View clinical trials related to Congenital Abnormalities.
Filter by:The HEART-AI (Harnessing ECG Artificial Intelligence for Rapid Treatment and Accurate Interpretation) is an open-label, single-center, randomized controlled trial, that aims to deploy a platform called DeepECG at point-of-care for AI-analysis of 12-lead ECGs. The platform will be tested among healthcare professionals (medical students, residents, doctors, nurse practitioners) who read 12-lead ECGs. In the intervention group, the platform will display the ECHONeXT structural heart disease (SHD) scores in randomized patients to help doctors prioritize TTEs (Supplemental Table 2, Figure 1). Also, this platform will display the DeepECG-AI interpretation which detects problems such as ischemic conditions, arrhythmias or chamber enlargements and acts an improved alternative to commercially available ECG interpretation systems such as MUSE (Supplemental Table 1). The performance for both of these models is presented in supplemental appendix (Supplemental Table 1, Supplemental Table 2, Supplemental Figure 1). Our primary objective is to assess the impact of displaying the ECHONeXT interpretation on 12-lead ECGs, specifically focusing on the detection rates of Structural Heart Disease (SHD) on TTE among newly referred patients at MHI and on the delay between the time of the first ECG opened in the platform and the TTE evaluation among newly referred patients at MHI at high or intermediate risk of SHD, by comparing patients in the intervention (ECHONeXT prediction of SHD displayed and recommendation on the priority to assign to the TTE) arm and patients in the control (ECHONeXT prediction and recommendation hidden) arm. The main secondary objective is to evaluate the proportion of ECGs where the users agree with the DeepECG diagnosis, across all ECGs accessed by the user of the platform. By integrating an AI-analysis platform at the point of care and evaluating its impact on ECG interpretation accuracy and prioritization of incremental tests, the HEART-AI study aims to provide valuable insights into the potential of AI in improving cardiac care and patient outcomes.
This study investigates muscle agenesis, specifically the absence of the palmaris longus and plantaris muscles, and its effects on injury risk, strength, and performance. Muscle injuries are common in sports, and the presence or absence of certain muscles can impact biomechanics and injury susceptibility. The study involves 132 subjects, divided into those with and without muscle agenesis, assessing injuries with the Nordic and CMDQ questionnaires and measuring strength with dynamometers. Results aim to clarify the controversial impact of muscle agenesis on functional disability and performance adaptation in the scientific literature.
To evaluate the role of ultrasound in prenatal diagnosis of congenital anomalies of kidney and urinary system in third trimester of pregnancy. Primay outcomes: To determine incidence of congenital anomalies in kidney and urinary system in Third Timerter by ultrasound.
The absence of surgery of Congenital lung malformations (CLMs), if it avoids a stressfull event, is accompanied by a "medicalization" of the child, which will be regularly followed up in a specialized medical and surgical environment. The persistent risk of complication, albeit low, is likely to induce over-protective parental behaviours, and to be associated with a sustained family anxiety reaction. The main objective is to test the hypothesis that the absence of surgery has a significant impact on parental anxiety, measurable at 6- 9 years of age.
This study aims to retrospectively collect data from routine clinical practice in order to evaluate the safety profile of the Agile intramedullary nail, used in pediatric patients according to the manufacturer Instructions For Use (IFU) in the time frame from the time of surgery until the last follow-up visit available at the hospitals.
The goal of this observational study is to examine and confirm the clinical performance of the Fitbone Transport and Lengthening System in adult patients (21 years and older) who require lower-limb lengthening, fracture fixation and/or treatment for previous non-healing fracture. The main questions it aims to answer are: 1. Are their any unanticipated safety issues with the product when used in a real-world setting? 2. Does the product provide the anticipated clinical benefit when used in a real-world setting? Participants will have been selected by their physician to be treated with the Fitbone Transport and Lengthening System as part of treatment for their condition or injury. All procedures will be according to the physician's standard care practices. There are no study-specific procedures or requirements for participants in this study.
