Clinical Trials Commons^™

Evaluating Alpha Spending Functions Applied To Observational Time-To-Event Analysis, Moses Torgbenu

Electronic Theses and Dissertations

This thesis explores the theoretical foundation of the alpha spending approach and extends its application beyond the conventional setting of randomized controlled trials (RCTs) to observational studies with time to event analyses. In these less structured environments, key design parameters such as the total number of events are often unknown, posing challenges for the standard implementation of sequential analysis methods.

Through simulation studies, this research delivers several important contributions. First, it presents a modified approach that uses calendar time to define the timing of interim analyses while relying on event-based information to estimate the correlation among test statistics. This adjustment …

Lactoferrin And Lysozyme To Promote Nutritional, Clinical And Enteric Recovery: A Protocol For A Factorial, Blinded, Placebo-Controlled Randomised Trial Among Children With Diarrhoea And Malnutrition (The Boresha Afya Trial), Ruchi Tiwari, Kirkby Tickell, Emily Yoshioka, Joyce Otieno, Adeel Shah, Barbra Richardson, Lucia Keter, Maureen Okello, Churchil Nyabinda, Indi Trehan

Paediatrics and Child Health, East Africa

Introduction: Children with moderate or severe wasting are at particularly high risk of recurrent or persistent diarrhoea, nutritional deterioration and death following a diarrhoeal episode. Lactoferrin and lysozyme are nutritional supplements that may reduce the risk of recurrent diarrhoeal episodes and accelerate nutritional recovery by treating or preventing underlying enteric infections and/or improving enteric function.

Methods and analysis: In this factorial, blinded, placebo-controlled randomised trial, we aim to determine the efficacy of lactoferrin and lysozyme supplementation in decreasing diarrhoea incidence and improving nutritional recovery in Kenyan children convalescing from comorbid diarrhoea and wasting. Six hundred children aged 6–24 months with …

High Fat Diet & Social Isolation: Interactive Effects On Pain, Cognition, & Neuroinflammation, Ian M. Campuzano

Research Psychology Theses

Prior research has established a role for both social isolation and exposure to high fat Western diets in altering a range of behaviors from reduced memory performance to increased depression-like behaviors. The present study scrutinizes the interplay among these variables during the peri-adolescent developmental phase, utilizing Long-Evans rats as the experimental model. Our overarching hypothesis is that rats exposed to either social isolation, a high-fat diet, or both will result in heightened pain sensitivity, diminished cognitive flexibility, and increased neuroinflammatory responses within brain regions implicated in sociability, cognition, memory, and pain processing. Behavioral flexibility will be assessed using a maze-based …

Ocular Gene Transfer In The Spotlight: Implications Of Newspaper Content For Clinical Communications, Shelly Benjaminy, Tania M. Bubela

Office of the Provost

Background: Ocular gene transfer clinical trials are raising hopes for blindness treatments and attracting media attention. News media provide an accessible health information source for patients and the public, but are often criticized for overemphasizing benefits and underplaying risks of novel biomedical interventions. Overly optimistic portrayals of unproven interventions may influence public and patient expectations; the latter may cause patients to downplay risks and over-emphasize benefits, with implications for informed consent for clinical trials. We analyze the news media communications landscape about ocular gene transfer and make recommendations for improving communications between clinicians and potential trial participants in light of …

Long Non-Coding Rna As A Potential Diagnostic Tool In Coronary Artery Diseases - A Systematic Review, Arthi Sri A.S, Vishnu Priya Veeraraghavan

Annual Research Symposium

POSTER - SYSTEMATIC REVIEW - LONG NON CODING RNAS AS DIAGNOSTIC MARKER FOR CAD

Correlation Between Salivary Levels And Tissue Expression Status Of Her2 In Breast Cancer Patients - A Cross-Sectional Study, Arthi Sri A.S, Massillamani F, Vinothkumar Thilla Sekar

Annual Research Symposium

The study aims to investigate if soluble salivary human epidermal growth factor receptor-2 (HER2) would play a role in the diagnosis of breast cancer patients and also to find out the influence of demographic and hormonal factors on the salivary HER2 levels in breast cancer.

Outpatient Fall Prevention In Ambulatory Adults 65 Years Old And Over, Dorothy L. Osborne-White

Doctor of Nursing Practice (DNP) Scholarly Projects - Archive

Background: In the United States (U.S.), falls are the leading cause of injury among adults 65 and over, resulting in 36 million falls yearly (Moreland et al., 2020). According to the Centers for Disease Control and Prevention (CDC, 2023), one in four older adults experiences a fall each year. Falls are the world's second most prominent cause of accidental deaths (World Health Organization [WHO], 2021). Falls are the leading cause of both fatal and non-fatal injuries among older adults (Moreland et al., 2020).

