title: A Phase I Dose-Escalation/Dose Expansion Study Of NBTXR3 Activated By Intensity Modulated Radiation Therapy In Patients With Locally Advanced Squamous Cell Carcinoma Of The Oral Cavity Or Oropharynx

summary: RATIONALE: Cancers of the oral cavity represent 30% of head and neck carcinomas in the western world. The oropharynx is the posterior continuation of the oral cavity and connects with the nasopharynx (above) and laryngopharynx (below). It is also a frequent site of primary head and neck cancers. These structures play a crucial role in swallowing, breath and speech. Locally advanced oropharyngeal cancers can obstruct the air flow or infiltrate muscles or nerves, which significantly disturb local functions. The incidence of Head and Neck Squamous Cell Cancer in patients older 65 years is high, 47% occurred in this population as recorded by the Surveillance, Epidemiology, and End Results registries in the United States. Regarding the therapeutic strategies, the association of radiotherapy with chemotherapy or biologics has demonstrated significant improvement of outcomes with the drawback of higher toxicity, or as demonstrated by 2 meta-analyses, without survival improvement in older patients. NBTXR3 and radiation therapy may increase the cancer cell killing and complete tumor shrinkage allowing a definitive treatment and preservation of local structures and functions in patients older 65 years, who cannot receive cisplatin.

ReferenceCitation: Hoffmann C, Calugaru V, Borcoman E, Moreno V, Calvo E, Liem X, Salas S, Doger B, Jouffroy T, Mirabel X, Rodriguez J, Chilles A, Bernois K, Dimitriu M, Fakhry N, Hee Kam SW, Le Tourneau C. Phase I dose-escalation study of NBTXR3 activated by intensity-modulated radiation therapy in elderly patients with locally advanced squamous cell carcinoma of the oral cavity or oropharynx. Eur J Cancer. 2021 Mar;146:135-144. doi: 10.1016/j.ejca.2021.01.007. Epub 2021 Feb 16.

family: Hoffmann

full_name: Caroline Hoffmann

given: Caroline

family: Calugaru

full_name: Valentin Calugaru

given: Valentin

family: Borcoman

full_name: Edith Borcoman

given: Edith

family: Moreno

full_name: Victor Moreno

given: Victor

family: Calvo

full_name: Emiliano Calvo

given: Emiliano

family: Liem

full_name: Xavier Liem

family: Salas

full_name: Sébastien Salas

given: Sébastien

family: Doger

full_name: Bernard Doger

given: Bernard

family: Jouffroy

full_name: Thomas Jouffroy

given: Thomas

family: Mirabel

full_name: Xavier Mirabel

family: Rodriguez

full_name: Jose Rodriguez

given: Jose

family: Chilles

full_name: Anne Chilles

given: Anne

family: Bernois

full_name: Katell Bernois

given: Katell

family: Dimitriu

full_name: Mikaela Dimitriu

given: Mikaela

family: Fakhry

full_name: Nicolas Fakhry

given: Nicolas

family: Hee Kam

full_name: Stéphanie Wong Hee Kam

given: Stéphanie Wong

family: Le Tourneau

full_name: Christophe Le Tourneau

given: Christophe

journal_name: European Journal of Cancer

lead_sponsor: Nanobiotix

location_country: Spain Hungary France Poland

location_facility: Institut de Cancérologie de la Loire Lucien Neuwirth

location_facility: Świętokrzyskie Centrum Onkologii Samodzielny Publiczny Zakład Opieki Zdrowotnej W Kielcach

location_facility: Nu-Med Centrum Diagnostyki I Terapii Onkologicznej Zamość Spółka Z Ograniczoną Odpowiedzialnością

location_facility: Hospital Universitario Madrid Sanchinarro

location_facility: Hospital Universitario Regional de Malaga

location_facility: Centrum Onkologii - Instytut im. M. Skłodowskiej- Curie, Oddział w Gliwicach

location_facility: Centrum Onkologii Ziemi Lubelskiej im. Św. Jana z Dukli


type: Other Identifier

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.

status: Unknown status

study_completion_date_type: Anticipated

study_type: Interventional

design_allocation: Randomized

primary_purpose: Other

enrollment_type: Anticipated

ReferenceType: derived

ReferenceCitation: Soubeyran P, Terret C, Bellera C, Bonnetain F, Jean OS, Galvin A, Chakiba C, Zwolakowski MD, Mathoulin-Pélissier 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.

