title: Multicenter Randomized Trial of Structured Educational Intervention at the Community Level in Insufficiently Controlled Patients With Type 2 Diabetes in Reunion Island

acronym: ERMIES

summary: Type 2 diabetes has a growing impact on populations and public health worldwide. Clinical trials have clearly demonstrated that a better control of blood glucose level and of other risk factors is efficient in preventing or retarding the complications of the disease. On Reunion island, Type 2 diabetes is present in 18% of population aged 30 or older with a high level of socio-economic deprivation. The hypothesis of the ERMIES study is that a structured group self-management education maintained at the community level for 2 years in patients with insufficiently controlled type 2 diabetes has better metabolic results (as attested by improvement in HbA1c level) at 2 yrs, compared to an initial short term (< 3 months) self-management program, based on the same theoretical basis and framework (learning nests empowerment). A total of 240 adults living in Reunion Island, with type 2 diabetes mellitus with HbA1c ≥ 7.5% on a stable treatment for at least 3 months will be randomly allocated to 2 intervention arms: either a short term (< 3 months) program (1 to 7 thematic 2-hr long sessions depending on individual assessment), or a long term program including the same initial program as 1st arm, but with group self management education sessions, maintained for 2 years (4-monthly assessment, empowerment, and contextual action planning; facultative additional specific thematic sessions being delivered if needed). Medical visits will be held quarterly for the recording of outcome measures (HbA1c, blood pressure, anthropometrics, tobacco consumption, diabetes complications) and yearly for blood glucose, lipids, micro-albuminuria or proteinuria, creatinine clearance, diet and exercise (questionnaires), treatment recording, quality of life, self-efficacy, anxiety and depression scales, and social support.

ReferenceCitation: Debussche X, Balcou-Debussche M, Ballet D, Caroupin-Soupoutevin J. Health literacy in context: struggling to self-manage diabetes - a longitudinal qualitative study. BMJ Open. 2022 Jun 14;12(6):e046759. doi: 10.1136/bmjopen-2020-046759.

license: cc-by-nc

license_normalized: cc-by-nc

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

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Université Paris Descartes

repository_institution: Research Square - Research Square

repository_normalized: Research Square

repositories:
HAL
PubMed Central
Research Square

repositories_concat: HAL;PubMed Central;Research Square

publisher_dissemination: British Medical Journal

ReferenceCitation: Debussche X, Collin F, Fianu A, Balcou-Debussche M, Fouet-Rosiers I, Koleck M, Favier F. Structured self-management education maintained over two years in insufficiently controlled type 2 diabetes patients: the ERMIES randomised trial in Reunion Island. Cardiovasc Diabetol. 2012 Aug 2;11:91. doi: 10.1186/1475-2840-11-91.

lead_sponsor: Centre Hospitalier Universitaire de la Réunion

location_facility: Department of endocrinology, University Hospital Reunion Island - Felix Guyon Site

location_facility: Diabetolgy - UNiversity Hospital Sud Réunion

intervention_type: Behavioral


type: Other Grant/Funding Number

type: Other Identifier

title: Characterization of Clinical, Biological, Morphological and Pharmacological Factors Influencing Occurrence of Dementia or Cognitive Disorders After Stroke

acronym: strokdem

summary: If the risk of dementia occurrence after stroke is well known, few data exist about the factors influencing positively or negatively the developement of cognitive disorders or dementia. The aim of the study is so to determine prospectively the clinical, biological, lesional and pharmacological factors associated with post-stroke dementia by the long-term follow-up of a stroke patient cohort.

study_start_date_type: Actual

status: Unknown status

study_completion_date_type: Anticipated

study_type: Observational

time_perspective: Prospective

enrollment_type: Anticipated

ReferenceType: derived

ReferenceCitation: Ponchel A, Labreuche J, Bombois S, Delmaire C, Bordet R, Henon H. Influence of Medication on Fatigue Six Months after Stroke. Stroke Res Treat. 2016;2016:2410921. doi: 10.1155/2016/2410921. Epub 2016 Jun 19.

oa_colors: green gold

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 - CentraleSupélec

repository_normalized: HAL

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

repository_institution: Université de Lille (University Of Lille) - LillOA

repository_normalized: LillOA (Lille Open Archive)

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - MINES ParisTech

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

evidence: oa repository (via pmcid lookup)

license_normalized: no license

evidence: oa repository (semantic scholar lookup)

version: submittedVersion

repositories:
HAL
LillOA (Lille Open Archive)
PubMed Central
pdfs.semanticscholar.org

repositories_concat: HAL;LillOA (Lille Open Archive);PubMed Central;pdfs.semanticscholar.org

unpaywall_oa_status: gold

publisher_dissemination: Hindawi

lead_sponsor: University Hospital, Lille

sponsor_collaborators:
University Hospital, Lille
Ministry of Health, France

location_facility:
Rouen University Hospital
Lille University Hospital
Amiens University Hospital
Caen University Hospital

lead_sponsor_type: academique

status_simplified: Unknown


title: A Prospective, Multicentre Study Evaluating the Clinical Performance of the ROCC Knee Prosthesis

summary: This observational study intends to collect efficacy and safety data on ROCC Knee system.

status: Terminated

study_completion_date_type: Actual

enrollment_type: Actual

lead_sponsor: Zimmer Biomet

sponsor_collaborators:
Zimmer Biomet
Biomet France SARL

location_country: Spain Austria France

location_facility:
Hospital Torrecardenas
A. ö Landeskrankenhaus Gmunden
Clinique des Fontaines

intervention_type: Device

lead_sponsor_type: industriel


title: A Phase 1B/2A Study to Assess the Safety, Tolerability, Pharmacokinetic and Anti-tumoral Activity of EXS21546 in Combination With a PD-1 Inhibitor in Patients With Advanced Solid Tumours

summary: A phase 1B/2A study to assess the safety, tolerability, pharmacokinetic and anti-tumoral activity of EXS21546 in combination with a PD-1 inhibitor in patients with advanced solid tumours.

study_type: Interventional

primary_purpose: Treatment

ipd_sharing: No

lead_sponsor: Exscientia AI Limited

sponsor_collaborators:
Exscientia AI Limited
Biotrial

location_country: Belgium France

location_facility:
Institute Jules Bordet
Centre GF Leclerc
Institut Bergonie
Centre Eugene Marquis
CHU Mont-Godinne

intervention_type: Drug


title: Role of Geriatric Intervention in Treatment of Older Patients With Cancer : a Phase III Randomized Study (PREPARE)

acronym: PREPARE

summary: Randomized trials have already demonstrated that geriatric intervention was able to improve survival in the general elderly population but only a few have been performed in cancer patients. At the end, these data are not sufficient to consider geriatric intervention as validated in this setting. Case Management, coordinated by a geriatrician and a trained nurse, could improve prognosis of elderly patients with cancer. This approach, can be integrated in daily oncology practice. This strategy will be compared to usual oncological management in a randomized phase III trial.

design_allocation: Randomized

primary_purpose: Other

ReferenceCitation: Soubeyran P, Terret C, Bellera C, Bonnetain F, Jean OS, Galvin A, Chakiba C, Zwolakowski MD, Mathoulin-Pelissier S, Rainfray M. Role of geriatric intervention in the treatment of older patients with cancer: rationale and design of a phase III multicenter trial. BMC Cancer. 2016 Dec 1;16(1):932. doi: 10.1186/s12885-016-2927-4.

repositories_concat: PubMed Central

publisher_dissemination: Springer-Nature

ipd_sharing: Undecided

lead_sponsor: Institut Bergonié

sponsor_collaborators:
Institut Bergonié
Ministry of Health, France

location_facility: Centre Hospitalier Universitaire de Rouen

location_facility: Centre Hospitalier Métropôle Savoie Chambéry

location_facility: Centre Hospitalier Universitaire de Grenoble

location_facility: Centre Hospitalier Intercommunal de Castres Mazamet

location_facility: Centre Hospitalier Universitaire de Clermont-Ferrand

location_facility: Centre Hospitalier Universitaire de Strasbourg

location_facility: Centre Hospitalier Intercommunal de Cornouaille

location_facility: Centre Hospitalier Universitaire de Nantes

location_facility: Centre Hospitalier Universitaire de Caen

location_facility: Centre Hospitalier Universitaire de Martinique

location_facility: Centre Hospitalier Intercommunal de Créteil

location_facility: Centre Hospitalier Universitaire de Rennes

location_facility: Centre Hospitalier Universitaire de Nîmes

location_facility: Centre Hospitalier Universitaire de Lille

location_facility: Centre Hospitalier Universitaire de Tours

location_facility: Institut Bergonié Centre Régional de Lutte Contre le Cancer

location_facility: Centre Hospitalier Privé de Saint Grégoire

location_facility: Centre Hospitalier Universitaire de Poitiers

intervention_type: Other


title: A Multicenter, Prospective, Randomized Controlled Clinical Study of STYLAGE® XXL Versus No-Treatment for Volume Deficiency in the Mid-face

acronym: MidFaceXXL

summary: The primary objective of the study is to demonstrate the superiority of STYLAGE® XXL versus no treatment at 24 weeks after baseline for the creation or restoration of volume deficit in the mid-face.

status: Recruiting

lead_sponsor: Laboratoires Vivacy

collaborators:
Avania B.V.
Canfield Scientific Inc.

sponsor_collaborators:
Laboratoires Vivacy
Avania B.V.
Canfield Scientific Inc.

status_simplified: Ongoing


title: Integrative Molecular Characterization Of MiT Family Translocation Renal Cell Carcinomas (IMCOR)

acronym: IMCOR

summary:
Microphthalmia transcription factor (MiT) family translocation renal cell carcinomas (TRCC) are rare subtypes of kidney cancers, which often arise in children and young adults. TRCC are characterized by translocations affecting transcription factors: Transcription Factor Binding To Immunoglobulin Heavy Constant Mu Enhancer 3 (TFE3) and Transcription Factor EB (TFEB). Little is known about TRCC molecular heterogeneity, in particular their transcriptomic and epigenetic subtype classification. Clinical behavior of TRCC is varying with age and Tumor, Node, Metastasis (TNM) stage. However, the biological basis of this aggressiveness is poorly understood.

PURPOSE: The primary goal of this study is to decipher specific alterations in aggressive TRCC, defined as cases with metastatic dissemination at diagnosis. To tackle this problem, a retrospective cohort of TRCC cases in children and young adults will be created. We will then perform integrative comprehensive multi-omics analysis of these tumors to identify genetic, epigenetic and immune biomarkers associated with metastatic behavior in a training and validation datasets. Comparison of the multi-omics data will be compared to other type of rare Kidney tumors as well as clear-cell renal cell carcinomas

study_start_date_type: Anticipated

status: Not yet recruiting

time_perspective: Retrospective

ReferenceType: background

ReferenceCitation: Herrscher H, Boileve A, Lindner V, Barthelemy P, Hutt E, Pierard L, Kurtz JE, Rioux-Leclercq N, Lang H, Malouf GG. [MiT family translocation renal cell carcinomas: Natural history, molecular features and multidisciplinary management]. Bull Cancer. 2020 Feb;107(2):272-280. doi: 10.1016/j.bulcan.2019.11.010. Epub 2020 Feb 7. French.

lead_sponsor: Institut de cancérologie Strasbourg Europe

collaborators:
National Cancer Institute, France
Ministry of Health, France

location_facility: Réseau Français de Recherche sur le Cancer du Rein (UroCCR)

appel_a_projets: PRTK

region: Grand Est

nom_etablissement: GCS ICANS - ET EXPL.

type_etablissement: GCS

acronyme: IMCOR

titre: Caractérisation Moléculaire Intégrative des Cancers du Rein à Translocation de la Famille MiT.

discipline_principale: cancer

nom_porteur: MALOUF

prenom_porteur: Gabriel


acronym: EKINOx

summary: This study aims at quantifying the performance of kinesthetic stimulation to reduce the burden of obstructive sleep apneas and hypopneas.

status: Completed

lead_sponsor: LivaNova

sponsor_collaborators:
LivaNova
National Research Agency, France

location_facility:
CHU Rennes
University Hospital Tours
Hospital Beziers
University Hospital Grenoble

status_simplified: Completed


type: EudraCT Number

title: A Phase Ib Study of Olaparib With Concomitant Radiotherapy in Locally Advanced/Unresectable Soft-tissue Sarcoma

acronym: RADIOSARP

summary: A phase Ib study of Olaparib with concomitant radiotherapy in locally advanced/unresectable soft-tissue sarcoma.

