Clinical trials: Adverse Drug Event
Acute Renal Failure, Kidney Disease
Prevention of Serious Adverse Events Following Angiography
The purpose of this research study is to compare the effectiveness of intravenous isotonic sodium bicarbonate with intravenous isotonic sodium chloride and oral N-acetylcysteine (NAC) with oral placebo for the prevention of…
- Conditions
- Acute Renal Failure, Kidney Disease, Coronary Artery Disease
- Trial name
- PRESERVE (NCT01467466)
- Testing
- IV isotonic saline, IV isotonic bicarbonate, N-acetylcysteine
- Where
- 54 sites in United States, Australia and 2 more
- Volunteers
- 5,177 people
- Sponsor
- VA Office of Research and Development
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
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
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
Obesity, Cardiovascular Diseases
Naltrexone/Bupropion Cardiovascular Outcomes Study
The purpose of this study is to evaluate cardiovascular (CV) safety of naltrexone hydrochloride (HCl) and bupropion HCl extended release combination (NB) compared with placebo and rule out excess risk of major adverse…
- Trial name
- NCT02638129
- Testing
- Naltrexone HCl/Bupropion HCl ER
- Where
- 139 sites in United States
- Volunteers
- 67 people
- Sponsor
- Orexigen Therapeutics, Inc
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
Acute Heart Failure, Diuretics Drug Reactions
Diuretic Treatment in Acute Heart Failure With Volume Overload Guided by Serial Spot Urine Sodium Assessment
This is a pragmatic, multicenter, interventional, parallel-arm, randomized, open-label trial to investigate whether a diuretic regimen, based on serial assessment of sodium concentration (UNa) on spot urine samples after diuretic…
- Trial name
- DECONGEST (NCT05411991)
- Testing
- UNa measurement after intravenous loop diuretic bolus, Intravenous acetazolamide 500 mg OD, Intravenous bumetanide TID
- Where
- 2 sites in Belgium
- Volunteers
- 107 people
- Sponsor
- Vrije Universiteit Brussel
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
Drug Safety
Comparing Patient Comfort and Safety Between Iodixanol and Iopamidol in Patients Undergoing Peripheral Arteriography
The purpose of this study is to evaluate and compare overall patient comfort profile between an Iso-osmolar contrast media (IOCM), iodixanol 320 mg I/mL, and a Low-osmolar contrast media (LOCM), iopamidol 370 mg I/mL in patients…
- Trial name
- NCT01475097
- Testing
- Iodixanol, Iopamidol
- Where
- United States
- Volunteers
- 255 people
- Sponsor
- GE Healthcare
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
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
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
Small Cell Lung Cancer, Soft Tissue Sarcoma
Study of the Safety, Pharmacokinetics and Efficacy of Tinostamustine in Patients With Advanced Solid Tumors.
Tinostamustine (EDO-S101) is a first-in-class alkylating deacetylase inhibitor designed to improve drug access to deoxyribonucleic acid (DNA) strands, induce DNA damage and counteract its repair in cancer cells.
- Conditions
- Small Cell Lung Cancer, Soft Tissue Sarcoma, Triple-negative Breast Cancer, Ovarian Cancer
- Trial name
- EDO-S101 (NCT03345485)
- Testing
- Tinostamustine 60mg/m2 over 30min, Tinostamustine 80mg/m2 over 30min, Tinostamustine 100mg/m2 over 30min
- Where
- 13 sites in United States, Canada and 3 more
- Volunteers
- 71 people
- Sponsor
- Mundipharma Research Limited
Adverse Drug Effects
The Use of STOPP/START Criteria for Medication Intervention Among Elderly Population Living in a Geriatric Hospital
The purpose of this study is to determine if the use of STOPP/START criteria (STOPP-screening tool of older persons potentially inappropriate prescriptions START-screening tool to alert doctors to right treatment)for medication…
- Trial name
- STOPP (NCT01602744)
- Testing
- STOPP/START screening tools for medication intervention
- Where
- Israel
- Volunteers
- 382 people, healthy volunteers welcome
- Sponsor
- Wolfson Medical Center
Submental Fat
Evaluation the Effects of Various Treatments on RZL-012-Induced Adverse Events
This is a Phase 2, open-label, 2-stage, adaptive-design study in which subjects will be randomized into one of 5 treatment groups comprised of RZL-012 with or without additional study treatments:
- Trial name
- NCT05476679
- Testing
- RZL-012, RZL-012+Lidacaine injection prior treatment, RZL-012+Medrol
- Where
- United States
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- Raziel Therapeutics Ltd.
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