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Articles 31 - 60 of 161

Full-Text Articles in Clinical Trials

Impact Of Simulated Toothbrushing And Dentifrice Abrasiveness On The Surface Roughness, Gloss, And Microhardness Of Cad/Cam Hybrid Restorative Materials, Luana Souza Feb 2024

Impact Of Simulated Toothbrushing And Dentifrice Abrasiveness On The Surface Roughness, Gloss, And Microhardness Of Cad/Cam Hybrid Restorative Materials, Luana Souza

Annual Research Symposium

This study aimed to investigate the impact of toothpaste abrasiveness on the surface roughness, gloss, and microhardness of resin composite and CAD/CAM hybrid materials.


Evaluation Of Oropharyngeal Airway Changes In Skeletal Class11 Patients Undergoing Twin Block Appliance Therapy, K Saidath Feb 2024

Evaluation Of Oropharyngeal Airway Changes In Skeletal Class11 Patients Undergoing Twin Block Appliance Therapy, K Saidath

Annual Research Symposium

The study investigated the changes in oropharyngeal airway dimensions in growing patients with retrognthic mandible and skeletal class 11 paterns, treated with twin block appliance.we evaluated skeletal changes post treatment and their relation to airway alterations


Parental Anxiety Associated With Children Undergoing Dental Treatment-Pulpectomy Procedure Under La, Swathikrishna G Feb 2024

Parental Anxiety Associated With Children Undergoing Dental Treatment-Pulpectomy Procedure Under La, Swathikrishna G

Annual Research Symposium

The aim of this study was to evaluate the anxiety felt by parents of children undergoing dental treatment- pulpectomy procedure under LA.


The Impact Of Palatal Expansion On Airway And Breathing, Sanjeevani Ratti, Akhil Shetty, Pragati Nakra Feb 2024

The Impact Of Palatal Expansion On Airway And Breathing, Sanjeevani Ratti, Akhil Shetty, Pragati Nakra

Annual Research Symposium

Mini-implant assisted rapid palatal expansion (MARPE) is used to correct transverse maxillary deficiencies in orthodontics. While MARPE's influence on occlusal stability and maxillary expansion is recognized, its impact on facial aesthetics, soft tissue morphology, and nasal airway function requires further examination. Our study analyzed the changes in facial soft tissue and airway dimensions in patients undergoing MARPE treatment.


An Emg Study To Evaluate Chewing Efficiency And Maximum Voluntary Clenching (Mvc) For Different Malocclusion Groups Before And During Orthodontic Treatment, Vivek Reddy Feb 2024

An Emg Study To Evaluate Chewing Efficiency And Maximum Voluntary Clenching (Mvc) For Different Malocclusion Groups Before And During Orthodontic Treatment, Vivek Reddy

Annual Research Symposium

The purpose of this study was to investigate the efficacy of chewing and maximum voluntary clenching (MVC) of patients with different malocclusion types by measuring the EMG activity in the masseter and temporalis muscles before and during orthodontic treatment.


Implications And Types Of Artefacts In Oral Histopathology Tissue Processing, Harshitha M, Sowmya S V, Domnic Augustine Feb 2024

Implications And Types Of Artefacts In Oral Histopathology Tissue Processing, Harshitha M, Sowmya S V, Domnic Augustine

Annual Research Symposium

There is a scarcity of information regarding the occurrence and appearance of artefacts in the literature studies observed till date. This study aims to provide a more a comprehensive approach on identifying the different types of artefacts and also attempts to provide with description regarding their relation to the parent slide and the remedies in order to prevent misinterpretation. This study aimed to prepare a comprehensive report of the commonly occurring artefacts in archival collection of pathology laboratory.


To Evaluate The Effect Of Surface Moisture On Dentinal Shear Bond Strength Of Glass Ionomer Restorations In Primary Teeth:An In -Vitro Study, Sherin C Jose Feb 2024

To Evaluate The Effect Of Surface Moisture On Dentinal Shear Bond Strength Of Glass Ionomer Restorations In Primary Teeth:An In -Vitro Study, Sherin C Jose

Annual Research Symposium

Glass ionomer cements that form aninevitable part of pediatric restorative dentistryare inherently sensitive to moisture. The influenceof different drying techniques on the shear bondstrength of glass ionomer cements to primaryteeth dentin has not been established.Thepurpose of the study was to evaluate the effects ofdifferent drying methods for different drying timeperiods on the shear bond strength of GC Fuji IX toprimary tooth dentine.


