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51. Optimizing multiple process parameters in fused deposition modeling with particle swarm optimization

Author: Arup Dey, David Hoffman, and Nita Yodo
Subjects: 0209 industrial biotechnology, Fused deposition modeling, Computer science, Orientation (computer vision), business.industry, Process (computing), Particle swarm optimization, 02 engineering and technology, 021001 nanoscience & nanotechnology, Industrial and Manufacturing Engineering, law.invention, 020901 industrial engineering & automation, Compressive strength, law, Industrial design, Modeling and Simulation, Extrusion, 0210 nano-technology, Process engineering, business, Engineering design process
Abstract: Fused deposition modeling (FDM) is one of the most widely used additive manufacturing processes to produce prototypes as well as functional parts from thermoplastics. However, the applications of the FDM process are still limited due to several drawbacks, such as poor surface quality, poor mechanical properties, or high built time. It has been deemed that the part characteristics and build time can be improved by determining an optimum combination of process parameters. To optimize multiple process parameters in FDM, this paper employs a multi-objective particle swarm optimization based on the data collected from the experimental study. Four (04) process parameters, namely layer thickness, build orientation, infill density, and extrusion temperature are optimized to achieve higher compressive strength and lower build time. The optimization results provide information on the combined impacts of the four process parameters on compressive strength and build time. This information can aid decision makers with better judgment when dealing with multiple conflicting objectives.
Published: 2019
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52. For Homeless People with Serious Mental Illness, Can a State Transitional Shelter Promote Racial Equity in Housing Outcomes?

Author: Janet Marsden, Derri L. Shtasel, Corinne Cather, Kevin Potter, Kristina Schnitzer, Hawa Kaba, and David Hoffman
Subjects: Mental Health Services, medicine.medical_specialty, business.industry, Substance-Related Disorders, Mental Disorders, Housing status, Public Health, Environmental and Occupational Health, Mental illness, medicine.disease, Mental health, Substance abuse, Race (biology), Chart review, Psychiatric diagnosis, Ill-Housed Persons, medicine, Housing, Humans, business, Psychiatry, Racial equity, Retrospective Studies
Abstract: Objective To examine the role of race, sex, arrest history, and psychiatric diagnoses in duration of shelter tenure and housing outcomes for patients in transitional shelters. Methods The authors performed a three-year retrospective chart review of Massachusetts Department of Mental Health (DMH) records for individuals residing in three DMH transitional homeless shelters from 2013 to 2015. Results Race was not predictive of length of stay, initial disposition, or housing status at three to five-year follow-up. Arrest history negatively predicted initial housing placement, and diagnosis of substance use disorder predicted homelessness at follow-up. There were no differences by race in arrest history or diagnosis of substance use disorder. Conclusions Race was not a factor in duration of shelter tenure, or in securing or maintaining housing following shelter stay. Arrest history and lifetime substance use disorder were associated with more negative outcomes following transitional shelter stay.
Published: 2021

53. Vaccine Hesitancy Narratives

Author: Jennifer Breznay, Ashley Stewart, Johanna Crane, David Hoffman, and Kara Simpson
Subjects: Ethics, Emergency Approval, R723-726, Coronavirus disease 2019 (COVID-19), Medical philosophy. Medical ethics, Vaccine Mandate, Healthcare Workers, COVID-19, Gender studies, Bioethics, BJ1-1725, Vaccine Hesitancy, Narrative, Sociology, Medical Distrust
Abstract: Photo by Hush Naidoo Jade Photography on Unsplash INTRODUCTION In this collection of narratives, the authors describe their own experiences with and reflections on healthcare worker vaccine hesitancy. The narratives explore each author’s engagement with different communities experiencing vaccine hesitancy, touching on reasons for hesitancy, proposed solutions, and legal aspects. Author’s names appear above their narratives. l. Johanna T. Crane Vaccine hesitancy, defined as “a delay of acceptance or refusal of vaccination despite the availability of vaccination services,”[1] is a worldwide but locally shaped phenomenon that pre-dates the COVID-19 pandemic.[2] Contrary to some portrayals, vaccine hesitancy is not the same as the more absolute antivaccination stance, or what some call “anti-vax.” Many people who are hesitant are not ideologically opposed to vaccines. Hesitancy is also sometimes framed as anti-science, yet reluctance to vaccinate is often about managing risk, trustworthiness, and doubt in the context of uncertainty; it represents an effort to “talk back to science” about unaddressed needs and concerns.[3] In the US, the newness of the vaccines, the unprecedented speed at which they were developed, and their remaining under emergency use authorization at first complicated public confidence. Political polarization and racial and social inequality shape vaccine acceptance and public distrust as well. While vaccine acceptance has increased in the months since the vaccines first became available, many eligible individuals have not yet been vaccinated, including a significant number of healthcare workers.[4] Vaccine hesitancy among healthcare workers may seem surprising, especially given their frontline experience – I confess that it surprised me at first. But when I began interviewing health care workers for a study on COVID vaccine roll-out at community health centers, I learned to take a more complex view. Although the study was focused on patient vaccine access,[5] many of the frontline health care workers we spoke with also described hesitancy among some of their colleagues (and, in a few cases, themselves). From these conversations, I learned that these “healthcare heroes” are also regular people and members of communities. Their concerns about COVID vaccination often reflect the prevailing concerns advanced in their communities, such as worries about vaccine side effects and safety. Like other workers, some fear missing work and losing income, as not all healthcare employers offer paid time off for vaccination or recovery. (Importantly, reluctance to vaccinate is highest among healthcare workers in lower-paid positions with little job security, such as clerks, housekeepers, patient care assistants, and home health aides.)[6] For some healthcare workers of color, the protection offered by the vaccine sits in tension with both current and historical experiences of medical abuse and neglect. Some interviewees, fully vaccinated themselves, rejected the framework of “hesitancy” entirely, arguing that Black and Brown reluctance to be vaccinated first should be understood through the lens of “self-protection”. Due to the nature of their work, healthcare workers have faced great social pressure to vaccinate and vaccinate first. This is understandable, given that vaccination against COVID-19 protects not only workers themselves but aligns with the ethical duty to prevent harm to patients by reducing the risk of transmission in healthcare settings. When the FDA approved COVID-19 vaccines under emergency use authorization in December 2020, many healthcare workers were extremely grateful to be designated “1a” – the first group prioritized to receive the shots.[7] For many bioethicists, prioritization of healthcare workers represented a recognition of the extreme risks that many front-line workers had endured since the onset of the pandemic, including critical shortages in PPE. But it is important to remember that for some workers, going first may have felt like serving as guinea pigs for new vaccines that had yet to be granted full FDA approval. For these individuals, the expectation that they would vaccinate first may have felt like an additional risk rather than a reward. Healthcare workers who are hesitant to vaccinate may feel ashamed or be subject to shaming by others;[8] this may make it difficult to discuss their concerns in the workplace. Throughout the pandemic, healthcare workers have been lauded as “heroes”, and some healthcare employers have promoted vaccination among their workforce as a “heroic” action. This messaging implies that waiting to vaccinate is shameful or cowardly and is echoed in opinion pieces and op-eds describing unvaccinated people as “selfish” or “free riders.”[9] By fostering the proper dialogue, we can respond respectfully to hesitancy among healthcare workers while still working towards the goal of increased vaccination. We in the bioethics and medical community should be willing to listen to our colleagues’ concerns with respect. Top-down approaches aimed at “correcting” hesitancy cannot address the more fundamental issues of trust that are often at stake. Instead, there must be dialogue over time. Conversations with a trusted healthcare provider have a crucial role.[10] Blaming and shaming rhetoric, whether explicit or implicit, gets us nowhere – in fact, it likely moves us backward by likely exacerbating any existing distrust or resentment that workers may hold toward their employers.[11] Lastly, the onus of trust must be with institutions, not individuals. There is a lot of talk about getting communities of color, and Black people, particularly, to "trust" healthcare institutions and the COVID vaccines. This racializes trust and puts the burden on harmed communities rather than on institutions acting in trustworthy ways.[12] Dialogue, respect, and trustworthiness must guide us even in the new era of workplace mandates. Mandates make these strategies even more important as we look toward an uncertain future. As Heidi Larson, founder of the Vaccine Confidence Project, recently said, “We should not forget that we are making people's future history now. Are people going to remember that they were treated respectfully and engaged?”[13] ll. Kara Simpson Since the release of the vaccine for COVID-19 in late 2020, there have been robust discussions within the medical community, the media, and political arenas about vaccine hesitancy among healthcare workers. The public became aware that healthcare workers, the first group to become eligible for the vaccine, were not rushing to “take the shot.” Many people’s opinions were aligned by race, ethnicity, socioeconomic status, and political affiliation. People of color were one of the first groups to be labeled vaccine hesitant as our experiences of distrust of the medical community and the politicization of the vaccine explained the low turnout.[14] It was not uncommon to hear, “this vaccine just came out; let’s wait and see if there are side effects.” Interestingly, many people in the healthcare community and in the public did not understand why healthcare workers of color remained hesitant. Trust is a vital component of any viable relationship, especially in the clinical realm. To have successful health outcomes, it is essential for clinicians to build trusting relationships with their patients and peers. Many people of color are distrustful towards the medical institution due to the years of systemic racism and abuses that they have experienced, witnessed, or learned about. Healthcare workers of color are not excluded from the experiences of their communities outside of work. In fact, I assert that healthcare of color may have an additional burden of hesitation because of their lived experiences of distrust in receiving care and inequality within their professional environment. These dual traumas can work in tandem to strengthen hesitancy. I assert that building trusting clinical relationships will address hesitancy over time. Currently, many healthcare workers are worried about vaccine mandates. For a group of people that have experienced intergenerational enslavement and marginalization, mandates feel coercive and serve as a reminder of how “lesser” bodies are considered unworthy of voice, fundamental human rights, independent decision making. To call the vaccine mandate paternalistic would be an understatement. An unintended result of vaccine mandates will be the reinforcement of hesitancy and distrust of the medical institution as trust and coercion cannot coexist. This mandate will give more power to the conspiracy theories and harm those who already do not seek or receive adequate health care because of systemic inequalities. Furthermore, mandates can also dissuade people of color from becoming healthcare workers, and others may leave the field. In essence, vaccine hesitancy is a symptom of a much larger problem: the distrust of the medical establishment. As bioethicists, our mission should be to support interventions that foster “trustworthiness” of the institutions rather than those that cause trauma. Several organizations have proposed mask mandates and weekly testing as a measure to protect the population at large and still respect the autonomy of the unvaccinated.[15] lll. Jennifer Breznay I work in a very large community teaching hospital in Brooklyn, and we were extremely hard hit by COVID in March 2020. I worked on inpatient medical units and witnessed a lot of suffering. And after nine months of fear and despair about COVID’s toll, I felt tremendous frustration in December when I heard that many healthcare workers would reject the vaccine. As the co-chair of the Bioethics Committee, I drafted a statement recommending vaccination for all employees. When the draft was revised and approved by the Bioethics Committee, I began to discuss it with employees, and I appreciated different perspectives I had not heard before. In the end, rather than releasing the statement, we directed our efforts at creating a dialogue. I also volunteer at a not-for-profit which operates seven early childhood education centers in Northern Brooklyn. The Executive Director invited me to collaborate on strategies to encourage staff vaccination, and we decided to offer a Zoom conference to 20 members of the staff. I was extremely nervous about how the audience would perceive me, a white doctor whom they did not know. I felt awkward about coming to them with an agenda. And there was also the question of whether I was an appropriate messenger compared to a person of color. Yet, I felt like I shouldn't back away from this. So, I chose to simply disclose my discomfort at the beginning of the Zoom. I said, “Thanks for having me. You know, as a white physician, I understand you might have concerns about trusting what I say. Four hundred years of inequity and abuse by the healthcare system can create a lot of mistrust, but I’m here to try to answer your questions.” Ultimately the Executive Director reported that the Zoom was successful in stimulating a lot of conversation among the staff about the vaccine. I think the critical piece is the intimate but open conversation, where you can elicit values. lV. Ashley L. Stewart In the rural areas of our state, healthcare institutions are inextricably tied to their communities. Rural hospitals hire from, serve, and function in the community where they are located. Successful implementation of a vaccine roll-out in such rural areas requires explicit recognition of the role and influence of the community. After identifying issues common to the area, rural institutions can address them. Even when rural institutions find that healthcare worker concerns seem to be unique or personal, they are often related to the larger concerns of the community.[16] Community-based increased vaccine hesitancy may coincide with an underlying issue, such as lack of information rather than principled or experience-based resistance.[17] When the vaccines became available, rural vaccination coordinators encountered a wealth of misinformation that left many people initially undecided. Compounding this lack of information, workers expressed a sense of fear about the professional consequences of voicing concerns, especially in tight-knit communities. Many workers expressed concern about being judged merely for sharing their questions or decisions.[18] They also felt that saying or doing something to promote the value of vaccination might change their relationship with members of the community where they live and work.[19] As there was a fear of engaging in productive conversations, it was difficult for them to find valuable information, and the lack of information discouraged them from being vaccinated. Vaccine coordinators wanted to get information to the entire community based on the most current research and release unbiased, consistent, and timely information from sources all people in the community could trust, including from multiple sources at once. Communication must focus on answering many types of questions, which must often be done in private or anonymously. Where poorly supported or incorrect information is widely available, sharing objective information is crucial to turning the tide of distrust. If the healthcare community dismisses concerns or assumes that answering questions based on misinformation is a waste of time, the community-based institutions will further the distrust. Some may feel that vaccine coordinators should not address misinformation directly, yet avoidance has been widely unsuccessful.[20] Being respectful and non-judgmental in answering questions posed by people who do not know what is true can be hard, but in rural communities, answering completely and honestly without judgment is a critical component of any effort to inform people. Telling people to get vaccinated “for the greater good” can sound the same as being told not to get a vaccine because it is “bad” if both sources of information fail to back up their claims. Ultimately rural institutions are respected because they are a resource to their communities, a priority we must preserve. It is also critical to treat everyone respectfully regardless of vaccine status.[21] People may perceive mandates, divisive policies, or disrespectful treatment of people based on vaccination status as discriminatory or coercive, weakening the appeal of vaccination. Such practices may make people less trusting and more anchored to their position as they come to see vaccination proponents as untrustworthy or authoritarian. We must work to maintain respect for human autonomy. Using unethical means to achieve even a just end will not lead to a “greater good” but rather to the perception that people in positions of authority would achieve a result “by any means necessary.” V. David N. Hoffman The central moral quandary that arises whenever vaccine hesitancy among healthcare workers is discussed is whether workers who refuse to get vaccinated should or could be fired. We should clarify that we are applying a definition of mandate in the employment context for private employers, the violation of which results in loss of employment. Government-controlled provider organizations are just now weighing in on this topic and are generally pursuing strategies that impose periodic, usually weekly, testing requirements for those workers who decline to get vaccinated. In the private sector, employers can require their employees to do a great many things as a condition of employment, and one of them is to get vaccinated against COVID -19. In the most prominent case to date, just such a mandate gave rise to a lawsuit in Texas involving Houston Methodist Hospital. In that case, 170 employees asserted that an employer should not be allowed to force them to get vaccinated. The judge held that, while no employer can force an employee to get vaccinated, no employer is obligated to continue the employment of any employee who declines to follow rules established by that employer, including the obligation to get vaccinated.[22] In Texas, what the judge said is you are not being forced to get vaccinated, but your employer is allowed to set limits and conditions on employment, including vaccination. Employees do not have an obligation to get vaccinated, but they also have no right to their jobs. That is because of a widely misunderstood legal concept: “employment at will.” Employment at will sounds like a rule that employees can do what they want at work, but in fact, employment at will means only that you can quit your job whenever you want (we do not permit indentured servitude). At the same time, your employer can fire you at any time, for any reason or no reason, unless the reason is a pretext and involves one of the protected statuses (race, color, religion, sex, or national origin, and in some jurisdictions gender orientation, gender identity). Generally, any employers, including hospitals, can decide that if someone is not willing to get a vaccination, or if they are not willing to complete sexual harassment training or participate in the hospital’s infection control program, that is the employee’s right, but it will mean that an employer can similarly decline to continue providing employment. The evolution of this hesitancy discussion will be influenced by the narrower debate playing out in the court of public opinion, and the courts of law, over the enforceability of New York’s recently enacted vaccine mandate. Regardless of whether that mandate survives, with or without medical and religious exemptions, healthcare employers will be left with a profound ethical dilemma. At the end of all the litigation, if there is a religious exemption, employers will always be burdened with the responsibility to determine whether an individual employee has asserted a genuine and sincere religious objection to vaccination and whether the employer is able to provide an accommodation that is safe and effective in protecting the interests of co-workers and patients. The anticipated federal mandate, which reportedly will have a test/mask alternative, will only make this ethical task more challenging. This leads to the final point in this analysis, which is that while private employers, including hospitals, can deprive an individual of their employment if those individuals refuse to get vaccinated, just because an employer can do so does not mean it should do so.[23] - [1] MacDonald NE. Vaccine hesitancy: Definition, scope and determinants. Vaccine. 2015;33(34):4161-4164. doi:10.1016/j.vaccine.2015.04.036 [2] Larson HJ, de Figueiredo A, Xiahong Z, et al. The State of Vaccine Confidence 2016: Global Insights Through a 67-Country Survey. EBioMedicine. 2016;12:295-301. doi:10.1016/j.ebiom.2016.08.042 [3] Larson H. Stuck: How Vaccine Rumors Start - and Why They Don’t Go Away. Oxford University Press; 2020; Benjamin R. Informed Refusal: Toward a Justice-based Bioethics. Sci Technol Hum Values. 2016;41(6):967-990. doi:10.1177/0162243916656059 [4] Deepa Shivaram, In The Fight Against COVID, Health Workers Aren't Immune To Vaccine Misinformation September 18, 2021. NPR Special Series: The Coronavirus. https://www.npr.org/2021/09/18/1037975289/unvaccinated-covid-19-vaccine-refuse-nurses-heath-care-workers [5] Crane JT, Pacia D, Fabi R, Neuhaus C, and Berlinger N. Advancing Covid vaccination equity at Federally Qualified Health Centers: A rapid qualitative review. Accepted and awaiting publication at JGIM. [6] Ashley Kirzinger. “KFF/The Washington Post Frontline Health Care Workers Survey - Vaccine Intentions.” KFF, 22 Apr. 2021, https://www.kff.org/report-section/kff-washington-post-frontline-health-care-workers-survey-vaccine-intentions/. [7] Johanna Crane, Samuel Reis-Dennis and Megan Applewhite. “Prioritizing the ‘1a’: Ethically Allocating Scarce Covid Vaccines to Health Care Workers.” The Hastings Center, 21 Dec. 2020, https://www.thehastingscenter.org/prioritizing-the-1a-ethically-allocating-covid-vaccines-to-health-care-workers/. [8] “'I'm Not an Anti-Vaxxer, but...' US Health Workers' Vaccine Hesitancy Raises Alarm.” The Guardian, Guardian News and Media, 10 Jan. 2021, https://www.theguardian.com/world/2021/jan/10/coronavirus-covid-19-vaccine-hesitancy-us-health-workers. [9] Gerson M. If you are healthy and refuse to take the vaccine, you are a free-rider. Washington Post. April 15, 2021. [10] Crane JT, Pacia D, Fabi R, Neuhaus C, and Berlinger N. Advancing Covid vaccination equity at Federally Qualified Health Centers: A rapid qualitative review. Accepted and awaiting publication at JGIM. [11] Larson H. Stuck : How Vaccine Rumors Start - and Why They Don’t Go Away. Oxford University Press; 2020. [12] Benjamin R. Race for Cures: Rethinking the Racial Logics of ‘Trust’ in Biomedicine. Sociology Compass. 2014;8(6):755-769. doi:10.1111/soc4.12167; Warren RC, Forrow L, David Augustin Hodge S, Truog RD. Trustworthiness before Trust — Covid-19 Vaccine Trials and the Black Community. N Engl J Med. Published online October 16, 2020. doi:10.1056/NEJMp2030033 [13] Offri D. Heidi Larson, Vaccine Anthropologist. New Yorker. Published online June 12, 2021. Accessed August 11, 2021. https://www.newyorker.com/science/annals-of-medicine/heidi-larson-vaccine-anthropologist [14] Razai M S, Osama T, McKechnie D G J, Majeed A. Covid-19 Vaccine Hesitancy Among Ethnic Minority Groups. BMJ 2021; 372 :n513 doi:10.1136/bmj.n513 [15] Dasgupta, Sharoda, et al. “Differences in Rapid Increases in County-Level COVID-19 Incidence by Implementation of Statewide Closures and Mask Mandates — United States, June 1–September 30, 2020.” Annals of Epidemiology, vol. 57, Sept. 2021, pp. 46–53., https://doi.org/10.1016/j.annepidem.2021.02.006. [16] Do, Tuong Vi C et al. “COVID-19 Vaccine Acceptance Among Rural Appalachian Healthcare Workers (Eastern Kentucky/West Virginia): A Cross-Sectional Study.” Cureus vol. 13,8 e16842. 2 Aug. 2021, doi:10.7759/cureus.16842; Danabal, K.G.M., Magesh, S.S., Saravanan, S. et al. Attitude towards COVID 19 vaccines and vaccine hesitancy in urban and rural communities in Tamil Nadu, India – a community-based survey. BMC Health Serv Res 21, 994 (2021). https://doi.org/10.1186/s12913-021-07037-4 [17] Scott C. Ratzan MD, MPA, MA, Lawrence O. Gostin JD, Najmedin Meshkati PhD, CPE, Kenneth Rabin PhD & Ruth M. Parker MD (2020) COVID-19: An Urgent Call for Coordinated, Trusted Sources to Tell Everyone What They Need to Know and Do, Journal of Health Communication, 25:10, 747-749, DOI: 10.1080/10810730.2020.1894015 [18] Huang, Pien. “Some Health Care Workers Are Wary of Getting COVID-19 Vaccines.” NPR, NPR, 1 Dec. 2020, https://www.npr.org/sections/health-shots/2020/12/01/940158684/some-health-care-workers-are-wary-of-getting-covid-19-vaccines. Portnoy, Jenna. “Several Hundred Virginia Health-Care Workers Have Been Suspended or Fired over Coronavirus Vaccine Mandates.” The Washington Post, WP Company, 4 Oct. 2021, https://www.washingtonpost.com/local/covid-vaccine-mandate-hospitals-virginia/2021/10/01/b7976d16-21ff-11ec-8200-5e3fd4c49f5e_story.html. [19] Jennifer A. Lueck & Alaina Spiers (2020) Which Beliefs Predict Intention to Get Vaccinated against COVID-19? A Mixed-Methods Reasoned Action Approach Applied to Health Communication, Journal of Health Communication, 25:10, 790-798, DOI: 10.1080/10810730.2020.1865488 [20] Lockyer, Bridget, et al. “Understanding Covid-19 Misinformation and Vaccine Hesitancy in Context: Findings from a Qualitative Study Involving Citizens in Bradford, UK.” Health Expectations, vol. 24, no. 4, 4 May 2021, pp. 1158–1167., https://doi.org/10.1101/2020.12.22.20248259. Scott C. Ratzan & Ruth M. Parker (2020) Vaccine Literacy—Helping Everyone Decide to Accept Vaccination, Journal of Health Communication, 25:10, 750-752, DOI: 10.1080/10810730.2021.1875083. [21] Zimmerman, Anne. Columbia Academic Commons, 2020, Toward a Civilized Vaccination Discussion: Abandoning the False Assumption That Scientific Goals Are Shared by All, https://academiccommons.columbia.edu/doi/10.7916/d8-rzh0-1f73. [22] Bridges, et al v. Houston Methodist Hospital et al, https://docs.justia.com/cases/federal/districtcourts/texas/txsdce/4:2021cv01774/1830373/18 [23] David N. Hoffman, “Vaccine Mandates for Health Care Workers Raise Several Ethical Dilemmas,” Hasting Center Bioethics Forum. August 2021. https://www.thehastingscenter.org/vaccine-mandates-for-health-care-workers-raise-several-ethical-dilemmas/
Published: 2021
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54. Notes on Translating Solitons for Mean Curvature Flow

