title: Anti-Covid-19 Vaccine Protection in Immunocompromised Children (1 to 15 Years Old) With Acute Leukemia and Their Siblings (≥12 Years Old). Phase I-II Trial Evaluating Post-vaccine Safety and Humoral and Cellular Immunogenicity.

acronym: PACIFIC

summary:
Mortality in case of SARS-CoV-2 infection (Covid-19) during acute leukemia (AL) treatment is around 30%, i.e. more than 10 times the one of general population. Severe forms are reported in children receiving chemotherapy for AL. However, the main risk, largely underestimated, is related to delay in chemotherapy administration in case of infection, leading to an increased risk of relapse. Therefore, it is justified to propose an anti-Covid-19 vaccination to these patients. Vaccination of siblings also seems necessary given the uncertainty regarding vaccine response in children with AL and given that household is the main source of contamination. The messenger ribonucleic acid (mRNA) vaccine COMIRNATY® (BNT162b2) is already approved by health authorities for individuals older than 12. In immunocompromised children with AL, safety and efficacy data are unknown. The benefit/risk balance encourages to use the vaccine without health authority approval in children aged 1 to 15 with AL. Regarding household, parents are vaccinated for several months as standard of care, but vaccination will be proposed to siblings aged 12 to 15 years old in this protocol.

The primary objective of this study is to evaluate safety and immunogenicity of COMIRNATY® (BNT162b2) vaccine (two injections 21-28 days apart) in children with acute leukemia (1 to 15 years old) and their siblings (≥12-15 years old).

A secondary objective of the study is to compare the quality of humoral and cellular vaccine responses in children with AL and healthy children.

lead_sponsor: Assistance Publique - Hôpitaux de Paris

location_facility:
Hôpital Armand Trousseau
Hôpital Robert Debré


title: Electrophysiologic Study of Perioperative Monitoring of the Recurrent Laryngeal Nerve: Impaired Vocal Cord Movement After Thyroidectomy

acronym: NERLICORDE

summary: Paralysis of the recurrent (or inferior) laryngeal nerve (RLN or ILN) is one of the most common and most serious complications of thyroid surgery. Neuromonitoring of the inferior laryngeal nerve (ILN or recurrent) is a technique currently used during thyroidectomy to locate ILN during dissection. Detector electrodes are placed in contact with vocal muscle which is stimulated electrically at the location of ILN, producing an acoustic and visual signal. This is a basic electromyographic technique whose diagnostic and prognostic potential for the entire neuromuscular system has not yet been fully explored. The study of action potentials generated by the stimulation-detection of nerves ILN and vagal nerves at the beginning and end of dissection, notably the decrease in amplitude, could allow a diagnosis during the course of surgery making it possible to diagnose lesions of the nerve and guide the surgeon in his surgical decisions, thus avoiding the risk of bilateral recurrent paralysis. It could also enable the surgeon to give a prognosis for functional recovery.

status: Completed

study_completion_date_type: Actual

study_type: Observational

time_perspective: Prospective

enrollment_type: Actual

lead_sponsor: Centre Hospitalier Universitaire, Amiens

location_facility:
CHU Nimes
CHU Amiens

intervention_type: Device

lead_sponsor_type: academique

status_simplified: Completed


title: Tolerance and Efficiency of Paracetamol bu Subcutaneous Releasing in Patients Hospitalized Into Palliative Care

acronym: TEPASC

summary: The purpose of this study is to evaluate the tolerance and the efficiency of subcutaneous administration of Paracetamol for patients in palliative care.

ReferenceType: derived

ReferenceCitation: Leheup BF, Ducousso S, Picard S, Alluin R, Goetz C. Subcutaneous administration of paracetamol-Good local tolerability in palliative care patients: An observational study. Palliat Med. 2018 Jul;32(7):1216-1221. doi: 10.1177/0269216318772472. Epub 2018 May 8.

name: Palliative Care Department, Metz-Thionville Regional Hospital, Metz, France

family: Leheup

full_name: Benoît F Leheup

given: Benoît F

sequence: first

family: Ducousso

full_name: Stéphanie Ducousso

given: Stéphanie

sequence: additional

name: Palliative Care Unit, Diaconesses Croix Saint Simon Hospital, Paris, France

family: Picard

full_name: Stéphane Picard

given: Stéphane

family: Alluin

full_name: Raphaël Alluin

given: Raphaël

name: Clinical Research Support Unit, Metz-Thionville Regional Hospital, Metz, France

family: Goetz

full_name: Christophe Goetz

given: Christophe

bso_classification: Medical research

datasource: user

genre: journal-article

genre_raw: journal-article

journal_name: Palliative Medicine

publisher: SAGE Publications

publisher_dissemination: SAGE Publications

publisher_group: SAGE Publications

publisher_normalized: SAGE Publications

title: Subcutaneous administration of paracetamol—Good local tolerability in palliative care patients: An observational study

ipd_sharing: No

lead_sponsor: Centre Hospitalier Régional Metz-Thionville

location_facility:
GH Diaconesses Croix Saint Simon
CHR Metz-Thionville


title: Retrograde Approach in Ambulatory Practice

acronym: RAAR

summary:
Obliterative arterial disease of the lower limbs affects 200 million people worldwide, including approximately 40 million in Europe. This disease is associated with a significant increase in morbidity and mortality.

The most common clinical symptomatology is difficulty walking (intermittent claudication). Less frequent but more severe, critical ischemia includes rest pain requiring analgesics, and trophic disorders (ulcers, gangrene), which may lead to amputation. The Rutherford classification groups the different clinical forms of this pathology. The classic risk factors of cardiovascular pathologies, such as age, smoking, hypertension, diabetes and hypercholesterolemia, are closely linked to Obliterative arterial disease of the lower limbs. Over the past 20 years, the interventional management of this condition has undergone a paradigm shift. The rise of endovascular surgery has broadened the range of therapeutic possibilities, while reducing the impact on patients. Advances in equipment and imaging quality have made it possible to treat increasingly complex lesions, allowing this type of technique to be offered to patients initially treated with conventional surgery (Trans-Atlantic Inter-Society Consensus (TASC) C and D). Unfortunately, for long recanalizations and calcified lesions, the crossing of the lesion and its re-entry into the true arterial lumen is a failure in 25% of cases. It is with this in mind that retrograde puncture and the associated SAFARI (Subintimal Arterial Flossing with Anterograde-retrograde Intervention) technique were developed. In case of failure to cross the lesion by anterograde, intraluminal or subintimal, a retrograde puncture downstream, echo or radio guided, is performed. The vessels most often punctured are the popliteal artery or the leg axes. Recanalization of the lesion is done by retrograde approach. The guidewire introduced distally is recovered in the introducer through which the first recanalization attempt was made. The procedure is then performed in the classical way using the anterograde approach. At the end of the procedure, hemostasis of the puncture site is obtained by prolonged inflation of a balloon or the placement of a covered stent. Initially reserved for critically ischemic patients (Rutherford 4-6), this technique tends to be extended to claudicant patients (Rutherford 2-3). Zhuang et al have recently demonstrated the efficacy and safety of this technique in a large cohort of patients.

In parallel with the evolution of revascularization techniques, the evolution of care pathways has given ambulatory care a prominent place. Since January 2020, in the vascular surgery department of GHPSJ, peripheral angioplasties are mostly performed on an outpatient basis. The patients treated are classified as Rutherford 2 to 5 in most cases. No adverse events related to this management have been reported. To date, no study evaluating the feasibility and safety of retrograde punctures in the outpatient setting has been performed.

study_start_date_type: Actual

status: Recruiting

study_completion_date_type: Anticipated

time_perspective: Cross-Sectional

enrollment_type: Anticipated

ReferenceType: background

ReferenceCitation: Aboyans V, Ricco JB, Bartelink MEL, Björck M, Brodmann M, Cohnert T, Collet JP, Czerny M, De Carlo M, Debus S, Espinola-Klein C, Kahan T, Kownator S, Mazzolai L, Naylor AR, Roffi M, Röther J, Sprynger M, Tendera M, Tepe G, Venermo M, Vlachopoulos C, Desormais I; ESC Scientific Document Group. 2017 ESC Guidelines on the Diagnosis and Treatment of Peripheral Arterial Diseases, in collaboration with the European Society for Vascular Surgery (ESVS): Document covering atherosclerotic disease of extracranial carotid and vertebral, mesenteric, renal, upper and lower extremity arteriesEndorsed by: the European Stroke Organization (ESO)The Task Force for the Diagnosis and Treatment of Peripheral Arterial Diseases of the European Society of Cardiology (ESC) and of the European Society for Vascular Surgery (ESVS). Eur Heart J. 2018 Mar 1;39(9):763-816. doi: 10.1093/eurheartj/ehx095.

ReferenceCitation: Fowkes FG, Rudan D, Rudan I, Aboyans V, Denenberg JO, McDermott MM, Norman PE, Sampson UK, Williams LJ, Mensah GA, Criqui MH. Comparison of global estimates of prevalence and risk factors for peripheral artery disease in 2000 and 2010: a systematic review and analysis. Lancet. 2013 Oct 19;382(9901):1329-40. doi: 10.1016/S0140-6736(13)61249-0. Epub 2013 Aug 1. Review.

ReferenceCitation: Sampson UK, Fowkes FG, McDermott MM, Criqui MH, Aboyans V, Norman PE, Forouzanfar MH, Naghavi M, Song Y, Harrell FE Jr, Denenberg JO, Mensah GA, Ezzati M, Murray C. Global and regional burden of death and disability from peripheral artery disease: 21 world regions, 1990 to 2010. Glob Heart. 2014 Mar;9(1):145-158.e21. doi: 10.1016/j.gheart.2013.12.008. Review.

lead_sponsor: Groupe Hospitalier Paris Saint Joseph

location_facility: Centre Hospitalier Universitaire de Brest

status_simplified: Ongoing


title: Evaluation du Test " Sofia SARS Antigen FIA Assay " Dans le Cadre du dépistage de la COVID-19

acronym: ESADEC

summary: Evaluating the performance of the Sofia SARS Antigen FIA

ipd_sharing: Yes

ipd_sharing_description: All collected data that underlie results in a publication

lead_sponsor: University Hospital, Brest

location_facility:
Centre de dépistage - CHRU BREST
CHRU de brest


title: Modifications in Retinal Microvascularization With OCT- Angiography in Patients With First-line Colorectal Cancer, Treated With Targeted Anti-angiogenic Therapy.

acronym: VOCANGIO

summary: Retinal microvascularization can provide important informations to systemic vascular phenomena. The non-invasive quantitative description of the retinal vascularization is now possible by performing OCT-angiography and their image analysis software (vascular density and retinal perfusion). Systemic microvacular changes during the establishment of oncological treatment by targeted antiangiogenic therapy are little described in the literature. The objective of this pilot study is to describe the evolution of the retinal vascular density of patients with antiangiogenic drugs. In addition, the evolution of the retinal vascular density of patients on antiangiogenic drugs will study as a function of the response to the treatment and the toxicity of these treatments.

study_type: Interventional

primary_purpose: Other

lead_sponsor: Centre Georges Francois Leclerc

location_facility:
Centre Georges François Leclerc
CHU de Dijon

intervention_type: Other

lead_sponsor_type: industriel


title: Effects of Yoga in the Rehabilitation of Stroke Patients With Chronic Sequelea: A Randomized Controlled Trial.

summary:
Stroke is a major health problem and can cause long-term disability. Among these sequelae, there are balance and mobility disorders, but also a higher rate of anxiety or depression disorders. This impairments impact activity of daily living, and social reintegration. That why the investigators need to explore options for long-term sustainable interventions that which takes into account the patient as a whole. In particular, regular physical activity is recommended, but it must be adaptable to the patient's impairments. Teaching yoga may be an interesting option. Indeed, yoga is a mind-body practice which become increasingly widespread in the world. Recent studies highlight positive effect of yoga for this population. However, the levels of evidence are limited, and new studies are needed.

