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

Clinical Trials Commons

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

176 Full-Text Articles 598 Authors 52,538 Downloads 30 Institutions

All Articles in Clinical Trials

Faceted Search

176 full-text articles. Page 3 of 6.

Update On Schizophrenia And Bipolar Disorder: Focus On Cariprazine, Rona Jeannie Roberts, Lillian Jan Findlay, Peggy El-Mallakh, Rif S. El-Mallakh 2016 University of Louisville

Update On Schizophrenia And Bipolar Disorder: Focus On Cariprazine, Rona Jeannie Roberts, Lillian Jan Findlay, Peggy El-Mallakh, Rif S. El-Mallakh

Nursing Faculty Publications

Schizophrenia and bipolar disorder are severe psychiatric disorders that are frequently associated with persistent symptoms and significant dysfunction. While there are a multitude of psychopharmacologic agents are available for treatment of these illnesses, suboptimal response and significant adverse consequences limit their utility. Cariprazine is a new, novel antipsychotic medication with dopamine D2 and D3 partial agonist effects. Its safety and efficacy have been investigated in acute psychosis of schizophrenia, bipolar mania, bipolar depression, and unipolar depression. Efficacy has been demonstrated in schizophrenia and mania. It is unclear if cariprazine is effective in depression associated with unipolar or bipolar illness. Adverse ...


A Randomized, Double-Blind, Placebo-Controlled Phase Ii Trial Investigating The Safety And Immunogenicity Of Modified Vaccinia Ankara Smallpox Vaccine (Mva-Bn®) In 56-80-Year-Old Subjects, Richard N. Greenberg, Christine M. Hay, Jack T. Stapleton, Thomas C. Marbury, Eva Wagner, Eva Kreitmeir, Siegfried Röesch, Alfred von Krempelhuber, Philip Young, Richard Nichols, Thomas P. Meyer, Darja Schmidt, Josef Weigl, Garth Virgin, Nathaly Arndtz-Wiedemann, Paul Chaplin 2016 University of Kentucky

A Randomized, Double-Blind, Placebo-Controlled Phase Ii Trial Investigating The Safety And Immunogenicity Of Modified Vaccinia Ankara Smallpox Vaccine (Mva-Bn®) In 56-80-Year-Old Subjects, Richard N. Greenberg, Christine M. Hay, Jack T. Stapleton, Thomas C. Marbury, Eva Wagner, Eva Kreitmeir, Siegfried Röesch, Alfred Von Krempelhuber, Philip Young, Richard Nichols, Thomas P. Meyer, Darja Schmidt, Josef Weigl, Garth Virgin, Nathaly Arndtz-Wiedemann, Paul Chaplin

Internal Medicine Faculty Publications

Background Modified Vaccinia Ankara MVA-BN® is a live, highly attenuated, viral vaccine under advanced development as a non-replicating smallpox vaccine. In this Phase II trial, the safety and immunogenicity of Modified Vaccinia Ankara MVA-BN® (MVA) was assessed in a 56–80 years old population.

Methods MVA with a virus titer of 1 x 108 TCID50/dose was administered via subcutaneous injection to 56–80 year old vaccinia-experienced subjects (N = 120). Subjects received either two injections of MVA (MM group) or one injection of Placebo and one injection of MVA (PM group) four weeks apart. Safety was evaluated by ...


Is The Force Awakened? Publication Trends In Oncology Big Data As Phase Ii Cancerlinq Is Launched, Hind Rafei, Benjamin Viernes, Angelike P. Liappis, Dalia Abdelaziz Mobarek 2016 George Washington University

Is The Force Awakened? Publication Trends In Oncology Big Data As Phase Ii Cancerlinq Is Launched, Hind Rafei, Benjamin Viernes, Angelike P. Liappis, Dalia Abdelaziz Mobarek

GW Research Days 2016 - Present

Background: The American Society of Clinical Oncology launched CancerLinQ project in 2010 to provide real-time data collection, mining and visualization, clinical decision support, and quality feedback. Creation of a big data software platform is currently underway to power the CancerLinQ in the phase II of the project. This would allow for evidence driven practice and rapid learning for cancer care providers. Additionally, adequate knowledge about the utility of Big Data to encourage provider utilization in high Impact Factor (IF) journals is needed. We aimed to assess trends and quality of Big Data published in Oncology.

Methods: Peer-reviewed English papers published ...


