Clinical trials: Craniosynostoses, open to volunteers
Prader-Willi Syndrome, PWS-like Syndrome
GROWing Up With Rare GENEtic Syndromes
Introduction Rare complex syndromes Patients with complex genetic syndromes, by definition, have combined medical problems affecting multiple organ systems, and intellectual disability is often part of the syndrome.
- Conditions
- Prader-Willi Syndrome, PWS-like Syndrome, Silver Russel Syndrome, Congenital Hypopituitarism
- Trial name
- GROW UR GENES (NCT04463316)
- Testing
- Retrospective file studies
- Where
- Netherlands
- Volunteers
- 600 people
- Sponsor
- dr. Laura C. G. de Graaff-Herder
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
Advanced or Recurrent Solid Tumors, FGFR Gene Alterations
NCCH2006/MK010 Trial (FORTUNE Trial)
This is a single-arm, open-label, multicenter, investigator-initiated Phase 2 trial to evaluate the efficacy and safety of E7090 in patients with advanced or recurrent solid tumors harboring FGFR genetic alterations (including…
- Trial name
- NCT04962867
- Testing
- E7090
- Where
- 7 sites in Japan
- Volunteers
- 75 people
- Sponsor
- National Cancer Center, Japan
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
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
Biliary Tract Cancer
Futibatinib (TAS-120) in Patients With Advanced Biliary Tract Cancer
To compare overall survival (OS) of patients in Futibatinib and Zimberelimab in Combination with Gemcitabine plus Cisplatin versus Durvalumab or Pembrolizumab in Combination with Gemcitabine plus Cisplatin for patients with…
- Trial name
- FOENIX-BTC (NCT07710885)
- Testing
- Futibatinib, Zimberelimab, Durvalumab
- Where
- 21 sites in Australia, Japan and 2 more
- Volunteers
- 784 people
- Sponsor
- Taiho Pharmaceutical Co., Ltd.
Craniosynostoses, Hypovolemia
Hemodynamic Monitoring During Craniosynostosis Surgery: Comparing Traditional and Newer Technology Monitors (CRASY-PRAM)
Hemodynamic evaluation during pediatric anesthesia is essential to care management. Intraoperative cardiovascular instability is frequent in major surgeries, and appropriate monitoring is necessary to ensure safe anesthetic…
- Conditions
- Craniosynostoses, Hypovolemia, Hemorrhage, Hemodynamic Instability
- Trial name
- CRASY-PRAM (NCT06263075)
- Testing
- Intraoperative monitoring
- Where
- Italy
- Volunteers
- 30 people
- Sponsor
- IRCCS Azienda Ospedaliero-Universitaria di Bologna
Craniosynostoses, Crouzon Syndrome
ASO Treatment for Syndromic Craniosynostoses
Syndromic craniosynostoses (SCS) are rare genetic disorders defined by premature cranial suture fusion, resulting in abnormal craniofacial development and constrained brain growth.
- Conditions
- Craniosynostoses, Crouzon Syndrome, Saethre Chotzen Syndrome, Muenke Syndrome
- Trial name
- NAUTILUS (NCT07535372)
- Testing
- Design of patient specific ASO
- Where
- Italy
- Volunteers
- 12 people
- Sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS
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
Craniosynostosis
Pleth Variability Index Monitoring in Pediatric Craniosynostosis Surgery
This prospective observational study aims to evaluate the role of pleth variability index (PVI) and perfusion index (PI) monitoring in intraoperative hemodynamic control among pediatric patients undergoing craniosynostosis…
- Trial name
- PVI-CRANIO (NCT07657598)
- Where
- Turkey (Türkiye)
- Volunteers
- 30 people
- Sponsor
- Muzaffer GENCER
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
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
Plagiocephaly, Brachycephaly
Cranial Remolding Orthosis Registry
A registry of infants fitted with a cranial remolding orthosis.
- Conditions
- Plagiocephaly, Brachycephaly, Asymmetric Head
- Trial name
- NCT06762691
- Testing
- MyCRO Band, Traditional CRO
- Where
- United States
- Volunteers
- 500 people
- Sponsor
- Otto Bock HealthCare LP
Craniosynostosis, Anesthesia
Influence of General Anesthesia on the Dynamic Changes in Brain Damage Markers During and After Craniosynostosis Operations in Infancy
The issue of anesthetics neurotoxicity is one of the most discussed topics in pediatric anesthesiology, thus it opens the question of the safety of commonly used anesthetics in the pediatric patient.
- Trial name
- TAnBrainDam (NCT05911139)
- Where
- Slovakia
- Volunteers
- 45 people
- Sponsor
- Comenius University
Craniosynostoses
Burosumab and 1-25 (OH) Vitamin D on Human Osteoblasts
FGF23 is the cornerstone of phosphate / calcium / vitamin D metabolism: it is synthesized mainly by osteocytes and acts as a phosphaturizing agent, inhibitor of dihydroxyvitamin D, and inhibitor of synthesis and secretion of PTH…
- Trial name
- HYPO-BLASTES (NCT04159675)
- Testing
- osteoblast biology study
- Where
- France
- Volunteers
- 20 people
- Sponsor
- Hospices Civils de Lyon
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
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
Craniostenosis
Multimodal Mechanical, Tissue, Architectural, and Histological Evaluation of the Bone and Sutures of the Parietal Bone in an Infant With Craniosynostosis.
The human skull is a complex structure that protects the underlying tissues, including the brain. Certain rare conditions and diseases, such as craniosynostosis-which affects 1 in 2,000 to 2,500 children-impair these functions…
- Trial name
- CRANIOMECA (NCT07650981)
- Testing
- Biological sample, bones sample and questionaires.
- Where
- France
- Volunteers
- 80 people
- Sponsor
- Hospices Civils de Lyon
Renal Cell Carcinoma Metastatic, Prostate Cancer Metastatic
A Phase 1b/2 Study of the Safety and Efficacy of the Monoclonal Antibody OM-RCA-01 in Patients With Metastatic Tumors Expressing Fibroblast Growth Factor Receptor 1
One of the most relevant targets in the field of novel targeted anticancer therapy is the family of receptors to fibroblast growth factor receptors (FGFRs). FGFR1 is the main representative of the FGFR family.
- Conditions
- Renal Cell Carcinoma Metastatic, Prostate Cancer Metastatic, Non-small Cell Lung Cancer Metastatic, Breast Cancer Metastatic
- Trial name
- TAGNOT (NCT07292168)
- Testing
- humanized monoclonal anti-FGFR1 antibody OM-RCA-01
- Where
- 5 sites in Russia
- Volunteers
- 58 people
- Sponsor
- Kidney Cancer Research Bureau
Craniosynostosis, Strabismus
Ocular Characteristics in Patients With Craniosynostosis
Craniosynostosis are cranial deformations due to the premature closure of one or more cranial sutures. These deformations affect approximately one in 2.500 births.
- Conditions
- Craniosynostosis, Strabismus, Intracranial Hypertension, Amblyopia
- Trial name
- COPACA (NCT06928727)
- Where
- France
- Volunteers
- 65 people
- Sponsor
- Centre Hospitalier Universitaire, Amiens