title: Effect of Molar Sodium Lactate Filling on Cerebral Hemodynamics in Patients With Severe Meningeal Hemorrhage Multicenter Randomized Study

summary:
Subarachnoid hemorrhage by aneurysmal rupture is a serious condition associated with a high mortality rate. Among the complications presented by these patients, vasospasm is one of the main causes of secondary aggravation, in particular the appearance of delayed neurological deficits following the induced cerebral ischemia. Classically occurring between the 4th and 12th day, with a peak on D7, its prevention is currently often ineffective.

In recent years, many studies have shown that sodium lactate could be an interesting product for neuroprotection. In addition to an anti-osmotic effect that has been demonstrated by our team in the context of post-traumatic intracranial hypertension, a metabolic action has also been observed in periods of metabolic attacks induced by brain attacks. Recently, a vasodilatory action of sodium lactate has been observed from an experimental and clinical point of view.

The purpose of this work is to observe the effect of sodium lactate, compared to placebo, on cerebral hemodynamics measured by perfusion CT (Mean Transit Time MTT) in a population of patients with hemorrhage under the arachnoid.

This work is the preliminary work of a study that will investigate the potential preventive protective effect of sodium lactate on the incidence of vasospasm.

location_facility:
Marseille Hospital
Grenoble Hospital
Nice Hospital


title: Association of Lung Bacteriobiota With Intensive Care Unit Mortality in ARDS Patients: MicroFlu Study

acronym: MicroFlu

summary: Influenza is a potentially lethal disease still responsible for thousands excess deaths both in Europe and the United States. Despite the use of neuraminidase inhibitors, its treatment is mostly based on symptomatic care. Lung microbiota has been shown to be involved in the immunity against influenza and is correlated with lung inflammation in numerous chronic respiratory diseases. We therefore aim to analyse the correlation between lung bacteriobiota and influenza ICU mortality

study_start_date_type: Anticipated

status: Unknown status

study_completion_date_type: Anticipated

study_type: Observational

time_perspective: Prospective

enrollment_type: Anticipated

ipd_sharing: No

lead_sponsor: University of Bordeaux

location_facility: Medical intensive care unit, Pellegrin hospital

location_facility: Intensive care unit, CH Francois Mitterrand

intervention_type: Diagnostic Test

lead_sponsor_type: academique

status_simplified: Unknown


status: Recruiting

primary_purpose: Treatment

acronym: TOPGUN

intervention_type: Drug

title: TOPical Sirolimus in linGUal Microcystic Lymphatic Malformation -TOPGUN

lead_sponsor: University Hospital, Tours

type: EudraCT Number

source: euctr

design_allocation: Randomized

study_start_date_type: Actual

study_type: Interventional

ReferenceType: derived

ReferenceCitation: Marchand A, Caille A, Gissot V, Giraudeau B, Lengelle C, Bourgoin H, Largeau B, Leducq S, Maruani A. Topical sirolimus solution for lingual microcystic lymphatic malformations in children and adults (TOPGUN): study protocol for a multicenter, randomized, assessor-blinded, controlled, stepped-wedge clinical trial. Trials. 2022 Jul 8;23(1):557. doi: 10.1186/s13063-022-06365-y.

location_facility: Univsersity of TOURS _ Service de Dermatologie

location_facility: REGIONAL Hospital of ORLEANS -Service de Dermatologie

summary:
Lingual microcystic lymphatic malformations (LMLMs) are rare congenital vascular malformations, presenting as clusters of cysts filled with lymph fluid or blood. They are responsible for a heavy burden even with small well-limited lesions because of oozing, bleeding, infections, or even speech, chewing or breathing impairment. Pain and aesthetic prejudice are also frequently reported. The natural history of LMLMs is progressive worsening. LMLMs complex management requires multidisciplinary care in specialised centres, and the "wait-and-see" approach is frequently used. In complicated lymphatic malformations, whatever the location, treatment with oral sirolimus, an mTOR (mammalian Target of Rapamycin) inhibitor, is often used.

Topical sirolimus is a known effective treatment for some cutaneous conditions such as angiofibromas in tuberous sclerosis. Topical applications of sirolimus on the buccal mucosae have been reported in erosive lichen planus and oral pemphigus vulgaris with good tolerance and none to slight detectable blood sirolimus concentrations.

The objective of this study is to evaluate the efficacy and safety of a 1mg/mL sirolimus solution applied once daily on mild to moderate lingual microcystic lymphatic malformation in children and adults after 4, 8, 12, 16, 20 and 24 weeks of treatment as compared to usual care (no treatment).

status_simplified: Ongoing


type: Other Identifier

title: High Resolution Retina Imaging

acronym: IHR

summary: To increase the clinical experience of using the rtx1 camera in various retinal disorders and to follow the evolution of structural alterations during retinal diseases using adaptive optics imaging with the rtx1 camera

ReferenceCitation: Paques M, Norberg N, Chaumette C, Sennlaub F, Rossi E, Borella Y, Grieve K. Long Term Time-Lapse Imaging of Geographic Atrophy: A Pilot Study. Front Med (Lausanne). 2022 Jun 22;9:868163. doi: 10.3389/fmed.2022.868163. eCollection 2022.

lead_sponsor: Centre Hospitalier National d'Ophtalmologie des Quinze-Vingts


title: Impact of Mindfulness Intervention on Quality of Life in Patients With Drug-resistant Epilepsy.

acronym: EPIMEDIT

summary:
This study evaluates a mindfulness intervention in patients with drug resistant epilepsy.

Half of participants will follow a mindfulness programme, while the other half will follow a self management programme.

primary_purpose: Other

lead_sponsor: University Hospital, Grenoble

location_facility: Epileptology Department of The Grenoble University Hospital

location_facility: Epileptology Department of the Lyon University Hospital

intervention_type: Other


title: Evaluation of the Brakes and Levers on the Use of an E-health Therapeutic Education Application for Osteoarthritis Patients

summary:
Osteoarthritis is the most common articular disease affecting the joint in a comprehensive and progressive manner. It is a chronic pathology correlated with age since nearly one in two adults is affected by osteoarthritis. The care of osteoarthritis is based on pharmacological and non-pharmacological treatment. The latest recommendations support the non-pharmacological part including regular physical activity, therapeutic education and weight loss. Today tools are lacking for the patient and the practitioner to ensure long-term motivation and support.

Connected objects, as future-oriented tools, are a customizable way to meet the expectations of both patients and professionals. The main objective of this study is to analyze the expectations regarding the use of a smartphone application for monitoring and support in the practice of exercises and regular physical activity in patients osteoarthritic.

The secondary objective is to collect information on the use of connected objects dedicated to the management of osteoarthritis by patients and health professionals.

status: Completed

study_completion_date_type: Actual

enrollment_type: Actual

lead_sponsor: University Hospital, Clermont-Ferrand

location_facility: Thermes de ROYAT - Régie Municipale des eaux minérales de Royat / SPIC

location_facility: Thermes CALEDEN - Société thermale de Chaudes Aigues

status_simplified: Completed


title: Intensive Rehabilitation Program With Intensive Visual Numerical Simulation Device for Improving Distal Motor Performance and Upper Limb Functional Capacity in Subacute Hemiparetics After Stroke. Randomized Controlled Trial.

summary:
Hemiparesis is a common motor disorder after a stroke. The majority of patients do not recover functional use of their paretic upper limb.

The use of mirror therapy allows the activation of the mirror neurons involved to stimulate brain plasticity after brain damage.The IVS (Intensive Visual Stimulation) device allows an easy implementation of mirror therapy by filming the valid upper limb and projecting the inverted image onto a screen placed above the parietal arm thus producing the illusion of movement of the parietal arm.

The main hypothesis of this study is that the structured practice of a large number of upper limb targeted movement repetitions using an intensive visual numerical simulation device as a partial replacement for routine care (conventional occupational therapy) in the sub-acute phase of stroke will increase the active function (motor function and functional abilities) of the distal end of the upper limb compared to conventional rehabilitation.

Objectives: This randomized controlled trial will evaluate the effects of partial substitution of routine care (occupational therapy) by structured movement repetition programs by Intensive Visual Simulation using an IVS3 device, on the distal motor control of the upper hemiparesis limb, between 4 and 10 weeks after the stroke, compared to a program with conventional care alone.

lead_sponsor: Clinique Les Trois Soleils

location_facility:
CRF Pasori
Clinique Les Trois Soleils
Clinalliance Villiers-sur Orge

lead_sponsor_type: industriel


title: Vitamin D3 in Sensory Recovery After Digital NERVe Suture: a Randomized Controlled Trial.

summary:
Digital nerve injuries are frequent in a FESUM center (Federation Européenne des Services d'Urgences Mains), and they need to be repaired in order to reduce the risk of hypoesthesia and to prevent painful neuroma. Several animal studies have shown that Cholecalciferol improves axonal nerve regeneration and myelination. No study has ever been done on human subjects to evaluate the nerve regeneration after Cholecalciferol supplementation.

Our hypothesis is that Cholecalciferol supplementation could improve axonal nerve regeneration and myelination after traumatic digital nerve injuries treated by microsurgical sutures and reduce the risk of hypoesthesia and neuroma.

ReferenceType: background

ReferenceCitation: al-Ghazal SK, McKiernan M, Khan K, McCann J. Results of clinical assessment after primary digital nerve repair. J Hand Surg Br. 1994 Apr;19(2):255-7.

ReferenceCitation: Alligand-Perrin P, Rabarin F, Jeudy J, Césari B, Saint-Cast Y, Fouque PA, Raimbeau G. Vein conduit associated with microsurgical suture for complete collateral digital nerve severance. Orthop Traumatol Surg Res. 2011 Jun;97(4 Suppl):S16-20. doi: 10.1016/j.otsr.2011.03.012. Epub 2011 Apr 30.

ReferenceCitation: Arnaout A, Fontaine C, Chantelot C. Sensory recovery after primary repair of palmar digital nerves using a Revolnerv(®) collagen conduit: a prospective series of 27 cases. Chir Main. 2014 Sep;33(4):279-85. doi: 10.1016/j.main.2014.05.002. Epub 2014 Jun 18.

ReferenceCitation: Barrueto F Jr, Wang-Flores HH, Howland MA, Hoffman RS, Nelson LS. Acute vitamin D intoxication in a child. Pediatrics. 2005 Sep;116(3):e453-6.

ReferenceCitation: Battiston B, Geuna S, Ferrero M, Tos P. Nerve repair by means of tubulization: literature review and personal clinical experience comparing biological and synthetic conduits for sensory nerve repair. Microsurgery. 2005;25(4):258-67. Review.

