title: Integrative Study of Physiological Changes Induced by a 5-Day Dry Immersion, Used as a Ground-based Model to Mimic Weightlessness: a Pilot Study on 20 Healthy Female Volunteers (DI5-Women Study)

summary:
Dry immersion (DI) is a ground-based model of prolonged conditions of simulated microgravity. Dry immersion involves immersing the subject in water covered with an elastic waterproof fabric. As a result, the immersed subject, who is freely suspended in the water mass, remains dry. Within a relatively short duration, the model can faithfully reproduce most physiological effects of actual microgravity, including centralization of body fluids, support unloading, and hypokinesia.

The objective of the study is to evaluate the physiological changes induced by 5 days of dry immersion in the female organism. The main physiological systems will be explored before, during and after the 5 days of immersion through a battery of specific tests and measurements. The results will be analyzed by scientists specializing in each field in order to better understand the dry immersion model, to compare its effects with those of the bedrest model and those of spaceflight. The clinical (adverse effects, comfort of subjects) and operational aspects are also part of the secondary objectives of the study.

ReferenceCitation: Navasiolava NM, Custaud MA, Tomilovskaya ES, Larina IM, Mano T, Gauquelin-Koch G, Gharib C, Kozlovskaya IB. Long-term dry immersion: review and prospects. Eur J Appl Physiol. 2011 Jul;111(7):1235-60. doi: 10.1007/s00421-010-1750-x. Epub 2010 Dec 14. Review.

ReferenceCitation: De Abreu S, Amirova L, Murphy R, Wallace R, Twomey L, Gauquelin-Koch G, Raverot V, Larcher F, Custaud MA, Navasiolava N. Multi-System Deconditioning in 3-Day Dry Immersion without Daily Raise. Front Physiol. 2017 Oct 13;8:799. doi: 10.3389/fphys.2017.00799. eCollection 2017.

ReferenceCitation: Kermorgant M, Leca F, Nasr N, Custaud MA, Geeraerts T, Czosnyka M, Arvanitis DN, Senard JM, Pavy-Le Traon A. Impacts of Simulated Weightlessness by Dry Immersion on Optic Nerve Sheath Diameter and Cerebral Autoregulation. Front Physiol. 2017 Oct 12;8:780. doi: 10.3389/fphys.2017.00780. eCollection 2017.

ReferenceCitation: Linossier MT, Amirova LE, Thomas M, Normand M, Bareille MP, Gauquelin-Koch G, Beck A, Costes-Salon MC, Bonneau C, Gharib C, Custaud MA, Vico L. Effects of short-term dry immersion on bone remodeling markers, insulin and adipokines. PLoS One. 2017 Aug 14;12(8):e0182970. doi: 10.1371/journal.pone.0182970. eCollection 2017.

lead_sponsor: Centre National d'Etudes Spatiales


type: Other Identifier

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.

study_start_date_type: Actual

status: Recruiting

study_completion_date_type: Anticipated

study_type: Interventional

design_allocation: Non-Randomized

primary_purpose: Other

enrollment_type: Anticipated

ipd_sharing: No

lead_sponsor: Assistance Publique - Hôpitaux de Paris

intervention_type: Other

lead_sponsor_type: academique

status_simplified: Ongoing


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.

study_type: Observational

time_perspective: Other

ipd_sharing: Undecided

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.

study_start_date_type: Anticipated

status: Not yet recruiting

primary_purpose: Basic Science

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.

time_perspective: Prospective

ipd_sharing_description: NC

lead_sponsor: University Hospital, Montpellier


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

lead_sponsor: Poitiers University Hospital


title: AQUA: A NEW QUESTIONNAIRE ASSESSING ANTICHOLINERGIC SIDE EFFECTS IN NEUROGENIC POPULATION (AQUA: Anticholinergic Side Effects QUestionnAire)

acronym: AQUA

summary:
Lower Urinary tract symptoms (LUTS) are widespread in the general population and their prevalence is expected to increase in the coming years as the elderly population increases. Indeed, overactive bladder syndrome (OAB) is very frequent and increase with age. OAB has numerous and various etiologies and can be caused by urologic, metabolic, neurogenic or autonomic dysfunction. Treatments for OAB depends on etiology but first line treatment often corresponds to lifestyle modification and antimuscarinics. Antimuscarinics allows improvement for OAB symptoms, quality of life and urodynamic parameters. However, antimuscarinics adherence is poor and anticholinergic drugs are often withdrawn few months after their introduction. This low adherence to antimuscarinics can be explained by side effects as dry mouth, blurred vision, constipation or cognitive impairment which are due to systemic anticholinergic effects since specificity and receptor affinity of bladder antimuscarinics are poor with a large distribution of acetylcholine receptors in all the body. Unfortunately, there is no or a few questionnaires which evaluate side effects or constraints, except for one published in 2019, but not specific for anticholinergics. This part of evaluation is poorly reported in medical literature, whereas it seems to be clear that side effects should be systematically evaluate and are in part responsible of treatment discontinuation. The objective of the study is to develop and validate a new questionnaire to assess side effects of antimuscarinic treatment in a patient with OAB.

The study was conducted in a Neuro-urology Department of a University Hospital. To allow a full psychometric validation of the questionnaire, the study protocol included 3 steps: qualitative interviews, feasibility study and validation study. The inclusion criteria were to be aged > 18 years and to have OAB symptoms according to the ICS definition and secondary to a neurogenic dysfunction.

First step of the study consisted in a review literature on Pubmed to explore the different side effects secondary to antimuscarinic treatment and do determine which tools were available. In addition, we conducted semi-structured interviews on 30 patients suffering from OAB.

Feasibility Study For this feasibility study, 30 patients were included. They had to rate each item to evaluate comprehension, acceptation and pertinence with a three-points Likert scale from response "0: not at all or quite" to "2: perfectly".

Validation study: 100 patients Content validity was assessed by the panel of experts. Internal consistency reliability was calculated using the α coefficient of Cronbach. Each response has been transformed in a numeric value to perform this test. Alpha coefficient of Cronbach was considered as very good if > 0.7.

Test-retest reliability was tested using the intraclass correlation coefficient (ICC) which was significant over 0.7. The first questionnaire was filled at the end of the first consultation and patients had to answer a second questionnaire (filled at home) 7 days after the first consultation.

Objective was to validate this questionnaire with good or very good psychometric properties. Primary outcome was Alpha coefficient of Cronbach and ICC ≥ 0,7.

lead_sponsor: Pierre and Marie Curie University

location_facility: department of Neuro-Urology, Hôpital Tenon


title: Evaluation of the Impact of the Administration of Single Dose of Ivermectin in the Early Phase of COVID-19 on the Time to Negativation of the SARS-COV-2 Viral Load Determinated by RT-PCR

acronym: IVERCoV

summary:
The action of ivermectin in vitro on the viral replication of SARS-CoV-2 was demonstrated and published by an Australian team in June 2020. On the other hand, the doses to be administered in vivo to reach the concentrations described in vitro would lead to toxicities especially neurological, in treated patients, . However, some trials and studies, such as the ICON3 study, demonstrate the clinical efficacy of ivermectin administered at lower doses (200 µg / kg) in hospitalized patients with COVID-19.

The use of ivermectin in the early stages of the disease has not yet been studied. The administration of the maximum authorized dose (MA) of ivermectin could at least slow down the replication of the virus in vivo before the inflammatory phase of COVID-19, and reduce the duration of symptoms as well as the risk of hospitalization of patients, especially in critical care.

