title: Women and Women's Hygienic Protection: Evaluation of Women's Practices, Knowledge and Expectations for Intimate Protection

summary:
Intimate protections are designed to absorb menstrual flow during menstruation. A woman will use an average of 6,000 intimate protections during her lifetime. Intimate protections are classified into two categories: internal intimate protections including tampon, menstrual cup, menstrual sponge, and external intimate protections including disposable or washable sanitary pads, panty liner, menstrual panty. The choice and use of a type of intimate protection will depend on multiple factors specific to each woman. Due to a growing media interest in this area, women have become extremely critical and suspicious of these devices, particularly about the Toxic Shock Syndrome, attributed to the use of tampon in women previously colonized vaginally by strain of toxin-producing Staphylococcus aureus (Toxic shock syndrome toxin-1 (TSST-1)). Similarly, chemical residues have been found in sanitary napkins.

As a result, women's expectations have changed and there is a greater demand for transparency with regard to intimate protection of their composition and their potential health risks. Women want more and more alternative to conventional intimate protections in today's climate of increasing environmental awareness.

It is a cross-sectional, observational, prospective, unicentric inclusion study (CHU de Reims). The primary objective is to describe women's intimate protection practices. The secondary objectives are to study the determinants of women's choice for intimate protection, to describe women's knowledge of the potential risks of these intimate protections. and women's information sources on intimate protections. Finally describe the expectations of women in terms of intimate protections. The results are intended to give a photograph of the practices and knowledge of women consulting in the Obstetrics and Gynecology Department of the University Hospital of Reims concerning intimate protections.

Patients aged 18 to 50, presenting menstrual cycles, consulting in the obstetrics and gynecology department of the University Hospital of Reims whatever the reason for consultation can participate in the study after signing the consent of no opposition. Participation in the study will not change the patient's medical management. Participation in the study will result in the completion of a questionnaire concerning intimate protections. The filling time of the questionnaire is estimated at 10 minutes.

This subject is evolving with a growing awareness of women on the management of their rules, the products used, their potential risks and the environment. This study will allow us to see if women are really informed and feel concerned by these changes. And in the end, find out if they are ready to turn to intimate protections called "alternatives" The results will give us a vision of the expectations of our patients in this area as well as the information received, and thus allow us to publish an information guide and good practices of the intimate protections available in the waiting rooms of our consultations.

In addition, this study will allow health professionals to discuss this subject more easily and easily with their patients.

lead_sponsor: CHU de Reims


title: Thuflep/SOLEP : Initial Experience and Results of Prostate Laser Enucleation With Thulium-fiber Laser (TFL)

summary: Thuflep TLF: initial experience and results of prostate laser enucleation with fibrous thulium laser (TLF)

study_start_date_type: Actual

status: Completed

study_completion_date_type: Actual

study_type: Observational

time_perspective: Prospective

enrollment_type: Actual

lead_sponsor: Clinique Saint-Hilaire

lead_sponsor_type: industriel

status_simplified: Completed


type: Other Identifier

title: Different Approaches to Thoracic Paravertebral Block: a Monocentric Randomized Study Comparing Ultrasounded-guided Method to Intrathoracic Visual Method

acronym: VAP BLOCK

summary: Thoracic paravertebral block (TPB) in thoracic surgery is practiced since the development of minimally invasive surgery. Historically, thoracic epidural analgesia is done in open thoracic surgery. Thoracotomy with rib spacing causes strong post-operative pain that is well controlled with epidural analgesia and allows less use of morphine. However, this method causes frequent side effects. Minimally invasive surgery, when it is possible and recommended, has the main benefit of not spacing the ribs and therefore preventing nerve stretching, rib fractures and less post-operative pain. This less aggressive method has other benefits: less inflammation, better recuperation especially for vulnerable patients (the elderly; limited pulmonary functions), less time of thoracic drainage, less in hospital stay and better quality of life (1). Less invasive surgery has brought us to use less invasive analgesic methods. Thoracic paravertebral block is a good alternative to thoracic epidural analgesia but is unfortunately not done everywhere due to the lack and need of professional training. The objective of our study is to compare two methods of TPB: ultrasound guided method undergone by the anesthesiologist, and intrathoracic method undergone through video assisted surgery (VATS) or robotic assisted surgery (RATS).

study_type: Interventional

design_allocation: Randomized

primary_purpose: Other

lead_sponsor: Assistance Publique Hopitaux De Marseille

location_facility: assistance publique hôpitaux de Marseille

intervention_type: Procedure

lead_sponsor_type: academique


title: ROLE OF IMMUNE ACTIVATION PROFILES IN CORONARY ATHEROTHROMBOSIS IN PATIENTS HIV-1-INFECTED ON EFFECTIVE ANTIRETROVIRAL THERAPY

acronym: CoroVIH

summary: HIV-infected patients with intermediate-high risk have a high prevalence of CAD and a substantial proportion of obstructive CAD. Degree of stenosis is associated with immunoactivation (lymphocyte and monocyte) and microbial translocation

status: Recruiting

study_completion_date_type: Anticipated

enrollment_type: Anticipated

ipd_sharing: No

lead_sponsor: Hôpital Européen Marseille

intervention_type: Other

status_simplified: Ongoing


title: A Prospective, Observational (Non-interventional), International Study to Assess Conservative Treatments Effectiveness in Acute Phase of Hemorrhoidal Disease

acronym: CHORALIS

summary: The primary objective of this study is to assess in real-life setting the effectiveness of conservative treatments on signs, symptoms and quality of life in patients consulting for hemorrhoids in acute phase of the disease

lead_sponsor: Servier Affaires Médicales


type: Registry Identifier

title: Immune Profiles Evolution in Patients Treated by Immunotherapy for Melanoma

acronym: EPITHEM

summary: The primary objective of the study aims to compare the immune profiles (circulating cytokines and lymphocytes) before and after (6 to 8 weeks) the first infusion of immune checkpoint inhibitors in patients with melanoma treated in the adjuvant setting(cohort A) or in metastatic setting(cohort B); and to study the association of these immune profiles with relapse- or progression-free survival.

design_allocation: Non-Randomized

primary_purpose: Treatment

lead_sponsor: Assistance Publique - Hôpitaux de Paris

location_facility: Dermato-oncology department, Ambroise Paré hospital, APHP


title: How Bariatric Surgery Impacts Pelvic Floor Disorders Evolution : Analysis on a Cohort From a French Hospital.

acronym: ICONES

summary: Bariatric surgery is increasingly practiced, as it is the most efficient treatment for morbid obesity. More than eighty percent of the operated patients are women. Nethertheless, few is known about gynecologic long-term impact of such surgeries, especially regarding pelvic floor disorders (PFD). This work aims at studying the evolution of PFD in women following a bariatric surgery more than 18 months ago in a French university center Hospital.

lead_sponsor: Poitiers University Hospital


title: Prevalence of COVID-19 Infection in a Cohort of Patient Infected by the HIV and Patients Taking PrEP Pre-exposure Prophylaxis

summary: The purpose of the study is to assess seroprevalence of COVID-19 infection in a cohort of HIV + patients and in a cohort of patients taking PrEP by emtricitabine / tenofovir.

study_start_date_type: Anticipated

status: Unknown status

intervention_type: Diagnostic Test

status_simplified: Unknown


title: Translational and Multimodal Brain Imaging of the Neural Correlates of Arousal and Awareness During Coma and Post-coma

acronym: IMAGINA

summary:
In last decades, several advances in the neuro-intensive management have lead to decrease mortality in Intensive Care Units. A significant morbidity remains as patients survive after a traumatic coma with uncertain quality of awakening and a high risk of functional disability. Predicting awareness recovery and functional disability of those who will awake constitutes a major challenge to inform patients' relatives, to give the best chances in terms of rehabilitation resources or to adapt intensive cares to a reasonable level. Tools currently available are not sufficient neither to predict bad awakening outcome nor to predict good functional outcome. In many countries, life's support cessation is a constant call for robust evaluation as soon as possible in ICU but it is mandatory to reach a positive predictive value of non-awaking close to 100%. Many clinical, electro-physiological, biological, radiological and functional parameters have been conducted with comatose patients assuming the purpose to predict outcome. Regarding unfavourable outcome, the gold standard is the abolition of the N20 component of somatosensory evoked potentials but the specificity is high enough only for patients with anoxic coma. Several neurophysiological markers such as MMN, P300 are correlated to a favourable outcome but the sensitivity and specificity remains low for patients who suffered a severe traumatic brain injury. New Diffusion Tensor imaging sequences provide complementary information to detect small structural lesions (diffuse axonal lesions). Recently, functional MRI analyzing Resting State has also been proposed as a prognostic marker during coma. PET using Fluoro-Desoxy-Glucose is able to assess the metabolism in key regions of the awakening network in either anaesthesia or sleep. Recent studies have reported interesting results at the chronic stage but to our knowledge, these tools have only been used to address pathophysiology's issues and never to improve coma prognosis at the initial stage. We hypothesize that the heterogeneity of the population requires a global and accurate assessment of the central nervous system, combining structural, metabolic and functional information in order to refine the prognosis.

Our protocol integrates in one-sequence most radiological markers of brain injury within a unique PET-MRI in Lyon. Our most relevant originality consists in confronting FDG-PET and MRI sequences to a large clinical, electrophysiological and biological battery. The added clinical value would be to question the synergistic effect of each parameter and to find out which ones are the most useful for awakening prediction, as they have not been compared in a multi-parametric database.

PET-MRI, as a new device combining physiological and prognostic questioning, allows us:

to implement a more integrative physio-pathological analysis
to avoid the cofounding effect of awareness' fluctuations in recording simultaneously multiple functional imaging techniques.

The RS will be analyzed at 2 epochs in order to assess the stability of brain connectivity, related to neuronal activity (glucose metabolism) and brain perfusion.

The interest of imaging result will be compared across morphological and functional sequences and in comparison, to classical marker (clinical, electrophysiological and behavioural) to build the most precise prognostic tool for acute comatose patients in ICU or diagnostic/prognostic tool for chronic patients in rehabilitation unit.

status: Not yet recruiting

lead_sponsor: Hospices Civils de Lyon


title: RPSA as a Potential Prognostic Biomarker of PDAC

acronym: PaCaBioMarkeR

summary:
PDAC (Pancreatic ductal adenocarcinoma) represents 90% of pancreatic tumors. The prognosis of PDAC remains poor at this time. Its management is based on surgery for early stages, associated with neoadjuvant and adjuvant chemotherapy. However, around 80% of patients will relapse after surgery. There is a lack of efficient biological biomarkers of PDAC, especially for prognosis. To date, CA19-9 is commonly used despite its lack of sensitivity and specificity.

Ribosomal protein SA (RPSA) is a transmembrane receptor localized at the cell surface but also in the cytosolic and nuclear regions. RPSA interacts with many proteins in the extracellular matrix (ECM), including laminin-1 and elastin. RPSA in involved in different cellular functions such as cell adhesion, migration, proliferation and differentiation. The expression of RPSA is increased in many cancers including breast, lung, prostate, pancreatic, etc. It could represent a molecular biomarker of tumor invasion and metastatic abilities. Moreover, the concentration of RPSA could be measured in the serum of patients with PDAC. Recent data suggest that a modification of the RPSA concentration could be a prognostic biomarker of PDAC.

primary_purpose: Diagnostic


title: Early Prenatal Interview : Throwback to the Hospital of Montpellier's Experience and Description of the Psychiatric Care Pathway of Pregnant Women.

summary:
Pregnancy and postpartum are recognized as periods of psychic fragility. However, the psychiatric disorders of women that can emerge during these periods are underdiagnosed and have consequences in particular on the development of the child, his relationship with his parents.

