title: Retrospective Study on Prolonged Sedation Effects With Inhaled Agents in Pediatric Intensive Care Unit

acronym: RESPIRE

summary:
The objective of the study is to evaluate the effects of halogenated gases on sedation and analgesia, to describe the tolerance and to determine the risk factors for failure, in pediatric intensive care patients during prolonged sedation.

This study will be based on the medical records of patients hospitalized between 2015 and 2020.

lead_sponsor: Assistance Publique - Hôpitaux de Paris

location_facility:
Hôpital Armand Trousseau
Hôpital Bicêtre


title: Evaluation of the Safety and Performance of the MILTA GYNECO Vaginal Probe in Postmenopausal Women With Vaginal Atrophy Resistant to All Non-invasive Therapies for More Than 3 Months - Pilot Study of First Use in Females

acronym: SIVAM

summary:
Vulvovaginal atrophy is common after menopause, with a significant negative effect on quality of life. Large cohort studies have reported the prevalence of vaginal dryness to be between 27% and 55% and dyspareunia between 32% and 41%. Management of urogenital atrophy includes lifestyle modification, nonhormonal treatments (vaginal lubricants or moisturizers, laser treatments), as well as hormonal treatments. The disadvantages of the non-surgical methods are average results, discontinuation, and frequent contraindications to hormonal treatments.This has led to a strong interest in the development of non-invasive or minimally invasive methods that are easy to implement, effective and durable.

Photobiomodulation therapy (PBMT) has been proposed as an alternative for the treatment of genitourinary menopausal syndrome (GMS) and stress urinary incontinence. PBMT devices exert their effect via non-thermal mechanisms. PBMT stimulates collagen and elastin synthesis in the vaginal tissue, to support the urethrovaginal sphincter and urethra, and to promote vasodilation in the vaginal and urethral submucosa. PHYSIOQUANTA has developed a vaginal probe coupled with its innovative MILTA™ process synergistically combining NPCL (Nano-Pulsed Cold Laser) laser emitters, infrared diodes and RGB (Red Green Blue) diodes, operating in a magnetic tunnel. The MILTA acts deeper than LEDs, due to the diffusion of photons in soft tissues.

In this study, the study investigators aimed to evaluate the safety and performance of the MILTA™ GYNECO vaginal probe in a pilot study of first use in women. This clinical study on the MILTA vaginal probe is expected to result in its CE marking Class IIb DM.

study_start_date_type: Anticipated

status: Not yet recruiting

study_completion_date_type: Anticipated

study_type: Interventional

primary_purpose: Other

enrollment_type: Anticipated

lead_sponsor: Centre Hospitalier Universitaire de Nīmes

location_facility:
CHU Nîmes
Centre Médical KARIS

intervention_type: Device

lead_sponsor_type: academique

status_simplified: Ongoing


title: Prediction of Chronic Kidney Disease Following Pre-eclampsia: Diagnosis and Early Care

acronym: PRECEDE

summary:
Pre-eclampsia (PE) is a pregnancy-associated syndrome of variable severity, classically defined by the combination of hypertension and proteinuria in a previously non-hypertensive or proteinuric patient. These symptoms normally resolve within 2-3 months after delivery regardless of the severity of the pre-eclampsia.

Regardless of its definition, preeclampsia is associated with an increased risk of obstetric events and, for the mother, an increased risk of developing chronic kidney disease (CKD), hypertension, diabetes and cardiovascular disease in the broad sense.

The relationship between preeclampsia and Chronic Kidney Disease is, however, complex and not fully understood.

Investigator proposes an interventional study to identify the diagnosis of Chronic Kidney Disease in patients who have developed an episode of Preeclampsia.

study_start_date_type: Actual

status: Recruiting

primary_purpose: Prevention

ipd_sharing: No

lead_sponsor: Centre Hospitalier le Mans

location_facility:
Centre Hospitalier Du Mans
Chu Angers

intervention_type: Other


type: Other Identifier

title: Screening for Individual Susceptibility Factors to Immersion Pulmonary Edema

acronym: RFSI-OPI

summary: Immersion Pulmonary Edema (IPE) is a relatively new form of hemodynamic pulmonary edema. The number of cases has been increasing over the last ten years and it has become the second most common cause of hospitalization for military divers, after decompression sickness. The pathophysiological mechanisms of IPE are not completely known. Its occurrence is linked to a combination of factors related to the environmental constraints of diving, as well as to the diver's equipment. The main external factors are increased hydrostatic pressure, cold, intense effort and emotional stress. The impact of internal factors is not known. At this time, no severe forms of IPE have been identified in the military. However, it is important to identify this pathology at an early stage, even if the signs appear minor, because the continuation of underwater activity can significantly worsen the clinical picture. The risk of recurrence (greater than 15%) could result in a severe or even lethal accident.

design_allocation: Non-Randomized

primary_purpose: Screening

ipd_sharing: Undecided

lead_sponsor: Direction Centrale du Service de Santé des Armées

location_facility: Hôpital d'Instruction des Armées Sainte-Anne

location_facility: Equipe Résidente de Recherche Subaquatique Opérationnelle


title: Tolerance of the vNOTES Surgical Technique in Total Hysterectomy for Benign Lesion. Clinical Trial of Non-inferiority Compared to the Laparoscopic Technique.

acronym: VLAP

summary: During a first consultation with an indication of total hysterectomy for a benign lesion, we will study the patient's eligibility. After explanations of the study and submission of the forms, the patient will benefit from a second consultation with the investigator to give her consent. The surgeon will randomize the patient using RedCap computer software. The patient will then be referred either to the vNOTES group or to the laparoscopy group. The surgery will be performed by surgeons called "expert" in one of the ways first. For this, it will be necessary to have performed at least 25 hysterectomies by laparoscopy or vNOTES. The surgery will take place using the usual techniques. Per and postoperative complications will be studied and noted up to six months postoperatively.

design_allocation: Randomized

primary_purpose: Treatment

lead_sponsor: University Hospital, Clermont-Ferrand

location_facility:
CHU clermont-ferrand
CH d'Issoire

intervention_type: Procedure


title: IDEntification of New Predisposition Genes in Differentiated THYroid Cancer

acronym: IDENTHY-K

summary: The purpose of this research is to find new predisposition genes for differentiated thyroid cancer (DTC).

primary_purpose: Diagnostic

lead_sponsor: Nantes University Hospital

location_facility:
Nantes University Hospital
Vendée Hospital

intervention_type: Genetic


title: Wheelchair Positioning and Neuromuscular Diseases Database (Retrospective and Prospective)

acronym: BDD-POSIT-MNM

summary: This database will describe sitting postural control in wheelchair, as well as PW pain, and pressure ulcers associated with sitting, in patients with neuromuscular disease (NMD).

study_type: Observational

time_perspective: Prospective

location_facility: Groupement Hospitalier Intercommunal du Vexin / Site d'Aincourt - Pôle Soins de Suite et de Réadaptation spécialisés


title: Evaluation of Anti-cancer Drugs Sensitivity on Fresh Samples From Healthy Patients and Patients With Myeloproliferative or Lymphoproliferative Disorders

acronym: ESAAC

summary:
Hematological malignancies gather several various pathologies included myeloproliferative disorders (as acute myeloid leukemia (AML) or chronic myeloid leukemia (CML)) and lymphoproliferative disorders (as chronic lymphoid leukemia (CLL), non-Hodgkin lymphoma (NHL) and multiple myeloma (MM)) .

Over the last decade, the treatments have evolved significantly but the overall survival remains limited, especially for the AML and MM patients. There's an ongoing imperative to continue in-vitro and in-vivo studies to better evaluate the anti-cancer drugs sensitivity and therefore improving the response to treatments and open new fields of application. The healthy control group will be contributing to produce some pertinent and significant data for the results of the index cases group.

The investigators aim to analyze 10 differents drugs, common use in chemotherapy or immunotherapy and evaluate by 2 ways the sensitivity: first, Flow cytometry (cells apoptosis by Annexine V and propidium iodide) on fresh samples and in a second time, monitoring of the blasts in the mouse's blood after injection.

lead_sponsor: Hospices Civils de Lyon

location_facility: Centre Hospitalier Lyon Sud -Service de médecine du vieillissement

location_facility: Centre Hospitalier Lyon Sud -Service d'Hématologie

intervention_type: Biological


title: Observational Study Evaluating the Number of Symptomatic Cystitis-like Episodes and Urinary Comfort of Women Consuming Cranberry, Cinnamon and Probiotic Strain Extracts

summary:
Cranberries are traditionally used for urinary comfort and prevention of urinary disorders of bacterial origin and despite an EFSA opinion invalidating the clinical efficacy of cranberries, its mechanism of action has been several times proposed by the scientific community: it would act by inhibiting the synthesis of P-fimbriae leading to a complete disappearance of these adhesins, and to bacterial-type deformation by lengthening of the cell body. Cinnamon and microbiotic strains could enhance this synergy.

This study aims to evaluate the effectiveness of a food supplement based on cranberry, cinnamon and microbiotic strains (Feminabiane CBU) on the symptoms of cystitis, urinary discomfort and the number of cystitis reported by women.

lead_sponsor: CEN Biotech

intervention_type: Dietary Supplement

lead_sponsor_type: industriel


acronym: JECICA

summary:
Our hypothesis: a daily bedside echocardiographic assessment, protocolized, simple and reproducible estimation of filling pressures with an evaluation of mitral inflow and the inferior vena cava, allow a more reliable estimate of the true blood volume of the patient and thus lead to a therapeutic adjustment more suitable.

This therapeutic adjustment closer to patient's needs would impact fewer readmissions at 30 days and mortality, less alteration of biological parameters myocardial, kidney and liver.

status: Completed

study_completion_date_type: Actual

enrollment_type: Actual

location_facility:
CHU Nimes
CHU Arnaud de Villeneuve

status_simplified: Completed


title: Assessment of Depression in the Elderly : a Bias Related to the Stigmatisation of Patients Presenting in Wheelchairs

acronym: WHEELDEP

summary:
This study aims to test for a " wheelchair effect ", as a potential impact of stigma, during the evaluation of clinical global impression of depression.Elderly patients will be asked to sit in a wheelchair, or in a regular chair during recording a 5 minute video of spontaneous speech collected the iCGI semi-structured interview.

The videos are showed to 10 different psychiatrists whom each proceed to 10 iCGI rating assessments.The psychiatrists are blinded evaluators. They are not aware of the real objective of the study.

ReferenceType: background

ReferenceCitation: Krendl AC, Kensinger EA, Ambady N. How does the brain regulate negative bias to stigma? Soc Cogn Affect Neurosci. 2012 Aug;7(6):715-26. doi: 10.1093/scan/nsr046. Epub 2011 Sep 5.

ReferenceCitation: Henderson C, Noblett J, Parke H, Clement S, Caffrey A, Gale-Grant O, Schulze B, Druss B, Thornicroft G. Mental health-related stigma in health care and mental health-care settings. Lancet Psychiatry. 2014 Nov;1(6):467-82. doi: 10.1016/S2215-0366(14)00023-6. Epub 2014 Nov 5. Review.

ReferenceCitation: MacDonald ML, Butler AK. Reversal of helplessness: producing walking behavior in nursing home wheelchair residents using behavior modification procedures. J Gerontol. 1974 Jan;29(1):97-101.

ReferenceCitation: Delmas H, Batail JM, Falissard B, Robert G, Rangé M, Brousse S, Soulabaille J, Drapier D, Naudet F. A randomised cross-over study assessing the "blue pyjama syndrome" in major depressive episode. Sci Rep. 2017 Jun 1;7(1):2629. doi: 10.1038/s41598-017-02411-x.

