Clinical Trials Commons^™

Feasibility And Acceptability Of Automated Texts To Offer, Screen, And Enroll Patients In A Cancer Clinical Trial Financial Reimbursement Program: Mixed Methods Study, Ashley E Santaniello, Hena Patel, Sarah Milinski, Mohan Balachandran, Vivian Nguyen, E. Paul Wileyto, Robert H. Vonderheide, Dana Dornsife, Robert G. Johnson, Carmen E. Guerra

Student Papers, Posters & Projects

BACKGROUND: Out-of-pocket (OOP) costs pose a significant barrier to participating in cancer clinical trials (CCTs). Financial reimbursement programs (FRPs) that reduce the burden of OOP costs can support participation in CCTs if the information is readily available to participants at the time of enrollment. Prior studies have shown the importance and impact of FRPs, but despite improvements, significant barriers still remain.

OBJECTIVE: This study was designed to explore the feasibility and acceptability of automated texts designed to offer, screen, and enroll CCT participants in an FRP for OOP travel and lodging-related clinical trial costs.

METHODS: This study used a mixed …

A Phase 1, First-In-Human, Dose Escalation Study Of Jnj-80038114, A Psmaxcd3 Bispecific Antibody, In Participants With Metastatic Castration-Resistant Prostate Cancer, Andrew Hudson, Anuradha Jayaram, Benjamin Garmezy, Nicholas Zorko, Kevin Zarrabi, Ligi Mathews, Brent Rupnow, Mengjie Li, Debopriya Ghosh, Karen Urtishak, Peter Francis, Sherry Wang, Edward Attiyeh, Johann De Bono

Department of Medical Oncology Faculty Papers

PURPOSE: Prostate-specific membrane antigen (PSMA) has been identified as a therapeutic target for metastatic castration-resistant prostate cancer (mCRPC). The recent success of radioligands targeting PSMA spurred development of new PSMA-targeting agents including immunotherapy. JNJ-80038114 is a bispecific antibody that binds PSMA on tumor cells and CD3 on T cells to induce anti-tumor activity.

METHODS: This was a phase 1, open-label, multicenter study of JNJ-80038114 in participants with mCRPC and ≥ 1 prior systemic therapy. JNJ-80038114 was administered subcutaneously every 3 weeks (Q3W), starting at 0.1 mg. The primary endpoint was safety. Secondary endpoints included pharmacokinetics (PK), immunogenicity, and prostate-specific antigen …

Reply To: S. N. Katkuri Et Al. And H. Liu Et Al. On Early And Sustained Improvements In Sense Of Smell With Tezepelumab Treatment In Patients With Chronic Rhinosinusitis With Nasal Polyps (Waypoint), Joaquim Mullol, Joseph K. Han, Tanya M. Laidlaw, Claire Hopkins, Anju T. Peters, Oliver Pfaar, Martin Desrosiers, Stella E. Lee, Andrew P. Lane, Claudia Chen, Yun Chon, Sandhia S. Ponnarambil, Andrew Foster, Andrew W. Lindsley, Christopher S. Ambrose

Department of Otolaryngology (ENT) Faculty Publications

[Introduction] We thank Dr. S. N. Katkuri, Dr. H. Liu, and their coauthors [1, 2] for their interest in our recent publication describing the improvements in loss of smell symptoms with tezepelumab versus placebo in patients with uncontrolled chronic rhinosinusitis with nasal polyps (CRSwNP) in the WAYPOINT trial (NCT04851964) [3]. We are grateful for the authors' feedback on the clinical significance of the data presented and their appreciation of the consistency observed across a range of baseline clinical characteristic and demographic subgroups.

