title: Blockade of the Renin-angiotensin-aldosterone System in Patients With ARVD: a Double-blind Multicentre Prospective Randomized Study.

acronym: BRAVE

summary:
Arrhythmogenic right ventricular dysplasia (ARVD) is a rare cardiomyopathy characterized by the progressive replacement of cardiomyocytes by fatty and fibrous tissue in the right ventricle (RV). These infiltrations lead to cardiac electrical instability and ventricular arrhythmia.

Current treatment for ARVD is empirical and essentially based on treatment of arrhythmia. Thus, there is no validated treatment that will prevent the deterioration of the RV function in patients with ARVD.

The investigator's hypothesis is that the use of anti-fibrotic medications will prevent or at least reduce the deterioration of the RV function. The aim of this project is to evaluate the effect of spironolactone, a Potassium-sparing diuretic on ventricular myocardial remodeling and on arrhythmia burden in patients with ARVD.

The trial is a double-blind parallel multicenter prospective randomized phase II drug study. Patients will be randomized in the two groups: spironolactone or placebo. 19 centers in France will enroll the 120 patients (60 per group). Patients will be followed up every 6 months for 3 years. A decrease in right and/or left ventricular deterioration and in arrhythmia burden are expected in ARVD patients treated with spironolactone. This reduction will improve the quality of life of patients and will reduce the number of hospitalizations and the risk of terminal heart failure.


type: Other Identifier

title: Impact of Sport Practice and Hyperlipidic Meal on Free Circulating DNA in Patients With Metastatic Colonic Cancer and Healthy Subjects. Physiological Pilot Study

acronym: ASRHACOLS

summary: The study of circulating tumoral DNA makes it possible to study, without invasive procedures or pathological studies, the tumoral DNA circulating in the blood of a patient and its various alterations. In patients with colon-rectal cancer with resected tumor, circulating tumor DNA can be used as a predictive biomarker of metastatic relapse of cancer. However, the routine extension of circulating tumoral DNA remains limited due to several difficulties. One of the pifalls that circulating tumor DNA is greatly diluted by healthy circulating DNA from non-tumor cells. The amount of healthy circulating DNA has been described as being influenced by certain physiological parameters. The aim of the study is to increase knowledge on the influence of physiological factors associated with sports activity and meal on the release kinetics of circulating DNA.

study_start_date_type: Anticipated

status: Not yet recruiting

study_completion_date_type: Anticipated

study_type: Interventional

design_allocation: Non-Randomized

primary_purpose: Basic Science

enrollment_type: Anticipated

ipd_sharing: Yes

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

lead_sponsor: Assistance Publique - Hôpitaux de Paris

location_facility: Assistance Publique Hôpitaux de Paris, Hôpital européen Georges Pompidou

intervention_type: Other

lead_sponsor_type: academique

status_simplified: Ongoing


title: Evaluation of the Radiological Dose Delivered to Risky Interventional Cardiology Patients (Optidose)

acronym: Optidose

summary: The purpose of this study is therefore to study the actual doses of X-rays delivered to the patient's skin during recanalization of a coronary artery in a context of Chronic Total Occlusion

study_start_date_type: Actual

status: Recruiting

study_type: Observational

time_perspective: Prospective

lead_sponsor: Ramsay Générale de Santé

intervention_type: Radiation

lead_sponsor_type: industriel


title: Rapid Quantitative Neutrophil CD64 Measurement for Early Diagnosis of Nosocomial Infection in Preterm Newborns

summary:
Diagnosis of late-onset sepsis is difficult in the absence of specific clinical signs and biological markers in the infection initial phase .The aim of this study is to determine the performance of a new infection marker : Neutrophil CD64 for early diagnosis in nosocomial infection (NI) in preterm newborns.

METHODS :

Monocentric prospective study including preterm newborn infants (<37 weeks of gestationnal age ) with clinical suspicion of nosocomial infection in a neonatal intensice care unit (Neonatal intensive care unit of Montpellier, France).
Patients will be enrolled in the study after informed consents. Rapid and automated CD64 measurment will be realized during the conventional blood sample including C-Reactive Protein (CRP), Procalcitonin (PCT) and blood culture.

Broad-spectrum antibiotic therapy can be started on the advice of clinician and blinded the result of CD64. Patients will be then classed in three groups using CDC criteria (center for disease control) : 1-no infection, 2-infection, 3-possible infection during the multidisciplinary staff. Specificity, sensitivity, negative and positive value of CD64 will be calculated and the performances of CRP, PCT and CD64 will be compared.

153 patients are needed in the study enrolled during a period of 12 months.

PERSPECTIVES Neutrophil CD64 monitoring might be help clinicians to manage nosocomial infections in neonates.CD64 allow to integrate in a decision algorithm with the determination of the best cut-off value to faster processing nosocomial infections and could help to reduce unnecessary antibioc therapy. A rapid technique for determination of CD64 should be readily available in our unit.

status: Unknown status

primary_purpose: Diagnostic

lead_sponsor: University Hospital, Montpellier

status_simplified: Unknown


title: Study of the Impact of a Social Telepresence Robot on Social Isolation and Loneliness of the Elderly at Home

acronym: DOMIROB

summary: The main purpose of this monocentric, prospective study is to measure the impact of the implementation of a robotic social telepresence tool, during three months at home, on the feeling of loneliness and social isolation of the elderly

ReferenceType: derived

ReferenceCitation: Isabet B, Rigaud AS, Li W, Pino M. Telepresence Robot Intervention to Reduce Loneliness and Social Isolation in Older Adults Living at Home (Project DOMIROB): Protocol for a Clinical Nonrandomized Study. JMIR Res Protoc. 2022 Oct 31;11(10):e40528. doi: 10.2196/40528.

lead_sponsor: Gérond'if

intervention_type: Device


title: Impact of Omalizumab Withdrawal After a 3 Year Duration Treatment in Well Controlled Severe Allergic Asthma : a Multicentric Randomized Controlled Trial

acronym: SHORTEN

summary:
The optimal duration of the treatment by OMA remains unclear when asthma is well controlled. Data suggest that a large part of patients with well controlled asthma can discontinue OMA therapy without any asthma control deterioration or with an acceptable decrease in asthma control, therefore French experts propose that omalizumab can be given for "3 to 5 yrs if asthma remains well controlled".

The costs related to OMA are high and frequent injections represent severe constraints for patients. For all these reasons, evaluating whether shortening duration of OMA therapy is feasible while maintaining acceptable asthma control is a critical point. Therefore, the aim of this study is to evaluate asthma control after OMA discontinuation after 3 to 5 years of treatment when asthma is well controlled.

design_allocation: Randomized

primary_purpose: Treatment

ipd_sharing_description:
Data are available upon reasonable request. The procedures carried out with the French data privacy authority (CNIL, Commission nationale de l'informatique et des libertés) do not provide for the transmission of the database, nor do the information and consent documents signed by the patients.

Consultation by the editorial board or interested researchers of individual participant data that underlie the results reported in the article after deidentification may nevertheless be considered, subject to prior determination of the terms and conditions of such consultation and in respect for compliance with the applicable regulations.


title: Survival and Quality of Life After Liver Transplantation in Patients Aged 65 and Over

summary: The main objective of this non-interventional, single-center study is to assess survival and associated factors at 1 year in patients aged 65 and over who received liver transplantation

location_facility: Geriatric Department, Paul Brousse Hospital


title: Assessment of the Impact of COVID-19 on Transplant Patients and on Patients Awaiting Transplantation

acronym: COWAIT

summary: To provide optimal care to patients and to maintain long-term institutional viability, Transplant Centres (TC) must have an awareness of their patients' health status, their health care needs and priorities, as well as their access to information and health care. For example, it is critical that TCs understand whether their patients are medically suitable for transplant, whether transplantation remains a priority for their patients, how best to communicate with their patients, and whether their patients have sufficient access to medications and health care to undergo transplant safely. The COVID-19 pandemic has had a tremendous impact on people and institutions around the country in a short period of time. At this time, little is known regarding its impact on the transplant community specifically. For example, it has been reported that around 8 million French applied for partial unemployment benefit over the past month, but it is not known if this has affected transplant patients. It has been reported that people with significant chronic medical conditions and those with compromised immune systems may be at increased risk of dying from the COVID-19, but it is not known if this has affected patients' interest in receiving transplants at this time. The "Société Francophone de Transplantation (SFT)" published recommendations at the beginning of the pandemic in order to limit the rate of infection in these high-risk population. The purpose of this study is to better understand the impact of COVID-19 on patients on the waiting list and transplant patients. Further, a better understand on how patients have received information about this pandemic and how best to communicate with them.

status: Completed

study_completion_date_type: Actual

enrollment_type: Actual

lead_sponsor: University Hospital, Bordeaux

status_simplified: Completed


title: DREPAMASSE Study - Evaluation of a Newborn Screening for Sickle Cell Disease by Tandem Mass Spectrometry

acronym: DREPAMASSE

summary:
Three methods are actually used in newborn screening for sickle cell disease (SCD) in France: isoelectric focusing, high performance liquid chromatography and capillary electrophoresis. New technologies are currently under development such as Matrix Assisted Laser Desorption Ionisation - Time of Flight (MALDI-TOF) and tandem mass spectrometry (MS/MS) using the SpOtOn Diagnostics Reagent Kit available in United Kingdom only.

Zentech company (Liège, Belgium) is developing a package for SCD newborn screening using MS/MS technology. The main objective of the present study will be to compare this new technique with the technique actually used in the hospital center of Lille (sub-contractor for SCD newborn screening of Lyon) and the haemoglobin analysis to test its accuracy (sensitivity and specificity).

time_perspective: Retrospective

lead_sponsor: Hospices Civils de Lyon

location_facility: Groupement Hospitalier Est - Hospices Civils de Lyon


title: Study of the Immunological and Virological Response of Patients Infected With SARS-CoV-2 and Presenting an Asymptomatic or Pauci-symptomatic Form

acronym: AMBUCOV

summary:
The purpose of this study is to describe the immunological and virological response of patients infected with CoV-2-SARS and presenting an asymptomatic or mildly symptomatic form, in particular the innate and adaptive response as well as the virological clearance kinetics.

The research hypothesis is that patients with an ambulatory form of SARS-CoV-2 infection, whether asymptomatic or mildly symptomatic, are able to mount an innate and adaptive immunological response capable of rapidly clearing the virus, in contrast to severe forms in which an early deficit of type 1 IFN response has been demonstrated, possibly responsible for a defect in the control of viral replication in the blood.

ReferenceType: background

ReferenceCitation: Zhu N, Zhang D, Wang W, Li X, Yang B, Song J, Zhao X, Huang B, Shi W, Lu R, Niu P, Zhan F, Ma X, Wang D, Xu W, Wu G, Gao GF, Tan W; China Novel Coronavirus Investigating and Research Team. A Novel Coronavirus from Patients with Pneumonia in China, 2019. N Engl J Med. 2020 Feb 20;382(8):727-733. doi: 10.1056/NEJMoa2001017. Epub 2020 Jan 24.

