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1. Regulatory T Cell Amelioration of Graft-versus-Host Disease following Allogeneic/Xenogeneic Hematopoietic Stem Cell Transplantation Using Mobilized Mouse and Human Peripheral Blood Donors.

Author

Barreras, Henry, Copsel, Sabrina, Bader, Cameron, Ding, Ying, Wolf, Dietlinde, Cash, Charles, Stacey, Caleb, Benjamin, Cara, Seavey, Mathew, Wolf, Jeffrey, Jasuja, Rahul, Pfeiffer, Brent, Hill, Geoffrey, Jurecic, Roland, Malek, Thomas, Levy, Robert, and Komanduri, Krishna

Subjects
Allogeneic Hematopoietic Stem Cell Transplantation, GVT, Xenotransplantation, Graft-versus-Host Disease, Mobilization, TL1A, Tregs, IL-2, Humans, Animals, Mice, T-Lymphocytes, Regulatory, Blood Donors, Hematopoietic Stem Cell Mobilization, Mice, Inbred C3H, Mice, Inbred NOD, Heterocyclic Compounds, Hematopoietic Stem Cell Transplantation, Graft vs Host Disease, Proteins
Abstract

The present studies examined experimental transplant outcomes using mobilized peripheral blood from mice and humans together with FoxP3+Treg cells. Donor mice were treated with filgrastim and / or plerixafor and their peripheral blood (PB) displayed significant elevations in hematopoietic stem and progenitor populations. Some of these PB donors were concurrently administered a Treg expansion strategy consisting of a TL1A-Ig fusion protein low dose rIL-2. A significant increase (4-5x) in the frequency Tregs occurred during mobilization. C3H.SW PB was collected from mobilized and Treg unexpanded (TrUM) or mobilized and Treg expanded (TrEM) donors and transplanted into MHC-matched B6 (H2b) recipients. Recipients of TrEM, exhibited significantly reduced weight loss and clinical GVHD scores compared to recipients of TrUM. Notably, recipients of TrEM exhibited comparable GVL activity to TrUM recipients against leukemia levels. Next, huTregs (CD4+CD25+CD127lo) from a healthy human PB mobilized donor were expanded ex-vivo prior to transplant into NSG/ NOD-scid IL2Rgammanull mice. We found that treatment with ex-vivo expanded huTregs resulted in significant reduction of lethality and clinical xGVHD scores. Notably, post-transplant, PB huTregs levels remained elevated and the frequency of huCD4+Tconv and CD8+ cells was diminished supporting the improved xGVHD outcomes. These findings demonstrated that the use of mPB containing elevated Treg levels significantly reduced GVHD following MUD and MHC-mismatched mouse HSCT without loss of GVL activity. Moreover, utilizing ex-vivo expanded huTregs from a mobilized PB donor and added back to donor PB ameliorated xGVHD. In total, these studies support the notion that in vivo or ex-vivo manipulation of donor Tregs together with mobilized peripheral blood could provide therapeutic approaches to improve aHSCT outcomes.

Published
2023

2. Intraoperative molecular imaging: 3rd biennial clinical trials update

Author

Bou-Samra, Patrick, Muhammad, Najib, Chang, Austin, Karsalia, Ritesh, Azari, Feredun, Kennedy, Gregory, Stummer, Walter, Tanyi, Janos, Martin, Linda, Vahrmeijer, Alexander, Smith, Barbara, Rosenthal, Eben, Wagner, Patrick, Rice, David, Lee, Amy, Abdelhafeez, Abdelhafeez, Malek, Marcus M, Kohanbash, Gary, Edwards, Wilson Barry, Henderson, Eric, Skjøth-Rasmussen, Jane, Orosco, Ryan, Gibbs, Summer, Farnam, Richard W, Shankar, Lalitha, Sumer, Baran, Kumar, Anand TN, Marcu, Laura, Li, Lei, Greuv, Victor, Delikatny, Edward J, Lee, John YK, and Singhal, Sunil

Subjects
Biomedical and Clinical Sciences, Clinical Sciences, Oncology and Carcinogenesis, Clinical Trials and Supportive Activities, Clinical Research, Cancer, Humans, Child, Neoplasms, Contrast Media, Molecular Imaging, Coloring Agents, intraoperative molecular imaging, contrast agents, clinically significant events, precision surgery, Optical Physics, Biomedical Engineering, Opthalmology and Optometry, Optics, Ophthalmology and optometry, Biomedical engineering, Atomic, molecular and optical physics
Abstract

SignificanceThis third biennial intraoperative molecular imaging (IMI) conference shows how optical contrast agents have been applied to develop clinically significant endpoints that improve precision cancer surgery.AimNational and international experts on IMI presented ongoing clinical trials in cancer surgery and preclinical work. Previously known dyes (with broader applications), new dyes, novel nonfluorescence-based imaging techniques, pediatric dyes, and normal tissue dyes were discussed.ApproachPrincipal investigators presenting at the Perelman School of Medicine Abramson Cancer Center's third clinical trials update on IMI were selected to discuss their clinical trials and endpoints.ResultsDyes that are FDA-approved or currently under clinical investigation in phase 1, 2, and 3 trials were discussed. Sections on how to move benchwork research to the bedside were also included. There was also a dedicated section for pediatric dyes and nonfluorescence-based dyes that have been newly developed.ConclusionsIMI is a valuable adjunct in precision cancer surgery and has broad applications in multiple subspecialties. It has been reliably used to alter the surgical course of patients and in clinical decision making. There remain gaps in the utilization of IMI in certain subspecialties and potential for developing newer and improved dyes and imaging techniques.

Published
2023

3. Prospective study on embolization of intracranial aneurysms with the pipeline device (PREMIER study): 3-year results with the application of a flow diverter specific occlusion classification

Author

Hanel, Ricardo A, Cortez, Gustavo M, Lopes, Demetrius Klee, Nelson, Peter Kim, Siddiqui, Adnan H, Jabbour, Pascal, Pereira, Vitor Mendes, István, Istvan Szikora, Zaidat, Osama O, Bettegowda, Chetan, Colby, Geoffrey P, Mokin, Maxim, Schirmer, Clemens M, Hellinger, Frank R, Given, Curtis, Krings, Timo, Taussky, Philipp, Toth, Gabor, Fraser, Justin F, Chen, Michael, Priest, Ryan, Kan, Peter, Fiorella, David, Frei, Donald, Aagaard-Kienitz, Beverly, Diaz, Orlando, Malek, Adel M, Cawley, C Michael, Puri, Ajit S, and Kallmes, David F

Subjects
Biomedical and Clinical Sciences, Clinical Sciences, Hematology, Clinical Research, Stroke, Neurosciences, Clinical Trials and Supportive Activities, Humans, Cerebral Angiography, Embolization, Therapeutic, Follow-Up Studies, Intracranial Aneurysm, Prospective Studies, Retrospective Studies, Treatment Outcome, aneurysm, flow diverter, intervention, Clinical sciences
Abstract

BackgroundThe pipeline embolization device (PED; Medtronic) has presented as a safe and efficacious treatment for small- and medium-sized intracranial aneurysms. Independently adjudicated long-term results of the device in treating these lesions are still indeterminate. We present 3-year results, with additional application of a flow diverter specific occlusion scale.MethodsPREMIER (prospective study on embolization of intracranial aneurysms with pipeline embolization device) is a prospective, single-arm trial. Inclusion criteria were patients with unruptured wide-necked intracranial aneurysms ≤12 mm. Primary effectiveness (complete aneurysm occlusion) and safety (major neurologic event) endpoints were independently monitored and adjudicated.ResultsAs per the protocol, of 141 patients treated with a PED, 25 (17.7%) required angiographic follow-up after the first year due to incomplete aneurysm occlusion. According to the Core Radiology Laboratory review, three (12%) of these patients progressed to complete occlusion, with an overall rate of complete aneurysm occlusion at 3 years of 83.3% (115/138). Further angiographic evaluation using the modified Cekirge-Saatci classification demonstrated that complete occlusion, neck residual, or aneurysm size reduction occurred in 97.1%. The overall combined safety endpoint at 3 years was 2.8% (4/141), with only one non-debilitating major event occurring after the first year. There was one case of aneurysm recurrence but no cases of delayed rupture in this series.ConclusionsThe PED device presents as a safe and effective modality in treating small- and medium-sized intracranial aneurysms. The application of a flow diverter specific occlusion classification attested the long-term durability with higher rate of successful aneurysm occlusion and no documented aneurysm rupture.Trial registrationNCT02186561.

Published
2023

4. Dose‐response relationship between late‐life physical activity and incident dementia: A pooled analysis of 10 cohort studies of memory in an international consortium

Author

Wu, Wanqing, Ding, Ding, Zhao, Qianhua, Xiao, Zhenxu, Luo, Jianfeng, Ganguli, Mary, Hughes, Tiffany F, Jacobsen, Erin, Haan, Mary N, Dang, Kristine, Lima‐Costa, Maria Fernanda, Blay, Sergio Luis, Castro‐Costa, Erico, Ng, Tze Pin, Gwee, Xinyi, Gao, Qi, Gureje, Oye, Ojagbemi, Akin, Bello, Toyin, Shahar, Suzana, Ludin, Arimi Fitri Mat, Rivan, Nurul Fatin Malek, Scarmeas, Nikolaos, Anastasiou, Costas A, Yannakoulia, Mary, Brodaty, Henry, Crawford, John D, Lipton, Richard B, Derby, Carol A, Katz, Mindy J, Lipnicki, Darren M, Sachdev, Perminder S, and Consortium, for Cohort Studies of Memory in an International

Subjects
Biomedical and Clinical Sciences, Clinical Sciences, Acquired Cognitive Impairment, Aging, Rehabilitation, Clinical Research, Dementia, Prevention, Brain Disorders, Neurological, Humans, Aged, Cohort Studies, Proportional Hazards Models, Risk Factors, cohort, dementia, dose-response, physical activity, pooled analysis, population-based, for Cohort Studies of Memory in an International Consortium, Neurosciences, Geriatrics, Clinical sciences, Biological psychology
Abstract

IntroductionThough consistent evidence suggests that physical activity may delay dementia onset, the duration and amount of activity required remains unclear.MethodsWe harmonized longitudinal data of 11,988 participants from 10 cohorts in eight countries to examine the dose-response relationship between late-life physical activity and incident dementia among older adults.ResultsUsing no physical activity as a reference, dementia risk decreased with duration of physical activity up to 3.1 to 6.0 hours/week (hazard ratio [HR] 0.88, 95% confidence interval [CI] 0.67 to 1.15 for 0.1 to 3.0 hours/week; HR 0.68, 95% CI 0.52 to 0.89 for 3.1 to 6.0 hours/week), but plateaued with higher duration. For the amount of physical activity, a similar pattern of dose-response curve was observed, with an inflection point of 9.1 to 18.0 metabolic equivalent value (MET)-hours/week (HR 0.92, 95% CI 0.70 to 1.22 for 0.1 to 9.0 MET-hours/week; HR 0.70, 95% CI 0.53 to 0.93 for 9.1 to 18.0 MET-hours/week).DiscussionThis cross-national analysis suggests that performing 3.1 to 6.0 hours of physical activity and expending 9.1 to 18.0/MET-hours of energy per week may reduce dementia risk.

Published
2023

5. Does senescence play a role in age-related macular degeneration?

Author

Malek, Goldis, Campisi, Judith, Kitazawa, Koji, Webster, Corey, Lakkaraju, Aparna, and Skowronska-Krawczyk, Dorota

Subjects
Age-related macular degeneration, Aging, Retinal pigment epithelium, Senescence, Middle Aged, Humans, Aged, Retinal Pigment Epithelium, Macular Degeneration, Cellular Senescence
Abstract

Advanced age is the most established risk factor for developing age-related macular degeneration (AMD), one of the leading causes of visual impairment in the elderly, in Western and developed countries. Similarly, after middle age, there is an exponential increase in pathologic molecular and cellular events that can induce senescence, traditionally defined as an irreversible loss of the cells ability to divide and most recently reported to also occur in select post-mitotic and terminally differentiated cells, such as neurons. Together these facts raise the question as to whether or not cellular senescence, may play a role in the development of AMD. A number of studies have reported the effect of ocular-relevant inducers of senescence using primarily in vitro models of poorly polarized, actively dividing retinal pigment epithelial (RPE) cell lines. However, in interpretating the data, the fidelity of these culture models to the RPE in vivo, must be considered. Fewer studies have explored the presence and/or impact of senescent cells in in vivo models that present with phenotypic features of AMD, leaving this an open field for further investigation. The goal of this review is to discuss current thoughts on the potential role of senescence in AMD development and progression, with consideration of the model systems used and their relevance to human disease.

Published
2022

6. Cell culture models to study retinal pigment epithelium-related pathogenesis in age-related macular degeneration

Author

Bharti, Kapil, den Hollander, Anneke I, Lakkaraju, Aparna, Sinha, Debasish, Williams, David S, Finnemann, Silvia C, Bowes-Rickman, Catherine, Malek, Goldis, and D'Amore, Patricia A

Subjects
Biomedical and Clinical Sciences, Ophthalmology and Optometry, Aging, Human Fetal Tissue, Stem Cell Research - Induced Pluripotent Stem Cell - Human, Neurosciences, Macular Degeneration, Stem Cell Research, Eye Disease and Disorders of Vision, Neurodegenerative, Stem Cell Research - Induced Pluripotent Stem Cell, 2.1 Biological and endogenous factors, Aetiology, Eye, Adult, Aged, Animals, Cell Culture Techniques, Geographic Atrophy, Humans, Induced Pluripotent Stem Cells, Mice, Retinal Pigment Epithelium, Swine, Retinal pigment epithelium, ARPE19, Primary cells, iPSC-RPE, Organ-on-a-Chip, Complement system, Medical Biochemistry and Metabolomics, Opthalmology and Optometry, Ophthalmology & Optometry, Ophthalmology and optometry
Abstract

Age-related macular degeneration (AMD) is a disease that affects the macula - the central part of the retina. It is a leading cause of irreversible vision loss in the elderly. AMD onset is marked by the presence of lipid- and protein-rich extracellular deposits beneath the retinal pigment epithelium (RPE), a monolayer of polarized, pigmented epithelial cells located between the photoreceptors and the choroidal blood supply. Progression of AMD to the late nonexudative "dry" stage of AMD, also called geographic atrophy, is linked to progressive loss of areas of the RPE, photoreceptors, and underlying choriocapillaris leading to a severe decline in patients' vision. Differential susceptibility of macular RPE in AMD and the lack of an anatomical macula in most lab animal models has promoted the use of in vitro models of the RPE. In addition, the need for high throughput platforms to test potential therapies has driven the creation and characterization of in vitro model systems that recapitulate morphologic and functional abnormalities associated with human AMD. These models range from spontaneously formed cell line ARPE19, immortalized cell lines such as hTERT-RPE1, RPE-J, and D407, to primary human (fetal or adult) or animal (mouse and pig) RPE cells, and embryonic and induced pluripotent stem cell (iPSC) derived RPE. Hallmark RPE phenotypes, such as cobblestone morphology, pigmentation, and polarization, vary significantly betweendifferent models and culture conditions used in different labs, which would directly impact their usability for investigating different aspects of AMD biology. Here the AMD Disease Models task group of the Ryan Initiative for Macular Research (RIMR) provides a summary of several currently used in vitro RPE models, historical aspects of their development, RPE phenotypes that are attainable in these models, their ability to model different aspects of AMD pathophysiology, and pros/cons for their use in the RPE and AMD fields. In addition, due to the burgeoning use of iPSC derived RPE cells, the critical need for developing standards for differentiating and rigorously characterizing RPE cell appearance, morphology, and function are discussed.

Published
2022

7. Perceived Utility of Genomic Sequencing: Qualitative Analysis and Synthesis of a Conceptual Model to Inform Patient-Centered Instrument Development

Author

Smith, Hadley Stevens, Morain, Stephanie R, Robinson, Jill Oliver, Canfield, Isabel, Malek, Janet, Rubanovich, Caryn Kseniya, Bloss, Cinnamon S, Ackerman, Sara L, Biesecker, Barbara, Brothers, Kyle B, Goytia, Crispin N, Horowitz, Carol R, Knight, Sara J, Koenig, Barbara, Kraft, Stephanie A, Outram, Simon, Rini, Christine, Shipman, Kelly J, Waltz, Margaret, Wilfond, Benjamin, and McGuire, Amy L

Subjects
Clinical Research, Basic Behavioral and Social Science, Behavioral and Social Science, Mental Health, Good Health and Well Being, Adult, Child, Emotions, Genomics, Humans, Models, Theoretical, Parents, Patient-Centered Care, Qualitative Research, Medical and Health Sciences
Abstract

Background and objectivesSuccessful clinical integration of genomic sequencing (GS) requires evidence of its utility. While GS potentially has benefits (utilities) or harms (disutilities) across multiple domains of life for both patients and their families, there is as yet no empirically informed conceptual model of these effects. Our objective was to develop an empirically informed conceptual model of perceived utility of GS that captures utilities and disutilities for patients and their families across diverse backgrounds.MethodsWe took a patient-centered approach, in which we began with a review of existing literature followed by collection of primary interview data. We conducted semi-structured interviews to explore types of utility in a clinically and sociopolitically diverse sample of 60 adults from seven Clinical Sequencing Evidence-Generating Research (CSER) consortium projects. Interviewees had either personally received, or were parents of a child who had received, GS results. Qualitative data were analyzed using thematic analysis. Findings from interviews were integrated with existing literature on clinical and personal utility to form the basis of an initial conceptual model that was refined based on expert review and feedback.ResultsFive key utility types that have been previously identified in qualitative literature held up as primary domains of utility and disutility in our diverse sample. Interview data were used to specify and organize subdomains of an initial conceptual model. After expert refinement, the five primary domains included in the final model are clinical, emotional, behavioral, cognitive, and social, and several subdomains are specified within each.ConclusionWe present an empirically informed conceptual model of perceived utility of GS. This model can be used to guide development of instruments for patient-centered outcome measurement that capture the range of relevant utilities and disutilities and inform clinical implementation of GS.

Published
2022

8. Acute ischaemic stroke associated with SARS-CoV-2 infection in North America

Author

Dmytriw, Adam A, Dibas, Mahmoud, Phan, Kevin, Efendizade, Aslan, Johanna, Ospel, Schirmer, Clemens, Settecase, Fabio, Heran, Manraj KS, Kühn, Anna Luisa, Puri, Ajit S, Menon, Bijoy K, Sivakumar, Sanjeev, Mowla, Askan, Vela-Duarte, Daniel, Linfante, Italo, Dabus, Guilherme C, Regenhardt, Robert W, D'Amato, Salvatore, Rosenthal, Joseph A, Zha, Alicia, Talukder, Nafee, Sheth, Sunil A, Hassan, Ameer E, Cooke, Daniel L, Leung, Lester Y, Malek, Adel M, Voetsch, Barbara, Sehgal, Siddharth, Wakhloo, Ajay K, Goyal, Mayank, Wu, Hannah, Cohen, Jake, Ghozy, Sherief, Turkel-Parella, David, Farooq, Zerwa, Vranic, Justin, Rabinov, James D, Stapleton, Christopher J, Minhas, Ramandeep, Velayudhan, Vinodkumar, Chaudhry, Zeshan Ahmed, Xavier, Andrew, Bullrich, Maria Bres, Pandey, Sachin, Sposato, Luciano A, Johnson, Stephen A, Gupta, Gaurav, Khandelwal, Priyank, Ali, Latisha, Liebeskind, David S, Farooqui, Mudassir, Ortega-Gutierrez, Santiago, Nahab, Fadi, Jillella, Dinesh V, Chen, Karen, Aziz-Sultan, Mohammad Ali, Abdalkader, Mohamad, Kaliaev, Artem, Nguyen, Thanh N, Haussen, Diogo C, Nogueira, Raul G, Haq, Israr Ul, Zaidat, Osama O, Sanborn, Emma, Leslie-Mazwi, Thabele M, Patel, Aman B, Siegler, James E, and Tiwari, Ambooj

Subjects
Biomedical and Clinical Sciences, Clinical Sciences, Stroke, Clinical Research, Neurosciences, Good Health and Well Being, Brain Ischemia, COVID-19, Humans, Ischemic Stroke, Middle Aged, Retrospective Studies, SARS-CoV-2, Thrombectomy, Treatment Outcome, stroke, interventional, North American Neurovascular COVID-19 (NAN-C) Consortium & Society of Vascular and Interventional Neurology (SVIN) Investigators, Medical and Health Sciences, Psychology and Cognitive Sciences, Neurology & Neurosurgery, Clinical sciences
Abstract

BackgroundTo analyse the clinical characteristics of COVID-19 with acute ischaemic stroke (AIS) and identify factors predicting functional outcome.MethodsMulticentre retrospective cohort study of COVID-19 patients with AIS who presented to 30 stroke centres in the USA and Canada between 14 March and 30 August 2020. The primary endpoint was poor functional outcome, defined as a modified Rankin Scale (mRS) of 5 or 6 at discharge. Secondary endpoints include favourable outcome (mRS ≤2) and mortality at discharge, ordinal mRS (shift analysis), symptomatic intracranial haemorrhage (sICH) and occurrence of in-hospital complications.ResultsA total of 216 COVID-19 patients with AIS were included. 68.1% (147/216) were older than 60 years, while 31.9% (69/216) were younger. Median [IQR] National Institutes of Health Stroke Scale (NIHSS) at presentation was 12.5 (15.8), and 44.2% (87/197) presented with large vessel occlusion (LVO). Approximately 51.3% (98/191) of the patients had poor outcomes with an observed mortality rate of 39.1% (81/207). Age >60 years (aOR: 5.11, 95% CI 2.08 to 12.56, p

Published
2022

9. Pivotal trial of the Neuroform Atlas stent for treatment of posterior circulation aneurysms: one-year outcomes

Author

Jankowitz, Brian T, Jadhav, Ashutosh P, Gross, Bradley, Jovin, Tudor G, Alhajeri, Abdulnasser A, Fraser, Justin F, Hanel, Ricardo A, Sauvageau, Eric, Aghaebrahim, Amin, Frei, Donald, Bellon, Richard, Loy, David, Puri, Ajit S, Malek, Adel M, Thomas, Ajith, Toth, Gabor, Lopes, Demetrius Klee, Crowley, R Webster, Arthur, Adam S, Reavey-Cantwell, John, Lin, Eugene, Siddiqui, Adnan H, Alexander, Michael J, Khaldi, Ahmad, Colby, Geoffrey P, Caplan, Justin M, Satti, Sudhakar R, Turk, Aquilla S, Spiotta, Alejandro M, Klucznik, Richard, Hallam, Danial K, Kung, David, Froehler, Michael T, Callison, R Charles, Kan, Peter, Hetts, Steven W, and Zaidat, Osama O

Subjects
Biomedical and Clinical Sciences, Clinical Sciences, Bioengineering, Clinical Trials and Supportive Activities, Assistive Technology, Stroke, Neurosciences, Clinical Research, Aged, Cerebral Angiography, Embolization, Therapeutic, Female, Humans, Intracranial Aneurysm, Middle Aged, Prospective Studies, Retrospective Studies, Stents, Treatment Outcome, aneurysm, coil, stent, Clinical sciences
Abstract

BackgroundStent-assisted coiling of wide-necked intracranial aneurysms (IAs) using the Neuroform Atlas Stent System (Atlas) has shown promising results.ObjectiveTo present the primary efficacy and safety results of the ATLAS Investigational Device Exemption (IDE) trial in a cohort of patients with posterior circulation IAs.MethodsThe ATLAS trial is a prospective, multicenter, single-arm, open-label study of unruptured, wide-necked, IAs treated with the Atlas stent and adjunctive coiling. This study reports the results of patients with posterior circulation IAs. The primary efficacy endpoint was complete aneurysm occlusion (Raymond-Roy (RR) class I) on 12-month angiography, in the absence of re-treatment or parent artery stenosis >50%. The primary safety endpoint was any major ipsilateral stroke or neurological death within 12 months. Adjudication of the primary endpoints was performed by an imaging core laboratory and a Clinical Events Committee.ResultsThe ATLAS trial enrolled and treated 116 patients at 25 medical centers with unruptured, wide-necked, posterior circulation IAs (mean age 60.2±10.5 years, 81.0% (94/116) female). Stents were placed in all patients with 100% technical success rate. A total of 95/116 (81.9%) patients had complete angiographic follow-up at 12 months, of whom 81 (85.3%) had complete aneurysm occlusion (RR class I). The primary effectiveness outcome was achieved in 76.7% (95% CI 67.0% to 86.5%) of patients. Overall, major ipsilateral stroke and secondary persistent neurological deficit occurred in 4.3% (5/116) and 1.7% (2/116) of patients, respectively.ConclusionsIn the ATLAS IDE posterior circulation cohort, the Neuroform Atlas Stent System with adjunctive coiling demonstrated high rates of technical and safety performance. Trial registration number https://clinicaltrials.gov/ct2/show/NCT02340585.