Author: Tom Ilmanen, Brian White, David Hoffman, and Francisco Martín
Subjects: Mean curvature flow, 010102 general mathematics, 0103 physical sciences, Gravitational singularity, 010307 mathematical physics, 0101 mathematics, 01 natural sciences, Mathematics, Mathematical physics
Abstract: These notes provide an introduction to translating solitons for the mean curvature flow in $\mathbf {R}^3$. In particular, we describe a full classification of the translators that are complete graphs over domains in $\mathbf {R}^2$.
Published: 2021
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55. Phase 1/1b study of telisotuzumab vedotin (Teliso-V) + osimertinib (Osi), after failure on prior Osi, in patients with advanced, c-Met overexpressing, EGFR-mutated non-small cell lung cancer (NSCLC)

Author: Jonathan W. Goldman, Hidehito Horinouchi, Byoung Chul Cho, Pascale Tomasini, Martin Dunbar, David Hoffman, Apurvasena Parikh, Vincent Blot, and D. Ross Camidge
Subjects: Cancer Research, Oncology
Abstract: 9013 Background: Osi (third-generation tyrosine kinase inhibitor) is a standard frontline treatment (Tx) for advanced/metastatic EGFR-mutated NSCLC. However, tumors invariably progress after an initial response, with c-Met protein overexpression (OE) often associated with acquired resistance. Second- and third-line Tx options are limited to chemotherapy-based regimens with limited efficacy and significant toxicities. Teliso-V (ABBV-399), an anti–c-Met antibody-drug conjugate, delivers a cytotoxic payload (monomethyl auristatin E) into c-Met OE tumor cells. In a phase 1/1b study (NCT02099058) in patients (pts) with c-Met OE NSCLC, Teliso-V alone or in combination with erlotinib demonstrated an acceptable safety profile and antitumor activity. Interim safety and efficacy data from the Teliso-V + Osi cohort (arm E) of this trial are presented. Methods: Pts (≥18 yr) with metastatic EGFR-mutated, c-Met OE (by central immunohistochemistry) NSCLC who had progressed on a prior Osi regimen were eligible. Pts received Teliso-V (IV Q2W) + Osi (oral; 80 mg QD). Teliso-V was evaluated at 1.6 mg/kg and, after review of safety data, escalated to 1.9 mg/kg (safety evaluation). An expansion cohort was opened at 1.9 mg/kg for pts who had received ≤2 prior lines of systemic therapy. Pharmacokinetics (PK) were assessed throughout the study. Pts received study Tx until disease progression, unacceptable toxicity, or for up to 24 months. Results: As of 20 Dec 2021, 25 pts received Teliso-V (1.6 mg/kg, n = 7; 1.9 mg/kg, n = 18) + Osi. Median age was 60.0 yr; 14 (58%) pts were on prior Tx with Osi for > 12 mo. No dose-limiting toxicities (grade [Gr] ≥3 non-hematologic or Gr 4 hematologic Tx-related adverse events [AEs]) were reported during the safety lead-in or evaluation phases. All-Gr AEs considered possibly related to Teliso-V occurred in 22/25 (88%) pts: the most common (≥20%) were peripheral sensory neuropathy (36%), nausea, and peripheral edema (20% each); Gr ≥3 AEs (> 5%) were anemia (12%) and peripheral motor neuropathy (8%). No Gr 5 events related to Tx were reported. PK of Teliso-V + Osi was similar to single-agent Teliso-V. Efficacy data (19/25 pts) are in the table. The overall objective response rate (ORR) was 58% (67% at 1.9 mg/kg). Conclusions: Teliso-V + Osi is well tolerated with an ORR of 58% (67% at 1.9 mg/kg) in pts with c-Met OE NSCLC who progressed on prior Osi. Clinical trial information: NCT02099058. [Table: see text]
Published: 2022
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56. A Family of Singly Periodic Minimal Surfaces Invariant under a Screw Motion.

Author: Michael J. Callahan, David Hoffman, and Hermann Karcher
Published: 1993
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57. Relationships Over Rules : 7 Principles to Lead Gracefully and Love Generously

Author: David Hoffman and David Hoffman
Abstract: Your path to purpose begins with people.Relationships. We know that we need them, but busy schedules, financial pursuits, and self-serving agendas often distract us from the people God has placed in our lives.Overcoming a childhood that lacked true relationships, CEO David Hoffman successfully broke the rules of a transaction-based world by founding a real estate company focused on meeting people where they are. In Relationships over Rules, David shares his journey and seven principles you can adopt to build authentic relationships that will help youwelcome opportunities for growth and service,reach your potential regardless of your past,live with perspective and gratitude, andfulfill the great plans God has for you.Guided by true stories and application exercises, watch your life transform as you pour yourself into those around you. You can achieve lasting success when you put relationships first.
Published: 2023

58. Welding

Author: David J Hoffman, David Hoffman, Kevin R. Dahle, Kevin R Dahle, David Fisher, David J Hoffman, David Hoffman, Kevin R. Dahle, Kevin R Dahle, and David Fisher
Subjects: Welding
Abstract: Welding offers an easy-to-read, highly visual “diameter of electrodes” approach to welding. The text provides engaging, reference-friendly coverage of the theory, safety issues and key skills of welding. Its emphasis on the diameter of electrodes, the preferred method across schools and home shop settings, distinguishes this title from others of its kind. Drawing on 50 years'combined experience, the authors provide setups for every important weld, along with step-by-step photos and procedures for each step. With concise, cleanly designed chapters, the 3rd Edition adds new media features, including 30 animations and 60 video presentations. It also has a new chapter: Advanced Gas Metal Arc Welding. It now encompasses newer safety standards, additional welding techniques and current welding innovations.
Published: 2023

59. Myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS): Where will the drugs come from?

Author: David Hoffman, Peter L. Toogood, Sameer Phadke, and Daniel J. Clauw
Subjects: musculoskeletal diseases, 0301 basic medicine, medicine.medical_specialty, 2019-20 coronavirus outbreak, Coronavirus disease 2019 (COVID-19), Encephalomyelitis, Disease, medicine.disease_cause, Viral infection, Antiviral Agents, 03 medical and health sciences, 0302 clinical medicine, Intervention (counseling), Drug Discovery, Chronic fatigue syndrome, medicine, Animals, Humans, Immunologic Factors, Intensive care medicine, Pharmacology, Analgesics, Fatigue Syndrome, Chronic, business.industry, COVID-19, Immune dysregulation, medicine.disease, 030104 developmental biology, 030220 oncology & carcinogenesis, business
Abstract: Myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS) is a chronic debilitating disease characterized by severe and disabling fatigue that fails to improve with rest; it is commonly accompanied by multifocal pain, as well as sleep disruption, and cognitive dysfunction. Even mild exertion can exacerbate symptoms. The prevalence of ME/CFS in the U.S. is estimated to be 0.5-1.5 % and is higher among females. Viral infection is an established trigger for the onset of ME/CFS symptoms, raising the possibility of an increase in ME/CFS prevalence resulting from the ongoing COVID-19 pandemic. Current treatments are largely palliative and limited to alleviating symptoms and addressing the psychological sequelae associated with long-term disability. While ME/CFS is characterized by broad heterogeneity, common features include immune dysregulation and mitochondrial dysfunction. However, the underlying mechanistic basis of the disease remains poorly understood. Herein, we review the current understanding, diagnosis and treatment of ME/CFS and summarize past clinical studies aimed at identifying effective therapies. We describe the current status of mechanistic studies, including the identification of multiple targets for potential pharmacological intervention, and ongoing efforts towards the discovery of new medicines for ME/CFS treatment.
Published: 2020

60. Limiting behavior of sequences of properly embedded minimal disks

Author: David Hoffman and Brian White
Subjects: Mathematics - Differential Geometry, Work (thermodynamics), Algebra and Number Theory, Minimal surface, Euclidean space, Hyperbolic space, Mathematical analysis, Limiting, Curvature, Differential Geometry (math.DG), 53A10 (Primary), 49Q05, 53C42 (Secondary), Simply connected space, FOS: Mathematics, Mathematics::Differential Geometry, Geometry and Topology, Limit (mathematics), Analysis, Mathematics
Abstract: We develop a theory of "minimal $\theta$-graphs" and characterize the behavior of limit laminations of such surfaces, including an understanding of their limit leaves and their curvature blow-up sets. We use this to prove that it is possible to realize families of catenoids in euclidean space as limit leaves of sequences of embedded minimal disks, even when there is no curvature blow-up. Our methods work in a more general Riemannian setting, including hyperbolic space. This allows us to establish the existence of a complete, simply connected, minimal surface in hyperbolic space that is not properly embedded., Comment: 32 pages, 1 figure
Published: 2020
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61. Dead End Streets

Author: David Hoffman
Subjects: Underpinning, Consolidation (business), Dead end, Political science, media_common.quotation_subject, Social change, Photography, Media studies, Social control, Democracy, New media, media_common
Abstract: This chapter intends to make the forces visible to a wider group than just the participants and in that way to democratise protest so that all of society is to an extent involved in the issues that relatively few bring to the streets. The new media platforms that seemed to offer so much by way of broadening the audience and democratising access have proved to be hollow. Indymedia and Demotix were two very different examples of such platforms that promised democratic access, but neither had much of an audience, and both recently ceased to exist. The consolidation of publishers, suppliers and finance has driven a market for homogenous, focus group-approved products. The photographer's ability to use public events to build images that act as catalysts for social change requires a foundation, chiefly an economic underpinning.
Published: 2020
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62. Something That People Cannot Control, Something That People Can Overcome': Paradoxes in Discourse about Depression

Author: Ethan David Hoffman
Published: 2020
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63. Intrinsically radiolabeled multifunctional cerium oxide nanoparticles for in vivo studies

Author: Jamal Zweit, Minghao Sun, Likun Yang, Narottam Lamichhane, Philip Reed McDonagh, Gobalakrishnan Sundaresan, J. Manuel Perez, Purnima Jose, Cathy S. Cutler, and David Hoffman
Subjects: Biodistribution, Materials science, Biomedical Engineering, Nanotechnology, General Chemistry, General Medicine, Surface coating, chemistry.chemical_compound, Dextran, chemistry, In vivo, Spect imaging, Biophysics, Surface modification, General Materials Science, Viability assay, Ex vivo
Abstract: Cerium oxide nanoparticles (CONPs) have demonstrated protection properties against oxidation in various cells and tissues. The mechanism of this, however, is poorly understood. Monitoring the interaction of CONPs with biological compartments 'in situ' is crucial to understand their biochemical and physiological properties in vivo. In this paper, a multifunctional nanoparticle platform was obtained through an intrinsic radiolabeling strategy and extrinsic surface functionalization to combine dual imaging components (Single Photon Emission Computed Tomography/Optical Imaging, SPECT/OI) in one nanoparticle. The cell viability, cell uptake and overall in vivo biodistribution of CONPs were also manipulated through surface functionalization. The intrinsic radiolabeling strategy is demonstrated by incorporating radionuclides (141Ce, 111In or 65Zn) into CONPs and a radiolabeled CONP (rCONP) was coated with biocompatible polymers including Dextran T10 (DT10), poly(acrylic acid) (PAA), or functionalized DT10 (DT10-NH2, DT10-PEG and DT10-sulfobetaine). Fluorescent CONPs were obtained through conjugation of fluorescein isothiocyanate (FITC) with DT10-NH2 rCONP and used for cell imaging. The DT10 and DT10-NH2 rCONP did not show decreased viability up to 120 μg mL-1 whilst the PAA rCONP showed decreased viability beyond 40 μg mL-1. Variations in blood circulation and renal/hepatic clearance of rCONPs were demonstrated and were dependent on surface coating and the hydrodynamic size of nanoparticles. The ex vivo biodistribution results were reflected in SPECT imaging of 141Ce-rCONPs, showing accumulation in the liver and spleen of a living mouse over a one week period. The intrinsic radiolabeling and extrinsic surface modifications together determine the biophysical properties of CONPs and their potential applications for in vivo studies and biomedical imaging.
Published: 2020

64. Accelerating drug development in pediatric cancer: a novel Phase I study design of venetoclax in relapsed/refractory malignancies

Author: Mignon L. Loh, Thalia A. Farazi, Daniel A. Morgenstern, C. Michel Zwaan, Kelly C. Goldsmith, Jean-Pierre Bourquin, Maria Verdugo, Yeshwant D. Sanzgiri, Josef Vormoor, David Hoffman, Mohamad Shebley, Betty Prine, Megan McNamee, Andrew E. Place, Jeremy A. Ross, Lia Gore, Ying Zhou, Su Young Kim, L. Leanne Lash-Fleming, University of Zurich, Place, Andrew E, and Pediatrics
Subjects: 0301 basic medicine, Oncology, Cancer Research, medicine.medical_specialty, Chronic lymphocytic leukemia, medicine.medical_treatment, Antineoplastic Agents, 610 Medicine & health, 03 medical and health sciences, chemistry.chemical_compound, 0302 clinical medicine, Clinical Protocols, Drug Development, SDG 3 - Good Health and Well-being, Refractory, Recurrence, Neoplasms, Internal medicine, medicine, Humans, 1306 Cancer Research, Sulfonamides, Chemotherapy, business.industry, Venetoclax, Age Factors, General Medicine, Bridged Bicyclo Compounds, Heterocyclic, medicine.disease, Pediatric cancer, Phase i study, Treatment Outcome, 030104 developmental biology, Drug development, chemistry, Drug Resistance, Neoplasm, Research Design, 10036 Medical Clinic, Child, Preschool, 030220 oncology & carcinogenesis, Relapsed refractory, 2730 Oncology, business, Biomarkers
Abstract: Venetoclax is a highly selective, potent BCL-2 inhibitor that is approved for some patients previously treated for chronic lymphocytic leukemia, and has shown promising activity in adult studies across several hematologic malignancies. Preclinical studies have demonstrated venetoclax activity in pediatric patient-derived xenograft models and cell lines; however, clinical studies in pediatric patients have yet to be conducted. The prognosis is poor for children with most relapsed/refractory malignancies, and limited treatment options result in unmet clinical need. Herein, we describe the rationale and design of the first study of venetoclax in pediatric patients with relapsed/refractory malignancies: a Phase I trial investigating the safety and pharmacokinetics of venetoclax monotherapy followed by the addition of chemotherapy (Trial registration: EudraCT 2017-000439-14; NCT03236857).
Published: 2018
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65. Defining the abdominal radiologist based on the current U.S. job market

Author: Andrew B. Rosenkrantz and David Hoffman
Subjects: Employment, Radiography, Abdominal, medicine.medical_specialty, Breast imaging, Urology, education, Psychological intervention, Colonoscopy, Subspecialty, Job market, 030218 nuclear medicine & medical imaging, 03 medical and health sciences, 0302 clinical medicine, Radiologists, Humans, Medicine, Fluoroscopy, Radiology, Nuclear Medicine and imaging, Practice Patterns, Physicians', Internet, Modalities, Radiological and Ultrasound Technology, medicine.diagnostic_test, business.industry, Gastroenterology, United States, Job Description, Private practice, 030220 oncology & carcinogenesis, Workforce, Radiology, business
Abstract: The purpose of the study is to characterize current practice patterns of abdominal radiologists based on work descriptions within job postings on numerous national radiology specialty websites. Job postings for either “abdominal” or “body” radiologists were searched weekly on five society websites (SAR, SCBT-MR, ARRS, ACR, RSNA) over a 1-year period. Postings were reviewed for various characteristics. Nine hundred and sixteen total ads for 341 unique abdominal radiologist positions were reviewed (34.6% academic, 64.2% private practice, 1.2% other). Postings occurred most commonly in March (12.3%) and least commonly in November (4.8%). States with most positions were Florida (27), California (26), and New York (24). Of postings delineating expectations of specific abdominal modalities, 67.4% mentioned MRI, 58.5% ultrasound, 41.1% fluoroscopy, 14.3% PET, and 54.0% interventions. Additional non-abdominal expectations included general radiology (28.7%), breast imaging (21.1%), and general nuclear medicine (9.7%). Additional skills included prostate MRI (7.0%), OBGYN ultrasound (5.0%), and CT colonoscopy (2.6%). 79.2% required an abdominal imaging fellowship (specifically a body MRI fellowship in 4.1%). By using job postings for abdominal radiologists, we have taken a practical approach to characterizing the current status of this subspecialty, reflecting recent job expectations and requirements. The large majority of positions required a body fellowship, and the positions commonly entailed a variety of skills beyond non-invasive diagnostic abdominal imaging. Of note, expectations of considerable minorities of positions included abdominal interventions, general radiology, and breast imaging. These insights may guide the development of abdominal radiology fellowships and mini-fellowships, as well as assist radiologists entering or returning to the job market.
Published: 2018
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66. Emerging issues, solutions & challenges from the top 20 issues affecting web application accessibility.

Author: David Hoffman and Lisa Battle
Published: 2005
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67. Molecular Responses Are Observed across Mutational Spectrum in Treatment-Naïve Higher-Risk Myelodysplastic Syndrome Patients Treated with Venetoclax Plus Azacitidine

