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1. Reoxidation Behavior of the Direct Reduced Iron and Hot Briquetted Iron during Handling and Their Integration into Electric Arc Furnace Steelmaking: A Review

Author

Lina Kieush, Stefanie Lesiak, Johannes Rieger, Melanie Leitner, Lukas Schmidt, and Oday Daghagheleh

Subjects
direct reduced iron, hot briquetted iron, reoxidation, electric arc furnace, steelmaking, Mining engineering. Metallurgy, TN1-997
Abstract

This paper studies the integration of direct reduced iron (DRI) and hot briquetted iron (HBI) into the steelmaking process via an electric arc furnace (EAF). Considering a variety of DRI production techniques distinguished by different reactor types, this paper provides a comparative overview of the current state. It delves into significant challenges, such as the susceptibility of DRI to reoxidation and the necessity of thorough handling to maintain its quality. The effectiveness of several reoxidation mitigation strategies, including the application of thin oxide layers, briquetting, various coatings, and nitride formation in ammonia-based reduction processes, is evaluated. Most existing studies have primarily focused on the reoxidation of DRI rather than on HBI, despite the fact that HBI may undergo reoxidation. The importance of DRI/HBI in offering an alternative to the integrated steelmaking route is highlighted, focusing on how it changes the EAF process compared to those for melting scrap. This paper also identifies several research prospects for further DRI/HBI applications in steel production.

Published
2024
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2. Results from the first four regimens of the HEALEY ALS Platform Trial (PL5.004)

Author

Sabrina Paganoni, James Berry, Melanie Quintana, Eric Macklin, Benjamin Saville, Jinsy Andrews, Jeremy Shefner, Christina Fournier, Suma Babu, Nicholas Maragakis, Bjorn Oskarsson, Michelle Detry, Marianne Chase, Alex Sherman, Hong Yu, Lindsay Pothier, Kristin Drake, Lori Chibnik, Marie-Abele Bind, Matteo Vestrucci, Anna McGlothlin, Joseph Marion, Petra Duda, Brittany Harvey, Irfan Qureshi, Mary Donohue, Volkan Granit, Katheryn Grossman, Robert Glanzman, Michael Hotchkin, Y Paul Goldberg, Melanie Leitner, Michael Hayden, and Merit Cudkowicz

Published
2023
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4. Innovative funding models for neurotherapeutics

Author

Neta Zach and Melanie Leitner

Subjects
Government, Incentive, Drug development, business.industry, Venture philanthropy, Funding Mechanism, Venture capital, Public relations, Investment (macroeconomics), business, health care economics and organizations, Mirroring
Abstract

This book describes various innovations in the neurotherapeutic space, but an underlying challenge throughout all of these stories of brain disease-related breakthroughs is the challenge of funding. Since the 1940s and the days of Vannevar Bush, Director of the Office of Science Research and Development a , research has primarily been considered to be either fundamental or applied in nature, the former being largely funded by the government and the nonprofit sector and the latter being largely funded by industry. CNS drug development is particularly expensive given the complexity of the brain, the need to deliver pharmaceuticals across the blood–brain barrier, the heterogeneity of many brain-based diseases, the difficulty of mirroring human brain biology and pathology using primarily rodent models, and the resulting long timelines required for approval. Therefore, in spite of enormous unmet need, the industry has periodically chosen to exit CNS drug development in pursuit of more tractable indications, creating funding challenges for corporate and academic research efforts. While funding challenges are not unique to CNS therapeutic development, there has been considerable innovation in the development of novel funding mechanisms for brain-related diseases over the past 15 years, including the launch of incentive prizes, venture philanthropy efforts, and creation of disease-focused venture capital-based social impact investment funds. Each of these models can play a unique, complementary, and valuable role in accelerating the development of neurotherapeutics.

Published
2021
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5. Contributors

Author

Karen Aboody, Olubankole Aladesuyi Arogundade, Giovanni Appendino, Weiqi Bao, Marco A.S. Baptista, Danielle Beaulieu, Frank Bennett, Emma Brand, Don Cleveland, Stanley L. Cohan, Jonavelle Cuerdo, Jim DeMesa, David L. Ennist, Meryem Guler, Nada Hindiyeh, Hanna Hovren, Yiyun Henry Huang, Hongmei Jia, Jie Jiang, Brian K. Kaspar, Petra Kaufmann, Randall Kaye, Jeffery W. Kelly, Mike Keymer, Doo Yeon Kim, Kiren Kresa-Reahl, Ikjae Lee, Melanie Leitner, Stefanie N. Linch, Elisabeth B. Lucassen, Timothy Miller, Rachael Mooney, Gaetano Morello, Eduardo Muñoz, Michael Murray, Hoi Wa Ngai, Joseph Park, Dustin Pierce, Jana Portnow, Evan T. Powers, Luisa Quinti, John Ravits, Meghan Romba, Rajesh Sampath, S. Pablo Sardi, Mark Schactman, Mohammad Shahnawaz, Richard A. Smith, Kyle E. Smoot, Claudio Soto, Clive N. Svendsen, Soshana P. Svendsen, Rudolph E. Tanzi, Albert A. Taylor, Gil I. Wolfe, Clinton B. Wright, Gerald Yakatan, and Neta Zach

Published
2021
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6. ALSUntangled No. 36: Accilion

