title: Impact of Transferrin Saturation Guided Maintenance Treatment on Quality of Life in HFE Haemochromatosis

acronym: Quali-SAT

summary: Patients in maintenance treatment for HFE hemochromatosis since at least one year will be included in a two year study period and randomized in two groups experimental and control group. Because proton pump inhibitors are widely used as chronic medication, and because they can significantly modify iron absorption, patients will be stratified according to the use of proton pump inhibitors and gender. A first bloodletting will be performed at inclusion with the same volume as usually performed by the patients. Results of the biological test performed at this visit will guide the time schedule and volume of the next bloodletting according to randomization group (patients treated with bloodletting according to current guidelines "ferritin alone" versus patients treated with bloodletting according to "transferrin saturation and serum ferritin").Blood count and iron metabolism parameters will be performed at each bloodletting and follow-up visits. Time schedule and volume of bloodletting will be adjusted to biological results after each follow-up visit. Volume and schedule for bloodlettings will be determined according to guidelines specifically designed for this study to assure harmonization of treatment management, and centrally validated through the recording of the biological tests in the electronic Case Report Form which will provide the investigator with the volume and schedule of the next bloodletting. There will be two ways of treatment modification: either change of schedule or volume of bloodletting. Patients will undergo follow-up visit every six months with clinical examination, questionnaires at J0, M12 and M24 (SF-36; AIMS2-SF, WOMAC, EQ-5D-5L), and biological test. For health economics analysis, data will be obtained thanks to a dedicated extraction from SNDS database SNDS database will allow to gather hospital stays, visits, and other healthcare-related costs as well as vital status (date (month/year) of death) and cause of death. A de-identified copy of the clinical database, restricted to the relevant variables, will be sent for semideterministic matching purpose with SNDS extraction using four key variables: gender, same date (month/year) of birth, same date (day/month/year) of visit for bloodletting; pending, of course, regulatory authorization.

location_facility:
Hopital Avicenne
CH Yves le Foll
CHU Dupuytren
Hôpital Rangueil
CHR Orléans
Hôpital Paul Brousse
GHRMSA - Hôpital Emile Muller
Centre hospitalier Bretagne Atlantique
GHBS site du Scorff
CHU Rennes
CH de St Malo


type: EudraCT Number

title: What is the Effectiveness and Safety of Mirtazapine Versus Escitalopram in Alleviating Cancer-associated Poly-symptomatology (MIR-P)? A Mixed-method Randomized Controlled Trial Protocol

acronym: MIR-P

summary: Multicenter, prospective, randomized, controlled trial based on a mixed-method methodology using parallel groups, of oral mirtazapine (intervention) compared with oral escitalopram (control), with a 56 days follow-up. Improvement of the Global health Status (issued from the EORTC-QLQ-C30 (Quality of Life Questionnaire)) will be used as the primary outcome on day 56. Semi-structures interviews will be performed on a purposive sample for qualitative analysis. The 418 participants will be followed-up at day 7, 14, 28 and 56 for a 56 days period. A sub-group of participants will be invited to take part into qualitative interviews at baseline and day 56. Recruitment of participants to the qualitative part will be based on a purposive sampling.

study_start_date_type: Anticipated

status: Not yet recruiting

study_completion_date_type: Anticipated

study_type: Interventional

design_allocation: Randomized

primary_purpose: Treatment

enrollment_type: Anticipated

lead_sponsor: Hospices Civils de Lyon

location_facility: Centre Hospitalier Universitaire de Clermont-Ferrand

location_facility: Centre Médico-Chirurgical de Réadaptation des Massues Croix-Rouge française

location_facility: Centre Hospitalier Universitaire de Saint-Etienne

location_facility: Centre Hospitalier Universitaire de Grenoble

intervention_type: Drug

lead_sponsor_type: academique

status_simplified: Ongoing


type: Other Identifier

title: An Open-label, Single Arm, Phase 2 Study of Rituximab, Gemcitabine and Oxaliplatin Plus Enzastaurin as Treatment for Patients With Relapsed Diffuse Large B-Cell Lymphoma

summary:
The primary purpose of this study is to help answer the following research questions:

To assess whether Enzastaurin combined with rituximab, gemcitabine and oxaliplatin (R-GEMOX) can help participants with Diffuse Large B-Cell Lymphoma (DLBCL) remain free from disease and thus live longer.
To assess for any side effects that might be associated with enzastaurin and R-GEMOX .
To look at the characteristics and levels of certain genes and proteins to learn more about DLBCL and how enzastaurin works in the body.
To look at the level of enzastaurin in the body and how long it remains.

status: Completed

study_completion_date_type: Actual

enrollment_type: Actual

lead_sponsor: Eli Lilly and Company

location_country:
Germany
Russian Federation
France

location_facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

lead_sponsor_type: industriel

status_simplified: Completed


title: Validation of Enoxaparin Dose Adaptation in Patients With Moderate Renal Failure Hospitalized for an Acute Coronary Syndrome, the VALIDE Study

summary: The objective of the VALIDE study is to validate that a 25% dose reduction of enoxaparine in patients with moderate renal failure (creatinine clearance between 30 and 50 ml/min) and hospitalized for an acute coronary syndrome provides at steady state a similar anti Xa level in plasma compared to that obtained in patients without renal failure and receiving the usual dose of 1 mg/kg subcutaneously every 12 hours. 140 per - protocol patients are planned to be included.

design_allocation: Non-Randomized

lead_sponsor: French Cardiology Society

location_facility:
CHU Jean MINJOZ
Sud Francilien Hospital center
Ambroise Paré Hospital
CHU Bichat
Henri Mondor Hospital
Lagny center Hospital
Lariboisiére Hospital
Rangueil Hospital
Pitié Salpêtrière Hospital


title: Multicentric Non-randomized Phase II of Pembrolizumab in Combination With Etoposide-cisplatin-based Chemotherapy in First-line Advanced Small Cell Ovarian Carcinoma of Hypercalcemic Type

acronym: PembroSCCOHT

summary: Advanced small cell ovarian carcinomas are rare and have a very poor prognosis affecting a young population. The objective of this study is to increase the efficacy of the initial chemotherapy by providing immunotherapy and to be able to offer to more patients the possibility of benefiting from an intensification of chemotherapy, which is a major prognostic factor in this population.

study_start_date_type: Actual

status: Recruiting

lead_sponsor: ARCAGY/ GINECO GROUP

location_facility: Centre Hospitalier Régional Universitaire de Besançon

location_facility: ICANS - Institut de cancérologie Strasbourg Europe


title: Molecular Profiles Associated With Resistance Development in Cancer Patients. Prospective Exploratory Study From 3 Cancer Locations: TNBC or Locally Advanced or Metastatic, Non-small Cell or Pancreatic or Bronchial Cancers

acronym: OncoSNIPE

summary: Precision medicine is considered to be one of the major issues in patient care. A lot of research has already proven itself with the implementation of targeted therapies including immunotherapies offering patients improved response and survival rates. But despite these major therapeutic advances, resistance to anti-cancer treatment is a major obstacle in the care of patients. Indeed, to date, many patients die of cancer, 9.6 million deaths worldwide in 2018. Nowadays, improving understanding of the mechanisms of resistance of cancer cells to anti-tumor treatments is therefore a major issue. The great diversity of molecular mechanisms involved in the phenomena of resistance to treatment, whether intrinsic (de novo, or primary) or acquired (secondary), constitutes a real therapeutic challenge. Indeed, a better understanding of the mechanisms of resistance would make it possible to explore new therapeutic strategies making it possible to circumvent these phenomena of escape in different types of cancer. It is in this context that the OncoSNIPE project was developed. The objective of this project is to identify early and / or late markers of resistance to treatment in 3 different pathologies concerned with resistance issues: triple negative breast cancer or Lum B or locally advanced or metastatic non -small-cell lung cancer or pancreatic cancer. In this project, in order to best cover the diversity of mechanisms involved in these resistances, the investigators propose a multidisciplinary approach with clinical, genomic, transcriptomic and immunological dimensions of the pathology through the data collected from 600 patients (200 for each pathology) for 4 years

primary_purpose: Other

lead_sponsor: Oncodesign SA

location_facility:
APHP - Hôpital Beaujon
CGFL
Chu de Besancon
Hopitaux Universitaires de Strasbourg
Institut Paoli Calmettes
Chu Dijon Bourgogne
Chu de Poitiers
Institut Curie
Centre Leon Berard
Institut Godinot
Institut de Cancerologie de Lorraine

intervention_type: Other


type: Other Grant/Funding Number

title: Vertebral Osteosynthesis in Degenerative Lumbar Stenosis With Spondylolisthesis - CLEOS Study

acronym: CLEOS

summary: Study to evaluate the superiority of the osteosynthesis associated with a decompressive surgery in comparison with a simple decompressive surgery in the treatment of lumbar degenerative stenosis with spondylolisthesis

status: Terminated

ReferenceType: background

ReferenceCitation: Caputy AJ, Luessenhop AJ. Long-term evaluation of decompressive surgery for degenerative lumbar stenosis. J Neurosurg. 1992 Nov;77(5):669-76. Review.

ReferenceCitation: Cherkin DC, Deyo RA, Loeser JD, Bush T, Waddell G. An international comparison of back surgery rates. Spine (Phila Pa 1976). 1994 Jun 1;19(11):1201-6.

ReferenceCitation: Davis H. Increasing rates of cervical and lumbar spine surgery in the United States, 1979-1990. Spine (Phila Pa 1976). 1994 May 15;19(10):1117-23; discussion 1123-4.

ReferenceCitation: Feffer HL, Wiesel SW, Cuckler JM, Rothman RH. Degenerative spondylolisthesis. To fuse or not to fuse. Spine (Phila Pa 1976). 1985 Apr;10(3):287-9.

ReferenceCitation: Fritzell P, Hägg O, Wessberg P, Nordwall A; Swedish Lumbar Spine Study Group. 2001 Volvo Award Winner in Clinical Studies: Lumbar fusion versus nonsurgical treatment for chronic low back pain: a multicenter randomized controlled trial from the Swedish Lumbar Spine Study Group. Spine (Phila Pa 1976). 2001 Dec 1;26(23):2521-32; discussion 2532-4.

ReferenceCitation: Gibson JN, Grant IC, Waddell G. The Cochrane review of surgery for lumbar disc prolapse and degenerative lumbar spondylosis. Spine (Phila Pa 1976). 1999 Sep 1;24(17):1820-32.

lead_sponsor: University Hospital, Toulouse

location_facility: Toulouse University Hospital - Purpan - Neurosurgery department

location_facility: University Hospital of Besançon - Neurosurgey department

location_facility: Toulouse University Hospital - Rangueil- Neuro surgery department

location_facility: University Hospital of Caen - Neurosurgery department

location_facility: University Hospital of Saint-Etienne - Neurosurgery department

location_facility: University Hospital of Nice - Neurosurgery department

intervention_type: Procedure

status_simplified: Unknown


title: TIL (Tumor Infiltrating Lymphocytes) and IL2 (Interleukin 2) Versus Abstention as Adjuvant Treatment in Melanoma With Only One Invaded Lymphnode After Lymphnodes Excision

acronym: TIL

summary: The objective of this multicentric Phase III study is to confirm the results of the phase I-II study (Dreno B & Al. Cancer Immunol Immunother 2002; 51: 539-456) which demonstrated the preventive effect of a treatment by TIL (Tumor Infiltrating Lymphocytes) combined with IL2 (Interleukin 2; low dose injected subcutaneously) on the metastatic relapse in the stage III melanoma patients with only one invaded lymphnode.

lead_sponsor: Nantes University Hospital

location_facility:
CHU Angers
Montpellier University Hospital
CH Le Mans
CHU Poitiers
CHU Caen
Grenoble University Hospital
Nantes University Hospital
CHU Rennes
CHRU Tours


title: Evaluation of the Therapeutic Effects of Escitalopram in Pulmonary Hypertension, Either Primary or Associated

summary: This is a Phase III, multicenter, randomized, double-blind, placebo-controlled study to evaluate the efficacy of escitalopram (30 mg/day) in two parallel groups (randomization ratio, escitalopram 2/placebo 1).

lead_sponsor: Assistance Publique - Hôpitaux de Paris

location_facility:
Louis Pradel Hospital
Michallon Hospital
Henri Mondor Hospital
Sainte Marguerite Hospital
Hautepierre Hospital
Rangueil Hospital
Antoine Beclere Hospital
Brabois Hospital
Haut Lévèque Hospital


title: LEft Main Oct Guided iNterventions

acronym: LEMON

summary: LEMON aim is to evaluate the feasibility, efficiency and security of a standardized Optical Coherence Tomography (OCT) - guided protocol for completion and optimization of Left Main (LM) Percutaneous Coronary Intervention (PCI).

ipd_sharing: No

lead_sponsor: Institut Mutualiste Montsouris

location_facility:
Chu Besancon
Institut hospitalier Jacques Cartier
CHU Nîmes
Ch Chartres
Clinique Saint Hilaire
Chu Clermont Ferrand
Hôpital privé Saint Martin
Ch Annecy Genevois
Clinique Saint Augustin
Chu Bordeaux
Institut Mutualiste Montsouris


title: Phase II Trial Assessing the Impact on the Activity of Daily Living of an Oral Chemotherapy by Capecitabine Associated With an Intravenous Chemotherapy by Oxaliplatin as First Line Treatment of Metastatic Colorectal Adenocarcinoma of Patients Aged Over 70

summary:
RATIONALE: Drugs used in chemotherapy, such as capecitabine and oxaliplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing.