Perception Of Dental Students Regarding The Role Dentist In Smoking Cessation Counselling, Fathima Huda S, Dr Sudeep C. B Feb 2024

Perception Of Dental Students Regarding The Role Dentist In Smoking Cessation Counselling, Fathima Huda S, Dr Sudeep C. B

Annual Research Symposium

Tobacco use is one of the leading causes of premature death, disease and disability around the world. Six out of eight leading causes of death worldwide are attributed to the diseases related to tobacco use as a risk factor. Healthcare professionals rank high both in effectiveness and preference for providing tobacco cessation counselling. Surveys have found that 58% of smokers made regular appointments with their dentist. Cessation rates of up to 18% have been seen when dental professionals counselled their patients to quit tobacco. The study evaluated dental student’s views about tobacco cessation counselling and their skills as counsellors.


Assessment Of Perceived Stress Levels Among Students In Dental Colleges - A Cross-Sectional Study From South India, Keziah Abraham, Dr.Sudeep C B Feb 2024

Assessment Of Perceived Stress Levels Among Students In Dental Colleges - A Cross-Sectional Study From South India, Keziah Abraham, Dr.Sudeep C B

Annual Research Symposium

According to a report of the Global Congress in Dental Education (2008), “Dental Education is regarded as a complex, demanding and often stressful pedagogical exposure. It involves acquisition of required academic, clinical and interpersonal skills during the course of learning.” Practicing dentistry requires clinical and patient management skills, characteristics that also add to the stress perceived by the students. The aim of this study is to assess the factors affecting stress among students in dental colleges.


Chromatin Pattern Quantification For The Differentiation Of White Blood Cells, Paul Young, Ryan Cordner, Abigail Gordhamer Feb 2024

Chromatin Pattern Quantification For The Differentiation Of White Blood Cells, Paul Young, Ryan Cordner, Abigail Gordhamer

Annual Research Symposium

Nuclear chromatin patterns have been used historically to distinguish between different developmental stages and lineages of white blood cells. While it is common to characterize cells based on arbitrary ‘open’ or ‘closed’ chromatin patterns, quantification of chromatin data is lacking. By extracting nuclei from a database of white blood cells and running fractal analyses using TWOMBLI, we were able to produce meaningful data quantifying chromatin patterns. Our data were put through a random forest algorithm which grouped each point based on relationship probability. The algorithm compared immature and mature cell types as well as cells of similar maturity and differing …


Educational Intervention For Delirium Assessment In Intensive Care Units Using The Confusion Assessment Method, Nathan Nguyen, Kaylee Putney, Alana Whittaker Feb 2024

Educational Intervention For Delirium Assessment In Intensive Care Units Using The Confusion Assessment Method, Nathan Nguyen, Kaylee Putney, Alana Whittaker

Annual Research Symposium

Delirium frequently occurs in severely ill adults, leading to worse outcomes and increased duration of intensive care unit (ICU) and hospital stays, along with higher associated expenses. The 2018 clinical practice guidelines for Pain, Agitation, Delirium, Immobility, and Sleep Disruption (PADIS) recommend that all adult ICU patients be regularly assessed for delirium. At Valley Hospital Medical Center, the utilization of Confusion Assessment Method for the ICU (CAM-ICU) for monitoring delirium is infrequent, typically taking place either after the adjustment of sedatives or in response to nursing reports of positive neurologic assessments indicating signs of delirium.


Ergonomics And Musculoskeletal Disorders Among Dental Students And Practitioners, Ardra Nair S Intern, Sudeep C. B Professor And Head Of The Department Public Health Dentistry Feb 2024

Ergonomics And Musculoskeletal Disorders Among Dental Students And Practitioners, Ardra Nair S Intern, Sudeep C. B Professor And Head Of The Department Public Health Dentistry

Annual Research Symposium

study to determine the prevalence of musculoskeletal disorders among dental students and dental practitioners in Calicut district.