Author: Joseph G. Jurcic, Uwe Platzbecker, Diana Ronai Dunshee, Steve Kye, Kiran Naqvi, Ying Zhou, Jacqueline S. Garcia, Andrew H. Wei, Daniel Nowak, Relja Popovic, Meagan A. Jacoby, Maria R. Baer, Olatoyosi Odenike, Leah Hogdal, Chun Yew Fong, Ilona Cunningham, David Hoffman, Yan Sun, Guillermo Garcia-Manero, Barrett Ainsworth, Pierre Peterlin, and Uma Borate
Subjects: Oncology, medicine.medical_specialty, Venetoclax, business.industry, Immunology, Azacitidine, Cell Biology, Hematology, Biochemistry, Therapy naive, chemistry.chemical_compound, chemistry, Internal medicine, medicine, business, medicine.drug
Abstract: Introduction: Patients (pts) with higher-risk myelodysplastic syndromes (MDS) are typically treated with azacitidine (Aza). Venetoclax (Ven) is a selective, potent, oral BCL-2 inhibitor that has demonstrated synergy with Aza in preclinical studies of myeloid malignancies. Higher-risk MDS is associated with mutations in genes involved in RNA splicing, epigenetic regulation, transcription, and cellular signaling. Assessing the dynamics of genetic variants during treatment of higher-risk MDS enables understanding of the molecular determinants of response. This phase 1b study (NCT02942290) evaluates Ven + Aza for treatment-naïve higher-risk MDS, and we report efficacy among mutationally defined subgroups as well as the depth of molecular response. Methods: Pts (≥18 years) with higher-risk MDS enrolled in the study had International Prognostic Scoring System intermediate-2 or high-risk MDS, bone marrow (BM) blasts Molecular responses were quantified by mutation analysis of baseline and serial BM aspirate (BMA) or peripheral blood (PB) samples collected at protocol-specified time points. Mutations were identified in BMA using Archer VariantPlex Myeloid 75-gene panel [limit of detection (LOD) 5%; time points: pre-treatment (n=43), on-treatment (n=32), and treatment completion visit (TCV) (n=25)] or TruSight Myeloid 54-gene Sequencing Panel in PB [LOD 2%; time points: pre-treatment (n=21), on-treatment (n=19), and TCV (n=8)] to assess molecular dynamics during Ven + Aza treatment. Molecular responses were only compared within the same tissue type. Results: At the Dec 15, 2020 cutoff, 78 pts had received Ven+Aza, including 51 who received Ven at the RP2D of 400 mg x 14 d, with median follow up time of 23 mos (range 0.1-44.2). Median age was 70 years (range 26-87); 72% male; and 91% had excess BM blasts (>5 to ≤10%, n=21; >10 to ≤20%, n=49; >20%, n=1). For the entire population, mORR was 80% (CR 40% and mCR 40%; no PR). 42% with mCR also had hematologic improvement [HI]. Screening mutational profiling was performed on 46/51 pts who received the RP2D of Ven + Aza. The most common mutations were TP53 (26%), ASXL1 (24%), U2AF1 (17%), and RUNX1 (15%), consistent with a higher-risk MDS population. Clinical responses (CR + mCR) were observed across the mutational spectrum, including in pts with poor prognostic mutations in TP53 (83%), ASXL1 (82%), and RUNX1 (71%). Sixty-four pts treated with Ven + Aza (all Ven dosing cohorts) had paired BMA or PB pre-treatment and on-treatment and/or end of study samples available for serial analysis at the Dec 15, 2020 data cutoff. Ven + Aza resulted in robust and rapid molecular responses across the mutational spectrum. Pts who achieved CR at the time of serial sample acquisition had more significant reduction of variant allele frequencies (VAFs) (n=18 pts, mean VAF pre-treatment = 38.3; mean VAF at CR = 11.8) compared to pts who achieved stable disease or HI (n=11 pts, mean VAF pre-treatment = 29.8; mean VAF at SD or HI = 24.0) or progressive disease (n=10 pts, mean VAF pre-treatment = 27.4; mean VAF at PD = 26.9). Reductions of VAFs below the LOD were observed across the mutational spectrum, including in genes that are considered poor prognostic in higher-risk MDS (e.g., TP53, ASXL1 and RUNX1), demonstrating the broad molecular activity of Ven + Aza (Figure). Finally, molecular responses were observed quickly, with VAF reductions below the LOD observed as early as end of Cycle 1, consistent with the mechanism of action of Ven directly activating the mitochondrial apoptotic pathway in cells. Conclusions: Pts with higher-risk MDS treated with Ven + Aza had rapid, durable responses and high remission rates. Pts across key mutational profiles achieved meaningful clinical and molecular responses, supporting an all-comers approach. Updated data will be presented, which will provide more follow up time and durability of responses among mutational subsets. Figure 1 Figure 1. Disclosures Garcia: Genentech: Research Funding; Takeda: Consultancy, Membership on an entity's Board of Directors or advisory committees; Astellas: Consultancy, Membership on an entity's Board of Directors or advisory committees; AbbVie: Consultancy, Membership on an entity's Board of Directors or advisory committees, Research Funding; AstraZeneca: Research Funding; Prelude: Research Funding; Pfizer: Research Funding. Wei: Novartis, Celgene, AbbVie, Servier, AstraZeneca, and Amgen: Research Funding; Novartis, Janssen, Amgen, Roche, Pfizer, Abbvie, Servier, BMS, Macrogenics, Agios, Gilead: Membership on an entity's Board of Directors or advisory committees; Astellas: Honoraria. Jacoby: Abbvie: Research Funding; Jazz: Research Funding. Fong: Amgen, BMS: Speakers Bureau; AbbVie, Amgen, Novartis, Pfizer, Astellas: Honoraria; Amgen: Research Funding. Borate: Jazz Pharma: Research Funding; Blueprint Medicine: Membership on an entity's Board of Directors or advisory committees; Astellas: Membership on an entity's Board of Directors or advisory committees; Pfizer: Membership on an entity's Board of Directors or advisory committees, Research Funding; AbbVie: Membership on an entity's Board of Directors or advisory committees, Research Funding; Genentech: Membership on an entity's Board of Directors or advisory committees, Other: Advisory Board; Novartis: Membership on an entity's Board of Directors or advisory committees, Research Funding; Takeda: Membership on an entity's Board of Directors or advisory committees; Daiichi-Sankyo: Membership on an entity's Board of Directors or advisory committees; incyte: Membership on an entity's Board of Directors or advisory committees, Research Funding; Rampal: Membership on an entity's Board of Directors or advisory committees; Galecto, Inc.: Consultancy; Promedior: Consultancy. Cunningham: AbbVie, Amgen, Astex, Celgene, Janssen, Novartis, Principia Biopharma, Rigel: Research Funding. Odenike: Celgene, Incyte, AstraZeneca, Astex, NS Pharma, AbbVie, Gilead, Janssen, Oncotherapy, Agios, CTI/Baxalta, Aprea: Research Funding; AbbVie, Celgene, Impact Biomedicines, Novartis, Taiho Oncology, Takeda: Consultancy. Jurcic: AbbVie, BMS/Celgene, Novartis: Consultancy; AbbVie, Arog Pharmaceuticals, Astellas, BMS/Celgene, Forma Therapeutics, Genentech, Gilead Sciences, PTC Therapeutics, Syros Pharmaceuticals: Research Funding. Nowak: Pharmaxis: Current holder of individual stocks in a privately-held company, Research Funding; AbbVie: Other: Investigator on funded clinical trial; Affimed: Research Funding; Tolero Pharma, Pharmaxis, Apogenix: Research Funding; Celgene: Honoraria; Takeda: Honoraria. Platzbecker: Janssen: Honoraria; Celgene/BMS: Honoraria; Geron: Honoraria; AbbVie: Honoraria; Novartis: Honoraria; Takeda: Honoraria. Dunshee: Genentech/Roche: Current Employment, Current equity holder in publicly-traded company. Zhou: AbbVie: Current Employment, Current holder of stock options in a privately-held company. Hoffman: AbbVie: Current Employment, Current holder of stock options in a privately-held company. Sun: AbbVie: Current Employment. Popovic: AbbVie: Current Employment, Current equity holder in publicly-traded company. Ainsworth: AbbVie: Current Employment, Current holder of stock options in a privately-held company. Naqvi: Genentech/Roche: Current Employment, Current holder of stock options in a privately-held company. Kye: AbbVie: Current Employment, Other: May hold equity. Hogdal: AbbVie: Current Employment, Current holder of stock options in a privately-held company.
Published: 2021
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68. Venetoclax and Azacitidine in the Treatment of Patients with Relapsed/Refractory Myelodysplastic Syndrome

Author: Fernando Roncolato, Ashish Bajel, David Hoffman, Daniel A. Pollyea, Jacqueline S. Garcia, Guillermo Garcia-Manero, Amer M. Zeidan, Leah Hogdal, Ying Zhou, Anne-Marie Watson, Kiran Naqvi, Steve Kye, Andrew M. Brunner, Uma Borate, Ravi Krishnadasan, Jiuhong Zha, Robin Filshie, and Olatoyosi Odenike
Subjects: Oncology, medicine.medical_specialty, business.industry, Venetoclax, Immunology, Azacitidine, Cell Biology, Hematology, Biochemistry, chemistry.chemical_compound, chemistry, Internal medicine, Relapsed refractory, medicine, business, health care economics and organizations, medicine.drug
Abstract: Introduction Patients (pts) with relapsed/refractory (R/R) higher-risk myelodysplastic syndromes (MDS) have a dismal median overall survival (OS) of 4.3 - 5.6 months (mos) and a 1-year survival probability of 28% after failure of the 2 approved hypomethylating agents (HMAs) azacitidine (Aza), and decitabine (Dec). There is no existing standard of care for pts after failure of HMA therapy; hence, there is a critical need for effective therapeutic strategies. Venetoclax (Ven) is a selective, potent, oral BCL-2 inhibitor that in combination with Aza improved clinical outcomes as frontline therapy in pts with higher-risk MDS in an early phase clinical trial. We present an updated analysis of the safety and efficacy of Ven+Aza for the treatment of pts with R/R MDS. Methods This ongoing, phase 1b, open-label, multicenter study (NCT02966782) evaluated the safety and efficacy of either Ven monotherapy or Ven+Aza combination. Pts enrolled and treated with Ven+Aza were ≥18 yrs with R/R MDS and Eastern Cooperative Oncology Group performance status ≤2. Pts were considered R/R if they received a prior therapy with no response or had a response but subsequently relapsed after receiving at least 4 cycles of Aza or Dec within the last 5 yrs. Pts were excluded if they had myelodysplastic/myeloproliferative overlap neoplasms, had prior therapy with a BH3 mimetic, or underwent allogeneic hematopoietic stem cell or solid organ transplantation. For the Ven+Aza combination, pts were treated with escalating oral doses of Ven: 100, 200, or 400 mg daily for 14 days (d) every 28-d cycle. Aza was administered at 75 mg/m 2/d on 1─7 d every cycle. Responses were assessed per modified International Working Group 2006 criteria. Results Due to limited efficacy with Ven monotherapy, this analysis focuses on outcomes in pts treated with Ven+Aza combination only. As of April 30, 2021, 44 pts were treated with Ven+Aza (male 86%, median age 74 yrs [range 44-91]). Prior to enrollment, pts received a median of 1 HMA regimen and 65% of pts received >6 cycles of HMAs. The median follow-up was 21.2 mos, range 0.4 ─ 37.5. Pts received a median of 4 cycles (range 1 ─ 32) of Ven treatment. Forty-two pts (96%) reported ≥3 grade treatment-emergent adverse events (AEs). The most common ≥3 grade hematological AEs were febrile neutropenia (34%), thrombocytopenia (32%), neutropenia (27%), and anemia (18%). Pneumonia (23%) was the most common ≥3 grade infection. Serious AEs were reported in 61%. There were 29 (66%) deaths, of which 1 (2%) occurred ≤30 d after the first Ven dose, and 3 (7%) occurred within ≤60 d of first dose. Nine (21%) deaths occurred due to disease progression, and 4 (9%) were due to AEs (gastrointestinal hemorrhage [n=1], and infections [n=3]). Twenty-one (48%) pts required Ven dose interruptions due to an AE, most frequently due to febrile neutropenia (n=7; 15%) and neutropenia (n=4; 9%). Five (11%) pts required dose duration reductions, and 9 (21%) pts required Ven discontinuation. Fifteen (34%) pts were alive at the time of data cutoff. The objective response rate (mORR, defined as complete remission [CR] + marrow CR [mCR] + partial remission [PR]) rate was 38.6%, observed in 17 pts (CR 3, mCR 14, PR 0). Median time to first response of CR or mCR was 1.2 mos (range 0.7 ─ 6.3), and the duration of response for mORR was 8.6 mos (95% CI 6.0 ─ 13.3) (Fig A). Overall median progression-free survival was 8.6 mos (95% CI 5.4 ─ 14.3) and median OS was 12.6 mos (95% CI 9.1 ─ 17.2); mOS for pts with mORR was 14.8 mos (95% CI 11.3 ─ not estimable) (Fig B). Six pts with mCR also achieved hematological improvement. Post-baseline RBC and platelet transfusion independence (TI) was achieved by 16 (36%) pts overall with a median first duration of 4.0 mos (range 1.9 ─ 8.3). Nine pts (20.5%) moved to post-study transplant. Nine pts (20.5%) progressed to acute myeloid leukemia (AML). The median time to AML progression was 4.97 mos (range 0.03 ─ 19.84), and the median time to subsequent therapy was 5.7 mos (95% CI 4.8 ─ 8.8). Conclusion With longer follow-up, the tolerability and efficacy of the Ven+Aza combination in pts with R/R MDS were consistent with what was previously reported. In a very difficult-to-treat pt population, an ORR of 39%, RBC and platelet TI rate of 36%, and a median OS of 12.6 mos all suggest that Ven+Aza treatment leads to meaningful clinical benefits. Additional analyses, including associations of genetic mutations with clinical outcomes and patient-reported outcomes, will be presented. Figure 1 Figure 1. Disclosures Zeidan: Daiichi Sankyo: Consultancy; BeyondSpring: Consultancy; Kura: Consultancy, Other: Clinical Trial Committees; ADC Therapeutics: Research Funding; Amgen: Consultancy, Research Funding; Aprea: Consultancy, Research Funding; AbbVie: Consultancy, Other: Clinical Trial Committees, Research Funding; Geron: Other: Clinical Trial Committees; Agios: Consultancy; BioCryst: Other: Clinical Trial Committees; Genentech: Consultancy; Boehringer Ingelheim: Consultancy, Research Funding; Astellas: Consultancy; Astex: Research Funding; Pfizer: Other: Travel support, Research Funding; Jazz: Consultancy; Jasper: Consultancy; Ionis: Consultancy; Epizyme: Consultancy; AstraZeneca: Consultancy; Janssen: Consultancy; Gilead: Consultancy, Other: Clinical Trial Committees; Incyte: Consultancy, Research Funding; Novartis: Consultancy, Other: Clinical Trial Committees, Travel support, Research Funding; Loxo Oncology: Consultancy, Other: Clinical Trial Committees; Cardiff Oncology: Consultancy, Other: Travel support, Research Funding; Acceleron: Consultancy, Research Funding; BMS: Consultancy, Other: Clinical Trial Committees, Research Funding. Borate: Genentech: Membership on an entity's Board of Directors or advisory committees, Other: Advisory Board; Jazz Pharma: Research Funding; Daiichi-Sankyo: Membership on an entity's Board of Directors or advisory committees; Pfizer: Membership on an entity's Board of Directors or advisory committees, Research Funding; Novartis: Membership on an entity's Board of Directors or advisory committees, Research Funding; AbbVie: Membership on an entity's Board of Directors or advisory committees, Research Funding; Takeda: Membership on an entity's Board of Directors or advisory committees; Blueprint Medicine: Membership on an entity's Board of Directors or advisory committees; Astellas: Membership on an entity's Board of Directors or advisory committees; incyte: Membership on an entity's Board of Directors or advisory committees, Research Funding; Rampal: Membership on an entity's Board of Directors or advisory committees; Galecto, Inc.: Consultancy; Promedior: Consultancy. Pollyea: Jazz: Honoraria, Membership on an entity's Board of Directors or advisory committees, Other: advisory board; Bristol Myers Squibb: Honoraria, Membership on an entity's Board of Directors or advisory committees; Kiadis: Honoraria, Membership on an entity's Board of Directors or advisory committees; Novartis: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees; Syndax: Honoraria, Membership on an entity's Board of Directors or advisory committees; Syros: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees; Takeda: Honoraria, Membership on an entity's Board of Directors or advisory committees, Other; Teva: Research Funding; Curis, Servier: Other; Pfizer: Research Funding; Agios: Other, Research Funding; Karyopharm: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees; Gilead: Consultancy, Honoraria, Other: advisory board; Astellas: Honoraria, Membership on an entity's Board of Directors or advisory committees; Foghorn: Honoraria, Membership on an entity's Board of Directors or advisory committees; Amgen: Honoraria; AbbVie: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees, Research Funding; Celgene: Honoraria, Other: advisory board; Aprea: Honoraria, Membership on an entity's Board of Directors or advisory committees; Genentech: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees. Brunner: Celgene, Forty Seven Inc, Jazz: Other: Advisory Board; Novartis, Celgene, Takeda, AstraZeneca: Research Funding. Roncolato: AbbVie: Other: Investigator in AbbVie funded Clinical Trials. Garcia: AstraZeneca: Research Funding; Pfizer: Research Funding; Prelude: Research Funding; Genentech: Research Funding; Takeda: Consultancy, Membership on an entity's Board of Directors or advisory committees; Astellas: Consultancy, Membership on an entity's Board of Directors or advisory committees; AbbVie: Consultancy, Membership on an entity's Board of Directors or advisory committees, Research Funding. Odenike: Celgene, Incyte, AstraZeneca, Astex, NS Pharma, AbbVie, Gilead, Janssen, Oncotherapy, Agios, CTI/Baxalta, Aprea: Research Funding; AbbVie, Celgene, Impact Biomedicines, Novartis, Taiho Oncology, Takeda: Consultancy. Watson: Astellas Pharma, Inc.: Consultancy; Roche, Amgen: Other: Travel support. Krishnadasan: AbbVie: Other: Investigator in AbbVie funded Clinical Trials. Bajel: Amgen: Speakers Bureau; Abbvie, Amgen, Novartis, Pfizer: Honoraria. Naqvi: Genentech/Roche: Current Employment, Current holder of stock options in a privately-held company. Zha: AbbVie: Current Employment, Current holder of stock options in a privately-held company. Hogdal: AbbVie: Current Employment, Current holder of stock options in a privately-held company. Zhou: AbbVie: Current Employment, Current holder of stock options in a privately-held company. Hoffman: AbbVie: Current Employment, Current holder of stock options in a privately-held company. Kye: AbbVie: Current Employment, Other: May hold equity. OffLabel Disclosure: Venetoclax is a BCL-2 inhibitor that is FDA approved for multiple indications. Venetoclax is not currently approved for the treatment of myelodysplastic syndrome. Azacitidine is FDA approved for continued treatment of adult patients with acute myeloid leukemia who achieved first complete remission or complete remission with incomplete blood count recovery following intensive induction chemotherapy and are not able to complete intensive curative therapy.
Published: 2021
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69. 448 Lemzoparlimab (TJ011133), an anti-CD47 antibody, with/without dexamethasone plus anti-myeloma regimens for relapsed/refractory multiple myeloma: a phase 1b dose escalation and expansion study

Author: Jose Cordero, Kevin Wu, Gregory Monohan, Cristina Gasparetto, Andrew Yee, Orlando F. Bueno, Moshe Etzion Gatt, Lionel Karlin, Katja Weisel, Edward A. Stadtmauer, David Hoffman, Shayna Rockow-Magnone, and Ankit Kansagra
Subjects: Pharmacology, Cancer Research, biology, business.industry, CD47, Immunology, medicine.disease, Oncology, Relapsed refractory, Dose escalation, biology.protein, medicine, Cancer research, Molecular Medicine, Immunology and Allergy, Antibody, business, Dexamethasone, Multiple myeloma, medicine.drug
Abstract: BackgroundDespite therapeutic advancements for multiple myeloma (MM), most patients with MM develop relapsed/refractory (R/R) disease, which is associated with high mortality and highlights an unmet need for novel treatments.A key characteristic of MM cells is the overexpression of CD47, which downregulates phagocytosis, thereby allowing malignant plasma cells to evade destruction by the immune system. Blocking CD47 with lemzoparlimab, an anti-CD47 monoclonal antibody, may enhance macrophage-mediated anti-tumor activity.This study will characterize the safety, dose-limiting toxicity, and recommended dosing of lemzoparlimab (TJ011133) with or without dexamethasone and combined with other anti-myeloma regimens in patients with R/R MM.MethodsThis phase 1b, open-label, dose-escalation and expansion study (NCT04895410) will enroll adults with R/R MM, an Eastern Cooperative Oncology Group Performance Status ≤2, prior treatment history (varies based on treatment arm; Figure 1), and measurable disease (serum monoclonal paraprotein [M-protein] ≥0.5 g/dL, urine M-protein ≥200 mg/24 hours, or serum-free light chain ≥100 mg/L).Patients will be enrolled in 2 phases (escalation and expansion), divided into 4 arms to receive treatment in 28-day cycles (figure 1): (A) lemzoparlimab ± dexamethasone; (B) lemzoparlimab + dexamethasone + pomalidomide (4 mg orally daily [Days 1–21]); (C) lemzoparlimab + dexamethasone + carfilzomib (56 mg/m2 intravenously, 6 doses/cycle [first 2 doses in Cycle 1: 20 mg/m2]); and (D) lemzoparlimab + dexamethasone + daratumumab (1800 mg subcutaneously [Cycle 1, start on Day 2; Cycles 1–2, once weekly; Cycles 3–6, every 2 weeks; Cycles ≥7, Day 1]). Dexamethasone will be administered orally twice weekly at 20 mg for Arm C, and orally or intravenously weekly at 40 mg for other arms. Dose escalation will follow Bayesian optimal interval design. Once maximum tolerated dose/recommended phase 2 dose (RP2D) is determined, patients will be enrolled in the expansion. Treatment discontinuation criteria are: unacceptable toxicity, disease progression, consent withdrawal, or investigator’s discretion.The primary endpoint is determination of the RP2D. Secondary endpoints include safety and efficacy measures. Time-to-event endpoints will be analyzed using the Kaplan–Meier method.AcknowledgementsAbbVie is funding this study and participating in the study design, research, analysis, data collection, interpretation of data, reviewing, and approval of the publication. All authors had access to relevant data and participated in the drafting, review, and approval of this publication. No honoraria or payments were made for authorship.Medical writing support was provided by Marta Rossi, PhD, of Fishawack Communications Ltd, and funded by AbbVie.Trial RegistrationClinicalTrials.gov: NCT04895410Ethics ApprovalThe protocol, informed consent form(s), recruitment materials, and all patient materials will be submitted to the Independent Ethics Committee/Institutional Review Board for review and approval.Abstract 448 Figure 1Study schematicThe dose escalation phase will follow BOIN; it will start with lemzoparlimab (TJ011133) monotherapy at DL1 in Arm A. If DL1 is not tolerated as monotherapy or as combination therapy, DL −1 will be evaluated. Investigation of combination arms will start after evaluation of monotherapy.Arms A, B, C and D will include patients with R/R MM after progressing on defined therapies and number of prior lines of therapy.BOIN, Bayesian optimal interval; DL, dose level; MM, multiple myeloma; R/R, relapsed/refractory.
Published: 2021
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70. Safety and Efficacy of Thrombin-JMI: A Multidisciplinary Expert Group Consensus

Author: Bhandari, Mohit, Ofosu, Frederick A., Mackman, Nigel, Jackson, Craig, Doria, Cataldo, Humphries, John E., Babu, Sateesh C., Ortel, Thomas L., Van Thiel, David Hoffman, Walenga, Jeanine M., Wahi, Rakesh, To Teoh, Kevin Hong, and Fareed, Jawed
Published: 2011
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71. Poster: MDS-158: Updated Safety and Efficacy of Venetoclax in Combination with Azacitidine for the Treatment of Patients with Treatment-Naïve, Higher-Risk Myelodysplastic Syndromes: Phase 1b Results

Author: Andrew H. Wei, Jacqueline S. Garcia, Uma Borate, Chun Yew Fong, Maria R Baer, Daniel Nowak, Pierre Peterlin, Joseph Jurcic, Meagan A. Jacoby, Uwe Platzbecker, Olatoyosi Odenike, Ilona Cunningham, Ying Zhou, David Hoffman, Leah Hogdal, Kiran Naqvi, Steve Kye, and Guillermo Garcia-Manero
Subjects: Cancer Research, Oncology, Hematology
Published: 2021
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72. MDS-158: Updated Safety and Efficacy of Venetoclax in Combination with Azacitidine for the Treatment of Patients with Treatment-Naïve, Higher-Risk Myelodysplastic Syndromes: Phase 1b Results