PURPOSE: This phase II trial is studying how well giving capecitabine together with oxaliplatin works in treating older patients with metastatic colorectal cancer.

ReferenceType: result

ReferenceCitation: Viret F, Bugat R, Ducreux M, et al.: XELOX regimen in elderly patients with metastatic colorectal cancer (MCRC), a FNCLCC French Collaborative Group GERICO 02 phase II study. [Abstract] J Clin Oncol 25 (Suppl 18): A-19513, 708s, 2007.

lead_sponsor: UNICANCER

location_facility: Marseille Institute of Cancer - Institut J. Paoli and I. Calmettes


title: Neuromuscular Blockade in the Intentive Care Unit, an Observational Study.

acronym: CURATIV

summary:
The study Short description of the protocol intended for the lay public. Include a brief statement of the study hypothesis. (Limit: 5000 characters) Neuromuscular blocking agents (NMBAs) are drug capable of inducing a complete paralysis of the muscle. Their use is frequent in the intensive care unit (ICU). Most of the time it is used as a single infusion to facilitate endotracheal intubation, but in the ICU the use of continuous infusion is common in several pathologies: acute distress respiratory syndrome, post-cardiac arrest survivor under hypothermia to prevent shivering, abdominal compartment syndrome, severe traumatic brain injury with uncontrolled intra-cranial pressure and severe asthma among others.

A monitoring of the dose of NMBAs is recommended to guide the depth of paralysis and to guide recovery, but in the ICU, the interest of such a monitoring during continuous infusion is unclear and the level of evidence is low.

The investigators propose to conduct a prospective multicentric observational study to describe the current practice in the use of NMBAs in mechanically ventilated patients in the ICU. As a primary objective we will describe the prevalence of NMBAs use in the ICU. As a secondary objective, the investigators will investigate the impact of protocol and/or monitoring devices of NMBAs on the dose administered and clinical outcome endpoints.

status: Active, not recruiting

study_type: Observational

time_perspective: Prospective

ReferenceCitation: Arroliga A, Frutos-Vivar F, Hall J, Esteban A, Apezteguía C, Soto L, Anzueto A; International Mechanical Ventilation Study Group. Use of sedatives and neuromuscular blockers in a cohort of patients receiving mechanical ventilation. Chest. 2005 Aug;128(2):496-506.

ReferenceCitation: Arroliga AC, Thompson BT, Ancukiewicz M, Gonzales JP, Guntupalli KK, Park PK, Wiedemann HP, Anzueto A; Acute Respiratory Distress Syndrome Network. Use of sedatives, opioids, and neuromuscular blocking agents in patients with acute lung injury and acute respiratory distress syndrome. Crit Care Med. 2008 Apr;36(4):1083-8. doi: 10.1097/CCM.0B013E3181653895.

ReferenceCitation: Bellani G, Laffey JG, Pham T, Fan E, Brochard L, Esteban A, Gattinoni L, van Haren F, Larsson A, McAuley DF, Ranieri M, Rubenfeld G, Thompson BT, Wrigge H, Slutsky AS, Pesenti A; LUNG SAFE Investigators; ESICM Trials Group. Epidemiology, Patterns of Care, and Mortality for Patients With Acute Respiratory Distress Syndrome in Intensive Care Units in 50 Countries. JAMA. 2016 Feb 23;315(8):788-800. doi: 10.1001/jama.2016.0291. Erratum in: JAMA. 2016 Jul 19;316(3):350. JAMA. 2016 Jul 19;316(3):350.

name: School of Medicine and Surgery, University of Milan-Bicocca, Monza, Italy2Department of Emergency and Intensive Care, San Gerardo Hospital, Monza, Italy

family: Bellani

full_name: Giacomo Bellani

given: Giacomo

sequence: first

name: Departments of Anesthesia and Critical Care Medicine, Keenan Research Centre for Biomedical Science, St Michael’s Hospital4Departments of Anesthesia, Physiology and Interdepartmental division of Critical Care Medicine, University of Toronto, Canada

family: Laffey

full_name: John G. Laffey

given: John G.

sequence: additional

name: AP-HP, Hôpital Tenon, Unité de Réanimation médico-chirurgicale, Pôle Thorax Voies aériennes, Groupe hospitalier des Hôpitaux Universitaires de l’Est Parisien, Paris, France6UMR 1153, Inserm, Sorbonne Paris Cité, ECSTRA Team, Université Paris Diderot, Pari

family: Pham

full_name: Tài Pham

given: Tài

name: Department of Medicine, University Health Network and Mount Sinai Hospital9Interdepartmental Division of Critical Care Medicine and Institute of Health Policy, Management and Evaluation, University of Toronto, Toronto, Canada

family: Fan

full_name: Eddy Fan

given: Eddy

name: Keenan Research Centre, Li Ka Shing Knowledge Institute, St Michael’s Hospital, Toronto, Canada11Interdepartmental Division of Critical Care Medicine, University of Toronto, Toronto, Canada

family: Brochard

full_name: Laurent Brochard

given: Laurent

name: Hospital Universitario de Getafe, CIBER de Enfermedades Respiratorias, Madrid, Spain

family: Esteban

full_name: Andres Esteban

given: Andres

name: Istituto di Anestesia e Rianimazione, Università degli Studi di Milano, Ospedale Maggiore, Istituto di Ricovero e Cura a Carattere Scientifico, Milan, Italy

family: Gattinoni

full_name: Luciano Gattinoni

given: Luciano

name: Intensive Care Unit, Canberra Hospital, and Australian National University, Canberra, Australia

family: van Haren

full_name: Frank van Haren

given: Frank

name: Section of Anesthesiology and Intensive Care, Department of Surgical Sciences, Uppsala University, Uppsala, Sweden

family: Larsson

full_name: Anders Larsson

given: Anders

name: Centre for Experimental Medicine, Queen's University of Belfast, Belfast, Northern Ireland17Wellcome-Wolfson Institute for Experimental Medicine, Belfast, Northern Ireland18Regional Intensive Care Unit, Royal Victoria Hospital, Grosvenor Road, Belfast, No

family: McAuley

full_name: Daniel F. McAuley

given: Daniel F.

name: SAPIENZA Università di ROMA, Dipartimento di Anestesia e Rianimazione, Policlinico Umberto I, Viale del Policlinico 155, 00161 Roma, Italy

family: Ranieri

full_name: Marco Ranieri

given: Marco

name: Interdepartmental Division of Critical Care Medicine, University of Toronto, Toronto, Canada21Program in Trauma, Emergency and Critical Care, Sunnybrook Health Sciences Center, Toronto, Canada

family: Rubenfeld

full_name: Gordon Rubenfeld

given: Gordon

name: Division of Pulmonary and Critical Care Unit, Department of Medicine, Massachusetts General Hospital, Harvard Medical School, Boston

family: Thompson

full_name: B. Taylor Thompson

given: B. Taylor

name: Department of Anesthesiology and Intensive Care Medicine, University of Leipzig, Liebigstr. 20, D-04103 Leipzig, Germany

family: Wrigge

full_name: Hermann Wrigge

given: Hermann

name: Keenan Research Center at the Li Ka Shing Knowledge Institute of St Michael’s Hospital, the Interdepartmental Division of Critical Care Medicine, and the Department of Medicine, University of Toronto, Toronto, Canada

family: Slutsky

full_name: Arthur S. Slutsky

given: Arthur S.

family: Pesenti

full_name: Antonio Pesenti

given: Antonio

name: for the LUNG SAFE Investigators and the ESICM Trials Group

bso_classification: Medical research

datasource: user

genre: journal-article

genre_raw: journal-article

journal_name: JAMA

oa_colors: green hybrid

oa_host_type: publisher;repository

evidence: open (via free pdf)

host_type: publisher

license_normalized: no license

version: publishedVersion

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

host_type: repository

repository_institution: Queen's University Belfast - Research Portal

publisher: American Medical Association (AMA)

publisher_dissemination: American Medical Association

publisher_group: American Medical Association

publisher_normalized: American Medical Association

ReferenceCitation: Papazian L, Forel JM, Gacouin A, Penot-Ragon C, Perrin G, Loundou A, Jaber S, Arnal JM, Perez D, Seghboyan JM, Constantin JM, Courant P, Lefrant JY, Guérin C, Prat G, Morange S, Roch A; ACURASYS Study Investigators. Neuromuscular blockers in early acute respiratory distress syndrome. N Engl J Med. 2010 Sep 16;363(12):1107-16. doi: 10.1056/NEJMoa1005372.

family: Papazian

title: Neuromuscular Blockers in Early Acute Respiratory Distress Syndrome

ReferenceCitation: Lascarrou JB, Le Gouge A, Dimet J, Lacherade JC, Martin-Lefèvre L, Fiancette M, Vinatier I, Lebert C, Bachoumas K, Yehia A, Lagarrigue MH, Colin G, Reignier J. Neuromuscular blockade during therapeutic hypothermia after cardiac arrest: observational study of neurological and infectious outcomes. Resuscitation. 2014 Sep;85(9):1257-62. doi: 10.1016/j.resuscitation.2014.05.017. Epub 2014 Jun 2.

ipd_sharing_description: IPD can be obtained from PI after careful evaluation of request by clinical research committee of the French Intensive Care Society

location_facility:
CHRU Bretonneau
CHD Les Oudairies
CH d'Argenteuil
CH Le Mans
CHU La Pitié Salpétrière
CHR Orléans
CH de Versailles
CHU Nantes
CHU Nimes
CH de Pontoise
CHU Kremlin-Bicetre


title: Analgesic Efficacy of Hypnosis and Virtual Reality in Repetitive Pain Care : a Controlled, Randomised, Cross-over, Open-label, Multi-centre Study

acronym: PADIS

summary: The originality of this study is the comparison of different distractibility techniques (hypnosis and virtual reality) in the very heterogenous contexts of pain management. This study will consider all types of care situations. The study's cross-over design will take into account this heterogenous context. The results will be representative of real-life situations where care for pain involves a wide range of contexts.

primary_purpose: Supportive Care

lead_sponsor: Lille Catholic University

location_facility: Fondation Ellen Poidatz - Centre de Rééducation Fonctionnelle


intervention_type: Radiation

ipd_sharing_description: Unicancer will share de-identified individual data that underlie the results reported. A decision concerning the sharing of other study documents, including protocol and statistical analysis plan will be examined upon request.

