title: The Somatic-to-cerebral Oxygen Saturation Gradient as a Non-invasive Index of Anaerobic Threshold in High-risk Cardiac Surgical Patient

summary: In patients undergoing cardiac surgery under cardiopulmonary bypass, some organs like brain and heart are preserved while others (skin, gut and skeletal muscle) are being underperfused. This phenomenon is related to silent peripheral vasoconstriction that is not clinically available but threatens end-organ perfusion and carries the risk of multi-organ failure. By measuring non-invasively the somatic-to-cerebral oxygen saturation gradient, the present study aims at detecting silent peroperative hypoperfusion episodes. The investigators hypothesize that gradient, measured during the surgical procedure, will predict the occurrence of anaerobic metabolism, ascertained by an elevation of blood lactate concentration, measured in intensive care unit.

location_facility: Pôle d'anesthésie réanimation - Nouvel Hôpital Civil


type: Other Identifier

title: Follow-up of People at Risk of Monkeypox Infection: a Prospective Cohort Study

acronym: MonkeyVax

summary:
Since one month (first case confirmed the 05/06/2022), some cases of non-imported were reported by Portuguese and British authorities then in several Europeans countries, the US and the Canada. The 05/19/2022, a first case of Monkeypox was confirmed in France. The 06/01/2022, "Santé Publique France" (SPF) declared 33 confirmed cases of Monkeypox without a direct interaction with people returning from endemic area. No deaths are currently recorded.

Currently, data on efficiency of modified vaccinia Ankara virus (MVA) used in post-exposure prophylaxis are few. The Centers for Disease Control and Prevention (CDC) consider that 2 doses of MVA vaccine used in post-exposure vaccination do not prevent totally the infection but consider that one rapid vaccination of high-risk contacts could reduce the severity of symptoms.

In order to clarify clinical impact and safety of PEV, it is proposed to set up a national cohort including people at risk of Monkeypox infectionfalling within the indications for vaccination, i.e. seen within 14 days of last contact for post-exposition (PEP) cases and also in prevention :pre-exposition ( PrEP)cases.

The purpose of this study is to estimate the failure rate of the vaccinationby the VMA vaccine in PEP or PrEP administration in people at risk of Monkeypox infection after one dose.

study_start_date_type: Actual

status: Active, not recruiting

study_completion_date_type: Anticipated

study_type: Interventional

design_allocation: Non-Randomized

primary_purpose: Prevention

enrollment_type: Actual

ipd_sharing: No

lead_sponsor: Assistance Publique - Hôpitaux de Paris

intervention_type: Biological

lead_sponsor_type: academique

status_simplified: Ongoing


title: E3CAPS: Improvement of the Safety of Care in Cataract Surgery Teaching on Eyesi Simulator: Learning Curve and Impact of Sleep Deprivation on Residents in Ophthalmology

summary: The aim of this project is to reduce the risks of cataract surgery using the EyeSi simulator Axis 1: to model the learning curve of novice residents in Ophthalmology who follow the training program recommended by the "Collège des Ophtalmologistes niversitaires de France" (COUF) in order to help creating a "licence to operate" Axis 2: to evaluate the impact of sleep deprivation on the surgical performance of experienced residents in Ophthalmology

status: Recruiting

primary_purpose: Health Services Research

enrollment_type: Anticipated

lead_sponsor: Nantes University Hospital

sponsor_collaborators:
Nantes University Hospital
University Hospital, Tours
Rennes University Hospital
University Hospital, Angers

location_facility:
CHU Tours
CHU Nantes

intervention_type: Other


title: National, Multicentric, Prospective Phase II Study Estimating the Interest of a Dose Decrease for Radiation Therapy Associated With a Carboplatine and Etoposide Based Chemotherapy for the Treatment of Standard Risk Adult Medulloblastomas

summary:
Adult medulloblastoma is a rare tumour.

The "standard risk " group (complete surgery or residual tumour lower than 1,5 cm2, absence of malignant cells in the cerebrospinal fluid, absence of metastasis, absence of MYC amplification and exclusion of large cells medulloblastoma) concerns, for the adult population, a majority of patients at diagnosis (about ¾ of cases).

Conventional treatment is classically based on a 54/36 Gy cranio-spinal radiotherapy (54 Gy on the posterior fossa and 36 Gy on the nevraxis).

This treatment is associated with an acute toxicity (haematological, cutaneous, digestive and general) wich decreases gradually when patient goes away from the treatment period.

For this category of patients and this modality of treatment, The French intergroup experience, pleads in favour of a late and progressive neurotoxicity.

This neurotoxicity is associated with a clear degradation of the quality of life.

In the light of paediatric studies :

We propose a phase II study to estimate the interest of a decrease of radiation doses compensated by a chemotherapy according to the following schedule

carboplatine + etoposide based chemotherapy every 28 days x 2
followed by, less than 80 days after the surgery, radiation therapy with 24 Gy on the in toto neuro axis and 54 Gy on the post operative bed.

The majority of French centres concerned with the neuro-oncology are involved in this trial.

About 25 new cases by year are waited. A centralized analysis of pathological slides and of the pre and post surgery Magnetic Resonance Imaging is foreseen.

The main objective is to estimate the survival without disease at 1 year

Secondary objectives associate the evaluations of the rate of complete response at the end of procedure, the overall survival, the survival without disease, the survival without events, the neurocognitiv toxicity, the endocrine toxicity, the hearing toxicity and the time until definitive deterioration of the quality of life Associated studies

Two associated studies are besides foreseen (parallel search for co-financing):

A biologic study is planed with the aim to confirm, by morphological, genomic and transcriptomic studies, the interest, for the adult population, of the prognostic markers used in paediatric population

A radiological study is planed with the aim to estimate the interest :

of a multimodal follow-up (spectroscopy and perfusion imaging) for the premature detection of recurrences
of the study of functional connectivity in correlation with the neuropsychological follow-up for the analysis of the aetiology and premature markers of neurotoxicity.

status: Unknown status

primary_purpose: Treatment

lead_sponsor: Central Hospital, Nancy, France

collaborators: Centre Hospitalier Universitaire de Nice

collaborators: Gustave Roussy, Cancer Campus, Grand Paris

collaborators: Centre Hospitalier Universitaire, Amiens

location_facility: AP HP Groupe Hospitalier Pitié Salpétrière

intervention_type: Drug

status_simplified: Unknown


type: Registry Identifier

title: Evaluation and Validation of a Multimodal MRI Neuroimaging Method: Application to Differential Diagnosis and Disease Progression in Parkinsonian Syndromes

acronym: MultiPAMS

summary: Based on previous promising results, the next step for the validation of a multimodal MRI method in diagnosis and follow up of patients reached by parkinsonian syndromes is (i) to test whether the multimodal neuroimaging is able to discriminate at the individual level, patients with multiple system atrophy parkinsonism (MSA) and patients with idiopathic Parkinson's disease (PD) (ii) to determine whether the method is sensitive to measure changes over time for the two diseases, according to imaging, neuropsychological and other clinical data. Patients will be compared with healthy controls.

status: Completed

study_completion_date_type: Actual

primary_purpose: Diagnostic

lead_sponsor: Institut National de la Santé Et de la Recherche Médicale, France

status_simplified: Completed


title: Determination of Left Ventricular Ejection Fraction Using Cardiac Angioscintigraphy: Comparison Between Measurements Obtained With Conventional Planar Scintigraphy (E-CAM Camera) and Tomoscintigraphy Recorded by a CZT Semiconductor Camera (D-SPECT)

acronym: FEVED

summary:
The purpose is to determine whether measurements of left ventricular ejection fraction (LVEF) obtained with angiographies recorded by conventional Anger camera or D-SPECT camera are equivalent.

Secondary purposes are:

To evaluate the influence of cardiac activity recorded by D-SPECT camera on equivalences defined in primary purpose
To evaluate the influence of the indication for the examination with a distinct analysis of a group having the examination for a known or suspected cardiomyopathy (LVEF often abnormally low) and a group having the examination for a chemotherapy supervision with heart initially considered healthy (LVEF often normal).

location_facility: CHU de NANCY - Service de Médecine Nucléaire


title: Multimodal and Longitudinal Assessment of MOBility Disorders in Patients With Mild COGnitive Disorders

acronym: COG-MOB

summary:
Mild cognitive impairment (MCI) is defined by lower performance in one or more cognitive domains with preservation of independence in functional abilities. Sixteen percent of community-dwelling older people (over 65 years) live with MCI. They are both cognitively and physically vulnerable. From a cognitive perspective, they are susceptible to converting to the dementia stage at an annual rate of 10%. From a physical perspective, the proportion of slow gait or neurological gait abnormalities can reach 46% in the population with MCI. Falls in turn increase the risk of accelerated cognitive decline and the risk of institutionalization. In the absence of a curative treatment for dementia, it is essential to have an effective and personalized prevention strategy by identifying the predictive factors for falls in this at-risk population with MCI.

The research goals of this project are 1) to identify specific predictors for falls in clinic attendees with MCI in preparation for a definitive, fully powered study across France, and 2) to demonstrate the feasibility of a pragmatic fall risk assessment in MCs, whatever its setting and location.

We aim to prospectively follow-up people diagnosed with MCI and aged above 65 years old in four MCs in France (three in the North (one community-based MC), and one in the Centre) for one year.

study_type: Observational

time_perspective: Prospective

lead_sponsor: University Hospital, Lille

location_facility:
Les Bateliers Chu Lille
Hop Salengro - Hopital B

intervention_type: Behavioral


title: Phase II Trial of a Vaccination With Tumor Antigen-loaded Dendritic Cell-derived Exosomes on Patients With Unresectable Non Small Cell Lung Cancer Responding to Induction Chemotherapy

acronym: CSET 1437

summary: Lung cancer is the worldwide leading cause of cancer death. In France, with 28,000 new cases per year, lung cancer is the 4th in terms of incidence but remains the leading cause of cancer death. The 5-year survival of lung cancer, all stages and all types, is very low, estimated at 12% among men and 16% among women in France. In advanced unresectable non small cell lung cancer, standard treatment relies on platinum-based induction chemotherapy. The median progression-free survival (PFS) in patients responding or stabilized after 4 chemotherapy cycles ranges from 2 to 2.8 months. Gustave Roussy and Curie institutes have developed an immunotherapy involving metronomic cyclophosphamide (mCTX) followed by vaccinations with tumor antigen-loaded dendritic cell-derived exosomes (Dex). mCTX inhibits Treg functions restoring T and NK cell effector functions and Dex are able to activate the innate and adaptive immunity. Phase I trials showed the safety and feasibility of Dex vaccines but no induction of T cells could be monitored in patients. Since 2007, we validated a new process for isolation of second generation Dex with improved immune stimulatory capacities. We propose a maintenance immunotherapy in 47 advanced unresectable NSCLC patients responding or stabilized after induction chemotherapy with Dex-based treatment to improve PFS rate at 4 months in these patients.

lead_sponsor: Gustave Roussy, Cancer Campus, Grand Paris


title: Development and Validation of a Comorbidity Index in Crohn's Disease

acronym: NEMO-Index

summary: Crohn's disease (CD) is a chronic inflammatory bowel disease (IBD). Like other chronic diseases, patients with CD may be affected by other diseases called comorbidities. The prevalence of comorbidities in IBD patients ranges from 30 to 70 %. Unlike other chronic diseases, there is currently no CD-specific tool to assess the impact of comorbidities on patients' lives in order to take appropriate medical measures. Several clinical indexes have been developed for the study of comorbidities, including the Charlson index and the Groll index, which are widely used. The disadvantage of these indexes is that they are not adapted to patients with CD. The primary objective of this study is to develop and validate a clinical index to evaluate the impact of comorbidities on disability in patients with CD.

location_country: Italy France

location_facility:
Laurent PEYRIN-BIROULET
San Raffaele Hospital


title: Evaluation of Neuropsychological Effects of Drug-resistant Anterior Temporal Epilepsy and Anterior Temporal Lobectomy in Face Perception

acronym: ATENA-F

summary:
The purpose is to evaluate neuropsychological effects of anterior temporal epilepsy in face perception by comparison of performances of epileptic patients and control individuals, sex-, age- and socio-educational level-matched.

