Clinical trials: Craniosynostoses
Acute Respiratory Distress Syndrome ARDS
Driving Pressure-guided Tidal Volume Ventilation in the Acute Respiratory Distress Syndrome
Acute respiratory distress syndrome (ARDS) is associated with high mortality, some of which can be attributed to ventilator-induced lung injury (VILI) when artificial ventilation is not customized to the severity of lung injury.
- Trial name
- DRIVENT (NCT06322758)
- Testing
- Tidal volume customization in the acute respiratory distress syndrome
- Volunteers
- 750 people
- Sponsor
- Assistance Publique - Hôpitaux de Paris
Craniosynostosis, Sagittal, Scaphocephaly
Examination of Neuromotor Development of Cases Diagnosed with Scaphocephaly
It's an observational study. Purpose of the study: To evaluate the neuromotor development of scaphocephaly cases. 21 infants diagnosed with scaphocephaly aged 2-17 months were included.
- Conditions
- Craniosynostosis, Sagittal, Scaphocephaly, Developmental Delay
- Trial name
- NCT06294626
- Testing
- Group 1
- Where
- Turkey (Türkiye)
- Volunteers
- 21 people
- Sponsor
- Acıbadem Atunizade Hospital
Cholangiocarcinoma
Efficacy and Safety of Pemigatinib in Subjects With Advanced/Metastatic or Surgically Unresectable Cholangiocarcinoma Who Failed Previous Therapy - (FIGHT-202)
The purpose of this study is evaluate the efficacy of pemigatinib in subjects with advanced/metastatic or surgically unresectable cholangiocarcinoma with FGFR2 translocation who have failed at least 1 previous treatment.
- Trial name
- NCT02924376
- Testing
- Pemigatinib
- Where
- 120 sites in United States, Belgium and 10 more
- Volunteers
- 147 people
- Sponsor
- Incyte Corporation
Advanced Cancer
Lucitanib (E3810) in Patients With Advanced Cancer and FGFR, VEGFR, or PDGFR Pathway Aberrations
Lucitanib is an oral multi kinase inhibitor designed to block the action of certain molecules called "angiogenic factors" that may cause tumors to grow.
- Trial name
- NCT02747797
- Testing
- Lucitanib
- Where
- United States
- Sponsor
- Teresa Helsten, MD
Plagiocephaly, Nonsynostotic, Brachycephaly
Effects of Corrective Helmet Therapy on Cervical Motion and Thermoregulation in Children With Positional Deformities
The purpose of the study is to examine how cranial helmet therapy may affect neck movement and body temperature regulation in children with positional head deformity.
- Trial name
- NCT07201324
- Testing
- cranial helmet therapy - observational
- Volunteers
- 270 people
- Sponsor
- Wroclaw University of Health and Sport Sciences
Cholangiocarcinoma
A Study of E7090 in Participants With Unresectable Advanced or Metastatic Cholangiocarcinoma With Fibroblast Growth Factor Receptor (FGFR) 2 Gene Fusion
The primary purpose of the study is to assess the objective response rate (ORR) of E7090 by Response Evaluation Criteria In Solid Tumors (RECIST) 1.1 based on independent imaging review (IIR) in participants with unresectable…
- Trial name
- NCT04238715
- Testing
- E7090
- Where
- 56 sites in China, Japan
- Volunteers
- 63 people
- Sponsor
- Eisai Co., Ltd.
Craniosynostoses
EPBONF : Evaluation of the Safety and Effectiveness of a Medical Device Aimed at Guiding Orbito-naso-frontal Band Surgery, for the Treatment of Craniostenoses
Craniostenosis is a congenital disorder caused by early fusion of the cranial sutures between the skull bones, resulting in orbito-naso-frontal deformities.
- Trial name
- EPBONF (NCT06366178)
- Testing
- BONFIX system
- Volunteers
- 5 people
- Sponsor
- Centre Hospitalier Universitaire de Besancon
Craniosynostosis
Efficacy of Amicar for Children Having Craniofacial Surgery
The purpose of this study is to determine whether Amicar (ε-aminocaproic acid) is effective in reducing blood loss in children undergoing craniofacial reconstruction surgery.
- Trial name
- NCT02229968
- Testing
- Amicar (ε-aminocaproic acid), normal saline
- Where
- United States
- Volunteers
- 22 people
- Sponsor
- Children's National Research Institute
Plagiocephaly, Craniosynostosis
Hanger Helmet Study
The purpose of this study is to examine a group of patients requiring helmet therapy (either patients with plagiocephaly or post-surgical patients) to compare outcomes of infants treated with the Hanger helmet (Hanger, Inc.) to…
- Trial name
- NCT02561728
- Testing
- Hangar Helmet, P-Pod Helmet
- Sponsor
- Children's Hospital Medical Center, Cincinnati
Metopic Craniosynostosis
Comparison of a Bone Product to Bone Dust in Ossification of Small Calvarial Defects.
In this study we want to compare the effectiveness of a bone substitute (Allogenix Plus, a product derived from a dead human being that has chosen to donate it prior to dying) and bone dust from the patient's own bone pieces…
- Trial name
- DBM (NCT01006148)
- Testing
- Allogenix Plus
- Where
- United States
- Sponsor
- University of Missouri-Columbia
Non Synostotic Plagiocephaly
Effect of Usage Time of Helmet in Babies With Deformational Plagiocephaly
Investigating the optimal usage time of helmet therapy is the aim of the study. Participants will be babies with deformational plagiocephaly. Plagiocephalometric assesments will be utilize to follow improvement of head symmetry.