acronym: IMMUNEBOOST

location_facility: Institut de cancerologie de Lorraine Alexis Vautrin

ipd_sharing: Yes

source: euctr

title: A Multicenter, Randomized, Open Label, Phase II Study Evaluating the Feasibility and Tolerance of Nivolumab Neoadjuvant Immunotherapy in High Risk HPV Driven Oropharynx Cancer

summary: The aim of this research is to study the feasibility of neoadjuvant treatment before chemoradiation in "high risk" HPV-driven Oropharynx cancer


title: Comprehensive Chromosomal Testing of Trophectoderm Biopsies of Blastocysts to Improve Live Birth Rates After in Vitro Fertilization: a Prospective Randomized Trial

acronym: Devit

summary:
Preimplantation embryo aneuploidy is a major source of adverse outcomes in human reproduction since it leads to implantation failure, early pregnancy loss or severe chromosomal diseases. The risk of embryos aneuploidy is drastically increased after 35 years old. The intra uterine transfer of euploid embryos assessed through such techniques as next-generation sequencing (NGS) based Comprehensive chromosomal Testing of Trophectoderm (TE) biopsies of Blastocysts (CTTEB), may improve implantation and live birth rates, and decrease miscarriage rates. But no randomized controlled trial (RCT) was ever performed to test the interest of CTTEB for women that really needed it (≥35 to ≤ 41 years old). In this multicentre randomized-controlled-trial, the investigators will compare live birth rate obtained after the first single frozen-thawed blastocyst transfer cycle following the freeze-all-Intracytoplasmic sperm injection cycle in infertile and old couples between two different strategies of Day 5/6 blastocyst selection:

Control group: morphological criteria (Istanbul consensus)
Interventional group: international recommendations after CTTEB (www.pgdis.org; Newsletter May 27, 2019).

location_facility:
CHU Strasbourg
Hôpital Arnaud de Villeneuve
Hôpital Antoine Béclère
CHU Clermont-Ferrand
Hôpital Cochin
CHU Dijon
CHU Nantes
Hopital Tenon


title: Comparison of the Efficacy and Safety of Budesonide/Formoterol Turbuhaler® Versus Terbutaline Nebulization as Reliever Therapy in Children With Asthma Presenting at the Emergency Room for Moderate Exacerbation

acronym: ASTHMAFAST

summary: Combined use of inhaled corticosteroids and long-acting β-agonists (LABAs) as the controller and the quick relief therapy termed single maintenance and reliever therapy (SMART) is a potential therapeutic regimen for the management of persistent asthma. A recent systematic review supports the combined use of inhaled corticosteroids and LABA as both the controller and quick relief therapy (SMART) among patients aged 12 years. In Emergency room (ER), Meta-analysis showed that using salbutamol (or albuterol) by meter doses inhaler (MDI) with a valved holding chamber (VHC) in children with moderate-severe acute asthma exacerbation was more effective, that is, fewer hospital admissions, more clinical improvement, and had fewer adverse effects (tremor and tachycardia) than salbutamol by nebulizer. Therefore, several international guidelines recommend the use of salbutamol by MDI rather than by nebulizer for moderate-severe asthma exacerbations. In children older than 8 years old, dry-powder inhaler (DPI), a device that delivers medication to the lungs in the form of a dry powder is currently used for maintenance and reliever therapy rather than MDI. In this context, we aim to assess the use of combined inhaled corticosteroids and long-acting β-agonists (LABAs) as a quick relief therapy in children older than 8 years old presenting at the ER with moderate asthma exacerbation. Acute asthma patients who had severe exacerbation were excluded from this study (these patients receiving systematically continuous nebulized salbutamol and/or intravenous salbutamol upon their arrival)

lead_sponsor: Centre Hospitalier Intercommunal Creteil

location_facility:
CHU Ambroise Paré
CHI Créteil
CHU Bicêtre
CHI Villeneuve-Saint-Georges
CHU Antoine Béclère
Grand Hôpital de l'Est Francilien
CHU Lille
Centre Hospitalier Sud Francilien


title: A Randomised Active-controlled Study to Compare Efficacy & Safety of Inhaled Isoflurane Delivered by the AnaConDa-S (Anaesthetic Conserving Device) vs IV Midazolam for Sedation in Mechanically Ventilated Paediatric Patients 3-17 Years Old

acronym: IsoCOMFORT

summary: This is a study to compare safety and efficacy of inhaled isoflurane delivered by the AnaConDa-S versus intravenous midazolam for sedation in mechanically ventilated children admitted to an intensive care unit.

ReferenceCitation: Eifinger F, Hünseler C, Roth B, Vierzig A, Oberthuer A, Mehler K, Kribs A, Menzel C, Trieschmann U. Observations on the effects of inhaled isoflurane in long-term sedation of critically Ill children using a modified AnaConDa©-system. Klin Padiatr. 2013 Jul;225(4):206-11. doi: 10.1055/s-0033-1345173. Epub 2013 Jun 24.

ReferenceCitation: Ariyama J, Hayashida M, Shibata K, Sugimoto Y, Imanishi H, O-oi Y, Kitamura A. Risk factors for the development of reversible psychomotor dysfunction following prolonged isoflurane inhalation in the general intensive care unit. J Clin Anesth. 2009 Dec;21(8):567-73. doi: 10.1016/j.jclinane.2009.01.011.

ReferenceCitation: Grant MJ, Balas MC, Curley MA; RESTORE Investigative Team. Defining sedation-related adverse events in the pediatric intensive care unit. Heart Lung. 2013 May-Jun;42(3):171-6. doi: 10.1016/j.hrtlng.2013.02.004. Review.

ReferenceCitation: Hoemberg M, Vierzig A, Roth B, Eifinger F. Plasma fluoride concentrations during prolonged administration of isoflurane to a pediatric patient requiring renal replacement therapy. Paediatr Anaesth. 2012 Apr;22(4):412-3. doi: 10.1111/j.1460-9592.2012.03814.x.

ReferenceCitation: Kruessell MA, Udink ten Cate FE, Kraus AJ, Roth B, Trieschmann U. Use of propofol in pediatric intensive care units: a national survey in Germany. Pediatr Crit Care Med. 2012 May;13(3):e150-4. doi: 10.1097/PCC.0b013e3182388a95.

ReferenceCitation: Kudchadkar SR, Yaster M, Punjabi NM. Sedation, sleep promotion, and delirium screening practices in the care of mechanically ventilated children: a wake-up call for the pediatric critical care community*. Crit Care Med. 2014 Jul;42(7):1592-600. doi: 10.1097/CCM.0000000000000326.

ReferenceCitation: Nolent P, Laudenbach V. [Sedation and analgesia in the paediatric intensive care unit]. Ann Fr Anesth Reanim. 2008 Jul-Aug;27(7-8):623-32. doi: 10.1016/j.annfar.2008.04.014. Epub 2008 Jul 9. French.

ReferenceCitation: Meiser A, Laubenthal H. Inhalational anaesthetics in the ICU: theory and practice of inhalational sedation in the ICU, economics, risk-benefit. Best Pract Res Clin Anaesthesiol. 2005 Sep;19(3):523-38. Review.

ReferenceCitation: Meyburg J, Dill ML, von Haken R, Picardi S, Westhoff JH, Silver G, Traube C. Risk Factors for the Development of Postoperative Delirium in Pediatric Intensive Care Patients. Pediatr Crit Care Med. 2018 Oct;19(10):e514-e521. doi: 10.1097/PCC.0000000000001681.

ReferenceCitation: Mody K, Kaur S, Mauer EA, Gerber LM, Greenwald BM, Silver G, Traube C. Benzodiazepines and Development of Delirium in Critically Ill Children: Estimating the Causal Effect. Crit Care Med. 2018 Sep;46(9):1486-1491. doi: 10.1097/CCM.0000000000003194.

ReferenceCitation: Playfor S, Jenkins I, Boyles C, Choonara I, Davies G, Haywood T, Hinson G, Mayer A, Morton N, Ralph T, Wolf A; United Kingdom Paediatric Intensive Care Society Sedation; Analgesia and Neuromuscular Blockade Working Group. Consensus guidelines on sedation and analgesia in critically ill children. Intensive Care Med. 2006 Aug;32(8):1125-36. Epub 2006 May 13.

ReferenceCitation: Sackey PV, Martling CR, Granath F, Radell PJ. Prolonged isoflurane sedation of intensive care unit patients with the Anesthetic Conserving Device. Crit Care Med. 2004 Nov;32(11):2241-6.

ReferenceCitation: Sackey PV, Martling CR, Radell PJ. Three cases of PICU sedation with isoflurane delivered by the 'AnaConDa'. Paediatr Anaesth. 2005 Oct;15(10):879-85.

ReferenceCitation: Tobias JD. Tolerance, withdrawal, and physical dependency after long-term sedation and analgesia of children in the pediatric intensive care unit. Crit Care Med. 2000 Jun;28(6):2122-32. Review.

ReferenceCitation: Vet NJ, Ista E, de Wildt SN, van Dijk M, Tibboel D, de Hoog M. Optimal sedation in pediatric intensive care patients: a systematic review. Intensive Care Med. 2013 Sep;39(9):1524-34. doi: 10.1007/s00134-013-2971-3. Epub 2013 Jun 19. Review.

lead_sponsor: Sedana Medical

location_country: Germany Sweden France Spain

location_facility: Hôpitaux Universitaires de Strasbourg Hôpital de Hautepierre

location_facility: Hôpitaux Universitaires Paris Sud Site Bicetre

location_facility: Hospital Universitario Virgen del Rocio de Sevilla

location_facility: Hôpitaux Universitaires Est Parisien Trousseau La Roche-Guyon

location_facility: Hospital General Universitario Gregorio Marañón

location_facility: Hospital Universitari i Politecnic La Fe

location_facility: Centre Hospitalier Universitaire de Reims

location_facility: Hopital Universitaire Necker Enfants Malades

location_facility: Hospital Regional Universitario, Carlos Haya

location_facility: Hospital Materno Infantil Sant Joan de Deu Hospital


title: Long-term Outcome After Heparin and Edoxaban Versus Heparin Plus Vitamin K Antagonists for Acute Deep Vein Thrombosis and Pulmonary Embolism HOKUSAÏ POST VT

summary: Centers that participated in the HOKUSAI VTE trial will be invited to collect follow of previously enrolled patients at least 2 years after the index VTE.

lead_sponsor: University Hospital, Montpellier

location_facility:
Montpellier University Hospital
APHP Hôpital Européen Georges Pompidou
Strasbourg University Hospital
Brest University Hospital
Dijon University Hospital
Clermont-Ferrand University Hospital
Le Mans Hospital
Grenoble University Hospital
Nice University Hospital
Amiens University Hospital
Angers University Hospital


title: A Post-Market Study of Performance and Safety of Low-flow Extracorporeal Carbon Dioxide Removal Using PrismaLung+ in Patients With Mild to Moderate Acute Respiratory Distress Syndrome

summary: PrismaLung+ is indicated to provide extracorporeal carbon dioxide removal (ECCO2R) as a stand-alone therapy or in combination with continuous renal replacement therapy (CRRT). This study is intended for patients with increased levels of Carbon Dioxide (CO2) in their blood and ≥ 18 years old, and will treat patients with mild or moderate acute respiratory distress syndrome (ARDS) using PrismaLung+. The study will assess tidal volume reduction and confirm the safety of PrismaLung+.

lead_sponsor: Baxter Healthcare Corporation

intervention_type: Device


title: Relapse in Previously Irradiated Prostate Bed : a Phase I/II Study of Stereotactic Ablative Reirradiation Potentiated by Metformin

summary: This phase I/II escalation dose study is assessing the efficacy of the recommended dose of stereotactic re-irradiation (SBRT) of relapses within the prostatectomy bed, potentiated by metformin

lead_sponsor: Institut Cancerologie de l'Ouest

location_facility:
Chru Bretonneau
Centre Eugene Marquis
Institut de Cancerologie de L'Ouest
Centre GEORGES FRANCOIS LECLERC
Centre OSCAR LAMBRET
Centre LEON BERARD
CHRU de BREST - HOPITAL MORVAN


title: ProAdrenomedullin Assessment of Multi-Organ Failure in COvid-19 Sepsis

acronym: PAMOCOS

summary: COVID-19 is a worldwide pandemic. Around 5% of infected patients are admitted in ICU, mainly for respiratory failure. Outcome of these patients is linked to other organ failures. Optimal therapies are not defined so far. The sponsor want to assess the role of MR-ProADM as prognostic biomarker, and the impact of treatments (including supportive treatments) on MOF occurrence and outcome.

lead_sponsor: Centre Hospitalier de Lens

location_facility:
Hospital of Roubaix
Hospital of Arras
Hospital of Dunkerque
Hospital of Tourcoing
Hospital Dr Schaffner
Hospitalier of Valenciennes
Hospital of DOUAI
Hospital of Boulogne/mer


title: Validation Study on Eye Rubbing Questionnaire in Patients With or Suspected of Having a Keratoconus (KC)

acronym: QFK

summary:
KC is a degenerative disorder of the cornea. Keratoconus etiopathogenesis remains unclear and may rely on environmental and genetic factors. Usually considered as a rare disease (<1/2000), but the prevalence is nowadays growing worldwide up to 1/500. In that pathology, cornea progressively gets thinner, and there is a deformation of the corneal surface which can induce high order optical aberrations and visual impairment.