ReferenceCitation: Vatner R, James CD, Sathiaseelan V, Bondra KM, Kalapurakal JA, Houghton PJ. Radiation therapy and molecular-targeted agents in preclinical testing for immunotherapy, brain tumors, and sarcomas: Opportunities and challenges. Pediatr Blood Cancer. 2021 May;68 Suppl 2:e28439. doi: 10.1002/pbc.28439. Epub 2020 Aug 22.

oa_host_type: publisher

evidence: open (via free article)

repositories_concat: closed

unpaywall_oa_status: bronze

publisher_dissemination: Wiley

sponsor_collaborators:
Institut Bergonié
National Cancer Institute, France

location_facility:
Institut Claudius Regaud - IUCT
Institut Bergonié
Institut du Cancer de Montpellier
Centre Léon Bérard


title: Stereotaxic Irradiation of Hepatocellular Carcinoma : Phase II Study

acronym: CKNO-HEP

summary: Stereotaxic radiation by CyberKnife : 3 X 15 Gy over 8 to 10 days for a total of 45 Gy.

lead_sponsor: Centre Oscar Lambret

sponsor_collaborators:
Centre Oscar Lambret
National Cancer Institute, France

location_facility:
Centre Oscar LAMBRET
Centre François Baclesse
Centre Léon Bérard
Centre Alexis Vautrin

intervention_type: Radiation


title: Evaluation of the Efficacy Rate of Endodontic Treatment at 2 Years After Root Canal Filling With a Ready-to-use Root Canal Sealer PA1704 Versus BioRoot™ RCS: a Randomized Controlled Trial

acronym: OPTIFILL

summary:
The study design is a multicentric randomized controlled non-inferiority trial. 160 subjects (teeth) requiring a primary or a secondary root canal treatment will be enrolled in 2 groups (80 in each group). The aim of the study is to assess the efficacy rate and the safety 2 years after root canal obturation undertaken using a ready-to-use calcium silicate sealer (PA1704) compared to the control calcium silicate sealer BioRoot™ RCS.

Procedures of root canal treatment will be conventional and standardized for all investigational centers. The canals will be cleaned, shaped and then obturated using a calcium silicate sealer (the ready to use sealer PA1704 or BioRoot™ RCS) with a single cone technique or cold lateral condensation of gutta-percha. Follow-up assessments will be conducted at 6, 12 and 24 months in both groups. The performance and safety of the sealer PA1704 will also be evaluated at 3.5 and 5 years after surgery. Retroalveolar radiographs will be taken at each study visit. The preoperative, postoperative and follow-up clinical and radiographic data will be analyzed.

status: Active, not recruiting

lead_sponsor: Septodont

sponsor_collaborators:
Septodont
Slb Pharma

location_facility: Cliniques Universitaires Saint-Luc, Département de Médecine Dentaire et de Stomatologie


title: Evaluation of Non Traditional Cardiovascular Risk Factors in Chronic Kidney Disease Patients Starting Dialysis

summary: To evaluate the relationships between bone mineral markers levels at dialysis start and vascular calcification progression during a 2 year follow up

primary_purpose: Supportive Care

lead_sponsor: University Hospital, Montpellier

location_facility:
CHU Montpellier, Nephrology department
CH Perpignan, Nephrology department
Centre Hémodialyse du Lez
CH Nimes, Nephrology department
AIDER

intervention_type: Procedure


title: Cicatricial Analgesia Catheters Outcome on Bronchopulmonary Infection Number With Sternotomy Cardiac Operated

acronym: STERNOCAT

summary:
Pneumonia occurs frequently in patients undergoing cardiac surgery and allows to increase their mortality. While chest physical therapy plays a crucial role to prevent postoperative pneumoniae, painful mobilization of the sternum after sternotomy limits chest physical therapy. The continuous local anesthetic infusion by multiperforated catheter decreases sternum pain. Because of this optimal pain management, early chest physical therapy could be more efficient and could contribute to decrease the rate of pneumonia.

The aim of this study is to test if management of sternotomy pain using continuous local anesthetic infusion by multiperforated catheter may contribute to decrease the rate of perioperative pneumonia.

ReferenceCitation: Amour J, Cholley B, Ouattara A, Longrois D, Leprince P, Fellahi JL, Riou B, Hariri S, Latremouille C, Remy A, Provenchere S, Carillion A, Achouh P, Labrousse L, Tran Dinh A, Ait Hamou N, Charfeddine A, Lafourcade A, Hajage D, Bougle A; STERNOCAT investigators. The effect of local anesthetic continuous wound infusion for the prevention of postoperative pneumonia after on-pump cardiac surgery with sternotomy: the STERNOCAT randomized clinical trial. Intensive Care Med. 2019 Jan;45(1):33-43. doi: 10.1007/s00134-018-5497-x. Epub 2019 Jan 7.

evidence: open (via free pdf)

lead_sponsor: Assistance Publique - Hôpitaux de Paris

sponsor_collaborators:
Assistance Publique - Hôpitaux de Paris
Baxter Healthcare Corporation
WYM France
Abbott


title: Phase II Study of the Association of Iodobenzylguanidine Meta-I131 (I131 MIBG) and Topotecan in the Treatment of Refractory or Relapsed Metastatic Neuroblastoma

acronym: MIITOP

summary:
RATIONALE: Radioactive drugs, such as iodobenzylguanidine meta-I131, may carry radiation directly to tumor cells and not harm normal cells. Drugs used in chemotherapy, such as topotecan hydrochloride, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. A stem cell transplant may be able to replace the cells that were destroyed by iodobenzylguanidine meta-i131 and topotecan hydrochloride.

PURPOSE: This phase II trial is studying the side effects of iodobenzylguanidine meta-I131 given together with topotecan hydrochloride and to see how well it works in treating young patients with refractory or relapsed metastatic neuroblastoma.

sponsor_collaborators:
Centre Oscar Lambret
National Cancer Institute, France
Novartis Pharmaceuticals

location_facility:
Centre Oscar Lambret
Centre Léon Bérard
Hôpital des Enfants


acronym:
MEVITEM

 MEVITEM

lead_sponsor: Centre Leon Berard

summary:
The purpose of this study is to evaluate the safety of vismodegib in combination with temozolomide (primary objective - phase I) and to estimate the efficacy of vismodegib in combination with temozolomide in adult patients with recurrent, progressive, or refractory medulloblastomas to standard therapy measured by the 6-month progression-free rate (phase II).

This study is an open-label Phase I/II, international, randomized.

38 patients will be included in the study.

ReferenceCitation: Lupi O. Correlations between the Sonic Hedgehog pathway and basal cell carcinoma. Int J Dermatol. 2007 Nov;46(11):1113-7. doi: 10.1111/j.1365-4632.2007.03391.x.

ReferenceCitation: Romer JT, Kimura H, Magdaleno S, Sasai K, Fuller C, Baines H, Connelly M, Stewart CF, Gould S, Rubin LL, Curran T. Suppression of the Shh pathway using a small molecule inhibitor eliminates medulloblastoma in Ptc1(+/-)p53(-/-) mice. Cancer Cell. 2004 Sep;6(3):229-40. doi: 10.1016/j.ccr.2004.08.019.

ReferenceCitation: Yauch RL, Gould SE, Scales SJ, Tang T, Tian H, Ahn CP, Marshall D, Fu L, Januario T, Kallop D, Nannini-Pepe M, Kotkow K, Marsters JC, Rubin LL, de Sauvage FJ. A paracrine requirement for hedgehog signalling in cancer. Nature. 2008 Sep 18;455(7211):406-10. doi: 10.1038/nature07275. Epub 2008 Aug 27.

ReferenceCitation: Cornu P, Chatellier G, Fauchon F, Foncin JF, Faillot T, Dorwling-Carter D, Philippon J. [The prognosis of medulloblastoma in adults]. Neurochirurgie. 1990;36(4):218-24. French.

ReferenceCitation: Coulbois S, Civit T, Grignon Y, Taillandier L, Girard F, Marchal C, Pinelli C, Auque J. [Adult medulloblastoma. Review of 22 patients]. Neurochirurgie. 2001 Feb;47(1):6-12. French.

ReferenceCitation: Giordana MT, Schiffer P, Lanotte M, Girardi P, Chio A. Epidemiology of adult medulloblastoma. Int J Cancer. 1999 Mar 1;80(5):689-92. doi: 10.1002/(sici)1097-0215(19990301)80:53.0.co;2-g.

ReferenceCitation: Brandes AA, Palmisano V, Monfardini S. Medulloblastoma in adults: clinical characteristics and treatment. Cancer Treat Rev. 1999 Feb;25(1):3-12. doi: 10.1053/ctrv.1998.0096.

ReferenceCitation: Chan AW, Tarbell NJ, Black PM, Louis DN, Frosch MP, Ancukiewicz M, Chapman P, Loeffler JS. Adult medulloblastoma: prognostic factors and patterns of relapse. Neurosurgery. 2000 Sep;47(3):623-31; discussion 631-2. doi: 10.1097/00006123-200009000-00018.

ReferenceCitation: del Charco JO, Bolek TW, McCollough WM, Maria BL, Kedar A, Braylan RC, Mickle JP, Buatti JM, Mendenhall NP, Marcus RB Jr. Medulloblastoma: time-dose relationship based on a 30-year review. Int J Radiat Oncol Biol Phys. 1998 Aug 1;42(1):147-54. doi: 10.1016/s0360-3016(98)00197-7.

ReferenceCitation: Duffner PK. Long-term effects of radiation therapy on cognitive and endocrine function in children with leukemia and brain tumors. Neurologist. 2004 Nov;10(6):293-310. doi: 10.1097/01.nrl.0000144287.35993.96.

ReferenceCitation: Padovani L, Sunyach MP, Perol D, Mercier C, Alapetite C, Haie-Meder C, Hoffstetter S, Muracciole X, Kerr C, Wagner JP, Lagrange JL, Maire JP, Cowen D, Frappaz D, Carrie C. Common strategy for adult and pediatric medulloblastoma: a multicenter series of 253 adults. Int J Radiat Oncol Biol Phys. 2007 Jun 1;68(2):433-40. doi: 10.1016/j.ijrobp.2006.12.030.

ReferenceCitation: Abacioglu U, Uzel O, Sengoz M, Turkan S, Ober A. Medulloblastoma in adults: treatment results and prognostic factors. Int J Radiat Oncol Biol Phys. 2002 Nov 1;54(3):855-60. doi: 10.1016/s0360-3016(02)02986-3.

ReferenceCitation: Carrie C, Lasset C, Alapetite C, Haie-Meder C, Hoffstetter S, Demaille MC, Kerr C, Wagner JP, Lagrange JL, Maire JP, et al. Multivariate analysis of prognostic factors in adult patients with medulloblastoma. Retrospective study of 156 patients. Cancer. 1994 Oct 15;74(8):2352-60. doi: 10.1002/1097-0142(19941015)74:83.0.co;2-h.

ReferenceCitation: Evans AE, Jenkin RD, Sposto R, Ortega JA, Wilson CB, Wara W, Ertel IJ, Kramer S, Chang CH, Leikin SL, et al. The treatment of medulloblastoma. Results of a prospective randomized trial of radiation therapy with and without CCNU, vincristine, and prednisone. J Neurosurg. 1990 Apr;72(4):572-82. doi: 10.3171/jns.1990.72.4.0572.

ReferenceCitation: Packer RJ, Sutton LN, Elterman R, Lange B, Goldwein J, Nicholson HS, Mulne L, Boyett J, D'Angio G, Wechsler-Jentzsch K, et al. Outcome for children with medulloblastoma treated with radiation and cisplatin, CCNU, and vincristine chemotherapy. J Neurosurg. 1994 Nov;81(5):690-8. doi: 10.3171/jns.1994.81.5.0690.