ReferenceCitation: Yang X, Yu Y, Xu J, Shu H, Xia J, Liu H, Wu Y, Zhang L, Yu Z, Fang M, Yu T, Wang Y, Pan S, Zou X, Yuan S, Shang Y. Clinical course and outcomes of critically ill patients with SARS-CoV-2 pneumonia in Wuhan, China: a single-centered, retrospective, observational study. Lancet Respir Med. 2020 May;8(5):475-481. doi: 10.1016/S2213-2600(20)30079-5. Epub 2020 Feb 24. Erratum in: Lancet Respir Med. 2020 Apr;8(4):e26.

ReferenceCitation: Hadjadj J, Yatim N, Barnabei L, Corneau A, Boussier J, Smith N, Péré H, Charbit B, Bondet V, Chenevier-Gobeaux C, Breillat P, Carlier N, Gauzit R, Morbieu C, Pène F, Marin N, Roche N, Szwebel TA, Merkling SH, Treluyer JM, Veyer D, Mouthon L, Blanc C, Tharaux PL, Rozenberg F, Fischer A, Duffy D, Rieux-Laucat F, Kernéis S, Terrier B. Impaired type I interferon activity and inflammatory responses in severe COVID-19 patients. Science. 2020 Aug 7;369(6504):718-724. doi: 10.1126/science.abc6027. Epub 2020 Jul 13.

ReferenceCitation: Lucas C, Wong P, Klein J, Castro TBR, Silva J, Sundaram M, Ellingson MK, Mao T, Oh JE, Israelow B, Takahashi T, Tokuyama M, Lu P, Venkataraman A, Park A, Mohanty S, Wang H, Wyllie AL, Vogels CBF, Earnest R, Lapidus S, Ott IM, Moore AJ, Muenker MC, Fournier JB, Campbell M, Odio CD, Casanovas-Massana A; Yale IMPACT Team, Herbst R, Shaw AC, Medzhitov R, Schulz WL, Grubaugh ND, Dela Cruz C, Farhadian S, Ko AI, Omer SB, Iwasaki A. Longitudinal analyses reveal immunological misfiring in severe COVID-19. Nature. 2020 Aug;584(7821):463-469. doi: 10.1038/s41586-020-2588-y. Epub 2020 Jul 27.

ipd_sharing: No


title: Contraception and Cervical and Breast Cancer Screening in Obese Versus Non-obese Women Aged 25 to 74 Years Old

acronym: DEPISGYN

summary:
.Brief Summary:* Obesity is a major public health problem in France. Indeed, 17% of the French population is obese (BMI greater than or equal to 30 kg/m²) while almost half of the adult population is overweight (BMI greater than or equal to 25 kg/m²).

There is an increased risk of gynecological cancer in obese women but screening is less often performed :

In women, obesity is a risk factor for the occurrence of certain cancers such as uterine cancer, epithelial ovarian cancer and breast cancer, particularly post-menopausal. In addition, an increase in BMI from the first stage of obesity is associated with larger breast tumors with more frequent lymph node involvement, indicating more invasive cancers. Recent studies have shown an increase in breast cancer mortality for women with grade 2 and 3 obesity compared to women of so-called normal weight. Mortality from invasive breast cancer is higher from the obesity stage onwards.

The current recommendations of the High Authority for Health recommend breast cancer screening by mammography and clinical examination every two years in all women aged 50 to 74, excluding women at high risk and requiring specialist follow-up. Organized screening for cervical cancer has recently been modified. From 25 to 30 years of age the modalities remain the same and consist of two cytological examinations one year apart and then every 3 years if the latest results are normal. From the age of 30 and up to the age of 65, it is now recommended that an HPV test be performed as a first-line test, 3 years after the last normal cytological examination and then every 5 years if the last test was negative.

Studies dating back quite some time had shown an under-screening of cancers in obese women, in terms of carrying out mammography and cervical smears compared to women of normal weight. More recent data on access to gynecological cancer screening for obese women are heterogeneous, but there still seems to be less access to these examinations, whether for mammography or cervical smears. For example, a large American cohort study observed poorer detection of pre-cancerous lesions by smear with increasing BMI. Obese women had the lowest cumulative risk of pre-cancerous lesions at five years (followed by overweight women), but the highest rate of cancer at five years, associated with higher mortality.

A neglected contraception in obese women?

Data in the literature show that rates of unintended and unplanned pregnancies are higher in obese women (mainly those with grade 3 obesity) than in normal-weight women. This is associated with a lower use of contraception which is certainly poly-factorial: contraception not necessary due to a decrease in fertility linked to obesity, increased risks linked to contraception in obese women... However, most current contraceptive methods have shown similar efficacy in obese and non-obese women.

This context suggests that there is still a marked difference in the gynecological management of obese women. The role of the general practitioner seems essential in this follow-up by facilitating the use of screening tests and by improving the information of this population with regard to contraception in particular.

The objective of this study is to compare the gynecological follow-up of obese and non-obese women in a sample of women in Occitania, in terms of screening for breast and cervical cancer, as well as in terms of access to a method of contraception in general practice.

ipd_sharing: Undecided

ipd_sharing_description: NC


type: EudraCT Number

title: RIVA-PSP: Efficacy of Rivastigmine on Motor, Cognitive and Behavioural Impairment in Progressive Supranuclear Palsy: A Randomised Double Blind Placebo-controlled Clinical Trial

acronym: RIVA-PSP

summary:
Progressive supranuclear palsy (PSP) is a rare neurodegenerative disease from the parkinsonian syndrome group. It represents 5 to 10% of all parkinsonian syndromes and affects 3,000 to 10,000 persons in France. PSP is characterised by a doparesistant parkinsonism with axial signs such as early gait instability and falls, oculomotor signs such as a vertical gaze palsy, dysphagia and dysarthria, and both cognitive and behavioural disturbances. The latter predominantly manifest as psycho-motor slowness, apathy and frontal executive deficits. Swallowing impairments and falls may lead to life-threatening situations and death occurs 6-9 years after disease onset.

Apart from L-dopa which may transiently and inconsistently improve motor symptoms no effective symptomatic, disease-modifying or neuroprotective therapy is presently available to reduce disability in any way. Therefore these patients often receive mostly non-medical care such as physiotherapy and speech therapy.

In addition to dopaminergic degeneration there is evidence of cholinergic deficits in PSP correlated with gait and balance impairments . This stands in contrast with the limited number of studies of cholinergic augmentation strategies in PSP.

Trials of cholinesterase inhibitors in PSP have produced rather conflicting results: donepezil improves cognition but deteriorates some motor functions whereas a case series of 5 PSP patients treated with rivastigmine found an improvement in several cognitive aspects and no deterioration of motor functions .On the other hand in Parkinson's disease there is convincing evidence of a positive effect of rivastigmine on cognition , apathy and falls Investigators' hypothesis is that rivastigmine (an acetyl- and butyryl-cholinesterase inhibitor) may reduce gait and postural impairment in PSP and may therefore limit the number of falls and their consequences both in terms of injuries sustained (fractures etc...) and on the patients' autonomy. In addition investigators hypothesise that rivastigmine may also reduce the cognitive and behavioural impairment associated with PSP. Taken together these improvements are likely to produce a significant effect on the patients' quality of life and their caregiver burden.

status: Active, not recruiting

lead_sponsor: Assistance Publique Hopitaux De Marseille

location_facility: Service de Neurologie et Pathologie du Mouvement Hôpital de La Timone

intervention_type: Drug


title: Pelvic-perineal Disorders in Women With Sphincter Tears, a Retrospective Study

acronym: PAPOASI

summary:
According to INSEE, in 2016, in France, there were 785,000 births. According to the latest national perinatal survey in 2016, 80.4% of women gave birth by vaginal delivery. Of these, 52.1% had perineal tears and 0.8% had 3rd and 4th degree tears. Of these 3rd and 4th degree tears, 2.2% occurred during instrumental delivery and 0.5% during spontaneous delivery. In recent years, there has been an increase in the prevalence of obstetric anal sphincter injuries. Mc Pherson et al. found a prevalence of LOSA (Obstetric Anal Sphincter Injury) of 2% in 2004 versus 4.6% in 2008. Gurol-Urganci et al. also found an increase in prevalence from 1.8% in 2000 to 5.9% in 2012. This increase is probably due to improved diagnosis by obstetrical teams. Indeed, a large number of LOSAs remained undiagnosed at birth and these occult lesions were subsequently found by endoanal ultrasound. In the Andrews et al. study, when women were reexamined, the prevalence of LOSA increased from 11% to 24.5%. As practitioner training improved, the prevalence of LOSA at birth became increasingly accurate. Obstetric anal sphincter injuries are responsible for significant physical and psychological morbidity. These obstetrical lesions of the anal sphincter can generate functional consequences (including anal incontinence in the first rank), which will have harmful effects on the quality of life of the women, they can involve a social isolation passing by the limitation of displacements and physical and social activities. The daily life of these women can remain impacted by the consequences of LOSA until more than 10 years after delivery. In addition, a loss of self-esteem as well as feelings of guilt, shame and frustration are reported in these women. Thus, some will speak of a LOSA syndrome, which includes emotional, social and psychological consequences, including the ability to assume one's role as a mother. LOSA are perineal tears corresponding to the 3rd and 4th degree, formerly and respectively called complete perineum and complicated complete perineum. The Sultan classification for perineal tears proposed in 1999 was adopted by the Royal College of Obstretricians and Gynecologists (RCOG) and is the most widely used in the scientific literature worldwide. It defines the 3rd degree as a perineal injury involving the anal sphincter complex alone.

Anal continence is a balance between several factors such as rectal sensitivity, stool quality, the smooth and striated muscles of the anal sphincter, the pubo-rectal muscle webbing and the innervation of these structures. Obstetrical trauma of the stretching and compression type affects all these structures. All of these lesions can contribute to the development of anal incontinence. However, these structures are not routinely evaluated in women who have had an obstetric anal sphincter injury.

Pelvic-perineal pain was studied in 2 studies and involved 24.7% to 35% of women with obstetric anal sphincter injuries.

Compared to women without LOSA, women with LOSA had a later return to sexual intercourse, with more severe anal incontinence during the first week after LOSA. Indeed, at 12 weeks postpartum, the rate of women who resumed sexual intercourse was lower in the group of women with LOSA than in the group without LOSA.

The pelvic-perineal disorders faced by women with LOSA affect their quality of life, their sexuality, and their health. Thus, early identification of all pelvic-perineal disorders appears to be a priority in this population.

ReferenceCitation: McPherson KC, Beggs AD, Sultan AH, Thakar R. Can the risk of obstetric anal sphincter injuries (OASIs) be predicted using a risk-scoring system? BMC Res Notes. 2014 Jul 24;7:471. doi: 10.1186/1756-0500-7-471.

ReferenceCitation: Gurol-Urganci I, Cromwell DA, Edozien LC, Mahmood TA, Adams EJ, Richmond DH, Templeton A, van der Meulen JH. Third- and fourth-degree perineal tears among primiparous women in England between 2000 and 2012: time trends and risk factors. BJOG. 2013 Nov;120(12):1516-25. doi: 10.1111/1471-0528.12363. Epub 2013 Jul 3.

ReferenceCitation: Andrews V, Sultan AH, Thakar R, Jones PW. Occult anal sphincter injuries--myth or reality? BJOG. 2006 Feb;113(2):195-200.

