Clinical Trials Commons^™

C37: Evaluation Of The Diagnostic Efficacy Of Saliva For Detection Of Dengue Antibodies- An Elisa Study, Vidya Gurram Shankar

Annual Research Symposium

No abstract provided.

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.

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.

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 …

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.

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.

Resident Heart Rate Variability During Cataract Surgery, Ahmad Baiyasi, Shibandri Das, Ferris Bayasi, Faisal Ridha Al-Timimi

Medical Student Research Symposium

Purpose: To evaluate ophthalmology resident anxiousness and cardiovascular response by tracking resident heart rate (HR) when performing cataract surgery during their last year of residency.

Methods: A prospective analysis of 31 cataract cases, completed by three residents (two females and one male), at the Kresge Eye Institute in August and September 2020 was performed. Inclusion criteria for cases included all cataract cases performed by PGY-4 residents at the Kresge Eye Institute who downloaded the Heart Graph app supported by iOS. Residents with android mobile devices were excluded from the study. Informed consent was obtained from all residents who utilized the …

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 Research

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 for …

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 Research

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 were calculated …

Novel Inference Methods For Generalized Linear Models Using Shrinkage Priors And Data Augmentation., Arinjita Bhattacharyya

Electronic Theses and Dissertations

Generalized linear models have broad applications in biostatistics and sociology. In a regression setup, the main target is to find a relevant set of predictors out of a large collection of covariates. Sparsity is the assumption that only a few of these covariates in a regression setup have a meaningful correlation with an outcome variate of interest. Sparsity is incorporated by regularizing the irrelevant slopes towards zero without changing the relevant predictors and keeping the resulting inferences intact. Frequentist variable selection and sparsity are addressed by popular techniques like Lasso, Elastic Net. Bayesian penalized regression can tackle the curse of …

A Modular Framework For Early-Phase Seamless Oncology Trials, Philip S. Boonstra, Thomas M. Braun, Elizabeth C. Chase

The University of Michigan Department of Biostatistics Working Paper Series

Background: As our understanding of the etiology and mechanisms of cancer becomes more sophisticated and the number of therapeutic options increases, phase I oncology trials today have multiple primary objectives. Many such designs are now 'seamless', meaning that the trial estimates both the maximum tolerated dose and the efficacy at this dose level. Sponsors often proceed with further study only with this additional efficacy evidence. However, with this increasing complexity in trial design, it becomes challenging to articulate fundamental operating characteristics of these trials, such as (i) what is the probability that the design will identify an acceptable, i.e. safe …

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 and family …

A Parent-Led Intervention To Promote Recovery Following Pediatric Injury: Study Protocol For A Randomized Controlled Trial, Meghan L. Marsac, Ginny Sprang, Leila Guller, Kristen L. Kohser, John M. Draus Jr., Nancy Kassam-Adams

Pediatrics Faculty Publications

Background: Injury is one of the most prevalent potentially emotionally traumatic events that children experience and can lead to persistent impaired physical and emotional health. There is a need for interventions that promote full physical and emotional recovery and that can be easily accessed by all injured children. Based on research evidence regarding post-injury recovery, we created the Cellie Coping Kit for Children with Injury intervention to target key mechanisms of action and refined the intervention based on feedback from children, families, and experts in the field. The Cellie Coping Kit intervention is parent-guided and includes a toy (for engagement), …

Quality Of Life During Treatment With Chemohormonal Therapy: Analysis Of E3805 Chemohormonal Androgen Ablation Randomized Trial In Prostate Cancer, Alicia K. Morgans, Yu-Hui Chen, Christopher J. Sweeney, David F. Jarrard, Elizabeth R. Plimack, Benjamin A. Gartrell, Michael A. Carducci, Maha Hussain, Jorge A. Garcia, David Cella, Robert S. Dipaola, Linda J. Patrick-Miller

Internal Medicine Faculty Publications

Purpose

Chemohormonal therapy with docetaxel and androgen deprivation therapy (ADT+D) for metastatic hormone-sensitive prostate cancer improves overall survival as compared with androgen deprivation therapy (ADT) alone. We compared the quality of life (QOL) between patients with metastatic hormone-sensitive prostate cancer who were treated with ADT+D and those who were treated with ADT alone.

Methods

Men were randomly assigned to ADT+ D (six cycles) or to ADT alone. QOL was assessed by Functional Assessment of Cancer Therapy-Prostate (FACT-P), FACT-Taxane, Functional Assessment of Chronic Illness Therapy-Fatigue, and the Brief Pain Inventory at baseline and at 3, 6, 9, and 12 months. The …

Telotristat Ethyl In Carcinoid Syndrome: Safety And Efficacy In The Telecast Phase 3 Trial, Marianne Pavel, David J. Gross, Marta Benavent, Petros Perros, Raj Srirajaskanthan, Richard R. P. Warner, Matthew H. Kulke, Lowell B. Anthony, Pamela L. Kunz, Dieter Hörsch, Martin O Weickert, Pablo Lapuerta, Wenjun Jiang, Kenneth Kassler-Taub, Suman Wason, Rosanna Fleming, Douglas Fleming, Rocio Garcia-Carbonero

Internal Medicine Faculty Publications

Telotristat ethyl, a tryptophan hydroxylase inhibitor, was efficacious and well tolerated in the phase 3 TELESTAR study in patients with carcinoid syndrome (CS) experiencing ≥ 4 bowel movements per day (BMs/day) while on somatostatin analogs (SSAs). TELECAST, a phase 3 companion study, assessed the safety and efficacy of telotristat ethyl in patients with CS (diarrhea, flushing, abdominal pain, nausea or elevated urinary 5-hydroxyindoleacetic acid (u5-HIAA)) with < 4 BMs/day on SSAs (or ≥ 1 symptom or ≥ 4 BMs/day if not on SSAs) during a 12-week double-blind treatment period followed by a 36-week open-label extension (OLE). The primary safety and efficacy endpoints were incidence of treatment-emergent adverse events (TEAEs) and percent change from baseline in 24-h u5-HIAA at week 12. Patients (N = 76) were randomly assigned (1:1:1) to receive placebo or telotristat ethyl 250 mg or 500 mg 3 times per day (tid); 67 continued receiving telotristat ethyl 500 mg tid during the OLE. …

A Checklist For Clinical Trials In Rare Disease: Obstacles And Anticipatory Actions-Lessons Learned From The For-Dmd Trial, R Crow, K Hart, M Mcdermott, R Tawil, W Martens, Mathula Thangarajh, +Several Additional Authors

Neurology Faculty Publications

Background: Trials in rare diseases have many challenges, among which are the need to set up multiple sites in different countries to achieve recruitment targets and the divergent landscape of clinical trial regulations in those countries. Over the past years, there have been initiatives to facilitate the process of international study set-up, but the fruits of these deliberations require time to be operationally in place. FOR-DMD (Finding the Optimum Steroid Regimen for Duchenne Muscular Dystrophy) is an academic-led clinical trial which aims to find the optimum steroid regimen for Duchenne muscular dystrophy, funded by the National Institutes of Health (NIH) …

Long-Term Follow-Up Of Cardiac Function And Quality Of Life For Patients In Nsabp Protocol B-31/Nrg Oncology: A Randomized Trial Comparing The Safety And Efficacy Of Doxorubicin And Cyclophosphamide (Ac) Followed By Paclitaxel With Ac Followed By Paclitaxel And Trastuzumab In Patients With Node-Positive Breast Cancer With Tumors Overexpressing Human Epidermal Growth Factor Receptor 2, Patricia A. Ganz, Edward H. Romond, Reena S. Cecchini, Priya Rastogi, Charles E. Geyer Jr., Sandra M. Swain, Jong-Hyeon Jeong, Louis Fehrenbacher, Howard M. Gross, Adam M. Brufsky, Patrick J. Flynn, Tanya A. Wahl, Thomas E. Seay, James L. Wade Iii, David D. Biggs, James N. Atkins, Jonathan Polikoff, John L. Zapas, Eleftherios P. Mamounas, Norman Wolmark

Markey Cancer Center Faculty Publications

Purpose

Early cardiac toxicity is a risk associated with adjuvant chemotherapy plus trastuzumab. However, objective measures of cardiac function and health-related quality of life are lacking in long-term follow-up of patients who remain cancer free after completion of adjuvant treatment.

