title: Study of the Effects of Anticoagulant Interruption Covered by Percutaneous Left Atrial Occlusion in Patients With Chronic Atrial Fibrillation and Radiation Cystitis at Risk of Bleeding

acronym: HEMOCC

summary:
The etiology of the radiation cystitis is a pelvic irradiation generally performed as part of the treatment of prostate cancer. The incidence is 50,000 new cases per year. Approximately 35% of prostate cancer treatment is radiotherapy. The prevalence of haematuric radiation cystitis is 4-5% (about 800 patients).

One of the complications of radiation cystitis is persistent hematuria. There is currently no curative treatment for this hematuria. There are few treatment options with a random probability of improvement of this symptomatology. These haematurias are rarely resolved spontaneously and most of the time involve emergency room management with +/- invasive procedures, sometimes by hospitalisation, always with a significant psychological impact on the patient.

Furthermore, lifetime anticoagulant treatment considerably increases the likelihood of bladder bleeding. This is the case of patients being followed for Atrial Fibrillation Cardiac Arrhythmia (AFCA), which by definition carries a major cardioembolic risk, and who will be of particular interest in this study.

In recent years, cardiologists have developed an alternative to anticoagulants: left atrial appendage closure or left atrial occlusion (LAO) . This procedure consists of inserting a nitinol prosthesis in the left atrium, the site of more than 90% of thrombi formation in non-valvular atrial fibrillation. This minimally invasive procedure lasts about 15 minutes and is performed during a 48-hour hospitalization. Anticoagulants are stopped the day after the setting up procedure. Several studies have shown non-inferiority of atrial closure and anticoagulants to thromboembolic events in non-valvular atrial fibrillation. In addition, LAO allows the permanent discontinuation of anticoagulants, associated with the cessation of anticoagulant bleeding adverse events.

While studies have been conducted on the impact of this technique on patients monitored in cardiology, no studies evaluate the value of LAO in anticoagulated patients with a hematuric radiation cystitis. This tprocedure is already used in routine care for patients followed in urology, and has shown encouraging results, since 8 out of 10 patients saw a significant reduction in the number of haematurias, but it has never yet been scientifically proven to be effective, hence the aim of this study.

The interest of this study will therefore be :

To evaluate the potential benefit of left atrial appendage closure on the number of episodes of hematuria.
To evaluate the economic benefit in reducing the number of hospitalizations, surgeries and complications for hematuria as well as the discontinuation of anticoagulants.

As the patient's data must be retrieved regardless of the patient's subsequent management (with or without a cardiac procedure) within the framework of the HEMOCC protocol, it will be proposed to the patient as soon as he or she is consulting for haematuria on radiation cystitis. The patient will be followed for 3 years.

The mainly descriptive analyses will be collected in the form of a register and carried out by a biostatistician from Clermont-Ferrand University Hospital.


title: Extracellular Vesicles as Biomarkers for Chronic Renal Failure

acronym: VE-IRC

summary: The recent discovery of extracellular vesicles (EV) as a mechanism of intercellular communication has made it possible to develop a new field of health research and could bring new information on the pathological mechanisms of renal diseases. Definition of physiologic and pathologic values of urinary extracellular vesicles (EVu) between healthy subjects and chronic kidney diseases (CKD) patients could be a new tool for follow up of renal diseases. EV are found in all biological fluids including urine, that's why they are increasingly analyzed in renal pathologies. The main objective of this study is to determine the physiological values and the pathological thresholds of EVu.

study_start_date_type: Actual

status: Recruiting

study_completion_date_type: Anticipated

study_type: Interventional

design_allocation: Randomized

primary_purpose: Basic Science

enrollment_type: Anticipated

ipd_sharing: No

lead_sponsor: Centre Hospitalier Universitaire, Amiens

intervention_type: Diagnostic Test

lead_sponsor_type: academique

status_simplified: Ongoing


title: Cardiac Thrombus in Early Cardiac CT Scan in Etiological Workup of Ischemic Stroke: Prospective Study

acronym: CCT STROKE

summary:
Stroke can be linked to atherosclerosis of the large vessels, occlusion of the small intracerebral vessels (gaps), cardioembolic pathology or other rarer etiologies.

The cardioembolic etiology of stroke in elderly patients may be difficult to prove. Paroxysmal atrial fibrillation (AF) is a common cause of cerebral infarction (25%). Detecting AF is not easy. A 24-hour long-term holter and an implantable cardiac monitor (Reveal®) may be required. This etiology is all the more important as it requires anticoagulation treatment reducing the risk of recurrence in the short and long term. The left atrium thrombus is an indisputable marker of atrial fibrillation but it is rarely seen. Other cardiac etiologies such as a thrombus in the left ventricle, a large plaque or a thrombus of the aortic arch are possible. Finally, the permeable oval foramen and the aneurysm of the intra-auricular septum constitute a cause apart in young subjects (<60 years).

Typically, the search for thrombus of the left atrium goes through a trans-thoracic cardiac ultrasound and a transesophageal cardiac ultrasound. These examinations, often negative, are performed several days after the onset of the cerebral infarction. The transesophageal cardiac ultrasound, considered as the "gold standard" examination to look for an intracardiac thrombus and an embologenic plaque in the aortic arch, is poorly tolerated. It is rarely performed in patients over 75 years of age. In addition, the length of stay for these patients may increase due to the wait for these exams.

Several studies have validated the non-inferiority of the cardiac scanner compared to the transesophageal cardiac ultrasound for the detection of intracardiac thrombus (left atrium or left ventricle).

In the study by Hur et al. performed in 55 consecutive patients with a probable cardioembolic infarction, 14 thrombi of the left atrium were detected and confirmed by the cardiac scanner, but the patients were young, with a median age of 61 years. In the Berlin prospective HEBRAS study, 475 patients underwent cardiovascular MRI. The results are being analyzed but the cardiac scanner is more sensitive for the detection of thrombus in the left atrium.

A prospective study confirmed that the cardiac scanner is more precise in differentiating the left atrial thrombus from circulatory stasis in patients with stroke In this study, there is no information on the time between the stroke and the completion of the cardiac scanner.

Almost all patients with stroke benefit from an angio-scan of the CT scan of supra-aortic trunks as part of the urgent assessment on Day 1 or Day 2. The investigators propose to perform at the same time a cardiac scanner in order to allow a rapid morphological cardiological assessment, at the level of the left atrium, the left ventricle and the arch of the aorta.

primary_purpose: Diagnostic

ReferenceType: result

ReferenceCitation: Cresti A, García-Fernández MA, Sievert H, Mazzone P, Baratta P, Solari M, Geyer A, De Sensi F, Limbruno U. Prevalence of extra-appendage thrombosis in non-valvular atrial fibrillation and atrial flutter in patients undergoing cardioversion: a large transoesophageal echo study. EuroIntervention. 2019 Jun 12;15(3):e225-e230. doi: 10.4244/EIJ-D-19-00128.

family: Cresti

full_name: Alberto Cresti

given: Alberto

sequence: first

family: García-Fernández

full_name: Miguel Angel García-Fernández

given: Miguel Angel

sequence: additional

family: Sievert

full_name: Horst Sievert

given: Horst

family: Mazzone

full_name: Patrizio Mazzone

given: Patrizio

family: Baratta

full_name: Pasquale Baratta

given: Pasquale

family: Solari

full_name: Marco Solari

given: Marco

family: Geyer

full_name: Alessia Geyer

given: Alessia

family: De Sensi

full_name: Francesco De Sensi

given: Francesco

family: Limbruno

full_name: Ugo Limbruno

given: Ugo

bso_classification: Medical research

datasource: user

genre: journal-article

genre_raw: journal-article

journal_name: EuroIntervention

publisher: Europa Digital & Publishing

publisher_dissemination: Europa Digital & Publishing

publisher_group: Europa Digital & Publishing

publisher_normalized: Europa Digital & Publishing

ReferenceCitation: Hur J, Kim YJ, Lee HJ, Ha JW, Heo JH, Choi EY, Shim CY, Kim TH, Nam JE, Choe KO, Choi BW. Left atrial appendage thrombi in stroke patients: detection with two-phase cardiac CT angiography versus transesophageal echocardiography. Radiology. 2009 Jun;251(3):683-90. doi: 10.1148/radiol.2513090794. Epub 2009 Apr 14.

family: Hur

full_name: Jin Hur

given: Jin

family: Kim

full_name: Young Jin Kim

given: Young Jin

family: Lee

full_name: Hye-Jeong Lee

given: Hye-Jeong

family: Ha

full_name: Jong-Won Ha

given: Jong-Won

family: Heo

full_name: Ji Hoe Heo

given: Ji Hoe

family: Choi

full_name: Eui-Young Choi

given: Eui-Young

family: Shim

full_name: Chi-Young Shim

given: Chi-Young

full_name: Tae Hoon Kim

given: Tae Hoon

family: Nam

full_name: Ji Eun Nam

given: Ji Eun

family: Choe

full_name: Kyu Ok Choe

given: Kyu Ok

full_name: Byoung Wook Choi

given: Byoung Wook

publisher: Radiological Society of North America (RSNA)

title: Left Atrial Appendage Thrombi in Stroke Patients: Detection with Two-Phase Cardiac CT Angiography versus Transesophageal Echocardiography

ReferenceCitation: Haeusler KG, Grittner U, Fiebach JB, Endres M, Krause T, Nolte CH. HEart and BRain interfaces in Acute ischemic Stroke (HEBRAS)--rationale and design of a prospective oberservational cohort study. BMC Neurol. 2015 Oct 22;15:213. doi: 10.1186/s12883-015-0458-2.

repository_institution: Universitätsbibliothek der Freien Universität Berlin - Refubium

title: HEart and BRain interfaces in Acute ischemic Stroke (HEBRAS) – rationale and design of a prospective oberservational cohort study

ReferenceCitation: Hur J, Kim YJ, Lee HJ, Ha JW, Heo JH, Choi EY, Shim CY, Kim TH, Nam JE, Choe KO, Choi BW. Cardiac computed tomographic angiography for detection of cardiac sources of embolism in stroke patients. Stroke. 2009 Jun;40(6):2073-8. doi: 10.1161/STROKEAHA.108.537928. Epub 2009 Apr 16.

name: From Department of Diagnostic Radiology (J.H., Y.J.K., H.-J.L., T.H.K., J.E.N., K.O.C., B.W.C.), Severance Hospital, Yonsei University College of Medicine, Seoul, South Korea; Division of Cardiology (J.-W.H., E.-Y.C., C.-Y.S.), Yonsei Cardiovascular Center, Yonsei University College of Medicine, Seoul, South Korea; Department of Neurology (J.H.H.), Severance Hospital, Yonsei University College of Medicine, Seoul, South Korea.

publisher: Ovid Technologies (Wolters Kluwer Health)

title: Cardiac Computed Tomographic Angiography for Detection of Cardiac Sources of Embolism in Stroke Patients

ReferenceCitation: Romero J, Husain SA, Kelesidis I, Sanz J, Medina HM, Garcia MJ. Detection of left atrial appendage thrombus by cardiac computed tomography in patients with atrial fibrillation: a meta-analysis. Circ Cardiovasc Imaging. 2013 Mar 1;6(2):185-94. doi: 10.1161/CIRCIMAGING.112.000153. Epub 2013 Feb 13. Review.

name: From the Division of Cardiology and Montefiore-Einstein Center for Heart and Vascular Care, Montefiore Medical Center, Albert Einstein College of Medicine, Bronx, NY (J.R., S.A.H., I.K., H.M.M., M.J.G.); and The Zena and Michael A. Wiener Cardiovascular Institute, Marie-Josée and Henry R. Kravis Center for Cardiovascular Health, Mount Sinai School of Medicine, New York, NY (J.S.).

title: Detection of Left Atrial Appendage Thrombus by Cardiac Computed Tomography in Patients With Atrial Fibrillation

ReferenceCitation: Ajlan AM, Bagdadi RR, Alama MN, Ayoub O. Impact of Implementing Cardiac CT in Evaluating Patients Suspected of Cardioembolic Stroke. J Comput Assist Tomogr. 2016 May-Jun;40(3):380-6. doi: 10.1097/RCT.0000000000000369.

