Clinical trials: Standard of Care
Venous Thromboembolism (VTE), Pulmonary Embolism
Hokusai Study in Pediatric Patients With Confirmed Venous Thromboembolism (VTE)
This is an event driven Phase 3, prospective, randomized, open-label, blinded endpoint evaluation (PROBE) parallel group study in subjects with confirmed VTE.
- Conditions
- Venous Thromboembolism (VTE), Pulmonary Embolism, Deep Vein Thrombosis (DVT)
- Trial name
- NCT02798471
- Testing
- Edoxaban, Standard of Care
- Where
- 140 sites in United States, Argentina and 32 more
- Volunteers
- 290 people
- Sponsor
- Daiichi Sankyo
Community Acquired Pneumonia
Bacterial Pneumonia Score (BPS) Guided Antibiotic Use in Children With Pneumonia and Pneumococcal Vaccine
The aim of this study is to test if BPS (Bacterial Pneumonia Score) guided antibiotic use in children with non severe community acquired pneumonia (CAP) and pneumoccocal vaccine will reduce antibiotic use as compared to standard…
- Trial name
- NCT01875731
- Testing
- BPS, Guideline
- Where
- Argentina
- Volunteers
- 66 people
- Sponsor
- Hospital General de Niños Pedro de Elizalde
Juvenile Idiopathic Arthritis
A Study of the Safety and Efficacy of CNTO 148 (Golimumab) in Children With Juvenile Idiopathic Arthritis (JIA) and Multiple Joint Involvement Who Have Poor Response to Methotrexate (GO KIDS)
The purpose of this study is to evaluate the efficacy and safety of golimumab (CNTO 148) in patients who have active juvenile idiopathic arthritis (JIA) and at least 5 joints with active arthritis that have poor response to…
- Trial name
- NCT01230827
- Testing
- CNTO 148 (Golimumab), Methotrexate
- Where
- 35 sites in United States, Austria and 10 more
- Volunteers
- 173 people
- Sponsor
- Janssen Research & Development, LLC
Neonatal Herpes Simplex Infection
Valacyclovir in Neonatal Herpes Simplex Virus Disease
This is an open-label, single center, pharmacokinetic (PK) study to assess valacyclovir pharmacokinetics and pharmacodynamics in neonates and compare to the pharmacokinetics and pharmacodynamics of the standard of care treatment…
- Trial name
- NCT04448392
- Testing
- Valacyclovir
- Where
- United States
- Volunteers
- 7 people
- Sponsor
- University of Alabama at Birmingham
Phenylketonurias
Open-label, Randomized, 2-way Crossover, Monocentric, Controlled Study to Evaluate the Effect on Daily PHE Fluctuation of PKU GOLIKE Versus SoC in Patients With PKU.
This is an open-label, randomized, 2-way crossover, monocentric controlled study in patients (≥ 16 years old) with phenylketonuria (PKU).
- Trial name
- NCT05827536
- Testing
- PKU GOLIKE, Standard of Care
- Where
- Italy
- Volunteers
- 21 people
- Sponsor
- APR Applied Pharma Research s.a.
Retinopathy of Prematurity (ROP)
Long-term Safety and Efficacy Outcome Study Comparing Children Previously Enrolled in Study ROPP-2008-01 for the Prevention of Retinopathy of Prematurity (ROP)
The main purpose of this study is to evaluate the long-term efficacy and safety outcomes following short-term exposure to rhIGF-1/rhIGFBP-3 versus standard neonatal care in Study ROPP-2008-01 (NCT01096784).
