Medicine and Health Sciences Commons^™

A Novel, Brief, Fully Automated Intervention To Extend The Antidepressant Effect Of A Single Ketamine Infusion: A Randomized Clinical Trial, Rebecca B Price, Crystal Spotts, Benjamin Panny, Angela Griffo, Michelle Degutis, Nicolas Cruz, Elizabeth Bell, Kevin Do-Nguyen, Meredith L Wallace, Sanjay J Mathew, Robert H Howland

Staff and Researcher Publications

Objective: Intravenous ketamine, which displays rapid antidepressant properties, is posited to reverse depression by rapidly enhancing neuroplasticity. The authors tested whether an automated, computer-based approach could efficiently leverage enhanced neuroplasticity to extend the durability of rapid clinical response.

Methods: A total of 154 adults (ages 18-60) with treatment-resistant unipolar depression were randomized in a double-blind, parallel-arm design to receive an active/active treatment combination (ketamine plus active "automated self-association training" [ASAT]; N=53) or one of two control arms that lacked either the active drug component (saline plus active ASAT; N=51) or the active behavioral component (ketamine plus sham ASAT; N=50). One …

International Pooled Patient-Level Meta-Analysis Of Ketamine Infusion For Depression: In Search Of Clinical Moderators, Rebecca B Price, Nicholas Kissel, Andrew Baumeister, Rebecca Rohac, Mary L Woody, Elizabeth D Ballard, Carlos A Zarate, William Deakin, Chadi G Abdallah, Adriana Feder, Dennis S Charney, Michael F Grunebaum, J John Mann, Sanjay J Mathew, Bronagh Gallagher, Declan M Mcloughlin, James W Murrough, Suresh Muthukumaraswamy, Rebecca Mcmillan, Rachael Sumner, George Papakostas, Maurizio Fava, Rebecca Hock, Jennifer L Phillips, Pierre Blier, Paulo Shiroma, Peter Šóš, Tung-Ping Su, Mu-Hong Chen, Mikael Tiger, Johan Lundberg, Samuel T Wilkinson, Meredith L Wallace

Children’s Nutrition Research Center Staff Publications

Depression is disabling and highly prevalent. Intravenous (IV) ketamine displays rapid-onset antidepressant properties, but little is known regarding which patients are most likely to benefit, limiting personalized prescriptions. We identified randomized controlled trials of IV ketamine that recruited individuals with a relevant psychiatric diagnosis (e.g., unipolar or bipolar depression; post-traumatic stress disorder), included one or more control arms, did not provide any other study-administered treatment in conjunction with ketamine (although clinically prescribed concurrent treatments were allowable), and assessed outcome using either the Montgomery-Åsberg Depression Rating Scale or the Hamilton Rating Scale for Depression (HRSD-17). Individual patient-level data for at least …

Design Of The Remedē System Therapy (Rēst) Study: A Prospective Non-Randomized Post-Market Study Collecting Clinical Data On Safety And Effectiveness Of The Remedē System For The Treatment Of Central Sleep Apnea, Lee R Goldberg, Henrik Fox, Christoph Stellbrink, Biykem Bozkurt, John P Boehmer, Jorge I Mora, Rahul Doshi, Timothy I Morgenthaler, Wayne C Levy, Timothy E Meyer, Scott W Mckane, Robin Germany, Remedē System Therapy Study Group

Faculty, Staff and Students Publications

Background: Central sleep apnea (CSA) is a disorder defined by lack of respiratory drive from the brain stem on breathing efforts. There is a lack of established therapies for CSA and most available therapies are limited by poor patient adherence, limited randomized controlled studies, and potentially adverse cardiovascular effects. The remedē System (ZOLL Respicardia, Inc., Minnetonka, Minnesota) uses transvenous phrenic nerve stimulation to stimulate the diaphragm, thereby restoring a more normal breathing pattern throughout the sleep period.

Methods: The remedē System Therapy (rēST) Study is a prospective non-randomized multicenter international study evaluating long-term safety and effectiveness of the remedē System …

Evaluation Of Mrna-1273 Vaccine In Children 6 Months To 5 Years Of Age, Evan J Anderson, C Buddy Creech, Vladimir Berthaud, Arin Piramzadian, Kimball A Johnson, Marcus Zervos, Fredric Garner, Carl Griffin, Khozema Palanpurwala, Mark Turner, Jeffrey Gerber, Richard L Bennett, Kashif Ali, Madhavi Ampajwala, Gary Berman, Jennifer Nayak, Carey Chronis, Barbara Rizzardi, William J Muller, Christopher A Smith, George Fuchs, Daniel Hsia, Joanne E Tomassini, Dianne Delucia, Caroline Reuter, Barbara Kuter, Xiaoping Zhao, Weiping Deng, Honghong Zhou, Daniela Ramirez Schrempp, Kelly Hautzinger, Bethany Girard, Karen Slobod, Roderick Mcphee, Rolando Pajon, Anne Aunins, Rituparna Das, Jacqueline M Miller, Sabine Schnyder Ghamloush, Kidcove Study Group

Faculty, Staff and Student Publications

BACKGROUND: The safety, reactogenicity, immunogenicity, and efficacy of the mRNA-1273 coronavirus disease 2019 (Covid-19) vaccine in young children are unknown.