Primary objective of the study is to demonstrate the non-inferiority of a therapeutic yoga program, compared to a conventional physical activity program, to improve balance of patients with chronic stroke sequelae.

Secondary objectives are to demonstrate the non-inferiority of the therapeutic yoga program in improving muscle strength and functional mobility, as well as its superiority in improving anxiety, depression, social reintegration and adherence to treatment.

study_start_date_type: Anticipated

status: Not yet recruiting

design_allocation: Randomized

primary_purpose: Treatment

ReferenceCitation: Green E, Huynh A, Broussard L, Zunker B, Matthews J, Hilton CL, Aranha K. Systematic Review of Yoga and Balance: Effect on Adults With Neuromuscular Impairment. Am J Occup Ther. 2019 Jan/Feb;73(1):7301205150p1-7301205150p11. doi: 10.5014/ajot.2019.028944.

ReferenceCitation: Thayabaranathan T, Andrew NE, Immink MA, Hillier S, Stevens P, Stolwyk R, Kilkenny M, Cadilhac DA. Determining the potential benefits of yoga in chronic stroke care: a systematic review and meta-analysis. Top Stroke Rehabil. 2017 May;24(4):279-287. doi: 10.1080/10749357.2016.1277481. Epub 2017 Jan 19. Review.

ReferenceCitation: Edwards MK, Loprinzi PD. Comparative effects of meditation and exercise on physical and psychosocial health outcomes: a review of randomized controlled trials. Postgrad Med. 2018 Mar;130(2):222-228. doi: 10.1080/00325481.2018.1409049. Epub 2017 Nov 27. Review.

ipd_sharing_description: The data collected will be anonymized, computerized and stored by Maxime GILLIAUX. Only the investigators will have access to the anonymized data in order to carry out the statistical work of this research.

lead_sponsor: Hopital La Musse

location_facility:
Hopital La Musse
City Hall of Corneville sur Risle


title: Families Expectations and Hope Raised by an Evaluation of Consciousness in Patients With an Unresponsive Wakefulness Syndrome

acronym: REVE

summary:
Progress in resuscitation has increased the chances of survival after anoxic or traumatic brain injury. More and more patients with severe cerebral damages are resuscitated but upon awakening from coma, some patients remain in a state which cannot be qualified as conscious and is now known as an unresponsive wakefulness syndrome (UWS; formerly known as vegetative state). This condition can be transitory and evolve towards recovery, or remain chronic and lasting for years.

To improve the diagnosis of patients with disorders of consciousness, recent advances in brain imaging have led to the development of new methods of detecting awareness. In the absence of overt behavioral responses from these patients, imaging-based diagnostic methods have been first used to assess whether some cerebral areas were preserved in UWS patients and showed an activation of the primary sensory cortices in some UWS patients, whether it occurs at the auditory, visual or somatosensory level. Unavoidable technical and ethical issues are raised for clinicians before responding to such requests:

Is it technically possible to generalize neuroimaging protocols to all healthcare institutions?
Is it ethically acceptable to propose neuroimaging protocols without an accurate estimation of their psychological impact on families and caregivers?

The present study aims to understand and anticipate the technical and ethical issues related to an evaluation of consciousness with functional neuroimaging. How the evaluation of awareness in a patient affects the caregivers and family members will be investigated. By using qualitative research hopes and expectations will be clarified through the experiences of families, clinicians and nurses faced to this situation.

Will be included in this research professional caregivers and persons closely related to UWS patients:

Family members or close circle visiting the patients on a regular basis
Referring clinicians
Nurses in charge of the patients' care

This prospective study uses qualitative, interview-based, research. Two key-moments are explored in succession to examine the impact of a neuroimaging evaluation of consciousness in institutionalized UWS patients:

interviews of professional caregivers and families about their hopes concerning the evaluation of consciousness of UWS patients,
interviews of professional caregivers and families about the impact of evaluating consciousness on their beliefs

lead_sponsor: Centre Hospitalier Universitaire de Besancon

location_facility: Etablissement de rééducation fonctionnelle Bretégnier

location_facility: Etablissement de rééducation fonctionnelle Les Salins de Bregille


title: A Randomized Control Trial of Bilateral Lateral OFC rTMS in Obsessive Compulsive Disorder

summary: According to the literature the lateral part of the Orbito Frontal Cortex (lOFC) is a relevant bilateral target for repetitive Trans-cranial Magnetic Stimulation (rTMS) in Obsessive Compulsive Disorder (OCD). Both hemispheres are concerned in terms of target.

lead_sponsor: Centre Hospitalier Henri Laborit

location_facility: Sorbonne University, Pitié-Salpêtrière Hospital


title: Genetic Study of Varicose Disease by Sequencing Exome

summary: The existence of a family factor in the genesis of varicose veins is certain, but few studies have addressed reliably instead of the genetic factor in clinical and molecular level. The investigator initiated an original study to identify one or more genetic abnormalities predisposing to varicose disease, based on a combined approach of genetic linkage and of exome sequencing. The clinical research phase is an essential prerequisite to the identification of genetic mutations; it is to identify large affected families and ensure an extremely rigorous and accurate phenotyping of individuals over several generations. A first clinical work has identified and / or phenotype 8 families with a genetically informative family suggesting autosomal dominant inheritance. Linkage analysis suggested several candidate chromosomal regions without allowing the identification of a gene. This project aims to resume and expand the Family clinical investigations and apply the techniques of genome analysis points, including exome sequencing on the most informative families to identify the genes and mechanisms responsible of this disease and improve the prevention and the treatment of varicose veins.

ipd_sharing: Undecided

lead_sponsor: Nantes University Hospital

location_facility:
La Roche sur Yon Hospital
Nantes Univesrity Hospital


title: Immunomonitoring of Breast Cancer Patients During Systemic Treatment

acronym: IMMUNE CAPTURE

summary: This study aims to constitute a most complete biological collection for patients treated for localized or metastatic breast cancer (in different cohorts depending on the type of systemic treatment received), in order to describe the basal immune response of patients treated for a breast cancer according to the stage of the disease, but above all to study how the different systemic treatments used in the management of breast cancer modulate this immune response.

location_facility:
CHRU Jean Minjoz
Centre Georges Francois Leclerc


title: MATRIX - "Modeling Macrophages Activation Pattern in X-linked Adrenoleukodystrophy and Metachromatic Leukodystrophy"

acronym: MATRIX

summary:
This study is a national, non-randomized, open-label, multi-site with minimal risk study in adult with adrenomyeloneuropathy (AMN) and childhood subjects with cerebral ALD (cALD) or late-infantile metachromatic leukodystrophy (LI-MLD) (≤17 years). 28 subjects will be enrolled with one blood sample collection during one of their medical follow-up visit.

This trial will evaluate the role of innate immunity to influence disease progression in X-ALD and MLD, and if the mutations related to these leukodystrophies result in a specific immune response leading to the pathogenesis.

ReferenceCitation: Miron VE, Boyd A, Zhao JW, Yuen TJ, Ruckh JM, Shadrach JL, van Wijngaarden P, Wagers AJ, Williams A, Franklin RJM, Ffrench-Constant C. M2 microglia and macrophages drive oligodendrocyte differentiation during CNS remyelination. Nat Neurosci. 2013 Sep;16(9):1211-1218. doi: 10.1038/nn.3469. Epub 2013 Jul 21.

ReferenceCitation: Weinhofer I, Zierfuss B, Hametner S, Wagner M, Popitsch N, Machacek C, Bartolini B, Zlabinger G, Ohradanova-Repic A, Stockinger H, Köhler W, Höftberger R, Regelsberger G, Forss-Petter S, Lassmann H, Berger J. Impaired plasticity of macrophages in X-linked adrenoleukodystrophy. Brain. 2018 Aug 1;141(8):2329-2342. doi: 10.1093/brain/awy127.

ReferenceCitation: Berger J, Forss-Petter S, Eichler FS. Pathophysiology of X-linked adrenoleukodystrophy. Biochimie. 2014 Mar;98:135-42. doi: 10.1016/j.biochi.2013.11.023. Epub 2013 Dec 4. Review.

ReferenceCitation: Gieselmann V, Krägeloh-Mann I. Metachromatic leukodystrophy--an update. Neuropediatrics. 2010 Feb;41(1):1-6. doi: 10.1055/s-0030-1253412. Epub 2010 Jun 22. Review.

location_facility:
AP-HP Hôpital Bicêtre
AP-HP Hôpital La Pitié Salpêtrière

intervention_type: Diagnostic Test


title: Study of the ISotopic Repartition of cOpper in Head and Neck TumOral and lymPhomatous pathologiEs

acronym: ISOTOPE

summary:
The distribution of stable (non-radioactive) isotopes in living organisms is increasingly studied, in particular the zinc (Zn), copper (Cu) and iron (Fe), not only in primitive organisms, but also in mammals.

The scientific community shows a growing interest in the study of the isotopic distribution of Cu in humans: this distribution can vary according to gender or nutrition. Concerning pathology, the isotopic distribution of Cu seems interesting in Wilson's disease or in cirrhosis.

Additionally, a promising area of study focuses on the role of Cu in cancerous tumors, neoangiogenesis, the mechanisms of free radicals reduction and signaling pathways.

Head and neck cancers are sensitive to platinum salts. Links between platinum and Cu are important: platinum penetrates into the cell through a Cu receptor, it interacts with the regulation mechanisms of Cu and platinum.

Preliminary studies suggest a variation of the measurable isotopic distribution of Zn in patients with breast tumor and of Cu in patients presenting breast as well as colorectal tumors.

The Larner et al. study suggest a promising role of Zn in breast cancer, indeed, results highlight a variation of distribution of Zn in 10 breast tumors. Concerning the study of Télouk et al. on 8 patients presenting colorectal tumors and 20 patients presenting breast tumors, results are in favor of an increase of mortality when Cu 65 is decreased in the serum and the isotopic modifications happen earlier than usual modifications of biochemical tumor markers such as: carbohydrate antigen (CA) 19.9, Carcinoma Antigen (CA) 15.3, Carcinoembryonic antigen (CEA).

Currently, there is no information about the distribution of the stable isotopes of Cu in head and neck tumors.

The objective of the study is to determine if the distribution of 65Cu / 63Cu is modified in tumoral tissues compared to healthy tissues. The isotopic distribution of the Cu in 2 tumor types, head and neck tumors and lymphomas, will be also investigated in order to determine if this distribution is specific of a tumor type or not.

