title: Comparison of Pharmacokinetic (PK) Levels Before and After Conversion From Twice-daily Tacrolimus to Once-daily Extended-release Tacrolimus (LCPT) in Diabetic Transplant récipients

acronym: SPK-PK

summary:
The investigators believe that the pharmacological properties of Envarsus®, well studied in kidney transplantation, may be also suitable after simultaneous kidney and pancreas transplantation than Prograf. Indeed, Envarsus® has demonstrated a clinical efficacy and safety in a complete clinical development plan.

This study is to establish the pharmacokinetic profile of tacrolimus prolonged-release (hereafter referred to as 'ENVARSUS®') in diabetics who have undergone kidney and pancreas transplantation, and compare it to the pharmacokinetic profile of standard twice-daily tacrolimus. The study will be conducted in 25 patients hospitalized at Nantes University Hospital.

lead_sponsor: Nantes University Hospital


title: Determination of a Trough Serum Concentration of Ofloxacin Associated to Increase in Side Effects Frequency in Elderly Treated for Bone and Joint Infection

acronym: ROSCO

summary: Ofloxacin is a gold standard antibiotic for the treatment of bone and joint infections due to sensible staphylococcus strains. However, in the elderly, inter-individual variability of the pharmacokinetics may reduce the efficacy or increase toxicity. The occurrence of ofloxacin side effects is likely to be increased in case of higher exposition. However, the serum concentration-toxicity relationship has not yet been determined. The purpose of this project is to assess the association between the residual serum concentration of ofloxacin at day 3 and the occurrence of at least one adverse effect attributable to ofloxacin, and determine a threshold toxicity concentration if this association exists.

study_start_date_type: Actual

status: Unknown status

study_completion_date_type: Anticipated

study_type: Interventional

primary_purpose: Treatment

enrollment_type: Anticipated

ipd_sharing: No

lead_sponsor: Centre Hospitalier Universitaire, Amiens

intervention_type: Biological

lead_sponsor_type: academique

status_simplified: Unknown


title: Restauration of the Auditory and Cognitive Functions in Cochlear Implanted Deaf Children in fNIRS

acronym: HearCog

summary: The principal aim of this study is to evaluate the cortical developement of perceptual skills and executive functions over time, in children with cochlear implants aged 10-24 months and 3-7 years compared with normally hearing subjects (NHS). To do this, the investigator will use functional Near InfraRed Spectroscopy (fNIRS) during 4 tasks that engage the childs perceptual and cognitive skills over a period of 18 months. The performance scores obtained by each participants as well as the cortical activity will be analysed and decrypted.

status: Recruiting

design_allocation: Non-Randomized

primary_purpose: Health Services Research

lead_sponsor: University Hospital, Toulouse

intervention_type: Behavioral

status_simplified: Ongoing


title: The Effect of Continuous Administration of Ropivacaine by Bi-laterosternal Multiperforated Catheters Placed Before a Sternotomy for Cardiac Surgery

acronym: Pre-BLS-Sterno

summary: The sternotomy site is the most painful site after cardiac surgery. Local infiltration of ropivacaine through the multihole catheters in the bilaterosternal position (BLS) after sternotomy significantly reduces pain at rest and during mobilization, reduces opioids consumption, decreases postoperative complications, improves patient comfort and satisfaction and reduced hospital costs. In this study our hypothesis is to test the efficacity of local anesthetic administration via the catheters in the BLS position placed before the surgical incision.

lead_sponsor: University Hospital, Clermont-Ferrand

location_facility: CHU Clermont-Ferrand - Service de Chirurgie Cardio-Vasculaire

intervention_type: Drug


title: Implementation of a Next-generation Sequencing Analysis of a Panel of Genes Implicated in Incomplete Forms of Albinism

acronym: DIA

summary: Implementation of a next-generation sequencing panel of genes to identify deleterious variants in patients with incomplete forms of albinism.

study_type: Observational

time_perspective: Prospective

lead_sponsor: University Hospital, Bordeaux

location_facility: Centre Hospitalier Universitaire de Bordeaux


title: Left Elective Colectomy in Renal Transplanted Patients : a Case-control Study (LECoRT Study)

acronym: LECoRT

summary:
Aim of the study :

To evaluate postoperative outcomes of elective left-sided colectomy in a renal transplanted population.

Methods :

From 2010 to 2015, all consecutive patients who underwent left elective colectomy in a referral center were prospectively collected.

Considering our exclusion criterial, data from 120 patients were analyzed. The cohort was separated into 2 groups : renal transplanted patients (KTR-group) and non-renal transplanted patients (C-group) Short and longterm outcomes were compared between the two groups.

Primary outcome :

90 days postoperative anastomotic leak rate

status: Completed

study_completion_date_type: Actual

time_perspective: Retrospective

enrollment_type: Actual

ReferenceType: derived

ReferenceCitation: Bardol T, Souche R, Genet D, Ferrandis C, Guillon F, Pirlet I, Fabre JM. Outcomes of elective left colectomy in renal-transplanted patients: a single-center case-control study (LECoRT study). Int J Colorectal Dis. 2021 Jun;36(6):1209-1219. doi: 10.1007/s00384-021-03860-7. Epub 2021 Jan 28.

ipd_sharing: Undecided

ipd_sharing_description: NC

lead_sponsor: University Hospital, Montpellier

intervention_type: Procedure

status_simplified: Completed


title: Evaluation of a Psycho-educational Program Based on the Prevention of the Risks Related to the Impact of Cognitive Disorders on Driving in Geriatrics and Neurology

acronym: ACCOMPAGNE

summary: ACCOMPAGNE study proposes to evaluate an educational program for the patient / caregiver dyad, intended to accompany the patient towards the implementation of self-regulation strategies in the driving activity. The program, based on group workshops with the presence of the patient and the caregiver, is led by an interdisciplinary team. It follows all the intervention recommendations described in the literature: to make the patient a decision-maker, to allow advanced planning of discussions between the family member and the caregiver, to give information on the consequences of TNCs and sensory disorders. This program provides psychological support in the management of the problems and the mourning of a future cessation of the driving activity, an awareness of the risky and avoidable situations, information on alternative solutions and available resources in the event of reduced driving. The program is created to support the implementation of self-regulation strategies for safe driving and a gradual reduction of driving activity. This study may be included in Measure 5 of the Neuro-Degenerative Diseases Plan (PMND) 2014-2019. This plan recommends to strengthen the self-management of patients and their relatives in the disease.

study_start_date_type: Anticipated

status: Not yet recruiting

design_allocation: Randomized

primary_purpose: Other

ReferenceCitation: Delphin-Combe F, Coste MH, Bachelet R, Llorens M, Gentil C, Giroux M, Paire-Ficout L, Ranchet M, Krolak-Salmon P. An innovative therapeutic educational program to support older drivers with cognitive disorders: Description of a randomized controlled trial study protocol. Front Neurol. 2022 Jul 18;13:901100. doi: 10.3389/fneur.2022.901100. eCollection 2022.

lead_sponsor: Hospices Civils de Lyon


title: Incidence of Rhinological Morbidities During Endonasal Pituitary Surgery, With or Without Nasoseptal Flap

acronym: HLNS

summary: Determine and compare prospectively the incidence of rhinological adverse events during pituitary surgery with or without nasoseptal flap

lead_sponsor: University Hospital, Brest


title: Evaluation of the Occurrence of Postoperative Surgical Site Infection in Otolaryngology Flap Surgery With Bone Graft, a Retrospective Analytic Study Between 2012 and 2019

acronym: SSI-flap

summary:
In 2017, the French Society in anesthesia and reanimation published new recommendations on intraoperative antibiotic prophylaxis. Now, no more than 48 hours of antibiotic prophylaxis applies to any otolaryngology surgery, regardless of patient's medical history or type of flap used to rebuild. This has resulted in an alignment of our local protocol in Croix-Rousse hospital.

However, after few years, our local impressions are that bone flap surgeries are very likely to provide surgical site infections (osteo-articular or non-osteo-articular infections).

The prejudice of these postoperative site infections is significant, with serious consequences,. of both functional and aesthetic sides.

We wanted to objectify this impression by retrospectively analyzing the data relating to patients operated on for bone flapsurgeries.

Knowing the operation site infection rate after surgery for otolaryngology bone flap surgery will allow us to objectively understand the infectious risk of these surgeries, in particular the risk of osteoarticular infection. Identifying operation site infection factors will allow us to better target and prevent them.

The goal is to find out if the antibiotic prophylaxis currently recommended is sufficient and effective for this type of surgery.


title: Comparison of Plasmatic Concentrations of Propofol and Remifentanil During Monitored Anesthesia in Obese and Non Obese Patients.

acronym: COCOPOPONO

summary: This prospective monocentric phamacokinetics study aims to compare plasmatic concentrations of Propofol and Remifentanil required to target a specific range of monitored anesthesia and analgesia during sus-mesocolic surgery in obese and non obese patients.

primary_purpose: Basic Science

location_facility: Service d'Anesthésie-Réanimation, Pôle Médecine Périopératoire - Hôpital Estaing, CHU de Clermont-Ferrand


title: Family Impact of Polyhandicap: Mixed Methodological Approach

acronym: PolyMiMe

summary: Polyhandicap (PLH) is a complex disability condition corresponding to a chronic affliction occurring in an immature brain, leading to the combination of profound mental retardation and serious motor deficit, resulting in an extreme restriction of autonomy and communication. In a preliminary work, we demonstrated that French families reporteda deterioration of the quality of life. This first study, based on a cross-sectional study and quantitative methods, did not allow to explore: 1) the dynamic aspect and the evolution over time of this experience, 2) the mechanisms underlying the difficulties encountered, the needs and expectations of families

lead_sponsor: Assistance Publique Hopitaux De Marseille

location_facility: Assistance Publique Hôpiatuix de Marseille


title: COVID-19 Infection Screening in Cancer Patients (NEOSCREENCOVID)

acronym: NEOSCREENCOVID

summary:
Since December 2019, outbreak of COVID-19 caused by a novel virus SARS-Cov-2 has spread rapidly around the world and became a pandemic issue. Cancer patients seem to be at higher risk of infection and evolution to severe forms related to immunosuppression, according to the first published data from Chinese experience. However, the role of confounding factors such as age and smoking habits cannot be independently assessed. Supplementary data from a large retrospective Italian cohort suggest that the proportion of cancer patients with severe form of COVID-19 could be lower than expected. In addition, the proportion of asymptomatic SARS-Cov-2 infected cancer patients is unknown. Based on academic and expert's recommendations, most of cancer units have already modified cancer treatment during the pandemic, in order to limit the number of outpatient visits / inpatient admissions and then reduce or avoid cross infection of COVID-19, although the negative impact on patient's outcome (cancer recurrence or mortality) has not been established. Thus, a large screening for SARS-Cov-2 infection in treated cancer patients could help to: - Define an accurate prevalence of COVID-19 immunization in this population - Aggregate data on the relationship between clinical characteristics in cancer patients and COVID-19 risk. - Provide information about asymptomatic COVID-19 cases. - Organize effectively cancer units to separate infected and non-infected patients.

