Clinical trials: Adverse Drug Events
Crohn Disease
Personalising Anti-TNF Therapy in Crohns Disease (PANTS)
To develop a cost-effective, individualised anti-TNF treatment strategy for patients with Crohn's disease which maximizes benefit and minimises harm.
- Trial name
- PANTS (NCT03088449)
- Where
- United Kingdom
- Volunteers
- 1,750 people
- Sponsor
- Royal Devon and Exeter NHS Foundation Trust
Adverse Effects, Adverse Drug Event
How Safe Are Our Pediatric Emergency Departments?
Patient safety is an internationally recognized health care priority. Canadian data suggests that about 8% of adults admitted to hospital experience unintended harm (or 'adverse events') from the health care provided during their…
- Trial name
- NCT02162147
- Where
- 10 sites in Canada
- Volunteers
- 6,385 people
- Sponsor
- Children's Hospital of Eastern Ontario
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
Hospitalized Children
Relationship Between Adverse Drug Reactions and Unlicensed/ Off-label Drug Use in Hospitalized Children
Medications are the most commonly used clinical intervention and complications associated with their use are one of the most common causes of adverse events in health care.
- Trial name
- EREMI (NCT02852590)
- Where
- France
- Volunteers
- 6,227 people
- Sponsor
- Hospices Civils de Lyon
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
Peripheral Arterial Disease(PAD)
Effect of Anticoagulant and Antiplatelet Drug Intervention on Postoperative Major Adverse Events in Patients with PAD：Phase II
This study is a multicenter, prospective, observational research project. It is anticipated to enroll a total of 6,000 patients between February 1, 2025, and January 31, 2028 (with completion of one-year postoperative follow-up…
- Trial name
- NCT06850207
- Volunteers
- 6,000 people
- Sponsor
- Chengdu University of Traditional Chinese Medicine
Behavioral Activation, Major Depressive Disorder
Pharmacogenomics of Selective Serotonin Reuptake Inhibitor (SSRI)-Induced Behavioural Activation
The purpose of this study is to identify and validate a panel of genetic markers associated with selective serotonin reuptake inhibitors (SSRI)-induced behavioural activation in children and youth with major depressive disorder…
- Conditions
- Behavioral Activation, Major Depressive Disorder, Anxiety Disorders, Antidepressant Drug Adverse Reaction
- Trial name
- PGx-SImBA (NCT06763081)
- Testing
- Not applicable- observational study
- Where
- 2 sites in Canada
- Volunteers
- 160 people
- Sponsor
- University of Manitoba
Medication Safety
Pharmacist and Data Driven Quality Improvement in Primary Care
P-DQIP is an intervention to improve prescribing safety in primary care. The 'intervention' is a health board quality improvement programme that will be implemented across all practices in one National Health Service (NHS) board…
- Trial name
- P-DQIP (NCT03747107)
- Testing
- P-DQIP
- Where
- United Kingdom
- Volunteers
- 19 people
- Sponsor
- University of Dundee
Adverse Effect of Other Antipsychotics and Neuroleptics
Adverse Events and Genomics in Schizophrenia
The purpose of this study is to find genes that predict whether or not a person will develop side effects to antipsychotic medications, such as weight gain, blood sugar dysregulation, or immune cell abnormalities.
- Trial name
- AEGIS (NCT01966588)
- Testing
- Blood samples for whole genomic/transcriptomic sequencing, UKU Side Effect Rating Scale
- Where
- Canada
- Volunteers
- 100 people
- Sponsor
- University of British Columbia
Positron-Emission Tomography and Cone-Beam Computed Tomography
Registry Type Study to Monitor for Adverse Drug Reactions to Fedoruk Manufactured [F-18]-Fludeoxyglucose
This is a single-centre, open-label, non-randomized clinical trial designed to monitor the occurrence of adverse events associated with [F-18]-FDG Injection manufactured by the Fedoruk Centre.