ipd_sharing: Undecided

lead_sponsor: Institut Bergonié

location_facility: Centre Hospitalier Universitaire de Poitiers

location_facility: Centre Hospitalier Métropôle Savoie Chambéry

location_facility: Centre Hospitalier Universitaire de Strasbourg

location_facility: Centre Hospitalier Universitaire de Martinique

location_facility: Centre Hospitalier Universitaire de Lille

location_facility: Centre Hospitalier Intercommunal de Castres Mazamet

location_facility: Centre Hospitalier Universitaire de Tours

location_facility: Centre Hospitalier Universitaire de Clermont-Ferrand

location_facility: Centre Hospitalier Intercommunal de Cornouaille

location_facility: Centre Hospitalier Privé de Saint Grégoire

location_facility: Institut Bergonié Centre Régional de Lutte Contre le Cancer

location_facility: Centre Hospitalier Universitaire de Nantes

location_facility: Centre Hospitalier Universitaire de Rennes

location_facility: Centre Hospitalier Intercommunal de Créteil

location_facility: Centre Hospitalier Universitaire de Rouen

location_facility: Centre Hospitalier Universitaire de Nîmes

location_facility: Centre Hospitalier Universitaire de Caen

location_facility: Centre Hospitalier Universitaire de Grenoble

intervention_type: Other

lead_sponsor_type: industriel

status_simplified: Unknown


title: Targeting Glutamine Metabolism to Prevent Diabetic Cardiovascular Complications

acronym: GLUTADIAB

summary: Experimental data suggest that glutamine catabolism in involved in the activation of macrophages by generating TCA(Tricarboxylic acid) intermediates that promote the pro-inflammatory polarization of macrophages. The project investigates the possible link between glutaminolysis, monocytes polarization and diabetes related cardiovascular complications in humans

study_start_date_type: Actual

status: Recruiting

study_type: Observational

time_perspective: Cross-Sectional

lead_sponsor: Assistance Publique - Hôpitaux de Paris

location_facility:
Diabétologie - Hôpital Lariboisière
Cardiologie Lariboisière
Diabetologie Lariboisière
Cardiologie Bichat

intervention_type: Biological

lead_sponsor_type: academique

status_simplified: Ongoing


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

study_completion_date_type: Actual

primary_purpose: Treatment

enrollment_type: Actual

lead_sponsor: LivaNova

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

intervention_type: Device

status_simplified: Completed


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.

ipd_sharing: No

lead_sponsor: Centre Oscar Lambret

location_facility:
Centre Oscar LAMBRET
Centre Léon Bérard
Centre François Baclesse
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. 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

location_country: Belgium France

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


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, Latrémouille C, Rémy A, Provenchère S, Carillion A, Achouh P, Labrousse L, Tran Dinh A, Ait Hamou N, Charfeddine A, Lafourcade A, Hajage D, Bouglé 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.

family: Amour

full_name: Julien Amour

given: Julien

sequence: first

family: Cholley

full_name: Bernard Cholley

sequence: additional

family: Ouattara

full_name: Alexandre Ouattara

given: Alexandre

family: Longrois

full_name: Dan Longrois

given: Dan

family: Leprince

full_name: Pascal Leprince

given: Pascal

family: Fellahi

full_name: Jean-Luc Fellahi

given: Jean-Luc

family: Riou

full_name: Bruno Riou

given: Bruno

family: Hariri

full_name: Sarah Hariri

given: Sarah

family: Latrémouille

full_name: Christian Latrémouille

given: Christian

family: Rémy

full_name: Alain Rémy

given: Alain

family: Provenchère

full_name: Sophie Provenchère

given: Sophie

family: Carillion

full_name: Aude Carillion

given: Aude

family: Achouh

full_name: Paul Achouh

given: Paul

family: Labrousse

full_name: Louis Labrousse

given: Louis

family: Tran Dinh

full_name: Alexy Tran Dinh

given: Alexy

family: Ait Hamou

full_name: Nora Ait Hamou

given: Nora

family: Charfeddine

full_name: Ahmed Charfeddine

given: Ahmed

family: Lafourcade

full_name: Alexandre Lafourcade

family: Hajage

full_name: David Hajage

given: David

family: Bouglé

full_name: Adrien Bouglé

given: Adrien

family: Puybasset

full_name: Louis Puybasset

family: Margetis

full_name: Dimitri Margetis

given: Dimitri

family: Lebreton

full_name: Guillaume Lebreton

given: Guillaume


title: Spartalizumab, mDCF (Docetaxel, Cisplatin and 5-fluorouracil) and Radiotherapy in Patients With Metastatic Squamous Cell Anal Carcinoma. A Phase IIA Study

acronym: SPARTANA

summary: This study evaluates the feasibility of the combination of radiotherapy, chemotherapies (docetaxel, cisplatin and 5-fluorouracil) and spartalizumab (anti-PD-1 therapy) in patients with metastatic squamous cell anal carcinoma

study_start_date_type: Anticipated

status: Not yet recruiting

ReferenceType: background

ReferenceCitation: Kim S, François E, André T, Samalin E, Jary M, El Hajbi F, Baba-Hamed N, Pernot S, Kaminsky MC, Bouché O, Desrame J, Zoubir M, Ghiringhelli F, Parzy A, De La Fouchardiere C, Smith D, Deberne M, Spehner L, Badet N, Adotevi O, Anota A, Meurisse A, Vernerey D, Taieb J, Vendrely V, Buecher B, Borg C. Docetaxel, cisplatin, and fluorouracil chemotherapy for metastatic or unresectable locally recurrent anal squamous cell carcinoma (Epitopes-HPV02): a multicentre, single-arm, phase 2 study. Lancet Oncol. 2018 Aug;19(8):1094-1106. doi: 10.1016/S1470-2045(18)30321-8. Epub 2018 Jul 2.

