Clinical trials: Drug Reactions
Propofol, Ketamine
Propofol-Ketamine Versus Sevoflurane for Laryngeal Mask Anesthesia in Pediatric Cardiac Catheterization
Children undergoing cardiac catheterization will be given anesthesia using either a combination of propofol and ketamine or sevoflurane gas. The time taken to fall asleep will be recorded.
- Conditions
- Propofol, Ketamine, General Anesthetic Drug Adverse Reaction
- Trial name
- NCT07907796
- Testing
- Ketamine-Propofol, Sevoflurane
- Where
- Pakistan
- Volunteers
- 68 people
- Sponsor
- Rawalpindi Institute of Cardiology
Adverse Drug Reaction, Cinepazide
Post-Marketing Surveillance of the Cinepazide Maleate Injection: a Real World Study
Cinepazide Maleate Injection is widely used in cerebrovascular disease in china. The safety of the cinepazide, especially the blood system, has not been fully evaluated in Chinese population.
- Conditions
- Adverse Drug Reaction, Cinepazide, Stroke
- Trial name
- PACER (NCT01946919)
- Where
- 61 sites in China
- Volunteers
- 18,260 people
- Sponsor
- Peking University Third Hospital
Drug Toxicity
Real World Asparaginase Therapy Toxicity
This research study is being done to learn more about the short term and long term side effects of treatment with asparaginase drugs, which are commonly used in acute lymphoblastic leukemia (ALL) or acute lymphoblastic lymphoma…
- Trial name
- NCT07008027
- Where
- United States
- Volunteers
- 200 people
- Sponsor
- St. Jude Children's Research Hospital
Weight Gain, Autism Spectrum Disorder
Pragmatic Trial Comparing Weight Gain in Children With Autism Taking Risperidone Versus Aripiprazole
This study aims to compare two FDA approved medications (aripiprazole and risperidone) for the treatment of behavioral dysregulation in children with autism spectrum disorders.
- Conditions
- Weight Gain, Autism Spectrum Disorder, Medication Side Effect
- Trial name
- NCT04903353
- Testing
- Comparison of Risperidone and Aripiprazole
- Where
- United States
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Vanderbilt University Medical Center
Adverse Drug Reactions, Clinical Decision Support
Multi-Agent Collaborative ADR Prediction With Human-Machine Decision Comparison
This study develops a multi-agent collaborative prediction model to forecast adverse drug reactions using real-world clinical medical records.
- Trial name
- NCT07808866
- Testing
- Retrospective medical record data analysis only, no clinical intervention
- Where
- 2 sites in China
- Volunteers
- 20,000 people
- Sponsor
- Peking University Third Hospital
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
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
Pediatric Disorder, Genetic Predisposition
Pharmacogenomic Contributions to Trihexyphenidyl Biotransformation and Response in Children With Dystonic Cerebral Palsy
This study looks at how a medicine called trihexyphenidyl works in children with dystonic cerebral palsy. The study aims to understand how trihexyphenidyl is broken down and used in the body of pediatric patients and whether this…
- Conditions
- Pediatric Disorder, Genetic Predisposition, Dystonia, Secondary, Dystonia
- Trial name
- TRIKE2 (NCT06554288)
- Testing
- Trihexyphenidyl
- Where
- United States
- Volunteers
- 40 people
- Sponsor
- Children's Mercy Hospital Kansas City
Obsessive-Compulsive Disorder, Anxiety Disorders
Pharmacogenetics of Antidepressant-Induced Disinhibition
The purpose of this study is to identify pharmacogenetic profiles associated with selective serotonin reuptake inhibitors (SSRI)-induced behavioral disinhibition in children with Major depressive disorder (MDD), anxiety disorders…
- Conditions
- Obsessive-Compulsive Disorder, Anxiety Disorders, Major Depressive Disorder, Antidepressant Drug Adverse Reaction
- Trial name
- PGx-AID (NCT03953014)
- Where
- Canada
- Volunteers
- 120 people
- Sponsor
- University of Calgary
Linezolid, Tuberculosis Multi Drug Resistant Active
Linezolid Tolerance During the BPaL Regimen With Dosage Personalization Based on Therapeutic Drug Monitoring (TDM) During Multidrug-Resistant Tuberculosis Treatment
Multidrug-resistant tuberculosis (MDR-TB) poses a significant challenge to global public health. Globally, the World Health Organization (WHO) estimates the number at 400,000 patients with MDR-TB for 2023.
