title: Implementation of a Post-traumatic Stress Disorder Primary Prevention Program Within the French Army

acronym: PREPAR

summary:
Post-Traumatic Stress Disorder (PTSD) is a mental health condition that's triggered by a terrifying event perceived as a life threatening - either experiencing it or witnessing it. Lifetime prevalence of PTSD in the European population is between 0.7% and 1.9%. According to the "dose-response" model, the individuals most exposed to traumatic events (TEs) are those who are most at risk of developing this disorder. This is why it is not surprising to observe a higher prevalence of this disorder in the military population, ranging from 10% to 18% or even 45%, depending on the studies.

In the 1980s, the practice of evidence-based preventive medicine (EBM-Evidence Based Medicine) was developed. It involves the conscientious, explicit, judicious and reasonable use of modern, best evidence in making decisions about the care of individual patients. EBM integrates clinical experience and patient values with the best available research information. Health condition prevention includes several levels of action: primary, secondary or tertiary, depending on the timing of the intervention in the course of the disease.

The aim of this project is to explore the efficiency of primary prevention actions in strengthening the resilience capacities of at-risk professionals, such as the military, in order to prevent the development of PTSD and to improve it prognosis.

The objectives of this project are (i) to design a primary prevention program for PTSD specific to the military population studied and compatible with the operational constraints of field soldiers, (ii) then, to implement / validate it within the operational staff of the Mountain Infantry Brigade (MIB).

Our approach is based on an integrative reading of the processes in the risk of developing PTSD. This biopsychosocial approach targets both the factors specific to the individual (on the physiological and psychological level) and the contextual and social factors relating to his professional environment.

Three dimensions are addressed: (i) biophysiology (by integrating the study of key biomarkers of the neurobiological response to stress, and by strengthening the flexibility of the autonomic nervous system), (ii) psychology (by facilitating and measuring the development of the flexibility of coping strategies to cope with stress as well as by evaluating the moderating role of the sense mission in the development of PTSD) and (iii) the social (by facilitating community strategies aimed at reducing stigmatization and facilitating the use of care for professionals in difficulty in the institutional context).

lead_sponsor: Direction Centrale du Service de Santé des Armées


title: Randomized Controlled Study Evaluating The Contribution of a Hypnosis Intervention During a Lumbar Puncture in the Neurology Department.

acronym: HYPNOPLUS

summary: The purpose of this study is to assess the effect of hypnosis, as add on therapy, on patients requiring a lumbar puncture (LP) as part of their medical management.

study_start_date_type: Actual

status: Recruiting

study_completion_date_type: Anticipated

study_type: Interventional

design_allocation: Randomized

primary_purpose: Supportive Care

enrollment_type: Anticipated

lead_sponsor: University Hospital, Grenoble

location_facility: Neurology department of Grenoble University Hospital

intervention_type: Other

lead_sponsor_type: academique

status_simplified: Ongoing


type: Other Identifier

title: Post-surgical Patient Experience: Definition of New Indicators

acronym: CALEX

summary: The success of a surgical intervention is evaluated by different indicators: survival, functional after-effects, regression of the clinical signs that led to the intervention, rate of re-operation or re-hospitalization, etc. However, the success of an intervention and, more generally, the quality of care are complex notions that include several aspects: technical, human, narrative, relational, ethical and systemic aspects. Thus, quantitative criteria are very useful and reliable indicators, but they must be integrated into a more global vision. In particular, quality of care is not perceived in the same way by caregivers, patients and their families. The integration of the patient experience in the design and implementation of quality indicators opens new perspectives for reflection and action. For example, patient-tracer questionnaires, which make it possible to evaluate the patient's experience after the fact, have been developed by the High Authority for Health (HAS) and are now part of the quality indicators in hospitals. Some studies have adopted a qualitative approach to collect the patient's experience after surgery. However, there is currently no questionnaire based on the patient's experience evaluating the success of a surgical procedure. The objective of this work will be to report meta-narratives based on patients' experiences and in a second step to build a quality questionnaire of the surgical pathway focused on patients' needs.

study_start_date_type: Anticipated

status: Not yet recruiting

primary_purpose: Other

ipd_sharing: No

lead_sponsor: Centre Hospitalier Intercommunal Creteil

location_facility: Centre Hospitalier Intercommunal Créteil

intervention_type: Behavioral


title: Evaluation of the Detection Performance of the N Antigenemia of SARS-CoV-2 in the General Population for the Diagnosis and Screening of COVID-19

acronym: CoviBlood

summary:
SARS-CoV-2 is responsible for COVID-19. Today, RT-PCR performed on a nasopharyngeal sample remains the gold standard for diagnosing SARS-CoV-2 infection. However, several other assays have been developed to increase testing capabilities and provide rapid screening strategies such as antigenic lateral flow assays. Most recommended tests to date are based nasopharyngeal sampling that is often poorly tolerated by patients and associated with a significant risk of infection for the sampler. Saliva can be used but provide slightly lower sensitivities depending of the subsequent assay use with those samples. The detection of the N antigen of SARS-CoV-2, by ELISA or rapid immunochromatographic technique, on a serum or blood sample would make it possible to overcome these constraints and to provide a new testing alternative. ELISA tests are faster, cheaper and easier to automate than molecular biology approaches.

Blood sampling may be easier to perform in certain populations (in particular in hospitalized patients who already benefit from blood sampling, blood donors, etc.), require less equipment, and is better tolerated (immunocompromised patients subject to blood sampling repeated), and can be integrated more systematically into assessments carried out at the entrance to hospitals or in town, etc. If the N-antigen levels in blood are sufficient, rapid antigen assay on capillary blood could also provide useful testing alternatives.

In a pilot study conducted at Bichat Claude Bernard Hospital, the sensitivity of the first available commercial test was estimated at 93% (95% CI, 84.7-100), and its specificity at 98% (95% CI, 85.3-100).

The main objective of the current work is to evaluate the sensitivity of the SARS-CoV-2 N antigen detection in the serum compared to nasopharyngeal SARS-CoV-2 PCR in several populations such as symptomatic hospitalized patients, symptomatic non-hospitalized patients and asymptomatic subjects.

For each detection kit evaluated, the primary endpoint is the sensitivity (and its 95% confidence interval) of the detection of SARS-CoV-2 N antigen in serum overall and in those populations. The specificity will also be assess.

lead_sponsor: Assistance Publique - Hôpitaux de Paris

intervention_type: Diagnostic Test


title: Prevalence and Risk Factors of Dermatoporosis in Patients Over 75 Years of Age Hospitalized in Reeducation

acronym: Dermatoporose

summary:
The term dermatoporosis, by analogy to osteoporosis, was proposed by Professor Saurat to define all the manifestations linked to skin aging leading to fragility and skin failure. With age, the gradual disappearance of hyaluronic acid and its CD44 cell receptor leads to the degeneration of the extracellular matrix and then to the loss of the protective mechanical functions of the skin. It thus appears an alteration of the viscoelasticity of the skin. The most common skin manifestations of dermatoporosis are mainly located on the upper limbs. Several clinical manifestations characterize dermatoporosis: skin atrophy, senile purpura, stellate pseudo-scars, delayed healing and finally dissecting skin hematoma. There are 4 evolutionary stages of dermatoporosis described by Professor Saurat and by Doctor Kaya, in 2007: Stage 1: strong thinning of the skin with senile purpura and stellate pseudo-scars. Stage 2: manifestations of the previous stage and small, localized skin lacerations resulting from a cleavage between the dermis and the epidermis. Stage 3: more and larger skin lacerations with a noticeable delay in healing Stage 4: the progression of the lesions described above leads to the formation of dissecting skin hematomas which may progress to skin necrosis. (Saurat JH Dermatoporosis - the functional side of skin aging. Dermatology 2007 and Kaya G, dermatoporosis: A chronic cutaneous insufficiency / fragility syndrome. Clinicopathological features, mechanisms, prevention and potential treatments. Dermatology 2007).

A study by Mengeaud et al found a significant association between severe renal failure and dermatoporosis. Two studies, one in Toulouse and the other in Finland, looked at the prevalence and risk factors of dermatoporosis in patients over 60 years of age. The observational study on 202 patients over 60 years old in Toulouse shows a prevalence of 32%, with preferentially localization on the upper limbs. Stage 1 is the most common. Multivariate statistical analyzes show that dermatoporosis is significantly associated with the use of local and oral corticosteroids, anticoagulants, and chronic renal failure. On the other hand, it has not been shown to be associated with diabetes and the patient's sun exposure.Another study, dating from 2018 also found that kidney failure, taking antiaggregants and anticoagulants, corticosteroid therapy (local or systemic) are risk factors for dermatoporosis. However, no study has been carried out on a geriatric population, and the association between phototype, sun exposure and dermatoporosis has to our knowledge never been systematically investigated in the few studies conducted.

study_type: Observational

time_perspective: Prospective

ipd_sharing: Undecided


title: Restrictive Eating Disorders: From Childhood Orality Disorder to Adolescent Dysensoriality (Orality Dysensoriality and Eating Disorder)

acronym: ODYSSED

summary: This study offers to determine whether adolescent patients with a restrictive eating disorder have variations in their sensoriality compared to a control group.

ReferenceType: background

ReferenceCitation: Battle DE. Diagnostic and Statistical Manual of Mental Disorders (DSM). Codas. 2013;25(2):191-2.

ReferenceCitation: Gorwood P, Blanchet-Collet C, Chartrel N, Duclos J, Dechelotte P, Hanachi M, Fetissov S, Godart N, Melchior JC, Ramoz N, Rovere-Jovene C, Tolle V, Viltart O, Epelbaum J. New Insights in Anorexia Nervosa. Front Neurosci. 2016 Jun 29;10:256. doi: 10.3389/fnins.2016.00256. eCollection 2016. Review.