family: Kim

full_name: Stefano Kim

given: Stefano

family: François

full_name: Eric François

given: Eric

family: André

full_name: Thierry André

given: Thierry

family: Samalin

full_name: Emmanuelle Samalin

given: Emmanuelle

family: Jary

full_name: Marine Jary

given: Marine

family: El Hajbi

full_name: Farid El Hajbi

given: Farid

family: Baba-Hamed

full_name: Nabil Baba-Hamed

given: Nabil

family: Pernot

full_name: Simon Pernot

given: Simon

family: Kaminsky

full_name: Marie-Christine Kaminsky

given: Marie-Christine

family: Bouché

full_name: Olivier Bouché

given: Olivier

family: Desrame

full_name: Jérôme Desrame

given: Jérôme

family: Zoubir

full_name: Mustapha Zoubir

given: Mustapha

family: Ghiringhelli

full_name: François Ghiringhelli

given: François

family: Parzy

full_name: Aurélie Parzy

given: Aurélie

family: De La Fouchardiere

full_name: Christelle De La Fouchardiere

given: Christelle

family: Smith

full_name: Denis Smith

given: Denis

family: Deberne

full_name: Mélanie Deberne

given: Mélanie

family: Spehner

full_name: Laurie Spehner

given: Laurie

family: Badet

full_name: Nicolas Badet

given: Nicolas

family: Adotevi

full_name: Olivier Adotevi

family: Anota

full_name: Amélie Anota

given: Amélie

family: Meurisse

full_name: Aurélia Meurisse

given: Aurélia

family: Vernerey

full_name: Dewi Vernerey

given: Dewi

ReferenceCitation: Kim S, Meurisse A, Spehner L, Stouvenot M, François E, Buecher B, André T, Samalin E, Jary M, Nguyen T, El Hajbi F, Baba-Hamed N, Pernot S, Kaminsky MC, Bouché O, Desrame J, Zoubir M, Ghiringhelli F, Parzy A, de la Fouchardiere C, Boulbair F, Lakkis Z, Klajer E, Jacquin M, Taieb J, Vendrely V, Vernerey D, Borg C. Pooled analysis of 115 patients from updated data of Epitopes-HPV01 and Epitopes-HPV02 studies in first-line advanced anal squamous cell carcinoma. Ther Adv Med Oncol. 2020 Dec 4;12:1758835920975356. doi: 10.1177/1758835920975356. eCollection 2020.

ReferenceCitation: Kim S, Buecher B, André T, Jary M, Bidard FC, Ghiringhelli F, François É, Taieb J, Smith D, de la Fouchardière C, Desramé J, Samalin E, Parzy A, Baba-Hamed N, Bouché O, Tougeron D, Dahan L, El Hajbi F, Jacquin M, Rebucci-Peixoto M, Spehner L, Vendrely V, Vernerey D, Borg C. Atezolizumab plus modified docetaxel-cisplatin-5-fluorouracil (mDCF) regimen versus mDCF in patients with metastatic or unresectable locally advanced recurrent anal squamous cell carcinoma: a randomized, non-comparative phase II SCARCE GERCOR trial. BMC Cancer. 2020 Apr 25;20(1):352. doi: 10.1186/s12885-020-06841-1.

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - UFC - Université de Franche-Comté

lead_sponsor: Centre Hospitalier Universitaire de Besancon

location_facility: Centre Hospitalier Universitaire de Besançon


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.

location_facility:
Hôpital des Enfants
Centre Léon Bérard
Centre Oscar Lambret


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

intervention_type: Procedure


ReferenceCitation: Lupi O. Correlations between the Sonic Hedgehog pathway and basal cell carcinoma. Int J Dermatol. 2007 Nov;46(11):1113-7. Review.

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.

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. Review. 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.

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

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.

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.

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. Review.

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.

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.

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.

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.

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.

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.

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.

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.

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. Epub 2006 Mar 25. Review.

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.

ReferenceCitation: Ingham PW, McMahon AP. Hedgehog signaling in animal development: paradigms and principles. Genes Dev. 2001 Dec 1;15(23):3059-87. Review.

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

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. Epub 2005 Nov 14. Review.

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. Review.

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

ReferenceCitation: Pasca di Magliano M, Hebrok M. Hedgehog signalling in cancer formation and maintenance. Nat Rev Cancer. 2003 Dec;3(12):903-11. Review.

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.

intervention_type: Drug

status: Terminated

lead_sponsor: Centre Leon Berard

location_country:
Italy
United Kingdom
France
Switzerland

acronym:
MEVITEM

 MEVITEM

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

location_facility: Institut Claudius Régaud (iuct-oncopole)

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

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

location_facility: Centre Hospitalier Universitaire Vaudois (CHUV)

type: EudraCT Number

source: euctr

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

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.


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. Erratum in: Bone Res. 2020 Sep 21;8(1):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. 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. Epub 2016 Sep 16. Review.

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. Review.

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. Review.

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.

