Clinical trials: Pediatric Safety and Effectiveness
Acute Stress Disorder, Anxiety
Safety & Efficacy of Intranasal Dexmedetomidine, Fentanyl & Midazolam in the Pediatric Emergency Room
The hypothesis is that intranasal dexmedetomidine will provide significantly more effective analgesia and anxiolysis for subjects undergoing a simple laceration repair when compared to either intranasal fentanyl or intranasal…
- Conditions
- Acute Stress Disorder, Anxiety, Pain
- Trial name
- NCT05057689
- Testing
- Intranasal Dexmedetomidine (4 mcg/kg), Intranasal Fentanyl (2 mcg/kg), Intranasal Midazolam (5 mg/kg)
- Where
- United States
- Volunteers
- healthy volunteers welcome
- Sponsor
- Nationwide Children's Hospital
Attention Deficit Hyperactivity Disorder (ADHD)
A Long Term Post-Marketing Study on the EffIcacy and Safety of Osmotic Release Oral System (OROS) Methylphenidate on the Cognitive Functions of Attention Deficit Hyperactivity Disorder (ADHD) Participants
The purpose of this long term post-marketing study is to evaluate the effectiveness and safety of osmotic release oral system methylphenidate hydrochloride (OROS-MPH) in participants with Attention Deficit Hyperactivity Disorder…
- Trial name
- NCT01933880
- Testing
- Osmotic Release Oral System Methylphenidate Hydrochloride (OROS-MPH), No intervention
- Where
- 6 sites in China
- Volunteers
- 194 people, healthy volunteers welcome
- Sponsor
- Xian-Janssen Pharmaceutical Ltd.
Tinea Corporis
Pediatric Subjects With Tinea Corporis
The study is being done to see how well the study cream works when applied once a day to affected area of child (where they have ringworm).
- Trial name
- NCT02227290
- Testing
- Naftin Cream
- Where
- 19 sites in United States, Dominican Republic and 3 more
- Volunteers
- 230 people, healthy volunteers welcome
- Sponsor
- Merz North America, Inc.
Bowel Preparation, Pediatric Colonoscopy
One-Day Versus Three-Day Bowel Preparation for Colonoscopy in Children
This was a blinded study conducted on the efficacy and safety of a one-day versus a three-day bowel preparation in a pediatric population.
- Trial name
- NCT02174497
- Where
- United States
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- St. John Health System, Michigan
Influenza, Human
Efficacy Study With QIVc in Pediatric Subjects
This phase 3 clinical study is a randomized, observer-blind, multicenter study of QIVc versus a non-influenza vaccine in subjects 6 months though 47 months of age.
- Trial name
- NCT03932682
- Testing
- QIVc, Comparator
- Where
- 74 sites in Bangladesh, Bulgaria and 13 more
- Volunteers
- 5,723 people, healthy volunteers welcome
- Sponsor
- Seqirus
Nasal Congestion
A Nasal Spray for Relief of Nasal Congestion in Infants and Toddlers With Common Cold
The study will evaluate the safety and efficacy of the study medical device plus standard of care versus standard of care in subjects between 3 and 48 months (inclusive) presenting symptoms of a common cold.
- Trial name
- NCT05365789
- Testing
- Blocked Nose Baby nasal spray, Standard of care
- Where
- Poland
- Volunteers
- 220 people, healthy volunteers welcome
- Sponsor
- Church & Dwight Company, Inc.
Sleep Apnea, Obstructive
Study of PROVIGIL ® (Modafinil) Treatment in Children and Adolescents With Excessive Sleepiness Associated With Obstructive Sleep Apnea/Hypopnea Syndrome
The primary objectives of the study are to determine the effectiveness of PROVIGIL treatment, compared to placebo treatment, in children and adolescents with excessive sleepiness (ES) associated with obstructive sleep…
- Trial name
- NCT00107809
- Testing
- Modafinil
- Where
- 64 sites in United States, Canada
- Volunteers
- 140 people, healthy volunteers welcome
- Sponsor
- Cephalon
Cough
Efficacy, Safety and Palatability of the Syrup "KalobaTuss® Children" for the Treatment of Cough in Children
Cough of children is one of the most frequent events for which parents ask for a medical consult and it is a true challenge for pediatrics during daily practice.
- Trial name
- KALOCOUGH (NCT04073251)
- Testing
- KalobaTuss children
- Where
- Italy
- Volunteers
- 106 people, healthy volunteers welcome
- Sponsor
- Azienda Ospedaliera Universitaria Policlinico "G. Martino"
Glycogen Storage Disease Type II-Pompe's Disease
A Study to Assess Safety and Efficacy of Avalglucosidase Alfa Administered Every Other Week in Pediatric Patients With Infantile-onset Pompe Disease Previously Treated With Alglucosidase Alfa
This is a multi-stage, phase 2, open-label, multicenter, multinational, ascending dose cohort, repeated intravenous (IV) infusion study of avalglucosidase alfa in pediatric patients with Infantile-Onset Pompe Disease (IOPD) who…
- Trial name
- Mini-COMET (NCT03019406)
- Testing
- Avalglucosidase alfa (GZ402666), Alglucosidase alfa (GZ419829)
- Where
- 12 sites in United States, France and 3 more
- Volunteers
- 22 people, healthy volunteers welcome
- Sponsor
- Genzyme, a Sanofi Company
Flat Warts, HIV
Acquired Epidermodysplasia Verruciformis (EV) Syndrome in HIV-infected Pediatric Patients
Many human immunodeficiency virus (HIV)-positive children are afflicted with diffuse flat warts that have been recalcitrant to multiple treatments.The aim of this prospective study was to evaluate the efficacy, safety and…
- Trial name
- NCT01289171
- Testing
- Glycolic acid
- Where
- Botswana
- Volunteers
- 38 people, healthy volunteers welcome
- Sponsor
- University of Pennsylvania
Atopic Dermatitis
Efficacy and Safety of IDP-124 Lotion for the Treatment of Moderate to Severe Atopic Dermatitis in Pediatric and Adult Subjects
Efficacy and Safety of IDP-124 Lotion for the Treatment of Moderate to Severe Atopic Dermatitis in Pediatric and Adult Subjects
- Trial name
- NCT03058783
- Testing
- IDP-124 Lotion, IDP-124 Vehicle Lotion
- Where
- United States
- Volunteers
- 328 people, healthy volunteers welcome
- Sponsor
- Bausch Health Americas, Inc.