ReferenceCitation: Schoen SA, Miller LJ, Green KE. Pilot study of the Sensory Over-Responsivity Scales: assessment and inventory. Am J Occup Ther. 2008 Jul-Aug;62(4):393-406.

location_facility: Maison de Solenn Maison des Adolescents, Cochin Hospital


type: EudraCT Number

title: Administration of Fibrinogen Concentrate for Refractory Bleeding in Hematological Patients With Intensive Chemotherapy-induced Thrombocytopenia - Analysis Using Viscoelastic Haemostatic Assay (FORMAT)

acronym: FORMAT

summary: Platelet transfusions are widely employed to prevent or treat bleeding episodes in patients with thrombocytopenia. Patients with bone marrow failure secondary to haematological malignancy and chemotherapy frequently receive prophylactic platelet transfusion when platelet level reaches 10x109.L-1, to avoid spontaneous major bleeding. Due to immune or nonimmune factors, platelet refractoriness may be observed and is defined as a repeated suboptimal response to platelet transfusions with lower-than-expected post-transfusion count increments. The management of patients with alloimmunization is complex and prophylactic platelet support is no longer indicated. Therefore, platelet refractoriness remains a clinically challenging complication.

primary_purpose: Treatment

lead_sponsor: Institut de Cancérologie de la Loire

location_facility: Institut de Cancérologie Lucien Neuwirth

intervention_type: Drug

lead_sponsor_type: industriel


title: Feasibility Study of Sleep Endoscopy Under Hypnosis in a Sleep Center

acronym: DISE

summary: It is proposed to induce in a obstructive sleep apnea syndrome patient, a hypnotic trance leading to intense muscle relaxation, capable of reproducing in the upper airways (VAS) the muscle relaxation observed in sleep, at the origin of obstructive apnea and snoring. The collapsibility type obtained, classified according to Kezirian, will allow specific management by OAM in the event of predominant anteroposterior stenosis. There are no risks fort the patient. The Drug Induce Sleep endoscopy (DISE) is a fibroscopy of upper aerodigestive tract.

status: Completed

study_completion_date_type: Actual

primary_purpose: Screening

enrollment_type: Actual

lead_sponsor: Elsan

location_facility: Centre du Sommeil de la Polyclinique de Poitiers

intervention_type: Procedure

status_simplified: Completed


title: A Phase 1, Double-blind, Randomized, Placebo-controlled, First-in-human Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single and Multiple Oral Doses of ALG-055009 in Healthy Volunteers and Subjects With Hyperlipidemia, and an Open-Label Assessment of Bioavailability and Food-effect in Healthy Volunteers

summary: A Randomized Study of ALG-055009 Drug to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single and Multiple Doses in Healthy Volunteers and Subjects with Hyperlipidemia

lead_sponsor: Aligos Therapeutics


title: Ventilator-associated Pneumonia Ecology Comparison in a French ICU Center NIMES Between First and Second Wave of COVID-19 : a Retrospective Monocentric Descriptive Study

acronym: ECOLCOVID

summary: In December 2019, a new pandemic emerged, the COVID-19 disease caused by a SARS-Cov-2 virus. One of the most common symptoms of COVID-19 is mainly respiratory failure and patients requires assistance by mechanical ventilation. Ventilator-associated pneumonia (VAP) is a risk of this assistance. Since the beginning of the pandemic, Standard of care have evolved with new data. The prevalence of these VAPs seems significantly higher in the population of patients with ARDS COVID-19 (40-50%) and their ecology seems to have evolved over time, particularly in terms of bacterial resistance. Investigators want to describe and compare this evolution of bacterial and fungal ecology as well as identify potential risk factors that may be associated with these changes in ecology during different waves.

time_perspective: Retrospective

lead_sponsor: Centre Hospitalier Universitaire de Nīmes

location_facility: CHU de Nîmes - Hôpital Universitaire Carémeau


title: MAster Protocol Studying the Impact of Blood Biopsy on Screening, Diagnosis, Diagnostic and Follow-up of Solid Cancer in Adult

acronym: CIRCAN MAP

summary: This exploratory study will focus on the development of the analyses of blood biomarkers to better understand the circulating biomarkers associated with cancer diagnosis, treatment efficacy and progressive disease

lead_sponsor: Hospices Civils de Lyon

intervention_type: Biological


title: Efficacy of Prolonged Anticoagulation for Primary Prevention of Venous Thromboembolic Disease in Autoimmune Hemolytic Anemia: a Prospective, Phase II, Randomized, Multicenter Study

acronym: API-AHAI

summary:
Autoimmune hemolytic anemia (AIHA) is a rare autoimmune disease (incidence <1/100,000 population) responsible for the destruction of red blood cells by the host immune system, notably through the action of autoantibodies.

Apart from complications related to anemia, the occurrence of venous thromboembolism (VTE) in this population is frequent, estimated at 20-27%. The risk of VTE is highest during the period of hemolysis, especially during the first 3 months after the diagnosis of AIHA. This risk is 7.5 [4.7; 12.0] times greater than in the general population. No clinical predictive factor for VTE was identified and the usual factors (cancer, previous VTE, bed rest >3 days, surgery, age >70 years, heart or respiratory failure, myocardial infarction, stroke, obesity, hormone replacement therapy) were not considered. Several biological risk factors have been suggested (depth of anemia, bilirubin level, leukocyte count, antiphospholipid antibodies) but have not been confirmed in other studies.

AIHA is therefore a risk factor for VTE in its own right, and the National Diagnostic and Care Protocol (NDCP) recommends the implementation of VTE prevention during acute hemolysis (Grade C). However, the value of this prophylaxis has never been prospectively evaluated and its duration is empirical. In practice, low-molecular-weight heparin (LMWH) is generally used during "flare-ups" of AIHA (diagnosis and relapse) in hospitalized patients, but is rarely continued beyond the hospital phase when VTE also occurs in ambulatory patients.

Thus, we hypothesize that prolonged preventive anticoagulation during the 12-week risk period following diagnosis or relapse of AIHA could decrease the incidence of VTE.

In orthopedic surgery, this strategy has been proven to decrease VTE from 50% to 10-15%. In certain high-risk medical situations, prolonged prophylaxis with apixaban has been shown to decrease the occurrence of VTE from 10.2% to 4.2% in solid cancers4 and from 4-11% to 2% in myeloma.

primary_purpose: Prevention

lead_sponsor: Centre Hospitalier Universitaire Dijon


title: A Prospective, Triple Blinded, Randomized, Controlled Clinical Study of the Effectiveness and Safety of STYLAGE® M LIDOCAINE Versus STYLAGE® M in Filling Nasolabial Folds

acronym: MLIDOM

summary:
This clinical investigation is designed to compare the STYLAGE® M Lidocaïne to STYLAGE® M in terms of correction of nasolabial folds severity and pain felt by the subject, and to assess and compare the safety and effectiveness of both products.

Subjects with moderate to severe nasolabial folds will receive both treatments in a split-face design at D0, and a touch-up will be done 14 days after if necessary. The subjects will be followed-up over a 12-month period after initial injection.

lead_sponsor: Laboratoires Vivacy

intervention_type: Device


title: Outcomes of Adjuvant "Sterile Self Locking Polymer Cerclage System" to Manage Prosthetic Rehabilitation, Per Prosthetic or Primary Femoral Fractures. A Prospective, Multicentric, Simple Blind, Comparative, Non-inferiority Study, Compared to Cerclage Systems Used in Standard Care.

acronym: SERRE

summary:
The use of cerclage wiring in the management of femur fractures is common. With the increase in the placement of total hip prostheses, the occurrence of peri-prosthetic hip fractures is also increasing, notably due to an older population.

Whether it is for a fracture on a native femur or on a periprosthetic hip fracture, the use of cerclage wiring is an adjuvant additional but not the main means to ensure stable osteosynthesis, allowing re-loading and early rehabilitation of patients. This method has demonstrated its ability to improve the fixation of this fracture type, associated with osteosynthesis or hip prosthesis revision surgery. However, metal cerclage expose to a risk of metallosis which can compromise bone fusion, injury to neighboring soft parts causing pain and also injury to the surgical team when handling them. More recently, non-metallic cerclage have been developed and could overcome certain risks associated with metallic cerclage, while ensuring their bone fixing capacity and therefore bone consolidation. Indeed, non-metallic cerclage could withstand similar or even greater stresses than metallic cables, in particular concerning their resistance to rupture.

The "Sterile Self Locking Polymer Cerclage System" is a polymer cerclage which has been developed and could be used in these indications.

Thus, this study (SERRE) aims to investigate the clinical results and sequelae of adjuvant cerclage wires "Sterile Self Locking Polymer Cerclage System" in the management of prosthetic rehabilitation, per prosthetic or primary femoral fractures compared with cerclages system used in standard care.

SERRE is a 36 months follow up study in two arms :

Experimental group: "Sterile Self Locking Polymer Cerclage System"
Control group: "cerclages used in standard care" After each surgery, the patient follow-up period is 36 months. with 4 planned consultation visits after surgery at 6-8 weeks, 3, 6 and 36 months, with collection and measurement of the endpoints.

The main objective of this study is to assess the role of "Sterile Self Locking Polymer Cerclage System" of COUSIN Biotech in comparison with cerclages (metallic for the majority) used in standard care ; in the optimization of the consolidation of primary and periprosthetic femoral fractures, 6 months after surgery.

ReferenceType: result

ReferenceCitation: Lindahl H. Epidemiology of periprosthetic femur fracture around a total hip arthroplasty. Injury. 2007 Jun;38(6):651-4. Epub 2007 May 2. Review.

ReferenceCitation: Rayan F, Haddad F. Periprosthetic femoral fractures in total hip arthroplasty - a review. Hip Int. 2010 Oct-Dec;20(4):418-26. Review.

ReferenceCitation: Tsiridis E, Pavlou G, Venkatesh R, Bobak P, Gie G. Periprosthetic femoral fractures around hip arthroplasty: current concepts in their management. Hip Int. 2009 Apr-Jun;19(2):75-86. Review.

ReferenceCitation: Ferbert T, Jaber A, Gress N, Schmidmaier G, Gotterbarm T, Merle C. Impact of intraoperative femoral fractures in primary hip arthroplasty: a comparative study with a mid-term follow-up. Hip Int. 2020 Sep;30(5):544-551. doi: 10.1177/1120700019849911. Epub 2019 May 17.

name: Department of Orthopaedics, Trauma Surgery and Spinal Cord Injury, Heidelberg University Hospital, Heidelberg, Germany

family: Ferbert

full_name: Thomas Ferbert

given: Thomas

sequence: first

family: Jaber

full_name: Ayham Jaber

given: Ayham

sequence: additional

family: Gress

full_name: Nathan Gress

given: Nathan

family: Schmidmaier

full_name: Gerhard Schmidmaier

given: Gerhard

family: Gotterbarm

full_name: Tobias Gotterbarm

given: Tobias

family: Merle

full_name: Christian Merle

given: Christian

bso_classification: Medical research

datasource: user

genre: journal-article

genre_raw: journal-article

journal_name: HIP International

publisher: SAGE Publications

publisher_dissemination: SAGE Publications

publisher_group: SAGE Publications

publisher_normalized: SAGE Publications

ReferenceCitation: Ebraheim NA, Sochacki KR, Liu X, Hirschfeld AG, Liu J. Locking plate fixation of periprosthetic femur fractures with and without cerclage wires. Orthop Surg. 2013 Aug;5(3):183-7. doi: 10.1111/os.12052.

name: Department of Orthopaedic Surgery; University of Toledo Medical Center; Toledo; Ohio; USA

family: Ebraheim

full_name: Nabil A Ebraheim

given: Nabil A

family: Sochacki

full_name: Kyle R Sochacki

given: Kyle R

family: Liu

full_name: Xiaochen Liu

given: Xiaochen

family: Hirschfeld

full_name: Adam G Hirschfeld

given: Adam G

full_name: Jiayong Liu

given: Jiayong

journal_name: Orthopaedic Surgery

oa_host_type: repository

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

host_type: repository

license_normalized: no license

repository_institution: PubMed Central - Europe PMC

repository_normalized: PubMed Central

version: publishedVersion

evidence: oa repository (via pmcid lookup)

publisher: Wiley

publisher_dissemination: Wiley

publisher_group: Wiley

publisher_normalized: Wiley

title: Locking Plate Fixation of Periprosthetic Femur Fractures with and without Cerclage Wires

ReferenceCitation: Angelini A, Battiato C. Combination of low-contact cerclage wiring and osteosynthesis in the treatment of femoral fractures. Eur J Orthop Surg Traumatol. 2016 May;26(4):397-406. doi: 10.1007/s00590-016-1761-3. Epub 2016 Mar 17.

family: Angelini

full_name: Andrea Angelini

given: Andrea

family: Battiato

full_name: Concetto Battiato

given: Concetto

journal_name: European Journal of Orthopaedic Surgery & Traumatology

ReferenceCitation: Gordon K, Winkler M, Hofstädter T, Dorn U, Augat P. Managing Vancouver B1 fractures by cerclage system compared to locking plate fixation - a biomechanical study. Injury. 2016 Jun;47 Suppl 2:S51-7. doi: 10.1016/S0020-1383(16)47009-9.

title: Managing Vancouver B1 fractures by cerclage system compared to locking plate fixation – a biomechanical study

ReferenceCitation: Angelini A, Battiato C. Past and present of the use of cerclage wires in orthopedics. Eur J Orthop Surg Traumatol. 2015 May;25(4):623-35. doi: 10.1007/s00590-014-1520-2. Epub 2014 Sep 4. Review.