ReferenceCitation: Kadouri A, Corruble E, Falissard B. The improved Clinical Global Impression Scale (iCGI): development and validation in depression. BMC Psychiatry. 2007 Feb 6;7:7.

ReferenceCitation: Laux G; VIVALDI Study Group. The antidepressant agomelatine in daily practice: results of the non-interventional study VIVALDI. Pharmacopsychiatry. 2012 Nov;45(7):284-91. doi: 10.1055/s-0032-1309003. Epub 2012 May 16.

ReferenceCitation: Kroenke K, Spitzer RL, Williams JB. The PHQ-9: validity of a brief depression severity measure. J Gen Intern Med. 2001 Sep;16(9):606-13.

ipd_sharing: Yes

ipd_sharing_description: Data about study protocol and clinical information will be available on request from other researchers.

lead_sponsor: Hospital Center Guillaume Régnier

location_facility:
EPSM Saint Avé
Centre Hospitalier Guillaume Regnier


title: Epidemiologic Study and Impact Study of a Dialysis Solution Change on the Electrocardiographic Profile of Patient

time_perspective: Cross-Sectional

lead_sponsor: University Hospital, Brest

location_facility:
CHU Brest
AUB


title: Protocol for Anatomopathologic Analysis of Biopsies Using Hot Clamps

acronym: PincesChaude

summary: A cross-over study of the impact of histologic results of bronchial biopsies performed using hot clamps compared to bronchial biopsies using standard clamps

lead_sponsor: Centre Hospitalier Universitaire, Amiens

location_facility:
Ch Saint Quentin
CHU Amiens


title: Integrated Management of Chronic Respiratory Diseases - eMEUSE-SANTE

acronym: eMEUSE-SANTE

summary:
Chronic respiratory diseases such as obstructive sleep apnea syndrome (OSA) and chronic obstructive pulmonary disease (COPD) constitute a major public health problem, due to their high prevalence, but especially because of their cardiovascular and metabolic morbidity and mortality and the associated costs for the health system. The organization of long-term management of these diseases is now part of the e-health process, digital health with the use of massive "big data" generated by care and follow-up. Therapeutic patient education and the integration of connected objects will allow personalized therapeutic education support with interventions by local medical staff adapted to the needs of the patients.

This will also allow to objectify the effect of treatments such as continuous positive airway pressure (CPAP) for OSA or non-invasive ventilation (NIV) and/or oxygen therapy for COPD, not only on the prevention of respiratory decompensation but also on cardiovascular and metabolic risk factors which are major elements of the prognosis. This project will therefore make it possible to demonstrate the feasibility and to deploy a multi-actor care pathway in the territory.

The investigators propose a prospective clinical study, conducted at the Verdun Hospital, with the main objective of studying the evolution of the quality of life of patients with a chronic respiratory pathology, during an integrated management at home for 6 months.

The secondary objectives:

To study the evolution of the following parameters, before treatment (at inclusion) and after 6 months of integrated management:

Treatment compliance (CPAP or NIV/oxygen therapy)
Physical activity
Weight
Mean arterial pressure
Oxygen saturation, heart rate and respiratory rate for COPD patients
Severity of COPD for the patients concerned
Daytime sleepiness
Fatigue
Patient acceptability of the use of connected objects
To analyze the trajectories of the measures collected throughout the integrated management to identify specific profiles.
To analyze the daily data of the different connected objects and treatments with regard to the patients' profiles (according to age, gender, comorbidities, OSA or COPD group).

primary_purpose: Supportive Care

lead_sponsor: University Hospital, Grenoble

location_facility:
Verdun Hospital
Grenoble Alpes University Hospital


title: Retinal Surgery With or Without Anesthesiologist, Comparison of Surgeon and Patient's Comfort

acronym: Retine-Foch

summary:
Retinal surgeries are now performed in some hospitals with sub-Tenon anesthesia to replace conventional peribulbar anesthesia. The advantages of performing the surgery with Tenonian anesthesia can be: the cost reduced due to the non-intervention of an anesthesiologist, no pre-operative anesthetic consultation, no waiting period for the effectiveness of the peribulbar anesthesia (15-20min to have the effect of anesthesia of the eye). In addition, there are more numerous and dangerous complications of peribulbar anesthesia than sub-Tenonian anesthesia, however it allows the eye to remain stationary and to perform precise surgery safely, as long as the patient does not move his head.

Performing a sub-Tenonian anesthesia also makes it possible to carry out surgeries more quickly, this method having an immediate effect and being performed by the surgeon, without the intervention of an anesthesiologist.

The edema effect under the post / conjunctiva swells the area around the eye and allows partial oculomotor limitation. Finally, for the patient, recovery is faster: no sedation or venous route.

To date, however, no study has proven that the surgeon can safely operate on the patient without increased complications compared to peribulbar anesthesia.

This study aims to show that simple sub-Tenonian anesthesia in a short outpatient circuit does not induce more pain or discomfort for the patient than a longer outpatient circuit with bed and anesthesiologist. No studies have been performed on purely local anesthesia without a venous route.

For this, patients operated on at the Foch hospital without an anesthesiologist under subtenon's anesthesia will be compared to patients operated on under peribulbar anesthesia with an anesthesiologist at the Pierre Cherest clinic.

lead_sponsor: Hopital Foch

location_facility:
Foch Hospital
Clinique Pierre Cherest


title: Benefit of Amlodipine in HRT Cycle (Hormone Replacement Therapy) for Frozen Embryo Transfer in the Correction of Uterine Pulsatility Index: Randomized Controlled Double-blind Trial.

acronym: AMLODIP

summary:
Embryo implantation depends on two main factors: embryo grading quality and endometrial receptivity.Numerous tools have been suggested to evaluate these two factors. Measurement of the pulsatility index (PI) of the uterine arteries is associated with extremely low chances of pregnancy when it is high, especially higher than 3.

A pilot study of women with premature ovarian failure with uterine PIs greater than 3 showed the efficiency of nifedipine in uterine vascularization. This calcium channel blocker, used sublingually in this study, significantly lowered uterine PI in nearly half an hour.

We are therefore interested in exploring this accessible, non-invasive and inexpensive tool, in the evaluation of endometrial receptivity before an embryo transfer.

lead_sponsor: University Hospital, Montpellier

location_facility:
CHU de Montpellier
CHU de Nîmes

intervention_type: Drug


title: Feasibility Study of the Measurement of the Placental Perfusion During the First Trimester of Pregnancy by 3D Doppler Echo-angiography With a Contrast Agent

acronym: HOPE

summary: The purpose of this study is to quantify the placental perfusion during the first trimester of pregnancy by 3D Doppler ultrasound angiography without a contrast agent and by ultrasound with a contrast agent: SonoVue®

ReferenceType: derived

ReferenceCitation: Bertholdt C, Eszto ML, Tournier M, Hossu G, Mellouki N, Cherifi A, Morel O. Assessment of uteroplacental vascularisation in early first-trimester pregnancy with contrast-enhanced ultrasound and 3D power Doppler angiography: protocol for a prospective, cross-sectional, multicentre and non-randomised open study ("HOPE Study"). BMJ Open. 2019 Sep 11;9(9):e030353. doi: 10.1136/bmjopen-2019-030353.

family: Bertholdt

full_name: Charline Bertholdt

given: Charline

sequence: first

family: Eszto

full_name: Marie-Laure Eszto

given: Marie-Laure

sequence: additional

family: Tournier

full_name: Mathilde Tournier

given: Mathilde

family: Hossu

full_name: Gabriela Hossu

given: Gabriela

family: Mellouki

full_name: Naoual Mellouki

given: Naoual

family: Cherifi

full_name: Aboubaker Cherifi

given: Aboubaker

family: Morel

full_name: Olivier Morel

given: Olivier

bso_classification: Medical research

currency_apc_doaj: GBP

datasource: user

genre: journal-article

genre_raw: journal-article

journal_name: BMJ Open

oa_colors: green gold

oa_host_type: publisher;repository

evidence: oa journal (via doaj)

host_type: publisher

license: cc-by-nc

license_normalized: cc-by-nc

version: publishedVersion

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

host_type: repository

repository_institution: PubMed Central - Europe PMC

repository_normalized: PubMed Central

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

repository_normalized: HAL

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

evidence: oa repository (via pmcid lookup)

license_normalized: no license

repositories:
HAL
PubMed Central

publisher: BMJ

publisher_dissemination: British Medical Journal

publisher_group: British Medical Journal

publisher_normalized: British Medical Journal

title: Assessment of uteroplacental vascularisation in early first-trimester pregnancy with contrast-enhanced ultrasound and 3D power Doppler angiography: protocol for a prospective, cross-sectional, multicentre and non-randomised open study (“HOPE Study”)

lead_sponsor: Centre Hospitalier Régional Metz-Thionville

location_facility:
CHRU de NANCY
Chr Metz Thionville


title: Study of Mechanisms of Emotion Regulation in Short- and Long-term Alcohol-abstinent Patients

acronym: REAL

summary:
Background:

Difficulties in assigning and identifying emotional states, or to regulate the emotional costs are recognized as one of the major factors of relapse. This study aimed to evaluate the emotion regulation processes, in short term (STA, after 1month of withdrawal) and long-term alcohol abstinent individuals (LTA, at least six months of abstinence), compared to healthy control participants (C) in a positive and negative emotion induction protocol.

Main aim:

Evaluating the emotional regulation deficits assessed with physiological indicators (heart rate variability, electrodermal response, pupil diameter) and clinically in presentations of visual stimuli to emotional value (positive, negative, neutral) in alcohol use disorder's (AUD) patients with short and long term abstinent compared to a control group of healthy subjects. The investigators are particularly interested in the evolution of heart rate variability considered as a good marker of vulnerability to AUD.

Secondary objectives:

Studying the relationships between physiological measures and clinical variables such as behavioral indicators and self-reported assessment of cognitive and emotional skills among the three groups (STA, LTA and C).

lead_sponsor: University Hospital, Lille

location_facility:
CSAPA
CHRU Lille, Fontan2


title: Identification of Genetic Basis of Atrioventricular Conduction Defects: From Congenital Forms to Degenerative Forms

summary: Identification of genes involved in congenital atrioventricular block and progressive Cardiac Conduction Disease.

location_facility:
Chu Rennes
Chu Nantes


title: Study of Familiarity in Alcohol Dependence : an Hyperfamiliarity for Faces

acronym: FALCO

summary:
Background:

Alcohol-dependence is a chronic disease with a high risk of relapse. The main therapeutic outcome relies on relapse prevention which seeks to identify high risk situations and individual's response to these situations especially the emotional response to social environment. Alcohol-dependence also induces cognitive impairments leading to social cognition impairments increasing the risk of relapse.

Familiarity is a key process in social interactions: it induces the feeling of prior knowledge of a stimulus without remembering consciously its identity. Followed by a second process based on the contribution of contextual information (recollection) familiarity allows face recognition.

Main aim:

Study of familiarity for faces in alcohol-dependence

Secondary objectives:

Highlighting correlations between familiarity impairments and clinical outcomes

status: Terminated

location_facility:
University Hospital, Lille - CSAPA
University Hospital, Lille - Fontan 2

status_simplified: Unknown


title: Prediction in Silico of Therapeutic Response in a Prospective Cohort Study of Metastatic Lung Cancer Patients

summary:
RATIONALE : Currently, the mechanisms associated with the response or resistance to treatment are poorly understood and are multifactorial. These mechanisms involve clinical and biological factors associated with the host and the tumor and possibly the patient's psycho-social environment.

