title: LIquid Biopsy to prEdict Responses To First-line immunotherapY in Metastatic Non-small Cell LUNG Cancer

acronym: LIBERTYLUNG

summary: Patient with histologically proven NSCLC in a metastatic stage, treatment naïve and eligible for first-line treatment with immune checkpoint inhibitor. Combination with chemotherapy is possible. Presence of a mutation after NGS analysis is required for ctDNA follow-up.

location_facility:
Institut Curie
Hopital Ambroise Pare


title: Mixed-method Study to Evaluate Acceptability, Perceived Toxicity, Preference and Health-related Quality of Life Among HIV Patients Switching to a Dual Therapy Such as the Dovato Regimen

acronym: PROBI

summary:
HIV Treatment simplification strategies that involve switching cART regimens from four or three antiretrovirals to two in virologically suppressed patients living with HIV are now available in order to reduce long-term toxicity and enhance treatment adherence. Dolutegravir is a second-generation integrase strand transfer inhibitor (INSTI) with noticeable advantages, including a high genetic barrier to drug resistance, once-daily dosing and lower risk of drug-drug interactions because this agent does not inhibit or induce cytochrome P450 isoenzymes or P-glycoprotein transporters. Dolutegravir is generally well tolerated and the INSTI class is considered to be more "metabolically friendly" compared with other drug classes such as protease inhibitors (PIs). Thus, the combination of dolutegravir plus a second active agent is a particularly inviting option for maintenance treatment and research in this area is evolving. However, though safety and efficacy of dolutegravir are well known, there is no study evaluating patient-reported outcomes (PROs), i.e. subjective and self-reported measures of the patient's health perception. In an era of the efficacy of HIV regimens are more and more comparable, the main discriminant criteria to choose the best treatment option are now adherence and self-reported measures of a patient's health - termed "patient-reported outcomes" (PROs).

The study, based on a mixed methodology, include a qualitative part and a quantitative part. The qualitative study will explore patients' and health care professionals' perceptions, knowledge, and representations of triple or quadruple and dual therapies and detect the degree of agreement or disagreement between patients' and practitioners' perspectives. The quantitative study's main objective is to measure the Dovato regimen's impact on a patient's perception (Patient-Reported Outcomes - PRO) on acceptability, toxicity, preference, and Health-Related Quality of Life (HRQL). PRO are collected through self-administered questionnaires at D0 (when the patient switch treatment), M1 and M6.

study_start_date_type: Actual

status: Recruiting

study_completion_date_type: Anticipated

study_type: Observational

time_perspective: Prospective

enrollment_type: Anticipated

ipd_sharing: No

lead_sponsor: University Paris 7 - Denis Diderot

location_facility: Centre Hospitalier de Saint-Denis - Hôpital Delafontaine

lead_sponsor_type: academique

status_simplified: Ongoing


title: STRESS From in Charge Relative Facing the Announcement of Decisions Limiting or Stopping Treatments in Emergency Room During the COVID-19 Epidemic

acronym: COVER ACC

summary:
In the context of the COVID-19 pandemic, the emergency reception services had to be radically reorganized. In this tense environment, professionals must face ethical dilemmas, make referral decisions and prioritize patients. Due to the limited number of visits to many hospitals, interactions with relatives and families of patients are mainly conducted by phone. These limitations will continue as long as the context of uncertainty over the course of the pandemic persists. Limitation or discontinuation of treatment (LDT) announcements were therefore also impacted and the exceptional situation related to COVID-19 reinforces the difficulties encountered by professionals in usual time (place of announcement, inappropriate lack of time, etc.). Thus, LDTs are most often done over the phone without the families being able to go to the hospital. Because of this, these announcements can be more traumatic. Investigators have already highlighted in a recent study the lack of communication between caregivers and families in the context of LDT announcements and the context of COVID 19 exacerbated these aspects given the limitations of visits.

The investigators therefore propose to study the experiences of families who are notified of a decision to limit or stop treatment by phone in the emergency room during the COVID-19 crisis.

study_type: Interventional

primary_purpose: Supportive Care

lead_sponsor: Hospices Civils de Lyon

location_facility: Service des urgences, Hôpital Edouard Herriot, Hospices Civils de Lyon

location_facility: service des urgences, Hôpital de la Croix-Rousse, Hospices Civils de Lyon

location_facility: Service d'Accueil des Urgences, Hôpital Lyon Sud, Hospices Civils de Lyon

intervention_type: Other


type: EudraCT Number

title: Study of Total Post-thyroidectomy Hypocalcemia After Preoperative Cholecalciferol Supplementation

acronym: CAVITHY

summary: This prospective study evalue the inflence of pre operative vit D3 administration on post operative hypocalcemia in patients undergoing Total thyroidectomy

design_allocation: Randomized

primary_purpose: Prevention

lead_sponsor: Centre Hospitalier René Dubos

location_facility:
Hospital René Dubos,
Hospital Poissy/Saint-Germain
Hospital Lariboisière, Paris X

intervention_type: Drug


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

acronym: CTC-COL

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

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

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

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

lead_sponsor: University Hospital, Montpellier

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

location_facility: Department of gynaecology, Montpellier University Hospital


type: Other Identifier

title: Study of Ovarian Function and Gynecological Profile of Patients Carrying a Pathogenic Variant of the HNF1B Gene (GYN-HNF1)

summary:
The main objective of this study is to study the ovarian function of patients with hepatocyte nuclear factor-1beta (HNF1B) abnormality, followed in the reference centers of Toulouse and Paris University Hospitals. The secondary objectives are to know the gynecological profile of these patients.

A dosage of anti-mullerian hormone (AMH) will be added to the usual balance, whatever the phase of the cycle and a pelvic ultrasound will be performed by the same operator by center. Patients will be received in a dedicated consultation to complete a questionnaire on gynecological and obstetric history, as well as their personal and family history. There will be no gynecological examination during this consultation.

study_start_date_type: Anticipated

status: Not yet recruiting

primary_purpose: Other

ReferenceType: background

ReferenceCitation: Edghill EL, Bingham C, Ellard S, Hattersley AT. Mutations in hepatocyte nuclear factor-1beta and their related phenotypes. J Med Genet. 2006 Jan;43(1):84-90. Epub 2005 Jun 1.

ReferenceCitation: Lindner TH, Njolstad PR, Horikawa Y, Bostad L, Bell GI, Sovik O. A novel syndrome of diabetes mellitus, renal dysfunction and genital malformation associated with a partial deletion of the pseudo-POU domain of hepatocyte nuclear factor-1beta. Hum Mol Genet. 1999 Oct;8(11):2001-8.

ReferenceCitation: Oram RA, Edghill EL, Blackman J, Taylor MJ, Kay T, Flanagan SE, Ismail-Pratt I, Creighton SM, Ellard S, Hattersley AT, Bingham C. Mutations in the hepatocyte nuclear factor-1β (HNF1B) gene are common with combined uterine and renal malformations but are not found with isolated uterine malformations. Am J Obstet Gynecol. 2010 Oct;203(4):364.e1-5. doi: 10.1016/j.ajog.2010.05.022. Epub 2010 Jul 15.

lead_sponsor: University Hospital, Toulouse

location_facility:
Necker Hospital
Toulouse University Hospital
Pitié Salpêtrière Hospital -

intervention_type: Biological


title: Validity of a Task of Acoustic-phonetic Decoding on Anatomic Deficits in Paramedical Assessment of Speech Disorders for Patients Treated for Oral or Oropharyngeal Cancer

acronym: DAPADAF-E

summary:
The bridging of the gap between speech production and perception by the interlocutor would be made possible by the use of a more suitable and automatic task. An acoustic-phonetic decoding test (or DAP in French, i.e. the production of isolated pseudo-words in repetition or reading), created within the framework of the InCA C2SI project, avoids the effects of cognitive restoration by the interlocutor. An automatic score from the DAP would lead to an overall score per patient, but also to scores specific to each phonetic segment, to be correlated with the analytical scores from each anatomical oropharyngeal segment.

The study hypothesis is that the automatic processing of an acoustic-phonetic decoding task during the assessment in current practice is a valid and reliable tool for diagnosing oropharyngeal analytical and dynamic deficits by highlighting deficient linguistic units.

The study hypothesis is that the automatic processing of an acoustico-phonetic decoding task during the assessment in current practice is a tool for diagnosing oropharyngeal analytical and dynamic deficits by highlighting deficient linguistic units.

ReferenceCitation: Balaguer M, Farinas J, Fichaux-Bourin P, Puech M, Pinquier J, Woisard V. Validation of the French Versions of the Speech Handicap Index and the Phonation Handicap Index in Patients Treated for Cancer of the Oral Cavity or Oropharynx. Folia Phoniatr Logop. 2020;72(6):464-477. doi: 10.1159/000503448. Epub 2019 Nov 15.

ReferenceCitation: Balaguer M, Champenois M, Farinas J, Pinquier J, Woisard V. The (head and neck) carcinologic handicap index: validation of a modular type questionnaire and its ability to prioritise patients' needs. Eur Arch Otorhinolaryngol. 2021 Apr;278(4):1159-1169. doi: 10.1007/s00405-020-06201-6. Epub 2020 Jul 14.

ReferenceCitation: Lalain M, Ghio A, Giusti L, Robert D, Fredouille C, Woisard V. Design and Development of a Speech Intelligibility Test Based on Pseudowords in French: Why and How? J Speech Lang Hear Res. 2020 Jul 20;63(7):2070-2083. doi: 10.1044/2020_JSLHR-19-00088. Epub 2020 Jun 29.

location_facility: Institut universitaire du Cancer de Toulouse - Oncopole

location_facility: AP- H Marseille - Hôpital de la Conception


title: Low Impact Laparoscopic in Colorectal Resection: a Randomized Trial Comparing Low Pneumoperitoneum Pressure Plus Microsurgery Versus Low Pneumoperitoneum Alone

summary: To improve post-operative recovery, the concept of Low Impact Laparoscopy was developed in colo-rectal surgery with associating low-pressure pneumoperitoneum and microlaparoscopic surgery. A phase III double-blind, prospective, randomized, controlled, multi-centric trial is designed in the aim to assess the impact of low-pressure pneumoperitoneum with microlaparoscopic instruments on post-operative pain at 24 hours without taking opioids. It is compared with low-pressure laparoscopy with classical laparoscopic instruments in patients undergoing colorectal surgeries.

primary_purpose: Treatment

lead_sponsor: University Hospital, Bordeaux

location_facility:
CH de la Côte Basque
CHU Bordeaux
Ch Libourne

intervention_type: Procedure


title: Dose Escalation, First-in-human Clinical Trial to Evaluate the Safety, Pharmacokinetics and Preliminary Antitumor Activity of PEP-010, Administered as Single Agent and in Combination With Paclitaxel in Patients With Metastatic Solid Cancer

summary:
This is an open-label, non-controlled, multicenter, dose escalation, first-in-human phase I clinical trial with an expansion phase designed to assess the safety, tolerability, PK and PD parameters, and preliminary antitumor activity of intravenous dosing of PEP-010 as single agent and in combination with paclitaxel.

