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Fulltext The promising future of chia, Salvia hispanica L

Mohd Ali N, Yeap SK, Ho WY, Beh BK, Tan SW, Tan SG

J Biomed Biotechnol, 2012;2012:171956.
PMID: 23251075 DOI: 10.1155/2012/171956

With increasing public health awareness worldwide, demand for functional food with multiple health benefits has also increased. The use of medicinal food from folk medicine to prevent diseases such as diabetes, obesity, and cardiovascular problems is now gaining momentum among the public. Seed from Salvia hispanica L. or more commonly known as chia is a traditional food in central and southern America. Currently, it is widely consumed for various health benefits especially in maintaining healthy serum lipid level. This effect is contributed by the presence of phenolic acid and omega 3/6 oil in the chia seed. Although the presence of active ingredients in chia seed warrants its health benefits, however, the safety and efficacy of this medicinal food or natural product need to be validated by scientific research. In vivo and clinical studies on the safety and efficacy of chia seed are still limited. This paper covers the up-to-date research on the identified active ingredients, methods for oil extraction, and in vivo and human trials on the health benefit of chia seed, and its current market potential.

Matched MeSH terms: Clinical Trials as Topic
"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
Fulltext Quality of adverse event reporting in clinical trials of remdesivir in patients with COVID-19

Kow CS, Aldeyab M, Hasan SS

Eur J Clin Pharmacol, 2021 Mar;77(3):435-437.
PMID: 33011825 DOI: 10.1007/s00228-020-03008-6
Matched MeSH terms: Clinical Trials as Topic/standards*
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*
Identifying critically important vascular access outcomes for trials in haemodialysis: an international survey with patients, caregivers and health professionals

Viecelli AK, Howell M, Tong A, Teixeira-Pinto A, O'Lone E, Ju A, et al.

Nephrol Dial Transplant, 2020 04 01;35(4):657-668.
PMID: 31369099 DOI: 10.1093/ndt/gfz148

BACKGROUND: Vascular access outcomes reported across haemodialysis (HD) trials are numerous, heterogeneous and not always relevant to patients and clinicians. This study aimed to identify critically important vascular access outcomes.
METHOD: Outcomes derived from a systematic review, multi-disciplinary expert panel and patient input were included in a multilanguage online survey. Participants rated the absolute importance of outcomes using a 9-point Likert scale (7-9 being critically important). The relative importance was determined by a best-worst scale using multinomial logistic regression. Open text responses were analysed thematically.
RESULTS: The survey was completed by 873 participants [224 (26%) patients/caregivers and 649 (74%) health professionals] from 58 countries. Vascular access function was considered the most important outcome (mean score 7.8 for patients and caregivers/8.5 for health professionals, with 85%/95% rating it critically important, and top ranked on best-worst scale), followed by infection (mean 7.4/8.2, 79%/92% rating it critically important, second rank on best-worst scale). Health professionals rated all outcomes of equal or higher importance than patients/caregivers, except for aneurysms. We identified six themes: necessity for HD, applicability across vascular access types, frequency and severity of debilitation, minimizing the risk of hospitalization and death, optimizing technical competence and adherence to best practice and direct impact on appearance and lifestyle.
CONCLUSIONS: Vascular access function was the most critically important outcome among patients/caregivers and health professionals. Consistent reporting of this outcome across trials in HD will strengthen their value in supporting vascular access practice and shared decision making in patients requiring HD.

