# Clinical Trials Commons™

## All Articles in Clinical Trials

196 full-text articles. Page 1 of 7.

Tricyclic Antidepressant Use And Risk Of Fractures: A Meta-Analysis Of Cohort Studies Through The Use Of Both Frequentist And Bayesian Approaches, 2020 University of Nevada, Las Vegas

#### 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 Publications

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 ...

Searching For Covid-19 Treatments: First, Do No Harm, 2020 University of Massachusetts Medical School

#### Searching For Covid-19 Treatments: First, Do No Harm, Roy Guharoy, Edward Krenzelok

##### COVID-19 Publications by UMMS Authors

FDA is the gatekeeper to protect the public health and is critical to sustain US global leadership in drug innovation. Our foundation of evidence-based clinical practice is based on large, well-designed randomized controlled trials. The failure of HCQ against COVID-19 stands as prime example of the urgent need for adherence to science. Rigorous scientific objectivity Downloaded from https://academic.oup.com/ajhp/advance-article/doi/10.1093/ajhp/zxaa257/5879960 by Medical Center Library user on 17 August 2020 13 and independence must prevail in any future EUA decision by FDA. Trust in FDA’s mission to approve safe and effective ...

Utility Of Inflammatory Markers To Predict Adverse Outcome In Acute Pancreatitis: A Retrospective Study In A Single Academic Center, 2020 University of Nevada, Las Vegas

#### 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 Publications

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 ...

Prognostic Factors For Changes In The Timed 4-Stair Climb In Patients With Duchenne Muscular Dystrophy, And Implications For Measuring Drug Efficacy: A Multi-Institutional Collaboration, 2020 University Hospitals Leuven

#### Prognostic Factors For Changes In The Timed 4-Stair Climb In Patients With Duchenne Muscular Dystrophy, And Implications For Measuring Drug Efficacy: A Multi-Institutional Collaboration, Nathalie Goemans, Brenda L. Wong, Marleen Van Den Hauwe, James Signorovitch, Gautam Sajeev, David Cox, John Landry, Madeline Jenkins, Ibrahima Dieye, Zhiwen Yao, Intekhab Hossain, Susan J. Ward

##### Open Access Articles

The timed 4-stair climb (4SC) assessment has been used to measure function in Duchenne muscular dystrophy (DMD) practice and research. We sought to identify prognostic factors for changes in 4SC, assess their consistency across data sources, and the extent to which prognostic scores could be useful in DMD clinical trial design and analysis. Data from patients with DMD in the placebo arm of a phase 3 trial (Tadalafil DMD trial) and two real-world sources (Universitaire Ziekenhuizen, Leuven, Belgium [Leuven] and Cincinnati Children's Hospital Medical Center [CCHMC]) were analyzed. One-year changes in 4SC completion time and velocity (stairs/second) were ...

Remdesivir For The Treatment Of Covid-19 - Preliminary Report, 2020 National Institutes of Health

#### Remdesivir For The Treatment Of Covid-19 - Preliminary Report, John H. Beigel, Robert W. Finberg, Actt-1 Study Group Members

##### COVID-19 Publications by UMMS Authors

BACKGROUND: Although several therapeutic agents have been evaluated for the treatment of coronavirus disease 2019 (Covid-19), none have yet been shown to be efficacious.

METHODS: We conducted a double-blind, randomized, placebo-controlled trial of intravenous remdesivir in adults hospitalized with Covid-19 with evidence of lower respiratory tract involvement. Patients were randomly assigned to receive either remdesivir (200 mg loading dose on day 1, followed by 100 mg daily for up to 9 additional days) or placebo for up to 10 days. The primary outcome was the time to recovery, defined by either discharge from the hospital or hospitalization for infection-control purposes ...

2020 Southern Methodist University

#### Sensitivity Analysis For Incomplete Data And Causal Inference, Heng Chen

##### Statistical Science Theses and Dissertations

In this dissertation, we explore sensitivity analyses under three different types of incomplete data problems, including missing outcomes, missing outcomes and missing predictors, potential outcomes in \emph{Rubin causal model (RCM)}. The first sensitivity analysis is conducted for the \emph{missing completely at random (MCAR)} assumption in frequentist inference; the second one is conducted for the \emph{missing at random (MAR)} assumption in likelihood inference; the third one is conducted for one novel assumption, the sixth assumption'' proposed for the robustness of instrumental variable estimand in causal inference.