ReferenceCitation: Cornell K, De Souza A, Tacey M, Long DM, Veerasingham M. The effect of implementing a new guideline and operative pro forma on the detection and management of third- and fourth-degree perineal tears. Int J Womens Health. 2016 May 5;8:131-5. doi: 10.2147/IJWH.S101188. eCollection 2016.

lead_sponsor: Groupe Hospitalier Paris Saint Joseph


title: Prognostic Value of Circulating Endothelial Progenitor Cells in Aneurysmal Subarachnoid Hemorrhage (Evaluation de l'intérêt Pronostic Des progéniteurs endothéliaux Circulants Dans l'hémorragie Sous-arachnoïdienne Par Rupture d'anévrysme cérébral)

acronym: EVAPROPEC

summary:
Aneurysmal subarachnoid hemorrhage is a common and serious disease associated to a high rate of mortality and morbidity. Severe definitive neurological impairment can concern up to 30% of patients in relation with elevated intracranial pressure, hemorrhage recurrence and symptomatic cerebral arterial vasospasm. This latter complication is defined as a reversible reduction of cerebral artery's diameter occurring between the 4th and the 14th day after bleeding. Physiopathology is not well understood, but could involve endothelium, trough endothelial progenitor cells (EPC). Circulating EPC are bone marrow-derived cells with capacity of vasculogenesis and angiogenesis. EPC have been recognized playing a beneficial role in cardiovascular disease and ischemic stroke. EPC have never been studied in aneurysmal subarachnoid hemorrhage.

The primary objective of this study is to compare the number of circulating endothelial progenitor cells between patients with a good neurological outcome (defined as a glasgow outcome scale = 1 or 2) and patients with a poor neurological outcome (glasgow outcome scale = 3, 4 or 5).

Briefly, the number of circulating EPC will be measured at admission, and at day 3, 6, 10, 14, 21 in each consecutive patient suffering aneurysmal subarachnoid hemorrhage and hospitalized in Teaching Hospital of Besançon (France). The neurological outcome will be measured one year after subarachnoid hemorrhage.

lead_sponsor: Centre Hospitalier Universitaire de Besancon


title: Evaluation of MRI Sequences for Ultra-rapid Acquisition of Bile Ducts Images

acronym: BiliFast

summary:
The Institute of Imaged-Guided Surgery (IHU Strasbourg) has two clinical Magnetic Resonance Imaging (MRI) scanners, one with a 3T (3 Teslas) magnetic field used for diagnosis, the other with a magnetic field of 1,5T (1,5 Teslas) used for the interventional (Pre / per / postoperative).

The reference for the visualization of the biliary and pancreatic ducts is a relatively long sequence that needs a breathing-synchronized acquisition leading to artefacts on the images (blur effect).

In order to reduce and/or standardize the acquisition time as well as to limit artefacts, accelerated sequences are developed. Such sequence is available in France recently in the form of WIP Siemens (Work In Progress: sequence in test phase at manufacturer to be marketed in the short or medium term on clinical machines). It incorporates a Compressed Sensing (CS) acquisition scheme allowing the acquisition of a 3D (3 dimensions) sequence similar to the usual sequence by drastically reducing the acquisition time, the sequence CS-SPACE. This sequence exists in two forms:

An ultra-rapid sequence acquired in apnea
An accelerated sequence but remaining synchronized with the breath. The study carried out here on a large number of patients, with two different magnetic fields, applied routinely for diagnosis or anticipation of surgery, could be used by the community of radiologists, hepatogastroenterologists and also digestive surgeons Hepatobiliary.

status: Terminated

ReferenceCitation: Bates DD, LeBedis CA, Soto JA, Gupta A. Use of Magnetic Resonance in Pancreaticobiliary Emergencies. Magn Reson Imaging Clin N Am. 2016 May;24(2):433-48. doi: 10.1016/j.mric.2015.11.010. Epub 2016 Feb 22. Review.

ReferenceCitation: Yoon JH, Lee SM, Kang HJ, Weiland E, Raithel E, Son Y, Kiefer B, Lee JM. Clinical Feasibility of 3-Dimensional Magnetic Resonance Cholangiopancreatography Using Compressed Sensing: Comparison of Image Quality and Diagnostic Performance. Invest Radiol. 2017 Oct;52(10):612-619. doi: 10.1097/RLI.0000000000000380.

ReferenceCitation: Chandarana H, Doshi AM, Shanbhogue A, Babb JS, Bruno MT, Zhao T, Raithel E, Zenge MO, Li G, Otazo R. Three-dimensional MR Cholangiopancreatography in a Breath Hold with Sparsity-based Reconstruction of Highly Undersampled Data. Radiology. 2016 Aug;280(2):585-94. doi: 10.1148/radiol.2016151935. Epub 2016 Mar 16.

lead_sponsor: IHU Strasbourg

location_facility: Service de Radiologie et d'Echographie, NHC Strasbourg


type: Registry Identifier

title: Use of Multispectral Imaging in Digestive Inflammation Diagnosis

acronym: ENDOSPECTRALE

summary:
The study aims as principal objective to show the association between reflectance intensity of mucosa at different wave lengths and

the presence of acute or chronic inflammation in stomach or rectum and normal mucosa;
the presence of glandular atrophy in stomach or intestinal metaplasia.

The secondary objectives are:

to identify reflectance profile which characterize an acute or a chronic inflammation, a glandular atrophy or an intestinal metaplasia, respectively;
to find a correlation between the reflectance to different frequencies and intensity of inflammation according to Sydney Classification in stomach (Dixon M F 1994) and in rectum (Erben U 2014).

location_facility: Service Hépato-Gastroentérologie, Hôpital Ambroise Paré


title: Impact of Bariatric Surgery in Obese Patients With and Without Obstructive Sleep Apnea Syndrome - COLOSS

acronym: COLOSS

summary: It has been shown to date that obesity is associated with increased mortality and that weight loss significantly improves cardiovascular risk factors. Among patients receiving bariatric surgery, 30-90% have moderate to severe obstructive sleep apnea (OSA) syndrome. Given the strong associations between OSA and cardiometabolic comorbidities, this project is based on the hypothesis of a lower improvement of cardiovascular risk factors and a higher number of post-surgical complications in OSAS patients.

intervention_type: Procedure


title: Epidemiological, Clinical and Etiological Features of SUSAC's Syndrome (RETINOCOCHLEOCEREBRAL Vasculopathy)

acronym: CARESS

summary:
SUSAC's Syndrome (SS) is characterized by the clinical triad of encephalopathy, hearing loss, and retinal artery branch occlusions. Since the first description of SS in 1979, hundreds of patients with SS, mostly young women, have been reported. However, comprehensive epidemiological, clinical and etiological features of SS have never been specifically addressed so far.

The objective of this study is to characterize the epidemiological, clinical, and etiological features of SUSAC's Syndrome. In this aim, the investigators will constitute a national clinical-based cohort including all SS cases retrospectively reported in France since the last 20 years and all new cases prospectively observed. French Society of Neurology, Ophthalmology and Internal Medicine will be asked to collaborate. Every case will be reviewed by an expert comity of internists, neurologists and neuroradiologists to validate the diagnosis. The exhaustive and systematic analysis of each case will help to better define different aspects of the disease such as the incidence and prevalence, the clinical presentation, the diagnostic modalities and the impact of treatments. Diffusion tensor magnetic resonance imaging of the brain will be obtained to more carefully study the cerebral microvasculopathy of the disease. Serum, cerebrospinal fluid, and DNA samples from each patient will also be collected to study potential autoimmune, thrombotic and infectious markers.

time_perspective: Other

ReferenceCitation: Scheifer C, Henry Feugeas MC, Roriz M, Cohen Aubart F, Doan S, Jouvent E, Klein I, Machado C, Rouzaud D, Papo T, Sacré K; French Susac Study Group. Brain magnetic resonance imaging lesion load at diagnosis, severity at onset and outcomes in Susac syndrome: A prospective cohort study. Eur J Neurol. 2022 Jan;29(1):121-129. doi: 10.1111/ene.15062. Epub 2021 Aug 23.

ReferenceCitation: David C, Papo T, Ba I, Ollivier E, Boileau C, Dieudé P, Keren B, Kannengiesser C, Sacre K. Hunting for the genetic basis of Susac syndrome. Eur J Neurol. 2021 Jul;28(7):e57-e59. doi: 10.1111/ene.14836. Epub 2021 Apr 7.

ReferenceCitation: Machado S, Jouvent E, Klein I, De Guio F, Machado C, Cohen-Aubart F, Sacré K, Papo T. Cognitive dysfunction and brain atrophy in Susac syndrome. J Neurol. 2020 Apr;267(4):994-1003. doi: 10.1007/s00415-019-09664-8. Epub 2019 Dec 11.


title: A Phase III, Multinational, Multicenter, Investigator-Masked, Randomised, Active-Controlled Trial, Comparing the Efficacy and Safety of DE-130A With Xalatan® in Patients With Open-Angle Glaucoma or Ocular Hypertension

summary: A Phase III, Multinational, Multicenter, Investigator-Masked, Randomised, Active-Controlled Trial, comparing the efficacy and safety of DE-130A with Xalatan® in Patients with Open-Angle Glaucoma or Ocular Hypertension over a 3-Month period, followed by a 12-Month Follow-Up with Open-Label DE-130A Treatment

lead_sponsor: Santen SAS


title: Home-based Cycling Using Connected Ergometric Bicycles for People With Lumbar Spinal Stenosis: a Randomized Controlled Trial

acronym: FLEXCAL

summary: The main objective of the study is to compare the efficacy on back-specific activity limitations at 4 months after-randomisation of home-based cycling using connected ergometric bicycles associated with usual care to usual care.

ReferenceCitation: Nguyen C, Boutron I, Roren A, Baron G, Pauwels C, Lefèvre-Colau MM, Poiraudeau S, Dupeyron A, Coudeyre E, Rannou F. Home-based cycling using connected ergometric bicycles for people with lumbar spinal stenosis (FLEXCAL): Protocol for a randomised trial. Ann Phys Rehabil Med. 2021 Mar;64(2):101351. doi: 10.1016/j.rehab.2019.12.006. Epub 2020 Jan 23.

location_facility: Assistance Publique - Hôpitaux de Paris, Service de Rééducation et de Réadaptation de l'Appareil Locomoteur et des Pathologies du Rachis, Hôpital Cochin


title: Effect of the Color of the Intra-eye Implant in the Cataract Surgery on the Sleep

acronym: IOL et sommeil

summary:
The cataract surgery (550 000 operations per year in France) is to replace the cloudy lens with a refractive implant. Two colors of implants are available: white implants, filtering out ultraviolet and yellow implants, filtering and more blue light. No clinical data are available to assert the superiority of an implant according to its color and the choice is made according to the preference of the surgeon and / or "markets".