Eye rubbing is certainly the main factor in the progression or development of keratoconus (KC), yet it is only very partially evaluated and quantified in current management. Environmental and clinical factors will be collected and associated with a eye rubbing Questionnaire, specifically pointing out eye rubbing.

primary_purpose: Prevention

lead_sponsor: University Hospital, Bordeaux

location_facility: Centre National Ophtalmologique des Quinze Vingt


title: Evaluation of Tolerance and Efficacy Retrospective Data of XOFIGO Prescribed by AMM in Prostate Cancer

acronym: XOFIGO

summary:
Since 13 November 2013, XOFIGO has been authorised on the European zone for the treatment of patients with prostate cancer, in the phase of resistance to castration, with symptomatic bone metastases.

bone metastases frequently give rise to "bone events" that include spinal cord compressions and pathological fractures requiring surgery or external radiotherapy.

Bone metastases are an important cause of death, disability, quality of life degradation and increase the cost of treatment.

Xofigo is indicated in patients with bone metastases symptomatic of hormone-resistant prostate cancer and without known visceral metastases.

time_perspective: Retrospective

ReferenceCitation: Harrison MR, Wong TZ, Armstrong AJ, George DJ. Radium-223 chloride: a potential new treatment for castration-resistant prostate cancer patients with metastatic bone disease. Cancer Manag Res. 2013;5:1-14. doi: 10.2147/CMAR.S25537. Epub 2013 Jan 8.

family: Harrison

full_name: Harrison

family: George

full_name: Daniel George

given: Daniel

family: Wong

full_name: Wong

family: Armstrong

full_name: Andrew Armstrong

given: Andrew

currency_apc_doaj: USD

journal_name: Cancer Management and Research

oa_colors: green gold

evidence: oa journal (via doaj)

license: cc-by-nc

license_normalized: cc-by-nc

license: implied-oa

license_normalized: implied-oa

repository_institution: PubMed Central - Europe PMC

repository_normalized: PubMed Central

evidence: oa repository (via pmcid lookup)

evidence: oa repository (semantic scholar lookup)

version: submittedVersion

publisher: Informa UK Limited

publisher_dissemination: Informa

publisher_group: Informa

publisher_normalized: Informa

ReferenceCitation: Nilsson S, Strang P, Aksnes AK, Franzèn L, Olivier P, Pecking A, Staffurth J, Vasanthan S, Andersson C, Bruland ØS. A randomized, dose-response, multicenter phase II study of radium-223 chloride for the palliation of painful bone metastases in patients with castration-resistant prostate cancer. Eur J Cancer. 2012 Mar;48(5):678-86. doi: 10.1016/j.ejca.2011.12.023. Epub 2012 Feb 15. Review.

family: Nilsson

full_name: S. Nilsson

given: S.

family: Strang

full_name: P. Strang

given: P.

family: Aksnes

full_name: A.K. Aksnes

family: Franzèn

full_name: L. Franzèn

given: L.

family: Olivier

full_name: P. Olivier

family: Pecking

full_name: A. Pecking

given: A.

family: Staffurth

full_name: J. Staffurth

given: J.

family: Vasanthan

full_name: S. Vasanthan

family: Andersson

full_name: C. Andersson

given: C.

family: Bruland

full_name: Ø.S. Bruland

journal_name: European Journal of Cancer

oa_host_type: publisher

title: A randomized, dose–response, multicenter phase II study of radium-223 chloride for the palliation of painful bone metastases in patients with castration-resistant prostate cancer

ReferenceCitation: Parker CC, Pascoe S, Chodacki A, O'Sullivan JM, Germá JR, O'Bryan-Tear CG, Haider T, Hoskin P. A randomized, double-blind, dose-finding, multicenter, phase 2 study of radium chloride (Ra 223) in patients with bone metastases and castration-resistant prostate cancer. Eur Urol. 2013 Feb;63(2):189-97. doi: 10.1016/j.eururo.2012.09.008. Epub 2012 Sep 13.

title: A Randomized, Double-Blind, Dose-Finding, Multicenter, Phase 2 Study of Radium Chloride (Ra 223) in Patients with Bone Metastases and Castration-Resistant Prostate Cancer

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

location_facility:
Chu Grenoble
IPC Marseille
APHP Hopital Cochin
ONCOLOPE
Icm Val D'Aurelle
UP Clermont Ferrand
ICO Bordeaux
CRLC de Nantes


title: Phase II Study to Assess Preoperative Hypofractionated Stereotactic Radiotherapy of Brain Metastases

acronym: STEP

summary: STEP is a French multicentre, prospective, non-randomized, phase II study designed to assess 6-months local control after pre-operative stereotactic radiosurgery (SRS) for patients with brain metastases

ReferenceCitation: Ginzac A, Dupic G, Brun L, Molnar I, Casile M, Durando X, Verrelle P, Lemaire JJ, Khalil T, Biau J. Preoperative stereotactic radiosurgery for brain metastases: the STEP study protocol for a multicentre, prospective, phase-II trial. BMC Cancer. 2021 Jul 28;21(1):864. doi: 10.1186/s12885-021-08602-0.

lead_sponsor: Centre Jean Perrin

location_facility: Institut de cancérologie Strasbourg Europe (ICANS)

location_facility: Institut de cancérologie de la Loire Lucien Neuwirth


title: Characterization of a Functional Test for Mediterranean Family Fever Screening - 2

acronym: DEPIST-FMF 2

summary:
Familial Mediterranean fever (FMF) is the most common auto-inflammatory disease (prevalence: 1-5 / 10,000 inhabitants). It is caused by mutations in the MEFV gene, which encodes variants of the Pyrine inflammasome. Inflammasomes are protein complexes of the innate immunity that produce pro-inflammatory cytokines (interleukin-1β).

In vitro, our preliminary results demonstrated that the activation of the inflammatory pyrine (measured by the concentration of interleukin-1β) by kinase inhibitors is significantly increased in FMF patients compared to healthy subjects. Furthermore, a measurement of cell death gave significant results in differentiating the patients from the controls.

The performance of this functional has been tested, fast and simple diagnostic test on common mutations and wish to assess its characteristics for MEFV mutations.

The investigators hypothesize that this quick and simple functional test can serve as a diagnostic tool for FMF and can quantitatively discriminate against patients with different mutations (genotypes).

lead_sponsor: Hospices Civils de Lyon

location_facility: Service de Pédiatrie - CHU de Nîmes - Hôpital Carémeau

intervention_type: Biological


title: Interest of Denosumab Treatment in Osteoporosis Associated to Systemic Mastocytosis

acronym: DenosuMast

summary:
The study is looking at the efficacy of subcutaneously administrated denosumab 60 mg every 6 months versus placebo after 3 years, by analyze of lumbar spine bone mineral density (BMD) in systemic mastocytosis.

Investigators hypothesize that use of denosumab subcutaneously in patients with osteoporosis related to systemic mastocytosis is effective and safe to improve bone mineral density and prevent new bone events, based on targeted specific RANKL secretion by mast cells and short half-life of denosumab.

ReferenceCitation: Johnson MR, Verstovsek S, Jorgensen JL, Manshouri T, Luthra R, Jones DM, Bueso-Ramos CE, Medeiros LJ, Huh YO. Utility of the World Heath Organization classification criteria for the diagnosis of systemic mastocytosis in bone marrow. Mod Pathol. 2009 Jan;22(1):50-7. doi: 10.1038/modpathol.2008.141. Epub 2008 Sep 19.

ReferenceCitation: Theoharides TC, Valent P, Akin C. Mast Cells, Mastocytosis, and Related Disorders. N Engl J Med. 2015 Jul 9;373(2):163-72. doi: 10.1056/NEJMra1409760. Review.

ReferenceCitation: Frenzel L, Hermine O. Mast cells and inflammation. Joint Bone Spine. 2013 Mar;80(2):141-5. doi: 10.1016/j.jbspin.2012.08.013. Epub 2012 Oct 30. Review.

ReferenceCitation: Rabenhorst A, Christopeit B, Leja S, Gerbaulet A, Kleiner S, Förster A, Raap U, Wickenhauser C, Hartmann K. Serum levels of bone cytokines are increased in indolent systemic mastocytosis associated with osteopenia or osteoporosis. J Allergy Clin Immunol. 2013 Nov;132(5):1234-1237.e7. doi: 10.1016/j.jaci.2013.06.019. Epub 2013 Jul 31.

ReferenceCitation: Barete S, Assous N, de Gennes C, Grandpeix C, Feger F, Palmerini F, Dubreuil P, Arock M, Roux C, Launay JM, Fraitag S, Canioni D, Billemont B, Suarez F, Lanternier F, Lortholary O, Hermine O, Francès C. Systemic mastocytosis and bone involvement in a cohort of 75 patients. Ann Rheum Dis. 2010 Oct;69(10):1838-41. doi: 10.1136/ard.2009.124511. Epub 2010 Jun 22.

ReferenceCitation: van der Veer E, Arends S, van der Hoek S, Versluijs JB, de Monchy JGR, Oude Elberink JNG, van Doormaal JJ. Predictors of new fragility fractures after diagnosis of indolent systemic mastocytosis. J Allergy Clin Immunol. 2014 Dec;134(6):1413-1421. doi: 10.1016/j.jaci.2014.05.003. Epub 2014 Jun 27.

ReferenceCitation: Rossini M, Zanotti R, Viapiana O, Tripi G, Idolazzi L, Biondan M, Orsolini G, Bonadonna P, Adami S, Gatti D. Zoledronic acid in osteoporosis secondary to mastocytosis. Am J Med. 2014 Nov;127(11):1127.e1-1127.e4. doi: 10.1016/j.amjmed.2014.06.015. Epub 2014 Jun 20.

ReferenceCitation: Edwards BJ, Bunta AD, Lane J, Odvina C, Rao DS, Raisch DW, McKoy JM, Omar I, Belknap SM, Garg V, Hahr AJ, Samaras AT, Fisher MJ, West DP, Langman CB, Stern PH. Bisphosphonates and nonhealing femoral fractures: analysis of the FDA Adverse Event Reporting System (FAERS) and international safety efforts: a systematic review from the Research on Adverse Drug Events And Reports (RADAR) project. J Bone Joint Surg Am. 2013 Feb 20;95(4):297-307. doi: 10.2106/JBJS.K.01181. Review.

ReferenceCitation: Cummings SR, San Martin J, McClung MR, Siris ES, Eastell R, Reid IR, Delmas P, Zoog HB, Austin M, Wang A, Kutilek S, Adami S, Zanchetta J, Libanati C, Siddhanti S, Christiansen C; FREEDOM Trial. Denosumab for prevention of fractures in postmenopausal women with osteoporosis. N Engl J Med. 2009 Aug 20;361(8):756-65. doi: 10.1056/NEJMoa0809493. Epub 2009 Aug 11. Erratum in: N Engl J Med. 2009 Nov 5;361(19):1914.

location_facility: Toulouse Hospital, Dermatology department

location_facility: Jean Minjoz Hospital, Dermatology department

location_facility: Caen Hospital, Clinical haematology department

location_facility: Estaing Hospital, Cellular therapy and clinical haematology department

location_facility: Strasbourg Hospital, Rheumatology department

location_facility: La Pitié-Salpêtrière Hospital, Internal medicine and clinical immunology department

location_facility: Lille CHRU Hospital, Internal medicine and clinical immunology department

location_facility: Necker Hospital, Adult haematology department

location_facility: Lapeyronie Hospital, Rheumatology and Immunology department

location_facility: Cochin Hospital, Rheumatology department

location_facility: La Timone Hospital, Dermatology and cutaneous oncology department


ReferenceType: derived

ReferenceCitation: Saint A, Van Obberghen-Schilling E. The role of the tumor matrix environment in progression of head and neck cancer. Curr Opin Oncol. 2021 May 1;33(3):168-174. doi: 10.1097/CCO.0000000000000730. Review.

family: Saint

full_name: Angélique Saint

given: Angélique

family: Van Obberghen-Schilling

full_name: Ellen Van Obberghen-Schilling

given: Ellen

journal_name: Current Opinion in Oncology

publisher: Ovid Technologies (Wolters Kluwer Health)

publisher_dissemination: Wolters Kluwer Health

publisher_group: Wolters Kluwer Health

publisher_normalized: Wolters Kluwer Health

ipd_sharing_description: Individual Participant Data will not be shared at an individual level. Those data will be part of the study database including all enrolled patients.

acronym: ICING

location_facility:
Centre Antoine Lacassagne
Centre Léon Bérard
Institut de cancérologie de Lorraine
CHU de Bordeaux
Institut Claudius Régaud
CHU La Timone
Gustave Roussy Cancer Campus
Institut Curie

title: A Phase II Trial Assessing Bintrafusp Alfa, a Bifunctional Fusion Protein Targeting TGF-β and PD-L1, in a Pre-operative Setting for Resectable and Untreated Head and Neck Squamous Cell Carcinoma

summary:
This study is a prospective open label, multicenter, phase II, window-of-opportunity preoperative, single-agent trial.