- Trial name
- NCT03430739
- Testing
- No intervention
- Where
- Turkey (Türkiye)
- Volunteers
- 28 people
- Sponsor
- Hacettepe University
Craniosynostosis
Comparison of the Rate of Preoperative Haemoglobin After Administration of Epoetin Alpha Associated With an Oral Medical Supplementation Versus Intravenous Before Surgery of Craniosynostosis at the Child
Oral iron is commonly used in conjunction with EPO preoperatively for hemorrhagic surgeries in children and especially in the surgery of craniosynostosis.
- Trial name
- IRON KID (NCT03231085)
- Testing
- Ferrous fumarate or ferrostrane
- Where
- 2 sites in France
- Volunteers
- 100 people
- Sponsor
- University Hospital, Montpellier
Premature Newborns, Cranial Asymmetry
Effects of Tummy Time Associated With Therapeutic Positioning in Premature Newborns With Cranial Asymmetry
Deformational plagiocephaly is an alteration in the shape of a baby's head caused by pressure exerted on the skull. This condition can begin during gestation and worsen after birth, especially when the baby spends a lot of time…
- Trial name
- plagiocephaly (NCT07758426)
- Testing
- Tummy Time Protocol
- Where
- Brazil
- Volunteers
- 300 people, healthy volunteers welcome
- Sponsor
- Hospital de Clinicas de Porto Alegre
Metopic Craniosynostosis, Craniosynostosis
Frontal Reconstruction Without Orbital Advancement for Moderate Metopic Craniosynostosis
Metopic craniosynostosis is a condition caused by the early fusion of the metopic suture, leading to restricted frontal bone growth and a triangular head deformity termed trigonocephaly.
- Conditions
- Metopic Craniosynostosis, Craniosynostosis, Metopic Synostosis
- Trial name
- NCT07837453
- Testing
- Frontal vault remodelling without orbital advancement
- Where
- Egypt
- Volunteers
- 15 people
- Sponsor
- Assiut University
Craniosynostosis
Endoscopic Treatment for Isolated, Single Suture Craniosynostosis
This is a prospective study to evaluate outcomes in patients undergoing endoscopic craniectomy for isolated, single-suture craniosynostosis.
- Trial name
- NCT00769847
- Testing
- Endoscopic strip craniectomy
- Volunteers
- healthy volunteers welcome
- Sponsor
- University of Utah
Urinary Bladder Neoplasms, Receptors, Fibroblast Growth Factor
A Study of Erdafitinib Intravesical Delivery System in Japanese Participants With Bladder Cancer
The purpose of the study is to determine the tolerability of erdafitinib intravesical delivery system (TAR-210) in Japanese participants.
- Trial name
- TAR-210 (NCT05567185)
- Testing
- Erdafitinib Intravesical Delivery System
- Where
- 4 sites in Japan
- Volunteers
- 5 people
- Sponsor
- Janssen Pharmaceutical K.K.
Craniosynostosis
The Efficacy and Population Pharmacokinetics of Tranexamic Acid for Craniosynostosis Surgery
This research study is being performed to evaluate two different doses of Tranexamic acid (TXA) in children who have craniosynostosis and have been referred to Boston Children's Hospital for corrective surgery.
- Trial name
- NCT02188576
- Testing
- high dose TXA, Low dose TXA
- Where
- United States
- Volunteers
- 66 people
- Sponsor
- Boston Children's Hospital
Craniosynostosis, Sagittal
Endoscopic Strip Craniectomy for Treatment of Sagittal Craniosynostosis
Endoscopic strip craniectomy (ESC) with post-operative helmeting is the gold-standard treatment for isolated, non-syndromic sagittal craniosynostosis in children under 6 months of age as it is has been demonstrated to reduce…
- Trial name
- NCT04721769
- Testing
- Endoscopic strip craniectomy (with lateral osteotomies) with post-operative helmet therapy, Endoscopic strip craniectomy (without lateral osteotomies) with post-operative helmet therapy
- Where
- United States
- Volunteers
- 6 people
- Sponsor
- Baylor College of Medicine
Metopic Synostosis
Comparing Conservative to Surgical Treatment of Trigonocephaly Craniofacial Surgery in Children With Trigonocephaly: an Observational Cohort Study on Clinical Outcomes, Psychosocial Wellbeing, and Costs
RESEARCH QUESTION Is the effectiveness of conservative policy comparable to that of surgery in children with trigonocephaly, with regard to clinical outcomes and psychosocial functioning, stress for parents, and costs? DESIGN…
- Trial name
- Treat Trigono (NCT06069479)
- Testing
- craniofacial surgery
- Where
- Netherlands
- Volunteers
- 440 people
- Sponsor
- Erasmus Medical Center
Plagiocephaly, Positional, Plagiocephaly, Nonsynostotic
Effectiveness of Ottobock Helmet Therapy in Infants With Plagiocephaly, Brachycephaly or Combination of Both
The objective of the research is to measure the effectiveness of the Ottobock helmet, an innovative 3D-printed cranial orthosis used to correct infant cranial positional deformation: plagiocephaly, brachycephaly or combination of…
- Conditions
- Plagiocephaly, Positional, Plagiocephaly, Nonsynostotic, Brachycephaly
- Trial name
- NCT05154175
- Testing
- Ottobock helmet
- Where
- 12 sites in France
- Volunteers
- 452 people
- Sponsor
- Otto Bock France SNC