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Safety Issues clinical trials

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NCT ID: NCT03615898 Completed - Safety Issues Clinical Trials

Medication Errors in the Spanish System of Communication of Incidents in Anaesthesia: Ten Year Analysis.

SENSAMED
Start date: January 1, 2008
Phase:
Study type: Observational

Background: The incidents related to medication are an important cause of avoidable health damage in the perioperative environment. Objectives: Describe the incidents related to medication reported in the national communication system of incidents in anaesthesia and resuscitation in Spain (SENSAR), and their relationship with morbidity. Methods: The investigators studied the incidents identified as medication errors of all those reported in the SENSAR database between January 1, 2008 and December 31, 2017. The researchers performed a descriptive analysis of independent variables: type of medication incident, moment in which the incident occurred, drug group involved and then a logistic regression in order to establish the relationship with the dependent variable: morbidity.

NCT ID: NCT03582553 Completed - Pharmacokinetics Clinical Trials

Safety and Pharmacokinetics of an Extract of Naringenin

Citrus
Start date: May 25, 2018
Phase: Early Phase 1
Study type: Interventional

This study evaluates the safety of administering single ascending doses (150, 300, 600, and 900 mg) of a citrus extract of the flavonoid narigenin, and assesses the blood concentrations of naringenin following oral administration of the extract.

NCT ID: NCT03577743 Completed - Safety Issues Clinical Trials

Effect of Bevacizumab in Metastatic Triple Negative Breast Cancer

Start date: July 1, 2018
Phase: Phase 2
Study type: Interventional

Evaluating efficacy and safety of bevacizumab when combined with chemotherapy (carboplatin and Paclitaxel ) in treatment of patient with metastatic triple negative breast cancer

NCT ID: NCT03565861 Completed - Safety Issues Clinical Trials

Safety and Pharmacokinetics of NP10679 in Normal Healthy Volunteers

Start date: April 6, 2018
Phase: Phase 1
Study type: Interventional

This study assesses the safety, tolerability and pharmacokinetics of NP10679 when delivered intravenously in escalating dose levels in comparison to placebo.

NCT ID: NCT03488186 Completed - Safety Issues Clinical Trials

PK-PD Comparative Study of Lansoprazole Capsules and Lansoprazole Enteric-coated Capsules in Healthy Chinese Volunteers

Start date: July 19, 2018
Phase: Phase 1
Study type: Interventional

The objective of this study was to compare the relative PK-PD of Lansoprazole Capsules and Lansoprazole DR Capsules in healthy Chinese volunteers.

NCT ID: NCT03488173 Completed - Safety Issues Clinical Trials

Pharmacokinetic Study of Lansoprazole Capsules in Healthy Chinese Volunteer

Start date: April 23, 2018
Phase: Phase 1
Study type: Interventional

The objective of this study was to compare pharmacokinetic of Lansoprazole Capsules 30 mg with Lansoprazole Capsules of Takeda 30 mg in healthy adult human subjects.

NCT ID: NCT03473236 Completed - Safety Issues Clinical Trials

Phase 1A Safety Trial of Inhaled PK10571 (GB002)

Start date: September 6, 2017
Phase: Phase 1
Study type: Interventional

This is a phase 1A randomized double blind placebo controlled single ascending dose and multiple ascending dose trial of inhaled PK10571 (GB002) in healthy adult subjects.

NCT ID: NCT03465475 Completed - Safety Issues Clinical Trials

Anesthetic Cost Analysis With Desflurane in Automated Gas Control Mode

Start date: July 1, 2018
Phase:
Study type: Observational

Inhalation agents constitute the major part of anesthetic drug costs (20% - 25%) and a significant portion of the applied inhalation agents are thrown into the atmosphere through the waste gas system without being absorbed by the patient. The amount of waste gas is directly correlated to the fresh gas flow (FGF). Reducing the TGA during general anesthesia reduces the consumption of inhalant agents and contributes to the reduction of greenhouse gas pollution. Risks such as hypoxia, hypercapnia, inadequate depth of anesthesia and potential toxic gas accumulation were associated with low flow anesthesia, but the patient was provided with adequate safety by following pulse oximetry, capnography, FiO2 and anesthetic gas analysis. We aimed to perform anesthetic cost analysis and patient security in automated gas control mode (AGC).

NCT ID: NCT03462108 Completed - Safety Issues Clinical Trials

Safety and Immunogenicity of Rotavirus (Bio Farma) Vaccine in Adults, Children & Neonates

Start date: April 9, 2018
Phase: Phase 1
Study type: Interventional

This study is to assess the safety of Rotavirus (Bio Farma) vaccine in adults, children and neonates.

NCT ID: NCT03461133 Completed - Emergencies Clinical Trials

Automated Early Warning Scoring on Surgical Normal Wards

Start date: January 2015
Phase: N/A
Study type: Observational

Establishment of early warning systems in hospitals was strongly recommended in recent guidelines to detect deteriorating patients early and direct them to adequate care. Upon meeting of predefined trigger criteria Medical Emergency Teams (MET) should be directed to these patients. The present study analyses the effect of introduction of an automated early warning and trigger system on two peripheral wards hosting a highly complex surgical patient cohort.