Displaying publications 1 - 20 of 156 in total

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  1. "Preliminary report of the beneficial effect of chloromycetin in the treatment of typhoid fever"--a commentary
    Basnyat B
    Wilderness Environ Med, 2004;15(3):216-7.
    PMID: 16331874
    Matched MeSH terms: Controlled Clinical Trials as Topic/history
  2. Fulltext Structure-Based Design of Antivirals against Envelope Glycoprotein of Dengue Virus
    Anasir MI, Ramanathan B, Poh CL
    Viruses, 2020 03 26;12(4).
    PMID: 32225021 DOI: 10.3390/v12040367
    Dengue virus (DENV) presents a significant threat to global public health with more than 500,000 hospitalizations and 25,000 deaths annually. Currently, there is no clinically approved antiviral drug to treat DENV infection. The envelope (E) glycoprotein of DENV is a promising target for drug discovery as the E protein is important for viral attachment and fusion. Understanding the structure and function of DENV E protein has led to the exploration of structure-based drug discovery of antiviral compounds and peptides against DENV infections. This review summarizes the structural information of the DENV E protein with regards to DENV attachment and fusion. The information enables the development of antiviral agents through structure-based approaches. In addition, this review compares the potency of antivirals targeting the E protein with the antivirals targeting DENV multifunctional enzymes, repurposed drugs and clinically approved antiviral drugs. None of the current DENV antiviral candidates possess potency similar to the approved antiviral drugs which indicates that more efforts and resources must be invested before an effective DENV drug materializes.
    Matched MeSH terms: Clinical Trials as Topic
  3. Fulltext Willingness to Participate and Associated Factors in a Zika Vaccine Trial in Indonesia: A Cross-Sectional Study
    Harapan H, Mudatsir M, Yufika A, Nawawi Y, Wahyuniati N, Anwar S, et al.
    Viruses, 2018 11 18;10(11).
    PMID: 30453663 DOI: 10.3390/v10110648
    One of the crucial steps during trials for Zika and other vaccines is to recruit participants and to understand how participants' attitudes and sociodemographic characteristics affect willingness to participate (WTP). This study was conducted to assess WTP, its explanatory variables, and the impact of financial compensation on WTP in Indonesia. A health facility-based cross-sectional study was conducted in eleven regencies in the Aceh and West Sumatra provinces of Indonesia. Participants were recruited via a convenience sampling method and were interviewed. The associations between explanatory variables and WTP were assessed using a two-step logistic regression analysis. A total of 1,102 parents were approached, and of these 956 (86.8%) completed the interview and were included in analysis. Of those, 144 (15.1%) were willing to participate in a Zika vaccine trial without a financial compensation. In the multivariate analysis, WTP was tied to an age of more than 50 years old, compared to 20⁻29 years (odds ratio (OR): 5.0; 95% confidence interval (CI): 2.37⁻10.53), to being female (OR: 2.20; 95% CI: 1.11⁻4.37), and to having heard about Zika (OR: 2.41; 95% CI: 1.59⁻3.65). Participants' WTP increased gradually with higher financial compensation. The rate of WTP increased to 62.3% at the highest offer (US$ 350.4), and those who were still unwilling to participate (37.7%) had a poorer attitude towards childhood vaccination. This study highlights that pre-existing knowledge about Zika and attitudes towards childhood vaccination are important in determining community members being willing to participate in a vaccine trial. Financial incentives are still an important factor to enhance participant recruitment during a vaccine trial.
    Matched MeSH terms: Clinical Trials as Topic*
  4. Fulltext Statins in heart failure: do we need another trial?
    Bonsu KO, Kadirvelu A, Reidpath DD
    Vasc Health Risk Manag, 2013;9:303-19.
    PMID: 23807852 DOI: 10.2147/VHRM.S44499
    Statins lower serum cholesterol and are employed for primary and secondary prevention of cardiovascular events. Clinical evidence from observational studies, retrospective data, and post hoc analyses of data from large statin trials in various cardiovascular conditions, as well as small scale randomized trials, suggest survival and other outcome benefits for heart failure. Two recent large randomized controlled trials, however, appear to suggest statins do not have beneficial effects in heart failure. In addition to lowering cholesterol, statins are believed to have many pleotropic effects which could possibly influence the pathophysiology of heart failure. Following the two large trials, evidence from recent studies appears to support the use of statins in heart failure. This review discusses the role of statins in the pathophysiology of heart failure, current evidence for statin use in heart failure, and suggests directions for future research.
    Matched MeSH terms: Clinical Trials as Topic*
  5. Fulltext Status of research and development of vaccines for enterovirus 71
    Reed Z, Cardosa MJ
    Vaccine, 2016 06 03;34(26):2967-2970.
    PMID: 26973065 DOI: 10.1016/j.vaccine.2016.02.077
    Although outbreaks of Hand, Foot, and Mouth Disease (HFMD) in young children have long been recognized worldwide, the occurrence of rare and life-threatening neurological, respiratory, and cardiac complications has propelled this common condition into the spotlight as a major public health problem in the affected countries. Various enteroviruses cause HFMD, but the severe complications have been mostly associated with enterovirus 71 (EV71). Medical treatment is supportive and measures to interrupt transmission have been challenging to implement. Preventive vaccines could have an important clinical impact, especially among children younger than 3 years old who are most susceptible to the neurological complications. Several groups in the highly affected Asia-Pacific region are working towards vaccines against EV71 and some candidates have progressed to late-stage clinical trials with two vaccines recently reported to have been approved by the regulatory authorities in China. This report summarizes current issues and progress in the development of vaccines against EV71.
    Matched MeSH terms: Clinical Trials as Topic
  6. Effectiveness of intensive perioperative nutrition therapy among adults undergoing gastrointestinal and oncological surgery in a public hospital: study protocol for a pragmatic randomized control trial
    A'zim AZA, Zaid ZA, Yusof BNM, Jabar MF, Shahar ASM
    Trials, 2022 Nov 26;23(1):961.
    PMID: 36435838 DOI: 10.1186/s13063-022-06898-2
    BACKGROUND: Perioperative malnutrition is common in patients undergoing gastrointestinal-oncology surgery and is associated with longer hospital stays, increased postoperative complications, poorer quality of life, and lower survival rates. Current practice emphasizes the role of early perioperative nutrition therapy as an early intervention to combat the postoperative complications of patients and the implementation is now widely adopted. However, there is still a lack of research on determining the effectiveness of intensive nutrition therapy and providing ONS perioperative locally. This becomes the significance of this study and serves as a basis for management and guideline in the local hospital settings.

