he introduction of GM foods has led to the evolution of a food safety assessment paradigm that establishes safety of the GM food relative to its conventional counterpart. The GM foods currently approved and marketed in several countries have undergone extensive safety testing under a structured safety assessment framework evolved by international organizations like FAO, WHO, Codex and OECD. The major elements of safety assessment include molecular characterization of inserted genes and stability of the trait, toxicity and allergenicity potential of the expressed substances, compositional analysis, potential for gene transfer to gut microflora and unintentional effects of the genetic modification. As more number and type of food crops are being brought under the genetic modification regime, the adequacy of existing safety assessment protocols for establishing safety of these foods has been questioned. Such crops comprise GM crops with higher agronomic vigour, nutritional or health benefit/ by modification of plant metabolic pathways and those expressing bioactive substances and pharmaceuticals. The safety assessment challenges of these foods are the potential of the methods to detect unintentional effects with higher sensitivity and rigor. Development of databases on food compositions, toxicants and allergens is currently seen as an important aid to development of safety protocols. With the changing global trends in genetic modification technology future challenge would be to develop GM crops with minimum amount of inserted foreign DNA so as to reduce the burden of complex safety assessments while ensuring safety and utility of the technology.
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J Cardiopulm Rehabil Prev
January 2025
Author Affiliations: Department of Medicine, Cardiology Section, Boston Medical Center, Boston University School of Medicine, Boston, Massachusetts (Drs Washington-Plaskett and Gilman, Ms Zombeck, and Dr Balady), Biostatistics and Epidemiology Data Analytics Center, Boston University School of Public Health, Boston, Massachusetts (Ms Quinn).
Purpose: Uncovering the racial/ethnic health disparities that exist within cardiovascular medicine offers potential to mitigate treatment gaps that might affect outcomes. Socioeconomic status (SES) may be a more appropriate underlying factor to assess these disparities. We aimed to evaluate whether adherence, attendance, and outcomes in cardiac rehabilitation are associated with SES in a safety net hospital.
View Article and Find Full Text PDFPhotobiomodul Photomed Laser Surg
January 2025
Department of Dermatology, Southwest Hospital, Army Medical University, Chongqing, China.
Previous case reports hint ultraviolet A1 (UVA1) phototherapy as a novel adjunct treatment for acute cutaneous inflammations and neuralgia of herpes zoster, but its clinical effectiveness and safety in this condition are not yet proven by clinical trials. To determine the efficacy and safety of UVA1 phototherapy as an adjunct treatment for acute inflammation and neuralgia in herpes zoster. A total of 60 patients with moderate-to-severe acute herpes zoster were randomly divided into two parallel groups.
View Article and Find Full Text PDFJAMA Oncol
January 2025
Division of Hematologic Malignancies, Medical Oncology, Dana-Farber Cancer Institute, Boston, Massachusetts.
Importance: Although sharing care with local oncologists after allogeneic hematopoietic cell transplantation (HCT) has been proposed for patients living far from HCT centers, it is not known whether a shared strategy is safe or improves patient quality of life (QOL).
Objective: To determine the efficacy and safety of sharing follow-up care after HCT between the HCT specialty center and local oncologists.
Design, Setting, And Participants: This was a multicenter collaborative randomized clinical trial of patients undergoing HCT at Dana-Farber Cancer Institute (DFCI)-a high volume HCT center in Boston (Massachusetts)-and 8 local oncology practices.
JAMA Ophthalmol
January 2025
Xiamen Eye Center of Xiamen University, Xiamen, Fujian, China.
Importance: Bietti crystalline dystrophy (BCD) is a severe genetic retinopathy caused by variants in the CYP4V2 gene. Currently, there is no approved treatment for BCD.
Objective: To evaluate safety and vision outcomes following gene therapy with adeno-associated virus (AAV) encoding CYP4V2 (rAAV-hCYP4V2, NGGT001 [Next Generation Gene Therapeutics]).
Transl Vis Sci Technol
January 2025
Eye Institute and Department of Ophthalmology, Eye & ENT Hospital, Fudan University, Shanghai, China.
Purpose: The purpose of this study was to characterize whether pulsed ultrasound (PUS) affects transscleral drug delivery.
Methods: Fluorescein sodium (NaF, 376 Da) and fluorescein isothiocyanate-conjugated dextran 40 (FD-40, 40 kDa) were used as model drugs. Human sclera grafts were placed in modified Franz diffusion cells and were treated by PUS (1 megahertz [MHz], 0.
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