- Trial name
- PEDAL (NCT02386839)
- Testing
- rhIGF-1/rhIGFBP-3
- Where
- 16 sites in United States, Italy and 4 more
- Volunteers
- 76 people
- Sponsor
- Shire
Dravet Syndrome
A 2-Part Study to Investigate the Dose-Ranging Safety and Pharmacokinetics, Followed by the Efficacy and Safety of ZX008 (Fenfluramine Hydrochloride) Oral Solution as an Adjunctive Therapy in Children ≥ 2 Years Old and Young Adults With Dravet Syndrome
The primary purpose of this study is to evaluate the safety, tolerability, and efficacy of ZX008 (fenfluramine hydrochloride) when added to adjunctive antiepileptic stiripentol treatment in children and young adults with Dravet…
- Trial name
- NCT02926898
- Testing
- ZX008 (Fenfluramine Hydrochloride)
- Where
- 28 sites in United States, Canada and 5 more
- Volunteers
- 87 people
- Sponsor
- Zogenix International Limited, Inc., a subsidiary of Zogenix, Inc.
Polycystic Ovarian Syndrome, Obesity
Post-Prandial Liver Glucose Metabolism in PCOS
The Investigators will measure if hepatic metabolism is upregulated in obese girls with PCOS and hepatic steatosis (HS), compared to PCOS without HS and obese controls without HS.
- Conditions
- Polycystic Ovarian Syndrome, Obesity, Hepatic Steatosis
- Trial name
- PLUM (NCT03041129)
- Testing
- oral glucose tolerance test, MRI of liver
- Where
- United States
- Volunteers
- 19 people, healthy volunteers welcome
- Sponsor
- University of Colorado, Denver
Systemic Lupus Erythematosus
A Study of Belimumab in Chinese Pediatric Participants With Systemic Lupus Erythematosus
This study will evaluate the pharmacokinetic characteristics and safety of belimumab subcutaneous (SC) in Chinese pediatric participants with SLE who have completed 48 weeks belimumab Intravenous (IV) treatment in 213560 study…
- Trial name
- NCT05917288
- Testing
- Belimumab, Standard of care
- Where
- 6 sites in China
- Volunteers
- 16 people
- Sponsor
- GlaxoSmithKline
Asthma
Efficacy and Safety Study of QAW039 in Patients With Severe Asthma Inadequately Controlled With Standard of Care Asthma Treatment.
This study aimed to determine the efficacy and safety of QAW039 150 mg and QAW039 450 mg, compared with placebo, when added to GINA (Global Initiative for Asthma) steps 4 and 5 standard-of- care (SoC) asthma therapy (GINA 2016)…
- Trial name
- NCT02555683
- Testing
- QAW039
- Where
- 234 sites in United States, Argentina and 25 more
- Volunteers
- 894 people
- Sponsor
- Novartis Pharmaceuticals
Acute Heart Failure
Pharmacokinetics & Safety of Serelaxin on Top of Standard of Care Therapy in Pediatric Patients With Acute Heart Failure
The purpose of the study was to evaluate the safety, tolerability and pharmacokinetics of an intravenous infusion of serelaxin on top of standard of care therapy, in pediatric patients with acute heart failure (AHF)
- Trial name
- RELAX-PEDS-PK (NCT02151383)
- Testing
- Serelaxin
- Where
- 10 sites in United States, Germany and 2 more
- Volunteers
- 12 people
- Sponsor
- Novartis Pharmaceuticals
Neoplasm Metastasis
Stem Cell Transplantation for Metastatic Solid Tumors
The goal of this research study is to identify other types of cancer (malignant neoplasms) that may be treatable with stem cell transplantation (allogenic peripheral blood stem cell transplantation.
- Trial name
- NCT00001880
- Testing
- methotrexate, Cyclosporin
- Where
- United States
- Volunteers
- 42 people
- Sponsor
- National Heart, Lung, and Blood Institute (NHLBI)
Venous Thromboembolism
EINSTEIN Junior: Oral Rivaroxaban in Children With Venous Thrombosis
The purpose of this study is to evaluate comparative efficacy and safety of rivaroxaban to standard of care in children with acute venous thromboembolism.
- Trial name
- EINSTEIN Jr (NCT02234843)
- Testing
- Rivaroxaban (Xarelto, BAY59-7939), Standard of Care
- Where
- 109 sites in United States, Argentina and 26 more
- Volunteers
- 500 people
- Sponsor
- Bayer
Asthma
Study of Efficacy and Safety of QAW039 in Patients With Severe Asthma Inadequately Controlled With Standard of Care Asthma Treatment.