Pharmacognosy And Trichomoniasis: A Scoping Review Protocol, Claire Hartwell, Melanie Arslanian, Brad Haubrich Feb 2024

Pharmacognosy And Trichomoniasis: A Scoping Review Protocol, Claire Hartwell, Melanie Arslanian, Brad Haubrich

Annual Research Symposium

Trichomoniasis, also called “trich”, is the most common non-viral sexually transmitted infection (STI). Its etiological agent is the protozoan parasite Trichomonas vaginalis, against which first-line antiparasitics usually work. However, resistance is on the rise. Trich has traditionally been considered a nuisance infection, with many (particularly AMAB patients) being asymptomatic. But research in recent years has begun to unravel correlations of trichomonal infections with a myriad of comorbitidies, including infertility, cancers, the pathogenesis of AIDS, and pelvic inflammatory disease (PID). Between the rise of drug resistance and the incidence of these comorbidities, new treatments are needed. In this work, we are …


Behind The Spine: Investigating The Role Of Cervical Posture And Range Of Motion On Mental Health, Layla Risdon, Luis Alvarez, Cassidy Byers, Davis Byers, Louis Michelon, Tallon Muhlestein, Natalie Tate, Garret Vincent, Christina Small, David Sant, Kurt Alexander, Kyle Bills Feb 2024

Behind The Spine: Investigating The Role Of Cervical Posture And Range Of Motion On Mental Health, Layla Risdon, Luis Alvarez, Cassidy Byers, Davis Byers, Louis Michelon, Tallon Muhlestein, Natalie Tate, Garret Vincent, Christina Small, David Sant, Kurt Alexander, Kyle Bills

Annual Research Symposium

This research explores the correlation between abnormal forward head posture, cervical range of motion, and psychiatric disorders. Specifically, the study examines the relationships between the loss of cervical lordosis and anxiety, depression, and ADHD. Previous studies have demonstrated the beneficial effect of manipulative therapy on forward head posture and provided a link between postural alignment and cognitive function. This investigation aims to build on existing literature and enhance understanding of how loss of cervical lordosis impacts cervical and overall range of motion as well as its potential association with psychiatric conditions.


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 Feb 2024

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.


Fit Evaluation Of Soft Milled Zirconia And Cocr By Microcomputed Tomography, Elie Daou Feb 2024

Fit Evaluation Of Soft Milled Zirconia And Cocr By Microcomputed Tomography, Elie Daou

Annual Research Symposium

Statement of problem. The absolute marginal fit of CAD-CAM presintered fixed partial dentures has been poorly documented. Purpose. The purpose of this in vitro study was to evaluate the marginal fit of presintered cobalt-chromium (Co-Cr) and zirconia 3-unit fixed partial dentures by using X-ray microcomputed tomography (mCT).

Material and methods. A metal model was prepared from a typodont to receive fixed partial dentures (N=12). The maxillary first premolar and first molar were prepared with a circumferential 1.2-mm chamfer and 2-mm occlusal reduction. The dies were scanned and assigned to 1 of 2 groups to receive the prostheses made of presintered …


Smile Miles Away: Navigating The Future Of Teledentistry, Farhad Jafeen J, Prem Blaisie Rajula, Pl Ravishankar, Shivani Senthilkumar Feb 2024

Smile Miles Away: Navigating The Future Of Teledentistry, Farhad Jafeen J, Prem Blaisie Rajula, Pl Ravishankar, Shivani Senthilkumar

Annual Research Symposium

Teledentistry is a combination of telecommunications and dentistry involving the exchange of clinical information and images over remote distances for dental consultation and treatment planning. Teledentists are capable of improving access to oral healthcare, increasing the provision of oral health care and reducing its costs. The disparities in oral health care between rural and urban areas could also be eliminated. This article analyses the origin, rationale, scope, basis and requirements of teledentistry in conjunction with current evidence available in the literature. Ethical and legal issues relating to teledentistry, as well as the future of this alternative and innovative way of …


Efficacy Of Concentrated Growth Factor Membrane Versus Collagen Membrane In Treating Gingival Recession, Shazneen Kandawalla Feb 2024

Efficacy Of Concentrated Growth Factor Membrane Versus Collagen Membrane In Treating Gingival Recession, Shazneen Kandawalla

Annual Research Symposium

Creating a beautiful smile has always been a cornerstone of dental practice. Gingival recession, characterized by a downward shift of the gum line, causing uneven gum margins and an unattractive appearance.

The Vestibular Incision Subperiosteal Tunnel Access (VISTA) technique, introduced by Zadeh in 2011, offers an innovative solution for root coverage. Concentrated Growth Factor Membrane (CGF) further enhances dental repair.