Author

Gary L. Pattee, Muddasir Quereshi, Paul Wicks, Todd Levine, Chafic Karam, Edor Kabashi, Christen Shoesmith, Jonathan Goldstein, John T. Kissel, Jim Wymer, Fernando G. Vieira, Pamela Kittrell, Carmel Armon, Josep Gamez, Laurie Gutmann, Lisa Kinsley, Gleb Levitsky, Katherine Tindall, Janice Robertson, Yunxia Wang, Emma Fixsen, Carlayne E. Jackson, Stacy A. Rudnicki, Michael Benatar, Robert Bowser, Robin Conwit, Michael J. Strong, Bjorn Oskarsson, Rob Goldstein, Eric J. Sorenson, Alexander Sherman, Neta Zach, Kathy Mitchell, Peter M Andersen, Ahmad Ghavanini, Kristiana Salmon, Richard Bedlack, Nicholas J. Maragakis, Bonnie Gerecke, Jeffrey D. Rothstein, Leo McClusky, Paul E. Barkhaus, Efrat Carmi, Ginna Gonzalez, Jonathan Licht, Steve Perrin, Hiroshi Mitsumoto, Brett M. Morrison, Meraida Polak, Melanie Leitner, Tahseen Mozaffar, Lyle Ostrow, Orla Hardiman, Lorne Zinman, Daniel M. Pastula, Michael H. Rivner, Mazen M. Dimachkie, Steven Nash, Megan Grosso, Ashok Verma, James Heywood, Vivian E. Drory, Erik P. Pioro, Larry Phillips, Gregory T. Carter, Michael D. Weiss, Nazem Atassi, Jeffrey V. Rosenfeld, Khema Sharma, Yvonne Baker, Jon Baker, Christina Fournier, Kevin Boylan, Mark Bromberg, Tulio E. Bertorini, L. P. Rowland, Eric Valor, Sith Sathornsumetee, Rup Tandan, Colin Quinn, Jeremy M. Shefner, James A. Russell, Steve Kolb, Steven Novella, James Caress, Robert G. Miller, Mieko Ogino, George Sachs, Jonathan D. Glass, David Saperstein, Dan Moore, John Ravits, Terry Heiman-Patterson, Dallas Forshew, Catherine Lomen-Hoerth, Daniel MacGowan, Kate Dalton, Merit Cudkowicz, and Noah Lechtzin

Subjects
Risk, 0301 basic medicine, Clinical Trials as Topic, Pathology, medicine.medical_specialty, business.industry, Amyotrophic Lateral Sclerosis, medicine.disease, 03 medical and health sciences, Treatment Outcome, 030104 developmental biology, 0302 clinical medicine, Neurology, medicine, Animals, Humans, Neurology (clinical), Amyotrophic lateral sclerosis, business, 030217 neurology & neurosurgery
Published
2016
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7. Stratification of amyotrophic lateral sclerosis patients: a crowdsourcing approach

Author

Donna N. Dillenberger, Raquel Norel, Merit Cudkowicz, Adriano Chiò, Guang Li, Nazem Atassi, Barbara Di Camillo, Lara M. Mangravite, Robert Kueffner, Neta Zach, Venkatachalapathy S. K. Balagurusamy, Melanie Leitner, Gustavo Stolovitzky, Maya Bronfeld, Joshua W. Knight, Orla Hardiman, Javier Garcia-Garcia, Liuxia Wang, Thea Norman, Jinfeng Xiao, Bruce Hoff, Wen-Chieh Fang, and Jian Peng

Subjects
medicine.medical_specialty, Sub populations, business.industry, Disease, Crowdsourcing, medicine.disease, Stratification (mathematics), Clinical trial, Covert, medicine, Amyotrophic lateral sclerosis, Intensive care medicine, business, Cluster analysis
Abstract

Amyotrophic lateral sclerosis (ALS) is a fatal neurodegenerative disease with substantial heterogeneity in clinical presentation with an urgent need for better stratification tools for clinical development and care. In this study we used a crowdsourcing approach to address the problem of ALS patient stratification. The DREAM Prize4Life ALS Stratification Challenge was a crowdsourcing initiative using data from >10,000 patients from completed ALS clinical trials and 1479 patients from community-based patient registers. Challenge participants used machine learning and clustering techniques to predict ALS progression and survival. By developing new approaches, the best performing teams were able to predict disease outcomes better than currently available methods. At the same time, the integration of clustering components across methods led to the emergence of distinct consensus clusters, separating patients into four consistent groups, each with its unique predictors for classification. This analysis reveals for the first time the potential of a crowdsourcing approach to uncover covert patient sub-populations, and to accelerate disease understanding and therapeutic development.

Published
2018
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8. ALSUntangled No. 35: Hyperbaric Oxygen Therapy*

Author

Lisa Kinsley, Christen Shoesmith, Steven Nash, Peter M Andersen, John T. Kissel, Daniel M. Pastula, Josep Gamez, Nicholas J. Maragakis, Michael H. Rivner, Michael D. Weiss, Jeffrey V. Rosenfeld, James A. Russell, Kathy Mitchell, Steve Kolb, Melanie Leitner, Jim Wymer, Larry Phillips, Jon Baker, Jeffrey D. Rothstein, Erik P. Pioro, Katherine Tindall, Khema Sharma, Stacy A. Rudnicki, Jonathan D. Glass, James Caress, Janice Robertson, Meraida Polak, Tulio E. Bertorini, Paul Wicks, Yunxia Wang, Carlayne E. Jackson, L. P. Rowland, Megan Grosso, Bjorn Oskarsson, Carmel Armon, Leo McClusky, David Saperstein, Lorne Zinman, Laurie Gutmann, Gregory T. Carter, Robert Bowser, Gary L. Pattee, Kristiana Salmon, Brett M. Morrison, Richard Bedlack, Fernando G. Vieira, Orla Hardiman, Edor Kabashi, Sith Sathornsumetee, Vivian E. Drory, Jeremy M. Shefner, Emma Fixsen, Robert G. Miller, Steve Perrin, Michael Benatar, Hiroshi Mitsumoto, Alexander Sherman, Colin Quinn, Todd Levine, Neta Zach, Christina Fournier, Jonathan Goldstein, Lyle Ostrow, Mark Bromberg, Terry Heiman-Patterson, Dallas Forshew, Steven Novella, Mieko Ogino, George Sachs, John Ravits, Dan Moore, James Heywood, Merit Cudkowicz, Noah Lechtzin, Catherine Lomen-Hoerth, Daniel MacGowan, Kate Dalton, Ashok Verma, Yvonne Baker, Muddasir Quereshi, Kevin Boylan, Pamela Kittrell, Gleb Levitsky, Eric J. Sorenson, Robin Conwit, Rob Goldstein, Eric Valor, Rup Tandan, Nazem Atassi, Ahmad Ghavanini, Paul E. Barkhaus, Ginna Gonzalez, Efrat Carmi, Tahseen Mozaffar, Chafic Karam, Mazen M. Dimachkie, Michael J. Strong, Jonathan Licht, and Bonnie Gerecke

