View clinical trials related to Safety Issues.
Filter by:This study aimed to preliminarily determine safety and efficacy of longan and lingzhi mushroom syrup on immune and inflammatory responses. Apparently healthy Thai adults (N = 8) aged 18-60 years were recruited into a prospective, single-group study. All participants were assigned to consume 5 mL of longan and lingzhi mushroom syrup daily for 12 weeks. Blood concentrations of fasting plasma glucose (FPG), glycated hemoglobin (HbA1c), aspartate aminotransferase (AST), alanine aminotransferase (ALT), alkaline phosphatase (ALP), BUN (blood urea nitrogen), creatinine (Cr), immunoglobulins (IgG, IgM, IgA, and IgE), and C-reactive protein (CRP) were measured at baseline (week 0), week 4, week 8, and week 12.
This study is designed to test the effects of the combination of naringenin (from an extract of sweet oranges) and beta carotene on energy expenditure and glucose metabolism in a single human subject.
This is a randomised, double-blind, placebo-controlled, single ascending dose study in healthy volunteer subjects. Each dose level will be investigated with eight 20-50-year-old male subjects (6 on active drug and 2 on placebo). Additionally, eight healthy elderly subjects (65-80 years of age, males and females), 6 on active drug and 2 on placebo, will be included in the study at one dose level, once the safety and tolerability of AVLX-144 has been documented in younger subjects.
The objective of the study is to determine the safety of DAA's among chronic HCV patients. The outcomes of the study are; To determine the frequency of adverse events while receiving DAAs with or without RBV and/or Pegylated Interferon To calculate the percentage of patients with severity of medical event as per Karch and Lasagna classification To determine the percentage of patient having serious adverse event as per ICH Classification
Firearms injuries present a major pediatric public health challenge, killing >800 children ages 0-15 annually and leading to lifelong disability among >1000 survivors. About ⅓ of firearms injuries to children under age 15 are due to unintentional causes rather than suicide or homicide. The investigators propose development and evaluation of ShootSafe, an innovative, engaging, and educational website accessible by smartphone, tablet or computer that engages children to learn firearms safety. ShootSafe extends existing programs to achieve 3 primary goals: a) teach children knowledge and skills they need to hunt, shoot, and use firearms safely; b) help children learn and hone critical cognitive skills of impulse control and hypothetical thinking needed to use firearms safely; and c) alter children's perceptions about their own vulnerability and susceptibility to firearms-related injuries, the severity of those injuries, and their perceived norms about peer behavior surrounding firearms use. ShootSafe will accomplish these goals through a combination of interactive games plus podcast videos delivered by peer actors (impactful testimonials about firearms injuries/deaths they experienced) and experts (wisdom & experience from trusted role models). The website will also incorporate brief messaging to parents, who will absorb key lessons and reinforce them with their children. The website will be evaluated through a randomized controlled trial with 162 children ages 10-12, randomly assigning children to engage in the ShootSafe website or an active control website on child nutrition. The investigators will incorporate sub-aims to evaluate changes in children's (a) knowledge, (b) cognitive skills in impulse control and hypothetical thinking, (c) perceptions about firearms safety, and (d) simulated behavior when handling, storing and transporting firearms. All outcome measures will be assessed at baseline, immediately post-intervention, and at a 4-month follow-up assessment to evaluate retention. Training will comprise two 30-minute sessions.
Transient Acetaminophen Induced Hypothermia in Pediatrics Population Undergoing General Anesthesia
An observational cross sectional questionnaire study looking into facial hair of hospital doctors during the COVID-19 pandemic, and how personal protective equipment guidance has affected this.
This study will be conducted in 2 phases. Phase 1 of this study will be a single-centre, open label, dose escalation first in human (FIH) study conducted in 2 groups of healthy participants. Group 1 will enrol adults aged 18-55 years (inclusive); Group 2 will enroll elderly adults (elderly) aged 56-75 years (inclusive). Phase 2 of this study will be a single centre, the proposed design will be observer-blind, placebo-controlled study to assess the safety, reactogenicity, and immunogenicity of ChulaCov19 vaccine in healthy adults (18-75 years of age inclusive).
Study of the efficiency of Béfizal® 200 mg in 14 adult patients with a LHON that occurred for less than 5 years. Patient must have certain specific mutations
This is a dose escalation trial in the elderly with obesity to determine the maximum tolerated dose of a novel dietary fiber from whole young soy pods (soy) delivered in foods.