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NCT ID: NCT06415916 Not yet recruiting - Volume Expander Clinical Trials

Ultrasound and Clinical Approach for the Dynamic Assessment of Fluid Tolerance in the Intensive Care Unit

FLUID-REACT
Start date: June 2024
Phase:
Study type: Observational

A major cause of admission to intensive care is acute circulatory failure resulting from organ hypoperfusion due to factors such as hypotension and myocardial dysfunction. The standard treatment, including volume expansion and vasopressor/inotropic agents, often leads to water and sodium overload, increasing the risk of morbidity and mortality in the ICU. The combination of this overload and myocardial dysfunction lead to venous congestion, particularly affecting the lungs, kidneys and gastrointestinal system. Effective fluid management is therefore crucial to maintain a balance between adequate tissue perfusion and prevention of fluid overload. Fluid tolerance, defined as a patient's ability to tolerate additional volumes of solutes without adverse effects, is assessed retrospectively by clinical signs (capillary refill time, oedema, hepatojugular reflux, etc.) and ultrasound scores (VExUS score, LUS score, etc.). However, these indicators do not fully reflect the complexity of venous congestion in patients with various conditions. Assessing fluid tolerance remains a challenge in clinical practice. It requires a personalised approach and the use of dynamic tests such as passive leg raising to predict response to vascular filling. Despite their common use, there are no studies evaluating the ability of changes in congestion markers during passive leg raising to predict fluid tolerance. In conclusion, the main hypothesis is that changes in ultrasound congestion parameters (VExUS score, LUS score and others) during passive leg raising could predict a patient's subsequent tolerance to volume expander.

NCT ID: NCT06415344 Not yet recruiting - Angelman Syndrome Clinical Trials

Long-term Extension of GTX-102 in Angelman Syndrome

Start date: August 2024
Phase: Phase 3
Study type: Interventional

The primary objective of the study is to evaluate the long-term safety profile of GTX-102 in participants with Angelman Syndrome (AS)

NCT ID: NCT06415266 Not yet recruiting - Breast Cancer Clinical Trials

Assessment the sExual Quality of Life in Breast Cancer Patients Receiving oncoSexology Supportive Care on Proactive Versus On-request

VENUS
Start date: May 2024
Phase: N/A
Study type: Interventional

The study compares the quality of sexual life of breast cancer patients under two types of oncoSexology supportive care : personalized supportive care versus on-request. The aim is to improve the quality of sexual life of these patients.

NCT ID: NCT06414772 Not yet recruiting - Language Barrier Clinical Trials

Evaluation of an E-tool Designed to Facilitate Communication Between Allophone Patients and Pediatricians in Emergency Departments.

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

In France, over 21 million people visit emergency departments every year, 10% of whom speak little or no French. The language barrier is a problem for patient safety and quality of care. Ethical and financial aspects are also affected. Unnecessary tests are more frequent, hospital stays more numerous and longer. Patient's management may be inappropriate. Patients are less satisfied, understand and adhere less to cmanagement and recommendations. Some solutions are available to the emergency physician, but their contribution is limited. A professional interpreter is reliable and takes cultural aspects into account, but his or her cost is high and availability incompatible with emergency care. Translation by a close relative poses the problem of confidentiality. Telephone interpreting is available at any time, but is expensive and less satisfying than direct interaction. Computerized machine translation is economical and easy to access, but does not take into account all medical terms. It also poses a data protection problem. Phraselators translate predefined phrases with precision, but are time-consuming and unsophisticated. In addition, these aids are used during the consultation. They are therefore difficult to combine and take up care time. This care time is mainly devoted to establishing medical history essential for the diagnosis, prognosis and treatment decisions. MARTI is a digital tool for pediatric emergency room consultations. Its aim is to enable the emergency physician to start the consultation with a medical history completed autonomously by the parents during their waiting time. Its content has been developed by emergency physicians. Language and cultural barriers are overcome through the use of simple phrases and pictograms developed with linguists, language schools and Immigrant organizations. MARTI was used in a pediatric emergency department. Feedback from patients and carers indicates that it is ready to be tested in real-life conditions. This pilot study is designed to evaluate how MARTI improves communication with an allophone or a person with comprehension difficulties, according to the emergency physician in charge of the consultation.

