Clinical trials: Pediatric Safety and Effectiveness
Crohn's Disease, Complex Perianal Fistula
A Study of Darvadstrocel for Treating Complex Perianal Fistulas in Children and Teenagers With Crohn's Disease
A perianal fistula is an abnormal passageway that develops between the rectum and the skin near the anus. The fistula is considered complex if it branches into several openings or an abscess is also present.
- Trial name
- NCT04701411
- Testing
- Darvadstrocel
- Where
- 22 sites in Israel, Japan and 3 more
- Volunteers
- 7 people
- Sponsor
- Takeda
Bacteremia, Soft Tissue Infections
Safety, Efficacy, and Pharmacokinetics (PK) of Daptomycin (MK-3009) in Japanese Pediatric Subjects With Complicated Skin and Soft Tissue Infections (cSSTI) and Bacteremia (MK-3009-029)
The purpose of this study is to assess the safety, efficacy and pharmacokinetic (PK) parameters of daptomycin for injection in Japanese pediatric participants aged 1 to 17 years with complicated skin and soft tissue infection…
- Conditions
- Bacteremia, Soft Tissue Infections, Skin Diseases, Infectious
- Trial name
- NCT03643952
- Testing
- Daptomycin for Injection
- Where
- 16 sites in Japan
- Volunteers
- 18 people
- Sponsor
- Merck Sharp & Dohme LLC
Pediatric Cancers, Solid Tumor Pediatric
Safety and Efficacy of CMD03 CAR T Cell in Children With Relapse or Refractory Solid Tumors
A Phase 1 clinical trial to evaluate the safety and early efficacy of CAR T-cells with IL-7Ra signal targeting B7H3 in children with solid tumors patients after complete standard treatments.
- Trial name
- CMD03 (NCT06612645)
- Testing
- B7H3-IL7Ra CAR-T cells
- Where
- Thailand
- Volunteers
- 9 people
- Sponsor
- Chulalongkorn University
Myopia
Pivotal Study of SAT-001 in Treatment of Pediatric Patient With Myopia
The objective of this clinical investigation is to evaluate the efficacy and safety of SAT-001 designed as Software as Medical Device (SaMD) for slowing myopia progression and treatment in pediatric myopia patients.
- Trial name
- NCT06344572
- Testing
- SAT-001, Single vision spectacles
- Where
- South Korea
- Volunteers
- 110 people
- Sponsor
- S-Alpha Therapeutics, Inc.
Sickle Cell Disease, Acute Chest Syndrome
Efficacy and Safety of Tocilizumab for Acute Chest Syndrome Treatment in Patients With Sickle Cell Disease
The purpose of this study is to determine whether a single infusion of tocilizumab is effective in reducing the time to successful weaning from both supplemental oxygen and any respiratory support, in pediatric and adult patients…
- Trial name
- TOCIACS (NCT06818266)
- Testing
- Tocilizumab (RoActemra®, 20 mg/mL).
- Where
- France
- Volunteers
- 130 people
- Sponsor
- Assistance Publique - Hôpitaux de Paris
Cardiac Defect
Safety and Efficacy of Acute Normovolemic Hemodilution in Pediatric Cardiac Surgery Patients
The investigators primary objective is to determine if acute normovolemic hemodilution (ANH) for pediatric cardiac surgical patients decreases the volume of blood products transfused during surgery and the immediate…
- Trial name
- NCT02751645
- Testing
- Acute Normovolemic hemodilution
- Where
- United States
- Volunteers
- 24 people
- Sponsor
- Oregon Health and Science University
Pediatric Chronic Inflammatory Demyelinating Polyneuropathy
Study to Evaluate Safety and Efficacy of Different PANZYGA Dose Regimens in Pediatric Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP) Patients
Safety and Efficacy of Different PANZYGA Dose Regimens in Pediatric Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP) Patients
- Trial name
- NCT04929236
- Testing
- Panzyga
- Where
- 6 sites in United States
- Volunteers
- 30 people
- Sponsor
- Octapharma
Rhinitis, Allergic, Seasonal, Rhinitis, Allergic, Perennial
Observation of Side Effects and Effectiveness of Desloratadine (Aerius) Syrup in Filipino Children (Study P05634)
The purpose of this study is to observe the side effects of desloratadine syrup and how effective it is in relieving symptoms of allergic rhinitis or hives in Filipino children.
- Conditions
- Rhinitis, Allergic, Seasonal, Rhinitis, Allergic, Perennial, Urticaria
- Trial name
- NCT00761527
- Testing
- Desloratadine Syrup
- Volunteers
- 2,980 people
- Sponsor
- Organon and Co
Generalized Myasthenia Gravis, gMG
PK, PD, Safety, and Efficacy Study of Gefurulimab in Pediatric Patients With AChR+ Generalized Myasthenia Gravis
The primary objective of this study is to assess the pharmacokinetics and pharmacodynamics of gefurulimab in pediatric participants with AChR+ gMG for the duration of the study.
- Trial name
- NCT06607627
- Testing
- Gefurulimab
- Where
- 13 sites in United States, Brazil and 3 more
- Volunteers
- 12 people
- Sponsor
- Alexion Pharmaceuticals, Inc.
Myopia, Progressive
Efficacy of IVMED-85 on Pediatric Myopia
The goal of this clinical trial is to evaluate the safety and preliminary efficacy of a 1-year course of IVMED-85 eye drops for the treatment of pediatric myopia by assessing its safety effects on visual acuity and its effect on…
- Trial name
- NCT05761795
- Testing
- IVMED 85
- Volunteers
- 216 people
- Sponsor
- iVeena Delivery Systems, Inc.
