title: Assessment of the Impact of Relay Timing and CPRmeter Guidance on the Quality of External Chest Compression: Compression Is Life In Cardiac Arrest - Human Study (CILICA-HS).

acronym: CILICA-HS

summary:
The management of out-of-hospital cardiac arrest is complex and multifactorial. With an incidence between 5 and 15 per 10,000 (46,000 patients per year in France) and a survival rate of only 5% to 15%, the room for improvement remains significant even today and is based on fast and optimal care. Thus French and international recommendations insist on the central element of external chest compression (ECC) and especially its quality (Monsieurs KG and Al. Resuscitation 2015; 95: 1-80). Improving the chest compression fraction (CCF) by limiting time without cardiac massage (No-Flow) is a second major point of the recommendations (Vaillancourt C and Al. Resuscitation 2011; 82: 1501-7). The survival of cardiac arrest victims is closely related on this No-Flow time. The principle of the chain of survival (early warning - ECC - defibrillation - resuscitation) implies that the deterioration of a single link threaten the whole of the care. To meet these qualitative needs, ECC guidance devices have been developed. They make possible to improve the quality of the ECC achieved (Hostler D and Al. BMJ 2011; 342d512). Their use is one of the areas of improvement mentioned in the recommendations. Our team studied in simulation the prolonged effects of guidance on the quality of the ECC during a prolonged resuscitation, with encouraging results (Buléon C and Al. Am J Emerg Med 2016; 34: 1754-60). The investigators propose a study evaluating the efficiency of the guidance of the ECC and the impact of the time of relay on the CCF. The investigators formulate two hypotheses that they wish to test simultaneously using a 2x2 factorial design, in a multicenter randomized trial. The first assumption is that a 4-minute relay rate improves the CCF (by reducing the No-Flow time) compared to the currently recommended 2-minute relay rate. The second hypothesis is that a guiding device improves the quality of the ECC.

This study should, over a period of 2 years, include 500 patients with cardiac arrest for whom specialized resuscitation is undertaken. The investigators hope by this study to improve the knowledge on the optimal rhythm of the ECC and to validate "in vivo" the interest for the guidance found on manikin. This study should make it possible to clarify the recommendations with a high level of evidence in this field and thus contribute to improving the prognosis of the victims of an out-of-hospital cardiac arrest.

ReferenceCitation: International Liaison Committee on Resuscitation. 2005 International Consensus on Cardiopulmonary Resuscitation and Emergency Cardiovascular Care Science with Treatment Recommendations. Part 4: Advanced life support. Resuscitation. 2005 Nov-Dec;67(2-3):213-47.

ReferenceCitation: Nolan JP, Soar J, Zideman DA, Biarent D, Bossaert LL, Deakin C, Koster RW, Wyllie J, Böttiger B; ERC Guidelines Writing Group. European Resuscitation Council Guidelines for Resuscitation 2010 Section 1. Executive summary. Resuscitation. 2010 Oct;81(10):1219-76. doi: 10.1016/j.resuscitation.2010.08.021.

ReferenceCitation: Monsieurs KG, Nolan JP, Bossaert LL, Greif R, Maconochie IK, Nikolaou NI, Perkins GD, Soar J, Truhlář A, Wyllie J, Zideman DA; ERC Guidelines 2015 Writing Group. European Resuscitation Council Guidelines for Resuscitation 2015: Section 1. Executive summary. Resuscitation. 2015 Oct;95:1-80. doi: 10.1016/j.resuscitation.2015.07.038. Epub 2015 Oct 15.

ReferenceCitation: Christenson J, Andrusiek D, Everson-Stewart S, Kudenchuk P, Hostler D, Powell J, Callaway CW, Bishop D, Vaillancourt C, Davis D, Aufderheide TP, Idris A, Stouffer JA, Stiell I, Berg R; Resuscitation Outcomes Consortium Investigators. Chest compression fraction determines survival in patients with out-of-hospital ventricular fibrillation. Circulation. 2009 Sep 29;120(13):1241-7. doi: 10.1161/CIRCULATIONAHA.109.852202. Epub 2009 Sep 14.

ReferenceCitation: Wik L, Olsen JA, Persse D, Sterz F, Lozano M Jr, Brouwer MA, Westfall M, Souders CM, Travis DT, Herken UR, Lerner EB. Why do some studies find that CPR fraction is not a predictor of survival? Resuscitation. 2016 Jul;104:59-62. doi: 10.1016/j.resuscitation.2016.04.013. Epub 2016 May 4.

ReferenceCitation: Berg RA, Sanders AB, Kern KB, Hilwig RW, Heidenreich JW, Porter ME, Ewy GA. Adverse hemodynamic effects of interrupting chest compressions for rescue breathing during cardiopulmonary resuscitation for ventricular fibrillation cardiac arrest. Circulation. 2001 Nov 13;104(20):2465-70.

ReferenceCitation: Cunningham LM, Mattu A, O'Connor RE, Brady WJ. Cardiopulmonary resuscitation for cardiac arrest: the importance of uninterrupted chest compressions in cardiac arrest resuscitation. Am J Emerg Med. 2012 Oct;30(8):1630-8. doi: 10.1016/j.ajem.2012.02.015. Epub 2012 May 23. Review.

ReferenceCitation: Kleinman ME, Brennan EE, Goldberger ZD, Swor RA, Terry M, Bobrow BJ, Gazmuri RJ, Travers AH, Rea T. Part 5: Adult Basic Life Support and Cardiopulmonary Resuscitation Quality: 2015 American Heart Association Guidelines Update for Cardiopulmonary Resuscitation and Emergency Cardiovascular Care. Circulation. 2015 Nov 3;132(18 Suppl 2):S414-35. doi: 10.1161/CIR.0000000000000259. Review.

ReferenceCitation: Perkins GD, Jacobs IG, Nadkarni VM, Berg RA, Bhanji F, Biarent D, Bossaert LL, Brett SJ, Chamberlain D, de Caen AR, Deakin CD, Finn JC, Gräsner JT, Hazinski MF, Iwami T, Koster RW, Lim SH, Ma MH, McNally BF, Morley PT, Morrison LJ, Monsieurs KG, Montgomery W, Nichol G, Okada K, Ong ME, Travers AH, Nolan JP; Utstein Collaborators. Cardiac Arrest and Cardiopulmonary Resuscitation Outcome Reports: Update of the Utstein Resuscitation Registry Templates for Out-of-Hospital Cardiac Arrest: A Statement for Healthcare Professionals From a Task Force of the International Liaison Committee on Resuscitation (American Heart Association, European Resuscitation Council, Australian and New Zealand Council on Resuscitation, Heart and Stroke Foundation of Canada, InterAmerican Heart Foundation, Resuscitation Council of Southern Africa, Resuscitation Council of Asia); and the American Heart Association Emergency Cardiovascular Care Committee and the Council on Cardiopulmonary, Critical Care, Perioperative and Resuscitation. Resuscitation. 2015 Nov;96:328-40. doi: 10.1016/j.resuscitation.2014.11.002. Epub 2014 Nov 11.

ReferenceCitation: Cheskes S, Schmicker RH, Rea T, Morrison LJ, Grunau B, Drennan IR, Leroux B, Vaillancourt C, Schmidt TA, Koller AC, Kudenchuk P, Aufderheide TP, Herren H, Flickinger KH, Charleston M, Straight R, Christenson J; ROC investigators. The association between AHA CPR quality guideline compliance and clinical outcomes from out-of-hospital cardiac arrest. Resuscitation. 2017 Jul;116:39-45. doi: 10.1016/j.resuscitation.2017.05.003. Epub 2017 May 2.

ReferenceCitation: Hostler D, Everson-Stewart S, Rea TD, Stiell IG, Callaway CW, Kudenchuk PJ, Sears GK, Emerson SS, Nichol G; Resuscitation Outcomes Consortium Investigators. Effect of real-time feedback during cardiopulmonary resuscitation outside hospital: prospective, cluster-randomised trial. BMJ. 2011 Feb 4;342:d512. doi: 10.1136/bmj.d512.

ReferenceCitation: Buléon C, Delaunay J, Parienti JJ, Halbout L, Arrot X, Gérard JL, Hanouz JL. Impact of a feedback device on chest compression quality during extended manikin CPR: a randomized crossover study. Am J Emerg Med. 2016 Sep;34(9):1754-60. doi: 10.1016/j.ajem.2016.05.077. Epub 2016 May 28.

ReferenceCitation: Goodloe JM, Idris AH. Metrics save lives: value and hurdles faced. Curr Opin Crit Care. 2017 Jun;23(3):204-208. doi: 10.1097/MCC.0000000000000408. Review.

ReferenceCitation: Lin S, Scales DC. Cardiopulmonary resuscitation quality and beyond: the need to improve real-time feedback and physiologic monitoring. Crit Care. 2016 Jun 28;20(1):182. doi: 10.1186/s13054-016-1371-9.

ReferenceCitation: Cheskes S, Byers A, Zhan C, Verbeek PR, Ko D, Drennan IR, Buick JE, Brooks SC, Lin S, Taher A, Morrison LJ; Rescu Epistry Investigators. CPR quality during out-of-hospital cardiac arrest transport. Resuscitation. 2017 May;114:34-39. doi: 10.1016/j.resuscitation.2017.02.016. Epub 2017 Feb 24.

ReferenceCitation: Wallace SK, Abella BS, Becker LB. Quantifying the effect of cardiopulmonary resuscitation quality on cardiac arrest outcome: a systematic review and meta-analysis. Circ Cardiovasc Qual Outcomes. 2013 Mar 1;6(2):148-56. doi: 10.1161/CIRCOUTCOMES.111.000041. Epub 2013 Mar 12. Review.

ReferenceCitation: Buléon C, Parienti JJ, Morilland-Lecoq E, Halbout L, Cesaréo E, Dubien PY, Jardel B, Boyer C, Husson K, Andriamirado F, Benet X, Morel-Marechal E, Aubrion A, Muntean C, Dupire E, Roupie E, Hubert H, Vilhelm C, Gueugniaud PY; CILICA-HS study group. Impacts of chest compression cycle length and real-time feedback with a CPRmeter® on chest compression quality in out-of-hospital cardiac arrest: study protocol for a multicenter randomized controlled factorial plan trial. Trials. 2020 Jul 8;21(1):627. doi: 10.1186/s13063-020-04536-3.

family: Buléon

full_name: Clément Buléon

given: Clément

family: Parienti

full_name: Jean-Jacques Parienti

given: Jean-Jacques

family: Morilland-Lecoq

full_name: Elodie Morilland-Lecoq

given: Elodie

family: Halbout

full_name: Laurent Halbout

given: Laurent

family: Cesaréo

full_name: Eric Cesaréo

given: Eric

family: Dubien

full_name: Pierre-Yves Dubien

given: Pierre-Yves

family: Jardel

full_name: Benoit Jardel

given: Benoit

family: Boyer

full_name: Christophe Boyer

given: Christophe

family: Husson

full_name: Kévin Husson

given: Kévin

family: Andriamirado

full_name: Florian Andriamirado

given: Florian

family: Benet

full_name: Xavier Benet

given: Xavier

family: Morel-Marechal

full_name: Emmanuel Morel-Marechal

given: Emmanuel

family: Aubrion

full_name: Antoine Aubrion

family: Muntean

full_name: Catalin Muntean

given: Catalin

family: Dupire

full_name: Erwan Dupire

given: Erwan

family: Roupie

full_name: Eric Roupie

family: Hubert

full_name: Hervé Hubert

given: Hervé

family: Vilhelm

full_name: Christian Vilhelm

given: Christian

family: Gueugniaud

full_name: Pierre-Yves Gueugniaud

location_facility: Hospital of Elbeuf Louviers Val de Reuil


type: Other Identifier

title: Evaluation of a Dynamic Focusing Ultrasonic Transducer for High Intensity Focused Ultrasound (HIFU) Treatment of Localized Prostate Adenocarcinoma - Dose Escalation Trial to Define the Best Acoustic Parameters

acronym: FOC/DYN

summary: Define the best acoustic parameters for the dynamic focusing HIFU transducer in the treatment of localized Prostate Cancer.

status: Unknown status

study_completion_date_type: Anticipated

study_type: Interventional

primary_purpose: Treatment

enrollment_type: Actual

lead_sponsor: EDAP TMS S.A.

intervention_type: Device

lead_sponsor_type: industriel

status_simplified: Unknown


title: Impact of EDUcation Strategy on Patients With COLorectal CANCER or Advanced Adenoma in the Detection of Colorectal Cancer of Their First-degree Relatives - Randomized, Multicenter Cluster Test

acronym: EDUCANCOLAGE

summary:
The relative risk of colorectal cancer (CRC) is increased in first-degree relatives of patients with CRC or advanced adenoma. In the high-risk CCR population defined by a family history at the first stage of CRC or advanced adenoma before age 60, total colonoscopy is the recommended screening test. In France, the rate of screening colonoscopy in this population at high risk of CRC is insufficient, which limits the effectiveness of this targeted screening.

