The Thai Surgical Intensive Care Study (Thai-SICU Study)
Complications of Surgical and Medical Care: General TermsAdverse Reaction to Drug2 moreThe study observed the 28 days mortality of 9 participated University base surgical intensive care unit (SICU) as well as the occurrence of adverse events in SICU.
Outcome of Patients Treated by iv Rt-PA for Cerebral Ischaemia According to the Ratio Sc-tPA/Tc-tPA...
StrokeAcute1 moreintravenous rt-PA is effective to reduce the risk of death or dependency after ischaemic stroke. This effect is due to an early recanalization secondary to the lysis of the clot. However this effect may be counterbalanced by the increased risk of bleeding and also the neurotoxicity of rt-PA, which has been shown in animals to depend on the ratio single chain (sc) / double chain (tc) in the rt-PA administered. The main objective of OPHELIE is to determine whether the functional outcome after treatment by iv rt-PA depends on the ratio sc-rtPA / tc-rtPA. Secondary objectives were to identify the influence on the risk of brain haemorrhage, and the influence of the cognitive state (OPHELIE-COG substudy).
Post-License Safety Evaluation of Influenza Virus Vaccine
InfluenzaAdverse Drug EventTo evaluate the safety of the post-licensed influenza virus vaccine made of Changchun Institute of Biological Products Co.,Ltd.
The Effect of Desflurane on Myocardial Function in Patients Undergoing Coronary Artery Bypass Grafting...
Coronary Artery Bypass Graft RedoGeneral Anesthetic Drug Adverse ReactionThis study is to assess the effect of desflurane on myocardial function in patents who underwent coronary artery bypass grafting.
Eliminating Risk of Preventable Adverse Drug Events at the Hospital-community Interface of Care...
Adverse Drug EventsThis initiative aims to decrease the risk of medication errors at the hospital-community interface as well as health system utilization following hospital discharge by implementing a pharmacist-led medication reconciliation in the patients' home within 72 hours of hospital discharge.
Immune CHeckpoint Inhibitors Monitoring of Adverse Drug ReAction
ArthritisCancer6 moreImmune checkpoint inhibitors (ICIs) might have high grade immune-related adverse events (irAEs) from rhumatologic, endocrinologic, cardiac or other system origin. This study investigates reports of drug induced irAEs with treatment including anti-PD1, Anti-PDL-1, and Anti-CTLA4 classes using the World Health Organization (WHO) database VigiBase and the french database Base Nationale de PharmacoVigilance (BNPV).
The Drug Induced Renal Injury Consortium
Acute Kidney InjuryAdverse Drug Reaction3 moreSome medications are known to cause kidney damage because the person is allergic to the medication while others cause direct damage to the kidney because they are toxic at certain concentrations. Risk factors for developing kidney damage have been identified for some medications but not for all. Patients who are exposed to these important medications and develop problems with their kidneys may have some genetic risk. The purpose of this study is to determine the genetic risk factors for drug induced kidney injury. A better understanding of the role of genetics for the development of kidney injury from medications will allow us to better select medications, improve effectiveness of treatment and minimize harm.
Adherence and Coagulation Assays in Dabigatran-treated Patients With Atrial Fibrillation
Atrial FibrillationMedication Adherence12 moreIn patients with non-valvular atrial fibrillation treated with dabigatran etexilate, the level of adherence will be measured using a questionnaire, the Danish National Prescription Registry and pillcount and will be related to plasma levels of dabigatran measured by liquid chromatography tandem mass spectrometry (LC-MS/MS) and coagulation assays. The aim of the study is to measure the level of adherence and evaluate the usefulness of different coagulation assays to measure adherence in these patients. Furthermore, the aim is to determine the correlation between the anticoagulant effect of dabigatran using different coagulation assays and plasma levels of dabigatran. Most studies so far have been performed in vitro with plasma samples spiked with dabigatran. In this study the present knowledge from results of coagulation assays in dabigatran spiked plasma samples will be compared to the results of coagulation assays using blood samples from real-life patients.
Monitoring the Hyperammonaemia:TOXicity of Drugs (AmmoTOX)
HyperammonemiaMetabolic Disease2 moreSeveral drugs and chemotherapies seem to have an impact on the metabolic system. This study investigates reports of metabolic toxicities such as hyperammonemia, including the International classification of disease ICD-10 for treatments in the World Health Organization (WHO) global Individual Case Safety Report (ICSR) database (VigiBase).
Chimeric Antigen Receptor T-cell and Cellular Therapies for the Treatment of cAncer or BLood Diseases:...
Adverse Drug ReactionsCancerCAR-T cells and cellular therapies may lead to various adverse reactions. This study investigates reports of different toxicities for cellular therapies in the World Health Organization's (WHO) global database of individual safety case reports (VigiBase).