There are about 2118 clinical studies being (or have been) conducted in Malaysia. The country of the clinical trial is determined by the location of where the clinical research is being studied. Most studies are often held in multiple locations & countries.
Our previous study has found that oil palm phenolics (OPP) supplementation at 9 grams per day is safe for consumption. An interesting observation was reported where the consumption of OPP showed significantly lower total and LDL cholesterol compared to the control group. There is no clinical evidence as yet on the optimum dosage of OPP supplementation in improving fasting lipid profile. We hypothesize that in a clinical study, OPP supplemented participants will elicit a reduction in total and LDL cholesterol while maintaining safety and tolerability.
This study is a phase 1, open label, randomized, three-way crossover, single dose, oral- administration of Andrographis paniculata and Metformin in healthy volunteers under fasting condition. The study will demonstrate the pharmacokinetics profile and pharmacodynamic through metabolic pathway analysis for Andrographis paniculata and Metformin.
There is currently no effective treatment in ALS. Oxidative stress, probably interacting with other neurodegenerative processes, is hypothesized to play a leading role in pathogenesis. These include mechanisms that promote glutamate excitotoxicity, mitochondrial dysfunction and axonal dysfunction. In a transgenic mouse model of fALS that develops a disease with a clinical phenotype similar to ALS, dietary vitamin E supplementation delayed disease onset and slowed progression, although it did not prolong survival. When used as an experimental therapy in human trials, vitamin E did not affect survival significantly, but possibly slowed ALS progression. Two large, prospective epidemiologic studies suggest that longterm use of vitamin E supplements could be inversely associated with risk of ALS or ALS death. In another study, higher baseline serum α-tocopherol was associated with lower subsequent risk of ALS. A modest, non-significant protective effect from supplementation was seen in subjects with baseline serum α-tocopherol levels below median levels. In the current study, we aim to investigate the effects of tocotrienols in patients with ALS, particularly in delaying disease progression as well as assessing its safety profile in this group of patients.
Suprascapular nerve block versus(vs) intra-articular steroid injection in the management of hemiplegic shoulder pain (HSP): a randomised, double blinded, controlled trial BACKGROUND Hemiplegic shoulder pain (HSP) is a common complication of stroke. It can happen as early as one week post stroke with a frequency as high as 72%. HSP can result in significant disability as pain and limited shoulder range of motion (ROM) decrease hand function, reduce participation in rehabilitation activity and delay functional recovery of the patients. Management of HSP focused on reducing pain and improving shoulder ROM. Minimally invasive treatment of HSP with intra-articular shoulder steroid (IAS) injection and supra-scapular nerve block (SSNB) have gained interest. OBJECTIVES Primary objective: 1. To assess the analgesic effect of SSNB vs IAS in HSP among Malaysian stroke population. Secondary objectives: 2. To assess the improvement of passive ROM post SSNB versus IAS in HSP. 3. To assess for improvement of functional outcome post SSNB versus IAS in HSP. METHOD A prospective, double blinded interventional study will be conducted in the Rehabilitation Medicine Clinic, University of Malaya Medical Centre for a duration of 1 year. Eligible subjects will be enrolled from all referrals of hemiplegic shoulder pain (HSP), following computer-generated randomization they will be allocated to either supra-scapular nerve block (SSNB) (intervention) or intra-articular shoulder steroid injection (IAS) (control) groups. The subjects and assessors are blinded to the intervention received, which will be performed by an experienced interventionist, not participating in randomization or data collection and analysis. Demographics of participants time since stroke, etiology, presence of spasticity, Numerical Rating Score (NRS) pain score at maximal passive ROM, maximum passive ROM of shoulder flexion, abduction, internal and external rotation as well as SDQ and SPADI will recorded prior to injection, 1 hour, 1 month and 3 months post injection. Mann-Whitney U tests and Chi-Square test of association will be used as appropriate to compare groups at baseline. Shoulder ROM and NRS pre and post intervention will be analysed using paired t-test and ANOVA. Functional outcome of SDQ and SPADI pre and post intervention will be analysed using paired t-test as well.
The main purpose of this study is to evaluate the efficacy and safety of M281 in participants with warm autoimmune hemolytic anemia (wAIHA).