Secondary purposes are to prospectively evaluate neuropsychological impact of anterior temporal lobectomy performed for surgical treatment of anterior temporal epilepsy on face perception (exploratory study).

primary_purpose: Other

location_facility: Service de Neurologie, Hôpital Central, CHU de Nancy

intervention_type: Procedure


title: Endoprosthesis Treatment Effects on Human Abdominal Aorta Aneurysms(AAA)Metabolic Activity

acronym: AAAendo

summary: The purpose of this study is to determine whether Positron Emission Tomography imaging can help to predict the evolutivity of AAA treated with endovascular prosthesis.

collaborators: Institut National de la Santé Et de la Recherche Médicale, France

location_facility:
Georges Pompidou European Hospital
Brabois Hospital
CH.NICOLLE's Hospital
Le Bocage - Dijon's Hospital
Institut du Thorax, Nantes's Hospital
Cardiologic Hospital
Bichat Claude Bernard Hospital


title: Development of New Prenatal Diagnostic Tests From Maternal Blood

summary: After extraction of the cell-free DNA circulating in maternal plasma, we aim at developing new techniques for fetal DNA enrichment to perform fetal gender determination, and indirect diagnosis of inherited diseases like Cystic Fibrosis, Huntington Disease, Myotonic Dystrophy, B-Thalassaemia...

status: Terminated

lead_sponsor: University Hospital, Strasbourg, France

intervention_type: Genetic


title: Role and Interactions of Adenosine, Receptors, Methionine Cycle Nutritional, Metabolic and Genetic Determinants in the Onset of Atrial Fibrillation in Normal Heart

acronym: FACS

summary:
The purpose of this study is to analyze the association of atrial fibrillation onset in normal heart and:

Genetic determinants (genes of receptors, enzymes involved in synthesis and degradation, genes of bioavailability of coenzymes and nutritional precursors)
Metabolic determinants of adenosine and methionine cycles
Nutritional determinants.

Secondary purposes are:

Analysis of physiopathologic mechanisms of AF in normal hearts and adenosine metabolisms and its interaction with methionine metabolism, according to identified genetic determinants
Analysis of blood markers of adenosine and methionine metabolites as phenotypic markers of detected polymorphisms
Evaluate the role of adenosine receptors in AF onset

primary_purpose: Basic Science

location_facility: Département de Cardiologie, CHU Nancy, Hôpitaux de Brabois


title: Impact of Using the Oncogramme® Device to Select the First Line of Treatment (Chemotherapies +/- Targeted Therapies) for Patients With Metastatic Colorectal Cancer on Progression-free Survival, Treatment Costs, Efficiency and Quality of Life Compared to Usual Patient Care.

summary:
Colorectal cancer is the 2nd leading cause of cancer death in France. Its incidence is nearly 45,000 new cases per year in 2017, with an estimated 5-year survival of 63% in 2015. Metastases are seen in 40-60% of colorectal cancer cases. The 5-year survival rate ranges from 5% to 15% for patients with widespread metastatic disease.

Two types of treatments are used to treat colon cancer: surgery and medication protocol (chemotherapeutic drugs and targeted therapies). These treatments can be used alone or in combination.

The current choice of a first line of chemotherapy is left to the practitioner's discretion, after consultation with a multidisciplinary consultation meeting. The choice of treatment(s) depends on official recommendations and is based on the results of clinical trials conducted on large populations, and takes into account the toxicities of the therapies used and the general condition of the patients. The therapeutic combinations for colorectal cancers are therefore multiple. However, to date, no consensus has been reached to ensure that each patient is treated effectively and as a unique case.

Today, functional sensitivity tests offer the possibility for patients to be offered a personalized treatment against cancer. This is the case of the Oncogramme® device developed by Oncomedics, which is the first functional sensitivity test dedicated to oncology in Europe. It is based on an in vitro analysis of each patient's tumor cells in order to compare the responses of the tumor cells to the different molecules and therapeutic combinations available (chemotherapy ± targeted therapy). This response, translated into a tumor-specific sensitivity profile, can be used by the medical team to determine the most appropriate treatment for the patient. This test is therefore likely to improve the benefit-risk ratio of a chemotherapy treatment in colorectal cancer by allowing the medical team to select, among the treatments deemed effective, the one that will be the most effective on the tumor and possibly with the least side effects.

The hypothesis of this study is that the personalization of treatments (by chemotherapy associated or not with targeted therapies) proposed by the Oncogramme®-colorectal device would allow to promote the best possible clinical response, to limit the side effects and ultimately to improve the survival and the quality of life of the patient.

design_allocation: Randomized

lead_sponsor: Oncomedics

sponsor_collaborators:
Oncomedics
Hospital St. Joseph, Marseille, France

intervention_type: Diagnostic Test

lead_sponsor_type: industriel


title: Evaluation of the Immune Response After Vaccination Against Hepatitis B in Patients With Indolent Lymphoproliferative Disorders With no Treatment.

acronym: EVACC-B

summary: The purpose of this study is to assess the seroconversion rate and the cellular immune response after vaccination against hepatitis B virus in patients with lymphoproliferative syndrome like chronic lymphocytic leukemia stade A and follicular lymphoma without of treatment criteria.


acronym: TREOCAPA

summary:
TREOCAPA is a Phase II/III European Multicentre study concerning the prophylactic treatment by Acetaminophen of extremely preterm infant during the first five days after birth.

The Phase II is a dose finding phase in order to assess the minimum effective dose regimen of acetaminophen for the closure of PDA for neonates with a gestational age less than 27 weeks This part of the study will be conducted in 11 NICUs, in 4 countries (France, UK, Finland and Denmark).

The Phase III is The phase III is a randomized, multicenter, double-blind, placebo-controlled superiority trial, two arms in a 1:1 ratio, evaluating an increasing of 10% of the percentage of survival without severe morbidity at 36 weeks of post menstrual age. In the intervention arm, 20 mg/kg followed by 7.5 mg/kg quarter in die (QID) will be administered to the 27-28 weeks gestational age group (dosage confirmed through PK/PD data analysis from the previous Finnian study) and the dosage selected after the conclusion of the Phase II will be administered to the 23-26 weeks gestational age group. A group sequential design, with a total of 3 analyses (2 interim analyses and a final) and the O'Brien-Fleming alpha spending function is chosen for the trial. At the same time, a Bayesian sequential analysis is planned for safety endpoints

sponsor_collaborators: Institut National de la Santé Et de la Recherche Médicale, France

sponsor_collaborators: PARTNERS for International clinical Research

sponsor_collaborators: European Fundation for the Care of the Newborn Infants

location_facility: CENTRE hospitalier intercommunal de Creteil

location_facility: Turku University Hospital, Department of Peadiatrics

location_facility: Tampere University Hospital, Department of Pediatrics

location_facility: Centro Hospitalar e Universitário do Porto, EPE - Centro Materno Infantil do Norte

location_facility: Azienda Ospedaliero - Universitaria delle Marche

location_facility: Kuopio University Hospital, Department of Pediatrics

location_facility: Hopital Cochin, Service de Médecine et Réanimation néonatales de Port-Royal

location_facility: Centre Hospitalier Universitaire de Liège

location_facility: Tartu University Hospital, Neonatal and Paediatric Intensive Care Unit

location_facility: Hopital Universitaire de Geneve (HUG) - Hopital des enfants

location_facility: Hospice civils de Lyon, Hopital Femme Enfant

location_facility: Helsinki University Hospital, Department of Children and Adolecents, Neonatology

location_facility: Oulu University Hospital, Department of Pediatrics

location_facility: The Juliane Marie Centre, Rigshospitalet, Copenhagen University hospital

location_facility: Centro Hospitalar Universitário Lisboa Norte, EPE -Hospital Santa Maria

location_facility: Centre Hospitalo-Universitaire de Toulouse

location_facility: Hôpital Arnaud de Villeneuve, Département de Pédiatrie Néonatale et Réanimation Pédiatrique

title: Prophylactic Treatment of the Ductus Arteriosus in Preterm Infants by Acetaminophen

type: EudraCT Number

source: euctr

location_country: Finland Ireland Italy Portugal Hungary Norway Denmark Sweden Switzerland Belgium Estonia France


title: Hémorragies et Maladie Veineuse Thromboembolique du Post-partum : Epidémiologie, Etudes Des déterminants Cliniques et Biologiques

acronym: HEMOTHEPP

summary: The aim of this study is to evaluate the frequencey and the determinants of postpartum major complications (hemorrhage and thrombosis) up to 3 months after delivery in the maternity hospitals of Finistère (Bretagne - France)

lead_sponsor: University Hospital, Brest

location_facility: CHRU de Brest - Service de Gynécologie-obstétrique


title: Early Intensification of Combination Antiretroviral Therapy Including FUZEON® in the Treatment of Progressive Multifocal Leucoencephalopathy During HIV-1 Infection ANRS 125 Trial

summary:
Progressive multifocal leucoencephalopathy (PML) is a rare infectious disease of the brain, provoked by the JC virus. It usually occurs in subjects with impaired immune system as during HIV infection. To date, there is no specific antiviral treatment susceptible to cure PML. But it was shown in the setting of HIV-related PML, that combination antiretroviral therapy allows a restoration of the immune system and then might stop the progression of PML.

The objective of this study is to appreciate the supplementary efficiency brought by an association of more powerful antiretroviral molecules including enfuvirtide on the evolution of PML. This research program will involve 30 patients in several centres in France. All the patients who will participate will receive enfuvirtide during 6 months in association with a combination of two or more potent antiretroviral drugs. The total duration of follow-up for a patient will be of 1 year.