NCT ID: NCT06413706 Not yet recruiting - Glioma Clinical Trials

A Study Comparing Abemaciclib Plus Temozolomide to Temozolomide Monotherapy in Children and Young Adults With High-grade Glioma Following Radiotherapy

Start date: June 2024
Phase: Phase 2
Study type: Interventional

The purpose of this study is to measure the benefit of adding abemaciclib to the chemotherapy, temozolomide, for newly diagnosed high-grade glioma following radiotherapy. Your participation could last approximately 11 months and possibly longer depending upon how you and your tumor respond.

NCT ID: NCT06412614 Not yet recruiting - Systemic Sclerosis Clinical Trials

Evaluation of Patients With Systemic Sclerosis Without Specific or Associated Autoantibodies

SCLERONAB
Start date: September 2, 2024
Phase:
Study type: Observational

Systemic sclerosis (SSc) is a complex systemic autoimmune disease with variable phenotype and prognosis. Autoantibodies are important diagnostic biomarkers in SSc. More than 90% of patients with SSc had anti-nuclear antibodies. Autoantibodies specific to SSc (anti-topoisomerase I antibodies, anti-centromeres, anti-RNA polymerase III, anti-Th/To, anti-fibrillarin, anti-NOR90) or associated with overlap syndromes (anti-RNA polymerase III antibodies -PM/Scl, anti-KU, anti-U1RNP, anti-TRIM21) are detected in most patients. Excluding anti-TRIM21 antibodies, autoantibodies are usually mutually exclusive and are associated with distinct phenotypes. Around 5 to 10% of patients with SSc have no autoantibodies detectable with routine biological tests. Recently, new autoantibody specificities have been described in SSc (anti-eIF2B, anti-RuvBL1/2, anti-BICD2, anti-U11/U12 RNP antibodies). "Seronegative" patients could represent new specificities of autoantibodies (unknown or not currently routinely evaluated) associated with different phenotypes of the disease. Primary objective is to compare the phenotype of patients with systemic sclerosis with or without detectable specific or associated autoantibodies. Secondary objectives are: - to determine homogeneous groups of patients with systemic sclerosis without detectable specific or associated autoantibodies - to compare the phenotype of patients with systemic sclerosis without detectable specific or associated autoantibodies according to anti-nuclear antibodies status

NCT ID: NCT06410079 Not yet recruiting - Femur Head Necrosis Clinical Trials

Difference in Return to Sports Activity After Hip Arthroplasty by THR or Resurfacing

PTH-50
Start date: June 1, 2024
Phase:
Study type: Observational [Patient Registry]

This study aims to evaluate the return to activity in younger patients under 50 years old after undergoing either total hip replacement (THR) or hip resurfacing, as performed in everyday practice. This research will be observational, meaning patients will not be randomly assigned to different treatment groups. To objectively assess participents; return to everyday, professional, and sports activities, validated questionnaires will be sent to participents in addition to routine clinical practice. The study will be prospective and comparative based on the type of prostheses used. In order to capture the current practices of surgeons performing THR in participents under 50 years old in France, the study will be conducted at multiple centers across the country. Since hip resurfacing is performed only in certain centers, approximately half of the participating centers are experienced in this technique. Participents typically resume activity between 3 and 6 months after THR. One year of post-operative follow-up allows for an accurate assessment of participents; recovery, unaffected by the surgery. Participents ; physical activity levels will be evaluated using the UCLA Activity Scale developed by surgeons to assess the activity levels of patients undergoing hip and arthroplasty.

NCT ID: NCT06409767 Not yet recruiting - Multiple Myeloma Clinical Trials

Impact of an Early Warning System on the Prognosis of Patients With Hematological Malignancies Receiving Intensive Chemotherapy With or Without Hematopoietic Cell Transplantation.

