title: Impact of a Multidisciplinary Consultation Program on Drug Adherence in First Oral Anticancer Treatment

acronym: IMPAM

summary: Oncology management has changed dramatically over the last decade with the approval and rapid adoption of newly targeted oral oncology medications. The movement to oral oncology medications has altered the balance of risks and adverse effects (AEs) in the treatment of cancer care. These treatments are associated with a different constellation of AEs and drug interactions. Patients receiving treatment with oral anticancer treatment (OAT) encounter several barriers to adherence, which may include limited access to specialty medications, severe adverse effects, complex medication regimens, and special handling precautions. Medication nonadherence not only reduces the efficacy of drug therapy but also has the potential to increase healthcare expenditures due to disease-related hospitalizations. The purpose of this study is to evaluate the drug adherence in cancer patients, using the medication possession ratio (MPR), before and after the implementation of a multidisciplinary consultation program (MCP), on initiation of OAT.

lead_sponsor: Centre Hospitalier Universitaire, Amiens


title: Analytical Validation of the abioSCOPE Device With a PSP Test: Point-of-Care Precision, Sample Type Comparison and Sample Stability

summary:
Abionic SA has developed a novel point-of-care (POC) platform, the abioSCOPE, and an in vitro diagnostic kit for the quantification of the pancreatic stone protein (PSP) to be analyzed specifically with the abioSCOPE® device. This test is intended to be used to aid in the early recognition of sepsis. The test is extremely easy to use and has a total turnaround time of approximately 8 minutes. This test uses only 30 microliters of K2/K3-EDTA anticoagulated whole blood or plasma. Results are quantitative (ng/ml). The product is for Investigational Use Only in the US and bears CE-marking. It is commercially available in selected European and non-European countries. The test has also been clinically validated in a multicentric, prospective, observational study performed (AB-PSP-001, clinicaltrials.gov identifier NCT03474809).

The main goals of this study are to evaluate certain analytical performances components of this product in a point-of-care environment, in particular the precision, sample type comparability and specimen stability of the product. Such data will support regulatory filing of a US FDA 510(k) premarket notification file and of a European IVD Regulation technical file to continue product commercialization in 2022, when this novel regulation will be effective.

study_start_date_type: Actual

status: Completed

study_completion_date_type: Actual

study_type: Interventional

primary_purpose: Other

enrollment_type: Actual

ipd_sharing: No

lead_sponsor: University Hospital, Limoges

intervention_type: Diagnostic Test

lead_sponsor_type: academique

status_simplified: Completed


title: ONe Year Follow-up in Patients Admitted for Emergency Coronary Angiography After Rescuscited Cardiac Arrest

acronym: ONYRCA

summary:
While 80 % of all sudden cardiac death (SCD) result from coronary artery disease (CHD) approximatively 2/3 of SCD occur as a first manifestation of the CHD. VF (ventricular fibrillation) is the main cause of SCD in acute coronary syndrome (ACS), and the 2017 ESC Guidelines for the management of acute myocardial infarction, recommended direct admission to the catheterization laboratory in survivors of out of hospital cardiac arrest (OHCA) with criteria for STEMI on the post-resuscitation electrocardiogram (ECG) (Class I, grade B). However, During the past few years, the number of immediate coronary angiography (CA) for suspected ACS in patients presenting an OHCA increased, with a survival rate at discharge in this subgroup of patients better, about 60 to 80% (1). However, the survival rate remains poor in the global population of OHCA and some survivors patients may have neurological sequelles, related to global anoxia consequences or altered quality of life related to cardiac function impairement .

While the survival rate at hospital discharge is well known, the investigators have few data on long term outcomes , particularly regarding cardiac and neurological states.

Therefore the main objective of this study is to evaluate prospectively, in an observational study, the one-year prognosis of patients with rescuscited OHCA in whom a CA for suspected ACS was performed in the university hospital of Montpellier. Only patients alive at discharged are considered for the follow-up to eliminate the in-hospital mortality .

The investigators aim to assess year neurological status using medical questionnaires at one year follow-up(primary end point). The investigators hypothesize that 10% of patients will discharged alive from hospital with severe neurological sequelae at 1 year.Secondary end point will evaluate cardiac status, quality of life and pronostic factors of adverse outcome.

study_type: Observational

time_perspective: Prospective

ReferenceType: result

ReferenceCitation: Patel N, Patel NJ, Macon CJ, Thakkar B, Desai M, Rengifo-Moreno P, Alfonso CE, Myerburg RJ, Bhatt DL, Cohen MG. Trends and Outcomes of Coronary Angiography and Percutaneous Coronary Intervention After Out-of-Hospital Cardiac Arrest Associated With Ventricular Fibrillation or Pulseless Ventricular Tachycardia. JAMA Cardiol. 2016 Nov 1;1(8):890-899. doi: 10.1001/jamacardio.2016.2860.

ReferenceCitation: von Steinbüchel N, Wilson L, Gibbons H, Hawthorne G, Höfer S, Schmidt S, Bullinger M, Maas A, Neugebauer E, Powell J, von Wild K, Zitnay G, Bakx W, Christensen AL, Koskinen S, Formisano R, Saarajuri J, Sasse N, Truelle JL; QOLIBRI Task Force. Quality of Life after Brain Injury (QOLIBRI): scale validity and correlates of quality of life. J Neurotrauma. 2010 Jul;27(7):1157-65. doi: 10.1089/neu.2009.1077.

ipd_sharing: Undecided

ipd_sharing_description: NC

lead_sponsor: University Hospital, Montpellier


type: Other Identifier

title: Role of Individualized Versus Traditional Exercise in Combating Fatigue in Fatigued Multiple Sclerosis Patients

acronym: REEN-SEP

summary: The objective of this project will be to characterise the benefits of an exercise programme adapted to each individual's abilities compared to a traditional exercise programme with the aim of reducing perceived fatigue and improving the quality of life of Patients with multiple sclerosis.

status: Recruiting

study_completion_date_type: Anticipated

design_allocation: Randomized

primary_purpose: Health Services Research

enrollment_type: Anticipated

lead_sponsor: Centre Hospitalier Universitaire de Saint Etienne

intervention_type: Other

status_simplified: Ongoing


title: The Effectiveness of FRAME FR for ArterioVenous Fistula Repair in High-Flow Reduction, A Prospective, Monocenter Controlled Trial

acronym: FRAME

summary:
Patients with end-stage renal disease require permanent vascular access to enable safe and effective hemodialysis. An arteriovenous fistula (AVF), where a vein is mobilized and connected to an artery in the arm, is considered the gold standard and first choice for vascular access. After fistula creation, the vein is subjected to high pressure and flow, and undergoes remodeling. This includes the possibility of significant dilatation and intimal hyperplasia. Normal AVF flow required for effective dialysis is around 0.6 liters/min or 0.4-0.8 liters/min. However, in at least 20% of patients, excessive remodeling and dilatation of the fistula result in a high flow AVF with >2 liters/min.

High flow fistulas significantly increase the risk for the development of high output cardiac failure, skin breakdown, bleeding, hand ischemia, and other systemic complications. In cases of high flow AVF, venous reconstruction procedures, banding and/or plication, are often required to limit venous diameter and flow. The longevity of this procedure is limited as the reconstructed segment remodels and re-dilates due to ongoing arterial pressure. Banding and plication are both procedures that are designed to increase resistance to flow. Banding is performed by wrapping a segment of polytetrafluoroethylene (PTFE) around the outflow tract of the fistula, or by placing a suture around the fistula near the arterial anastomotic area to create a narrowing. Fistula plication involves narrowing of a short segment of the proximal venous outflow tract, usually accomplished by suturing or stapling the fistula for 2-6 cm. One of the notable systemic effects of a hemodialysis AVF is an acute decrease in systemic vascular resistance with a simultaneous increase in venous return to the heart, and thus an increase of the cardiac output. Cardiac failure occurs more frequently in patients with an access flow QA>2 l/min and CPR≥20%. Another adverse systemic effect of AV fistulas is pulmonary hypertension. The increased flow volume to the heart from an AV fistula yields an increase in pulmonary pressures. This can limit pulmonary vasodilation and result in pulmonary hypertension.

design_allocation: Non-Randomized

primary_purpose: Treatment

lead_sponsor: Groupe Hospitalier Paris Saint Joseph

intervention_type: Device


title: Observational Study of Basal Cell Carcinoma Operated at Montpellier University Hospital and Millau Hospital From February 2020 to February 2021 - Study of Correlation Between Localisation and Recurrence, and Other Criterias

summary:
.During one year all the resected basal cell carcinomas (BCC) analyzed in Montpellier University Hospital Anatomopathology unit were included in this study. Localisation and histological characteristics were collected. All the recurrences of BCC were searched from the medical records (or histopathology request form).

From 804 BCC, 48 were recurrent BCC with or without complete first resection. Patients with recurrent BCC were contacted to obtain agreement and more informations about the first resection and some clinical informations like sun exposure and phototype.

The statistical analysis focused on the localisation of recurrent BCC (with a complete first resection) compared to localisations of primary BCC in this population. The goal was to identified localisations with an increased risk of recurrences.

time_perspective: Retrospective


title: Oral Health Assessment of Children in CP Class in REP/REP+ Areas in the Department of Hérault

summary: Few oral exams are performed on 6-year-olds (key age for carious disease). This project aims to increase the number of oral check-ups for 6-year-olds in fragile areas (REP/REP+ areas).


title: Relationship Between Alzheimer Disease and Diminution of the Three Macular Nervous Retinal Layers

acronym: RETEVAL

summary: Alzheimer disease is hard, long and expensive to diagnose. In order to help the clinician, a new biomarker in Alzheimer disease seems to be very useful. The retina, as a window of the brain, could offer a new way to diagnose this common disease. Indeed, a retinal atrophy could especially appear in Alzheimer disease. Besides, many aspects about retinal alteration, visual function and their link with the disease deserve to be more explored. So as to fill these gaps, a new study about retinal specificity in Alzheimer disease appears to be relevant.

primary_purpose: Diagnostic


title: Hypnosis in Virtual Reality in Patients in Protector Isolation Room for Aplasia in Clinical Hematology. Monocentric, Comparative, Randomized, Open Study.

summary:
Hematology patients are frequently treated in hospital for aplasia. Patients are then placed in protective isolation room. This situation of protective isolation can represent a significant source of stress and anxiety for the patient. Hypnosis is already used to treat anxiety in patients with cancer.

