title: Investigating Minimal Residual Disease in Autopreserved Ovarian Tissue in Cases of Neoplastic Pathology

acronym: OVAGRAFT

summary: Cryopreservation of ovarian tissue is offered to young girls and women aged under 35 who have to undergo sterilizing gonadotoxic treatment, with the aim of preserving their fertility. The main part of the ovary is preserved, as primordial and primary follicles are resistant to freezing / thawing protocols. In the absence of other techniques (in vivo maturation, injecting isolated ovarian follicles, etc.) autografting this cryopreserved tissue is currently the only technique allowing fertility to be restored. Autograft is possible only if the indication for ovary cryopreservation is a non-neoplastic pathology or a malignant pathology with a low risk of ovarian metastasis. In other cases of neoplastic pathologies, particularly in cases of acute leukemia, tissue cannot as yet be re-used due to the lack of any codified technique for evaluating residual disease (MRD). The team has for two years been developing and validating a technique to look for residual disease in fragments of ovarian cortex in cases of acute leukemia. This technique is based on an original protocol for dissociating ovarian tissue to obtain a population of isolated ovarian cells that may be analyzed by multicolor flow cytometry. The specificity and sensitivity of the technique have been demonstrated in an experimental model. This model consists in using 8 color flow cytometry to look for characterizable leukemia cells added in different dilutions to a population of isolated ovarian cells taken from model ovarian cortex and up to a dilution of 10-5. When the molecular markers were present on diagnosis, they were found by RQ-PCR (Real-Time Quantitative Polymerase Chain Reaction) with the same dilutions. The model tissue came from laparoscopic ovarian drilling in patients with polycystic ovary syndrome. The main objective of this project is to validate techniques that have been previously codified with different populations of leukemia cells that may be characterized. We then aim to adapt and validate this technique to look for MRD using 8 color flow cytometry on cryopreserved fragments of ovarian cortex from leukemia patients that are at risk of metastasis. Secondary objectives will be to implement procedures for oncological qualification of grafts in cases of malignant pathology and to consider the recommendations for using this cryopreserved ovarian tissue through the autograft technique for these indications.

ReferenceCitation: Roux C, Amiot C, Agnani G, Aubard Y, Rohrlich PS, Piver P. Live birth after ovarian tissue autograft in a patient with sickle cell disease treated by allogeneic bone marrow transplantation. Fertil Steril. 2010 May 1;93(7):2413.e15-9. doi: 10.1016/j.fertnstert.2009.12.022. Epub 2010 Feb 1.

ReferenceCitation: Amiot C, Angelot-Delettre F, Zver T, Alvergnas-Vieille M, Saas P, Garnache-Ottou F, Roux C. Minimal residual disease detection of leukemic cells in ovarian cortex by eight-color flow cytometry. Hum Reprod. 2013 Aug;28(8):2157-67. doi: 10.1093/humrep/det126. Epub 2013 Apr 30.

ReferenceCitation: Fauque P, Ben Amor A, Joanne C, Agnani G, Bresson JL, Roux C. Use of trypan blue staining to assess the quality of ovarian cryopreservation. Fertil Steril. 2007 May;87(5):1200-7. Epub 2007 Feb 20.

ReferenceCitation: Zver T, Alvergnas-Vieille M, Garnache-Ottou F, Roux C, Amiot C. A new method for evaluating the risk of transferring leukemic cells with transplanted cryopreserved ovarian tissue. J Assist Reprod Genet. 2015 Aug;32(8):1263-6. doi: 10.1007/s10815-015-0512-4. Epub 2015 Jul 3.

ReferenceCitation: Zver T, Alvergnas-Vieille M, Garnache-Ottou F, Ferrand C, Roux C, Amiot C. Minimal residual disease detection in cryopreserved ovarian tissue by multicolor flow cytometry in acute myeloid leukemia. Haematologica. 2014 Dec;99(12):e249-52. doi: 10.3324/haematol.2014.113373. Epub 2014 Sep 19.

lead_sponsor: Centre Hospitalier Universitaire de Besancon


title: Cognitive, Morphological and Neurobiological Progressive Aspects in Bipolar Disorders in the Elderly: Toward to a Neurodegenerescence Detection?

acronym: BIPAGE

summary: The purpose of this study is to identify association between cerebrospinal fluid Alzheimer's Disease's neurodegenerescence biomarkers (tau, ptau, Aß40 and Aß1-42) and occurrence of cognitive deficits in older patients with bipolar disorders.

status: Unknown status

study_completion_date_type: Anticipated

study_type: Interventional

design_allocation: Non-Randomized

primary_purpose: Screening

enrollment_type: Anticipated

ReferenceType: background

ReferenceCitation: Ali SO, Denicoff KD, Altshuler LL, Hauser P, Li X, Conrad AJ, Smith-Jackson EE, Leverich GS, Post RM. Relationship between prior course of illness and neuroanatomic structures in bipolar disorder: a preliminary study. Neuropsychiatry Neuropsychol Behav Neurol. 2001 Oct-Dec;14(4):227-32.

ReferenceCitation: Amieva H, Le Goff M, Millet X, Orgogozo JM, Pérès K, Barberger-Gateau P, Jacqmin-Gadda H, Dartigues JF. Prodromal Alzheimer's disease: successive emergence of the clinical symptoms. Ann Neurol. 2008 Nov;64(5):492-8. doi: 10.1002/ana.21509.

ReferenceCitation: Bora E, Vahip S, Gonul AS, Akdeniz F, Alkan M, Ogut M, Eryavuz A. Evidence for theory of mind deficits in euthymic patients with bipolar disorder. Acta Psychiatr Scand. 2005 Aug;112(2):110-6.

ReferenceCitation: Chételat G, Eustache F, Viader F, De La Sayette V, Pélerin A, Mézenge F, Hannequin D, Dupuy B, Baron JC, Desgranges B. FDG-PET measurement is more accurate than neuropsychological assessments to predict global cognitive deterioration in patients with mild cognitive impairment. Neurocase. 2005 Feb;11(1):14-25.

ReferenceCitation: Chételat G, Desgranges B, Eustache F. [Brain profile of hypometabolism in early Alzheimer's disease: relationships with cognitive deficits and atrophy]. Rev Neurol (Paris). 2006 Oct;162(10):945-51. Review. French.

ReferenceCitation: Corder EH, Saunders AM, Strittmatter WJ, Schmechel DE, Gaskell PC, Small GW, Roses AD, Haines JL, Pericak-Vance MA. Gene dose of apolipoprotein E type 4 allele and the risk of Alzheimer's disease in late onset families. Science. 1993 Aug 13;261(5123):921-3.

ReferenceCitation: Delaloye C, Moy G, Baudois S, de Bilbao F, Remund CD, Hofer F, Ragno Paquier C, Campos L, Weber K, Gold G, Moussa A, Meiler CC, Giannakopoulos P. Cognitive features in euthymic bipolar patients in old age. Bipolar Disord. 2009 Nov;11(7):735-43. doi: 10.1111/j.1399-5618.2009.00741.x. Epub 2009 Aug 28.

ReferenceCitation: Delaloye C, Moy G, de Bilbao F, Weber K, Baudois S, Haller S, Xekardaki A, Canuto A, Giardini U, Lövblad KO, Gold G, Giannakopoulos P. Longitudinal analysis of cognitive performances and structural brain changes in late-life bipolar disorder. Int J Geriatr Psychiatry. 2011 Dec;26(12):1309-18. doi: 10.1002/gps.2683. Epub 2011 Mar 10.

ReferenceCitation: Doring TM, Kubo TT, Cruz LC Jr, Juruena MF, Fainberg J, Domingues RC, Gasparetto EL. Evaluation of hippocampal volume based on MR imaging in patients with bipolar affective disorder applying manual and automatic segmentation techniques. J Magn Reson Imaging. 2011 Mar;33(3):565-72. doi: 10.1002/jmri.22473.

ReferenceCitation: Ewers M, Buerger K, Teipel SJ, Scheltens P, Schröder J, Zinkowski RP, Bouwman FH, Schönknecht P, Schoonenboom NS, Andreasen N, Wallin A, DeBernardis JF, Kerkman DJ, Heindl B, Blennow K, Hampel H. Multicenter assessment of CSF-phosphorylated tau for the prediction of conversion of MCI. Neurology. 2007 Dec 11;69(24):2205-12.

ReferenceCitation: Fagan AM, Mintun MA, Shah AR, Aldea P, Roe CM, Mach RH, Marcus D, Morris JC, Holtzman DM. Cerebrospinal fluid tau and ptau(181) increase with cortical amyloid deposition in cognitively normal individuals: implications for future clinical trials of Alzheimer's disease. EMBO Mol Med. 2009 Nov;1(8-9):371-80. doi: 10.1002/emmm.200900048.

ReferenceCitation: Hindley NJ, Jobst KA, King E, Barnetson L, Smith A, Haigh AM. High acceptability and low morbidity of diagnostic lumbar puncture in elderly subjects of mixed cognitive status. Acta Neurol Scand. 1995 May;91(5):405-11.

ReferenceCitation: Jones LD, Payne ME, Messer DF, Beyer JL, MacFall JR, Krishnan KR, Taylor WD. Temporal lobe volume in bipolar disorder: relationship with diagnosis and antipsychotic medication use. J Affect Disord. 2009 Apr;114(1-3):50-7. doi: 10.1016/j.jad.2008.07.003. Epub 2008 Aug 8.

ReferenceCitation: Kessing LV, Nilsson FM. Increased risk of developing dementia in patients with major affective disorders compared to patients with other medical illnesses. J Affect Disord. 2003 Feb;73(3):261-9.

ReferenceCitation: Kessing LV, Andersen PK. Does the risk of developing dementia increase with the number of episodes in patients with depressive disorder and in patients with bipolar disorder? J Neurol Neurosurg Psychiatry. 2004 Dec;75(12):1662-6.

ReferenceCitation: Li G, Sokal I, Quinn JF, Leverenz JB, Brodey M, Schellenberg GD, Kaye JA, Raskind MA, Zhang J, Peskind ER, Montine TJ. CSF tau/Abeta42 ratio for increased risk of mild cognitive impairment: a follow-up study. Neurology. 2007 Aug 14;69(7):631-9.

ReferenceCitation: Masouy A, Chopard G, Vandel P, Magnin E, Rumbach L, Sechter D, Haffen E. Bipolar disorder and dementia: where is the link? Psychogeriatrics. 2011 Mar;11(1):60-7. doi: 10.1111/j.1479-8301.2010.00348.x.

ReferenceCitation: Martino DJ, Igoa A, Marengo E, Scápola M, Ais ED, Strejilevich SA. Cognitive and motor features in elderly people with bipolar disorder. J Affect Disord. 2008 Jan;105(1-3):291-5. Epub 2007 Jun 18.

ReferenceCitation: Meeks S. Bipolar disorder in the latter half of life: symptom presentation, global functioning and age of onset. J Affect Disord. 1999 Jan-Mar;52(1-3):161-7.

ReferenceCitation: Peskind E, Nordberg A, Darreh-Shori T, Soininen H. Safety of lumbar puncture procedures in patients with Alzheimer's disease. Curr Alzheimer Res. 2009 Jun;6(3):290-2.

ReferenceCitation: Peskind ER, Riekse R, Quinn JF, Kaye J, Clark CM, Farlow MR, Decarli C, Chabal C, Vavrek D, Raskind MA, Galasko D. Safety and acceptability of the research lumbar puncture. Alzheimer Dis Assoc Disord. 2005 Oct-Dec;19(4):220-5.

ReferenceCitation: Preuss UW, Watzke S, Choi JH. Diagnostic correlates of Alzheimer dementia in a U.S. Nationwide inpatient sample. Am J Geriatr Psychiatry. 2010 Sep;18(9):821-9. doi: 10.1097/JGP.0b013e3181ca3a13.

ReferenceCitation: Saunders AM, Strittmatter WJ, Schmechel D, George-Hyslop PH, Pericak-Vance MA, Joo SH, Rosi BL, Gusella JF, Crapper-MacLachlan DR, Alberts MJ, et al. Association of apolipoprotein E allele epsilon 4 with late-onset familial and sporadic Alzheimer's disease. Neurology. 1993 Aug;43(8):1467-72.

ReferenceCitation: Tapiola T, Alafuzoff I, Herukka SK, Parkkinen L, Hartikainen P, Soininen H, Pirttilä T. Cerebrospinal fluid {beta}-amyloid 42 and tau proteins as biomarkers of Alzheimer-type pathologic changes in the brain. Arch Neurol. 2009 Mar;66(3):382-9. doi: 10.1001/archneurol.2008.596.