It is established in humans that blue light has an important role on the secretion of melanopsin, a key mediator of the circadian cycle. This "clock" regulates most neuroendocrine functions in the nycthémère (sleep, mood, temperature, cortisol, ..). The question of the impact of these neuro endocrine functions of the installation of a blue light filter into the eyes of patients operated thus arises.

lead_sponsor: University Hospital, Tours

location_facility: Service d'Ophtalmologie, Centre Hospitalier Paul Martinais


title: Dose Reduction and Acquisition Parameters Optimization for PEDiatric Digital Radiography

acronym: DRAPOPED

summary: To reduce "As Low As Diagnostically Acceptable" (ALADA) the X ray exposure of pediatric radiology by using a new post treatment processing algorithm (S-Vue, Samsung table GC85A).

location_facility: Service de Radiologie Pédiatrique, C.H.U. Bicêtre, APHP


title: Impact of a Pharmacist's Intervention on Knowledge and Adherence to Biologic Disease-modifying Drugs in Patients With Spondyloarthritis: a Randomised Controlled Trial.

acronym: SPADHESION

summary:
There is a lack of knowledge among patients concerning their treatment with bDMARDs, which could lead to low adherence.

The objective of this study is to assess the impact of a pharmacist's intervention on the adherence to bDMARDs in patients with Spondyloarthritis.

primary_purpose: Other

lead_sponsor: Dr Ornella Conort

intervention_type: Behavioral


title: Impacts on Health Outcomes and Resources Utilization of Hospital-at-home for Elderly Patients With Multiple Myeloma

summary:
The study aims to compare the overall survival adjusted to quality of life of 2 groups of patients with multiple myeloma, depending on the type of care: (1) day hospitalization exclusively or (2) day hospitalization combined with hospital-at-home.

As secondary objectives, the study aims to compare the impacts of the two types of care organization on:

the survival of patients and response to treatments according to criteria of the International Myeloma Working Group,
psychological status of patients,
specific toxicity related to treatment used (haematological and infectious toxicity, neurotoxicity, ...),
health outcomes,
the caregiver's burden,

This study is combined with a qualitative study about the incentives and the barriers, and in order to set up the patient's typology.


title: Endocrine and Absorptive Intestinal Function in Patients at Two Years of Bariatric Surgery: Omega Loop Gastric Bypass Versus Roux-en-Y Gastric Bypass

acronym: MINIBHO

summary:
Gastric bypass with omega loop technic (OLGB) seems to be as effective as gastric bypass roux-en-Y (RYGB the reference) for the management of obesity and type 2 diabetes, but with less early surgical complications and more undernutrition in long terms.

This study aims to explore the profile of secretion of entero-insular hormone after a meal test in OLGB patient vs RYGB to understand the mechanisms of the improvement of type 2 diabetes after OLGB.

Secondary objectives are to better understand the absorptive function of the gut after a gastric bypass, to understand why is there more undernutrition in long term after OLGB than after RYGB.

time_perspective: Cross-Sectional

ReferenceCitation: De Bandt D, Rives-Lange C, Frigout Y, Bergerot D, Blanchard A, Le Gall M, Lacorte JM, Chevallier JM, Czernichow S, Poghosyan T, Carette C, Le Beyec J. Similar Gut Hormone Secretions Two Years After One Anastomosis Gastric Bypass and Roux-en-Y Gastric Bypass: a Pilot Study. Obes Surg. 2022 Mar;32(3):757-762. doi: 10.1007/s11695-021-05837-5. Epub 2022 Jan 7.

location_facility: AP-HP - Hôpital Européen Georges-Pompidou

intervention_type: Biological


title: Potentiation of Cisplatin-based Chemotherapy by Digoxin in Advanced Unresectable Head and Neck Cancer Patients

acronym: DIGHANC

summary:
Introduction: Patients with primary unresectable advanced head and neck squamous cell carcinomas (HNSCC) have a poor prognosis with a median survival of 22 months (Hauswald H Radiat Oncol 2011). They are usually treated with induction chemotherapy followed by radiochemotherapy or platinum-based concomitant radiochemotherapy. Most patients achieve an objective clinical response contrasting with a high rate of local recurrence and distant metastases in the year following radiochemotherapy (Argiris A Ann Oncol 2011). Improvement of the efficacy of chemotherapy remains therefore a major clinical goal for this group of patients. During the past years, the investigators demonstrated that some conventional chemotherapeutics (anthracycline, oxaliplatin…) induce a type of "immunogenic" cell death (ICD) characterized by the exposure of calreticulin on the tumor cell surface, the secretion of ATP and the release of high-mobility group box 1 (HMGB1) resulting in activation of tumor immunity (Galluzzi L Nat Rev Drug Discov 2012). The investigators recently showed that the Na/K-ATPase inhibitor, digoxin, favors ICD, when combined with cisplatin, a drug known not to induce ICD. In preclinical models, a synergy between cisplatin and digoxin which led to a significant therapeutic improvement (Menger L Sci Transl Med 2012) has been observed. This effect seems to be mediated by the immune system as the combined therapy induced intratumor T cell infiltration producing cytokines (Menger L Sci Transl Med 2012).

Hypothesis: Based on our preclinical data, the hypothesis is that adding digoxin to the conventional cisplatin based induction chemotherapy regimen in unresectable advanced HNSCC will increase the efficacy of this therapy via the induction of anti-tumor immunity.

Objectives:

Main: the primary objective is to assess the clinical and biological safety of the combination of digoxin to cisplatin-based chemotherapy.

Secondary: The secondary objectives are to investigate biological markers of efficacy by analyzing the recruitment of functional T cells in tumour biopsies after treatment with the combination of digoxin and chemotherapy.


title: Pilot Study to Evaluate the Effectiveness of Somatosensory Rehabilitation of Pain by Vibrotactile Stimulation on Static Mechanical Allodynia of Less Than Three Months Duration

acronym: RESISTAL

summary: This study aims to demonstrate that somatosensory rehabilitation of pain associated with static mechanical allodynia has superior efficacy over placebo treatment as well as over spontaneous changes.

lead_sponsor: CRRF La Châtaigneraie


title: Prospective Cohort Study: Prognosis and Risk Factors of Gastric Cancer in Patients With Intestinal Metaplasia

acronym: GASTRIMED

summary:
This prospective cohort study aims to assess the incidence of gastric cancer in patients with intestinal metaplasia in body of stomach or angular incisure.

As secondary objectives, among the patients included in the cohort, the study will:

assess the incidence of low grade dysplasia,
assess the incidence of high grade dysplasia in patients with low grade dysplasia,
identify risk factors of progression to dysplasia and gastric cancer.

location_facility: Service Hépato-gastro-Entérologie, Hôpital Ambroise Paré


title: Evaluation of the Impact of Within-hospital Trajectories of Patients Admitted in Intensive Care Units (ICU) From Emergency Departments

acronym: SUREA

summary:
This multicenter cohort aims to assess the impact of within-hospital trajectories of patients admitted in intensive care units from emergency departments on vital prognosis of patients, duration of hospital stay and hospital costs.

As secondary objectives, the study will:

assess the impact of clinical and demographic characteristics on hospital trajectories of patients.
assess the impact of emergency units workload, beds availability in medical units and in intensive care units, and global hospital organisation on patients care trajectories.

location_facility: Emergency Department, Bichat-Claude Bernard Hospital


title: A Phase III, Multicenter, Randomized, Controlled, Double-Masked Trial of NOVA22007 (Ciclosporin 0.1%) Ophthalmic Cationic Emulsion Versus Vehicle in Patients With Moderate to Severe Dry Eye Syndrome

summary: A Phase III, Multicenter, Randomized, Controlled, Double-Masked Trial of NOVA22007 (Ciclosporin 0.1%) Ophthalmic Cationic Emulsion versus Vehicle in Patients with Moderate to Severe Dry Eye Syndrome


title: Phase 1 Study of Temozolomide Associated With Topotecan in Refractory or Relapsed Malignant Tumors in Children and Adolescents

summary: Long term survival can now be achieved in 75% of cases of pediatric cancers. However, some types of tumors (ie CNS tumors) or advanced stages (metastatic sarcomas/neuroblastomas) cannot be cured by any treatment. Thus, evaluation of new drugs or combinations are strongly needed. The recommended doses have been defined in children for TMZ (200 mg/m2/d x 5 d) and TPT (1.5 mg/m2/d x 5 d). Some preclinical and clinical studies have shown activity of both drugs in some pediatric cancers. Nevertheless, the association of the two drugs has never been evaluated. The study aims to determine Maximum Tolerated Dose and dose limiting toxicities of each drug when associated and to assess efficacy of the combination.

lead_sponsor: Gustave Roussy, Cancer Campus, Grand Paris


title: Evaluation of a Kit for the Prediction of the Risk of Graft Versus Host Disease

summary:
This study is a proof of concept that will assess the Predictor's kit performances. The test will be performed by several technicians, in immunological laboratories of several sites in France.

In this study, "couples" of donor / recipient in the frame of a graft of CSH will be included.

primary_purpose: Prevention

lead_sponsor: Imagine Institute

location_facility:
Hôpital de Huriez / CHRU de Lille
Hôpital Necker Enfants Malades
Hôpital Haut-Lévèque
Centre Hospitalier de Caen


title: Long-term Efficacy of Doppler Ligation With Mucopexy in the Treatment of Internal Hemorrhoidal Disease

summary:
A classic distinction is made between internal and external hemorrhoidal pathology. External hemorrhoids can present with thrombosis, which causes painful swelling; internal hemorrhoids by rectal bleeding, prolapse, and more rarely thrombosis. Hemorrhoidal pathology is one of the most frequent reasons for consultation in proctology. Its prevalence is probably underestimated due to taboos and the frequent self-medication of patients, but it is considered high in the general population.

The therapeutic management of internal or external hemorrhoidal pathology is primarily based on hygiene and dietetic measures and regularization of transit. In the case of external hemorrhoidal pathology, treatment may also include Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) and topical treatment (anesthetic or topical corticosteroid). For internal hemorrhoidal pathology, when these measures are insufficient or when prolapse is present from the outset, instrumental treatment can be offered, allowing the bleeding and / or prolapse to be treated up to grade 3 maximum. This treatment includes sclerosis (less and less practiced), infrared photocoagulation and rubber band ligation. In 10 to 20% of cases, when the prolapse is irreducible, there is anemia of hemorrhoidal origin or the symptoms persist despite well-conducted treatment, surgical treatment may be offered.

The reference surgical technique in France and in Europe is tripedicular hemorrhoidectomy according to the Milligan and Morgan technique, developed at Saint Marks Hospital in London, first published in 1937. It has the advantage of to be the most effective technique, with a low rate of postoperative recurrence and treats both internal and external hemorrhoidal pathology. However, the postoperative period is painful, requires local care and requires cessation of activity for several weeks. On the other hand, there is a risk of potentially serious complications and permanent sequelae: acute retention of urine (2.1-15%), hemorrhage (0.6-5.4%), anal stenosis (6%) , infection (0.5-5%) and anal incontinence (0-6%). Patient selection is essential and contraindicates hemorrhoidectomy in cases of anal incontinence, active suppuration, chronic inflammatory bowel disease, anal intercourse or a history of pelvic radiotherapy.