Methods: A quality improvement project that included a fall bundle was implemented in a primary clinic. A …

The Dose-Response Effect Of Aerobic Exercise On Inflammation In Colon Cancer Survivors, Justin C. Brown, Stephanie L.E. Compton, Jeffrey A. Meyerhardt, Guillaume Spielmann, Shengping Yang

School of Medicine Faculty Publications

Background; Physical activity after surgical resection for colon cancer is associated with significantly longer disease-free survival. Inflammation is hypothesized to mediate the association between physical activity and disease-free survival in colon cancer. Methods; In this exploratory analysis of a randomized dose-response trial, 39 colon cancer survivors who completed standard therapy were stratified by cancer stage and randomized in a 1;1;1 ratio to one of three treatment groups for 24 weeks of usual-care control, 150 min/wk of moderate-intensity aerobic exercise (low-dose), or 300 min/wk of moderate-intensity aerobic exercise (high-dose). Inflammation outcomes included high-sensitivity C-reactive protein (hs-CRP), interleukin-6 (IL6), and soluble tumor …

The Importance Of Contrast Sensitivity, Color Vision, And Electrophysiological Testing In Clinical And Occupational Settings, Frances Silva

Theses & Dissertations

Visual acuity (VA) is universally accepted as the gold standard metric for ocular vision and function. Contrast sensitivity (CS), color vision, and electrophysiological testing for clinical and occupational settings are warranted despite being deemed ancillary and minimally utilized by clinicians. These assessments provide essential information to subjectively and objectively quantify and obtain optimal functional vision. They are useful for baseline data and monitoring hereditary and progressive ocular conditions and cognitive function. The studies in this dissertation highlight the value of contrast sensitivity, color vision, and cone specific electrophysiological testing, as well as the novel metrics obtained with potential practical clinical …

Predicting Hiv Vaccine-Mediated Protection Level To Identify Immune Correlates Using Positive Unlabeled Learning, Shiwei Xu

Dartmouth College Ph.D Dissertations

The development of a vaccine for Human Immunodeficiency Virus type 1 (HIV-1) is a crucial step in preventing the global spread of AIDS. To ensure the progress and effectiveness of this vaccine, it is essential to establish efficient biotechnology platforms and data mining methods. These methods would help identify immune characteristics that distinguish individuals with varying levels of vaccine-induced protection and determine the underlying factors that contribute to protection against HIV acquisition. While previous studies have focused on identifying immune markers associated with infection outcomes among vaccinated patients, it is important to acknowledge the limitations of traditional case-control analytical protocols …

Intellectual Disability Related To De Novo Germline Loss Of The Distal End Of The P-Arm Of Chromosome 17: A Case Report, Eden Pope, Matthew Huertas, Amar Paul, Braden Cunningham, Matthew Jennings, Ryan Perry, Stephanie Chavez, John A. Kriak, Kyle B. Bills, David W. Sant

Annual Research Symposium

Hypothesis/Purpose: In this report we present a case of a 20-year-old female with congenital intellectual disability, stunted growth, and hypothyroidism. Competitive genetic hybridization (CHG) revealed a loss of 17p13.3, and the deletion was not present in either parent. This deletion has not previously been characterized, but mutations on the p-arm of chromosome 17 are responsible for Miller-Dieker Syndrome and Isolated Lissencephaly Sequence, both of which share symptoms in common with the patient.

Methods: Peripheral mononuclear cells (PBMCs) were used for karyotyping and competitive genetic hybridization (CHG). Bioinformatic analysis was carried out using the Genome Data Viewer (ncbi.nlm.nih.gov/genome/gdv).

Results: Karyotype was …

Investigating Respiratory Simplification Caused By Prenatal Rage Upregulation, Paul Reynolds

Annual Research Symposium

No abstract provided.

Potential Role For Rage In The Development Of Secondhand Smoke-Induced Chronic Sinusitis, Paul Reynolds

Annual Research Symposium

No abstract provided.

Rage Inhibition Reduces Timp And Decreases Cell Invasion In Cigarette Smoke Extract (Cse) Treated Oral Squamous Carcinoma Cells, Paul Reynolds

Annual Research Symposium

No abstract provided.

Inflammatory Cytokine Elaboration Following Secondhand Smoke Exposure Is Mediated In Part By Rage Signaling, Paul Reynolds

Annual Research Symposium

No abstract provided.

Rage Availability Lessens The Degree Of Dysfunctional Mitochondrial Bioenergetics Following Chronic Secondhand Smoke Exposure, Paul Reynolds

Annual Research Symposium

No abstract provided.

Gestational Dependent Responses To Second Hand Smoke (Shs) In Mouse Pregnancies, Paul Reynolds

Annual Research Symposium

No abstract provided.

Reversible Emerging Neuropsychological Pattern In Chronic Intractable Migraine, Tanner Williford, Pooja Chemiti, Mason Allen, Brandon Burrell, Stephanie Chavez, Jude Emego, Bridger Gunter, Matthew Huertas, Matthew Jennings, Roshni Jogin, Paulo Kelly, Laura Minor, Steven Salazar, Jameson Williams, David W. Sant, John A. Kriak, Kyle B. Bills

Annual Research Symposium

No abstract provided.