ReferenceCitation: Taina M, Vanninen R, Sipola P, Muuronen A, Jäkälä P, Hedman M. Cardiac CT Differentiates Left Atrial Appendage Thrombi from Circulatory Stasis in Acute Stroke Patients. In Vivo. 2016 09-10;30(5):671-6.

ReferenceCitation: Shankar V, Bangdiwala SI. Observer agreement paradoxes in 2x2 tables: comparison of agreement measures. BMC Med Res Methodol. 2014 Aug 28;14:100. doi: 10.1186/1471-2288-14-100.

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

repository_institution: University of North Carolina at Chapel Hill - Carolina Digital Repository


title: Evaluation of the Efficacy and Tolerance of Plasmapheresis by Double Cascade Filtration in a University Centre

acronym: DFPPSURV

summary: A study is being carried out to evaluate the biological, technical and clinical/biological efficacy of this technique, the practice of which is standardized in the department, in order to evaluate our practices and to improve them if necessary. As part of this study, the investigators will ask all patients scheduled for this procedure to participate in this observational prospective study without changing usual practices.

status: Completed

study_completion_date_type: Actual

study_type: Observational

time_perspective: Prospective

enrollment_type: Actual

lead_sponsor: Centre Hospitalier Universitaire de Nīmes

location_facility: CHU de Nîmes, Hôpital Universitaire Caremeau

status_simplified: Completed


title: Evaluation on Standardized Circuits of the Interest of a Robotic Module of Assistance to the Driving of Patients With Neurological Disorders, in Difficulty Driving of Electric Wheelchairs

summary: The device that is the subject of this investigation is a robotic assistance module for driving a semi-autonomous electric wheelchair. This module is designed to accessorize the electric wheelchair to improve the safety conditions when driving an electric wheelchair, thus reducing the wheelchair accident rate on the one hand and facilitating access to the wheelchair to persons who can not claim it without the use of a safety device of this type.

primary_purpose: Other

lead_sponsor: Pôle Saint Hélier

intervention_type: Device

lead_sponsor_type: industriel


title: Diabetes Screening in Patients on Long-Term Glucocorticoid Therapy

acronym: DIACORT

summary:
Glucocorticoids are widely prescribed in the treatment of many inflammatory, autoimmune or allergic diseases, but also in transplant patients or patients with malignant hematological diseases (leukaemia, lymphoma, myeloma, etc.). They have many side effects, including effects on carbohydrate metabolism.

Corticosteroids are diabetogenic because they disrupt pancreatic insulin secretion and decrease the insulin sensitivity of target tissues (liver, muscle, adipose tissue).

The use of glucocorticoids may lead to the development of corticosteroid-induced diabetes in non-diabetic patients.

Corticosteroid-induced diabetes is frequently found in clinical practice. Incidence figures for corticosteroid-induced diabetes vary widely.

Case-control studies show odds ratios of corticosteroid-induced diabetes onset ranging from 1.36 and 2.23. In two of these studies, the diagnostic criterion was the prescription of a hypoglycemic treatment. Smaller studies, retrospective or prospective, show incidence rates of corticosteroid-induced diabetes ranging from 8.8 to 52%. This difference in incidence rates is explained by the different glucocorticoid doses, glucocorticoid durations, conditions requiring glucocorticoid therapy, and diagnostic criteria for corticosteroid-induced diabetes that vary from study to study. In kidney transplantation, diabetes concerns 16% of patients before the age of 40, and up to 52% after the age of 50. The diagnostic criteria used in the literature are often fasting and post prandial glycemia. The differences in incidence rates found with these two diagnostic methods can be explained by the pharmacokinetics of glucocorticoids. The main glucocorticoids prescribed have a duration of action of 12 to 16 hours. As they are generally prescribed in the morning as a single daily dose, fasting morning blood glucose levels are often normal while postprandial blood glucose levels are increased. This observation has been presented in 2 studies. However, the 2 diagnostic criteria were not statistically compared in these studies.

While according to the American Diabetes Association, the 3 criteria used to diagnose diabetes are fasting glycemia, glycemia 2 hours after an oral glucose load of 75 g and glycated hemoglobin, these last 2 diagnostic criteria are, to the investigator's knowledge, not used in the scientific literature to screen for corticosteroid-induced diabetes.

In current practice, the diagnostic criteria used are disparate. To date, there are no studies that have determined which diagnostic criterion is the most effective in screening for corticosteroid-induced diabetes. The current recommendations recommend early diagnosis and treatment in order to achieve satisfactory glycemic control as quickly as possible. These recommendations have been shown to be effective in reducing the risk of degenerative complications of diabetes, but it is important to screen for corticosteroid-induced diabetes with the most relevant diagnostic criterion in order to optimise its management.

lead_sponsor: Centre Hospitalier Universitaire Dijon


type: Other Identifier

title: Circulating DNA to Improve Outcome of Oncology PatiEnt: A Randomized Study - COPE Study

acronym: COPE

summary:
COPE is a biology driven protocol with 2 independent, multicentric, two-arm non-comparative randomized (2:1) phase II trials in 2 distinct populations: colorectal cancer patients and non-small-lung cancer patients.

For each phase II trial, patient will be randomized between two arms with two patients randomized in arm A for one patient randomized in arm B:

Arm A (Experimental - initial MTB providing therapeutic recommendation based on tumor sequencing and then follow-up combining standard imaging and ctDNA analysis)
Arm B (Standard - initial MTB providing therapeutic recommendation based on tumor sequencing and then follow-up based on standard imaging).

lead_sponsor: Institut Bergonié

intervention_type: Genetic


title: Comparison of Two NGS Phasing Techniques of Parental Haplotypes for NIPD of Triplet Expansion Diseases

summary: The purprose of this study is to develop and validate an analytical NIPD test for triplet repeat disesases by NGS analysis from maternal blood, searching for the familial mutation in families at risk of having one of the following triplet repeat diseases: Huntington's disease, Myotonic dystrophy, Fragile X syndrome.. A comparison of two 3rd generation long fragment DNA sequencing techniques will be performed. These methods are based of the phasing techniques of parental haplotypes without the proband.

status: Active, not recruiting

time_perspective: Retrospective

ipd_sharing: Undecided

ipd_sharing_description: NC

lead_sponsor: University Hospital, Montpellier


title: Development and Evaluation of a Lifestyle Intervention Among Participants of the French Colorectal Cancer Screening Program

acronym: LIFE-SCREEN

summary: The investigators propose a randomized controlled trial to develop and evaluate the impact of promoting advice on diet and lifestyle recommendations for cancer prevention at colorectal cancer screening among individuals who may be at higher risk for colorectal cancer (CRC). The specific objectives of this study are to 1) develop a lifestyle intervention based on evidenced-based diet and lifestyle recommendations (i.e. those proposed by the World Cancer Research Fund (WCRF) and the French National Cancer Institute); 2) evaluate the effect of the intervention on the adherence to the target diet and lifestyle recommendations as well as other subjective health measures, including quality of life; 3) evaluate the effect of the intervention on biological pathways linked to colorectal cancer development including physical fitness, anthropometrics, biomarkers for nutrition, and metabolic health.

study_start_date_type: Anticipated

status: Not yet recruiting

primary_purpose: Prevention

lead_sponsor: International Agency for Research on Cancer

intervention_type: Behavioral


title: BREGS - IL-2 Signaling and Polarization of Regulatory LBs: Involvement in Multiple Sclerosis

acronym: BREGS

summary:
Multiple sclerosis (MS) has long been considered a disease mediated primarily by CD4+ T cells. However, recent clinical trials demonstrating significant efficacy of B-lymphocyte depletive therapies have highlighted the major role of this cell population in the development of MS. Among B-Ls, regulatory ("anti-inflammatory") B-Ls (Bregs) have protective functions in autoimmune diseases including MS, however the mechanisms that regulate the development and function of Bregs are poorly characterized. In our research laboratory (INSERM UMR1236), one of the lines of research focuses on the role of interleukin-2 (IL-2) signaling in the fate of the B lymphocyte. Numerous studies conducted in both human and mouse models of MS demonstrate the major role of this IL-2/IL2R signaling pathway in the pathogenesis of autoimmune diseases.

The hypothesis is that IL-2/IL2R pathway could contribute, by a mechanism intrinsic to B lymphocytes, to the development of autoimmune diseases such as MS.

While a defect in IL-2 signaling plays a critical role in the pathogenesis of MS, the impact of this defective signaling on regulatory B lymphocyte populations, which has been shown to play a protective role in the development of the disease, has never been studied. This study could help establish a new mechanism predisposing patients to develop the disease.

design_allocation: Non-Randomized

lead_sponsor: Rennes University Hospital

intervention_type: Biological


title: Clitoris Potential Analgesic Function Research by Pregnant Women : Feasibility Study

acronym: FAC

summary: Assessment of the acceptability by pregnant women on the research of the potential analgesic function of the clitoris.

lead_sponsor: University Hospital, Rouen

intervention_type: Other


title: Self-identification Based Intervention Targeting Sexual Orientation and Gender Identity

acronym: LGBT

summary:
Despite increased visibility and acceptance of the LGBT community (Lesbian, Gay, Bisexual and Transgender), in some parts of society, many LGBT people struggle with self-acceptance. Minority Stress Theory, described in the scientific literature, explains that health disparities among populations such as the LGBT population can be explained by stressors induced by a hostile, homophobic culture, which results in harm suffered, expectations of rejection, and internalized homophobia. The harm suffered may include acts of discrimination, harassment, violence (physical or linguistic). But more deeply, two important points of this theory: 1) the expectations of the LGBT person to experience rejection based on their identity and the anti-LGBT social stigma, 2) internalized homophobia, which is a social internalization from negativity against homosexuality and transgender to the initial stages of the identity development of an individual who can continue throughout his life. Perceived harm, stigma and lived rejection are associated with an increased propensity to experience significant psychological pain. LGBT people are more likely to develop self-identification based on sexual orientation or gender, making them more vulnerable to any rejection signal.

