Clinical trials: Pediatric Disorder
Amplified Musculoskeletal Pain Syndrome, Reflex Sympathetic Dystrophy
Audio-Visual Relaxation Technology for Pediatric Amplified Musculoskeletal Pain Syndrome
A pilot randomized controlled trial to assess feasibility, acceptability and generate outcome domains for a future RCT testing the efficacy of immersive virtual reality on pain intensity in pediatric amplified musculoskeletal…
- Conditions
- Amplified Musculoskeletal Pain Syndrome, Reflex Sympathetic Dystrophy, Complex Regional Pain Syndromes
- Trial name
- NCT03762213
- Testing
- Oculus GO VR HMD, application Happy Place (© Mimerse), iPad, application Happy Place (© Mimerse)
- Where
- United States
- Volunteers
- 30 people
- Sponsor
- Tufts Medical Center
Allergies
Multi-center, Pediatric, Open-label, Preference Study of Desloratadine 2.5 mg Reditab (SCH34117) and Zyrtec 5.0 mg Chewable Tablet Medications (Study P04574)(COMPLETED)
This was a randomized, open-label, 2-way cross-over study, comparing desloratadine RediTab 2.5 mg to a marketed chewable antihistamine oral medication (Zyrtec® 5 mg Chewable Tablet).
- Trial name
- NCT00779116
- Testing
- Desloratadine, Zyrtec® (cetirizine)
- Volunteers
- 217 people, healthy volunteers welcome
- Sponsor
- Organon and Co
Epilepsy
Open-Label PoC Trial of Ganaxolone in Children With PCDH19 Female Pediatric Epilepsy and Other Rare Genetic Epilepsies
To evaluate the efficacy of open-label ganaxolone as adjunctive therapy for uncontrolled seizures in female children with PCDH19 mutation and other rare genetic epilepsies in an open-label proof-of-concept study.
- Trial name
- NCT02358538
- Testing
- Ganaxolone
- Where
- 10 sites in United States, Italy
- Volunteers
- 30 people
- Sponsor
- Marinus Pharmaceuticals
Childhood Obesity
Summer Harvest Adventure: A Garden-based Obesity Prevention Program for Children Residing in Low-resource Communities
The objective of this study is to implement and test the efficacy of the "Summer Harvest Adventure," a comprehensive garden-based behavioral, social, and environmental intervention for children (ages 8-11 years) residing in…
- Trial name
- SHA (NCT05367674)
- Testing
- Summer Harvest Adventure, My Summer Plate (MSP)
- Where
- United States
- Volunteers
- 192 people, healthy volunteers welcome
- Sponsor
- Ohio State University
Malaria
Pyronaridine Artesunate 3:1 Granule Formulation vs. Coartem© Crushed Tablets in P. Falciparum Malaria Pediatric Patients
The primary objective of this Phase III clinical study is to demonstrate the efficacy of the fixed combination of pyronaridine artesunate (PA) granule formulation (60:20 mg; pediatric PYRAMAX®) by showing a PCR-corrected adequate…
- Trial name
- NCT00541385
- Testing
- pyronaridine artesunate, arthemeter lumefantrine
- Where
- 8 sites in Burkina Faso, Côte d’Ivoire and 6 more
- Volunteers
- 535 people
- Sponsor
- Medicines for Malaria Venture
Vitamin D Deficiency, Thoracic Surgery
Prevention of Vitamin D Deficiency Following Pediatric CHD Surgery: a Phase II Dose Evaluation Randomized Controlled Trial Comparing Usual Care With a High Dose Pre-operative Supplementation Regimen Based on the Institute of Medicine Daily Upper Tolerable Intake Level
Our research group has shown that almost all children with congenital heart disease (CHD) are vitamin D deficient following heart surgery.