Unlike other studies conducted so far on COVID-19, IVERCoV will target the "viral" phase of the disease by screening patients in the city. In addition, home visits (symptom recording +/- PCR) will make it easier to monitor patients during the study.

status: Active, not recruiting

design_allocation: Randomized

primary_purpose: Treatment

lead_sponsor: Raincy Montfermeil Hospital Group

intervention_type: Drug


title: Monitoring Mitophagy In Myeloid Cells Upon Intensive Care

acronym: MIMIC

summary:
Severe infections (sepsis) are a frequent cause of admission to the intensive care unit. Sepsis represent a significant risk for the health of patients in the short and medium term. Sepsis are notably linked to a change in the function of immune cells. In some patients, a state of pseudo-dormancy of monocyte and macrophage immune cells, called myeloid cell immunosuppression, is observed. This situation, which leads to a worsening of the infection, must be avoided because it represents a danger for the patient, even during antibiotic therapy. At present, these events are still very poorly understood. Research is needed to understand how the immunosuppression of myeloid cells occurs in order to adapt existing treatments or to find new ones.

Laboratory work on animal models of sepsis has shown that this state of myeloid cell immunosuppression is closely linked to a modification of energy production by myeloid cells (monocytes and macrophages). The function of the mitochondria ("energy factory" of the cells) in these cells is impaired. Thus, restoring mitochondrial function in myeloid cells could be a therapeutic solution against the immunosuppression of myeloid cells during severe sepsis.

The aim of this study is to verify whether alterations in mitochondrial function in myeloid cells occur in both patients with and without bacterial infection.

lead_sponsor: Centre Hospitalier Universitaire Dijon


title: Comparison of Azathioprine to Methotrexate in Combination Therapy With Adalimumab in Crohn's Disease: an Open-label Randomized Controlled Trial

acronym: COMET

summary:
Combination therapy, the association of an anti-Tumor Necrosis Factor (TNF) to an immunosuppressant, is recognized as the most effective treatment during Crohn's disease (CD). Several mechanisms have been proposed to explain the superiority of combination therapy over monotherapy, the additive effect of two effective drugs or the prevention of anti-TNF immunogenicity. As the best combination therapy is unknown, both azathioprine (AZA) and methotrexate (MTX) are used. Some retrospective studies suggest a higher effectiveness of AZA. MTX may have an advantage in terms of safety.

The investigators hypothesize that AZA is more effective than MTX as combination therapy with adalimumab to improve short-term endoscopic, clinical and pharmacological outcomes in CD patients.

lead_sponsor: Centre Hospitalier Universitaire, Amiens


title: Neurologic and Immunologic Characteristics of CTLA-4 and LRBA Hereditary Deficiency

summary: CTLA4 and LRBA deficiencies are rare genetic disorders, recently described, and associated with multiple clinical features. It ranges from recurrent infections, auto-immunity, and organ infiltration with lymphocytes. Neurologic syndroms are described in up to 30% of patients, yet they are poorly defined to date. Early recognition of a specific pattern can be important, given that there is a targeted therapy in this situation.

status: Completed

study_completion_date_type: Actual

time_perspective: Retrospective

enrollment_type: Actual

ReferenceType: result

ReferenceCitation: Schindler MK, Pittaluga S, Enose-Akahata Y, Su HC, Rao VK, Rump A, Jacobson S, Cortese I, Reich DS, Uzel G. Haploinsufficiency of immune checkpoint receptor CTLA4 induces a distinct neuroinflammatory disorder. J Clin Invest. 2020 Oct 1;130(10):5551-5561. doi: 10.1172/JCI135947.

family: Schindler

full_name: Matthew K. Schindler

given: Matthew K.

sequence: first

family: Pittaluga

full_name: Stefania Pittaluga

given: Stefania

sequence: additional

family: Enose-Akahata

full_name: Yoshimi Enose-Akahata

given: Yoshimi

family: Su

full_name: Helen C. Su

given: Helen C.

family: Rao

full_name: V. Koneti Rao

given: V. Koneti

family: Rump

full_name: Amy Rump

given: Amy

family: Jacobson

full_name: Steven Jacobson

given: Steven

family: Cortese

full_name: Irene Cortese

given: Irene

family: Reich

full_name: Daniel S. Reich

given: Daniel S.

family: Uzel

full_name: Gulbu Uzel

given: Gulbu

bso_classification: Medical research

datasource: user

genre: journal-article

genre_raw: journal-article

journal_name: Journal of Clinical Investigation

oa_colors: green hybrid

oa_host_type: publisher;repository

evidence: open (via free pdf)

host_type: publisher

license_normalized: no license

version: publishedVersion

evidence: oa repository (via pmcid lookup)

host_type: repository

repository_normalized: PubMed Central

publisher: American Society for Clinical Investigation

ReferenceCitation: Ayrignac X, Goulabchand R, Jeziorski E, Rullier P, Carra-Dallière C, Lozano C, Portales P, Vincent T, Viallard JF, Menjot de Champfleur N, Rieux-Laucat F, Besnard C, Koenig M, Guissart C, Labauge P, Guilpain P. Two neurologic facets of CTLA4-related haploinsufficiency. Neurol Neuroimmunol Neuroinflamm. 2020 Jun 4;7(4). pii: e751. doi: 10.1212/NXI.0000000000000751. Print 2020 Jul.

family: Ayrignac

full_name: Xavier Ayrignac

given: Xavier

family: Goulabchand

full_name: Radjiv Goulabchand

given: Radjiv

family: Jeziorski

full_name: Eric Jeziorski

given: Eric

family: Rullier

full_name: Patricia Rullier

given: Patricia

family: Carra-Dallière

full_name: Clarissa Carra-Dallière

given: Clarissa

family: Lozano

full_name: Claire Lozano

given: Claire

family: Portales

full_name: Pierre Portales

given: Pierre

family: Vincent

full_name: Thierry Vincent

given: Thierry

family: Viallard

full_name: Jean François Viallard

given: Jean François

journal_name: Neurology - Neuroimmunology Neuroinflammation

publisher: Ovid Technologies (Wolters Kluwer Health)

ReferenceCitation: Schubert D, Bode C, Kenefeck R, Hou TZ, Wing JB, Kennedy A, Bulashevska A, Petersen BS, Schäffer AA, Grüning BA, Unger S, Frede N, Baumann U, Witte T, Schmidt RE, Dueckers G, Niehues T, Seneviratne S, Kanariou M, Speckmann C, Ehl S, Rensing-Ehl A, Warnatz K, Rakhmanov M, Thimme R, Hasselblatt P, Emmerich F, Cathomen T, Backofen R, Fisch P, Seidl M, May A, Schmitt-Graeff A, Ikemizu S, Salzer U, Franke A, Sakaguchi S, Walker LSK, Sansom DM, Grimbacher B. Autosomal dominant immune dysregulation syndrome in humans with CTLA4 mutations. Nat Med. 2014 Dec;20(12):1410-1416. doi: 10.1038/nm.3746. Epub 2014 Oct 20.


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).

primary_purpose: Diagnostic

lead_sponsor: E-Scopics

intervention_type: Device

lead_sponsor_type: industriel


title: A Comparative Study Between Malone Procedure and Percutaneaous Endoscopic Caecostomy in Patients Treated With Antegrade Colonic Enema for Severe Anal Incontinence and/or Constipation

acronym: MAPEC

summary:
Background: Antegrade colonic enema (ACE) is a second intent treatment of severe constipation and/or fecal incontinence following the failure of medical treatment. ACE is classically administered through a percutaneous access to the caecum performed surgically according to the Malone procedure (MP). Recently, a novel endoscopic approach named Percutaneous Endoscopic Caecostomy (PEC) has been proposed to perform the percutaneous access to the caecum. PEC has never been compared to the traditional MP in terms of postoperative quality of life and functional outcomes.

Objective: The aim of the study is to compare postoperative quality of life between MP and PEC in patients treated with ACE for severe constipation and/or fecal incontinence.

Hypothesis: MP and PEC achieve similar quality of life outcomes. Methods: All patients from two prospective databases who underwent MP or PEC for severe constipation and/or fecal incontinence between 2006 and 2016 will be included. They will be contacted to answer questionnaires about quality of life (GIQLI) and functional outcomes including constipation, fecal incontinence and body image assessment (KESS, Wexner and BIQ scores respectively). The main measured outcome will be GIQLI score.