As an alternative to hemorrhoidectomy, and its painful and restrictive consequences, new minimally invasive surgical techniques that have proven their effectiveness in the treatment of internal hemorrhoidal pathology have emerged over the past twenty years. The two main ones are Longo circular stapling hemorrhoidopexy and Doppler-controlled arterial ligations with mucopexy. Several studies have shown that Longo's hemorrhoidopexy causes less postoperative pain and allows a faster return to activity than after a tripedicular hemorrhoidectomy. On the other hand, the rate of recurrence of hemorrhoidal pathology was higher. This rate was 41% at 12 years and 47.5% at 15 years. In addition, specific and severe complications have been described as rectal perforations, rectovaginal fistulas, perirectal hematomas, pelvic cellulitis, peritonitis and death.

Several comparative studies have shown that arterial ligation under Doppler control with mucopexy was less painful postoperatively than hemorrhoidopexy by circular stapling and that the short- and medium-term efficacy was generally similar. In addition, the postoperative consequences of arterial ligatures under Doppler control with mucopexy seem harmless, with none of the major complications described after stapled hemorrhoidopexy. For these reasons, arterial ligation is now tending to replace hemorrhoidopexy with circular stapling.

The objective of our study is to assess the rate of recurrence of long-term hemorrhoidal pathology in patients who have had arterial ligatures under Doppler control with mucopexy at our center. The results will help guide the practitioner and the patient in the choice of surgical treatment.

ReferenceType: result

ReferenceCitation: Riss S, Weiser FA, Schwameis K, Riss T, Mittlböck M, Steiner G, Stift A. The prevalence of hemorrhoids in adults. Int J Colorectal Dis. 2012 Feb;27(2):215-20. doi: 10.1007/s00384-011-1316-3. Epub 2011 Sep 20.

ReferenceCitation: van Tol RR, Kleijnen J, Watson AJM, Jongen J, Altomare DF, Qvist N, Higuero T, Muris JWM, Breukink SO. European Society of ColoProctology: guideline for haemorrhoidal disease. Colorectal Dis. 2020 Jun;22(6):650-662. doi: 10.1111/codi.14975. Epub 2020 Feb 17.


title: Determination and Evolution of Usual Locomotion Strategies of Lower Limb Amputees by Gait Analysis

acronym: STRAAL

summary:
Amputation is a life-altering event with an immediate and obvious effect on daily life activities and quality of life. Asymmetrical movements of the lower limbs and compensatory strategies during walking are associated with an elevated risk for developing deleterious secondary health conditions. It is well established that therapeutic gait training methods are effective in reducing spatiotemporal gait deviations and improving functional mobility. However, the littérature does not clearly indicate the best time to perform a gait training or which gait parameters predict it.

The main aim of this study is to determinate the walking strategies of lower limb amputees in several locomotion tasks on daily life. Then, the investigators study the evolution of these walking strategies after a gait training and over time.

lead_sponsor: FondationbHopale

location_facility: Fondation HOPALE - Centre de rééducation Jacques CALVE


title: French National Registry of Congenital Dyserythropoietic Anemia

acronym: CDA

summary:
Congenital dyserythropoietic anemia is a heterogeneous inherited disease. Hyperplasic erythropoiesis is ineffective and associated with morphological abnormalities of some of the erythroblasts that form the basis of cytological classification. The cumulative incidence is not very clear, but varies between countries from 0.08 million in Scandinavia to 2.6 cases/million inhabitants in Italy where it appears to be the most reported.

The common manifestation is moderate chronic congenital anemia. This anaemia is either normocytic or discreetly macrocytic, non-regenerative or inappropriate regarding anaemia, contrasting with signs of hemolysis with moderate unconjugated hyperbilirubinemia. Diagnosis is usually made in the pediatric period, but because of the great heterogeneity, the diagnosis sometimes may be delayed. Splenomegaly and jaundice are mostly present. Secondary hemochromatosis is common in the absence of transfusion due to hyper-intestinal absorption of iron induced by the dyserythropoiesis.

The transmission mode for Type I and II is autosomal recessive, while it is autosomal dominant or sporadic for Type III.

Several clinical questions remain concerning this disease :

the median survival of patients is not well known, neither the causes of death
benefit/risk of splenectomy
iron overload quantification and consequences

The idea is to stablish a French registry of congenital dyserythropoietic anemia in order to help to understand the correlation between phenotype and genotype of this disease.

lead_sponsor: Lille Catholic University


title: Evaluation of a Preoperative Cognitive Behavioural Therapy (CBT) Program Based on Self-determination Theory for Bariatric Surgery Candidates : an Open-label Controlled, Randomized, Superiority Study

acronym: ACRoBAT

summary: The objective of this study is to evaluate the impact of a pre-surgical intervention program based on Cognitive and Behavioural Emotional Therapies, on the degree of dietary restriction of patients who are candidates for bariatric surgery in order to increase the long-term effectiveness of this kind of surgery

primary_purpose: Supportive Care

location_facility: • Lille Catholic University Hospital Group, Saint Philibert Hospital


title: Influence of Dental Occlusion on the Performance of High Level Rowers (IODPR)

acronym: IODPR

summary: Monocentric, prospective, randomized, open-label, cross-over study.

lead_sponsor: Rennes University Hospital


title: Measurement of Expiratory Flow Variability for the Detection of Bronchospasm in Infants Using the Ventica® Device by Revenio

acronym: VENTICA

summary:
Wheezing in infants and children less than 3 years of age children is a frequent feature that might be difficult to diagnose when only the caregivers reporting is available. Indeed, in this age group the usual reversible flow limitation measure during pulmonary function testing (PFT) is missing because PFT techniques require the full patient cooperation to perform respiratory tests. Infants PFTs have been developed to measure the same indexes than those measured in adults, but they are difficult to set-up and require medication- induced sleep during day time. However, when flow limitation is sufficient it can be detected during tidal breathing as measured during spirometry using pneumotachograph (PNT). In this test, the tidal breathing flow-volume (TBFV) loop is recorded and studied using different indices to assess the airflow limitation. But, there again, when addressing infants or very young children quiet breathing can only be achieved during sleep and medication- induced sleep necessary.

Impedance pneumography (IP) is a method for measuring changes in the thoracic electrical impedance through skin electrodes, which varies as a function of lung aeration i.e. breathing. This technique has mainly been applied to monitor respiratory rate in intensive care settings, but recent technical advancements in IP signal processing and electrode placement strategy have enabled IP to be used for accurate non-invasive tidal flow signal measurement. Compared to direct PNT, high agreement in flow signal and TBFV indices has been demonstrated in young children as well as in infants, even during induced bronchoconstriction. Moreover, in overnight recordings at home, IP was found feasible for quantifying nocturnal TBFV variability in young children with lower respiratory symptoms. In this study, it was shown that preschool children with high risk of asthma present with increased variation of tidal flow profile shape, and momentarily lowered chaoticity, compared to children with lower risk of asthma.

Recently a study in Tampere University Hospital (TAUH) Allergy centre (Tampere, Finland, PSHP ethical committee code R14027, ClinicalTrials.gov code NCT02164968) finished collecting overnight TBFV using impedance pneumography on 70 young children with suspected asthma. The preliminary analysis of this data shows that the effect of asthma treatment can be seen in TBFV variability, but to assess the diagnostic capacity of this new method, healthy control sample should be collected.

The technology developed by the Finnish medical device company Revenio Research Oy enables to evaluate the variability of the expiratory flow-volume curve. It is calculate as the expiration variability index (EVI) which is decreased in case of bronchoconstriction.

In order to explore very young children (less than 3 years of age) unable to participate to any awake lung function test, we set-up a study aiming to: 1) establish reference value for EVI in healthy children 2 months to 3 years old 2) test the variation of EVI in case of acute disease with or without wheezing in this age group children.

In this observational prospective multicenter study, we will include 110 asymptomatic healthy subjects to compute reference values of EVI. We will also include 35 previously healthy subjects who have developed an acute non wheezing disease such as fever, rhinitis, otitis or bronchitis to compare their EVI to the reference values. And finally, we will recruit 35 young subjects with an acute wheezing episode. All measurements will be performed at home by the parents, except for some wheezy children who could be hospitalized. It will be proposed to record 2 consecutive nights in healthy asymptomatic children in order to evaluate the night-to-night variability which has already shown to be small in older children.

In this multicentre study 120 children will be recruited by the present study in France and the remaining 60 children in another English centre using the same design and technology.

It is expected that only children with acute wheezing episode will have a significantly low EVI compare to the reference values established by this study.

lead_sponsor: Assistance Publique - Hôpitaux de Paris


title: Eighteen Months of Oral Anticoagulant Therapy Versus Placebo After 6 Six Months of Anticoagulation for a First Episode of Idiopathic Pulmonary Embolism: a Multicentre Double-blind Randomized Controlled Trial. "PADIS-PE" Study.

acronym: PADIS EP

summary:
Rational: After 3 or 6 months of oral anticoagulation for an episode of acute venous thromboembolism (VTE), the risk of recurrent VTE is high (10 to 15% per year) in comparison with a low risk of recurrence if VTE was provoked by a major transient risk factor such as recent surgery (3% per year) independently of the initial presentation (deep vein thrombosis or pulmonary embolism). After a first episode of idiopathic VTE, 3 months of anticoagulation is associated with a very high risk of recurrence (27% per year); however, the benefit-risk of extended duration of anticoagulation (1 to 2 years) remains uncertain, mainly in relation with an increased risk of anticoagulant related bleeding. Therefore, the last ACCP conference group recommended 6 months of oral anticoagulant therapy after a first episode of idiopathic VTE. However, this recommendation is likely to be inadequate for at least two main reasons: (1) no studies compared 2 years to 6 months of anticoagulation after idiopathic VTE; and (2), if the frequency of recurrent VTE is similar after deep vein thrombosis and pulmonary embolism, however, the case fatality rate of recurrent VTE is higher after pulmonary embolism (12%) than after deep vein thrombosis (5%).

Objective : the main objective is to demonstrate that, after 6 months of oral anticoagulation for a first episode of idiopathic pulmonary embolism, 18 months of warfarin therapy is associated with a lower cumulative risk of recurrent VTE and major bleeding in comparison with that on 18 months of placebo. The secondary objectives are: (1) to determine the risk of recurrent VTE after 6 months of warfarin therapy and the presence or the absence of residual lung scan perfusion defect and the persistence or not of elevated D-dimer test; and (2), to determine the impact of extended duration of anticoagulation on the risk of VTE after stopping anticoagulant therapy on a follow-up of 2 years.

Method : French multicenter double blind randomized controlled trial. Inclusion and exclusion criteria and pulmonary diagnostic criteria have been defined. After completing 6 months of oral anticoagulation, a lung scan and D-dimer testing are performed; the investigators and the patients will be unaware of the results of these tests. Then, patients are randomized to receive 18 months of warfarin therapy or 18 months of placebo (the dose of placebo will be adapted according to false computer generated INR). The investigators, the radiologists and the patients are blinded of the treatment allocation. The project will be submitted to national ethical committee and written consent will be obtained from all included patients.

Required number of patients: the expected cumulative frequency of recurrent VTE and major bleeding over 18 months is 4.5% while on warfarin therapy and 16% while on placebo. For a α risk of 5% (to falsely conclude to a true difference) and a β risk of 10% (to falsely conclude to an absence of difference), 178 patients per group should be included. As 5% of patients are expected to be loss, a total of 374 patients is required.

