Clinical trials: Craniosynostosis
Craniosynostoses
Clinical Feasibility Study of Preoperative Surgical Planning
Most children diagnosed with craniosynostosis undergo a relatively extensive cranial vault remodeling procedure. The decision of performing surgical cranial shape correction for patients with craniosynostosis typically rests on a…
- Trial name
- NCT03812159
- Testing
- iCSPlan
- Where
- United States
- Sponsor
- Gary F. Rogers, MD
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
Craniosynostoses
Blood Loss and Transfusion Requirement in Infants Treated With Tranexamic Acid
The primary objective of this study is to investigate whether tranexamic acid (TXA) reduces perioperative blood loss and transfusion requirement in infants undergoing craniosynostosis surgery.
- Trial name
- NCT01094977
- Testing
- Tranexamic Acid
- Where
- Canada
- Volunteers
- 90 people
- Sponsor
- The Hospital for Sick Children
Craniosynostosis, Philadelphia Type Craniosynostosis
Genetic Analysis of Craniosynostosis, Philadelphia Type
This study will try to find the gene changes responsible for the birth defects in craniosynostosis, Philadelphia type. Craniosynostosis syndromes are a group of conditions that result from closure of one or more of the fibrous…
- Trial name
- NCT00367796
- Where
- United States
- Volunteers
- 25 people
- Sponsor
- National Human Genome Research Institute (NHGRI)
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
Gastric Adenocarcinoma
Derazantinib Alone or in Combination With Paclitaxel, Ramucirumab or Atezolizumab in Gastric Adenocarcinoma
The purpose of this study was to evaluate the efficacy of derazantinib monotherapy or derazantinib in combination with paclitaxel and ramucirumab in patients with gastric adenocarcinoma (GAC) i.e.
- Trial name
- FIDES-03 (NCT04604132)
- Testing
- Derazantinib, Derazantinib-paclitaxel-ramucirumab combination
- Where
- 81 sites in United States, Argentina and 13 more
- Volunteers
- 47 people
- Sponsor
- Basilea Pharmaceutica
Craniofacial Differences
Positive Exposure: A Photography and Video Intervention for Individuals With Craniofacial Differences
This study will describe the use of an intervention, developed by an organization called Positive Exposure, to improve self-perceptions among adolescents and young adults who may encounter the stigma, or negative effect, of…
- Trial name
- NCT00340964
- Where
- United States
- Volunteers
- 44 people
- Sponsor
- National Human Genome Research Institute (NHGRI)
Craniosynostosis
Network Of Clinical Research Studies On Craniosynostosis, Skull Malformations With Premature Fusion Of Skull Bones
Craniosynostosis (CS) is a common malformation occurring in ~4 per 10,000 live births in which the sutures between skull bones close too early, causing long-term problems with brain and skull growth.
- Trial name
- NCT03025763
- Testing
- Craniosynostosis Network Environmental Survey, 2D/3D Photography, Buccal Swab Cell Sampling
- Where
- 20 sites in United States, France and 3 more
- Volunteers
- 2,145 people, healthy volunteers welcome
- Sponsor
- Icahn School of Medicine at Mount Sinai
Deformational Plagiocephaly, Deformational Posterior Plagiocephaly
Effectiveness of Repositioning and Cranial Remolding in Infants With Cranial Deformation
This study will examine how effective caregiver's repositioning strategies are in correcting an infant's deformational cranial shape, as well as the effectiveness of the use of a custom cranial remolding orthosis for treatment of…
- Conditions
- Deformational Plagiocephaly, Deformational Posterior Plagiocephaly, Brachycephaly, Torticollis
- Trial name
- NCT05917678
- Testing
- Repositioning Therapy, Cranial Remolding Orthosis
- Where
- United States
- Volunteers
- 65 people, healthy volunteers welcome
- Sponsor
- University of Texas Southwestern Medical Center
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.
Non Synostotic Plagiocephaly
Head Circumference Evolution in Children With Positional Plagiocephaly During and After Molding Helmet Therapy.
The aim of this study is to verify the growth of cranial circumference in children treated with helmets for positional skull deformity.
- Trial name
- PCPlagio (NCT06956768)
- Volunteers
- 150 people
- Sponsor
- Central Hospital, Nancy, France
Urothelial Cancer, Receptors, Fibroblast Growth Factor
A Study to Identify Participants With Urothelial Cancer and Fibroblast Growth Factor Receptor Gene Aberrations
The purpose of this non-interventional study is to identify participants with urothelial cancer (UC) and selected fibroblast growth factor receptor (FGFR) aberrations through molecular testing of their archival tumor tissue.
- Trial name
- NCT03955913
- Testing
- Archival Tumor Tissue Sample
- Where
- 199 sites in United States, Argentina and 12 more
- Volunteers
- 3,679 people
- Sponsor
- Janssen Research & Development, LLC
Neuromuscular Blocking Agents, Residual Neuromuscular Block
Measuring of the Duration of Action of Different Doses of Rocuronium-induced Neuromuscular Block in Infants During Surgical Treatment of Craniosynostosis
The use of intravenous muscle relaxants during anaesthesia can significantly facilitate endotracheal intubation and reduce the chance of possible airway complications during intubation.
- Conditions
- Neuromuscular Blocking Agents, Residual Neuromuscular Block, Neuromuscular Blockade Monitoring
- Trial name
- NCT07080528
- Testing
- Sevofluorane, Propofol
- Where
- Hungary
- Volunteers
- 20 people
- Sponsor
- Tamas Vegh, MD
Optic Nerve Sheath Diameter
Optic Nerve Sheath Diameter in Craniosynostosis
Changes of optic nerve sheath diameter after position changes
- Trial name
- ONSD (NCT03131245)
- Where
- South Korea
- Volunteers
- 30 people
- Sponsor
- Seoul National University Hospital
Craniosynostoses
Craniosynostosis :Surgical Treatment Modalities and Outcome
Aim of study: 1. To evaluate outcome of cases( cosmoses and cognition) after Craniosynostosis surgery 2. - To ascertain intra- and postoperative complications
- Trial name
- NCT05511168
- Testing
- Craniostnostosis surgery
- Volunteers
- 24 people, healthy volunteers welcome
- 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
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
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
Craniosynostosis
MRI for Non-invasive Evaluation of Brain Stress
Craniosynostosis is a birth defect that causes the bones on a baby's head to fuse together earlier than normal. This causes the baby to have an abnormally shaped head.
- Trial name
- NCT01898650
- Testing
- MR scan
- Where
- United States
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- Washington University School of Medicine
Plagiocephaly, Brachycephaly
Monitoring System for Cranial Orthoses
This is a study which investigates the wear time and fit of a cranial remolding orthosis (a standard-of-care treatment where an infant wears a custom helmet to help reshape their head as they grow).
- Conditions
- Plagiocephaly, Brachycephaly, Deformational Plagiocephaly, Deformational Posterior Plagiocephaly
- Trial name
- NCT06425172
- Testing
- Cranial Remolding Orthosis
- Where
- United States
- Volunteers
- 12 people
- Sponsor
- University of Texas Southwestern Medical Center