The main reason for this low participation rate is that most patients undergoing RCC or advanced adenoma are unaware of the family implications of their diagnosis and therefore reluctant to disseminate this information to their patients Related matters. The need for a better perception of the personal risk of CRC in first-degree relatives of patients with CRC or advanced adenoma, with the expected coronary adherence to increasing screening, requires a good understanding of risk through Clear, adapted and comprehensible information that can be relayed personally by the case-index.

The objective of this project is to develop a personalized prevention and screening program for the JRC in order to meet the needs of the relatives of the sick. The means of intervention that will be implemented respond to the need to better take into account the level of CRC risk in a family-based CRC screening and prevention approach adapted to a high-risk CRC group characterized by Family history at the first stage of CRC or advanced adenoma and, consequently, to improve the information of the subjects concerned by screening and prevention of CRC.

The aim of the case-index education is to induce its intervention with its relatives to promote CCR screening. The use of the index case, as a means of providing information to relatives, implies an educational and psychological approach, based on evidence, but adapted and personalized.

study_start_date_type: Actual

status: Completed

study_completion_date_type: Actual

design_allocation: Randomized

primary_purpose: Prevention

lead_sponsor: University Hospital, Tours

location_facility: Service d'Hépatogastro-entérologie CHRU de TOURS

location_facility: Service d'Hépatogastro-entérologie CHG de DREUX

location_facility: Service d'Hépatogastro-entérologie CHR d'Orléans

location_facility: Service d'Hépatogastro-entérologie CHU POITIERS

location_facility: Service d'Hépatogastro-entérologie CHU ANGERS

location_facility: Service d'Hépatogastro-entérologie CHG BLOIS

location_facility: Service d'Hépatogastro-entérologie CHU de NANTES

intervention_type: Behavioral

lead_sponsor_type: academique

status_simplified: Completed


title: Randomised, Opened, Multicentre Phase I/II Trial in Patients With Chronic Hepatitis B With HBV VL < 12 IU/ml and Under Treatment With NRTI, Which Evaluated Efficacy and Tolerance of Vaccination With Naked DNA on Viral Replication After Analogs' Treatment Interruption. ANRS HB02 VAC-ADN

acronym: VAC-ADN

summary: The purpose of this study is to determine if DNA vaccination of chronic HBV patients under treatment with NRTI can restore T-cell responsiveness and delay virologic reactivation after treatment discontinuation.

ReferenceType: background

ReferenceCitation: Mancini-Bourgine M, Fontaine H, Bréchot C, Pol S, Michel ML. Immunogenicity of a hepatitis B DNA vaccine administered to chronic HBV carriers. Vaccine. 2006 May 22;24(21):4482-9. Epub 2005 Aug 18.

ReferenceCitation: Mancini-Bourgine M, Fontaine H, Scott-Algara D, Pol S, Bréchot C, Michel ML. Induction or expansion of T-cell responses by a hepatitis B DNA vaccine administered to chronic HBV carriers. Hepatology. 2004 Oct;40(4):874-82.

ReferenceType: derived

ReferenceCitation: Fontaine H, Kahi S, Chazallon C, Bourgine M, Varaut A, Buffet C, Godon O, Meritet JF, Saïdi Y, Michel ML, Scott-Algara D, Aboulker JP, Pol S; ANRS HB02 study group. Anti-HBV DNA vaccination does not prevent relapse after discontinuation of analogues in the treatment of chronic hepatitis B: a randomised trial--ANRS HB02 VAC-ADN. Gut. 2015 Jan;64(1):139-47. doi: 10.1136/gutjnl-2013-305707. Epub 2014 Feb 20.

family: Fontaine

full_name: H Fontaine

given: H

sequence: first

family: Kahi

full_name: S Kahi

given: S

sequence: additional

family: Chazallon

full_name: C Chazallon

given: C

family: Bourgine

full_name: M Bourgine

given: M

family: Varaut

full_name: A Varaut

given: A

family: Buffet

full_name: C Buffet

family: Godon

full_name: O Godon

given: O

family: Meritet

full_name: J F Meritet

given: J F

family: Saïdi

full_name: Y Saïdi

given: Y

family: Michel

full_name: M L Michel

given: M L

family: Scott-Algara

full_name: D Scott-Algara

given: D

family: Aboulker

full_name: J P Aboulker

given: J P

family: Pol

full_name: S Pol

bso_classification: Medical research

datasource: user

genre: journal-article

genre_raw: journal-article

journal_name: Gut

publisher: BMJ

publisher_dissemination: British Medical Journal

publisher_group: British Medical Journal

publisher_normalized: British Medical Journal

title: Anti-HBV DNA vaccination does not prevent relapse after discontinuation of analogues in the treatment of chronic hepatitis B: a randomised trial—ANRS HB02 VAC-ADN

ReferenceCitation: Godon O, Fontaine H, Kahi S, Meritet JF, Scott-Algara D, Pol S, Michel ML, Bourgine M; ANRS HB02 study group. Immunological and antiviral responses after therapeutic DNA immunization in chronic hepatitis B patients efficiently treated by analogues. Mol Ther. 2014 Mar;22(3):675-684. doi: 10.1038/mt.2013.274. Epub 2013 Dec 5.

full_name: JF Meritet

given: JF

full_name: ML Michel

given: ML

title: Immunological and Antiviral Responses After Therapeutic DNA Immunization in Chronic Hepatitis B Patients Efficiently Treated by Analogues

lead_sponsor: French National Agency for Research on AIDS and Viral Hepatitis


title: Early Rehabilitation Combining Daily Electrical Muscle Stimulation and Early Bedside Cycling Exercise, Compared to Early Standard Rehabilitation. A Randomized, Assessor-blinded, Single-center Study in Intensive Care Patients.

summary:
Early mobilization (from the first day if possible), first passive and then passive and active, is recommended for critically ill patients in whom it reduces the duration of mechanical ventilation, the length of hospital stay, improves functional status, muscle strength and quality of life after hospital discharge. The early addition of leg bicycling on a cyclo-ergometer is now part of common practice in the ICU. It can preserve or improve muscle strength and further increase the beneficial effects of early mobilization. Electrical muscle stimulation of the quadriceps, is practiced in some intensive care units, and it should, in theory, also through an improvement of muscle strength, increase the beneficial effects of early mobilization.

We hypothesized that early quadriceps electrical stimulation and early work on a cyclo-ergometer associated with a standard protocol of early passive/active mobilization in the ICU may improve muscle function and reduce the duration of mechanical ventilation, length of stay, the number of readmissions and improve the quality of life in the mid term in critically ill patients, as compared to a conventional protocol of early passive/active mobilization.

ReferenceCitation: Fossat G, Baudin F, Courtes L, Bobet S, Dupont A, Bretagnol A, Benzekri-Lefèvre D, Kamel T, Muller G, Bercault N, Barbier F, Runge I, Nay MA, Skarzynski M, Mathonnet A, Boulain T. Effect of In-Bed Leg Cycling and Electrical Stimulation of the Quadriceps on Global Muscle Strength in Critically Ill Adults: A Randomized Clinical Trial. JAMA. 2018 Jul 24;320(4):368-378. doi: 10.1001/jama.2018.9592.

name: Service de Médecine Intensive Réanimation, Centre Hospitalier Régional d’Orléans, Orléans, France

family: Fossat

full_name: Guillaume Fossat

given: Guillaume

family: Baudin

full_name: Florian Baudin

given: Florian

family: Courtes

full_name: Léa Courtes

given: Léa

family: Bobet

full_name: Sabrine Bobet

given: Sabrine

name: Service de Réanimation Chirurgicale, Centre Hospitalier Régional d’Orléans, Orléans, France

family: Dupont

full_name: Arnaud Dupont

given: Arnaud

family: Bretagnol

full_name: Anne Bretagnol

given: Anne

family: Benzekri-Lefèvre

full_name: Dalila Benzekri-Lefèvre

given: Dalila

family: Kamel

full_name: Toufik Kamel

given: Toufik

family: Muller

full_name: Grégoire Muller

given: Grégoire

family: Bercault

full_name: Nicolas Bercault

given: Nicolas

family: Barbier

full_name: François Barbier

given: François

family: Runge

full_name: Isabelle Runge

given: Isabelle

family: Nay

full_name: Mai-Anh Nay

given: Mai-Anh

family: Skarzynski

full_name: Marie Skarzynski

given: Marie

family: Mathonnet

full_name: Armelle Mathonnet

given: Armelle

family: Boulain

full_name: Thierry Boulain

given: Thierry

journal_name: JAMA

oa_colors: green other

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: PubMed Central - Europe PMC

repository_normalized: PubMed Central

evidence: oa repository (via pmcid lookup)

publisher: American Medical Association (AMA)

publisher_dissemination: American Medical Association

publisher_group: American Medical Association

publisher_normalized: American Medical Association

lead_sponsor: Centre Hospitalier Régional d'Orléans


type: EudraCT Number

title: Effect of Intravenous Hydrocortison on Post-ischemic Brachial Artery Dilation and on Thenar Oxygen Saturation in Adult Septic Shock. A Human Placebo-controlled Randomized Study.

acronym: HyStOON

summary: The main objectives of the study are 1)to examine the immediate (2 hours) and delayed (8 hours) effects of intravenous hydrocortison on macro and microvascular post-ischemic vasoreactivity, in septic shock adult patients; 2) to examine possible correlations between post-ischemic flow-mediated dilation (FMD) of the brachial artery (assessed by ultrasound imaging) and post-ischemic recovery slope of the thenar oxygen saturation (StO2) (assessed by near-infrared spectroscopy).

status: Terminated

intervention_type: Drug


title: Evaluation of 11 C-Choline PET-CT for Detection of Hepatocellular Carcinoma

acronym: CHOLPET

summary:
Hepatocellular carcinoma (HCC)is the most frequent primitive tumour of the liver.

Recently, several research studies reported that 11C-choline PET has shown a high detection rate of well differentiated HCC, which is an early stage of primary liver cancer. The aim of this study was to prospectively evaluate the diagnostic accuracy of 11C-choline PET-CT to detect HCC in cirrhotic or non cirrhotic patients.

design_allocation: Non-Randomized

primary_purpose: Diagnostic

enrollment_type: Anticipated

ReferenceCitation: Talbot JN, Fartoux L, Balogova S, Nataf V, Kerrou K, Gutman F, Huchet V, Ancel D, Grange JD, Rosmorduc O. Detection of hepatocellular carcinoma with PET/CT: a prospective comparison of 18F-fluorocholine and 18F-FDG in patients with cirrhosis or chronic liver disease. J Nucl Med. 2010 Nov;51(11):1699-706. doi: 10.2967/jnumed.110.075507. Epub 2010 Oct 18.

ReferenceCitation: Tolvanen T, Yli-Kerttula T, Ujula T, Autio A, Lehikoinen P, Minn H, Roivainen A. Biodistribution and radiation dosimetry of [(11)C]choline: a comparison between rat and human data. Eur J Nucl Med Mol Imaging. 2010 May;37(5):874-83. doi: 10.1007/s00259-009-1346-z. Epub 2010 Jan 13.

ReferenceCitation: Park JW, Kim JH, Kim SK, Kang KW, Park KW, Choi JI, Lee WJ, Kim CM, Nam BH. A prospective evaluation of 18F-FDG and 11C-acetate PET/CT for detection of primary and metastatic hepatocellular carcinoma. J Nucl Med. 2008 Dec;49(12):1912-21. doi: 10.2967/jnumed.108.055087. Epub 2008 Nov 7.

ReferenceCitation: Ho CL, Yu SC, Yeung DW. 11C-acetate PET imaging in hepatocellular carcinoma and other liver masses. J Nucl Med. 2003 Feb;44(2):213-21.

ReferenceCitation: Hwang KH, Choi DJ, Lee SY, Lee MK, Choe W. Evaluation of patients with hepatocellular carcinomas using [(11)C]acetate and [(18)F]FDG PET/CT: A preliminary study. Appl Radiat Isot. 2009 Jul-Aug;67(7-8):1195-8. doi: 10.1016/j.apradiso.2009.02.011. Epub 2009 Feb 20.

ReferenceCitation: Talbot JN, Gutman F, Fartoux L, Grange JD, Ganne N, Kerrou K, Grahek D, Montravers F, Poupon R, Rosmorduc O. PET/CT in patients with hepatocellular carcinoma using [(18)F]fluorocholine: preliminary comparison with [(18)F]FDG PET/CT. Eur J Nucl Med Mol Imaging. 2006 Nov;33(11):1285-9. Epub 2006 Jun 27.

ReferenceCitation: Yamamoto Y, Nishiyama Y, Kameyama R, Okano K, Kashiwagi H, Deguchi A, Kaji M, Ohkawa M. Detection of hepatocellular carcinoma using 11C-choline PET: comparison with 18F-FDG PET. J Nucl Med. 2008 Aug;49(8):1245-8. doi: 10.2967/jnumed.108.052639. Epub 2008 Jul 16.