Results: The results of this comparative study will determine if the endoscopic and the surgical approaches are similar in terms of quality of life, or if one of them is better than the other. This study will clarify the optimal protocol to perform a caecal percutaneous access before ACE administration in patients suffering from severe constipation and/or fecal incontinence.

lead_sponsor: Nantes University Hospital

status_simplified: Completed


title: Observational Single-center Study of the Relationship Between Arterial Hypertension and Hypervolemia Defined by Self-measurement of Impedancemetry in Kidney Transplant Patients With Transplantation Less Than 3 Months Old

acronym: HTAôConnect

summary:
The working hypothesis is that hypertension during the first post-transplant trimester is partly explained by the patient's hypervolemia. The main objective of the single-center observational study "HTA ô Connect" is to study the relationship between hypertension and extracellular hyperhydration, thanks to repeated self-measurements of blood pressure and impedancemetry between the 30th and the 90th day post-transplant, in 150 incident kidney transplant patients from our department, the ITUN (Institute of Urology-Nephrology Transplantation).

The study population involves 150 incident kidney transplant patients, presenting to the Nantes University Hospital Transplant Institute for 1 month (D30), and presenting with hypertension ≥ 140/90mmHg and not treated with a diuretic.

Data collected at the patients' homes will be used to establish a relationship between blood pressure and extracellular water volume. The data collected will not be used to follow up patients who participated in the study in this first stage of exploration.


title: Efficacy at One Year of Combined Injections of Plasma Rich in Platelets and Hyaluronic Acid in Knee Osteoarthritis

acronym: ISPAG

summary: The French Society of Rheumatology cannot rule on the value of intra-articular injections of PRP due to the lack of hindsight and insufficient data. In fact, the injection protocols are very heterogeneous in terms of preparation method, the presence or not of leukocytes, the number of centrifugations, the volume injected, the ultrasound guidance, which makes it difficult to analyze the literature. The investigator objective is therefore to evaluate the effectiveness of combined injections of PRP and hyaluronic acid.


title: Biobank for Inflammatory Chronic Diseases and Osteoporosis of TOULouse

acronym: BIOTOUL

summary: The aim of this study is to constitute a biobank for patients followed in the Rheumatology center of Toulouse University Hospital for a chronic inflammatory rheumatism including rheumatoid arthritis (RA), spondyloarthritis(SpA), and psoriatic arthritis (PsA) or a chronic bone disease including osteoporosis in order to identify biomarkers associated with therapeutic response.

lead_sponsor: University Hospital, Toulouse

intervention_type: Biological


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)


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

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.

time_perspective: Cross-Sectional

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.

primary_purpose: Supportive Care


title: Observational Study on the Efficacy and Tolerance of EYEBRID Lenses

acronym: EYEBRID

summary:
Technical advances in lenses are continuous and materials are improved. We provide a prospective longitudinal observational study evaluating the efficacy and safety of new EyeBrid Excel hybrid lenses (LCS) in the treatment of severe ametropia and for patients with corneal irregularities.

This study should include 60 patients for a period of three months. The aim of this work is to assess the improvement in the best corrected visual acuity and the good tolerance of this lens.

lead_sponsor: University Hospital, Caen


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.

intervention_type: Diagnostic Test


title: Assessment of Patients' Pain and Anxiety During a Hysterosalpingography Narratified by a Virtual Reality Helmet.

acronym: Daphné

summary: Compare the maximum pain and anxiety experienced between the group using a virtual reality headset and the control group in an adult woman during a hysterosalpingography examination


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.


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

lead_sponsor: Gustave Roussy, Cancer Campus, Grand Paris


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: Impact of Compression Garments on Neuropathic-looking Pain in Patients With Complex Regional Pain Syndrome (CRPS) of the Upper Limbs.

acronym: VECODON

summary: The aim is to study another alternative for the treatment of pain in people with CRPS. Indeed, the TRAB / Medullary occupational therapy department of the CMRRF in Kerpape used compression garments to reduce edema when it was present.In the case of CRPS of the upper limbs, gloves or compression sleeves are used to decrease the edema which is sometimes associated, although they are not supported for this indication. In this context, our clinical experience leads us to believe that there would also be some efficacy in neuropathic pain, this improvement being regularly described by patients.This study is expected to show a notable reduction in neuropathic pain thanks to the wearing of a compression garment.

lead_sponsor: Centre Mutualiste de Rééducation et de Réadaptation Fonctionnelles de Kerpape


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.


type: EudraCT Number

title: Efficacy of the Application of Xylocaine Impregnated Compress in Reducing Per-procedural Pain During Ultrasound-guided Infiltration of Trigger Finger: a Randomized, Double-blind Controlled Study (SAUTYLO)

acronym: SAUTYLO

summary: The purpose of this study is to assess the efficacy of Xylocaine impregnated compress in reducing per-procedural pain during ultrasound-guided infiltration of Trigger Finger

lead_sponsor: Assistance Publique - Hôpitaux de Paris


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: Follow-up of Children With Severe Asthma at Adult Age

summary:
Most of clinical cohorts focused on the course of asthma over time and on the different phenotypes of asthma have investigated children and adults separately. The passage from childhood to adulthood is scarcely explored.

In this context, we decided to explore the course of asthma severity from teenage to adulthood in children with severe asthma. The secondary objectives are to assess the quality of life and socioeconomic status in adulthood.

This study will be both retrospective (data collected during childhood) and prospective (data collected during adulthood), multicentric and observational


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: Trace Elements Concentration in Dialysis

acronym: EMTDialyse

summary:
In hemodialysis population the study team finds high concentrations of toxic trace elements (2 times higher than the general population for cadmium 4 to 13 times for lead). Several recent studies suggest a role of chronic exposure to cadmium in the loss of residual renal function, osteoporosis, graft failure, arteriosclerosis, as well as in excess cardiovascular mortality.

Moreover, in hemodialysis population, a deficit of certain essential trace elements (manganese, selenium, zinc) is observed. For example, in the population undergoing chronic hemodialysis, a zinc deficiency is found in 40 to 78% of cases. Zinc is a cofactor of more than 70 enzymes.

In this observational cohort, the study team seeks to understand the impact of HD and HDF on the serum concentrations of heavy metals and also oligometals, by studying their concentrations in the dialysate during dialysis sessions by inductive coupled plasma mass-spectrometry (ICP-MS).

ReferenceType: background

ReferenceCitation: Tonelli M, Wiebe N, Bello A, Field CJ, Gill JS, Hemmelgarn BR, Holmes DT, Jindal K, Klarenbach SW, Manns BJ, Thadhani R, Kinniburgh D; Alberta Kidney Disease Network. Concentrations of Trace Elements in Hemodialysis Patients: A Prospective Cohort Study. Am J Kidney Dis. 2017 Nov;70(5):696-704. doi: 10.1053/j.ajkd.2017.06.029. Epub 2017 Aug 31.

ReferenceCitation: Prodanchuk M, Makarov O, Pisarev E, Sheiman B, Kulyzkiy M. Disturbances of trace element metabolism in ESRD patients receiving hemodialysis and hemodiafiltration. Cent European J Urol. 2014;66(4):472-6. doi: 10.5173/ceju.2013.04.art23. Epub 2014 Jan 27.

ReferenceCitation: Orr SE, Bridges CC. Chronic Kidney Disease and Exposure to Nephrotoxic Metals. Int J Mol Sci. 2017 May 12;18(5). pii: E1039. doi: 10.3390/ijms18051039. Review.

ReferenceCitation: Messner B, Knoflach M, Seubert A, Ritsch A, Pfaller K, Henderson B, Shen YH, Zeller I, Willeit J, Laufer G, Wick G, Kiechl S, Bernhard D. Cadmium is a novel and independent risk factor for early atherosclerosis mechanisms and in vivo relevance. Arterioscler Thromb Vasc Biol. 2009 Sep;29(9):1392-8. doi: 10.1161/ATVBAHA.109.190082. Epub 2009 Jun 25.

