Clinical trials: Pediatric ALL
Hypoplastic Left Heart Syndrome
The CHILD Trial: Hypoplastic Left Heart Syndrome Study.
The objectives of this pilot study are to evaluate the feasibility and safety of intramyocardial injection of autologous c-kit+ cells during the Stage II Bidirectional Cavopulmonary Anastomosis (BDCPA) operation and to observe…
- Trial name
- CHILD (NCT03406884)
- Testing
- c-kit+ cells
- Where
- 4 sites in United States
- Volunteers
- 25 people
- Sponsor
- Joshua M Hare
Leukemia
Study of Bendamustine Hydrochloride for the Treatment of Pediatric Patients With Relapsed or Refractory Acute Leukemia
The primary objective of phase 1 of this study is to establish the recommended phase II dose (RP2D). The primary objective of phase 2 of this study is to evaluate the safety and efficacy of bendamustine at the recommended…
- Trial name
- NCT01088984
- Testing
- Bendamustine
- Where
- 50 sites in United States, Australia and 10 more
- Volunteers
- 43 people
- Sponsor
- Teva Branded Pharmaceutical Products R&D, Inc.
Pain, Postoperative
Study of Diclofenac Capsules to Treat Pain Following Surgery in Children Ages 6 to <17 Years of Age
The purposes of this study are to evaluate the safety and tolerability and to model the single-dose pharmacokinetic profile of diclofenac capsules low dose and high dose in children ages 6 to <17 years experiencing mild to…
- Trial name
- NCT02424578
- Testing
- Diclofenac Capsules low dose, Diclofenac Capsules high dose
- Where
- 5 sites in United States
- Volunteers
- 30 people
- Sponsor
- Iroko Pharmaceuticals, LLC
SARS-CoV-2, COVID-19
Special Investigation for Booster Dose of Comirnaty in Children Ages 6 Months Though 4 Years
The purpose of this post-marketing study is to assess the safety of Comirnaty monovalent XBB.1.5. for booster vaccination children ages 6 months though 4 years under actual use medical practice.
- Trial name
- NCT06130410
- Testing
- COMIRNATY intramuscular injection
- Where
- Japan
- Volunteers
- 25 people, healthy volunteers welcome
- Sponsor
- Pfizer
Gliomas, Medulloblastoma
Phase I/II: Decitabine/Vaccine Therapy in Relapsed/Refractory Pediatric High Grade Gliomas/Medulloblastomas/CNS PNETs
The main purpose of this study is to determine the safety of using the combination of decitabine and a cancer vaccine plus Hiltonol.
- Conditions
- Gliomas, Medulloblastoma, Neuroectodermal Tumors, Primitive
- Trial name
- NCT02332889
- Testing
- Vaccine (autologous dendritic cells), Decitabine and Hiltonol
- Where
- 3 sites in United States
- Volunteers
- 1 people
- Sponsor
- University of Louisville
Community-acquired Pneumonia (CAP), Hospital-acquired Pneumonia (HAP)
Ceftobiprole in the Treatment of Pediatric Patients With Pneumonia
This was a study of the safety and efficacy of ceftobiprole medocaril compared with intravenous (IV) standard-of-care cephalosporin treatment with or without vancomycin in pediatric patients with either hospital-acquired…
- Trial name
- NCT03439124
- Testing
- ceftobiprole medocaril, IV standard-of-care cephalosporin
- Where
- 19 sites in Bulgaria, Georgia and 2 more
- Volunteers
- 138 people
- Sponsor
- Basilea Pharmaceutica
Deformity, Defect, Congenital
Observational Study on JuniOrtho Plating System for Deformities and Fractures Treatment in Lower Limb
Orthofix Srl put the JPS on the European market (2019) by the mean of a pre-market clinical evaluation made under the Medical Device Directive (MDD) requirements that were based on the analysis of the scientific literature of…
- Conditions
- Deformity, Defect, Congenital, Trauma
- Trial name
- JPS (NCT05245617)
- Testing
- JuniOrtho™ Plating System™
- Where
- Germany
- Volunteers
- 30 people
- Sponsor
- Orthofix s.r.l.
Cardiac Surgery, Cardiopulmonary Bypass
Colloids in Pediatric Cardiac Surgery: Comparison Between a Balanced and a Non-balanced Colloid
This study will compare the clinical efficacy and safety of Volulyte® and Voluven® during elective open-heart surgery in pediatric patients.
- Trial name
- COLCHIRCARD (NCT02584868)
- Testing
- Hydroxyethyl starch 130/0.4 in an isotonic electrolyte solution, Hydroxyethyl starch 130/0.4 in 0.9% sodium chloride
- Where
- Belgium
- Volunteers
- 88 people
- Sponsor
- Queen Fabiola Children's University Hospital
Medulloblastoma, Childhood
177Lu-DTPA-Omburtamab Radioimmunotherapy for Recurrent or Refractory Medulloblastoma
Children and adolescents diagnosed with medullablastoma and with recurrent or refractory to frontline therapy will be treated with 177Lu-DTPA-omburtamab, which is a radioactive labelling of a murine monoclonal antibody targeting…
- Trial name
- NCT04167618
- Testing
- 177Lu-DTPA-omburtamab
- Where
- 10 sites in United States, Denmark and 3 more
- Volunteers
- 2 people
- Sponsor
- Y-mAbs Therapeutics
Hypertension, Chronic Kidney Disease
Safety and Tolerability of Valsartan in Children 6 to 17 Years of Age
The purpose of this study is to assess the long-term safety and tolerability profile of valsartan and valsartan-based treatments in children with hypertension, with or without chronic kidney disease.
