Clinical trials: Adverse Drug Related Events
Complications of Surgical and Medical Care: General Terms, Adverse Reaction to Drug
The Thai Surgical Intensive Care Study (Thai-SICU Study)
The study observed the 28 days mortality of 9 participated University base surgical intensive care unit (SICU) as well as the occurrence of adverse events in SICU.
- Conditions
- Complications of Surgical and Medical Care: General Terms, Adverse Reaction to Drug, Sequelae of External Causes of Morbidity and Mortality, Critical Illness
- Trial name
- THAI-SICU (NCT01354197)
- Where
- 9 sites in Thailand
- Volunteers
- 4,652 people
- Sponsor
- Royal College of Anesthesiologists of Thailand
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
Aging, Benzodiazepine Sedative Adverse Reaction
Optimizing Electronic Health Record Prompts With Behavioral Economics to Improve Prescribing for Older Adults
Prescribing of potentially unsafe medications for older adults is extremely common; benzodiazepines and sedative hypnotics are, for example, key drug classes frequently implicated in adverse health consequences for vulnerable…
- Conditions
- Aging, Benzodiazepine Sedative Adverse Reaction, Anticholinergic Adverse Reaction, Adverse Drug Event
- Trial name
- NUDGE-EHR (NCT04284553)
- Testing
- Order Entry, Open Encounter, Follow-up booster Alert
- Where
- United States
- Volunteers
- 216 people
- Sponsor
- Brigham and Women's Hospital
Adverse Drug Events
Pharmacists and Pharmacy Technicians to Improve Admission Medication History Accuracy
We tested two interventions to improve the accuracy of medication histories obtained at hospital admission. The interventions target elderly and chronically ill patients prone to erroneous medication histories and resultant…
- Trial name
- NCT02026453
- Testing
- Pharmacist obtains admission medication history, Pharmacy technician obtains admission medication history
- Volunteers
- 306 people
- Sponsor
- Cedars-Sinai Medical Center
Acute Pain, Dysmenorrhea
Observational Prospective Study to Evaluate AEs, Risk Factors and Drug Utilization of BUSCAPINA COMPOSITUM N in Adults From Metropolitan Lima
What AE occur in routine clinical practice, what is the incidence of AE and Adverse Drug Reaction, how many patients present with AE symptoms related to a potential liver injury.
- Trial name
- NCT02910167
- Testing
- Hyoscine n-butylbromide, Paracetamol
- Where
- Peru
- Volunteers
- 360 people
- Sponsor
- Boehringer Ingelheim
Patient Readmission, Adverse Drug Event
Regional Data Exchange to Improve Care for Veterans After Non-VA Hospitalization
Among older VA patients who have Medicare coverage, 43% use both VA and non-VA (Medicare-covered) services. VA and non-VA providers are often uninformed about encounters, treatments and test results provided in the other system.
- Conditions
- Patient Readmission, Adverse Drug Event, Cost
- Trial name
- NCT02689076
- Testing
- HIE Notification, Care transitions intervention
- Where
- 2 sites in United States
- Volunteers
- 796 people
- Sponsor
- VA Office of Research and Development
Chronic Kidney Disease
Post-authorization Safety Study in CKD Subjects Receiving HX575 i.v.
Cumulative follow-up with HX575 epoetin alfa to prospectively monitor the incidence of relevant drug-related adverse events and EPO-related lack of efficacy among Chronic Kidney Disease (CKD) subjects receiving HX575 epoetin alfa…
- Trial name
- EPO-PASS (NCT00632125)
- Testing
- HX575 recombinant human erythropoietin alfa
- Where
- 114 sites in Austria, Bulgaria and 8 more
- Volunteers
- 1,695 people
- Sponsor
- Sandoz
Aging, Benzodiazepine Sedative Adverse Reaction
NUDGE-EHR Replication Trial at Mass General Brigham
Prescribing of potentially unsafe medications for older adults is extremely common; benzodiazepines and sedative hypnotics are, for example, key drug classes frequently implicated in adverse health consequences for vulnerable…
- Conditions
- Aging, Benzodiazepine Sedative Adverse Reaction, Anticholinergic Adverse Reaction, Adverse Drug Event
- Trial name
- NUDGE-EHR (NCT05538065)
- Testing
- Follow-up booster Alert, Pre-commitment, Enhanced Alert
- Where
- United States
- Volunteers
- 201 people
- Sponsor
- Brigham and Women's Hospital
Schizophrenia, Bipolar Disorder
A Study to Evaluate the Safety and the Effects of Risperidone Compared With Other Atypical Antipsychotic Drugs on the Growth and Sexual Maturation in Children
The purpose of this study is to evaluate the effects of risperidone compared with other atypical antipsychotic drugs on the physical maturity, growth and development of children, and the risk of prolactin-related adverse events…
- Conditions
- Schizophrenia, Bipolar Disorder, Autistic Disorder, Conduct and Other Disruptive Behavior Disorders
- Trial name
- NCT01050582
- Testing
- Risperidone, Other atypical antipsychotic drugs
- Where
- 28 sites in United States, Belgium and 4 more
- Volunteers
- 244 people
- Sponsor
- Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Pain, Postoperative, Medication Adherence
Evaluation of an Interactive Opioid Risk Education Program (STOMP) for Parents
Millions of children and adolescents are prescribed opioid pain relievers each year, placing them at risk for serious adverse events and misuse in the home setting.
