Clinical trials: Care Delivery
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
Low-Birth-Weight Infant, Premature Infants
Analyzer of Human Milk: Applicability in Clinical Practice in Order to Achieve the Best Nutrition for Infants
An observational and prospective study involving about 30 healthy lactating mothers whose preterm infant(s) is/are hospitalized at Neonatal Intensive Care Unit after childbirth and who can provide enough maternal milk (3mL) to be…
- Trial name
- MISTU (NCT02971904)
- Testing
- human milk collection
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Danone Early Life Nutrition Brazil
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
Preterm Birth, Low; Birthweight, Extremely (999 Grams or Less)
Clinical Evaluation of the "NICU Clinical Decision Support Dashboard" - MHSB
This study evaluates the use of a NICU clinical integration system (Dashboard and accessories) in improving the quality of care delivered, patient health outcomes, and parent and clinician satisfaction.
- Conditions
- Preterm Birth, Low; Birthweight, Extremely (999 Grams or Less), Neonatal Infection, Satisfaction
- Trial name
- NCT03673579
- Testing
- NICU Dashboard
- Where
- United States
- Sponsor
- Philips Healthcare
Preterm Birth, Low; Birthweight, Extremely (999 Grams or Less)
Clinical Evaluation of the "NICU Clinical Decision Support Dashboard" - CHMCO
This study evaluates the use of a NICU clinical integration system (Dashboard and accessories) in improving the quality of care delivered, patient health outcomes, and parent and clinician satisfaction.
- Conditions
- Preterm Birth, Low; Birthweight, Extremely (999 Grams or Less), Neonatal Infection, Satisfaction
- Trial name
- NCT03673566
- Testing
- NICU Dashboard
- Where
- United States
- Sponsor
- Philips Healthcare
Left Ventricular Systolic Dysfunction, Heart Failure (Pediatric)
A Study to Learn More About How Safe Finerenone is, When it is Taken for a Longer Time With Standard Treatment, in Children and Young Adults With Heart Failure and Left Ventricular Systolic Dysfunction
Researchers are looking for a better way to treat children and young adults who have heart failure with left ventricular systolic dysfunction (LVSD).
- Trial name
- FIORELLO (NCT07192952)
- Testing
- Finerenone (Kerendia, BAY94-8862)
- Where
- 132 sites in United States, Argentina and 21 more
- Volunteers
- 117 people
- Sponsor
- Bayer
Cancer
PERTH 2: Co-design of a Home-based Monitoring Service for Cancer Patients to Optimize Delivery of Systemic Therapy.
Iterative co-design study where patients receiving systemic cancer therapy, carers and healthcare professionals involved in delivering cancer therapy, work with Entia to design a home based blood monitoring service.
- Trial name
- NCT03923296
- Testing
- Blood measurement and monitoring, Interviews
- Where
- United Kingdom
- Volunteers
- 62 people
- Sponsor
- Entia Ltd
Asthma
Efficacy and Safety of 2 Doses of Tiotropium Respimat Compared to Placebo in Adolescents With Severe Persistent Asthma
The overall purpose of the trial is to evaluate efficacy and safety of tiotropium inhalation solution delivered via Respimat® inhaler (2.5 mcg and 5 mcg once daily) over 12 weeks, compared to placebo, as add-on controller therapy…
- Trial name
- NCT01277523
- Testing
- tiotropium high dose, tiotropium low dose
- Where
- 69 sites in United States, Argentina and 12 more
- Volunteers
- 392 people
- Sponsor
- Boehringer Ingelheim
Acute Respiratory Distress Syndrome
KL₄Surfactant Treatment in Patients With ARDS
Lung wash with KL₄Surfactant of individual lung segments using a bronchoscope compared to usual care alone consisting primarily of assisted (mechanical) ventilation in patients with acute respiratory distress syndrome(ARDS).
- Trial name
- NCT00215553
- Testing
- A.1 Lucinactant, B.3 SoC, A.2 Lucinactant
- Where
- United States
- Volunteers
- 124 people
- Sponsor
- Windtree Therapeutics
Locally Resectable Pediatrics Tumors
CEB-01 in Pediatrics With Locally Resectable Abdominal Tumors
The CEB-01 implant is a membrane containing SN-38, the active metabolite of irinotecan, an already authorized chemotherapeutic agent.