ReferenceCitation: Salem N, Kuang Y, Wang F, Maclennan GT, Lee Z. PET imaging of hepatocellular carcinoma with 2-deoxy-2[18F]fluoro-D-glucose, 6-deoxy-6[18F] fluoro-D-glucose, [1-11C]-acetate and [N-methyl-11C]-choline. Q J Nucl Med Mol Imaging. 2009 Apr;53(2):144-56. Epub 2008 Nov 28.

ReferenceCitation: Hara T, Kosaka N, Shinoura N, Kondo T. PET imaging of brain tumor with [methyl-11C]choline. J Nucl Med. 1997 Jun;38(6):842-7.

ReferenceCitation: Hara T, Kosaka N, Kishi H. PET imaging of prostate cancer using carbon-11-choline. J Nucl Med. 1998 Jun;39(6):990-5.

ReferenceCitation: Li CW, Kuo YC, Chen CY, Kuo YT, Chiu YY, She FO, Liu GC. Quantification of choline compounds in human hepatic tumors by proton MR spectroscopy at 3 T. Magn Reson Med. 2005 Apr;53(4):770-6.

ReferenceCitation: Kojiro M, Roskams T. Early hepatocellular carcinoma and dysplastic nodules. Semin Liver Dis. 2005;25(2):133-42. Review.

ReferenceCitation: Kim HO, Kim JS, Shin YM, Ryu JS, Lee YS, Lee SG. Evaluation of metabolic characteristics and viability of lipiodolized hepatocellular carcinomas using 18F-FDG PET/CT. J Nucl Med. 2010 Dec;51(12):1849-56. doi: 10.2967/jnumed.110.079244.

ReferenceCitation: Kim YK, Lee KW, Cho SY, Han SS, Kim SH, Kim SK, Park SJ. Usefulness 18F-FDG positron emission tomography/computed tomography for detecting recurrence of hepatocellular carcinoma in posttransplant patients. Liver Transpl. 2010 Jun;16(6):767-72. doi: 10.1002/lt.22069.

ReferenceCitation: Wolfort RM, Papillion PW, Turnage RH, Lillien DL, Ramaswamy MR, Zibari GB. Role of FDG-PET in the evaluation and staging of hepatocellular carcinoma with comparison of tumor size, AFP level, and histologic grade. Int Surg. 2010 Jan-Mar;95(1):67-75.

ReferenceCitation: Khan MA, Combs CS, Brunt EM, Lowe VJ, Wolverson MK, Solomon H, Collins BT, Di Bisceglie AM. Positron emission tomography scanning in the evaluation of hepatocellular carcinoma. J Hepatol. 2000 May;32(5):792-7.

ReferenceCitation: Delbeke D, Martin WH, Sandler MP, Chapman WC, Wright JK Jr, Pinson CW. Evaluation of benign vs malignant hepatic lesions with positron emission tomography. Arch Surg. 1998 May;133(5):510-5; discussion 515-6.

ReferenceCitation: Okazumi S, Isono K, Enomoto K, Kikuchi T, Ozaki M, Yamamoto H, Hayashi H, Asano T, Ryu M. Evaluation of liver tumors using fluorine-18-fluorodeoxyglucose PET: characterization of tumor and assessment of effect of treatment. J Nucl Med. 1992 Mar;33(3):333-9.

ReferenceCitation: Bruix J, Sherman M; Practice Guidelines Committee, American Association for the Study of Liver Diseases. Management of hepatocellular carcinoma. Hepatology. 2005 Nov;42(5):1208-36.

ReferenceCitation: Bruix J, Sherman M, Llovet JM, Beaugrand M, Lencioni R, Burroughs AK, Christensen E, Pagliaro L, Colombo M, Rodés J; EASL Panel of Experts on HCC. Clinical management of hepatocellular carcinoma. Conclusions of the Barcelona-2000 EASL conference. European Association for the Study of the Liver. J Hepatol. 2001 Sep;35(3):421-30.

lead_sponsor: Commissariat A L'energie Atomique


title: Use of RDS MultiSense® in Post-ICU Patients in the COVID-19 Era

acronym: MONIREA

summary: In this clinical study, the investigators will compare vital parameters measurements obtained using continuous data from reference monitors and continuous wireless MultiSense® monitoring patch in 60 post-ICU (Intensive Care Unit) patients and over 7 days.

study_start_date_type: Anticipated

status: Not yet recruiting

primary_purpose: Other

ipd_sharing: No

lead_sponsor: IHU Strasbourg

location_facility: Anesthesia, Critical Care & Perioperative Medicine, Hautepierre

intervention_type: Other

status_simplified: Ongoing


title: Primary-Pneumocystis Infection: Pneumocystis Jirovecii Detection in Nasopharyngeal Aspirates From Symptomatic Infants

acronym: CAPRI-PC

summary: To determine the prevalence of P. jirovecii in nasopharyngeal aspirations of neonates and infants hospitalized for symptomatic respiratory infection.

study_type: Observational

time_perspective: Prospective

lead_sponsor: University Hospital, Brest


title: ANRS HB 05 : A Randomized, Double Blind, Multicenter Study Evaluating Efficacy and Safety of Clevudine Monotherapy Versus Tenofovir Monotherapy Versus Combination Therapy of Clevudine and Tenofovir for 96 Weeks in HBeAg Negative Patients With Chronic Hepatitis B, naïve to Anti-VHB Therapy

summary: For chronic HBV infection, an optimal pharmacological agent to promote recovery from chronic HBV infection would be one that inhibits HBV DNA polymerase, combined with the clearence from the liver of cccDNA to block HBV reactivation after the circulating viral burden has been eliminated by therapy. The activity of clevudine on cccDNA in combination with its potent antiviral activity on HBV polymerase makes it the optimal agent in combination with tenofovir for this protocol.


title: Evaluation of Nasal Ventilation on Optimizing Swallowing in Ventilated Neuromuscular Patients

acronym: OPTIDEG

summary:
Neuromuscular disorders can be associated with swallowing dysfunction secondary to a dysfunction of the airway muscles involved in swallowing. The investigators have shown that respiratory failure may contribute to swallowing dysfunction in patients with neuromuscular respiratory failure. Furthermore, although tracheostomy has been reported as impairing swallowing, the investigators have shown that when a tracheostomy is performed in neuromuscular patients, swallowing improves because it allows the patient to feed while ventilated.

The investigators now want to evaluate whether non invasive ventilation may have a beneficial impact on swallowing by making some adjustments to ensure a good synchronisation between ventilation and swallowing. This could allow avoiding the necessity of a tracheostomy or a gastrostomy due to swallowing dysfunction and/or malnutrition in neuromuscular patients.

Swallowing improvement under mechanical ventilation depends on improving the synchronisation between the patient and the ventilator during swallowing. For that purpose, the investigators developed a prototype ventilator able to temporarily suspend pressurisation under the patient's control so that when the patient needs to swallow under mechanical ventilation he may do so with an inadequate insufflation of the ventilator.

Our objective is to to demonstrate that swallowing is more adapted and easier under nasal noninvasive ventilation than during spontaneous breathing in neuromuscular patients requiring prolonged noninvasive ventilation.

In an open monocentric pilot study, the investigators will study 10 neuromuscular patients usually noninvasively ventilated. The patients will be their own control and their swallow will be studied during spontaneous breathing and under ventilation with the adapted ventilator while swallowing boluses of different volumes.

primary_purpose: Supportive Care

ReferenceCitation: Prigent H, Lejaille M, Terzi N, Annane D, Figere M, Orlikowski D, Lofaso F. Effect of a tracheostomy speaking valve on breathing-swallowing interaction. Intensive Care Med. 2012 Jan;38(1):85-90. doi: 10.1007/s00134-011-2417-8. Epub 2011 Nov 24.

ReferenceCitation: Terzi N, Prigent H, Lejaille M, Falaize L, Annane D, Orlikowski D, Lofaso F. Impact of tracheostomy on swallowing performance in Duchenne muscular dystrophy. Neuromuscul Disord. 2010 Aug;20(8):493-8. doi: 10.1016/j.nmd.2010.05.009. Epub 2010 Jun 16.

ReferenceCitation: Terzi N, Orlikowski D, Aegerter P, Lejaille M, Ruquet M, Zalcman G, Fermanian C, Raphael JC, Lofaso F. Breathing-swallowing interaction in neuromuscular patients: a physiological evaluation. Am J Respir Crit Care Med. 2007 Feb 1;175(3):269-76. Epub 2006 Nov 16.

ReferenceCitation: Garguilo M, Lejaille M, Vaugier I, Orlikowski D, Terzi N, Lofaso F, Prigent H. Noninvasive Mechanical Ventilation Improves Breathing-Swallowing Interaction of Ventilator Dependent Neuromuscular Patients: A Prospective Crossover Study. PLoS One. 2016 Mar 3;11(3):e0148673. doi: 10.1371/journal.pone.0148673. eCollection 2016.

family: Garguilo

full_name: Marine Garguilo

given: Marine

family: Lejaille

full_name: Michèle Lejaille

given: Michèle

family: Vaugier

full_name: Isabelle Vaugier

family: Orlikowski

full_name: David Orlikowski

given: David

family: Terzi

full_name: Nicolas Terzi

family: Lofaso

full_name: Frédéric Lofaso

given: Frédéric

family: Prigent

full_name: Hélène Prigent

given: Hélène

currency_apc_doaj: USD

journal_name: PLOS ONE

oa_colors: green gold

evidence: oa journal (via doaj)

license: cc-by

license_normalized: cc-by

repository_institution: La Trobe University - OPAL (Open@LaTrobe)

version: submittedVersion

evidence: oa repository (semantic scholar lookup)

publisher: Public Library of Science (PLoS)

publisher_dissemination: Public Library of Science

publisher_group: Public Library of Science

publisher_normalized: Public Library of Science

lead_sponsor: Centre d'Investigation Clinique et Technologique 805


title: Pessary to Prevent Prematurity in Twins in Case of Short Cervix

acronym: PESSAR'ONE

summary: For 25 years, the twin pregnancy rate has regularly increased in the majority of European countries and in the United States, by 35% between 1981 and 2006. Increased use of medically assisted procreation and older maternal age are the two main causes. At the present time twin pregnancies represent nearly 20% of premature deliveries. The rate of very premature births (< 32-34 weeks) is 7 times higher in twin pregnancies than in singleton pregnancies. As prematurity accounts for 75% of neonatal morbidity and mortality, and extreme prematurity is the principal cause of neonatal mortality and of brain sequelae in twins, the search for a preventive treatment appears as a priority in perinatal medicine. The investigators recently showed in a prospective multicenter study that cervical ultrasound at 22 and 27 wks was a better predictive investigation of premature delivery < 34 wks than digital examination. Recently in a randomized trial in a population of short-cervix singleton pregnancies, the premature delivery rate decreased by 40% in the pessary group compared with the usual management group. No other trial of pessary use in short-cervix twin pregnancies was published today. Recently, in a historical comparison of twins with twin-to-twin transfusion syndrome treated with laser, Carreras et al. have showed a decreased rate of preterm delivery with the use of pessary in case of short cervix. The investigators wish to set up a randomized multicenter study in France in the population of short-cervix twin pregnancies to show a potential benefit of the pessary compared with simple surveillance.

lead_sponsor: University Hospital, Toulouse

location_facility:
CHU Angers
CHRU Lille
Hôpital Necker
CHU Toulouse
Hôpital Marseille AP-HM
GH Pitié Salpétriêre
Maternité Port-Royal Cochin
CHU Caen
Hôpital Saint-Joseph
Hôpital Antoine Béclère
CHU Bordeaux
Hôpital Robert Debré
CHI Poissy
CHU Nantes
CHU Saint-Etienne
Hôpital Universitaire de Strasbourg
CHU Tours
Hôpital Bicêtre


lead_sponsor: Olympus Biotech Corporation

location_country:
Italy
Czech Republic
France
Hungary

acronym: TRANS-South

source: euctr

title: A Phase III, Double-Blind, Placebo Controlled, Parallel Group, International, Multicenter Study of 12 Weeks Treatment With Trafermin 0.01% Spray in Patients With Diabetic Foot Ulcer of Neuropathic Origin

summary:
Trafermin is a recombinant human basic fibroblast growth factor (bFGF; original development code, KCB-1), which is manufactured by genetic engineering using Escherichia coli by Kaken Pharmaceutical Co., Ltd. (Tokyo, Japan). Trafermin 0.01% cutaneous spray product kit consisting of a glass bottle containing lyophilized trafermin, a glass bottle with solvent for solution and a spray part to fit the glass bottle after reconstitution of the final product.

