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NCT ID: NCT05209815 Completed - Multiple Sclerosis Clinical Trials

Safety of Exposure to Natalizumab During Pregnancy

BABYZUMAB-2
Start date: June 20, 2022
Phase:
Study type: Observational

Multiple sclerosis (MS) preferentially affects young adults with a female predominance. MS is not associated with an increased risk of complications or abnormal pregnancy outcomes. Nevertheless, disease-modifying therapies can have a teratogenic effect. Discussions about discontinuation should be made with a view to or upon discovery of pregnancy, taking into account the risk of untreated relapses and the risk of toxicity to the fetus. Natalizumab (NTZ) is a humanized anti-alpha4-integrin monoclonal antibody used as a treatment for highly active relapsing-remitting MS (RRMS). When it is stopped, there is frequent reactivation of the disease with possible relapses and a rebound effect could occur. At present, depending on the center, attitudes of neurologist may vary and 3 main scenarios can be observed: Pregnancy and postpartum under NTZ (group1), Pregnancy partially under NTZ (with or without immunomodulator (IM) supplementation, group 2), or NTZ stopped before pregnancy (with or without IM supplementation, group3). The first part of the BABYZUMAB study, a retrospective study of Natalizumab exposure during pregnancy, analysed the comparison the clinical activity of the disease (annualized relapse rate) according to these 3 scenarios of NTZ treatment The investigators analyzed the annual relapse rate (ARR) during a two-year period (9 months before and 15 months after the beginning of the pregnancy) in 117 patients identified in the OFSEP database. The investigators showed that the risk of relapses was four times higher in Group 2 versus Group 1 (p=0,014) and six times higher in Group 3 versus Group 1 (p=0,001). In the literature, there are few studies of newborns from NTZ-exposed pregnancies. No specific pattern of birth defects has been found, but mild to moderate transient thrombocytopenia and anemia have been reported in infants born to NTZ-exposed mothers in the third trimester of pregnancy.

NCT ID: NCT04605250 Completed - Clinical trials for Postoperative Pulmonary Complications

Respiratory Variability for Respiratory Monitoring During the Postoperative Recovery Period

VariaRessPi
Start date: May 21, 2019
Phase: N/A
Study type: Interventional

The research consist of measuring respiratory variability of several variables of the respiratory pattern at rest and during exercise using a thoracic movement measuring technique. The objective is to confirm the ability of this technique to measure the respiratory variability in healthy subjects comparing to flow measurements by a pneumotachograph. In a second step, the thoracic movement technique is applied to measure respiratory variability before and after surgery in patients after abdominal surgery with laparotomy. The objective is to observe a decrease of variability in subjects developing or at risk to develop a postoperative pulmonary complication.

NCT ID: NCT04479670 Completed - Clinical trials for Psychological Trauma

Psychometric and Patholinguistic Assessment of Psychotrauma Related to Natural Hazards in the Commune of "Le Prêcheur"

EP3LAN
Start date: March 26, 2021
Phase:
Study type: Observational

The project is to study the evolution of mental health in a little town of the French Martinique (Le Prêcheur) by using an innovative method of analysis that combines patholinguistic and psychometric indications for patients who risk of developing psychotrauma due to a natural hazard. Investigators will gather precise and factual data concerning the psychic and mental state of the population, by collecting patients' feelings and sentiments through individual interviews and audio recordings that will be then transcribed, and analyzed, and repeated, according to a quantitative, qualitative, and prospective methodology. This research is launched in order to meet the needs expressed both by the French authorities and the population towards an optimization of crisis management.

NCT ID: NCT04453384 Completed - SARS Virus Clinical Trials

Study to Evaluate the Safety and Efficacy of XAV-19 in Patients With COVID-19 Induced Moderate Pneumonia

POLYCOR
Start date: September 1, 2020
Phase: Phase 2
Study type: Interventional

Early inhibition of entry and replication of the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is a very promising therapeutic approach. Polyclonal neutralizing antibodies offers many advantages such as providing immediate immunity, consequently blunt an early pro-inflammatory pathogenic endogenous antibody response and lack of drug-drug interactions1-3. Because a suboptimal endogenous early antibody response with regard to SARS-CoV-2 replication in severe cases is observed, neutralising antibody treatment can be very interesting for patient with COVID-19 induced moderate pneumonia4,5. Convalescent plasma to treat infected patients is therefore an interesting therapeutic option currently under evaluation. However, the difficulties of collecting plasma and its safety aspects are not adapted to many patients. A new polyclonal humanized anti-SARS-CoV2 antibodies (XAV-19) is being developed by Xenothera, which can be administered as intravenous treatment. XAV-19 is a heterologous swine glyco-humanized polyclonal antibody (GH-pAb) raised against the spike protein of SARS-CoV-2, inhibiting infection of ACE-2 positive human cells with SARS-CoV-2. Pharmacokinetic and pharmacodynamic studies have been performed in preclinical models including primates and a First In Human study with another fully representative GH-pAb from Xenothera is ongoing in volunteer patients recipients of a kidney graft. These studies indicated that 5 consecutive administrations of GH-pAbs can be safely performed in humans. The objective of this 2-steps phase 2 randomized double-blind, placebo-controlled study is 1) to define the optimal and safety XAV-19 dose to administrate in patients with COVID-19 induced moderate pneumonia ; 2) to show the clinical benefit of selected dose of XAV-19 when administered to patients with COVID-19 induced moderate pneumonia.