- Trial name
- NCT02811185
- Testing
- [F-18]-Fludeoxyglucose
- Volunteers
- 1,012 people
- Sponsor
- University of Saskatchewan
Drug Hypersensitivity
Evaluation of TNF-α Blockade Effect in Patients With Severe Cutaneous Adverse Drug Reactions
Severe skin adverse drug reactions can result in death. Toxic epidermal necrolysis (TEN) has the highest mortality (30-35%); Stevens-Johnson syndrome and transitional forms correspond to the same syndrome, but with less extensive…
- Trial name
- NCT01276314
- Testing
- anti- TNF-a, Prednisolone
- Where
- Taiwan
- Volunteers
- 135 people
- Sponsor
- Chang Gung Memorial Hospital
Adverse Drug Events
Improving Safety by Basic Computerizing Outpatient Prescribing
The study will measure the effect of basic clinical decision support on medical errors and adverse drug events in the ambulatory setting.
- Trial name
- NCT01091038
- Testing
- Basic Clinical Decision Support, Routine Care
- Where
- 2 sites in United States
- Volunteers
- 228 people
- Sponsor
- Indiana University
Adverse Drug Reaction, Cinepazide
Post-Marketing Surveillance of the Cinepazide Maleate Injection: a Real World Study
Cinepazide Maleate Injection is widely used in cerebrovascular disease in china. The safety of the cinepazide, especially the blood system, has not been fully evaluated in Chinese population.
- Conditions
- Adverse Drug Reaction, Cinepazide, Stroke
- Trial name
- PACER (NCT01946919)
- Where
- 61 sites in China
- Volunteers
- 18,260 people
- Sponsor
- Peking University Third Hospital
Recurrent Tonsillitis, Obstructive Sleep Apnea
Post-operative Pain Control After Pediatric Adenotonsillectomy
Adenotonsillectomy is one of the most common surgical procedures performed in the pediatric population in the United States. It is generally a well-tolerated procedure with post-operative bleeding risk ranging from 3-5% in…
- Conditions
- Recurrent Tonsillitis, Obstructive Sleep Apnea, Sleep Disordered Breathing, Adverse Reaction to Drug
- Trial name
- NCT02296840
- Testing
- Ibuprofen, Hydrocodone-Acetaminophen
- Where
- United States
- Volunteers
- 45 people
- Sponsor
- Emory University
Medication Errors and Other Product Use Errors and Issues
Meds@HOME App to Support Medication Safety
This study determines whether the mHealth intervention, Meds@HOME, helps caregivers improve medication administration to Children with Medical Complexity (CMC) who use high-risk medications.
- Trial name
- NCT05816590
- Testing
- Med@HOME Mobile App
- Where
- United States
- Volunteers
- 336 people
- Sponsor
- University of Wisconsin, Madison
Parkinson Disease
A Study of Equfina® on the Incidences of Adverse Drug Reactions in Participants With Parkinson's Disease (Including Participants With Hepatic Impairment)
The purpose of the study is to investigate the incidences of psychiatric symptoms (example, hallucinations), somnolence and sudden onset of sleep, dyskinesia, and retinal degeneration-related events during treatment with Equfina…
- Trial name
- NCT04724109
- Testing
- Equfina
- Where
- 2 sites in Japan
- Volunteers
- 1,088 people
- Sponsor
- Eisai Co., Ltd.
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
Latent Tuberculosis Infection
Risk of SDRs Under 3HP and 1HP Regimen for LTBI
Successful implement of preventive therapy for subjects with latent tuberculosis infection (LTBI) is the critical step for elimination of tuberculosis (TB).
- Trial name
- NCT04094012
- Testing
- isoniazid and rifapentine
- Where
- Taiwan
- Volunteers
- 490 people
- Sponsor
- National Taiwan University Hospital
ALL, Childhood, Pediatric Cancer
Pharmacogenomic Association Study in Indian Children With Acute Lymphoblastic Leukemia
A five-year prospective observational cohort study. The study is focused on observing the relation between static germline variants and therapeutic response in Indian children with acute lymphoblastic leukemia (ALL).
- Conditions
- ALL, Childhood, Pediatric Cancer, Toxicity, Drug, Adverse Drug Event
- Trial name
- MPGx-INDALL (NCT05512169)
- Where
- 2 sites in India
- Volunteers
- 556 people
- Sponsor
- University of Geneva, Switzerland
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