Ulcerative Colitis
A Study of the Safety and Efficacy of Infliximab(REMICADE ) in Pediatric Patients With Moderately to SeverelyActive Ulcerative Colitis
The purpose of the study is to evaluate the effectiveness and safety of infliximab (Remicade) in children with moderately to severely active ulcerative colitis.
- Trial name
- NCT00336492
- Testing
- infliximab
- Where
- 27 sites in United States, Belgium and 3 more
- Volunteers
- 60 people
- Sponsor
- Centocor, Inc.
Migraine
Efficacy and Safety of Erenumab in Pediatric Subjects With Chronic Migraine
This study will evaluate the efficacy and safety of erenumab in migraine prevention in children (6 to <12 years) and adolescents (12 to <18 years) with chronic migraine.
- Trial name
- OASIS(CM) (NCT03832998)
- Testing
- Erenumab Dose 1, Erenumab Dose 2, Erenumab Dose 3
- Where
- 101 sites in United States, Belgium and 11 more
- Volunteers
- 284 people
- Sponsor
- Amgen
Melanoma
A Study to Evaluate Treatment With Nivolumab Alone and Nivolumab Combined With Ipilimumab in Children With Melanoma
The purpose of this study is to describe real-world safety outcomes in children with melanoma who are treated with nivolumab alone or nivolumab in combination with ipilimumab for unresectable or metastatic melanoma, or treated…
- Trial name
- NCT06163170
- Testing
- Nivolumab +/- ipilimumab, Nivolumab
- Where
- United States
- Volunteers
- 100 people
- Sponsor
- Bristol-Myers Squibb
Pediatric, Symptomatic Obstructive Hypertrophic Cardiomyopathy
A Study to Evaluate the Effect of Aficamten in Pediatric Patients With Symptomatic Obstructive Hypertrophic Cardiomyopathy (oHCM).
The purpose of this study is to evaluate the efficacy, safety and pharmacokinetics of aficamten in a pediatric population with symptomatic obstructive hypertrophic cardiomyopathy (oHCM).
- Trial name
- CEDAR-HCM (NCT06412666)
- Testing
- Aficamten
- Where
- 36 sites in United States, Canada and 4 more
- Volunteers
- 65 people
- Sponsor
- Cytokinetics
Central Nervous System Diseases, Central Nervous System Neoplasms
Evaluation of Safety and Efficacy of ProHance in Pediatric Patients <2yrs
Safety and Efficacy Study in pediatric subjects <2 years of age who have undergone Brain or Spine MRI pre and post 0.1 mmol/kg ProHance administration. Imaging conditions will represent those in routine clinical practice.
- Trial name
- NCT03750188
- Testing
- ProHance
- Where
- United States
- Volunteers
- 125 people
- Sponsor
- Bracco Diagnostics, Inc
Atypical Hemolytic Uremic
Eculizumab in Pediatric and Adult Participants With Atypical Hemolytic Uremic Syndrome (aHUS) in China
This is a Phase 3b, open-label, single-arm, multicenter study to evaluate the efficacy and safety of eculizumab in participants with atypical hemolytic uremic syndrome (aHUS) in China
- Trial name
- Soliris (NCT05876351)
- Testing
- Eculizumab
- Where
- 6 sites in China
- Volunteers
- 25 people
- Sponsor
- Alexion Pharmaceuticals, Inc.
Psoriasis
A Study of Subcutaneous Risankizumab Injection for Pediatric Participants With Moderate to Severe Plaque Psoriasis to Assess Change in Disease Symptoms
Psoriasis is a chronic, systemic, inflammatory disease in which skin cells build up and develop thick, red and white scaly patches on the skin.
- Trial name
- OptIMMize-1 (NCT04435600)
- Testing
- Risankizumab, Ustekinumab
- Where
- 53 sites in United States, Canada and 5 more
- Volunteers
- 139 people
- Sponsor
- AbbVie
Increasing the First Aid Knowledge and Practice Levels of Parents, Accidental Injuries
Evaluation of the Effectiveness of the First Aid Program Applied to Parents of 0-6 Year Old Children
Purpose: Accidents/injuries seen in children aged 0-6 in developed and developing countries are among the leading preventable health problems and are among the leading causes of death and disability.
- Conditions
- Increasing the First Aid Knowledge and Practice Levels of Parents, Accidental Injuries, Pediatric Emergency Care, First Aid Training
- Trial name
- NCT07066007
- Testing
- First Aid Education Programme
- Where
- Turkey (Türkiye)
- Volunteers
- 74 people, healthy volunteers welcome
- Sponsor
- Semra SÖNGÜT
Bipolar I Disorder
The Young Adult and Pediatric Bipolar Study
To examine the safety and effectiveness of extended-release carbamazepine in the treatment of children and adolescents aged 10-17 years with acute manic or mixed bipolar I disorder.
- Trial name
- NCT00350857
- Testing
- Extended-Release Carbamazepine
- Where
- 26 sites in United States
- Volunteers
- 161 people
- Sponsor
- Validus Pharmaceuticals
Anesthesia
A Study to Evaluate the Safety and Efficacy of Ultiva (Remifentanil Hydrochloride) in Pediatric Participants General Anesthetised
The purpose of this study is to evaluate the efficacy and safety of JNJ-268229 (Ultiva /Remifentanil Hydrochloride) in pediatric participants between 1 and 15 years of age during maintenance of general anesthesia.
- Trial name
- NCT01998165
- Testing
- Remifentanil
- Where
- 9 sites in Japan
- Volunteers
- 80 people
- Sponsor
- Janssen Pharmaceutical K.K.
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