ReferenceType: derived

ReferenceCitation: Gasnault J, Costagliola D, Hendel-Chavez H, Dulioust A, Pakianather S, Mazet AA, de Goer de Herve MG, Lancar R, Lascaux AS, Porte L, Delfraissy JF, Taoufik Y; ANRS 125 Trial Team. Improved survival of HIV-1-infected patients with progressive multifocal leukoencephalopathy receiving early 5-drug combination antiretroviral therapy. PLoS One. 2011;6(6):e20967. doi: 10.1371/journal.pone.0020967. Epub 2011 Jun 30.

lead_sponsor: French National Agency for Research on AIDS and Viral Hepatitis

collaborators:
Hoffmann-La Roche
Gilead Sciences

location_facility: Service de Medecine interne et Maladies Infectieuses, Hopital Bicetre


title: Multicentric, National, Prospective, Comparative, Non Randomized Study, Assessing Medico-economic Impact of Three Strategies of Sentinel Lymph Node Analysis in Immediately Operable Breast Cancer

acronym: SAGE

summary:
Breast carcinoma requires frequently an adjuvant therapy after surgical excision: in this way, one of the major criteria indicating the need of adjuvant chemotherapy is the diagnosis of a metastatic lymph-node invasion, mainly in the axillary field. Axillary surgery is therefore mandatory at the diagnosis of breast carcinoma. For many years, in order to avoid unnecessary complications due to extensive axillary surgery (for instance, arm enlargement by lymphedema), a limited surgery is frequently performed on the first supposed invaded lymph-nodes (LN) called "sentinel" LN technique; if the sentinel LN are not invaded, extensive axillary surgery can be omitted. To decide it during the surgery, removed sentinel LN are cut in 3 to 4 slices which are examined immediately as smears (cytology) or frozen slices (pathology). However, due to hazard in cutting the LN, micro-metastases can be misdiagnosed. That is why a recent molecular biology method has been developed in which the total LN are crushed and blended, then analyzed by OSNA technique (One Step Nuclear Acid analysis) so as to amplify and detect the mRNA coding for cytokeratin-19 protein witnessing the LN metastatic invasion. A standardized automated technique is available with a mean time of 30 to 50 minutes according to the number of analyzed LN.

In 12 international studies (2830 cases) the consistency between OSNA technique and final pathology is of 91 to 98% and the sensitivity seems higher. Less than 5% of all breast carcinomas cells don't express CK-19 protein.

The use of OSNA technique requires a dedicated machine and a skilled pathologist, increasing slightly the operation time; however it allows to avoid the immediate and long-term complications due to the radical LN axillary surgery in case of negativity of the sentinel LN procedure. To date, the three techniques including extemporaneous examinations (OSNA or classical methods) or not (classical pathological analysis) have their own advantages and drawbacks.

"SAGE" study main objective is to compare these three techniques in terms of direct costs and Quality of Life impacts. The superiority of any of these three techniques is not the purpose of SAGE study, but the economic burden of OSNA technique in comparison with the 2 others in the standard setting in France.

Quality of Life and Pain evaluations will be performed immediately after surgery and during the 6 months after.

lead_sponsor: Institut Cancerologie de l'Ouest

location_facility:
HEGP
Jean-Marc cancérologie CLASSE
Institut Bergonie
CHU
ICO Paul Papin
Jean Perrin
Oscar Lambret
Institut du Sein -Clinique Saint-Amé
Clinique Mutualiste
Institut de Cancérlogie de Lorraine
Eugène Marquis
IUCT-O
Henri BECQUEREL
Institut Paoli Calmettes
Institut Curie


title: Clinical Evaluation of URGOSTART PLUS® BORDER, URGOSTART PLUS® PAD and URGOSTART INTERFACE® in the Local Treatment of Diabetic Foot Ulcers and Venous Leg Ulcer of Mixed Etiology : French Prospective and Multicentric Observational Study

acronym: STARTLIFE

summary: The objective of this study is to document the performance and the safety of UrgoStart Plus® Border, UrgoStart Plus® Pad and UrgoStart Interface® in the local treatment of diabetic foot ulcers (neuropathic or neuroischemic - non-critical ischemia) and venous or mixed predominantly venous leg ulcers, in real life conditions and current practice, in France.

lead_sponsor: Laboratoires URGO

intervention_type: Device


title: Assessment of Adults Epidemiological Characteristics of Status Epilepticus in the French West Indies and in French Guiana

acronym: EpiDFA

summary:
The justification of this prospective and multicenter study is based on the absence of published data concerning, status epilepticus (SE), a pathology which seems frequent in the French West Indies (FWI) and French Guiana, and whose etiological and prognostic characteristics are often mentioned or assumed but which remain to be demonstrated. The scientific interest lies both in the knowledge of the epidemiology of this pathology and in the identification of the main etiologies, in particular the underlying brain lesions.

The morbidity of SE is significant, associating neurological disorders with impaired consciousness, respiratory, hemodynamic and cardiac rhythm disorders, as well as metabolic disorders such as acidosis. SE-related mortality in the acute phase ranges from 3-40% across studies and regions, while long-term mortality ranges from 17-80% depending on age, cause of SE, comorbidities and the occurrence of complications.

The prognosis of this pathology has however improved in recent years in developed countries or countries with a high level of health system. On the other hand, the morbidity and mortality of SE in the French overseas departments is not known, even if these territories are supposed to be at an equivalent level in terms of health system to that of mainland France.

lead_sponsor: University Hospital Center of Martinique

location_facility: University Hospital Center of Guadeloupe


title: AVENANCE - A Non-interventional Study to Provide Real-world Data on the Use of Avelumab as a Maintenance Treatment for Patients With Advanced or Metastatic Urothelial Carcinoma

acronym: AVENANCE

summary: A multicenter ambispective (retrospective and prospective) non-interventional study of patients with locally advanced or metastatic urothelial carcinoma (adv/mUC) treated with avelumab in France, not impacting the treatment decision made by the treating physician and the medical management of treated patients.

ipd_sharing_description: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.

lead_sponsor: Pfizer

sponsor_collaborators:
Pfizer
Merck KGaA, Darmstadt, Germany

location_facility: ICANS - Institut de cancerologie Strasbourg Europe

location_facility: Groupe Hospitalier Mutualiste de Grenoble Institut Daniel Hollard

location_facility: Polyclinique de LIMOGE-Clinique François CHENIEUX

location_facility: Institut de Cancérologie Lucien Neuwirth

location_facility: Centre Hospitalier Universitaire Gabriel Montpied

location_facility: Centre de Lutte Contre Le Cancer - Auvergne Jean Perrin

location_facility: Centre Hospitalier Universitaire de Montpellier

location_facility: Groupe Hospitalier La Rochelle - Re - Aunis

location_facility: Centre Hospitalier Intercommunal Louviers

location_facility: Centre Hospitalier Intercommunal de Creteil

location_facility: Centre Hospitalier Regional Universitaire de Brest

location_facility: La Roche Sur Yon - Centre Hospitalier Departemetal Vendee

location_facility: Groupe Hospitalier Diaconesse La Croix Saint Simon


title: Impact of Yogotherapeutics in Consultation on Chronic Pains' Patients

acronym: YOGADO

summary: In a context where yoga is more and more popularized in France and in Europe, and where Yogatherapy (as complementary medicine) begins to make its place in the care of patients in French hospitals, it seems interesting to study the impact of yoga in the chronic pain patient treated in a specific pain consultation by this non-pharmacological approach, and accessible.

time_perspective: Retrospective

lead_sponsor: Hôpital NOVO

location_facility: Departement of Chronic Pain Consultation, Hospital René Dubos,


title: Randomized, Cross-over Study Comparing the Efficacy of the 3C60 Knee Against Non-microprocessor Controlled Knees on the Risk of Falling and Locomotor Skills of Moderately Active Persons With Leg Amputation Above Knee or Knee Disarticulation

summary:
Moderately active amputees may have lost their limb due to diabetes, vascular conditions, trauma, tumour or congenital causes. These amputees currently cannot benefit from having a computerised knee because of the performance criteria associated with being given one. However, these amputees have a very high risk of falling because they use a non microprocessor controlled knee joint (NMPK) and because their physical ability, associated disability and persistent contralateral leg weakness do not allow them to compensate for a balance deficit. These amputees restrict how much they move around and their participation because of their instability and elevated risk of falling.

The objective of the study is to evaluate the effect of the 3C60 knee, a microprocessor-controlled knee joint for external leg prosthesis, on the reduction in the risk of falling after three months in moderately active persons with leg amputation above knee or knee disarticulation.

ReferenceType: background

ReferenceCitation: Schoppen T, Boonstra A, Groothoff JW, de Vries J, Goeken LN, Eisma WH. The Timed "up and go" test: reliability and validity in persons with unilateral lower limb amputation. Arch Phys Med Rehabil. 1999 Jul;80(7):825-8. doi: 10.1016/s0003-9993(99)90234-4.

ReferenceCitation: Dite W, Connor HJ, Curtis HC. Clinical identification of multiple fall risk early after unilateral transtibial amputation. Arch Phys Med Rehabil. 2007 Jan;88(1):109-14. doi: 10.1016/j.apmr.2006.10.015.

ReferenceCitation: Franchignoni F, Orlandini D, Ferriero G, Moscato TA. Reliability, validity, and responsiveness of the locomotor capabilities index in adults with lower-limb amputation undergoing prosthetic training. Arch Phys Med Rehabil. 2004 May;85(5):743-8. doi: 10.1016/j.apmr.2003.06.010.

ReferenceCitation: Gauthier-Gagnon C, Grise MC, Potvin D. Enabling factors related to prosthetic use by people with transtibial and transfemoral amputation. Arch Phys Med Rehabil. 1999 Jun;80(6):706-13. doi: 10.1016/s0003-9993(99)90177-6.

ReferenceCitation: Burnfield JM, Eberly VJ, Gronely JK, Perry J, Yule WJ, Mulroy SJ. Impact of stance phase microprocessor-controlled knee prosthesis on ramp negotiation and community walking function in K2 level transfemoral amputees. Prosthet Orthot Int. 2012 Mar;36(1):95-104. doi: 10.1177/0309364611431611. Epub 2012 Jan 5.

ReferenceCitation: Gauthier-Gagnon, C, grisé, MCL, Lepage Y. The Locomotor Capabilities Index : Content validity. J rehabil OutcomesMeas 2(4) : 40-46, 1998.

ReferenceCitation: Gauthier-Gagnon, C, Grisé, MCL, Potvin, L. Predisposing factors related to prosthetic use by people with a transtibial and transfemoral amputation. J Prosthet Orthot 10: 99-109, 1998

ReferenceCitation: Gauthier-Gagnon C, Grise MC. Prosthetic profile of the amputee questionnaire: validity and reliability. Arch Phys Med Rehabil. 1994 Dec;75(12):1309-14.

ReferenceCitation: Grise MC, Gauthier-Gagnon C, Martineau GG. Prosthetic profile of people with lower extremity amputation: conception and design of a follow-up questionnaire. Arch Phys Med Rehabil. 1993 Aug;74(8):862-70. doi: 10.1016/0003-9993(93)90014-2.

ReferenceCitation: Demers L, Weiss-Lambrou R, Ska B. Development of the Quebec User Evaluation of Satisfaction with assistive Technology (QUEST). Assist Technol. 1996;8(1):3-13. doi: 10.1080/10400435.1996.10132268.

ReferenceCitation: Leplege A, Mesbah M, Marquis P. [Preliminary analysis of the psychometric properties of the French version of an international questionnaire measuring the quality of life: the MOS SF-36 (version 1.1)]. Rev Epidemiol Sante Publique. 1995;43(4):371-9. French.