The investigators conduct a multinational, randomized, double-blind, placebo controlled, parallel-group, multicentre study consisting of a placebo run-in phase (2w), a treatment phase (max. 12w) and a follow-up phase (3mo+6mo). The primary objective of the study is to demonstrate a superior wound closure rate of diabetic foot ulcers (DFUs) of neuropathic origin after 12 weeks topical daily application of trafermin 0.01% spray compared with placebo, in addition to best local care (off-loading, dressings). Approximately 210 patients will be randomized and it is planned that this study will be conducted at approximately 30 investigational sites in an estimated 4 countries in Europe (Czech Republic,France,Hungary,Italy,).


lead_sponsor: Assistance Publique - Hôpitaux de Paris

acronym: AJIBIOREM

title: Treatment Tapering in Oligoarticular or Rheumatoid Factor Negative Polyarticular Juvenile Idiopathic Arthritis With Inactive Disease on Biologic Therapy

summary: As biologic treatments are expensive and associated with some concerns regarding long-term safety, investigator hypothesize that early tapering and then withdrawal of biological agent, in an homogenous group of children with juvenile idiopathic arthritis achieving inactive disease, is safe and not inferior to the maintenance of stable treatment intensity over 24 weeks. In addition, investigator also hypothesize that an earlier tapering of treatment is associated with a better quality-of-life and a general cost saving effect. MRP8/14 will be studied as a potential biomarker for the risk of relapse. A study for biologic agent, anti-biologic agent antibodies and a pharmacogenomic approach will complete the research, as pharmacokinetic study during withdrawal of biologic treatment are rare in children.


title: A Multicenter Randomized Phase II Study Evaluating Tolerance and Efficacy of Capecitabine 5/7 Days With Weekly Paclitaxel Versus the Recommended Treatment Plan of Weekly Paclitaxel-capecitabine, in Patients With Metastatic Breast Cancer.

summary: Tolerance and efficacy of administration of capecitabine 5 out of 7 days associated with weekly paclitaxel compared to the recommended treatment plan of weekly paclitaxel - capecitabine, in patients with metastatic breast cancer.

lead_sponsor: ARCAGY/ GINECO GROUP


title: Ultrafiltration Versus Medical Therapies in the Management of the Cardio Renal Syndrome

acronym: UF-CARE

summary:
Type 2 cardio renal syndrome is defined by the occurrence or the exacerbation of a kidney failure induced by a chronic heart failure. Sodium overload is one of the main causes leading to the occurrence or the exacerbation of this syndrome. Some patients have a massive sodium retention on which medications are not effective enough. These patients have no further therapeutic options because of the refractory congestion and a 3-months mortality rate around 15%, frequent rehospitalization (3-months rehospitalization rate at 71%) and an excessively impaired quality of life.

For those refractory heart failure with cardio renal syndrome, nephrology departments resort to non-medication sodium extraction (hemodialysis, peritoneal dialysis, isolated ultrafiltration). Between 2002 and 2008, 927 French patients would have start dialysis in this situation. In 2013, 174 patients start dialysis in 97 dialysis centers. French National Authority of Health recently published new Good Practice Guidance thereupon, strengthened by the increasing number of publications and the widespread use of this technique. There is therefore a consensus among professionals about the benefits of such a technique in those indications. However, bibliographical data are not strong enough to support a strong level of evidence. None of foresight strategies have been compared to others in a proper randomized controlled trial, and there is no clue about any suspected superiority from one strategy to another.

So far, the investigators propound invasive, expensive and not validated techniques to patients with functional and vital prognosis altered. The investigators think it's essential to prove the efficacy of such an approach. They wish to quantify those techniques impact on rehospitalization, with a consideration for the potential survival impact.

It seems unethical to evaluate separated techniques, taking in account that patients with severe heart failure will switch from one technique to another among their care. It is therefore crucial to validate benefits from an invasive procedure (hemodialysis, peritoneal dialysis, isolated ultrafiltration) compared to a medication-restricted care.

lead_sponsor: Hospices Civils de Lyon

location_facility: Hospices Civils de Lyon, Hôpital E Herriot, Service de néphrologie, 5 place d'Arsonval

intervention_type: Procedure


title: A Prospective, Multicenter, Randomized, Open-label, Active Controlled, 2-parallel Group, Phase II Study to Compare Efficacy and Safety of Masitinib at 12 mg/kg/Day to Sunitinib at 50 mg/Day in Treatment of Patients With Gastro-intestinal Stromal Tumor Resistant to Imatinib

summary: The objective is to compare efficacy and safety of masitinib at 12 mg/kg/day to sunitinib at 50 mg/day in treatment of patients with gastro-intestinal stromal tumor resistant to imatinib.

ReferenceType: result

ReferenceCitation: Adenis A, Blay JY, Bui-Nguyen B, Bouché O, Bertucci F, Isambert N, Bompas E, Chaigneau L, Domont J, Ray-Coquard I, Blésius A, Van Tine BA, Bulusu VR, Dubreuil P, Mansfield CD, Acin Y, Moussy A, Hermine O, Le Cesne A. Masitinib in advanced gastrointestinal stromal tumor (GIST) after failure of imatinib: a randomized controlled open-label trial. Ann Oncol. 2014 Sep;25(9):1762-1769. doi: 10.1093/annonc/mdu237. Epub 2014 Jul 25.

family: Adenis

full_name: A. Adenis

given: A.

family: Blay

full_name: J.-Y. Blay

family: Bui-Nguyen

full_name: B. Bui-Nguyen

given: B.

family: Bouché

full_name: O. Bouché

given: O.

family: Bertucci

full_name: F. Bertucci

given: F.

family: Isambert

full_name: N. Isambert

given: N.

family: Bompas

full_name: E. Bompas

given: E.

family: Chaigneau

full_name: L. Chaigneau

given: L.

family: Domont

full_name: J. Domont

given: J.

family: Ray-Coquard

full_name: I. Ray-Coquard

given: I.

family: Blésius

full_name: A. Blésius

family: Van Tine

full_name: B.A. Van Tine

family: Bulusu

full_name: V.R. Bulusu

family: Dubreuil

full_name: P. Dubreuil

given: P.

family: Mansfield

full_name: C.D. Mansfield

family: Acin

full_name: Y. Acin

given: Y.

family: Moussy

full_name: A. Moussy

family: Hermine

full_name: O. Hermine

family: Le Cesne

full_name: A. Le Cesne

journal_name: Annals of Oncology

oa_colors: green hybrid

evidence: open (via crossref license)

license: cc-by-nc

license_normalized: cc-by-nc

title: Masitinib in advanced gastrointestinal stromal tumor (GIST) after failure of imatinib: A randomized controlled open-label trial


title: A Randomised, Double-blind, Placebo-controlled, Multi-national, Multi-centre, Phase III Study to Assess the Long Term Efficacy, Carry-over Effect and Safety of Two Dosing Regimens of 300 IR Sublingual Immunotherapy (SLIT) Administered as Allergen-based Tablets Once Daily to Patients Suffering From Grass Pollen Rhinoconjunctivitis

summary: A phase III study to evaluate Long term efficacy , carry-over effect and safety of 300 IR sublingual Immunotherapy (SLIT) tablets in adults patients suffering from grass pollen rhinoconjunctivitis

ReferenceCitation: Didier A, Worm M, Horak F, Sussman G, de Beaumont O, Le Gall M, Melac M, Malling HJ. Sustained 3-year efficacy of pre- and coseasonal 5-grass-pollen sublingual immunotherapy tablets in patients with grass pollen-induced rhinoconjunctivitis. J Allergy Clin Immunol. 2011 Sep;128(3):559-66. doi: 10.1016/j.jaci.2011.06.022. Epub 2011 Jul 29.

family: Didier

full_name: Alain Didier

given: Alain

family: Worm

full_name: Margitta Worm

given: Margitta

family: Horak

full_name: Friedrich Horak

given: Friedrich

family: Sussman

full_name: Gordon Sussman

given: Gordon

family: de Beaumont

full_name: Olivier de Beaumont

given: Olivier

family: Le Gall

full_name: Martine Le Gall

given: Martine

family: Melac

full_name: Michel Melac

given: Michel

family: Malling

full_name: Hans-Jorgen Malling

given: Hans-Jorgen

journal_name: Journal of Allergy and Clinical Immunology

publisher: Elsevier BV

publisher_dissemination: Elsevier

publisher_group: Elsevier

publisher_normalized: Elsevier

title: Sustained 3-year efficacy of pre- and coseasonal 5-grass-pollen sublingual immunotherapy tablets in patients with grass pollen–induced rhinoconjunctivitis

ReferenceCitation: Didier A, Malling HJ, Worm M, Horak F, Sussman G, Melac M, Soulié S, Zeldin RK. Post-treatment efficacy of discontinuous treatment with 300IR 5-grass pollen sublingual tablet in adults with grass pollen-induced allergic rhinoconjunctivitis. Clin Exp Allergy. 2013 May;43(5):568-77. doi: 10.1111/cea.12100.

name: Respiratory Diseases Department; Rangueil-Larrey Hospital; Toulouse; France

full_name: A. Didier

name: Allergy Clinic; Gentofte University Hospital; Copenhagen; Denmark

full_name: H.-J. Malling

name: Department of Dermatology and Allergy; Allergy Center Charité, CCM; Charité - Universitätsmedizin Berlin; Berlin; Germany

full_name: M. Worm

given: M.

name: Allergy Center Vienna West; Vienna; Austria

full_name: F. Horak

name: The University of Toronto; Toronto; ON; Canada

full_name: G. Sussman

given: G.

name: Global Clinical Development; Stallergenes S.A.; Antony; France

full_name: M. Melac

family: Soulié

full_name: S. Soulié

given: S.

family: Zeldin

full_name: R. K. Zeldin

given: R. K.

journal_name: Clinical & Experimental Allergy

publisher: Wiley

publisher_dissemination: Wiley

publisher_group: Wiley

publisher_normalized: Wiley

ReferenceCitation: Didier A, Malling HJ, Worm M, Horak F, Sussman GL. Prolonged efficacy of the 300IR 5-grass pollen tablet up to 2 years after treatment cessation, as measured by a recommended daily combined score. Clin Transl Allergy. 2015 May 22;5:12. doi: 10.1186/s13601-015-0057-8. eCollection 2015.

name: Rangueil‐Larrey HospitalDepartment of Respiratory Diseases24 Chemin de PouvourvilleTSA 30030 31059ToulouseCedex 9France

name: Allergy ClinicCopenhagen University HospitalGentofteDenmark

full_name: Hans‐Jørgen Malling

given: Hans‐Jørgen

name: <idGroup xmlns="http://www.wiley.com/namespaces/wiley"><id type="grid" value="grid.6363.0"></id><id type="isni" value="0000000122184662"></id></idGroup>Department of Dermatology and AllergyCharité – Universitätsmedizin BerlinBerlinGermany

name: <idGroup xmlns="http://www.wiley.com/namespaces/wiley"><id type="grid" value="grid.488878.3"></id></idGroup>Vienna Challenge ChamberInstitute for Allergy ResearchViennaAustria

name: <idGroup xmlns="http://www.wiley.com/namespaces/wiley"><id type="grid" value="grid.17063.33"></id><id type="isni" value="0000000121572938"></id></idGroup>Division of Allergy and Clinical ImmunologyUniversity of TorontoTorontoONCanada

repositories_institution:
PubMed Central - Europe PMC
University of Toronto - TSpace

title: Prolonged efficacy of the 300IR 5‐grass pollen tablet up to 2 years after treatment cessation, as measured by a recommended daily combined score


title: A Clinical Assessment of an Ultrasound-guided Inserted Peripheral Intravenous Catheter

acronym: ECLIPSE

summary: Evaluate the safety and efficacy of an an ultrasound-guided inserted peripheral intravenous catheter during a period of seven days.

lead_sponsor: Prodimed SAS


title: Target-controlled Infusion of Propofol and Remifentanil for Postoperative Sedation Guided by the Bispectral Index: Comparison Between Manual Perfusion and Automated Perfusion

summary: This prospective randomized study evaluates the effectiveness of a closed-loop anesthesia system during the postoperative period.

ReferenceCitation: Liu N, Chazot T, Genty A, Landais A, Restoux A, McGee K, Laloë PA, Trillat B, Barvais L, Fischler M. Titration of propofol for anesthetic induction and maintenance guided by the bispectral index: closed-loop versus manual control: a prospective, randomized, multicenter study. Anesthesiology. 2006 Apr;104(4):686-95.

lead_sponsor: Hopital Foch

location_facility: Dept of Anesthesia and Intensive Care, Hopital Pitié-Salpêtrière


title: Cohort Study of Volunteers That Have Participated to Preventive HIV-1 Vaccine Trials

summary: This cohort study should provide an exhaustive overview on long-term safety of various preventive HIV-vaccines administered in phase I and II clinical trials to healthy volunteers of the ANRS network.

lead_sponsor: ANRS, Emerging Infectious Diseases


title: Effect of the Infant Behavioral Assessment and Intervention Program (IBAIP) in Preterm Infants on Neurodevelopment at 2 Years Corrected Age

acronym: IBAIP

summary:
Mortality in very preterm infants has decreased significantly over the past twenty years. However, neuromotor, behavioral and cognitive development disorders are more common in these children born before 33 weeks of gestation as compared to term born infants.

These neurodevelopmental disorders include difficulties with self-regulation, tone, posture or poor quality movements as well as inadequate responses to sensory simulation.

Post-hospital discharge follow-up and interventionsof children born very preterm ares very heterogeneous in France. They are mainly carried out in a rehabilitation center, based on caregivers whereas IBAIP is carried out at home and family centered.