ReferenceCitation: Packer RJ, Gajjar A, Vezina G, Rorke-Adams L, Burger PC, Robertson PL, Bayer L, LaFond D, Donahue BR, Marymont MH, Muraszko K, Langston J, Sposto R. Phase III study of craniospinal radiation therapy followed by adjuvant chemotherapy for newly diagnosed average-risk medulloblastoma. J Clin Oncol. 2006 Sep 1;24(25):4202-8. doi: 10.1200/JCO.2006.06.4980.

ReferenceCitation: Tait DM, Thornton-Jones H, Bloom HJ, Lemerle J, Morris-Jones P. Adjuvant chemotherapy for medulloblastoma: the first multi-centre control trial of the International Society of Paediatric Oncology (SIOP I). Eur J Cancer. 1990 Apr;26(4):464-9.

ReferenceCitation: Zeltzer PM, Boyett JM, Finlay JL, Albright AL, Rorke LB, Milstein JM, Allen JC, Stevens KR, Stanley P, Li H, Wisoff JH, Geyer JR, McGuire-Cullen P, Stehbens JA, Shurin SB, Packer RJ. Metastasis stage, adjuvant treatment, and residual tumor are prognostic factors for medulloblastoma in children: conclusions from the Children's Cancer Group 921 randomized phase III study. J Clin Oncol. 1999 Mar;17(3):832-45. doi: 10.1200/JCO.1999.17.3.832.

ReferenceCitation: Riffaud L, Saikali S, Leray E, Hamlat A, Haegelen C, Vauleon E, Lesimple T. Survival and prognostic factors in a series of adults with medulloblastomas. J Neurosurg. 2009 Sep;111(3):478-87. doi: 10.3171/2009.1.JNS081004.

ReferenceCitation: Nicholson HS, Kretschmar CS, Krailo M, Bernstein M, Kadota R, Fort D, Friedman H, Harris MB, Tedeschi-Blok N, Mazewski C, Sato J, Reaman GH. Phase 2 study of temozolomide in children and adolescents with recurrent central nervous system tumors: a report from the Children's Oncology Group. Cancer. 2007 Oct 1;110(7):1542-50. doi: 10.1002/cncr.22961.

ReferenceCitation: Barone G, Maurizi P, Tamburrini G, Riccardi R. Role of temozolomide in pediatric brain tumors. Childs Nerv Syst. 2006 Jul;22(7):652-61. doi: 10.1007/s00381-006-0081-z. Epub 2006 Mar 25.

ReferenceCitation: Kenney AM, Rowitch DH. Sonic hedgehog promotes G(1) cyclin expression and sustained cell cycle progression in mammalian neuronal precursors. Mol Cell Biol. 2000 Dec;20(23):9055-67. doi: 10.1128/MCB.20.23.9055-9067.2000.

ReferenceCitation: Ingham PW, McMahon AP. Hedgehog signaling in animal development: paradigms and principles. Genes Dev. 2001 Dec 1;15(23):3059-87. doi: 10.1101/gad.938601. No abstract available.

ReferenceCitation: Hooper JE, Scott MP. Communicating with Hedgehogs. Nat Rev Mol Cell Biol. 2005 Apr;6(4):306-17. doi: 10.1038/nrm1622.

ReferenceCitation: Ferretti E, De Smaele E, Di Marcotullio L, Screpanti I, Gulino A. Hedgehog checkpoints in medulloblastoma: the chromosome 17p deletion paradigm. Trends Mol Med. 2005 Dec;11(12):537-45. doi: 10.1016/j.molmed.2005.10.005. Epub 2005 Nov 14.

ReferenceCitation: Scales SJ, de Sauvage FJ. Mechanisms of Hedgehog pathway activation in cancer and implications for therapy. Trends Pharmacol Sci. 2009 Jun;30(6):303-12. doi: 10.1016/j.tips.2009.03.007. Epub 2009 May 13.

ReferenceCitation: Rubin LL, de Sauvage FJ. Targeting the Hedgehog pathway in cancer. Nat Rev Drug Discov. 2006 Dec;5(12):1026-33. doi: 10.1038/nrd2086.

ReferenceCitation: Pasca di Magliano M, Hebrok M. Hedgehog signalling in cancer formation and maintenance. Nat Rev Cancer. 2003 Dec;3(12):903-11. doi: 10.1038/nrc1229. No abstract available.

ReferenceCitation: Von Hoff DD, LoRusso PM, Rudin CM, Reddy JC, Yauch RL, Tibes R, Weiss GJ, Borad MJ, Hann CL, Brahmer JR, Mackey HM, Lum BL, Darbonne WC, Marsters JC Jr, de Sauvage FJ, Low JA. Inhibition of the hedgehog pathway in advanced basal-cell carcinoma. N Engl J Med. 2009 Sep 17;361(12):1164-72. doi: 10.1056/NEJMoa0905360. Epub 2009 Sep 2.

ReferenceCitation: Rudin CM, Hann CL, Laterra J, Yauch RL, Callahan CA, Fu L, Holcomb T, Stinson J, Gould SE, Coleman B, LoRusso PM, Von Hoff DD, de Sauvage FJ, Low JA. Treatment of medulloblastoma with hedgehog pathway inhibitor GDC-0449. N Engl J Med. 2009 Sep 17;361(12):1173-8. doi: 10.1056/NEJMoa0902903. Epub 2009 Sep 2.

ReferenceCitation: Ellison DW, Dalton J, Kocak M, Nicholson SL, Fraga C, Neale G, Kenney AM, Brat DJ, Perry A, Yong WH, Taylor RE, Bailey S, Clifford SC, Gilbertson RJ. Medulloblastoma: clinicopathological correlates of SHH, WNT, and non-SHH/WNT molecular subgroups. Acta Neuropathol. 2011 Mar;121(3):381-96. doi: 10.1007/s00401-011-0800-8. Epub 2011 Jan 26.

ReferenceCitation: Schwalbe EC, Lindsey JC, Straughton D, Hogg TL, Cole M, Megahed H, Ryan SL, Lusher ME, Taylor MD, Gilbertson RJ, Ellison DW, Bailey S, Clifford SC. Rapid diagnosis of medulloblastoma molecular subgroups. Clin Cancer Res. 2011 Apr 1;17(7):1883-94. doi: 10.1158/1078-0432.CCR-10-2210. Epub 2011 Feb 16.

ReferenceCitation: Steg A, Vickers SM, Eloubeidi M, Wang W, Eltoum IA, Grizzle WE, Saif MW, Lobuglio AF, Frost AR, Johnson MR. Hedgehog pathway expression in heterogeneous pancreatic adenocarcinoma: implications for the molecular analysis of clinically available biopsies. Diagn Mol Pathol. 2007 Dec;16(4):229-37. doi: 10.1097/PDM.0b013e31811edc7e.

sponsor_collaborators:
Centre Leon Berard
Ministry of Health, France

location_facility: Centre Hospitalier Universitaire Vaudois (CHUV)

location_facility: Institut de Cancérologie de l'Ouest - Paul Papin

location_facility: Institut Claudius Régaud (iuct-oncopole)

location_facility: University College London Hospital - Mount Vernon Cancer Centre - Mount Vernon hospital

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

title: An International, Randomized, Open-label Phase I/II Study of Vismodegib in Combination With Temozolomide Versus Temozolomide Alone in Adult Patients With Recurrent or Refractory Medulloblastomas Presenting an Activation of the Sonic Hedgehog (SHH) Pathway

source: euctr

location_country:
Italy
Switzerland
United Kingdom
France


title: Muscular Rehabilitation by Eccentric Exercise After Severe COVID-19 Infection: Research Protocol for Randomized Controlled Trial (CovExc)

acronym: CovExc

summary:
With the COVID-19 pandemic, the number of patients to be treated in rehabilitation increased .

Hospitalization for severe infection can induce muscular atrophy and muscular dysfunction that persists for several months and rehabilitation capacities may be exceeded.

Exercises in eccentric mode could be performed, inducing greater muscular hypertrophy, muscle strength, power and speed than concentric exercises.

The goal of this study was to compare functional recovery at 2 months after a training program in eccentric and concentric mode after severe COVID-19.

An effective rehabilitation could help reduce costs and duration of care.

ReferenceCitation: Zhang P, Li J, Liu H, Han N, Ju J, Kou Y, Chen L, Jiang M, Pan F, Zheng Y, Gao Z, Jiang B. Long-term bone and lung consequences associated with hospital-acquired severe acute respiratory syndrome: a 15-year follow-up from a prospective cohort study. Bone Res. 2020 Feb 14;8:8. doi: 10.1038/s41413-020-0084-5. eCollection 2020. Erratum In: Bone Res. 2020 Sep 21;8:34.

ReferenceCitation: Puthucheary ZA, Rawal J, McPhail M, Connolly B, Ratnayake G, Chan P, Hopkinson NS, Phadke R, Dew T, Sidhu PS, Velloso C, Seymour J, Agley CC, Selby A, Limb M, Edwards LM, Smith K, Rowlerson A, Rennie MJ, Moxham J, Harridge SD, Hart N, Montgomery HE. Acute skeletal muscle wasting in critical illness. JAMA. 2013 Oct 16;310(15):1591-600. doi: 10.1001/jama.2013.278481. Erratum In: JAMA. 2014 Feb 12;311(6):625. Padhke, Rahul [corrected to Phadke, Rahul].

ReferenceCitation: Connolly B, Salisbury L, O'Neill B, Geneen L, Douiri A, Grocott MP, Hart N, Walsh TS, Blackwood B. Exercise rehabilitation following intensive care unit discharge for recovery from critical illness: executive summary of a Cochrane Collaboration systematic review. J Cachexia Sarcopenia Muscle. 2016 Dec;7(5):520-526. doi: 10.1002/jcsm.12146. Epub 2016 Sep 16.

ReferenceCitation: van Zanten ARH, De Waele E, Wischmeyer PE. Nutrition therapy and critical illness: practical guidance for the ICU, post-ICU, and long-term convalescence phases. Crit Care. 2019 Nov 21;23(1):368. doi: 10.1186/s13054-019-2657-5.

ReferenceCitation: Wu Y, Xu X, Chen Z, Duan J, Hashimoto K, Yang L, Liu C, Yang C. Nervous system involvement after infection with COVID-19 and other coronaviruses. Brain Behav Immun. 2020 Jul;87:18-22. doi: 10.1016/j.bbi.2020.03.031. Epub 2020 Mar 30.

ReferenceCitation: Bailey P, Thomsen GE, Spuhler VJ, Blair R, Jewkes J, Bezdjian L, Veale K, Rodriquez L, Hopkins RO. Early activity is feasible and safe in respiratory failure patients. Crit Care Med. 2007 Jan;35(1):139-45. doi: 10.1097/01.CCM.0000251130.69568.87.

ReferenceCitation: Needham DM. Mobilizing patients in the intensive care unit: improving neuromuscular weakness and physical function. JAMA. 2008 Oct 8;300(14):1685-90. doi: 10.1001/jama.300.14.1685.

lead_sponsor: University Hospital, Clermont-Ferrand

sponsor_collaborators:
University Hospital, Clermont-Ferrand
GIRCI Auvergne Rhône-Alpes
Ministry of Health, France

location_facility:
CHU de Clermont-Ferrand
CHU de Saint-Etienne
CHU de Dijon


title: Alcohol and Tobacco Consumption in Patients With Head and Neck or Lung Cancer : Interest of Integrating the Addiction Treatment to the Initial Cancer Treatment Program

summary: This is a multicenter, interventional, randomized study among patients with a first lung or head & neck cancer who are still active smokers ± alcohol misusers.The study will aim to compare the systematic implementation of an addiction treatment program initiated at hospital and integrated to the initial cancer treatment program (Arm A), versus the as-usual procedure, which consists in recommendations to follow an addiction treatment program (Arm B)

primary_purpose: Health Services Research

collaborators: Centre Régional de Référence en Cancérologie

location_facility: CHRU of Lille : Albert Calmette Hospital


title: Prevalence and Risk Factors for Persistent Tobacco or Alcohol Use Over the First Year of a First Lung or Head and Neck Cancer

acronym: ALTAK

summary: This is an multicenter study for preventive and therapeutic strategies for patients with head and neck cancer

ReferenceCitation: Vannimenus C, Bricout H, Le Rouzic O, Mouawad F, Chevalier D, Dansin E, Rotsaert L, Lefebvre G, Cottencin O, Porte H, Scherpereel A, El Fahsi A, Richard F, Rolland B; ALTAK Study Group. Compared characteristics of current vs. past smokers at the time of diagnosis of a first-time lung or head and neck cancer: a cross-sectional study. BMC Cancer. 2018 Apr 3;18(1):372. doi: 10.1186/s12885-018-4253-5.