ReferenceCitation: Leplège, A. (2001). Introduction, enjeux, définitions. In J. Coste et A. Leplège (Eds.), Mesure de la santé perceptuelle et de la qualité de vie : méthodes et applications (pp 15-36). Paris : Editions Estem

ReferenceCitation: Ware JE, Snow KK, Kosinski M, Gandek B (1993). Health survey : manual and interpretation guide. Boston, Massachussets : The Health Institute, New England Medical Center, 1993

ReferenceCitation: Ware JE Jr, Sherbourne CD. The MOS 36-item short-form health survey (SF-36). I. Conceptual framework and item selection. Med Care. 1992 Jun;30(6):473-83.

ReferenceCitation: Loiret I, Paysant J, Martinet N, Andre JM. [Evaluation of amputees]. Ann Readapt Med Phys. 2005 Jul;48(6):307-16. doi: 10.1016/j.annrmp.2005.03.009. Epub 2005 Apr 15. French.

lead_sponsor: Otto Bock France SNC

location_country: Germany Austria France

location_facility: Institut Régional de Médecine Physique et de Réadaptation

location_facility: Centre Hospitalier de Cornouaille Concarneau


acronym: PROM SSCOL

lead_sponsor: Centre Hospitalier Universitaire de la Réunion

summary:
Cervical cancer (CCU) is the fourth most common cancer in women worldwide. In Reunion island, CCU is the third leading cause of cancer in women (standardized incidence rate on the world population (TIS) in 2013 of 10.3 / 100,000) and is the eighth deadliest cancer with a rate standardized mortality of 4.8 / 100,000, almost three times higher than in mainland France where it was 1.7 / 100,000 in 2018.

CCU results from infection with the human papillomavirus (HPV), which is the most common sexually transmitted viral infection.

CCU prevention is mainly based on cervical smear screening and anti HPV vaccination (VHPV) which has demonstrated its effectiveness on the prevalence of HPV carriage, but also on incidence of condyloma or intermediate grade dysplasia. Since HPV is mainly transmitted sexually, it is important to vaccinate before the start of sex.

In Reunion island, the HPV vaccination coverage rate is the lowest in France, estimated by Public Health France at 8.1% among girls aged 16 years in 2018, while the already low national average was established 23.7%.

Thus, in view of the epidemiological situation in Reunion island (high incidence and mortality for the CCU, very low VHPV coverage rate), we thought it would be interesting to study the impact of a health promotion program sex and prevention of sexually transmitted infections (STIs) including papillomavirus-related pathologies, with a program to promote HPV vaccination among young students in middle school.

ReferenceCitation: Tran PL, Chirpaz E, Boukerrou M, Bertolotti A. Impact of a Papillomavirus Vaccination Promotion Program in Middle School: Study Protocol for a Cluster Controlled Trial. JMIR Res Protoc. 2022 Jun 13;11(6):e35695. doi: 10.2196/35695.

oa_colors: green gold

oa_host_type: publisher;repository

evidence: oa journal (via doaj)

host_type: publisher

license: cc-by

license_normalized: cc-by

version: publishedVersion

evidence: oa repository (via pmcid lookup)

host_type: repository

license_normalized: no license

repository_normalized: PubMed Central

repositories_concat: PubMed Central

unpaywall_oa_status: gold

publisher_dissemination: JMIR Publications

title: Study of the Impact of a School Program Combining - Promotion of HPV Vaccination and HPV Vaccine Offer in Middle School - on Adherence to HPV Vaccination in Middle School Students


title: Effectiveness and Cost Of ICD Follow-up Schedule With Telecardiology

acronym: ECOST

summary: In many aspects of every-day life, modern communication systems bring about a remarkable increase in comfort and safety by transmitting data and information in an easy and reliable manner. In order to provide these advantages also to patients with implantable cardioverter-defibrillators, as well as to their physicians, BIOTRONIK has developed a long-distance implant telemetry to enable periodic trend and event-triggered transmissions of implant data and intracardiac electrogram over distances of several meters. The data is received by a patient device and subsequently automatically transferred to a BIOTRONIK Service Center that provides it to the physician on a password secured internet site. Hence, the physician receives diagnostic information without the patient having to visit the physician (Home Monitoring, HM). New possibilities will arise for a detailed medical and event-correlated supervision of the patient's therapy using electrically active implants.

ReferenceCitation: Guedon-Moreau L, Lacroix D, Sadoul N, Clementy J, Kouakam C, Hermida JS, Aliot E, Kacet S; ECOST trial Investigators. Costs of remote monitoring vs. ambulatory follow-ups of implanted cardioverter defibrillators in the randomized ECOST study. Europace. 2014 Aug;16(8):1181-8. doi: 10.1093/europace/euu012. Epub 2014 Mar 9.

oa_colors: green hybrid

evidence: open (via crossref license)

license: cc-by-nc

license_normalized: cc-by-nc

evidence: oa repository (via OAI-PMH doi match)

repository_institution: PubMed Central - Europe PMC

evidence: oa repository (semantic scholar lookup)

version: submittedVersion

repositories_concat: PubMed Central;pdfs.semanticscholar.org

unpaywall_oa_status: hybrid

publisher_dissemination: Oxford University Press

ReferenceCitation: Guedon-Moreau L, Kouakam C, Klug D, Marquie C, Brigadeau F, Boule S, Blangy H, Lacroix D, Clementy J, Sadoul N, Kacet S. Decreased delivery of inappropriate shocks achieved by remote monitoring of ICD: a substudy of the ECOST trial. J Cardiovasc Electrophysiol. 2014 Jul;25(7):763-70. doi: 10.1111/jce.12405. Epub 2014 Apr 10.

oa_host_type: closed

repositories_concat: closed

publisher_dissemination: Wiley

ReferenceCitation: Guedon-Moreau L, Lacroix D, Sadoul N, Clementy J, Kouakam C, Hermida JS, Aliot E, Boursier M, Bizeau O, Kacet S; ECOST trial Investigators. A randomized study of remote follow-up of implantable cardioverter defibrillators: safety and efficacy report of the ECOST trial. Eur Heart J. 2013 Feb;34(8):605-14. doi: 10.1093/eurheartj/ehs425. Epub 2012 Dec 13.

lead_sponsor: Biotronik SE & Co. KG


title: Observational Study of the Impact of the COronaVirus Disease 2019 (COVID-19) Epidemic on Patients With Myeloproliferative Neoplasias

acronym: COVIM

summary: The classic myeloproliferative neoplasias (MNP), including polycythemia vera (PV), essential thrombocythemia (ET), primary myelofibrosis (PMF) or secondary to PV or ET, are among the most frequent of malignant hemopathies, with overall prevalence estimated at around 10,000 patients followed in France. Due to the median age of patients around 65, the frequency of cardiovascular complications of these thrombogenic diseases and the impact of cytoreductive treatments on immune cells, these patients are considered to be at risk of developing forms severe of COVID-19. This study will assess the impact of MNPs on the risk of developing a severe form of COVID-19, identify new risk factors linked to the disease as well as the impact of treatments for MNPs according to their pharmacological class.

lead_sponsor: French Innovative Leukemia Organisation

collaborators: French Intergroup of Myeloproliferative syndromes


title: Cognitive Sequels of Cushing Syndrome

acronym: MEMOCUSH

summary: Cushing's disease is a state of chronic endogenous glucocorticoid excess. Cushing's disease is responsible for increased morbidity and mortality. Recent studies have pinpointed the frequency of somatic sequelas and persistent alteration in quality of life despite the cure of the disease. More specifically, a few studies have described persistent psychopathology, maladaptive personality and cognitive impairments in patients with a history of Cushing's disease. Among these, hippocampal memory deficits have been found in the majority of studies, a finding that is consistent with the alterations described in hippocampal neurons during chronic exposure to glucocorticoids. However, the tools currently available to assess hippocampal-dependent memory are multiple, sometimes difficult to perform by clinicians and to analyze or may lack of diagnostic sensitivity. The investigators have recently developed an original tool, the virtual radial task in 3D, which has shown to be reliable to detect subtle alterations in hippocampal-dependent memory in several human diseases. The primary aim of the study is the evaluation of persistent cognitive impairments (hippocampal memory) in patients cured of Cushing's disease for at least one year using the virtual radial task in 3D and to compare it with that obtained with classical cognitive tests.

ReferenceCitation: Pupier E, Santos A, Etchamendy N, Lavielle A, Ferriere A, Marighetto A, Resmini E, Cota D, Webb SM, Tabarin A. Impaired quality of life, but not cognition, is linked to a history of chronic hypercortisolism in patients with Cushing's disease in remission. Front Endocrinol (Lausanne). 2022 Aug 8;13:934347. doi: 10.3389/fendo.2022.934347. eCollection 2022.

repository_institution: Universitat Autònoma de Barcelona - Dipòsit Digital de Documents de la UAB

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Université Paris Descartes

repository_normalized: HAL

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - memSIC

repository_institution: Universite de Bordeaux - Oskar-Bordeaux

publisher_dissemination: Frontiers


title: Monitoring of JOB STRESS Related to Night Shifts in OPHthalmology Physicians and Residents

acronym: JOBSTRESS-OPH

summary:
Ophthalmology physicians and residents work under stress conditions during night emergency ophthalmology shifts. Under time pressure, that is a characteristic of the urgency of care, they must use all their cognitive resources to make an accurate diagnosis and to provide accurate decisions, with sometimes surgical emergency acts. In addition, in France, they work at night following by an usual day work, and they can also work 48 consecutive hours during weekends, followed by a work day … i.e. 60 consecutive hours of work … Long working hours with a short recovery time has been demonstrated to be a major factor of stress and fatigue. Even if not demonstrated on ophthalmologists, those working conditions may contribute to symptoms of mental exhaustion and physical fatigue (sleep deprivation), often accompanied by a loss of motivation at work. This may leads to a feeling of loss of time control; stress can also distort the perception of time and leads to hasty actions or delayed decision-making. The combined effects of stress, feelings of loss of time control, and fatigue necessarily have an impact on work performance and work quality, with a high risk of medical error. Moreover, prolonged stress may expose ophthalmologists to a higher risk of multiple diseases, predominantly systemic inflammation and coronary heart disease.

The main hypothesis is that prolonged work (up to 60 consecutive working hours) may impact on HRV, comparatively to a typical working day.

primary_purpose: Screening

lead_sponsor: University Hospital, Clermont-Ferrand

collaborators: University Clermont Auvergne (UCA), Clermont-Ferrand, France

collaborators: LaPSCO laboratory, UMR CNRS 6024, Clermont-Ferrand, France


title: Elderly CAncer Patient: Qualitative and Quantitative Factors of Inclusion Failure in Clinical Trials

acronym: Quali-SAGE

summary:
The transposition of the results of biomedical research to medical management of patients in real-life setting depends highly from patient's selection. In Europe and the United States, the majority of cancers occur after 65 years. In France, 45% of cancers diagnosed in 2012 were after 70 years or 158,722 in absolute value. In this context, the median age at diagnosis was 72 years old. Disease particularly affecting the elderly, cancer is also characterized by the importance of biomedical research devoted to it. Despite the dynamism of the research activity in oncology and therefore the number of affected patients, the elderly are paradoxically sparsely included in clinical trials. Numerous studies have focused in recent years, to identify possible causes of under-representation of elderly patients in clinical trials but most of them focused on eligibility criteria and few on barriers related to non-invitation or non-inclusion in eligible patients.