The purpose of this study is to evaluate the impact of virtual reality medical hypnosis sessions on anxiety and chronic pain of patients hospitalized for aplasia in order to broaden the supportive care proposals in the clinical hematology service of Sévigné Private Hospital.

primary_purpose: Supportive Care

lead_sponsor: Hôpital Privé Sévigné


title: Management of Patients Suspected of COVID 19 With Ultra Low Dose Thoracic Scanner

acronym: COVID-19 ULD

summary:
The year 2020 was marked by the emergence of a new respiratory disease: COVID19 related to an infection with the coronavirus SARS-CoV-2 (name given by the WHO on February 11, 2020). Initially appearing in China, in the province of Hubei, this epidemic has rapidly spread to be declared a global pandemic on March 12, 2020 by the WHO.Given the current context of the COVID-19 epidemic, strict hygiene measures have been taken in scanning rooms with systematic bio-cleaning. Strategies have been modified as a matter of urgency, with changes in the practices of electro radiology manipulators who work in "isolation" to avoid contamination. The number of scanners has increased exponentially following the curve of the epidemic, making it more and more difficult to systematically check the images before the patient leaves the room. To ensure sufficient image quality for interpretation of all scans, a complementary acquisition in ULD, with very low exposure, was systematically added to the acquisition protocol. The standard acquisition in LD, associated with this acquisition in ULD remain well below the diagnostic reference thresholds dictated by the nuclear safety authority (NRD: 350 mGy.cm. In Nîmes: LD: 100 to 150 mGy.cm and ULD: < 15 mGy.cm). These two acquisitions allow us to avoid breathing and movement artifacts, etc., without having to have the patients return for a new scan in case of a bad acquisition. This avoids an overexposure of the staff to the risk of infection by the SARS-CoV-2 virus.

The main objective of this retrospective study is to evaluate the diagnostic performance of ULD vs. LD for the accurate diagnosis of COVID-19 pneumopathy which presents a particular ground glass pattern

Our study will demonstrate that the ULD scanner can be used in the search for COVID-19 pneumopathy and thus limit the exposure of patients to X-rays, especially since thoracic scans are often repeated.

lead_sponsor: Centre Hospitalier Universitaire de Nīmes


type: Registry Identifier

title: Programme d'Éducation Thérapeutique et d'Accompagnement Infirmier Vers Les Soins de Support, Chez Les Patientes Sous Hormonothérapie Pour un Cancer du Sein Non métastatique

acronym: ETAPH

summary: To compare the efficacy of the addition of a therapeutic education program combined with nursing phone follow-up, compared to conventional management alone, on the management of adverse events (AEs) related to adjuvant hormone therapy during the first year of treatment in patients with non-metastatic breast cancer.

ipd_sharing_description: The study sponsor is the owner of the data and no use or transmission to a third party may be made without its prior consent. All information resulting from this clinical research protocol is considered confidential.

lead_sponsor: Centre Hospitalier Emile Roux


title: Retro-prospective Evaluation of the Clinical Safety and Effectiveness of Hydrophilic Acrylic Intraocular Lens

summary: Evaluation of the clinical safety and effectiveness of hydrophilic acrylic intraocular lens

time_perspective: Other

lead_sponsor: Carl Zeiss Meditec AG

lead_sponsor_type: industriel


title: Adult Autoimmune Myopathies (MAIA): Clinical and Immunological Characterization, Constitution of a Patient Library

acronym: MAIA

summary: This study corresponds to a monocentric prospective cohort of adult patients presenting a suspicion of idiopathic inflammatory myopathy. It will allows the constitution of an organized collection of longitudinal clinical data as well as collection of biological samples, including blood sample, urine, stool and muscle specimen.

lead_sponsor: University Hospital, Brest


title: Étude Exploratoire Des Performances de Diagnostic Électrocardiographique de l'Apple Watch augmentée d'un Algorithme d'Intelligence Artificielle

summary: This observational exploratory prospective study will evaluate the performance on an Artificial Intelligence (AI) solution interpreting ECG (electrocardiogram) collected from an Apple Watch (AI-AW) in the detection of Atrial Fibrillation (AF)

time_perspective: Cross-Sectional

lead_sponsor: Cardiologs Technologies

location_facility: Institut Cardiologique Paris Sud Hôpital Privé Jacques Cartier


title: Assessment of Peripheral Veins Doppler Ultrasound for Diagnosis of Acute Right Heart Failure in Suspicion or Follow-up of Pulmonary Hypertension

acronym: CODOVEIN

summary: Occurrence of acute right heart failure (ARHF) remains common during pulmonary hypertension (PH). Right atrial pressure (RAP) invasive measurement is the gold standard to diagnose ARHF in order to improve diuretic treatment management. Existence of indirect signs of ARHF on venous Doppler ultrasound waveform has long been described, but correlation with RAP has not been properly established yet. It is the aim of our study in order to obtain an additional tool to manage ARHF.

lead_sponsor: Poitiers University Hospital


title: Evaluation of PET TDM FDG-Choline as a Decision-making Tool for Routine Care on Inclusion on the Liver Transplant List for Hepatocellular Carcinoma

acronym: TEP CARE

summary: HCC is the most common malignant liver tumor for which liver transplantation is one of the pivotal curative treatments. The best possible selection of patients who are candidates for transplantation is essential in the current context of a shortage of transplants. Performing a PET CT scan is not currently recommended in the pre-liver transplant workup for HCC. However, PET CT using in a complementary manner the FDG and Choline tracers appears promising in the management of HCC in view of its wide use in oncology and its major diagnostic and prognostic contribution compared to conventional imaging. In order to address this issue, a prospective cohort study including patients from the University Hospital of Rouen and Lille with hepatocellular carcinoma meeting the criteria for indication of liver transplantation validated in SPC will be set up, the main objective of which will be to assess the decision-making contribution of PET TDM FDG and Choline in addition to conventional imaging in the pre-transplant assessment.

lead_sponsor: University Hospital, Lille

intervention_type: Radiation


title: Intra and Inter- Observer Reproducibility of Ankle Dorsiflexion Measure With a New Tool

acronym: EQUINOM

summary:
The Achilles' tendon is the largest and most resistant tendon in the body. When the triceps contracts, the Achilles' tendon is responsible for plantar flexion of the ankle. When the triceps are not contracted, the Achilles tendon is the main component in limiting dorsiflexion of the ankle, a major component of the gait pattern. The limitation of this dorsiflexion of the ankle can be caused by a shortening of the Achilles tendon.

This equine whose prevalence in the general population is greater than 50% according to Kowalski, appears to be a risk factor in many pathologies of the foot and ankle.

Currently, in clinical practice, the measurement of passive dorsiflexion of the ankle is empirically measured by the Silfverskiold test. However, the definition of a retraction varies according to the authors, in particular because of the absence of normalization of the force applied on the forefoot, or of the absence of uniformization of the angulation applied. This research is based on the hypothesis that a new measurement tool would be more efficient and more reproducible for measuring dorsiflexion of the ankle.

primary_purpose: Basic Science

lead_sponsor: GCS Ramsay Santé pour l'Enseignement et la Recherche


type: EudraCT Number

title: A Phase I Study to Compare Pharmacokinetic Parameters of Firibastat and Its Metabolites (EC33 and QGC515) in Healthy Subjects Versus End Stage Renal Disease (ESRD) Patients After a Single Oral Administration of Firibastat 500 mg

summary: The study is a multicentre, open label, phase I, two arms study to compare pharmacokinetic of firibastat after a single oral dose of firibastat 500 mg in fourteen healthy male volunteers and in fourteen End Stage Renal Disease (ESRD) patients not yet in dialysis.

lead_sponsor: Quantum Genomics SA

intervention_type: Drug


title: Validation and Comparison of a Virtual Reality Protocol in Children Without Vestibular Pathology and Children With Chronic Vestibular déficits : Prospective Study ReViCHILD

acronym: ReViCHILD

summary:
Vestibular information is important in establishing a child's static and dynamic postural control. Any vestibular deficit can have major consequences on development, spatial cognition and quality of life.

In order to interact with the world around us, we must simultaneously integrate different sources of sensory informations (vision, hearing, perception of the body...). The brain integrates these different sensory components to form a unified and coherent perception: this is multisensory integration.

Multisensory integration has been studied using virtual reality in adults, in the "spatial orientation" team of the Center for Integrative Neurosciences and Cognition. These experiments were carried out on healthy subjects and in weightless situations (international space station or parabolic flight). However, no protocol has been developed in children or in subjects with vestibular deficit. Virtual reality is interesting for developing such a protocol because it creates multisensory stimulation capable of promoting visual and proprioceptive compensation of the vestibular deficit.

It induces an immersion of the patient in a virtual spatial and temporal environment difficult to carry out with traditional vestibular rehabilitation techniques. Its main advantage is that it is a fun and safe interactive diagnostic and therapeutic tool, which is particularly suitable for children. Being able to modulate certain sensory information using virtual reality, in children without vestibular function deficit and in children with vestibular function deficit, will make it possible to better understand the role of the vestibule in the construction of the self in relation to space and environment. In addition to the scientific aspect, the diagnostic and therapeutic benefits are potentially numerous.

The objective of the study is to determine a reliable, well-tolerated and age-appropriate virtual reality protocol in children without vestibular deficit and in children with chronic vestibular deficit, making it possible to study the hand-eye coordination.

lead_sponsor: Assistance Publique - Hôpitaux de Paris


title: Faecal Microbiota Characterization in Lynch Syndrome (LS) Patients With or Without Colorectal Neoplasia ( AAS-Lynch-Microbiote)

acronym: Microbiote

summary:
Colorectal cancer (CRC) is the second cause of cancer-related death in western countries. CRC prevention and screening are major public health issues. Better knowledge of colorectal carcinogenesis could lead to better prevention. Gut microbiota (GM) is a complex community of bacteria, fungi, protozoa, viruses and bacteriophages which live in a symbiotic and epigenetic relationship with the host. GM can promote either digestive health or CRC through inflammatory and proliferative effects.

Lynch syndrome (LS) is the most common familial CRC syndrome with a lifetime CRC risk of 52% in women and 69% in men. The risk of CRC depends upon type of altered mismatch-repair gene and environmental factors (diet, exercise, obesity, tobacco and alcohol intake, etc.). Regular surveillance including annual or biannual colonoscopy is recommended in LS patients.

Chemoprevention has the potential to represent a cost-effective intervention in these high-risk patients and could allow a delay in colonoscopy surveillance. Regular low dose aspirin use is associated with a 20 to 30% reduction in the risk of sporadic colonic adenomas and CRC. The real benefit of aspirin is still to be consolidated. AAS-Lynch trial is an ongoing prospective multicenter (n=37), double-blind, placebo-controlled, randomized clinical trial, designed to investigate whether daily aspirin, at a dose of 100 or 300 mg compared with placebo, would decrease the occurrence or recurrence of colorectal adenomas in LS patients. The primary endpoint is the number of patients with at least one adenoma detected by chromo-endoscopy 48 months after initial colon clearance. At randomization and at the end of study, stool collection, blood collection, quality of life questionnaire, validated food frequency questionnaire (SU-VI-MAX2) and physical activity questionnaire are performed.

The ongoing AAS-Lynch study allow accessing to a unique fecal collection in very well characterized LS patients including a comprehensive dietary evaluation at high risk for colorectal neoplasia and planned colonoscopy surveillance during a 48 months follow-up, exposed or not exposed to chronic low dose aspirin. The expertise of the scientific consortium with state of the art microbiota analysis, the comprehensive collection of data and the prospective design of the study will allow the evaluation of the true role of gut microbiota in CRC carcinogenesis.

location_facility: Hôpital Avicenne, AP-HP, Service de Gastroentérologie et Oncologie Digestive


title: Impact of Hyperoxia and Involvement of the Immune System in Diving Accident

acronym: OXYDIVE

summary:
The impact of oxygen therapy in many pathologies has been subject of recent work, arguing both favourable and harmful effects. Consequently, one can wonder about the influence of hyperoxic gas mixture during diving on the genesis of decompression sickness, but also about the systematic application of normobaric and hyperbaric oxygen in case of proven decompression sickness.

In mammals, normoxic concentrations have been redefined at 20-100 mbars at the extracellular level and below 10 mbars in the mitochondria.

Under hyperbaric conditions, most of the oxygen being dissolved in blood plasma, a state of hyperoxia is established which escapes the usual delivery and regulation system represented by red blood cells.

The results of our team's previous work suggest a specific effect of diving on the levels of circulating mitochondrial DNA (mtDNA), suggesting cellular destruction linked to hyperoxia/hyperbaria. In fact, our studies, carried out on both animals and human divers, have shown that diving accident leads to an increase in mtDNA levels and an immune reaction through the mobilisation of leukocytes.

The main objective of this study is to compare the influence of oxygen partial pressure levels on the evolution of clinical and biological variables during hyperbaric oxygen therapy sessions in healthy versus injured divers.

lead_sponsor: Direction Centrale du Service de Santé des Armées

location_facility: Hôpital d'Instruction des Armées Sainte-Anne

intervention_type: Procedure


title: Observational Descriptive Study of Stress Symptoms Related to the COVID-19 Outbreak in a Cohort of Osteoarthritis Patients

summary:
While the coronavirus pandemic has spread rapidly around the world, it has generated a considerable degree of fear, concern and anxiety among the population in general and among certain groups in particular, such as older persons. Initial findings from studies in China indicated the presence of moderate to severe psychological impact in a significant proportion of individuals and an increased prevalence of post-traumatic stress symptoms. It should also be noted that other types of symptoms, such as anxiety and depression, appeared to persist over time and to a greater extent.

Osteoarthritis can develop in any joint, but most often affects the knees, hands and hips. People with osteoarthritis are often older and sometimes more frail than the general population. The main recommendations for non-drug treatment of osteoarthritis include education, physical activity and structured exercise programmes with or without weight reduction. Due to the confinement associated with COVID-19, many patients have had to stop exercise/physical activity and postpone prosthetic surgery. Apart from the context of delay in surgery, there is little data available on the impact of the pandemic on people with arthritis. Several questions are therefore still pending concerning the impact of the pandemic on these patients.

The investigators hypothesise that the following therapeutic modalities have been disrupted during this period: access to care, scheduling of prosthetic surgery, consumption of painkillers or NSAIDs, recourse to physical activities, recourse to physiotherapy sessions, weight changes, level of pain.... Our objective is to evaluate the physical, social, psychological and behavioural consequences of the COVID-19 pandemic in a cohort of osteoarthritis patients.


title: Study of the Intestinal Microbiota of Patients With Systemic Sclerosis

acronym: SCLEROMICROBIO

summary:
The term gut microbiota describes the entire intestinal microbial communities. Studies have established the important role played by the gut microbiome in modulating vital functions of the healthy host. The physiological effects of the microbiota for the host are, for the most part, beneficial. In several pathologies, an imbalance in the composition of the microbiota has been demonstrated.

Systemic sclerosis is an autoimmune, disorder of the connective tissue, characterized by vascular lesions, immunological abnormalities, and fibrosis of skin and internal organs As in many inflammatory diseases, there are painful digestive manifestations in systemic scleroderma that affect up to 90% of patients. The exact pathophysiology of the digestive involvement in systemic sclerosis is uncertain. The digestive manifestations of systemic sclerosis are frequent and can affect the entire digestive system.

However, there are few studies of the intestinal microbiota in this disease, which seems to be part of the same continuum of diseases with abnormalities of innate immunity. By analogy with chronic inflammatory bowel diseases, particularly Crohn's disease, we have raised the question of the existence of dysbiosis during scleroderma which could lead to episodes of acute, severe and recurrent inflammation of the peritoneum under the influence of triggering factors. The long-term prospects would be to look for ways to prevent attacks or to treat them more rapidly and effectively by using therapeutic targets in the intestinal microbiota.

The study population will be seen in the usual care setting, identically to all patients with systemic sclerosis treated in the department.

In case of an inflammatory disease outbreak, and depending on its severity, the patient will be seen again in consultation or hospitalized. Appropriate complementary examinations (biology, imaging, endoscopy) will be carried out and the treatment adapted.

location_facility: Hopital Saint Antoine - service de médecine interne


title: Rheumatologic Adverse Events and Immunotherapy in Oncology

summary:
In this study, every patient with cancer who is going to be treated by immunotherapy will fill in a form. In this form, we try to determine if he presents rheumatologic complications of his immunotherapy. If the patient answers yes to one question on the form, the patient will be see in rheumatologic consultation to explore his clinical signs.

The number of patients referred in consultation thanks to this questionnaire will be compared to the number of patients who would have been spontaneously referred by the oncologist.

The aim of this questionnaire is to optimise the management of rheumatological effects secondary to immunotherapy.

primary_purpose: Screening

ipd_sharing_description: NO IPD


title: Impact of Infectious Diseases Consultation on Vaccination Coverage Among People Waiting for a Kidney Transplant at the Clermont-Ferrand Hospital

acronym: PREVAGREF

summary: Solid-organ transplant patients are at increased risk of infectious diseases. Among this population, infectious diseases may be life-threatening or lead to graft rejection. Their prevention is an important challenge. Despite specific national recommendations, vaccination is underutilized. That is why we propose a dedicated infectious diseases consultation during pre-kidney transplantation assessment.

primary_purpose: Prevention

lead_sponsor: University Hospital, Clermont-Ferrand


title: Assessment of One-shot Cardiac-cervical-intracranial MRI in the Etiological Work up of Ischemic Stroke and Transient Ischemic Attacks

acronym: Concise

summary: Stroke is a major public health issue in developed countries. A full etiological work up within a short time is critical to implement the appropriate preventive treatment. The etiological work up is actually based on a clinical examination and on a group of paraclinical examinations. The realization of the standard strategy is time consuming, and increase the cost of the medical care. A non-invasive one-shot examination of the heart, the aorta and the cervical and intracranial arteries (cci-MRI) could overcome these disadvantages.The investigator therefore propose to carry out an overall assessment of the performance of the cci-MR in the etiological work up of ischemic strokes and TIAs compared to the reference strategy

study_start_date_type: Anticipated

status: Not yet recruiting

lead_sponsor: Hospices Civils de Lyon


title: Influence of Keratoconus on Stress at Work

acronym: KERATOSTRESS

summary:
Keratoconus is a progressive disorder in which central and paracentral corneal stromal thinning occurs.

No studies evaluated the influence of keratoconus on stress at work, nor the influence of treatments of keratoconus on stress at work, including Quality of Life at work and on perception of work. Moreover, it has been shown that some pathologies had greater influence in some occupations, also depending on other characteristics of individuals such as age, sex or socio professional groups.

Therefore, we hypothesized that keratoconus 1) will influence stress at work including QoL at work and perception of work, 2) will have a greater influence in some occupations and depending on age, sex, or stage of keratoconus, 3) will induce stoppage of work and occupational reclassifications.

intervention_type: Behavioral


title: Retro-prospective Evaluation of the Clinical Safety and Effectiveness of Hydrophilic Acrylic Intraocular Lens (509)


title: Toxicokinetic Study of Dichlorobisphenol A After an Oral or Dermal Single Dose in Healthy Volunteer.

acronym: PRECEPT

summary: The objective of this study is to determine toxicokinetic parameters of deuterated d12-Cl2BPA after the administration of a single low dose (50 µg/kg) to healthy volunteers via oral or dermal routes.


title: A Multicenter, Open-Label Study to Evaluate the Safety and Performance of DuraLock-C 4.0%, 30.0%, and 46.7% for the Maintenance of Central Venous Catheter Patency in Adult Hemodialysis Subjects Treated in Clinic

summary: To evaluate the safety and performance of DuraLock-C 4.0%, 30.0%, and 46.7% for the maintenance of central venous catheter (CVC) patency in adult hemodialysis (HD) patients

ipd_sharing_description: Publication undecided

lead_sponsor: Medical Components, Inc dba MedComp

location_facility: Clinique HEMERA Pays de Caux, 14 .A avenue Foch


title: Contribution of Indocyanine Green Angiography in the Detection of Parathyroids and the Prevention of Hypoparathyroidism Post Total Thyroidectomy

acronym: HYPOCAAVI

summary:
Hypoparathyroidism is the most common complication after a total thyroidectomy surgery. It becomes permanent after 6 months.
Untreated permanent hypoparathyroidism is a source of numerous complications in general and therefore requires lifelong replacement therapy resulting in a significant deterioration in quality of life.
The intraoperative use of indocyanine green (ICG) angiography has recently been described as a reliable means of detecting parathyroidism and predicting the risk of postoperative hypoparathyroidism.
This use could prove to be a way to preserve parathyroid in vivo and thus reduce post-operative hypoparathyroidism rates.

ipd_sharing: Yes

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


title: Anatomopathological Analysis and Clinical Evolution After Radiological Removal of Retrievable Vena Cava Filters

summary:
Pulmonary embolism (PE) is a common pathology causing significant morbidity and mortality. It is usually secondary to migration through the inferior vena cava (IVC) of a formed thrombus in the veins of the lower limbs or pelvis. The inferior vena cava filter (IVCF) is a medical device whose purpose is to prevent thrombus migration from the veins of the legs and pelvis to the pulmonary arteries, thus preventing the occurrence of Pulmonary embolism (PE).

There is no data on the interactions of Retrievable inferior vena cava filters (IVCF) with the inferior vena cava (intrafilter thrombi, insertion through the venous wall) although it may modify the evolution after IVCF retrievable.

lead_sponsor: Centre Hospitalier Universitaire de Saint Etienne

intervention_type: Biological


title: Natural History of Asymptomatic Superior Mesenteric Arterial Stenosis Depends on Celiac and Inferior Mesenteric Arteries Status.

summary: The aim of this study was to evaluate asymptomatic superior mesenteric artery (SMA) stenosis prognosis according to the presence of coeliac artery (CA) and/or inferior mesenteric artery (IMA) associated stenosis.


title: Assessment of New Physiological, Radiological and Activity Markers in Patients Treated by Spinal Cord Stimulation for Chronic Lower Limb Pain

summary: By combining the usual care of patients eligible for spinal cord stimulation (SME) with measurements of the HRV index (Heart Rate Variability), objective measurements of activity (number of steps, quality of sleep) and measurements of connectivity obtained by anatomical and functional magnetic resonance imaging (fMRI), the collection of preliminary data necessary for the analysis of markers correlated with the efficiency of stimulation will be possible. Ultimately, these markers could be used to optimize the perioperative management of these patients.

lead_sponsor: Fondation Ophtalmologique Adolphe de Rothschild

location_facility: Fondation Ophtalmologie Adolphe de Rothschild


title: Study Comparing Satisfaction of Hospitalized Patients Receiving Invasive Care for Cancer Treatment, With Snoezelen Session Versus Standard Care (SNOEZELEN)

acronym: SNOEZELEN

summary:
This is a monocentric, comparative, open-label, randomized, crossover study enrolling patients hospitalized in Strasbourg Europe Cancerology Institute, receiving repeated invasive care for cancer treatment.