NCT ID: NCT04415229 Completed - Clinical trials for Bronchiolitis; Respiratory Syncytial Virus

RSV Seasonality in Martinique in Children Aged 2 Years or Less

VRS-12
Start date: October 2, 2019
Phase:
Study type: Observational

The epidemiological characteristics of RSV bronchiolitis differ between tropical and temperate zones. This study seeks to understand which climatic factors could influence the specific seasonality of these bronchiolitis in Martinique and to verify the hypothesis put forward: influence of favorable climatic conditions in the month preceding the start of the epidemic. In addition, the study will improve our knowledge of the epidemiology of the infection in order to improve the management of infants.

NCT ID: NCT04413890 Completed - Labor Complication Clinical Trials

Comparison of Two Rhythm of Administration of Prostaglandin Gel for Induction of Labor

GELFREQ
Start date: December 17, 2019
Phase: Phase 2
Study type: Interventional

The study compares two rhythms of administration of prostaglandin vaginal gels for cervical priming before induction of labor in term patients. In our institution, prostaglandin gels are given for a maximum of three times, with induction by oxytocin and amniotomy the day after the last gel whatever Bishop score has been obtained. This management results in some patient spending four days in hospital before delivery. The aim of the study is to compare our classical management scheme with a reduced interval between to gels, of 12h instead of 24 h. The primary outcome will be the time elapsed between the first prostaglandin gel and delivery. Tolerance of both management patterns will also be evaluated through a satisfaction survey.

NCT ID: NCT04375748 Completed - Acute Myocarditis Clinical Trials

Hospital Registry of Acute Myocarditis: Evolution of the Proportion of Positive SARS-COV-2 (COVID19) Cases

MYOCOVID
Start date: April 15, 2020
Phase:
Study type: Observational

To date, the effects of SARS-Cov-2 (Covid-19) on the myocardium and the role it plays in the evolution towards an acute myocarditis are badly understood. The current pandemic of this emerging virus is an opportunity to assess the proportion of acute myocarditis attributable to SARS-Cov-2(Covid-19) and to assess the clinical, biological and imaging presentations, by means of a national prospective multicentre hospital registry of cases of acute myocarditis.

NCT ID: NCT04373759 Completed - Covid-19 Clinical Trials

Cardiac Arrest Incidence and Outcome Among Patients With COVID-19 in French ICUs

ACICOVID
Start date: May 2, 2020
Phase:
Study type: Observational [Patient Registry]

Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is responsible for the novel coronavirus disease 2019 (COVID-19) pandemic. Among COVID-19 complications, in-hospital cardiac arrest (IHCA) was reported with a very poor outcome in a retrospective single-center study (0,7% of 30 days survival with good neurological outcome among IHCA patients with a resuscitation attempt), related to its natural course and management. The incidence of unexpected in-ICU cardiac arrest (ICUCA) due to COVID-19 is still unknown. Additionally, outcome of COVID-19 patients admitted in ICU for an out-of-hospital cardiac arrest (OHCA) is also undescribed. The objective this study is : - to report the incidence of ICUCA among patients hospitalized in French ICU for COVID-19. - to report morbidity and mortality among COVID-19 patients admitted alive in ICU for an OHCA or an IHCA. The secondary objective is to assess outcome and identify risk factors of ICUCA occurrence among patients admitted for COVID-19.

NCT ID: NCT04076683 Completed - Sickle Cell Disease Clinical Trials

Algorithm for Apherisis Monitoring and Prescription Assistance in Sickle Cell Patients (ALGODREP)

ALGODREP
Start date: January 5, 2022
Phase: N/A
Study type: Interventional

The main objective of this study is to prove the superiority of a procedure which calculates the volume of RBCs to transfuse and the time between apheresis based on this algorithm, compared to the current procedure. The primary endpoint would be the number of patients with individually achieved objectives in terms of % HbS before each apheresis (which reflects the effectiveness of the previous apheresis) over a period of 12 months. The secondary objectives would be to compare the volume differences of transfused RBCs in both groups over a period of 12 months, the occurrence of clinical events and the satisfaction of patients and physicians. The investigators hope that this study would improve the efficiency and the performance of apheresis in sickle cell patients. The investigators also hope to facilitate the organization of procedures with the flexibility that would allow the use of this algorithm.

NCT ID: NCT03919357 Completed - Clinical trials for Developmental Disability

Using a New Calibrated Tool in Specific Language and Learning Disorders : the BMTi

ValidBMTI
Start date: March 7, 2019
Phase:
Study type: Observational

The group of experts at HAS has defined the places of first and second-line workers in specific disorders of development and learning, as defined in the international diagnostic classifications International Classification of Diseases (CIM) CIM 11 and Diagnostic and Statistical Manual of Mental Disorders (DSM) DSM 5. The referral to a second-level structure, a multidisciplinary structure in charge of carrying out the different cognitive assessments, requires a preliminary evaluation. This orientation is based on a medical consultation, carried out by a doctor specialized in the field, with an exploration tool adapted to the different fields concerned. The BMTi, a battery of third-generation tests (after the Rapid battery of evaluation of the cognitive functions (BREV) and then the Evaluation of cognitive functions and learning of the child (EDA)) will enable the doctor, from 2018, to carry out this orientation in a relevant way in response to children with a complaint about neurodevelopment and learning. . The research project aims to validate this hypothesis, by comparing the diagnoses posed in a conventional way with the various multidisciplinary assessments, with the results of the transfer of all or part of the subtests of the BMTi by a doctor of second resort.