Point of Care Lung Ultrasound in Preterm Infants With Respiratory Distress: A Multicenter Prospective Study
The goal of this observational study is to learn about the role of bedside lung ultrasound in infants born prematurely with breathing problems. The main question this study aims to answer is: Can bedside lung ultrasound performed in the first month of life predict the development of chronic lung disease in premature infants?
An Open Label Study to Assess the Safety and Clinical Efficacy of MBM-02 to Increase Survival in Patients With Newly Diagnosed Glioblastoma Multiforme (GBM)
MBM-02 (Tempol) is an HIF-1 and HIF-2 inhibitor that is being tested as an addition to standard of care treatment that includes radiotherapy and TMZ. MBM-02's ability to increase progression free survival and decrease side effects of TMZ and radiotherapy treatment will be assessed.
Association Between Angiotensin Converting Enzyme Inhibitor or Angiotensin Receptor Blocker Use and COVID-19 Severity and Mortality Among US Veterans
Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), the virus responsible for COVID-19, enters type II pneumocytes using angiotensin-converting enzyme 2 (ACE2). It is unclear whether ACE inhibitors (ACEIs) and angiotensin receptor blockers (ARBs) increase, decrease, or have no significant effect on ACE2 expression or activity. Therefore, ACEI and ARB may be harmful, beneficial, or have no impact on Coronavirus Disease 2019 severity and mortality. The Specific Aims of this observational study are: (1) Among SARS-CoV-2-positive outpatients, compare all-cause hospitalization and mortality rates between: 1.1 Current users of a range of doses of ACEI/ARB- vs. non- ACEI/ARB-based regimens, and 1.2 Current users of a range of doses of ACEI- vs. ARB-based regimens, and (2) Among those hospitalized for COVID-19, compare all-cause mortality between: 2.1 Current users of a range of doses of ACEI/ARB- vs. non- ACEI/ARB-based regimens, and 2.2 Current users of a range of doses of ACEI- vs. ARB-based regimens.
Fecal pancreatic elastase-1 in the evaluation of pancreatic function after pediatric intestinal transplantation
4区 · 医学
作者: Kaufman, Stuart S. ; Zhong, Xiaogang Simon ; Elsabbagh, Ahmed M. ; Bailey, Dominique ; Yazigi, Nada A. ; Khan, Khalid M. ; Matsumoto, Cal S.
Fat malabsorption is common after SBT. To identify whether anatomic variant transplants differ in occurrence of exocrine pancreatic insufficiency that could contribute to fat malabsorption, we measured FPE repeatedly in 54 recipients of a SBT, ages 6.2 to 320 months. FPE determination most distant from SBT was 6.1 years. Of the 54, 39% received an isolated intestinal graft (native pancreas only), 48% received an en bloc liver-intestinal-pancreas graft (native and graft pancreas), and 13% received a multivisceral graft (graft pancreas only). Initial FPE was normal (>200 μg/g) in 15 of the 54 at a median of 22 (11-61) days after SBT. Recipients of a liver-intestine-pancreas transplant were more likely to have normal FPE within 30 days after SBT than were isolated intestinal or multivisceral transplant recipients (47%, 19%, and 0%, respectively, P = .049). Of the remaining 39 patients, 34 eventually demonstrated a normal FPE at a median of 168 (31-943) days after SBT. Type of SBT did not influence the likelihood of achieving a normal FPE level or time when it occurred. Five (9%) patients failed to achieve normal FPE, including 3 who died within 2 years after SBT. In conclusion, possessing both graft and native pancreas as in transplantation of an en bloc liver-intestinal-pancreas graft facilitates early normalization of FPE that eventually occurs in most patients irrespective of transplant type. Failure to recover normal pancreatic function may be associated with severe post-transplant complications.
2018-01-09·Current Pharmaceutical Design4区 · 医学
Is Statin Therapy Safe and Effective in Patients with Chronic Kidney Disease?