ReferenceCitation: Altenburg AJ, Callaghan JJ, Yehyawi TM, Pedersen DR, Liu SS, Leinen JA, Dahl KA, Goetz DD, Brown TD, Johnston RC. Cemented total hip replacement cable debris and acetabular construct durability. J Bone Joint Surg Am. 2009 Jul;91(7):1664-70. doi: 10.2106/JBJS.G.00428.

journal_name: The Journal of Bone and Joint Surgery-American Volume

publisher: Ovid Technologies (Wolters Kluwer Health)

title: Cemented Total Hip Replacement Cable Debris and Acetabular Construct Durability

ReferenceCitation: Silverton CD, Jacobs JJ, Rosenberg AG, Kull L, Conley A, Galante JO. Complications of a cable grip system. J Arthroplasty. 1996 Jun;11(4):400-4.

ReferenceCitation: Peeters I, Depover A, Van Tongel A, De Wilde L. A review of metallic and non-metallic cerclage in orthopaedic surgery: Is there still a place for metallic cerclage? Injury. 2019 Oct;50(10):1627-1633. doi: 10.1016/j.injury.2019.06.034. Epub 2019 Jul 13. Review.


title: Evaluation of the Effectiveness of the Local Application of Lemon in the Prevention of Blisters in Ultra-trail Runners

summary:
For more than a decade, worldwide participation in ultra-marathons and ultra-trails (running races longer than the 42.195 km marathon) has been increasing. Although considered benign, blisters are a common problem, with serious consequences and limiting performance.

Although blisters are a major factor limiting endurance performance, they are a reason for only 5.8% of ultra-trail runners to quit.

While equipment is improving and participants are increasing and intensifying their training, there is no consensus on the prevention of blisters in ultra-trail running, even though it is the number one factor limiting sports performance. There are few prospective interventional studies on the prevention of blisters during outdoor activities.

On many running forums, there is the hypothesis that lemon applied to the feet prevents the appearance of blisters. This hypothesis has never been scientifically studied.

The investigators hypothesize that the local application of Lemon allows a reduction in the number of blisters on ultra-trail.

The objective of this Blisters-stop 2 study is to evaluate the efficacy of local application of Lemon in preventing the appearance of blisters.

lead_sponsor: Institut de Formation et de Recherche en Médecine de Montagne


title: Prognostic Impact of Cardiac Imaging During Suspected Immune Checkpoint Inhibitor Myocarditis

acronym: IMMUNOIMAGING

summary: It consists of evaluating the advantage of routine detection of phIGFBP-1 to reduce the total duration of hospitalization for patients with a risk of preterm labor before 32 weeks of gestation without increasing the number of preterm labour.

lead_sponsor: Assistance Publique Hopitaux De Marseille

location_facility: assistance publique hôpitaux de Marseille


title: Cardio-visual Stimulation in Augmented Reality for Pain Reduction

acronym: HEART

summary: The objective of this study is to evaluate the feasibility and efficacy of an Augmented Reality (AR) biofeedback intervention to alleviate pain symptoms in individuals suffering from chronic pain of the hand and/or the forearm.

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

location_facility: Institut Régional de Médecine Physique et de Réadaptation


ReferenceCitation: Fradet M, Negretto M, Tournier E, Laurent C, Apoil PA, Evrard S, Degboe Y, Del Mas V, Lamant L, Dubreuil P, Laroche M, Mailhol C, Hermine O, Paul C, Bulai Livideanu C. Frequency of isolated cutaneous involvement in adult mastocytosis: a cohort study. J Eur Acad Dermatol Venereol. 2019 Sep;33(9):1713-1718. doi: 10.1111/jdv.15638. Epub 2019 May 17.

ReferenceCitation: Severino M, Chandesris MO, Barete S, Tournier E, Sans B, Laurent C, Apoil PA, Lamant L, Mailhol C, Laroche M, Fraitag S, Hanssens K, Dubreuil P, Hermine O, Paul C, Bulai Livideanu C. Telangiectasia macularis eruptiva perstans (TMEP): A form of cutaneous mastocytosis with potential systemic involvement. J Am Acad Dermatol. 2016 May;74(5):885-91.e1. doi: 10.1016/j.jaad.2015.10.050. Epub 2016 Feb 19.

lead_sponsor: University Hospital, Toulouse

acronym: HCQMa

location_facility: Larrey Hospital - Toulouse University Hospital

source: euctr

title: Hydroxychloroquine in Isolated Cutaneous Mastocytosis Patients or Indolent Systemic Mastocytosis With Associated Skin Involvement Patients: Proof of Concept Study

summary:
The treatment of systemic mastocytosis has two main axes:

Control of mast cell activation symptoms and
The control of proliferation (accumulation) of mast cells.

There is no standard treatment and no treatment has a marketing authorization for the treatment of monoclonal indolent mastocytosis.


title: Reproducibility of Functional Shoulder Tests for the Return to Sport of Patients Operated on Previous Shoulder Instability

summary: The aim of this study is to assess whether the indicators outcome of these tests discriminate between different populations. In particular to compare populations with shoulders without any history of injury with a population that had undergone a reduction in glenohumeral instability by the Latarjet technique.

design_allocation: Non-Randomized

primary_purpose: Diagnostic

lead_sponsor: Ramsay Générale de Santé


acronym: FAMODREP

location_facility: Necker - Enfants malades Hospital; Department of Pediatrics and Infectious Diseases

title: Interest of Famotidine in Reducing Endothelial Expression of P-selectin in Children With Sickle Cell Disease: Pilot Study, Single-center, Prospective, Non-comparative.

summary:
The purpose of this study is to determine whether oral famotidine, a histamine type 2 receptor antagonist already widely used with very few side effects in other indications in children, is effective in reducing endothelial expression of P-selectin in children with sickle cell disease (SCD).

This pilot study will constitute the essential prerequisite for a randomized clinical trial comparing the efficacy of famotidine with that of placebo in the prevention of vaso-occlusive crises in SCD patients.


title: Robot-assisted and Connected 6-minute Walk Test (TM6)

summary: Evaluation of the reliability of the PEPPER robot in assisting and recording the parameters of a TM6. Patients referred to the EFRED service for the performance of a 6MWT will be assisted during their test by the PEPPER robot. The PEPPER robot will also collect the parameters of the 6MWT and produce a report. The EFRED service technician will remain present during the 6MWT and will take note of the test parameters. An evaluation of patient satisfaction with the assistance of the Robot Pepper in the realization of the 6MWT will also be carried out.

lead_sponsor: Association Nationale pour les Traitements A Domicile, les Innovations et la Recherche


title: Real-time Monitoring of Concentration and Size Variations of Circulating Plasma Free DNA to Predict Early Response to Immunotherapies in Patients With Different Types of Cancer.

acronym: SCHISM

summary:
Immunotherapy, which can be represented by the immune checkpoint blockade, is a milestone in the progress of the ongoing struggle against cancer. However, the emergence of unexpected tumor response patterns, such as pseudo-progression or hyper-progression, might complicate the management of patients receiving these immune checkpoint inhibitors. A reliable standardized biomarker that can be used in clinical practice for predicting response to treatment, monitoring tumor evolution and evaluating treatment efficacy has not yet been established.

The general aim of this study is to assess the interest of the plasmatic free circulating DNA (cfDNA) on the clinical response for patients with different types of cancer treated with immunotherapies. The primary objective is to assess the performance of the plasmatic free circulating DNA using the estimation of the receiver operating characteristic (ROC) curve and calculation of the area under the curve (AUC) on the response rate.


title: Circulating Immunes Cells, Cytokines and Brain Radiotherapy

acronym: CYRAD

summary:
Patients with malignant tumours of the cephalic pole have a poor prognosis, despite a wide range of treatments. prognosis despite a large therapeutic arsenal. Among this arsenal, radiotherapy (RT) is one of the standard treatments for these tumours. However, this treatment can cause damage to the surrounding healthy tissue, has limited efficacy in hypoxic However, this treatment can cause damage to the surrounding healthy tissue, has limited efficacy in hypoxic tissue and can promote pro-tumour inflammation.

In these circumstances, hadrontherapy, which uses charged heavy particles, such as protons or carbon ions, is the preferred treatment. protons or carbon ions, seems more appropriate for the treatment of these tumours. However, although inflammation plays a major role in tumour development and tumour development and therapeutic response, few studies have evaluated the immune response response after proton therapy (PT) and carbon therapy (CT). The objective of this project is to study the effect of hadrontherapy on resident/circulating inflammation after brain irradiation. brain irradiation. In a first step, the impact of different PT and CT TEL on macrophages (MФ), the most abundant immune cells in malignant solid tumours, will be evaluated in vitro. malignant solid tumours, will be evaluated in vitro. In a second step, the evolution of circulating leukocytes after brain irradiation with X-rays or protons will be studied in vivo in rodents and patients. rodent and patient. In this project, we propose to study for the first time the inflammatory response after hadrontherapy in the context of a cephalic tumour. cephalic tumour. These results will allow a better understanding of the biological response response following PT and CT with the aim of optimising RT and potentially and potentially translate these data to the clinic.

lead_sponsor: Centre Francois Baclesse


title: Evaluation of Modification in VO2 Max After Performing the PAPS 53 Program

summary:
Physical inactivity is the leading cause of preventable death in developed countries, ahead of smoking. It is responsible for 5.3 million (9%) of the 57 million deaths worldwide in 2008 and 10% of deaths in Europe.

Encouraging regular physical activity in the general population is a public health priority.

Cardiorespiratory capacity, measured during an exercise test, expressed as maximal oxygen consumption (VO2 max) or Metabolic Equivalent Task (MET) = oxygen consumption at rest [3.5 ml/kg/min], is an excellent indicator of individual exercise capacity and is increased by regular physical activity (PA).

Any gain in cardiorespiratory capacity of 1 MET is accompanied by a 12% reduction in mortality whether the subjects are free of any cardiovascular pathology or have a chronic pathology, regardless of their age.

As physical activity is an integral part of the management of many diseases, it seems essential to evaluate specific protocols oriented towards the maintenance or development of strength or endurance, or even mixed protocols.

The PAPS 53 (Physical Activity and Health Pathway), set up in Mayenne, responds to the demand for prescription of adapted physical activity. It is a 3-month program with 2 one-hour sports sessions per week (30 minutes of endurance and 30 minutes of muscle strengthening).

The National Sport and Health Strategy 2019-2024 expert group recommends better defining the characteristics of physical activity (intensity, frequency, etc.) to determine the effect (dose-response) on different at-risk populations and according to the type of pathology.