Early interventions during hospitalization or after discharge appear potentially of great interest in improving the neurodevelopemental outcome of the very preterm infants. Several early interventions have been developed and evaluated in other countries. These interventions are designed to be used early in life, mainly during the first 3 years of life, and are based on brain plasticity and intense synaptogenesis during this period of life.

The IBAIP (Infant Behavior Assessment and Intervention Program) was developed on the same theoretical foundations as the NIDCAP (Neonatal Individualized Development Care and Assessment Program). IBAIP consists of providing the child and his family with an intervention, at home, starting just before hospital discharge up to a 6 months corrected age. .The aim of IBAIP is to support developmental functions including infant's self-regulation and focus on improving the responsiveness of parents' infant interactions.

ipd_sharing: Yes

ipd_sharing_description: All collected data that underlie results in a publication

location_facility:
CHU Angers
CHU Caen
CHRU Strasbourg
CHU Tours
CHU Nantes
CHU Besançon
CHU Rennes


title: Risk-factors for Multidrug-resistant (MDR) and Extensively Drug-resistant (XDR) Bacteria Colonization Among Patients at High Risk of STIs

acronym: BMR-IST

summary: The aim of this study is to identify risk factors and prevalence of multidrug-resistant (MDR) and extensively drug-resistant (XDR) bacteria colonization among patients at high risk of STIs

time_perspective: Cross-Sectional

ReferenceCitation: Ben-Ami R, Rodríguez-Baño J, Arslan H, Pitout JD, Quentin C, Calbo ES, Azap OK, Arpin C, Pascual A, Livermore DM, Garau J, Carmeli Y. A multinational survey of risk factors for infection with extended-spectrum beta-lactamase-producing enterobacteriaceae in nonhospitalized patients. Clin Infect Dis. 2009 Sep 1;49(5):682-90. doi: 10.1086/604713.

ReferenceCitation: Cantón R, Coque TM. The CTX-M beta-lactamase pandemic. Curr Opin Microbiol. 2006 Oct;9(5):466-75. Epub 2006 Aug 30. Review.

ReferenceCitation: Coque TM, Baquero F, Canton R. Increasing prevalence of ESBL-producing Enterobacteriaceae in Europe. Euro Surveill. 2008 Nov 20;13(47). pii: 19044. Review. Erratum in: Euro Surveill. 2008 Nov 27;13(48). pii: 19051.

ReferenceCitation: Diep BA, Chambers HF, Graber CJ, Szumowski JD, Miller LG, Han LL, Chen JH, Lin F, Lin J, Phan TH, Carleton HA, McDougal LK, Tenover FC, Cohen DE, Mayer KH, Sensabaugh GF, Perdreau-Remington F. Emergence of multidrug-resistant, community-associated, methicillin-resistant Staphylococcus aureus clone USA300 in men who have sex with men. Ann Intern Med. 2008 Feb 19;148(4):249-57. Epub 2008 Jan 30.

ReferenceCitation: Gaudreau C, Pilon PA, Sylvestre JL, Boucher F, Bekal S. Multidrug-Resistant Campylobacter coli in Men Who Have Sex with Men, Quebec, Canada, 2015. Emerg Infect Dis. 2016 Sep;22(9):1661-3. doi: 10.3201/eid2209.151695.

ReferenceCitation: Harris AD, McGregor JC, Johnson JA, Strauss SM, Moore AC, Standiford HC, Hebden JN, Morris JG Jr. Risk factors for colonization with extended-spectrum beta-lactamase-producing bacteria and intensive care unit admission. Emerg Infect Dis. 2007 Aug;13(8):1144-9.

ReferenceCitation: Jean SS, Lee WS, Lam C, Hsu CW, Chen RJ, Hsueh PR. Carbapenemase-producing Gram-negative bacteria: current epidemics, antimicrobial susceptibility and treatment options. Future Microbiol. 2015;10(3):407-25. doi: 10.2217/fmb.14.135. Review. Erratum in: Future Microbiol. 2017 Apr;12 :456.

ReferenceCitation: Livermore DM, Canton R, Gniadkowski M, Nordmann P, Rossolini GM, Arlet G, Ayala J, Coque TM, Kern-Zdanowicz I, Luzzaro F, Poirel L, Woodford N. CTX-M: changing the face of ESBLs in Europe. J Antimicrob Chemother. 2007 Feb;59(2):165-74. Epub 2006 Dec 6. Review.

ReferenceCitation: Livermore DM. Has the era of untreatable infections arrived? J Antimicrob Chemother. 2009 Sep;64 Suppl 1:i29-36. doi: 10.1093/jac/dkp255. Review.

ReferenceCitation: Molina JM, Capitant C, Spire B, Pialoux G, Cotte L, Charreau I, Tremblay C, Le Gall JM, Cua E, Pasquet A, Raffi F, Pintado C, Chidiac C, Chas J, Charbonneau P, Delaugerre C, Suzan-Monti M, Loze B, Fonsart J, Peytavin G, Cheret A, Timsit J, Girard G, Lorente N, Préau M, Rooney JF, Wainberg MA, Thompson D, Rozenbaum W, Doré V, Marchand L, Simon MC, Etien N, Aboulker JP, Meyer L, Delfraissy JF; ANRS IPERGAY Study Group. On-Demand Preexposure Prophylaxis in Men at High Risk for HIV-1 Infection. N Engl J Med. 2015 Dec 3;373(23):2237-46. doi: 10.1056/NEJMoa1506273. Epub 2015 Dec 1.

family: Molina

full_name: Jean-Michel Molina

given: Jean-Michel

family: Capitant

full_name: Catherine Capitant

given: Catherine

family: Spire

full_name: Bruno Spire

given: Bruno

family: Pialoux

full_name: Gilles Pialoux

given: Gilles

family: Cotte

full_name: Laurent Cotte

given: Laurent

family: Charreau

full_name: Isabelle Charreau

given: Isabelle

family: Tremblay

full_name: Cecile Tremblay

given: Cecile

full_name: Jean-Marie Le Gall

given: Jean-Marie

family: Cua

full_name: Eric Cua

given: Eric

family: Pasquet

full_name: Armelle Pasquet

given: Armelle

family: Raffi

full_name: François Raffi

given: François

family: Pintado

full_name: Claire Pintado

given: Claire

family: Chidiac

full_name: Christian Chidiac

given: Christian

family: Chas

full_name: Julie Chas

given: Julie

family: Charbonneau

full_name: Pierre Charbonneau

given: Pierre

family: Delaugerre

full_name: Constance Delaugerre

given: Constance

family: Suzan-Monti

full_name: Marie Suzan-Monti

given: Marie

family: Loze

full_name: Benedicte Loze

given: Benedicte

family: Fonsart

full_name: Julien Fonsart

given: Julien

family: Peytavin

full_name: Gilles Peytavin

family: Cheret

full_name: Antoine Cheret

given: Antoine

ReferenceCitation: Landry MM, Sarma DP. In-situ chondrosarcoma of the foot arising in a solitary enchondroma. J Foot Surg. 1990 Jul-Aug;29(4):324-6.

ReferenceCitation: Nicolas-Chanoine MH, Gruson C, Bialek-Davenet S, Bertrand X, Thomas-Jean F, Bert F, Moyat M, Meiller E, Marcon E, Danchin N, Noussair L, Moreau R, Leflon-Guibout V. 10-Fold increase (2006-11) in the rate of healthy subjects with extended-spectrum β-lactamase-producing Escherichia coli faecal carriage in a Parisian check-up centre. J Antimicrob Chemother. 2013 Mar;68(3):562-8. doi: 10.1093/jac/dks429. Epub 2012 Nov 9.

ReferenceCitation: Osthoff M, McGuinness SL, Wagen AZ, Eisen DP. Urinary tract infections due to extended-spectrum beta-lactamase-producing Gram-negative bacteria: identification of risk factors and outcome predictors in an Australian tertiary referral hospital. Int J Infect Dis. 2015 May;34:79-83. doi: 10.1016/j.ijid.2015.03.006. Epub 2015 Mar 11.

ReferenceCitation: Rodríguez-Baño J, López-Cerero L, Navarro MD, Díaz de Alba P, Pascual A. Faecal carriage of extended-spectrum beta-lactamase-producing Escherichia coli: prevalence, risk factors and molecular epidemiology. J Antimicrob Chemother. 2008 Nov;62(5):1142-9. doi: 10.1093/jac/dkn293. Epub 2008 Jul 18.

ReferenceCitation: Ruppé E, Lixandru B, Cojocaru R, Büke C, Paramythiotou E, Angebault C, Visseaux C, Djuikoue I, Erdem E, Burduniuc O, El Mniai A, Marcel C, Perrier M, Kesteman T, Clermont O, Denamur E, Armand-Lefèvre L, Andremont A. Relative fecal abundance of extended-spectrum-β-lactamase-producing Escherichia coli strains and their occurrence in urinary tract infections in women. Antimicrob Agents Chemother. 2013 Sep;57(9):4512-7. doi: 10.1128/AAC.00238-13. Epub 2013 Jul 8.

ReferenceCitation: Schwaber MJ, Navon-Venezia S, Kaye KS, Ben-Ami R, Schwartz D, Carmeli Y. Clinical and economic impact of bacteremia with extended- spectrum-beta-lactamase-producing Enterobacteriaceae. Antimicrob Agents Chemother. 2006 Apr;50(4):1257-62.

ReferenceCitation: Szumowski JD, Wener KM, Gold HS, Wong M, Venkataraman L, Runde CA, Cohen DE, Mayer KH, Wright SB. Methicillin-resistant Staphylococcus aureus colonization, behavioral risk factors, and skin and soft-tissue infection at an ambulatory clinic serving a large population of HIV-infected men who have sex with men. Clin Infect Dis. 2009 Jul 1;49(1):118-21. doi: 10.1086/599608.

ReferenceCitation: Tumbarello M, Sanguinetti M, Montuori E, Trecarichi EM, Posteraro B, Fiori B, Citton R, D'Inzeo T, Fadda G, Cauda R, Spanu T. Predictors of mortality in patients with bloodstream infections caused by extended-spectrum-beta-lactamase-producing Enterobacteriaceae: importance of inadequate initial antimicrobial treatment. Antimicrob Agents Chemother. 2007 Jun;51(6):1987-94. Epub 2007 Mar 26. Erratum in: Antimicrob Agents Chemother. 2007 Sep;51(9):3469.

ReferenceCitation: Woerther PL, Burdet C, Chachaty E, Andremont A. Trends in human fecal carriage of extended-spectrum β-lactamases in the community: toward the globalization of CTX-M. Clin Microbiol Rev. 2013 Oct;26(4):744-58. doi: 10.1128/CMR.00023-13. Review.

ipd_sharing_description: Will be decided later by the scientific committee at the end of the study.

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


title: Safety and Efficacy of an Amino Acid Blend on Muscle and Gut Functionality in ICU Patients

summary: Assessment of the Safety and efficacy of an amino acid blend on muscle and gut functionality in Intensive Care Unit (ICU) patients.

lead_sponsor: Nestlé

intervention_type: Dietary Supplement


title: Adaptative Servoventilation Compliance in Left Ventricular Dysfunction Patients With Central Sleep Apnea: Benefit of One Month Hypnotic (Zopiclone) Versus Placebo

acronym: ZODIAC

summary: The study evaluate the effect of adaptative servoventilation (ASV) initiation combined with 14 days Zopiclone vs Placebo treatment in patients with central sleep apnea (CSA) syndrome.

ReferenceCitation: Boccon-Gibod I, Bouillet L. [Angioedema and urticaria]. Ann Dermatol Venereol. 2014 Nov;141 Suppl 3:S586-95. doi: 10.1016/S0151-9638(14)70162-0. Review. French.

ReferenceCitation: Pagnier A. [Hereditary angioedema in childhood. Diagnosis and therapeutic challenges]. Presse Med. 2015 Jan;44(1):89-95. doi: 10.1016/j.lpm.2014.07.018. Epub 2014 Dec 12. Review. French.

ReferenceCitation: Dinkel HP, Maroske J, Schrod L. Sonographic appearances of the abdominal manifestations of hereditary angioedema. Pediatr Radiol. 2001 Apr;31(4):296-8.

ReferenceCitation: Bygum A. Hereditary angio-oedema in Denmark: a nationwide survey. Br J Dermatol. 2009 Nov;161(5):1153-8. doi: 10.1111/j.1365-2133.2009.09366.x. Epub 2009 Jun 22.

ReferenceCitation: Farkas H. Pediatric hereditary angioedema due to C1-inhibitor deficiency. Allergy Asthma Clin Immunol. 2010 Jul 28;6(1):18. doi: 10.1186/1710-1492-6-18.

ReferenceCitation: El-Hachem C, Amiour M, Guillot M, Laurent J. [Hereditary angioneurotic edema: a case report in a 3-year-old child]. Arch Pediatr. 2005 Aug;12(8):1232-6. French.

ReferenceCitation: Farkas H. Management of upper airway edema caused by hereditary angioedema. Allergy Asthma Clin Immunol. 2010 Jul 28;6(1):19. doi: 10.1186/1710-1492-6-19.

