Lloret De Mar (girona), Spain
Study of the Efficacy of Moderate Sedation With Intra-NAsal Dexmedetomidine Monitored by EEG MOnitoring
For some children, brain MRI is a particularly important examination for etiological assessment or for monitoring the progress of neurological diseases. It can sometimes be complicated to perform, due to the age and/or pathology of the child concerned. Impossibility, postponement or the need for a general anaesthetic are constraints that should be avoided as far as possible. Procedural sedation with dexmedetomidine (DEX) can be administered intra-nasally. This technique offers good results and safety of use. Nevertheless, the failure rate is 20% to 30%, and may depend on the dosage of DEX used (indicated doses vary from 2 to 4 μg/kg). This study aims to evaluate whether a sedation score obtained by a per-procedural electroencephalogram (EEG), the PSI score, could identify patients for whom a 2 μg/kg dose of DEX would not be sufficient for the successful performance of cerebral NMRI, and who could therefore benefit from a higher dosage of DEX (4 μg/kg).
Phase
N/ASpan
53 weeksSponsor
Centre Hospitalier Régional Metz-ThionvilleMetz
Recruiting
Prospective Cohort Study of Protected Children
A significant number of children are abused or neglected every year. This exposure is associated with short- and long-term consequences for their mental and somatic health, making child abuse a real challenge for society, both on an individual level, in terms of equal opportunities, and on a collective level, from a public health and economic point of view. In France, 308,000 minors benefit from at least one child protection service or measure. There are few data available on the health status of this population and its evolution over time, but they all point to the poor health status of children when first placed into care, with a particularly high prevalence of mental disorders, a low proportion of children benefiting from an initial health check-up, and poor quality of medical follow-up once in care. In this context, interventions are needed to address early and comprehensively the many needs of children put into care, both in the short and long term. In particular, early detection and reduced delays in the initiation of appropriate medical care appear to have positive long-term effects, reducing medico-social needs. As such, the PEGASE program, which is funded by the French government under Article 51, was developed to ensure adequate medical follow-up - both somatic and psychiatric - for children taken into care by child protective services (CPS). Children in the PEGASE program are monitored with regular, standardized check-ups, with an initial standardized check-up when the child enters the care facility followed by 20 regular assessments at fixed ages up to the age of 7. Most of these assessments are reinforced in PEGASE by the systematic use of standardized scales to identify potential disorders and developmental delays, so that the necessary care can be implemented at an early stage. An evaluation of the program's effectiveness and efficiency is needed to inform public decision-making on the appropriateness of extending it to all children in care. As there is no control group in the PEGASE program, this requires the creation of a control cohort of children followed by CPS but not benefiting from the PEGASE program. This is the ESPER cohort (Prospective cohort study of protected children), which will enable us to carry out a comparative evaluation of the PEGASE program, as well as to provide information on the health of children taken into care by the CPS at the time of their placement, and on its evolution over time, data which are rare in France. The primary objective is to evaluate the effectiveness of the PEGASE program on the evolution of the mental health of children followed by the CPS after 2 years of follow-up. The secondary objectives are: - To evaluate the effectiveness of the PEGASE program on the evolution of children followed by the CPS after 1 and 2 years of follow-up, in terms of: mental health, physical health, development (communication, gross motor skills and fine motor skills), care pathway, and school integration, - To evaluate the cost-effectiveness of the PEGASE program after 2 years of follow-up, and its budgetary impact in the case of generalization, - To describe the health of children when they are put into care. An ancillary study is also planned to compare the health of children followed by CPS to the health of children in the general population. This is a comparative study with an external control group and propensity score matching, calculated from a multivariate logistic regression model that will include a priori: corrected age at inclusion, gender, gestational age, ASQ-SE and ASQ-3 scores at inclusion, reason for placement, current protective measure, and social situation of both parents. The PEGASE program is already the subject of a separate protocol describing recruitment procedures and follow-up of children benefiting from the program. The population included in the ESPER study are children taken into care by CPS in 8 volunteer departments not participating in the PEGASE program. They must be aged less than 42 months (i.e. 3 and a half years), arriving for the first time in a participating center, and the holders of parental authority must not object to participation in the study. The children included the ESPER cohort will be followed as usual by the participating center during the two years of follow-up. Additional data collection by questionnaire will be added to the usual care at inclusion, and then at 1 and 2 years of follow-up either in person or by telephone by the study's local coordinators (if the child is no longer in the facility at the time of collection). At the inclusion visit, parents or legal guardians will be informed of the study, and their non-opposition will be sought. All socio-demographic, health and school data will be collected by the local coordinators. The ASQ-SE and ASQ-3 questionnaires will be completed, as well as antenatal and pre-placement health data. The data will then be entered into the eCRF by the local coordinators. At one year of follow-up, the local coordinators will collect health data (from the health records) and school data. If the child is no longer in the facility, data will be collected by telephone from the child's care takers, or from the parents (or holders of parental authority) if the child lives with them. The ASQ-SE and ASQ-3 questionnaires will be completed by the same person. The local coordinators will then enter the data into the tool. The 2-year follow-up visit will be identical to the 1-year visit. It is planned to include 400 children in the ESPER cohort. The inclusion period is 12 months, and the duration of each child's participation in the study is 24 months.