Models For Hsv Shedding Must Account For Two Levels Of Overdispersion, Amalia Magaret 2016 University of Washington - Seattle Campus

Models For Hsv Shedding Must Account For Two Levels Of Overdispersion, Amalia Magaret

UW Biostatistics Working Paper Series

We have frequently implemented crossover studies to evaluate new therapeutic interventions for genital herpes simplex virus infection. The outcome measured to assess the efficacy of interventions on herpes disease severity is the viral shedding rate, defined as the frequency of detection of HSV on the genital skin and mucosa. We performed a simulation study to ascertain whether our standard model, which we have used previously, was appropriately considering all the necessary features of the shedding data to provide correct inference. We simulated shedding data under our standard, validated assumptions and assessed the ability of 5 different models to reproduce the ...


The Myth Of Making Inferences For An Overall Treatment Efficacy With Data From Multiple Comparative Studies Via Meta-Analysis, Takahiro Hasegawa, Brian Claggett, Lu Tian, Scott D. Solomon, Marc A. Pfeffer, Lee-Jen Wei 2016 Shionogi & Co., Ltd.

The Myth Of Making Inferences For An Overall Treatment Efficacy With Data From Multiple Comparative Studies Via Meta-Analysis, Takahiro Hasegawa, Brian Claggett, Lu Tian, Scott D. Solomon, Marc A. Pfeffer, Lee-Jen Wei

Harvard University Biostatistics Working Paper Series

Meta analysis techniques, if applied appropriately, can provide a summary of the totality of evidence regarding an overall difference between a new treatment and a control group using data from multiple comparative clinical studies. The standard meta analysis procedures, however, may not give a meaningful between-group difference summary measure or identify a meaningful patient population of interest, especially when the fixed effect model assumption is not met. Moreover, a single between-group comparison measure without a reference value obtained from patients in the control arm would likely not be informative enough for clinical decision making. In this paper, we propose a ...


Missing Data In Clinical Trial: A Critical Look At The Proportionality Of Mnar And Mar Assumptions For Multiple Imputation, Theophile B. Dipita 2016 Georgia Southern University

Missing Data In Clinical Trial: A Critical Look At The Proportionality Of Mnar And Mar Assumptions For Multiple Imputation, Theophile B. Dipita

Electronic Theses and Dissertations

Randomized control trial is a gold standard of research studies. Randomization helps reduce bias and infer causality. One constraint of these studies is that it depends on participants to obtain the desired data. Whatever the researcher can do, there is a possibility to end up with incomplete data. The problem is more relevant in clinical trials when missing data can be related to the condition under study. The benefits of randomization is compromised by missing data. Multiple imputation is a valid method of treating missing data under the assumption of MAR. Unfortunately this is an unverified assumptions. Current practice advise ...


Hyperoxia Increases Arterial Oxygen Pressure During Exercise In Type 2 Diabetes Patients: A Feasibility Study, Robert Rozenberg, Robert T. Mankowski, Luc van Loon, Janneke G. Langendonk, Eric J. G. Sijbrands, Anton H. van den Meiracker, Henk J. Stam, Stephan F. E. Praet 2016 Australian Catholic University

Hyperoxia Increases Arterial Oxygen Pressure During Exercise In Type 2 Diabetes Patients: A Feasibility Study, Robert Rozenberg, Robert T. Mankowski, Luc Van Loon, Janneke G. Langendonk, Eric J. G. Sijbrands, Anton H. Van Den Meiracker, Henk J. Stam, Stephan F. E. Praet

Faculty of Health Sciences Publications

Objective: The study investigated the feasibility and potential outcome measures during acute hyperoxia in type 2 diabetes patients ( DM2 ). Methods: Eleven DM2 patients ( 7 men and 4 women ) were included in the study. The patients cycled ( 30 min at 20 % Wmax ) whilst breathing three different supplemental oxygen flows ( SOF, 5, 10, 15 L min−1 ). During hyperoxic exercise, arterial blood gases and intra-arterial blood pressure measurements were obtained. Results: Arterial pO2 levels increased significantly ( ANOVA, p < 0.05 ) with SOF: 13.9 ± 1.2 ( 0 L min−1 ); 18.5 ± 1.5 ( 5 L min−1 ); 21.7 ± 1.7 ( 10 L min−1 ); 24.0 ± 2.3 ( 15 L min−1 ). Heart rate ( HR ) and pH increased significantly after terminating administration of hyperoxic air. Conclusions: An SOF of 15 L min−1 appears to be more effective than 5 or 10 L min−1. Moreover, HR, blood pressure, blood lactate and pH are not recommended as primary outcome measures.


