View clinical trials related to Safety Issues.
Filter by:Evaluate the tolerance of a probiotic formula in infants
The aim of the Clinical study is to evaluate the pharmacokinetic and safety profile of a new formulation of Bevacizumab (Zutrab®, Argentinian origin) when compared to two already marketed formulations of Bevacizumab Avastin® (reference product) and Cizumab® (Indian origin), to establish similarity.
This is a phase 1 study to evaluate the safety of Ga68-Dolacga Injection in healthy volunteers and to assess the normal reference range and inter-individual variability of the Ga68-Dolacga Injection in estimating liver reserve in healthy volunteers.
This study explores the utility of a tablet computer-based, individually-tailored application called Computer Intervention Authoring Software (CIAS) in the Emergency Department for discharge education on proper child car restraint safety. The investigators hypothesize that tablet-based, individually-tailored discharge instructions are more effective than current standard, one-size-fits-all, printed discharge instructions. This is a randomized, controlled, non-blinded trial of of children age 0-21 years old in the Emergency Department. Patients will be randomized to receive either (a) a brief tablet-based questionnaire followed by standard, paper discharge instructions or (b) a brief tablet-based questionnaire followed by the intervention - CIAS, a tablet-based computer program. One week after discharge, participants in both groups will receive an automatic text message and/or email message with a link to a web-based survey that will assess: knowledge of appropriate car restraints and whether the parent/patient engaged in any behavioral changes regarding child car restraint. These variables will be compared between the control and intervention groups.
To assess the safety of autologous volume- and red blood cell (RBC)-reduced non-cryopreserved umbilical cord blood (UCB) cell infusion to preterm infants.
to assess safety and immunogenicity of measles-rubella (MR) routine immunization in Indonesian Children and Infants
The aim of the present study was to determine whether oral dosing, up to 9 grams/day, of porous silica administered as a food additive can be used safely in normal weight and obese male humans, without significant side effects on gastrointestinal function, bowel emptying habits, and biomarkers.
Caesalpinia spinosa extract is rich in gallotannins and other well characterized polyphenols and has a major antioxidant activity. The extract shows immunomodulatory activity in healthy animals and anti-tumor activity in animals with breast cancer and melanoma as well. The use of P2Et in animals with tumors shows a synergistic effect with doxorubicin in drug-resistant cell lines. In addition, an increase in survival of transplanted animals with a TS/A breast cancer tumor model and treated with P2Et, in conjunction with calreticulin increase is observed. This open-label, single arm, Phase 1 study intends to assess the safety of P2Et extract obtained from Caesalpinia spinosa, with dose escalation, in healthy voluntary participants in Colombia.
Medication reconciliation is a systematic process by which health care professionals obtain the most complete and accurate information about the drugs regularly taken by patients. Internationally, the value of this procedure is mainly attributed to the reduction in the number of adverse drug events, which can cause drug-related morbidity and mortality, as well as unnecessary health care costs. As part of the Progress! Pilot project Safe Pharmacotherapy at the interface points, promoted by the Federal Office of Public Health, coordinated by the Swiss Patients Safety Foundation and held in several Swiss hospitals, medication reconciliation at hospital admission was introduced at the regional hospital Beata Vergine in Mendrisio, from 2014 to 2016. During this pilot project it was shown that medication reconciliation after obtaining the best possible medication history by a pharmacist at hospital admission, in comparison with the standard medication history obtained by the physician at admission, reduced the number of clinically relevant drug discrepancies. A structured, well-established and practicable procedure of medication reconciliation that improves patient safety assuring a better quality of care at hospital admission might provide evidence that medication reconciliation could be a valuable intervention to be applied systematically in all EOC hospitals at admission, as well as subsequently potentially at the other hospital interfaces. The purpose of this study is to evaluate whether obtaining the best possible medication history and performing medication reconciliation at hospital admission results in improving some specific healthcare outcomes. The study seeks primarily to determine if obtaining the best possible medication history and performing medication reconciliation, in comparison with the standard medication history, reduces the number of subsequent unplanned all-cause hospital visits (readmissions and emergency department visits within 30 days after initial discharge). As secondary objectives, the study aims at assessing if best possible medication history with medication reconciliation, in comparison with the standard medication history, reduces the incidence of adverse drug reactions during hospital stay, shortens length of stay, leads to a reduction in the use of hospital resources, and/or is associated with a decreased number of deaths.
In Hong Kong, approximately 80% of children are myopic by the end of childhood. There is intense interest currently in the potential role of peripheral defocus as a clinical treatment to slow myopia progression. One of the most successful treatments for myopia is orthokeratology. Currently, Breath-O correct lenses are new designed ready-made orthokeratology lenses. This study is to evaluate the safety of wearing this new orthokeratology lens and the effectiveness of clinical performance in young adult.