Subjects
Complementary Therapies, Male, 0301 basic medicine, Mice, Mice, Neurologic Mutants, 03 medical and health sciences, Clinical Trials, Phase II as Topic, 0302 clinical medicine, Hyperbaric oxygen, Animals, Humans, Medicine, Single-Blind Method, Amyotrophic lateral sclerosis, Hyperbaric Oxygenation, Clinical Trials, Phase I as Topic, business.industry, Amyotrophic Lateral Sclerosis, medicine.disease, Disease Models, Animal, Oxidative Stress, Treatment Outcome, 030104 developmental biology, Neurology, Anesthesia, Neurology (clinical), business, 030217 neurology & neurosurgery
Published
2016
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9. ALSUntangled: Introducing The Table of Evidence

Author

Hubert Kwieciński, Dan Moore, Gary L. Pattee, Edor Kabashi, Chafic Karam, James Caress, Ashok Verma, Brett M. Morrison, Mieko Ogino, George Sachs, Orla Hardiman, Bonnie Gerecke, Vivian E. Drory, Hiroshi Mitsumoto, Gleb Levitsky, Josep Gamez, James Heywood, Nazem Atassi, Michael D. Weiss, Jeffrey V. Rosenfeld, Colin Quinn, Kathy Mitchell, Robin Conwit, Steven Novella, Mark B. Bromberg, Lewis P. Rowland, Jerry M. Belsh, Michael J. Strong, Todd Levine, Jonathan D. Glass, Yunxia Wang, Carlayne E. Jackson, Jon Baker, Muddasir Quereshi, Melanie Leitner, David Saperstein, Carmel Armon, Leo McClusky, Jonathan Licht, Terry Heiman-Patterson, Dallas Forshew, Laurie Gutmann, Pamela Kittrell, Jonathan Goldstein, Khema Sharma, Alexander Sherman, Efrat Carmi, Tahseen Mozaffar, James A. Russell, Merit Cudkowicz, Meraida Polak, Lorne Zinman, Michael Benatar, Jim Wymer, Christina Fournier, Noah Lechtzin, Eric Valor, Mazen M. Dimachkie, Steve Kolb, Megan Grosso, Katherine Tindall, Gregory T. Carter, Stacy A. Rudnicki, Lyle Ostrow, Eric J. Sorenson, Jeffrey D. Rothstein, Robert Bowser, Bjorn Oskarsson, Rup Tandan, Catherine Lomen-Hoerth, Daniel MacGowan, Peter M Andersen, Kate Dalton, Daniel M. Pastula, Craig Oster, Paul Wicks, Richard Bedlack, Michael H. Rivner, Nicholas J. Maragakis, John Ravits, Erik P. Pioro, Christen Shoesmith, John T. Kissel, Tulio E. Bertorini, Jeremy M. Shefner, Paul E. Barkhaus, Kevin Boylan, Jeff Dietz, Ginna Gonzalez, Sith Sathornsumetee, Larry Phillips, Steven Nash, Robert G. Miller, Janice Robertson, and Lisa Kinsley

Subjects
PubMed, medicine.medical_specialty, Evidence-Based Medicine, Physical medicine and rehabilitation, Neurology, business.industry, Amyotrophic Lateral Sclerosis, Humans, Medicine, Table (landform), Neurology (clinical), business
Published
2014
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10. ALSUntangled No. 29: MitoQ

Author

Muddasir Quereshi, Bjorn Oskarsson, Peter M Andersen, Pamela Kittrell, Mark B. Bromberg, Gleb Levitsky, Richard Bedlack, Nicholas J. Maragakis, Leo McClusky, Michael J. Strong, Robin Conwit, Lewis P. Rowland, Efrat Carmi, Tahseen Mozaffar, Alexander Sherman, Mazen M. Dimachkie, Yunxia Wang, Megan Grosso, Brett M. Morrison, Carlayne E. Jackson, Eric J. Sorenson, Craig Oster, John Ravits, Meraida Polak, Orla Hardiman, Hubert Kwieciński, Terry Heiman-Patterson, Dallas Forshew, Christina Fournier, Jonathan Licht, Dan Moore, Carmel Armon, Gregory T. Carter, Gary L. Pattee, James Heywood, Katherine Tindall, Stacy A. Rudnicki, Edor Kabashi, Laurie Gutmann, Jonathan D. Glass, David Saperstein, Chafic Karam, Kevin Boylan, Daniel M. Pastula, Lorne Zinman, Lisa Kinsley, Eric Valor, Michael H. Rivner, Kathy Mitchell, Neta Zach, James A. Russell, Vivian E. Drory, Melanie Leitner, James Caress, Khema Sharma, Rup Tandan, Colin Quinn, Steven Novella, Ashok Verma, Larry Phillips, Catherine Lomen-Hoerth, Daniel MacGowan, Jim Wymer, Michael Benatar, Kate Dalton, Steve Kolb, Michael D. Weiss, Jeffrey V. Rosenfeld, Nazem Atassi, Robert Bowser, Jon Baker, Merit Cudkowicz, Noah Lechtzin, Jeffrey D. Rothstein, Paul Wicks, Steven Nash, Christen Shoesmith, John T. Kissel, Josep Gamez, Bonnie Gerecke, Hiroshi Mitsumoto, Janice Robertson, Paul E. Barkhaus, Ginna Gonzalez, Mieko Ogino, George Sachs, Todd Levine, Jonathan Goldstein, Jeremy M. Shefner, Tulio E. Bertorini, Robert G. Miller, Sith Sathornsumetee, Lyle Ostrow, Erik P. Pioro, and Jeff Dietz

Subjects
Pathology, medicine.medical_specialty, Ubiquinone, business.industry, Amyotrophic Lateral Sclerosis, Drug Evaluation, Preclinical, medicine.disease, Antioxidants, Disease Models, Animal, Oxidative Stress, Organophosphorus Compounds, Neurology, Animals, Humans, Medicine, Neurology (clinical), Amyotrophic lateral sclerosis, business
Published
2015
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11. ALS Untangled No. 20: The Deanna Protocol