- Conditions
- Pain, Postoperative, Medication Adherence, Opioid Use, Knowledge, Attitudes, Practice
- Trial name
- STOMP (NCT03287622)
- Testing
- Educational Intervention, Nudge
- Where
- United States
- Volunteers
- 712 people
- Sponsor
- University of Michigan
Pain, Quality of Life
FLUAD® vs. Fluzone® High-Dose Study
The overall aim of the study is to compare safety and immunogenicity of inactivated influenza vaccine (IIV), adjuvanted (FLUAD®) versus High-Dose inactivated influenza (Fluzone® High-Dose) vaccine in persons ≥65 years (20% aged…
- Conditions
- Pain, Quality of Life, Injection Site Reaction, Side Effect of Drug
- Trial name
- NCT03183908
- Testing
- FLUAD®, Fluzone® High-Dose
- Where
- 4 sites in United States
- Volunteers
- 757 people, healthy volunteers welcome
- Sponsor
- Duke University
Adverse Drug Events, Adverse Drug Reactions
Pharmacogenetic Testing Among Home Health Patients
Patients meeting eligibility criteria will be randomized into two groups, one receiving pharmacogenetic testing and the other not receiving pharmacogenetic testing.
- Conditions
- Adverse Drug Events, Adverse Drug Reactions, Drug Interaction Potentiation, Drug Metabolism, Poor, CYP2D6-RELATED
- Trial name
- NCT02378220
- Testing
- Pharmacogenetic testing
- Where
- United States
- Volunteers
- 110 people
- Sponsor
- Genelex Corporation
Kidney Failure, Acute
Achieving Medication Safety During Acute Kidney Injury
The utilization of clinical decision support (CDS) is increasing among healthcare facilities which have implemented computerized physician order entry or electronic medical records.
- Trial name
- NCT01134900
- Testing
- Pharmacy Dashboard Review and Intervention
- Where
- United States
- Volunteers
- 540 people
- Sponsor
- Vanderbilt University
Adverse Drug Events
Eliminating Risk of Preventable Adverse Drug Events at the Hospital-community Interface of Care
This initiative aims to decrease the risk of medication errors at the hospital-community interface as well as health system utilization following hospital discharge by implementing a pharmacist-led medication reconciliation in…
- Trial name
- CMR (NCT01164137)
- Testing
- Medication Reconciliation
- Where
- Canada
- Volunteers
- 156 people, healthy volunteers welcome
- Sponsor
- Westview Physician Collaborative
MEDICATION RELATED OSTEONECROSIS OF THE JAW
OZONE_EXO: Comparative Analysis of Protocols for Dental Exactions in Patients at Risk of MRONJ: Case-control Study
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
- OZONE_EXO (NCT06072404)
- Testing
- OxigenOzone_Insufflation
- Where
- Italy
- Volunteers
- 117 people, healthy volunteers welcome
- Sponsor
- University of Palermo
Drug-Related Side Effects and Adverse Reactions, Adverse Drug Events
The Secure Messaging for Medication Reconciliation Tool (SMMRT) Trial
Medication discrepancies, defined as unintentional differences found between patients' medical records and patients' reports of the medication they are taking, occur frequently after hospital discharge, predisposing to adverse…
- Trial name
- SMMRT (NCT02482025)
- Testing
- SMMRT
- Where
- United States
- Volunteers
- 240 people
- Sponsor
- VA Office of Research and Development
Venous Thromboembolism, Deep Venous Thrombosis
Minimization of Bleeding Related Adverse Drug Events in Plastic & Reconstructive Surgery
Plastic and reconstructive surgeons consistently create large, raw surfaces as part of their operative procedures. Thus, plastic \& reconstructive surgery patients are among those at highest risk for anticoagulant-associated…
- Conditions
- Venous Thromboembolism, Deep Venous Thrombosis, Pulmonary Embolus, Reconstructive Surgery
- Trial name
- NCT03212365
- Testing
- Fixed dose, Variable dose
- Where
- 2 sites in United States
- Volunteers
- 295 people
- Sponsor
- University of Utah
Adverse Drug Events
Implementation of Real-time ADE Surveillance and Decision Support
The purpose of this study is to determine if an electronic alerting technology improves time to intervention for possible ADEs, identify what factors affect adoption of ADE alerts, and whether there is a cost benefit associated…
- Trial name
- VA ADE (NCT00780572)
- Testing
- ADE alert assistant
- Where
- United States
- Volunteers
- 595 people
- Sponsor
- VA Office of Research and Development
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