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Selected aspects of methotrexate treatment in patients with rheumatoid arthritis
Hloch, Karel ; Pávek, Petr (advisor) ; Souček, Miroslav (referee) ; Tomčík, Michal (referee)
Charles University, Faculty of Pharmacy in Hradec Králové Training Workplace Department of Social and Clinical Pharmacy Doctoral Degree Program Clinical and Social Pharmacy Candidate MSc. Karel Hloch Supervisor prof. PharmD. Petr Pávek, Ph.D. Advisor assoc. prof. MUDr. Tomáš Soukup, Ph.D.; PharmD. Martin Doseděl, Ph.D. Title of Doctoral Thesis: Selected aspects of methotrexate treatment in patients with rheumatoid arthritis Introduction and objectives Rheumatoid arthritis (RA) is an autoimmune disease typically connected with chronic inflammation of the joints, causing their swelling and pain. The prevalence of RA is about 1% in the general population. A crucial role in higher morbidity and mortality in RA patients has been associated with increased inflammatory activity. Methotrexate (MTX), a drug with immunosuppressive activity, is the most frequent drug of choice used in RA therapy. It seems that main anti-inflammatory effect is mediated via release of purine nucleoside adenosine. The status of patients with inflammatory diseases is influenced by activation of A2a and A3 adenosine receptors. High caffeine (adenosine receptor antagonist) consumption may therefore lead to alteration of MTX treatment efficacy. 1) The aim of first study was to determine whether RA patients who had discontinued...
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Selected aspects of methotrexate treatment in patients with rheumatoid arthritis
Hloch, Karel ; Pávek, Petr (advisor) ; Souček, Miroslav (referee) ; Tomčík, Michal (referee)
Charles University, Faculty of Pharmacy in Hradec Králové Training Workplace Department of Social and Clinical Pharmacy Doctoral Degree Program Clinical and Social Pharmacy Candidate MSc. Karel Hloch Supervisor prof. PharmD. Petr Pávek, Ph.D. Advisor assoc. prof. MUDr. Tomáš Soukup, Ph.D.; PharmD. Martin Doseděl, Ph.D. Title of Doctoral Thesis: Selected aspects of methotrexate treatment in patients with rheumatoid arthritis Introduction and objectives Rheumatoid arthritis (RA) is an autoimmune disease typically connected with chronic inflammation of the joints, causing their swelling and pain. The prevalence of RA is about 1% in the general population. A crucial role in higher morbidity and mortality in RA patients has been associated with increased inflammatory activity. Methotrexate (MTX), a drug with immunosuppressive activity, is the most frequent drug of choice used in RA therapy. It seems that main anti-inflammatory effect is mediated via release of purine nucleoside adenosine. The status of patients with inflammatory diseases is influenced by activation of A2a and A3 adenosine receptors. High caffeine (adenosine receptor antagonist) consumption may therefore lead to alteration of MTX treatment efficacy. 1) The aim of first study was to determine whether RA patients who had discontinued...
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Electronic clinical study management system with artificial intelligence-based data processing capabilities
Mužný, Miroslav ; Mužík, Jan (advisor) ; Štěpánková, Olga (referee) ; Ngo, Phuong Dinh (referee)
An increasing amount of data are collected through wearable devices during ambulatory, and long-term monitoring of biological signals, adoption of persuasive technology and dynamics of clinical trials information sharing - all of that changes the possible clinical intervention. Moreover, more and more smartphone apps are hitting the market as they become a tool in daily life for many people around the globe. All of these applications are generating a tremendous amount of data, that is difficult to process using traditional methods, and asks for engagement of advanced methods of data processing. For recruiting patients, this calls for a shift from traditional methods of engaging patients to modern communication platforms such as social media, that are providing easy access to up- to-date information on an everyday basis. These factors make the clinical study progression demanding, in terms of unified participant management and processing of connected digital resources. Some clinical trials put a strong accent on remote sensing data and patient engagement through their smartphones. To facilitate this, a direct participant messaging, where the researchers give support, guidance and troubleshooting on a personal level using already adopted communication channels, needs to be implemented. Since the...
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Electronic clinical study management system with artificial intelligence-based data processing capabilities
Mužný, Miroslav ; Mužík, Jan (advisor) ; Štěpánková, Olga (referee) ; Ngo, Phuong Dinh (referee)
An increasing amount of data are collected through wearable devices during ambulatory, and long-term monitoring of biological signals, adoption of persuasive technology and dynamics of clinical trials information sharing - all of that changes the possible clinical intervention. Moreover, more and more smartphone apps are hitting the market as they become a tool in daily life for many people around the globe. All of these applications are generating a tremendous amount of data, that is difficult to process using traditional methods, and asks for engagement of advanced methods of data processing. For recruiting patients, this calls for a shift from traditional methods of engaging patients to modern communication platforms such as social media, that are providing easy access to up- to-date information on an everyday basis. These factors make the clinical study progression demanding, in terms of unified participant management and processing of connected digital resources. Some clinical trials put a strong accent on remote sensing data and patient engagement through their smartphones. To facilitate this, a direct participant messaging, where the researchers give support, guidance and troubleshooting on a personal level using already adopted communication channels, needs to be implemented. Since the...
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Variability of pharmacokinetics and possibilities for its monitoring.
Světlík, Svatopluk ; Slanař, Ondřej (advisor) ; Čabala, Radomír (referee) ; Paluch, Zoltán (referee)
Backgroun and aims: Pharmacokinetic variability is of paramount importance for sucessfull pharmacotherapy. The main purpose of this work was to study variability of pharmacokinetics in clinical and non-clinical setting with the aim to predict variability in target population. Specifically, three drugs were chosen, sufentanil, with relativelly narrow therapeutic index, and nabumeton and abirateron, both with known high variability. Methods: The study of pharmacokinetic variability of sufentanil was based on clinical samples taken from patients undergoing surgical cardiac procedure, where the sufentanil was used as a part of the drug coctail used during the procedure. New analytical method was necessary to prepare and validate to measure sufentanil concentrations and obtain pharmacokinetic parameters. These were compared between determined genotype groups of MDR1 and OPRM1. Similarly, clinical study was executed with nabumetone, in which nabumetone was administered in a group of 24 subjects on two separate occassions. Plazma samples were obtained and concentrations of nabumetone and its active metabolite, 6-methoxynaphtylacetic acid (6-MNA), were determined. Obtained pharmacokinetic profiles were compared between female and male volunteers, and genotypes for MDR1 and CYP2D6. Finaly for abiraterone,...
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Clinical trials of medical products for human use in the Czech Republic
Baloušek, Filip ; Kryska, David (advisor) ; Svoboda, Petr (referee)
The issue of legislative and ethical requirements on research of innovative medicines became more intense in connection to the expansion of the pharmaceutical industry in last few decades. This master thesis aims to complexly describe and analyse theoretical bases of current legislative regulating the process of clinical trials of medicinal products for human use in the Czech Republic, as well as to take a closer look to the issue of ethical review administered by specialized ethical review committees. The author also deals with some specific responsibilities of the committees from the perspective of administrative law, especially focusing on aspects of legal nature of the positive opinions, which are one of the conditions for commencement of a clinical trial. The thesis is divided into nine chapters and the introductory chapter is focused on the general outline of the issue of clinical trials of medicines for human use in the Czech Republic. The aim of the second chapter is to define the basic concepts stated in the Czech medicinal products act, which are specific for this area of pharmaceutical law. The next chapter analyses the relevant competencies of individual state authorities over the clinical studies. The fourth chapter contains the list of sources of law, whereas a particular emphasis is...
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