Investigators proposed to study by comparison the VO2 max values obtained during the two exercise tests (at inclusion and after 3 months of physical activity program). The hypothesis is that, after completion of the PAPS program, the VO2 max value of a patient will be significantly increased.

The control group is represented by the patients who have not yet followed the adapted physical activity program. The intervention group is therefore composed of the same patients. The aim is to compare the same group of eligible patients, before and after having followed the "PAPS 53" protocol

lead_sponsor: University Hospital, Angers


title: Impact of Multi-tasking Situations on the Dismounted Soldier's Cognitive Load

acronym: SiMuCCoDé

summary:
The increased complexity of the dismounted combatant's equipment can result in a strain on the various senses (e.g., visual, auditory) that can exceed an individual's limited information processing abilities. The combatant may thus be cognitively overloaded in multi-tasking operational situations.

There has been a great deal of research conducted on cognitive load. A battery of multitasking tests has been developed in the field of aeronautics, but, to our knowledge, no measurement of cognitive load specifically dedicated to combatants has been conducted yet.

lead_sponsor: Direction Centrale du Service de Santé des Armées

location_facility: Institut de Recherche Biomédicale des Armées


title: Abnormal Thyroid Profile in Children With Attention Deficit With Hyperactivity Disorder (ADHD)

acronym: THYRADHD

summary:
Rationale: The observational data of University Children's Hospitals of Nice, suggest that about a quarter of children and adolescents with ADHD may present with an abnormal thyroid profile.

Main objective: To confirm that a subsample of children and adolescents with ADHD present with an abnormal thyroid profile using the gold standard for free fraction of hormones : chromatography with mass spectrometry.

Secondary objective: To examine to what extent this categorization holds using classic immuno-analytic assays. To characterize clinically and from a neuropsychological point of view this subsample and compare it to the other participants.

Study duration and design: 30 months (24 months for inclusion and 6 months for data analyses) open-label, (category 2 : interventional research with minimal risks or constraints), multicentre, without treatment or placebo administration.

Expected outcomes: Ancillary studies will investigate genetic physiopathological mechanisms (polymorphisms of deiodase or transmembrane carriers of thyroid hormones) and link this profile to other biological markers proposed in the literature (low ferritinemia, higher oxidative stress, atopic comorbid disease). The clinical trajectory of this subgroup and the persistence of this abnormal thyroid profile in adulthood will be a relevant issue in the future.

lead_sponsor: Fondation Lenval

location_facility: Hôpitaux Pédiatriques de Nice CHU-Lenval


title: A Pilot Study: Retrospective Evaluation of 3 Colonic Adenoma Detection Strategies During a Colonoscopy: Endoscopy Cap Associated With the Artificial Intelligence GI GENIUS ™ System, the Artificial Intelligence GI GENIUS ™ Alone and Colonoscopy Alone

acronym: COLODETECT

summary:
Retrospective study, single blind (patient), allowing a posteriori clinical data collection of 90 patients during their passage to the ambulatory endoscopy circuit, to consider 3 groups and thus to deduce a colonic adenoma detection rate for each arm :

Colonoscopy Only Group
Artificial intelligence only group (IA GI GENIUS ™ alone)
Endoscopic Cap and Artificial Intelligence Group (endoscopy cap associated with the GI GENIUS ™ IA System)


title: Effectiveness of Intraoral Scanners as a Motivation Method for Oral Hygiene Instruction

summary:
Periodontal diseases are highly prevalent inflammatory diseases. These diseases are mostly due to the development and the maturation of bacterial plaque which lead to local inflammation. Individuals can develop severe attachment loss which could lead to dental loss. To prevent them, individual plaque removal procedures self-performed by the patient by tooth brushing or interdental brushes or made by professional care (scaling), are known to improve periodontal health, and thus to prevent periodontal diseases. Moreover, oral hygiene is a major factor to increase increasing the outcomes when treatments are needed. However, patients' compliance in oral health program is one of the major limits to periodontal therapeutics.

In this study, the investigators evaluate the effectiveness of 3D intra-oral camera compared with conventional oral hygiene instructions, to improve oral health motivation.

lead_sponsor: CHU de Reims


title: Musset's Surgical Technique: Evaluation of Long-term Results (LONGOMUSSET)

acronym: LONGOMUSSET

summary:
The surgical technique of Musset has shown its effectiveness for the cure of recto-vaginal fistulas. Recto-vaginal fistulas are mostly post-obstetric (88%).

The objective of this study is to investigate the outcome of patients who underwent a Musset surgical technique, as well as their postoperative functional and anatomical results at a distance from the procedure.

lead_sponsor: Centre Hospitalier Intercommunal Creteil

location_facility: Centre Hospitalier Intercommunal de Créteil


title: Effects of Blood Pulsatility on Von Willebrand Factor During Extracorporeal CO2 Removal (ECCO2R)

summary:
The primary objective of the study is to demonstrate that the ECCO2R pulsatile configuration prevents the Willebrand factor high molecular weight multimers decrease observed under continuous blood flow configurations.

The secondary objectives are to quantify the CO2 extracorporeal removal in the pulsatile configuration, to describe complications (hemorrhagic, thrombotic and hemolytic), to describe patients' gas exchanges under ECCO2R, to describe the clinical course of the patients under ECCO2R as well as during the whole stay in the Intensive Care Unit (ICU).

ReferenceCitation: Kalbhenn J, Neuffer N, Zieger B, Schmutz A. Is Extracorporeal CO2 Removal Really "Safe" and "Less" Invasive? Observation of Blood Injury and Coagulation Impairment during ECCO2R. ASAIO J. 2017 Sep/Oct;63(5):666-671. doi: 10.1097/MAT.0000000000000544.

ipd_sharing: Yes

ipd_sharing_description: Individual participant data (IPD) that underlie results in publication could be shared. IPD detailed in the protocol of a planned metaanalysis could be shared

lead_sponsor: Assistance Publique - Hôpitaux de Paris


title: Microbiota Footprint and Frailty Phenotype in Virologically Suppressed People Living With HIV

acronym: FRAMIVIH

summary:
Analysis of gut microbiota becomes more and more accessible in recent years. Experimental data in both animal and human studies have demonstrated that imbalance of the gut microbiota which is called symbiosis may participate in an accelerated procedure of ageing as well as the expression of frailty phenotype. People living with HIV (PLHIV) present markers of phenotypic frailty on average 10 years before uninfected people.

In this population structural and functional modifications of GALT (Gut Associated Lymphoid Tissue) are observed early after HIV infection and persist despite virological suppression on ART (AntiRetroviral Treatment). These GALT modifications are associated with microbial translocation that is also correlated with immune activation and dysbiosis.

The objective of study is to explore gut microbiota of PLWH over 5 years, as well as to study associations of its longitudinal evolution with frailty markers and burden of comorbidities.

lead_sponsor: Hôpital Européen Marseille


title: Montreal Toulouse 86 Test Modified to be Used With Eye Tracking: Test Automation and Eye Course in Healthy Volunteers and Intensive Care Patients

acronym: MEXICO

summary: Assessment of the level of oral comprehension of the intensive care patient is essential to improve their care because they have often troubles like delirium.

lead_sponsor: University Hospital, Tours


acronym: APERITIF

title: Direct Oral Anticoagulants for Prevention of lEft ventRIcular Thrombus After Anterior Acute Myocardial InFarction

summary: APERITIF is a prospective randomized open-label, blinded end-point (PROBE) trial, nested in the ongoing the "FRENCHIE" registry, a French multicenter prospective observational study granted by "ANR-RHU Grand Emprunt", in which all consecutive patients admitted within 48 hours after symptom onset in a cardiac Intensive Care Unit (ICU) for an acute myocardial infarction (AMI) are included (NCT04050956). Among them, eligible Patients for "APERITIF" will be randomized into two groups: Dual Anti-Platelet Therapy (DAPT) alone or DAPT plus rivaroxaban 2.5mg twice daily for 4 weeks, prescribed as soon as possible after admission and completion of the initial percutaneous coronary intervention/angiography procedure.


type: Registry Identifier

title: Oral Bacterial and Viral Mapping by Dental Plaque in Elderly Patients With and Without Alzheimer's Disease(ORal MICrobiology in Alzheimer's Patients)

acronym: ORAMICAL

summary: The neurological disorders that accompany aging represent a major public health problem. The management of these diseases is a major medical and social priority. This project is based on the assumption that the oral cavity represents a privileged observation space to address these issues. The mouth is a site of easy access for painless sampling; there is therefore a major interest in identifying early oral infectious markers of the development or evolution of senile dementia. In addition to the interest of an early oral diagnosis, the mapping of the oral microbial flora in the demented elderly would allow a better understanding, prevention or even control of the evolution of neurodegenerative diseases. The final objective of our approach is to characterize the oral pathogens, or more probably the group of oral pathogens, which are significantly associated with Alzheimer's disease.

lead_sponsor: Centre Hospitalier Universitaire de Nice


title: Electrical Impedance Tomography: Effect of Extubation on Functional Residual Capacity

acronym: PULMOVISTA

summary:
The extubation phase is a risky period of anesthesia management. During this step, serious complications can arise: hypoxemia, laryngospasm, pharyngeal obstruction, pneumonia… In spite of these complications, extubation and its impact on respiratory function, particularly on the Functional Residual Capacity (FRC), remains poorly studied because of the difficulty to make bedside measurements.

The PulmoVista 500 is a clinical routine which provide effective non-invasive bedside measurements. It would be interesting to evaluate the impact of extubation on respiratory function, and more specifically FRC changes during and after extubation.

This study will allow a better physiopathological knowledge and a quality improvement patient extubation management.

primary_purpose: Basic Science

lead_sponsor: Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer

location_facility: Hôpital d'Instruction des Armées de Sainte Anne


title: Medical Monitoring and Somatic Diseases in Children Who Suffer From Autism Spectrum Disorder (ASD)

acronym: SDA

summary: For many reasons, medical monitoring in autistic patients is very difficult. This study is designed to determine the prevalence of comorbid diseases (neurological, cardiac, digestive, dental diseases…) in patients suffering from ASD to prevent them or diagnose them earlier.

ipd_sharing_description: NC

lead_sponsor: University Hospital, Montpellier


title: Impact of the FilmArray® Test on the Management of Ventilator Associated Pneumonia in COVID-19 ARDS

acronym: COVIDARRAY

summary:
Ventilator Associated Pneumonia (VAPs) are a very common side effect in intensive care units. They are the leading causes of nosocomial infections and excess mortality in intensive care units: associated with a controversial death rate of around 13%.

VAPs complicate about 40-50% of COVID-19 acute respiratory distress syndrome (ARDS) and the mortality would be twice higher.

Thus, in this context of the COVID-19 pandemic, this represents a considerable rate of patients.

Unfortunately, the risk factors for VAPs are poorly understood and the bacterial ecology varies around the world. Also, facing a high prevalence of multi-resistant bacteria in this population, the choice of probabilistic antibiotic therapy is complex and represents a considerable impact for care.

New microbiological rapid diagnostic techniques have appeared in recent years, among them the FilmArray® seems to present interesting diagnostic performances with the ability to detects resistance to antibiotics.

This technique has been studied in acute community pneumonia but has not been validated in VAP and even less during the COVID-19 period.

Investigators decide to conduct this study to investigate if the early identification of the pathogens and their mechanism of resistance using FilmArray® would improve the relevance of the antibiotic treatment.

