Clinical trials: Adverse Drug Event
Drug Abuse, Harm Reduction
Harm Reduction Intervention for Anabolic-androgenic Steroids Users: a Randomized Controlled Trial
This clinical trial aims to investigate the short and long-term efficacy of a harm reduction intervention in reducing the use of non-clinical anabolic-androgenic steroids (AAS) in abusive users of AAS.
- Conditions
- Drug Abuse, Harm Reduction, Minimization, Harm, Anabolic Steroids Adverse Events
- Trial name
- SOS-RCT-HR (NCT07039539)
- Testing
- harm reduction intervention in non-clinical anabolic-androgenic steroids users
- Where
- Brazil
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- University of Sao Paulo
Pain, Injection Site Reaction
Safety of Pediatric COVID-19 Vaccination
This is a prospective, observational study. During the study, children and adolescents (ages ≥ 5 to < 16) will be followed post administration of mRNA COVID-19 vaccines.
- Conditions
- Pain, Injection Site Reaction, Adverse Drug Event
- Trial name
- NCT05157191
- Testing
- Observational
- Where
- 5 sites in United States
- Volunteers
- 299 people, healthy volunteers welcome
- Sponsor
- Duke University
Adverse Drug Event
Effectiveness of an ADE-related Hospitalization Risk Prediction Tool for Patients (ADE-RED)
The rationale for this study is to evaluate the effectiveness of a risk prediction tool for patients who are at high risk for ADEs resulting in hospitalization or ED revisit.
- Trial name
- NCT04181775
- Testing
- ADE-RED scoring tool
- Where
- United States
- Volunteers
- 471 people
- Sponsor
- Methodist Health System
ALL, Childhood, Pediatric Cancer
Pharmacogenomic Association Study in Indian Children With Acute Lymphoblastic Leukemia
A five-year prospective observational cohort study. The study is focused on observing the relation between static germline variants and therapeutic response in Indian children with acute lymphoblastic leukemia (ALL).
- Conditions
- ALL, Childhood, Pediatric Cancer, Toxicity, Drug, Adverse Drug Event
- Trial name
- MPGx-INDALL (NCT05512169)
- Where
- 2 sites in India
- Volunteers
- 556 people
- Sponsor
- University of Geneva, Switzerland
Malignancy, Immune Related Adverse Events
Evaluating Informatics-assisted Immune-related Adverse Event Detection to Improve Registration Onto a Biorepository
Immunotherapies have improved cancer outcomes, but have a unique profile of immune-related adverse events (irAEs). Biorepositories have been established to collect data and samples to help improve our understanding of irAEs…
- Trial name
- NCT06789601
- Testing
- Informatics system for eligibility monitoring, Standard eligibility monitoring
- Where
- 2 sites in United States
- Volunteers
- 100 people
- Sponsor
- Brigham and Women's Hospital
Irritable Bowel Syndrome, Functional Abdominal Pain Syndrome
Peppermint Oil for the Treatment of Irritable Bowel Syndrome or Functional Abdominal Pain in Children: the MINT Study
Peppermint oil has shown to be effective in the treatment of Irritable Bowel Syndrome (IBS) symptoms in adults. Few studies of low quality are performed in an paediatric setting.
- Conditions
- Irritable Bowel Syndrome, Functional Abdominal Pain Syndrome, Child, Adolescent
- Trial name
- MINT (NCT05799053)
- Testing
- Small intestinal release peppermint oil, Peppermint sweets
- Where
- 3 sites in Netherlands
- Volunteers
- 228 people
- Sponsor
- St. Antonius Hospital
Adverse Drug Event
Impact of a Pharmacovigilance Program Led by Advanced Practice Nursing
HYPOTHESIS An advanced practice nursing intervention in the area of pharmacovigilance performed on patients and professionals improves the identification and reporting of suspected adverse drug reactions (ADR) and improves the…
- Trial name
- IMPACTO (NCT05402254)
- Testing
- Pharmacovigilance Program
- Where
- Spain
- Volunteers
- 395 people, healthy volunteers welcome
- Sponsor
- Natalia Rodriguez Galan
Adverse Drug Event
Evaluation of the Implementation of the Pharmacogenetics and Personalized Medicine Program "MedeA" in the Extremadura Health Service.
An open longitudinal observational study, non-randomized, which will include the adult population, attended by the SES, in which preference will be given to those patients under treatment with drugs that can produce relevant…
- Trial name
- MedeA (NCT06607445)
- Where
- Spain
- Volunteers
- 6,445 people, healthy volunteers welcome
- Sponsor
- Complejo Hospitalario Universitario de Badajoz
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
Oncolytic Virus, Diffuse Intrinsic Pontine Glioma
Oncolytic Virus Ad-TD-nsIL12 for Progressive Pediatric Diffuse Intrinsic Pontine Glioma
This is a single-arm, single-center, drug safety assessment clinical trial with a 3+3 dose escalation design, to observe the safety, tolerability and toxicity of a novel oncolytic virus Ad-TD-nsIL12 intratumoral injection in…
- Conditions
- Oncolytic Virus, Diffuse Intrinsic Pontine Glioma, Adverse Drug Event
- Trial name
- NCT05717699
- Testing
- Ad-TD-nsIL12
- Where
- China
- Volunteers
- 18 people
- Sponsor
- Capital Medical University
Oncolytic Virus, Diffuse Intrinsic Pontine Glioma
Oncolytic Virus Ad-TD-nsIL12 for Primary Pediatric Diffuse Intrinsic Pontine Glioma
This is a drug safety assessment clinical trial with a 3+3 dose escalation design, to observe the safety, tolerability and toxicity of a novel oncolytic virus Ad-TD-nsIL12 intratumoral injection in primary DIPG patients…
- Conditions
- Oncolytic Virus, Diffuse Intrinsic Pontine Glioma, Adverse Drug Event
- Trial name
- NCT05717712
- Testing
- Ad-TD-nsIL12
- Where
- China
- Volunteers
- 18 people
- Sponsor
- Capital Medical University
Adverse Drug Events
Improving Safety by Basic Computerizing Outpatient Prescribing
The study will measure the effect of basic clinical decision support on medical errors and adverse drug events in the ambulatory setting.