Patients and Methods

Patients in NSABP Protocol B-31 received anthracycline and taxane chemotherapy with or without trastuzumab for adjuvant treatment of node-positive, human epidermal growth factor receptor 2–positive early-stage breast cancer. A long-term follow-up assessment was undertaken for patients who were alive and disease free, which included measurement of left ventricular ejection fraction by multigated acquisition scan along with patient-reported …

Reducing Symptom Distress In Patients With Advanced Cancer Using An E-Alert System For Caregivers: Pooled Analysis Of Two Randomized Clinical Trials, David H. Gustafson, Lori L. Dubenske, Amy K. Atwood, Ming-Yuan Chih, Roberta A. Johnson, Fiona Mctavish, Andrew Quanbeck, Roger L. Brown, James F. Cleary, Dhavan Shah

Health and Clinical Sciences Faculty Publications

Background: Symptom distress in patients toward the end of life can change rapidly. Family caregivers have the potential to help patients manage those symptoms, as well as their own stress, if they are equipped with the proper resources. Electronic health (eHealth) systems may be able to provide those resources. Very sick patients may not be able to use such systems themselves to report their symptoms but family caregivers could.

Objective: The aim of this paper was to assess the effects on cancer patient symptom distress of an eHealth system that alerts clinicians to significant changes in the patient’s symptoms, as …

First-In-Human Clinical Trial Of Oral Onc201 In Patients With Refractory Solid Tumors, Mark N. Stein, Joseph R. Bertino, Howard L. Kaufman, Tina M. Mayer, Rebecca A. Moss, Ann W. Silk, Nancy Chan, Jyoti Malhotra, Loma Rodriguez, Joseph Aisner, Robert Aiken, Bruce G. Haffty, Robert S. Dipaola, Tracie Saunders, Andrew Zloza, Sherri Damare, Yasmeen Beckett, Bangning Yu, Saltanat Najmi, Christian Gabel, Sioghan Dickerson, Ling Zheng, Wafik S. El-Deiry, Joshua E. Allen, Martin Stogniew, Wolfgang Oster, Janice M. Mehnert

Internal Medicine Faculty Publications

Purpose: ONC201 is a small-molecule selective antagonist of the G protein–coupled receptor DRD2 that is the founding member of the imipridone class of compounds. A first-in-human phase I study of ONC201 was conducted to determine its recommended phase II dose (RP2D).

Experimental Design: This open-label study treated 10 patients during dose escalation with histologically confirmed advanced solid tumors. Patients received ONC201 orally once every 3 weeks, defined as one cycle, at doses from 125 to 625 mg using an accelerated titration design. An additional 18 patients were treated at the RP2D in an expansion phase to collect additional safety, …

Treatment Pathway Of Bone Sarcoma In Children, Adolescents, And Young Adults, Damon R. Reed, Masanori Hayashi, Lars M. Wagner, Odion Binitie, Diana A. Steppan, Andrew S. Brohl, Eric T. Shinohara, Julia A. Bridge, David M. Loeb, Scott C. Borinstein, Michael S. Isakoff

Pediatrics Faculty Publications

When pediatric, adolescent, and young adult patients present with a bone sarcoma, treatment decisions, especially after relapse, are complex and require a multidisciplinary approach. This review presents scenarios commonly encountered in the therapy of bone sarcomas with the goal of objectively presenting a consensus, multidisciplinary management approach. Little variation was found in the authors' group with respect to local control or systemic therapy. Clinical trials were universally prioritized in all settings. Decisions regarding relapse therapies in the absence of a clinical trial had very minor variations initially, but a consensus was reached after a literature review and discussion. This review …