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

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

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

time_perspective: Prospective

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.

family: Vannimenus

full_name: Corinne Vannimenus

given: Corinne

family: Bricout

full_name: Hélène Bricout

given: Hélène

family: Le Rouzic

full_name: Olivier Le Rouzic

family: Mouawad

full_name: François Mouawad

family: Chevalier

full_name: Dominique Chevalier

given: Dominique

family: Dansin

full_name: Eric Dansin

given: Eric

family: Rotsaert

full_name: Laurence Rotsaert

given: Laurence

family: Lefebvre

full_name: Gautier Lefebvre

given: Gautier

family: Cottencin

full_name: Olivier Cottencin

family: Porte

full_name: Henri Porte

given: Henri

family: Scherpereel

full_name: Arnaud Scherpereel

given: Arnaud

family: El Fahsi

full_name: Asmaa El Fahsi

given: Asmaa

family: Richard

full_name: Florence Richard

given: Florence

family: Rolland

full_name: Benjamin Rolland

given: Benjamin

bso_classification: Medical research

currency_apc_doaj: GBP

datasource: user

genre: journal-article

genre_raw: journal-article

journal_name: BMC Cancer

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 - memSIC

repository_normalized: HAL

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

evidence: oa repository (via pmcid lookup)

license_normalized: no license

location_facility: Centre Hospitalier Régional et Universitaire - Hopital HURIEZ

location_facility: Centre Hospitalier Régional et Universitaire - Hopital CALMETTE


title: A Double-blind, Randomized, Placebo-controlled, Combined Single and Multiple Ascending Dose Study to Investigate the Safety, Tolerability and Pharmacokinetic Profile of IFB-088, in Healthy Volunteers

summary: This is the first study of single and multiple doses of IFB-088 in human subjects. The current study is designed to assess in the first part, the safety, tolerability, plasma and urine pharmacokinetics (PK) of single oral doses of IFB-088 in healthy subjects (Single Ascending Doses - SAD) and in a second part safety, tolerability, plasma and urine pharmacokinetics (PK) of multiple oral doses of IFB-088 in healthy subjects (Multiple Ascending Doses - MAD)

lead_sponsor: InFlectis BioScience

location_facility: Centre d'Investigation Clinique - Centre de Pharmacologie Clinique et d'Evaluations Thérapeutiques (CIC-CPCET)


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.

design_allocation: Non-Randomized

primary_purpose: Basic Science

lead_sponsor: Nantes University Hospital


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, André M, Arnaud C, Pierrat V, Rozé JC, Messer J, Thiriez G, Burguet A, Picaud JC, Bréart 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.

location_facility: Service de radiopédiatrie - Hôpital Robert Debré

location_facility: Service de radiopédiatrie. Hôpital Necker

location_facility: Service de Radiopédiatrie. Hôpital Trousseau


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.

lead_sponsor: CHU de Reims

location_facility:
Chu Reims
Centre Hospitalier
Chu Strasbourg
HEGP
CHU


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.

family: Braillon

full_name: Alain Braillon

given: Alain

family: Naudet

full_name: Florian Naudet

given: Florian

journal_name: Mayo Clinic Proceedings

oa_host_type: publisher

evidence: open (via free pdf)

publisher: Elsevier BV

publisher_dissemination: Elsevier

publisher_group: Elsevier

publisher_normalized: Elsevier

lead_sponsor: Ethypharm

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


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

location_facility:
Clinical Investigation Center
Pneumology
Pediatric
Nephrology


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.

time_perspective: Retrospective

ipd_sharing_description: NC


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


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 Myélodysplasies. 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.

name: Assistance Publique-Hôpitaux de Paris, Service d’Hématologie Biologique, Hôpitaux Universitaires Paris Centre, Paris, France;

name: Institut Cochin, INSERM U1016, Centre National de la Recherche Scientifique, Unité Mixte de Recherche 8104, Université Paris Descartes, Paris, France;

family: Chesnais

full_name: Virginie Chesnais

given: Virginie

name: Laboratoire d’Hématologie, Centre Hospitalier Régional Universitaire de Lille, Lille, France;

family: Renneville

full_name: Aline Renneville

given: Aline

name: Assistance Publique–Hôpitaux de Paris, Service d’Hématologie Clinique, Hôpital Henri-Mondor, Créteil, France;

family: Toma

full_name: Andrea Toma

given: Andrea

name: Service de Biostatistique et d’Information Médicale, Hôpital Saint-Louis, Assistance Publique–Hôpitaux de Paris, Paris, France;

name: Epidémiologie Clinique et Statistiques pour la Recherche en Santé, Unité Mixte de Recherche 1153, INSERM, Université Paris Diderot, Sorbonne Paris Cité, France;

family: Lambert

full_name: Jérôme Lambert

given: Jérôme

family: Passet

full_name: Marie Passet

given: Marie

family: Dumont

full_name: Florent Dumont

given: Florent

family: Chevret

full_name: Sylvie Chevret

given: Sylvie

family: Lejeune

full_name: Julie Lejeune

given: Julie

family: Raimbault

full_name: Anna Raimbault

given: Anna

name: Centre de Lutte contre le Cancer Henri-Becquerel, Rouen, France;

family: Stamatoullas

full_name: Aspasia Stamatoullas

given: Aspasia

name: Service d’Hématologie, Hôpital Saint Vincent de Paul, Université Catholique de Lille, Lille, France;

