title: Comparison of Manual Propofol and Remifentanil Administration and Dual Closed-loop, Using Bispectral Index as the Control Variable, During Liver Transplantation

acronym: Drone-TH

summary: To compare closed-loop anesthesia to manual administration of propofol and remifentanil during liver transplantation

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, Hôpital H. Mondor

location_facility: Dept of Anesthesia and Intensive Care, Hôpital Beaujon


title: AMBIZYGO: Efficacy of High Dose [10 mg/kg/j] Liposomal Amphotericin B (Ambisome)Efficacy in Initial Zygomycosis Treatment:Phase II Trial

acronym: AMBIZYGO

summary: Evaluation after 4 weeks of treatment or at end of treatment if it occurs before. Efficacy will be defined as objective responses; complete and partial response.

status: Completed

study_completion_date_type: Actual

study_type: Interventional

primary_purpose: Treatment

enrollment_type: Actual

ReferenceType: derived

ReferenceCitation: Lanternier F, Poiree S, Elie C, Garcia-Hermoso D, Bakouboula P, Sitbon K, Herbrecht R, Wolff M, Ribaud P, Lortholary O; French Mycosis Study Group. Prospective pilot study of high-dose (10 mg/kg/day) liposomal amphotericin B (L-AMB) for the initial treatment of mucormycosis. J Antimicrob Chemother. 2015 Nov;70(11):3116-23. doi: 10.1093/jac/dkv236. Epub 2015 Aug 27.

lead_sponsor: Assistance Publique - Hôpitaux de Paris

location_facility: Hôpital Necker - Service des Maladies Infectieuses et Tropicales

intervention_type: Drug

lead_sponsor_type: academique

status_simplified: Completed


title: Effect of Amnioinfusion on External Cephalic Version After Initial Failure a Prospective Multicentric Randomized Study

acronym: AMNIO

summary:
The aim of the study is to evaluate the effect of transabdominal amnioinfusion before second external cephalic version after initial failure.Patient with a single foetus, at term, in breech presentation and after a first cephalic version are included. The randomisation determines whether the patient is included in the group with amnioinfusion before second cephalic version or with usual second cephalic version only; The efficacy's evaluation is based on rate of cephalic presentation at birth.Success rate of cephalic version with or without transabdominal amnioinfusion, rates of cesarian section in the two groups,maternal and fetal morbidity, time between second cephalic version and birth will be studied.

Prospective interventional randomized sequential comparative multicentric study. A maximum of 240 patients will be included (120 in each group). As the study is sequential it will be over as soon as a significative difference is shown.

status: Terminated

design_allocation: Randomized

enrollment_type: Anticipated

ReferenceType: background

ReferenceCitation: Benifla JL, Goffinet F, Darai E, Madelenat P. Antepartum transabdominal amnioinfusion to facilitate external cephalic version after initial failure. Obstet Gynecol. 1994 Dec;84(6):1041-2.

ReferenceCitation: Bénifla JL, Goffinet F, Bascou V, Darai E, Proust A, Madelenat P. [Transabdominal amnio-infusion facilitates external version maneuver after initial failure. Six successful attempts]. J Gynecol Obstet Biol Reprod (Paris). 1995;24(3):319-22. French.

ReferenceCitation: Boucher M, Bujold E, Marquette GP, Vezina Y. The relationship between amniotic fluid index and successful external cephalic version: a 14-year experience. Am J Obstet Gynecol. 2003 Sep;189(3):751-4.

ReferenceCitation: Cheng M, Hannah M. Breech delivery at term: a critical review of the literature. Obstet Gynecol. 1993 Oct;82(4 Pt 1):605-18. Review.

ReferenceCitation: Collaris RJ, Oei SG. External cephalic version: a safe procedure? A systematic review of version-related risks. Acta Obstet Gynecol Scand. 2004 Jun;83(6):511-8. Review.

ReferenceCitation: Collea JV, Chein C, Quilligan EJ. The randomized management of term frank breech presentation: a study of 208 cases. Am J Obstet Gynecol. 1980 May 15;137(2):235-44.

ReferenceCitation: Fernandez CO, Bloom SL, Smulian JC, Ananth CV, Wendel GD Jr. A randomized placebo-controlled evaluation of terbutaline for external cephalic version. Obstet Gynecol. 1997 Nov;90(5):775-9.

ReferenceCitation: Fischer R. Breech Presentation. 2004. http://www.emedicine.com/med/topic3272.htm

ReferenceCitation: Fisk NM, Ronderos-Dumit D, Soliani A, Nicolini U, Vaughan J, Rodeck CH. Diagnostic and therapeutic transabdominal amnioinfusion in oligohydramnios. Obstet Gynecol. 1991 Aug;78(2):270-8.

ReferenceCitation: Flamm BL, Fried MW, Lonky NM, Giles WS. External cephalic version after previous cesarean section. Am J Obstet Gynecol. 1991 Aug;165(2):370-2.

ReferenceCitation: Gembruch U, Hansmann M. Artificial instillation of amniotic fluid as a new technique for the diagnostic evaluation of cases of oligohydramnios. Prenat Diagn. 1988 Jan;8(1):33-45.

ReferenceCitation: Gimovsky ML, Wallace RL, Schifrin BS, Paul RH. Randomized management of the nonfrank breech presentation at term: a preliminary report. Am J Obstet Gynecol. 1983 May 1;146(1):34-40.

ReferenceCitation: Gramellini D, Fieni S, Kaihura C, Faiola S, Vadora E. Transabdominal antepartum amnioinfusion. Int J Gynaecol Obstet. 2003 Nov;83(2):171-8.

ReferenceCitation: Gramellini D, Fieni S, Kaihura C, Piantelli G, Verrotti C. Antepartum amnioinfusion: a review. J Matern Fetal Neonatal Med. 2003 Nov;14(5):291-6. Review.

ReferenceCitation: Gramellini D, Fieni S, Piantelli G, Faiola S, Kaihura C, Verrotti C, Cavallotti D, Viola P, Bacchini G, Vadora E. [Amnioinfusion: techniques, indications, and controlled retrospective study of 55 cases]. Acta Biomed Ateneo Parmense. 2000;71 Suppl 1:325-9. Italian.

ReferenceCitation: Hannah ME, Hannah WJ, Hewson SA, Hodnett ED, Saigal S, Willan AR. Planned caesarean section versus planned vaginal birth for breech presentation at term: a randomised multicentre trial. Term Breech Trial Collaborative Group. Lancet. 2000 Oct 21;356(9239):1375-83.

ReferenceCitation: Hellström AC, Nilsson B, Stånge L, Nylund L. When does external cephalic version succeed? Acta Obstet Gynecol Scand. 1990;69(4):281-5.

ReferenceCitation: Hofmeyr GJ. Interventions to help external cephalic version for breech presentation at term. Cochrane Database Syst Rev. 2004;(1):CD000184. Review. Update in: Cochrane Database Syst Rev. 2012;1:CD000184.

ReferenceCitation: Hofmeyr GJ, Hannah ME. Planned caesarean section for term breech delivery. Cochrane Database Syst Rev. 2003;(3):CD000166. Review. Update in: Cochrane Database Syst Rev. 2015;7:CD000166.

ReferenceCitation: Hofmeyr GJ, Kulier R. Cephalic version by postural management for breech presentation. Cochrane Database Syst Rev. 2000;(3):CD000051. Review. Update in: Cochrane Database Syst Rev. 2012;10:CD000051.

ReferenceCitation: Hofmeyr GJ, Kulier R. External cephalic version for breech presentation at term (Cochrane Review). In: The Cochrane Library, Issue 3, 2004d. Chichester, UK: John Wiley & Sons, Ltd

ReferenceCitation: Hofmeyr GJ. External cephalic version facilitation for breech presentation at term. Cochrane Database Syst Rev. 2000;(2):CD000184. Review. Update in: Cochrane Database Syst Rev. 2001;(4):CD000184.

ReferenceCitation: Hofmeyr GJ. External cephalic version for breech presentation before term (Cochrane Review). In: The Cochrane Library, Issue 3, 2004e. Chichester, UK: John Wiley & Sons, Ltd.

ReferenceCitation: Hutton EK, Kaufman K, Hodnett E, Amankwah K, Hewson SA, McKay D, Szalai JP, Hannah ME. External cephalic version beginning at 34 weeks' gestation versus 37 weeks' gestation: a randomized multicenter trial. Am J Obstet Gynecol. 2003 Jul;189(1):245-54.

ReferenceCitation: Kotaska A. Inappropriate use of randomised trials to evaluate complex phenomena: case study of vaginal breech delivery. BMJ. 2004 Oct 30;329(7473):1039-42. Review. Erratum in: BMJ. 2004 Dec 11;329(7479):1385.

ReferenceCitation: Lansac J, Body G, Perrotin F, Marret H. Pratique de l'accouchement. Paris: Masson ; 2001, p. 365-369.

ReferenceCitation: Le Bret T, Grangé G, Goffinet F, Cabrol D. [External cephalic version: experience about 237 versions at Port-Royal maternity]. J Gynecol Obstet Biol Reprod (Paris). 2004 Jun;33(4):297-303. French.

ReferenceCitation: Lilford RJ, van Coeverden de Groot HA, Moore PJ, Bingham P. The relative risks of caesarean section (intrapartum and elective) and vaginal delivery: a detailed analysis to exclude the effects of medical disorders and other acute pre-existing physiological disturbances. Br J Obstet Gynaecol. 1990 Oct;97(10):883-92.

ReferenceCitation: Newman RB, Peacock BS, VanDorsten JP, Hunt HH. Predicting success of external cephalic version. Am J Obstet Gynecol. 1993 Aug;169(2 Pt 1):245-9; discussion 249-50.

ReferenceCitation: Novakov-Mikić A, Stojić S, Bogavac M, Mandić A. [Amnionic infusion therapy in conditions with low amnionic fluid levels]. Med Pregl. 2003 Jan-Feb;56(1-2):33-7. Croatian.

ReferenceCitation: Perrotin F, Sauget S, Laffont M, Lansac J, Body G. Version par manœuvre externe: nouveaux apports techniques. In: Collège National des Gynécologues Obstétriciens Français. Mises à jour en Gynécologie Obstétrique - VIGOT Ed. - Paris, 2003;25:5-23

ReferenceCitation: Pritchard JA, MacDonald PC. Dystocia caused by abnormalities in presentation, position, or development of the fetus. Williams Obstetrics. Norwalk, CT: Appleton-Century-Crofts; 1980, p. 787-796.

ReferenceCitation: Rietberg CC, Elferink-Stinkens PM, Brand R, van Loon AJ, Van Hemel OJ, Visser GH. Term breech presentation in The Netherlands from 1995 to 1999: mortality and morbidity in relation to the mode of delivery of 33824 infants. BJOG. 2003 Jun;110(6):604-9.

ReferenceCitation: Royal College of Obstetricians and Gynaecologists Clinical Audit Unit. Effective procedures in maternity care suitable for audit. London: RCOG Press; 1997;4(7). Breech presentation at term, p. 32.

ReferenceCitation: Royal College of Obstetricians and Gynaecologists The management of breech presentation. 2001

ReferenceCitation: Lee D, Contreras M, Robson SC, Rodeck CH, Whittle MJ. Recommendations for the use of anti-D immunoglobulin for Rh prophylaxis. British Blood Transfusion Society and the Royal College of Obstetricians and Gynaecologists. Transfus Med. 1999 Mar;9(1):93-7.

ReferenceCitation: Shalev E, Battino S, Giladi Y, Edelstein S. External cephalic version at term--using tocolysis. Acta Obstet Gynecol Scand. 1993 Aug;72(6):455-7.

ReferenceCitation: Stuart IP. Term breech trial. Lancet. 2001 Jan 20;357(9251):228.

