Clinical trials: Side Effect
Early-Onset Neonatal Sepsis, Antibiotic Side Effect
Individualized Duration of Antibiotic Treatment in Early Onset Infection in Newborns.
A nationwide multicenter open label randomized controlled non-inferiority trial, including 18 departments. The study aims to compare an individualized antibiotic treatment duration with standard seven days of antibiotic treatment…
- Trial name
- DurATi-n (NCT05329701)
- Testing
- Individualized treatment duration strategy
- Where
- Denmark
- Volunteers
- 488 people
- Sponsor
- Ulrikka Nygaard
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
Transfusion Reaction, Transfusion Related Complication
Transfusion Surveillance in Anaesthesia
the aim of this register is to collect exhaustively the different data available surrounding a transfusion act in the context of an active haemorrhage.
- Conditions
- Transfusion Reaction, Transfusion Related Complication, Anesthesia, Anesthesia; Shock
- Trial name
- STAR (NCT06403163)
- Testing
- Transfusion
- Where
- Belgium
- Volunteers
- 50,000 people
- Sponsor
- Erasme University Hospital
Childhood Cancer, Cancer-related Problem/Condition
Effect of Cognitively Challenging Physical Activity on Executive Functions in Pediatric Cancer Patients
When it comes to exercise and sport for children and adolescents with cancer, there is often still the opinion that physical activity has a negative effect on the weakened body suffering from cancer.
- Conditions
- Childhood Cancer, Cancer-related Problem/Condition, Cognitive Side Effects of Cancer Therapy, Physical Activity
- Trial name
- KiKli Fit (NCT06839794)
- Testing
- Cognitively challenging physical activity for paediatric cancer patients, Physical activity recommendations
- Where
- Switzerland
- Volunteers
- 70 people
- Sponsor
- University of Bern
Cancer, Oncology
Longitudinal Registry Including Patients Treated With Heavy Particles
The purpose of this registry is to collect retrospective and prospective standardized data of patients treated with particle therapy, either with protons or carbon ions, at the National Center for Oncological Hadrontherapy (CNAO)…
- Conditions
- Cancer, Oncology, Radiation Exposure, Radiotherapy Side Effect
- Trial name
- NCT05203250
- Testing
- Heavy-ion therapy (hadrontherapy)
- Where
- Italy
- Volunteers
- 3,000 people
- Sponsor
- CNAO National Center of Oncological Hadrontherapy
Overactive Bladder (OAB), Drug Delivery Systems
Transdermal Versus Oral Oxybutynin in Pediatric OAB
This is a prospective, randomized controlled clinical trial designed to compare the efficacy and safety of transdermal versus oral oxybutynin in children diagnosed with overactive bladder (OAB) who remain symptomatic despite…
- Conditions
- Overactive Bladder (OAB), Drug Delivery Systems, Anticholinergic Side Effects, Children and Adolescents, Boys and Girls
- Trial name
- NCT07081906
- Testing
- Oral Oxybutynin, transdermal oxybutinin
- Where
- Turkey (Türkiye)
- Volunteers
- 90 people
- Sponsor
- Dr. Lutfi Kirdar Kartal Training and Research Hospital
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
Infection, Bacterial, Antibiotic Side Effect
Medical Device (MD) Derived Pharmacokinetic (PK) Parameters for Vancomycin (MD-PK)
Getting the right dose of antibiotic promptly is an important part of treating infections. Unfortunately, when an infection is severe (sepsis) the body changes how it processes antibiotics.
- Conditions
- Infection, Bacterial, Antibiotic Side Effect, Antibiotic Resistant Infection, Sepsis
- Trial name
- MD-PK (NCT05950984)
- Testing
- Drug Infusion Pump Monitoring
- Where
- United Kingdom
- Volunteers
- 30 people
- Sponsor
- St George's, University of London
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
Drug-Related Side Effects and Adverse Reactions
Effect of a trAnSitional Pharmacist Intervention in geRiatric Inpatients on Hospitals Visits After dischargE
A randomized controlled trial will be performed in geriatric inpatients to investigate the impact of a multifaceted clinical pharmacy intervention on health related outcomes.