PURPOSE : This trial will assess the use of a prospective database dedicated to patients with breast cancers that contains clinical data as well as epidemiological, psychological, emotional, social, imaging, biological and biopathological data. These data will allow a creation of new modelling algorithms in order to predict response and resistance to treatment.

lead_sponsor: Institut Cancerologie de l'Ouest


title: Impact of Antimicrobial Stewardship on Outcomes of Patients With Hospital-acquired Pneumonia Due to Gram-negative Bacilli - A Before-after ORACLE Study

acronym: ORACLE

summary:
Hospital-acquired pneumonia (HAP) is one of the most frequent complications and the main cause of antibiotics use in hospitalized patients, particularly in intensive care units (ICUs). The latest European and French recommendations for the management of HAP were published in 2017 and 2018. Gram-negative bacilli are frequently identified in this pneumonia.

The experts discussed the issue of tailored-empiric antimicrobial therapy. Because delayed antimicrobial therapy is associated with poor outcomes, their conclusion was to reduce the time to deliver proper antimicrobial therapy, but to limit over-use of broad-spectrum molecules. Since delays in microbiological identification hinder the ability of clinicians to streamline therapy, rapid diagnostic with multiplex PCR, which decreases the time to organism identification by 2 days compared to conventional methods, is appealing, especially for gram-negative bacilli. The FilmArray® Lower Respiratory Tract Infection Panel is a rapid multiplex PCR which tests for the most frequently pathogens (18 bacteria including plenty of gram-negative bacilli +5 genes of resistance, and 9 viruses) involved in HAP. The FilmArray® Lower Respiratory Tract Infection (LRTI) Panel has a sensitivity and a specificity of 95% and 99% respectively and can be implemented in a personalized antimicrobial guidance to treat HAP due to gram-negative bacilli. The investigators hypothesized that a rapid multiplex PCR for guidance of empiric antimicrobial therapy, especially for gram-negative bacilli, reduces the time-to-proper antimicrobial therapy and reduces the risk of death of patients suffering of HAP.

The investigators aim to assess the efficacy of an antimicrobial stewardship including the results of a rapid respiratory panel multiplex PCR for empiric antimicrobial guidance in patients with hospital-acquired pneumonia due to gram-negative bacilli.

The investigators will use a before-after design to test the efficiency of an antimicrobial stewardship including a highly innovative intervention.

location_facility:
CHU Rennes
CHU de Nantes


type: Registry Identifier

title: Impact of Alternative Blood Glucose Testing Site (Forearm) on Pain Reduction in Preterm Neonates.

acronym: NOBOBO

summary:
Numerous experimental and clinical studies have shown that preterm neonates are particularly sensitive to stress. Preterm neonates routinely undergo painful invasive procedures. Each situation causing pain or discomfort can alter their development and cause short term cardiovascular consequences but also have long-term neurocognitive influences. Repetitive procedural pain can also lead to changes in the pain sensitivity threshold therefore. The most common painful procedures are lancing for blood glucose testing. In adults, infants and term newborns, forearm blood glucose testing has been demonstrated to be less painful than conventional sites (heel, fingers). But data is lacking in preterm neonates.

The primary purpose of this study is to demonstrate a significant reduction in pain response during forearm blood lancing vs conventional sites (fingers, heel) in preterm neonates born up to 32 weeks gestation.

This study is an interventional multicenter (3 centers), randomized, double bind trial with a cross over assignment. 60 premature neonates born between 23 to 32 weeks.

Gestation with a postnatal age less than 72 hours that will undergo at least 3 blood glucose pricks will be included. The different sites will be randomly successively tested.

status: Unknown status

lead_sponsor: Assistance Publique Hopitaux De Marseille

location_facility: Assistance Publique Hôpitaux de Marseille


title: Impact of Dapagliflozin on Vascular Function in Chronic Kidney Disease Patients

acronym: DAPAVASC

summary: This study aims to determine whether dapaglfiflozin 12-week administration is associated with a beneficial impact on the vasculature of patients with chronic kidney disease.

lead_sponsor: University Hospital, Rouen

location_facility:
Department of Pharmacology
Department of Nephrology


title: Digital Action Plan for Asthma Exacerbations (PANAME)

acronym: PANAME

summary:
It is recommended that patients with asthma owned a written action plan which must include the names, doses and dosing of the treatment they should take when acute respiratory symptoms occur.

Current written action plans must be short to be readily used (1 page) and, therefore, cannot fit all acute situations. Moreover, they may not be available where and when required.

The investigators sought that a digital action plan, available through Smartphone or tablet computer connected to the internet, could adequately provide suitable action plans according to the severity of the described exacerbation, and would be more easily available when useful.

The aim of the study is to study the effect of the use of a digital action plan for asthma exacerbation, on the frequency of unscheduled medical contacts (phone calls, visits to physicians or to emergency departments, hospitalizations) in children and in adults with asthma. The investigators hypothesized that the use of the digital action plan could reduce avoidable unscheduled visits due to mild or moderate exacerbations that could successfully be managed by the patient or his/her caregivers.

lead_sponsor: Assistance Publique - Hôpitaux de Paris

location_facility: MulticEnter French study coordinate by AP-HP


title: Spectral Dynamic Imaging of Cognitive Functions in Epileptic Patients Explored

acronym: ISDETSEEG

summary: This prospective research aims to develop the use of Spectral Imaging in addition Dynamics of cortical electrical stimulation to identify major anatomical and functional networks in epileptic patients candidates for surgery and explored by stereoencephalography, to minimize risk of post-surgical cognitive deficits.

location_facility:
University Hospital Lyon
University Hospital Grenoble


title: Evaluation de l'Effet de la Stimulation Transcranienne en Courant Continu Chez Les Personnes Tabagiques dépendantes

acronym: TabaSCo

summary: The purpose of this study is to evaluate the effect of 10 sessions of anodal transcranial Direct Current Stimulation (tDCS - 1 mA) applied to left vs right CDLPF of tobacco-dependent subjects compared to the application of a placebo tDCS (sham procedure) on the craving, which is evaluated by the item 1 of Fagerström test between day 1 and day 10. Craving is also evaluated 1 month post-treatment.

lead_sponsor: Centre Hospitalier Universitaire de Besancon

location_facility: CHRU Besancon - Service de Psychiatrie - Centre Investigation Clinique Innovation Technologique (CIC-IT808)


title: Real World Effectiveness and Treatment Sequences in Patients With Extensive Stage SCLC Who Received Atezolizumab Combined With Chemotherapy as Part of the French Early Access Program (ATU).

acronym: CLINATEZO

summary: CLINATEZO cohort will evaluate overall survival, real world progression-free survival, best response and duration of treatment in patients with advanced, metastatic Small Cell Lung Cancer (SCLC) who received atezolizumab combined with chemotherapy part of the French Early Access Program (ATU). Subsequent treatments (treatment delivered immediately after treatment with atezolizumab and chemotherapy) will be recorded. Those outcomes will be correlated to clinical, pathological, and radiological characteristics of patients.

time_perspective: Retrospective

lead_sponsor: Intergroupe Francophone de Cancerologie Thoracique

location_facility:
Paris - Institut Curie
Chalon-sur-Saône - CH


title: Human PapillomaVirus (HPV) Anal Infection: Study of Prevalence and Risk Factors Among 1000 Patients Benefiting From a Colonoscopy

acronym: PAPILLAN

summary: Human papillomavirus (HPV) are involved in up to 95 % of anal canal neoplastic lesions. Little is known about HPV carriage in anal canal previous to cancer occurrence in the population and pre-neoplastic lesions, and their risk factors. PAPILLAN is a prospective study that aims to study HPV infection (HPV low grade and high grade genotypes) prevalence in anal canal in a population non selected by its HIV status. In that purpose patients are prospectively recruited in a french university hospital gastroenterology unit and anal smears are collected during a colonoscopy with cytobrush.

location_facility: Centre Hospitalier Intercommunal de la Haute Saône

location_facility: Centre Hospitalier Régional Universitaire de Besançon


title: CONDOL01: Evaluation on the Experience of Bereavement, of a Medical Consultation, Proposed by a Letter of CONDOLence to the Patients' Relatives Versus Standard Practice After the Death of the Patient: A Multicenter, Randomized Trial

summary: The aim of this randomized multicenter study is to evaluate the impact in offering the condolence letter to the family caregivers (indicated as the reliable person by the patient himself at each hospitalization) and a bereavement consultation with the reference physician.

lead_sponsor: Institut Paoli-Calmettes

location_facility:
GRAVIS
Institut Paoli Calmettes

intervention_type: Behavioral


title: Impact of Emergency Physician-Performed Ultrasound for the Evaluation of Patients With Acute Abdominal Pain, Prospective Randomized Dual Centre Study

acronym: EchoPAIN

summary:
Non-traumatic abdominal pain is one of the most frequent complaints in Emergency Medicine. Point-of-Care Ultrasound (POCUS) has good performance in these situations. It is performed at the patient's bedside with immediate results. It has been demonstrated that a clinician-performed ultrasound was able to increase the diagnosis accuracy in patients with acute abdominal pain. However, the level of evidence of its diagnostic efficacy remains controversial in particular in Europe.

The principal investigators thus aimed to investigate the efficacy of early POCUS on diagnostic accuracy in the context of of non-traumatic abdominal pain by a randomized control study conducted in two emergency departments (ED). Secondary objectives will be comparison between the two groups for time spent in the ED before diagnosis and disposition (discharged home or hospitalization), prescription of complementary examinations and in particular, radiologic exams.

lead_sponsor: Centre Hospitalier Departemental Vendee

location_facility: Centre Hospitalier Universitaire de Nantes

intervention_type: Diagnostic Test


title: Validating Digital Mobility Assessment Using Wearable Technology - the Mobilide-D Clinical Validation Study

acronym: MOBILISE-D

summary: Background and study aims The ability to move is important for general well-being. Ageing and chronic health conditions can lead to a loss of mobility and a loss of independence. In order to treat mobility loss, tools are needed that can detect and accurately measure mobility. Existing measures of mobility (based on self-reporting and one-off tests) are highly limited. Wearable digital technology (a small device worn on the body) that can be used in the home and the community can provide a simple, accurate and low-cost measure of mobility. The researchers have validated a wearable mobility monitor which can accurately measure how well a person walks by measuring aspects of mobility such as speed and symmetry. The aim of this study is to investigate the ability of the mobility monitor to measure and predict outcomes in proximal femoral fracture (PFF) patients. The digital assessment of mobility developed in this study will be used in clinical trials and in clinical practice.

location_facility: Centre Hospitalier Universitaire de Montpellier


title: Evaluation of the Effect of Peptides and n-3 Polyunsaturated Fatty Acids (n-3 PUFAs) From a Blue Fish Hydrolysate on Memory in Healthy Elderly People : a Randomised, Placebo-controlled, Double-blind Study.

acronym: BRAINBOOSTER

summary: This interventional, randomised, placebo-controlled and double-blind study aims to evaluate the effect of a dietary supplementation with a blue fish hydrolysate derived from marine by-products, containing peptides and n-3 polyunsaturated fatty acids, on cognitive performance in a healthy older population, between 60 and 73 years old, with lower memory performance.

lead_sponsor: Abyss Ingredients

location_facility: Laboratoire Nutrition et Neurobiologie Intégrée

location_facility: Plateforme de Recherche Neuro-Psychopharmacologique USR CNRS 3413 SANPSY, CHU de Bordeaux


title: Detection and Metabolic Characterization in DOPA PET/CT of no Treated Brain Metastases of Lung Cancer, Breast Cancer and Melanoma

acronym: DOPACER

summary:
About 20 to 30% of patients treated for cancer will have brain metastases. These brain metastases are found more frequently in patients with lung cancer, breast cancer or melanoma. The prognosis of these patients is unfavorable but prolonged survival can be obtained with the local and systemic treatments currently available.

