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.
Adherence to antiretroviral therapy (ART) and pre-exposure prophylaxis (PrEP) are critical to the success of HIV treatment and therapeutic prevention. No accurate, objective point-of-care test is available to monitor adherence to either ART or PrEP. The inability to accurately identify poorly adherent patients will lead to more HIV infections (from failed PrEP and non-suppressive ART), more drug-resistant virus (selected by failing ART), and unnecessary switching to costly second- or third-line ART (when first-line regimens with virologic efficacy but non-adherence are stopped inappropriately). To address this critical knowledge gap, the investigators have developed a novel point-of-care test to detect the presence of tenofovir—the most common drug in both ART and PrEP treatments worldwide—in fingerprick blood or urine as an objective measure of ART and PrEP adherence. Our central hypothesis is that the pharmacokinetics of tenofovir in blood and urine will support point-of-care tenofovir detection as an objective measure of adherence, and that our point-of-care tenofovir assay will have the ability to discriminate different drug adherence levels. The investigators will test our central hypotheses by pursuing the following two specific aims: (1) To assess our novel point-of-care tenofovir (TFV) assay in whole blood and urine specimens within a controlled pharmacokinetic study of HIV-negative adults receiving tenofovir disoproxil fumarate (TDF) with low, moderate, and perfect adherence; and (2) To validate our novel point-of-care tenofovir (TFV) assay on blood and urine specimens using an existing biorepository from a real-world clinical HIV prevention study. This work is innovative because it develops an entirely new category of rapid diagnostic testing for monitoring ART and PrEP adherence at the clinical point of care. Our rapid assay will help clinicians identify patients in need of more adherence counseling, which when implemented will prevent HIV acquisition, emergence of drug resistant virus, and unnecessary ART regimen switching—measures that will improve national HIV programs and help preserve the global supply of an effective HIV medication.
This clinical research study is being conducted by Spark Therapeutics, Inc. to determine the safety and efficacy of the factor VIII gene transfer treatment with SPK-8011 in individuals with hemophilia A.
The purpose of this study is to collect information about what happens when people pause, or temporarily stop taking, ART, and to collect blood samples from these people at frequent intervals. We will also study the safety of pausing ART under close observation.
The purpose of this study was to evaluate the efficacy and safety of eltrombopag in combination with cyclosporine alone as first-line therapy on overall hematologic response
Patellar crepitus is a complication of total knee arthroplasty (TKA).The development of patellar crepitus after TKA are related to many factors such as femoral component design, surgical errors, and postoperative patellar baja. However, it is unclear whether patella resurfacing or patella non-resurfacing are associate with patellar crepitus. The primary objective of this study are to compare the prevalence of patellar crepitus and the mean value of vibroacoustic signal between patellar-resurfacing and patellar non-resurfacing in TKA. The secondary objective is to study the association between patellar crepitus and vibroacoustic signal.
Mother-to-child transmission (MTCT) of hepatitis B virus (HBV) remains the major mode of transmission in most high and intermediate HBV endemic areas, despite existing WHO immunoprophylaxis recommendations. This immunoprophylaxis regimen, if given optimally, can prevent 75-80% of HBV MTCT, but optimal implementation is difficult because it requires administering monovalent HBV vaccine and hepatitis B immunoglobulin (HBIg) within 24 hours of birth. Due to the barriers of giving HBIg, the World Health Organization (WHO) states, "…owing to concerns related to supply, safety and cost, the use of HBIg is not feasible in most settings." Clearly, global control of HBV transmission will require improved MTCT prevention. Therefore, the investigators hypothesize that treating HBV early in pregnancy will lead to undetectable HBV DNA levels at delivery and prevention of MTCT of HBV without HBIg; a concept that has already been proven with HIV. Tenofovir disoproxil fumarate (TDF), an approved anti-HBV drug, is promising to prevent MTCT of HBV due to its high potency against hepatitis B and its safety record in pregnant women. A randomized, controlled clinical trial (RCT) will be necessary to determine if TDF given to HBV-infected pregnant women early in pregnancy plus vaccine to the newborn can decrease MTCT of HBV without HBIg. However, before embarking on a RCT, several critical knowledge gaps need to be addressed including the ideal timing for TDF initiation. The purpose of this proposal is to address these knowledge gaps.