Spatial Analysis Of Maxillary Central Incisors In Relation To The Nasopalatine Canal And Surrounding Alveolar Bone, Harnoor Dhillon Feb 2024

Spatial Analysis Of Maxillary Central Incisors In Relation To The Nasopalatine Canal And Surrounding Alveolar Bone, Harnoor Dhillon

Annual Research Symposium

The use of mini-implants in orthodontics has enabled greater retraction of incisors than previously achievable. This change underscores the need to understand how incisors relate to the alveolar bone and nasopalatine canal. The varying labiolingual inclination of incisors during orthodontic treatments may influence these anatomical relationships. Our study aimed to assess the spatial relationship between maxillary central incisors and the surrounding alveolar bone and nasopalatine canal.


Implementation Of Best Practice When Collecting Blood Cultures In The Emergency Department (Ed), Parker Grossman Feb 2024

Implementation Of Best Practice When Collecting Blood Cultures In The Emergency Department (Ed), Parker Grossman

Annual Research Symposium

The purpose of this study is to compare blood culture contamination rates in the ED before and after educational in-services on best practice.


Detection And Relative Quantitation Of Changes In Gene Expression Of Hippo Proteins In Doxorubicin-Exposed Human Cells By Rt-Qpcr, Lillian Fleisher, Tricia Domingo, Christopher So, Stephen Lee Feb 2024

Detection And Relative Quantitation Of Changes In Gene Expression Of Hippo Proteins In Doxorubicin-Exposed Human Cells By Rt-Qpcr, Lillian Fleisher, Tricia Domingo, Christopher So, Stephen Lee

Annual Research Symposium

The HIPPO signaling pathway plays a key role in cell proliferation and tumor suppression. It consists of serine/threonine kinase cascades, including MST1/2, LATS1/2, YAP, and TAZ. When the HIPPO pathway is activated, gene expression is altered. Dysfunction of the activity of this cascade may contribute to cancer development and chemoresistance. FAT4 is an intracellular protein that may regulate the HIPPO signaling. The purpose of this study is to determine the relative changes of mRNA of the HIPPO pathway members and FAT4 in doxorubicin-treated and vehicle-treated in vitro cell lines.


Outpatient Fall Prevention In Ambulatory Adults 65 Years Old And Over, Dorothy L. Osborne-White Jan 2024

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 …


Cabozantinib Plus Atezolizumab In Previously Untreated Advanced Hepatocellular Carcinoma And Previously Treated Gastric Cancer And Gastroesophageal Junction Adenocarcinoma: Results From Two Expansion Cohorts Of A Multicentre, Open-Label, Phase 1b Trial (Cosmic-021)., Daneng Li, Yohann Loriot, Adam Burgoyne, James Cleary, Armando Santoro, Daniel Lin, Santiago Ponce Aix, Ignacio Garrido-Laguna, Ramu Sudhagoni, Xiang Guo, Svetlana Andrianova, Scott Paulson Dec 2023

Cabozantinib Plus Atezolizumab In Previously Untreated Advanced Hepatocellular Carcinoma And Previously Treated Gastric Cancer And Gastroesophageal Junction Adenocarcinoma: Results From Two Expansion Cohorts Of A Multicentre, Open-Label, Phase 1b Trial (Cosmic-021)., Daneng Li, Yohann Loriot, Adam Burgoyne, James Cleary, Armando Santoro, Daniel Lin, Santiago Ponce Aix, Ignacio Garrido-Laguna, Ramu Sudhagoni, Xiang Guo, Svetlana Andrianova, Scott Paulson

Kimmel Cancer Center Faculty Papers

BACKGROUND: Cabozantinib is approved for previously treated advanced hepatocellular carcinoma (aHCC) and has been investigated in gastric cancer (GC) and gastroesophageal junction adenocarcinoma (GEJ). Atezolizumab plus bevacizumab is approved for unresectable or metastatic HCC untreated with prior systemic therapy. We evaluated efficacy and safety of cabozantinib plus atezolizumab in aHCC previously untreated with systemic anticancer therapy or previously treated GC/GEJ.