    METHODS: This is a pragmatic randomized control trial study where elective admitted patients will be randomly divided into the intervention (SS) or control (NN) group. All data will be collected during a face-to-face interview, anthropometric measurement, blood sampling (albumin, white blood count, hemoglobin, and c-reactive protein), handgrip strength, and postoperative complications. Group SS will be receiving a tailored lifestyle and intensively supplemented with oral nutrition support as compared to Group NN that will receive standard medical care. The primary outcome for this study is the length of stay in the hospital. Additional outcome measures are changes in biochemical profile and nutritional and functional status. The effects of intervention between groups on the outcome parameters will be analyzed by using the SPSS General Linear Model (GLM) for the repeated measure procedure.

    DISCUSSION: The intervention implemented in this study will serve as baseline data in providing appropriate nutritional management in patients undergoing gastrointestinal and oncological surgery.

    TRIAL REGISTRATION: ClinicalTrials.gov Protocol Registration and Results System (PRS) NCT04347772 . Registered on 20 November 2019.

    Matched MeSH terms: Pragmatic Clinical Trials as Topic
  7. Fulltext One Size Does Not Fit All: Developing Common Standards for Outcomes in Early-Phase Clinical Trials of Sound-, Psychology-, and Pharmacology-Based Interventions for Chronic Subjective Tinnitus in Adults
    Hall DA, Hibbert A, Smith H, Haider HF, Londero A, Mazurek B, et al.
    Trends Hear, 2019 2 26;23:2331216518824827.
    PMID: 30803389 DOI: 10.1177/2331216518824827
    Good practice in clinical trials advocates common standards for assessing and reporting condition-specific complaints ("outcome domains"). For tinnitus, there is no common standard. The Core Outcome Measures in Tinnitus International Delphi (COMiT'ID) study created recommendations that are relevant to the most common intervention approaches for chronic subjective tinnitus in adults using consensus methods. Here, the objectives were to examine why it is important to tailor outcome domain selection to the tinnitus intervention that is being evaluated in the clinical trial and to demonstrate that the COMiT'ID recommendations are robust. The COMiT'ID study used an online three-round Delphi method with three separate surveys for sound-, psychology-, and pharmacology-based interventions. Survey data were analyzed to assess quality and confidence in the consensus achieved across surveys and stakeholder groups and between survey rounds. Results found participants were highly discriminatory in their decision-making. Of the 34 outcome domains reaching the prespecified consensus definition in the final round, 17 (50%) were unique to one intervention, while only 12 (35%) were common to all three. Robustness was demonstrated by an acceptable level of agreement across and within stakeholder groups, across survey rounds, across medical specialties (for the health-care practitioners), and across health-care users with varying tinnitus duration. There were few dissenting voices, and results showed no attrition bias. In conclusion, there is compelling evidence that one set of outcomes does not fit all therapeutic aims. Our analyses evidence robust decisions by the electronic Delphi process, leading to recommendations for three unique intervention-specific outcome domain sets. This provides an important starting point for standardization.
    Matched MeSH terms: Clinical Trials as Topic
  8. Fulltext The COMiT'ID Study: Developing Core Outcome Domains Sets for Clinical Trials of Sound-, Psychology-, and Pharmacology-Based Interventions for Chronic Subjective Tinnitus in Adults
    Hall DA, Smith H, Hibbert A, Colley V, Haider HF, Horobin A, et al.
    Trends Hear, 2018;22:2331216518814384.
