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NCT ID: NCT06044922 Not yet recruiting - Cardiac Arrest Clinical Trials

Heart Rate Variability in Early Prediction of a Noxic Brain Injury After Cardiac Arrest

HEAVENwARd
Start date: April 15, 2024
Phase:
Study type: Observational

Despite advances in post-resuscitation care of patients with cardiac arrest (CA), the majority of survivors who are treated after restoration of spontaneous circulation (ROSC) will have sequelae of hypoxic-ischemic brain injury ranging from mild cognitive impairment to a vegetative state. Early prognostication in comatose patients after ROSC remains challenging. Recent recommendations suggest carrying out clinical and paraclinical tests during the first 72 h after ROSC, to predict a poor neurological outcome with a specificity greater than 95% (no pupillary and corneal reflexes, bilaterally absent N20 somatosensory evoked potential wave, status myoclonus, highly malignant electroencephalography including suppressed background ± periodic discharges or burst-suppression, neuron-specific enolase (NSE) > 60 µg/L, a diffuse and extensive anoxic injury on brain CT/MRI), but with a low sensitivity due to frequent confounding factors. The heart rate variability (HRV) is a simple and non-invasive technique for assessing the autonomic nervous system function. In patients with a recent myocardial infarction, reduced HRV is associated with an increased risk for malignant arrhythmias or death. In neurology, reduced HRV is associated with a poor outcome in severe brain injury patients and allows to predict early neurological deterioration and recurrent ischemic stroke after acute ischemic stroke. A reduced HRV could be a sensitive, specific and early indicator of diffuse anoxic brain injury after CA. This multicenter prospective cohort study assesses the added value of early HRV (within 24h of ICU admission) for neuroprognostication after cardiac arrest.

NCT ID: NCT06042075 Not yet recruiting - Feelings Clinical Trials

Representation of Congenital Birthmarks

ReCONNAISSANCE
Start date: October 2023
Phase:
Study type: Observational

This descriptive cross-sectional single center study will be conducted at Angers Maternity Unit. It pertains to the ways in which healthcare professionals represent congenital birthmarks found in newborns. It is our assumption that health professionals may have a tendency to engage in inappropriate behavior when dealing with congenital birthmarks due to lack of knowledge. We make the presumption that insufficient knowledge causes difficulties in managing these birthmarks. Data as to representation of birthmarks in newborns by health professionals will be collected using a semi-quantitative questionnaire. This study constitutes preliminary research work, with a view to creating a professional development plan if necessary.

NCT ID: NCT06041841 Not yet recruiting - Clinical trials for PCSK1 Deficiency Obesity

A Phase 2 Study to Assess Efficacy and Safety of LB54640 in Patients With Genetic Obesity

Start date: December 2023
Phase: Phase 2
Study type: Interventional

The purpose of the study was to assess the efficacy of LB54640 in participants with rare genetic disorders of obesity

NCT ID: NCT06039215 Not yet recruiting - Clinical trials for Acute Respiratory Distress Syndrome

Paramedical Protocol for Ventilation in Acute Respiratory Distress Syndrome

PARAVENT
Start date: October 1, 2023
Phase: N/A
Study type: Interventional

Acute respiratory distress syndrome (ARDS) is a frequent pathology in intensive care (around 10% of patients admitted to intensive care and almost a quarter of patients on mechanical ventilation) and a serious one, with a hospital mortality rate of 40%. The main measures that have an effect on mortality in ARDS involve adjustments to the ventilator, known as protective ventilation. In the most severe patients, adjuvant measures such as prone positioning and the use of curarisation in the initial phase of the disease can improve survival. All these measures have been included in the latest national and international recommendations. However, a vast observational study carried out in 50 countries revealed low compliance with these recommendations. More than a third of patients did not receive protective ventilation, and the majority did not receive prone positioning when this was indicated. During weaning from artificial ventilation, it has been widely demonstrated that replacing clinician judgement with the implementation of paramedical care protocols improved weaning and significantly reduced the duration of artificial ventilation. Therefore, investigators hypothesize that the implementation of a paramedical care protocol for ventilation in the acute phase of ARDS improves compliance with recommendations and thus reduces mortality and the duration of artificial ventilation. However, implementation of such a protocol requires operational training for all the nurses in the participating departments. Simulation appears to be the training method of choice, as it is a teaching technique that enables technical and non-technical skills to be passed on with good retention of what has been learnt, as well as assessing what has been learnt. To make it possible to train several dozen nurses within a tight timescale, a partially dematerialized simulation model incorporating innovative e-learning tools will be developed.