4区 · 医学
作者: Raman, Venkatesh K. ; Geladari, Eleni ; Papademetriou, Vasilios
Chronic kidney disease (CKD) is associated with dyslipidemia and increased cardiovascular risk. This elevated risk for cardiovascular events exists even in the largest subpopulation with milder stages of CKD, prior to the development of significant reductions in renal excretory function. Statin therapy is a critical component of primary and secondary cardiovascular prevention efforts for at-risk patients. Efficacy in the CKD population, however, has appeared less robust across the spectrum of CKD, particularly in hemodialysis patients. This article will review the current state of knowledge on statin therapy in CKD, effects on renal outcomes, safety in this population and alternative lipid therapies.
2018·Expert Review of Hematology
Determining the sequence of novel therapies in the treatment of relapsed Hodgkin's lymphoma
作者: Narkhede, Mayur ; Yazdy, Maryam S. ; Cheson, Bruce
A review. Introduction: Hodgkin's lymphoma (HL) accounts for about 10% of all lymphomas in the USA. Exceptional progress has been made in the treatment of HL with complete response (CR) rates up to 94% in limited stage and 88% in advanced stage disease with regimens such as adriamycin, bleomycin, vinblastine, and dacarbazine in the frontline setting. Nevertheless, up to 10% of patients with limited stage disease and 20-30% of those with advanced stage HL relapse. In the last decade, newer agents such as brentuximab vedotin (BV) and checkpoint inhibitors have been approved by the FDA for treatment of patients with relapsed or refractory HL. As these newer agents are increasingly incorporated in both the frontline and relapsed settings, their optimal sequence becomes challenging for clinicians. Areas covered: This review will discuss the evidence behind the approval of BV and checkpoint inhibitors in HL and the appropriate sequence for using them in relapsed HL. Expert commentary:The appropriate sequence of BV and/or checkpoint inhibitors in the relapsed setting depends on the regimen used in the frontline setting.
Gift represents the latest milestone in a long history of philanthropic investments focused on community health.
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WASHINGTON, Sept. 26, 2023 /PRNewswire/ -- Monumental Sports & Entertainment, owner of the Washington Capitals, Wizards, Mystics, Capital One Arena, and Monumental Sports Network, among other sports and entertainment investments, has reaffirmed its commitment to the well-being of Washington, D.C. residents by contributing $1 million to D.C. Safe Babies Safe Moms, a collaborative initiative with MedStar Health that aims to bolster maternal and infant health in the nation's capital.
D.C. Safe Babies Safe Moms is a groundbreaking partnership uniting MedStar Health, Community of Hope, and Mamatoto Village to address critical maternal and infant care disparities in Washington, D.C., which has among the highest rates of maternal and infant mortality in the nation. This program offers a comprehensive array of services to support birthing individuals before, during, and after pregnancy and until their child reaches age three. This includes on-site mental health support during prenatal and postpartum visits, assessments for high-risk or complicated pregnancies, social support services for mothers and families who may be experiencing food or housing insecurity, pro-bono legal services, and other counseling on securing public benefits, transportation to and from appointments, infant care supplies, culturally-aware breastfeeding support, and more.
"We're honored to make this substantial contribution on behalf of Monumental Sports to benefit infants and mothers here in Washington, D.C.," said Monica Dixon, president, external affairs and chief administrative officer. "We recognize the pressing need to improve health outcomes for families and babies residing in historically under-resourced areas of the District and we're proud to make this investment in our community. We also want to thank the fans who champion our teams, visit our venues, or consume media across our network and platforms for their support in this work."
Monumental Sports' generous gift will underpin essential components of the D.C. Safe Babies Safe Moms program including vital clinical and research personnel and programmatic needs.
"We're thrilled to have Monumental Sports join us in this important mission to help the most vulnerable members of our community," said Steve Evans, MD, executive vice president for Medical Affairs and chief medical officer for MedStar Health. "There is nothing more significant than affording mothers, babies, and families with a solid, healthy foundation and the best opportunity to thrive. This gift will help the initiative continue its valuable, life-changing work."
