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University of Nevada, Las Vegas

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Full-Text Articles in Clinical Trials

Cognitive Effects Of The Bet Protein Inhibitor Apabetalone: A Prespecified Montreal Cognitive Assessment Analysis Nested In The Betonmace Randomized Controlled Trial, Jeffrey Cummings, Gregory G. Schwartz, Stephen J. Nicholls, Aziz Khan, Chris Halliday, Peter P. Toth, Michael Sweeney, Jan O. Johansson, Norman C.W. Wong, Ewelina Kulikowski, Kamyar Kalantar-Zadeh, Kenneth Lebioda, Henry N. Ginsberg, Bengt Winblad, Henrik Zetterberg, Kausik K. Ray Oct 2021

Cognitive Effects Of The Bet Protein Inhibitor Apabetalone: A Prespecified Montreal Cognitive Assessment Analysis Nested In The Betonmace Randomized Controlled Trial, Jeffrey Cummings, Gregory G. Schwartz, Stephen J. Nicholls, Aziz Khan, Chris Halliday, Peter P. Toth, Michael Sweeney, Jan O. Johansson, Norman C.W. Wong, Ewelina Kulikowski, Kamyar Kalantar-Zadeh, Kenneth Lebioda, Henry N. Ginsberg, Bengt Winblad, Henrik Zetterberg, Kausik K. Ray

School of Medicine Faculty Research

Background: Epigenetic changes may contribute importantly to cognitive decline in late life including Alzheimer's disease (AD) and vascular dementia (VaD). Bromodomain and extra-terminal (BET) proteins are epigenetic 'readers' that may distort normal gene expression and contribute to chronic disorders. Objective: To assess the effects of apabetalone, a small molecule BET protein inhibitor, on cognitive performance of patients 70 years or older participating in a randomized trial of patients at high risk for major cardiovascular events (MACE). Methods: The Montreal Cognitive Assessment (MoCA) was performed on all patients 70 years or older at the time of randomization. 464 participants were randomized …


Optimal Two-Stage Designs Based On Restricted Mean Survival Time For A Single-Arm Study, Guogen Shan Jan 2021

Optimal Two-Stage Designs Based On Restricted Mean Survival Time For A Single-Arm Study, Guogen Shan

School of Public Health Faculty Research

© 2021 The Author(s) Restricted mean survival time is an alternative measure of treatment effect to hazard ratio in clinical trials with time-to-event outcome. The current methods have been focused on one-stage designs. In this article, we propose optimal two-stage designs for a single-arm study with the smallest expected sample size. We compare the performance of the new optimal two-stage designs with the existing one-stage design with regards to the expected sample size and the expected total study length. The simulation results indicate that the new two-stage designs can save the expected sample size substantially as compared to the one-stage …


Tricyclic Antidepressant Use And Risk Of Fractures: A Meta-Analysis Of Cohort Studies Through The Use Of Both Frequentist And Bayesian Approaches, Qing Wu, Yingke Xu, Yueyang Bao, Jovan Alvarez, Mikee Lianne Gonzales Aug 2020

Tricyclic Antidepressant Use And Risk Of Fractures: A Meta-Analysis Of Cohort Studies Through The Use Of Both Frequentist And Bayesian Approaches, Qing Wu, Yingke Xu, Yueyang Bao, Jovan Alvarez, Mikee Lianne Gonzales

School of Medicine Faculty Research

Background: Research findings regarding the association between tricyclic antidepressant (TCA) treatment and the risk of fracture are not consistent; we aimed to assess whether people who take TCAs are at an increased fracture risk. Methods: Relevant studies published through June 2020 were identified through database searches of MEDLINE, EMBASE, Scopus, PsycINFO, ISI Web of Science, WorldCat Dissertations and Theses from each database’s inception, as well as through manual searches of relevant reference lists. Two researchers independently performed literature searches, study selection, data abstraction and study appraisal by using a standardized protocol. Frequentist and Bayesian hierarchical random-effects models were used for …


Utility Of Inflammatory Markers To Predict Adverse Outcome In Acute Pancreatitis: A Retrospective Study In A Single Academic Center, Mohamad Mubder, Banreet Dhindsa, Danny Nguyen, Syed Saghir, Chad Cross, Ranjit Makar, Gordon Ohning Jul 2020

Utility Of Inflammatory Markers To Predict Adverse Outcome In Acute Pancreatitis: A Retrospective Study In A Single Academic Center, Mohamad Mubder, Banreet Dhindsa, Danny Nguyen, Syed Saghir, Chad Cross, Ranjit Makar, Gordon Ohning

School of Medicine Faculty Research

Background/Aim: Acute pancreatitis (AP) is a commonly encountered emergency where early identification of complicated cases is important. Inflammatory markers like lymphocyte to monocyte ratio (LMR) and neutrophil to lymphocyte ratio (NLR) are simple and readily available markers. In this study, we evaluated the utility of these markers in the early identification of patients with complicated AP. Patients and Methods: All patients with a diagnosis of AP admitted to the University Medical Center in Las Vegas/Nevada between August 2015 and September 2018 were identified using ICD-10 codes. Medical records were reviewed retrospectively. Epidemiological measures and their associated confidence intervals were calculated …


