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.
In a phase 1, open-label, crossover study to evaluate the relative bioavailability of a tablet formulation of ravidasvir (test) versus the capsule formulation of ravidasvir (reference) in 24 healthy adult volunteers (PPI-668-104 study), relatively high intra-subject coefficients of variation were observed for both Cmax and AUC0-t. A two-sequence, four-period replicate design will be used to allow the possibility to scale the acceptance range for Cmax if the observed intra-subject coefficient of variation for the reference formulation is greater than 30%
Addressing the increasing trend in diabetes and mental illness co-morbidities, Malaysia is currently in need of a self- management program that promotes patient empowerment and overall well-being - beyond education. Committing to the self-care behaviours is highly dependent on the individual's self-efficacy. Self-efficacy has been shown to have a direct positive relationship with self-care behaviours, direct negative relationship with psychological distress and depression. Self-efficacy has also been found to hold a mediating effect on the relationship between emotional distress and self-care behaviours. The objective of this study is to assess the effectiveness of a self-management program for patients with diabetes, the Optimal Health Program (OHP) in improving self-efficacy, depression, anxiety, diabetes distress, well-being and self-care. This study is a randomized controlled trial study of patients with diabetes attending the four diabetes health clinics within the Putrajaya District. Eligible patients will be randomly allocated to either treatment as usual (TAU) or OHP and treatment as usual (OHP + TAU). The treatment as usual group (TAU) participants will be invited to participate in the OHP at the end of the study. The participants in the OHP + TAU will attend 5 weekly 1.5 hour sessions and a booster session at 3 months. Following ethics approval, recruitment and training will commence in September, data collection expected to be until April 2020. It is hypothesized that the OHP + TAU group will have higher self-efficacy, well-being and self-care scores and reduced depression, anxiety, diabetes related-distress and HbA1c. This study will contribute towards the gap in the literature in the effectiveness of a self-efficacy enhancing psychosocial self-management program among diabetes patients in Malaysia within a primary care setting.
To prospectively collect whole blood specimens and clinical data from pregnant women scheduled for an invasive prenatal diagnostic procedure ("invasive procedure"). Specimens will be used for future testing with an investigational NIPT.
Spinal biopsy is important to obtain culture and histopathological diagnosis in spine infection and tumors. To date, there is no prospective randomized study comparing both techniques. Therefore, the aim of this prospective randomized trial was to evaluate the accuracy, safety and diagnostic outcome of both these techniques.A prospective randomized trial was performed in 60 patients divided equally into fluoroscopic and CT guided spinal biopsy groups. Transpedicular approach was done with 8G core biopsy needle. Specimens were sent for histopathological examinations and cultures. Diagnosis were made based on biopsy results, clinical criteria and disease progression during 6 months follow up. Radiation expose to patients and doctors were measured with optically stimulated luminescence dosimeters (OSLDs).
The purpose of this study was to establish safety and efficacy of ligelizumab in adolescent and adult subjects with Chronic Spontaneous Urticaria (CSU) who remain symptomatic despite standard of care treatment by demonstrating better efficacy over omalizumab and over placebo. The study population consisted of 1,072 male and female subjects aged ≥ 12 years who were diagnosed with CSU and who remained symptomatic despite the use of H1-antihistamines. This was a multi-center, randomized, double-blind, active- and placebo-controlled, parallel-group study. There was a screening period of up to 28 days, a 52 week double-blind treatment period, and a 12 week post-treatment follow-up period.
The researchers are doing the study to see if semaglutide may reduce the risk of having cardiovascular events in patients with overweight or obesity and with prior cardiovascular disease. The participant will either get semaglutide (active medicine) or placebo ("dummy" medicine). Which treatment the participants get is decided by chance. The participant's chance of getting semaglutide or placebo is the same. The participant will get the study medicine in a pen. The participants will need to use the pen to inject the study medicine in a skinfold once a week. The study will last for about 2.5 to 5 years. Participants will have up to 25 clinic visits with the study doctor.
1) To evaluate the efficacy and safety of cariprazine at a target dose of 3.0 mg/day compared with placebo in prevention of relapse in patients with bipolar I disorder whose current episode (i.e. index episode) is manic or depressive, with or without mixed features; 2) To evaluate the efficacy and safety of cariprazine at a target dose of 1.5 mg/day compared with placebo in prevention of relapse in patients with bipolar I disorder whose current episode (i.e. index episode) is manic or depressive, with or without mixed features who were initially stabilized on a target dose of 3.0 mg/day
Background: The exit strategy after ureteroscopy for stone treatment remains a topic for discussion. Current EAU guidelines on urolithiasis state that postoperative stenting is indicated in patients at increased risk of postoperative complications. Stenting is not considered necessary in all other cases, and after uncomplicated procedures. Objective: To analyse the postoperative ureteral stenting strategy in clinical practice looking at the indication, type of stents used and the duration of stenting after ureteroscopy for stone treatment. Furthermore, the investigators will examine in what setting the stents are being removed postoperatively. Study design: This study is a prospective, observational, international, multicentre registry study executed by uCARE. Study population: All patients >18 years with a ureter or renal stone who are planned for ureteroscopic treatment by semi-rigid and/or flexible ureteroscopy are eligible for this study.
This study will assess the safety and efficacy of repetitive transcranial magnetic stimulation (rTMS) as new preventive treatment of migraine.
Primary Objective: To characterize the frequency of bleeding episodes (BE) while receiving fitusiran treatment, relative to the frequency of bleeding episodes while receiving factor concentrate or bypassing agent (BPA) prophylaxis. Secondary Objectives: - To characterize the following while receiving fitusiran treatment, relative to receiving factor or BPA prophylaxis: - the frequency of spontaneous bleeding episodes - the frequency of joint bleeding episodes - health related quality of life (HRQOL) in participants greater than or equal to (>=) 17 years of age - To characterize the frequency of bleeding episodes during the onset and treatment periods in participants receiving fitusiran. - To characterize the safety and tolerability of fitusiran. - To characterize the annualized weight-adjusted consumption of factor/BPA while receiving fitusiran treatment, relative to receiving factor or BPA prophylaxis.