The RT-PCR gold-standard test for COVID-19 on nasal and pharyngeal swabs has limitations, as the test is not universally available, turnaround times can be lengthy, and reported sensitivities vary. It does not provide information about immunization status. Serological assays may be important for understanding the epidemiology of emerging SARS-Cov-2, including the burden and role of asymptomatic infections. Thus, the development of new devices or techniques for accurate diagnosis of SARS-CoV-2 infections, of fast and safe use, that could be spread in the local hospitals and clinics, would be a major advance for identifying and treating patients. In addition, information about the immunization of fragile people, such as cancer patients, could help to plan a safe strategy for anti-cancer treatment schedule and for the end of quarantine.

primary_purpose: Screening

lead_sponsor: Centre Antoine Lacassagne

intervention_type: Other

lead_sponsor_type: industriel


title: Impact of Containment Measures in People With Eating Disorders: a Descriptive Study

acronym: COVITA

summary:
Since March 17, 2020, the French government has implemented national containment measures due to the COVID-19 epidemic. Quarantine is an unpleasant experience : Separation from relatives, loss of liberty, concern about the infectious status, boredom, can negatively affect mental health, with the emergence of anxiety and depressive symptoms.

In addition, confinement can disrupt usual physical activity, a major destabilization criterion for patients suffering from eating disorders (ED). Finally, conditions of confinement can harm social support, yet identified as a protective and resilience factor in stress contexts. Thus, the current context of confinement and social distances could be source of an increase in eating behavior disorders symptoms in people suffering from ED.


title: Evaluation of Discomfort Symptoms in Patients With Refractory Cancer Pain and Intrathecal Analgesia Management

acronym: IT-ESAS

summary: Intrathecal analgesia is used in refractory cancer pain because of drug sides effects or intractable pain. The aim of this approach is to improve pain management, and also to improve patient comfort. This study will assess patient discomfort symptoms before and after setting up intrathecal analgesia.


title: Seroprevalence and Immunoprotection Against SARS-CoV2 in Children Hospitalized in Paris

acronym: AP-PEDCOVID

summary: The paediatric population present mild or asymptomatic form of SARS-CoV-2 infection. This study asses the frequency of patients with SARS-CoV2 Antibodies (Ab) (seroprevalence) and the neutralizing typology of those Ab (immunoprotection) in children from 7 days to 18 years of age hospitalized for no more than 4 days and whose clinical status requires blood sample regardless of the symptoms Patients are included on a given day, after information, before blood sampling performed as part of the care. 500 µL of sera, normally discarded will be kept to perform SARS-Cov2 serology.

lead_sponsor: Hôpital Necker-Enfants Malades


title: Characterization of Postoperative Myocardial Lesions by Cardiac MRI and Anatomo-biological Correlations With Serum Troponin in Cardiac Surgery.

acronym: MITEC

summary:
Cardiac surgery under cardiopulmonary bypass (CPB) induces myocardial ischemia-reperfusion injury. This myocardial attack is a well-identified independent prognostic factor of postoperative morbidity and mortality. The quantification of these myocardial lesions by the postoperative plasma release of troponin has proven its diagnostic and prognostic value.

Cardiac magnetic resonance imaging (MRI) can accurately measure and characterize the size of myocardial lesions. These lesions are associated with a poor prognosis. MRI can also characterize myocardial edema secondary to ischemia-reperfusion which has not yet been studied in the context of CPB. It is therefore necessary, in a mechanistic approach, to quantify the respective share of necrosis, edema and reperfusion lesions during cardiac surgery under CPB in order to better understand these phenomena and to propose effective strategies for the prevention of these myocardial lesions.the relationship between the postoperative release of troponin and the amount of myocardial necrosis and edema measured by cardiac MRI will be assessed.The hypothesis is to demonstrate a positive correlation between imaging and biology in order to better understand the perioperative myocardial lesion processes.

This is an interventional study prospective, exploratory, in cardiac imaging, non-comparative and single-center, including 30 patients.


title: Detection of Urinary Tract Stones on Ultra-low Dose Abdominopelvic CT Imaging With Deep-learning Image Reconstruction Algorithm

acronym: URO DLIR

summary: Urolithiasis has an increasing incidence and prevalence worldwide, and some patients may have multiple recurrences. Because these stone-related episodes may lead to multiple diagnostic examinations requiring ionizing radiation, urolithiasis is a natural target for dose reduction efforts. Abdominopelvic low dose CT, which has the highest sensitivity and specificity among available imaging modalities, is the most appropriate diagnostic exam for this pathology. The main objective of this study is to evaluate the diagnostic performance of ultra-low dose CT using deep learning-based reconstruction in urolithiasis patients.

primary_purpose: Diagnostic

intervention_type: Diagnostic Test


title: Screening for Alcohol-related Cognitive Impairments in Cirrhotic Patients

acronym: CirCo

summary:
80% of patients with alcohol use disorders (AUD) present cognitive impairments, such as memory and executive functions. These disorders may have repercussions in addiction treatment by altering the patient's adherence to care. The level of impairment is dependent on the onset of addiction, and also the duration of abstinence.

A complete neuropsychological evaluation is necessary to highlight cognitive impairments. In practice, the evaluation of these disorders by practitioners, is done with the help of tools of screening like the MoCa (Montreal cognitive assesment) and the BEARNI (Brief evaluation of alcohol related neuropsychological impairment).

However, none of these tools have been evaluated in patients with alcoholic cirrhosis. Indeed, some studies have suggested that liver disorders including cirrhosis may be a factor aggravating cognitive disorders.

The purpose of this study is to evaluate the ability of the BEARNI tool to detect alcohol-related cognitive problems in patients with alcohol-related cirrhosis.


title: DELTA-CAPNO: Identification of Risk Factors for Alteration of the Cellular-arterial Gradient of CO2 in Pre-hospital Patients

acronym: DELTA-CAPNO

summary: Monocentric, prospective, observational and descriptive study on the evaluation of risk factors for alteration of the alveoarterial gradient of CO2 in pre-hospital patients, intubated and then ventilated in an invasive manner; and their impact on intra-arterial fatehospital.

lead_sponsor: University Hospital, Angers


title: Translation and Validation of the French Version of the ObsQoR-10 Questionnaire for the Evaluation of Recovery After Childbirth: the ObsQoR-10F Questionnaire

summary:
Until recently, there was no validated scoring tool to assess recovery after childbirth. Ciechanowicz et al. developed and validated a postpartum recovery score for women with a caesarean section (scheduled or unscheduled): the ObsQoR-11. The psychometric validation of the ObsQoR-11 confirms its reliability, its response to change, its acceptability and its feasibility (average filling time of 2 minutes, and the possibility to print the questionnaire on one page). The use of this score allows the investigators to quantify the quality of the patient's recovery between 0 and 110 (0 being a really poor recovery, and 110 a total recovery), by allocating a score from 0 to 10 for each item.

Since then, the initial version of ObsQoR-11 has evolved into a smaller version, ObsQoR-10, for which the pain items have been merged. Similarly, by assigning a score from 0 to 10 for each item, the ObsQoR-10 score allows to quantify the quality of the patient's recovery between 0 and 100 (0 being a very poor recovery, and 100 being full recovery).

There are currently no translations of this score into another language, but the investigators can easily assume that they will be done in the near future. French remains the fifth most spoken language in the world. The investigators therefore feel it is necessary to validate the translated version of the ObsQoR-10 score.

ReferenceType: background

ReferenceCitation: Ciechanowicz S, Setty T, Robson E, Sathasivam C, Chazapis M, Dick J, Carvalho B, Sultan P. Development and evaluation of an obstetric quality-of-recovery score (ObsQoR-11) after elective Caesarean delivery. Br J Anaesth. 2019 Jan;122(1):69-78. doi: 10.1016/j.bja.2018.06.011. Epub 2018 Jul 31.

ReferenceCitation: Sultan P, Kormendy F, Nishimura S, Carvalho B, Guo N, Papageorgiou C. Comparison of spontaneous versus operative vaginal delivery using Obstetric Quality of Recovery-10 (ObsQoR-10): An observational cohort study. J Clin Anesth. 2020 Aug;63:109781. doi: 10.1016/j.jclinane.2020.109781. Epub 2020 Mar 20.


title: Optimal Duration of Magnetic Resonance Imaging (MRI) Follow-up to Safely Identify Middle Ear Residual Cholesteatoma

summary: Previous studies demonstrated the high diagnostic value of non-echoplanar diffusion weighted magnetic resonance imaging (non-EP DWI) for residual cholesteatoma. However, limited data are available regarding a suitable length of imaging follow-up. The present study aimed to determine the optimal duration of non-EP DWI follow-up for residual cholesteatoma


title: P-glypoprotein Inhibition Effect on the Pharmacokinetics of Two Tacrolimus Formulations: Prolonged and Extended-release

acronym: DIPLOID

summary:
Tacrolimus is a drug administered orally available with different formulations: immediate release (Prograf®), prolonged-release (Advagraf®) and an extended-release one named LCP-Tacro (Envarsus®), formulated using the Melt-Dose process.

Tacrolimus is a lipophilic macrolide drug able to passive transmembrane diffusion. Its bioavailability displays a large interindividual variability, from 9 to 43%. Indeed, tacrolimus is a substrate of P-glycoprotein (P-gp) and cytochrome P450 3A4 (CYP3A4). P-gp is an efflux protein mainly located at the apex of the epithelia of the intestine, lymphocyte, kidney and blood-brain barrier. P-gp therefore limits the intestinal resorption of tacrolimus and also its diffusion into its target compartment (i.e the lymphocyte. The expression of this protein is different throughout the digestive tract with maximum expression at the ileal level. CYP3A4 is a coenzyme that is responsible of more than 90% of the metabolism of tacrolimus, at the digestive and hepatic level. Both P-gp and CYP3A4 play a role in tacrolimus absorption/diffusion process.

A new formulation of tacrolimus, LCP-Tacro, (Envarsus®) was approved in 2014. Its efficacy was compared to Prograf® in two phase III de novo or switch Prograf® trials in kidney transplantation.

With tacrolimus, there is a strong inter-individual pharmacokinetic variability which, to date, has not been fully characterized. Variations in bioavailability may partly explain this high variability. The different formulations are resorbed at distinct gastrointestinal sites which could explain different absorptions between Prograf/Advagraf and LCP-Tacro forms.

These findings raise the question of the role of P-gp in explaining the difference in bioavailability between formulations. The use of a P-gp inhibitor could therefore have a different impact on exposure to different galenic formulations.

Verapamil is an inhibitor of P-gp and CYP 3A4, which is frequently prescribed and recommended by FDA for drug-drug interaction studies aiming at evaluating P-gp substrates, used in healthy volunteers at dosages up to 240 mg/D13-14. Otherwise, verapamil-tacrolimus interaction has been characterized in vitro.

It has also been shown that inhibitory effect of verapamil at a single dose of 120 mg administered one hour prior to the administration of a P-gp substrate exhibited an optimum power of inhibition.

The safety of Advagraf® and Envarsus® administrations have already been subjected to several phase I trials in healthy volunteers reinforcing the knowledge of their safety profile.

The aim of the study is to compare the interaction profile of Advagraf® and Envarsus® when co-administered with verapamil in healthy subjects and to provide guidelines on tacrolimus dosage adjustment in such cases.

lead_sponsor: Rennes University Hospital

intervention_type: Genetic


title: Clinical Effectiveness of Hypertonic Sodium Lactate Infusion for Intraoperative Brain Relaxation in Patients Undergoing Scheduled Craniotomy for Supratentorial Brain Tumor Resection: Study Protocol of a Single Center Double-blind Randomized Controlled Phase II Pilot Trial

acronym: LSD

summary:
Resection surgery of brain tumors by craniotomy requires efficient brain relaxation intraoperatively in order to avoid injuries caused by the brain retractors (such as ischemic-reperfusion and cerebral oedema). The gold standard for the brain relaxation during a surgery is Mannitol 20%.