family: Rose

full_name: Christian Rose

given: Christian

name: Service de Médecine Interne, Institut Universitaire du Cancer, Toulouse, France;

family: Beyne-Rauzy

full_name: Odile Beyne-Rauzy

given: Odile

name: Service d’Hématologie, Centre Hospitalier Universitaire, Nantes, France;

family: Delaunay

full_name: Jacques Delaunay

given: Jacques

name: Institut Gustave Roussy, INSERM 1009, Université Paris Sud, Villejuif, France; and

family: Solary

full_name: Eric Solary

name: Assistance Publique–Hôpitaux de Paris, Service d’Hématologie Senior, Hôpital Saint-Louis, Paris, France

family: Fenaux

full_name: Pierre Fenaux

given: Pierre

family: Dreyfus

full_name: François Dreyfus

given: François

family: Preudhomme

full_name: Claude Preudhomme

given: Claude

family: Kosmider

full_name: Olivier Kosmider

given: Olivier

family: Fontenay

full_name: Michaela Fontenay

given: Michaela

journal_name: Blood

oa_host_type: repository

location_facility: Hematology Dpt, Hôpital la pitié-Salpétrière

location_facility: Hematology Dpt, Service d'Hématologie Clinique

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

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

location_facility: Hematology Dpt, Centre Hospitalier Lyon Sud


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.

family: Charrier

full_name: Nathanael Charrier

given: Nathanael

name: the ARS Ile de France telemedicine group

family: Zarca

full_name: Kevin Zarca

given: Kevin

family: Durand-Zaleski

full_name: Isabelle Durand-Zaleski

given: Isabelle

family: Calinaud

full_name: Christine Calinaud

given: Christine

journal_name: BMC Health Services Research

publisher: Springer Science and Business Media LLC

publisher_dissemination: Springer-Nature

publisher_group: Springer-Nature

publisher_normalized: Springer

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


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.

primary_purpose: Diagnostic

location_country: Germany France Switzerland Spain

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


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


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.

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


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

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

location_facility: Immunopathologie Clinique - Hôpital Saint Louis - AP HP

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


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.

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

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

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. Review.

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.

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.

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.

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.

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.

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.

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, Péran 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.

family: Yrondi

full_name: Antoine Yrondi

given: Antoine

family: Aouizerate

full_name: Bruno Aouizerate

given: Bruno

family: El-Hage

full_name: Wissam El-Hage

given: Wissam

family: Moliere

full_name: Fanny Moliere

given: Fanny

family: Thalamas

full_name: Claire Thalamas

given: Claire

family: Delcourt

full_name: Nicolas Delcourt

given: Nicolas

family: Sporer

full_name: Marie Sporer

given: Marie

family: Taib

full_name: Simon Taib

given: Simon

family: Schmitt

full_name: Laurent Schmitt

given: Laurent

family: Arlicot

full_name: Nicolas Arlicot

family: Meligne

full_name: Deborah Meligne

given: Deborah

family: Sommet

full_name: Agnes Sommet

given: Agnes

family: Salabert

full_name: Anne S. Salabert

given: Anne S.

family: Guillaume

full_name: Sebastien Guillaume

given: Sebastien

family: Courtet

full_name: Philippe Courtet

given: Philippe

family: Galtier

full_name: Florence Galtier

given: Florence

family: Mariano-Goulart

full_name: Denis Mariano-Goulart

given: Denis

family: Champfleur

full_name: Nicolas Menjot De Champfleur

given: Nicolas Menjot De

family: Bars

full_name: Emmanuelle Le Bars

given: Emmanuelle Le

family: Desmidt

full_name: Thomas Desmidt

given: Thomas

family: Lemaire

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Université Toulouse - Jean Jaurès

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Université Francois Rabelais - Tours

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

location_facility: Clinique Psychiatrique Universitaire CHRU Tours


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: 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 Belgium France Switzerland


title: Autologous Transplantation of Adipose Tissue Derived Mesenchymal Stroma/Stem Cells (ASC) in Patients With Critical Limb Ischemia

summary:
Different types of stem cells have recently been studied in clinical trial on ischemic disease of the heart and muscular arteries. Adipose derived stem cell, have shown in vitro and in vivo models a stronger potential of success in recovering from ischemic disease and oxygenation of the tissues. The investigators already shown in a phase I study, that adipose derived mesenchymal cells injected in patients with critical limb ischemia and no option for revascularization, had a very good tolerance and interesting effects on skin oxygenation and healing.

The aim of the present clinical trial is to confirm the efficacy autologous transplantation of adipose tissue derived mesenchymal cells in patients with critical limb ischemia with poor options or no option for revascularization.

lead_sponsor: University Hospital, Toulouse

location_facility:
CHU de LIMOGES
CHU de BORDEAUX
Rangueil Hospital


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: 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.


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.

ReferenceCitation: Allen M, Frank D, Schwarzkopf DS, Fardo F, Winston JS, Hauser TU, Rees G. Unexpected arousal modulates the influence of sensory noise on confidence. Elife. 2016 Oct 25;5. pii: e18103. doi: 10.7554/eLife.18103.