The aim of this project is to evaluate the contribution of a rapid diagnostic technique to the management of Ventilator Associated Pneumonia during COVID-19 acute respiratory distress syndrome before an interventional study.

lead_sponsor: Centre Hospitalier Universitaire de Nīmes


title: PARamedical Abnormalties Detection of Traumatic Bone Lesion of the extremitIeS

summary: This study assesses the performance of radiographers in detecting radiological anomalies of the appendicular skeleton in emergency department. This is a retrospective study comparing the radiographers' diagnostic performance before and after dedicated training, assisted or not by artificial intelligence software. All performances will be evaluated and compared.

lead_sponsor: Poitiers University Hospital


title: Evaluation of the Efficacy and Safety of Tacrolimus 0.1% Ophthalmic Solution in Children With Vernal Keratoconjunctivitis Resistant to Ciclosporin 2% Ophthalmic Solution: a Single-center Retrospective Cohort Study

acronym: KERAVER

summary:
Non-interventional single-center cohort study (Rothschild Foundation Hospital) of patients aged 0 to 18 years followed up in ophthalmology for KCV, treated with tacrolimus 0.1% eye drops previously treated with ciclosporin 2% with treatment failure.

Prospective collection of quality of life from the parents and/or, if possible, the children via the QUICK questionnaire and 6 additional questions
Retrospective collection of clinical data (secondary endpoints) from the patients' medical records, aiming to compare the period before the start of treatment and the period under treatment with TALYMUS

The objective of this study is to evaluate the response to TALYMUS® treatment in patients with Vernal keratoconjunctivitis who have failed ciclosporin 2% therapy, whether due to lack of efficacy, compliance difficulties or poor tolerance.

lead_sponsor: Fondation Ophtalmologique Adolphe de Rothschild


title: A Comprehensive Retrospective Study of Cerebral MRI Anomalies in Mutated Transthyretin Amyloidosis Patients

acronym: TTR-SNC

summary:
Transthyretin amyloidosis (aTTR) initially described as a rare disease, became the most serious hereditary polyneuropathy of adult onset and family screening has made it possible to identify and follow up many asymptomatic patients and carriers of the mutation in the TTR gene.

Considered as a systemic disease with involvement of target organs (the heart, the eye, the kidney and peripheral nervous system), it seems to be more complex for neurologists according to recent publications raising the issue of central nervous system involvement.

Indeed, TTR amyloid deposits seem to be correlated with the duration of the disease. These deposits can cause cortical damage by different mechanisms: direct TTR toxicity or as a result of pathology related to cerebral amyloid angiopathy (intraparenchymal or subarachnoid hematomas, small infarcts, hemosiderin). A small number of mutations in the TTR gene cause a rare phenotype of systemic amyloidosis, the oculoleptomeningeal form, characterized by clinical neurological symptoms: progressive dementia, epilepsy, ataxia, spastic paraparesis, stroke-like episodes.

Hypothesis of the work: the central nervous system involvement is probably underestimated on the radiological description in patients with TTR mutation.

ReferenceCitation: Ikeda SI. [Cerebral amyloid angiopathy with familial transthyretin-derived oculoleptomeningeal amyloidosis]. Brain Nerve. 2013 Jul;65(7):831-42. Review. Japanese.

ReferenceCitation: Vieira M, Saraiva MJ. Transthyretin: a multifaceted protein. Biomol Concepts. 2014 Mar;5(1):45-54. doi: 10.1515/bmc-2013-0038. Review.

family: Vieira

full_name: Marta Vieira

given: Marta

family: Saraiva

full_name: Maria João Saraiva

given: Maria João

bso_classification: Biology (fond.)

journal_name: BioMolecular Concepts

publisher: Walter de Gruyter GmbH

publisher_dissemination: De Gruyter

publisher_group: De Gruyter

publisher_normalized: De Gruyter

title: Transthyretin: a multifaceted protein

ReferenceCitation: Maia LF, Magalhães R, Freitas J, Taipa R, Pires MM, Osório H, Dias D, Pessegueiro H, Correia M, Coelho T. CNS involvement in V30M transthyretin amyloidosis: clinical, neuropathological and biochemical findings. J Neurol Neurosurg Psychiatry. 2015 Feb;86(2):159-67. doi: 10.1136/jnnp-2014-308107. Epub 2014 Aug 4.

family: Maia

full_name: L. F. Maia

given: L. F.

family: Magalhaes

full_name: R. Magalhaes

given: R.

family: Freitas

full_name: J. Freitas

given: J.

family: Taipa

full_name: R. Taipa

family: Pires

full_name: M. M. Pires

given: M. M.

family: Osorio

full_name: H. Osorio

given: H.

family: Dias

full_name: D. Dias

given: D.

family: Pessegueiro

full_name: H. Pessegueiro

family: Correia

full_name: M. Correia

given: M.

family: Coelho

full_name: T. Coelho

given: T.

journal_name: Journal of Neurology, Neurosurgery & Psychiatry

publisher: BMJ

publisher_dissemination: British Medical Journal

publisher_group: British Medical Journal

publisher_normalized: British Medical Journal

ReferenceCitation: Nakagawa K, Sheikh SI, Snuderl M, Frosch MP, Greenberg SM. A new Thr49Pro transthyretin gene mutation associated with leptomeningeal amyloidosis. J Neurol Sci. 2008 Sep 15;272(1-2):186-90. doi: 10.1016/j.jns.2008.05.014. Epub 2008 Jun 24.

family: Nakagawa

full_name: Kazuma Nakagawa

given: Kazuma

family: Sheikh

full_name: Sarah I. Sheikh

given: Sarah I.

family: Snuderl

full_name: Matija Snuderl

given: Matija

family: Frosch

full_name: Matthew P. Frosch

given: Matthew P.

family: Greenberg

full_name: Steven M. Greenberg

given: Steven M.

ReferenceCitation: Charidimou A, Gang Q, Werring DJ. Sporadic cerebral amyloid angiopathy revisited: recent insights into pathophysiology and clinical spectrum. J Neurol Neurosurg Psychiatry. 2012 Feb;83(2):124-37. doi: 10.1136/jnnp-2011-301308. Epub 2011 Nov 5. Review.


title: National Epidemiological Cohort to Evaluate Covid-19 Respiratory Sequelae: a French Pneumologist Collaboration.

acronym: PNEUMOCOVID

summary: As the investigators need data on long term outcome of Covid-19, especially respiratory sequelae, a national cohort is required. To better evaluate the potential respiratory sequelae after SARS-CoV-2 infection, it is fundamental to include patients with different management at the acute phase of the Covid-19: ambulatory management, hospitalization in non ICU and in ICU units. That is why the investigators will conduct a national cohort study with all components of french pneumology which will give the investigators the opportunity to include patients in general hospital, in university hospital and in private structure. As it is a "real life" study, the investigators will include all patients who will have a consultation with a pneumologist for an evaluation 5 to 7 months after a Covid-19 infection whatever their acute disease management. The investigators will collect all available data on Covid-19 acute phase, on patients characteristics and comorbidities, on persistent symptoms after Covid-19, on exams results during the outcome evaluation (CT-scan, 6 min walk test, spirometry and DLCO, blood gas, VO2 max if realized).

lead_sponsor: Centre Hospitalier Universitaire, Amiens


title: Diagnosis of Lymphoma Using Endobronchial Ultrasound Guided Miniforceps Biopsy.

acronym: EnDol

summary: The present study aimed to assess the diagnostic performance of ultrasound-guided endobronchial intra-nodal miniforceps biopsy (EBUS-MFB) in the diagnosis of "de novo" mediastinal lymphoma.

lead_sponsor: University Hospital, Caen


title: Effect of Progesterone Levels on 15th Day After Embryo Transfer in Early Miscarriage < 7 WG or Evolving Pregancy Rates

summary: Progesterone level has been studied at days before embryo transfert. But, progesterone blood level has not been studied 15 days after embryo transfert. The aim of this study is to study progesterone level impact at 15 days after embryo transfert on evolving pregnanies or early miscarriages.


title: Aneurysmal Bone Cyst Imaging After Interventional Radiology Treatment: Clinical and Radiological Outcome

acronym: KOA-RI

summary: This study aims to describe the clinical outcomeand the radiological appearance of aneurysmal bone cyst treated by means of interventional radiology procedures (percutaneous sclerosis and endovascular embolization)

status: Enrolling by invitation

status_simplified: Unknown


title: Acceptance and Efficacy of a Smartphone-based App Using a Conversational Agent to Monitor Health Status and/or Deliver Behavioral Intervention to Reduce Psycho-social Stress

acronym: KANOPEE

summary:
KANOPEE is a free smartphone application providing screening, follow-up tools and autonomous digital interventions to lower psycho-social stress and its repercussions on sleep and behaviors in the general population.

Additionally, KANOPEE permits an adaptation of the intervention to the subject (i.e., an adapted waiting period, frequency, and content), enabling to perform innovative trial conditions.

The objective of this long-term study is to evaluate the efficacy of KANOPEE on users among the French general population exposed to psycho-social stress.

lead_sponsor: University of Bordeaux


title: Effects of Different Attentional Focus During Walking on Prefrontal Cortical Activation in Older Adults and Patients With Parkinson's Disease

acronym: AttPark

summary: Attention may influence the motor performance and frontal activity. This study will examine the effect of different attentional focus: internal, external and divided attention (dual task) on prefrontal cortical activation (fNIRS) and on gait performance. Thirty older adults and thirty PD will participate in this study.

ReferenceCitation: Baltadjieva R, Giladi N, Gruendlinger L, Peretz C, Hausdorff JM. Marked alterations in the gait timing and rhythmicity of patients with de novo Parkinson's disease. Eur J Neurosci. 2006 Sep;24(6):1815-20.

ReferenceCitation: Hausdorff JM. Gait dynamics, fractals and falls: finding meaning in the stride-to-stride fluctuations of human walking. Hum Mov Sci. 2007 Aug;26(4):555-89. Epub 2007 Jul 5. Review.

ReferenceCitation: Mahoney JR, Holtzer R, Izzetoglu M, Zemon V, Verghese J, Allali G. The role of prefrontal cortex during postural control in Parkinsonian syndromes a functional near-infrared spectroscopy study. Brain Res. 2016 Feb 15;1633:126-138. doi: 10.1016/j.brainres.2015.10.053. Epub 2015 Nov 6.

ReferenceCitation: Plotnik M, Giladi N, Dagan Y, Hausdorff JM. Postural instability and fall risk in Parkinson's disease: impaired dual tasking, pacing, and bilateral coordination of gait during the "ON" medication state. Exp Brain Res. 2011 May;210(3-4):529-38. doi: 10.1007/s00221-011-2551-0. Epub 2011 Jan 30.

ReferenceCitation: Yogev-Seligmann G, Rotem-Galili Y, Mirelman A, Dickstein R, Giladi N, Hausdorff JM. How does explicit prioritization alter walking during dual-task performance? Effects of age and sex on gait speed and variability. Phys Ther. 2010 Feb;90(2):177-86. doi: 10.2522/ptj.20090043. Epub 2009 Dec 18.

ReferenceCitation: Pelicioni PHS, Tijsma M, Lord SR, Menant J. Prefrontal cortical activation measured by fNIRS during walking: effects of age, disease and secondary task. PeerJ. 2019 May 3;7:e6833. doi: 10.7717/peerj.6833. eCollection 2019.

