Clinical trials: Pediatric Safety and Effectiveness
Multiple Sclerosis
A Study to Evaluate Efficacy, Safety, and Tolerability of Alemtuzumab in Pediatric Patients With RRMS With Disease Activity on Prior DMT
Primary Objective: To evaluate the efficacy, safety, and tolerability of alemtuzumab intravenously (IV) in pediatric participants from 10 to less than (<) 18 years of age with Relapsing Remitting Multiple Sclerosis (RRMS) who…
- Trial name
- LemKids (NCT03368664)
- Testing
- Alemtuzumab GZ402673, Glatiramer acetate, Beta-Interferon
- Where
- 13 sites in France, Italy and 4 more
- Volunteers
- 16 people
- Sponsor
- Genzyme, a Sanofi Company
Autism Spectrum Disorder
A Study to Evaluate the Efficacy and Safety of Lactococcus Lactis KD10 Powder for Improving Autism Spectrum Symptoms in Children With Autism Spectrum Symptoms.
This human study aims to evaluate the efficacy and safety of Lactococcus lactis KD10 powder for improving autism spectrum disorder symptoms in patients with autism spectrum disorder.
- Trial name
- NCT06650644
- Testing
- Lactococcus lactis KD10 (health food)
- Where
- 2 sites in South Korea
- Volunteers
- 48 people
- Sponsor
- Miae Oh
Pediatric Ventricular Septal Defects
Hybrid Closure of Congenital Heart Disease
Ventricular septal defect (VSD) is one of the most common pediatric congenital malformations. In recent years, in view of the rapid rise of transthoracic minimally invasive hybrid closure for pediatric VSD in the clinical…
- Trial name
- NCT02794584
- Testing
- sufentanil anesthesia, Hybrid closure, Control
- Volunteers
- 200 people
- Sponsor
- Nanjing Medical University
Relapsed Pediatric Solid Tumor, Refractory Pediatric Solid Tumor
Combination Chemotherapy With Pazopanib in Children and Adolescents With Relapsed/Refractory Solid Tumors
The purpose of this study is to evaluate the safety and efficacy of combination chemotherapy with Pazopanib in pediatric patients with relapsed/refractory solid tumor
- Trial name
- NCT03628131
- Testing
- Pazopanib, Ifosfamide, Carboplatin
- Where
- South Korea
- Volunteers
- 46 people
- Sponsor
- Samsung Medical Center
Migraine
A Comparison of the Efficacy and Safety of Topiramate Versus Placebo in Preventing Migraine Headaches in Children
The purpose of this study is to assess the safety and efficacy of topiramate as compared to placebo in preventing migraines in children.
- Trial name
- NCT00237302
- Testing
- topiramate
- Volunteers
- 162 people
- Sponsor
- Ortho-McNeil Neurologics, Inc.
Increasing the First Aid Knowledge and Practice Levels of Parents, Accidental Injuries
Evaluation of the Effectiveness of the First Aid Program Applied to Parents of 0-6 Year Old Children
Purpose: Accidents/injuries seen in children aged 0-6 in developed and developing countries are among the leading preventable health problems and are among the leading causes of death and disability.
- Conditions
- Increasing the First Aid Knowledge and Practice Levels of Parents, Accidental Injuries, Pediatric Emergency Care, First Aid Training
- Trial name
- NCT07066007
- Testing
- First Aid Education Programme
- Where
- Turkey (Türkiye)
- Volunteers
- 74 people, healthy volunteers welcome
- Sponsor
- Semra SÖNGÜT
COVID-19
EPIC-Peds: A Study to Learn About the Study Medicine Called PF-07321332 (Nirmatrelvir)/Ritonavir in Patients Under 18 Years of Age With COVID-19 That Are Not Hospitalized But Are at Risk for Severe Disease
The purpose of this clinical trial is to learn about the safety, pharmacokinetics (pharmacokinetics helps us understand how the drug is changed and eliminated from your body after you take it), and efficacy (how well a study…
- Trial name
- NCT05261139
- Testing
- nirmatrelvir, ritonavir
- Where
- 73 sites in United States, Bulgaria and 5 more
- Volunteers
- 160 people
- Sponsor
- Pfizer
Ulcerative Colitis
A Study to Learn More About How Risankizumab Works in Young Participants With Ulcerative Colitis
Ulcerative colitis (UC) is a type of inflammatory bowel disease that causes inflammation and bleeding from the lining of the rectum and colon (large intestine).
