Camberley, Surrey, United Kingdom

Rocket Study: A Study to Characterize Biomarkers and Disease Progression in Participants With Pelizaeus-Merzbacher Disease

This is a multi-center, non-randomized, non-interventional integrated prospective and retrospective study in up to 32 participants with PMD who can undergo general anesthesia or conscious sedation (if necessary) to collect fluid biomarkers (CSF and blood), neuroimaging, and clinical assessments to be used in support of the development of therapies for PMD. The study duration for each participant will be approximately 26 months (Week 106).

Evaluation of the Impact of Case Manager Intervention on the 3-year Psychotic Episode Recurrence Rate in Patients Aged 16 to 30 Years with a First Psychotic Episode.

French Validation of a Severity Scale in REM Sleep Behavior Disorder (SEV-TCSP)

Research involving the human person, non-interventional, category 3 80 patients with RBD of any etiology (eg Idiopathic RBD, RBD associated with Parkinson's Disease, Multiple System Atrophy, Narcolepsy etc.) and their bedpartners (if available) will be include in 5 French centers (Clermont-Ferrand, Paris, Nantes, Montpellier et Lyon) Patients, and their bedpartners (if available), will be seen 2 times at 1 week intervals. For the patients Visit 1 (Day 0): duration : 60 minutes - Information to patient and collection of non-opposition - Collection of socio-demographic data: age, sex, level of education - Clinical data collection: duration of RBD, duration and severity of the concomitant disease:, medical and surgical history - Assessment of cognitive functions: Mini Mental State Examination - Verification of inclusion / exclusion criteria - Ongoing treatments and calculation of Levodopa Equivalent Daily Dose (LEDD) for PD patients. - RBD severity scale for Patient (RBDSS-PT) + Global Clinical Impression-Severity Scale Visit 2 (J7) : duration : 20 minutes - Ongoing treatments - RBDSS PT + Global Clinical Impression-Severity Scale (CGI-S-PT) - Patient will be given a Weekly Severity Agenda for 4 weeks plus a copy of the RBSSS-PT + Global Clinical Impression-Severity Scale At home, patients will fill : D8 à D36 : • Weekly Severity Agenda (wRBDQ) for 4 weeks D36 : - RBDSS-PT + Clinical Global Impression-Severity These documents will be mailed back in a pre-payed envelop. For the Bed Partners Visit 1 (D0- baseline): duration: 30 minutes - Information of and collection of non opposition - Collection of socio-demographic data: age, sex, level of education - Assessment of cognitive functions: Mini Mental State Examination - Verification of inclusion / exclusion criteria - Ongoing Treatments - RBD severity scale of the bed partner (RBDSS BP)+ Global Clinical Impression-Severity Scale Visit 2 (D7- retest) : duration : 20 minutes - Ongoing treatments - RBDSS-BP + Clinical Overall Impression Severity Scale - Patient will be given a Weekly Joint Severity Agenda to be completed together with the patient, (wRBDQ) for 4 weeks, plus a copy of the RBDSS-BP + CGI-S-BP At home: bedpartners will fill: D8 à D36 : • Weekly Severity Agenda for 4 weeks, in common with patient D36 : • RBDSS-BP + Impression Global Clinique-Severity scale These documents will be mailed back in a pre-payed envelop.

Impact of Early Debriefing and Enhanced Educative Components on Direct Oral Anticoagulant Adherence After Venous Thromboembolism.

