title: A Phase II Study to Evaluate the Efficacy and Toxicities of PLX038, in Patients With Locally Advanced or Metastatic Triple-negative Breast Cancer

acronym: TOPOLOGY

summary: Single arm phase II study for with primary objective to evaluate the efficacy of PLX038 on response rate for patients with pretreated, metastatic or locally advanced triple negative breast cancer.

sponsor_collaborators:
Institut Curie
ProLynx LLC


type: Other Identifier

title: Association of Dysbiosis and Immune Response in Bronchiolitis in Under 12 Months -Old Infants

acronym: BRONCHOBIOTE

summary: Acute bronchiolitis is a common disease in children under the age of two, caused mainly by the respiratory syncytial virus (RSV). Furthermore, given the same medical history, it is still very difficult to predict the course and severity of the infection at the onset of symptoms, Some studies have highlighted the importance of the microbiota (intestinal, oral or nasopharyngeal) and of the immune response to RSV in children, We will include 80 children under 2 years old with hospitalized bronchiolitis and non-hospitalized bronchiolitis. Oral, nasal and stool samples will be taken to study the various microbiota in search of dysbiosis. A capillary blood sample will be taken for immune studies.

study_start_date_type: Anticipated

status: Not yet recruiting

study_completion_date_type: Anticipated

study_type: Interventional

design_allocation: Non-Randomized

primary_purpose: Basic Science

enrollment_type: Anticipated

ipd_sharing: No

lead_sponsor: Assistance Publique - Hôpitaux de Paris

collaborators: Infectious Diseases Models for Innovative Therapies center

location_facility:
AP-HP,Raymond Poincaré Hospital
APHP, Antoine Béclère Hospital

intervention_type: Other

lead_sponsor_type: academique

status_simplified: Ongoing


title: Evaluation of Human Papillomavirus Vaccine Coverage in Girls and Young Women With Chronic Disease

acronym: MC-HPV

summary: The main objective of the study is to determine the vaccination coverage rate for human papillomavirus in adolescents aged 11 to 20 with chronic disease and treated at the Necker-Enfants Malades Hospital, compared to a population witnessed adolescent girls aged 11 to 20 years without chronic disease.

study_type: Observational

time_perspective: Prospective

ReferenceType: background

ReferenceCitation: Hofstetter AM, Camargo S, Natarajan K, Rosenthal SL, Stockwell MS. Vaccination Coverage of Adolescents With Chronic Medical Conditions. Am J Prev Med. 2017 Nov;53(5):680-688. doi: 10.1016/j.amepre.2017.07.017. Epub 2017 Sep 18.

ReferenceCitation: Gras-Le Guen C, Legrand A, Caquard M, Micaelli X, Picherot G, Lacroix S, Volteau C, Launay E. Chronically ill adolescents are also incompletely vaccinated: A cross-sectional study in France. Vaccine. 2017 Aug 24;35(36):4707-4712. doi: 10.1016/j.vaccine.2017.07.042. Epub 2017 Jul 29.

ReferenceCitation: Hoffman L, Okcu MF, Dreyer ZE, Suzawa H, Bryant R, Middleman AB. Human papillomavirus vaccination in female pediatric cancer survivors. J Pediatr Adolesc Gynecol. 2012 Oct;25(5):305-7. doi: 10.1016/j.jpag.2012.05.004. Epub 2012 Jul 24.

location_facility: Centre Médical Spécialisé de l'Enfant et de l'Adolescent (CMSEA)


title: Imaging Study of Anatomical Variations of the Superficial Temporal Artery

acronym: EVATSI

summary: This study focuses on the anatomy of the superficial temporal artery, an artery of the head. Knowledge of the anatomy of this artery, and the evaluation of methods for exploring it, have implications for clinical medical and surgical practice.

study_start_date_type: Actual

status: Recruiting

time_perspective: Retrospective

ipd_sharing: Yes

ipd_sharing_description: All collected data that underlie results in a publication

lead_sponsor: University Hospital, Brest


title: Postpartum Experience by the Second Parent

summary:
Many studies have been performed on mothers and their postnatal experiences. Unfortunately, studies about the second parent are very rare. Second parent is yet an essential figure in the parent-child triad and a real support for the mother.

The postpartum period is a time of intense restructuring and upheaval, both physically and psychologically. Studies have shown that almost 13% of fathers suffer from depression.

time_perspective: Cross-Sectional

ipd_sharing: Undecided

lead_sponsor: Université de Reims Champagne-Ardenne

location_facility:
Université de Reims Champagne Ardenne
Ufr Medecine Urca


title: Management of Women With Superficial Dyspareunia

acronym: dyspareunie

summary:
Superficial dyspareunia are persistent or recurrent pains during an attempt at sexual intercourse or during effective penetration.

They affect between 3 to 18% of women and are a source of physical and psychological suffering.

Some health professionals (gynecologists, general practitioners, midwives) are confronted daily with these complaints.

The approach of sexuality remains a complex subject even within the medical field. As a result, communication between women and health professionals can be difficult, leading to delayed diagnosis or inadequate management.


title: Effectiveness of the PHOENIX Smartphone Application on the Nursing Management of Craving in Patients With Addictive Disorders Followed on an Outpatient Basis

acronym: PHOENIX

summary: The objective of this study is to evaluate the effectiveness of the addition of nursing follow-up and the PHOENIX application, a personalized and self-adaptive Smartphone application, on the management of craving in patients with addictive disorders followed on an outpatient basis.

design_allocation: Randomized

primary_purpose: Supportive Care

lead_sponsor: Centre Hospitalier St Anne

sponsor_collaborators:
Centre Hospitalier St Anne
Direction Générale de l'Offre de Soins

location_facility:
CHU de Nantes
Hospices Civiles de Lyon

intervention_type: Behavioral


title: The ECOSTRESS Study: Influence of the Objective Structured Clinical Examination on Stress Among Medical Student

acronym: ECOSTRESS

summary: We will assess stress using heart rate variability during examination on medical student. Three time of measurement will be performed. First standardized objective clinical examination, second classic table examination and third a control day.

lead_sponsor: University Hospital, Clermont-Ferrand

location_facility:
Medical School of Clermont-Ferrand
CHU clermont-ferrand


title: Subjects Perceived as Embarrassing During a Consultation in General Medical Practice

acronym: Gene-MG

summary:
Optimal medical care requires transparency and honesty. However, it is not always easy to address some issues that may be considered too personal, intimate or taboo, such as mental health, sexuality, addiction and death. Patients' approach to these issues may be influenced by the profile of their general practitioner, or by the atmosphere of the consultation.

This retention of information by the patient, whether voluntary or not, can lead to adverse events related to care due to a misunderstanding between doctor and patient.


title: Can a Patient in Intensive Care be Visited by His or Her Pet? Feasibility Study.

acronym: ACCOMPAGNE

summary:
Nearly half of all intensive care patients describe symptoms of anxiety and depression after a stay in the ICU, and one in five has genuine post-traumatic stress disorder.

As a result, improving patient experience has become a priority in the ICU, and particular attention is being paid to the need to recreate a familiar environment.

Animal-mediated interventions have been developed for a number of patients over many years. These strategies are widely used with elderly patients, and patients with cognitive or psychiatric disorders, for whom the literature shows benefits on anxiety, mood or objective signs of stress.

In the vast majority of experiments carried out to date, the animals (mainly dogs) were prepared and educated for contact with patients, and their handlers trained in this activity, rather like guide dogs. Visiting a care facility with a patient's own pet is rarely described. It may run up against obstacles related to the animal's behavior or infectious risks, but it is nevertheless authorized in many establishments.

primary_purpose: Other

lead_sponsor: Centre Hospitalier Universitaire de Saint Etienne

location_facility:
Centre Hospitalier de Saint-Etienne
Centre Hospitalier Ardèche Nord


title: Pregnant Women's Knowledge of the Active and Passive Smoking Effects on Pregnancy and the Fetus

acronym: tabac-GO

summary:
There are two remaining areas where the standards for tobacco use during pregnancy have changed little: one area is the high level of consumption by pregnant women and the other is the limited care given to pregnant women.

Indeed, many pregnant women are still over-exposed to tobacco, either through personal use or passive exposure to cigarette smoke. This passive exposure often comes from the consumption of their loved ones, such as their future co-parent or family.

However, throughout our lives, health professionals, associations, and the government send a lot of information and messages about the negative effects of tobacco on health, pregnancy, and the fetus.

This information and the possibility of receiving help from a professional trained in tobacco use exist throughout the entire pregnancy.

However, many women and their partners still do not take the necessary precautions to reduce or stop smoking. Do couples who smoke during pregnancy really have an understanding of the smoking's effects on women and their fetuses? Could they realize it and would they reduce or stop their consumption, in case they knew these negative effects?


type: Registry Identifier

title: Pilot Study on the Effect of Oxiris Haemofiltration Membrane on Haemodynamic Stabilisation and Clearance of Vasoactive Metabolites

acronym: VITAL

summary:
Extracorporeal blood purification is a supportive therapy in the management of patients with sepsis or vasoplegic shock. The pathophysiology of sepsis is based on an inappropriate host response to infection. Certain medical devices with higher adsorption capacity make it possible to limit this inappropriate response and could thus improve the hemodynamics of patients in septic or vasoplegic shock. The preliminary experience of the investigators from clinical data of vasopressor withdrawal in pediatric patients treated with oXiris shows a 50% reduction in the vasopressor score, Vaso Inotropic Score (VIS), for 40% of patients within 24 hours following the start of treatment. Similar results were found in adult patients treated for severe COVID-19 or vasoplegic shock by the other centers participating in the study.

Cytokine purification is an important physiological effect of purification membranes. However, this may not fully explain the rapid hemodynamic improvement of patients treated with an oXiris membrane.

The role of angiotensin metabolites (Ang 1-5, 1-7, 1-9) in the systemic vascular tone of patients has been recently discussed. The administration of angiotensin 2 in vasoplegic shock in adults helps correct hypotension. In the group of patients with increased renin, this treatment was associated with a reduction in mortality. Indeed, increased renin associated with dysfunction of Angiotensin Converting Enzyme (ACE) leads to an accumulation of Angiotensin 1 which degrades to Ang 1-7.

The hypothesis f the investigators is that the concentration of Ang 1 and Ang 1-7 is elevated in cases of vasoplegic shock and that the clearance of these vasodilator peptides by blood purification is associated with clinical improvement.

location_facility:
Bicetre hospital
Garches hospital


title: Post-marketing Clinical Investigation to Assess Real-life Usage Effectiveness, Safety and Patient Satisfaction of a Range of Hypertonic Seawater-based Decongestant Nasal Sprays

summary:
The brief of this observational study is to evaluate usage, efficacy, safety and patient satisfaction of a range of hypertonic seawater-based decongestant nasal sprays in general population.

The main questions it aims to answer are:

Usage,
Efficacy,
Safety,
Satisfaction, in real-life usage with children, adults and pregnant or breastfeeding women. Participants will use the nasal spray as usual habits and complete daily questionnaires.

lead_sponsor: Laboratoire de la Mer

sponsor_collaborators:
Laboratoire de la Mer
Slb Pharma

location_facility:
Annie Le Gall
Alexandra Crevecoeur

intervention_type: Device

lead_sponsor_type: industriel


title: Maestro 1.0 Post-Market Registry

summary: The objective of the study is to observe the real-life usage of the Maestro Platform for surgical assistance in laparoscopic surgery.

lead_sponsor: Moon Surgical

location_facility:
Polyclinique de Franche-Comté
Institut Arnault Tzanck


title: Study of Prevalence of Eating Disorder in Liver Transplant Patients

acronym: Pré-THETA

summary:
The main goal of this observational study is to measure the prevalence of binge eating disorder in liver transplant patients by evaluating the responses to the Bulimia Test.