Matched MeSH terms: Clinical Trials as Topic/standards*
Fibrinolytic response in women on low-dose oral contraceptive

Ishak R, Ahmad R, Gudum HR, Hassan K, Ang ES

Malays J Reprod Health, 1992 Jun;10(1):7-11.
PMID: 12345026

PIP: Long term use of low doses of combination oral contraceptives appears to increase plasminogen level, thereby increasing fibrinolytic activity and reducing the risk of thromboembolism. Blood levels of plasminogen, tissue plasminogen activator (tPA), and plasminogen activator inhibitor (PAI), were measured before and after stress (5 minutes of stair climbing) in a group of 30 women, 23-40 years old, who had taken 30 mcg of ethinyl estradiol with 150 mcg of desogestrel or levonorgestrel for at least 1 year. Similar measurements were taken from a control group of 30 women matched for age, height, and weight. Plasminogen and tPA levels in both groups increased significantly after exercise. The level of PAI did not change significantly with stress in either group. The level of plasminogen was significantly higher in the group taking contraceptives, whether before or after exercise, when compared to the control group. Levels of tPA and PAI, although slightly increased in the oral contraceptive group, were not significantly different between the two groups. The increase in plasminogen may be due to the estrogen component of the contraceptives. Stress seems to increase fibrinolytic response.

Matched MeSH terms: Clinical Trials as Topic*
Fulltext Retention in clinical trials after prison release: results from a clinical trial with incarcerated men with HIV and opioid dependence in Malaysia

Chandra DK, Bazazi AR, Nahaboo Solim MA, Kamarulzaman A, Altice FL, Culbert GJ

HIV Res Clin Pract, 2019 Feb;20(1):12-23.
PMID: 31303149 DOI: 10.1080/15284336.2019.1603433

Background: Study retention is a major challenge in HIV clinical trials conducted with persons recruited from correctional facilities. Objective: To examine study retention in a trial of within-prison methadone initiation and a behavioral intervention among incarcerated men with HIV and opioid dependence in Malaysia. Methods: In this 2x2 factorial trial, 296 incarcerated men with HIV and opioid dependence were allocated to (1) an HIV risk reduction intervention, the Holistic Health Recovery Program for Malaysia (HHRP-M), (2) pre-release methadone initiation, (3) both interventions, or (4) standard care (NCT02396979). Here we estimate effects of these interventions on linkage to the study after prison release and completion of post-release study visits. Results: Most participants (68.9%) completed at least one post-release study visit but few (18.6%) completed all 12. HHRP-M was associated with a 13.5% (95% confidence interval (CI): 3.8%, 23.2%) increased probability of completing at least one post-release study visit. Although not associated with initial linkage, methadone treatment was associated with an 11% (95% CI: 2.0%, 20.6%) increased probability of completing all twelve post-release study visits. Being subject to forced relocation outside Kuala Lumpur after prison release decreased retention by 43.3% (95% CI: -51.9%, -34.8%). Conclusion: Retaining study participants in HIV clinical trials following prison release is challenging and potentially related to the broader challenges that participants experience during community reentry. Researchers conducting clinical trials with this population may want to consider methadone and HHRP as means to improve post-release retention, even in clinical trials where these interventions are not being directly evaluated.

Matched MeSH terms: Clinical Trials as Topic*
Challenges in reducing dengue burden; diagnostics, control measures and vaccines

Lam SK

Expert Rev Vaccines, 2013 Sep;12(9):995-1010.
PMID: 24053394 DOI: 10.1586/14760584.2013.824712

Dengue is a major public health concern worldwide, with the number of infections increasing globally. The illness imposes the greatest economic and human burden on developing countries that have limited resources to deal with the scale of the problem. No cure for dengue exists; treatment is limited to rehydration therapy, and with vector control strategies proving to be relatively ineffective, a vaccine is an urgent priority. Despite the numerous challenges encountered in the development of a dengue vaccine, several vaccine candidates have shown promise in clinical development and it is believed that a vaccination program would be at least as cost-effective as current vector control programs. The lead candidate vaccine is a tetravalent, live attenuated, recombinant vaccine, which is currently in Phase III clinical trials. Vaccine introduction is a complex process that requires consideration and is discussed here. This review discusses the epidemiology, burden and pathogenesis of dengue, as well as the vaccine candidates currently in clinical development.