ReferenceCitation: Bertleff MJ, Meek MF, Nicolai JP. A prospective clinical evaluation of biodegradable neurolac nerve guides for sensory nerve repair in the hand. J Hand Surg Am. 2005 May;30(3):513-8.

ReferenceCitation: Chabas JF, Stephan D, Marqueste T, Garcia S, Lavaut MN, Nguyen C, Legre R, Khrestchatisky M, Decherchi P, Feron F. Cholecalciferol (vitamin D₃) improves myelination and recovery after nerve injury. PLoS One. 2013 May 31;8(5):e65034. doi: 10.1371/journal.pone.0065034. Print 2013.

ReferenceCitation: Heaney RP, Davies KM, Chen TC, Holick MF, Barger-Lux MJ. Human serum 25-hydroxycholecalciferol response to extended oral dosing with cholecalciferol. Am J Clin Nutr. 2003 Jan;77(1):204-10. Erratum in: Am J Clin Nutr. 2003 Nov;78(5):1047.

ReferenceCitation: Neubrech F, Heider S, Otte M, Hirche C, Kneser U, Kremer T. [Nerve Tubes for the Repair of Traumatic Sensory Nerve Lesions of the Hand: Review and Planning Study for a Randomised Controlled Multicentre Trial]. Handchir Mikrochir Plast Chir. 2016 Jun;48(3):148-54. doi: 10.1055/s-0042-104505. Epub 2016 Jun 16. German.

ReferenceCitation: Finnell JT, Knopp R, Johnson P, Holland PC, Schubert W. A calibrated paper clip is a reliable measure of two-point discrimination. Acad Emerg Med. 2004 Jun;11(6):710-4.

ReferenceCitation: Gueye Y, Marqueste T, Maurel F, Khrestchatisky M, Decherchi P, Feron F. Cholecalciferol (vitamin D₃) improves functional recovery when delivered during the acute phase after a spinal cord trauma. J Steroid Biochem Mol Biol. 2015 Nov;154:23-31. doi: 10.1016/j.jsbmb.2015.06.007. Epub 2015 Jul 6.

ReferenceCitation: Barger-Lux MJ, Heaney RP. Effects of above average summer sun exposure on serum 25-hydroxyvitamin D and calcium absorption. J Clin Endocrinol Metab. 2002 Nov;87(11):4952-6.

ReferenceCitation: Lundborg G, Rosén B. The two-point discrimination test--time for a re-appraisal? J Hand Surg Br. 2004 Oct;29(5):418-22. Review.

ReferenceCitation: Fakin RM, Calcagni M, Klein HJ, Giovanoli P. Long-term clinical outcome after epineural coaptation of digital nerves. J Hand Surg Eur Vol. 2016 Feb;41(2):148-54. doi: 10.1177/1753193415578986. Epub 2015 Mar 31.

ReferenceCitation: Manoli T, Schiefer JL, Schulz L, Fuchsberger T, Schaller HE. Influence of immobilization and sensory re-education on the sensory recovery after reconstruction of digital nerves with direct suture or muscle-in-vein conduits. Neural Regen Res. 2016 Feb;11(2):338-44. doi: 10.4103/1673-5374.169638.

ReferenceCitation: Montava M, Garcia S, Mancini J, Jammes Y, Courageot J, Lavieille JP, Feron F. Vitamin D3 potentiates myelination and recovery after facial nerve injury. Eur Arch Otorhinolaryngol. 2015 Oct;272(10):2815-23. doi: 10.1007/s00405-014-3305-y. Epub 2014 Sep 27.

ReferenceCitation: Pomares G, Dap F, Dautel G. Complete section of proper palmar digital pedicles: Correlation between arterial patency and sensory recovery. Hand Surg Rehabil. 2017 Apr;36(2):136-140. doi: 10.1016/j.hansur.2016.12.001. Epub 2017 Mar 9.

ReferenceCitation: Przybelski R, Agrawal S, Krueger D, Engelke JA, Walbrun F, Binkley N. Rapid correction of low vitamin D status in nursing home residents. Osteoporos Int. 2008 Nov;19(11):1621-8. doi: 10.1007/s00198-008-0619-x. Epub 2008 Apr 18.

ReferenceCitation: Romagnoli E, Mascia ML, Cipriani C, Fassino V, Mazzei F, D'Erasmo E, Carnevale V, Scillitani A, Minisola S. Short and long-term variations in serum calciotropic hormones after a single very large dose of ergocalciferol (vitamin D2) or cholecalciferol (vitamin D3) in the elderly. J Clin Endocrinol Metab. 2008 Aug;93(8):3015-20. doi: 10.1210/jc.2008-0350. Epub 2008 May 20.

ReferenceCitation: Shimokata H, Kuzuya F. Two-point discrimination test of the skin as an index of sensory aging. Gerontology. 1995;41(5):267-72.

ReferenceCitation: Shooter D. Use of two-point discrimination as a nerve repair assessment tool: preliminary report. ANZ J Surg. 2005 Oct;75(10):866-8.

ReferenceCitation: Taylor PN, Davies JS. A review of the growing risk of vitamin D toxicity from inappropriate practice. Br J Clin Pharmacol. 2018 Jun;84(6):1121-1127. doi: 10.1111/bcp.13573. Epub 2018 Apr 16. Review.

ReferenceCitation: Vieth R. Vitamin D supplementation, 25-hydroxyvitamin D concentrations, and safety. Am J Clin Nutr. 1999 May;69(5):842-56. Review.

ReferenceCitation: Vieth R. Why the optimal requirement for Vitamin D3 is probably much higher than what is officially recommended for adults. J Steroid Biochem Mol Biol. 2004 May;89-90(1-5):575-9. Review.

ReferenceCitation: Vieth R, Chan PC, MacFarlane GD. Efficacy and safety of vitamin D3 intake exceeding the lowest observed adverse effect level. Am J Clin Nutr. 2001 Feb;73(2):288-94.

ReferenceCitation: Vieth R, Pinto TR, Reen BS, Wong MM. Vitamin D poisoning by table sugar. Lancet. 2002 Feb 23;359(9307):672.

lead_sponsor: University Hospital, Caen

location_facility:
Institut de la main Nantes Atlantique
Caen University Hospital
Rouen University Hospital


title: Neuropsychological Development and Executive Functioning of Children Born to HIV- Infected Mothers

acronym: NEUROPSY-HEU

summary:
Main objective: to evaluate the executive functioning of the HIV exposed uninfected children (HEU) versus children from the same socio-economic and cultural environment, not infected or affected by HIV.

Secondary objective (s): to evaluate Intellectual Quotient, Child development, Behavior, Language and investigate link between executive functioning disorders, exposure to ARVs, HIV and family environment.

status: Active, not recruiting

design_allocation: Non-Randomized

primary_purpose: Diagnostic

ipd_sharing: Undecided

lead_sponsor: Nantes University Hospital

location_facility:
Chd Vendee
Chu Angers
Chu de Nantes


title: An Open, Multi-centre Study to Assess the Safety and Tolerability of RGTA® (OTR4132) in Patients With Acute Ischemic Stroke (AIS)

acronym: MATRISS

summary:
RGTA® (ReGeneraTing Agent) are synthetic polysaccharides mimicking extra-cellular matrix scaffold elements and protective agents called Heparan Sulphates (HSPGs).

OTR4132-MD is provided as a sterile injectable medical device. OTR4132-MD is indicated in anterior circulation acute ischemic stroke (AIS) patients re-vascularized (TICI score 2b - 3) by combined thrombolysis and endovascular thrombectomy within 6 hours of symptoms onset.

lead_sponsor: Organ, Tissue, Regeneration, Repair and Replacement

location_facility:
CHU Nancy
CHU Grenoble Alpes
CHU Bordeaux Pellegrin

intervention_type: Device


title: A First-In-Human, Single-Arm, Multi-Center, Open-Label, Repeated-Dose, Dose-Escalation Study of MP0310 in Patients With Advanced Solid Tumors

summary: To evaluate the safety and tolerability of MP0310, a DARPin® therapeutic candidate for tumor targeted activation of T cells, in patients with advanced solid tumors

lead_sponsor: Molecular Partners AG

location_facility: Institut Claudius Regaud; Institut Universitaire du Cancer Toulouse Oncopole (IUCT-O)


title: Neuroprotective, Motor and Cognitive Impact of a Long-standing Aerobic Training Program in Parkinson's Disease. A Multicenter Comparison of the Effects of Two Aerobic Programs of Graded Intensities and a Conventional Physical Therapy Program Prolonged for 9 Months on Nigrostriatal, Motor and Cognitive Functions.

acronym: AEROPROTECT

summary: In phenotypic animal models of Parkinson's Disease (PD), chronic physical exercise has produced nigrostriatal neuroprotection and symptom improvement, provided training was of high-intensity and prolonged duration (>3 months in rodent models). Conventional physical therapy in Parkinson's disease (PD) has traditionally avoided fatigue and high intensity workouts. Yet, in PD controlled studies have shown that: (i) an acute aerobic stress produces endogenous dopamine immediately after the exercise and (ii) short term (a few weeks) high intensity aerobic training enhances D2 striatal receptor density and cortical excitability and clinically improves walking, upper limb and executive functions; (iii) long-term (six months) high intensity aerobic treadmill training is associated with less deterioration of subjective UPDRS III score compared to a waiting list. Long-term high intensity aerobic training has not been compared to low or medium intensity training in PD patients for its objective motor, cognitive and putative neuroprotective effects.

ipd_sharing_description: DATAS ARE OWN BY ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS, PLEASE CONTACT SPONSOR FOR FURTHER INFORMATION

lead_sponsor: Assistance Publique - Hôpitaux de Paris

location_facility:
Sébastopol hospital
Henri Mondor Hospital
Rangueil hospital


title: Sevoflurane pharmacokInetics During Inhaled Sedation Relies on the Morphotype of ARDS in ICU Patients

acronym: SPIDERMAN

summary: The main objective of this study is to compare the pharmacokinetic models of sevoflurane-induced sedation during ARDS depending on the lung imaging phenotype (focal vs nonfocal phenotypes) The authors hypothesized that sevoflurane used for inhaled sedation could have distinct pharmacokinetic profiles depending on lung imaging phenotypes (focal vs nonfocal) during ARDS in ICU patients.

location_facility: APHP - University hospital of Saint-Louis


title: Impact of a Pharmacist-anesthesiologist Collaboration During Anesthesia Consultation on Prevention of Perioperative Medication Errors of Patients in Programmed Surgery

acronym: PREVEMCA

summary: The investigators will evaluate the efficiency of a pharmacist-anesthesiologist collaboration in the anesthetic consultation in the prevention of medical errors perioperatively in patients undergoing scheduled surgery

lead_sponsor: Centre Hospitalier Universitaire de Nīmes

location_facility:
CHU de Nimes
CHU de Montpellier
CHU de Toulouse


title: Improvement of Weaning From Mechanical Ventilation by Continuous Ultrasound Monitoring of Diaphragm Excursion: the WEAN-US Study

acronym: WEAN-US

summary:
Justification: The diaphragm is the main inspiratory muscle. Its dysfunction therefore compromises ventilation, which is necessary for gas exchange. Diaphragmatic dysfunction is frequently observed in resuscitation patients. Diaphragm ultrasound is currently a simple and validated technique for measuring the function of the diaphragm in intensive care. However, the discontinuity of the measurements is one of the major limitations of the current, standard ultrasonic evaluation of diaphragm function. Respinor AS (Oslo, Norway) has developed an ultrasound device (known as RESPINOR DXT) for continuous quantification of diaphragmatic excursion and velocity.