Emerging Clinical Role Of Tavapadon, A Novel Dopamine Partial Agonist, In The Treatment Of Parkinson’S Disease, Alan D. Kaye, Bennett M. Ford, Brennan M. Abbott, Kalob M. Broocks, Sofia Novacic, Sahar Shekoohi

School of Medicine Faculty Publications

Tavapadon, a novel oral dopamine-D1R/D5R partial agonist, has been studied in recent years for the treatment of late-stage development Parkinson’s disease (PD). Levodopa, a dopamine precursor that currently remains the gold-standard first-line therapy for PD motor symptoms, serves as a benchmark against emerging dopaminergic agents. By selectively activating D1-family receptors on direct-pathway medium neurons, Tavapadon differs in that it delivers levodopa-level motor benefit while avoiding its many D2R/D3R-mediated adverse effects. In placebo-controlled trials, Tavapadon produced clear, clinically meaningful gains in motor function and day-to-day activities, as captured by the Unified Parkinson’s Disease Rating Scale (UPDRS). Recent late-stage results have revealed …

Strengthening The Paediatric Clinical Trial Ecosystem To Better Inform Policy And Programmes, James A. Berkley, Judd L. Walson, Glenda Gray, Fiona Russell, Zulfiqar Ahmed Bhutta, Per Ashorn, Shane A. Norris, Ebunoluwa A. Adejuyigbe, Rebecca Grais, Bernhards Ogutu

Institute for Global Health and Development

The first WHO Global Clinical Trials Forum was convened in November, 2023 to develop a shared vision of an effective global clinical trial infrastructure. The Paediatric Clinical Trials Working Group was formed to provide perspectives, identify challenges, and propose solutions to strengthen the paediatric clinical trials ecosystem. Participants represented paediatric disciplines, including infectious diseases, nutrition, neonatology, pharmacology, oncology, neurodevelopment, public health, and policy. Childhood diseases have profound lifelong effects on health, livelihoods, and societies. Investment in early childhood results in highly cost-effective changes to lifelong health, productivity, and human capital returns. Yet, there remain substantial gaps in knowledge on the …

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 …

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 …

Accessible Real-Time Eye-Gaze Tracking For Neurocognitive Health Assessments, A Multimodal Web-Based Approach, Daniel C. Tisdale

Master's Theses

We introduce a novel integration of real-time, predictive eye-gaze tracking models into a multimodal dialogue system tailored for remote health assessments. This system is designed to be highly accessible requiring only a conventional webcam for video input along with minimal cursor interaction and utilizes engaging gaze-based tasks that can be performed directly in a web browser. We have crafted dynamic subsystems that capture high-quality data efficiently and maintain quality through instances of user attrition and incomplete calls. Additionally, these subsystems are designed with the foresight to allow for future re-analysis using improved predictive models, as well as enable the creation …

A Systematic Review: Mirror Neurons & Schizophrenia, Yashesvi Sharma, Surajit Dey

Annual Research Symposium

This research project establishes a link between Mirror Neuron System (MNS) activity and this information's implications in treating and understanding schizophrenia, specifically, schizophrenic patients with negative symptoms.

Revolutionizing Denture Excellence: An Invigorating In-Vitro Exploration Of Organic Products In Prosthetic Rehabilitation, Nighila Ravindran, Sneha Joseph, Aswani Surya K

Annual Research Symposium

The denture base comes into contact with diverse substances in the oral cavity, acting as a reservoir for microorganisms like corynebacterium, streptococcus, lactobacillus, and candida. This colonization elevates the risk of complications such as denture stomatitis and candidiasis. Commercial denture cleaners have explored the use of natural ingredients, less commonly employed but offering various advantages. These ingredients aim to mitigate the potential issues associated with microbial colonization on denture surfaces, contributing to improved oral hygiene for denture wearers. The exploration of natural elements reflects a nuanced approach to denture care, considering both efficacy and less conventional alternatives.

Investigating Racial And Ethnic Healthcare Disparities In Screenable Ob/Gyn-Related Cancers, Lara Laughrey

Annual Research Symposium

This is a scoping review of peer-reviewed literature addressing healthcare inequity based on race and ethnicity with a specific focus on Ob/Gyn-related management and treatment of screenable cancers.