The need for an early diagnosis to allow appropriate treatment seems to be essential.

The pregnancy monitoring is centered on the somatic and little on psychological evaluation of the mother and the father.

In this context, the Early Prenatal Interview (EPP) was created through the perinatal plan of 2005-2007 in order to allow a more precise research of the factors of vulnerabilities likely to be predictive of a somatic, psychological or social disorder.

However, until now, only few pregnant women benefited of this interview. In May 2020, EPP became mandatory for all pregnant women. It now seems important to clearly identify the place, function, organization and usefulness of this interview in order to maximize its benefit in the monitoring of pregnancy

time_perspective: Retrospective

ipd_sharing: Undecided

ipd_sharing_description: NC

lead_sponsor: University Hospital, Montpellier


title: A Prospective, Observational (Non-interventional), International Study to Assess Effectiveness of Conservative Treatments in Chronic Venous Disease

acronym: VEIN STEP

summary: The primary objective of this study is to assess in real-life settings the effectiveness of conservative treatments on symptoms, signs and quality of life, in patients consulting for CVD


title: Randomized, Open-label Bioavailability Study of the Kinetics of Plasma, Urinary and Salivary Concentrations of Melatonin and 6-sulfatoxymelatonin Subsequent to the Consumption of Melatonin-rich Food Supplements With Different Galenic Forms

summary: This study is conducted to clinically document the melatonin bioavailability of two dietary supplements containing melatonin : one prolonged release tablet dosed at 1.9mg and one spray dosed at 1mg for 2 oral sprays.

primary_purpose: Basic Science

ipd_sharing_description: no sharing

lead_sponsor: PiLeJe

intervention_type: Dietary Supplement


title: Impact of the Eurékoi Serious Game on Family Caregivers of Patients With a Major Neurocognitive Disorder

summary: This study aims to assess the effectiveness of serious EUREKOI gambling on the anxiety of family caregivers of patients with newly diagnosed Alzheimer's disease.

lead_sponsor: Centre Hospitalier Universitaire de Nice

intervention_type: Behavioral


title: PsyDoMa :Non-drug Approaches at Home for Alzheimer's Patients With Psycho-behavioural Disorders and Psycho-education for the Caregivers

acronym: PSYDOMA

summary:
Recruitment is carried out directly at the geriatric unit of the CIMIEZ University Hospital Center by geriatric doctors during day consultation or in short stay unit. The doctor wil select carer -patient couples more likely to take part in the study. The investigator will give them an informative leaflet and they will have to sign the consent form.

A diagnosis is made by the investigator. The patient will first have to undergo a neurocognitive assessment carried out at the Cimiez Hospital (test for the evaluation of a cognitive deficit) by a psychologist.

The non-drug approaches presented will be carried out directly at the participant's home with the help of the carer for therapeutic purposes.

The therapeutic objectives and the choice of approaches are specified within the Personalised Accompaniment Project (PAP).

The carer, if he or she wishes, participates in the sessions in order to reproduce the behaviours implemented by the psychologist.

Different workshops will be offered : Cooking, Art Therapy, Games, Multi-sensory, Soft Gymnastic, Relaxation, Music and Reminisence.

Patients will received three visits per week during six months. The carer will receive one visit per week for six months.

primary_purpose: Health Services Research


title: Development of a Tele-monitoring Program for Patients Undergoing Surgery for Pheochromocytoma and / or Paraganglioma

acronym: e-PPGL

summary:
Pheochromocytomas and paragangliomas (PPGL) are rare tumors treated by surgical excision. During follow-up, more than 15% of patients will have recurrences in the form of new tumors, locoregional recurrence or metastases. This subgroup is initially not identifiable. It is therefore usual to perform annual monitoring of all patients throughout their lives by questioning and measuring blood pressure during a medical consultation and by measuring urinary or plasma metanephrines and normetanephrines.

The main objective of this prospective monocentric study is to evaluate the reliability of an optimized remote monitoring program in comparison to a usual in-clinic monitoring of patients surgically-cured and tumor-free at the time of inclusion.

ReferenceType: background

ReferenceCitation: Amar L, Fassnacht M, Gimenez-Roqueplo AP, Januszewicz A, Prejbisz A, Timmers H, Plouin PF. Long-term postoperative follow-up in patients with apparently benign pheochromocytoma and paraganglioma. Horm Metab Res. 2012 May;44(5):385-9. doi: 10.1055/s-0031-1301339. Epub 2012 Feb 20. Review.

ReferenceCitation: Plouin PF, Amar L, Dekkers OM, Fassnacht M, Gimenez-Roqueplo AP, Lenders JW, Lussey-Lepoutre C, Steichen O; Guideline Working Group. European Society of Endocrinology Clinical Practice Guideline for long-term follow-up of patients operated on for a phaeochromocytoma or a paraganglioma. Eur J Endocrinol. 2016 May;174(5):G1-G10. doi: 10.1530/EJE-16-0033. Review.

ipd_sharing: Yes


title: FAME 1: The Effects of Apathy on Different Forms of Fatigue

summary:
60 participants with light neuro-cognitive disorders (30 apathetic, 30 non-apathetic) will be recruited from the CMRR (Centre Mémoire Ressources et Recherche) in Nice University Hospital and from the " Fragilily " Platform of the Nice University Hospital.

After verification by the investigator, if they meet the inclusion criteria and sign the informed consent, participants will have to wear an actigraph for one week in order to measure their level of activity.

Afterwards, participants will have to complete assessments and questionnaires to evaluate apathy (Apathy Motivation Index, Apathy Inventory), perceived fatigue (Fatigue Severity Scale, Borg scale), fatigability (6-min walking test, isometric strength test, double task), the stress level (Perceived Stress Scale) and depression (Geriatric Depression Scale).

Regarding the activity level, they will also be asked to perform tasks to evaluate their kinematic movements( through an actigraph), and their particular sensitivity towards effort and reward (through serious game 'Tap-piscine').

The total duration of the evaluation is a maximum of 2 hours.

ReferenceType: derived

ReferenceCitation: Daumas L, Zory R, Robert P, Manera V. Apathetic patients with neurocognitive disorders are more fatigued and fatigable. Aging Clin Exp Res. 2022 Sep;34(9):2237-2241. doi: 10.1007/s40520-022-02146-4. Epub 2022 May 24.

location_facility: Centre Memoire Ressources et Recherche, CHU de Nice


title: Efficacy and Safety of Transcutaneous Tibial Neuro-stimulation to Improve Voiding Dysfunction in Multiple Sclerosis Patients.

summary:
The present trial is designed to assess the efficacy and safety of transcutaneous tibial neuro-stimulation (TTNS) in improving bladder emptying in multiple sclerosis (MS) patients.

Patients presenting with MS and performing clean intermittent self-catheterization (CISC) to empty the bladder in the context of voiding dysfunction, will be eligible.

Included patients will be randomly assigned to two distinct arms

PTNS de verum : patients will be treated with transcutaneous tibial neuro-stimulation at a rate of one session of 30 consecutive minutes daily for a period of 12 weeks.
PTNS placebo : Patients will be treated with placebo (i.e. no current) transcutaneous tibial neuro-stimulation for 30 consecutive minutes daily for a period of 12 weeks (same treatment regimen as the experimental group).

Efficacy in improving voiding dysfunction will be assessed 12 weeks after randomization using the BVE ratio (Bladder Voiding Efficiency) = Ratio of urine volume / total bladder volume.

lead_sponsor: University Hospital, Lille

intervention_type: Device


title: Benefit of a Systematic Proposition of Nicotine Replacement Therapy Preoperatively for Patients Undergoing Planned Surgery and With Tobacco or Cannabis Addiction, Regardless of the Intention to Quit

acronym: PATCHIR

summary:
Smoking is associated with a higher rate of surgical complications. For example, in orthopedics, the risk of complications is 31% in smokers against 5% in non-smokers. The management of this addiction is recommended and particularly interesting in scheduled surgery, because it allows smoking cessation well before the procedure. However, for patients who cannot consider this smoking cessation, the mere information of the risk cannot be sufficient and a real strategy must be constructed and evaluated.

Currently, studies results indicate that a patient reducing the number of smoked cigarettes will unconsciously modify their smoking behaviour to obtain the usual nicotine level, this effect is called self-titration. Conversely, nicotine replacement while continuing consumption could induce an improvement in smoking behaviour, therefore less intoxication which would be beneficial in terms of reduction of post-operative complications. This study seeks to assess the effectiveness of a systematic proposition of nicotine replacement therapy (NRT) in regular smokers. Tobacco addiction specialists have demonstrated that intoxication and dependence are well correlated with the exhaled carbon monoxide (CO) level, so this measurement will be used in addition to the patient's interview.

primary_purpose: Prevention

lead_sponsor: Groupe Hospitalier Mutualiste de Grenoble

location_facility: Groupe hospitalier Mutualiste de Grenoble


title: Validation of a Biomathematical Model to Help Identify the Parameters of Flexible Insulin Therapy: Monocentric, Controlled, Randomized and Prospective Pilot Clinical Study in Patients With Type 1 Diabetes.

acronym: ModIF

summary:
Type 1 diabetes is an autoimmune disease that requires daily treatment with insulin. The use of subcutaneous pumps for continuous insulin delivery has been an important advance for diabetic patients. The evolution of technologies through the miniaturization of insulin pumps and the advent of continuous glucose sensors has made it possible to understand the development of the artificial pancreas. Several teams are working on the development of an artificial pancreas with considerable progress in closed-loop insulin delivery, particularly during the night.

The Laboratory of Digital Sciences of Nantes has developed a new bio-mathematical model describing the glucose-insulin dynamics, closer to the physiological reality of patients with type 1 diabetes. This model allows firstly to identify the parameters of flexible insulin therapy (basal rate, insulin sensitivity, carbohydrate ratios).

The objective of this study is to test the relevance of this bio-mathematical model to help the physician identify the parameters of flexible insulin therapy (basal rate, insulin sensitivity, carbohydrate ratios).

ReferenceCitation: Scharbarg E, Greck J, Le Carpentier E, Chaillous L, Moog CH. A metamodel-based flexible insulin therapy for type 1 diabetes patients subjected to aerobic physical activity. Sci Rep. 2022 May 16;12(1):8017. doi: 10.1038/s41598-022-11772-x.

lead_sponsor: Nantes University Hospital


title: Interest of Improving Preoperative Medical Information by Video Support and Personalized and Secure Web Platform: Pilot Study in Thyroid Surgery (AMEDOP)

acronym: AMEDOP

summary:
The medical information delivered to the patient before any surgery constitutes an essential and compulsory step during the initial management of the operated patient.

There are different reasons for the quantity and quality of medical information retained by the patient. An internet platform with personalized and secure access has been developed. This platform contains, among other things, an explanatory video of thyroid surgery and allows the patient to have access to information on surgical management at any time.