Feasibility: about 50 patients per year are hospitalized in our department of medicine in Brest for an acute episode of idiopathic pulmonary embolism. Four additional centers will participate to the study and have a similar recruitment: HEGP (Pr Meyer, Dr Sanchez), CHU Antoine Béclère (Dr Parent, Pr Simmoneau), CHU Saint Etienne (Pr Mismetti, Pr Décousus), CHU Grenoble (Pr Pison, Pr Carpentier). The study will be coordinated by the Clinical Center of Investigation of Brest Hospital; "true" and "false" INR will be generated by the clinic of anticoagulant of "Ile de France" (Dr Cambus).

Clinical implications: the first consequence of the study is to demonstrate that 6 months of warfarin therapy is inadequate and should be continued for at least 18 additional months after a first episode of idiopathic pulmonary embolism. This study has also the potential to confirm or not the contribution of lung scan and D-dimer testing to appreciate the risk of recurrent VTE after stopping anticoagulant therapy. Lastly, the medical economical impact of such therapeutic management will be evaluated.

ReferenceCitation: Raj L, Presles E, Le Mao R, Robin P, Sanchez O, Pernod G, Bertoletti L, Jego P, Lemarié CA, Leven F, Hoffmann C, Planquette B, Le Roux PY, Slaun PY, Nonent M, Girard P, Lacut K, Mélac S, Guégan M, Mismetti P, Laporte S, Meyer G, Leroyer C, Tromeur C, Couturaud F; PADIS-PE Investigators. Evaluation of Venous Thromboembolism Recurrence Scores in an Unprovoked Pulmonary Embolism Population: A Post-hoc Analysis of the PADIS-PE trial. Am J Med. 2020 Aug;133(8):e406-e421. doi: 10.1016/j.amjmed.2020.03.040. Epub 2020 Apr 22.

ReferenceCitation: Raj L, Robin P, Le Mao R, Presles E, Tromeur C, Sanchez O, Pernod G, Bertoletti L, Jego P, Leven F, Lemarié CA, Martin A, Planquette B, Le Roux PY, Salaun PY, Nonent M, Girard P, Lacut K, Melac S, Mismetti P, Laporte S, Meyer G, Leroyer C, Couturaud F; PADIS-PE Investigators. Predictors for Residual Pulmonary Vascular Obstruction after Unprovoked Pulmonary Embolism: Implications for Clinical Practice-The PADIS-PE Trial. Thromb Haemost. 2019 Sep;119(9):1489-1497. doi: 10.1055/s-0039-1692424. Epub 2019 Jun 23.

ReferenceCitation: Couturaud F, Sanchez O, Pernod G, Mismetti P, Jego P, Duhamel E, Provost K, dit Sollier CB, Presles E, Castellant P, Parent F, Salaun PY, Bressollette L, Nonent M, Lorillon P, Girard P, Lacut K, Guégan M, Bosson JL, Laporte S, Leroyer C, Décousus H, Meyer G, Mottier D; PADIS-PE Investigators. Six Months vs Extended Oral Anticoagulation After a First Episode of Pulmonary Embolism: The PADIS-PE Randomized Clinical Trial. JAMA. 2015 Jul 7;314(1):31-40. doi: 10.1001/jama.2015.7046.

lead_sponsor: University Hospital, Brest


title: Impact of Deprivation on Hospital Care Efficiency in Paediatrics

acronym: PRECAPED

summary:
Many studies have shown that deprived patients consumed more healthcare resources than non-deprived patients, in particular in terms of increased length of stay (LOS) and readmission rates, which has an impact on hospital efficiency and the healthcare system as a whole. There are many types of indicators available to assess deprivation in a hospital setting and French decision makers are currently using reliance on public aids to allocate additional funding to hospitals, based on the percentage of deprived patients they admit. However there are limits to this method: it only assesses one dimension of deprivation, the target population often does not know about the existence of those aids, and they have a clear threshold effect. An alternative solution is to use ecological deprivation indices which are obtained by aggregating different variables measured at a specific time and place, i.e. the patient's place of residence at the time of care. One such index, the FDep , was developed specifically in France, although others such as the Carstairs index and the European deprivation index also exist.

The primary objective of this study is to study the association between deprivation, measured by the FDep, and hospital care efficiency in paediatric and neonatology patients, measured by the difference between patient LOS and the national average LOS of their diagnosis-related group, DRG). The secondary objectives are to carry out a budget impact analysis on the impact of deprivation for hospitals with a paediatric or neonatology ward, to study the association between deprivation and readmission at 15 days, to study the relation between FDep and the currently used deprivation indicators, and to assess the added value of the FDep compared to those indicators and whether or not it should be used in routine practice.

In order to do so, an exhaustive retrospective study using the French hospital claims database will be carried out for the years 2012-2014. Deprivation indices will be calculated based on patients' postcode. The primary endpoint will be calculated using the national LOS present in the French national cost study. Similarly, the budget impact will look at the difference between production costs derived from the national cost study after adjusting for LOS and the statutory health insurance's tariffs, which will allow us to assess whether a hospital stay is associated with a gain, a loss or is budget-neutral for the hospital. Readmissions at 15 days will be identified through record linkage.

Descriptive analyses will summarise both hospital and patient characteristics. Uni- and bivariate analyses will be carried out by focusing of the variables of interest (e.g. average deprivation index by legal status of the hospital, mean LOS depending on the number of paediatric beds etc.). The deprivation index will be divided into quantiles as is the norm and the endpoints will be assessed for each of those quantiles. An ANOVA (or a Kruskal-Wallis test if the ANOVA hypotheses are not met) will test whether the results differ between each quantile. For readmission rates, a Chi² test will be performed.

In order to study the association between deprivation and the endpoints, the investigators will model each endpoint using as the main explanatory variable the deprivation index. Three main types of explanatory variables will be added to the model: patient characteristics (age, sex, severity level etc.), hospital characteristics (legal status, size, number of full-time equivalent etc.) and environment/context characteristics (number of paediatricians for 1,000 inhabitants, rural vs. urban area etc.).

In order to assess the added benefit of using the deprivation index vs. the current indicators, a sub-cohort will be constructed in Paris teaching hospitals (AP-HP) as unfortunately, whether the patient receives public aids is not present in the hospital claim database but is available only at the local level. The investigators will look at the distribution of patients with public aids in each quantile of the deprivation index and run the previous models using the two types of indicators one after the other and comparing the statistical performance of each pair of models.


title: Clinical Course and Changes in the Respiratory Microbiota Based on Antibiotic Treatment in Patients With Cystic Fibrosis

summary:
Bronchopulmonary infection is the most common and serious complication in the evolutionary course of cystic fibrosis (CF). Administration of antibiotics adapted to infecting pathogens is one of the key issues for its management. However, more than half of patients with CF have chronic respiratory infections for which infectious agent remains unknown leading to empirical antibiotic therapies that are not adapted to the causative agents. Recently, new technologies have been applied for the description and characterization of microbial agents in CF patients including molecular biology techniques that allowed us to detect and to identify new and/or emerging pathogens. Moreover, more sophisticated molecular techniques such as pyrosequencing and PCR amplification and cloning lead us to demonstrate the huge microbial diversity associated with chronic bronchopulmonary infections in this population. Otherwise, a metagenomic approach revealed the extraordinary complexity of the respiratory flora in these patients and, somewhat unexpected, abundance of anaerobes, viruses, and bacteriophages. In addition, it has been shown that some antibiotics commonly used in clinical practice for the treatment of respiratory infections were able to induce these bacteriophages, suggesting the existence of lateral gene transfer by transduction. The human microbiome is the set of microbial communities associated with the human body and represents all living microorganisms in the body. Its role in the immunity development has recently been demonstrated suggesting that changes in this ecosystem play a critical role in evolution of several human diseases. For example, in obesity it has been shown that there is a relationship between the intestinal human microbiota and nutritional and metabolic status of the hosts and specific alterations of these intestinal microbiota may represent a metagenomic signature of this disease. Evolution of the respiratory microbiota in patients with cystic fibrosis, whose nutritional status is often impaired (chronic malnutrition due to disorder of digestive absorption) and receiving regular antibiotic treatments remains unknown to date. Characterization of this ecosystem and its role is a critical step to understand the evolutionary course of the disease.

The main objective of this seminal study is to describe and to characterize the respiratory microbiota from sputum samples obtained from a limited number of selected patients with CF from 5 regional care centers (CRCM) from South of France (Mucomed network) (2 patients per center : 6 adults and 4 children), with similar clinical, microbiological and functional status before and after a cure of antibiotics. Different microbiological tools will be used including axenic culture systems, co-culture on amoebae in order to to isolate and to identify the microbial communities. Identification of bacteria will be done using MALDI-TOF mass spectrometry and/or molecular techniques. Moreover, 16S rRNA PCR amplification followed by cloning and sequencing of PCR products from the same sputum sample will be carried out to identify and to compare the bacterial species identified using molecular methods. In a second step, once the respiratory microbiota was characterized, it will be interesting to develop a dedicated microarray that will allow to detect all the bacteria identified in the first stage of the project and to assess its relevance on a larger cohort of patients with CF by studying the correlation between the respiratory microbiota and clinical status of patients according to the prescribed antibiotic treatments.

This study will open new clinical perspectives and will help us to determine the potential role of antibiotics on the microbiota evolution during treatment according to regional health care practices. This will contribute to better understand the role of the microbiota in the evolution of these chronic respiratory infections. It could be the first step for innovative therapeutic strategies, taking into account the balance of complex microbial flora and possibly evolving according to antibiotic therapies. It could also form part of a larger preventive strategy against transmission of specific pathogens in CF.

location_facility: Assistance Publique Hopitaux de Marseille


title: Randomized Study Estimating the Impact of a Personalized and Remote Support Centered on Exercise and Physical Activity for Patients After Breast Cancer

summary: A study that evaluates the benefits of a personalized remote exercise and physical activity coaching compared with the standard supportive approach in terms of health-related quality of life at 12 months in breast cancer survivors treated in an adjuvant setting.

lead_sponsor: Centre Oscar Lambret


title: Effectiveness of Mechanical Stimulation on Pain Level and Functional Discomfort Following a Total Mastectomy and Exploratory Axillary Surgery

summary: This study evaluates the effectiveness of mechanical stimulation technique compared to massages on pain level and functional discomfort (on the mobility of the shoulder) after 6 months, in breast cancer needing physiotherapy, following a total mastectomy and exploratory axillary surgery.


title: PROOF-OF-CONCEPT STUDY FOR NEW INTRAOCULAR LENS, MODEL C0002

summary: Prospective, two-arm, randomized, bilateral, subject/evaluator-masked clinical study to evaluate the distance visual acuity, peripheral refractive error and functional vision of the EPV IOL compared to a standard monofocal control IOL.

ipd_sharing_description: Johnson & Johnson Medical Device Companies have an agreement with the Yale Open Data Access (YODA) to serve as the independent review panel for evaluation of requests for clinical study reports and participant level data from investigators and physicians for scientific research that will advance medical knowledge and public health. Requests for access to the study data can be submitted through the YODA Project site at http://yoda.yale.edu

lead_sponsor: Johnson & Johnson Surgical Vision, Inc.

location_facility: Centre Hospitalier National d'Ophtalmologie


title: Expectations and Needs of Patients With Cystic Fibrosis Becoming Parents - Exploratory Study

acronym: MucoPar

summary:
The purpose of this study is to explore and collect the perceptions, expectations and needs of CF patients about parenting. This will be done in the context of several small groups of patients led by a psychologist who will ensure that all the participants express themselves; he will encourage them to develop their points of view, their divergences and their common points about what constitutes to be a parent.

