View clinical trials related to Drug Safety.
Filter by:In this non-interventional one year study, data about overall and particularly gastrointestinal tolerability, indications, cardiovascular risk factors and compliance are collected by basic questionnaires, which are handed out by pharmacists to patients who acquire (in Germany no prescription is needed) Rx (Prescription) or OTC (Over-The-counter) Aspirin protect (enteric coated aspirin) 100 mg and are willing to participate in the study. After 3, 6, 9 and 12 months follow-up questionnaires are sent out. Aim of the study is to get information about safety, usage and compliance under everyday's conditions, because in Germany low-dose aspirin is an OTC product with Rx indication.
The purpose of this study is to characterize plasma and urinary concentrations of ceftaroline following intravenous administration of a single dose of ceftaroline 600 mg in healthy subjects who are normal weight, overweight, and obese.
The purpose of this study is to confirm the safety and the therapeutic effect of Decitabine in the treatment of elderly Acute Myeloid Leukemia (AML) patients.
The purpose of this study is to test the efficacy and safety of dexmedetomidine added to ropivacaine in patients undergoing shoulder surgery.
The purpose of this study is to assess the safety and tolerability of MDT-637, when inhaled by subjects with Intermittent, or Mild-to-Moderate Persistent, Asthma.
This is a single-center, randomized, double-blind, placebo-controlled, ascending multiple-dose study of VIA-3196 to evaluate the Safety, Pharmacokinetics and Pharmacodynamics of VIA-3196 in Healthy Subjects. Study dosing is organized into cohorts corresponding to escalating doses of VIA-3196 or matching placebo. Subjects will be dosed daily for 14 days.
Ascorbic acid (Vitamin C) could protect renal toxicity from colistin.
The purpose of the study is to assess the tolerability and safety of a range of repeated inhaled doses of MDT-637. This includes monitoring effects on pulmonary function and determination of blood levels of MDT-637 following inhalation.
The purpose of this study is to evaluate and compare overall patient comfort profile between an Iso-osmolar contrast media (IOCM), iodixanol 320 mg I/mL, and a Low-osmolar contrast media (LOCM), iopamidol 370 mg I/mL in patients undergoing arteriography of peripheral arteries.
Nonanesthesiologist administration of propofol for sedation is actually a field of growing interest for endoscopists, as demonstrated by recent American and European guidelines on this issue. Propofol is a hypnotic drug with rapid onset and offset of action. Used as a single agent, it is commonly titrated to deep sedation, whereas balanced propofol sedation (BPS), which combines propofol with small doses of a benzodiazepine and/or an opioid, can be successfully titrated to moderate sedation. However, nonanesthesiologists propofol administration remains controversial on account of the possibility of deep sedation/general anesthesia related adverse events. On the other hand, the use of longer elimination half-life drugs, such as opioids and benzodiazepines, may theoretically prolong sedation and recovery. Up to date, no study has addressed a head-to-head comparison of both regimens administered by non-anesthesiologists and titrated to moderate sedation. This study aims to evaluate the impact on propofol sedation of premedication with a fixed dose of midazolam (2 mg)2 minutes before propofol administration targeted to moderate sedation, in terms of depth of sedation, recovery times, safety and satisfaction. The onset of sedative action of midazolam has been reported to be 1-2.5 minutes and the peak effect of midazolam occurs 8-12 minutes. Taking into account that colonoscopy usually lasts a minimum of 15-20 minutes, our hypothesis is that synergy between propofol and midazolam may increase the depth of sedation through the initial phases of the procedure, diminishing propofol requirements, but not prolonging significantly recovery times.