There is a growing scientific interest around Cognitive and Behavioral Therapies (CBT) of 3rd wave, also called therapies derived from Buddhism, or therapies based on meditation. These programs aim to observe and test, through an experiential meta-cognitive practice, the dogmas or preconceptions (about ourselves, others, and the world) and mental attitudes that guide our choices without our knowledge and are at the origin of suffering, in order to gain inner freedom. These practices constitute an experiential scientific methodology of self-knowledge and reality. These secular programs have become a standard treatment in the management of stress, chronic pain, and the prevention of relapsing depression. In addition, the interest of these practices has been demonstrated in many areas of somatic and psychiatric medicine (including depression and suicidal behavior), but also for the promotion of mental health in the general population. This topic is the subject of more than 15,000 international scientific publications with reading committee (Medline indexed), and of strong interest and shared by both the scientific community and the general public.

Scientists are currently deepening these therapies with a focus on wisdom-based self-identification. Beyond the name "therapies", this educational information is key to life for everyone. Who am I ? Am I defined by my social roles, my physical characteristics, my preferences? How to face external challenges? How to develop real self-confidence?

Dr Déborah Ducasse offers a conference on the theme: "Sexual orientation, gender: where is the problem?" Nowhere. Self-identification. ". This conference will take place on 05/15/2020, on the occasion of World Day Against Homophobia.

In line with the OECD press release in 2019 "The LGBT challenge: how to improve the integration of sexual and gender minorities? "(Panorama de la société 2019: Social Indicators of the OECD), the investigators want to assess whether an intervention targeting valid self-identification can 1) have a positive impact on the acceptance and discrimination indicators of the OECD ; 2) have an impact on valid self-identification.

Direct benefits are expected, psychologically and socially, in the fight against discrimination, inclusion and self-acceptance.

In the medium and long term: major public health interest via the adaptation of psychoeducational interventions based on self-identification in order to prevent psychosocial risks and suicidal behavior in connection with an altered self-identification based on sexual orientation and gender.


title: Rapid Screening for Olfactory Disorders in Covid-19 Infection

acronym: OLFASCAN

summary:
Loss of smell is very frequently found in Europe during Covid-19 attack. This symptom was not initially expected as part of the classic symptomatology. This loss of smell mainly concerns patients with few or no symptoms, without criteria of severity and usually treated on an outpatient basis. As a result, given the unexpected occurrence of this symptom (with less awareness in the general and medical population) and the potential risk of contamination of Covid+ and anosmic subjects (due to their less symptomatic form), it is interesting to be able to propose large-scale screening for loss of sense of smell in order to preferentially direct subjects diagnosed as anosmic towards RT-PCR-type screening. In the medium term, the loss of smell seems to persist after the infectious phase, with delayed or persistent recovery, which can lead to negative psychological repercussions.

The objective is to propose large-scale screening of the general population for loss of sense of smell during a pandemic period, in order to facilitate diagnostic orientation of the population. The diagnosis of loss of smell will be carried out using a simple olfactory test in the form of an olfactory stick to be smelled.

primary_purpose: Screening

lead_sponsor: Centre Hospitalier Universitaire de Nice


title: Water Load Test Value for Hyponatremia Due to a Syndrome of Inappropriate Antidiuresis (SIAD)

acronym: WATERLINE

summary: Acute water load test has been using to diagnose renal ability to excrete water for decades. Latest recommendations for the diagnosis of hyponatremia do not recommend performing such a test. The investigators aim at, retrospectively, study the value of acute water load test in patients suffering from a syndrome of inappropriate antidiuresis.

lead_sponsor: European Georges Pompidou Hospital

location_facility: European Georges Pompidou Hospital, APHP

intervention_type: Procedure


title: Measurements of Sexual Steroids' Concentrations in Prostatic Tissue From Samples Taken by Biopsy Needle on Fresh Operating Parts : Measurements' Reliability

acronym: Pré-HORM

summary:
In the investigators's previous work, measurements of intra-prostatic concentrations of sex steroids were determined on samples taken from the operating room using a punch.

In order to study the in-vivo intra-prostatic concentrations of sex steroid, it is necessary to validate a measurement technique performed on samples obtained by a biopsy needle used in standard care for prostate biopsy punctures allowing the diagnosis and follow-up of prostate cancer.

The aim of this project is to validate this measurement technique carried out on samples obtained by the biopsy needle and to define the optimal number of carrots obtained by biopsy offering dosage results comparable to the punch.

lead_sponsor: Hopital Foch


title: Efficacy of a Multi-faceted Intervention to Deprescribe Proton Pump Inhibitors (PPI) in Primary Care: a Population-based, Pragmatic, Cluster-randomized Controlled Trial.

acronym: DeprescrIPP

summary:
Deprescribing is defined as "the process of withdrawal of an inappropriate medication, supervised by a health care professional with the goal of managing the polypharmacy and improving outcomes". Inappropriate use of proton pump inhibitors (PPI) is associated with severe adverse drug reactions and a major economic impact. Deprescribing should be considered when inappropriate prescription of PPI is identified.

DeprescrIPP is a pragmatic population-based cluster-randomized trial conducted in primary care. It will assess the efficacy and effectiveness of a multi-faceted intervention (on patients and general practitioners) to deprescribe PPI.

primary_purpose: Health Services Research

lead_sponsor: Nantes University Hospital


title: Evaluation of Reporting of AdVerse Events Associated With AnTicAncer theRapy : an Observational and Retrospective Study Using the WHO Pharmacovigilance Database(AVATAR)

acronym: AVATAR

summary: Anticancer drugs can lead to various adverse events. This study analyses reports of adverse events for treatment including Anatomical Therapeutic Chemical (ATC) classification L (antineoplastic agents, endocrine therapy, immunostimulants, and immunosuppressants drugs) in the World Health Organization's (WHO) global database of individual safety case reports (VigiBase).

time_perspective: Cross-Sectional

lead_sponsor: University Hospital, Caen

intervention_type: Drug


title: Effect of Psyllium (Plantago Ovata) on Digestive Disorders in Familial Amyloidosis

acronym: Psyllium

summary:
Familial amyloidosis is a rare disease that mainly affects the nerves and heart, but also more rarely the eyes and kidneys. This disease is due to a mutation in the gene encoding the synthesis of transthyretin, resulting in a modification of the translated protein. This abnormal protein and its derivatives are deposited in the form of a toxic "amyloid" substance in tissues and organs, altering their functions, particularly in the gastrointestinal tract.

From a gastrointestinal perspective, different treatments can be proposed in the absence of specific recommendations for familial amyloidosis. The hygienic and dietary measures consist of avoiding tobacco, alcohol and carbonated drinks, limiting fatty meals rich in poorly digestible fibers, and splitting meals. If this fails, metoclopramide and domperidone are suggested. As a second-line erythromycin, can be used with caution because of cardiac risks and drug interactions. Polyethylene glycol-based osmotic laxatives can be used to treat constipation. Alternating diarrhea and constipation can be treated with ispaghul-based laxatives, aiming at transit regulation. Finally, refractory diarrhea can be treated with the administration of loperamide. If this fails, treatment with a somatostatin analogue may be offered.

However, all these treatments can present significant side effects, therefore natural alternatives are often sought. Psyllium in particular regulates transit by normalizing stool consistency: it is effective against digestive disorders such as constipation, but it is also effective in the event of diarrhea. It allows the formation of a viscous gel by the hydrophilicity of polysaccharides macromolecules, increasing the fecal bowl which stimulates peristalsis and facilitates defecation. The WHO has recognized that Psyllium is superior to wheat bran in the treatment of irritable bowel syndrome.

The main objective of the study is to assess the effect of daily Psyllium administration on digestive quality of life in familial amyloidosis patients who suffer from digestive disorders.

primary_purpose: Treatment

intervention_type: Dietary Supplement


type: EudraCT Number

title: A Single-center, Double-blind for Cenerimod, Open-label for Moxifloxacin, Placebo-controlled, Parallel-group, Randomized Study in Healthy Male and Female Subjects to Investigate I: the Effect of Cenerimod on the QTc Interval II: the Effect of Cenerimod on the Pharmacokinetics of Combined Oral Contraceptives III: the Effect of Charcoal on the Pharmacokinetics of Cenerimod.

summary:
This is a single-center, randomized, double-blind for cenerimod, open-label for moxifloxacin, placebo- and moxifloxacin-controlled, parallel-group study to investigate the effect of cenerimod on the duration of the QT interval in healthy male and female participants.

Participants will be randomly assigned to one of the 4 treatments: placebo, cenerimod 0.5 mg, cenerimod 4 mg or moxifloxacin.

lead_sponsor: Idorsia Pharmaceuticals Ltd.


title: A Prospective Study to Evaluate the Risk of Recurrence of Cervical Artery Dissection During Subsequent Pregnancies

summary: Cervical artery dissection (CAD) accounts for about 2% of all strokes, and is a major cause of stroke in young people (about 15%). Many cases of CAD during pregnancy and puerperium have been described, suggesting that pregnancy and puerperium may be potential risk factors for CAD. The purpose of this study is to determine whether pregnancy and puerperium are also recurrence risk factors for CAD.


title: Evaluation of Optical Pumping Magnetometer Sensors for MagnetoEncephaloGraphy Imaging

acronym: OPM

summary:
This research is a feasibility study on a new generation of brain magnetic activity sensor which should allow the development of this modality, until now limited by its cost to a few large university centers.

The measurement of magnetic activity allows the detection and localization of abnormal activities such as paroxysmal events occurring between seizures in patients with epilepsy as well as research into brain function. It is the only one, along with EEG and related techniques, to provide data related to the speed of the brain. MEG, by virtue of the properties of magnetic fields, has a greater potential than EEG for the detection and localization of the neuronal sources which cause it.

The MEG sensors used until now use Superconducting Quantum Interference Devices (SQUID) components that are extremely sensitive but require complex instrumentation and only operate under superconducting conditions, resulting in prohibitive maintenance and cost.

The alternative could come from a new magnetic activity sensor: the optical pumping magnetometers of the alkaline type.

This preliminary study proposes to compare SQUID sensors with MPO He4 sensors for their ability to detect abnormal activities recorded in epileptic patients. Measurements that cannot be recorded simultaneously Two types of measurement will be compared with the reference that constitutes in-depth recording (Stereotactic-EEG or SEEG) used to precisely define the region of the brain to be resected in order to cure epileptic patients of their seizures.

