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NCT ID: NCT06344442 Not yet recruiting - Clinical trials for Acute Kidney Injury Post Liver Transplantation

Low-dose Arginine-vasopressin Supplementation on Post-transplant Acute Kidney Injury After Liver Transplantation (AVENIR Trial)

Start date: June 20, 2024
Phase: Phase 3
Study type: Interventional

Liver transplantation (LT) is a high-risk surgery for hemodynamic instability and haemorrhagic shock with a high-risk of acute kidney injury (AKI). Indeed, the incidence of post-transplant AKI exceeds 50% in some series with 15% of patients requiring renal replacement therapy. Acute kidney injury after LT is a predisposing factor for chronic renal failure which is independently associated with higher morbidity and mortality. Arginine vasopressin (AVP), an essential stress hormone released in response to hypotension, binds to AVPR1a to promote vasoconstriction. Furthermore, it may have nephroprotective effects with a preferential vasoconstriction of the post-glomerular arteriole resulting in increased glomerular filtration The hypothesis of the present work is that low-dose arginine-vasopressin supplementation reduce posttransplant AKI in liver transplantation.

NCT ID: NCT06341543 Not yet recruiting - Clinical trials for Kidney Transplantation

Quantiferon CMV to Identify Treatment Need For Asymptomatic CMV Infection After Solid Organ Transplant (QUANTIFOT)

QUANTIFOT
Start date: April 25, 2024
Phase: N/A
Study type: Interventional

Context Cytomegalovirus (CMV) infection is a frequent and potentially severe event in solid organ transplant (SOT) recipients. Most of available treatment display adverse effects that limit their use. Therefore, in case of an infection, it is of primary importance to identify the patients at high risk of severe infection and/or disease, and who ill benefit the most from antiviral therapy. As CMV infection is mainly controlled by cellular immunity, measuring specific anti-CMV T lymphocyte immunity could be an interesting tool for identifying these at-risk individuals. One of these tests is the QuantiFERON-CMV (QF-CMV) assay (QuiagenTM, Courtabœuf, France). Aim of the study The aim of the study is to determine the extent to which the QF-CMV can be use to identify, among SOT recipients with a CMV viremia, those that may not need antiviral therapy. Methods Participation to the study will be proposed to SOT recipients with an asymptomatic CMV infection with a blood viral load between 1,000 and 15,000 IU/mL. The QF-CMV will be performed in included participants, and the result will be given or not to the clinician in charge (according to the attributed group through randomisation). - In the group without result communication, the clinician in charge will determine whether a treatment is needed according to the guidelines and the local practices. - in the group with result communication, the clinician in charge will be advised not to introduce antiviral therapy if the result is positive, and to determine whether a treatment is needed according to the guidelines and the local practices if the result is positive. In the following weeks, the viral load will be monitored, along with creatininemia, cell blood count, and kalemia (to detect antiviral adverse effect). The participants will be sampled: - 5 to 12 days after QF-CMV sampling (V2) ; - 7 to 14 days days after V2 (V3 - between D12 and D26) ; - 7 to 14 days days after V3 (V4 - between D19 and D40) . Endpoints The primary endpoint is the rate of uncontrolled infection 5 to 12 days after QF-CMV sampling, defined as follows: - Blood CMV viral load >10,000 IU/mL [4 log]; - And/or increase in blood viral load ≥0.5 log IU/mL with CV otherwise >5000 IU/mL; - And/or the onset of CMV disease. The secondary endpoint is the is the occurrence antiviral adverse effects (hematoxicity or nephrotoxicity).

NCT ID: NCT06340269 Not yet recruiting - Clinical trials for Multiple Organ Failure

Feasibility Pilot Study to Evaluate the Safety and Performance of the MEX-CD1 Medical Device in ACLF

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

The goal of this clinical trial is to test the MEX-CD1 hemodialysis medical device in patients suffering from ACLF. The main questions it aims to answer are: - Is the device safe when used according to the instructions for use? - Does the device work as expected by removing the excess of free copper from the blood? Patients will receive 3 MEX-CD1 Slow Low volume CVVHD within 1 week.

NCT ID: NCT06338345 Not yet recruiting - Cardiac Arrest Clinical Trials

Pharmacokinetics and Modelling of Beta-Lactam in ECMO-VA Patients

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

The use of antibiotic therapy is common in intensive care units and primarily involves beta-lactams. Its optimal implementation is made difficult by the pharmacokinetic changes inherent in critically ill patients. Despite the current recommendations from the French Society of Anesthesiology and Intensive Care (SFAR) and the French Society of Pharmacology and Therapeutics (SFPT), there are no recommendations on prescription modalities for patients under veno-arterial extracorporeal membrane oxygenation (VA-ECMO). The use of antibiotic therapy is common in VA-ECMO patients and their pharmacokinetic variability factors are then exacerbated. We aim to conduct a prospective, multicenter, interventional study designed to identify predictive factors for failure to achieve therapeutic target circulating concentrations of beta-lactams in patients under VA-ECMO treated with one of the studied beta-lactams

NCT ID: NCT06337630 Not yet recruiting - Solid Tumor Clinical Trials

A Study on Tuvusertib (Oral ATR Inhibitor) in Combination With PLX038 (Topo1 Inhibitor) in Patients With Advanced Solid Tumors

POP-ART
Start date: June 15, 2024
Phase: Phase 1
Study type: Interventional

Phase I with a dose finding cohort, followed by expansion cohorts in pre-specified tumor types.