Simulations Of A New Response-Adaptive Biased Coin Design, Aleksandra Stein 2015 University of Nebraska-Lincoln

Simulations Of A New Response-Adaptive Biased Coin Design, Aleksandra Stein

Dissertations and Theses in Statistics

Modern medical experiments accrue and treat patients--hence obtain treatment response data--throughout a trial. Designs which prospectively plan to modify patient allocation by leveraging accumulating data are response-adaptive randomization (RAR) designs. Many such designs attempt to balance the desire to bias assignment proportions towards a treatment which is performing better against the need to maintain randomization in the face of continued equipoise.

This dissertation consists of simulated investigations into frequentist and ethical properties of an new RAR biased coin design. Chapter 2 proposes a new adaptive design for phase III clinical trials, a modification of the 2001 Bandyopadhyay and Biswas biased ...


C-Learning: A New Classification Framework To Estimate Optimal Dynamic Treatment Regimes, Baqun Zhang, Min Zhang 2015 Renmin University of China, School of Statistics

C-Learning: A New Classification Framework To Estimate Optimal Dynamic Treatment Regimes, Baqun Zhang, Min Zhang

The University of Michigan Department of Biostatistics Working Paper Series

Personalizing treatment to accommodate patient heterogeneity and the evolving nature of a disease over time has received considerable attention lately. A dynamic treatment regime is a set of decision rules, each corresponding to a decision point, that determine that next treatment based on each individual’s own available characteristics and treatment history up to that point. We show that identifying the optimal dynamic treatment regime can be recast as a sequential classification problem and is equivalent to sequentially minimizing a weighted expected misclassification error. This general classification perspective targets the exact goal of optimally individualizing treatments and is new and ...


Assessing Usual Care In Clinical Trials, Judith A. Erlen, Lisa K. Tamres, Nancy Reynolds, Carol E. Golin, Marc I. Rosen, Robert H. Remien, Julie W. Banderas, Neil Schneiderman, Glenn Wagner, David Bangsberg, Honghu Liu 2015 University of Pittsburgh School of Nursing

Assessing Usual Care In Clinical Trials, Judith A. Erlen, Lisa K. Tamres, Nancy Reynolds, Carol E. Golin, Marc I. Rosen, Robert H. Remien, Julie W. Banderas, Neil Schneiderman, Glenn Wagner, David Bangsberg, Honghu Liu

OHSU-PSU School of Public Health Faculty Publications and Presentations

Researchers designing clinical trials often specify usual care received by participants as the control condition expecting that all participants receive usual care regardless of group assignment. The assumption is that the groups in the study are affected similarly. We describe the assessment of usual care within the 16 studies in MACH 14, a multi-site collaboration on adherence to antiretroviral therapy. Only five of the studies in MACH 14 assessed usual care. Assessment protocols varied as did the timing and frequency of assessments. All usual care assessments addressed patient education focused on HIV, HIV medications, and medication adherence. Our findings support ...


Gene Expression Changes Reflect Clinical Response In A Placebo-Controlled Randomized Trial Of Abatacept In Patients With Diffuse Cutaneous Systemic Sclerosis, Eliza F. Chakravarty, Viktor Martyanov, David Fiorentino, Tammara A. Wood, David J. Haddon, Justin A. Jarrell, Paul Utz, Mark Genovese, Michael Whitfield, Lorinda Chung 2015 Oklahoma Medical Research Foundation

Gene Expression Changes Reflect Clinical Response In A Placebo-Controlled Randomized Trial Of Abatacept In Patients With Diffuse Cutaneous Systemic Sclerosis, Eliza F. Chakravarty, Viktor Martyanov, David Fiorentino, Tammara A. Wood, David J. Haddon, Justin A. Jarrell, Paul Utz, Mark Genovese, Michael Whitfield, Lorinda Chung

Open Dartmouth: Faculty Open Access Articles

Systemic sclerosis is an autoimmune disease characterized by inflammation and fibrosis of the skin and internal organs. We sought to assess the clinical and molecular effects associated with response to intravenous abatacept in patients with diffuse cutaneous systemic.


