Other search tools

About this data

The publication data currently available has been vetted by Vanderbilt faculty, staff, administrators and trainees. The data itself is retrieved directly from NCBI's PubMed and is automatically updated on a weekly basis to ensure accuracy and completeness.

If you have any questions or comments, please contact us.

Results: 1 to 10 of 292

Publication Record

Connections

Parental Factors Associated With the Decision to Participate in a Neonatal Clinical Trial.
Weiss EM, Olszewski AE, Guttmann KF, Magnus BE, Li S, Shah AR, Juul SE, Wu YW, Ahmad KA, Bendel-Stenzel E, Isaza NA, Lampland AL, Mathur AM, Rao R, Riley D, Russell DG, Salih ZNI, Torr CB, Weitkamp JH, Anani UE, Chang T, Dudley J, Flibotte J, Havrilla EM, Kathen CM, O'Kane AC, Perez K, Stanley BJ, Wilfond BS, Shah SK
(2021) JAMA Netw Open 4: e2032106
MeSH Terms: Biomedical Research, Clinical Trials as Topic, Female, Humans, Infant, Newborn, Male, Parental Consent, Parents, Refusal to Participate, Surveys and Questionnaires, Trust
Show Abstract · Added April 16, 2021
Importance - It remains poorly understood how parents decide whether to enroll a child in a neonatal clinical trial. This is particularly true for parents from racial or ethnic minority populations. Understanding factors associated with enrollment decisions may improve recruitment processes for families, increase enrollment rates, and decrease disparities in research participation.
Objective - To assess differences in parental factors between parents who enrolled their infant and those who declined enrollment for a neonatal randomized clinical trial.
Design, Setting, and Participants - This survey study conducted from July 2017 to October 2019 in 12 US level 3 and 4 neonatal intensive care units included parents of infants who enrolled in the High-dose Erythropoietin for Asphyxia and Encephalopathy (HEAL) trial or who were eligible but declined enrollment. Data were analyzed October 2019 through July 2020.
Exposure - Parental choice of enrollment in neonatal clinical trial.
Main Outcomes and Measures - Percentages and odds ratios (ORs) of parent participation as categorized by demographic characteristics, self-assessment of child's medical condition, study comprehension, and trust in medical researchers. Survey questions were based on the hypothesis that parents who enrolled their infant in HEAL differ from those who declined enrollment across 4 categories: (1) infant characteristics and parental demographic characteristics, (2) perception of infant's illness, (3) study comprehension, and (4) trust in clinicians and researchers.
Results - Of a total 387 eligible parents, 269 (69.5%) completed the survey and were included in analysis. This included 183 of 242 (75.6%) of HEAL-enrolled and 86 of 145 (59.3%) of HEAL-declined parents. Parents who enrolled their infant had lower rates of Medicaid participation (74 [41.1%] vs 47 [55.3%]; P = .04) and higher rates of annual income greater than $55 000 (94 [52.8%] vs 30 [37.5%]; P = .03) compared with those who declined. Black parents had lower enrollment rates compared with White parents (OR, 0.35; 95% CI, 0.17-0.73). Parents who reported their infant's medical condition as more serious had higher enrollment rates (OR, 5.7; 95% CI, 2.0-16.3). Parents who enrolled their infant reported higher trust in medical researchers compared with parents who declined (mean [SD] difference, 5.3 [0.3-10.3]). There was no association between study comprehension and enrollment.
Conclusions and Relevance - In this study, the following factors were associated with neonatal clinical trial enrollment: demographic characteristics (ie, race/ethnicity, Medicaid status, and reported income), perception of illness, and trust in medical researchers. Future work to confirm these findings and explore the reasons behind them may lead to strategies for better engaging underrepresented groups in neonatal clinical research to reduce enrollment disparities.
0 Communities
1 Members
0 Resources
MeSH Terms
Cyt-Geist: Current and Future Challenges in Cytometry: Reports of the CYTO 2019 Conference Workshops.