ReferenceCitation: Lee CC, Weng CH, Huang WH, Yen TH, Lin JL, Lin-Tan DT, Chen KH, Hsu CW. Association Between Blood Cadmium Levels and Mortality in Peritoneal Dialysis. Medicine (Baltimore). 2016 May;95(19):e3717. doi: 10.1097/MD.0000000000003717.

ReferenceCitation: Sotomayor CG, Groothof D, Vodegel JJ, Eisenga MF, Knobbe TJ, IJmker J, Lammerts RGM, de Borst MH, Berger SP, Nolte IM, Rodrigo R, Slart RHJA, Navis GJ, Touw DJ, Bakker SJL. Plasma cadmium is associated with increased risk of long-term kidney graft failure. Kidney Int. 2021 May;99(5):1213-1224. doi: 10.1016/j.kint.2020.08.027. Epub 2020 Sep 14.

ReferenceCitation: Larsson SC, Wolk A. Urinary cadmium and mortality from all causes, cancer and cardiovascular disease in the general population: systematic review and meta-analysis of cohort studies. Int J Epidemiol. 2016 Jun;45(3):782-91. doi: 10.1093/ije/dyv086. Epub 2015 May 20. Review.

ReferenceCitation: Satarug S, C Gobe G, A Vesey D, Phelps KR. Cadmium and Lead Exposure, Nephrotoxicity, and Mortality. Toxics. 2020 Oct 13;8(4). pii: E86. doi: 10.3390/toxics8040086. Review.

ReferenceCitation: Roozbeh J, Sharifian M, Sagheb MM, Shabani S, Hamidian Jahromi A, Afshariani R, Pakfetrat M, Salehi O. Comment on: does zinc supplementation affect inflammatory markers in hemodialysis patients? Ren Fail. 2011;33(4):466-7. doi: 10.3109/0886022X.2011.568144.


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.

lead_sponsor: Tourcoing Hospital


title: Effects of Long-term Remote Health Monitoring Through Bright Light Exposure, Physical Adapted Activity and Galvanic Vestibular Stimulation on the Sleep of the Elderly: Study Protocol for a Randomised Controlled Trial

acronym: velocce

summary: This study investigates the effects of remote interventions based on the exposure to one or more zeitgebers (i.e. adapted physical activity alone or combined with bright light exposure, or galvanic vestibular stimulation) performed several times a week during three months on older adults' sleep and quality of life.

lead_sponsor: Université de Caen Normandie

intervention_type: Behavioral


title: Evaluation of MEpolizumab-based Regimen Compared to Conventional Therapeutic Strategy For Remission Induction In Patients With Eosinophilic Granulomatosis With Polyangiitis. Prospective, Randomized, Controlled, Double-blind Study

acronym: E-merge

summary: The purpose of this study is to compare mepolizumab-based regimen to conventional therapeutic strategy for remission induction in patients with Eosinophilic Granulomatosis with Polyangiitis.

location_facility: Service de Médecine Interne, Centre de référence " Maladies systémiques et autoimmunes rares, en particulier Vascularites nécrosantes et Sclérodermies systémiques "Hôpital Cochin


title: Study of Variations of Immune Infiltrate and Cell Plasticity Markers in Patients With Metastatic Melanoma Under Treatment

acronym: COLEMAN

summary:
COLEMAN is an opened prospective monocentric non-randomized study, initiated by the Hospices Civils de Lyon. Population targeted are patients from 18 years old with stage III or IV metastatic melanoma eligible for a metastatic melanoma treatment administered as part of usual care.

The objective is to study the variations of immune infiltrate and cell plasticity before and under immunotherapy or targeted therapy. Two biopsies are done before and one month after the treatment initiation and one blood sample is done after the treatment initiation.

100 patients will be included and followed during 5 years.

lead_sponsor: Hospices Civils de Lyon


type: Registry Identifier

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: Single-center Retrospective Study on Safety of Total Knee Replacement Surgery Before and After the Implementation of Enhanced Recovery Program

summary: The objectives are to describe the transition from traditional care to an enhanced recovery program for the management of total knee arthroplasty, and to evaluate the effect on patient outcomes.

ipd_sharing: Yes

ipd_sharing_description:
Data will be made available with publication. Keywords are Arthroplasty, Replacement, Knee, Enhanced Recovery After Surgery. The available version will be the locked database. The database will be made available by the study director upon request up to 15 years after publication. Medical Subject Headings (MESH) terms will be used to describe clinical data.

Methodology for will be provided in the publication. International standard unit will be used.

lead_sponsor: Groupe Hospitalier de la Rochelle Ré Aunis


title: A Phase 1, Open-Label Study to Assess the Pharmacokinetics, and Safety and Tolerability of a Single Intravenous Injection of rFVIIIFc-VWF-XTEN (BIVV001) in Adults With Type 2N and 3 Von Willebrand Disease (VWD)

summary:
Primary Objective:

-To characterize the pharmacokinetics (PK) of BIVV001 after a single intravenous (IV) administration, as assessed by factor VIII (FVIII) activity determined by the one-stage activated partial thromboplastin time (aPPT) clotting assay, as well as, BIVV001 capture chromogenic Coatest FVIII activity assay

Secondary Objective:

-To assess the safety and tolerability of a single IV dose of BIVV001 in adult patients with type 2N and 3 VWD

ipd_sharing_description: Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://www.clinicalstudydatarequest.com/

lead_sponsor: Bioverativ, a Sanofi company


title: Preliminary Descriptive Exploratory Pilot Study Research of Circulating Tumor Cells Released During Cervical Cancer Surgery

acronym: C-CTC

summary:
Cervical cancer is a rare pathology. Recent studies showed that the risk of recurrence is higher for patients treated by coelioscopy in comparison with laparotomy. It could be explained by the spread of circulating tumor cells (CTC) due to tumor mobilization during coelioscopy.

The primary goal is to evaluate the spread of CTC during surgery on peripheral blood samples.

The secondary outcome is to evaluation the disease-free survival at 3 and 5 years postoperatively.

20 patients with early stage cervical (IA1 to IB2) eligible to coelioscopic surgery will be included.

primary_purpose: Prevention

lead_sponsor: University Hospital, Montpellier

location_facility: Department of gynaecology, Montpellier University Hospital


title: Exploring the Psycho-traumatic Impact of a Violent Act Commited - Study Among Inmates of the Bordeaux-Gradignan Penitentiary Center

acronym: IPTAVC

summary: The study will seek to explore the possibility of developing post-traumatic stress disorder following a violent offense commited, among the population of prisoners of the Bordeaux-Gradignan penitentiary center.

ReferenceCitation: Koenen KC, Ratanatharathorn A, Ng L, McLaughlin KA, Bromet EJ, Stein DJ, Karam EG, Meron Ruscio A, Benjet C, Scott K, Atwoli L, Petukhova M, Lim CCW, Aguilar-Gaxiola S, Al-Hamzawi A, Alonso J, Bunting B, Ciutan M, de Girolamo G, Degenhardt L, Gureje O, Haro JM, Huang Y, Kawakami N, Lee S, Navarro-Mateu F, Pennell BE, Piazza M, Sampson N, Ten Have M, Torres Y, Viana MC, Williams D, Xavier M, Kessler RC. Posttraumatic stress disorder in the World Mental Health Surveys. Psychol Med. 2017 Oct;47(13):2260-2274. doi: 10.1017/S0033291717000708. Epub 2017 Apr 7.

ReferenceCitation: Baranyi G, Cassidy M, Fazel S, Priebe S, Mundt AP. Prevalence of Posttraumatic Stress Disorder in Prisoners. Epidemiol Rev. 2018 Jun 1;40(1):134-145. doi: 10.1093/epirev/mxx015. Erratum in: Epidemiol Rev. 2018 Jun 1;40(1):166.

