Clinical trials: Craniosynostosis
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
Tumor or Lymphoma
A Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of JNJ-42756493 in Adult Participants With Advanced or Refractory Solid Tumors or Lymphoma
The purpose of this study is to evaluate the safety, pharmacokinetics (study of what the body does to a drug), and pharmacodynamics (study of what a drug does to the body) of JNJ-42756493, a pan-fibroblast growth factor receptor…
- Trial name
- NCT01703481
- Testing
- JNJ-42756493: Part 1, JNJ-42756493: Part 2, JNJ-42756493: Part 3
- Where
- 37 sites in United States, France and 1 more
- Volunteers
- 188 people
- Sponsor
- Janssen Research & Development, LLC
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
Breast Neoplasms
A Study of E7090 as Monotherapy and in Combination With Other Anticancer Agents in Participants With Estrogen Receptor Positive (ER+) and Human Epidermal Growth Receptor 2 Negative (HER2-) Recurrent/Metastatic Breast Cancer
The primary purpose of this study is to evaluate the tolerability and safety of E7090 as monotherapy and in combination with other anticancer agents in participants with ER+, HER2- recurrent/metastatic breast cancer and to…
- Trial name
- NCT04572295
- Testing
- E7090, Fulvestrant, Exemestane
- Where
- 11 sites in Japan
- Volunteers
- 51 people
- Sponsor
- Eisai Co., Ltd.
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
Hypovolemia, Craniosynostoses
Bedside Resources to Gauge Intravascular Volume Status
The goal if this study is to employ the CardioQ-Esophageal Aortic Doppler probe to define fluid responders from non-responders among infants undergoing cranial vault reconstruction for craniosynostosis.
- Trial name
- NCT03915587
- Testing
- CardioQ-EDM and CipherOx-CRI
- Where
- United States
- Volunteers
- 23 people
- Sponsor
- University of Colorado, Denver
Craniosynostosis
Comparing MRI to CT on Pediatric Craniosynostosis.
The purpose of this study is to develop and test the effectiveness and diagnostic quality of Zero Echo Time Magnetic Resonance Imaging (ZTE MRI) in comparison to CT.
- Trial name
- NCT04704284
- Testing
- Zero Echo Time Magnetic Resonance Imaging (ZTE MRI)
- Where
- United States
- Volunteers
- 12 people
- Sponsor
- Mayo Clinic
Craniosynostosis Patients Undergoing Distraction Osteotomy
Effect of Tranexamic Acid Based on Pharmacokinetics in Pediatric Patients Undergoing Craniosynostosis Surgery: Randomized Controlled Trial
Massive bleeding is expected when performing distraction osteotomy for craniosynostosis patients. Since such operation is performed at very young age, many efforts are performed in order to reduce the total amount of bleeding and…
- Trial name
- NCT02180321
- Testing
- Tranexamic Acid, normal saline
- Where
- South Korea
- Volunteers
- 50 people, healthy volunteers welcome
- Sponsor
- Yonsei University
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.
Plagiocephaly
Postural Assessment in Plagiocephaly
The positional plagiocephaly is a condition involving craniofacial asymmetry. The purpose of this study is to evaluate the spine, the posture and the psychomotor state in children who were diagnosed with infant plagiocephaly.
- Trial name
- NCT01989286
- Testing
- Assessment
- Where
- Spain
- Volunteers
- 104 people, healthy volunteers welcome
- Sponsor
- Universidad de Granada
Marfan Syndrome, Turner Syndrome
National Registry of Genetically Triggered Thoracic Aortic Aneurysms and Cardiovascular Conditions
The National Registry of Genetically Triggered Thoracic Aortic Aneurysms and Cardiovascular Conditions (GenTAC) was initiated in 2006 by the National Heart, Lung, and Blood Institute (NHLBI) and the National Institute of…
- Conditions
- Marfan Syndrome, Turner Syndrome, Ehlers-Danlos Syndrome, Loeys-Dietz Syndrome
- Trial name
- GenTAC (NCT01322165)
- Where
- 7 sites in United States
- Volunteers
- 3,706 people
- Sponsor
- National Heart, Lung, and Blood Institute (NHLBI)
Craniosynostosis, Bleeding
Tranexamic Acid for Craniofacial Surgery
This is a randomized, blinded, prospective study that will investigate the potential benefit of tranexamic acid to reduce the intraoperative bleeding and blood transfusions in pediatric patients undergoing craniofacial surgeries.
- Trial name
- NCT00722436
- Testing
- Tranexamic acid, saline
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- University of Pittsburgh
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
Craniosynostoses, Pain, Postoperative
Scalp Block Decreases Pain and Side Effects
Postoperative analgesia after corrective surgery of paediatric craniosynostosis is crucial in term of short and long-term outcomes.
- Trial name
- NCT04133467
- Testing
- scalp block
- Where
- Italy
- Volunteers
- 26 people
- Sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS
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
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
UC (Urothelial Cancer)
A Study to Evaluate the Efficacy and Safety of Pemigatinib (INCB054828) in Subjects With Urothelial Carcinoma - (FIGHT-201)
The purpose of this study is to evaluate the overall response rate (ORR) of pemigatinib as a monotherapy in the treatment of metastatic or surgically unresectable urothelial carcinoma harboring FGF/FGFR alterations.
- Trial name
- NCT02872714
- Testing
- pemigatinib
- Where
- 96 sites in United States, Belgium and 9 more
- Volunteers
- 263 people
- Sponsor
- Incyte Corporation
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
Craniosynostosis, Muenke Syndrome
Clinical Study of Muenke Syndrome (FGFR3-Related Craniosynostosis)
This study will explore the range and type of medical and developmental problems in patients with Muenke syndrome, a condition that results when one or more of the suture between the bones of the skull close before birth.
- Trial name
- NCT00106977
- Where
- 2 sites in United States
- Volunteers
- 137 people
- Sponsor
- National Human Genome Research Institute (NHGRI)
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