Clinical trials: Pediatric Safety and Effectiveness
Cancer Harboring BRAF Alterations, HGG
A Study to Assess the Efficacy and Safety of FORE8394 in Participants With Cancer Harboring BRAF Alterations
The objective of this Master Protocol is to evaluate the efficacy and safety of plixorafenib in participants with BRAF altered (BRAF V600E or BRAF fusions) locally advanced or metastatic solid tumors, or recurrent or progressive…
- Conditions
- Cancer Harboring BRAF Alterations, HGG, LGG, Solid Tumors
- Trial name
- NCT05503797
- Testing
- Plixorafenib
- Where
- 70 sites in United States, Australia and 10 more
- Volunteers
- 254 people
- Sponsor
- Fore Biotherapeutics
Attention Deficit Hyperactivity Disorder (ADHD)
Treatment of Impulsive Aggression in Subjects With ADHD in Conjunction With Standard ADHD Treatment (CHIME 1)
The purpose of this study is to demonstrate the efficacy, safety, and tolerability of SPN-810 in the treatment of Impulsive Aggression (IA) in subjects with Attention-Deficit/Hyperactivity Disorder (ADHD) in conjunction with…
- Trial name
- NCT02618408
- Testing
- SPN-810 (18 mg), SPN-810 (36 mg)
- Where
- 28 sites in United States
- Volunteers
- 333 people
- Sponsor
- Supernus Pharmaceuticals, Inc.
Liver Transplantation, Infection
Efficacy and Safety of Basiliximab, Cyclosporine/Cyclosporine Microemulsion, and Steroids in Pediatric de Novo Liver Transplant Recipients Avoiding Intraoperative Steroids
Systemic infection is still a major concern in young children with liver transplantation. The approach of this study is to reduce the risk of systemic infections by avoiding intraoperative steroids (another class of…
- Trial name
- NCT00149890
- Testing
- Basiliximab, Cyclosporine/cyclosporine microemulsion, Steroid
- Where
- Germany
- Volunteers
- 77 people
- Sponsor
- Novartis
Acute Pain
A Study to Look at Tapentadol Oral Solution in Children and Adolescents in Pain
The purpose of the study was to evaluate the efficacy of tapentadol oral solution, based on the total amount of supplemental opioid analgesic used over 12 hours or 24 hours after initiation of investigational medicinal product…
- Trial name
- NCT02081391
- Testing
- Tapentadol oral solution 4 mg/mL, Tapentadol oral solution 20 mg/mL
- Where
- 43 sites in United States, Bulgaria and 8 more
- Volunteers
- 216 people
- Sponsor
- Grünenthal GmbH
Plaque Psoriasis
Plaque Psoriasis Study in Pediatric Subjects
The purpose of this study is to compare the safety, efficacy and calcium metabolism of up to 8 weeks of treatment with calcitriol 3 mcg/g ointment versus its vehicle, when used twice daily, without occlusion, to treat children…
- Trial name
- NCT02186665
- Testing
- calcitriol ointment
- Where
- 34 sites in United States, Belgium and 5 more
- Volunteers
- 19 people
- Sponsor
- Galderma R&D
Chronic Sinusitis
Safety and Efficacy of Balloon Sinuplasty in Pediatric Sinusitis
A non-randomized, multi-center, prospective, clinical study intended to evaluate the safety and efficacy of balloon sinuplasty devices in pediatric patients with longstanding sinusitis following failed medical management.
- Trial name
- INTACT (NCT00939471)
- Testing
- Relieva™ Balloon Sinuplasty™ System
- Where
- United States
- Volunteers
- 44 people
- Sponsor
- Integra LifeSciences Corporation
Iron Deficiency Anemia
Multicenter Randomized Active-controlled Study to Investigate Efficacy & Safety of IV FCM in Pediatric Patients With IDA
The primary objective of this study is to demonstrate the efficacy and safety of intravenous ferric carboxymaltose (FCM), compared to oral iron, in pediatric participants who have iron deficiency anemia.