The collected information should make it possible to develop and propose adapted medico-psycho-social interventions, if necessary, in connection with patient associations

location_facility:
Cochin Hospital
Foch Hospital


title: Analgesia by 50%/50% Nitrous Oxide/Oxygen Mixture for Nasogastric Catheterization in Children Aged 3 Months to 3 Years

acronym: SONGER

summary:
Since nitrous oxide/oxygen mixture is effective to reduce pain and anxiety induced by various painful procedures in children, the investigators hypothesized that its inhalation would reduce pain during nasogastric tube placement in young children.

The purpose of this study is to evaluate the analgesic efficacy of 50%/50% nitrous/oxide mixture in reducing pain induced by nasogastric tube insertion in children aged 3 months to 3 years in the pediatric emergency department.

location_facility: Poissy Hospital, Pediatric emergency department

location_facility: Trousseau Hospital, Pediatric emergency department


title: Study of Viral Transduction of Human Auditory Sensory Cells for the Development of Gene Therapy

acronym: TREATGENE

summary:
Gene therapy is a promising strategy to treat hearing loss and vestibular disorders, and Associated adenovirus (AAV) is shown as a good viral vector for inner ear therapy in animal models.

This study aims to study in vitro viral transduction of AAV in human inner ear cells, collected during non-conservative surgeries for vestibular schwannoma.

lead_sponsor: Institut Pasteur

location_facility:
Hôpital de Bicêtre
Hôpital Pitié-Salpétrière


title: Evolution of Tophus and Erosions of Hands and Feet With Urate-lowering Therapy: Prospective Study Using Dual-Energy Computed Tomography

acronym: TOPHERO-CT

summary:
The main objective is to evaluate the decrease in crystalline volume of the target tophus using Dual-Energy Computed Tomography (DECT), after 6 months +/- 1 month of urate-lowering therapy with target uricemia.

Study hypothesis

The dynamics of tophus resolution with urate-lowering therapy is poorly understood.
It is variable according to the location of the tophus, peri articular / intratendinous, but also probably at the feet / hands, the initial overall volume of the tophus, the initial crystal charge of the tophus. Knowledge of prognostic factors for tophus resolution will help determine the best target for treatment follow-up for each patient.
Erosions are the consequence of tophus. Tophus resolution could be associated with repair of erosions and stabilization of joint destruction.

location_facility: Radiology Department Lariboisière Hospital

location_facility: Reumatology Department Lariboisière Hospital


title: Does Optiflow Anesthesia Allow Anethesia Induction "Without Hands" ?

acronym: OPTIFLOW

summary:
Preoxygenation remains an important determinant of morbidity and mortality in anesthesia despite advances in mask ventilation and difficult intubation management.

The usual practice Preoxygenation prior to the injection of the anesthetic agents is the administration of pure oxygen to delay the occurrence of hypoxemia during the apnea phase and intubation maneuvers. It consists of applying a mask on the patient's face and allowing it to ventilate, ensuring a perfect seal of the device. The end of oxygen exhalation fraction is a good reflection of the alveolar oxygenation and a value of 95% corresponds to a "total" alveolar oxygenation. When this value is reached, the injection of the anesthetic agents (hypnotic, morphine and myorelaxant) leads to the loss of consciousness and apnea, which forces to continue the manual ventilation to the mask. Intubation is performed when the myorelaxation is complete.
Anesthetic induction "without the hands" The Optiflow Anesthesia (Fisher and Paykel Healthcare, Auckland, New Zealand) device provides heated, Humidified High-Flow Nasal Oxygen.

The hypothesis of this study is that Humidified High-Flow Nasal Oxygen, should allow anesthetic induction without having to impose the patient the establishment of a facial mask for several minutes before anesthetic induction and the doctor anesthetist assisted ventilation with the mask before intubation.

lead_sponsor: CMC Ambroise Paré

location_facility:
CMC Ambroise Paré
Hôpital Foch


title: Apneic Oxygenation Using Transnasal Humidified Rapid-Insufflation Ventilatory Exchange (THRIVE) in Adult Patients Undergoing Suspension Laryngoscopy Under General Anesthesia: a Multicenter Study

acronym: OxALa

summary:
Patients undergoing suspension laryngoscopy under general anaesthesia have oxygen delivered to their lungs through different methods. Inserting a tube in the trachea is the best means for oxygen delivery. However, it does not allow for optimal visibility of the operated area. Other techniques can be used but have disadvantages with some being associated with serious complications. No consensus exists regarding the best airway management technique for this intervention.

The aim of the study is to investigate a new device that delivers oxygen at very high flow through a nasal cannula in patients undergoing suspension laryngoscopy under general anaesthesia. This technique allows the surgeon to have a perfect visualisation of the laryngeal structures while allowing the delivery of oxygen for the lungs.

After informed consent, adult patients undergoing suspension laryngoscopy under general anaesthesia in two French hospitals will receive high flow oxygen throughout the procedure. At the end of surgery or, whenever applicable, at the time of technique failure (with a decrease in blood oxygen saturation to less than 92%), blood will be drawn for analysis. All patients will have a thin security catheter inserted in their trachea (the currently used technique in both participating hospitals), allowing for rescue high frequency ventilation if ever the study technique fails.

The safety of the device will also be assessed by analysing the blood samples for signs of carbon dioxide accumulation and by collecting any intra or post-operative complications.

If the device shows to be effective at maintaining blood oxygenation without significant associated risks, it could be used for other surgical situations where airway management is expected to be difficult.

location_facility:
Hôpital René Huguenin - Institut Curie
Hôpital Foch


title: Prospective, Multicentre Clinical Trial Measuring the Impact of Treatment With ALVEOGYL in Patients With Post-extraction Dry Socket

summary:
Alveogyl (Septodont, Saint-Maur-des-Fossés - France) is a Medical Device used as dressing in case of dry socket.

ALVE study is a clinical investigation measuring Alveogyl performance and safety in patients with post-extraction dry socket.

The study takes place in India and in France where Alveogyl is already marketed, since 2010 in France and since 2014 in India .

lead_sponsor: Septodont

location_country: India France

location_facility: Odontology Department - Pitié-Salpêtrière Hospital


title: A Phase I Multicenter Double-blind Placebo Controlled Dose Escalation Trial of an Adjuvanted Anti-CD40 mAb Fused to Env GP140 HIV Clade C ZM-96 (CD40.HIVRI.Env) Vaccine Combined or Not With a DNA-HIV-PT123 HIV-1 Vaccine in Healthy Participants

summary:
Multicenter double-blind placebo controlled phase I dose-escalation trial that will be conducted in France and Switzerland to evaluate different dose levels of CD40.HIVRI.Env (adjuvanted with Hiltonol) alone and in co-administration with DNA-HIV-PT123.

A total of 72 eligible healthy participants will be recruited into 6 groups. Within each group, participants will be randomized in a double blind manner to active intervention or placebo in a 5:1 ratio. Enrolment into a given group (other than group "Solo 0.3") will open sequentially depending on the " go-criterion " based on the safety data of the preceding group(s).

The primary objective is to assess the safety of three dose levels of CD40.HIVRI.Env (0.3; 1; 3 mg) adjuvanted with Poly-ICLC (Hiltonol®), alone and in combination with DNA-HIV-PT123, administered at weeks 0, 4 and 24 in healthy participants.

Secondary objectives are to assess the capacity of poly-ICLC-adjuvanted CD40.HIVRI.Env alone and in combination with DNA-HIV-PT123 to elicit immune responses against HIV (immunogenicity):

Humoral (antibody) responses ;
B-cell responses ;
T-cell responses.

lead_sponsor: ANRS, Emerging Infectious Diseases

location_country: France Switzerland

location_facility: Centre Hospitalier Universitaire Vaudois (CHUV)


title: Monitoring Electronique à Distance Des Patients Insuffisants Cardiaques

acronym: MEDIC

summary:
The main objective of the study is to evaluate the effect of telemonitoring on mortality and rehospitalization due to heart failure on patients with chronic heart failure which have follow an educational program compared to a conventional follow-up during 1 year.

The secondary objectives of the study are :

Evaluate the cost of health
Qualitatively evaluate telemonitoring on uses
Evaluate quality of life

lead_sponsor: Centre Hospitalier Universitaire de Besancon


title: Assessment of Metabolic and Immune Profiles in Patients Receiving Immune Checkpoint Inhibitors (ICI) for Advanced Renal Cell Carcinoma or Lung Carcinoma.

acronym: RIMEC

summary:
Recent EMA and FDA approvals have made immune checkpoint inhibitors (ICI) a standard of care in cancer treatment. ICI, used alone or as a combination are now the backbone of renal cell and lung carcinoma treatment. However, a significant proportion of patients does not respond to ICI. Thus the identification of predictive response factor is a major issue.

While factors associated with the tumour and its micro environment have been widely studied, factors associated with the patient such as metabolism could also affect the response to ICI and remain poorly studied.

The hypothesis of the investigators is that dysmetabolims, via the induction of a chronic inflammatory state could induce a defect of lymphocyte production and activation as well as a modification of the immunogenicity of tumor cells and immune cells infiltration. The consequences could be a decrease in ICI response rate as well as an increase in immune related adverse events (irAEs).

To test this hypothesis, the investigators propose a prospective bi-centric exploratory study including 60 patients treated with ICI for advanced lung or renal cell carcinoma.

The data collected will be :

Clinical (calorimetry, impedancemetry, survey of eating habits, tumour characteristics, epidemiological data),
Biologics (baseline and 3-months plasma bio banking for standard biology, inflammation markers TNF- α, IL1-6-8-11-17, TGF-ß, TWEAK, complement study C3, C4, C4d, CH50, C1q, CD46)

Primary objective is to assess the response to ICI depending on metabolic status.

Secondary objectives are to study the relationships between metabolism / cytokines profile/ complement profile and ICI response.

The investigators seek to generate hypotheses and to obtain exploratory data before submission of a Hospital Clinical Research Program whose objective will be to evaluate the impact of dysmetabolism on overall survival and to characterize immune and anatomopathological profiles (using DNA microarrays and flow cytometry techinques) of patients treated with ICI for renal cell or lung carcinoma.

location_facility: AP-HP - Hôpital Européen Georges-Pompidou Paris

intervention_type: Diagnostic Test


title: Study of Interindividual Variability in the Response to New Oral Direct Anticoagulants (Dabigatran Etexilate, Rivaroxaban or Apixaban) in Patients 80 Years Old and Over, Using a Population Pharmacokinetics Approach.

acronym: ADAGE

summary: Several new oral direct anticoagulants have been recently marketed. However, only a few, limited, studies have provided data about the pharmacology of new oral direct anticoagulants in older persons. This study try to better define wether the pharmacology of each of these 3 drugs (dabigatran, rivaroxaban and apixaban) is actually significantly different in very older patients (over 80) and to which extend. The investigators also try to characterize the main determinants (age, weight, renal function, co-morbidities, etc) of the variability observed between individuals in their response to he drugs studied. The method employed is a population pharmacokinetic/pharmacodynamic study.

lead_sponsor: Hôpital Charles Foix

location_facility:
Hôpital Charles Foix
Hôpital Européen Georges Pompidou


title: Use of CEST (Chemical Exchange Saturation Transfer) Imaging in PET/MRI

acronym: GlioCEST

summary:
Standard Magnetic Resonance Imaging (MRI) is based on the excitation of hydrogen nuclei that are presents in water molecules, which abundance in human body allows for obtention of superior contrast. However, assessing the presence of other molecules than water in tissues is also of great clinical interest to probe metabolites related to physiological body function and pathological conditions.