METHODS: Part 1 of this ongoing phase 2-3 trial was open label for dose selection; part 2 was an observer-blinded, placebo-controlled evaluation of the selected dose. In part 2, we randomly assigned young children (6 months to 5 years of age) in a 3:1 ratio to receive two 25-μg injections of mRNA-1273 or placebo, administered 28 days apart. The primary objectives were to evaluate the safety and reactogenicity of the vaccine and to determine whether the immune response in these …

Trends, Predictors, And Outcomes Of Transcatheter Aortic Valve Implantation In Patients With Bicuspid Aortic Valve Related Disease: Insights From The Nationwide Inpatient Sample And Nationwide Readmission Database, Waqas Ullah, Salman Zahid, Hamza Muhammadzai, Fouad Khalil, Arnav Kumar, Abdul Mannan Khan Minhas, Muhammad Zia Khan, Salim S Virani, David L Fischman, Pinak Shah, Deepak L Bhatt

Faculty, Staff and Students Publications

Background: Transcatheter aortic valve implantation (TAVI) has increasingly been utilized in patients with bicuspid aortic valve (BAV) related aortic stenosis (AS) with insufficient large-scale data on its safety.

Methods: The Nationwide Inpatient Sample and Nationwide Readmission Database (2011-2018) were queried to identify patients undergoing TAVI for BAV versus trileaflet aortic valve (TAV) associated AS. The in-hospital, 30- and 180-day odds of outcomes were assessed using a propensity-matched analysis (PSM) to calculate adjusted odds ratios (aOR) with its 95% confidence interval (CI).

Results: A total of 216,723 TAVI (TAV: 214,050 and BAV: 2,673) crude and 5,347 matched population (TAV: 2,674 and …

Perceptions Of Various Treatment Approaches For Adults And Children With Misophonia, Eleanor E A Smith, Andrew G Guzick, Isabel A Draper, Jane Clinger, Sophie C Schneider, Wayne K Goodman, Jennifer J Brout, Marjin Lijffijt, Eric A Storch

Center for Medical Ethics and Health Policy Staff Publications

Objective: Misophonia is a complex disorder characterized by a heightened reaction to certain sounds and associated stimuli. While there is no uniformly accepted treatment to date, different intervention approaches are being investigated. Individual's perceptions of different misophonia treatment methods may affect compliance and satisfaction with treatment options. We sought to gather data on patient perceptions of currently available misophonia treatments.

Methods: Using an online survey, we collected data about treatment preferences, treatment usage, and diagnosis history from parents of children with misophonia (N = 141) and adults with misophonia (N = 252).

Results: Most respondents were not satisfied with misophonia …

Extracorporeal Membrane Oxygenation Outcomes In Children With Preexisting Neurologic Disorders Or Neurofunctional Disability, Siddhartha A Dante, Megan K Carroll, Derek K Ng, Ankur Patel, Philip C Spinella, Marie E Steiner, Laura L Loftis, Melania M Bembea

Center for Medical Ethics and Health Policy Staff Publications

Objective: Patient selection for pediatric extracorporeal membrane oxygenation (ECMO) support has broadened over the years to include children with pre-existing neurologic morbidities. We aimed to determine the prevalence and nature of pre-ECMO neurologic disorders or disability and investigate the association between pre-ECMO neurologic disorders or disability and mortality and unfavorable neurologic outcome.

Design: Multicenter retrospective observational cohort study.

Setting: Eight hospitals reporting to the Pediatric ECMO Outcomes Registry between October 2011 and June 2019.

Patients: Children younger than 18 years supported with venoarterial or venovenous ECMO.