Published
2022

10. Texture Analysis Using CT and Chemical Shift Encoding-Based Water-Fat MRI Can Improve Differentiation Between Patients With and Without Osteoporotic Vertebral Fractures

Author

Sollmann, Nico, Becherucci, Edoardo A, Boehm, Christof, Husseini, Malek El, Ruschke, Stefan, Burian, Egon, Kirschke, Jan S, Link, Thomas M, Subburaj, Karupppasamy, Karampinos, Dimitrios C, Krug, Roland, Baum, Thomas, and Dieckmeyer, Michael

Subjects
Biomedical and Clinical Sciences, Clinical Sciences, Biomedical Imaging, Osteoporosis, Rare Diseases, Musculoskeletal, Adult, Aged, Aged, 80 and over, Bone Density, Cancellous Bone, Female, Humans, Image Processing, Computer-Assisted, Lumbar Vertebrae, Magnetic Resonance Imaging, Male, Middle Aged, Osteoporotic Fractures, Spinal Fractures, Thoracic Vertebrae, Tomography, X-Ray Computed, bone mineral density, convolutional neural network, opportunistic imaging, osteoporosis, proton density fat fraction, texture analysis, vertebral fracture, Nutrition and Dietetics, Clinical sciences
Abstract

PurposeOsteoporosis is a highly prevalent skeletal disease that frequently entails vertebral fractures. Areal bone mineral density (BMD) derived from dual-energy X-ray absorptiometry (DXA) is the reference standard, but has well-known limitations. Texture analysis can provide surrogate markers of tissue microstructure based on computed tomography (CT) or magnetic resonance imaging (MRI) data of the spine, thus potentially improving fracture risk estimation beyond areal BMD. However, it is largely unknown whether MRI-derived texture analysis can predict volumetric BMD (vBMD), or whether a model incorporating texture analysis based on CT and MRI may be capable of differentiating between patients with and without osteoporotic vertebral fractures.Materials and methodsTwenty-six patients (15 females, median age: 73 years, 11 patients showing at least one osteoporotic vertebral fracture) who had CT and 3-Tesla chemical shift encoding-based water-fat MRI (CSE-MRI) available were analyzed. In total, 171 vertebral bodies of the thoracolumbar spine were segmented using an automatic convolutional neural network (CNN)-based framework, followed by extraction of integral and trabecular vBMD using CT data. For CSE-MRI, manual segmentation of vertebral bodies and consecutive extraction of the mean proton density fat fraction (PDFF) and T2* was performed. First-order, second-order, and higher-order texture features were derived from texture analysis using CT and CSE-MRI data. Stepwise multivariate linear regression models were computed using integral vBMD and fracture status as dependent variables.ResultsPatients with osteoporotic vertebral fractures showed significantly lower integral and trabecular vBMD when compared to patients without fractures (p

Published
2022

11. Norms and equivalences for MoCA-30, MoCA-22, and MMSE in the oldest-old

Author

Melikyan, Zarui A, Malek-Ahmadi, Michael, O’Connor, Kathleen, Atri, Alireza, Kawas, Claudia H, and Corrada, María M

Subjects
Biomedical and Clinical Sciences, Clinical Sciences, Clinical Research, Aging, Aged, 80 and over, Cognitive Dysfunction, Humans, Mass Screening, Mental Status and Dementia Tests, Neuropsychological Tests, Oldest-old, 90+, Score conversion, MMSE, MoCA-30, MoCA-22, 90 + , Public Health and Health Services, Cognitive Sciences, Geriatrics, Clinical sciences
Abstract

BackgroundCognitive screening is important for the oldest-old (age 90 +). This age group is the fastest growing and has the highest risk of dementia. However, norms and score equivalence for screening tests are lacking for this group.AimsTo provide norms and score equivalence for commonly used cognitive screening tests for the oldest-old.MethodsData on 157 participants of the Center for Healthy Aging Longevity Study aged 90 + were analyzed. First, we derived norms for (1) subtests and cognitive domains of the in-person Montreal Cognitive Assessment having a maximum score of 30 (MoCA-30) and (2) the total MoCA-22 score, obtained from the in-person MoCA-30 by summing the subtests that do not require visual input to a maximum score of 22. These norms were derived from 124 participants with a Mini-Mental State Examination (MMSE) ≥ 27. Second, we derived score equivalences for MMSE to MoCA-30 and MoCA-22, and MoCA-30 to MoCA-22 using equipercentile equating method with log-linear smoothing, based on all 157 participants.ResultsMoCA-22 total score norms are: mean = 18.3(standard deviation = 2.2). An MMSE score of 27 is equivalent to a MoCA-30 score of 22 and a MoCA-22 score of 16.Discussion and conclusionsSubtest, domain and MoCA-22 norms will aid in evaluation of the oldest-old who cannot complete the MoCA-30 or are tested over the phone. The equivalences of the three cognitive tests (MMSE, MoCA-30, MoCA-22) in the oldest-old will facilitate continuity of cognitive tracking of individuals tested with different tests over time and comparison of the studies that use different cognitive tests.

Published
2021

12. Conceptualization of utility in translational clinical genomics research

Author

Smith, Hadley Stevens, Brothers, Kyle B, Knight, Sara J, Ackerman, Sara L, Rini, Christine, Veenstra, David L, McGuire, Amy L, Wilfond, Benjamin S, and Malek, Janet

Subjects
Clinical Research, Genetics, Biotechnology, Health Services, Human Genome, Generic health relevance, Good Health and Well Being, Concept Formation, Genomics, Humans, Translational Research, Biomedical, Biological Sciences, Medical and Health Sciences, Genetics & Heredity
Abstract

Prior to integration into clinical care, a novel medical innovation is typically assessed in terms of its balance of benefits and risks, often referred to as utility. Members of multidisciplinary research teams may conceptualize and assess utility in different ways, which has implications within the translational genomics community and for the evidence base upon which clinical guidelines groups and healthcare payers make decisions. Ambiguity in the conceptualization of utility in translational genomics research can lead to communication challenges within research teams and to study designs that do not meet stakeholder needs. We seek to address the ambiguity challenge by describing the conceptual understanding of utility and use of the term by scholars in the fields of philosophy, medicine, and the social sciences of decision psychology and health economics. We illustrate applications of each field's orientation to translational genomics research by using examples from the Clinical Sequencing Evidence-Generating Research (CSER) consortium, and we provide recommendations for increasing clarity and cohesion in future research. Given that different understandings of utility will align to a greater or lesser degree with important stakeholders' views, more precise use of the term can help researchers to better integrate multidisciplinary investigations and communicate with stakeholders.

Published
2021

13. Health- and Vision-Related Quality of Life in a Randomized Controlled Trial Comparing Methotrexate and Mycophenolate Mofetil for Uveitis

Author

Kelly, Nicole K, Chattopadhyay, Aheli, Rathinam, SR, Gonzales, John A, Thundikandy, Radhika, Kanakath, Anuradha, Murugan, S Bala, Vedhanayaki, R, Cugley, Dean, Lim, Lyndell L, Suhler, Eric B, Al-Dhibi, Hassan A, Ebert, Caleb D, Berlinberg, Elyse J, Porco, Travis C, Acharya, Nisha R, Subramanian, AL Sivarama, Jeyakohila, G, Evangelin, Gracy, Azhagupandi, AM, Praba, CV, Bharati, S, Gomathi, S, Nirmaladevi, NJ, Siddiq, Mohammed, Vijayakumar, B, Devi, SR, Saravanan, VR, Babu, Upendra, Srija, R, Dhanalakshmi, S, Sakthimari, RR, Keerthana, PS, Mallika, AM, Vasanthi, C, Mariselvi, PB, Pandeeswari, P, Sudarvanitha, SM, Prema, R, Baskaran, Prabu, Madanagopalan, S, Nagesha, Chokkahalli K, Thilagavathi, R, Krishnakumari, Chitra, P, Irudhaya Raj, Saravanan, S, Mary, Grace, Nagarasi, S, Gnansi, Kiruba, Arellanes-Garcia, Lourdes, del Rio, Luz Elena Concha, Kalb, Rashel Cheja, Fernández, Nancy, Burgoa, Yoko, Hernández, Hilda, Cuello, Roberto Fabela, Garcia, Lorenzo Agustín Martínez, Rodríguez, Ricardo Montoya, del Carmen Preciado, Maria, Arreola, Andrea, Stone, Donald, Al-Shamrani, Mohammed, Al-Nuwaysir, Sara, Al-Hommadi, Abdulrahman, Al-Omran, Abdullah, Al-Nasser, Saleh, Al-Zahrani, Gahram, Mashan, Eman, Al-Ghamdi, Mizher, Al-Tuwejri, Ayshah, Goldstein, Debra A, Castro-Malek, Anna Liza, Dela Rosa, Gemma, Skelly, Marriner, Suhler, Eric, Rosenbaum, James, Lin, Phoebe, Salek, Sherveen, Biggee, Kristin, Shifera, Amde, Kopplin, Laura, Mount, George, Giles, Tracy, Nolte, Susan, Lundquist, Ann, Liesegang, Teresa, Romo, Albert, Howell, Chris, Pickell, Scott, Steinkemp, Peter, Ryan, Dawn, Barth, Jordan, Hui, Jocelyn, and Ukachukwu, Chiedozie

Subjects
Biomedical and Clinical Sciences, Ophthalmology and Optometry, Clinical Research, Eye Disease and Disorders of Vision, Clinical Trials and Supportive Activities, 6.1 Pharmaceuticals, Evaluation of treatments and therapeutic interventions, Good Health and Well Being, Administration, Oral, Adult, Aged, Enzyme Inhibitors, Female, Health, Health Status, Humans, Immunosuppressive Agents, Male, Methotrexate, Middle Aged, Mycophenolic Acid, Prospective Studies, Quality of Life, Sickness Impact Profile, Surveys and Questionnaires, Uveitis, Vision, Ocular, Antimetabolites, uveitis, Quality of life, FAST Research Group, Clinical Sciences, Opthalmology and Optometry, Public Health and Health Services, Ophthalmology & Optometry, Ophthalmology and optometry
Abstract

PurposeTo evaluate changes in health-related and vision-related quality of life (VRQoL) among patients with noninfectious uveitis who were treated with antimetabolites.DesignSecondary analysis of a randomized controlled trial.ParticipantsPatients with noninfectious uveitis from India, the United States, Australia, Saudi Arabia, and Mexico.MethodsFrom 2013 through 2017, 216 participants were randomized to receive 25 mg weekly oral methotrexate or 1.5 g twice daily oral mycophenolate mofetil. Median changes in quality of life (QoL) were measured using Wilcoxon signed-rank tests, and differences between treatment groups were measured using linear mixed models, adjusting for baseline QoL score, age, gender, and site. Among Indian patients, VRQoL scores from a general scale (the National Eye Institute Visual Function Questionnaire [NEI-VFQ]) and a culturally specific scale (the Indian Visual Function Questionnaire [IND-VFQ]) were compared using Pearson correlation tests.Main outcome measuresVision-related QoL (NEI-VFQ and IND-VFQ) and health-related QoL (HRQoL; physical component score [PCS] and mental component score [MCS] of the Medical Outcomes Study 36-Item Short Form Survey [SF-36v2]) were measured at baseline, the primary end point (6 months or treatment failure before 6 months), and the secondary end point (12 months or treatment failure between 6 and 12 months).ResultsAmong 193 participants who reached the primary end point, VRQoL increased from baseline by a median of 12.0 points (interquartile range [IQR], 1.0-26.1, NEI-VFQ scale), physical HRQoL increased by a median of 3.6 points (IQR, -1.4 to 14.9, PCS SF-36v2), and mental HRQoL increased by a median of 3.0 points (IQR, -3.7 to 11.9, MCS SF-36v2). These improvements in NEI-VFQ, SF-36v2 PCS, and SF-36v2 MCS scores all were significant (P < 0.01). The linear mixed models showed that QoL did not differ between treatment groups for each QoL assessment (NEI-VFQ, IND-VFQ, PCS SF-36v2, and MCS SF-36v2; P > 0.05 for all). The NEI-VFQ and IND-VFQ scores for Indian participants were correlated highly at baseline and the primary and secondary end points (correlation coefficients, 0.87, 0.80, and 0.90, respectively).ConclusionsAmong patients treated with methotrexate or mycophenolate mofetil for uveitis, VRQoL and HRQoL improved significantly over the course of 1 year and did not differ by treatment allocation. These findings suggest that antimetabolites could improve overall patient well-being and daily functioning.

Published
2021

14. Age and Acute Ischemic Stroke Outcome in North American Patients With COVID‐19

Author

Dmytriw, Adam A, Dibas, Mahmoud, Schirmer, Clemens M, Settecase, Fabio, Heran, Manraj KS, Efendizade, Aslan, Kühn, Anna Luisa, Puri, Ajit S, Ospel, Johanna, Menon, Bijoy, Sivakumar, Sanjeev, Mowla, Ashkan, Vela‐Duarte, Daniel, Linfante, Italo, Dabus, Guilherme, Regenhardt, Robert W, Patel, Aman B, Leslie‐Mazwi, Thabele, D’Amato, Salvatore, Rosenthal, Joseph, Zha, Alicia, Talukder, Nafee, Sheth, Sunil, Cooke, Daniel, Leung, Lester Y, Malek, Adel, Voetsch, Barbara, Sehgal, Siddharth, Wakhloo, Ajay K, Wu, Hannah, Cohen, Jake, Turkel‐Parella, David, Xavier, Andrew, Tiwari, Ambooj, and Consortium, the North American Neurovascular COVID‐19

Subjects
Clinical Research, Brain Disorders, Stroke, Rehabilitation, Good Health and Well Being, Adult, Age Factors, Aged, Aged, 80 and over, COVID-19, Canada, Female, Humans, Ischemic Stroke, Male, Middle Aged, Prospective Studies, United States, acute ischemic stroke, age outcomes, COVID-19 pandemic, SARS-CoV-2, North American Neurovascular COVID‐19 (NAN‐C) Consortium, COVID‐19 pandemic, SARS‐CoV‐2, Cardiorespiratory Medicine and Haematology
Abstract

Background Acute ischemic stroke (AIS) in the context of COVID-19 has received considerable attention for its propensity to affect patients of all ages. We aimed to evaluate the effect of age on functional outcome and mortality following an acute ischemic event. Methods and Results A prospectively maintained database from comprehensive stroke centers in Canada and the United States was analyzed for patients with AIS from March 14 to September 30, 2020 who tested positive for SARS-CoV-2. The primary outcome was Modified Rankin Scale score at discharge, and the secondary outcome was mortality. Baseline characteristics, laboratory values, imaging, and thrombectomy workflow process times were assessed. Among all 126 patients with COVID-19 who were diagnosed with AIS, the median age was 63 years (range, 27-94). There were 35 (27.8%) patients with AIS in the aged ≤55 years group, 47 (37.3%) in the aged 56 to 70 group, and 44 (34.9%) in the aged >70 group. Intravenous tissue plasminogen activator and thrombectomy rates were comparable across these groups, (P=0.331 and 0.212, respectively). There was a significantly lower rate of mortality between each group favoring younger age (21.9% versus 45.0% versus 48.8%, P=0.047). After multivariable adjustment for possible confounders, a 1-year increase in age was significantly associated with fewer instances of a favorable outcome of Modified Rankin Scale 0 to 2 (odds ratio [OR], 0.95; 95 CI%, 0.90-0.99; P=0.048) and higher mortality (OR, 1.06; 95 CI%, 1.02-1.10; P=0.007). Conclusions AIS in the context of COVID-19 affects young patients at much greater rates than pre-pandemic controls. Nevertheless, instances of poor functional outcome and mortality are closely tied to increasing age.

Published
2021

15. Genetics of HLA Peptide Presentation and Impact on Outcomes in HLA-Matched Allogeneic Hematopoietic Cell Transplantation

Author

Story, Charlotte McIlwaine, Wang, Tao, Bhatt, Vijaya Raj, Battiwalla, Minoo, Badawy, Sherif M, Kamoun, Malek, Gragert, Loren, Brown, Valerie, Baxter-Lowe, Lee Ann, Marsh, Steven GE, Gadalla, Shahinaz M, Schetelig, Johannes, Mytilineos, Joannis, Miklos, David, Waller, Edmund K, Kuxhausen, Michelle, Spellman, Stephen, Lee, Stephanie, Paczesny, Sophie, Lansford, Jefferson L, Vincent, Benjamin G, Riches, Marcie L, Armistead, Paul M, and Committee, Center for International Blood and Marrow Transplant Research Immunobiology Working

Subjects
Biomedical and Clinical Sciences, Cardiovascular Medicine and Haematology, Immunology, Prevention, Transplantation, Clinical Research, Good Health and Well Being, Hematopoietic Stem Cell Transplantation, Humans, Neoplasm Recurrence, Local, Peptides, Retrospective Studies, Unrelated Donors, Center for International Blood and Marrow Transplant Research Immunobiology Working Committee, Graft-versus-host disease, HLA, Minor histocompatibility antigen, Peptide epitope binding, Clinical Sciences, Cardiovascular medicine and haematology
Abstract

Minor histocompatibility antigens (mHAs), recipient-derived peptide epitopes presented on the cell surface, are known to mediate graft-versus-host disease (GVHD); however, there are no current methods to associate mHA features with GVHD risk. This deficiency is due in part to the lack of technological means to accurately predict, let alone confirm, the tremendous number of potential mHAs in each individual transplant. Previous studies have shown that different HLA molecules present varying fractions of candidate peptide epitopes; however, the genetic "distance" between HLA-matched donors and recipients is relatively constrained. From these 2 observations, it is possible that the HLA type for a donor-recipient pair (DRP) would provide a surrogate measurement of the number of predicted mHAs, which could be related to GVHD risk. Because different HLA molecules present variable numbers of peptide antigens, a predicted cumulative peptide-binding efficiency can be calculated for individual DRP based on the pair's HLA type. The purpose of this study was to test whether cumulative peptide-binding efficiency is associated with the risk of acute GVHD (aGVHD) or relapse. In this retrospective Center for International Blood and Marrow Transplant Research study, a total of 3242 HLA-matched DRPs were analyzed for predicted cumulative peptide-binding efficiency using their HLA types and were divided into tertiles based on their scores. Univariable and multivariable analyses was performed to test for associations between cumulative peptide-binding efficiency for DRPs, divided into the HLA-matched related donor (MRD) and HLA-matched unrelated donor (MUD) cohorts, and the primary outcomes of aGVHD and relapse. Secondary outcomes investigated included overall survival, disease-free survival, and transplantation-related mortality. Using a computationally generated peptidome as a test dataset, the tested series of HLA class I displayed peptide-binding frequencies ranging from 0.1% to 3.8% of the full peptidome, and HLA class II molecules had peptide-binding frequencies of 12% to 77% across the HLA-DRB1 allotypes. By increasing binding efficiency tertile, the cumulative incidence of aGVHD at 6 months for MUD patients was 41%, 41%, and 45% for HLA class I (P = .336) and 44%, 41%, and 42% for HLA class II (P = .452). The cumulative incidences of relapse at 3 years for MUD transplant recipients were 36%, 38%, and 38% for HLA class I (P = .533) and 37%, 37%, and 38% for HLA class II (P = .896). The findings were similar for MRD transplant recipients. Multivariable analysis did not identify any impact of peptide-binding efficiency on aGVHD or relapse in MUD or MRD transplant recipients. Whereas GVHD is mediated by minor antigen mismatches in the context of HLA-matched allo-HCT, peptide-binding efficiency, which was used as a surrogate measurement for predicted number of binding antigens, did not provide additional clinical information for GVHD risk assessment. The negative result may be due to the limitations of this surrogate marker, or it is possible that GVHD is driven by a subset of immunogenic mHAs. Further research should be directed at direct mHA epitope and immunogenicity prediction.

Published
2021

16. New Class of Radially Adjustable Stentrievers for Acute Ischemic Stroke: Primary Results of the Multicenter TIGER Trial.

Author

Gupta, Rishi, Saver, Jeffrey L, Levy, Elad, Zaidat, Osama O, Yavagal, Dileep, Liebeskind, David S, Khaldi, Ahmad, Gross, Bradley, Lang, Michael, Narayanan, Sandra, Jankowitz, Brian, Snyder, Kenneth, Siddiqui, Adnan, Davies, Jason, Lin, Eugene, Hassan, Ameer, Hanel, Ricardo, Aghaebrahim, Amin, Kaushal, Ritesh, Malek, Ali, Mueller-Kronast, Nils, Starke, Robert, Bozorgchami, Hormozd, Nesbit, Gary, Horikawa, Masahiro, Priest, Ryan, Liu, Jesse, Budzik, Ronald F, Pema, Peter, Vora, Nirav, Taqi, M Asif, Samaniego, Edgar, Wang, Qingliang Tony, Nossek, Erez, Dabus, Guilherme, Linfante, Italo, Puri, Ajit, Abergel, Eitan, Starkman, Sidney, Tateshima, Satoshi, Jadhav, Ashutosh P, and TIGER Trial Investigators

Subjects
TIGER Trial Investigators, Humans, Thrombectomy, Aged, Middle Aged, Female, Male, Endovascular Procedures, Ischemic Stroke, goal, intracranial hemorrhage, laboratories, reperfusion, stent, Cardiorespiratory Medicine and Haematology, Clinical Sciences, Neurosciences, Neurology & Neurosurgery
Abstract

[Figure: see text].

