Clinical trials: Adverse Drug Events
Dexmedetomidine, Sedation
Safety Exploration and Evaluation of Dexmedetomidine Hydrochloride Nasal Spray for Pre-anesthesia Sedation in Low-Monitoring Settings
The goal of this clinical trial is to assess the viability of dexmedetomidine hydrochloride nasal spray under minimal or no supervision and to further investigate novel clinical applications for this medication.
- Conditions
- Dexmedetomidine, Sedation, Safety, Preanesthetic Medication
- Trial name
- NCT07298525
- Testing
- Dexmedetomidine hydrochloride nasal spray
- Volunteers
- 564 people, healthy volunteers welcome
- Sponsor
- Sichuan Provincial People's Hospital
Healthy Volunteer, Hypersensitivity Reactions
Novel Biomarkers of Non-IgE Immediate Hypersensitivity Drug Reactions
The goal of this clinical trial is to investigate biomarkers of non-IgE-mediated immediate hypersensitivity reactions during infusion of intravenous vancomycin.
- Conditions
- Healthy Volunteer, Hypersensitivity Reactions, Vancomycin
- Trial name
- NCT07605806
- Testing
- Vancomycin (IV)
- Where
- United States
- Volunteers
- 25 people, healthy volunteers welcome
- Sponsor
- Johns Hopkins University
Pain, Injection Site Reaction
Safety of Pediatric COVID-19 Vaccination
This is a prospective, observational study. During the study, children and adolescents (ages ≥ 5 to < 16) will be followed post administration of mRNA COVID-19 vaccines.
- Conditions
- Pain, Injection Site Reaction, Adverse Drug Event
- Trial name
- NCT05157191
- Testing
- Observational
- Where
- 5 sites in United States
- Volunteers
- 299 people, healthy volunteers welcome
- Sponsor
- Duke University
Tuberculosis, Drug-Induced Liver Injury
A Pharamcogenomic Study for Isoniazid According to NAT2 Polymorphism Status
A clinical trial to investigate the appropriate dose of isoniazid according to NAT2 polymorphism status in Korean subjects
- Conditions
- Tuberculosis, Drug-Induced Liver Injury, Adverse Drug Event
- Trial name
- NCT03665402
- Testing
- Isoniazid
- Where
- South Korea
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- Seoul National University Hospital
Drug Hypersensitivity, DRESS Syndrome
Origin and Function of Eosinophilic Polynuclear During DRESS Syndrome
Drug Hypersensitivity Syndrome or DRESS for "Drug Reaction with Eosinophilia and Systemic Symptoms" is a serious drug allergy which can be life-threatening for patients with serious organ damage.
- Trial name
- DRESSEO (NCT04330118)
- Where
- 11 sites in France
- Volunteers
- 80 people, healthy volunteers welcome
- Sponsor
- University Hospital, Lille
Quality of Life, Injection Site Reaction
Simultaneous mRNA COVID-19 and IIV4 Vaccination Study
This study is a prospective, randomized clinical trial. During this study, participants will be randomly assigned to receive quadrivalent inactivated influenza vaccine (IIV4) and mRNA COVID-19 vaccine either simultaneously or…
- Conditions
- Quality of Life, Injection Site Reaction, Adverse Drug Event, Systemic Reaction
- Trial name
- NCT05028361
- Testing
- mRNA COVID-19, IIV4
- Where
- 3 sites in United States
- Volunteers
- 348 people, healthy volunteers welcome
- Sponsor
- Duke University
Healthy Volunteer Study
Safety Study of CZ10 in Healthy Volunteers
A randomized, double-blind, placebo-controlled, parallel group, dose escalation study in healthy subjects to evaluate the safety, tolerability, pharmacokinetics and initial effectiveness of a novel intravenous CT contrast…
- Trial name
- NCT06708767
- Testing
- Contrast Media
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Nextrast, Inc.
Depression, Adverse Reaction to Drug
Pharmacogenomic Study to Predict Antidepressant Responsiveness in Depressed Patients
The purpose of this study is to determine whether pharmacogenomic study predict antidepressant responsiveness in advance before the appearance of the drug effects until 4~6 weeks after drug administration.
- Trial name
- NCT00817375
- Testing
- SSRI treated group, non-SSRI treated group
- Where
- South Korea
- Volunteers
- 1,000 people, healthy volunteers welcome
- Sponsor
- Samsung Medical Center
Helicobacter Pylori Infection
Trimebutine on the Development of Adverse Events Related to the Helicobacter Pylori Eradication Medications
Adverse events related to the eradication medication is one of the reason of lower eradication success in the H. pylori treatment.
- Trial name
- NCT04403087
- Testing
- Trimebutine 100 MG
- Where
- South Korea
- Volunteers
- 132 people, healthy volunteers welcome
- Sponsor
- Chuncheon Sacred Heart Hospital
Non-steroidal Anti-inflammatory Drug Adverse Reaction
Research for Prevention and Treatment of NSAIDs Related Gastrointestinal Side Effects
We aim to evaluate the protective effects of eradication of HP and continue using Geranylgeranylacetone (GGA) on NSAIDs related gastroenterological lesions.
- Trial name
- NCT01547559
- Testing
- part1:teprenone, part1:EAC-T, part1:EA-EMC-T
- Where
- 2 sites in China
- Volunteers
- 369 people, healthy volunteers welcome
- Sponsor
- Sun Yat-sen University
MEDICATION RELATED OSTEONECROSIS OF THE JAW
Infiltration of Medical Ozone for the Treatment of Medication-Related Osteonecrosis of the Jaws (MRONJ)
Medication-related osteonecrosis of the jaw (MRONJ) is a serious adverse reaction of antiresorptive and antiangiogenic agents; it is also a potentially painful and debilitating condition.