ReferenceCitation: Thomann PA, Kaiser E, Schönknecht P, Pantel J, Essig M, Schröder J. Association of total tau and phosphorylated tau 181 protein levels in cerebrospinal fluid with cerebral atrophy in mild cognitive impairment and Alzheimer disease. J Psychiatry Neurosci. 2009 Mar;34(2):136-42.

ReferenceCitation: Vemuri P, Wiste HJ, Weigand SD, Knopman DS, Trojanowski JQ, Shaw LM, Bernstein MA, Aisen PS, Weiner M, Petersen RC, Jack CR Jr; Alzheimer's Disease Neuroimaging Initiative. Serial MRI and CSF biomarkers in normal aging, MCI, and AD. Neurology. 2010 Jul 13;75(2):143-51. doi: 10.1212/WNL.0b013e3181e7ca82.

ReferenceCitation: Verghese PB, Castellano JM, Holtzman DM. Apolipoprotein E in Alzheimer's disease and other neurological disorders. Lancet Neurol. 2011 Mar;10(3):241-52. doi: 10.1016/S1474-4422(10)70325-2. Review.

ReferenceCitation: Wingo AP, Harvey PD, Baldessarini RJ. Neurocognitive impairment in bipolar disorder patients: functional implications. Bipolar Disord. 2009 Mar;11(2):113-25. doi: 10.1111/j.1399-5618.2009.00665.x. Review.

ReferenceCitation: Zetterberg H, Tullhög K, Hansson O, Minthon L, Londos E, Blennow K. Low incidence of post-lumbar puncture headache in 1,089 consecutive memory clinic patients. Eur Neurol. 2010;63(6):326-30. doi: 10.1159/000311703. Epub 2010 Jun 3.

lead_sponsor: University Hospital, Grenoble

intervention_type: Other

lead_sponsor_type: academique

status_simplified: Unknown


title: Impact of Body Mass Index on the Agreement Between Ultrasound- and Clinical Assessments of Disease Activity in RA : Cross-sectionnal Study

acronym: RABODI

summary: Comparison of the level of agreement between Power Doppler ultrasound measured number of synovitis (≥ grade 1 on a semi-quantitative scale) and clinically defined number of swollen joints in obese (i.e. BMI>30) versus normally weighted RA patients.

study_start_date_type: Actual

status: Completed

study_completion_date_type: Actual

study_type: Observational

time_perspective: Prospective

enrollment_type: Actual

ipd_sharing: No

lead_sponsor: University Hospital, Montpellier

status_simplified: Completed


title: Safety & Efficacy of Neoadjuvant Immunotherapy With Durvalumab (MEDI 4736) Combined With Neoadjuvant Chemotherapy (Gemcitabine/Cisplatin or Gemcitabine/Carboplatin) in Patients With Operable, High-risk, Localized Urothelial Carcinoma of the Upper Urinary Tract

acronym: iNDUCT

summary:
Following radical nephrectomy (RNU) for upper tract urothelial carcinoma (UTUC) most patients face a poor prognosis. Indeed, patients who have undergone RNU for UTUC have 5-year recurrence-free and cancer specific survival probabilities of 69% and 73% respectively.

The primary objective of this study is to assess the pathological complete response rate to combination therapy with neoadjuvant durvalumab and chemotherapy (Gemcitabine/Cisplatin) before surgery in patients with high-risk, localized, non-metastatic urothelial carcinomas of the upper tract.

status: Recruiting

primary_purpose: Treatment

lead_sponsor: Centre Hospitalier Universitaire de Nīmes

intervention_type: Drug

status_simplified: Ongoing


title: Cost-utility Analysis of the Follow-up of Exclusive Telemedicine Pacemakers, Compared to Conventional Pacemakers

acronym: TELEPACE

summary: TELEPACE is an economic evaluation that aims to determine the probability at which Home Monitoring without physical examinations, could be cost effective, compared to the conventional treatment by face to face consultations. Patient will be randomized in a control group followed according to the current guidelines and and active group exclusively followed by remote monitoring. The study will end after a 4 year follow-up.

design_allocation: Randomized

primary_purpose: Other

lead_sponsor: Nantes University Hospital


title: Prevention of New Onset Diabetes After Transplantation by a Short Term Treatment of Vildagliptin in the Early Post-transplant Period

acronym: PRODIG

summary:
Post-transplant diabetes affects 15 to 20% of renal transplant patients and contributes to increased morbidity and reduced survival of transplants and patients. Corticosteroids, anti-calcineurin and mammilian Target OF Rapamycin (mTOR) inhibitors have a major diabetogenic impact and greatly contribute to the increase in diabetes prevalence after transplantation.

There are to date few studies concerning the pharmacological prevention of post-transplant diabetes. Hecking et al. have recently reported that a short treatment with insulin, administered immediately after transplantation, reduce the incidence of de novo diabetes one-year post-transplant. This study included 50 renal transplant patients and showed that a three months treatment of (Neutral Protamine Hagedorn) NPH insulin decreased HbA1c. The occurrence of diabetes, a secondary end-point, was reduced by 73% in the treated group.

No further pharmacological strategy has been developed to date. Relevant experimental evidences suggest that gliptins could be used in the pharmacological prevention of post-transplant diabetes. These drugs are inhibitors of dipeptidyl peptidase-4 (DPP-4), which inactivates the incretins, the glucagon-like peptide-1 (GLP-1) and the gastric inhibitory polypeptide (GIP). DPP-4 inhibition causes an increase in the GLP-1 and GIP concentrations which induce insulin secretion and inhibition of glucagon secretion. The gliptins are approved for the treatment of type 2 diabetes. Beyond the effects on blood glucose, gliptins have pleiotropic effects including a protective effect on β cells and anti-inflammatory effect.

The additional cost associated with new-onset diabetes after transplantation could be also significantly reduced by efficient prevention. A US study found that, for the period between 1994 and 1998, a newly diagnosed diabetic patient has cost $21,500 of medical expenses 2 years after transplantation. Moreover, transplantation resulting in one of the best increases of patients' quality of life, its estimate is essential in the treatment evaluation of this population.

primary_purpose: Prevention

ReferenceType: derived

ReferenceCitation: Gaiffe E, Crepin T, Bamoulid J, Courivaud C, Büchler M, Cassuto E, Albano L, Chemouny JM, Choukroun G, Hazzan M, Kessler L, Legendre C, Le Meur Y, Ouali N, Thierry A, Anota A, Nerich V, Limat S, Bonnetain F, Vernerey D, Ducloux D. PRODIG (Prevention of new onset diabetes after transplantation by a short term treatment of Vildagliptin in the early renal post-transplant period) study: study protocol for a randomized controlled study. Trials. 2019 Jun 21;20(1):375. doi: 10.1186/s13063-019-3392-6.

family: Gaiffe

full_name: E. Gaiffe

given: E.

sequence: first

family: Crepin

full_name: T. Crepin

given: T.

sequence: additional

family: Bamoulid

full_name: J. Bamoulid

given: J.

family: Courivaud

full_name: C. Courivaud

given: C.

family: Büchler

full_name: M. Büchler

given: M.

family: Cassuto

full_name: E. Cassuto

family: Albano

full_name: L. Albano

given: L.

family: Chemouny

full_name: J. M. Chemouny

given: J. M.

family: Choukroun

full_name: G. Choukroun

given: G.

family: Hazzan

full_name: M. Hazzan

family: Kessler

full_name: L. Kessler

family: Legendre

full_name: C. Legendre

family: Le Meur

full_name: Y. Le Meur

given: Y.

family: Ouali

full_name: N. Ouali

given: N.

family: Thierry

full_name: A. Thierry

given: A.

family: Anota

full_name: A. Anota

family: Nerich

full_name: V. Nerich

given: V.

family: Limat

full_name: S. Limat

given: S.

family: Bonnetain

full_name: F. Bonnetain

given: F.

family: Vernerey

full_name: D. Vernerey

given: D.

family: Ducloux

full_name: D. Ducloux

bso_classification: Medical research

currency_apc_doaj: GBP

datasource: user

genre: journal-article

genre_raw: journal-article

journal_name: Trials

oa_colors: green gold

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - ENPC

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Institut Pasteur

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


title: PERCING : Ovarian Drilling Versus Ovarian Stimulation + Intra Uterine Insemination (IUI) + Metformin in the PCOS (PolyCystic Ovaries Syndrome) Treatment

acronym: PERCING

summary:
PolysCsytic Ovaries Syndrome (PCOS) is the most frequent endocrinopathy. The first stage of infertility treatment is Clomiphene Citrate which leads to 50 % pregnancies. In case of failure, it is possible to propose surgical ovarian drilling or ovarian hyperstimulation with Intra Uterine Insemination (IUI) which lead to 50% pregnancies each. However, surgical treatment could be associated to surgical complications, and medical treatment could be associated to ovarian hyperstimulation syndrome and/or multiple pregnancies.

The aim of this study is to compare the two treatments to demonstrate the equivalence of efficacy and the diminution of multiple pregnancies by the surgical treatments. After an ambulatory surgery we will observe the spontaneous fertility during 9 months. For the medical treatment, Metformin is proposed during 9 months associated with 3 cycles of ovarian hyperstimulation and IUI if the sperm is normal

ReferenceCitation: Fernandez H, Watrelot A, Alby JD, Kadoch J, Gervaise A, deTayrac R, Frydman R. Fertility after ovarian drilling by transvaginal fertiloscopy for treatment of polycystic ovary syndrome. J Am Assoc Gynecol Laparosc. 2004 Aug;11(3):374-8.

lead_sponsor: Assistance Publique - Hôpitaux de Paris

intervention_type: Procedure


title: French National Cohort of People With Type 1 Diabètes: the SFDT1 Study

summary:
Cardiovascular (CV) diseases are the most frequent type 1 diabetes (T1D) complications. A recent epidemiological study showed that patients with T1D have a two-fold CV mortality risk, even in case of good glycemic control. In addition, it has been shown that patients with T1D with no traditional CV risk factors had about a 80% higher risk of cardiovascular event compared to non-diabetic individuals. This indicates that further modifiable risk factors in relation to CV mortality remain to be identified.

One of the candidates that could help to disentangle the factors associated with the increased CV mortality in T1D patients is glycemic variability which could contribute to diabetes complications. Indeed, severe hypoglycaemia, one of the most severe consequence of glycaemic variability, are associated with a higher mortality in patients with type 1 and type 2 diabetes.

In order to evaluate the relation between glycemic variability, insulin therapy modalities and CV risk as well as some other questions related to health determinants of T1D, we are building up a large observational, prospective, multi-centric cohort study of patients gathering 15,000 patients with T1D, age above 6 years old, to perform the following:

Collecting clinical information
Evaluating Glycemic variability (assessed by the coefficient of variation of glucose (CV) calculated from automatically downloaded continuous glucose monitoring data (CGM)
Biobanking including plasma, DNA, urine, saliva and hair.
Collecting patients' reported outcomes through auto-questionnaires (online questionnaires).
Doing an active follow-up for a period of 30 years with an intermediate visit every 3 years.

We plan to link the data to national Health data system (Système National de Données de Santé, SNDS) in order to exhaustively collect health events as death, CV events and hospitalizations (including severe hypoglycemia).

ipd_sharing: Undecided

lead_sponsor: Fondation Francophone pour la Recherche sur le Diabete

lead_sponsor_type: industriel


title: Management of Prenatally Diagnosed Isolated Right Aortic Arch: the ARCADE Study

acronym: ARCADE

summary:
The existence of a right aortic arch integrates nosologically into the group of aortic vascular arch anomalies. In the majority of cases, a right aortic arch is associated with cono-truncal congenital heart diseases (CHD), such as tetralogy of Fallot, pulmonary atresia with ventricular septal defect, and truncus arteriosus. Sometimes, a right aortic arch can be isolated, with an incidence of 0.05% to 0.1 %. Therefore, an assessment of the anatomy is necessary because an isolated right aortic arch can be associated with an encircling aortic arch anomaly and may subsequently have a functional repercussion, creating a digestive obstacle (oesophageal compression) and/or a respiratory obstacle (tracheal compression).

Furthermore, indications for surgery in this type of abnormalities are not well-established.

The diagnosis of a vascular artery anomaly is currently mostly made prenatally, with increasing diagnostic accuracy. Indeed, the application of the "3VT view" (e.g. three vessels and tracheae view) in routine prenatal sonographic screening for CHD has contributed to a better identification of such anomalies.

Prenatal diagnosis of an isolated right aortic arch involves the identification of the following aspects: the existence of a left ductus arteriosus may relate to an increased risk of an encircling aortic arch anomaly at birth; the analysis of the different vessels of the aortic arch, which can be difficult because of the fetal circulation and the maternal-fetal conditions of the examination; and the absence of a thymus, which suggests the existence of a genetic anomaly, such as DiGeorge syndrome.

