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Now showing 1 - 10 of 1935
  • Publication
    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
  • Publication
    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.
  • Publication
    Co-clinical trials: An innovative drug development platform for cholangiocarcinoma
    (2021-01-01) Brinda Balasubramanian; Simran Venkatraman; Kyaw Zwar Myint; Tavan Janvilisri; Kanokpan Wongprasert; Supeecha Kumkate; David O. Bates; Rutaiwan Tohtong; University of Nottingham Medical School; Mahidol University
    of the conventional clinical trial process and propose the implementation of a novel concept, co-clinical trials to expedite drug development for CCA patients. In co-clinical trials, the preclinical studies and clinical trials are conducted simultaneously, thus... enabling real-time data integration to accurately stratify and customize treatment for patients, individually. Hence, co-clinical trials are expected to improve the outcomes of clinical trials and consequently, encourage the approval of targeted therapy
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    PublicationOpen Access
    Participants’ perceptions and understanding of a malaria clinical trial in Bangladesh
    (2014) Debashish Das; Cheah, Phaik Yeong; Fateha Akter; Dulal Paul; Akhterul Islam; Rasheda Samad; Ridwanur Rahman; Amir Hossain; Arjen Dondorp; Day, Nicholas P; White, Nicholas J; Mahtabuddin Hasan; Aniruddha Ghose; Ashley, Elizabeth A; Abul Faiz; Mahidol University. Faculty of Tropical Medicine. Mahidol-Oxford Tropical Medicine Research Unit
    Background: Existing evidence suggests that there is often limited understanding among participants in clinical trials about the informed consent process, resulting in their providing consent without really understanding the purpose of the study..., specific procedures, and their rights. The objective of the study was to determine the subjects’ understanding of research, perceptions of voluntariness and motivations for participation in a malaria clinical trial. Methods: In this study semi-structured
  • Publication
    CONVALESCENT plasma for COVID-19: A meta-analysis of clinical trials and real-world evidence
    (2021-11-01) Chiraphat Kloypan; Matthanaporn Saesong; Juthamat Sangsuemoon; Prawat Chantharit; Pajaree Mongkhon; University of Phayao; Charité – Universitätsmedizin Berlin; Faculty of Medicine Ramathibodi Hospital, Mahidol University; Chiang Mai University
    outcomes in COVID-19 patients. Methods: Cochrane Library, PubMed, EMBASE and ClinicalTrials.gov were searched from December 2019 to 16 July 2021, for data from clinical trials and observational studies. The primary outcome was all-cause mortality. Risk... estimates were pooled using a random-effect model. Risk of bias was assessed by Cochrane Risk of Bias tool for clinical trials and Newcastle-Ottawa Scale for observational studies. Results: In total, 18 peer-reviewed clinical trials, 3 preprints and 26
  • Publication
    The immediate effects of mobilization technique on pain and range of motion in patients presenting with unilateral neck pain: a randomized controlled trial
    (2009-02) Rotsalai Kanlayanaphotporn; Adit Chiradejnant; Roongtiwa Vachalathiti; Mahidol University. Faculty of Physical Therapy and Applied Movement Science
    : Triple-blind, randomized controlled trial. Setting: Outpatient physical therapy, institutional clinic. Participants: Patients (N=60), 2 physical therapists, and 1 assessor involved in this study. Interventions: The patients were randomly allocated...Kanlayanaphotporn R, Chiradejnant A, Vachalathiti R. The immediate effects of mobilization technique on pain and range of motion in patients presenting with unilateral neck pain: a randomized controlled trial. Arch Phys Med Rehabil 2009;90:187-92
  • PublicationOpen Access
    แบบฟอร์มสัญญาการวิจัยทางคลินิก มหาวิทยาลัยมหิดล
    (2564) ชนินาถ สุริยะลังกา; Chaninart Suriyalungga
    ยาก โดยบทความนี้จะสรุปเนื้อหาในแต่ละข้อของแบบฟอร์มสัญญาการวิจัยทางคลินิก มหาวิทยาลัยมหิดล (Clinical Trial Agreement Form, Mahidol University) เพื่อให้ผู้นำไปใช้เข้าใจได้ง่ายและตรงตามวัตถุประสงค์ในแบบฟอร์มสัญญาฯ... must make a clinical trial agreement form, Mahidol University. In order to bind both parties to achieve the objectives in the contract and is legally enforceable. Therefore, the agreement form must cover content as procuring drugs or equipment, rights
  • Publication
    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
  • Publication
    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
  • Publication
    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