PEP-010 will be administered as single agent in patients with solid cancers who are not amenable to standard treatment, or in combination in patients who are eligible for the paclitaxel therapy.

design_allocation: Non-Randomized

ReferenceCitation: 1.Ezzalfani M. et al. The role of the expansion cohort in phase I trials in oncology: guidelines of the phase I HUB. Bull Cancer. 2015 Jan;102(1):73-82. doi:10.1016/j.bulcan. 2014.10.001. Epub 2015 Jan 2. Review. French. 2.M3(R2) guideline : Nonclinical Safety Studies for the Conduct of Human Clinical Trials and Marketing Authorization for Pharmaceuticals 3.ICH S9 - Nonclinical Evaluation for Anticancer Pharmaceuticals EMEA/CHMP/ICH/646107/2008 4.Masini et al. Histamin-releasing properties of polysorbate 80 in vitro and in vivo: correlation 1254 with its hypotensive action in the dog. Agents Actions 1985 Sep; 16(6):470-7. 5.Guideline on repeated dose toxicity - CPMP/SWP/1042/99 Rev 1 6.Storer B.E. Design and Analysis of Phase I Clinical Trials. Biometrics, Vol. 45, No. 3 (Sep., 1989), pp. 925-937. 7.Seshan V.E. et al. Clinical Trial Design and Data Analysis Functions, Package clinfun, version 1.0.15 (Apr 2018)

lead_sponsor: Institut Curie

location_facility:
CLCC F.Baclesse Caen
Institut Curie
Gustave Roussy

intervention_type: Combination Product


title: LEVOSIMENDAN to Facilitate Weaning From ECMO in Severe Cardiogenic Shock Patients

acronym: LEVOECMO

summary:
In the last decade, venoarterial extracorporeal membrane oxygenation (VA-ECMO) has become the first-line therapy in patients with refractory cardiogenic shock. VA-ECMO provides both respiratory and cardiac support, is easy to insert, even at the bedside, provides stable flow rates, and is associated with less organ failure after implantation compared to large biventricular assist-devices that require open-heart surgery. In patients with potentially reversible cardiac failure (e.g. myocarditis, myocardial stunning post-myocardial infarction, post-cardiotomy or post-cardiac arrest), VA-ECMO might be weaned after a few days of support and used as a bridge to recovery.

Although considered as the ultimate life-saving technology for refractory cardiac failure, veno-arterial ECMO is still associated with severe complications. Specifically, excessive LV afterload and lack of LV unloading under VA-ECMO might induce LV stasis with thrombus formation, pulmonary edema, myocardial ischemia caused by ventricular distension and ultimately increase mortality. ECMO support also exposes to many complications such as infections, hemorrhage or peripheral vascular embolism. These complications are more frequent with prolonged support and are responsible for significant morbidity and mortality, prolonged ICU and hospital stays and higher costs.

Levosimendan, which acts to sensitize myocardial contractile proteins to calcium, improves cardiac contractility without increasing the intracellular calcium concentration. Unlike traditional inotropes such as dobutamine, levosimendan neither increases myocardial oxygen consumption nor impairs diastolic function or possess proarrhythmic effects. It also influences the opening of ATP-dependent potassium channels, including those in vascular smooth muscle cells, leading to coronary, pulmonary, and peripheral vasodilation and antiinflammatory, antioxidative, antiapoptotic, anti-stunning and cardioprotective effects. Additionally, Levosimendan which has a long lasting action (up to 7-9 d), resulting from the formation of active metabolite, may be used as a single 24h perfusion.

In recent preliminary studies, the drug was associated with accelerated weaning from VA-ECMO and even improved survival. Therefore, a multicenter randomized trial with sufficient statistical power is needed in refractory cardiogenic shock patients supported by VA-ECMO to test if the early administration of Levosimendan can facilitate and accelerate VA-ECMO weaning, and ultimately translate in significantly less morbidity, reduced ICU and hospital length of stays and associated costs.

lead_sponsor: Assistance Publique - Hôpitaux de Paris

location_facility:
Hôpital Pitié Salpêtrière
Hôpital du Haut-Lévêque
Hôpital Européen Georges Pompidou


title: Effectiveness of CERvico-isthmic CErclage in Increasing the Rate of Live Births in Case of a History of Late Miscarriage and/or Premature Delivery

acronym: CERCEI LB

summary: This study compares the rate of live births before and after cervico-isthmic cerclage in 3 hospitals in the last 10 years. The hypothesis is that cerclage significantly increases the rate of live births in women with cervical insufficiency.

status: Completed

study_completion_date_type: Actual

time_perspective: Retrospective

enrollment_type: Actual

location_facility: Centre Hospitalier Lyon Sud (CHLS) - Hospices Civils de Lyon

location_facility: Hôpital Femme Mère Enfant (HFME) - Hospices Civils de Lyon

location_facility: Hôpital de la Croix Rousse - Hospices Civils de Lyon

status_simplified: Completed


title: Identification of New Markers of Atrial Myopathy in Patients With Embolic Stroke of Undetermined Source (ESUS) From MRI 4D Data

acronym: IRM 4D-AVC

summary: Atrial myopathy is considered to be the underlying cause of a large proportion of embolic strokes of undetermined source. However, the definition of this atrial condition is not well delineated while its identification could lead to prescription on anticoagulation in order to avoid stroke recurences. This study aims to identify new markers of atrial myopathy and choosed a multi parametric approach with electrical, echographical, biological and 4D flow CMR derived markers.

primary_purpose: Basic Science

location_facility: Service d'urgences neuro-vasculaires, service de neurologie vasculaire Hôpital neurologique Pierre Wertheimer

location_facility: Service Imagerie médicale Hôpital neurologique Pierre Wertheimer

location_facility: Service rythmologie, Hôpital cardiologique Louis Pradel


title: Combining Epigenetic And Immune Therapy to Beat Cancer. CAIRE Study

acronym: CAIRE

summary: Umbrella study structure to independently and simultaneously assess the effects of the association of durvalumab and tazemetostat in multiple solid tumors.

lead_sponsor: Institut Bergonié

location_facility:
CHU Poitiers
Institut Bergonie
CHRU Brest

lead_sponsor_type: industriel


title: Impact of the Double Haploinsufficiency of the RBM22 and SLU7 Genes in Del(5q) Myelodysplastic Syndromes Isolated or Not Compared to the Single Haploinsufficiency of RBM22 and Normal Karyotype Myelodysplastic Syndromes.

summary: Myelodysplastic syndromes (MDS) are malignant hematopathies of the elderly characterized by persistent cytopenias and the presence of deregulated clonal hematopoiesis. The risk of progression to acute myeloid leukemia (AML) is variable. Acquired cytogenetic abnormalities are found in less than 50% of de novo cases and up to 80% in secondary MDS. The deletion of the long arm of chromosome 5 (written del(5q)) is the most common abnormality in MDS (15%). Del(5q) MDS has a good prognosis, with a median survival of 6 years and a 15% risk of progression to AML. However, their life expectancy is shorter than the general population, and the quality of life of patients is diminished. These treatments are not that effective over a long period of time or not well tolerated, and the majority of patients die from causes related to their MDS, such as infections (38%), progression to AML (15%), or bleeding (13%). Two genes, RBM22 and SLU7, coding for proteins of the same complex involved in splicing pre-messenger RNA are carried on the long arm of chromosome 5. We investigate the pronostic impact and the predictive value of the double haploinsufficiency of the RBM22 and SLU7 genes in del(5q) myelodysplastic syndromes isolated or not compared to the single haploinsufficiency of RBM22 and normal karyotype myelodysplastic syndromes.

ipd_sharing: Yes

ipd_sharing_description: All collected data that underlie results in a publication

lead_sponsor: University Hospital, Brest

location_facility: Groupe Français de cytogénétique Hématologique

intervention_type: Genetic


type: Registry Identifier

title: Lumbar Belt Benefit Compared to the Usual Care in the Treatment of Non-specific Low Back Pain -an Interventional, Prospective, Multicenter, Randomized, Open and Controlled Study

acronym: LOMBACT

summary: Lumbar belt benefit compared to the usual care in the treatment of non-specific low back pain -an interventional, prospective, multicenter, randomized, open and controlled.study

lead_sponsor: Thuasne

location_facility:
CHU Grenoble Alpes
CHU de St Etienne
Hôpital Cochin

intervention_type: Device


title: Evaluation of the Hemodynamic Effects of Transvenous Phrenic Stimulation

acronym: HEMOSTIM

summary:
Mechanical ventilation is a cornerstone in the management of severe forms of pneumonia, acute respiratory distress syndrome. It provides essential oxygen to patients, ventilates the lungs but also has deleterious effects like any treatment, in particular by reducing cardiac output by reducing venous return. Mechanical ventilation also has effects on the diaphragm: diaphragmatic dysfunction. It is explained by a prolonged inactivity of this muscle with a reduction of muscle fibers that can settle down quickly, after only a few days of mechanical ventilation. This dysfunction results in a reduction in the latter's ability to generate intrathoracic pressure necessary for ventilation, slows the withdrawal of mechanical ventilation and lengthens the duration of stay in intensive care unit. To reduce this dysfunction, phrenic stimulation has been proposed as an alternative to remuscler the diaphragm thanks to electrodes located on a central venous catheter, also used to deliver the usual therapies in intensive care unit.

The HEMOSTIM study is interested in the effects of phrenic stimulation on regional ventilation, cardiac output and cerebral perfusion: investigator hypothesize that diaphragmatic stimulation allows an improvement of these parameters.

primary_purpose: Diagnostic

lead_sponsor: University Hospital, Angers

location_facility:
CHU Angers
APHP La Pitié-Salpêtrière


title: Autotaxin in Patients With GNAS/PTH Abnormalities

acronym: GNAS-AUTAX

summary:
PTH secretion defects (grouped under the name hypoparathyroidism) are due to abnormalities in the PTH gene, abnormalities in the development of the parathyroid glands which synthesize PTH or abnormalities of the calcium sening receptor whose role is to adapt PTH level to ambient calcium level.

In contrast, primary hyperparathyroidism in children is also exceptional; expressed by hypercalcemia, with a renal and bon risk.

Pseudo-hypoparathyroidism, now known under the term inactivating PTH / PTHrP Signaling Disorder or iPPSD, are rare pathologies characterized by resistance to the action of PTH sometimes associated with other symptoms, in particular chondrodysplasia. They are linked to a defect in the action of a factor in the signaling pathway of G protein-coupled receptors that activate the production of cyclic AMP (cAMP). IPPSDs are most often due to a molecular defect in the GNAS gene, subject to parental imprint.

Fibrous dysplasia / McCune-Albright syndrome is a rare disease caused by somatic "gain-of-function" mutations in the GNAS gene located on chromosome 20q13 leading to activation of the protein Gαs and inappropriate production of intracellular cyclic adenosine monophosphate (cAMP). The clinical phenotype is determined by the location and extent of the tissues affected by this mutation.

Autotaxin (ATX) is a protein secreted by different tissues including the liver, fatty tissue, and bone. Today, ATX is described as the major source of LPA in the bloodstream. LPA interacts with one of its receptors on the surface of the cell membrane. Depending on the receptor engaged, one or more Gα subunits (G12 / 13, GQ, Gi / o or Gs) will activate multiple cell signaling pathways.

In bone, ATX is expressed by osteoclasts and osteoblasts. Recent laboratory data have shown that PTH stimulates ATX expression in osteoblasts in a dose-dependent manner.