The purpose of this study is to compare the satisfaction of patients, regarding their perception of care, with or without Snoezelen session.

lead_sponsor: Institut de cancérologie Strasbourg Europe


title: Personalized Multichannel Transcranial Direct Current Electrical Stimulation (tDCS) in Drug-resistant Epilepsy: Evaluation of Therapeutic and Neurophysiological Effects

acronym: GALVANI PS-1

summary:
This project aims to conduct a pilot study based on the targeting of the epileptogenic zone previously localized very precisely by stereoelectroencephalography (SEEG). SEEG is used as part of the pre-surgical assessment. It consists, thanks to the intracerebral implantation of electrodes in the brain of patients, to perform an intracerebral electrophysiological recording and thus to precisely explore the epileptogenic regions.

In order to study the neuromodulatory and therapeutic effects of tDCS on epileptic brains, non-invasive techniques for measuring electrophysiological brain activity such as magnetoencephalography (MEG) and high-resolution electroencephalography (HR EEG) will be used.

Finally, since epilepsy is considered to be a disorder of brain functional networks associated with disturbed brain connectivity, the effects of tDCS on cortical excitability by studying the variations in functional connectivity induced by stimulation will be studied.

lead_sponsor: Assistance Publique Hopitaux De Marseille

location_facility: Service d'Epileptologie et de Rythmologie Cérébrale


title: Variations of Portal Flow During the Respiratory Cycle in Healthy Volunteers

acronym: RESPIFLUX

summary: The analysis of portal vein blood flow is important when assessing the severity and progression of liver disease. It is important to understand normal liver regulation in order to appreciate the evaluation of the effect of treatment during the disease progression. The influence of respiration on hepatic hemodynamics is still poorly understood, although some studies have shown a significant impact. The purpose of this project is to quantify the blood flow variations in the portal vein at different positions during the respiratory cycle by using a fast MRI sequence and an Echo Planar (EPI) acquisition.

lead_sponsor: Centre Hospitalier Universitaire, Amiens


title: Acute Reno-Cardiac Action of Dapagliflozin In Advanced Heart Failure Patients on Heart Transplant Waiting List: a Multicenter, Double-blind, Randomized Clinical Trial.

acronym: ARCADIA-HF

summary:
In the DAPA-HF trial, the use of dapagliflozin, an inhibitor of sodium-glucose cotransporter 2 (SGLT2), reduced significantly the risk of worsening heart failure or death from cardiovascular causes compared to placebo among patients with heart failure (HF) and a reduced ejection fraction. This new drug offers a very potent and interesting therapeutic pathway since it reduces clinical congestion, it preserves glomerular renal function, does not appear to cause symptomatic clinical hypotension and improves symptoms and quality of life compared to placebo.

Advanced heart failure patients with reduced ejection fraction represent a small and severe subgroup of heart failure of patients with frequent worsening heart failure events and high rates of death. The effect of dapagliflozin in this subgroup of patients was not assessed in the DAPA-HF study. The therapeutic profile of SGLT2 inhibitors appears to be of high interest, since this group of patients has a poor tolerance to usual heart failure drugs, frequent worsening renal function and congestive symptoms persistence with poor quality of life scores.

Soluble urokinase-type plasminogen activator receptor (suPAR) is a signaling glycoprotein considered to be involved in the pathogenesis of kidney disease. It is associated with the risk of acute kidney injury in different clinical and experimental situation. It is also a new validated biomarker predictive of adverse clinical outcome in heart failure patients. This biomarker allows a better risk stratification in heart failure patients after adjustment for Nt-proBNP.

As a useful biomarker implicated in both heart failure and acute kidney injury, suPAR seems to be an interesting biomarker to assess cardio-renal benefits of dapagliflozin.

The aim of this study is to investigate if a treatment by dapagliflozin reduces significantly suPAR compared to placebo in a population of advanced heart failure patients, candidates to heart transplantation. The effect of dapagliflozin compared to placebo will also be assessed on other secondary heart failure outcomes in this patient population.

location_facility: Hôpital Pneumologique et Cardiovasculaire Louis Pradel


title: Diagnostic échographique Non-invasif Des Maladies Chroniques du Foie en Consultation d'hépatologie

acronym: DIACEPA

summary: Early screening and monitoring of chronic liver diseases in hepatology practice has become crucial. To achieve this goal, hepatology clinics need simple and available tools at the point-of-care to perform disease severity assessment. The objective of this study is to assess the performance of a new non-invasive ultrasound-based system for the assessment of liver fibrosis and steatosis severity, via ultrasound biomarkers such as tissue stiffness (correlated to fibrosis severity) and ultrasound tissue attenuation (correlated to steatosis extent).

lead_sponsor: E-Scopics


title: Follow-up of Anterior Cruciate Ligament Reconstruction

summary: Rupture of Anterior Cruciate Ligament (ACL) is a common pathology, but is subject to variability of associated lesions, surgical management and rehabilitation.


title: Impact of Music Added to the Usual Treatment on the Anxiety of Patients Undergoing Outpatient Cataract Surgery With Topical Anesthesia: Randomized Controlled Trial

acronym: MUSICAT

summary:
Most patients treated for cataract surgery benefit from a short outpatient course with topical local anesthesia.

Having to undergo surgery, especially on the eye, without being asleep, can be stressful. Sometimes waiting in a waiting room with other patients can increase this stress. Patient anxiety may increase blood pressure potentially leading to the prescription of nicardipine to allow surgery to be performed. The patient's anxiety also increases the surgeon's stress, which can alter the conditions for performing the intervention and increase the risk of intraoperative complications.

Besides the administration of anxiolytics, nurses have few options for patients with anxiety. However, the treatment response time is not always appropriate and the patient's cooperation during the procedure can sometimes be impaired.

The effect of music on preoperative anxiety has been evaluated in several studies and has shown a significant decrease in anxiety before surgery.

MusicCare® is a "digital treatment" based on the principles of hypnoanalgesia which has been tested in the management of patients with various pathologies (depression, Alzheimer's disease, chronic pain, etc.) and has shown relative effectiveness. the absence of intervention on the pain and anxiety of patients.

In the context of cataract surgery with topical local anesthesia, we would like to assess the contribution of offering the MusicCare® listening device on patients' anxiety about absence


title: Randomized, Controlled Study of the Effectiveness of Mental Contrasting and Implementation Intention in the Management of Apathy in Schizophrenia

acronym: COMEIA

summary:
Schizophrenia is a mental pathology that concerns 1% of the French population, characterized by heterogeneity of symptoms. One of them, apathy is defined as a multidimensional psychopathological state manifested by a decrease in motivation. This deficit is most common in schizophrenia and impacts the functional outcome of patients. To date, no treatment has shown a significant effect on this symptom. In other pathologies with a motivational deficit, the technique of Mental Contrasting and Implementation Intention (CM-II) showed interesting effects in improving motivation, reducing the effort related to the action.

The investigators aim to propose the CM-II technique to individuals with schizophrenia to improve apathy.

The investigators expected that the CM-II technique will allow an improvement of apathy which will have beneficial effects on other psychological factors (e.g., depressive symptoms). In addition, the implementation of the CM-II will provide help to global management.

lead_sponsor: University Hospital, Montpellier


title: Rapid Detection of COVID-19 by Portable and Connected Biosensor : Biological Proof of Concept

acronym: COR-DIAL-S

summary:
The main objective of this CorDial-S proof-of-concept study is to evaluate the ability to detect COVID-19 infection in nasopharyngeal swabs with CorDial-S and compare it to the PCR technique currently in use. Saliva analysis will be the subject of secondary analysis.

The CorDial-S medical device could allow the specimens to be analyzed using a small portable device and the results to be returned in minutes to the medical team and the patient, and communicated in real time with a telemedicine and remote monitoring system to the health authorities to allow the necessary protective, containment and therapeutic management measures to be put in place if necessary.

The benefits would be

greater sensitivity
a great speed because 8tests could be performed at the same time with a result in a few minutes
a very high specificity at least equivalent to PCR.

This new diagnostic strategy could become extremely valuable in the fight against COVID-19, especially in the case of very long-term persistence and incomplete vaccination of the French and foreign population.


title: Evaluation of Evolution of Perceived Stress in General Practice Residents of Rouen and Caen During COVID-19 Sanitary Crisis

summary: Over the last several years, distress among healthcare professionals is well described, and general practice residents are also affected. Because of COVID-19 sanitary crisis, stress factors are increased, and that may cause anxiety, exhaustion, psychic distress, depression, addictions, or post traumatic stress.

lead_sponsor: Centre Hospitalier Eure-Seine


title: Evaluation of Professional Practices in the Prescription of Biological Treatments for RA Taking Into Account IL6 as a Biomarker

acronym: REMISIX

summary:
Several studies have shown the relevance of the IL6 level before treatment or after 6 months, as a predictive biomarker for the persistence of remission. The IL6 assay is now routinely available using the instruments available at the Montpellier University Hospital and with reagents provided by the ROCHE Laboratory. Moreover medical practices should incorporate this parameter. However, relevant threshold shlould be defined before being able to integrate biomarkers such as IL6 for monitoring bDMARDs in an algorithm.