This study aimed to determine the efficacy and safety of QAW039 and QAW039 450 mg compared to placebo, when added to GINA (Global Initiative for Asthma) steps 4 and 5 standard-of- care (SoC) asthma therapy (GINA 2016) in the…
- Trial name
- NCT02563067
- Testing
- QAW039
- Where
- 163 sites in United States, Argentina and 17 more
- Volunteers
- 877 people
- Sponsor
- Novartis Pharmaceuticals
Acute Myeloid Leukemia (AML), Cancer
A Study Evaluating Safety and Efficacy of Venetoclax in Combination With Azacitidine Versus Standard of Care After Allogeneic Stem Cell Transplantation (SCT) in Participants With Acute Myeloid Leukemia (AML)
The main objective of this study is to evaluate the efficacy of venetoclax in combination with azacitidine to improve Overall Survival (OS) in Acute Myeloid Leukemia (AML) participants compared to Best Supportive Care (BSC) when…
- Trial name
- VIALE-T (NCT04161885)
- Testing
- Venetoclax, Azacitidine, Best Supportive Care (BSC)
- Where
- 165 sites in United States, Australia and 16 more
- Volunteers
- 465 people
- Sponsor
- AbbVie
Staphylococcus Aureus Bacteremia, Staphylococcus Aureus Endocarditis
Direct Lysis of Staph Aureus Resistant Pathogen Trial of Exebacase
The purpose of this superiority study is to evaluate the efficacy and safety of exebacase in addition to standard of care antibiotics (SoCA) compared with SoCA alone for the treatment of patients with Staphylococcus aureus (S.
- Trial name
- DISRUPT (NCT04160468)
- Testing
- Exebacase
- Where
- 55 sites in United States
- Volunteers
- 259 people
- Sponsor
- ContraFect
Neoplasms
A Study of Encorafenib Plus Cetuximab With or Without Chemotherapy in People With Previously Untreated Metastatic Colorectal Cancer
The purpose of this study is to evaluate two study medicines (encorafenib plus cetuximab) taken alone or together with standard chemotherapy for the potential treatment of colorectal cancer that: has spread to other parts of the…
- Trial name
- NCT04607421
- Testing
- Encorafenib, Cetuximab, Oxaliplatin
- Where
- 274 sites in United States, Argentina and 27 more
- Volunteers
- 841 people
- Sponsor
- Pfizer
Lung Diseases, Interstitial
A Study to Find Out How Nintedanib is Taken up in the Body and How Well it is Tolerated in Children and Adolescents With Interstitial Lung Disease (ILD)
The main objective of the study is to evaluate dose-exposure and safety of nintedanib in children and adolescents with fibrosing Interstitial Lung Disease (ILD).
- Trial name
- InPedILD® (NCT04093024)
- Testing
- Nintedanib
- Where
- 43 sites in United States, Argentina and 19 more
- Volunteers
- 39 people
- Sponsor
- Boehringer Ingelheim
Bronchiolitis
Nebulized 3% Hypertonic Saline vs. Standard of Care in Patients With Bronchiolitis
The purpose of this study is to determine whether nebulized 3% hypertonic saline is more effective than the current standard of care in the treatment of viral bronchiolitis in children.
- Trial name
- NCT02834819
- Testing
- 3% Nebulized Hypertonic Saline
- Volunteers
- 18 people
- Sponsor
- University of Colorado, Denver
Visual Pathway Glioma
Antineoplaston Therapy in Treating Children With Visual Pathway Glioma
RATIONALE: Current therapies for children with visual pathway gliomas, which are not amenable to or have not responded to standard therapy, provide limited benefit to the patient.
- Trial name
- VPG (NCT00003477)
- Testing
- Antineoplaston therapy (Atengenal + Astugenal)
- Where
- United States
- Volunteers
- 12 people
- Sponsor
- Burzynski Research Institute