Brain MRI is the gold standard for evaluating brain metastases but has limitations in therapeutic evaluation, partially offset by PET imaging of amino acid metabolism.

Our work aims to compare the performance of PET-DOPA with standard MRI for the detection of brain metastases (≥ 5mm) in lung cancer, breast cancer and melanoma; and to characterize these lesions using dynamic acquisitions obtained with a digital PET camera with high spatial resolution. Having better knowledge of the metabolic characteristics of newly discovered brain metastases, the objective of subsequent studies will be to better assess the per- or post-therapeutic efficacy of radiotherapy and the various systemic therapies available (chemotherapy, targeted therapy, immunotherapy).

location_facility:
CHU Angers
Institut de Cancerologie de l'Ouest

intervention_type: Radiation


title: Study of the Role of the Induced Membrane in the Reconstruction of Bone Loss in the Limbs

acronym: MEMBRAN

summary:
Masquelet's induced membrane technique is a two-stage reconstructive surgery for severe bone fractures commonly used by military orthopedists. The particularity of this technique relies on the synthesis of a biological membrane induced by the transient implantation of a surgical cement (= 1st stage surgery). The presence of the induced membrane in the reconstruction space defines a microenvironment or "biological chamber" favourable to osteogenesis, positively influencing the repair of the lesion after implantation of an autologous bone graft (= 2nd stage of surgery).

In view of the excellent clinical results obtained with this procedure, the Masquelet technique has gradually become a reference treatment in the field of orthopedic and trauma surgery.

However, orthopedic surgeons sometimes observe failures in bone consolidation. To our knowledge, the role played by induced membrane in these therapeutic failures has never been studied.

lead_sponsor: Direction Centrale du Service de Santé des Armées

location_facility:
Hôpital d'Instruction des Armées Percy
Hôpital d'Instruction des Armées Bégin


title: Response of Haemodialysis Patients to BNT162b2 mRNA Cov-19 Vaccine

acronym: ROMANOV

summary:
Vaccination against SARS-Cov2 is a necessity for haemodialysis patients because difficulties to maintain a self-isolation (leading to a higher contamination than general population) and an increase of mortality in case of contamination (more than 20% of mortality in this population). However, vaccine efficiency is known to be decreased in haemodialysis patients. This lead critical the rapid description of immunogenicity of anti SARS-Cov2 vaccine in haemodialysis patients.

The aim of this study is to describe the immunogenicity of the BTN162b2 SARS-Cov2 vaccine in haemodialysis patients.

lead_sponsor: Hospices Civils de Lyon

location_facility: Department of Nephrology, Hopital Edouard Herriot

location_facility: Department of Nephrology, Centre Hospitalier Lyon Sud


title: Epidemiology of Anaerobic Bacteria in Cystic Fibrosis Patients Followed by the Perharidy Cystic Fibrosis Resource and Skills Centre, Roscoff: Descriptive and Non-interventional Study

acronym: ANA-MUCO

summary:
Recently, the respiratory microbiota characterisation of a Cystic Fibrosis (CF) patients' cohort has highlighted the potential role of anaerobes, and specially species belonging to the genus Porphyromonas, in the first P. aeruginosa colonization.

The aim of this project is to describe the bacterial anaerobic population in the respiratory microbiota of a CF cohort. At the end of this study, an inventory of the anaerobic microbiota in CF respiratory samples will be establish in relation to the patients' pulmonary function and P. aeruginosa colonization status in order to speculate about the pulmonary anaerobes roles, still unknown.

The innovative aspect of the ANA-MUCO study is the use of a specific sample kit designed for the study which allows preserving anaerobic bacteria in sputum according to the recommendations of the International Human Microbiome Standards (IHMS). Extended-culture and molecular approaches will be performed to identify and describe the anaerobic bacteria which could be involved in the pulmonary homeostasis in CF respiratory samples.

ReferenceCitation: Nixon GM, Armstrong DS, Carzino R, Carlin JB, Olinsky A, Robertson CF, Grimwood K. Clinical outcome after early Pseudomonas aeruginosa infection in cystic fibrosis. J Pediatr. 2001 May;138(5):699-704.

ReferenceCitation: Cox MJ, Allgaier M, Taylor B, Baek MS, Huang YJ, Daly RA, Karaoz U, Andersen GL, Brown R, Fujimura KE, Wu B, Tran D, Koff J, Kleinhenz ME, Nielson D, Brodie EL, Lynch SV. Airway microbiota and pathogen abundance in age-stratified cystic fibrosis patients. PLoS One. 2010 Jun 23;5(6):e11044. doi: 10.1371/journal.pone.0011044.

ReferenceCitation: Renwick J, McNally P, John B, DeSantis T, Linnane B, Murphy P; SHIELD CF. The microbial community of the cystic fibrosis airway is disrupted in early life. PLoS One. 2014 Dec 19;9(12):e109798. doi: 10.1371/journal.pone.0109798. eCollection 2014.

ReferenceCitation: Klepac-Ceraj V, Lemon KP, Martin TR, Allgaier M, Kembel SW, Knapp AA, Lory S, Brodie EL, Lynch SV, Bohannan BJ, Green JL, Maurer BA, Kolter R. Relationship between cystic fibrosis respiratory tract bacterial communities and age, genotype, antibiotics and Pseudomonas aeruginosa. Environ Microbiol. 2010 May;12(5):1293-303. doi: 10.1111/j.1462-2920.2010.02173.x. Epub 2010 Feb 23.

ReferenceCitation: Sibley CD, Surette MG. The polymicrobial nature of airway infections in cystic fibrosis: Cangene Gold Medal Lecture. Can J Microbiol. 2011 Feb;57(2):69-77. doi: 10.1139/w10-105. Review.

ReferenceCitation: Bernarde C, Keravec M, Mounier J, Gouriou S, Rault G, Férec C, Barbier G, Héry-Arnaud G. Impact of the CFTR-potentiator ivacaftor on airway microbiota in cystic fibrosis patients carrying a G551D mutation. PLoS One. 2015 Apr 8;10(4):e0124124. doi: 10.1371/journal.pone.0124124. eCollection 2015.

ReferenceCitation: Guilloux CA, Lamoureux C, Héry-Arnaud G. [Anaerobic bacteria, the unknown members of the lung microbiota]. Med Sci (Paris). 2018 Mar;34(3):253-260. doi: 10.1051/medsci/20183403014. Epub 2018 Mar 16. Review. French.

ReferenceCitation: Tunney MM, Field TR, Moriarty TF, Patrick S, Doering G, Muhlebach MS, Wolfgang MC, Boucher R, Gilpin DF, McDowell A, Elborn JS. Detection of anaerobic bacteria in high numbers in sputum from patients with cystic fibrosis. Am J Respir Crit Care Med. 2008 May 1;177(9):995-1001. doi: 10.1164/rccm.200708-1151OC. Epub 2008 Feb 8.

ReferenceCitation: Smyth AR, Bell SC, Bojcin S, Bryon M, Duff A, Flume P, Kashirskaya N, Munck A, Ratjen F, Schwarzenberg SJ, Sermet-Gaudelus I, Southern KW, Taccetti G, Ullrich G, Wolfe S; European Cystic Fibrosis Society. European Cystic Fibrosis Society Standards of Care: Best Practice guidelines. J Cyst Fibros. 2014 May;13 Suppl 1:S23-42. doi: 10.1016/j.jcf.2014.03.010. Review.

ReferenceCitation: Héry-Arnaud G, Nowak E, Caillon J, David V, Dirou A, Revert K, Munck MR, Frachon I, Haloun A, Horeau-Langlard D, Le Bihan J, Danner-Boucher I, Ramel S, Pelletier MP, Rosec S, Gouriou S, Poulhazan E, Payan C, Férec C, Rault G, Le Gal G, Le Berre R. Evaluation of quantitative PCR for early diagnosis of Pseudomonas aeruginosa infection in cystic fibrosis: a prospective cohort study. Clin Microbiol Infect. 2017 Mar;23(3):203-207. doi: 10.1016/j.cmi.2016.11.016. Epub 2016 Nov 27.

ReferenceCitation: Lamoureux C, Guilloux CA, Beauruelle C, Jolivet-Gougeon A, Héry-Arnaud G. Anaerobes in cystic fibrosis patients' airways. Crit Rev Microbiol. 2019 Feb;45(1):103-117. doi: 10.1080/1040841X.2018.1549019. Epub 2019 Jan 21. Review.

ReferenceCitation: Société Française de Microbiologie. REMIC, Référentiel en Microbiologie Médicale, 2 volumes. SFM, 2015. 856 p. ISBN 9782878050325.

ReferenceCitation: CA-SFM EUCAST [En ligne]. Société Française de Microbiologie, 2013 [consulté le 11 janvier 2018]. Available on: http://www.sfmmicrobiologie.org/UserFiles/files/casfm/CASFM2013vjuin.pdf

ReferenceCitation: Héry-Arnaud et al., 2017, European patent EP17306297 Methods for predicting the risk of developping pulmonary colonization/infection by Pseudomonas aeruginosa.

ReferenceCitation: Keravec M, Mounier J, Guilloux CA, Fangous MS, Mondot S, Vallet S, Gouriou S, Le Berre R, Rault G, Férec C, Barbier G, Lepage P, Héry-Arnaud G. Porphyromonas, a potential predictive biomarker of Pseudomonas aeruginosa pulmonary infection in cystic fibrosis. BMJ Open Respir Res. 2019 Mar 12;6(1):e000374. doi: 10.1136/bmjresp-2018-000374. eCollection 2019.

ipd_sharing_description: All collected data that underlie results in a publication.

lead_sponsor: University Hospital, Brest

location_facility:
Fondation Ildys
CHRU de Brest


acronym: VESTIBULE

summary: The main objective of this study is to compare the efficacy of botulinum toxin injections on vestibulodynia pain compared to a group treated with a placebo.

location_facility:
CHU Besançon
Hôpital Tenon


title: Etude de l'INflammation systémique de Bas GRade Chez Les Patients Adultes Atteints de PHénylcétonurie

acronym: INGRAPH

summary:
Patient suffering from phenylketonuria have chronic hyperphenylalaninemia. Hyperphenylalaninemia is known to be toxic to central nervous system and cardiovascular system in particular through oxydative stress.

In this context, research of low grade systemic inflammation through cytokine assay appears legitimate.

The primary outcome of this study is to describe inflammation profile of patients with phenylketonuria.

ReferenceCitation: Solverson P, Murali SG, Brinkman AS, Nelson DW, Clayton MK, Yen CL, Ney DM. Glycomacropeptide, a low-phenylalanine protein isolated from cheese whey, supports growth and attenuates metabolic stress in the murine model of phenylketonuria. Am J Physiol Endocrinol Metab. 2012 Apr 1;302(7):E885-95. doi: 10.1152/ajpendo.00647.2011. Epub 2012 Jan 31.

ReferenceCitation: van Spronsen FJ, van Wegberg AM, Ahring K, Bélanger-Quintana A, Blau N, Bosch AM, Burlina A, Campistol J, Feillet F, Giżewska M, Huijbregts SC, Kearney S, Leuzzi V, Maillot F, Muntau AC, Trefz FK, van Rijn M, Walter JH, MacDonald A. Key European guidelines for the diagnosis and management of patients with phenylketonuria. Lancet Diabetes Endocrinol. 2017 Sep;5(9):743-756. doi: 10.1016/S2213-8587(16)30320-5. Epub 2017 Jan 10. Review.

ReferenceCitation: Boulet L, Besson G, Van Noolen L, Faure P; ECOPHEN Study Group, Maillot F, Corne C. Tryptophan metabolism in phenylketonuria: A French adult cohort study. J Inherit Metab Dis. 2020 Sep;43(5):944-951. doi: 10.1002/jimd.12250. Epub 2020 Jun 4.