ReferenceCitation: Bagiella E, Sloan RP, Heitjan DF. Mixed-effects models in psychophysiology. Psychophysiology. 2000 Jan;37(1):13-20.

ReferenceCitation: Beck AT, Baruch E, Balter JM, Steer RA, Warman DM. A new instrument for measuring insight: the Beck Cognitive Insight Scale. Schizophr Res. 2004 Jun 1;68(2-3):319-29.

ReferenceCitation: Birchwood M, Smith J, Drury V, Healy J, Macmillan F, Slade M. A self-report Insight Scale for psychosis: reliability, validity and sensitivity to change. Acta Psychiatr Scand. 1994 Jan;89(1):62-7.

ReferenceCitation: Bruno N, Sachs N, Demily C, Franck N, Pacherie E. Delusions and metacognition in patients with schizophrenia. Cogn Neuropsychiatry. 2012;17(1):1-18. doi: 10.1080/13546805.2011.562071. Epub 2011 Jun 28.

ReferenceCitation: Calcagnì A, Lombardi L, Sulpizio S. Analyzing spatial data from mouse tracker methodology: An entropic approach. Behav Res Methods. 2017 Dec;49(6):2012-2030. doi: 10.3758/s13428-016-0839-5.

ReferenceCitation: Charles L, Gaillard R, Amado I, Krebs MO, Bendjemaa N, Dehaene S. Conscious and unconscious performance monitoring: Evidence from patients with schizophrenia. Neuroimage. 2017 Jan 1;144(Pt A):153-163. doi: 10.1016/j.neuroimage.2016.09.056. Epub 2016 Sep 23.

ReferenceCitation: Chaumon M, Bishop DV, Busch NA. A practical guide to the selection of independent components of the electroencephalogram for artifact correction. J Neurosci Methods. 2015 Jul 30;250:47-63. doi: 10.1016/j.jneumeth.2015.02.025. Epub 2015 Mar 16.

ReferenceCitation: Chiu CY, Liu CC, Hwang TJ, Hwu HG, Hua MS. Metamemory in patients with schizophrenia measured by the feeling of knowing. Psychiatry Res. 2015 Dec 15;230(2):511-6. doi: 10.1016/j.psychres.2015.09.046. Epub 2015 Oct 3.

ReferenceCitation: Fleming SM, Dolan RJ, Frith CD. Metacognition: computation, biology and function. Philos Trans R Soc Lond B Biol Sci. 2012 May 19;367(1594):1280-6. doi: 10.1098/rstb.2012.0021.

ReferenceCitation: Fox, J. (2003). Effect displays in R for generalised linear models. Journal of statistical software 8(15): 1-27.

ReferenceCitation: Kay SR, Fiszbein A, Opler LA. The positive and negative syndrome scale (PANSS) for schizophrenia. Schizophr Bull. 1987;13(2):261-76.

ReferenceCitation: Kepecs A, Mainen ZF. A computational framework for the study of confidence in humans and animals. Philos Trans R Soc Lond B Biol Sci. 2012 May 19;367(1594):1322-37. doi: 10.1098/rstb.2012.0037. Review.

ReferenceCitation: Kieslich, P. J., D. U. Wulff, et al. Mousetrap: An R package for processing and analyzing mouse-tracking data (Version 3.0.0). 2017

ReferenceCitation: Koren D, Seidman LJ, Poyurovsky M, Goldsmith M, Viksman P, Zichel S, Klein E. The neuropsychological basis of insight in first-episode schizophrenia: a pilot metacognitive study. Schizophr Res. 2004 Oct 1;70(2-3):195-202.

ReferenceCitation: Köther U, Veckenstedt R, Vitzthum F, Roesch-Ely D, Pfueller U, Scheu F, Moritz S. "Don't give me that look" - overconfidence in false mental state perception in schizophrenia. Psychiatry Res. 2012 Mar 30;196(1):1-8. doi: 10.1016/j.psychres.2012.03.004. Epub 2012 Apr 5.

ReferenceCitation: Kuznetsova, A., P. B. Brockhoff, et al. Package 'lmerTest'. R package version 2. 2015

ReferenceCitation: Lysaker PH, McCormick BP, Snethen G, Buck KD, Hamm JA, Grant M, Nicolò G, Dimaggio G. Metacognition and social function in schizophrenia: associations of mastery with functional skills competence. Schizophr Res. 2011 Sep;131(1-3):214-8. doi: 10.1016/j.schres.2011.06.011. Epub 2011 Jul 13.

ReferenceCitation: Maniscalco B, Lau H. A signal detection theoretic approach for estimating metacognitive sensitivity from confidence ratings. Conscious Cogn. 2012 Mar;21(1):422-30. doi: 10.1016/j.concog.2011.09.021. Epub 2011 Nov 8.

ReferenceCitation: Morey, R. D., J. N. Rouder, et al. BayesFactor: Computation of Bayes factors for common designs. R package version 0.98. 2014.

ReferenceCitation: Moritz S, Woodward TS, Jelinek L, Klinge R. Memory and metamemory in schizophrenia: a liberal acceptance account of psychosis. Psychol Med. 2008 Jun;38(6):825-32. doi: 10.1017/S0033291707002553. Epub 2008 Jan 21.