The investigators believe that unlimited access for the duration of the study to this platform could reduce the preoperative anxiety level of patients.

primary_purpose: Supportive Care


title: Effects of Auditory Brain Stimulation by "Pink Noise" on Memory Capacities in Alzheimer's Disease: Proof of Concept Study

acronym: PINK-AD

summary:
Alzheimer's disease (AD) is a neurodegenerative disorder affecting almost 6% of the world's population over the age of 65. This disease, in its most typical sporadic form, is characterized by an episodic memory impairment linked to a deficit in consolidation. Many studies indicate that sleep promotes this consolidation stage during the deep slow sleep stage by facilitating the transfer of information between the hippocampus and the neocortex.

A method of acoustic brain stimulation at night by pink noises has been recently developed and has shown its effectiveness in strengthening memory consolidation in healthy volunteers. Actually, there is no study observing the effect of this new stimulation method on populations with neurodegenerative pathologies, in particular in AD for which this technique could potentially become a therapeutic option.

The hypothesis is that of a strengthening of the memory consolidation capacities in subjects with AD as has been shown in healthy subjects.

lead_sponsor: University Hospital, Tours


title: MRI Biomarkers in Diabetic Kidney Disease

acronym: MR3T - DKD

summary: Diabetic kidney disease is one of the most severe and frequent complications of diabetes. Few preclinical markers are available apart from plasma creatinine and microalbuminuria. These markers are imperfect (some patients with advanced renal disease do not have an increase in markers) and late. Therefor there is an uncovered need to identify complementary biomarkers. Magnetic Resonance Spectroscopy (MRS) is a Magnetic Resonance Imaging (MRI) technique that allows the physiology and biochemistry of human body tissues to be studied in a non-invasive and non-irradiating manner.

time_perspective: Cross-Sectional


title: Measurement of the Plasmatic TFPI Level in Haemophilia Patients and Correlation With Thrombin Generation Assay (TGA) Parameters

summary:
The goal of this study is to measure the TFPI plasma level, a molecule involved in the regulation of the coagulation system, in haemophilia patients. The second objective is to assess the effects of TFPI inhibition on thrombin generation. Indeed, there is sparse data on the physiological and pathological changes of TFPI levels in human and particularly in hemophilia patients. Yet, TFPI inhibitors may become one of the new by-passing treatments of haemophilia. Until now, published data mainly reports in vitro pharmacodynamics and pharmacokinetics of TFPI inhibitors. Hence, in vivo effects of TFPI inhibition remain unclear, especially in haemophilia patients.

The clinical development of such molecules requires a dedicated biological monitoring. Thrombin Generation Assay (TGA) in Poor Platelets Plasma (PPP) is a good candidate since it is sensitive to Factor VIII and Factor IX deficiencies as well as to TFPI. However, TGA results are very dependent on experimental conditions (i. e. Tissue Factor and phospholipids concentrations) and the relationship between TFPI plasma level and TGA parameters has not been studied yet. This study should provide with original data on TFPI plasma levels and the effect of TFPI on thrombin generation in haemophilia patients. This should help to define the monitoring of TFPI inhibitors in Haemophilia.


title: Non Enhanced Labyrinth Imaging for the Detection of Endolymphatic Hydrops in Meniere's Disease "NELI Study"

acronym: NELI

summary:
This study includes 30 patients with Meniere's disease confirmed with AAO-HNS criteria.

The aim of this study is to compare the new optimized 3D FLAIR sequence developed at our site with a standard 3D FLAIR sequence performed 4h after a single intravenous dose of macrocyclic gadolinium-based contrast agents for the detection of endolymphatic hydrops.

The patients will be explored with the new 3D FLAIR optimized sequence before injection (method to validate) and again 4 hours after contrast media administration with the same sequence 3D FLAIR

lead_sponsor: University Hospital, Bordeaux


title: Impact of the Implementation of a qSOFA Score on the Care of Adult Patients Referred to the Emergency Department for Suspected Infection

summary: The Quick-SOFA score (qSOFA), identifies septic patients with a mortality risk higher than 10%. In our study all adult patients coming to the emergency for suspected infection are screened according to the qSOFA score on arrival. If qSOFA ≥ 2, the patient should be referred to emergency vital room, if the score <2, the patient will be in the box. The objectives are : 1) to evaluate the mortality at 28 days with the orientation, 2) to compare support time of medical contact and initiation of antibiotics according to the orientation in the emergency department.

primary_purpose: Screening

lead_sponsor: Centre Hospitalier Universitaire de Besancon


title: Evaluation of Biological Response to SARS-COV2 in Patients With Pre-existing Neurological Disease or With New Neurological Manifestations of COVID-19

summary: Patients with neurological or psychiatric symptoms or pre-existing disease will be sampled (blood for serum and DNA or saliva for DNA) at inclusion and at M6 (blood) and M12 (blood) depending on their pathology. Sampling will be done either at hospital if patient is on site for routine care or at home if no consultation is scheduled at hospital.

ReferenceCitation: Louapre C, Ibrahim M, Maillart E, Abdi B, Papeix C, Stankoff B, Dubessy AL, Bensa-Koscher C, Creange A, Chamekh Z, Lubetzki C, Marcelin AG, Corvol JC, Pourcher V; COVISEP and Bio-coco-neuroscience study group. Anti-CD20 therapies decrease humoral immune response to SARS-CoV-2 in patients with multiple sclerosis or neuromyelitis optica spectrum disorders. J Neurol Neurosurg Psychiatry. 2022 Jan;93(1):24-31. doi: 10.1136/jnnp-2021-326904. Epub 2021 Aug 2.


title: Impact of Moderate to Severe Pain in the Post-intervention Monitoring Room After Hemorrhoidectomy on the Length of Stay in the Outpatient Surgery Unit

summary:
The target rate for outpatient surgery has been set by the Ministry of Health at 70% for 2020. To achieve this objective, this requires increasing the panel of eligible outpatient procedures to more mutilating surgeries and usually performed in conventional hospitalization. This switch from conventional hospitalization to an outpatient stay increases the risk of converting stays into unscheduled hospitalization. Postoperative pain is one of the main factors in converting outpatient stays. Poor control is associated with increased length of stay, and unscheduled consultations and readmissions. In addition, the increased time spent with severe pain during the first 24 hours postoperatively is a risk factor for chronicization.

Proctology, and, in particular, hemorrhoidal surgery is the perfect example. Outpatient management of open pedicle hemorrhoidectomy is increasing year by year, but the rate of conversion to unscheduled hospitalizations remains high. Urine retention, postoperative hemorrhage and poor pain control are the main causes. Within the Paris Saint Joseph Hospital Group, hemorrhoidal surgery has the highest rate of conversions from hospitalization to proctology (8% in 2019), despite the implementation since 2015 of a dedicated, developed according to the current recommendations of the SNFCP.

The pain after hemorrhoidal surgery is always severe in the absence of analgesics and appears upon arrival in the post-interventional monitoring room (SSPI). Despite the administration of analgesics or the implementation of locoregional analgesia techniques (pudendal block), moderate to severe pain is frequently observed in the post-intervention monitoring room. In the medical literature, there is little data evaluating the means of management of postoperative pain in this surgery, and even less the effect of the different associations.

Retrospectively and, from the data collected in our information systems, we wish to assess the impact on the length of stay of the presence of moderate to severe pain in the IPSS after a two-way or tri-pedicle hemorrhoidal surgery open on our cohort of patients operated in outpatient surgery. Our hypothesis is that the presence of moderate to severe pain in PPSS increases the total length of stay, placing the patient at an increased risk of conversion. The purpose of our study is also to identify predictive factors (aggravating or protective) of the onset of moderate to severe pain immediately after surgery, in order to establish a strategy to limit its frequency.

status: Active, not recruiting

ReferenceType: result

ReferenceCitation: American Society of Anesthesiologists Task Force on Acute Pain Management. Practice guidelines for acute pain management in the perioperative setting: an updated report by the American Society of Anesthesiologists Task Force on Acute Pain Management. Anesthesiology. 2012 Feb;116(2):248-73. doi: 10.1097/ALN.0b013e31823c1030.

ReferenceCitation: Vinson Bonnet B, Juguet F; French National Coloproctology Society. Ambulatory proctologic surgery: Recommendations of the French National Coloproctology Society (SNFCP). J Visc Surg. 2015 Dec;152(6):369-72. doi: 10.1016/j.jviscsurg.2015.10.001. Epub 2015 Nov 5.

ReferenceCitation: Joshi GP, Neugebauer EA; PROSPECT Collaboration. Evidence-based management of pain after haemorrhoidectomy surgery. Br J Surg. 2010 Aug;97(8):1155-68. doi: 10.1002/bjs.7161. Review.

ReferenceCitation: Sammour T, Barazanchi AW, Hill AG; PROSPECT group (Collaborators). Evidence-Based Management of Pain After Excisional Haemorrhoidectomy Surgery: A PROSPECT Review Update. World J Surg. 2017 Feb;41(2):603-614. doi: 10.1007/s00268-016-3737-1. Review.

lead_sponsor: Groupe Hospitalier Paris Saint Joseph


title: Discovery of Microbiome-based Biomarkers for Patients With Cancer Using Metagenomic

acronym: ONCOBIOTICS

summary: Multicentric prospective study with collection of biological samples as part of type II research

lead_sponsor: Gustave Roussy, Cancer Campus, Grand Paris


title: Physical Activity of Staff on Medical Duty in a Department of Anesthesia and Critical Care During Guards

acronym: AMAC

summary:
On-call work is an integral part of senior and junior patricians in a critical care department.

Several studies have examined the effect of sleep deprivation on physicians on call and the impact of sleep deprivation on the quality of patient care.

Some of these studies have shown that practitioners' concentration capacities have deteriorated as the guard progresses.

However, few studies have looked at the physical activity of practitioners over a period of on-call time (distance covered, number of steps,...), as well as other parameters than the time spent in communication over the telephone.

The age and seniority of practitioners seem to be factors that can influence these different parameters, and there are few figures in the literature.

lead_sponsor: CHU de Reims


title: NeuroCognitive Bases of Tool Use

acronym: TECHNITION

summary: Tool use is considered to be the hallmark of complex cognitive adaptations that humans have achieved trough evolution, that provides an adaptive advantage to the human species. Even if nonhuman species do use tools too, human tool use is much more complex and sophisticated. If humans have special abilities for tool use, it has to be grounded in a specific neuroanatomical substrate. Humans and nonhumans share a similar prehension system located within the superior parietal lobe and the intraparietal sulcus. However, there is a human specificity: the supramarginal gyrus within the left inferior parietal lobe is unique to humans, and could play a central role in tool use. This project aims to study the neurocognitive bases of human tool use with functional Magnetic Resonance Imaging (fMRI), to precise the cognitive mechanisms through which humans are able to use tools.


title: Uterine Rupture During Labor Among Women With a Prior Cesarean Delivery : Risks Factors, Maternal and Perinatal Outcomes

summary:
Although a rare event, uterine rupture during labour is one of the most serious obstetric complications because of the dramatic maternal-fetal consequences that can result.

Identifying the risk factors associated with uterine rupture would enable gynecologists to provide patients with risks of uterine rupture in the event of attempted vaginal delivery.