Czechowska K, Lannigan J, Aghaeepour N, Back JB, Begum J, Behbehani G, Bispo C, Bitoun D, Fernández AB, Boova ST, Brinkman RR, Ciccolella CO, Cotleur B, Davies D, Dela Cruz GV, Del Rio-Guerra R, Des Lauriers-Cox AM, Douagi I, Dumrese C, Bonilla Escobar DL, Estevam J, Ewald C, Fossum A, Gaudillière B, Green C, Groves C, Hall C, Haque Y, Hedrick MN, Hogg K, Hsieh EWY, Irish J, Lederer J, Leipold M, Lewis-Tuffin LJ, Litwin V, Lopez P, Nasdala I, Nedbal J, Ohlsson-Wilhelm BM, Price KM, Rahman AH, Rayanki R, Rieger AM, Robinson JP, Shapiro H, Sun YS, Tang VA, Tesfa L, Telford WG, Walker R, Welsh JA, Wheeler P, Tárnok A
(2019) Cytometry A 95: 1236-1274
MeSH Terms: Animals, Clinical Trials as Topic, Flow Cytometry, Fluorescence, Guidelines as Topic, Humans, Inventions, Reproducibility of Results, Stem Cells, Surveys and Questionnaires
Added June 8, 2020
3 Communities
1 Members
0 Resources
10 MeSH Terms
Unmet need in rheumatology: reports from the Targeted Therapies meeting 2019.
Winthrop KL, Weinblatt ME, Bathon J, Burmester GR, Mease PJ, Crofford L, Bykerk V, Dougados M, Rosenbaum JT, Mariette X, Sieper J, Melchers F, Cronstein BN, Breedveld FC, Kalden J, Smolen JS, Furst D
(2020) Ann Rheum Dis 79: 88-93
MeSH Terms: Arthritis, Psoriatic, Arthritis, Rheumatoid, Biomedical Research, Central Nervous System Sensitization, Clinical Trials as Topic, Congresses as Topic, Humans, Lupus Erythematosus, Systemic, Molecular Targeted Therapy, Needs Assessment, Research, Research Design, Rheumatic Diseases, Rheumatology, Spondylitis, Ankylosing
Show Abstract · Added March 25, 2020
OBJECTIVES - To detail the greatest areas of unmet scientific and clinical needs in rheumatology.
METHODS - The 21st annual international Advances in Targeted Therapies meeting brought together more than 100 leading basic scientists and clinical researchers in rheumatology, immunology, epidemiology, molecular biology and other specialties. During the meeting, breakout sessions were convened, consisting of 5 disease-specific groups with 20-30 experts assigned to each group based on expertise. Specific groups included: rheumatoid arthritis, psoriatic arthritis, axial spondyloarthritis, systemic lupus erythematosus and other systemic autoimmune rheumatic diseases. In each group, experts were asked to identify unmet clinical and translational research needs in general and then to prioritise and detail the most important specific needs within each disease area.
RESULTS - Overarching themes across all disease states included the need to innovate clinical trial design with emphasis on studying patients with refractory disease, the development of trials that take into account disease endotypes and patients with overlapping inflammatory diseases, the need to better understand the prevalence and incidence of inflammatory diseases in developing regions of the world and ultimately to develop therapies that can cure inflammatory autoimmune diseases.
CONCLUSIONS - Unmet needs for new therapies and trial designs, particularly for those with treatment refractory disease, remain a top priority in rheumatology.
© Author(s) (or their employer(s)) 2020. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.
0 Communities
1 Members
0 Resources
15 MeSH Terms
Vaccine innovations for emerging infectious diseases-a symposium report.
Cable J, Srikantiah P, Crowe JE, Pulendran B, Hill A, Ginsberg A, Koff W, Mathew A, Ng T, Jansen K, Glenn G, Permar S, Wilson I, Weiner DB, Weissman D, Rappuoli R
(2020) Ann N Y Acad Sci 1462: 14-26
MeSH Terms: Animals, Clinical Trials as Topic, Communicable Disease Control, Communicable Diseases, Communicable Diseases, Emerging, Congresses as Topic, Humans, New York City, Research Report, Therapies, Investigational, Vaccines
Show Abstract · Added March 31, 2020