Secondary objectives of the study are to:

Determine the prevalence of binge eating disorders in liver transplant patients following alcoholic cirrhosis, evaluated by the Bulimia Test;
Study the association between the presence of eating disorder behaviours and liver damage : hepatic steatosis and fibrosis determined by Fibroscan (Transient elastography and controlled attenuation parameter)
Study the association between presence of eating disorder behaviours and alcohol use disorder, measured by Alcohol Use Disorders Identification Test-Consumption

time_perspective: Other

lead_sponsor: Centre Hospitalier Henri Laborit

location_facility: University Hospital of Poitiers (CHU de Poitiers)


title: Early Breast Growth in Girls Aged 6 to 8 Years in the Current Environmental Context: Clinical and Biological Parameters, Level of Impregnation With Endocrine Disruptors and Evaluation of the Impact of Environmental Health Measures

acronym: PENELOPE

summary:
Various studies show an increase in the number of cases of early puberty in girls with breast development with a variable clinical presentation and evolution. This increasing phenomenon concerns girls between 6 and 8 years old. In a large number of cases, from 70 to 95% depending on the series, no medical cause is found and environmental factors are suspected to be involved.

Descriptive studies of these patients are scarce and not always provide an overview of all the parameters in line with the concept of the exposome.

The PENELOPE clinical trial will allow to analyze a large number of parameters, including the adipose tissue, its metabolism, the endocrine disruptors, and the epigenetic modifications, and to study the impact of environmental health measures in the evolution of these parameters.

The data from the analyses of the endocrine disruptors of the patients will be explored in parallel in experimental models (amphibians, murine, cellular) in order to test potential mechanistic hypotheses.

primary_purpose: Prevention

lead_sponsor: Lille Catholic University

location_facility:
Cabinet BLM
Saint Vincent hospital


title: Clinical and Healthcare Economic OutcoMes From ReAl-worlD Use in Europe of an AI Software During AF Ablation

acronym: COMRADE-AI

summary: The goal of this Observational Prospective Multi-center Study is to observe the acute and long-term safety and performance outcomes after spatiotemporal dispersion-based AF/AT ablation utilizing the Volta Medical AI software in "real-life" clinical practice, without any imposed clinical workflow. Moreover, this study will allow to collect medico-economic data related to the tailored ablation strategy guided by the Volta Medical AI software.

ReferenceCitation: Seitz J, Bars C, Theodore G, Beurtheret S, Lellouche N, Bremondy M, Ferracci A, Faure J, Penaranda G, Yamazaki M, Avula UM, Curel L, Siame S, Berenfeld O, Pisapia A, Kalifa J. AF Ablation Guided by Spatiotemporal Electrogram Dispersion Without Pulmonary Vein Isolation: A Wholly Patient-Tailored Approach. J Am Coll Cardiol. 2017 Jan 24;69(3):303-321. doi: 10.1016/j.jacc.2016.10.065.

oa_host_type: repository

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

host_type: repository

license_normalized: no license

repository_institution: PubMed Central - Europe PMC

repository_normalized: PubMed Central

version: acceptedVersion

evidence: oa repository (via pmcid lookup)

repositories_concat: PubMed Central

unpaywall_oa_status: green

publisher_dissemination: Elsevier

ReferenceCitation: Seitz J, Durdez TM, Albenque JP, Pisapia A, Gitenay E, Durand C, Monteau J, Moubarak G, Theodore G, Lepillier A, Zhao A, Bremondy M, Maluski A, Cauchemez B, Combes S, Guyomar Y, Heuls S, Thomas O, Penaranda G, Siame S, Appetiti A, Milpied P, Bars C, Kalifa J. Artificial intelligence software standardizes electrogram-based ablation outcome for persistent atrial fibrillation. J Cardiovasc Electrophysiol. 2022 Nov;33(11):2250-2260. doi: 10.1111/jce.15657. Epub 2022 Sep 18.

ReferenceCitation: Deisenhofer I. Electrogram-based AF ablation: finally, reproducibility! J Cardiovasc Electrophysiol. 2022 Nov;33(11):2261-2262. doi: 10.1111/jce.15660. Epub 2022 Sep 18. No abstract available.

lead_sponsor: Volta Medical

sponsor_collaborators:
Volta Medical
Fortrea

location_facility:
Clinique Pasteur
Hôpital Saint-Joseph


title: Neurocognitive Impact of Different Irradiation Modalities for Patients With Grade I-II Skull Base Meningioma: A Prospective Multi-Arm Cohort Study

acronym: CANCER-COG

summary: For the purpose of this research, investigator will constitute several cohorts of patients, treated either by intensity-modulated radiotherapy, stereotactic radiotherapy or proton-therapy. This will allow better understanding the cognitive and anatomical damages caused by new radiotherapy techniques and better understanding how ionising radiation (X-rays or protons) acts in the long term on brain tissue. Longitudinal follow-up will be multimodal, based on yearly multi-parametric brain MRI to assess morphological changes, in relation with dosimetric data as well as neuropsychological performances, health-related quality of life, anxiety and depression disorders, memory tasks, and socio-professional reintegration. This will notably make it possible to evaluate the relationship between dosimetric data, age at the time of treatment, region of the brain irradiated, type of radiation used, dose per fraction, neurocognitive and neuro-anatomical consequences. A Normal Tissue Control Probability (NTCP) model will be also developed. Overall, the results of this study should contribute to the improvement of treatment techniques, in particular by preserving as much as possible the significant cerebral zones (hippocampi, frontal lobe, sub-ventricular zones, etc.), and to the management of patients by proposing appropriate support measures. In the proton-therapy cohort, evaluations will make it possible to establish more precisely the place that this new irradiation strategy should occupy in the management of low grade meningioma. Importantly, investigator have planned to constitute a last cohort, with subjects free of any neurological disease, to make it easier the interpretation of cognitive performances over time among patients in the three brain radiation cohorts.

primary_purpose: Treatment

lead_sponsor: Centre Francois Baclesse

sponsor_collaborators:
Centre Francois Baclesse
Région Normandie

location_facility:
Centre Henri Becquerel
centre François Baclesse


title: Plasma Dosage of Venetoclax in the Follow-up of Acute Myeloid Leukemias Ineligible for Intensive Chemotherapy in the First Line of Treatment and Treated With Azacitidine + Venetoclax. Pilot Study VENETACIBLE

acronym: VENETACIBLE

summary: The study proposes to correlate the plasma dosage of VEN with the inhibition of its Bcl-2 target during the first treatment cycle. VEN will be measured sequentially during the first treatment cycle and assess inhibition of its target by measuring the level of phosphorylation of Bcl-2 serine 70. In parallel, BH3 profiling will be evaluated sequentially. All these analyses will be correlated with treatment toxicity, response rate and overall patient survival. This pilot study will highlight the inter-individual variability of this AZA + VEN combination, and enable to launch a national study via the national cooperative groups to validate the results and thus ultimately propose a personalized treatment for patients benefiting from this combination.

lead_sponsor: Centre Hospitalier Universitaire de Nice

location_facility:
CHU de Nice
Hopital la Conception

intervention_type: Drug


title: Feasibility of an Adapted Sports Program Based on Fencing to Reduce Physical Deconditioning in Adult Hematology Patients Receiving Intensive Treatment

acronym: EscrimHEMA

summary:
In 20 years, the prognosis of hematology patients has improved thanks to the development and adaptation of treatments and better risk management. However, medium and long-term complications of intensive treatments are common and remain a real public health problem. Indeed, intensive treatments associated with room confinement within a protected unit expose patients to physical deconditioning of multifactorial pathophysiological mechanisms. If this deconditioning is neglected, response to treatment, tolerance, quality of life and, in the longer term, survival will be impacted.

Several teams have demonstrated the feasibility and the benefits of physical support for patients with prolonged aplasia. These studies focused on peripheral stem cell allograft, which occur late in the treatment of acute leukemia. On the other hand, studies evaluating the benefits of physical support as soon as the diagnosis of acute leukemia is made and intensive treatments are started are rare. Implementing a adapted sport program from the diagnostic and throughout the course of treatment is therefore a worthwhile subject for research.

The adapted sport chosen was fencing because it responds to hematological problems. Fencing is adaptable without carrying or receiving blow, can be practiced standing up, in an armchair or in bed, involves praxis and concentration, and involves the whole body. It can be practiced individually or as part of a team, in a protected room or in a unit corridor. Fencing is a fighting sport and includes a psychological aspect, with a possible projection of a fight against the disease. In addition, fencing is carried out by a non-medical or paramedical practitioner, which can reinforce or recreate an image of normal activity. Finally, the attention required by listening to the fencing master and the necessary concentration unconsciously pushes the patient to "get out of his illness".

The aim of this pilot study is to assess the feasibility, throughout the care pathway, of an adapted sport program based on fencing in adult patients with hematological malignancies receiving intensive treatment, to reduce physical deconditioning.

lead_sponsor: University Hospital, Angers

location_facility:
University Hospital, Angers
University Brest Hopspital


title: Effects of Transcranial Direct Current Stimulation (tDCS) in the Management of Suicidal Ideation in Treatment-resistant Depression : a Pilot Study

acronym: tDCS-IDSDEP

summary: The main objective of this study is to demonstrate that 15 transcranial direct current stimulation (tDCS) sessions of 30 minutes at 2 mA intensity are effective to reduce suicidal ideation

location_facility:
Centre Hospitalier Henri Laborit
Centre Hospitalier Nord-Deux-Sèvres


title: An International Field Study for the Reliability and Validity of the EORTC PATSAT-C33 and the EORTC OUT-PATSAT7 Questionnaires

acronym: PATSAT

summary: The aim of this study is to validate the EORTC PATSAT-C33 and EORTC OUT-PATSAT7 questionnaires scale structure in a large international field study.

lead_sponsor: Institut Curie

location_facility:
Institut de Cancérologie de Lorraine
Institut Curie


title: Impact of Circadian Rhythm on the Spread of Circulating Tumor Cells in Lung Cancer Patients

summary:
This is a prospective pilot study designed to demonstrate the impact of circadian rhythm on the spread of Circulating Tumor Cells (CTCs) in patients with Non- Small Cell Lung Cancer - NSCLC.

27 patients will be included in the study and will be followed for 12 months.

For each included patient, blood samples will be collected before the anticancer treatment initiation.

lead_sponsor: Institut Claudius Regaud

location_facility: Institut Universitaire du Cancer de Toulouse - Oncopole


title: Protection Response to Cellular Stress in BPAN's Patient Study

acronym: REP-BPAN

summary:
BPAN (beta-propeller associated neurodegeneration) is caused by mutations in the autophagy gene WDR45, also known as WIPI4, located on the X chromosome. Mutations in WDR45 result in neurodevelopmental impairment in girls and early-onset epileptic encephalopathy in boys, followed by neurodegeneration in adults (SENDA). This condition is a subtype of neurodegeneration with brain iron overload (NBIA). BPAN is the most recently identified subtype of NBIA and it is important to understand how mutations in WDR45, present in patients∙e∙s, cause cell death.

