Open Access. Powered by Scholars. Published by Universities.®

Clinical Trials Commons

Open Access. Powered by Scholars. Published by Universities.®

162 Full-Text Articles 432 Authors 47,975 Downloads 28 Institutions

All Articles in Clinical Trials

Faceted Search

162 full-text articles. Page 1 of 5.

Computer Aided Clinical Trials For Implantable Cardiac Devices, Rahul Mangharam 2018 University of Pennsylvania

Computer Aided Clinical Trials For Implantable Cardiac Devices, Rahul Mangharam

Real-Time and Embedded Systems Lab (mLAB)

In this paper we aim to answer the question, ``How can modeling and simulation of physiological systems be used to evaluate life-critical implantable medical devices?'' Clinical trials for medical devices are becoming increasingly inefficient as they take several years to conduct, at very high cost and suffer from high rates of failure. For example, the Rhythm ID Goes Head-to-head Trial (RIGHT) sought to evaluate the performance of two arrhythmia discriminator algorithms for implantable cardioverter defibrillators, Vitality 2 vs. Medtronic, in terms of time-to-first inappropriate therapy, but concluded with results contrary to the initial hypothesis - after 5 years, 2,000+ patients ...


Analysis Of Patient Recruitment Methods For Clinical Trials Of Different Heart And Lung Diseases, Oghenevovwero Vovwe Sido 2018 University of North Texas Health Science Center at Fort Worth

Analysis Of Patient Recruitment Methods For Clinical Trials Of Different Heart And Lung Diseases, Oghenevovwero Vovwe Sido

Theses and Dissertations

Patient recruitment is key to the success of any clinical trial, as clinical trials cannot be conducted without the willful participation of subjects. However, clinical trial recruitment has always been a great challenge in clinical studies. This practicum project conducted over an eight-month period, compares three different methods of subject recruitment into 2 clinical research studies conducted at the Heart & Lung Transplant and Pulmonary Research Department of Baylor Scott & White Research Institute, Dallas. The three recruitment methods are: Physician Referral, EHR Screening and Online Portals. We hypothesize that Physician referral is a more successful method for enrolling patients into clinical ...


Robust Multivariate Nonparametric Tests For Detection Of Two-Sample Location Shift In Clinical Trials, Xuejun Jiang, Xu Guo, Ning Zhang, Bo Wang, Bo Zhang 2018 Southern University of Science and Technology

Robust Multivariate Nonparametric Tests For Detection Of Two-Sample Location Shift In Clinical Trials, Xuejun Jiang, Xu Guo, Ning Zhang, Bo Wang, Bo Zhang

Open Access Articles

This article presents and investigates performance of a series of robust multivariate nonparametric tests for detection of location shift between two multivariate samples in randomized controlled trials. The tests are built upon robust estimators of distribution locations (medians, Hodges-Lehmann estimators, and an extended U statistic) with both unscaled and scaled versions. The nonparametric tests are robust to outliers and do not assume that the two samples are drawn from multivariate normal distributions. Bootstrap and permutation approaches are introduced for determining the p-values of the proposed test statistics. Simulation studies are conducted and numerical results are reported to examine performance of ...


A Checklist For Clinical Trials In Rare Disease: Obstacles And Anticipatory Actions-Lessons Learned From The For-Dmd Trial, R Crow, K Hart, M McDermott, R Tawil, W Martens, Mathula Thangarajh, +several additional authors 2018 George Washington University

A Checklist For Clinical Trials In Rare Disease: Obstacles And Anticipatory Actions-Lessons Learned From The For-Dmd Trial, R Crow, K Hart, M Mcdermott, R Tawil, W Martens, Mathula Thangarajh, +Several Additional Authors

Neurology Faculty Publications

Background: Trials in rare diseases have many challenges, among which are the need to set up multiple sites in different countries to achieve recruitment targets and the divergent landscape of clinical trial regulations in those countries. Over the past years, there have been initiatives to facilitate the process of international study set-up, but the fruits of these deliberations require time to be operationally in place. FOR-DMD (Finding the Optimum Steroid Regimen for Duchenne Muscular Dystrophy) is an academic-led clinical trial which aims to find the optimum steroid regimen for Duchenne muscular dystrophy, funded by the National Institutes of Health (NIH ...