Vaccines have been incredibly successful at stemming the morbidity and mortality of infectious diseases worldwide. However, there are still no effective vaccines for many serious and potentially preventable infectious diseases. Advances in vaccine technology, including new delivery methods and adjuvants, as well as progress in systems biology and an increased understanding of the human immune system, hold the potential to address these issues. In addition, maternal immunization has opened an avenue to address infectious diseases in neonates and very young infants. This report summarizes the presentations from a 1-day symposium at the New York Academy of Sciences entitled "Innovative Vaccines against Resistant Infectious Diseases and Emerging Threats," held on May 20, 2019.
© 2019 New York Academy of Sciences.
0 Communities
1 Members
0 Resources
11 MeSH Terms
Pharmacogenomics.
Roden DM, McLeod HL, Relling MV, Williams MS, Mensah GA, Peterson JF, Van Driest SL
(2019) Lancet 394: 521-532
MeSH Terms: Clinical Trials as Topic, Drug-Related Side Effects and Adverse Reactions, Humans, Pharmacogenetics, Pharmacogenomic Variants
Show Abstract · Added March 24, 2020
Genomic medicine, which uses DNA variation to individualise and improve human health, is the subject of this Series of papers. The idea that genetic variation can be used to individualise drug therapy-the topic addressed here-is often viewed as within reach for genomic medicine. We have reviewed general mechanisms underlying variability in drug action, the role of genetic variation in mediating beneficial and adverse effects through variable drug concentrations (pharmacokinetics) and drug actions (pharmacodynamics), available data from clinical trials, and ongoing efforts to implement pharmacogenetics in clinical practice.
Copyright © 2019 Elsevier Ltd. All rights reserved.
0 Communities
1 Members
0 Resources
MeSH Terms
Myocarditis in the Setting of Cancer Therapeutics: Proposed Case Definitions for Emerging Clinical Syndromes in Cardio-Oncology
Bonaca MP, Olenchock BA, Salem JE, Wiviott SD, Ederhy S, Cohen A, Stewart GC, Choueiri TK, Di Carli M, Allenbach Y, Kumbhani DJ, Heinzerling L, Amiri-Kordestani L, Lyon AR, Thavendiranathan P, Padera R, Lichtman A, Liu PP, Johnson DB, Moslehi J
(2019) Circulation 140: 80-91
MeSH Terms: Antineoplastic Agents, Immunological, Cardiology, Clinical Trials as Topic, Humans, Immunotherapy, Medical Oncology, Myocarditis, Neoplasms
Show Abstract · Added November 12, 2019
Recent developments in cancer therapeutics have improved outcomes but have also been associated with cardiovascular complications. Therapies harnessing the immune system have been associated with an immune-mediated myocardial injury described as myocarditis. Immune checkpoint inhibitors are one such therapy with an increasing number of case and cohort reports describing a clinical syndrome of immune checkpoint inhibitor–associated myocarditis. Although the full spectrum of immune checkpoint inhibitor–associated cardiovascular disease still needs to be fully defined, described cases of myocarditis range from syndromes with mild signs and symptoms to fatal events. These observations in the clinical setting stand in contrast to outcomes from randomized clinical trials in which myocarditis is a rare event that is investigator reported and lacking in a specific case definition. The complexities associated with diagnosis, as well as the heterogeneous clinical presentation of immune checkpoint inhibitor–associated myocarditis, have made ascertainment and identification of myocarditis with high specificity challenging in clinical trials and other data sets, limiting the ability to better understand the incidence, outcomes, and predictors of these rare events. Therefore, establishing a uniform definition of myocarditis for application in clinical trials of cancer immunotherapies will enable greater understanding of these events. We propose an operational definition of cancer therapy-associated myocarditis that may facilitate case ascertainment and report and therefore may enhance the understanding of the incidence, outcomes, and risk factors of this novel clinical syndrome.
© 2019 American Heart Association, Inc.
0 Communities
1 Members
0 Resources
8 MeSH Terms
Assessing cardiac safety in oncology drug development.
Seltzer JH, Gintant G, Amiri-Kordestani L, Singer J, Koplowitz LP, Moslehi JJ, Barac A, Yu AF
(2019) Am Heart J 214: 125-133