Upper Respiratory Tract Infections
A Randomized, Double-blind, Placebo-controlled Study on the Efficacy and Safety of CVT-E002 in the Treatment of Upper Respiratory Tract Infections in a Pediatric (3-11 Years) Population
Parents with children aged 3-11 will participate in this study. About 500 children will take part in the study. We expect about half of those children will develop symptoms of a respiratory infection.
- Trial name
- NCT00965822
- Testing
- North American ginseng
- Where
- 4 sites in Canada
- Volunteers
- 293 people, healthy volunteers welcome
- Sponsor
- Afexa Life Sciences Inc
Safety and Efficacy of Intranasal Dexmedetomidine
Safety and Efficacy of Intranasal Dexmedetomidine
The aim of this study is to evaluate the efficacy and safety of intranasal dexmedetomidine when used in combination with oral midazolam and/or nitrous oxide for moderate sedation during pediatric outpatient dental procedures.
- Trial name
- NCT02985697
- Testing
- Dexmedetomidine, Midazolam Hydrochloride, Nitrous Oxide
- Where
- United States
- Volunteers
- 100 people, healthy volunteers welcome
- Sponsor
- Bon Secours Pediatric Dental Associates
Pupillary Dilation Effect During Cycloplegic Refraction
Comparing Efficacy and Safety of CTO0303 in Pediatric Subjects
This is a prospective randomized study compared with active control arm.
- Trial name
- NCT06609525
- Testing
- CTO0303-A, CTO0303-B, CTO0303-C
- Where
- South Korea
- Volunteers
- 156 people, healthy volunteers welcome
- Sponsor
- Taejoon Pharmaceutical Co., Ltd.
Atopic Dermatitis
Efficacy and Safety of IDP-124 Lotion for the Treatment of Moderate to Severe Atopic Dermatitis in Pediatric and Adult Subjects (301)
Efficacy and Safety of IDP-124 Lotion for the Treatment of Moderate to Severe Atopic Dermatitis in Pediatric and Adult Subjects
- Trial name
- NCT03002571
- Testing
- IDP-124 Lotion, IDP-124 Vehicle Lotion
- Where
- United States
- Volunteers
- 338 people, healthy volunteers welcome
- Sponsor
- Bausch Health Americas, Inc.
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
Functional Gastrointestinal Disorders
Effect of Fecal Microbiota Transplantation (FMT) in Pediatric Functional Gastrointestinal Disorders
Safety and efficacy of FMT in Pediatric Functional Gastrointestinal Disorders
- Trial name
- FGIDs (NCT05753774)
- Testing
- FMT, Conventional drugs
- Where
- China
- Volunteers
- 47 people, healthy volunteers welcome
- Sponsor
- Biao Zou
SARS-CoV Infection, Covid19
A Study to Evaluate the Efficacy, Immune Response, and Safety of a COVID-19 Vaccine in Adults ≥ 18 Years With a Pediatric Expansion in Adolescents (12 to<18 Years) at Risk for SARS-CoV-2
This is a phase 3, randomized, observer-blinded, placebo-controlled study to evaluate the efficacy, safety, and immunogenicity of SARS-CoV-2 rS with Matrix-M1 adjuvant in adult participants and adolescent participants.
- Trial name
- NCT04611802
- Testing
- SARS-CoV-2 rS/Matrix-M1 Adjuvant (Initial Vaccination Period), SARS-CoV-2 rS/Matrix-M1 Adjuvant (Crossover Vaccination period), SARS-CoV-2 rS/Matrix-M1 Adjuvant (Booster Vaccination)
- Where
- 154 sites in United States, Mexico and 1 more
- Volunteers
- 33,000 people, healthy volunteers welcome
- Sponsor
- Novavax
Heart Murmurs, Wheezing
Validate the Efficacy and the Safety of the Keikku Electronic Stethoscope for Its Indication and Intended Purpose, Under the Intended Conditions of Use.
This study is testing a digital stethoscope called the Keikku electronic stethoscope. Doctors use stethoscopes to listen to the heart, and this new device records heart sounds using a smartphone app.
- Trial name
- KCI-1 (NCT07044128)
- Testing
- Digital stethoscope using MEMS sensor and mobile application for cardiac auscultation
- Where
- Peru
- Volunteers
- 149 people, healthy volunteers welcome
- Sponsor
- Lapsi Health Holding B.V.
Anesthesia
Dose-Ranging Study of Intranasal Kovacaine Mist in Pediatric Subjects
The purpose of this study is to assess the efficacy and safety of intranasally administered Kovacaine Mist for anesthetizing maxillary teeth in pediatric subjects.
- Trial name
- NCT01701505
- Testing
- 400uL of Kovacaine Mist, 200uL of Kovacaine Mist, 120uL of Kovacaine Mist
- Where
- United States
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- St. Renatus, LLC