- Trial name
- NCT01091038
- Testing
- Basic Clinical Decision Support, Routine Care
- Where
- 2 sites in United States
- Volunteers
- 228 people
- Sponsor
- Indiana University
Acute Lymphoblastic Leukemia, Pediatric, Adverse Drug Event
Pharmacogenomic Analysis in Pediatric Acute Lymphoblastic Leukemia
This is a retrospective biobank study evaluating the impact of novel genetic variants in a population of 6-mercaptopurine treated pediatric acute lymphoblastic leukemia patients.
- Trial name
- NCT04770922
- Where
- United States
- Volunteers
- 80 people
- Sponsor
- Cipherome, Inc.
Safety Surveillance, Adverse Drug Events
Post-marketing Safety Surveillance of Qizhi Tongluo Capsules:a Registry Study.
This registry aims to monitor the safety of Qizhi Tongluo Capsules and to identify the potential risk factors for its adverse drug reactions.
- Conditions
- Safety Surveillance, Adverse Drug Events, Adverse Drug Reactions, Severe Adverse Events
- Trial name
- NCT04479553
- Testing
- Qizhi Tongluo Capsules
- Where
- 14 sites in China
- Volunteers
- 30,000 people
- Sponsor
- Zhong Wang
Neonatal Intensive Care Unit, Medication Errors
Drug-Related Problems in Neonatal Patients
Drug-related problems in newborn babies have been reported with a rate of 4-30%. It is estimated that the higher rates of these problems in hospitalized children under the age of two are related to the variety of drugs used and…
- Conditions
- Neonatal Intensive Care Unit, Medication Errors, Drug-Related Problems, Adverse Drug Event
- Trial name
- NCT04899960
- Testing
- Clinical Pharmacist Intervention
- Where
- Turkey (Türkiye)
- Volunteers
- 512 people
- Sponsor
- Hacettepe University
Adverse Drug Event, Adverse Drug Reactions
Post-marketing Safety Surveillance of Xueshuantong-Injection : a Registry Study
This registry aims to monitor the safety of Xueshuantong Injection and to identify the potential risk factors for the adverse drug reactions.
- Conditions
- Adverse Drug Event, Adverse Drug Reactions, Anaphylactic Reaction, Severe Adverse Reactions
- Trial name
- NCT03640884
- Testing
- Xueshuantong-Injection
- Where
- 14 sites in China
- Volunteers
- 30,000 people
- Sponsor
- Zhong Wang
Adverse Drug Event, Adverse Drug Reaction
Post-marketing Safety Surveillance of Breviscapine Powder-Injection : a Registry Study
This registry aims to monitor the safety of Breviscapine Powder-Injection and to identify the potential risk factors for the adverse drug reactions.
- Conditions
- Adverse Drug Event, Adverse Drug Reaction, Chinese Medicine, Anaphylactic Reaction
- Trial name
- NCT02559960
- Testing
- Breviscapine Powder-Injection
- Where
- 15 sites in China
- Volunteers
- 20,000 people
- Sponsor
- Zhong Wang
Adverse Drug Event
Improving Wisely - Polypharmacy
This is a randomized controlled trial that uses an audit and feedback intervention to alert primary care physicians who are outliers in one or more metrics related to high risk prescribing of participants' outlier status.
- Trial name
- NCT03857100
- Testing
- Audit and feedback - letter and report
- Where
- United States
- Volunteers
- 11,000 people
- Sponsor
- Johns Hopkins University
Adverse Drug Event
Monitoring of Metabolic Adverse Events of Second Generation Antipsychotics in a Naive Pediatric Population
Introduction: Second Generation Antipsychotics (SGAs) are widely used in the pediatric population. It is currently established that SGAs may induce undesirable metabolic adverse events (AEs) such as weight gain, metabolic changes…
- Trial name
- MEMAS (NCT04395326)
- Where
- Canada
- Volunteers
- 120 people
- Sponsor
- St. Justine's Hospital
Overdose, Adverse Event
Consequences of Doing What Should Not be Done in Primary Care
Retrospective observational study in a random selection of 5% of digital records active between 2014 and 2017 to quantify the frequency of Do not do primary care recommendations, calculating the over-cost related to them and…
- Trial name
- SOBRINA (NCT03482232)
- Testing
- Benzodiazepines, Non-steroidal anti-inflammatory drugs, paracetamol
- Where
- 2 sites in Spain
- Volunteers
- 750,000 people
- Sponsor
- Universidad Miguel Hernandez de Elche