Matched MeSH terms: Clinical Trials as Topic
Nain-e Havandi Andrographis paniculata present yesterday, absent today: a plenary review on underutilized herb of Iran's pharmaceutical plants

Valdiani A, Kadir MA, Tan SG, Talei D, Abdullah MP, Nikzad S

Mol Biol Rep, 2012 May;39(5):5409-24.
PMID: 22198549 DOI: 10.1007/s11033-011-1341-x

Nain-e Havandi (Andrographis paniculata Nees.) (AP) is an annual herbaceous plant belonging to the family Acanthacea. Only a few species of Andrographis genus out of 28 are medicinally concerned of which AP is the most important. Knowledge about the arrival of AP to Iran is extremely lacking but most probably it has been imported from India. However, evidence implies the familiarity of Iran's folkloric medicine with this plant, but it has been disappeared from contemporary medicine for unknown reasons. Presence of active ingredients from diterpenoids group such as andrographolide, neoandrographolide and 14-deoxy-11,12-didehydroandrographolide has given incredible unique medicinal properties to the plant. Traditionally, Nain-e Havandi has been used in the role of a non-farm plant as a remedy for skin problems, flu, respiratory disease, and snakebite in East and Southeast Asia for centuries. Recently, it has been utilized as a treatment for HIV, hepatitis, diabetes, cancer and kidney disorders. Intensive cultivation of the herb started only in the past decade in countries such as China, India, Thailand, Indonesia, West Indies, Mauritius and to some extent, in Malaysia. Availability of different ecological zones in Iran complies with reestablishment of AP in tropical and temperate regions of the country. This is killing two birds with one stone, supporting the conservational and economic aspects.

Matched MeSH terms: Clinical Trials as Topic
Recent patents on topical application of honey in wound and burn management

Benhanifia MB, Boukraâ L, Hammoudi SM, Sulaiman SA, Manivannan L

Recent Pat Inflamm Allergy Drug Discov, 2011 Jan;5(1):81-6.
PMID: 21171951

Topical application of honey to burn and wounds has been found to be effective in controlling infection and producing a clean granulating bed. It is suggested that the wound healing effect of honey may in part be related to the release of inflammatory cytokines from surrounding tissue cells, mainly monocytes and macrophages. It has been reported that honey hastens wound healing by accelerating wound contractions. Microscopic evaluation demonstrated that there was a significant acceleration of dermal repair in wound treated with honey. Macroscopic and microscopic observations under in vivo assessment suggested that the topical application of honey might have favourable influences on the various phases of burn and wound healing hence accelerating the healing process. The regulatory effects of honey are related to components other than the sugars. However, the mechanisms by which honey affects the release of anti inflammatory agents and growth factors from monocytic cells are as yet unclear. Whether honey affects other cell types, particularly endothelial cells and fibroblasts, involved in wound healing also needs to be clarified. The present article is a short review of recent patents on the healing effect of honey in wound and burn management.

Matched MeSH terms: Clinical Trials as Topic
Development of enterovirus 71 vaccines

Lee MS, Chang LY

Expert Rev Vaccines, 2010 Feb;9(2):149-56.
PMID: 20109026 DOI: 10.1586/erv.09.152

Enterovirus 71 (EV71) was first isolated in 1969 in California, USA. Several epidemic outbreaks with high mortality rates have occurred in European and Asian Countries (Bulgaria in 1975, Hungary in 1978, Malaysia in 1997, Taiwan in 1998 and China in 2008). EV71 CNS involvement may be associated with neurological sequelae, delayed neurodevelopment and reduced cognitive functioning. Since poliovirus was nearly eradicated by vaccination, EV71 is now considered as one of the top candidates for new vaccine development against human enteroviruses. Recently, several EV71 vaccine candidates, including live-attenuated virus, inactivated whole virus, recombinant viral protein, virus-like particle and DNA vaccines, have been evaluated in animals but no clinical trial has yet been conducted. Based on historical experiences with poliovirus vaccines and animal studies, the inactivated whole-virus vaccines are feasible and could be licensed readily, so these are targeted for preparing clinical trials in several organizations in Asia.