- Trial name
- NCT03523117
- Testing
- Ferric carboxymaltose, Ferrous Sulfate
- Where
- 16 sites in United States
- Volunteers
- 79 people
- Sponsor
- American Regent, Inc.
Ventricular Dysfunction, Ventricular Dysfunction, Left
Registry to Monitor Berlin Heart EXCOR® Pediatric VAD as a Bridge to Cardiac Transplantation.
The purpose of this post market surveillance is to continue monitoring the safety and effectiveness of the Berlin Heart EXCOR® Pediatric.
- Conditions
- Ventricular Dysfunction, Ventricular Dysfunction, Left, Ventricular Dysfunction, Right
- Trial name
- NCT03701997
- Testing
- EXCOR Pediatric
- Where
- United States
- Volunteers
- 62 people
- Sponsor
- Berlin Heart, Inc
Warts
An up to Twelve Week Safety and Efficacy Study With a Topical Gel to Treat Common Warts in Pediatric Subjects
The primary purpose of this study is to evaluate the effectiveness in pediatric subjects of three different strengths of resiquimod gel applied to common wart(s) three times a week for up to twelve weeks.
- Trial name
- NCT00116662
- Testing
- Resiquimod
- Where
- 10 sites in United States
- Volunteers
- 84 people
- Sponsor
- Graceway Pharmaceuticals, LLC
Food Allergy
Efficacy and Safety of Low-dose Sesame Oral Immunotherapy in Pediatric Patients
It is a randomized, single-center, controlled trial to evaluate the effectiveness of oral immunotherapy with low-dose sesame protein compared with standard treatment (elimination diet) in patients with sesame allergy.
- Trial name
- NCT06261554
- Testing
- Dietary Supplement: Low dose OIT
- Where
- Poland
- Volunteers
- 39 people
- Sponsor
- Medical University of Warsaw
Precursor Cell Lymphoblastic Leukemia-Lymphoma, Lymphoma, Non-Hodgkin
A Study to Evaluate the Safety and Efficacy of JCAR017 in Pediatric Subjects With Relapsed/Refractory (r/r) B-cell Acute Lymphoblastic Leukemia (B-ALL) and B-cell Non-Hodgkin Lymphoma (B-NHL)
This is a Phase 1/2, open-label, single arm, multicohort study to evaluate the safety and efficacy of JCAR017 in pediatric subjects aged ≤ 25 years with CD19+ r/r B-ALL and B-NHL.
- Trial name
- NCT03743246
- Testing
- JCAR017, Lymphodepleting, Fludarabine
- Where
- 19 sites in United States, France and 4 more
- Volunteers
- 21 people
- Sponsor
- Celgene
Asthma
Efficacy and Safety of Ciclesonide (CIC) Administered Twice Daily in Pediatric Patients With Asthma.
Primary objective: To demonstrate the efficacy of ciclesonide, compared to placebo, at 80 μg twice daily (BID) or 40 μg BID for 12 weeks in patients with persistent asthma.
- Trial name
- NCT00392288
- Testing
- Ciclesonide
- Where
- 6 sites in United States, Hungary and 4 more
- Volunteers
- 528 people
- Sponsor
- AstraZeneca
Crohn Disease
A Study of Efficacy and Safety of Mongersen (GED-0301) for the Treatment of Adult and Adolescent Subjects With Active Crohn's Disease
The purpose of study is to test the effect of an experimental medication GED-0301(mongersen) and evaluate its safety in patients (≥ 12 years of age) with active Crohn's disease.
- Trial name
- NCT02974322
- Testing
- GED-0301
- Where
- 311 sites in United States, Australia and 28 more
- Sponsor
- Celgene
Sialorrhea
Efficacy and Safety Study of MYOBLOC in the Treatment of Sialorrhea in Pediatric Subjects
This study will evaluate the efficacy and safety of MYOBLOC for the treatment of chronic sialorrhea in pediatric subjects.