ReferenceCitation: Nasrallah H, Morosini P, Gagnon DD. Reliability, validity and ability to detect change of the Personal and Social Performance scale in patients with stable schizophrenia. Psychiatry Res. 2008 Nov 30;161(2):213-24. doi: 10.1016/j.psychres.2007.11.012. Epub 2008 Oct 11.

ReferenceCitation: Perrin F, Pernier J, Bertrand O, Echallier JF. Spherical splines for scalp potential and current density mapping. Electroencephalogr Clin Neurophysiol. 1989 Feb;72(2):184-7.

ReferenceCitation: Rausch M, Müller HJ, Zehetleitner M. Metacognitive sensitivity of subjective reports of decisional confidence and visual experience. Conscious Cogn. 2015 Sep;35:192-205. doi: 10.1016/j.concog.2015.02.011. Epub 2015 Mar 7.

ReferenceCitation: Singmann, H., B. Bolker, et al. afex: Analysis of factorial experiments. R package version 0.15-2. 2015.

ReferenceCitation: Team, R. C.R: A language and environment for statistical computing. Vienna: R Foundation for Statistical Computing. 2016.

ReferenceCitation: van der Gaag M, Hoffman T, Remijsen M, Hijman R, de Haan L, van Meijel B, van Harten PN, Valmaggia L, de Hert M, Cuijpers A, Wiersma D. The five-factor model of the Positive and Negative Syndrome Scale II: a ten-fold cross-validation of a revised model. Schizophr Res. 2006 Jul;85(1-3):280-7. Epub 2006 May 26.

ReferenceCitation: Wickham, H. ggplot2: elegant graphics for data analysis, Springer. 2016.

ReferenceCitation: Yeung N, Summerfield C. Metacognition in human decision-making: confidence and error monitoring. Philos Trans R Soc Lond B Biol Sci. 2012 May 19;367(1594):1310-21. doi: 10.1098/rstb.2011.0416. Review.

lead_sponsor: Versailles Hospital

location_facility:
CH Alpes Isère
CHU Grenoble
Centre Hospitalier de Versailles


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


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

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.

ReferenceCitation: Magalhães 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.

ReferenceCitation: Ananworanich J, Nuesch R, Côté 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. Review.

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. Review.

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 Trilège induction-maintenance trial: results at 18 months. AIDS. 2002 Mar 8;16(4):561-8.

ReferenceCitation: Bowersox J. ACTG 343: three drugs better than two for maintaining HIV suppression. NIAID AIDS Agenda. 1998 Mar:1-2, 10-1.

ReferenceCitation: Arribas JR, Girard PM, Landman R, Pich J, Mallolas J, Martínez-Rebollar M, Zamora FX, Estrada V, Crespo M, Podzamczer D, Portilla J, Dronda F, Iribarren JA, Domingo P, Pulido F, Montero M, Knobel H, Cabié 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, Suárez-Lozano I, Riera M, Estébanez M, Palacios R, Sanz-Moreno J, Troya J, Mariño 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. 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, Focà 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, Pérez-Valero I, Palacios R, Iribarren JA, Payeras A, Domingo P, Sanz J, Cervero M, Curran A, Rodríguez-Gómez FJ, Téllez 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;:.

family: Llibre

full_name: Josep M Llibre

given: Josep M

family: Hung

full_name: Chien-Ching Hung

given: Chien-Ching

family: Brinson

full_name: Cynthia Brinson

given: Cynthia

family: Castelli

full_name: Francesco Castelli

given: Francesco

family: Girard

full_name: Pierre-Marie Girard

given: Pierre-Marie

family: Kahl

full_name: Lesley P Kahl

given: Lesley P

family: Blair

full_name: Elizabeth A Blair

given: Elizabeth A

family: Angelis

full_name: Kostas Angelis

given: Kostas

family: Wynne

full_name: Brian Wynne

given: Brian

family: Vandermeulen

full_name: Kati Vandermeulen

given: Kati

family: Underwood

full_name: Mark Underwood

given: Mark

family: Smith

full_name: Kim Smith

given: Kim

family: Gartland

full_name: Martin Gartland

given: Martin

family: Aboud

full_name: Michael Aboud

given: Michael

journal_name: The Lancet

ReferenceCitation: Katlama C, Assoumou L, Valantin MA, Soulié C, Martinez E, Béniguel 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, Cabié 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. Epub 2001 Dec 4.

ReferenceCitation: Dybul M, Nies-Kraske E, Dewar R, Maldarelli F, Hallahan CW, Daucher M, Piscitelli SC, Ehler L, Weigand A, Palmer S, Metcalf JA, Davey RT, Rock Kress DM, Powers A, Beck I, Frenkel L, Baseler M, Coffin J, Fauci AS. A proof-of-concept study of short-cycle intermittent antiretroviral therapy with a once-daily regimen of didanosine, lamivudine, and efavirenz for the treatment of chronic HIV infection. J Infect Dis. 2004 Jun 1;189(11):1974-82. Epub 2004 May 10.