The medical staff of Clinical Immunology Unit has decided to include the dosage of IL-6 during a routine biological assessment during patient visit to follow the new EULAR recommendations . This measument will be perfom in addition to the CRP and biochemical parameters on subjects with active RA or in remission upon the introduction of biological treatments or JAKi or during remission after at least 6 months of treatment. From March to July 2021, 200 patients will beenrolled and will benefit of this assessement. The investigators will retrospectively define clinical correlations with serum IL6 levels in order to define a threshold. In the second stage, a decisional algorithm based on the results of this project will be create. This will allow an improvement of the medical practices thanks to the integrationof of serum IL6 dosage as a standard during patients visits. The IL-6 assay will be performed on the e801 module of the Cobas lines (Roche Diagnostics) currently in place in the Biochemistry and Hormonology laboratory. The Elecsys® IL-6 - Roche Diagnostics test, high sensitivity, is an electrochemiluminescence immunoassay.


title: Evaluation of the Safety of Use of Anti-IL6 Receptor Antibodies to Reduce Allo-sensitization Post Allograft Nephrectomy ; a Pilot Phase II Study.

acronym: RAIPONS

summary: Graft nephrectomy is associated with massive allo-sensitization following this event. The occurrence of anti-HLA antibodies is a major barrier to perform a second kidney transplantation. Investigators propose here to evaluate in a phase II pilot study, the safety of the use of a single dose of Tocilizumab immediately before or after graft nephrectomy. The primary endpoint evaluated here is the occurrence of serious infectious complications following graft nephrectomy, with a treatment by Tocilizumab. Secondary endpoints evaluated here are - to evaluate all complications after graft nephrectomy, - and the Tocilizumab effectiveness to reduce anti-HLA antibodies at one year post nephrectomy.

lead_sponsor: University Hospital, Toulouse


title: Retrospective Study on the Incidence and Management of Anemia in Oncology

acronym: RESPIRE

summary:
The incidence of anemia ranges from 20 to 75% depending on the type of cancer. It is often present at diagnosis and increases with specific treatments. It has an impact on overall survival and quality of life. Its origins are multiple (pure iron deficiency or functional, malnutrition, dyserythropoiesis, insufficiency renal, hemolysis, chemotherapy, radiotherapy, targeted therapies).

Transfusion is the most common treatment offered in the management of anemia. The incidence of anemia and its consequences are often underestimated during cancer management.

Recommendations were published in 2012. An inventory of the incidence of anemia before and after the publication of these recommendations are proposed in order to assess their impact on daily practice.

lead_sponsor: Weprom

location_facility: Centre Jean Bernard - Clinique Victor Hugo


title: Tumescent Anesthesia Interest in Pain Management During a Dynamic Phototherapy (PTD) Session in Vertex Actinic Keratosis Treatment: a Single-center Prospective Randomized Study

acronym: ANTUKA

summary: This study focus on the efficacity of tumescent anesthesia in pain management during a photodynamic therapy on the vertex for treatment of actinic keratosis. To do this we carried out a prospective, randomized, controlled, open-ended study. Our aim is to show a 40% reduction in pain during photodynamic therapy session compared to a conventionally used analgesic method (paracetamol + cold water)

lead_sponsor: Poitiers University Hospital


title: An Open Label Phase II Basket Trial Exploring the Efficacy and Safety of the Combination of Niraparib and Dostarlimab in Patients With DNA Repair-deficient or Platinum-sensitive Solid Tumors

acronym: NIRADO

summary: Treatment will consist of a PARP inhibitor (niraparib) monotherapy priming period (cycle 0; 21 days); an anti-PD-1 antibody (Dostarlimab ; TSR-042) will then be added from C1D1 every 21 days in combination for the first 4 cycles, and then every 42 days. Disease will be assessed every 2 cycles (6 weeks) from C3D1 by CT-scan (or MRI or bone scan, if relevant). Patients still under treatment after 1 year may have tumor evaluation spaced out every 3 cycles

lead_sponsor: Gustave Roussy, Cancer Campus, Grand Paris


title: National Exhaustive Cohort of Hereditary Stomatocytoses and Other Channelopathies Affecting the Red Blood Cell

acronym: COHSTO

summary: Hereditary stomatocytosis is a heterogeneous group of rare constitutional diseases of dominant transmission in the vast majority of cases. The data concerning their clinical and biological presentation, and their evolution are few, and come from about thirty clinical cases. The constitution of an exhaustive French cohort of hereditary stomatocytosis will improve the establishment of the diagnosis and the management of patients

lead_sponsor: Assistance Publique - Hôpitaux de Paris

location_facility: AP-HP, Bicêtre Hospital, Pediatrics - Hematology - Reference center for Sickle cell anemia, Thalassemia and other constitutional diseases of the red blood cell


title: Modulation of Endothelial Dysfonction Using Vitamin C in Septic Shock Patients

acronym: MYTHICCS

summary: Compare the microcirculatory reactivity before and after a 30-minute intravenous infusion of 40 mg/kg vitamin C and evaluate intra-individual variation of hemodynamic parameters between T0 and T1.

ReferenceType: derived

ReferenceCitation: Lavillegrand JR, Raia L, Urbina T, Hariri G, Gabarre P, Bonny V, Bigé N, Baudel JL, Bruneel A, Dupre T, Guidet B, Maury E, Ait-Oufella H. Vitamin C improves microvascular reactivity and peripheral tissue perfusion in septic shock patients. Crit Care. 2022 Jan 21;26(1):25. doi: 10.1186/s13054-022-03891-8.

location_facility: Intensive care department- Hôpital saint Antoine


title: Macular Drusen Evolution in Patients With Intermediate Age-related Macular Degeneration (AMD) Taking Oral Food Supplementation: an Open-label,Single-arm Pilot Study

summary:
LT7082-001 is an open-label, single-arm pilot study. Patients with intermediate age-related macular degeneration (AMD) wil take T7082 during 12 months , an association of 4 food supplementations .

The study objectives are to describe morphological changes and evolution of drusen in macula after a 12-month of food supplementation and to assess the safety of T7082

lead_sponsor: Laboratoires Thea

intervention_type: Dietary Supplement


title: Segmental Exclusion of the Upper Limb and Peri-personal Space

acronym: EPPEX

summary:
This study is based on previous studies on the search of the limit of the peri-personal space. In a previous study, Gouzien et al. (2017) evaluated the peri-personal space of action of patients with upper limb amputations and sought a link between this space and the level of integration of their myoelectric prosthesis. We have decided to implement part of this protocol to evaluate the peri-personal space for another population with upper limb patholog: segmental exclusion of the upper limb.

Exclusion is a phenomenon that is very little studied but known to orthopedic surgeons and physical medicine and rehabilitation physicians. It is characterized by the non-use or underuse of a limb segment in the absence of central nervous system involvement. This phenomenon is compared to peripheral neglect. Most of the time, the patient is unaware of his disorder "he forgets his finger without realizing it", but this phenomenon can be reversible under verbal exhortation from a third party.

The aim of this study is to observe if there is a change in peri-personal space in patients with unilateral segmental exclusion.

lead_sponsor: Union de Gestion des Etablissements des Caisses d'Assurance Maladie - Nord Est

location_facility: Institut Régional de Médecine Physique et de Réadaptation


title: Evaluation of the Effectiveness of a Heart Rate Variability Biofeedback Training in the Management of Dysfunctional (Somatoform) Disorders

acronym: ECoDys

summary:
To study whether Heart Rate Variability (HRV) biofeedback training can improve abnormal head posture and painful symptomatology in patients with "cervical dystonia" not selected for DBS after extensive screening in a specialized unit but diagnosed " dysfunctional ".

Patients of the respiratory coherence group will receive HRV biofeedback training for 12 sessions during a 6 months-period. The hypothesis is that this kind of physiological noninvasive therapy increasing coherence respiratory, will reduce pain and patient's complain about their psychogenic abnormal head posture. Improvement of anxiety, depression and quality of life are expected.


title: The Efficacy of a Minimally Invasive Direct Cochlear Access Via the HEARO Procedure

summary: The objectives of this study are to explore the efficacy and safety of a robotic procedure for a minimally invasive cochlear implantation.

lead_sponsor: MED-EL Elektromedizinische Geräte GesmbH


title: Therapeutic Orientation Test in Thrombotic Microangiopathy

acronym: TOTEM

summary:
Haemolytic and Uraemic Syndrome (HUS) is a serious disease requiring rapid diagnosis and management. The atypical HUS diagnosis has been greatly improved by anti-CS antibody (Eculizumab) wich block alternative complement pathway activation. To rise treatment success, Eculizumab introduction should be as early as possible. In some secondary HUS (infection, drugs…) complement is also involved as "second-hit".

To date, there is no tool to confirm complement involvement in a HUS at diagnosis stage. This study suggest to evaluate a therapeutic orientation test, in order to determine the complement implication in HUS diagnosis. The test evaluates the complement deposits on endothelial cell surface in vitro, compared to a normal human serum.

In order to determine the test performance, first the positive or negative results will be compared to the HUS clinical evolution, treated or not by the clinician with Eculizumab. Second, the test results will be compared to the presence of alternative complement pathway regulation abnormalities.


title: Atrial Fibrillation in Young Patients: a Prospective Multicentre Registry

acronym: YOUNG-AF

summary: Atrial fibrillation is a rare cardiac arrhythmia in young (i.e. <= 35-year-old) patients. Etiological factors, current management and mid- to long-term outcomes remain unknown.

lead_sponsor: University Hospital, Caen


title: CPAP Observance During the COVID-19 (SARS-CoV-2) Pandemic

acronym: COVADENE

summary: The hypothesis of this work is that the COVID 19 pandemic and the associated lockdowns are likely to modify the adherence to positive airway pressure (PAP) treatments among patients with sleep apnea. Identifying these patients and identifying adherence "trajectories" over time would help mobilize human and telemedicine resources on the patients most in need.

ReferenceCitation: Bertelli F, Suehs CM, Mallet JP, Court-Fortune I, Gagnadoux F, Borel JC, Gaubert O, Molinari N, Bourdin A, Jaffuel D. Did COVID-19 impact Positive Airway Pressure adherence in 2020? A cross-sectional study of 8477 patients with sleep apnea. Respir Res. 2022 Mar 4;23(1):46. doi: 10.1186/s12931-022-01969-z.


title: Pilot Study of a Signal-processing Algorithm Aiming at Improving Speech-in-noise Intelligibility in Normal-hearing and Hearing-impaired Persons

acronym: AUDIOCAP 1

summary:
Nearly half a billion people suffer from disabling hearing loss. The most common form of hearing loss in adults is age-related hearing loss (ARHL), which causes a reduced ability to understand speech in noisy environments. The ability of people with ARHL to communicate is therefore greatly impacted, limiting their social interactions and thus their quality of life. Yet, the wear of hearing aids - which is the current standard rehabilitation treatment in such cases - does not lead to optimal satisfactory outcomes when it comes to understanding speech in noisy environments.

The objective of this pilot study is to test a new signal-processing algorithm, based on artificial intelligence, that aims at enhancing the intelligibility of speech-in-noise signals. The efficiency of the algorithm is compared to a standard denoising algorithm commonly used in hearing aids. The primary outcome measure is the word-identification performance of the participants, using the FrMatrix test (Jansen et al., 2012). Two secondary outcome measures are investigated: listening effort (self-assessed using a Likert scale, and measured through response times), and subjective preference (assessed in a paired-comparison task).

The study is conducted in 20 normal-hearing subjects and in 40 older (age ≥ 55 years) hearing-impaired subjects.

ReferenceType: background

ReferenceCitation: Amieva H, Ouvrard C, Giulioli C, Meillon C, Rullier L, Dartigues JF. Self-Reported Hearing Loss, Hearing Aids, and Cognitive Decline in Elderly Adults: A 25-Year Study. J Am Geriatr Soc. 2015 Oct;63(10):2099-104. doi: 10.1111/jgs.13649.