The expected results are a capacity of this type of sensors to detect epileptic activities equivalent to that of SQUIDs.

lead_sponsor: Assistance Publique Hopitaux De Marseille

location_facility: Department of Epileptology and Cerebral Rhythmology, Hôpital La Timone, APHM


title: Mathematic Modeling at Micro and Macroscopic Level of Primary Central Nervous System Lymphomas (PCNSL)

acronym: LOC-MODEL

summary: We plan to analyze 100 PCNSL homogenously treated with high-dose methotrexate based chemotherapy using NGS of PCNSL samples. We will perform DNA-seq and RNA-seq from tumor samples. This data will be combined with their magnetic resonance imaging (MRI) at different time points: at diagnosis, at the end of the treatment and at disease progression. Among the 100 PCNSL that will be included, 70 will be from a retrospective (training set) from patients included in the French National PCNSL dataset (LOC cohort) and 30 PCNSL from a prospective cohort from patients included in a phase III clinical trial (BLOCAGE, PHRC 2014). On the one hand, we will perform a radiomics analysis (quantitative imaging) using 3D tumor and edema segmentation. This analysis will help us to elucidate the potential correlation of MRI phenotypes and genotype (using high-throughput data). In addition, we will use the radiomics data combined with in vitro and in vivo data (using a mouse model of PCNSL) as well as immunohistochemistry data to obtain a multidimensional mathematical modeling of PCNSL clinical evolution that will allow us to better predict the clinical course of this rare subtype of brain tumor.

time_perspective: Other

lead_sponsor: Assistance Publique - Hôpitaux de Paris


title: Pronostic Factors of Long Term Outcome in Patients With Clubfoot Treated by the Ponseti Method

summary: We aim at finding prognostic factors of long term (after growth) function outcome in patient with clubfoot treated by ponseti method, based on a very complete prospective recording of treatment variables and outcome

lead_sponsor: Hospices Civils de Lyon


title: Identification of Biomarkers in Ischemic Stroke - Clinical Trial

acronym: IBIS-CT

summary: The objective of the study is to determine RNA blood biomarker based on 9 genes already identified in experimental studies, whose expression would be significantly increased in patient with ischemic stroke compared to controls.

ipd_sharing: Yes

ipd_sharing_description: All collected data that underlie results in a publication

lead_sponsor: University Hospital, Brest


title: Adaptation française Des échelles AIDA (Assessment of Identity Development in Adolescence) et LoPF-Q (Levels of Personnality Functioning Questionnaire), Designed to Assess Personality Development in Adolescence.

summary:
The main objective of this study is to develop the French version of the two questionnaires AIDA and LoPF-Q. The secondary objective is to investigate the links between disrupted development of identity and adolescent psychopathology.

To participate in the study, patients will have to complete online or paper versions of the questionnaires AIDA-LoPF and other assessments of personality and general psychopathology (BB5, SDQ). Parents will have to answer complete the parent version of the SDQ questionnaire. The BPFSC-11, which is a clinician-rated assessment, will be completed in a subgroup of patients, by the same healthcare professional, in order to assess the concurrent validity. The investigators will also add the clinical diagnoses according to ICD-10 found in the medical record.


title: Atropine 0.01% Eyedrops for Evolutive Myopia Treatment in Children. MYOPSTOP

summary:
Prevalence of myopia and its complications has been increasing over the past decades, especially among children and adolescents. It reaches record levels in Asia: nearly 80% of the population in some regions in 2012 where the investigators speak in terms of epidemic.

ATROPINE 0.01% eyedrops one drop per day is today an evolutive myopia treatment, whose results are promising.

The investigators use this eye drops in our clinical practice at hospital of Saint-Etienne since 2017.

Few clinical data have been published so far concerning the French population.

The investigators would like to build a database so that the investigators can publish our results and share our experience.

lead_sponsor: Centre Hospitalier Universitaire de Saint Etienne


title: Prostate Biopsies With Target Lesion on MRI : When Can Non-targeted Biopsies be Dispensed With

summary: Our objective is to search for clinical, biological and imaging element that would better define the patient population that could benefit from targeted prostate biopsies only (from a cohort of patients who had targeted and non-targeted prostate biopsies).


title: Study "HEMORROIDAL SURGERY AND Chronic Inflammatory Bowel Disease"

acronym: CHRMICI

summary:
Hemorrhoidal surgery is considered potentially harmful in patients with chronic inflammatory bowel disease (IBD). Patients with Crohn's disease may have ano-perineal involvement during the course of the disease or even before diagnosis. In addition, patients with IBD (Crohn's or RectoColitis Haemorrhagic, UC) may have rectal involvement. In both cases, hemorrhoidal surgery can be harmful to the anorectal level. However, recent data from the literature has proven to be reassuring. Indeed, the latest studies published on this subject have shown that hemorrhoidal surgery can be performed in a large majority of patients with IBD, especially when the disease is quiescent.

The main objective is to assess the morbidity of hemorrhoidal surgery in IBD patients who have been operated on at our center. Postoperative complications will be the main elements sought in the study.

The secondary objective is to search for predictive factors of complications from hemorrhoidal surgery in patients with IBD. This requires an exhaustive collection of clinical data.

ReferenceCitation: Cracco N, Zinicola R. Is haemorrhoidectomy in inflammatory bowel disease harmful? An old dogma re-examined. Colorectal Dis. 2014 Jul;16(7):516-9. doi: 10.1111/codi.12555. Review.

name: Department of General Surgery; Sacro Cuore Don Calabria Hospital; Negrar Verona

family: Cracco

full_name: N. Cracco

given: N.

name: Department of Emergency Surgery; Parma University Hospital; Parma Italy

family: Zinicola

full_name: R. Zinicola

given: R.

journal_name: Colorectal Disease

publisher: Wiley

publisher_dissemination: Wiley

publisher_group: Wiley

publisher_normalized: Wiley

ReferenceCitation: Jeffery PJ, Parks AG, Ritchie JK. Treatment of haemorrhoids in patients with inflammatory bowel disease. Lancet. 1977 May 21;1(8021):1084-5.

ReferenceCitation: McKenna NP, Lightner AL, Habermann EB, Mathis KL. Hemorrhoidectomy and Excision of Skin Tags in IBD: Harbinger of Doom or Simply a Disease Running Its Course? Dis Colon Rectum. 2019 Dec;62(12):1505-1511. doi: 10.1097/DCR.0000000000001524.

family: McKenna

full_name: Nicholas P. McKenna

given: Nicholas P.

family: Lightner

full_name: Amy L. Lightner

given: Amy L.

family: Habermann

full_name: Elizabeth B. Habermann

given: Elizabeth B.

family: Mathis

full_name: Kellie L. Mathis

given: Kellie L.

journal_name: Diseases of the Colon & Rectum

publisher_dissemination: Wolters Kluwer Health

publisher_group: Wolters Kluwer Health

publisher_normalized: Wolters Kluwer Health

ReferenceCitation: Lightner AL, Kearney D, Giugliano D, Hull T, Holubar SD, Koh S, Zaghiyan K, Fleshner PR. Excisional Hemorrhoidectomy: Safe in Patients With Crohn's Disease? Inflamm Bowel Dis. 2020 Aug 20;26(9):1390-1393. doi: 10.1093/ibd/izz255.

name: Department of Colorectal Surgery, Digestive Disease Surgical Institute, Cleveland Clinic, Cleveland, OH

full_name: Amy L Lightner

given: Amy L

family: Kearney

full_name: David Kearney

given: David

family: Giugliano

full_name: Danica Giugliano

given: Danica

family: Hull

full_name: Tracy Hull

given: Tracy

family: Holubar

full_name: Stefan D Holubar

given: Stefan D

name: Division of Colon and Rectal Surgery, Cedars-Sinai Medical Center, Los Angeles, CA

family: Koh

full_name: Sharon Koh

given: Sharon

family: Zaghiyan

full_name: Karen Zaghiyan

given: Karen

family: Fleshner

full_name: Phillip R Fleshner

given: Phillip R

journal_name: Inflammatory Bowel Diseases

publisher: Oxford University Press (OUP)

publisher_dissemination: Oxford University Press

publisher_group: Oxford University Press

publisher_normalized: Oxford University Press

title: Excisional Hemorrhoidectomy: Safe in Patients With Crohn’s Disease?

lead_sponsor: Groupe Hospitalier Paris Saint Joseph


title: EXOMEDIANE - Retrospective Study Using High Throughput Sequencing (HTS) on Biological Samples to Improve Genetic Counseling for Patients With Previously Explored Craniofacial Midline Defects.

acronym: EXOMEDIANE

summary:
Holoprosencephaly, or HPE, is the most common congenital cerebral malformation in humans and the most severe of a group of pathologies related to a deficiency of the SHH signalling pathway (Sonic Hedgehog SHH-D). It is characterized by severe cerebral and craniofacial abnormalities.

The regulation of SHH concentration is therefore crucial for correct craniofacial development.

Despite the recent identification of about 20 genes, 70% of cases of EHPE and craniofacial midline abnormalities of genetic origin do not have a molecular diagnosis. It is therefore important to continue the search for new candidate genes to improve the understanding of brain and facial development and to improve genetic counseling for these families.

The development of Next-Generation Sequencing (NGS) technologies opens up the possibility of studying the exome or even the genome in a single manipulation. The latter type of analysis is particularly well suited to the discovery of new genes and will therefore improve the care of patients and their families.


title: Cerebal Hemodynamics and Oxygenation in Critically Ill Patients : Characterization and Effects of Therapeutics

summary: Critically-ill patients frequently experience marked changes in mean arterial pressure and carbon dioxide partial arterial pressure, the two major determinants of the cerebral blood flow. In addition, many therapeutics (fluids, vasopressors or inotropes administration, blood transfusion, prone positioning...) can influence these two determinants of cerebral blood flow and thus cerebral blood flow, especially in patients with altered cerebral autoregulation. Nevertheless, cerebral hemodynamics and oxygenation, as well as the effects of the different therapeutics on it have been poorly studied in critically-ill patients. In addition, it has been suggested that impaired cerebral blood flow and impaired cerebral microcirculation may be involved in the pathophysiology of septic encephalopathy in patients with sepsis and/or septic shock. In this study, we aimed to characterize and investigate the effects of different therapeutics on cerebral hemodynamics and oxygenation in critically-ill patients.

ipd_sharing_description: no data sharing plan is planned


title: The E-consult Application for Patients With Breast Cancer: Interest in Empathy and Empowerment of Patients.

acronym: e-CONSULT

summary: Demonstrate that the use of this application in consultation could improve the empathy perceived of the doctors by the patients after the consultation.

lead_sponsor: Centre Francois Baclesse


title: Biological Material Bank for Studies Related to Organ Transplantation

summary:
This study aims to constitute a collection of biological materials from in transplant patients and to provide biological materials from transplanted patients in order :

i) validate new theory on the cause of allograft loss, ii) develop innovative biomarker for rejection and other transplantation-related conditions (such as BK virus nephropathy, Post-transplant lymphoproliferative disorder ( PTLD) ...)


title: Effect of Neurodynamic Mobilization Techniques on Knee Extension Range of Motion of Asymptomatic Young Students: a Prospective, Comparative Study.

acronym: SPEAKER

summary:
Background: The neurodynamics technique seems interesting for increased lower limb flexibility of the lower limbs in healthy subjects. The objective of this study is to assess the physiological effects of the SLUMP sliding technique on the range of knee extension during the SLUMP test.

Methods: 60 physiotherapy students perform measurements during three tutorials. The first involves training in evaluation techniques. The second involves mobilizing the knee, out of the SLUMP position. The third tutorial includes neuronal mobilization in SLUMP.

Knee extension in SLUMP position is measured immediately after completing techniques. The mobilization amplitudes (degrees) will be compared between the techniques by a Student test on paired series, each subject being his own control.

Discussion: The results of this study will provide evidence for the physiological effect of SLUMP sliding techniques performed by physiotherapy students on the range of knee extension during the SLUMP test in asymptomatic subjects.


title: Interest of Adding Neuromuscular Electrical Stimulation for Quadriceps Femoris and Triceps Surae Muscles to Pulmonary Rehabilitation in COPD : Randomized Clinical Trial

acronym: COMBIELEC

summary:
Patients with COPD frequently have muscle disorders. Pathogenic mechanisms generate significant pathophysiological changes in the locomotor muscles structure, leading to decreased strength, decreased endurance and limited exercise capacity.