Author

Muddasir Quereshi, Pamela Kittrell, Jonathan D. Glass, Efrat Carmi, David Saperstein, Lisa Kinsley, Mark B. Bromberg, Christina Fournier, James Heywood, Eric Valor, Leo McClusky, Rup Tandan, Lyle Ostrow, Eric J. Sorenson, Jim Wymer, Noah Lechtzin, Megan Grosso, Carmel Armon, Todd Levine, Paul E. Barkhaus, Laurie Gutmann, Nazem Atassi, Ginna Gonzalez, Mazen M. Dimachkie, Daniel M. Pastula, Steven Nash, Tahseen Mozaffar, James A. Russell, Robert G. Miller, Hubert Kwieciński, Dan Moore, Michael H. Rivner, Ashok Verma, Craig Oster, John Ravits, Steve Kolb, Jonathan Goldstein, Robert Bowser, Steven Novella, Gregory T. Carter, Michael Benatar, Tulio E. Bertorini, Larry Phillips, Yunxia Wang, Carlayne E. Jackson, Kathy Mitchell, Orla Hardiman, Janice Robertson, Sith Sathornsumetee, Jeffrey D. Rothstein, Melanie Leitner, Lewis P. Rowland, Vivian E. Drory, James B. Caress, Jeremy M. Shefner, Mieko Ogino, George Sachs, Alexander Sherman, Michael J. Strong, Catherine Lomen-Hoerth, Paul Wicks, Erik P. Pioro, Daniel MacGowan, Terry Heiman-Patterson, Kevin B. Boylan, Bjorn Oskarsson, Dallas Forshew, Jonathan Licht, Josep Gamez, Katherine Tindall, Kate Dalton, Gleb Levitsky, Richard Bedlack, Hiroshi Mitsumoto, Gary L. Pattee, Jeff Dietz, Stacy A. Rudnicki, Bonnie Gerecke, Edor Kabashi, Robin Conwit, Peter M Andersen, Nicholas J. Maragakis, Meraida Polak, Michael D. Weiss, Jeffrey V. Rosenfeld, Jon Baker, Christen Shoesmith, John T. Kissel, and Khema Sharma

Subjects
medicine.medical_specialty, business.industry, Amyotrophic Lateral Sclerosis, medicine.disease, Physical medicine and rehabilitation, Neurology, Dietary Supplements, Coconut Oil, Animals, Humans, Plant Oils, Medicine, Nutrition Therapy, Neurology (clinical), Amyotrophic lateral sclerosis, business, Protocol (object-oriented programming)
Published
2013
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12. ALSUntangled 38: L-serine

Author

John Ravits, Jonathan D. Glass, David Saperstein, Ahmad Ghavanini, Erik P. Pioro, Efrat Carmi, Tahseen Mozaffar, Bjorn Oskarsson, Steven Nash, Kristiana Salmon, Richard Bedlack, Christina Fournier, Muddasir Quereshi, Pamela Kittrell, Eric J. Sorenson, Michael Benatar, Todd Levine, Jim Wymer, Carmel Armon, Laurie Gutmann, Jonathan Goldstein, Peter M Andersen, Michael D. Weiss, Lisa Kinsley, Paul Wicks, Jeffrey V. Rosenfeld, Ceri Weber, Ashok Verma, Nazem Atassi, Robert G. Miller, Robert Bowser, Josep Gamez, Bonnie Gerecke, Nicholas J. Maragakis, Brett M. Morrison, Megan Grosso, Gary L. Pattee, Orla Hardiman, Janice Robertson, Jon Baker, Edor Kabashi, Gregory T. Carter, Vivian E. Drory, Neta Zach, Merit Cudkowicz, Noah Lechtzin, Colin Quinn, Catherine Lomen-Hoerth, Daniel MacGowan, Terry Heiman-Patterson, Dallas Forshew, Eric Valour, Kate Dalton, Jeremy M. Shefner, James Heywood, Gleb Levitsky, Alexander Sherman, Robin Conwit, Rob Goldstein, Michael J. Strong, Katherine Tindall, Jeffrey D. Rothstein, Stacy A. Rudnicki, James A. Russell, Steve Kolb, Jonathan Licht, Chafic Karam, Steve Perrin, Hiroshi Mitsumoto, Lyle Ostrow, Leo McClusky, Yunxia Wang, Carlayne E. Jackson, Daniel M. Pastula, Michael H. Rivner, Larry Phillips, Rup Tandan, Paul E. Barkhaus, Ginna Gonzalez, Tulio E. Bertorini, L. P. Rowland, Yvonne Baker, Sith Sathornsumetee, Kevin Boylan, Mark Bromberg, Dan Moore, Fernando G. Vieira, Kathy Mitchell, Melanie Leitner, Mazen M. Dimachkie, James Caress, Meraida Polak, Lorne Zinman, Veronica Peschansky, Christen Shoesmith, John T. Kissel, Khema Sharma, Steven Novella, Emma Fixen, Keeli Hope Denson, Mieko Ogino, and George Sachs

Subjects
0301 basic medicine, Risk, Clinical Trials as Topic, Amyotrophic Lateral Sclerosis, L serine, Biology, medicine.disease, Molecular biology, 03 medical and health sciences, 030104 developmental biology, 0302 clinical medicine, Treatment Outcome, Neurology, medicine, Serine, Humans, Neurology (clinical), Amyotrophic lateral sclerosis, 030217 neurology & neurosurgery
Published
2016

13. Serum urate at trial entry and ALS progression in EMPOWER

Author

Michael A. Schwarzschild, Alberto Ascherio, Dawei Liu, Éilis J. O’Reilly, Merit Cudkowicz, Sabrina Paganoni, Melanie Leitner, and Donald R. Johns

Subjects
0301 basic medicine, Adult, Male, medicine.medical_specialty, Adolescent, International Cooperation, Antioxidants, Article, 03 medical and health sciences, chemistry.chemical_compound, Young Adult, 0302 clinical medicine, Pramipexole, Sex Factors, Double-Blind Method, Internal medicine, medicine, Humans, Benzothiazoles, Survival analysis, Aged, Aged, 80 and over, business.industry, Hazard ratio, Amyotrophic Lateral Sclerosis, Middle Aged, Survival Analysis, Confidence interval, Surgery, Uric Acid, 030104 developmental biology, Neurology, Quartile, chemistry, Disease Progression, Uric acid, Population study, Female, Neurology (clinical), business, Body mass index, Dexpramipexole, 030217 neurology & neurosurgery, medicine.drug, Follow-Up Studies
Abstract

Our objective was to determine whether serum urate predicts ALS progression. A study population comprised adult participants of EMPOWER (n = 942), a phase III clinical trial to evaluate the efficacy of dexpramipexole to treat ALS. Urate was measured in blood samples collected during enrollment as part of the routine block chemistry. We measured outcomes by combined assessment of function and survival rank (CAFs), and time to death, by 12 months. Results showed that in females there was not a significant relation between urate and outcomes. In males, outcomes improved with increasing urate (comparing highest to lowest urate quartile: CAFS was 53 points better with p for trend = 0.04; and hazard ratio for death was 0.60 with p for trend = 0.07), but with adjustment for body mass index (BMI) at baseline, a predictor of both urate levels and prognosis, associations were attenuated and no longer statistically significant. Overall, participants with urate levels equal to or above the median (5.1 mg/dl) appeared to have a survival advantage compared to those below (hazard ratio adjusted for BMI: 0.67; 95% confidence interval 0.47-0.95). In conclusion, these findings suggest that while the association between urate at baseline and ALS progression is partially explained by BMI, there may be an independent beneficial effect of urate.