ReferenceCitation: Bentler RA. Effectiveness of directional microphones and noise reduction schemes in hearing aids: a systematic review of the evidence. J Am Acad Audiol. 2005 Jul-Aug;16(7):473-84. Review.

ReferenceCitation: Chong FY, Jenstad LM. A critical review of hearing-aid single-microphone noise-reduction studies in adults and children. Disabil Rehabil Assist Technol. 2018 Aug;13(6):600-608. doi: 10.1080/17483107.2017.1392619. Epub 2017 Oct 26. Review.

ReferenceCitation: Ciorba A, Bianchini C, Pelucchi S, Pastore A. The impact of hearing loss on the quality of life of elderly adults. Clin Interv Aging. 2012;7:159-63. doi: 10.2147/CIA.S26059. Epub 2012 Jun 15. Review.

ReferenceCitation: Ghulyan-Bédikian V, Paolino M, Giorgetti-D'Esclercs F, Paolino F. [Psychometric properties of a French adaptation of the Tinnitus Handicap Inventory]. Encephale. 2010 Oct;36(5):390-6. doi: 10.1016/j.encep.2009.12.007. Epub 2010 Jan 27. French.

ReferenceCitation: Gonthier C, Thomassin N, Roulin JL. The composite complex span: French validation of a short working memory task. Behav Res Methods. 2016 Mar;48(1):233-42. doi: 10.3758/s13428-015-0566-3.

ReferenceCitation: Jansen S, Luts H, Wagener KC, Kollmeier B, Del Rio M, Dauman R, James C, Fraysse B, Vormès E, Frachet B, Wouters J, van Wieringen A. Comparison of three types of French speech-in-noise tests: a multi-center study. Int J Audiol. 2012 Mar;51(3):164-73. doi: 10.3109/14992027.2011.633568. Epub 2011 Nov 28.

ReferenceCitation: Krueger M, Schulte M, Zokoll MA, Wagener KC, Meis M, Brand T, Holube I. Relation Between Listening Effort and Speech Intelligibility in Noise. Am J Audiol. 2017 Oct 12;26(3S):378-392. doi: 10.1044/2017_AJA-16-0136.

ReferenceCitation: Lakshmi MSK, Rout A, O'Donoghue CR. A systematic review and meta-analysis of digital noise reduction hearing aids in adults. Disabil Rehabil Assist Technol. 2021 Feb;16(2):120-129. doi: 10.1080/17483107.2019.1642394. Epub 2019 Sep 10.

ReferenceCitation: Livingston G, Sommerlad A, Orgeta V, Costafreda SG, Huntley J, Ames D, Ballard C, Banerjee S, Burns A, Cohen-Mansfield J, Cooper C, Fox N, Gitlin LN, Howard R, Kales HC, Larson EB, Ritchie K, Rockwood K, Sampson EL, Samus Q, Schneider LS, Selbæk G, Teri L, Mukadam N. Dementia prevention, intervention, and care. Lancet. 2017 Dec 16;390(10113):2673-2734. doi: 10.1016/S0140-6736(17)31363-6. Epub 2017 Jul 20. Review.

ReferenceCitation: Mener DJ, Betz J, Genther DJ, Chen D, Lin FR. Hearing loss and depression in older adults. J Am Geriatr Soc. 2013 Sep;61(9):1627-9. doi: 10.1111/jgs.12429.

ReferenceCitation: Mick P, Kawachi I, Lin FR. The association between hearing loss and social isolation in older adults. Otolaryngol Head Neck Surg. 2014 Mar;150(3):378-84. doi: 10.1177/0194599813518021. Epub 2014 Jan 2.

ReferenceCitation: Moore BC, Füllgrabe C, Stone MA. Determination of preferred parameters for multichannel compression using individually fitted simulated hearing AIDS and paired comparisons. Ear Hear. 2011 Sep-Oct;32(5):556-68. doi: 10.1097/AUD.0b013e31820b5f4c.

ReferenceCitation: Moulin A, Richard C. Sources of variability of speech, spatial, and qualities of hearing scale (SSQ) scores in normal-hearing and hearing-impaired populations. Int J Audiol. 2016;55(2):101-9. doi: 10.3109/14992027.2015.1104734. Epub 2015 Dec 1.

ReferenceCitation: Nasreddine ZS, Patel BB. Validation of Montreal Cognitive Assessment, MoCA, Alternate French Versions. Can J Neurol Sci. 2016 Sep;43(5):665-71. doi: 10.1017/cjn.2016.273.

ReferenceCitation: Neher T, Grimm G, Hohmann V, Kollmeier B. Do hearing loss and cognitive function modulate benefit from different binaural noise-reduction settings? Ear Hear. 2014 May-Jun;35(3):e52-62. doi: 10.1097/AUD.0000000000000003.

ReferenceCitation: Oldfield RC. The assessment and analysis of handedness: the Edinburgh inventory. Neuropsychologia. 1971 Mar;9(1):97-113.

lead_sponsor: Archean Technologies


title: Surfactant Replacement Guided by Early Lung Ultrasound Score (LUS) in Preterm Newborns < 33 Weeks With Respiratory Distress Syndrome in the Neonatal Intensive Care Unit of Saint-Etienne.

acronym: ECHOSURF

summary:
Lung immaturity is a major issue in neonatal unit.The surfactant administration improves the pulmonary prognosis in premature infants with hyaline membrane disease who escape continuous positive airway pressure (CPAP).

This surfactant had been administered at 5h25min of life in Saint Etienne from 2016 to 2019.

Studies suggest that the earlier the surfactant is administered, the more it can reduce the rate of bronchodysplasia and mortality. And some studies show a pulmonary ultrasound could help to administrate the surfactant earlier This is why a new faster strategy for diagnosing preterms needing surfactant will be usefulness and have been done in Saint-Etienne since 2021 thanks to a ultrasound score (LUS).

lead_sponsor: Centre Hospitalier Universitaire de Saint Etienne


title: Classical Monocyte Kinetics in Chronic Myelomonocytic Leukemia

acronym: MONOLIFE

summary: To measure the rate of bone marrow release and the lifespan of classical monocytes in the peripheral blood of patients with a chronic myelomonocytic leukemia


title: Etude Observationnelle de Cohorte Prospective évaluant Les bouffées de Chaleur Sur Deux Populations de Patientes : Population témoin et Patientes Sous hormonothérapie Adjuvante Pour un Cancer du Sein Hormonosensible

acronym: HOTSHOT

summary:
The validation of the HFRDIS questionnaire in French will allow the use in common practice of this questionnaire in consultation in order to have a concrete and reproducible assessment of the impact of hot flashes on the daily life of patients. This validation will also allow this questionnaire to be used in therapeutic trials to assess the effectiveness of a symptomatic treatment under study.

The use of this questionnaire in patients on hormone therapy will allow for an overall assessment of the impact of hot flashes in their daily lives.

There are no risks induced by participation in this research, it is only an observational study without change on the monitoring of participants in both cohorts.

lead_sponsor: Institut Curie


title: Randomized Pilot Study Evaluating the Effectiveness of Non-invasive Vagus Nerve Stimulation as an Adjuvant Treatment in Patients With Sepsis in Intensive Care.

acronym: SNV-Sepsis

summary: Sepsis is one of the leading causes of death in intensive care. About 50% of patients with septic shock die after 1 year; and 50% of survivors suffer from cognitive decline. The pathophysiological mechanisms of serious complications of sepsis are now well known. In fact, the systemic inflammation related to sepsis amplifies the release of pro-inflammatory cytokines and neurotoxic mediators, hence an increase in deleterious phenomena such as oxidative stress, mitochondrial dysfunction, endothelial activation, disruption of the blood-brain barrier, neuroinflammation (astrocytic and microglial activation) leading to multi-organ failure which compromises the patient's vital and functional prognosis. Although there has been progress in the understanding of its pathophysiology, the management of sepsis and septic shock in intensive care relies mainly on anti-infective treatments and the restoration of cardiovascular and respiratory functions. There is virtually no adjuvant therapy for the management of sepsis, apart from a few hormonal therapies such as insulin to maintain blood glucose levels below 180 mg / dL and low doses of corticosteroids and vasopressin. There is therefore a pressing need to develop innovative treatments targeting inflammatory and immunological processes in order to reduce the complications of sepsis and improve patient prognosis. Some recent work has shown that electrical vagus nerve stimulation (SNV), a technique used for the treatment of drug-resistant epilepsy, can modulate inflammatory and immune responses and control inflammation syndrome in animal models of sepsis, arthritis and rheumatism in humans. In this pilot study the investigators plan to evaluate the efficacy of transcutaneous (non-invasive) SNV as an adjuvant treatment in patients with sepsis in intensive care.


title: Pancytopenia Related to PARP Inhibitors in Cancer Patients : an Observational and Retrospective Study Using the WHO's Pharmacovigilance Database (PancytoRIB)

summary:
Although PARP inhibitors (PARPi) have proved effective in treating many cancers, few patients receiving PARPi may experience rare but serious adverse events such as pancytopenia. Today, data about pancytopenia are scarce.

The objective was to investigate reports of pancytopenia adverse events related to PARPi, including olaparib, rucaparib, niraparib, talazoparib, veliparib and pamiparib using the World Health Organization's (WHO) pharmacovigilance database: VigiBase.


title: Optimized C-arm Cone Beam CT (CBCT) in the Neuro Angio-suite (NAS) for the Endovascular Treatment (EVT) of Acute Ischemic and Hemorrhagic Stroke

acronym: ASO-AVC

summary: When it comes to acute stroke, everyone deserves the best care. Today, more patients can benefit from endovascular treatment (EVT) in a comprehensive stroke center. With the significant advances in C-arm Cone Beam CT (CBCT) imagings directly in the neuro angio-suite (NAS), the investigators are now able to identify, plan and treat stroke patients in the NAS, without the need for a separate CT scan. This provides valuable, time-saving support for critical patients in acute need of EVT. The main objective is to assess the diagnostic confidence of this optimized C-arm Cone Beam CT, named in french ASO, in the NAS for the detection of brain abnormalities and hemorrhagic complications for critical patients with acute stroke. The secondary objectives are to study the variability of the diagnostic accuracy concerning the staging of the stroke, the analysis of the brain vessel, the relevance of artefact reduction post treatment and the amount of dose for this ASO.

location_facility: service de Neuroradiologie interventionnelle NEURI - Hôpital Bicêtre


title: Pulmonary Toxicities With PARP Inhibitors in Cancer Patients: an Observational and Retrospective Study Using the WHO Pharmacovigilance Database (PulmonaRIB)

summary:
Although PARP inhibitors (PARPi) have proved effective in treating many cancers, few patients receiving PARPi may experience rare but serious (or not) adverse events such as pulmonary toxicities whose data are scarce.

