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Congenital Abnormalities clinical trials

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NCT ID: NCT06224985 Completed - Tumor Clinical Trials

Computational Anatomy in Surgery for Childhood Tumours and Malformations

IMAG2
Start date: April 16, 2016
Phase:
Study type: Observational

This study is part of the launch of a multidisciplinary project called IMAG2, for image-guided minimally invasive surgery. It involves collaboration between the radiology and surgery teams at Necker Hospital and the Image Processing and Interpretation (TII) team at the LTCI at Télécom ParisTech. To make a decision, surgeons need access to a 3D model reflecting the anatomy of the specific patient and its pathological variations. Patient-specific 3D reconstruction provides a significant improvement, leading to a precise assessment of the malformation or tumour and its relationship with surrounding organs, nerves and vessels. It allows the surgeon to simulate a pre-operative procedure, which is a definite advantage in terms of safe, effective and curative surgery, particularly in oncology. MRI has been chosen as the basic imaging technique because of its non-irradiating nature and the current lack of 3D MRI reconstruction technology. The study aims to provide an aid to diagnosis and surgical planning by developing dedicated methods and algorithms for segmenting not only the tumour but also the main anatomical components surrounding the tumour from 3D MRI imaging data. The imaging will be performed on a 3 Tesla MRI. The data will be that required for diagnosis and surgical planning, acquired on a routine clinical basis with an expected benefit for patients.

NCT ID: NCT06223737 Not yet recruiting - Spine Deformity Clinical Trials

Spine Deformity Patients With Optoelectronic Motion Capture

Start date: June 1, 2024
Phase: N/A
Study type: Interventional

Aging-induced changes in the spine can lead to adult spinal deformity, causing a forward and/or lateral shift of the trunk. While mild cases may have compensatory mechanisms, severe deformities necessitate treatment. Surgery with instrumentation effectively corrects deformities, but complications are common. Precise pre-operative planning based on X-rays is essential. However, radiological imaging has limitations, including ionizing radiation exposure and static nature. Marker-based optoelectronic motion analysis systems offer potential benefits for dynamic spine assessment. This study aims to test the feasibility of using motion analysis systems to characterize spinal alignment and balance in patients with adult spine deformity. The primary objective is to assess the practical implementation, measurement capability, and resources required for motion analysis. Secondary objectives include investigating errors in absolute spinal curvature assessment and developing compensation strategies. The project will recruit 20 patients (non-operated and operated) seeking medical attention for adult spine deformities and 10 healthy controls. Participants will undergo biplanar imaging and motion analysis to capture static and dynamic spine alignment during common activities. The data will help build patient-specific musculoskeletal models, offering potential insights into improving surgical planning for adult spine deformities.

NCT ID: NCT06211504 Recruiting - Flexible Flatfoot Clinical Trials

Sinus Tarsi Implant as an Adjuvant Procedure to Medial Displacement Calcaneal Osteotomy in the Treatment of Mobile Adult Acquired Flatfoot Deformity

Start date: April 11, 2024
Phase: Phase 4
Study type: Interventional

Background: Adult acquired flatfoot deformity (AAFD) is a deformity of the foot which leads to pain and an altered gait pattern. There are several different surgical interventions available for treatment of AAFD. One of the most common treatments for mobile AAFD is medial displacement calcaneal osteotomy (MDCO) with or without adjuvant soft tissue procedures. However, the medial displacement of the calcaneus only aims to correct the deformity in one plane despite AAFD being a deformity of three planes with hypereversion of the calcaneus, anterior translation of the talus over the calcaneus and tilting/drop of the calcaneal head. Because of these multiple forces, the healing of MDCO in the intended position can sometimes be hard to achieve and medial soft tissue is still stressed leading to recurring deformity. The investigators believe that adjuvant insertion of a sinus tarsi implant (STI) could work as an internal splint, protecting soft tissue procedures on the medial side, reversing anterior translation of the talus, opposing calcaneus eversion, and lifting talar head. This additional procedure will create a better correction of the deformity with enhanced appearance of the foot and better long-term functional results. Methods: This is a multi-center randomized controlled trial designed to assess the efficacy of STI as an adjuvant procedure to MDCO in patients with mobile AAFD (Stage IIA). Patients aged 16 to 75 years, referred to one of the orthopedic centers involved in this study, will be invited to participate if they fulfil the trials eligibility criteria. In total, 130 patients who provide informed consent will be randomized to either MDCO with STI or MDCO without STI (65 patients in each group). The included patients will be clinically and radiographically examined. They will also fill out a form before surgery and 4-5 months, 1 year and 2 years postoperatively. The form will include Self-Reported Foot and Ankle Score (SEFAS) and Euro-QoL 5 Dimensions (EQ-5D). The trials primary outcome will be change in Meary's angle. Secondary outcomes include additional radiographic changes, change in SEFAS score, EQ-5D index, pain according to visual analog scale (VAS), satisfaction assessment, clinical outcome measures, the length of postoperative sick-leave and rate of complications. Discussion: This is the first randomized controlled trial assessing the efficacy of a sinus tarsi implant as an adjuvant procedure to MDCO.