Molar sodium lactate is now used to induce brain relaxation in patients with traumatic brain injury and intracranial hypertension due to its osmotic effect. Furthermore, the injection of sodium lactate may lead to better neuronal metabolism during cerebral aggression, and may participate to the reduction of cerebral oedema and secondary injuries.

LSD is a pilot randomised trial which tries to assess the interest of intravenous administration of molar Sodium Lactate on the quality of brain relaxation in surgical resection of supratentorial brain tumors by craniotomy.

The primary outcome measure is the quality of brain relaxation, evaluated by neurosurgeon at the opening of the dura, by a validated brain relaxation scale.

ReferenceCitation: Todd MM, Warner DS, Sokoll MD, Maktabi MA, Hindman BJ, Scamman FL, Kirschner J. A prospective, comparative trial of three anesthetics for elective supratentorial craniotomy. Propofol/fentanyl, isoflurane/nitrous oxide, and fentanyl/nitrous oxide. Anesthesiology. 1993 Jun;78(6):1005-20.

ReferenceCitation: Besch G, Parmentier AL, Berthier F, Jaeg H, Villeneuve J, Hammoudi F, Scaringella N, Clairet AL, Vettoretti L, Chopard G, Thines L, Ferreira D, Samain E, Pili-Floury S. Clinical effectiveness of hypertonic sodium lactate infusion for intraoperative brain relaxation in patients undergoing scheduled craniotomy for supratentorial brain tumor resection: A study protocol of a single center double-blind randomized controlled phase II pilot trial. Medicine (Baltimore). 2022 Oct 7;101(40):e31038. doi: 10.1097/MD.0000000000031038.

ipd_sharing: Yes

lead_sponsor: Centre Hospitalier Universitaire de Besancon


title: Pathogens Involved in Secondary Infections During Severe Forms of Covid-19 Pneumonia: COVAP Study

acronym: COVAP

summary: A Respiratory infection with the SARS-CoV2 virus is associated with a major risk of viral pneumonia that can lead to respiratory distress requiring resuscitation. In the most severe forms, it may require mechanical ventilation or even lead to an acute respiratory distress syndrome with a particularly poor prognosis. The SARS-CoV2 is a single-stranded RNA virus of positive polarity and belongs to the beta genus of Coronaviruses. SARS-CoV2 is responsible for the third epidemic in less than twenty years secondary to a Coronavirus (SARS-CoV then MERS-CoV) and if the mortality associated with it is lower than that of previous strains, notably MERS-CoV, its spread is considerably big. As a result, the number of patients developing respiratory distress requiring invasive mechanical ventilation is high, with prolonged ventilation duration in these situations

status: Active, not recruiting

lead_sponsor: Groupe Hospitalier Paris Saint Joseph


title: Medical and Serological Follow-up of the Staff of the Paris Saint-Joseph Hospital Group

acronym: PERSO-COVID

summary:
The Coronavirus SARS CoV-2 (COVID-19) pandemic is causing a major global health crisis that is disrupting our hospital organizations and creating potential infectious risks for hospital staff on the front line when it comes to the support of infected people.

In this context, the Paris Saint-Joseph Hospital Group (GhPSJ) very early on wanted to implement an institutional approach aimed, on the one hand, at enabling each of its employees at its two sites (Hôpital Paris Saint-Joseph (HPSJ), Paris 14ème and Hôpital Marie Lannelongue (HML), Le Plessis Robinson, 92) to access their serological status with regard to SARS-CoV-2 and, on the other hand, to identify the risk factors for contracting COVID-19.

This collective approach consisted of an evaluation of its professional practices aimed at assessing the protective measures put in place to protect hospital personnel and identifying sources of potential improvement in the management of the infectious risk required to put in place in case of upcoming COVID-19 cases or any other epidemics in the future.

ReferenceType: result

ReferenceCitation: Janice Oh HL, Ken-En Gan S, Bertoletti A, Tan YJ. Understanding the T cell immune response in SARS coronavirus infection. Emerg Microbes Infect. 2012 Sep;1(9):e23. doi: 10.1038/emi.2012.26. Epub 2012 Sep 5. Review.

ReferenceCitation: Li G, Fan Y, Lai Y, Han T, Li Z, Zhou P, Pan P, Wang W, Hu D, Liu X, Zhang Q, Wu J. Coronavirus infections and immune responses. J Med Virol. 2020 Apr;92(4):424-432. doi: 10.1002/jmv.25685. Epub 2020 Feb 7. Review.

ReferenceCitation: Rajendran K, Krishnasamy N, Rangarajan J, Rathinam J, Natarajan M, Ramachandran A. Convalescent plasma transfusion for the treatment of COVID-19: Systematic review. J Med Virol. 2020 Sep;92(9):1475-1483. doi: 10.1002/jmv.25961. Epub 2020 May 12.

ReferenceCitation: Prompetchara E, Ketloy C, Palaga T. Immune responses in COVID-19 and potential vaccines: Lessons learned from SARS and MERS epidemic. Asian Pac J Allergy Immunol. 2020 Mar;38(1):1-9. doi: 10.12932/AP-200220-0772. Review.

ReferenceCitation: Salje H, Tran Kiem C, Lefrancq N, Courtejoie N, Bosetti P, Paireau J, Andronico A, Hozé N, Richet J, Dubost CL, Le Strat Y, Lessler J, Levy-Bruhl D, Fontanet A, Opatowski L, Boelle PY, Cauchemez S. Estimating the burden of SARS-CoV-2 in France. Science. 2020 Jul 10;369(6500):208-211. doi: 10.1126/science.abc3517. Epub 2020 May 13. Erratum in: Science. 2020 Jun 26;368(6498):.


title: Endocrine, Bone And Metabolic Disorders In Adults After Allogeneic Stem-cell Transplant

acronym: ENDOCALLOGREFF

summary:
Allogeneic hematopoietic stem cell transplantations (allo-HSCT) is often indicated in malignant hematologic diseases. Conditioning regimens, used to reduce the tumor burden and to prevent transplant rejection, are based on chemotherapy alone or combined with total body irradiation (TBI). Endocrine complications are frequent transplant-related side effects. Investigators have been well described in children studies but less in adulthood.

The objective of this study is to assess retrospectively endocrine, bone and metabolic disorders in adult patients, 12 months after allo-HSCT.

location_facility: CHRU de Brest - Endocrinology and Diabetology Department


title: European Study of Cerebral Aspergillosis Treated With Isavuconazole

acronym: ESCAI

summary:
Study clinical context Cerebral aspergillosis (CA) is a rare location of invasive aspergillosis (IA), associated with a high morbidity and mortality. Since 2002, voriconazole is the recommended first line treatment of invasive aspergillosis. More recently, isavuconazole appeared to be not less effective than voriconazole in the treatment of filamentous IFI, with a better tolerance profile.

The investigators aim to evaluate better the efficacy and the safety of isavuconazole in the treatment of cerebral aspergillosis by a descriptive, multicentric, international retrospective cohort study.

lead_sponsor: Imagine Institute


title: Immunohistochemical Study of Chordomas to Improve Their Diagnosis and Prognosis Care

acronym: CHORDOMES

summary: Chordomas are very rare malignant tumors, chemo-resistant with high propensity for recurrence. The role of immunotherapy in these patients remains largely unexplored while PD-L1 and CD8 status in the micro-environment of chordomas is basically not known. Similarly, this tumor often poses diagnostic difficulties due to its resemblance with metastasis or chondrosarcoma, thus, it would be useful to know the expression status of factors used during the work-up of metastatic or mesenchymal tumors, like CDX2, INSM1 and FOXA1, which remains unknown for chordomas. Thus, the aim of the study is to explore PD-L1, CD8, CDX2, INSM1 and FOXA1 expression in a series of chordomas and compare it with clinico-pathological and prognostic features.

lead_sponsor: Centre Hospitalier Universitaire de Saint Etienne


title: Shoulder Muscle Imbalance as a Risk Factor for Shoulder Injury in Elite Adolescent Badminton Players: a Prospective Pilot Study

acronym: BADEPAULE

summary:
Background: To assess the impact of pre-season clinical measures and rotator muscles strength on the risk of significant shoulder injury (SSI) in elite badminton players Design: Prospective cohort study Participants: Nineteen elite adolescents badminton players were included and followed over the badminton season (from september 2018 to may 2019 and/or from september 2019 to may 2020) .

Independent variables: A pre-season visit consisted in clinical and isokinetic shoulder strength testing. Clinical testing consisted in the shoulder range of motion (ROM) measurements and the table-to-acromion distance (TAD)Isokinetic internal and external rotator shoulder muscles strength was tested at 60 and 240°/s. Conventional and functional (eccentric-to-concentric) ratios (FR) were calculated. SSI collection was performed by an experienced sport physician.

lead_sponsor: University Hospital, Caen


title: Feasibility of Electromagnetic Navigation During Ultrasound Guided Foam Sclerotherapy for the Treatment of Venous Malformations.

acronym: SCLERONAV

summary: The aim of this study is to evaluate the feasibility of assisted electromagnetic navigation in percutaneous echo-guided sclerotherapy of slow-flow vascular malformations. Feasibility will be defined in terms of the percentage of patients for whom the procedure is successful.

intervention_type: Device


title: Place of Circulating Biomarkers and Respiratory Eicosanoids in the Prognosis of Severe Forms of Covid-19 Pneumonia: BioCovid Study

acronym: BIOCOVID

summary: The research is a prospective, multicentric (Groupe hospitalier Paris Saint-Joseph, Centre Hospitalier de Versailles André Mignot and Centre Hospitalier Victor Dupouy), non-interventional, prospective study. It aims at measuring eicosanoids at different stages of Covid-19 infection.

ReferenceCitation: Bradley BT, Bryan A. Emerging respiratory infections: The infectious disease pathology of SARS, MERS, pandemic influenza, and Legionella. Semin Diagn Pathol. 2019 May;36(3):152-159. doi: 10.1053/j.semdp.2019.04.006. Epub 2019 Apr 17. Review.

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

ReferenceCitation: Vijayanand P, Wilkins E, Woodhead M. Severe acute respiratory syndrome (SARS): a review. Clin Med (Lond). 2004 Mar-Apr;4(2):152-60. Review.

ReferenceCitation: Fehr AR, Channappanavar R, Perlman S. Middle East Respiratory Syndrome: Emergence of a Pathogenic Human Coronavirus. Annu Rev Med. 2017 Jan 14;68:387-399. doi: 10.1146/annurev-med-051215-031152. Epub 2016 Aug 26. Review.


title: Evaluation of the Incidence and Prevalence of Sarcopenia in Patients 70 Year and Older With Localized and Locally Advanced Porstate Cancer, Treated by Radiotherapy and Androgen Deprivation Therapy. a Monocentric Cohort Trial

acronym: HoSAGE

summary:
Prostate cancer is the most common cancer among men 50 years and older and mainly affets patients 75 years old.

Androgen deprivation therapy is indicatated in intermediates and high risks form of prostate cancer, in association with radiotherapy for 6 monts to 3 years. It is also indicated after surgery. Current therapies induce inhibition of sexual hormones as androgens among which testosterone. These therapies present side effects which have to be acknowledeged during the elaboration therapeutic startegies in older patients: hypogonadism induced by androgen deprivation therapy (ADT) causes loss of bone mineral density, diminution of lean body mass and increase of fat body mass.

