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 study is designed as an experimental trial which collect prospective data at Mahidol university. It aims to characterize the responses of Thai pediatric population,age 1 - 6 years, to oxycodone oral syrup and its metabolites (oxymorphone, noroxymorphone and noroxycodone) with specific respect to the pharmacogenomics (How drug affects patients). A total of 20 generally healthy, opioid-naive children, aged 1-6 years, scheduled as in-patient surgery for non-emergency surgery, non-gastrointestinal tract surgery are involved. The patients are divide into 2 groups (1) 10 patients in 12 months - 1.9 years, and (2) 10 patients in the 2 - 5.9 years age group. Every patient will receive inhalational or intravenous induction of anesthesia as decided by the anesthesia team on the day of surgery, as is routine clinical care. An intravenous cannula (IV) will be inserted in every patient as part of their routine clinical care. No additional intravenous line will be required for this study. As part of the study protocol, a blood sample (5 mL) will be taken from the IV and sent for genetic analysis. (However, in order to limit the amount of blood drawn from small babies, 3 ml will be drawn, not 5 ml, if the patient is less than 6 months or less than 10kg.) The genetic testing is specifically to analyze the following genotypes only: CYP2D6 and CYP3A4, which represent the differences in cytochrome P450 metabolism of oxycodone. An orogastric tube will be placed in the stomach under anesthesia as is part of standard routine clinical care to remove gastric contents. The same orogastric tube will be used for intragastric liquid oxycodone administration in a dose of 0.1 mg/kg before the surgical incision. This weight-adjusted dose of 0.1 mg/kg is administered as per standard clinical dosing guidelines. 10 blood samples (51mL/sample) will be taken from the IV and sent for drug-level analysis. A total of 11 blood samples will be drawn for the study. The first sample will be sent for genetic testing. The other 10 samples will be drawn at the following time points: 30 minutes, 1, 1.5, 2, 3, 4, 5, and 6 hours post-dose in every patient and the other 2 samples anytime between 6 and 24 hours post-dose . Oxycodone, oxymorphone, noroxymorphone and noroxycodone levels, at 10 time points, will be used to determine the individual responses to oxycodone. CYP2D6 genotype will be determined to identify the ultra-rapid metabolizers.
This study is designed to examine the incidence of postoperative nausea and vomiting during 24 hours after elective laparoscopic cholecystectomy in patients receiving preoperative intravenous fluid loading (group F), ondansetron (group O) and receiving neither fluid nor ondansetron or control group (group C).
Surgical site infection (SSI) is a serious operative complication that may be associated with any surgical procedures. It increases morbidity and mortality after cardiac surgery. Plasma concentration of prophylactic antibiotic, routinely cefazolin, is altered by effects of cardiopulmonary bypass. This study is conducted to measure the plasma concentrations of cefazolin to determine its adequacy in pediatric patients undergoing elective cardiac surgery with cardiopulmonary bypass including its correlation with the incidence of postoperative SSI.
This study was designed to find out the stain removal efficacy and also, to find out the operators and patients opinion when use or receive treatment with both air polishing powders.
Lupus Low Disease Activity State (LLDAS) study is an international, multi-centre prospective study, developed by the Asia Pacific Lupus Collaboration (APLC) to investigate whether the attainment of LLDAS is associated with improved outcomes in patients with Systemic Lupus Erythematosus (SLE). SLE, or lupus, is the archetypal multisystem autoimmune disease, with an estimated incidence of 5-50 cases per 100,000 people. Patients with SLE, usually young women, suffer a marked loss of life expectancy, and severe morbidity, due to a heterogeneous range of clinical manifestations caused by autoimmune-mediated inflammation of multiple organs. The most severe manifestations of SLE are the accrual of irreversible organ damage, especially renal and central nervous system (CNS) involvement. As there is no effective targeted monotherapy for SLE, patients also suffer severe toxicity from the use of glucocorticoids and broad-spectrum immunosuppressive therapies. Despite combination therapy with current drugs, many studies show that the majority of patients suffer inadequate disease control and inexorably accrue permanent organ damage over time. The diversity of clinical features of active SLE has made quantification of disease activity problematic. Although there are a number of published systems in use to measure SLE disease activity, there are widely acknowledged problems with these instruments. Published definitions of remission are so stringent that they are met by less than 5% of patients. This lead to the realisation that rather than lupus remission, a lupus low disease activity state target may be more feasible, and that patients with low disease activity are more homogeneous than patients with active disease. Thus, the development of a definition of lupus low disease activity, which is feasible and has face validity, escapes the complexity of attempts to quantify heterogeneous states of active disease. In this study, the investigators will prospectively collect longitudinal data on consecutive SLE patients at each centre to evaluate the LLDAS definition. Protection from organ damage accrual as the primary endpoint.