The objective of this study is to provide clinical proof of concept that the PTH / Gαs / ATX pathway is truly significant in physiology and pathology, by studying the full spectrum of PTH and GNAS pathologies. If this proof of concept is obtained, therapeutic applications will probably be possible in the long term.

ipd_sharing: Undecided

location_facility: Centre de compétence des maladies rares de l'insulino-sécrétion et de l'insulino-sensibilité

location_facility: Centre de Référence des Maladies Rares du Métabolisme du Calcium et du Phosphate Service d'Endocrinologie et Diabète de l'Enfant Hôpital Bicêtre Paris Saclay

location_facility: Centre de référence Dysplasie Fibreuse des os Service rhumatologie et pathologie osseuse Hôpital Edouard Herriot, Lyon


title: The Degen Study: Post-market Clinical Follow-up on the PASS LP, PASS Degen and PASS Tulip Systems.

acronym: PASS DEGEN

summary: The purpose of this post-market clinical study is to evaluate the long-term safety and efficacy of the MEDICREA's systems PASS LP, PASS DEGEN, and PASS Tulip PRIME to treat degenerative diseases. This study is supporting the clinical evaluation report. From the standard-of-care perspective, the results of The Degen study are expected to contribute to a better understanding of expected safety and clinical outcomes from a short (intra- and peri-operative) to a medium-term follow-up (post-operatively).

status: Active, not recruiting

time_perspective: Other

ReferenceCitation: Copay AG, Glassman SD, Subach BR, Berven S, Schuler TC, Carreon LY. Minimum clinically important difference in lumbar spine surgery patients: a choice of methods using the Oswestry Disability Index, Medical Outcomes Study questionnaire Short Form 36, and pain scales. Spine J. 2008 Nov-Dec;8(6):968-74. doi: 10.1016/j.spinee.2007.11.006. Epub 2008 Jan 16.

ReferenceCitation: Hägg O, Fritzell P, Nordwall A; Swedish Lumbar Spine Study Group. The clinical importance of changes in outcome scores after treatment for chronic low back pain. Eur Spine J. 2003 Feb;12(1):12-20. Epub 2002 Oct 24.

ReferenceCitation: Glassman SD, Carreon LY, Djurasovic M, Dimar JR, Johnson JR, Puno RM, Campbell MJ. Lumbar fusion outcomes stratified by specific diagnostic indication. Spine J. 2009 Jan-Feb;9(1):13-21. doi: 10.1016/j.spinee.2008.08.011. Epub 2008 Sep 19.

ReferenceCitation: Fairbank JC. Why are there different versions of the Oswestry Disability Index? J Neurosurg Spine. 2014 Jan;20(1):83-6. doi: 10.3171/2013.9.SPINE13344. Epub 2013 Nov 8. Review.

ReferenceCitation: Fairbank JC, Pynsent PB. The Oswestry Disability Index. Spine (Phila Pa 1976). 2000 Nov 15;25(22):2940-52; discussion 2952. Review.

ReferenceCitation: Johnsen LG, Hellum C, Nygaard OP, Storheim K, Brox JI, Rossvoll I, Leivseth G, Grotle M. Comparison of the SF6D, the EQ5D, and the oswestry disability index in patients with chronic low back pain and degenerative disc disease. BMC Musculoskelet Disord. 2013 Apr 26;14:148. doi: 10.1186/1471-2474-14-148.

ReferenceCitation: Gum JL, Carreon LY, Stimac JD, Glassman SD. Predictors of Oswestry Disability Index worsening after lumbar fusion. Orthopedics. 2013 Apr;36(4):e478-83. doi: 10.3928/01477447-20130327-26.

ReferenceCitation: Ghogawala Z, Whitmore RG, Watters WC 3rd, Sharan A, Mummaneni PV, Dailey AT, Choudhri TF, Eck JC, Groff MW, Wang JC, Resnick DK, Dhall SS, Kaiser MG. Guideline update for the performance of fusion procedures for degenerative disease of the lumbar spine. Part 3: assessment of economic outcome. J Neurosurg Spine. 2014 Jul;21(1):14-22. doi: 10.3171/2014.4.SPINE14259. Review.

ReferenceCitation: Gandek B, Ware JE, Aaronson NK, Apolone G, Bjorner JB, Brazier JE, Bullinger M, Kaasa S, Leplege A, Prieto L, Sullivan M. Cross-validation of item selection and scoring for the SF-12 Health Survey in nine countries: results from the IQOLA Project. International Quality of Life Assessment. J Clin Epidemiol. 1998 Nov;51(11):1171-8.

lead_sponsor: Medicrea International

location_facility:
Clinique du Dos Bordeaux - Terrefort
Clinique des Cèdres
CHRU Tours, Hôpital de Bretonneau


title: Effect of Irradiation Doses < 10 Gy and of Irradiated Bone Volume on the Variation of Blood Elements of the Complete Blood Count During and After Pelvic Irradiation

acronym: MIFADORESOL

summary: Bone marrow is one of the organs at risk of complications during irradiation due to its radiosensitivity. Hematopoietic toxicity remains one of the main toxicities during irradiation of pelvic lymph node areas, especially when concomitant chemotherapy is used, volume of bone marrow irradiated is large and dose to the bone marrow is high. There is a lack of prospective studies and comparative trials to customize the constraints according to the presence or absence of chemotherapy and correlated to the patient's bone marrow potential. This multicentric and prospective study conducted by Strasbourg Europe Cancerology Institute aims to evaluate hematological toxicity (anemia, thrombocytopenia, leukopenia) in patients treated with pelvic irradiation for prostate, rectum, anal canal, endometrium, cervix cancer or vaginal cancer. One hundred patients will be included in the study, including patients treated with exclusive radiotherapy, radiochemotherapy, or radiohormonal therapy. The primary objective is to quantify the relationship between acute hematological toxicity and delivered doses and irradiated volumes in pelvic bone marrow for pelvic cancers. Hematological toxicity will be measured by weekly blood count during radiotherapy and at one month and three months after the end of radiotherapy. Secondary endpoints are the evaluation of viral, bacterial and fungal infections during and for three months following radiotherapy, as well as the evaluation of the impact of radiation-induced hematological toxicity on the administration of chemotherapy for the concerned patients. The aim of this study is to improve and optimize radiotherapy if a dose limit or volume constraint is imposed by the results of the study.

lead_sponsor: Institut de cancérologie Strasbourg Europe

location_facility: Institut de Cancerologie Strasbourg Europe


title: Exploratory Study to Evaluate the Clinical Benefits of Wearing the Panty MOBIDERM in Patients With Pelvic and/or Genital Lymphedema : OLYMPY Study

acronym: OLYMPY

summary: Lymphedema (LO) is a chronic and disabling condition that affects quality of life. This pathology has a physical, psychological, social and professional impact. Pelvic or genital lymphedema (LP/LG) is the result of a dysfunction of the lymphatic system in the genital area that can occur following surgery, radiation therapy, tumor, infections affecting the inguinal lymph nodes or related lymphatic pathways (secondary LP/LG). Urogenital cancers are the major cause of secondary LP/LG. It is difficult to have an accurate estimate of the prevalence of LP/LG. LP/LG can be painful, the edema very bulky and disharmonious. The patient is facing with significant physical and psychological difficulties. The volume of the lymphedema can be important, causing discomfort, rubbing when walking or during physical activities, disrupting daily life and may constitute a major handicap.

ReferenceCitation: Garaffa G, Christopher N, Ralph DJ. The management of genital lymphoedema. BJU Int. 2008 Aug;102(4):480-4. doi: 10.1111/j.1464-410X.2008.07559.x. Epub 2008 Mar 5.

ReferenceCitation: Facio MF, Spessoto LC, Gatti M, Ferraz Arruda PF, Ferraz Arruda JG, Antoniassi TS, Bogdan AP, Godoy MF, Godoy JM, Facio FN Jr. Clinical Treatment of Penile Fibrosis After Penoscrotal Lymphedema. Urol Case Rep. 2017 Jan 5;11:14-16. doi: 10.1016/j.eucr.2016.12.001. eCollection 2017 Feb.

ReferenceCitation: Shim TN, Doiron PR, Francis N, Minhas S, Muneer A, Hawkins D, Dinneen M, Bunker CB. Penile lymphoedema: approach to investigation and management. Clin Exp Dermatol. 2019 Jan;44(1):20-31. doi: 10.1111/ced.13609. Epub 2018 Jul 15.

location_facility: CHU TOULOUSE - service médecine vasculaire

location_facility: CHU Montpellier - Hôpital St Eloi - Service Maladies Vasculaires

location_facility: Hôpital Cognacq-Jay - unité de lymphologie


title: Study of Risk Factors for the Occurrence and Severity of Exertional Heatstroke in the Military Environment

acronym: EXPLO-CCE

summary:
Although the circumstances of onset and management of exertional heatstroke have been identified for several years, its pathophysiology remains imperfectly understood. Exertional heatstroke is the result of both extrinsic (i.e. environmental) and intrinsic (i.e. individual) contributing factors.

Extrinsic factors are well known (high ambient temperature and hygrometry, poorly "breathable" clothing, intense and prolonged physical effort) but some of them may be observed in milder conditions. In the French Armed Forces, 25% of the exertional heatstrokes that have been reported between 2005 and 2011 occurred below 17°C.

Intrinsic factors, on the other hand, are numerous and less consensual, partly because of the imperfect knowledge of exertional heatstroke physiopathology. Potential factors include a thermoregulatory defect (inability to maintain a temperature plateau during an effort) and several genetic mutations may also contribute to explain a propensity to present an exertional heatstroke. While exertional heatstroke is clearly not a monogenic pathology, the association of several polymorphisms could contribute to this vulnerability. Among the genes that have been explored, mutations in ryanodine receptor type 1 (RyR 1), calsequestrin-1 or angiotensin-1 converting enzyme (ACE) appear to be potential candidates. However, it is very likely that other polymorphisms may be involved, such as: genes involved in sports performance and exercise rhabdomyolysis, in the inflammatory cascade, permeability of the digestive epithelial barrier, adenosine receptors and susceptibility to anxiety.

Finally, motivation is a mixed factor often claimed to be involved in exertional heatstroke but has never been quantified and needs to be objectified.

To date, none of these hypotheses has been clearly assessed by comparing patients who experienced exertional heatstroke to healthy subjects.

lead_sponsor: Direction Centrale du Service de Santé des Armées

location_facility: Hôpital d'Instruction des Armées Laveran

location_facility: Institut de Recherche Biomédicale des Armées


title: Predictive Value of Diaphragmatic Excursion by Echographic Assessment at the Bedside on Need for Endotracheal Intubation in COPD Patients With Acute Dyspnea in Emergency Medicine

acronym: PREEDICT-ED

summary:
The investigators seek to evaluate if the ultra-sound measure of the diaphragm expansion is predictive of admission into an ICU and/or intubation for patients with COPD.

Every patient coming to the ER with shortness of breath and a known or suspected COPD, will undergo standard of care associated with a diaphragm ultrasound.

The investigators will then gather, through the internal databases of the recruiting hospitals, information about admission into ICU and/or intubation.

The investigators think that this technique will help improve early detection of COPD patient requiring mechanical ventilation, using ultrasound, a non invasive technique.

status: Unknown status

ReferenceCitation: Osadnik CR, Tee VS, Carson-Chahhoud KV, Picot J, Wedzicha JA, Smith BJ. Non-invasive ventilation for the management of acute hypercapnic respiratory failure due to exacerbation of chronic obstructive pulmonary disease. Cochrane Database Syst Rev. 2017 Jul 13;7:CD004104. doi: 10.1002/14651858.CD004104.pub4. Review.

ReferenceCitation: Guttikonda SNR, Vadapalli K. Approach to undifferentiated dyspnea in emergency department: aids in rapid clinical decision-making. Int J Emerg Med. 2018 Apr 4;11(1):21. doi: 10.1186/s12245-018-0181-z.

ReferenceCitation: Palkar A, Narasimhan M, Greenberg H, Singh K, Koenig S, Mayo P, Gottesman E. Diaphragm Excursion-Time Index: A New Parameter Using Ultrasonography to Predict Extubation Outcome. Chest. 2018 May;153(5):1213-1220. doi: 10.1016/j.chest.2018.01.007. Epub 2018 Jan 17.