Simulations For Designing And Interpreting Intervention Trials In Infectious Diseases., M Elizabeth Halloran, Kari Auranen, Sarah Baird, Nicole E Basta, Steven E Bellan, +several additional authors 2017 George Washington University

Simulations For Designing And Interpreting Intervention Trials In Infectious Diseases., M Elizabeth Halloran, Kari Auranen, Sarah Baird, Nicole E Basta, Steven E Bellan, +Several Additional Authors

Global Health Faculty Publications

BACKGROUND: Interventions in infectious diseases can have both direct effects on individuals who receive the intervention as well as indirect effects in the population. In addition, intervention combinations can have complex interactions at the population level, which are often difficult to adequately assess with standard study designs and analytical methods.

DISCUSSION: Herein, we urge the adoption of a new paradigm for the design and interpretation of intervention trials in infectious diseases, particularly with regard to emerging infectious diseases, one that more accurately reflects the dynamics of the transmission process. In an increasingly complex world, simulations can explicitly represent transmission dynamics ...


Impact Of Tocilizumab Monotherapy On Clinical And Patient-Reported Quality-Of-Life Outcomes In Patients With Rheumatoid Arthritis, Leslie R. Harrold, Ani John, George W. Reed, Tmirah Haselkorn, Chitra Karki, YouFu Li, Jennie Best, Steve Zlotnick, Joel M. Kremer, Jeffrey D. Greenberg 2017 University of Massachusetts Medical School

Impact Of Tocilizumab Monotherapy On Clinical And Patient-Reported Quality-Of-Life Outcomes In Patients With Rheumatoid Arthritis, Leslie R. Harrold, Ani John, George W. Reed, Tmirah Haselkorn, Chitra Karki, Youfu Li, Jennie Best, Steve Zlotnick, Joel M. Kremer, Jeffrey D. Greenberg

Open Access Articles

INTRODUCTION: Tocilizumab (TCZ) monotherapy has been proven as an effective treatment for rheumatoid arthritis (RA) in clinical trials. However, there are limited data available regarding the effectiveness of TCZ monotherapy in real-world clinical settings in the United States. The objective of this study was to evaluate the impact of TCZ monotherapy on disease activity and patient-reported outcomes (PROs) in a US-based observational cohort of patients with RA seen in routine clinical practice.

METHODS: Eligible patients had active RA, no prior use of TCZ, and initiated TCZ as monotherapy. Changes in disease activity and PROs were assessed 1 year after TCZ ...


Infection Rates In Patients From Five Rheumatoid Arthritis (Ra) Registries: Contextualising An Ra Clinical Trial Programme, Hisashi Yamanaka, George W. Reed 2017 Tokyo Women's Medical University

Infection Rates In Patients From Five Rheumatoid Arthritis (Ra) Registries: Contextualising An Ra Clinical Trial Programme, Hisashi Yamanaka, George W. Reed

Open Access Articles

OBJECTIVE: Patients with rheumatoid arthritis (RA) have an increased risk of serious infections. Comparing infection rates across RA populations is complicated by differences in background infection risk, population composition and study methodology. We measured infection rates from five RA registries globally, with the aim to contextualise infection rates from an RA clinical trials population.

METHODS: We used data from Consortium of Rheumatology Research of North America (CORRONA) (USA), Swedish Rheumatology Quality of Care Register (Sweden), Norfolk Arthritis Register (UK), CORRONA International (multiple countries) and Institute of Rheumatology Rheumatoid Arthritis (Japan) and an RA clinical trial programme (fostamatinib). Within each registry ...


Reducing Therapeutic Misconception: A Randomized Intervention Trial In Hypothetical Clinical Trials, Paul P. Christopher, Paul S. Appelbaum, Debbie Truong, Karen Albert, Louise S. Maranda, Charles W. Lidz 2017 Brown University

Reducing Therapeutic Misconception: A Randomized Intervention Trial In Hypothetical Clinical Trials, Paul P. Christopher, Paul S. Appelbaum, Debbie Truong, Karen Albert, Louise S. Maranda, Charles W. Lidz

Open Access Articles

BACKGROUND: Participants in clinical trials frequently fail to appreciate key differences between research and clinical care. This phenomenon, known as therapeutic misconception, undermines informed consent to clinical research, but to date there have been no effective interventions to reduce it and concerns have been expressed that to do so might impede recruitment. We determined whether a scientific reframing intervention reduces therapeutic misconception without significantly reducing willingness to participate in hypothetical clinical trials.

METHODS: This prospective randomized trial was conducted from 2015 to 2016 to test the efficacy of an informed consent intervention based on scientific reframing compared to a traditional ...