The creation of D.C. Safe Babies Safe Moms became possible through a transformational investment from the A. James & Alice B. Clark Foundation, which established the program in 2020. It brought together nationally recognized experts and care in the fields of women's health, family medicine, behavioral health, and pediatrics across MedStar Washington Hospital Center and MedStar Georgetown University Hospital and strengthened ties to the community through partnerships with long-trusted organizations Community of Hope and Mamatoto Village.
"Safe Babies Safe Moms is making a substantial difference for new parents in underserved areas of the District," said Tamika Auguste, MD, regional chair, Obstetrics and Gynecology in the Washington, D.C. region. "Our primary focus is delivering services to a culturally diverse set of patients, alongside culturally competent and appropriate care, aimed at enhancing the health and well-being of mothers and their babies now and for years to come."
Monumental Sports' philanthropic investment in the D.C. Safe Babies Safe Moms program continues a years-long partnership with MedStar Health to improve the lives of people in the community through a $10 million, multi-year commitment. In 2022 Monumental supported MedStar Health's Center for Wellbeing; in both 2020 and 2021 Monumental helped with increasing needs around COVID-19 response and vaccination efforts and in 2019 helped to enhance the sports medicine program at MedStar Health's Lafayette Centre, where patients receive outpatient surgery, physical therapy, and rehabilitation.
"Monumental Sports has made tremendous contributions to the health of our community over the years through their continuous support of the people we serve," said Dr. Evans. "We are sincerely grateful for their ongoing commitment to help us fulfill our mission to our associates, patients, and their families."
For more information about MedStar Health's work to improve maternal and infant health in Washington, D.C., visit MedStarHealth.org/SafeBabiesSafeMoms.
Learn more about our partnership with Monumental Sports.
SOURCE MedStar Health
In-person event and virtual webcast to be held on Sunday, October 22, 2023 at 8:00pm CEST / 2:00pm ETSAN DIEGO, Sept. 26, 2023 (GLOBE NEWSWIRE) -- Ambrx Biopharma Inc., Ambrx (or the “Company”) (NASDAQ: AMAM), today announced that it will host an in-person key opinion leader (KOL) event during the European Society for Medical Oncology (ESMO) Congress 2023. The event will take place on Sunday, October 22, 2023 from 8:00pm – 10:00pm CEST (2:00pm – 4:00pm ET) at the Santo Mauro Hotel in Madrid, Spain. Discussions will feature preliminary safety, efficacy, and pharmacokinetic (PK) data from APEX-01 (NCT04662580), a first-in-human study evaluating ARX517 in prostate cancer patients, which will be presented for the first time at ESMO 2023. The event will showcase presentations from prostate cancer experts, Scott T. Tagawa, MD, MS, FACP, FASCO (Weill Cornell Medicine), Oliver Sartor, MD (Mayo Clinic), John Shen, MD (UCLA Health), and pharmacokinetics expert Rakesh Dixit, PhD, DABT (Regis Biosciences; BIONAVIGEN Oncology). To register for the event, please click here. For those who are unable to attend in person, a virtual webcast of the event will be available at the same link. A replay of the event will be available on the Investor Relations section of the Ambrx website (www.ambrx.com) after the event. Corresponding presentation materials will also be available for download at the Company's website following the event. About Scott T. Tagawa, MD, MS, FACP Dr. Tagawa, an investigator in Ambrx’s APEX-01 trial, is a Professor of Medicine and Professor of Medicine in Urology at Weill Cornell Medicine, and an Attending Physician at New York-Presbyterian – Weill Cornell Medical Center. After earning his BS from Georgetown University, Dr. Tagawa received his MD at the University of Southern California School of Medicine. In 2005, he was appointed Assistant Professor of Medicine at Mount Sinai School of Medicine and served as Director of Genitourinary Oncology for the Division of Hematology and Oncology and Director of Medical Oncology for the Deane Prostate Health and Research Center. He is currently the Medical Director of the Genitourinary Oncology Research Program at Weill Cornell Medical College where he leads clinical trials in the areas of prostate, bladder, and kidney cancer as well as the prevention and treatment of thrombosis with cancer. Dr. Tagawa also serves as co-Leader of the Experimental Therapeutics Program and Leader of the GU Disease Management Team of the Meyer Cancer Center. About Oliver Sartor, MD Professor Oliver Sartor is a medical oncologist and translational researcher with a special focus on prostate cancer over the past 33 years. He completed his fellowship in Medical Oncology in 1989 at the National Cancer Institute, Bethesda and is currently Director of Radiopharmaceutical Clinical Trials at Mayo Clinic in Rochester, Minnesota. He has published over 500 peer-reviewed articles, led or co-led multiple national and international clinical studies, including four phase III studies pivotal for FDA approval (Quadramet, Xofigo, Pluvicto, and Jevtana). He has served