Interventions: The primary exposure was presence of pre-ECMO neurologic disorders or moderate-to-severe disability, defined …

Association Of Noncontrast Computed Tomography And Perfusion Modalities With Outcomes In Patients Undergoing Late-Window Stroke Thrombectomy, Guilherme B F Porto, Ching-Jen Chen, Sami Al Kasab, Muhammed Amir Essibayi, Eyad Almallouhi, Zachary Hubbard, Reda Chalhoub, Ali Alawieh, Ilko Maier, Marios-Nikos Psychogios, Stacey Q Wolfe, Pascal Jabbour, Ansaar Rai, Robert M Starke, Amir Shaban, Adam Arthur, Joon-Tae Kim, Shinichi Yoshimura, Jonathan Grossberg, Peter Kan, Isabel Fragata, Adam Polifka, Joshua Osbun, Justin Mascitelli, Michael R Levitt, Richard Williamson, Daniele G Romano, Roberto Crosa, Benjamin Gory, Maxim Mokin, Kaustubh S Limaye, Walter Casagrande, Mark Moss, Ramesh Grandhi, Albert Yoo, Alejandro M Spiotta, Min S Park

Department of Neurosurgery Faculty Papers

Importance: There is substantial controversy with regards to the adequacy and use of noncontrast head computed tomography (NCCT) for late-window acute ischemic stroke in selecting candidates for mechanical thrombectomy.

Objective: To assess clinical outcomes of patients with acute ischemic stroke presenting in the late window who underwent mechanical thrombectomy stratified by NCCT admission in comparison with selection by CT perfusion (CTP) and diffusion-weighted imaging (DWI).

Design, setting, and participants: In this multicenter retrospective cohort study, prospectively maintained Stroke Thrombectomy and Aneurysm (STAR) database was used by selecting patients within the late window of acute ischemic stroke and emergent large vessel …

The Safety Of Deutetrabenazine For Chorea In Huntington Disease: An Open-Label Extension Study, Samuel Frank, Claudia Testa, Mary C Edmondson, Jody Goldstein, Elise Kayson, Blair R Leavitt, David Oakes, Christine O'Neill, Christina Vaughan, Jacquelyn Whaley, Nicholas Gross, Mark Forrest Gordon, Juha-Matti Savola, Huntington Study Group/Arc-Hd Investigators And Coordinators

Faculty, Staff and Student Publications

BACKGROUND: Deutetrabenazine is approved in the USA, China, Australia, Israel, Brazil, and South Korea for the treatment of chorea associated with Huntington disease.

OBJECTIVE: We aimed to evaluate the long-term safety and tolerability of deutetrabenazine for the treatment of Huntington disease.

METHODS: This open-label, single-arm, multi-center study included patients who completed a double-blind study (Rollover) and patients who converted overnight from a stable tetrabenazine dose (Switch). Exposure-adjusted incidence rates (adverse events per person-year) were calculated. Efficacy was analyzed using a stable post-titration timepoint (8 weeks). Changes in the Unified Huntington's Disease Rating Scale total motor score and total maximal chorea …

The Association Of Human Leukocyte Antigen Genotyping Among Sudanese Patients With Rheumatoid Arthritis: Reference To Ethnicity, Deborah R Young, Benjamin D Hong, Kristina H Lewis, Silvia R Paz, Bhumi B Bhakta, Mayra Macias, Cecelia L Crawford, Adam Drewnowski, Ming Ji, Darren D Moore, Ernest Shen, Sameer B Murali, Karen J Coleman

Faculty, Staff and Student Publications

OBJECTIVE: This study examined the association of weight loss following bariatric surgery with self-reported sleep quality after accounting for other sleep-related factors.

METHODS: Participants were from the Bariatric Experience Long Term (BELONG) study. Participants completed a survey up to 6 months before surgery and approximately 1 year after surgery. The Pittsburgh Sleep Quality Index (PSQI) was used to measure sleep quality. One-year percentage total weight loss (%TWL) was determined from electronic medical records. Covariates included demographics, Charlson Comorbidity Index, geocoded variables to assess neighborhood quality, and physical activity. The authors assessed the association between %TWL at 1 year and PSQI …

Venous Sinus Stenting For Low Pressure Gradient Stenoses In Idiopathic Intracranial Hypertension, Mehmet Enes Inam, Juan Carlos Martinez-Gutierrez, Matthew J Kole, Francisco Sanchez, Elvira Lekka, Van Thi Thanh Truong, Victor Lopez-Rivera, Faheem G Sheriff, Laura A Zima, Claudia Pedroza, Rosa Tang, Ore-Ofe Adesina, Allison Engstrom, Sunil A Sheth, Peng Roc Chen

Faculty, Staff and Student Publications

BACKGROUND: Medically refractory idiopathic intracranial hypertension (IIH) is frequently treated with venous sinus stenosis stenting with high success rates. Patient selection has been driven almost exclusively by identification of supraphysiological venous pressure gradients across stenotic regions based on theoretical assessment of likelihood of response.

OBJECTIVE: To explore the possibility of benefit in low venous pressure gradient patients.

