Aug27
Does CYP2D6 Impact Ondansetron Response in Early Pregnancy Induced Nausea and Vomiting?
Nausea and vomiting in pregnancy (NVP), colloquially known as morning sickness, impacts 8 in 10 pregnancies. When symptoms are severe, patients are often prescribed ondansetron, an anti-nausea medication. Previous studies, in non-pregnant persons, suggest variable response to ondansetron based on ...
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Aug11
Words Matter: Standardizing Clonal Hematopoiesis Terminology
Despite growing recognition of clonal hematopoiesis as a confounder in liquid biopsy, the terminology used to describe its biology and clinical implications remains inconsistent. Closely related terms, such as CH, clonal hematopoiesis of indeterminate potential (CHIP), and age-related clonal hemato...
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Jul21
Model-Informed Dosing for DNDI-6148 in Cutaneous Leishmaniasis
For the neglected tropical skin infection cutaneous leishmaniasis, there is only one approved oral treatment, which is limited by safety and efficacy concerns, underscoring the urgent need for better oral therapies. Drugs for Neglected Diseases initiative (DNDi) has identified DNDI-6148 as a precli...
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Jul09
Can We Train Clinical Trial Teams to Shrink the Placebo Effect? The PINgPOng Study Has Answers
For decades, researchers have sought ways to control the placebo effect, mostly by educating patients about placebo mechanisms. But what about the study team itself? After all, in early-phase inpatient trials, clinicians, nurses, and coordinators spend days in close, repeated contact with parti...
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Jun30
A Prospective Phase 1 Study of Nirmatrelvir/Ritonavir in Healthy Lactating Women
Pregnant or lactating women with COVID-19 are at increased risk of developing severe disease or complications, such as hypertension, preeclampsia, or a need for intensive care admission. 1,2 However, because of perceived safety concerns regarding infant exposure, breastfeeding women were excluded ...
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Jun11
Summary of "Hypoxia Promotes an Adrenergic to Mesenchymal Transcriptional Program Transition in Neuroblastoma"
Neuroblastoma, the deadliest solid childhood cancer outside the brain, is thought to contain two cell states: aggressive, stem-like mesenchymal cells and committed, neuron-like adrenergic cells. Adrenergic cells comprise the bulk of tumors and are generally more sensitive to traditional therapy, wh...
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May22
IDERHA Initiative Seeks to Accelerate Policy Development
Real-world data (RWD) and real-world evidence (RWE) have the potential to transform how we study the safety, effectiveness, and value of medicines and medical technologies. As researchers, we have opportunities to generate insights from routine clinical care that can complement clinical trials and ...
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May12
Treat Patients Faster: Surrogate Endpoint Use in Drug Approvals
In the recent Clinical and Translational Science perspective piece authored by Drs. Linda Jeng and Jeffrey Siegel, they illuminate a critical pathway for bringing treatments to patients faster: the use of surrogate endpoints in drug approval decisions. The authors conclude that when rigorously ...
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Apr23
Understanding Patient Perspectives: Bridging the Gap for Pharmacogenetics Implementation in Gastrointestinal Oncology
Pharmacogenetics (PGx) is a form of precision medicine that applies knowledge of drug-gene interactions to maximize effectiveness and reduce toxicity of medications. Given the elevated risk of severe, and sometimes life-threating, chemotherapy-associated toxicities in genetically susceptible pati...
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Apr03
New Horizon in Ulcerative Colitis Treatment? Targeted Inhibition of IL 6 Trans Signaling May Improve Outcomes
Interleukin‑6 (IL‑6) plays a central role in ulcerative colitis (UC) by activating two distinct pathways: classic signaling, mediated by the membrane‑bound IL‑6 receptor and supporting homeostasis and tissue repair, and trans‑signaling, mediated by the soluble IL‑6 receptor and driving pro‑inflamm...
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