- Conditions
- Vitamin D Deficiency, Thoracic Surgery, Pediatric Disorders, Heart Defects, Congenital
- Trial name
- HICCUPS 2 (NCT01838447)
- Testing
- Cholecalciferol
- Where
- Canada
- Volunteers
- 46 people
- Sponsor
- Children's Hospital of Eastern Ontario
Plexiform Neurofibroma, Neurofibromatosis Type 1 (NF1)
MEK Inhibitor Mirdametinib (PD-0325901) in Patients With Neurofibromatosis Type 1 Associated Plexiform Neurofibromas
This study evaluates mirdametinib (PD-0325901) in the treatment of symptomatic inoperable neurofibromatosis type-1 (NF1)-associated plexiform neurofibromas (PNs). All participants will receive mirdametinib (PD-0325901).
- Trial name
- ReNeu (NCT03962543)
- Testing
- Mirdametinib (PD-0325901) oral capsule or dispersible tablet
- Where
- 43 sites in United States
- Volunteers
- 114 people
- Sponsor
- SpringWorks Therapeutics, Inc., a healthcare company of Merck KGaA, Darmstadt, Germany
Spinal Cord Injury
The Effect of FES on Children With Spinal Cord Injury
Regular exercise is strongly recommended to help maintain a healthy lifestyle. Unfortunately, children and young adults with damaged spinal cords may not be able to exercise regularly.
- Trial name
- NCT00291317
- Testing
- RT 300-P FES Cycle
- Volunteers
- 6 people, healthy volunteers welcome
- Sponsor
- Children's Specialized Hospital
Chronic Hepatitis B
Safety and Efficacy of Adefovir Dipivoxil in Children and Adolescents With Chronic Hepatitis B
The purpose of this study is to investigate the efficacy and safety of adefovir dipivoxil for the treatment of chronic hepatitis B in children and adolescents (age 2 to less than 18 years) following 48 weeks of…
- Trial name
- NCT00095121
- Testing
- Adefovir Dipivoxil (ADV), Lamivudine
- Where
- United States
- Volunteers
- 173 people
- Sponsor
- Gilead Sciences
Congenital Heart Defect
Erythropoietin and Pediatric Cardiac Surgery
Lack of bloodflow to the heart and brain when the heart is stopped during heart surgery can cause damage to those organs. We hypothesize that a single dose of erythropoietin prior to the heart bypass portion of surgery may…
- Trial name
- EPO (NCT00451698)
- Testing
- acyanotic erythropoietin
- Where
- United States
- Volunteers
- 9 people
- Sponsor
- Medical College of Wisconsin
Narcolepsy With Cataplexy, Narcolepsy Without Cataplexy
Efficacy and Safety of Pitolisant in Pediatric Narcoleptic Patients With or Without Cataplexy, Double-blind Study Followed by a Prolonged Open-label Period
The purpose of this multicenter double blind study is to assess efficacy and safety of Pitolisant versus placebo in paediatric Narcoleptic patients with or without cataplexy.
- Trial name
- NCT02611687
- Testing
- pitolisant
- Where
- 11 sites in Finland, France and 3 more
- Volunteers
- 110 people
- Sponsor
- Bioprojet
Cerebral Edema, Diabetic Ketoacidosis
Randomized Control Trial of Fluid Therapy for Pediatric Diabetic Ketoacidosis
The investigators will conduct a randomized controlled trial comparing four different intravenous (IV) fluid treatment protocols for pediatric diabetic ketoacidosis (DKA).
- Trial name
- NCT01365793
- Testing
- 0.45% saline replacement fluid, 0.9% saline replacement fluid, 0.45% saline intravenous fluid
- Where
- 13 sites in United States
- Volunteers
- 1,389 people
- Sponsor
- University of California, Davis
Neutropenia
Safety and Pharmacokinetics of Intravenous and Oral Posaconazole in Immunocompromised Children (MK-5592-097)
This study aims to evaluate the pharmacokinetics of posaconazole (POS) administered intravenously (IV) or orally to immunocompromised pediatric participants.