Assessment Of Emotional Intelligence Among Students In Dental College, Gowri Nandana S Final Year Student, Sudeep C. B Professor And Head Of The Department Of Public Health Dentistry

Annual Research Symposium

Over an extended period, the examination of intelligence predominantly centered on the adaptive deployment of cognitive abilities. In more recent times, scholars such as Gardner (1983) and Sternberg (1988) have proposed comprehensive frameworks for comprehending intelligence. Pioneering the concept of "emotional intelligence," Salovey and Mayer (1990) posited that emotional intelligence encompasses three distinct categories of adaptive capabilities: the evaluation and expression of emotions, the regulation of emotions, and the utilization of emotions in problem-solving. The objective is to evaluate emotional intelligence among dental students across various educational institutions.

Quality Of Life In Orthodontics, Claudia Eisenhuth, Gabriel Eisenhuth, Connor Schwartz, Amir Mohajeri, Man Hung, Tiffany Nelson, Ryann Glenn

Annual Research Symposium

Orthodontic treatment goes beyond mere cosmetic enhancement; it significantly impacts various aspects of an individual's quality of life. Beyond the physical benefits of improved oral function and prevention of dental issues, orthodontics also yields profound psychological benefits. Aligned teeth enhance self-confidence, reduce social anxiety, and contribute to better relationships and professional opportunities. Moreover, addressing dental concerns through orthodontic treatment reduces psychological distress and promotes overall happiness and satisfaction. Real-life case studies vividly illustrate the transformative effects of orthodontic interventions, emphasizing the importance of considering quality of life outcomes in dental care.

Exploring The Interconnected Role Of The Oral Microbiome And Periodontal Disease In The Development And Progression Of Oral Squamous Cell Carcinoma, Malak Al-Regib, Claudia M. Tellez Freitas

Annual Research Symposium

This comprehensive review explores the complex linkage among the oral microbiome, periodontal disease, and the onset and progression of oral squamous cell carcinoma (OSCC).

Success And Challenges Of Infrazygomatic Crest Implants In Orthodontics, Gauri Gill

Annual Research Symposium

Poster on success rates of mini implants used in the infrazygomatic region for orthodontic anchorage , as well as the factors that influence the success of the mini implant placed in IZC region.

Investigating The Role Of Chaos In Minimizing Tumor Growth, Maxwell Geiger

Annual Research Symposium

Chaos is a type of motion found in mathematical systems that is highly sensitive to initial conditions. While many biological systems described in literature have been analyzed for the presence of chaotic dynamics, there are still many that are yet to be discovered. The goal of this project is to reassess Itik and Banks’ discovery of chaotic behavior in their population dynamics model of cancer growth. Once chaotic behavior is confirmed, we want to investigate how chaos could possibly be controlled to minimize tumor growth and discover novel treatments for cancer patients.

A Pharmacist’S Central Role In Improving Hormonal Contraceptive Access, Aleese Smith, Urvi Patel, Alexandra Arledge, Josie Young, Erin Johanson

Annual Research Symposium

In 2019, the roles of Utah pharmacists grew with the implementation of a statewide standing order allowing prescribing abilities for hormonal contraceptives. With the rates of unplanned pregnancies in Utah up to 1 in every 5; pharmacists have a new role in birth control distribution. Pharmacists and pharmacy interns across the state of Utah are able to prescribe self-administered hormonal contraceptive medications including: oral pills, vaginal insertion medications, and birth control patches. Pharmacists are entrusted with the responsibility to evaluate the patient and their needs to ensure all women receiving birth control are educated about the risks and side effects …

The National Status Of Pharmacists’ Ability To Prescribe Hormonal Contraceptives, Aleese Smith, Urvi Patel, Alexandra Arledge, Josie Young, Erin Johanson

Annual Research Symposium

The scope of practice for pharmacists first expanded in California and Oregon with the ability to prescribe hormonal contraceptives to patients in their communities. Since 2016, over 33 states now allow for pharmacist prescribing of birth control in their pharmacy practice laws.