Published
2021

17. RAS-targeted therapies: is the undruggable drugged?

Author

Moore, Amanda R, Rosenberg, Scott C, McCormick, Frank, and Malek, Shiva

Subjects
Biomedical and Clinical Sciences, Oncology and Carcinogenesis, Immunology, Rare Diseases, Genetics, Lung Cancer, Biotechnology, Lung, Orphan Drug, Cancer, Development of treatments and therapeutic interventions, 5.1 Pharmaceuticals, Animals, Antineoplastic Agents, Drug Delivery Systems, Humans, Mutation, Neoplasms, ras Proteins, Biological Sciences, Medical and Health Sciences, Pharmacology & Pharmacy, Biological sciences, Biomedical and clinical sciences, Health sciences
Abstract

RAS (KRAS, NRAS and HRAS) is the most frequently mutated gene family in cancers, and, consequently, investigators have sought an effective RAS inhibitor for more than three decades. Even 10 years ago, RAS inhibitors were so elusive that RAS was termed 'undruggable'. Now, with the success of allele-specific covalent inhibitors against the most frequently mutated version of RAS in non-small-cell lung cancer, KRASG12C, we have the opportunity to evaluate the best therapeutic strategies to treat RAS-driven cancers. Mutation-specific biochemical properties, as well as the tissue of origin, are likely to affect the effectiveness of such treatments. Currently, direct inhibition of mutant RAS through allele-specific inhibitors provides the best therapeutic approach. Therapies that target RAS-activating pathways or RAS effector pathways could be combined with these direct RAS inhibitors, immune checkpoint inhibitors or T cell-targeting approaches to treat RAS-mutant tumours. Here we review recent advances in therapies that target mutant RAS proteins and discuss the future challenges of these therapies, including combination strategies.

Published
2020

18. Pivotal Trial of the Neuroform Atlas Stent for Treatment of Anterior Circulation Aneurysms

Author

Zaidat, Osama O, Hanel, Ricardo A, Sauvageau, Eric A, Aghaebrahim, Amin, Lin, Eugene, Jadhav, Ashutosh P, Jovin, Tudor G, Khaldi, Ahmad, Gupta, Rishi G, Johnson, Andrew, Frei, Donald, Loy, David, Malek, Adel, Toth, Gabor, Siddiqui, Adnan, Reavey-Cantwell, John, Thomas, Ajith, Hetts, Steven W, Jankowitz, Brian T, Gross, Bradley, Ducruet, Andrew, Panczkowski, David, Shoirah, Hazem, Al-Bayati, Alhamza, Weiner, Greg, Kenmuir, Cynthia, Tadi, Prasanna, Walker, Gregory, Johnson, K, Frei, Don, Bellon, Richard, Atchie, Benjamin, Kaminsky, Ian, Huddle, Dan, Bain, Mark, Rasmussen, Peter, Hussain, M Shazam, Moore, Nina, Masaryk, Thomas, Elgabaly, Mohamed, Cerejo, Russell, Hardman, Julian, John, Seby, Bauer, Andrew, Peih-Chir Tsai, Jenny, Levy, Elad, Snyder, Kenneth, Davies, Jason, Ogilvy, Christopher, Rivet, Dennis, Alexander, Michael, Moser, Franklin, Maya, Marcel, Schiraldi, Michael, Eboli, Paula, Caplan, Justin, Jiang, Bowen, Bender, Matthew, Colby, Geoffrey, Satti, Sudhakar, Sivapatham, Thinesh, Kung, David, Pukenas, Bryan, Hurst, Robert, Smith, Michelle J, Puri, Ajit, Massari, Francesco, Rex, David, Fraser, Justin, Grupke, Stephen, Alhajeri, Abdulnasser, Klucznik, Richard, Diaz, Orlando, Britz, Gavin, Zhan, Yi, Spiotta, Alejandro, Lena, Jonathan, Turk, Aquilla, Chaudry, Mohamad, Fargen, Kyle, Turner, Raymond, Kan, Peter, Duckworth, Edward, Asif Taqi, Muhammad, Hou, Samuel, Arthur, Adam S, Elijovich, Lucas, Hoit, Daniel, Nickele, Christopher, Vachhani, Jay, Thomas Doss, Vinodh, Crowley, Richard, Lopes, Demetrius, Chen, Michael, Hallam, Danial, Ghodke, Basavaraj, Kim, Louis, Callison, Richard, Alshekhlee, Amer, and Kale, Sushant

Subjects
Bioengineering, Stroke, Assistive Technology, Neurosciences, Clinical Research, Clinical Trials and Supportive Activities, Brain Disorders, Adult, Aged, Embolization, Therapeutic, Endovascular Procedures, Female, Humans, Intracranial Aneurysm, Male, Middle Aged, Stents, Treatment Outcome, angiography, intracranial aneurysm, middle cerebral artery, retreatment, stent, ATLAS Investigators, Cardiorespiratory Medicine and Haematology, Clinical Sciences, Neurology & Neurosurgery
Abstract

Background and purposeStent-assisted coil embolization using the new generation Neuroform Atlas Stent System has shown promising safety and efficacy. The primary study results of the anterior circulation aneurysm cohort of the treatment of wide-neck, saccular, intracranial, aneurysms with the Neuroform Atlas Stent System (ATLAS trial [Safety and Effectiveness of the Treatment of Wide Neck, Saccular Intracranial Aneurysms With the Neuroform Atlas Stent System]) are presented.MethodsATLAS IDE trial (Investigational Device Exemption) is a prospective, multicenter, single-arm, open-label study of wide-neck (neck ≥4 mm or dome-to-neck ratio 50%) at the target location. The primary safety end point was any major stroke or ipsilateral stroke or neurological death within 12 months. Adjudication of the primary end points was performed by an independent Imaging Core Laboratory and the Clinical Events Committee.ResultsA total of 182 patients with wide-neck anterior circulation aneurysms at 25 US centers were enrolled. The mean age was 60.3±11.4 years, 73.1% (133/182) women, and 80.8% (147/182) white. Mean aneurysm size was 6.1±2.2 mm, mean neck width was 4.1±1.2 mm, and mean dome-to-neck ratio was 1.2±0.3. The most frequent aneurysm locations were the anterior communicating artery (64/182, 35.2%), internal carotid artery ophthalmic artery segment (29/182, 15.9%), and middle cerebral artery bifurcation (27/182, 14.8%). Stents were placed in the anticipated anatomic location in all patients. The study met both primary safety and efficacy end points. The composite primary efficacy end point of complete aneurysm occlusion (Raymond-Roy 1) without parent artery stenosis or aneurysm retreatment was achieved in 84.7% (95% CI, 78.6%-90.9%) of patients. Overall, 4.4% (8/182, 95% CI, 1.9%-8.5%) of patients experienced a primary safety end point of major ipsilateral stroke or neurological death.ConclusionsIn the ATLAS IDE anterior circulation aneurysm cohort premarket approval study, the Neuroform Atlas stent with adjunctive coiling met the primary end points and demonstrated high rates of long-term complete aneurysm occlusion at 12 months, with 100% technical success and

Published
2020

19. Pomalidomide plus low‐dose dexamethasone in relapsed refractory multiple myeloma after lenalidomide treatment failure

Author

Siegel, David S, Schiller, Gary J, Song, Kevin W, Agajanian, Richy, Stockerl‐Goldstein, Keith, Kaya, Hakan, Sebag, Michael, Samaras, Christy, Malek, Ehsan, Talamo, Giampaolo, Seet, Christopher S, Mouro, Jorge, Pierceall, William E, Zafar, Faiza, Chung, Weiyuan, Srinivasan, Shankar, Agarwal, Amit, and Bahlis, Nizar J

Subjects
Biomedical and Clinical Sciences, Cardiovascular Medicine and Haematology, Oncology and Carcinogenesis, Clinical Trials and Supportive Activities, Cancer, Hematology, Rare Diseases, Clinical Research, Evaluation of treatments and therapeutic interventions, 6.1 Pharmaceuticals, Adult, Aged, Aged, 80 and over, Antineoplastic Combined Chemotherapy Protocols, Dexamethasone, Disease-Free Survival, Female, Humans, Lenalidomide, Male, Middle Aged, Multiple Myeloma, Survival Rate, Thalidomide, pomalidomide, dexamethasone, lenalidomide, multiple myeloma, refractory, Cardiorespiratory Medicine and Haematology, Immunology, Cardiovascular medicine and haematology
Abstract

Patients with relapsed/refractory multiple myeloma (RRMM) for whom the benefits of lenalidomide have been exhausted in early treatment lines need effective therapies. In cohort A of the phase 2 MM-014 trial, we examined the safety and efficacy of pomalidomide plus low-dose dexamethasone immediately after lenalidomide-based treatment failure in patients with RRMM and two prior lines of therapy. Pomalidomide 4 mg was given on days 1 to 21 of 28-day cycles. Dexamethasone 40 mg (20 mg for patients aged >75 years) was given on days 1, 8, 15 and 22 of 28-day cycles. The primary endpoint was overall response rate (ORR), and secondary endpoints included progression-free survival (PFS), overall survival (OS) and safety. The intention-to-treat population comprised 56 patients; all received prior lenalidomide (87·5% lenalidomide refractory) and 39 (69·6%) received prior bortezomib. ORR was 32·1% (28·2% in the prior-bortezomib subgroup). Median PFS was 12·2 months (7·9 months in the prior-bortezomib subgroup). Median OS was 41·7 months (38·6 months in the prior-bortezomib subgroup). The most common grade 3/4 treatment-emergent adverse events were anaemia (25·0%), pneumonia (14·3%) and fatigue (14·3%). These findings support earlier sequencing of pomalidomide-based therapy in lenalidomide-pretreated patients with RRMM, including those who have become refractory to lenalidomide. Trial registration: www.ClinicalTrials.gov identifier NCT01946477.

Published
2020

20. LXRs regulate features of age-related macular degeneration and may be a potential therapeutic target.

Author

Choudhary, Mayur, Ismail, Ebraheim N, Yao, Pei-Li, Tayyari, Faryan, Radu, Roxana A, Nusinowitz, Steven, Boulton, Michael E, Apte, Rajendra S, Ruberti, Jeffrey W, Handa, James T, Tontonoz, Peter, and Malek, Goldis

Subjects
Retina, Endothelial Cells, Animals, Mice, Inbred C57BL, Mice, Knockout, Humans, Mice, Macular Degeneration, Disease Models, Animal, Inflammation, Aging, Phenotype, Adolescent, Adult, Aged, Aged, 80 and over, Middle Aged, Female, Male, Genome-Wide Association Study, Retinal Pigment Epithelium, Young Adult, Transcriptome, Liver X Receptors, Mouse models, Ophthalmology, Retinopathy, Therapeutics, Neurodegenerative, Eye Disease and Disorders of Vision, Digestive Diseases, Neurosciences, Aetiology, 2.1 Biological and endogenous factors, Eye
Abstract

Effective treatments and animal models for the most prevalent neurodegenerative form of blindness in elderly people, called age-related macular degeneration (AMD), are lacking. Genome-wide association studies have identified lipid metabolism and inflammation as AMD-associated pathogenic pathways. Given liver X receptors (LXRs), encoded by the nuclear receptor subfamily 1 group H members 2 and 3 (NR1H3 and NR1H2), are master regulators of these pathways, herein we investigated the role of LXR in human and mouse eyes as a function of age and disease and tested the therapeutic potential of targeting LXR. We identified immunopositive LXR fragments in human extracellular early dry AMD lesions and a decrease in LXR expression within the retinal pigment epithelium (RPE) as a function of age. Aged mice lacking LXR presented with isoform-dependent ocular pathologies. Specifically, loss of the Nr1h3 isoform resulted in pathobiologies aligned with AMD, supported by compromised visual function, accumulation of native and oxidized lipids in the outer retina, and upregulation of ocular inflammatory cytokines, while absence of Nr1h2 was associated with ocular lipoidal degeneration. LXR activation not only ameliorated lipid accumulation and oxidant-induced injury in RPE cells but also decreased ocular inflammatory markers and lipid deposition in a mouse model, thereby providing translational support for pursuing LXR-active pharmaceuticals as potential therapies for dry AMD.

Published
2020

21. Prospective study on embolization of intracranial aneurysms with the pipeline device: the PREMIER study 1 year results

Author

Hanel, Ricardo A, Kallmes, David F, Lopes, Demetrius Klee, Nelson, Peter Kim, Siddiqui, Adnan, Jabbour, Pascal, Pereira, Vitor M, Szikora István, Istvan, Zaidat, Osama O, Bettegowda, Chetan, Colby, Geoffrey P, Mokin, Maxim, Schirmer, Clemens, Hellinger, Frank R, Given Ii, Curtis, Krings, Timo, Taussky, Philipp, Toth, Gabor, Fraser, Justin F, Chen, Michael, Priest, Ryan, Kan, Peter, Fiorella, David, Frei, Don, Aagaard-Kienitz, Beverly, Diaz, Orlando, Malek, Adel M, Cawley, C Michael, and Puri, Ajit S

Subjects
Hematology, Neurosciences, Clinical Research, Clinical Trials and Supportive Activities, Stroke, Cardiovascular, Adult, Aged, Blood Vessel Prosthesis, Embolization, Therapeutic, Female, Follow-Up Studies, Humans, Intracranial Aneurysm, Male, Middle Aged, Prospective Studies, Retreatment, Self Expandable Metallic Stents, Treatment Outcome, aneurysm, flow diverter, artery, brain, intervention
Abstract

BackgroundPreliminary clinical studies on the safety and efficacy of the pipeline embolization device (PED) for the treatment of small/medium aneurysms have demonstrated high occlusion rates with low complications.ObjectiveTo evaluate the safety and effectiveness of the PED for treatment of wide necked small and medium intracranial aneurysms.MethodsPREMIER is a prospective, multicenter, single arm trial. Patients were treated with the PED for unruptured wide necked aneurysms, measuring ≤12 mm along the internal carotid artery or vertebral artery, between July 2014 and November 2015. At 1 year post-procedure, the primary effectiveness endpoint was complete occlusion (Raymond grade 1) without major parent vessel stenosis (≤50%) or retreatment, and the primary safety endpoint was major stroke in the territory supplied by the treated artery or neurologic death.ResultsA total of 141 patients were treated with PEDs (mean age 54.6±11.3 years, 87.9% (124/141) women). Mean aneurysm size was 5.0±1.92 mm, and 84.4% (119/141) measured

Published
2020

22. Neuroform Atlas Stent System for the treatment of intracranial aneurysm: primary results of the Atlas Humanitarian Device Exemption cohort.

Author

Jankowitz, Brian T, Hanel, Ricardo, Jadhav, Ashutosh P, Loy, David N, Frei, Donald, Siddiqui, Adnan H, Puri, Ajit S, Khaldi, Ahmad, Turk, Aquilla S, Malek, Adel M, Sauvageau, Eric, Hetts, Steven W, and Zaidat, Osama O

Subjects
Humans, Intracranial Aneurysm, Cerebral Angiography, Treatment Outcome, Embolization, Therapeutic, Patient Discharge, Retreatment, Cohort Studies, Prospective Studies, Blood Vessel Prosthesis, Adult, Aged, Middle Aged, Female, Male, Compassionate Use Trials, Self Expandable Metallic Stents, ATLAS, atlas stent, cerebral aneurysm, neuroform, stent-assisted coiling, wide-neck aneurysm, Embolization, Therapeutic
Abstract

Background and objectiveStent-assisted coil embolization is a well-established treatment of intracranial wide-necked aneurysms. The Neuroform Atlas Stent System is a new generation microstent designed to enhance coil support, conformability, deliverability, and improve deployment accuracy. We present the 1-year efficacy and angiographic results of the Humanitarian Device Exemption (HDE) cohort from the Atlas Investigational Device Exemption (IDE) clinical trial.MethodThe Atlas IDE trial is a prospective, multicenter, single-arm, open-label study of unruptured wide-necked intracranial aneurysms treated with the Neuroform Atlas stent and approved coils. The primary efficacy endpoint was the rate of 12-month complete aneurysm angiographic occlusion (Raymond class I) without target aneurysm retreatment or significant parent artery stenosis (>50%) at the target location. The primary safety endpoint was the rate of major ipsilateral stroke or neurological death within 12 months. Imaging core laboratory and Clinical EventsCommittee adjudicated the primary endpoints.Results30 patients were enrolled at eight US centers, with 27 patients completing the 12-month angiographic follow-up. The mean age was 59.4±11.8 years and 24/30 patients (80%) were women. The mean aneurysm size was 5.3±1.7 mm and the dome:neck ratio was 1.1±0.2. Procedural technical success of Neuroform Atlas Stent deployment was 100%. 27 patients completed 12-month angiographic follow-up and 30 patients completed their 6-month follow-up. When applying the last observation carried forward method, the primary efficacy endpoint was observed in 26/30 patients (86.7%, 95% CI 69.3% to 96.2%) compared with 25/27 patients (92.6%, 95% CI 75.7% to 99.1%) who completed the 12-month angiographic follow-up. The primary safety endpoint of stroke occurred in one patient (3.3%), who made a complete clinical recovery at discharge. There were no neurological deaths.ConclusionThe Neuroform Atlas stent in conjunction with coils demonstrated a high rate of complete aneurysm occlusion at 12-month angiographic follow-up, with an improved safety profile in the HDE cohort.Clinical trialgov registration numberNCT0234058;Results.

Published
2019

23. Influenza vaccination and myocarditis among patients receiving immune checkpoint inhibitors.

Author

Awadalla, Magid, Golden, Doll, Mahmood, Syed, Alvi, Raza, Mercaldo, Nathaniel, Hassan, Malek, Banerji, Dahlia, Rokicki, Adam, Mulligan, Connor, Murphy, Sean, Jones-OConnor, Maeve, Cohen, Justine, Heinzerling, Lucie, Armanious, Merna, Sullivan, Ryan, Damrongwatanasuk, Rongras, Chen, Carol, Gupta, Dipti, Kirchberger, Michael, Moslehi, Javid, Shah, Sachin, Ganatra, Sarju, Thavendiranathan, Paaladinesh, Rizvi, Muhammad, Sahni, Gagan, Lyon, Alexander, Tocchetti, Carlo, Mercurio, Valentina, Thuny, Franck, Ederhy, Stephane, Mahmoudi, Michael, Lawrence, Donald, Groarke, John, Nohria, Anju, Fradley, Michael, Reynolds, Kerry, and Neilan, Tomas

Subjects
Cancer, Cardiovascular disease, Immune checkpoint inhibitors, Immune-related adverse events, Influenza vaccination, Major adverse cardiac events, Myocarditis, Aged, Aged, 80 and over, Antineoplastic Agents, Immunological, Female, Humans, Influenza Vaccines, Influenza, Human, Male, Middle Aged, Myocarditis, Neoplasms, Registries, Vaccination
Abstract

BACKGROUND: Influenza vaccination (FV) is recommended for patients with cancer. Recent data suggested that the administration of the FV was associated with an increase in immune-related adverse events (irAEs) among patients on immune checkpoint inhibitors (ICIs). Myocarditis is an uncommon but serious complication of ICIs and may also result from infection with influenza. There are no data testing the relationship between FV and the development of myocarditis on ICIs. METHODS: Patients on ICIs who developed myocarditis (n = 101) (cases) were compared to ICI-treated patients (n = 201) without myocarditis (controls). A patient was defined as having the FV if they were administered the FV from 6 months prior to start of ICI to anytime during ICI therapy. Alternate thresholds for FV status were also tested. The primary comparison of interest was the rate of FV between cases and controls. Patients with myocarditis were followed for major adverse cardiac events (MACE), defined as the composite of cardiogenic shock, cardiac arrest, hemodynamically significant complete heart block and cardiovascular death. RESULTS: The FV was administered to 25% of the myocarditis cases compared to 40% of the non-myocarditis ICI-treated controls (p = 0.01). Similar findings of lower rates of FV administration were noted among myocarditis cases when alternate thresholds were tested. Among the myocarditis cases, those who were vaccinated had 3-fold lower troponin levels when compared to unvaccinated cases (FV vs. No FV: 0.12 [0.02, 0.47] vs. 0.40 [0.11, 1.26] ng/ml, p = 0.02). Within myocarditis cases, those administered the FV also had a lower rate of other irAEs when compared to unvaccinated cases (36 vs. 55% p = 0.10) including lower rates of pneumonitis (12 vs. 36%, p = 0.03). During follow-up (175 [IQR 89, 363] days), 47% of myocarditis cases experienced a MACE. Myocarditis cases who received the FV were at a lower risk of cumulative MACE when compared to unvaccinated cases (24 vs. 59%, p = 0.002). CONCLUSION: The rate of FV among ICI-related myocarditis cases was lower than controls on ICIs who did not develop myocarditis. In those who developed myocarditis related to an ICI, there was less myocardial injury and a lower risk of MACE among those who were administered the FV.

Published
2019

24. Chemoprevention agents for melanoma: A path forward into phase 3 clinical trials

Author

Jeter, Joanne M, Bowles, Tawnya L, Curiel-Lewandrowski, Clara, Swetter, Susan M, Filipp, Fabian V, Abdel-Malek, Zalfa A, Geskin, Larisa J, Brewer, Jerry D, Arbiser, Jack L, Gershenwald, Jeffrey E, Chu, Emily Y, Kirkwood, John M, Box, Neil F, Funchain, Pauline, Fisher, David E, Kendra, Kari L, Marghoob, Ashfaq A, Chen, Suephy C, Ming, Michael E, Albertini, Mark R, Vetto, John T, Margolin, Kim A, Pagoto, Sherry L, Hay, Jennifer L, Grossman, Douglas, Ellis, Darrel L, Kashani-Sabet, Mohammed, Mangold, Aaron R, Markovic, Svetomir N, Meyskens, Frank L, Nelson, Kelly C, Powers, Jennifer G, Robinson, June K, Sahni, Debjani, Sekulic, Aleksandar, Sondak, Vernon K, Wei, Maria L, Zager, Jonathan S, Dellavalle, Robert P, Thompson, John A, Weinstock, Martin A, Leachman, Sancy A, and Cassidy, Pamela B

Subjects
Biomedical and Clinical Sciences, Oncology and Carcinogenesis, Clinical Research, Clinical Trials and Supportive Activities, Prevention, Cancer, 5.1 Pharmaceuticals, 6.1 Pharmaceuticals, 3.3 Nutrition and chemoprevention, 6.9 Resources and infrastructure (treatment evaluation), Animals, Anticarcinogenic Agents, Chemoprevention, Clinical Trials, Phase III as Topic, Drug Development, Drug Repositioning, Female, Humans, Male, Melanoma, Radiation-Protective Agents, Skin Neoplasms, biomarkers, chemoprevention, human model systems, melanoma, natural products, Public Health and Health Services, Oncology & Carcinogenesis, Oncology and carcinogenesis, Public health
Abstract

Recent progress in the treatment of advanced melanoma has led to unprecedented improvements in overall survival and, as these new melanoma treatments have been developed and deployed in the clinic, much has been learned about the natural history of the disease. Now is the time to apply that knowledge toward the design and clinical evaluation of new chemoprevention agents. Melanoma chemoprevention has the potential to reduce dramatically both the morbidity and the high costs associated with treating patients who have metastatic disease. In this work, scientific and clinical melanoma experts from the national Melanoma Prevention Working Group, composed of National Cancer Trials Network investigators, discuss research aimed at discovering and developing (or repurposing) drugs and natural products for the prevention of melanoma and propose an updated pipeline for translating the most promising agents into the clinic. The mechanism of action, preclinical data, epidemiological evidence, and results from available clinical trials are discussed for each class of compounds. Selected keratinocyte carcinoma chemoprevention studies also are considered, and a rationale for their inclusion is presented. These data are summarized in a table that lists the type and level of evidence available for each class of agents. Also included in the discussion is an assessment of additional research necessary and the likelihood that a given compound may be a suitable candidate for a phase 3 clinical trial within the next 5 years.

