Clinical trials: Adverse Drug Reaction (ADR)
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
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
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
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
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
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
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
Polypharmacy
The Adverse Drug Reaction (ADRe) Profile for Polypharmacy
Polypharmacy, the use of multiple or inappropriate medications, has the potential to harm older adults by causing cognitive impairment, falls, and hospitalisations.
- Trial name
- ADRe-p (NCT03955133)
- Testing
- Adverse Drug Reaction ADRe Profile for Polypharmacy
- Where
- United Kingdom
- Volunteers
- 19 people
- Sponsor
- Swansea University
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
Urologic Diseases, Antibacterial Drug Adverse Reaction
Audit-and-feedback to Improve Antimicrobial-prescribing Among Urologists
Antimicrobial resistance is one of today''s most urgent public health problems. An important strategy to slow the spread of antimicrobial resistance is the promotion of judicious antimicrobial use.
- Trial name
- NCT04196777
- Testing
- Audit-and-feedback
- Where
- 3 sites in United States
- Volunteers
- 525 people, healthy volunteers welcome
- Sponsor
- Iowa City Veterans Affairs Medical Center
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
Adverse Drug Reaction
Educational Intervention in Pharmacovigilance for Hospital Health Professionals
Spontaneous reports by health professionals generate the signals in pharmacovigilance. However, the passive method has limitations and the most important of them are the underreporting and the poor quality of data, hindering the…
- Trial name
- EIPhv (NCT02134587)
- Testing
- Multifaceted educational intervention
- Where
- Brazil
- Volunteers
- 203 people
- Sponsor
- Universidade Estadual Paulista Júlio de Mesquita Filho
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
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
Pharmacogenetic Testing
Medication Optimization Using Pharmacogenetic Testing and the G-DIG to Reduce Polypharmacy in a Mental Health Population
Use of polypharmacy has significantly increased over the past two decades, which has unproven clinical benefit and is associate with an increased the risk of adverse side effects.
- Trial name
- MedOPT (NCT03468309)
- Testing
- Genecept Assay and G-DIG decision tool
- Where
- United States
- Volunteers
- 53 people
- Sponsor
- Seattle Institute for Biomedical and Clinical Research
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
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
Dementia
Nurse-led Medicines' Monitoring in Care Homes: a Process Evaluation
Lay Summary: The investigators have shown in randomised controlled trials and observation studies that structured nurse-led medicines' monitoring using the WWADR Profile benefits patients, for example, by reducing pain and…
- Trial name
- NCT03110471
- Testing
- West Wales Adverse Drug Reaction (WWADR) Profile, usual care
- Where
- 10 sites in United Kingdom
- Volunteers
- 60 people
- Sponsor
- Swansea University
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
Adverse Reaction to Drug, Neonatal Disorder
Exploratory Propofol Dose Finding Study In Neonates
The aim of the study is to explore the optimal propofol dose in neonates receiving a single intravenous propofol bolus for endotracheal intubation during (semi-)elective INSURE (intubation-surfactant-extubation) procedure…
- Trial name
- NEOPROP (NCT01621373)
- Testing
- propofol administration
- Where
- Belgium
- Volunteers
- 50 people
- Sponsor
- Universitaire Ziekenhuizen KU Leuven