A Novel Multi-Tissue Rna Diagnostic Of Healthy Ageing Relates To Cognitive Health Status, Sanjana Sood, Iain J. Gallagher, Katie Lunnon, Eric Rullman, Aoife Keohane, Hannah Crossland, Bethan E. Phillips, Tommy Cederholm, Thomas E. Jensen, Luc J. C. van Loon, Lars Lannfelt, William E. Kraus, Philip J. Atherton, Robert Howard, Thomas Gustafsson, Angela Hodges, James A. Timmons 2015 Australian Catholic University

A Novel Multi-Tissue Rna Diagnostic Of Healthy Ageing Relates To Cognitive Health Status, Sanjana Sood, Iain J. Gallagher, Katie Lunnon, Eric Rullman, Aoife Keohane, Hannah Crossland, Bethan E. Phillips, Tommy Cederholm, Thomas E. Jensen, Luc J. C. Van Loon, Lars Lannfelt, William E. Kraus, Philip J. Atherton, Robert Howard, Thomas Gustafsson, Angela Hodges, James A. Timmons

Faculty of Health Sciences Publications

Background: Diagnostics of the human ageing process may help predict future healthcare needs or guide preventative measures for tackling diseases of older age. We take a transcriptomics approach to build the first reproducible multi-tissue RNA expression signature by gene-chip profiling tissue from sedentary normal subjects who reached 65 years of age in good health. Results: One hundred and fifty probe-sets form an accurate classifier of young versus older muscle tissue and this healthy ageing RNA classifier performed consistently in independent cohorts of human muscle, skin and brain tissue ( n = 594, AUC = 0.83–0.96 ) and thus represents a biomarker ...


The Effect Of Exercise Training On The Course Of Cardiac Troponin T And I Levels: Three Independent Training Studies, Noreen van der Linden, Lieke J. J. Klinkenberg, Marika Leenders, Michael Tieland, Lex B. Verdijk, Marijke Niens, Jeroen D. E. van Suijlen, Lisette C. P. G. M. de Groot, Otto Bekers, Luc J. C. van Loon, Marja P. van Dieijen-Visser, Steven J. R. Meex 2015 Australian Catholic University

The Effect Of Exercise Training On The Course Of Cardiac Troponin T And I Levels: Three Independent Training Studies, Noreen Van Der Linden, Lieke J. J. Klinkenberg, Marika Leenders, Michael Tieland, Lex B. Verdijk, Marijke Niens, Jeroen D. E. Van Suijlen, Lisette C. P. G. M. De Groot, Otto Bekers, Luc J. C. Van Loon, Marja P. Van Dieijen-Visser, Steven J. R. Meex

Faculty of Health Sciences Publications

With the introduction of high-sensitive assays, cardiac troponins became potential biomarkers for risk stratification and prognostic medicine. Observational studies have reported an inverse association between physical activity and basal cardiac troponin levels. However, causality has never been demonstrated. This study investigated whether basal cardiac troponin concentrations are receptive to lifestyle interventions such as exercise training. Basal high-sensitive cardiac troponin T ( cTnT ) and I ( cTnI ) were monitored in two resistance-type exercise training programs ( 12-week ( study 1 ) and 24-week ( study 2 ) ) in older adults ( ≥65 years ). In addition, a retrospective analysis for high sensitive troponin I in a 24-week exercise controlled trial ...


A Review Of Frequentist Tests For The 2x2 Binomial Trial, Chris Lloyd 2014 Melbourne Business School

A Review Of Frequentist Tests For The 2x2 Binomial Trial, Chris Lloyd

Chris J. Lloyd

The 2x2 binomial trial is the simplest of data structures yet its statistical analysis and the issues it raises have been debated and revisited for over 70 years. Which analysis should biomedical researchers use in applications? In this review, we consider frequentist tests only, specifically tests with control size either exactly or very close to exactly. These procedures can be classified as conditional and unconditional. Amongst tests motivated by a conditional model, Lancaster’s mid-p and Liebermeister’s test are less conservative than Fisher’s classical test, but do not control type 1 error. Within the conditional framework, only Fisher ...


Prognostic And Predictive Directions For Clinical Trials, Debashis Ghosh 2014 University of Colorado Denver

Prognostic And Predictive Directions For Clinical Trials, Debashis Ghosh

Debashis Ghosh

In many clinical trials, treatment effects can be quite heterogeneous across subgroups so that individuals in different subgroups can receive different benefits of the treatment. This can be quite important for the purposes of clinical decision-making purposes. In this article, we introduce a general concept of risk score that is motivated by potential outcomes consider- ations. The concepts of prognostic and predictive directions for outcome data are defined. Their basis is in the dimension reduction (DR) literature and can also be motivated by con- ditional independence assumptions. Under some conditions, one can use existing methods from the DR literature to ...


Factors That Impact Patient Enrollment In Clinical Trials, Phong Duong B.A. 2014 University of North Texas Health Science Center at Fort Worth

Factors That Impact Patient Enrollment In Clinical Trials, Phong Duong B.A.