Published
2019

25. Staging Systems for Newly Diagnosed Myeloma Patients Undergoing Autologous Hematopoietic Cell Transplantation: The Revised International Staging System Shows the Most Differentiation between Groups

Author

Scott, Emma C, Hari, Parameswaran, Kumar, Sathish, Fraser, Raphael, Davila, Omar, Shah, Nina, Gale, Robert Peter, Diaz, Miguel Angel, Agrawal, Vaibhav, Cornell, Robert F, Ganguly, Siddhartha, Akpek, Gorgun, Freytes, Cesar, Hashmi, Shahrukh, Malek, Ehsan, Kamble, Rammurti T, Lazarus, Hillard, Solh, Melhem, Usmani, Saad Z, Kanate, Abraham S, Saad, Ayman, Chhabra, Saurabh, Gergis, Usama, Cerny, Jan, Kyle, Robert A, Lee, Cindy, Kindwall-Keller, Tamila, Assal, Amer, Hildebrandt, Gerhard C, Holmberg, Leona, Maziarz, Richard T, Nishihori, Taiga, Seo, Sachiko, Kumar, Shaji, Mark, Tomer, and D'Souza, Anita

Subjects
Biomedical and Clinical Sciences, Cardiovascular Medicine and Haematology, Transplantation, Rare Diseases, Hematology, Cancer, Clinical Research, Adult, Aged, Cell Differentiation, Female, Hematopoietic Stem Cell Transplantation, Humans, Male, Middle Aged, Multiple Myeloma, Neoplasm Staging, Prospective Studies, Transplantation, Autologous, International staging system, Revised international staging system, Staging system comparison, Clinical Sciences, Immunology, Cardiovascular medicine and haematology
Abstract

The Revised International Staging System (R-ISS) and the International Myeloma Working Group 2014 (IMWG 2014) are newer staging systems used to prognosticate multiple myeloma (MM) outcomes. We hypothesized that these would provide better prognostic differentiation for newly diagnosed multiple myeloma (MM) compared with ISS. We analyzed the Center for International Blood and Marrow Transplant Research database from 2008 to 2014 to compare the 3 systems (N = 628) among newly diagnosed MM patients undergoing upfront autologous hematopoietic cell transplantation (AHCT). The median follow-up of survivors was 48 (range, 3 to 99) months. The R-ISS provided the greatest differentiation between survival curves for each stage (for overall survival [OS], the differentiation was 1.74 using the R-ISS, 1.58 using ISS, and 1.60 using the IMWG 2014) . Univariate analyses at 3 years for OS showed R-ISS I at 88% (95% confidence interval [CI], 83% to 93%), II at 75% (95% CI, 70% to 80%), and III at 56% (95% CI, 3% to 69%; P < .001). An integrated Brier score function demonstrated the R-ISS had the best prediction for PFS, though all systems had similar prediction for OS. Among available systems, the R-ISS is the most optimal among available prognostic tools for newly diagnosed MM undergoing AHCT. We recommend that serum lactate dehydrogenase and cytogenetic data be performed on every MM patient at diagnosis to allow accurate prognostication.

Published
2018

26. Human leukocyte antigens antibodies after lung transplantation: Primary results of the HALT study

Author

Hachem, Ramsey R, Kamoun, Malek, Budev, Marie M, Askar, Medhat, Ahya, Vivek N, Lee, James C, Levine, Deborah J, Pollack, Marilyn S, Dhillon, Gundeep S, Weill, David, Schechtman, Kenneth B, Leard, Lorriana E, Golden, Jeffrey A, Baxter-Lowe, LeeAnn, Mohanakumar, Thalachallour, Tyan, Dolly B, and Yusen, Roger D

Subjects
Biomedical and Clinical Sciences, Immunology, Clinical Research, Transplantation, Prevention, Lung, Organ Transplantation, Adult, Aged, Female, Follow-Up Studies, Graft Rejection, Graft Survival, HLA Antigens, Histocompatibility Testing, Humans, Isoantibodies, Lung Transplantation, Male, Middle Aged, Postoperative Complications, Prognosis, Prospective Studies, Risk Factors, Survival Rate, Tissue Donors, clinical research, practice, histocompatibility, lung transplantation, pulmonology, major histocompatibility complex, monitoring: immune, rejection: antibody-mediated, rejection: T cell mediated, clinical research/practice, lung transplantation/pulmonology, Medical and Health Sciences, Surgery, Clinical sciences
Abstract

Donor-specific antibodies (DSA) to mismatched human leukocyte antigens (HLA) are associated with worse outcomes after lung transplantation. To determine the incidence and characteristics of DSA early after lung transplantation, we conducted a prospective multicenter observational study that used standardized treatment and testing protocols. Among 119 transplant recipients, 43 (36%) developed DSA: 6 (14%) developed DSA only to class I HLA, 23 (53%) developed DSA only to class II HLA, and 14 (33%) developed DSA to both class I and class II HLA. The median DSA mean fluorescence intensity (MFI) was 3197. We identified a significant association between the Lung Allocation Score and the development of DSA (HR = 1.02, 95% CI: 1.001-1.03, P = .047) and a significant association between DSA with an MFI ≥ 3000 and acute cellular rejection (ACR) grade ≥ A2 (HR = 2.11, 95% CI: 1.04-4.27, P = .039). However, we did not detect an association between DSA and survival. We conclude that DSA occur frequently early after lung transplantation, and most target class II HLA. DSA with an MFI ≥ 3000 have a significant association with ACR. Extended follow-up is necessary to determine the impact of DSA on other important outcomes.

Published
2018

27. Myocarditis in Patients Treated With Immune Checkpoint Inhibitors.

Author

Mahmood, Syed, Fradley, Michael, Cohen, Justine, Nohria, Anju, Reynolds, Kerry, Heinzerling, Lucie, Sullivan, Ryan, Damrongwatanasuk, Rongras, Chen, Carol, Gupta, Dipti, Kirchberger, Michael, Awadalla, Magid, Hassan, Malek, Moslehi, Javid, Shah, Sachin, Ganatra, Sarju, Thavendiranathan, Paaladinesh, Lawrence, Donald, Groarke, John, and Neilan, Tomas

Subjects
cardio-oncology, checkpoint inhibitor, ipilimumab, myocarditis, nivolumab, pembrolizumab, Aged, Antineoplastic Agents, Immunological, Case-Control Studies, Female, Glucocorticoids, Humans, Male, Methylprednisolone, Middle Aged, Myocarditis, Neoplasms, Registries, Troponin T
Abstract

BACKGROUND: Myocarditis is an uncommon, but potentially fatal, toxicity of immune checkpoint inhibitors (ICI). Myocarditis after ICI has not been well characterized. OBJECTIVES: The authors sought to understand the presentation and clinical course of ICI-associated myocarditis. METHODS: After observation of sporadic ICI-associated myocarditis cases, the authors created a multicenter registry with 8 sites. From November 2013 to July 2017, there were 35 patients with ICI-associated myocarditis, who were compared to a random sample of 105 ICI-treated patients without myocarditis. Covariates of interest were extracted from medical records including the occurrence of major adverse cardiac events (MACE), defined as the composite of cardiovascular death, cardiogenic shock, cardiac arrest, and hemodynamically significant complete heart block. RESULTS: The prevalence of myocarditis was 1.14% with a median time of onset of 34 days after starting ICI (interquartile range: 21 to 75 days). Cases were 65 ± 13 years of age, 29% were female, and 54% had no other immune-related side effects. Relative to controls, combination ICI (34% vs. 2%; p < 0.001) and diabetes (34% vs. 13%; p = 0.01) were more common in cases. Over 102 days (interquartile range: 62 to 214 days) of median follow-up, 16 (46%) developed MACE; 38% of MACE occurred with normal ejection fraction. There was a 4-fold increased risk of MACE with troponin T of ≥1.5 ng/ml (hazard ratio: 4.0; 95% confidence interval: 1.5 to 10.9; p = 0.003). Steroids were administered in 89%, and lower steroids doses were associated with higher residual troponin and higher MACE rates. CONCLUSIONS: Myocarditis after ICI therapy may be more common than appreciated, occurs early after starting treatment, has a malignant course, and responds to higher steroid doses.

Published
2018

28. Effectiveness of a Peer Navigation Intervention to Sustain Viral Suppression Among HIV-Positive Men and Transgender Women Released From Jail: The LINK LA Randomized Clinical Trial

Author

Cunningham, William E, Weiss, Robert E, Nakazono, Terry, Malek, Mark A, Shoptaw, Steve J, Ettner, Susan L, and Harawa, Nina T

Subjects
Medical Microbiology, Biomedical and Clinical Sciences, Health Sciences, Health Services, Infectious Diseases, Clinical Research, Clinical Trials and Supportive Activities, HIV/AIDS, Prevention, Neurosciences, 7.1 Individual care needs, Management of diseases and conditions, Infection, Good Health and Well Being, Adult, Black or African American, Anti-HIV Agents, Case Management, Continuity of Patient Care, Female, HIV Infections, Hispanic or Latino, Humans, Logistic Models, Los Angeles, Male, Middle Aged, Patient Navigation, Peer Group, Prisons, RNA, Viral, Sustained Virologic Response, Transgender Persons, White People, Clinical Sciences, Opthalmology and Optometry, Public Health and Health Services, Clinical sciences, Health services and systems
Abstract

ImportanceDiagnosis of human immunodeficiency virus (HIV) infection, linkage and retention in care, and adherence to antiretroviral therapy are steps in the care continuum enabling consistent viral suppression for people living with HIV, extending longevity and preventing further transmission. While incarcerated, people living with HIV receive antiretroviral therapy and achieve viral suppression more consistently than after they are released. No interventions have shown sustained viral suppression after jail release.ObjectiveTo test the effect on viral suppression in released inmates of the manualized LINK LA (Linking Inmates to Care in Los Angeles) peer navigation intervention compared with standard transitional case management controls.Design, setting, and participantsRandomized clinical trial conducted from December 2012 through October 2016 with people living with HIV being released from Los Angeles (LA) County Jail. All participants were (1) 18 years or older; (2) either men or transgender women diagnosed with HIV; (3) English speaking; (4) selected for the transitional case management program prior to enrollment; (5) residing in LA County; and (6) eligible for antiretroviral therapy.Main outcomes and measuresChange in HIV viral suppression (

Published
2018

29. The Clinical Significance of Occult Gastrointestinal Primary Tumours in Metastatic Cancer: A Population Retrospective Cohort Study

Author

Hannouf, Malek B, Winquist, Eric, Mahmud, Salaheddin M, Brackstone, Muriel, Sarma, Sisira, Rodrigues, George, Rogan, Peter K, Hoch, Jeffrey S, and Zaric, Gregory S

Subjects
Biomedical and Clinical Sciences, Clinical Sciences, Oncology and Carcinogenesis, Clinical Research, Digestive Diseases, Cancer, Cohort Studies, Female, Gastrointestinal Neoplasms, Humans, Incidence, Male, Manitoba, Middle Aged, Neoplasm Metastasis, Retrospective Studies, Survival Analysis, Neoplasm metastasis, Unknown primary neoplasms, Gastrointestinal neoplasms, Information storage and retrieval, Propensity score, Research design, Cohort studies, Oncology and carcinogenesis
Abstract

PurposeThe purpose of this study was to estimate the incidence of occult gastrointestinal (GI) primary tumours in patients with metastatic cancer of uncertain primary origin and evaluate their influence on treatments and overall survival (OS).Materials and methodsWe used population heath data from Manitoba, Canada to identify all patients initially diagnosed with metastatic cancer between 2002 and 2011. We defined patients to have "occult" primary tumour if the primary was found at least 6 months after initial diagnosis. Otherwise, we considered primary tumours as "obvious." We used propensity-score methods to match each patient with occult GI tumour to four patients with obvious GI tumour on all known clinicopathologic features. We compared treatments and 2-year survival data between the two patient groups and assessed treatment effect on OS using Cox regression adjustment.ResultsEighty-three patients had occult GI primary tumours, accounting for 17.6% of men and 14% of women with metastatic cancer of uncertain primary. A 1:4 matching created a matched group of 332 patients with obvious GI primary tumour. Occult cases compared to the matched group were less likely to receive surgical interventions and targeted biological therapy, and more likely to receive cytotoxic empiric chemotherapeutic agents. Having an occult GI tumour was associated with reduced OS and appeared to be a nonsignificant independent predictor of OS when adjusting for treatment differences.ConclusionGI tumours are the most common occult primary tumours in men and the second most common in women. Patients with occult GI primary tumours are potentially being undertreated with available GI site-specific and targeted therapies.

Published
2018

30. Immune Toxicities Elicted by CTLA-4 Blockade in Cancer Patients Are Associated with Early Diversification of the T-cell Repertoire

Author

Oh, David Y, Cham, Jason, Zhang, Li, Fong, Grant, Kwek, Serena S, Klinger, Mark, Faham, Malek, and Fong, Lawrence

Subjects
Cancer, Rare Diseases, Good Health and Well Being, Antibodies, Monoclonal, CTLA-4 Antigen, Granulocyte-Macrophage Colony-Stimulating Factor, Humans, Ipilimumab, Male, Prognosis, Prostatic Neoplasms, Castration-Resistant, T-Lymphocyte Subsets, T-Lymphocytes, Regulatory, Oncology and Carcinogenesis, Oncology & Carcinogenesis
Abstract

While immune checkpoint blockade elicits efficacious responses in many patients with cancer, it also produces a diverse and unpredictable number of immune-related adverse events (IRAE). Mechanisms driving IRAEs are generally unknown. Because CTLA-4 blockade leads to proliferation of circulating T cells, we examined in this study whether ipilimumab treatment leads to clonal expansion of tissue-reactive T cells. Rather than narrowing the T-cell repertoire to a limited number of clones, ipilimumab induced greater diversification in the T-cell repertoire in IRAE patients compared with patients without IRAEs. Specifically, ipilimumab triggered increases in the numbers of clonotypes, including newly detected clones and a decline in overall T-cell clonality. Initial broadening in the repertoire occurred within 2 weeks of treatment, preceding IRAE onset. IRAE patients exhibited greater diversity of CD4+ and CD8+ T cells, but showed no differences in regulatory T-cell numbers relative to patients without IRAEs. Prostate-specific antigen responses to ipilimumab were also associated with increased T-cell diversity. Our results show how rapid diversification in the immune repertoire immediately after checkpoint blockade can be both detrimental and beneficial for patients with cancer. Cancer Res; 77(6); 1322-30. ©2016 AACR.

Published
2017

31. Antigen presentation profiling reveals recognition of lymphoma immunoglobulin neoantigens

Author

Khodadoust, Michael S, Olsson, Niclas, Wagar, Lisa E, Haabeth, Ole AW, Chen, Binbin, Swaminathan, Kavya, Rawson, Keith, Liu, Chih Long, Steiner, David, Lund, Peder, Rao, Samhita, Zhang, Lichao, Marceau, Caleb, Stehr, Henning, Newman, Aaron M, Czerwinski, Debra K, Carlton, Victoria EH, Moorhead, Martin, Faham, Malek, Kohrt, Holbrook E, Carette, Jan, Green, Michael R, Davis, Mark M, Levy, Ronald, Elias, Joshua E, and Alizadeh, Ash A

Subjects
Biomedical and Clinical Sciences, Cardiovascular Medicine and Haematology, Oncology and Carcinogenesis, Good Health and Well Being, Antigen Presentation, Antigens, Neoplasm, CD4-Positive T-Lymphocytes, Cytotoxicity, Immunologic, DNA Mutational Analysis, Epitopes, T-Lymphocyte, Exome, Genomics, HLA-D Antigens, Histocompatibility Antigens Class I, Humans, Immunoglobulin Variable Region, Immunotherapy, Lymphoma, Mantle-Cell, Mutation, Proteomics, General Science & Technology
Abstract

Cancer somatic mutations can generate neoantigens that distinguish malignant from normal cells. However, the personalized identification and validation of neoantigens remains a major challenge. Here we discover neoantigens in human mantle-cell lymphomas by using an integrated genomic and proteomic strategy that interrogates tumour antigen peptides presented by major histocompatibility complex (MHC) class I and class II molecules. We applied this approach to systematically characterize MHC ligands from 17 patients. Remarkably, all discovered neoantigenic peptides were exclusively derived from the lymphoma immunoglobulin heavy- or light-chain variable regions. Although we identified MHC presentation of private polymorphic germline alleles, no mutated peptides were recovered from non-immunoglobulin somatically mutated genes. Somatic mutations within the immunoglobulin variable region were almost exclusively presented by MHC class II. We isolated circulating CD4+ T cells specific for immunoglobulin-derived neoantigens and found these cells could mediate killing of autologous lymphoma cells. These results demonstrate that an integrative approach combining MHC isolation, peptide identification, and exome sequencing is an effective platform to uncover tumour neoantigens. Application of this strategy to human lymphoma implicates immunoglobulin neoantigens as targets for lymphoma immunotherapy.

Published
2017

32. CD4+ T-cell–independent mechanisms suppress reactivation of latent tuberculosis in a macaque model of HIV coinfection

Author

Foreman, Taylor W, Mehra, Smriti, LoBato, Denae N, Malek, Adel, Alvarez, Xavier, Golden, Nadia A, Bucşan, Allison N, Didier, Peter J, Doyle-Meyers, Lara A, Russell-Lodrigue, Kasi E, Roy, Chad J, Blanchard, James, Kuroda, Marcelo J, Lackner, Andrew A, Chan, John, Khader, Shabaana A, Jacobs, William R, and Kaushal, Deepak

Subjects
Medical Microbiology, Biomedical and Clinical Sciences, Immunology, Infectious Diseases, Rare Diseases, HIV/AIDS, Lung, Immunization, Prevention, Vaccine Related, Tuberculosis, 2.1 Biological and endogenous factors, Aetiology, Infection, Good Health and Well Being, Animals, CD4-Positive T-Lymphocytes, Cell Proliferation, Coinfection, HIV, HIV Infections, Humans, Immunologic Memory, Latent Tuberculosis, Lymphocyte Activation, Macaca mulatta, Mycobacterium tuberculosis, Simian Immunodeficiency Virus, Simian immunodeficiency virus, B cells, CD4 T cells, CD8 T cells, Nonhuman primate, tuberculosis
Abstract

The synergy between Mycobacterium tuberculosis (Mtb) and HIV in coinfected patients has profoundly impacted global mortality because of tuberculosis (TB) and AIDS. HIV significantly increases rates of reactivation of latent TB infection (LTBI) to active disease, with the decline in CD4(+) T cells believed to be the major causality. In this study, nonhuman primates were coinfected with Mtb and simian immunodeficiency virus (SIV), recapitulating human coinfection. A majority of animals exhibited rapid reactivation of Mtb replication, progressing to disseminated TB and increased SIV-associated pathology. Although a severe loss of pulmonary CD4(+) T cells was observed in all coinfected macaques, a subpopulation of the animals was still able to prevent reactivation and maintain LTBI. Investigation of pulmonary immune responses and pathology in this cohort demonstrated that increased CD8(+) memory T-cell proliferation, higher granzyme B production, and expanded B-cell follicles correlated with protection from reactivation. Our findings reveal mechanisms that control SIV- and TB-associated pathology. These CD4-independent protective immune responses warrant further studies in HIV coinfected humans able to control their TB infection. Moreover, these findings will provide insight into natural immunity to Mtb and will guide development of novel vaccine strategies and immunotherapies.

Published
2016

33. A Cross-Sectional Analysis of Late-Life Cardiovascular Factors and Their Relation to Clinically Defined Neurodegenerative Diseases

Author

Dugger, Brittany N, Malek-Ahmadi, Michael, Monsell, Sarah E, Kukull, Walter A, Woodruff, Bryan K, Reiman, Eric M, Beach, Thomas G, and Wilson, Jeffrey

Subjects
Biomedical and Clinical Sciences, Biological Psychology, Clinical Sciences, Neurosciences, Psychology, Neurodegenerative, Clinical Research, Heart Disease, Alzheimer's Disease, Dementia, Prevention, Aging, Alzheimer's Disease including Alzheimer's Disease Related Dementias (AD/ADRD), Brain Disorders, Cardiovascular, Acquired Cognitive Impairment, Nutrition, Clinical Trials and Supportive Activities, 2.1 Biological and endogenous factors, Aetiology, Neurological, Aged, Atrial Fibrillation, Body Mass Index, Cross-Sectional Studies, Databases, Factual, Diabetes Mellitus, Female, Humans, Hypertension, Male, Middle Aged, Neurodegenerative Diseases, Neuropsychological Tests, Risk Factors, Alzheimer disease, dementia with Lewy bodies, Parkinson disease, corticobasal degeneration, progressive supranuclear palsy, body mass index, Cognitive Sciences, Geriatrics, Clinical sciences, Biological psychology
Abstract

Studies have demonstrated associations between cardiovascular factors and Alzheimer disease (AD) with minimal focus on other neurodegenerative diseases. Utilizing cross-sectional data from 17,532 individuals in the National Alzheimer's Coordinating Center, Uniform Data Set, we compared the presence of cardiovascular factors [body mass index (BMI), atrial fibrillation, hypertension, hyperlipidemia, and diabetes] in individuals carrying a diagnosis of Probable AD (ProbAD), Possible AD, vascular dementia, dementia with Lewy bodies (DLB), frontotemporal dementia, Parkinson disease, progressive supranuclear palsy, or corticobasal degeneration, with that of normals. Generalized linear mixed models were fitted with age at visit, gender, and cardiovascular factors as fixed effects and Alzheimer's Disease Centers as random effects. In late life, only BMI of ProbAD and DLB patients was statistically significantly lower than that in normals (P-values

Published
2016

34. Neuropathological comparisons of amnestic and nonamnestic mild cognitive impairment

Author

Dugger, Brittany N, Davis, Kathryn, Malek-Ahmadi, Michael, Hentz, Joseph G, Sandhu, Shawn, Beach, Thomas G, Adler, Charles H, Caselli, Richard J, Johnson, Travis A, Serrano, Geidy E, Shill, Holly A, Belden, Christine, Driver-Dunckley, Erika, Caviness, John N, Sue, Lucia I, Jacobson, Sandra, Powell, Jessica, and Sabbagh, Marwan N

Subjects
Brain Disorders, Neurosciences, Alzheimer's Disease including Alzheimer's Disease Related Dementias (AD/ADRD), Alzheimer's Disease, Neurodegenerative, Aging, Acquired Cognitive Impairment, Dementia, 2.1 Biological and endogenous factors, Aetiology, Neurological, Aged, Aged, 80 and over, Amnesia, Brain, Cerebral Amyloid Angiopathy, Cerebral Infarction, Cognitive Dysfunction, Female, Humans, Leukoencephalopathies, Lewy Bodies, Male, Neurofibrillary Tangles, Parkinson Disease, Plaque, Amyloid, Temporal Lobe, Cognitive Sciences, Neurology & Neurosurgery
Abstract

BackgroundAlthough there are studies investigating the pathologic origins of mild cognitive impairment (MCI), they have revolved around comparisons to normal elderly individuals or those with Alzheimer's disease (AD) or other dementias. There are few studies directly comparing the comprehensive neuropathology of amnestic (aMCI) and nonamnestic (naMCI) MCI.MethodsThe database of the Brain and Body Donation Program ( www.brainandbodydonationprogram.org ), a longitudinal clinicopathological study of normal aging and neurodegenerative disorders, was queried for subjects who were carrying a diagnosis of aMCI or naMCI at the time of autopsy. Neuropathological lesions, including neuritic plaques, neurofibrillary tangles (NFTs), Lewy bodies (LBs), infarcts, cerebral white matter rarefaction (CWMR), cerebral amyloid angiopathy (CAA), and concurrent major clinicopathological diagnoses, including Parkinson's disease (PD) were analyzed.ResultsThirty four subjects with aMCI and 15 naMCI met study criteria. Subjects with aMCI were older at death (88 vs. 83 years of age, p = 0.03). Individuals with naMCI had higher densities of LBs within the temporal lobe (p = 0.04) while subjects with aMCI had a propensity for increased NFTs in parietal and temporal lobes (p values = 0.07). After adjusting for age at death, the only significant difference was greater densities of temporal lobe NFTs within the aMCI group. Other regional pathology scores for plaques, NFTs, and LBs were similar between groups. Subjects met clinico-pathological criteria for co-existent PD in 24 % aMCI and 47 % naMCI while neuropathological criteria for AD were met in equal percentages of aMCI and of naMCI cases (53 %); these proportional differences were not significant (p values > 0.35). Furthermore, regardless of amnestic status, there was a greater presence of CAA (71 % of MCI with executive dysfunction vs. 39 % without p = 0.03) and a greater presence of CWMR (81 % of MCI with executive dysfunction and 54 % without p = 0.046) in MCI cases with executive dysfunction.ConclusionsNo single pathologic entity strongly dichotomized MCI groups, perhaps due to the pathologic heterogeneity found within both entities. However, these data suggest the possibility for naMCI to have a propensity for increased LBs and aMCI for increased NFTs in select anatomic regions.