Autophagy is a cell survival mechanism responsible for the degradation and recycling of cell contents. It has been proposed that autophagy becomes less efficient during normal aging, which could cause neuronal death and thus lead to neurodegeneration.

Reduced autophagic activity has been observed in lymphoblastic cells of BPAN patients and in brains of KO mice for WDR45. The current hypothesis to explain the pathology associated with WDR45 mutations is that a defect in autophagy leads to neurodegeneration. However, we do not know if the autophagy defect is causal or if other deregulations of cellular responses contribute to neurodegeneration. Preliminary results from Pr. Bertrand Mollereau's team suggest that a global deregulation of cellular stress responses may be induced in patient cells. This includes in particular the endoplasmic reticulum response to stress (UPR response) as well as lipid storage mechanisms.

The investigators hypothesize that cells from patients carrying pathogenic variants of WDR45 will exhibit deregulation of cellular stress response pathways.

lead_sponsor: Hospices Civils de Lyon

location_facility: Service de génétique - Laboratoire de Biologie Médicale Multi-Site (LBMMS) Groupement Hospitalier Est - Hospices Civils de Lyon

intervention_type: Biological


title: Evaluation of the Value of Measuring Pulmonary Arterial Pressures During Exercise in Hereditary Haemorrhagic Telangiectasia Patients With Hepatic Involvement - Pilot Study

acronym: ROSE

summary:
The hepatic involvement of HHT (Hereditary Haemorrhagic Telangiectasia) disease is characterised by the formation of arterio-sus-hepatic shunts which lead to dilatation of the hepatic artery and may result in high output heart failure. This evolves silently for long-standing period from left ventricular cavities dilatation to advanced heart failure with post-capillary pulmonary hypertension (PH) (more rarely pre-capillary), and its evolution is poorly understood. The specific treatment options for HHT disease are either the use of anti-angiogenic therapy (bevacizumab) or liver transplantation. As rest echocardiography can only detect advanced cases or heart failure with rest PH, the investigators speculate that exercise echocardiography can provide additional information in patients without rest PH. The hypothesis is that an exaggerated pulmonary pressure increase during exercise may precede the occurrence of rest PH in the course of the disease. It could identify patients with substantial heart failure at an earlier stage and may facilitate the access to liver transplantation. These parameters have never been studied in this context and it seems interesting to evaluate them in this pilot study.

The investigators hypothesise that HHT (Hereditary Haemorrhagic Telangiectasia) patients with hepatic involvement and cardiac high output will have significantly greater and/or earlier elevation of exercise pulmonary arterial pressures than those with normal cardiac output.

primary_purpose: Diagnostic

location_facility: Service Explorations fonctionnelles cardiovasculaires - Hôpital Louis Pradel

location_facility: Service génétique - Hôpital Femme Mère Enfant


title: Involvement of the Serotonergic System in the Control of Impulsivity in Tourette Disorder.

acronym: ARITEP

summary: Tourette disorder (TD) is a neurodevelopmental disorder characterized by motor and vocal tics. It is often associated with multiple psychiatric comorbidities involving a high degree of impulsivity such as obsessive-compulsive disorders (OCD), attention-deficit hyperactivity disorders (ADHD), and intermittent explosive disorders (IED). Although a substantial body of clinical studies have emphasized the role of the dopamine system in motor symptoms, little is known about how the serotonergic (5-HT) system modulate both cognitive and affective abilities in TD. Several lines of evidence suggest that different 5-HT receptor subtypes may constitute a crucial factor in the development and maintenance of different symptoms. Because abnormal 5-HT2A receptor bindings have been reported in patients with TD and aripiprazole (drug of first choice) is a 5-HT2A antagonist, we hypothesize that 5-HT2A receptors may play an important role in regulating psychiatric symptoms in TD such as those characterized by impulsive behaviors. To investigate the involvement of 5-HT2A receptors in TD, we propose to perform a multimodal imaging study with 20 adult patients (ON and OFF treatment). Neuroimaging data will be collected with a hybrid system that simultaneously combines the positron emission tomography (PET) and the functional magnetic resonance imaging (fMRI). A highly selective PET radiotracer ([18F]-altanserin) will map 5-HT2A receptor bindings in the whole brain, while fMRI will provide detail information regarding the altered brain activities.

location_facility: Service de neurologie C Hôpital neurologique Pierre Wertheimer/GHE Hospices Civils de Lyon

location_facility: Centre de Référence Syndrome Gilles de la Tourette Département de Neurologie Pôle des Maladies du Système Nerveux Hôpital de la Pitié-Salpêtrière


title: Improved Hemodynamic Tolerance of Intermittent Hemodialysis Sessions in Intensive Care Unite (ICU) Using Citrate- vs Acetate-based Dialysate

acronym: HEMODIACIDE

summary: During intermittent hemodialysis (IHD), the occurrence of intradialytic hemodynamic instability (IHI) is frequent in ICU and impacted morbidity and mortality. Bicarbonate dialysate buffer improves hemodynamic tolerance compared to acetate dialysate buffer. However, bicarbonate dialysate buffer still contains a lower concentration of acetate, which could contribute to hemodynamic instability. Recently, citrate-based dialysate in bicarbonate hemodialysis instead of acetate have been proposed. They have the appropriate authorizations for routine use. The aim of this study is to compare acetate- vs citrate-based dialysate in terms of hemodynamic tolerance and effectiveness.

lead_sponsor: Centre Hospitalier de Bethune

sponsor_collaborators:
Centre Hospitalier de Bethune
CHU de Lille

location_facility: Centre Hospitalier Universitaire de Caen


title: Randomized Trial Comparing Low Pressure in Laparoscopic Colorectal Resection With Warm and Humidified Carbon Dioxide Pneumoperitoneum Versus Low Pressure Pneumoperitoneum Alone

summary:
To improve post-operative recovery, medical device was developed combining low-pressure pneumoperitoneum and heated and humidified Carbon Dioxide (95˚F & 95% RH) during laparoscopic surgery to reduce the harmful effects of cold/dry insufflation.

A double-blind, prospective, randomized, controlled, monocentric trial is designed in the aim to assess the impact of low-pressure pneumoperitoneum with warm and humidified gaz on post-operative pain at 24 hours without taking opioids. It is compared with low-pressure laparoscopy with cold and dry gaz in patients undergoing colorectal surgeries.

lead_sponsor: Bordeaux Colorectal Institute Academy

location_facility: HOPITAL NORD APHM - Service de Chirurgie Digestive

location_facility: Clinique TIVOLI DUCOS - Bordeaux Colorectal Institute

intervention_type: Procedure


title: Contribution of Residual Tumour DNA Testing on the Surgical Bed of Squamous Cell Carcinomas of the Oral Cavity

acronym: MARGINS

summary: The aim of this study is to evaluate the interest of residual tumour DNA research in the operating bed after squamous cell carcinoma excision.

lead_sponsor: Centre Henri Becquerel

location_facility:
Centre Henri Becquerel
CHU Rouen


title: Immune-related Adverse Events From Immune Checkpoint Inhibitor Characterization Using VigiBase, the WHO Pharmacovigilance Database: An Exploration of Adverse Event Patterns and Signal Detection.

acronym: EXIT

summary:
This is an observational, retrospective pharmacovigilance study based on reports registered and transmitted in VigiBase®, the WHO's international database.

This study includes all reports identified as exposure to an ICI and suspect of inducing adverse drug reaction.

The aim of the study is to characterize immune-related adverse reactions associated with immune-checkpoint inhibitors, particularly their time-to-onset, co-occurence, factors associate with their over-report and fatality.

lead_sponsor: Groupe Hospitalier Pitie-Salpetriere

sponsor_collaborators:
Groupe Hospitalier Pitie-Salpetriere
Institut Curie

location_facility: AP-HP, Pitié-Salpêtrière Hospital, Department of Pharmacology, CIC-1421, Pharmacovigilance Unit, INSERM.


title: Exploratory Study of the Expression of the Serotonergic 5-HT4 Receptor in Parkinson's

acronym: PARK 5-HT4

summary: The research aim to study in detail the motor, cognitive and affective modifications of Parkinsonian patients (compared to control subjects) at a moderate stage of the disease and to analyze by positron emission tomography (PET) imaging with the specific radioligand [11C]SB207145 the expression levels of this 5-HT4 receptor. At the same time, the study will monitor the impact of the 5-HTTLPR polymorphisms of Serotonin Transporter (SERT) and Brain-derived neurotrophic factor (BDNF) Val66Met on the expression of the 5-HT4 receptor in subjects.

primary_purpose: Health Services Research

location_facility: Hôpital des Charpennes Centre de Recherche Clinique "Vieillissement-Cerveau-Fragilité"


title: An Open-Label Multicenter Phase 1b Study of Tolinapant (ASTX660) in Combination With Radiotherapy/Chemoradiotherapy (RT/CRT) in Preoperative Treatment of Patients With Rectum Cancer (PRAAR 1: Preoperative Radiotherapy And ASTX660 in Rectum Cancer)

summary:
Compare two arms:

Chemotherapy followed by tolinapant (ASTX660) in combination with Long-Course Radio Chemotherapy (LCRT), and
Tolinapant (ASTX660) in combination with Short-Course Radiotherapy (SCRT) followed by chemotherapy For each patient, the treatment arm will be allocated on the following basis: patients will be allocated to the chemotherapy followed by LCRT arm unless they present at least one of the following criteria: contraindication to receive mFOLFIRINOX (including intolerance to irinotecan and UGT1A1*28 polymorphism), age > 75, general condition incompatible with the radiotherapy schedule of LCRT. In such case, patients will be allocated to the SCRT arm.

Tolinapant (ASTX660) will be administered orally once a day for 7 consecutive days every other week during 10 weeks (One week On / One week Off during 10 weeks).

Both treatment arms will have a dose escalation part to determine the MTD and/or RP2D, followed by an expansion part where up to 21 subjects will be dosed at the RP2D. Both arms will enroll simultaneously.

lead_sponsor: Gustave Roussy, Cancer Campus, Grand Paris

location_facility:
Gustave Roussy
Centre Léon Bérard


title: The Effect of an Acute Bout of Physical Exercise on the Consolidation Phase of Motor Learning Acquired Through Physical or Mental Practice

acronym: EPICA

summary:
Motor learning is crucial for human daily routine, involving the acquisition of new movements. It consists of an online acquisition phase followed by offline consolidation, where motor memory is organized into stable representations. Acquisition can be achieved through physical practice (PP, overt repetition of movement) or mental rehearsal using motor imagery (MI). Recent studies suggest that high-intensity interval physical exercise (HIIE) enhances motor learning, particularly during consolidation, by promoting neural plasticity mediated by brain-derived neurotrophic factor (BDNF). However, the impact of HIIE on sequential motor consolidation with PP or MI remains poorly understood.

In contrast, sleep deprivation (SD) reduces BDNF release and neural plasticity. Limited research has explored the effects of SD on motor acquisition, especially sequential motor learning. Considering the opposing effects of HIIE and SD, performing HIIE after SD may protect motor consolidation processes.

This study aims to examine the influence of HIIE on sequential motor learning using PP or MI under both sleep-deprived and normal sleep conditions. Six groups, each comprising 12 participants, will learn an 8-item bimanual sequence.

MI group: acquired the motor sequence mentally during training
MI+HIIE group: acquired the motor sequence mentally and achieve a HIIE before the consolidation
PP: acquired the motor sequence physically
PP+HIIE group: acquired the motor sequence physically and achieve a HIIE before the consolidation
SD+PP group: one night of sleep deprivation prior physical motor acquisition with PP and consolidation
SD+PP+HIIE group: one night of sleep deprivation prior physical motor acquisition and HIIE before consolidation.