Theses and Dissertations

Introduction: Medical progress, now more than ever, demands clinicians to provide tangible proof over sound hypotheses. This is where clinical research steps in as a combatant to the unknown provoked by logical theories and sound hypotheses. The one constant in clinical research is that recruitment strategies are always changing. Analyzing factors that impact recruitment will effectively serve to improve the quality of clinical research conduction.

Objective: The purpose of this project is to determine if there are certain factors in an individual’s life that has influenced them to participate in a clinical research study.

Methods: To address the specific ...


Wordless Intervention For Epilepsy In Learning Disabilities (Wield): Study Protocol For A Randomized Controlled Feasibility Trial, Marie-Anne Durand, Bob Gates, Georgina Parkes, Asif Zia 2014 Dartmouth College

Wordless Intervention For Epilepsy In Learning Disabilities (Wield): Study Protocol For A Randomized Controlled Feasibility Trial, Marie-Anne Durand, Bob Gates, Georgina Parkes, Asif Zia

Open Dartmouth: Faculty Open Access Articles

Epilepsy is the most common neurological problem that affects people with learning disabilities. The high seizure frequency, resistance to treatments, associated skills deficit and co-morbidities make the management of epilepsy particularly challenging for people with learning disabilities. The Books Beyond Words booklet for epilepsy uses images to help people with learning disabilities manage their condition and improve quality of life. Our aim is to conduct a randomized controlled feasibility trial exploring key methodological, design and acceptability issues, in order to subsequently undertake a large-scale randomized controlled trial of the Books Beyond Words booklet for epilepsy.


Volunteer Studies In Pain Research — Opportunities And Challenges To Replace Animal Experiments: The Report And Recommendations Of A Focus On Alternatives Workshop, C. K. Langley, Q. Aziz, C. Bountra, N. Gordon, P. Hawkins, A. Jones, G. Langley, T. Nurmikko, I. Tracey 2014 Wingate Institute of Neurogastroenterology

Volunteer Studies In Pain Research — Opportunities And Challenges To Replace Animal Experiments: The Report And Recommendations Of A Focus On Alternatives Workshop, C. K. Langley, Q. Aziz, C. Bountra, N. Gordon, P. Hawkins, A. Jones, G. Langley, T. Nurmikko, I. Tracey

Gill Langley, Ph.D.

Despite considerable research, effective and safe treatments for human pain disorders remain elusive. Understanding the biology of different human pain conditions and researching effective treatments continue to be dominated by animal models, some of which are of limited value. British and European legislation demands that non-animal approaches should be considered before embarking on research using experimental animals. Recent scientific and technical developments, particularly in human neuroimaging, offer the potential to replace some animal procedures in the study of human pain. A group of pain research experts from academia and industry met with the aim of exploring creatively the tools, strategies ...


Depicting Estimates Using The Intercept In Meta-Regression Models: The Moving Constant Technique, Blair T. Johnson Dr., Tania B. Huedo-Medina Dr. 2014 University of Connecticut - Storrs

Depicting Estimates Using The Intercept In Meta-Regression Models: The Moving Constant Technique, Blair T. Johnson Dr., Tania B. Huedo-Medina Dr.

Blair T. Johnson

In any scientific discipline, the ability to portray research patterns graphically often aids greatly in interpreting a phenomenon. In part to depict phenomena, the statistics and capabilities of meta-analytic models have grown increasingly sophisticated. Accordingly, this article details how to move the constant in weighted meta-analysis regression models (viz. “meta-regression”) to illuminate the patterns in such models across a range of complexities. Although it is commonly ignored in practice, the constant (or intercept) in such models can be indispensible when it is not relegated to its usual static role. The moving constant technique makes possible estimates and confidence intervals at ...


Genetic Predictors Of Metabolic Side Effects Of Diuretic Therapy, Jorge L. Del Aguila 2014 The University of Texas Graduate School of Biomedical Sciences at Houston

Genetic Predictors Of Metabolic Side Effects Of Diuretic Therapy, Jorge L. Del Aguila

UT GSBS Dissertations and Theses (Open Access)

Thiazide diuretics are a recommended first-line monotherapy for hypertension (i.e.SBP>140 mmHg or DBP>90 mmHg). Even so, diuretics are associated with adverse metabolic side effects, such as hyperlipidemia, hyperglycemia and hypokalemia which increase the risk of developing type II diabetes. This thesis used three analytical strategies to identify and quantify genetic factors that contribute to the development of adverse metabolic effects due to thiazide diuretic treatment. I performed a genome-wide association study (GWAS) and meta-analysis of the change in fasting plasma glucose and triglycerides in response to HCTZ from two different clinical trials: the Pharmacogenomic Evaluation of ...


Digital Commons powered by bepress