Published
2016

14. Quantitative strength testing in ALS clinical trials

Author

Toby A. Ferguson, David A. Schoenfeld, Donald R. Johns, Dawei Liu, Melanie Leitner, Jeremy M. Shefner, and Merit Cudkowicz

Subjects
0301 basic medicine, Male, Muscle Strength Dynamometer, medicine.medical_specialty, Coefficient of variation, Article, law.invention, 03 medical and health sciences, 0302 clinical medicine, Physical medicine and rehabilitation, Pramipexole, Randomized controlled trial, law, Outcome Assessment, Health Care, Medicine, Strength testing, Humans, Benzothiazoles, Amyotrophic lateral sclerosis, business.industry, Amyotrophic Lateral Sclerosis, Ceftriaxone, medicine.disease, Clinical trial, 030104 developmental biology, Body region, Female, Neurology (clinical), business, Dexpramipexole, 030217 neurology & neurosurgery, medicine.drug
Abstract

Objective: To study the attributes of quantitative strength testing using hand-held dynamometry (HHD) as an efficacy measure in 2 large phase 3 amyotrophic lateral sclerosis (ALS) trials. Methods: In the phase 3 trials of ceftriaxone and dexpramipexole, 513 and 943 patients, respectively, were enrolled in double-blind, randomized, placebo-controlled trials with planned follow-up of at least 1 year. Patients were studied every 3 months in the ceftriaxone study and every 2 months in the dexpramipexole study. Evaluators of HHD were trained and had to show evidence of adequate performance of strength testing; the testing paradigm involved testing 9 muscle groups in the upper and lower extremity bilaterally. Neither drug significantly affected any outcome measure. Strength measurements were evaluated by individual muscle and by megascores, which averaged scaled strength measures to produce an overall measure of muscle strength. Results: A measure combining rate of decline with both within- and between-patient variabilities of measurement, the coefficient of variation for rate of change, was calculated, and showed that HHD overall performed slightly less well than Amyotrophic Lateral Sclerosis Functional Rating Scale–revised (ALSFRS-R) but better than vital capacity. Individual muscles were highly correlated to the identical muscles on the contralateral side, as well as to other muscles in the same body region. Strength decline was correlated both with ALSFRS-R and vital capacity. Conclusion: Quantitative strength testing using HHD is a reliable and reproducible measure of decline in ALS.

Published
2016

15. ALSUntangled No. 34: GM604

Author

Yvonne Baker, Alexander Sherman, Gary L. Pattee, Kevin Boylan, Edor Kabashi, Yunxia Wang, Craig Oster, John Ravits, Muddasir Quereshi, Carlayne E. Jackson, Christen Shoesmith, John T. Kissel, Pamela Kittrell, James Heywood, Mieko Ogino, Gleb Levitsky, Bonnie Gerecke, Bjorn Oskarsson, George Sachs, Eric Valor, Kristiana Salmon, Richard Bedlack, Neta Zach, Robin Conwit, Rob Goldstein, Ahmad Ghavanini, Rup Tandan, Fernando G. Vieira, Efrat Carmi, Janice Robertson, Katherine Tindall, James Caress, Megan Grosso, Eric J. Sorenson, Daniel M. Pastula, Michael H. Rivner, Jeffrey D. Rothstein, Stacy A. Rudnicki, Erik P. Pioro, Terry Heiman-Patterson, Dallas Forshew, Lisa Kinsley, Ashok Verma, Paul E. Barkhaus, Ginna Gonzalez, Larry Phillips, Leo McClusky, Jonathan D. Glass, Brett M. Morrison, David Saperstein, Jim Wymer, Jeff Dietz, Catherine Lomen-Hoerth, Tahseen Mozaffar, Gregory T. Carter, Orla Hardiman, Josep Gamez, Vivian E. Drory, Daniel MacGowan, Dan Moore, Colin Quinn, Chafic Karam, Kate Dalton, Tulio E. Bertorini, Nazem Atassi, Robert G. Miller, Peter M Andersen, Robert Bowser, Michael D. Weiss, L. P. Rowland, Michael J. Strong, Jeffrey V. Rosenfeld, Steven Novella, Nicholas J. Maragakis, Michael Benatar, Jeremy M. Shefner, Jon Baker, Jonathan Licht, Kathy Mitchell, Christina Fournier, Mark Bromberg, Mazen M. Dimachkie, Steven Nash, James A. Russell, Paul Wicks, Meraida Polak, Melanie Leitner, Lorne Zinman, Steve Kolb, Noah Lechtzin, Sith Sathornsumetee, Lyle Ostrow, Todd Levine, Jonathan Goldstein, Khema Sharma, Carmel Armon, Laurie Gutmann, and Steve Perrin

Subjects
0301 basic medicine, Compassionate Use Trials, Pathology, medicine.medical_specialty, Drug Evaluation, Preclinical, Pilot Projects, Drug Costs, 03 medical and health sciences, Mice, Mice, Neurologic Mutants, 0302 clinical medicine, Double-Blind Method, Medicine, Animals, Humans, Nerve Growth Factors, Amyotrophic lateral sclerosis, Randomized Controlled Trials as Topic, business.industry, Amyotrophic Lateral Sclerosis, medicine.disease, Peptide Fragments, Rats, Disease Models, Animal, 030104 developmental biology, Treatment Outcome, Neurology, Neurology (clinical), business, Oligopeptides, 030217 neurology & neurosurgery
Published
2016

