Phase 1 clinical research trials using healthy volunteers are conducted for the sole purpose of serving the public good (a utilitarian concept). The literature on equipoise analysis does not exclude phase 1 trials with controls or healthy volunteers from the claim of being in "equipoise." The continued perpetuation of this ethically and scientifically invalid concept undermines the ethics of research with human subjects.
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Infect Dis Ther
January 2025
ViiV Healthcare, Madrid, Spain.
Introduction: Dolutegravir (DTG) + lamivudine (3TC) demonstrated high rates of virologic suppression (VS) and low rates of virologic failure (VF), discontinuation, and drug resistance in randomized trials. Real-world evidence can support treatment effectiveness, safety, and tolerability in clinical practice and aid in treatment decisions.
Methods: A systematic literature review (SLR) was conducted to identify studies using DTG + 3TC (January 2013-March 2024).
Dysphagia
January 2025
Faculty of Physical Therapy and Rehabilitation, Hacettepe University, Ankara, Turkey.
This study aimed to develop the 'Fear of Feeding My Child- A Parental Report (FF-PR)', which measures the parental fear of feeding their children, and to determine its reliability and validity. The study consists of the developmental phase and reported the content validity, internal consistency, test-retest reliability, construct, criterion, and discriminant validity. The study included two groups; 'Group I (N = 90)' who had a neurological disorder and their parents, and 'Group II (N = 60)' who were typically developing children without any feeding and swallowing problems and their parents.
View Article and Find Full Text PDFArch Dermatol Res
January 2025
Division of Gastroenterology and Hepatology, 200 1st Street SW, Rochester, MN, 55905, USA.
Background: Celiac disease (CeD) has shown an association with autoimmune disorders including vitiligo and alopecia areata (AA). Ritlecitinib, a JAK3 and TEC kinase family inhibitor, has been approved for treatment of patients with AA and is in late-stage development for vitiligo. Ritlecitinib inhibits cytotoxic T cells, NK cells, and B cells which play a role in the pathogenesis of CeD.
View Article and Find Full Text PDFCancer Commun (Lond)
January 2025
Department of Medical Oncology, Cancer Hospital, Harbin Medical University, Harbin, Heilongjiang, P. R. China.
Background: The standard first-line treatment for human epidermal growth factor receptor 2 (HER2)-positive recurrent/metastatic breast cancer currently includes pertuzumab plus trastuzumab and docetaxel. This study aimed to evaluate the effectiveness of KN026, an anti-HER2 bispecific antibody, plus docetaxel in first-line treatment of HER2-positive recurrent/metastatic breast cancer.
Methods: This open-label, single-arm, phase II study enrolled patients with HER2-positive recurrent/metastatic breast cancer in 19 centers across China from December 30, 2019 to May 27, 2021.
Tumour 'bulk' has historically been considered an important prognostic marker and clinical tool to guide treatment in patients with lymphoma. However, its use and definitions in trial designs varies significantly and it is unclear how this has influenced the relevance of bulk in contemporary practice. This comprehensive literature review evaluated the definitions, applications and prognostic impact of bulk in phase 3 randomised trials in four major lymphoma subtypes.
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