patients were identified based Current Procedural Terminology codes who underwent...
Abstract Minimal residual disease (MRD) is increasingly used as a prognostic biomarker, measure of clinical efficacy, and guide for treatment decisions in various hematologic malignancies. We sought to characterize MRD data registrational trials malignancies submitted the U.S. Food Drug Administration (FDA) with ultimate goal expanding utility future drug applications. descriptively analyzed collected trials, including type endpoint, assay, compartment(s) assessed, acceptance prescribing...
The standard for evaluating scoliosis is PA radiographs using Cobb angle to measure curve magnitude. Newer PACS systems allow easier calculations, but have not improved inter/intra observer precision of measurement. and its progression are important determine treatment; therefore, variability optimal. This study seeks demonstrate that a performance equivalent achieved in the manual method possible novel computer algorithm with limited user input. authors compared angles from predetermined...
In April 2023, the U.S. Food and Drug Administration granted regular approval to polatuzumab vedotin-piiq in combination with a rituximab product, cyclophosphamide, doxorubicin, prednisone (pola+R-CHP) for adult patients who have previously untreated diffuse large B-cell lymphoma, not otherwise specified or high-grade lymphoma an International Prognostic Index score of 2 greater. Approval was based on POLARIX, randomized, double-blinded, placebo-controlled trial evaluating superiority...
Molecularly targeted therapies such as tyrosine kinase inhibitors (TKI) are effective treatments for B-cell receptor (BCR)-ABL-bearing leukemias. We evaluated the impact of TKIs on historical chronic myeloid leukemia (CML) mortality trends compared with acute lymphoblastic (ALL) and (CLL).Because reflect combined effects incidence survival, we also contribution survival to by subtypes. used data from 13 U.S. (SEER) registries (1992-2017) among adults. utilized histology codes identify cases...
Abstract On May 16, 2019, the U.S. Food and Drug Administration (FDA) approved dalteparin sodium for treatment of symptomatic venous thromboembolism (VTE) to reduce risk recurrence in pediatric patients 1 month age older. Approval was primarily based on FDA review a single‐arm trial evaluating administered subcutaneous twice daily 38 with VTE. Efficacy achievement therapeutic plasma anti‐Xa levels. The concluded that has efficacy acceptable safety patients.
Master protocol studies typically use an overarching to answer several questions by guiding a variety of sub-studies. These sub-studies can incorporate multiple diseases, therapies, or both. Although this innovative approach offers many benefits, including the ability deliver clinical research that is more patient-centric and efficient, common barriers curtail widespread adoption. The Clinical Trials Transformation Initiative (CTTI) convened industry representatives, regulatory agencies,...
<div>AbstractIntroduction:<p>Molecularly targeted therapies such as tyrosine kinase inhibitors (TKI) are effective treatments for B-cell receptor (BCR)-ABL–bearing leukemias. We evaluated the impact of TKIs on historical chronic myeloid leukemia (CML) mortality trends compared with acute lymphoblastic (ALL) and (CLL).</p>Methods:<p>Because reflect combined effects incidence survival, we also contribution survival to by subtypes. used data from 13 U.S. (SEER)...
<p>Supplementary Figure 1: Trends in Mortality by Leukemia Subtypes and Race Ethnicity. Total US 1992-2018. Results are shown for mortality trends CML (panel A), ALL B), CLL C), For each panel, we show age-adjusted rates five mutually exclusive race-ethnicity categories: non-Hispanic White, Black, Asian Pacific Islander, American Indian/Alaskan Natives, Hispanic.</p>
<p>Supplementary Figure 1: Trends in Mortality by Leukemia Subtypes and Race Ethnicity. Total US 1992-2018. Results are shown for mortality trends CML (panel A), ALL B), CLL C), For each panel, we show age-adjusted rates five mutually exclusive race-ethnicity categories: non-Hispanic White, Black, Asian Pacific Islander, American Indian/Alaskan Natives, Hispanic.</p>
e19082 Background: Clinical response assessment criteria, such as RECIST v1.1 and Lugano 2014, provide a standardized approach to assess treatment effectiveness in oncology clinical trials. Corresponding methodologies are needed for real-world data (RWD) improve interpretability alongside trial facilitate replication of results across RWD studies. We developed novel methodology, (rwLugano), derived from 2014 criteria classify lymphoma among patients with diffuse large B-cell (DLBCL)....
e19081 Background: Innovation in the use of real-world data (RWD) for regulatory purposes is an important provision 21st Century Cures Act. Numerous initiatives to enhance RWD methodologies oncology drug development are ongoing, including evaluation treatment response assessment support effectiveness research. Blinded independent central review (BICR) standardizes clinical trials, and corresponding needed. This study assess feasibility BICR using RWD, evaluates a novel, standardized...
<p>Supplementary Figure 1: Trends in Mortality by Leukemia Subtypes and Race Ethnicity. Total US 1992-2018. Results are shown for mortality trends CML (panel A), ALL B), CLL C), For each panel, we show age-adjusted rates five mutually exclusive race-ethnicity categories: non-Hispanic White, Black, Asian Pacific Islander, American Indian/Alaskan Natives, Hispanic.</p>
<p>Supplementary Figure 1: Trends in Mortality by Leukemia Subtypes and Race Ethnicity. Total US 1992-2018. Results are shown for mortality trends CML (panel A), ALL B), CLL C), For each panel, we show age-adjusted rates five mutually exclusive race-ethnicity categories: non-Hispanic White, Black, Asian Pacific Islander, American Indian/Alaskan Natives, Hispanic.</p>
<div>Abstract<p>Introduction: Molecularly targeted therapies such as tyrosine kinase inhibitors (TKIs) are effective treatments for BCR-ABL-bearing leukemias. We evaluated the impact of TKIs on historical chronic myeloid leukemia (CML) mortality trends compared to acute lymphoblastic (ALL) and (CLL). Methods: Since reflect combined effects incidence survival, we also contribution survival by subtypes. used data from 13 US SEER registries (1992-2017) among adults. utilized...
Summary: Cancer drug development remained robust in 2023. Highlights of U.S. approvals this year include new immunotherapies and targeted adult pediatric patients as well with rare diseases.
Every pediatric hospitalist has faced a scenario like this many times. Making the correct diagnosis is critical, because children with missed inflicted head trauma are at high risk for sustaining more trauma, and represents most common cause of death in abused children.1 Although literature concerning child abuse evolved, establishing still requires astute clinical judgment along evidence-based practice. Unfortunately, no definitive test abusive currently exists.The known subjection to dates...
e14125 Background: Cancer therapeutics often receive FDA approval months to years before regulatory submission other countries. [i] Registrational trials in oncology are increasingly international, with many patients enrolled outside of the United States. Harmonizing access new global standards treatment may facilitate optimal design and conduct clinical trials. Methods: In May 2019, Oncology Center for Excellence launched Project Orbis collaboration Australian Therapeutic Good...
Foot and ankle pathology is commonly encountered by healthcare professionals. A basic understanding of footwear orthotics proves helpful in the overall treatment these patients. The following an overview orthosis basics for aimed toward medical