Saudi Cultural Missions Theses & Dissertations
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Item Restricted DESIGNING A CLINICAL TRIALS FRAMEWORK FOR WEARABLE TECHNOLOGIES AT SEHA VIRTUAL HOSPITAL IN SAUDI ARABIA(UCL, 2024) Madkhali, Marwan; Expert, PaulThe purpose of this research is to design a clinical trials framework for wearable technologies at Seha Virtual Hospital (SVH) in Saudi Arabia. The framework aims to evaluate the usability, effectiveness, and impact of wearable technologies on patient outcomes in a virtual care setting, aligning with the national strategy for digital health transformation. The research also seeks to establish benchmarks and generate high-quality evidence on the efficacy of these technologies for digital health in Saudi Arabia. The SVH, as a pioneering digital health centre, recognises the potential of wearable technologies to revolutionise healthcare by enabling remote monitoring and real-time data collection. The proposed framework will facilitate the integration of these technologies into clinical trials, contributing to evidence-based practices and improved patient care. The research methodology involved a systematic literature review to identify key themes and challenges in integrating wearable technologies into clinical trials. The review adhered to the PRISMA guidelines and included studies published between 2014 and 2024 that examined the use of wearable technologies in clinical trials for virtual healthcare delivery. Thematic analysis was employed to identify key themes and challenges. The findings highlighted the importance of usability and positive user experience, seamless data integration and high data quality, patient-centric design to promote adherence, the value of real-world evidence and feasibility studies, addressing regulatory and ethical considerations, and ensuring successful technology integration. The research also identified key benchmarks from existing clinical trials in different countries, including usability and patient-centred design, real-world data integration, methodological rigour and validation, ethical and regulatory compliance, personalised treatment plans and data accuracy, and hybrid models and flexibility. Results the comprehensive clinical trials framework was proposed. The framework incorporates needs assessment, technical performance evaluation, usability testing, feasibility assessment, and outcome measurement. It also emphasises ethical considerations, regulatory compliance, and data security. The implementation of this framework at SVH will enable the effective evaluation of wearable technologies, leading to improved patient monitoring, enhanced virtual care delivery, and ultimately, better patient outcomes. Keywords: clinical trials, wearable technologies, virtual healthcare, usability, and framework.10 0Item Restricted Mesenchymal Stem Cell Therapy in Retinitis Pigmentosa Patients: A Literature Review(Saudi Digital Library, 2023-12-01) Bushnag, Abdulkarim; Bainbridge, JamesBackground: Retinitis pigmentosa is a hereditary degenerative disorder of an autosomal dominant, autosomal recessive, or X-linked recessive inheritance pattern. It is also known as dystrophy of rod and cone as the major degeneration occur in the photoreceptor rods with minor degeneration of cones. The early stage of the disease involves night vision loss and limited peripheral vision, whereas the later stages involve the loss of color vision and central vision. There is no curative treatment for retinal disorders; however, several treatment strategies are involved such as stem cell therapy, and gene therapy. Mesenchymal stem cells are a non-hematopoietic clonogenic, multipotent, heterogeneous subset of the stem cell population that can be isolated from many sources of adult tissues and have the capability to differentiate into various types of specialized cells. Therefore, they are widely used in tissue engineering and regenerative medicine for their self-renewal, immunomodulatory, and pluripotency characteristics and they can be a promising treatment for retinitis pigmentosa. Objective: This literature review aims to discuss the use of mesenchymal stem cells transplantation for the treatment of retinitis pigmentosa and assess the outcomes of this therapy and its usefulness. Methods: A literature was conducted using Ovid MEDLINE, Ovid Embase, and the Cochrane Database of Systematic Reviews in the Cochrane Library. Keywords such as "MSC, Mesenchymal stem cell, Mesenchymal stem cell transplantation, Stem cell therapy, stem cell treatment, Regenerative medicine, Cell-based Therapy, bone marrow-derived stem cell, adipose tissue-derived stem cell, umbilical cord-derived stem cell, RP, and Retinitis Pigmentosa." were used for the searching process. Trials published in English with in the years between 2013 and 2023 were evaluated. Results: A total of eleven trials were included; two were preclinical and nine trials were clinical. The assessed mesenchymal stem cells included those derived from adipose tissue, bone marrow, umbilical cord and Warton jelly cells. The outcomes and complications of each type were discussed. Conclusion: The effectiveness and outcomes of MSCs treatment for RP varied between different types of MSCs used in therapy. Umbilical cord-derived mesenchymal stem cells resulted in better outcomes compared to other types of cells. However, the evidence of using MSCs for RP treatment is weak and there is a need for strong evidence on the effectiveness of MSCs for RP treatment. Therefore, MSCs may not be a promising treatment for RP as it was expected.17 0Item Restricted PHARMACOKINETIC AND PHARMACODYNAMIC MODELING FOR OPTIMIZING COMBINATION THERAPY(Saudi Digital Library, 2023) Almoslem, Mohammed; Schmidt, StephanThis dissertation highlights the application of model-informed drug development approaches to optimize combination (chemo)therapy. Chapter 1 provides a general overview of pharmacokinetic (PK) / pharmacodynamic (PD) concepts used to characterize the relationship between drug exposure and desired as well as undesired pharmacodynamic effect(s) by highlighting key processes along the causal pathway between drug administration and effect. Chapter 2 expands on the concepts outlined for a single drug in Chapter 1 to two-drug regimens in order to be able to characterize and predict the effect of combination (chemo)therapy. These 2 introductory chapters are followed by distinct preclinical (Chapter 3 and Chapter 4) and clinical (Chapter 5) case examples that showcase PK/PD approaches used to identify optimal combination (chemo)therapy regimens. Chapter 3 and Chapter 4 focus on anti-infective applications, where in vitro data is used to identify optimal two-drug regimens against Mycobacterium tuberculosis in different metabolic states (Chapter 3), and three-drug regimens against Mycobacterium tuberculosis in non-human primates were examined (Chapter 4). Chapter 5 focuses on a clinical application in preterm neonates. An innovative time-to-event analysis is used in this chapter to identify optimal ibuprofen/acetaminophen combination regimens to expedite ductus arteriosus closure in this vulnerable special patient population. Finally, Chapter 6 summarizes the knowledge gained from these projects, highlighting the application of PKPD modeling in optimizing treatment regimens and identifying optimal drug combinations across diverse therapeutic areas and stages of drug development. The findings presented in this dissertation are intended to assist researchers and clinicians in improving treatment outcomes, particularly in complex conditions requiring combination therapy.30 0