ReferenceCitation: Sanchez A, Ecochard A, Maestracci M, Rodiere M. [Hereditary angioedema causing colocolic intussusception]. Arch Pediatr. 2008 Mar;15(3):271-4. doi: 10.1016/j.arcped.2007.12.004. Epub 2008 Mar 10. French.

ReferenceCitation: Pritzker HA, Levin TL, Weinberg G. Recurrent colocolic intussusception in a child with hereditary angioneurotic edema: reduction by air enema. J Pediatr Surg. 2004 Jul;39(7):1144-6.

ReferenceCitation: Parisi G, Chiarelli A, Squadrone NP, Galante E. Hereditary angioedema, a rare cause of recurrent abdominal pain. A report of 2 clinical cases and comments of a general nature Allergy Asthma Proc. 2013 Jul-Aug;34(4):312-27

ReferenceCitation: MacGinnitie AJ. Pediatric hereditary angioedema. Pediatr Allergy Immunol. 2014 Aug;25(5):420-7. doi: 10.1111/pai.12168. Epub 2013 Dec 9. Review.

ReferenceCitation: Deroux A, Vilgrain I, Dumestre-Pérard C, Boccon-Gibod I, Bouillet L. Towards a specific marker for acute bradykinin-mediated angioedema attacks: a literature review. Eur J Dermatol. 2015 Jul-Aug;25(4):290-5. doi: 10.1684/ejd.2015.2547. Review.

ReferenceCitation: Nussberger J, Cugno M, Cicardi M. Bradykinin-mediated angioedema. N Engl J Med. 2002 Aug 22;347(8):621-2.

ReferenceCitation: Cugno M, Zanichelli A, Bellatorre AG, Griffini S, Cicardi M. Plasma biomarkers of acute attacks in patients with angioedema due to C1-inhibitor deficiency. Allergy. 2009 Feb;64(2):254-7. doi: 10.1111/j.1398-9995.2008.01859.x. Epub 2008 Dec 4.

ReferenceCitation: Hogan AD, Schwartz LB. Markers of mast cell degranulation. Methods. 1997 Sep;13(1):43-52.

ReferenceCitation: Brickman CM, Frank MM, Kaliner M. Urine-histamine levels in patients with hereditary angioedema (HAE). J Allergy Clin Immunol. 1988 Sep;82(3 Pt 1):403-6.

ReferenceCitation: Payne V, Kam PC. Mast cell tryptase: a review of its physiology and clinical significance. Anaesthesia. 2004 Jul;59(7):695-703. Review.

ReferenceCitation: Kasperska-Zając A, Grzanka A, Czecior E, Misiolek M, Rogala B, Machura E. Acute phase inflammatory markers in patients with non-steroidal anti-inflammatory drugs (NSAIDs)-induced acute urticaria/angioedema and after aspirin challenge. J Eur Acad Dermatol Venereol. 2013 Aug;27(8):1048-52. doi: 10.1111/j.1468-3083.2012.04486.x. Epub 2012 Feb 21.

ReferenceCitation: Fujii K, Konishi K, Kanno Y, Ohgou N. Acute urticaria with elevated circulating interleukin-6 is resistant to anti-histamine treatment. J Dermatol. 2001 May;28(5):248-50.

ReferenceCitation: Kasperska-Zajac A, Brzoza Z. Increased D-dimer concentration in plasma of patients with severe acute urticaria. Br J Dermatol. 2009 Dec;161(6):1409-10. doi: 10.1111/j.1365-2133.2009.09466.x. Epub 2009 Sep 15.

ReferenceCitation: Brevet: w/o 2008 062314 circulating ve-cadherin as a predictive marker of sensitivity or resistance to anti-tumoral treatment, and improved method for the detection of soluble proteins.

ReferenceCitation: Bouillet L, Sidibé A, Polena H, Mannic T, Deroux A, Stidder B, Vittecoq O, Vilgrain I. [Endothelial junctions: exploiting their instability in the development of biomarkers for vascular remodelling]. Med Sci (Paris). 2014 Jun-Jul;30(6-7):633-5. doi: 10.1051/medsci/20143006012. Epub 2014 Jul 11. French.

ReferenceCitation: Bouillet L, Vilgrain I. VE-cadherin, a potential marker for endothelial cell activation during hereditary angioedema attacks. J Allergy Clin Immunol. 2014 Jul;134(1):241. doi: 10.1016/j.jaci.2014.04.016. Epub 2014 May 27.

ReferenceCitation: Sidibé A, Polena H, Pernet-Gallay K, Razanajatovo J, Mannic T, Chaumontel N, Bama S, Maréchal I, Huber P, Gulino-Debrac D, Bouillet L, Vilgrain I. VE-cadherin Y685F knock-in mouse is sensitive to vascular permeability in recurrent angiogenic organs. Am J Physiol Heart Circ Physiol. 2014 Aug 1;307(3):H455-63. doi: 10.1152/ajpheart.00774.2013. Epub 2014 May 23.

ReferenceCitation: Sidibé A, Polena H, Razanajatovo J, Mannic T, Chaumontel N, Bama S, Maréchal I, Huber P, Gulino-Debrac D, Bouillet L, Vilgrain I. Dynamic phosphorylation of VE-cadherin Y685 throughout mouse estrous cycle in ovary and uterus. Am J Physiol Heart Circ Physiol. 2014 Aug 1;307(3):H448-54. doi: 10.1152/ajpheart.00773.2013. Epub 2014 May 23.

ReferenceCitation: Bouillet L, Mannic T, Arboleas M, Subileau M, Massot C, Drouet C, Huber P, Vilgrain I. Hereditary angioedema: key role for kallikrein and bradykinin in vascular endothelial-cadherin cleavage and edema formation. J Allergy Clin Immunol. 2011 Jul;128(1):232-4. doi: 10.1016/j.jaci.2011.02.017. Epub 2011 Mar 24.

ReferenceCitation: Suffritti C, Zanichelli A, Maggioni L, Bonanni E, Cugno M, Cicardi M. High-molecular-weight kininogen cleavage correlates with disease states in the bradykinin-mediated angioedema due to hereditary C1-inhibitor deficiency. Clin Exp Allergy. 2014 Dec;44(12):1503-14. doi: 10.1111/cea.12293.

ReferenceCitation: Kahn R, Herwald H, Müller-Esterl W, Schmitt R, Sjögren AC, Truedsson L, Karpman D. Contact-system activation in children with vasculitis. Lancet. 2002 Aug 17;360(9332):535-41.

ReferenceCitation: Ghannam A, Sellier P, Defendi F, Favier B, Charignon D, López-Lera A, López-Trascasa M, Ponard D, Drouet C. C1 inhibitor function using contact-phase proteases as target: evaluation of an innovative assay. Allergy. 2015 Sep;70(9):1103-11. doi: 10.1111/all.12657. Epub 2015 Jun 9.

ReferenceCitation: Adam SS, Key NS, Greenberg CS. D-dimer antigen: current concepts and future prospects. Blood. 2009 Mar 26;113(13):2878-87. doi: 10.1182/blood-2008-06-165845. Epub 2008 Nov 13. Review.

ReferenceCitation: Blohmé G. Treatment of hereditary angioneurotic oedema with tranexamic acid. A random double-blind cross-over study. Acta Med Scand. 1972 Oct;192(4):293-8.

ReferenceCitation: Brown NJ, Gainer JV, Stein CM, Vaughan DE. Bradykinin stimulates tissue plasminogen activator release in human vasculature. Hypertension. 1999 Jun;33(6):1431-5.

ReferenceCitation: Cugno M, Hack CE, de Boer JP, Eerenberg AJ, Agostoni A, Cicardi M. Generation of plasmin during acute attacks of hereditary angioedema. J Lab Clin Med. 1993 Jan;121(1):38-43.

ReferenceCitation: Frank MM, Sergent JS, Kane MA, Alling DW. Epsilon aminocaproic acid therapy of hereditary angioneurotic edema. A double-blind study. N Engl J Med. 1972 Apr 13;286(15):808-12.

ReferenceCitation: Joseph K, Tholanikunnel BG, Wolf B, Bork K, Kaplan AP. Deficiency of plasminogen activator inhibitor 2 in plasma of patients with hereditary angioedema with normal C1 inhibitor levels. J Allergy Clin Immunol. 2016 Jun;137(6):1822-1829.e1. doi: 10.1016/j.jaci.2015.07.041. Epub 2015 Sep 26.

ReferenceCitation: Kaplan AP, Austen KF. A prealbumin activator of prekallikrein. II. Derivation of activators of prekallikrein from active Hageman factor by digestion with plasmin. J Exp Med. 1971 Apr 1;133(4):696-712.

ReferenceCitation: Kleniewski J, Blankenship DT, Cardin AD, Donaldson V. Mechanism of enhanced kinin release from high molecular weight kininogen by plasma kallikrein after its exposure to plasmin. J Lab Clin Med. 1992 Jul;120(1):129-39.

ReferenceCitation: Kluft C, Trumpi-Kalshoven MM, Jie AF, Veldhuyzen-Stolk EC. Factor XII-dependent fibrinolysis: a double function of plasma kallikrein and the occurrence of a previously undescribed factor XII- and kallikrein-dependent plasminogen proactivator. Thromb Haemost. 1979 Jun 30;41(4):756-73.

ReferenceCitation: Nielsen EW, Johansen HT, Høgåsen K, Wuillemin W, Hack CE, Mollnes TE. Activation of the complement, coagulation, fibrinolytic and kallikrein-kinin systems during attacks of hereditary angioedema. Scand J Immunol. 1996 Aug;44(2):185-92.

ReferenceCitation: Reshef A, Zanichelli A, Longhurst H, Relan A, Hack CE. Elevated D-dimers in attacks of hereditary angioedema are not associated with increased thrombotic risk. Allergy. 2015 May;70(5):506-13. doi: 10.1111/all.12587. Epub 2015 Feb 23.

lead_sponsor: University Hospital, Grenoble

location_facility: Clinique de Physiologie Sommeil et Exercice, Pole Thorax et Vaisseaux , University Hospital Grenoble Alpes


title: Physical Exercise and Neuromuscular Diseases: Pilot Study of an Innovative Physiotherapy in Patients With Infantile Spinal Muscular Atrophy

acronym: ExerASI

summary:
This clinical trial aims to test a new physio-therapeutic approach tailored to type 2 and 3 Spinal Muscular Atrophy patients, based on physical training in swimming-pool. This specific exercise should promote motor skills of trained patients, as we have observed in different mouse models. Patient's motor skills will be assessed using different scales including MFM and Hammersmith.

This clinical trial attempts to develop a new non-invasive motor scale with sophisticated instruments.

This scale will be useful in future clinical trials on SMA, given the lack of sensitivity of currently available scales.

In addition, the study attempts to validate a questionnaire on post-exercise physical well-being.


title: The Impact of Systematic Psychological and Medical Care for Treatment of Pediatric Patients With SCD: : A Luxury or a Necessity?

acronym: Drépano

summary: Sickle cell disease (SCD), a genetically transmitted blood disease, necessitates life-long care. In children, the disease may cause intense pain and other severe complications. Studies show that sources of stress, as well as complex psychological and intercultural issues associated with SCD, often aggravate symptoms. At Louis Mourier hospital, the treatment model used is systematic psychological and medical care. Our hypothesis is that this care is beneficial for both the children and their families as seen in improved quality of life and positive impact on medical symptoms.

time_perspective: Retrospective

lead_sponsor: Fondation Ophtalmologique Adolphe de Rothschild


title: Impact of Oral Controlled Release Flecainide Acetate Capsules on Health-Related QoL in Patients With Paroxysmal Atrial Fibrillation

summary: The purpose of this study is to evaluate the management of paroxysmal atrial fibrillation with controlled release flecainide on patient's quality of life.

lead_sponsor: MEDA Pharma GmbH & Co. KG

location_facility: Hopital Cardiologique, Service de Cardiologique CHR de Lille


title: Identification of Biomarkers Predictive of Worse Prognosis in Henoch Schonlein Purpura

summary:
Henoch Schonlein Purpura (HSP), vasculitis of small vessels with deposits of IgA, is considered by many authors as the systemic form of Berger's disease (IgA-N). IgA-N is characterized by IgA1 deposits in mesangial areas associated with mesangial proliferation. These two diseases remain the leading cause of ESRD by primitive glomerulopathy in Western countries. In recent years, considerable progress has been made in understanding the pathophysiological mechanisms of IgA-N. However, only a high rate of proteinuria at one year or the presence of severe glomerular inflammation on renal biopsy remain predictors of long term renal function. Moreover, the high variability of HSP clinical expression, from few purpura skin lesions that evolve favourably spontaneously, to rapidly progressive renal failure, remains so far unexplained but suggests the existence of individual genetic susceptibility.

In the first part of the study, we will study key factors based on physiopathological data obtained by our laboratory as well as by other groups. The second part of the study concerns genetic factors. Although the candidate genes that may confer a particular susceptibility to the disease, to progress to ESRD or respond to treatment are many, the genes involved in inflammation or controlling renin-angiotensin system are of particular interest.