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

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

repositories:
HAL
PubMed Central

repositories_concat: HAL;PubMed Central

sponsor_collaborators: Centre Régional de Référence en Cancérologie

location_facility: Centre Hospitalier Régional et Universitaire - Hopital HURIEZ

location_facility: Centre Hospitalier Régional et Universitaire - Hopital CALMETTE


title: Cell Therapy in Critical Limb Ischemia

acronym: BALI

summary:
BALI (Bone marrow Autograft in Limb Ischemia) is a randomized double-blind trial comparing implantation of bone marrow - mononuclear cells versus placebo in patients presenting with critical leg ischemia and no surgical option.

The main end point is the survival without major amputation 6 months after implantation.

Biological studies are performed on bone marrow mononuclear cells (BM-MNC) to evaluate their angiogenic properties.

design_allocation: Non-Randomized

lead_sponsor: CHU de Reims

sponsor_collaborators:
CHU de Reims
Etablissement Français du Sang

location_facility:
HEGP
CHU
Chu Reims
Centre Hospitalier
Chu Strasbourg


title: A Randomized, Multicentric, Double Blind Study to Assess the Efficacy of Xylka® (Baclofen) at the Target Dosage of 180mg/Day Compared to Placebo, for Maintenance of Abstinence in Alcohol Dependent Patients

acronym: ALPADIR

summary: The purpose of the study is to assess the efficacy of Xylka® (baclofen) compared to placebo on continuous abstinence rate during 20 weeks of treatment, after withdrawal, in alcohol dependent patients receiving Brenda therapy sessions.

ReferenceCitation: Braillon A, Naudet F. Pharmacotherapies for Alcohol Use Disorder: Over Both Sides of the Atlantic Ocean. Mayo Clin Proc. 2020 Oct;95(10):2294-2295. doi: 10.1016/j.mayocp.2020.08.005. No abstract available.

publisher_dissemination: Elsevier

lead_sponsor: Ethypharm

location_facility:
Hopital Beaujon
Hopital de la Croix Rousse
Hopital Bichat Claude Bernard
Hopital Villemin
Centre hospitalier intercommunal
Hopital de la Fraternité
Hopital Sainte Marguerite
Hopital Fernand Widal
Hopital Saint Anne
Hopital Cochin
Hopital Michallon
Hopital Paul Brousse
CHRU
Centre hospitalier
CHU
CSAPA
Hopital Pontchaillou
Hopital Brabois
Hopital René Muret


title: Trajectories of FEV1 After Lung Transplantation: Determinants and Clinical Outcomes

acronym: TRAJLUNG

summary: For individuals with ESLD, lung transplantation is the best, or only treatment option with increased pulmonary function and quality of life. The forced expiratory volume in one second (FEV1) is the standard to monitor the lung function after transplantation. The goal of this study is to identify and validate the FEV1 trajectories after lung transplantation, as well as their determinants and outcomes, using an international cohort of lung recipients.

status: Enrolling by invitation

ReferenceCitation: GBD Chronic Respiratory Disease Collaborators. Prevalence and attributable health burden of chronic respiratory diseases, 1990-2017: a systematic analysis for the Global Burden of Disease Study 2017. Lancet Respir Med. 2020 Jun;8(6):585-596. doi: 10.1016/S2213-2600(20)30105-3.

ReferenceCitation: Li X, Cao X, Guo M, Xie M, Liu X. Trends and risk factors of mortality and disability adjusted life years for chronic respiratory diseases from 1990 to 2017: systematic analysis for the Global Burden of Disease Study 2017. BMJ. 2020 Feb 19;368:m234. doi: 10.1136/bmj.m234. Erratum In: BMJ. 2020 Aug 6;370:m3150.

ReferenceCitation: Brakema EA, Tabyshova A, van der Kleij RMJJ, Sooronbaev T, Lionis C, Anastasaki M, An PL, Nguyen LT, Kirenga B, Walusimbi S, Postma MJ, Chavannes NH, van Boven JFM; FRESH AIR collaborators. The socioeconomic burden of chronic lung disease in low-resource settings across the globe - an observational FRESH AIR study. Respir Res. 2019 Dec 21;20(1):291. doi: 10.1186/s12931-019-1255-z.

ReferenceCitation: Perch M, Hayes D Jr, Cherikh WS, Zuckermann A, Harhay MO, Hsich E, Potena L, Sadavarte A, Lindblad K, Singh TP, Stehlik J; International Society for Heart and Lung Transplantation. The International Thoracic Organ Transplant Registry of the International Society for Heart and Lung Transplantation: Thirty-ninth adult lung transplantation report-2022; focus on lung transplant recipients with chronic obstructive pulmonary disease. J Heart Lung Transplant. 2022 Oct;41(10):1335-1347. doi: 10.1016/j.healun.2022.08.007. Epub 2022 Aug 20. No abstract available.

ipd_sharing: Yes

ipd_sharing_description: Deidentified data may be shared for research purpose upon reasonable request.

lead_sponsor: Paris Translational Research Center for Organ Transplantation


title: Single-center Pathophysiological Study of the Role of Inflammation, Changes in the Intestinal Epithelial Barrier and the Intestinal Microbiota in Parkinson's Disease

acronym: IBIM-Park

summary:
Converging evidence from the literature suggests that digestive inflammation may play a role in the development of Parkinson's disease (PD). The investigators showed in the laboratory in a pilot study that PD patients have digestive inflammation and that the level of inflammation was inversely related to the length of the disease course. This digestive inflammation could be at the origin of an increased intestinal permeability in a subpopulation of parkinsonian patients, cause or consequence of modifications of the intestinal microbiota, thus offering a potential portal of entry for a pathogen according to Braak's theory. To opponents of this theory, it could also reflect the spread of inflammation from the Central nervous System to the Enteral Nervous System (ENS), via the brain-gut axis.

Investigators' hypothesis is that digestive inflammation occurs very early in Parkinson's disease and that it is associated with hyperpermeability of the intestinal epithelial barrier and a change in the intestinal microbiota composition. The investigators propose to study the inflammation markers in the ENS of patients with a pre-motor form of PD (idiopathic Rapid Eye Movement (REM) sleep behavior disorder, n = 20), early-stage PD (<5 years, without dopatherapy, n = 20), more advanced PD (> 5 years, n = 20) and control subjects (n = 20), on colonic biopsies taken during a rectosigmoidoscopy or a coloscopy. Intestinal permeability will be measured by ex-vivo techniques (in a Ussing chamber), the composition of the microbiota will be established by sequencing 16s RNA and the lesional load of phosphorylated alpha-synuclein will be evaluated by immunohistochemistry. All of these parameters will be correlated with clinical data on the severity of PD: duration of development, age, total Unified Parkinson's Disease Rating Scale (UPDRS) motor score and axial sub-score, cognitive tests (Montreal Cognitive Assessment, MoCA), existence of a probable idiopathic REM sleep behavior disorder (REM Sleep Behavior Disorder Screening Questionnaire RBDSQ), olfactory tests, complaint of dysautonomia (SCales for Outcomes in Parkinson's disease - autonomic dysfunction, SCOPA-Aut).

The analysis of inflammation markers, the intestinal barrier and the microbiota could be a first step making it possible to formulate physiopathological hypotheses on the development of PD, to propose predictive biomarkers of the disease and its severity and to design early interventions in the hope of modifying the evolutionary course of the pathological process.

primary_purpose: Basic Science

lead_sponsor: Nantes University Hospital

sponsor_collaborators:
Nantes University Hospital
France Parkinson Association
Luxia Scientific
INSERM - TENS - UMR 1235


title: Assessment of Tele-expertise for the Interpretation of MRI Among Neonates With High Risk of Neurological Sequelae

acronym: Matrix Neonat

summary: The purpose of the study is to determine whether tele-expertise would be more effective and more cost-effective for the Interpretation of MRI Among Neonates with high risk of neurological sequelae

ReferenceCitation: Larroque B, Ancel PY, Marret S, Marchand L, Andre M, Arnaud C, Pierrat V, Roze JC, Messer J, Thiriez G, Burguet A, Picaud JC, Breart G, Kaminski M; EPIPAGE Study group. Neurodevelopmental disabilities and special care of 5-year-old children born before 33 weeks of gestation (the EPIPAGE study): a longitudinal cohort study. Lancet. 2008 Mar 8;371(9615):813-20. doi: 10.1016/S0140-6736(08)60380-3.

ReferenceCitation: Kidholm K, Ekeland AG, Jensen LK, Rasmussen J, Pedersen CD, Bowes A, Flottorp SA, Bech M. A model for assessment of telemedicine applications: mast. Int J Technol Assess Health Care. 2012 Jan;28(1):44-51. doi: 10.1017/S0266462311000638.

collaborators: Agence Regionale de Sante d'Ile de France

location_facility: Service de radiopédiatrie. Hôpital Necker

location_facility: Service de Radiopédiatrie. Hôpital Trousseau

location_facility: Service de radiopédiatrie - Hôpital Robert Debré


title: Polymorphism of the IgH Locus Regulatory Region as a Prognostic Factor During Immune Pathologies.

acronym: PRIERR

summary:
The investigators previously showed that both antibody class switching (from IgM to IgG, IgA or IgE) and antibody secretion are controlled by a polymorphic "3' regulatory region" (3'RR) of the immunoglobulin heavy chain (IgH) locus. Alleles of the 3'RR have shown influences on the severity and progression of IgA nephropathy (IgAN) (with an over-representation of the B allele among patients with severe kidney IgA deposits). Allele B also constitutes a risk factor for celiac disease, herpetiform dermatitis, psoriasis and rheumatoid arthritis. Since the 3'RR now appears as a crucial regulator of Ig production, we wish to check whether its genetic polymorphism might influence not only the occurrence of immunopathologic processes involving class-switched antibody deregulated production but also the severity of such diseases or the time course of their progression. We wish to focus on two conditions involving class-switched antibodies: on one hand the severe forms of IgE hypersensitivities, and on the other hand a disease involving pathogenic IgA and for which the prognosis is currently very difficult to predict at the onset of the disease: Henoch-Schonlein purpura (HSP).

Regarding hypersensitivities, the diversity of their clinical manifestations prompt us to focus on homogeneous groups of patients and we thus wish to concentrate on two groups of patients who are frequently referred to the hospital: severe allergies to Hymenoptera venoms and severe food allergies related to peanut allergens sensitization. These groups will be built by considering multiple clinical criteria (clinical history, severity of the manifestations, positive skin tests, and positive oral provocation tests for peanut allergens…) and biological criteria authenticating the mechanisms of the disease (high specific serum IgE, demonstration of specific basophil activation by the allergen…).

In parallel to the study in patients, we will include a large cohort of healthy controls (400 individuals), in order to be able to decipher whether correlations can be seen between:

IgH 3'RR genotypes
The serum accumulation of the various Ig classes, including IgG subclasses, IgA (which are sometimes depicted as protective, sometimes as tolerogenic and anti-inflammatory) and IgE (highly pro-inflammatory and responsible for hypersensitivities)
IgG allotypes (with 6 frequent IgG haplotypes known in human and previously reported as correlated with varying levels of IgG and IgE production in normal individuals).

lead_sponsor: University Hospital, Limoges

collaborators: Institut National de la Santé Et de la Recherche Médicale, France

location_facility:
Pediatric
Pneumology
Nephrology
Clinical Investigation Center

intervention_type: Biological


title: MultiPoint Pacing Mapping Study

summary: The purpose of this study is to characterize left ventricular acute hemodynamic and electrical responses during cardiac resynchronization therapy (CRT) with different Multipoint Pacing (MPP) settings, and assess the relationship between electrical activation patterns and hemodynamic measurements during these pacing settings.

lead_sponsor: Abbott Medical Devices

location_country:
Germany
United Kingdom
France

location_facility:
Herzzentrum Dresden Universitätsklinik
CHU Pontchaillou
Kerckhoff-Klinik GmbH
St. Thomas Hospital


title: First Description of a Severe Ivermectin Neurotoxicity in a Child Carrying ABCB1 Nonsense Mutations.

summary:
The study report a unique case of severe intoxication in a child treated with oral ivermectin to prevent scabies infection. The ABCB1 gene sequencing found the child compound heterozygote for two nonsense mutations, one in each gene copy. The child had inherited from each parent one of the alleles. Each mutation generate a predicted truncated protein that likely lead to ABCB1 loss of function, and the undesirable effects observed.

