There are about 3709 clinical studies being (or have been) conducted in Thailand. 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.
This is a Phase 2a study to evaluate the safety and pharmacokinetics (PK) of luspatercept in pediatric participants with β-thalassemia. The study will be conducted in 2 parts for both transfusion-dependent (TD) and non-transfusion-dependent (NTD) β-thalassemia participants: TD Part A will be in adolescent participants aged 12 to <18 years with two dose escalation cohorts, followed by a dose expansion cohort. NTD Part A will be conducted in the same age group participants as TD Part A with dose confirmation and expansion phase. After Part A TD participants have completed at least one year of treatment, all available safety data from Part A adolescent participants will be evaluated before initiating TD and NTD Part B in the age group from 6 to <12 years old. Part B will consist of two dose escalation cohorts for TD and two dose escalation cohorts for NTD. Upon completion of the Treatment Period, participants of any cohort who are benefiting from the study treatment, will be offered the opportunity to continue luspatercept treatment in the Long-term Treatment Period for up to 5 years from their first dose. Participants who discontinue study treatment at any time will continue in the Posttreatment Follow-up Period for at least 5 years from their first dose of luspatercept, or 3 years from their last dose, whichever occurs later, or until they withdraw consent/assent, are lost to follow-up, or the End of Trial, whichever occurs first.
The purpose was to evaluate the efficacy and safety of the combination of capmatinib with pembrolizumab compared to pembrolizumab alone as first-line treatment for subjects with locally advanced or metastatic NSCLC who have PD-L1 expression ≥ 50% and have no EGFR mutation or ALK rearrangement. Capmatinib has demonstrated immunomodulatory activities when combined with an anti-PD1 antibody in preclinical tumor models irrespective of MET dysregulation. The combination of capmatinib with checkpoint inhibitors has been established to be tolerable and could provide additional clinical benefit to the subjects.
This study aims to show that giving high dose, intravenous vitamin C in addition to standard care to burned critically ill patients will be associated with less organ dysfunction, improved survival and a quicker rate of recovery. In this study, all patients will receive standard care and of the patients will also receive high dose intravenous vitamin C, while the other half of patients will receive placebo.
Colonoscopy is the current standard method for examination of the colon. Bowel cleansing prior to colonoscopy is the essential prerequisite to ensure complete mucosal visualization and lesion identification.(1,2) Suboptimal preparations are associated with missed diagnoses, longer procedure times and increased costs related to the repeat procedures and shortened intervals between procedures.(3-5) Inadequate preparations have been noted in around 25 % cases in the US.(4,6) This has been attributed primarily to poor patient tolerance to the standard colon preparations. Osmotically balanced polyethylene glycol (PEG) electrolyte bowel lavage solutions were introduced in 1980.(7) These PEG based solutions are the most commonly used bowel preparations today.(7) They have high efficacy, are safe and are associated with minimal fluid and electrolyte imbalance. However the major drawback of these preparations is the taste and the large volumes required with associated nausea, cramping and vomiting.(8) This often results in poor compliance and tolerance with resultant poor preparation and improper visualization. A pooled analysis of 15 trials found that at least 29 % of patients were unable to complete their PEG solution.(9) Lubiprostone (LB) is a locally acting selective Type 2 chloride channel activator which causes intestinal fluid secretion. This results in increased softened stool and increased intestinal transit without the loss of either net intravascular fluid or electrolytes.(10) Peak plasma levels occur approximately 1.14 h after oral administration of a single 24 microgram dose, and the half-life of lubiprostone (t½) has been estimated at approximately 3 h.(11,12) LB is currently approved for the treatment of chronic idiopathic constipation and is generally well tolerated with an excellent side effect profile. Even long term usage has not shown clinically significant changes in electrolyte levels.(10,13) Our hypothesis was that administration of LB in addition to low volume (2-L) split-dose PEG would improve the adequacy of the bowel preparation as comparable as standard 4-L split-dose PEG regimens. Additionally, it could improve patient tolerability and decreased side effects related to the large volume of PEG regimens. Accordingly, we conducted this prospective, single-blind, randomized controlled trial.
