Clinical trials: Pediatrics
Type 1 Diabetes
The Summer Camp Study: Blood Glucose Control With a Bi-Hormonal Bionic Endocrine Pancreas
This study will test the hypothesis that a wearable automated bionic pancreas system that automatically delivers both insulin and glucagon can improved glycemic control vs.
- Trial name
- NCT01833988
- Testing
- Bi-hormonal Bionic Pancreas, Usual Care
- Where
- United States
- Volunteers
- 32 people
- Sponsor
- Massachusetts General Hospital
Non-Alcoholic Fatty Liver Disease
Gemcabene for the Treatment of Pediatric NAFLD
This is a multicenter, prospective, open-label, Phase 2, proof of concept study to test preliminary efficacy and safety of gemcabene in children with established nonalcoholic fatty liver disease (NAFLD) incompletely treated by…
- Trial name
- NCT03436420
- Testing
- Gemcabene
- Where
- United States
- Volunteers
- 6 people
- Sponsor
- Emory University
Molar Incisor Hypomineralization, Dental Caries
Silver Diamine Fluoride and Papain-Based Gel for Management of MIH-affected Molar in Paediatric Patients
Molar incisor hypomineralization (MIH) is a developmental defect of enamel affecting the first permanent molar and frequently the incisors with a prevalence of 16-16.9% in Malaysia.
- Conditions
- Molar Incisor Hypomineralization, Dental Caries, Hypomineralization of Enamel
- Trial name
- NCT04710927
- Testing
- Silver Diamine Fluoride, Papain-Based Gel, High Viscosity Glass Ionomer Cement (HVGIC)
- Where
- Malaysia
- Volunteers
- 38 people, healthy volunteers welcome
- Sponsor
- University of Malaya
Anesthesia, Local
Lidocaine Administration Using STAR Particles
This study is being done to answer the question: Do STAR particles (tiny pieces of ceramic with small spikes) help numbing gel (a gel that helps you feel less pain) work more quickly to provide local anesthesia or numbing in a…
- Trial name
- NCT06034340
- Testing
- LET Gel after STAR Particle Application (Right or Left Arm), LET Gel Application without STAR Particle Application (Contralateral Arm)
- Where
- United States
- Volunteers
- 22 people, healthy volunteers welcome
- Sponsor
- Emory University
Type 2 Diabetes
Computer Automation for Diagnosis and Management of Childhood Type 2 Diabetes
Increasing rates of type 2 diabetes among children and adolescents has considerable long-term implications not only for the affected individuals, but also for society and the health system as a whole.
- Trial name
- NCT01814787
- Testing
- CHICA Type 2 Diabetes Module
- Where
- United States
- Volunteers
- 1,369 people
- Sponsor
- Indiana University
Pediculosis
Pharmacokinetic (PK) and Tolerance Study of Natroba Topical Suspension in Pediatrics With an Active Head Lice Infestation
A pharmacokinetic and tolerance study of Natroba (spinosad) Topical Suspension, 0.9% in pediatric subjects 6 months to 4 years of age with an active head lice infestation.
- Trial name
- NCT01660321
- Testing
- spinosad
- Where
- 2 sites in United States
- Volunteers
- 26 people
- Sponsor
- ParaPRO LLC
Type 1 Diabetes Mellitus, Type2 Diabetes Mellitus
Performance Evaluation of an Advanced Algorithm With CGM in Adults, Adolescents, and Pediatrics
The purpose of this study is to demonstrate the performance of the Guardian™ Sensor (3) with an advanced algorithm in subjects age 2 - 80 years, for the span of 170 hours (7 days).
- Trial name
- NCT03966911
- Testing
- Guardian™ Sensor (3) connected to a Guardian™ Connect Transmitter
- Where
- 15 sites in United States
- Volunteers
- 335 people
- Sponsor
- Medtronic MiniMed, Inc.
Vascular Access Device Complications
Comparing Peripherally Inserted Central Catheters to Long Peripheral Catheters in Pediatrics
Peripherally Inserted Central Catheters (PICCs) are frequently used in hospitalized children who require prolonged vascular access; however, concerns regarding their inappropriate use and contribution to serious complications…
- Trial name
- ComPLET (NCT05346406)
- Testing
- Midline Catheter, Peripherally Inserted Central Catheter
- Where
- United States
- Volunteers
- 35 people
- Sponsor
- Medical College of Wisconsin
Phenylketonuria
Kuvan® in Phenylketonuria Patients Less Than 4 Years Old
This is a Phase 3b, multicenter, open-label, randomized, controlled study to evaluate efficacy, safety and population pharmacokinetics of sapropterin dihydrochloride (Kuvan®) in less than 4 year-old infants and children with…
- Trial name
- SPARK (NCT01376908)
- Testing
- Kuvan®, Phenylalanine (Phe)-restricted diet
- Where
- 22 sites in Austria, Belgium and 7 more
- Volunteers
- 56 people
- Sponsor
- BioMarin Pharmaceutical
HIV/AIDS Treatment, HIV Infections
Lopinavir/Ritonavir (Kaletra) PK in Children
The objective of this study is to compare the pharmacokinetics of lopinavir tablets administered to pediatric patients as either whole or crushed tablets.