Delineate coronary artery anatomy and detection of coronary anomalies in children with complex cardiac anomalies by cardiac CT-angiography before total surgical correction.
Virtual Surgical Planning (VSP), Computer-Aided Surgical Simulation (CASS) for bone corrections, and the customization of implants and devices through 3D printing, known as Patient-Specific Instruments (PSI) and Graft-Specific Instruments (GSI), are assuming increasingly central roles in orthopedic clinical and surgical practice. One area witnessing notable advancement is the treatment of musculoskeletal disorders (MMS) in children, adolescents, and young adults. These disorders involve severe and rare abnormalities in skeletal formation and development across three-dimensional planes, often affecting multiple limbs. Managing such deformities is complex, challenging to standardize, and prone to unpredictable clinical, radiographic, and functional outcomes. The application of 3D modeling and printing technologies offers a deeper understanding of deformities and facilitates improved prediction, precision, reproducibility, and safety in surgical interventions. The Musculoskeletal Apparatus Network (RAMS Network) centers are equipped with advanced 3D laboratories for surgical simulation and planning, aligned with the overarching goal of improving surgery quality through "in-silico" medicine (ISM) principles. At present, numerous complex surgeries involving Virtual Surgical Planning (VSP) and sterilizable 3D-printed Patient-Specific Instruments (PSI) and/or Graft-Specific Instruments (GSI) are being simulated and performed at the Rizzoli Institute. Preliminary data from previous protocols indicate a significant reduction in surgical time with the implementation of VSP and the utilization of PSI and GSI. The aim of this study is to enhance the current process of simulating, planning, and designing surgical support tools within 3D Printing Point-of-Care (3D POC) facilities. To achieve this, it is imperative to expand case volumes and systematically organize, categorize, and standardize simulation and planning procedures.
The aim of this study is to investigate the effects of Schroth exercises and kinesiological taping on spinal deformities and serum markers in young adults with scoliosis. The study will include young adults aged 18-21 with scoliosis. A total of 57 participants will be included in the study. Out of 57 participants, 38 have scoliosis, and 19 are healthy. 38 participants will be randomly divided into 2 groups. One group (n=19) will receive only Schroth exercises, and the other group (n=19) will receive both Schroth exercises and kinesiological taping. The laboratory analyses of proteins associated with autophagy (Beclin-1, LC3, and ATG3) and bone-cartilage metabolism (COMP and MMP-3) will be conducted in the Biomedical Engineering Laboratory of our university. Trunk rotation will be assessed using the Adams Forward Bend Test with scoliometer, quality of life will be evaluated with the SRS-22 Quality of Life questionnaire and Quality of life profile for spinal deformities questionnaire, perception of deformity will be measured using the Walter Reed Visual Assessment Scale, and Cobb angles will be evaluated from anterior-posterior X-ray images.
The goal of this observational study is to study the genetic landscape in patients with Plasma Cell Disorders including MGUS, SMM, MM, and amyloidosis in Thailand. The main questions it aims to answer are: - genetic landscape in patients with Plasma Cell Disorders including MGUS, SMM, MM, and amyloidosis in Thailand who were performed FISH and/or NGS testing - genetic correlation and genetic dependency between FISH and NGS, stratified by high- and standard-risk groups based on FISH testing in Thai MM patients. - disease characteristics and response rates in MM patients with cytogenetic abnormalities detected by FISH and/or genetic mutations detected by NGS. - correlation between cytogenetic abnormalities identified by FISH and genetic mutations detected by NGS with progression-free survival in MM patients. The FISH and/or NGS testing results, disease characteristics, treatment, and treatment outcomes of patients with plasma cell disorders who underwent FISH and/or NGS testing before IRB approval will be collected through retrospective chart review. Subsequently, data will be gathered prospectively. Participants will provide approximately 12 mL of bone marrow fluid for FISH and NGS testing.