- Trial name
- OZOPROMAF (NCT05036837)
- Testing
- OZOPROMAF_SEQ1
- Where
- Italy
- Volunteers
- 50 people, healthy volunteers welcome
- Sponsor
- University of Palermo
Healthy Volunteer
A Study to Evaluate Adverse Events and How the Drug Moves Through the Body From Subcutaneous (SC) and Intravenous (IV) Doses of ABBV-382 in Healthy Adult Chinese Volunteers
The main objectives of this study are to evaluate the safety, tolerability, pharmacokinetics, and immunogenicity of single subcutaneous (SC) and intravenous (IV) doses of ABBV-382 in healthy adult Chinese volunteers.
- Trial name
- NCT06632938
- Testing
- ABBV-382
- Where
- China
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- AbbVie
Pediatric ALL
Medication Errors and Adverse Drug Events (ADEs) in Ambulatory Pediatrics
The purpose of this study is to determine the rates of medication errors in pediatric outpatients in 6 office practices. Further, we wish to determine the effectiveness of a computerized physician order entry (CPOE) system in…
- Trial name
- NCT00229671
- Testing
- Survey 1, Survey 2
- Where
- United States
- Volunteers
- 6,341 people, healthy volunteers welcome
- Sponsor
- Weill Medical College of Cornell University
Adverse Drug Effect of Opioids, Adverse Drug Effect of Benzodiazepines
Reducing Concurrent Opioid-Benzodiazepine Prescriptions
The purpose of this effort is to use informative e-mails to improve the process of prescribing of opioids and benzodiazepines within the National Capital Region/Military Health System (NCR/MHS), with the aim of decreasing…
- Trial name
- NCT03887247
- Testing
- E-mail Alert
- Where
- United States
- Volunteers
- 2,234 people, healthy volunteers welcome
- Sponsor
- Walter Reed National Military Medical Center
HIV/AIDS, Antiviral Toxicity
Relative Mitochondrial Toxicity of Tenofovir Alafenamide (TAF) vs. Tenofovir Disoproxil Fumarate (TDF)
Increased comorbidities such as cardiovascular disease (CVD), are emerging problems in HIV infection but the mechanisms are unclear.
- Conditions
- HIV/AIDS, Antiviral Toxicity, Antiviral Drug Adverse Reaction, Mitochondrial Alteration
- Trial name
- UCLACAREMITO (NCT03251144)
- Testing
- Switch to E/C/FTC/TAF daily
- Where
- United States
- Volunteers
- 26 people, healthy volunteers welcome
- Sponsor
- University of California, Los Angeles
Healthy Volunteer
A Study to Assess How the Drug Moves Through the Body, Adverse Events, and Tolerability of Oral ABBV-722 Capsules of Single and Multiple Ascending Doses in Adult Participants and Single Doses in Adult Asian Participants
This is a Phase 1, first-in-human study to investigate safety, tolerability, and pharmacokinetics of ABBV-722 after oral dosing in healthy adult participants.
- Trial name
- NCT06673238
- Testing
- ABBV-722
- Where
- 2 sites in United States
- Volunteers
- 95 people, healthy volunteers welcome
- Sponsor
- AbbVie
Drug Reactions
Effects of Repeated Doses of Lu AF35700 on Drug Metabolizing Enzymes
This study will help determine which types of drugs that may interact with Lu AF35700
- Trial name
- NCT03195946
- Testing
- Lu AF35700, Midazolam, Cocktail of CYP450 substrates
- Where
- United Kingdom
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- H. Lundbeck A/S
Medication Administered in Error, Adverse Drug Events
Ambulatory Medication Reconciliation Following Hospital Discharge
Adverse drug events (ADEs) after hospital discharge are common. The purpose of this research study is see if we can design an electronic tool given to your primary care provider (PCP) that will reduce adverse drug events…
- Trial name
- NCT00740675
- Testing
- Outpatient Medication Reconciliation
- Where
- 2 sites in United States
- Volunteers
- 912 people, healthy volunteers welcome
- Sponsor
- Brigham and Women's Hospital
HIV Infections, Gonorrhea
Cellulose Sulfate (CS) Gel and HIV in Nigeria
This is a Phase 3, multi-center, randomized, placebo-controlled trial to determine the effectiveness and safety of the 6% cellulose sulfate (CS) vaginal gel for the prevention of HIV infection.
- Conditions
- HIV Infections, Gonorrhea, Chlamydia Infections
- Trial name
- NCT00120770
- Testing
- Cellulose Sulfate Vaginal Gel (Microbicide)
- Where
- 2 sites in Nigeria
- Volunteers
- 2,160 people, healthy volunteers welcome
- Sponsor
- FHI 360
Adverse Drug Event
Ametop - Friend and Foe A Prospective Study of the Incidence of Adverse Reactions With Ametop
Ametop was introduced into the formulary as it was deemed more efficacious for intravenous cannulation compared to EMLA. However, the incidences of adverse reactions seemed to be higher compared to other studies.
- Trial name
- NCT02750137
- Testing
- Tetracaine
- Volunteers
- 192 people, healthy volunteers welcome
- Sponsor
- KK Women's and Children's Hospital