METHODS: Using a single-center, prospectively maintained registry of patients with IIH undergoing venous stenting, we defined treatment groups by gradient pressures of ≤4, 5 to 8, and >8 mmHg based on the most frequently previously published thresholds for stenting. Baseline demographics, clinical, and …

Surgical Outcomes After Neoadjuvant Nivolumab Or Nivolumab With Ipilimumab In Patients With Non-Small Cell Lung Cancer, Boris Sepesi, Nicolas Zhou, William N William, Heather Y Lin, Cheuk H Leung, Annikka Weissferdt, Kyle G Mitchell, Apar Pataer, Garrett L Walsh, David C Rice, Jack A Roth, Reza J Mehran, Wayne L Hofstetter, Mara B Antonoff, Ravi Rajaram, Marcelo V Negrao, Anne S Tsao, Don L Gibbons, J Jack Lee, John V Heymach, Ara A Vaporciyan, Stephen G Swisher, Tina Cascone

Faculty, Staff and Student Publications

BACKGROUND: Surgical outcomes for non-small cell lung cancer after neoadjuvant immune checkpoint inhibitors continue to be debated. We assessed perioperative outcomes of patients treated with Nivolumab or Nivolumab plus Ipilimumab (NEOSTAR) and compared them with patients treated with chemotherapy or previously untreated patients with stage I-IIIA non-small cell lung cancer.

METHODS: Forty-four patients with stage I to IIIA non-small cell lung cancer (American Joint Committee on Cancer Staging Manual, seventh edition) were randomized to nivolumab (N; 3 mg/kg intravenously on days 1, 15, and 29; n = 23) or nivolumab with ipilimumab (NI; I, 1 mg/kg intravenously on day 1; …

Meaningful Improvement In General Health Outcomes With Guselkumab Treatment For Psoriatic Arthritis: Patient-Reported Outcomes Measurement Information System-29 Results From A Phase 3 Study, Ana-Maria Orbai, Laura C Coates, Atul Deodhar, Philip S Helliwell, Christopher T Ritchlin, Evan Leibowitz, Alexa P Kollmeier, Elizabeth C Hsia, Xie L Xu, Shihong Sheng, Yusang Jiang, Yan Liu, Chenglong Han

Faculty, Staff and Student Publications

OBJECTIVE: The Phase 3 DISCOVER-1 study of guselkumab is the first randomized controlled trial to use Patient-Reported Outcomes Measurement Information System (PROMIS) measures to assess the effects of treatment on general health outcomes in patients with psoriatic arthritis (PsA).

METHODS: Patients (N = 381) with active PsA were randomized 1:1:1 to guselkumab 100 mg every 4 weeks (Q4W); guselkumab 100 mg at Week 0, Week 4, then every 8 weeks (Q8W); or placebo with Week 24 crossover to guselkumab Q4W. The PROMIS-29 Profile contains four items for each of seven domains (anxiety, depression, fatigue, pain interference, physical function, sleep disturbance, …

Low-Dose Dasatinib 50 Mg/Day Versus Standard-Dose Dasatinib 100 Mg/Day As Frontline Therapy In Chronic Myeloid Leukemia In Chronic Phase: A Propensity Score Analysis, Elias Jabbour, Koji Sasaki, Fadi G Haddad, Ghayas C Issa, Jeffrey Skinner, Sara Dellasala, Musa Yilmaz, Alessandra Ferrajoli, Prithviraj Bose, Philip Thompson, Yesid Alvarado, Nitin Jain, Guillermo Garcia-Manero, Koichi Takahashi, Gautam Borthakur, Naveen Pemmaraju, Sherry Pierce, Hagop Kantarjian

Faculty, Staff and Student Publications

Low-dose dasatinib is safe and effective in patients with chronic myeloid leukemia in chronic phase (CML-CP). No randomized trials have compared the outcome with standard-dose dasatinib. This study aims to compare the outcome of patients with CML-CP treated with frontline dasatinib 50 versus 100 mg/day. We analyzed 233 patients with newly diagnosed CML-CP treated with low-dose dasatinib (N = 83) or standard-dose dasatinib (N = 150). Propensity score analysis with 1:1 matching was performed and identified 77 patients in each cohort without significant baseline differences. Response rates were reported as the cumulative incidences of complete cytogenetic response, major molecular response …

American Cochlear Implant Alliance Task Force Guidelines For Clinical Assessment And Management Of Adult Cochlear Implantation For Single-Sided Deafness, Margaret T. Dillon, Armine Kocharyan, Ghazal S. Daher, Matthew L. Carlson, William H. Shapiro, Hillary A. Snapp, Jill B. Firszt

2020-Current year OA Pubs

The indications for cochlear implantation have expanded to include individuals with profound sensorineural hearing loss in the impaired ear and normal hearing (NH) in the contralateral ear, known as single-sided deafness (SSD). There are additional considerations for the clinical assessment and management of adult cochlear implant candidates and recipients with SSD as compared to conventional cochlear implant candidates with bilateral moderate to profound sensorineural hearing loss. The present report reviews the current evidence relevant to the assessment and management of adults with SSD. A systematic review was also conducted on published studies that investigated outcomes of cochlear implant use on …

Association Of Noncontrast Computed Tomography And Perfusion Modalities With Outcomes In Patients Undergoing Late-Window Stroke Thrombectomy, Guilherme B F Porto, Joshua Osbun, Et Al.