The investigator postulate that a qualitative survey based on an structured epidemiological device will able to objective evidences of reasons related to the patient, participant familial caregivers, participant physician and the clinical center organization for participating or not to a clinical trial and the interrelations between the identified reasons.

The main objective is to assess reasons of non-participation of older patients with cancer in clinical trials, from the physicians, patients and family caregivers' perspectives using qualitative and quantitative methods.

The secondary objectives are:

To investigate the social representation and construction of being "aged" from the patient, physician and family caregiver perspective (qualitative part).

To compare the reasons of non-participation regarding age class (old and very old), localized versus metastatic disease and tumor site (quantitative part).

To characterize the profiles of participants and non-participants to clinical trial among older patients with cancer thanks to qualitative and quantitative data.

Method Quali SAGE is a French, socio-epidemiologic, multicenter prospective study that includes patients aged 70 years or over, with solid tumor (irrespective of the stage) in French hospitals.

lead_sponsor: Assistance Publique - Hôpitaux de Paris

sponsor_collaborators:
Assistance Publique - Hôpitaux de Paris
National Cancer Institute, France


title: Physical Activity Experiment on Male Prostate Cancer Patients : Feasibility Multicenter Study of an Innovative Follow-up by Peers

summary: Prostate cancer is the most common cancer in France (56,841 cases in 2012). Although the benefits of physical activity (PA) in cancer patients are currently well established in the scientific literature, several studies have shown that this population is not sufficiently active. Strengthen patient adherence to prevention counseling by the physical activity (PA) is emerging as a new challenge for personalized treatment in oncology. In order to encourage the engagement and maintenance in a regular PA of cancer patients, first, their experiences of physical activity (PA) practice should be considered and their initial social representations of the practice considered. Secondarily, it is also important to identify health professionals who retain a key role in defining the framework, objectives and means of action to promote lifestyle changes towards a more active lifestyle. In addition, peer mentoring appears to offer promising perspectives for promoting adherence and long-term maintenance in physical activity (PA) of cancer patients.

primary_purpose: Supportive Care

lead_sponsor: Centre Hospitalier Universitaire de Saint Etienne

location_facility:
ICLN - Oncologie médicale
CHU Saint-Etienne
ICLN - département de radiothérapie


title: A Pilot Study to Evaluate the Safety of a 3 Weeks Sitagliptin Treatment in HCC Patients Undergoing Liver Resection

acronym: HCC-DPPIV

summary: Boosting of tumor cell killing by cytotoxic lymphocytes may be a promising means to enhance anti-tumor immunity. Prior studies demonstrated that tumor infiltration by cytotoxic lymphocytes correlates with control of tumor growth and is associated with an improved prognosis in cancer patients. Trafficking of activated lymphocytes is a tightly regulated mechanism and the specific nature of the chemokine milieu is a crucial determinant for permitting T cell entry into the tumor microenvironment. CXCL10 is an interferon-inducible chemokine particularly important for the recruitment of activated T, and it has been shown to enhance anti-tumor responses through its action on cytotoxic T cells (e.g., glioblastoma, colorectal adenocarcinoma and lung carcinoma). Additionally, roles for CXCL10 as an anti-tumor effector include its ability to chemo-attract NK cells into sites of inflammation, and its ability to inhibit development of new vasculature and induce the regression of newly formed vessels. Adding a layer of complexity, the function of CXCL10 can be regulated by dipeptidylpeptidase IV (DPPIV), leading to the formation of a dominant negative, antagonist form of the chemokine. This was initially demonstrated in vitro, and recent work has provided convincing in vivo evidence that antagonist forms of CXCL10 regulate lymphocyte trafficking. The main goal of this protocol is to evaluate the tolerance of sitagliptin treatment in HCC patients, and secondary DPPIV inhibitors as a strategy for protecting CXCL10 chemokine agonist activity as a means to enhance tumor regression.

lead_sponsor: Institut National de la Santé Et de la Recherche Médicale, France


title: Developing Derived Induced Pluripotent Stem Cells From Blood as a Model for the Study to Understand Imprinted Disorders

acronym: ID-STEM

summary:
Fetal and postnatal growth is finely regulated by genetic, epigenetic and environmental mechanisms. Parental imprinting is a regulatory mechanism that allows monoallelic expression of certain genes from a single parental allele through differential DNA methylation. Imprinted genes play a very important role in the control of fetal and postnatal growth. The pathophysiological mechanisms of these epimutations are largely unknown.

Studying the consequences of these epimutations on the molecular signature of the imprinted gene network in these patients would provide a better understanding of the epigenetic mechanisms regulating fetal growth. As these genes are weakly expressed in fibroblasts, these studies will be carried out on pluripotent stem cells or IPSCs (Induced Pluripotent Stem Cells).

status: Enrolling by invitation

ipd_sharing: Yes

ipd_sharing_description: IPD will be sahred with partners

lead_sponsor: Institute of Cardiometabolism and Nutrition, France


title: The French Multiple Sclerosis Registry

acronym: OFSEP

summary:
OFSEP is an observational cohort of Multiple Sclerosis (MS) and related disorders set up in France. It aims to provide a major epidemiological tool on MS for the scientific community in France and abroad. This tool must help to answer a large number of questions concerning the causes and mechanisms of MS, the prognostic factors of disease progression, the effectiveness and safety of therapeutic drugs, the impact of the disease on patients and society, etc.

In December 2015, it has already included more than 54.000 patients. To achieve this goal, OFSEP's objectives are

To maintain and develop the French cohort of patients suffering from MS or related diseases and syndromes. This means collecting standardized socio-demographic and clinical data as part of the routine medical follow-up of patients already in the cohort and recruitment of new patients.
To supplement the existing clinical data with standardized and quality biological samples and MRI scans.
To improve the previous data with medical/administrative data from the health insurance fund databases in particular, in order to get more information on comorbidity, treatment protocols and the medico-economic aspects of this disease.
To use OFSEP infrastructures to facilitate the implementation of specific studies requiring the collection of additional data or specific patient monitoring processes.
To ensure the availability of these data and samples to researchers, health care authorities and industrial players to enable analysis and thus provide answers to research questions or public health issues. This availability is only possible after scientific and regulatory evaluation of the request.
To provide regular descriptions of the patient population in the cohort to offer statistics, targets and up-to-date information on this disease and thus enable a better approach to the personal, professional and social impacts of the illness, the effects of basic treatments and the requirements related to the follow-up of this disease in France.
To conduct specific studies on the entire population of patients in the cohort (parent cohort) or on patient sub-groups with specific characteristics (nested cohorts). Four nested cohorts have been defined: patients with radiologically isolated syndromes, patients with clinically isolated syndromes, patients with primary progressive courses of the disease and patients with neuromyelitis optica (Devic's syndrome) spectrum disorders.

lead_sponsor: Hospices Civils de Lyon

location_facility: Hospices Civils de Lyon / Hopital Neurologique Pierre Wertheimer


title: Optimized Rehabilitation After Anterior Cruciate Ligament Reconstruction at the First Step of Return to Sport

acronym: ORACL-Run

summary:
Following reconstruction of the anterior cruciate ligament (ACL), a standardized rehabilitation protocol is carried out by a physiotherapist. In France, a well-established rehabilitation consensus guides the first phase of 3 months postoperatively and patient compliance is generally excellent. The next phase should allow a return to sport (RTS) following a continuum depending on the objectives of the sport's patient, starting with a return to running activities (RTR) and a preparatory phase for a RTS which may be authorized at 6 months post-op.

This multicentre randomized control trial aims to evaluate the effectiveness of an individualized and optimized rehabilitation program guided by monthly assessments carried out by physiotherapists from the 3rd to the 6th month postoperatively to reduce the risk of new ACL injuries (operated or healthy knee), compared to standard management.

sponsor_collaborators: Centre Hospitalier Universitaire de Saint Etienne

location_country: Switzerland France

location_facility:
CHU de Saint-Etienne
Clinique de La Sauvegarde
Centre Hospitalier de Firminy
Clinique de Domont Ortholab
Hopital de La Croix Rousse
Medipole de Savoie
Hôpital de la Tour

appel_a_projets: PHRIP

region: Auvergne-Rhône-Alpes

nom_etablissement: CHU DE SAINT-ETIENNE

type_etablissement: CH

acronyme: ORACL-Run

titre: OPTIMISATION DE LA REEDUCATION APRES RECONSTRUCTION DU LIGAMENT CROISE ANTERIEUR DANS LA PREMIERE PHASE DE RETOUR AU SPORT.

discipline_principale: orthopédie / traumatologie

nom_porteur: Rambaud

prenom_porteur: Alexandre


title: Artificial Intelligence Use for the Detection of Atrial Fibrillation Drivers

acronym: AI Fib

summary: pilot clinical study, multicenter, prospective, open, nonrandomized

status: Withdrawn

lead_sponsor: Hospital St. Joseph, Marseille, France

location_country: Netherlands France

location_facility:
Isala Hospital
Hopital d'Aix en Provence
CHU Nice


title: Impact of a Consultation Between a Coordinating Physician and a Referring Physician About the Optimization of Drug Prescription for Each Resident Entering in Nursing Home (EHPAD).

acronym: OPTIM-EHPAD

summary:
Elderly people are at high risk of multiple medication which increases drug interactions and side effects. This problem is accentuated in EHPAD due to the multiplication of prescribers (the referring physician, the hospital physician, the specialist, the emergency physician, the coordinating physician). The lack of optimization of drug prescriptions in EHPAD can be responsible for iatrogenic, underuse and overuse of treatment, impacting the autonomy and quality of life of residents in EHPAD in France.

A method for optimizing diagnostic and drug management at the entry of a new EHPAD resident, called OPTIM EHPAD, has been tested in Languedoc-Roussillon (France) and validated. This is a consultation between the referring physician and the EHPAD coordinating physician. Some improvements have been made to this method in order to have an optimized version.

Physician's cooperation seems to promote decision-making and change in therapies. The objective of this study is to assess the theoretical effectiveness and efficiency of this approach.