ReferenceCitation: Bobbia X, Clément A, Claret PG, Bastide S, Alonso S, Wagner P, Tison T, Muller L, de La Coussaye JE. Diaphragmatic excursion measurement in emergency patients with acute dyspnea: toward a new diagnostic tool? Am J Emerg Med. 2016 Aug;34(8):1653-7. doi: 10.1016/j.ajem.2016.05.055. Epub 2016 May 24.

ReferenceCitation: Boussuges A, Gole Y, Blanc P. Diaphragmatic motion studied by m-mode ultrasonography: methods, reproducibility, and normal values. Chest. 2009 Feb;135(2):391-400. doi: 10.1378/chest.08-1541. Epub 2008 Nov 18.

ReferenceCitation: Marchioni A, Castaniere I, Tonelli R, Fantini R, Fontana M, Tabbì L, Viani A, Giaroni F, Ruggieri V, Cerri S, Clini E. Ultrasound-assessed diaphragmatic impairment is a predictor of outcomes in patients with acute exacerbation of chronic obstructive pulmonary disease undergoing noninvasive ventilation. Crit Care. 2018 Apr 27;22(1):109. doi: 10.1186/s13054-018-2033-x.

ReferenceCitation: Zanobetti M, Scorpiniti M, Gigli C, Nazerian P, Vanni S, Innocenti F, Stefanone VT, Savinelli C, Coppa A, Bigiarini S, Caldi F, Tassinari I, Conti A, Grifoni S, Pini R. Point-of-Care Ultrasonography for Evaluation of Acute Dyspnea in the ED. Chest. 2017 Jun;151(6):1295-1301. doi: 10.1016/j.chest.2017.02.003. Epub 2017 Feb 16.

ReferenceCitation: Malas O, Cağlayan B, Fidan A, Ocal Z, Ozdoğan S, Torun E. Cardiac or pulmonary dyspnea in patients admitted to the emergency department. Respir Med. 2003 Dec;97(12):1277-81.

ReferenceCitation: Mueller C, Scholer A, Laule-Kilian K, Martina B, Schindler C, Buser P, Pfisterer M, Perruchoud AP. Use of B-type natriuretic peptide in the evaluation and management of acute dyspnea. N Engl J Med. 2004 Feb 12;350(7):647-54.

ReferenceCitation: Vestbo J, Hurd SS, Agustí AG, Jones PW, Vogelmeier C, Anzueto A, Barnes PJ, Fabbri LM, Martinez FJ, Nishimura M, Stockley RA, Sin DD, Rodriguez-Roisin R. Global strategy for the diagnosis, management, and prevention of chronic obstructive pulmonary disease: GOLD executive summary. Am J Respir Crit Care Med. 2013 Feb 15;187(4):347-65. doi: 10.1164/rccm.201204-0596PP. Epub 2012 Aug 9. Review.

ReferenceCitation: Rodriguez-Roisin R. Toward a consensus definition for COPD exacerbations. Chest. 2000 May;117(5 Suppl 2):398S-401S. Review.

ReferenceCitation: Brochard L, Mancebo J, Wysocki M, Lofaso F, Conti G, Rauss A, Simonneau G, Benito S, Gasparetto A, Lemaire F, et al. Noninvasive ventilation for acute exacerbations of chronic obstructive pulmonary disease. N Engl J Med. 1995 Sep 28;333(13):817-22.

ReferenceCitation: Bobbia X, Hansel N, Muller L, Claret PG, Moreau A, Genre Grandpierre R, Chenaitia H, Lefrant JY, de La Coussaye JE. Availability and practice of bedside ultrasonography in emergency rooms and prehospital setting: a French survey. Ann Fr Anesth Reanim. 2014 Mar;33(3):e29-33. doi: 10.1016/j.annfar.2013.12.010. Epub 2014 Jan 20.

ReferenceCitation: Antenora F, Fantini R, Iattoni A, Castaniere I, Sdanganelli A, Livrieri F, Tonelli R, Zona S, Monelli M, Clini EM, Marchioni A. Prevalence and outcomes of diaphragmatic dysfunction assessed by ultrasound technology during acute exacerbation of COPD: A pilot study. Respirology. 2017 Feb;22(2):338-344. doi: 10.1111/resp.12916. Epub 2016 Oct 14.

ReferenceCitation: De Troyer A, Wilson TA. Effect of acute inflation on the mechanics of the inspiratory muscles. J Appl Physiol (1985). 2009 Jul;107(1):315-23. doi: 10.1152/japplphysiol.91472.2008. Epub 2009 Mar 5. Review.

ReferenceCitation: Gayan-Ramirez G, Decramer M. Mechanisms of striated muscle dysfunction during acute exacerbations of COPD. J Appl Physiol (1985). 2013 May;114(9):1291-9. doi: 10.1152/japplphysiol.00847.2012. Epub 2013 Jan 31. Review.

ReferenceCitation: Unal O, Arslan H, Uzun K, Ozbay B, Sakarya ME. Evaluation of diaphragmatic movement with MR fluoroscopy in chronic obstructive pulmonary disease. Clin Imaging. 2000 Nov-Dec;24(6):347-50.

ReferenceCitation: Doucet M, Debigaré R, Joanisse DR, Côté C, Leblanc P, Grégoire J, Deslauriers J, Vaillancourt R, Maltais F. Adaptation of the diaphragm and the vastus lateralis in mild-to-moderate COPD. Eur Respir J. 2004 Dec;24(6):971-9.

ReferenceCitation: Demoule A, Girou E, Richard JC, Taille S, Brochard L. Benefits and risks of success or failure of noninvasive ventilation. Intensive Care Med. 2006 Nov;32(11):1756-65. Epub 2006 Sep 21.

ReferenceCitation: Levine S, Nguyen T, Kaiser LR, Rubinstein NA, Maislin G, Gregory C, Rome LC, Dudley GA, Sieck GC, Shrager JB. Human diaphragm remodeling associated with chronic obstructive pulmonary disease: clinical implications. Am J Respir Crit Care Med. 2003 Sep 15;168(6):706-13. Epub 2003 Jul 11.

ReferenceCitation: Levine S, Kaiser L, Leferovich J, Tikunov B. Cellular adaptations in the diaphragm in chronic obstructive pulmonary disease. N Engl J Med. 1997 Dec 18;337(25):1799-806.

ReferenceCitation: Sinderby C, Spahija J, Beck J, Kaminski D, Yan S, Comtois N, Sliwinski P. Diaphragm activation during exercise in chronic obstructive pulmonary disease. Am J Respir Crit Care Med. 2001 Jun;163(7):1637-41.

ReferenceCitation: Hughes PD, Polkey MI, Harrus ML, Coats AJ, Moxham J, Green M. Diaphragm strength in chronic heart failure. Am J Respir Crit Care Med. 1999 Aug;160(2):529-34.

ReferenceCitation: Watson RA, Pride NB. Postural changes in lung volumes and respiratory resistance in subjects with obesity. J Appl Physiol (1985). 2005 Feb;98(2):512-7. Epub 2004 Oct 8.

ReferenceCitation: McCool FD, Tzelepis GE. Dysfunction of the diaphragm. N Engl J Med. 2012 Mar 8;366(10):932-42. doi: 10.1056/NEJMra1007236. Review. Erratum in: N Engl J Med. 2012 May 31;366(22):2138.

lead_sponsor: European Georges Pompidou Hospital

location_facility:
Nîmes University Hospital
Bellepierre Hospital
Georges Pompidou European Hospital

status_simplified: Unknown


title: Evaluation of the Performance and Safety of the Atoldys/ Lexilens Glasses Developed to Improve the Reading of Dyslexic Subjects

summary: The aim of this study is to evaluate the efficacy and safety of a new medical device (Atoldys/ Lexilens glasses) on the improvement of reading skills of young dyslexic subjects.

lead_sponsor: ABEYE

location_facility:
Dr Laurence Derieux
CHU Rennes
Dr Luc-Marie Virlet


title: Evolution of Succinate Accumulation Detected in Vivo by Spectroscopic Magnetic Resonance Imaging (1H-SRM) After External Beam Radiation Therapy in SDHx-mutated Patients With Cervical Paragangliomas

acronym: RADIOSUCCES

summary: Qualitative and quantitative biomarker of response to radiotherapy is needed in paragangliomas. We aim at assessing the added value of 1H-SRM for the evaluation of early response to EBR therapy in patients with cervical SDHx PGL.

ipd_sharing_description: Individual participant data (IPD) that underlie results in publication could be shared.

location_facility:
Hopital européen Georges Pompidou
Hôpital Lariboisière
Hôpital Pitié-Salpêtrière

intervention_type: Diagnostic Test


title: Regorafenib in Combination With Metronomic Cyclophosphamide, Capecitabine, and Low-dose Aspirin in Metastatic Colorectal Cancer Carcinoma An Open-label Phase II

summary: The investigators propose a phase II clinical trial with the objective to investigate the potential clinical interest to associate regorafenib with a metronomic chemotherapy combining capecitabine, cyclophosphamide and low-dose aspirin, for the treatment of patients with metastatic colorectal cancer. The main objective of the study will be to achieve 15% of objective response rate in patients treated with multimodal metronomic chemotherapy and regorafenib.

lead_sponsor: Centre Hospitalier Universitaire de Besancon

location_facility:
Centre georges-François Leclerc
Hôpital Nord Franche-Comté
CHU de Besançon


title: Retrospective Study of the Measurement of the Efficacy of MORPHINE in the Early Management of Dyspnea in COVID-19 Positive Patients With Moderate to Severe Impairment Without Objective of Resuscitation Management (Level of Care 3 and 4) at the Hospices Civils of Lyon

acronym: CODYS

summary:
Morphine is used in the treatment of dyspnea and polypnea with a proven benefit on the improvement of these symptoms, both etiologically and symptomatically. This medication is used in particular in palliative care for this type of symptom.

The Sars CoV2 viral pneumonia table can lead to respiratory distress. In patients with moderate to severe impairment without goal of resuscitation (level of care 3 and 4), the introduction of morphine may sometimes be necessary to relieve respiratory symptoms. These also lead to major exhaustion which can worsen the clinical picture. However, the prescription of morphine is not systematic in front of a respiratory distress table.

The investigators hypothesized that early treatment with morphine lead to a better management of dyspnea, quality of live and survival in COVID-19 positive participants patients when there is not resuscitation objective management (level of care 3 and 4).

The objective is to measure the efficacy of morphine in the early management of dyspnea, quality of life and survival in COVID-19 positive participants patients treated in the Hospices Civils of Lyon during COVID-19 pandemic.

lead_sponsor: Hospices Civils de Lyon

location_facility:
Hôpital Lyon Sud
Hôpital de la Croix Rousse / GHN
Hôpital Edouard Herriot


acronym: FLUCOLITH

title: Fluconazole as a New Therapeutic Tool in Hypercalciuric Patients With Increased 1,25(OH)2D Levels

source: euctr

ReferenceType: derived

ReferenceCitation: Bertholet-Thomas A, Portefaix A, Flammier S, Dhelens C, Subtil F, Dubourg L, Laudy V, Le Bouar M, Boussaha I, Ndiaye M, Molin A, Lemoine S, Bacchetta J. Fluconazole in hypercalciuric patients with increased 1,25(OH)(2)D levels: the prospective, randomized, placebo-controlled, double-blind FLUCOLITH trial. Trials. 2022 Jun 16;23(1):499. doi: 10.1186/s13063-022-06302-z.

location_facility: Service de Néphrologie Rhumatologie Dermatologie Pédiatrique

summary:
Hypercalciuria is one of the most frequent metabolic disorders associated with nephrolithiasis and/or nephrocalcinosis leading to Chronic Kidney Disease (CKD) and bone complications in adults.