In case of positivity of this variation, the prognostic interest of these parameters will be evaluated.

status: Active, not recruiting

lead_sponsor: Lille Catholic University

location_facility:
ENS Lyon
GHICL

intervention_type: Procedure


title: Motor Asymmetry in Progressive Multiple Sclerosis Patients

acronym: MAP-MS

summary:
Project Rational

A better understanding of the causes of physical disability is an important unmet need in progressive Multiple Sclerosis patients. Progressive Multiple Sclerosis patients most often present a worsening pyramidal syndrome of lower and, to a lesser extent, upper limbs (Lublin et al., 2014) suggesting a strong corticospinal tract involvement. The systematic high resolution Magnetic Resonance Imaging exploration of lesions location and severity, as well as extra-lesional tissue, on pan-medullar and encephalic motor tracts offers the opportunity to better understand the pathological mechanism associated with motor impairment.

Scientific aims

This project will follow a twofold approach. First, the investigators will consider an "inter-patient" approach where independent and absolute Magnetic Resonance metrics for each limb will be related to disability. Second, the investigators will consider an "intra-patient" approach (i.e. comparing differences of Magnetic Resonance metric and of clinical score from the left and the right side in the same patient). For this purpose, progressive Multiple Sclerosis patients with asymmetric motor impairment will be studied. Confronting clinical and Magnetic Resonance Imaging metric value asymmetries indeed offers the unique opportunity to free oneself from many confounding factors such as genetics, age, duration of disease evolution, acquisition bias, etc. These two approaches will allow us to precisely study the impact of local factors such as Multiple Sclerosis lesions located on motor tracts on motor disability.

Methodology

The investigators propose an observational multicenter cross-sectional and prognostic study. This study will involve two French centers (Rennes, Marseille) and will include a total of 40 progressive Multiple Sclerosis patients with an asymmetrical motor deficit. Twenty sex and age matched controls will be needed to calibrate quantitative Magnetic Resonance imaging (magnetization transfer ratio). Encephalic and pan medullar structural and quantitative Magnetic Resonance images will be acquired at inclusion and clinical follow-up examinations will be performed at inclusion and 24 months. Detailed motor evaluation "per limb" will be performed, including the motor American Society Injury. Association sub-score and upper and lower limbs muscle strength measurements using a dynamometer.

lead_sponsor: Rennes University Hospital

location_facility:
CHU de Rennes - Hôpital Pontchaillou
Hôpital de la Timone, AP-HM

intervention_type: Radiation


title: FSH-R (Follicle-stimulating Hormone Receptor ): Diagnostic Application for Localized Tumors in Cancerology

acronym: FRACTal

summary:
FRACTal study is the first exploration of detection of FSHR as a blood biomarker for the diagnosis of cancer.

A first cohort will explore several common (e.g. breast, prostate) or rare (e.g. uveal melanoma) cancers, that are frequently treated at Institut Curie. This first cohort will include n=10 patients per histological type except for breast cancer (n=50). 100 patients are expected in this cohort.

A second cohort will explore the more promising histological type (if any) in term of incidence of detection. 100 patients are expected for this second cohort.

status: Terminated

design_allocation: Non-Randomized

lead_sponsor: Institut Curie

location_facility:
Centre René Huguenin
Institut Curie

status_simplified: Unknown


title: Cognitive Inhibition Impairment and Suicide Attempt in Elderly: Eye Tracking Characterization and Impact of Psychosocial Interactions

acronym: OBSUIVAL

summary: The study aims to determine the correlation between the cognitive inhibition impairment and the history of suicide attempt in elderly depressed patients.

status: Unknown status

primary_purpose: Screening

location_facility:
CHS Bavilliers
CHU Besancon

intervention_type: Behavioral


summary:
This data base has been set in order to gather oncogeriatric information from elderly patients with pancreatic cancer who underwent an oncogeriatric evaluation.

ONCOGEPAN database gathers data from deux institutions (Institut Paoli-Calmettes and Assistance Publique des Hôpitaux de Marseille) involved in Marseille SIRIC (Integrated Cancer Research Site).

lead_sponsor: Institut Paoli-Calmettes


type: EudraCT Number

title: Predictive Factors of ANTI-TNF Response in Luminal Crohn's Disease Complicated by Abscess A Multicenter Prospective, Observational Cohort Study

acronym: MICA

summary: To identify predictive factors of adalimumab (anti TNF) response in patients with luminal Crohn's disease complicated by intra-abdominal and/or pelvic abscess after complete resolution of infection.

lead_sponsor: Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives

location_facility:
Aphp St Louis
Beaujon Hospital


type: Other Identifier

title: Evaluation and Support Care Process Within the Care Pathway of Heart Failure Patients

acronym: FIL-EAS

summary:
Acute heart failure current management turns out to be a relative failure considering its elevated economical and human costs and the poor results obtained in terms of disease outcome. Indeed this disease remains associated with a high rate of early re-hospitalizations and low adherence to therapeutic recommended settings and doses. Moreover, extra cardiological follow-up such as in social, geriatric or vaccination fields remain low compared to real needs.

Current recommendations incite health professionals to better define care pathways and to rationalize resources. Guidelines toward creation of hospitalization alternatives or limitation of time spent in hospital are given. In the same time, lack of cardiologic care management within heart failure patient care pathway is associated to poor prognosis and medical desertification as well as resource concentration on important health centers exacerbate this phenomenon. Innovative projects are then needed to improve patient care pathways, to open up areas without specialized health professionals and to rationalize care management by encouraging communication and skill exchange between hospitals and private practices.

FIL-EAS ic projet aims to compare a conventional care pathway in hospital with a follow up defined according to High Authority of Health recommendations to an organized care pathway favoring a short hospitalization (maximum of 4 working days) with early transition, when possible, to a medical and paramedical home care management with an approximately 10 day long combined follow up between hospital and private practices. This second care pathway should help to optimize therapeutics in home living conditions.

primary_purpose: Health Services Research

lead_sponsor: Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer

location_facility: Centre Hospitalier Intercommunal Toulon La Seyne sur Mer


title: Survival After Blood Transfusion in the French Administrative Regions of Burgundy and Franche-Comté

acronym: STeF-BFC

summary:
Red blood cell transfusion (RBC) is the main symptomatic treatment for severe anemia. RBC transfusion has proven its efficacy regarding mortality and morbidity, but it is not without side effects. The infectious side effects of transfusion are largely considered under control, non-infectious side effects are taking center stage. Seeking explanations for the beneficial and deleterious effects of RBC transfusions is necessary to ensure the safe and optimal use of this precious resource.

The investigators aim to study the impact of donor and RBC characteristics on patient survival.

time_perspective: Retrospective

ReferenceType: result

ReferenceCitation: Desmarets M, Bardiaux L, Benzenine E, Dussaucy A, Binda D, Tiberghien P, Quantin C, Monnet E. Effect of storage time and donor sex of transfused red blood cells on 1-year survival in patients undergoing cardiac surgery: an observational study. Transfusion. 2016 May;56(5):1213-22. doi: 10.1111/trf.13537. Epub 2016 Mar 2.

name: Centre d'Investigation Clinique, INSERM CIC 1431; University Hospital of Besançon; Besançon France

family: Desmarets

full_name: Maxime Desmarets

given: Maxime

name: Etablissement Français du Sang (EFS) Pyrénées Méditerranée; Toulouse, France

family: Bardiaux

full_name: Laurent Bardiaux

given: Laurent

name: Service de Biostatistiques et Informatique Médicale (DIM), University Hospital of Dijon; Dijon, France

family: Benzenine

full_name: Eric Benzenine

given: Eric

name: Département d'Information Médicale; University Hospital of Besançon

family: Dussaucy

full_name: Alain Dussaucy

given: Alain

family: Binda

full_name: Delphine Binda

given: Delphine

name: UMR 1098, INSERM, Université de Franche-Comté, Etablissement Français du Sang; Besançon, France

family: Tiberghien

full_name: Pierre Tiberghien

given: Pierre

name: Centre d'Investigation Clinique, INSERM CIC 1432, University Hospital of Dijon

name: UMR 1181, Biostatistiques, biomathématiques, pharmacoépidémiologie et maladies infectieuses (BP2PHI), INSERM Université de Bourgogne; Dijon France

family: Quantin

full_name: Catherine Quantin

given: Catherine

name: EA 4266, Agents Pathogènes et Inflammation, Université de Franche-Comté; Besançon France.

family: Monnet

full_name: Elisabeth Monnet

given: Elisabeth

journal_name: Transfusion

publisher: Wiley

publisher_dissemination: Wiley

publisher_group: Wiley

publisher_normalized: Wiley

location_facility: Centre d'Investigation Clinique, CHU de Besançon

location_facility: Département d'information Médicale, CHU Dijon


title: Study of the Inappropriate Secretion of FGF23 in Patients Followed in Hospital in a Context of Hypophosphatemia

acronym: IFEH

summary:
The discovery of FGF23, the missing link in the long researched and finally found phosphate metabolism, marked a turning point in the understanding and physiopathology of specific hypophosphatemia. By inhibiting the renal reabsorption of phosphate and the production of calcitriol, FGF23 behaves like a hypophosphatemia hormone.

Hypersecretion of FGF23 can occur in the case of genetic abnormalities (X-linked hypophosphatemic vitamin-resistant rickets, recessive or dominant hypophosphatemic rickets, McCune-Albright syndrome ...) or acquired abnormalities (oncogenic osteomalacia). Oncogenic osteomalacia can be induced by hyperproduction of FGF23 by benign tumours of mesenchymal origin. But more recently, several cases of malignant tumours secreting FGF23 have also been described (prostate, colon, breast, ovarian and lung cancers, pulmonary carcinoma, etc.)

ReferenceCitation: Suvannasankha A, Tompkins DR, Edwards DF, Petyaykina KV, Crean CD, Fournier PG, Parker JM, Sandusky GE, Ichikawa S, Imel EA, Chirgwin JM. FGF23 is elevated in multiple myeloma and increases heparanase expression by tumor cells. Oncotarget. 2015 Aug 14;6(23):19647-60.

ReferenceCitation: Imel EA, Biggin A, Schindeler A, Munns CF. FGF23, Hypophosphatemia, and Emerging Treatments. JBMR Plus. 2019 May 13;3(8):e10190. doi: 10.1002/jbm4.10190. eCollection 2019 Aug. Review.

ReferenceCitation: Endo I, Fukumoto S, Ozono K, Namba N, Inoue D, Okazaki R, Yamauchi M, Sugimoto T, Minagawa M, Michigami T, Nagai M, Matsumoto T. Nationwide survey of fibroblast growth factor 23 (FGF23)-related hypophosphatemic diseases in Japan: prevalence, biochemical data and treatment. Endocr J. 2015;62(9):811-6. doi: 10.1507/endocrj.EJ15-0275. Epub 2015 Jul 1.

lead_sponsor: University Hospital, Clermont-Ferrand

location_facility:
Centre Jean Perrin
Chu Clermont Ferrand


title: Etude Prospective, Multicentrique, Non contrôlée, Non randomisée, Ouverte Pour l'évaluation de la Fixation Osseuse d'Une Cupule hémisphérique, le Mpact® Double Mobilité

summary: This study aims to evaluate long term fixation of the Mpact Double Mobility cup trough IMAGIKA technology.

lead_sponsor: Medacta International SA

location_facility:
Orthéo - Espace Fauriel
Clinique Générale


title: Predictive Response to Chemotherapy (FOLFOX or FOLFIRI) by ex Vivo Culture 3D Technique in Metastatic Colorectal Cancer: a Preliminary Study

summary: Prospective, open labelled, multicenter trial to evaluate the feasibility of ex vivo culture 3D (chemogram obtaining) on biopsies in order to estimate the predictive value of this technique for treatment response in patients treated by two different chemotherapies (FOLFOX or FOLFIRI) for colorectal cancer.

location_facility:
Institut Curie
Hôpital Lariboisière


title: ERASE VITILIGO Early Repigmentation Approach for Stopping the Evolution of VITILIGO Prospective Multicentric Interventional Study With Blinded Evaluation

acronym: ERASE

summary:
Vitiligo affects 1 to 2% of worldwide population and has a demonstrated impact on the quality of life.