The objective was to investigate reports of pulmonary toxicities related to PARPi, including olaparib, rucaparib, niraparib, talazoparib, veliparib and pamiparib using the World Health Organization's (WHO) pharmacovigilance database: VigiBase.


title: Study of Correlation Between Hepatic Fibrosis and Cardiovascular Risk Evaluated by Non-invasive Tests in Patients With Nonalcoholic Fatty Liver Disease

acronym: Cardio-NASH

summary: This study aims to examine the link between Non-Alcoholic Fatty Liver Disease (NAFLD) and cardiovascular diseases by studying the association between liver fibrosis degree and cardiovascular risk factors. The study would clarify the value and the role of the Coronary calcium score (CAC score) in the screening for coronary disease in this population at high cardiovascular risk.

lead_sponsor: Clinique Pasteur


title: Protocol in Reeducation Occupational Therapist in Coronary Patients

summary: The quality of life, linked to physical, social and mental performance in people with coronary heart disease represents the primary goals in terms of rehabilitation. This is often developed to meet the expected performance standard in order to give the person effective autonomy. However, is the occupational balance always evaluated? and this management adapted? Does occupational therapist, expert in autonomy and independence in multiple illnesses and disabilities, has a major role to play in cardiac rehabilitation? This area of expertise and the application of occupational therapy to coronary patients seems appropriate, if not necessary. However, there are few scientific studies on the need to include occupational therapy within cardiac rehabilitation protocols.


title: The Acceptability of a Real-time Localization of Patients and Caregivers

acronym: RTLS

summary: Technological innovations are taking over our daily lives, particularly in the health sector. Real-time location systems for healthcare professionals and patients are developing in hospitals. Today few studies have focused on the acceptability of this new technology. The present research, which aims to study the acceptability of a real-time localization systems, reveals a definite utility and acceptability from the patient's point of view, subject to conditions. Indeed, the guarantee of data security and the concrete interest for the patient must be explained. For healthcare professionals working in emergency departments, the usefulness of new technologies in their work is now well established. Nevertheless, the acceptability of a real-time location systems received lukewarm reviews. It depends mainly on reticence linked to the fear of a possible deviation in the use of the data collected.


title: Diagnostic Validity of a New Strategy for the Rapid Detection of Microorganisms and Their Resistance to Antibiotics Responsible for Pneumonia in Pediatric Intensive Care Units Using Protected Distal Samples

acronym: RAPSODI

summary: In patients with infectious pneumonitis, the FILMARRAY® Pneumonia Plus Panel technique (multiplex PCR) on a respiratory sample makes it possible to identify the responsible pathogen and its resistance to antibiotics in less than an hour and therefore to quickly adapt the anti- infectious. FILMARRAY® Pneumonia Plus has been validated on two types of specimens from adult intubated patients, tracheal aspirations and bronchoalveolar lavage. It has not been validated on protected distal samples which are nevertheless used in current practice. This project will study the diagnostic validity of this technique performed on this type of sample. If the validity is demonstrated, this will allow this technique to be used on the protected distal sample which is a reliable sample and used in the context of respiratory infections, in particular acquired under ventilation in children (bronchoalveolar lavage is less easy and little used in practice in children).


title: Genetics of Central Nervous System Arteriovenous Malformations (AVM): Genotype-Phenotype Correlation and Prognostic Impact on Patients With AVM

acronym: GENE-MAV

summary:
Cerebral and medullary arteriovenous malformations (AVMs) are morphologically abnormal vessels located on the surface or in the cerebral or medullary parenchyma. These vascular lesions cause the arterial and venous networks to communicate pathologically, creating an arteriovenous shunt.The prevalence of cerebral Cerebral and medullary AVMs in general population is difficult to establish given the rarity of the condition. However, it is estimated at around 1 per 10,000 inhabitants (0.01%). About 15-20% of the cerebral vascular accidents are asymptomatic at the time of diagnosis. The occurrence of intracranial haemorrhage is the most important prognostic factor because it is associated with a significant morbidity and mortality. The management of an AVM is usually carried out in a multidisciplinary way, combining interventional neuroradiology, neurosurgery and vascular neurology.

The genetic, molecular and cellular mechanisms that cause vascular malformations of the central nervous system are partially known. Several recent research works highlight mutations in the RAS-MAPK or MAPK-ERK signalling pathway in AVMs. In cases of cerebral AVMs considered to be sporadic, a somatic KRAS/BRAF mutation has recently been demonstrated in tissue samples of operated AVMs.

Except in the case of Hereditary Haemorrhagic Telangiectasia (HHT or Rendu-Osler-Weber syndrome), the influence of genetic damage on the prognosis of AVM is poorly known. It is also interesting to note that genetic screening is not routinely performed in patients with cerebro-medullary AVMs and that therefore the prevalence of these clinical entities in patients with AVMs is not known.

lead_sponsor: Fondation Ophtalmologique Adolphe de Rothschild

intervention_type: Genetic


title: Impact of Containment and the Current Epidemic on the Sexual Risk-taking of People Using PrEP to Prevent HIV Infection.

acronym: CoroPrEP

summary:
People using PrEP to prevent HIV infection have sexual risk-taking behaviors that motivated the prescription of PrEP. Both containment and the current epidemic may affect the sexual behavior of people using PrEP and the risk of acquiring STIs.

Hypotheses regarding the impact of the current epidemic-motivated confinement and its gradual lifting are as follows:

A decrease in sexual risk-taking during the confinement period, followed by an increase when the confinement is lifted.
An increase in sexual violence and the use of psychoactive substances.
An impact on PrEP monitoring and compliance.
An increase in the incidence of STIs when the confinement is lifted.

status: Active, not recruiting

lead_sponsor: Tourcoing Hospital


title: A Randomised, Double-blind, Three-arm, Parallel Group, Single-dose Study to Compare the Pharmacokinetics, Safety, Tolerability, and Immunogenicity of Ustekinumab (SB17, EU Sourced Stelara®, and US Sourced Stelara®) in Healthy Subjects

summary: This is a randomised, double-blind, three-arm, parallel group, single-dose study to evaluate the pharmacokinetics, safety, tolerability, and immunogenicity of SB17 compared to EU sourced Stelara® and US sourced Stelara® in healthy subjects

lead_sponsor: Samsung Bioepis Co., Ltd.


title: Evaluation of Tools to Assess Medication Adherence

summary:
The issue of medication adherence (MA) has long been undestimated but is now growing interest due to both the increase of patients with chronic diseases and the aging of the population. According to the World Health Organization, only 50% of patients with chronic illnesses correctly follow physician's prescriptions in developed countries. Beyond the individual consequences that failure to adherence can engender (increased morbidity, mortality and hospitalizations), this concept also encompasses a collective dimension (risk of transmission of infectious diseases and increased health care costs). Today, improving MA would have more impact on human health than developping new medical therapies. That's why detecting non-adherence constitutes a major public health issue in which pharmacists play a significant role through medication reconciliation and patients' education.

The methods wildly used are based on indirect measurement: questionnaires completed by the patient himself or the Medication Possession Ratio (MPR). Each method has its own advantages and disadvantages, but none is considered as the gold standard. The Montpellier University Hospital set up a MA self-report scale ranging from 0 (low) to 10 (high adherence) in the various care units where the clinical pharmacy activity is deployed.

The purpose of this study was to assess the MA according to this numerical scale and the MPR calculation, and evaluate the correlation between these two methods.

lead_sponsor: University Hospital, Montpellier


title: Characterization and Identification of Motor Parameters Using Instrumental Assessment in Patients With Limb Girdle Muscular Dystrophy

acronym: EIDY

summary:
The primary objective of the study is to perform 2-year follow up with motor parameters evolution using instrumental assessments in patients with limb girdle muscular dystrophie, and to identify which motor parameters are sensitive to change.

The secondary objectives of the study are:

to describe the changes of the parameters obtained from instrumental evaluations in comparison with the changes obtained from clinical assessments.
to characterize the muscular impairments, the biomechanical gait disorders, the standing postural control disorders, the biomechanical upper limb disorders in spatial exploration, the limitation of upper limb capacities, the fatigue, the endurance, the patients' participation to their activities and their quality of life, in comparison with a healthy paired population.
to highlight the relationships between muscular assessment parameters, biomechanical gait parameters, standing posture control and upper limb spatial exploration.
to highlight the relationships between data from instrumental assessments and data from clinical assessments.
to highlight the relationships between instrumental assessments data and clinical assessments data on one side, and features of patients (age, sex, duration since diagnosis, type of LGMD, rehabilitation in follow-up, sportive practices...) on the other side.

location_facility: Laboratoire d'analyse du mouvement, Service d'exploration fonctionnelles, Hôpital Raymond Poincaré, APHP


title: Correlation Between Head Perineum Distance Measured by Trans-périneal Ultrasound and Delivery Mode in Patient in the Second Stage of Labor

acronym: EchoPé

summary: In a prospective cohort of patients in the second phase of labor, the investigators measured the head-perineum distance and correlate it to the mode of delivery (spontaneous delivery - instrumental delivery - ceasarean section).

lead_sponsor: Rennes University Hospital

location_facility: Centre Hospitalier Universitaire de Rennes


title: Microendoscopic Transventricular Deep Brain Stimulation of the Anterior Nucleus of the Thalamus as a Safe and Efficient Treatment in Intractable Epilepsy

summary: Deep Brain Stimulation (DBS) of the anterior nucleus of the thalamus (ANT) has been proposed in patients with severe intractable epilepsy. When used, the transventricular approach increases the risk of bleeding due the anatomy around the entry point in the thalamus. To avoid such a complication, the investigators used a transventricular microendoscopic technique.


title: Impact of Non-fasting Strategy on Pre-operative Patients' Anxiety in Cataract Surgery Performed Under Topical Anesthesia

acronym: StarvAnx

summary: The aim of this prospective study was to investigate whether non-fasting recommendation could reduce preoperative anxiety level, incidence of anesthetist interventions, and number of surgical complications in elective cataract surgery patients.

ReferenceCitation: Chon T, Ma A, Mun-Price C. Perioperative Fasting and the Patient Experience. Cureus. 2017 May 24;9(5):e1272. doi: 10.7759/cureus.1272.

ReferenceCitation: Ogino Y, Kakeda T, Nakamura K, Saito S. Dehydration enhances pain-evoked activation in the human brain compared with rehydration. Anesth Analg. 2014 Jun;118(6):1317-25. doi: 10.1213/ANE.0b013e3182a9b028.

ReferenceCitation: Maltby JR, Hamilton RC. Preoperative fasting guidelines for cataract surgery under regional anaesthesia. Br J Anaesth. 1993 Jul;71(1):167.

ReferenceCitation: Steeds C, Mather SJ. Fasting regimens for regional ophthalmic anaesthesia. A survey of members of the British Ophthalmic Anaesthesia Society. Anaesthesia. 2001 Jul;56(7):638-42.