Author: Joseph G. Jurcic, Ilona Cunningham, Maria R. Baer, Olatoyosi Odenike, Guillermo Garcia-Manero, Kiran Naqvi, Uma Borate, David Hoffman, Steve Kye, Uwe Platzbecker, Meagan A. Jacoby, Pierre Peterlin, Leah Hogdal, Andrew H. Wei, Ying Zhou, Chun Yew Fong, Jacqueline S. Garcia, and Daniel Nowak
Subjects: Cancer Research, medicine.medical_specialty, business.industry, Nausea, Venetoclax, Myelodysplastic syndromes, Azacitidine, Hematology, Neutropenia, medicine.disease, Gastroenterology, chemistry.chemical_compound, Oncology, chemistry, International Prognostic Scoring System, Internal medicine, medicine, medicine.symptom, Adverse effect, business, Febrile neutropenia, medicine.drug
Abstract: Background: Venetoclax (Ven), a selective oral BCL-2 inhibitor, demonstrated synergy with azacitidine (Aza) in patients with higher-risk myelodysplastic syndromes (HR-MDS). Objective: We report updated safety and efficacy in an ongoing phase 1b study (NCT02942290) evaluating Ven+Aza for treatment-naive HR-MDS patients. Methods: Patients (≥18yrs) with International Prognostic Scoring System (IPSS) intermediate-2 or high-risk MDS, bone marrow (BM) blasts Main Outcomes Measures: Primary objectives were assessing Ven+Aza safety profile and establishing RP2D. Key secondary objectives included overall response rate (ORR) and overall survival (OS). Results: At data cutoff (Dec. 15, 2020), 78 patients received Ven+Aza (51 at RP2D 400 mg x 14 d), with median follow-up time of 23 mos. Median age was 70 yrs; 72% male; 90% had excess BM blasts (>5 to 10%, n=21; >10 to 20%, n=49). Grade 3/4 neutropenia (59%) or thrombocytopenia (33%) were present at baseline. All patients experienced ≥1 treatment-emergent adverse event (TEAE), the most common being neutropenia (83%), nausea (55%), and constipation (54%); 96% experienced grade 3/4 TEAEs, with neutropenia (82%), febrile neutropenia (49%), and thrombocytopenia (42%) being most common. Neutropenia (49%), including febrile neutropenia (45%), was the most common serious TEAE. The 30-d mortality rate after first dose was 1%. Intention-to-treat ORR was 80%, including complete remission (CR,40%) and marrow CR (mCR, 40%); 42% mCR had hematologic improvement; no partial remissions recorded. For 31 CR patients, median time to CR and median duration of response was 2.6 and 13.8 mos (95% CI 8.9,–), respectively. Post-baseline transfusion independence rate (defined as no transfusion ≥8 weeks), for patients transfusion-dependent for RBC and/or platelets at baseline, was 46.5%. Median OS was 28.2 mos (95% CI 17.7, –). Median OS for 31 patients achieving CR was 28.6 mos (95% CI 27.5, –). Twenty-three percent moved on to post-study allogeneic HSCT (including BM and peripheral blood stem cells). Conclusions: The combination of Ven+Aza was associated with rapid and durable response, promising efficacy, including remission rates and OS, and an acceptable safety profile for patients with HR-MDS. Additional correlation with disease risk features, including TP53 mutations, will be presented.
Published: 2021
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73. Abstract 641: Clinical assessment of the bioavailability of venetoclax tablet and powder formulations

Author: Su Young Kim, Xin Chen, Bo Tong, David Hoffman, Mohamed Badawi, Tammy Palenski, Rajeev M. Menon, Ahmed Salem, and Divya Samineni
Subjects: Cancer Research, Traditional medicine, Venetoclax, business.industry, Cmax, Difficulty swallowing, Bioequivalence, Bioavailability, chemistry.chemical_compound, Oncology, chemistry, Oral suspensions, Medicine, business
Abstract: Venetoclax is a first in class BCL-2 inhibitor that is approved for treatment of CLL and AML. It is currently under evaluation in other indications in adult and pediatric populations. Venetoclax is available as 10 mg, 50 mg, and 100 mg film-coated tablets. While the 100 mg tablet is most commonly used, the smaller size of the lower strength tablets is preferred by patients experiencing difficulty swallowing large tablets. Moreover, two powder formulations for suspension (0.72% and 7.2%) to be mixed with delivery vehicles were developed. In this abstract we present data from clinical studies that evaluated the bioavailability of the different venetoclax formulations relative to the commercially available 100 mg tablet. Three open-label, single-dose, crossover bioavailability studies in healthy female subjects were conducted. The first study evaluated the bioavailability of the commercially available 10 and 50 mg tablets relative to the 100 mg tablet. Forty subjects received a 100 mg dose of venetoclax (1x100 mg tablet, 2x50 mg tablets or 10x10 mg tablets) at the start of each period after a low-fat breakfast. The second study evaluated the bioavailability of the two powder formulations relative to the 100 mg tablet. Sixteen subjects received a 100 mg dose of venetoclax (1x100 mg film-coated tablet; 100 mg 0.72% powder formulation; 100 mg 7.2% powder formulation; and 4x25 mg dispersible tablets for oral suspension used in the Phase 1 study) in each of the 4 periods after a high fat breakfast. The third study evaluated the bioavailability of the two powder formulations when administered with different dosing vehicles relative to water. Twenty-four subjects (12 per cohort) received 100 mg of venetoclax (0.72% powder formulation or the 7.2% powder formulation) with either water, apple juice, apple sauce or yogurt in each of the 4 periods after a moderate fat breakfast. Bioavailability assessment of the commercial tablets demonstrated that ten 10 mg tablets were bioequivalent to one 100 mg tablet, two 50 mg tablets were bioequivalent to one 100 mg tablet, and two 50 mg tablets were bioequivalent to ten 10 mg tablets. The two powder formulations for oral suspension (0.72% and 7.2%) met the bioequivalence criteria (0.80-1.25) to the commercial 100 mg tablet with respect to AUCt and AUC∞, but the lower bound of the 90% CI of the Cmax extended slightly below 0.80. The delivery vehicles (water, apple juice, apple sauce and yogurt) did not affect the bioavailability of venetoclax 0.72% or 7.2% oral suspensions Citation Format: Mohamed Badawi, Bo Tong, Xin Chen, Tammy Palenski, Su Young Kim, Divya Samineni, David Hoffman, Rajeev Menon, Ahmed Hamed Salem. Clinical assessment of the bioavailability of venetoclax tablet and powder formulations [abstract]. In: Proceedings of the American Association for Cancer Research Annual Meeting 2021; 2021 Apr 10-15 and May 17-21. Philadelphia (PA): AACR; Cancer Res 2021;81(13_Suppl):Abstract nr 641.
Published: 2021
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74. T1 mapping, T2 mapping and MR elastography of the liver for detection and staging of liver fibrosis

Author: Fei Han, Krishna Shanbhogue, David Hoffman, Dominik Nickel, Abimbola Ayoola, and Hersh Chandarana
Subjects: Adult, Liver Cirrhosis, Male, Urology, Liver fibrosis, T2 mapping, Biopsy, 030218 nuclear medicine & medical imaging, 03 medical and health sciences, Liver disease, 0302 clinical medicine, Fibrosis, Liver stiffness, medicine, Humans, Radiology, Nuclear Medicine and imaging, Aged, Retrospective Studies, Aged, 80 and over, Radiological and Ultrasound Technology, medicine.diagnostic_test, business.industry, Gastroenterology, Fibrosis stage, Middle Aged, medicine.disease, Magnetic Resonance Imaging, 030220 oncology & carcinogenesis, Liver biopsy, Elasticity Imaging Techniques, Female, Elastography, Nuclear medicine, business
Abstract: To compare liver stiffness measurements obtained from MR elastography with liver T1 relaxation times obtained from T1 mapping and T2 relaxation times obtained from T2 mapping for detection and staging of liver fibrosis. 223 patients with known or suspected liver disease underwent MRI of the liver with T1 mapping (Look-Locker sequence) and 2D SE-EPI MR elastography (MRE) sequences. 139 of these patients also underwent T2 mapping with radial T2 TSE sequence. Two readers (R1 & R2) measured liver stiffness, T1 relaxation times and T2 relaxation times. T1 and T2 times were correlated with stiffness measurements. ROC analysis was used to compare the performance of both techniques in discriminating fibrosis stage in 23 patients who underwent liver biopsy. For each reader there was significant moderate positive correlation between liver MRE and liver T1 mapping (r = 0.49 and 0.36). There was significant moderate positive correlation between liver T2 mapping and each of MRE and T1 mapping for one of the readers (r = 0.40 and 0.27). AUC for differentiating early (F0–F2) from advanced (F3–F4) fibrosis in biopsied patients was 0.975 (R1) and 0.925 (R2) for MRE, 0.671 (R1) and 0.642 (R2) for T1 mapping and 0.671 (R1) and 0.743 (R2) for T2 mapping. Inter-reader agreement was good for MRE (ICC = 0.84) substantial for T1 mapping (0.94) and T2 mapping (0.96). Liver T1 and T2 mapping showed moderate positive correlation with MR elastography. Accuracy of MRE is however superior to T1 and T2 mapping in the subset of patients who underwent liver biopsy. Accuracy of combination of MRE and T1 mapping/T2 mapping was not superior to MRE alone.
Published: 2019

75. Correction to: Graphical translators for mean curvature flow

Author: Brian White, David Hoffman, Francisco Martin, and Tom Ilmanen
Subjects: Mean curvature flow, TheoryofComputation_MATHEMATICALLOGICANDFORMALLANGUAGES, Applied Mathematics, Calculus, High Energy Physics::Experiment, Astrophysics::Earth and Planetary Astrophysics, GeneralLiterature_REFERENCE(e.g.,dictionaries,encyclopedias,glossaries), Computer Science::Digital Libraries, Astrophysics::Galaxy Astrophysics, Analysis, Mathematics
Abstract: In the online published article, the reference cited at the end of the proof of Theorem 5.1 was published incorrectly.
Published: 2019
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76. Ticagrelor in patients with diabetes and stable coronary artery disease with a history of previous percutaneous coronary intervention (THEMIS-PCI): a phase 3, placebo-controlled, randomised trial