Sarcopenia is defined by a loss of muscle strength associated to a decrease in skeletal muscle mass. In addition to aging, many factors may contribute to sarcopenia as cancer and/or ADT. This cohort study aims to evaluate risk factors associated to sarcopenia prevalence and the relationship between ADT and sarcopenia incidence, in patients 70 years or older with localized or locally advanced prostate cancer

ReferenceCitation: Couderc AL, Villani P, Berbis J, Nouguerède E, Rey D, Rossi D, Lechevallier É, Badinand D, Bastide C, Karsenty G, Boissier R, Amichi K, Muracciole X. HoSAGE: sarcopenia in older patient with intermediate / high-risk prostate cancer, prevalence and incidence after androgen deprivation therapy: study protocol for a cohort trial. BMC Cancer. 2022 Jan 18;22(1):78. doi: 10.1186/s12885-021-09105-8.

location_facility: Assistance Publique Hôpitaux de Marseille


title: External Validation of the Rotterdam Prostate Cancer Risk Calculator

acronym: PCaRisk

summary:
Prostate multiparametric MRI (mpMRI) can detect ISUP ≥2 prostate cancer with high sensitivity. Adding biopsies targeting suspicious lesions seen on mpMRI to the classical 'systematic biopsies' (that sample the gland in a blinded way) improves the detection of ISUP ≥2 cancers. As a result, it is now recommended to perform a prostate mpMRI before biopsy and to combine targeted and systematic biopsy.

However, mpMRI suffers from a lack of specificity. In a recent meta-analysis, the pooled sensitivity and specificity of prostate mpMRI for detecting ISUP ≥2 cancers were 0.91 (95% confidence interval, 0.83-0.95) and 0.37 (95% confidence interval, 0.29-0.46) respectively. Thus, accurate triage of patients suitable for biopsy might not be possible using mpMRI findings alone.

The Rotterdam Prostate Cancer Risk Calculator (RPCRC) combines mpMRI results (Prostate Imaging-Reporting And Database System score) and basic clinical and biochemical data to predict the results of prostate biopsy. If validated, this tool could help selecting patients for prostate biopsy.

In this study, the investigators propose to retrospectively use the data of the prospective multicentric MRI-FIRST trial (NCT0285379) to perform an external validation of the RPCRC.

In addition, the PCaRisk study has two secondary objectives:

To confirm that Prostate Specific Antigen density (i.e. PSA level divided by prostate volume) can stratify the risk of ISUP ≥2 cancer in patients with negative (PI-RADS 1-2) or inconclusive (PI-RADS 3) mpMRI, as suggested by recent literature
To perform a preliminary evaluation of a lobe-specific risk calculator developed by our group and combining mpMRI results and clinical and biochemical data to predict the risk of ISUP ≥2 cancer at the lobe level.

location_facility: Department of Radiology, Hôpital Edouard Herriot, Hospices Civils de Lyon


title: Infrared Thermography and Apgar Score: Evaluation in Delivery Room for Term Newborn

acronym: VIRGINA

summary:
Background: The Apgar score assesses the newborn's adaptation in the first minutes of life. It is rated between 0 and 10 by the midwife, at 1-3-5 and 10 minutes of life. A low Apgar score at 5 minutes of life is associated with increased neonatal mortality and neurological impairment. However, this score has limitations and its measurement remains subjective: it does not guide resuscitation actions in the event of poor adaptation, significant inter-observer variability in scoring, variations according to the physiological maturation of the newborn, in particular according to gestational age.

Infrared thermography is a rapidly developing imaging technique based on the measurement of infrared radiation. It is an accurate, reliable and easy instrument of providing rapid non-contact, non-invasive and non-irradiating diagnosis. A recent 2018 study showed that the use of thermography would allow accurate and non-invasive monitoring of newborns in neonatal intensive care unit for early diagnosis of certain pathologies such as infection. During the transition, during the first minutes of life, the circulatory and respiratory systems of the newborn change. Vasodilatation occurs progressively in the central and peripheral areas. Thermoregulation is also a crucial stage of adaptation.

In view of this physiopathological knowledge, it seems interesting to correlate this adaptation , with the analysis of thermographic images. The principle of this technique is indeed based on the analysis of the heat emitted, and would thus make it possible to evaluate the blood perfusion of the newborn, and its evolution in the first minutes of life in an objective way. Our hypothesis is that a poor adaptation could be detected more efficiently on photographs taken at time T, contrary to the calculation of the Apgar score for which there are several limitations mentioned above.

Main objective of the study: To study the ability of the thermographic image to objectively evaluate the adaptation to ectopic life of newborns compared to existing evaluations (Apgar, pH, Lactates).

time_perspective: Cross-Sectional

lead_sponsor: Poissy-Saint Germain Hospital


title: Platelet Activation by a Collagen Analogue in Hemorrhagic Situations

acronym: CAPTURE

summary: Dijon University Hospital and the Dijon-based NVH Medicinal Company have developed a recombinant mini-collagen NVH020B with platelet and Willebrand factor binding activity. Its small size and granular, non-fibrillar presentation make it suitable for use as an injectable hemostat in patients with a hemorrhage or other emergency under antiplatelet therapy.

lead_sponsor: Centre Hospitalier Universitaire Dijon


title: Achromobacter Spp: Description of Epidemiology and Resistance in Chronic Ear Infections and in Healthy Individuals.

acronym: AERIO

summary: Hearing loss can be the result of chronic ear infections. The role of bacteria of the genus Achromobacter is not known in these conditions. An epidemiological study including a large number of patients is needed to compare the prevalence of these bacteria in sick and healthy subjects, and to highlight the characteristics of the strains and the factors favouring their emergence.


title: Phase I Study, Prospective, Monocentric, Uncontrolled, Non-randomized, Open, Interventional. First Human Administration of an Inflammation Tracer (99mTc-cAbVCAM1-5) Using the Scintigraphy in Healthy Volunteers and Asymptomatic Patients.

acronym: ATHENA

summary:
Clinical Transfer of a Tracer of the Vulnerable Atheroma Plate: 99mTc-cAbVCAM1-5. (ATHENA).

This is a phase I/IIa, prospective, monocentric, non-controlled, non-randomized, open-label, interventional study.

ReferenceCitation: GBD 2016 Causes of Death Collaborators. Global, regional, and national age-sex specific mortality for 264 causes of death, 1980-2016: a systematic analysis for the Global Burden of Disease Study 2016. Lancet. 2017 Sep 16;390(10100):1151-1210. doi: 10.1016/S0140-6736(17)32152-9. Erratum in: Lancet. 2017 Oct 28;390(10106):e38.

ReferenceCitation: Little WC, Constantinescu M, Applegate RJ, Kutcher MA, Burrows MT, Kahl FR, Santamore WP. Can coronary angiography predict the site of a subsequent myocardial infarction in patients with mild-to-moderate coronary artery disease? Circulation. 1988 Nov;78(5 Pt 1):1157-66.

lead_sponsor: University Hospital, Grenoble


type: Other Identifier

title: Food Matrices Based on Fruit Pastes as Vectors of Carbohydrates for the Prevention and Management of Protein-energy Undernutrition in the Elderly: Proof of Clinical Concept

acronym: Fruisenior

summary: To develop more natural fruit pastes matrices that can effectively act as carbohydrate vectors in the elderly population and that are part of a normal diet while maintaining the pleasure of eating.

lead_sponsor: University Hospital, Clermont-Ferrand


title: Histological Prediction and Choice of the Resection Strategy in Front of a Colorectal Lesion > 2 cm: Prospective Comparison of Endoscopic Characterization, Non-targeted and Targeted Biopsies

summary: Colorectal cancer has become a public health priority considering its increased prevalence and high mortality rate when diagnosed late. As a consequence, many countries have promoted and uptaken of colorectal cancer screening programs leading to an increasing detection of advanced but also superficial lesions ESGE (European Society of Gastrointestinal Endoscopy) guidelines states that the majority of those colonic and rectal superficial lesions can be removed in a curative way by standard polypectomy and/or by EMR (Endoscopic Mucosal Resection) and that ESD (Endoscopic Submucosal Dissection) can be considered for removal of colonic and rectal lesions with high suspicion of limited submucosal invasion. Histologically, a resection is curative for the patient when the adenocarcinoma is well-differentiated (G1/G2), with a depth of invasion ≤ sm1 (≤ 1 mm submucosal invasion), with no lymphovascular invasion nor budding and with lateral and deep margins free of cancer

lead_sponsor: Hôpital Edouard Herriot


title: Comparison Between the Old Diagnostic Tools for Paediatric Undernutrition and the New HAS 2019 Recommendations

acronym: EDEN

summary:
Undernutrition is a widely under-diagnosed public health problem, including in pediatrics department. Undernutrition prevalence in pediatrics departments is about 15 to 20%.

Until now, there has been no national consensus on the criteria to be used to diagnose paediatric undernutrition. Until now, assessment focused on a range of non-consensus arguments that allowed the health care team to make its diagnosis. So, in the absence of well-defined criteria, diagnosis was based in part on experience and assesment team.

Since November 2019, the French High Authority of Health (Haute Authorité de Santé - HAS) has suggested recommendations to standardize pediatric undernutrition diagnosis.

The investigators offer to evaluate undernutrition prevalence differences diagnosed according to new HAS criteria compared to the previous diagnostic methodology.

The investigator's secondary aim is to identify profiles of children who do match between the two diagnostics methods.

lead_sponsor: University Hospital, Montpellier


title: Detection and Volumetry of Pulmonary Nodules on Ultra-low Dose Chest CT Scan With Deeplearning Image Reconstruction Algorithm (DLIR)

acronym: DLIRTHORAX

summary: evaluate the diagnostic performance of ultra-low dose CT using deep learning-based reconstruction in the detection of pulmonary nodules.

lead_sponsor: Centre Hospitalier Universitaire, Amiens

intervention_type: Radiation


title: ENDOCHAP Monocentric Cohort: Clinical and Molecular Study of Endometriosis and Adenomyosis

acronym: ENDOCHAP

summary: The purpose of this study is to determine whether endometriosis and adenomyosis are progressive diseases, in terms of symptoms (pain, abnormal uterine bleeding and infertility), anatomical lesions size, and recurrences. We also aimed to address molecular questions on immune dialogues between ectopic lesions and the eutopic endometrium, auto-immunity in endometriosis and adenomyosis and the role of the microbiota in their respective pathophysiologies.

lead_sponsor: Assistance Publique - Hôpitaux de Paris


title: Acute Renal Insufficiency (ARI) Rate and Predictive Score of ARI in Hospitalized Patients for Acute Coronary Syndrome With ST-segment Elevation Needing Urgent Coronarography

acronym: COROAKI

summary:
The primary objective of the study aims to evaluate frequence of acute renal insufficiency in patients with ST-segment elevation who need urgent coronary angiography in Ambroise Paré hospital.

The secondary objectives are:

identify factors of risks associated with the occurrence of acute renal insufficiency after coronarography.
establish a preprocedure score, predicting of acute renal insufficiency after urgent coronary angiography in patients with ST+ acute coronary syndrome.

location_facility: Nephrology department, Ambroise Paré hospital, APHP


title: Evaluation of Reporting of Road Traffic Accidents With Drugs Responsible for Cognitive and Psychomotor Side Effects (ERoADS)

acronym: ERoADS

summary: Drugs responsible for cognitive and psychomotor side effects may lead to impaired driving skills and road traffic accidents. This study investigates reports of road traffic accident for different class of drugs responsible for cognitive and psychomotor sides effects (pyschotropic agents, neurotropic agents, antineoplasic agents) in the World Health Organization's (WHO) global database of individual safety case reports (VigiBase).