Optimal treatment of vitiligo requires to target the auto-immune inflammatory response (to halt the depigmentation process), in particular T cells, but also to induce the differentiation of melanocyte stem cells (to induce repigmentation). Ultimately, the treatment should also prevent the recurrences of depigmentation. Indeed, when repigmentation is achieved, 40 to 50% of lesions reoccur within one year, suggesting that skin resident memory T cell clones remain in repigmented vitiligo skin and might explain these recurrences.

The investigators hypothesize that a very early intervention could prevent the accumulation of the skin resident memory T cells in vitiligo lesions. Moreover, they also think that such an early treatment would also optimize the repigmentation process, even in traditionally resistant areas, as some remaining pre-melanocytes and maybe even some melanocytes, could proliferate and recolonize the epidermis.

Objectives : to compare the resident memory T-cell infiltrate in perilesional vitiligo skin after 6 months of treatment with OMP and UVB, between three groups of patients suffering from non-segmental vitiligo Interventions The 3 groups will receive a combination of narrowband UVB (Nb-UVB) 3 times a week and oral mini pulses of systemic steroids (5 mg of d medrol 16mg twice a week) for 24 weeks.

Three visits will be done (inclusion, Week 12 and 24) A skin biopsy will be done on lesional and peri-lesional area at baseline. Another skin biopsy will be taken after 24 weeks but only in perilesional area. A blood sample for assessing the circulating memory T cells and for checking the tolerance will be performed at baseline, then at W12 and W24.

The combination of narrowband UVB and oral minipulse of steroids are considered as a standard care of active vitiligo patients. Clinical assessment (including blood pressure) and hemogram, liver enzymes, urea, creatinemia, glycemia, natremia and kaliema will be assessed at baseline, 3 and 6 months.

Main criteria of evaluation:

The target lesion will be chosen before any treatment. The minimal size will be 2cm². Considering that skin on the face usually responds very well whilst that of hands and feet respond poorly, to avoid potential bias due to the location of treatment, these locations won't be taken as target lesions. In any cases, no biopsy will be taken on the face or in the folds.

lead_sponsor: Centre Hospitalier Universitaire de Nice

location_facility:
CHU de Nice
CHU Bordeaux


title: Contribution of PET Scans for the Preoperative Assessment of Symptomatic Endometriosis Lesions: TEP-ENDORUN

acronym: TEP-ENDORUN

summary:
Endometriosis is an inflammatory condition that is often treated by surgery. MRI and ultrasound are used for the preoperative morphological assessment. Currently, only surgery allows the exhaustive and qualitative diagnosis of lesions.

The PET scan, fixing in certain inflammatory pathologies and in certain cases of endometriosis, could refine this assessment by evaluating the location of the lesions.

primary_purpose: Diagnostic

lead_sponsor: Centre Hospitalier Universitaire de la Réunion

location_facility: Centre Hospitalier Universitaire Réunion

intervention_type: Drug


title: Association Between Preoperative Fasting, Intraoperative Glycemic Control, and Hospital Lenght of Stay in Children Younger Than 24 Months of Age Undergoing Scheduled Conventional Inpatient Surgery

acronym: GLYNEMCaen

summary: In 2018, the main societies of anesthesia (European Society Anaesthesiology, European Society Pediatric Anesthesia, and Association des Anesthésistes Réanimateurs Pédiatriques d'Expression Française) changed the current recommendations for preoperative fasting time in children, reducing the time to last intake of clear liquids from two to one hour before anesthetic induction. Prolonged fasting may have a deleterious impact on blood glucose homeostasis. The consequences of intraoperative hypoglycemia in children can be serious in the short term, but also in the long term. The objective of multicenter prospective, observational cohort study is to investigate- in children younger than 24 months of age undergoing scheduled conventional inpatient surgery- a correlation between the duration of preoperative fasting, glycemic intraoperative homeostasis and the criteria of enhanced recovery after surgery, which are the hospital length of stay (main outcome), postoperative pain and postoperative nausea-vomiting (secondary outcomes). By identifying non-adherence to fasting rules as one of the causes of prolonged hospitalization, this study will highlight the need to develop effective strategies to promote adherence to fasting rules in pediatric surgery and minimize the potential deleterious impact on intraoperative glycemic control.

lead_sponsor: University Hospital, Caen

location_facility:
CHU Caen Normandie
Hôpital Necker Enfants Malades


title: Circulating Tumor DNA in Primary Mediastinal Large B-cell Lymphoma (PMBL)

acronym: CAMIL

summary: The purpose of this study is to compare the predictive value in terms of specificity of circulating tumor DNA (ctDNA) and positron emission computed tomography (PET-CT) after 2 cycles of chemotherapy (C2), on the probability of obtaining a metabolic complete response after 4 cycles of induction chemotherapy (C4) in patients with primary mediastinal large B cell lymphoma (PMBL) receiving standard R-CHOP14 or R-ACVBP.

lead_sponsor: Centre Henri Becquerel

location_facility:
Centre Henri Becquerel
Centre Hospitalier Lyon Sud


title: Perception of the Doctor/Patient Relationship, Disease and Treatment Among Physicians and Their Patients Treated With Systemic Therapy for Hepatocellular Carcinoma

summary:
atients with cancer face difficult choices that require balancing competing priorities such as survival, functional capacity and symptom relief. Most patients with advanced cancer (>80%) expect their sensitive discussions with physicians about prognosis and treatment choices, in order to be involved in the decision making process. Nevertheless, this kind of discussion is frequently lacking. Consequently, patients often have a biased view of their own prognosis such as an underestimation of disease severity, or unrealistic expectations for cure.

Patients with advanced hepatocellular carcinoma (HCC) may be treated with systemic therapies which may prolong survival, but are not curative. Patients with advanced HCC often report expectations for survival and treatment-related side-effects that differ from their treating physician. Accordingly, communication on prognostic and treatment choices is essential to obtain an accurate understanding of the disease that allows patients to make informed decisions. To the best of our knowledge, a thorough evaluation of the physician-patient communication quality has never been performed in advanced HCC patients.

The aim of our study, is to assess the perception of the expected prognosis, the treatment side-effects; by the patient and by his investigator during the first consultation before the initiation

ReferenceCitation: Loh KP, Mohile SG, Lund JL, Epstein R, Lei L, Culakova E, McHugh C, Wells M, Gilmore N, Mohamed MR, Kamen C, Aarne V, Conlin A, Bearden J 3rd, Onitilo A, Wittink M, Dale W, Hurria A, Duberstein P. Beliefs About Advanced Cancer Curability in Older Patients, Their Caregivers, and Oncologists. Oncologist. 2019 Jun;24(6):e292-e302. doi: 10.1634/theoncologist.2018-0890. Epub 2019 Apr 23.

ReferenceCitation: Yennurajalingam S, Rodrigues LF, Shamieh O, Tricou C, Filbet M, Naing K, Ramaswamy A, Perez-Cruz PE, Bautista MJS, Bunge S, Muckaden MA, Sewram V, Fakrooden S, Noguera-Tejedor A, Rao SS, Liu D, Park M, Williams JL, Lu Z, Cantu H, Hui D, Reddy SK, Bruera E. Perception of Curability Among Advanced Cancer Patients: An International Collaborative Study. Oncologist. 2018 Apr;23(4):501-506. doi: 10.1634/theoncologist.2017-0264. Epub 2017 Nov 20.

lead_sponsor: Assistance Publique - Hôpitaux de Paris

location_facility:
Assistance Publique - Hôpitaux de Paris
Hôpital Avicenne


title: Effects of Training on a Rower Assisted by Electrostimulation of Lower Limbs in Paraplegic Patients (FES-ROW)

acronym: FES-ROW

summary: The main objective of this project is to measure the increase in aerobic physical and metabolic capacities with a 6-month training on a rower assisted by electrostimulation of lower limbs in a population of adults with traumatic paraplegia.

primary_purpose: Prevention

ReferenceCitation: Wheeler GD, Andrews B, Lederer R, Davoodi R, Natho K, Weiss C, Jeon J, Bhambhani Y, Steadward RD. Functional electric stimulation-assisted rowing: Increasing cardiovascular fitness through functional electric stimulation rowing training in persons with spinal cord injury. Arch Phys Med Rehabil. 2002 Aug;83(8):1093-9.

ReferenceCitation: Popovic-Maneski L, Aleksic A, Metani A, Bergeron V, Cobeljic R, Popovic DB. Assessment of Spasticity by a Pendulum Test in SCI Patients Who Exercise FES Cycling or Receive Only Conventional Therapy. IEEE Trans Neural Syst Rehabil Eng. 2018 Jan;26(1):181-187. doi: 10.1109/TNSRE.2017.2771466.

ReferenceCitation: Deley G, Denuziller J, Babault N. Functional electrical stimulation: cardiorespiratory adaptations and applications for training in paraplegia. Sports Med. 2015 Jan;45(1):71-82. doi: 10.1007/s40279-014-0250-2. Review.

lead_sponsor: UGECAM Rhône-Alpes

location_facility:
HIA Desgenettes
SSR Val Rosay UGECAM


title: Alterations of Innate and Adaptive Immune Cells During the Course of SARS CoV-2 Pneumonia

acronym: IMMUNO-COVID

summary:
The ongoing pandemic caused by the Severe Acute Respiratory Syndrome Coronavirus 2 (SARS CoV-2) has infected more than one hundred twenty million peoples worldwide one year after its onset with a case-fatality rate of almost 2%. The disease due to the coronavirus 2019 (i.e., COVID-19) is associated with a wide range of clinical symptoms. As the primary site of viral invasion is the upper respiratory airways, lung infection is the most common complication. Most infected patients are asymptomatic or experience mild or moderate form of the disease (80 %). A lower proportion (15%) develop severe pneumonia with variable level of hypoxia that may required hospitalization for oxygen therapy. In the most severe cases (5%), patients evolve towards critical illness with organ failure such as the acute respiratory distress syndrome (ARDS). At this stage, invasive mechanical ventilation is required in almost 70 % and the hospital mortality rises to 37 %.

Immune cells are key players during SARS CoV-2 infection and several alterations have been reported including lymphocytes (T, B and NK) and monocytes depletion, and cells exhaustion. Such alterations were much more pronounced in patients with the most severe form of the disease. Beside, a dysregulated proinflammatory response has also been pointed out as a potential mechanism of lung damage. Finally, COVID-19 is associated with an unexpectedly high incidence of thrombosis which probably results from the viral invasion of endothelial cells.

The investigators aim to explore prospectively the alterations of innate and adaptive immune cells during both the acute and the recovery phase of SARS CoV-2 pneumonia. Flow and Spectral cytometry will be used to perform deep subset profiling focusing on T, B, NK, NKT, gamma-gelta T, monocytes and dendritic cells. Each specific cell type will be further characterized using markers of activation/inhibition, maturation/differenciation and senescence as well as chemokines receptors.