ReferenceCitation: Wagner A, Potin J, Himily V, Arbeille P, Perrotin F. The "Loss Of Resistance" Syringe: a useful tool for difficult amnioinfusion. Fetal Diagn Ther (submitted).

ReferenceCitation: Mousa HA. Re: Lédée et al. Management in intractable obstetric haemorrhage: an audit study on 61 cases. Eur J Obstet Gynecol Reprod Biol 2001;94:189-96. Eur J Obstet Gynecol Reprod Biol. 2001 Dec 10;100(1):116-7.

ReferenceCitation: Zhang J, Bowes WA Jr, Fortney JA. Efficacy of external cephalic version: a review. Obstet Gynecol. 1993 Aug;82(2):306-12. Review.

ReferenceCitation: Diguisto C, Winer N, Descriaud C, Tavernier E, Weymuller V, Giraudeau B, Perrotin F. Amnioinfusion for women with a singleton breech presentation and a previous failed external cephalic version: a randomized controlled trial. J Matern Fetal Neonatal Med. 2018 Apr;31(8):993-999. doi: 10.1080/14767058.2017.1304909. Epub 2017 Mar 28.

lead_sponsor: University Hospital, Tours

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

intervention_type: Procedure

status_simplified: Unknown


title: Evaluation of a New Pain Management Protocol Involving Intranasal Sufentanil in the Emergency Room : a Prospective Observational Study.

acronym: SUURGE

summary:
Until now, the Mulhouse emergency department used a protocol for severe pain based on morphine titration. In order to relieve patients' pain more quickly, a new protocol was implemented based on the use of intranasal sufentanil.

The primary objective of the study is to prospectively assess the efficacy of the new pain management protocol implemented in the emergency department and based on intranasal sufentanil in combination with paracetamol and codeine for pain of moderate intensity and intranasal sufentanil in combination with paracetamol followed by morphine titration for severe pain. This new pain management protocol has been updated as part of the upcoming French High Authority for Health hospital certification, for which pain management is one of the priority criteria. This research does not change the routine care given to the patient.

study_start_date_type: Actual

status: Recruiting

study_completion_date_type: Anticipated

study_type: Observational

time_perspective: Prospective

ipd_sharing: No

lead_sponsor: Groupe Hospitalier de la Region de Mulhouse et Sud Alsace

intervention_type: Other

status_simplified: Ongoing


title: Stage IB2 to IVA Uterine Cervical Cancer: Phase 2 Study to Assess a New Therapeutic Sequence Associating a Radiochemotherapy Followed by Adjuvant Chemotherapy Based on Gemcitabine

acronym: GEMCOL

summary: The scope of the trial is to assess the efficacy of the association gemcitabine-cisplatin + radiotherapy followed by an adjuvant chemotherapy

design_allocation: Non-Randomized

lead_sponsor: Centre Oscar Lambret

location_facility:
Centre Leonard de Vinci
Centre Oscar Lambret

lead_sponsor_type: industriel


title: Biliary or Digestive Protection by Room Air Interposition for Thermal Ablation of Central Hepatic Tumors With High Iatrogenic Risk

summary:
This study aims to analyse retrospectively the feasibility, the safety, and the efficiency, of biliary or digestive protection with room air interposition for thermal ablation of central liver tumors with high iatrogenic risk.

Thermal ablation is a mini-invasive and curative treatement of liver tumors. However, it requires to be carefull about surrunding organs, such as digestive structures or central biliary tree, which can be injured if not insulated.

The technique of gas interposition to protect adjacent gut is already known and validated with carbonic gas. Nevertheless, resorption of this gas is very fast, making its use tricky to keep a correct insulation during the whole thermal ablation process.

Room air interposition is easy to use and can offer a slow resorption speed. Furthermore no datas are available concerning the use of room air whatever the organ protected, and the protection of central biliary tree whatever the gas used.

time_perspective: Retrospective

lead_sponsor: Centre Hospitalier Universitaire de Nice


type: Other Identifier

title: Standardization of the Dry Immersion Model Used as a Ground-based Model to Mimic Weightlessness. Phase 2: a 5-day Dry Immersion Study on 20 Healthy Male Volunteers (VIVALDI2)

summary:
Dry immersion (DI) is a ground-based model of prolonged conditions of simulated microgravity. Dry immersion involves immersing the subject in water covered with an elastic waterproof fabric. As a result, the immersed subject, who is freely suspended in the water mass, remains dry. Within a relatively short duration, the model can faithfully reproduce most physiological effects of actual microgravity, including centralization of body fluids, support unloading, and hypokinesia.

The main objective of the present study is to investigate the physiological effects of 5 days of dry immersion in 20 healthy male subjects, and to obtain DI-in-Men Reference Dataset. A set of measurements will assess the changes in the cardiovascular, neuro-ophthalmological, hematological, metabolic, sensorimotor, immune, muscle and bone systems.

study_start_date_type: Anticipated

status: Not yet recruiting

primary_purpose: Basic Science

ReferenceCitation: Navasiolava NM, Custaud MA, Tomilovskaya ES, Larina IM, Mano T, Gauquelin-Koch G, Gharib C, Kozlovskaya IB. Long-term dry immersion: review and prospects. Eur J Appl Physiol. 2011 Jul;111(7):1235-60. doi: 10.1007/s00421-010-1750-x. Epub 2010 Dec 14. Review.

ReferenceCitation: De Abreu S, Amirova L, Murphy R, Wallace R, Twomey L, Gauquelin-Koch G, Raverot V, Larcher F, Custaud MA, Navasiolava N. Multi-System Deconditioning in 3-Day Dry Immersion without Daily Raise. Front Physiol. 2017 Oct 13;8:799. doi: 10.3389/fphys.2017.00799. eCollection 2017.

ReferenceCitation: Kermorgant M, Leca F, Nasr N, Custaud MA, Geeraerts T, Czosnyka M, Arvanitis DN, Senard JM, Pavy-Le Traon A. Impacts of Simulated Weightlessness by Dry Immersion on Optic Nerve Sheath Diameter and Cerebral Autoregulation. Front Physiol. 2017 Oct 12;8:780. doi: 10.3389/fphys.2017.00780. eCollection 2017.

ReferenceCitation: Linossier MT, Amirova LE, Thomas M, Normand M, Bareille MP, Gauquelin-Koch G, Beck A, Costes-Salon MC, Bonneau C, Gharib C, Custaud MA, Vico L. Effects of short-term dry immersion on bone remodeling markers, insulin and adipokines. PLoS One. 2017 Aug 14;12(8):e0182970. doi: 10.1371/journal.pone.0182970. eCollection 2017.

lead_sponsor: Centre National d'Etudes Spatiales


title: Target-controlled Infusion of Propofol and Remifentanil During General Anaesthesia Guided by Entropy of the Electroencephalogram: Comparison Between Manual Perfusion and Automated Perfusion

summary: This study compares the manual administration of propofol and remifentanil and their delivery using a combined closed-loop anesthesia system, entropy of the EEG being the controller.

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.

intervention_type: Device


title: Pulmonary Rehabilitation for COPD Patients: Can Performance Predict Exacerbation?

acronym: PREDICT

summary: The aim of pulmonary rehabilitation is to improve exercise capacity and reduce dyspnoea. As well as improving the patient's overall condition, pulmonary rehabilitation provides a means to monitor the patient regularly. During physical exercise, the increased activity of the muscle system increases cardiac and respiratory output. If the patient's respiratory status deteriorates, as occurs, for example, before the onset of an exacerbation, exercise capacity could be reasonably expected to reduce. The investigators hypothesised, therefore, that changes in the physical capacity of patients with COPD during a rehabilitation session could provide a predictive indication regarding the risk of occurrence of exacerbation.

ipd_sharing: Undecided

ipd_sharing_description: by contact the correspondent author

lead_sponsor: Groupe Hospitalier du Havre


title: Comparison of Vascular Risk in Patients Treated for Obstructive Sleep Apnea/Hypopnea Syndrome (OSAHS) With Continuous Positive Airway Pressure (CPAP) and Mandibular Advancement Orthosis

acronym: SAHOSVAS

summary: a monocentric,non interventional, prospective study to compare cardiovascular risk in patients with Obstructive Sleep Apnea/Hypopnea Syndrome treated with Continuous Positive Airway Pressure (CPAP) and Mandibular Advancement Orthosis.

lead_sponsor: Centre Hospitalier de Valence


title: Patient-reported Outcoms in Status Epilepticus Requiring Intensive Care Unit Management

acronym: POSEIDON

summary:
Status epilepticus (SE) is a common life-threatening neurological emergency in which prolonged or multiple closely spaced seizures can result in long-term impairments. SE remains associated with considerable mortality and morbidity, with little progress over the last three decades. The proportion of patients who die in the hospital is about 20% overall and 40% in patients with refractory SE. Morbidity is more difficult to evaluate, as adverse effects of SE are often difficult to differentiate from those attributed to the cause of SE. Our experience suggests that nearly 50% of patients may experience long-term functional impairments.

The precise description of the consequences of these functional impairments and their impact on quality of life after SE requiring intensive care management has been little studied.

Indeed, if cognitive, physical and mental impairments are now identified in the populations of patients who required intensive care under the term post-resuscitation syndrome (PICS), neuronal lesions consecutive to the SE itself or to its cause could be responsible for these different functional alterations. Thus, the following have been described: (i) cognitive disorders in the areas of attention, executive functions and verbal fluency, visual and working memory disorders, but also spatio-temporal disorders; (ii) physical disorders such as the so-called post-resuscitation polyneuromyopathy; and (iii) mental disorders such as anxiety disorders, depressive states or those related to post-traumatic stress.

Assessment and characterization of patient-reported outcomes is essential to complement the holistic assessment of clinically relevant outcomes from the patient's perspective. Here, we propose the development of a cross-sectional collection of PROs of the different constituents of PICs and HR-QOLs, and associated with functional patient outcomes, in those who required ICU management for status epilepticus.

lead_sponsor: Versailles Hospital


title: A Randomized Double-Blind Cross-Over Study Comparing the Pharmacodynamic (PD)Response in Subjects With ACS Receiving 14 Days 10-mg Maintenance Dose (MD) Prasugrel vs 14 Days 150-mg MD Clopidogrel After Using a 900-mg Loading Dose (LD) of Clopidogrel to Reduce Ongoing Platelet Activation

summary: This is a multicenter, randomized, double-blind, cross-over study to compare the pharmacodynamic response in subjects with Acute Coronary Syndrome receiving a 10-mg maintenance dose (MD) of prasugrel compared with a 150-mg maintenance dose of clopidogrel, following a 900-mg loading dose (LD) of clopidogrel.

lead_sponsor: Eli Lilly and Company

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


title: Study of the Effects of Muscular Activity on Iron Metabolism: A Pilot Study on Healthy Volunteers

summary: The aim of this study is to evaluate the effect of muscular exercise on iron metabolism in healthy volunteers. Fourteen healthy male subjects will have to pedal on an ergocycle for 45 minutes, and urine and blood samples will be collected regularly to measure hemojuvelin, hepcidin, iron and transferrin levels.

status: Unknown status

lead_sponsor: Rennes University Hospital

location_facility: Service des Maladies du Foie - Hôpital de Pontchaillou

location_facility: Unité de Biologie et Médecine du Sport - Hôpital de Pontchaillou

intervention_type: Behavioral


title: Development of Guidance Algorithms for Acquisition of Echocardiographic Reference Views

summary:
Echocardiography is the examination of choice for the study of cardiac pathologies. Interest of echocardiography for other medical specialties has already been demonstrated (intensive care in the case of hemodynamic failure - in intra and extra hospital emergency medicine for the initial assessment of chest pain or dyspnea).