Hypercalciuria can be secondary to increased intestinal absorption and/or increased renal distal tubular reabsorption of calcium due to increased active vitamin D, i.e. 1,25(OH)2D, levels. The management of hypercalciuria is challenging. Classic management based on hyperhydration and dietary advice has low impact on calciuria and therefore on CKD progression. Other strategies such as hydrochlorothiazide can be proposed, however with an uncertain medical benefit in view of side effects (hypokalemia, asthenia, potential cutaneous long-term side effects).

Azoles are known to inhibit the 1α-hydroxylase and therefore decrease 1,25(OH)2D levels. These antifungal drugs are commonly used in neonates, infants and adults; pharmacokinetic data are well described. Recently, to improve azoles tolerance, fluconazole has been successfully reported to reduce calciuria in patients with CYP24A1 mutation (1 adult) or NPTIIc mutations (1 child), while maintaining a stable renal function. Based on these observations, the investigators hypothesize that fluconazole is effective to decrease and normalize calciuria in patients with hypercalciuria and increased 1,25(OH)2D levels.

The primary objective is to demonstrate that fluconazole normalizes or decreases calciuria after 4 months of treatment in patients with hypercalciuria and increased 1,25(OH)2D levels.

The secondary objectives aim to describe:

the effects of fluconazole on the evolution over time of the calcium/phosphate metabolism,
the evolution of renal function,
the cohort at Baseline and after 4 months of treatment period,
the safety of fluconazole,
the onset of potential mycological resistances,
and the treatment compliance. This is a prospective, interventional, national, randomized in 2 parallel groups (1:1), controlled versus placebo, double blind trial.

This study will involve patients between 10 and 50 years of age suffering from nephrolithiasis and/or nephrocalcinosis with hypercalciuria (> 0.1 mmol/kg/d) and increased 1,25 (OH)2D levels (≥ 150 pmol/l) and 25-OH-D levels (≥50 nmol/L).

FLUCOLITH study is a unique opportunity to develop a new indication of a well-known and not expensive drug (e.g. fluconazole) in rare renal diseases, the ultimate objective being the secondary prevention of CKD worsening in these patients.

If the results of this proof-of-concept randomized controlled trial are positive, the investigators will propose an extension phase to evaluate the long term efficacy and safety of fluconazole on renal and bone parameters.


title: Predicting the Progression to Chronic Fibrosis of Lung Lesions Related to Covid-19 Infection From Chest CT Images

acronym: PREDISCAN

summary:
The main differences observed between SARSCoV-2 pneumonia and other epidemic viral pneumopathies (e.g., seasonal influenza) are the greater infectivity of SARSCoV-2, the clinical severity of the disease, particularly in young patients without co-morbidities, and the observation of radiological images related to significant parenchymal aggression in a large number of patients.

The lesions in the acute phase correspond essentially to bilateral ground glass opacity more or less associated with condensations which would be markers of more severe infections.

The major scope of the lesions in the acute phase raises the question of whether or not the scanning anomalies are completely resolved over time, and the possible impact on lung function. This risk of sequelae is very important to study given the large number of patients affected by SARSCoV-2, especially since these are often young patients who appear to be "healthy".

In the current context of the CoV-2 SARS pandemic, the improved quality and availability of diagnostic scanners provides a wealth of information on the semiology and progression of lung disease with minimal exposure to ionizing radiation. A majority of hospitalized patients with SARSCoV-2 received a CT scan in the early phase of the disease. Indeed, the French Society of Radiology has recommended the performance of a CT scan without injection in thin sections in case of suspicion or for confirmation of the diagnosis in patients presenting initial or secondary clinical signs of severity and justifying hospital management due to the initial lack of reagents for performing biological tests (RT-PCR) and the high sensitivity of the CT scan and its specificity in epidemic periods.

The present study aims to study the kinetics of lung involvement in SARS CoV 2, to study the predictive character of the chest CT scan performed at the patient's discharge on the existence of radiological sequelae at 3 months but also at 1 year in order not to misunderstand the constitution of late fibrosis after partial resolution of the CT images. The investigatos will study the correlation between possible radiological abnormalities and the clinical presentation (patient symptoms and lung function). The rigorous follow-up of these patients will allow us to set up, if necessary, early treatment of the detected abnormalities (inhaled corticoids in case of bronchial or bronchiolar damage, study of the place of an anti-fibrosis treatment in case of fibrosis,...).

lead_sponsor: Centre Chirurgical Marie Lannelongue

location_facility:
Institut Gustave Roussy (IGR)
Hôpital Saint Joseph
Hôpital Marie Lannelongue


title: Interest of the Virtual Reality Headset in the Management of Perioperative Stress in Patients Candidates for Total Thyroidectomy

acronym: ThyroVir

summary: Study the interest of hypnosis techniques by virtual reality based on the use of a virtual reality headset with the AQUA® application on the reduction of pre-operative stress in patients candidates for total thyroidectomy

lead_sponsor: Centre Francois Baclesse

location_facility:
CHU CAEN
Centre François Baclesse
Clinique Mathilde

intervention_type: Behavioral


title: Bioequivalence Study Between Temozolomide Oral Suspension (Ped-TMZ) and Temodal® Capsules

summary:
Primary objective:

• Evaluate bioequivalence between Temozolomide Oral Suspension and Temodal® capsules for oral administration.

Secondary objectives:

Define the pharmacokinetic parameters of Temozolomide Oral Suspension.
Assess the buccal safety of Temozolomide Oral Suspension.

lead_sponsor: Orphelia Pharma

location_facility: Service de neuro-oncologie - Hospices Civils de Lyon


title: Impacts of the Covid-19 Epidemic and Associated Lockdown Measures on the Management, Health and Behaviors of Cystic Fibrosis Patients During the 2020 Epidemic

acronym: MUCONFIN

summary: Impacts of the Covid-19 epidemic and associated lockdown measures on the management, health and behaviors of cystic fibrosis patients during the 2020 epidemic

lead_sponsor: Centre Hospitalier Intercommunal Creteil

location_facility:
TROUSSEAU Hospital
Intercommunal hospital of Créteil
FOCH Hospital


title: Changes in Serum antimüllerian Hormone Levels in Patients 3 and 12 Months After Endometrioma Sclerotherapy

acronym: ENDOPAL AMH

summary:
Endometriosis affects 6-10% of women in childbearing age. It is a heterogeneous disease with three different forms: superficial endometriosis (peritoneal), ovarian endometrioma and deep pelvic endometriosis (subperitoneal).

Surgical management of endometriomas is justified in cases of significant clinical symptoms (like pain), especially in cases of resistance to medical treatment. Currently, laparoscopic cystectomy surgery is the recommended technique to treat ovarian endometrioma. However, it is now well demonstrated that this surgery significantly reduces the ovarian reserve.

Ethanol sclerotherapy is an alternative technique used to treat ovarian endometriomas. Several studies demonstrated the effectiveness and safety of this treatment, particularly in terms of preserving fertility. Regarding these reassuring data, many clinicians changed their practices and propose this technique as a first-line surgery.

Ovarian reserve comprises two elements: size of the primordial follicle stock and quality of the ovocytes. Antimüllerian hormone (AMH) has been shown to be the best marker of fertility.

The aim of this study is to observe changes in AMH levels after endometrioma sclerotherapy. This study is conducted in the Hospices Civils de Lyon, in 3 different sites.

location_facility:
Hopital de la Croix Rousse
Hopital Femme Mère Enfant
Hopital Lyon Sud


title: Lyon Granulomatous Hepatitis Study

acronym: LGH

summary:
Granulomatous hepatitis are histopathologically defined by the presence of epithelioid and gigantocellular granulomas within the hepatic parenchyma. Hepatic granulomas are observed in 2 to 15% of liver biopsies. Causes of granulomatous hepatitis can be related to ethnic and environmental factors and in western countries granulomatous hepatitis are mostly related to sarcoidosis and autoimmune cholangitis. Infections (mycobacteria, coxiella burnetii, hepatitis C) and medications also provide granulomatous hepatitis.

Sarcoidosis is a systemic disease of unknown etiology, which in third of cases has a chronic course. Five percent of patients die of their disease, mainly because of respiratory distress. Hepatic involvement is most often asymptomatic or pauci-symptomatic (moderate cholestasis and conglomerates of granulomas visible on imaging). More rarely, it can cause portal hypertension and its complications and be life-threatening.

The aim of the Lyon Hepatitis Granulomatous (LHG) study is to better characterize granulomatous hepatitis and within these, severe hepatic sarcoidosis. This is a retrospective study conducted from January 2008 to December 2016 proposed to all patients with granulomatous hepatitis followed in the internal medicine and / or Hepato-gastroenterology departments (Croix-Rousse Hospital, Edouard-Herriot Hospital, Lyon Sud Hospital Center). This study will cover 596 patients who had a liver biopsy showing granulomas.

The main objectives of the Lyon Hepatitis Granulomatous (LHG) study are to analyze i) the etiology of the disease and the contribution of molecular biology for infectious etiologies, ii) the contribution of nuclear imaging for sarcoidosis diagnosis versus conventional imaging, iii) treatment used and prognosis.

This study will permit a better characterization of granulomatous hepatitis, and liver sarcoidosis in terms of prognosis as well as therapeutic management.

location_facility: Hôpital Lyon Sud / service de médecine interne

location_facility: : Hôpital de la Croix Rousse / GHN / service de médecine interne

location_facility: Hôpital Edouard Herriot / service de médecine interne


title: Randomized Trial in Assisted Reproductive Technology : Impact of pH Values of the Embryo Culture Medium on Live Birth Rate After In Vitro Fertilization (IVF)

acronym: ACIDOFIV

summary: The objective of this study is to compare, through a multicentric randomized trial, the impact of two pH values in the embryo culture medium on the clinical results of In Vitro Fertilization (IVF) process and especially the impact on live birth delivery rate.

lead_sponsor: University Hospital, Toulouse

location_facility:
CHU de TOULOUSE
Centre AMP BIOPYRENEES
CHU de BORDEAUX


title: Study of the Consequences of Infection on Compliance of Modalities of Decisions of Limitations and Stops of Treatments

summary: This survey is performed to examine if during the Covid's crisis, the practitionner's have respected the modalities of the law about the end of life, in particular concerning limitations and stop of therapeutics

lead_sponsor: University Hospital, Clermont-Ferrand

location_facility:
CHU de Clermont-Ferrand
CH de Vichy
Hospices Civiles de Lyon


title: Diagnostic Accuracy of Optimized Diffusion-Weighted Imaging for Detecting Anterior Ischemic Optic Neuropathy

acronym: DACODAC

summary: The patient presents to the ophthalmological emergencies and / or to the internal medicine department. NOIA clinical discovery Patient referred in radiology for brain and visual MRI. The two sequences added by the research (8 minutes) will be added to that of the treatment.

lead_sponsor: Fondation Ophtalmologique Adolphe de Rothschild

location_facility:
Chu Rouen
CHU de LILLE
Fondation A De Rothschild


title: Digitalization Playful Module of Motor Function Measure Assessment for Children With Neuromuscular Disorders, MFM-Play Pilot Study.

acronym: MFM-Play pilot

summary:
The Motor Function Measure (MFM) is a functional rating scale consisting of 32 items assessing motor functional abilities in a person with neuromuscular disease.

By exploring the potential of digital technologies applied to MFM, for each item completion we want to create digital animations containing different playful and informative scenarios. This digital evolution aims to standardize assessment on the therapist's side, but also to improve acceptance of scale and patient participation.

Despite the modification of the MFM completion by digital animation, the study hypothesis is that the metrological qualities of the scale are retained.