Phase
N/ASpan
209 weeksSponsor
Assistance Publique - Hôpitaux de ParisMetz
Recruiting
Prognosis of Posterior Lamellar Keratoplasty, an Observational Cohort Study
Phase
N/ASpan
814 weeksSponsor
Centre Hospitalier Régional Metz-ThionvilleMetz
Recruiting
Epidemiological Study of a Prospective Cohort of Patients Aged 60 and Over Managed for Acute Myeloid Leukemia (AML) and Receiving Intensive Induction Therapy
Phase
N/ASpan
835 weeksSponsor
French Innovative Leukemia OrganisationMetz
Recruiting
Description of Patient Adherence to Heart Failure Remote Monitoring and Its Determinants
In 2022, the Caisse Primaire d'Assurance Maladie indicated that 'more than 1.5 million people suffer from heart failure, particularly the over-60s. Heart failure has a major impact on the quality of life of individuals and their families. It is the cause of 200,000 hospitalisations a year. With an ageing population, the incidence of heart failure is set to increase by 25% every four years over the next few years'. In its WHITE PAPER, the Conseil National Professionnel Cardio Vasculaire recommended the day-to-day use of digital tools to monitor patients in the face of delays in consultations in towns and cities. According to the studies carried out, these 'delays (...) are such that they do not prevent 47.4% of patients from being admitted to hospital more than 15 days after the onset of the first symptoms. For a third of patients, this delay rises to more than 2 months'. According to Brandon et al, in 2009 remote monitoring of patients with the implementation of call by an ABI reduces CI-related readmissions and this helps to improve patients' quality of life.However, they noted that this required 'further exploration of the role of the API in helping patients with CI achieve desired outcomes.'A 2022 study based on a multicentre randomised controlled trial showed that remote monitoring after hospitalisation improved survival in heart failure patients. Other chronic pathologies are also monitored remotely, such as inflammatory arthritis.A prospective cohort study of 220 patients conducted by J. WIEGEL, published in 2022, looked at the profile of patients who did or did not adhere to remote monitoring of their condition.It was found that women discontinued this type of treatment more quickly. In conclusion, he wondered about the 'reasons why patients do not adhere to telemonitoring, as well as the reasons why they do'. He concluded by saying that these reasons 'must be studied in order to improve the adaptation of telemonitoring'.
Phase
N/ASpan
53 weeksSponsor
Centre Hospitalier Régional Metz-ThionvilleMetz
Recruiting
Regorafenib in Combination With Multimodal Metronomic Chemotherapy for Chemo-resistant Metastatic Colorectal Cancers
Phase
2Span
220 weeksSponsor
Centre Hospitalier Universitaire de BesanconMetz
Recruiting
Evaluation of the Impact of Ambulatory Epidural on Maternal Satisfaction During Delivery and Postpartum
This is a multi-centre prospective observational analytical before/after-type study. Practice changes are planned in concerned departments, in particular regarding usual patient care. This observational study aims to quantify the impact of practice changes on patient experience using a Childbirth Assessment Questionnaire (QEVA). During the "before" period, patients will receive a conventional epidural while the others, during the "after" period, will receive an ambulatory epidural. The women involved into this study must fill the QEVA form 2 days after giving birth (at the maternity) then 4 weeks after giving birth in order to get a feedback related to postpartum feelings (phone call).
Phase
N/ASpan
57 weeksSponsor
Centre Hospitalier Régional Metz-ThionvilleMetz
Recruiting
A French Multicenter Observational Retrospective Study of Rare Primary Liver Cancers
The aim is to describ rare primary hepatic cancers clinical, histological and radiological features, to obtain a biological tumor and blood collection, and to evaluate the efficacy of treatments received in clinical practice in order to determine optimal therapeutic sequences.
Phase
N/ASpan
362 weeksSponsor
Federation Francophone de Cancerologie DigestiveMetz
Recruiting
Differential Pressure Distribution Orthosis by 3D Printing Process in the Treatment of Post-burn Hypertrophic Scarring
Phase
N/ASpan
53 weeksSponsor
Centre Hospitalier Régional Metz-ThionvilleMetz
Recruiting
Study of the Value of Maternal-fetal Transfers and Their Complexity of Their Implementation
Over the past year, an audit carried out on the Mercy maternity unit, covering 130 transfers to the Nancy regional maternity hospital, showed that patients transferred for threat of premature delivery (MAP) with a cervix > 15 mm do not give birth at the receiving maternity unit, but return home after 48 hours' hospitalization. When maternal-fetal transfer (MFT) is requested, numerous calls are made to private ambulance services, and in the end, many emergency rapid response units (SMUR) are called out, requiring a major human, logistical and time investment for a questionable benefit to the patient. Tensions in terms of logistics (lack of ambulance, SMUR) and human resources (lack of personnel) can, conversely, compromise good care of the parturient.
Phase
N/ASpan
53 weeksSponsor
Centre Hospitalier Régional Metz-ThionvilleMetz
Recruiting