ReferenceCitation: Ashbaugh AR, Houle-Johnson S, Herbert C, El-Hage W, Brunet A. Psychometric Validation of the English and French Versions of the Posttraumatic Stress Disorder Checklist for DSM-5 (PCL-5). PLoS One. 2016 Oct 10;11(10):e0161645. doi: 10.1371/journal.pone.0161645. eCollection 2016.

ReferenceCitation: Jakobowitz S, Bebbington P, McKenzie N, Iveson R, Duffield G, Kerr M, Killaspy H. Assessing needs for psychiatric treatment in prisoners: 2. Met and unmet need. Soc Psychiatry Psychiatr Epidemiol. 2017 Feb;52(2):231-240. doi: 10.1007/s00127-016-1313-5. Epub 2016 Nov 22.

ReferenceCitation: Vaiva G, Jehel L, Cottencin O, Ducrocq F, Duchet C, Omnes C, Genest P, Rouillon F, Roelandt JL. [Prevalence of trauma-related disorders in the French WHO study: Santé mentale en population générale (SMPG)]. Encephale. 2008 Dec;34(6):577-83. doi: 10.1016/j.encep.2007.11.006. Epub 2008 Apr 2. French.

ipd_sharing_description: no IPD sharing plan

lead_sponsor: Centre Hospitalier Charles Perrens, Bordeaux


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.

lead_sponsor: Centre Hospitalier Universitaire Dijon


title: Measurement of Brain Perfusion by a Magnetic Resonance (MR) Perfusion Imaging Called eASL in Children's Cerebral Arteriopathies.

acronym: PEACE

summary:
The MR sequence called MR-ASL is used to measure cerebral perfusion in children. This ASL sequence is used with a unique post-labeling delay (PLD) due to the technical impossibility of setting different post-labeling delays. The use of a single post-labeling, chosen by the pediatric radiology department of the Necker hospital, optimal in children without arteriopathy, may not be suitable for the lengthened arterial transit time of the spins marked in the pathological carotid network of a child with arterial disease.

Recently, ASL sequences with multiple delays (multi-PLD, called eASL) have been developed to overcome this limitation in arterial disease. To date, their use in the pre- and post-treatment evaluation of a child with acute or chronic arterial disease has not been evaluated.

The study hypothesis is that this eASL sequence is more efficient than single-delay ASL in measuring cerebral perfusion. The study will be performed in a population of children with acute or chronic arterial disease.


title: BKVIR Project: Predictive Biological Method of BKvirus Associated Nephropathy Risk by the NEPHROVIR Method

acronym: BK-VIR

summary:
BKvirus associated nephropathy (BKvAN) is a major complication in kidney transplantation. Due to BKvirus (BKv) intra-graft replication, BKvAN affects nearly 10% of patients and causes graft loss in more than 50% of cases. Without current antiviral therapy, the treatment consists of minimizing immunosuppression, secondarily exposing the patient to a graft rejection risk. Impaired BKv specific T cell response plays a crucial role in the BKvAN pathophysiology. Several teams, including ours, have demonstrated a profound impairment of BKv specific T cell response during BKvAN. Immunovirological monitoring allows an individual assessment of viral reactivation risk based on the anti-viral immune response. Our group has developed the NEPHROVIR method. This non-invasive biological method for BKvAN allows the identification of BKvAN risk level. The aim of this work is to evaluate, by the NEPHROVIR method, the risk to develop a BKvAN with renal impairment in kidney transplant recipients with sustained BKv viremia.

The investigators propose the BKVIR study. This is a prospective multicentric study involving 100 kidney transplant recipients with sustained BKv viremia. The aim of this work is to evaluate the NEPHROVIR method as an innovative immunovirological surveillance method for predicting the risk of BKvAN occurrence. The characterization of individual BKvAN risk level could help in the individualized follow-up and management of immunosuppression in patients. The long-term objective would be to diagnose very early, or even anticipate, the occurrence of BKvAN and to allow early readjustment of the immunosuppressive treatment.


title: Evaluation of the Incidence of NTRK Gene Fusion in Adult Brain Tumours

acronym: NTRK Fusion

summary: This is a retrospective, mono centric, exploratory study to assess the incidence of a genomic alteration: NTRK gene fusion, in adult gliomas and brain metastases.

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


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.

location_facility: Hôpital Pneumologique et Cardiovasculaire Louis Pradel


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: Non-invasive Prenatal Testing of Placental Chromosomal Abnormalities in Fetus With Intrauterine Growth Restriction

acronym: DPNI-RCIU

summary:
The objective of this project is the non-invasive prenatal detection of placenta-limited aneuploidies, in patients whose fetuses have a intrauterine growth restriction below 3rd percentile, in parallel with an amniocentesis.

This study will allow the chromosomal study of the placenta in pregnant women whose genetic prenatal diagnosis, made by amniocentesis, does not allow exploring the placental causes of fetal RCIU.

lead_sponsor: University Hospital, Bordeaux

location_facility: Centre Hospitalier Universitaire de Bordeaux


title: Interest of Bilateral Basic Tongue Mucosectomy Assisted by Robot or Laser in Combination With Tonsillectomy in the Assessment of Prevalent Cervical Lymphadenopathy: a Randomized Phase II Study

acronym: RoboCUP

summary: We are proposing a randomized phase II study to assess the benefit of bilateral robot-assisted or laser basal tongue mucosectomy in combination with tonsillectomy in the assessment of prevalent cervical lymphadenopathy

lead_sponsor: Centre Francois Baclesse


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: Impact of Osteopathic Manipulative Treatment on External Lateral Ocular Pursuit, Measured in Healthy Human Adults: a Randomized, Double-blind, Controlled Study

summary: The idea that osteopathic manipulative treatments (OMTs) should have an impact on the human visual system is not new. Nevertheless, there is a lack of scientific, objective, and experimental evidence. Our goal is to conduct a randomized, double-blind, controlled study to evaluate the effect of OMT on ocular pursuit. Eye movements will be measured by an infra-red video-based eye tracking system with a high spatial and temporal resolution. OMTs will be similar to regular treatments given by osteopaths in their daily practice. We hypothesize that OMT will improve the quality of ocular pursuit.

ReferenceCitation: Bordoni B, Zanier E. Clinical and symptomatological reflections: the fascial system. J Multidiscip Healthc. 2014 Sep 18;7:401-11. doi: 10.2147/JMDH.S68308. eCollection 2014.

lead_sponsor: Ecole d'ostéopathie de Paris


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.


title: TOcilizumab and Covid-19 : Risk of Severe INfection

acronym: TOCSIN

summary: SARS-CoV2 is responsible for a pandemic that has been evolving for approximately 18 months. The virus' capacity for dissemination and its virulence are responsible for significant morbidity and mortality. The initial lack of knowledge of the pathogen and of the pathophysiology underlying the potential severity of the disease, particularly in the respiratory tract, led to numerous therapeutic attempts in this emergency context, centered on the control of an obviously exaggerated inflammatory response. A large number of studies remained of insufficient quality to lead to relevant and applicable conclusions. Secondly, the benefit of corticosteroid therapy has been demonstrated in two trials. Although Dexamethasone remains the only corticosteroid to improve survival, these results have reinforced the hypothesis of the interest of treatments reducing the inflammatory response, particularly cytokine. The widespread use, in the absence of scientific data, of interleukin-6 receptor inhibitors (Sarilumab and Tocilizumab) has been structured around studies whose results remain uncertain to this day because of the heterogeneity of the population treated and the results observed. A possible survival benefit seems to emerge for resuscitation patients who have not yet required invasive ventilation, the other situations being probably associated with the absence of effect or even the potential danger of this treatment. Tocilizumab is notably associated in the literature with the risk of secondary infections and mucosal healing abnormalities, favoring bleeding complications and digestive perforations. The objective of this study is to evaluate the risk of digestive complications (hemorrhage, perforation, diverticulitis) and infectious complications related to the use of Tocilizumab according to the severity of the patients.