The study report a unique case of severe intoxication in a child treated with oral ivermectin to prevent scabies infection. The ABCB1 gene sequencing found the child compound heterozygote for two nonsense mutations, one in each gene copy. The child had inherited from each parent one of the alleles. Each mutation generate a predicted truncated protein that likely lead to ABCB1 loss of function, and the undesirable effects observed.

While in some animals, nonsense ABCB1 mutations can lead to neurotoxicity of several ABCB1-substrate drugs, in humans, ivermectin was considered to have an especially high margin of safety, and nonsense mutations have never been reported before, nor has the neurotoxicity of ivermectin apparently caused by these two mutations never been reported before.

This discovery is of critical importance for the child, since it dictates that clinicians would need to optimize any ABCB1 substrate-based therapy in the future. More generally, such information must be brought to the attention of clinicians' medics, and in particular infectious disease specialists, pediatricians, and general practitioners.

It points the importance of pharmacovigilance, and the benefit of pharmacogenomic genotyping in well-defined phenotype, still too rarely considered in clinical practice before the implementation of a drug treatment.

This work results from a multidisciplinary approach, combining several areas of expertise in clinical pediatrics, pharmacology, biology, and bioinformatics.

ipd_sharing_description: NC

collaborators: Université Paris-Saclay, Gif-sur-Yvette, France


title: Noninvasive Hemodynamics for MultiPoint(TM) Pacing Programming in Cardiac Resynchronization Therapy Patients

summary: The purpose of this study is to evaluate noninvasive hemodynamics with MultiPoint™ Pacing (MPP) and biventricular (BiV) pacing under various vector combinations and paced delays in patients receiving cardiac resynchronization therapy (CRT).

location_country: Italy Austria France

location_facility:
CHU Rennes
Fondazione IRCCS Policlinico San Matteo
Medizinische Universität Graz
Niguarda Hospital


title: Open Label, Uncontrolled Study of XRP9881 in Combination With Trastuzumab (Herceptin®) in Patients With HER2 Positive Metastatic Breast Cancer (MBC)

summary:
The primary objective of the study is to assess the activity of XRP9881 in combination with trastuzumab.

The secondary objectives are safety and pharmacokinetic interaction

lead_sponsor: Sanofi

location_country: Sweden Switzerland Belgium France


title: Assessment of Teleconsulting in Nursing Homes

acronym: EVLINE

summary: The purpose of this study is to determine whether teleconsulting would be effective and cost-effective by reducing the patients transportations and the use of emergency units for nursing home residents requiring emergent or elective care.

ReferenceCitation: Charrier N, Zarca K, Durand-Zaleski I, Calinaud C; ARS Ile de France telemedicine group. Efficacy and cost effectiveness of telemedicine for improving access to care in the Paris region: study protocols for eight trials. BMC Health Serv Res. 2016 Feb 8;16:45. doi: 10.1186/s12913-016-1281-1.

sponsor_collaborators: Agence Regionale de Sante d'Ile de France

location_facility:
Résidence La Cerisaie
Résidence Saint Rémy
Résidence Les Pastoureaux
Résidence Val de France
Résidence Le Sequoia
Résidence Klarene
Résidence du Vexin
Résidence les Noues
Résidence la Chanterelle


title: Evaluation of Calcium Homeostasis and Mitochondrial Function in Skeletal Muscle in Subjects With Heart Failure

summary: The aim of this project is to investigate the impact of heart failure (HF) on calcium homeostasis, mitochondrial function and oxydative stress in human skeletal muscle. The role playing by circulating factors such as cytokines and catecholamines will also be evaluated. 24 HF patients wiil be enrolled in the study: 12 male volunteers with a fraction of ejection ≥ 50% and 12 male volunteers with a fraction of ejection ≤ 35%. They will be compared to 12 sedentary healthy male volunteers, matched on age and physical activity.

collaborators: Institut de Recherches Internationales Servier

sponsor_collaborators: Institut National de la Santé Et de la Recherche Médicale, France

location_facility: physiologie clinique, hopital Arnaud de Villeneuve, 371 avenue du Doyen G;Giraud


title: A Phase II Study Evaluating the Efficacy/Safety of Lenalidomide With or Without Epoetin Beta in Transfusion-dependent ESA-resistant Patients With IPSS Low- and Intermediate-1 Risk Myelodysplastic Syndromes Without Chromosome 5 Abnormality.

summary:
The goal of the present study is to assess, through a randomized phase II trial, the efficacy and safety of Lenalidomide with or without Epoetin beta in transfusion-dependent, ESA-resistant, IPSS low and intermediate-1 risk MDS patients without chromosome 5 abnormality.

Patients will receive either Lenalidomide alone or Lenalidomide and Epoetin beta for 4 months. Responders will be eligible for maintenance treatment with cycles identical to the first cycles, until relapse occurs or until unacceptable toxicity.

ReferenceCitation: Chesnais V, Renneville A, Toma A, Lambert J, Passet M, Dumont F, Chevret S, Lejeune J, Raimbault A, Stamatoullas A, Rose C, Beyne-Rauzy O, Delaunay J, Solary E, Fenaux P, Dreyfus F, Preudhomme C, Kosmider O, Fontenay M; Groupe Francophone des Myelodysplasies. Effect of lenalidomide treatment on clonal architecture of myelodysplastic syndromes without 5q deletion. Blood. 2016 Feb 11;127(6):749-60. doi: 10.1182/blood-2015-04-640128. Epub 2015 Dec 1.

oa_host_type: repository

unpaywall_oa_status: green

publisher_dissemination: American Society of Hematology

lead_sponsor: Groupe Francophone des Myelodysplasies

collaborators:
Celgene
Roche Pharma AG

sponsor_collaborators:
Groupe Francophone des Myelodysplasies
Celgene
Roche Pharma AG

location_country: Monaco France

location_facility: Hematology Dpt, CH d'Avignon-305 rue Follereau-

location_facility: Hematology Dpt, Service d'Hématologie Clinique

location_facility: Hematology Dpt, Centre Hospitalier Lyon Sud

location_facility: Hematology Dpt, Hôpital la pitié-Salpétrière

location_facility: Hematology Dpt, Centre Hospitalier de la région d'Annecy


title: Idiopathic Chronic Thrombocytopenia of Undetermined Significance : Pathogenesis and Biomarker

acronym: ICTUS

summary: It is a translational research study with mechanistical objectives and including biological samples of patients with thrombocytopenia

lead_sponsor: University Hospital, Bordeaux

location_facility: Immunopathologie Clinique - Hôpital Saint Louis - AP HP

location_facility: service de médecine interne et maladies infectieuses - Groupe hospitalier Sud

location_facility: Service des maladies du sang - Hôpital Haut-Lévêque - avenue de Magellan

location_facility: Chirurgie cardiaque - Hôpital Haut Lévêque - CHU de Bordeaux


title: Cerebral Neuroinflammation During Major Depressive Episode: Multicentric Comparative Study.

acronym: InflaDep

summary: the investigators make the following assumptions: 1) neuroinflammation in MDD can be measured by the [18 F ] DPA- 714 ; 2) it is accompanied by anatomical and functional changes in the frontal subcortical loops, strongly involved in MDD ; 3) neuroinflammation in patients might be a biomarker related to resistance to treatment in patients with MDD. If this assumptions are validated, then this study will enable a better understanding of the neuroinflammatory processes. This breakthrough could have a long term therapeutic impact, helping to target more specifically antidepressant drugs with anti-inflammatory action and / or drugs targeting neuroinflammation.

primary_purpose: Diagnostic

ReferenceCitation: Sartorius N. The economic and social burden of depression. J Clin Psychiatry. 2001;62 Suppl 15:8-11.

ReferenceCitation: Bakish D. New standard of depression treatment: remission and full recovery. J Clin Psychiatry. 2001;62 Suppl 26:5-9.

ReferenceCitation: Papakostas GI, Petersen T, Mahal Y, Mischoulon D, Nierenberg AA, Fava M. Quality of life assessments in major depressive disorder: a review of the literature. Gen Hosp Psychiatry. 2004 Jan-Feb;26(1):13-7. doi: 10.1016/j.genhosppsych.2003.07.004.

ReferenceCitation: Schildkraut JJ, Schanberg SM, Breese GR, Kopin IJ. Norepinephrine metabolism and drugs used in the affective disorders: a possible mechanism of action. Am J Psychiatry. 1967 Nov;124(5):600-8. doi: 10.1176/ajp.124.5.600. No abstract available.

ReferenceCitation: Maes M, Noto C, Brietzke E. Omics-based depression and inflammation research. Braz J Psychiatry. 2015 Jan-Mar;37(1):1-2. doi: 10.1590/1516-4446-2015-3609. No abstract available.

ReferenceCitation: Hasler G, van der Veen JW, Tumonis T, Meyers N, Shen J, Drevets WC. Reduced prefrontal glutamate/glutamine and gamma-aminobutyric acid levels in major depression determined using proton magnetic resonance spectroscopy. Arch Gen Psychiatry. 2007 Feb;64(2):193-200. doi: 10.1001/archpsyc.64.2.193.

ReferenceCitation: Deschwanden A, Karolewicz B, Feyissa AM, Treyer V, Ametamey SM, Johayem A, Burger C, Auberson YP, Sovago J, Stockmeier CA, Buck A, Hasler G. Reduced metabotropic glutamate receptor 5 density in major depression determined by [(11)C]ABP688 PET and postmortem study. Am J Psychiatry. 2011 Jul;168(7):727-34. doi: 10.1176/appi.ajp.2011.09111607. Epub 2011 Apr 15.

ReferenceCitation: Entsuah AR, Huang H, Thase ME. Response and remission rates in different subpopulations with major depressive disorder administered venlafaxine, selective serotonin reuptake inhibitors, or placebo. J Clin Psychiatry. 2001 Nov;62(11):869-77. doi: 10.4088/jcp.v62n1106.

ReferenceCitation: Blumberg HP, Kaufman J, Martin A, Whiteman R, Zhang JH, Gore JC, Charney DS, Krystal JH, Peterson BS. Amygdala and hippocampal volumes in adolescents and adults with bipolar disorder. Arch Gen Psychiatry. 2003 Dec;60(12):1201-8. doi: 10.1001/archpsyc.60.12.1201.

ReferenceCitation: Stone VE, Baron-Cohen S, Calder A, Keane J, Young A. Acquired theory of mind impairments in individuals with bilateral amygdala lesions. Neuropsychologia. 2003;41(2):209-20. doi: 10.1016/s0028-3932(02)00151-3.