After birth, the evaluation of the functional repercussion of the anomaly remains complex. The incidence of secondary symptoms to encircling abnormalities is estimated at 25%, but varies according to the anomaly: it is very frequent in case of a double aortic arch, variable in case of a right aortic arch with left ductus arteriosus (from 9% to 47% in the literature), absent in case of right aortic arch with right ductus arteriosus. Postnatal echocardiography can only assess the existence of a right aortic arch and check ductus arteriosus closure. The complete anatomical diagnosis of a vascular artery anomaly can only be made by slice cardiac imaging (CT scan or MRI), but in practice these examinations are not routinely performed in the absence of neonatal symptoms.

The aim of this study is to evaluate the accuracy of prenatally diagnosed isolated right aortic arch in terms of anatomy and functional prognosis.

The secondary aims are :

to specify the association of an isolated right aortic arch with a genetic anomaly,
to define the role of CT scan in children prenatally diagnosed with right aortic arch, in terms of diagnosis, prognosis and follow-up,
to evaluate the incidence of respiratory and digestive complications in the first year of life,
to evaluate the indications for surgical management during the first year of life.

time_perspective: Retrospective

ipd_sharing_description: NC


title: Assessment of Survival and Autonomy With Rituximab Plus Chemotherapy or Rituximab Plus Lenalidomide for Elderly Patients With Relapsed Diffuse Large B-cell Lymphoma

acronym: Relyage

summary:
Diffuse large B-cell lymphoma (DLBCL) is the most common type of non-Hodgkin lymphoma. Annual incidence increases with age and achieves more than 30 per 100 000 patients 65 years old or over.

Despite high response rates with conventional regimen as R-CHOP (Rituximab, Cyclophosphamide, Doxorubicin, Vincristine and Prednisone), 30% to 40% of patients develop a relapse or a refractory disease, with a poor prognosis. There is no standard chemotherapy in second line for elderly patients, which are not eligible to receive a salvage treatment by high-dose therapy followed by autologous stem cell transplantation. The median progression-free-survival (PFS) is less than one year with the most commonly used regimens including R-Gemcitabine-Oxaliplatin (R-GEMOX) and R-Bendamustine. One the other side, Rituximab plus Lenalidomide, an immunomodulatory agent, is an active new therapeutic approach, with an efficacy proved in a phase II trial with a patients with a prolonged disease-free-survival of 32 months for responders in patients with a median age of 74 years old. This combination is also efficient in the ABC phenotype DLBCL which is more common in elderly patients.

For elderly patients, a management of the geriatric impairment together with lymphoma is required. Indeed, a comprehensive geriatric assessment detects frailty and vulnerability in elderly with a lymphoma and predicts severe treatment related toxicity, treatment settings and progression free survival. Moreover, geriatric intervention improved outcome, autonomy and quality of life. Functional status, assessed by Activities of patients Daily Living (ADL) is an independent predictive factor for feasibility of chemotherapy in elderly patients with cancer. The mini Data Set of DIALOG group is a new simplified geriatric assessment for oncologist.

lead_sponsor: Centre Hospitalier Universitaire, Amiens


title: Multidisciplinary Development of the Geriatric Core Dataset for Clinical Research in Older Patients With Cancer: A French Initiative With International Survey

acronym: G-CODE

summary:
Older adults with cancer remain underrepresented in cancer clinical trials that establish new standards of care. Geriatric assessment (GA) is defined by geriatricians as a multidimensional interdisciplinary assessment of the general health stat us of the older patient, reviewing the medical, psychosocial, functional and environmental domains. For each domain, several tools are available, but consensus is lacking on which tool to use and the optimal cut-offs or threshold scores. The literature supports the prognostic value of the GA and its utility in weighing the benefits and risks of cancer treatments in older adults. However, GA has not been implemented in routine oncology practice or in cancer clinical trials.

The objective of this project is to develop a set of geriatric data, the Geriatric Core Dataset (G-CODE), to be collected in cancer trials of older patients. The methods rely on a consensus process involving international experts in the field of oncology and geriatrics.

ReferenceType: result

ReferenceCitation: Paillaud E, Soubeyran P, Caillet P, Cudennec T, Brain E, Terret C, Etchepare F, Mourey L, Aparicio T, Pamoukdjian F, Audisio RA, Rostoft S, Hurria A, Bellera C, Mathoulin-Pélissier S; G-CODE collaborators. Multidisciplinary development of the Geriatric Core Dataset for clinical research in older patients with cancer: A French initiative with international survey. Eur J Cancer. 2018 Nov;103:61-68. doi: 10.1016/j.ejca.2018.07.137. Epub 2018 Sep 11.

family: Paillaud

full_name: E. Paillaud

family: Soubeyran

full_name: P. Soubeyran

given: P.

family: Caillet

full_name: P. Caillet

family: Cudennec

full_name: T. Cudennec

family: Brain

full_name: E. Brain

family: Terret

full_name: C. Terret

family: Etchepare

full_name: F. Etchepare

family: Mourey

full_name: L. Mourey

family: Aparicio

full_name: T. Aparicio

family: Pamoukdjian

full_name: F. Pamoukdjian

family: Audisio

full_name: R.A. Audisio

family: Rostoft

full_name: S. Rostoft

family: Hurria

full_name: A. Hurria

family: Bellera

full_name: C. Bellera

family: Mathoulin-Pélissier

full_name: S. Mathoulin-Pélissier

family: Boulahssass

full_name: R. Boulahssass

given: R.

family: De Decker

full_name: L. De Decker

family: Fossey-Diaz

full_name: V. Fossey-Diaz

family: Liuu

full_name: E. Liuu

family: Mertens

full_name: C. Mertens

family: Balardy

full_name: L. Balardy

family: Retornaz

full_name: F. Retornaz

family: Couderc

full_name: A.L. Couderc

family: Rollot-Trad

full_name: F. Rollot-Trad

location_facility: Institut Bergonié, Comprehensive Cancer Center


title: Controlled Comparison of a Traditional Dressing Versus a Biologic Dressing Composed of Fetal Fibroblasts and Keratinocytes in Association With a Collagen Matrix on Skin Donor Sites

acronym: CICAFAST

summary:
Cell-based engineered skin substitutes are promising to treat difficult-to-heal acute and chronic wounds such as large/deep burns, ulcers resistant to conventional therapies or surgical wounds. Cultured autologous epidermal cell-based therapy is used for more than two decades as permanent wound coverage for large burns. Although this technique has been shown to improve outcomes in patients with large burn injuries, its clinical use is limited by the creation of a second wound at the donor site, the three-week delay needed to obtain sufficient amounts of cells, and the absence of a dermal component resulting in low graft take and wound contraction.

Concurrently, allogeneic cell-based engineered skin substitutes have been proposed. Where they offer off-the-shelf temporary wound coverage acting as biologically active dressings releasing growth factors, cytokines and extra cellular matrix components essential for proper wound healing, they are susceptible of immune rejection that is their major weakness Fetal skin, before the third trimester of gestational age, heals rapidly without scar formation conversely to adult skin. Minimal inflammation, specific cytokine and growth factor profiles, and faster and organized deposit and turnover of Extra Cellular Matrix (ECM) components during fetal wound healing have been proposed to explain the absence of scar formation. Because of their low immunogenicity, and their unique regeneration properties, fetal skin cells represent an attractive alternative to the commonly used autologous and allogenic cutaneous grafts.

The investigators developed a new healing dressing constituted by a collagen sponge seeded with a specific ratio of active fetal fibroblasts and keratinocytes producing a variety of wound healing growth factors and cytokines which increase the speed of wound healing, induce an immunotolerant state, with a low inflammatory reaction.

This prospective randomized controlled study aims to compare wound healing of CICAFAST versus conventional treatment (JELONET®) in the treatment of split-thickness skin graft donor site at D8. The patient will be his own control.

ReferenceCitation: Poinas A, Perrot P, Lorant J, Nerrière O, Nguyen JM, Saiagh S, Frenard C, Leduc A, Malard O, Espitalier F, Duteille F, Chiffoleau A, Vrignaud F, Khammari A, Dréno B. CICAFAST: comparison of a biological dressing composed of fetal fibroblasts and keratinocytes on a split-thickness skin graft donor site versus a traditional dressing: a randomized controlled trial. Trials. 2019 Oct 28;20(1):612. doi: 10.1186/s13063-019-3718-4.

family: Poinas

full_name: Alexandra Poinas

given: Alexandra

family: Perrot

full_name: Pierre Perrot

given: Pierre

family: Lorant

full_name: Judith Lorant

given: Judith

family: Nerrière

full_name: Olivier Nerrière

given: Olivier

family: Nguyen

full_name: Jean-Michel Nguyen

given: Jean-Michel

family: Saiagh

full_name: Soraya Saiagh

given: Soraya

family: Frenard

full_name: Cécile Frenard

given: Cécile

family: Leduc

full_name: Audrey Leduc

given: Audrey

family: Malard

full_name: Olivier Malard

family: Espitalier

full_name: Florent Espitalier

given: Florent

family: Duteille

full_name: Franck Duteille

given: Franck

family: Chiffoleau

full_name: Anne Chiffoleau

given: Anne

family: Vrignaud

full_name: Florence Vrignaud

given: Florence

family: Khammari

full_name: Amir Khammari

given: Amir

family: Dréno

full_name: Brigitte Dréno

given: Brigitte

oa_host_type: publisher;repository

evidence: oa journal (via doaj)

host_type: publisher

license: cc-by

license_normalized: cc-by

version: publishedVersion

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

host_type: repository

repository_institution: PubMed Central - Europe PMC

repository_normalized: PubMed Central

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Inria

repository_normalized: HAL

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Diderot


title: Optimization of the Patient Care Pathway in Immuno-oncology

acronym: OPTIMMUNO

summary:
This study compares the care pathway of melanoma patients treated by immunotherapy in two ambulatory care structures. The aim is to measure if a care structure specialized in immuno-oncology could rationalize the care of patients.

This protocol will be based on two different follow-up during the treatment period:

dedicated and coordinated e-follow-up (IUCT-O in Toulouse)
standard follow-up (University Hospital Center in Bordeaux)

Patients will be followed from the first cycle of immunotherapy until 3 months after the initiation treatment.

primary_purpose: Health Services Research

lead_sponsor: Institut Claudius Regaud

location_facility:
Hôpital Saint André, CHU de Bordeaux
Institut claudius regaud IUCT ONCOPOLE


type: Other Identifier

title: Prehospital High-Flow Nasal Oxygen Therapy in Patients With Acute Hypoxemic Respiratory Failure: A Randomized, Open-label, Bi-center, Pilot Study

summary: The purpose of the present project is to compare High-Flow Nasal Oxygen therapy with Standard Oxygen therapy, initiated in the prehospital setting in patients with acute hypoxemia respiratory failure, in terms of oxygenation at arrival to the hospital and need of mechanical ventilation during the subsequent 28 days

ReferenceCitation: Prekker ME, Feemster LC, Hough CL, Carlbom D, Crothers K, Au DH, Rea TD, Seymour CW. The epidemiology and outcome of prehospital respiratory distress. Acad Emerg Med. 2014 May;21(5):543-50. doi: 10.1111/acem.12380.

ReferenceCitation: Kelly AM, Holdgate A, Keijzers G, Klim S, Graham CA, Craig S, Kuan WS, Jones P, Lawoko C, Laribi S; AANZDEM study group. Epidemiology, prehospital care and outcomes of patients arriving by ambulance with dyspnoea: an observational study. Scand J Trauma Resusc Emerg Med. 2016 Sep 22;24(1):113.

ReferenceCitation: Stiell IG, Spaite DW, Field B, Nesbitt LP, Munkley D, Maloney J, Dreyer J, Toohey LL, Campeau T, Dagnone E, Lyver M, Wells GA; OPALS Study Group. Advanced life support for out-of-hospital respiratory distress. N Engl J Med. 2007 May 24;356(21):2156-64.

ReferenceCitation: Fontanari P, Burnet H, Zattara-Hartmann MC, Jammes Y. Changes in airway resistance induced by nasal inhalation of cold dry, dry, or moist air in normal individuals. J Appl Physiol (1985). 1996 Oct;81(4):1739-43.

ReferenceCitation: Sim MA, Dean P, Kinsella J, Black R, Carter R, Hughes M. Performance of oxygen delivery devices when the breathing pattern of respiratory failure is simulated. Anaesthesia. 2008 Sep;63(9):938-40. doi: 10.1111/j.1365-2044.2008.05536.x. Epub 2008 Jun 6.

