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    Systematic Review of Early Phase Pediatric Clinical Pharmacology Trials
    (2022-01-01) Subramanian D.; Mahidol University
    OBJECTIVE Children have generally been excluded from early-stage clinical trials owing to safety concerns based in social expectations and not data. However, the repositioning of adult therapeutics for pediatric use and the increase... in the development of therapies for pediatric only conditions require the participation of children in phase 1-2 trials. Therefore, the aim of this article is to systematically review the history and current state of early phase pediatric clinical pharmacology trials
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    How context can impact clinical trials: A multi-country qualitative case study comparison of diagnostic biomarker test interventions
    (2019-02-08) Marco J. Haenssgen; Nutcha Charoenboon; Nga T.T. Do; Thomas Althaus; Yuzana Khine Zaw; Heiman F.L. Wertheim; Yoel Lubell; University of Oxford, Saïd Business School; London School of Hygiene & Tropical Medicine; The University of Warwick; Mahidol University; Nuffield Department of Clinical Medicine; Medical Microbiology Department; Oxford University Clinical Research Unit (OUCRU)
    ?" Methods: We conducted a cross-case comparison of CRP point-of-care test trials across Yangon (Myanmar), Chiang Rai (Thailand), and Hanoi (Vietnam). Cross-sectional qualitative data were originally collected as part of each clinical trial to broaden... of transcripts and interview notes. Inductive thematic analysis was used to identify contextual factors and compare them across the three case studies. As clinical trial outcomes, we considered patients' and healthcare workers' adherence to the biomarker test
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    Factors related to volunteer comprehension of informed consent, for a clinical trial
    (2006-09-01) Nantawan Kaewpoonsri; Kamolnetr Okanurak; Dwip Kitayaporn; Jaranit Kaewkungwal; Saowanit Vijaykadga; Sopit Thamaree; Mahidol University; Bumrungrad International Hospital; Thailand Ministry of Public Health; Chulalongkorn University
    ' comprehension levels concerning the clinical trial and to find out factors associated with that comprehension levels. Eighty-one volunteers who enrolled in a malaria clinical trial were recruited into the study. A semi-structured questionnaire was used... and their attitude toward the consent process. The findings from this study demonstrate volunteers who participated in the clinical trial were not truly informed. Further studies regarding enhancing volunteers' understanding of the trial are needed.
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    A polyvalent DNA prime with matched polyvalent protein/GLA-SE boost regimen elicited the most robust and broad IgG and IgG3 V1V2 binding antibody and CD4+ T cell responses among 13 HIV vaccine trials
    (2025-01-01) Moodie Z.; Li S.S.; Giorgi E.E.; Williams L.T.D.; Dintwe O.; Carpp L.N.; Chen S.; Seaton K.E.; Sawant S.S.; Zhang L.; Heptinstall J.; Liu S.; Grunenberg N.; Tomaka F.; Rerks-Ngarm S.; Pitisuttithum P.; Nitayaphan S.; Ake J.A.; Vasan S.; Pantaleo G.; Frank I.; Baden L.R.; Goepfert P.A.; Keefer M.; Chirenje M.; Hosseinipour M.C.; Mngadi K.; Laher F.; Garrett N.; Bekker L.G.; De Rosa S.; Andersen-Nissen E.; Kublin J.G.; Lu S.; Gilbert P.B.; Gray G.E.; Corey L.; McElrath M.J.; Tomaras G.D.; Moodie Z.; Mahidol University
    provide strong support to test this promising HIV vaccine design in more advanced phase clinical trials and will also guide the future design of additional HIV vaccines. Trial registration:ClinicalTrials.gov identifier: NCT01799954. Trial registration:ClinicalTrials....gov identifier: NCT02109354. Trial registration:ClinicalTrials.gov identifier: NCT02404311. Trial registration:ClinicalTrials.gov identifier: NCT02207920. Trial registration:ClinicalTrials.gov identifier: NCT02296541. Trial registration:ClinicalTrials
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    Recognising the importance of the research nurse and study coordinators in enhancing retention of people with haemophilia in clinical trials
    (2023-01-01) Khair K.; Thykjaer H.; Barazani-Brutman T.; Vanderbilt K.B.; Benjamin C.; Wakefield C.; Williams N.; Wongwerawattanakoon P.; Zhong H.; Mulders G.; Khair K.; Mahidol University
    Introduction: For retention in clinical trials of investigational medical products (CTIMPS), the strategy and tactics to keep enrolled participants from discontinuing participation (dropouts) are important. Haemophilia trials often have extended... 1-5 or 6-10 clinical trial participants (46.6% and 36% respectively); the remainder reported 11-40 trial participants. The majority reported no or few participants dropping out of haemophilia clinical trials in the preceding three years (42.8% and 33