The expansion of echocardiography'use has been catalyzed by miniaturization of echographic systems and decrease in their price. Recently, probes directly connected to a tablet or phone have been developed at a limited cost.

Therefore, it's possible to consider these ultrasound scanners as the new stethoscope that could be used by any health professional.

The last limit to this democratization is the training, especially for non-specialists (non-cardiologists).

primary_purpose: Other

lead_sponsor: University Hospital, Bordeaux


title: Evaluation of the Efficacy of 17 Alpha-hydroxyprogesterones Caproate for the Prevention of Preterm Delivery

summary:
To demonstrate that the intramuscular administration of 17 alpha hydroxyprogesterones caproate allows to reduce the risk of preterm delivery, in 3 high risk populations defined by the association of an ultrasonographic cervical length egal and inferiority 26 mm between 20 and 32 weeks of gestation and:

either a first episode of preterm labor stopped by acute tocolysis;
either a history of late miscarriage or premature delivery or uterine malformation or DES
either a twin pregnancy. Therefore, a randomised, multicentre trial has been designed with initial stratification according to these three risk groups, opened with two parallel arms.

ReferenceCitation: Rozenberg P, Rudant J, Chevret S, Boulogne AI, Ville Y. Repeat measurement of cervical length after successful tocolysis. Obstet Gynecol. 2004 Nov;104(5 Pt 1):995-9.

ReferenceCitation: Winer N, Bretelle F, Senat MV, Bohec C, Deruelle P, Perrotin F, Connan L, Vayssière C, Langer B, Capelle M, Azimi S, Porcher R, Rozenberg P; Groupe de Recherche en Obstétrique et Gynécologie. 17 alpha-hydroxyprogesterone caproate does not prolong pregnancy or reduce the rate of preterm birth in women at high risk for preterm delivery and a short cervix: a randomized controlled trial. Am J Obstet Gynecol. 2015 Apr;212(4):485.e1-485.e10. doi: 10.1016/j.ajog.2014.10.1097. Epub 2014 Oct 30.

location_facility:
CHI Poissy st Germain
Chi Poissy St Germain


title: Early Administration of L-carnitine in Hemodialysis Patients: Double Blind Randomized Trial Versus Placebo

summary: Hemodialysis is a cause of carnitine deficiency. The deficiency of carnitine induces an anemia by an increase fragility of the red blood cells, a muscular fatigue and a cardiac dysfunction. We proposed to evaluate the benefit of an early administration of L-carnitine in hemodialysis patients. The patients should be included in the first month after the start of chronic hemodialysis, randomized to receive L-carnitine or placebo and should be followed-up during one year.

ReferenceCitation: Mercadal L, Tezenas du Montcel S, Chonchol MB, Debure A, Depreneuf H, Servais A, Bassilios N, Assogba U, Allouache M, Prié D. Effects of L-Carnitine on Mineral Metabolism in the Multicentre, Randomized, Double Blind, Placebo-Controlled CARNIDIAL Trial. Am J Nephrol. 2018;48(5):349-356. doi: 10.1159/000494338. Epub 2018 Nov 8.

location_facility: HOPITAL LA PITIE SALPETRIERE, service de Néphrologie


title: Evaluation and Medico Economic Study of FIBROSCAN in Patients With Viral Hepatitis

acronym: FIBROSTIC

summary: A new approach to the evaluation of liver fibrosis has been proposed using PULSOMETRY. The objective is to evaluate the diagnostic performances of the FIBROSCAN technique, together with non-invasive techniques, and to determine how it is able to predict the histological fibrosis score, defined by the METAVIR score. This transversal study aims to compare the evaluation of hepatic fibrosis obtained by FIBROSCAN and histology (METAVIR score) in 2550 consecutive patients taken in charge for a liver biopsy. The results of the study will compare the respective performances of these techniques in the prediction of the METAVIR score, and help in the recommendation of the care of patients with viral hepatitis B and C; these methods will undergo a medico-economic study.

location_facility:
Hopital Beaujon
Hopital Saint-Antoine


title: Evaluation of Movement and Muscular Alterations in Subjects With Severe Knee Osteoarthritis Who Are to Receive a Total Knee Replacement

acronym: MOUV-GOPRO

summary:
Osteoarthritis (OA) is the most common joint disease. It is characterized by a progressive destruction of all the components of the joint, especially the cartilage. This leads to pain, loss of mobility and can be a major handicap for some patients.

Gonarthrosis, or osteoarthritis of the knee, affects 30% of people between the ages of 65 and 75 and is one of the most disabling conditions. In the final stage, the only therapeutic option to relieve patients is to replace the joint with a total knee prosthesis.

Thanks to the contribution of an evaluation technique based on inertial sensors (X-SENS device), our objective is to better evaluate and understand the movement deficit in knee OA subjects.

The hypothesis is that, thanks to the contribution of a technique based on inertial sensors (X-SENS), the investigators can better evaluate the movement deficit of knee OA subjects. The goal is to propose specific, rapid telekinetic biomarkers, allowing a better evaluation of functional improvements following therapeutic interventions, such as a total knee replacement.

primary_purpose: Supportive Care

lead_sponsor: University Hospital, Montpellier


title: Identifying Morphological and Biological Biomarkers of the Venous Thromboembolic Risk Risk Related to Aging

summary: Aging is an independent risk factor, without any clear explanation. The primary aim of the study is to depict the effect of aging on the coagulation fibrinolysis parameters and microparticles.

lead_sponsor: Hopital Lariboisière

location_facility:
Hopital Lariboisiere
Hopital Lariboisière


title: Biological Efficacy of Clopidogrel 600 mg Loading Dose Followed by 75 mg Maintenance Dose After Implantation of Drug-eluting Stents in Patients With Diabetes Mellitus or Metabolic Syndrome (SPACE)

acronym: SPACE

summary:
The risk of thrombotic complications after implantation of drug-eluting stents (DES) may be increased in patients with diabetes mellitus (DM) or metabolic syndrome (MS). It is recommended that all patients take an association of aspirin and clopidogrel for several months after DES implantation to reduce this risk. However, the biological efficacy of current antiplatelet therapies has not been studied prospectively and specifically in DM or MS patients.

Our aim is to study the biological efficacy of an association of aspirin and clopidogrel (600 mg loading dose followed by 75 mg maintenance dose) using an assay measuring ex vivo shear-induced platelet aggregation (SIPA), along with other assays measuring platelet activation and aggregation, in patients with DM, MS, or no DM/MS.

Patients with stable coronary artery disease and successful DES implantation in native coronary arteries will be eligible. They will be stratified at entry according to their metabolic status (DM, MS, or no DM/MS). Measurements will be performed 6-24 hours after clopidogrel loading dose (acute effects) and 4 months later under clopidogrel maintenance dose (chronic effects).

Study end-points:

A. Primary biological end-point: To compare SIPA levels in DM vs. MS vs. no DM/MS patients.

B. Secondary biological end-points:

To compare the results of other tests of platelet aggregation/activation in DM vs. MS vs. no DM/MS patients.
To compare the acute (6-24 hours after clopidogrel loading dose) and chronic (4 months later) results of the above mentioned tests. These comparisons will be performed in the overall population and in each group (DM, MS, no DM/MS).

C. Secondary clinical end-points: To study the relationship between SIPA levels (and the other tests of platelet aggregation/activation) and the occurrence of:

Periprocedural myocardial infarctions
Major adverse cardiac events (cardiovascular death, myocardial infarction or ischaemia-driven target vessel revascularization) at 4 and 12 months after stent implantation.

We, the researchers at Assistance PUBLIQUE - HOPITAUX de Paris, anticipate our study may help improve our knowledge of the efficacy of current antiplatelet therapies in DM and MS patients treated with DES.

primary_purpose: Diagnostic

ReferenceCitation: Silber S, Albertsson P, Avilés FF, Camici PG, Colombo A, Hamm C, Jørgensen E, Marco J, Nordrehaug JE, Ruzyllo W, Urban P, Stone GW, Wijns W; Task Force for Percutaneous Coronary Interventions of the European Society of Cardiology. Guidelines for percutaneous coronary interventions. The Task Force for Percutaneous Coronary Interventions of the European Society of Cardiology. Eur Heart J. 2005 Apr;26(8):804-47. Epub 2005 Mar 15.

ReferenceCitation: Serebruany VL, Steinhubl SR, Berger PB, Malinin AI, Bhatt DL, Topol EJ. Variability in platelet responsiveness to clopidogrel among 544 individuals. J Am Coll Cardiol. 2005 Jan 18;45(2):246-51.

ReferenceCitation: Gurbel PA, Bliden KP, Hiatt BL, O'Connor CM. Clopidogrel for coronary stenting: response variability, drug resistance, and the effect of pretreatment platelet reactivity. Circulation. 2003 Jun 17;107(23):2908-13. Epub 2003 Jun 9.

ReferenceCitation: Kastrati A, Mehilli J, Schühlen H, Dirschinger J, Dotzer F, ten Berg JM, Neumann FJ, Bollwein H, Volmer C, Gawaz M, Berger PB, Schömig A; Intracoronary Stenting and Antithrombotic Regimen-Rapid Early Action for Coronary Treatment Study Investigators. A clinical trial of abciximab in elective percutaneous coronary intervention after pretreatment with clopidogrel. N Engl J Med. 2004 Jan 15;350(3):232-8.

ReferenceCitation: Patti G, Colonna G, Pasceri V, Pepe LL, Montinaro A, Di Sciascio G. Randomized trial of high loading dose of clopidogrel for reduction of periprocedural myocardial infarction in patients undergoing coronary intervention: results from the ARMYDA-2 (Antiplatelet therapy for Reduction of MYocardial Damage during Angioplasty) study. Circulation. 2005 Apr 26;111(16):2099-106. Epub 2005 Mar 6.

ReferenceCitation: Matetzky S, Shenkman B, Guetta V, Shechter M, Beinart R, Goldenberg I, Novikov I, Pres H, Savion N, Varon D, Hod H. Clopidogrel resistance is associated with increased risk of recurrent atherothrombotic events in patients with acute myocardial infarction. Circulation. 2004 Jun 29;109(25):3171-5. Epub 2004 Jun 7. Erratum in: Circulation. 2011 Oct 25;124(17):e459. Bienart, Roy [corrected to Beinart, Roy].

ReferenceCitation: Ajzenberg N, Aubry P, Huisse MG, Cachier A, El Amara W, Feldman LJ, Himbert D, Baruch D, Guillin MC, Steg PG. Enhanced shear-induced platelet aggregation in patients who experience subacute stent thrombosis: a case-control study. J Am Coll Cardiol. 2005 Jun 7;45(11):1753-6.

location_facility: Département de Cardiologie, Hôpital Bichat, Assistance Publique-Hôpitaux de Paris

location_facility: Service d'Hématologie et d'Immunologie Biologiques, Hôpital Bichat, Assistance Publique-Hôpitaux de Paris


title: Anatomical and Functional MRI Study of Episodic Memory in Epileptic Compared to Normal Children

summary: Memory is a cognitive function whose development is still poorly documented in children, but which is often disturbed in temporal epilepsy. There are no studies about the disorders of episodic memory. The investigations using functional MRI (fMRI) are scarce, they do not involve this field and none are dedicated to children. The objectives of this project are to study the neuronal networks involved in episodic memory in normal children, as well as the disorders of episodic memory in children with epilepsy and the mechanisms of cognitive and cerebral reorganization in epilepsy.

ReferenceCitation: Jambaqué I, Dellatolas G, Dulac O, Ponsot G, Signoret JL. Verbal and visual memory impairment in children with epilepsy. Neuropsychologia. 1993 Dec;31(12):1321-37.

