Clinical trials: Pediatrics
Hearing Loss
Innovations in Clinical Care of CE Approved Nucleus Cochlear Implant Recipients
This study is to evaluate new approaches to device fitting and diagnostics for cochlear implant users. The evaluation can be performed in the laboratory in an acute session or in real world environments with take-home device use…
- Trial name
- NCT05270876
- Testing
- Cochlear Implant and sound processor device fitting paradigm or diagnostic/measurement technique
- Where
- 5 sites in Australia, Belgium
- Volunteers
- 20 people
- Sponsor
- Cochlear
Depressive Disorder, Major Depressive Disorder
Study Evaluating Desvenlafaxine Succinate Sustained-Release Tablets (DVS SR) In The Treatment Of Child and Adolescent Outpatients With Major Depressive Disorder
The primary purpose of this study is to evaluate the long-term safety and tolerability of Desvenlafaxine Succinate Sustained-Release (DVS SR) in child and adolescent outpatients with major depressive disorder.
- Trial name
- NCT00669110
- Testing
- Desvenlafaxine Succinate Sustained-Release Tablets (DVS SR)
- Where
- 9 sites in United States
- Volunteers
- 40 people
- Sponsor
- Wyeth is now a wholly owned subsidiary of Pfizer
Hypertension
A Comparative Single-Dose Pharmacokinetic (PK) and Safety Study of Azilsartan Medoxomil in Children With Hypertension and in Healthy Adults
The purpose of this study was to assess the pharmacokinetics (PK) and safety of a single dose of azilsartan medoxomil in children with hypertension, and comparative PK in healthy adults.
- Trial name
- NCT01078376
- Testing
- Azilsartan medoxomil (TAK-491)
- Where
- 8 sites in United States, United Kingdom
- Volunteers
- 29 people, healthy volunteers welcome
- Sponsor
- Takeda
Reflux Esophagitis, Gastric Ulcer
A Study of Esomeplazole (D961H) in Japanese Paediatric Patients With Reflux Esophagitis, Gastric Ulcer or Duodenal Ulcer
This is an open label, parallel group, multi-centre, phase III study to assess the safety and efficacy of D961H in maintenance therapy following initial healing therapy in Japanese paediatric patients with reflux esophagitis, and…
- Conditions
- Reflux Esophagitis, Gastric Ulcer, Duodenal Ulcer
- Trial name
- NCT03553563
- Testing
- D961H capsule 10mg, D961H sachet 10mg
- Where
- 15 sites in Japan
- Volunteers
- 50 people
- Sponsor
- AstraZeneca
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
Acute Otitis Media, Acute Sinusitis
Comparative Effectiveness of Antibiotics for Respiratory Infections
The purpose of this study is to identify and use patient centered outcomes to compare narrow-spectrum and broad-spectrum antibiotics for the treatment of common acute respiratory tract infections (ARTIs) in children.
- Conditions
- Acute Otitis Media, Acute Sinusitis, Group A Streptococcal Pharyngitis
- Trial name
- CEARI (NCT02297815)
- Testing
- Broad-spectrum antibiotics, Narrow-spectrum antibiotics
- Where
- United States
- Volunteers
- 2,472 people
- Sponsor
- Children's Hospital of Philadelphia
Inborn Errors of Bile Acid Synthesis
Efficacy of To Be Marketed (TBM) Cholic Acid Capsules Used to Treat Children With Inborn Errors of Bile Acid Synthesis
This is a study in a small population of children who have inborn errors of bile acid synthesis who are currently taking established doses of the currently used cholic acid capsules prepared at the Cincinnati Children's Hospital…
- Trial name
- NCT01115582
- Testing
- Cholic acid
- Where
- United States
- Volunteers
- 16 people
- Sponsor
- Mirum Pharmaceuticals, Inc.
Hypertension
Dose Response of Valsartan on Sitting Systolic Blood Pressure in Children 6 Months - 5 Years of Age With High Blood Pressure
The purpose of this study is to evaluate the safety and efficacy of three doses of valsartan (0.25, 1.0, and 4.0 mg/kg) on mean sitting systolic blood pressure (MSSBP) and mean sitting diastolic blood pressure (MSDBP) in 6 months…
- Trial name
- NCT00435162
- Testing
- Valsartan 0.25 mg/kg, Valsartan 1.0 mg/kg, Valsartan 4.0 mg/kg
- Where
- 11 sites in United States, Belgium and 9 more
- Volunteers
- 74 people
- Sponsor
- Novartis Pharmaceuticals
High Grade Glioma
A Study of Bevacizumab (Avastin) in Combination With Temozolomide (TMZ) and Radiotherapy in Paediatric and Adolescent Participants With High-Grade Glioma
This randomized, open-label, multicenter, 2-arm study will investigate the efficacy, safety, tolerability and pharmacokinetics of bevacizumab when added to postoperative radiotherapy with concomitant and adjuvant TMZ as compared…
- Trial name
- NCT01390948
- Testing
- Bevacizumab, Radiotherapy, Temozolomide (TMZ)
- Where
- 53 sites in Australia, Austria and 12 more
- Volunteers
- 124 people
- Sponsor
- Hoffmann-La Roche
Helminthes; Infestation, Intestinal
Evaluation of Effectiveness of ALBENDAZOLIVERMECTIN Coformulation vs ALBENDAZOLE for Treatment of Intestinal Worms
The purpose of this clinical trial is to evaluate a fixed-dose co-formulation (FDC) of ivermectin and albendazole for the treatment of all Soil Transmitted helminths (STH).
