View clinical trials related to Safety Issues.
Filter by:This study is to assess the safety and immunogenicity of Vi-DT vaccine in adults, adolescent, children and infants.
An open-label Phase 1 trial to evaluate the safety and tolerability of MVA-BN-Brachyury priming and FPV-Brachyury boost vaccines modified to express brachyury and T-cell costimulatory molecules in patients with a metastatic or unresectable locally advanced malignant solid tumor. Subjects will be given the following subcutaneous doses: two prime doses with MVA-BN-Brachyury and monthly boost doses with FPV-Brachyury for 6 months. The study will last approximately 104 weeks before starting long term follow up (FU).
LHRH-a is an important hormone treatment in breast cancer especially in high-risk hormone receptor-positive patients or hormone receptor-negative but needing ovarian function protecting. The climacteric symptoms caused by LHRH-a are often and prominent, which is a common clinical problem.
This study is to assess protectivity and safety of Quadrivalent Influenza Vaccine in Indonesian Population
Stromal vascular fraction (SVF) can be isolated from fat (adipose) tissue in an outpatient in-clinic procedure. Platelet rich plasma (PRP) can be isolated from peripheral blood. The SVF includes a variety of different cells and growth factors where the adipocyte (fat cell) population has been removed. The use of SVF in the clinic for a variety of indications is analyzed for incidences of safety and tolerability.
This is a single and multiple dose, parallel group study to assess safety and pharmacokinetics of oral HTL0018318 in healthy Japanese and Caucasian subjects.
This is a single-center, prospective, controlled, double-blind, randomized study. A total of 50 renal transplant recipients diagnosed with post-transplantation diabetes mellitus (PTDM) will be included more than 1 year after transplantation and randomized 1:1 to empagliflozin (Jardiance®) 10 mg or placebo once daily for 24 weeks. Patients with estimated glomerular filtration rate below 30 mL/min will be excluded. Oral glucose tolerance test, 72h continuous glucose monitoring (iPro™2), measurement of arterial stiffness, body composition (including visceral fat), 24h blood pressure and 24h urinary glucose excretion will be performed at baseline and after 24 weeks in addition to standard safety measurements. Two safety visits will be performed at week 8 and 16. All concomitant medication, diet and exercise will be kept stable during the study period. The objective of the present study is to answer whether empagliflozin safely and effectively improves glucose metabolism together with weight loss in renal transplant recipients with PTDM.
The benefits of renin angiotensin system (RAS) blockers and diuretics for blood pressure control are well-established in chronic kidney diseases (CKD) patients; however, these agents may become hazardous on "sick-days" that lead to volume depletion (dehydration), and increase the risk of kidney function loss and acute kidney injury (AKI). It is not known how frequent significant sick-days occur in CKD patients, or whether a patient self-managed Sick-Day Protocol (SDP) that temporarily holds RAS blocker, diuretics, or other high risk medication in an effort to preserve renal function, or prevent AKI. The purpose of the study is to asses if a SDP, monitored remotely with a weekly automated phone survey , can improve outcomes in CKD (such as slow renal function loss and AKI episodes) and reduce preventable service utilization versus usual care.
This study is to assess the safety of Vi-DT vaccine in adults and children.
To study the oral mucosal effects in adult smokers associated with the use of two Nicotine Lozenge formulations.