Pulmonary rehabilitation is the first choice therapy and training overall lower limb endurance is a priority. Even if the effects of pulmonary rehabilitation are no longer to be demonstrated, it is still necessary to optimize the modalities of muscular strengthening. In fact, it is recommended to associate to this global endurance training a specific strengthening of the muscles of the lower limbs. Neuromuscular electrostimulation (NMES) is a muscular strengthening technique, but this method is not used in usual practice in pulmonary rehabilitation and often only the quadriceps are concerned. In a pulmonary rehabilitation program, including sessions of NMES of the quadriceps femoris and triceps surae could increase its effectiveness.

Recent studies suggest that NMES can improve muscle function, exercise tolerance, dyspnea and quality of life in COPD patients.

A pilot study compared the effects of the combined quadriceps femoris and triceps surae versus quadriceps alone. The final evaluation showed a greater improvement in exercise capacity in favour of the combined NMES group. Only two studies with small numbers of patients evaluated the effect of combined quadriceps femoris and triceps surae NMES in pulmonary rehabilitation, with encouraging results in terms of functional gain. Further larger studies seem necessary to evaluate the effects of combined quadriceps femoris and triceps surae NMES in pulmonary rehabilitation. The objective of the study is to show that combined quadriceps femoris and triceps surae NMES during a pulmonary rehabilitation program provides a more significant improvement in exercise capacity compared to a standard pulmonary rehabilitation program.


title: Evaluation of Iodine Supplementation in Women With Pregnancy Associated With Gestational Diabetes

acronym: IODIAB

summary: Iodine supplementation during pregnancy is recommended by the high health authority and by the World Health Organization during pregnancy. We would like to know if this supplementation is prescribed in a manner consistent with the recommendations in women diagnosed with gestational diabetes.

lead_sponsor: Centre Hospitalier Sud Francilien


title: Spinal Cord Stimulation for Gait Disorders in Parkinson's Disease: a Pilot Study

acronym: SCM-PARK

summary:
Our project is based on the fundamental hypothesis that epidural spinal cord stimulation (SCS) improves Freezing of gait (FOG) in patients with Parkinson's disease. In eight patients implantation of electrodes for SCS at the epidural thoracic level will be performed under general anaesthesia.

Evaluation of gait and motor symptoms will be performed with and without stimulation, after a 3-month period for each of the stimulation conditions.This is a pilot, single centre, prospective, randomized, double blinded, cross-over study.

lead_sponsor: University Hospital, Grenoble


title: Venous Congestion and Organ Dysfunction in Intensive Care: a Prospective, Multicenter, Observational Study to Evaluate Prevalence and Risk Factors.

acronym: CoDoRéa

summary:
Venous congestion, which is a phenomenon described in cardiology and post-operative cardiac surgery, is responsible for an increase in morbidity and mortality.

Indeed, it can lead to kidney failure, liver failure, prolonged ileus, scarring complications, and neurological disorders. Clinical and ultrasound indications have been described to diagnose this condition.

To date, this phenomenon is poorly known and not described in intensive care patients outside the cardiac context. However, intensive care patients can present the risk factors associated with the occurrence of congestion: acute cardiac failure, significant water-salt overload, and/or fluid distribution anomalies. Thus, observational studies have found an association between the input-output balance, the quantity of salt-water intake, the presence of right heart dysfunction and the occurrence of acute kidney failure, digestive disorders, hypoxemia and a prolonged stay in intensive care. The presence of a congestive condition is medically treatable since diuretic decongestion is associated with improved cardiac outcomes.

It is therefore necessary, in an intensive care context, to be able to define and diagnose this state of venous congestion, to study its prevalence, and to confirm the existence of a link with organ failure in order to pave the way to known adapted treatment options.

lead_sponsor: Centre Hospitalier Universitaire Dijon


title: Defining the Severe Paediatric Asthma Endotype: an Integrated Approach Combining Phenotypic Analyses Related to Immune, Metabolomics and Microbial Features

acronym: SevAsthma

summary: The primary objective of this project is to extensively characterize the endotypes of pre-schoolers (0 to 6 years) and school-age children (6 to 12 years) with SA using an integrated approach, combining a description of their phenotype (asthma symptoms, atopy, and lung function) associated with histological (airway inflammation and remodelling), immune (innate and adaptive immunity), metabolomics, and microbiota analyses. This goal shall be achieved by an unsupervised in-depth analysis of patients requiring bronchial endoscopy, with bronchial alveolar lavage (BAL) and bronchial biopsy, as part of their clinical assessment.


title: Prognostic Evaluation of COVID-19 in Rheumatoid Arthritis Patients : ProCOVRA

acronym: ProCOVRA

summary: COVID-19 is an infectious disease caused by SARS-CoV2 virus. The objective of our study is to analyze the progression and the severity of COVID-19 in patients with RA. Indeed, few data are available on this subject, and this would allow us to improve management of COVID-19 in these potential at-risk patients.

lead_sponsor: University Hospital, Montpellier


title: Validation Study of the ALYATEC Allergen Exposure Chamber (EEC) by Determining the Concentration of Cat Allergen Inducing Early and/or Late Bronchial Response in Asthmatic Subjects Allergic to Cat

summary:
This is a randomized, double blind, cross-over study designed to determine the concentration of airborne cat allergen inducing bronchial response in asthmatic subjects allergic to cat, during allergen exposures in the Alyatec environmental exposure chamber (EEC).

The study was also designed to validate the specificity of the asthmatic reaction induced by exposure to airborne cat allergen in Alyatec EEC.

lead_sponsor: Alyatec


title: Comparison Between Continuous Positive Airway Pressure (CPAP) and Non Invasive Positive Pressure Ventilation (NiPPV) in Bronchiolitis Under Non- Invasive Ventilation

acronym: BRONCHIO-VNI

summary:
Severe acute viral bronchiolitis is the leading cause of pediatric intensive care admission. The first-line recommended ventilation support is continuous positive airway pressure (CPAP), which reduces the work of breathing (WOB) and improves gas exchange. Although Non invasive Positive Pressure Ventilation (NiPPV) is increasingly used in case of CPAP failure to avoid intubation, no study has yet evaluated if this support could effectively reduce the effort of breathing.

Our hypothesis is that NiPPV could reduce WOB more effectively than CPAP alone, and might lead to reduce intubation in the most severe bronchiolitis.

The purpose of this study is to compare WOB between CPAP and NiPPV, thanks to esophageal pressure measurement, in infants hospitalized for severe acute bronchiolitis.


title: Impact of Microphone Positioning on Auditory Performance in Cochlear Implant Users

acronym: MICLO

summary:
The construction of our auditory space requires several prerequisites, including localization abilities in 3D (azimuth, elevation and distance). These abilities rely on the proper development and functionality of the auditory system to extract various acoustic cues from our environment. Extraction and analysis of these auditory cues are based on the synchronous use of ears, called binaurality. Other natural behaviours are useful to precisely determine the location of a sound source: visual information and head movements.

The slightest anatomical-functional change (e.g. unilateral hearing loss, malformation of the pinna) can disturb spatial hearing abilities. Many patients with hearing loss are fitted with a hearing aid (HA) or a cochlear implant (CI) to ensure the best speech understanding. However, this auditory rehabilitation remains insufficient to restore a good perception of spatial hearing. One of the key point to improve sound localization seems to be microphone positioning on hearing aids. Several questions remain on the optimal microphone positioning.


title: Risk Benefit Ratio of Hirudotherapy: Retrospective Single-center Study of 37 Cases Over a Period of 9 Years

acronym: AMLEE

summary:
Venous congestion in transplanted or re-implanted tissues remains a common and chal-lenging complication in plastic and reconstructive surgery. Local application of medicinal leeches is effective to reduce postoperative venous congestion of the flap and to restore normal blood flow. However, leech therapy is associated with a number of risks, including infections. Indeed, leeches maintain a symbiotic relationship with Aeromonas species in order to digest blood in their gut. Aeromonas spp. infections can occur 1 to 30 days post-application of leeches and are associated with a dramatic decrease in flap salvage rates (88 to 30%). For these reasons, prophylactic antibiotics and, external decontamination are widely recommended throughout the course of leech therapy.

The aim of this study is to investigate the prevalence of side effects (anemia and infection) from patients treated with leeches in French Hospital.

lead_sponsor: Centre Hospitalier Universitaire, Amiens


title: Feasibility of an Acute Physical Exercise Before Immunotherapy and Chemotherapy Infusion for Metastatic Non-small-cell Lung Cancer Patients: Protocol ERICA Study

acronym: ERICA

summary: Because of metastatic Non-Small Cell Lung Cancer (mNSCLC) and its treatments, patients suffer from numerous symptoms such as dyspnea, muscle atrophy, pain, fatigue, loss of appetite, altered physical condition and lung function, which may further impair the patient's overall condition. Nevertheless, it has been suggested that physical exercise could improve response to treatment at the clinical level due to its known effects on the immune system. Moreover, preclinical studies have shown that exercise performed during chemotherapy administration could result in physiological benefits such as improved intra-tumoral infusion and drug delivery. The ERICA study aims to assess the feasibility of an acute physical exercise immediately before immunotherapy and chemotherapy administration in patients with mNSCLC.

primary_purpose: Supportive Care

lead_sponsor: Centre Leon Berard


title: Prospective Evaluation of the Impact on Patients' Quality of Life of a 12-Week Adapted Physical Activity Program (APA) at Institut de Cancerologie de l'Ouest (ICO)

acronym: APA

summary: The objective of this study is to evaluate the effects of regular physical practice on fatigue, quality of life and kinesiophobia in patients treated at the ICO in Angers, regardless of the type of cancer and the type of treatment.

lead_sponsor: Institut Cancerologie de l'Ouest


title: NEUROKINASE : Expression Profile of ERK5 and PKM2 Kinases in Neuroinflammatory Diseases.

acronym: NEUROKINASE

summary:
Demyelinating diseases represent a broad spectrum of disorders and are induced by excessive inflammation most often triggered by an autoimmune mechanism. Some of these pathologies are chronic and affect the central nervous system such as multiple sclerosis (MS), others are monophasic and target the peripheral nervous system such as Guillain Barré syndrome (GBS).

In neuroinflammatory pathologies, the excessive response of the pro-inflammatory Th1 and Th17 lymphocyte lines and the insufficient response of regulatory T lymphocytes (Treg) cause excessive inflammation which is deleterious to the nervous tissue. The regulation of these signaling pathways involves key proteins such as kinases. Modulation of these kinases which could allow the development of new pharmacological targets for neuroinflammation.

Recent work (unpublished data) has shown an association between the expression of ERK5 and PMK2 kinases, and the clinical severity of experimental allergic encephalomyelitis, a mouse model that mimics multiple sclerosis.