BIOFLOW-DAPT is a prospective, multi-center, international, two-arm randomized controlled clinical study. A total of 1'948 subjects will be randomized 1:1 to receive either Orsiro Mission or Resolute Onyx. After index procedure, all patients will receive DAPT (ASA + P2Y12 inhibitor) for 30 days, followed by monotherapy with either P2Y12 inhibitor or ASA only until the end of the study. Clinical follow-up visits will be scheduled at 1, 6 and 12 months post-procedure.
This investigation is designed to evaluate the performance rate of a polyurethane (PU) condom versus a standard natural rubber latex (NRL) condom.
The retrospective pre-post observational study was conducted to evaluate the real-world evidence of efficacy and tolerability of generic levetiracetam (oral tablet) which was switched from original levetiracetam (oral tablet) in patients with epilepsy at the national hospital for neurology and neurosurgery in Thailand. Epilepsy patients who received generic substitution to original levetiracetam at the same dose and had stable conditions of seizure were only included. In the period of 6 months, the investigators assessed the change of seizure frequency, the incidence of hospitalization due to breakthrough seizure, the incidence of adverse events and the incidence of composite outcomes related to dosage adjustment of antiepileptic drugs.
Iron deficiency anemia is a global health problem and the most common cause of anemia worldwide. Patients with iron deficiency and Iron deficiency anemia can present with a multitude of symptoms including fatigue, dyspnea on exertion, dysphagia, pallor, palpitations, headaches, tinnitus, taste disturbance and pica. Oral iron supplementation is associated with increasing hemoglobin in multiple studies in women, pregnant women and elderly patients. However, the optimal dose and frequency of oral iron supplementation for treatment remains unclear. The current proposed study attempts to address this gap in the literature.
Morbidly obese patients are at risk for diastolic cardiac dysfunction, which can lead to adverse event, such as, diastolic heart failure postoperatively. Preoperative screening by transthoracic echocardiogram is difficult due to anatomical challenge, therefore the prevalence of this problem may be underestimated. The investigator would like to perform transesophageal echocardiogram in this group of patients after anesthesia induction to demonstrate the true prevalence of this syndrome.
The primary objective of this study is: To demonstrate the Purified Vero Rabies Vaccine - Serum Free (VRVg-2) is non-inferior to Verorab and Imovax Rabies vaccines in each age group (pediatric and adult populations) when administered as a 3-dose pre-exposure prophylaxis (PrEP) regimen, in terms of proportion of participants achieving a rabies virus neutralizing antibody (RVNA) titer greater than or equal to (>=) 0.5 IU/mL at Day (D) 42, i.e., 14 days after the 3rd injection (for Primary Series Cohort 1). The secondary objectives of this study are: First 1-5 with hypotheses testing will be evaluated sequentially - only if the previous objective is achieved, will the next objective be tested. To demonstrate that: - the observed proportion of participants in the VRVg-2 (VRVg) group at D42 is at least 99% with a lower limit of the 95% confidence interval (CI) of at least 97% - VRVg is non-inferior (NI) to Verorab and Imovax Rabies vaccines (Imovax) in each age group at D28 - 2-dose VRVg at D28 is NI to 3-dose Imovax at D42 in each age group - the observed proportion of participants in the VRVg group at D28 is at least 99% with a lower limit of the 95% CI of at least 97% - 2-dose Imovax at D28 is NI to 3-dose Imovax at D42 in overall participants (Cohort 1) To describe: - the immune response induced by VRVg versus Verorab and Imovax at D28 and at D42 in all age groups - the immune response induced by VRVg at D14 after a booster dose of VRVg administered at Month (M) 12 (Cohort 1) and between M24 up to M36 (Cohort 2) - the persistence of immune response at M6,12,18, and pre-booster between M24 up to M36 post-primary series vaccination (Cohort 2) - safety profile of VRVg versus Verorab and Imovax in primary series and after a booster dose of VRVg.