Clinical trials: Adverse Drug Reactions
Drug Toxicity
Phase I Clinical Trial to Investigate the Safety, Tolerability, Pharmacokinetics of KD101 in Healthy Male Subjects
To Evaluate the safety and tolerability after KD101 single oral dosing in healthy male subjects To Evaluate the pharmacokinetic property after KD101 single oral dosing in healthy male subjects To Evaluate the effect of food on…
- Trial name
- NCT01979380
- Testing
- KD101
- Where
- South Korea
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Kwang Dong Pharmaceutical co., ltd.
Cardiomyopathy, Cardiac Failure
Cardiac Assessment of Patients With Hip Implants
PRIMARY OBJECTIVE To establish the effect of metal ion release from metal hip implants on cardiac function STUDY OUTCOME MEASURES To assess the effect of metal ions from hip implants on cardiac function as measured by Cardiac…
- Trial name
- NCT02331264
- Testing
- Exposure to metal debris
- Where
- 2 sites in United Kingdom
- Volunteers
- 90 people, healthy volunteers welcome
- Sponsor
- Royal National Orthopaedic Hospital NHS Trust
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
Drug-Induced Acute Liver Injury
Macrophage Markers, Soluble CD163 (sCD163) and Soluble CD206 (sCD206) in Paracetamol Overdose
Paracetamol (PCM) is a widely used over-the-counter analgesic, and overdose with PCM is a condition regularly seen in everyday clinical practice.
- Trial name
- NCT03679442
- Testing
- N-acetylcysteine
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- University of Aarhus
Pain, Quality of Life
Simultaneous RZV and aIIV4 Vaccination
The overall aim of the study is to compare the safety of simultaneous Zoster Vaccine Recombinant, Adjuvanted (RZV) (SHINGRIX®) and Quadrivalent Influenza Vaccine, Adjuvanted (FLUAD®) versus simultaneous Zoster Vaccine…
- Conditions
- Pain, Quality of Life, Injection Site Reaction, Adverse Drug Event
- Trial name
- NCT05007041
- Testing
- FLUAD® Quadrivalent, Fluzone® High-Dose Quadrivalent, SHINGRIX®
- Where
- 2 sites in United States
- Volunteers
- 267 people, healthy volunteers welcome
- Sponsor
- Duke University
Breast Cancer, HER2-positive Breast Cancer
Investigating the Long-term Cardiac Sequelae of Trastuzumab Therapy
The introduction of trastuzumab for the treatment of patients with human epidermal growth factor receptor 2 (HER2) positive breast cancer has had a major impact upon cancer outcomes.
- Conditions
- Breast Cancer, HER2-positive Breast Cancer, Cardiotoxicity
- Trial name
- NCT05019365
- Where
- United Kingdom
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- University of Glasgow
Antifungal Drug Adverse Reaction
An Open-label Study to Evaluate the Effects of Concurrent Administration of Vaginal Antimycotic Medication Miconazole Nitrate on the Pharmacokinetics of Nestorone and Ethinyl Estradiol Delivered by a Contraceptive Vaginal Ring in Normal Ovulating Women
To evaluate the pharmacokinetics (PK) of EE and NES released from the CVR in the presence of a single dose and multiple doses of antimycotic co-medication (miconazole nitrate suppository or cream).
- Trial name
- NCT02215395
- Testing
- NES/EE CVR
- Where
- United States
- Volunteers
- 45 people, healthy volunteers welcome
- Sponsor
- Population Council
Weight Gain, Autism Spectrum Disorder
Pragmatic Trial Comparing Weight Gain in Children With Autism Taking Risperidone Versus Aripiprazole
This study aims to compare two FDA approved medications (aripiprazole and risperidone) for the treatment of behavioral dysregulation in children with autism spectrum disorders.
- Conditions
- Weight Gain, Autism Spectrum Disorder, Medication Side Effect
- Trial name
- NCT04903353
- Testing
- Comparison of Risperidone and Aripiprazole
- Where
- United States
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Vanderbilt University Medical Center
Injection Site, Injection Site Reaction
Sorrel 25R Injector - Sorrel Clinical Study Protocol
A prospective, open-label, single-center pilot study to evaluate the performance, safety and usability of the investigational SWI Device in healthy volunteers.
- Conditions
- Injection Site, Injection Site Reaction, Injection Site Irritation
- Trial name
- NCT05221333
- Testing
- Sorrel Wearable Injector
- Where
- United States
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- Eitan Medical
Pemphigus, Bullous Pemphigoid
Human Leukocyte Antigen Class II (DRB1 and DQB1) Alleles and Haplotypes Frequencies in Patients With Pemphigus Vulgaris Among the Russian Population
Pemphigus is a rare autoimmune life-threatening blistering condition affecting skin and mucous membranes. Pemphigus belongs to a family of polygenic disorders.