16. ALSUntangled No. 16: Cannabis

Author

Daniel M. Pastula, Jim Wymer, Michael H. Rivner, Mazen M. Dimachkie, James A. Russell, Steve Kolb, Gary L. Pattee, Muddasir Quereshi, Kathy Mitchell, Noah Lechtzin, Pamela Kittrell, Leo McClusky, Larry Phillips, Melanie Leitner, Hubert Kwieciński, Nicholas Marigakis, Dan Moore, Robert Bowser, Janice Robertson, Yunxia Wang, Carlayne E. Jackson, Todd Levine, James Heywood, Steven Nash, Steven Novella, Carmel Armon, Tahseen Mozaffar, Eric J. Sorenson, Catherine Lomen-Hoerth, Tulio E. Bertorini, Orla Hardiman, Daniel MacGowan, Kate Dalton, Jeremy M. Shefner, Vivian E. Drory, Robert G. Miller, Terry Heiman-Patterson, Dallas Forshew, Megan Grosso, Jonathan Goldstein, John Ravits, Sith Sathornsumetee, George Sachs, Paul Wicks, Jonathan D. Glass, David Saperstein, James Caress, Josep Gamez, Jeffrey D. Rothstein, Hiroshi Mitsumoto, Erik P. Pioro, Jeff Dietz, Michael J. Strong, Lewis P. Rowland, Alexander Sherman, Michael Benatar, Jonathan Licht, Meraida Polak, Michael D. Weiss, Jon Baker, Lisa Kinsley, Katherine Tindall, Stacy A. Rudnicki, Kevin Boylan, Ashok Verma, Robin Conwit, Peter M Andersen, Christen Shoesmith, John T. Kissel, Khema Sharma, Nazem Atassi, Bjorn Oskarsson, Rup Tandan, Richard Bedlack, Ginna Gonzalez, and Bonnie Gerecke

Subjects
medicine.medical_specialty, biology, Cannabinoids, business.industry, Amyotrophic Lateral Sclerosis, Marijuana Smoking, General Medicine, biology.organism_classification, medicine.disease, Neurology, Humans, Immunologic Factors, Medicine, Neurology (clinical), Cannabis, Amyotrophic lateral sclerosis, business, Psychiatry
Published
2012
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17. Longitudinal as well as age-matched assessments of bone changes in the mature ovariectomized rat model

Author

Ae Andrea Tami, Mm Melanie Leitner, Keita Ito, Pierre M. Montavon, University of Zurich, and Orthopaedic Biomechanics

Subjects
musculoskeletal diseases, Pathology, medicine.medical_specialty, 10253 Department of Small Animals, 3400 General Veterinary, Ovariectomy, Osteoporosis, Rat model, In vivo, Internal medicine, Animals, Medicine, Femur, Longitudinal Studies, Rats, Wistar, Quantitative computed tomography, Animal use, Bone mineral, 630 Agriculture, General Veterinary, medicine.diagnostic_test, business.industry, Age Factors, medicine.disease, Rats, Disease Models, Animal, Endocrinology, Ovariectomized rat, 570 Life sciences, biology, Female, Animal Science and Zoology, 1103 Animal Science and Zoology, Tomography, X-Ray Computed, business, Bone volume
Abstract

In the past, bone loss in the ovariectomized (OVX) osteoporotic rat model has been monitored using in vitro micro-computed tomography (micro-CT) to assess bone structure (bone volume/total volume, BV/TV). The purpose of this study was to assess the importance of baseline control and sham groups in 12–16-week-old, reproductively mature rats. Measurements were carried out in a longitudinal and age-matched fashion using newer in vivo peripheral quantitative computed tomography (pQCT), which measures apparent bone mineral density (BMD). BMD was measured at the distal femoral metaphysis of 12-week-old female Wistar rats with pQCT. Subsequently, animals were either OVX or sham operated, and pQCT measurements were repeated four weeks later. Then, all rats were euthanized and in vitro BMD and BV/TV were obtained by micro-CT imaging. Results from three consistently differentiated regions of interest showed that there was significant bone loss and growth during the four weeks in the OVX and sham group, respectively. Taking this into account, i.e. a posteriori superimposing growth to loss, no differences resulted between BMD values measured in a longitudinal fashion with pQCT and that measured in comparison with an age-matched sham group with micro-CT and pQCT. In addition, there was a strong linear correlation between BMD measured with pQCT and BV/TV obtained from micro-CT. In conclusion, this outcome provides new insights into individual bone changes due to OVX and growth in Wistar rats during the age period of 12–16 weeks, which is often applied in osteoporosis research as the ‘mature’ rat model. Data can be used as baseline information upon which future in vivo study designs with this rat model can refer to reduce and minimize animal use.

Published
2009

18. ALSUntangled 15: Coconut Oil

Author

Meraida Polak, Daniel M. Pastula, Michael H. Rivner, James Heywood, James A. Russell, Todd Levine, Orla Hardiman, Steve Kolb, Kevin Boylan, Michael Benatar, Larry Phillips, Michael J. Strong, Steven Novella, Muddasir Quereshi, Vivian E. Drory, Jonathan Goldstein, Ginna Gonzalez, Jonathan Licht, Noah Lechtzin, Kathy Mitchell, Jim Wymer, Melanie Leitner, Pamela Kittrell, Peter M Andersen, Robert G. Miller, George Sachs, Terry Heiman-Patterson, Dallas Forshew, Lisa Kinsley, Paul Wicks, Robert Bowser, Nazem Atassi, Megan Grosso, Tahseen Mozaffar, Lewis P. Rowland, Michael D. Weiss, Hubert Kwieciński, Dan Moore, Alexander Sherman, Janice Robertson, Catherine Lomen-Hoerth, Jon Baker, Eric J. Sorenson, Daniel MacGowan, Kate Dalton, Bonnie Gerecke, Rup Tandan, Gary L. Pattee, James Caress, Katherine Tindall, Leo McClusky, Stacy A. Rudnicki, Carmel Armon, Khema Sharma, Christen Shoesmith, John T. Kissel, Hiroshi Mitsumoto, Ashok Verma, Nicholas Marigakis, Yunxia Wang, Robin Conwit, Carlayne E. Jackson, Jeremy M. Shefner, Bjorn Oskarsson, Richard Bedlack, Mazen M. Dimachkie, Erik P. Pioro, Jeff Dietz, Steven Nash, Jeffrey D. Rothstein, Josep Gamez, John Ravits, Tulio E. Bertorini, Sith Sathornsumetee, Jonathan D. Glass, and David Saperstein

Subjects
food.ingredient, business.industry, Amyotrophic Lateral Sclerosis, Coconut oil, General Medicine, medicine.disease, food, Neurology, Coconut Oil, medicine, Animals, Humans, Plant Oils, Neurology (clinical), Food science, Amyotrophic lateral sclerosis, business
Published
2012
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19. Being PRO-ACTive: What can a clinical trial database reveal about ALS?