Study to evaluate patient preference of deferasirox film-coated tablet (FCT) or deferasirox dispersible tablet (DT) in patient with transfusion - dependent thalassemia or non-transfusion -dependent thalassemia as measured by preference questionnaire at Week 48
Targeted malaria elimination (TME), which comprises appropriate case management by village health workers, vector control and mass drug administration, is currently being implemented through pilot projects in selected villages in the Greater Mekong Subregion (GMS) and the scale-up of the intervention to the regional level are underway. Based on mathematical modelling, extending the post-TME parasitaemia-free period in the majority of villagers for as short as 200 days will substantially increase the chances of achieving the interruption of malaria transmission. Immunogenicity of RTS,S is greater in older children, and the short term malaria protective effect is stronger than the overall effect assessed over 1-2 years. Addition of mass RTS,S/AS01E vaccination to the TME arsenal could provide this much needed additional protection. Currently there are no safety and immunogenicity data for the use of RTS,S/AS01 in Asian populations. This trial will generate the required data for the use of this vaccine in Asian populations. For integration with the current TME activities, which provide mass drug administrations at months M0, M1, and M2, it would be most efficient and practical to provide the vaccine at the same intervals. To address a two round intervention (M0, M2) where a three round intervention is not feasible, one study arm will look at the immune response generated by only two doses of vaccine and antimalarial medications. Recent evidence suggests that a vaccination schedule which includes a fractional dose of RTS,S/AS01 (1/5th of the standard dose) could be similarly or more protective than a schedule with three standard full doses, while requiring less vaccine and resources. The trial therefore includes study arms which will assess the safety and immunogenicity of fractional dose schedules. Each participant will be randomized into one of the following study arms in a ratio of 20:20:30:30:30:30:30, as follows: - RTS,S/AS01B Fractional dose group (Group 1) - Double RTS,S /AS01E Fractional dose group (Group 2) - RTS,S/AS01E Standard dose group (Group 3) - RTS,S/AS01E + DHA-PIP+PQ Standard dose group (Group 4) - RTS,S/AS01E Fractional dose group (Group 5) - RTS,S/AS01E + DHA-PIP+PQ Fractional dose group (Group 6) - RTS,S/AS01E + DHA-PIP+PQ Fractional two-dose group (Group 7)
Perioperative hypothermia is a common problem. It has been defined as a core temperature below 36ºC. The reasons why patient undergoing gynecologic laparoscopic surgery has perioperative hypothermia because the reduced metabolic heat production, redistribution of heat from the core to the periphery and impaired thermoregulation (due to anesthetics), use of cool carbon dioxide gas insufflations and surgical irrigation solution, as well as heat loss due to the cool environment. This perioperative problem has been linked to adverse patient outcomes such as myocardial ischemia as hypothermia increases plasma catecholamine, surgical site infection as hypothermia diminishes wound tissue O2 tension and coagulopathy as hypothermia impairs platelet function. It claims that perioperative heat loss occurs by radiation (60%), convection (25%) and evaporation (10%). This is caused by the difference between peripheral body and ambient temperature, air circulation around the body and vasodilatation. In daily practice, most anesthesia personnel warm patient peri-operatively by using force air warmer and intravenous fluid warmer. This study aimed to compare the difference of core and room temperature in patients undergoing gynecologic laparoscopic surgery by using forced air and intravenous fluid warmer
The purpose of this study is to determine efficacy of vaginal and oral progesterone after tocolytic therapy in threatened preterm labor