View clinical trials related to Safety Issues.
Filter by:The goal of this single-center, prospective clinical trial is to test the safety and efficacy of belimumab combined with multi-target therapy in the treatment of severe lupus nephritis. The main questions it aims to answer are: lupus nephritis complete remission rate at week 24, and the partial remission rate and safety assessments. Patients with severe lupus nephritis will be enrolled and received pulse methylprednisolone at a dose of 1.5 to 3.0g, followed by intravenous belimumab at a dose of 10mg per kilogram at weeks 2, 4, and 6, and every 4 weeks thereafter. Multitarget therapy will be also administered during the induction phase. Induction therapy will last for 24 weeks. Patients with severe lupus nephritis who only received multi-target therapy during the same period will be enrolled as the control group.
Currently, there are different strategies to prevent the effect of beverages and foods on blood glucose levels after ingestion. In this sense, polyphenols are a promising field; these compounds are secondary metabolites produced by plants, vegetables, and fruits; of these compounds, gallic acid, quercetin, and kaempferol stand out for their antihyperglycemic characteristics through a) complex formation, b) enzymatic inhibition, c) affecting transport and, d) stimulation of the secretion of intestinal satiety hormones. Vachellia farnesiana (VF) is a shrub distributed in arid, semi-arid, and tropical regions of Mexico and the world. The polyphenols of the fruits of VF in pre-clinical studies by this research group have shown important antioxidant activity and antihyperglycemic effects. The present proposal aims to evaluate the effect of the polyphenolic extract of Vachellia farnesiana on glycemic response and to monitor liver and renal function tests as a safety control in healthy volunteers through developing a Phase I clinical study.
The study to investigate the effectiveness and the current perception of safety checklists in Ukrainian hospitals.
This clinical trial aims to learn about the safety, tolerability, and pharmacokinetic properties of SB17170 and its active metabolite SB1703 in single and multiple oral administration in healthy adults. The main questions it aims to answer are the safety, tolerability, and PK characteristics of SB17170 in healthy adults.
This study aims to prove the efficacy and safety of low dose nivolumab (40mg as the lowest available presentation) in combination with AVD (adriamycin,vinblastine sulfate and dacarbazine) as frontline treatment for classic Hodgkin's lymphoma.
Patient safety is a priority for healthcare systems. In safe systems, patients would be saved from avoidable harm, both from their own conditions, and from the care and treatments provided to them. Amongst the highest risk clinical settings are Surgical, Perioperative, Acute and Critical carE services (SPACE). The Central London Patient Safety Research Collaborative is funded to deliver world-class research into improving the safety of SPACE services, within which the investigators will evaluate major service reorganisation, compare and investigate organisational safety and quality, and investigate the disparity in postoperative complications associated with socioeconomic factors.
This study will test the hypothesis intracoronary administration of OmniMSC-AMI (allogenic bone marrow-derived mesenchymal stem cells) just after finishing the primary percutaneous coronary intervention (PCI) in ST-segment elevation myocardial infarction (STEMI) patients without cardiogenic shock is safe and may provide benefit on improving left ventricular ejection fraction (LVEF) during clinical follow-up.
The goal of this four-part preclinical [I-II] and clinical [III-IV] trial is to compare, with randomised crossover study design [I-IV], a new medical airway device with standard procedure (biteblock or no device) for upper airway patency during sedation with intravenous propofol [I-IV]. - Page 1 of 9 [DRAFT] - The two main questions it aims to answer are if this new airway device is superior to standard procedure with respect to - maintenance of spontaneous ventilation [I] and upper airway volumes [II] at moderate and deep steady-state levels of sedation in healthy volunteer study participants, and - fewer and less lasting bedside signs of respiratory depression [III-IV], and less adjuvant use of manual airway support [III-IV] during procedural sedation (PS) according to standard of care(SOC) in study patients scheduled for colonoscopy or ureteral catheterisation under PS. Owing to the crossover study design used throughout the trial, there are no comparison groups of study participants [I-II] or study patients [III-IV].
This study will investigate the effectiveness of a modified product "safe breastfeeding pillow" in enhancing the comfort and safety of postpartum women during breastfeeding. The results of this study can be used as a reference to promote clinical practice and education on breastfeeding to prolong the duration of breastfeeding and to ensure the safety of newborns.
The European Food Safety Authority has approved many applications for UVB light treated foods (e.g. UVB-exposed button mushrooms) in the last years. The UVB light treatment is used to increase the vitamin D content in foods and improve the vitamin D status of subjects. However, UVB irradiation is accompanied by the formation of vitamin D photoisomers such as lumisterol and tachysterol. The current study aims to investigated whether these vitamin D photoisomers can enter the circulation and are metabolised in humans that consume UVB-treated mushrooms.