ReferenceCitation: Wulf G, Höß M, Prinz W. Instructions for motor learning: differential effects of internal versus external focus of attention. J Mot Behav. 1998 Jun;30(2):169-79. doi: 10.1080/00222899809601334.

ReferenceCitation: Holtzer R, Verghese J, Allali G, Izzetoglu M, Wang C, Mahoney JR. Neurological Gait Abnormalities Moderate the Functional Brain Signature of the Posture First Hypothesis. Brain Topogr. 2016 Mar;29(2):334-43. doi: 10.1007/s10548-015-0465-z. Epub 2015 Nov 27.

ReferenceCitation: Maidan I, Bernad-Elazari H, Giladi N, Hausdorff JM, Mirelman A. When is Higher Level Cognitive Control Needed for Locomotor Tasks Among Patients with Parkinson's Disease? Brain Topogr. 2017 Jul;30(4):531-538. doi: 10.1007/s10548-017-0564-0. Epub 2017 Apr 24.

ReferenceCitation: Yogev-Seligmann G, Hausdorff JM, Giladi N. The role of executive function and attention in gait. Mov Disord. 2008 Feb 15;23(3):329-42; quiz 472. Review.

ReferenceCitation: Lu CF, Liu YC, Yang YR, Wu YT, Wang RY. Maintaining Gait Performance by Cortical Activation during Dual-Task Interference: A Functional Near-Infrared Spectroscopy Study. PLoS One. 2015 Jun 16;10(6):e0129390. doi: 10.1371/journal.pone.0129390. eCollection 2015.

ReferenceCitation: Udina C, Avtzi S, Durduran T, Holtzer R, Rosso AL, Castellano-Tejedor C, Perez LM, Soto-Bagaria L, Inzitari M. Functional Near-Infrared Spectroscopy to Study Cerebral Hemodynamics in Older Adults During Cognitive and Motor Tasks: A Review. Front Aging Neurosci. 2020 Jan 21;11:367. doi: 10.3389/fnagi.2019.00367. eCollection 2019. Review.

ReferenceCitation: Kal EC, van der Kamp J, Houdijk H. External attentional focus enhances movement automatization: a comprehensive test of the constrained action hypothesis. Hum Mov Sci. 2013 Aug;32(4):527-39. doi: 10.1016/j.humov.2013.04.001. Epub 2013 Jun 30.

ReferenceCitation: Nieuwhof F, Reelick MF, Maidan I, Mirelman A, Hausdorff JM, Olde Rikkert MG, Bloem BR, Muthalib M, Claassen JA. Measuring prefrontal cortical activity during dual task walking in patients with Parkinson's disease: feasibility of using a new portable fNIRS device. Pilot Feasibility Stud. 2016 Sep 23;2:59. eCollection 2016.

ReferenceCitation: Yogev-Seligmann G, Sprecher E, Kodesh E. The Effect of External and Internal Focus of Attention on Gait Variability in Older Adults. J Mot Behav. 2017 Mar-Apr;49(2):179-184. doi: 10.1080/00222895.2016.1169983. Epub 2016 Aug 11.

ReferenceCitation: Holtzer R, Mahoney JR, Izzetoglu M, Izzetoglu K, Onaral B, Verghese J. fNIRS study of walking and walking while talking in young and old individuals. J Gerontol A Biol Sci Med Sci. 2011 Aug;66(8):879-87. doi: 10.1093/gerona/glr068. Epub 2011 May 17.

ReferenceCitation: Farid L, Jacobs D, Do Santos J, Simon O, Gracies JM, Hutin E. FeetMe® Monitor-connected insoles are a valid and reliable alternative for the evaluation of gait speed after stroke. Top Stroke Rehabil. 2021 Mar;28(2):127-134. doi: 10.1080/10749357.2020.1792717. Epub 2020 Jul 13.

lead_sponsor: Centre Hospitalier Régional d'Orléans


title: Prevalence and Risk Factors of Chronic Thrombo-embolic Disease After a Pulmonary Embolism Event The PACTE Registry

acronym: PACTE

summary:
Venous thromboembolic disease (VTE) is a common clinical entity whose two manifestations are deep vein thrombosis (DVT) and pulmonary embolism (PE). After an acute PE, almost half of the patients complain residual dyspnea, despite well-conducted curative anticoagulation. Some will present persistent defects on lung scan-scintigraphy, without pulmonary hypertension. This condition defines Chronic-Thrombo-Embolic Disease(CTED). The prevalence of CTED after PE is poorly known as are its risk factors.

The primary objective is to determine the prevalence of CTED at 3 or 6 months, depending on the provoked or unprovoked character, after a PE.

The secondary objectives are:

To determine the potential risk factors for the occurrence of CTED.
To look for an association between the persistence of DVT and the occurrence of CTED.
To look for an association between the diagnosis of CTED and PE recurrence during the 12-month follow-up.
To determine the diagnostic performance of the clinician alone compared to the lung scintigraphy (gold standard) for the diagnosis of CTED.
To compare the impact on the quality of life (QoL) with or without CTED.
To determine the correlation between impaired QoL and the degree of residual obstruction on lung scintigraphy.


title: Stress and Resilience in Anesthesia Professionals

acronym: ResiStress

summary: The purpose of this study was to analyze the correlation between the resilience of anesthesia professionals and the stress measured during a simulation session.

lead_sponsor: University Hospital, Grenoble


title: Prospective Randomised Controlled Study in 2 Parallel Arms Comparing Corneal Haze, Visual and Refractive Outcomes and Postoperative Pain According to the Mode of De-epithelialisation (Laser Versus Manual Alcohol) During Photorefractive Keratectomy

acronym: H-TransPKR

summary:
surgical correction of ametropia. A number of improvements have been introduced to overcome the side effects and complications such as corneal haze, epithelial irregularities induced by wound healing, pain and delayed visual acuity recovery associated with PRK surgery. During traditional PRK, the corneal epithelium is mechanically debrided before stromal ablation is performed. Alcohol PRK is frequently used as an alternative to mechanical epithelial debridement and is considered simpler and faster. Transepithelial PRK (TransPRK) is a new method in which the corneal epithelium is photoablated by the laser in one step using a specific ablation profile.

This study attempts to establish a means of quantitatively and objectively measuring corneal haze, using patented software based on optical coherence tomography (OCT) of the cornea. This will confirm or refute the hypothesis of a lower occurrence of corneal haze after TransPRK (experimental group) versus PRK with alcohol (control group). Each patient will have one eye randomised to one of the two groups being compared.


title: Opioid Free Anesthesia in Total Hip Arthroplasty. A Randomized, Controlled and Triple-blind Clinical Trial

acronym: OFATHA

summary:
Total hip arthroplasty (THA) is one of the most common orthopedic surgical procedure and is associated with severe pain in the immediate postoperative period, thus limiting early recovery.

Postoperative pain management in THA requires multimodal analgesia, combining drugs and injection of a local anesthetic (LA). But, the best anesthesia strategy to provide optimal postoperative analgesia in THA remains controversial. Opioid free anesthesia could limit the episodes of hyperalgesia as well as tolerance and addiction to opioids.

The hypothesis of this study is that an opioid free anesthesia using dexmedetomidine could improve analgesia after THA.

The main objective of this monocenter, prospective, randomized, triple-blind, controlled trial is to assess the interest of opioid free anesthesia using dexmedetomidine on morphine consumption after THA.

lead_sponsor: CMC Ambroise Paré


title: Clinical and Radiological Evaluation of Two Mastoid Filling Products in Patients With Cholesteratoma.

acronym: MASTOS

summary: to compare, the osseous density in the mastoid of two products used to obliterate the mastoid during surgery for cholesteatoma

lead_sponsor: University Hospital, Brest


title: EFFECT OF FOOD ALLERGENS ON DUODENAL MUCOSAUS BY CONFOCAL ENDOSCOPIC IMAGING Cellvizio

acronym: FAST

summary: Irritable Bowel Syndrome (IBS), or functional colopathy, is a chronic disease that affects 10% to 20% of the world's population.This syndrome is characterized by chronic abdominal pain or discomfort as well as a change in bowel habits (constipation or diarrhea) in the absence of structural or metabolic abnormalities (e.g. celiac disease, Crohn's disease). These symptoms have an impact on the quality of life of these patients who must therefore integrate the management of their disease into their daily life.IBS is subdivided into 3 subtypes according to the predominant symptom: the IBS-D subtype which groups together patients who have a predominance of diarrheal episodes, the IBS-C subtype which groups together patients who have a predominance of '' episodes of constipation and finally the IBS-M subtype which includes patients whose two symptoms mentioned above are observed without predominance

lead_sponsor: Clinique du Trocadéro


title: Endoprothesis Long-term Behavior After Subrenal Abdominal Aortic Aneurysm

acronym: COLONEA

summary: The strength of movement which are applied on the EVAR are not only cranio-caudal but also lateral. The movement of the EVAR's body within the aneurysm could be an instability's criteria of the EVAR. The investigators would like to show that this lateral movement is a risk factor of reintervention they should follow and suggest a reinforced medical follow-up to avoid complications.

lead_sponsor: Centre Hospitalier Universitaire de Besancon


title: Caractéristiques épidémiologiques et méthodes de prévention Des Ampoules Chez Les Coureurs d'Ultra-trail

summary:
PRIMARY OBJECTIVE : To evaluate the methods of prevention of the appearance of blisters set up by the runners before and during an ultra-trail

SECONDARY OBJECTIVES :

To evaluate :

The main locations of blisters.
The severity of blisters
The effectiveness of prevention methods To evaluate the incidence of blisters in an ultra-trail context.

lead_sponsor: Institut de Formation et de Recherche en Médecine de Montagne


title: A Retrospectice Evaluation of the Feasibility and Usefulness of a Percutaneous Vertebroplasty Performed on Patients Treated With Posterior Fixation Suffering Non-union After a Traumatic Non-neurologic Vertebral Fracture

summary:
Traumatic thoracolumbar vertebral fractures are frequently treated with posterior fixation (PF) and vertebral augmentation, but sometimes vertebral augmentation is not performed, being judged too risky under fluoroscopic guidance alone. An adjuvant CT/fluoroscopy guided percutaneous vertebroplasty (PVP) could be an option.

The aim was to evaluate feasibility, safety and effectiveness of PVP in patients with vertebral non-union (VNU) following PF performed without concomitant vertebral augmentation.

All patients treated in our institution with PVP between July 2015-July 2020 were retrospectively reviewed. Patients treated with CT/fluoroscopy guided PVP under local anesthesia for symptomatic VNU following PF were selected. Three criteria were established to assess cement distribution, considering vertebral filling of: 1)fracture cleft, 2)anterior two-thirds of the vertebral body, 3)from superior to inferior endplates. Numeric pain rating scale (NPRS) assessing grade of discomfort (0=no pain; 10=worst pain) and complications were evaluated before and one month after PVP.

ipd_sharing_description: no data sharing plan has been established


title: Pilot Study Assessing the Feasibility and Reliability of Measurements of Skin's Parameters Hydration by Electrochemistry

acronym: SKINBIOSENSE

summary:
To date measuring the effect of dermocosmetic products on the main identified factors of aging and alteration of the skin barrier is based on invasive and expensive experiments. Electrochemistry enables to measure a specific signal for a substance of interest e.g. Vitamin C using an surface contact with an electrode.