This study aims to evaluate the efficacy, the safety and tolerability profile of bintrafusp alfa in patients with histologically or cytologically confirmed squamous cell carcinoma of the oral cavity, oropharynx, larynx or hypopharynx, previously untreated, with indication of primary surgery. Patients with a diagnosis of head and neck squamous cell carcinoma (HNSCC) from unknown primary will not be enrolled.


title: Drug Management of Juvenile Idiopathic Arthritis in Covid-19 Context

acronym: RHUMAJICOVID

summary: The current situation of Sars-Cov-2 pandemic generates fears in the general population. Among patients receiving long-term immunomodulatory drugs, especially in the context of auto-immune diseases, there may be legitimates interrogations about the appropriateness of continuing treatment, without modification, in the current context. Juvenile Idiopathic Arthritis is concerns by these fears (the patient and their parents). Patients are treated by several classes of immunomodulatory drugs, including non-steroidal anti-inflammatory drugs, corticosteroids and disease modifying anti-rheumatic drugs. The present study will characterize this issue by defining the proportion of patients whose usual treatment of Juvenile Idiopathic Arthritis has been modified in relation to the actual sanitary crisis, and also to return to school.

lead_sponsor: University Hospital, Brest

location_facility:
CH de Belfort
CHU de Strasbourg
CHU de Bordeaux
AP-HP Hôpital Kremlin-Bicêtre
CHU de Nancy
CHU de Poitiers
CHRU de Brest
CHU de Rennes


title: TROPHAMET, a Phase I/II Trial of Avelumab and METhotrexate in Low-risk Gestational TROPHoblastic Neoplasias as First Line Treatment

acronym: TROPHAMET

summary:
Gestational trophoblastic neoplasias (GTN) are characterized by the persistence of elevated hCG titers after complete uterine evacuation of a partial hydatidiform mole (PHM) or a complete hydatidiform mole.

Low-risk GTN patients (FIGO score ≤ 6) are commonly treated with single agent treatment (methotrexate or actinomycin-D) The cure rate, assessed by hCG normalization, is obtained in 65 to 75% of patients with these agents GTN patients with resistance to these treatments are treated with another single agent drug or polychemotherapy regimens, such as EMA-CO or BEP regimen.

Chemotherapy standard regimens are old and toxic for these young lady patients, with potential long term effects detrimental for further maternity and quality of life

There is a strong rational for investigating the anti-PDL1 monoclonal antibody avelumab in chemoresistant GTN patients. Several elements suggest that the normal pregnancy immune tolerance is "hijacked" by GTN cell for proliferating :

Spontaneous regressions of metastastic GTN are regularly observed, thereby the role of immune system for rejecting GTN cells.
Strong and constant overexpression of PDL1 and NK cells has been found in all subtypes and settings of GTN tumors from French reference gestational trophoblastic center.
Complete and durable responses to pembrolizumab were reported in 3 patients with multi-chemoresistant GTN in United Kingdom.
Three cases of hCG normalization with avelumab in 6 patients with chemo-resistant GTN enrolled in TROPHIMMUN cohort A (resistant to a mono-chemotherapy).
Cytotoxicity of avelumab is mediated through antibody dependent cell cytotoxicity (ADCC) by NK cells.

location_facility:
Centre Eugène Marquis
Centre Antoine Lacassagne
Centre François Baclesse
Assistance Publique Hôpitaux de Paris
Centre Oscar Lambret
Institut Paoli-Calmettes
Centre Hospitalier Lyon Sud
Institut Bergonié


acronym: PREP-COVID

location_facility:
Hôpital Necker
Hôpital Saint Antoine
Hopial Avicenne
Hôpital européen Georges Pompidou
Hôpital La Pitié-Salpétrière
Hôpital Cochin
Hôpital Broca
Hôpital GHU Paris Saclay

title: Randomized Multicenter Study Evaluating the Efficacy of Azithromycin and Hydroxychloroquine in the Prevention of SARS-CoV-2 Infection in the Hospital Population Exposed to Virus

summary: The Investigators propose to set up a preventive trial of infection in hospital workers at risk of coronavirus infection by comparing the rate of SARS-Cov-2 infection in a population of negative SARS-Cov-2 hospital workers receiving preventively azithromycin, hydroxychloroquine or a Placebo


title: Comparison of an Inhaled Sedation Strategy to an Intravenous Sedation Strategy in Intensive Care Unit Patients Treated With Invasive Mechanical Ventilation : INASED Study

acronym: INASED

summary: The objective of the study is to determine the impact on the frequency of occurrence of delirium of an early inhaled sedation strategy (from induction in rapid sequence if intubation in intensive care, or from admission if intubated in pre -hospital) by Isoflurane using an ANACONDA ™ type system, compared to a conventional intravenous sedation strategy.

ReferenceCitation: Bailly P, Egreteau PY, Ehrmann S, Thille AW, Guitton C, Grillet G, Reizine F, Huet O, Jaber S, Nowak E, L'her E. Inased (inhaled sedation in ICU) trial protocol: a multicentre randomised open-label trial. BMJ Open. 2021 Feb 19;11(2):e042284. doi: 10.1136/bmjopen-2020-042284.

family: Bailly

full_name: Pierre Bailly

given: Pierre

family: Egreteau

full_name: Pierre-Yves Egreteau

given: Pierre-Yves

family: Ehrmann

full_name: Stephan Ehrmann

given: Stephan

family: Thille

full_name: Arnaud W Thille

given: Arnaud W

family: Guitton

full_name: Christophe Guitton

given: Christophe

family: Grillet

full_name: Guillaume Grillet

given: Guillaume

family: Reizine

full_name: Florian Reizine

given: Florian

family: Huet

full_name: Olivier Huet

given: Olivier

family: Jaber

full_name: S Jaber

given: S

family: Nowak

full_name: Emmanuel Nowak

given: Emmanuel

family: L'her

full_name: Erwan L'her

given: Erwan

currency_apc_doaj: GBP

journal_name: BMJ Open

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Université de Bretagne Occidentale

repository_normalized: HAL

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

repositories:
HAL
PubMed Central

publisher: BMJ

publisher_dissemination: British Medical Journal

publisher_group: British Medical Journal

publisher_normalized: British Medical Journal

ipd_sharing_description: All collected data that underlie results in a publication

location_facility:
GHBS Lorient
CH Le Mans
CHU Poitiers
CH Morlaix
CHU Montpellier
CHU Tours
CHU de Brest
CHU Rennes


title: Cardiovascular Complications in Patients With COVID-19

acronym: CovCardioVasc

summary: Patients with COVID-19 in the Intensive Care Unit (ICU) or hospitalized with severe form have a poor prognosis (almost 30% rate of death). They present often a high cardiovascular risk profile (almost 30% of hypertension and 19% of diabetes). Troponin has been described to be elevated in a high proportion of patients (one fifth of all patients and 50% of non-survivors) suggesting the possibility of cardiomyopathies. High levels of DDimers (81% of non survivors) and fibrin degradation products are also associated with increased risk of mortality suggesting also the possibility of venous thromboembolism. Therefore, screening for cardiomyopathies and venous thromboembolism could represent an important challenge for patients with COVID-19 management.

ReferenceCitation: Ferrari E, Sartre B, Squara F, Contenti J, Occelli C, Lemoel F, Levraut J, Doyen D, Dellamonica J, Mondain V, Chirio D, Risso K, Cua E, Orban JC, Ichai C, Labbaoui M, Mossaz B, Moceri P, Appert-Flory A, Fischer F, Toulon P. High Prevalence of Acquired Thrombophilia Without Prognosis Value in Patients With Coronavirus Disease 2019. J Am Heart Assoc. 2020 Nov 3;9(21):e017773. doi: 10.1161/JAHA.120.017773. Epub 2020 Sep 25.

name: Department of Cardiology University Hospital of Nice France

family: Ferrari

full_name: Emile Ferrari

given: Emile

family: Sartre

full_name: Benjamin Sartre

given: Benjamin

family: Squara

full_name: Fabien Squara

given: Fabien

name: Department of Emergency University Hospital of Nice France

family: Contenti

full_name: Julie Contenti

given: Julie

family: Occelli

full_name: Celine Occelli

given: Celine

family: Lemoel

full_name: Fabien Lemoel

family: Levraut

full_name: Jacques Levraut

given: Jacques

name: Department of Intensive Care 1 University Hospital of Nice France

family: Doyen

full_name: Denis Doyen

given: Denis

family: Dellamonica

full_name: Jean Dellamonica

given: Jean

name: Department of Infectious Diseases University Hospital of Nice France

family: Mondain

full_name: Veronique Mondain

given: Veronique

family: Chirio

full_name: David Chirio

given: David

family: Risso

full_name: Karine Risso

given: Karine

family: Cua

full_name: Eric Cua

given: Eric

name: Department of Intensive Care 2 University Hospital of Nice France

family: Orban

full_name: Jean Christophe Orban

given: Jean Christophe

family: Ichai

full_name: Carole Ichai

given: Carole

family: Labbaoui

full_name: Mohamed Labbaoui

given: Mohamed

family: Mossaz

full_name: Baptiste Mossaz

given: Baptiste

family: Moceri

full_name: Pamela Moceri

given: Pamela

name: Hematology Laboratory University Hospital of Nice France

family: Appert‐Flory

full_name: Anny Appert‐Flory

given: Anny

family: Fischer

full_name: Florence Fischer

given: Florence

family: Toulon

full_name: Pierre Toulon

journal_name: Journal of the American Heart Association

ipd_sharing_description: no data sharing plan has been established.

lead_sponsor: Centre Hospitalier Universitaire de Nice

location_facility: Hôpitaux Universitaires Paris Centre - Hôpital Cochin


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

acronym: CORIMUNO-TOC

summary: The overall objective of the study is to determine the therapeutic effect and tolerance of Tocizilumab in patients with moderate, severe pneumonia or critical pneumonia associated with Coronavirus disease 2019 (COVID-19). Tocilizumab (TCZ) is an anti-human IL-6 receptor monoclonal antibody that inhibits signal transduction by binding sIL-6R and mIL-6R. The study has a cohort multiple Randomized Controlled Trials (cmRCT) design. Randomization will occur prior to offering Tocilizumab administration to patients enrolled in the COVIMUNO-19 cohort. Tocilizumab will be administered to consenting adult patients hospitalized with CORVID-19 either diagnosed with moderate or severe pneumonia requiring no mechanical ventilation or critical pneumonia requiring mechanical ventilation. Patients who will chose not to receive Tocilizumab will receive standard of cares. Outcomes of Tocilizumab-treated patients will be compared with outcomes of standard of care treated patients as well as outcomes of patients treated with other immune modulators.