NCT ID: NCT06037421 Not yet recruiting - Clinical trials for Bacteria in Breast Milk

Metagenomic Analysis of Bacterial Microbiota in Breast Milk

MIC-LAMA2
Start date: September 1, 2024
Phase:
Study type: Observational

The aim of this study is to determine the extent to which bacteria in the breast milk microbiota represent an infectious risk for premature infants, by investigating whether they possess virulence genes, and if so, whether these are expressed or repressed.

NCT ID: NCT06035991 Not yet recruiting - Clinical trials for Heart Transplantation

First Clinical Evaluation of Heart Transplantation With Grafts Preserved Using an Ex-vivo Extended Perfusion System

PEGASE
Start date: September 2023
Phase: N/A
Study type: Interventional

The main objective of PEGASE is to validate the recovery of a satisfactory cardiac function of a transplanted heart after a prolonged period of preservation by an ex-vivo perfusion device. This recovery of cardiac function will have to happen within 15 days after transplantation.

NCT ID: NCT06034938 Not yet recruiting - Hiv Clinical Trials

DOR/TDF/3TC Switch With M184V/I in People With Controlled HIV (Drive Off-Road)

DOR
Start date: December 1, 2023
Phase: Phase 2
Study type: Interventional

The goal of this pilot, phase 2, single-arm, clinical trial is to assess the antiretroviral combination Doravirine (DOR)/Lamivudine (3TC)/Tenofovir Disproxyl Fumarate (TDF) in participants with suppressed HIV who previously developed M184V/I mutation that confers resistance to 3TC. The main question it aims to answer is to explore the rate of HIV suppression 24 weeks after the switch to DOR/3TC/TDF. The study follow-up will continue until 48 weeks. Other endpoints will be metabolic changes, weight changes, modification in the HIV-DNA mutations overtime. Eligible participants will switch from their prior regimen to DOR/3TC/TDF with careful HIV-RNA monitoring.

NCT ID: NCT06033339 Not yet recruiting - Clinical trials for Familial Mediterranean Fever

Assessment of microRNAs Role in Familial Mediterranean Fever FMF Pathophysiology

miRinFMF
Start date: October 2, 2023
Phase: N/A
Study type: Interventional

Familial Mediterranean Fever (FMF) genetic diagnosis is well established for homozygous patients. On the other hand, although heterozygous individuals are theoretically healthy carriers, 1/3 of them will develop clinical symptoms of FMF and could benefit from prophylactic treatment. This suggests that the disorder expression mechanisms are not fully elucidated to date. The preliminary results obtained at the Institute for Regenerative Medicine and Biotherapy (IRMB) suggest the involvement of an epigenetic mechanism in FMF pathogenesis, and our laboratory has strong arguments as to the involvement of microRNAs (in particular miR-326) which are negative regulators of gene expression. This study is exploratory and aims to validate the role of miRNAs in the clinical expression of FMF in patients, thus to explore the epigenetic mechanisms that may explain the variability of expression of this disorder.

NCT ID: NCT06029166 Not yet recruiting - Atrial Fibrillation Clinical Trials

Subcutaneous Cardiac Monitoring of Patients With BTK Inhibitors

IRAF-ISCM
Start date: October 1, 2023
Phase: N/A
Study type: Interventional

The goal of this clinical trial is to screen all types of electrocardiographic changes and rhythm disorders in adult patients with a hematologic malignancy requiring a treatment by Bruton's tyrosine kinase (BTK) inhibitor (ibrutinib, acalabrutinib, zanubrutinib) using an insertable subcutaneous cardiac monitor (ISCM) and occurring from inclusion and within 12 months. This study consists of the implantation of an ISCM at inclusion and before BTK inhibitor initiation. Then patients will have medical visits every 3 months (+/- 7 days) during 12 months and a continuous cardiac telemonitoring using the ISCM.

NCT ID: NCT06027697 Not yet recruiting - Knee Osteoarthritis Clinical Trials

Prospective Evaluation of Subchondroplasty in Advanced Knee Osteoarthritis.

Start date: December 2023
Phase:
Study type: Observational

The goal of this observational study is to evaluate the technique of subchondroplasty in patients with advanced knee osteoarthritis. The main question it aims to answer is: • Does the subchondroplasty technique with the administration of AccuFill Porous Bone Substitute Material (BSM) is effective in the relief of mechanical pain in patient with knee osteoarthritis ? Participants will go under a minimally invasive surgery procedure (subchondroplasty) and fulfil 3 validated questionnaires to assess pain, functional impairments and subjective improvement. This study will be conducted for 4 years.