90% of Americans live within 5 miles of a retail pharmacy, making community pharmacies an accessible resource who may otherwise be unable to access contraceptives. The gap in care experienced by certain patient populations is now being filled by pharmacists with their ability to prescribe birth control.

Ligaplant: Recreating Natural From Artificial, Disha Kamavisdar

Annual Research Symposium

Missing teeth can be substituted by the use of the dental implants. The most widely used implants in the current scenario are the osseointegrated implants with various shortcomings and the most prominent one is the lack of the periodontal ligament. To overcome this, implants with periodontal ligaments can be procured and this can be possible by the application of the tissue engineering concept along with suitable implant material.

Application Of In-Silico Computational Biology Strategies To Demonstrate Mechanism Of Oral Cancer Cell Death By Natural Peptide, Dr Dominic Augustine

Annual Research Symposium

This research work is designed to identify biomolecules from Earthworm Coelomic Fluid (ECF) of Eudrilus Eugeniae (EE) that can inhibit oral cancer cells from proliferating. The study aims to construct a homology model of the 18 kDa protein from ECF of EE (18-ECFP) with molecular dynamics simulation (MDS) to enable its molecular docking with pro-apoptotic caspase receptors with determination of binding energy scores. The study also evaluates the anti-cancer potential of 18-ECFP on SCC-9 cells in vitro by wet lab techniques.

Pathogenic Implications Of Candidal Species In Both Oral Cancer And Oral Potentially Malignant Disorders - A Review, Dr Dominic Augustine, Sowmya Sv, Kuntala Mondal

Annual Research Symposium

Oral squamous cell carcinoma (OSCC) is the 6th most common cancer in worldwide. Cigarette smoking, alcohol consumption, and betel quid chewing are its major risk factors other factors that can lead to OSCC include excessive sun exposure, viral or fungal infection, poor nutrition, and poor oral hygiene. The carcinogenesis of OSCC occurs gradually and oral epithelial dysplasia is considered a potential histologic precursor of OSCC. Most OSCC cases are preceded by clinically evident oral potentially malignant disorders (OPMDs). The aim of this review is to correlate the association between Candida species and oral potentially malignant disorders and its possible mechanisms …

Immunohistochemical Expression Of Cyclin D1 In Dentigerous Cyst, Odontogenic Keratocyst And Unicystic Ameloblastoma- An In-Vitro Study, Kuntala Mondal, Sv Sowmya, Dominic Augustine

Annual Research Symposium

Cyclin D1, a G1 cyclin member, regulates the transition of the cell cycle from the G1 phase to the S phase. The uncontrolled and elevated expression of cyclin D1 has been associated with rapid growth, heightened proliferative activity and increased histologic aggressiveness. Unicystic ameloblastoma pertains to cystic lesions that present clinical, radiographic, or gross features akin to jaw cysts. Nevertheless, upon histological scrutiny, these lesions display a distinctive ameloblastomatous epithelium lining the cystic cavity, with or without luminal or mural proliferation. This cystic variant of tumor bears substantial resemblances to dentigerous cysts, and occasionally, both entities can become indistinguishable upon …

An Immunohistochemical Panel For The Accurate Differentiation Between Mucoepidermoid Carcinoma And Pleomorphic Adenoma, Kuntala Mondal, Sv Sowmya, Dominic Augustine

Annual Research Symposium

Salivary Gland Tumors (SGTs) are a diverse group of neoplasms, with a wide range of histological subtypes, some of which can exhibit overlapping features. Amongst this group of tumors, Pleomorphic Adenoma (PA) and Mucoepidermoid Carcinoma (MEC) stand out as prevalent entities originating from the salivary glands. The accurate differentiation between these two entities is crucial for treatment planning, as it influences decisions regarding the extent of surgical resection. Because of the overlapping histopathological features, it is difficult to differentiate these two lesions with the help of conventional Hematoxylin & Eosin (H& E). The evaluation of Immunohistochemical (IHC) markers holds pivotal …