We will apply these results by studying patients with HSP showing three distinct phenotypes (HSP with isolated cutaneous purpura or associated with minimal or severe renal disease) at diagnosis and after clinical remission.

The purpose of this study is to assess whether the phenotype at diagnosis is associated with the physiological markers and if one of them predicts a pejorative evolution of renal disease at 1 year. Meanwhile, study of polymorphism of selected genes of interest could allow identification of patients with specific genetic susceptibility or with bad prognosis factors who would be thus eligible for specific treatment.


title: Prospective Randomized Controlled Single Blind Study of Efficacy and Tolerance of AVAPS Mode Compared to Bilevel Pressure Ventilation un Adult Patients With Myotonic Dystrophy

summary: Myotonic dystrophy type 1 is a myopathy with complex respiratory pattern and at risk to develop respiratory failure. Classical mode of ventilation are sometimes not tolerated or ineffective in this population. New modes of nocturnal ventilation by combining both volumetric and barometric advantages. The aim of this study is to compare effect of AVAPS mode to bilevel pressure support.

location_facility: Home ventilation Unit , Raymond Poincaré hospital


title: Efficacy of Infiltration of Chlorhydrate of Ropivacaine in the Prevention of Chronic Breast Pain After Surgery for Breast Cancer.

summary: The aim of the study is to evaluate the effect of local anesthetic (chlorhydrate of ropivacaine) to prevent chronic pain after breast surgery for cancer.

lead_sponsor: Institut Curie


title: Describing, Detecting and Orienting Adults Without Intellectual Disability Asking for an Autism Spectrum Disorder Diagnosis

acronym: ASSORT

summary: The investigators aim at offering to about 80 patients a diagnostic assessment for Autism Spectrum Disorder (ASD), and at testing the feasibility of this protocol to detect and diagnose ASD in adults without intellectual disability.

status: Recruiting

lead_sponsor: Hôpital le Vinatier


title: Prospective Study of Total Knee Replacement With the ROCC Knee

summary: The purpose of this study was to assess the results of a Total Knee prosthesis specifically intended to enhance functional performance , especially in terms of physical and sports activity.

lead_sponsor: Bercovy, Michel, M.D.


title: In Utero Treatment of Cytomegalovirus congénitale Infection With Valacyclovir : Prospective Multicenter Nonrandomized Trial

summary: The infection with cytomegalovirus (CMV) is the first cause of congenital neurological handicap of infectious origin. It is probable that the néonatale viral load is correlated with becoming of infected new-born babies. Among the active antiviral treatments against CMV, valacyclovir is the only whose fœtal and maternal tolerance was evaluated during the pregnancy. Its harmlessness and its aptitude to decrease the CMV viral load justify to evaluate it in a study. Decrease the fœtal viral load could make possible to decrease symptomatology néonatale in a group of infected fœtuses.

ReferenceCitation: Faure-Bardon V, Magny JF, Parodi M, Couderc S, Garcia P, Maillotte AM, Benard M, Pinquier D, Astruc D, Patural H, Pladys P, Parat S, Guillois B, Garenne A, Bussières L, Guilleminot T, Stirnemann J, Ghout I, Ville Y, Leruez-Ville M. Sequelae of Congenital Cytomegalovirus Following Maternal Primary Infections Are Limited to Those Acquired in the First Trimester of Pregnancy. Clin Infect Dis. 2019 Oct 15;69(9):1526-1532. doi: 10.1093/cid/ciy1128.

name: Equipe d’Accueil, Paris Descartes University, Sorbonne Paris CitéArchet, France

name: Maternity, Hospital Necker-E.M, Paris, France

family: Faure-Bardon

full_name: Valentine Faure-Bardon

given: Valentine

name: Neonatal Intensive Care Unit, Hospital Necker-E.M, France

family: Magny

full_name: Jean-François Magny

given: Jean-François

name: Otology Department, Assistance Publique de Paris, Hospital Necker-E.M, France

family: Parodi

full_name: Marine Parodi

given: Marine

name: Maternity, Hospital Intercommunal Poissy-Saint Germain, Marseille, France

family: Couderc

full_name: Sophie Couderc

given: Sophie

name: Neonatology and Intensive Care Department, Assistance Publique de Marseille, Hospital La Conception, Marseille, France

family: Garcia

full_name: Patricia Garcia

given: Patricia

name: Neonatal Intensive Care Unit, Centre Hospitalier Universitaire Nice, Hospital L’Archet, Marseille, France

family: Maillotte

full_name: Anne-Marie Maillotte

given: Anne-Marie

name: Department of Neonatalogy, Toulouse University Hospital, Saint-Etienne, France

family: Benard

full_name: Melinda Benard

given: Melinda

name: Department of Neonatalogy, Rouen University Hospital, Saint-Etienne, France

family: Pinquier

full_name: Didier Pinquier

given: Didier

name: Department of Neonatalogy, Strasbourg University Hospital, Saint-Etienne, France

family: Astruc

full_name: Dominique Astruc

given: Dominique

name: Neonatal Intensive Care Unit, University Hospital, Saint-Etienne, France

family: Patural

full_name: Hugues Patural

given: Hugues

name: Pediatric Department, Neonatology, Centre Hospitalier Universitaire Rennes and Centre d’Investigation Clinique, France

family: Pladys

full_name: Patrick Pladys

given: Patrick

name: Maternity, Assistance Publique Hopitaux de Paris (AP-HP), Hospital Cochin, France

family: Parat

full_name: Sophie Parat

name: Department of Neonatalogy, Centre Hospitalier Universitaire de Caen, France

name: Medical School, Université Caen Normandie, France

family: Guillois

full_name: Bernard Guillois

given: Bernard

name: Brest, Neonatal and Pediatric Intensive Care Unit, Centre Hospitalier Régional Universitaire, France

family: Garenne

full_name: Armelle Garenne

name: Clinical Research Unit, AP-HP, Hospital Necker-E.M., France

family: Bussières

full_name: Laurence Bussières

given: Laurence

name: Virology Laboratory, Reference Laboratory for Cytomegalovirus Infections, AP-HP, Hospital Necker-E.M., France

family: Guilleminot

full_name: Tiffany Guilleminot

given: Tiffany

family: Stirnemann

full_name: Julien Stirnemann

name: Unité de Recherche Clinique et Département de Santé Publique, AP-HP, Hôpital Ambroise Paré, Boulogne, France

name: University Versaille-Saint-Quentin, Unité Mixte de recherche S, Université Versailles St-Quentin-en-Yvelines, Montigny, France

family: Ghout

full_name: Idir Ghout

given: Idir

family: Ville

full_name: Yves Ville

given: Yves

family: Leruez-Ville

full_name: Marianne Leruez-Ville

given: Marianne

journal_name: Clinical Infectious Diseases

publisher: Oxford University Press (OUP)

publisher_dissemination: Oxford University Press

publisher_group: Oxford University Press

publisher_normalized: Oxford University Press


title: Investigation of the Safety, Tolerability and Pharmacodynamic Effects of Sublingual Immunotherapy Tablets of House Dust Mite Allergen Extracts in Adults With House Dust Mite-associated Allergic Asthma

summary: The purpose of this study is to investigate the safety of different doses of sublingual tablets of house dust mite allergen extracts in adults with house dust mite-associated allergic asthma.

lead_sponsor: Stallergenes Greer

intervention_type: Biological


title: Safety and Performance of Miami InnFocus Drainage Implant (MIDI Arrow) to Relieve Glaucoma Symptoms

summary: To assess the safety and performance of the MIDI Arrow in patients suffering from glaucoma that is inadequately controlled on maximum tolerated medical therapy with intraocular pressure ≥ 18 mm Hg and ≤ 40 mm Hg

lead_sponsor: InnFocus Inc.

location_facility: Clinique Mutualiste - Pavillon Ophtalmogique


title: Adipose Tissue Involvement in Alcohol-induced Liver Inflammation in Human : Study of Pro- and Anti-inflammatory Cytokines and ADIPOKINES..

acronym: RIHTA

summary:
The histological characteristics of alcoholic liver disease (ALD) and non-alcoholic steatohepatitis (NASH) related to overweight and obesity suggest the presence of partly common physiopathological mechanisms. We reported that the ponderal overload was an independent risk factor of alcoholic cirrhosis. The adipose tissue was considered for a long time as a simple place of storage of fat. However, it is now recognized that the adipose tissue can secrete cytokines called ADIPOKINES.

The adipose tissue can secrete others cytokines such as TNF-alpha, IL6, IL10 and IL1-Ra. Increase in the production of the leptin and TNF-alpha by the adipose tissue after alcohol administration in the rat, as well as the role of leptin in inflammation and liver fibrogenesis in the murine model of chemical hepatotoxicity strongly suggest that activation of adipocytes by alcohol can explain the strong correlation observed between the body mass index (BMI) and the severity of ethanol-induced liver injury. Conversely, it was suggested in a murine model that the reduction in adiponectin production would sensitize the liver with the toxicity of alcohol. The PPAR alpha and gamma are the receptors which play a role both in inflammation and glucide and lipid metabolism. Taking into account the inhibiting role of PPAR alpha on the proliferation of the hepatic stellate cells, responsible for the fibrosis, the PPAR could also be implied in the relation between the overweight and the hepatic fibrosis in the alcoholic.

primary_purpose: Basic Science

ReferenceCitation: Voican CS, Njiké-Nakseu M, Boujedidi H, Barri-Ova N, Bouchet-Delbos L, Agostini H, Maitre S, Prévot S, Cassard-Doulcier AM, Naveau S, Perlemuter G. Alcohol withdrawal alleviates adipose tissue inflammation in patients with alcoholic liver disease. Liver Int. 2015 Mar;35(3):967-78. doi: 10.1111/liv.12575. Epub 2014 Jun 3.

name: INSERM U996; IPSIT; Clamart F-92140 France

name: Univ Paris-Sud; Faculté de médecine Paris-Sud; Kremlin-Bicêtre F-94270 France

name: AP-HP; Hôpital Antoine Béclère; Service d'hépato-gastroentérologie et nutrition; Clamart F-92140 France

family: Voican

full_name: Cosmin S. Voican

given: Cosmin S.

family: Njiké-Nakseu

full_name: Micheline Njiké-Nakseu

given: Micheline

family: Boujedidi

full_name: Hédia Boujedidi

given: Hédia

family: Barri-Ova

full_name: Nadège Barri-Ova

given: Nadège

family: Bouchet-Delbos

full_name: Laurence Bouchet-Delbos

name: AP-HP; Hôpital Bicêtre; Unité de recherche clinique Paris-Sud; Kremlin-Bicêtre F-94270 France

family: Agostini

full_name: Hélène Agostini

given: Hélène

name: AP-HP; Hôpital Antoine Béclère; Service de radiologie; Clamart F-92140 France

family: Maitre

full_name: Sophie Maitre

name: AP-HP; Hôpital Antoine Béclère; Service d'anatomie pathologique; Clamart F-92140 France

family: Prévot

full_name: Sophie Prévot

family: Cassard-Doulcier

full_name: Anne-Marie Cassard-Doulcier

family: Naveau

full_name: Sylvie Naveau

given: Sylvie

family: Perlemuter

full_name: Gabriel Perlemuter

given: Gabriel

journal_name: Liver International


title: Diagnostic Performance of 18F-FDG-PET and Diffusion-weighted MRI in the Assessment of Stage IB to IIB2 Cervical Squamous-cell Carcinoma Response to Concomitant Radiochemotherapy and Brachytherapy

acronym: ERRICC

summary:
Rationale: The benefit-risk ratio of surgery following concomitant radiochemotherapy and brachytherapy remains to be defined in cervical squamous-cell carcinoma (SCC) treatment. Scarce studies evaluated the interest of 18F-FDG-PET and MRI in the assessment of response to treatment before surgery. A positive predictive value of 75% was found in a small study making 18F-FDG-PET a promising tool to assess tumor response and guide surgical approach. Diffusion-weighted MRI was also described as an early and sensitive indicator in other diseases.

Objectives: The main objective of this study is to evaluate the sensitivity of 18F-FDG-PET in the assessment of cervical cancer response to radiochemotherapy and brachytherapy. Secondary objectives focus on 18F-FDG-PET specificity and likehood ratios as well as diffusion-weighted MRI diagnostic performances.

Method: We will conduct a prospective cohort study of 148 women with a stage IB to IIB2 cervical SCC recruited over 2.5 years in 24 centers in France. Each patient will undergo a 18F-FDG-PET and a diffusion-weighted MRI before surgery and 8 weeks after completion of the brachytherapy. The total follow-up duration (study participation) of patients will be 11 weeks : inclusion after completion of radiochemotherapy and brachytherapy, 8 weeks until 18F-FDG-PET and diffusion-weighted MRI, and 3 weeks until surgery.