All groups will be tested on the sequence at the beginning and the end of the acquisition phase (pre- and post-acquisition), and after the physical exercise (i.e. HIIE) or the rest period (post-exercise).

Hypothesis of this study are :

Acute physical exercise (HIIE) would enhance the consolidation of motor memory (post-exercise) after physical and mental acquisition (PP,MI) compared to conditions without exercise.
One night of sleep deprivation would affect the acquisition and consolidation of motor learning.

Physical exercise would compensate for the detrimental effects of sleep deprivation on the consolidation of motor learning.

location_facility: Service d'explorations fonctionnelles respiratoires-Médecine du sport et de l'activité physique, Hôpital de la Croix-Rousse, Hospices Civils de Lyon


title: Sexuality After Tubal Sterilization by Conventional Abdominal Laparoscopy or Vaginal Natural Orifice Transluminal Endoscopy (vNOTES) : a Randomised Controlled Trial

acronym: TULIPES

summary: The goal of this clinical trial is compare the quality of sexual life at 6 months after tubal ligation, depending on whether it was performed by abdominal laparoscopy or by vNOTES, on the basis of a non-inferiority hypothesis. Participants will answer on the FSFI-19 questionnaire and quality of sexual life will be evaluated according to the score obtained at 6 months post-operative compared to pre-operative.

lead_sponsor: University Hospital, Clermont-Ferrand

location_facility:
CHU de Clermont-Ferrand
CH d'Issoire


title: Place of Copeptin-troponin Assay in the Elimination Diagnosis of Non-ST+ ACS in the Management of Pre-hospital and In-hospital Non-traumatic Chest Pain in Adults

acronym: CopSCA

summary: The aim of this study is to demonstrate that a combined troponin and copeptin assay can exclude non-ST+ ACS in patients with chest pain less than 6 hours old.

ReferenceCitation: Mockel M, Searle J, Muller R, Slagman A, Storchmann H, Oestereich P, Wyrwich W, Ale-Abaei A, Vollert JO, Koch M, Somasundaram R. Chief complaints in medical emergencies: do they relate to underlying disease and outcome? The Charite Emergency Medicine Study (CHARITEM). Eur J Emerg Med. 2013 Apr;20(2):103-8. doi: 10.1097/MEJ.0b013e328351e609.

ReferenceCitation: Fanaroff AC, Rymer JA, Goldstein SA, Simel DL, Newby LK. Does This Patient With Chest Pain Have Acute Coronary Syndrome?: The Rational Clinical Examination Systematic Review. JAMA. 2015 Nov 10;314(18):1955-65. doi: 10.1001/jama.2015.12735.

ReferenceCitation: Dawson C, Benger JR, Bayly G. Serial high-sensitivity troponin measurements for the rapid exclusion of acute myocardial infarction in low-risk patients. Emerg Med J. 2013 Jul;30(7):593-4. doi: 10.1136/emermed-2012-201574. Epub 2012 Jul 31.

ReferenceCitation: Khan SQ, Dhillon OS, O'Brien RJ, Struck J, Quinn PA, Morgenthaler NG, Squire IB, Davies JE, Bergmann A, Ng LL. C-terminal provasopressin (copeptin) as a novel and prognostic marker in acute myocardial infarction: Leicester Acute Myocardial Infarction Peptide (LAMP) study. Circulation. 2007 Apr 24;115(16):2103-10. doi: 10.1161/CIRCULATIONAHA.106.685503. Epub 2007 Apr 9.

ReferenceCitation: Kim KS, Suh GJ, Song SH, Jung YS, Kim T, Shin SM, Kang MW, Lee MS. Copeptin with high-sensitivity troponin at presentation is not inferior to serial troponin measurements for ruling out acute myocardial infarction. Clin Exp Emerg Med. 2020 Mar;7(1):35-42. doi: 10.15441/ceem.19.013. Epub 2020 Mar 31.

ReferenceCitation: Szarpak L, Lapinski M, Gasecka A, Pruc M, Drela WL, Koda M, Denegri A, Peacock FW, Jaguszewski MJ, Filipiak KJ. Performance of Copeptin for Early Diagnosis of Acute Coronary Syndromes: A Systematic Review and Meta-Analysis of 14,139 Patients. J Cardiovasc Dev Dis. 2021 Dec 27;9(1):6. doi: 10.3390/jcdd9010006.

ReferenceCitation: Aarts GWA, van der Wulp K, Camaro C. Pre-hospital point-of-care troponin measurement: a clinical example of its additional value. Neth Heart J. 2020 Oct;28(10):514-519. doi: 10.1007/s12471-020-01434-w.

ReferenceCitation: Kohn MA, Kwan E, Gupta M, Tabas JA. Prevalence of acute myocardial infarction and other serious diagnoses in patients presenting to an urban emergency department with chest pain. J Emerg Med. 2005 Nov;29(4):383-90. doi: 10.1016/j.jemermed.2005.04.010.

ReferenceCitation: Charpentier S, Beaune S, Joly LM, Khoury A, Duchateau FX, Briot R, Renaud B, Ageron FX; IRU Network. Management of chest pain in the French emergency healthcare system: the prospective observational EPIDOULTHO study. Eur J Emerg Med. 2018 Dec;25(6):404-410. doi: 10.1097/MEJ.0000000000000481.

ReferenceCitation: Hamm CW, Bassand JP, Agewall S, Bax J, Boersma E, Bueno H, Caso P, Dudek D, Gielen S, Huber K, Ohman M, Petrie MC, Sonntag F, Uva MS, Storey RF, Wijns W, Zahger D; ESC Committee for Practice Guidelines. ESC Guidelines for the management of acute coronary syndromes in patients presenting without persistent ST-segment elevation: The Task Force for the management of acute coronary syndromes (ACS) in patients presenting without persistent ST-segment elevation of the European Society of Cardiology (ESC). Eur Heart J. 2011 Dec;32(23):2999-3054. doi: 10.1093/eurheartj/ehr236. Epub 2011 Aug 26. No abstract available.

lead_sponsor: Hôpital NOVO

location_facility: Emergency Service - UHCD Hospital NOVO - Pontoise site

location_facility: Emergency Department (SAMU) Hospital NOVO - Pontoise site

intervention_type: Diagnostic Test


title: Technical Feasibility of the Cell-free DNA Test for Non-invasive Cytogenetic Analysis of Early Miscarriages Versus the Gold Standard Microarray

acronym: NICAEA

summary:
Among the 15% of couples who experience a spontaneous early miscarriage (SEM) during their pregnancy, approximately 2 to 5% will suffer from recurrent SEM. It is only after the third SM that they will be offered a workup to look for a predisposition to SEM. This workup does not currently include a search for foetal chromosomal abnormalities that could be considered causal for this event. These anomalies are responsible for approximately 50% of SEM and their detection could lead to an explanation for half of the couples currently without a diagnosis after a standard workup. The diagnosis of chromosomal abnormalities can be made by karyotype analysis or by Cytogenetic Microarray Analysis (CMA) on the product of conception. Unfortunately, karyotyping has a high failure rate due to poor cell culture of samples that are often degraded or of low quantity. The CMA is not always feasible due to the absence of analyzable feto-placental material linked to the use of a drug strategy for its elimination.

The study of cell-free DNA of syncytiotrophoblastic origin (cfDNA) circulating in the maternal plasma could be a solution as it is for non-invasive prenatal screening of trisomy 21. cfDNA is detectable from 6 to 8 weeks of amenorrhea and released in the maternal blood as long as placental tissue is present in the uterus, can be easily obtained by maternal venous sampling. If maternal blood sampling is performed before complete removal of the product of conception, then detection of foetal chromosomal abnormalities would be possible. Thus, if failure rates of CMA and cfDNA techniques are comparable, cfDNA could be preferred as it applies for miscarriages for whom no fetoplacental material can be obtained.

This study therefore proposes to compare the failure rates of the two technologies (CMA and cfDNA) for the detection of chromosomal abnormalities in recurrent SEM.

location_facility: Hopital Femme-Mère-Enfant; service gynécologie/obstétrique

location_facility: Hopital Femme-Mère-Enfant; service médecine de la reproduction


title: European Aortic Data Collection Project

acronym: EADC

summary:
The purpose of this study is to evaluate the safety and performance of Cook's various Custom-Made Stent-graft Devices (CMD) used for endovascular treatment of the aorta and related diseases by collecting information on the real-world use of the devices.

The study results will be used to support the continuation of the CMDs on the market. In addition, the study will support the manufacturers obligation for post market product surveillance as well as Cook's technology development.

lead_sponsor: Cook Research Incorporated

location_facility:
CHU de Lille
Hopital Marie Lannelongue


title: Safety, Tolerability and Gut microbIota AnalysiS of an Oral Microbiotherapy in Amyotrophic Lateral Sclerosis; an Open-label Phase 1b Pilot Trial

acronym: IASO

summary: The purpose of this pilot study is to assess the safety and tolerability of multiple doses of MaaT033 in ALS patients and to analyze the gut microbiota composition and evolution before considering a larger randomized controlled efficacy study.

lead_sponsor: MaaT Pharma

location_facility: Hôpital de la Pitié-Salpêtrière - CIC Neuroscience

location_facility: Centre Hospitalier Universitaire de Lille - CIC


title: Study of the Influence of Intraperitoneal Insufflation of Carbon Dioxide (CO2) by Laparoscopy on the Short-term Evolution of Premature Infants With Ulcerative Necrotizing Enterocolitis

summary:
Ulcerative-necrotizing enterocolitis (ECUN) is an infectious and inflammatory disease of the digestive tract, which can lead to intestinal necrosis or perforation.

This severe pathology of the newborn , often premature, requires urgent medical and surgical treatment in 25 to 50% of cases. The morbidity is high, both digestive and neurological. ECUN can lead to complications at short-term (death, intestinal stenosis) and at long-term (neuro-cognitive disorders). The challenge of preserving the neurological development is a major issue. It involves control of inflammation. This inflammation causes neurological lesions and is responsible for a disorder of the long-term neurocognitive development.

At Robert-Debré and Trousseau, the management of newborns with ECUN is focused on the control of this inflammation. A laparoscopy is performed first. The carbon dioxide (CO2) insufflated into the abdomen during a laparoscopy is thought to have an anti-inflammatory effect according to several experimental and clinical studies. A preliminary retrospective study at Robert-Debré showed a decrease in postoperative inflammation (decrease in C reactive protein at Day2 and Day 7 post-op) as well as a decrease in morbimortality (decrease in the rate of stoma and reoperation) in children who had a laparoscopic first operation compared to those who had a laparotomy alone. However, in many hospitals, laparotomy alone is currently the only surgical option.

This preliminary study may demonstrate that laparoscopy decreases early morbidity and mortality in children with ECUN through reduced inflammation, as reflected by postoperative C reactive protein.

lead_sponsor: Assistance Publique - Hôpitaux de Paris

location_facility: Hôpital Armand Trousseau Service de Chirurgie Pédiatrique et Néonatale

location_facility: Hôpital Robert Debré Service de Chirurgie Pédiatrique


title: Colchicine Versus Placebo in Acute Myocarditis Patients to Reduce Late Gadolinium Enhancement Mass on Cardiac Magnetic Resonance and the Risk of Clinical Outcomes: The ARGO Trial

acronym: ARGO

summary:
Myocarditis is an inflammatory disease of the heart, mostly caused by viruses. Patients with acute myocarditis are exposed to several complications: recurrence, ventricular arrhythmias (from 5 to 30%), heart failure (5-10%), death or heart transplantation (< 4%). To date, there is no specific treatment for myocarditis. Patient management only focuses upon empirical optimal care of arrhythmia and heart failure.