Therefore, this study will evaluate the reliability and feasibility of measurements of skin's hydration parameters such as NMF and squalene using electrochemistry. These study will be made on three groups of individuals with different skin types: dry skin i.e. atopic dermatitis patients, oily skin i.e. acne skin and a control group of individual without facial dermatosis. Collects of parameters of interest will be made by using patch using electrochemistry (contact with an electrode and potentiostat to detect an electric signal) . It is a simple method that relies on a sensor / electrode pair that allows a study of the surface molecules of the skin. Application in the measurement of vitamin C in food products has already been validated.

On a second hand, a collect by chromatography of the parameters of interest will be carried out in order to compare the new method with the reference method.

This procedure has been developed via a procedure including collecting surface parameters using a patch an developping special electrodes and miniaturized detecting signal tool (potentiostat)

lead_sponsor: Assistance Publique - Hôpitaux de Paris

location_facility: Assistance Publique Hôpitaux de Paris - CHU Henri Mondor


title: VACuum-Assisted Closure for Necrotizing Soft Tissue infecTIONs

acronym: VACATION

summary: Intro: Necrotizing and soft tissue infections (NSTI) are life-threatening bacterial infections characterized by subcutaneous tissue, fascia or muscle necrosis. The hospital mortality of NSTI is high, comprised between 20 and 30%. NSTIs represent the 4th cause of septic shock. Early management of NSTIs requires a coordinated and multidisciplinary approach, including broad-spectrum antibiotic administration, management of organ failures and aggressive surgical debridement with excision of all necrotic and infected tissues. NSTIs involve the lower limbs in about 70% of cases and lead in 15% of cases to limb amputation. During the early post-operative phase, daily wound care is required using conventional dressings. As soon as the infectious process is controlled, typically within 7 to 10 days of the initial debridement, the main goal of wound dressing is to allow for a granulation tissue to develop so that to perform a skin grafting. Negative pressure wound therapy (NPWT), which consists in applying a negative pressure on the wound surface, may be used to this effect. A dedicated dressing is connected to a device that generates a negative pressure and collects exudates. NPWT may have a positive effect on wound healing by removing exudate, increasing regional perfusion and patient comfort and reducing infections. Beneficial effects of NPWT have been suggested by case series. However, no randomized controlled trial are currently available to adequately assess its efficiency and the 2014 guidelines of the Infectious Diseases Society of America (IDSA) on NSTI did not provide recommendations regarding NPWT use for managing NSTI wounds. The study's hypothesis is that in patients managed for NSTIs, NPWT: 1) may accelerate skin grafting and complete wound healing; and 2) improve functional outcomes.


title: A Phase 1/2 Open Label Non Randomized Study, Multicentric, Single Arm Evaluating the Safety and Efficacy of Gene Therapy of the Severe Combined Immunodeficiency (SCID) Caused by Mutations in the Human DCLRE1C Gene (Artemis) by Transplantation of a Single Dose of Autologous CD34+ Cells Transduced ex Vivo With the G2ARTE Lentiviral Vector Expressing the DCLRE1C cDNA

acronym: ARTEGENE

summary: The purpose of this study is to evaluate the Safety and Efficacy of Gene Therapy of the severe combined immunodeficiency (SCID) caused by mutations in the human DCLRE1C gene (Artemis) by transplantation of a single dose of autologous CD34+ cells transduced ex vivo with the G2ARTE lentiviral vector expressing the DCLRE1C cDNA.

location_facility: Department of Pediatric Immunology, Hematology and Rheumatology UIHR, Necker-Enfants Malades Hospital

intervention_type: Genetic


title: Study of the Effects of Adolescent Weight Disorders (Obesity, Anorexia Nervosa) on Heart Function

summary:
The study aims to better understand the functioning of the heart of children and adolescents with anorexia nervosa or obesity, compared to the heart function of control subject. This project seeks to find out if a weight disorder affects the heart and whether a systematic cardiac assessment with appropriate management is then to be considered.

To meet this objective, several analyzes are planned including a speckle tracking echocardiography, allowing a non-invasive study of myocardial deformations.

The hypothesis is that two opposite weight disorders (anorexia nervosa and obesity) lead to similar complications: inflammation, fibrosis altering the myocardial structure and therefore its contractility. Both systolic and diastolic dysfunction appear. Investigator hypothesize that the determinants of this dysfunction involve part of the alteration of body mass, and partly qualitative alterations specific to each pathology.

lead_sponsor: University Hospital, Clermont-Ferrand


title: Long Term Brain Toxicity of Chemotherapy in Patients Treated for a Bone TumorDuring Childhood or Adolescence

acronym: OSE

summary: To assess the neurocognitive outcomes in patients treated with chemotherapy for a malignant bone tumor during childhood and adolescence and the factors associated with neurocognitive impairment and/or complaints

lead_sponsor: Gustave Roussy, Cancer Campus, Grand Paris


title: Oral Health Related Quality of Life of Patients With Rare Diseases Followed at Necker Hospital: a Qualitative Approach

summary: The main objective of the study is to assess the oral health-related quality of life of patients with rare diseases and followed in the rare disease centers of expertise at Necker Hospital in Paris by semi-structured interviews.


title: Phenotype Severity of RSV-infections in Twins During the First Year of Life

acronym: TwinSeVeRS

summary: Respiratory syncytial virus (RSV) infection is the most common cause of severe lower respiratory tract infection (LRTI) in the pediatric population worldwide. Age at the time of infection, prematurity, multiparity, exposure to smoke and the level of passive immunity transmitted at birth are the main risk factors for lower respiratory infection associated with RSV. Other factors, including the innate immune response, respiratory microbiota, and intra-host viral heterogeneity, may also affect outcomes but are not fully considered in RSV infection. Exploring the impact of these factors is difficult due to the heterogeneity of the population which makes statistical adjustment difficult. Thus, twin models are useful in understanding the impact of the host on the environment, as twins often share similar exposure to infection and many risk factors, but not all are ie different prenatal and postnatal conditions, differential transfer of maternal antibodies and the genetic makeup of heterozygotes.

lead_sponsor: Hospices Civils de Lyon

location_facility: Hôpital Femme-Mère-Enfant des Hospices Civils de Lyon


title: Complex Post-traumatic Stress Disorder: What Symptomatological Specificities

acronym: StuCoTra

summary: A better understanding of the Complex Post-Traumatic Stress Disorder would allow a management as close as possible to the specificities of this one, but also a better training of professionals and adapted therapeutic indications.

lead_sponsor: Raincy Montfermeil Hospital Group

location_facility: USAP CHI Robert Ballanger Boulevard Robert Ballanger


title: A Randomized, Double Blind, Multicenter, Multinational, Placebo Controlled, Parallel Group, Single Dose, Adaptive Efficacy and Safety Study of Glenzocimab Used as an add-on Therapy on Top of Standard of Care un the 4.5 Hours Following an Acute Ischemic Stroke

acronym: ACTISAVE

summary:
A randomized, double blind, multicenter, multinational, placebo controlled, parallel group, single dose, adaptive phase II/III study (respectively Part 1 and 2).

The study evaluates the efficacy and safety of a fixed dose of glenzocimab (1000 mg IV over 6 hrs including initial bolus of 15 minutes) on top of the best standard of care.

ReferenceCitation: Voors-Pette C, Lebozec K, Dogterom P, Jullien L, Billiald P, Ferlan P, Renaud L, Favre-Bulle O, Avenard G, Machacek M, Plétan Y, Jandrot-Perrus M. Safety and Tolerability, Pharmacokinetics, and Pharmacodynamics of ACT017, an Antiplatelet GPVI (Glycoprotein VI) Fab. Arterioscler Thromb Vasc Biol. 2019 May;39(5):956-964. doi: 10.1161/ATVBAHA.118.312314.

ReferenceCitation: Renaud L, Lebozec K, Voors-Pette C, Dogterom P, Billiald P, Jandrot Perrus M, Pletan Y, Machacek M. Population Pharmacokinetic/Pharmacodynamic Modeling of Glenzocimab (ACT017) a Glycoprotein VI Inhibitor of Collagen-Induced Platelet Aggregation. J Clin Pharmacol. 2020 Sep;60(9):1198-1208. doi: 10.1002/jcph.1616. Epub 2020 Jun 4.

lead_sponsor: Acticor Biotech

location_facility: Centre Hospitalier Universitaire de Bordeaux,


title: Assessment of the Impact of the COVID-19 Pandemic on Drug Use and on the Perception of Remote Monitoring by Cancer Patients Followed in the ONCORAL Program

acronym: ONCORAL-Covid

summary:
The COVID-19 pandemic has profoundly changed the organisation of care. Teleconsultation has replaced hospital medical consultations in order to reduce the risk of patient exposure to the virus.

Within the framework of the Oncoral multidisciplinary outpatient / hospital program of follow-up, carried out by the Hospices Civils de Lyon for ambulatory patients treated with oral anticancer drugs, interviews with the pharmacist and/or nurse, which were previously organised face-to-face, have been replaced by telephone interviews, ensuring continuity of follow-up for patients without having to come to the hospital.

This study focuses on a telephone survey to describe the impact of the COVID-19 pandemic health crisis on the drug exposure of cancer patients followed in the Oncoral program, their treatment management, their perception of teleconsultation and their IT resources for remote monitoring.

location_facility: Service Pharmaceutique, Hospices Civils de Lyon


title: Registry of Management Strategies for Patients With COVID-19 in Healthcare Establishments

acronym: HOPICOV

summary: The purpose of the study is to describe medical care strategies implemented by healthcare establishments for patients affected by COVID-19

lead_sponsor: Centre Hospitalier Emile Roux


title: Role of the Gastric Tube in the Preoperative Management of Hypertrophic Pyloric Stenosis

acronym: SONPYL

summary: Pyloric stenosis is a current condition in pediatric surgery. The medical management prior to surgery consists of ionic correction. The nasogastric tube is commonly used to prevent gastric fluid inhalation before surgery, but there is no study on it benefits in this specific use. Other studies suggest that utilization of a gastric tube in pyloric stenosis may increase the duration of the medical treatment. The aim of the study is to evaluate the benefit of the nasogastric tube to prevent respiratory complications. This retrospective, monocentric and descriptive study include all patients hospitalized for pyloric stenosis in the university hospital in Amiens between 2014 and 2021. Patients with and without nasogastric tube prior to surgery are compared, regarding respiratory complications define as use of antibiotic, or oxygen therapy or infection in the lungs X-ray before surgery. The investigators analyze pre-operative data: vomiting, dehydration, time to ionic disorders correction and pain, and also notice the length of hospital stay. Data during hospitalization are analyzed and will be noticed the last medical contact represent by the post-operative consultation.

lead_sponsor: Centre Hospitalier Universitaire, Amiens


title: Evaluation de l'Incidence Des évènements hémorragiques et ischémiques en Post-angioplastie Chez Des Patients Coronariens anticoagulés Dans le Cadre d'Une Fibrillation Auriculaire

acronym: FACOREV

summary:
Atrial fibrillation (AF) is a supraventricular arrhythmia characterized by uncoordinated and fast atrial activity, and coronary artery disease (chronic and acute coronary syndrome) is characterized by a generally atheromatous narrowing of the coronary arteries. Angioplasty is necessary to restore arterial circulation in coronary artery disease. A dual anti-aggregating therapy is then initiated in these patients in parallel with treatment of AF with anticoagulation. This triple therapy exposes the patient to an increased risk of hemorrhage. The combination of oral anticoagulation with antiplatelet inhibitor in long-term anticoagulated patients requiring stent placement has been studied in several recent trials (e.g. WOEST, PIONEER AF PCI, REDUAL PCI and AUGUSTUS). The results of these studies have formed the basis of the European recommendations of 2017 and 2020, whereby the therapeutic strategy depends on the risk of hemorrhage or ischemia. However, the hemorrhagic risk assessment factors included in the scores overlap with those for ischemic risk. It is therefore difficult to determine the predominant risk for each patient. Thus, uncertainties persist as to the optimal duration of a triple therapy and the optimal recommended dose.