- Trial name
- MIGHTY (NCT07071519)
- Testing
- Risankizumab
- Where
- 73 sites in United States, Belgium and 14 more
- Volunteers
- 120 people
- Sponsor
- AbbVie
Adenovirus Infections
A Phase 3 Trial to Compare IV BCV Versus IV CDV for Treatment of Adenovirus Infection After Allo-HCT
This randomized, open-label, parallel group, two-arm, multi-center assessment will compare IV BCV with IV CDV in adult and pediatric allogeneic HCT recipients with AdV viremia.
- Trial name
- ENOVIA (NCT07387367)
- Testing
- cidofovir, Brincidofovir
- Where
- 81 sites in United States, Austria and 11 more
- Volunteers
- 180 people
- Sponsor
- SymBio Pharmaceuticals
Cardiac Catheterization, Pediatric
Efficacy and Safety of a Combined Dexmedetomidine-Ketamine Sedation Regimen for Pediatric Cardiac Catheterization
The goal of this observational study is to learn if the spontaneous sedation regimen of dexmedetomidine-ketamine (KETADEX) has the comparable efficacy and safety in pediatric cardiac catheterization versus the traditional…
- Trial name
- KETADEX (NCT07564531)
- Testing
- Spontaneous sedation regimen, General anesthesia regimen
- Where
- Vietnam
- Volunteers
- 150 people
- Sponsor
- National Children's Hospital, Vietnam
Duchenne Muscular Dystrophy
A Study to Assess the Efficacy and Safety of Satralizumab in Duchenne Muscular Dystrophy (DMD)
The purpose of this study is to assess the efficacy, safety, pharmacokinetics (PK) and pharmacodynamics (PD) of satralizumab, a humanized anti-interleukin-6 receptor (aIL-6R) monoclonal antibody, in ambulatory and non-ambulatory…
- Trial name
- SHIELD DMD (NCT06450639)
- Testing
- Satralizumab
- Where
- 18 sites in United States, Denmark and 4 more
- Volunteers
- 30 people
- Sponsor
- Hoffmann-La Roche
Multiple Sclerosis
Safety and Efficacy of Fingolimod in Pediatric Patients With Multiple Sclerosis
To evaluate the safety and efficacy of fingolimod vs. interferon beta-1a i.m. in pediatric patients with multiple sclerosis (MS)
- Trial name
- NCT01892722
- Testing
- Interferon beta-1a, Fingolimod
- Where
- 73 sites in United States, Australia and 23 more
- Volunteers
- 240 people
- Sponsor
- Novartis Pharmaceuticals
Digestive System Diseases, Pancreatic Disease
Open Label Safety Study of DCI-1020 in Pediatric Cystic Fibrosis (CF) Patients
Hypothesis:DCI 1020 capsules are safe and effective in treating exocrine pancreatic insufficiency in CF patients <= 2 years of age.
- Conditions
- Digestive System Diseases, Pancreatic Disease, Cystic Fibrosis, Exocrine Pancreatic Insufficiency
- Trial name
- NCT00663975
- Testing
- DCI 1020
- Where
- United States
- Volunteers
- 24 people
- Sponsor
- Digestive Care, Inc.