ReferenceCitation: Chrétien B, Nguyen S, Dolladille C, Morice PM, Heraudeau M, Loilier M, Fedrizzi S, Bourgine J, Cesbron A, Alexandre J, Bocca ML, Freret T, Lelong-Boulouard V. Association between road traffic accidents and drugs belonging to the antiseizure medications class: A pharmacovigilance analysis in VigiBase. Br J Clin Pharmacol. 2022 Aug 8. doi: 10.1111/bcp.15481. [Epub ahead of print]

location_facility: Caen University Hospital, Department of Pharmacology


title: Study of the Technological and Operational Feasibility of a Remote Automated Monitoring System for the Post-operative Care of Surgical Patients

acronym: REDASUR

summary: In this clinical study, the investigators will compare vital parameters measurements obtained using continuous data from reference monitors and continuous wireless MultiSense® monitoring patch in 60 patients immediately after in-ward surgery and over 7 days.

lead_sponsor: IHU Strasbourg

location_facility: Service de Chirurgie Digestive et Endocrinienne, NHC


title: Observational and Monocentric Study of Complications in Adults With Cancer Receiving an Artificial Parenteral Nutrition in the Central Vein Initiated in Hospitalization

acronym: ONAC

summary: This observational study will evaluate the frequency of complications in adult cancer patients with central venous parenteral nutrition and the identification of aggravating factors.

ReferenceCitation: Touré A, Vanhems P, Lombard-Bohas C, Cassier P, Péré-Vergé D, Souquet JC, Ecochard R, Chambrier C. Totally implantable central venous access port infections in patients with digestive cancer: incidence and risk factors. Am J Infect Control. 2012 Dec;40(10):935-9. doi: 10.1016/j.ajic.2012.01.024. Epub 2012 May 26.

ReferenceCitation: Mermel LA, Allon M, Bouza E, Craven DE, Flynn P, O'Grady NP, Raad II, Rijnders BJ, Sherertz RJ, Warren DK. Clinical practice guidelines for the diagnosis and management of intravascular catheter-related infection: 2009 Update by the Infectious Diseases Society of America. Clin Infect Dis. 2009 Jul 1;49(1):1-45. doi: 10.1086/599376. Erratum in: Clin Infect Dis. 2010 Apr 1;50(7):1079. Dosage error in article text. Clin Infect Dis. 2010 Feb 1;50(3):457.

ReferenceCitation: O'Grady NP, Alexander M, Dellinger EP, Gerberding JL, Heard SO, Maki DG, Masur H, McCormick RD, Mermel LA, Pearson ML, Raad II, Randolph A, Weinstein RA. Guidelines for the prevention of intravascular catheter-related infections. The Hospital Infection Control Practices Advisory Committee, Center for Disease Control and Prevention, U.S. Pediatrics. 2002 Nov;110(5):e51.

ReferenceCitation: Ullmann AJ, Cornely OA, Donnelly JP, Akova M, Arendrup MC, Arikan-Akdagli S, Bassetti M, Bille J, Calandra T, Castagnola E, Garbino J, Groll AH, Herbrecht R, Hope WW, Jensen HE, Kullberg BJ, Lass-Flörl C, Lortholary O, Meersseman W, Petrikkos G, Richardson MD, Roilides E, Verweij PE, Viscoli C, Cuenca-Estrella M; ESCMID Fungal Infection Study Group. ESCMID* guideline for the diagnosis and management of Candida diseases 2012: developing European guidelines in clinical microbiology and infectious diseases. Clin Microbiol Infect. 2012 Dec;18 Suppl 7:1-8. doi: 10.1111/1469-0691.12037.

lead_sponsor: Institut du Cancer de Montpellier - Val d'Aurelle


title: "COTIDEA COmparison Between Continued Inpatient Treatment Versus Day Patient Treatment (Partial Hospitalization) After Short Inpatient Care in Early Onset Anorexia Nervosa: a Non-inferiority Trial A Non-inferiority Study"

acronym: COTIDEA

summary:
"In so-called ""early onset"" anorexia nervosa (AN), a rare and severe form affecting 8-13 year olds, experts recommend that, as soon as possible, treatment should take place on an outpatient basis, at an age when separation from the usual environment would be particularly unpleasant and deleterious. However, in severe AN, full-time hospitalisation (FTH) is still indicated when somatic and psychiatric instability criteria are met. Thus, the severity and rapidity of undernutrition in children aged 8-13 years suffering from AN (linked on the one hand to the frequency of total aphagia with refusal to drink and on the other hand to the lack of early detection of the disorder, frequently requires emergency FTH, contrary to expert recommendations. This FTH, which lasts on average 3 months in our specialized unit, has certain disadvantages: poor acceptability by the patient and/or his family, increased anxiety symptoms on entry and exit, school dropout, social isolation, coercive experience. In addition, the rate of premature FTH exits - before weight targets are reached - and the frequency of relapses after FTH remain high, making FTH unsatisfactory in terms of cost-effectiveness. Some families refuse FTH, which is classically long, exposing themselves to the risk of complications that can occur if the disorder is inadequately treated: somatic, acute and chronic complications; risk of progression to another eating disorder.

In recent years, day hospitalization (DH) care has been developed for adolescents aged 11 to 18 years and adults (Madden, 2015). The few studies available are in favour of comparable efficacy, better acceptability and lower cost in the management of moderate AN compared to prolonged FTH, but also better social adaptation.In children aged 8 to 13 years with AN, whose somatic condition requires continuous monitoring in a hospital setting (the usual indication for FTH), a DH cannot reasonably be proposed immediately given the severity of the situation. Our hypothesis is that it would however be possible, in these children, to shorten the duration of FTH and to continue DH treatment once the critical period has passed at the somatic level, with comparable efficacy, best acceptability, best progress in terms of school and social integration, and lower cost.


title: Assessment of the Risk of Pulmonary Embolism and Coagulation Profile in Patients With SARS Coronavirus (COV-2) Lung Disease

acronym: COVIDEP

summary:
The current severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) pandemic is complicated by pneumonia (15 to 20% of cases) requiring hospitalization with oxygen therapy. Almost 20 to 25% of hospitalized patients require intensive care and resuscitation; half die.

The main cause of death is acute respiratory distress syndrome (ARDS). However, some deaths have been linked to pulmonary embolism (PE).

Recognition of PE is important because there is specific treatment to limit its own mortality. The identification of biological parameters of hemostasis predictive of thromboembolic disease is crucial in these patients.

To evaluate the frequency of PE in the patients having to be hospitalized is to practice of a systematic thoracic angiography scanner in the patients having no contra-indication for its realization, as well as during hospitalization in patients deteriorating without any other obvious cause.

The thromboembolic events and disturbances of the coagulation system described in patients with SARS-CoV-2 pneumonitis suggest that this viral infection is associated with an increase in the activation of coagulation contributing to the occurrence of thrombosis and especially from PE.

lead_sponsor: Hopital Foch


title: Perceived Burden and Quality of Life of Primary Caregivers of Cancer Patients Aged 70 and Older After 5 Years of Management

acronym: FARAPPAC

summary:
Cancer is a disease that requires long-term management, especially now that medical advances have transformed most cancers from an acute to a chronic condition. Most of the time, therefore, the help provided by family and friends is long-term.

The negative impact of oncological care on the quality of life of family caregivers has already been studied. The UCOGB carried out a study in 2014 on the primary caregivers of cancer patients aged 70 and over at inclusion and at 3 and 6 months of oncogeriatric care. This study showed that several factors were significantly related to the caregiver's quality of life: the caregiver's age, perception of burden and patient autonomy (18). However, the evolution of quality of life and burden at 5 years has, to our knowledge, never been evaluated.


title: Effect of the Use of HYPNO VR on Pain Experienced During Chest Drain Insertion in Resuscitation Vigilant Patients.

acronym: VeRHiTY

summary: The main objective of this study is to evaluate, in vigilant resuscitation patients, the effect of the use of HYPNO VR on the pain felt during the insertion of a thoracic drain.

primary_purpose: Supportive Care

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


title: Prospective Evaluation of a Program for Early Identification of Needs and Multidisciplinary Intervention in Supportive Care in Digestive Oncology - DISSPO Parcours Dig' Study

acronym: DParcoursDig

summary:
Patients with advanced gastrointestinal (GI) cancers are very often sarcopenic/malnourished at diagnosis (> 60% of cases) and at high risk of rapid clinical deterioration. These patients have important supportive care needs that represent a major challenge for improving treatment tolerance and patient survival and health-related quality of life (HRQoL).

Malnutrition and sarcopenia (muscle wasting and dysfunction) are associated with an increased risk of death, complications from chemotherapy, infections, emergency procedures and hospitalizations, and increased costs of care. Therefore, malnutrition and sarcopenia represent a major clinical target in GI cancers.

Interventions targeting malnutrition/sarcopenia should be implemented as early as possible in patients' pathways, these syndromes being reversible at early stages but not at late stages.

A multidisciplinary assessment at diagnosis and therapeutic approach combining nutritional support and and adapted physical activity (APA) in addition to anticancer treatments should be systematically implemented in patients with advanced GI cancers.

This type of intervention complies with the standards recommended by the National Cancer Institute (INCa) to promote the practice of physical activity during and after treatment in oncology.

lead_sponsor: Institut Curie


title: Securing Access to Innovative Molecules in Oncology and Hematology for Children, Adolescents and Young Adults in Therapeutic Failure or Relapse and Not Eligible for a Clinical Trial: a Project of the SFCE

acronym: SACHA

summary: It involves collecting safety and efficacy data, under the actual conditions of use of medicines in children and adolescents, using a validated tool (VIGINOM) and relying on the network of Interregional pediatric oncology appeal organizations (OIR) identified by INCa since 2010 and responsible for the organization of Pluridisciplinary Pediatric Interregional (RCPPI) and National Consultative Meetings which discuss each case of relapse in order to define the best therapeutic options.

lead_sponsor: Gustave Roussy, Cancer Campus, Grand Paris


title: Screening of Clonal Hematopoiesis of Indeterminate Potential in Venous Thromboembolism

acronym: CHIPS

summary:
The aim of the study is to investigate the existence of clonal hematopoiesis of indeterminate potential (CHIP) in patients with a history of venous thromboembolism.

The study investigators make the assumption that these patients present mutations involved in CHIP occurrence.

lead_sponsor: Centre Hospitalier Universitaire de Nīmes


title: Verification of the Safety of Normal Food Before a Cerebral Arteriography

acronym: VIANAC

summary:
Fasting is currently required before elective cerebral angiography, despite numerous arguments against fasting (kidney toxicity, vasovagal reaction, discomfort) and seams unusefull regarding it's main goal : reducing nausea and vomiting. The investigators propose to assess frequency of nausea and vomiting among patients having taken their breakfast at home before day care angiography.