Author: Deepak L Bhatt, Philippe Gabriel Steg, Shamir R Mehta, Lawrence A Leiter, Tabassome Simon, Kim Fox, Claes Held, Marielle Andersson, Anders Himmelmann, Wilhelm Ridderstråle, Jersey Chen, Yang Song, Rafael Diaz, Shinya Goto, Stefan K James, Kausik K Ray, Alexander N Parkhomenko, Mikhail N Kosiborod, Darren K McGuire, Robert A Harrington, Vladimir Santos, Ashit Jain, Irina Lendel, Michael Russo, W H Haught, Manuel Bouza, Harinder Gogia, Supratim Banerjee, George Kichura, Louis Kantaros, Francisco Padron, Rakesh Passi, Jay Stone, Michael Pursley, Michael D'Urso, Timothy Gardner, James Bennett, Khaled Nour, Satinder Saini, Wenwu Zhang, Dharam Kumbhani, Dustin Thomas, Dominick Angiolillo, Barry Bertolet, Amaury Roman-Miranda, Robert Black, Ramin Manshadi, Carlos Vaca, Antonio Blanco, Mark Napoli, David Brabham, Ayim Akyea-Djamson, Pratik Desai, Sudhir Prasada, Ajit Khaira, Leslie Forgosh, Ira Lieber, Guillermo Umpierrez, Dinesh Singal, Juan Londono, Neil Fraser, Jose Ruiz, Damaris Vega, Lilia Rodriguez, Christopher Brown, Faizullah Syed, Guarav Aggarwala, William Eaves, Michael Foster, Dinesh Gupta, David Avino, Wail Asfour, Glen Tonnessen, Xue-Qiao Zhao, Narendra Singh, Andrew Brockmyre, Norman Lepor, Nicolas Shammas, David Blick, Steven Hearne, John Prodafikas, Edgar Carell, Mark Izzo, Amin Karim, Bosh Zakhary, Mahmoud Atieh, Steven Leichter, Charles Meadows, David Hotchkiss, Mazen Abu-Fadel, Alan Wiseman, Jeffrey Bander, Mahesh Shah, Subhash Banerjee, Ricky Ganim, Karen Sopko, Misal Khan, Ramon Lloret, Troy Weirick, Rajendra Mehta, Udho Thadani, Anuj Bhargava, Mikhail Kosiborod, Jaynier Moya, Cezar Staniloae, Yamirka D Guerra, Anil Chhabra, Douglas Kosmicki, Wassim Shaheen, Akber Mohammed, J'Cinda Bitters, Jan Pattanayak, Julian Javier, Sunny Srivastava, Roland Phillips, Jessie Al-Amin, Michael Lillestol, Patrick Simpson, Lydie Hazan, Amit Amin, Gopi Shah, Denes Korpas, Bruce Platt, Jim Dickert, Orlando Puente, Louis Hiotis, Timothy Doyle, Raj Rajan, Alan Meholick, Christian Gring, Elie Hage-Korban, Robert Feldman, Harry Colfer, Samuel Butman, Malcolm Foster, Terence Hart, Randall Huling, Shervin Eshaghian, Ofsman Quintana, Deanna Cheung, Franklin Handel, Mara Rodriguez, David Suh, Paul Gordon, Gregg Pressman, Michael Bauer, William French, Mark Barettella, Sridhar Chatrathi, Damodhar Suresh, Ronald Goldberg, Mark Huth, Liwa Younis, Aref Rahman, Richard Mascolo, Michelle Welch, Randeep Suneja, Stephen Smith, Scott Shurmur, John Agaiby, Ahmad Jingo, Janice Johnston, Mary Beth, Anthony Vlastaris, Susan Kemp, Hamid Taheri, Edward Pereira, Michael Deyoung, Zafir Hawa, Ray Smith, Thomas Galski, Samer Garas, M Reddy, Susheel Sharma, Joeseph Hargrove, Charles Treasure, Ronald Emerson, Tariq Haddad, Kathryn Rohr, Larry Levinson, Raul Gaona, Barry Uretsky, Hiralal Maheshwari, Denny Lee, Stephanie Kinnaman, Robert Singal, Jeffrey Geohas, Osvaldo Gigliotti, Ajit Raisinghani, Charanjit Khurana, Brent Hella, Michael Kelberman, Steven Voyce, Sanjay Singh, Eric Lo, Pradeep Singh, Ross Goodfellow, Stuart Fischer, Richard Lorraine, Traci Turner, Jeffrey Shanes, Robert Busch, Robert Broker, Michelle Zaniewski, Kevin Pounds, Giselle Debs-Perez, Stephen Ong, Brad Frandsen, Douglas Fullington, Naseem Jaffrani, Ahtaram Khan, Marcus Lee, Joe Pouzar, George Revtyak, Julian Gonzalez, Samer Nakhle, Abel Murillo, Douglas Young, Sashi Makam, Mushtaq Syed, Kevin Woolf, Paul Grena, Sarab Alfata, Sharan Mahal, David Hoffman, Tinoy Kizhakekuttu, Joseph Deering, Janak Bhavsar, Scott Mikesell, William Wilson, Vance Wilson, Salah El, Francis Spinale, Vinod Kannarkat, Sunder Rao, Lenita Hanson, John Bertsch, Elena Gonzalez-Ortiz, Norma Severino, John Willis, Joel Schock, Ladan Bakhtari, Raul Gazmuri, Saadat Ansari, Jason Hall, Arvind Mehta, Neal Shealy, Stuart Zarich, Deovrat Singh, Kishor Vora, Nabil Andrawis, Darron Molter, David Maron, Jose Cardona, Ronald D'Agostino, Tamjeed Arshad, Rodney Samaan, David Jones, Dale Presser, John Heath, Sandy Green, George Bittar, Sheldon Henry, David Korn, John Schmedtje, Venkatesh Nadar, Bruce Graham, Ajay Labroo, Leonardo Clavijo, Hal Roseman, Gilbert Ledesma, Robert Rosen, Isaac Dor, William Kirby, Jennefer Sutton, Frank Eder, Bruce Iteld, Jose Gomez-Cortes, Maurice Buchbinder, Joseph Kasper, Antonio Terrelonge, Gustavo Torres, Ted Jagielo, Jose Alvarez, Yehuda Handelsman, Mario Guillen, Randall Richwine, Lorena Lewy-Alterbaum, Clinton Corder, Moogali Arvind, David Bolshoun, Magdy Mikhail, Stephen Minton, Odilon Alvarado, J Abbott, Brett Cauthen, Ryan Welter, Randy Mintz, John Cox, Annette Quick, Melvin Weiss, Johnny Dy, James Zebrack, Glenn Gandelman, Vinayak Hegde, Marc Silver, Michele DeGregorio, William Lawson, Christopher Paa, Anna Bortnick, Merrill Krolick, Rodolfo Sotolongo, Jorge Cheirif, Priya Kumar, Preetham Jetty, Ambar Patel, Mariusz Kruk, Iwona Kobielusz-Gembala, Barbara Rewerska, Adam Madrzejewski, Krzysztof Milewski, Jerzy Cygler, Joanna Petryka-Mazurkiewicz, Waldemar Jastrzebski, Janusz Korecki, Wojciech Fil, Janusz Prokopczuk, Anna Bochenek, Marek Wujkowski, Robert Witek, Piotr Konczakowski, Pawel Miekus, Marcin Szczasny, Wlodzimierz Musial, Krzysztof Cymerman, Jacek Lampart, Jacek Mikosinski, Slawomir Szynal, Issa Fares, Grzegorz Opolski, Stanislaw Mazur, Beata Wozakowska-Kaplon, Renata Bijata-Bronisz, Lukasz Wierucki, Beata Losa, Grzegorz Drelich, Marek Konieczny, Pawel Starczewski, Lidia Pawlowicz, Pawel Jesionowski, Jaroslaw Jurowiecki, Jacek Gniot, Mariusz Czyzycki, Karol Stania, Izabela Kucharczyk-Bauman, Benita Busz-Papiez, Agnieszka Karczmarczyk, Wanda Sudnik, Alina Koszek, Piotr Kolodziej, Bartosz Skwarna, Nicolás Jaramillo, Maciej Jankowski, Wojciech Czochra, Leszek Kinasz, Beata Miklaszewicz, Teresa Stasinska, Wladyslaw Pluta, Marcin Basiak, Teresa Rusicka, Izabela Niedbal-Yahfouf, Grazyna Popenda, Romuald Korzeniak, Agnieszka Mirek, Rafal Mariankowski, Lukasz Wojnowski, Marek Korol, Jacek Baszak, Piotr Podolec, Wojciech Piesiewicz, Aleksander Zurakowski, Carlos Luengas, Marek Skura, Piotr Pilecki, Piotr Majchrzak, Ewa Krzyzagórska, Marcin Drozd, Barbara Kaczmarek, Teresa Sliwinska, Katarzyna Zelazowska, Rafal Sztembis, Katarzyna Landa, Lidia Matyszczak-Toniak, Krzysztof Strojek, Marek Piepiorka, Robert Malinowski, Maria Górska, Edyta Stolarczyk-Sowa, Leszek Romanowski, Elzbieta Zinka, Zygfryd Reszka, Joanna Skierkowska, Anna Uzunow, Ewa Laskowska-Derlaga, Ekaterina Puntus, Elena D Kosmacheva, Natalia Koziolova, Prokhor Pavlov, Tatiana Supryadkina, Yury Didenko, Philipp Kopylov, Andrei Kazakov, Sergei Aksentiev, Elena Vishneva, Alexey Repin, Olga Smolenskaya, Olga Mantserova, Oleg Khrustalev, Elena Privalova, Vladimir Konstantinov, Svetlana Boldueva, Andrey Ezhov, Alexander Chernyavsky, Gadel Kamalov, Albert Galyavich, Galina Zubeeva, Galina Nechaeva, Sergey Shustov, Nino Dzhaiani, Tatiana Treshkur, Nataliya Osokina, Alexey Panov, Elena Shutemova, Valeriy Makukhin, Tatiana Kropotina, Larisa Tsyba, Yuri Karpov, J M Sizova, Marina Ballyuzek, Nikolay Tarasov, Elena Demchenko, Olga Barbarash, Valentin Moiseev, Valentin Markov, Vadim Kuznetsov, Inna Viktorova, Igor Sergienko, Lyudmila Ermoshkina, Niyaz Khasanov, Tatiana Khlevchuk, Andrey Baglikov, Sergey Shalaev, Elena Zonova, Elena Reznik, Larisa Haisheva, Tatyana Morugova, Nikita Lomakin, Alexander Vishnevsky, Yuri Shvarts, Olga Magnitskaya, Marina Mikhailusova, Elena Pavlysh, Igor Libov, Anna Zateyschikova, Victor Kostenko, Anton Edin, Yaroslava Khovaeva, Konstantin Zakharov, Raisa Stryuk, Vladimir Khirmanov, Sergey Kanorskiy, Sergey Yakushin, Anna Barabashkina, Hongwei Li, Qiang Zhao, Jian Zhang, Jianhua Ma, Yong He, Ming Luo, Aidong Zhang, Ningru Zhang, Yingru Chai, Genshan Ma, Hao Wang, Zhigang Liu, Lanjie He, Zhifang Song, Xiaolin Dong, Liang Tao, Zhanquan Li, Xi Su, Xiangqing Kong, Heping Niu, Junbo Ge, Zhurong Luo, Wenjun Huang, Daoquan Peng, Zuyi Yuan, Maria Milanova, Doncho Tenev, Antoni Gogov, Dimitar Karageorgiev, Todor Kolchev, Nikolay Rusev, Nikolina Georgieva, Rumen Kondov, Veselin Rusinov, Ivo Petrov, Georgi Stanchev, Mariana Konteva, Adriana Dincheva, Zdravka Yaneva, Ralitsa Vatova, Katya Ilieva, Nikolai Runev, Borislav Kolomanov, Ivan Petrov, Nikolay Iliev, Snezhanka Tisheva, Boryana Chompalova, Maria Tokmakova, Dimitar Raev, Kolyo Byanov, Dimitar Markov, Lenko Mihov, Atanas Mihov, Nora Milcheva, Milen Minchev, Mihail Mollov, Borislav Borisov, Tihomir Tihchev, Venelin Karakolev, Bojidar Dimov, Svetoslav Georgiev, Lachezar Smilov, Bon K Koo, Taehoon Ahn, Soon J Hong, Junghan Yoon, Seok K Oh, Myung H Jeong, Doo-Il Kim, Kiyuk Chang, Weon Kim, Joo-Yong Hahn, Kwang S Cha, Jung-Hee Lee, Si-Wan Choi, Chang-Wook Nam, In-Ho Chae, Yong H Park, Seung-Jea Tahk, Won-Yong Shin, Jei-Keon Chae, Byung J Kim, Jang-Whan Bae, Woo J Park, Seung W Rha, Young J Choi, Jin-Yong Hwang, Hun S Park, Luciano Baracioli, Fabio Guimaraes, Eduardo Vasconcellos, José Saraiva, Adamastor Pereira, Queulla Santos, Paulo Rossi, Lilia Maia, Miguel Madeira, Marcio Pereira, Roberto Botelho, Gilmar Reis, Freddy Eliaschewitz, Joao Borges, Carlos Nascimento, Jose A Fortes, Weimar de Souza, Pedro Pimentel, Miguel Hissa, Marcos Franchetti, Dalton Precoma, Costantino Ortiz, Mauro Hernandes, Wladmir Saporito, Fabio R dos Santos, Adrian Kormann, Fernando Neuenschwander, Oscar Dutra, Nelson Rassi, Luiz Tanajura, Juliana Souza, Delcio S Junior, Paulo Leaes, Adriana Forte, Teresa C Bonansea, Jose Marin, Bruno Machado, Maria J Cerqueira, Frederico Silva, Yorghos Michalaros, Euler Manenti, Cintia Cercato, Estevao Figueiredo, Ming-En Liu, Yi-Chih Wang, Tsung-Ming Lee, Chih Fang, Yen-Wen Wu, Kwo-Chang Ueng, Huey-Herng Sheu, Wen T Lai, I-Chang Hsieh, Zhih-Cherng Chen, Mu-Jang Lee, Chern Chiang, Kou-Gi Shyu, Chien-Hsun Hsia, Guang-Yuan Mar, Shih-Hung Chan, Chih-Cheng Wu, Wei-Kung Tseng, Kuan-Cheng Chang, Hung-I Yeh, Ji-Hung Wang, Charles Hou, Inna Sorokina, Maryna Dolzhenko, Olha Horoshko, Oleksandr Karpenko, Leonid Rudenko, Igor Vakaliuk, Anna Kulyk, Olena Levchenko, Oleksandr Prokhorov, Dmytro Reshotko, Mykhaylo Sorokivskyy, Nataliia Velichko, Valentyn Maslovskyi, Zinaida Teliatnikova, Sergiy Dotsenko, Olena Krakhmalova, Igor Kraiz, Viktoria Zharinova, Larysa Bula, Igor Kaydashev, Valeriy Molodtsov, Lesya Rasputina, Viktoriya Pidlisna, Olena Lysunets, Anatoliy Kravchenko, Liubomyr Glushko, Tetyana Khomazyuk, Yevgeniya Svyshchenko, Oleksandr Parkhomenko, Boris Mankovsky, Orest Abrahamovych, Andriy Yagensky, Mykola Stanislavchuk, Larisa Vasilyeva, Liubov Sokolova, Oleg Sychov, Vira Tseluyko, Igor Kyrychenko, Mykola Rishko, Sergiy Furkalo, Richard Gallo, Olivier Bertrand, Shamir Mehta, Christian Constance, Bruce Sussex, Remo Zadra, Simon Kouz, Raja Chehayeb, Amritanshu Pandey, Danielle Dion, Gordon Bailey, Laurie Hill, Krishnan Ramanathan, Micha Dorsch, Alykhan Nanji, Mohan Babapulle, Martine Montigny, Gilbert Gosselin, Payam Dehghani, Dennis Rupka, Michel Le May, Francis Pichette, Francois St-Maurice, Patrick Teefy, Samer 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Chern-En Chiang, Alexander Parkhomenko, Tuan Q Nguyen, Maria Leonsson-Zachrisson, Herrada, Anthony, Brigham & Women’s Hospital [Boston] (BWH), Harvard Medical School [Boston] (HMS), AP-HP - Hôpital Bichat - Claude Bernard [Paris], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP), Laboratoire de Recherche Vasculaire Translationnelle (LVTS (UMR_S_1148 / U1148)), Université Paris 13 (UP13)-Université Paris Diderot - Paris 7 (UPD7)-Institut National de la Santé et de la Recherche Médicale (INSERM), Royal Brompton Hospital, McMaster University [Hamilton, Ontario], Keenan Research Centre of the Li Ka Shing Knowledge Institute [Toronto], St. Michael's Hospital, University of Toronto, Service de Pharmacologie médicale = service de pharmacologie - Dosage de médicaments [CHU Saint-Antoine], CHU Saint-Antoine [AP-HP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU), Sorbonne Université (SU), National Heart and Lung Institute [London] (NHLI), Imperial College London-Royal Brompton and Harefield NHS Foundation Trust, Uppsala University Hospital, Uppsala Universitet [Uppsala], AstraZeneca, Tokai University, Uppsala University, Imperial College London, Saint Luke's Mid America Heart Institute, University of Missouri [Kansas City] (UMKC), University of Missouri System, University of New South Wales [Sydney] (UNSW), University of Texas Southwestern Medical Center [Dallas], Stanford University, Centre Hospitalier Universitaire de Nîmes (CHU Nîmes), Université de Montpellier (UM), Bhatt, D, Steg, P, Mehta, S, Leiter, L, Simon, T, Fox, K, Held, C, Andersson, M, Himmelmann, A, Ridderstrale, W, Chen, J, Song, Y, Diaz, R, Goto, S, James, S, Ray, K, Parkhomenko, A, Kosiborod, M, Mcguire, D, Harrington, R, Santos, V, Jain, A, Lendel, I, Russo, M, Haught, W, Bouza, M, Gogia, H, Banerjee, S, Kichura, G, Kantaros, L, Padron, F, Passi, R, Stone, J, Pursley, M, D'Urso, M, Gardner, T, Bennett, J, Nour, K, Saini, S, Zhang, W, Kumbhani, D, Thomas, D, Angiolillo, D, Bertolet, B, Roman-Miranda, A, Black, R, Manshadi, R, Vaca, C, Blanco, A, Napoli, M, Brabham, D, Akyea-Djamson, A, Desai, P, Prasada, S, Khaira, A, Forgosh, L, Lieber, I, Umpierrez, G, Singal, D, Londono, J, Fraser, N, Ruiz, J, Vega, D, Rodriguez, L, Brown, C, Syed, F, Aggarwala, G, Eaves, W, Foster, M, Gupta, D, Avino, D, Asfour, W, Tonnessen, G, Zhao, X, Singh, N, Brockmyre, A, Lepor, N, Shammas, N, Blick, D, Hearne, S, Prodafikas, J, Carell, E, Izzo, M, Karim, A, Zakhary, B, Atieh, M, Leichter, S, Meadows, C, Hotchkiss, D, Abu-Fadel, M, Wiseman, A, Bander, J, Shah, M, Ganim, R, Sopko, K, Khan, M, Lloret, R, Weirick, T, Mehta, R, Thadani, U, Bhargava, A, Moya, J, Staniloae, C, Guerra, Y, Chhabra, A, Kosmicki, D, Shaheen, W, Mohammed, A, Bitters, J, Pattanayak, J, Javier, J, Srivastava, S, Phillips, R, Al-Amin, J, Lillestol, M, Simpson, P, Hazan, L, Amin, A, Shah, G, Korpas, D, Platt, B, Dickert, J, Puente, O, Hiotis, L, Doyle, T, Rajan, R, Meholick, A, Gring, C, Hage-Korban, E, Feldman, R, Colfer, H, Butman, S, Hart, T, Huling, R, Eshaghian, S, Quintana, O, Cheung, D, Handel, F, Rodriguez, M, Suh, D, Gordon, P, Pressman, G, Bauer, M, French, W, Barettella, M, Chatrathi, S, Suresh, D, Goldberg, R, Huth, M, Younis, L, Rahman, A, Mascolo, R, Welch, M, Suneja, R, Smith, S, Shurmur, S, Agaiby, J, Jingo, A, Johnston, J, Beth, M, Vlastaris, A, Kemp, S, Taheri, H, Pereira, E, Deyoung, M, Hawa, Z, Smith, R, Galski, T, Garas, S, Reddy, M, Sharma, S, Hargrove, J, Treasure, C, Emerson, R, Haddad, T, Rohr, K, Levinson, L, Gaona, R, Uretsky, B, Maheshwari, H, Lee, D, Kinnaman, S, Singal, R, Geohas, J, Gigliotti, O, Raisinghani, A, Khurana, C, Hella, B, Kelberman, M, Voyce, S, Singh, S, Lo, E, Singh, P, Goodfellow, R, Fischer, S, Lorraine, R, Turner, T, Shanes, J, Busch, R, Broker, R, Zaniewski, M, Pounds, K, Debs-Perez, G, Ong, S, Frandsen, B, Fullington, D, Jaffrani, N, Khan, A, Lee, M, Pouzar, J, Revtyak, G, Gonzalez, J, Nakhle, S, Murillo, A, Young, D, Makam, S, Syed, M, Woolf, K, Grena, P, Alfata, S, Mahal, S, Hoffman, D, Kizhakekuttu, T, Deering, J, Bhavsar, J, Mikesell, S, Wilson, W, Wilson, V, El, S, Spinale, F, Kannarkat, V, Rao, S, Hanson, L, Bertsch, J, Gonzalez-Ortiz, E, Severino, N, Willis, J, Schock, J, Bakhtari, L, Gazmuri, R, Ansari, S, Hall, J, Mehta, A, Shealy, N, Zarich, S, Singh, D, Vora, K, Andrawis, N, Molter, D, Maron, D, Cardona, J, D'Agostino, R, Arshad, T, Samaan, R, Jones, D, Presser, D, Heath, J, Green, S, Bittar, G, Henry, S, Korn, D, Schmedtje, J, Nadar, V, Graham, B, Labroo, A, Clavijo, L, Roseman, H, Ledesma, G, Rosen, R, Dor, I, Kirby, W, Sutton, J, Eder, F, Iteld, B, Gomez-Cortes, J, Buchbinder, M, Kasper, J, Terrelonge, A, Torres, G, Jagielo, T, Alvarez, J, Handelsman, Y, Guillen, M, Richwine, R, Lewy-Alterbaum, L, Corder, C, Arvind, M, Bolshoun, D, Mikhail, M, Minton, S, Alvarado, O, Abbott, J, Cauthen, B, Welter, R, Mintz, R, Cox, J, Quick, A, Weiss, M, Dy, J, Zebrack, J, Gandelman, G, Hegde, V, Silver, M, Degregorio, M, Lawson, W, Paa, C, Bortnick, A, Krolick, M, Sotolongo, R, Cheirif, J, Kumar, P, Jetty, P, Patel, A, Kruk, M, Kobielusz-Gembala, I, Rewerska, B, Madrzejewski, A, Milewski, K, Cygler, J, Petryka-Mazurkiewicz, J, Jastrzebski, W, Korecki, J, Fil, W, Prokopczuk, J, Bochenek, A, Wujkowski, M, Witek, R, Konczakowski, P, Miekus, P, Szczasny, M, Musial, W, Cymerman, K, Lampart, J, Mikosinski, J, Szynal, S, Fares, I, Opolski, G, Mazur, S, Wozakowska-Kaplon, B, Bijata-Bronisz, R, Wierucki, L, Losa, B, Drelich, G, Konieczny, M, Starczewski, P, Pawlowicz, L, Jesionowski, P, Jurowiecki, J, Gniot, J, Czyzycki, M, Stania, K, Kucharczyk-Bauman, I, Busz-Papiez, B, Karczmarczyk, A, Sudnik, W, Koszek, A, Kolodziej, P, Skwarna, B, Jaramillo, N, Jankowski, M, Czochra, W, Kinasz, L, Miklaszewicz, B, Stasinska, T, Pluta, W, Basiak, M, Rusicka, T, Niedbal-Yahfouf, I, Popenda, G, Korzeniak, R, Mirek, A, 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L, Such, S, Fulop, P, Farsky, S, Bugan, V, Strbova, J, Micko, K, Palka Jr, J, Sivak, V, Kristensen, D, Refsgaard, J, Holmvang, L, Dixen, U, Nielsen, H, Egstrup, K, Jensen, L, Sykulski, R, Rasmussen, O, Andries, A, Luckow, A, Nielsen, G, Sorensen, T, Wongvipaporn, C, Chamnarnphol, N, Srimahachota, S, Sansanayudh, N, Kuanprasert, S, Tresukosol, D, Sookananchai, B, Kanadasi, M, Ozcan, T, Kucuk, M, Ongen, Z, Okuyan, E, Arat, A, Acikel, S, Yalcin, A, Guray, U, Ceyhan, C, Ozer, N, Arslan, S, Angeras, O, Johnston, N, Weiderman, A, Bandh, S, Hansen, O, Larnefeldt, H, Kusiak, D, Lindholm, C, Hedman, A, Erlinge, D, Curiac, D, Lundman, P, Zucconi-Mazzini, R, Aladellie, L, Jensen, J, Verwerft, J, Vrolix, M, Faes, D, Striekwold, H, Sinnaeve, P, Timmermans, P, Guedes, A, Delforge, M, Nimmegeers, J, Stammen, F, Buysschaert, I, Hoffer, E, Hollanders, G, Vervoort, G, Coussement, P, de Maeseneire, S, Janssens, L, Gravdal, S, Risberg, K, Gullestad, L, Hofseth, O, Nilsen, D, Lappegard, K, van den Heuvel, 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Mannucci, E, Mauro, C, Ragonese, M, Fresco, C, Turturo, M, Marcucci, R, Lievano Triana, M, Arana, C, Accini, J, Botero, R, Muzyk-Osikowicz, M, Dada, F, Vallejo, G, Manzur, F, Isaza, D, Molina, D, Mesa, J, Quintero, A, Nyman, K, Makela, J, Strand, J, Nieminen, S, Taurio, J, Kuusela, M, Valle, T, Pietila, M, Kekki, S, Strandberg, T, Klutstein, M, Greenberg, G, Rozenman, Y, Chorin, E, Roguin, A, Lewis, B, Bashkin, A, Tan, E, Prado, J, Ferrolino, A, Babilonia, N, Barbas, B, Matiga, G, Coching, R, Drexel, H, Brath, H, Schnack, C, Hanusch, U, Fliesser-Gorzer, E, Paulweber, B, Ebenbichler, C, Prager, R, Huber, K, Wolzt, M, Auer, J, Berger, R, Schernthaner, G, Stanciulescu, G, Creteanu, M, Spiridon, M, Dobreanu, V, Vinereanu, D, Iosipescu, L, Istratoaie, O, Coman, I, Militaru, C, Cinteza, M, Nicolau, J, Kerr Saraiva, J, Widimsky, P, Kristensen, S, Hartikainen, J, Darius, H, Tse, H, Pais, P, Lev, E, de Luca, L, Ramos Lopez, G, Kontny, F, Zateyshchikov, D, Ruda, M, Elamin, O, Kovar, F, Bueno, H, Leonsson-Zachrisson, M, Université Paris Diderot - Paris 7 (UPD7)-Université Paris 13 (UP13)-Institut National de la Santé et de la Recherche Médicale (INSERM), Service de pharmacologie - Dosage de médicaments [CHU Saint-Antoine], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-CHU Saint-Antoine [AP-HP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU)-Sorbonne Université (SU), and Royal Brompton and Harefield NHS Foundation Trust-Imperial College London
Subjects: Male, Platelet Aggregation Inhibitors/therapeutic use, THEMIS Steering Committee and Investigators, medicine.medical_treatment, Vascular damage Radboud Institute for Health Sciences [Radboudumc 16], 030204 cardiovascular system & hematology, Coronary Angiography, Stroke/epidemiology, Coronary artery disease, DOUBLE-BLIND, 0302 clinical medicine, Hemorrhage/chemically induced, acetylsalicylic acid, antidiabetic agent, placebo, ticagrelor, Secondary Prevention, Medicine, 030212 general & internal medicine, Myocardial infarction, Coronary Artery Bypass, Cardiovascular Diseases/mortality, 11 Medical and Health Sciences, OUTCOMES, Aspirin, [SDV.MHEP] Life Sciences [q-bio]/Human health and pathology, General Medicine, Middle Aged, Clopidogrel, 3. Good health, Ticagrelor/therapeutic use, DRUG-ELUTING STENTS, CLOPIDOGREL, Cardiology, PLATELET INHIBITION, Drug Therapy, Combination, Female, Life Sciences & Biomedicine, Ticagrelor, TIMI, medicine.drug, Coronary Artery Disease/complications, medicine.medical_specialty, Hypoglycemic Agents/therapeutic use, POOLED ANALYSIS, 03 medical and health sciences, Medicine, General & Internal, Percutaneous Coronary Intervention, Double-Blind Method, General & Internal Medicine, Internal medicine, Myocardial Infarction/epidemiology, Humans, Aged, Science & Technology, ANTIPLATELET THERAPY, business.industry, Diabetes Mellitus, Type 2/complications, ELEVATION MYOCARDIAL-INFARCTION, RIVAROXABAN, Percutaneous coronary intervention, medicine.disease, ASPIRIN, Coronary Stenosis/diagnostic imaging, Aspirin/therapeutic use, Conventional PCI, business, [SDV.MHEP]Life Sciences [q-bio]/Human health and pathology
Abstract: Contains fulltext : 215333.pdf (Publisher’s version ) (Closed access) BACKGROUND: Patients with stable coronary artery disease and diabetes with previous percutaneous coronary intervention (PCI), particularly those with previous stenting, are at high risk of ischaemic events. These patients are generally treated with aspirin. In this trial, we aimed to investigate if these patients would benefit from treatment with aspirin plus ticagrelor. METHODS: The Effect of Ticagrelor on Health Outcomes in diabEtes Mellitus patients Intervention Study (THEMIS) was a phase 3 randomised, double-blinded, placebo-controlled trial, done in 1315 sites in 42 countries. Patients were eligible if 50 years or older, with type 2 diabetes, receiving anti-hyperglycaemic drugs for at least 6 months, with stable coronary artery disease, and one of three other mutually non-exclusive criteria: a history of previous PCI or of coronary artery bypass grafting, or documentation of angiographic stenosis of 50% or more in at least one coronary artery. Eligible patients were randomly assigned (1:1) to either ticagrelor or placebo, by use of an interactive voice-response or web-response system. The THEMIS-PCI trial comprised a prespecified subgroup of patients with previous PCI. The primary efficacy outcome was a composite of cardiovascular death, myocardial infarction, or stroke (measured in the intention-to-treat population). FINDINGS: Between Feb 17, 2014, and May 24, 2016, 11 154 patients (58% of the overall THEMIS trial) with a history of previous PCI were enrolled in the THEMIS-PCI trial. Median follow-up was 3.3 years (IQR 2.8-3.8). In the previous PCI group, fewer patients receiving ticagrelor had a primary efficacy outcome event than in the placebo group (404 [7.3%] of 5558 vs 480 [8.6%] of 5596; HR 0.85 [95% CI 0.74-0.97], p=0.013). The same effect was not observed in patients without PCI (p=0.76, pinteraction=0.16). The proportion of patients with cardiovascular death was similar in both treatment groups (174 [3.1%] with ticagrelor vs 183 (3.3%) with placebo; HR 0.96 [95% CI 0.78-1.18], p=0.68), as well as all-cause death (282 [5.1%] vs 323 [5.8%]; 0.88 [0.75-1.03], p=0.11). TIMI major bleeding occurred in 111 (2.0%) of 5536 patients receiving ticagrelor and 62 (1.1%) of 5564 patients receiving placebo (HR 2.03 [95% CI 1.48-2.76], p
Published: 2019
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77. Effects of alirocumab on cardiovascular and metabolic outcomes after acute coronary syndrome in patients with or without diabetes: a prespecified analysis of the ODYSSEY OUTCOMES randomised controlled trial