T-cell memory specificity will be explore using specific SARS CoV-2 pentamer. Platelet activation and circulating microparticles will be explore using flow cytometry. Serum SARS CoV-2 antibodies (IgA, IgM, IgG), serum cytokines, and serum biomarkers of alveolar epithelial and endothelial cells will be analyze using ELISA and correlate with the severity of the disease.

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.

name: Chinese Center for Disease Control and Prevention, Beijing, China

family: Wu

full_name: Zunyou Wu

given: Zunyou

family: McGoogan

full_name: Jennifer M. McGoogan

given: Jennifer M.

journal_name: JAMA

oa_host_type: publisher

evidence: open (via free pdf)

host_type: publisher

license_normalized: no license

version: publishedVersion

publisher: American Medical Association (AMA)

publisher_dissemination: American Medical Association

publisher_group: American Medical Association

publisher_normalized: American Medical Association

ReferenceCitation: Kuri-Cervantes L, Pampena MB, Meng W, Rosenfeld AM, Ittner CAG, Weisman AR, Agyekum RS, Mathew D, Baxter AE, Vella LA, Kuthuru O, Apostolidis SA, Bershaw L, Dougherty J, Greenplate AR, Pattekar A, Kim J, Han N, Gouma S, Weirick ME, Arevalo CP, Bolton MJ, Goodwin EC, Anderson EM, Hensley SE, Jones TK, Mangalmurti NS, Luning Prak ET, Wherry EJ, Meyer NJ, Betts MR. Comprehensive mapping of immune perturbations associated with severe COVID-19. Sci Immunol. 2020 Jul 15;5(49). pii: eabd7114. doi: 10.1126/sciimmunol.abd7114.

ReferenceCitation: Giamarellos-Bourboulis EJ, Netea MG, Rovina N, Akinosoglou K, Antoniadou A, Antonakos N, Damoraki G, Gkavogianni T, Adami ME, Katsaounou P, Ntaganou M, Kyriakopoulou M, Dimopoulos G, Koutsodimitropoulos I, Velissaris D, Koufargyris P, Karageorgos A, Katrini K, Lekakis V, Lupse M, Kotsaki A, Renieris G, Theodoulou D, Panou V, Koukaki E, Koulouris N, Gogos C, Koutsoukou A. Complex Immune Dysregulation in COVID-19 Patients with Severe Respiratory Failure. Cell Host Microbe. 2020 Jun 10;27(6):992-1000.e3. doi: 10.1016/j.chom.2020.04.009. Epub 2020 Apr 21.

ReferenceCitation: Qin C, Zhou L, Hu Z, Zhang S, Yang S, Tao Y, Xie C, Ma K, Shang K, Wang W, Tian DS. Dysregulation of Immune Response in Patients With Coronavirus 2019 (COVID-19) in Wuhan, China. Clin Infect Dis. 2020 Jul 28;71(15):762-768. doi: 10.1093/cid/ciaa248.

ReferenceCitation: Zheng M, Gao Y, Wang G, Song G, Liu S, Sun D, Xu Y, Tian Z. Functional exhaustion of antiviral lymphocytes in COVID-19 patients. Cell Mol Immunol. 2020 May;17(5):533-535. doi: 10.1038/s41423-020-0402-2. Epub 2020 Mar 19.

ReferenceCitation: Hue S, Beldi-Ferchiou A, Bendib I, Surenaud M, Fourati S, Frapard T, Rivoal S, Razazi K, Carteaux G, Delfau-Larue MH, Mekontso-Dessap A, Audureau E, de Prost N. Uncontrolled Innate and Impaired Adaptive Immune Responses in Patients with COVID-19 Acute Respiratory Distress Syndrome. Am J Respir Crit Care Med. 2020 Dec 1;202(11):1509-1519. doi: 10.1164/rccm.202005-1885OC.

ReferenceCitation: Ackermann M, Verleden SE, Kuehnel M, Haverich A, Welte T, Laenger F, Vanstapel A, Werlein C, Stark H, Tzankov A, Li WW, Li VW, Mentzer SJ, Jonigk D. Pulmonary Vascular Endothelialitis, Thrombosis, and Angiogenesis in Covid-19. N Engl J Med. 2020 Jul 9;383(2):120-128. doi: 10.1056/NEJMoa2015432. Epub 2020 May 21.

lead_sponsor: Institut Hospitalo-Universitaire Méditerranée Infection

location_facility:
Hopital Europeen Marseille
Hopital Nord

intervention_type: Biological


title: Evaluation of Minimal Hepatic Encephalopathy in Patients With Cirrhosis and Portal Hypertension

acronym: Evencipor

summary: Minimal hepatic encephalopathy (MHE) is a subclinical cognitive impairment and represents the mildest type of hepatic encephalopathy (HE). Portal hypertension is the main complication of cirrhosis and is responsible of severe complications such as HE. The consequence of portal hypertension is the formation of the spontaneous portosystemic shunts (SPSS). The relationship between the SPSS and their characteristics and the prevalence of MHE in patient with cirrhosis is poorly known. The main objective of this study is to evaluate the MHE in patients with cirrhosis and portal hypertension.

lead_sponsor: IHU Strasbourg

location_facility: Service d'Hépato-Gastroentérologie, Hôpitaux Civils


title: Acquired Hemophilia A and Autoimmunity. Study of Lymphocyte Populations and Myeloid-Derived Suppressor Cells

acronym: IMMUNHEMAC

summary:
Acquired hemophilia A is a rare condition of hemostasis secondary to the development of antibodies against factor VIII. This is a potentially serious pathology that can be life-threatening due to the major risk of bleeding caused by the sometimes drastic decrease in the level of circulating factor VIII.

This pathology occurs overwhelmingly in elderly subjects or, more rarely, in young women, during the postpartum period. It appears idiopathic in 50% of cases and associated, for the other cases, with underlying pathologies such as autoimmune pathologies (rheumatoid arthritis and bullous pemphigoid in particular) and neoplasias, or with a particular circumstance represented by the post -partum.

The association between this autoimmune pathology and its association with pathologies of the same type or with circumstances involving the immune system, suggests that common mechanisms could favor its emergence.

This study therefore proposes to study lymphocyte populations and subpopulations as well as Myeloid-Derived Suppressor Cells and the cytokine profile, which are abnormal in a large part of autoimmune pathologies.

lead_sponsor: Nantes University Hospital

location_facility:
CH de Saint Nazaire
CHU de Nantes


title: Secondary Prognostic Index in RefrActory Diffuse Large B Cells Lymphoma

acronym: SPiRAL

summary:
60% of patients with diffuse large B cell lymphoma are healed after first-line treatment which whatever the age. For the remaining 40% of patients (relapses and primary refractories):

38% of patients will be cured with a 2nd line including an autologous haematopoietic cell transplantation for those under 65 years.
for older patients who are not eligible for a autograft: only 70% of patients will be able to receive 2nd line treatment with rates response less than 50%.
the survival rate in patients receiving 3rd line treatment or more is 15% at 2 years. Actually, no standard of chemotherapy is offered to relapsed or refractory patients after 2 therapeutic lines. Subsequent lines lead to hospitalizations for infectious complications or transfusions without clear clinical benefit with often an impacted quality of life.

Palliative care is rarely offered as part of the treatment overall load.

lead_sponsor: Weprom

location_facility: Clinique Victor Hugo / Centre Jean Bernard


title: Effects of an Exergame Focused on Cognitive-motor Interference on the Cognitive and Motor Capacities of Older Adults

acronym: INCOME

summary:
Ageing is accompanied by a high risk of developing physical or cognitive impairments, as well as a decrease in abilities to perform two tasks simultaneously, contributing to loss of autonomy.

Interventions based on the performance of cognitive-motor dual tasks show positive effects on cognitive, physical and emotional development on dual-tasking capabilities. Exergames, interactive serious games combining physical activity and technology, are a certain type of cognitive-motor dual task training. These exergames appear to be cognitively effective, discussed on a physical level, not studied on dual task functions. It is likely that a dual task cognitive-motor with the support of a exercise leads to the same benefits as training without the need for special support.

In addition, the exergames benefit from specific features such as a good immersion and a playful aspect that increase the participant's adhesion. Moreover, the level of security of this type of programme has been little studied. It is likely that cognitive-motor dual tasks training supported by an exercise programme leads to few undesirable events and good adherence.

Many of the recommendations specific needs gaming state that it is important to develop systems that respond to the needs specific to the population concerned in order to be effective. Within the laboratory HAVAE has been developed a tool, the "virtual carpet":

association between a video-projected scene and a monitoring system of position of the participants. This system makes it possible to use as a grid of play the cartography and iconography of the City of Limoges. The investigators suppose that this emphasis on local heritage will encourage the participants leaving their homes, thereby increasing their level of physical activity and their quality of life.

lead_sponsor: University Hospital, Limoges

location_facility:
Résidence Autonomie CASSEAUX
Résidence Autonomie DURKHEIM


title: AntiPlatelet theraPy stratEgy followiNg Left Atrial appenDAGe closurE

acronym: APPENDAGE

summary: The APPENDAGE study is a phase 4 multicentre randomized opened clinical trial comparing 2 different antithrombotic strategies following left atrial appendage closure (LAAC) in patients with non valvular atrial fibrillation (AF). The primary objective of the study is to evaluate the efficacy of Aspirin versus Aspirin + Clopidogrel after LAAC by comparing the occurrence of ischemic lesions on cerebrovascular magnetic resonance imaging (MRI) studies.

lead_sponsor: University Hospital, Bordeaux

location_facility:
Bordeaux University Hospital
Toulouse University Hospital


title: S100B Kinetic During the Occurrence and Treatment of Delayed Cerebral Ischaemia After a Subarachnoid Haemorrhage.

acronym: SKinDCI

summary:
Nearly half of the survivors of subarachnoid haemorrhage (SAH) retain irreversible neurological damage resulting from the early lesions associated with the initial bleeding, and the occurrence of possible delayed cerebral ischaemia (DCI). The early diagnosis of the occurrence of an DCI is therefore a major challenge in order to optimise management before irreversible lesions are formed. However, the means of diagnosis are often not available, and up to a third of DCI are discovered on follow-up images when the lesions are already present. Among the markers of brain injury, S100 calcium-binding protein B (S100B) is an astrocyte protein released into the bloodstream at the time of the appearance of a brain lesion. Its short half-life makes it a prime candidate for patient follow-up to diagnose a new ischemic lesion and assess the effectiveness of its management.

Among the elements at the origin of DCI, the occurrence of proximal vasospasm is the main element on which we can have a therapeutic action. The strategy implemented in the department consists of performing a mechanical angioplasty when proximal vasospasm is detected with a decrease in downstream cerebral perfusion. Nevertheless the benefit of this therapeutic action is discussed and there is currently no early marker of the effectiveness of this procedure.

lead_sponsor: Hospices Civils de Lyon

location_facility:
Hôpital Gabriel Montpied
Hopital Femme Mère Enfant


title: Caracterisation of SARS-Cov2 Infected Patients Hospitalized in Infectious Disease Department

summary: The main objective of this cohort is to characterize COVID-19 patients hospitalized in infectious disease department. The collection of clinical and biological data from start of hospitalization to long-term follow up will contribute to a better description of the patient care, to the identification of predisposition to complication related to the disease, and to the evaluation of the impact of different therapeutical strategies.

ipd_sharing_description: No data sharing plan is scheduled

location_facility:
CHU de NICE - Infectiologie
CHU de NICE - Urgences


title: Crossover Comparison of the Efficacy and Tolerance of Telerobotic vs Standard Ultrasound Exam in Children

summary:
In children with Covid-19, the diagnosis of Kawasaki Disease (KD) and pneumonia should be made very quickly. However, the regional hospitals surrounding Paris don't have the required expertise. The use of MELODY allows the paediatric team to quickly carry out the necessary examinations while avoiding the movement of patients and the risk of contamination.