ReferenceCitation: Tleyjeh IM. The Misleading "Pooled Effect Estimate" of Crude Data from Observational Studies at Critical Risk of Bias: The Case of Tocilizumab in Coronavirus Disease 2019 (COVID-19). Clin Infect Dis. 2021 Jun 15;72(12):e1154-e1155. doi: 10.1093/cid/ciaa1735.

name: Infectious Diseases Section, Department of Medical Specialties, King Fahad Medical City, Riyadh, Saudi Arabia

name: Division of Infectious Diseases, Mayo Clinic College of Medicine and Science, Rochester, Minnesota, USA

name: Division of Epidemiology, Mayo Clinic College of Medicine and Science, Rochester, Minnesota, USA

name: College of Medicine, Alfaisal University, Riyadh, Saudi Arabia

family: Tleyjeh

full_name: Imad M Tleyjeh

given: Imad M

journal_name: Clinical Infectious Diseases

evidence: open (via free article)

publisher: Oxford University Press (OUP)

publisher_dissemination: Oxford University Press

publisher_group: Oxford University Press

publisher_normalized: Oxford University Press

title: The Misleading “Pooled Effect Estimate” of Crude Data from Observational Studies at Critical Risk of Bias: The Case of Tocilizumab in Coronavirus Disease 2019 (COVID-19)

ReferenceCitation: Hermine O, Mariette X, Tharaux PL, Resche-Rigon M, Porcher R, Ravaud P; CORIMUNO-19 Collaborative Group. Effect of Tocilizumab vs Usual Care in Adults Hospitalized With COVID-19 and Moderate or Severe Pneumonia: A Randomized Clinical Trial. JAMA Intern Med. 2021 Jan 1;181(1):32-40. doi: 10.1001/jamainternmed.2020.6820. Erratum in: JAMA Intern Med. 2021 Jan 1;181(1):144. Erratum in: JAMA Intern Med. 2021 Jul 1;181(7):1021.

name: Department of Hematology, Hôpital Necker, Assistance Publique - Hôpitaux de Paris, France

name: Institut Imagine, Université de Paris, INSERM UMR1183, Paris France

family: Hermine

full_name: Olivier Hermine

given: Olivier

name: Department of Rheumatology, Hôpital Bicêtre, Assistance Publique-Hôpitaux de Paris, France

name: Université Paris-Saclay, INSERM UMR1184, Le Kremlin Bicêtre, France

family: Mariette

full_name: Xavier Mariette

given: Xavier

name: Paris Cardiovascular Center–PARCC, Université de Paris, INSERM, F-75015 Paris, France

family: Tharaux

full_name: Pierre-Louis Tharaux

given: Pierre-Louis

name: Université de Paris, ECSTRRA Team-CRESS-UMR 1153, INSERM, 75010, Paris, France

name: URC Saint-Louis, AP-HP, Hôpital Saint-Louis, 75010, France

family: Resche-Rigon

full_name: Matthieu Resche-Rigon

given: Matthieu

name: Université de Paris, Centre of Research Epidemiology and Statistics (CRESS), INSERM U1153, Paris, France

family: Porcher

full_name: Raphaël Porcher

given: Raphaël

name: Centre d’Epidémiologie Clinique, AP-HP (Assistance Publique des Hôpitaux de Paris), Hôpital Hôtel Dieu, Paris, France

family: Ravaud

full_name: Philippe Ravaud

given: Philippe

family: Bureau

full_name: Serge Bureau

given: Serge

family: Dougados

full_name: Maxime Dougados

given: Maxime

family: Tibi

full_name: Annick Tibi

given: Annick

family: Azoulay

full_name: Elie Azoulay

given: Elie

family: Cadranel

full_name: Jacques Cadranel

family: Emmerich

full_name: Joseph Emmerich

given: Joseph

family: Fartoukh

full_name: Muriel Fartoukh

given: Muriel

family: Guidet

full_name: Bertrand Guidet

given: Bertrand

family: Humbert

full_name: Marc Humbert

given: Marc

family: Lacombe

full_name: Karine Lacombe

family: Mahevas

full_name: Matthieu Mahevas

location_facility:
APHP - Pitié Salpêtrière
APHP - Hopital Necker
APHP- Hopital Tenon
CHU Strasbourg
APHP - Bichat
APHP - Beaujon
APHP - Saint Louis
Institut Gustave Roussy


title: Precision Medicine Phase II Study Evaluating the Efficacy of a Double Immunotherapy by Durvalumab and Tremelimumab Combined With Olaparib in Patients With Solid Cancers and Carriers of Homologous Recombination Repair Genes Mutation in Response or Stable After Olaparib Treatment

summary: The study propose to generate a clinical trial based on precision medicine to evaluate the use of immunotherapy in patients with altered homologous recombination repair genes and without progression after prior targeted therapy.

ReferenceCitation: Fumet JD, Limagne E, Thibaudin M, Truntzer C, Bertaut A, Rederstorff E, Ghiringhelli F. Precision medicine phase II study evaluating the efficacy of a double immunotherapy by durvalumab and tremelimumab combined with olaparib in patients with solid cancers and carriers of homologous recombination repair genes mutation in response or stable after olaparib treatment. BMC Cancer. 2020 Aug 10;20(1):748. doi: 10.1186/s12885-020-07253-x.

family: Fumet

full_name: Jean-David Fumet

given: Jean-David

family: Limagne

full_name: Emeric Limagne

given: Emeric

family: Thibaudin

full_name: Marion Thibaudin

given: Marion

family: Truntzer

full_name: Caroline Truntzer

given: Caroline

family: Bertaut

full_name: Aurélie Bertaut

given: Aurélie

family: Rederstorff

full_name: Emilie Rederstorff

given: Emilie

family: Ghiringhelli

full_name: Francois Ghiringhelli

given: Francois

journal_name: BMC Cancer

license: cc-by

license_normalized: cc-by

publisher: Springer Science and Business Media LLC

publisher_dissemination: Springer-Nature

publisher_group: Springer-Nature

publisher_normalized: Springer

lead_sponsor: Centre Georges Francois Leclerc

location_facility:
Centre Oscar Lambret
CHRU Jean Minjoz
Centre Georges François Leclerc
Institut Hospitalier Franco-Britannique
CHU François Mitterrand
Centre Leon Berard
Institut Bergonié
CHU Amiens


title: Aspirin for Uncontrolled Asthma : a Randomized Controlled Study

acronym: ASTHMIRINE

summary:
Asthma is characterized by changes in eicosanoids metabolism, especially high production of bronchoconstrictive cysteinyl leukotrienes (CystLTBs) and leukotriene B4 (LTB4). Recent studies have also demonstrated a relative low production of lipoxin A4, an endogenous lipid mediator resulting from lipo-oxygenase action, distinct from CystLTBs, with anti-inflammatory properties, in bronchial epithelial cells and lung macrophages of severe asthma patients, leading to imbalance between pro-resolving and pro-inflammatory eicosanoids production in airways. Such data suggest that aspirin, that induces lipoxins production, could restore lipoxins deficit in severe asthma. Interest for aspirin is also supported by data obtained in asthma patients with aspirin intolerance (Aspirin induced asthma, AIA) : in this particular group of patients, aspirin treatment significantly improves nasal symptoms, quality of life, asthma and rhinitis scores, and reduces need for hospitalizations, nasal surgery and oral steroids use. Potential effect of aspirin in patients with uncontrolled asthma without aspirin intolerance, who presented changes in arachidonic acid pathway close to those observed in AIA, is not established.

The aim of the study is to assess whether long term aspirin treatment could improve asthma control, compared to placebo, in patients with uncontrolled disease and nasal polyposis, whatever their aspirin tolerance level.

ipd_sharing: Undecided

lead_sponsor: Assistance Publique - Hôpitaux de Paris

location_facility: Service de Pneumologie - La Croix Rousse

location_facility: Service de Pneumologie - Hôpital François Mitterrand - CHU Dijon

location_facility: Service de pneumologie - Hôpital Charles Nicolle - CHU Rouen

location_facility: Service de pneumologie - Nouvel Hopital Civil - CHU strasbourg

location_facility: Service de Pneumologie - Hôpital Bicêtre

location_facility: Clinique des bronches, de l'allergie et du sommeil Hôpital Nord

location_facility: Service de pneumologie - Hôpital Calmette - CHRU Lille


title: Multicentre Double-blind Randomized Clinical Trial Assessing Efficacy and Safety of Exenatide in the Treatment of Hypothalamic Obesity After Craniopharyngioma Therapy

acronym: CRANIOEXE

summary:
This hypothalamic obesity is associated with serious metabolic and psychosocial consequences.

The purpose of the study is to compare the change of body weight after 6 months treatment with a lifestyle intervention + exenatide compare to the one after the same lifestyle intervention+ placebo in adults patients suffering from a hypothalamic obesity due to treatment of craniopharyngioma.

location_facility:
APHM
Hôpital Pitié Salpétrière (APHP)
CHU d'Angers
CHU de Grenoble
Hôpital Cochin
CHU de Lyon
Hôpital Européen Georges Pompidou
CHU de Brest
Hôpital Bicêtre
CHU de Toulouse
Hôpital Haut-Lévêque


title: Predictive Tracking of Patient Flow in the Emergency Services During the Virus Winter Epidemics

acronym: PREDAFLU

summary:
Epidemics and infectious diseases in general, punctuate much of the activity of an emergency service. The impact of winter infections is particularly important to vulnerable populations such as infant during bronchiolitis epidemics and the elderly during seasonal influenza. Each year, these epidemic phenomena lead to disorganization of emergency services and healthcare teams by lack of anticipation and organizational measures in particular to manage the approval of emergency services for the most vulnerable populations requiring hospitalization.

For 2 years, the pediatric emergency department of St Etienne University Hospital has a decision support tool for the periods of winter epidemics. Through a retrospective analysis of Passages of Emergency summary, this tool provides an estimate of infants with bronchiolitis flow day to day, and the availability in real time of an abnormally high flow of patients to pediatric emergencies. These data can help to affirm that the epidemic begins in this hospital.

lead_sponsor: Centre Hospitalier Universitaire de Saint Etienne

location_facility: CHU de Saint Etienne (adult emergency service)

location_facility: CHU de Saint Etienne (Pediatric service)

location_facility: CHU de Grenoble (adult emergency service)

location_facility: CH de Villefranche (adult emergency service)


title: Randomized Phase II Study Assessing the Efficacy and Safety of 2 Therapeutic Strategies Combining Bevacizumab With Chemotherapy: De-escalation Versus Escalation in Patients With Non-pretreated Unresectable Metastatic Colorectal Cancer

acronym: HIGH-LIGHT

summary:
The intensity of tumour response appears to be correlated with the feasibility and the duration of a therapeutic pause or of a reduced maintenance therapy maintained until progression in patients initially controlled by so-called "induction" chemotherapy. Bevacizumab combined with cytotoxic chemotherapy (5-FU, irinotecan and/or oxaliplatin) has shown that it is possible to improve the tumour response rate and patient prognosis in 1st and 2nd lines. With a very favourable safety profile , it is an excellent candidate as induction treatment and also as maintenance treatment. Prospective data from recent trials have actually demonstrated improvement in PFS and/or overall survival with bevacizumab maintenance alone or in combination with 5FU (or capecitabine) after induction chemotherapy (FOLFIRI or FOLFOX + bevacizumab).