METHODS: COSMIC-021 (ClinicalTrials.gov, NCT03170960) is an open-label, phase 1b study in solid tumours with a dose-escalation stage followed by tumour-specific expansion cohorts, including aHCC (cohort 14) and GC/GEJ (cohort 15). Eligible patients were aged ≥18 years with measurable locally advanced, …


Prt543, A Protein Arginine Methyltransferase 5 Inhibitor, In Patients With Advanced Adenoid Cystic Carcinoma: An Open-Label, Phase I Dose-Expansion Study, Renata Ferrarotto, Paul Swiecicki, Dan Zandberg, Robert Baiocchi, Robert Wesolowski, Cristina Rodriguez, Meredith Mckean, Hyunseok Kang, Varun Monga, Rajneesh Nath, Neil Palmisiano, Naveen Babbar, William Sun, Glenn Hanna Dec 2023

Prt543, A Protein Arginine Methyltransferase 5 Inhibitor, In Patients With Advanced Adenoid Cystic Carcinoma: An Open-Label, Phase I Dose-Expansion Study, Renata Ferrarotto, Paul Swiecicki, Dan Zandberg, Robert Baiocchi, Robert Wesolowski, Cristina Rodriguez, Meredith Mckean, Hyunseok Kang, Varun Monga, Rajneesh Nath, Neil Palmisiano, Naveen Babbar, William Sun, Glenn Hanna

Department of Medical Oncology Faculty Papers

OBJECTIVES: Currently, no systemic treatments are approved for patients with recurrent and/or metastatic (R/M) adenoid cystic carcinoma (ACC). PRT543, a protein arginine methyltransferase 5 inhibitor that downregulates NOTCH1 and MYB signalling in tumours, is a potential candidate for R/M ACC treatment. We report the safety, tolerability and preliminary efficacy of PRT543 in a dose-expansion cohort of patients with R/M ACC.

MATERIALS AND METHODS: This phase I multicentre, open-label, sequential-cohort, dose-escalation and dose-expansion study (NCT03886831) enrolled patients with advanced solid tumours and select haematologic malignancies. Dose-escalation study design and results were reported previously. In the dose expansion, patients with R/M ACC …


Stereotactic Mr-Guided On-Table Adaptive Radiation Therapy (Smart) For Borderline Resectable And Locally Advanced Pancreatic Cancer: A Multi-Center, Open-Label Phase 2 Study, Michael Chuong, Percy Lee, Daniel Low, Joshua Kim, Kathryn Mittauer, Michael Bassetti, Carri Glide-Hurst, Ann Raldow, Yingli Yang, Lorraine Portelance, Kyle Padgett, Bassem Zaki, Rongxiao Zhang, Hyun Kim, Lauren Henke, Alex Price, Joseph Mancias, Christopher Williams, John Ng, Ryan Pennell, M Raphael Pfeffer, Daphne Levin, Adam Mueller, Karen Mooney, Patrick Kelly, Amish Shah, Luca Boldrini, Lorenzo Placidi, Martin Fuss, Parag Jitendra Parikh Dec 2023

Stereotactic Mr-Guided On-Table Adaptive Radiation Therapy (Smart) For Borderline Resectable And Locally Advanced Pancreatic Cancer: A Multi-Center, Open-Label Phase 2 Study, Michael Chuong, Percy Lee, Daniel Low, Joshua Kim, Kathryn Mittauer, Michael Bassetti, Carri Glide-Hurst, Ann Raldow, Yingli Yang, Lorraine Portelance, Kyle Padgett, Bassem Zaki, Rongxiao Zhang, Hyun Kim, Lauren Henke, Alex Price, Joseph Mancias, Christopher Williams, John Ng, Ryan Pennell, M Raphael Pfeffer, Daphne Levin, Adam Mueller, Karen Mooney, Patrick Kelly, Amish Shah, Luca Boldrini, Lorenzo Placidi, Martin Fuss, Parag Jitendra Parikh

Department of Radiation Oncology Faculty Papers

BACKGROUND AND PURPOSE: Radiation dose escalation may improve local control (LC) and overall survival (OS) in select pancreatic ductal adenocarcinoma (PDAC) patients. We prospectively evaluated the safety and efficacy of ablative stereotactic magnetic resonance (MR)-guided adaptive radiation therapy (SMART) for borderline resectable (BRPC) and locally advanced pancreas cancer (LAPC). The primary endpoint of acute grade ≥ 3 gastrointestinal (GI) toxicity definitely related to SMART was previously published with median follow-up (FU) 8.8 months from SMART. We now present more mature outcomes including OS and late toxicity.

MATERIALS AND METHODS: This prospective, multi-center, single-arm open-label phase 2 trial (NCT03621644) enrolled 136 …


Test Event Example 12/14/23, Metzalli Demolastname Dec 2023

Test Event Example 12/14/23, Metzalli Demolastname

Annual Research Symposium

No abstract provided.