Author: Kausik K Ray, Helen M Colhoun, Michael Szarek, Marie Baccara-Dinet, Deepak L Bhatt, Vera A Bittner, Andrzej J Budaj, Rafael Diaz, Shaun G Goodman, Corinne Hanotin, Robert A Harrington, J Wouter Jukema, Virginie Loizeau, Renato D Lopes, Angèle Moryusef, Jan Murin, Robert Pordy, Arsen D Ristic, Matthew T Roe, José Tuñón, Harvey D White, Andreas M Zeiher, Gregory G Schwartz, Philippe Gabriel Steg, Gregory G. Schwartz, Ph. Gabriel Steg, Deepak L. Bhatt, Vera A. Bittner, Shaun G. Goodman, Robert A. Harrington, J. Wouter Jukema, Harvey D. White, Andreas M. Zeiher, Pierluigi Tricoci, Matthew T. Roe, Kenneth W. Mahaffey, Jay M. Edelberg, Guillaume Lecorps, William J. Sasiela, Jean-François Tamby, Philip E. Aylward, Heinz Drexel, Peter Sinnaeve, Mirza Dilic, Renato D. Lopes, Nina N. Gotcheva, Juan-Carlos Prieto, Huo Yong, Patricio López-Jaramillo, Ivan Pećin, Zeljko Reiner, Petr Ostadal, Margus Viigimaa, Markku S. Nieminen, Vakhtang Chumburidze, Nikolaus Marx, Nicolas Danchin, Evangelos Liberopoulos, Pablo Carlos Montenegro Valdovinos, Hung-Fat Tse, Robert Gabor Kiss, Denis Xavier, Doron Zahger, Marco Valgimigli, Takeshi Kimura, Hyo Soo Kim, Sang-Hyun Kim, Andrejs Erglis, Aleksandras Laucevicius, Sasko Kedev, Khalid Yusoff, Gabriel Arturo Ramos López, Marco Alings, Sigrun Halvorsen, Roger M. Correa Flores, Andrzej Budaj, Joao Morais, Maria Dorobantu, Yuri Karpov, Arsen D. Ristic, Terrance Chua, Zlatko Fras, Anthony J. Dalby, H. Asita de Silva, Emil Hagström, Ulf Landmesser, Chern-En Chiang, Piyamitr Sritara, Sema Guneri, Alexander Parkhomenko, Kausik K. Ray, Patrick M. Moriarty, Robert Vogel, Bernard Chaitman, Sheryl F. Kelsey, Anders G. Olsson, Jean-Lucien Rouleau, Maarten L. Simoons, Karen Alexander, Chiara Meloni, Robert Rosenson, Eric J.G. Sijbrands, John H. Alexander, Luciana Armaganijan, Akshay Bagai, Maria Cecilia Bahit, J. Matthew Brennan, Shaun Clifton, Adam D. DeVore, Shalonda Deloatch, Sheila Dickey, Keith Dombrowski, Grégory Ducrocq, Zubin Eapen, Patricia Endsley, Arleen Eppinger, Robert W. Harrison, Connie Ng Hess, Mark A. Hlatky, Joseph Dedrick Jordan, Joshua W. Knowles, Bradley J. Kolls, David F. Kong, Sergio Leonardi, Linda Lillis, David J. Maron, Jill Marcus, Robin Mathews, Rajendra H. Mehta, Robert J. Mentz, Humberto Graner Moreira, Chetan B. Patel, Sabrina Bernardez-Pereira, Lynn Perkins, Thomas J. Povsic, Etienne Puymirat, William Schuyler Jones, Bimal R. Shah, Matthew W. Sherwood, Kenya Stringfellow, Darin Sujjavanich, Mustafa Toma, Charlene Trotter, Sean Van Diepen, Matthew D. Wilson, Andrew T. Yan, Lilia B. Schiavi, Marcelo Garrido, Andrés F. Alvarisqueta, Sonia A. Sassone, Anselmo P. Bordonava, Alberto E. Alves De Lima, Jorge M. Schmidberg, Ernesto A. Duronto, Orlando C. Caruso, Leonardo P. Novaretto, Miguel Angel Hominal, Oscar R. Montaña, Alberto Caccavo, Oscar A. Gomez Vilamajo, Alberto J. Lorenzatti, Luis R. Cartasegna, Gustavo A. Paterlini, Ignacio J. Mackinnon, Guillermo D. Caime, Marcos Amuchastegui, Oscar Salomone, Oscar R. Codutti, Horacio O. Jure, Julio OE Bono, Adrian D. Hrabar, Julio A. Vallejos, Rodolfo A. Ahuad Guerrero, Federico Novoa, Cristian A. Patocchi, Cesar J. Zaidman, Maria E. Giuliano, Ricardo D. Dran, Marisa L. Vico, Gabriela S. Carnero, Pablo N. Guzman, Juan C. Medrano Allende, Daniela F. 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Negron Miguel, S, Sanabria Perez, E, Carrion Chambilla, J, Chavez Ayala, C, Castillo Leon, R, Vargas Gonzales, R, Hernandez Zuniga, J, Camacho Cosavalente, L, Bravo Mannucci, J, Heredia Landeo, J, Llerena Navarro, N, Roldan Concha, Y, Rodriguez Chavez, V, Anchante Hernandez, H, Zea Nunez, C, Mogrovejo Ramos, W, Ferrolino, A, Sy, R, Tirador, L, Matiga, G, Coching, R, Bernan, A, Rogelio, G, Morales, D, Tan, E, Sulit, D, Wlodarczak, A, Jaworska, K, Skonieczny, G, Pawlowicz, L, Wojewoda, P, Busz-Papiez, B, Bednarski, J, Goch, A, Staneta, P, Dulak, E, Saminski, K, Krasowski, W, Sudnik, W, Zurakowski, A, Skorski, M, Miklaszewicz, B, Kubica, J, Andrzej Lipko, J, Kostarska-Srokosz, E, Piepiorka, M, Drzewiecka, A, Stasiewski, A, Blicharski, T, Bystryk, L, Szpajer, M, Korol, M, Czerski, T, Mirek-Bryniarska, E, Gniot, J, Lubinski, A, Gorny, J, Franek, E, Raczak, G, Szwed, H, Monteiro, P, Mesquita Bastos, J, Pereira, H, Martins, D, Seixo, F, Mendonca, C, Botelho, A, Caetano, F, Minescu, B, Istratoaie, O, Tesloianu, D, Cristian, G, Dumitrescu, S, Podoleanu, C, Constantinescu, M, Bengus, C, Militaru, C, Rosu, D, Parepa, I, Matei, A, Alexandru, T, Malis, M, Coman, I, Stanescu-Cioranu, R, Dimulescu, D, Shvarts, Y, Orlikova, O, Kobalava, Z, Barbarash, O, Markov, V, Lyamina, N, Gordienko, A, Zrazhevsky, K, Vishnevsky, A, Gurevich, V, Stryuk, R, Lomakin, N, Bokarev, I, Khlevchuk, T, Shalaev, S, Khaisheva, L, Chizhov, P, Viktorova, I, Osokina, N, Shchekotov, V, Akatova, E, Chumakova, G, Libov, I, Voevoda, M, Tretyakova, T, Baranov, E, Shustov, S, Yakushin, S, Gordeev, I, Khasanov, N, Reshetko, O, Sotnikova, T, Molchanova, O, Nikolaev, K, Gapon, L, Baranova, E, Shogenov, Z, Kosmachova, E, Povzun, A, Egorova, L, Tyrenko, V, Ivanov, I, Ilya, M, Kanorsky, S, Simic, D, Ivanovic, N, Davidovic, G, Tasic, N, Asanin, M, Stojic, S, Apostolovic, S, Ilic, S, Putnikovic Tosic, B, Stankovic, A, Arandjelovic, A, Radovanovic, S, Todic, B, Balinovac, J, Dincic, D, Seferovic, P, Karadzic, A, Dodic, S, Dimkovic, S, Jakimov, T, Poh, K, Ong, H, Tang I-Shing, J, Micko, K, Nociar, J, Pella, D, Fulop, P, Hranai, M, Palka, J, Mazur, J, Majercak, I, Dzupina, A, Fazekas, F, Gonsorcik, J, Bugan, V, Selecky, J, Kamensky, G, Strbova, J, Smik, R, Dukat, A, Zuran, I, Poklukar, J, Cernic Suligoj, N, Cevc, M, Cyster, H, Ranjith, N, Corbett, C, Bayat, J, Makotoko, E, du Toit Theron, H, Kapp, I, de V Basson, M, Lottering, H, Van Aswegen, D, Van Zyl, L, Sebastian, P, Pillay, T, Saaiman, J, Commerford, P, Cassimjee, S, Riaz, G, Ebrahim, I, Sarvan, M, Mynhardt, J, Reuter, H, Moodley, R, Vida, M, Cequier Fillat, A, Bodi Peris, V, Fuentes Jimenez, F, Marin, F, Cruz Fernandez, J, Hidalgo Urbano, R, Gil-Extremera, B, Toledo, P, Worner Diz, F, Garcia-Dorado, D, Iniguez, A, Gonzalez-Juanatey, J, Fernandez Portales, J, Civeira Murillo, F, Matas Pericas, L, Zamorano, J, De Mora Martin, M, Bruguera Cortada, J, Alonso Martin, J, Serrano Antolin, J, De Berrazueta Fernandez, J, Vazquez de Prada, J, Diaz Fernandez, J, Garcia Lledo, J, Cosin Sales, J, Botas Rodriguez, J, Gusi Tragant, G, Benedicto, A, Gonzalez-Juanatey, C, Camprubi Potau, M, Plaza Perez, I, De La Tassa, C, Loma-Osorio Rincon, P, Balaguer Recena, J, Escudier, J, Payeras, A, Alonso Orcajo, N, Valdivielso, P, Constantine, G, Haniffa, R, Tissera, N, Amarasekera, S, Ponnamperuma, C, Fernando, N, Fernando, K, Jayawardena, J, Wijeyasingam, S, Ranasinghe, G, Ekanayaka, R, Mendis, S, Senaratne, V, Mayurathan, G, Sirisena, T, Rajapaksha, A, Herath, J, Amarasena, N, Berglund, S, Rasmanis, G, Vedin, O, Witt, N, Mourtzinis, G, Nicol, P, Hansen, O, Romeo, S, Agergaard Jensen, S, Torstensson, I, Ahremark, U, Sundelin, T, Moccetti, T, Muller, C, Mach, F, Binde, R, Tsai, W, Ueng, K, Lai, W, Liu, M, Hwang, J, Yin, W, Hsieh, I, Hsieh, M, Kuo, J, Huang, T, Fang, C, Kaewsuwanna, P, Soonfuang, W, Jintapakorn, W, Sukonthasarn, A, Wongpraparut, N, Sastravaha, K, Sansanayudh, N, Kehasukcharoen, W, Piyayotai, D, Chotnoparatpat, P, Camsari, A, Kultursay, H, Mutlu, B, Ersanli, M, Demirtas, M, Kirma, C, Ural, E, Koldas, L, Karpenko, O, Prokhorov, A, Vakaluyk, I, Myshanych, H, Reshotko, D, Batushkin, V, Rudenko, L, Kovalskyi, I, Kushnir, M, Tseluyko, V, Mostovoy, Y, Stanislavchuk, M, Kyiak, Y, Karpenko, Y, Malynovsky, Y, Klantsa, A, Kutniy, O, Amosova, E, Tashchuk, V, Leshchuk, O, Rishko, M, Kopytsya, M, Yagensky, A, Vatutin, M, Bagriy, A, Barna, O, Ushakov, O, Dzyak, G, Goloborodko, B, Rudenko, A, Zheleznyy, V, Trevelyan, J, Zaman, A, Lee, K, Moriarty, A, Aggarwal, R, Clifford, P, Wong, Y, Iqbal, S, Subkovas, E, Braganza, D, Sarkar, D, Storey, R, Griffiths, H, Mcclure, S, Muthusamy, R, Smith, S, Kurian, J, Levy, T, Barr, C, Kadr, H, Gerber, R, Simaitis, A, Soran, H, Mathur, A, Brodison, A, Ayaz, M, Cheema, M, Oliver, R, Thackray, S, Mudawi, T, Rahman, G, Sultan, A, Sharman, D, Sprigings, D, Butler, R, Wilkinson, P, Lip, G, Halcox, J, Gallagher, S, Ossei-Gerning, N, Vardi, G, Baldari, D, Brabham, D, Treasure II, C, Dahl, C, Palmer, B, Wiseman, A, Puri, S, Mohart, A, Ince, C, Flores, E, Wright, S, Cheng, S, Rosenberg, M, Rogers, W, Kosinski, E, Forgosh, L, Waltman, J, Khan, M, Shoukfeh, M, Dagher, G, Cambier, P, Lieber, I, Kumar, P, East, C, Krichmar, P, Hasan, M, White, L, Knickelbine, T, Haldis, T, Gillespie, E, Amidon, T, Suh, D, Arif, I, Abdallah, M, Akhter, F, Carlson, E, D'Urso, M, El-Ahdab, F, Nelson, W, Moriarty, K, Harris, B, Cohen, S, Carter, L, Doty, D, Sabatino, K, Haddad, T, Malik, A, Rao, S, Mulkay, A, Jovin, I, Klancke, K, Malhotra, V, Devarapalli, S, Koren, M, Chandna, H, Dodds III, G, Goraya, T, Bengston, J, Janik, M, Moran, J, Sumner, A, Kobayashi, J, Davis, W, Yazdani, S, Pasquini, J, Thakkar, M, Vedere, A, Leimbach, W, Rider, J, Fenton, S, Singh, N, Shah, A, Janosik, D, Pepine, C, Berman, B, Gelormini, J, Daniels, C, Richard, K, Keating, F, Kondo, N, Shetty, S, Levite, H, Waider, W, Takata, T, Abu-Fadel, M, Shah, V, Izzo, M, Kumar, A, Hattler, B, Do, R, Link, C, Bortnick, A, Kinzfogl III, G, Ghitis, A, Larry, J, Teufel, E, Kuhlman, P, Mclaurin, B, Zhang, W, Thew, S, Abbas, J, White, M, Islam, O, Subherwal, S, Ranadive, N, Vakili, B, Gring, C, Henderson, D, Schuchard, T, Farhat, N, Kline, G, Mahal, S, Whitaker, J, Speirs, S, Andersen, R, Daboul, N, Horwitz, P, Zahr, F, Ponce, G, Jafar, Z, Mcgarvey, J, Panchal, V, Voyce, S, Blok, T, Sheldon, W, Azizad, M, Schmalfuss, C, Picone, M, Pederson, R, Herzog, W, Friedman, K, Lindsey, J, Nowins, R, Timothy, E, Leonard, P, Lepor, N, El Shahawy, M, Weintraub, H, Irimpen, A, Alonso, A, May, W, Christopher, D, Galski, T, Chu, A, Mody, F, Ramin, E, Hodes, Z, Rossi, J, Rose, G, Fairlamb, J, Lambert, C, Raisinghani, A, Abbate, A, Vetrovec, G, King, M, Carey, C, Gerber, J, Younis, L, Vidovich, M, Knutson, T, Friedman, D, Chaleff, F, Loussararian, A, Rozeman, P, Kimmelstiel, C, Kuvin, J, Silver, K, Foster, M, Tonnessen, G, Espinoza, A, Amlani, M, Wali, A, Malozzi, C, Jong, G, Massey, C, Wattanakit, K, O'Donnell, P, Singal, D, Jaffrani, N, Banuru, S, Fisher, D, Xenakis, M, Perlmutter, N, Bhagwat, R, Strader, J, Blonder, R, Akyea-Djamson, A, Labroo, A, Marais, H, Claxton, E, Weiss, R, Kathryn, R, Berk, M, Joshi, P, Khera, A, Khaira, A, Kumkumian, G, Lupovitch, S, Purow, J, Welka, S, Hoffman, D, Fischer, S, Soroka, E, Eagerton, D, Pancholy, S, Ray, M, Erenrich, N, Farrar, M, Pollock, S, French, W, Diamantis, S, Guy, D, Gimple, L, Neustel, M, Schwartz, S, Pereira, E, Albert, S, Spriggs, D, Strain, J, Mittal, S, Vo, A, Chane, M, Hall, J, Vijay, N, Lotun, K, Lester, F, Nahhas, A, Pope, T, Nager, P, Vohra, R, Sharma, M, Bashir, R, Ahmed, H, Berlowitz, M, Fishberg, R, Barrucco, R, Yang, E, Radin, M, Sporn, D, Stapleton, D, Eisenberg, S, Landzberg, J, Mcgough, M, Turk, S, Schwartz, M, Sundram, P, Jain, D, Zainea, M, Bayron, C, Karlsberg, R, Dohad, S, Lui, H, Keen, W, Westerhausen, D, Khurana, S, Agarwal, H, Birchem, J, Penny, W, Chang, M, Murphy, S, Henry, J, Schifferdecker, B, Gilbert, J, Chalavarya, G, Eaton, C, Schmedtje, J, Christenson, S, Dotani, I, Denham, D, Macdonell, A, Gibson, P, Rahman, A, Al Joundi, T, Assi, N, Conrad, G, Kotha, P, Love, M, Giesler, G, Rubenstein, H, Gamil, D, Akright, L, Krawczyk, J, Cobler, J, Wells, T, Welker, J, Foster, R, Gilmore, R, Anderson, J, Jacoby, D, Gardner, G, Dandillaya, R, Vora, K, Kostis, J, Hunter, J, Laxson, D, Ball, E, Egydio, F, Kawakami, A, Oliveira, J, Wozniak, J, Matthews, A, Ratky, C, Valiris, J, Berdan, L, Hepditch, A, Quintero, K, Rorick, T, Westbrook, M, Pascual, A, Rovito, C, Bezault, M, Drouet, E, Simon, T, Alsweiler, C, Luyten, A, Butters, J, Griffith, L, Shaw, M, Grunberg, L, Islam, S, Bregeault, M, Bougon, N, Faustino, D, Fontecave, S, Murphy, J, Verrier, M, Agnetti, V, Andersen, D, Badreddine, E, Bekkouche, M, Bouancheau, C, Brigui, I, Brocklehurst, M, Cianciarulo, J, Devaul, D, Domokos, S, Gache, C, Gobillot, C, Guillou, S, Healy, J, Heath, M, Jaiwal, G, Javierre, C, Labeirie, J, Monier, M, Morales, U, Mrabti, A, Mthombeni, B, Okan, B, Smith, L, Sheller, J, Sopena, S, Pellan, V, Benbernou, F, Bengrait, N, Lamoureux, M, Kralova, K, Scemama, M, Bejuit, R, Coulange, A, Berthou, C, Repincay, J, Lorenzato, C, Etienne, A, Gouet, V, Normand, M, Ourliac, A, Rondel, C, Adamo, A, Beltran, P, Barraud, P, Dubois-Gache, H, Halle, B, Metwally, L, Mourgues, M, Sotty, M, Vincendet, M, Cotruta, R, Chengyue, Z, Fournie-Lloret, D, Morrello, C, Perthuis, A, Picault, P, Zobouyan, I, Dempsey, M, Mcclanahan, M, ODYSSEY OUTCOMES Comm Investigato, and Ege Üniversitesi
Subjects: Male, BIOMEDICINE AND HEALTHCARE. Clinical Medical Sciences, STATIN THERAPY, blood-glucose, Endocrinology, Diabetes and Metabolism, GUIDELINES, PCSK9, 0302 clinical medicine, Endocrinology, GENETIC-VARIANTS, Cardiovascular Disease, Diabetes Complication, Aged Antibodies, Monoclonal, Humanized / therapeutic use* Cardiovascular Diseases / blood Cardiovascular Diseases / prevention & control* Diabetes Complications / blood Diabetes Complications / prevention & control* Female Humans Male Middle Aged Substances, Clinical endpoint, Medicine, guidelines, 030212 general & internal medicine, Prediabetes, Myocardial infarction, myocardial-infarction, genetic-variants, statin therapy, risk, pcsk9, association, liraglutide, evolocumab, RISK, BIOMEDICINA I ZDRAVSTVO. Kliničke medicinske znanosti, BLOOD-GLUCOSE, ASSOCIATION, Middle Aged, Cardiovascular Diseases, Female, Life Sciences & Biomedicine, Human, medicine.medical_specialty, Acute coronary syndrome, PCSK9 inhibitor, acute coronary syndrome, lipoprotein(a), low-density lipoprotein cholesterol, 030209 endocrinology & metabolism, Antibodies, Monoclonal, Humanized, Diabetes Complications, Endocrinology & Metabolism, 03 medical and health sciences, Diabetes mellitus, Internal medicine, Internal Medicine, Humans, Aged, Alirocumab, diabetes, PCSK9, hyperlipidemia, Science & Technology, ODYSSEY OUTCOMES Committees and Investigators, business.industry, Unstable angina, EVOLOCUMAB, medicine.disease, MYOCARDIAL-INFARCTION, LIRAGLUTIDE, Human medicine, business
Abstract: Doi, Yasuji/0000-0002-8368-0827; galvani, marcello/0000-0001-5897-667X; Gislason, Gunnar H/0000-0002-0548-402X; Taskinen, Marja-Riitta/0000-0002-6229-3588; Sherwood, Matthew/0000-0002-4305-5883; Malynovsky, Yaroslav V/0000-0002-9118-1104; Viktorova, vic-inna@mail.ru I.A./0000-0001-8728-2722; bastos, jose/0000-0002-9526-3123; Yang, Eric H/0000-0003-4889-7454; Rudenko, Anatoliy Viktorovich/0000-0003-1099-1613; Novotny, Vojtech/0000-0003-3521-9945; Nikolaev, Konstantin/0000-0003-4601-6203; Reshetko, Olga/0000-0003-3107-7636; Leonardi, Sergio/0000-0002-4800-6132; Muenzel, Thomas/0000-0001-5503-4150; Ushakov, Alexei V/0000-0002-7020-4442; Tse, Hung Fat/0000-0002-9578-7808; Podoleanu, Cristian/0000-0001-9987-2519; Raffel, Owen C/0000-0001-5470-7050; Khasanov, Niiaz/0000-0002-7760-0763; Chumakova, Galina A/0000-0002-2810-6531; Ersanli, Murat/0000-0003-1847-3087; cornel, jan hein/0000-0002-1006-2112; Abbate, Antonio/0000-0002-1930-785X; Racca, Vittorio/0000-0002-4465-3789; Urina-Triana, Miguel A/0000-0001-6003-4622; Rasputina, Lesia/0000-0003-1230-4039; Racca, Vittorio/0000-0002-4465-3789; Reis, Gilmar/0000-0002-4847-1034; Sandhu, Manjinder/0000-0003-2538-2079; Keskin, Kudret/0000-0002-9049-1530; PAREPA, IRINEL/0000-0002-7571-9015; Manakshe, Gajendra/0000-0002-4983-4271; Nicolau, Jose C/0000-0002-9680-3689; Strelnieks, Aldis/0000-0003-3493-2562; Budaj, Andrzej/0000-0002-6395-2098; Marin, Francisco/0000-0001-7246-7708; Wongpraparut, Nattawut/0000-0002-1541-3313; Yuan, Zuyi/0000-0002-4141-0298; Jeong, Myung Ho/0000-0003-2424-810X; Mostovoy, Yuriy/0000-0002-7041-1230; Pepine, Carl/0000-0002-6011-681X; Lopez-Jaramillo, Patricio/0000-0002-9122-8742; Garcia-Lledo, Alberto/0000-0002-8986-2584; Tesloianu, Nicolae-Dan/0000-0002-1007-3022; Kosmacheva, Elena/0000-0001-8600-0199; Kunz Sebba Barroso Souza, Weimar/0000-0002-1265-1930; Katz, Amos/0000-0003-0422-934X; Tunon, Jose/0000-0002-1373-0999; Acevedo, Monica/0000-0002-7989-6633; Hove, Jens/0000-0002-5600-5623; Yakushin, Sergey/0000-0001-7202-742X; Gonzalez Juanatey, Jose Ramon/0000-0001-9681-3388; Lyamina, Nadezhda/0000-0001-6939-3234; Aylward, Philip/0000-0002-5358-8552; Apostolovic, Svetlana/0000-0001-9015-297X; Airaksinen, Juhani/0000-0002-0193-568X; Nahhas, Prof. Dr. Ahmed/0000-0002-2887-8187; Barbarash, Olga/0000-0002-4642-3610, WOS: 000475553300016, PubMed: 31272931, Background After acute coronary syndrome, diabetes conveys an excess risk of ischaemic cardiovascular events. A reduction in mean LDL cholesterol to 1.4-1.8 mmol/L with ezetimibe or statins reduces cardiovascular events in patients with an acute coronary syndrome and diabetes. However, the efficacy and safety of further reduction in LDL cholesterol with an inhibitor of proprotein convertase subtilisin/kexin type 9 (PCSK9) after acute coronary syndrome is unknown. We aimed to explore this issue in a prespecified analysis of the ODYSSEY OUTCOMES trial of the PCSK9 inhibitor alirocumab, assessing its effects on cardiovascular outcomes by baseline glycaemic status, while also assessing its effects on glycaemic measures including risk of new-onset diabetes. Methods ODYSSEY OUTCOMES was a randomised, double-blind, placebo-controlled trial, done at 1315 sites in 57 countries, that compared alirocumab with placebo in patients who had been admitted to hospital with an acute coronary syndrome (myocardial infarction or unstable angina) 1-12 months before randomisation and who had raised concentrations of atherogenic lipoproteins despite use of high-intensity statins. Patients were randomly assigned (1: 1) to receive alirocumab or placebo every 2 weeks; randomisation was stratified by country and was done centrally with an interactive voice-response or web-response system. Alirocumab was titrated to target LDL cholesterol concentrations of 0.65-1.30 mmol/L. in this prespecified analysis, we investigated the effect of alirocumab on cardiovascular events by glycaemic status at baseline (diabetes, prediabetes, or normoglycaemia)-defined on the basis of patient history, review of medical records, or baseline HbA(1c) or fasting serum glucose-and risk of new-onset diabetes among those without diabetes at baseline. the primary endpoint was a composite of death from coronary heart disease, non-fatal myocardial infarction, fatal or non-fatal ischaemic stroke, or unstable angina requiring hospital admission. ODYSSEY OUTCOMES is registered with ClinicalTrials. gov, number NCT01663402. Findings At study baseline, 5444 patients (28.8%) had diabetes, 8246 (43.6%) had prediabetes, and 5234 (27.7%) had normoglycaemia. There were no significant differences across glycaemic categories in median LDL cholesterol at baseline (2.20-2.28 mmol/L), after 4 months' treatment with alirocumab (0.80 mmol/L), or after 4 months' treatment with placebo (2.25-2.28 mmol/L). in the placebo group, the incidence of the primary endpoint over a median of 2.8 years was greater in patients with diabetes (16.4%) than in those with prediabetes (9.2%) or normoglycaemia (8.5%); hazard ratio (HR) for diabetes versus normoglycaemia 2.09 (95% CI 1.78-2.46, p, Sanofi; Regeneron Pharmaceuticals, Sanofi and Regeneron Pharmaceuticals.
Published: 2019
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78. Comparison of dose modification strategies to address expected hematologic toxicities in treatment-naïve higher-risk (HR) MDS patients treated with venetoclax + azacitidine