2020-Current year OA Pubs

IMPORTANCE: There is substantial controversy with regards to the adequacy and use of noncontrast head computed tomography (NCCT) for late-window acute ischemic stroke in selecting candidates for mechanical thrombectomy.

OBJECTIVE: To assess clinical outcomes of patients with acute ischemic stroke presenting in the late window who underwent mechanical thrombectomy stratified by NCCT admission in comparison with selection by CT perfusion (CTP) and diffusion-weighted imaging (DWI).

DESIGN, SETTING, AND PARTICIPANTS: In this multicenter retrospective cohort study, prospectively maintained Stroke Thrombectomy and Aneurysm (STAR) database was used by selecting patients within the late window of acute ischemic stroke and emergent large vessel …

Serum High Mobility Group Box-1 Levels Associated With Cardiovascular Events After Lower Extremity Revascularization: A Prospective Study Of A Diabetic Population, Maria Margherita Rando, Federico Biscetti, Andrea Leonardo Cecchini, Elisabetta Nardella, Maria Anna Nicolazzi, Flavia Angelini, Roberto Iezzi, Luis H. Eraso, Paul J Dimuzio, Dario Pitocco, Antonio Gasbarrini, Massimo Massetti, Andrea Flex

Department of Surgery Faculty Papers

Background: Peripheral arterial disease (PAD) is one of the most disabling cardiovascular complications of type 2 diabetes mellitus and is indeed associated with a high risk of cardiovascular and limb adverse events. High mobility group box-1 (HMGB-1) is a nuclear protein involved in the inflammatory response that acts as a pro-inflammatory cytokine when released into the extracellular space. HMBG-1 is associated with PAD in diabetic patients. The aim of this study was to evaluate the association between serum HMGB-1 levels and major adverse cardiovascular events (MACE) and major adverse limb events (MALE) after lower-extremity endovascular revascularization (LER) in a group …

Sex-Specific Considerations In Degenerative Aortic Stenosis For Female-Tailored Transfemoral Aortic Valve Implantation Management, Giulia Masiero, Valeria Paradies, Anna Franzone, Barbara Bellini, Chiara De Biase, Nicole Karam, Francesca Sanguineti, Mamas A Mamas, Hélène Eltchaninoff, Chiara Fraccaro, Battistina Castiglioni, Tiziana Attisano, Giovanni Esposito, Alaide Chieffo

Department of Medicine Faculty Papers

The impact of sex on pathophysiological processes, clinical presentation, treatment options, as well as outcomes of degenerative aortic stenosis remain poorly understood. Female patients are well represented in transfemoral aortic valve implantation (TAVI) trials and appear to derive favorable outcomes with TAVI. However, higher incidences of major bleeding, vascular complications, and stroke have been reported in women following TAVI. The anatomical characteristics and pathophysiological features of aortic stenosis in women might guide a tailored planning of the percutaneous approach. We highlight whether a sex-based TAVI management strategy might impact on clinical outcomes. This review aimed to evaluate the impact of …

Indications For Absorbable Steroid-Eluting Sinus Implants: Viewpoint Via The Delphi Method, Victoria S Lee, Prayag Patel, Daniel O'Brien, George A Scangas, Raewyn G Campbell, Rakesh Chandra, Greg E Davis, Joseph K Han, Christopher H Le, Jivianne Lee, Amber U Luong, David M Poetker, Hassan Ramadan, Michael Setzen, Kristine Smith, Sarah Wise, Jennifer Villwock, Elisabeth Ference

Faculty, Staff and Student Publications

Absorbable steroid-eluting sinus implants provide targeted corticosteroid release over a sustained period and are designed to prevent both undesirable adhesion formation and sinus ostia restenosis. Here, we highlight the key evidence of these implants to date and query a group of experts via a Delphi process on the indications and optimal timing for intraoperative or in-office placement of these implants. Six of a total of 12 statements reached consensus and were accepted. Overall, experts largely agree that intraoperative or in-office use of steroid-eluting stents could be considered for patients: (1) who are diabetic or intolerant of oral steroids, (2) undergoing …