In order to search for new biomarkers and improve our knowledge of the actors of the initial inflammatory phase of neuroinflammatory pathologies, we propose to study the differences in expression of ERK5 and PKM2 kinases in the blood and cerebral spinal fluid (CSF) of patients followed for relapsing-remitting MS and GBS by both RT-qPCR and protein quantification. We also want to study other biological parameters which include characterization of the pro / anti-inflammatory balance by cytokine assay and lymphocyte phenotyping, metabolome study, and mild form neurofilament (NfL) assay.

ReferenceType: background

ReferenceCitation: Gaetani L, Salvadori N, Lisetti V, Eusebi P, Mancini A, Gentili L, Borrelli A, Portaccio E, Sarchielli P, Blennow K, Zetterberg H, Parnetti L, Calabresi P, Di Filippo M. Cerebrospinal fluid neurofilament light chain tracks cognitive impairment in multiple sclerosis. J Neurol. 2019 Sep;266(9):2157-2163. doi: 10.1007/s00415-019-09398-7. Epub 2019 May 25.

ReferenceCitation: Kamil K, Yazid MD, Idrus RBH, Das S, Kumar J. Peripheral Demyelinating Diseases: From Biology to Translational Medicine. Front Neurol. 2019 Mar 19;10:87. doi: 10.3389/fneur.2019.00087. eCollection 2019. Review.

ReferenceCitation: Khalil M, Teunissen CE, Otto M, Piehl F, Sormani MP, Gattringer T, Barro C, Kappos L, Comabella M, Fazekas F, Petzold A, Blennow K, Zetterberg H, Kuhle J. Neurofilaments as biomarkers in neurological disorders. Nat Rev Neurol. 2018 Oct;14(10):577-589. doi: 10.1038/s41582-018-0058-z. Review.

ReferenceCitation: Kuhle J, Plattner K, Bestwick JP, Lindberg RL, Ramagopalan SV, Norgren N, Nissim A, Malaspina A, Leppert D, Giovannoni G, Kappos L. A comparative study of CSF neurofilament light and heavy chain protein in MS. Mult Scler. 2013 Oct;19(12):1597-603. doi: 10.1177/1352458513482374. Epub 2013 Mar 25.

ReferenceCitation: Rostami A, Ciric B. Role of Th17 cells in the pathogenesis of CNS inflammatory demyelination. J Neurol Sci. 2013 Oct 15;333(1-2):76-87. doi: 10.1016/j.jns.2013.03.002. Epub 2013 Apr 8. Review.

ReferenceCitation: Thompson AJ, Banwell BL, Barkhof F, Carroll WM, Coetzee T, Comi G, Correale J, Fazekas F, Filippi M, Freedman MS, Fujihara K, Galetta SL, Hartung HP, Kappos L, Lublin FD, Marrie RA, Miller AE, Miller DH, Montalban X, Mowry EM, Sorensen PS, Tintoré M, Traboulsee AL, Trojano M, Uitdehaag BMJ, Vukusic S, Waubant E, Weinshenker BG, Reingold SC, Cohen JA. Diagnosis of multiple sclerosis: 2017 revisions of the McDonald criteria. Lancet Neurol. 2018 Feb;17(2):162-173. doi: 10.1016/S1474-4422(17)30470-2. Epub 2017 Dec 21. Review.

ReferenceCitation: Venken K, Hellings N, Thewissen M, Somers V, Hensen K, Rummens JL, Medaer R, Hupperts R, Stinissen P. Compromised CD4+ CD25(high) regulatory T-cell function in patients with relapsing-remitting multiple sclerosis is correlated with a reduced frequency of FOXP3-positive cells and reduced FOXP3 expression at the single-cell level. Immunology. 2008 Jan;123(1):79-89. Epub 2007 Sep 25.

ReferenceCitation: Yuan A, Rao MV, Veeranna, Nixon RA. Neurofilaments and Neurofilament Proteins in Health and Disease. Cold Spring Harb Perspect Biol. 2017 Apr 3;9(4). pii: a018309. doi: 10.1101/cshperspect.a018309. Review.

lead_sponsor: Centre Hospitalier Régional d'Orléans


title: Neurosensorial Disorder and Pain in Oral Cavity and Oropharynx Cancer Traited Patients

acronym: OCAPA

summary:
Following preliminary studies carried out in our department on these subject and subjective findings during clinical examinations, it has been shown that pain is a symptom that is rarely reported following treatment. Instead, neurosensory disorders such as hypoesthesia and paresthesia are found.

The objective of the study is to map and qualitatively evaluate neurosensory disorders in patients treated for cancers of the oral cavity and oropharynx.

lead_sponsor: University Hospital, Clermont-Ferrand


title: Validation of the Measurement of the Strength of the Posterior Tibial Muscle by Hand-held Dynamometer Against a Reference Isokinetic Dynamometer

acronym: TPHHD

summary:
Adult flat foot valgus is a degenerative pathology that causes damage to the ligaments of the hindfoot as well as dysfunction of the tendon of the posterior tibial muscle.

Currently, there is a lack of a tool allowing a standardized, reliable, reproducible and validated measurement of the strength of the tendon of the posterior tibial muscle in consultation of foot surgery.

The hand-held dynamometer could be that tool. The study would consist in measuring the strength of the tendon of the posterior tibial muscle in healthy subjects with a hand-held dynamometer (MicroFET2) by two examiners and compared to isometric reference measurements (CON-TREX CMV Multi-Joint) to validate the reliability of the measurement and its reproducibility.

lead_sponsor: University Hospital, Lille

location_facility: Hop Salengro - Hopital B Chr Lille - Lille


type: Registry Identifier

title: Long-term Outcomes in Terms of Disability and Quality of Life for Patients Undergoing Posterior Cranial Fossa Craniectomy in the Context of Compressive Cerebellar Hematoma

acronym: CHANCE

summary:
Posterior cranial fossa craniectomy has been shown to improve patient survival. The level of autonomy, disability and quality of life of survivors has been little studied and still underresearched,.

In this context, an assessment of the level of disability and of the quality of life after performing a posterior craniectomy seems relevant.


title: IPrognostic Impact of the Nutritional Status of Individuals Aged 70 Years and Older With SARS-CoV-2

acronym: CodePRONUT

summary: Mortality due to Covid-19 is much higher in the elderly. There are several reasons for the vulnerability of the elderly to the coronavirus: a less efficient immune system, underlying chronic conditions, less protected living conditions. They may also present a poor nutritional state and/or degraded metabolic reserves aggravating an underlying state of frailty. The prevalence of the risk of undernutrition in elderly patients with COVID-19 is high. The evolution of the nutritional status of people aged 70 years or older infected with SARS-Cov-2 is not yet well known. The prognosis of these patients could depend on their nutritional status at the time of the disease. In view of the lack of data, it would be interesting to compare the risk of mortality based on nutritional status in individuals with vs. those without COVID-19.


title: Qualitative Study of the Effect of Interactive Music on the " Child Centered Care Theory " During Dressing Changes in Children.

acronym: MUSIQ

summary:
Dressing repairs cause distress and pain in children. Although drug analgesia is commonly used, some young children experience pain, distress and agitation.

In these cases, the practice of care is not in line with a child-centred approach (CCC). In addition, the use of non-pharmacological methods is recommended to optimize a child procedural pain management . In addition, the use of non-pharmacological methods is recommended to optimize a child procedural pain management in pediatrics. For this reason, interactive music can be proposed during the course of care. We suggest that interactive music transforms behaviour, attitudes, beliefs and convictions of the child, parents and caregivers during the dressing process, thereby altering the perception of pain and the overall experience of care.

The aim of this qualitative study is to explore what happens when children receive dressings in the presence of a musician trained in interactive music distribution in a hospital. Qualitative data will be generated through observation of clinical procedures by non-participant observers (n25) and semi-structured interviews with the musician, healthcare professionals, parents and children to explore this phenomenon from the participants' perspective. The data will be analysed by constant comparison. We will examine the actions, inactions and interactions of healthcare professionals, parents and children during dressing changes through the central theoretical concept of 'Child Centered Care'.

lead_sponsor: Assistance Publique - Hôpitaux de Paris

location_facility: Hôpital Saint Antoine Coordination générale des soins


title: Cost-utility Analysis of Fenestrated Aortic Stents Versus Open Surgery for the Treatment of Complex Abdominal Aortic Aneurysms: a Prospective Multicenter Comparative Cohort Study

acronym: ORFEVAR

summary:
Introduction: Complex abdominal aortic aneurysms (CAA) are defined as abdominal aneurysms that are anatomically unsuitable for a standard endovascular repair because of a short infrarenal neck or no infrarenal neck. These CAAA are usually treated either by fenestrated endovascular aortic repair (FEVAR) or open repair (OR). Data comparing these thechniques remain scarce, mainly consisting of systematic reviews based on retrospective studies. Although mid-term and long-term results remain uncertain, FEVAR has gained widespread acceptance in the vascular community. However, this practice is not evidence base. Beyond clinical results, whether FEVAR is cost-effective or not is not demonstrated. A randomized controlled trial comparing FEVAR and OR is unlikely to be conducted since centers have developed specific expertise and practice, and most of surgeons are not keen to randomize patients. Thus, we believe that a prospective comparative multicentric cohort, with a propensity score and minimization of selection, classification and confusion bias is the most realistic way to provide reliable comparative data on cost effectiveness of FEVAR and OR. Overall, 382 patients are expected to be included (159 in each group).

Objective: The objective of this prospective non-randomized comparative multicenter cohort study is to compare the cost effectiveness incremental ratio at 36 months of FEVAR and OR for CAAA.

Method: Patients with CAAA discussed for FEVAR or OR in 37 french vascular centers in during a two years inclusion period constitute the population study. Preoperative and postoperative clinical and imaging data will are collected prospectively in eCRF forms. QOL before and after treatment is assessed by the E5D5L. The follow-up period is three years. The primary outcome is the Incremental cost-utility ratio (cost/QALY) at 36 months. We plan to minimize indication biases by using a proposensity score (proposnsity score maching and Inverse probablility of treatment weighting) based on clinical and anatomic characteristics. Patient at prohibitive risk for OR are excluded. Patient anatomically unsuitable for FEVAR are also excluded .

Conclusion: This study should provided valuable data on cost effectiveness of FEVAR for CAAA. Sub-goup analysis will be also conducted.

location_facility: Assistance Publique Hôpitaux de Paris - CHU HENRI MONDOR


title: Study of Complications Related to Treatments in Adults Aged 18 to 65 Years Old Responding to a First Treatment in Oncology or Onco-hematology and Participating in the PASCA (PArcours de Santé au Cours du CAncer) Post-treatment Program.

acronym: PASCA

summary:
INTRODUCTION: Approximately 44% of cancer survivors experience a deteriorated quality of life 5 years after diagnosis due to late onset of complications related to cancer treatments. The objective of the study is to evaluate the incidence rates of treatment-related complications, identify sub-clinical abnormalities and risk factors in patients participating in the PASCA post-treatment program.