Author: Chun Yew Fong, Uwe Platzbecker, Jacqueline S. Garcia, Daniel Nowak, Meagan A. Jacoby, Andrew H. Wei, Steve Kye, Guillermo Garcia-Manero, Maria R. Baer, Olatoyosi Odenike, Kiran Naqvi, David Hoffman, Ying Zhou, Pierre Peterlin, Joseph G. Jurcic, Uma Borate, and Ilona Cunningham
Subjects: Oncology, Cancer Research, medicine.medical_specialty, business.industry, Venetoclax, Azacitidine, Complete remission, Therapy naive, chemistry.chemical_compound, chemistry, Internal medicine, Ven, medicine, business, Dose Modification, medicine.drug
Abstract: 7041 Background: Venetoclax (Ven) is a selective, potent BCL-2 inhibitor. Ven + azacitidine (Aza) were associated with a combined complete remission (CR)/marrow CR (mCR) rate of 79% in a phase 1b study of patients (pts) with HR-MDS. Here we compared two different dose modification strategies to manage expected hematologic toxicities in two safety expansion cohorts with similar follow-up periods. Methods: Pts ≥18y diagnosed with treatment-naïve IPSS intermediate-2 or high-risk MDS with ECOG ≤2 were enrolled. Aza 75 mg/m2 (iv or subQ daily) was administered for 7 days (d) and Ven was administered at 400 mg for 14d in each 28d cycle. In both cohorts, dose modification during Cycle 1 was not recommended; dose modifications in subsequent cycles were prescribed for AEs. In Safety Expansion Cohort 1 (SE1), either Aza or Ven were initially reduced according to investigator’s choice for significant neutrophil or platelet toxicity. Dose reductions per protocol were 33% for Aza and 50% for Ven (for 14d each cycle). In subsequent cycles, Ven duration could be shortened to 9d of each cycle. In Safety Expansion Cohort 2 (SE2), dose modification guidelines recommended stepwise reductions, first in Aza dose (first to 50 mg/m2, then 36 mg/m2) and subsequently in Ven duration to 7d of each cycle (Ven 400 mg). The impact of each dose modification strategy on safety and efficacy in SE1 vs SE2 was compared. Worsening of treatment-emergent adverse events (TEAE) grades from baseline (BL) was analyzed by cycle. Responses were evaluated using IWG 2006 criteria. Analyses included all pts who received ≥1 dose of study drug. Results: We compared 22 pts in SE1 and 21 pts in SE2 with median (range) follow-up of 7.5 (1.0–8.9) and 7.9 (1.8–10.1) mos, respectively. A similar frequency of ≥ G3 hematologic TEAEs (approx %) were reported in SE1 and SE2, respectively, including anemia (14% and 33%), febrile neutropenia (46% and 48%), leukopenia (36% and 19%), neutropenia (55% and 48%) and thrombocytopenia (32% and 38%). Infections (59% and 38%) were more frequent in SE1 than SE2. In a longitudinal analysis, there were more TEAE grade increases from BL to Cycle 1 in SE2 vs SE1. This could be accounted by pts in SE1 and SE2 having unbalanced susceptibility to AEs at BL, as SE1 and SE2 pts received identical Aza + Ven doses in Cycle 1. Response rates were identical: 86% of pts in both SE1 and SE2 had CR or mCR. For pts with mCR, hematologic improvement occurred in 50% of SE1 and 46% of SE2 pts. Conclusions: No obvious hematologic differences were observed when reducing Aza before Ven (SE2) in MDS compared to investigator’s choice (SE1). Both approaches had a similar acceptable safety profile without compromising efficacy for pts with HR-MDS. Clinical trial information: NCT02942290. [Table: see text]
Published: 2021
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79. PEACE SOWERS AROUND THE WORLD : MULTIPLE PERSPECTIVES ON MEDIATION AND RELATED PRACTICES

Author: AKIRA NINOMIYA JR, ARUN GANDHI, DAVID HOFFMAN, AKIRA NINOMIYA JR, ARUN GANDHI, and DAVID HOFFMAN
Abstract: The Peace Sowers Book brings a collection of articles and interviews with experts from different countries, protagonists in mediation and related practices, in the areas of family, organizational, educational, social, legal, among others. Under the coordination of Akira Ninomiya Júnior, the work brings together writers, partners of his social work, the RePacificar Multidimensional, gathered over 5 years of the initiative. The book celebrates the 150th anniversary of Mahatma Gandhi, whose grandson Arun Gandhi is one of the interviewees.
Published: 2019

80. O guia completo das Plantas Medicinais : Ervas de A a Z para tratar doenças, restabelecer a saúde e o bem-estar

Author: David Hoffman and David Hoffman
Subjects: Nutrition, Self-care, Health, Medicinal plants, Herbs--Therapeutic use
Abstract: Neste guia abrangente e bem fundamentado, o médico herbalista David Hoffmann oferece um tratamento natural e sem contraindicações para ajudar você a recuperar e manter a saúde e o bem-estar. Orientações claras e minuciosas mostram como diagnosticar e tratar com segurança uma ampla variedade de distúrbios - desde prisão de ventre, TPM e depressão, rinite, diabetes e tensão nervosa - sem nenhum efeito colateral nocivo. Uma obra para você promover a sua saúde e bem-estar, com um dos tratamentos mais acessíveis e completos que a natureza nos deu.
Published: 2019

81. Effect of veliparib (ABT-888) on cardiac repolarization in patients with advanced solid tumors

Author: Wijith Munasinghe, Hao Xiong, Mathilde Jalving, Anthony W. Tolcher, Judith de Vos-Geelen, Dennis Bergau, David Hoffman, Michael S. Gordon, Emiliano Calvo, Sven Stodtmann, Diane Medina, Stacie Peacock Shepherd, Silpa Nuthalapati, Targeted Gynaecologic Oncology (TARGON), Interne Geneeskunde, MUMC+: MA Medische Oncologie (9), and RS: GROW - R3 - Innovative Cancer Diagnostics & Therapy
Subjects: 0301 basic medicine, Male, Cancer Research, Toxicology, Gastroenterology, PARP1, chemistry.chemical_compound, Electrocardiography, 0302 clinical medicine, Neoplasms, Clinical endpoint, Medicine, Pharmacology (medical), Aged, 80 and over, Cross-Over Studies, Solid tumor, PARP INHIBITORS, Middle Aged, Long QT Syndrome, PHASE-I, Oncology, 030220 oncology & carcinogenesis, Anesthesia, THOROUGH QT, Vomiting, Original Article, Female, medicine.symptom, Algorithms, Adult, QT interval, medicine.medical_specialty, CANCER-THERAPY, Veliparib, Nausea, Endpoint Determination, Poly(ADP-ribose) Polymerase Inhibitors, Placebo, 03 medical and health sciences, Double-Blind Method, Heart Conduction System, Internal medicine, RADIATION-THERAPY, Humans, Adverse effect, COMBINATION, Aged, Pharmacology, Dose-Response Relationship, Drug, Poly(ADP-ribose) polymerase, business.industry, ECG, EFFICACY, Crossover study, 030104 developmental biology, PARP inhibitor, chemistry, Benzimidazoles, business, INHIBITORS
Abstract: Veliparib (ABT-888) is an orally bioavailable potent inhibitor of poly(ADP-ribose) polymerase (PARP)-1 and PARP-2. This phase 1 study evaluated the effect of veliparib on corrected QT interval using Fridericia's formula (QTcF).Eligible patients with advanced solid tumors received single-dose oral veliparib (200 mg or 400 mg) or placebo in a 6-sequence, 3-period crossover design. The primary endpoint was the difference in the mean baseline-adjusted QTcF between 400 mg veliparib and placebo (a dagger a dagger QTcF) at six post-dose time points. Absence of clinically relevant QTcF effect was shown if the 95 % upper confidence bound (UCB) for the mean a dagger a dagger QTcF was Forty-seven patients were enrolled. Maximum mean a dagger a dagger QTcF of veliparib 400 mg was 6.4 ms, with a 95 % UCB of 8.9 ms; for veliparib 200 mg, the maximum mean a dagger a dagger QTcF was 3.6 ms, with a 95 % UCB of 6.1 ms. No patient had a QTcF value > 480 ms or change from baseline in QTcF interval > 30 ms. Treatment-emergent adverse events (TEAEs) were experienced by 36.2, 48.9, and 47.8 % of patients while receiving veliparib 200 mg, veliparib 400 mg, and placebo, respectively. Most common TEAEs were nausea (12.8 %) and myalgia (8.5 %) after veliparib 200 mg, nausea (8.5 %) and vomiting (8.5 %) after veliparib 400 mg, and nausea (6.5 %) after placebo.Single-dose veliparib (200 mg or 400 mg) did not result in clinically significant QTc prolongation and was well tolerated in patients with advanced solid tumors.
Published: 2016
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82. Model averaging inconcentration-QT analyses

Author: David Hoffman, Clémence Rigaux, Bernard Sébastien, Franck Pellissier, and Jerome Msihid
Subjects: Pharmacology, Statistics and Probability, Model selection, Linear model, Context (language use), 030226 pharmacology & pharmacy, 01 natural sciences, Exponential function, 010104 statistics & probability, 03 medical and health sciences, 0302 clinical medicine, Frequentist inference, Applied mathematics, Pharmacology (medical), Treatment effect, 0101 mathematics, Type I and type II errors, Mathematics
Abstract: This article describes how a frequentist model averaging approach can be used for concentration-QT analyses in the context of thorough QTc studies. Based on simulations, we have concluded that starting from three candidate model families (linear, exponential, and Emax) the model averaging approach leads to treatment effect estimates that are quite robust with respect to the control of the type I error in nearly all simulated scenarios; in particular, with the model averaging approach, the type I error appears less sensitive to model misspecification than the widely used linear model. We noticed also few differences in terms of performance between the model averaging approach and the more classical model selection approach, but we believe that, despite both can be recommended in practice, the model averaging approach can be more appealing because of some deficiencies of model selection approach pointed out in the literature. We think that a model averaging or model selection approach should be systematically considered for conducting concentration-QT analyses. Copyright © 2016 John Wiley & Sons, Ltd.
Published: 2016
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83. Helicoidal minimal surfaces of prescribed genus

Author: Brian White, Martin Traizet, David Hoffman, Stanford University, Laboratoire de Mathématiques et Physique Théorique (LMPT), Centre National de la Recherche Scientifique (CNRS)-Université de Tours, and Université de Tours (UT)-Centre National de la Recherche Scientifique (CNRS)
Subjects: Mathematics - Differential Geometry, Minimal surface, 010308 nuclear & particles physics, General Mathematics, media_common.quotation_subject, 010102 general mathematics, Secondary: 49Q05, Radius, 53C42, Infinity, 01 natural sciences, 3. Good health, Combinatorics, Differential Geometry (math.DG), [MATH.MATH-DG]Mathematics [math]/Differential Geometry [math.DG], 53A10 (Primary), 49Q05, 53C42 (Secondary), Genus (mathematics), 0103 physical sciences, FOS: Mathematics, Primary: 53A10, Mathematics::Differential Geometry, 0101 mathematics, Mathematics, media_common
Abstract: For every genus $g$, we prove that $S^2 \times R$ contains complete, properly embedded, genus-$g$ minimal surfaces whose two ends are asymptotic to helicoids of any prescribed pitch. We also show that as the radius of the $S^2$ tends to infinity, these examples converge smoothly to complete, properly embedded minimal surfaces in $R^3$ that are helicoidal at infinity. We prove that helicoidal surfaces in $R^3$ of every prescribed genus occur as such limits of examples in $S^2\times R$., Comment: 87 pages. This paper combines and supersedes our earlier two papers, Helicoidal minimal surfaces of prescribed genus, I and II [arXiv:1304.5861 and arXiv:1304.6180]. This version (16 November, 2016) fixes a few typos
Published: 2016
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84. Erratum to: Development of a Unifying Target and Consensus Indicators for Global Surgical Systems Strengthening: Proposed by the Global Alliance for Surgery, Obstetric, Trauma, and Anaesthesia Care (The G4 Alliance)

Author: Adil Haider, John W. Scott, Colin D. Gause, Mira Meheš, Grace Hsiung, Albulena Prelvukaj, Dana Yanocha, Lauren M. Baumann, Faheem Ahmed, Na’eem Ahmed, Sara Anderson, Herve Angate, Lisa Arfaa, Horacio Asbun, Tigistu Ashengo, Kisembo Asuman, Ruben Ayala, Stephen Bickler, Saul Billingsley, Peter Bird, Matthijs Botman, Marilyn Butler, Jo Buyske, Angelo Capozzi, Kathleen Casey, Charles Clayton, James Cobey, Michael Cotton, Dan Deckelbaum, Miliard Derbew, Catherine deVries, Jeanne Dillner, Max Downham, Natalie Draisin, David Echinard, Sohier Elneil, Ahmed ElSayed, Abigail Estelle, Allen Finley, Erica Frenkel, Philip K. Frykman, Florin Gheorghe, Julian Gore-Booth, Richard Henker, Jaymie Henry, Orion Henry, Laura Hoemeke, David Hoffman, Iko Ibanga, Eric V. Jackson, Pankaj Jani, Walter Johnson, Andrew Jones, Zeina Kassem, Asuman Kisembo, Abbey Kocan, Sanjay Krishnaswami, Robert Lane, Asad Latif, Barbara Levy, Dimitrios Linos, Peter Linz, Louis A. Listwa, Declan Magee, Emmanuel Makasa, Michael L. Marin, Claude Martin, Kelly McQueen, Jamie Morgan, Richard Moser, Robert Neighbor, William M. Novick, Stephen Ogendo, Akinyinka Omigbodun, Bisola Onajin-Obembe, Neil Parsan, Beverly K. Philip, Raymond Price, Shahnawaz Rasheed, Marjorie Ratel, Cheri Reynolds, Steven M. Roser, Jackie Rowles, Lubna Samad, John Sampson, Harshadkumar Sanghvi, Marchelle L. Sellers, David Sigalet, Bruce C. Steffes, Erin Stieber, Mamta Swaroop, John Tarpley, Asha Varghese, Julie Varughese, Richard Wagner, Benjamin Warf, Neil Wetzig, Susan Williamson, Joshua Wood, Anne Zeidan, Lewis Zirkle, Brendan Allen, and Fizan Abdullah
Subjects: Surgery
Published: 2017
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85. Industry Perspective on Standardizing Food-Effect Studies for New Drug Development

Author: Amit Khatri, Mohamad Shebley, Apurvasena Parikh, Walid M. Awni, Silpa Nuthalapati, Patrick J. Marroum, David Hoffman, and Jiuhong Zha
Subjects: Pharmacology, FOOD EFFECT, Statistical design, Drug Industry, United States Food and Drug Administration, Perspective (graphical), 030226 pharmacology & pharmacy, United States, Clinical trial, 03 medical and health sciences, Food-Drug Interactions, 0302 clinical medicine, Dose dumping, Drug development, Risk analysis (engineering), Drug Development, Research Design, 030220 oncology & carcinogenesis, Humans, Pharmacology (medical), Product (category theory), Dosing, Psychology
Abstract: Investigating the effect of food on bioavailability during the development of an oral drug product is of prime importance because it has major implications on the study design of the clinical trials and dosing and administration recommendations. For modified-release formulations that exhibit dose dumping when administered with food, this may result in clinical concerns around safety and efficacy. In this article, we provide an overview of the various considerations in our opinion that impact the design and conduct of food-effect studies. We summarize the various recommendations from the different regulatory agencies and provide specific suggestions on study conduct in terms of statistical design, timing of studies, subject selection, and type and caloric content of the meal. We also discuss the role of modeling and simulation. Finally, we present an interpretation of the results of food-effect studies in addition to dosing and labeling recommendations in relation to regulatory guidance documents.
Published: 2018

86. Care Coordination: Empowering Families, a Promising Practice to Facilitate Medical Home Use Among Children and Youth with Special Health Care Needs

Author: Julie Moore, Gina Gembel, David N. Entwistle, David Hoffman, Kristen Hawkins, and Lisa Gorman Ufer
Subjects: Medical home, Adult, Male, medicine.medical_specialty, From the Field, Epidemiology, Family support, education, Child Health Services, CYSHCN, Special health care needs, Peer support, Pediatrics, Patient Care Planning, 03 medical and health sciences, Families, 0302 clinical medicine, Nursing, Professional-Family Relations, 030225 pediatrics, Patient-Centered Care, Care coordination, Health care, Medicine, Humans, Training, Family, 030212 general & internal medicine, Child, Response rate (survey), Patient Care Team, Health Services Needs and Demand, business.industry, Family caregivers, Public health, Public Health, Environmental and Occupational Health, Obstetrics and Gynecology, Middle Aged, Disabled Children, Child, Preschool, Pediatrics, Perinatology and Child Health, Female, Power, Psychological, business, Program Evaluation
Abstract: Introduction This paper describes the care coordination training program and results of an evaluation from its pilot in seven states. Despite the importance of practice-based care coordination, only 42.3% of children with special health care needs (CYSHCN) met all needed components of care coordination as defined by the Maternal Child Health Bureau. Recognizing that children with medically complex conditions often have lower rates of achieving care coordination within a medical home, the Region 4 Midwest Genetics Collaborative worked with families to develop a training to empower families in care coordination. The Care Coordination: Empowering Families(CCEF) training provides families with the knowledge, tools, and resources to engage with health, education and family support systems. This article gives an overview of the training and comprehensive evaluation. Methods Participants were family caregivers of children with genetic conditions and other special health care needs recruited in one of seven pilot states. Evaluation data were collected from 190 participants prior to and immediately following the training. An additional follow-up assessment one full year post training was completed by 80 participants (a response rate of 42%). Results Families who attended the training report being the primary source of care coordination for their children and 83.7% see their role in their child’s healthcare changing as a result of the training. The findings suggest that peer support and communication with providers increased as a result of the training over the course of the study. The data suggest that the training impacted how the family interacts with the child’s doctor, including initiating conversations to prepare their child for transition to adult health care. Further, families report system-level improvements 1 year later compared to the pre-training assessment. Discussion CCEF training is a promising practice for facilitating medical home use among CYSHCN.
Published: 2018

87. Graphical Translators for Mean Curvature Flow

Author: David Hoffman, Tom Ilmanen, Brian White, and Francisco Martín
Subjects: Discrete mathematics, Mathematics - Differential Geometry, Mean curvature flow, Applied Mathematics, 010102 general mathematics, 01 natural sciences, 53C44, 53C21, 53C42, 010101 applied mathematics, Mathematics - Analysis of PDEs, Differential Geometry (math.DG), FOS: Mathematics, 0101 mathematics, Analysis, Mathematics, Analysis of PDEs (math.AP)
Abstract: In this paper we provide a full classification of complete translating graphs in $\mathbf{R}^3$. We also construct two $(n-1)$-parameter families of new examples of translating graphs in $\mathbf{R}^{n+1}$., Comment: 29 pages, 3 Figures. A few typos have been corrected
Published: 2018
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88. CENOZOIC EXHUMATION OF THE RUBY MOUNTAIN-EAST HUMBOLDT-WOOD HILLS-PEQUOP MOUNTAINS METAMORPHIC CORE COMPLEX: NEW CONSTRAINTS FROM REMNANTS OF PALEOGENE TO NEOGENE EXTENSIONAL BASINS