- Trial name
- ASPIRE (NCT04617340)
- Testing
- Multifaceted clinical pharmacy intervention
- Where
- Belgium
- Volunteers
- 827 people
- Sponsor
- Universitaire Ziekenhuizen KU Leuven
Antibiotic Side Effect
Evaluation of Bifidobacterium Breve PRL2020 in Preventing Antibiotic-Associated Side Effects From Amoxicillin or Amoxicillin/Clavulanic Acid
This study aims to evaluate the efficacy and safety of the probiotic Bifidobacterium breve PRL2020 in preventing gastrointestinal and extra-intestinal side effects caused by Amoxicillin or Amoxicillin/Clavulanic Acid in pediatric…
- Trial name
- NCT06850714
- Testing
- Bifidobacterium breve PRL2020 (Brevicillin®), Amoxicillin or Amoxicillin/Clavulanic Acid
- Where
- Italy
- Volunteers
- 800 people
- Sponsor
- Liaquat University of Medical & Health Sciences
Attention Deficit Disorder, Attention Deficit Disorder (ADD)
The Primary Objective of This Study is to Determine Whether Positively Framed Information (PFI) on Side Effects, Compared to Negatively Framed and Extensive Information (NFI) Can Reduce the Number and Severity of Reported Adverse Events Caused by ADHD Medication in Children Aged 7 to 17 Years.
The goal of this randomized controlled care evaluation is to determine whether positively framed and concise information (PFI), compared to negatively framed and extensive information (NFI) about adverse events can reduce the…
- Conditions
- Attention Deficit Disorder, Attention Deficit Disorder (ADD), Attention Deficit Disorder with Hyperactivity, ADHD
- Trial name
- NOVA (NCT06797570)
- Testing
- Communication Strategy for Side Effect Counseling in ADHD Treatment
- Volunteers
- 130 people
- Sponsor
- St. Antonius Hospital
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
Drug Toxicity
GHB Poisoning and Poisoning Induced by Others
Patients with suspected GHB poisoning presenting to Oslo Accident and Emergency Outpatient Clinic (Oslo Legevakt) or a hospital in Oslo (Oslo University Hospital Ullevål, Diakonhjemmet, Lovisenberg) will be included.
- Trial name
- NCT03651778
- Where
- Norway
- Volunteers
- 250 people
- Sponsor
- Odd Martin Vallersnes
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
COVID-19 Vaccine Adverse Reaction
Safety Study About the mRNA Vaccines Against COVID-19 in Children (PEDIVACOV-HCSC)
Drugs side effects in children need to be evaluated in a different way because of their constant growth and body changes. The use of COVID-19 vaccines (mRNA vaccines) is worldwide spread as a safety measure against the pandemic.
- Trial name
- PEDIVACOV-HCSC (NCT06646744)
- Testing
- mRNA COVID-19 vaccine
- Where
- Spain
- Volunteers
- 2,100 people, healthy volunteers welcome
- Sponsor
- Ana Belen Rivas Paterna
Tonsillectomy, Adenoidectomy
Effect of Intranasal Midazolam Versus Ketamine Midazolam Combination as a Premedication on the Occurrence of Postoperative Respiratory Adverse Events
The aim of this study is to investigate the effect of addition of intranasal ketamine to midazolam compared to midazolam alone as a premedication on the occurrence of PRAEs
- Conditions
- Tonsillectomy, Adenoidectomy, Drug-Related Side Effects and Adverse Reaction
- Trial name
- NCT06122948
- Testing
- The midazolam group, The midazolam ketamine group
- Where
- Egypt
- Volunteers
- 200 people
- Sponsor
- Kasr El Aini Hospital
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
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