Author

Ervin Sinani, David L. Ennist, Jason Walker, Hagit Alon, Alexander V. Sherman, Neta Zach, Igor Katsovskiy, Merit Cudkowicz, Albert A. Taylor, Robert Kueffner, and Melanie Leitner

Subjects
medicine.medical_specialty, Neurology, Databases, Factual, Amyotrophic Lateral Sclerosis, Clinical Trial Database, Clinical Trial Simulation, Disease Progression, Patient Stratification, Disease, Review, computer.software_genre, medicine, Humans, Pharmacology (medical), Clinical care, Amyotrophic lateral sclerosis, Pharmacology, Clinical Trials as Topic, Database, business.industry, Disease progression, medicine.disease, Clinical trial, Natural history, Neurology (clinical), business, computer, Patient stratification
Abstract

Advancing research and clinical care, and conducting successful and cost-effective clinical trials requires characterizing a given patient population. To gather a sufficiently large cohort of patients in rare diseases such as amyotrophic lateral sclerosis (ALS), we developed the Pooled Resource Open-Access ALS Clinical Trials (PRO-ACT) platform. The PRO-ACT database currently consists of >8600 ALS patient records from 17 completed clinical trials, and more trials are being incorporated. The database was launched in an open-access mode in December 2012; since then, >400 researchers from >40 countries have requested the data. This review gives an overview on the research enabled by this resource, through several examples of research already carried out with the goal of improving patient care and understanding the disease. These examples include predicting ALS progression, the simulation of future ALS clinical trials, the verification of previously proposed predictive features, the discovery of novel predictors of ALS progression and survival, the newly identified stratification of patients based on their disease progression profiles, and the development of tools for better clinical trial recruitment and monitoring. Results from these approaches clearly demonstrate the value of large datasets for developing a better understanding of ALS natural history, prognostic factors, patient stratification, and more. The increasing use by the community suggests that further analyses of the PRO-ACT database will continue to reveal more information about this disease that has for so long defied our understanding.

Published
2015

20. The PRO-ACT database: Design, initial analyses, and predictive features

Author

Alexander Sherman, Ervin Sinani, Merit Cudkowicz, Melanie Leitner, Nazem Atassi, Jason Walker, Neta Zach, Igor Katsovskiy, Amy Shui, David A. Schoenfeld, and James D. Berry

Subjects
Research design, medicine.medical_specialty, Pathology, Datasets as Topic, Article, symbols.namesake, chemistry.chemical_compound, Predictive Value of Tests, Internal medicine, medicine, Humans, Longitudinal Studies, Creatinine, Clinical Trials as Topic, business.industry, Proportional hazards model, Amyotrophic Lateral Sclerosis, Clinical trial, Observational Studies as Topic, Bonferroni correction, chemistry, Research Design, Predictive value of tests, symbols, Disease Progression, Database Management Systems, Observational study, Neurology (clinical), business, Body mass index
Abstract

Objective: To pool data from completed amyotrophic lateral sclerosis (ALS) clinical trials and create an open-access resource that enables greater understanding of the phenotype and biology of ALS. Methods: Clinical trials data were pooled from 16 completed phase II/III ALS clinical trials and one observational study. Over 8 million de-identified longitudinally collected data points from over 8,600 individuals with ALS were standardized across trials and merged to create the Pooled Resource Open-Access ALS Clinical Trials (PRO-ACT) database. This database includes demographics, family histories, and longitudinal clinical and laboratory data. Mixed effects models were used to describe the rate of disease progression measured by the Revised ALS Functional Rating Scale (ALSFRS-R) and vital capacity (VC). Cox regression models were used to describe survival data. Implementing Bonferroni correction, the critical p value for 15 different tests was p = 0.003. Results: The ALSFRS-R rate of decline was 1.02 (±2.3) points per month and the VC rate of decline was 2.24% of predicted (±6.9) per month. Higher levels of uric acid at trial entry were predictive of a slower drop in ALSFRS-R ( p = 0.01) and VC ( p p = 0.02). Higher levels of creatinine at baseline were predictive of a slower drop in ALSFRS-R ( p = 0.01) and VC ( p p = 0.01). Finally, higher body mass index (BMI) at baseline was associated with longer survival ( p Conclusion: The PRO-ACT database is the largest publicly available repository of merged ALS clinical trials data. We report that baseline levels of creatinine and uric acid, as well as baseline BMI, are strong predictors of disease progression and survival.

Published
2014

21. ALSUntangled No. 26: lunasin

Author

Jim Wymer, Christina Fournier, Robert Bowser, Lyle Ostrow, Paul E. Barkhaus, Ginna Gonzalez, Hubert Kwieciński, Dan Moore, Muddasir Quereshi, Catherine Lomen-Hoerth, Daniel MacGowan, Pamela Kittrell, Josep Gamez, Eric J. Sorenson, Kate Dalton, Todd Levine, Eric Valor, Ashok Verma, Tulio E. Bertorini, Mark B. Bromberg, Merit Cudkowicz, Noah Lechtzin, Michael J. Strong, Efrat Carmi, Mazen M. Dimachkie, Rup Tandan, Bjorn Oskarsson, Mieko Ogino, Tahseen Mozaffar, James A. Russell, George Sachs, Jonathan Goldstein, Hiroshi Mitsumoto, Steven Novella, Jonathan Licht, Terry Heiman-Patterson, Dallas Forshew, James Heywood, Richard Bedlack, James Caress, Sith Sathornsumetee, Steve Kolb, Kevin Boylan, Nazem Atassi, Yunxia Wang, Carlayne E. Jackson, Paul Wicks, Gary L. Pattee, Meraida Polak, Chafic Karam, Gleb Levitsky, Lorne Zinman, Craig Oster, Carmel Armon, Edor Kabashi, Robin Conwit, John Ravits, Laurie Gutmann, Janice Robertson, Erik P. Pioro, Brett M. Morrison, Orla Hardiman, Leo McClusky, Vivian E. Drory, Jeff Dietz, Colin Quinn, Jonathan D. Glass, Jeremy M. Shefner, Robert G. Miller, David Saperstein, Michael D. Weiss, Jeffrey V. Rosenfeld, Megan Grosso, Jon Baker, Gregory T. Carter, Kathy Mitchell, Melanie Leitner, Michael Benatar, Bonnie Gerecke, Lisa Kinsley, Khema Sharma, Steven Nash, Christen Shoesmith, John T. Kissel, Jeffrey D. Rothstein, Peter M Andersen, Nicholas J. Maragakis, Katherine Tindall, Stacy A. Rudnicki, Daniel M. Pastula, Michael H. Rivner, Larry Phillips, Lewis P. Rowland, and Alexander Sherman