There is a strong rationale for using colchicine in acute myocarditis:

the IL1 (Interleukin1) pathway plays a detrimental role in acute myocarditis. NLRP3 (NOD-like receptor family, pyrin domain containing 3) inflammasome assembly, and subsequent IL-1beta production, are profoundly inhibited by colchicine.
colchicine has been shown to improve cardiac outcomes in inflammatory cardiac disorders, including pericarditis, coronary artery disease, and post pericardiotomy syndrome.
In murine model of CVB3-induced myocarditis (coxsackievirus B3), colchicine improved myocarditis through reduction of NLRP3 activity.
Small case series with improvement of left ejection fraction in myocarditis following low-dose colchicine in addition to conventional heart failure therapy have been reported.

With its pleiotropic anti-inflammatory effect in the pro-inflammatory cascade, reducing the myocardial damage and cell death induced during myocarditis, colchicine has the potential to reduce the risk of heart failure and ventricular arrhythmias. Finally, colchicine is a drug widely available, at low cost, and has a long and well-known safety record.

ReferenceCitation: Tschope C, Cooper LT, Torre-Amione G, Van Linthout S. Management of Myocarditis-Related Cardiomyopathy in Adults. Circ Res. 2019 May 24;124(11):1568-1583. doi: 10.1161/CIRCRESAHA.118.313578.

ReferenceCitation: Ammirati E, Cipriani M, Moro C, Raineri C, Pini D, Sormani P, Mantovani R, Varrenti M, Pedrotti P, Conca C, Mafrici A, Grosu A, Briguglia D, Guglielmetto S, Perego GB, Colombo S, Caico SI, Giannattasio C, Maestroni A, Carubelli V, Metra M, Lombardi C, Campodonico J, Agostoni P, Peretto G, Scelsi L, Turco A, Di Tano G, Campana C, Belloni A, Morandi F, Mortara A, Ciro A, Senni M, Gavazzi A, Frigerio M, Oliva F, Camici PG; Registro Lombardo delle Miocarditi. Clinical Presentation and Outcome in a Contemporary Cohort of Patients With Acute Myocarditis: Multicenter Lombardy Registry. Circulation. 2018 Sep 11;138(11):1088-1099. doi: 10.1161/CIRCULATIONAHA.118.035319.

ReferenceCitation: Kyto V, Sipila J, Rautava P. Rate and patient features associated with recurrence of acute myocarditis. Eur J Intern Med. 2014 Dec;25(10):946-50. doi: 10.1016/j.ejim.2014.11.001. Epub 2014 Nov 7.

ReferenceCitation: Peretto G, Sala S, Rizzo S, Palmisano A, Esposito A, De Cobelli F, Campochiaro C, De Luca G, Foppoli L, Dagna L, Thiene G, Basso C, Della Bella P. Ventricular Arrhythmias in Myocarditis: Characterization and Relationships With Myocardial Inflammation. J Am Coll Cardiol. 2020 Mar 10;75(9):1046-1057. doi: 10.1016/j.jacc.2020.01.036.

ReferenceCitation: Imazio M, Brucato A, Cemin R, Ferrua S, Maggiolini S, Beqaraj F, Demarie D, Forno D, Ferro S, Maestroni S, Belli R, Trinchero R, Spodick DH, Adler Y; ICAP Investigators. A randomized trial of colchicine for acute pericarditis. N Engl J Med. 2013 Oct 17;369(16):1522-8. doi: 10.1056/NEJMoa1208536. Epub 2013 Aug 31.

sponsor_collaborators:
Assistance Publique - Hôpitaux de Paris
Hospices Civils de Lyon
Fonds de Dotation ACTION

location_facility: Institut de Cardiologie - APHP Pitié Salpêtrière

location_facility: Unité de Soins Intensifs Cardiologiques - Hôpital Cardiovasculaire Louis Pradel


title: 6-month Evaluation of the Efficacy and Safety of Synolis VA 80/160 in the Treatment of Symptomatic Hip Osteoarthritis

summary: Multicenter, independent study of Synolis VA 80/160 over a period of 6 months

lead_sponsor: Aptissen SA

location_facility: Service de chirurgie orthopédique et traumatologie Centre Hospitalier de Dunkerque CHD

location_facility: Service d'Orthopédie II (Membre Inférieur, Chirurgie du Sport et Chirurgie Septique) Hôpital Salengro, CHRU de Lille


title: Feasibility sTudy to Assess the URoMems Artificial uriNary Sphincter In the Treatment of Stress Incontinence in wOmeN

summary: Prospective multicenter study designed to test the feasibility of the UroMems Artificial Urinary Sphincter in women

lead_sponsor: UroMems SAS

location_facility:
CHU Nantes
Groupe Hospitalier Pitié-Salpêtrière


title: Sleepiness in the Elderly: Validation of the Alternative Epworth Sleepiness Scale ESS-ALT in French

acronym: SOMNOLD

summary:
The Epworth Sleepiness Scale (ESS) is undoubtedly the most commonly used tool in daily clinical practice to assess daytime sleepiness in patients of all ages by means of a self-administered questionnaire.

In elderly subjects, the clinician is often confronted with difficulties in accurately estimating the ESS score and measuring subjective daytime sleepiness. Indeed, according to Onen et al, the ESS tends to underestimate the prevalence of sleep disorders in the geriatric population, mainly due to non-response to problematic items, namely:

Item 3: Sitting, inactive in a public place (cinema, theater, meeting)
Item 8: In a car that has been stopped for a few minutes.

In order to overcome this problem, Janine Gronewold's German team has developed and begun work on the validation of an alternative version of the ESS, the ESS-ALT, adapted to the population of interest, in German.

The aim of the present work is to adapt the ESS-ALT in French, then to study its correlation with sleep data recorded by nocturnal polysomnography, and among the secondary objectives, to correlate it with sleep latency during iterative sleep latency tests, in order to propose to the clinician a simple, reproducible tool, allowing to measure daytime sleepiness in elderly subjects.

status: Completed

study_completion_date_type: Actual

enrollment_type: Actual

location_facility: service des pathologies du sommeil, hôpital Pitié Salpêtrière

status_simplified: Completed


title: FLASH Study: Effectiveness and Safety of STYLAGE® HYDRO in the Treatment of Face, Neckline Area and Neck

acronym: FLASH

summary: FLASH Study is a Post-Market Follow-Up PCMF designed to evaluate the tolerance and efficacy of STYLAGE Hydro by using a satisfaction questionnaire.

lead_sponsor: Laboratoires Vivacy

location_facility:
Eurofins Dermscan Pharmascan
Eurofins Dermscan


title: Differential Diagnosis Between Parkinson's Disease and Multiple System Atrophy Using Digital Speech Analysis - Part 2 - Voice4PD-MSA-II

summary: Parkinson's disease (PD) is the second most common neurodegenerative disease. Multiple system atrophy (MSA) is a relentlessly progressing rare neurodegenerative disease of unknown etiology. The differential diagnosis between the MSA-Parkinsonism (MSA-P) subtype and PD can be very challenging in early disease stages, while early diagnostic certitude is important for the patient because of the diverging prognosis. At the time being, there exists no validated objective biomarker to guide the clinician. Dysarthria is a common early symptom in both diseases and of different origin. The ambition and the originality of this project are to develop a digital voice-based tool for objective discrimination between PD and MSA-P.

lead_sponsor: University Hospital, Bordeaux

collaborators: Institut National de Recherche en Informatique et en Automatique

location_facility: CHU de Bordeaux - Institut des maladies neurodégénératives de Bordeaux

location_facility: Centre Hospitalier Universitaire de Toulouse


title: CoHort of Patients to Identify Biological and Imaging markerS of CardiovascUlar Outcomes in ST Elevation Myocardial Infarction

acronym: HIBISCUS STEMI

summary:
ST-segment elevation myocardial infarction (STEMI) is an acute condition that accounts for 75% of sudden deaths in adults over 35 years of age and more than half of all cases of chronic heart failure. However, the mechanism of myocardial infarction remains poorly understood. At present, there is no national information system for myocardial infarction, as there is for other diseases such as multiple sclerosis (OFSEP cohort).

The purpose of this cohort is to enable studies and research projects to be carried out on the descriptive epidemiology of myocardial infarction, monitoring of patients undergoing treatment (safety, efficacy), quality of life and functional consequences of infarction, and research into new biological and imaging prognostic biomarkers. Its general objective is to provide researchers, hospital practitioners, medical interns, academics or industrialists with a quality epidemiological tool for research.

location_facility: Hospices Civils de Lyon - Hôpital de la Croix Rousse

location_facility: Hospices Civils de Lyon - Hôpital Louis Pradel


title: HYPNONAG : Therapeutic Communication Versus Traditional Method for Naso-gastric Intubation in Haematology: Randomized Controlled Clinical Study

acronym: HYPNONAG

summary:
Caloric intake is a determining factor in patients with hematological malignancies and hospitalized for prolonged aplasia following chemotherapy. The nutritional supplement is administered either parenterally or enterally through the placement of a nasogastric sonde (NGS). This last option has shown its advantage compared to parenteral nutrition in terms of preventing infections, the incidence of graft-versus-host disease in allograft patients, and the quality of resumption of oral nutrition during of returning home.

NGS allows the administration of an intake of 2000 calories/day, deemed necessary to mitigate the risk of undernutrition in patients hospitalized for more than 3 weeks and in the majority of cases unable to eat enough food mainly due to chemotherapy-induced mucositis. . The choice between enteral feeding by NGS and parenteral nutrition is the subject of controversial studies, with each team choosing one of the two options.

The installation of the NGS is often recognized as a traumatic gesture for patients but also invasive by caregivers.

The patient's anxiety, the intrusive and traumatic nature of the NGS can sometimes result in a failure of the gesture, a secondary refusal of the patient, or a reluctance of the caregiver to proceed with the gesture. Since 2013, NGS have been placed with the assistance of the nurse who practices hypnosis in the hematology department of the Rennes University Hospital. This invites the patient to pose his SNG without local anesthesia and in a completely autonomous way. The patient is thus able to place the NGS again if necessary during his hospitalization, and during subsequent hospitalizations. A retrospective and monocentric study carried out at the University Hospital of Rennes in 38 patients showed that all were able to perform NGS independently thanks to the hypnotic approach. It was observed a real comfort for the patient, and moreover this technique did not add extra work for the staff. The patient becomes autonomous and actor of his care.

lead_sponsor: Rennes University Hospital

location_facility:
Tours University Hospital
Rennes University Hospital


title: Environmental Mycobiota: In-depth Characterisation and Determinants Involved in Asthma Emission

acronym: MyCADO

summary:
The analysis of the exposome of severe asthmatic patients and its correlation with the response profile to biotherapies used in the treatment of severe asthma and/or the frequency of exacerbations, could make it possible to identify individual and environmental components influencing the evolution of the asthmatic pathology and/or response to treatment. An interventional approach could thus be developed, taking into account in particular the determinants of indoor air quality as well as the obstacles to the implementation of current recommendations for the prevention of exacerbations.