Through the MFM-Play pilot study, the objective is to test 5 items of the MFM-Play scale before carrying out a validation study of the total MFM-Play.

location_facility:
CHU Saint Etienne
Hospices Civils de Lyon
CHU de Grenoble


title: Screening for NAFLD-related Advanced Fibrosis in High Risk popuLation: Optimization of the Diabetology Pathway Referral Using Combinations of Non-invAsive Biological and elastogRaphy paramEters

acronym: NAFLD-CARE

summary: Nonalcoholic fatty liver disease (NAFLD) is being recognized as one of the most prevalent causes of chronic liver disease worldwide. The current strategy proposed by the EASL/EASO/EASD European guidelines for the screening of nonalcoholic fatty liver disease (NAFLD) in high-risk population such as type 2 diabetes and patients with obesity leads to an over-referral in hepatology clinics. The proposed study will investigate the optimal strategy for the screening of NAFLD-related advanced fibrosis in patients at high risk of fibrotic NAFLD, such as patients with T2DM or obesity by maximizing the positive predictive value (PPV) using non-invasive blood and elastography-based biomarkers in endocrinology/diabetology clinics in order to reduce the over-referral to hepatology clinics.

primary_purpose: Screening

location_facility: Centre Hospitalier Universitaire Dijon Bourgogne


title: Patients and Health Staff of Cancer Centres During the Covid-19 Pandemic: Constitution of a Biological Collection Linked to a Prospective, Multicenter Cohort Study

summary: The Covid-19 has, in a few weeks, made the world tremble: the number of deaths (mainly elderly and / or co-morbid) continues to increase, the confinement causes the collapsing of the economy and the decline of relationships inter-human. The data are too fragmented and the disease too recent to know its repercussions on the 3 million French people who have or have had cancer. The investigators would like, in 3 populations: * patients in treatment, * or in follow-up and * health personnel, to constitute a large prospective and longitudinal database of data: i / serological: humoral response, test performance, monitoring of serum immunoglobulin levels , reinfection threshold,…; ii / clinical: incidence, severity, mortality and their favorable factors impact of cancer treatment on Covid-19 infection and modification of the quality of oncological care in the context. In parallel, on a more limited sample of establishments, it will be : * appreciate the economic and functional repercussions, * will try to find out about the infection modalities in patients and health personnel and * will appreciate the levels of anxiety and depression to which health staff are subject.

lead_sponsor: Institut Cancerologie de l'Ouest

location_facility:
Centre Jean Perrin
Institut de Cancérologie de Lorraine
Institut de Cancerologie de l'Ouest


title: Impact of Nociceptive-Level (NOL) Intraoperative Guided Remifentanil Analgesia Versus Standard Clinical Care (SCC) for Elective Major Abdominal Surgery

acronym: Eu-MultiNOL

summary:
The Physiological Monitoring Device (PMD-200™) system is comprised of a monitor and a designated finger probe containing 4 sensors. The sensors included are Photoplethysmography (PPG), Galvanic Skin Response (GSR), Accelerometer for movement (ACC) and Thermistor for peripheral temperature (TMP).

The PMD-200 is intended to be used for assessing the nociception level in anesthetized patients.

The purpose of the study is confirmation of a reduction in the dosage of remifentanil allowed by the monitoring of nociception by the NOL which could open the way to a double control of the administration of anesthetic agents: control of the administration of hypnotics by the bispectral index (BIS) and control of the administration of opiate by the NOL.

ReferenceType: result

ReferenceCitation: Meijer FS, Martini CH, Broens S, Boon M, Niesters M, Aarts L, Olofsen E, van Velzen M, Dahan A. Nociception-guided versus Standard Care during Remifentanil-Propofol Anesthesia: A Randomized Controlled Trial. Anesthesiology. 2019 May;130(5):745-755. doi: 10.1097/ALN.0000000000002634.

lead_sponsor: Hopital Foch

location_facility: Hôpital d'Instruction des Armées - Sainte-Anne

location_facility: Hopital d'Instruction des Armées de Bégin


title: Identify the Obstacles to Early Diagnosis of Cancer in Patients Over 75 Years Old, on an Outpatient Basis

acronym: DPCMG

summary:
A third of cancers are diagnosed in patients over 75 years of age. There are fears of the elderly talking about new symptoms. The doctor may find himself trapped by general symptoms, which can be confused with "normal aging".

Some older, younger people have lived in a world where cancer was little talked about, where there was little treatment possible.

There is an idea that doctors are not very quick to start curative treatment because they think that the elderly cannot bear it.

It is important to differentiate screening and early diagnosis.

Delayed treatment causes a decrease in survival and quality of life. Cancer can be discovered suddenly: for example, occlusion with peritonitis in case of a stenosing colonic tumor, leading to urgent management.

The elderly are often excluded from clinical studies.

In addition, the geriatric population is heterogeneous, leading to very diverse and individual care, with prioritization of issues.

Oncogeriatrics, which combines two services (oncology and geriatrics), is a specialized discipline, promoting comprehensive care for the elderly patient with cancer.

The general practitioner is at the center of care. It detects early signs and starts examinations if necessary.

Cancer care can be divided up with the different stages of care with various teams, including organ specialists.

The general practitioner is the privileged interlocutor for the patient and their family (medico-psycho-social plan), who knows their history and their experience.

location_facility:
Centre Léon Bérard
Hôpital Lyon Sud
Centre hospitalier Fleyriat


title: Study of the Prevalence of Deep Vein Thrombosis in Patients Hospitalized in Intensive Care for Acute Respiratory Failure Linked to Pneumonia Documented With SARS-COV2

acronym: CLOT

summary:
Coronavirus 2 (SARS-CoV2) has been identified as the pathogen responsible for severe acute respiratory syndrome associated with severe inflammatory syndrome and pneumonia (COVID-19).

Haemostasis abnormalities have been shown to be associated with a poor prognosis in these patients with this pneumonia. In a Chinese series of 183 patients, the hemostasis balance including thrombin time, fibrinogenemia, fibrin degradation products and antithrombin III were within normal limits. Only the D-Dimer assay was positive in the whole cohort with an average rate of 0.66 µg / mL (normal <50 µg / mL). These hemostasis parameters were abnormal mainly in patients who died during their management; the levels of D-dimers and fibrin degradation products were significantly higher while the antithrombin III was reduced. The findings on the particular elevation of D-dimers in deceased patients as well as the significant increase in thrombin time were also reported in another series. Higher numbers of pulmonary embolisms have been reported in patients with severe form of SARS-COV2 (data in press).

This research is based on the hypothesis that the existence of deep vein thrombosis (DVT) could make it possible to screen patients at risk of pulmonary embolism and to set up a curative anticoagulation.

The main objective is to describe the prevalence of deep vein thrombosis in patients hospitalized in intensive care for acute respiratory failure linked to documented SARS-COV2 pneumonia, within 24 hours of their admission.

lead_sponsor: Ramsay Générale de Santé

location_facility:
Hôpital Privé Jacques Cartier
Hôpital Ambroise Paré
Centre Cardiologique du Nord


title: Efficacy Study of a Selective Chest Wall Restriction Belt in Postoperative of Lung Resection. A Multicenter, Prospective, Controlled, Randomized Study With Stratification on the Surgical Approach, Open With a Blind Analysis

acronym: CTS-POP

summary:
The objective of this study is to evaluate the efficacy of a new medical device in post-surgery of lung resection. The principle of this new device is based on selective chest wall restriction. This new modality of chest wall restriction is evaluated on patients in post-surgery for lung cancer.

The hypothesis is that the use of this medical device would reduce the postoperative pain and increase the efficacy of cough and expectoration. The evolution of the operated patient would be better.

lead_sponsor: University Hospital, Grenoble

location_facility: Assistance Publique Hôpitaux de Paris, Hôpital Avicenne


status: Terminated

acronym: JAKINCOV

title: Interleukin-1 (IL-1) and Interferon Gamma (IFNg) Inhibition During COVID 19 Inflammation: Randomized, Controlled Study Assessing Efficacy and Safety of Anakinra and Ruxolitinib

lead_sponsor: Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer

ReferenceCitation: Mehta P, McAuley DF, Brown M, Sanchez E, Tattersall RS, Manson JJ; HLH Across Speciality Collaboration, UK. COVID-19: consider cytokine storm syndromes and immunosuppression. Lancet. 2020 Mar 28;395(10229):1033-1034. doi: 10.1016/S0140-6736(20)30628-0. Epub 2020 Mar 16.

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

ReferenceCitation: Zalinger ZB, Elliott R, Weiss SR. Role of the inflammasome-related cytokines Il-1 and Il-18 during infection with murine coronavirus. J Neurovirol. 2017 Dec;23(6):845-854. doi: 10.1007/s13365-017-0574-4. Epub 2017 Sep 11.

location_facility:
Sainte Anne Teaching Military Hospital
Hôpital Sainte-Musse
AP-HM, Hôpital de la Conception

summary: During SARS-Cov2 infection with serious respiratory implication and high systemic inflammation level, intravenous ANAKINRA alone or associated with RUXOLITINIB for severe cases might reduce inappropriate systemic inflammatory response, improve breathing and decrease occurrence or duration of ARDS and associated mortality.


title: Azithromycin With Amoxicillin/Clavulanate Versus Amoxicillin/Clavulanate Alone in COVID-19 Patients With Pneumonia and Hospitalized in a Non-intensive Care Unit Ward (AziA): a Superiority Open-label Randomized Controlled Trial

acronym: AziA

summary: The global pandemic of novel coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) began in Wuhan, China, in December 2019, and has since spread worldwide.1 As of April 14, 2020, there have been more than 1.5 million reported cases and 124 000 deaths in more than 200 countries. A recent open-label nonrandomized French study reporte that addition of azithromycin to hydroxychloroquine in 6 patients resulted in numerically superior viral clearance (6/6, 100%) compared with hydroxychloroquine monotherapy (8/14, 57%) or control (2/16, 12.5%). Azithromycin alone has never been tested, whereas azithromycin has immunomodulating and anti-inflammatory properties that could theoretically prevent or limit secondary worsening. Our hypothesis is that azithromycin combined with amoxicillin/clavulanate will be superior to amoxicillin/clavulanate alone to obtain viral clearance at Day 6 in COVID-19 patients with pneumonia and hospitalized in a non-intensive care unit ward.

lead_sponsor: Nantes University Hospital

location_facility:
CHU Poitiers
Chu Angers
CHD Vendée


title: Study of the Dissemination of SARS-COV-2 in the Environment of Infected Patients Admitted to Intensive Care Unit

acronym: ENVIROREA

summary: The objective of this protocol is to estimate the proportion of patients hospitalized in intensive care unit for a SARS-Cov-2 viral lung infection and contaminating their environment at 1 meter. The contamination will be assessed by quantifying the viral RNA by RT-PCR on a 600-liter air sample aspirated by a Coriolis® system. This sample will be taken within 48 hours after the confirmation of SARS-Cov-2 infection, documented by RT-PCR. In fact, the hospital hygiene measures practiced in intensive care unit in patients with viral respiratory infection are identical to those practiced in other services. These measures are possibly insufficient as evidenced by recent data related to the COVID-19 epidemic.

lead_sponsor: Assistance Publique - Hôpitaux de Paris

location_facility:
Service de réanimation Hôpital Bichat
Service de réanimation Hôpital Tenon
Service de réanimation Hôpital Avicenne


title: Study of Immune Response During SARS-CoV-2 Infection

acronym: CovImmune

summary:
Study of the cellular immune response during the SARS-CoV-2 infection and identify cytokinic profiles in caregivers exposed to the virus with asymptomatic forms of COVID19, patients with an asymptomatic form followed in ambulatory care and patients hospitalized in the infectious disease department or in resuscitation at the CHU de Nice COVID-19 according to their clinical symptomatology and the kinetics of clinical aggravation using functional tests evaluating the Th1 type immune response.