The aim of our study is to determine risks factors for uterine rupture during labour in patients with a previous cesarean delivery who have not given birth since and to assess the occurrence of maternal-fetal comply-cations compared to patients with a previous cesarean delivery without uterine rupture.


title: NoL Monitor Performances of Nociceptive and Non-nociceptive Stimuli Discrimination During Robotic Surgery Under Propofol-remifentanil Anaesthesia

acronym: ROBOTNOL

summary:
Anesthesia quality and safety have improved over the past decades, thanks to improved monitoring devices. No nociception monitoring is currently part of the standard of care. Usually, hemodynamic parameters are used to evaluate nociception (heart rate, HR, and mean arterial pressure, MAP), but none of them are specific. However, nociception evaluation is critical. Indeed, where excess of nociception can lead to arterial hypotension and respiratory depression, insufficient nociception can lead to acute postoperative pain, which is followed by persistent chronic pain in 10-50% of patients. Different monitoring devices have been developed but none of them are still used in current practice. Recently developed, the nociception level (NoL) index (MEDASENSE BIOMETRICS Ltd®, Ramat Gan, Israel) is an index of nociception, based on a nonlinear algorithm combination of heart rate, heart rate variability, photoplethysmograph wave amplitude, skin conductance, skin conductance fluctuations, and their time derivatives.

Robotic surgeries have started to spread over the world 20 years ago, claiming to be mini-invasive with less hemorrhage complications, with better success based on the technical advantages of the robot allowing better access during anatomical challenges procedures. Robotic surgery has been suggested to decrease pain during surgery and post-operatively, because of the decreases abdominal wall constraints induced by the robotic arms compared to the surgeon arms.

This observational prospective non-interventional monocentric study intend to evaluate the performance of the NoL index to discriminate protocol-defined nociceptive from non nociceptive stimuli during robotic surgery.

All patients, scheduled for a robotic surgery procedure, will be orally informed about the study during the anesthesia consultation. During the procedure, the anesthesia procedure will be the same for all patients, as part of the usual care in our department. The NoL monitor will be added for the purpose of this study, but the results will be hidden from all physicians. All settings will be left the physician in charge. At the end of the surgical procedure, before transfer to the recovery room, data for the monitor will be extracted on a dedicated universal serial bus (USB) key. Files will be safely stored under RedCap before analysis.


title: Clinical Benefits of TeleRehabilitation in Chronic Respiratory Failure Patients.

acronym: e-mouv

summary: It is widely described in the literature that exercise training improves patients' exercise tolerance, quality of life, symptoms, anxiety and depression, regardless of the location. Despite overwhelming evidence of the benefits of exercise training, only a very small percentage of eligible people have ever completed a program. Alternative modes of exercise training are needed to improve equity of access for patients with chronic respiratory disease. So TeleRehabilitation, using information and communication technologies to provide distance exercise training services, may be an answer.

lead_sponsor: SOS Oxygene Mediterranee

location_facility: Cabinet de pneumologie Clinique des Cèdres


title: Assessment in a Randomized Controlled Trial of Adverse Outcome in Asymptomatic Patients With Prior Coronary Revascularization Who Have a Systematic Stress Testing Strategy Or a Non-testing Strategy During Long-term Follow-up.

acronym: ARCACHON

summary:
Due to the lack of randomized controlled trials, the best follow-up strategy of asymptomatic patients after coronary artery revascularization is controversial. A systematic screening of silent myocardial ischemia may help prevent a major acute cardiac event. However, systematic screening strategy is costly and there is currently no evidence that repeated revascularization improve survival. Moreover, stress testing per se or additional procedures which can be performed with regard of stress testing results can cause unexpected complications.

ARCACHON is a national, multicenter, randomized, open label trial, that will evaluate the non-inferiority of a clinical follow-up as compared to a systematic stress testing strategy after coronary revascularization.


title: Objective Measurements of the Opacification of the Lens After Vitrectomy

acronym: MOCVIT

summary:
Cataract is the opacification of the lens. Usually cataract occurs slowly, causing progressive vision loss over several months or years.

In ophthalmic clinical practice, repeated objective quantitative measurements of lens opacity may be necessary to document its progression and support a surgical indication.

The subjective methods of evaluating the opacification of the lens have limitations, in particular due to the lack of reproducibility between observers. Thus, innovative objective techniques with precise and reproducible cataract classification results have been developed, such as the Objective Scatter Index (OSI) on the Optical Quality Analysis System (OQAS), Visiometrics SL in 2010 and, more recently, Average Lens Density (ALD) on the IOLMaster® 700 device. Cataract is diagnosed as mature when the OSI is ≥ 2 and / or when the ALD is ≥ 74 pixel units.

Vitrectomy is a surgery of the posterior segment of the eye indicated for retinal detachment, epimacular membranes, macular holes, vitreous hemorrhage. The incidence of post-vitrectomy cataract varies among studies, and the methodology is often retrospective. Age has already been identified as a risk factor for progression since in a study of 28 eyes of patients under 50 years old, only 7% developed cataracts secondarily, compared to 79% in the 'over 50' group.

To date, there is no prospective study describing the progression kinetics of lens opacification according to precise and reproducible quantitative objective criteria in patients treated by vitrectomy. It also involves confirming the age and preoperative lens status as a risk factor for postoperative cataract progression.

lead_sponsor: Fondation Ophtalmologique Adolphe de Rothschild


title: Evaluation of the Value of 18F-fluorodeoxyglucose Positron Emission Tomography (FDG PET) and Brain Perfusion Computed Tomography (CT Perfusion) for Predicting the Efficacy of Anti-angiogenic Therapy (Bevacizumab) in Patients With Recurrent Glioblastoma

acronym: EVA DOPA

summary: In this pilot study, the study evaluators will evaluate the ability of positron emission tomography (PET) with 18F-fluorodeoxyglucose (FDG PET) and the computed tomography (CT) perfusion scanner, individually and combined, to predict the effectiveness of anti-angiogenic treatment.

lead_sponsor: Centre Hospitalier Universitaire de Nīmes


title: Foley Catheter Versus Prostaglandin E2 (Propess) Inserts for Induction of Labor in Women With Term Premature Rupture Of Membranes : Mode of Delivery and Maternal and Fetal Outcomes

summary:
Premature rupture of membranes at term is a rupture that occurs at term (>37SA) before the start of labor. It complicates 5 to 10% of pregnancies and 6 to 22% of term pregnancies.

Althought some studies support efficacy of the Foley catheter for cervical ripening at term in induction of labor with intact membranes, it has not been well studied in women with premature rupture of membranes at term.

The aim of this retrospective study at the Montpellier University Hospital is to evaluate the effect of the Foley catheter compared to Propess in women with premature rupture of membranes at term, on the induction of labor and the maternal and fetal complications.


title: Impact of Pre-procedure Cognitive Status on Outcome at 3 Months After Transcatheter Aortic Valve Implantation

acronym: TAVI-Geriatrie

summary: This study plans to investigate the relationship between cognitive status pre-procedure, and clinical outcomes at 3 months in patients undergoing transcatheter aortic valve implantation (TAVI).


title: Risk of Recurrence of de Novo Mutations: Research and Quantification of Paternal Germinal Mosaicism by the Combined Use of Genomic Tools

acronym: RRMUT

summary:
Inclusion of 5 families Inclusions will be made by the clinical genetics department of the Rouen University Hospital (monocentric study) and will correspond to trios of parents + child with unexplained developmental abnormalities. The inclusion of patients will be integrated in routine care and will have as immediate benefit for the included families the extensive analysis of the proband and their parents' genomes by short and long read sequencing techniques, which represent the most comprehensive diagnostic tests for developmental diseases, and which are not currently routinely available. Inclusion in clinical genetics by clinicians accustomed to prescribing genome-wide analyses will allow clear and complete information to families. Collection of consents. The trio's DNA will already be available at the molecular genetics laboratory, and a new blood sample may be proposed if necessary. Collection of sperm from the father.
Identification of a large set of de novo mutations. Extraction of blood DNA and sending for sequencing of the complete genome to the National Centre for Research in Human Genomics (CNRGH, Evry), in the framework of a collaboration already initiated. Analysis of the sequencing data thanks to the already existing expertise in Rouen. Identification of about 40-120 de novo mutations per trio. At this stage: interpretation of the variations identified with the secondary objective of identifying the cause of the disease in children. Long read genomes will allow to phase the de novo variants to the paternal or to the maternal haplotype.
Search for de novo mutations in paternal sperm samples. Extraction of spermatic DNA. Design of a sequencing panel targeting the genetic variations identified in the different trios. Preparation of the libraries, targeted high throughput sequencing at great depth thanks to the techniques and equipment already operational. Specific search for the de novo variations identified in the probands (in 2.), with for each evaluation of (i) the presence of the variation in the sperm sample, (ii) the quantity of mosaicism, reflecting the proportion of carrier spermatozoa and therefore the risk of recurrence, (iii) the presence of my variation in the blood sample of both parents in deep sequencing.

lead_sponsor: University Hospital, Rouen

intervention_type: Genetic


title: Validity of the French Version of Deafness Questionnaires for Children and Adolescents

acronym: SSQ-PEACH

summary:
The care of deafness in children is difficult and the relevance of interventions is difficult to evaluate based on audiometric measurements alone.

Generic pediatric quality of life tools have been validated and used, among other things, to assess the quality of life of children with deafness. However, these non-specific tools do not make it possible to precisely target which factors and interventions are the most important for the quality of life in this population.

Achieving a score to monitor the quality of life objectively over time is fundamental to verify the effectiveness of interventions, and assess the impact on the child. There is currently no validated test in French for any of these uses and populations.

The objective of the study is to adapt the questionnaires "PEACH", "SSQ child (SSQ-C)" and "SSQ parents (SSQ-P)" to the French child, and statistically measure their internal and external validity by comparing them to a control group.

The validation of these three tests (PEACH, SSQ-P, SSQ-C) would make it possible to assess the hearing performance and quality of life of almost the entire pediatric population, for use in both clinical and academic practice.

lead_sponsor: Assistance Publique - Hôpitaux de Paris


title: Self-administered Hyperinsufflation Chest Mobilization Randomized Study on the Risk of Low Respiratory Infection in Patients With Multiple Sclerosis With Sputum Capacity Deficit

acronym: MS-COUGH

summary:
In patients with neuromuscular disease, chest mobilization by hyperinsufflation slows respiratory decline by almost 80% compared to controls, and prevents complications like pneumonia, atelectasis and respiratory distress.

This insufflation technique improves the airway clearance and reduces the need for invasive ventilation. It also improves CV and DEPtoux in patients with neuromuscular pathology


title: Physiopathology and Sequelae of COVID-19 Infection

acronym: SEQ-COV-PHYSIO

summary:
The data obtained from Covid-19 infections seem to suggest that the immunogenesis of Covid-19 could in some cases be the result of immune dysregulation. On the other hand, endocrine damage is possible at the tile of Covid-19 infection (mainly thyroid,adrenal, and hypothalamus). These disorders are autoimmune or linked to degeneration.

The main objective is to assess the thyroid function (thyrotropic axis) as well as the corticotropic adrenal function of patients who have had Copvid-19 pneumonia. The secondary objectives is to describe the pathophysiological mechanisms of pulmonary and vasculothrombotic involvement of Covid-19

lead_sponsor: Centre Hospitalier Universitaire, Amiens

intervention_type: Biological


title: Kinetics of COVID-19-neutralising Antibodies in Patients Residing in EHPAD / USLD: Influence of Immunosenescence

acronym: SERO-CoV-OLD

summary:
This study aims to determine how long COVID-19 neutralizing antibodies can be detected in an elderly institutionalized population presenting fragility factors.