Published
2015

35. Concept and design of a genome-wide association genotyping array tailored for transplantation-specific studies.

Author

Li, Yun, van Setten, Jessica, Verma, Shefali, Lu, Yontao, Holmes, Michael, Gao, Hui, Lek, Monkol, Nair, Nikhil, Chandrupatla, Hareesh, Chang, Baoli, Karczewski, Konrad, Wong, Chanel, Mohebnasab, Maede, Mukhtar, Eyas, Phillips, Randy, Tragante, Vinicius, Hou, Cuiping, Steel, Laura, Lee, Takesha, Garifallou, James, Guettouche, Toumy, Cao, Hongzhi, Guan, Weihua, Himes, Aubree, van Houten, Jacob, Pasquier, Andrew, Yu, Reina, Carrigan, Elena, Miller, Michael, Schladt, David, Akdere, Abdullah, Gonzalez, Ana, Llyod, Kelsey, McGinn, Daniel, Gangasani, Abhinav, Michaud, Zach, Colasacco, Abigail, Snyder, James, Thomas, Kelly, Wang, Tiancheng, Wu, Baolin, Alzahrani, Alhusain, Al-Ali, Amein, Al-Muhanna, Fahad, Al-Rubaish, Abdullah, Al-Mueilo, Samir, Monos, Dimitri, Murphy, Barbara, Olthoff, Kim, Wijmenga, Cisca, Webster, Teresa, Kamoun, Malek, Balasubramanian, Suganthi, Lanktree, Matthew, Oetting, William, Garcia-Pavia, Pablo, MacArthur, Daniel, de Bakker, Paul, Hakonarson, Hakon, Birdwell, Kelly, Jacobson, Pamala, Ritchie, Marylyn, Asselbergs, Folkert, Israni, Ajay, Shaked, Abraham, and Keating, Brendan

Subjects
DNA Copy Number Variations, Genome-Wide Association Study, Genotype, HLA Antigens, Humans, Polymorphism, Single Nucleotide, Receptors, KIR
Abstract

BACKGROUND: In addition to HLA genetic incompatibility, non-HLA difference between donor and recipients of transplantation leading to allograft rejection are now becoming evident. We aimed to create a unique genome-wide platform to facilitate genomic research studies in transplant-related studies. We designed a genome-wide genotyping tool based on the most recent human genomic reference datasets, and included customization for known and potentially relevant metabolic and pharmacological loci relevant to transplantation. METHODS: We describe here the design and implementation of a customized genome-wide genotyping array, the TxArray, comprising approximately 782,000 markers with tailored content for deeper capture of variants across HLA, KIR, pharmacogenomic, and metabolic loci important in transplantation. To test concordance and genotyping quality, we genotyped 85 HapMap samples on the array, including eight trios. RESULTS: We show low Mendelian error rates and high concordance rates for HapMap samples (average parent-parent-child heritability of 0.997, and concordance of 0.996). We performed genotype imputation across autosomal regions, masking directly genotyped SNPs to assess imputation accuracy and report an accuracy of >0.962 for directly genotyped SNPs. We demonstrate much higher capture of the natural killer cell immunoglobulin-like receptor (KIR) region versus comparable platforms. Overall, we show that the genotyping quality and coverage of the TxArray is very high when compared to reference samples and to other genome-wide genotyping platforms. CONCLUSIONS: We have designed a comprehensive genome-wide genotyping tool which enables accurate association testing and imputation of ungenotyped SNPs, facilitating powerful and cost-effective large-scale genotyping of transplant-related studies.

Published
2015

36. Arizona Brain and Body Donation Program

Author

Beach, Thomas G, Adler, Charles H, Sue, Lucia I, Serrano, Geidy, Shill, Holly A, Walker, Douglas G, Lue, LihFen, Roher, Alex E, Dugger, Brittany N, Maarouf, Chera, Birdsill, Alex C, Intorcia, Anthony, Saxon-Labelle, Megan, Pullen, Joel, Scroggins, Alexander, Filon, Jessica, Scott, Sarah, Hoffman, Brittany, Garcia, Angelica, Caviness, John N, Hentz, Joseph G, Driver-Dunckley, Erika, Jacobson, Sandra A, Davis, Kathryn J, Belden, Christine M, Long, Kathy E, Malek-Ahmadi, Michael, Powell, Jessica J, Gale, Lisa D, Nicholson, Lisa R, Caselli, Richard J, Woodruff, Bryan K, Rapscak, Steven Z, Ahern, Geoffrey L, Shi, Jiong, Burke, Anna D, Reiman, Eric M, and Sabbagh, Marwan N

Subjects
Clinical Research, Parkinson's Disease, Brain Disorders, Neurodegenerative, Neurosciences, Aging, Neurological, Aged, 80 and over, Arizona, Autopsy, Biomarkers, Brain, Female, Humans, Male, Neurodegenerative Diseases, Organ Preservation, Postmortem Changes, Tissue Banks, Tissue Donors, Tissue Survival, Tissue and Organ Procurement, aging, Alzheimer's disease, autopsy, biobank, biospecimen, brain bank, cancer, freeze-thaw, Parkinson's disease, pathology, post-mortem interval, RNA, Clinical Sciences, Neurology & Neurosurgery
Abstract

The Brain and Body Donation Program (BBDP) at Banner Sun Health Research Institute (http://www.brainandbodydonationprogram.org) started in 1987 with brain-only donations and currently has banked more than 1600 brains. More than 430 whole-body donations have been received since this service was commenced in 2005. The collective academic output of the BBDP is now described as the Arizona Study of Aging and Neurodegenerative Disorders (AZSAND). Most BBDP subjects are enrolled as cognitively normal volunteers residing in the retirement communities of metropolitan Phoenix, Arizona. Specific recruitment efforts are also directed at subjects with Alzheimer's disease, Parkinson's disease and cancer. The median age at death is 82. Subjects receive standardized general medical, neurological, neuropsychological and movement disorders assessments during life and more than 90% receive full pathological examinations by medically licensed pathologists after death. The Program has been funded through a combination of internal, federal and state of Arizona grants as well as user fees and pharmaceutical industry collaborations. Subsets of the Program are utilized by the US National Institute on Aging Arizona Alzheimer's Disease Core Center and the US National Institute of Neurological Disorders and Stroke National Brain and Tissue Resource for Parkinson's Disease and Related Disorders. Substantial funding has also been received from the Michael J. Fox Foundation for Parkinson's Research. The Program has made rapid autopsy a priority, with a 3.0-hour median post-mortem interval for the entire collection. The median RNA Integrity Number (RIN) for frozen brain and body tissue is 8.9 and 7.4, respectively. More than 2500 tissue requests have been served and currently about 200 are served annually. These requests have been made by more than 400 investigators located in 32 US states and 15 countries. Tissue from the BBDP has contributed to more than 350 publications and more than 200 grant-funded projects.

Published
2015

37. Comparable Antigenicity and Immunogenicity of Oligomeric Forms of a Novel, Acute HIV-1 Subtype C gp145 Envelope for Use in Preclinical and Clinical Vaccine Research

Author

Wieczorek, Lindsay, Krebs, Shelly J, Kalyanaraman, Vaniambadi, Whitney, Stephen, Tovanabutra, Sodsai, Moscoso, Carlos G, Sanders-Buell, Eric, Williams, Constance, Slike, Bonnie, Molnar, Sebastian, Dussupt, Vincent, Alam, S Munir, Chenine, Agnes-Laurence, Tong, Tina, Hill, Edgar L, Liao, Hua-Xin, Hoelscher, Michael, Maboko, Leonard, Zolla-Pazner, Susan, Haynes, Barton F, Pensiero, Michael, McCutchan, Francine, Malek-Salehi, Shawyon, Cheng, R Holland, Robb, Merlin L, VanCott, Thomas, Michael, Nelson L, Marovich, Mary A, Alving, Carl R, Matyas, Gary R, Rao, Mangala, and Polonis, Victoria R

Subjects
Medical Microbiology, Biomedical and Clinical Sciences, Immunology, Vaccine Related, Infectious Diseases, Biotechnology, Prevention, Immunization, Vaccine Related (AIDS), HIV/AIDS, 3.4 Vaccines, Prevention of disease and conditions, and promotion of well-being, Development of treatments and therapeutic interventions, 5.1 Pharmaceuticals, Infection, Good Health and Well Being, AIDS Vaccines, Animals, Drug Evaluation, Preclinical, HIV Antibodies, HIV Infections, HIV-1, Humans, Leukocytes, Mononuclear, Molecular Sequence Data, Neutralization Tests, Rabbits, Vaccination, env Gene Products, Human Immunodeficiency Virus, Biological Sciences, Agricultural and Veterinary Sciences, Medical and Health Sciences, Virology, Agricultural, veterinary and food sciences, Biological sciences, Biomedical and clinical sciences
Abstract

UnlabelledEliciting broadly reactive functional antibodies remains a challenge in human immunodeficiency virus type 1 (HIV-1) vaccine development that is complicated by variations in envelope (Env) subtype and structure. The majority of new global HIV-1 infections are subtype C, and novel antigenic properties have been described for subtype C Env proteins. Thus, an HIV-1 subtype C Env protein (CO6980v0c22) from an infected person in the acute phase (Fiebig stage I/II) was developed as a research reagent and candidate immunogen. The gp145 envelope is a novel immunogen with a fully intact membrane-proximal external region (MPER), extended by a polylysine tail. Soluble gp145 was enriched for trimers that yielded the expected "fan blade" motifs when visualized by cryoelectron microscopy. CO6980v0c22 gp145 reacts with the 4E10, PG9, PG16, and VRC01 HIV-1 neutralizing monoclonal antibodies (MAbs), as well as the V1/V2-specific PGT121, 697, 2158, and 2297 MAbs. Different gp145 oligomers were tested for immunogenicity in rabbits, and purified dimers, trimers, and larger multimers elicited similar levels of cross-subtype binding and neutralizing antibodies to tier 1 and some tier 2 viruses. Immunized rabbit sera did not neutralize the highly resistant CO6980v0c22 pseudovirus but did inhibit the homologous infectious molecular clone in a peripheral blood mononuclear cell (PBMC) assay. This Env is currently in good manufacturing practice (GMP) production to be made available for use as a clinical research tool and further evaluation as a candidate vaccine.ImportanceAt present, the product pipeline for HIV vaccines is insufficient and is limited by inadequate capacity to produce large quantities of vaccine to standards required for human clinical trials. Such products are required to evaluate critical questions of vaccine formulation, route, dosing, and schedule, as well as to establish vaccine efficacy. The gp145 Env protein presented in this study forms physical trimers, binds to many of the well-characterized broad neutralizing MAbs that target conserved Env epitopes, and induce cross-subtype neutralizing antibodies as measured in both cell line and primary cell assays. This subtype C Env gp145 protein is currently undergoing good manufacturing practice production for use as a reagent for preclinical studies and for human clinical research. This product will serve as a reagent for comparative studies and may represent a next-generation candidate HIV immunogen.

Published
2015

38. Inflammatory cytokine response to exercise in alpha-1-antitrypsin deficient COPD patients ‘on’ or ‘off’ augmentation therapy

Author

Olfert, I Mark, Malek, Moh H, Eagan, Tomas ML, Wagner, Harrieth, and Wagner, Peter D

Subjects
Biomedical and Clinical Sciences, Cardiovascular Medicine and Haematology, Chronic Obstructive Pulmonary Disease, Clinical Research, Emphysema, Lung, 2.1 Biological and endogenous factors, Evaluation of treatments and therapeutic interventions, Aetiology, 6.1 Pharmaceuticals, Inflammatory and immune system, Respiratory, Aged, Analysis of Variance, C-Reactive Protein, Case-Control Studies, Cohort Studies, Cytokines, Drug Synergism, Exercise, Exercise Test, Female, Follow-Up Studies, Humans, Interleukin-1beta, Interleukin-6, Male, Middle Aged, Muscle, Skeletal, Pulmonary Disease, Chronic Obstructive, Reference Values, Respiratory Function Tests, Severity of Illness Index, Statistics, Nonparametric, Treatment Outcome, Tumor Necrosis Factor-alpha, alpha 1-Antitrypsin Deficiency, Tumor necrosis factor-alpha, C-reactive protein, Skeletal muscle, Inflammation, Cardiorespiratory Medicine and Haematology, Respiratory System, Cardiovascular medicine and haematology
Abstract

BackgroundThere is still limited information on systemic inflammation in alpha-1-antitrypsin-deficient (AATD) COPD patients and what effect alpha-1-antitrypsin augmentation therapy and/or exercise might have on circulating inflammatory cytokines. We hypothesized that AATD COPD patients on augmentation therapy (AATD + AUG) would have lower circulating and skeletal muscle inflammatory cytokines compared to AATD COPD patients not receiving augmentation therapy (AATD-AUG) and/or the typical non-AATD (COPD) patient. We also hypothesized that cytokine response to exercise would be lower in AATD + AUG compared to AATD-AUG or COPD subjects.MethodsArterial and femoral venous concentration and skeletal muscle expression of TNFα, IL-6, IL-1β and CRP were measured at rest, during and up to 4-hours after 50% maximal 1-hour knee extensor exercise in all COPD patient groups, including 2 additional groups (i.e. AATD with normal lung function, and healthy age-/activity-matched controls).ResultsCirculating CRP was higher in AATD + AUG (4.7 ± 1.6 mg/dL) and AATD-AUG (3.3 ± 1.2 mg/dL) compared to healthy controls (1.5 ± 0.3 mg/dL, p < 0.05), but lower in AATD compared to non-AATD-COPD patients (6.1 ± 2.6 mg/dL, p < 0.05). TNFα, IL-6 and IL-1β were significantly increased by 1.7-, 1.7-, and 4.7-fold, respectively, in non-AATD COPD compared to AATD COPD (p < 0.05), and 1.3-, 1.7-, and 2.2-fold, respectively, compared to healthy subjects (p < 0.05). Skeletal muscle TNFα was on average 3-4 fold greater in AATD-AUG compared to the other groups (p < 0.05). Exercise showed no effect on these cytokines in any of our patient groups.ConclusionThese data show that AATD COPD patients do not experience the same chronic systemic inflammation and exhibit reduced inflammation compared to non-AATD COPD patients. Augmentation therapy may help to improve muscle efflux of TNFα and reduce muscle TNFα concentration, but showed no effect on IL-6, IL-1β or CRP.