The MELODY remote system developed by the company AdEchoTech is a CE marking telemedicine technique, allowing an expert to perform an ultrasound scan on a distant patient (several hundred/thousands of kms). The Melody system makes it possible to optimize ultrasound expertise resources wherever they are located (all specialties combined) The feasibility of the clinical use of telerobotic sonography has been demonstrated in adults for abdominal, cardiac and prenatal exam. Thus, the aim of this study is to assess the feasibility of this system in children.

lead_sponsor: Centre Hospitalier Intercommunal Creteil

location_facility:
CHI Créteil
CHI Villeneuve-Saint-Georges


title: Multicenter, Observational Study of Anti-Sars-Cov2 Vaccine Efficacy in Patients With Malignant Pathologies Treated in the University Hospitals of AP-HP. Nord

acronym: COVIDVAC OH

summary:
In the context of malignant disease, it is likely that vaccine efficacy and immunogenicity depends on the type of pathology, stage of the disease, immunosuppression induced by the treatments, in addition to more classic factors such as age, general condition and possibly the type of vaccine used.

There are very little data on the efficacy and immunogenicity of anti-severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) vaccines in patients with malignant disease in the active phase of treatment.

This multicenter observational study aims to assess the efficacy and the immunogenicity of anti-Sars-CoV-2 vaccines in the cohort of patients treated for malignant pathology (solid or hematological tumors) at Saint Louis Hospital and in thoracic oncology patients at Bichat Hospital.

location_facility:
Saint-Louis Hospital, AP-HP
Bichat Hospital, AP-HP


title: BRAF V600-mutated Lung Carcinoma Treated With the Combination of Dabrafenib-trametinib: a Retrospective Evaluation (Secondary Data Use Study of Dabrafenib-Trametinib in "Real Life" for Non-Small Cell Lung Cancer With a BRAF V600 Mutation)

acronym: BLaDE

summary: BLaDE cohort will evaluate overall survival (OS), real world progression-free survival (PFS), best response and duration of treatment in patients with advanced, metastatic Non-Small Cell Lung Cancer (NSCLC) harboring BRAF V600E or non E mutation who received dabrafeninb-trametinib combination or not. Subsequent or previous treatments (treatments delivered after or before dabrafeninb-trametinib combination will be recorded). Those outcomes will be correlated to clinical, pathological, and radiological characteristics of patients.

lead_sponsor: Intergroupe Francophone de Cancerologie Thoracique

location_facility:
Créteil - CHI
Lyon - CRLCC


title: Evaluation of the Efficacy of MaaT013 as Salvage Therapy in Acute GVHD Patients With Gastrointestinal Involvement, Refractory to Ruxolitinib; a Multi-center Open-label Phase III Trial.

acronym: ARES

summary: MaaT013 showed interesting results in steroids and ruxolitinib-resistant aGVHD patients with gut involvement (55% ORR at D28) and 47% and 39% OS at 6 and 12 months respectively (Malard 2020), therefore warrant being tested as salvage therapy in steroid and JAK inhibitors-resistant GI-aGvHD patients. Given the absence of an approved 3rd line strategy or 2nd line strategy in ruxolitinib intolerant patients and the extremely poor prognosis of these patients, who are mostly left with no viable therapeutic option, a single-arm open-label design was proposed.

lead_sponsor: MaaT Pharma

location_facility:
MaaT Pharma
APHP St Antoine


title: Stress, Personality, Attachment and Coping During the Covid Crisis.

acronym: STERACOVID

summary: Because of containment due to Covid-19, the French High Authority for Health (HAS) recommended reinforced monitoring of patients taken in care in the psychiatric ward, with special attention for people over the age of 65. To meet this recommendation, the geriatrics department of the hospital of Charity of Saint-Etienne hospital and the Vinatier hospital in Lyon organized follow-up of these patients by telephone throughout the containment period, thus allowing continuity of care. This pandemic situation and these measures are unprecedented; it is difficult to anticipate the psychological impact on patients.

lead_sponsor: Centre Hospitalier Universitaire de Saint Etienne

location_facility:
CH Le Vinatier
Chu Saint-Etienne


title: ASIA Study: French Register of Inflammatory Eye Disease Secondary to Cancer Immunotherapy

acronym: ASIA

summary:
New anticancer therapies based on lifting the inhibition of the immunological synapse are used in the therapeutic arsenal of a growing number of neoplasias (melanoma, lung cancer, hepatocellular carcinoma, etc.). These "immune check points" inhibitors "(ICPI) target molecules that usually allow immunity to destroy malignant cells. At the systemic level, this results in a loss of immune homeostasis and facilitation of the inflammatory response which may be responsible for dysimmune manifestations distant from the neoplastic site. Thus, since their introduction, ICPIs have been of interest to immunologists, rheumatologists and internists who often find themselves in the first line to deal with this type of side effect (immunotherapy-related adverse events, IRAEs). The frequency of these ARIs between 70% and 90%, depending on the immunotherapy used and the severity of these ARIIs (grade 1-2 vs. 3-5). The overall increase in the number of cancers, the multiplication of available molecules and the expansion of their indications should exponentially increase the number of IRAEs to be supported. Little is known about the epidemiology, risk factors and efficacy of treatments.

In these IRAEs, inflammatory ophthalmological manifestations have been described with an estimated prevalence of between 0.4 and 1% of the patients treated. These attacks are rare and protean (uveitis, scleritis, retinitis, inflammatory orbitopathies, Vogt-Koyanagi-Harada -like…) and reported most often in the form of clinical cases.

The Main objective is to describe the inflammatory ophthalmic disorders linked to anti-cancer immunotherapy.

location_facility: CHU Angers - Service de Médecine Interne - Immunologie Clinique

location_facility: Hôpital de la Croix-Rousse - Service de médecine interne - 103 Grande Rue de la Croix-Rousse


title: Gynecological Follow-up of Patients With Dystrophic Epidermolysis Bullosa (EBD)

summary: Dystrophic epidermolysis bullosa is a rare genetic pathology resulting in fragility of the skin and mucous membranes, causing bubbles and wounds following trauma. Scarring is pathological with a tendency to retraction. The gynecological and in particular the vulvovaginal mucous membranes can be affected but no description of any series is available in the literature. Likewise, some of these patients have a sexual and obstetrical life, despite sometimes-severe damage, but again no specific data is available. The investitigator thus wish to carry out a non-interventional multicenter prospective descriptive study. Better knowledge of gynecological semiology in patients with EBD will allow better adaptation of gynecological follow-up, screening for STDs and gynecological cancers, as well as possible specific complications. This study would eventually allow the draw up of recommendations for our gynecologist / obstetrician colleagues.

ipd_sharing_description: no data sharing plan is schedule

lead_sponsor: Centre Hospitalier Universitaire de Nice

location_facility:
Hôpital Saint Louis
CHU de NICE


title: Feasibility Study of a New Immunoglobulin E (IgE) Assay Method in Urine and Blood

acronym: LuLISA

summary: The main objective is to study the feasibility of a new specific IgE assay using a bioluminescence technique in a pediatric and adult allergic population. For this, we will collect blood, and urine during a blood test scheduled for the follow-up of the patient.

lead_sponsor: University Hospital, Toulouse

location_facility:
University Hospital
Larrey hospital


title: Observational Study of the Use of DBLG1 System in Real Life

summary:
This study will be conducted on human subjects and is observational, prospective and uncontrolled, defined as a category 3 according to the Jardé Law (RIPH3). It is a national and multicentric study. Enrolled patients are Type 1 Diabetes (T1D) patients who receive the DBLG1 System (CE marked medical device) to be treated. Patients have their regular visits with their own clinician. No change from their usual care must and will be done, including trainings and treatment. At the end of the study, patients will keep their system for their usual care and will continue having usual follow-up visits with their clinician.

Data related to their glycemia, complications and quality of life will be collected for 1 year from the beginning of their treatment. A comparison with data collected during the 2 weeks of run-in period, prior to the activation of loop mode, is planned. In case the run-in phase lasts longer than 2 weeks, data collected from the two last weeks only will be kept for analysis and comparison.

The study is completed when all patients have their "end of study" file completed in the electronic Case Report Form (eCRF).

lead_sponsor: Diabeloop

location_facility:
Hôpital Sainte Marguerite - APHM
CHU Grenoble


title: Non-use après Accident Vasculaire cérébral : Influence de la Force et de la précision du Geste à Fournir Lors Des Mouvements du Membre supérieur parétique

acronym: OPTISTROKE

summary: After a stroke, 80% of patients have an upper limb deficit, limiting activity. Some develop a non-use: they can, but do not, use their paretic limb. Non-use is a general phenomenon applied to all situations where the patient applies unnecessary compensation. Several rehabilitation techniques are effective to counter non-use, but there is insufficient knowledge to choose the most suitable technique. Optimal control theory could help guide these choices. It assumes that the chosen coordination satisfies the constraints of the task (force, amplitude, tolerance) while reducing the cost of the movement. This study will assess non-use by anticipating the sensitivity to the constraints of force and precision deduced from the logic of optimal control. The study authors expect to observe a weakness effect: in a reaching task (i.e. when the person has to touch an object placed in front of them), lightening the paretic arm makes it possible to reduce non-use, and a precision effect: in a reaching task, non-use increases with the required spatial precision.

ipd_sharing_description: Anonymised raw datasets and code used for the analysis will be available on reasonable request.

lead_sponsor: Centre Hospitalier Universitaire de Nīmes

location_facility:
CHU de Montpellier
CHU de Nîmes


title: Safety and Performance of the Polaris® 24 Adjustable Valve System in Hydrocephalus Patients' Treatment

acronym: SAPPHYRE

summary: The SAPPHYRE study is an ambispective (retrospective and prospective) PMCF study with the objective to evaluate the safety and performance of the Polaris® 24 adjustable valve system in the treatment of 126 patients with hydrocephalus.

time_perspective: Other

lead_sponsor: Sophysa

location_facility:
La Timone Children's Hospital
La Pitié Salpétrière Hospital


title: Hydrosorb® Versus Control (Water Based Spray) in the Management of Radio-induced Skin Toxicity: Multicentre Controlled Phase III Randomized Trial

acronym: HYDROSORB

summary: The primary objective consisted of avoiding deterioration and/or restoring the integrity of the skin of patients treated by radiotherapy, right from the first signs of grade 1 or 2 radiation dermatitis.

lead_sponsor: Institut Curie

location_facility:
Centre René Huguenin
Institut Curie


title: Evaluation of Medical Practice in the Management of Bone Metastases After Injectable Bone Antiresorptive Treatment, and Its Influence on Quality of Life

acronym: PRISM

summary: To evaluate the current medical practice and its influence on health-related quality of life, in patients who are treated with injectable bone antiresorptive drugs (biphosphonates or denosumab) for at least one year.

lead_sponsor: Centre Hospitalier Universitaire de Besancon

location_facility: Centre Hospitalier Régional Universitaire de Besançon


title: Impact of a Focal Muscle Vibration Protocol in Front of the the Anterior Tibial Muscle in the Subacute Post-stroke Period on Motor Recovery in Hemiplegic Patients.

acronym: VIBRATAC

summary:
In about 40 percent of cases, after a stroke, neuromotor impairment leads to activity limitations and the development of chronic functional disorders, which have a significant impact on patient autonomy.