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.

ReferenceCitation: Cohen C, Colson A, Pierone G. The FOTO study: Twenty-Four week results support the safety of a two day break on efavirenz-based antiretroviral therapy. Presented at: Ninth International Congress on Drug Therapy in HIV Infection; November 8-13, 2008; Glasgow, UK

ReferenceCitation: Cohen C, Colson A, Pierone G, et al. The FOTO study: The 48 week extension to assess durability of the strategy of taking efavirenz, tenofovir and emtricitabine Five days On, Two days Off (FOTO) each week in virologically suppressed patients. Presented at: Fifth International AIDS Society Conference on HIV Pathogenesis, Treatment, and Prevention; July 19-22, 2009; Cape Town, South Africa

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 Dû 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.

name: Hôpitaux Universitaires Paris-Ile de France-Ouest, Hôpital Raymond Poincaré APHP, Garches, Université Versailles-Saint-Quentin, France

family: de Truchis

full_name: Pierre de Truchis

given: Pierre

name: Sorbonne Universités, INSERM, UPMC Université Paris 06, Institut Pierre Louis d’Epidémiologie et de Santé Publique (IPLESP UMRS 1136), Paris, France

family: Assoumou

full_name: Lambert Assoumou

given: Lambert

name: Institut de Médecine et Epidémiologie Appliquée, Hôpital Bichat, Université Paris 7, Paris, France

name: IAME, UMR 1137, Université Paris Diderot, Sorbonne Paris Cité, AP-HP, Hôpital Bichat-Claude Bernard, Service de Maladies Infectieuses et Tropicales, Paris, France

name: APHP, Hôpital Pitié-Salpétrière, Service Maladies Infectieuses et Tropicales, Paris, France

name: Centre Hospitalier Universitaire Bretonneau, Tours, France

name: APHP, Centre Hospitalier Universitaire Avicenne, APHP, Bobigny 93, France

name: Université Paris Sorbonne-Diderot, EA 7334, APHP Hotel-Dieu, URC-ECO, Paris, France

name: APHP Hôpital R Poincaré, Département de Pharmacologie, Inserm U-1173, Université Paris-Ile de France Ouest, Garches 92, France

name: INSERM U1043/CNRS5282, Université de Toulouse, CHU Purpan, Toulouse, France

name: INSERM-ANRS, Agence Nationale pour la Recherche sur le Sida et les Hépatites, Paris, France

name: APHP, Hôpital Saint Antoine, Service Maladies Infectieuses, Paris, France

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: Pogány 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. 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 Saint André/Service HDJ Maladies Infectieuses

location_facility: Hôpital Avicenne/Service des Maladies Infectieuses et tropicales

location_facility: Hôpital Delafontaine/Service des Maladies Infectieuses

location_facility: Hôpital Foch/Service de Médecine Interne

location_facility: Centre Hospitalier René Dubos/Service de Dermatologie

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

location_facility: Hôpital Tenon/Service des Maladies Infectieuses

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

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

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

location_facility: Hôpital Pellegrin/Service des Maladies Infectieuses et Tropicales

location_facility: Hôpital Hôtel Dieu/Unité fonctionnelle de Pathologie Infectieuse

location_facility: Hôpital Gui de Chauliac/Service des Maladies Infectieuses

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

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

location_facility: Hôpital Bichat/Service des Maladies Infectieuses

location_facility: Hôpital Louis Pasteur/Service des Maladies Infectieuses

location_facility: Hôpital Pitié-Salpêtrière/Service des Maladies Infectieuses

location_facility: Hôpital Saint Louis/Service des Maladies Infectieuses

location_facility: Hôpital Côte de Nacre/Service des Maladies Infectieuses

location_facility: Hôpital Bretonneau/Service des Maladies Infectieuses

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

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

location_facility: Hôpital Purpan/Service des Maladies Infectieuses

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

location_facility: Hôpital Robert DEBRE/Service des maladies infectieuses

location_facility: Hôpital François Mitterrand/Service des Maladies Infectieuses

location_facility: Hôpital Raymond Poincaré/Service des Maladies Infectieuses

location_facility: Hôpital Saint Antoine/Service des Maladies Infectieuses

location_facility: Hôpital Lariboisière/Service de Médecine Interne

location_facility: Centre hospitalier de Poissy/Service des Maladies Infectieuses

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

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

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

location_facility: Hôpital Necker/Service des Maladies Infectieuses

location_facility: Hôpital Gustave Dron/Service des Maladies Infectieuses

location_facility: Hôpital Hôtel Dieu/Service d'Immunologie Clinique

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

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.


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.

location_facility:
Montpellier University Hospital
Public Assistance - Marseille Hospitals


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: Yes

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

location_facility: Hôpital Européen Georges Pompidou - APHP

intervention_type: Diagnostic Test


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, Jégou 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.

ReferenceCitation: Le Tortorec A, Le Grand R, Denis H, Satie AP, Mannioui K, Roques P, Maillard A, Daniels S, Jégou 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, Jégou 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. Review.

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. Review.

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 Paris Bichat
CECOS Hôpital Paule de Viguier
CECOS Bretagne Rennes