    PMID: 30488765 DOI: 10.1177/2331216518814384
    Subjective tinnitus is a chronic heterogeneous condition that is typically managed using intervention approaches based on sound devices, psychologically informed therapies, or pharmaceutical products. For clinical trials, there are currently no common standards for assessing or reporting intervention efficacy. This article reports on the first of two steps to establish a common standard, which identifies what specific tinnitus-related complaints ("outcome domains") are critical and important to assess in all clinical trials to determine whether an intervention has worked. Using purposive sampling, 719 international health-care users with tinnitus, health-care professionals, clinical researchers, commercial representatives, and funders were recruited. Eligibility was primarily determined by experience of one of the three interventions of interest. Following recommended procedures for gaining consensus, three intervention-specific, three-round, Delphi surveys were delivered online. Each Delphi survey was followed by an in-person consensus meeting. Viewpoints and votes involved all stakeholder groups, with approximately a 1:1 ratio of health-care users to professionals. "Tinnitus intrusiveness" was voted in for all three interventions. For sound-based interventions, the minimum set included "ability to ignore," "concentration," "quality of sleep," and "sense of control." For psychology-based interventions, the minimum set included "acceptance of tinnitus," "mood," "negative thoughts and beliefs," and "sense of control." For pharmacology-based interventions, "tinnitus loudness" was the only additional core outcome domain. The second step will next identify how those outcome domains should best be measured. The uptake of these intervention-specific standards in clinical trials will improve research quality, enhance clinical decision-making, and facilitate meta-analysis in systematic reviews.
    Matched MeSH terms: Clinical Trials as Topic/standards*
  9. Prophylactic and sporontocidal treatment of chloroquine resistant Plasmodium falciparum from Malaya
    Clyde DF, DuPont HL, Miller RM, McCarthy VC
    Trans R Soc Trop Med Hyg, 1970;64(6):834-8.
    PMID: 4924648
    Matched MeSH terms: Clinical Trials as Topic
  10. Percutaneous endoscopic gastrostomy versus nasogastric feeding in older individuals with non-stroke dysphagia: a systematic review
    Jaafar MH, Mahadeva S, Morgan K, Tan MP
    J Nutr Health Aging, 2015 Feb;19(2):190-7.
    PMID: 25651445 DOI: 10.1007/s12603-014-0527-z
    OBJECTIVE: The objective of this systematic review was to evaluate existing studies on the effectiveness of percutaneous endoscopic gastrostomy (PEG) feeding compared to nasogastric (NG) feeding for patients with non-stroke related dysphagia.

    METHODS: We searched Ovid MEDLINE, EMBASE, the Cochrane Library, Web of Science and PubMed databases through to December 2013 using the terms "percutaneous endoscopic gastrostomy", "gastrostomy", "PEG", "nasogastric", "nasogastric tube", "nasogastric feeding" and "intubation". We included randomized controlled trials (RCTs) and non-RCTs which compared PEG with NG feeding in individuals with non-stroke dysphagia.

    RESULTS: 9 studies involving 847 participants were included in the final analysis, including two randomized trials. Pooled analysis indicated no significant difference in the risk of pneumonia [relative risk (RR) = 1.18, 95% confidence interval (CI) = 0.87-1.60] and overall complications [relative risk (RR) = 0.80, 95% confidence interval (CI) = 0.63-1.02] between PEG and NG feeding. A meta-analysis was not possible for mortality and nutritional outcomes, but three studies suggested improved mortality outcomes with PEG feeding while two out of three studies reported PEG feeding to be better from a nutritional perspective.

    CONCLUSIONS: Firm conclusions could not be derived on whether PEG feeding is beneficial over NG feeding in older persons with non-stroke dysphagia, as previously published literature were unclear or had a high risk of bias. A well-designed and adequately powered RCT, which includes carer strain and quality of life as outcome measures is therefore urgently needed.

    Matched MeSH terms: Clinical Trials as Topic
  11. Giving bednets "fair" tests in field trials against malaria:a case from Sabah, East Malaysia
    Leake DW, Hii JL
    Southeast Asian J. Trop. Med. Public Health, 1989 Sep;20(3):379-84.
    PMID: 2699084
    Insecticide-impregnated bednets appear to be a potentially cost-effective intervention against endemic malaria in the tropics, but this has yet to be confirmed by field trials. There are two aspects to consider in assessing such trials: (1) the extent to which subjects use nets regularly and properly, and (2) the effectiveness of nets which are truly used regularly and properly in reducing malaria transmission. The second aspect is currently of primary concern, to determine if human-vector relationships for a particular at-risk population are such that bednets can be effective. But to give bednets a "fair" test in this regard requires regular and proper use in the first place. The study described here suggests they did not get a "fair" test in one field trial in Sabah, East Malaysia. The study also strongly suggests that direct observations, rather than post hoc questioning of subjects, may be essential to accurately gauge bednet usage rates. Accurate usage rates are required to determine what proportion of a population needs to use nets to reduce malaria transmission, and to evaluate the effectiveness of promotional programs over time. Direct observations can also yield valuable data on night-time activities that increase malaria risk, such as television viewing that keeps people awake and out of bednets.
    Matched MeSH terms: Clinical Trials as Topic
  12. Seeking the ideal anti-hypertensive agent: a practical review of the hypertension drug trials
    Ong HT, Cheah JS
    N Z Med J, 2004 Feb 20;117(1189):U773.
    PMID: 15014562
    Numerous trials and meta-analyses have been conducted over the last five years to identify an ideal anti-hypertensive drug. These reports, and the JNC 7 and European hypertension guidelines, have generated some controversy and confusion. A review of the comparative anti-hypertensive drug trials shows that the differences between drugs are minor and not consistently demonstrated by different studies. However, much data have now accumulated on the safety and value of diuretics, beta blockers, calcium-channel blockers (CCBs), angiotensin-converting enzyme inhibitors (ACEIs), and angiotensin receptor blockers (ARBs) in reducing blood pressure and preventing clinical disease. The importance of tight blood pressure control in reducing adverse events has been clearly shown, and clinicians should concentrate on achieving target blood pressure levels, which often requires a combination of anti-hypertensive drugs. The choice of anti-hypertensive drug should be guided by the presence of concomitant clinical disease, as evidence has accumulated on the special efficacy of certain drugs in reducing damage to particular organ systems. In the absence of any associated clinical disease, it is good to initiate anti-hypertensive therapy with diuretics, provided the metabolic parameters are regularly reviewed.
    Matched MeSH terms: Clinical Trials as Topic
  13. Fulltext Critical appraisal of the existing and emerging therapies for smoking cessation
    Bhutani G, Kaushal J, Gupta MC
    Med J Malaysia, 2011 Dec;66(5):526-33.
    PMID: 22390122
    Smoking is a major health problem of the society as it causes a wide variety of health hazards and produces a strong addictive behavior. Various pharmacological and non pharmacological treatments have been tried for smoking cessation from time to time. Some of the pharmacological treatments have been able to achieve the status of first line and second line therapy for smoking cessation by the US Public Health Service Clinical Practice Guideline. Some newer and very promising drugs have come up and are in the clinical trials for establishment of their efficacy. While some other drugs have been tried from time to time but have failed to show any consistent results. Various non pharmacological therapies like behavioural therapy are also of utmost importance in this regard. This article gives a brief review and critical assessment of the existing and the emerging smoking cessation therapies.
    Non-Malaysian publication: India
    Matched MeSH terms: Clinical Trials as Topic
  14. Fulltext Investigator-initiated clinical trials in Malaysia and the role of the Clinical Research Centre of the Ministry of Health
    Sivanandam AF, Hon YK, Yuen S, Muninathan P, Goh PP, Lim TO
    Med J Malaysia, 2010 Jun;65 Suppl A:138-42.
    PMID: 21488475