ReferenceCitation: Yrondi A, Aouizerate B, El-Hage W, Moliere F, Thalamas C, Delcourt N, Sporer M, Taib S, Schmitt L, Arlicot N, Meligne D, Sommet A, Salabert AS, Guillaume S, Courtet P, Galtier F, Mariano-Goulart D, Champfleur NM, Bars EL, Desmidt T, Lemaire M, Camus V, Santiago-Ribeiro MJ, Cottier JP, Fernandez P, Meyer M, Dousset V, Doumy O, Delhaye D, Capuron L, Leboyer M, Haffen E, Peran P, Payoux P, Arbus C. Assessment of Translocator Protein Density, as Marker of Neuroinflammation, in Major Depressive Disorder: A Pilot, Multicenter, Comparative, Controlled, Brain PET Study (INFLADEP Study). Front Psychiatry. 2018 Jul 24;9:326. doi: 10.3389/fpsyt.2018.00326. eCollection 2018.

repository_institution: Universite de Bordeaux - Oskar-Bordeaux

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

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

repositories:
HAL
PubMed Central
oskar-bordeaux.fr

repositories_concat: HAL;PubMed Central;oskar-bordeaux.fr

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

publisher_dissemination: Frontiers

lead_sponsor: University Hospital, Toulouse

location_facility: Clinique Psychiatrique Universitaire CHRU Tours

intervention_type: Diagnostic Test

appel_a_projets: PHRCI

region: Occitanie

nom_etablissement: CHU TOULOUSE

type_etablissement: CH

acronyme: InflaDep

titre: Neuroinflammation cérébrale au cours d'un épisode dépressif caractérisé : étude multicentrique, comparative avec groupe contrôle

discipline_principale: psychiatrie, dépression

nom_porteur: YRONDI

prenom_porteur: Antoine


title: Placental Insufficiency Screening During First Trimester by a Combination of Uterine Artery Dopppler, Maternal PlGF and sFLT-1 in Hight Risk Population

summary: To assess the role of uterine artery and maternal serum PlGf and sflt-1 and their combination in screening for pre-eclampsia and small -for-gestational age (SGA) fetuses at 12-14 weeks of gestation

lead_sponsor: University Hospital, Tours

location_facility: Olympe de Gouges Women Health Centre, Bretonneau University Hospital

location_facility: Hospital of Blois -Service de Gynécologie-Obstétrique

location_facility: CHRU Hôpital Hôtel-Dieu Département Gynécologie Obstétrique


title: The Foot in Your Nose Study: Links Between Nasal Staphylococcus Aureus Colonies and Diabetic Foot Lesion Infections

summary: The presence of S aureus in the nasal passages of diabetic patients may be a risk factor for diabetic foot lesion infections. Our aim is to compare the genetic profiles of S aureus strains found in the noses and on the foot lesions of diabetic patients. The investigators are also studying the virulence of these strains, the prevalance of S aureus at either site, and whether or not the quantity of S aureus found in the nose affects the risk for infection in foot lesions. The investigators also use this study to test the sensitivity and specificity of the GeneXpert system.

lead_sponsor: Centre Hospitalier Universitaire de Nīmes

location_facility: CHU de Nîmes - Hôpital Universitaire Carémeau

location_facility: CHU de Nîmes - Hôpital Universitaire de Réadaptation du Grau du Roi


title: Pharmacokinetic and Imaging Optimization Study of Pretargeted Immuno-PET Using the Anti-CEA x Anti-HSG TF2 Bispecific Antibody and 68Ga-IMP-288 Peptide in Patients With Recurrences of Medullary Thyroid Carcinoma.

acronym: iTEP-CMT

summary: The aim of this study is to optimize pretargeting parameters using pharmacokinetic and imaging data for immuno-PET using anti-CEA x anti-HSG TF2 BsMAb and 150 MBq of 68Ga-IMP-288 peptide in MTC patients with abnormal Ct serum level after initial complete surgery and at least one abnormal lesion

location_facility: Institut de Cancérologie de l'ouest, René Gauducheau


title: Randomized Controlled Multicentre Trial to Quantify the Benefits of Biomarkers in Routine Patient Care in Kidney Transplant Recipients" EU-TRAIN IMPACT Trial

acronym: EUTRAIN IMPACT

summary: The investigator hypothesize that the combined use of (1) non-invasive biomarkers in peripheral blood predicting anti-donor immunological activation or quiescence (2) interactive and actionable data analytics delivered at the bedside will promote safe clinical follow-up of kidney transplant patients with less need for invasive and induced risk surveillance by allograft protocol biopsies to assess allograft rejection in clinically stable kidney transplant patients. It is therefore proposed an European, multicenter, prospective randomized comparing two strategies of follow-up: in the first, biopsies are guided by biomarkers, in the second one, a routine biopsy is performed at M3. In both groups, a biopsy is performed at M12 and whenever considered necessary by the clinician.

location_country: Germany Spain Switzerland France

location_facility:
Geneva University Hospitals
Bellvitge University Hospital
Nantes Hospital
Charité-Universitätsmedizin, Berlin
Vall d'Hebron Hospital
Charité-Universitätsmedizin,
Necker Hospital, Paris
Saint-Louis Hospital, Paris


title: Explorations of the Normal Neural Behavioral and Pathological Bases of Metacognition

acronym: METASENS

summary:
Metacognition is the ability to introspect and report one's own mental states, or in other words to know how much one knows. It allows us to form a sense of confidence about decisions one makes in daily life, so one can commit to one option if our confidence is high, or seek for more evidence before commitment if our confidence is low. Although this function is crucial to behave adequately in a complex environment, confidence judgments are not always optimal. Notably, individuals with schizophrenia are prone to overconfidence in errors and underconfidence in correct answers. In schizophrenia, confidence is less correlated with performance compared to controls.

These aspects are held to be at the origin of delusions, disorganization, poor insight into illness and into cognitive deficit and poor social functioning.

Our study aims at identifying the cognitive and neural processes involved in metacognitive deficits in schizophrenia. Participants will perform metacognitive judgments on a low-level perceptual task (visual motion discrimination). Participants will do the first-order perceptual task by clicking on the correct answer with a mouse. During the first order task completion, the investigators will record several behavioral, physiological and neural variables. Then, participants will perform the metacognitive task with a visual analog scale.

The study will address four research questions:

Q1: is schizophrenia associated with a decrease in metacognitive efficiency? Is the metacognitive deficit due to under- or over-confidence?
Q2: is the metacognitive impairment reflected at a decisional level as measured by behavioral variables (mouse tracking and reaction times)?
Q3: which physiological markers (EEG, skin conductance, heart rate) are predictors of metacognitive efficiency in individuals with schizophrenia and healthy controls?
Q4: which clinical symptoms correlate with metacognitive deficits?

The investigators make several hypotheses related to the previous research questions:

Q1: the investigators expect metacognitive deficits in schizophrenia, based on results from several studies using both qualitative and quantitative measures. The investigators will rule out that quantitative deficits are not confounded with impairments in type 1 performance, with a generalized cognitive deficit in schizophrenia (lower premorbid and current Intelligence Quotient (IQ), and deficits in executive functioning and particularly in planning and working memory abilities), with depression or with statistical flaws during analysis of confidence.
Q2: the investigators expect behavioral cues (mouse tracking and reaction times) to be less correlated with confidence in patients vs. controls. The investigators thus make the hypothesis that the metacognitive deficit in schizophrenia may stem from an inability to integrate pre-decisional cues while performing an explicit metacognitive judgment.
Q3: the investigators expect physiological cues (EEG with Error-Related Negativity, Lateralized Readiness Potential and alpha suppression, and arousal of the autonomic nervous system with skin conductance and heart rate ) to be less correlated with confidence in patients vs. controls.
Q4: based on previous findings, the investigators expect that several clinical dimensions of schizophrenia may correlate with metacognitive performance. The metacognitive deficit would be greater for patients with high levels of positive and disorganized symptoms, and greater for patients with low levels of clinical and cognitive insight, and low levels of social functioning.

time_perspective: Cross-Sectional

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lead_sponsor: Versailles Hospital

collaborators: Centre National de la Recherche Scientifique, France

location_facility:
Centre Hospitalier de Versailles
CH Alpes Isère
CHU Grenoble


lead_sponsor: ANRS, Emerging Infectious Diseases

summary: The trial is an open-label, multicenter, prospective, randomized trial in 2 parallel groups, evaluating at W48 the non inferiority of antiretroviral dual therapy taken 4 consecutive days per week versus antiretroviral dual therapy 7/7 days per week in HIV-1 infected patients with controlled viral load under antiretroviral dual therapy.

ReferenceCitation: Fischer M, Hafner R, Schneider C, Trkola A, Joos B, Joller H, Hirschel B, Weber R, Gunthard HF; Swiss HIV Cohort Study. HIV RNA in plasma rebounds within days during structured treatment interruptions. AIDS. 2003 Jan 24;17(2):195-9. doi: 10.1097/00002030-200301240-00009.

ReferenceCitation: Vergis EN, Paterson DL, Wagener MM, Swindells S, Singh N. Dyslipidaemia in HIV-infected patients: association with adherence to potent antiretroviral therapy. Int J STD AIDS. 2001 Jul;12(7):463-8. doi: 10.1258/0956462011923507.

ReferenceCitation: Magalhaes MG, Greenberg B, Hansen H, Glick M. Comorbidities in older patients with HIV: a retrospective study. J Am Dent Assoc. 2007 Nov;138(11):1468-75. doi: 10.14219/jada.archive.2007.0083.

ReferenceCitation: Ananworanich J, Nuesch R, Cote HC, Kerr SJ, Hill A, Jupimai T, Laopraynak N, Saenawat S, Ruxrungtham K, Hirschel B. Changes in metabolic toxicity after switching from stavudine/didanosine to tenofovir/lamivudine--a Staccato trial substudy. J Antimicrob Chemother. 2008 Jun;61(6):1340-3. doi: 10.1093/jac/dkn097. Epub 2008 Mar 12.

ReferenceCitation: Ferry JA, Sohani AR, Longtine JA, Schwartz RA, Harris NL. HHV8-positive, EBV-positive Hodgkin lymphoma-like large B-cell lymphoma and HHV8-positive intravascular large B-cell lymphoma. Mod Pathol. 2009 May;22(5):618-26. doi: 10.1038/modpathol.2009.36. Epub 2009 Mar 13.

ReferenceCitation: Ho JE, Hsue PY. Cardiovascular manifestations of HIV infection. Heart. 2009 Jul;95(14):1193-202. doi: 10.1136/hrt.2008.161463. No abstract available.

ReferenceCitation: Edelman EJ, Gordon KS, Glover J, McNicholl IR, Fiellin DA, Justice AC. The next therapeutic challenge in HIV: polypharmacy. Drugs Aging. 2013 Aug;30(8):613-28. doi: 10.1007/s40266-013-0093-9.

ReferenceCitation: Flandre P, Raffi F, Descamps D, Calvez V, Peytavin G, Meiffredy V, Harel M, Hazebrouck S, Pialoux G, Aboulker JP, Brun Vezinet F. Final analysis of the Trilege induction-maintenance trial: results at 18 months. AIDS. 2002 Mar 8;16(4):561-8. doi: 10.1097/00002030-200203080-00007.

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ReferenceCitation: Arribas JR, Girard PM, Landman R, Pich J, Mallolas J, Martinez-Rebollar M, Zamora FX, Estrada V, Crespo M, Podzamczer D, Portilla J, Dronda F, Iribarren JA, Domingo P, Pulido F, Montero M, Knobel H, Cabie A, Weiss L, Gatell JM; OLE/RIS-EST13 Study Group. Dual treatment with lopinavir-ritonavir plus lamivudine versus triple treatment with lopinavir-ritonavir plus lamivudine or emtricitabine and a second nucleos(t)ide reverse transcriptase inhibitor for maintenance of HIV-1 viral suppression (OLE): a randomised, open-label, non-inferiority trial. Lancet Infect Dis. 2015 Jul;15(7):785-92. doi: 10.1016/S1473-3099(15)00096-1. Epub 2015 Jun 7. Erratum In: Lancet Infect Dis. 2015 Aug;15(8):875.

ReferenceCitation: Perez-Molina JA, Rubio R, Rivero A, Pasquau J, Suarez-Lozano I, Riera M, Estebanez M, Palacios R, Sanz-Moreno J, Troya J, Marino A, Antela A, Navarro J, Esteban H, Moreno S; GeSIDA 7011 Study Group. Simplification to dual therapy (atazanavir/ritonavir + lamivudine) versus standard triple therapy [atazanavir/ritonavir + two nucleos(t)ides] in virologically stable patients on antiretroviral therapy: 96 week results from an open-label, non-inferiority, randomized clinical trial (SALT study). J Antimicrob Chemother. 2017 Jan;72(1):246-253. doi: 10.1093/jac/dkw379. Epub 2016 Sep 13.