Novel Bayesian Adaptive Clinical Trial Designs In Early Phases, Haitao Pan 2017 The University of Texas MD Anderson Cancer Center UTHealth Graduate School of Biomedical Sciences

Novel Bayesian Adaptive Clinical Trial Designs In Early Phases, Haitao Pan

UT GSBS Dissertations and Theses (Open Access)

Early phase, or phase I and phase II, trials are the first step in testing new medicines that have been developed in the lab. The main goal of phase I clinical trials is to establish the recommended dose of new drugs for phase II trials. For the cytotoxic drugs, the goal is to find maximum tolerated dose (MTD). The guiding principle for dose escalation in phase I trials is to avoid exposing too many patients to subtherapeutic doses while preserving safety and maintaining rapid accrual. Therefore, dose escalation methods, especially Bayesian designs, are recommended to be used in phase I ...


Burden Of Atopic Dermatitis In The United States: Analysis Of Healthcare Claims Data In The Commercial, Medicare, And Medi-Cal Databases, Sulena Shrestha, Raymond Miao, Li Wang, Jingdong Chao, Huseyin Yuce, Wenhui Wei 2017 STATinMED Research/SIMR, Inc.

Burden Of Atopic Dermatitis In The United States: Analysis Of Healthcare Claims Data In The Commercial, Medicare, And Medi-Cal Databases, Sulena Shrestha, Raymond Miao, Li Wang, Jingdong Chao, Huseyin Yuce, Wenhui Wei

Publications and Research

Comparative data on the burden of atopic dermatitis (AD) in adults relative to the general population are limited. We performed a large-scale evaluation of the burden of disease among US adults with AD relative to matched non-AD controls, encompassing comorbidities, healthcare resource utilization (HCRU), and costs, using healthcare claims data. The impact of AD disease severity on these outcomes was also evaluated.


The Importance Of Inhaler Technique In Measuring And Calculating Inhaler Adherence, And Its Clinical Outcomes, Imran Sulaiman 2017 Royal College of Surgeons in Ireland

The Importance Of Inhaler Technique In Measuring And Calculating Inhaler Adherence, And Its Clinical Outcomes, Imran Sulaiman

PhD theses

Depending on the population studied, cross-sectional observational studies suggest that between 14%-90% of patients do not use their pressurized metered dose inhaler correctly, while 50-60% misuse a dry powder inhaler. This means that unless incorrect technique is acounted for a significant underestimation of how much medication the person actually obtained may be made.

The aim of this thesis was to objectively determine the frequency and importance of inhaler technique errors and to combine these with inhaler use to provide an acurate method of calculating adherence. I then investigated different patterns of inhaler use, determinants of inhaler use and the ...


Evaluation Of Multiple Interventions Using A Stepped Wedge Design, Vivian H. Lyons, Lingyu Li, James Hughes, Ali Rowhani-Rahbar 2017 University of Washington - Seattle Campus

Evaluation Of Multiple Interventions Using A Stepped Wedge Design, Vivian H. Lyons, Lingyu Li, James Hughes, Ali Rowhani-Rahbar

UW Biostatistics Working Paper Series

Background: Stepped wedge cluster randomized trials are a class of unidirectional crossover studies that have historically been limited to evaluating a single intervention. This design is especially suitable for pragmatic trials where the study feasibility can be improved with a phased introduction of the intervention. We examined variations of stepped wedge designs that would support evaluation of multiple interventions. Methods: We propose four different design variants for implementing a stepped wedge trial with two interventions: concurrent design, supplementation, replacement, and factorial designs. Analyses were conducted comparing the precision of the estimated intervention effects for the different designs. Results: Concurrent, supplementation ...


Treatment Pathway Of Bone Sarcoma In Children, Adolescents, And Young Adults, Damon R. Reed, Masanori Hayashi, Lars M. Wagner, Odion Binitie, Diana A. Steppan, Andrew S. Brohl, Eric T. Shinohara, Julia A. Bridge, David M. Loeb, Scott C. Borinstein, Michael S. Isakoff 2017 H. Lee Moffitt Cancer Center and Research Institute

Treatment Pathway Of Bone Sarcoma In Children, Adolescents, And Young Adults, Damon R. Reed, Masanori Hayashi, Lars M. Wagner, Odion Binitie, Diana A. Steppan, Andrew S. Brohl, Eric T. Shinohara, Julia A. Bridge, David M. Loeb, Scott C. Borinstein, Michael S. Isakoff

Pediatrics Faculty Publications

When pediatric, adolescent, and young adult patients present with a bone sarcoma, treatment decisions, especially after relapse, are complex and require a multidisciplinary approach. This review presents scenarios commonly encountered in the therapy of bone sarcomas with the goal of objectively presenting a consensus, multidisciplinary management approach. Little variation was found in the authors' group with respect to local control or systemic therapy. Clinical trials were universally prioritized in all settings. Decisions regarding relapse therapies in the absence of a clinical trial had very minor variations initially, but a consensus was reached after a literature review and discussion. This review ...