ReferenceCitation: Hertz-Pannier L, Chiron C, Jambaqué I, Renaux-Kieffer V, Van de Moortele PF, Delalande O, Fohlen M, Brunelle F, Le Bihan D. Late plasticity for language in a child's non-dominant hemisphere: a pre- and post-surgery fMRI study. Brain. 2002 Feb;125(Pt 2):361-72.

location_facility: Service Hospitalier Frédéric Joliot (SHFJ)


title: Prospective and Randomized Study to Evaluate Interest of Ultracision Use in Inguinal Lymph Nodes Curage.

summary: The purpose of this study is to evaluate the decrease of post-operative morbidity in inguinal lymphadenectomies realised for vulvar tumors and inferior limb skin tumors by use of Ultracision with regard to classical operative techniques.

lead_sponsor: Institut Claudius Regaud

location_facility:
Institut Claudius Regaud
Institut Paoli-Calmettes


title: Phase I/II Trial to Assess the Radiosensitizing Effect of ZARNESTRA in Patients With Glioblastoma Multiforme

summary: The purpose of this study is to determine the efficacy by the determination of the Time To Progression (TTP) in patients with resectable GBM or non surgical GBM with a size less than 5 cm treated with the combination of ZARNESTRA plus Radiation therapy.

location_facility:
Institut Claudius Regaud
Centre Jean Perrin


title: Diagnosis of Coronary Artery Disease in High Risk Diabetic Patients :Comparison Between Stress Echocardiography and Stress Scintigraphy in the Detection of Silent Myocardial Ischemia

summary: The aim of this study is to determine in high risk diabetics if the positive predictive value of stress echocardiography is superior to the positive predictive value of stress scintigraphy in the diagnosis of coronary stenosis > 50%.

ReferenceCitation: Jacqueminet S, Barthelemy O, Rouzet F, Isnard R, Halbron M, Bouzamondo A, Le Guludec D, Grimaldi A, Metzger JP, Le Feuvre C. A randomized study comparing isotope and echocardiography stress testing in the screening of silent myocardial ischaemia in type 2 diabetic patients. Diabetes Metab. 2010 Dec;36(6 Pt 1):463-9. doi: 10.1016/j.diabet.2010.06.005. Epub 2010 Sep 15.

lead_sponsor: Société Française de Cardiologie

location_facility: Service de diabétologie - Pitié Salpêtrière


title: Exploring Asynchronism in Operated Fallot Tetralogy : A Comparative Study of Electrical and Mechanical Activation of the Right Ventricle by Three-Dimensional Analysis

acronym: FALLOT-XI

summary: The objective of this work is to estimate the correlation between the electrical activation of the VD measured by the CARTO electrophysiological mapping system and the mechanical activation of the VD measured by 3D echocardiography and 3D speckle-tracking. Our hypothesis is that there is a strong correlation between electrical activation and mechanical activation in patients with an operated Fallot tetralogy.


title: Evaluation of Two Enteral Nutrition Strategies in Mechanically Ventilated Patients

summary: The aim of this study is to compare two strategies of early enteral nutrition in terms of efficacy and complications in mechanically ventilated patients.

primary_purpose: Prevention

lead_sponsor: University Hospital, Limoges

location_facility:
Service de réanimation Polyvalente
Service de Réanimation


title: Treatment of Spastic Equinovarus Foot After Stroke. Efficacy: Association Between Ankle Foot Orthosis and Botulinum Toxin A (BTA) Injection

summary: This study evaluates treatment for spastic foot after stroke using ankle foot orthosis with or without selective injection of BTA (Botox).

location_facility: Département de Médecine Physique et de Réadaptation, CHU Limoges


title: Individual Gait Pattern and MRI Lesion Load to Quantify Gait Impairment in MS: A Cross Sectional Study.

acronym: MS-CSI

summary: Gait alteration is frequent in MS and limitation in walking ability is a major concern in MS patients. Umanit and LMJL (Nantes university) has developed a device call egait to assess walking ability in individuals (eg MS patients).

lead_sponsor: Nantes University Hospital


title: Lung Ultrasound Score After Ear, Nose and Throat Cancer Surgery

acronym: LUSENT

summary:
After ENT cancer surgery, postoperative respiratory complications are common, especially after tracheostomy.

The objective of this study is to characterize the pulmonary status of patients after ENT cancer surgery.

We wish to collect and analyze the pulmonary abnormalities revealed by the ultrasound scans performed in the post-anesthesia care unit (PACU), at day 1 and at day 2 after ENT cancer surgery with tracheostomy.

ReferenceCitation: Goel N, Sen IM, Bakshi J. Lung ultrasonography as a tool to guide perioperative atelectasis treatment bundle in head and neck cancer patients undergoing free flap reconstructive surgeries: a preliminary observational study. Braz J Otorhinolaryngol. 2022 Mar-Apr;88(2):204-211. doi: 10.1016/j.bjorl.2020.05.030. Epub 2020 Jul 29.

ReferenceCitation: Touw HR, Parlevliet KL, Beerepoot M, Schober P, Vonk A, Twisk JW, Elbers PW, Boer C, Tuinman PR. Lung ultrasound compared with chest X-ray in diagnosing postoperative pulmonary complications following cardiothoracic surgery: a prospective observational study. Anaesthesia. 2018 Aug;73(8):946-954. doi: 10.1111/anae.14243. Epub 2018 Mar 12.

ReferenceCitation: Zieleskiewicz L, Papinko M, Lopez A, Baldovini A, Fiocchi D, Meresse Z, Boussuges A, Thomas PA, Berdah S, Creagh-Brown B, Bouhemad B, Futier E, Resseguier N, Antonini F, Duclos G, Leone M. Lung Ultrasound Findings in the Postanesthesia Care Unit Are Associated With Outcome After Major Surgery: A Prospective Observational Study in a High-Risk Cohort. Anesth Analg. 2021 Jan;132(1):172-181. doi: 10.1213/ANE.0000000000004755.

ReferenceCitation: Monastesse A, Girard F, Massicotte N, Chartrand-Lefebvre C, Girard M. Lung Ultrasonography for the Assessment of Perioperative Atelectasis: A Pilot Feasibility Study. Anesth Analg. 2017 Feb;124(2):494-504. doi: 10.1213/ANE.0000000000001603.

lead_sponsor: Centre Leon Berard

intervention_type: Diagnostic Test


title: Study of Immunogenicity of Anti-HAV Immunisation in HIV-1 Infected Patients, Co-infected or Not With HBV and/or HCV. HEP.A.VAC Study.

acronym: HEPAVAC

summary: Immunogenicity is reduced in immunocompromised patients. The aim of this prospective randomized study is to evaluate tolerance and immunogenicity of 2 doses versus 3 doses of anti-HAV vaccine in HIV-1 infected patients with CD4 count between 200 and 500 per mm3, co-infected or not with HBV and/or HCV. The factors influencing vaccine immunogenicity will be evaluate.

lead_sponsor: Assistance Publique - Hôpitaux de Paris

location_facility: CIC de vaccinologie Cochin Pasteur, Service de médecine interne, hôpital Cochin


title: A Phase II Study of Radiofrequency Ablation of Lung Tumors

summary: Radiofrequency ablation has achieved impressive results in the treatment of unresectable primary and metastatic liver cancer. Animal studies have demonstrated that radiofrequency can fully ablate lung tumors in animal models. We set up a prospective study to evaluate the local efficacy of radiofrequency ablation of lung neoplasms. The aim of the study is to prospectively evaluate local efficacy with a minimal follow-up of one year, tolerance, lung disease-free survival and survival after radiofrequency ablation of lung tumors (primary lung cancer or lung metastases).

lead_sponsor: Gustave Roussy, Cancer Campus, Grand Paris

location_facility:
Institut Bergonié
Institut Gustave Roussy


title: External Evaluation of Vancomycin Population Pharmacokinetic Models and Development of Continuous Infusion Dosing Recommendations

acronym: EOPMV

summary:
All patients treated with vancomycin hospitalized outside of ICU in Brest University Hospital from 1rst january 2019 to 1rst january 2021 will be screened for inclusion. Vancomycin dosage, age, weight and serum creatinin will be recorded.

Seven pharmacokinetic models' predictive performance will be evaluated on this database.

Using the best model, we will perform Monte-Carlo simulation to elaborate dosing nomograms and develop dosing recommandations of continuous infusion of vancomycin.

lead_sponsor: University Hospital, Brest


title: Phase III Trial of Intensity-modulated Radiotherapy Plus Cisplatin Versus Conventional Radiotherapy Plus Cisplatin in Patients With Stage III-IV Head and Neck Squamous Cell Carcinoma

summary: This is a multicentric randomized phase III trial comparing intensity-modulated radiotherapy (75 Gy) plus cisplatin versus conventional radiotherapy (70 Gy) plus cisplatin in patients with stage III-IV squamous cell carcinoma of oral cavity, oropharynx or hypopharynx. The main end points are the rate of locoregional control and the rate of xerostomia at 2 years.

ReferenceCitation: Tao Y, Auperin A, Blanchard P, Alfonsi M, Sun XS, Rives M, Pointreau Y, Castelli J, Graff P, Wong Hee Kam S, Thariat J, Veresezan O, Heymann S, Renard-Oldrini S, Lafond C, Cornely A, Casiraghi O, Boisselier P, Lapeyre M, Biau J, Bourhis J. Concurrent cisplatin and dose escalation with intensity-modulated radiotherapy (IMRT) versus conventional radiotherapy for locally advanced head and neck squamous cell carcinomas (HNSCC): GORTEC 2004-01 randomized phase III trial. Radiother Oncol. 2020 Sep;150:18-25. doi: 10.1016/j.radonc.2020.05.021. Epub 2020 May 15.

lead_sponsor: Groupe Oncologie Radiotherapie Tete et Cou

location_facility:
Centre Alexis Vautrin
Institut Gustave Roussy


title: Composition and Function of Gut Microbiota in Porto-sinusoidal Vascular Disease Associated With Variable Common Immunodeficiency

acronym: MI-MVPS

summary: This aim of this study is the evaluation of the gut microbiota imbalance occurrence and its characterization in patients with common variable immunodeficiency associated to an enteropathy with or without porto-sinusoidal vascular disease.

location_facility: Immunologie Clinique Hôpital Saint Louis

intervention_type: Biological


title: A Prospective Trial to Evaluate Immune Determinants of the Response and the Toxicity to Adoptive Cell Therapy (ACT) in Solid and Hematologic Tumors

acronym: PIONEER

summary:
This is a study to explore the phenotypic and transcriptional changes of different cellular components in the tumor following the injection of somatic cell therapy drugs.

The second objective is to explore phenotypic and transcriptional changes of different cellular components in blood and bone marrow following injection of somatic cell therapy drugs.Then correlate the phenotypic and transcriptional profile of different tumor, blood and bone marrow immune populations with clinical response and/or toxicity. And to finish this study is designed in order to identify a phenotypic, transcriptional and epigenetic profile of intra-tumoral adoptive cells and correlate this profile with clinical response and/or toxicity.

location_facility: Gustave Roussy Cancer Campus Grand Paris


title: Pilot Study, Without Direct Individual Benefice, of Biological Effect of Tarceva (OSI-774) at Posology of 150 mg by Day for Patients Stricken by ENT Epidermoid Carcinoma Waiting for First Surgical Picking up.

summary: The purpose of this study is to evaluate the biological effect of Tarceva (OSI-774) from an inhibition of EGF tumor receptor tyrosine kinase activity's point of view, for patients who are carriers of head and neck epidermoid carcinoma.

location_facility:
Institut claudius regaud
Center Oscar Lambret


title: Study of the Predictive Capacity of Peripheral Muscle Function on Quality of Life Impairment at 1 Year in Subjects With Obesity. A Cohort Study.

acronym: OBLITAM

summary:
The assessment of health status and physical function is fundamental in patients with obesity, as they play an important role among the various factors influencing quality of life in this population. Several studies have shown an association between high BMI values and a significant deterioration in quality of life, especially in women. Excess body fat in obese patients appears to be responsible for impaired muscle function. This causal link is probably linked to dysfunctions in adipose tissue, leading to a decrease in the expression of proteins responsible for muscle contraction. The recent literature highlights an alteration in quality of life, particularly in obese and elderly subjects, for which changes in muscle function are partly responsible.