Survival Following Allogeneic Transplant In Patients With Myelofibrosis, 2020 University of Arizona

#### Survival Following Allogeneic Transplant In Patients With Myelofibrosis, Krisstina Gowin, Jan Cerny

##### Open Access Articles

Allogeneic hematopoietic cell transplantation (HCT) is the only curative therapy for myelofibrosis (MF). In this large multicenter retrospective study, overall survival (OS) in MF patients treated with allogeneic HCT (551 patients) and without HCT (non-HCT) (1377 patients) was analyzed with Cox proportional hazards model. Survival analysis stratified by the Dynamic International Prognostic Scoring System (DIPSS) revealed that the first year of treatment arm assignment, due to upfront risk of transplant-related mortality (TRM), HCT was associated with inferior OS compared with non-HCT (non-HCT vs HCT: DIPSS intermediate 1 [Int-1]: hazard ratio [HR] = 0.26, P < .0001; DIPSS-Int-2 and higher: HR, 0.39, P < .0001). Similarly, in the DIPSS low-risk MF group, due to upfront TRM risk, OS was superior with non-HCT therapies compared with HCT in the first-year post treatment arm assignment (HR, 0.16, P = .006). However, after 1 year, OS was not significantly different (HR, 1.38, P = .451). Beyond 1 year of treatment arm assignment, an OS advantage with HCT therapy in Int-1 and higher DIPSS score patients was observed (non-HCT vs HCT: DIPSS-Int-1: HR, 2.64, P < .0001; DIPSS-Int-2 and higher: HR, 2.55, P < .0001). In conclusion, long-term OS advantage with HCT was observed for patients with Int-1 or higher risk MF, but at the cost of early TRM. The magnitude of OS benefit with HCT increased as DIPSS risk score increased and became apparent with longer follow-up.

Real-Time Feedback For Colonoscopy In A Multicenter Clinical Trial, 2020 Iowa State University

#### Real-Time Feedback For Colonoscopy In A Multicenter Clinical Trial, Wallapak Tavanapong, Junghwan Oh, Gavin Kijkul, Jacob Pratt, Johnny Wong, Piet C. Degroen

##### Computer Science Conference Presentations, Posters and Proceedings

We report the technical challenges, solutions, and lessons learned from deploying real-time feedback systems in three hospitals as part of a multi-center controlled clinical trial to improve quality of colonoscopy. Previous clinical trials were conducted in one center. The technical challenges for our multicenter clinical trial include 1) reducing additional work by the endoscopists to utilize real-time feedback, 2) handling different colonoscopy practices at different hospitals, and 3) training an effective CNN-based classification model with a large variety of patterns of data in day-to-day colonoscopy practice. We report performance of our real-time systems over a period of 20 weeks at ...

A Two-Stage Design For Comparing Binomial Treatments With A Standard, 2020 University of North Florida

#### A Two-Stage Design For Comparing Binomial Treatments With A Standard, Cecelia K. Schmidt

##### UNF Graduate Theses and Dissertations

We propose a method for comparing success rates of several populations among each other and against a desired standard success rate. This design is appropriate for a situation in which all experimental treatments have only two outcomes that can be considered “success”and “failure” respectively. The goal is to identify which treatment has the highest rate of success that is also higher than the desired standard. The design combines elements of both hypothesis testing and statistical selection. At the first stage, if none of the samples have a number of successes above the appropriate standard for the design, the experiment ...

Three Essays On Health Economics And Policy Evaluation, 2020 West Virginia University

#### Three Essays On Health Economics And Policy Evaluation, Shishir Shakya

##### Graduate Theses, Dissertations, and Problem Reports

This dissertation consists of three essays on the U.S. Health care policy. Each paragraph below refers to the three abstracts for the three chapters in this dissertation, respectively. I provide quantitative evidence on how much Prescription Drug Monitoring Programs (PDMPs) affects the retail opioid prescribing behaviors. Using the American Community Survey (ACS), I retrieve county-level high dimensional panel data set from 2010 to 2017. I employ three separate identification strategies: difference-in-difference, double selection post-LASSO, and spatial difference-in-difference. I compare how the retail opioid prescribing behaviors of counties, that are mandatory for prescribers to check the PDMP before prescribing controlled ...