ALHERT
Start date: October 15, 2024
Phase: N/A
Study type: Interventional

Patients with hematologic malignancies requiring intensive chemotherapy are at risk for life-threatening complications. Organ failure may appear rapidly and delay in initiating life-sustaining interventions may result in increased mortality. This encourages great alertness although not all patients require close monitoring. It is therefore critical to identify which patients are the most at risk for clinical deterioration to consider increased surveillance in these patients. The benefit of early intensive care unit (ICU) admission, as soon as the first signs of organ dysfunction appear, must also be clarified. Such an intervention could increase survival of patients by close monitoring and early initiation of organ-specific interventions but could also be responsible for anxiety and increased use of ICU resources. Many teams have analyzed the impact of early warning systems (EWS) including vital signs to detect organ dysfunction early on. It has been shown that these EWS could positively impact survival in many medical fields (pre-hospital, medicine or surgery departments). A few retrospective studies have explored the impact of EWS in hematology, with overall good prediction for ICU admission and mortality. Until now, it has however not been formally demonstrated that early ICU admission, as soon as the first signs of organ dysfunction appear, could benefit patients with hematologic malignancies. A randomized controlled trial studying the impact of early intervention would clarify the role of such a strategy. In this study, the investigators will prospectively evaluate the implementation of the National Early Warning Score (NEWS), with systematic referral to the ICU in high-score patients, to improve the survival of patients receiving intensive chemotherapy in ten academic centers. This score is one of the most performant and most frequently used to predict organ failure. Its calculation only requires vital signs such as respiratory rate, peripheral oxygen saturation, need for oxygen therapy, body temperature, arterial pressure, heart rate, and level of consciousness. The investigators will therefore study the impact of ICU admission in patients with high NEWS in a randomized, controlled trial. A cluster randomization is planned in which the centers will be randomized between usual care (control group) and interventional care with transfer to the ICU in the event of a NEWS score ≥7 (interventional group). Each parameter used to calculate the NEWS will be collected at least three times a day by the attending nurse.

NCT ID: NCT06408701 Not yet recruiting - Eye Abnormalities Clinical Trials

Modeling Ocular Developmental Diseases From 3D Cultures of Optic Vesicle Organoids Derived From hiPSCs of Patients With Ocular Malformations

OrganoEye
Start date: May 2, 2024
Phase:
Study type: Observational

Ocular morphogenesis is a complex process starting as early as the 4th week of embryonic life, involving interactions between varioustissues of different origin and conserved genes. Anomalies in ocular development , often of genetic origin, pose diagnostic and therapeutic challenges. Animal models are limited, so human-induced pluripotent stem cell (hiPSC)-derived optic vesicle containing brain organoids (OVBOs) offer a promising alternative. These pathological OVBOs, created from patients' cells with ocular malformations, allow for the study of underlying molecular mechanisms and testing of therapies.

NCT ID: NCT06408428 Not yet recruiting - Epilepsy Clinical Trials

Glioma Intraoperative MicroElectroCorticoGraphy

MicroECoGG
Start date: September 2024
Phase: N/A
Study type: Interventional

The goal of this clinical trial is to validate the safety and to assess the quality of the signals provided by newly developed micro ElectroCorticoGraphy electrodes, provided by the company Panaxium, based on conductive polymers (PEDOT:PSS) in patients suffering of gliomas during resection surgery performed in awake condition. The main questions it aims to answer are: - Safety of PEDOT:PSS microECoGs by assessing the rate of serious adverse events associated with their use during glioma surgery. - Quality of PEDOT:PSS microECoGs recordings, as compared with recordings with traditional macroelectrodes, assessed by signal-to-noise ratio, impedance, ability to detect ripples (100-250 Hz) and fast ripples (250-600 Hz), ability to record epileptic activity (spikes and equivalent) either spontaneously or following direct electrical stimulation (afterdischarges). - Practicality of microelectrodes use as perceived by neurosurgeons. - Exploratory objectives: ability to record multi-unit activity, correlation between microECoG activity and tumor infiltration - local oncometabolite concentrations, determination of epileptic seizure rate during electrode use. Participants will be recorded during awake glioma surgery by the newly developed micro ElectroCorticoGraphy electrodes and by routine macroelectrodes, as standard of care during both mapping of cortical activities and electrical stimulations used to assess the functional mapping mandatory for tailored tumor resection.