Cheiloscopic Characteristics Detection And Pattern Classification By Machine Learning Technique, Dr Dominic Augustine, Sowmya Sv

Annual Research Symposium

Machine Learning (ML) is a field enhancing the rapid growth of technology. Though use of digital softwares for cheiloscopic investigations have been attempted with limited success, the use of ML based techniques are scarce and seldom have been employed in forensic odontology. The present study aimed to identify cheiloscopic patterns through machine learning based methods and to correlate the segmented patterns with age and gender of individuals.

Association Between Abo Blood Grouping And Odontometry: An Unexplored Evidence In Forensics, Dr Dominic Augustine, Sowmya Sv

Annual Research Symposium

Recent research has exhibited a strong association between ABO blood groups and susceptibility to diseases. Extraoral and intraoral hard tissue landmarks provide a stable and reliable record for odontological and anthropological analysis, forensic investigations and identification. The association between anthropometric indices and ABO blood grouping have been reported in the past, however, the association between ABO blood groups and odontometric indices is yet to be comprehensively explored. This study aimed to establish the correlation of ABO blood groups with odontometric indices and extraoral hard tissue landmarks for personnel identification.

Advanced Techniques For Tooth Pulp Rna Extraction In Forensic Investigations-A Systematic Review, Kuntala Mondal, Sv Sowmya, Dominic Augustine

Annual Research Symposium

Teeth are fundamental structures in a forensic context due to their high strength and specificity. It is challenging to obtain high quality RNA from pulpal tissues. It has been described that pulp RNA degradation could be an indicator of post-mortem interval. Researchers have been in the quest to develop optimal techniques for tooth RNA extraction. The systematic review aimed to determine the most reliable method of RNA extraction from dental tooth pulp for forensic investigations.

Assessment Of Micrometastasis In Lymph Nodes Of Oral Squamous Cell Carcinoma –Attaining Excellence Through Immunohistochemistry, Dr Dominic Augustine, Sowmya Sv, Kuntala Mondal

Annual Research Symposium

Cervical lymph node metastasis is the most important prognostic factor in Squamous Cell Carcinoma of Head and Neck (SCCHN). Lymph node prognostic determinants hold immense significance in influencing both patient’s survival outcomes and the propensity for recurrence. The current study aimed to evaluate the diagnostic accuracy of Cyclin D1 and Pan-CK for the detection of lymph node micrometastasis in oral squamous cell carcinoma tissue sections and re-evaluate the tumor staging.

Harm Reduction Measures In Substance Use Disorder (Sud), Kent Wood

Annual Research Symposium

This literature review aims to comprehensively analyze harm reduction strategies employed in addressing Substance Use Disorder (SUD). Focusing on key interventions such as fentanyl testing strips, naloxone distribution, syringe exchange programs, and methadone/buprenorphine clinics, the study seeks to evaluate the effectiveness of these approaches in reducing the associated harms of substance misuse.

Substance Use Disorder –The Role Of The Pharmacist, Mackenzie Cruzan

Annual Research Symposium

The study illuminates the pivotal role of community pharmacists as accessible healthcare providers, offering medication management, patient education, and preventive care services. Simultaneously, it explores the intricate responsibilities of inpatient pharmacists, emphasizing their involvement in therapeutic monitoring and collaboration with healthcare teams.

Clinical, Radiographic And Biochemical Evaluation Of One-Piece Vs Two-Piece Single Implants After 5 Years Of Functional Loading, Ippolito Caputo

Annual Research Symposium

The aim of this study was to compare the clinical and radiographic conditions and the expression of proinflammatory cytokines in peri-implant crevicular fluid (PICF) of two-piece/bone level (TP/BL) versus one-piece/tissue level (OP/TL) single implants with a laser-microgrooved collar after at least 5 years of functional loading.