This study also aims to stratify seroconversion by immunological profiles of the elderly patients residing in the EHPAD. This stratification requires the measurement of immunological marker levels already described in immunosenescence and also involved in the development of certain chronic infectious diseases more common in the elderly population. This analysis will enable the investigators to describe an immunological, clinical and biological profile representing a patient who has developed an immunity against COVID 19. It will also help the investigators to understand the different mechanisms leading to a reduced immune response after a potential administration of a vaccine. Finally, it will help describe the immune profiles of elderly residents who presented with non-severe forms of COVID-19.


title: Approche représentationnelle de l'Hippocampe Dans la Cognition : Étude en IRMf

acronym: SHIP

summary: Although traditional neuropsychological models associate medial temporal lobe (MTL) regions to memory, and the hippocampus to episodic memory, there is growing evidence supporting an alternative view. The representational view of the MTL proposes that such regions depends on the representations processed rather than the cognitive processes. The aim of this project is to characterise the role played by MTL areas, and particularly the hippocampus, in mnemonic and non-mnemonic cognition. Hypotheses stemming from the representational view will thus be tested, using functional MRI among young healthy participants.

lead_sponsor: University Hospital, Grenoble


title: Prospective Study of Immune Alterations in Operable Breast and Ovarian Carcinoma

acronym: GYNECO-IMM&CO

summary: GYNECO-IMM&Co is a prospective clinical and biological cohort ; this study aims to identify immune surveillance and escape mechanisms and also predictive biomarkers for survival patients who suffer from ovarian and breast carcinoma.

lead_sponsor: Centre Leon Berard


title: Development of a Virtual Reality Application for the Diagnosis of Childhood ADHD: an Exploratory Study

summary: The aim of this study is to develop an application in order to identify the most relevant cognitive and behavioral parameters for the diagnosis of Attention Deficit Hyperactivity Disorder (ADHD) in conditions closer to reality


title: Emotional Proactive Processing in Bipolar Disorder

summary: The main objective of this project is to identify behavioral specificities of the proactive emotional brain among bipolar patients, compared to healthy subjects. These could contribute to some of the emotional processing biases that can be observed in these patients. To achieve this goal, two behavioral tasks will be administer (emotional stroop and emotional stimuli categorization task) to bipolar patients and control subjects, and their performances will be compared.

ReferenceCitation: Beffara B, Wicker B, Vermeulen N, Ouellet M, Bret A, Molina MJ, Mermillod M. Reduction of interference effect by low spatial frequency information priming in an emotional Stroop task. J Vis. 2015;15(6):16. doi: 10.1167/15.6.16.

ReferenceCitation: Golden, C. (1978). Diagnosis and Rehabilitation in Clinical Neuropsychology. College of Psychology: Faculty Books and Book Chapters. https://nsuworks.nova.edu/cps_facbooks/48

ipd_sharing_description: If the patient accepts all the characteristics useful for the study will be available in our results.


title: Exploratory Study Evaluating the Relevance of [68Ga]Ga -PentixaFor for Initial Staging and Therapeutic Evaluation of Symptomatic Multiple Myeloma Patients in First Line Treatment

acronym: PentiMyelo

summary: The aim of our study is to confirm the relevance of PET using [68Ga]Ga -PentixaFor ligand, in comparison with FDG, for initial staging and therapeutic evaluation of symptomatic multiple myeloma patients in first line treatment. The prognostic value of positive CXCR4 expression will also be assessed and [68Ga]Ga -PentixaFor/FDG discordances explored.

intervention_type: Drug


title: Cohort Study on Sleep Architecture and Regulation, Cognitive Performance and Metabolism in Children With Narcolepsy

acronym: COSACM

summary: Narcolepsy is a rare disease that affects 0.05% of the general population. It is characterized by a dysregulation of the sleep wake regulation that leads to uncontrolled sleep episode during day and a disorganized sleep during night. These symptoms are due to a loss of hypocretin neurons in the brain leading to an inability to maintain wake properly. The physiopathology of this rare disease still needs investigations. Since we are a reference center for this disease, we propose to use patients files to better describe and document the sleep characteristics of these children, the cognitive performances, the effects of narcolepsy treatments on sleep architecture and the metabolic status of these children.

lead_sponsor: Hospices Civils de Lyon

location_facility: : Sleep pediatric unit , Woman Mother Child Hospital, Hospices Civils de Lyon


title: Feasability of Foot Reflexology to Alleviate Anxiety in Palliative Care Unit : a Pilot Randomised Double Blind Study

acronym: RPASP

summary: The primary purpose of the study is to know if foot reflexology can be accepted by patients hospitalized in palliative unit care (assessed by the number of patient who accept to participate), and if it is feasible (assessed by the realization of one session in normal condition : duration of 15-20 min, in supine position/seated or half-seated position).The investigators make the hypothesis that patients will accept to receive foot reflexology, and maybe feel less anxious after one session.

lead_sponsor: University Hospital, Clermont-Ferrand


title: Identifying Functional and Psycho-social Complaints After Hospitalization for Severe SARS-CoV-2 Infection (COVID19)- REPERCOV

acronym: REPERCOV

summary:
Since December 2019, China and then the rest of the world have been affected by the rapid spread of a new coronavirus infection called SARS-CoV-2 (severe acute respiratory syndrome coronavirus), the clinical expression of which is called Covid-19 (Coronavirus Disease 2019).

It is estimated that around 20% of symptomatic patients will be severe enough to warrant hospitalization, of which around 5% will be in intensive care.

Organ damage is multiple in Covid infection: respiratory, digestive, renal, neurological, cardiovascular due to the infection or its care. There is also a psychological and social impact of the infection or of the care that should be measured.

In this context, investigator will assess the physical and psychological complaints of patients who have presented a severe form of SARS-CoV-2 infection.

The final objective being to identify the needs to offer follow-up adapted to this emerging pathology.

lead_sponsor: Centre Hospitalier le Mans


title: Additive Value of Physiology Coronary in Clinical Practice

acronym: PRINCIPE

summary:
The important evidence of coronary microcirculation for the management of patients with coronary artery disease is only increasing. Thus, in recent years, a number of studies have shown that the demonstration of coronary microvascular disease (CMVD) contributes to cardiovascular morbidity and mortality increases independently of epicardial damage. This has been shown in stable coronary artery disease with screening for CMVD when there is no significant epicardial involvement and allowing the implementation of an adapted treatment then reducing the symptoms and improving the quality of life of our patients. (1). The prognostic nature of CMVD has also been identified in stable disease after coronary angioplasty (2) but also in patients with infarcts reperfused by coronary angioplasty (3).

The complete exploration of the epicardial and microvascular coronary vascularization is grouped under the name of the subspecialty: coronary physiology. Thus, an internationally recognized algorithm for exploring coronary physiology has been published (4).

However, this algorithm is still little followed. The PRINCIPE registry aims to assess the prevalence of CMVD with the use of a standardized algorithm for exploring coronary physiology by coronary angiography in our center in current practice.


title: Elucidating the Symptomatic, Explanatory and Prognostic Characteristics of GERIAtric Patients Hospitalized for COVID-19

acronym: GERIA-COVID

summary:
Statement :

The emerging Coronavirus 2019 (COVID-19) disease, linked to the SARS-CoV-2 (severe acute respiratory syndrome coronavirus 2) pathogen, has been spreading worldwide since December 2019, affecting millions of people and causing hundreds of thousands of deaths, particularly among the elderly.
The first epidemiological evidence available reveals a different expression of the disease in the elderly, associated with a high risk of delayed diagnosis and implementation of protective measures and a particularly high morbidity and mortality, especially among the frailest.
To date, there is no effective model for predicting the severity of COVID-19 in an individual.

The investigators hypothesize that there are specificities of COVID-19 in the elderly, both etiological, diagnostic and prognostic, all of which are not yet known and understood.

time_perspective: Other

lead_sponsor: University Hospital, Angers


title: Effect of Inhaled Aromatherapy on Chemo-Induced Nausea Vomiting (NCVI): CINVAROM (Chemotherapy Induced Nausea Vomiting and AROMatherapy)

acronym: CINVAROM

summary:
The investigator wish to provide a blend of two essential oils with comparable antiemetic properties; Peppermint essential oil (Mentha x Piperita) and lemon tree essential oil (Citrus Limon). Dry inhalation of these essential oils is safe, but effectiveness has not been determined. Studies on the subject present a questionable methodology. This is why we are proposing this study to measure the effectiveness of this mixture of essential oils on chemo-induced nausea and vomiting.

This study is a first step before a possible study to compare the effects of essential oils with those of a placebo.

lead_sponsor: Centre Francois Baclesse


title: Anxious School Refusal in Adolescents: Efficiency of a Cognitive and Behavioral Therapy (CBT) Day Hospital Program

acronym: RSA-Coll

summary: Anxious school refusal (ASR) is a common disorder which concerns more and more adolescents who are at worse completely absent from school. A specific ambulatory cognitive and behavioral therapy (CBT) program has been established to gradually reintegrate the child back into the school environment with a multidisciplinary team. Alongside school reintegration assessment, the child's overall ability to function and anxiety levels will be measured before and after the program with additional assessments made after a further 6 and 12 months have elapsed.

lead_sponsor: University Hospital, Montpellier


title: Micro-sleep During Maintenance Wakefulness Tests

summary: During general anesthesia, intraoperative hypotension (IOH) is associated with increased morbidity and mortality. Mean arterial pressure (MAP) < 65mmHg is the most common definition of hypotension. In order to reduce IOH, a complex method using machine learning called hypotensive prediction index (HPI) was shown to be superior to changes in MAP (ΔMAP) to predict hypotension (MAP between 65 and 75 excluded). Linear extrapolation of MAP (LepMAP) is also very simple and could be a better approach than ΔMAP. The main objective of the present study was to investigate whether LepMAP could predict IOH during anesthesia 1, 2 or 5 minutes before.


title: Impact of Intraoperative Fluid Challenges Administration on Macro and Microcirculation in Patients Undergoing High-risk Abdominal Surgery and Situated in the Gray Zone of Pulse Pressure Variation

acronym: FC

summary: The goal of this prospective observational study is to assess the impact of fluid challenge administration on macro and microcirculation in patients situated in the gray zone during a high risk abdominal surgery

status: Terminated

lead_sponsor: Erasme University Hospital


title: Comparisons of gaIt aNalyses pERformance Between the Gaitrite walkwaYs

acronym: CINERGY

summary:
The GAITRite® system is an instrumented with resistive pressure sensors gait analyzer. It was first validate in 2001 against paper-and-pencil (intraclass correlation coefficient [ICC] > 95%) for spatial measures and against video-based (ICC > 93%) for temporal measures, and was thus a reliable tools to measure step lengths and times in both walkway center and left-of-center measurements. It was considered as one of the gold standards in gait analyses. This gait analyze system may distinguish prospectively faller and non-faller older adults, but it can detect spatial, temporal, and spatiotemporal measures of gait and greater variability of gait parameters which were associated with and predictive of both global- and domain-specific cognitive decline. Moreover, spatiotemporal gait parameters analyzed using GAITRite® were more disturbed in the advanced stages of dementia, and more affected in the non-AD dementia than in AD suggesting that quantitative gait parameters could be used as a surrogate marker for improving the diagnosis of dementia.