Comparative Safety And Effectiveness Of Roux-En-Y Gastric Bypass And Sleeve Gastrectomy For Weight Loss And Type 2 Diabetes Across Race And Ethnicity In The Pcornet Bariatric Study Cohort, Karen J Coleman, Robert Wellman, Stephanie L Fitzpatrick, Molly B Conroy, Callie Hlavin, Kristina H Lewis, R Yates Coley, Kathleen M Mctigue, Jonathan N Tobin, Corrigan L Mcbride, Jay R Desai, Jeanne M Clark, Sengwee Toh, Jessica L Sturtevant, Casie E Horgan, Meredith C Duke, Neely Williams, Jane Anau, Michael A Horberg, Marc P Michalsky, Andrea J Cook, David E Arterburn, Caroline M Apovian, Pcornet Bariatric Study Collaborative

Faculty, Staff and Student Publications

IMPORTANCE: Bariatric surgery is the most effective treatment for severe obesity; yet it is unclear whether the long-term safety and comparative effectiveness of these operations differ across racial and ethnic groups.

OBJECTIVE: To compare outcomes of Roux-en-Y gastric bypass (RYGB) and sleeve gastrectomy (SG) across racial and ethnic groups in the National Patient-Centered Clinical Research Network (PCORnet) Bariatric Study.

DESIGN, SETTING, AND PARTICIPANTS: This was a retrospective, observational, comparative effectiveness cohort study that comprised 25 health care systems in the PCORnet Bariatric Study. Patients were adults and adolescents aged 12 to 79 years who underwent a primary (first nonrevisional) RYGB …

Effect Of Dexamethasone On Dyspnoea In Patients With Cancer (Abcd): A Parallel-Group, Double-Blind, Randomised, Controlled Trial, David Hui, Veronica Puac, Zeena Shelal, Rony Dev, Sandra K Hanneman, Kristofer Jennings, Hilary Ma, Diana L Urbauer, Sanjay Shete, Frank Fossella, Zhongxing Liao, George Blumenschein, Joe Y Chang, Michael O'Reilly, Saumil J Gandhi, Anne Tsao, Donald A Mahler, Eduardo Bruera

Faculty, Staff and Student Publications

BACKGROUND: Systemic corticosteroids are commonly prescribed for palliation of dyspnoea in patients with cancer, despite scarce evidence to support their use. We aimed to assess the effect of high-dose dexamethasone versus placebo on cancer-related dyspnoea.

METHODS: This double-blind, multi-site, parallel group randomized trial enrolled ambulatory patients with cancer, age ≥18, average dyspnea intensity over the past week ≥4/10 in a 0–10 point numeric rating scale and randomly assigned them to receive dexamethasone 8 mg orally every 12 hours for 7 days followed by 4 mg orally every 12 hours for 7 days or matching placebo capsules. Pharmacists conducted permuted block …

Health-Related Quality Of Life In Older Patients With Heart Failure From Before To Early After Advanced Surgical Therapies: Findings From The Sustain-It Study, Kathleen L. Grady, Justin Hartupee, Et Al.

2020-Current year OA Pubs

BACKGROUND: Restoring health-related quality of life (HRQOL) is a therapeutic goal for older patients with advanced heart failure. We aimed to describe change in HRQOL in older patients (60-80 years) awaiting heart transplantation (HT) with or without pretransplant mechanical circulatory support (MCS) or scheduled for long-term MCS, if ineligible for HT, from before to 6 months after these surgeries and identify factors associated with change.

METHODS: Patients from 13 US sites completed the EuroQol 5-dimension 3L questionnaire and Kansas City Cardiomyopathy Questionnaire-12 at baseline and 3 and 6 months after HT or long-term MCS. Analyses included univariate comparisons and multivariable …

Glycemia Reduction In Type 2 Diabetes - Glycemic Outcomes, David M Nathan, John M Lachin, Ashok Balasubramanyam, Henry B Burch, John B Buse, Nicole M Butera, Robert M Cohen, Jill P Crandall, Steven E Kahn, Heidi Krause-Steinrauf, Mary E Larkin, Neda Rasouli, Margaret Tiktin, Deborah J Wexler, Naji Younes

Faculty, Staff and Students Publications

BACKGROUND: The comparative effectiveness of glucose-lowering medications for use with metformin to maintain target glycated hemoglobin levels in persons with type 2 diabetes is uncertain.