NCT ID: NCT06209775 Completed - Clinical trials for Liver Transplantation

Impact of Perioperative Body Composition Abnormalities on Patient Outcomes After Liver Transplantation

Start date: January 1, 2015
Phase:
Study type: Observational

Accumulating evidence suggests the prognostic significance of body composition in chronic diseases and neoplastic diseases. CT imaging-based body composition abnormalities are significantly associated with post-LT adverse outcomes including decreased quality of life (QOL), impaired graft regeneration and mortality. However, the perioperative changes in body composition and their potential clinical implications remain unexplored. The objective of this study is to systematically explore and clarify the correlation between body composition and the prognosis of liver transplant patients through dynamic peri-transplant mornitoring.

NCT ID: NCT06197789 Completed - Clinical trials for Tear Trough Eyelid Deformity

Safety and Efficacy Study of TPX-105 for Correction of Nasojugal Groove

Start date: August 18, 2021
Phase: Phase 3
Study type: Interventional

Nasojugal groove correction is possible through surgical correction procedures, however, due to risks in safety and drawbacks not being able to be done on the young or after surgical procedure, dermal fillers which have the possibility of granulomatous allergic reaction and surface elevation. Therefore, there is a need for a safer procedure for nasojugal groove correction. This study evaluates the safety and efficacy of Autologous human dermal fibroblasts (TPX-105) used for the correction of nasojugal groove. The primary outcome is the improvement of nasojugal groove evaluated by an independent evaluator after administration of TPX-105 at week 24. Secondary outcomes include the improvement of nasojugal groove at week 4 and 12, severity change from baseline at week 4, 12 and 24 evaluated by an independent evaluator, and overall appearance improvement rate rated by subjects using Global Aesthetic Improvement Scale (GAIS) at week 4, 12, 24 and 48.

NCT ID: NCT06189092 Recruiting - Clinical trials for Vascular Malformations

Treatment of Low-flow Venous Malformations With Electrosclerotherapy. Prospective Observational Study

BESVAM
Start date: October 28, 2023
Phase:
Study type: Observational [Patient Registry]

Venous malformations (MVs) are congenital abnormalities of the central or periphery caused by developmental errors at different stages of embryogenesis. Histologically they are characterized by large, venous-like vascular spaces. Scleroembolization constitutes the most widespread method in the treatment of venous malformations allowing good results with low invasiveness. Currently, Bleomycin (and its derivatives) is among the most widely used sclerosing agents for slow-flowing vascular malformations (venous and lymphatic malformations) because of the low rate of local serious adverse events such as swelling, necrosis, and nerve injury compared with others.

NCT ID: NCT06188104 Withdrawn - CIN1 Clinical Trials

Efficacy of Topical 95% TCA in the Treatment of CIN 1 or Less After Low-grade Abnormality of Screening Test

Start date: November 30, 2023
Phase: Phase 2/Phase 3
Study type: Interventional

To evaluate the efficacy of topical 95% TCA in the treatment of CIN 1 or less after low grade abnormality of screening test

NCT ID: NCT06185140 Not yet recruiting - Clinical trials for Heart Defects, Congenital

Effects of Rehabilitation Programme on Respiratory Function in Patients With Acquired and Intervened Congenital Heart Disease.

Start date: January 1, 2024
Phase: N/A
Study type: Interventional

Congenital heart defects (CHDs) are heart malformations that occur before birth, and they represent one of the leading causes of neonatal morbidity and mortality. they occur in approximately 1% of newborns and are associated with high morbidity and mortality rates. The etiology of these cardiac anomalies is mostly unknown. around 70-80% of cases are generated by the involvement of multiple affected genes combined with an environmental trigger that, when acting on a susceptible individual, promotes the expression of the damaged genome. maternal diseases during pregnancy or exposure to teratogenic substances are also implicated in the etiology.

NCT ID: NCT06183853 Recruiting - Clinical trials for Maxillofacial Abnormalities

Evaluation of the Long-term Results of Extended Supra-basillary Genioplasty of the "Chin Wing" Type Without Bone Graft

SASCWatch
Start date: September 5, 2022
Phase:
Study type: Observational

The correction of maxillomandibular dysmorphoses, responsible for both functional discomfort (lip incompetence, ventilation disorders, periodontal disease) but also aesthetic, calls in particular for genioplasty, of which there are several techniques. One of these chin repositioning techniques, called "Chin Wing", cuts the bone to optimize the functional and aesthetic result. While all genioplasty techniques expose the risk of nerve damage and lack of bone consolidation, these parameters are only rarely addressed in the literature in the specific context of this extensive bone cutting. The objective of this work is to assess the satisfaction of patients who have benefited from chin advancement surgery using the "Chin Wing" technique.

NCT ID: NCT06178887 Recruiting - Turner Syndrome Clinical Trials

Role of Cardiac AngioMR in Diagnosis of Cardiac and Vascular Anomalies in Adult Patients With Turner Syndrome

Start date: January 8, 2019
Phase:
Study type: Observational

Considering the high prevalence of cardiovascular disease in Turner syndrome patients, noninvasive cardiac imaging is crucial for diagnosis and follow-up. From the review of the literature, it was evident that the imaging techniques used involved the evaluation of only the thoracic findings, in particular the heart and the thoracic aorta, while no data are currently available on the distal abdominal aorta or iliac arteries, since ultrasound and MRI are interrupted at the diaphragmatic level.