ReferenceCitation: Li J, Fink JB, Ehrmann S. High-flow nasal cannula for COVID-19 patients: low risk of bio-aerosol dispersion. Eur Respir J. 2020 May 14;55(5). pii: 2000892. doi: 10.1183/13993003.00892-2020. Print 2020 May.

ReferenceCitation: Leonard S, Strasser W, Whittle JS, Volakis LI, DeBellis RJ, Prichard R, Atwood CW Jr, Dungan GC 2nd. Reducing aerosol dispersion by High Flow Therapy in COVID-19: High Resolution Computational Fluid Dynamics Simulations of Particle Behavior during High Velocity Nasal Insufflation with a Simple Surgical Mask. J Am Coll Emerg Physicians Open. 2020 May 29. doi: 10.1002/emp2.12158. [Epub ahead of print]

lead_sponsor: Centre Hospitalier Régional d'Orléans

location_facility:
Brigade des Sapeurs Pompiers de Paris
CHR d'ORLEANS

intervention_type: Device


title: Intra-laryngeal Implant for Treatment of Chronic Aspirations

summary: This study evaluates the medical device Newbreez LD is designed to protect the lower airways from saliva, liquids and food aspirations in tracheotomized patients suffering from chronic aspirations that require specific care and may lead to complications, including inhalation pneumonia.

status: Withdrawn

primary_purpose: Device Feasibility

lead_sponsor: ProTiP Medical

location_facility:
CHU Strasbourg
CHU Toulouse


title: VIrtual REality Glasses for the Enhancement of Acute BRACHYtherapy Tolerance for Endometrial Cancer Patients.

acronym: Vire-Brachy

summary: This randomized phase III multicenter trial aims to evaluate the impact of virtual reality helmets (visual and audio) during VCB in patients treated for endometrial cancer, in terms of pain and anxiety.

primary_purpose: Supportive Care

lead_sponsor: Institut de Cancérologie de la Loire

location_facility: Institut de Cancérologie Lucien Neuwirth


title: Influence of Hyperoxia and Hypobaria on Atelectasis Occurrence and Mitigation of Atelectasis Formation

summary:
The primary aim of this project is to get further knowledge of the physiology of flight atelectasis and its prevention. We seek to: 1) assess whether low levels of positive pressure breathing can prevent atelectasis formation in humans during exposure to hyperoxia and +Gz-accelerations. 2) get further knowledge on the effects of hypobaria on regional ventilation and perfusion.

A secondary aim is to evaluate the effect of anti G-trouser inflation on ventilation and regional perfusion.

primary_purpose: Basic Science

ReferenceCitation: Dussault C, Gontier E, Verret C, Soret M, Boussuges A, Hedenstierna G, Montmerle-Borgdorff S. Hyperoxia and hypergravity are independent risk factors of atelectasis in healthy sitting humans: a pulmonary ultrasound and SPECT/CT study. J Appl Physiol (1985). 2016 Jul 1;121(1):66-77. doi: 10.1152/japplphysiol.00085.2016. Epub 2016 Apr 21.

ReferenceCitation: Borges JB, Hedenstierna G, Bergman JS, Amato MB, Avenel J, Montmerle-Borgdorff S. First-time imaging of effects of inspired oxygen concentration on regional lung volumes and breathing pattern during hypergravity. Eur J Appl Physiol. 2015 Feb;115(2):353-63. doi: 10.1007/s00421-014-3020-9. Epub 2014 Oct 17.

family: Borges

full_name: João Batista Borges

given: João Batista

family: Hedenstierna

full_name: Göran Hedenstierna

given: Göran

family: Bergman

full_name: Jakob S. Bergman

given: Jakob S.

family: Amato

full_name: Marcelo B. P. Amato

given: Marcelo B. P.

family: Avenel

full_name: Jacques Avenel

given: Jacques

family: Montmerle-Borgdorff

full_name: Stéphanie Montmerle-Borgdorff

given: Stéphanie

bso_classification: Biology (fond.)

journal_name: European Journal of Applied Physiology

publisher: Springer Science and Business Media LLC

publisher_dissemination: Springer

publisher_group: Springer

publisher_normalized: Springer

lead_sponsor: Direction Centrale du Service de Santé des Armées

location_facility: Armed Forces Biomedical Research Institute


title: Looking For Genetic and Environmental Risk Factors and Therapeutic Aspects in Cervical Artery Dissections

acronym: CADISP

summary: The main purpose of this study is to look for genetic and environmental risk factors of cervical artery dissections, a major cause of ischemic stroke in young adults, in a large multicenter case-control trial

ReferenceCitation: Engelter ST, Brandt T, Debette S, Caso V, Lichy C, Pezzini A, Abboud S, Bersano A, Dittrich R, Grond-Ginsbach C, Hausser I, Kloss M, Grau AJ, Tatlisumak T, Leys D, Lyrer PA; Cervical Artery Dissection in Ischemic Stroke Patients (CADISP) Study Group. Antiplatelets versus anticoagulation in cervical artery dissection. Stroke. 2007 Sep;38(9):2605-11. Epub 2007 Jul 26. Review.

ReferenceCitation: Debette S, Metso TM, Pezzini A, Engelter ST, Leys D, Lyrer P, Metso AJ, Brandt T, Kloss M, Lichy C, Hausser I, Touzé E, Markus HS, Abboud S, Caso V, Bersano A, Grau A, Altintas A, Amouyel P, Tatlisumak T, Dallongeville J, Grond-Ginsbach C; CADISP-group. CADISP-genetics: an International project searching for genetic risk factors of cervical artery dissections. Int J Stroke. 2009 Jun;4(3):224-30. doi: 10.1111/j.1747-4949.2009.00281.x.

lead_sponsor: Cervical Artery Dissections and Ischemic Stroke Patients - Consortium

location_country:
Italy
Switzerland
Finland
France
Belgium
Argentina
Turkey
Germany
United Kingdom

location_facility: Department of Neurology, University Hospital of Lille

location_facility: Department of Neurology, University Hospital of Munich

location_facility: Department of Neurology, Helsinki University Central Hospital

location_facility: Department of Neurology, University Hospital of Besançon

location_facility: Department of Neurology, University Hospital of Leuven

location_facility: Department of Neurology, University Hospital of Amiens

location_facility: Department of Neurology, University Hospital Pitié-Salpêtrière

location_facility: Department of Neurology, University Hospital of Basel

location_facility: Department of Neurology, Cerrahpasa Medical Faculty, Istanbul University

location_facility: Department of Neurology, University Hospital of Perugia

location_facility: Department of Neurology, University Hospital of Heidelberg

location_facility: Department of Neuroscience, St George's University Hospital of London

location_facility: Department of Neurology, Ospedale Maggiore Policlinico di Milano

location_facility: Department of Neurology, University Hospital Milano-Bicocca

location_facility: Rehabilitation Center, IRCCS Santa Lucia, Roma

location_facility: Department of Neurology, University Hospital Sainte-Anne

location_facility: Department of Neurology, Hospital of Ludwigshafen

location_facility: Department of Neurology, University Hospital of Brussels (ULB)

location_facility: Department of Neurology, University Hospital of Dijon

location_facility: Department of Neurology, University Hospital of Brescia


title: Efficacy Study of the Quadrivalent Human Papilloma Virus (HPV) Vaccine to Prevent Recurrence of External Genital Warts (EGW) in Patients Who Were Cured in the First Place

acronym: CONDYVAC

summary:
External genital warts (EGW) are a frequent disease (typical yearly incidence of 100 to 200 new cases per 100.000 person-years, typical prevalence of 1 to 4% of the sexually active population), with a heavy toll on patients' quality of life: low self-esteem and severe impairment of sexual well-being are common consequences. Treatments are painful and take time to achieve cure because of low complete remission (20 to 60%) and high recurrence rates (10 to 40%, 30% on average). Finding new means to reduce these recurrence rates thus seems justified. Infection with Human Papillomavirus (HPV) is responsible for EGW,other warts and some epithelial cancers. Out of two currently available HPV vaccines (Cervarix and Gardasil®), only Gardasil® is " quadrivalent " i.e. contains virus like particles imparting protection versus 4 genotypes of HPV, 2 of them responsible of most cancers and pre cancers of the cervix (HPV 16 and 18), and 2 for 90% of EGW (HPV 6 and 11). A close to 100 % efficacy of the quadrivalent HPV vaccine (QHV) on prevention of EGW in naive patients has been shown, leading to their near disappearance in the vaccinated population of countries with a good vaccine coverage. Beside this preventive efficacy, literature data also show that HPV vaccines have an up-to-100% protective effect versus recurrence of destroyed precancerous lesions of the cervix in non-naive patients with an up-to-40 month's follow-up. Also, there is anecdotal evidence that they could help treat severe wart conditions. QHV is also safe and well tolerated when used in a preventive manner.

Investigator hypothesis is that QHV could have a protective effect on the recurrence of EGW in patients who achieve complete remission.

The primary objective is to evaluate if the HPV vaccine, as compared to placebo, reduces the relapse rate of external genital warts over a 12 month-period after their first injection.

The primary endpoint is the Relapse-free "survival". Relapse will have to be clinically confirmed.

The secondary objectives are : 1. To assess the improvement of the quality of life of the patients 2. To investigate the clinical tolerance to three doses of HPV vaccine. The secondary endpoints are

Disease relief score as evaluated by patients on a specific questionnaire for Condylomata Acuminata (CECA) and Dermatology Life Quality Index (DLQI) self-administered questionnaires over the treatment and follow-up periods
The clinical tolerance to HPV vaccine will be evaluated by assessment of the percentage of patients with local and/or systemic reactions during the study

This is a National multicenter Phase III comparative, double blind randomized, two-parallel groups clinical trial evaluating the efficacy of Gardasil vaccine versus placebo in EGW population. Patients (300) recently cured of EGW will be enrolled over a 18 month-period and will be randomized in a 1:1 ratio to receive three intra muscular (IM) vaccinations of either Gardasil vaccine (150 subjects) or placebo (150 subjects) :

Group 1: Gardasil (at M0) + Gardasil (at M2) + Gardasil (at M6)
Group 2: Placebo (at M0) + Placebo (at M2) + Placebo (at M6) Subjects meeting all the inclusion criteria and none of the exclusion criteria will be vaccinated by the investigator or designee of the investigational center and will be examined by the investigator or designee 30 minutes post immunization to assess for local and systemic reactions.

All subjects will be followed by the investigators or designee during the study by phone contacts and visits on site. Diary cards will be used after each vaccination to follow the patients.

Number of visits /participant: 9 Schedule of visits : 1 selection visit (V0) , 3 vaccinations scheduled on site at M0, M2 and M6, 3 phone contacts at M1, M3 and M7, 2 clinical follow up visits on site at M9 and M12 + 1 unscheduled visit on site in case of EGW relapse during the study

location_facility:
Hôpital St Louis
GH Cochin - Broca - Hôtel-Dieu,

intervention_type: Biological


type: Registry Identifier

title: Capacity of Multimodal Imaging of Subchondral Bone for the Prediction of Structural Evolution in Knee Osteoarthritis

acronym: MOSART

summary: Predictive factors of osteoarthritis progression are not yet well understood. However, a growing role attaches importance to the subchondral bone. The aim of the present project is to determine predictive factors of progression of osteoarthritis at the knee by a multimodal characterization of subchondral bone by Medical Resonnance Imaging, direct high resolution digitization radiographs and bone texture analysis. At the end of the project, an innovative imaging device, combining semi-automatic softwares for texture analysis, control detection and image registration would be supplied. This will enable on the one hand a more accurate and reproducible way to measure the joint space width of the affected compartment and on the other hand, an assistance to better detect patients at risk of progression of their knee osteoarthritis. Identifying These "progressors" patients might permit their selection in clinical trials at baseline adapted to their severe disease, using for example biologic treatments targeting knee osteoarthritis. The main objective of this study is to analyze the predictive capacities of bone texture parameters measured on the high-resolution radiography of the knee on the structural evolution of the knee osteoarthritis at 3 years.

ReferenceCitation: Janvier T, Jennane R, Valery A, Harrar K, Delplanque M, Lelong C, Loeuille D, Toumi H, Lespessailles E. Subchondral tibial bone texture analysis predicts knee osteoarthritis progression: data from the Osteoarthritis Initiative: Tibial bone texture & knee OA progression. Osteoarthritis Cartilage. 2017 Feb;25(2):259-266. doi: 10.1016/j.joca.2016.10.005. Epub 2016 Oct 11.