Matched MeSH terms: Clinical Trials as Topic
Fulltext Breast cancer in malaysia: are our women getting the right message? 10 year-experience in a single institution in Malaysia

Taib NA, Yip CH, Ibrahim M, Ng CJ, Farizah H

Asian Pac J Cancer Prev, 2007 Jan-Mar;8(1):141-5.
PMID: 17477791

The message that health care providers caring for patients with breast cancer would like to put forth, is that, not only early detection is crucial but early treatment too is important in ensuring survival. This paper examines the pattern of presentation at a single institution over a 10-year period from 1995 to 2005. In Malaysia, education outreach programmes are ongoing, with contributions not only from the public sector, but also private enterprise. Articles on breast cancer in local newspapers and women magazines and television are quite commonplace. However are our women getting the right message? Now is an appropriate time to bring the stakeholders together to formulate a way to reach all women in Malaysia, not excluding the fact that we are from different races, different education levels and backgrounds requiring differing ways of delivering health promotion messages. To answer the question of why women present late, we prospectively studied 25 women who presented with locally advanced disease. A quantitative, quasi-qualitative study was embarked upon, as a prelude to a more detailed study. Reasons for presenting late were recorded. We also looked at the pattern of presentation of breast lumps in women to our breast clinic in UMMC and in the surgical clinic in Hospital Kota Bharu, in the smaller capital of the state of Kelantan, in 2003. There is hope for the future, the government being a socially responsible one is currently making efforts towards mammographic screening in Malaysia. However understanding of the disease, acceptance of medical treatment and providing resources is imperative to ensure that health behaviour exhibited by our women is not self-destructive but self-preserving. Women are an integral part of not only the nation's workforce but the lifeline of the family - hopefully in the next decade we will see great improvement in the survival of Malaysian women with breast cancer.

Matched MeSH terms: Clinical Trials as Topic
Fulltext Beta blockers in hypertension and cardiovascular disease

Ong HT

BMJ, 2007 May 5;334(7600):946-9.
PMID: 17478848
Matched MeSH terms: Clinical Trials as Topic
Pathogenesis and treatment of gastric carcinoma: "an up-date with brief review"

Khan FA, Shukla AN

J Cancer Res Ther, 2007 11 14;2(4):196-9.
PMID: 17998703

Gastric cancer is one of the most common cancers and most frequent causes of cancer-related deaths in the world. The overall survival rate is 15-20%. Although the incidence is declining, its prognosis remains poor. The etiological factors and pathogenesis of gastric cancer are not yet fully understood. The integrated research in molecular pathology clarified the details of genetic and epigenetic abnormalities of cancer-related genes in the course of development and progression of gastric cancer. Although epidemiological evidences indicate that environmental factors play a major role in the carcinogenesis, the role of immunological, genetic and immunogenetic factors are thought to contribute to etiopathogenesis of gastric carcinoma. In addition to better understanding of pathogenesis of gastric cancer, the incidence, diagnostic studies and the therapeutic options have also undergone important changes in the last decade. There is ongoing debate regarding the role of adjuvant treatment. In advanced disease, palliation of symptoms, rather than cure, is the primary goal of patient management. Several combination therapies have been developed and have been examined in phase III trials; however, in most cases, they have failed to demonstrate a survival advantage over the reference arm. This review summarizes the newer concepts of molecular biology on gastric carcinogenesis and the new important recommendations for the management of patient with gastric carcinoma.

Matched MeSH terms: Clinical Trials as Topic
Chemoprevention of colorectal cancer with nonsteroidal anti-inflammatory drugs

Hilmi I, Goh KL

Chin J Dig Dis, 2006;7(1):1-6.
PMID: 16412030 DOI: 10.1111/j.1443-9573.2006.00236.x

Colorectal carcinoma is one of the commonest solid organ tumors in the world and its prevalence appears to be increasing in Asia. Recently, there has been much interest in various chemotherapeutic agents for the management of this condition, in particular nonsteroidal anti-inflammatory drugs (NSAIDs). There is a large amount of data that suggest traditional NSAIDs, as well as the new cyclooxygenase (COX)-2 selective inhibitors such as rofecoxib and celecoxib, have a role in the setting of primary and secondary prevention, and adjuvant therapy of both sporadic colorectal carcinoma and familial adenomatous polyposis. This review examines some of this data, as well as the potential problems and limitations of using these agents, particularly in light of the recent withdrawal of rofecoxib.

