Clinical trials: Adverse Drug Reaction
Seizures
Pathogenesis of Adverse Drug Reactions
The purpose of the study is to examine the individual metabolic profiles of pediatric patients receiving carbamazepine or valproate therapy, in an attempt to determine identities of the reactive metabolites or, alternatively, the…
- Trial name
- NCT00224952
- Testing
- No intervention; Urine Collection
- Where
- 3 sites in United States
- Volunteers
- 274 people
- Sponsor
- Children's Mercy Hospital Kansas City
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
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
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
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
Analgesia, Obstetrical, Coagulation Defect; Postpartum
IV Ketorolac on Platelet Function Post-Cesarean Delivery
Cesarean delivery has become the most common surgical procedure in the US. Non-steroidal anti-inflammatory drugs (NSAIDs) have been shown to improve the quality of post-cesarean analgesia and markedly reduce opioid consumption.
- Conditions
- Analgesia, Obstetrical, Coagulation Defect; Postpartum, Nonsteroidals (NSAIDs)Toxicity, Postpartum Hemorrhage
- Trial name
- KetoPltAgg (NCT03805607)
- Testing
- Ketorolac Tromethamine 30 MG/ML
- Where
- United States
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Beth Israel Deaconess Medical Center
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
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
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
Meniscus Tear, Tibial, Pain, Postoperative
Ketorolac as an Adjuvant Agent for Postoperative Pain Control Following Arthroscopic Meniscus Surgery
The utilization of arthroscopic surgery to treat meniscus injuries has continued to increase in recent years, partly due to a younger, more active population, and improved technology and technique.
- Conditions
- Meniscus Tear, Tibial, Pain, Postoperative, Postoperative Complications, Ketorolac Adverse Reaction
- Trial name
- NCT04246541
- Testing
- Ketorolac, Oxycodone-Acetaminophen
- Where
- United States
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- University Hospitals Cleveland Medical Center
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
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
Injection Site Reaction
Prospective Study to Assess Tissue Responses After Injection With Biostimulatory Products
The objective of this study is to identify and assess in vivo tissue responses after injection with various biostimulatory products at various timepoints.
- Trial name
- NCT06093815
- Testing
- Injection
- Where
- Spain
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- Merz North America, Inc.
Medication Adherence, Medication Nonadherence
Determining the Impact of a Medication Delivery Unit on Medication Adherence of Adults With Common Cardiac Conditions
The research study is a randomized controlled trial (RCT). The primary endpoint is to compare medication adherence of adult patients recently hospitalized with a diagnosis of common cardiac conditions who require medication…
- Conditions
- Medication Adherence, Medication Nonadherence, Adverse Reaction to Drug
- Trial name
- EMMA-RCT (NCT01600677)
- Testing
- Computerized medication delivery unit, Usual care
- Where
- United States
- Volunteers
- 11 people
- Sponsor
- University of Pittsburgh
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
Ranitidine Adverse Reaction, Pharmacokinetics
Clinical Study to Investigate the Urinary Excretion of N-nitrosodimethylamine (NDMA) After Ranitidine Administration
Ranitidine is an over-the-counter and prescription drug, which decreases the amount of acid secreted by the stomach. Some ranitidine medicines contain an impurity called N-nitrosodimethylamine (NDMA) at low levels.
- Conditions
- Ranitidine Adverse Reaction, Pharmacokinetics, Food-drug Interaction
- Trial name
- NCT04397445
- Testing
- Ranitidine, Low nitrite/NDMA meals, High nitrite/NDMA meals
- Where
- United States
- Volunteers
- 18 people, healthy volunteers welcome
- Sponsor
- Food and Drug Administration (FDA)
Local Anesthetic Complication, Local Anesthetic Drug Adverse Reaction
Defining Normal Postoperative Magnetic Resonance Imaging After Total Knee Arthroplasty
The aim of this study was to describe the postoperative "baseline" magnetic resonance imaging (MRI) appearance of the ipsilateral thigh musculature after total knee arthroplasty (TKA).
- Trial name
- NCT04821245
- Where
- United States
- Volunteers
- 36 people
- Sponsor
- Benaroya Research Institute
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
Allergy Drug, Allergic Reaction
Preoperative Survey to Evaluate Patient Allergy
The study will only involve identification of the listed allergies from the electronic medical record and investigation into the symptoms that prompted this allergy listing.
- Conditions
- Allergy Drug, Allergic Reaction, Pediatric, Surgery
- Trial name
- NCT05670756
- Testing
- Survey
- Where
- United States
- Volunteers
- 250 people
- Sponsor
- Nationwide Children's Hospital