La Verenne, France
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.
Phase
N/ASpan
888 weeksSponsor
Hospices Civils de LyonLe Chesnay
Recruiting
Descriptive Study of Multiligamentary Reconstruction of the Knee
Phase
N/ASpan
131 weeksSponsor
Versailles HospitalLe Chesnay
Recruiting
Early Maladaptative Schemas Among Euthymic Patients With Bipolar Disorder in the Versailles FondaMental Advanced Centers of Expertise for Bipolar Disorders Cohort
Early Maladaptive Schemas (EMS) are overactivated in euthymic bipolar disorders (BD) and are associated with poor psychosocial functioning and higher suicidality. However, few studies have explored EMS in bipolar disorders, despite EMS therapy is a promising tool for the psychotherapy of BD. This study will use the data collected at the Versailles Expert Center for Bipolar disorder, in the local FACE-BD registry. These data will be collected at the inclusion, 12 months and 24 months later. They included an extensive neuropsychological battery and an extensive evaluation of the clinical characteristics of bipolar disorder. EMS will be measured with the Young Schema Questionnaire Short Form 3. The first objective of this study is to establish different clusters of EMS in euthymic bipolar disorders, compare these clusters according to the clinical characteristics of BD and neuropsychological performances and evaluate the temporal stability of these clusters at 12 and 24 months. The second objective of this study is to quantify the impact of EMS on functioning in euthymic BD, beyond the effect of cognition and residual depressive symptoms.
Phase
N/ASpan
805 weeksSponsor
Versailles HospitalLe Chesnay
Recruiting
Descriptive Study of the Reconstruction of Osteochondral Lesions of the Knee: Clinical and Imaging Results
Phase
N/ASpan
61 weeksSponsor
Versailles HospitalLe Chesnay
Recruiting
Posterior Reversible Encephalopathy Syndrome in the Critically Ill Patients
Phase
N/ASpan
565 weeksSponsor
Ictal GroupLe Chesnay
Recruiting
Healthy Volunteers
Status Epilepticus in the Critically Ill Patients
Phase
N/ASpan
566 weeksSponsor
Ictal GroupLe Chesnay
Recruiting
Healthy Volunteers
The Human Sperm Survival Assay (HSSA) as an Internal Quality Control for the IVF Consumables (REPROTOX 2)
The main objective is to assess the embryotoxicity of the main IVF consumables using the HSSA test before their introduction to the IVF laboratory.
Phase
N/ASpan
53 weeksSponsor
Ramsay Générale de SantéLe Chesnay
Recruiting
Assessment of the Quality of Life of Patients With Lymphomas Treated With Oral Therapy
Prospective longitudinal cohort. This observational study is monocentric. For each patient, data will be collected during 5 years.
Phase
N/ASpan
242 weeksSponsor
University Hospital, ToulouseLe Chesnay
Recruiting
Study of Lacutamab in Peripheral T-cell Lymphoma
Phase
2Span
330 weeksSponsor
The Lymphoma Academic Research OrganisationLe Chesnay
Recruiting
Prospective Non-interventional Study of Adult Patients With Acute Myeloid Leukemia (AML)
During the last fifteen years, the landscape of AML diagnosis and therapeutical options has markedly evolved. Refined genetic and prognostic characterizations, together with new drug approvals and new allogeneic hematopoietic stem cell transplantation (HSCT) procedures, have increased patient journey diversity. I - At initial AML diagnosis, not all newly diagnosed patients are entering clinical trials. A substantial proportion of them are treated with standard therapies outside of any trial. To date, the standard approved frontline treatment options include: 1. Standard intensive 3+7 (anthracycline + cytarabine) chemotherapy ± an approved FLT3 inhibitor (midostaurine, Rydapt®), according to different dose schedules in older versus younger patients 2. Combination of sequential gemtuzumab ozogamicin (GO, Mylotarg®) with 3+7 3. Liposomal formulation of daunorubicin + cytarabine (CPX-351, Vyxeos®) 4. Less intensive chemotherapy with azacytidine or low dose cytarabine (LDAC) in patients considered as not eligible for the more intensive options above The investigator's choice is guided by AML and patient's characteristics, and by the approved indications for each of these treatment options. This study will thus start including these specific options. Further study amendments might be necessary in case of new standard treatment definition. II - Secondly, no specific salvage regimen has emerged as a standard in patients with primary refractory or relapsed AML (R/R AML). R/R AML is thus an important field for investigational new drugs (INDs) and precision medicine development. To date, the only IND approved to treat R/R AML is gilteritinib for FLT3-mutated AML patients. The French agency ANSM also allow to use GO for treating R/R AML patients in the frame of a RTU (Recommendation Temporaire d'Utilisation). In the "real life", because of the multiplicity of treatments used in these patients, some of them being now quite efficient, it has become difficult to accurately describe the general outcome of R/R AML patients. III - Thirdly, allogeneic HSCT is no more considered at the ultimate and final goal of AML therapy in all patients, as it was in the past. Transplant indications have been better described and HSCT in now evaluated in the context of the whole treatment course, including pre- and post-transplant therapy, as well as pre- and post-transplant minimal residual disease (MRD) levels. For all these reasons, it is of utmost importance to document the various characteristics, treatments and outcomes of patients treated in the real-life, outside of clinical trials, for 1) real-world treatment evaluation; 2) post-approval use of recently approved drugs; 3) standardization and improvement of routine patient management; and 4) better disease understanding.
Phase
N/ASpan
1251 weeksSponsor
Acute Leukemia French AssociationLe Chesnay
Recruiting