Matched MeSH terms: Clinical Trials as Topic
Fulltext Patent foramen ovale and migraine: what is the relationship between the two?

Sathasivam S, Sathasivam S

J Cardiol, 2013 Apr;61(4):256-9.
PMID: 23484805 DOI: 10.1016/j.jjcc.2012.12.005

There is conflicting evidence on the causal relationship of patent foramen ovale (PFO) in migraine. This review will examine the pathophysiological relevance of PFO in migraine, the epidemiological evidence of PFO causing migraine, and the existing evidence on the effectiveness of closure of PFO on the symptomatology of migraine. From the current available evidence, the role of PFO in migraine is debatable, and interventions such as closure of PFO cannot yet be considered routine treatment of migraine.

Matched MeSH terms: Clinical Trials as Topic
Anti-inflammatory, antibacterial and analgesic potential of cocos nucifera linn.: a review

Dua K, Sheshala R, Ling TY, Hui Ling S, Gorajana A

Antiinflamm Antiallergy Agents Med Chem, 2013;12(2):158-64.
PMID: 23286236

At present, approximately 25%of drugs in modern pharmacopoeia are derived from plant sources (phytomedicines) that can be developed for the treatment of diseases and disorders. Many other drugs are synthetic analogues built on the prototype compounds isolated from plants. Cocos nucifera Linn. (Arecaceae), which is commonly known as coconut, is a plant possessing a lot of potential as an ingredient in traditional medicines for the treatment of metabolic disorders and particularly as an anti-inflammatory, antimicrobial and analgesic agent. This review emphasizes on the recent literature and research findings that highlight the significant biological activities of C. nucifera Linn. such as its anti-inflammatory, antimicrobial and analgesic properties. This review can help researchers keen on exploiting the therapeutic potential of C. nucifera Linn. which may motivate them to further explore their commercial viability.

Matched MeSH terms: Clinical Trials as Topic
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
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
The comparison between the different generations of autologous chondrocyte implantation with other treatment modalities: a systematic review of clinical trials

Samsudin EZ, Kamarul T

Knee Surg Sports Traumatol Arthrosc, 2016 Dec;24(12):3912-3926.
PMID: 26003481

PURPOSE: This paper aims to review the current evidence for autologous chondrocyte implantation (ACI) generations relative to other treatment modalities, different cell delivery methods and different cell source application.
METHODS: Literature search was performed to identify all level I and II studies reporting the clinical and structural outcome of any ACI generation in human knees using the following medical electronic databases: PubMed, EMBASE, Cochrane Library, CINAHL, SPORTDiscus and NICE healthcare database. The level of evidence, sample size calculation and risk of bias were determined for all included studies to enable quality assessment.
RESULTS: Twenty studies were included in the analysis, reporting on a total of 1094 patients. Of the 20 studies, 13 compared ACI with other treatment modalities, seven compared different ACI cell delivery methods, and one compared different cell source for implantation. Studies included were heterogeneous in baseline design, preventing meta-analysis. Data showed a trend towards similar outcomes when comparing ACI generations with other repair techniques and when comparing different cell delivery methods and cell source selection. Majority of the studies (80 %) were level II evidence, and overall the quality of studies can be rated as average to low, with the absence of power analysis in 65 % studies.
CONCLUSION: At present, there are insufficient data to conclude any superiority of ACI techniques. Considering its two-stage operation and cost, it may be appropriate to reserve ACI for patients with larger defects or those who have had inadequate response to other repair procedures until hard evidence enables specific clinical recommendations be made.
LEVEL OF EVIDENCE: II.

Matched MeSH terms: Clinical Trials as Topic

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