The project is divided into a clinical component comprising the study of the immune response in different populations and a cellular component focusing on the in vitro study of different immunomodulating treatments on their ability to induce an anti-viral Th1

lead_sponsor: Centre Hospitalier Universitaire de Nice

location_facility:
Antibes Hospital
Cannes Hospital
Nice Hospital


title: Impact of the COVID-19 Pandemic on Changes in Therapeutic Strategies in Gynecological Oncology

acronym: COVID-GYN

summary: The current infection with the Coronavirus SARS-CoV-2 (COVID-19) is an exceptional health situation which requires an adaptation of our management practices in gynecological oncology. Data from the literature suggest that infection with Coronavirus is serious in subjects with cancer with a risk of severe form 5 times higher than that of the population without cancer and a risk of death multiplied by 8. In addition, the risk of infection would be 3 times greater in case of cancer. Faced with the COVID-19 epidemic, the investigator must organize themselves to ensure continuity in the treatment of patients with gynecological cancer but also adapt our practices in the management (CPR, teleconsultation, adaptation of treatment or even postponement of treatment). The objective of the High Council of Public Health is to be able to ensure adequate oncological care avoiding any potential loss of chance concerning the care of cancer: people affected must, despite the pandemic, have care allowing the same level of curability (localized cancers) or the same life expectancy (advanced cancers). This must be done by limiting as much as possible the impact on the organization of the service, the organization of patient follow-up and the psychological impact that these possible modifications could have. The hypotheses of our study are that the exceptional health situation linked to this pandemic leads to a change in the care of patients with gynecological cancer associated with a psychological impact and increased anxiety of patients during their care. Despite the extent of the pandemic, very little existing data makes it possible to define recommendations with a sufficient level of evidence.

location_facility: Service Gynécologie, CHLS, Hospices Civils de Lyon

location_facility: Service de Gynécologie, HFME, Hospices Civils de Lyon

location_facility: Service de Gynécologie, Croix-Rousse, Hospices Civils de Lyon


title: Emotional Burden of Healthcare Professionals and the Epidemic Related to Covid Infection 19 -

acronym: Emocovid

summary:
COVID-19 ( known as severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2)) has a highly polymorphic clinical presentation, ranging from pauci-symptomatic infection to severe, potentially complicated forms with acute respiratory distress syndrome or multisystemic organs failure. The picture may be initially severe, or it may progress in two stages, with worsening 7 to 10 days after the first symptoms with an overall case-fatality rate of 3 to 4%.

Its management is essentially symptomatic, as no antiviral treatment has so far demonstrated a clinical benefit in this condition.

In such a context, healthcare professionals assigned to COVID units will be faced with a heavy workload and emotional burden that could lead to psychological suffering or even burnout and its consequences.

We would therefore like to describe, using validated tools, the emotional evolution of the care workers at the Limoges University Hospital and the Esquirol University Hospital faced with this new pandemic infection. An initial and end-of-study evaluation of the caregivers will be carried out concerning their anxiety and depressive state, their personal capacity for resilience and their degree of empathy

lead_sponsor: University Hospital, Limoges

location_facility:
CHU de Limoges
CH Esquirol
HCL LYON


title: 18F-Fluorocholine (FCH) Versus 18F-Fluorodesoxyglucose (FDG) PET/CT in Detection of Lesions in Patients With Multiple Myeloma

acronym: MIM

summary:
Hybrid positron emission tomography/computed tomography (PET/CT) has now become available to detect tumors in patients with multiple myeloma. The radioactive glucose 18F-fluorodeoxyglucose (FDG) is the most widely used tracer but findings suggest that PET/CT reveal more lesions when using FCH.

In this study, FDG is compared with a more recent metabolic tracer, 18F-fluorocholine (FCH), for the detection of multiple myeloma lesions at time of initial extension assessment.

The principal objective of this sudy is to compare the number of suspected hypermetabolic foci of myeloma detected by 18F-fluorocholine PET and by 18F-fluorodeoxyglucose PET during the initial extension assessment.

lead_sponsor: Centre Georges Francois Leclerc

location_facility:
CHU de Dijon
Centre Georges François Leclerc
CHU de Besançon


title: Cohort Multiple Randomized Controlled Trials Open-label of Immune Modulatory Drugs and Other Treatments in COVID-19 Patients CORIMUNO-COAG Trial

acronym: CORIMMUNO-COAG

summary:
COVID-19 is a respiratory disease caused by a novel coronavirus (SARS-CoV-2) and causes substantial morbidity and mortality. There is currently no vaccine to prevent Covid-19 or infection with SARS-CoV-2 or therapeutic agent to treat COVID-19.

This protocol CORIMUNO19-COAG will evaluate the efficacy and safety of active anticoagulation using heparin: Tinzaparin (INNOHEP®) or unfractionated heparin (Calciparine®, Héparine Sodique Choay®) in COVID-19 patients hospitalized in conventional or intensive care units.

It will use a phase 2 randomized open-label multicentre clinical trial, where patients will be randomly allocated to anticoagulation versus Standard of Care.

ReferenceCitation: Flumignan RL, Civile VT, Tinôco JDS, Pascoal PI, Areias LL, Matar CF, Tendal B, Trevisani VF, Atallah ÁN, Nakano LC. Anticoagulants for people hospitalised with COVID-19. Cochrane Database Syst Rev. 2022 Mar 4;3:CD013739. doi: 10.1002/14651858.CD013739.pub2. Review.

ReferenceCitation: Flumignan RL, Tinôco JDS, Pascoal PI, Areias LL, Cossi MS, Fernandes MI, Costa IK, Souza L, Matar CF, Tendal B, Trevisani VF, Atallah ÁN, Nakano LC. Prophylactic anticoagulants for people hospitalised with COVID-19. Cochrane Database Syst Rev. 2020 Oct 2;10:CD013739. doi: 10.1002/14651858.CD013739. Update in: Cochrane Database Syst Rev. 2022 Mar 4;3:CD013739.

location_facility: Médecine vasculaire, Hôpital Européen Georges Pompidou


title: Management by Hyperbaric Oxygen Therapy of Patients With Hypoxaemic Pneumonia With SARS-CoV-2 (COVID-19)

summary:
Several patients with hypoxaemic SARS-CoV2 pneumonia were able to benefit from hyperbaric oxygen treatment (HBOT) in China. In a clinical case published in the Chinese journal of hyperbaric medicine, treatment with repeated HBO sessions prevented admission to intensive care unit with mechanical ventilation in a patient aged 69 who presented with signs of respiratory decompensation. HBOT is the most powerful oxygenation modality in the body today. HBOT can dramatically increase the amount of dissolved oxygen in the blood. HBOT not only promotes blood transport but also its tissue delivery. Furthermore, HBOT has specific immunomodulatory properties, both humoral and cellular, making it possible, for example, to reduce the intensity of the inflammatory response and to stimulate antioxidant defenses by repeating sessions. A virucidal capacity of HBOT might also be involved. HBOT is generally regarded as safe with very few adverse events.

Following this feedback, it is proposed in the context of crisis management related to SARS-CoV2 to assess the value of HBO treatment of patients with CoV2 pneumonia. Indeed, it seems essential to propose therapeutic strategies to limit the risk of respiratory decompensation requiring admission to intensive care unit for patients with SARS-CoV2 pneumonia.

lead_sponsor: Direction Centrale du Service de Santé des Armées

location_facility: Hôpital d'Instruction des Armées Laveran

location_facility: Hôpital d'Instruction des Armées Sainte-Anne

location_facility: Centre Hospitalier Intercommunal de Toulon - La Seyne-sur-Mer


title: Chronic Airway Disease, Mucus Rheology and Exacerbations: a Randomized Controlled Trial of COPD Patients

acronym: COPD-CARhE

summary: The main objective of this trial is to compare the exacerbation rates over 12 months of follow-up between a group of patients with COPD treated according to standardized management (azithromycin prescribed in the event of severe sputum according to the CASA-Q score , standardized comparator arm) and a similar group in which azithromycin is prescribed based on mucus rheology (experimental arm) or CASA-Q.

ipd_sharing_description:
The general goal is to make the study data available to interested researchers as well as to provide proof of transparency for the study. Data (and an accompanying data dictionary) will be de-identified and potentially further cleaned or aggregated as the investigators deem necessary to protect participant anonymity.

Data will be made available to persons who address a reasonable request to the study director and fulfil the requirements stipulated by the French CNIL (Commission Nationale de l'Informatique et des Libertés : https://www.cnil.fr/professionnel).

lead_sponsor: University Hospital, Montpellier

location_facility:
University Hospitals of Toulouse
University Hospitals of Bordeaux
University Hospitals of Montpellier


title: An Evaluation Study on the Performance of a Guided Clinical Pharmacy Consultation for Patients With Multiple Myeloma Following Their First Oral Anticancer Treatment

acronym: CPS MYELOME

summary:
Nowadays, more and more patients are receiving anticancer treatment by mouth and oral chemotherapy is a challenge for our health system as patients become autonomous and responsible for following their oral anti-cancer treatment at home.

According to the French National Cancer Institute around 5.000 new cases of multiple myeloma (MM) are detected each year, and this figure is on the increase. It is more common in people aged over 70. The patterns of oral anticancer medication for multiple myeloma are complex and these patients do not always follow their treatment correctly. A clinical pharmaceutical consultation guide was designed to overcome this problem.Our hypothesis is that the guided consultation would minimize the rate of discrepancies observed compared with the usual, standard type of management.

The main objective is therefore to evaluate the performance of this guided consultation (interventional group) in comparison with a control group (standard management) for patients with multiple myeloma on their first cure of oral anticancer medication.

lead_sponsor: Centre Hospitalier Universitaire de Nīmes

location_facility:
Nîmes University Hospital
Dijon University Hospital Pharmacy
Perpignan Hospital Center


title: Hypercapnic Acute Respiratory Failure in the ICU : the YETI Study

acronym: YETI

summary:
Hypercapnia is a frequent clinical situation defined as an elevation of the partial pressure of carbon dioxide (PaCO2) above 45 mmHg. Several physiopathological parameters such as respiratory minute volume, dead space volume or CO2 production influence the PaCO2. Therefore, hypercapnia can affect the time of various diseases.

Available epidemiological data regarding hypercapnia are from studies investigating the efficacy of non-invasive ventilation (NIV), with different population cohorts. However, their interpretation must be cautious given the heterogeneity in patient case-mix and results.