Nevertheless, GAITRite® is not a unique system and it comprises different walkways. One of these technologies was a roll-up system (platinum plus classic, RE, Basic and Safari), and the other was a system composed by a changeable association of plates (CIRFACE). In order to ensure a good comparability between studies using these different walkways, it appears important to compare the performances of these walkways in gait analysis. Thus, the main aim of this study was to compare the performances in gait analyze between the GAITRite® platinum plus classic and the GAITRite® CIRFACE among older adults. Secondary aims were to compare these parameters among patients with cognitive complaint, minor or major neurocognitive disorder (NCD) related to Alzheimer disease.


title: Evaluation of the Experience of Lock Down Related to the Covid-19 Epidemic and Its Impact on the Project of Parenthood of the Couples Followed in Assisted Reproduction

acronym: CONFIN-AMP

summary: Observational, descriptive, cross-sectional, monocentric study, This Study is proposed to all couples followed in Assisted Reproduction and CECOS Nord for whom the protocols were stopped when they entered into confinement related to the Covid-19 epidemic on 13 March 2020.

lead_sponsor: University Hospital, Lille


title: Use of Extracorporeal CO2 Removal in Case of Moderate to Severe Acute Respiratory Distress Syndrome to Apply an Ultraprotective Mechanical Ventilation Strategy

summary: The extracorporeal CO2 removal (ECCO2R) has been recently proposed in case of Acute Respiratory Distress Syndrome (ARDS) in order to reduce pulmonary injuries induced by the mechanical ventilation. A reducing of tidal volume and/or respiratory rate is thus expected using this extracorporeal respiratory support. However, most of existing devices of ECCO2R can apply only a limited extracorporeal flow, often less than 1L/min, which limits the CO2 exchanges and does not allow to reach an ultraprotective ventilation. An extracorporeal flow higher should logically maximalize CO2 removal and allow reducing intensity of mechanical ventilation. Works focused on high-flow ECCO2R (2-3 L/min) in setting of ARDS are therefore mandatory to better understand apprehend the phenomena of gazes changes with this device and confirm the added-value in management of these specific patients.

ipd_sharing_description: identified data used in the published manuscript will be shared in accordance with the applicable informed consent under which the data was collected


title: Functional Recovery From Acute Respiratory Distress Syndrome (ARDS) Due to COVID-19: Influence of Socio-Economic Status

acronym: RECOVIDS

summary: In this study, the investigators are attempting to evaluate the influence of socio-economic factors on the functional recovery (physical and psychological) of patients who developed ARDS after a COVID-19 infection, with the aim of offering personalized medical and social follow-up and support measures in order to avoid medium- and long-term complications, which can result in handicaps, reduced quality of life, and a higher risk of death.

ReferenceCitation: Declercq PL, Fournel I, Demeyere M, Ksiazek E, Meunier-Beillard N, Rivière A, Clarot C, Maizel J, Schnell D, Plantefeve G, Ampere A, Daubin C, Sauneuf B, Kalfon P, Federici L, Redureau É, Bousta M, Lagache L, Vanderlinden T, Nseir S, La Combe B, Bourdin G, Monchi M, Nyunga M, Ramakers M, Oulehri W, Georges H, Salmon Gandonniere C, Badie J, Delbove A, Monnet X, Beduneau G, Artaud-Macari É, Abraham P, Delberghe N, Le Bouar G, Miailhe AF, Hraiech S, Bironneau V, Sedillot N, Hoppe MA, Barbar SD, Calcaianu GD, Dellamonica J, Terzi N, Delpierre C, Gélinotte S, Rigaud JP, Labruyère M, Georges M, Binquet C, Quenot JP; RECOVIDS trial investigators. Influence of socioeconomic status on functional recovery after ARDS caused by SARS-CoV-2: a multicentre, observational study. BMJ Open. 2022 Apr 22;12(4):e057368. doi: 10.1136/bmjopen-2021-057368.

lead_sponsor: Centre Hospitalier Universitaire Dijon


title: Effectiveness of an Educational Intervention Aimed at Increasing the Emotional Competencies of Patients Under Surveillance After Antineoplastic Treatment of Oesogastric or Bronchopulmonary Cancer: a Randomized, Multicenter, Controlled Pilot Study (EmoVie-K2)

summary: Emotional skills are the ability to use emotions cleverly in daily life. Good emotional skills are associated with better mental and physical health in healthy and clinical populations. However, to our knowledge, cancer patients have never benefited from an intervention aiming at increasing their emotional skills. Our goal was thus to design and test such an intervention. A prospective, multi-center, randomized controlled trial (RCT) will be conducted in esogastric and lung cancer patients after antineoplastic treatments. Forty-three patients are expected in each arm. The primary outcome is the change in emotional skills assessed using a patient-reported validated questionnaire between the start and two weeks after the end of the intervention and at 2-month follow-up. The experimental arm will have to follow three individual sessions on emotional skills (i.e. identification, understanding, expression and regulation of emotions) while the control arm will have to follow three sessions of relaxation. In each arm, the first session can be held face to face or over the phone and the last two sessions will be held over the phone. Patients have exercises to practice in between sessions.It is hypothesised that the experimental group will experience a greater increase in emotional skills than the control group.


title: Impact of Web Application Support Versus Standard Management on Compliance With Adjuvant Hormone Therapy at 18 Months in Patients Treated for Breast Cancer

acronym: WEBAPPAC

summary: The investigators hypothesize that the implementation of a Web-application in patients initiating adjuvant hormone therapy for breast cancer brings a benefit on treatment adherence and quality of life.


title: Complicated Grief in ICU in the Aftermath of COVID-19

acronym: DEPARTS

summary:
An increased proportion of deaths occur in the intensive care unit (ICU). Some amenable factors such as end-of-life practices may contribute to complicated grief.

Because of the COVID-19 pandemic, visitor restrictions in health care facilities have been implemented. Families were also unable to implement usual funerals. The investigators hypothesize that these policies and practices may impact grief during covid-19 pandemic. The aim of this study is to evaluate the prevalence of complicated grief after death of a relative in the ICU during the COVID-19 pandemic.


title: An Appraisal of Minimal Invasive Surgery for Thoracic Child Neurogenic Tumour. A Multicentric Study

acronym: DIUOP

summary:
Mediastinal neurogenic tumors are relatively rare in children. Surgical resection is essential. Minimal invasive surgery is more and more used in pediatric population, but his evaluation for resection of thoracic neurogenic tumors is little studied.

Thoracotomy has specific long terms post operative complications. When compared to thoracotomy, thoracoscopy shows less operative blood loss, shorter duration of chest tube ans length of stay.

Recently, the indications of thoracoscopic approach have been assessed according to the presence or absence of image-defined risk factors (IDRF) at diagnosis and after preoperative chemotherapy in a monocentric retrospective study.

The investigators aimed to conduct a multicentric retrospective study to assess the role of thoracoscopy in neurogenic thoracic tumours according to the presence or absence of IDRF at diagnosis, the surgical complications and outcome.

lead_sponsor: Fondation Lenval


title: Follow-up CoViD-19 Patients Hospitalized in Reims University Hospital Between the 01/03/2020 and 30/04/2020

acronym: COVID-Reims

summary:
Medical context: Follow-up of a retrospective cohort of 499 cases of CoViD-19, hospitalized at the University Hospital of Reims during the health crisis, prospectively up to two years of follow-up.

Possible intervention for serological monitoring, leading to a change from category 3 to category 2 (French law on human person research)

Aim of the study: To know the factors of gravity of CoViD-19, to know its prognostic factors, to see how the evolution of the treatments implemented have influenced the fate of the patients.

Material and methods:

Type of study: cohort study Population: Patients in the CoViD-19 cohort - Reims Calendar: September 2020 - July 2022

Expected results: Better knowledge of the cares of patients with CoViD-19

lead_sponsor: CHU de Reims


title: Collection of Clinical and Biometrological Data in Adult Subjects Suffering From Atopic Dermatitis (AD) During a Three-month Period

summary:
Atopic dermatitis represents a real challenge in public health as it affects a large percentage of children and adults. Affected individuals must cope with a significant psychosocial burden, in addition to dealing with the medical aspects of the disease.

The purpose of this exploratory study is to collect clinical severity AD data, using PO-SCORAD (self-assessment by the subjects), SCORAD evolution, instrumental measurements and treatment follow up of subjects.

The future objective is to develop a personalised prediction model of AD flares in order to improve management of AD by more accurate severity evaluations by the subject and the physician. Development of a method of early detection of flares will open new treatment pathways for AD management.

lead_sponsor: Pierre Fabre Dermo Cosmetique


title: Evaluation of the Effects of Personalized Training at Home Combining Endurance and Resistance in Patients Suffering From Marfan Syndrome

acronym: MARF'HOME

summary:
Marfan syndrome (MS) is an autosomal dominant genetic disorder caused by a mutation in the fibrillin-1 gene (FBN1) encoding the protein fibrillin-1. Fibrillin is the main component of microfibrils, elements found in all of the body's tissues, and this pathology is characterized by the multitude of its clinical manifestations. These patients may develop aneurysms in the aortic root and one of the main factors of morbidity in patients with MS is aortic dissection. Prevention mainly involves preventive aortic surgery. However, the repercussions are global and can affect the functioning of other tissues such as skeletal muscle tissue, bone tissue, lung tissue and the eyes. The association of skeletal (scoliosis, hyperlaxity), muscular and ocular disorders is clearly associated with an impairment in the quality of life. These disorders are associated with pain and disability which affect professional activity, leisure and family life.

Physical activity could represent a relevant alternative for these patients. A recent animal study suggests that moderate training is beneficial.

lead_sponsor: French Cardiology Society

location_facility: Groupe Hospitalier Bichat - Claude Bernard


title: Assessment of the Impact of an add-on and Its Smartphone Application on the Daily Management of Glaucoma

acronym: CONDORE

summary:
Glaucoma is one of the most common chronic pathologies and affects several millions patients. Among these, many have a poorly controlled glaucoma, damaging vision and leading to blindness.

One between principal reasons for poor glaucoma medication adherence is forgetfulness. To improve this issue, digital tools may benefit both ophthalmologists and patients by monitoring eye drop administration.

lead_sponsor: Laboratoires Thea


title: Urea Therapy for Hyponatremia in Subarachnoid Hemorrhage

acronym: NAT-URE

summary: Hyponatremia is defined as a plasma sodium concentration below 135 mmol / L. This is a common occurrence (20-50%) during subarachnoid hemorrhage (SAH). Its appearance is often associated with vasospasm. It is associated with an increase in morbidity and mortality linked to induced neurological disorders. Hyponatremia is caused by two etiologies: the syndrome of inappropriate secretion of anti-diuretic hormone (SIADH), and the cerebral salt wasting syndrome, CSWS. Theoretically, these two entities are differentiated by the patient's volemia; in practice, this parameter is difficult to measure. In addition, the correction of hyponatremia is diametrically opposed according to its mechanism: water restriction in the case of SIADH, sodium intake in the event of CSWS. Urea is offered as a second-line treatment in the event of treatment failure to correct hyponatremia. However, the efficacy of this treatment is based on small, observational, retrospective studies. Moreover, the mechanism of action of urea remains poorly understood: it could be a hyperosmolar effect or passive renal reabsorption of sodium.