ReferenceCitation: Di Giambenedetto S, Fabbiani M, Quiros Roldan E, Latini A, D'Ettorre G, Antinori A, Castagna A, Orofino G, Francisci D, Chinello P, Madeddu G, Grima P, Rusconi S, Di Pietro M, Mondi A, Ciccarelli N, Borghetti A, Foca E, Colafigli M, De Luca A, Cauda R; Atlas-M Study Group. Treatment simplification to atazanavir/ritonavir + lamivudine versus maintenance of atazanavir/ritonavir + two NRTIs in virologically suppressed HIV-1-infected patients: 48 week results from a randomized trial (ATLAS-M). J Antimicrob Chemother. 2017 Apr 1;72(4):1163-1171. doi: 10.1093/jac/dkw557.

ReferenceCitation: Pulido F, Ribera E, Lagarde M, Perez-Valero I, Palacios R, Iribarren JA, Payeras A, Domingo P, Sanz J, Cervero M, Curran A, Rodriguez-Gomez FJ, Tellez MJ, Ryan P, Barrufet P, Knobel H, Rivero A, Alejos B, Yllescas M, Arribas JR; DUAL-GESIDA-8014-RIS-EST45 Study Group. Dual Therapy With Darunavir and Ritonavir Plus Lamivudine vs Triple Therapy With Darunavir and Ritonavir Plus Tenofovir Disoproxil Fumarate and Emtricitabine or Abacavir and Lamivudine for Maintenance of Human Immunodeficiency Virus Type 1 Viral Suppression: Randomized, Open-Label, Noninferiority DUAL-GESIDA 8014-RIS-EST45 Trial. Clin Infect Dis. 2017 Nov 29;65(12):2112-2118. doi: 10.1093/cid/cix734.

ReferenceCitation: Llibre JM, Hung CC, Brinson C, Castelli F, Girard PM, Kahl LP, Blair EA, Angelis K, Wynne B, Vandermeulen K, Underwood M, Smith K, Gartland M, Aboud M. Efficacy, safety, and tolerability of dolutegravir-rilpivirine for the maintenance of virological suppression in adults with HIV-1: phase 3, randomised, non-inferiority SWORD-1 and SWORD-2 studies. Lancet. 2018 Mar 3;391(10123):839-849. doi: 10.1016/S0140-6736(17)33095-7. Epub 2018 Jan 6. Erratum In: Lancet. 2018 Feb 1;:

oa_host_type: closed

ReferenceCitation: Katlama C, Assoumou L, Valantin MA, Soulie C, Martinez E, Beniguel L, Bouchaud O, Raffi F, Molina JM, Fellahi S, Peytavin G, Marcelin AG, Kolta S, Capeau J, Gibowski S, Cardon F, Reynes J, Costagliola D; members of the ANRS 163 ETRAL study. Dual therapy combining raltegravir with etravirine maintains a high level of viral suppression over 96 weeks in long-term experienced HIV-infected individuals over 45 years on a PI-based regimen: results from the Phase II ANRS 163 ETRAL study. J Antimicrob Chemother. 2019 Sep 1;74(9):2742-2751. doi: 10.1093/jac/dkz224.

ReferenceCitation: Joly V, Burdet C, Landman R, Vigan M, Charpentier C, Katlama C, Cabie A, Benalycherif A, Peytavin G, Yeni P, Mentre F, Argoud AL, Amri I, Descamps D, Yazdanpanah Y; LAMIDOL Study Group. Dolutegravir and lamivudine maintenance therapy in HIV-1 virologically suppressed patients: results of the ANRS 167 trial (LAMIDOL). J Antimicrob Chemother. 2019 Mar 1;74(3):739-745. doi: 10.1093/jac/dky467.

ReferenceCitation: Taiwo BO, Marconi VC, Berzins B, Moser CB, Nyaku AN, Fichtenbaum CJ, Benson CA, Wilkin T, Koletar SL, Colasanti J, Acosta EP, Li JZ, Sax PE. Dolutegravir Plus Lamivudine Maintains Human Immunodeficiency Virus-1 Suppression Through Week 48 in a Pilot Randomized Trial. Clin Infect Dis. 2018 May 17;66(11):1794-1797. doi: 10.1093/cid/cix1131.

ReferenceCitation: van Wyk J, Ajana F, Bisshop F, De Wit S, Osiyemi O, Portilla Sogorb J, Routy JP, Wyen C, Ait-Khaled M, Nascimento MC, Pappa KA, Wang R, Wright J, Tenorio AR, Wynne B, Aboud M, Gartland MJ, Smith KY. Efficacy and Safety of Switching to Dolutegravir/Lamivudine Fixed-Dose 2-Drug Regimen vs Continuing a Tenofovir Alafenamide-Based 3- or 4-Drug Regimen for Maintenance of Virologic Suppression in Adults Living With Human Immunodeficiency Virus Type 1: Phase 3, Randomized, Noninferiority TANGO Study. Clin Infect Dis. 2020 Nov 5;71(8):1920-1929. doi: 10.1093/cid/ciz1243.

ReferenceCitation: Cahn P, Madero JS, Arribas JR, Antinori A, Ortiz R, Clarke AE, Hung CC, Rockstroh JK, Girard PM, Sievers J, Man C, Currie A, Underwood M, Tenorio AR, Pappa K, Wynne B, Fettiplace A, Gartland M, Aboud M, Smith K; GEMINI Study Team. Dolutegravir plus lamivudine versus dolutegravir plus tenofovir disoproxil fumarate and emtricitabine in antiretroviral-naive adults with HIV-1 infection (GEMINI-1 and GEMINI-2): week 48 results from two multicentre, double-blind, randomised, non-inferiority, phase 3 trials. Lancet. 2019 Jan 12;393(10167):143-155. doi: 10.1016/S0140-6736(18)32462-0. Epub 2018 Nov 9. Erratum In: Lancet. 2018 Nov 28;:

ReferenceCitation: Dybul M, Chun TW, Yoder C, Hidalgo B, Belson M, Hertogs K, Larder B, Dewar RL, Fox CH, Hallahan CW, Justement JS, Migueles SA, Metcalf JA, Davey RT, Daucher M, Pandya P, Baseler M, Ward DJ, Fauci AS. Short-cycle structured intermittent treatment of chronic HIV infection with highly active antiretroviral therapy: effects on virologic, immunologic, and toxicity parameters. Proc Natl Acad Sci U S A. 2001 Dec 18;98(26):15161-6. doi: 10.1073/pnas.261568398. Epub 2001 Dec 4.

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ReferenceCitation: Cohen CJ, Colson AE, Sheble-Hall AG, McLaughlin KA, Morse GD. Pilot study of a novel short-cycle antiretroviral treatment interruption strategy: 48-week results of the five-days-on, two-days-off (FOTO) study. HIV Clin Trials. 2007 Jan-Feb;8(1):19-23. doi: 10.1310/hct0801-19.

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ReferenceCitation: Reynolds SJ, Kityo C, Hallahan CW, Kabuye G, Atwiine D, Mbamanya F, Ssali F, Dewar R, Daucher M, Davey RT Jr, Mugyenyi P, Fauci AS, Quinn TC, Dybul MR. A randomized, controlled, trial of short cycle intermittent compared to continuous antiretroviral therapy for the treatment of HIV infection in Uganda. PLoS One. 2010 Apr 22;5(4):e10307. doi: 10.1371/journal.pone.0010307.

ReferenceCitation: Leibowitch J, Mathez D, de Truchis P, Ledu D, Melchior JC, Carcelain G, Izopet J, Perronne C, David JR. Four days a week or less on appropriate anti-HIV drug combinations provided long-term optimal maintenance in 94 patients: the ICCARRE project. FASEB J. 2015 Jun;29(6):2223-34. doi: 10.1096/fj.14-260315. Epub 2015 Apr 1.

ReferenceCitation: BREATHER (PENTA 16) Trial Group. Weekends-off efavirenz-based antiretroviral therapy in HIV-infected children, adolescents, and young adults (BREATHER): a randomised, open-label, non-inferiority, phase 2/3 trial. Lancet HIV. 2016 Sep;3(9):e421-e430. doi: 10.1016/S2352-3018(16)30054-6. Epub 2016 Jun 20.

ReferenceCitation: de Truchis P, Assoumou L, Landman R, Mathez D, Le Du D, Bellet J, Amat K, Katlama C, Gras G, Bouchaud O, Duracinsky M, Abe E, Alvarez JC, Izopet J, Saillard J, Melchior JC, Leibowitch J, Costagliola D, Girard PM, Perronne C; ANRS 162-4D Study Group. Four-days-a-week antiretroviral maintenance therapy in virologically controlled HIV-1-infected adults: the ANRS 162-4D trial. J Antimicrob Chemother. 2018 Mar 1;73(3):738-747. doi: 10.1093/jac/dkx434.

publisher_dissemination: Oxford University Press

ReferenceCitation: R. Landman, P. De Truchis, L. Assoumou, S. Lambert, K. Amat, J. Bellet, B. Lefebvre, C. Allavena, C. Katlama, Y. Yazdanpanah, J.-M. Molina, A. Gelley, S. Gibowski, J.-C. Alvarez, L. Morand-Joubert, D. Costagliola, P.-M. Girard, ANRS 170 QUATUOR study group -ANRS 170 QUATUOR 4/7 days maintenance strategy in antiretroviral treated adults with HIV-1 infection: an open randomised parallel non-inferiority phase III trial Abstract IAS2019 WEAB0406LB

ReferenceCitation: Parienti JJ, Das-Douglas M, Massari V, Guzman D, Deeks SG, Verdon R, Bangsberg DR. Not all missed doses are the same: sustained NNRTI treatment interruptions predict HIV rebound at low-to-moderate adherence levels. PLoS One. 2008 Jul 30;3(7):e2783. doi: 10.1371/journal.pone.0002783.

ReferenceCitation: Pogany K, van Valkengoed IG, Prins JM, Nieuwkerk PT, van der Ende I, Kauffmann RH, Kroon FP, Verbon A, Nievaard MF, Lange JM, Brinkman K. Effects of active treatment discontinuation in patients with a CD4+ T-cell nadir greater than 350 cells/mm3: 48-week Treatment Interruption in Early Starters Netherlands Study (TRIESTAN). J Acquir Immune Defic Syndr. 2007 Apr 1;44(4):395-400. doi: 10.1097/QAI.0b013e31802f83bc. Erratum In: J Acquir Immune Defic Syndr. 2007 Apr 15;44(5):607. Vanvalkengoed, Irene G [corrected to van Valkengoed, Irene G M].

