Clinical Trials Commons^™

C36: Clinical Evaluation Of Bupivacaine Liposomal, Samaya Cristina (Shuput)

Annual Research Symposium

No abstract provided.

C33: Covid Encephalitis Resulting In Focal Seizures With Subsequent Changes On Mri Imaging, Adena Shahinian

Annual Research Symposium

No abstract provided.

C30: A Comparison Of Cbct Soft Tissue With Bellus3d Facial Scan Superimposition, Gerald Sherrick

Annual Research Symposium

Research Symposium

C29: Epilepsy Partialis Continua With Transient Post-Ictal Changes On Mri, Trusha Mehta Do

Annual Research Symposium

No abstract provided.

C28: Acute Encephalopathy As A Presenting Sign Of Suspected Lupus Cerebritis, Jasmine Chopra

Annual Research Symposium

No abstract provided.

C22: Eravacycline Versus Best Previously Available Therapy In Adults With Pneumonia Due To Drug-Resistant Acinetobacter Baumannii, Courtney Jane Scott, Rebecca Jayakumar, Elizabeth Zhu, Velliyur Viswesh

Annual Research Symposium

There are no published studies documenting outcomes with the use of eravacycline against drug-resistant Acinetobacter baumannii. The purpose of this study is to assess the efficacy of eravacycline use, in comparison to best previously available therapy, in patients with drug-resistant Acinetobacter baumannii pneumonia.

C20: A Comparison Of Heparin Vs Bivalirudin In Patients Undergoing Percutaneous Coronary Intervention (Pci) In Achieving Therapeutic Activated Clotting Time, Priyanga Radjassegarane, Ragini Bhakta, Joanne Dominguez

Annual Research Symposium

No abstract provided.

C17: Programmed Cell Death Ligand- 1 Expression As A Prognostic Indicator In Oral Squamous Cell Carcinoma, Dr. Samar Saeed Khan

Annual Research Symposium

No abstract provided.

C16: On-The-Spot Transport Media For The Freshly Biopsied Soft Tissue Specimen: A Comparative Study, Snehashish Ghosh

Annual Research Symposium

No abstract provided.

C10: Oral Potentially Malignant Disorders Prevalence In The Orthodontic Clinic, Mark Greene

Annual Research Symposium

No abstract provided.

C8: Intravenous (Iv) Bolus Versus Iv Infusion As Initial Approach For Blood Pressure (Bp) In Acute Ischemic Stroke (Ais) Patients Receiving Tissue-Plasminogen Activator (Tpa), Alexander D. Bonca, Alana Whittaker

Annual Research Symposium

No abstract provided.

C4: Comparing The Sub-Gingival Levels Of Cytomegalovirus, Epstein-Barr Virus, Porphyromonas Gingivalis In Human Immunodeficiency Virus-1 Seropositive Patients With And Without Antiretroviral Therapy, Supriya Kheur

Annual Research Symposium

No abstract provided.

S3: Post-Covid-19 Recovery Care Plan For Older Adults With Continuing Symptoms Of Breathlessness And Fatigue, Nancy M. Bryan, Marie Wright-Rolf Edd, Msn, Rn, Siboney Zelaya Ph.D., Mph, Msn Ed, Rn, Justin Carbonel

Annual Research Symposium

Background:

The CDC research actively continues gathering information related to short and long-term symptoms that remain following the acute phase of Covid-19 diagnosis (CDC, 2020).

Fatigue and shortness of breath are listed among the most commonly reported long-term symptoms of Covid-19:

1. Fatigue
2. Shortness of Breath
3. Cough
4. Joint Pain
5. Chest Pain (CDC, 2020).

Evidence suggests that older adults over the age of 60 who have multiple comorbidities are more susceptible and are at a higher risk of contracting the Covid-19 virus thus potentially prolonging recovery time post diagnosis (Greenhalgh, Knight, A’Court, Buxton, & Husain, 2020).

The Agency for Healthcare Research and …

P5: Covid-19 Vaccine: Technology Platform, Efficacy And Immune Protection, Manas Mandal

Annual Research Symposium

Roseman Research Day Symposium.

P2: Characteristics Of Individuals With Oral Hpv Positive Results, Val Cheever, Eric Hon, Andrew J. Gross, Man Hung

Annual Research Symposium

No abstract provided.

O2: In-Silico Approach To Analyze Anticancer Activity Of Withania Somnifera In Oral Cancer, Gauri Kumbhar

Annual Research Symposium

No abstract provided.

Three Essays On Health Economics And Policy Evaluation, Shishir Shakya

Graduate Theses, Dissertations, and Problem Reports (ETD)

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 substances …

Safety Constraint Optimization Of Combination Drug Therapy In Hypertension Clinical Trials, Victor Chukwu

College of Graduate Studies: Theses & Dissertations

In Clinical Practice, combination drug therapy has become common in treating many disease conditions. The purpose of these combinations is often to ensure optimal efficacy and to reduce adverse effects that may arise from monotherapy. Clinical trials have also been conducted to ensure efficacy and safety of these combinations before they are introduced into the market. However, adverse effects still occur with combination therapies. The objective of this study is to (1) To determine a region of optimum doses of Drug A and Drug B in combination while focusing on efficacy alone (2) To determine a region of optimum doses …

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 …

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, …

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.

When Is A Randomised Controlled Trial Health Equity Relevant? Development And Validation Of A Conceptual Framework, J. Jull, M. Whitehead, M. Petticrew, E. Kristjansson, D. Gough, Sarah Baird, +Several Additional Authors

Global Health Faculty Publications

Background Randomised controlled trials can provide evidence relevant to assessing the equity impact of an intervention, but such information is often poorly reported. We describe a conceptual framework to identify health equity-relevant randomised trials with the aim of improving the design and reporting of such trials.

Methods An interdisciplinary and international research team engaged in an iterative consensus building process to develop and refine the conceptual framework via face-to-face meetings, teleconferences and email correspondence, including findings from a validation exercise whereby two independent reviewers used the emerging framework to classify a sample of randomised trials.

Results A randomised trial can …

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 …

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 …

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

Dartmouth Scholarship

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.

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

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 Antihypertensive Responses …

The Unseen And Untold Issues Of Clinical Trials And Research Ethics In Pakistan., Shahan Waheed, Emaduddin Siddiqui

Department of Emergency Medicine

No abstract provided.

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

CHIP Documents

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 …

Improving Statistical Analysis Of Prospective Clinical Trials In Stem Cell Transplantation. An Inventory Of New Approaches In Survival Analysis, Aurelien Latouche

COBRA Preprint Series

The CLINT project is an European Union funded project, run as a specific support action, under the sixth framework programme. It is a 2 year project aimed at supporting the European Group for Blood and Marrow Transplantation (EBMT) to develop its infrastructure for the conduct of trans-European clinical trials in accordance with the EU Clinical Trials Directive, and to facilitate International prospective clinical trials in stem cell transplantation. The initial task is to create an inventory of the existing biostatistical literature on new approaches to survival analyses that are not currently widely utilised. The estimation of survival endpoints is introduced, …

Nonparametric Regression With Missing Outcomes Using Weighted Kernel Estimating Equations, Lu Wang, Andrea Rotnitzky, Xihong Lin

Harvard University Biostatistics Working Paper Series

No abstract provided.