Phase III, prospective, randomized, parallel, double blind, placebo-controlled study to determine whether Teriparatide can accelerate bone healing in unstable intertrochanteric fracture patients treated with Proximal Femoral Nail Antirotation (PFNA) assessed by radiographic and clinical outcomes.
Elimination of P. falciparum (PF) malaria across a territory requires universal access to treatment of clinical cases for communities, and specific targeting of places or population groups where malaria transmission persists in spite of generalized access to treatment. In particular, a large prevalence of carriers of PF parasites is suspected to be one of the reasons for malaria persistence. The fact that these carriers are not developing symptoms allow them to harbour and transmit parasites over long periods of time. They are likely to contribute significantly the transmission in their community and even beyond it according to their movement patterns. Identifying these pockets of high asymptomatic carriage is a key component of the malaria elimination strategy, as it allows targeting specific interventions, such as targeted mass-treatment, to quickly drain the asymptomatic reservoir. Strategically to achieve this goal we need to be able to identify quickly and reliably the villages or groups of villages in which the asymptomatic reservoir is large and should be addressed by targeted mass drug administration (MDA). There are no point of care tests currently available to detect asymptomatic carriers accurately. The available Rapid Diagnostic Tests (normal RDT) are designed to diagnose clinically relevant malaria infections. However their sensitivity for asymptomatic malaria carriers is low, since most of these individuals harbor parasitaemias below RDT detection thresholds. Currently, we are relying on high volume blood surveys, in which a small sample of the village population provides a 2mL venous blood sample that can be analysed by ultra-sensitive qPCR. This technique allows detecting very low parasitaemias. However it is a high cost test and technical requirements to use qPCR limit the number of samples that can be tested. In addition as the analysis must be done in a laboratory, the time needed for shipment and analysis results in delays of 4 to 8 weeks between survey and result. Surveying remote, poorly resourced areas adds to the challenge as the samples must be shipped from the field to the laboratory, on cold chain, within 24 to 48h from blood draw. To ensure that asymptomatic individuals are diagnosed in a cost effect and feasible manner, it is vital that a more sensitive RDT is made available for use in the field. Depending on its performance, a sensitive RDT could be used for prevalence surveys to target MDA, or directly for interventions based on treatment of positive individuals (reactive case detection or mass screening and treatment). A new hypersensitive RDT (hsRDT) has now been developed but before it can be utilised for elimination surveys we need to validate both its technical properties (sensitivity and specificity) and its usefulness in the field to detect PfHRP2 presence compared to a gold standard control ELISA (Enzyme Linked Immuno-Sorbent Assay) test. This will allow confirmation of false- and true- positive among samples.
Transnasal transsphenoidal (TNTS) resection of pituitary tumors involves wide fluctuation in hemodynamic parameter and causes hypertension and tachycardia due to intense noxious stimuli during various stages of surgery. None of routinely used anesthetic agents effectively blunts the undesirable hemodynamic responses, and therefore usually there is a need to use increased doses of anesthetic agents. Dexmedetomidine (DEX) an α-2 adrenergic receptor agonist, because its sympatholytic and antinociceptive properties may ensure optimal intraoperative hemodynamic stability during critical moments of surgical manipulation. In addition, DEX reduced the anesthetic requirement with rapid recovery at the end of surgery. The main aim of the study was to evaluate the effect of DEX on perioperative hemodynamics, anesthetic requirements
Comparing the Efficacy of Ultrasound Guided Hyaluronic Injection with Ultrasound Guided Corticosteroid Injection in Treatment of Trigger Finger
This protocol for Varlitinib is developed for the treatment of Gastric Cancer. Varlitinib (also known as ASLAN001) is a small-molecule, adenosine triphosphate competitive inhibitor of the tyrosine kinases - epidermal growth factor receptor (EGFR), human epidermal growth factor receptor (HER)2, and HER4. Varlitinib may be beneficial to subjects with cancer by simultaneous inhibition of these receptors. The purpose of this study is to determine the safety and efficacy of Varlitinib in combination with mFOLFOX6 for the treatment of Gastric Cancer. Treatment groups are Varlitinib+mFOLFOX6 and Placebo+mFOLFOX6.