Comparing Sensitivity To Change Using The 6-Item Versus The 17-Item Hamilton Depression Rating Scale In The Guided Randomized Controlled Trial, 2019 Emory University

#### Comparing Sensitivity To Change Using The 6-Item Versus The 17-Item Hamilton Depression Rating Scale In The Guided Randomized Controlled Trial, Boadie W. Dunlop, Sagar V. Parikh, Anthony J. Rothschild, Michael E. Thase, Charles Debattista, Charles R. Conway, Brent P. Forester, Francis M. Mondimore, Richard C. Shelton, Matthew Macaluso, Jennifer Logan, Paul Traxler, James Li, Holly Johnson, John F. Greden

##### Open Access Articles

BACKGROUND: Previous research suggests that the 17-item Hamilton Depression Rating Scale (HAM-D17) is less sensitive in detecting differences between active treatment and placebo for major depressive disorder (MDD) than is the HAM-D6 scale, which focuses on six core depression symptoms. Whether HAM-D6 shows greater sensitivity when comparing two active MDD treatment arms is unknown.

METHODS: This post hoc analysis used data from the intent-to-treat (ITT) cohort (N = 1541) of the Genomics Used to Improve DEpression Decisions (GUIDED) trial, a rater- and patient-blinded randomized controlled trial. GUIDED compared combinatorial pharmacogenomics-guided care with treatment as usual (TAU) in patients with MDD. Percent ...

Phase Iv Clinical Trials: Postmarketing Surveillance Of Prescription Drugs, 2019 Ohio Northern University

#### Phase Iv Clinical Trials: Postmarketing Surveillance Of Prescription Drugs, Morgan Belling, Jacquline Nunner, Jessica Stemen

##### Pharmacy and Wellness Review

No abstract provided.

Neutral Diagnosis: An Innovative Concept For Medical Device Clinical Trials, 2019 University of Massachusetts Medical School

#### Neutral Diagnosis: An Innovative Concept For Medical Device Clinical Trials, Bo Zhang, Shangyuan Ye, Sravya B. Shankara, Hui Zhang, Qingfeng Zheng

##### Open Access Articles

Study design and statistical analysis are crucial in pivotal clinical trials to evaluate the effectiveness and safety of new medical devices under investigation. In recent years, innovative intraoperative in vivo breast tumor diagnostic devices have been proposed to improve the accuracy and surgical outcomes of breast tumor patients undergoing resection. Although such technologies are promising, investigators need to obtain statistical evidence for the effectiveness and safety of these devices by conducting valid clinical trials. However, the study design and statistical analysis for these clinical trials are complicated. While these trials are designed to provide real-time intraoperative diagnosis of cancerous tissue ...

Effect Of Continuing Olanzapine Vs Placebo On Relapse Among Patients With Psychotic Depression In Remission: The Stop-Pd Ii Randomized Clinical Trial, 2019 University of Toronto

#### Effect Of Continuing Olanzapine Vs Placebo On Relapse Among Patients With Psychotic Depression In Remission: The Stop-Pd Ii Randomized Clinical Trial, Alastair J. Flint, Barnett S. Meyers, Anthony J. Rothschild, Ellen M. Whyte, George S. Alexopoulos, Matthew V. Rudorfer, Patricia Marino, Samprit Banerjee, Cristina D. Pollari, Yiyuan Wu, Aristotle N. Voineskos, Benoit H. Mulsant

##### Psychiatry Publications

Importance: Psychotic depression is a severely disabling and potentially lethal disorder. Little is known about the efficacy and tolerability of continuing antipsychotic medication for patients with psychotic depression in remission.

Objective: To determine the clinical effects of continuing antipsychotic medication once an episode of psychotic depression has responded to combination treatment with an antidepressant and antipsychotic agent.

Design, Setting, and Participants: Thirty-six week randomized clinical trial conducted at 4 academic medical centers. Patients aged 18 years or older had an episode of psychotic depression acutely treated with sertraline plus olanzapine for up to 12 weeks and met criteria for remission ...

Reporting And Analysis Of Repeated Measurements In Preclinical Animals Experiments, 2019 Iowa State University

#### Reporting And Analysis Of Repeated Measurements In Preclinical Animals Experiments, Jing Zhao, Chong Wang, Sarah C. Totton, Jonah N. Cullen, Annette M. O'Connor

##### Veterinary Diagnostic and Production Animal Medicine Publications

A common feature of preclinical animal experiments is repeated measurement of the outcome, e.g., body weight measured in mice pups weekly for 20 weeks. Separate time point analysis or repeated measures analysis approaches can be used to analyze such data. Each approach requires assumptions about the underlying data and violations of these assumptions have implications for estimation of precision, and type I and type II error rates. Given the ethical responsibilities to maximize valid results obtained from animals used in research, our objective was to evaluate approaches to reporting repeated measures design used by investigators and to assess how ...