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    Clinical trials in acute ischemic stroke
    (2014-08-27) Kiyoshi Kikuchi; Eiichiro Tanaka; Yoshinaka Murai; Salunya Tancharoen; Mahidol University; Kurume University School of Medicine
    successfully has been beset by disappointments and setbacks. Many promising candidates have lacked significant pleiotropic protective activity for brain tissue and cerebral blood vessels in clinical trials, while those with protective activity have had poor... bioavailability or high toxicity. Moreover, the majority of agents did not confer significant neurovascular protection or clinical efficacy, as measured by standard behavioral endpoints in clinical trials of heterogeneous populations of patients with AIS
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    The WorldWide Antimalarial Resistance Network Clinical Trials Publication Library: A Live, Open-Access Database of Plasmodium Treatment Efficacy Trials
    (2020-07-01) Junko Takata; Paul Sondo; Georgina S. Humphreys; Rebekah Burrow; Brittany Maguire; Mohammad S. Hossain; Debashish Das; Robert J. Commons; Ric N. Price; Philippe J. Guerin; Menzies School of Health Research; Mahidol University; International Centre for Diarrhoeal Disease Research Bangladesh; Nuffield Department of Medicine; Infectious Diseases Data Observatory (IDDO); Institut de Recherche en Sciences de la Santé (IRSS)/Clinical Research Unit of Nanoro (CRUN); WorldWide Antimalarial Resistance Network (WWARN)
    the "WWARN clinical trials publication library," an open-access, up-to-date resource to streamline the synthesis of antimalarial safety and efficacy data. A series of iteratively refined database searches were conducted to identify prospective clinical trials... to explore the collective knowledge on antimalarial efficacy (available at https://www.wwarn.org/tools-resources/literature-reviews/wwarn-clinical-trials-publication-library). It is the first of its kind in the field of global infectious diseases, and lessons
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    The impact of the WOMAN trial on local clinical practice in Thailand
    (2025-01-01) Nivatpumin P.; Nithiuthai J.; Lertbunnaphong T.; Nivatpumin P.; Mahidol University
    in Thailand. Clinical trial registration: ClinicalTrials.gov registration number: NCT04833556 (registered April 6, 2021)....The World Maternal Antifibrinolytic (WOMAN) trial, published in 2017, was a multicenter, randomized controlled study. Its findings demonstrated that administering 1 g of tranexamic acid within 3 h postpartum can reduce maternal mortality due
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    Behind the scenes: Key lessons learned from the RELIEVE-AKI clinical trial
    (2024-10-01) Nikravangolsefid N.; Suppadungsuk S.; Singh W.; Palevsky P.M.; Murugan R.; Kashani K.B.; Nikravangolsefid N.; Mahidol University
    trial in determining the optimum net ultrafiltration rate. This paper outlines the relevant challenges and solutions in implementing this complex ICU-based trial. Several difficulties were encountered, starting with clinical issues related to conducting...Continuous kidney replacement therapy (CKRT) is commonly used to manage critically ill patients with severe acute kidney injury. While recent trials focused on the correct dosing and timing of CKRT, our understanding regarding the optimum dose
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    Phase II, multi-center, open-label, single-arm clinical trial evaluating the efficacy and safety of Mycophenolate Mofetil in patients with high-grade locally advanced or metastatic osteosarcoma (ESMMO): Rationale and design of the ESMMO trial
    (2020-03-30) Nut Koonrungsesomboon; Nuttapong Ngamphaiboon; Natavudh Townamchai; Pimpisa Teeyakasem; Chaiyut Charoentum; Pimlak Charoenkwan; Rungrote Natesirinilkul; Lalita Sathitsamitphong; Touch Ativitavas; Parunya Chaiyawat; Jeerawan Klangjorhor; Suradej Hongeng; Dumnoensun Pruksakorn; Chulalongkorn University; Faculty of Medicine, Ramathibodi Hospital, Mahidol University; Chiang Mai University
    , multi-center, open-label, single-arm, two-stage clinical trial. The main objectives of this study are to determine the efficacy and safety of mycophenolate mofetil in the patients. The primary endpoint is progression-free survival at 16 weeks... in the extension period. Discussion: This trial is the first step in the translation of therapeutic potential of mycophenolate mofetil emerging from in vitro and animal studies into the clinical domain. It is designed to assess the efficacy and safety