METHOD: PASCA is a single-center, interventional cohort study of adult patients who received at least chemotherapy and with a complete remission to a testicular germ cell tumor, primary non-metastatic invasive breast carcinoma, high-grade soft tissue sarcoma, osteosarcoma, Ewing's sarcoma, acute myeloid leukemia, Hodgkin's or aggressive non-Hodgkin's lymphoma. Four assessment visits will be scheduled at 1 month (T1), 6 months (T2), 24 months (T3) and 60 months (T4) after completion of treatment. During these visits, 22 complications will be screened and follow-up care will be systematically offered to the health professional concerned by the complication in case of a positive result. The screening will contain the following elements: screening self-questionnaires, quality of life questionnaire, 12 biological parameters, a urinalysis evaluating hematuria, proteinuria, and leukocyturia, a spirometry, an electrocardiogram, 5 tests evaluating physical condition, vital signs and the perimetric measurement between both arms.

DISCUSSION: This systematic screening could highlight a number of complications occurring after cancer treatments. Sub-clinical abnormalities and new risk factors could also be identified. This new organization of care could improve the quality of life of adult cancer survivors.


title: Efficiency of the Quadratus Lumborum Block for Post-operative Analgesia in Abdominoplasty Surgery

acronym: QLB

summary:
Abdominoplasty is a common surgical procedure in plastic surgery which causes postoperative pain and may delay patients' recovery. Surgery is potentially associated with a number of postoperative complications, whether cardiovascular, respiratory, infectious, thromboembolic, or digestive … Although they do not inevitably lead to a life-threatening prognosis, in many cases these complications delay post-operative recovery. Defined in the 1990s by Professor Henry Kehlet's Danish team, rapid rehabilitation after planned surgery is an approach to overall patient care that aims to rapidly restore previous physical and mental capacities and thus significantly reduce mortality and morbidity. Pain management is at the heart of this program and local anesthesia techniques are at the heart of early rehabilitation programs.

Described for just over a decade, Quadratus Lumborum Block (QLB) have shown their effectiveness for analgesia in abdominal, or orthopedic, or obstetrical surgery. Considering the anatomical territory concerned, this locoregional anesthesia technique seems to be very interesting in abdominoplasty to allow early rehabilitation of the patient.


title: Role of the Microbiota in the Evolution of the SARS-CoV-2 Disease in Hospitalized Patients

acronym: MicrobioCOVID

summary:
Patients hospitalized for COVID-19 may need intensive care (e.g. mechanical ventilation) during hospitalization. Some risk factors are already known but better targeting of such patients is still needed, at least because existing risk factors are not strong enough to provide an accurate prediction. Care organization would benefit for such a predictive tool.

Oropharyngeal and gut microbiota could potentially fill a significant gap in predictive performances. The investigators therefore propose to sample 200 patients (oropharyngeal and rectal swab) admitted in infectious disease department at Bichat Hospital and at high risk of needing intensive care during hospitalization. The investigators plan to perform metagenomic sequencing and bioinformatic analysis of these samples to characterize the diversity of bacterial species present in the oropharynx and the gut and to identify new factors associated with the need for intensive care. Aside metagenomic analyses, The investigators will perform semi-quantitative cultures of the oropharyngeal and gut microbiota to identify and quantify pathogens in order to predict the risk of bacterial infections in COVD-19 patients.

For patients transferred in intensive care unit, The investigators will to perform another series of samples to better characterize the evolution of microbiota during mechanical ventilation and identify factors associated with the risk of developing a ventilator-associated pneumonia.

Microbiota data will be considered together with the host genotype, the viral sequence and a deep immunological profiling to identify the main determinants of the evolution toward severity of COVID-19.


title: Observational Study of Glycemic Control and Self-management of Young People (Aged 13 to 25 Years ) With Type 1 Diabetes During COVID-19 Lockdown.

acronym: COVIDIABADO

summary:
Lockdown resulting from the COVID-19 pandemic was an unpreceded model of the impact of lifestyle on chronic diseases, especially for adolescents and young adults with type 1 diabetes (T1D) whose lifestyle is known to strongly impact disease management. The investigators aimed to assess changes in self-monitoring and glycemic control in this population before, during, and after the two-month French lockdown. Te investigators hypothesized an improvement in glucose control and glucose sensor usage.

The protocol will include all patients with T1D from 13 to 25 years old using a flash glucose monitoring related to the LibreView cloud platform.

The primary outcome, evolution of percentage of glucose time in range 70-180 mg/dL (TIR), and secondary outcomes (glucose management indicator GMI, time spent below range TBR, and sensor usage) will be analyzed with a linear mixed-effects regression model.


title: Hospital Interns Psychological State During the COVID-19 Pandemic

acronym: RESICOV

summary:
The mental health of the French population in response to covid-19 pandemic is of concern.

Health professionals are prone to more mental disorders due to their direct exposure to the pandemic consequences. Indeed, compared to general population, health care workers face enormous in the current health situation, especially those who may be in contact with suspected or confirmed cases (risk of infection, inadequate protection, loss of control, lack of experience in managing the diseases, overwork, stigma, lack of support). Thus, it seems interesting to describe the psychological state of hospital interns during this pandemic.


title: Return to Work and Functional Results of French Soldiers After Anterior Cruciate Ligament Reconstruction

summary:
The return to work in the military population after surgical reconstruction of the anterior cruciate ligament (ACL) has been poorly investigated within the French armed forces. Only American studies are available and show that this surgery has a significant impact on the operational capacity of soldiers.

ACL rupture is extremely frequent in active populations. This pathology has already been extensively explored in at-risk populations, particularly in sports. Most studies show that the resumption of sport is greatly affected by this pathology.

Furthermore, an over-risk (10 times greater incidence of ACL rupture) in the military has been demonstrated.

lead_sponsor: Direction Centrale du Service de Santé des Armées


title: Impact of Respiratory Rehabilitation on Quality of Life, Measures by the SF-36 Score, in Patients With Hyperventilation Syndrome: Crossover, Prospective and Randomized Study

acronym: RESPIR-HVS

summary: The hyperventilation syndrome is a quite frequent pathology, affecting up to 10% of the general population and 40% of the asthmatic population. Its physiopathology is still badly known and even if it is a benign affection, its associated comorbidities and symptomatology greatly decrease the patients' quality of life. Yet, no medicinal treatments have been proved useful, but prescribers noticed improvements after physiotherapy. Given that the physiotherapy impact on hyperventilation syndrome is not well described in the literature, this study aims to scientifically ascertain physiotherapy benefits on quality of life and symptomatology in hyperventilation syndrome-suffering patients.

ReferenceCitation: Gardner WN. The pathophysiology of hyperventilation disorders. Chest. 1996 Feb;109(2):516-34. Review.

ReferenceCitation: Lewis RA, Howell JB. Definition of the hyperventilation syndrome. Bull Eur Physiopathol Respir. 1986 Mar-Apr;22(2):201-5.

ReferenceCitation: Thomas M, McKinley RK, Freeman E, Foy C. Prevalence of dysfunctional breathing in patients treated for asthma in primary care: cross sectional survey. BMJ. 2001 May 5;322(7294):1098-100.

ReferenceCitation: Lewis T, Cotton, Barcroft J, Dufton D, Milroy TR, Parsons TR. BREATHLESSNESS IN SOLDIERS SUFFERING FROM IRRITABLE HEART. Br Med J. 1916 Oct 14;2(2911):517-9.

ReferenceCitation: van Dixhoorn J, Duivenvoorden HJ. Efficacy of Nijmegen Questionnaire in recognition of the hyperventilation syndrome. J Psychosom Res. 1985;29(2):199-206.

ReferenceCitation: Vansteenkiste J, Rochette F, Demedts M. Diagnostic tests of hyperventilation syndrome. Eur Respir J. 1991 Apr;4(4):393-9.

ReferenceCitation: Nixon PG. Effort syndrome: hyperventilation and reduction of anaerobic threshold. Biofeedback Self Regul. 1994 Jun;19(2):155-69.

ReferenceCitation: Chenivesse C, Similowski T, Bautin N, Fournier C, Robin S, Wallaert B, Perez T. Severely impaired health-related quality of life in chronic hyperventilation patients: exploratory data. Respir Med. 2014 Mar;108(3):517-23. doi: 10.1016/j.rmed.2013.10.024. Epub 2013 Nov 7.

ReferenceCitation: Kraft AR, Hoogduin CA. The hyperventilation syndrome. A pilot study on the effectiveness of treatment. Br J Psychiatry. 1984 Nov;145:538-42.

ReferenceCitation: Van De Ven LL, Mouthaan BJ, Hoes MJ. Treatment of the hyperventilation syndrome with bisoprolol: a placebo-controlled clinical trial. J Psychosom Res. 1995 Nov;39(8):1007-13.

ReferenceCitation: Hoes MJ, Colla P, Folgering H. Clomipramine treatment of hyperventilation syndrome. Pharmakopsychiatr Neuropsychopharmakol. 1980 Jan;13(1):25-8.

ReferenceCitation: Jones M, Harvey A, Marston L, O'Connell NE. Breathing exercises for dysfunctional breathing/hyperventilation syndrome in adults. Cochrane Database Syst Rev. 2013 May 31;(5):CD009041. doi: 10.1002/14651858.CD009041.pub2. Review.


title: Use of Nomogram for Predictions of Ocular Mysathenia Gravis Generalization

acronym: MYASTEN

summary: Secondary ocular myasthenia gravis (OMG) generalization represents a pejorative evolution and no validated generalization prevention strategy exists. The aim of this observational study was to determine the percentage of patients with OMG generalization and identify factors predictive of that pejorative evolution. Data from patients with OMG registered in the Fondation Hospital A. de Rothschild database between January 1990 and January 2017 were collected. Among the 183 patients registered in this database, 151 patients with available informations were analyzed.

lead_sponsor: Fondation Ophtalmologique Adolphe de Rothschild


title: Evaluation de l'Observance thérapeutique à la spirométrie Incitative Chez Les Patients drépanocytaires

summary:
Sickle cell disease is one of the most common genetic diseases in the world. (1) It is characterized by the production of abnormal hemoglobin mainly responsible for vaso-occlusive clinical manifestations and chronic hemolysis with anemia. (2) It is therefore a chronic disease with major acute complications, such as acute chest syndrome. The treatment for this syndrome will be based on oxygenation, hydration and analgesia. At the physiotherapy level, we will have an action on the prevention and treatment of the syndrome by incentive spirometry. (3,4) In fact, it is currently the only physiotherapy treatment that has proven its effectiveness and is recommended for sickle cell patients. (3) As part of prevention, it is recommended to prescribe incentive spirometry during vaso-occlusive crisis. It has been shown to reduce the risk of atelectasis and significantly limit the risk of developing ACS. (5) In treatment, it makes it possible to regain normal chest amplification and therefore to allow ventilation of unventilated areas. (3.4) However, in order to increase therapeutic efficacy, patient compliance is essential.

Adherence to treatment is a major problem in chronic diseases. Currently, it is estimated that 80% of patients with chronic conditions do not sufficiently follow their therapy, which limits the optimization of benefits. (6) This is the case in sickle cell patients, especially with hydroxyurea which is their disease-modifying treatment. Lack of adherence is the most common cause of primary failure of this treatment.

