View clinical trials related to Safety Issues.
Filter by:The goal of this Phase II/III study is to investigate the safty and efficacy of ADC189 tablets in adolescents and adults with influenza A virus infection/influenza B virus infection. The main aim to answer: - Phase II study is to evaluate the efficacy of ADC189 tablets in the treatment of adult influenza subjects and determine the optimal therapeutic dose by analyzing the time of virus titer turning to negative. All the results will be used to design the Phase III study. - Phase III study is to evaluate the efficacy of ADC189 tablets by analyzing the duration of remission of all influenza symptoms in adolescents and adults subjects with influenza. Participants will be taken ADC189 teblets/Placebo once, and be observed by 22 days. Phase II study has 3 groups: 15 mg ADC189; 45 mg ADC189; and Placebo; Phase III study has 2 groups: 45 mg ADC189; and Placebo.
Indications-based prescribing is a medication ordering system in which a clinician selects an indication, and then the electronic health record (EHR) suggests an appropriate medication regimen. This approach was shown to significantly decrease medication ordering errors in a prototype environment. However, the effect of indications-based prescribing on preventing ordering errors has not been rigorously evaluated in a real-world healthcare setting. Antibiotics are the medication class most likely to contain ordering errors, which can lead to significant patient harm. At NewYork-Presbyterian (NYP) a robust antimicrobial indication-based order set was developed to help clinicians identify the appropriate antibiotic, dose, frequency, and duration, based on type of infection and patient-specific characteristics, but it is not widely used. The investigators propose a randomized controlled trial to assess the effectiveness of this indications-based order set for reducing antimicrobial ordering errors.
This is an exploratory phase II study, to evaluate the impact of these Mesenchymal Stem Cells (MSCs) on strictures in Crohn's disease patients with symptomatic intestinal stricture eligible to endoscopic dilatation. The impact of combined treatment by endoscopic dilation and local injection of MSCs will be compared with that of a control group.
The goal of this interventional study is to evaluate the implementation and effectiveness of a comprehensive a universal firearm injury prevention program, ACTFAST (Adopting Comprehensive Training for FireArm Safety in Trauma centers), in level 1 trauma centers. The main aims of the study are: 1. (Primary Aim 1) Increase the adoption, implementation, and maintenance of a universal firearm injury prevention intervention at three participating trauma centers in the mid-Atlantic states; 2. (Primary Aim 2) Assess firearm injury prevention knowledge, attitudes, and safe storage practices among trauma patients treated within participating trauma centers.
The study aims to evaluate the pharmacokinetic profile, safety profile, and immunogenic potential of adalimumab of a new citrate-free formulation of adalimumab (Adalimumab Richmond) [Test Product] vs. Humira® AC Pen [Reference Product]
Lower Silesia Sinus Reducer Registry is a , single-center, single-arm registry including patients with chronic disabling refractory angina pectoris (Canadian Cardiovascular Society [CCS] classes 2-4) despite maximally tolerated anti-angina medical therapy who underwent Coronary Sinus Reducer implantation .
Limited literature has focused on the use of totally tubeless mini-percutaneous nephrolithotomy (Mini-PCNL) for the treatment of large renal stones. This Randomized Controlled trial aims to compare complication and safety of Mini-PCNL between total tubeless and tubeless Mini-PCNL.
The study aimed to evaluate the outcomes of bifurcation PCI using two techniques (Culotte vs. DK-Culotte) using data from a retrospective analysis.
This is a double-blind, placebo-controlled, randomized two-phase study to evaluate the safety and pharmacokinetics (PK) of two TAF/EVG inserts administered rectally for 3 consecutive days, then every other day for 14 days.
This study will explore the safety, pharmacokinetics (PK) and pharmacodynamics (PD) of KP405 as a potential new treatment for Parkinson's disease.