Aims of the study: To evaluate the feasibility of the continuous monitoring of the diaphragmatic excursion using RESPINOR DXT in patients undergoing MV in the intensive care unit, to ensure its reliability and to establish a link between the diaphragmatic excursion and the weaning outcome of MV.

Method: In addition to continuous diaphragm monitoring by RESPINOR DXT, a daily measurement of the diaphragm excursion will be performed using a conventional ultrasound system for comparison. A daily measurement of the oesophageal pressure (Pes) and the gastric pressure (Pga) will be performed, thus allowing the calculation of the transdiaphragmatic pressure (Pdi).

Analysis: The feasibility of the measurement will be evaluated through user utility questions as well as the time spent with a signal meeting specific quality criteria. Its reliability will be studied by the concordance between the measurements of the excursion measured by RESPINOR DXT and by standard ultrasound (Bland-Altman, Passing-Bablock). It will be further evaluated by the correlation between the variations of the excursion measured by RESPINOR DXT and the Pdi variations. Receiver operating characteristic (ROC) curves will be performed to identify the optimal diaphragmatic excursion threshold for predicting weaning success and prognosis.

Hypothesis: It is anticipated that the present study will show that the continuous monitoring of diaphragm excursion by RESPINOR DXT is reliable. Further, it is anticipated that there will be a statistical link between the diaphragmatic excursion and velocity of the movement measured by RESPINOR DXT before, during and after the spontaneous breathing trial.

ReferenceCitation: Jiang JR, Tsai TH, Jerng JS, Yu CJ, Wu HD, Yang PC. Ultrasonographic evaluation of liver/spleen movements and extubation outcome. Chest. 2004 Jul;126(1):179-85.

ReferenceCitation: Spadaro S, Grasso S, Mauri T, Dalla Corte F, Alvisi V, Ragazzi R, Cricca V, Biondi G, Di Mussi R, Marangoni E, Volta CA. Can diaphragmatic ultrasonography performed during the T-tube trial predict weaning failure? The role of diaphragmatic rapid shallow breathing index. Crit Care. 2016 Sep 28;20(1):305.

ReferenceCitation: Jaber S, Petrof BJ, Jung B, Chanques G, Berthet JP, Rabuel C, Bouyabrine H, Courouble P, Koechlin-Ramonatxo C, Sebbane M, Similowski T, Scheuermann V, Mebazaa A, Capdevila X, Mornet D, Mercier J, Lacampagne A, Philips A, Matecki S. Rapidly progressive diaphragmatic weakness and injury during mechanical ventilation in humans. Am J Respir Crit Care Med. 2011 Feb 1;183(3):364-71. doi: 10.1164/rccm.201004-0670OC. Epub 2010 Sep 2.

ReferenceCitation: Levine S, Nguyen T, Taylor N, Friscia ME, Budak MT, Rothenberg P, Zhu J, Sachdeva R, Sonnad S, Kaiser LR, Rubinstein NA, Powers SK, Shrager JB. Rapid disuse atrophy of diaphragm fibers in mechanically ventilated humans. N Engl J Med. 2008 Mar 27;358(13):1327-35. doi: 10.1056/NEJMoa070447.

ReferenceCitation: Kim WY, Suh HJ, Hong SB, Koh Y, Lim CM. Diaphragm dysfunction assessed by ultrasonography: influence on weaning from mechanical ventilation. Crit Care Med. 2011 Dec;39(12):2627-30. doi: 10.1097/CCM.0b013e3182266408.

ReferenceCitation: Llamas-Álvarez AM, Tenza-Lozano EM, Latour-Pérez J. Diaphragm and Lung Ultrasound to Predict Weaning Outcome: Systematic Review and Meta-Analysis. Chest. 2017 Dec;152(6):1140-1150. doi: 10.1016/j.chest.2017.08.028. Epub 2017 Aug 31. Review.

ReferenceCitation: Zambon M, Greco M, Bocchino S, Cabrini L, Beccaria PF, Zangrillo A. Assessment of diaphragmatic dysfunction in the critically ill patient with ultrasound: a systematic review. Intensive Care Med. 2017 Jan;43(1):29-38. doi: 10.1007/s00134-016-4524-z. Epub 2016 Sep 12. Review.

ReferenceCitation: Farghaly S, Hasan AA. Diaphragm ultrasound as a new method to predict extubation outcome in mechanically ventilated patients. Aust Crit Care. 2017 Jan;30(1):37-43. doi: 10.1016/j.aucc.2016.03.004. Epub 2016 Apr 22.

lead_sponsor: Respinor AS

location_facility:
CHU Angers
CH Saint Joseph Saint Luc
Hôpital Universitaire Pitié Salpêtrière


title: RElevance of UltraSonography for Assessing Salivary Gland Involvement in Systemic Sclerosis (SSc)

acronym: REUSSI-SSc

summary: As fibrosis of salivary glands is supposed to be the main mechanism involved in Systemic sclerosis (SSc)-associated sicca syndrome, Ultrasonography , biopsy and measuring gland elasticity (by ARFI (Acoustic Radiation Force Impulse)) in SSc patients could also constitute a relevant method to assess the potential alterations of echostructure of major salivary glands and the fibrosis of Salivary Glands in this disease.

ReferenceCitation: Salaffi F, Argalia G, Carotti M, Giannini FB, Palombi C. Salivary gland ultrasonography in the evaluation of primary Sjögren's syndrome. Comparison with minor salivary gland biopsy. J Rheumatol. 2000 May;27(5):1229-36.

ReferenceCitation: Hocevar A, Ambrozic A, Rozman B, Kveder T, Tomsic M. Ultrasonographic changes of major salivary glands in primary Sjogren's syndrome. Diagnostic value of a novel scoring system. Rheumatology (Oxford). 2005 Jun;44(6):768-72. Epub 2005 Mar 1.

ReferenceCitation: Milic VD, Petrovic RR, Boricic IV, Radunovic GL, Pejnovic NN, Soldatovic I, Damjanov NS. Major salivary gland sonography in Sjögren's syndrome: diagnostic value of a novel ultrasonography score (0-12) for parenchymal inhomogeneity. Scand J Rheumatol. 2010 Mar;39(2):160-6. doi: 10.3109/03009740903270623.

ReferenceCitation: Jousse-Joulin S, Milic V, Jonsson MV, Plagou A, Theander E, Luciano N, Rachele P, Baldini C, Bootsma H, Vissink A, Hocevar A, De Vita S, Tzioufas AG, Alavi Z, Bowman SJ, Devauchelle-Pensec V; US-pSS Study Group. Is salivary gland ultrasonography a useful tool in Sjögren's syndrome? A systematic review. Rheumatology (Oxford). 2016 May;55(5):789-800. doi: 10.1093/rheumatology/kev385. Epub 2015 Dec 14. Review.

ReferenceCitation: Cornec D, Jousse-Joulin S, Pers JO, Marhadour T, Cochener B, Boisramé-Gastrin S, Nowak E, Youinou P, Saraux A, Devauchelle-Pensec V. Contribution of salivary gland ultrasonography to the diagnosis of Sjögren's syndrome: toward new diagnostic criteria? Arthritis Rheum. 2013 Jan;65(1):216-25. doi: 10.1002/art.37698.

lead_sponsor: Rennes University Hospital

location_facility:
CHU Brest Service de Rhumatologie
CHU rennes
CHU Tours, Service de médecine interne


title: Optimizing Long-term Survival in Organ Transplantation: From Physiopathology to Optimized Patient Management

acronym: BIOSUPORT

summary:
Increased indications for transplantation continue to worsen the shortage of organs and need the extension of graft sampling criteria and the search for new potential sources of organs. Despite undeniable success in the short term, due to major advances in surgery, medicine and research, transplant recipients continue to face the risk of chronic rejection and long-term complications.

The University Hospital Federation (UHF) "SUPORT" was created to optimize the chances of success of the organ transplant and improve the quality of life of the transplanted patient. UHF SUPORT 's ambition is based on a translational strategy that presents two priority areas:

Axis 1: Optimization, evaluation, conditioning of the donor, graft, recipient Axis 2: Personalized follow-up of the transplanted patient in the short and long term Identifying factors for long-term graft and patient survival through translational research from a common cohort and biological collection will predict transplant rejection, prolong graft function, or improve the patient's care.

lead_sponsor: University Hospital, Limoges

location_facility:
Limoges hospital
Poitiers Hospital
Tours hospital


title: Patterns of Care and Outcomes of Patients With METAstatic Soft Tissue SARComa in a Real-life Setting: the METASARC Observational Study

acronym: METASARC

summary:
Well-designed observational studies of individuals with rare tumors are needed to improve patient care, clinical investigations, and the education of healthcare professionals.

The patterns of care, outcomes, and prognostic factors of a cohort of 2225 patients with metastatic soft tissue sarcomas who were diagnosed between 1990 and 2013 and documented in the prospectively maintained database of the French Sarcoma Group will be analyzed with a focus on : number/frequency of systemic treatments per patient, number/frequency of patients with locoregional treatment of the metastasis, number/frequency of patients with chemotherapy, number/frequency of patients with an off-label drug.

Outcome (time-to-next treatment [TNT] and overall survival [OS]) will be reported according to histological subtype, as well as the association between TNT and OS.