ReferenceCitation: Zehnacker L, Abe E, Mathez D, Alvarez JC, Leibowitch J, Azoulay S. Plasma and Intracellular Antiretroviral Concentrations in HIV-Infected Patients under Short Cycles of Antiretroviral Therapy. AIDS Res Treat. 2014;2014:724958. doi: 10.1155/2014/724958. Epub 2014 Nov 9.

location_facility: Hôpital Tenon/Service des Maladies Infectieuses

location_facility: Hôpital Antoine Béclère/Service d'Immunologie Clinique et Médecine Interne

location_facility: Hôpital Pellegrin/Service des Maladies Infectieuses et Tropicales

location_facility: Centre Hospitalier Sud-Francilien/Service d'Hématologie

location_facility: Hôpital Foch/Service de Médecine Interne

location_facility: Hôpital Delafontaine/Service des Maladies Infectieuses

location_facility: Hôpital Côte de Nacre/Service des Maladies Infectieuses

location_facility: Centre Hospitalier René Dubos/Service de Dermatologie

location_facility: Hôpital Saint Antoine/Service des Maladies Infectieuses

location_facility: Hôpital Pierre Zobda-Quitman/Service de Médecine Interne

location_facility: Hôpital Bichat/Service des Maladies Infectieuses

location_facility: Hôpital Européen/Consultation de Médecine Interne et Maladies Infectieuses

location_facility: Hôpital de l'Hôtel Dieu/Service des Maladies Infectieuses

location_facility: Hôpital Pitié-Salpêtrière/Service des Maladies Infectieuses

location_facility: Hôpital Hôtel Dieu/Service d'Immunologie Clinique

location_facility: Centre hospitalier Victor Dupouy/Service d'Hématologie-Unité d'Immunologie

location_facility: Hôpital Gui de Chauliac/Service des Maladies Infectieuses

location_facility: Hôpital Raymond Poincaré/Service des Maladies Infectieuses

location_facility: CHU Dupuytren 1/Service des Maladies Infectieuses et Tropicales

location_facility: Hôpital Bretonneau/Service des Maladies Infectieuses

location_facility: Hôpital Robert DEBRE/Service des maladies infectieuses

location_facility: Centre hospitalier de Poissy/Service des Maladies Infectieuses

location_facility: Hôpital Purpan/Service des Maladies Infectieuses

location_facility: Hôpital de l'Archet/Service des Maladies Infectieuses

location_facility: Hôpital Sainte Marguerite/Service d'Immuno-Hématologie Clinique

location_facility: CHD de La Roche sur Yon/Service de Médecine Interne

location_facility: Hôpital Saint Louis/Service des Maladies Infectieuses

location_facility: Hôpital Civil/Service Le Trait D'union UF 2066

location_facility: Hôpital Lariboisière/Service de Médecine Interne

location_facility: Hôpital Gustave Dron/Service des Maladies Infectieuses

location_facility: Hôpital Saint André/Service HDJ Maladies Infectieuses

location_facility: Hôpital Hôtel Dieu/Unité fonctionnelle de Pathologie Infectieuse

location_facility: Hôpital Avicenne/Service des Maladies Infectieuses et tropicales

location_facility: Hôpital Louis Pasteur/Service des Maladies Infectieuses

location_facility: Hôpital François Mitterrand/Service des Maladies Infectieuses

location_facility: Hôpital de la Croix Rousse/Service des Maladies Infectieuses

location_facility: Hôpital Necker/Service des Maladies Infectieuses

title: Randomized, Open-label and Multicentric Trial Evaluating the Non-inferiority of Antiretroviral Dual Therapy Taken 4 Consecutive Days Per Week Versus Antiretroviral Dual Therapy 7/7 Days Per Week in HIV-1 Infected Patients With Controlled Viral Load Under Antiretroviral Dual Therapy

location_country: Martinique France


title: Outcome After Pancreatectomy for Neuroendocrine Tumor and Evaluation of the WHO 2017 Grading System: a Retrospective Multicentric Analysis of 138 Consecutive Patients.

acronym: PanTEN

summary:
Aim: The aim of this study was to investigate the clinicopathological factors and to evaluate the prognostic accuracy of the new World Health Organization (WHO) 2017 grading system in pancreatic neuroendocrine tumor (PanNET) patients.

Methods: Data collected between 1997 and December 2017 were analyzed. Histological grading and staging was based on the WHO 2017 grading system. Outcome after surgery and predictors of overall survival (OS) and disease free survival (DFS) were evaluated.

lead_sponsor: University Hospital, Montpellier

collaborators: Department of digestive surgery, Carémeau Hospital, 30900, Nîmes, France

collaborators: Department of oncology, Carémeau Hospital, 30900, Nîmes, France

collaborators: Oncology - Institut du Cancer de Montpellier (ICM), Montpellier, France

collaborators: Digestive & Oncologic Surgery - Institut du Cancer de Montpellier (ICM), Montpellier, France


title: The Benefit of Using the Lactobacillus Reuteri Probiotic as a Supplement in the Treatment of Newborn Colic

acronym: PROBIOC

summary: The purpose of this study is to evaluate the efficacy of the oral administration of Lactobacillus reuteri in treating infantile colic as defined by the Rome III criteria. Forty breastfed infants aged from 29 days to 3 months will be enrolled and blinded randomized to receive orally L.reuteri or placebo. The rate of responders (reduction of daily crying time >50% compared to the baseline) will be assessed at day 7, day 14 and day 21 in both groups. The average daily crying time as well as the associated digestive symptoms will also be analyzed.

status: Withdrawn

lead_sponsor: BioGaia AB

collaborators: Association Clinique Thérapeutique Infantile du val de Marne


title: Quality of Life Assessment of Women Undergoing Laparoscopic Removal of Essure System : a Before-and-after Study

acronym: ESSURE

summary: To evaluate quality of life before and after laparoscopic removal of the Essure® system. Women who complain about symptoms attributed to the Essure® device are expected to have an improved quality of life postoperatively.

collaborators: La Conception Hospital - Marseille - France

location_facility:
Montpellier University Hospital
Public Assistance - Marseille Hospitals


lead_sponsor: Genfit

summary: The purpose of this study is to evaluate the efficacy of GFT505 80mg compared with placebo in improving Oral Glucose Tolerance Test (OGTT), in patients with impaired glucose tolerance and abdominal obesity, and to assess the tolerability and safety of once-a-day administrations of oral doses of GFT505 during 35 days.

ReferenceCitation: Staels B, Rubenstrunk A, Noel B, Rigou G, Delataille P, Millatt LJ, Baron M, Lucas A, Tailleux A, Hum DW, Ratziu V, Cariou B, Hanf R. Hepatoprotective effects of the dual peroxisome proliferator-activated receptor alpha/delta agonist, GFT505, in rodent models of nonalcoholic fatty liver disease/nonalcoholic steatohepatitis. Hepatology. 2013 Dec;58(6):1941-52. doi: 10.1002/hep.26461. Epub 2013 Oct 29.

publisher_dissemination: Wolters Kluwer Health

ReferenceCitation: Cariou B, Zair Y, Staels B, Bruckert E. Effects of the new dual PPAR alpha/delta agonist GFT505 on lipid and glucose homeostasis in abdominally obese patients with combined dyslipidemia or impaired glucose metabolism. Diabetes Care. 2011 Sep;34(9):2008-14. doi: 10.2337/dc11-0093. Epub 2011 Aug 4.

location_facility:
Site n°31
Site n°37
Site n°1
Site n°11
Site n°18
Site n°10
Site n°35
Site n°2
Site n°19
Site n°14
Site n°15
Site n°16
Site n°34
Site n°12
Site n°39
Site n°36
Site n°13
Site n°32
Site n°17
Site n°30

title: A Pilot Study to Evaluate the Efficacy and Safety of GFT505 (80 mg) Orally Administered Once Daily for 35 Days in Patients Presenting With Impaired Glucose Tolerance and Abdominal Obesity. A Double Blind, Parallel Group, Placebo-controlled and Randomized Study.


summary: The purpose of this study is to evaluate the efficacy of GFT505 80mg in reducing serum Triglycerides (TG) and increasing High Density Lipoprotein Cholesterol (HDL-C) levels compared with placebo in atherogenic dyslipidaemic patients with abdominal obesity, and to assess the tolerability and safety of once-a-day administrations of oral doses of GFT505 during 28 days.

location_facility:
Site n°52
Site n°64
Site n°31
Site n°62
Site n°41
Site n°33
Site n°37
Site n°53
Site n°1
Site n°63
Site n°78
Site n°80
Site n°82
Site n°18
Site n°11
Site n°20
Site n°60
Site n°91
Site n°23
Site n°10
Site n°35
Site n°19
Site n°14
Site n°77
Site n°55
Site n°17
Site n°16
Site n°50
Site n°79
Site n°34
Site n°42
Site n°75
Site n°74
Site n°21
Site n°12
Site n°39
Site n°45
Site n°61
Site n°36
Site n°40
Site n°13
Site n°38
Site n°51
Site n°65
Site n°32
Site n°26
Site n°30

title: A Pilot Study to Evaluate the Efficacy and Safety of GFT505 (80mg) Orally Administered Once Daily for 28 Days in Atherogenic Dyslipidaemic Patients With Abdominal Obesity. A Double Blind, Placebo-controlled and Randomized Study.

location_country: Romania Tunisia France


title: An Observational Study to Collect Data Characterizing Analgesia in Patients Suffering From Bone Metastasis Induced Pain

summary: Up to 180 patients with bone metastasis and requiring analgesic treatment will be followed during 4 to 10 weeks. All patients will continue to receive their cancer therapeutic treatments and be treated for pain relief exactly as they would normally be by the Investigator based on their needs. During their regular visits to the Investigator, patients will complete questionnaires and Clinical Pain Assessments.

location_facility:
Centre Oscar Lambert
Cliniques Universitaires Saint Luc
Universitair Ziekenhuis Antwerpen
Institut Curie
Hôpital La Timone
Hôpital A. Mignot
Institut Bordet
ATC, CHU Sart Tilman


title: Covid-19 Effects on ARTErial StIffness and Vascular AgiNg

acronym: CARTESIAN

summary: The purpose of the study is to evaluate the presence of early vascular aging 6 months and 12 months after COVID-19 infection.

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

lead_sponsor: Assistance Publique - Hôpitaux de Paris

collaborators: The Association for Research into Arterial Structure and Physiology

location_facility: Hôpital Européen Georges Pompidou - APHP


title: VIH-1 Colo-rectal Transmission by Infected Semen Cells and Effects of Seminal Plasma ex Vivo

acronym: CellspermVIH

summary: The objective of our project is to determine the infected seminal cell types and the molecular mechanisms involved in HIV cell-associated transmission in the colo-rectal mucosa, using conditions as close as possible to real life, i.e. seminal leukocytes and seminal plasma from HIV-infected donors and tissue explants

ReferenceCitation: Roulet V, Satie AP, Ruffault A, Le Tortorec A, Denis H, Guist'hau O, Patard JJ, Rioux-Leclerq N, Gicquel J, Jegou B, Dejucq-Rainsford N. Susceptibility of human testis to human immunodeficiency virus-1 infection in situ and in vitro. Am J Pathol. 2006 Dec;169(6):2094-103. doi: 10.2353/ajpath.2006.060191.

ReferenceCitation: Le Tortorec A, Le Grand R, Denis H, Satie AP, Mannioui K, Roques P, Maillard A, Daniels S, Jegou B, Dejucq-Rainsford N. Infection of semen-producing organs by SIV during the acute and chronic stages of the disease. PLoS One. 2008 Mar 12;3(3):e1792. doi: 10.1371/journal.pone.0001792.

ReferenceCitation: Le Tortorec A, Satie AP, Denis H, Rioux-Leclercq N, Havard L, Ruffault A, Jegou B, Dejucq-Rainsford N. Human prostate supports more efficient replication of HIV-1 R5 than X4 strains ex vivo. Retrovirology. 2008 Dec 31;5:119. doi: 10.1186/1742-4690-5-119.

ReferenceCitation: Houzet L, Matusali G, Dejucq-Rainsford N. Origins of HIV-infected leukocytes and virions in semen. J Infect Dis. 2014 Dec 15;210 Suppl 3:S622-30. doi: 10.1093/infdis/jiu328.

ReferenceCitation: Camus C, Matusali G, Bourry O, Mahe D, Aubry F, Bujan L, Pasquier C, Massip P, Ravel C, Zirafi O, Munch J, Roan NR, Pineau C, Dejucq-Rainsford N. Comparison of the effect of semen from HIV-infected and uninfected men on CD4+ T-cell infection. AIDS. 2016 May 15;30(8):1197-208. doi: 10.1097/QAD.0000000000001048.

ReferenceCitation: Anderson DJ, Politch JA, Nadolski AM, Blaskewicz CD, Pudney J, Mayer KH. Targeting Trojan Horse leukocytes for HIV prevention. AIDS. 2010 Jan 16;24(2):163-87. doi: 10.1097/QAD.0b013e32833424c8. No abstract available.

ipd_sharing_description:
The duplicated part of the CRFs will then be sent to Mrs DEJUC at the IRST in Rennes, the remaining part will be kept in the investigating center.

All the data of the study transcribed by the investigator in the CRFs will be transmitted electronically to the person in charge of the data of the INSERM / IRSET 1085 unit. Upon receipt, the data will be entered simply by typing and re-reading on the Excel spreadsheet. The files will be locked by password and backed up daily with storage for 3 months on the server of the INSERM 1085 unit managed by the IT department of the University of Rennes 1. The set Data is saved every evening, with storage for 4 weeks, then archived monthly on tape.

location_facility:
CECOS Hôpital Paule de Viguier
CECOS Bretagne Rennes
CECOS Paris Bichat