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NCT ID: NCT06052878 Completed - Clinical trials for Neurodevelopmental Disorders

Neurodevelopmental Outcome After Prenatal Anesthesia

Start date: October 9, 2023
Phase:
Study type: Observational [Patient Registry]

In 2016, the US Food and Drug Administration raised concerns about the potential negative effects of anesthesia exposure on neurodevelopment in children during pregnancy or before the age of three. The impact of exposure to anesthetic agents on neurodevelopmental outcome however remains debated: clinical studies on the subject do not allow for unequivocal conclusions to be drawn, given their methodological heterogeneity and the numerous confounding environmental factors. To this date, only two studies have focused on the potential neurodevelopmental effects of general anesthesia during the prenatal period, even though general anesthesia for non-obstetric surgery during pregnancy affects up to 3% of pregnant women. This observational ambidirectional study would be the first to investigate the potential neurodevelopmental effects of prenatal exposure to anesthesia, whether general or regional, for surgery during pregnancy. It would thus differentiate between the contribution of surgical stress and that of anesthetic agents in any observed modifications. The aim of the study is: Are there any subtle modifications of executive functions associated with prenatal exposure to anesthesia during non-obstetric surgery during pregnancy? To investigate this, parents of the participating children will be asked to complete a standardized parental telephone questionnaire from the "Behaviour Rating Inventory of Executive Function" (BRIEF). This parental questionnaire allows for evaluating children's behaviors related to executive functions. Researchers will compare the score derived from the "BRIEF" parental questionnaire (BRIEF score) between three groups of children aged from 5 to 12 years old, born between 2011 and 2018 at Caen University Hospital: - The " General anesthesia " group: children whose mothers underwent general anesthesia for non-obstetric surgery during pregnancy (N: 62). - The " Locoregional anesthesia " group: children whose mothers underwent regional anesthesia for non-obstetric surgery during pregnancy (N: 31). - The " Control " group: children whose mothers did not undergo any surgical intervention during pregnancy (N: 62). The first aim of our study is to investigate the presence of a significant difference in the BRIEF score between the three groups. The seconds aims are to assess the cognitive functioning of patients in their daily lives (school, parental home, and extracurricular activities).

NCT ID: NCT06047847 Completed - NAFLD Clinical Trials

Determination of Biological Activity of Enriched Serum Following TOTUM-448 Consumption

CnC-TOTUM448
Start date: September 27, 2023
Phase: N/A
Study type: Interventional

Dietary intakes of saturated fatty acids remain well above nutritional recommendations for most European countries. This may progressively lead to a pro-inflammatory context and the alteration of lipid metabolism in the liver. The hypothesis of this study is that TOTUM-448 promotes the normal function of hepatocytes in a mild inflammatory context. To determine the cellular and molecular effects of TOTUM-448, circulating bioactive molecules after TOTUM-448 intake will be collected and then studied in human hepatocytes using an innovative ex vivo clinical approach developed by Clinic'n'Cell.

NCT ID: NCT06047145 Completed - Skin Ageing Clinical Trials

Evaluation of Soy Isoflavones on Skin Ageing Parameters

ISOSKIN
Start date: October 27, 2023
Phase: N/A
Study type: Interventional

This double-blind, placebo-controlled, randomised pilot trial aims to assess the effect of oral soy isoflavone consumption on skin ageing parameters in post-menopausal women.

NCT ID: NCT06046534 Completed - Clinical trials for Systemic Lupus Erythematosus

Retrospective Medical Chart Review Study to Describe the Experience of SLE Patients Treated With Anifrolumab in the Early Access Programs.

ERYTHRO
Start date: October 27, 2023
Phase:
Study type: Observational

The ERYTHRO study is a retrospective medical chart review study of patients in the AMANA and ATUc Early Access Programs (EAPs) across a number of countries, to assess anifrolumab usage and patient experience in treating SLE in a real-world setting. Since patient safety data are already collected and reported according to regulatory requirements through EAPs, this study will not collect safety data.