- Trial name
- NCT05097079
- Testing
- MYOBLOC Low Dose, MYOBLOC High Dose
- Sponsor
- Solstice Neurosciences, LLC, a subsidiary of MDD US Operations, LLC
Autistic Spectrum Disorders
TSO in Pediatric Autistic Spectrum Disorders
The primary objective of this study is to evaluate and compare the safety and efficacy of Trichuris suis ova (TSO) therapy (versus placebo) in pediatric patients with autism.
- Trial name
- TSO (NCT01734941)
- Testing
- TSO
- Where
- Israel
- Volunteers
- 9 people
- Sponsor
- Hadassah Medical Organization
Colchicine Resistant/Intolerant Familial Mediterranean Fever
Evaluate the Safety and Efficacy of Canakinumab in Pediatric Patients With Colchicine Intolerant or Colchicine Resistant Familial Mediterranean Fever (FMF)
A study designed to evaluate the role of treatment with a biological agent - Canakinumab in pediatric (age 4-20) Familial Mediterranean Fever (FMF) patients that are intolerant or resistant for colchicine treatment.
- Trial name
- CONTROL FMF (NCT01148797)
- Testing
- Canakinumab
- Where
- 5 sites in Israel
- Volunteers
- 15 people
- Sponsor
- Novartis Pharmaceuticals
Hypertension
An Extension Study to Evaluate the Long Term Safety, Tolerability and Efficacy of Aliskiren Compared to Enalapril in Pediatric Hypertensive Patients 6-17 Years of Age
The purpose of this study is to evaluate in a randomized, double-blind fashion, the long-term safety, tolerability and efficacy profile of aliskiren compared to the active comparator enalapril in children, 6 - 17 years old with…
- Trial name
- NCT01151410
- Testing
- Aliskiren, Enalapril
- Where
- 36 sites in United States, Guatemala and 5 more
- Volunteers
- 208 people
- Sponsor
- Novartis Pharmaceuticals
Alpha-Mannosidosis
Trial on Safety and Efficacy of Velmanase Alfa Treatment in Pediatric Patients With Alpha-Mannosidosis
The main objectives of the study are to evaluate safety and efficacy of repeated treatment with recombinant human alfa-mannosidase of patients with alfa-mannosidosis aged less than 6 years
- Trial name
- rhLaman-08 (NCT02998879)
- Testing
- Velmanase Alfa (e.g. Lamazym)
- Where
- 6 sites in Austria, Denmark and 3 more
- Volunteers
- 5 people
- Sponsor
- Chiesi Farmaceutici S.p.A.
Schizophrenia, Affective Disorders
Safety And Efficacy Study Of Ziprasidone In Pediatric Psychotic Illness
The purpose of this research is to determine if Ziprasidone is safe and effective for use in children and adolescents with a psychotic illness, and to determine of Ziprasidone treatment leads to weight changes in children.
- Conditions
- Schizophrenia, Affective Disorders, Psychotic Disorder, Psychotic Mood Disorder
- Trial name
- NCT00199940
- Testing
- Ziprasidone
- Volunteers
- 20 people
- Sponsor
- Medical College of Wisconsin
Anatomic Stage III Breast Cancer AJCC v8, Anatomic Stage IV Breast Cancer AJCC v8
Testing the Safety and Efficacy of the Combination of Two Anti-cancer Drugs, ZEN003694 and Abemaciclib, for Adult and Pediatric Patients (12-17 Years) With Metastatic or Unresectable NUT Carcinoma, Breast Cancer and Other Solid Tumors
This phase I trial tests the safety, side effects, and best dose of ZEN003694 when given together with abemaciclib in treating patients with NUT carcinoma, breast cancer or other solid tumors that have spread from where it first…
- Conditions
- Anatomic Stage III Breast Cancer AJCC v8, Anatomic Stage IV Breast Cancer AJCC v8, Metastatic Breast Carcinoma, Metastatic Malignant Solid Neoplasm
- Trial name
- NCT05372640
- Testing
- Abemaciclib, BET Bromodomain Inhibitor ZEN-3694, Biopsy Procedure
- Where
- 7 sites in United States
- Volunteers
- 45 people
- Sponsor
- National Cancer Institute (NCI)
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