ReferenceCitation: Arden N, Richette P, Cooper C, Bruyère O, Abadie E, Branco J, Brandi ML, Berenbaum F, Clerc C, Dennison E, Devogelaer JP, Hochberg M, D'Hooghe P, Herrero-Beaumont G, Kanis JA, Laslop A, Leblanc V, Maggi S, Mautone G, Pelletier JP, Petit-Dop F, Reiter-Niesert S, Rizzoli R, Rovati L, Tajana Messi E, Tsouderos Y, Martel-Pelletier J, Reginster JY. Can We Identify Patients with High Risk of Osteoarthritis Progression Who Will Respond to Treatment? A Focus on Biomarkers and Frailty. Drugs Aging. 2015 Jul;32(7):525-35. doi: 10.1007/s40266-015-0276-7. Review.

ReferenceCitation: Woloszynski T, Podsiadlo P, Stachowiak GW, Kurzynski M, Lohmander LS, Englund M. Prediction of progression of radiographic knee osteoarthritis using tibial trabecular bone texture. Arthritis Rheum. 2012 Mar;64(3):688-95. doi: 10.1002/art.33410.

ReferenceCitation: Guermazi A, Roemer FW, Felson DT, Brandt KD. Motion for debate: osteoarthritis clinical trials have not identified efficacious therapies because traditional imaging outcome measures are inadequate. Arthritis Rheum. 2013 Nov;65(11):2748-58. doi: 10.1002/art.38086.

ReferenceCitation: Kraus VB, Feng S, Wang S, White S, Ainslie M, Brett A, Holmes A, Charles HC. Trabecular morphometry by fractal signature analysis is a novel marker of osteoarthritis progression. Arthritis Rheum. 2009 Dec;60(12):3711-22. doi: 10.1002/art.25012.

location_facility:
Chu Brabois
CHR Orléans

intervention_type: Diagnostic Test


title: Phase I / II Dose Escalation of Oxaliplatin Via a Laparoscopic Approach of Aerosol Pressurized Intraperitoneal Chemotherapy for Nonresectable Peritoneal Metastases of Digestive Cancers (Stomach, Hail and Colorectal)

acronym: PIPOX

summary:
Current curative treatment of digestive peritoneal carcinomatosis consists of complete cytoreduction surgery associated with intraperitoneal chemotherapy. This treatment has important limits: a high morbimortality and the impossibility of repeating the sessions. The majority of patients are therefore treated with systemic chemotherapy, which despite its progress, remains palliative.

Pressurized Intraperitoneal aerosol chemotherapy (PIPAC) has many advantages: under laparoscopy, low morbidity, good intratumoral penetration of cytotoxics, possibility of repeating the sessions and low financial cost.

Therefore, the investigator propose a phase 1 study, in colorectal and stomach cancer, with oxaliplatin doses escalation in Pressurized Intraperitoneal aerosol chemotherapy. It would allow a better tumor response, with potentially few risks and thus improve survival in patients with digestive peritoneal carcinoses, increasing access to cytoreductive surgery.

ReferenceCitation: Dumont F, Passot C, Raoul JL, Kepenekian V, Lelièvre B, Boisdron-Celle M, Hiret S, Senellart H, Pein F, Blanc-Lapierre A, Raimbourg J, Thibaudeau E, Glehen O; BIG-RENAPE Networks. A phase I dose-escalation study of oxaliplatin delivered via a laparoscopic approach using pressurised intraperitoneal aerosol chemotherapy for advanced peritoneal metastases of gastrointestinal tract cancers. Eur J Cancer. 2020 Nov;140:37-44. doi: 10.1016/j.ejca.2020.09.010. Epub 2020 Oct 8.

family: Dumont

full_name: Frédéric Dumont

given: Frédéric

family: Passot

full_name: Christophe Passot

given: Christophe

family: Raoul

full_name: Jean-Luc Raoul

given: Jean-Luc

family: Kepenekian

full_name: Vahan Kepenekian

given: Vahan

family: Lelièvre

full_name: Bénédicte Lelièvre

given: Bénédicte

family: Boisdron-Celle

full_name: Michelle Boisdron-Celle

given: Michelle

family: Hiret

full_name: Sandrine Hiret

given: Sandrine

family: Senellart

full_name: Hélène Senellart

given: Hélène

family: Pein

full_name: Francois Pein

given: Francois

family: Blanc-Lapierre

full_name: Audrey Blanc-Lapierre

family: Raimbourg

full_name: Judith Raimbourg

given: Judith

family: Thibaudeau

full_name: Emilie Thibaudeau

given: Emilie

family: Glehen

full_name: Olivier Glehen

given: Olivier

journal_name: European Journal of Cancer

publisher: Elsevier BV

publisher_dissemination: Elsevier

publisher_group: Elsevier

publisher_normalized: Elsevier

ReferenceCitation: Dumont F, Senellart H, Pein F, Campion L, Glehen O, Goere D, Pocard M, Thibaudeau E. Phase I/II study of oxaliplatin dose escalation via a laparoscopic approach using pressurized aerosol intraperitoneal chemotherapy (PIPOX trial) for nonresectable peritoneal metastases of digestive cancers (stomach, small bowel and colorectal): Rationale and design. Pleura Peritoneum. 2018 Sep 15;3(3):20180120. doi: 10.1515/pp-2018-0120. eCollection 2018 Sep 1.

apc_source: doaj

name: Department of Surgical Oncology, Institut Cancérologique de l’Ouest, Saint Herblain, France

name: Department of Medical Oncology, Institut Cancérologique de l’Ouest, Saint Herblain, France

name: Department of Clinical Research and Innovation, Institut Cancérologique de l’Ouest, Saint Herblain, France

name: Department of Biostatistics and Methodology, Institut Cancérologique de l’Ouest, Saint Herblain, France

family: Campion

full_name: Loic Campion

given: Loic

name: Department of Surgical Oncology, Centre Hospitalier Lyon Sud, Pierre Bénite, France

name: Department of Surgical Oncology, Gustave Roussy Cancer Campus, Villejuif, France

family: Goere

full_name: Diane Goere

given: Diane

name: Department of Digestive and Oncological Surgery, Lariboisière Hospital, AP-HP, Paris 7-Diderot University, Paris, France

family: Pocard

full_name: Marc Pocard

given: Marc

location_facility:
Centre Hospitalier Lyon Sud
ICO René Gauducheau


title: Quantification of microRNAs in Diagnosis of Pulmonary Nodules: Reproducibility Analysis of Intra- and Inter-observer and Inter-laboratory: Project miR-Nod

acronym: miR-Nod

summary: One of the main challenges of thoracic oncology lies in earlier diagnosis of lung cancer to improve survival rate, wich is about 15% at 5 years. This poor prognosis is often linked to late diagnosis. Efforts are being made worldwide to offer testing in patients at risk or earlier diagnosis of lung cancer in order to offer the patient curative treatments. Indeed, supported at the stage of nodule (less than 3 cm lesion), lung cancer is curable by surgery in 80% of patients. Nevertheless, there are many differential diagnoses and access to these lesions is often difficult and risky. In this context, the management of pulmonary nodules, which can be either benign lesions or beginners cancers, is a real challenge for pulmonologists and thoracic oncologists every day: it is important not to disregard a potentially operable nodule and avoiding offer patients invasive procedures for benign nodules. Indeed, many procedures (endoscopy, puncture under scanner, thoracotomy) are made to determine if suspicious nodules are benign or not. In the large National Lung Screening Trial, 28% of the procedures were associated with complications (including 11% classified severe and 16 deaths). It is therefore essential to develop non-invasive tools to refine treatment decisions.

lead_sponsor: University Hospital, Toulouse

location_facility:
University Hospital of la Réunion
University Hospital of Toulouse


title: Multicenter Prospective Cohort of Informal Caregivers in Burgundy-Franche-Comté. ICE Cohort (Informal Caregivers of Elderly)

acronym: ICE

summary:
Medical progress and modification of lifestyles have prolonged life expectancy, despite the development of chronic diseases. The support and care are often provided by a network of informal caregivers composed of family, friends, and neighbors. They became essential to help maintening the elderly persons to live at home. It has been demonstrated that the importance and the diversity of informal tasks may jeopardize their own physical, mental and social well-being.

The aim of the Informal Carers of Elderly Cohort is to define, through a longitudinal study of their life course, the profiles of caregivers of patients with a diagnosis of one of the following diseases: cancer (breast, prostate, colon-rectum), neuro-degenerative diseases (Parkinson's disease, Alzheimer's and similar diseases), neuro-vascular diseases (Cerebrovascular Accident (CVA)), Age-related Macular Degeneration(AMD) and heart disease (heart failure), aged ≥ 60 years old and living in Burgundy or Franche-Comte. By following the different phases of the caregiving relationship from the announcement of the diagnosis, it will be possible to assess the quality of life of caregivers and evaluate the implementation of a pragmatic social action to help informal caregivers through a randomized intervention trial nested in the cohort.

Thanks to an analytical and longitudinal definition of the profiles of informal caregivers, this study could gather precise information on their life courses and their health trajectory by identifying the consequences associated with the concept of their role of aid in care. In addition, the randomized intervention trial will explore the efficacy, in terms of quality of life, and efficiency of a social action to support the caregivers. These data will allow to identify strategies that could be used to improve the existing sources of aid and to propose new approaches to help caregivers. This study will provide the opportunity to identify the most relevant means of support and to give an impulse for new healthcare policies.

ReferenceCitation: Pozet A, Lejeune C, Bonnet M, Dabakuyo S, Dion M, Fagnoni P, Gaimard M, Imbert G, Nerich V, Foubert A, Chotard M, Bonin M, Anota A, Bonnetain F. Evaluation of efficacy and efficiency of a pragmatic intervention by a social worker to support informal caregivers of elderly patients (The ICE Study): study protocol for a randomized controlled trial. Trials. 2016 Nov 3;17(1):531.

location_facility:
CHU de DIJON
Centre Georges François Leclerc
CHRU de Besançon


title: New Strategies to Detect Cancers in Carriers of Mutations in RB1: Blood Tests Based on Tumor-educated Platelets, or Extracellular Vesicles.

acronym: NIRBTEST

summary:
Rationale: Individuals with a cancer predisposition due to a mutation in the paradigm tumor suppressor gene RB1, have a high risk to develop the childhood cancer retinoblastoma (Rb). Biopsies are not possible in Rb, before treatment selection. Heritable Rb patients have also a high risk to develop other types of second primary, either childhood or adult, malignancies (SPMs), notably sarcomas and melanomas. Remarkably, SPMs are now the leading cause of death in heritable-Rb-survivors. Unfortunately, there are no well-developed regular surveillance protocols for SPMs in Rb survivors available right now. Recently, new non-invasive cancer test have been developed, based on either RNA-sequencing data from platelets (ThromboSeq), or on extracellular membrane vesicles (EVs) derived from tumor cells present in blood.

Objective:

Determine the non-cancerous baseline in adult RB1-mutation carriers (heritable-Rb-survivors).
Contribute to the biobanking of blood and cancerous tissues from RB1-mutation carriers with SPMs.
The development of blood-based tests, either platelet or EV-based, for the detection of (the type of) tumors in RB1-mutation carriers.

Study design: Cross-sectional multicenter trial.

Study population:

40 Rb patients (children),
40 controls (children),
153 Rb survivors (adults),
153 controls (adults),
10 Rb survivors with SPM (children/adults).

Main study parameters/endpoints:

Determine the non-cancerous baseline in adult RB1-mutation carriers (heritable-Rb-survivors).
Contribute to the biobanking of blood and cancerous tissues from RB1-mutation carriers with SPMs.

Nature and extent of the burden and risks associated with participation, benefit and group relatedness:

Two blood samples totalling 10ml blood will be collected for every participant. Additionally, a short questionnaire has to be filled in concerning their and their family's cancer history. Blood draws will be done, when participants are already present in the hospital for other appointments, and thus no extra visits are required. For all children, blood will be collected through an already present IV, and so no extra venepuncture is required. Children have to be included because Rb is a tumor only present in this patient group.

time_perspective: Cross-Sectional

lead_sponsor: VU University Medical Center

location_country: Germany France Netherlands

location_facility:
Amsterdam UMC, location VUmc
University Hospital Essen (UHE)
Institute Curie


title: Evaluation of the Beckman Coulter Access HIV Ag/Ab Combo Assay as an Aid in the Diagnosis of HIV-1 and/or HIV-2 Infection: EU Clinical Trial Protocol

summary: The objective of this study is the collection and testing of clinical samples to determine the clinical performance of the Access HIV Ag/Ab Combo assay on the DxI 9000 Access Immunoassay Analyzer

time_perspective: Other

lead_sponsor: Beckman Coulter, Inc.

location_facility: Laboratoire de Virologie, Laboratoire associé au CNR du VIH

location_facility: Etablissement Français du Sang (EFS) Hauts-de-France - Normandie

location_facility: UPR Lille, Établissement français du sang Hauts-de-France - Normandie


title: Confocal Laser Endomicroscopy for Assessment of Neoplasia After Mucosal Ablation or Resection of Gastrointestinal Neoplasia

acronym: CLEAN-MARGIN

summary:
This study focuses on demonstrating the value of probe-based Confocal Laser Endomicroscopy (pCLE) in guiding endoscopic therapeutic procedures in Barrett's Esophagus (BE).