- Conditions
- Linezolid, Tuberculosis Multi Drug Resistant Active, Therapeutic Drug Monitoring (TDM)
- Trial name
- PLOT-TB (NCT07477119)
- Testing
- Linezolid dose personalization based on TDM
- Where
- Guinea
- Volunteers
- 150 people
- Sponsor
- Marco Schiuma
Adverse Drug Reaction (ADR)
National Active Surveillance Network and Pharmacogenomics of Adverse Drug Reactions in Children
The purpose of the study is (1) to identify and collect samples from children and adults who take drugs and have adverse drug reactions AND children and adults who take drugs and do not experience any adverse drug effects; (2) to…
- Trial name
- NCT00414115
- Where
- Canada
- Volunteers
- 7,000 people, healthy volunteers welcome
- Sponsor
- University of British Columbia
Adverse Drug Reaction (ADR)
Integrating Pediatric Pharmacogenomic Testing Into the Canadian Health Care System
This project addresses the problem of adverse drug reactions in the three most frequently prescribed therapeutic classes of drugs in children: antibiotics, analgesics, and mental health medications.
- Trial name
- NCT04249375
- Where
- 2 sites in Canada
- Volunteers
- 150 people
- Sponsor
- University of British Columbia
Diarrhea, Drug/Agent Toxicity by Tissue/Organ
N2003-01: Irinotecan, Temozolomide, and Cefixime in Treating Young Patients With Recurrent or Resistant Neuroblastoma
RATIONALE: Drugs used in chemotherapy, such as irinotecan and temozolomide, work in different ways to stop tumor cells from dividing so they stop growing or die.
- Conditions
- Diarrhea, Drug/Agent Toxicity by Tissue/Organ, Neuroblastoma
- Trial name
- NCT00093353
- Testing
- cefixime, irinotecan hydrochloride, temozolomide
- Where
- 13 sites in United States
- Volunteers
- 30 people
- Sponsor
- New Approaches to Neuroblastoma Therapy Consortium
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
Adverse Drug Reaction (ADR)
The INTEGRATE Study: Integrated Pharmacogenetics, TDM and Active Pharmacovigilance as Innovative Tools for the Optimisation and Appropriateness of Drug Therapy
The primary goal of this observational study is to evaluate the feasibility of implementing a multidisciplinary approach based on pharmacogenetics, TDM (Therapeutic Drug Monitoring) and MedReview into the clinical practice in…
- Trial name
- INTEGRATE (NCT06822959)
- Testing
- Pharmacogenetics, TDM and MedReview
- Where
- 2 sites in Italy
- Volunteers
- 450 people
- Sponsor
- Direzione centrale salute, politiche sociali e disabilità
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
Behavioral Activation, Major Depressive Disorder
Pharmacogenomics of Selective Serotonin Reuptake Inhibitor (SSRI)-Induced Behavioural Activation
The purpose of this study is to identify and validate a panel of genetic markers associated with selective serotonin reuptake inhibitors (SSRI)-induced behavioural activation in children and youth with major depressive disorder…
- Conditions
- Behavioral Activation, Major Depressive Disorder, Anxiety Disorders, Antidepressant Drug Adverse Reaction
- Trial name
- PGx-SImBA (NCT06763081)
- Testing
- Not applicable- observational study
- Where
- 2 sites in Canada
- Volunteers
- 160 people
- Sponsor
- University of Manitoba
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 Reaction, Therapy Failure
Pharmacogenetic Testing of Patients With Unwanted Adverse Drug Reactions or Therapy Failure
Genetic makeup of a patient influences the efficacy and safety profile of a drug. This study is to summarize individual cases, where Pharmacogenetics (PGx) has been applied during pharmaceutical care.
- Trial name
- NCT04154553
- Testing
- Buccal swab, EDTA Blood sample (4.9mL), Serum sample (7.5mL)
- Where
- Switzerland
- Volunteers
- 400 people, healthy volunteers welcome
- Sponsor
- University Hospital, Basel, Switzerland