Expected results: 18F-FDG-PET and diffusion-weighted MRI could constitute a reliable tool to assess response to radiochemotherapy and brachytherapy in cervical SCC treatment. If so it could improve clinical practices and be helpful to decide whether the patient needs surgery or not after radiochemotherapy and brachytherapy.

location_facility: Service de Gynécologie, Hôpital Archet II

location_facility: Service de Chirurgie Oncologique, Centre de Lutte Contre le Cancer Georges-François Leclerc

location_facility: Département des Radiations, Centre Eugène Marquis

location_facility: Service de Gynécologie Obstétrique, Hôpital de la Croix-Rousse, Hospices Civils de Lyon

location_facility: Service de Gynécologie, Hôpital Européen Georges Pompidou, APHP

location_facility: Service de Chirurgie, Centre Henri Becquerel

location_facility: Service de Gynécologie Obstétrique, CHU la Milétrie

location_facility: Département de Radiothérapie, Institut de Cancérologie de la Loire

location_facility: Service de Chirurgie Gynécologique, Hôpital Arnaud de Villeneuve

location_facility: Service de Gynécologie Obstétrique, Hôpital Tenon, APHP

location_facility: Service de Chirurgie Gynécologique, Institut Curie - Hôpital René Huguenin

location_facility: Service Gynécologie Obstétrique, Hôpital Pellegrin, CHU Bordeaux

location_facility: Service de Radiothérapie, C.R.L.C. Val d'Aurelle

location_facility: Service de Gynécologie Obstétrique, Hôpital Nord

location_facility: Service de Médecine Nucléaire, Institut de cancérologie de l'Ouest - Site Paul Papin

location_facility: Servce de Médecine Nucléaire, Centre René Gauducheau, CRLCC Nantes Atlantique

location_facility: Service de Gynécologie Obstétrique, CHU St-Etienne

location_facility: Service de Gynécologie, Hôpital Femme Mère Enfant, Hospices Civils de Lyon

location_facility: Service de Gynécologie Obstétrique, CHU Anne de Bretagne Hôpital Sud

location_facility: Service de Chirurgie Oncologique, Institut de Cancérologie de Lorraine

location_facility: Service de Gynécologie Obstétrique, Centre Hospitalier Lyon Sud, Hospices Civils de Lyon

location_facility: Service de Médecine Nucléaire, Hôpital Brabois


title: A Prospective, Randomised, Multi-centre, Blind-observer, Controlled, Parallel-group Study Comparing the Efficacy and Safety of DERMAGEN® Versus Conventional Treatment in the Treatment of Diabetic Neuropathic Foot Ulcer

acronym: DERMAGEN®

summary:
It is estimated that 300 million people worldwide will have diabetes by the year 2025. About 12 percent of those with diabetes will have had a foot ulcer, which is a major source of morbidity, concern, and cost.

The foot ulcers are the leading cause of hospitalization among people with diabetes and often lead to amputation. The costs of treatment and the high morbidity and mortality associated with diabetic foot problems necessitate the need for a systemic approach to a foot ulcer management.

Current local treatments of this type of ulcer are: dressings (hydrocolloids, alginate…), and growth factors. However modern dressings may not avoid infection and the results of the clinical studies are not significant in terms of complete healing rate or in terms of time to healing. Concerning growth factors, the only one whose therapeutic application made proof is the rhPDGF (Regranex®) with an increase in the number of ulcers completely healed at the twentieth week compared to placebo (50% and 35%, respectively).

The advancement of tissue-engineering has made possible dermal replacement on human wounds to facilitate healing.

A new sponge composed of collagen and glycosaminoglycans (chondroitins 4 and 6 sulphate), reticulated by ionic bonds with chitosan before freeze-drying, was developed in France. This sponge is a non-toxic product due to its non-chemical reticulation (ionic bonds), biocompatible and biodegradable processes, handling and storable easily.

The objective of this study is to demonstrate that such a substitute, cellularized by functional allogenic fibroblasts, and complying with all safety conditions, enables to lead to healing of diabetic foot ulcers.

lead_sponsor: Laboratoires Genévrier


title: Randomized Double Blind Trial Comparing the Efficacy of Prazosin Versus Placebo Associated With Peg-Interferon Alpha 2b and Ribavirin for Initial Treatment of Patients With Hepatitis C With Genotype 1 or 4 and Severe Fibrosis

summary: Viral hepatitis C prognosis is related to the presence of a fibrosis and to the risk of developing cirrhosis or hepatic cancer. The study will evaluate the efficacy of prazosin to make hepatic fibrosis regress, in patients with chronic hepatitis C and severe fibrosis.

lead_sponsor: French National Agency for Research on AIDS and Viral Hepatitis


title: A Prospective, Multicentric Clinical Proof-of-concept Study to Stratify Targeted Therapies Adapted to Molecular Profiling of Relapsed or Refractory Pediatric Tumors

acronym: MAPPYACTS

summary:
In the light of the development of high-throughput technologies enabling a biology-based reclassification of tumors and the increasing number of available specifically targeting anticancer agents the era of "precision medicine" has begun. Several clinical precision medicine trials with the aim of stratifying treatment according to molecular profiles (for example in France: 'MOlecular Screening for CAncer Treatment Optimization' MOSCATO-01, SHIVA, PROFILER, Safir01, Safir02) are ongoing in adults and have shown the feasibility of this approach. MOSCATO-01 is the first trial worldwide including pediatric patients, performing an on-purpose intervention and molecular profiling in recurrent tumors. Together with more than 500 adult patients, between December 2012 to August 2014, the tumors of 35 children and adolescents have been profiled, confirming that this approach is feasible in pediatric patients albeit with accelerated time stringencies. Importantly, the results of the first children and adolescents profiled showed that 2/3 of patients had 'actionable' alterations using hot spot mutations sequencing and CGH array (Geoerger B et al, ASCO 2014).

The project 'MAPPYACTS' will use both Whole Exome Sequencing (WES) and RNA Sequencing of tumor tissue to increase the number of targetable genomic alterations. Furthermore to improve understanding of the overall molecular profile and possible response to treatment, methylation array, miRNA expression profiles, and study of immunomodulators will be performed on tumor samples subsequently. CLIP2 (INCa-labeled early phase clinical trials centers) - SiRIC (INCa- labeled comprehensive cancer centers) molecular profiling and bioinformatics platforms will contribute with their expertise in molecular profiling projects and characterization of pediatric cancers. Data interpretation of molecular genetic alterations detected by WES and RNA Seq and treatment recommendation will be done within a multidisciplinary therapeutic molecular biology tumor board.

'MAPPYACTS' will produce one of the largest cohorts of molecularly characterized relapsed tumors reported to date, and thanks to increased access to clinical trials since the European pediatric legislation, the investigators expect that 20-30% of patients can be stratified into a targeted trial based on the detected profile.

It is the investigators' intention that this initiative paves the way to enrich ongoing clinical targeted agent trials, to increase the numbers of stratified clinical trials, to an earlier access to targeted agents, and will play a crucial role in the relevant development of these new agents in pediatric malignancies.

primary_purpose: Screening

ReferenceCitation: Morscher RJ, Brard C, Berlanga P, Marshall LV, André N, Rubino J, Aerts I, De Carli E, Corradini N, Nebchi S, Paoletti X, Mortimer P, Lacroix L, Pierron G, Schleiermacher G, Vassal G, Geoerger B. First-in-child phase I/II study of the dual mTORC1/2 inhibitor vistusertib (AZD2014) as monotherapy and in combination with topotecan-temozolomide in children with advanced malignancies: arms E and F of the AcSé-ESMART trial. Eur J Cancer. 2021 Nov;157:268-277. doi: 10.1016/j.ejca.2021.08.010. Epub 2021 Sep 17.

family: Morscher

full_name: Raphael J. Morscher

given: Raphael J.

family: Brard

full_name: Caroline Brard

given: Caroline

family: Berlanga

full_name: Pablo Berlanga

given: Pablo

family: Marshall

full_name: Lynley V. Marshall

given: Lynley V.

family: André

full_name: Nicolas André

given: Nicolas

family: Rubino

full_name: Jonathan Rubino

given: Jonathan

family: Aerts

full_name: Isabelle Aerts

given: Isabelle

family: De Carli

full_name: Emilie De Carli

given: Emilie

family: Corradini

full_name: Nadège Corradini

family: Nebchi

full_name: Souad Nebchi

given: Souad

family: Paoletti

full_name: Xavier Paoletti

given: Xavier

family: Mortimer

full_name: Peter Mortimer

given: Peter

family: Lacroix

full_name: Ludovic Lacroix

given: Ludovic

family: Pierron

full_name: Gaelle Pierron

given: Gaelle

family: Schleiermacher

full_name: Gudrun Schleiermacher

given: Gudrun

family: Vassal

full_name: Gilles Vassal

given: Gilles

family: Geoerger

full_name: Birgit Geoerger

given: Birgit

journal_name: European Journal of Cancer

ReferenceCitation: Peneder P, Stütz AM, Surdez D, Krumbholz M, Semper S, Chicard M, Sheffield NC, Pierron G, Lapouble E, Tötzl M, Ergüner B, Barreca D, Rendeiro AF, Agaimy A, Boztug H, Engstler G, Dworzak M, Bernkopf M, Taschner-Mandl S, Ambros IM, Myklebost O, Marec-Bérard P, Burchill SA, Brennan B, Strauss SJ, Whelan J, Schleiermacher G, Schaefer C, Dirksen U, Hutter C, Boye K, Ambros PF, Delattre O, Metzler M, Bock C, Tomazou EM. Multimodal analysis of cell-free DNA whole-genome sequencing for pediatric cancers with low mutational burden. Nat Commun. 2021 May 28;12(1):3230. doi: 10.1038/s41467-021-23445-w.

family: Peneder

full_name: Peter Peneder

family: Stütz

full_name: Adrian M. Stütz

given: Adrian M.

family: Surdez

full_name: Didier Surdez

given: Didier

family: Krumbholz

repository_institution: University of Leeds, The University of Sheffield, University of York - White Rose Research Online

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

repository_institution: University College London - UCL Discovery

repositories:
PubMed Central
UCL Discovery
eprints.whiterose.ac.uk

lead_sponsor: Gustave Roussy, Cancer Campus, Grand Paris

location_facility:
Hospital Universitari Vall D'Hebron
Schneider Children's Medical Center
Our Lady's Children's Hospital
Fondazione IRCCS Istituto
Gustave Roussy


title: Observational Study on CML Patients in Any Phase of the Disease Treated With Ponatinib (Iclusig®): A Multicentre, Ambispective Cohort Study

summary: This is a multicentre ambispective cohort study involving French patients who have started or are receiving for less than 6 months a treatment with ponatinib. This study aims at better qualifying the ponatinib benefit-risk balance in real life and in relation with CML patients' therapeutic history.

status: Active, not recruiting

time_perspective: Other

lead_sponsor: Incyte BioSciences France

location_facility: Hopitaux Prives Metz Centre De Belle-Isle

location_facility: Institut Universitaire Du Cancer Toulouse - Oncopo

location_facility: CH De Metz (Hopital De Mercy - CHR Metz Thionville)

location_facility: Cabinet D'hematologie De La Clinique Du Parc


title: Highly Sensitive Serum Cardiac Troponin T and Cardiovascular Events in Patients With Systemic Lupus Erythematosus

acronym: TROPOPLUS

summary: Identification of biological markers able to better stratify cardiovascular risks in systemic lupus erythematosus patients is needed. We aimed to determine whether serum cardiac troponin T levels measured with a highly sensitive assay (HS-cTnT) may predict cardiovascular events in systemic lupus erythematosus.

lead_sponsor: Assistance Publique - Hôpitaux de Paris


title: Acoustic Structures Crying of Infants From 1 to 4 Months and Their Signification

acronym: LongCRY

summary:
Crying is a survival mechanism for babies and their almost exclusive means of expression until the age of 4 months. Babies 'cry is mostly related to pain, a feeling of hunger, discomfort or separation following the departure of a parent around. Crying is a complex but essential means of communication and information between a baby and his parents that raises the question of their meaning.

The cry phenomenon consists of complex acoustic signals produced by the vocal cords and filtered by the vocal tract. The vibrations frequency determines the fundamental frequency, itself responsible for the perception of the cry tone (pitch). The frequency spectrum of a cry is modified during the passage through the upper airways forming broad bands called "resonance frequency" or "formants".

From the specificity of a crying sequence, it is possible to extract dynamic information and relate it to the perception that the adult has of it. Thus dynamic crying is often perceived by the adult as an imminent need of the baby.

Some studies have shown that a child's crying may change according to his degree of discomfort, suggesting that crying was a "graduated signal" whose frequency and timbre could vary along a continuum. These changes would explain why adult listeners would be able to dissociate crying babies of different intensities.

Conversely, an inappropriate response to crying could gradually generate disorders of the relationship between the baby and the parent.

However, despite their potential neuro-ethological interest, knowledge of information transmitted by babies's cry remains superficial. This could be related to the relatively obsolete techniques of recording or due to the lack of objective physiological data on babies 'cry. Finally, the perception and reactions of adults when they hear crying babies are not fully understood.

lead_sponsor: Centre Hospitalier Universitaire de Saint Etienne