Caylus, France

Sleep Disorders in Specific Learning Disabilities

Quality of Information Provided During Antenatal Consultations

Long-Term Evaluation of TAILORED Vs Anatomical Ablation Strategy for Persistent Atrial Fibrillation

The TAILORED-AF study demonstrated at one year's follow-up that a tailored ablation strategy guided by Volta Medical AI-software targeting areas of spatio-temporal dispersed electrograms in combination with pulmonary vein isolation (PVI) ablation is more effective to an anatomical ablation strategy targeting PVI alone (current standard of care) for the treatment of persistent atrial fibrillation (AF). VX1 legacy device renamed Volta AF-Xplorer was used in the TAILORED-AF study in the treatment arm. No additional treatments are specifically required in the scope of this ancillary TAILORED-LT study which aims to follow the patients previously treated in the initial TAILORED-AF study over the long-term. However, in the event of repeat procedures during the TAILORED-LT study, the choice of the ablation technique will be left to the investigator's discretion, regardless of the patient's randomization arm in the TAILORED-AF study. The annual follow-up will be performed as in routine clinical practice post AF ablation procedures: visits at 24 months, 36 months, 48 months and 60 months post TAILORED-AF Study index procedure. It is possible that some of these annual visits cannot be completed prospectively due to time already having elapsed between the end of the subject participation in the TAILORED-AF study and the date of enrollment in the extension TAILORED-LT study. In this case, available data (among those expected by the study protocol) will be collected retrospectively. The additional procedures related to this clinical investigation are limited to annual 24-hour Holters and to the administration of Quality Of Life questionnaires (SF-36 and AFEQT) to the patients during follow-up visits.

Ziconotide for Non-cancer Pain by Intrathecal Administration

Evaluation of Maralixibat in Pruritus Associated With General Cholestatic Liver Disease (EXPAND)

This study will be conducted in multiple sites in North America, Europe, Middle East and South America.

Music Perception in SeLECTs

Self-limited epilepsy with centrotemporal spikes (SeLECTS) is the most frequent epilepsy syndrome in children between the ages of 4 and 13 years. The defining electroclinical feature of SeLECTS is the presence of centrotemporal spikes on EEG between seizures. SeLECTS is associated with specific cognitive deficits in 15 to 30% of patients, including disorders in language, visuo-spatial memory, explicit memory, and attention. The centrotemporal spikes are activated in sleep and, in rare cases, the condition has the potential to evolve into an Epileptic Encephalopathy with spike- and- wave activation in sleep (EE-SWAS), including Landau-Kleffner syndrome. The latest is characterized by symptoms of auditory agnosia and aphasia, with potential risks of persistent neuropsychological impairments. In a previous study, it has been shown that these patients also exhibit persistent musical difficulties. In the present project, the investigators intend to enlarge the understanding of cognitive deficits generated by SeLECTS in children by analyzing the integrity of music perception, both for melody and rhythm, as well as testing the potential of a musical intervention for auditory and cognitive training in children suffering from SeLECTS. The current research plan is to explore music perception in this specific epilepsy syndrome, with behavioral testing (Experiment 1) and neuroimaging using functional Near-Infrared Spectroscopy (fNIRS) (Experiment 2), and on the long run, informed by this exploration and previous studies, the design of a musical therapeutic intervention is envisioned in order to evaluate the impact of this program on music perception, language, and memory.

TTFields General Routine Clinical Care in ndGBM Patients: a French Prospective Non-Interventional Study (TIGER France)

GBM is one of the most common malignant primary brain tumor in adults with an overall incidence in Europe and in France of approximately 3/100,000. In France, 2,233 patients were estimated to be diagnosed with histologically-confirmed GBM in France in 2020. GBM are particularly aggressive and treatment resistant, with a 5-year overall survival (OS) of only 7.0 % in France. Since 2005, standard treatment for newly diagnosed GBM consists of maximal feasible surgical resection or biopsy followed by standard brain radiation therapy with concomitant temozolomide (TMZ) and a further 6 cycles of TMZ alone (Stupp protocol). This treatment demonstrated a significant increase in median OS compared to surgery and radiotherapy alone (14.6 vs 12.1 months). Since 2005, despite several of phase III clinical trials conducted, TTFields treatment was the first to report a significant improvement in GBM patients' survival compared to the previous standard of care. This pivotal phase III clinical trial randomized 695 patients with newly diagnosed GBM receiving either TTFields plus maintenance TMZ or TMZ alone, after completion of standard radiochemotherapy. Adding TTFields to maintenance TMZ significantly improved median progression-free survival (PFS) and median OS compared to TMZ alone. Impact of TTFields on survival appeared comparable to that achieved by the addition of TMZ to radiotherapy. These results led to FDA approval of Optune Gio® and to CE mark in the European Union in association with maintenance TMZ in patients with newly diagnosed GBM, after surgery and radiotherapy with adjuvant TMZ. Optune Gio® obtained national reimbursement in several European countries in this indication, as Germany, Switzerland, Sweden and France. The National Commission for the Evaluation of Medical Devices and Health Technologies (CNEDiMTS) issued on 20 July 2021 a positive opinion to Optune Gio® for inclusion into the reimbursement list in the following indication: "in association with maintenance TMZ, after surgery and radiochemotherapy in patients with newly diagnosed GBM, as part of a shared decision between the patient and the medical team". This prospective multicenter non-interventional study (NIS) aims at confirming the survival benefit of Optune Gio® - in terms of OS and PFS - and describing device usage (compliance will be measured through patient's usage report, recorded by each device) and impact on QoL, in a real-life setting in France, in a large cohort of participants with newly diagnosed GBM who completed radiotherapy and concomitant TMZ after surgery and initiating treatment with Optune Gio® device together with maintenance TMZ. A special emphasis will be given to the evaluation of QoL and the impact of Optune Gio® on daily life, considering the limited life expectancy of these patients, the symptom burden and significant disease-related disability.

Endovascular Preparation for Kidney Tranplantation

Prediction of Chronic Pain in Cardiac Surgery: Evaluation by Algocartography Predict-ALGOCARTE

A Study to Investigate LP352 in Children and Adults With Developmental and Epileptic Encephalopathies (DEE)