Venous thromboembolism (VTE) is a frequent multifactorial and potential life-threatening disease. Once VTE has been diagnosed, anticoagulation should be started and prolonged for at least three to six months in order to reduce the risk of fatal and non-fatal recurrences and long-term sequelae. The development of direct oral anticoagulants (DOACs) has represented a major advance in patients' care as there is evidence that DOACs are associated with a decreased risk of bleeding without loss in efficacy and as it simplifies treatment modalities for the patients and the physician. However, as DOACs do not require laboratory monitoring, adherence of anticoagulation is difficult to evaluate and traditional programs built on patients receiving VKA may no longer be applicable to patients on DOAC. In order to increase treatment adherence in patients on DOAC for an acute VTE and to improve the quality of life, the impact of specific educational programs on DOACs, taking in account both therapeutic (DOAC) and medical illness (VTE) dimensions needs to be investigated. Design The "DEBRIEF-VTE" trial is a multicenter randomized trial with blind evaluation and using a Zelen randomization process comparing a standardized follow-up visit at one month associated with a "debriefing and enhanced educative components" versus a standardized follow-up visit at one month alone (i.e.; without debriefing process). All patients meeting the inclusion and none of the exclusion criteria are eligible for randomization. They will be randomized 1:1 to one of two allocated groups: - Experimental group: a standardized follow-up visit at one month associated with "debriefing and enhanced educative component" - Control group: a standardized follow-up visit at one month alone (i.e.; without "debriefing and educative component") Randomization will be performed using a two-step methodology described by Zelen et al. - Stratification by: - Center - DVT or PE - Presence of a major risk factor (either transient or persistent) or not (unprovoked VTE) At visit 1 (inclusion, 0-7 days): Inclusion of patients using the first written informed consent to accept a standard follow-up (visit at 1 month and 6 months) without mentioning randomization at one month performed in order to allocate patients to have, or to not have, debriefing and enhanced educative components. Study medication will be administered with complete explanation about doses and a classical therapeutic information regarding DOAC and clinical signs of recurrent VTE and bleeding (one treatment box with 400 pills of apixaban at 5 mg for the first 6 months of therapy) will be performed. Visit 2 (30 days): - Before the visit 2, review of all the inclusion and exclusion criteria and compute creatinine clearance using Cockcroft-Gault method ; if all eligibility criteria are satisfied, randomization of the patient; - After randomization, during the visit 2: - For patients allocated to the experimental group: signature of the second written informed consent describing the debriefing and enhanced educative components and objective on quality of life - For patients allocated to the control group: no second written informed consent is required Visit 3/ET (180 days): - Evaluate quality of life (PembQOL if PE, VEINES-Qol if DVT, EQ-5D for all patients), residual symptoms (mMRC and MDP scale if PE, Villalta if DVT) depression (HAD), recurrent VTE, bleeding, hospitalizations, death The primary objective is to demonstrate that, in patients with an acute episode of VTE treated for at least 6 months, early debriefing and enhanced educative components added to a standardized visit one month after an acute VTE is associated with an increased adherence to apixaban therapy at 6 months than after a standardized visit alone at one month (adherence measured by the MEMSCap™ Medication Event Monitoring System Cap (WestRock, USA & Switzerland). In patients with an acute episode of VTE treated for at least 6 months, the main hypothesis is that early debriefing and educative components added to a standardized visit one month after an acute VTE has the potential to improve patient's adherence to APIXABAN therapy at 6 months of follow-up. Secondary objectives are to evaluate the impact of early debriefing and enhanced educative components added to a standardized visit one month after an acute VTE on the following at 6 months of treatment : quality of life (EQ-5D for all, PembQOL if PE, VEINES-Qol if DVT), residual symptoms (MMRC and multidimensional dyspnea profile(MDP) scales if PE, Villalta if DVT), depression (HAD), recurrent VTE, bleeding,hospitalizations and death. 150 patients will be included Duration of the inclusion period: 18 months Duration of participation for each patient: 6 months Total duration of the study: 24 months

Evaluation of Professional Practices in the Treatment of Refractory Idiopathic Overactive Bladder at the Dose of 50 Units (TOX50IUU)

Currently, Botox injection is one of the second-line treatments for urinary incontinence by idiopathic overactive bladder. Multiple studies have shown that Botox at the dose of 50UI is effective but not for a long time. Maximum efficiency is about two weeks and until about twelve weeks compared to the dose between 100UI and 300UI that shown an efficiency until twenty-four at thirty-six weeks. But it's not without consequence since the side effects are more numerous increasing the dose. The most frequent are urinary retention with necessary to perform clean intermittent catheterization and urinary infection. This dose at 50UI is therefore more a test to assess the patient's tolerance to the product, as recommended by the product marketing authorization. So, through this evaluation of professional practices, investigators would like to evaluate the patient satisfaction treated in hospital, with a first dose at 50UI.

Observation of Clinical Routine Care for Patients With BIOTRONIK Implantable Cardiac Monitors (ICMs)