ReferenceCitation: Stroup BM, Nair N, Murali SG, Broniowska K, Rohr F, Levy HL, Ney DM. Metabolomic Markers of Essential Fatty Acids, Carnitine, and Cholesterol Metabolism in Adults and Adolescents with Phenylketonuria. J Nutr. 2018 Feb 1;148(2):194-201. doi: 10.1093/jn/nxx039.

ReferenceCitation: Matalon R, Surendran S, McDonald JD, Okorodudu AO, Tyring SK, Michals-Matalon K, Harris P. Abnormal expression of genes associated with development and inflammation in the heart of mouse maternal phenylketonuria offspring. Int J Immunopathol Pharmacol. 2005 Jul-Sep;18(3):557-65.

lead_sponsor: University Hospital, Tours

location_facility: Clinical investigation center, University Hospital, Tours

location_facility: Internal Medicine Service, University Hospital, Tours


title: Comparison of the Incidence of 3 Inspiratory Muscle Training Programs on Inspiratory Strength, on Difficult to Wean Patients in Intensive Care Unit: a Multi-centre Randomised Trial.

acronym: PREDRIC

summary:
Ventilator-induced diaphragmatic dysfunction appears to contribute to slow weaning from mechanical ventilation. Several trials of inspiratory muscle training to facilitate weaning in intensive care have been performed, with inconsistent results, utilizing different methods of IMT in different populations.

In this study, the investigators want to compare the incidence of 3 inspiratory muscle training programs on inspiratory strength, on difficult to wean patients in intensive care unit.

This is a multi-center randomized trial not blinded with 3 parallels groups:

Martin's group: a threshold-based IMT is performed like used by Martin in a randomized trial in 2011, in a view of inspiratory strength increase.
Cader's group: a threshold-based IMT is performed like used by Cader in a randomized trial in 2010 , in a view of inspiratory endurance increase.
EDRIC's group: a new treshold-based IMT is performed, in a view of both inspiratory strength and endurance increase.

The investigators think that a new threshold-based IMT performed in a view of both inspiratory strength and endurance increase, is more effective and well tolerated than the 2 others protocols.

lead_sponsor: University Hospital, Bordeaux


title: PyROphosPHate Supplementation to Fight ECtopIc Calcification in PseudoXanthoma Elasticum: PROPHECI Study

acronym: PROPHECI

summary:
Pseudoxanthoma elasticum (PXE) is a rare inherited metabolic disorder (OMIM 264800, frequency 1/25000) characterized by progressive ectopic calcification of connective tissues.

PXE mainly affects the skin (unsighting skin folds and papules), the retina (central blindness), the vasculature (peripheral arterial occlusive disease and stroke) and the renal system (renal lithiasis) in adulthood. Although rarely, early lethal forms have been reported.

This chronic and highly disabling condition results from a loss of function of the gene encoding for the ABCC6 membrane transporter primarily expressed in the hepatocytes and renal tubular cells. Recently, it has been reported that PXE was characterized by a 50-60% decrease in the plasma level of inorganic pyrophosphate (PPi), a major physiological anti-calcifying factor. PXE is an incurable disease although encouraging advances with animals PXE models and human patients were obtained with the use of etidronate (Eti), a stable, non-hydrolysable analog of PPi.

However, this proof-of-concept study was statistically underpowered, mitigating the overall results, notably with respect to the effect on vascular calcification and ocular lesions. Renal lithiasis was also not investigated in the study.

Furthermore, the long term use of Eti maybe a concern because of its side-effects (spontaneous fracture and mandibular necrosis) and the fact that non-hydrolysable bisphosphonate lead to stable and irreversible calcification.

Recent studies in animals and healthy volunteers have shown that, contrary to what was initially reported and thought, the oral administration of PPi salts resulted in increased PPi plasma levels, opening up new therapeutic perspectives in PXE by using PPi in place of Eti.

Therefore,the investigators propose to perform the first Phase II randomized controlled trial (RCT) to evaluate the safety and efficacy of a daily and oral administration of PPi salts against safety and efficacy of treatment with Eti (reference treatment) in PXE patients.

lead_sponsor: Centre Hospitalier Universitaire de Nice

location_facility:
Angers Hospital
Nice Hospital


title: Clinical Study of Repetitive Transcranial Magnetic Stimulation (RTMS) Efficacy Coupled With Mirror Therapy for Neuropathic Pain Relief

acronym: STIRM

summary: Neuropathic pain is particularly difficult to treat with classic first-line drugs. Neuromodulation techniques using repetitive transcranial magnetic stimulation (rTMS) are useful alternative, but there is a need to improve their analgesic effect.Virtual reality mirror therapy has shown the capacity to alleviate pain and may be easily coupled with rTMS.The present project will investigate in individuals with neuropathic pain the effects of the rTMS coupled with virtual reality mirror therapy.

lead_sponsor: Centre Hospitalier Universitaire de Saint Etienne

location_facility: Centre Hospitalier Universitaire de Saint-Etienne


title: Multicenter Prospective Study Evaluating the Interest of HE4 in the Diagnostic Approach of Endometrial Cancer in Patients With Postmenopausal Bleeding

acronym: METRODEC

summary: This study aims to explore the sensitivity of an innovative marker, HE4, in the diagnosis approach of endometrial cancer in case of postmenopausal bleedings.

lead_sponsor: Nantes University Hospital

location_facility:
Vendee Hospital Center
Saint-Nazaire Hospital


title: PREMODEUR. "Odors to Insufflate Life". Implementation of a Controlled Olfactory Sensorial Method to Decrease Apneas in Premature Newborns. Proof of Concept Study. Latin-square Open Study With Blind Evaluation of Primary Outcome.

acronym: PREMODEUR

summary: Apneas concern about 85% of premature newborns (NB) born after less than 34 weeks of pregnancy. They are considered as an important risk factor for subsequent neuropsychological deficiency. Current pharmacological treatments are not very effective, and have side effects (agitation, irritability, sleep disorders, tachycardia). Some studies suggest that in NBs with apneas resisting to drugs, a permanent odorisation with a drop of vanillin on the incubator's pillow might reduce the frequency of apneas. This latin square design study will test a controlled olfactory stimulation method, i.e. an olfactometer which controls the odor duration, intensity, and sequence using three different odors, to reduce apneic episodes measured using 24-registration of heart and respiratory rates.

ReferenceCitation: Duchamp-Viret P, Nguyen HK, Maucort-Boulch D, Remontet L, Guyon A, Franco P, Cividjian A, Thevenet M, Iwaz J, Galletti S, Kassai B, Cornaton E, Plaisant F, Claris O, Gauthier-Moulinier H. Protocol of controlled odorant stimulation for reducing apnoeic episodes in premature newborns: a randomised open-label Latin-square study with independent evaluation of the main endpoint (PREMODEUR). BMJ Open. 2021 Sep 13;11(9):e047141. doi: 10.1136/bmjopen-2020-047141.

location_facility:
Hopital Femme Mère Enfant
CHU de Saint-Etienne


title: Proteomic Characterization of Aggressive Oligodendrogliomas

acronym: PROGLIO

summary:
Oligodendrogliomas represent a distinct subgroup of adult gliomas characterized by specific molecular alterations (1p/19q codeletion, mutations of IDH, TERT promoter, CIC, FUBP1). These tumors account for 5 to 10% of adult gliomas and are of special relevance in the neuro-oncology field because of their frequent chemosensitivity (Louis et al. 2016). The genetics of oligodendrogliomas is relatively well characterized but the mechanisms of oncogenesis for these tumors are poorly understood.

Although oligodendrogliomas prognosis is usually better than that of other adult glioma subtypes, it remains heterogeneous and there is no effective treatment at recurrence after radiotherapy and chemotherapy. Our recent work conducted within the INCa-funded national POLA network has related this clinical heterogeneity to inter-tumoral heterogeneity. Based on a transcriptomic analysis of a large series of oligodendroglial gliomas we identified 3 subgroups, the most aggressive group being characterized by aggressive clinical and molecular pattern. Recent studies, however, have shown a relatively low level of concordance between mRNA and protein expression, emphasizing the need to use proteomic-based approaches to better understand tumor biology. Taking advantage of the POLA cohort, we propose to expand our previous analysis by integrating a proteomic analysis of oligodendrogliomas.

The aim of this project is to identify drivers of oligodendroglioma subgroups, among which potential druggable targets (i.e receptors, metabolism effectors). For this purpose, the proteomic profiles of 90 oligodendrogliomas will be generated and integrated with transcriptomic, genomic and methylation profiles in order to identify signaling pathways specifically associated with each subtype, especially with the most aggressive one. Associations will be explored between candidate signaling pathways expression and clinical outcomes (survival, progression-free survival, objective response). The relevance of the 2 most promising candidate signaling pathways will be assessed in vitro and in vivo using genetically relevant mouse and xenograft models.

Our project will identify targetable oncogenic pathways associated with poor prognosis that could lead to new therapeutic strategies.

location_facility:
Groupement Hospitalier Est HCL
Institut du Cerveau et de la Moelle


title: Memory for Action in Neurological Patients

acronym: EMBODIMENT

summary:
Memory for action is especially important in everyday life although current literature is not very abundant. The enactment effect (i.e. better memory for performed actions than for verbally encoded sentences) is usually described as a robust effect in aging and can be found in many diseases. Although the enactment effect has been studied for three decades, there is still no consensus on how it enhances memory. Therefore, in order to gain additional insight into the representational basis of the enactment effect, in the present study, the investigators propose to test neurological patients. The investigators suggested that memory for action should be better than memory for verbally encoded information in Alzheimer's disease and Parkinson's disease.

If patients with Alzheimer's disease (AD) and Parkinson's disease (PD) have no cognitive assessment during the last 6 months, then they will realize different tests: MMSE (1), HAD (2), a cognitive assessment (3); (4); BREF (5); Assessment of apraxia, (6). Controls will perform the same tests to verify that they have no cognitive impairment. Then, two experimental conditions will be presented in all patients and controls: a first in which participants will have to name drawings (verbal learning) and a second in which they will have to reproduce an action associated with drawings (action learning). Immediately after this learning phase, a recognition task will be available and therefore participants will have to recognize drawings that had been presented previously. The main criteria used in the statistical analysis will be the correct recognition score.

primary_purpose: Basic Science

location_facility:
Hcl - Cm2R
CHU de Saint-Etienne


title: Impact of Side to Side Gastrojejunostomy on the Rate of Delayed Gastric Emptying After Pancreaticoduodenectomy: A Prospective Randomized Study

acronym: IPAD

summary: Prospective bi-centric randomized open-label study comparing side to side and end to side gastrojejunostomy in pancreaticoduodenectomy

lead_sponsor: Rennes University Hospital

location_facility:
CHU de Rennes
Institut Paoli Calmettes


title: Appropriation of the Connected Solution Freestyle Libre® in Adult Patients With Diabetes in the Context of Therapeutic Education

acronym: APPRO-FSL

summary: Following the proposal to self-monitor by the Freestyle Libre® (FSL) connected object, in diabetic patients in the context of therapeutic education, regarding the appropriation of FSL, what works, for which patients , in what specific contexts and by what mechanisms does it govern? A multicentric observational research will be conducted with mixed method design (follow-up using patient questionnaires) and semi-structured interviews of patients and caregivers.

location_facility:
Hopital d'Instruction des Armées Bégin
Hôpital Avicenne


title: Study of Genetic and Cellular Immunological Parameters Predictive of Disease-free Survival in Patients With Metastatic Cancer

summary: The aim of this study is to characterize the genetic and cellular immunological parameters of metastatic digestive cancer patients having short and long responses to chemotherapy.

location_facility: Centre Hospitalier Universitaire de Besançon


title: Exploration of Differences in Metabolite Concentrations by 7Teslas NMR Spectroscopy in Striatum and Subthalamic Nuclei in de Novo Parkinsonian Patients and Control Subjects

summary:
Initially, the exploration of brain metabolism by Nuclear Magnetic Resonance Spectroscopy (MRS) of the high magnetic field proton (1H) (11.7T) applied to acute and chronic animal models of Parkinson's disease (PD) showed glutamatergic hyperactivity within the striatum, one of the components of the basal ganglia. Interestingly, acute administration of L-dopa and acute, subchronic and chronic deep brain stimulation of the subthalamic nucleus (STN) normalizes these neurochemical profiles. Investigators also show an increase in glutamate levels in the STN ipsilateral to the substantia nigra pars compacta (SNpc) damaged by the neurotoxin, expected phenomenon, but also and surprisingly in the STN controlateral to the lesion. A degeneration of dopaminergic neurons is also observed in the controlateral SNpc at the lesion suggesting that the hyperglutamatergy of the controlateral STN to the lesion could promote neuronal death in the SNpc and thus participate in the progression and lateralization of the PD.