Epilepsy With Partial-onset Seizures
Efficacy and Safety of Lacosamide as Adjunctive Therapy in Subjects ≥1 Month to <4 Years With Partial-onset Seizures
The purpose of this trial is to assess the efficacy, safety and tolerability of lacosamide administered as add-on therapy with 1 to 3 anti-seizure medications.
- Trial name
- NCT02477839
- Testing
- Lacosamide
- Where
- 88 sites in United States, Argentina and 24 more
- Volunteers
- 255 people
- Sponsor
- UCB BIOSCIENCES, Inc.
Nephropathic Cystinosis
DFT383 in Pediatric Participants With Nephropathic Cystinosis
An open-label, multi-center, phase I/II study to assess the safety, tolerability and efficacy of DFT383 in pediatric participants with nephropathic cystinosis, followed by a long-term extension phase.
- Trial name
- CYStem (NCT06910813)
- Testing
- DFT383
- Where
- 6 sites in United States
- Volunteers
- 30 people
- Sponsor
- Novartis Pharmaceuticals
Crohn's Disease (CD)
A Study of Vedolizumab in Children and Teenagers With Moderate to Severe Crohn's Disease (CD)
Vedolizumab is a medicine that helps to reduce inflammation and pain in the digestive system. In this study, children and teenagers with moderate to severe Crohn's disease will be treated with vedolizumab.
- Trial name
- NCT04779320
- Testing
- Vedolizumab IV
- Where
- 96 sites in United States, Australia and 16 more
- Volunteers
- 120 people
- Sponsor
- Takeda
Attention Deficit Hyperactivity Disorder
Comparison of Slow and Fast Transition From Stimulants to Atomoxetine in Children and Adolescents With Attention Deficit/Hyperactivity Disorder(ADHD)
Children and adolescents with Attention Deficit Hyperactivity Disorder (ADHD) who are not tolerating or not responding well to stimulant therapy will be included in this study.
- Trial name
- ADHD SWITCH (NCT00760747)
- Testing
- Atomoxetine
- Where
- 6 sites in Australia, Mexico and 1 more
- Volunteers
- 112 people
- Sponsor
- Eli Lilly and Company
Ulcerative Colitis
Predicting Response to Standardized Pediatric Colitis Therapy
This is a multi-center, open-label study to determine the safety and effectiveness (how well it works) of two standardized treatments called "mesalamine" (Pentasa®) and "prednisone" in children with newly diagnosed Ulcerative…
- Trial name
- PROTECT (NCT01536535)
- Testing
- Mesalazine, IV Corticosteroid, Oral Corticosteroids
- Where
- 29 sites in United States, Canada
- Volunteers
- 431 people
- Sponsor
- Connecticut Children's Medical Center
Pediatric Kidney Transplantation
Study of Safety and Efficacy of a Basiliximab, Mycophenolate Mofetil, Cyclosporine Microemulsion and Prednisone Combination Treatment Regimen in Pediatric Renal Allograft Recipients
The aim of this study is assess the safety and efficacy of the treatment regimen of basiliximab ,cyclosporine microemulsion, MMF, and prednisone combined compared to cyclosporine microemulsion, MMF and prednisone in the time to…
- Trial name
- NCT00228020
- Testing
- basiliximab, MMF(mycophenolate mofetil), cyclosporine, prednisone (or equivalent), MMF, cyclosporine, steroids
- Volunteers
- 212 people
- Sponsor
- Novartis
Conjunctivitis
Safety and Efficacy of Zylet vs Lotemax, Tobramycin and Vehicle in Pediatric Blepharoconjunctivitis
The objective of this study is to evaluate the safety and effectiveness of Zylet in comparison with Lotemax, Tobramycin and the vehicle of Zylet for the treatment of blepharoconjunctivitis in pediatric subjects.
- Trial name
- NCT00705159
- Testing
- loteprednol etabonate and tobramycin, loteprednol etabonate, Tobramycin
- Where
- United States
- Volunteers
- 137 people
- Sponsor
- Bausch & Lomb Incorporated
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