In the early subacute phase, motor deficit in foot lifters is one of the factors limiting standing posture and ambulation, which is ultimately difficult to rehabilitate due to the lack of available techniques for obtaining early onset of useful active voluntary contraction.

The use of muscular focal vibration therapy, applied to relaxed muscle, may be of interest due to the portability and availability of the system and the neuromotor benefits demonstrated in healthy subjects and in acute and chronic post-stroke patients.

location_facility: Centre Hospitalier Universitaire de Saint-Etienne

location_facility: Le Clos Champirol - Service de Médecine Physique et de Réadaptation


title: Pharmaco-immunological Study of Interferon-alpha and Metronomic Cyclophosphamide Association in Neuroendocrine Tumors

acronym: EPICentro

summary: This study will evaluate the potential immunomodulatory synergy of the association of metronomic cyclophosphamide (CMC) and interferon-alpha (IFN-alpha).

location_facility: Centre Hospitalier Universitaire de Besançon


type: Other Grant/Funding Number

title: Development of a Risk Prediction Model for Identifying Potentially Avoidable Readmissions of Patients Hospitalized With Community-Acquired Pneumonia

summary:
From 10% to 30% of patients hospitalized with community-acquired pneumonia (CAP) are readmitted within 30 days of discharge. These readmissions have negative consequences for the patients and the hospitals where they are treated, including impaired quality of life, exposure to hospital-related adverse events, and increased resource utilization.

Risk-adjusted readmission rates can be easily computed and tracked from computerized hospital discharge data, using validated models. As part of the Hospital Readmission Reduction Program (HRRP) effective in fiscal year 2013, United States hospitals with higher than expected 30-day readmission rates after pneumonia hospitalization have been subject to financial penalties from the Center for Medicare and Medicaid Services (CMS). The underlying logic of the HRRP is based upon the notion that short-term readmission is often a preventable adverse outcome, reflecting suboptimal quality of care during index hospitalization. Yet, published evidence suggests that less than one in four all-cause readmissions are deemed avoidable. Because only avoidable readmissions can be influenced by interventions designed to decrease readmission rates, avoidable readmission is a more relevant metric than all-cause readmission for tracking quality of hospital care for pneumonia.

The purpose of this study is to develop an administrative data-based risk prediction model for identifying potentially avoidable readmissions within 30 days of discharge for patients hospitalized with CAP.

R3P is a retrospective observational cohort study of consecutive adult patients discharged from two hospitals with a diagnosis code of CAP. Data sources include routinely collected hospital discharge data and retrospective chart reviews.

ReferenceCitation: Halfon P, Eggli Y, van Melle G, Chevalier J, Wasserfallen JB, Burnand B. Measuring potentially avoidable hospital readmissions. J Clin Epidemiol. 2002 Jun;55(6):573-87.

ReferenceCitation: Jasti H, Mortensen EM, Obrosky DS, Kapoor WN, Fine MJ. Causes and risk factors for rehospitalization of patients hospitalized with community-acquired pneumonia. Clin Infect Dis. 2008 Feb 15;46(4):550-6. doi: 10.1086/526526.

ReferenceCitation: Skull SA, Andrews RM, Byrnes GB, Campbell DA, Nolan TM, Brown GV, Kelly HA. ICD-10 codes are a valid tool for identification of pneumonia in hospitalized patients aged > or = 65 years. Epidemiol Infect. 2008 Feb;136(2):232-40. Epub 2007 Apr 20.

ReferenceCitation: van Walraven C, Bennett C, Jennings A, Austin PC, Forster AJ. Proportion of hospital readmissions deemed avoidable: a systematic review. CMAJ. 2011 Apr 19;183(7):E391-402. doi: 10.1503/cmaj.101860. Epub 2011 Mar 28. Review.

ReferenceCitation: van Walraven C, Jennings A, Taljaard M, Dhalla I, English S, Mulpuru S, Blecker S, Forster AJ. Incidence of potentially avoidable urgent readmissions and their relation to all-cause urgent readmissions. CMAJ. 2011 Oct 4;183(14):E1067-72. doi: 10.1503/cmaj.110400. Epub 2011 Aug 22.

ReferenceCitation: Lindenauer PK, Normand SL, Drye EE, Lin Z, Goodrich K, Desai MM, Bratzler DW, O'Donnell WJ, Metersky ML, Krumholz HM. Development, validation, and results of a measure of 30-day readmission following hospitalization for pneumonia. J Hosp Med. 2011 Mar;6(3):142-50. doi: 10.1002/jhm.890. Epub 2011 Jan 5.

ReferenceCitation: Mounayar AL, Francois P, Pavese P, Sellier E, Gaillat J, Camara B, Degano B, Maillet M, Bouisse M, Courtois X, Labarère J, Seigneurin A. Development of a risk prediction model of potentially avoidable readmission for patients hospitalised with community-acquired pneumonia: study protocol and population. BMJ Open. 2020 Nov 11;10(11):e040573. doi: 10.1136/bmjopen-2020-040573.

family: Mounayar

full_name: Anne-Laure Mounayar

given: Anne-Laure

family: Francois

full_name: Patrice Francois

given: Patrice

family: Pavese

full_name: Patricia Pavese

given: Patricia

family: Sellier

full_name: Elodie Sellier

given: Elodie

family: Gaillat

full_name: Jacques Gaillat

given: Jacques

family: Camara

full_name: Boubou Camara

given: Boubou

family: Degano

full_name: Bruno Degano

given: Bruno

family: Maillet

full_name: Mylène Maillet

given: Mylène

family: Bouisse

full_name: Magali Bouisse

given: Magali

family: Courtois

full_name: Xavier Courtois

given: Xavier

family: Labarère

full_name: José Labarère

given: José

family: Seigneurin

full_name: Arnaud Seigneurin

given: Arnaud

currency_apc_doaj: GBP

journal_name: BMJ Open

oa_colors: green gold

oa_host_type: publisher;repository

evidence: oa journal (via doaj)

license: cc-by-nc

license_normalized: cc-by-nc

evidence: oa repository (via pmcid lookup)

host_type: repository

repository_normalized: PubMed Central

publisher: BMJ

publisher_dissemination: British Medical Journal

publisher_group: British Medical Journal

publisher_normalized: British Medical Journal

lead_sponsor: University Hospital, Grenoble

location_facility: Centre Hospitalier Annecy Genevois,1 avenue de l'hôpital, Epagny Metz-Tessy,BP 90074

location_facility: Grenoble University Hospital CS10217 Grenoble Cedex 9


title: Central Mechanisms of Chronic Pruritus: Functional and Structural Brain Imaging.

acronym: PRURIM

summary:
The main objective of this study is to identify by functional and structural MRI which are the brain areas activated in various pruritic situations to deduct a model describing the different causes of pruritus.

The investigators are going to compare two chronic pruritus conditions (histaminergic urticaria and non histaminergic: psoriasis) to a healthy control group.

The secondary objective of this study is to specify a classification index from the physiological results obtained by brain imaging to differentiate multiple types of pruritus.

lead_sponsor: University Hospital, Brest

location_facility:
CHRU de Brest
Laurent MISERY


title: Clinical and Therapeutic Impact of Molecular Markers in Myeloproliferative Neoplasms (CTIM3)

summary: Myeloproliferative neoplasms (MPN) are clonal hematopoietic disorders sharing a common natural evolution: a chronic phase, characterized by a major risk of vascular events, followed by an accelerated phase eventually leading to transformation to acute leukemia. MPN include polycythemia vera, essential thrombocythemia, primary myelofibrosis, and rarer entities. During the past years, CML became a paradigm for targeted therapy and personalized cancer medicine. For other MPNs, the discovery of the JAK2V617F mutation followed by many other mutations, opened similar perspectives. However, several questions remain to be answered in MPNs regarding the clinical implication of these major scientific discoveries: what is the clinical impact of JAK2V617F and other molecular biomarkers on the risks of complications and progression? Can these new biomarkers be used in the perspective of a personalized therapy of MPNs? his project will focus on the qualification of a series of known mutations as biomarkers in MPNs based on large multicenter cohorts of patients with well-annotated samples

lead_sponsor: Assistance Publique - Hôpitaux de Paris


title: Study of the Interest of the Parametric Imaging in Positron Emission Tomography on the Recurrence Prognosis at One Year in Patient With Non Small Cell Lung Cancer

acronym: PARAPET

summary:
The purpose of this study is to evaluate the concordance between Positron E mission tomography parametric imaging versus standard PET for the 1 year prognosis of patients with NSCLC treated by radiochemotherapy.

The ancillary study will evaluate the interest of parametric PET imaging during the treatment (around 42 Gray) to detect the local relapse of the lesion in order to propose a treatment re-planification or intensification (not realized on the present study).

ReferenceCitation: Colard E, Delcourt S, Padovani L, Thureau S, Dumouchel A, Gouel P, Lequesne J, Ara BF, Vera P, Taïeb D, Gardin I, Barbolosi D, Hapdey S. A new methodology to derive 3D kinetic parametric FDG PET images based on a mathematical approach integrating an error model of measurement. EJNMMI Res. 2018 Nov 15;8(1):99. doi: 10.1186/s13550-018-0454-9.

family: Colard

full_name: Elyse Colard

given: Elyse

family: Delcourt

full_name: Sarkis Delcourt

given: Sarkis

family: Padovani

full_name: Laetitia Padovani

given: Laetitia

family: Thureau

full_name: Sébastien Thureau

given: Sébastien

family: Dumouchel

full_name: Arthur Dumouchel

given: Arthur

family: Gouel

full_name: Pierrick Gouel

given: Pierrick

family: Lequesne

full_name: Justine Lequesne

given: Justine

family: Ara

full_name: Bardia Farman Ara

given: Bardia Farman

family: Vera

full_name: Pierre Vera

given: Pierre

family: Taïeb

full_name: David Taïeb

given: David

family: Gardin

full_name: Isabelle Gardin

given: Isabelle

family: Barbolosi

full_name: Dominique Barbolosi

given: Dominique

family: Hapdey

full_name: Sébastien Hapdey

journal_name: EJNMMI Research

license: cc-by

license_normalized: cc-by

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

repository_institution: PubMed Central - Europe PMC

publisher: Springer Science and Business Media LLC

publisher_dissemination: Springer-Nature

publisher_group: Springer-Nature

publisher_normalized: Springer

lead_sponsor: Centre Henri Becquerel

location_facility:
APHM
Centre Henri Becquerel


title: The Impact of Telemedicine to Support Palliative Care Resident in Nursing Home: a Cluster Randomized Control Study.

acronym: TELESM

summary: Investigators hypothesize that telemedicine may be an effective tool to improve palliative care in nursing home, by providing on-site specialized and interprofessional consultation. The objective of this study is to assess the impact of telemedicine in decreasing the rate of hospitalization, compared with usual care, in nursing home resident with palliative care needs.

primary_purpose: Supportive Care

location_facility:
CHU Bordeaux
CHU Limoges


title: Impact of Hyperoxia During Cardiopulmonary Bypass in the Occurrence of Cardiovascular Complications After Cardiac Surgery

acronym: CARDIOX

summary: The hypothesis implies that this work is the use of hyperoxia during cardiopulmonary bypass by his heart preconditioning effect is associated with a lower incidence of cardiac arrhythmias (atrial fibrillation, tachycardia or ventricular fibrillation) and lesions of myocardial ischemia-reperfusion injury in cardiac surgery postoperative.