The investigators hypothesise that less than 1% of non fasting patients will suffer of vomitint.

lead_sponsor: Nantes University Hospital


title: Practice in Clinical and Molecular Thoracic European Pathology Laboratories During the COVID-19 Pandemic.

summary: The infectivity of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), notably when handling human samples, remains poorly understood, as well as the impact of the COVID-19 pandemic in routine clinical and molecular pathology practice, and for personal working in pathology laboratories. This study evaluates the consequences of the COVID-19 crisis in clinical and molecular pathology laboratories in Europe mostly those orientated for diagnosis of thoracic diseases.

lead_sponsor: Centre Hospitalier Universitaire de Nice


title: Correlation of VEGF-A and Fluid Balance in Septic Shock

acronym: VEGFluid

summary:
VEGF is a key molecule in the control of vascular permeability via interactions with the VEGF-receptor on the endothelial cell. Several authors reported plasma VEGF levels are elevated in sepsis shock and associated with increased mortality (1,2).

In septic shock, the main elements of treatment are intravenous fluids, appropriate antibiotics and vasopressors. Some authors observed positive fluid balance is associated with increased mortality rates in patients (3,4).

To the best of our knowledge, no studies have shown a correlation between VEGF levels and the fluid balance. The aim of our study was to determine the role of VEGF in capillary leakage and the positive fluid balance in septic shock.

lead_sponsor: University Hospital, Rouen


title: Use of Lung Ultrasound for COVID-19 Patient's Initial Triage Assessment and Early Monitoring: a Pilot Study

acronym: QUICK

summary: The QUICK study main aim is to assess the predictive value at Day 1, of a model built on lung ultrasound (LUS) and clinical data, both recorded at hospital admission of COVID-19 patients.

lead_sponsor: University Hospital, Toulouse


title: Effects of Silica and Asbestos Fibres on the Efferocytosis Capacities of Macrophages

acronym: MacFibOsis

summary: Evaluation of the efferocytosis capacities of blood Monocyte Derived Macrophages (MDM) from patients with a history of asbestosis or silica exposure and comparison of these capacities with those of MDM from healthy donors.

lead_sponsor: Rennes University Hospital


title: Erectus Nerve Block for Lumbar Spine Surgery : a Prospective Randomized Study

acronym: EFABE

summary: : Spine surgery induced severe postoperative pain. Several techniques as intravenous multimodal analgesia have been proposed to reduce pain relief and morphine rescue over the first postoperative days. Regional anesthesia using the erectus nerve block is a simple infiltration across lamina of the vertebra: Ultrasound-guided posterior ramus of spinal nerve block for anesthesia and analgesia in lumbar spinal surgery This study compared erector nerve block with local anesthetic vs placebo to reduce pain and morphine rescue after lumbar spine surgery. The investigators hypothesized that eructor nerve block induced a large block from L1 to L5 that induced posterior nerve roots block anesthesia. This block reduced pain after surgery.


title: Using the SpiderMass(TM) for in Vivo and Real Time Mass Spectrometry Analysis of Subject's Epidermis Suffering From Chronic Inflammatory Dermatosis Compared to Control Groups

summary:
The physiological states of the skin are characterized by a certain homeostasis linked to the balance of the metabolic pathways. When these pathways are deregulated, the proteic, lipidic and metabolic is affected. It is thus possible to follow a change in the state of the skin by looking at change in the associated molecular profile.

The PRISM laboratory (INSERM U1192) in Lille has developed an innovative system laser called SpiderMass composed of 4 parts:

A laser used for the micro-sampling of material in vivo,
A transport transfer line of the ablated particles,
A mass spectrometer that analyzes them in real time and generates the molecular profiles of the epidermis,
A data analysis procedure.

The SpiderMass(TM) is of great interest for the study of the skin because it allows non-invasive vivo characterization, and therefore without biopsy or sample preparation. In addition, it will complement techniques already used in the research center such as FTIR spectroscopy. Indeed, in acne studies the FTIR allows to obtain only the Fatty Acid Triglycerid ratio while the SpiderMass permits to detail these lipid classes by each observed molecule on the surface of the skin and follow their evolution.

lead_sponsor: Pierre Fabre Dermo Cosmetique


title: Early Verticalization of the Patient With Acute Respiratory Distress Syndrome: Assessment of Feasibility and Safety.

summary:
Acute Respiratory Distress Syndrome (ARDS) is defined according to the Berlin definition (1) as diffuse lung damage occurring in patients with a predisposing risk factor.

Positioning in the prone position (PP) has been shown to decrease mortality in patients with moderate to severe ARDS.

However, this technique is not without deleterious effects such as ventilator-associated pneumonia, endotracheal tube obstruction, development of pressure ulcers, and increased workload for the caregivers.

There are other positioning techniques such as the "upright" position, which simulates a relative verticality, which allows to increase the effects of the prone position and even in some patients to improve oxygenation without the PP in the acute phase of ARDS.

However, given the revolution caused by the use of PP in ARDS patients, verticalization have not been studied in more details.

Today, there is a bed on the market that allows patients to be truly upright without having to transfer them to a tilt table.

The investigators believe that raising ARDS patients in the acute phase is safe and feasible in routine practice. In this research protocol comparing PP and verticalization in a crossover trial design in acute ARDS patients, the investigators want to show that this technique can be safe and feasible, with the same effects on oxygenation as PP.

ReferenceCitation: Umbrello M, Formenti P, Bolgiaghi L, Chiumello D. Current Concepts of ARDS: A Narrative Review. Int J Mol Sci. 2016 Dec 29;18(1). pii: E64. doi: 10.3390/ijms18010064. Review.

lead_sponsor: Centre Hospitalier Régional d'Orléans


title: Analyse of Tumour and Constitutional DNA for the Study of the Determinism in Child Neoplasia

acronym: ALADIN

summary:
Background. Cancer is the leading cause of death by disease in children. Most pediatric tumors differ from adult tumors in terms of biological and clinical characteristics. In children, the part of genetic determinism could be higher since the role of environmental factors may be less pronounced than in adults and that a young age at onset is a main feature of genetic cancer predisposition. Recent studies suggested that a number of genetic predisposition remains to be characterized.

Methods. Trio-Based whole exome sequencing of germline DNA from patients (children and adults diagnosed with cancers between 0 and 17 years) and parents will be performed prospectively in a multicentric study including 40 unselected cases of malignant tumor. Participating hospitals will include the CHU of Montpellier, the CHU de Nice and the AP-HP. Tumor analysis will include whole exome analysis and transcriptome for the identification of therapeutic target and contribute to confirm potential link between constitutive mutations and tumor phenotype (such as loss of expression, loss of heterozygosity).

Perspectives. This pediatric oncology study proposing a global approach integrating trio-based whole exome sequencing, somatic DNA and RNA analysis will improve the recognition of genetic predisposition and the characterization of target therapies in children with cancer.

primary_purpose: Prevention

lead_sponsor: University Hospital, Montpellier


title: Evaluation of the Effect of Music on Young Practitioner's Stress During Endodontic Treatment

acronym: MUSIQUENDO

summary:
According to several studies, patients consider endodontic treatment as one of the most stress-inducing dental procedures. Two studies demonstrated that music enables the patient to be less stressed during RCT.

RCTs are also stressful for the practitioner, and particularly for students who start their dental practice. Endodontic and prosthetic cares are considered the most demanding by students. RCT requires high degree of precision in gestures and patience because those technical acts are, in part, blindly realised and can be long. In a preliminary study, it was found that the most stress-inducing steps for the students during endodontic treatment are root-canal preparation and filling.

The beneficial side of listening to music on the patient's stress during RCT has been proved; but to our knowledge, no study assessed the effect of listening to music on the stress of the practitioner and more particularly of the young practitioner, during endodontic treatment, and in particular during root canal preparation. This is the main aim of this study.

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

lead_sponsor: University Hospital, Brest


title: Real Time Surveillance of Pediatric Infectious Diseases in French Ambulatory Care: PARI Study

acronym: PARI

summary: Many ambulatory networks are mainly based on diagnoses made by first-line physicians not specifically trained to join the network. Here we aim to set up a surveillance network on pediatric infectious diseases with an investment in teaching with specific trainings of participating pediatricians, increasing in use of point of care tests, and automated data extraction from the computers of the pediatricians.

ReferenceCitation: Cohen R, Béchet S, Gelbert N, Frandji B, Vie Le Sage F, Thiebault G, Kochert F, Cahn-Sellem F, Werner A, Ouldali N, Levy C. New Approach to the Surveillance of Pediatric Infectious Diseases From Ambulatory Pediatricians in the Digital Era. Pediatr Infect Dis J. 2021 Jul 1;40(7):674-680. doi: 10.1097/INF.0000000000003116.

lead_sponsor: Association Clinique Thérapeutique Infantile du val de Marne


acronym: POLYbio

title: Association Between Methotrexate Erythrocyte Polyglutamate Concentration and Biological Drug Concentration and Clinical Response in Rheumatoid Arthritis Patients Treated With Subcutaneous Injectable Methotrexate and a First Biological Drug

lead_sponsor: Centre Hospitalier Universitaire de Saint Etienne

type: EudraCT Number

source: euctr

summary: The combination of methotrexate (MTX) with a biological disease-modifying antirheumatic drugs (bDMARD) is the next step in treatment with MTX monotherapy in rheumatoid arthritis (RA). Estimation of MTX and bDMARD impregnation could be performed with the erythrocyte MTX polyglutamate (MTX-PG) and bDMARD assays before to move to a second bDMARD. In RA patients treated with MTX (prescribed for at least 6 months at a stable dose for at least 3 months) in combination to a first bDMARD (prescribed since at least 3 months), an assay of MTX-PG and bDMARD will be performed in tow subsets of RA according to the level of disease activity. The first subset is active RA defined by a DAS28 (disease activity score 28)>3.2. The second one is RA in clinical remission defined by a DAS28<2.6. The main hypothesis is the association between the low concentration of MTX-PG and the clinical response of RA patients treated with subcutaneous methotrexate injection associated to a first bDMARD. Adherence to MTX will be reviewed by the Compliance Questionnaire Rheumatology (CQR) questionnaire. This assay could be useful to improve MTX management before to move to a second bDMARD.


title: Thyroid Biological Toxicity and Tumor Response in Patients Treated With NIVOLUMAB 2nd Line in Non-small Cell Bronchopulmonary Cancer

acronym: THYRONIVO

summary: This is an observational, retrospective and monocentric study, conducted at the university Hospital of Brest The primary objective is to assess the association between the occurrence of thyroid dysfunction in patients treated with Nivolumab® for a non-small cell lung cancer and prognosis and therapeutic response The second objective is to assess prognosis and therapeutic response according to severity and subtype of thyroid dysfunction

ipd_sharing_description: All collected data that underlie results in a publication


title: Inflammation, Intracellular Invasion and Colonization of the Nasal Mucosa by Staphylococcus Aureus

summary:
An inflammatory state of the nasal cells (very close to keratinocytes) could favour the internalization of Staphylococcus aureus and thus constitute a persistent reservoir for the carriage of this bacterium.

Staphylococcus aureus is a commensal bacterium of the skin and mucous membranes that colonizes approximately 2 billion people worldwide Staphylococcus aureus is also a leading cause of community and healthcare-associated infection. Staphylococcus aureus has demonstrated its ability to invade many non-professional phagocytic cell lines such as keratinocytes, osteoblasts, fibroblasts, epithelial cells and endothelial cells. During pro-inflammatory stimulation, internalization of Staphylococcus aureus into keratinocytes is mainly mediated by ICAM-1. These results suggest that, in humans, an inflammatory state of the nasal cells (very close to keratinocytes) could promote the internalization of Staphylococcus aureus and thus constitute a persistent reservoir for the carriage of this bacterium.


title: Trial Studying the Feasibility of a Diet Modification in pAtients With Luminal Early Breast Cancer Candidate for Primary Surgery

acronym: MACS

summary:
to analyze the feasibility for patients with early luminal breast cancer to be compliant with a diet modification - ketogenic or proteins restricted diet - during 9 +/- 1 days, before breast cancer surgery.