It is a randomized controlled outcomes study including patients already treated for Barrett's Esophagus lesion(s) and undergoing high definition white light endoscopy follow up procedure, with or without pCLE (2 arms will be considered in this study). The procedures will be carried out per standards of practice with appropriately trained physicians.

primary_purpose: Diagnostic

ReferenceCitation: Wallace MB, Crook JE, Saunders M, Lovat L, Coron E, Waxman I, Sharma P, Hwang JH, Banks M, DePreville M, Galmiche JP, Konda V, Diehl NN, Wolfsen HC. Multicenter, randomized, controlled trial of confocal laser endomicroscopy assessment of residual metaplasia after mucosal ablation or resection of GI neoplasia in Barrett's esophagus. Gastrointest Endosc. 2012 Sep;76(3):539-47.e1. doi: 10.1016/j.gie.2012.05.004. Epub 2012 Jun 28.

family: Wallace

full_name: Michael B. Wallace

given: Michael B.

family: Crook

full_name: Julia E. Crook

given: Julia E.

family: Saunders

full_name: Michael Saunders

given: Michael

family: Lovat

full_name: Laurence Lovat

given: Laurence

family: Coron

full_name: Emmanuel Coron

given: Emmanuel

family: Waxman

full_name: Irving Waxman

given: Irving

family: Sharma

full_name: Prateek Sharma

given: Prateek

family: Hwang

full_name: Joo H. Hwang

given: Joo H.

family: Banks

full_name: Matthew Banks

given: Matthew

family: DePreville

full_name: Mathieu DePreville

given: Mathieu

family: Galmiche

full_name: Jean P. Galmiche

given: Jean P.

family: Konda

full_name: Vani Konda

given: Vani

family: Diehl

full_name: Nancy N. Diehl

given: Nancy N.

family: Wolfsen

full_name: Herbert C. Wolfsen

given: Herbert C.

journal_name: Gastrointestinal Endoscopy

lead_sponsor: Mauna Kea Technologies

location_country:
United States
United Kingdom
France

location_facility:
University College London Hospital
Mayo Clinic
Veterans Affairs Hospital
University of Chicago Hospital
Centre Hospitalier Universitaire
University of Washington Medical Center


title: Phase II Trial Assessing the Efficacy of Immuno-Radiation Abscopal Effect in Patients With Metastatic Cancers (IRAM)

acronym: IRAM

summary: The proposed theory is based on combination of radiation therapy with usual targeted therapies capable of ADCC (Antibody-Dependant Cell Cytotoxicity). This association could enhance in a additive/synergistic way the benefic impact of immune system activation on tumor control. Stereotactic Body Radio-Therapy (SBRT) will be combined with the first line chemotherapy for metastatic breast, colorectal or VADS (upper aerodigestive tract) cancers. The IRAM study objective is to highlight a possible abscopal effect of this combination for metastatic cancer patients.

study_start_date_type: Anticipated

location_facility: Institut de Cancérologie Lucien Neuwirth


lead_sponsor: Institut Bergonié

acronym: CIRSARC

location_facility: Institut de Cancérologie de l'Ouest - Site René Gauducheau

type: EudraCT Number

source: euctr

title: Phase III Trial Investigating the Potential Benefit of Intensified Peri-operative Chemotherapy With in High-risk CINSARC Patients With Resectable Soft-tissue SARComas

summary: The primary objective of this trial is to investigate whether the addition of 3 additional neo-adjuvant cycles of chemotherapy (doxorubicin and ifosfamide) to standard management according to the ISG-STS 10-01 study (3 cycles of neoadjuvant doxorubicin and ifosfamide based chemotherapy + surgery +/- radiotherapy) improves the outcome of high-risk CINSARC patients with resectable soft-tissue sarcoma (STS). Primary endpoint is metastatic progression-free survival (M-PFS, after 3 years of follow-up).


title: Lead Time of the Methotrexate Establishment and Vaccinal Protection Against the Pneumococcal Agent in Patients Affected With Rheumatoid Polyarthritis

acronym: VACIMRA

summary: To estimate the rate of immunological answer 1 month after antipneumococcal vaccination by the conjugated vaccine Prevenar13 ® in patients suffered from rheumatoid polyarthritis and who begin a treatement by methotrexate either in the same time, either 1 month later.

lead_sponsor: University Hospital, Montpellier

location_country: Monaco France

location_facility: CHPG Monaco - Hôpital Prince Grace de Monaco


title: Diagnostic Accuracy of the "LLIFT", a Novel Non-invasive Biomarker for the Diagnosis of Non Alcoholic Fatty Liver (NAFL) and SteatoHepatitis (NASH) in a Population With High Risk of Metabolic Syndrome"

acronym: LLIFT

summary:
The NAFLD is the first cause of liver disease worldwide. The severe form of NAFLD, the NASH progresses to cirrhosis and is responsible of liver mortality. The diagnosis of NASH requires liver biopsy that cannot be used for the screening of the disease.

The broad prevalence of the disease limits also the generalization of liver biopsy even for diagnosis. There is an urgent need for the use and the validation of liver diagnosis biomarkers for the diagnosis of NASH.

lead_sponsor: University Hospital, Lille

location_facility:
Chu Amiens Picardie
GHIRCL saint Philibert
CH ARRAS
Ch Valenciennes
Hop Claude Huriez Chu Lille
CH LENS


title: Impact of Early Enteral vs. Parenteral Nutrition on Preservation of Gut Mucosa Integrity in Patients Requiring Mechanical Ventilation and Catecholamines: an Ancillary Study of the NUTRIREA2 Trial (NCT01802099)

summary: To demonstrate that a strategy involving early first-line enteral nutrition is associated with improved preservation of gut mucosa integrity, as assessed based on the plasma citrulline level at H72, compared to a strategy involving early first-line parenteral nutrition

status: Terminated

lead_sponsor: Centre Hospitalier Departemental Vendee

location_facility:
CHU Saint Louis
Centre hospitalier d'Annecy
CHU Tours
CH de Dieppe
CHU Lille
CHU Amiens


title: Impact of Early Enteral vs. Parenteral Nutrition on Risk of Gastric-Content Aspiration in Patients Requiring Mechanical Ventilation and Catecholamines: an Ancillary Study of the NUTRIREA2 Trial (NCT01802099)

summary: To evaluate the impact of enteral nutrition on microaspiration of gastric content and pharyngeal secretions

ReferenceCitation: Nseir S, Le Gouge A, Lascarrou JB, Lacherade JC, Jaillette E, Mira JP, Mercier E, Declercq PL, Sirodot M, Piton G, Tinturier F, Coupez E, Gaudry S, Djibré M, Thevenin D, Pasco J, Balduyck M, Zerimech F, Reignier J. Impact of nutrition route on microaspiration in critically ill patients with shock: a planned ancillary study of the NUTRIREA-2 trial. Crit Care. 2019 Apr 5;23(1):111. doi: 10.1186/s13054-019-2403-z.

family: Nseir

full_name: Saad Nseir

given: Saad

family: Le Gouge

full_name: Amélie Le Gouge

given: Amélie

family: Lascarrou

full_name: Jean-Baptiste Lascarrou

given: Jean-Baptiste

family: Lacherade

full_name: Jean-Claude Lacherade

given: Jean-Claude

family: Jaillette

full_name: Emmanuelle Jaillette

given: Emmanuelle

family: Mira

full_name: Jean-Paul Mira

given: Jean-Paul

family: Mercier

full_name: Emmanuelle Mercier

family: Declercq

full_name: Pierre-Louis Declercq

given: Pierre-Louis

family: Sirodot

full_name: Michel Sirodot

given: Michel

family: Piton

full_name: Gaël Piton

given: Gaël

family: Tinturier

full_name: François Tinturier

given: François

family: Coupez

full_name: Elisabeth Coupez

given: Elisabeth

family: Gaudry

full_name: Stéphane Gaudry

given: Stéphane

family: Djibré

full_name: Michel Djibré

family: Thevenin

full_name: Didier Thevenin

given: Didier

family: Pasco

full_name: Jeremy Pasco

given: Jeremy

family: Balduyck

full_name: Malika Balduyck

given: Malika

family: Zerimech

full_name: Farid Zerimech

given: Farid

family: Reignier

full_name: Jean Reignier

given: Jean

journal_name: Critical Care

repositories_institution: Le Centre pour la Communication Scientifique Directe - HAL - Diderot

repositories_institution: Le Centre pour la Communication Scientifique Directe - HAL - Inria

location_facility:
CHU Saint Louis
CHU Louis Mourier
Centre hospitalier d'Annecy
CHU Tours
CHU Lille
CHU Amiens


title: Impact of Early Palliative Care on Overall Survival of Patients With Metastatic Upper Gastrointestinal Cancers, Treated With First-line Chemotherapy: a Randomized Phase III Trial

summary: This prospective, randomized, open-label and multicenter phase III study is aimed to estimate the survival benefit of Early Palliative Care (EPC) combined with standard oncology care including first-line chemotherapy (experimental arm) over standard oncology care only (standard arm), in patients with metastatic upper gastrointestinal cancers (gastric cancer, pancreatic cancer, biliary tract cancers).

ReferenceCitation: Hutt E, Da Silva A, Bogart E, Le Lay-Diomande S, Pannier D, Delaine-Clisant S, Le Deley MC, Adenis A. Impact of early palliative care on overall survival of patients with metastatic upper gastrointestinal cancers treated with first-line chemotherapy: a randomised phase III trial. BMJ Open. 2018 Jan 23;8(1):e015904. doi: 10.1136/bmjopen-2017-015904. Erratum in: BMJ Open. 2019 May 30;9(5):e015904corr1.

family: Hutt

full_name: Emilie Hutt

given: Emilie

family: Da Silva

full_name: Arlette Da Silva

given: Arlette

family: Bogart

full_name: Emilie Bogart

family: Le Lay-Diomande

full_name: Sara Le Lay-Diomande

given: Sara

family: Pannier

full_name: Diane Pannier

given: Diane

family: Delaine-Clisant

full_name: Stéphanie Delaine-Clisant

given: Stéphanie

family: Le Deley

full_name: Marie-Cécile Le Deley

given: Marie-Cécile

family: Adenis

full_name: Antoine Adenis

given: Antoine

journal_name: BMJ Open

license: cc-by-nc

license_normalized: cc-by-nc

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Inserm

evidence: oa repository (via pmcid lookup)

license_normalized: no license

repositories:
HAL
PubMed Central

publisher: BMJ

publisher_dissemination: British Medical Journal

publisher_group: British Medical Journal

publisher_normalized: British Medical Journal

lead_sponsor: Centre Oscar Lambret

location_facility: Institut de cancérologie de l'Ouest-site PAUL

location_facility: Institut de cancérologie de Lorraine, Nancy

location_facility: Institut de cancérologie de l'Ouest, Nantes

location_facility: CHU de Nantes, CHU - hôpital Nord Laennec,

location_facility: Centre Hospitalier Universitaire de STRASBOURG

location_facility: Institut Curie, site de Saint Cloud, Hopital

location_facility: Centre Georges Francois Leclerc de DIJON


title: A Phase I Placebo-controlled, Double-blind, Dose Escalation Clinical Trial to Evaluate the Safety and Immune Responses of Imcyse's IMCY-0098 in Patients With Recent Onset Type 1 Diabetes

summary: This clinical study will evaluate the safety of an innovative approach expected to be disease-modifying by stopping the auto-immune-mediated destruction of islet β-cells in the pancreas. Three doses of the investigational product will be tested in successive cohorts. Although safety is the first objective of this study, we will gather efficacy data and perform a set of immunological tests to further understand the mechanism of action of this new approach in young adults with recent onset type 1 diabetes.

ReferenceCitation: Carlier VA, VanderElst L, Janssens W, Jacquemin MG, Saint-Remy JM. Increased synapse formation obtained by T cell epitopes containing a CxxC motif in flanking residues convert CD4+ T cells into cytolytic effectors. PLoS One. 2012;7(10):e45366. doi: 10.1371/journal.pone.0045366. Epub 2012 Oct 9.