Prognostic factors of OS will be investigated.

time_perspective: Retrospective

ReferenceType: result

ReferenceCitation: Savina M, Le Cesne A, Blay JY, Ray-Coquard I, Mir O, Toulmonde M, Cousin S, Terrier P, Ranchere-Vince D, Meeus P, Stoeckle E, Honoré C, Sargos P, Sunyach MP, Le Péchoux C, Giraud A, Bellera C, Le Loarer F, Italiano A. Patterns of care and outcomes of patients with METAstatic soft tissue SARComa in a real-life setting: the METASARC observational study. BMC Med. 2017 Apr 10;15(1):78. doi: 10.1186/s12916-017-0831-7.

lead_sponsor: Institut Bergonié

location_facility: Institut Bergonié, Comprehensive Cancer Center

location_facility: Institut Gustave Roussy, Comprehensive Cancer Center

location_facility: Centre Léon Bérard, Comprehensive Cancer Center


title: Multicenter Open Pilot Study for the Use Smartphone Application to Prevent Suicidal Relapse Among 15-35 Years-old With Previous Suicide Attempted

acronym: MED COMPANION

summary:
Context: Suicide is the 2nd cause of death during adolescence Compliance with post SA care is low and variable with effective compliance ranging from 17.5% to 47% . Therefore, prevention programs should also focus on high-risk individuals with a previous history of SA.

Adolescents and young adults are considered to be digital natives, they are therefore a relevant population for the testing of Smartphone Application.

Project: The Investigators propose an innovative and new approach to prevent SA and Suicide for patients, based on a mobile healthcare application.

The program is an add-on to the usual care process.

Study: In a multicentric randomized pilot study with 15 to 35 years-old patients having previous SA, the primary goal for pilot study is to observe the filling rate of the application (feasibility).

primary_purpose: Prevention

ReferenceCitation: Mouchabac S, Leray P, Adrien V, Gollier-Briant F, Bonnot O. Prevention of Suicidal Relapses in Adolescents With a Smartphone Application: Bayesian Network Analysis of a Preclinical Trial Using In Silico Patient Simulations. J Med Internet Res. 2021 Sep 30;23(9):e24560. doi: 10.2196/24560.

location_facility:
CH Poitiers
CHU d'Angers
CH Rennes


title: Regulatory T-cell Induction by Low-dose Interleukin-2 in Women With Unexplained Repeated Spontaneous Early Miscarriages

summary: The purpose of this study is to demonstrate the ability of low dose IL-2 to stimulate peripheral blood Tregs of women with unexplained repeated early spontaneous miscarriages for development of a therapy to prevent fetal rejection by low dose IL-2.

location_facility: Bornes Mekinian Kayem


title: A Phase I Clinical Study Evaluating the Safety of Peptide Receptor Radionuclide Therapy (PRRT) With 177Lu-DOTA0-Tyr3-Octreotate in Children With Refractory or Recurrent Neuroblastoma Expressing Somatostatin Receptors.

acronym: NEUROBLU 02

summary:
This study is a multicenter, open label phase I dose escalation trial designed to define the Maximum Tolerated Dose (MTD) of 177Lu-DOTATATE in children with refractory or recurrent neuroblastoma.

177Lu-DOTATATE will be delivered intravenously for 2 cycles, 6 weeks apart.

The duration of study participation of each patient will be 5 months.

status: Not yet recruiting

lead_sponsor: Institut Claudius Regaud

location_facility:
Centre Léon Bérard
Centre Oscar Lambret
IUCT-O


title: Deciphering Mechanisms Underlying Cancer Immunogenicity

acronym: DECIDE

summary:
This trial is a translational, open-label, multicentric, prospective cohort study of 900 patients aiming to describe the PD-1 (programmed death) expression in T cells (T lymphocytes) in different solid tumors.

The study will be conducted on a population of patients with local and/or metastatic malignant solid tumor and who are followed within a standard of care procedure or clinical trial.

Patients with any of the following tumor types may be enrolled in the trial:

Head and neck cancer,
Ovarian cancer,
Cervical cancer,
Pre-invasive CIN III cervical cancer (Cervical Intra-epithelial Neoplasia III cervical cancer),
Other solid tumor types (including glioblastoma, NSCLC (Non-small cell lung cancer), anal cancer)

Each tumor type will be considered as an independent cohort.

For each included patient, biological specimen (tumor sample, blood samples and ascites samples if applicable) will be collected.

Study participation of each patient will be 5 years.

location_facility: Institut Universitaire du Cancer Toulouse - Oncopole


title: Evaluation of the Quality of Life and Sexuality of Patients Over 65 Years of Age Undergoing Adjuvant Treatment for Breast Cancer

acronym: QUALITY-AGE

summary: The purpose of this study is to assess the quality of life and sexuality during adjuvant chemotherapy in over 65 years old patients with breast cancer

lead_sponsor: Centre Henri Becquerel

location_facility:
Centre François Baclesse
CHU Amiens
Centre Henri Becquerel


title: OCTA Versus Structural OCT: Quantitative OCTA Biomarkers of Remission in Neovascular AMD

acronym: QUAOBARE

summary: The objective is to find if there is a relationship between the Fractal Dimension, the gap, vascular density (VD), the surface, the span ratio and the status of the choroidal neovessels to adjust the interval between 2 intravitreal injections nor on the qualitative aspect of Optical Coherence Structural Tomography but also on quantified quantitative and objective values.

lead_sponsor: Centre Hospitalier Intercommunal Creteil

location_facility: Centre d'exploration ophtalmologique de l'odéon


title: Psychological and Social Determinants of Physical Activity Practice From Diagnose to Survival Among French Cancer Patients

acronym: PERTINENCE

summary: The litterature has demonstrates that physical activity can play an important role in decreasing patient mortality rates and increasing its well-being at all time of cancer. Despite this evidence, there is a weak adhesion in patients. It is therefore appropriate to look and see which may explain the high prevalence of physical inactivity in patients with cancer. The main objective of this study will be to recognize psychological and social factors which could explain the commitment or not to a physical activity in cancer patients. Besides the physical limitations related to the cancer and its treatment, socio-economic and psycho-social factors can often play an extremely important role in engagement or maintenance of sporting activity.

ReferenceCitation: Van Hoye A, Omorou Y, Rotonda C, Gendarme S, Tarquinio C, Houtmann B, Peiffert D, Longo R, Martin-Krumm C. Psychological and social determinants of physical activity from diagnosis to remission among French cancer patients (PERTINENCE): protocol for a mixed-method study. BMC Public Health. 2019 Aug 6;19(1):1053. doi: 10.1186/s12889-019-7368-y.

lead_sponsor: Institut de Cancérologie de Lorraine

location_facility:
CHR Metz Thionville
Institut de Cancérologie de Lorraine


title: Role of the NLRP3 Inflammasome in Escherichia Coli and Staphylococcus Aureus Bacteria

summary: Our previous studies delineate a novel pathway of immune activation in animals that the investigators have named Anti-Virulence Immunity (AVI). Using a mice model of bacteremia, the investigators have demonstrated that Escherichia coli Cytotoxic Necrotizing Factor 1 (CNF1) activity is sensed by the immune system. This immune sensing results in a rapid bacterial clearing during bacteremia triggered by uropathogenic E. coli-expressing CNF1. The investigators already confirmed the involvement of one inflammasome using macrophages isolated from Knock-out mice. The investigators have recently determined the conservation in human monocytes of the interleukin -1beta maturation triggered by CNF1 and observed the heterogeneous capacity of monocytes to respond to the CNF1 treatment depending on the donors. Here, to determine the importance in natura of AVI the investigators will analyze the blood content of patients presenting E. coli and S. aureus bacteremia. The DNA of monocytes isolated from patients will be extracted and various genes implicated in the activity of various inflammasomes will be sequenced to identify mutations that could explain the susceptibility to bacteremia or a specific clinical presentation, i.e. requirement of a management in ICU because of organ failure.

ReferenceCitation: Lee CC, Chen SY, Chang IJ, Chen SC, Wu SC. Comparison of clinical manifestations and outcome of community-acquired bloodstream infections among the oldest old, elderly, and adult patients. Medicine (Baltimore). 2007 May;86(3):138-44. Erratum in: Medicine (Baltimore). 2013 Jul;92(4):216.

ReferenceCitation: Weinstein MP, Towns ML, Quartey SM, Mirrett S, Reimer LG, Parmigiani G, Reller LB. The clinical significance of positive blood cultures in the 1990s: a prospective comprehensive evaluation of the microbiology, epidemiology, and outcome of bacteremia and fungemia in adults. Clin Infect Dis. 1997 Apr;24(4):584-602.

ReferenceCitation: Wisplinghoff H, Bischoff T, Tallent SM, Seifert H, Wenzel RP, Edmond MB. Nosocomial bloodstream infections in US hospitals: analysis of 24,179 cases from a prospective nationwide surveillance study. Clin Infect Dis. 2004 Aug 1;39(3):309-17. Epub 2004 Jul 15. Erratum in: Clin Infect Dis. 2004 Oct 1;39(7):1093. Clin Infect Dis. 2005 Apr 1;40(7):1077.

ReferenceCitation: Vallés J, Palomar M, Alvárez-Lerma F, Rello J, Blanco A, Garnacho-Montero J, Martín-Loeches I; GTEI/SEMICYUC Working Group on Bacteremia. Evolution over a 15-year period of clinical characteristics and outcomes of critically ill patients with community-acquired bacteremia. Crit Care Med. 2013 Jan;41(1):76-83. doi: 10.1097/CCM.0b013e3182676698.

ReferenceCitation: Herrmann JB, Muenstermann M, Strobel L, Schubert-Unkmeir A, Woodruff TM, Gray-Owen SD, Klos A, Johswich KO. Complement C5a Receptor 1 Exacerbates the Pathophysiology of N. meningitidis Sepsis and Is a Potential Target for Disease Treatment. mBio. 2018 Jan 23;9(1). pii: e01755-17. doi: 10.1128/mBio.01755-17.

lead_sponsor: Centre Hospitalier Universitaire de Nice

location_facility:
CHU de Lenval
CH Pierre Nouveau
CHG d'Antibes

intervention_type: Genetic


acronym: DUPECZEMAIN

title: DUPECZEMAIN : Double Blind Placebo-controlled Randomized Multicenter Study Assessing the Efficacy and Safety of Dupilumab in Moderate to Severe Chronic Hands Eczema Refractory to Highly Potent Topical Corticosteroids

lead_sponsor: University Hospital, Toulouse

ReferenceCitation: Halioua B. [Hand eczema : disability and impact]. Ann Dermatol Venereol. 2014 Jun;141 Suppl 1:S111-6. doi: 10.1016/S0151-9638(14)70148-6. Review. French.

ReferenceCitation: Cortesi PA, Scalone L, Belisari A, Bonamonte D, Cannavò SP, Cristaudo A, De Pità O, Gallo R, Giannetti A, Gola M, Pigatto PD, Mantovani LG. Cost and quality of life in patients with severe chronic hand eczema refractory to standard therapy with topical potent corticosteroids. Contact Dermatitis. 2014 Mar;70(3):158-68. doi: 10.1111/cod.12130. Epub 2013 Sep 19.