- Trial name
- ALIVE (NCT05124691)
- Testing
- Albendazole and Ivermectin fixed dose coformulation, Albendazole
- Where
- 3 sites in Ethiopia, Kenya and 1 more
- Volunteers
- 1,001 people
- Sponsor
- Barcelona Institute for Global Health
Amblyopia, Strabismus
Improving Quality Vision Outcomes in Managed Care Setting While Reducing Cost by Use of Accurate, Automated Screening
Amblyopia ("lazy eye") and strabismus (misaligned eyes) are medical eye conditions that combine as the leading causes of preventable vision loss in children.
- Trial name
- NCT02536963
- Testing
- Pediatric Vision Scanning device, Reference examination
- Where
- United States
- Volunteers
- 318 people, healthy volunteers welcome
- Sponsor
- Rebiscan, Inc.
Virtual Reality, Pediatrics
Virtual Reality During Procedures in Pediatric Patients
This stratified, randomized, controlled trial compared coping and distress between child life supported virtual reality engagement and child life support during painful procedures in the pediatric emergency department.
- Trial name
- NCT03686176
- Testing
- Virtual Reality
- Where
- United States
- Volunteers
- 64 people, healthy volunteers welcome
- Sponsor
- Johns Hopkins University
Thrombosis, Heparin-induced Thrombocytopenia
Pilot Dose Finding and Pharmacokinetic Study of Fondaparinux in Children With Thrombosis
This study will evaluate the use of a blood thinner, fondaparinux, which is approved for use in adults (not in children) in a children aged 1-18 years.
- Trial name
- NCT00412464
- Testing
- Fondaparinux
- Where
- 4 sites in United States
- Volunteers
- 24 people
- Sponsor
- Children's Hospital Los Angeles
Partial-Onset or Primary Generalized Tonic-Clonic Seizures
Perampanel as Adjunctive Therapy in Pediatrics With Partial Onset Seizures or Primary Generalized Tonic Clonic Seizures
This is an open-label, multicenter study with an Extension Phase to evaluate the safety and tolerability of perampanel oral suspension when administered as an adjunctive therapy in children (ages 4 to less than [<] 12 years) with…
- Trial name
- NCT02849626
- Testing
- Perampanel
- Where
- 91 sites in United States, Belgium and 10 more
- Volunteers
- 180 people
- Sponsor
- Eisai Inc.
Pain, Nausea
Optimal Dose of Prophylactic Naloxone in Reducing Opioid-Induced Side Effects in Children/Adolescents
This is an investigator initiated dose finding study designed to determine the optimal dose of naloxone to prevent or minimize the most common side effects induced by opioids, namely itching, nausea, and vomiting.
- Conditions
- Pain, Nausea, Pruritus
- Trial name
- NCT00330343
- Testing
- naloxone
- Where
- United States
- Volunteers
- 75 people
- Sponsor
- Johns Hopkins University
Fabry Disease
Replagal Enzyme Replacement Therapy for Children With Fabry Disease
Primary Objective(s): To assess the safety of Replagal at a dose of 0.2 mg/kg administered over 40 (+/-10) minutes in children with Fabry disease To assess the effect of Replagal on heart rate variability in patients 7 to 17…
- Trial name
- NCT00084084
- Testing
- Agalsidase alfa
- Where
- 14 sites in United States, Canada
- Volunteers
- 17 people
- Sponsor
- Shire
Cancer
Adult and Paediatric Patient Radiation Doses From Multidetector Row Computed Tomography Scans: a National Survey
The situation in Italy regarding radiation dose to patients undergoing Multidetector row Computed Tomography (MDCT) scans is unclear despite Italian law require that each centre check the Reference Dose Level (RDL) every two…
- Trial name
- MDCTDOSE (NCT01436006)
- Where
- Italy
- Volunteers
- 6,700 people
- Sponsor
- University of Palermo
Pediatric Perioperative Blood Pressure Management
Assessment of Efficacy, Safety and Dosing of Clevidipine in Pediatric Participants Undergoing Surgery (PIONEER)
Evaluate the efficacy, safety, and dosing of clevidipine as an intravenous (IV) infusion for blood pressure (BP) management in paediatric participants in the perioperative setting.
- Trial name
- PIONEER (NCT01938547)
- Testing
- clevidipine
- Where
- 2 sites in United States
- Volunteers
- 22 people
- Sponsor
- Chiesi Farmaceutici S.p.A.
Hypertension
A Study to Evaluate the Long-term Use of Valsartan in Children 6 Months to 5 Years Old With Hypertension
The purpose of this study is to evaluate the efficacy, safety and tolerability of long-term use (up to 18 weeks) of valsartan in children 6 months to 5 years old with hypertension.
- Trial name
- NCT00457626
- Testing
- Valsartan
- Where
- 36 sites in United States, Belgium and 8 more
- Volunteers
- 66 people
- Sponsor
- Novartis Pharmaceuticals
HIV-1 Infection
Rollover Study Protocol for Pediatric Patients in South Africa for Continued Access to Emtricitabine
The primary objectives of this trial are to provide FTC-203 study participants in South Africa with continued access to the study drug, emtricitabine (FTC), following completion of the FTC-203 study and to collect long-term…
- Trial name
- NCT00743340
- Testing
- Emtricitabine
- Where
- 2 sites in South Africa
- Volunteers
- 50 people
- Sponsor
- Gilead Sciences