Randomized Clinical Trial To Evaluate The Pathogenicity Of Bibersteinia Trehalosi In Respiratory Disease Among Calves, Christy Jo Hanthorn, Reneé Dewell, Vickie L. Cooper, Timothy S. Frana, Paul J. Plummer, Chong Wang, Grant A. Dewell 2017 Iowa State University

Randomized Clinical Trial To Evaluate The Pathogenicity Of Bibersteinia Trehalosi In Respiratory Disease Among Calves, Christy Jo Hanthorn, Reneé Dewell, Vickie L. Cooper, Timothy S. Frana, Paul J. Plummer, Chong Wang, Grant A. Dewell

Grant A. Dewell

Bibersteinia trehalosi causes respiratory disease in ruminants particularly in wild and domestic sheep. Recently, there has been an increased number of B. trehalosi isolates obtained from diagnostic samples from bovine respiratory disease cases. This study evaluated the role of B. trehalosi in bovine respiratory disease using an intra-tracheal inoculation model in calves. Thirty six cross bred 2–3 month old dairy calves were inoculated intra-tracheally with either leukotoxin negative B. trehalosi, leukotoxin positive B. trehalosi isolate, Mannheimia haemolytica, a combination of leukotoxin negative B. trehalosi and M. haemolytica or negative control. Calves were euthanized and necropsy performed on day 10 ...


Safety And Immunogenicity Of An Inactivated Whole Cell Tuberculosis Vaccine Booster In Adults Primed With Bcg: A Randomized, Controlled Trial Of Dar-901, C. Fordham von Reyn, Timothy Lahey, Robert D. Arbeit, Bernard Landry, Leway Kailani, Lisa Adams, Brenda Haynes, Todd Mackenzie, Wendy Wieland-Alter, Ruth Connor, Sue Tvaroha, David Hokey, Ann Ginsberg, Richard Waddell 2017 Dartmouth College

Safety And Immunogenicity Of An Inactivated Whole Cell Tuberculosis Vaccine Booster In Adults Primed With Bcg: A Randomized, Controlled Trial Of Dar-901, C. Fordham Von Reyn, Timothy Lahey, Robert D. Arbeit, Bernard Landry, Leway Kailani, Lisa Adams, Brenda Haynes, Todd Mackenzie, Wendy Wieland-Alter, Ruth Connor, Sue Tvaroha, David Hokey, Ann Ginsberg, Richard Waddell

Open Dartmouth: Faculty Open Access Articles

Development of a tuberculosis vaccine to boost BCG is a major international health priority. SRL172, an inactivated whole cell booster derived from a non-tuberculous mycobacterium, is the only new vaccine against tuberculosis to have demonstrated efficacy in a Phase 3 trial. In the present study we sought to determine if a three-dose series of DAR-901 manufactured from the SRL172 master cell bank by a new, scalable method was safe and immunogenic.


Denoising Tandem Mass Spectrometry Data, Felix Offei 2017 East Tennessee State Universtiy

Denoising Tandem Mass Spectrometry Data, Felix Offei

Electronic Theses and Dissertations

Protein identification using tandem mass spectrometry (MS/MS) has proven to be an effective way to identify proteins in a biological sample. An observed spectrum is constructed from the data produced by the tandem mass spectrometer. A protein can be identified if the observed spectrum aligns with the theoretical spectrum. However, data generated by the tandem mass spectrometer are affected by errors thus making protein identification challenging in the field of proteomics. Some of these errors include wrong calibration of the instrument, instrument distortion and noise. In this thesis, we present a pre-processing method, which focuses on the removal of ...


Polymer Micelle Formulation For The Proteasome Inhibitor Drug Carfilzomib: Anticancer Efficacy And Pharmacokinetic Studies In Mice, Ji Eun Park, Se-Eun Chun, Derek Alexander Reichel, Jee Sun Min, Su-Chan Lee, Songhee Han, Gongmi Ryoo, Yunseok Oh, Shin-Hyung Park, Heon-Min Ryu, Kyung Bo Kim, Ho-Young Lee, Soo Kyung Bae, Younsoo Bae, Wooin Lee 2017 Seoul National University, South Korea