ReferenceCitation: Abou-Arab O, Huette P, Martineau L, Beauvalot C, Beyls C, Josse E, Touati G, Bouchot O, Bouhemad B, Diouf M, Lorne E, Guinot PG. Hyperoxia during cardiopulmonary bypass does not decrease cardiovascular complications following cardiac surgery: the CARDIOX randomized clinical trial. Intensive Care Med. 2019 Oct;45(10):1413-1421. doi: 10.1007/s00134-019-05761-4. Epub 2019 Oct 1.

family: Abou-Arab

full_name: Osama Abou-Arab

given: Osama

family: Huette

full_name: Pierre Huette

family: Martineau

full_name: Lucie Martineau

given: Lucie

family: Beauvalot

full_name: Clémence Beauvalot

given: Clémence

family: Beyls

full_name: Christophe Beyls

given: Christophe

family: Josse

full_name: Estelle Josse

given: Estelle

family: Touati

full_name: Gilles Touati

given: Gilles

family: Bouchot

full_name: Olivier Bouchot

given: Olivier

family: Bouhemad

full_name: Belaïd Bouhemad

given: Belaïd

family: Diouf

full_name: Momar Diouf

given: Momar

family: Lorne

full_name: Emmanuel Lorne

given: Emmanuel

family: Guinot

full_name: Pierre-Grégoire Guinot

given: Pierre-Grégoire

journal_name: Intensive Care Medicine

lead_sponsor: Centre Hospitalier Universitaire, Amiens

location_facility:
CHU Amiens-Picardie
CHU Dijon-Bourgogne


title: Evaluation of the Success of Prophylactic Enteral Nutrition in Therapeutic Intensification With Autograft of Autologous Hematopoietic Cells in Hematology

acronym: GAGNE

summary: When the digestive tract is functional, learned societies recommend the use of a nutritional support by enteral feeding. Indeed, it has many advantages (maintenance of gut trophicity, reduction of the risk of infection by reducing the incidence of bacterial translocations,...). It has been used for about fifteen years in hematology departments and offers promising results in the context of allogeneic transplantation with prospective trials in progress (NEPHA study). However, its tolerance has not been studied during autologous transplantation. This study aims to assess the success of enteral nutrition in this setting.

lead_sponsor: University Hospital, Bordeaux

location_facility:
CH de la Côte Basque
CHU Bordeaux

intervention_type: Dietary Supplement


title: Prospective, Two-center , Randomized, ITT , Parallel Group Evaluating the Interest of the Instillation of Saline Intraperitoneally (INSI ) Versus Instillation of Naropin the Surgical Site Versus Lung Recruitment Maneuvers ( PVM ) in the Management of Pain After Laparoscopic Cholecystectomy in Ambulatory Care

acronym: VSD

summary:
Known to reduce analgesics and length of hospitalization in conventional surgery, laparoscopy is characterized by frequent post-operative pain and can decrease the patient's quality of immediate postoperative life and sometimes the results of decision ambulatory care.

In order to reduce these postoperative pain, various methods have been evaluated in numerous studies to determine their analgesic role.

As part of abdominal surgery, local anesthetics (Naropin (Ropivacaine)) are generally administered in the end of surgery to reduce postoperative pain and promote recovery of the patient. In addition, it is also possible to instill the anesthetic directly into the abdominal cavity reducing pain transmitted by nociceptor viscera.

In recent years, new methods have been proposed such as lung recruitment maneuvers and the instillation of saline solution to reduce postoperative pain.

However, no recommendation is on the use of intraperitoneal saline under the management of postoperative pain after laparoscopic cholecystectomy in ambulatory care.

status: Withdrawn

location_facility:
CHU Amiens
CH Beauvais


title: Evaluation of the Added Value of Sophrology on the Intensity of Craving During Smoking Withdrawal

acronym: SOPHCIG

summary: To evaluate the added value of Sophrology on the intensity of craving during cigarette withdrawal.

lead_sponsor: Centre Hospitalier Intercommunal Creteil

location_facility: CHI Créteil Equipe de liaison et de soins en addictologie (ELSA)


title: Study of the Influence of Glycaemic Balance on the Ability of Apolipoprotein C1 to Inhibit Cholesterol Ester Transfer Protein (CETP) in Type-1 Diabetes Patients

summary:
In type-1 diabetes patients, bad cholesterol tends to accumulate because apoC1 function is slowed down.

ApoC1 is a protein whose role is to diminish the activity of CETP, another protein that regulates cholesterol transfer in the body.

The aim of this study is to determine whether it is possible to correct apoC1 function by improving glycaemic balance.

240 persons will be recruited in this study and allocated to one of two groups:

160 Type-1 diabetes patients with uncontrolled diabetes:

4 additional blood samples will be taken at the time of the systematic biological examination at inclusion and then again 3 months later.

80 control subjects with normal lipids and normal glycaemia balance will be included in the study following the results of the biological assays.

4 blood samples will be taken at the time of inclusion.

lead_sponsor: Centre Hospitalier Universitaire Dijon

location_facility:
CHU Dijon Bourgogne
CHU de Besançon


title: Evaluation of Two Surgical Strategies for Robotic Implantation of Total Knee Prostheses (Stryker), Cemented Versus Uncemented. Prospective, Randomized, Single-center, Multisite Non-inferiority Study.

acronym: MAKO CIMENT

summary:
Total knee replacement surgery (TKA) is a treatment for advanced tibial-femoral osteoarthritis. This intervention is justified in case of significant discomfort and failure of medical treatment. It aims to replace the native internal and external femoro-tibial joints with a joint between a femoral implant and a tibial implant.

Implants can be cemented or cementless. The longevity of these implants depends among other things on the quality of the bone fixation of the implants. It is therefore essential that this fixation be evaluated. The advantages of an uncemented TKA are the preservation of bone stock, the absence of wear by cement debris and prolonged fixation thanks to osseointegration. These characteristics are all the more interesting in a young population.

Numerous studies have been carried out on the survival of TKA with and without cement. The results found are not unanimous and mainly concern the survival of the implants and the presence of radiological signs of loosening. In addition, no study has evaluated the results of TKA with or without cement implanted using robotic assistance. The precision provided by the robotic system could improve the results of these uncemented implants.

Very few studies are interested in the functional results according to the cementation or not of TKA. And most of these studies do not have a high level of methodological evidence.

We would like to prospectively evaluate the functional results, survival, as well as the rate of radiological border after TKA with or without cement posed with robotic assistance, in the short and medium term.

lead_sponsor: Hospices Civils de Lyon

location_facility: Department of orthopedic surgery, Hopital Nord Croix-Rousse- Hospices Civils de Lyon

location_facility: Chirurgie Orthopédique et Traumatologique Centre Hospitalier Lyon Sud, Hospices Civils de Lyon


ReferenceCitation: Depaulis C, Steer N, Garessus L, Chassard D, Aubrun F. Evaluation of the effectiveness and tolerance of tetracosactide in the treatment of post-dural puncture headaches (ESYBRECHE): a study protocol for a randomised controlled trial. Trials. 2020 Jan 8;21(1):55. doi: 10.1186/s13063-019-4015-y.

apc_source: openAPC

family: Depaulis

full_name: Célia Depaulis

given: Célia

family: Steer

full_name: Nadia Steer

given: Nadia

family: Garessus

full_name: Léa Garessus

given: Léa

family: Chassard

full_name: Dominique Chassard

family: Aubrun

full_name: Frédéric Aubrun

given: Frédéric

journal_name: Trials

evidence: oa repository (via page says license)

repository_normalized: Research Square

version: submittedVersion

repositories:
PubMed Central
Research Square

acronym: ESYBRECHE

location_facility: Hospices Civils de Lyon / hôpital de la Croix rousse

location_facility: Hospices Civils de Lyon - Hôpital Femme Mère Enfant

source: euctr

title: Evaluation of the Effectiveness and Tolerance of Tetracosactide Synacthen® in the Treatment of Post Dural Puncture Headaches (ESYBRECHE)

summary: The aim of the study is to assess the efficacy and safety of Synacthène® versus placebo in the treatment of post-dural puncture syndrome in patients receiving epidural analgesia, spinal analgesia, or combined spinal-epidural analgesia for labour.


acronym: PFAPA

summary: This cohort study aims to assess the quality of life (or welfare) related to the health of children and adolescents with an non genetics auto-inflammatory disease PFAPA or Marshall syndrome to compare it to children or adolescents with recurrent fever genetics of Familial Mediterranean fever (FMF) in order to improve their overall care.

lead_sponsor: Versailles Hospital

location_facility:
Centre hospitalier de Versailles
CH de Bicètre


title: Per-Operative Radiotherapy (RPO) by Papillon +TM in Localized Breast Cancer : Faisability and Toxicity Study

summary: Phase II study; open recruitment, multicentrique. The aim of this clinical research is to evaluate faisability and toxicity of the per-operative radiotherapy using PAPILLON + TM device for localized breast cancers patients over 65 years.

lead_sponsor: Centre Antoine Lacassagne

location_facility:
Centre Antoine Lacassagne
Pôle Santé République


title: Evaluation of the Efficacy of BOARDING RING Glasses in the Treatment of Vestibular Neuritis

acronym: NEVRING

summary: Vestibular neuritis is a brutal and continuous dizzying syndrome of peripheral (vestibular) origin without cochlear or other associated involvement. Specifically, vestibular neuritis is inflammation of the nerve that innervates the vestibular canals (the inner ear). It is characterized by the sudden onset of intense and prolonged vertigo accompanied by postural imbalance, nausea and vomiting, without hearing impairment or other neurological symptoms. Vestibular neuritis is the second cause of peripheral vertigo after benign paroxysmal positional vertigo. It represents approximately 7% of patients consulting for vertigo. The purpose of this study is to evaluate if wearing Boarding Ring glasses can be accelerated vestibular compensation.

location_facility:
CH Pays de Morlaix
CH de Cornouaille Quimper


title: Immuno Monitoring in Patient With Epithelial Ovarian Cancer Eligible to PARP Inhibitors

acronym: IMMUNOPARP

summary: This study concerns the creation of a biological collection (blood samples) in patients with Epithelial Ovarian Cancer in in order to describe the immune response with PARP inhibitors.

lead_sponsor: Centre Georges Francois Leclerc

location_facility:
CHRU Jean Minjoz
Centre Georges Francois Leclerc


title: Randomized, Comparative Pilot Study Evaluating the Effectiveness of autoHYpnosis by Anchoring in the Prevention of Anxiety Related to Wearing the Mask for Radiotherapy of Head and Neck Tumors

acronym: HYMACO

summary:
HYMACO is a monocentric, randomized comparative pilot study with a total duration of 25 months. The purpose of this study is to evaluate the effectiveness of autoHYpnosis by anchoring in the prevention of anxiety related to wearing the mask for radiotherapy of head and neck tumors.

60 patients will be randomized into 3 arms ARM A : Standard care ARM B : Autohypnosis ARM C : Musicotherapy This study is carried out during the first 5 radiotherapy sessions because this is decisive for the good progress of subsequent sessions

lead_sponsor: Institut de Cancérologie de Lorraine