ReferenceCitation: Malek Abrahimians E, Carlier VA, Vander Elst L, Saint-Remy JM. MHC Class II-Restricted Epitopes Containing an Oxidoreductase Activity Prompt CD4(+) T Cells with Apoptosis-Inducing Properties. Front Immunol. 2015 Sep 2;6:449. doi: 10.3389/fimmu.2015.00449. eCollection 2015. Review.

ReferenceCitation: Malek Abrahimians E, Vander Elst L, Carlier VA, Saint-Remy JM. Thioreductase-Containing Epitopes Inhibit the Development of Type 1 Diabetes in the NOD Mouse Model. Front Immunol. 2016 Mar 2;7:67. doi: 10.3389/fimmu.2016.00067. eCollection 2016. Erratum in: Front Immunol. 2018 Jul 09;9:1600.

lead_sponsor: Imcyse SA

location_country:
Sweden
France
Lithuania
Belgium
Denmark
Germany
United Kingdom

location_facility: St. Bartholomew's Hospital (Barts Health NHS Trust)

location_facility: Cambridge University Hospitals NHS Foundation Trust

location_facility: Oxford University Hospitals NHS Foundation Trust


title: Feasibility of a Cytokine Expression Profile in Immune Cells as an Orientation Tool in Therapeutic Decisions for Auto-inflammatory and Auto-immune Diseases

acronym: IL-MAI

summary: This study will assess the feasibility of using cytokine expression profiles in blood samples as a method for evaluating rheumatoid polyarthritis

lead_sponsor: Centre Hospitalier Universitaire de Nīmes

location_facility:
CHU de Montpellier
CHU Nimes


title: Description of the Functional Evolution of Diffuse Infiltrating Pneumonia Associated With Systemic Scleroderma and Analysis of Associated Factors.

acronym: SCLERO-PID

summary: Diffuse infiltrating pneumonia (DIP) is a severe complication of systemic sclerosis and one of the leading cause of death in this condition. The main objective of this study is to prospectively describe the evolution of DIP overtime and to find prognosis factors.

location_facility:
AH-HP, Hôpital Saint Antoine
Hôpital Claude Huriez, CHU


ReferenceCitation: Burke GAA, Minard-Colin V, Aupérin A, Alexander S, Pillon M, Delgado R, Zsíros J, Uyttebroeck A, Dartigues P, Miles RR, Kazanowska B, Chiang AK, Haouy S, Bollard CM, Csoka M, Wheatley K, Barkauskas DA, Adamson PC, Vassal G, Patte C, Gross TG. Dose-Adjusted Etoposide, Doxorubicin, and Cyclophosphamide With Vincristine and Prednisone Plus Rituximab Therapy in Children and Adolescents With Primary Mediastinal B-Cell Lymphoma: A Multicenter Phase II Trial. J Clin Oncol. 2021 Sep 27:JCO2100920. doi: 10.1200/JCO.21.00920. [Epub ahead of print]

name: Department of Paediatric Haematology, Oncology and Palliative Care, Cambridge University Hospitals NHS Foundation Trust, Addenbrooke's Hospital, Cambridge, United Kingdom

family: Burke

full_name: G. A. Amos Burke

given: G. A. Amos

name: Department of Pediatric and Adolescent Oncology, INSERM 1015, Gustave Roussy, Université Paris-Saclay, Villejuif, France

family: Minard-Colin

full_name: Veronique Minard-Colin

given: Veronique

name: Unit of Biostatistics and Epidemiology, Gustave Roussy, Oncostat 1018 INSERM, Labeled Ligue Contre le Cancer, Université Paris-Saclay, Villejuif, France

family: Aupérin

full_name: Anne Aupérin

given: Anne

name: Division of Haematology/Oncology, Hospital for Sick Children, Toronto, ON, Canada

family: Alexander

full_name: Sarah Alexander

given: Sarah

name: Pediatric Hematology and Oncology, University of Padova, Padova, Italy

family: Pillon

full_name: Marta Pillon

given: Marta

name: Pediatric Hematology and Oncology, University of Valencia, Valencia, Spain

family: Delgado

full_name: Rafael Delgado

given: Rafael

name: Princess Máxima Center for Pediatric Oncology, Utrecht, Netherlands

family: Zsíros

full_name: József Zsíros

given: József

name: Department of Pediatric Hematology and Oncology, University Hospitals Leuven, Leuven, Belgium

family: Uyttebroeck

full_name: Anne Uyttebroeck

name: Department of Biopathology, Gustave Roussy, Université Paris-Saclay, Villejuif, France

family: Dartigues

full_name: Peggy Dartigues

given: Peggy

name: Department of Pathology and ARUP Laboratories and Huntsman Cancer Institute, Salt Lake City, UT

family: Miles

full_name: Rodney R. Miles

given: Rodney R.

name: Department of Pediatric Bone Marrow Transplantation, Oncology, and Hematology, Wroclaw Medical University, Wroclaw, Poland

family: Kazanowska

full_name: Bernarda Kazanowska

given: Bernarda

name: Department of Paediatrics and Adolescent Medicine, Li Ka Shing Faculty of Medicine, Queen Mary Hospital, The University of Hong Kong, Pok Fu Lam, Hong Kong

family: Chiang

full_name: Alan K. Chiang

given: Alan K.

name: Department of Paediatric Haematology, Oncology, CHU Arnaud de Villeneuve, Montpellier, France

family: Haouy

full_name: Stéphanie Haouy

name: Center for Cancer and Immunology Research, Children's National Health System and The George Washington University, Washington, DC

family: Bollard

full_name: Catherine M. Bollard

given: Catherine M.

name: Pediatric Hematology and Oncology, Semmelweis University, Budapest, Hungary

family: Csoka

full_name: Monika Csoka

given: Monika

name: Cancer Research UK Clinical Trials Unit, Institute of Cancer and Genomic Sciences, College of Medical and Dental Sciences, University of Birmingham, Birmingham, United Kingdom

family: Wheatley

full_name: Keith Wheatley

given: Keith

name: Department of Preventive Medicine, Keck School of Medicine of the University of Southern California, Los Angeles, CA

family: Barkauskas

full_name: Donald A. Barkauskas

given: Donald A.

name: Oncology Development & Pediatric Innovation, Sanofi, Cambridge, MA

family: Adamson

full_name: Peter C. Adamson

given: Peter C.

name: Department of Clinical Research, Gustave Roussy, Université Paris-Saclay, Villejuif, France

family: Vassal

full_name: Gilles Vassal

given: Gilles

family: Patte

full_name: Catherine Patte

given: Catherine

name: Department of Pediatrics, Center for Cancer and Blood Diseases, Children's Hospital Colorado, Aurora, CO

family: Gross

full_name: Thomas G. Gross

given: Thomas G.

journal_name: Journal of Clinical Oncology

publisher: American Society of Clinical Oncology (ASCO)

status: Active, not recruiting

lead_sponsor: Gustave Roussy, Cancer Campus, Grand Paris

location_country:
Italy
Netherlands
France
Poland
Hungary
Belgium
Spain
Canada
United Kingdom

acronym: Inter-B-NHL ritux 2010

location_facility: Sociedad Española de Hematología y Oncología Pediátricas

location_facility: Associazione Italiana di Ematologia ed Oncologia Pediatrica

location_facility: 2nd Dept. of Pediatrics Semmelweis Univ.

location_facility: Children Oncology Group Operations centres

title: Intergroup Trial for Children or Adolescents With B-Cell NHL or B-AL: Evaluation of Rituximab Efficacy and Safety in High Risk Patients - Phase II Trial of DA-EPOCH-Rituximab in PMLBL

summary: Phase II trial to determine the efficacy of Dose Adjusted-EPOCH-Rituximab regimen in children and adolescent with primary mediastinal large B cell lymphoma in terms of event free survival.


title: A Randomized, Phase 3 Study of Eryaspase in Combination With Chemotherapy Versus Chemotherapy Alone as 2nd-Line Treatment of Patients With Pancreatic Adenocarcinoma

summary: This is an open-label, multicenter, randomized, Phase 3 study in patients with ductal adenocarcinoma of the pancreas who have failed only one prior line of systemic anti-cancer therapy for advanced pancreatic cancer and have measurable disease.

lead_sponsor: ERYtech Pharma

location_facility: University of Minnesota Health Clinics and Surgery Center

location_facility: University of California Davis Medical Center


title: Assessment of the Reproducibility of the 3 Minutes Sit-to-stand Test in Patients With Idiopathic Pulmonary Fibrosis (IPF)

summary:
This study is designed to evaluate the reproductibility and the performance of the 3 minutes sit-to-stand test in patients with idiopathic pulmonary fibrosis.

To do this, the investigators are recruiting 40 patients with idiopathic pulmonary fibrosis in 2 centers (Grenoble university hospital and Lyon university hospital).

Patients had to achieve an effort test on a cycle ergometer. 2 visits are planned in the hospital. During each visit, patients will perform a 3 minutes sit-to-stand test, a 1 minute sit-to-stand test and a 6 minutes walk test. During the second visit, patients will also perform a 3 minutes sit-to-stand test with measurement of oxygen uptake.

The investigators will then analyse the results by comparing numbers of cycle, functional response and symptoms during the 3 minutes sit-to-stand test of the 2 visits. The investigators will also compare the functional response obtained during the 3 minutes sit-to-stand test, the 1 minute sit-to-stand test and the 6 minutes walk test.

Finally, the investigators will compare the maximal values of oxygen uptake, respiration rate and expired volume obtained during the 3 minutes sit-to-stand test to the effort test on cycle ergometer.

ReferenceCitation: King TE Jr, Pardo A, Selman M. Idiopathic pulmonary fibrosis. Lancet. 2011 Dec 3;378(9807):1949-61. doi: 10.1016/S0140-6736(11)60052-4. Epub 2011 Jun 28. Review.

family: King

full_name: Talmadge E King

given: Talmadge E

suffix: Jr

family: Pardo

full_name: Annie Pardo

given: Annie

family: Selman

full_name: Moisés Selman

given: Moisés

journal_name: The Lancet

title: Idiopathic pulmonary fibrosis

ReferenceCitation: Cottin V, Crestani B, Valeyre D, Wallaert B, Cadranel J, Dalphin JC, Delaval P, Israel-Biet D, Kessler R, Reynaud-Gaubert M, Cordier JF, Aguilaniu B, Bouquillon B, Carré P, Danel C, Faivre JB, Ferreti G, Just N, Kouzan S, Lebargy F, Marchand Adam S, Philippe B, Prévot G, Stach B, Thivolet-Béjui F; French National Reference and Competence Centers for Rare Diseases; Societe de Pneumologies de Langue Francaise. [French practical guidelines for the diagnosis and management of idiopathic pulmonary fibrosis. From the National Reference and the Competence centers for rare diseases and the Société de Pneumologie de Langue Française]. Rev Mal Respir. 2013 Dec;30(10):879-902. doi: 10.1016/j.rmr.2013.09.007. Epub 2013 Oct 25. French. Erratum in: Rev Mal Respir. 2014 Feb;31(2):194-5.

family: Cottin

full_name: V. Cottin

given: V.

family: Crestani

full_name: B. Crestani

given: B.

family: Valeyre

full_name: D. Valeyre

given: D.

family: Wallaert

full_name: B. Wallaert

family: Cadranel

full_name: J. Cadranel

given: J.

family: Dalphin

full_name: J.C. Dalphin

family: Delaval

full_name: P. Delaval

given: P.

family: Israel-Biet

full_name: D. Israel-Biet

family: Kessler

full_name: R. Kessler

given: R.

family: Reynaud-Gaubert

full_name: M. Reynaud-Gaubert

given: M.

family: Cordier

full_name: J.F. Cordier

family: Aguilaniu

full_name: B. Aguilaniu

family: Bouquillon

full_name: B. Bouquillon

family: Carré

full_name: P. Carré

family: Danel

full_name: C. Danel

given: C.

family: Faivre

full_name: J.-B. Faivre

family: Ferreti

full_name: G. Ferreti

given: G.

family: Just

full_name: N. Just

given: N.

family: Kouzan

title: Recommandations pratiques pour le diagnostic et la prise en charge de la fibrose pulmonaire idiopathique. Élaborées par le centre national de référence et les centres de compétence pour les maladies pulmonaires rares sous l’égide de la Société de pneumologie de langue française

ReferenceCitation: Raghu G, Collard HR, Egan JJ, Martinez FJ, Behr J, Brown KK, Colby TV, Cordier JF, Flaherty KR, Lasky JA, Lynch DA, Ryu JH, Swigris JJ, Wells AU, Ancochea J, Bouros D, Carvalho C, Costabel U, Ebina M, Hansell DM, Johkoh T, Kim DS, King TE Jr, Kondoh Y, Myers J, Müller NL, Nicholson AG, Richeldi L, Selman M, Dudden RF, Griss BS, Protzko SL, Schünemann HJ; ATS/ERS/JRS/ALAT Committee on Idiopathic Pulmonary Fibrosis. An official ATS/ERS/JRS/ALAT statement: idiopathic pulmonary fibrosis: evidence-based guidelines for diagnosis and management. Am J Respir Crit Care Med. 2011 Mar 15;183(6):788-824. doi: 10.1164/rccm.2009-040GL.

journal_name: American Journal of Respiratory and Critical Care Medicine

title: An Official ATS/ERS/JRS/ALAT Statement: Idiopathic Pulmonary Fibrosis: Evidence-based Guidelines for Diagnosis and Management

ReferenceCitation: Nalysnyk L, Cid-Ruzafa J, Rotella P, Esser D. Incidence and prevalence of idiopathic pulmonary fibrosis: review of the literature. Eur Respir Rev. 2012 Dec 1;21(126):355-61. doi: 10.1183/09059180.00002512. Review.