Intraocular pressure (IOP) is the most important modifiable risk factor to prevent and delay progression of glaucoma. IOP reduction has been proven to delay the onset and progression of glaucoma, and uncontrolled IOP is constantly associated with progression of visual field loss. Medical therapy is the first line in IOP reduction for Primary Open Angle Glaucoma (POAG). It is a known fact that glaucoma patients often require addition of a second antiglaucoma medications when disease progresses or tachyphylaxis occurs. It was reported that more than 50% of patients require 2 or more medications to achieve optimum IOP control. Nevertheless, compliance and adherence are often impaired with multiple-drug therapy. Combining two ocular hypotensive agents in one bottle may help patients adhere to therapeutic regimen by reducing the number of medications used and the total number of doses administered.
The investigators plan to understand a comprehensive molecular profiling via the plasma, with the primary aim of using this form on analysis to guide subsequent treatment selection. This study will provide a better understanding of ALK resistance in the treatment of Asian lung cancers and allow for improved clinical outcomes by 'matching' the secondary mutations to an ALK inhibitor which would allow for the greatest coverage ultimately leading to lasting duration of response.
Obstructive sleep apnea (OSA) is a complex disease associated with repeated closure of the upper airway during sleep which causes excessive daytime sleepiness. Daytime sleepiness can affects daytime performance undesirably and reduces driving performance causing an increased risk for accidents. It can also lead to high blood pressure, strokes, and eventually death. Until now, there is no standardize value for the jaw advancement for the mandibular advancement appliance. It was found that when comparing the jaw advancement amount of 50% and above 50%, there is no additional efficacy. Efficacy of jaw advancement below 50% is lacking. Patients usually experience more complications with more advancement, there the investigators need to study the optimal mandibular advancement with least complication to the patients.
Fatty liver has been associated with high risk of progression to inflammation of the liver, liver cirrhosis (hardening of the liver), and eventually can lead to liver cancer. So far, the treatment for this condition involves controlling the cholesterol level in the body by practicing low fat diet and daily exercise. However, recently there has been evidence that alteration of the normal population of various types of bacteria that lives in the intestines may contributes to the development of fatty liver. Probiotics is a dietary supplement containing live bacteria that is formulated to change the composition and population of the bacteria in the intestines. It is postulated that by taking specifically formulated probiotics, the alteration of the intestinal bacteria may lead to improvement of the fatty liver, leading to better daily liver function. In this 6-month study, investigators would like to investigate the effectiveness of the probiotics in improving the liver function and in the treatment of the fatty liver. It will compare the fatty liver of patients who took the probiotics supplements compared to those who did not took it and see if there is any improvement.
A Phase 3b, open-label, single-arm, rollover study to evaluate the long-term safety of luspatercept, to the following participants: - Participants receiving luspatercept on a parent protocol at the time of their transition to the rollover study, who tolerate the protocol-prescribed regimen in the parent trial and, in the opinion of the investigator, may derive clinical benefit from continuing treatment with luspatercept - Participants in the follow-up phase previously treated with luspatercept or placebo in the parent protocol will continue into long-term post-treatment follow-up in the rollover study until the follow-up commitments are met - The study design is divided into the Transition Phase, Treatment Phase and Follow-up Phase. Participants will enter transition phase and depending on their background will enter either the treatment phase or the Long-term Post-treatment Follow-up (LTPTFU) phase - Transition Phase is defined as one Enrollment visit - Treatment Phase: For participants in luspatercept treatment the dose and schedule of luspatercept in this study will be the same as the last dose and schedule in the parent luspatercept study. This does not apply to participants that are in long-term follow-up from the parent protocol - Follow-up Phase includes: - 42 Day Safety Follow-up Visit - During the Safety Follow up, the participants will be followed for 42 days after the last dose of luspatercept, for the assessment of safety-related parameters and adverse event (AE) reporting - Long-term Post-treatment Follow-up (LTPTFU) Phase - Participants will be followed for overall survival every 6 months for at least 5 years from first dose of luspatercept in the parent protocol, or 3 years of post-treatment from last dose, whichever occurs later, or until death, withdrawal of consent, study termination, or until a subject is lost to follow-up. Participants will also be monitored for progression to AML or any malignancies/pre-malignancies. New anticancer or disease related therapies should be collected at the same time schedule Participants transitioning from a parent luspatercept study in post-treatment follow-up (safety or LTPTFU) will continue from the same equivalent point in this rollover study. The rollover study will be terminated, and relevant participants will discontinue from the study when all participants fulfill at least 5 years from the first dose of luspatercept in the parent protocol, or 3 years of post-treatment from last dose, whichever occurs later.