Published
2014

39. Effects of hospital facilities on patient outcomes after cancer surgery

Author

Knight, Sr, Chu, K, Lapitan, Mc, Dare, Aj, Pius, R, Shaw, Ca, Drake, Tm, Norman, L, Ademuyiwa, Ao, Adisa, Ao, Aguilera, Ml, Al-Saqqa, Sw, Al-Slaibi, I, Bhangu, A, Biccard, Bm, Brocklehurst, P, Costas-Chavarri, A, Elhadi, M, Fairfield, Cj, Fitzgerald, Je, Ghosh, D, Glasbey, J, Henegouwen, Miv, Ingabire, Jca, Kingham, Tp, Lawani, I, Lieske, B, Lilford, R, Martin, J, Mclean, Ka, Moore, R, Morton, D, Nepogodiev, D, Ntirenganya, F, Pata, F, Pinkney, T, Stephen, R Knight, Catherine, A Shaw, Riinu, Pius, Thomas, M Drake, Lisa, Norman, Adesoji, O Ademuyiwa, Adewale, O Adisa, Maria Lorena Aguilera, Sara, W Al-Saqqa, Ibrahim, Al-Slaibi, Aneel, Bhangu, Bruce, M Biccard, Peter, Brocklehurst, Ainhoa, Costas-Chavarri, Kathryn, Chu, Anna, Dare, Muhammed, Elhadi, Cameron, J Fairfield, J Edward Fitzgerald, Dhruv, Ghosh, James, Glasbey, Mark, I van Berge Henegouwen, C Allen Ingabire, J, T Peter Kingham, Marie Carmela Lapitan, Ismaïl, Lawani, Bettina, Lieske, Richard, Lilford, Janet, Martin, Kenneth, A McLean, Rachel, Moore, Dion, Morton, Dmitri, Nepogodiev, Faustin, Ntirenganya, Francesco, Pata, Thomas, Pinkney, Ahmad Uzair Qureshi, Antonio Ramos-De la Medina, Aya, Riad, Hosni Khairy Salem, Joana, Simões, Richard, Spence, Neil, Smart, Stephen, Tabiri, Hannah, Thomas, Thomas, G Weiser, Malcolm, West, John, Whitaker, Ewen, M Harrison, Arben, Gjata, Maria Marta Modolo, Sebastian, King, Erick, Chan, Sayeda Nazmun Nahar, Ade, Waterman, Dominique, Vervoort, Alemayehu Ginbo Bedada, Bernardo De Azevedo, Ana Gabriela Figueiredo, Manol, Sokolov, Venerand, Barendegere, Gerald, Ekwen, Arnav, Agarwal, Qinyang, Liu, Juan Camilo Correa, Kalisya Luc Malemo, Jacques, Bake, Jakov, Mihanovic, Kamila, Kunčarová, Julius, Orhalmi, Hosni, Salem, Jyri, Teras, Aristotelis, Kechagias, Alexis, P Arnaud, Judith, Lindert, Vasileios, Kalles, Maria-Lorena, Aguilera-Arevalo, Gustavo, Recinos, Zsolt, Baranyai, Basant, Kumar, Harish Neelamraju Lakshmi, Sanoop Koshy Zachariah, Philip, Alexander, Sunil Kumar Venkatappa, Pramesh, C, Radhian, Amandito, Christina, Fleming, Luca, Ansaloni, Gianluca, Pellino, Ahmed, M Altibi, Ibrahim, Nour, Intisar, Hamdun, Ali, M Ghellai, Donatas, Venskutonis, Tomas, Poskus, Justas, Zilinskas, Precious, Malemia, Yong Yong Tew, Elaine, Borg, Sarah, Ellul, Fatima Zahraa Wafqui, David, W Borowski, Anne Sophie van Dalen, Cameron, Wells, Harissou, Adamou, Adesoji, Ademuyiwa, Adewale, Adisa, Kjetil, Søreide, Sara Al Saqqa, Osaid, Alser, Haya, Tahboub, Helmut Alfredo Segovia Lohse, Sebastian Shu Yip, Piotr, Major, António Sampaio Soares, Matei Razvan Bratu, Andrey, Litvin, Armen, Vardanyan, Ahmad, Gudal, Naif, Albati, Jovan, Juloski, Miran, Rems, Sarah, Rayne, Stephanie Van Straten, Yoshan, Moodley, Irene Ortega Vázquez, Jaime, Ruiz-Tovar, Kithsiri Janakantha Senanayake, Sujeewa Priyantha Bandara Thalgaspitiya, Omer Abdelbagi Omer, Anmar, Homeida, Yucel, Cengiz, Daniel, Clerc, Muhammad, Alshaar, Hanen, Bouaziz, Yuksel, Altinel, Matthew, Doe, Maryna, Freigofer, Ella, Teasdale, Rakan, Kabariti, Joshua Michael Clements, Stephen Richard Knight, Ahsan, Ashfaq, Ijeoma, Azodo, Gabriela, Wagner, Ivan, Trostchansky, Mayaba, Maimbo, David, Linyama, Helidon, Nina, Amanda, Zeko, Claudio Gabriel Fermani, Santiago, Villalobos, Federico, Carballo, Pablo, Farina, Sebastian, Guckenheimer, Marilla, Dickfos, Ankit, Ajmera, Chester, Chong, Ralph, Gourlay, Sikandar, Hussaini, Yi Jia Lee, Adeeb, Majid, Peter, Martin, Rebecca, Miles, Owen James Morris, Jamie, Phua, William, Ridley, Tarunpreet, Saluja, Ryan Renxin Tan, Jen, Teh, Anna, Wells, Bharti, Arora, Qaasim, Dollie, Debbie, Ho, Yanru, Ma, Omattage Mahasha Perera, Anthony, Truong, Amanda Caroline Dawson, Bryan, Lim, Upuli, Pahalawatta, Jacqueline, Phan, Xiao-Ming Sarah Woon-Shoo-Tong, Andrea, Yeoh, Lillian, Charman, Andrew, Drane, Sharon, Laura, Charmaine Chu Wen Lo, Amy, Mozes, Rita, Poon, Hao Han Tan, Ellen, Wall, Prakshi, Chopra, Jasmine De Giovanni, Bal, Dhital, Brian, Draganic, Alexander, Duller, Jonathan, Gani, Yao Kuan Goh, Jun Young Jeong, Brendan, Mcmanus, Prakash, Nagappan, Peter, Pockney, Anya, Rugendyke, Mahsa, Sarrami, Stephen, Smith, Vanessa, Wills, Hsu Ven Wong, Geoffrey, Ye, Geoffrey, Zhang, Ethan, Brooker, Daniel, Feng, Bonnie, Lau, Carlin, Ngai, Sarah, Birks, David, Gyorki, Jaime Otero de Pablos, Ali, Abbosh, Chris, Gillespie, Ahmed, Mahmoud, Bianca, Kwan, Joshua, Lawson, Andrea, Warwick, Janne, Bingham, Andrew, J Cockbain, Nagendra Naidu Dudi-Venkata, Jordan, Ellaby-Hall, Ben, Finlay, Emily, Humphries, Jade, Pisaniello, Monique, Pisaniello, Salma, Salih, Tarik, Sammour, Haidar Hadri Abd Wahab, April De Silva, Nicola, Hayward, Kartik, Iyer, Guy, Maddern, Gian Andrea Prevost, Naga, Annapureddy, Krishna Pranathi Settipalli, Jeremy, Yeo, Lucy, Hempenstall, Lily, Pham, Shaun, Purcell, Cherry, Talavera, Ashish, I Vaska, Gurpreet, Chaggar, Phillip, Chrapko, Annelise, Cocco, Sarah Michelle Crystal Jade Coulter-Nile, Grahame, Ctercteko, James, French, Houchen, Gong, Martijn, Gosselink, Thuvarahan, Jegathees, Ivan, Jin, Michelle, Kalachov, Kathryn, Kiefhaber, Katherine, Lee, Jason, Luong, Steven, Phan, Henry, Pleass, Kelly, Veale, Zhi, Zeng, Angela, Au, Ashe, Debiasio, Idy, Deng, Jananee, Myooran, Amrita, Nair, Peter, Stewart, Anton, Stift, Lukas Walter Unger, Kerstin, Wimmer, Nabila, Ahmed, Syed, Hasan, Saber, Rahman, Margaret, O'Shea, Greg, Padmore, Adrian, Peters, Pietro, Perduca, Guenda, Pulcina, Nicolas, Tinton, Frederic, Buxant, Elsa, Dabin, Giulia, Garofalo, Francis, Dossou, Freddy Houehanou Rodrigue Gnangnon, Yacoubou Imorou Souaibou, Pako, Motlaleselelo, Omphile, Tlhomelang, Igor Lima Buarque, Gustavo Mendonça Ataíde Gomes, Aldo Vieira Barros, Ilia, Batashki, Nikolai, Damianov, Vladislav, Stoyanov, Dragomir, Dardanov, Svilen, Maslyankov, Plamen, Petkov, George, Todorov, Evgeni, Zhivkov, Aygulya, Akisheva, Miguel Angel Castilla Moreno, Geno, Genov, Ivelina, Ilieva, Tsvetomir, Ivanov, Martin, Karamanliev, Azhar, Khan, Emil, Mitkov, Tsanko, Yotsov, Boyko, Atanasov, Nikolay, Belev, Mihail, Slavchev, Carlos, Nsengiyumva, Elgan, Jones, Simon, Stock, Steve, Kyota, James, Brown, Tresor Mabanza, K, Lemery Nigo Samuel, Chidi, Otuneme, Ngwang, Prosper, Franklin, Umenze, Marylise, Boutros, Natasha, Caminsky, Sinziana, Dumitra, Richard, Garfinkle, Dominique, Morency, Ebram, Salama, Alexander, Banks, Lorenzo, Ferri, Haitian, He, Amit, Katz, Alexander Sender Liberman, Sarkis, Meterissian, Allison, Pang, Elena, Parvez, Usmaan, Hameed, Fahima, Osman, Sangita, Sequeira, Natalie, Coburn, Alisha, Jaffer, Paul, Karanicolas, Matthew, Mosseler, Reilly, Musselman, Xinyuan, Liu, Ching Wan Yip, Juan Sebastian Garces-Otero, Carolina, Guzman, Sebastian, Sierra, Andres Uribe Valencia, Paulo Andrés Cabrera Rivera, Saul, Camelo, Andrea, Gonzalez, Alejandro, González-Orozco, Manuel Santiago Mosquera Paz, Carlos J- Perez Rivera, Felipe, Gonzalez, Andres, Isaza-Restrepo, Laura, Nino-Torres, Natalia Arias Madrid, Maria Clara Mendoza Arango, Justin, Tsandiraki, Damir, Jemendžić, Branislav, Kocman, Oliver, Šuman, Renata, Canic, Darko, Jurišić, Ivana, Karakas, Ana Krizanovic Rupcic, Vlatka, Pitlovic, Josip, Samardžić, Mario, Kopljar, Ivan, Bacic, Edgar, Domini, Robert, Karlo, Danijela, Miljanić, Andrea, Simic, Mariam, Ahmed, Majdi Al Nassrallah, Rabiya, Altaf, Talal, Amjad, Ruba, Eltoum, Heba, Haidar, Alhassan, Hassan, Omar, Khalil, Marwan, Qasem, Rommel, Ramesh, Gautham, Sajith, Maham, Wisal, Jan, Žatecký, Michele, Bujda, Katerina, Jirankova, Ales, Paclik, Aya, Abdallah, Mariam Abdulgawad Almogy, Esraa Ayman El-Sawy, Ahmed Moustafa ElFayoumy, Nourhan, Elghareeb, Nourhan Ahmed Esmat, Ahmed, Fadel, Abdullah, Habater, Heba, Hamdy, Amr, Hefni, Marwa, Kamal, Norhan Mohamed Abobakr, Ahmed, Sayed, Nancy, Shaker, Ehab, Taha, Hoda, Tharwat, Omar, Zakaria, Ibrahem, Abdelmotaleb, Ali, Al-Dhufri, Hamza, S Al-Himyari, Enas El Sheikh, Asmaa, Eldmaty, Aya, Elkhalawy, Ahmed, M Elkhashen, Kithara, Magdy, Safa, Mostafa, Habib Doutoum Sadia, Mohamed Mahmoud Saleh, Dina, Samir, Mohamed Yahia Mohamed Ali, Mahmoud, A Nassar, Samar, Abdelhady, Aly, Abdelrazek, Israa, Abdelsalam, Aya, El-Sawy, Eman, Essam, Mohamed, Gadelkarim, Khaled, Ghaly, Mohamed, Hassabalnaby, Rana, Masarani, Nourhan Mohamed Shaaban, Ahmed, Sabry, Menatalla, Salem, Nourhan Akram Soliman, Diaaaldin, Zahran, Moustafa Ramadan Abou El Soud, Esraa Tarek Badr, Hala, Borham, Nehal, Elmeslemany, Mohammad, Elsayed, Fawzia, Elsherif, Sara, Eslam, Gehad, Gaber, Sondos, Ibrahim, Yara, Kamh, Abdelrahman, Mahmoud, Shimaa Gamal Mohamed, Eman, Morshedy, Cinderella, Omar, Fatima Salem Soliman, Shaza, Abdelkawy, Naglaa, Abdelmohsen, Mahmoud, Abdelshakour, Ahmed, Dahy, Norhan, Gamal, Mohammed, Gamal, Ahmad, Hasan, Helal, Hetta, Nehad, Mousa, Mohamed, Omar, Somia, Rabie, Mahmoud, Saad, Bakeer, Saleh, Marwa Sayed Mohamed, Muhammad, Shawqi, Heba Abdelhady Mousa, Mostafa, Alnoury, Mohamed, Elbealawy, Ahmed, Elshafey, Muhammad Essam Ibrahim El Desouki Muhammad Ahmed, Mennatullah, Ghonaim, Fawzy, Hgag, Mohamed, Ibrahim, Mahmoud, Morsy, Mohamed Reda Loaloa, Ahmed, Refaat, Hadeer, Samir, Fatma, Shahien, Mohamed, Sobhy, Fathy, Sroor, Esraa, Abdellatif, Marina, Adel, Amr Abdelghani Afifi, Eman, Afifi, Marco, Antaky, Amr, Dawoud, Naira El Zoghby, Amira, El-Remaily, Ali Abdelazez Elzanfaly, Ahmed, Gadallah, Fatma Alzahraa Gamal, Omar, Hashem, Shrouk Medhat Youssef, Aliaa Muhammad Attyah, Malak, Munir, Omar, Shazly, Esraa, Taha, Karim, Wilson, Sawsan, Adel, Asmaa, Ali, Esraa, Eid, Esraa, Elhelow, Marwa, Elmahdy, Bassant, Elshatby, Amany Hossam El-Din Zakaria, Ahmad, Hossny, Eman, Ibrahim, Ahmed, M Yonis, Maram, Metwalli, Basant, Yousry, Esraa, Zid, Mina, A Yacoub, Ahmed, Abdelhakim, Nervana, Abouelsoad, Mo'Min, Alkhatib, Ahmed, Ashraf, Alaa, Ashraf, Yasmin, Elazab, Mahmoud, Elfanty, Osama, Elkabir, Mai, Elsayed, Ahmed, Elshimy, Hager, Elsobky, John, Eskander, Ahmed, Gad, Ward, Hamsho, Noura Khaled Abdelwahed, Menna, Magdy, Dalia, Moharam, Abeer, Osama, Shereen, Ramadan, Radwa, Roum, Taqwa, Sayed, Tarneem, Shehada, Ahmed Mohy Zidan, Khalid, Abbas, Amr, Ali, Mohamed, Attia, Mohamed, Balata, Ayman El Nakeeb, Mohamed Ibrahim Elsayed Elewaily, Ahmed, Elfallal, Hossam, Elfeki, Ahmed, Elkhadragy, Sameh, Emile, Helmy, Ezzat, Hasnaa, Hosni, Islam, Mansour, Waleed, Omar, Gehad, Othman, Kareem, Sadek, Mostafa, Shalaby, Noura, Shehab-Eldeen, Rawda Anas Khalifa, Helmy, Badr, Mostafa, Eldeep, Ahmed, Eldeep, Amany Eldoseuky Mohammed, Salwa, Khallaf, Eman Magdy Hegazy, Rokia, Mahmoud, Pola, Mikhail, Mahmoud, Morsi, Sara, Mowafy, Dina, Raafat, Amina, Safy, Marwa, Sera, Ahmed Shible Sera, Mostafa Salim Mohamed AbdAllah, Muhammad, Abdelkader, Abdulrahman Osama Abdou, Ahmedgaber, Ahmed, Shireen, Gaafar, Fatma Ibrahim Negm, Mina, Lapic, Ahmed, Maher, Hagar, Mahmoud, Ahmed, Mostafa, Mohamed, Samir, Fatma, Samy, Nourhan, Semeda, Hind, I Shalaby, Alaa, El-Taweel, Ahmed Galal Elnagar, Ahmed Gamal Hemidan, Mohamed, Hussein, Ahmed, A Kandil, Moawad, Mf, Ayat Allah Nasser Hamamah, Mostafa, Soliman, Mohamed, Abdelkhalek, Noura Abdelmaksoud Tawakel, Ahmed Mohamed Abdelwahed, Alrawy, Abdou, Khalid, Atallah, Mohammed Yasser Elsherbeny, Eman, Emara, Mohamed, Hamdy, Omar, Hamdy, Amira, Haron, Salma, Ismail, Islam Hany Metwally, Nihal Mohamed Hamed Elgaml, Ahmed, Nassar, Basel, Refky, Mirna, Sadek, Mahmoud, Saleh, Asmaa, Yunes, Mai, Zakaria, Mohammed, Zuhdy, Notila, Fayed, Mohammed Mustafa Hassan Mohammed, Sander, Kütner, Priit, Melnik, Indrek, Seire, Toomas, Ümarik, Eppu, Ainoa, Verner, Eerola, Hanna, Koppatz, Laura, Koskenvuo, Ville, Sallinen, Sini, Takala, Jevgeni, Katunin, Arto, Turunen, Niki, Christou, Muriel, Mathonnet, Vincent, Lavoue, Krystel Nyangoh Timoh, Lucie, Soulabaille, Romain, Lesourd, Aude, Merdrignac, Laurent, Sulpice, Benoît, André, Elodie, Chantalat, Charlotte, Vaysse, Bertrand, Dousset, Sebastien, Gaujoux, Gregory, Martin, Octavian, Clonda, Domantas, Juodis, Klaus, Kienle, Andras, Mravik, Samuel, Palmer, Gabor, Szabadhegyi, Anita Eseenam Agbeko, Solomon, Gyabaah, Frank Enoch Gyamfi, Nuhu, Naabo, Atta Owusu Senior, Joseph, Yorke, Frank, Owusu, Francis, Abantanga, Theophilus Teddy Kojo Anyomih, Abdul-Jalilu Mohammed Muntaka, Emmanuel Owusu Abem, Mohammed, Sheriff, Paul, M Wondoh, Dimitrios, Balalis, Dimitrios, Korkolis, Georgios, Gkiokas, Eirini, Pantiora, Theodosios, Theodosopoulos, Argyrios, Ioannidis, Konstantinos, Konstantinidis, Sofia, Konstantinidou, Nikolaos, Machairas, Anna, Paspala, Anastasia, Prodromidou, Christos, Chouliaras, Konstantinos, Papadopoulos, Ioannis, Baloyiannis, Ioannis, Mamaloudis, George, Tzovaras, Ioanna, Akrida, Maria-Ioanna, Argentou, Stylianos, Germanos, Evangelos, Iliopoulos, Ioannis, Maroulis, George, Skroubis, George, Theofanis, Christos, Chatzakis, Orestis, Ioannidis, Lydia, Loutzidou, Panagiotis, Karathanasis, Nikolaos, Michalopoulos, Charalampos, Theodoropoulos, Dimitrios, Theodorou, Tania, Triantafyllou, Zoe, Garoufalia, Natasha, Hasemaki, Michalis, Kontos, Gregory, Kouraklis, Stylianos, Kykalos, 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Telma, Fonseca, Jorge, Pereira, Juan, Rachadell, Ana, Torre, Filipe Madeira Martins, Ana Cristina Carvalho, Joana Rodrigues Ferreira, Bruno Ribeiro da Silva, Helena, Devesa, Ana, Vieira, Inês, Mónica, Margarida, Amaro, Diogo, Sousa, Marta, Reia, João, Louro, Ana, Martins, Joaquina, Dominguez, Inês, Santos, Nuno Miguel Freitas Oliveira, José Carlos Pereira, Pedro, Silva-Vaz, Ligia, Freire, Ricardo, Escrevente, Valentina Madalina Negoita, Dmitry, Shakhmatov, Yves, Nezerwa, Radosav, Radulovic, Gareth, Obery, Francois, Viljoen, Tome, Mendes, Antonio, Suarez, Enrique, Moncada, Maria, Fernandez-Hevia, Carolina Curtis Martínez, Julia Maria Gil Garcia, Mariana González Zunzarren, Tarig, Idris, Karolina, Eklöv, Oskar, Grahn, Leila, Amin, Malin, Blomqvist, Costanza, Ajani, Rebecca, Kraus, Nico, Seeger, Melissa, Willemin, Fadi, Rayya, Mohammad, Ayash, Raneem, Msouti, Israa, Kannas, Eias, Abazid, Asil, Esper, Skander, Slim, Akil Serdar Kavcar, Erman, Aytac, Ahmet Cem Dural, Ayse, Ilker, Ismail Cem Eray, Eray, Kurnaz, Saygin, Altiner, Mustafa Deniz Tepe, Can, Şahin, Evrim, Savli, Aryon, Innocent, Lilian, Babirye, Andrii, Diachenko, Vladislav, Hordoskiy, Heather, Curry, Charlene Yat Che Chau, Harry, Robertson, Arin, Mahmoud, Hannah, Lennon, Lynette, Loi, Emily, Kirkham, Cameron, Mccann, Daniel, Watts, Binay, Gurung, Michael, Wilson, Thomas, Tribedi, Eleonora, Garofalo, Baryab, Zahra, Scott, Macdonald, Ian, Daniels, Nathan, Ng, Shivun, Khosla, James, Olivier, Sum Yu Pansy Yue, Gayathri, Suresh, Jack, Wellington, Emmanuel, Lorejo, Mafdi, Mossaad, Madison, Crutcher, Marjan, Alimi, Ioana, Baiu, Hossam, Abdou, Alison, Conway, Connor, Peck, Mauro Andres Perdomo Perez, Stanley, Zulu, Mildred, Nakazwe, Sule, Burger, Justine, Davies, Rachel, Donaldson, Chikwendu, Ede, O James Garden, Chiapo, Lesetedi, Charles, Mabedi, Laura, Magill, Felix Makinde Alakaloko, Alex, Makupe, Mark, Monahan, Soloman, Mulira, Elmi, Muller, Jospeh, Musowoyo, Jean Léon Olory-Togbe, Tracey, Roberts, Martin, Smith, 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Harmony Impellizzeri, Marco Inama, Gianluigi Moretto, Sylvie Mochet, Elisa Ponte, Antonella Usai, Stefano Mancini, Andrea Sagnotta, Luigi Solinas, Elisa Bolzonaro, Nicolò Tamini, Gianluca Curletti, Raffaele Galleano, Michele Malerba, Sofia Campanella, Gianfranco Cocorullo, Francesco Colli, Paolino De Marco, Nicolò Falco, Tommaso Fontana, Leonel Jospin Kamdem Mambou, Antonella La Brocca, Leo Licari, Brenda Randisi, Giovanna Rizzo, Giulia Rotolo, Giuseppe Salamone, Roberta Tutino, Paolina Venturelli, Stefano Malabarba, Alessandro Sgrò, Ivan Vella, Bruno Cirillo, Daniele Crocetti, Giorgio De Toma, Pierfrancesco Lapolla, Andrea Mingoli, Paolo Sapienza, Angela Belvedere, Stefania Bianchini, Margherita Binetti, Arianna Birindelli, Valeria Tonini, Mauro Podda, Fabio Pulighe, Michele De Rosa, Lorenzo Bono, Felice Borghi, Paolo Geretto, Maria Carmela Giuffrida, Corrado Lauro, Alessandra Marano, Luca Pellegrino, Paola Salusso, Diego Sasia, Michela Campanelli, Alberto Realis Luc, Mario Trompetto, Roberto Cardia, Nicola Cillara, Antonio Nicola Giordano, Antonio Costanzo, Mario Alessandro Giovilli, Luca Turati, Silvestro Canonico, Gianluca Pellino, Guido Sciaudone, Francesco Selvaggi, Lucio Selvaggi, Nader Albsoul, Ahmad AlBsoul, Ala'a Aldeen Alkhatib, Osama Alsallaq, Justin Z Amarin, Rami Ayoub, Isam Bsisu, M S El Muhtaseb, Mohammad Jabaiti, Jamal Melhem, Ibrahim Nour, Yasmeen Z Qwaider, Mohammad Hasan Salameh, Ahmad Suleihat, Haya H Suradi, Mohammad Alammarin, Almoutuz Aljaafreh, Mohammad Bani Hani, Zeina Bani Hani, Farah Bani Hani, Toqa Fahmawee, Shadi Hamouri, Cyrine Katanani, Ra'fat Tawalbeh, Tamara Tawalbeh, Hassan Zawahrah, Mohamad K Abou Chaar, Lana Abusalem, Mahmoud Al-Masri, Hani Al-Najjar, Lutfi Barghuthi, Zahra Ahmed, Adnan Maulana, Omar Ngotho, Charbel Kamau, Aruyaru Stanley Mwenda, Fridah Bosire, Elizabeth Mwachiro, Robert Parker, Ian Simel, Kimutai Sylvester, Abdulmunem Ahmed Mustafa Althini, Sofian Elbarouni, Aya Elseed Elbeshina, Ahmed Gwea, Ans Malek, Wedad Albashir Masoud Farag, Abdulwahab Abdalei, Abu Baker Abdel Malik, Areej Abo-Khammash, Ma'aly Abuhlaiga, Nour Adnan, Marwa Albaggar, Asma Alfitory, Asma Aljanfi, Fakhruddin Almuzghi, Zohoor Altumei, Fatima Alzabti, Hana Ashoushan, Mohamed Assalhi, Joma Azzubia, Sondos Bnhameida, Malik Delhen, Houssein Elshafei, Hana Elteir, Fatima Esbaga, Abdel Aziz Gobbi, Fatma Hamouda, Hamdan Hilan, Rania Ismail, Fieruz Jebran, Muataz Kasbour, Galia Maderi, Saja Mohammad, Burooj Mohammed, Habib Murtadi, Hamassat Mustafa, Mohamed Rajab, Sarah Trenba, Mariam