The patient will thus be returned to the center and considered as a main actor in his clinical history by offering him the most suitable intervention possible, according to the evaluation of his exposome, in order to ultimately reduce the morbidity and mortality linked to exacerbations.

This interventional approach could then be validated on a larger scale in a national multicenter study involving a larger number of patients.

sponsor_collaborators:
University Hospital, Bordeaux
University of Bordeaux

location_facility:
University Hospital, Bordeaux
University Hospital, Toulouse


title: Diagnostic Performance of a Commercial Indirect Immunofluorescence Assay for the Detection of Neuronal Antibodies in Auto-immune Encephalitis and Paraneoplastic Neurological Syndromes

acronym: IFINEURO

summary:
Detection of autoantibodies targeting neuronal surface or intracellular antigens is a keystone for the diagnosis and the treatment of auto-immune encephalitis and paraneoplastic neurological syndromes. A strategy commonly used for their detection is to perform a screening with a tissue-based immunofluorescence assay or immunohistochemistry assay and a second line test to confirm and identify the autoantibody. Since several years, commercial kits are used by a growing number of laboratories to screen the presence of these autoantibodies. However, the diagnostic performance of these commercial kits is highly variable and several studies reported a high prevalence of false-positive and false-negative results with commercial immunodots and cell-based assays. It is therefore essential to explore commercial kits limitations in order to avoid false-positive and false-negative results that could lead to misdiagnosis and/or to delay the treatments.

To assess the diagnostic performance of commercial kits, the investigators performed a prospective study in which the investigators screened patients neuronal autoantibodies in cerebrospinal fluid and sera using commercial tissue-based indirect immunofluorescence assay and CBAs in comparison with an in-house tissue-based indirect immunofluorescence assay.

location_facility:
Hospices Civils de Lyon
Hospice Civils de Lyon


title: Bioactive Dairy Lipids to Manage Cardiometabolic Risk in Obesity

acronym: DAILICATE

summary:
It is a randomized parallel arm intervention study in adults with severe obesity. The objective is to demonstrate that within a dietary handling for weight loss, the daily ingestion during 3 months of whole dairy products enriched with milk polar lipids or whole dairy products decreases to a greater extent fasting plasma apolipoprotein B concentrations than the daily ingestion of low-fat dairy products (control group).

Metabolic parameters will be assessed before and after the 3-month intervention, both at fasting and in postprandial period after the consumption of standardized meals.

collaborators: Laboratoire de Recherche en Cardiovasculaire, Métabolisme, Diabétologie et Nutrition

collaborators: Centre de Recherche en Nutrition Humaine Rhone-Alpe

collaborators: Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement

location_facility: Centres Hospitalier Lyon Sud, Service d'Endocrinologie-Diabète-Nutrition

location_facility: Centre de Recherche en Nutrition Humaine Rhône-Alpes


title: Study of Lipid Balance in Adult Sickle Cell SS or SC Patients at Steady State and According to Clinical Phenotypes and During Acute Complications Acronym : "HDL2"

summary: This study aims to describe and/or searches for, in cohorts of adult sickle cell anemia (SCA) and SC sickle cell patients living in the French West Indies and followed by SCD Reference and Competence Centers: 1-lipids profiles and associations at steady state with occurrence of sickle cell disease (SCD) complications, 2-lipids profile evolution during and after prospective acute complications (vasoocclusive crises (VOC) and priapism), 3-lipids profile variation (inter /intra individuals) during 4 prospective years, 4- Genetic primary modulators of SCD complications, 5- insulin resistance (HOMA), free fatty acids and glycerol dosages, 6- lipids enzymes, lipidome and functionality of HDL in sub-groups of SCD population.

lead_sponsor: Centre Hospitalier Universitaire de Pointe-a-Pitre

location_facility:
Centre de Référence de la Drépanocytose
Unité Transversale de la Drépanocytose


title: Multicentric Comparative Prospective Study of the Benefits and Risks of Biopsy Prostate Using Transrectal or Transperineal Procedure for the Prostate Cancer Diagnostic.

acronym: BIOPROSTABORD

summary:
The performance of prostatic biopsies is an essential element to confirm the diagnosis of prostate cancer and to specify the characteristics of the tumor in terms of stage and grade.

The first route of prostatic biopsies is mainly transrectal with passage of a needle introduced into the guide fixed on the endorectal ultrasound probe. There is another possible access route, transperineal, with prostatic puncture by a needle introduced transcutaneously, guided by an endorectal ultrasound image. The first transperineal route would offer the first benefit for the patient, to reduce the infectious risk inherent in the endorectal way. It would also reduce the risk of rectal bleeding.

In addition, the transperineal pathway appears to be able to improve the detection threshold of prostatic tumours located on the anterior part of the gland due to the angle of penetration of the needle and its more anterior positioning relative to the prostate.

There is currently no randomized comparison study of the transperineal versus transrectal procedure on infectious risk. The aim of the project is to enable this comparative study, within our institution where experienced urologist surgeons practice.

lead_sponsor: Elsan

location_facility:
Centre Médico-Chirurgical Les Cèdres
Clinique St Augustin


title: Validation of a Screening Scale for the Misuse of Opioid Analgesics in Patients With Chronic Pain Related to Cancer.

acronym: VPOMIONCOL

summary:
In oncology, pain is one of the main symptoms of discomfort. It has a significant impact on the quality of life.The use of opioid analgesics is recommended for the treatment of moderate to severe cancer pain.The misuse of opioid analgesics is an international public health problem.Different scales have been developed to help the prescriber screen for the risk of misuse in the general population. Patients with cancer-related pain are also at risk for aberrant opioid-related behaviors, misuse or addiction.

The main objectif of this study is to validate of the screening scale for the misuse of opioid analgesics in patients with chronic pain related to cancer. (Prescription Opioid Misuse Index - POMI).

location_facility:
CH Le Puy en Velay
CHU de Clermont-Ferrand


title: Description of Septic Thrombophlebitis on Central Venous Catheter and Midline

acronym: THROMBOSEP

summary:
Central venous catheters improve the tolerability and feasibility of patient care in the hospital setting by allowing the administration of hyper-osmotic, vesicant and venotoxic fluids. Despite these advantages, the long-term presence of central venous catheters is associated with thrombotic and infectious risks , including catheter-related bacteremia, which can be complicated by septic thrombophlebitis and endocarditis that can lead to death.

Septic thrombophlebitis is a complication of venous catheter infections, which increases the morbidity. It is defined by the presence of a thrombosis in the vein where the venous catheter is located, associated with a bacteremia. A distinction is made between superficial and deep thrombophlebitis.

The frequency of septic thrombophlebitis of venous catheters is variable and poorly described in the literature.

When the diagnosis of septic thrombophlebitis is made, it is recommended to extend the duration of antibiotic therapy, to remove the infected catheter and to prescribe anticoagulant treatment. However, there is no recommendation on the duration of anticoagulation for septic thrombophlebitis, whether it is deep or superficial.

Investigator proposes a prospective and descriptive interventional study to describe the ultrasound evolution of thrombus in patients with septic thrombophlebitis on central venous catheter and midline.

lead_sponsor: Centre Hospitalier le Mans

location_facility:
Centre Hospitalier Le Mans
CHU Angers


title: Thymoglobulin® Pharmacokinetics for Graft-versus Host Disease in Children and Adults Undergoing Hematopoietic Stem Cell Transplantation

acronym: PHASAL-GA

summary:
Thymoglobulin is widely applied as serotherapy in order to prevent acute graft-versus-host disease (GvHD) and graft rejection in patients undergoing non-Human Leukocyte Antigen (HLA)-identical hematopoietic stem cell transplantations (HSCT), with a delicate balance between prevention of GvHD and the promotion of immune reconstitution. Thymoglobulin is known as a drug with high pharmacokinetic (PK) variability. This variability influences drug exposure, which in turn determines the drug response of pharmacodynamics (PD). In order to maintain efficacy while reducing adverse effects of drugs across the entire age range, identification of the PK/PD relationships and the effect of growth and maturation on the different PK and PD parameters involved are crucial.

The investigators hypothesise that a better knowledge of Thymoglobulin PK and its covariates would help to individualise dosage regimen and would improve clinical outcomes, such as GvHD and immune reconstitution.

The investigators aim to build a population PK model of Thymoglobulin in order to study PK variability and its covariates. This model will help in optimizing dosage regimen in an individually way.

lead_sponsor: Hospices Civils de Lyon

location_facility: Institut d'Hématologie et d'Oncologie Pédiatrique


title: Rheumatoid Purpura in Children: a Multicenter Observational Study of Pediatric Emergency Department Management and Follow-up by Primary Care Physicians

acronym: PREEMS

summary: The main objective of this study is to describe the management of children with rheumatoid purpura from admission to the pediatric emergency room to follow-up by primary care physicians after hospital discharge.

lead_sponsor: Groupe Hospitalier de la Region de Mulhouse et Sud Alsace

location_facility:
Hôpital de Hautepierre
Hôpitaux Civils de Colmar


title: Exploratory Study on the Role of the Digestive Microbiota and Bacterial Translocation in the Immune Activation Profile Associated With Insulin Resistance in Male Caucasian Adults Living With HIV-1 on Effective Antiretroviral Therapy.

acronym: MICRACTIVIH

summary:
Chronic immune activation present in aviremic people living with HIV under treatment promotes the onset of insulin resistance and metabolic syndrome, paving the way for the comorbidities that are currently the main causes of morbidity. This activation continues despite effective antiretroviral therapy. In the ACTIVIH study (NCT02334943) the analysis of 68 AI markers allowed classification of 120 aviremic PLHIV under treatment for at least 2 years according to 5 different immune activation profiles. Among these 5 profiles, Profile 2 was characterized by high blood pressure figures, high waist sizes, low HDL-cholesterol levels, high triglyceridemia, and especially hyperinsulinemia. Several studies have shown that the digestive microbiota of this population is less rich and less diverse than that of healthy subjects. However, the digestive microbiota and in particular bacterial proteins and metabolites seem to play a key role in immune activation in people living with HIV. Finally, the digestive microbiota has already been shown to have an impact on insulin sensitivity.

The study investigators hypothesize that a particular digestive microbiota could promote the appearance of Profile 2. This microbiota could be the cause of digestive dysbiosis leading to intestinal inflammation, digestive permeability and bacterial translocation.

status: Withdrawn

lead_sponsor: Centre Hospitalier Universitaire de Nīmes

location_facility:
CHU Gui de Chauliac
CHU de Nîmes

status_simplified: Unknown


title: NEO - E-vita Open Neo Treatment of Aortic Arch Aneurysms and Dissections

acronym: NEO

summary:
Observational, prospective/retrospective, non-randomised, non-comparative, multicentre cohort study.