In this study, the investigators aim to establish an inventory of the current practices by evaluating the incidence of hemorrhagic and ischemic events in post-angioplasty in anticoagulated coronary patients in the context of atrial fibrillation.

lead_sponsor: Centre Hospitalier Universitaire de Nīmes


title: Combined Flow-pressure Study of Cerebrospinal Circulation Using CSF Perfusion Tests and Phase-contrast MRI - Reversible Dementia Substudy

acronym: REVERT

summary:
Normal pressure hydrocephalus (NPH) can cause a type of dementia. However, this type of dementia is the only one that is reversible. To treat this dementia it is necessary to evacuate the accumulation of CSF from the brain to another body cavity using a device called a shunt. But the implantation of this shunt is only effective when the cause of the pathology is an alteration of the normal circulation of the CSF. To diagnose these patients, morphological MRI and lumbar puncture are standard approaches used but remain perfectible in diagnostic terms.

The main objective is to build a new model of the interaction of intracranial pressures and fluids in order to obtain a new parameter allowing to obtain information on the cerebral biomechanics.


title: Evaluation of the Impact of a Connected Application on the Follow-up of Patients Treated for Glial Lesions Operated: a Prospective, Randomized Study

acronym: TELEGLIO

summary: This study is to evaluate the efficacy of a mobile app for monitoring the quality of life of patients but also on detection delay of side effects and/or complications linked to the therapeutic management. This allow to adapt their care more quickly, through a prospective randomized study. The impact of this connected monitoring of patients' anxiety will also be evaluated in this study as well as the time taken by the medical team to manage alerts generated by this application.

lead_sponsor: Ramsay Générale de Santé


title: Fluid Resuscitation for Suspected Sepsis in Paediatric Emergency Departments (FRESSPED): a French Multicenter Prospective Observational Study

acronym: FRESSPED

summary: With 25.2 million children affected and 3.4 million deaths in 2017, paediatric sepsis is the leading cause of under-five mortality worldwide and has recently been described as "significant global health threat" by the World Health Organization. In addition to early antibiotics, fluid bolus therapy (FBT) is one of the cornerstones of management, due to the theoretical improvement of cardiac output, oxygen delivery and organ perfusion. In the absence of a consensual and operational definition to date, the latest international guidelines of the Surviving Sepsis Campaign 2020 (SSC-2020), refers to children (≥ 37 weeks gestation at birth to 18 years old) with severe infection leading to cardiovascular (i.e., "septic shock") or non-cardiovascular organ dysfunction (i.e., "other sepsis-associated organ dysfunction" or former "severe sepsis"). The SSC-2020 specifies the modalities for paediatric sepsis management, particularly concerning FBT, with, for example, the preferential use of balanced crystalloids, and a target volume of 40-60ml/kg at one hour of recognition using boluses of 10-20ml/kg in children who have access to a paediatric intensive care unit (PICU) in their health system. Further, it is now well established that compliance with international guidelines is associated with improved outcomes in paediatric sepsis. Despite the importance of awareness and implementation of the SSC-2020, there are, to our knowledge, no studies evaluating its application in children. We prospectively conducted the Fluid Resuscitation for Suspected Sepsis in Paediatric Emergency Departments (FRESSPED) study in 25 hospitals over five weeks between November 2021 and March 2022, whose principal objective was to assess doctors adherence to the SSC-2020 guidelines when performing FBT in infants and children with suspected sepsis in French paediatric emergency departments.


title: Monocentric Randomized Study Evaluating the Impact of an Early Multidisciplinary Program in Elderly Subjects Starting a Chemotherapy for Digestive Cancer: Multidisciplinary Evaluation of Elderly Patients With Digestive Cancer (EPODIG-G)

acronym: EPODIG-G

summary: This is a monocentric, comparative, open-label, randomized parallel group study enrolling elderly subjects hospitalized in Strasbourg Europe Cancerology Institute (ICANS), starting chemotherapy or targeted therapy for the treatment of digestive cancer.

lead_sponsor: Institut de cancérologie Strasbourg Europe


title: Study of the Contribution of Virtual Reality Distraction in Peripheral Intravenous Catheter Insertion to Children From 6 to 11 Years in a Pediatric Day Hospital

summary:
Main objective :

Evaluate the effect of using a virtual reality mask during the peripheral intravenous catheter insertion in a pediatric day hospital on the pain and anxiety in children from 6 to 11 years old.

Hypothesis :

Using virtual reality mask during the peripheral intravenous catheter insertion would reduce the 6 to 11 child's pain, the children and parents' anxiety, would improve satisfaction of children, parents and nurse about the care and would reduce time and cost of the procedure.


title: Imaging for the Evaluation of Transthyretin Cardiac Amyloidosis Prevalence of Patients Over 65 Hospitalized in Cardiology Wards (the IMPACT Study)

acronym: IMPACT

summary: Heart failure with preserved ejection and hypertrophic cardiomyopathy are common diseases and often associated with transthyretin cardiac amyloidosis (TTR-CM), especially in elderly people. Nevertheless, research of TTR-CM is recommended in patients with ventricular hypertrophy without other cause such as valvular disease or hypertension. Therefore, the exact prevalence of TTR-CM remains unknown. We aim to determine the prevalence of TTR-CM in patients with ventricular hypertrophy and aged ≥ 60 years old, hospitalized in our cardiology department (CHU de Poitiers) by performing bone scintigraphy and research of AL amyloidosis.

lead_sponsor: Poitiers University Hospital


title: A Randomised Controlled Trial Comparing Pre-oxygenation Strategies With High-flow Humidified Nasal Oxygenation Versus Apnoeic Facemask Oxygenation During Rapid Sequence Induction in Children Aged Less Then 11 Years

acronym: OPTINECK

summary:
This randomised study aims to compare the utilization of high-flow humidified nasal oxygenation (HFNO) with standard care, using apnoeic facemask oxygenation, during rapid sequence induction (RSI) of anesthesia in young children.

170 children aged less then 11 years, admitted to the operating room for surgery and with a medical indication of a RSI of anesthesia will be recruited in one university hospital (Necker-Enfants-Malades in Paris).

Children will be randomly assigned into two groups: the control group will benefit of standard care and the HFNO group will receive heated and humidified oxygen through a nasal cannula device during pre-oxygenation and apnoea time prior to tracheal intubation.

HFNO has been evaluated and showed benefits in rapid sequence induction of anesthesia in adults and prolonged apnea time before desaturation in children. To the investigators' knowledge the potential benefit of HFNO during RSI in young children remain to be evaluated.


title: Nterest of Drug Reconciliation to Ensure the Continuity of the Treatment at Discharge

acronym: ICOCON

summary:
From a regulatory point of view, medication reconciliation is a necessary process to ensure safe medication management for patients. According to national studies and the international scientific literature, the information received by patients and health professionals at discharge from hospital is insufficient.

Medication reconciliation at discharge reduces medication errors and rehospitalisation, but few studies have been conducted on the impact of a coordinated and reliable care pathway on medication continuity.

The iCoCon study will enable a new healthcare organisation to be set up in order to improve the quality of the patient pathway and the patient's medication management.

This new organisation is part of the policy of continuous improvement of the quality and safety of care

lead_sponsor: Centre Hospitalier le Mans


title: Validation of a Predictive Rule for the Diagnosis of Viral Meningitis in Adult Emergency Departments

acronym: Adult-BMS

summary:
Meningitis is the development of an inflammatory reaction in the meningeal space, most often of infectious origin. Many pathogens can cause meningitis, the severity of which varies greatly. Patients presenting with a febrile meningeal syndrome are most often managed in the emergency room, where the challenge for physicians is to quickly differentiate bacterial and viral meningitis.

Viral meningitis is the most common, with enterovirus meningitis having a classically excellent prognosis. Bacterial meningitis is less frequent but more serious.The current public health objective is to save antibiotics.

We hypothesize that the BMS score can be used to exclude bacterial meningitis in the emergency department in an adult European population of patients with suspected bacterial meningitis.


title: Comparison of Defocus Incorporated Multiple Segments® (DIMS®) Lenses Alone Versus Monofocal Lenses + Atropine 0.05% Eyedrops on the Evolution of Ocular Axial Length at 2 Years in Myopia Control in Children: Single-centre Prospective Randomised Controlled 1:1 Open-label Non-inferiority Study

acronym: ATROSMART

summary:
Myopia is the most common refractive disorder in the world. Many strategies have been developed to control myopia in children. Among them, the instillation of low-concentration atropine eyedrops has been proven to be effective in numerous publications. Nevertheless, the spreading of atropine use is limited by: (1) its uneven availability, (2) a proportion of children with no or poor response, (3) some issues of long-term compliance (4) the possibility of a rebound effect after treatment cessation.

Among the non-drug myopia control strategies, corrective lenses including the Defocus Incorporated Multiple Segments® (DIMS®) technology have demonstrated their effectiveness in a previous study (Hong Kong) when compared to monofocal lenses.

The aim of this study is to compare the efficacy of DIMS lenses alone versus atropine 0.05% eyedrops + monofocal lenses, on the evolution of ocular axial length at 2 years in myopic children.

lead_sponsor: Fondation Ophtalmologique Adolphe de Rothschild


title: Characterization of the Viral Genome and Humoral Immune Response in COVID-19 Vaccinated Patients With SARS-CoV-2 Infection

acronym: COVID-IVAC

summary: Vaccination of the population is crucial in the fight against the COVID-19 pandemic. Although most available vaccines have an estimated efficacy against symptomatic infection of 65-95%, this can be significantly reduced if the patient has co-morbidities such as immunosuppression or if the full vaccination schedule is not followed. Infection with SARS-CoV-2 variants, carrying mutations, notably on the spike protein, may also be associated with escape from immunity acquired by vaccination. Indeed, in vitro studies have shown a decrease in sensitivity to neutralizing antibodies acquired after vaccination or even after infection for certain variants such as variant B.1.351 (beta variant according to the WHO, first detection in South Africa) or variant B.1.617.2. (delta variant according to the WHO, first detection in India). On the other hand, cases of COVID-19 following a full vaccination regimen have recently been reported. With the increasing detection of new variants and in the context of increasing vaccination coverage of the population, one of the priority missions of the National Reference Centre (NRC) for respiratory infection viruses is to clinically and virologically investigate all cases of infection in vaccinated patients. The main objective is to determine whether a particular variant is over-represented in vaccinated patients with an infection. The secondary objective is to study the humoral immune response in COVID-19 vaccinated patients with and without SARS-CoV-2 infection.