Polymer Micelle Formulation For The Proteasome Inhibitor Drug Carfilzomib: Anticancer Efficacy And Pharmacokinetic Studies In Mice, Ji Eun Park, Se-Eun Chun, Derek Alexander Reichel, Jee Sun Min, Su-Chan Lee, Songhee Han, Gongmi Ryoo, Yunseok Oh, Shin-Hyung Park, Heon-Min Ryu, Kyung Bo Kim, Ho-Young Lee, Soo Kyung Bae, Younsoo Bae, Wooin Lee

Pharmaceutical Sciences Faculty Publications

Carfilzomib (CFZ) is a peptide epoxyketone proteasome inhibitor approved for the treatment of multiple myeloma (MM). Despite the remarkable efficacy of CFZ against MM, the clinical trials in patients with solid cancers yielded rather disappointing results with minimal clinical benefits. Rapid degradation of CFZ in vivo and its poor penetration to tumor sites are considered to be major factors limiting its efficacy against solid cancers. We previously reported that polymer micelles (PMs) composed of biodegradable block copolymers poly(ethylene glycol) (PEG) and poly(caprolactone) (PCL) can improve the metabolic stability of CFZ in vitro. Here, we prepared the CFZ-loaded PM ...


Effect Of Immediate Initiation Of Antiretroviral Therapy On Risk Of Severe Bacterial Infections In Hiv-Positive People With Cd4 Cell Counts Of More Than 500 Cells Per Μl: Secondary Outcome Results From A Randomised Controlled Trial., Jemma O'Connor, Michael J Vjecha, Andrew N Phillips, Brian Angus, David Cooper, Fred Gordin, +several additional authors 2017 George Washington University

Effect Of Immediate Initiation Of Antiretroviral Therapy On Risk Of Severe Bacterial Infections In Hiv-Positive People With Cd4 Cell Counts Of More Than 500 Cells Per Μl: Secondary Outcome Results From A Randomised Controlled Trial., Jemma O'Connor, Michael J Vjecha, Andrew N Phillips, Brian Angus, David Cooper, Fred Gordin, +Several Additional Authors

Medicine Faculty Publications

BACKGROUND: The effects of antiretroviral therapy on risk of severe bacterial infections in people with high CD4 cell counts have not been well described. In this study, we aimed to quantify the effects of immediate versus deferred ART on the risk of severe bacterial infection in people with high CD4 cell counts in a preplanned analysis of the START trial.

METHODS: The START trial was a randomised controlled trial in ART-naive HIV-positive patients with CD4 cell count of more than 500 cells per μL assigned to immediate ART or deferral until their CD4 cell counts were lower than 350 cells ...


Adaptive Non-Inferiority Margins Under Observable Non-Constancy, Brett S. Hanscom, Deborah J. Donnell, Brian D. Williamson, Jim Hughes 2017 Fred Hutchinson Cancer Research Center

Adaptive Non-Inferiority Margins Under Observable Non-Constancy, Brett S. Hanscom, Deborah J. Donnell, Brian D. Williamson, Jim Hughes

UW Biostatistics Working Paper Series

A central assumption in the design and conduct of non-inferiority trials is that the active-control therapy will have the same degree of effectiveness in the planned non-inferiority trial as it had in the prior placebo-controlled trials used to define the non-inferiority margin. This is referred to as the `constancy' assumption. If the constancy assumption fails, the chosen non-inferiority margin is not valid and the study runs the risk of approving an inferior product or failing to approve a beneficial product. The constancy assumption cannot be validated in a trial without a placebo arm, and it is unlikely ever to be ...


A Comparison Of The Quality Of Informed Consent For Clinical Trials Of An Experimental Hookworm Vaccine Conducted In Developed And Developing Countries., David J. Diemert, Lucas Lobato, Ashley Styczynski, Maria Zumer, Amanda Soares, Maria Flávia Gazzinelli 2017 George Washington University

A Comparison Of The Quality Of Informed Consent For Clinical Trials Of An Experimental Hookworm Vaccine Conducted In Developed And Developing Countries., David J. Diemert, Lucas Lobato, Ashley Styczynski, Maria Zumer, Amanda Soares, Maria Flávia Gazzinelli

Microbiology, Immunology, and Tropical Medicine Faculty Publications

Informed consent is one of the principal ethical requirements of conducting clinical research, regardless of the study setting. Breaches in the quality of the informed consent process are frequently described in reference to clinical trials conducted in developing countries, due to low levels of formal education, a lack of familiarity with biomedical research, and limited access to health services in these countries. However, few studies have directly compared the quality of the informed consent process in developed and developing countries using the same tool and in similar clinical trials. This study was conducted to compare the quality of the informed ...


Digital Commons powered by bepress