Wafaa, Eman Al Sagheir, Alabas Almigheerbi, Ahmed Alzahaf, Sumayyah Ghayth Bahroun, Najah Ben Dallah, Mahmoud Elshaibani, Haitem Eswaye, Maha Karar, Samah Omar, Eman Younes, Maha Younes, Dafer Zreeg, Saleh Abujamra, Firas Ashour, Mala Elgammudi, Wesal Omar F Aljadidi, Enas Saddouh, Randa Sharif, Aya Alabuzidi, AbdulMawlay Alwerfally, Sarra Aribi, Fatma Bibas, Taha Elfaituri, Yasmine Elhajjaji, Ala Khaled, Wegdan Khalil, Tesneem Layas, Enas Soula, Ahmed Tarek, Muad Fathi Khalleefah Abu Hallalah, Saleh Abujamra, Hazem Abdelkarem Ahmed, Tagwa Alsharef, Abdulsalam Ali Ben Saoud, Tasnim El Gharmoul, Ahmed Elhadi, Safa Elrais, Abdulhalim Shebani, Heba Zarti, Asaid Zeiton, Marijus Ambrazevicius, Nerijus Kaselis, Migle Stakyte, Oleg Aliosin, Agne Cizauskaite, Sarunas Dailidenas, Vitalijus Eismontas, Migle Kybransiene, Vitalija Nutautiene, Narimantas Samalavicius, Dainius Simcikas, Algirdas Slepavicius, Albinas Tamosiunas, Nerijus Ubartas, Paulius Zeromskas, Saulius Bradulskis, Edvinas Dainius, Juozas Juočas, Egle Kubiliute, Juozas Kutkevičius, Aurimas Opolskis, Audrius Parseliunas, Andrejus Subocius, Donatas Venskutonis, Egle Virbickaite, Diana Zuikyte, Algirdas Bogusevicius, Kristina Buzaite, Daiva Čepuliené, Ieva Cesleviciene, Vaidotas Cesna, Jolanta Gribauskaite, Povilas Ignatavicius, Mantas Jokubauskas, Monika Liugailaitè, Ernest Margelis, Ruta Mazelyte, Lina Pankratjevaitè, Matas Pažusis, Agne Rackeviciute, Justina Saladyte, Monika Škimelytè, Vygintas Šlenfuktas, Monika Sudeikyte, Algimantas Tamelis, Tomas Vanagas, Žygimantas Žumbakys, Aivaras Atkociunas, Audrius Dulskas, Justas Kuliavas, Justas Birutis, Sigitas Paškevičius, Mindaugas Šatkauskas, Donatas Danys, Matas Jakubauskas, Lina Jakubauskiene, Marius Kryzauskas, Vytautas Lipnickas, Gabija Makūnaitè, Fanjandrainy Rasoaherinomenjanahary, Herizo Rasolofonarivo, Luc Hervé Samison, Bitiel Banda, Precious Malemia, Vanessa Msosa, Ahmad Imran Ahmad Izzuddin, Andre Das, Ying Yee Gan, Tan Shong Sheng, Jia Yng Siaw, Mohd Fadliyazid Ab Rahim, Dyg Zahratul Hamrak Abang Jamari, Nurfariza Che Husin, Muhd Yusairi Kamarulzaman, Yi Ping Lim, Nil Amri Mohamed Kamil, Mohd Razeen Mohd Hassan, Saidah Mohd Sahid, Johari Mustafa, Elaine Hui Been Ng, Wan Khamizar Wan Khazim, Ng Chang Ern, P G Lingeshan, Syariz Ezuan Sulaiman, Sue Ean Ang, Muhammad Navid Bin Mohamad Sithik, Yih Jeng Cheong, Mahadevan Deva Tata, Law Jia Xian, Aravinthan Kadravello, I-Ern Koh, Li-Yen Ng, Yuki Julius Ng We Yong, Kandasami Palayan, Chi Xuan Sam, Phuah Siow Jin, Jeremy Tan Ern Hwei, Yita Tang, Alvin Zubin Ter, Michael Pak-Kai Wong, Andee Dzulkarnaen Zakaria, Zaidi Zakaria, Fitjerald Henry, Thyivya Kalaiselvan, Muhammad Fairuz Shah Abd Karim, Mohamed Rezal Abdul Aziz, Nora Abdul Aziz, Tak Loon Khong, Peng Choong Lau, Hiong Chin Lim, April Camilla Roslani, Jonathan Chen Ken Seak, Sui-Weng Wong, Lai Fen Wong, Leow Yeen Chin, Mercy Chinemerem Anyanwu, Elaine Borg, Zachary Busuttil, Thomas Calleja, Kurt Lee Chircop, Ruth Cutajar, Andrew Michael Dimech, Sarah Ellul, Joseph Galea, Kiara Gascon Perai, Ruth Gatt, Lisa Kelman, Elizabeth Micallef, Favour Nwolu, Kim Sammut, Joanna Thompson, Sean Warwicker, Matthew Zammit, Fernando Cordera, Efraín Cruz González, Jorge Sánchez-García, Francisco José Barbosa Camacho, Francisco Javier Barrera López, Carlos Jose Zuloaga Fernandez Del Valle, Eric Acosta, Iván Romarico González Espinoza, Perla Moreno, Ana Olivia Cortes-Flores, Clotilde Fuentes Orozco, Alejandro Gonzalez Ojeda, Samantha Corro Díaz González, Laura Martinez, Antonio Ramos-De la Medina, Bonifacio Mosqueda Amador, Armando Novoa, Dennet Arturo Olazo Espejo, Alejandro Jimenez, Federico Lopez Rosales, Elva Gabriela Vanoye, Luis Alberto Garcia Gonzalez, Roberto Carlos Miranda-Ackerman, Manuel Solano-Genesta, Alethia Alvarez-Cano, Hector Hugo Romero-Garza, Heriberto Medina-Franco, Lorelí Mejía-Fernández, Noel Salgado-Nesme, Omar Vergara-Fernandez, Guadalupe Montserrat Gutiérrez-Mota, Francisco Xavier Hernandez Vera, Anabella Llantada Lopez, Gilberto Morgan Villela, Felipe de Jesus Ramirez Padilla, Walezka Tapia Marin, Mónica Martínez Maldonado, Ramses Sánchez Suárez, José Manuel Troche, Chaymae Benyaiche, Oumaima Outani, Souadka Amine, Amine Benkabbou, Anass Mohammed Majbar, Raouf Mohsine, Ali Rafik, Thida Oung, Moe Moe Tin, David W Borowski, Philipp Plarre, David W Borowski, Philipp Plarre, Anna Alberga, Nina Sluiter, Jurriaan Tuynman, Robin Blok, Didem Cömert, Roel Hompes, Marianne Kalff, Merel Elisabeth Stellingwerf, Pieter Tanis, Mark van Berge Henegouwen, Elise Maria van Praag, Daan Wisselink, Michael Gerhards, Josephine Lopes Cardozo, Emma Westerduin, Joske de Jonge, Aaw van Geloven, Kaz van Schilt, Frank den Boer, Simone Stoots, Stijn Vlek, Jamie Adams, Ibrahim S Al-Busaidi, Gabrielle Budd, Seung Il Choi, Michael Jen Jie Chu, Anurag Ganugapati, Lucy McKinstry, Rebecca Pascoe, Simon Richards, Kenrick Rosser, Annie Stevenson, Rebecca White, Shebani Farik, Jin Kwun, Ahmed Murad, Sarah Cowan, Timothy Hall, Michael Hayton, Laminou Malam Sani, Souleymane Oumarou Garba, Harissou Adamou, Ibrahim Amadou Magagi, Oumarou Habou, Halima Aliyu, Muhammad Daniyan, Tunde T Sholadoye, Lawal Abdullahi, Lofty-John Anyanwu, Aminu Mohammad Mohammad, Abubakar Bala Muhammad, Abdurrahman Abba Sheshe, Ibrahim Suleiman, Alaba Adesina, Ajibola Awolowo, Clement Onuoha, Omotayo Salami, Ogechukwu Taiwo, Agboola Taiwo, Stephen Kache, Jerry Godfrey Makama, Danjuma Sale, Olajide Abiola, Akinlabi Ajao, Anthony Ajiboye, Amarachukwu Etonyeaku, Julius Olaogun, Ademola Adebanjo, Opeoluwa Adesanya, Michael Olatunji Afolayan, Olanrewaju Balogun, Ayomide Makanjuola, Samuel Nwokocha, Rufus Wale Ojewola, Thomas Olagboyega Olajide, Adewale Aderounmu, Abdul-Rashid Adesunkanmi, Adewale Adisa, Augustine Agbakwuru, Adeleke Akeem Aderogba, Olusegun Isaac Alatise, Olukayode Arowolo, Oladejo Lawal, Tajudeen Mohammed, Chinedu Ndegbu, Olalekan Olasehinde, Funmilola Wuraola, Akinbolaji Akinkuolie, Amarachukwu Etonyeaku, Arinzechukwu Mosanya, Omobolaji Ayandipo, Peter Elemile, Taiwo Akeem Lawal, Samuel Ali Sani, Stephen Garba, Rebecca Hauwa Sani, Samson Olori, Henry Onyebuashi, Ifeanyi Umoke, Adedire Adenuga, Ademola Adeyeye, Olufemi Habeeb, Bashir Lawal, Abdulrasheed Nasir, Eirik Kjus Aahlin, Didrik Kjønås, Elisabeth Myrseth, Jibran Abbasy, Abdul Alvi, Omair Saleem, Asma Afzal, Anam Nazir, Muhammad Farooq, Ayesha Liaqat, Syed Asghar Naqi, Ali Raza, Muzna Sarfraz, Muhammad Sarwar, Muntaha Banglani, Ambreen Munir, Rahmat Sehrish, Bushra Ayub, Raza Sayyed, Amna Altaf, Saima Ayub, Ahmad Uzair Qureshi, Komal Saeed, Bilal Syed, Sana Amir Akbar, Abdul Wahid Anwer, Ruqayya Naheed Khan, Amina Iqbal Khan, Shahid Khattak, Sameen Mohtasham, Muhammad Asad Parvaiz, Aamir Ali Syed, Abdul Basit Ansari, Noman Shahzad, Tanwir Khaliq, Isbah Rashid, Shahzad Hussain Waqar, Hasan Abu Al-Saleem, Amjad Abu Alqumboz, Mohammad Alqadi, Adham Amro, Rawan Assa, Eman Awesat, Rawan Ayyad, Mohammed Hammad, Ayat Haymony, Bassel Hijazi, Bara Hmeidat, Rowaa Lahaseh, Aseel Qawasmi, Alaa Rajabi, Mohammed Shehada, Sundus Shkokani, Yasmine Yaghi, Nadine Yaghi, Mohammad AlZohour, Mohammad Farid, Yousef Mahmoud Habes, Wesam Juba, Yanal Nubani, Abdelrahman Rabee, Mohammad Sa'deh, Saeed Abed, Iyad Al Basos, Mohammad Alswerki, Dina Ashour, Israa Awad, Samar Diab, Alaa El Jamassi, Sahar El-Kahlout, Somaya Elhout, Ahmed N K Hajjaj, Doaa Hasanain, Baraa Nabil Hajjaj, Mohammed Obaid, Eman Saikaly, Ahmed Salhi, Hiba Al-Tammam, Murad Almasri, Muath Baniowda, Doha Beshtawi, Ali Horoub, Rami Misk, Bayan Mohammad, Rami Qasrawi, Tasnim Sholi, Samar Abu-Nimeh, Abrar Abu-Srour, Sadi A Abukhalaf, Samer Adawi, Barah Alsalameh, Kholoud Ayesh, Muawiyah Elqadi, Ahmad Hammouri, Fatima Karim Mustafa, Natalie Marzouqa, Shatha Melhem, Dima Miqdad, Balqees Mohamad, Mhammed Rawhi, Ayman B Abu Ahammala, Ahmed Abu Ataya, Israa Abu Jayyab, Samar Al-Shwaikh, Othman Alagha, Mohammed Alasttal, Haneen Awadallah, Mahmood Elblbessy, Jehad Fares, Akram Jarbou, Ibtisam Mahfouz, Moath A Albahnasawi, Asmaa' Abo Mahadi, Hasan Abuelhatal, Ayham Abuelqomboz, Abdelrahman Almoqayyad, Abdallah Alwali, Reem Balaawi, Mahmoud Hamouda, Mohammed Humeid, Abdullah Jedyan, Tasneem Mahmoud Abu Hamam, Ghadeer Matar, Ali Salem, Tahani Samra, Nureddin Shaheen, Karam Shihada, Ayoob A Nemer, Mahmoud Abu Al Amrain, Abdulwhhab Abu Alamrain, Najlaa Abu Jamie, Mohammed R Abu-Rous, Nada Alfarra, Mohammed AlTaweel, Noor Alwhaidi, Ramadan Hamed, Bader Saqqa, Ahmad Shaheen, Dana Aljaber, Loay Aljaberi, Malak Alwaheidi, Assef Jawaada, Hani Khaldi, Rami Qahoush, Jalil Qari, Rana Saadeh, Ahlam Salim, Aseel Yacoub, Abbas Abbas, Rana Abu Shua'ib, Baraa Abu Zainah, Mahmoud AbuSirrees, Basheer Babaa, Ola Barhoush, Asef Belal Qadomi, Laith Daraghmeh, Reema Haji, Alaa Khatatbeh, Lana Khatib, Salsabeel Qarariah, Yara Quzmar, Khalil Safadi, Roqaya Salameh, Mohammad Hassan, Shifaa Herzallah, Loai Massad, Ahmed Nazzal, Ranin Nazzal, Dennis Escobar, Gustavo Miguel Machain V, Agustin Rodriguez Gonzalez, Jorge Emerson Chachaima Mar, Nathaly Olga Chinchihualpa Paredes, Vicente Cuba, Walter Lopez, Maria Milagros Niquen Jimenez, Nestor Alberto Sanchez Bartra, Olenka Sapallanay Ojeda, Diego Sequeiros, Andrea Toscano Pacheco, María Vergara, Sol Abarca, Rodrigo Alcorta, Giuliano Borda-Luque, Ivan Edward Eusebio Zegarra, Claudia Luján López, Mirella Marrufo, Cinthya Mogrovejo, Andrea Nomura, Yamile Rodríguez Angeles, Maitza Rosario Vidal Meza, Gabriela Zavala, José Neiser Castillo Arrascue, Jomara Caroline Hidrogo Cabrera, José Julio Mariano Larrea Vera, Miguel Osorio, Edgar Alcides Ylatoma Díaz, Mark Anthony Fontanilla, Joseph Roy Fuentes, Anna Leah Salazar, Genieve Dominguez, Marc Paul Lopez, Shiela Macalindong, Mark Augustine Onglao, Arjel Ramirez, Marie Dione Sacdalan, Mayou Martin Tampo, Gemma Leonora Uy, Jeremiah Mangahas, Kenneth Yabut, Joannes Paul Cañete, Bernalynn Eris Cansana, Ernes John Castro, Maria Kaiserin Lipana, Manuel Francisco Roxas, Vlu Jean Zara, Maciej Chroł, Paula Franczak, Michał Orłowski, Piotr Budzyński, Andrzej Budzyński, Pawel Bury, Agata Czerwińska, Jadwiga Dworak, Jacek Dziedzic, Michał Kisielewski, Jan Kulawik, Anna Lasek, Piotr Major, Piotr Małczak, Marcin Migaczewski, Michał Pędziwiatr, Magdalena Pisarska, Dorota Radkowiak, Mateusz Rubinkiewicz, Anna Rzepa, Tomasz Skoczylas, Maciej Stanek, Katarzyna Truszkiewicz, Mateusz Wierdak, Marek Winiarski, Piotr Zarzycki, Anna Zub-Pokrowiecka, Piotr Kowalewski, Rafał Roszkowski, Maciej Walędziak, Miguel Tomé, Sara Patrocinio, Ines Guerreiro, Filipe Almeida, Xavier de Sousa, Nuno Monteiro, Maria Teresa Costa Santos, Daniela de Oliveira, Marta Lopes Serra, Daniela Morgado, Christian Neves, Ana Carolina Oliveira, Alice Pimentel, Sofia Silva, Márcia Carvalho, Lúcia Carvalho, Joana Magalhães, Leonor Matos, Tânia Monteiro, Carlota Ramos, Vanessa Santos, José Barbosa, Jose Costa-Maia, Vítor Devezas, Ana Fareleira, Cristina Fernandes, Diana Gonçalves, Henrique Mora, Marina Morais, Fabiana Silva de Sousa, Sara Catarino Santos, Ana Logrado, André Tojal, Edgar Amorim, Miguel F Cunha, Ana Fazenda, João Pedro Melo Neves, Inês Isabel Sampaio da Nóvoa Gomes Miguel, Diogo Veiga, José Azevedo, Hugo Cardoso Louro, Mariana Leite, José Azevedo, Maria Bairos Menezes, Bárbara Gama, Diana Brito, Marta Cristina Cruz Martins, André Graça E Magalhães, Ana Catarina Longras, Rita Lourenço, Diana Matos, Luis Castro, Filipa Policarpo, Joana Romano, Mariana Leite, Cristina Monteiro, Diogo Pinto, Marina Duarte, Sónia Fortuna Martins, Mariline Oliveira, Diogo Galvão, Lisandra Martins, Anaisa Silva, Viorel Taranu, Bárbara Vieira, Jessica Neves, Simone Oliveira, Hugo Ribeiro, Margarida Cinza, Rosa Felix, Arnaldo Machado, Joana Oliveira, Joana Patrício, Rita Pedroso de Lima, Mário Pereira, Miguel Rocha Melo, Cristina Velez, Alberto Abreu da Silva, Mariana Claro, Daniel Costa Santos, Andreia Ferreira, Hugo Capote, Daniela Rosado, Filipa Taré, Oriana Nogueira, Miguel Ângelo, José Miguel Baiao, Andreia Guimarães, João Marques, Miguel Nico Albano, Marta Silva, Ana Valente da Costa, Teresa Vieira Caroço, Sara Almeida Braga, Ines Capunge, Marta Fragoso, João Guimarães, Bruno Pinto, João Ribeiro, Miguel Angel, Guilherme Fialho, Monica Guerrero, Filipa Campos Costa, Diogo Cardoso, Vasco Cardoso, Magda Alves, Inês Estalagem, Tiago Louro, Cláudia Marques, Rita Martelo, Miguel Morgado, Rita Canotilho, Ana Margarida Correia, Pedro Martins, Mariana Peyroteo, João Gomes, Rita Monteiro, Manuela Romano, Daniela Macedo Alves, Rita Peixoto, Catarina Quintela, Maria João Jervis, Débora Melo, André Pacheco, Valter Paixão, Vera Pedro, Joana Pimenta, João Pimenta de Castro, Ana Rocha, Mircea Beuran, Matei Razvan Bratu, Cezar Ciubotaru, Bogdan Diaconescu, Sorin Hostiuc, Ionut Negoi, Bogdan Stoica, Evgeny Anokhin, Georgy Kuznetsov, Giorgi Oganezov, Fedor Paramzin, Ekaterina Romanova, Valeryan Rutkovskii, Vasilii Rutkovskii, Mikhail Shushval, Mikhail Zabiyaka, Khasan Dzhumabaev, Valerii Ivanov, Zaman Mamedli, Sergey Achkasov, Artem Balkarov, Elnur Nabiev, Marat Nagudov, Evgeny Rybakov, Karina Saifutdinova, Oleg Sushkov, Armen Vardanyan, Ainhoa Costas-Chavarri, Lule Joseph, Isaac Ndayishimiye, J C Allen Ingabire, Ntirenganya Faustin, Alphonse Zeta Mutabazi, Jean Paul Mvukiyehe, Vizir J P Nsengimana, Carine Uwakunda, Mohammad Monir Abbas, Nouf Akeel, Murad Aljiffry, Kholoud Awaji, Ali Farsi, Ghader Jamjoum, Ahmad Khoja, Ashraf Maghrabi, Nadim Malibary, Mohammed Nassif, Abdulaziz Saleem, Abdullah Sultan, Wail Tashkandi, Hanaa Tashkandi, Nora Trabulsi, Mouhamadou Bachir Ba, Adja Coumba Diallo, Abdourahmane Ndong, Vladica Cuk, Uroš Janković, Jovan Juloski, Sharon Zhiling Koh, Frederick Koh, Kuok Chung Lee, Kai Yin Lee, Sean Lee, Wei Qi Leong, Bettina Lieske, Su Ann Lui, Prajwala Prakash, Jan Grosek, Gregor Norcic, Ales Tomazic, Nicolas Fitchat, Robert Jaich, Devorah Wineberg, Modise Zacharia Koto, Daniella Baiocchi, Damian Clarke, Christina Johanna Steenkamp, Stephanie Van Straten, Sharon Bannister, Adam Boutall, Galya Chinnery, Anna Coccia, Angela Dell, Parveen Karjiker, Christo Kloppers, Nicholas Loxton, Tumi Mabogoane, Francois Malherbe, Eugenio Panieri, Shreya Rayamajhi, Richard Spence, Tirsa van Wyngaard, Claire Warden, T E Madiba, Yoshan Moodley, Nivashen Pillay, Savannah Brooks, Charlise Kruger, Lisa Hannah Van Der Merwe, Ferhana Gool, Maahir Kariem, Heather Bougard, Kathryn Chu, Nazmie Kariem, Fazlin Noor, Reantha Pillay, Leandi Steynfaardt, Lucía González González, José Miguel Marín Santos, Paula Martín-Borregón, Javier Martínez Caballero, Cristina Nevado García, Pastora Rodriguez Fraga, Gonzalo De Castro Parga, Maria Pilar Fernández Veiga, Lucía Garrido López, Hugo Infante Pino, Irene Lages Cal, Marta López Otero, Manuel Nogueira Sixto, Marta Paniagua García Señorans, Laura Rodríguez Fernández, Alejandro Ruano Poblador, Erika Rufo Crespo, Raquel Sanchez-Santos, Vincenzo Vigorita, Ester Alonso Batanero, Dorisme Asnel, Isabel Cifrian Canales, Elisa Contreras Saiz, Irene De Santiago Alvarez, Tamara Díaz Vico, Sebastian Fernandez Arias, Daniel Fernández Martínez, Carmen García Bernardo, Luis Joaquín García Flórez, Carmen Garcia Gutierrez, Manuel García Munar, Carlos Alberto Márquez Zorrilla Molina, Marta Merayo, José Luis Michi Campos, Maria Moreno Gijon, Jorge L Otero-Diez, Jose Luis Rodicio Miravalles, Lorena Solar-Garcia, Aida Suárez Sánchez, Nuria Truan, Cristina Alejandre 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W., Santos Bezerra, T., Gribnev, P., Dimitrov, D., Krastev, P., Oum, S., Bonghaseh, D. T., Al Farsi, M., Alsharqawi, N., Acevedo, V., Castillo Barbosa, A. C., Giron, F., Leon Rodriguez, J. P., Kucan, D., Rosko, D., Barsic, N., Zupan, D., Hegazi, A., Truncikova, V., Fryba, V., Mohamed, M., Nagi, A., Rashad Temerik, A., Elshawy, M. E., Mahmoud, M. I., Anwar, M., Rageh, T., Elmokadem, A., Gaballa, K., Teppo, S., Pengerma, P., Ballouhey, Q., Bergeat, D., Weyl, A., Hain, E., Gyedu, A., Yenli, E., Osei-Poku, D., Rompou, V. -A., Zoikas, A., Gaitanidis, A., Koukis, G., Perivoliotis, K., Tavlas, P., Galanos-Demiris, K., Zografos, G., Karavokyros, I., Xanthopoulou, G., Iordanidou, E., Ayau, F., Garcia, A., Damjan, P., Wason, D., B L, A., Rangganata, E., Kamath, P., O'Connor, D. B., Pinto, M., Perrone, F., Tropeano, F. P., Troilo, F., Bossi, D., Scala, D., Pulitano, L., Carella, M., Pietrabissa, A., Gori, A., Giraudo, G., De Simone, V., Russo, A. A., Braccio, B., Al-Taher, R., Athamneh, S., Parker, A., Sawiee, A., Kattia, A., Tababa, O., Shaeeb, Z., Syminas, V., Jurgaitis, J., Damuleviciene, G., Svagzdys, S., Razafimanjato, N. N. M., Chieng Loo, L., Tiong, I. C., Wan Muhmad, W. F., Vijeyan, H., Li Ying, T., Grech, G., Arrangoiz, R., Jimenez Ley, V. B., Arizpe, D., Lagunes Lara, E., Castro Lopez, E. V., Eaazim, J., Gordinou de Gouberville, M., Bastiaenen, V., Rottier, S., Nahab, F., Ji, M. Y., Seyoji, M., Nwachukwu, C., Emeghara, O., Muhammed, S. E., Idowu, A., Sowemimo, O., Ogundoyin, O., Akande, O., Lott, A., Nadeem, M., Laghari, A. A., Loya, A., Mushtaq, H., Abdullah, M. T., Abuhilal, B., Atawneh, M., Hamdan, H., Alhabil, B., Srour, A., Mousa, I., Da Silva Medina, L., Bartosiak, K., Ferreira, P., Francisco, V., Lemos, R., Frutuoso, L., Fernandes, S., Fonseca, T., Pereira, J., Rachadell, J., Torre, A., Madeira Martins, F., Carvalho, A. 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M., Srinivas, A., Sung, C. -Y., Tai, A., Valle Aranda, Y. C., Venturini, S., Wilguens Lartigue, J., Public and occupational health, AMS - Sports, APH - Health Behaviors & Chronic Diseases, CCA - Cancer Treatment and quality of life, Amsterdam Gastroenterology Endocrinology Metabolism, Cancer Center Amsterdam, and Albarella, Sara