- Trial name
- NCT06986811
- Testing
- Standard surgery, CEB-01
- Where
- Spain
- Volunteers
- 80 people
- Sponsor
- CEBIOTEX
Catheters, Indwelling, Preterm Birth
Evaluation of Intravascular Monitoring of Partial PRessure of Oxygen for Neonatal IntensiVE Care Patients -3
The study is a non-blinded trial with one single intervention in sick newborn infants. The Neosense umbilical catheter will be used instead of the routinely used umbilical catheter on infants where the treating physician has…
- Conditions
- Catheters, Indwelling, Preterm Birth, Compromised Health
- Trial name
- IMPROVE (NCT06616012)
- Testing
- Neosense umbilical catheter
- Where
- 6 sites in Sweden
- Volunteers
- 50 people
- Sponsor
- Neosense Technologies
Cystic Fibrosis
A 4-week Study to Test Different Doses of BI 1265162 in Adolescents and Adults With Cystic Fibrosis Using the Respimat® Inhaler - BALANCE - CF™1
The primary objective of this trial is to assess the efficacy, safety and pharmacokinetics of twice daily inhaled doses of BI 1265162 delivered by Respimat® inhaler versus placebo in adolescents and adult patients with cystic…
- Trial name
- NCT04059094
- Testing
- BI 1265162
- Where
- 26 sites in United States, Belgium and 6 more
- Volunteers
- 52 people
- Sponsor
- Boehringer Ingelheim
Respiratory Distress Syndrome In Premature Infants
Safety and Efficacy Study of the Draeger Babylog VN500 Device in HFOV Mode in VLBW Neonates
The purpose of this study is to determine the safety and effectiveness of the Babylog VN500 in high frequency oscillatory ventilation (HFOV) mode as a method for treating very low birth weight (VLBW) neonates requiring invasive…
- Trial name
- NCT02445040
- Testing
- Babylog VN500 in HFOV Mode
- Where
- 14 sites in United States
- Volunteers
- 225 people
- Sponsor
- Draeger Medical Systems, Inc.
Catheter-Related Infections
Open-Label Study to Assess Safety and Time to Catheter-related Bloodstream Infections (CRBSI) in Subjects From Birth to < 18 Years of Age
This study is a post-marketing approval requirement to assess the safety and time to Catheter-related Bloodstream Infections (CRBSI) of DefenCath in pediatric population (birth to less than 18 years of age) who are on chronic HD…
- Trial name
- NCT06714864
- Testing
- (taurolidine and heparin) catheter lock solution, Standard of Care
- Where
- 6 sites in United States
- Volunteers
- 36 people
- Sponsor
- CorMedix Therapeutics
Venous Thromboembolism
Open Label Study Comparing Efficacy and Safety of Dabigatran Etexilate to Standard of Care in Paediatric Patients With Venous Thromboembolism (VTE)
The main objectives of this large phase IIb/III paediatric study are to assess the efficacy and safety of dabigatran etexilate relative to standard of care and to document the appropriateness of the proposed dabigatran etexilate…
- Trial name
- NCT01895777
- Testing
- dabigatran etexilate, standard of care
- Where
- 65 sites in United States, Argentina and 24 more
- Volunteers
- 267 people
- Sponsor
- Boehringer Ingelheim
Premature Infants
Compliance to Synagis (Palivizumab) Under Daily Pediatrician´s Conditions in Premature Infants 33 - 35 wGA
Compliance to Synagis (palivizumab) is a key factor to obtain maximal protection against respiratory syncytial virus (RSV) infection as shown in the IMpact study.
- Trial name
- NCT01077271
- Where
- 45 sites in Austria
- Volunteers
- 124 people
- Sponsor
- Abbott
Asthma
Efficacy and Safety of 2 Doses of Tiotropium Respimat® Compared to Placebo in Children With Severe Persistent Asthma
The overall purpose of the trial is to evaluate efficacy and safety of tiotropium inhalation solution (2.5 mcg and 5 mcg) delivered via Respimat® inhaler once daily in the evening over 12 weeks, compared to placebo, as add-on…
- Trial name
- NCT01634152
- Testing
- Tiotropium low dose mcg, Tiotropium high dose
- Where
- 94 sites in United States, Argentina and 15 more
- Volunteers
- 401 people
- Sponsor
- Boehringer Ingelheim
Duchenne Muscular Dystrophy
An Observational Study Comparing Delandistrogene Moxeparvovec (ELEVIDYS) With Standard of Care in Participants With Duchenne Muscular Dystrophy
This is a multicenter, prospective, observational Phase 4 study including a post marketing safety requirement, designed to collect both medical history data and prospective data on Duchenne muscular dystrophy (DMD) treatment…
- Trial name
- ENDURE (NCT06270719)
- Testing
- Delandistrogene Moxeparvovec, Standard of Care
- Where
- 29 sites in United States
- Volunteers
- 500 people
- Sponsor
- Sarepta Therapeutics, Inc.
Respiratory Distress Syndrome
Comparison of Aerosol Delivery of Infasurf to Usual Care in Spontaneously Breathing RDS Patients
Study to test the hypothesis that aerosolized Infasurf can decrease the need for intubation and instillation of liquid surfactant to the airway.
- Trial name
- NCT03058666
- Testing
- Aerosolized Calfactant, Solarys
- Where
- 22 sites in United States
- Volunteers
- 477 people
- Sponsor
- ONY