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.
The purpose of the study is to establish the efficacy, safety and tolerability of rosuvastatin in children and adolescents with homozygous familial hypercholesterolemia.
The purpose of this study was to collect safety and tolerability data on LCZ696 in eligible PARADIGM-HF patients who received open-label investigational drug. The parent PARADIGM-HF (NCT01035255) trial was terminated early due to compelling efficacy of LCZ696 in patients with heart failure with reduced ejection fraction (HFrEF) after the final pre-specified interim analysis in March 2014.
The purpose of this study is to assess the safety, efficacy, pharmacokinetics (PK), pharmacodynamics (PD), and immunogenicity of OMS721 in patients with thrombotic microangiopathies (TMA).
Primary aldosteronism (PA) is a disorder of the adrenal gland causing an autonomous overproduction of mineralocorticoids, leading to arterial hypertension. Although rare, it is the most frequent cause of secondary hypertension. Early detection is important to avoid end organ damage, specifically cardiovascular and metabolic morbidity. Recent studies showed a positive correlation between patients with PA with lower bone density especially at the spine, with significant improvement post treatment, either medically or surgically. There was also a positive correlation between high aldosterone renin ratio with higher levels of intact parathyroid hormone (iPTH) which is responsible for cortical bone loss especially at the distal forearm. We hypothesize that our patients with PA have a higher level of iPTH, with lower bone density especially at the distal forearm, with improvement post treatment.
In order to address and curb the high prevalence of childhood obesity in Malaysia, a school-based intervention program, MyBFF@school is developed for implementation in all schools in the country. The program is specific for overweight and obese students and it is hypothesized that by participating in this program, students will be able to control their body mass index.
Following the findings of the clinical trials in drug development, this global non-interventional cohort field study will investigate rivaroxaban under clinical practice conditions in comparison with current standard of care for patients with acute venous thoromboembolism (VTE). The main goal is to analyze long-term safety in the use of rivaroxaban in the treatment of acute VTE in routine clinical practice.
The study purpose is: - To assess the incidence of FVIII inhibitory antibodies during 6 months of twice weekly prophylactic treatment with BAX 855 or 50 exposure days (EDs), whichever occurs last. - To compare pharmacokinetic (PK) parameters to ADVATE. - To assess hemostatic efficacy in prophylaxis and the treatment of bleeding episodes. - To evaluate safety and immunogenicity.
The objectives of this single-arm, open-label trial are to assess the efficacy and safety of afatinib as second line treatment for patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) harbouring a common EGFR mutation who have failed first-line platinum-based chemotherapy and to demonstrate that the efficacy and safety are comparable to the results seen in previous trials.
Periodontitis, a bacterial dental biofilm based infectious disease, is a chronic inflammatory disease of the periodontium which results in irreversible destruction of supporting structures of the teeth such as periodontal ligaments, connective tissues, cementum and alveolar bone. More than 700 species of bacteria are estimated to be found in the sub-gingival dental biofilm in which periodontopathogens are found to be responsible in initiating periodontal disease. Chronic periodontitis, although termed as 'chronic', starts as an acute inflammation. Low levels of bacteremia and endotoxins provides a stimulus for the systemic inflammatory response. In periodontitis, the interaction of lipopolysaccharide (LPS) from gram-negative bacteria with host cells initiates the secretion of cytokines and the expression of cell adhesion molecules in gingival tissue which leads to loss of alveolar bone and connective tissues supporting the teeth. In the management of chronic periodontitis, non surgical periodontal therapy (NSPT) which includes oral hygiene instruction (OHI), scaling and root planing, is administered to improve clinical parameters as well as controlling the bacterial count responsible in initiating the disease and the resultant inflammatory response. Success of the treatment can be analyzed when the clinical parameters, counts of the microbes is reduced and inflammatory response is controlled. Studies which have evaluated the microbiological and immunological response following NSPT clearly demonstrates an improvement in clinical parameters, reduction in inflammatory mediators present as well as a decrease in microbial count. OHI which includes tooth brushing and inter-dental cleaning is found beneficial in removing microbial plaque, thus, preventing periodontal diseases such as gingivitis and periodontitis. Studies have evaluated the role of OHI on clinical and immunological parameters and microbiological profiles of periodontal maintenance subjects, while none of them evaluated its role alone in the management of chronic periodontitis subjects. Therefore, the purpose of the following investigation was to compare the changes in the clinical parameters, inflammatory mediators as well as level and frequency of detection of periodontopathogens that take place after 3-months of NSPT versus OHI and to evaluate if clinical parameters have an effect on these inflammatory mediators and microbiological changes.
This study evaluated change over time in neurocognitive testing in patients receiving statin therapy in combination with evolocumab (AMG 145), compared with patients receiving statin therapy in combination with placebo.