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Velasco Thibault
Diuresis to achieve decongestion is a central aim of therapy in patients hospitalized for acute decompensated heart failure (ADHF). While multiple clinical trials have investigated initial diuretic strategies for a designated period of time, there is a paucity of evidence to guide diuretic titration strategies continued until decongestion is achieved. The use of urine chemistries (urine sodium and creatinine) in a natriuretic response prediction equation accurately estimates natriuresis in response to diuretic dosing, but a randomized clinical trial is needed to compare a urine chemistry-guided diuresis strategy with a strategy of usual care. The urinE chemiStry guided aCute heArt faiLure treATmEnt (ESCALATE) trial is designed to test the hypothesis that protocolized diuretic therapy guided by spot urine chemistry through completion of intravenous diuresis will be superior to usual care and improve outcomes over the 14 days following randomization. ESCALATE will randomize and obtain complete data on 450 patients with acute heart failure to a diuretic strategy guided by urine chemistry or a usual care strategy. Key inclusion criteria include an objective measure of hypervolemia with at least 10 pounds of estimated excess volume, and key exclusion criteria include significant valvular stenosis, hypotension, and a chronic need for dialysis. Our primary outcome is days of benefit over the 14 days after randomization. Days of benefit combines patient symptoms captured by global clinical status with clinical state quantifying the need for hospitalization and intravenous diuresis. CLINICAL TRIAL REGISTRATION: NCT04481919.
Through this Notice of Funding Opportunity (NOFO), the National Cancer Institute (NCI) intends to create multidisciplinary research groups or partnerships for the discovery of pharmacological agents to treat fusion oncoprotein-driven childhood cancers. This NOFO will use the UM1 mechanism to fund Next Generation Chemistry (NGC) Centers with interdisciplinary teams focusing on innovative medicinal chemistry, chemical biology and chemoproteomic approaches to target fusion oncoprotein-driven cancers. The goal of this program is to accelerate innovative drug discovery focused on developing small molecules to effectively disrupt fusion oncoproteins through mechanisms including, but not limited to, inhibiting activities of fusion oncoproteins, blocking critical fusion oncoprotein interactions, modulating coding and/or noncoding RNAs required for fusion protein oncogenesis, and selectively degrading fusion proteins and/or proteins representing critical fusion oncoprotein dependencies. The NCI encourages applications to advance the discovery, preclinical development, and proof of concept testing of new, rationally designed candidate agents to treat fusion-derived childhood cancers. Funding priority will be given to applications that focus on fusion oncoproteins found in tumors that have high risk of treatment failure and for which there has been little progress in identifying targeted therapeutic agents. Applications focused on pediatric solid tumors and brain tumors are particularly encouraged. Small molecules are defined here as chemically synthesized drug-like compounds with molecular weights
To properly address the NOFO goals, each proposed NGC Center will be expected to include diverse areas of expertise to facilitate progression from structure-function biochemical data to small molecule drug candidates and setting the stage for preclinical in vivo testing. Relevant areas of expertise that could be included are (among others) chemoproteomics, structural biology, molecular biology, medicinal chemistry, and experimental therapeutics. Multi-institutional collaborations are strongly encouraged to achieve the breadth of expertise required for a comprehensive approach to developing effective therapeutic agents for fusion oncoprotein-derived pediatric cancers. An NGC Center can focus on one or more potential target(s), as appropriate for the proposed scope and budget.
In line with the interdisciplinary collaborative nature of this initiative, it may be appropriate to have at least one PD/PI with medicinal chemistry and at least one with biologically active small molecules evaluation and drug development expertise.
Background: The FDA has recently proposed pre-marketing liver chemistry subject stopping criteria. The study was undertaken to determine the background rates of liver chemistry abnormalities in clinical trial populations without underlying liver disease.
Methods: Data from 28 Phase II-IV trials in diseases with normal risk of underlying liver abnormalities were included. Information on 18,672 subjects, mean age of 44.3 years and 92.3% female was available. Prevalence and incidence of abnormal liver chemistries were calculated.
Conclusion: Elevations of ALT (3 x ULN) and ALP (2 x ULN) are rare in clinical trial populations without underlying liver disease and can be considered a safety signal. No events of ALT 3 x ULN with concomitant bilirubin 1.5 x ULN were noted. These analyses create a liver chemistry evidence base in normal risk clinical trial populations.
Max Royzen, an associate professor of chemistry, partnered with San Francisco-based biotech firm Shasqi, to develop an anticancer therapy that utilizes bio-orthogonal click chemistry to target a powerful drug at cancerous tumors. Bio-orthogonal click chemistry is a process by which two highly reactive and selective for each other compounds react inside a live organism and according to Royzen, this makes it incredibly valuable in medical chemistry and in particular cancer treatment because it can target the cancerous cells while sparing healthy cells.
In the clinical trials, a patient is first given an injection of the sodium hyaluronate biopolymer. Patients then receive five daily infusions of doxorubicin with the TCO unit, which circulates the drug through the body until it finds the sodium hyaluronate biopolymer and a click reaction occurs to bring the biopolymer and doxorubicin together. This reaction triggers the doxorubicin to touch only the tumor cells while leaving the healthy surrounding cells intact.
Catrin Brown teaches IB Chemistry and Biology at Lester Pearson United World College of the Pacific in Canada. Having taught international curricula since 1992, she has been involved in almost all aspects of IB curriculum and assessment, including International A level moderation, leading teacher workshops and co-writing the current chemistry curriculum.
Oliver Canning teaches IB Chemistry and is the TOK Coordinator at TASIS England. In addition to nine years working in the IB Diploma programme, he has taught chemistry courses in English, American, and Spanish education systems. He is also a Course Leader for the educational charity Amala, which works with displaced youth. He was a contributing author to the upcoming chemistry curriculum as well as developing the accompanying Teacher Support Materials.
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Andrew Nortcliffe, Assistant Professor of Medicinal Chemistry at the University of Nottingham is supervising the students using the new system, he said: Data led approaches to chemical research are starting to become more prevalent in industry, turning to digital solutions to increase accuracy, efficiency and reproducibility of chemical reactions. But in the chemistry teaching lab there remains a disparity between practical work and how capturing data can refine and improve outcomes."
Ranked 32 in Europe and 16th in the UK by the QS World University Rankings: Europe 2024, the University of Nottingham is a founding member of the Russell Group of research-intensive universities. Studying at the University of Nottingham is a life-changing experience, and we pride ourselves on unlocking the potential of our students. We have a pioneering spirit, expressed in the vision of our founder Sir Jesse Boot, which has seen us lead the way in establishing campuses in China and Malaysia - part of a globally connected network of education, research and industrial engagement.
Potential clinical trial participants and sponsors typically wait 2-3 days for lab results to determine eligibility. For the would-be participant every day that elapses could contribute to the loss of interest and increase the risk of losing a potential study subject for many reasons. And for the pharmaceutical sponsor, delays in enrollment increase the costs of the study and impact the future revenues from commercialization. Sponsors are well aware that the availability of lab test results can make a difference in the completion of key milestones in a clinical trial project. The shipping process of blood samples for a standard battery of chemistry tests represents the most significant cause of the delay as most laboratories can complete a battery on the day they receive the sample. In addition to the time lag, shipping lab samples in test tubes typically adds 25-35% of the total cost of central lab testing. In short, shipping blood samples for enrollment is not only slow, it can be very expensive.
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