ReferenceCitation: Fowler JF, Graff O, Hamedani AG. A phase 3, randomized, double-blind, placebo-controlled study evaluating the efficacy and safety of alitretinoin (BAL4079) in the treatment of severe chronic hand eczema refractory to potent topical corticosteroid therapy. J Drugs Dermatol. 2014 Oct;13(10):1198-204.

ReferenceCitation: Blauvelt A, de Bruin-Weller M, Gooderham M, Cather JC, Weisman J, Pariser D, Simpson EL, Papp KA, Hong HC, Rubel D, Foley P, Prens E, Griffiths CEM, Etoh T, Pinto PH, Pujol RM, Szepietowski JC, Ettler K, Kemény L, Zhu X, Akinlade B, Hultsch T, Mastey V, Gadkari A, Eckert L, Amin N, Graham NMH, Pirozzi G, Stahl N, Yancopoulos GD, Shumel B. Long-term management of moderate-to-severe atopic dermatitis with dupilumab and concomitant topical corticosteroids (LIBERTY AD CHRONOS): a 1-year, randomised, double-blinded, placebo-controlled, phase 3 trial. Lancet. 2017 Jun 10;389(10086):2287-2303. doi: 10.1016/S0140-6736(17)31191-1. Epub 2017 May 4.

ReferenceCitation: Molin S, Merl J, Dietrich KA, Regauer M, Flaig M, Letulé V, Saucke T, Herzinger T, Ruzicka T, Hauck SM. The hand eczema proteome: imbalance of epidermal barrier proteins. Br J Dermatol. 2015 Apr;172(4):994-1001. doi: 10.1111/bjd.13418. Epub 2015 Feb 26.

location_facility:
Larrey Hospital
Hôpital Saint Eloi
Saint André Hospital

summary: Dupilumab has recently demonstrated high efficacy and good safety profile in the treatment of moderate-to-severe atopic dermatitis. There is a crucial need of developing new treatment options in Chronic hand eczema refractory to topical therapy. Investigators hypothesise that Dupilumab will also have high efficacy and good safety profile in the treatment of moderate to severe Chronic hand eczema refractory to highly potent topical corticosteroids.


title: Multiple Sclerosis in the Elderly: Epidemiology, Clinical and MRI Characteristics

acronym: OLDMUS

summary:
Little is known about old MS patients. In a previous work, systematic search in Bordeaux, Strasbourg and Dijon university hospital regional MS center databases European Database for Multiple Sclerosis (EDMUS) retrieved 2% of 75 years old or older Multiple Sclerosis (MS) patients in the 3 databases. Data analysis showed that MS may switch off in the very old patients with mild progression and very few relapses. The project is to continue this preliminary work and extend it with a systematic study of MS in the elderly.

The scientific aims: To add new insights into long lasting MS natural history in the growing population of elderly patients with MS.

lead_sponsor: University Hospital, Bordeaux

location_facility: CHU de Bordeaux - Pellegrin - service de neurologie

location_facility: Hôpital neurologique - Pierre Wertheimer


title: SAlt Diet and Various Biomarkers Effects on Blood Pressure and Proteinuria During Inhibition of VEGF)

acronym: SAVE

summary:
Bevacizumab is an anti-angiogenic treatment used to treat various solid cancers. Previous studies have shown that this treatment may have adverse effects like hypertension and proteinuria.

This is an exploratory study aiming to better understand the relationship between various biomarkers and blood pressure changes and proteinuria measured for 4 to 6 weeks after the first infusion of anti-VEGF therapy with bevacizumab.

lead_sponsor: University Hospital, Tours

location_facility: Medical Oncology Service, University Hospital, Tours

location_facility: Oncological Gastroenterology Service, University Hospital, Tours


title: High-Flow Nasal Oxygenation Versus Standard Oxygenation in Gastrointestinal Endoscopy With Sedation. A Prospective Multicenter Randomized Study

acronym: ODEPHI

summary: This study is a randomized controlled trial comparing high-flow nasal oxygen therapy (HFNO) versus standard oxygen therapy (nasal prongs, nasopharyngeal catheter or standard face mask) during gastrointestinal (GI) endoscopy with sedation to reduce the incidence of hypoxia.

ReferenceCitation: Qadeer MA, Lopez AR, Dumot JA, Vargo JJ. Hypoxemia during moderate sedation for gastrointestinal endoscopy: causes and associations. Digestion. 2011;84(1):37-45. doi: 10.1159/000321621. Epub 2011 Feb 8.

ReferenceCitation: Qadeer MA, Rocio Lopez A, Dumot JA, Vargo JJ. Risk factors for hypoxemia during ambulatory gastrointestinal endoscopy in ASA I-II patients. Dig Dis Sci. 2009 May;54(5):1035-40. doi: 10.1007/s10620-008-0452-2. Epub 2008 Nov 12.

ReferenceCitation: Cohen LB, Wecsler JS, Gaetano JN, Benson AA, Miller KM, Durkalski V, Aisenberg J. Endoscopic sedation in the United States: results from a nationwide survey. Am J Gastroenterol. 2006 May;101(5):967-74.

ReferenceCitation: Griffin SM, Chung SC, Leung JW, Li AK. Effect of intranasal oxygen on hypoxia and tachycardia during endoscopic cholangiopancreatography. BMJ. 1990 Jan 13;300(6717):83-4.

ReferenceCitation: Woods A, Sanowski RA, Wadas DD, Manne RK, Friess SW. Eradication of diminutive polyps: a prospective evaluation of bipolar coagulation versus conventional biopsy removal. Gastrointest Endosc. 1989 Nov-Dec;35(6):536-40.

ReferenceCitation: Nay MA, Fromont L, Eugene A, Marcueyz JL, Mfam WS, Baert O, Remerand F, Ravry C, Auvet A, Boulain T. High-flow nasal oxygenation or standard oxygenation for gastrointestinal endoscopy with sedation in patients at risk of hypoxaemia: a multicentre randomised controlled trial (ODEPHI trial). Br J Anaesth. 2021 Jul;127(1):133-142. doi: 10.1016/j.bja.2021.03.020. Epub 2021 Apr 28.

ReferenceCitation: Eugene A, Fromont L, Auvet A, Baert O, Mfam WS, Remerand F, Boulain T, Nay MA. High-flow nasal oxygenation versus standard oxygenation for gastrointestinal endoscopy with sedation. The prospective multicentre randomised controlled ODEPHI study protocol. BMJ Open. 2020 Feb 18;10(2):e034701. doi: 10.1136/bmjopen-2019-034701.

lead_sponsor: Centre Hospitalier Régional d'Orléans

location_facility:
Hospital Center of DAX
Orleans Hospital Center
Pole santé ORELIANCE


title: Prospective Evaluation of the Efficacy and Safety of a Simplified Procedure for the Percutaneous Closure of the Patent Foramen Ovale

acronym: IDFFOP

summary:
Patent Foramen Ovale, is an embryonic remnant, formed by apposition of the septum primum and septum secondum composing the interatrial septum. This foramen ovale is permeable during intra-uterine life and allows inter-auricular communication. It tends to close at birth, due to increased pressure from the left atrium. However, it remains permeable in almost 25% of the general population. Several studies have shown that this cardiac "anomaly" associated with the atrial septum aneurysm (ASA), easily diagnosed by ultrasound, is more common in patients with cryptogenic stroke. The diagnosis of patent foramen ovale is performed by a cardiac ultrasound with a "bubble" test: a volume of micro-bubbles obtained by emulsion of saline (9 ml) and air (1 ml) is injected intravenously. The path of these microbubbles is observed by trans-thoracic ultrasound and can detect a shunt right / left. This test can be sensitized by Valsalva maneuver and / or cough. The shunt is quantified by the number of microbubbles flowing through the right / left shunt: positive diagnosis: more than 3 bubbles passing; minimal shunt <10 bubbles, moderate shunt between 10 and 30 bubbles, massive shunt if> 30 bubbles.

Patent Foramen Ovale Closure is an interventional cardiac catheterization procedure by venous femoral approach. Several clinical trials show that Patent Foramen Ovale closure prevents stroke recurrence in young people and that this procedure is more effective than antiplatelet therapy. Nevertheless, an increase in the incidence of peri-procedural atrial fibrillation has been observed. For some researchers, this would be explained by irritation of the atrial muscle due to the establishment of the device.

To date, only percutaneous closures made in clinical trials have been evaluated. In fact, there are no specific recommendations. The use in clinical practice of this percutaneous treatment therefore requires an evaluation of the indications but also the profile of the patients to optimize these procedures and reduce the complication rate.

The closure technique and the choice of the size of the prosthesis are not standardized. The closure is done under trans-esophageal echocardiography (invasive method) or trans-thoracic echocardiography (non-invasive method) depending on the choice of the practitioner. In CLOSE study, this rate is not specified. The procedure rate under general anesthesia is 54%. This category of patients can be assumed to use a trans-esophageal echocardiography.

The absence of specific recommendations concerning the technical modalities of this procedure lead us to study the closure of Patent Foramen Ovale standardized under trans-thoracic echocardiography and to evaluate its possible reliefs by avoiding the general anesthesia and the use of trans-esophageal echocardiography. The objective of the study is to bring elements of standardization of the technique. As part of a "real life" study, we will evaluate the success rate of procedure under local anesthesia and under trans-thoracic echocardiography control. This evaluation will be done by trans-thoracic echocardiography at 3 months, the re-endothelisation time of the medical device being between 1 and 3 months.

lead_sponsor: Groupe Hospitalier Paris Saint Joseph

location_facility:
Groupe Hospitalier Paris Saint-Joseph
Centre Chirurgical Marie Lannelongue
Centre Cardiologique du Nord


title: Implementation and Impact of Multidisciplinary Medication Review in Surgery Departments on Medication Management of Elderly Patients

acronym: CHIROPMEV

summary: The presence of a clinical pharmacist (for their pharmacological expertise) and a general practitioner (for their somatic expertise) in surgery departments would contribute to improve the management of medications in elderly patients.

location_facility:
Nimes University Hospital
CHU de Montpellier
CHU de Toulouse


title: Evaluation of the Mobility of the Digital Flexor Tendons Operated by Dynamic MRI: a Pilot Study.

acronym: DynamicMRI

summary: To study flexor tendon excursion in the hand after surgery by dynamic MRI

ipd_sharing: Yes

ipd_sharing_description: All collected data that underlie results in a publication

lead_sponsor: University Hospital, Brest

location_facility:
HIA
Clinique Keraudren
CHRU de Brest


title: Evaluation of the Efficacy of Stiripentol (Diacomit) as Monotherapy for the Treatment of Primary Hyperoxaluria

summary:
Evaluation of the efficacy of stiripentol (Diacomit) as monotherapy for the treatment of primary hyperoxaluria.