Subjects
global surgery, hospitals, humans, income, neoplasms, postoperative period, poverty, prospective studies, no keywords listed, General Medicine, Prospective Studie, Hospital, Settore MED/18 - Chirurgia Generale, outcome, Hospitals, Humans, Income, Neoplasms, surgery, Postoperative Period, Poverty, Prospective Studies, cancer surgery, Human, hospital facilities
Abstract

© 2022 The Author(s). Published by Elsevier Ltd. This is an Open Access article under the CC BY 4.0 licenseBackground: Early death after cancer surgery is higher in low-income and middle-income countries (LMICs) compared with in high-income countries, yet the impact of facility characteristics on early postoperative outcomes is unknown. The aim of this study was to examine the association between hospital infrastructure, resource availability, and processes on early outcomes after cancer surgery worldwide. Methods: A multimethods analysis was performed as part of the GlobalSurg 3 study—a multicentre, international, prospective cohort study of patients who had surgery for breast, colorectal, or gastric cancer. The primary outcomes were 30-day mortality and 30-day major complication rates. Potentially beneficial hospital facilities were identified by variable selection to select those associated with 30-day mortality. Adjusted outcomes were determined using generalised estimating equations to account for patient characteristics and country-income group, with population stratification by hospital. Findings: Between April 1, 2018, and April 23, 2019, facility-level data were collected for 9685 patients across 238 hospitals in 66 countries (91 hospitals in 20 high-income countries; 57 hospitals in 19 upper-middle-income countries; and 90 hospitals in 27 low-income to lower-middle-income countries). The availability of five hospital facilities was inversely associated with mortality: ultrasound, CT scanner, critical care unit, opioid analgesia, and oncologist. After adjustment for case-mix and country income group, hospitals with three or fewer of these facilities (62 hospitals, 1294 patients) had higher mortality compared with those with four or five (adjusted odds ratio [OR] 3·85 [95% CI 2·58–5·75]; p

Published
2022

40. Immunoglobulin and T Cell Receptor Gene High-Throughput Sequencing Quantifies Minimal Residual Disease in Acute Lymphoblastic Leukemia and Predicts Post-Transplantation Relapse and Survival

Author

Logan, Aaron C, Vashi, Nikita, Faham, Malek, Carlton, Victoria, Kong, Katherine, Buño, Ismael, Zheng, Jianbiao, Moorhead, Martin, Klinger, Mark, Zhang, Bing, Waqar, Amna, Zehnder, James L, and Miklos, David B

Subjects
Biomedical and Clinical Sciences, Cardiovascular Medicine and Haematology, Genetics, Cancer, Regenerative Medicine, Hematology, Childhood Leukemia, Pediatric Cancer, Rare Diseases, Pediatric, Clinical Research, Transplantation, Adolescent, Adult, Aged, Genes, T-Cell Receptor, Hematopoietic Stem Cell Transplantation, High-Throughput Nucleotide Sequencing, Humans, Immunoglobulins, Middle Aged, Neoplasm Recurrence, Local, Neoplasm, Residual, Precursor Cell Lymphoblastic Leukemia-Lymphoma, Prognosis, Retrospective Studies, Survival Analysis, Transplantation Conditioning, Transplantation, Homologous, Young Adult, Acute lymphoblastic leukemia, Minimal residual disease, Allogeneic hematopoietic cell transplantation, High-throughput sequencing, Next-generation sequencing, Clinical Sciences, Immunology, Cardiovascular medicine and haematology
Abstract

Minimal residual disease (MRD) quantification is an important predictor of outcome after treatment for acute lymphoblastic leukemia (ALL). Bone marrow ALL burden ≥ 10(-4) after induction predicts subsequent relapse. Likewise, MRD ≥ 10(-4) in bone marrow before initiation of conditioning for allogeneic (allo) hematopoietic cell transplantation (HCT) predicts transplantation failure. Current methods for MRD quantification in ALL are not sufficiently sensitive for use with peripheral blood specimens and have not been broadly implemented in the management of adults with ALL. Consensus-primed immunoglobulin (Ig), T cell receptor (TCR) amplification and high-throughput sequencing (HTS) permit use of a standardized algorithm for all patients and can detect leukemia at 10(-6) or lower. We applied the LymphoSIGHT HTS platform (Sequenta Inc., South San Francisco, CA) to quantification of MRD in 237 samples from 29 adult B cell ALL patients before and after allo-HCT. Using primers for the IGH-VDJ, IGH-DJ, IGK, TCRB, TCRD, and TCRG loci, MRD could be quantified in 93% of patients. Leukemia-associated clonotypes at these loci were identified in 52%, 28%, 10%, 35%, 28%, and 41% of patients, respectively. MRD ≥ 10(-4) before HCT conditioning predicted post-HCT relapse (hazard ratio [HR], 7.7; 95% confidence interval [CI], 2.0 to 30; P = .003). In post-HCT blood samples, MRD ≥10(-6) had 100% positive predictive value for relapse with median lead time of 89 days (HR, 14; 95% CI, 4.7 to 44, P

Published
2014

41. Improved Survival with T Cell Clonotype Stability After Anti–CTLA-4 Treatment in Cancer Patients

Author

Cha, Edward, Klinger, Mark, Hou, Yafei, Cummings, Craig, Ribas, Antoni, Faham, Malek, and Fong, Lawrence

Subjects
Clinical Research, Cancer, Antibodies, Monoclonal, CTLA-4 Antigen, Humans, Neoplasms, Survival Analysis, Biological Sciences, Medical and Health Sciences
Abstract

Cytotoxic T lymphocyte-associated antigen-4 (CTLA-4) blockade can promote antitumor T cell immunity and clinical responses. The mechanism by which anti-CTLA-4 antibodies induces antitumor responses is controversial. To determine the effects of CTLA-4 blockade on the T cell repertoire, we used next-generation deep sequencing to measure the frequency of individual rearranged T cell receptor β (TCRβ) genes, thereby characterizing the diversity of rearrangements, known as T cell clonotypes. CTLA-4 blockade in patients with metastatic castration-resistant prostate cancer and metastatic melanoma resulted in both expansion and loss of T cell clonotypes, consistent with a global turnover of the T cell repertoire. Overall, this treatment increased TCR diversity as reflected in the number of unique TCR clonotypes. The repertoire of clonotypes continued to evolve over subsequent months of treatment. Whereas the number of clonotypes that increased with treatment was not associated with clinical outcome, improved overall survival was associated with maintenance of high-frequency clones at baseline. In contrast, the highest-frequency clonotypes fell with treatment in patients with short overall survival. Stably maintained clonotypes included T cells having high-avidity TCR such as virus-reactive T cells. Together, these results suggest that CTLA-4 blockade induces T cell repertoire evolution and diversification. Moreover, improved clinical outcomes are associated with less clonotype loss, consistent with the maintenance of high-frequency TCR clonotypes during treatment. These clones may represent the presence of preexisting high-avidity T cells that may be relevant in the antitumor response.

Published
2014

42. The influence of Apolipoprotein E genotype on regional pathology in Alzheimer’s disease

Author

Sabbagh, Marwan N, Malek-Ahmadi, Michael, Dugger, Brittany N, Lee, Katarina, Sue, Lucia I, Serrano, Geidy, Walker, Douglas G, Davis, Kathryn, Jacobson, Sandra A, and Beach, Thomas G

Subjects
Biomedical and Clinical Sciences, Neurosciences, Clinical Sciences, Alzheimer's Disease including Alzheimer's Disease Related Dementias (AD/ADRD), Brain Disorders, Alzheimer's Disease, Aging, Neurodegenerative, Acquired Cognitive Impairment, Dementia, Genetics, Aetiology, 2.1 Biological and endogenous factors, Neurological, Aged, Aged, 80 and over, Alzheimer Disease, Apolipoprotein E4, Brain, Female, Genotype, Humans, Male, Neurofibrillary Tangles, Retrospective Studies, Statistics, Nonparametric, Cognitive Sciences, Neurology & Neurosurgery, Clinical sciences
Abstract

BackgroundCarriers of the ApoE ϵ4 allele are at a greater risk for developing Alzheimer's disease (AD) and those who do develop AD tend to have a much greater neuropathological disease burden. Although several studies have shown significant differences in AD pathology among ϵ4 carriers and non-carriers, few have characterized these differences in terms of brain region and neuropathological score frequency.Methods566 pathologically-confirmed AD cases who were followed prospectively with antemortem dementia diagnoses (312 ApoE ϵ4 carriers and 254 ApoE ϵ4 non-carriers) were compared on the frequencies of neuropathological frequency scores (none, sparse, moderate, frequent) among several different brain regions (frontal, temporal, parietal, hippocampal, and entorhinal) using the CERAD scoring system. Pathology score frequencies were analyzed by carrier status (ϵ4 carrier vs. ϵ4 non-carrier) and by genotype (2/3, 3/3, 2/4, 3/4, 4/4). Both analyses investigated pathology score frequencies among different brain regions (frontal, temporal, parietal, hippocampal, and entorhinal).Resultsϵ4 carriers had a significantly lower age at death (p

Published
2013

43. Association of longitudinal cognitive decline with diffusion MRI in Gray Matter, Amyloid, and Tau deposition

Author

Wei-En, Wang, Rob, Chen, Robin Perry, Mayrand, Malek, Adjouadi, Ruogu, Fang, Steven T, DeKosky, Ranjan, Duara, Stephen A, Coombes, and David E, Vaillancourt

Subjects
Amyloid, Aging, Amyloid beta-Peptides, General Neuroscience, Water, tau Proteins, Amyloidogenic Proteins, Amyloidosis, Cross-Sectional Studies, Diffusion Magnetic Resonance Imaging, Alzheimer Disease, Humans, Cognitive Dysfunction, Neurology (clinical), Gray Matter, Geriatrics and Gerontology, Biomarkers, Developmental Biology
Abstract

Extracellular amyloid plaques in gray matter are the earliest pathological marker for Alzheimer's disease (AD), followed by abnormal tau protein accumulation. The link between diffusion changes in gray matter, amyloid and tau pathology, and cognitive decline is not well understood. We first performed cross-sectional analyses on T1-weighted imaging, diffusion MRI, and amyloid and tau PETs from the ADNI 2/3 database. We evaluated cortical volume, free-water, fractional anisotropy (FA), and amyloid and tau SUVRs in 171 cognitively normal, 103 MCI, and 44 AD individuals. When the 3 groups were combined, increasing amyloid burden was associated with reduced extracellular free-water in the entorhinal cortex and hippocampus in those with amyloid-negative status whereas increasing tau burden was associated with increased extracellular free-water regardless of amyloid status. Next, we found that for the MCI subjects, diffusion measures (free-water, FA) alone predicted MMSE score 2 years later with a high r-square value (87%), as compared to tau SUVRs (27%), T1 volume (36%), and amyloid SUVRs (75%). Diffusion measures represent a potent non-invasive marker for predicting cognitive decline.

Published
2023

45. Analysis of molecular inversion probe performance for allele copy number determination

Author

Wang, Yuker, Moorhead, Martin, Karlin-Neumann, George, Wang, Nicholas J, Ireland, James, Lin, Steven, Chen, Chunnuan, Heiser, Laura M, Chin, Koei, Esserman, Laura, Gray, Joe W, Spellman, Paul T, and Faham, Malek

Subjects
Biological Sciences, Genetics, Biotechnology, Alleles, Cell Line, Tumor, Chromosome Aberrations, Chromosome Inversion, False Positive Reactions, Humans, Loss of Heterozygosity, Molecular Probes, Polymerase Chain Reaction, ROC Curve, Environmental Sciences, Information and Computing Sciences, Bioinformatics
Abstract

We have developed a new protocol for using molecular inversion probes to accurately and specifically measure allele copy number. The new protocol provides for significant improvements, including the reduction of input DNA (from 2 mug) by more than 25-fold (to 75 ng total genomic DNA), higher overall precision resulting in one order of magnitude lower false positive rate, and greater dynamic range with accurate absolute copy number up to 60 copies.

Published
2007

46. Mechanisms of COVID-19-induced cerebellitis

Author

Mohammad Banazadeh, Sepehr Olangian-Tehrani, Melika Sharifi, Mohammadreza Malek-Ahmadi, Farhad Nikzad, Nooria Doozandeh-Nargesi, Alireza Mohammadi, Gary J. Stephens, and Mohammad Shabani

Subjects
SARS-CoV-2, Humans, COVID-19, RNA, Viral, Ataxia, General Medicine, Pandemics
Abstract

The COVID-19 pandemic caused by SARS-CoV2 has raised several important health concerns, not least increased mortality and morbidity. SARS-CoV2 can infect the central nervous system

Published
2022

47. An Assessment of Diversity, Inclusion, and Health Equity Training in Endocrinology Fellowship Programs in the United States

Author

Rana Malek, Amal Shibli-Rahhal, Ricardo Correa, Emily D. Szmuilowicz, Farah Morgan, Pooja Luthra, Imali Sirisena, Andrew Gianoukakis, Stephanie Smooke Praw, David C. Lieb, Jeehea Sonya Haw, and Sarah E. Mayson

Subjects
Male, Cross-Sectional Studies, Endocrinology, Health Equity, Education, Medical, Graduate, Surveys and Questionnaires, Endocrinology, Diabetes and Metabolism, Humans, Gender Identity, Female, Curriculum, Fellowships and Scholarships, United States
Abstract

The Accreditation Council for Graduate Medical Education has instituted common program requirements related to diversity, equity, and inclusion (DEI) for postgraduate trainees in the United States; however, the extent to which DEI training is being incorporated across endocrinology fellowship programs is unknown.To describe the sociodemographic representation and DEI training experiences within endocrinology fellowship programs.National cross-sectional survey study of fellows and fellowship program leaders in the United States whose fellowships were members of the Association of Program Directors in Endocrinology and Metabolism.(1) Demographics of fellows and program leaders and (2) programs' experience, confidence, and interest in formal DEI training.A total of 108 and 106 fellow and faculty responded to the survey, respectively. The majority of fellows and faculty are female. Less than 3% of fellows and 3.7% of faculty identify as Black. More than 90% of fellows/faculty are heterosexual and no respondents identified as transgender/nonbinary; however, 5% and 2% of all respondents preferred not to disclose their sexual orientation and gender identity, respectively. While 85% of faculty received institutional diversity and inclusion training, 67.6% of fellows did. Fellows are more likely to have received training in health equity than program leaders. Both fellows and program leaders express a high interest in health equity curriculum.Within the diversity of endocrinology training programs, Black physicians are underrepresented in medicine, which persists in endocrinology fellowships. Fellowship programs express enthusiasm for national diversity and health equity curricula, with the majority of programs reporting institutional DEI training.

Published
2022

48. Anti-Saccharomyces cerevisiae antibodies in patients with COVID-19

Author

Sarra, Melayah, Amani, Mankaï, Malek, Jemni, Arij Ben, Chaben, Mariam, Ghozzi, Asma, Ben Abdelkrim, Kousay, Ach, Nadia, Ghariani, Mohamed, Denguezli, Wafa, Benzarti, Mohamed, Benzarti, Salma, Melayah, Walid, Naija, and Ibtissem, Ghedira

Subjects
Acquired Immunodeficiency Syndrome, Immunoglobulin G, Gastroenterology, Humans, COVID-19
Abstract

Anti-Saccharomyces cerevisiae antibodies (ASCA) have been described in many autoimmune diseases (AIDs). Coronavirus disease 2019 (COVID-19) could trigger AIDs. This study aimed to determine the frequency of ASCA in patients with COVID-19.This study included 88 adult patients with severe COVID-19, 51 mild COVID-19, and 160 healthy blood donors. ASCA of isotype immunoglobulin (Ig)G and IgA were detected by enzyme-linked immunosorbent assay.The frequency of ASCA (IgG or IgA) was significantly higher in patients with severe COVID-19 (21.6 % vs 3.7 %, p 10ASCA was more frequent in patients with COVID-19 than in healthy controls.

Published
2022

49. Anticoagulation and Antiplatelet Therapy for Prevention of Venous and Arterial Thrombotic Events in Critically Ill Patients With COVID-19: COVID-PACT

Author

Erin A. Bohula, David D. Berg, Mathew S. Lopes, Jean M. Connors, Ijlal Babar, Christopher F. Barnett, Sunit-Preet Chaudhry, Amit Chopra, Wilson Ginete, Michael H. Ieong, Jason N. Katz, Edy Y. Kim, Julia F. Kuder, Emilio Mazza, Dalton McLean, Jarrod M. Mosier, Ari Moskowitz, Sabina A. Murphy, Michelle L. O’Donoghue, Jeong-Gun Park, Rajnish Prasad, Christian T. Ruff, Mohamad N. Shahrour, Shashank S. Sinha, Stephen D. Wiviott, Sean Van Diepen, Mark Zainea, Vivian Baird-Zars, Marc S. Sabatine, David A. Morrow, Kyung Ah Im, Retu Saxena, Brandon Wiley, Carina Benson, Roman Delamed, Nedaa Skeik, Ami Chopra, Marc Judson, Scott Beegle, Boris Shkolnik, Anupama Tiwari, Gregory Wu, Abhijit Raval, Emerald Branch, Franz Rischard, Cameron Hypes, Billie Bixby, Christian Bime, Madhan Sundaram, Nancy Sweitzer, Alfredo Vazquez Sandoval, Heath White, Katherine Berg, Shahzad Shaefi, Michael Donnino, Brett Carroll, Michael Ieong, Kimberly Ackerbauer, Jaime Murphy, Ankeet Bhatt, Alexander Blood, Siddharth Patel, Victor Luu, Shraddha Narechania, Austin Lorganger, Robert Plambeck, Ali Nayfeh, Michael Sanley, Michel Del Cor, AJ Hegg, Winston Nara, Michael Snyder, Faisal Khan, Imad Shawa, Joshua Larned, Elias Collado, Mohammed Al Faiyumi, Rajeev Mehta, Sudarshan Komanapalli, Vijayadershan Muppidi, Mehul Desai, Casey Flanagan, Leonard Genovese, Tariq Haddad, Christopher King, Amber Peterson, Thane Htun, Elizabeth Pionk, Nicolas Mouawad, Chintalapudi Kumar, Kevin Nguyen, Majid Mughal, Ryan Malek, Akarsh Parekh, Christopher Provenzano, Melissa Ianitelli, Nicole Prentice-Gaytan, Adam Bykowski, Don Tait, Shelley Schendel, Varun Yalamanchili, Vasim Lala, Victor Hunyadi, Alexander Papolos, Benjamin Kenigsberg, Aarthi Shenoy, Thomas Stuckey, Douglas McQuaid, Praveen Mannam, Jeffrey McClung, Kent Nilsson, Andrew McKown, Jason Wells, David Hotchkin, Marc Jacobs, Wayne Strauss, Rick Balestra, Vikram Sahni, R. Jeffrey Snell, Hussam Suradi, Sarah Sungurlu, Jessica Kuppy, Eileen Gajo, Foster Adams, Abbas Shehadeh, Addi Suleiman, Harish Nandigam, Jihad Slim, Sardar Ijlal Babar, Dipti Baral, Talha Nawaz, Syed Abdullah Waheed, Randy Roth, Subhas Sitaula, Shahid Hayat, Jooby Babu, Jason Caberto, Victor Hsu, Robert Chang, Markian Bochan, Rafael Garcia-Cortes, Hal Skopicki, On Chen, Lauren Pilato, Paul Richman, Alexander Adler, Praveen Sudhindra, Jamie Beversdorf, Ravindra Kashyap, Parth Mehta, Borna Mehrad, Ali Ataya, Jorge Lascano, Mark Brantly, Adam Austin, Eduard Koman, Thomas Galski, Vijaya Kumar, Ayman Soubani, Nicolas Harrison, Vineet Reddy, and Audrey Fonkam

Subjects
Venous Thrombosis, Treatment Outcome, Critical Illness, Physiology (medical), Humans, COVID-19, Anticoagulants, Thrombosis, Hemorrhage, Cardiology and Cardiovascular Medicine, Platelet Aggregation Inhibitors, Clopidogrel
Abstract

Background: The efficacy and safety of prophylactic full-dose anticoagulation and antiplatelet therapy in critically ill COVID-19 patients remain uncertain. Methods: COVID-PACT (Prevention of Arteriovenous Thrombotic Events in Critically-ill COVID-19 Patients Trial) was a multicenter, 2×2 factorial, open-label, randomized-controlled trial with blinded end point adjudication in intensive care unit–level patients with COVID-19. Patients were randomly assigned to a strategy of full-dose anticoagulation or standard-dose prophylactic anticoagulation. Absent an indication for antiplatelet therapy, patients were additionally randomly assigned to either clopidogrel or no antiplatelet therapy. The primary efficacy outcome was the hierarchical composite of death attributable to venous or arterial thrombosis, pulmonary embolism, clinically evident deep venous thrombosis, type 1 myocardial infarction, ischemic stroke, systemic embolic event or acute limb ischemia, or clinically silent deep venous thrombosis, through hospital discharge or 28 days. The primary efficacy analyses included an unmatched win ratio and time-to-first event analysis while patients were on treatment. The primary safety outcome was fatal or life-threatening bleeding. The secondary safety outcome was moderate to severe bleeding. Recruitment was stopped early in March 2022 (≈50% planned recruitment) because of waning intensive care unit–level COVID-19 rates. Results: At 34 centers in the United States, 390 patients were randomly assigned between anticoagulation strategies and 292 between antiplatelet strategies (382 and 290 in the on-treatment analyses). At randomization, 99% of patients required advanced respiratory therapy, including 15% requiring invasive mechanical ventilation; 40% required invasive ventilation during hospitalization. Comparing anticoagulation strategies, a greater proportion of wins occurred with full-dose anticoagulation (12.3%) versus standard-dose prophylactic anticoagulation (6.4%; win ratio, 1.95 [95% CI, 1.08–3.55]; P =0.028). Results were consistent in time-to-event analysis for the primary efficacy end point (full-dose versus standard-dose incidence 19/191 [9.9%] versus 29/191 [15.2%]; hazard ratio, 0.56 [95% CI, 0.32–0.99]; P =0.046). The primary safety end point occurred in 4 (2.1%) on full dose and in 1 (0.5%) on standard dose ( P =0.19); the secondary safety end point occurred in 15 (7.9%) versus 1 (0.5%; P =0.002). There was no difference in all-cause mortality (hazard ratio, 0.91 [95% CI, 0.56–1.48]; P =0.70). There were no differences in the primary efficacy or safety end points with clopidogrel versus no antiplatelet therapy. Conclusions: In critically ill patients with COVID-19, full-dose anticoagulation, but not clopidogrel, reduced thrombotic complications with an increase in bleeding, driven primarily by transfusions in hemodynamically stable patients, and no apparent excess in mortality. Registration: URL: https://www.clinicaltrials.gov ; Unique identifier: NCT04409834.

Published
2022

50. Size matters – From the working channel to the wavelength of light: Optimizing visualization in endoscopic spine surgery

Author

Roberto J. Perez-Roman, Gregory W. Basil, James V. Boddu, Malek Bashti, and Michael Y. Wang

Subjects
Endoscopes, Neurology, Physiology (medical), Humans, Minimally Invasive Surgical Procedures, Endoscopy, Surgery, Neurology (clinical), General Medicine, Spine
Abstract

Minimally invasive surgery bases many of its benefits on decreasing tissue disruption. Endoscopic spine surgery has continued to push the boundaries to accomplish successful clinical outcomes through the evolution of the endoscope and working channel. As the indications for endoscopic spine surgery increase, a more profound discussion of cannula size selection for endoscopic spine surgery is required. The intimate relationship between the working channel, the endoscope and how these choices affect workflow and visualization are paramount to maximize outcomes.The authors review the nuances of the endoscopic approaches to the various regions of the spine as it relates to the selection of the working channel. The advantages and limitations of various endoscopic working channels were analyzed as to how they address anatomic regional considerations as well as ultimate goals of surgery.In addition to anatomic regional differences and the goals of the surgery other key elements in endoscopic working channel selection included the amount of tissue disruption, regional risk to the neural elements, impact on visualization, optical physics, and the implications for surgical maneuverability/dexterity.Understanding the role and use of the endoscope-working channel combination with its effects on visualization is essential for any surgeon aspiring to perform safe and efficient full endoscopic spine surgery.

Published
2022

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