It is supposed that the provision to the EHPAD coordinating physician of a method for optimizing the diagnostic and drug management of the new EHPAD resident (based on a decision following consultation between the referring doctor and the coordinating doctor) would impact on the resident care process, on their care results and on communication and coordination between the coordinating physician and the referring physician.


title: Diagnostic Accuracy of the Circulating Cell-free DNA-based Epigenetic Biomarker mSEPT9 for Hepatocellular Carcinoma Detection Among Cirrhotic Patients: the SEPT9-CROSS Study

summary: Prospective evaluation of the circulating cell-free DNA-based epigenetic biomarker (mSEPT9) through a cross-sectional biomarker phase II design. The aim of the SEPT9-CROSS study is to assess the diagnostic accuracy of the plasma mSEPT9 biomarker in a large-scale study of 530 cirrhotic patients recruited in the Nancy University Hospital.

ipd_sharing_description: Final report, publication in a peer review journal. Main data and supplemental data.

lead_sponsor: Central Hospital, Nancy, France

collaborators: Groupement Interrégional de Recherche Clinique et d'Innovation

location_facility: University Hospital of Nancy (CHRU de Nancy)

appel_a_projets: PHRCI

region: Grand Est

nom_etablissement: CHRU DE NANCY

titre: Évaluation du marqueur épigénétique circulant mSEPT9 dans la prédiction de survenue du carcinome hépatocellulaire chez le patient cirrhotique : essai prospectif multicentrique

discipline_principale: prévention en santé

nom_porteur: OUSSALAH

prenom_porteur: Abderrahim


title: Impact of Covid-19 in Congenital Heart Disease - COVID-CHD

acronym: COVID-CHD

summary:
The ongoing Coronavirus (Covid-19) pandemic has recently generated the first epidemiological data on populations at risk. Currently, the risk factors, recognized for severe forms of Covid-19 infection, are elderly patients (> 70 years), obese patients, patients with chronic renal or respiratory diseases, cardiovascular history (stroke or coronary artery disease), high blood pressure, diabetes, and cancer.

The population of congenital heart disease (CHD) might also be at risk, however, no data is available in this group of patients.

CHD is the leading cause of birth defects, and as a result of recent medical advances, currently the number of adults with CHD exceeds the number of children, with an increasing prevalence of complex CHD. Approximately 200,000 children and 250,000 adults are living with a CHD in France today.

The French Society of Cardiology, coordinator of this study, issued recommendations on March 14, 2020 for the French CHD population on the basis of expert opinions based essentially on the data published in the general population. Nevertheless, there is a need to provide scientific data on the impact of Covid-19 in the pediatric and adult CHD population.

This study aims to assess the morbidity, the mortality and the risk factors associated with Covid-19 in patients with CHD in France

ReferenceCitation: Marelli AJ, Mackie AS, Ionescu-Ittu R, Rahme E, Pilote L. Congenital heart disease in the general population: changing prevalence and age distribution. Circulation. 2007 Jan 16;115(2):163-72. doi: 10.1161/CIRCULATIONAHA.106.627224. Epub 2007 Jan 8.

ReferenceCitation: Wu Z, McGoogan JM. Characteristics of and Important Lessons From the Coronavirus Disease 2019 (COVID-19) Outbreak in China: Summary of a Report of 72 314 Cases From the Chinese Center for Disease Control and Prevention. JAMA. 2020 Apr 7;323(13):1239-1242. doi: 10.1001/jama.2020.2648. No abstract available.

publisher_dissemination: American Medical Association

ReferenceCitation: Zhou F, Yu T, Du R, Fan G, Liu Y, Liu Z, Xiang J, Wang Y, Song B, Gu X, Guan L, Wei Y, Li H, Wu X, Xu J, Tu S, Zhang Y, Chen H, Cao B. Clinical course and risk factors for mortality of adult inpatients with COVID-19 in Wuhan, China: a retrospective cohort study. Lancet. 2020 Mar 28;395(10229):1054-1062. doi: 10.1016/S0140-6736(20)30566-3. Epub 2020 Mar 11. Erratum In: Lancet. 2020 Mar 28;395(10229):1038. Lancet. 2020 Mar 28;395(10229):1038.

oa_colors: green other

evidence: open (via free pdf)

unpaywall_oa_status: bronze

publisher_dissemination: Elsevier

ReferenceCitation: Wu C, Chen X, Cai Y, Xia J, Zhou X, Xu S, Huang H, Zhang L, Zhou X, Du C, Zhang Y, Song J, Wang S, Chao Y, Yang Z, Xu J, Zhou X, Chen D, Xiong W, Xu L, Zhou F, Jiang J, Bai C, Zheng J, Song Y. Risk Factors Associated With Acute Respiratory Distress Syndrome and Death in Patients With Coronavirus Disease 2019 Pneumonia in Wuhan, China. JAMA Intern Med. 2020 Jul 1;180(7):934-943. doi: 10.1001/jamainternmed.2020.0994. Erratum In: JAMA Intern Med. 2020 Jul 1;180(7):1031.

ipd_sharing: Undecided

ipd_sharing_description: NC

lead_sponsor: University Hospital, Montpellier

collaborators: Pr. Jean-Benoît THAMBO, Bordeaux (président)

collaborators: Dr. Céline GRUNENWALD GRONIER, Strasbourg

collaborators: Dr. Sébastien HASCOET, Le Plessis-Robinson


title: Study of Osteoconduction Potential of an Injectable Calcium Phosphate in Orthopaedic Surgery in Fillings of Osseous Defects From Various Origins

summary: The purpose of this non-comparative study is to test, for the first time, the bioactivity of a new "ready to use" calcium phosphate biomaterial in fillings of little losses of osseous substance from various origins, such as traumatic and benign tumoral causes.

lead_sponsor: Biomatlante

location_facility: CHU de Bordeaux - Hôpital PELLEGRIN -Service d'Orthopédie - Traumatologie C

location_facility: Service de Chirurgie Orthopédique et Traumatologique - CHU de la Pitié Salpétrière

location_facility: CHU de Fort de France - Hôpital Pierre ZODBA-QUITMAN - Service d'Orthopédie et Traumatologie

location_facility: CH des Broussailes - Service de Chirurgie Orthopédique et Traumatologique


title: Efficiency Assessment of a Mental Health Professionals' Training Course for a Short Psychoeducational Program (BREF) for Families and Caregivers of Patients With Schizophrenia or First Psychotic Episode.

acronym: BREFORM

summary:
In psychiatry, caregiver burden is associated with excess physical and psychological morbidity in relatives of patients with schizophrenic disorders Single or multi-family psychoeducation for caregivers of patients with schizophrenic disorders or first episode psychosis has a direct benefit on the health of the caregiver and an indirect benefit on the health of the ill family member. It is associated with a reduction in the rate of relapse and re-hospitalization and with better compliance with treatment. For single-family psychoeducation, the number of caregivers to be treated to avoid re-hospitalization of the sick family member is 3. For caregivers, psychoeducation is accompanied by an improvement in knowledge of the disorders and coping strategies. Therefore, international recommendations recommend that psychoeducation for caregivers be systematic, early, and integrated into routine care.

Currently, the organization of the French care system does not allow these recommendations to be met. In order to increase the use of psychoeducation in France, early interventions for caregivers must be offered systematically. The effectiveness of early psychoeducation for caregivers needs to be evaluated; only three randomized controlled trials are available in the literature and none have been conducted in France.

lead_sponsor: Hôpital le Vinatier

appel_a_projets: PREPS

nom_etablissement: CH LE VINATIER

type_etablissement: EPSM

acronyme: BREFORM

titre: Évaluation de l'efficacité d'une FORMation spécifique des professionnels de santé au programme court de psychoéducation BREF à destination des aidants d'usagers souffrant de premier épisode psychotique ou de troubles schizophréniques - Essai multicentrique contrôlé randomisé en Stepped-wedge

discipline_principale: psychiatrie / addictologie

nom_porteur: REY

prenom_porteur: Romain


title: Observatory of Unintentional Births Hospital Extras in Hérault

summary:
In France, pre-hospital unexpected birth is a rare situation, but over the last ten years, the investigators have seen an increase in the number of these.

For this, the investigators realize an observatory of these deliveries and their care from the call for help and the investigators continue the follow-up and the future of patients and newborns until J7 postpartum.

sponsor_collaborators:
University Hospital, Montpellier
SDIS34 - MONTPELLIER
SAMU CHU Montpellier


title: Study of the Diagnostic Value of "Rapid" High Throughput Genome Sequencing Analysis in Diagnostic Emergency Situations

acronym: FASTGEN

summary:
Rare diseases (affecting less than one in 2,000 people) are a major public health issue. There are about 8,000 rare diseases and they affect more than 3 million people in France. Most of these diseases are diagnosed in children, and they are responsible for 10% of deaths before the age of 5. Up to 80% of these diseases are believed to be of genetic origin. New generation high throughput sequencing (HTS) technologies, which allow the study of an individual's entire genome, have emerged in recent years as a tool of choice for the study of rare diseases. Our team was the first in France to demonstrate the value of exome sequencing (ES: all coding regions (exons), representing 1% of the total genome size) in the diagnosis of severe diseases in pediatric patients, developmental anomalies and intellectual disability.

Although it represents a significant advance in the diagnosis of genetic diseases, ES provides a contributing result in only about 30% of cases in patients with no obvious clinical diagnosis and with normal CGH-array. Sequencing the entire genome (GS) promises to improve the ability to study the causes of genetic diseases, with an expected diagnostic rate of 50 to 60% through the concomitant identification of point variations, CNVs and structural variations. While some international teams have already implemented GS in the diagnosis of rare diseases, only two teams report the use of trio GS in emergency situations in the neonatal period, with a low yield for first-line diagnostic use (31 and 42% respectively). It is therefore essential that these preliminary results be compared with other studies before considering the deployment of GS in diagnostic, early detection or rapidly evolving emergency situations, such as neonatal resuscitation or pediatric neurological distress.

lead_sponsor: Centre Hospitalier Universitaire Dijon

region: Bourgogne-Franche-Comté

nom_etablissement: CHU DIJON BOURGOGNE

acronyme: FASTGEN

titre: Étude de l'intérêt diagnostique de l'analyse "rapide" de séquençage haut débit de génome en situation d'urgence diagnostique

discipline_principale: autre

nom_porteur: SORLIN

prenom_porteur: Arthur


title: Retrospective Study of Singing-voice Disorders and Aerodynamic Profiles in Dysodic Singers

acronym: AeroDysodiaPro

summary:
Singers are over-represented in phoniatric consultation; they present increased risk of developing voice disorders. They represent a specific population among phoniatric patients (specific singing-voice complaints, increased sensitivity to voice). Singing-voice disorder is called dysodia in the same way as dysphonia, which refers to speaking-voice disorders. The diagnosis of dysodia is made after a laryngeal examination and a voice assessment to identify patient's speech and singing difficulties. Most studies on prevalence of voice disorders in singers come from the American continent. Very few descriptions of this population have been made in France.

Voice assessment of dysodic singers includes aerodynamic voice measurements. The use of aerodynamic measurements for the diagnosis of voice pathologies is now widely demonstrated. These parameters include measurements of estimated subglottal pressure (ESGP), phonation threshold pressure (PTP) (minimum pressure to initiate a sound) and oral airflow (OAF). They depend on the level of training of singers and the type of vocal dysfunction. Aerodynamic behaviours of dysodic singers have not yet been described, although they can help to better identify the singer's vocal difficulties and could be essential parameters for targeting more precisely rehabilitation exercises proposed in voice therapy.