- Trial name
- NCT00810108
- Testing
- lopinavir/ritonavir (Kaletra®) tablets
- Where
- 2 sites in United States
- Volunteers
- 12 people
- Sponsor
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Hypercholesterolemia
An Efficacy and Safety Study of Alirocumab in Children and Adolescents With Homozygous Familial Hypercholesterolemia
Primary Objective: To evaluate the efficacy of alirocumab (75 or 150 milligrams [mg] depending on body weight [BW]), administered every 2 weeks (Q2W), on low-density lipoprotein cholesterol (LDL-C) levels at Week 12 of treatment…
- Trial name
- NCT03510715
- Testing
- Alirocumab SAR236553 (REGN727), Atorvastatin, Simvastatin
- Where
- 10 sites in Brazil, Canada and 8 more
- Volunteers
- 18 people
- Sponsor
- Sanofi
Idiopathic Nephrotic Syndrome
UrApp for Childhood Nephrotic Syndrome Management (Incident Cohort)
Idiopathic nephrotic syndrome is one of the most common chronic kidney diseases in children. Patients suffer from frequent disease relapses and complications.
- Trial name
- NCT04075656
- Testing
- Standard of Care, UrApp
- Where
- 3 sites in United States
- Volunteers
- 58 people
- Sponsor
- Emory University
Depressive Disorder, Major
Active Reference (Fluoxetine) Fixed-dose Study of Vortioxetine in Paediatric Participants Aged 7 to 11 Years With Major Depressive Disorder (MDD)
Investigation of the efficacy and safety of a new potential treatment of Major depressive disorder (MDD) in paediatric participants (age 7 to 11 years).
- Trial name
- NCT02709655
- Testing
- Vortioxetine 10 mg/day, Vortioxetine 20 mg/day, Fluoxetine 20mg/day
- Where
- 98 sites in United States, Bulgaria and 17 more
- Volunteers
- 683 people
- Sponsor
- H. Lundbeck A/S
Acute Lymphoblastic Leukemia
Bortezomib With Chemotherapy for Relapsed Pediatric Acute Lymphoblastic Leukemia (ALL)
This is a Phase I/II study of a drug called bortezomib given in combination with chemotherapy drugs used to treat acute lymphoblastic leukemia (ALL) that has come back (recurred).
- Trial name
- NCT00440726
- Testing
- Bortezomib, Dexamethasone, PEG-asparaginase
- Where
- 24 sites in United States, Australia and 2 more
- Volunteers
- 31 people
- Sponsor
- Therapeutic Advances in Childhood Leukemia Consortium
Prader-Willi Syndrome
Effects of Exenatide on Overweight Adolescents With Prader-Willi Syndrome
Prader-Willi Syndrome (PWS) is one of the most common genetic causes of obesity. Obesity is a major source of morbidity and mortality in this population.
- Trial name
- NCT01444898
- Testing
- Exenatide
- Where
- United States
- Volunteers
- 10 people
- Sponsor
- Children's Hospital Los Angeles
Pain
Sub-dissociative Ketamine for the Management of Acute Pediatric Pain
The proposed trial is a prospective, double blinded, randomized control trial with the primary aim of determining whether a single, sub-dissociative dose of ketamine will decrease the total narcotic requirements of pediatric…
- Trial name
- NCT01951963
- Testing
- Ketamine, Morphine
- Where
- United States
- Volunteers
- 77 people
- Sponsor
- HealthPartners Institute
Purpura, Thrombocytopenic, Idiopathic
A Long-term Safety Study of Eltrombopag in Pediatric Patients With Chronic Immune (Idiopathic) Thrombocytopenic Purpura (ITP)
This was an open-label Phase III extension study to evaluate the long-term safety of eltrombopag in pediatric patients with chronic ITP who previously participated in study TRA115450.
- Trial name
- NCT02201290
- Testing
- Eltrombopag Tablets, Eltrombopag PfOS
- Where
- 3 sites in Russia
- Volunteers
- 9 people
- Sponsor
- Novartis Pharmaceuticals
Juvenile Idiopathic Arthritis
Open-label Safety and Pharmacokinetic Study of DUEXIS® (Ibuprofen and Famotidine) Tablets in Juvenile Idiopathic Arthritis
The primary objective of this Phase 4, multi-center, open-label study is to evaluate the safety and tolerability of DUEXIS in Juvenile Idiopathic Arthritis (JIA) patients aged 10 years to 16 years, 11 months, treated up to 24…
- Trial name
- NCT01563185
- Testing
- 800 mg ibuprofen/26.6 mg famotidine
- Where
- 5 sites in United States
- Volunteers
- 12 people
- Sponsor
- Amgen
Respiratory Failure
Trilogy Comparison Study - Pediatrics
The objective of this study (Part II) will be to compare the performance of the Trilogy device and a conventional ventilator (participant's current device).
- Trial name
- NCT00810459
- Testing
- Trilogy Ventilator, Standard of Care
- Where
- Canada
- Volunteers
- 6 people
- Sponsor
- Philips Respironics
Chemotherapy-induced Nausea and Vomiting
Olanzapine for Prevention of Chemotherapy-induced Nausea and Vomiting in Children: A Multi-Centre Feasibility Study
Olanzapine is licensed for use in adults in Canada and in teens in the US with mental illness. It is also often used for the management of mental illness in children.
- Trial name
- NCT02129478
- Testing
- Olanzapine
- Where
- 3 sites in Canada
- Volunteers
- 15 people
- Sponsor
- The Hospital for Sick Children