Then, whether hypercapnia is a common reason for intensive care unit (ICU) admission, epidemiological data is scarce and heterogeneous. The aim of this study is to investigate the epidemiological, clinical determinants and outcomes of patients admitted to ICU with hypercapnic respiratory failure.

lead_sponsor: French Society for Intensive Care

location_facility:
CHU Nantes
CH Andre Migniot
CHU Toulouse


title: Randomised Multicentric Phase III Study Evaluating the Efficacy of Cicaderma vs Standard Management of Each Site in Preventing Radiodermatitis After Adjuvant Post-operative Breast Irradiation in Patients With Non-metastatic Breast Cancer

acronym: CICA-RT

summary: Phase III, prospective, interventional, multicentric, comparative, randomized, open study with 2 parallel arms, evaluating the efficacy of Cicaderma ointment vs standard management of each site in preventing the onset of grade > 2 radiodermatitis according to the National Cancer Institute - Common Terminology Criteria for Adverse Events-Version (NCI-CTCAE-V5)

lead_sponsor: Centre Leon Berard

location_facility:
Institut Sainte-Catherine
Institut Curie


title: Prospective, Multi-center Evaluation of the Accuracy of Non-invasive Measurement of Blood Pressure Using an Arm, Calf and Finger Cuff.

acronym: PANIC

summary: The present study was designed to assess, in a population of patients admitted to the intensive care unit and already carrying an indwelling arterial catheter, the ability of combined continuous (ClearSight™) and intermittent (automatic cuff) non-invasive monitoring to detect low mean BP (<65mmHg). The intra-arterial measurement will be the reference measurement. As secondary objectives, the investigators will assess the ability of combined continuous (ClearSight™) and intermittent (automatic cuff) non-invasive monitoring to detect stage 2 hypertension, and to detect changes in BP during a cardiovascular intervention (as clinically indicated but not imposed by the study protocol). Additionally, the accuracy of both devices against the current international standard (ISO standard) will be assessed.

lead_sponsor: Centre Hospitalier Régional d'Orléans

location_facility:
CHRU de Tours
CHR Orléans
CHU de NANTES


title: Non-inferiority Study of the Molecular Imaging of Dopamine Transporters Using [123I]-FP/CIT-SPECT and [18F] LBT-999-PET to Distinguish Between Parkinson's Disease and Essential Tremor.

summary: Clinical study to demonstrate an at least equivalent performance of a new PET molecular Imaging radiopharmaceutical named [18F] LBT-999 in brain imaging compared to the SPECT reference method named [123I]-FP-CIT to establish the differential diagnosis between Parkinson's Disease and Essential Tremor.

lead_sponsor: Zionexa

location_facility: Centre Hospitalier Universitaire de Nîmes

location_facility: Centre Jean PERRIN / Hôpital Gabriel Montpied (CHU)

location_facility: Hôpital Pierre Paul Riquet - Purpan (CHU)


title: Impact of a Food Improvement Strategy on Their Appreciation in a Population of Cancer Patients Treated With Chemotherapy

summary:
Cancer promotes weight loss; it can also lead to particular complications for patients during treatment. A team led by Dr Michael Sawyer, showed the deleterious impact of undernutrition on the benefits of chemotherapy.

Cancer patients are at high risk of undernutrition, which is generally more pronounced for solid tumours (upper digestive tract, ENT, bronchial tubes…). This undernutrition leads to major weight loss and wasting, and may represent the first sign of a call for a diagnosis of cancer. Cancer-related undernutrition is multi-factorial in origin and has multiple consequences; it has its own prognostic value.

Chemotherapy treatments can induce various adverse effects in patients, including sensory disturbances at the beginning of treatment in addition to disturbances that may already be present before any treatment. Altered taste and odour, observed in 86% of patients, can induce a change in food preferences, promote the development of aversions, and therefore, lead to a significant reduction in the pleasure of eating. Loss of appetite, decreased food intake and the development of aversions to certain foods are situations experienced by a large proportion of patients undergoing chemotherapy.

The assessment of taste disorders in patients undergoing chemotherapy treatment is established through the use of questionnaires, interviews and taste tests.

Changes in the perception and identification of salty, sweet, bitter and sour flavours are common in patients undergoing chemotherapy.

The objective of CANUT is to study the effect of pathology and chemotherapy on gustatory and olfactory mechanisms and in particular on interindividual differences in the perception and appreciation of food.

In this study the investigators propose to adapt foods to best respond to sensory disorders related to the disease and/or treatment.

primary_purpose: Health Services Research

lead_sponsor: Hospices Civils de Lyon

location_facility: Hôpital de jour - Hôpital de la Croix Rousse

intervention_type: Dietary Supplement


title: Ultrasound Abnormalities of the Salivary Glands in Primary Sjögren's Syndrome

acronym: MASAÏ

summary:
Salivary gland ultrasonography is identified as a valuable diagnostic tool and potential criteria item for disease classification of sjögren's syndrome and evaluate evolution of parenchyma.

The investigators have to include 242 patients. The objective is to evaluate the modification of ultrasonographic abnormalities according to disease in primary Sjögren syndrome.

lead_sponsor: University Hospital, Brest

location_facility:
CHU de LILLE
CHU de MONTEPELLIER
CHRU de Brest


title: Développement d'un modèle prédictif du Risque de Survenue d'évènements Thromboemboliques Veineux Chez Les Patients Atteints de Cancer Broncho-pulmonaire métastatique

acronym: LUCAAT

summary:
Venous thrombo-embolism (VTE) is a frequent and serious complication of cancer. However, predictive tools for VTE in cancer patients is lacking.

In patients with metastatic broncho-pulmonarycancer, biochemical characteristics might help to identify patients at high risk for VTE.

The aim of this study is to derive a predictive score combining clinical and biochemical variable that predict VTE in metastatic broncho-pulmonary cancer.

location_facility:
CHIC de QUIMPER
CH des Pays de Morlaix
CHRU de Brest


title: Signature of the Risk Profile of Mortality in a Hospital Cohort of Patients With Metabolic Diseases

acronym: INTEGRA

summary:
Epidemiological studies are usually conducted in the general population in adults without complications or pathology at baseline. The results obtained are therefore often better designed for primary prevention use. The prediction of mortality risk in patients with complications and requiring hospital follow-up is less well known.

The study purpose is to determine a mortality risk profile in a hospital cohort of patients with pathologies associated with metabolic diseases.

Today the "multimaker" scores based on a panel of biomarkers - have significantly improved the discriminating power of prediction models existing in many pathologies. It is no longer a single biomarker that can improve risk prediction but a complete and cross-sectional profile that is sought after. We aim to establish a personalised mortality risk profile by combining clinical and biological parameters including metabolomics, genetics, transcriptomics and epigenomics by high throughput screening of biological samples.

lead_sponsor: University Hospital, Lille

location_facility:
Hop Claude Huriez Chr Lille
Hop Cardiologique Chr Lille
Ch Boulogne-Sur-Mer


title: Study to Measure the Impact of Probiotics on Immune Activation and Neurocognitive Disorders in HIV-positive Patients With Neurocognitive Disorders

acronym: PROCOG

summary:
The prevalence of HIV-associated neurocognitive disorders (Human Immunodeficiency Virus) remains high during the era of effective triple therapy. The main clinical phenotypes of cognitive impairment are currently represented by asymptomatic neurocognitive neurocognitive impairment (ANI) and mild neurocognitive disorders (MND). In contrast, HIV-associated dementia has almost disappeared.

Among the hypotheses to explain the persistence of such a high prevalence is the persistent activation of the immune system despite virological success. This chronic immune activation is believed to be responsible for an inflammatory response and therefore for accelerated cell aging. Several organ complications in HIV-positive patients have been associated with high markers of immune activation.

Among the causes of chronic immune activation in virologically controlled patients, an imbalance in the intestinal flora is suspected. In fact, shortly after HIV infection, the virus causes significant apoptosis of intestinal lymphocytes, responsible for a loss of integrity of the intestinal barrier and an imbalance of flora, defined as "dysbiosis".

Loss of epithelial integrity and intestinal dysbiosis are suspected of causing systemic passage of bacterial fragments, of which lypopolisaccharide is best known, resulting in chronic activation of the immune system. Several studies suggest a link between digestive bacterial translocation and HIV-related neurocognitive disorders. An improvement in intestinal dysbiosis could therefore contribute to reducing immune activation and the severity of cognitive impairment. A recent study showed that probiotics can reduce levels of neopterin, a marker of monocytic activation, in the cerebrospinal fluid of HIV-positive patients without neurological symptoms.

Our objective is to evaluate the impact of probiotic supplementation on immune activation and cognitive performance in virologically controlled HIV-positive patients with a diagnosis of ANI or MND. The potential improvement of cognition through probiotic treatment could therefore improve their quality of life at a lower cost than a drug and without the risk of serious side effects.

location_facility:
CHU Montpellier
CH Cannes
CHU de Nice


title: DEGENERATIVE DISC DISEASE TREATED BY DECOMPRESSION AND ARTHRODESIS USING A PEEK-TITANIUM POLYAXIAL INTERSPINOUS POSTERIOR FUSION DEVICE: ROMEO®2 PAD. 2 YEARS PROSPECTIVE FOLLOW-UP

acronym: ROMEO 2 PAD FR

summary:
This study is designed as a post-marketing observational, controlled, prospective, non-inferiority study where the efficacy and safety of the Degenerative Disc Disease treatment by arthrodesis using PEEK(PolyEtherEtherKetone)-Titanium polyaxial interspinous posterior fusion device ROMEO®2 PAD will be compared to the gold standard treatment by instrumented circumferential arthrodesis.

The primary study aim is to evaluate functional improvement at 1 and 2 years after surgery. The fusion at 1 year and 2 years post-surgery, the short and long- term clinical and neurological success and patient related health status satisfaction will also be evaluated.

lead_sponsor: Spineart SA

location_facility:
Clinique St Jean
CHU Gui de Chauliac
Hôpital de la Timone


title: HUSH Restriction in HIV Infected Patients

summary: HIV eradication faces a major obstacle that is viral persistence in latent reservoir cells despite antiretroviral therapy. Epigenetic repression plays a central role in viral transgene latency and several epigenetic regulators have been involved in this process. Among them, the "Human Silencing Hub" or HUSH complex, composed of Tasor, MPP8 and periphilin, has been shown to recruit the H3K9me3 methyltransferase "SET domain bifurcated 1" (SETDB1) and is therefore responsible for genes' epigenetic repression. Our recent results highlight the ability of Vpx from HIV-2/SIVsmm to counteract HUSH and to reactivate latent viruses in a latency model. We propose here to study HUSH activity along pathogenesis.

lead_sponsor: ANRS, Emerging Infectious Diseases

location_facility:
Hôpital Necker
Hôpital Bicêtre
Hôtel-Dieu


title: Impact of Preoxygenation Time on End-tidal Oxygen Concentration and on Hypoxic Events Occurring After Intubation in the Intensive Care Unit.

acronym: IMPROVE

summary: Preoxygenation is recommended before performing tracheal intubation. In intensive care units (ICU) patients, there is no specific recommendation regarding the duration of preoxygenation, which usually is applied for 3 to 5 minutes. Monitoring the effectiveness of preoxygenation with end-tidal oxygen concentration (EtO2) is strongly recommended in the operating room but it is never used in ICUs. The first aim of this pilot study is to assess the effect of the preoxygenation duration on EtO2, and secondarily, as an exploratory objective, to determine whether targeting a given value of EtO2 during preoxygenation might insure a safer intubation than when targeting pulse oximetry (SpO2).

ReferenceCitation: Carrillo A, Gonzalez-Diaz G, Ferrer M, Martinez-Quintana ME, Lopez-Martinez A, Llamas N, Alcazar M, Torres A. Non-invasive ventilation in community-acquired pneumonia and severe acute respiratory failure. Intensive Care Med. 2012 Mar;38(3):458-66. doi: 10.1007/s00134-012-2475-6. Epub 2012 Feb 9.

ReferenceCitation: Thille AW, Frat JP, Brun-Buisson C. Trends in use and benefits of non-invasive ventilation as first-line therapy in acute respiratory failure. Intensive Care Med. 2014 Aug;40(8):1179-80. doi: 10.1007/s00134-014-3370-0. Epub 2014 Jun 25.

ReferenceCitation: Ozsancak Ugurlu A, Sidhom SS, Khodabandeh A, Ieong M, Mohr C, Lin DY, Buchwald I, Bahhady I, Wengryn J, Maheshwari V, Hill NS. Use and outcomes of noninvasive positive pressure ventilation in acute care hospitals in Massachusetts. Chest. 2014 May;145(5):964-971. doi: 10.1378/chest.13-1707.

location_facility:
CHRU de TOURS
CHR d'Orléans
CH de DAX