Changes in muscle function can be assessed by simple, rapid and non-invasive tools. These changes in the obese patient could be predictive of reduced quality of life. To our knowledge, no study has evaluated the predictive capacity of muscle alteration assessed by ultrasound on the medium-term quality of life of obese patients.

The main objective of this study is to evaluate the predictive capacity of structural alteration of the quadriceps on the decrease in quality of life at 1 year in patients with obesity.

The secondary objectives are to assess the association between :

Grip strength and quality of life at 1 year;
Quadriceps muscle strength and quality of life at 1 year;
Ultrasound measurements of the quadriceps and quality of life at 1 year;
Ultrasound measurements of the quadriceps and autonomy at 1 year;
Grip strength and autonomy at 1 year.

This is a prospective, monocenter, observationnal and cohort study.

All outpatients for nutrition assessment will be included.

ReferenceCitation: Tamura LS, Cazzo E, Chaim EA, Piedade SR. Influence of morbid obesity on physical capacity, knee-related symptoms and overall quality of life: A cross-sectional study. Rev Assoc Med Bras (1992). 2017 Feb;63(2):142-147. doi: 10.1590/1806-9282.63.02.142.

ReferenceCitation: Toselli S, Campa F, Spiga F, Grigoletto A, Simonelli I, Gualdi-Russo E. The association between body composition and quality of life among elderly Italians. Endocrine. 2020 May;68(2):279-286. doi: 10.1007/s12020-019-02174-7. Epub 2019 Dec 31.

ReferenceCitation: Tomlinson DJ, Erskine RM, Winwood K, Morse CI, Onambélé GL. The impact of obesity on skeletal muscle architecture in untrained young vs. old women. J Anat. 2014 Dec;225(6):675-84. doi: 10.1111/joa.12248. Epub 2014 Oct 14.

ipd_sharing: Yes

ipd_sharing_description: The protocole, the statistical analysis plan and data will be available as supplementary materials with the publication. The other data that support the findings of this study will be available from the corresponding author upon reasonable request.

lead_sponsor: Hopital Forcilles


title: Reducing Inflammation in Ischemic Stroke With Colchicine, and Ticagrelor in High-risk Patients-extended Treatment in Ischemic Stroke

acronym: RIISC-THETIS

summary: REDUCING INFLAMMATION IN ISCHEMIC STROKE WITH COLCHICINE, AND TICAGRELOR IN HIGH-RISK PATIENTS-EXTENDED TREATMENT IN ISCHEMIC STROKE.

location_facility: URC Lariboisière-Fernand Widal-Saint Louis


title: Multicenter Randomized Controlled Trial Comparing One-step Partial Caries Removal to Complete Caries Removal for the Treatment of Deep Carious Lesions in Permanent Teeth DECAT DEep CAries Treatment

acronym: DECAT

summary:
This clinical trial is a national multicenter randomized controlled trial performed in parallel groups aiming to validate a treatment that preserves pulp vitality of mature permanent posterior teeth through partial removal of carious tissue and restoring tooth structure using a simple filling in one session, thus delaying premature tooth aging.

Two successive randomizations will be performed (allocation ratio 1:1); firstly for the type of excavation carried out (partial vs. complete caries removal) and secondly for the nature of the adhesive used (antibacterial adhesive vs. non-antibacterial adhesive). The second randomization will not be carried out for teeth requiring endodontic treatment after the first randomization.

The study's primary objective will be to compare, at 1 year of follow-up, the efficacy (binary success criteria) of partial caries removal versus complete caries removal in occlusal or proximal deep lesions of mature permanent posterior teeth (bicuspids and molars except third molars). Secondary objectives will include the comparison, at 1 year of follow-up, of the efficacy (binary success criteria) of an antibacterial two-step self-etch adhesive versus a traditional non-antibacterial two-step self-etch adhesive. Another secondary objective will be to compare, at two and three years of follow-up, the efficacy of partial versus complete caries removal.

The primary outcome is the success of the caries removal protocol at one year, measured according to 5 FDI criteria, while the secondary outcome is the contribution of the functional and biological dimensions of the 5 FDI criteria items to determining success or failure of the treatment. The outcome of success will be the same for all objectives, primary and secondary.

ReferenceCitation: Villat C, Attal JP, Brulat N, Decup F, Doméjean S, Dursun E, Fron-Chabouis H, Jacquot B, Muller Bolla M, Plasse-Pradelle N, Roche L, Maucort-Boulch D, Nony P, Gritsch K, Millet P, Gueyffier F, Grosgogeat B. One-step partial or complete caries removal and bonding with antibacterial or traditional self-etch adhesives: study protocol for a randomized controlled trial. Trials. 2016 Aug 15;17:404. doi: 10.1186/s13063-016-1484-0.

lead_sponsor: Hospices Civils de Lyon

location_facility: Service de consultations et traitements dentaires


type: Registry Identifier

title: Evaluation of Impact of Different Micturition Modes on Patients With Medullar Injury of Their Quality of Life and Their Occupations

acronym: URO-ActSCi

summary: The primary objective of the study is to analysis the personal determination factors (age, sex, stage of injury, pain, urinary continence and durations of spinal cord injury) and environmental determination factors (need for medical devices, nurse care and adaptation of accommodations) which affect the quality of life and their occupations on patients with medullar injury.

location_facility: Neuro-Urology Unit, Physical Medicine and Rehabilitation Department, Raymond Poincaré Hospital, APHP


title: Association Between Driving Transpulmonary Pressure and Extravascular Lung Water in Patients With ARDS

summary:
Intubated patients with the acute respiratory distress syndrome (ARDS) are usually treated with protective ventilation limiting plateau pressure below 30 centimeter of water (cmH2O) and, if possible, a driving pressure under 15 cmH2O. However, these airway pressures might not reflect the actual pressure applied to the lung. Transpulmonary pressure is the difference between airway pressure and pleural pressure, the latter is estimated by the esophageal pressure, and so it better reflects the ventilatory induced lung injury (VILI).

One of the consequences of the VILI is a increase of pulmonary edema and it could be estimated by the extravascular lung water, obtained by trans-pulmonary thermodilution.

So it could exist a link between the driving trans-pulmonary pressure and the extravascular lung water.

lead_sponsor: Bicetre Hospital

location_facility: Medical Intensive Care Unit, Bicêtre Hospital


title: Real-life Use of Cefazolin for the Treatment of Meticillin-susceptible Staphylococcal Infective Endocarditis: Comparison to a Treatment Cohort With Penicillin M

acronym: CEFASTA

summary: Retrospective, regional, multicenter study (including the Annecy-Genevois Hospital Center, the Chambéry Métropole Savoie Hospital Center, and the Grenoble University Hospital Center), comparing a cohort of patients treated with Cefazolin with a cohort of patients treated with Penicillin M

lead_sponsor: Centre Hospitalier Annecy Genevois


title: Mid-Term Follow-up Assessment After Exposure to Natural Disaster

acronym: MFAE-ND

summary: The present study proposes to carry out an evaluation of the children of adolescents who were seen by the teams of the Cellules d'Urgence Médico-Psychologique (CUMP) following the Alex storm in October 2020. A clinical child psychiatric and psychological evaluation will be carried out, with collection of socio-demographic data

lead_sponsor: Fondation Lenval

location_facility: Hopitaux Pediatriques de Nice Chu-Lenval


title: Identification of Human Circulating Adipocyte and Muscle Biomarkers Potentially Predictive of Diabetes Remission After Bariatric Surgery in Obese and Type 2 Diabetic Subjects.

acronym: BARIAKINES

summary: This study focuses on identifying potentially predictive human circulating adipocyte and muscle biomarkers of diabetes remission after bariatric surgery in obese type 2 diabetic (T2D) subjects.

lead_sponsor: University Hospital, Toulouse


title: Immunopathology of Loeys-Dietz Syndrome

acronym: I-LoDiS

summary:
Loeys-Dietz syndrome (LDS) is a rare vascular genetic disorder (estimated prevalence 1/25,000-1/100,000) due primarily to mutations in the Transforming growth factor beta (TGF-β) cytokine receptor 1 and 2 genes. In addition to a common vascular phenotype with Marfan syndrome (dilatation of the ascending aorta, arachnodactyly, lens dislocation), patients present specific malformations (bifid uvula, hypertelorism, tortuous arteries) and immuno-allergic manifestations (asthma, eczema, food allergy, eosinophilic esophagitis, chronic inflammatory bowel disease).

Pathophysiologically, LDS appears to be associated with hyperactivation of the intracellular TGF-β signaling pathway in a manner similar to Marfan syndrome, as evidenced by increased intracellular phosphorylated Smad2/3 (pSmad2/3) in lymphocytes. The immuno-allergic complications appear paradoxical because of the major immunosuppressive role of this cytokine on lymphoid and myeloid immune lineages.

The biological description of immunological abnormalities associated with LDS is based on a single 2013 study that found increased regulatory T (Treg) and Th2 lymphocyte polarizations, as well as increased circulating eosinophil and total IgE levels.

In order to better understand the underlying mechanisms, the investigators propose to perform a descriptive clinical-biological study to identify and study the immune subpopulations most impacted by the causative mutations of LDS.

location_facility: Hôpital Femme-Mère-Enfant / Centre de Compétences pour le syndrome de Marfan et apparentés


acronym: EFFIKIR

title: Double-Blind Placebo-Controlled Randomized Phase 2 Study of IPH2102 as Maintenance Treatment in Elderly Patients With Acute Myeloid Leukemia (AML) in First Complete Remission

lead_sponsor: Innate Pharma

source: euctr

location_facility:
CHU Purpan
CH Valenciennes
Institut Paoli - Calmettes
CHU Angers
Centre Hospitalier de Mulhouse
CHU de Nancy Hôpitaux de Brabois
CHR d'Orléans
Hôpital Avicenne
CH Saint-Jean
Centre Antoine Lacassagne
Centre hospitalier Victor Dupouy
CH Saint-Quentin
Hôpital Claude Huriez
Institut Gustave Roussy
Hôpital Necker
Hôpital Saint-Louis
Centre Hospitalier de Versailles
Hôpital Militaire Percy
Hôpital Haute Pierre et Hôpital Civil
CHU Saint Eloi
Centre René Huguenin
CH de Meaux
CHU de Reims
CHU Estaing
Centre hospitalier de la côte Basque
CH René Dubos
CHU de Besançon
Hôpital Saint-Antoine
Centre hospitalier Lyon Sud
CHU d'Amiens
CHG de Béziers
CH de Blois
CHU de Nantes
CHU de Bordeaux - Hôpital Haut-Lévêque
CHU de Grenoble
CHU de Poitiers
CHR d'Annecy
Hôpital Morvan CHU Brest
Centre Henri Becquerel
CHU de Limoges
CHU Caremeau
Hôpital Henri Mondor
Centre hospitalier sud francilien

summary: Double-Blind Placebo-Controlled Randomized Phase 2 Study evaluating the efficacy of lirilumab (IPH2102/BMS-986015) as Maintenance Treatment administered in elderly patients with Acute Myeloid Leukemia (AML) in first complete remission


title: A Retrospective Study of Vital Mechanism of NETs Formation vs. Suicidal Mechanism of NETs Formation During Normal Pregnancy and Preeclampsia

acronym: GrossNETs

summary: Formation of neutrophil extracellular traps (NETs) is a process of activation of neutrophils, which then generate filaments containing DNA, enzymes and extracellular histones. Two mechanisms of formation of NETs are described in the literature: vital mechanism via Toll Like Receptors (TLRs) and suicidal mechanism, dependent on the reactive oxygen species (ROS) pathway. The description of these two mechanisms of formation of NETs is recent and no data exist in the context of pregnancy.