ReferenceCitation: Huang XF, Gao F, Xue ZQ, Wang Y, Xu GW. [Multifactorial analysis of survival in breast cancer]. Zhonghua Zhong Liu Za Zhi. 1988 Mar;10(2):117-9. Chinese.

ReferenceCitation: du Bois RM, Weycker D, Albera C, Bradford WZ, Costabel U, Kartashov A, Lancaster L, Noble PW, Sahn SA, Szwarcberg J, Thomeer M, Valeyre D, King TE Jr. Six-minute-walk test in idiopathic pulmonary fibrosis: test validation and minimal clinically important difference. Am J Respir Crit Care Med. 2011 May 1;183(9):1231-7. doi: 10.1164/rccm.201007-1179OC. Epub 2010 Dec 3.

repository_institution: University of Turin - Institutional Research Information System University of Turin

title: Six-Minute-Walk Test in Idiopathic Pulmonary Fibrosis

ReferenceCitation: Nathan SD, du Bois RM, Albera C, Bradford WZ, Costabel U, Kartashov A, Noble PW, Sahn SA, Valeyre D, Weycker D, King TE Jr. Validation of test performance characteristics and minimal clinically important difference of the 6-minute walk test in patients with idiopathic pulmonary fibrosis. Respir Med. 2015 Jul;109(7):914-22. doi: 10.1016/j.rmed.2015.04.008. Epub 2015 Apr 24.

ReferenceCitation: ATS Committee on Proficiency Standards for Clinical Pulmonary Function Laboratories. ATS statement: guidelines for the six-minute walk test. Am J Respir Crit Care Med. 2002 Jul 1;166(1):111-7. Erratum in: Am J Respir Crit Care Med. 2016 May 15;193(10):1185.

ReferenceCitation: Jones CJ, Rikli RE, Beam WC. A 30-s chair-stand test as a measure of lower body strength in community-residing older adults. Res Q Exerc Sport. 1999 Jun;70(2):113-9.

ReferenceCitation: Buatois S, Miljkovic D, Manckoundia P, Gueguen R, Miget P, Vançon G, Perrin P, Benetos A. Five times sit to stand test is a predictor of recurrent falls in healthy community-living subjects aged 65 and older. J Am Geriatr Soc. 2008 Aug;56(8):1575-7. doi: 10.1111/j.1532-5415.2008.01777.x.

journal_name: Journal of the American Geriatrics Society

title: FIVE TIMES SIT TO STAND TEST IS A PREDICTOR OF RECURRENT FALLS IN HEALTHY COMMUNITY-LIVING SUBJECTS AGED 65 AND OLDER

ReferenceCitation: Macfarlane DJ, Chou KL, Cheng YH, Chi I. Validity and normative data for thirty-second chair stand test in elderly community-dwelling Hong Kong Chinese. Am J Hum Biol. 2006 May-Jun;18(3):418-21.

ReferenceCitation: Hill CJ, Denehy L, Holland AE, McDonald CF. Measurement of functional activity in chronic obstructive pulmonary disease: the grocery shelving task. J Cardiopulm Rehabil Prev. 2008 Nov-Dec;28(6):402-9. doi: 10.1097/HCR.0b013e31818c3c65.

journal_name: Journal of Cardiopulmonary Rehabilitation and Prevention

publisher: Ovid Technologies (Wolters Kluwer Health)

title: Measurement of Functional Activity in Chronic Obstructive Pulmonary Disease

ReferenceCitation: Perrault H, Baril J, Henophy S, Rycroft A, Bourbeau J, Maltais F. Paced-walk and step tests to assess exertional dyspnea in COPD. COPD. 2009 Oct;6(5):330-9.

ReferenceCitation: Brodin E, Ljungman S, Sunnerhagen KS. Rising from a chair: a simple screening test for physical function in predialysis patients. Scand J Urol Nephrol. 2008;42(3):293-300. doi: 10.1080/00365590701797556.

name: Department of Physiotherapy, Sahlgrenska University Hospital, Göteborg, Sweden

name: Institute of Neuroscience and Physiology/Rehabilitation Medicine, Sahlgrenska Academy at Göteborg University, Göteborg, Sweden

name: Department of Nephrology, Sahlgrenska University Hospital, Göteborg, Sweden

name: Sunnaas Rehabilitation Hospital and the Medical Faculty, Oslo University, Oslo, Norway

journal_name: Scandinavian Journal of Urology and Nephrology

title: Rising from a chair A simple screening test for physical function in predialysis patients

ReferenceCitation: Ozalevli S, Ozden A, Itil O, Akkoclu A. Comparison of the Sit-to-Stand Test with 6 min walk test in patients with chronic obstructive pulmonary disease. Respir Med. 2007 Feb;101(2):286-93. Epub 2006 Jun 27.

ReferenceCitation: Craig CP, Reynolds SL, Airhart JW, Staab EV. Alterations in immune responses by attenuated Venezuelan equine encephalitis vaccine. I. Adjuvant effect of VEE virus infection in guinea pigs. J Immunol. 1969 May;102(5):1220-7.

ReferenceCitation: Bland JM, Altman DG. Measuring agreement in method comparison studies. Stat Methods Med Res. 1999 Jun;8(2):135-60. Review.

ReferenceCitation: Passing H, Bablok. A new biometrical procedure for testing the equality of measurements from two different analytical methods. Application of linear regression procedures for method comparison studies in clinical chemistry, Part I. J Clin Chem Clin Biochem. 1983 Nov;21(11):709-20.

ReferenceCitation: Carstensen B. Comparing methods of measurement: Extending the LoA by regression. Stat Med. 2010 Feb 10;29(3):401-10. doi: 10.1002/sim.3769.

location_facility:
Groupement Hospitalier Est
CHU Grenoble Alpes


title: Contribution of the ENT Surgeon's Clinical Evaluation to the Contouring of Target Volumes and Organs Eligible for Radiotherapy in Head and Neck Cancers

acronym: CONTOUR

summary: Radiotherapy (RT), surgery and chemotherapy (CT) are treatments for head and neck cancers, used alone or in combination. Conformal RT with Intensity Modulation (IMRT) is currently the reference technique. IMRT requires a precise definition of the target volumes to be treated and the anatomical structures to be protected from irradiation. Most studies of head and neck cancers published in the literature demonstrate the variability in the contouring of the target volumes between radiotherapists. This may have an impact on dosimetry. To date, no studies have evaluated the impact of the ENT surgeon's evaluation in volumes contouring. The aim of this study is to compare the volumes determined by the radiotherapists alone and those determined jointly by the radiotherapists and the ENT surgeon.

lead_sponsor: Fondation Ophtalmologique Adolphe de Rothschild

location_facility: Fondation Ophtalmologique A. de Rothschild


title: Short Duration Therapy of Acute Hepatitis C Genotypes 1 or 4: Efficacy and Tolerability of Grazoprevir 100mg/Elbasvir 50mg During 8 Weeks

acronym: SAHIV

summary: The purpose of this study is to assess the rate of sustained virological response (SVR) 12 weeks after 8-week oral treatment with grazoprevir 100mg/elbasvir 50mg (MRK-combo) in patients with acute hepatitis C genotype1 or 4.

ReferenceCitation: Gambotti L, Batisse D, Colin-de-Verdiere N, Delaroque-Astagneau E, Desenclos JC, Dominguez S, Dupont C, Duval X, Gervais A, Ghosn J, Larsen C, Pol S, Serpaggi J, Simon A, Valantin MA, Velter A; Acute hepatitis C collaborating group. Acute hepatitis C infection in HIV positive men who have sex with men in Paris, France, 2001-2004. Euro Surveill. 2005 May;10(5):115-7.

ReferenceCitation: Fierer DS, Dieterich DT, Fiel MI, Branch AD, Marks KM, Fusco DN, Hsu R, Smith DM, Fierer J. Rapid progression to decompensated cirrhosis, liver transplant, and death in HIV-infected men after primary hepatitis C virus infection. Clin Infect Dis. 2013 Apr;56(7):1038-43. doi: 10.1093/cid/cis1206. Epub 2012 Dec 21.

ReferenceCitation: European AIDS Treatment Network (NEAT) Acute Hepatitis C Infection Consensus Panel. Acute hepatitis C in HIV-infected individuals: recommendations from the European AIDS Treatment Network (NEAT) consensus conference. AIDS. 2011 Feb 20;25(4):399-409. doi: 10.1097/QAD.0b013e328343443b.

ReferenceCitation: Rockstroh JK, Nelson M, Katlama C, Lalezari J, Mallolas J, Bloch M, Matthews GV, Saag MS, Zamor PJ, Orkin C, Gress J, Klopfer S, Shaughnessy M, Wahl J, Nguyen BY, Barr E, Platt HL, Robertson MN, Sulkowski M. Efficacy and safety of grazoprevir (MK-5172) and elbasvir (MK-8742) in patients with hepatitis C virus and HIV co-infection (C-EDGE CO-INFECTION): a non-randomised, open-label trial. Lancet HIV. 2015 Aug;2(8):e319-27. doi: 10.1016/S2352-3018(15)00114-9. Epub 2015 Jul 9. Erratum in: Lancet HIV. 2015 Aug;2(8):e316. Lancet HIV. 2015 Oct;2(10):e416.

ipd_sharing: Yes

ipd_sharing_description: All data are available as IPD. An official request must be made to the Principal Investigator. The request will be reviewed by the Scientific Committee. If approved, data will be exchanged according to European Union General Data Protection Regulation.

lead_sponsor: Institut de Médecine et d'Epidémiologie Appliquée - Fondation Internationale Léon M'Ba

location_facility:
Hôpital Tenon
Hôpital Bichat
CHU de Nice
Hôpital La Pitié-Salpêtrière
CHU de Lyon
Hôpital Saint-Antoine


title: Randomized Double Blind Placebo-controlled Clinical Study : Effect of IBSIUM on the Improvement of Gastro-intestinal Disorders Associated to the Irritable Bowel Syndrome (IBS) With C Phenotype (Predominant-constipation)

acronym: IBS-GO

summary: The main objective is to assess the effect of an 8-week daily supplementation with IbSium® (probiotic yeast Saccharomyces cerevisiae CNCM I-3856) on the improvement gastro-intestinal disorders associated to the type C IBS (constipation predominant).

lead_sponsor: Lesaffre International

location_facility:
Eurofins Optimed
Créabio Rhône Alpes
General pratices
Institut Pasteur de Lille
Biofortis Mérieux NutriSciences

intervention_type: Dietary Supplement


title: Preliminary Feasibility Study of Rehabilitation by Robot "Coach" of Chronic Low Back Pain Patient

acronym: RCOOL

summary:
The objective of KERAAL technological project is to create a new intelligent robot which allows a humanoid robot to record then to show and to follow the progress of rehabilitation sessions proposed by a physiotherapist to a patient, the latter being able to practice without the physiotherapist. The final objective is to stimulate and increase the overseen time of rehabilitation. Poppy robot was chosen as it is able to realize all kind of movements notably movements of the spine with 5 degrees of freedom associated to the several levels of the spine. It will allow to address the population included in the protocol. RCOOL study tries to validate this prototype device as tool of rehabilitation.

The main objective is the feasibility of the supervision by a humanoid robot of a succession of rehabilitation exercises.

RCOOL study is a randomized clinical trial checked under single-blind condition to compare two rehabilitation strategies, one with exercises executed by the patients and supervised by Poppy and the other one with usual rehabilitation protocol.

lead_sponsor: University Hospital, Brest

location_facility: Fondation ILDYS - Service de MPR de l'appareil locomoteur de PERHARIDY