Using 3T MRS in PD patients, as in other studies in humans, investigators do not see changes in glutamate and glutamine levels in the putamen of Parkinsonian patients. This difference between animal and human studies can be explained:

by the different rate of progression between PD in humans and animal models with plasticity phenomena limiting glutamatergic hyperactivity,
by the effect of treatment in PD masking changes in glutamate metabolism,
by limiting sensitivity in the detection of metabolites (Glutamate, glutamine, GABA) at 3T.

The 7T 1H MRS improves the dispersion of chemical shifts of the metabolites studied, increases the sensitivity of the measurement, makes it possible to select regions of interest of smaller volumes (1 cm3) and thus limits the magnetic susceptibility effects that degrade the quality of the measured signal. This makes it possible to reliably separate glutamate and glutamine peaks.

In this context, investigators propose to study the metabolic changes in a homogeneous group of de novo Parkinsonian patients, naive to any treatment intended to replace the missing dopamine. The gain in spatial resolution, contrast and signal will allow better characterization of localized anomalies in small-volume structures such as basal ganglia, putamen and STN.

lead_sponsor: University Hospital, Clermont-Ferrand

location_facility:
CHU Poitiers
Chu Clermont Ferrand


title: Early Integration of Supportive Care Into Standard Oncology Care for Metastatic Uveal Melanoma Patients

summary:
The study main objective is to assess whether the early introduction of supportive care demonstrates a benefit on patients' psychological care needs at 6 months (M6), versus oncological standard of care in patients with metastatic UM.

Supportive care in patients with metastatic Uveal Melanoma (UM)

lead_sponsor: Institut Curie

location_facility:
Centre Antoine Lacassagne
Institut Curie


title: A Randomized Prospective Multicenter Study Comparing Fibula Free-flap Mandibular Reconstruction With or Without Preoperative Virtual Planning in Patients With Oral or Oropharyngeal Cancer

acronym: CURVE

summary: This is a national multicenter, randomized, stratified, open label study, aiming to compare mandibular reconstruction (MR) with or without preoperative virtual planning (PVP), in patients with oral/oropharyngeal cancer (OOPC).

lead_sponsor: UNICANCER

location_facility:
Centre Antoine Lacassagne
CHU Groupe Hospitalier Pellegrin


type: Other Grant/Funding Number

title: Interventional Study With Low Risks and Constraints on the Effect of KCNQ1 Mutation (Romano-Ward Syndrome) on Insulin Tolerance and Obsessive Compulsive Features, a Cross-sectional Study With Matched Controls With an Attempt of Linkage to Whole Genome Scanning.

acronym: PRIME

summary: The objectives of the study are to investigate if KCNQ1 mutation in Romano-Ward long QT patients can be associated with changes in insulin regulation and with psychological features of compulsivity, impulsivity and behavioural rigidity.

ReferenceCitation: Torekov SS, Iepsen E, Christiansen M, Linneberg A, Pedersen O, Holst JJ, Kanters JK, Hansen T. KCNQ1 long QT syndrome patients have hyperinsulinemia and symptomatic hypoglycemia. Diabetes. 2014 Apr;63(4):1315-25. doi: 10.2337/db13-1454. Epub 2013 Dec 18.

ReferenceCitation: van de Vondervoort I, Poelmans G, Aschrafi A, Pauls DL, Buitelaar JK, Glennon JC, Franke B. An integrated molecular landscape implicates the regulation of dendritic spine formation through insulin-related signalling in obsessive-compulsive disorder. J Psychiatry Neurosci. 2016 Jun;41(4):280-5. Review.

ReferenceCitation: van de Vondervoort IIGM, Amiri H, Bruchhage MMK, Oomen CA, Rustogi N, Cooper JD, van Asten JJA, Heerschap A, Bahn S, Williams SCR, Buitelaar JK, Poelmans G, Glennon JC. Converging evidence points towards a role of insulin signaling in regulating compulsive behavior. Transl Psychiatry. 2019 Sep 12;9(1):225. doi: 10.1038/s41398-019-0559-6.

ReferenceCitation: Southgate L, Tchanturia K, Collier D, Treasure J. The development of the childhood retrospective perfectionism questionnaire (CHIRP) in an eating disorder sample. Eur Eat Disord Rev. 2008 Nov;16(6):451-62. doi: 10.1002/erv.870.

ReferenceCitation: Foa EB, Huppert JD, Leiberg S, Langner R, Kichic R, Hajcak G, Salkovskis PM. The Obsessive-Compulsive Inventory: development and validation of a short version. Psychol Assess. 2002 Dec;14(4):485-96.

ReferenceCitation: Lynam, D.R., Smith, G.T., Whiteside, S.P., Cyders, M.A. (2006). The UPPS-P: Assessing five personality pathways to impulsive behavior (Technical Report). West Lafayette: Purdue University.

ReferenceCitation: Zermatten, A., Van der Linden, M., Jermann, F., Ceschi, G. Validation of a French version of the Obsessive-Compulsive Inventory-Revised in a non-clinical sample. (2006). Revue Européenne de Psychologie Appliquée. 56:151-155

ReferenceCitation: Van der Linden, M., d'Acremont, M., Zermatten, A., Jermann, F., Laroi, F., Willems, S., Juillerat, A., Bechara, A. (2006). A French Adaptation of the UPPS Impulsive Behavior Scale: Confirmatory factor analysis in a sample of undergraduate students. Eur J Psychol Assess. 22:38-42.

ReferenceType: result

ReferenceCitation: Fatima SS, Chaudhry B, Khan TA, Farooq S. KCNQ1 rs2237895 polymorphism is associated with Gestational Diabetes in Pakistani Women. Pak J Med Sci. 2016 Nov-Dec;32(6):1380-1385. doi: 10.12669/pjms.326.11052.

apc_source: doaj

family: Fatima

full_name: Syeda Sadia Fatima

given: Syeda Sadia

family: Chaudhry

full_name: Bushra Chaudhry

given: Bushra

family: Khan

full_name: Taseer Ahmed Khan

given: Taseer Ahmed

family: Farooq

full_name: Saad Farooq

given: Saad

currency_apc_doaj: USD

journal_name: Pakistan Journal of Medical Sciences

license: cc-by

license_normalized: cc-by

evidence: oa repository (via OAI-PMH title and first author match)

publisher: Pakistan Journal of Medical Sciences

publisher_dissemination: Pakistan Journal of Medical Sciences

publisher_group: Pakistan Journal of Medical Sciences

publisher_normalized: Pakistan Journal of Medical Sciences

ipd_sharing_description: All anonymized individual participant data will be shared within the PRIME consortium collaborators in accordance with the PRIME Consortium Agreement

lead_sponsor: Biotrial

location_facility:
L'Institut du Thorax, Nantes Hospital
Biotrial Clinical Unit


title: Use of a Connected Companion in Children With Cystic Fibrosis - COMPANION-CF

acronym: COMPANION-CF

summary:
The study will be conducted over a 6 months period. For the first three months, the child will be accompagned with a connected companion. After this period, the companion will be removed for three months in oder to prove this companion could improve treatment adherence for children suffering from cytolisis fibrosis.

This study will be conducted at the University Hospital Center of Rennes and Hospital Center of Saint-Brieuc.

ReferenceCitation: De Geest S, Sabaté E. Adherence to long-term therapies: evidence for action. Eur J Cardiovasc Nurs. 2003 Dec;2(4):323.

ReferenceCitation: Jentzsch NS, Camargos PA, Colosimo EA, Bousquet J. Monitoring adherence to beclomethasone in asthmatic children and adolescents through four different methods. Allergy. 2009 Oct;64(10):1458-62. doi: 10.1111/j.1398-9995.2009.02037.x. Epub 2009 Mar 28.

family: Jentzsch

full_name: N. S. Jentzsch

given: N. S.

family: Camargos

full_name: P. A. M. Camargos

given: P. A. M.

family: Colosimo

full_name: E. A. Colosimo

given: E. A.

family: Bousquet

full_name: J. Bousquet

given: J.

journal_name: Allergy

publisher: Wiley

publisher_dissemination: Wiley

publisher_group: Wiley

publisher_normalized: Wiley

ReferenceCitation: Zindani GN, Streetman DD, Streetman DS, Nasr SZ. Adherence to treatment in children and adolescent patients with cystic fibrosis. J Adolesc Health. 2006 Jan;38(1):13-7.

ReferenceCitation: Conway SP, Pond MN, Hamnett T, Watson A. Compliance with treatment in adult patients with cystic fibrosis. Thorax. 1996 Jan;51(1):29-33.

ReferenceCitation: Arias Llorente RP, Bousoño García C, Díaz Martín JJ. Treatment compliance in children and adults with cystic fibrosis. J Cyst Fibros. 2008 Sep;7(5):359-67. doi: 10.1016/j.jcf.2008.01.003. Epub 2008 Mar 4.

family: Arias Llorente

full_name: Rosa Patricia Arias Llorente

given: Rosa Patricia

family: Bousoño García

full_name: Carlos Bousoño García

given: Carlos

family: Díaz Martín

full_name: Juan José Díaz Martín

given: Juan José

journal_name: Journal of Cystic Fibrosis

oa_host_type: publisher

evidence: open (via crossref license)

license: elsevier-specific: oa user license

license_normalized: elsevier-specific

publisher: Elsevier BV

publisher_dissemination: Elsevier

publisher_group: Elsevier

publisher_normalized: Elsevier

title: Treatment compliance in children and adults with Cystic Fibrosis

ReferenceCitation: Sanchis J, Gich I, Pedersen S; Aerosol Drug Management Improvement Team (ADMIT). Systematic Review of Errors in Inhaler Use: Has Patient Technique Improved Over Time? Chest. 2016 Aug;150(2):394-406. doi: 10.1016/j.chest.2016.03.041. Epub 2016 Apr 7. Review.

family: Sanchis

full_name: Joaquin Sanchis

given: Joaquin

family: Gich

full_name: Ignasi Gich

given: Ignasi

family: Pedersen

full_name: Soren Pedersen

given: Soren

journal_name: Chest

oa_colors: green hybrid

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

repository_institution: University of Southern Denmark - University of Southern Denmark Research Portal

ReferenceCitation: O'Donohoe R, Fullen BM. Adherence of subjects with cystic fibrosis to their home program: a systematic review. Respir Care. 2014 Nov;59(11):1731-46. doi: 10.4187/respcare.02990. Epub 2014 Jul 15. Review.

title: Adherence of Subjects With Cystic Fibrosis to Their Home Program: A Systematic Review