status: Active, not recruiting

lead_sponsor: Centre Hospitalier Universitaire de Nīmes


title: Evaluation of a Modified Anti-Platelet Therapy Associated With Low-dose DES Firehawk in Acute Myocardial Infarction Patients Treated With Complete Revascularization Strategy

acronym: TARGET-FIRST

summary: The study aims to evaluate a modified antiplatelet therapy associated with Firehawk low-dose rapamycin DES in acute myocardial infarction patients treated with complete revascularization strategy. The modified antiplatelet therapy consists of a reduced duration of Dual Antiplatelet Therapy post procedure (ie. 1 month duration) followed by P2Y12 inhibitor monotherapy for the next 11 months. It is hypothesized that in the setting of clinically stable, low to moderate complexity acute Myocardial Infarction patients, a modern approach combining a stent with high biocompatibility feature, complete revascularization strategy and modified antiplatelet therapy may be associated with similar outcomes, or even a significant benefit compared with guidelines-recommended 12-month DAPT. This benefit could be driven by a reduced risk in significant bleeding events, while keeping a comparable protection against ischemic risk. Enrolled subjects will be randomized in a 1:1 ratio to either cessation of aspirin at 1 months, either continuation of DAPT. Selection of the P2Y12 inhibitor agent is left to investigator judgment but has to be in line with the current ESC guidelines. Subjects treated with the Firehawk or Firehawk Liberty coronary stent will be included in this study.

lead_sponsor: MicroPort CRM

location_country: Spain Italy Austria France Netherlands

location_facility:
Hospital del Mar
Clinica San Carlo
CH Chartres
CHU Clermont-Ferrand
Clinique St Hilaire
Policlinico San Donato
CHU Lille
CHU Toulouse
Clinic Hospital Barcelona
CHU Reims
Giovanni Paolo II
Hospital Universitario de Bellvitge
CHU Annecy
Policlinico Universitario
Jeroen Bosch Ziekenhuis
Clinique Pasteur
CH Haguenau
Hospital General Universitario
CH Bastia
CH Cherbourg
Niguarda
Albert Schweitzer Ziekenhuis
AOU Federico II
CHU Nîmes
CH St Joseph/St Luc
Clinique Roseraie
CHU La Timone
Universitätsklinikum
CHU Caen
CHU Montpellier
Clinica Montevergine
Maastad University Hospital
Clinique Millénaire
CHU Dijon
Tergooi MC


title: Use of the 6-minute Stepper Test to Individualise Pulmonary Rehabilitation in Patients With Severe to Very Severe Chronicle Obstructive Pulmonary Disease

summary:
Chronicle obstructive pulmonary disease is a worldwide cause of mortality and morbidity. This systemic disease progressively leads to dyspnea, muscle wasting and exercise capacity impairment.

Pulmonary rehabilitation is a cornerstone in the management of these systemic effects. Unfortunately, access to pulmonary rehabilitation is limited for many people who would benefit from it, primarily because of a lack of pulmonary rehabilitation and assessment centers. Optimal assessment should include cardiopulmonary exercise testing to determine both the optimal training settings as well as any cardiopulmonary contraindications to pulmonary rehabilitation. However, this is not available in most centers and when it is, consultations are limited. Therefore, pulmonary rehabilitation is often delayed for several weeks and patients can lose motivation.

In order to promote pulmonary rehabilitation, the incremental cardiopulmonary exercise testing could be replaced by field tests to individualize pulmonary rehabilitation prescription.

The 6-minute stepper test is a new field tool. Its sensitivity and reproducibility have previously been reported in patients with chronicle obstructive pulmonary disease. It is easy to set up in the clinical setting and could be used to individualize pulmonary rehabilitation.

The aim of this study was to develop and validate a prediction equation to set rehabilitation intensity for patients with severe to very severe chronicle obstructive pulmonary disease attending pulmonary rehabilitation, with the use of a simple, readily available field test. Therefore the investigators sought to determine, if it exists, a relationship between the plateau heart rate from the first and last 3 minutes of the 6-minute stepper test and the heart rate from the first ventilatory threshold from the cardiopulmonary exercise testing in order to individualize pulmonary rehabilitation in patients with severe to very severe chronicle obstructive pulmonary disease.

lead_sponsor: ADIR Association

location_facility: Centre Hostalier Intercommunal Elbeuf-Louviers-Val de Reuil


title: Use of the 6-minute Stepper Test to Individualise Pulmonary Rehabilitation in Patients With Mild to Moderate Chronicle Obstructive Pulmonary Disease

summary: The purpose of this study is to determine, if it exists, a relation between plateau heart rate from the last 3 minutes of the 6-minute stepper test and heart rate from first ventilatory threshold from cardiopulmonary exercise testing in order to individualise pulmonary rehabilitation in patients with mild to moderate chronicle obstructive pulmonary disease.


title: Therapeutic Evaluation of Low-dose IL-2-based Immunomodulatory Approach in Patients With Early AD

summary:
Study aims at evaluating the therapeutic efficacy and safety of low-dose IL-2 immunomodulatory treatment in patients with early AD, in a phase II, randomized, double blind, placebo-controlled phase II clinical trial. Patients with AD at early stage will be recruited and randomized (2:1) in each treatment group.

The primary endpoint is the rate of decline assessed through CDR change at 18 months between the placebo group and the treated patients.

lead_sponsor: Centre Hospitalier St Anne


title: Non-Interventional Study on Evaluation of Potential Causes of Nap Modulated Tinnitus

acronym: TinniNap

summary:
The proposed research is a non-interventional study made to evaluate different measurements on 1 group of participants, before and after taking a nap, aiming to potentially guide future investigations on nap-modulated tinnitus to better understand this phenomenon.

The main hypothesis is that sleep apneas could be correlated with an increase of tinnitus intensity.

lead_sponsor: Robin Guillard EIRL


title: Association Between Peripheral Muscle Function and Quality of Life in Obese Subjects.

acronym: OVALIA

summary:
The assessment of health status and physical function is fundamental in patients with obesity, as they play an important role among the various factors influencing the quality of life in this population. Several studies have shown an association between high BMI values and a significant deterioration in quality of life, especially in women. Excess body fat in obese patients seems to be responsible for muscle atrophy. This causal link is probably related to dysfunctions in adipose tissue, leading to a decrease in the expression of proteins responsible for muscle contraction. The recent literature highlights an alteration in quality of life, particularly in obese and elderly subjects, for which changes in muscle function are partly responsible. Changes in muscle function can be assessed by simple, rapid and non-invasive tools. They could be used to identify obese subjects at risk of they could be used to identify obese subjects at risk of muscle atrophy, to stratify the risk, and to propose prophylactic intervention or early management.

The main objective of this study is to evaluate the association between structural alteration of the quadriceps and quality of life in obese patients.

The secondary objectives are to evaluate :

The association between quadriceps thickness and quality of life ;
The association between grip strength and quality of life ;
The association between quadriceps strength and quality of life ;
The association between quadriceps strength and ultrasound measurements of the quadriceps.

This is a prospective, monocenter, observationnal and cohort study.

All outpatients for nutrition assessment will be included.

ReferenceCitation: Kim SR, Kim HN, Song SW. Associations Between Mental Health, Quality of Life, and Obesity/Metabolic Risk Phenotypes. Metab Syndr Relat Disord. 2020 Sep;18(7):347-352. doi: 10.1089/met.2020.0028. Epub 2020 May 19.


title: Prediction of Left Ventricular Function Changes Using Low Dose Dobutamine Gated SPECT in Patients Referred for Viability Assessment: The DOGS (DObutamine Gated Spect)Study.

summary:
Viability assessment remains a clinical challenge in patient with coronary artery disease and left ventricular dysfunction. Several imaging modalities are available for evaluating myocardial viability, based either on perfusion or on contractile reserve analysis. Briefly, perfusion analysis is highly sensitive and contractile reserve highly specific. A combined analysis of both perfusion and contractile reserve has been proposed to improve the diagnostic accuracy in patient referred for a revascularization procedure. However, the value of this combined analysis has not been validated in unselected patients referred for viability assessment.

The patients enrolled in the study will undergo a nitrate enhanced rest gated SPECT using a Tc-99m labeled tracer (sestamibi or tetrofosmine) followed by a second gated SPECT acquired during a low-dose dobutamine infusion (10 mcg/kg/mn). All patients will have a 6-month clinical and imaging follow-up, including physical examination and a nitrate enhanced rest gated SPECT using the same radiopharmaceutical. All treatments received during this 6-month period will be recorded, including medical therapy and coronary revascularization (angioplasty, stenting and CABG).

Finally, the value of baseline perfusion and contractile reserve analysis in predicting left ventricular ejection fraction changes at 6-month follow-up will be evaluated.

ReferenceCitation: Allman KC, Shaw LJ, Hachamovitch R, Udelson JE. Myocardial viability testing and impact of revascularization on prognosis in patients with coronary artery disease and left ventricular dysfunction: a meta-analysis. J Am Coll Cardiol. 2002 Apr 3;39(7):1151-8.

ReferenceCitation: Everaert H, Vanhove C, Franken PR. Effects of low-dose dobutamine on left ventricular function in normal subjects as assessed by gated single-photon emission tomography myocardial perfusion studies. Eur J Nucl Med. 1999 Oct;26(10):1298-303.

ReferenceCitation: Everaert H, Vanhove C, Franken PR. Effect of beta-blockade on low-dose dobutamine-induced changes in left ventricular function in healthy volunteers: assessment by gated SPET myocardial perfusion scintigraphy. Eur J Nucl Med. 2000 Apr;27(4):419-24.

ReferenceCitation: Leoncini M, Sciagrà R, Maioli M, Bellandi F, Marcucci G, Sestini S, Chiocchini S, Dabizzi RP. Usefulness of dobutamine Tc-99m sestamibi-gated single-photon emission computed tomography for prediction of left ventricular ejection fraction outcome after coronary revascularization for ischemic cardiomyopathy. Am J Cardiol. 2002 Apr 1;89(7):817-21.

lead_sponsor: University Hospital, Rouen

location_country: France Belgium

location_facility:
AZ-VUB
University Hospital of Nancy
Hopital Européen Georges Pompidou
Hopital Avicenne
Hopital Sud-Francilien
CHU de Brest
University Hospital of Caen
University Hospital of Rouen


title: Assessment of Helical Tomotherapy Radiotherapy (54 Gy) Followed by Surgery in Retro-peritoneal Liposarcoma

acronym: TOMOREP

summary:
Retro peritoneal liposarcomas are rare (less than 15% of sarcomas) whose prognosis is locoregional.

In the treatment of retroperitoneal liposarcomas main prognostic factor is the quality of the surgical resection. The effect of radiotherapy combined with surgery is uncertain and until now limited perhaps because of limited prescribed doses (of the order of 45Gy to 50Gy) due to high risk of organ toxicity nearby.

The helical tomotherapy is an innovative equipment radiotherapy to make conformational radiotherapy modulation intensity and is particularly suitable for irradiations precision (imaging mode associated with daily scanner) in large complex volumes. Increasing doses (increase of the prescribed dose to 54 Gy, thus potentially curative), the helical tomotherapy should allow to improve the efficacy of radiotherapy.

lead_sponsor: Institut Bergonié

location_facility:
Institut Bergonié
Centre Claudius Regaud
Centre René Gauducheau
Centre Paul Strauss
Institut Curie

intervention_type: Radiation


title: Study by Electroencephalography of the Link Between the Lack of Self-compassion and the Disorder of Empathy in Schizophrenia

acronym: SCE-SCHIZO

summary:
This research project focuses on a fundamental element of the psychopathology of schizophrenia, that is to say, the disorders of self-awareness and on the functional alterations associated with it, that is to say, self-compassion deficit and empathy disorder.