Subjects
Adult, Male, Pathology, medicine.medical_specialty, business.industry, Amyotrophic Lateral Sclerosis, Anti-Inflammatory Agents, Middle Aged, medicine.disease, Neurology, medicine, Soybean Proteins, Humans, Female, Neurology (clinical), Amyotrophic lateral sclerosis, business, Aged, Phytotherapy, Plant Proteins
Published
2014

22. Crowdsourced analysis of clinical trial data to predict amyotrophic lateral sclerosis progression

Author

Johann Hawe, Guang Li, Raquel Norel, Lilly Fang, Lester Mackey, Gustavo Stolovitzky, Melanie Leitner, Rubio Vaughan, Jakob H. Macke, Orla Hardiman, Torsten Hothorn, Robert Küffner, Merit Cudkowicz, Moritz Grosse-Wentrup, Gökhan Ertaylan, Linh Tran, Alexander V. Sherman, Timm Meyer, Liuxia Wang, Neta Zach, Bernhard Schölkopf, David A. Schoenfeld, Jules van Ligtenberg, Sciences, RS: FSE MaCSBio, RS: FPN MaCSBio, Luxembourg Centre for Systems Biomedicine (LCSB): Computational Biology (Del Sol Group) [research center], University of Zurich, and Küffner, Robert

Subjects
medicine.medical_specialty, Biotechnologie [F06] [Sciences du vivant], Biomedical Engineering, MEDLINE, 2204 Biomedical Engineering, 610 Medicine & health, Bioengineering, Disease, Crowdsourcing, Applied Microbiology and Biotechnology, medicine, 2402 Applied Microbiology and Biotechnology, Biotechnology [F06] [Life sciences], Effective treatment, Humans, Amyotrophic lateral sclerosis, Intensive care medicine, Clinical Trials as Topic, 1502 Bioengineering, business.industry, Disease progression, Amyotrophic Lateral Sclerosis, 10060 Epidemiology, Biostatistics and Prevention Institute (EBPI), medicine.disease, Clinical trial, 1313 Molecular Medicine, 1305 Biotechnology, Disease Progression, Molecular Medicine, business, Algorithms, Biotechnology
Abstract

Amyotrophic lateral sclerosis (ALS) is a fatal neurodegenerative disease with substantial heterogeneity in its clinical presentation. This makes diagnosis and effective treatment difficult, so better tools for estimating disease progression are needed. Here, we report results from the DREAM-Phil Bowen ALS Prediction Prize4Life challenge. In this crowdsourcing competition, competitors developed algorithms for the prediction of disease progression of 1,822 ALS patients from standardized, anonymized phase 2/3 clinical trials. The two best algorithms outperformed a method designed by the challenge organizers as well as predictions by ALS clinicians. We estimate that using both winning algorithms in future trial designs could reduce the required number of patients by at least 20%. The DREAM-Phil Bowen ALS Prediction Prize4Life challenge also identified several potential nonstandard predictors of disease progression including uric acid, creatinine and surprisingly, blood pressure, shedding light on ALS pathobiology. This analysis reveals the potential of a crowdsourcing competition that uses clinical trial data for accelerating ALS research and development.

Published
2014

23. Infrastructure resources for clinical research in amyotrophic lateral sclerosis

Author

Jeremy M. Shefner, Robin Conwit, Melanie Leitner, Amelie K. Gubitz, Richard Bedlack, Robert G. Miller, Petra Kaufmann, Hiroshi Mitsumoto, Jean Paul Vonsattel, D. Kevin Horton, Brent T. Harris, Ammar Al-Chalabi, James D. Berry, and Alexander V. Sherman

Subjects
Gerontology, Government, medicine.medical_specialty, Biomedical Research, Databases, Factual, business.industry, Amyotrophic Lateral Sclerosis, Disease, medicine.disease, Clinical trial, Europe, Clinical research, Disease registry, Neurology, Family medicine, Agency (sociology), Patient oriented, North America, medicine, Health Resources, Humans, Neurology (clinical), Amyotrophic lateral sclerosis, business
Abstract

Clinical trial networks, shared clinical databases, and human biospecimen repositories are examples of infrastructure resources aimed at enhancing and expediting clinical and/or patient oriented research to uncover the etiology and pathogenesis of amyotrophic lateral sclerosis (ALS), a rapidly progressive neurodegenerative disease that leads to the paralysis of voluntary muscles. The current status of such infrastructure resources, as well as opportunities and impediments, were discussed at the second Tarrytown ALS meeting held in September 2011. The discussion focused on resources developed and maintained by ALS clinics and centers in North America and Europe, various clinical trial networks, U.S. government federal agencies including the National Institutes of Health (NIH), the Agency for Toxic Substances and Disease Registry (ATSDR) and the Centers for Disease Control and Prevention (CDC), and several voluntary disease organizations that support ALS research activities. Key recommendations included 1) the establishment of shared databases among individual ALS clinics to enhance the coordination of resources and data analyses; 2) the expansion of quality-controlled human biospecimen banks; and 3) the adoption of uniform data standards, such as the recently developed Common Data Elements (CDEs) for ALS clinical research. The value of clinical trial networks such as the Northeast ALS (NEALS) Consortium and the Western ALS (WALS) Consortium was recognized, and strategies to further enhance and complement these networks and their research resources were discussed.

Published
2013

24. Platform for Clinical Trials Data Integration and Sharing as a Unique Industry, Academic, and Foundation Collaboration Resource in ALS Research (P01.091)

Author

Merit Cudkowicz, Igor Katsovskiy, Melanie Leitner, Ervin Sinani, and Alexander Sherman

Subjects
Clinical trial, Engineering, Resource (project management), Knowledge management, business.industry, Foundation (evidence), Neurology (clinical), computer.software_genre, business, computer, Data integration
Published
2012
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