View clinical trials related to Safety.
Filter by:Phase 1, Single-Center, Dose-Escalating, Open-Label, Safety Clinical Trial of Parenteral Ascorbate-Meglumine as a Novel Magnetic Resonance Imaging (MRI)-guided Adjunctive Therapeutic for Stereotactic Radiosurgery (SRS)
This clinical trial aims to learn if Purified Exosome Product (PEP) is safe and tolerable when injected into the hypodermis of healthy adults. The main questions this study aims to answer are: Is PEP safe and tolerable when injected into the hypodermis of healthy adults? Are there signals of Collagen I/II and Elastin biostimulation? Subjects will serve as their own control and researchers will compare PEP to Control to see if PEP is safe.
This study seeks to determine the short-term effects of daily oral supplementation with a new micellar Glutathione formulation (LipoMicel) on the oral absorption and safety of glutathione in healthy volunteers. The primary objective of this study is to evaluate and compare the pharmacokinetics of a novel micellar Glutathione (GSH) formulation with that of a standard formulation as well as a liposomal GSH formulation. The secondary objective is to evaluate the safety of a new micellar GSH formulation with higher bioavailability in human participants over a 30-day study period.
This is an open, Phase I, investigator-initiated study (IIT) to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and efficacy of RD06-04 in patients with moderate or severe active SLE. This study will explore the safety of escalating doses of RD06-04 by presetting two dose levels (DL), with 3 to 6 patients enrolled in each dose level. After safety conclusions are reached in each group, the investigator can select the corresponding dose group to expand cases based on treatment response, but the total number of cases will not exceed 12. This study will enroll patients in a 3+3 design with two DLS: 1×105 CAR+T cells /kg for DL1 and 5×105 CAR+T cells /kg for DL2. Dose increment Refer to the 3+3 dose increment principle. Three subjects are expected to be enrolled in each dose group. 1. Dose increment should start from the minimum dose, and it is not possible to conduct an incremental study of 2 or more dose groups at the same time. 2. If 1 case of DLT occurs in each dose group, the dose level will be extended to 6 subjects. If 6 subjects at this dose level ≥2 subjects develop DLT, the dose level exceeds the MTD. The previous lower dose level will be extended to 6 subjects, and if 6 subjects have already been enrolled in the previous lower dose level, and only ≤1 of these 6 subjects develop DLT, this lower dose level will be considered MTD. 3. If DLT occurred in ≥2 subjects in the highest dose group, the researcher could select a dose between the high dose group and the medium dose group according to the specific situation and perform MTD evaluation. 4. If the dose increase to the highest dose group still does not reach DLT, researchers can explore the safety and efficacy of higher doses according to specific circumstances. Case expansion: After the completion of DLT evaluation in all dose groups, the investigators could select the corresponding dose group of extended cases according to the treatment response, but the total number of cases should not exceed 12 (extended cases were not evaluated by DLT).
This study objectively analyzes the safety and survival evaluation of perioperative immunotherapy combined with chemotherapy in locally advanced gastric cancer patients through a prospective randomized controlled trial research method; By comparing the pathological response rate, disease-free survival rate, and incidence of adverse events between the combination therapy and chemotherapy alone group, we aim to verify the efficacy and safety of tirelizumab combined with SOX/XELOX chemotherapy in disease control of locally advanced gastric cancer patients, laying the foundation and providing a basis for large-scale multicenter clinical research.
To evaluate the efficacy and safety of combined pars plana vitrectomy and planned foveal detachment through subretinal injection of ringer's solution in patients with non-tractional refractory diabetic macular edema.
This is a multicenter, open-label phase 1/2 study consisting of two parts: dose escalation phase and dose expansion phase. The objective of the dose escalation phase is to evaluate the safety, tolerability and pharmacokinetics of HYP-2090PTSA in patients with advanced solid tumors harboring KRAS mutation and to determine the RP2D. In the dose expansion phase, preliminary efficacy and safety at the RP2D will be further explored in patients with specific cancer harboring KRAS p.G12C mutation.
1. To evaluate the efficacy and safety of levosimendan and milrinone in the treatment of with acute heart failure with or without renal dysfunction; 2. Predictive modeling of the efficacy and safety of levosimendan and milrinone.
This research study is being conducted to find out how easy, comfortable, and safe intravaginal rings are for women to use. The two rings used in this study do not dispense any medications, are the same size, but differ in their flexibility and hardness. This study will enroll approximately 100 HIV-negative persons, aged18-45 years, and assigned female sex at birth from sites in the United States, South Africa, and Zimbabwe. Participants will be randomly assigned to use (self-insert) Ring A for 4 weeks and then Ring B for 4 weeks or Ring B first followed by Ring A. There will be a 1-3-week rest period between using the two different rings. The study involves answering questions, undergoing pelvic examinations, and collecting blood and vaginal fluid samples over a total of 7 in-person visits and 2 telephone calls over approximately 9-11 weeks. In addition, both participants and approximately 30 of their sexual partners will be asked to take part in in-depth interviews to further assess acceptability, attitudes, and experiences with ring use to gauge interest in the future use of intravaginal rings as a HIV prevention option.
This project intends to carry out a multi-center retrospective observational real-world study to understand the current status of amphotericin B use by formulation type, compare the differences in safety and efficacy of each formulation in domestic clinical application, provide real-world evidence for clinical drug selection, and provide evidence-based evidence in support of rational clinical drug use.