Appearance Of Two Distinct Clusters Of Glucose Dysregulation In Chronic Intractable Migraine, Roshni Jogin, Kaitlyn Mcfarland, Aparna Naik, Tanner Williford, Matthew Conway, Amar Paul, John A. Kriak, David W. Sant, Kyle B. Bills

Annual Research Symposium

No abstract provided.

Heterodyned Whole-Body Vibration Ameliorates Anxiety In Opioid-Use Disorder, Kailee Edwards, Braden Cunningham, Alfred Amendolara, Marryam Anwar, Jon Gonzales, Roshni Jogin, Wyatt Magoffin, Amar Paul, Ryan Perry, James Pike, Nathan Swallow, Steven Tung, Mary Seamons, Andrew Payne, John A. Kriak, David W. Sant, David W. Sant

Annual Research Symposium

No abstract provided.

Presentation Of Paired P- And Q-Arm Mosaic Deletions On Chromosome 18 Associated With Neuropsychiatric Symptoms, Jackson Nielsen, Laura Minor, John Dougherty Jr., Paige Moore, Kailee Edwards, Brandon Burrell, Jameson Williams, John A. Kriak, David W. Sant, Kyle B. Bills

Annual Research Symposium

No abstract provided.

Eeg-Based Spanish Language Proficiency Classification: An Eeg Power Spectrum And Cross-Spectrum Analysis, Blaise Xavier O'Mara, Skyler Baumer

Honors Theses and Capstones

Second language proficiency may be predicted with electrophysiological techniques. In a machine learning application, this electrophysiological data may be used for language instructors and language students to assess their language learning. This study identifies how electroencephalogram (EEG) power spectrum and cross spectrum data of the brain cortex relates to Spanish second language (L2) proficiency of 20 Spanish language students of varying proficiency levels at the University of New Hampshire. The two metrics for assessing cortical power and processing were event-related desynchronization (ERD)—a measure of relative change in power—of the alpha (8-12 Hz) brain frequency band, and alpha and beta (13-30Hz) …

Machine Learning Methods For Prediction Of Human Infectious Virus And Imputation Of Hla Alleles, Xiaoqing Gao

Dissertations, Master's Theses and Master's Reports

This dissertation contains three Chapters. The following is a concise description of each Chapters.

In Chapter 1, we introduced the Random Forest, a machine learning method, to foresee whether a virus is capable of infecting humans. The Covid pandemic informs us the importance of predicting the ability of a zoonotic virus that can infect humans from its genomic sequence. We used the -mer with and as features of a virus to predict if it can affect humans. We further employed the Boruta algorithm to select the important features, then fed those important features into the Random Forest method to train …

The Effects Of Metronomic And Maximum-Tolerated Dose Chemotherapy In Colorectal Cancer Angiogenesis: A Combined Approach Using Endoscopic Diffuse Reflectance Spectroscopy And Mrna Expression, Ariel Isaac Mundo Ortiz

Graduate Theses and Dissertations

Colorectal cancer (CRC) continues to be one of the most incident and deadliest types of cancer worldwide. Chemotherapy has proven effective to reduce tumor burden for CRC patients, but there are several disadvantages associated with the use of mainstay maximtolerated dose (MTD) chemotherapeutic strategies. Metronomic chemotherapy (MET) has been developed as an alternative that addresses the shortcomings of maximum-tolerated dose chemotherapy but so far its effectiveness as a neoadjuvant strategy for CRC has not been explored.

This dissertation uses a combined optics and molecular biology approach (using diffuse reflectance spectroscopy and mRNA expression) to study the changes in angiogenesis and …

Rna Sequencing Reveals That Cyp3a5 Sirna Treatment Induces Cell Cycle Blockade And Senescence In Mdapca2b Human Prostate Cancer Cells, Jeetesh Sharma

Annual Research Symposium

No abstract provided.

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 …

Systematic Review Of Polyherbal Combinations Used In Metabolic Syndrome, Amber Hanif Palla, Faridah Amin, Bilqees Fatima, Arooj Shafiq, Najeeb Ur Rehman, Ikram Ul Haq, Anwar-Ul-Hassan Gilani

Department of Biological & Biomedical Sciences

Background: Metabolic syndrome (MetS) is a multifactorial disease, whose main stay of prevention and management is life-style modification which is difficult to attain. Combination of herbs have proven more efficacious in multi-targeted diseases, as compared to individual herbs owing to the "effect enhancing and side-effect neutralizing" properties of herbs, which forms the basis of polyherbal therapies This led us to review literature on the efficacy of herbal combinations in MetS.
Methods: Electronic search of literature was conducted by using Cinnahl, Pubmed central, Cochrane and Web of Science, whereas, Google scholar was used as secondary search tool. The key words used …

B14: Angiogenic Potential Of Oral Cavity Derived Mesenchymal Stem Cells And Its Secretomes: A Systematic Review, Madhura Rajendra Shekatkar

Annual Research Symposium

No abstract provided.

P14: Emerging Role Of Pharmacists In Treatment And Vaccination For Covid-19, Dwaynie Bacon Jr, Man Ha, Dr. Mandal

Annual Research Symposium

No abstract provided.

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 hazards …