This study aims to describe the characteristics of a French population of singers consulting in phoniatrics and their aerodynamic behaviours. Do the singers' aerodynamic parameters (pressure, flow) reflect the dysfunctions in singing voice? Based on results of the literature on speaking and singing non-pathological voice, the investigators hypothesize that during voice assessment, ESGP values will be increased and OAF ones will be decreased over the entire vocal range of the singer in case of voice pathology.

sponsor_collaborators:
University Hospital, Montpellier
GIPSA-lab, Grenoble, France


title: PALUREA: Severe Falciparum Imported Malaria in Adults: Clinical and Physiopathological Study

acronym: PALUREA

summary:
Plasmodium falciparum malaria remains a major public health problem in endemic areas, with approximately 2 million deaths each year, especially in tropical African countries.

In non-endemic industrialized areas, imported malaria is generally diagnosed in travelers, as well as immigrants from endemic countries. Such imported cases have increased worldwide, with approximately 7000 cases each year in France. Among these cases, 300 are severe requiring hospitalization in the intensive care unit (ICU) with an overall mortality rate of 10%, despite available effective care.

Many studies have been performed to evaluate clinical and physiopathological aspects of severe malaria in endemic areas but few data are available for imported malaria. Therefore, determinants of severe imported malaria are not well known. The majority of patients hospitalized in the ICU for severe malaria are white caucasians as well as those patients who die.

The present study has two main objectives:

(i) to describe the clinical spectrum of severe imported malaria and to assess outcome (mortality and neurological sequelae), and the biological interactions between host and the parasite,

(ii) to evaluate the role of gene polymorphisms, of parasitic factors in the occurrence of severe malaria with a case control study comparing severe and non-severe malaria in patients matched according to ethnic patterns. The intensity of the inflammatory response will also be studied in the two groups of patients.

ReferenceType: result

ReferenceCitation: Bruneel F, Hocqueloux L, Alberti C, Wolff M, Chevret S, Bedos JP, Durand R, Le Bras J, Regnier B, Vachon F. The clinical spectrum of severe imported falciparum malaria in the intensive care unit: report of 188 cases in adults. Am J Respir Crit Care Med. 2003 Mar 1;167(5):684-9. doi: 10.1164/rccm.200206-631OC. Epub 2002 Oct 31.


title: Detection of Plasma DNA by Allelotyping in Non Small Cell and Small Cell Lung Cancer Patients. Evolution During Treatment and Follow-up.

summary: The majority of lung cancer patients have a tumor-derived genetic alteration in circulating plasma DNA that could be exploited as a diagnostic tool. The aim of this study is to evaluate if plasma DNA can be used as a valuable non invasive test to monitor disease progression without assessing the tumor.

lead_sponsor: University Hospital, Strasbourg, France

location_facility: Service de Chirurgie Thoracique, Hôpital Civil

location_facility: Service de Pneumologie, Hôpital de Hautepierre


title: MoleculAr Profiling for Pediatric and Young Adult Cancer Treatment Stratification 2

summary:
FMG2025 continues the previous efforts to propose treatment for patients based on the molecular characteristics of their tumor at treatment failure in cancer precision medicine trials within standard of care in France. However, whereas FMG2025 is a descriptive effort providing the basis for clinical decisions, MAPPYACTS 2 will translate these findings to clinical actions. The symbiosis is critical to advance patient care.

Since 2012, the molecular profiling trials "MOlecular Screening for CAncer Treatment Optimization" (MOSCATO-01) and "MoleculAr Profiling for Pediatric and Young Adult Cancer Treatment Stratification" (MAPPYACTS) have included pediatric and adolescent patients with recurrent or refractory malignancy that underwent on-purpose biopsy or surgical intervention. Whole Exome Sequencing of tumor and normal tissue and RNA Sequencing of tumor tissue have been applied to detect genomic alterations that could lead to an adapted targeted treatment. Furthermore, ancillary studies were associated exploring circulating tumor DNA, the immune contexture of tumors and developing Patient-Derived Xenografts (PDX).

The FMG2025 project transfers the molecular profiling of advanced pediatric cancers into a global approach that is now considered standard of care in France. Subsequent clinical recommendations and decisions will be made based on discussions with biologists, scientist and physicians in the molecular and clinical molecular tumor boards. Associated ancillary research studies and links to clinical interventional studies remain essential elements of the program to provide clinical, translational and basic research in order to improve scientific knowledge.

The program is articulated in two main parts that are closely interacting:

FMG2025 - Cancers et leucémies pédiatriques en échec de traitement or equivalent international projects that cover the sequencing of tumor and blood samples and provide molecular reports.

The clinical study MAPPYACTS 2 that provides clinical and therapeutic discussions of the sequencing results and therapy recommendations via the clinical molecular tumor board reports. It collects molecular and comprehensive clinical data of the patients registered in FMG2025 or equivalent international projects and thereby constitutes the critical link to clinical interventional studies and its sponsors ensuring facilitated access to these trials. It also covers and coordinates ancillary research studies.

ipd_sharing_description: Study protocol Informed Consent Form

lead_sponsor: Gustave Roussy, Cancer Campus, Grand Paris


title: Long Term Evaluation of Young Adults Born to HIV-infected Mothers. A Cohort of Young Adults Infected With HIV Since Birth or During Childhood

acronym: CO19 COVERTE

summary:
Background: With the improvement of the prognosis for HIV-infected infants, thanks to the availability of antiretroviral therapies, young adults infected with HIV since birth are becoming an emerging group among the HIV-infected population. Morbidity, mortality and immunovirological evolution in these young adults need to be studied in a large population and compared to patients infected with HIV later in adulthood or to the general population in terms of mortality. Moreover, the study of accelerated or premature ageing, linked to HIV and/or antiretroviral therapy, is particularly interesting in this population.

Objectives: To study the transition to adulthood and the further evolution of HIV-1 or -2 perinatally infected young adults: 1) To study the teenager to adult transition in terms of clinical and immunovirological status, schooling and professional integration, sexuality and reproductive life, transition from paediatrics to adult departments; 2) To study prognosis, morbidity and mortality according to age, infection stage at the time of antiretroviral initiation and therapeutic history; 3) To study the incidence and expression of adverse events and the potential link to antiretroviral therapies; 4) To study the markers of a potential premature ageing, from the metabolic, cardiovascular and immunological points of view.

lead_sponsor: French National Agency for Research on AIDS and Viral Hepatitis


title: Evaluation of the Satisfaction and the Quality of Life of Patients After Breast Reconstruction as Part of Breast Cancer. Comparison of Several Technics.

acronym: SQUARE

summary:
Breast cancer is the most common cancer in women in France in term of repercussion, 58 698 people has been diagnosed in 2017. Breast cancer is often with good prognosis. The 5 years disease-free survival rate is 87%. Surgery has a major place in breast cancer treatment. Although the conservative surgery is preferred, it stays the indication of mastectomy for nearly 30% of cases. This radical surgery is often experienced by the patient as a mutilation with the impact that this entails from a psychological point of view but also on the quality of life. Breast reconstruction allows an improvement of quality of life with a better acceptance of the body scheme and the benefits in the psychological and sexual domains. The reconstruction is an integral part of the therapeutic care; however, it is not done systematically. Indeed, in France nearly 35% of patients benefit of breast reconstruction 5 years after the mastectomy.

Nowadays, several surgical technics are available to do the reconstruction: autologous technics and the reconstruction with implants. It can be differed or immediate. The strategy of reconstruction is established in accordance with many parameters: the morphology of the breast and of the patient, the state of the thoracic wall and history of radiotherapy, comorbidities, contraindication and of course the wish of the patient. According to the used technics, the reconstruction can sometimes extend to several months, especially for the exclusive fat reshaping which needs a lot of surgery. The autologous technics seems to give a better satisfaction to the patients in an esthetical point of view but we do not have many data including the fat reshaping.

Among the tests allowing the evaluation of quality of life of patients, the Breast-Q© is a self-questionnaire validated that is specific to the breast surgery and includes a module concerning the breast reconstruction. It allows evaluating the quality of life (physical, psychosocial and sexual well-being) and the satisfaction of patients (based on cosmetic results and the care). The reconstruction module includes 116 items in its post-surgery version and is adapted to different types of reconstruction.

The objective of our project is to evaluate the quality of life and the satisfaction of patients having an immediate or differed breast reconstruction according to the technics used, with the help of the validated questionnaire Breast-Q© and the additional questionnaires.

lead_sponsor: Institut Cancerologie de l'Ouest


title: Multicentre, Randomised Study to Determine the Relative Efficacy of Two Therapeutic Strategies in the Treatment of Children With Congenital Toxoplasmosis

acronym: TOSCANE

summary: Toxoplasmosis is a benign disease in healthy adults, but can be serious in the case of contamination during pregnancy: the parasite can pass through the placental barrier and infect the foetus. The severity of congenital infection varies, but in France, where maternal seroconversions during pregnancy are treated, the manifestations of the disease are often infraclinical at birth and only appear during the first years of life in the form of retinochoroiditis. In order to prevent long-term sequellae, children with confirmed congenital toxoplasmosis (TC) are treated with pyrimethamine combined with either sulfadiazine or sulfadoxine (Fansidar®). The relative efficacy of these two combinations has not yet been evaluated. Moreover, there is no consensus about the duration of the treatment, which varies, in France, from 12 to 24 months depending on the centre. Compared with the duration of parasitaemia in non-treated children, which can persist for up to 4 weeks, these treatments are very long. They are also far longer than the 3 months of treatment, which is in accordance with the World Health Organization (WHO) recommendations, given in Denmark to infants identified as being infected with the parasite during neonatal screening. A one-year treatment was developed in the United States, but it mainly concerns only symptomatic children, given the absence of generalised screening in the United States of America (USA). We have no arguments to justify the use of treatments lasting one year or more in children with asymptomatic or mildly-symptomatic TC. As these treatments carry certain risks, which may be severe, notably with regard to haematological or skin conditions, they have to be supervised closely with biological tests, which adds further constraints for both the children and their parents and increases the cost to health care systems.


title: Evaluation de l'intérêt de l'élastographie Ultrasonore et du Doppler Ultrasensible peropératoires Dans la Prise en Charge Chirurgicale Des Tumeurs cérébrales

acronym: ELASTOGLI

summary:
Surgery for brain gliomas is usually guided by different imaging techniques including neuronavigation MRI and intraoperative ultrasound that do not allow visualization of the low-density peri-lesional tumor infiltration present in gliomas and from which the tumor recurs.

Another important aspect in the management of glial tumors is the histological grade. The appearance of new vessels (called neo-angiogenesis) is one of the crucial steps in the life of these tumors, which signifies the transition to anaplasia.

This neoangiogenesis is diagnosed during the anatomopathological analysis of the operative specimen, and may be suspected on preoperative MRI on the so-called infusion sequences.

The objective of this project is to evaluate the potential of two ultrasound modalities - elastography and ultrasensitive Doppler - in helping the surgical management of brain tumors. Ultrasound elastography measures cerebral elasticity and thus indirectly the degree of tumor infiltration; while ultrasensitive Doppler measures intratumoral vascularization, and could therefore help in the diagnosis of tumor anaplasia.