Brain-injured Patients Extubation Readiness Study

Severe brain-injured patients need mechanical ventilation with tracheal intubation. After treatment of the acute neurological condition, weaning of the mechanical ventilation has to be initiated notably to prevent ventilator associated pneumonia and others complications. Nevertheless, extubation failure is very common in this population due to residual neurological impairment with airway control alteration. Guidelines about weaning of mechanical ventilation and extubation exclude brain-injured patients with a residual impaired consciousness. In 2017, a simple and pragmatic extubation readiness clinical score was validated in a prospective observational cohort study of 140 brain injured patients. (Godet et al. Anesthesiology. 2017 Jan;126(1):104-114) In this study, brain injured patients with residual impaired consciousness who succeeded a spontaneous breathing trial were extubated. In multivariate analysis, 4 clinical elements were associated with extubation success. A prediction score was determined using the odds ratio such as followed : 1. Deglutition: 3 points if present 2. Gag reflex: 4 points if present 3. Cough: 4 points if present 4. CRS-R Score, visual item > 2, 3 points if present, 1 point if not For a cut-off value of 9, extubation failure could be predicted with a sensibility of 84%, a specificity of 75%, a positive predictive value of 89% and a negative predictive value of 66%. In order to participate, brain-injured patients will have to succeed a spontaneous breathing trial and meet all inclusion criteria, including not being able to obey to simple orders without sedation. Using a stepped wedge randomisation process with intensive care units as clusters, patients will be weaned and extubated under usual care or using the extubation readiness clinical score. The authors' hypothesis is that this clinical score will allow physicians to extubate patients at the right time interval and prevent extubation failure in this frail population.

French Registry for Monitoring Pregnancies for Multiple Sclerosis

METHODOLOGY Prospective, observational, multicentric and national epidemiological study, within the scope of the OFSEP, including all groups of patients eligible to participate in the Observatoire Français de la Sclérose en Plaque (OFSEP) (definite MS, radiologically isolated syndromes, clinically isolated syndromes, neuromyelitis optica (NMO) and NMO spectrum disorders), with no age limit and an ongoing pregnancy. Women will be followed during pregnancy and in the year after and their children until 6 years of age. STATISTICAL ANALYSIS To be determined for each specific question. EXPECTED RESULTS Interactions between pregnancy and MS course have been well characterized before the therapeutic era. Neurologists and patients are lacking information to weigh benefits and risks of DMDs used immediately before or during pregnancy, including short and long-term risks to the mother and to the child, but also after delivery. This study should help provide better answers to those questions as well as to still controversial questions about locoregional analgesia and breastfeeding. By following these patients within the Observatoire Français de la Sclérose en Plaque (OFSEP) cohort, the investigator will also have access to a comprehensive description of MS before pregnancy but also in the long term.

Internet Tools and Emergency Attendance

It is an observational study, monocentric, prospective. This study consists in collecting data from an anonymized questioner given to patients presenting themselves at the emergency department of Clermont-Ferrand University Hospital. Answers to the questions will not change the patient's management. The questioner, containing 17 questions, requires answering "yes" or "no" by ticking boxes, or even specify when it is stipulated. This questionnaire will be given to the patient after his registration, and filled by the latter in the waiting room, pending medical care. Answering the questionnaire will take between 5 to 10 minutes. The data is anonymous. The patient arrives at the emergency department and registers at the entrance desks where a paper and computer file is created. Then, the Reception and Orientation Nurse takes care of the patient by welcoming him in the reception box, she realizes the taking of the hemodynamics constants, the collection of the reason of consultation with the grievances of the patient. During this phase, patient will be inform of the completion of this study and asked to participate in this study. If the patient agrees to participate, an anonymized questioner will be provided and explained by one of the investigating physicians or associated partners.

Early Detection of Burnout - Healthcare Workers

Early detection of burnout was designed to provide a better understanding of warning sign of burnout in order to detect earlier workers at risk. In the present protocol, parameters are measured on several occasions (0, 1 week, at 6 month, at 12 months and then at each occupational visit within 5 years). Statistical analysis will be performed using Stata software (version 13; Stata-Corp, College Station, Tex., USA). All statistical tests will be two-sided and p<0.05 will be considered significant. After testing for normal distribution (Shapiro-Wilk test), data will be treated either by parametric or non-parametric analyses according to statistical assumptions. Inter-groups comparisons will systematically be performed 1) without adjustment and 2) adjusting on factors liable to be biased between groups. Analysis will be performed using anova or Kruskal-Wallis (KW) tests. When appropriate (p<0.05), a post-hoc test for multiple comparisons (Tukey-Kramer after anova and Dunn post KW) will be used. Comparisions of categorical variables will be performed using Chi-squared or Fischer test. Marascuillo's procedure will be performed for multiple comparisons. Relations between quantitative outcomes will be analyzed using correlation coefficients (Pearson or Spearman). Fisher's Z transformation and William's T2 statistic will be performed to compare correlations between variables and within a single group of subjects. Longitudinal data will be treated using mixt-model analyses in order to treat fixed effects group, time and group x time interaction taking into account between and within participant variability.