It will be a question of better understanding the neuro-functional mechanisms which underlie the lack of self-compassion and the disorder of empathy in schizophrenia, the relationship that these disorders maintain between them but also the relationship that they maintain with the general psychopathology of schizophrenia and, in particular, with the abnormalities of the self. In other words, the overall framework of this project is that of the link between the psychopathology of schizophrenia and the functional impairment associated with it. Its specific field of application is that of the link between self-awareness disorders, self-compassion deficit and empathy disorder. For this, this project proposes a methodological approach combining the recording of intrinsic and extrinsic brain activity using high-density electroencephalography (EEG).

lead_sponsor: Centre Hospitalier Henri Laborit


title: Role of Self-focused Attention in Depression

acronym: RFASD

summary: Using a task measuring the tracking of eye movements, the aim of this study is to demonstrate that individuals suffering from depression focus their attention more on their reflection in the screen after recalling a failure (and this all the more so as their depressive symptomatology is strong) .


title: Evaluation of the Effectiveness of a Physical Activity Program on the Severity of Narcolepsy

acronym: NARCOSPORT

summary: Narcolepsy Type 1 (NT1) is a rare chronic neurological disorder resulting from the selective loss of hypocretin neurons. Patients with NT1 suffer from excessive daytime sleepiness, disrupted nighttime sleep, and cataplexy (emotionally triggered episodes of muscle atonia). The disease is associated with numerous comorbidities such as obesity, metabolic disorders, anxiety-depressive disorders, and attentional disorders, all of which have a strong impact on quality of life.

location_facility: Service de médecine du sommeil et des maladies respiratoires


title: Comparison of PSP Values Measured With Venous Whole Blood and Those Measured With Arterial Whole Blood.

summary:
Abionic has developed a targeted, rapid test for pancreatic stone protein (PSP) in human K2-EDTA venous whole blood using the abioSCOPE instrument.

Currently no PSP study comparaison has been done between venous and arterial whole blood. Abionic would like to confirm the equivalence of the PSP between venous whole blood and arterial whole blood.

lead_sponsor: Abionic SA


title: Evaluation of a Robotic Assistance Module for Driving Electric Wheelchairs Allowing the Avoidance of Positive and Negative Obstacles on the Driving Safety of Patients With Neurological Disorders.

acronym: SWADAPT 3

summary: The device that is the subject of this investigation is a robotic assistance module for driving a semi-autonomous electric wheelchair. This module is designed to accessorize the electric wheelchair to improve the safety conditions when driving an electric wheelchair, which on the one hand reduces the accident rate of wheelchair and on the other hand and facilitates the access to the wheelchair to people who cannot claim it without the use of a safety device of this type. The robotic assistance module is programmed to detect positive and negative obstacles.

lead_sponsor: Pôle Saint Hélier


title: Evaluation of the Effects of a Cognitive-Motor Fall Prevention Program "SILVER XIII - EQUILIBRE" on Fall Risk Factors: Functional Abilities and Executive Functions

summary:
The goal of this interventional study is to compare in community dwelling elderly people the effects of two physical activity programs to prevent accident falls : "SILVER XIII EQUILIBRE" program and "VIVIFRAIL" program, on several risks factors such as executive functions and functional capacities.

Participants will perform a 1 hour physical activity session during 10 weeks and effects will be measured using a multidimensional test battery. "SILVER XIII EQUILIBRE" program contains cognitive-motor exercises where participants have to perform two tasks simultaneously such as answering math questions while walking whereas "VIVIFRAIL" program contains multifactorial exercises such as walking, balance training and resistance training in single-task condition.

The main question it aims to answer is :

• Does physical activity enriched with simultaneous cognitive exercises enhances the effects ?

ReferenceCitation: Bayard S, Erkes J, Moroni C; Collège des Psychologues Cliniciens spécialisés en Neuropsychologie du Languedoc Roussillon (CPCN Languedoc Roussillon). Victoria Stroop Test: normative data in a sample group of older people and the study of their clinical applications in the assessment of inhibition in Alzheimer's disease. Arch Clin Neuropsychol. 2011 Nov;26(7):653-61. doi: 10.1093/arclin/acr053. Epub 2011 Aug 26.

ReferenceCitation: REITAN RM. The relation of the trail making test to organic brain damage. J Consult Psychol. 1955 Oct;19(5):393-4.

ReferenceCitation: Lord SR, Fitzpatrick RC. Choice stepping reaction time: a composite measure of falls risk in older people. J Gerontol A Biol Sci Med Sci. 2001 Oct;56(10):M627-32.

ReferenceCitation: Bongue B, Dupré C, Beauchet O, Rossat A, Fantino B, Colvez A. A screening tool with five risk factors was developed for fall-risk prediction in community-dwelling elderly. J Clin Epidemiol. 2011 Oct;64(10):1152-60. doi: 10.1016/j.jclinepi.2010.12.014. Epub 2011 Apr 3.

ReferenceCitation: Fournier J, Vuillemin A, Le Cren F. Mesure de la condition physique chez les personnes âgées. Evaluation de la condition physique des seniors : adaptation française de la batterie américaine " Senior Fitness Test ". Science & Sport. 2012; 27 : 254-259.

ReferenceCitation: De Souto Barreto, P., Ferrandez, A. M., & Saliba-Serre, B. Questionnaire d'activité physique pour les personnes âgées (QAPPA): validation d'un nouvel instrument de mesure en langue française. Science and Sports. 2011; 26(1): 11-18.

ReferenceCitation: Golubic R, May AM, Benjaminsen Borch K, Overvad K, Charles MA, Diaz MJ, Amiano P, Palli D, Valanou E, Vigl M, Franks PW, Wareham N, Ekelund U, Brage S. Validity of electronically administered Recent Physical Activity Questionnaire (RPAQ) in ten European countries. PLoS One. 2014 Mar 25;9(3):e92829. doi: 10.1371/journal.pone.0092829. eCollection 2014. Erratum in: PLoS One. 2014;9(11):e114103.

lead_sponsor: EZUS-LYON 1


title: Pilot Study Evaluating the Feasibility, Usability and Functional Impact of a Wearable Grasping Neuroprosthesis Used at Home in Subjects With Post-stroke Hemiparesis

acronym: GRASP-AGAIN

summary: The study is focused on the evaluation of the feasibility, usability, acceptability, tolerance, functional impact and organizational impact of the use of a wearable prehension neuroprosthesis (innovative medical device) at home, with triggering methods specifically adapted to a population of hemiparetic post-stroke subjects. The main objective is to describe the overall therapeutic compliance represented by the number of uses of the neuroprosthesis in real-life situations.

primary_purpose: Device Feasibility


title: Transverse Study About QOL for Colostomized or Ileostomized Patients During Their Home Hospitalization

acronym: STOM'HAD

summary:
The goalf of the study is to have a basis about QOL for colo-stoma and ileo-stoma for patients which are hospitalized at home. The QOL measurement is done with a questionnaire of several items made by stomatherapist and also using EQ5D QOL form.

After reviewing of the data, our goal is to create or improve some solutions to improve their QOL during their home hospitalization.

lead_sponsor: Fondation Sante Service


title: Evaluation of the Effectiveness and Tolerance of Effaclar Ultra Concentrated Serum in Women With Mandibular Acne for 3 Months (Including 2 Months of Treatment)

summary:
The role of "dermocosmetics" in acne management is increasingly important, as many patients and even physicians now resort to them as first-line management in mild-to-moderate acne.

The aim of the study is to demonstrate the efficacy of the tested product on the appearance of acne lesions in 30 adult women suffering from acne in the mandible following an active anti-acne therapy (systemic or topical). This study includes 2 months of cosmetic treatment with EFFACLAR Ultra Concentrated Serum and one month of followup without any treatment but a moisturizer with a daily UV protection.

The investigational product has been formulated with an ultra-concentrated tri-acids complex for a synergetic action on skin and reinforced with soothing niacinamide for optimal tolerance.

This product is expected:

to leave the skin clean and smooth,
to help unblock pores,
to exfoliate dead skin cells and help the skin to appear smoother, softer and pore-less,
to be non-comedogenic.

lead_sponsor: Cosmetique Active International

location_facility: Centre de Pharmacologie Clinique Appliquée à la Dermatologie (CPCAD)


title: Inperia Advance Carbostent™ for Infra-popliteal Artery Stenosis. Evaluation of Safety and Performance in Everyday Clinical Practice: The Inperia Advance Post-Market Retrospective Study

summary: The Inperia Advance Carbostent™ is a CE-marked infra-popliteal stent for treatment of infra-popliteal artery stenosis. The aim of this post-market retrospective study protocl P32203 is to collect clinical data of patients treated with Inperia Advance for the treatment of infra-popliteal artery stenosis in routine clinical practice. In order to obtain long-term follow-up data, the data collection will be limited to patients that have been treated with the device at least 12 months prior to the study start.

lead_sponsor: CID S.p.A.


title: Impact of CErebral Endovascular PROcedures on the Systemic Immune responSe Response

acronym: PROCESS

summary: In our ICU, it could notice that patients with cerebral arterio-venous malformation (AVM) treated with embolization develop more severe Ventilator Associated Pneumoniae (VAP) compare to other patients hospitalized for neurological diseases. The Dimethylsulfoxyde (DMSO), the solvent of the embolization implant, is known to have immune effect on vitro analysis. The investigator want to prove that exposition to embolization implant for a cerebral AMV modify the cytokines production involved the system immune's regulation.

lead_sponsor: University Hospital, Limoges


title: Compliance With Medical Treatment for Endometriosis : a Cross-sectional Study

summary:
Endometriosis is defined as the presence of hormone-dependent endometrial tissue outside the uterine cavity. It is a chronic, painful and often disabling pathology during the normal activities of daily life. It affects 10% of women of childbearing age. It is therefore a real public health issue.

The latest recommendations from the HAS and the CNGOF now recommend primary medical management of endometriosis in painful women who do not wish to become pregnant. It should be remembered that until very recently, the teams resigned themselves to carrying out surgical interventions in order to support the diagnosis (this is histological and requires a biopsy) and to treat the patient if possible. Sometimes, this treatment was not possible from the outset, as the lesions appeared to be inaccessible, and additional hormonal treatment was therefore required. The current concept is to propose to patients a first hormonal suppressive treatment before a possible surgery. This therapeutic de-escalation should be considered in the light of the physiopathology of endometriosis, which is essentially based on the ovarian cycles, and indirectly on menstruation, which must then be suspended. However, a good number of patients are initially reluctant to undergo any kind of hormonal therapy, either because they have had a bad experience with hormonal contraception (intolerance) or because of a fear related to the possible complications of hormonal therapy with third or fourth generation pills, for example (thromboembolic risk). There is also a health alert at present concerning macro progestins in relation to the risk of meningioma. Acceptance of the principle of instituting amenorrhea in order to relieve patients suffering from endometriosis requires prior information. In investigator's daily practice, they frequently deplore non-compliance, which is detrimental to the proper management of the disease. The effectiveness of hormonal treatment, which will institute a quiescence of hormonal activity, is not immediate. An analgesic and anti-inflammatory treatment is then added. Investigators propose to compare the compliance of three drug strategies: analgesics alone, hormone therapy alone or hormone therapy and analgesics.

time_perspective: Cross-Sectional

lead_sponsor: Hospices Civils de Lyon

location_facility: Service de Gynécologie-Obstétrique, Sénologie et Oncologie, Hôpital Femme Mère Enfant, Hospices Civils de Lyon


title: Simultaneous Recording of Cognitive and Motor Functions After Stroke : Dissociation of Motor and Cognitive Deficits

acronym: SACSO

summary:
Aim: To assess whether a cognitively demanding dual-task has greater impact on manual dexterity in chronic stroke patients than in healthy subjects.