NCT ID: NCT06046339 Completed - Clinical trials for Out-of-Hospital Cardiac Arrest

Left Ventricular Ejection Fraction in Cardiac Arrest Survivors Treated With Extracorporeal Cardiopulmonary Resuscitation

FEVGECMO
Start date: April 24, 2024
Phase:
Study type: Observational

Extra-hospital cardiac arrest is a major public health problem, with approximately 46,000 cases per year. Nearly 71% of the patients for whom resuscitation was initiated did not present a return of spontaneous circulation on scene and only 29% were transported alive to the hospital. In this context, extracorporeal cardiopulmonary resuscitation (ECPR) by veno-arterial extracorporeal membrane oxygenation has been developed as a second line of treatment according to the latest international guidelines. The selection of eligible patients as well as the timing of initiation of ECPR has long been controversial, but expert recommendations have recently been published. After an out-of-hospital cardiac arrest of cardiological cause, an early ventricular dysfunction has been previously described, more particularly in hemodynamically unstable patients. This dysfunction was associated with greater early in-hospital mortality. There are few data on the medium-term course of left ventricular dysfunction and the largest study addressing this question showed that the severity of left ventricular involvement was associated with greater long-term morbidity and mortality. However, it also found that left ventricular ejection fraction was partially reversible in 29% of the study population. It seems so far, the medium-term evolution of left heart dysfunction had not been described in the context of refractory extra-hospital cardiac arrest treated by ECPR. However, these patients are particularly severe, hemodynamically unstable and potentially at risk of developing long-term sequelae.

NCT ID: NCT06046144 Completed - Melanoma Clinical Trials

Comparison of 3 in Vivo Microscopic Imaging Techniques for the Diagnosis of Pigmented Tumors

Micro3
Start date: November 2, 2022
Phase:
Study type: Observational

Reflectance confocal microscopy (RCM) is the reference in vivo imaging technique for identifying malignant melanocytic tumors prior to surgical excision. However, it is not widely used due to its high cost and highly technical and time-consuming nature. In addition to RCM, we currently use 2 less expensive dermatoscopes that also allow in vivo diagnosis: super-high magnification dermoscopy (D400) and Fluorescence-Advanced videodermatoscopy (FAV).

NCT ID: NCT06044532 Completed - Diabetes Clinical Trials

SKAMo-1: Characterization of the Upper Layers of Skin

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

Diabetes is a frequent disease characterized by chronic hyperglycemia, and its prevalence is increasing worldwide. Historically, patients with diabetes were required to monitor capillary blood glucose concentration up to several times a day through fingertip sampling. Recently marketed devices now allow measurements of interstitial fluid blood glucose continuously, thus limiting pain associated with sampling. However, they are still invasive and have to be changed every 14 days. Therefore, to optimize continuous glycemia monitoring while avoiding pain, discomfort, and the risk of infection, non-invasive methods are needed. Among the different strategies being developed, optical wearable sensors with specific signal processing are a promising option. The sensors detecting this optical signal will be included in a device. Yet, wearing a device may slightly modify several properties of the skin, such as its humidity and thermal regulation, and subsequently have an impact on the measured optical signal. Therefore, it is important to better understand how a device affects these characteristics to include these parameters in the future device algorithms.

NCT ID: NCT06041737 Completed - Renal Failure Clinical Trials

Determination of a Profile of Patients With Renal Failure to be Supported as a Priority in the Care Pathway in Order to Avoid Emergency Hospitalizations.

DETERPROFIPA
Start date: October 9, 2023
Phase:
Study type: Observational

The purpose of this study is to map the population of stage 4 and 5 kidney failure patients followed in consultation by the CHSF nephrology team and to determine the factors associated with recurrent hospitalizations.

NCT ID: NCT06039124 Completed - HHT Clinical Trials

Subsequent Bevacizumab Treatment in Patients With HHT. Follow up BABH

BEST
Start date: September 1, 2021
Phase:
Study type: Observational

Bevacizumab is widely prescribed for the treatment of severe bleeding related to epistaxis or gastrointestinal bleeding in HHT. We studied the efficacy of bevacizumab on severe bleeding in HHT patients in a randomized study recently published (NCT03227263, J Int Med 2023). In this study, 24 patients were included, 12 patients received bevacizumab and 12 patients received placebo. The duration of patient participation was 6 months, including the 2.5-month treatment period and 3.5 month follow-up after treatment. We describe the evolution of the number of RBC transfused in HHT patients who received bevacizumab during the year after the end of the study.

NCT ID: NCT06038877 Completed - Caregivers Clinical Trials

Opinions and Representations of Advanced Practice Nurses (IPA) in Nephrology in France on Clinical Research

EBIpa
Start date: October 10, 2022
Phase:
Study type: Observational

This single-center study will identify the representations and opinions of Advanced Practise Nurses (IPA) in nephrology in the Auvergne Rhône Alpes (AURA) region about clinical research. The study will consist of individual semi-directive interviews with Advanced Practise Nurses (IPA).