ReferenceCitation: Britto MT, Rohan JM, Dodds CM, Byczkowski TL. A Randomized Trial of User-Controlled Text Messaging to Improve Asthma Outcomes: A Pilot Study. Clin Pediatr (Phila). 2017 Dec;56(14):1336-1344. doi: 10.1177/0009922816684857. Epub 2017 Jan 5.

name: Cincinnati Children’s Hospital Medical Center, Cincinnati, OH, USA

name: Boston Children’s Hospital, Boston, MA, USA

location_facility:
Chu Rennes
Centre Hospitalier de Saint-Brieuc


title: Evaluation and Characterization of Behavioural Disorders and Dementias by the Behavioural Dysexecutive Syndrome Inventory (BDSI)

acronym: ISDC

summary: Behavioural disorders are very common right from the initial stage of dementia and contribute to loss of autonomy. Behavioural dysexecutive disorders have a particular status due to their prevalence and their diagnostic importance, as they often constitute the initial symptoms of Frontotemporal Dementia (FTD), Semantic Dementia (SD) and Huntington's disease (HD) and they are classically more frequent in vascular dementia (VaD) than in Alzheimer's disease (AD). The presence of these disorders at the stage of Mild Cognitive Impairment (MCI) has only been partially evaluated and would increase the risk of progression to dementia. These classical data are based on non-standardized assessments and non-validated diagnostic criteria. The Groupe de Reflexion pour l'Evaluation des Fonctions EXécutives (GREFEX) has developed a standardized assessment tool for behavioural dysexecutive disorders, the Behavioural Dysexecutive Syndrome Inventory (BDSI) and has validated diagnostic criteria for this syndrome.

lead_sponsor: Centre Hospitalier Universitaire, Amiens

location_facility:
CHU Strasbourg
CHU Amiens


title: Experiences, Expectations and Needs of Children Whose Parents Have Cystic Fibrosis - Exploratory Study

acronym: MUCOKIDS

summary:
As more and more patients with cystic fibrosis (CF) become parents, we have studied parenting concerns in this serious chronic disease in a first study (MucoPar) which is ongoing.

The current study (MucoKids) is an extension of the previous MucoPar study and aims to explore and collect the perceptions, expectations and needs of children whose one parent has CF.

This will be done in the context of individual interviews or in several small groups of children led by a psychologist who will encourage them to develop what constitutes to be the child of somebody with CF.

The collected information should make it possible to develop and propose adapted medico-psycho-social interventions, if necessary, in connection with patient associations.

lead_sponsor: Assistance Publique - Hôpitaux de Paris

location_facility:
Cochin Hospital
Foch Hospital


title: Modification of Digestive Flora After Gastric Bypass : Pilot Study on Microbial Overgrowth Using Gas Chromatography

acronym: SIBOB

summary: The objective of this research is to determine the incidence of microbial overgrowth of the small intestine before and after a gastric bypass. For this purpose, the study is based on the analysis of the expired hydrogen H2 with gas chromatography before surgery and at 1, 3, 6, 12, 18 and 24 months.

lead_sponsor: Lille Catholic University

location_facility:
Centre Hospitalier d'Arras
Centre Hospitalier de Douai


title: Chronic Intradialytic Exercise: a Cardioprotective Role

acronym: EX-CHRODIAL

summary: The main objective is to assess the effects of chronic intradialytic physical exercise on myocardial remodelling and regional function.

lead_sponsor: University of Avignon

location_facility:
ATIR
Centre Hemodialyse AIDER sante


title: Effect of Tenofovir/Emtricitabine Short Course on Viral Clearance in Patients Recently Infected With SARS-COV2 (Covid-19) Not Requiring Hospitalization: a Phase IIB/III Multicenter Open-label Randomized Controlled Trial

summary: COVID-19 pandemic is currently affecting the globe. To date, there is no effective oral therapy against SARS-CoV2 infection. The investigators propose to test as a repurposing drug combination, a short course of tenofovir disoproxil and emtricitabine (TDF/FTC), as a proof-of-concept randomized open-label study to test its viral efficacy against SARS-CoV2.

ReferenceCitation: Parienti JJ et al. EClinicalMedicine 2021: https://authors.elsevier.com/sd/article/S2589-5370(21)00273-X

ReferenceCitation: Parienti JJ, Prazuck T, Peyro-Saint-Paul L, Fournier A, Valentin C, Brucato S, Verdon R, Sève A, Colin M, Lesne F, Guinard J, Ar Gouilh M, Dina J, Vabret A, Hocqueloux L. Effect of Tenofovir Disoproxil Fumarate and Emtricitabine on nasopharyngeal SARS-CoV-2 viral load burden amongst outpatients with COVID-19: A pilot, randomized, open-label phase 2 trial. EClinicalMedicine. 2021 Aug;38:100993. doi: 10.1016/j.eclinm.2021.100993. Epub 2021 Jun 27.

family: Parienti

full_name: Jean-Jacques Parienti

given: Jean-Jacques

family: Prazuck

full_name: Thierry Prazuck

given: Thierry

family: Peyro-Saint-Paul

full_name: Laure Peyro-Saint-Paul

given: Laure

family: Fournier

full_name: Anna Fournier

given: Anna

family: Valentin

full_name: Cécile Valentin

given: Cécile

family: Brucato

full_name: Sylvie Brucato

given: Sylvie

family: Verdon

full_name: Renaud Verdon

given: Renaud

family: Sève

full_name: Aymeric Sève

given: Aymeric

family: Colin

full_name: Mathilda Colin

given: Mathilda

family: Lesne

full_name: Fabien Lesne

given: Fabien

family: Guinard

full_name: Jérome Guinard

given: Jérome

family: Ar Gouilh

full_name: Meriadeg Ar Gouilh

given: Meriadeg

family: Dina

full_name: Julia Dina

given: Julia

family: Vabret

full_name: Astrid Vabret

given: Astrid

family: Hocqueloux

full_name: Laurent Hocqueloux

given: Laurent

journal_name: EClinicalMedicine

ipd_sharing_description: We encourage contact the corresponding author for academic IPD sharing

lead_sponsor: University Hospital, Caen

location_facility:
Regional Hospital
Caen University Hospital


title: Stereotactic Radiotherapy for Renal Cancers: Phase I Study

summary:
Stereotactic radiotherapy is a technique that allows the delivery of a high dose of radiation over few fractions (3-6) with great precision. It thus allows "tumor ablation" and optimal preservation of healthy tissues. Initially developed in small-sized (<5 cm) lung cancers this technique it gives results very close and or even equivalent to those of surgery.

Stereotactic radiotherapy of brain metastases of renal cancers has shown that high doses of radiation allows local control in 90 to 98% of cases. A study conducted in Sweden (Wersall et al.) underline the interest to develop stereotactic radiotherapy in primary renal tumors. In Cleveland (USA) two phase I studies are already underway.

The investigators propose to develop a phase I study for tumors of less than 4 cm. As found in lung cancers, stereotactic radiotherapy can provide a non-invasive, painless and rapid (4 to 5 fractions) method for the treatment of renal cancers with a high rate of local control.

The primary objective is to define the maximal tolerated dose for one fraction in stereotactic mode of renal tumors ≤ 4 cm in length using an a four-step dose increase:

Step 1: 4 x 8 Gy.
Step 2: 5 x 8 Gy.
Step 3: 4 x 10 Gy.
Step 4: 4 x 12 Gy.

The patients will be followed during treatment with evaluation of acute toxicities before each session, then at 15 days, 6 weeks, 3 months, 9 months, 12 months, and then every 6 months for a total duration of 5 years after treatment.

status: Active, not recruiting

lead_sponsor: Hospices Civils de Lyon

location_facility: Service d'Oncologie-Radiothérapie - Centre Hospitalier Lyon Sud - HCL

location_facility: Service de Radiothérapie - Centre Georges François Leclerc


title: Kinetics of the Plasmatic Concentration of L-Ascorbic Acid in Patient With Myelodysplastic Syndromes and Control Subjects

acronym: PLASMYC

summary:
Myelodysplastic syndromes (MDS) is a group of heterogeneous diseases characterised by the clonal evolution of dysplastic hematopoietic stem cells. This evolution is associated with accumulation of cytogenetic mutations which leads to acute myeloid leukaemia (AML). Evolution of MDS is also associated with increase of reactive oxygen species (ROS). The increase of ROS is associated with accumulation of cytogenetic mutations. Ascorbic acid (AA) is an actor of the regulation of the oxidative metabolism in the human body.

Studies showed that supplementation with AA can change the proliferation status of MDS cells. Adjuvant treatment with AA is associated with a beneficial effect on the evolution of MDS and AML. The present study aim at describing the variations of plasmatic ascorbic acid concentrations between healthy volunteers and patients with myelodysplastic syndromes advanced in their treatment or recently diagnosed during a follow-up of 12 months.

primary_purpose: Health Services Research

ReferenceCitation: Das A, Dey N, Ghosh A, Das T, Chatterjee IB. NAD(P)H: quinone oxidoreductase 1 deficiency conjoint with marginal vitamin C deficiency causes cigarette smoke induced myelodysplastic syndromes. PLoS One. 2011;6(5):e20590. doi: 10.1371/journal.pone.0020590. Epub 2011 May 31.

ReferenceCitation: Ghoti H, Amer J, Winder A, Rachmilewitz E, Fibach E. Oxidative stress in red blood cells, platelets and polymorphonuclear leukocytes from patients with myelodysplastic syndrome. Eur J Haematol. 2007 Dec;79(6):463-7. Epub 2007 Nov 1.

ReferenceCitation: Hole PS, Darley RL, Tonks A. Do reactive oxygen species play a role in myeloid leukemias? Blood. 2011 Jun 2;117(22):5816-26. doi: 10.1182/blood-2011-01-326025. Epub 2011 Mar 11. Review. Erratum in: Blood. 2014 Jan 30;123(5):798.

ReferenceCitation: Chung YJ, Robert C, Gough SM, Rassool FV, Aplan PD. Oxidative stress leads to increased mutation frequency in a murine model of myelodysplastic syndrome. Leuk Res. 2014 Jan;38(1):95-102. doi: 10.1016/j.leukres.2013.07.008. Epub 2013 Aug 16.

ReferenceCitation: Levine M, Rumsey SC, Daruwala R, Park JB, Wang Y. Criteria and recommendations for vitamin C intake. JAMA. 1999 Apr 21;281(15):1415-23.

ReferenceCitation: Park CH. Vitamin C in leukemia and preleukemia cell growth. Prog Clin Biol Res. 1988;259:321-30.

ReferenceCitation: Park CH, Kimler BF. Growth modulation of human leukemic, preleukemic, and myeloma progenitor cells by L-ascorbic acid. Am J Clin Nutr. 1991 Dec;54(6 Suppl):1241S-1246S. doi: 10.1093/ajcn/54.6.1241s.

ReferenceCitation: Park CH, Kimler BF, Bodensteiner D, Lynch SR, Hassanein RS. In vitro growth modulation by L-ascorbic acid of colony-forming cells from bone marrow of patients with myelodysplastic syndromes. Cancer Res. 1992 Aug 15;52(16):4458-66.

ReferenceCitation: Park CH, Kimler BF, Yi SY, Park SH, Kim K, Jung CW, Kim SH, Lee ER, Rha M, Kim S, Park MH, Lee SJ, Park HK, Lee MH, Yoon SS, Min YH, Kim BS, Kim JA, Kim WS. Depletion of L-ascorbic acid alternating with its supplementation in the treatment of patients with acute myeloid leukemia or myelodysplastic syndromes. Eur J Haematol. 2009 Aug;83(2):108-18. doi: 10.1111/j.1600-0609.2009.01252.x. Epub 2009 Mar 5.