Methods: A visuomotor force-tracking task, combining grip force and oculomotor recordings, will be applied in chronic stroke patients with mild-moderate hemiparesis without clinical cognitive impairments and in age-comparable healthy subjects. The dual-task includes avoiding visual distractors and mental addition of numbers. Dual-task effect is calculated as difference in force control accuracy (dual minus single-task) and as difference in saccade rate (addition of numbers minus visual distractors).


title: Assessment of the Interest of ANI in the Non-communicating Patient in Palliative Care

acronym: ANI-CARE

summary:
Comfort evaluation is one of the major challenges in the palliative care setting, particularly when it comes to non-communicative patients. ANI monitoring is a non-invasive and painless technique which evaluates the parasympathetic tone activity through heart rate variability. It has proven reliable for pain assessment during general anesthesia (GA) or for sedated critically ill patients. The parasympathetic activity seems to be a good reflect of the patient's comfort, implicating stress and anxiety.

So, the ANI could be an interesting tool to assess the comfort of non-communicating end-of-life patients.

That is why the goal of our study is to assess the interest of ANI to assess the comfort of non-communicating patients hospitalized in palliative care during a painful care by comparing the ANI measure to the CPOT scale realised by the nurses in a blind manner.

lead_sponsor: University Hospital, Lille


title: Immediate Effects of STENDO on the Walking Abilities of Patients With COPD

acronym: STENDO-COPD

summary:
The STENDO process is a heart rate synchronized massage system initially validated for the treatment of lymphedema. It is a combination enveloping the lower limbs up to the abdomen. The massage system induces pressure from the ankles to the abdomen between each heartbeat. This technique would also allow an improvement of endothelial function by a greater release of nitric oxide. Thus the capacity for physical exercise is potentially improved.

The use of STENDO has never been evaluated in COPD (Chronic obstructive pulmonary disease) where physical capacity is impaired with, in particular, the presence of endothelial dysfunction. STENDO may improve walking performance. If these hypotheses are validated, the STENDO could be positioned as a complement to the exercise rehabilitation strategies offered to symptomatic COPD patients.

lead_sponsor: Elsan


title: Analysis of Empathy in Patients With Post-traumatic Stress Disorder Followed at the Hospital of Nice: Case-control Study

summary: It has been shown in the literature that the symptoms of post-traumatic stress disorder influence the quality of life of patients, in particular through the cognitive alterations they can cause. Social cognition is also itself impacted. It refers to the perception, interpretation and processing of information relating to the social environment and relationships. It is affected by the symptomatology of PTSD both in terms of the response to emotional stimuli, the perception of self and others, and the quality of intimate relationships. These elements lead to reflection on the origin of these alterations, in particular the impact of PTSD on the patient's empathy capacity, defined as the recognition and understanding of the feelings and emotions of another individual. This parameter is also little studied in the literature, only a study dating from 2010 finds a correlation between PTSD and empathy. It is in this context that the realization of a new study studying the capacity for empathy of patients with PTSD in comparison with a control group with a larger and more representative population was envisaged. The primary outcome of this study is to analyze the post-traumatic stress disorder's repercussions on empathy by passing the Interpersonal Reactivity Index (IRI) on patients in comparison with a control group. The first hypothesis is a lower total score but a higher personal distress sub-score in the PTSD population. The secondary outcomes are to describe the cofactors that can influence empathy in association or not with post-traumatic stress disorder: sociodemographic data (age, sex, education level…), traumatic event type determined through the "Inventory of Traumatogenic Events", human intervention, duration and severity of the disorder (evaluated by the Impact of Events Scale) … The number of subjects required was calculated at 19 patients and 19 controls.

lead_sponsor: Centre Hospitalier Universitaire de Nice


title: Efficacy of Alpha-blockers (Tamsulosin) in the Treatment of Symptomatic Dysuria in Multiple Sclerosis in Women

acronym: ALPHA-SEP

summary:
Multiple sclerosis (MS) is the leading non-traumatic cause of severe acquired disability in young people. The disease is defined by relapses, which can affect all neurological functions depending on the location of the new inflammatory lesion(s). The disease can thus manifest itself through bladder and bowel disorders (BWS), which affect approximately 80% of MS patients in all stages. Lower urinary tract dysfunction has a significant negative impact on the quality of life of patients and places a significant burden on the healthcare system in terms of resource allocation. In addition, there is a risk of long-term chronic renal failure, an infectious risk (recurrent cystitis and/or pyelonephritis, sometimes life-threatening) and a lithiasis risk.

The most frequently observed urinary symptoms are: urinary frequency, urgency with or without urinary incontinence, dysuria and chronic retention of urine. These disorders most often combine bladder hyperactivity and dysuria. This dysuria may be responsible for recurrent urinary tract infections, lithiasis, alteration of renal function.

The only therapeutic class currently used to treat dysuria in MS is alpha-blockers. Tamsulosin, alfusozin and doxazosin induce relaxation of the urethral smooth sphincter and prostatic urethral muscle fibers, facilitating the removal of subvesical obstruction and bladder emptying.

The study investigators hypothesize that treatment with tamsulosin 0.4 mg daily in adult MS patients with dysuria will result in symptom improvement as assessed by the International Prostate Symptom Score (IPSS) and Urinary Symptom Profile (USP) scores, a decrease in post-void residual, and an improvement in urine flow and quality of life.

lead_sponsor: Centre Hospitalier Universitaire de Nīmes


title: Image Quality of the EOSedge Radiographic System Versus a Standard Digital Radiographic (DR) System for Preoperative Assessment for Hip Replacement or Revision Surgery

acronym: PreHIPEOS

summary:
EOSedge is a precise, low dose imaging system that delivers full body, high-quality images covering the full set of musculoskeletal and orthopedic exams.

The objective of the study is to evaluate the quality of the focused pelvis/hip X-ray images on EOSedge compared to those performed on DR (current practice) to perform a preoperative radiographic evaluation of hip implant, A sufficient image quality on focused X-ray images performed on EOSedge would allow (1) to avoid the passage on two different radiographic systems (saving time) (2) to reduce the patient's x-ray radiation dose

lead_sponsor: University Hospital, Montpellier


title: Comparison of the Effects of Two Concentrations of Adrenaline (0.33 mg/l vs 1 mg/l) in the Irrigation Serum of Arthroscopic Shoulder Surgery.

acronym: PINHAR

summary:
The addition of adrenaline to the arthroscopic irrigation serum is used during rotator cuff surgery to limit intraoperative bleeding and ensure a clear view. Two concentrations of adrenaline are commonly used in practice: 1mg/L or 0.33 mg/L.

The aim of this study is to determine which of these two doses provides better clarity of the surgical field with less impact on the patient's cardiovascular parameters.

lead_sponsor: GCS Ramsay Santé pour l'Enseignement et la Recherche


title: Ultrasonographic Morphology Assessment of Low-grade Carotid Stenosis

acronym: QUAMUS

summary:
Internal carotid artery (ICA) is intended to supply blood to brain. The carotid bulb located upstream of ICA origin is prone to atherosclerosis. This is an accumulation of fat and calcium in the wall forming a plaque that gradually thickens and leads to carotid stenosis (CS), which causes a decrease in blood flow. The risk of CS is stroke caused either by carotid artery thrombosis (occlusion) or by atherosclerotic plaque fragmentation, some components of which may leak into the brain (embolism).

When diagnosing CS, an Echo-Doppler is performed to determine bulb and ICA origin obstruction rates. The reference method of quantifying CS is based on hemodynamic criteria that only allow the diagnosis of high grade stenosis thresholds (50%-70%). Below 50%, low-grade stenosis, patient follow-up is limited and could be based on morphological criteria; ultrasound imaging being a reference technique for human body structures morphological assessment, especially vessels.

Two methods of CS morphological quantification with Doppler ultrasound currently exist. Calibre reduction at the maximum of stenosis can be measured by relating the smallest luminal diameter to the vessel diameter at stenosis site (ECST method) or to the downstream ICA diameter (NASCET method). As bulb diameter measures ≈1.8 times that of ICA, ECST appears to be more suitable for CS quantification. For high-grade stenosis, morphological quantification performance is impaired due to extensive calcification of large atheromatous plaques. However, it is possible that less calcified nature of low-grade stenosis and the use of a rigorous methodology will allow reproducible assessment in routine practice. This technique has not yet been evaluated, although it is a frequent situation in patient follow-up.

lead_sponsor: Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer


title: Mobile Application (Max NEONAT) as a Clinical Support Tool for Neonatal Resuscitation in the Delivery Room: A Simulation-based Bicentric Randomized Controlled Trial.

acronym: MAXnéonat

summary: The need for neonatal cardiopulmonary resuscitation in the delivery room is rare with less than 1% of newborns requiring advanced resuscitation. The use of clinical decision support tools to guide practitioners on medical procedure steps is recognized by the medical community. In this randomized bi-centric controlled study, we investigate the effect of a mobile phone application on technical and non-technical performance of student trinomials managing simulated critical neonatal events

lead_sponsor: Erasme University Hospital


title: Evaluation of a New Navigation System in Computer-assisted Total Knee Arthroplasty

acronym: NaviKnee

summary: Evaluation of a new navigation system in computer-assisted total knee arthroplasty.


title: Orbital Solitary Fibrous Tumors: Description of a Case Series and Study of the Recurrence Rate

acronym: TFS-ORB

summary:
Orbital solitary fibrous tumors are rare tumors with an intermediate potential of malignancy. Orbital solitary fibrous tumors' prognostic criteria are still poorly understood.

Some patients with orbital solitary fibrous tumors have been treated at the Adolphe de Rothschild Foundation Hospital. This cohort will be studied to describe the recurrence rate and to identify predictive factors of recurrence or metastasis.

time_perspective: Other

lead_sponsor: Fondation Ophtalmologique Adolphe de Rothschild


title: Evaluation of Targeted Prostate Biopsies Under MRI: Tolerance and Contribution in the Therapeutic Decision - Exploratory Study

acronym: BIOPROSTATIRM

summary: The goal of this clinical trial is to assess the concordance of treatment decisions made in multidisciplinary consultation meeting based on targeted biopsies alone or targeted biopsies associated with systematic biopsies in patients with suspected prostate cancer.


title: Impact de l'incompétence Abdominale Sur l'Icontinence Urinaire Post Prostatectomie

acronym: PROSTABDO

summary: the aim of this study is assess deep abdominal wall (ultrasonography of transversus abdominis muscle) before prostatectomy, and look at one year post surgery if patient with several incontinence are the same who have dysfunction (abdominal incompetence) before the surgery.

primary_purpose: Screening

lead_sponsor: Centre Hospitalier Universitaire de Besancon


title: Effect of a New Graphically Modified Nutri-Score on the Objective Understanding of Foods' Nutritional Quality and Ultra-processing - a Randomised Controlled Trial

summary: A modified version of the Nutri-Score (Nutri-Score 2.0), containing an additional graphic mention when the product is ultra-processed, has been proposed. The investigators aim to study, in a randomised controlled trial design nested in the NutriNet-Santé cohort, the impact of this modified version on the objective understanding of foods' nutritional quality, and on the identification of UPFs as primary outcomes. They also aim to study as secondary outcomes the impact of this label on purchasing intentions and the product perceived as the healthiest.

lead_sponsor: University of Paris 13

location_facility: Equipe de recherche en Epidémiologie nutritionnelle