    The objective of this review is to better understand the concept of investigator-initiated trials and its benefits. While investigator-initiated trials can be an invaluable tool, there are several challenges in its initiation and management. However, it is for these reasons that Clinical Research Centre (CRC) had developed the Investigator Initiated Trial (IIT) Programme where financial support and technical assistance are provided to local investigators embarking on their own clinical trials. In the course of preparing the review, we found that the inclination of investigator-initiated trials has yet to be well established in Ministry of Health, Malaysia. Given the potential and impact of such trials, clinicians should be aware of their ability as well as the availability of a supportive network in mobilising their concerted research efforts. Greater research collaboration among investigators could foster more innovative, insightful and constructive research.
    Matched MeSH terms: Clinical Trials as Topic
  15. Fulltext The National Medical Research Register--a vital link between current and future research
    Lim TO, Asmaliza SI, Goh PP, Michael AJ, Hon YK, Thandapani R, et al.
    Med J Malaysia, 2010 Jun;65 Suppl A:124-7.
    PMID: 21488472
    Registration of research proposal to a publicly accessible website with searchable function allows information sharing and ensures research transparency. The National Institutes of Health Malaysia, realising the importance of research registration, established the National Medical Research Register (NMRR) in 2007. The NMRR functions more than just a local register: it also links to ethics approval and MOH medical research grant application. It thus facilitates researchers in their application to the Ministry of Health Research and Ethics Committee (MREC) and for Ministry of Health research grant. In addition, MREC committee members can review research protocol on NMRR website, thus saving much time and resources. From May 2007 till December 2009, more than 3000 people have registered as NMRR public users and more than 1000 research proposals have been uploaded in NMRR. The number of registration of research proposals, clinical trials and industrial sponsored trials steadily increased from year 2007 to year 2009. The web-based NMRR is the first research register in the world that links research proposal registration to ethical review and research grant application. Its future plan is to be linked with publication. Therefore, it is indeed an innovation that Malaysians should be proud of.
    Matched MeSH terms: Clinical Trials as Topic*
  16. Fulltext Patient registries in Malaysia and the role of the Clinical Research Centre of the Ministry of Health
    Pillay MS, Noor Hisham A, Zaki Morad MZ, Lim TO, Jamaiyah H, Jaya Purany SP
    Med J Malaysia, 2008 Sep;63 Suppl C:1-4.
    PMID: 19227669
    Matched MeSH terms: Clinical Trials as Topic*
  17. Fulltext Patient registries supplement. Foreword
    Abdul Hamid M
    Med J Malaysia, 2008 Sep;63 Suppl C:vii.
    PMID: 19227668
    Matched MeSH terms: Clinical Trials as Topic*
  18. Fulltext Psychological stress and treatment--research issues
    Azhar MZ
    Med J Malaysia, 2004 Jun;59(2):143-5.
    PMID: 15559161
    Matched MeSH terms: Clinical Trials as Topic*
  19. Fulltext ALLHAT in perspective: implications to clinical practice and clinical trials
    Yusoff K
    Med J Malaysia, 2005 Jun;60(2):239-45.
    PMID: 16114170
    ALLHAT study is the biggest randomized clinical trial in hypertension ever conducted. Its objective was to ompare the efficacy of newer (calcium channel blocker amlodipine and angiotensin-converting enzyme inhibitor inopril) to the older (diuretic chlorthalidone) antihypertensive agents in the treatment of patients with hypertension. After enrolling 42,000 patients who were followed for an average of 4.9 years, ALLHAT did not find significant differences in the primary end-points between these antihypertenive agents. ALLHAT however found significant differences in the secondary end-points such as heart failure and strokes between chlorthalidone and amlodipine or lisinopril. Based on these and on economic reasons, the investigators unequivocally recommended diuretics as the first line therapy for hypertension. Since its publication, ALLHAT has been much discussed, debated A and opined. The choice of drugs for study, the study design, the conduct of the study and the conclusions drawn by the investigators had all been criticised or controversial. Yet ALLHAT has been widely quoted, commented upon or referred to and it has been instrumental in initiating the JNC VII Guidelines. Thus a thorough understanding of ALLHAT is necessary for clinical practice and in designing and evaluating clinical trials in the future. Moving Points: in Medicine will capture the essence of ALLHAT, discusses its implications to clinical trials and explores its possible impact on the practice of medicine in this country.
    Matched MeSH terms: Clinical Trials as Topic
  20. Autoimmune hepatitis
    Sharmila S
    Med J Malaysia, 2005 Jul;60 Suppl B:136-7.
    PMID: 16108195
    Matched MeSH terms: Clinical Trials as Topic
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