ReferenceCitation: Parker JE, Fishlock KL, Mijovic A, Czepulkowski B, Pagliuca A, Mufti GJ. 'Low-risk' myelodysplastic syndrome is associated with excessive apoptosis and an increased ratio of pro- versus anti-apoptotic bcl-2-related proteins. Br J Haematol. 1998 Dec;103(4):1075-82.

ReferenceCitation: Parker JE, Mufti GJ, Rasool F, Mijovic A, Devereux S, Pagliuca A. The role of apoptosis, proliferation, and the Bcl-2-related proteins in the myelodysplastic syndromes and acute myeloid leukemia secondary to MDS. Blood. 2000 Dec 1;96(12):3932-8.

ReferenceCitation: Saito N, Miyamoto M, Gotoh U, Yoshitomi S. Effect of biscoclaurine alkaloids, prednisolone and ascorbic acid on myelodysplastic syndrome with pancytopenia: a case report. Eur J Haematol. 2000 Jan;64(1):61-5.

ReferenceCitation: Welch JS, Klco JM, Gao F, Procknow E, Uy GL, Stockerl-Goldstein KE, Abboud CN, Westervelt P, DiPersio JF, Hassan A, Cashen AF, Vij R. Combination decitabine, arsenic trioxide, and ascorbic acid for the treatment of myelodysplastic syndrome and acute myeloid leukemia: a phase I study. Am J Hematol. 2011 Sep;86(9):796-800. doi: 10.1002/ajh.22092. Epub 2011 Aug 3.

location_facility: Department of Haematology and Cell Therapy, University Hospital, Tours

location_facility: Clinical Research Center, University Hospital, Tours


title: Impact of the Change in Hospital Service of Caregivers During COVID-19 Health Crisis on Operational Strain

acronym: CovIdeDocS

summary:
The French Armed Forces Health Service caregivers are confronted with specific operational constraints that require physiological adaptation on a daily basis. These constraints generate an allostatic load resulting from the body's adaptation to the environment through stress response systems. The COVID-19 health crisis has modified the physical and psychological constraints linked to usual activity, in particular by imposing versatility to caregivers.

The research hypothesis is that carers who have undergone activity reorganisations, and in particular a change of service, are more affected by the health crisis than those who have remained in their service and have continued an activity close to their usual practice.

lead_sponsor: Direction Centrale du Service de Santé des Armées

location_facility: Institut de Recherche Biomédicale des Armées


title: Impact of Male Smoking on the Couple's Infertility: Two-centre Case-control Study

acronym: TABAFERTIMASC

summary:
About 15% of couples consult for difficulties achieving pregnancy. In about two-thirds of cases, a male component is identified, but is not always sufficient to explain infertility. In the majority of cases, the cause cannot be clearly identified and multiple abnormalities may be detected in both partners.

Many factors concerning lifestyle and environment (medications, alcohol, smoking, pollution, exposure to heat, toxins, xenobiotic oestrogens, etc.) may impact on fertility. These factors may also impact on the fertility of the children conceived, which is described as an intergenerational effect (alteration of the fertility of boys exposed to smoking in utero).

Few scientific studies with a high level of proof have been published on the impact of smoking on the couple's fertility. Gonadal functioning and the quality of gametes can be altered by these environmental factors, which may trigger a process of apoptosis or alteration of the DNA of gametes (sperm DNA fragmentation). Other modifications include DNA methylation and histone acetylation, which control gene expression and are grouped under the term epigenetic modifications. More recently, oestrogens has been shown to be involved in male reproductive function by acting on spermatogenesis, spermiogenesis and epididymal maturation. Demonstration of an active aromatase (Arom) (mRNA, protein and activity) in ejaculated human spermatozoa suggests the synthesis of small quantities of oestrogens in spermatozoa. The study of transcript profiles could provide information about the quality of spermatogenesis and/or spermiogenesis and during the first steps of embryonic development. Confocal microscopy has colocalized the aromatase on the head, midpiece and tail and can be used to assess the quality of the acrosome with anti-CD-46 monoclonal antibody. Even low concentrations of xenobiotic oestrogens can exert biological effects on certain functions of murine or human spermatozoa, accelerating capacitation and the acrosome reaction. These factors are all the more effective when they act in combination, as human gametes appear to be more sensitive to their action than murine gametes All studies conducted to date have investigated the impact of toxins either on one of the partners or in the children born to the couple. No detailed and high-level scientific study has studied both partners and the quality of their embryos.

location_facility:
CHU Caen
CHU Amiens


title: Assessment of Post-traumatic Stress Disorder (PTSD) in Patients Monitored for Cytomegalovirus (CMV) Seroconversion During Pregnancy, Without Ultrasound Signs or With Non-serious Ultrasound Signs of Maternal-fetal CMV Infection.

acronym: PTSD CMV

summary:
Reports of maternal seroconversion to CMV during pregnancy can be extremely stressful. This virus is little known to the general public and searching for information on the Internet quickly leads to a consultation of a site mentioning the risk of severe psychomotor retardation in the event of prenatal cytomegalovirus infection.

The psychological repercussions in the event of prenatal CMV infection with criteria of severity, leading or not to a request for IMG, is undeniable, but no study has investigated the consequences of seroconversion to CMV without transmission of the virus to the patient fetus, or in the case of transmission without criteria of seriousness, on the patient's experience during and after her pregnancy. Such a study would, if necessary, improve the care and support of these future mothers

location_facility: Service de Gynécologie Obstétrique, Hôpital Lyon Sud

location_facility: Service de Gynécologie Obstétrique, Hôpital Mère Enfant


title: Evaluation of the Efficacy of Citrulline Supplementation on the Delay of Delivery for Women Hospitalized for Pre-eclampsia (CITRUPE)

acronym: CITRUPE

summary:
Pre-eclampsia (PE) complicates 2-8 % of pregnancies and is associated with high maternal and fetal morbidity and mortality. The early clinical manifestations are the occurrence of a maternal blood pressure and proteinuria. Placental dysfunction impairs the nutrient supply to the fetus, and may be the cause of an intrauterine growth retardation (IUGR). This is a disease that causes prematurity and currently the only known cure is delivery of the placenta. Nitrogen monoxide (NO) regulates the placental blood flow. However, pre-eclampsia is directly related to a failure of placental NO production. In this context, several clinical trials have tested the effect of NO donors such as L- arginine. However, supplementation with L -Arginine in a randomized trial in Nantes, has proved to be ineffective in severe vascular IUGR.

Citrulline is a natural aminoacid precursor to arginine and in contrast to L-arginine escapes uptake in the liver and appears directly in the peripheral blood converted by the kidney in arginine, released into the systemic circulation, Citrulline may therefore be more effective in the treatment of pre-eclampsia.

This prospective, randomized, comparative and double-blinded study aims to prolong pregnancy for patients with pre-eclampsia before 36 weeks.

location_facility:
Hôpital Cochin (Maternité Port-Royal)
CHU de Nantes


title: Evaluation of pupillometrY for External Ventricular Drains Stop

acronym: EYES

summary:
Placement of an external ventricular shunt is one of the most common neurosurgical procedures in neuro-resuscitation. However, the modalities of its withdrawal are not, the subject of recommendations but rather of service habits. It has been recently demonstrated that pupillary monitoring by an electronic pupillometer was more reliable than standard clinical monitoring in brain injury patients. This tool provides access to a rich pupillary semiology at the patient's bed.

So the goal is to study the evolution of the various pupillary parameters analyzed by the electronic pupillometer during the external ventricular shunt weaning tests and to highlight the predictive factors of failure.

lead_sponsor: Centre Hospitalier Universitaire de la Réunion

location_facility:
Hôpital La Timone
CHU de la Réunion


title: Comparison of Bone Quality in Type 2 Diabetic Patients With a Non-diabetic Control Population

acronym: DIABONE

summary:
Patients with type 2 diabetes have many complications in different organs. These complications are extremely frequent and severe: cardiovascular and renal disease, visual impairment, and, more recently, complications affecting bone such as fractures. Conventional methods for the evaluation of fracture risk are based on the Bone Mineral Density (BMD) or FRAX (algorithm for the prediction of osteoporotic fracture risk) are not sufficient in the context of diabetes. Several metaanalyses have shown that, paradoxically, a higher BMD in patients with type 2 diabetes compared to patients not suffering from this disease, independently of body mass index (BMI). The paradoxal increase in fracture risk, despite a high BMD has led to the hypothesis that diabetes induces a modification of the quality and not the quantity of bone. However, there is a lack of data as to bone quality in patients with type 2 diabetes as studies of bone biopsies from patients with type 2 diabetes are extremely rare.

The objective of the study is to compare bone quality in patients with type 2 diabetes to that in patients who do not suffer from type 2 diabetes: evaluation of vertebral fractures by osteodensitometry, measurement of Trabecular Bone Score (TBS), and analysis of bone quality in biopsies (advanced glycation end products (AGE), contents of bone matrix and analysis of mineralization).

The results will then be correlated with blood/urinary markers with the objective to determine one/several non-invasive biomarkers for bone status in diabetic patients.

location_facility: Hôpital Edouard Herriot, Hospices Civisl de Lyon


title: IMCY-NMO-000 In Vitro Study of the Biological and Immunological Activity of Imotopes® Candidates on Blood Cells of Patients With Stabilized Neuromyelitis Optica (PHASE 0)

summary:
This is a fundamental, prospective, multi-centres, interventional non-comparative study without the administration of a study product to patients.

A phase 0 study is particularly well adapted to early exploration of potential targeted treatments - i.e. treatments whose efficacy can only be hoped for in patients presenting specific biological characteristics in addition to being diagnosed with the targeted disease, Neuromyelitis Optica Spectrum Disorders (NMOSD) in this study. The main goal of the study will be to support the selection of Imotopes® (i.e. synthetic peptides encompassing HLA Class II T epitopes flanked by a thioreductase motif), and (i) capable of binding with class II HLA antigens of each patient and (ii) causing ex vivo the appearance of epitope -specific cytolytic CD4+ T cells.

lead_sponsor: Imcyse SA

location_facility:
Hôpital Pierre Wertheimer
Hôpital de Hautepierre


title: Consequences of a Brain Lesion or of Migraine on Auditory Processing: Attention, Memory and Emotion

summary: The project studies auditory processing after brain damage (in temporal and/or frontal areas) and in migraine. The auditory processes investigated are attention, short-term memory, sound-induced emotions. To characterize auditory deficits after brain damage or in migraine, neuropsychological assessments are combined with neurophysiological markers (Electro-encephalography: EEG, Magneto-encephalography: MEG, Magnetic Resonance Imaging: MRI).

ReferenceCitation: Masson R, Demarquay G, Meunier D, Lévêque Y, Hannoun S, Bidet-Caulet A, Caclin A. Is Migraine Associated to Brain Anatomical Alterations? New Data and Coordinate-Based Meta-analysis. Brain Topogr. 2021 May;34(3):384-401. doi: 10.1007/s10548-021-00824-6. Epub 2021 Feb 19.

family: Masson

full_name: Rémy Masson

given: Rémy

family: Demarquay

full_name: Geneviève Demarquay

given: Geneviève

family: Meunier

full_name: David Meunier

given: David

family: Lévêque

full_name: Yohana Lévêque

given: Yohana

family: Hannoun

full_name: Salem Hannoun

given: Salem

family: Bidet-Caulet

full_name: Aurélie Bidet-Caulet

given: Aurélie

family: Caclin

full_name: Anne Caclin

given: Anne

journal_name: Brain Topography

publisher: Springer Science and Business Media LLC

publisher_dissemination: Springer-Nature

publisher_group: Springer-Nature

publisher_normalized: Springer

location_facility: Service Explorations Fonctionnelles Neurologiques, Hôpital de la Croix-Rousse