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| http://dx.doi.org/10.1136/qshc.2005.016816 | DOI Listing |
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Representation of women in clinical trials supporting FDA-approval of contemporary cancer therapies.
Int J Cancer
December 2024
Cardio-Oncology Program, Division of Cardiology, The Ohio State University Medical Center, Columbus, Ohio, USA.
Article Synopsis
- - The study examined gender representation in clinical trials for FDA-approved anticancer drugs from 1998-2018, focusing on participation rates of women compared to men across various cancer types.
- - Findings indicated that women constituted only 40.7% of participants in 148 trials, with significant under-representation in trials for gastric, liver, and lung cancers, while sex-specific efficacy and safety data were rarely reported (only 4% of trials).
- - Despite low female enrollment, there was no correlation between the percentage of women recruited and drug efficacy, highlighting a persistent gap in gender representation in cancer research.
Isoquercetin for thromboinflammation in sickle cell disease: a randomized double-blind placebo-controlled trial.
Blood Adv
January 2024
Sickle Thrombosis and Vascular Biology Lab, Sickle Cell Branch, National Heart Lung and Blood Institute, National Institutes of Health, Bethesda, MD.
Data from a small trial in patients with cancer suggest that isoquercetin (IQ) treatment lowered thrombosis biomarkers and prevented clinical thrombosis, but, to our knowledge, no studies of IQ have been conducted to target thromboinflammation in adults with sickle cell disease (SCD). We conducted a randomized, double-blind, placebo-controlled trial in adults with steady-state SCD (hemoglobin SS [HbSS], HbSβ0thal, HbSβ+thal, or HbSC). The primary outcome was the change in plasma soluble P-selectin (sP-selectin) after treatment compared with baseline, analyzed in the intention-to-treat population.
View Article and Find Full Text PDFRituximab as maintenance therapy for ANCA-associated vasculitides: pooled analysis and long-term outcome of 277 patients included in the MAINRITSAN trials.
Ann Rheum Dis
January 2024
Department of Internal Medicine, National Reference Center for Rare Systemic Autoimmune Diseases, AP-HP.Centre, Hospital Cochin, Paris, France
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- - The study aimed to compare how effective and safe different treatment schedules with azathioprine (AZA) and rituximab (RTX) are in preventing relapses in patients with ANCA-associated vasculitis who are in complete remission.
- - Researchers conducted trials that compared 18-month fixed RTX to AZA, 18-month fixed RTX to 18-month tailored RTX, and extended 36-month RTX therapy versus placebo, tracking patient outcomes over 84 months.
- - Findings indicated that the 18-month fixed RTX regimen was significantly better at preventing major relapses compared to AZA and the tailored RTX approach, leading to a higher remission rate at the 84-month mark.
Incident Atrial Fibrillation and Survival Outcomes in Esophageal Cancer following Radiotherapy.
Int J Radiat Oncol Biol Phys
January 2024
Cardio-Oncology Program, Division of Cardiology, The Ohio State University Medical Center, Columbus, Ohio; Division of Cancer Prevention and Control, Department of Internal Medicine, College of Medicine, The Ohio State University, Columbus, Ohio. Electronic address:
Article Synopsis
- Radiation therapy (RT) for esophageal cancer was linked to a high incidence of atrial fibrillation (AF) and major adverse cardiovascular events (MACE), with 21.4% of patients developing AF soon after treatment.
- Most cardiovascular events occurred within two years post-RT, showing a significantly higher observed AF rate compared to predicted rates from the Framingham study.
- Increased radiation dose to the left atrium was strongly associated with the development of AF and negatively impacted overall survival, indicating the need for careful monitoring of cardiac health in patients receiving RT.
Clinical features and long-term outcomes of patients with systemic polyarteritis nodosa diagnosed since 2005: Data from 196 patients.
J Autoimmun
September 2023
Department of Internal Medicine, Hôpital Cochin, AP-HP.Centre, Université Paris Cité, Paris, France; University Paris-Cité, F-75006, Paris, France. Electronic address:
Article Synopsis
- A retrospective study on polyarteritis nodosa (PAN) analyzed data from 196 patients referred to a French study group between 2005 and 2019, highlighting significant changes in the disease's landscape.
- Main symptoms included constitutional, neurological, skin, and musculoskeletal issues, with 28% of cases being secondary PAN due to conditions like myelodysplastic syndrome and cancers; most patients (98.5%) were treated with glucocorticoids.
- The study found high relapse rates associated with older age and specific clinical features, with mortality linked to factors like age, necrotic purpura, kidney injury, and secondary PAN, emphasizing the need for improved patient management.
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