- Trial name
- NCT02452034
- Testing
- Posaconazole IV solution, Posaconazole powder for oral suspension
- Volunteers
- 118 people
- Sponsor
- Merck Sharp & Dohme LLC
Non Alcoholic Steatohepatitis
Elafibranor, PK and Safety in Children and Adolescents 8 to 17 Years of Age With Non Alcoholic Steatohepatitis (NASH)
The study was being conducted in order to assess the pharmacokinetics and the safety of elafibranor following once daily administration of two dose levels of elafibranor (80 milligrams [mg] and 120mg) during 3 months in children…
- Trial name
- NCT03883607
- Testing
- Elafibranor 80mg, Elafibranor 120mg
- Where
- 2 sites in United States
- Volunteers
- 10 people
- Sponsor
- Genfit
Type1 Diabetes
Hybrid Closed Loop Therapy and Verapamil for Beta Cell Preservation in New Onset Type 1 Diabetes
Randomized trial of youth aged 7-<18 years with newly diagnosed stage 3 type 1 diabetes (T1D) to assess the effect of both (1) near-normalization of glucose concentrations achieved through use of a hybrid closed loop (HCL) system…
- Trial name
- CLVer (NCT04233034)
- Testing
- HCL, verapamil 120mg tablet, non-HCL
- Where
- 6 sites in United States
- Volunteers
- 113 people
- Sponsor
- Jaeb Center for Health Research
Thrombosis
Pharmacokinetic, Pharmacodynamic, Safety, and Efficacy Study of Rivaroxaban for Thromboprophylaxis in Pediatric Participants 2 to 8 Years of Age After the Fontan Procedure
The Purpose of this study is to characterize the single and multiple-dose pharmacokinetic (PK) and pharmacokinetic/pharmacodynamic (PK/ PD) profiles after oral rivaroxaban therapy administered to pediatric participants 2 to 8…
- Trial name
- UNIVERSE (NCT02846532)
- Testing
- Rivaroxaban, Acetylsalicylic Acid
- Where
- 42 sites in United States, Argentina and 8 more
- Volunteers
- 112 people
- Sponsor
- Janssen Research & Development, LLC
Head Injury
Shared Decision Making in Parents of Children With Head Trauma: Head CT Choice
The investigators will test the impact of a decision aid, Head CT Choice, to determine if its use improves parents' knowledge and engagement in decision making and safely decreases healthcare utilization in children presenting to…
- Trial name
- NCT02063087
- Testing
- Head CT Decision Aid
- Where
- 7 sites in United States
- Volunteers
- 971 people
- Sponsor
- Mayo Clinic
Vitamin D Deficiency
Safety, Efficacy, and Feasibility of High-dose Cholecalciferol in Pediatric Patients With Cystic Fibrosis
Children with Cystic Fibrosis, ages greater than and equal to 36 months of age and less than or equal to 18 years of age, with a 25OHD level less than 30 ng/dL will be asked to participate in this study.
- Trial name
- NCT02613884
- Testing
- Treatment
- Where
- United States
- Volunteers
- 26 people, healthy volunteers welcome
- Sponsor
- Johns Hopkins All Children's Hospital
Hypothyroidism
Thyroid Function of Pediatric Subjects Following Isovue® Administration
This is a Phase IV prospective, multicenter, observational study to estimate the proportion of subjects 0 to 3 years of age who develop abnormal thyroid function after exposure to intravascular administration of ISOVUE for the…
- Trial name
- NCT03779906
- Testing
- Isovue
- Where
- 4 sites in United States
- Volunteers
- 17 people
- Sponsor
- Bracco Diagnostics, Inc
Pediatric Glaucoma, Elevated IOP in Pediatric Patients
Study of Travoprost Ophthalmic Solution, 0.004% Compared to Timolol (0.5% or 0.25%) in Pediatric Glaucoma Patients
The purpose of this study is to evaluate the intraocular pressure (IOP)-lowering efficacy of Travoprost 0.004% POLYQUAD (PQ) ophthalmic solution compared to Timolol ophthalmic solution (0.5% or 0.25%) in pediatric glaucoma…
- Conditions
- Pediatric Glaucoma, Elevated IOP in Pediatric Patients, Ocular Hypertension in Pediatric Patients
- Trial name
- NCT01652664
- Testing
- Travoprost 0.004% PQ ophthalmic solution, Timolol, 0.5% or 0.25% ophthalmic solution, Travoprost Vehicle
- Volunteers
- 184 people
- Sponsor
- Alcon Research