as the past Chairman of the Department of Defense Prostate Cancer Integration Panel, is past Editor-in-Chief of the peer-reviewed journal Clinical Genitourinary Cancer, and is the Medical Oncology Chair of the GU committee of NRG, a national cancer research group. About John Shen, MD Dr. Shen, an investigator in Ambrx’s APEX-01 trial, is a medical oncologist who practices in Westwood, Santa Monica and Encino. He is board certified in internal medicine and medical oncology, and he specializes in the care of older adults with advanced cancers. His research interests include genitourinary malignancies, such as cancers of the prostate, kidney, and bladder, as well as improving access to clinical trials for older adults. Dr. Shen received his medical degree from the University of California, Irvine. He then completed his internal medicine residency at Cedars-Sinai Medical Center, and his combined fellowship in hematology/oncology and geriatric medicine at UCLA. He received his Bachelor of Science degree from Stanford University, with honors in cancer biology. Dr. Shen is a member of the American Society of Clinical Oncology and the International Society of Geriatric Oncology. About Rakesh Dixit, Ph.D., DABT Dr. Dixit is an accomplished executive, inventor, and scientist with over 35 years of success with top biotechnology and pharmaceutical companies, including Merck, Johnson & Johnson, MedImmune & AstraZeneca. He is President and CSO of Regio Biosciences and Bionavigen, LLC. He is a Board Member of Regio Biosciences and a key member of multiple scientific advisory boards of ADC companies. Dr. Dixit is also a chief adviser and consultant for over 20 companies worldwide. From 2006 to 2019, Dr. Dixit was a Global Vice President of the Biologics R&D at MedImmune - AstraZeneca. He has unique expertise in developing biologics (e.g., monoclonal antibodies, bispecific biologics, antibody-drug conjugates, fusion proteins, peptides, gene and cell therapies, etc.) and small-molecule biopharmaceuticals. Dr. Dixit conducted extensive graduate and post-graduate training in Pharmacology/Toxicology–Biochemistry with both Indian and USA Institutions (e.g., Case Western Reserve University, Medical College of Ohio, University of Nebraska) and is a Diplomate and Board Certified in Toxicology from the American Board of Toxicology, Inc. since 1992. About Ambrx Biopharma Inc. Ambrx is a clinical stage biopharmaceutical company using an expanded genetic code technology platform to discover and develop next generation antibody drug conjugates (ADCs) and other engineered therapies to modulate the immune system. Ambrx is advancing a focused portfolio of clinical and preclinical programs designed to optimize efficacy and safety in multiple cancer indications, including ARX517, its proprietary antibody-drug conjugate (ADC) targeting the prostate-specific membrane antigen (PSMA) and ARX788, its proprietary ADC targeting HER2. In addition, Ambrx has preclinical and clinical collaborations with multiple partners on drug candidates generated using Ambrx technology. Ambrx spun out of The Scripps Research Institute in 2003 and has several other product candidates involving ADCs and other aspects of Ambrx’s protein engineering technology. For more information, please visit www.ambrx.com. Ambrx routinely posts information that may be important to investors on its website. Forward-Looking Statements This press release includes certain “forward-looking statements” intended to qualify for the “safe harbor” from liability established by the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements may be identified by the words “intend,” “plan,” and similar expressions. Forward-looking statements are based on Ambrx’s current expectations and are subject to inherent uncertainties, risks and assumptions that are difficult to predict. Factors that could cause actual results to differ include, but are not limited to, those risks and uncertainties associated with: Ambrx’s ability to execute on its strategy including with respect to the timing of its R&D efforts, initiation of clinical trials and other anticipated milestones; risks associated with development and marketing approval of novel therapeutics, including potential delays in clinical trials and regulatory submissions and the fact that future clinical trial results/data may not be consistent with interim, initial or preliminary results/data or results/data from prior preclinical studies or clinical trials; Ambrx’s ability to fund operations as anticipated; and the additional risks and uncertainties set forth more fully under the caption “Risk Factors” in Ambrx’s Quarterly Report on Form 10-Q filed with the SEC on August 9, 2023, and elsewhere in Ambrx’s filings and reports with the SEC, including the prospectus supplement to be filed in connection with the Offering. Forward-looking statements contained in this press release are made as of this date, and Ambrx undertakes no duty to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as may be required under applicable law. Contacts INVESTORSMike MoyerLifeSci Advisors617firstname.lastname@example.org MEDIAKarissa CrossLifeSci Communications615-651-4622 email@example.com Source: Ambrx Biopharma, Inc.