- Conditions
- Pemphigus, Bullous Pemphigoid, Stevens-Johnson Syndrome, Toxic Epidermal Necrolyses
- Trial name
- NCT05284929
- Testing
- A single blood sample for HLA typing
- Where
- Russia
- Volunteers
- 120 people, healthy volunteers welcome
- Sponsor
- Sechenov 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
Adverse Drug Event
Adverse Reactions Following COVID-19 Vaccination Among Ecuadorian Healthcare Workers
Limited large-scale studies have been conducted to investigate the adverse effects of COVID-19 vaccine in Latin America, particularly among the healthcare worker (HCW) population in Ecuador.
- Trial name
- NCT05113472
- Testing
- Pfizer-BioNTech COVID-19 vaccine
- Where
- Ecuador
- Volunteers
- 1,291 people, healthy volunteers welcome
- Sponsor
- Respiralab
Drug Reaction
Motion Sickness Medications and Vestibular Time Constant
Sea sickness represents a major limitation on the performance of ships' crew. One of the challenges faced by the physician in the motion sickness clinic when prescribing anti-sea sickness medication is to select the appropriate…
- Trial name
- NCT03270839
- Testing
- Bonine 25Mg Chewable Tablet, Kwells
- Where
- Israel
- Volunteers
- 54 people, healthy volunteers welcome
- Sponsor
- Medical Corps, Israel Defense Force
Neoplasm, Breast, Heart Failure
Breast Cancer Long-term Outcomes on Cardiac Functioning: a Longitudinal Study
Rationale: In addition to surgery, effective breast cancer (BC) treatment typically requires chemotherapy, radiotherapy, or both.
- Conditions
- Neoplasm, Breast, Heart Failure, Cardiotoxicity, Ventricular Dysfunction
- Trial name
- BLOC-II (NCT05851053)
- Testing
- Echocardiography
- Where
- Netherlands
- Volunteers
- 455 people, healthy volunteers welcome
- Sponsor
- University Medical Center Groningen
Breast Cancer
Study of the Effects of Chemotherapy on Memory and Other Mental Functions in Women With Breast Cancer
Many breast cancer patients treated with chemotherapy complain of problems with concentration and memory. This has been referred to as chemo fog.
- Trial name
- NCT00260975
- Volunteers
- 112 people, healthy volunteers welcome
- Sponsor
- Ottawa Hospital Research Institute
Drug Hypersensitivity
Management of Drug Hypersensitivity in Children
The aim of this study is (1) to assess the incidence of suspected drug allergies in a pediatric hospital and the proportion in which these reactions are confirmed to be allergic; (2) to evaluate the diagnostic values of the…
- Trial name
- DHC (NCT02031120)
- Where
- Switzerland
- Volunteers
- 207 people, healthy volunteers welcome
- Sponsor
- University Hospital, Geneva
Metabolic Side Effects of Drugs and Substances
Metabolic Imprints of Alcoholic Beverages
Metabolic imprints of five different types of alcohol will be investigated in two study groups. The study will be an assessor-blinded, parallel dietary trial (crossover design).
- Trial name
- MetAl (NCT03384147)
- Testing
- Drinking, Abstaining
- Where
- Denmark
- Volunteers
- 26 people, healthy volunteers welcome
- Sponsor
- University of Copenhagen
Drug Allergy, Neuromuscular Blockade
High Dimensional Analysis of Immune Cells in Pediatric Patients
The purpose of this study is to characterize immune cells using single-cell transcriptomic analysis in pediatric patients aged 2 to 18 years undergoing general anesthesia who are expected to receive Rocuronium, a non-depolarizing…
- Trial name
- NCT05820802
- Where
- South Korea
- Volunteers
- 294 people, healthy volunteers welcome
- Sponsor
- Seoul National University Hospital
Drug Hypersensitivity, Penicillin Allergy
Drug Challenges Without Prior Skin Testing
The investigators are conducting a prospective study to determine the safety and outcomes of placebo-controlled graded drug challenges without prior skin testing in patients with a low-risk history of antibiotic hypersensitivity…
- Conditions
- Drug Hypersensitivity, Penicillin Allergy, Antibiotic Allergy
- Trial name
- NCT03158831
- Where
- United States
- Volunteers
- 166 people, healthy volunteers welcome
- Sponsor
- Montefiore Medical Center
Adverse Drug Event
Evaluation of the Implementation of the Pharmacogenetics and Personalized Medicine Program "MedeA" in the Extremadura Health Service.
An open longitudinal observational study, non-randomized, which will include the adult population, attended by the SES, in which preference will be given to those patients under treatment with drugs that can produce relevant…
- Trial name
- MedeA (NCT06607445)
- Where
- Spain
- Volunteers
- 6,445 people, healthy volunteers welcome
- Sponsor
- Complejo Hospitalario Universitario de Badajoz