Author: Robert Hensley, Phyllis A. Camilleri, David Hoffman, Joshua J. Schwartz, Patrick Hackett, and Jack E. Deibert
Subjects: Paleontology, Metamorphic core complex, Neogene, Paleogene, Cenozoic, Extensional definition, Geology
Published: 2018
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89. PROVENANCE OF CENOZOIC DETRITAL ZIRCONS IN THE MIOCENE HUMBOLDT FORMATION IN THE NORTHERN WOOD HILLS, NORTHEASTERN NEVADA: IMPLICATIONS FOR LOCAL SEDIMENTATION IN THE NEVADAPLANO

Author: Patrick Hackett, Joshua J. Schwartz, Jack E. Deibert, Robert Hensley, David Hoffman, and Phyllis A. Camilleri
Subjects: Provenance, Geochemistry, Sedimentation, Cenozoic, Geology
Published: 2018
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90. Dead End Streets: Photography, Protest and Social Control

Author: David Hoffman
Published: 2018
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91. Differentiation of deep venous thrombosis from femoral vein mixing artifact on routine abdominopelvic CT

Author: Andrea S. Kierans, Ankur M. Doshi, Justin M. Ream, Andrew B. Rosenkrantz, and David Hoffman
Subjects: Male, Radiography, Abdominal, medicine.medical_specialty, Urology, Femoral vein, Pelvis, Diagnosis, Differential, medicine, Humans, Radiology, Nuclear Medicine and imaging, Vein, Retrospective Studies, Observer Variation, Venous Thrombosis, Artifact (error), Radiological and Ultrasound Technology, Portal Vein, business.industry, Ultrasound, Gastroenterology, General Medicine, Femoral Vein, Middle Aged, medicine.disease, Catheter, Venous thrombosis, medicine.anatomical_structure, Female, Radiology, Artifacts, Tomography, X-Ray Computed, business, Lower limbs venous ultrasonography
Abstract: The objective of this study is to assess the performance of qualitative and quantitative imaging features for the differentiation of deep venous thrombosis (DVT) from mixing artifact on routine portal venous phase abdominopelvic CT. This retrospective study included 40 adult patients with a femoral vein filling defect on portal venous phase CT and a Duplex ultrasound (n = 36) or catheter venogram (n = 4) to confirm presence or absence of DVT. Two radiologists (R1, R2) assessed the femoral veins for various qualitative and quantitative features. 60% of patients were confirmed to have DVT and 40% had mixing artifact. Features with significantly greater frequency in DVT than mixing artifact (all p ≤ 0.006) were central location (R1 90% vs. 28%; R2 96% vs. 31%), sharp margin (R1 83% vs. 28%; R2 96% vs. 31%), venous expansion (R1 48% vs. 6%, R2 56% vs. 6%), and venous wall enhancement (R1 62% vs. 0%; R2 48% vs. 0%). DVT exhibited significantly lower mean attenuation than mixing artifact (R1 42.1 ± 20.2 vs. 57.1 ± 23.6 HU; R2 43.6 ± 19.4 vs. 58.8 ± 23.4 HU, p ≤ 0.031) and a significantly larger difference in vein diameter compared to the contralateral vein (R1 0.4 ± 0.4 vs. 0.1 ± 0.2 cm; R2 0.3 ± 0.4 vs. 0.0 ± 0.1 cm, p ≤ 0.026). At multivariable analysis, central location and sharp margin were significant independent predictors of DVT for both readers (p ≤ 0.013). Awareness of these qualitative and quantitative imaging features may improve radiologists’ confidence for differentiating femoral vein DVT and mixing artifact on routine portal venous phase CT. However, given overlap with mixing artifact, larger studies remain warranted.
Published: 2015
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92. Her milkshake brings out the girls in Amman: Examining questions about sexual desire and societal influences among same-sex desiring women in Jordan

Author: David Hoffman, Rachel Allison, Kate McClellan, Ostrowski, Caitlin Marlena, David Hoffman, Rachel Allison, Kate McClellan, and Ostrowski, Caitlin Marlena
Abstract: In the Middle East and in many majority Muslim nations, homosexuality, including homosexual acts, identities, desires, and discussions of those, is considered taboo. Utilizing a feminist theoretical orientation, this project examined the ways in which same-sex desiring women in Amman, Jordan view the concept of sexually desiring and its relationship to identities. It also examined the pressures placed on them to abide by and navigate familial and religious expectations that conflict with their sexuality. This project drew upon 15 interviews from Muslim and Christian women in Amman using semi-structured and unstructured interviews and participant observation. After analysis, it was concluded that the majority of informants believe in innate sexual desires and sexuality and that all people sexually desire in similar ways. It was also concluded that informants face more pressure from family than from religion, and therefore, find it easier to balance religious obligations than familial obligations with their sexuality.
Published: 2018

93. Evaluating genetic ancestry and self-reported ethnicity in the context of carrier screening

Author: Jamie Grifo, Shahin Ghadir, Serena H. Chen, Sally Ann Rodríguez, Sonya Elango, A. Manoharan, A. Hershlag, Sara L. Bristow, David Hoffman, S. Yarnall, N. Kumar, R. Shraga, Oscar Puig, Mohammad Niknazar, and Rita Vassena
Subjects: 0301 basic medicine, lcsh:QH426-470, Genetic counseling, Genetic genealogy, Concordance, Genetic Carrier Screening, Ethnic group, Context (language use), Ancestry-informative marker, 030105 genetics & heredity, Biology, Southeast asian, Polymorphism, Single Nucleotide, 03 medical and health sciences, Human Genome Project, Genetics, Ethnicity, Medicine, Humans, Genetics (clinical), Ancestry informative markers, Genetic risk, Models, Genetic, business.industry, Racial Groups, Residual risk, lcsh:Genetics, 030104 developmental biology, Carrier screening, Self Report, business, Demography, Research Article
Abstract: BackgroundCurrent professional society guidelines recommend genetic carrier screening be offered on the basis of ethnicity, or when using expanded carrier screening panels, they recommend to compute residual risk based on ethnicity. We investigated the reliability of self-reported ethnicity in 9138 subjects referred to carrier screening. Self-reported ethnicity gathered from test requisition forms and during post-test genetic counseling, and genetic ancestry predicted by a statistical model, were compared for concordance.ResultsWe identified several discrepancies between the two sources of self-reported ethnicity and genetic ancestry. Only 30.3% of individuals who indicated Mediterranean ancestry during consultation self-reported this on requisition forms. Additionally, the proportion of individuals who reported Southeast Asian but were estimated to have a different genetic ancestry was found to depend on the source of self-report. Finally, individuals who reported Latin American demonstrated a high degree of ancestral admixture. As a result, carrier rates and residual risks provided for patient decision-making are impacted if using self-reported ethnicity.ConclusionOur analysis highlights the unreliability of ethnicity classification based on patient self-reports. We recommend the routine use of pan-ethnic carrier screening panels in reproductive medicine. Furthermore, the use of an ancestry model would allow better estimation of carrier rates and residual risks.
Published: 2017
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94. L-shaped linacs

Author: David Hoffman, Julian Perks, Steve Goetsch, and Stanley Benedict
Published: 2017
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95. Development of a Unifying Target and Consensus Indicators for Global Surgical Systems Strengthening: Proposed by the Global Alliance for Surgery, Obstetric, Trauma, and Anaesthesia Care (The G4 Alliance)

Author: Sanjay Krishnaswami, Charles Clayton, Dana Yanocha, David Sigalet, Jackie Rowles, Ahmed Elsayed, S.W.O. Ogendo, Julian Gore-Booth, Marjorie Ratel, Akinyinka Omigbodun, S. Rasheed, Joshua Wood, Sohier Elneil, Brendan Allen, Natalie Draisin, Anne Zeidan, Colin D. Gause, Dimitrios Linos, David Hoffman, Allen Finley, Neil Parsan, Asha Varghese, Raymond R. Price, Cheri Reynolds, Dan L. Deckelbaum, Steven M. Roser, Asad Latif, Catherine R. deVries, James C. Cobey, John Sampson, Miliard Derbew, Asuman Kisembo, Stephen W. Bickler, Susan Williamson, Tigistu Adamu Ashengo, Laura Hoemeke, Richard Moser, Herve Angate, Robert Neighbor, Albulena Prelvukaj, Declan Magee, Jaymie Ang Henry, Bisola Onajin-Obembe, Grace Hsiung, Richard Henker, Louis A. Listwa, Zeina Kassem, John L. Tarpley, Beverly K. Philip, Abigail Estelle, Jo Buyske, Lauren M. Baumann, Ruben Ayala, John W. Scott, M Botman, Michael Marin, Claude Martin, Walter D. Johnson, Lisa Arfaa, Kisembo Asuman, Neil Wetzig, Julie Varughese, Angelo Capozzi, Richard Wagner, Max Downham, Barbara Levy, Harshadkumar Sanghvi, Iko Ibanga, Andrew T. Jones, Mira Mehes, Emmanuel Makasa, Kelly McQueen, Erin Stieber, Erica Frenkel, Peter Linz, Lewis G. Zirkle, Fizan Abdullah, Bruce C. Steffes, David Echinard, William M. Novick, Jeanne Dillner, Mamta Swaroop, Faheem Ahmed, Jamie Morgan, Benjamin C. Warf, Horacio J. Asbun, Orion Henry, Sara Anderson, Kathleen M. Casey, Florin Gheorghe, Peter Bird, PG Jani, Na’eem Ahmed, Adil H. Haider, Marchelle L. Sellers, Lubna Samad, Saul Billingsley, Abbey Kocan, Michael Cotton, Eric V. Jackson, Robert Lane, Philip K. Frykman, and Marilyn W. Butler
Subjects: medicine.medical_specialty, Capacity Building, Consensus, Commission, Global Health, Health Services Accessibility, 03 medical and health sciences, 0302 clinical medicine, Argument, medicine, Humans, Anesthesia, National level, 030212 general & internal medicine, Scientific Review, Science & Technology, business.industry, Global strategy, 1103 Clinical Sciences, Vascular surgery, SAFE, Surgery, Obstetrics, Alliance, Surgical Procedures, Operative, 030220 oncology & carcinogenesis, Wounds and Injuries, Obstetric trauma, Erratum, International development, business, ACCESS, Goals, Life Sciences & Biomedicine
Abstract: After decades on the margins of primary health care, surgical and anaesthesia care is gaining increasing priority within the global development arena. The 2015 publications of the Disease Control Priorities third edition on Essential Surgery and the Lancet Commission on Global Surgery created a compelling evidenced-based argument for the fundamental role of surgery and anaesthesia within cost-effective health systems strengthening global strategy. The launch of the Global Alliance for Surgical, Obstetric, Trauma, and Anaesthesia Care in 2015 has further coordinated efforts to build priority for surgical care and anaesthesia. These combined efforts culminated in the approval of a World Health Assembly resolution recognizing the role of surgical care and anaesthesia as part of universal health coverage. Momentum gained from these milestones highlights the need to identify consensus goals, targets and indicators to guide policy implementation and track progress at the national level. Through an open consultative process that incorporated input from stakeholders from around the globe, a global target calling for safe surgical and anaesthesia care for 80% of the world by 2030 was proposed. In order to achieve this target, we also propose 15 consensus indicators that build on existing surgical systems metrics and expand the ability to prioritize surgical systems strengthening around the world.
Published: 2017

96. Risk-stratified versus Non-Risk-stratified Diagnostic Testing for Management of Suspected Acute Biliary Obstruction: Comparative Effectiveness, Costs, and the Role of MR Cholangiopancreatography

Author: Stella K. Kang, R. Scott Braithwaite, David Hoffman, Michelle I Kim, and Bart S. Ferket
Subjects: Adult, medicine.medical_specialty, Comparative Effectiveness Research, Cholangiopancreatography, Magnetic Resonance, Cost-Benefit Analysis, Comparative effectiveness research, Contrast Media, Malignancy, Risk Assessment, Sensitivity and Specificity, Endosonography, Mr cholangiopancreatography, 03 medical and health sciences, 0302 clinical medicine, Risk Factors, medicine, Medical imaging, Humans, Radiology, Nuclear Medicine and imaging, Computer Simulation, Aged, medicine.diagnostic_test, business.industry, Decision Trees, Diagnostic test, Magnetic resonance imaging, Middle Aged, medicine.disease, United States, Endoscopy, Choledocholithiasis, 030220 oncology & carcinogenesis, Acute Disease, 030211 gastroenterology & hepatology, Radiology, business, Risk assessment
Abstract: Purpose To analyze the cost-effectiveness of the American Society for Gastrointestinal Endoscopy (ASGE) risk stratification guidelines versus magnetic resonance (MR) cholangiopancreatography-based treatment of patients with possible choledocholithiasis. Materials and Methods A decision-analytic model was constructed to compare cost and effectiveness of three diagnostic strategies for gallstone disease with possible choledocholithiasis: noncontrast MR cholangiopancreatography, contrast material-enhanced MR imaging/MR cholangiopancreatography, and ASGE risk stratification guidelines for diagnostic evaluation recommending endoscopy (high risk), MR cholangiopancreatography (intermediate risk), or no test (low risk). Analysis was performed from a U.S. health system perspective over 1-year and lifetime horizons. The model accounted for benign and malignant causes of biliary obstruction and procedural complications. Cost information was based on Medicare reimbursements. Sensitivity analysis assessed the impact of parameter variability on model results. Results Noncontrast MR cholangiopancreatography was most cost-effective in 45-55-year-old patients (less than $100 000 per quality-adjusted life-year [QALY] gained), while contrast-enhanced MR imaging was favored in younger adults. Risk-stratified testing was less costly than MR cholangiopancreatography, with long-term savings of $1870 and $2068 versus noncontrast and contrast-enhanced MR cholangiopancreatography, respectively, but was also less effective (-0.1814, -0.1831 QALY, respectively). The lifetime incremental cost per QALY for noncontrast MR cholangiopancreatography was $10 311. Contrast-enhanced MR imaging was favored with pretest probabilities of biliary stricture or malignancy 0%-73% for patients aged 20-44 years. For patients older than 55 years, ASGE guidelines maximized QALYs at the lowest cost. Conclusion Although adults older than 55 years of age are optimally evaluated by using ASGE guidelines, younger patients suspected of having acute biliary obstruction likely benefit from MR cholangiopancreatography rather than risk-stratified diagnostic imaging because of improved detection of choledocholithiasis and alternative causes of biliary obstruction. © RSNA, 2017 Online supplemental material is available for this article.
Published: 2017

97. It Takes Data to Protect Data

Author: David Hoffman and Patricia A. Rimo
Subjects: Data flow diagram, Information privacy, business.industry, Computer science, Privacy policy, Internet privacy, Big data, Key (cryptography), Data Protection Act 1998, Information technology, Safeguarding, business
Abstract: We live in a world of constant data flow, and safeguarding data has never been more important. Be it medical records, financial information or simple online passwords, the amount of private data that needs to be protected continues to grow. Along with this growth in the need to secure data, however, are the privacy concerns people have with their data. While some would pit security and privacy against each other, arguing that individuals must choose one over the other, the two actually can and should reinforce each other. It’s this model that forms the basis of this chapter: Privacy and security should be pursued hand-in-hand as we move toward an increasingly connected, digital world. To fully realize the benefits of information technology, big data and IoT, individuals must be confident that their devices are designed in a way that protects their data and that any data being collected and processed from those devices is used responsibly. Using internationally recognized mechanisms such as the Fair Information Privacy Principles, public and private organizations can enable both the innovative AND ethical use of data. The key is not avoiding data but using it mindfully. It takes data to protect data.
Published: 2017
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98. A Phase II, Open-Label Study of Ramucirumab in Combination with Paclitaxel and Carboplatin as First-Line Therapy in Patients with Stage IIIB/IV Non–Small-Cell Lung Cancer

Author: Sergey Yurasov, Missak Haigentz, Thierry Jahan, Marc S Ballas, Robert C. Doebele, Eamon M. Berge, Pablo Lee, Howard West, Ling Gao, David Hoffman, Adarsh Joshi, Ling Yang, D. Ross Camidge, Alain C. Mita, and James Spicer
Subjects: Adult, Male, Pulmonary and Respiratory Medicine, Oncology, medicine.medical_specialty, Lung Neoplasms, Paclitaxel, Bevacizumab, medicine.medical_treatment, Antibodies, Monoclonal, Humanized, Disease-Free Survival, Ramucirumab, Carboplatin, chemistry.chemical_compound, Carcinoma, Non-Small-Cell Lung, Internal medicine, Antineoplastic Combined Chemotherapy Protocols, medicine, Clinical endpoint, Humans, Lung cancer, Adverse effect, Aged, Neoplasm Staging, Chemotherapy, business.industry, Area under the curve, Antibodies, Monoclonal, Original Articles, Middle Aged, medicine.disease, Non-Small Cell Lung Cancer, Surgery, chemistry, Female, Angiogenesis, business, medicine.drug
Abstract: Introduction The objective of this study was to determine whether the addition of ramucirumab to first-line paclitaxel–carboplatin chemotherapy in patients with advanced non–small-cell lung cancer (NSCLC) resulted in a 6-month progression-free survival (PFS) rate that compares favorably with the historic rate for bevacizumab combined with paclitaxel–carboplatin in this patient population. Methods In this phase II, single-arm, open-label, multicenter study, 40 patients with advanced NSCLC received ramucirumab (10 mg/kg intravenous [IV]) followed by paclitaxel (200 mg/m 2 IV) and carboplatin area under the curve=6 on day 1 every 21 days as first-line therapy. Therapy continued for up to six cycles. Patients not experiencing withdrawal criteria may have continued ramucirumab monotherapy every 3 weeks. The primary endpoint was PFS at 6 months, with 80% power to detect a 6-month PFS rate of at least 55%. Results The 6-month PFS rate was 59.0% and the objective response rate was 55.0%. The most common treatment-related adverse events were fatigue, peripheral neuropathy, nausea, epistaxis, and myalgia. Single-nucleotide polymorphism (SNP) rs2981582 on the FGFR-2 gene had significant associations with improved overall survival, PFS, and best overall response ( p values without multiplicity adjustment were 0.0059, 0.0429, and 0.0392, respectively). Conclusion Ramucirumab in combination with paclitaxel–carboplatin resulted in a 6-month PFS rate and safety profile that compared favorably with the historical control. In addition, no deaths were associated with this treatment. Furthermore, we describe an association of SNP on FGFR-2 gene with survival and response. These findings warrant further clinical investigation in patients with NSCLC.
Published: 2014
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99. Circadian Variation and Baseline Definition in Parallel-Group Thorough QT Studies

Author: David Hoffman
Subjects: Analysis of covariance, Variation (linguistics), Covariate, Statistics, Public Health, Environmental and Occupational Health, Pharmacology (medical), Circadian rhythm, Baseline (configuration management), Pharmacology, Toxicology and Pharmaceutics (miscellaneous), QT interval, Drug effect, Mathematics, Type I and type II errors
Abstract: For thorough QT (TQT) studies employing a parallel-group design, there has been a clear regulatory preference for the use of time-matched, rather than time-averaged, baseline values to account for circadian variation when estimating the magnitude of the drug effect on the QT interval. In this paper, both historical data from parallel-group TQT studies and simulated data from assumed circadian models are utilized to comprehensively assess the performance characteristics of 3 repeated-measures analysis of covariance models. The results indicate that each analysis model performs adequately in the absence of an observed time-matched baseline imbalance between the treatment groups. However, the analysis model with time-matched baseline as a covariate performs poorly under the setting of an observed time-matched baseline imbalance between the treatment groups. The analysis model with time-averaged baseline as a covariate and the analysis model with both time-matched and time-averaged baselines as covariates provide unbiased estimates of the treatment difference and properly control the type I error rate, regardless of an observed time-matched baseline imbalance or within-patient variation in circadian parameters.
Published: 2014
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100. Highly stable intrinsically radiolabeled indium-111 quantum dots with multidentate zwitterionic surface coating: dual modality tool for biological imaging

Author: Jamal Zweit, Narottam Lamichhane, Purnima Jose, Gobalakrishnan Sundaresan, Minghao Sun, David Hoffman, and Likun Yang
Subjects: Fluorescence-lifetime imaging microscopy, Materials science, Biomedical Engineering, Analytical chemistry, General Chemistry, General Medicine, Surface coating, Epidermoid carcinoma, In vivo, Spect imaging, Fluorescence microscope, Biophysics, General Materials Science, Biological imaging, Ex vivo
Abstract: Here we describe a novel strategy to incorporate indium-111 into near infrared (NIR) emitting Cu–In–Se quantum dots (CIS-QDs) to synthesize intrinsically radiolabeled QDs (rQDs), as a quantitative tool for in vivo SPECT/fluorescence imaging. Multidentate zwitterionic polymer ligands were used to functionalize and improve the stability of CIS-rQDs and reduce nonspecific binding with plasma proteins/cell membrane. CIS-rQDs were taken up by colorectal adenocarcinoma (COLO-205) and human epidermoid carcinoma (KB-3-1) cells at low uptake rate (∼0.4%, 2 × 105 QDs per cell at 24 h) and reduced nonspecific interaction of zwitterionic CIS-rQDs with cells was observed by fluorescence microscopy. The cytotoxicity of CIS-rQDs was reduced due to the low toxic inorganic composition of QDs and multidentate zwitterionic surface coating. In 5 out of 6 nude mice bearing either COLO-205 or KB-3-1 tumor, both SPECT and fluorescence imaging demonstrated passive localization of CIS-rQDs in the tumor as early as 6 h post-injection. In these mice the passive accumulation of CIS-rQDs in the tumor, due to leaky vasculature, ranged from ∼0.3% ID per g to ∼4.6% ID per g at 48 h post-injection (from region of interest analysis of SPECT imaging). This intrinsic radio-labeling strategy provides a nanoparticle platform which incorporates imaging and potentially therapeutic radionuclides with retention of fluorescence intensity. It also provides complimentary quantitative data capabilities for both in vivo SPECT imaging and radiotracer ex vivo analysis.
Published: 2014
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