ReferenceCitation: Seet E, Kumar CM, Eke T, Joshi GP. Starving Patients Before Cataract Surgery Under Regional Anesthesia: Needed or Not? Anesth Analg. 2018 Dec;127(6):1448-1451. doi: 10.1213/ANE.0000000000003504.

location_facility: Service Anesthésie Réanimation chirurgicale, Hôpital Cochin


title: Use and Prescription of Beta-blockers Before Cardiac Surgery With Cardiopulmopnary Bypass: Multicenter Observational Analysis of Practices and Its Association With Postoperative Morbidity-mortality.

acronym: BLOCK

summary:
The objective of this study is to describe in a cohort of cardiac surgery patients the use of beta-blockers before surgery and their maintenance or withdraw according to international recommendations in order to compare patients who receive a beta-blocker with maintenance during the surgical period (international recommendation) to those for whom prescription and maintenance are not respected. Patients are treated according to standard practice and this protocol does not change patient management. No additional information or data is required by the study other than the data usually collected in the patient record (drug treatment, medical history, operating data, postoperative data, complications, length of stay).

The objectives of this research are :

To evaluate the proportion of patients receiving beta-blocker treatment prior to cardiac surgery.
To evaluate the proportion of patients receiving beta-blocker treatment before cardiac surgery and complying with international recommendations for its maintenance/stop in perioperative cardiac surgery.
To evaluate the incidence of complications and length of hospital stay in patients receiving beta-blockers based on compliance or non-compliance with recommendations.

status: Unknown status

lead_sponsor: Centre Hospitalier Universitaire Dijon

status_simplified: Unknown


title: Symbiotics and Systemic Inflammation in Chronic Kidney Disease

acronym: SISMIC

summary: Main objective: To assess the effectiveness of treatment with symbiotics on the chronic systemic inflammation observed in chronic renal failure 4 months after the start of treatment.

ipd_sharing_description: Individual data can be provided on request after validation by the competent regulatory authorities.

lead_sponsor: Centre Hospitalier Universitaire de Besancon


title: Pilot Study: the Links Between Basic Auditory Processes and High Functioning Cognitive Processes in Schizophrenia (Reality Monitoring and Emotional Perception)

acronym: AUDISPACE

summary:
Schizophrenia is a mental illness with a variety of clinical symptoms that can be regrouped into 2 categories: positive and negative symptoms.

This mental illness is also characterised by cognitive alterations in various fields, including social cognition difficulties and self / non-self-discrimination difficulties.

Self and non-self-discrimination abilities have been regrouped under a function called source memory. This source memory enables a person to identify the source of an information previously encoded. In our everyday life, these processes are necessary to distinguish events generated by an external source from imagined events. It is called reality monitoring.

A number of studies have evidenced reality-monitoring alterations in patients suffering from schizophrenia. More specifically, patients would present with an externalisation bias, they would assign more imagined events to an external source. The knowledge of these deficits encourages the study of the processes involved in order to better understand the alterations, particularly including auditory processes. A recent study has shown that discrimination errors concerning certain sound characteristics (e.g. frequency) were associated to reality monitoring errors. However, the links between reality-monitoring and basic auditory processes have rarely been explored.

The dysfunction of the auditory "where" path, especially the possibility to discriminate between the intra and extra cephalic localisation of sounds, could lead to difficulties to discern between what is produced by one self and what is produced by another or the local environment.

lead_sponsor: Hôpital le Vinatier


title: Left Ventricular Assist Device (LVAD) Versus Guideline Recommended Medical Therapy in Ambulatory Advanced Heart Failure Patients (GDMT)

acronym: AMBU-VAD

summary:
Heart failure is a severe disease affecting approximately 1-2% of the adult population in developed countries and around 26 million people worldwide. Up to 10% of these patients are in advanced stage heart failure, which is defined by a significant morbimortality and considerable medical expenses. Despite advances in its medical management, advanced (or end stage) heart failure is characterized by refractoriness to conventional therapies including guideline-directed pharmacological and non-surgical device treatments. These patients remain severely symptomatic (NYHA IV) and have objective signs of congestion or low cardiac output.

Left ventricular assist devices (LVADs) have been used in patients with heart failure with reduced ejection fraction for almost 20 years either as an alternative or a bridge to heart transplantation. LVADs improve heart failure symptoms and survival at the cost of increased rates of infection, stroke and bleeding.

Despite the lack of evidence, LVAD implantation in ambulatory patients is not rare, with INTERMACS profiles ≥4 patients representing 15.7% of the overall population implanted between 2012 and 2016.

The aim of this study is to investigate the efficacy and safety of left ventricular assist devices compared to traditional HF medical treatment alone in a population of ambulatory advanced heart failure patients. Secondary objectives are to better identify subgroups of patients that would benefit the most from the implantation of an LVAD as well as to assess the optimal timing of intervention.

lead_sponsor: Hospices Civils de Lyon


title: Non Inferiority Study of a Reduced Dose of Activated Charcoal on Rivaroxaban Pharmacokinetics.

summary: Rivaroxaban is a direct oral anticoagulant that target specifically activated factor X. Bleeding events related to rivaroxaban are the consequence of physiopathologic, pharmacokinetic issues or poisoning. A recent study, in healthy subjects, shows that activated charcoal can reduce significantly exposition to rivaroxaban. However, no results are available on the minimal dose of activated charcoal necessary in rivaroxaban poisoning. The objective of this study is to evaluate the effect of 4 dosing regimen activated charcoal on rivaroxaban pharmacokinetics. It corresponds to a randomised open trial with an incomplete cross over design (3 occasions). It will enrol 12 healthy subjects. Four treatments modalities will be studied: rivaroxaban with 50g, 24g, 12g and 6g of activated charcoal administrated 3 hours after rivaroxaban intake.


title: Evaluation of the Relationship Between the Duration of the Evolution of the Complex Regional Pain Syndrome Type 1 (CRPS 1) and Effectiveness of the Continuous Peripheral Nerve Block (CPNB) Associated With an Intensive Rehabilitation Program

acronym: BLOCALGO

summary:
The study evaluates the relationship between the duration of evolution of SDRC1 and the efficacy of continuous peripheral nerve block (c-PNB) associated with an intensive rehabilitation program to improve the therapeutic strategy of SDRC1.

The main hypothesis of this study is that if c-PNB is proposed earlier, the recovery, measured with a scale achievement of objectives, will be better.

lead_sponsor: Pôle Saint Hélier


title: Evaluation of the Efficiency and Complications Associated With the Surgical Treatment of Obesity by Laparoscopic Adjustable Gastric Banding in an Adolescent Population.

acronym: BariAdo

summary: Obesity affects 3%-4% of the pediatric population and leads to cardiac mortality during adult life. Bariatric surgery is the best treatment for weight loss and preventing obesity associated comorbidities in adults, but its applications and safety are yet to be defined for adolescents.

lead_sponsor: University Hospital, Angers


title: Netrin-1 in Hepatocellular Carcinoma: Pathology, Preclinical Targeting, and Definition of Eligibility Criteria for Phase 1 Trials

acronym: HCC-Net

summary: Netrin-1 is a dependence receptor ligand participating in the pathology of several cancer types. It is up-regulated in chronic liver diseases, cirrhosis and HCC. We hypothesize that netrin-1 may play a detrimental role in HCC. The goal of this project is to characterize netrin-1 signals in HCC samples with ad hoc controls, to investigate the benefit of capturing netrin-1 in preclinical models of HCC and to try to define patients groups the most likely to benefit from this targeting approach in the clinic.

location_facility: Hepatogastroenterology service of the Croix-Rousse Hospital


title: Study Evaluating the Bonds Between Circulating Tumoral ADN (ctDNA) and the Development of Peritoneal Carcinomatosis for Patients Treated With PIPAC

acronym: PIPADN

summary:
PIPADN is a pilot monocentric, study with a total duration of 42 months. The purpose of this study is to describe the variation of plasma ctDNA concentration between the 1st and the 3rd PIPAC session in patients with peritoneal carcinomatosis.

The improvement of life quality with this type of treatment will also be evaluated though the EORTC QLQ-C30 survey.

Each patient will have three PIPAC sessions spaced 6 to 8 weeks apart. Two blood samples will be taken during the first 3 PIPAC sessions, one the day before each procedure and a second one 24 hours afterwards.

The EORTC QLQ 30 survey will be completed by patients during the pre-operative consultation and at each post-operative consultation (about 3 weeks after PIPAC sessions).

lead_sponsor: Institut de Cancérologie de Lorraine


title: Type 2 Diabetes and Bone Microarchitecture in Men and Women: a Case-control Study

summary:
Type 2 diabetes is a major public health problem, associated with an increased risk of fractures. Diabetes even appears to be the most important predictor of low kinetic fractures in men and women, and the risk of hip fracture in type 2 diabetics is increased by 40 to 50%, with often more serious consequences (post-operative complications, longer hospital stays, increased mortality rate).

Currently, the risk of fractures is estimated by the measure of areal bone mineral density (aBMD) and T-score. However, in diabetics aBMD is not decreased, and even paradoxically increased. Indeed, aBMD is 5-10% higher in type 2 diabetic patients compared to non-diabetic subjects, which suggests that the assessment of fracture risk in these patients is underestimated. The High Resolution peripheral Quantitative Computed Tomography (HR-pQCT) 3D bone imaging technique has a resolution close to the size of the bone trabeculae. It is used to assess volumetric bone mineral density (vBMD) and bone microarchitecture at the tibia and distal radius, and enables a better estimation of the fracture risk compared to the measurement of aBMD. Our hypothesis is that bone microarchitecture is altered in type 2 diabetic patients, explaining the increased risk of fracture in this population compared to non-diabetics.

We propose to set up a descriptive case control study, nestled in 3 cohorts of men and women (QUALYOR, OFELY and STRAMBO), to compare the bone micro-architecture measured by HR-pQCT at the level of the tibia and distal radius, in type 2 diabetics compared to non-diabetic subjects from the same cohorts.

location_facility: INSERM U1033, pavillon F, Hôpital E. Herriot. 5, place d'Arsonval


title: Reliability of the Clinical Dementia Rating Scale From the Medical Record in Comparison With the Reference Method.

acronym: CLIMER

summary:
The assessment of severity of the cognitive and functional impairment is essential in the follow-up of patients with neurocognitive disorders and in the assessment of the effectiveness of therapeutics. However, the systematic assessment of the Clinical Dementia Rating (CDR) scale is limited due to the time required to complete it (approximately 45 min to 1 hour). Insofar as studies have shown correspondences between the CDR and scales measuring cognitive and neuropsychological performance, and as part of memory consultations, several functional and neuropsychological scales are systematically administered, we wish to conduct a study validating the feasibility of the CDR based on information already available in the patient's file compared to the evaluation of the CDR by the usual method (face-to-face interview in consultation).

This study should highlight the feasibility of scoring the CDR-SB from the files of patients in memory consultation, first in terms of reliability of the scores obtained compared to the standard evaluation, and on the other hand in terms of organization and duration of administration.