ReferenceCitation: Birgand G, Peiffer-Smadja N, Fournier S, Kerneis S, Lescure FX, Lucet JC. Assessment of Air Contamination by SARS-CoV-2 in Hospital Settings. JAMA Netw Open. 2020 Dec 1;3(12):e2033232. doi: 10.1001/jamanetworkopen.2020.33232. Erratum in: JAMA Netw Open. 2021 Jan 4;4(1):e2037904.

ReferenceCitation: Ong SWX, Tan YK, Chia PY, Lee TH, Ng OT, Wong MSY, Marimuthu K. Air, Surface Environmental, and Personal Protective Equipment Contamination by Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) From a Symptomatic Patient. JAMA. 2020 Apr 28;323(16):1610-1612. doi: 10.1001/jama.2020.3227.

ReferenceCitation: Leung NHL. Transmissibility and transmission of respiratory viruses. Nat Rev Microbiol. 2021 Aug;19(8):528-545. doi: 10.1038/s41579-021-00535-6. Epub 2021 Mar 22. Review.

ReferenceCitation: KENDALL EJ, BYNOE ML, TYRRELL DA. Virus isolations from common colds occurring in a residential school. Br Med J. 1962 Jul 14;2(5297):82-6.

ReferenceCitation: Yin Y, Wunderink RG. MERS, SARS and other coronaviruses as causes of pneumonia. Respirology. 2018 Feb;23(2):130-137. doi: 10.1111/resp.13196. Epub 2017 Oct 20. Review.

name: Department of Infectious Diseases and Clinical Microbiology; Beijing Chao-Yang Hospital, Capital Medical University; Beijing China

family: Yin

full_name: Yudong Yin

given: Yudong

name: Division of Pulmonary and Critical Care, Department of Medicine; Northwestern University Feinberg School of Medicine; Chicago Illinois USA

family: Wunderink

full_name: Richard G. Wunderink

given: Richard G.

journal_name: Respirology

evidence: open (via free article)

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

license: implied-oa

license_normalized: implied-oa

repository_institution: PubMed Central - Europe PMC

publisher: Wiley

publisher_dissemination: Wiley

publisher_group: Wiley

publisher_normalized: Wiley

ReferenceCitation: Wu Z, McGoogan JM. Characteristics of and Important Lessons From the Coronavirus Disease 2019 (COVID-19) Outbreak in China: Summary of a Report of 72 314 Cases From the Chinese Center for Disease Control and Prevention. JAMA. 2020 Apr 7;323(13):1239-1242. doi: 10.1001/jama.2020.2648.

name: Chinese Center for Disease Control and Prevention, Beijing, China

family: Wu

full_name: Zunyou Wu

given: Zunyou

family: McGoogan

full_name: Jennifer M. McGoogan

given: Jennifer M.

journal_name: JAMA

oa_host_type: publisher

publisher: American Medical Association (AMA)

publisher_dissemination: American Medical Association

publisher_group: American Medical Association

publisher_normalized: American Medical Association

lead_sponsor: Groupe Hospitalier Paris Saint Joseph


title: Effectiveness and Safety of JAK Inhibitors for the Treatment of Moderate-to-severe Atopic Dermatitis in a Real-life French Multicenter Adult Cohort

acronym: JAKIGREAT

summary: The aim is to assess effectiveness (EASI, SCORAD, IGA, DLQI, pruritus, sleep loss) and safety (clinical and biological adverse events) of JAK inhibitors in adults with moderate-to-severe atopic dermatitis in a real-life French multicenter retrospective cohort

status: Enrolling by invitation

lead_sponsor: University Hospital, Lille

status_simplified: Unknown


title: Prevalence and Factors Associated With Insomnia and Sleep Time in a Sample of Professional Flight Members

acronym: SOMNAVI

summary: Sleep is a physiological function that plays an essential role in many somatic, cognitive or psychological processes. Although the criteria for sleep effectiveness are multiple, its quantity is unanimously recognized as a major determinant of health. Too little sleep time is indeed associated with an increase in metabolic, cardiovascular and accidental morbidity and mortality, caused by sleepiness during journeys or at the workplace. In the wake of recent work in the general French population, a specific study on the prevalence and factors associated with sleeping time and chronic insomnia among flight members appears relevant. Chronic insomnia and sleep debt can thus be assumed to be more common among aircrews than in the general population, due to these specific operational constraints. Better consideration of certain sleep disorders in professional flight members could make it possible to adapt prevention or countermeasures strategies intended to optimize risk management with regard to flight safety.

lead_sponsor: Direction Centrale du Service de Santé des Armées


title: Study for the Quantification in Ecological Conditions of Sensorimotor and Dysexecutive Disorders in Cerebral Palsy Patients

summary:
Executive functions are defined as the mental functions necessary for an individual to adapt to a complex or new environment that requires freedom from automatic and routine behavior. Deficits in executive functions are described under the term "dysexecutive syndrome", and call into question the quality of social and professional life as well as the autonomy of patients.

The usual methods of identifying dysexecutive syndrome are based essentially on batteries of neuropsychological tests known as "paper and pencil". However, these tests may lack sensitivity, in that they assess the patient in a very structured setting, very different from real life conditions, which are full of distractions and choices to be made.

Evaluations on real tasks are more rarely used but have the advantage of observing the difficulties encountered by a patient in everyday life.

Two tests of this type have been set up in the Neurology Department of the Hôpital d'Instruction des Armées Percy, and are integrated into the routine care of patients with a dysexecutive syndrome.

For this purpose, a room in the department has been set up as a studio in order to reproduce as much as possible an everyday life environment, in which executive functions, fine motor skills, neurovegetative functions, emotional state, posture, locomotor skills and visual information capture can be measured ecologically.


title: Multicenter Observational Study Evaluating the Performance and Safety of Use of the "KONTACT PERIO LEVEL" Dental Implant in Routine Clinical Practice.

acronym: KPL

summary: As part of post-marketing clinical follow-up, BIOTECH DENTAL sets up the collection and evaluation of clinical data proactively with the aim of confirming the safety, performance as well as the constantly acceptable nature of the risks identified and of detecting potential emerging risks with the use of "Kontact Perio Level" implants in everyday practice.

lead_sponsor: Biotech Dental


title: Multicenter Observational Study on Performance and Safety Use of "KONTACT MB" Dental Implant in Daily Practice

summary:
A multicenter prospective observational study aims to illustrate the clinical outcome of dental implants "Kontact MB" and the effects of its Mono Block design on the peri implant bone tissue recession and soft tissue conservation.

All the enrolled patients will be eligible for one or multiple implant-supported fixed restoration(s) according to the routine clinical practice and the manufacturer's instruction for use.


title: Characteristics of Patients With Disruptive Vocalizations Residing in Nursing Homes Supported by the Mobile Gerontopsychiatry Team : Retrospective Study

summary:
Patients with dementia develop behavioral problems over time. Among these, the investigators object screams or cries or disruptives vocalizations. Their cause is multifactorial and their management difficult in nursing homes. Often this patients are polymedicated, sedated or/and isolated.

Many scientific studies are interested in drug and non-drug treatments. In this study, the investigators are looking for a profile for disruptives vocalizations's patients. Thus, the investigators will study the global profile of demented patients residing in EHPAD to determine if there are any similarities between them.


title: Benefits of a Music-based Self-relaxing Program Application (MUSIC-CARE) Combined to Locoregional Anesthesia for Forearm Orthopedic Surgery : A Randomized Trial

summary:
Anxiety, fright, stress and pain have always been sources of emotional distress for patients undergoing invasive procedures in clinical settings. Experts have long used traditional methods such as analgesics and anxiolytics to address these issues. But, backed by a movement aiming at reducing the use of pharmacological products, alternative interventions, including music therapy, have gained some steam in recent years. These interventions may have the ability to reduce pain and anxiety while increasing relaxation, coping skills and the overall experience of the procedure. For orthopedic surgery, anesthetics could propose general anesthesia or locoregional anesthesia. The upper limb orthopedic surgery is often performed under locoregional anesthesia and in the ambulatory procedure. However, with the known exacerbating effects of stress and anxiety on pain, the affective experience of the patient can be negatively influenced. In order to mitigate these problems, various types of sedatives and anxiolytics and even low-dose propofol can be used.