MeSH Terms: Antineoplastic Agents, Antineoplastic Agents, Immunological, Biomarkers, Cardiologists, Cardiovascular Diseases, Cell Line, Tumor, Clinical Trials as Topic, Data Collection, Drug Development, Drug Screening Assays, Antitumor, Heart, Humans, Immunotherapy, Medical Oncology, Research Design, Trastuzumab
Added November 12, 2019
0 Communities
1 Members
0 Resources
16 MeSH Terms
Anticoagulation Strategies in Patients With Cancer: JACC Review Topic of the Week.
Mosarla RC, Vaduganathan M, Qamar A, Moslehi J, Piazza G, Giugliano RP
(2019) J Am Coll Cardiol 73: 1336-1349
MeSH Terms: Anticoagulants, Atrial Fibrillation, Blood Coagulation, Clinical Trials as Topic, Humans, Neoplasms, Practice Guidelines as Topic, Thromboembolism
Show Abstract · Added November 12, 2019
Patients with active cancer are at an increased risk of arterial and venous thromboembolism (VTE) and bleeding events. Historically, in patients with cancer, low molecular weight heparins have been preferred for treatment of VTE, whereas warfarin has been the standard anticoagulant for stroke prevention in patients with atrial fibrillation (AF). More recently, direct oral anticoagulants (DOACs) have been demonstrated to reduce the risk of venous and arterial thromboembolism in large randomized clinical trials of patients with VTE and AF, respectively, thus providing an attractive oral dosing option that does not require routine laboratory monitoring. In this review, we summarize available clinical trial data and guideline recommendations, and outline a practical approach to anticoagulation management of VTE and AF in cancer.
Copyright © 2019 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.
0 Communities
1 Members
0 Resources
8 MeSH Terms
Stroke in Children.
Jordan LC
(2019) Stroke 50: 230-232
MeSH Terms: Age of Onset, Cerebrovascular Disorders, Child, Clinical Trials as Topic, Humans
Added March 24, 2020
0 Communities
1 Members
0 Resources
MeSH Terms
Updated Recommendations on the Diagnosis, Management, and Clinical Trial Eligibility Criteria for Patients With Renal Medullary Carcinoma.
Msaouel P, Hong AL, Mullen EA, Atkins MB, Walker CL, Lee CH, Carden MA, Genovese G, Linehan WM, Rao P, Merino MJ, Grodman H, Dome JS, Fernandez CV, Geller JI, Apolo AB, Daw NC, Hodges HC, Moxey-Mims M, Wei D, Bottaro DP, Staehler M, Karam JA, Rathmell WK, Tannir NM
(2019) Clin Genitourin Cancer 17: 1-6
MeSH Terms: Carcinoma, Medullary, Carcinoma, Renal Cell, Clinical Trials as Topic, Databases, Factual, Eligibility Determination, Humans, Kidney Neoplasms, Patient Selection, Practice Guidelines as Topic, Prognosis
Show Abstract · Added October 30, 2019
Renal medullary carcinoma (RMC) is one of the most aggressive renal cell carcinomas. It predominantly afflicts young adults and adolescents with sickle cell trait and other sickle hemoglobinopathies, and is refractory to targeted and antiangiogenic therapies used in patients with clear-cell renal cell carcinoma. Platinum-based cytotoxic chemotherapy is the mainstay for RMC treatment. On the basis of recent advances in the diagnosis, management, and clinical trial development for RMC, a panel of experts met in October 2017 and developed updated consensus recommendations to inform clinicians, researchers, and patients. Because RMC often aggressively recurs while patients are still recovering from nephrectomy, upfront chemotherapy should be considered for most patients, including those with localized disease. After safety and dosing information has been established in adults, phase II and III trials enrolling patients with RMC should allow patients aged 12 years and older to be accrued. Patients with the very rare unclassified renal cell carcinoma with medullary phenotype variant should be included in RMC trials. Medical providers should be aware that RMC can afflict subjects of all races, and not only those of African descent, and that the presence of sickle cell trait, or of other sickle hemoglobinopathies, can affect drug responses and toxicity.
Copyright © 2018 Elsevier Inc. All rights reserved.
0 Communities
1 Members
0 Resources
MeSH Terms