- Trial name
- NCT01365481
- Testing
- Valsartan, amlodipine, Hydrochlorothiazide
- Where
- 28 sites in Colombia, Finland and 8 more
- Volunteers
- 150 people
- Sponsor
- Novartis Pharmaceuticals
Hematologic Diseases, Anemia, Sickle Cell
Hydroxyurea to Prevent Organ Damage in Children With Sickle Cell Anemia
The purpose of this study is to determine if hydroxyurea therapy is effective in the prevention of chronic end organ damage in pediatric patients with sickle cell anemia.
- Trial name
- NCT00006400
- Testing
- Hydroxyurea
- Where
- 14 sites in United States
- Volunteers
- 193 people
- Sponsor
- National Heart, Lung, and Blood Institute (NHLBI)
Ulcerative Colitis
Long-term Safety and Efficacy Study of Adalimumab in Pediatric Subjects With Ulcerative Colitis
This study assesses the long-term safety and efficacy of adalimumab in pediatric subjects with ulcerative colitis.
- Trial name
- NCT02632175
- Testing
- Adalimumab
- Where
- 16 sites in United States, Japan and 4 more
- Volunteers
- 59 people
- Sponsor
- AbbVie
Sepsis, Systemic Inflammatory Response Syndrome
PPV to Guide Fluid Management in the PICU
Children who are critically ill often require large amounts of fluid during their acute illness. It has been shown in multiple studies that appropriate administration of fluid decreases morbidity and mortality, but giving too…
- Trial name
- PPV (NCT02308371)
- Testing
- Automated Pulse Pressure Variation
- Where
- United States
- Volunteers
- 100 people
- Sponsor
- University of North Carolina, Chapel Hill
Neoplasms, Solid Tumors
A Study of Robatumumab (SCH 717454, MK-7454) in Combination With Different Treatment Regimens in Pediatric Participants With Advanced Solid Tumors (P05883, MK-7454-006)
This is a Phase 1/1B, non-randomized, open-label, dose-escalation study of robatumumab (SCH 717454, MK-7454) administered in combination with chemotherapy in pediatric participants with solid tumors, to be conducted in…
- Conditions
- Neoplasms, Solid Tumors, Bone Cancer, Kidney Tumor
- Trial name
- NCT00960063
- Testing
- Temozolomide, Vincristine, Ifosfamide
- Volunteers
- 4 people
- Sponsor
- Merck Sharp & Dohme LLC
Deep Vein Thrombosis
Incidence of Venous Thromboembolism in Children Undergoing Elective Neurosurgical Procedures
The purpose of this study is to determine how frequently children undergoing elective neurosurgical procedures develop blood clots in the deep veins of the legs while hospitalized.
- Trial name
- NCT02037607
- Where
- United States
- Volunteers
- 100 people
- Sponsor
- Indiana University
Epilepsy, Partial Seizures
An Open Label Study of Levetiracetam in Japanese Pediatric Patients With Partial Seizures
Objective of the First Period: To evaluate the efficacy of Levetiracetam dry syrup at doses up to a maximum of 60 mg/kg/day or 3000 mg/day used as an adjunctive therapy in Japanese pediatric patients (4 to 16 years) with…
- Trial name
- NCT01063764
- Testing
- Levetiracetam
- Where
- 29 sites in Japan
- Volunteers
- 73 people
- Sponsor
- UCB Japan Co. Ltd.
Asthma
Predictive Ability of Therapeutic Risk Factors in Pediatric and Adult Asthma Patients
The purpose of this study is to assess the predictive ability of three asthma risk markers: the ratio of controller medication to total asthma medication, an albuterol only marker, and an oral corticosteroid use marker, as well…
- Trial name
- NCT01346852
- Testing
- Asthma treatment with an asthma-related medication and at least one asthma controller medication
- Volunteers
- 101,437 people
- Sponsor
- GlaxoSmithKline
Anxiety Disorders
Threat Interpretation Bias as Cognitive Marker and Treatment Target in Pediatric Anxiety
Anxiety is the most common mental health problem in children and adolescents. This two-phased study will test the effects of an experimental computerized intervention aimed at reducing threat-based thinking (i.e., interpretation…
- Trial name
- NCT04245501
- Testing
- Cognitive Bias Modification for Interpretations (CBM-I), Interpretation Control Condition (ICC)
- Where
- United States
- Volunteers
- 50 people
- Sponsor
- University of Denver
Sanfilippo Syndrome, Mucopolysaccharidosis (MPS)
An Extension Study to Determine Safety and Efficacy for Pediatric Patients With MPS Type IIIA Disease Who Participated in Study HGT-SAN-093.
This extension study will allow participants to continue receiving treatment with HGT-1410 and to initiate treatment in patients who received no-treatment in Study HGT-SAN-093, and will evaluate the long-term safety and efficacy…
- Trial name
- NCT02350816
- Testing
- HGT-1410
- Where
- 8 sites in United States, France and 5 more
- Volunteers
- 17 people
- Sponsor
- Shire
Obesity, Pregnancy
Starting Pediatric Obesity Prevention in Pregnancy
The purpose of this study is to examine whether we can use social networks to spread health information and health behaviors during pregnancy to prevent excessive gestational weight gain.
- Trial name
- NCT01279109
- Testing
- Social network building intervention, Home visit
- Where
- United States
- Volunteers
- 147 people, healthy volunteers welcome
- Sponsor
- Wake Forest University Health Sciences
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