Primary objective is evaluation of in-hospital all-cause mortality after treatment of extensive acute and chronic aortic pathologies with E-vita OPEN NEO.

lead_sponsor: JOTEC GmbH

sponsor_collaborators:
JOTEC GmbH
ICON plc

location_facility:
CHU le Bocage - CHU de Dijon
Centre Hospitalo-Universitaire d'Angers


title: Verification of the Performance and Safety of the First Row Resorbable Threaded Anchor FIXIT® in Arthroscopic Rotator Cuff Repair as Part of the Post-marketing Follow-up of Device

summary: Verification of the performance and safety of the first row resorbable threaded anchor FIXIT® in arthroscopic rotator cuff repair Non-interventional, prospective, non-comparative, multi-center study as part of the post-marketing follow-up of devices

lead_sponsor: Science and biomaterials

location_facility:
CH Purpan
Polyclinique de l'Ormeau


title: Modification de la Posture et Appareillage Auditif Dans la Presbyacousie

acronym: Post-AP

summary: Presbycusis could be associated to increased risk to fall. There is little about the impact on postural balance of hearing aids. In this study, the investigators describe the postural balance evolution before and after hearing aid fitting in presbycusis-affected adults (55-80years old) consulting Angers University Hospital ENT department and ENT Medical Doctor of Le Mans .

ipd_sharing_description: anonimized data within elliptic surface of posturography, PTA, and self reported dissiness

lead_sponsor: University Hospital, Angers

location_facility:
Dr Lorin's otholaryngology practice
UH Angers


title: Monitoring of the End-tidal Carbon Dioxide (EtCO2 ) as a Severity Criterion in COPD Exacerbations: a Prospective Observational Study

summary: Although we know that these numbers are underestimated, Chronic obstructive pulmonary disease (COPD) is a common chronic respiratory disease that affects between 8 and 12% of adults. According to a 2020 WHO report, it is the third most common cause of mortality in developed countries. This disease is punctuated by exacerbations associated with an 8% mortality of hospitalized patients, increased to 24% when the patient is admitted to intensive care unit. Early detection and treatment of these exacerbations appears to be essential to improve patient survival. End-tidal carbon dioxide (EtCO2) is used to assess a patient's respiratory and hemodynamic status. Indeed, EtCO2 is a non-invasive measure that could allow the estimation of arterial carbon dioxide (PaCO2) without performing blood gases, an arterial blood sampling, classically at the radial artery. This study aimed to find an EtCO2 value which at the time of the initial management, would be predictive of a severe COPD exacerbation, as well as PaCO2.

ReferenceCitation: Molinari N, Briand C, Vachier I, Malafaye N, Aubas P, Georgescu V, Roche N, Chanez P, Bourdin A. Hospitalizations for COPD Exacerbations: Trends and Determinants of Death. COPD. 2015;12(6):621-7. doi: 10.3109/15412555.2015.1007931. Epub 2015 Aug 11.

ReferenceCitation: Wang J, Zhang J, Liu Y, Shang H, Peng L, Cui Z. Relationship between end-tidal carbon dioxide and arterial carbon dioxide in critically ill patients on mechanical ventilation: A cross-sectional study. Medicine (Baltimore). 2021 Aug 20;100(33):e26973. doi: 10.1097/MD.0000000000026973.

ReferenceCitation: Kartal M, Goksu E, Eray O, Isik S, Sayrac AV, Yigit OE, Rinnert S. The value of ETCO2 measurement for COPD patients in the emergency department. Eur J Emerg Med. 2011 Feb;18(1):9-12. doi: 10.1097/MEJ.0b013e328337b9b9.

ReferenceCitation: Jabre P, Jacob L, Auger H, Jaulin C, Monribot M, Aurore A, Margenet A, Marty J, Combes X. Capnography monitoring in nonintubated patients with respiratory distress. Am J Emerg Med. 2009 Nov;27(9):1056-9. doi: 10.1016/j.ajem.2008.08.017.

ReferenceCitation: Dogan NO, Sener A, Gunaydin GP, Icme F, Celik GK, Kavakli HS, Temrel TA. The accuracy of mainstream end-tidal carbon dioxide levels to predict the severity of chronic obstructive pulmonary disease exacerbations presented to the ED. Am J Emerg Med. 2014 May;32(5):408-11. doi: 10.1016/j.ajem.2014.01.001. Epub 2014 Jan 15.

ReferenceCitation: Tyagi D, Govindagoudar MB, Jakka S, Chandra S, Chaudhry D. Correlation of PaCO2 and ETCO2 in COPD Patients with Exacerbation on Mechanical Ventilation. Indian J Crit Care Med. 2021 Mar;25(3):305-309. doi: 10.5005/jp-journals-10071-23762.

ReferenceCitation: Gamble C, Krishan A, Stocken D, Lewis S, Juszczak E, Dore C, Williamson PR, Altman DG, Montgomery A, Lim P, Berlin J, Senn S, Day S, Barbachano Y, Loder E. Guidelines for the Content of Statistical Analysis Plans in Clinical Trials. JAMA. 2017 Dec 19;318(23):2337-2343. doi: 10.1001/jama.2017.18556.

ReferenceCitation: Bossuyt PM, Reitsma JB, Bruns DE, Gatsonis CA, Glasziou PP, Irwig L, Lijmer JG, Moher D, Rennie D, de Vet HC, Kressel HY, Rifai N, Golub RM, Altman DG, Hooft L, Korevaar DA, Cohen JF; STARD Group. STARD 2015: an updated list of essential items for reporting diagnostic accuracy studies. BMJ. 2015 Oct 28;351:h5527. doi: 10.1136/bmj.h5527.

ReferenceCitation: Lin LI. A concordance correlation coefficient to evaluate reproducibility. Biometrics. 1989 Mar;45(1):255-68.

ipd_sharing_description:
The international writing and publication rules (The Uniform Requirements for Manuscripts of the ICMJE, April 2010) will be followed. The minimum anonymized source data for performing the statistical analysis will be made public at the time of publication, with the article, or deposited in an appropriate public database. Other anonymized data may be available from the principal investigator upon reasonable request and with the consent of the sponsor.

In accordance with the French law n ° 2002-303 of March 4th, 2002, the subjects can be informed, at their request, of the overall results of the research. In this study, the investigators commit to individually communicating the overall results to each subject participating in the research by a short (popularized) summary and associated with a copy of the scientific article.

lead_sponsor: University Hospital, Grenoble

sponsor_collaborators:
University Hospital, Grenoble
Hospices Civils de Lyon

location_facility:
CHU Grenoble Alpes
Hospices Civils de Lyon


title: Multicenter, Uncontrolled Pilot Study Evaluating the Efficacy of Eculizumab in the Treatment of Gemcitabine-induced Thrombotic Microangiopathies

acronym: GEMECULI

summary: The main objective of this prospective multisite trial is to study the evolution of TMA (thrombotic microangiopathy) induced by gemcitabin and treated by eculizumab.

lead_sponsor: University Hospital, Rouen

location_facility:
Rouen University Hospital
Amiens University Hospital


title: Interest of Tecartherapy on a Painful Caesarean Section Scar: a Randomized Clinical Trial.

acronym: NOCEPAIN

summary:
Cesareans are a frequent procedure in obstetrics and 15.4% (95% CI, 9.9-20.9%) of women with cesareans still have pain at 3 months after delivery. Currently, self-massage of the scar is recommended to them. Post-cesarean pain is associated with psychological disorders (including, e.g., anxiety, depression). Tecar therapy could improve the healing and pain associated with cesareans and therefore improve women's quality of life and their satisfaction.

Objectives: The principal objective is to study the analgesic efficacy of tecar therapy for postoperative scar pain and/or discomfort at 3 month after cesarean delivery, by comparing it with sham tecar therapy.

A randomized clinical trial with 2 parallel arms and single blinding, to study the efficacy of this medical device for therapeutic purposes. In both groups (randomization stratified as a first cesarean or repeat cesarean), the women will have the standard recommended treatment - manual self-massage of the scar. Women's instruction in this self-massage will be structured and identical for both groups, including the provision of an informational document describing how to perform this massage. The training will be provided immediately after randomization.

Description of the experimental group These women will receive Tecar through Winback® technology [CE medical 1984, Norma 60601-2, ISO9001, ISO13485. Class IIa medical device, CET (capacitative mode) 400 VA and RET (resistant mode) 100 Watts, weight 4 Kg)]. Each session will last for 20 minutes, and each individual will have 3 sessions over a period of 3 weeks.
Description of the control group ("sham treatment") The women will follow the same study design as the experimental group with activation of the portable placebo device identical to the active medical. Each session will last for 20 minutes, and each individual will have 3 sessions over a 3-week period.

Principal endpoint: Visual analogic scale (VAS) for pain and/or discomfort at 3 months after delivery partum (with a ruler scored from 0 for no pain to 10 for the worst pain imaginable).

Succinct description of the products: "Tecar" is an acronym for a type of therapy (transfer electrical capacitive and resistive). The Winback® is a portable, easy-to-handle noninvasive regenerator. This study will use only the instrumental mode and 4-cm electrodes. During each session, this electrode will be moved over the entire scar. We will use the following 3 modes: capacitive (CET), CET Dynamic, and resistant (RET). These allow us to standardize the treatment without taking into account either the thickness of the abdominal wall or the woman's morphology. Each session will take 20 minutes (CET for 4 min, CET Dynamic 6 min, RET 6 min and CET 4 min). The intensity of CET and RET will be adapted to each woman and the diathermy chosen according to the woman's threshold of comfort, to be determined by her at each session, in the experimental group. There will be 1 session a week for 3 weeks.

Study plan and procedures: The eligible women will be identified by the physicians in both of the obstetrics departments participating in this study. The women will receive oral information as well as written information. If they are interested, they will be offered an inclusion visit, normally scheduled for one week later. After a second verification of the eligibility criteria at this inclusion meeting, reading the information form and signing the consent, they will be randomized into one of the two groups by random drawing. Each woman will have 3 sessions (1 session a week for 20 min for 3 consecutive weeks): active treatment by tecar therapy or sham/placebo tecar therapy. They will receive self-administered questionnaires at 3 and 6 months after delivery to be completed and returned.

lead_sponsor: University Hospital, Clermont-Ferrand

location_facility:
CH de Vichy
CHU clermont-ferrand


title: Quattro® X Suture Anchor With BroadBand™ Tape Post Market Clinical Follow-up Study (Incl. Instruments)

summary:
The study is a multicenter, retrospective and prospective, non-randomized, noncontrolled, and consecutive series post-market study. The purpose of this study is collect data confirming safety, performance and clinical benefits of the Quattro® X Suture Anchor with BroadBand™ Tape and Instruments when used in rotator cuff repair.

The primary endpoint of this study is the assessment of performance by analyzing soft tissue to bone healing in the shoulder (rotator cuff). Healing will be assessed by the investigator using PROMs and clinical outcomes of the patient. The clinical benefit will be assessed by functional outcomes measured using standard and well-established scoring systems (e.g. Constant & Murley and EQ-5D-5L) at 1 year post-operative.

The safety will be assessed by monitoring the incidence and frequency of device- and/or procedure-related adverse events.

lead_sponsor: Zimmer Biomet

location_facility:
Ortheo
Centre Clinical


title: Evaluation of Long-term Outcomes on Urinary Continence, Fecal Continence, Sexuality and Quality of Life of Patients Treated for Bladder Exstrophy by Questionnaires.

acronym: QUALEXSTRO

summary:
The bladder exstrophy epispadias complex (BEEC) is a rare spectrum of congenital conditions due to abnormal development of the cloacal membrane. Of these conditions, bladder exstrophy (BE) represent a mild form and requires several complex surgical corrections to gain access to a urinary and fecal acceptable continence and a normal sexual function at adulthood. Despite the surgeries, patients may suffer, in the long term, from functional impairments (incontinence, sexuality disorders) which can impact severely their quality of life. However, only a few studies investigate long term issues of bladder exstrophy patients, with heterogenous population and small samples.

The department of pediatric surgery of the Hospices Civils of Lyon is an expert center in the management of patients born with bladder exstrophy. At adulthood, departments of adult urology continue the follow-up and treat residual complications. Thus, a large cohort of adults and adolescents' patients with bladder exstrophy is currently followed at our institution.

