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Item Metadata only Systematic Review of Early Phase Pediatric Clinical Pharmacology Trials(2022-01-01) Subramanian D.; Mahidol UniversityOBJECTIVE 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 trialsItem Metadata only Factors affecting HIV-Infected patients intention in clinical trial participation(Mahidol University. Mahidol University Library and Knowledge Center, 2014) Siriwan Thitiphongpraphat; Pirudee Pavananunt; Supreya Tansakul; Sasisopin KiertiburanakulThe number of clinical trials has been increasing dramatically in Asia due to several reasons. Many researchers have been discovering the reasons why some patients decide to participate in these trials, but there is not enough evidence... that such an inquiry has been studied in the Thai population. This research was to identify factors affecting the intention of HIV-infected patients to participate in a clinical trial by using the Health Belief Model (HBM). A structured questionnaire was developedPublication Metadata only 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 testPublication Metadata only 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 Metadata only 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 Universityof 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 therapyItem Metadata only 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 Universityprovide 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:ClinicalTrialsPublication Open 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 UnitBackground: 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-structuredPublication Metadata only 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 Universityoutcomes 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 26Publication Metadata only 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;90:187-92Publication Open Access แบบฟอร์มสัญญาการวิจัยทางคลินิก มหาวิทยาลัยมหิดล(2564) ชนินาถ สุริยะลังกา; Chaninart Suriyalunggaยาก 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