The Montpellier Regional University Hospital, along with the Music Care Company developed a software so as to standardize this technique around these recommendations. This model demonstrated its efficacy in both acute and chronic pain settings. Indeed, a single music therapy session was found to be effective for decreasing anxiety and promoting relaxation, as indicated by decreases in heart rate, blood pressure, BIS and respiratory rate over the intervention period in intubated patients during weaning phase. Also, a patient-controlled music intervention administered by Music Care has shown to alleviate negative psychological (e.g., depression) and physiological (e.g., pain and discomfort) outcomes and, very importantly, to reduce the consumption of medication in patients with chronic pain due to lumbar pain, fibromyalgia, inflammatory or neurological diseases.

Given the recent availability of a standardized and proven delivery method of music therapy (i.e. MUSIC-CARE), the principal aim of this randomized clinical trial is to assess the effect of this music therapy program delivered by application compared to usual playlist music on drug consumptions and physiological parameters, pain, anxiety levels in patients undergoing forearm orthopedic surgery under locoregional anesthesia.

ReferenceCitation: Hole J, Hirsch M, Ball E, Meads C. Music as an aid for postoperative recovery in adults: a systematic review and meta-analysis. Lancet. 2015 Oct 24;386(10004):1659-71. doi: 10.1016/S0140-6736(15)60169-6. Epub 2015 Aug 12. Review. Erratum in: Lancet. 2015 Oct 24;386(10004):1630.

ReferenceCitation: Guétin S, Giniès P, Siou DK, Picot MC, Pommié C, Guldner E, Gosp AM, Ostyn K, Coudeyre E, Touchon J. The effects of music intervention in the management of chronic pain: a single-blind, randomized, controlled trial. Clin J Pain. 2012 May;28(4):329-37. doi: 10.1097/AJP.0b013e31822be973.

family: Guétin

full_name: Stéphane Guétin

given: Stéphane

family: Giniès

full_name: Patrick Giniès

given: Patrick

family: Siou

full_name: Didier Kong A. Siou

given: Didier Kong A.

family: Picot

full_name: Marie-Christine Picot

given: Marie-Christine

family: Pommié

full_name: Christelle Pommié

given: Christelle

family: Guldner

full_name: Elisabeth Guldner

given: Elisabeth

family: Gosp

full_name: Anne-Marie Gosp

given: Anne-Marie

family: Ostyn

full_name: Katelyne Ostyn

given: Katelyne

family: Coudeyre

full_name: Emmanuel Coudeyre

given: Emmanuel

family: Touchon

full_name: Jacques Touchon

given: Jacques

journal_name: The Clinical Journal of Pain

publisher_dissemination: Wolters Kluwer Health

publisher_group: Wolters Kluwer Health

publisher_normalized: Wolters Kluwer Health

title: The Effects of Music Intervention in the Management of Chronic Pain

ReferenceCitation: Graff V, Cai L, Badiola I, Elkassabany NM. Music versus midazolam during preoperative nerve block placements: a prospective randomized controlled study. Reg Anesth Pain Med. 2019 Jul 18. pii: rapm-2018-100251. doi: 10.1136/rapm-2018-100251. [Epub ahead of print]

ReferenceCitation: Fu VX, Oomens P, Sneiders D, van den Berg SAA, Feelders RA, Wijnhoven BPL, Jeekel J. The Effect of Perioperative Music on the Stress Response to Surgery: A Meta-analysis. J Surg Res. 2019 Dec;244:444-455. doi: 10.1016/j.jss.2019.06.052. Epub 2019 Jul 18.

ReferenceCitation: Zengin S, Kabul S, Al B, Sarcan E, Doğan M, Yildirim C. Effects of music therapy on pain and anxiety in patients undergoing port catheter placement procedure. Complement Ther Med. 2013 Dec;21(6):689-96. doi: 10.1016/j.ctim.2013.08.017. Epub 2013 Sep 1.

lead_sponsor: American Hospital of Paris


title: Effect of VIrtual Reality Spectacles on the Management of Pain and Anxiety During the Insertion of the Implantable Catheter Chamber in the Operating Theatre in Cancer Patients

acronym: LURVIDOC

summary: To assess the contribution of the use of virtual reality glasses on the pain perceived by patients during the installation of an ICP in the operating room under local anesthesia in the patient newly diagnosed with cancer

lead_sponsor: Poissy-Saint Germain Hospital


title: Impact of Von Willebrand Factor-platelet Aggregates in Patients With Type 2B Disease

summary: The working hypothesis is that patients with Von Willebrand Disease-type 2B may have neurological symptoms due to the chronic formation of platelets/Von Willebrand Factor aggregates. Interestingly, several patients present nonspecific neurological symptoms (nystagmus, headaches, memory disorder, …) which may be associated with cerebral microangiopathy and chronic microvessel inflammation secondary to Von Willebrand Disease-type 2B due to chronic exposure to Von Willebrand Factor-platelets complexes.

lead_sponsor: University Hospital, Caen


title: Evaluation of the Clinical and Radiological Outcome of Uncemented Femoral Stems According to Their Proximal Coating.

acronym: ETNA

summary:
Evaluation of the clinical and radiological outcome of uncemented femoral stems according to their proximal coating.

Retrospective study


title: Evaluation of an Enhanced Recovery Protocol After Minimally Invasive Lumbar Surgery.

acronym: ERAMIS

summary:
Prospective longitudinal multicentre observational study carried out on a population of patients undergoing minimally invasive spine surgery and divided into two parallel cohorts according to the presence or absence of a Enhanced Recovery After Surgery (ERAS) programme.

The patient will be assessed during 4 visits: At inclusion before surgery, at D0 (day of surgery), at D1 (postoperative visit) and at M1 (follow-up visit).


title: Evaluation of Noise Induced by Ceramic-ceramic Friction Torques of Total Hip Prostheses With Customized Femoral Stem

acronym: ATHENS

summary:
Evaluation of noise induced by ceramic-ceramic friction torques of total hip prostheses with customized femoral stem.

Retrospective and prospective multicentric study.


title: Sprint Interval Training (SIT) on the Endurance, Strength and Velocity Capacities of Healthy Sedentary Subjects

acronym: BénéfiSIT

summary: The present study aims to analyse first, the acute effects generated by a single bout of Sprint Interval Training (SIT) and, secondly, the effects of a long-term intervention on sedentary participants.

lead_sponsor: Centre Hospitalier Universitaire de Saint Etienne


title: Effects of Manipulating Swimming Speed and Frequency on Swimming Economy in High-level Swimmers and Para-swimmers

summary: The competitive swimming and open water swimming events are scheduled for the 2024 Paris Olympic and Paralympian Games. Generally associated with a non-neglectable number of medals in the last Olympics, swimming performance depends on the swimmer's ability to manage his or her Stroke Length and Stroke Rate, where Velocity can be defined as the product of SR and SL. The optimisation of this management depends on the swimmer's ability to develop a large motor repertoire and to use the coordination mode (catch-up, opposition, superposition) best suited to the environmental constraints and opponents' adversity. These adaptations may contribute to 1) a modification of the energy expenditure or be dependent on the energy supply necessary for muscular contraction and 2) the preferential use of one or other of the metabolic pathways in the production of this chemical energy, moreover in an aquatic environment inducing particular thermal exchanges.