It's a Pilot study, monocentric, randomized

ReferenceCitation: Kushi LH, Doyle C, McCullough M, Rock CL, Demark-Wahnefried W, Bandera EV, Gapstur S, Patel AV, Andrews K, Gansler T; American Cancer Society 2010 Nutrition and Physical Activity Guidelines Advisory Committee. American Cancer Society Guidelines on nutrition and physical activity for cancer prevention: reducing the risk of cancer with healthy food choices and physical activity. CA Cancer J Clin. 2012 Jan-Feb;62(1):30-67. doi: 10.3322/caac.20140.

ReferenceCitation: Rock CL, Doyle C, Demark-Wahnefried W, Meyerhardt J, Courneya KS, Schwartz AL, Bandera EV, Hamilton KK, Grant B, McCullough M, Byers T, Gansler T. Nutrition and physical activity guidelines for cancer survivors. CA Cancer J Clin. 2012 Jul-Aug;62(4):243-74. doi: 10.3322/caac.21142. Epub 2012 Apr 26. Review. Erratum in: CA Cancer J Clin. 2013 May;63(3):215.

ReferenceCitation: Cairns RA, Mak TW. Fire and water: Tumor cell adaptation to metabolic conditions. Exp Cell Res. 2017 Jul 15;356(2):204-208. doi: 10.1016/j.yexcr.2017.04.029. Epub 2017 Apr 27. Review.

ReferenceCitation: Vander Heiden MG, DeBerardinis RJ. Understanding the Intersections between Metabolism and Cancer Biology. Cell. 2017 Feb 9;168(4):657-669. doi: 10.1016/j.cell.2016.12.039. Review.

ReferenceCitation: Chen Y, Ling L, Su G, Han M, Fan X, Xun P, Xu G. Effect of Intermittent versus Chronic Calorie Restriction on Tumor Incidence: A Systematic Review and Meta-Analysis of Animal Studies. Sci Rep. 2016 Sep 22;6:33739. doi: 10.1038/srep33739.

ReferenceCitation: Fontana L, Partridge L. Promoting health and longevity through diet: from model organisms to humans. Cell. 2015 Mar 26;161(1):106-118. doi: 10.1016/j.cell.2015.02.020. Review.

ReferenceCitation: Lv M, Zhu X, Wang H, Wang F, Guan W. Roles of caloric restriction, ketogenic diet and intermittent fasting during initiation, progression and metastasis of cancer in animal models: a systematic review and meta-analysis. PLoS One. 2014 Dec 11;9(12):e115147. doi: 10.1371/journal.pone.0115147. eCollection 2014.

ReferenceCitation: O'Flanagan CH, Smith LA, McDonell SB, Hursting SD. When less may be more: calorie restriction and response to cancer therapy. BMC Med. 2017 May 24;15(1):106. doi: 10.1186/s12916-017-0873-x. Review.

ReferenceCitation: Weber DD, Aminzadeh-Gohari S, Tulipan J, Catalano L, Feichtinger RG, Kofler B. Ketogenic diet in the treatment of cancer - Where do we stand? Mol Metab. 2020 Mar;33:102-121. doi: 10.1016/j.molmet.2019.06.026. Epub 2019 Jul 27. Review.

ReferenceCitation: A D B. The Ketogenic Diet in Epilepsy. Can Med Assoc J. 1931 Jan;24(1):106-7.

lead_sponsor: Institut du Cancer de Montpellier - Val d'Aurelle

intervention_type: Dietary Supplement


title: Interest of the Dosage of Ferritin / Glycosylated Ferritin in COVID-19

summary:
Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is a new coronavirus responsible for the pandemic called coronavirus disease 2019 (COVID-19), which appeared in China in December 2019 and which has spread rapidly around the world. Even if in the vast majority of viral infection results in a mild illness, it can also progress to a severe form with sometimes fatal consequences.

Indeed, clinical worsening, between the 7th and 10th days of the onset of symptoms, has been widely described since the start of the pandemic. This manifests itself at the biological level by hyperinflammation (VS, CRP, ferritin), coagulopathy (elevation of D-dimers, sometimes disseminated intravascular coagulation) and cell lysis (CPK, LDH).

At the same time, it was observed high levels of pro-inflammatory cytokines (IL-1β, IL-6, TNF-α, IL-18), suggestive of a cytokine storm, and the first studies on therapeutic management targeting these cytokines are currently underway in COVID-19.

Such a profile strongly recalls on the one hand the cytokine release syndrome (CRS, observed in CAR-T cell therapy in malignant hematology), and on the other hand the lymphohistiocytic activation syndrome (SALH). Systemic diseases, such as adult Still's disease and its pediatric side, can also be complicated by a cytokine storm, known as macrophagic activation syndrome (SAM, equivalent to secondary SALH). Under all these conditions, IL-1β, IL-18, IFN-γ and IL-6 seem to be key mediators of hyperinflammation.

Plasma ferritin is a biological marker of inflammation, long known, associated with various infectious, hematological and immunological conditions. An increase in ferritin levels has in particular been associated with an unfavorable development in certain infections such as influenza and certain authors have moreover shown an association between plasma ferritin and the evolution towards ARDS or death in patients. Its dosage is also used as a diagnostic tool for SAM, and could make it possible to differentiate the latter from severe sepsis in intensive care. Some authors have also noted it as a prognostic factor in Kawasaki disease or CRS.

The plasma dosage of ferritin, associated with that of its glycosylated fraction, could therefore be a diagnostic (difference between SAM and severe sepsis in intensive care), prognostic (evolution towards ARDS, mutation in intensive care, mortality) and therapeutic (indication of preemptive treatment with an inhibitor of IL-1 or IL6) in patients infected with SARS-CoV-2.

The objective of this study is to retrospectively assess the prognostic value of ferritin and glycosylated ferritin in SARS-CoV-2 infection in hospitalized.

lead_sponsor: Hospices Civils de Lyon


title: Effect of Milk Consumption, Containing A2 β-caseins Only, on Digestive Comfort. A Randomized and Double-blind Study

summary:
Lactose, naturally present in milk, can cause digestive discomfort. Delactosed milk is currently the only one alternative to cow's milk for intolerant people. As some of them do not digest milk, it was completely remove from their diet. However, are they really intolerant to lactose or intolerant to milk (or to another of its compounds)? Do β-caseins play a role in this intolerance? β-caseins are proteins naturally present in milk. Two types of β-caseins were identified: A1 and A2. These types differ according to the genetic profile of the cow and depend on the breed. The rare clinical studies interested in this topic suggest that:

consumption of milk A1 versus consumption of milk A2 can lead to: softer stools, delayed transit, as well as pro-inflammatory effects in some individuals,
consumption of A2 milk significantly reduces gastrointestinal symptoms and improves digestive comfort in lactose intolerant people.

Thus, it would be interesting to be able to assess the effect of a consumption of A2A2 milk type compared to A1A2 milk type, both on the parameters of digestive comfort and on inflammatory parameters.

lead_sponsor: Institut Pasteur de Lille


title: Bioequivalence Study of Vigabatrin ORPHELIA Pharma 500mg Soluble Tablets and SabrilTM 500mg Granules for Oral Administration

summary:
Methodology:

The study was an open label, randomized, crossover, 2 periods study in 20 healthy male/female volunteers. Subjects received 500 mg of the new formulation of soluble tablets vigabatrin or Sabril, as single oral administration in 2 different study periods depending on the randomization, with a 7-days wash out period between administrations

lead_sponsor: Orphelia Pharma


title: Impact on Mortality of an Oxygenation Strategy Including Standard Oxygen Versus High Flow Nasal Cannula Oxygen Therapy in Patients With Acute Hypoxemic Respiratory Failure: a Prospective, Randomized Controlled Trial.

acronym: SOHO

summary: First-line therapy of patients with acute respiratory failure consists in oxygen delivery through standard oxygen, high-flow nasal oxygen therapy through cannula or non-invasive ventilation. Non-invasive ventilation in acute hypoxemic respiratory failure is not recommended. In a large randomized controlled study, high-flow nasal oxygen has been described as superior to non-invasive ventilation and standard oxygen in terms of mortality but not of intubation. Paradoxically in immunocompromised patients, high-flow nasal oxygen has not been shown to be superior to standard oxygen. To improve the level of evidence of daily clinical practice, we propose comparing high-flow nasal oxygen versus standard oxygen, in terms of mortality in all patients with acute hypoxemic respiratory failure

ReferenceCitation: Frat JP, Quenot JP, Badie J, Coudroy R, Guitton C, Ehrmann S, Gacouin A, Merdji H, Auchabie J, Daubin C, Dureau AF, Thibault L, Sedillot N, Rigaud JP, Demoule A, Fatah A, Terzi N, Simonin M, Danjou W, Carteaux G, Guesdon C, Pradel G, Besse MC, Reignier J, Beloncle F, La Combe B, Prat G, Nay MA, de Keizer J, Ragot S, Thille AW; SOHO-COVID Study Group and the REVA Network. Effect of High-Flow Nasal Cannula Oxygen vs Standard Oxygen Therapy on Mortality in Patients With Respiratory Failure Due to COVID-19: The SOHO-COVID Randomized Clinical Trial. JAMA. 2022 Sep 27;328(12):1212-1222. doi: 10.1001/jama.2022.15613.

lead_sponsor: Poitiers University Hospital


title: Early Cognitive Assessment and Evolutionary Monitoring of Patients With Severe ARDS (Acute Respiratory Distress Syndrome) on SARS-CoV2 Viral Pneumonia Requiring Mechanical Ventilation

acronym: CognitiVID

summary:
The new coronavirus pandemic responsible for the severe acute respiratory syndrome SARS-CoV2 requires, in its severe forms, the use of invasive ventilation in intensive care.

The first patients seen in intensive care presented with neurological symptoms and usually not seen in non-viral ARDS or due to other viral causes. These were mainly restless awakenings, attempts at self-extubation and confusional syndromes. Although the data in the literature do not seem to reveal the presence of SARS-CoV2 in the CSF of these patients, certain elements seem to show parenchymal brain damage with the description of hypometabolism of the frontal regions. In addition, most of these patients present a memory complaint after going into intensive care (personal data not published).

We do not know to date what is the cognitive and psychic profile of these patients, nor what will be their future evolution. Some patients may require specific neuro-cognitive rehabilitation.

The aim of this study is to assess the cognitive profile of patients infected with COVID-19 who have used invasive ventilation in the intensive care unit of Paris Saint-Joseph hospital since April 2020, in order to be able to compare them between them and follow their evolution in the medium term. This work could make it possible to describe the specific cognitive impairment of SARS-CoV2, by trying to evade other causes of cognitive disorders in patients hospitalized in intensive care for respiratory distress (hypoxia, treatments, metabolic disorders, etc.).

The main objective is to follow the medium-term evolution between 3 and 6 months of the cognitive profile of patients with severe form of SARS-CoV2 with the use of ventilatory resuscitation.