Variations In Institutional Review Board Processes And Consent Requirements For Trauma Research: An East Multicenter Survey, Jeffry Nahmias, Areg Grigorian, Scott Brakenridge, Randeep S. Jawa, Daniel N. Holena, John Varujan Agapian, Brandon Bruns, Paul J. Chestovich, Bruce Chung, Jonathan Nguyen, Carl I. Schulman, Kristan Staudenmayer, Rachel Dixon, Jason W. Smith, Andrew C. Bernard, Jose L. Pascual May 2018

Variations In Institutional Review Board Processes And Consent Requirements For Trauma Research: An East Multicenter Survey, Jeffry Nahmias, Areg Grigorian, Scott Brakenridge, Randeep S. Jawa, Daniel N. Holena, John Varujan Agapian, Brandon Bruns, Paul J. Chestovich, Bruce Chung, Jonathan Nguyen, Carl I. Schulman, Kristan Staudenmayer, Rachel Dixon, Jason W. Smith, Andrew C. Bernard, Jose L. Pascual

School of Medicine Faculty Research

Oversight of human subject research has evolved considerably since its inception. However, previous studies identified a lack of consistency of institutional review board (IRB) determination for the type of review required and whether informed consent is necessary, especially for prospective observational studies, which pose minimal risk of harm. We hypothesized that there is significant inter-institution variation in IRB requirements for the type of review and necessity of informed consent, especially for prospective observational trials without blood/tissue utilization. We also sought to describe investigators’ and IRB members’ attitudes toward the type of review and need for consent. Eastern Association for the …


The Role Of Functional, Social, And Mobility Dynamics In Facilitating Older African Americans Participation In Clinical Research, Eve T. Shapiro, Jay T. Schamel, Kimberly A. Parker, Laura A. Randall, Paula M. Frew Mar 2017

The Role Of Functional, Social, And Mobility Dynamics In Facilitating Older African Americans Participation In Clinical Research, Eve T. Shapiro, Jay T. Schamel, Kimberly A. Parker, Laura A. Randall, Paula M. Frew

Environmental & Global Health Faculty Research

Purpose: Older African Americans experience disproportionately higher incidence of morbidity and mortality related to chronic and infectious diseases, yet are significantly underrepresented in clinical research compared to other racial and ethnic groups. This study aimed to understand the extent to which social support, transportation access, and physical impediments function as barriers or facilitators to clinical trial recruitment of older African Americans. Methods: Participants (N=221) were recruited from six African American churches in Atlanta and surveyed on various influences on clinical trial participation.


Phase I Dose-Escalation Trial Of Intravaginal Curcumin In Women For Cervical Dysplasia, Leda Gattoc, Paula M. Frew, Shontell N. Thomas, Kirk A. Easley, Laura Ward, H-H Sherry Chow, Chiemi A. Ura, Lisa Flowers Dec 2016

Phase I Dose-Escalation Trial Of Intravaginal Curcumin In Women For Cervical Dysplasia, Leda Gattoc, Paula M. Frew, Shontell N. Thomas, Kirk A. Easley, Laura Ward, H-H Sherry Chow, Chiemi A. Ura, Lisa Flowers

Environmental & Global Health Faculty Research

Background: This is a Phase I trial demonstrating safety and tolerability of intravaginal curcumin for future use in women with cervical neoplasia. Objective: The objective of this study was to assess the safety, tolerability, and pharmacokinetics of intravaginal curcumin in healthy women. Study design: We conducted a 3+3 dose-escalation Phase I trial in a group of women aged 18–45 years. Thirteen subjects were given one of four doses of curcumin powder (500 mg, 1,000 mg, 1,500 mg, and 2,000 mg) packed in gelatin capsules, which was administered intravaginally daily for 14 days. The primary end point for this study was …


A Study Of Joinpoint Models For Longitudinal Data, Libo Zhou Aug 2014

A Study Of Joinpoint Models For Longitudinal Data, Libo Zhou

UNLV Theses, Dissertations, Professional Papers, and Capstones

In many medical studies, data are collected simultaneously on multiple biomarkers from each individual. Levels of these biomarkers are measured periodically over certain time duration, giving rise to longitudinal trajectories. The subjects under study may also be subject to dropout due to several competing causes, the likelihood of which may be affected by the levels of these biomarkers. In this dissertation, we investigate flexible Bayesian modeling of such data, taking into account any available covariate information as well as possible censoring of the drop-out times. We propose joint models for multiple biomarkers with multiple causes of dropout. Our proposed models …


In Step With Hiv Vaccines? A Content Analysis Of Local Recruitment Campaigns For An International Hiv Vaccine Study, Paula M. Frew, Wendy Macias, Kayshin Chan, Ashley Harding Jan 2009

In Step With Hiv Vaccines? A Content Analysis Of Local Recruitment Campaigns For An International Hiv Vaccine Study, Paula M. Frew, Wendy Macias, Kayshin Chan, Ashley Harding

Environmental & Global Health Faculty Research

During the past two decades of the HIV/AIDS pandemic, several recruitment campaigns were designed to generate community involvement in preventive HIV vaccine clinical trials. These efforts utilized a blend of advertising and marketing strategies mixed with public relations and community education approaches to attract potential study participants to clinical trials (integrated marketing communications). Although more than 30,000 persons worldwide have participated in preventive HIV vaccine studies, no systematic analysis of recruitment campaigns exists. This content analysis study was conducted to examine several United States and Canadian recruitment campaigns for one of the largest-scale HIV vaccine trials to date (the “Step …