At the same time, the maintenance of anti-angiogenic pressure after progression in 1st line metastatic has demonstrated its benefit in terms of PFS and overall survival. Bevacizumab maintenance in 2nd line metastatic, despite progression, thus appears to be a valid strategy.

lead_sponsor: Federation Francophone de Cancerologie Digestive

location_facility: Chu Robert Debre - Medecine Ambulatoire-Cancerologie

location_facility: Centre Hospitalier de St Malo - Service Hepato-Gastro-Enterologie

location_facility: Ch de Cholet - Service Maladies de L4Appareil Digestif Du Dr Kaasis

location_facility: Hopital Pierre Oudot - Service de Gastroenterologie

location_facility: Chu de Saint Etienne-Hopital Nord - Service Hge

location_facility: Hopital Prive Saint Gregoire - Service de Radiotherapie


title: Can Nephrocheck™ Predict the Reversibility of Early, Acute Kidney Injury During Septic Shock?

acronym: AKI-CHECK

summary: Patients with septic shock in the intensive care unit have an elevated risk of developing acute kidney injury (AKI).

status: Unknown status

ReferenceCitation: Titeca-Beauport D, Daubin D, Van Vong L, Belliard G, Bruel C, Alaya S, Chaoui K, Andrieu M, Rouquette-Vincenti I, Godde F, Pascal M, Diouf M, Vinsonneau C, Klouche K, Maizel J. Urine cell cycle arrest biomarkers distinguish poorly between transient and persistent AKI in early septic shock: a prospective, multicenter study. Crit Care. 2020 Jun 1;24(1):280. doi: 10.1186/s13054-020-02984-6. Erratum in: Crit Care. 2020 Aug 4;24(1):483.

family: Titeca-Beauport

full_name: Dimitri Titeca-Beauport

given: Dimitri

family: Daubin

full_name: Delphine Daubin

given: Delphine

family: Van Vong

full_name: Ly Van Vong

given: Ly

family: Belliard

full_name: Guillaume Belliard

given: Guillaume

family: Bruel

full_name: Cédric Bruel

given: Cédric

family: Alaya

full_name: Sami Alaya

given: Sami

family: Chaoui

full_name: Karim Chaoui

given: Karim

family: Andrieu

full_name: Maud Andrieu

given: Maud

family: Rouquette-Vincenti

full_name: Isabelle Rouquette-Vincenti

given: Isabelle

family: Godde

full_name: Frederic Godde

given: Frederic

family: Pascal

full_name: Michel Pascal

given: Michel

family: Diouf

full_name: Momar Diouf

given: Momar

family: Vinsonneau

full_name: Christophe Vinsonneau

given: Christophe

family: Klouche

full_name: Kada Klouche

given: Kada

family: Maizel

full_name: Julien Maizel

given: Julien

journal_name: Critical Care

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

lead_sponsor: Centre Hospitalier Universitaire, Amiens

location_facility:
CH Dax
CH Cahors
CHU Poitiers
CH Avranches-Granville
CHU Montpellier
CH Paris-Saint Joseph
CH Marc Jacquet
CHU Saint-Etienne
CH de Mont-de-Marsan
CH Salon-de-provence
CHU Amiens


title: Case-control Study of the Influence of Pesticide Exposure on the Occurrence of Hypospadias in Newborns in Picardie

acronym: HYPOMECO

summary: We want to see if there is a relationship between exposure to pesticides and the occurrence of hypospade in Picard newborn .

ReferenceCitation: Haraux E, Tourneux P, Kouakam C, Stephan-Blanchard E, Boudailliez B, Leke A, Klein C, Chardon K. Isolated hypospadias: The impact of prenatal exposure to pesticides, as determined by meconium analysis. Environ Int. 2018 Oct;119:20-25. doi: 10.1016/j.envint.2018.06.002. Epub 2018 Jun 18.

family: Haraux

full_name: Elodie Haraux

given: Elodie

family: Tourneux

full_name: Pierre Tourneux

given: Pierre

family: Kouakam

full_name: Christelle Kouakam

given: Christelle

family: Stephan-Blanchard

full_name: Erwan Stephan-Blanchard

given: Erwan

family: Boudailliez

full_name: Bernard Boudailliez

given: Bernard

family: Leke

full_name: Andre Leke

given: Andre

family: Klein

full_name: Celine Klein

given: Celine

family: Chardon

full_name: Karen Chardon

given: Karen

journal_name: Environment International

publisher: Elsevier BV

publisher_dissemination: Elsevier

publisher_group: Elsevier

publisher_normalized: Elsevier

location_facility:
CH Chateau Thierry
CH Péronne
CH Creil
CH Chauny
Groupe Santé Victor Pauchet
CH Senlis
CH Abbeville
CH Saint Quentin
CH Compiegne
CHU Amiens
CH Laon


title: Medical Economic Evaluation of Bilateral Allograft of Hands and Forearms

acronym: ARMEDIC

summary:
The double amputation of the forearms is a rare handicap that seriously impacts the autonomy and the quality of life of patients, social and familial exclusion, and dependence on third parties for everyday activities.

The management of these patients is nearly exclusively through the use of prostheses. Certain patients refuse this solution, or remain penalized by the absence of sensitivity , the lack of precision in movements, and body image issues related to the amputation; the double graft of hands and forearms may, in this circumstance, be the only solution.

Since January 2000, date of the first double hand graft, six bilateral grafts of hands have been performed at the Hospices Civils de Lyon. This first study reported the feasibility of the graft. The functional results obtained after the double transplant have allowed patients to recover complete autonomy for everyday activities, at the price of an immunosuppressive treatment. We have found that these very good functional results are maintained over time and, for a certain number of patients, to return to work which is a factor of social integration.

The rate of medical complications (metabolic, infectious, oncological), essentially related to the immunosuppressive treatment, is not greater to that found for other types of graft, but are considered as a limiting factor for the development of this strategy. These results are confirmed by international experience that is of the same order. Only a few rare cases of re-amputation have been reported in patients for whom the immunosuppressive treatment was discontinued or following vascular thrombosis.

A new study is required to continue this evaluation and to compare double graft to prostheses in terms costs, quality of life, usefulness, satisfaction, autonomy, and social integration. The results of this study will allow the placement of these strategies in the management of patients with double amputation of the hands and forearms.

location_facility: Service de Médecine Physique et Réadaptation - Institut Régional de Médecine Physique et de Réadaptation

location_facility: Serice de Rééducation et Réadaptation fonctionnelles - Hôpital Henry-Gabrielle - Hospices Civils de Lyon

location_facility: Serice de Médecine Physique et Réadaptation - Hôpital d'Instruction des Armées Percy

location_facility: Service de Médecine Physique et Réadapatation fonctionnelle - Centre de Médecine Physique et de Réadaptation La Tour de Gassies

location_facility: Serice de Rééducation et Réadaptation fonctionnelles - Centre l'Espoir

location_facility: Serice de Médecine Physique et Réadaptation des patients amputés - Centre Médico-Chirugical et de Réadaptation des Massues

location_facility: Service de Chirurgie de la Transplantation - Hôpital Edouard Herriot - Hospices Civils de Lyon

location_facility: Serice de Rééducation et Réadaptation fonctionnelles - Centre Médical de Rééducation Romans Ferrari

location_facility: Serice de Rééducation fonctionnelle - Centre Mutualiste de Rééducation et Réadaptation fonctionnelles de Kerpape

location_facility: Serice de Rééducation et Réadaptation fonctionnelles - Centre Jacques Calvé - Fondation Hopale

location_facility: Service de Rééducation et appareillage - Institut Robert Merle d'Aubigné


title: Multicenter Prospective Study Comparing KRAS, NRAS and BRAF Mutation Testing Using OncoBEAM Technique in Plasma vs Conventional Techniques in Formalin Fixed Paraffin Embedded Tissues

acronym: ColoBEAM

summary: RAS genotyping is mandatory for the prescription of anti-EGFR (epidermal growth factor receptor) therapies in patients with metastatic colorectal cancer. The standard genotyping is assessed on formalin-fixed paraffin embedded tumour tissue. This study compares RAS and BRAF genotyping results achieved in analyzing circulating plasma DNA using OncoBEAM™ technique with those achieved using the standard genotyping techniques and formalin-fixed paraffin embedded samples.

primary_purpose: Diagnostic

lead_sponsor: Institut de Cancérologie de Lorraine

location_facility:
CH Chalon Sur Saône-William Morey
Polyclinique Courlancy Reims
CHRU Nancy
Polyclinique de Gentilly
CH Auxerre
Centre Georges François Leclerc Dijon
CHU Reims-Hôpital Robert Debré
Hopital Belle-Isle-Metz
Institut de Cancérologie de Lorraine
CH Besançon-Hopital Jean Minjoz
Centre Paul Stauss

intervention_type: Genetic


title: Evaluation of an Arterial Calcification Score as a Predictive Factor of Anastomotic Leakage in Right Colectomy

acronym: RIGHTCOLOCALCI

summary:
Anastomotic leakage is the major postoperative complication in right colectomy. Evaluation of calcification on coeliac trunk and mesenteric arteries on the preoperative CT scan could allow the identification of patient at-risk of postoperative complications.

A monocentric retrospective study performed at CHD Vendée concluded than a calcification score over or equal to 3 was associated with a higher risk of developping an anastomotic leakage.

The aim of this prospective multicentric study is to validate a calcification score based on preoperative CT scan analysis and focussing at coeliac trunk and mesenteric arteries.This study will involve patients operated on with a scheduled right colectomy.

lead_sponsor: Centre Hospitalier Departemental Vendee

location_facility: Clinique Mutualiste de la Porte de l'Orient


title: ANRS EP59 CLEAC : Physiopathological Study of Immunovirological Evolution of Perinatally HIV-1 Infected Children Depending on Early (Before 6 Months) or Late (After 2 Years) Antiretroviral Therapy Introduction.

acronym: CLEAC

summary:
The study aims to define and compare the immunological characteristics (lymphocyte subpopulations, specific immunity against HIV, lymphocyte activation, inflammatory parameters) and the virological characteristics (study of viral reservoir) between 2 groups of vertically-HIV-1-infected children, between 5 and 17-year-of-age, who started cART before 6 months-of-age ("early treatment" group) or after 24 months-of-age ("late treatment" group) with an initial virologic success (HIV-1 RNA <400 copies / mL reached no later than 24 months after the start of cART), whatever the later evolution of the viremia.

Moreover, the viral reservoir will be deeply characterized in 10 children (5 patients in each group) with sustained control of the HIV-1 viremia under cART (≥ 90% of HIV-1 RNA measures <400 copies /mL): quantification of the reservoir in the lymphocyte subpopulations and study of the inductibility of the viral reservoir.

primary_purpose: Basic Science

ReferenceCitation: Frange P, Montange T, Le Chenadec J, Batalie D, Fert I, Dollfus C, Faye A, Blanche S, Chacé A, Fourcade C, Hau I, Levine M, Mahlaoui N, Marcou V, Tabone MD, Veber F, Hoctin A, Wack T, Avettand-Fenoël V, Warszawski J, Buseyne F. Impact of Early Versus Late Antiretroviral Treatment Initiation on Naive T Lymphocytes in HIV-1-Infected Children and Adolescents - The-ANRS-EP59-CLEAC Study. Front Immunol. 2021 Apr 22;12:662894. doi: 10.3389/fimmu.2021.662894. eCollection 2021.

family: Frange

full_name: Pierre Frange

family: Montange

full_name: Thomas Montange

given: Thomas

family: Le Chenadec

full_name: Jérôme Le Chenadec

given: Jérôme

family: Batalie

full_name: Damien Batalie

given: Damien

family: Fert

full_name: Ingrid Fert

given: Ingrid

family: Dollfus

full_name: Catherine Dollfus

given: Catherine

family: Faye

full_name: Albert Faye

given: Albert

family: Blanche

full_name: Stéphane Blanche

given: Stéphane

family: Chacé

full_name: Anne Chacé

given: Anne

family: Fourcade

full_name: Corine Fourcade

given: Corine

family: Hau

full_name: Isabelle Hau

family: Levine

full_name: Martine Levine

given: Martine

family: Mahlaoui

full_name: Nizar Mahlaoui

given: Nizar

family: Marcou

full_name: Valérie Marcou

given: Valérie

family: Tabone

full_name: Marie-Dominique Tabone

given: Marie-Dominique

family: Veber

full_name: Florence Veber

given: Florence

family: Hoctin

full_name: Alexandre Hoctin

given: Alexandre

family: Wack

full_name: Thierry Wack

given: Thierry

family: Avettand-Fenoël

full_name: Véronique Avettand-Fenoël

given: Véronique

family: Warszawski

full_name: Josiane Warszawski

given: Josiane

family: Buseyne

full_name: Florence Buseyne

journal_name: Frontiers in Immunology

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

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

title: Impact of Early Versus Late Antiretroviral Treatment Initiation on Naive T Lymphocytes in HIV-1-Infected Children and Adolescents – The-ANRS-EP59-CLEAC Study

location_facility: Centre Hospitalier Général- Hôpital Delafontaine


title: Impact on Anti-infectious Treatments of the Early Molecular Detection Technique Coupled With Urinary Test of Infectious Agents Responsible of Community-acquired Pneumonia of Children at Pediatric Emergencies

acronym: OptiPAC

summary:
Community-Acquired Pneumonia (CAP) of children are a recurrent pathology with multiple severity scores. The etiology is never really identified, and the initial treatment is always based on probabilistic antibiotics, in the case of an bacterial infection, and by the way, potentially severe.

Molecular tests ("multiplex") allow the simultaneous detection of a huge number of pathogenic agents, virus and bacteria, are now available.

This project is based on a new strategy of diagnostic, using a multiplex PCR with quick results, coupled to an antigenic urinary test to allow a complete, quick, etiologic diagnostic as soon as children are supported in emergency.

