View clinical trials related to Safety.
Filter by:For patients with irresectable locally advanced non-small cell lung cancer (NSCLC) (e.g. multilevel or bulky N2 disease or presence of N3 lymph node metastases), current guidelines recommend treatment with chemoradiotherapy (CRT) followed by immune checkpoint inhibition (ICI, durvalumab). Chances of sterilization of a large (e.g. clinically staged T3 or T4 tumor) tumor volume by CRT alone are relatively small and these tumors are associated with a high local recurrence rate. Moreover, necrosis and cavitation of these tumors puts these patients at risk of fatal bleeding and might cause infectious complications, which lead to subsequent impaired quality of life (QoL) and to interruption of, or the need for postponing, (systemic) treatment. Upfront resection of the tumor in the lung, followed by postoperative CRT in patients who have a (potentially) resectable tumor could be a strategy to prevent complications of CRT in large volume and/or cavitating tumors with extensive mediastinal disease.
The nutrient composition of this product is similar to the existing Liquid IV "hydration multiplier" product already on the market but with the addition of amino acids. With such low quantities of amino acids, in particular as compared to the amounts consumed in normal diets, there is no reason to believe that the product would cause any adverse outcomes. However, since no research has been done on the safety of regular consumption of this product, this study will evaluate the safety of the product with regards to routing blood chemistries and other variables. Specifically, standard testing will be performed including a measurement of vital signs, comprehensive metabolic panel, hematology panel, urinalysis, and quantification of triiodothyronine, thyroxine, and thyroid stimulating hormone. A questionnaire will also be used to assess product tolerability.
Primary：Objectives ：SafetyTo describe the safetyprofile of all participants in each group up to 6months post-dose.Immunogenicity：To demonstrate the superiorityof neutralizing antibodyresponse in terms of geometric mean titers (GMT) of mRNA vaccine compare with inactive vaccine28 days post dose. Secondary:Immunogenicity 1. To describe binding antibodyprofile at D01,D08, D15, D29,D91 and D181 of eachstudy group. 2. To describe the neutralizing antibody profile atD08,D15,D91 and D181of 600 participants for each studyintervention group. Exploratory:Cell-mediated immunity To describe the cellular immuneresponse profile at D01, D08, D15and D29, in a subset of 30 participants for each study group. Efficacy:To describe the occurrence of virologically-confirmed COVID-19 like illness and serologically confirmed SARS-CoV-2 infection.
To evaluate the safety and efficacy of Venetoclax plus IM2 regimen for relapsed and refractory T lymphoblastic lymphoma/leukemia. Dosage of Venetoclax:100mg/d-400mg/d(dose adjustment when concomitant used with CYP3A inhibitor) for 1-28 days (at least 7 days); IM2 regimen: Ifosfamide 1-1.5g/m2/d for 5 days; Mitoxantrone 6-8g/m2/d for 3 days( or Liposome mitoxantrone 20mg/m2 d1 or Idarubicin 6-8mg/m2/d for 3 days) ;methotrexate 1-1.5g/m2/d for 1 day;
Open-label, prospective, observational, single arm, multi-center, post-marketing surveillance study to evaluate the efficacy, safety and tolerability of Ertugliflozin and Sitagliptin Con-initiation in patients with Type II Diabetes Mellitus in the Pakistani population. The study duration will be 12 months.
This is an open label safety study that will not be blinded or placebo controlled. Purpose is to evaluate the safety of Celastrol in healthy men and women volunteers, between 18 and 40 years of age, over a 90-day period. Celastrol is different than Cholesterol. Cholesterol is a risk for heart disease. Celastrol is a natural occurring compound extracted from the root of Tripterygium wilfordii, a herb used in Chinese medicine.
This study plans to enrol 1000 participants 18 years and above, with ≥10% participants ≥60 years old. According to SARS-CoV-2 vaccine vaccination history, they will be evenly divided into 2 groups, Group A and Group B. Group A: will enrol 500 participants who have received 2 doses of inactivated SARS-CoV-2 vaccine according to national immunization planning, whose last dose was given at least 6 months ago. They will be given one dose of the study vaccine (SYS6006) after enrolment. Group B: will enrol 500 participants who have received 3 doses of inactivated SARS-CoV-2 vaccine according to national immunization planning, whose last dose was given at least 6 months ago. They will be given one dose of the study vaccine (SYS6006) after enrolment. The study is devided into two stages, the first stage will enrol 200 participants with 100 in Group A and 100 in Group B. They will undergo laboratory examination, immunogenicity observation and safety observation. The first 30 participants in each group will take extra cellular immune testing; the second stage will enrol the remaining 800 participants for safety observation.
The fed bioequivalence test adopts the experimental design of single center, single oral administration, random, open, two sequence, two cycle crossover and self-control.
The Sponsor intends to develop an intravenous (i.v.) formulation of E4 for the treatment of neonatal hypoxic-ischemic encephalopathy (NHIE). E4 has not been administered intravenously to humans yet. This single-center, double-blind, placebo-controlled randomized study aims to evaluate the safety, tolerability, and PK of an i.v. E4 solution administered as single-dose or multiple dose to healthy adult volunteers.
Given that firearm ownership is legal, common, and valued by many people in the U.S, safe storage is important to minimize the risk of unauthorized access, injury and death. Safe storage is particularly important in households with children, as they are at elevated risk of death by unintentional injury or suicide if a gun is accessible in the home. However, only 1/3 of firearm-owning parents with children in the home report consistently safe storage. Decisions about firearm storage are complex, with perceived costs and benefits of different storage options varying by individual factors (i.e., primary reasons for firearm ownership, types of firearms), family factors (i.e., age and mental and physical health of household members), and community factors (i.e., crime and norms). Storage decisions affect all household members, and prior research finds that firearm owners who discuss storage with other family members have the safest storage practices. However, a recent survey study of firearm-owning US parents of school-aged youth (n=749) found that in only 55% of parenting dyads are both parties highly involved in the decision about how firearms are stored. In this sample, investigators observed that safe storage was more likely when both members of a parenting dyad were highly involved in the storage decision (regardless of their gender and whether one or both own firearms). However, at present firearm storage interventions are directed at individuals rather than family systems. Given the prevalence of pediatric firearm injuries and the role of within-family processes in storage safety, there is a critical need to develop a feasible, self-directed, family-centered firearm safety intervention. The objective of the proposed short-term project is to develop and obtain preliminary data about acceptability and feasibility of a prototype of a brief decision aid for parenting dyads. The conceptual framework for the decision aid is the Ottawa Decision Support Framework, and then investigators will adapt the Ottawa Person Decision Guide for Two to this issue and for self-facilitation outside of the clinical setting.