View clinical trials related to Safety Issues.
Filter by:Brief Summary: Purpose: This clinical trial aims to investigate the effect of educational interventions (HeBSaPU) based on the Health Belief Model on safe pesticide use and biomarkers among greenhouse agricultural workers. The main questions it aims to answer are; 1. Compared to the control group, HeBSaPU affects safe pesticide use practices in greenhouse agricultural workers. 2. Compared to the control group, HeBSaPU affects safe pesticide use health beliefs in greenhouse agricultural workers. 3. Compared to the control group, HeBSaPU affects pesticide exposure determined by urine samples in greenhouse agricultural workers. Participants took educational interventions based on Health Belief Model (HBM) sub-dimensions; including educational posters, free personal protective equipment (PPE) incentives, short reminder messages, and demonstration components about correct PPE usage.
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 is to investigate the tolerability and safety of a ketone promoting ingredient, called a ketone ester (KE), in healthy older adults. This randomized, double-blind, placebo-controlled trial aims to characterize the tolerability and safety of daily consumption of the KE in healthy older adults (over 65 years old) over 12 weeks. Study participants will complete Beverage Tolerability Questionaires (BTQ) to rate any side side effects throughout the study. Safety will also be assessed by collection of blood and urine samples, vital signs, body weight, and monitoring of adverse events (AEs). The study will also collect pilot data to explore possible effects of KE on physical function, cognitive function and quality of life. The findings of this study will be used to facilitate future mechanistic studies of KE in aging.
Chronic pancreatitis is a rare but debilitating condition associated with chronic abdominal pain, diarrhea, diabetes, and an 8-fold increased risk for the development of pancreatic cancer. Unfortunately, there is no available treatment to prevent the progression of chronic pancreatitis, and most subjects require narcotic medications to control the pain. A receptor protein call the CCK-B receptor becomes activated in chronic pancreatitis and is in part responsible for the scar tissue or fibrosis that occurs and responsible for the cancer risk. In mice with chronic pancreatitis, the inflammation and damage was reversed with an old drug called proglumide that blocks the activation of the CCK-B receptor. Proglumide has also been shown to possibly reduce pain. This protocol involved a 2-Part study to test the safety of oral proglumide in those with confirmed chronic pancreatitis and the second goal is to determine if proglumide improves pain and function of the pancreas. Part-1 is an open-labelled Lead-in Study of N=8 subjects over a 12-week treatment period. Part-2 is a randomized double blind pseudo cross over study where subjects will be treated in Arm A (placebo for 12 weeks followed by 12 weeks of proglumide) and Arm B ( proglumide for 24 weeks).
Background: The elderly are a vulnerable group for health problems as they age. Safe care is essential when caring for the elderly at home because adverse events can happen there, such as falls, pressure ulcers, injuries, or dangers caused by medication errors. Safety culture for the elderly at home needs to be developed so that they can avoid unexpected events. This study aimed to develop the model for safety culture among the elderly called Aging Safe from the Risk (ASRi) to improve the safety culture in elderly care at home. Methods: This exploratory sequential mixed methods study will consist of three stages. Stage 1, a qualitative descriptive study, will be conducted to explore the perceptions of families, nurses, and school administrators for the elderly regarding the safety of the elderly at home. Data will be collected by interviews and focus group discussions. Stage II will involve developing The ASRi model using the modified Delphi method. The list of elderly safety culture indicators will be assessed by experts and then further developed into a model. In stage III, a model test will be conducted with a non-equivalent control group using a quasi-experimental design. The investigators will provide interventions in the form of education and training to families regarding the safety culture for the elderly at home. Findings: There is a crucial need for studies assessing the safety culture in elderly care by empowering families at home to improve safety for the elderly. The results of this study will help fill the knowledge gap in this research and can aid in developing public health policy and programs for the elderly. .
Fucoidans are fucose-rich sulfated carbohydrates found in brown marine algae and have been shown to play a role in immune modulation as well as inflammation. In fact, fucoidans have been shown to inhibit neutrophil infiltration and attenuate levels of pro-inflammatory cytokines. More research is warranted to determine the effects of supplementation with fucoidans to reduce inflammation following high-intensity exercise. Therefore, this double-blinded, randomized, placebo-controlled, cross-over design study will be conducted to further understand these effects.
The PI3K, protein kinase B (AKT), and mTOR signaling network promotes cell growth, survival, metabolism, and motility, but becomes a critical oncogenic driver under aberrant conditions that control the tumor microenvironment and angiogenesis. The PI3K-AKT-mTOR axis is the most frequently deregulated signaling pathway in primary osteosarcoma and other bone tumors. PI3Ka has high rates of 25-50% activating mutations associated with tumor formation in osteosarcoma. Other causes of pathway hyperactivation include loss of function of the tumor suppressor PTEN, gain-of-function mutations in AKT and PDK1, or upregulation of receptor tyrosine kinases. TQB3525 is an orally bioavailable, potent, dual catalytic site inhibitor of PI3Ka and PI3Kd. Tumor growth inhibition has been demonstrated in multiple xenograft osteosarcoma models with PI3K-mutant, PTEN-null cell lines. The investigators try to investigate TQB3525 in primary osteosarcoma and other bone tumors for its safety, tolerability, dose-limiting toxicities (DLT), MTD and antitumor efficacy.
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.
The SAFE-PAD Study aims to evaluate the long-term safety of paclitaxel-coated devices compared with non-paclitaxel-coated devices for femoropopliteal artery revascularization among a broad, real-world population of patients with peripheral artery disease. This multi-year analysis aims to create an ongoing mechanism to evaluate the safety of paclitaxel-coated devices in real world practice. The null hypothesis is that the paclitaxel-coated devices are associated with an increase in mortality relative to the non-drug-coated devices beyond an acceptable magnitude (i.e. the non-inferiority margin), and the alternative hypothesis is that paclitaxel-coated devices are not associated with an increase in mortality relative to the non-drug-coated devices beyond the non-inferiority margin.
This is a phase 1b investigator-initiated clinical trial that will evaluate the safety and feasibility of E-CEL UVEC® cells with the aim of improving outcomes for patients with full-thickness rotator cuff tears who undergo arthroscopic surgical repair. Allogeneic E-CEL UVEC cells will be delivered to the tendon repair site and to the muscle adjacent to the tendon repair site.