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 Dec 2023

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 …


Repurposing The Fda-Approved Anthelmintic Pyrvinium Pamoate For Pancreatic Cancer Treatment: Study Protocol For A Phase I Clinical Trial In Early-Stage Pancreatic Ductal Adenocarcinoma, Francesca M. Ponzini, Christopher W. Schultz, Benjamin E. Leiby, Shawnna Cannaday, T. Yeo, James Posey, Wilbur B. Bowne, Charles Yeo, Jonathan R. Brody, Harish Lavu, Avinoam Nevler Oct 2023

Repurposing The Fda-Approved Anthelmintic Pyrvinium Pamoate For Pancreatic Cancer Treatment: Study Protocol For A Phase I Clinical Trial In Early-Stage Pancreatic Ductal Adenocarcinoma, Francesca M. Ponzini, Christopher W. Schultz, Benjamin E. Leiby, Shawnna Cannaday, T. Yeo, James Posey, Wilbur B. Bowne, Charles Yeo, Jonathan R. Brody, Harish Lavu, Avinoam Nevler

Department of Surgery Faculty Papers

BACKGROUND: Recent reports of the utilisation of pyrvinium pamoate (PP), an FDA-approved anti-helminth, have shown that it inhibits pancreatic ductal adenocarcinoma (PDAC) cell growth and proliferation in-vitro and in-vivo in preclinical models. Here, we report about an ongoing phase I open-label, single-arm, dose escalation clinical trial to determine the safety and tolerability of PP in PDAC surgical candidates.

METHODS AND ANALYSIS: In a 3+3 dose design, PP is initiated 3 days prior to surgery. The first three patients will be treated with the initial dose of PP at 5 mg/kg orally for 3 days prior to surgery. Dose doubling will …


Sickle Cell Disease Treatment With Arginine Therapy (Start): Study Protocol For A Phase 3 Randomized Controlled Trial., Chris A Rees, David C. Brousseau, Daniel M Cohen, Anthony Villella, Carlton Dampier, Kathleen Brown, Andrew Campbell, Corrie E Chumpitazi, Gladstone Airewele, Todd Chang, Christopher Denton, Angela Ellison, Alexis Thompson, Fahd Ahmad, Nitya Bakshi, Keli D Coleman, Sara Leibovich, Deborah Leake, Dunia Hatabah, Hagar Wilkinson, Michelle Robinson, T Charles Casper, Elliott Vichinsky, Claudia R Morris Aug 2023

Sickle Cell Disease Treatment With Arginine Therapy (Start): Study Protocol For A Phase 3 Randomized Controlled Trial., Chris A Rees, David C. Brousseau, Daniel M Cohen, Anthony Villella, Carlton Dampier, Kathleen Brown, Andrew Campbell, Corrie E Chumpitazi, Gladstone Airewele, Todd Chang, Christopher Denton, Angela Ellison, Alexis Thompson, Fahd Ahmad, Nitya Bakshi, Keli D Coleman, Sara Leibovich, Deborah Leake, Dunia Hatabah, Hagar Wilkinson, Michelle Robinson, T Charles Casper, Elliott Vichinsky, Claudia R Morris

Department of Pediatrics Faculty Papers

BACKGROUND: Despite substantial illness burden and healthcare utilization conferred by pain from vaso-occlusive episodes (VOE) in children with sickle cell disease (SCD), disease-modifying therapies to effectively treat SCD-VOE are lacking. The aim of the Sickle Cell Disease Treatment with Arginine Therapy (STArT) Trial is to provide definitive evidence regarding the efficacy of intravenous arginine as a treatment for acute SCD-VOE among children, adolescents, and young adults.

METHODS: STArT is a double-blind, placebo-controlled, randomized, phase 3, multicenter trial of intravenous arginine therapy in 360 children, adolescents, and young adults who present with SCD-VOE. The STArT Trial is being conducted at 10 …


Bayesian Semi-Mechanistic Dose-Finding Designs For Phase I Oncology Trials, Chao Yang May 2023

Bayesian Semi-Mechanistic Dose-Finding Designs For Phase I Oncology Trials, Chao Yang

Dissertations and Theses (Open Access)

Bayesian adaptive designs are getting more popular in research and in practice because they are flexible and efficient in evaluating an experimental drug. In oncology, despite the great advances in novel dose-finding designs, the high failure rates of clinical cancer drug development from phase I to III trials call for further improvements on novel designs, in addition to the need to promote and adopt novel designs in practice. Because anticancer agents often have a narrow therapeutic index, an accurate identification of the maximum tolerated dose (MTD) in a phase I trial is crucial for identifying a tolerable and efficacious dose …