ReferenceCitation: Hall A, O'Kane R. The Extracranial Consequences of Subarachnoid Hemorrhage. World Neurosurg. 2018 Jan;109:381-392. doi: 10.1016/j.wneu.2017.10.016. Epub 2017 Oct 16. Review.

ReferenceCitation: Mapa B, Taylor BE, Appelboom G, Bruce EM, Claassen J, Connolly ES Jr. Impact of Hyponatremia on Morbidity, Mortality, and Complications After Aneurysmal Subarachnoid Hemorrhage: A Systematic Review. World Neurosurg. 2016 Jan;85:305-14. doi: 10.1016/j.wneu.2015.08.054. Epub 2015 Sep 7. Review.

ReferenceCitation: Hannon MJ, Behan LA, O'Brien MM, Tormey W, Ball SG, Javadpour M, Sherlock M, Thompson CJ. Hyponatremia following mild/moderate subarachnoid hemorrhage is due to SIAD and glucocorticoid deficiency and not cerebral salt wasting. J Clin Endocrinol Metab. 2014 Jan;99(1):291-8. doi: 10.1210/jc.2013-3032. Epub 2013 Dec 20. Erratum in: J Clin Endocrinol Metab. 2014 Mar;99(3):1096. Javadpur, M [corrected to Javadpour, M].

ReferenceCitation: Nakajima H, Okada H, Hirose K, Murakami T, Shiotsu Y, Kadono M, Inoue M, Hasegawa G. Cerebral Salt-wasting Syndrome and Inappropriate Antidiuretic Hormone Syndrome after Subarachnoid Hemorrhaging. Intern Med. 2017;56(6):677-680. doi: 10.2169/internalmedicine.56.6843. Epub 2017 Mar 17.

ReferenceCitation: Hoorn EJ, Zietse R. Diagnosis and Treatment of Hyponatremia: Compilation of the Guidelines. J Am Soc Nephrol. 2017 May;28(5):1340-1349. doi: 10.1681/ASN.2016101139. Epub 2017 Feb 7. Review.


title: Evaluation of Age-related Skin Changes and Instrument Reliability Using Clinical Probe Measurements and Imaging Modalities

summary: To evaluate the reliability of different non-invasive skin probe measurements.

ipd_sharing_description: Allergan will share de-identified patient-level data and study-level data including protocols and clinical study reports for phase 2 - 4 trials completed after 2008 that are registered to ClinicalTrials.gov or EudraCT, have received regulatory approval in the United States and/or the European Union in a given indication and the primary manuscript from the trial has been published. To request access to the data, the researcher must sign a data use agreement and any shared data is to be used for non-commercial purposes. More information can be found on http://www.allerganclinicaltrials.com/.

lead_sponsor: Allergan


title: Comparative Study of the PRAEVAorta Device in Patients With an Abdominal Aortic Aneurysm (AAA) : Percentage of Adequacy to the Gold Standard

summary:
Nurea wants to set-up a pivotal phase clinical study for its software PRAEVAorta, a decision-making support for diagnosis and follow-up of abdominal aorta aneurysm. This study is a comparative study. Its purpose is to demonstrate the adequacy of PRAEVAorta to the current Gold Standard in the care of patients with abdominal aortic aneurysm. The currently benchmark methods are the maximal diameter method (Hand-held measurement of maximum diameter on scan images) and the segmentation method for the aneurysm volume (manual segmentation of scan images, then calculation of the AAA volume by counting the pixels).

The hypothesis is that 90% of the segmented patients have a volume ratio and a diameter ration equal to or greater than 90%.

status: Suspended

ReferenceCitation: Schnitzbauer M, Güntner O, Wohlgemuth WA, Zeman F, Haimerl M, Stroszczynski C, Müller-Wille R. CT after Endovascular Repair of Abdominal Aortic Aneurysms: Diagnostic Accuracy of Diameter Measurements for the Detection of Aneurysm Sac Enlargement. J Vasc Interv Radiol. 2018 Feb;29(2):178-187.e3. doi: 10.1016/j.jvir.2017.09.012. Epub 2017 Dec 6.

ReferenceCitation: Kauffmann C, Tang A, Therasse E, Giroux MF, Elkouri S, Melanson P, Melanson B, Oliva VL, Soulez G. Measurements and detection of abdominal aortic aneurysm growth: Accuracy and reproducibility of a segmentation software. Eur J Radiol. 2012 Aug;81(8):1688-94. doi: 10.1016/j.ejrad.2011.04.044. Epub 2011 May 20.

ReferenceCitation: Lareyre F, Adam C, Carrier M, Dommerc C, Mialhe C, Raffort J. A fully automated pipeline for mining abdominal aortic aneurysm using image segmentation. Sci Rep. 2019 Sep 24;9(1):13750. doi: 10.1038/s41598-019-50251-8.

lead_sponsor: Nurea

location_facility: Hopital Universitaire Pellegrin Bordeaux


title: Nation-wide Health Resource Consumption and Costs Associated With Mepolizumab (Nucala): a French SNDS Database Study

acronym: Resala

summary:
Currently, no study has addressed real-life data describing changes in health resource consumption and related costs attributable to mepolizumab treatment. The aim of the current study is to fill this knowledge gap by performing an exhaustive extraction of data for patients receiving mepolizumab in the French single-payer health care system. The change in real-life health-resource usage and costs observed for these patients would provide the first evidence that mepolizumab is changing the care landscape for eligible severe asthma patients.

The overall objectives of this study are: (i) using the SNDS French national database, to identify a representative, nation-wide population of patients treated with mepolizumab with a follow-up period of at least 12 months, (ii) to describe the initial one-year changes in health resource use before and after the initiation of mepolizumab treatment and (iii) to estimate the change in associated costs for the first year of treatment. These initial data will additionally serve as a basis for the design of longer-term studies.

Primary objective: To estimate the change in associated costs for the first year of treatment

ipd_sharing_description: SNDS data are accessible only by specially trained and qualified individuals. Due to regulatory constraints, they cannot be made available to the public.


title: Bacterial Infections in People Who Inject Psychoactive Substances

summary: Bacterial infections in people who inject psychoactive substances


title: Interest of Coronary CT Scan Before Complex Chronic Total Occlusion (CTO) Percutaneous Coronary Intervention (PCI).

acronym: CTS-C-CTOPCI

summary: The chronic total occlusion of a coronary artery is the most frequent cardiac disease in the developped countries. The percutaneous coronary intervention is one of the existing treatments. This procedure is long, expensive and uses a lot of contrast medium and X ray. With this study, the investigators want to adress the impact of CT scan performed before the surgical procedure. A better knowledge of the patient's anatomy could lead to a better success rate of the operation, with a lower radiation, lower contrast injection, and a faster and more cost-efficient procedure.

ReferenceCitation: Chesebro JH, Knatterud G, Roberts R, Borer J, Cohen LS, Dalen J, Dodge HT, Francis CK, Hillis D, Ludbrook P, et al. Thrombolysis in Myocardial Infarction (TIMI) Trial, Phase I: A comparison between intravenous tissue plasminogen activator and intravenous streptokinase. Clinical findings through hospital discharge. Circulation. 1987 Jul;76(1):142-54.

ReferenceCitation: Fefer P, Knudtson ML, Cheema AN, Galbraith PD, Osherov AB, Yalonetsky S, Gannot S, Samuel M, Weisbrod M, Bierstone D, Sparkes JD, Wright GA, Strauss BH. Current perspectives on coronary chronic total occlusions: the Canadian Multicenter Chronic Total Occlusions Registry. J Am Coll Cardiol. 2012 Mar 13;59(11):991-7. doi: 10.1016/j.jacc.2011.12.007.

ReferenceCitation: Morino Y, Abe M, Morimoto T, Kimura T, Hayashi Y, Muramatsu T, Ochiai M, Noguchi Y, Kato K, Shibata Y, Hiasa Y, Doi O, Yamashita T, Hinohara T, Tanaka H, Mitsudo K; J-CTO Registry Investigators. Predicting successful guidewire crossing through chronic total occlusion of native coronary lesions within 30 minutes: the J-CTO (Multicenter CTO Registry in Japan) score as a difficulty grading and time assessment tool. JACC Cardiovasc Interv. 2011 Feb;4(2):213-21. doi: 10.1016/j.jcin.2010.09.024.

ReferenceCitation: Rolf A, Werner GS, Schuhbäck A, Rixe J, Möllmann H, Nef HM, Gundermann C, Liebetrau C, Krombach GA, Hamm CW, Achenbach S. Preprocedural coronary CT angiography significantly improves success rates of PCI for chronic total occlusion. Int J Cardiovasc Imaging. 2013 Dec;29(8):1819-27. doi: 10.1007/s10554-013-0258-y. Epub 2013 Jun 23.

ReferenceCitation: Yu CW, Lee HJ, Suh J, Lee NH, Park SM, Park TK, Yang JH, Song YB, Hahn JY, Choi SH, Gwon HC, Lee SH, Choe YH, Kim SM, Choi JH. Coronary Computed Tomography Angiography Predicts Guidewire Crossing and Success of Percutaneous Intervention for Chronic Total Occlusion: Korean Multicenter CTO CT Registry Score as a Tool for Assessing Difficulty in Chronic Total Occlusion Percutaneous Coronary Intervention. Circ Cardiovasc Imaging. 2017 Apr;10(4). pii: e005800. doi: 10.1161/CIRCIMAGING.116.005800.

ReferenceCitation: Singh S, Singh N, Gulati GS, Ramakrishnan S, Kumar G, Sharma S, Bahl VK. Dual-Source Computed Tomography for Chronic Total Occlusion of Coronary Arteries. Catheter Cardiovasc Interv. 2016 Oct;88(4):E117-E125. doi: 10.1002/ccd.25516. Epub 2014 May 27.

ReferenceCitation: Ghoshhajra BB, Takx RAP, Stone LL, Girard EE, Brilakis ES, Lombardi WL, Yeh RW, Jaffer FA. Real-time fusion of coronary CT angiography with x-ray fluoroscopy during chronic total occlusion PCI. Eur Radiol. 2017 Jun;27(6):2464-2473. doi: 10.1007/s00330-016-4599-5. Epub 2016 Sep 23.

ReferenceCitation: Li Y, Xu N, Zhang J, Li M, Lu Z, Wei M, Lu B, Zhang Y. Procedural success of CTO recanalization: Comparison of the J-CTO score determined by coronary CT angiography to invasive angiography. J Cardiovasc Comput Tomogr. 2015 Nov-Dec;9(6):578-84. doi: 10.1016/j.jcct.2015.07.005. Epub 2015 Jul 23.

ReferenceCitation: Opolski MP, Achenbach S. CT Angiography for Revascularization of CTO: Crossing the Borders of Diagnosis and Treatment. JACC Cardiovasc Imaging. 2015 Jul;8(7):846-58. doi: 10.1016/j.jcmg.2015.05.001. Review.

ReferenceCitation: Chen Y, Lu B, Hou ZH, Gao Y, Yu FF, Yin WH, Wang ZQ. Predicting successful percutaneous coronary intervention in patients with chronic total occlusion: the incremental value of a novel morphological parameter assessed by computed tomography. Int J Cardiovasc Imaging. 2015 Aug;31(6):1263-9. doi: 10.1007/s10554-015-0679-x. Epub 2015 May 17.