Pilot clinical study, open, prospective and multicenter.

lead_sponsor: Biocodex

location_facility:
Hôpital Robert Debré
Hôpital Tenon
Hôpital Necker


title: Study of Exosomes in Monitoring Patients With Sarcoma (EXOSARC)

acronym: EXOSARC

summary:
Sarcomas are rare cancers with a high risk of metastatic progression and a major pejorative factor with respect to patient survival. The estimation of the metastatic risk of sarcomas is very complex given the histological heterogeneity of this entity. It is therefore essential that, at diagnosis, a reliable evaluation of this metastatic potential be made, in order to adapt the therapeutic strategy as well as possible.

It has recently been discovered that sarcomas secrete many exosomes that appear to play an important role in tumorogenesis, growth, tumor progression and the onset of metastases. They contain many proteins and nucleic acids (DNA, RNA, microRNA), reflecting the characteristics of the tumor. It has been shown that the amount of exosomes can be correlated with the grade of malignancy of the tumor. Present in the blood, exosomes offer the possibility of non-invasively analyzing the molecular information of the cancer cell. As a result, the study of serum exosomes derived from sarcomas has a high potential as a liquid biopsy to evaluate cancer pathogenesis, progression, and treatment efficacy.

The purpose of this study is to demonstrate in patients with sarcomas that exosomes can be used to monitor their disease and be used as a predictor of the risk of recurrence.

lead_sponsor: Centre Georges Francois Leclerc

location_facility:
Centre Georges François Leclerc
CHU de Besançon
CHU de Poitiers

intervention_type: Biological


title: Comparison of the Acute Hemodynamic Effect of Three Modes of Stimulation in Cardiac Resynchronization.

acronym: 3 STIM

summary:
Cardiac Resynchronization Therapy (CRT) is an established treatment for patients with systolic heart failure and bundle branch block, improving functional capacity, quality of life and reducing morbi-mortality.

Adjusting atrio-ventricular (AV) delay, vector optimization and choice of different modes of stimulation can influence the acute hemodynamical consequences of CRT but also its medium-term and long-term clinical and echocardiographic effects.

The aim of the present prospective study is to investigate whether the different stimulation modes lead to different acute hemodynamic response, by evaluating the highest systolic pressure using the Finapress ® method.

status: Terminated

ReferenceCitation: Ferchaud V, Garcia R, Bidegain N, Degand B, Milliez P, Pezel T, Moubarak G. Non-invasive hemodynamic determination of patient-specific optimal pacing mode in cardiac resynchronization therapy. J Interv Card Electrophysiol. 2021 Nov;62(2):347-356. doi: 10.1007/s10840-020-00908-6. Epub 2020 Oct 30.

lead_sponsor: CMC Ambroise Paré

location_facility:
CHU Poitiers
Gehm Site D'Eaubonne
Cmc Ambroise Pare


title: French Cohort on the Becoming of Recent Articular Psoriatic Rheumatism (A Psoriatic Arthritis CoHort)

acronym: APACHE

summary:
Psoriatic arthritis (PsA) is a chronic inflammatory rheumatic disease, belonging to the wide spectrum of spondyloarthritis, but with the particularity to be associated with personal psoriasis or familial psoriasis. PsA can be a very disabling disease through progressive and irreversible joint damage. Long-term functional prognosis of patients with PsA is correlated with the presence and severity of the radiographic joint lesions of the disease.

However, the proportion of patients who will develop those peripheral joint damages is not yet known and less over the factors which are associated/involved in such an aggressive pattern of the disease. Early identification of this subgroup of patients is particularly important for determining early "intensive" treatment, strict management with a Treat To Target approach, and identification of new treatments with a stronger structural effect.

The main objective of this prospective 10 years cohort is to describe the 5 years structural (radiographic) severity of recent PsA with recent peripheral arthritis.Some of the secondary objectives are to describe the 10 years structural severity within those patients, and to determine the predictive factors of those 5 and 10 years radiographic lesions (genetic, environmental, clinic, therapeutic factors).

APACHE will provide a unique longitudinal standardized database concerning patients with PsA with very recent peripheral arthritis. Research projects which will based on those collected data should allow to identify the mechanisms of aggressive joint damage, to highlight mew treatments targets, to better describe the burden of the disease, to test previous or develop new assessments tolls, to develop early diagnostic criteria

lead_sponsor: Assistance Publique - Hôpitaux de Paris

location_facility:
Lapeyronie Hospital
Henri-Mondor Hospital
Saint Joseph Hospital


title: Effects of Obstructive Sleep Apnea on the Frequency of Vaso-occlusive Crises Events and Bio-physical Markers in Sickle Cell Disease

acronym: DREPAPNEE

summary: Despite the fact that obstructive sleep apnoea (OSA) is highly prevalent in the sickle cell population, studies focusing on the associations of the two diseases and their common pathophysiological mechanisms are scarce. OSA is one of the most common conditions responsible for hemoglobin desaturation. The nocturnal hemoglobin desaturation occurring in some sickle cell disease (SCD) patients with OSA could trigger hemoglobin S polymerization and red blood cell (RBC) sickling, leading to further blood rheological alterations, hence increasing the risks for VOC. Moreover, OSA has been demonstrated to increase oxidative stress and inflammation in non Sickle Cell Disease (SCD) patients, which, in SCD patients, could increase the risk for complications. Finally, OSA is accompanied by impaired vascular function and autonomic nervous system dysfunction in the general population. Indeed, the presence of OSA in SCD could increase the clinical severity of patients and the frequency of VOC.

primary_purpose: Basic Science

ReferenceCitation: Stauffer E, Poutrel S, Cannas G, Gauthier A, Fort R, Bertrand Y, Renoux C, Joly P, Boisson C, Hot A, Peter-Derex L, Pialoux V, PetitJean T, Connes P. Nocturnal Hypoxemia Rather Than Obstructive Sleep Apnea Is Associated With Decreased Red Blood Cell Deformability and Enhanced Hemolysis in Patients With Sickle Cell Disease. Front Physiol. 2021 Sep 24;12:743399. doi: 10.3389/fphys.2021.743399. eCollection 2021.

lead_sponsor: Hospices Civils de Lyon

location_facility:
Centre Léon Berard
Hôpital Edouard Herriot
Hôpital de la Croix Rousse


title: 18FluoroDeoxyGlucose-Positron Emission Tomography (PET) in Patients With Melanoma or Non Small Cell Lung Cancer Treated With Immunotherapy

acronym: IMMUNOPET

summary: Study the EFS and OS according to 18FDG PET in patients with melanoma or non small cell lung cancer treated by immunotherapy.

location_facility:
CH de LANDERNEAU
Centre Hospitalier de Morlaix
CHRU de Brest


title: Comparison of the Efficacy of Hybrid Ablative Therapy for Patients With Persistent Atrial Fibrillation Versus Conventional Catheter Ablation

summary:
Atrial fibrillation (AF) is the most common cardiac arrhythmia with a prevalence ranging from 5% over 60 years old to 17% after 85 years old. Besides hemodynamical compromises and occurrence of heart failure, stroke remains the most feared complication related to AF with a risk increased by 5-fold.

Catheter ablation with the aim of pulmonary veins isolation (PVI) has evolved as a standardized treatment option in paroxysmal AF (PAF), supported by the current guidelines. However, due to advanced electrical and structural remodeling, catheter ablation for persistent AF is rather disappointing with a limited success rate, at least after a single procedure. Due to these shortcomings, minimally invasive thoracoscopic surgical techniques have gained attention with good results in persistent AF patients. Comparison between thoracoscopic surgical ablation and catheter ablation have shown that surgical ablation was associated with higher success rates, less redo procedures but also with higher complication rates. The main issue with surgical ablation is the difficulty to check the ablation lines and pulmonary vein isolation, which are the cornerstones for achieving good long-term results.

Hybrid therapy, combining both epicardial surgical and endocardial catheter ablation is expected to be the most effective technique. It would avoid incomplete lesions or incomplete pulmonary vein isolation, and would provide complete lesion set. Hybrid therapy of AF has been compared with mini-invasive surgical ablation of AF, showing a significant higher rate of sinus rhythm achievement in the hybrid therapy group. However, no comparative clinical trials data are currently available in the setting of persistent AF comparing hybrid ablation and conventional catheter ablation.

location_facility:
Cardiology-rytmology service
Cardiology-rytmology
CHU Toulouse, Hôpital Rangueil

intervention_type: Procedure


title: FURosemide Stress Test to Predict Need of Renal Replacement THERapy in Ischemic Acute Tubular Necrosis in ICU

acronym: FURTHER

summary: Ischemic acute tubular necrosis (ATN) is one of the main cause of acute kidney injury (AKI) in intensive care units (ICU). Sepsis and cardio-pulmonary bypass (CPB) are major providers. There is no validated tool to predict the evolution of AKI is ICU. Furosemide Stress Test (FST) may predict evolution of ATN-related AKI outside ICU in terms of progressive AKI, need for renal replacement therapy (RRT) or inpatient mortality with improved performance comparing to biomarkers. FST has not been validated in a prospective cohort in ICU in the settings of ischemic ATN. FURTHER aim to determine whether FST would be a useful tool to identify patients with slight to moderate AKI (KDIGO stage 1 and 2) who will evolve towards need for RRT following AKIKI (The Artificial Kidney Initiation in Kidney Injury ) delayed initiation criteria.

location_facility:
Hopital Bichat
CH Cote Basque
Hopital Saint Louis


title: Changes in Cerebral Circulation and Oxygenation During Hemodynamic Resuscitation in Critically Ill Children Without Head Trauma

acronym: CIRCU-REAPED

summary:
The principal purpose of this study is to describe the changes in cerebral circulation (assessed by transcranial ultrasound) and oxygenation (assessed by Near InfraRed spectroscopy, NIRS) during resuscitation for hemodynamic failure (arterial hypotension or shock) in critically ill children treated with vasoactive or inotropic drugs.