NCT ID: NCT06337487 Not yet recruiting - Oncology Clinical Trials

Quality of Life Assessment for Early Identification of Supportive Care Needs in Oncology Patients

SOS-DETEQT
Start date: March 2024
Phase: N/A
Study type: Interventional

The aim of this study is to evaluate the value of the nurse's use of the Quality of Life (QoL) scores of the European Organisation for Research and Treatment of Cancer [EORTC] Quality of Life Questionnaire [QLQ] C30 as an aid in identifying the needs for supportive oncological care at the start of care, in patients followed up for locally advanced or metastatic cancer starting systemic antineoplastic treatment. The main questions it aims to answer are as follows: - Comparison of the personalised oncology support care plans proposed by the nurse before and after the QoL results were obtained - The nurse's assessment of the relevance of the information provided by the QOL scores. During the Care Support Stage (CSS), the nurse will assess the patient's situation during the interview and will fill in directly on an electronic form the Oncological Support Care proposed to the patient, making up the Personalised Pre-QoL Oncological Support Care Plan (PPSOS pre-QoL). The nurse will then give the patient the tablet to fill in the QoL questionnaire. She will then look at the results of the QoL questionnaire and the alerts in the event of deterioration, and will reassess the PPSOS using a new computerised PPSOS post-QoL form. The nurse will assess the relevance of the information provided by the QoL scores concerning the urgency of care, the need to go into certain subjects in greater depth, the identification of problems not addressed before or the discussion of sensitive subjects not addressed before. The nurse will give the patient the tablet to fill in a satisfaction questionnaire. In an attempt to control the biases inherent in an assessment carried out by a single healthcare professional, the clinical records of the patients included will be presented to a group of professionals who will also propose a PPSOS, known as Experts. The group will be made up of a nurse, a medical oncologist and at least two healthcare professionals and professionals in a similar field (dietician, psychologist, APA teacher, social worker, etc.). This group will analyse all the patient files included in the two study centres at dedicated meetings. In order to characterise patient care following the CSS, the oncological support care performed, unscheduled hospitalisations, emergency room visits and calls to the on-call medical team will be collected for the two months following the CSS.

NCT ID: NCT06337136 Not yet recruiting - Clinical trials for Neonatal Motor Pattern

neonAtal motoR paTtErn autoMatIc analySis

AIMOTHERNeo
Start date: June 2024
Phase:
Study type: Observational

This project consists in developing a computerized clinical assessment system for newborns that takes into account the four major criteria of the various clinical scales: facial mimicry, cry, posture and movement. Classification of motor patterns according to gestational age at birth The aim of this work is the automated identification of pathological motor patterns related to anoxo-ischemic encephalopathy/brachial plexus paralysis/early neonatal bacterial infection/stroke/etc ...

NCT ID: NCT06336733 Not yet recruiting - FMF Clinical Trials

Randomized Controlled Trial in Patients on Long-term Colchicine With Colchicine-resistant Familial Mediterranean Fever (FMF) to Evaluate the Efficacy of On-demand Anakinra Treatment for Painful Attacks in Patients Who Refuse Continuous Daily Therapy

KIN-ATTACK-FMF
Start date: March 2024
Phase: Phase 3
Study type: Interventional

To evaluate the efficacy on clinical symptoms in case of FMF attack among FMF patients resistant to Colchicine of - on demand anakinra treatment (100 mg/d from the prodromal phase of the attack until 24 hours of remission (during 7 days maximum) associated with daily colchicine. - compared to analgesic associated with daily colchicine in patients refusing continuous anti-IL-1 treatment.

NCT ID: NCT06336577 Not yet recruiting - Down Syndrome Clinical Trials

Infectious and Non-infectious Lower Respiratory Diseases in Children With Down Syndrome Followed in Pediatric Pulmonology Consultations in Ile-de-France

ARBT21
Start date: April 1, 2024
Phase:
Study type: Observational

The purpose of this study is to describe infectious and non-infectious lower respiratory tract diseases in children with Down syndrome followed in pediatric pulmonology consultations in Ile de France.

NCT ID: NCT06336473 Not yet recruiting - Clinical trials for Ehlers-Danlos Syndrome

Evaluation of the Effects of Cross Linking on the Biomechanical Characteristics of Skin Samples From Patients With Classic or Hypermobile Ehlers-Danlos Syndrome

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

The main aim of this study is to evaluate the effect of cross linking on the elasticity of skin samples from patients with non-vascular Ehlers-Danlos Syndrome (hEDS or cEDS).