2019 Southern Methodist University

#### Sample Size Calculation Of Clinical Trials With Correlated Outcomes, Dateng Li

##### Statistical Science Theses and Dissertations

In this thesis, we investigate sample size calculation for three kinds of clinical trials: (1). Randomized controlled trials (RCTs) with longitudinal count outcomes; (2). Cluster randomized trials (CRTs) with count outcomes; (3). CRTs with multiple binary co-primary endpoints.

Unified Methods For Feature Selection In Large-Scale Genomic Studies With Censored Survival Outcomes, 2019 Temple University

#### Unified Methods For Feature Selection In Large-Scale Genomic Studies With Censored Survival Outcomes, Lauren Spirko-Burns, Karthik Devarajan

##### COBRA Preprint Series

One of the major goals in large-scale genomic studies is to identify genes with a prognostic impact on time-to-event outcomes which provide insight into the disease's process. With rapid developments in high-throughput genomic technologies in the past two decades, the scientific community is able to monitor the expression levels of tens of thousands of genes and proteins resulting in enormous data sets where the number of genomic features is far greater than the number of subjects. Methods based on univariate Cox regression are often used to select genomic features related to survival outcome; however, the Cox model assumes proportional ...

A Note On Misspecification In General Linear Models With Correlated Errors For The Analysis Of Crossover Clinical Trials, 2019 University of Mississippi Medical Center

#### A Note On Misspecification In General Linear Models With Correlated Errors For The Analysis Of Crossover Clinical Trials, Wei Wang, Ning Cong, Tian Chen, Hui Zhang, Bo Zhang

##### Open Access Articles

Among various approaches to the repeated measures analysis in crossover clinical trials, the general linear models (GLMs) with correlated errors attract substantial attention due to their simplicity in model specification, implementation, and interpretation. The goal of this research note is to conduct simulation studies to numerically investigate the impact of model misspecification in the GLMs with correlated errors in the analysis of crossover trials. A series of synthetic two-treatment and three-treatment crossover trials were designed, and simulation studies were conducted to assess how treatment effect estimation, type I error rates, and power can be affected by misspecified period effects, carryover ...

2019 Social & Scientific Systems, Inc.

#### Antimicrobial Resistance In Neisseria Gonorrhoeae: Proceedings Of The Star Sexually Transmitted Infection-Clinical Trial Group Programmatic Meeting, Anthony D. Cristillo, Peter A. Rice

##### Open Access Articles

The goal of the Sexually Transmitted Infection Clinical Trial Group's Antimicrobial Resistance (AMR) in Neisseria gonorrhoeae (NG) meeting was to assemble experts from academia, government, nonprofit and industry to discuss the current state of research, gaps and challenges in research and technology and priorities and new directions to address the continued emergence of multidrug-resistant NG infections. Topics discussed at the meeting, which will be the focus of this article, include AMR NG global surveillance initiatives, the use of whole genome sequencing and bioinformatics to understand mutations associated with AMR, mechanisms of AMR, and novel antibiotics, vaccines and other methods ...

Toxoplasma Gondii Igg Associations With Sleepwake Problems, Sleep Duration And Timing, 2019 Air Force Institute of Technology

#### Toxoplasma Gondii Igg Associations With Sleepwake Problems, Sleep Duration And Timing, Celine C. Corona, Ma Zhang, Abhishek Wadhawan, Melanie L. Daue, Maureen W. Groer, Aline Dagang, Christopher A. Lowry, Kathleen A. Ryan, Andrew J. Hoisington, John W. Stiller, Dietmar Fuchs, Braxton D. Mitchell, Teodor T. Postolache

##### Faculty Publications

Background: Evidence links Toxoplasma gondii (T. gondii), a neurotropic parasite, with schizophrenia, mood disorders and suicidal behavior, all of which are associated and exacerbated by disrupted sleep. Moreover, low-grade immune activation and dopaminergic overstimulation, which are consequences of T. gondii infection, could alter sleep patterns and duration. Methods: Sleep data on 833 Amish participants [mean age (SD) = 44.28 (16.99) years; 59.06% women] were obtained via self-reported questionnaires that assessed sleep problems, duration and timing. T. gondii IgG was measured with ELISA. Data were analyzed using multivariable logistic regressions and linear mixed models, with adjustment for age, sex ...