The secondary objectives are :

i) to evaluate the association between an alteration of cerebral circulation and/or oxygenation and an alteration in macro-circulatory parameters (Mean Arterial Blood Pressure and cardiac output) or a bad outcome, ii) to study if cerebral autoregulation is impaired

ReferenceCitation: Vedrenne-Cloquet M, Chareyre J, Léger PL, Genuini M, Renolleau S, Oualha M. Low Dosing Norepinephrine Effects on Cerebral Oxygenation and Perfusion During Pediatric Shock. Front Pediatr. 2022 Jul 6;10:898444. doi: 10.3389/fped.2022.898444. eCollection 2022.

location_facility:
Hôpital Trousseau
Hôpital Robert Debré
Hôpital Necker


title: Stereotactic Radiotherapy for Cerebral Metastases With Recent Hemorrhagic Signal: Phase 2 Study in 2 Steps

acronym: STEREO-HBM

summary: This prospective 2-stage, non-randomized Phase 2 trial evaluates the safety and efficacy of FSRT for the management of hemorrhagic brain metastases

ReferenceCitation: Lesueur P, Kao W, Leconte A, Geffrelot J, Lequesne J, Lacroix J, Brachet PE, Hrab I, Royer P, Clarisse B, Stefan D. Stereotactic radiotherapy on brain metastases with recent hemorrhagic signal: STEREO-HBM, a two-step phase 2 trial. BMC Cancer. 2020 Feb 22;20(1):147. doi: 10.1186/s12885-020-6569-1.

lead_sponsor: Centre Francois Baclesse

location_facility:
Centre François Baclesse
Centre de la Baie
Institut de Cancérologie de Lorraine

intervention_type: Radiation


title: Dépistage Des métastases cérébrales Par IRM Chez Les Patients Avec un adénocarcinome Colorectal métastatique

summary: The aim of this study is to prospectively determine the incidence of brain metastases in metastatic colorectal cancer patients using systematic annual screening by MRI.

primary_purpose: Screening

lead_sponsor: Poitiers University Hospital

location_facility:
C.H.U. d'Amiens
C.H.U. de Poitiers
C.H.U. de Tours


title: Outpatient Management of Primary Spontaneous Pneumothorax: Pigtail Catheter With Unidirectional Valve vs. Exsufflation, Randomized Prospective Study

acronym: PNEUM-AMBU

summary: The management of spontaneous large pneumothorax is not consensual. The current management involves the establishment of a Fuhrman catheter and an outpatient monitoring in pneumology consultation. Another alternative is widespread: simple exsufflation. However, no study has looked at the direct prospective comparison of these 2 treatments.

lead_sponsor: Rennes University Hospital

location_facility:
CH Saint-Malo
CH Lorient
CHU Rennes


title: Pilot Feasibility Study for Cystic Fibrosis Sputum Validation for the Molecular Diagnosis of Respiratory Viral Infections

acronym: EXPIRE

summary: The aim of this pilot study is to demonstrate the feasibility of viral biomolecular diagnosis in sputum compared to nasopharyngeal swab in cystic fibrosis acute respiratory infection.

location_facility:
Hôpital Foch
Centre de Perharidy
CHU d'Angers


primary_purpose: Supportive Care

acronym: ANTICIPUSC

title: Multicenter, Randomized, Open Study, Assessing Prophylactic Noninvasive Ventilation in Intensive Care Unit vs Postoperative Standard Care for Patients With High Risk of Postoperative Pulmonary Complication With Preoperative ARISCAT Score

lead_sponsor: Institut Cancerologie de l'Ouest

ReferenceCitation: Abrard S, Rineau E, Seegers V, Lebrec N, Sargentini C, Jeanneteau A, Longeau E, Caron S, Callahan JC, Chudeau N, Beloncle F, Lasocki S, Dupoiron D. Postoperative prophylactic intermittent noninvasive ventilation versus usual postoperative care for patients at high risk of pulmonary complications: a multicentre randomised trial. Br J Anaesth. 2022 Jan 5. pii: S0007-0912(21)00765-0. doi: 10.1016/j.bja.2021.11.033. [Epub ahead of print]

location_facility:
Chu D'Angers
Ch Du Mans
Institut de Cancerologie de L'Ouest

summary:
Postoperative pulmonary complications are one of the most common complications after surgery.

Noninvasive ventilation has been proposed post-operatively to prevent postoperative pulmonary complications.

Prophylactic noninvasive ventilation performed systematically in a non-specific population is without interest.

The difficulty for the practitioner is to target patients at higher risk of developing a postoperative pulmonary complications in order to guiding them to a post-operative specialized care pathway.

The use of the ARISCAT score, validated on a large European prospective cohort, makes it possible to evaluate, preoperatively, the risk of occurrence of postoperative pulmonary complication in the patient.

The hypothesis of the present research is that early postoperative preventive treatment with noninvasive ventilation, in patients at risk of postoperative pulmonary complications according to the preoperative evaluation according to the ARISCAT score, could have an interest in reducing these complications with a superior efficiency over standard techniques.


title: Effects of Menthol on Dyspnoea Induced by Exercise in COPD Patients

acronym: MEDiC

summary: Chronic obstructive pulmonary disease (COPD) is characterised by non-reversible bronchial obstruction associated with systemic disorders and comorbid factors. Dyspnoea is a common symptom among patients with Chronic Obstructive pulmonary Disease (COPD). Dyspnea is the primary symptom limiting exercise and daily activities in these patients. It has been reported that breathing cold air could decrease dyspnoea induced by exercise and could improve exercise performance. The aim of this study is to carry out the effect of cooling sensation induced by menthol chewing-gum on dyspnoea and exercise performance among patients with COPD.

ipd_sharing_description: Data type : deidentified participtant data

lead_sponsor: Groupe Hospitalier du Havre

location_facility:
Centre hospitalier des Pays de Morlaix
Groupe Hospitalier du Havre
Resp'Air


title: Validation of a Genetic Signature to Predict the Development of Sarcomas

acronym: PREDISARC

summary:
The aim of the SARI study was to describe biomarkers of predisposition to the development of sarcomas in irradiated territory. This study included 120 patients with sarcoma in irradiated territory and 240 patients who had been treated with radiotherapy for more than 5 years and had not developed sarcoma.

Following the sequencing of the exomes of all these patients, the SARI study made it possible to highlight a genetic signature from 11 genes, predictive of the appearance of a sarcoma after a first radiotherapy. This signature is the subject of a patent (BFF 170286 / VF, filed on June 22, 2017). A final validation step with samples that have not been used to optimize this signature is now required. Moreover, it is now necessary to validate if this signature is specific to the predisposition to the development of radiation-induced sarcomas only or if this signature is also valid for the predisposition to the development of all sarcomas, even primary ones.

The objective of the PREDISARC study is to evaluate the specificity of this genetic signature (11 genes) with the appearance of sarcomas in irradiated territory compared to a population without sarcoma that has been treated with radiotherapy.

location_facility:
Institu Bergonie
Centre Georges François Leclerc
Institut Gustave Roussy


title: Cisplatin or ImmunoTHerapy in Association With Definitive Radiotherapy in HPV-related oropharyngEal Squamous Cell Carcinoma: a Randomized Phase II Trial.

acronym: CITHARE

summary:
This study is a phase II, multicenter, open-label study that has been designed to evaluate the efficacy and the safety of definitive Radiotherapy (RT) (70 Gy) delivered in combination with the anti-PD-L1 Durvalumab immunotherapy in patients with Human Papilloma Virus (HPV)-related oropharyngeal squamous cell carcinoma.

In this phase II trial, patients will be assigned in one of the two treatment arms:

Arm A (standard arm): Chemoradiotherapy arm
Arm B (Experimental arm): Immunotherapy + Radiotherapy arm

Total duration of treatment will be 6 months (at maximum in the experimental arm).

Patients will be followed for a maximum of 2 years following the date of randomization.

lead_sponsor: Institut Claudius Regaud

location_facility: Institut Universitaire du Cancer Toulouse (IUCT-O)


title: Immunophenotyping of Blood Cells in the Diagnosis Work-up of Myelodysplastic Syndromes

acronym: MODIFY

summary: Myelodysplastic syndromes (MDS) are a heterogeneous group of hematological malignancies characterized by cytopenia(s), dysplasia in one or more major myeloid cell lines and progression to acute leukemia. Morphological analysis of peripheral blood (PB) and bone marrow (BM) remains the cornerstone of the diagnosis. Preliminary studies identified Flow Cytometry (FC) markers on red cells, platelets and circulating leukocytes that are expressed differently in MDS and in controls. However, these markers have been evaluated separately. The investigators propose to test in a large cohort of patients these markers, and to combine the most relevant ones in order to define a PB FC-based diagnosis score that would discriminate between MDS and non-clonal hematopoiesis and would avoid useless bone marrow samples in elderly

lead_sponsor: Centre Hospitalier Universitaire, Amiens

location_facility:
CHU Rouen
CHU Amiens-Picardie
CHRU Lille


title: Pemetrexed in Maintenance in Patients With Impaired Renal Function: Randomized Phase 4 Multicenter Study Comparing 2 Dose Calculation Strategies (PKAPIR)

acronym: PKAPIR

summary:
Pemetrexed is used in the treatment of non-small cell lung cancer (NSCLC). Its elimination is mainly renal and its nephrotoxicity requires an interruption of treatment when the CrCLCG falls below 45 mL / min. Patients with NSCLC frequently have impaired renal function by other cytotoxic drugs.

The dose adjustment of pemetrexed is performed as a function of body surface area (SC) without any pharmacokinetic rational. The challenge is to treat patients with renal insufficiency (RR) with a safe dose, based on CRCL, providing equivalent biological exposure to patients with preserved renal function.

location_facility: Centre Universitaire Hospitalier de Dijon


title: Olfactory Training and Emotional State

acronym: ENOLFEA

summary:
During the past three decades, researchers have paid particular attention to the study of olfactory disorders in depression. Recent studies have shown that depression is characterized by a change in olfactory and emotional perception resulting in a decrease of the perception of positive stimuli (odors and facial expressions) and an increase in perception of negative stimuli (odors). Moreover, it has also been shown in healthy subjects that the presence of minor depressive symptoms leads to a decreasing of olfactory sensitivity. However, odor discrimination was not impaired in these subjects. This observation suggest the presence of a change in "targeted" olfactory perception in people with depressive symptoms without reporting major depression. In addition, studies in subjects with olfactory disorders (following respiratory tract infections or following Parkinson's disease) have shown an improvement in olfactory function after daily training with odors during 12 weeks.

From all these observations, the hypothesis is that an olfactory training could improve the overall olfactory functioning and the emotional perception of the subjects presenting minor depressive symptoms and of the depressed patients.

location_facility: University health service, University ,Tours

location_facility: University Psychiatric Clinic, University hospital,Tours


title: X-linked Hypophosphatemia and Carbohydrate and Lipid Metabolism: a Role for FGF21?

acronym: XLH 21

summary:
Fibroblast Growth Factor 23 and Fibroblast Growth Factor 21 are two endocrine Fibroblast Growth Factors, requiring Klotho as a co-factor to promote their systemic actions. Fibroblast Growth Factor 21 is involved in the regulation of glucid and lipid metabolism. Fibroblast Growth Factor 21 Knock Out mice display obesity and hyperglycemia.