ReferenceCitation: Opolski MP, Achenbach S, Schuhbäck A, Rolf A, Möllmann H, Nef H, Rixe J, Renker M, Witkowski A, Kepka C, Walther C, Schlundt C, Debski A, Jakubczyk M, Hamm CW. Coronary computed tomographic prediction rule for time-efficient guidewire crossing through chronic total occlusion: insights from the CT-RECTOR multicenter registry (Computed Tomography Registry of Chronic Total Occlusion Revascularization). JACC Cardiovasc Interv. 2015 Feb;8(2):257-267. doi: 10.1016/j.jcin.2014.07.031.

ReferenceCitation: Takimura H, Muramatsu T, Tsukahara R. CT coronary angiography-guided percutaneous coronary intervention for chronic total occlusion combined with retrograde approach. J Invasive Cardiol. 2012 Jan;24(1):E5-9.

ReferenceCitation: Rodríguez-Granillo GA, Rosales MA, Llauradó C, Ivanc TB, Rodríguez AE. Guidance of percutaneous coronary interventions by multidetector row computed tomography coronary angiography. EuroIntervention. 2011 Jan;6(6):773-8. doi: 10.4244/EIJV6I6A131. Review.

ReferenceCitation: Tajti P, Karmpaliotis D, Alaswad K, Jaffer FA, Yeh RW, Patel M, Mahmud E, Choi JW, Burke MN, Doing AH, Dattilo P, Toma C, Smith AJC, Uretsky B, Holper E, Wyman RM, Kandzari DE, Garcia S, Krestyaninov O, Khelimskii D, Koutouzis M, Tsiafoutis I, Moses JW, Lembo NJ, Parikh M, Kirtane AJ, Ali ZA, Doshi D, Rangan BV, Ungi I, Banerjee S, Brilakis ES. The Hybrid Approach to Chronic Total Occlusion Percutaneous Coronary Intervention: Update From the PROGRESS CTO Registry. JACC Cardiovasc Interv. 2018 Jul 23;11(14):1325-1335. doi: 10.1016/j.jcin.2018.02.036. Epub 2018 Apr 26.

ReferenceCitation: Maeremans J, Walsh S, Knaapen P, Spratt JC, Avran A, Hanratty CG, Faurie B, Agostoni P, Bressollette E, Kayaert P, Bagnall AJ, Egred M, Smith D, Chase A, McEntegart MB, Smith WH, Harcombe A, Kelly P, Irving J, Smith EJ, Strange JW, Dens J. The Hybrid Algorithm for Treating Chronic Total Occlusions in Europe: The RECHARGE Registry. J Am Coll Cardiol. 2016 Nov 1;68(18):1958-1970. doi: 10.1016/j.jacc.2016.08.034.

ReferenceCitation: Hunt CH, Hartman RP, Hesley GK. Frequency and severity of adverse effects of iodinated and gadolinium contrast materials: retrospective review of 456,930 doses. AJR Am J Roentgenol. 2009 Oct;193(4):1124-7. doi: 10.2214/AJR.09.2520.

ReferenceCitation: McCullough PA, Wolyn R, Rocher LL, Levin RN, O'Neill WW. Acute renal failure after coronary intervention: incidence, risk factors, and relationship to mortality. Am J Med. 1997 Nov;103(5):368-75.

ReferenceCitation: Galassi AR, Sianos G, Werner GS, Escaned J, Tomasello SD, Boukhris M, Castaing M, Büttner JH, Bufe A, Kalnins A, Spratt JC, Garbo R, Hildick-Smith D, Elhadad S, Gagnor A, Lauer B, Bryniarski L, Christiansen EH, Thuesen L, Meyer-Geßner M, Goktekin O, Carlino M, Louvard Y, Lefèvre T, Lismanis A, Gelev VL, Serra A, Marzà F, Di Mario C, Reifart N; Euro CTO Club. Retrograde Recanalization of Chronic Total Occlusions in Europe: Procedural, In-Hospital, and Long-Term Outcomes From the Multicenter ERCTO Registry. J Am Coll Cardiol. 2015 Jun 9;65(22):2388-400. doi: 10.1016/j.jacc.2015.03.566.

ReferenceCitation: Patel VG, Brayton KM, Tamayo A, Mogabgab O, Michael TT, Lo N, Alomar M, Shorrock D, Cipher D, Abdullah S, Banerjee S, Brilakis ES. Angiographic success and procedural complications in patients undergoing percutaneous coronary chronic total occlusion interventions: a weighted meta-analysis of 18,061 patients from 65 studies. JACC Cardiovasc Interv. 2013 Feb;6(2):128-36. doi: 10.1016/j.jcin.2012.10.011. Epub 2013 Jan 23. Review.

ReferenceCitation: Hannan EL, Zhong Y, Jacobs AK, Stamato NJ, Berger PB, Walford G, Sharma S, Venditti FJ, King SB 3rd. Patients With Chronic Total Occlusions Undergoing Percutaneous Coronary Interventions: Characteristics, Success, and Outcomes. Circ Cardiovasc Interv. 2016 May;9(5):e003586. doi: 10.1161/CIRCINTERVENTIONS.116.003586.

ReferenceCitation: Brilakis ES, Banerjee S, Karmpaliotis D, Lombardi WL, Tsai TT, Shunk KA, Kennedy KF, Spertus JA, Holmes DR Jr, Grantham JA. Procedural outcomes of chronic total occlusion percutaneous coronary intervention: a report from the NCDR (National Cardiovascular Data Registry). JACC Cardiovasc Interv. 2015 Feb;8(2):245-253. doi: 10.1016/j.jcin.2014.08.014.

lead_sponsor: Elsan


title: Contribution of L-Tyrosine to Recovery From Operational Strain on Return From External Operation

acronym: USOP

summary:
Operational conditions amplify soldier's constraints and stress factors, upsetting individual and collective adaptive landmarks. The soldier's resistance is strained by the high intensity of stressors, by the long duration of exposure and by their cumulative effect.

This may lead to a state of "operational strain" that refers to chronic stress and the allostatic load imposed by operational constraint.

The investigators believe that operational strain could manifest itself by a kind of accelerated aging of the organism due to the increased allostatic load without sufficient resource restoration (neurotransmitter precursors, partial and repeated sleep deprivation, etc.).

This aging mechanism would be reversible after a sufficient period of resource restoration (sleep, physical activity, adapted diet, etc.).

lead_sponsor: Direction Centrale du Service de Santé des Armées

location_facility: Institut de Recherche Biomédicale des Armées


title: Prevalence Of COVID-19 Among Health-workers in a French General Hospital

acronym: POCAH-COVID

summary: The aim of this study is to evaluate the prevalence of COVID-19 among the workers of our hospital and the factors that are likely to influence this prevalence. It must be underlined that our hospital is settled in two towns and both hospital sites had different missions regarding the admissions of COVID-19-infected patients.

lead_sponsor: Centre Hospitalier Sud Essonne


title: Markers of Executive Attention Development in Preschoolers

acronym: MEDiATE

summary: This project aims to identify precursors of executive attention that can serve as early markers of ADD.

lead_sponsor: University Hospital, Caen


title: Simplification de l'évaluation de l'Activité PHysique Par Interrogatoire Rapide

acronym: SAPHIR

summary: The purpose of this study is to test and validate a new questionnaire (SAPHIR) in order to get an evaluation of patients physical activity.

lead_sponsor: University Hospital, Angers


title: Impact of the Training of Nursing Staff on the Practice of Manual Expression of Early Colostrum in Neonatal Medicine

acronym: ORLIKID

summary:
Colostrum is an irreplaceable nutrient rich in protein and antibodies. Its taste and smell are similar to those of amniotic fluid (therefore rich for the senses of the baby separated from his mother). It should be offered to every newborn baby, regardless of term and the type of breastfeeding their mom wants. The early expression of colostrum, within the first 2 hours after childbirth, is an essential way to start lactation of a mother separated from her baby. The sooner and more often the mother stimulates her breasts, the more milk she will have for her baby in the weeks to come. Manual expression of milk is therefore an essential gesture to initiate lactation, maintain it, and giving colostrum to babies as early as possible is beneficial. Two studies carried out in the neonatal medicine department of Felix Guyon Hospital in premature infants <33 week of amenorrhea (PRE'OLACT study in 2015-2016 by Dr RAJAOFERA and Diploma from university (DU) breastfeeding brief in 2018-2019 by Dr GRONDARD) found the same results: the desire for breastfeeding is 80% but manual expression of colostrum before H24 is only achieved by 30% of mothers and before H6 in only 6% of cases.

.

lead_sponsor: Centre Hospitalier Universitaire de la Réunion


title: Assessment of Emotional Memory During Transient Global Amnesia

acronym: EMOTICTUS

summary: There are few studies on the role played by emotions in transient global amnesia (TGA), in particular with regard to their impact on the functioning of memory. The study investigators wish to better understand the link between episodic memory, emotional state and psychogenic factors during TGA. It would be interesting to see if the patients suffering from TGA triggered by a psychological shock process emotional information differently from those whose TGA was triggered by an "organic" shock (physical effort, trauma, etc.). Finally, amnesic stroke is a good model for better understanding the function of the hippocampus, in particular of the CA1 region, in episodic memory.

lead_sponsor: Centre Hospitalier Universitaire de Nīmes


title: Hospitalisations of Teenagers and Young Adulthoods in Mayotte After Consumption of an Illegal Drug Called " Chimique ", Which Substances Are Incriminated ? : HOMACHI

acronym: HOMACHI

summary: The study aims (i) to identify which substances leading to hospitalizations at Mayotte are also called "chimique" and (ii) to correlate these substances with clinical pictures in order to favor a better approach of the treatments.

lead_sponsor: University Hospital, Bordeaux


title: Assessment of Efficacy of Hypnosis Intervention During Lavage Procedure for Knee Osteoarthrosis

acronym: HypnoArt

summary: The purpose of this study is to determine whether hypnosis intervention added to usual care is more effective than usual care alone to control pain during lavage procedure in patients with knee osteoarthrosis

lead_sponsor: Assistance Publique - Hôpitaux de Paris

location_facility: Cochin Hospital - Rheumatology department


title: Somesthesic Role of the Ventro-lateral Prefrontal Cortex in Speech Motor Learning fMRI Study

summary: These studies test the hypothesis that frontal areas of the brain participate in the cortical networks involved in the somotosensory processing that happens during speech motor learning.

lead_sponsor: University Hospital, Grenoble


title: Visio-consultation Compared to Face-to-face Consultation During the Follow-up of Apneic Patients Treated by Continuous Positive Airway Pressure (CPAP)

acronym: VISIOSAS

summary: Prospective multicenter open-label randomized clinical trial comparing videoconsultation to a face-to-face consultation during the follow-up of apneic patients treated by continuous positive pressure (CPAP) .


type: EudraCT Number

title: Monocentric Phase 1 Study With Escalation of Doses of Tocilizumab in Combination With Chemotherapy (Idarubicin and Cytarabine) in Patients With Acute Myeloblastic Leukemia (AML) With Poor Prognosis: TOCILAM"

acronym: Tocilam

summary: This is a phase 1 dose escalation study testing the addition of an anti-IL6 (tocilizumab) to standard induction chemotherapy for high-risk AML.

lead_sponsor: Nantes University Hospital