METHODS: In this trial involving participants with type 2 diabetes of less than 10 years' duration who were receiving metformin and had glycated hemoglobin levels of 6.8 to 8.5%, we compared the effectiveness of four commonly used glucose-lowering medications. We randomly assigned participants to receive insulin glargine U-100 (hereafter, glargine), the sulfonylurea glimepiride, the glucagon-like peptide-1 receptor agonist liraglutide, or sitagliptin, a dipeptidyl peptidase 4 inhibitor. The primary metabolic outcome was a glycated hemoglobin level, …

Mri-Based Digital Models Forecast Patient-Specific Treatment Responses To Neoadjuvant Chemotherapy In Triple-Negative Breast Cancer, Chengyue Wu, Angela M Jarrett, Zijian Zhou, Nabil Elshafeey, Beatriz E Adrada, Rosalind P Candelaria, Rania M M Mohamed, Medine Boge, Lei Huo, Jason B White, Debu Tripathy, Vicente Valero, Jennifer K Litton, Clinton Yam, Jong Bum Son, Jingfei Ma, Gaiane M Rauch, Thomas E Yankeelov

Faculty, Staff and Student Publications

Triple-negative breast cancer (TNBC) is persistently refractory to therapy, and methods to improve targeting and evaluation of responses to therapy in this disease are needed. Here, we integrate quantitative MRI data with biologically based mathematical modeling to accurately predict the response of TNBC to neoadjuvant systemic therapy (NAST) on an individual basis. Specifically, 56 patients with TNBC enrolled in the ARTEMIS trial (NCT02276443) underwent standard-of-care doxorubicin/cyclophosphamide (A/C) and then paclitaxel for NAST, where dynamic contrast-enhanced MRI and diffusion-weighted MRI were acquired before treatment and after two and four cycles of A/C. A biologically based model was established to …

Remission Of Liquid Tumors And Sars-Cov-2 Infection: A Literature Review, Dong Ho Shin, Andrew Gillard, Arie Van Wieren, Candelaria Gomez-Manzano, Juan Fueyo

Faculty, Staff and Student Publications

The coronavirus disease 2019 (COVID-19) pandemic has produced a new global challenge for patients with cancer. The disease and the immunosuppression induced by cancer therapies have generated a perfect storm of conditions to increase the severity of the symptoms and worsen the prognosis. However, a few clinical reports showcased the power of viruses to induce remission in some patients suffering from liquid tumors. Here, we reviewed six cases of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) that resulted in cancer remission, simultaneously highlighting the strengths and the unique challenges of oncolytic virotherapy. Virotherapy has become a special case of cancer …

Bridging Thrombolysis In Atrial Fibrillation Stroke Is Associated With Increased Hemorrhagic Complications Without Improved Outcomes, Feras Akbik, Ali Alawieh, Laurie Dimisko, Brian M. Howard, C Michael Cawley, Frank C. Tong, Fadi Nahab, Owen B. Samuels, Ilko Maier, Wuwei Feng, Nitin Goyal, Robert M. Starke, Ansaar Rai, Kyle M. Fargen, Marios N. Psychogios, Pascal Jabbour, Reade De Leacy, Saleh G. Keyrouz, Travis M. Dumont, Peter Kan, Jan Liman, Adam S. Arthur, Stacey Q. Wolfe, J. Mocco, Roberto Javier Crosa, W Christopher Fox, Benjamin Gory, Alejandro M. Spiotta, Jonathan A. Grossberg

Department of Neurosurgery Faculty Papers

BACKGROUND: Atrial fibrillation (AF) associated ischemic stroke is associated with worse functional outcomes, less effective recanalization, and increased rates of hemorrhagic complications after intravenous thrombolysis (IVT). Conversely, AF is not associated with hemorrhagic complications or functional outcomes in patients undergoing mechanical thrombectomy (MT). This differential effect of MT and IVT in AF associated stroke raises the question of whether bridging thrombolysis increases hemorrhagic complications in AF patients undergoing MT.

METHODS: This international cohort study of 22 comprehensive stroke centers analyzed patients with large vessel occlusion (LVO) undergoing MT between June 1, 2015 and December 31, 2020. Patients were divided into …

The Core Rehabilitation Outcome Set For Single-Sided Deafness (Crosssd) Study: International Consensus On Outcome Measures For Trials Of Interventions For Adults With Single-Sided Deafness, Roulla Katiri, Deborah A Hall, Derek J Hoare, Kathryn Fackrell, Adele Horobin, Nicholas Hogan, Nóra Buggy, Paul H Van De Heyning, Jill B Firszt, Iain A Bruce, Pádraig T Kitterick, Core Rehabilitation Outcome Set For Single-Sided Deafness (Crosssd) Initiative

2020-Current year OA Pubs

BACKGROUND: Single-sided deafness (SSD) has functional, psychological, and social consequences. Interventions for adults with SSD include hearing aids and auditory implants. Benefits and harms (outcome domains) of these interventions are until now reported inconsistently in clinical trials. Inconsistency in reporting outcome measures prevents meaningful comparisons or syntheses of trial results. The Core Rehabilitation Outcome Set for Single-Sided Deafness (CROSSSD) international initiative used structured communication techniques to achieve consensus among healthcare users and professionals working in the field of SSD. The novel contribution is a set of core outcome domains that experts agree are critically important to assess in all clinical …