Children are randomized in two groups during inclusions : quick diagnostic strategy versus usual practice. Analyse will be centralized on anti-infectious treatment optimization, with the aim to better treat patients, minimize the costs, and decrease selection pressure of multi-resistant bacteria.

location_facility:
Chu Grenoble
Chu Brest
Chu Reims
Chu Marseille
CHU CAEN
Chu Strasbourg
APHP - Necker
Chu Saint Etienne
Chu Toulouse
Chu Estaing
APHP - Béclère


acronym: ROSCO-CF

location_facility: Centre de Ressources et de Compétences de la mucoviscidose

title: A Phase II, Dose Ranging, Multicenter, Double-blind, Placebo Controlled Study to Evaluate Safety and Effects of (R)-Roscovitine in Adults Subjects With Cystic Fibrosis, Carrying 2 Cystic Fibrosis Causing Mutations With at Least One F508del-CFTR Mutation and Chronically Infected With Pseudomonas Aeruginosa, a Study Involving 36 CF Patients (24 Treated, 12 Controls). ROSCO-CF.

summary:
This is a phase II, dose ranging, multicenter, randomized, double-blind, placebo-controlled study.

The aim of this study is to assess the safety of increasing doses of roscovitine administered orally for 4 cycles of 4 consecutive days (treatment "on") separated by a 3 days treatment free period (treatment "off") in adult CF subjects with Cystic Fibrosis carrying 2 Cystic Fibrosis causing mutations with at least one F508del-CFTR mutation and chronically infected with Pseudomonas aeruginosa.

This study involved 36 Cystic Fibrosis patients: 24 treated and 12 controls.


title: Multicentre, Cross-over, PRAgmatic Trial in Atopic Dermatitis Testing Long-term Control Effectiveness of New Phototherapy Regimen During Winter as an add-on Therapy, Coupled With Oral Vitamin D Supplementation vs. Placebo in a Randomised, Parallel-group Trial

acronym: PRADA

summary: Spaced phototherapy sessions during winter as add-on therapy in combination with vitamin D supplementation or not, could be beneficial to improve disease LTC in AD patients

ReferenceCitation: Droitcourt C, Barbarot S, Maruani A, Darrieux L, Misery L, Brenaut E, Adamski H, Chabbert C, Vermersch A, Weiborn M, Seneschal J, Taïeb A, Plantin P, Maillard H, Phan A, Skowron F, Viguier M, Staumont-Salle D, Nosbaum A, Soria A, Barbaud A, Oger E, Dupuy A; Groupe de Recherche sur l'Eczéma Atopique de la Société Française de Dermatologie (GREAT). A new phototherapy regimen during winter as an add-on therapy, coupled with oral vitamin D supplementation, for the long-term control of atopic dermatitis: study protocol for a multicentre, randomized, crossover, pragmatic trial - the PRADA trial. Trials. 2019 Mar 25;20(1):184. doi: 10.1186/s13063-019-3276-9.

apc_source: openAPC

family: Droitcourt

full_name: Catherine Droitcourt

name: Groupe de Recherche sur l’Eczéma Atopique de la Société Française de Dermatologie (GREAT)

family: Barbarot

full_name: Sébastien Barbarot

given: Sébastien

family: Maruani

full_name: Annabel Maruani

given: Annabel

family: Darrieux

full_name: Laure Darrieux

given: Laure

family: Misery

full_name: Laurent Misery

given: Laurent

family: Brenaut

full_name: Emilie Brenaut

given: Emilie

family: Adamski

full_name: Henri Adamski

given: Henri

family: Chabbert

full_name: Cécile Chabbert

given: Cécile

family: Vermersch

full_name: Annie Vermersch

given: Annie

family: Weiborn

full_name: Marie Weiborn

given: Marie

family: Seneschal

full_name: Julien Seneschal

given: Julien

family: Taïeb

full_name: Alain Taïeb

given: Alain

family: Plantin

full_name: Patrice Plantin

given: Patrice

family: Maillard

full_name: Hervé Maillard

given: Hervé

family: Phan

full_name: Alice Phan

given: Alice

family: Skowron

full_name: François Skowron

given: François

family: Viguier

full_name: Manuelle Viguier

given: Manuelle

family: Staumont-Salle

full_name: Delphine Staumont-Salle

given: Delphine

family: Nosbaum

full_name: Audrey Nosbaum

given: Audrey

family: Soria

full_name: Angèle Soria

given: Angèle

family: Barbaud

full_name: Annick Barbaud

given: Annick

family: Oger

full_name: Emmanuel Oger

given: Emmanuel

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Archive ouverte HAL

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Aix-Marseille Université

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

title: A new phototherapy regimen during winter as an add-on therapy, coupled with oral vitamin D supplementation, for the long-term control of atopic dermatitis: study protocol for a multicentre, randomized, crossover, pragmatic trial – the PRADA trial

location_facility:
Hôpital Laënnec
Hôpital Saint André
Centre Hospitalier
Hôpital Pontchaillou
Hôpital Morvan
Hôpital Trousseau
APHP - Hôpital Tenon
CHR St Brieuc
CHU de Nantes - Hôtel Dieu


type: Registry Identifier

title: A Phase 1/2 Open-label, Multi-center, Safety, Preliminary Efficacy and Pharmacokinetic (PK) Study of Isatuximab in Combination With Other Anti-cancer Therapies in Participants With Lymphoma

summary:
Primary Objectives:

Phase 1

-To characterize the safety and tolerability of isatuximab in combination with cemiplimab in participants with relapsed and refractory classic Hodgkin's lymphoma (cHL), diffuse large B-cell lymphoma (DLBCL) or peripheral T-cell lymphoma (PTCL), and to confirm the recommended Phase 2 dose (RP2D).

Phase 2

Cohort A1 (anti-programmed cell death protein 1/ligand 1 [PD-1/PD-L1] naïve cHL): To assess the complete remission (CR) rate of isatuximab in combination with cemiplimab.
Cohort A2 (cHL progressing from PD-1/PD-L1), B (DLBCL) and C (PTCL): To assess the objective response rate (ORR) of isatuximab in combination with cemiplimab.

Secondary Objectives:

To evaluate the safety of the RP2D of the combination of isatuximab with cemiplimab.
To evaluate the safety of the combination of isatuximab with cemiplimab and radiotherapy in patients with cHL.
To evaluate the immunogenicity of isatuximab and cemiplimab when given in combination.
To characterize the pharmacokinetic (PK) profile of isatuximab and cemiplimab when given in combination.
To assess overall efficacy of isatuximab in combination with cemiplimab and isatuximab in combination with cemiplimab and radiotherapy.

ipd_sharing_description: Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://www.clinicalstudydatarequest.com/

lead_sponsor: Sanofi

location_country:
Italy
Netherlands
Spain
France
Portugal
Korea, Republic of
Taiwan

location_facility:
Investigational Site Number :2500005
Investigational Site Number :5280001
Investigational Site Number :4100002
Investigational Site Number :2500001
Investigational Site Number :3800003
Investigational Site Number :7240004
Investigational Site Number :2500004
Investigational Site Number :7240002
Investigational Site Number :7240005
Investigational Site Number :5280002
Investigational Site Number :2500007
Investigational Site Number :7240003
Investigational Site Number :2500003
Investigational Site Number :6200002
Investigational Site Number :2500008
Investigational Site Number :1580002
Investigational Site Number :2500002
Investigational Site Number :2500006
Investigational Site Number :6200004
Investigational Site Number :6200003
Investigational Site Number :4100001
Investigational Site Number :3800006
Investigational Site Number :3800002


title: Evaluation of a Strategy Based on the 3-month Screening Biopsy to Optimize the Immunosuppression in Renal Transplantation: the I4BiS Study

summary:
Renal transplantation represents currently the best therapeutic alternative for end-stage renal failure, not only in terms of patient outcomes (better quality of life and longer survival), but also in terms of costs for the society.

Progress achieved in the last 20 years has resulted in a drastic reduction of the incidence of "classic" (i.e. clinically patent) acute cellular rejection episodes.

Unfortunately, and rather unexpectedly, this progress has had hardly any effect on the frequency of the loss of kidney transplants beyond the first year, as shown by the stagnation of grafts' half lives.

Furthermore, the use of immunosuppressant combinations that are more and more powerful has an impact on adverse effects in recipients, including an increased incidence of infections, cancers, but also metabolic complications (diabetes, osteoporosis, dyslipidemia, etc.), which are cause of significant morbi-mortality.

In an attempt to improve on these disappointing outcomes, some teams have offered to perform screening biopsies: i.e. routine biopsies at specific time points during the follow up, irrespective of graft function. Their primary interest is to allow a pathological analysis of the graft at an early stage, i.e. when potential histological lesions allow for a diagnosis but before these lesions impact on graft's function. Indeed, it has been clearly demonstrated that therapeutic adjustments intended to protect the grafts are most effective when introduced early. There is a fairly broad consensus to perform these biopsies three months and one year after the transplantation. Performing screening biopsies has led to the identification of "subclinical" forms of rejection, i.e. graft infiltration by recipient immune effectors meeting the Banff histological criteria, but without increase in creatininemia.

Assuming that about 10% of screening biopsies performed at 3 months reveal a subclinical rejection, which needs to be treated, the management strategy for the remaining 90% of patients, whose biopsies show either i) a mild inflammatory infiltrates: i.e. "borderline changes", or ii) the complete absence of immune effectors in the graft is, poorly standardized.

The investigators therefore propose to conduct a prospective randomized trial to answer these questions simultaneously by evaluating a strategy to optimize the immunosuppression of renal graft recipients based on the presence or absence of subclinical intragraft inflammatory infiltrates in the screening biopsy performed at 3 months post transplantation. Patients with borderline changes (sub-study A) will be randomized to receive a treatment for rejection (corticosteroid boluses). Patients without inflammation in their graft (sub-study B) will be randomized for corticosteroid withdrawal. Impact on graft function, progression of histological lesions and incidence of morbidity will be evaluated.

location_facility: Service de Néphrologie,Transplantation, Dialyse I - Hôpital Pellegrin - CHU Bordeaux

location_facility: Département de Néphrologie et Transplantation d'Organes - Hôpital Rangueil - CHU de Toulouse

location_facility: Service de Néphrologie, Transplantation et Immunologie Clinique - Hôpital Edouard Herriot - Hospices Civils de Lyon

location_facility: Service Urgences Néphrologiques et Transplantation Rénale - Hôpital Tenon

location_facility: Institut de Transplantation, Urologie et Néphrologie (ITUN) - CHU de Nantes

location_facility: Unité de Transplantation Rénale - Hôpital Pasteur - CHU de Nice

location_facility: Service de Néphrologie et Transplantation - Nouvel Hôpital Civil - CHRU Strasbourg

location_facility: Service de Néphrologie, Hémodialyse, Transplantations Rénales - Hôpital de la Cavale Blanche - CHU de Brest

location_facility: Service de Néphrologie et Transplantation - Hôpital Saint-Louis

location_facility: Service de Transplantation - Hôpital Universitaire Necker

location_facility: Service de Néphrologie - Hôpital Claude Huriez - CHU de Lille


title: PilBouTox® Project: Prospective and Descriptive Study About Button Battery Poisoning Performed on Data Collected by French Poison Control Centres (PCC)

acronym: PILBOUTOX

summary: Button batteries are found in all householders and can be responsible for poisoning, in particular in children. Unexpected complications and death in children who have ingested button battery have been published for over twenty years in medical literature. There are many questions related to the treatment that remain unanswered, because some data are missing in previously published studies. The main objective of this study is to precisely describe poisoning cases by button battery in order to propose a better management


title: Phase II Study Evaluating the Efficacy of the Combination of Metformin to Neoadjuvant Radiochemotherapy in the Treatment of Locally Advanced Rectal Cancer.

summary:
Metformin is an oral antidiabetic of the biguanide class derived from galega officinalis. Historical cohort of patients with diabetes have shown that diabetics on Metformin had a better chance of survival than diabetics not on Metformin. These observations have led to in vitro studies of metformin on cancer cells. It was thus demonstrated that Metformin has anti-proliferative properties.

The aim of our study is to evaluate the efficacy of metformin in combination with neoadjuvant radiochemotherapy in the treatment of locally advanced rectal cancer.

lead_sponsor: Centre Oscar Lambret

location_facility: Centre Léonard de Vinci - SARL du pont Saint Vaast

location_facility: Centre Galilée - Hôpital Privé La Louvière