ReferenceCitation: Lima GLO, Dezamis E, Corns R, Rigaux-Viode O, Moritz-Gasser S, Roux A, Duffau H, Pallud J. Surgical resection of incidental diffuse gliomas involving eloquent brain areas. Rationale, functional, epileptological and oncological outcomes. Neurochirurgie. 2017 Jun;63(3):250-258. doi: 10.1016/j.neuchi.2016.08.007. Epub 2017 Feb 1.

ReferenceCitation: Mahboob S, McPhillips R, Qiu Z, Jiang Y, Meggs C, Schiavone G, Button T, Desmulliez M, Demore C, Cochran S, Eljamel S. Intraoperative Ultrasound-Guided Resection of Gliomas: A Meta-Analysis and Review of the Literature. World Neurosurg. 2016 Aug;92:255-263. doi: 10.1016/j.wneu.2016.05.007. Epub 2016 May 10.

oa_host_type: repository

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

repository_institution: University of Birmingham - University of Birmingham Research Portal

repository_normalized: Pure (Denmark)

repositories_concat: Pure (Denmark)

unpaywall_oa_status: green

ReferenceCitation: Ferraro N, Barbarite E, Albert TR, Berchmans E, Shah AH, Bregy A, Ivan ME, Brown T, Komotar RJ. The role of 5-aminolevulinic acid in brain tumor surgery: a systematic review. Neurosurg Rev. 2016 Oct;39(4):545-55. doi: 10.1007/s10143-015-0695-2. Epub 2016 Jan 27.

publisher_dissemination: Springer-Nature

ReferenceCitation: Coburger J, Merkel A, Scherer M, Schwartz F, Gessler F, Roder C, Pala A, Konig R, Bullinger L, Nagel G, Jungk C, Bisdas S, Nabavi A, Ganslandt O, Seifert V, Tatagiba M, Senft C, Mehdorn M, Unterberg AW, Rossler K, Wirtz CR. Low-grade Glioma Surgery in Intraoperative Magnetic Resonance Imaging: Results of a Multicenter Retrospective Assessment of the German Study Group for Intraoperative Magnetic Resonance Imaging. Neurosurgery. 2016 Jun;78(6):775-86. doi: 10.1227/NEU.0000000000001081.

oa_host_type: publisher

publisher_dissemination: Wolters Kluwer Health

ReferenceCitation: Gerard IJ, Kersten-Oertel M, Petrecca K, Sirhan D, Hall JA, Collins DL. Brain shift in neuronavigation of brain tumors: A review. Med Image Anal. 2017 Jan;35:403-420. doi: 10.1016/j.media.2016.08.007. Epub 2016 Aug 24.

ReferenceCitation: Chauvet D, Imbault M, Capelle L, Demene C, Mossad M, Karachi C, Boch AL, Gennisson JL, Tanter M. In Vivo Measurement of Brain Tumor Elasticity Using Intraoperative Shear Wave Elastography. Ultraschall Med. 2016 Dec;37(6):584-590. doi: 10.1055/s-0034-1399152. Epub 2015 Apr 15.

publisher_dissemination: Georg Thieme

lead_sponsor: University Hospital, Tours


title: Effects on Quality of Life of Adapted Physical Activity Supervised by CAMI for Breast Cancer Patients.

acronym: APACAM

summary:
Every year in France, there are approximately 58,000 new cases of breast cancer, which is the leading cancer in women according to the National Cancer Institute.

Among the various tools in the fight against cancer, it is now proven that physical activity improves the prognosis of cancers, particularly breast cancer.

Indeed, APA (Adapted Physical Activity) reduces morbidity and mortality, the risk of recurrence and improves quality of life. It is one of the tools of the Ten-Year Cancer Control Strategy 2021-2030 of the anti-cancer plan.

However, it seems to be insufficiently proposed and prescribed in France at present.

CAMI (Cancer Arts Martiaux et Information) is a non-profit association comprising health professionals specifically trained to support cancer patients through APA. It works in collaboration with the Hospices Civils de Lyon and in particular the Gynecology Department of the CHU (University Hospital Center) of Croix Rousse.

According to the World Health Organization (WHO), quality of life is "an individual's perception of his or her place in life, in the context of the culture and value system in which he or she lives, in relation to his or her goals, expectations, norms and concerns. It is a very broad concept influenced in a complex way by the subject's physical health, psychological state, level of independence, social relationships as well as their relationship to the essential elements of their environment."

Quality of life is thus synonymous with well-being, perceived health and life satisfaction. The quality of a person's life is based both on the objective elements of his or her life (physical health, living environment and material and/or contextual conditions) and on his or her experience, which can be defined as the subjective quality of life.

Thus, quality of life is considered to be a multidimensional concept that is structured around four dimensions, the first of which encompasses the physical state (autonomy, physical abilities), the second the somatic sensations that often translate into the expression of pain, the consequences of trauma related to the disease or treatment.

With the increase in the incidence of breast cancer and the improvement in its prognosis, the number of breast cancer survivors has increased significantly. Quality of life has become an important outcome measure in clinical breast cancer surveys and survival studies, in addition to survival.

The investigators' main objective is to study the effects of APA managed by CAMI in routine practice, on the quality of life of breast cancer patients.

They also want to analyze how, by whom, and which patients are referred to CAMI to improve their care and describe the program offered by CAMI.

The aim of this research is therefore to establish an axis of work and improvement for the Gynecology Department of the Croix Rousse Hospital in order to better identify the patients for whom APA would be most beneficial, to better refer them to CAMI and to study in real practice the effects of APA on these patients.

study_start_date_type: Anticipated

location_facility: Service de Gynécologie-Obstétrique, Hôpital de la Croix-Rousse, Hospices Civils de Lyon


title: Effects of Progressive Interval Training on V02 Max in Chronic Heart Failure Patients

summary:
Heart failure (HF) is currently considered a common pathology, with 15 million adults in Europe and 26 million worldwide. The American Heart Association (AHA) estimates that their number will increase by 25% by 2030. In France, HF affects more than one million people. Because of the repeated hospitalizations of this disease, it is considered a costly pathology and with a high mortality rate (23.000 deaths per year in France). Moreover, HF is a severe pathology that affects the quality of life of patients and their families. Treatment and medical follow-up are required.

A cardiac rehabilitation program is also a primary indication according to the latest recommendations and repositories in Cardiology. Various studies show that "Interval Training" exercise program improves VO2 peak compared to a "continuous" program, which constitutes a major prognostic factor in the population of heart failure. However, it is sometimes a difficult program to offer to more deconditioned patients as it requires reaching powers around 80% - 95% of its maximum exertion capacity. So, a variant of the interval training is offered, called Progressive Interval Training (PIT), based on the same model as the conventional interval training (CIT), but with an increasing power and breathing threshold, so that the patient can adapt gradually.

The hypothesis is that PIT could improve VO2 peak better than CIT in cardiac rehabilitation program. Therefore, study the benefits of PIT training to improve the conditioning and quality of life of patients with chronic heart failure will be studied.


title: Influence du Type de Traitement du diabète de Type 1 (DT1) Sur la Charge Mentale Des Adolescents Avec un DT1 et Des Parents Ayant un Enfant Avec DT1.

acronym: CHAM&DIAB

summary: Influence of the type of treatment for type 1 diabetes (pump versus multiple injections versus closed loop) on the treatment burden of children and adolescents and their parents.

status: Not yet recruiting

lead_sponsor: University Hospital, Angers


title: Sentinel Lymph Node Identification in Case of Breast Cancer. Clinical Evaluation of a New Intra-operative Probe and a Mini Gamma Camera

summary: This project consists on the realization followed by the clinical validation of two medical instruments dedicated to the precise sentinel lymph nodes identification and localization in the case of breast cancer: an intra operative probe and an operative mini gamma camera. The sentinel lymph node technique, based on the propagation of cancer cells in the lymphatic system, allows a better evaluation of tumor staging, prognosis and therapeutic strategy determination. The goal of these instruments designed by physicians and physicists is to significantly improve the detection efficiency of the technique in order to reduce the false negative rate and then the recurrence risk, as well as the operative morbidity.Clinical oncologist surgeons and fundamental physics applied to medical imaging researchers are involved in this project. The clinical validation of the medical instruments will be organized in the Gynaecologic and Obstetric department of the Hospices Civils de Strasbourg with a series of 25 patients in the framework of a regular french protocol of clinical research.

ReferenceCitation: Mathelin C, Salvador S, Bekaert V, Croce S, Andriamisandratsoa N, Liegeois P, Prados E, Guyonnet JL, Grucker D, Brasse D. A new intraoperative gamma camera for the sentinel lymph node procedure in breast cancer. Anticancer Res. 2008 Sep-Oct;28(5B):2859-64.

ReferenceCitation: Mathelin C, Salvador S, Croce S, Andriamisandratsoa N, Huss D, Guyonnet JL. Optimization of sentinel lymph node biopsy in breast cancer using an operative gamma camera. World J Surg Oncol. 2007 Nov 17;5:132. doi: 10.1186/1477-7819-5-132.

collaborators: Centre National de la Recherche Scientifique, France

collaborators: Institut Pluridisciplinaire Hubert Curien, Strasbourg

location_facility: Service de Gyynécologie-Obstétrique -Hôpital Civil


acronym: RITUX-PLUS 2

lead_sponsor: Assistance Publique - Hôpitaux de Paris

summary:
Primary immune thrombocytopenia (ITP) is an autoimmune disease mainly mediated by autoreactive B cells and the presence of pathogenic anti-platelet auto-antibodies that enhance platelet destruction and impair platelet production. There are approximately 4,000 newly diagnosed ITP cases each year in France. For patients with a platelet count of less than 30x109/L and/or bleeding symptoms, corticosteroids alone or in combination with intravenous immunoglobulin (IVIg) is the standard first-line treatment. However, approximately two-thirds of adult patients responding to this first-line treatment relapse within days or weeks after corticosteroids withdrawal and overall, the course of the disease is chronic in about 70% of the cases. The anti-CD20 monoclonal antibody rituximab is commonly used off-label as a second-line therapy in many European countries including France for adults with persistent (i.e., disease duration of more than 3 months) or chronic (disease duration of more than 12 months) ITP. Rituximab leads to an overall response rate of only 40 % at 1 year but 29.5% of lasting (5 years and more) response The investigators have shown that the absence of response to rituximab in ITP could be explained by the settlement and expansion of long-lived autoreactive plasma cells in the spleen made possible by the high amount of BAFF. Belimumab is a fully humanized anti-BAFF/Blys monoclonal Ab licensed for SLE. Based on the preliminary results of a phase 2 open prospective pilot study performed in our center combining rituximab with i.v belimumab seems highly promising We hypothesized that combining subcutaneous belimumab weekly over a 24 weeks period (Arm A) with rituximab is superior to rituximab and subcutaneous placebo weekly over 24 weeks period (Arm B) to achieve an overall response at W52.

The study design will be a prospective randomized, double-blind, multicenter (international), superiority phase III clinical study

sponsor_collaborators:
Assistance Publique - Hôpitaux de Paris
GlaxoSmithKline

title: A Phase 3 Randomized and Double-blind Controlled Trial Comparing the Efficacy and Safety of Subcutaneous Belimumab or Placebo in Addition to Rituximab in Adult Patients With Persistent or Chronic Immune Thrombocytopenia (ITP)