Additions bring diversity of medical experience for wider range of clinical trials
DURHAM, N.C., Sept. 21, 2023 /PRNewswire/ -- Clinical research organization EmVenio Research recently announced the addition of Michelle Mallitz, M.D. and Thomas Wade, M.D. to its team to serve as principal investigators. In their roles, they will oversee and conduct objective clinical research to ensure independent, high quality and reproducible results, as well as manage oversight of compliance, financial, personnel and other related aspects of research projects. Coming from varying medical backgrounds, Drs. Mallitz and Wade bring a depth of knowledge and experience to the EmVenio team, allowing the research organization to conduct trials addressing a wider range of infectious diseases and therapeutic areas.
EmVenio appointed Drs. Michelle Mallitz and Thomas Wade as principal investigators to manage clinical research processes
Michelle Mallitz, M.D. (left) and Thomas Wade, M.D. join EmVenio Research as principal investigators.
"The addition of these two incredible principal investigators is proof that EmVenio's growth is focused on quality and not quantity," said Thad Wolfram, EmVenio president. "These individuals bring a level of expertise and skill that opens more doors for our team to conduct a multitude of research studies for pharmaceutical sponsors and clinical research organizations. With their added expertise, we can expand our range of studies, from immunizations against the latest infectious disease mutations to long-term treatments for diabetes and cardiovascular disease."
Collectively, Drs. Mallitz and Wade participated in nearly 300 clinical trials, serving in all phases.
Dr. Michelle Mallitz has 23 years of experience in the medical field with 10 of those years spent serving as an internal investigator for various research facilities. She was most recently a clinical investigator at Care Access. She has worked on 130 clinical trials in various areas of study focusing mainly on cardiovascular effects.
Dr. Mallitz holds a Bachelor of Science in molecular biology from the University of Wisconsin, a Master of Science in human physiology from Georgetown University and a doctorate from Georgetown University School of Medicine. She has held an American Board of Internal Medicine certification for the past 23 years and is currently licensed to practice in the state of Florida.
Dr. Thomas Wade holds nearly 23 years of medical practice and clinical research experience, serving as a principal investigator and practicing internal medicine. As a principal investigator, he participated in more than 75 clinical trials, including studies for treatments for chronic illnesses and rare genetic conditions.
Dr. Wade holds a post-baccalaureate degree in pre-medical studies from Indiana University and a Medical Doctorate from Indiana University School of Medicine. He is a member of multiple advisory committees and councils and the chair of the Human Research Protection Program as part of the Association for the Accreditation of Human Research Protection Programs. He holds certifications with CITI Good Clinical Practice, the National Board of Physicians and Surgeons and the American Board of Internal Medicine. Dr. Wade is also medically licensed in 12 states.
About EmVenio Research
EmVenio Research provides rapid and scalable mobile community research site solutions to better reach and recruit diverse, underserved, high-risk communities. EmVenio Research's global network of skilled clinicians, principal investigators and state-of-the-art mobile community research sites enable us to provide robust clinical research services via home visits, on-site support at medical facilities, virtual visits and mobile sites. Visit emvenio.com to learn more.