During various treatments, we noticed the patients' lack of compliance with spirometry. Indeed, we explained to the patient how to do the incentive spirometry, so that he could practice it several times a day as recommended. When we returned the next day, or after a weekend, most of the time the patients had little or no observance. So I wanted to know if this concerns a majority of patients with sickle cell disease. Indeed, it appears important to assess compliance in these patients in order to improve the effectiveness of treatment and reduce the risk of ACS.

lead_sponsor: Centre Hospitalier Intercommunal Creteil

location_facility: Centre hospitalier intercommunal de Créteil


title: Evaluation of a Remotely Guided Physical Preparation by a Physical Activity Teacher Adapted With the Help of a Smartwatch Before Bronchial Cancer Surgery

acronym: PREPACHIR

summary: This is a study of a preoperative rehabilitation program with remotely guided high-intensity exercises by physical activity teachers adapted to a smartwatch in patients with operable lung cancer.


title: Monocentric Single-blind Randomized Controlled Trial Evaluating the Impact of the Addition of a Specific and Personalized Body Approach by Osteopathic Treatment in the Care of Adolescents With Anorexia Nervosa

acronym: ACAMTO

summary:
Abstract:

Background: Anorexia nervosa (AN) is a common pathology affecting mainly women (sex ratio 1/10), which starts most often during adolescence. The prognosis of the AN remains poor (10% of deaths and high risk of chronicity). Body dissatisfaction, disturbances in recognition and identification of body sensations are some of the key symptoms of AN. There is, however, a contrast between this consensual observation of the importance of troubles in body image in AN, and the relative deficit of specifically targeted body treatments. Our proposal for a body approach specifically dedicated to AN is based on the understanding that posture, breathing, muscle tension and body perception are closely linked to our psychological and emotional state, and are therefore disturbed in patients with AN.

The purpose of this monocentric randomized controlled trial is to evaluate if a targeted osteopathic protocol treatment for AN in addition to as-usual care is significantly more effective compared to as-usual care.

Methods: Seventy-two female patients meeting the inclusion criteria will be randomly assigned to one of the two treatment groups : one receiving the specific osteopathic treatment targeted for AN in addition to the as-usual care (group A) and the other one, the as-usual care (group B). The patients of group A will receive 5 sessions of osteopathic treatment for 25 minutes. Soft specific palpatory techniques on the diaphragm, digestive system and cervical region will be realized. The as-usual care is defined by the multidisciplinary approach recommended by the high authority of health. The primary outcome is the evaluation of interoceptive sensibility and secondary outcomes include clinical and psychopathology-related symptoms and assessment of somatic dysfonctions' evolution. A qualitative study will also be carried out, applying the Interpretative Phenomenological Analysis method. Patients will be included for a maximum of 14 weeks between the inclusion time and the last evaluation.

Discussion:

If the results of the study are positive (statistically significant effectiveness of this body approach in addition to as-usual care compared to as-usual treatment), patients with anorexia will be benefit from the possibility of additional treatment that is effective, relatively inexpensive, non-invasive and non-pharmacological.

ReferenceType: derived

ReferenceCitation: Letranchant A, Montebello YK, Bigre CD, Wagner A, Curt F, Silva J, Nicolas I, Votadoro P, Kalindjian N, Korchonnoff A, Gutierre A, Novelli AB, Pham-Scottez A, Corcos M. The ACAMTO study-impact of add-on osteopathic treatment on adolescent patients with anorexia nervosa: study protocol for a randomized controlled trial. Trials. 2021 Nov 24;22(1):839. doi: 10.1186/s13063-021-05810-8.

family: Letranchant

full_name: Aurélie Letranchant

given: Aurélie

family: Montebello

full_name: Yunkyung Kim-de Montebello

given: Yunkyung Kim-de

family: bigre

full_name: Corinne Dugré-Le bigre

given: Corinne Dugré-Le

family: Wagner

full_name: Agathe Wagner

given: Agathe

family: Curt

full_name: Florence Curt

given: Florence

family: Silva

full_name: Jérôme Silva

given: Jérôme

family: Nicolas

full_name: Isabelle Nicolas

given: Isabelle

family: Votadoro

full_name: Pablo Votadoro

given: Pablo

family: Kalindjian

full_name: Nina Kalindjian

given: Nina

family: Korchonnoff

full_name: Anna Korchonnoff

given: Anna

family: Gutierre

full_name: Andréa Gutierre

given: Andréa

family: Novelli

full_name: Ana Beatriz Novelli

given: Ana Beatriz

family: Pham-Scottez

full_name: Alexandra Pham-Scottez

given: Alexandra

family: Corcos

full_name: Maurice Corcos

given: Maurice

currency_apc_doaj: GBP

journal_name: Trials

oa_host_type: publisher

evidence: oa journal (via doaj)

host_type: publisher

license: cc-by

license_normalized: cc-by

version: publishedVersion

publisher: Springer Science and Business Media LLC

publisher_dissemination: Springer-Nature

publisher_group: Springer-Nature

publisher_normalized: Springer

title: The ACAMTO study—impact of add-on osteopathic treatment on adolescent patients with anorexia nervosa: study protocol for a randomized controlled trial

lead_sponsor: Institut Mutualiste Montsouris


title: Validation of COVILUS Score in Patients Suspected of COVID-19 Infection in the Emergency Room

summary: Covid-19 (English acronym meaning coronavirus disease 2019) is an emerging infectious disease caused by a strain of coronavirus called SARS-CoV-2. The current pandemic has resulted in a significant number of admissions in the emergency room (ER) due to suspicion of COVID-19 infection. Use of lung ultrasound is standard practice to diagnose acute respiratory failure in ER. Recently, typical lung ultrasonographic characteristics of COVID-19 disease has been described. The investigators demonstrated that the association of 4 signs in pulmonary ultrasound associated with a clinical sign (COVILUS score) could predict the occurrence of a positive RT-PCR in patients suspected of COVID-19 infection admitted to the emergency room. The investigators are going to conduct a new study to validate this COVILUS score in this type of patient. The main objective will be to validate the diagnostic performance of lung ultrasound in patients admitted to the emergency room with suspected COVID19 infection.


title: Prediction of the Patient Pathway in Emergency Room in an Exceptional Sanitary Situation

summary: The COVID-19 outbreak leads to optimize the pathway in emergency departments. The length of time spent in the Emergency Department is linked to the morbi-mortality and the risk of COVID-19 transmission. The Amiens-Picardy University Hospital has developed an application (3P-U) that optimizes patient flow. It identifies the need of hospitalization and problems on the care path. Patients are categorized in high risk or not high probabilty of hospitalization. The main goal of this project is to evaluate the impact on the patient flow of the 3P-U application. Early lookup of bed for high probability hospitalization should be linked to a reduced time of length. This study will compare the time of length between this both groups.


title: Observatoire National Des méningites bactériennes de l'Enfant et du Nouveau-né

summary: Bacterial meningitis is a major cause of morbidity and mortality in childhood. Antibiotic treatment recommendations are based on epidemiological and susceptibility data. The epidemiology of bacterialméningitis has changed in recent years, mainly owing to widespread use of different conjugate vaccines. The aim of this prospective national survey is to describe epidemiology of bacteria implicated in bacterial meningitis in children.

lead_sponsor: Association Clinique Thérapeutique Infantile du val de Marne


title: Randomized, Double-blind, Placebo-controlled Clinical Trial of Nicotinamide Mononucleotide on Muscle Recovery and Physical Capacity in Healthy Volunteers With Moderate Physical Activity

summary: The purpose of this study is to evaluate the effect of NMN supplementation (250 and 500 mg/day over 38 days) compared to placebo in healthy volunteers with moderate physical activity on muscle recovery, physical capacity, cardiorespiratory recovery, the perception of the arduousness of the effort, the variation in blood lactate levels before and after physical exercise, the perception of the intensity of post-exercise muscle pain (cramps), the body composition and Nicotinamide-Adenine Mononucleotide (NAD+) level in blood.

lead_sponsor: Seneque SA


title: Epidemiology of CoV-2 SARS Infections: Dynamics of Community Contamination in Children and Adults

summary: Unlike other respiratory viruses such as influenza and Respiratory Syncytial Virus (RSV) where the child is the essential reservoir and central vector of intrafamilial contamination, the child is likely to be a small player in the transmission of Severe Acute Respiratory Syndrome CoronaVirus 2 (SRAS-CoV2) infection. This study aims to describe the age category of the first contact, within 14 days before the appearance of the first symptoms of the index case in order to describe the age categories of this first contaminant, globally, in the group of children and finally in the group of adults. This work is intended to provide food for discussion and to justify the distancing and containment measures imposed on children when their isolation has a deleterious impact that has now been established for some children.

lead_sponsor: Hospices Civils de Lyon


title: Description of Immunologic, Enzymatic and Metabolic Biomarkers Associated to the Severity of COVID-19 and Its Resolution

acronym: BIOMARK-COVID

summary: Prospective study to describe the immunological, metabolic and serologic profile in the acute and post acute phases of Coronavirus disease (COVID-19)

lead_sponsor: Poitiers University Hospital


title: Validation Study of the ALYATEC Allergen Exposure Chamber by Determining the Concentration of House Dust Mite Allergen Inducing Early and/or Late Bronchial Response in Asthmatic Subjects Allergic to Mite

summary:
This is a randomized, double blind, cross-over study designed to determine the concentration of airborne house dust mite allergen inducing bronchial response in asthmatic subjects allergic to mite, during allergen exposures in the Alyatec environmental exposure chamber (EEC).

The study was also designed to validate the specificity of the asthmatic reaction induced by exposure to airborne house dust mite allergen in Alyatec EEC.

ReferenceCitation: Khayath N, Doyen V, Gherasim A, Radu C, Choual I, Beck N, Jacob A, Schoettel F, Vecellio L, Domis N, de Blay F. Validation of Strasbourg environmental exposure chamber (EEC) ALYATEC(®) in mite allergic subjects with asthma. J Asthma. 2020 Feb;57(2):140-148. doi: 10.1080/02770903.2018.1563902. Epub 2019 Mar 28.

name: Chest Diseases Department, Strasbourg University Hospital, Strasbourg, France;

name: Federation of Translational Medicine EA 3070, University of Strasbourg, Strasbourg, France;

family: Khayath

full_name: Naji Khayath

given: Naji

name: Clinics of Immuno-Allergology, CHU Brugmann, Université Libre de Bruxelles (ULB), Brussels, Belgium;

family: Doyen

full_name: Virginie Doyen

given: Virginie

name: Biocluster des Haras, ALYATEC®, Strasbourg, France;

family: Gherasim

full_name: Alina Gherasim

given: Alina

family: Radu

full_name: Carmen Radu

given: Carmen

family: Choual

full_name: Ibrahim Choual

given: Ibrahim

family: Beck

full_name: Nicole Beck

given: Nicole

family: Jacob

full_name: Audrey Jacob

given: Audrey

family: Schoettel

full_name: Florian Schoettel

given: Florian

name: François-Rabelais University, Tours Cedex, France

family: Vecellio

full_name: Laurent Vecellio

given: Laurent

family: Domis

full_name: Nathalie Domis

given: Nathalie

family: de Blay

full_name: Frédéric de Blay

given: Frédéric

journal_name: Journal of Asthma

publisher: Informa UK Limited

publisher_dissemination: Informa

publisher_group: Informa

publisher_normalized: Informa

title: Validation of Strasbourg environmental exposure chamber (EEC) ALYATEC® in mite allergic subjects with asthma