Clinical trials: Drug Side Effect
Drug/Agent Toxicity by Tissue/Organ, Leukemia
05-001: Treatment of Acute Lymphoblastic Leukemia in Children
RATIONALE: L-asparaginase is an important component of treatment for childhood acute lymphoblastic leukemia, but is also associated with notable side-effects, including hypersensitivity, pancreatitis, and thrombosis.
- Trial name
- NCT00400946
- Testing
- asparaginase, cyclophosphamide, cytarabine
- Where
- 8 sites in United States, Canada
- Volunteers
- 800 people
- Sponsor
- Dana-Farber Cancer Institute
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
Kidney Transplant; Complications, Toxicity
Effect of Tacrolimus Formulation on Neurological Side Effects in Older Kidney Transplant Recipients
Previous studies have shown that elderly patients experience higher trough levels of tacrolimus and are more sensitive to the effects of medications, they experience higher occurrence and severity of such medication related…
- Conditions
- Kidney Transplant; Complications, Toxicity, Drug Toxicity, Neurotoxicity
- Trial name
- NCT03461445
- Testing
- Envarsus, IR Tacrolimus
- Where
- United States
- Volunteers
- 64 people
- Sponsor
- University of California, Davis
Sepsis, Critical Illness
Optimizing Vancomycin Therapy in Children
The purpose of Opt Vanc is to evaluate the feasibility of Bayesian dose adaptation, based on a previously-developed population pharmacokinetic (PK) model and a single optimally timed PK sample, to predict vancomycin area under…
- Conditions
- Sepsis, Critical Illness, Infections, Drug Toxicity
- Trial name
- Opt Vanc (NCT05691309)
- Where
- United States
- Volunteers
- 29 people
- Sponsor
- Children's Hospital of Philadelphia
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 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
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
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
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
Brain and Central Nervous System Tumors, Drug/Agent Toxicity by Tissue/Organ
Treating Patients With Recurrent PCNSL With Carboplatin/BBBD and Adding Rituxan To The Treatment Regimen
RATIONALE: Monoclonal antibodies, such as rituximab, can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells.
- Conditions
- Brain and Central Nervous System Tumors, Drug/Agent Toxicity by Tissue/Organ, Lymphoma, Thrombocytopenia
- Trial name
- NCT00074165
- Testing
- Rituxan, Cyclophosphamide, Etoposide
- Where
- 2 sites in United States
- Volunteers
- 17 people
- Sponsor
- OHSU Knight Cancer Institute
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 Toxicity
MW151-101: First-in-human Study of MW151
MW01-2-151SRM (=MW151), a small molecule, is being developed for the treatment of cognitive disorders. The development program is based on nonclinical evidence that MW151 improves neurocognitive outcomes in animal models of…
- Trial name
- NCT04120233
- Testing
- MW151, 10mg, MW151, 20mg, MW151, 40mg
- Where
- United States
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Linda Van Eldik
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
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
Breast Cancer, Hormone Changes
Triptorelin for Preserving Ovarian Function in Premenopausal Women Receiving Chemotherapy for Early-Stage Breast Cancer
RATIONALE: Drugs used in chemotherapy work in different ways to stop tumor cells from dividing so they stop growing or die. Chemoprotective drugs, such as triptorelin, may protect normal ovarian cells from the side effects of…
- Conditions
- Breast Cancer, Hormone Changes, Drug Toxicity
- Trial name
- NCT00090844
- Testing
- triptorelin
- Where
- 9 sites in United States
- Volunteers
- 49 people
- Sponsor
- University of South Florida
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
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
Hepatitis C, Chronic
An Observational Study of the Safety of Direct-acting Antivirals in Patients With Hepatitis C
The investigators will assess whether patients with the Hepatitis C virus (HCV) who are prescribed direct-acting antiviral (DAA) medications experience higher rates of adverse events than patients with HCV who are untreated.
- Trial name
- NCT03423641
- Testing
- Direct Acting Antivirals
- Volunteers
- 33,808 people
- Sponsor
- Kaiser Permanente
Drug-Related Side Effects and Adverse Reactions
A Positron Emission Tomography (PET) Imaging Study to Investigate the Biodistribution and Clearance of an Albumin Binding Domain Antibody (AlbudAb) GSK3128349 in Healthy Male Subjects
GSK3128349 is a small protein molecule (biopharmaceutical) that binds to albumin in the body, and by itself, has no pharmacological action.
- Trial name
- NCT02829307
- Testing
- 89Zr-GSK3128349 1 mg
- Where
- Netherlands
- Volunteers
- 8 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline