View clinical trials related to Safety Issues.
Filter by:The European Food Safety Authority has approved many applications for UVB light treated foods (e.g. UVB-exposed button mushrooms) in the last years. The UVB light treatment is used to increase the vitamin D content in foods and improve the vitamin D status of subjects. However, UVB irradiation is accompanied by the formation of vitamin D photoisomers such as lumisterol and tachysterol. The current study aims to investigated whether these vitamin D photoisomers can enter the circulation and are metabolised in humans that consume UVB-treated mushrooms.
The treatment plan for patients requiring mechanical ventilator support is to provide the minimal amount of analgesics and sedatives necessary for the patient to tolerate the ventilator as lower amounts of these drugs has been shown to improve patient outcomes. Patients in this critical state experience confusion, restlessness, and agitation, which sometimes leads to an unplanned removal of a patient's line or medical device. The current standard of care for limiting the movement of mechanically ventilated patients' in the critical care units in hospitals is the use of physical wrist restraints. Researchers demonstrated that wrist restraints are ineffective in preventing the removal of invasive and adjunct devices and have many negative physical, psychological, physiological, and emotional consequences for the patient and their family. In this proposed research, we will use the innovative medical device called the HEALiX, a newly developed device worn on the arms of mechanically ventilated patients that allows freedom of movement and protects from removing adjunct mechanical ventilation devices and invasive monitoring equipment. This randomized controlled trial will investigate the HEALiX device's effectiveness in preventing the removal of invasive monitoring devices (such as endotracheal tubes, central lines, feeding tubes, etc.) compared with the current standard of care, wrist restraints.
Randomized, open, single-center, controlled prospective studies were designed to obtain reliable level I evidence in evidence-based medicine.Based on the premise of at least a 6-fold reduction in pancreatic fistula, as observed by Kawai et al after early drainage.Considering the overall incidence of pancreatic fistula after standard pancreatectomy at our center (approximately 20%), we would expect this complication to occur in approximately 3.4% of cases in Group A.α was set as 0.05 and β was set as 0.2 (efficacy was 80%), indicating that the total number of study subjects was at least 114 patients (at least 57 patients in the experimental group and 57 patients in the control group).
The aim of the research is to find out what effect the standardization of ambulance equipment has on the speed of performing specific medical procedures.
Safety of healthcare professionals working in high-risk environments is of upmost importance. Personal protective equipment (PPE) may affect the performance of individuals and teams by altering their senses, manual skills and ability to communicate. Current guidelines offer flexibility in terms of which specific PPE components can safely be used. Yet, in some organisations, healthcare workers become used to using PPE well above the recommended standards (termed further in text as super-safe setup, SSS). Impact of this PPE policy on team performance and in turn to patient safety is unknown. The investigators hypothesise that SSS, as compared to WHO PPE standard, would negatively impact team performance and patient outcomes in a simulated crisis scenario.
Despite the initial success of the 1970s Poison Prevention Packaging Act, the incidence of pediatric medication poisonings in the United States remains high. Unintentional pediatric medication ingestions result in significant morbidity and are associated with substantial healthcare use and costs. A majority of these medication poisonings involve a caregivers' medication and are caused by modifiable unsafe storage behaviors. A better understanding of factors associated with pediatric poisonings and safe medication storage behaviors is needed to inform public health policy and develop targeted educational interventions. Furthermore, low-cost, scalable interventions that improve medication storage behaviors and reduce pediatric poisonings are necessary to address this ongoing preventable public health crisis. In preliminary experiments, a baseline evaluation of caregivers demonstrated that they are unlikely to have a locked medication storage device in their home, but would be willing to use a locked device if one was available. Additionally, a follow-up assessment indicated that a majority of caregivers had used their medication over a one-month period. The latter feasibility assessment supports both caregiver willingness to use a safe storage device and demonstrates that a storage device can improve medication storage behaviors in the short-term. Given these findings, we hypothesize that pediatric medication poisonings are due to improper storage, that medication storage behaviors are influenced by demographic and household specific factors, and that medication lockboxes improve safe medication storage behaviors and reduce pediatric poisonings. These hypotheses will be evaluated using the studies in the following Specific Aims: (1) to identify factors associated with pediatric poisonings, (2) to identify factors associated with medication storage behaviors, (3) to evaluate the effect of lockboxes on storage behaviors and pediatric poisonings. Should this exploratory study reveal factors associated with increased risk for pediatric poisoning or with safe medication storage, and should safe medication storage interventions improve modifiable storage behaviors or show a reduction in pediatric poisonings, the results will be used to inform targeted public health campaigns and to develop a low-cost, scalable national program for improving safe medication storage and reducing pediatric poisonings.
A randomized, prospective study of the efficacy and safety of the first-line treatment in advanced central non-small cell lung cancer patients by anti-PD-1 / PD-L1 monoclonal antibody and chemotherapy versus anti-PD-1 / PD-L1 monoclonal antibody and chemotherapy combined with bronchoscopic microwave intervention
A randomized controlled clinical trial will be carried out using inspiratory and expiratory training devices on healthy subjects recruited in social networks and university environments. The aim will be to determine the effectiveness and safety in the prevention and severity of COVID-19 disease by a respiratory training with inspiratory and expiratory devices.
The prevention of catheter-related complications is nowadays an important topic of research. Flushing the catheters is considered an important clinical procedure in preventing malfunction and several complications such as phlebitis or infection. Considering the latest guidelines of the Infusion Nurses Society, the flushing involves a pre and post-drug administration, requiring different syringes (with associated overall increased times of preparation/administration of intravenous medication by nurses, also increasing the need for manipulation of the venous catheter). A multi-centre, two-arm randomised controlled trial with partially blinded outcome assessment, of 146 adult patients. After eligibility analysis and informed consent, participants will receive usual intravenous administration of drugs with subsequent flushing procedures, with the double-chamber syringe (arm A) or with the classical syringes (arm B). The outcomes assessment will be performed on a daily basis by the unblind research team, with the same procedures in both groups. Some main outcomes, such as phlebitis and infiltration, will also be evaluated by nurses from a blind research team and registered once a day.
To study the safety and effect of autologous umbilical cord blood stem cells for treatment brain injury