Chemical exchange saturation transfer (CEST) allow to overcome some limitations of proton magnetic resonance spectroscopy (1H-MRS) by exploiting chemical properties of the targeted molecule through a continuous process of re-saturation and exchange, and thus detecting it with increased sensitivity, from two orders of magnitude. Moreover, CEST technique is based on imaging sequences and can therefore benefit from well-known fast acquisition strategies, as well as improved spatial resolution.

location_facility: France Institut de cancérologie Strasbourg Europe


title: Feasibility Study on Laparoscopic Double-mesh Sacrocolpopexy With or Without Robotic Assistance, in Female Patients Presenting With Symptomatic Pelvic Organ Prolapse, Based on an Outpatient Treatment Model.

acronym: AMBULAPSE

summary:
Pelvic organ prolapse is an increasingly common functional disorder which affects approximately 30 to 40% of the female population, 12% of whom have a symptomatic form, with a psychological, physical and social impact. Laparoscopic sacrocolpopexy represents the surgical "gold standard" for the treatment of this functional disorder. It aims to suspend the vaginal vault by means of a prosthesis. The patient satisfaction rate is evaluated at 94% with low overall complication rate, evaluated at 11%.

Pelvic organ prolapse surgery is a common, with an estimated 30,000 procedures carried out in France in 2013 (excluding hysterectomy) (2013 ATIH data), and the number will increase in the future due to increasing life expectancy. 13% of women will undergo this type of procedure. The French General Directorate of Health Care Supply (DGOS) deems outpatient surgery to be the benchmark for surgical activity in all eligible patients, and has expressed the need for recommendations and tools for supporting its development. The rate of outpatient surgery for prolapse remains low in France (6.1%, 2015 ATIH data), while it is 25% in the US and 56% in Denmark. The average duration of hospital stays for DRG N81.2 (first degree uterine prolapse) in 2015 was 3.43 days. These procedures have been the subject of publications concerning outpatient care and involving low numbers of patients, with the exception of the publication by Sinhal which involved 111 patients.

ReferenceCitation: Drapier E, De Poncheville L, Dannappel T, Clerc P, Smirnoff A. [Day case laparoscopic sacral colpopexy for genital prolapse]. Prog Urol. 2014 Jan;24(1):51-6. doi: 10.1016/j.purol.2013.07.007. Epub 2013 Aug 13. French.

ReferenceCitation: Bump RC, Norton PA. Epidemiology and natural history of pelvic floor dysfunction. Obstet Gynecol Clin North Am. 1998 Dec;25(4):723-46. Review.

ReferenceCitation: Flam F. Sedation and local anaesthesia for vaginal pelvic floor repair of genital prolapse using mesh. Int Urogynecol J Pelvic Floor Dysfunct. 2007 Dec;18(12):1471-5. Epub 2007 Mar 17.

ReferenceCitation: Cuvelier G. [The ambulatory surgery, source of publications]. Prog Urol. 2013 Jun;23(7):427-9. doi: 10.1016/j.purol.2013.02.007. Epub 2013 Mar 26. French.

lead_sponsor: Centre Hospitalier Universitaire de Nice

location_facility:
CHU DE Nice - Hôpital l'Archet
Ch Lyon Sud
Hopital Antoine Beclere - Aphp
Chu de Nantes
Hopital Foch


acronym: FX-COVID

title: FX06 to Rescue Acute Respiratory Distress Syndrome During Covid-19 Pneumonia

source: euctr

location_facility: Service de Médecine Intensive Réanimation - CHI de Poissy

location_facility: Service de Médecine Intensive Réanimation - CHU Angers

summary:
Vascular leakage following endothelial injury, responsible for interstitial and alveolar edema, is a major feature of pathogen induced acute lung injury. As acute respiratory distress syndrome (ARDS) due to pandemic Covid-19 is associated with more than 60% mortality, controlling vascular leakage may be a major target to decrease the mortality associated with the spreading of the disease in France.

FX06, a drug under clinical development containing fibrin-derived peptide beta15-42, is able to stabilize cell-cell interactions, thereby reducing vascular leak and mortality in several animal models, particularly during lipopolysaccharide-induced and dengue hemorrhagic shock . A phase I study was conducted in humans, with no specific adverse event detected with a dose up to 17.5 mg/kg. In a phase II randomized multicentre double-blinded trial in 234 patients suffering from ST+ acute coronary syndrome, FX06 treated patients exhibited a 58% decrease in the early necrotic core zone. Importantly, adverse events were highly comparable between groups, indicating a high safety profile for the drug . Lastly, the drug was used as a salvage therapy in a patient exhibiting a severe ARDS following EBOLA virus infection . Altogether, those data indicate that FX06 is well tolerated in humans and is a potent regulator of vascular leakage.

Our hypothesis here is that FX06 may decrease pulmonary vascular hyperpermeability during ARDS following SARS-CoV-2 infection, thereby improving gas exchanges and the outcome of infected patients.


title: Cellular Effects of Training in Healthy Sedentary Subjects

summary: The purpose of this study is to understand underlying mechanisms of improved exercise tolerance in Healthy Sedentary Subjects after training program.

lead_sponsor: 5 Santé

location_facility:
Clinique du souffle La solane
hopital Arnaud de Vilneuve
Clinique du souffle La valonie


title: Predicting the Need for Intubation in Hospitalised COVID-19 Patients (PRED ICU COVID19)

summary:
One of the main challenges of the health crisis caused by the COVID-19 epidemic is the availability of beds in intensive care units (ICUs) and, more importantly, the need for invasive mechanical ventilation (IVM) because the ICUs are currently reserved for intubated patients.

The experiences of both China and Italy indicate that a certain number of COVID-19 patients will require mechanical ventilation. However, the limited number of resuscitation beds and ventilators requires strict use of these scarce resources. As a significant proportion about 5% to 10%, of patients initially admitted to hospital with COVID-19 will require ventilation, it is essential to anticipate their need for resuscitation to improve the rare resource of beds and ventilator shortages in intensive care units.

The hypothesis of the study is that, in proven or suspected hospitalised and oxygen-requiring COVID-19 patients, an early predictive clinical score, calculated over the three first days of admission may allow for an earlier identification of patients who will require intubation and transfer to an intensive care unit for orotracheal intubation

lead_sponsor: Central Hospital, Nancy, France

location_facility:
Brabois Hospital (CHRU de Nancy)
Louis Mourier hospital (AP-HP)


title: Epidemiology and Outcome of Anaphylactic Shocks Admitted to Intensive Care Unit: a French Retrospective Multicenter Study

acronym: ANAPHYLASHOCK

summary: Anaphylaxis is a severe life-threatening reaction following exposure to an antigen. Its incidence is progressively increasing in the general population over years, accompanied with an increased number of hospitalizations. Although rare, this condition is often associated with a significant morbidity and mortality. The mortality rate has been recently estimated at 0.84 (95% CI, 0.79 to 0.88) per million per year in the French adult population. Age, chronic medication and cardiac or pulmonary comorbidities have been reported to increase the risk of a severe reaction. Obesity, age and cardiovascular comorbidities have been identified as risk factors for fatal anaphylaxis. However, the risk factors for death after ICU admission have not been elucidated yet.

ReferenceCitation: Guerci P, Tacquard C, Chenard L, Millard D, Soufir L, Malinovsky JM, Garot M, Lalot JM, Besch G, Louis G, Thion LA, Charpentier C, Kimmoun A, Danguy Des Déserts M, Carreira S, Plantefeve G, Novy E, Abraham P, Mertes PM; Societe Francaise d'Anesthesie et Reanimation (SFAR) Research Network. Epidemiology and outcome of patients admitted to intensive care after anaphylaxis in France: a retrospective multicentre study. Br J Anaesth. 2020 Dec;125(6):1025-1033. doi: 10.1016/j.bja.2020.08.024. Epub 2020 Sep 12.

location_facility:
University Hospital of Nancy
University Hospital of Strasbourg


title: Prognostic Factors Associated With Mortality Within 6 Months Among Critically Ill Elderly Patients Admitted to the Intensive Care Unit With Severe Acute Cholangitis

acronym: ANGIOCHOLREA

summary:
The aging of the population goes along with an increased demand for intensive care among very elderly patients (above 75-80 years old). At the same time, there is a decline in the supply of intensive care units (ICU). The 1-year mortality of patients above 80 years old in ICU ranged from 40 to 70%. Moreover, many survivors suffer from long-term sequelae as poor quality of life, cognitive impairment and functional disability.

It is unclear under what conditions older patients may benefit from ICU admission. Cholangitis frequently occured in older patient. Moreover, severe acute cholangitis is a potentially life threatening disease characterized by a biliary obstruction and an infection of the bile possibly evolving towards systemic infection, shock and death. Because of its potential rapid reversibility of symptom thanks to early intravenous antibiotics and biliary decompression with drainage, old patients suffering from acute cholangitis are easily admitted to intensive care unit.

To date, there is a lack of data about the outcome in this population admitted to the intensive care unit with acute cholangitis.

The aim of the current study is to describe the outcomes in elderly patients (> 75 years old) admitted to the ICU with acute cholangitis and to identify prognostics factors associated with long term mortality (6 months).

ReferenceCitation: Novy E, Carrara L, Remen T, Chevaux JB, Losser MR, Louis G, Guerci P. Prognostic factors associated with six month mortality of critically ill elderly patients admitted to the intensive care unit with severe acute cholangitis. HPB (Oxford). 2021 Mar;23(3):459-467. doi: 10.1016/j.hpb.2020.08.003. Epub 2020 Aug 22.

location_facility:
CHR Mercy
Emmanuel NOVY


title: Outcome of Hodgkin Lymphoma Patients Over Than 60 Years Treated by Chemotherapy and/or Radiotherapy: a Retrospective Study

acronym: HODGSA

summary: Outcome of Hodgkin lymphoma patients over than 60 years treated by chemotherapy and/or radiotherapy: retrospective analysis.

location_facility:
CHU Dijon
CHRU Nancy


title: Epidemiologic Study of Persistent Polyclonal B-cell Lymphocytosis (PPBL) - Observatory 1990-2012

acronym: LPLB

summary:
The main purpose of this study is the description of all French cases of PPBL and the establishment of minimal criteria for the pathology diagnosis and its follow-up.

The secondary objective is the immunologic and genetic characterization of lymphoid cells causing the disease.

location_facility: group GFHC and intergroup LLC (GCFLL-MW / GOELAMS)