ReferenceCitation: Thompson KG, Haljand R, MacLaren DP. An analysis of selected kinematic variables in national and elite male and female 100-m and 200-m breaststroke swimmers. J Sports Sci. 2000 Jun;18(6):421-31.

ReferenceCitation: Thompson KG, MacLaren DP, Lees A, Atkinson G. The effects of changing pace on metabolism and stroke characteristics during high-speed breaststroke swimming. J Sports Sci. 2004 Feb;22(2):149-57.

ReferenceCitation: Seifert L, Chollet D, Rouard A. Swimming constraints and arm coordination. Hum Mov Sci. 2007 Feb;26(1):68-86. Epub 2006 Nov 28.

ReferenceCitation: Seifert L, Komar J, Crettenand F, Millet G. Coordination pattern adaptability: energy cost of degenerate behaviors. PLoS One. 2014 Sep 25;9(9):e107839. doi: 10.1371/journal.pone.0107839. eCollection 2014.

ReferenceCitation: Seifert L, Komar J, Araújo D, Davids K. Neurobiological degeneracy: A key property for functional adaptations of perception and action to constraints. Neurosci Biobehav Rev. 2016 Oct;69:159-65. doi: 10.1016/j.neubiorev.2016.08.006. Epub 2016 Aug 6. Review.

ReferenceCitation: Ribeiro J, Toubekis AG, Figueiredo P, de Jesus K, Toussaint HM, Alves F, Vilas-Boas JP, Fernandes RJ. Biophysical Determinants of Front-Crawl Swimming at Moderate and Severe Intensities. Int J Sports Physiol Perform. 2017 Feb;12(2):241-246. doi: 10.1123/ijspp.2015-0766. Epub 2016 Aug 24.

lead_sponsor: University of Rouen Normandie

location_facility: Institut National du Sport, de l'Expertise et de la Performance


title: Assessment of the Feasibility of Using a Smartphone Application for the Prevention and Screening of Burnout

acronym: BURNOUT ADVICE

summary:
Burnout syndrome has been recognized as a mental illness since 2020. All workers can be affected. The consequences are multiple and often serious, ranging from stoppage of work to depression or even suicide. According to a 2019 survey by Malakoff, 56% of employees are in "professional or personal fragility", but the statistics are incomplete.

In the medical community, the burnout rate is doubled compared to the general population.

The diagnosis of pre-burnout can precede a burnout by several months, an early treatment can then reduce complications and improve the quality of life at work.

On a study model on health data already carried out as part of a cancer detection application in smokers which involved 7000 users and which showed the ability to of such an application to detect curable symptomatic cancers from questionnaires (24% with application against 9% without application), we will carry out a descriptive evaluation of the use of an application to detect pre-burnout, burnout and depressive syndrome in a worker population. In the event of a risk alert of pre-burnout, burnout or depressive syndrome, the application will display a message to the user suggesting that he consult his general practitioner or put him in contact with a doctor through a teleconsultation via a dedicated platform.

This first study will assess the feasibility and acceptability of an early detection approach among professionals of a state of "fragility" (pre-burnout, burnout or depressive syndrome). Subsequently, a larger study will evaluate the effectiveness of this application for the early detection of burnout among professionals, its management and the reduction of costs for the healthcare system and society.

lead_sponsor: Weprom


title: Evolution of Protective Immunization Against SARS-CoV-2 Among Hospital Workers in Health Care Facilities

acronym: ICONE

summary: To measure the immunization rate (seroneutralization) in a population of exposed hospital workers (nursing staff assigned to dedicated COVID-19 care units, laboratory staff handling COVID-19 samples).

lead_sponsor: Assistance Publique Hopitaux De Marseille

location_facility: Assistance Publique Des Hopitaux de Marseille


title: Controlled Study of Immunogenicity and Safety of the Investigational vYF Candidate Vaccine in Comparison to Stamaril in Adults

summary:
VYF03 is a phase II, randomized, parallel-group prevention study with 2 arms, active-controlled (Stamaril), observer-blind, multi-center study to assess the non-inferiority of the immune response, in terms of seroconversion rates of the investigational vaccine candidate vYF to the licensed Stamaril, in adults aged 18 years up to 60 years in Europe (EU).

The safety and immunogenicity profile of vYF in a cohort of Asian population of Chinese origin outside of China will also be described. The study will also assess the immunogenicity profiles and the safety profiles of vYF and Stamaril.

Participants will be randomized in a 2:1 ratio to receive a single subcutaneous injection of either the vYF vaccine (380 participants in EU and 80 participants of Chinese origin in Asia) or Stamaril (190 participants in EU and 40 participants of Chinese origin in Asia), on Day 01.

The duration of each participant's participation will be approximately 5 years.

lead_sponsor: Sanofi Pasteur, a Sanofi Company


title: Evaluation of the Effects of Bradykinin Antagonists on Pulmonary Manifestations of COVID-19 Infections (AntagoBrad-Cov Study).

acronym: AntagoBrad-Cov

summary: The main objective of this study is to evaluate the efficacy of human C1 inhibitor, administered alone or in combination with icatibant (a specific bradykinin B2 receptor antagonist) on the pulmonary manifestations of COVID-19 infections.

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


title: Evaluation of Factors Associated With Return to Sports Activity Six Months After Anterior Shoulder Stabilisation With Latarjet.

acronym: ERASME

summary:
On a population of sports patients who had undergone a Latarjet operation for post-traumatic anterior shoulder instability, reviewed in consultation 6 months after the operation as part of an ordinary follow-up and divided into two groups according to their current sports practice.

Group 1: "SUCCESS": return to the same level in the same sport. Group 2: "FAILURE": return to the same sport with a reduced level or change of sport or significant reduction or cessation of sporting activity.


title: Is Routine Postoperative Oxygen Therapy Still Necessary in 2020?

summary: The purpose of this study by automated control of oxygen supply in the immediate postoperative period is to show the possibility of immediate weaning in the postoperative period in case of remifentanil use and complete reversion of curarization.

lead_sponsor: Hopital Foch


title: CD160 Ans Corneal Graft: Expression in Corneal Vessels

summary: Despite improvements in corneal transplantation, anti-angiogenic and anti-lymphangiogenic factors remain to be be identified. CD160 is an anti-angiogenic target: its expression seems to be restricted to some immune cells and to activated endothelial cells. We hypothesized that CD160 is expressed in blood and lymphatic human corneal neovessels and is involved in corneal graft rejection pathogenesis

lead_sponsor: CHU de Reims


title: Evaluation of Functional Outcomes at 2 Months According to Therapeutic Management, in Trauma With Low-grade Osteo-ligamentous Ankle Injury in Children

acronym: CHEVIPED

summary:
Lack of current consensus on the therapeutic management of low-grade osteo-ligament injuries in ankle trauma in children. Several types of immobilization are evaluated in the literature, with different conclusions. Some teams recommend a functional treatment similar to the adult (with or without strict immobilization), others remain on standard rigid immobilizations.

The goal of the study is to simplify and homogenize the therapeutic management of low-grade osteo-ligament injuries in ankle trauma in children.

ipd_sharing_description: All collected data that underlie results in a publication

lead_sponsor: University Hospital, Brest


title: Effect of Botulinum Toxin on Hamstring Contracture and the Occurrence of Cyclops Syndrome After Anterior Cruciate Ligament Reconstruction

acronym: SCALA

summary:
Monocentric, prospective, randomised, double-blind study of two parallel groups of 66 patients with post-reconstruction ACL hamstring contracture treated with an ultrasound-guided injection at two points on the body of the hamstring

Group 1: botulinum toxin: 100 units (0.5ml) in 1 injection
Group 2: placebo: 0.5 ml in 1 injection


title: Validation in French of a Psychometric Tool for Measuring Health Literacy in the Field of Cancer

acronym: CaLiS

summary: Validation in French of a psychometric tool for measuring health literacy in the field of cancer

location_facility: Hôpital Privé des Peupliers, Ramsay Santé