Outcomes From A Tertiary Care Center Using A Catheter Thrombectomy System For Managing Acute Iliofemoral Deep Vein Thrombosis., Michael A Jolly, Marie M Lockhart, Deep Shah, Christopher M Huff, Elizabeth A Valenti, John A Phillips, Samih Bittar, Charles F Botti, Raghu Kolluri, Mitchell J Silver

OhioHealth Research Institute Articles

OBJECTIVE: The aim of the present study was to report a large, single-center experience using the ClotTriever thrombectomy system (Inari Medical, Irvine, CA) for the management of acute iliofemoral (IF) deep vein thrombosis (DVT). One limitation of all endovascular devices for the treatment of acute IF-DVT has been the inability to completely remove all acute thrombus and the need for adjunctive thrombolysis with its attendant risk of bleeding complications.

METHODS: A single-center retrospective review of consecutive patients with acute IF-DVT treated with the ClotTriever thrombectomy system (Inari Medical) is reported. Procedural efficacy was evaluated by an independent core imaging laboratory …

Efficacy And Safety Of Ensovibep For Adults Hospitalized With Covid-19 : A Randomized Controlled Trial, Christina Barkauskas, Eleftherios Mylonakis, Garyfallia Poulakou, Barnaby E Young, David M Vock, Lianne Siegel, Nicole Engen, Greg Grandits, Nilima R Mosaly, Andrew M Vekstein, Ralph Rogers, Fadi Shehadeh, Matthew Kaczynski, Evangelia K Mylona, Konstantinos N Syrigos, Vasiliki Rapti, David C Lye, Diong Shiau Hui, Lindsay Leither, Kirk U Knowlton, Mamta K Jain, Rubria Marines-Price, Alice Osuji, J Scott Overcash, Ioannis Kalomenidis, Zafeiria Barmparessou, Michael Waters, Karla Zepeda, Peter Chen, Sam Torbati, Francis Kiweewa, Nicholus Sebudde, Eyad Almasri, Alyssa Hughes, Sanjay R Bhagani, Alison Rodger, Uriel Sandkovsky, Robert L Gottlieb, Eriobu Nnakelu, Barbara Trautner, Vidya Menon, Joseph Lutaakome, Michael Matthay, Philip Robinson, Konstantinos Protopapas, Nikolaos Koulouris, Ivan Kimuli, Amiran Baduashvili, Dominique L Braun, Huldrych F Günthard, Srikanth Ramachandruni, Robert Kidega, Kami Kim, Timothy J Hatlen, Andrew N Phillips, Daniel D Murray, Tomas O Jensen, Maria L Padilla, Evan X Accardi, Katy Shaw-Saliba, Robin L Dewar, Marc Teitelbaum, Ven Natarajan, Sylvain Laverdure, Helene C Highbarger, M Tauseef Rehman, Susan Vogel, David Vallée, Page Crew, Negin Atri, Adam J Schechner, Sarah Pett, Fleur Hudson, Jonathan Badrock, Giota Touloumi, Samuel M Brown, Wesley H Self, Crystal M North, Adit A Ginde, Christina C Chang, Anthony Kelleher, Stephanie Nagy-Agren, Shikha Vasudeva, David Looney, Hien H Nguyen, Adriana Sánchez, Amy C Weintrob, Birgit Grund, Shweta Sharma, Cavan S Reilly, Roger Paredes, Agnieszka Bednarska, Norman P Gerry, Abdel G Babiker, Victoria J Davey, Annetine C Gelijns, Elizabeth S Higgs, Virginia Kan, Gail Matthews, B Taylor Thompson, Philippe Legenne, Richa Chandra, H Clifford Lane, James D Neaton, Jens D Lundgren

Faculty, Staff and Students Publications

BACKGROUND: Ensovibep (MP0420) is a designed ankyrin repeat protein, a novel class of engineered proteins, under investigation as a treatment of SARS-CoV-2 infection.

OBJECTIVE: To investigate if ensovibep, in addition to remdesivir and other standard care, improves clinical outcomes among patients hospitalized with COVID-19 compared with standard care alone.

DESIGN: Double-blind, randomized, placebo-controlled, clinical trial. (ClinicalTrials.gov: NCT04501978).

SETTING: Multinational, multicenter trial.

PARTICIPANTS: Adults hospitalized with COVID-19.

INTERVENTION: Intravenous ensovibep, 600 mg, or placebo.

MEASUREMENTS: Ensovibep was assessed for early futility on the basis of pulmonary ordinal scores at day 5. The primary outcome was time to sustained recovery through day …

Transcatheter Aortic Valve Implantation For Severe Aortic Stenosis And Large Membranous Interventricular Septal Aneurysm, Maheedhar Gedela, Tomasz Stys, Terezia Petraskova, Adam Stys

The Texas Heart Institute Journal

No abstract provided.