Therefore, the aim of this study is to evaluate urinary continence, fecal continence, sexuality and quality of life among a large cohort of patients treated for bladder exstrophy, using questionnaires.

All patients over 15 years old and treated for bladder exstrophy at our institution are included in the study. Exclusion's criteria are : patients treated for epispadias or cloacal exstrophy, patients initially treated of their bladder exstrophy abroad with no access to the surgical report, patients under a guardianship measure. All included patients are contacted by e-mail or phone to answer the questionnaire. The purpose of statistical analysis is to evaluate the average score in each field of investigation:

Mean ICIQ score for urinary continence
Mean FLQI score for fecal continence
Mean FSFI score for sexuality in women
Mean IIEF-5 score for sexuality in men
Mean SF-12 score for quality of life, in comparison of mean SF-12 score in general French population based on literature

Secondary objectives are to assess the impact of different surgical strategies used for bladder exstrophy reparation on urinary continence, fecal continence, sexuality and quality of life ; to describe the population from a sociological point of view (level of study, profession, marital status) and to describe the population reproductive status (pregnancy, delivery modalities, paternity and maternity status, use of medically assisted procreation).

location_facility:
Hôpital Femme Mère Enfant
Hôpital Femme mère et enfant


title: A Post-market Clinical Follow-up (PMCF) Study to Evaluate Clinical, Radiographic and Patient Reported Outcomes Following a Hip Hemiarthroplasty Surgery Using Corin Devices

summary: This PMCF study is designed to collect safety and efficacy data on hip hemiarthroplasty surgeries with Corin BiPolar-i shell and the Oceane+ or Meije Duo femoral stem up to 10 years.

lead_sponsor: Corin

location_facility:
Hopital Saint Joseph
Polyclinique Henin Beaumont


title: Early Return of COVID-19 Patients to Home on Oxygen: Evaluation of a New Strategy Based on the City/Hospital Link

acronym: COVAMBU

summary:
The René Dubos Hospital in Pontoise has set up a home discharge system for oxygen-requiring patients in collaboration with PRADO, a health insurance organization, or private providers. This organization coordinates the care to be implemented at home based on the city/hospital link. The coordinator of this organization was also in charge of scheduling a follow-up consultation between 7 and 14 days after hospital discharge.

The aim of this study is to evaluate this new organization, both in terms of its impact on patient outcomes (survival and re-hospitalization rates) and on patients' experiences and satisfaction with their care.

lead_sponsor: Hôpital NOVO

location_facility: Aval-emergency medicine department - Infectious diseases departement- Hospital René Dubos Pontoise

location_facility: Polyvalent, infectious and pulmonary medicine - GHCPO Beaumont/Oise


title: Perceptions,Social Representations and Experience of Lyme Borreliosis and Ticks in Adolescents Likely to be Infected and Their Parents

acronym: ADO-LY

summary:
the study is offered to adolescents aged 12 to 17 and their families suspected of or suffering from Lyme barilliosis.

During inclusion, three interviews will be carried out for each family. This choice of the number of interviews per family seems the most appropriate to have a plurality of answers to the questions asked. Thus, these will have a duration of 30 min to 1 hour and will be carried out by an anthropologist. The first interview will be with the teenager. The second interview will then concern the parent(s). Finally, the last appointment will be with the teenager and his parents.

lead_sponsor: Centre Hospitalier Intercommunal Creteil

location_facility: Centre Hospitalier Intercommunal Villeneuve Saint Georges


title: Translate Title: Evaluation of the Efficacy of Two Guidance Techniques (Standard Injected CT vs Porto-scanner With Angio-CT) for Thermoablation Treatment of Colorectal Cancer Liver Metastases: Randomized, Single-blind, Controlled Study

acronym: MARGIN

summary:
Hepatic metastases of colorectal cancer (CRC) are partially necrotic tumors mainly vascularized by the hepatic artery. When resectable, these metastases must be removed with a safety margin of 1 mm. Resection margins greater than 1 cm are associated with better disease-free survival and no local recurrence. Thermoablation systems allow for ablation zones of approximately 4.5-5 cm in diameter. For tumors <3 cm, subject to perfect targeting, it is possible to obtain ablation margins of 1 cm, which would greatly reduce the local recurrence rate. Accurate assessment of these tumor boundaries and characterization of these margins are paramount to ensure complete ablation.

Thermoablation for these small liver metastases (<3cm) has shown equivalent efficacy to surgery in terms of recurrence and survival with fewer complications. Thermoablation treatment is indicated for patients with stable disease undergoing chemotherapy. This leads to liver remodeling and metastases become difficult to see on ultrasound and CT scans. The study authors hypothesize that the porto-scanner guidance technique with Angio-CT for thermoablation treatment of CRC liver metastases will allow a better exploration of these metastases by allowing a better identification of the margins and thus ensure a more accurate and complete treatment for patients.

sponsor_collaborators: Centre Hospitalier Universitaire de Nīmes

location_facility:
CHU de Montpellier
CHU de Nîmes


title: Deformity of the Forefoot in Children With Unilateral Cerebral Palsy

acronym: Mediopied-PC

summary: Midfoot and backfoot deformities are well described in children with Cerebral palsy. However, data regarding forefoot deformities in Cerebral palsy remain scarce in a population were foot deformities are the most frequent musculo-skeletal deformities.

lead_sponsor: University Hospital, Brest

location_facility: PRIGENT Houx


title: Impact on the Use of Antibiotics of a Multimodal Algorithm for the Diagnosis and Management of Acute Community-acquired Pneumonia in the Emergency Room

acronym: PROMCAP

summary:
Reducing antibiotics prescription is still to date, the main goal in low respiratory tract infections (LRTI).

Several studies have shown conflicting results on the impact of multiplex PCR as a point of care tool. Our experience has highlighted an impact on single room assignments during the winter season but not yet on antibiotics prescriptions. This project aims to evaluate a new multimodal algorithm including multiplex PCR at the point of care to reduce antibiotics prescription and therefore has the ability to have a positive impact on antibiotics resistance phenomenon.

lead_sponsor: Assistance Publique - Hôpitaux de Paris

sponsor_collaborators:
Assistance Publique - Hôpitaux de Paris
QIAGEN Gaithersburg, Inc

location_facility:
CHU Nîmes
Bichat hospital


title: Evaluation of Vascular Toxicity of Immune Checkpoint Inhibitors (Nivolumab, Pembrolizumab, Atezolizumab) in Patients Head and Neck or Lung Cancer

acronym: IMMUNOVASC

summary:
Since the introduction of immune checkpoint ihibitors (ICIs) in cancer treatment, numerous studies have investigated different patient profiles to identify those who benefit from this class of drugs. Currently, hundreds of studies are being conducted with the aim of increasing the benefit of these therapies by combining ICIs with other treatments: immunomodulators, cytotoxics, targeted therapies, including cancer vaccines, which are peptides or RNA injected to trigger or increase a specific immune response against the tumor. Other approaches exist, such as oncology-specific "basket" studies, to focus on a genetic mutation independently of tumor location and determine whether a drug could treat the same genetic mutation found in several different locations. To date, ICIs are part of standard management in the US for patients with several diseases: advanced melanoma, NSCLC, Merkel cell carcinoma, head and neck squamous cell carcinoma, urothelial and renal cell carcinoma, cancers characterized by microsatellite instability, refractory Hodgkin's lymphoma, hepatocellular carcinoma, gastric cancer. In addition, trials are underway to investigate the benefit of ICIs in other locations.

Thus, taking into account the growing importance of ICIs in the oncological therapeutic strategy and the large number of patients treated, a better understanding of the vascular impact of these drugs is necessary.

lead_sponsor: Centre Henri Becquerel

location_facility:
Centre Henri Becquerel
CHU Rouen


title: Prospective Clinical Investigation on the Evaluation of Performance and Safety of the EPIONE Assisted CT-guided Percutaneous Procedures in the Lungs

acronym: EGLE

summary: Interventional clinical study to obtain performance and safety data of the EPIONE® device when used for percutaneous procedures in the lung.

status: Active, not recruiting

lead_sponsor: Quantum Surgical

location_facility:
Gustave Roussy Institut
Hôpital La Timone


title: Effectiveness of an Intervention Combining Adapted Physical Activity and Therapeutic Education in Patients With Chronic Symptoms Attributed to Lyme Borreliosis. Multicenter, Controlled, Randomized Pilot Study

acronym: LyMouv'

summary: Lyme borreliosis, commonly known as Lyme disease, has been clinically described for more than a century, but has been officially recognized for 40 years, with the detection of the Borrelia bacterium by W. Burgdorfer, in ticks of the Ixodes ricinus complex, identified a few years before.

lead_sponsor: Centre Hospitalier Universitaire de Saint Etienne

location_facility:
CHU Clermont-Ferrand
Chu Saint Etienne

appel_a_projets: PREPS

region: Auvergne-Rhône-Alpes

nom_etablissement: CHU DE SAINT-ETIENNE

type_etablissement: CH

acronyme: LyMouv'

titre: Efficacité d'une organisation de soins optimisée chez des patients présentant des symptômes chroniques après et/ou attribués à une borréliose de Lyme.Étude interventionnelle visant à modifier les comportements en termes d'activité physique et de sédentarité. L'étude LyMouv'. Étude multicentrique randomisée en stepped-wedge

discipline_principale: organisation des soins

nom_porteur: HUPIN

prenom_porteur: David


title: An Exploratory, Comparative and Multicentric Study, to Evaluate the Effect of the RV3278A - ET0943 on the Host/Micro-organism Relationships in Acneic Subjects

summary: The aim of the study is to understand the structural and functional modifications of the host, the microorganisms, and their interactions (host/microorganism relationship) before and after the RV3278A - ET0943 product application

lead_sponsor: Pierre Fabre Dermo Cosmetique

location_facility:
Centre de santé SABOURAUD C.E.P.C
Centre de Recherche sur la Peau


title: Pilot Study Before/After of Vagal Stimulation in Chronic Low Back Pain

acronym: VALOM

summary:
Low back pain is a major public health problem. It is the leading cause of disability in the world. The factors that lead to chronicity of low back pain are multi-factorial and are essentially represented by psychosocial factors (catastrophism, kinesiophobia, algophobia job dissatisfaction, emotional problems such as depression, anxiety, stress, injustice, etc.).

Pain is a multimodal experience that involves different brain structures that are activated by the pain signal and involve the autonomic nervous system (ANS). The vagus nerve is the main actor of one of the two branches of the ANS, the parasympathetic system, which acts as a "slow-down".

The vagus nerve participates in the inter-neuronal transmission of key neurotransmitters for mood, alertness, attention and motivation.

Vagal stimulation has been used for many years as an analgesic device in chronic pain (vascular pain (facial vascular pain, fibromyalgia, visceral pain, gastrointestinal and pelvic pain...)

To date, no study has been conducted on the value of vagal stimulation in chronic low back pain.

lead_sponsor: University Hospital, Montpellier

location_facility:
CHU Montpellier
CHU Nîmes - Le Grau du Roi


title: Treatment of Ano-perineal Fistulas Resistant to Surgical Treatment With a Gel and Plug of Wharton's Jelly

summary: The purpose of this open, multicenter pilot trial is to evaluate the tolerance of the combination of a gel and a plug made of Wharton's jelly in the treatment of ano-perineal fistulas resistant to surgical treatment.

lead_sponsor: TBF Genie Tissulaire

location_facility: Maison de Santé Protestante de Bordeaux-Bagatelle