ReferenceCitation: Alkeridy WA, Almaghlouth I, Alrashed R, Alayed K, Binkhamis K, Alsharidi A, Liu-Ambrose T. A Unique Presentation of Delirium in a Patient with Otherwise Asymptomatic COVID-19. J Am Geriatr Soc. 2020 Jul;68(7):1382-1384. doi: 10.1111/jgs.16536. Epub 2020 May 16.

ReferenceCitation: Helms J, Kremer S, Merdji H, Clere-Jehl R, Schenck M, Kummerlen C, Collange O, Boulay C, Fafi-Kremer S, Ohana M, Anheim M, Meziani F. Neurologic Features in Severe SARS-CoV-2 Infection. N Engl J Med. 2020 Jun 4;382(23):2268-2270. doi: 10.1056/NEJMc2008597. Epub 2020 Apr 15.

ReferenceCitation: Bouattour N, Farhat N, Hadjkacem H, Hdiji O, Sakka S, Dammak M, Mhiri C. [Five-word test calibration in a Tunisian population of healthy subjects]. Pan Afr Med J. 2019 Sep 30;34:58. doi: 10.11604/pamj.2019.34.58.14472. eCollection 2019. French.

ReferenceCitation: Maillet D, Matharan F, Le Clésiau H, Bailon O, Pérès K, Amieva H, Belin C. TNI-93: A New Memory Test for Dementia Detection in Illiterate and Low-Educated Patients. Arch Clin Neuropsychol. 2016 Dec 1;31(8):896-903. doi: 10.1093/arclin/acw065.

ReferenceCitation: Vialatte de Pémille C, Ray A, Michel A, Stefano F, Yim T, Bruel C, Zuber M. Prevalence and prospective evaluation of cognitive dysfunctions after SARS due to SARS-CoV-2 virus. The COgnitiVID study. Rev Neurol (Paris). 2022 Oct;178(8):802-807. doi: 10.1016/j.neurol.2022.03.014. Epub 2022 May 13.

lead_sponsor: Groupe Hospitalier Paris Saint Joseph


title: Treatment of Common Bile Duct Stones in a Laparoscopic Center : What Are the Limits and When Should we Call the Endoscopist ? Observationnal Study Between 2007-2019

summary: The aim of this study was to identify some risk factors of failure of surgical management of common bile duct stones, in our center between 2007 and 2019.


title: Prospective Register on the Etiologies of Cardiogenic Shock and Their Prognosis at One Year.

acronym: cardiac shock

summary: Cardiogenic shock (CC) is one of the major challenges of current cardiology. Despite the difficulty of establishing a strict and consensual definition, it is accepted that the CC clinically corresponds to persistent hypotension (systolic blood pressure 90 mmHg for at least 30 minutes or need for vasopressor support) associated with signs of visceral hypoperfusion (confusion, mottling, oliguria, hyperlactatemia), and hemodynamic with a lowered heart index ( 1.8 L/min/m2) despite appropriate or high filling pressures. This definition of the European Society of Cardiology (ESC) masks however the great variability of hemodynamic tables grouped under the term of CC and severity levels, also variable.However, it was suggested that the etiology of CC influenced both its hemodynamic profile and therefore its therapeutic management but also its prognosis in the medium and long term.

lead_sponsor: Assistance Publique Hopitaux De Marseille

location_facility: Assistance Publique Hopitaux de Marseille


title: Interaction Between Right Heart Dysfunction and Emphysema: Impact of Endoscopic Lung Volume Reduction (RVDD)

acronym: RVDD

summary:
Heart-lung interactions remain misunderstood whereas pulmonary and cardiac pathologies are very commonly associated.

Emphysema by increasing intrathoracic pressure appears to affect cardiac function.

Interestingly, previous studies have shown a link between the telediastolic volume of the right ventricle (measured by RMI) and the intensity of emphysema.

Our hypothesis is that the emphysema by increasing intrathoracic pressure leads to or accentuates right cardiac diastolic dysfunction by decreasing compliance and cardiac preload.

To verify this hypothesis the investigators will perform KT loop procedures in order to acquire intracardiac pressure/volume curves before and after lung volume reduction.

The pressure/volume curves allow the analysis of systolic and diastolic function, cardiac contractility and loading conditions.


title: Early Detection of Mental Disorders in Adolescents With Chronic Pain: Creation of a Screening Tool for Use by the General Practitioner

acronym: REPERADO

summary: This research aims to create a tool for detection of mental health disorders in adolescents with chronic pain. The first part is testing a screening questionnaire and comparing in with existing questionnaires. The second part involves two focus group with the adolescents aimed at recording their perception of the questionnaire.

lead_sponsor: Assistance Publique - Hôpitaux de Paris

location_facility: Centre de la douleur et de la migraine-Hôpital Trousseau


title: Evaluation of Covid-19 Rapid Diagnostic Tests on Blood Drop

acronym: COVID-TEST

summary: This study will evaluate the diagnostic reliability of the Biosynex rapid blood test for Covid-19 infection.

lead_sponsor: CMC Ambroise Paré


title: Evaluation of the Reproducibility of the Measurement of the QSM Signal (Quantitative Susceptibility Mapping)

acronym: ERESI

summary:
Many central nervous system pathologies have an inflammatory component, often associated with an accumulation of disability and more severe tissue damage.

In multiple sclerosis, the inflammatory process is in part characterized by the activation of microglia, an entity of the innate inflammatory system, as well as a breakdown of the blood-brain barrier. During inflammation, activated microglia may contain high levels of iron, characterizing its activated state.

lead_sponsor: Fondation Ophtalmologique Adolphe de Rothschild

location_facility: Hhopital fondation adolphe de rothschild


title: Adaptation and Validation of the Exercise Adherence Rating Scale of Knee Osteoarthritis Patients

acronym: GONEARS

summary:
The origin of knee osteoarthritis is multifactorial but the disease is strongly related to age. The pain and functional disability are the main reasons for consultation. Non-pharmaceutical treatment is always indicated.

The rehabilitation will reduce the pain, maintain or partially recover the amplitude of the movements as well as fight against vicious analgesic attitudes and strengthen the muscles to stabilize the joints. A program of self-rehabilitation exercises performed at home may be prescribed to people with knee osteoarthritis. It must include exercises adapted to the patient's functional abilities and painful level and requires education to improve the patient's motivation to practice a regular exercise program. However, adherence to such exercises is low, and until 2016 there was no objective way to find out the reasons for patients' lack of adherence to self-workout programs. The EARS ("Exercise Adherence Rating Scale" or Adhesion to Physical Exercise Programs) is validated in 2016 and reliable to evaluate the physical activity of patients with low back pain.

As far as we know, this questionnaire is the only one validated in the international literature, a validation for French patients is currently underway. We believe this tool can be used for patients with knee osteoarthritis after minor changes.

lead_sponsor: University Hospital, Clermont-Ferrand


title: Scleral Buckling for Retinal Detachment Prevention in Genetically Confirmed Stickler Syndrome : a Randomized Controlled Trial

acronym: STL-DR-PREV

summary: The purpose of this study is to determine whether a scleral buckling surgical procedure performed on fellow eyes of patients with genetically confirmed Stickler syndrome can prevent the occurrence retinal detachment and/or severe vision loss of the study eye.

ReferenceCitation: Monin C, Van Effenterre G, Andre-Sereys P, Haut J. [Prevention of retinal detachment in Wagner-Stickler disease. Comparative study of different methods. Apropos of 22 cases]. J Fr Ophtalmol. 1994;17(3):167-74. French.

ReferenceCitation: Abeysiri P, Bunce C, da Cruz L. Outcomes of surgery for retinal detachment in patients with Stickler syndrome: a comparison of two sequential 20-year cohorts. Graefes Arch Clin Exp Ophthalmol. 2007 Nov;245(11):1633-8. Epub 2007 Jun 20.

ReferenceCitation: Carroll C, Papaioannou D, Rees A, Kaltenthaler E. The clinical effectiveness and safety of prophylactic retinal interventions to reduce the risk of retinal detachment and subsequent vision loss in adults and children with Stickler syndrome: a systematic review. Health Technol Assess. 2011 Apr;15(16):iii-xiv, 1-62. doi: 10.3310/hta15160. Review.

ReferenceCitation: Ang A, Poulson AV, Goodburn SF, Richards AJ, Scott JD, Snead MP. Retinal detachment and prophylaxis in type 1 Stickler syndrome. Ophthalmology. 2008 Jan;115(1):164-8. Epub 2007 Aug 2.

ReferenceCitation: Fincham GS, Pasea L, Carroll C, McNinch AM, Poulson AV, Richards AJ, Scott JD, Snead MP. Prevention of retinal detachment in Stickler syndrome: the Cambridge prophylactic cryotherapy protocol. Ophthalmology. 2014 Aug;121(8):1588-97. doi: 10.1016/j.ophtha.2014.02.022. Epub 2014 May 1.


title: Assessment of Language Disorders in Multiple Sclerosis Patients

acronym: LANSEP

summary:
Multiple sclerosis (MS) is an autoimmune disease of the central nervous systems that results in focal inflammatory lesions and then diffuse and degenerative inflammatory phenomena. It is considered to be the leading cause of non-traumatic disability in young adults.

Cognitive impairment is a common and disabling part of MS. Studies carried out in the years 1990-2000 estimated their frequency to be between 40 and 60% of MS patients: they reflect the natural history of the disease. Effective treatments for the inflammatory component of the disease that are now available may have led to a reduction in their frequency.

Cognitive disorders were identified at an early stage of the disease and affect certain areas preferentially:

The most common achievement is the reduction in the speed of information processing. It is present from the early stage of the disease. Progressive deterioration over time is observed, which is a prognostic factor for long-term cognitive decline.

Long-term memory was impaired in 40-65% of patients in historical cohorts. More specifically, encoding and retrieval were affected, with storage and consolidation being preserved.

The attainment of executive functions is also common.
Phonemic and semantic fluency are also disturbed in MS patients. Among cognitive impairments, language impairment has been little studied in MS: in 2016 only 22 controlled studies were identified. The assessments carried out were most often partial, making it impossible to define the characteristics or to conclude that specific linguistic impairments are independent of other cognitive impairments. Finally, recent studies suggest that the frequency of language impairment in MS may be underestimated.

Therefore, it seems important to assess the prevalence of language disorders in a large cohort of patients with RRMS or MS, and to characterize these disorders by identifying the linguistic processes involved and the brain substrates involved. This will make it possible to envisage the implementation of more systematic screening for language disorders in MS and to improve patient management, in particular by developing targeted rehabilitation protocols.


title: Unexplained Infertility Treated by Hysteroscopy-laparoscopy : Predictive Factors of Pregnancy

summary: Retrospective study, including patients from january 2013 to december 2018, who were diagnosed with unexplained infertility : spontaneously ovulating women with normal pelvic ultrasound scan, patent tubes on hysterosalpingography and normal pelvic exam or pelvic MRI normal. Semen analyses were normal according to the World Health Organization criteria. Couples were referred for diagnostic laparoscopy and hysteroscopy. They were then addressed for spontaneous fertility or ART to conceive. The investigators would like to see how many surgeries were useful to assess a diagnostic, and if operating allows a satisfying pregnancy rate. The investigators would like to assess how many diagnosis was done after surgery and how many pregnancy were obtained. The investigators search other prognostic factors than age or parity.


title: Development and Validation of an Automated Three-dimensional Cephalometry Method

summary: This study is aimed to develop and assess the validity of an algorithm for automated three-dimensional cephalometry.

location_facility: Service de Chirurgie Maxillo-Faciale, Service de Chirurgie Maxillo-Faciale