In investigators experience, patients with X-linked hypophosphatemia often present with early-onset over-weight that could be partly explained by decreased physical activity because of bone pains and deformations after puberty; however, patients usually display progressive over-weight earlier in life, when there is no limitation of physical activity yet.

To the knowledge of investigators the association between Fibroblast Growth Factor 23, Fibroblast Growth Factor 21 and Klotho in patients with X-linked hypophosphatemia has never been evaluated. Thus, the main objective of this study is to evaluate the glucid and lipid metabolism in patients with X-linked hypophosphatemia, the main working hypothesis being that the genetic deregulation in the Fibroblast Growth Factor 23 axis in patients with X-linked hypophosphatemia induces modifications of Klotho levels (namely decreased levels) that in turn will deregulate the Fibroblast Growth Factor 21 axis (resistance to Fibroblast Growth Factor 21 because of decreased Klotho levels).

time_perspective: Cross-Sectional

location_facility: Centre de Référence des Maladies Rénales Rares - Centre de Référence des Maladies Rares du Calcium et du Phosphate - Service de Néphrologie, Rhumatologie et Dermatologie Pédiatriques - Hôpital Femme Mère Enfant

location_facility: Centre de Référence des Maladies Rares du Calcium et du Phosphore, Service d'Endocrinologie Pédiatrique - Hôpital du Kremlin Bicêtre

location_facility: Endocrinologie, Maladies Osseuses, Gynécologie, Génétique, Hôpital des Enfants, CHU de Toulouse


title: Healthcare Renunciation in Patient With Respiratory Chronic Disease and Treatment Compliance

acronym: OBSERVE

summary:
Health care renunciation is a factor that can alter patients' health status and increase the costs of its support.

To date, there is no national data on the renunciation of care. This study will initially characterize the different forms of health care renunciation in patients with chronic respiratory diseases, treated with continuous positive airway pressure (CPAP) or non-invasive ventilation (NIV) , and analyze it impact on treatment compliance and health processes.

The follow-up of these patients during 5 years will define renunciation trajectories (transition from the state of "renouncing" to "non-renouncing" and vice versa) and their impact on treatment compliance.

The investigators hypothesize that a patient becoming renounced on a given treatment also decreases his treatment compliance (CPAP or NIV ).

The impact of the renunciation trajectory on the patient's follow-up in terms of hospitalizations and deaths will also be studied.

ReferenceCitation: Senaratna CV, Perret JL, Lodge CJ, Lowe AJ, Campbell BE, Matheson MC, Hamilton GS, Dharmage SC. Prevalence of obstructive sleep apnea in the general population: A systematic review. Sleep Med Rev. 2017 Aug;34:70-81. doi: 10.1016/j.smrv.2016.07.002. Epub 2016 Jul 18. Review.

ReferenceCitation: Deniz S, Şengül A, Aydemir Y, Çeldir Emre J, Özhan MH. Clinical factors and comorbidities affecting the cost of hospital-treated COPD. Int J Chron Obstruct Pulmon Dis. 2016 Dec 2;11:3023-3030. eCollection 2016.

ReferenceCitation: Borel JC, Pepin JL, Pison C, Vesin A, Gonzalez-Bermejo J, Court-Fortune I, Timsit JF. Long-term adherence with non-invasive ventilation improves prognosis in obese COPD patients. Respirology. 2014 Aug;19(6):857-65. doi: 10.1111/resp.12327. Epub 2014 Jun 9.

ReferenceCitation: Daabek N, Tamisier R, Foote A, Revil H, Joyeux-Jaure M, Pépin JL, Bailly S, Borel JC. Impact of Healthcare Non-Take-Up on Adherence to Long-Term Positive Airway Pressure Therapy. Front Public Health. 2021 Aug 17;9:713313. doi: 10.3389/fpubh.2021.713313. eCollection 2021.

lead_sponsor: University Hospital, Grenoble

location_facility:
Centre Santé Sommeil
Bruno LEPAULE
EFCR HP2 Laboratory


title: IBD-Disk Validation Study for Disability Assessment Functional of Patients With Inflammatory Diseases Intestinal Chronic

acronym: VALIDate

summary: Inflammatory Bowel Diseases (IBD) often affect psychological, family, social and professional dimensions of patients' life, leading to disability which is essential to quantify as part of Patient-Reported Outcomes (PROs) newly included in the therapeutic targets to reach in IBD patients. Up to now, the IBD-Disability Index (IBD-DI) was the only validated tool to assess functional status, but it is not appropriate for use in clinical practice. The IBD Disk was then developed, a shortened and self-administered tool, adapted from the IBD-DI, in order to give immediate representation of patient-reported disability. However, the IBD Disk has not been validated yet in clinical practice. The aims of the VALIDate study is to validate this tool in a large population of French IBD patients and to compare it to the already validated IBD-DI.

ReferenceCitation: Le Berre C, Bourreille A, Flamant M, Bouguen G, Siproudhis L, Dewitte M, Dib N, Cesbron-Metivier E, Goronflot T, Hanf M, Gourraud PA, Kerdreux E, Poinas A, Trang-Poisson C. Protocol of a multicentric prospective cohort study for the VALIDation of the IBD-disk instrument for assessing disability in inflammatory bowel diseases: the VALIDate study. BMC Gastroenterol. 2020 Apr 16;20(1):110. doi: 10.1186/s12876-020-01246-7.

lead_sponsor: Nantes University Hospital

location_facility:
Angers University Hospital
Rennes University Hospital
Nantes University Hospital


type: Registry Identifier

title: Qi Gong as a Method of Craving Reduction in Severe Addict Patients

acronym: QICA

summary:
Craving arises in response to an affective tone that is associated with perceptual representations of a sensory object, rather than directly in response to the object.

The investigators presume that qi gong functions to decouple pleasant and unpleasant experience from habitual reactions by removing the affective bias that fuels such emotional reactivity. Qi gong training may specifically target the associated learning process with an emphasis on the critical link between affect and craving in an addictive loop.

location_facility:
Hôpital Saint ELOI
Groupe Hospitalier Pitié Salpêtrière
Hôpital L'ARCHET


title: National, Multicentre, Pilot Study, to Evaluate Safety and Performance of the V-STRUT© Transpedicular Vertebral System Indicated for Vertebral Compression Fracture Treatment

summary: The purpose of this pilot study is to evaluate the safety and performance of the V-STRUT© Transpedicular Vertebral System for the treatment of vertebral compression fractures of the thoracic or lumbar spine.

ReferenceCitation: Cornelis FH, Tselikas L, Carteret T, Lapuyade B, De Baere T, Le Huec JC, Deschamps F. Percutaneous internal fixation with Y-STRUT® device to prevent both osteoporotic and pathological hip fractures: a prospective pilot study. J Orthop Surg Res. 2017 Feb 9;12(1):27. doi: 10.1186/s13018-017-0514-2.

ReferenceCitation: Cornelis FH, Deschamps F. Augmented osteoplasty for proximal femur consolidation in cancer patients: Biomechanical considerations and techniques. Diagn Interv Imaging. 2017 Sep;98(9):645-650. doi: 10.1016/j.diii.2017.06.014. Epub 2017 Jul 27. Review.

ReferenceCitation: Cornelis FH, Tselikas L, Carteret T, Lapuyade B, De Baere T, Cabane V, Rodrigues L, Maas C, Deschamps F. A Novel Implant for the Prophylactic Treatment of Impending Pathological Fractures of the Proximal Femur: Results from a Prospective, First-in-Man Study. Cardiovasc Intervent Radiol. 2017 Jul;40(7):1070-1076. doi: 10.1007/s00270-017-1613-5. Epub 2017 Feb 23.

ReferenceCitation: Szpalski M,Le Huec JC, Jayankura M, Reynders P, Maas C(2017) Contralateral Prophylactic Reinforcement in Case of First Low-Energy Hip Fracture: First-in-Man Clinical Data of a New Percutaneous Internal Fixation Device. J Osteopor Phys Act 5:202. doi:10.4172/2329-9509.100020

ReferenceCitation: Upasani VV, Robertson C, Lee D, Tomlinson T, Mahar AT. Biomechanical comparison of kyphoplasty versus a titanium mesh implant with cement for stabilization of vertebral compression fractures. Spine (Phila Pa 1976). 2010 Sep 1;35(19):1783-8. doi: 10.1097/BRS.0b013e3181b7cc5d.

ReferenceCitation: Ghofrani H, Nunn T, Robertson C, Mahar A, Lee Y, Garfin S. An evaluation of fracture stabilization comparing kyphoplasty and titanium mesh repair techniques for vertebral compression fractures: is bone cement necessary? Spine (Phila Pa 1976). 2010 Jul 15;35(16):E768-73. doi: 10.1097/BRS.0b013e3181d260bf.

ReferenceCitation: Belkoff SM, Mathis JM, Jasper LE. Ex vivo biomechanical comparison of hydroxyapatite and polymethylmethacrylate cements for use with vertebroplasty. AJNR Am J Neuroradiol. 2002 Nov-Dec;23(10):1647-51.

ReferenceCitation: Rodrigues DC, Ordway NR, Ma CR, Fayyazi AH, Hasenwinkel JM. An ex vivo exothermal and mechanical evaluation of two-solution bone cements in vertebroplasty. Spine J. 2011 May;11(5):432-9. doi: 10.1016/j.spinee.2011.02.012. Epub 2011 Apr 11.

ReferenceCitation: Tutton SM, Pflugmacher R, Davidian M, Beall DP, Facchini FR, Garfin SR. KAST Study: The Kiva System As a Vertebral Augmentation Treatment-A Safety and Effectiveness Trial: A Randomized, Noninferiority Trial Comparing the Kiva System With Balloon Kyphoplasty in Treatment of Osteoporotic Vertebral Compression Fractures. Spine (Phila Pa 1976). 2015 Jun 15;40(12):865-75. doi: 10.1097/BRS.0000000000000906.

ReferenceCitation: Dohm M, Black CM, Dacre A, Tillman JB, Fueredi G; KAVIAR investigators. A randomized trial comparing balloon kyphoplasty and vertebroplasty for vertebral compression fractures due to osteoporosis. AJNR Am J Neuroradiol. 2014 Dec;35(12):2227-36. doi: 10.3174/ajnr.A4127. Epub 2014 Oct 9.

ReferenceCitation: Olivarez LM, Dipp JM, Escamilla RF, Bajares G, Perez A, Stubbs HA, Block JE. Vertebral augmentation treatment of painful osteoporotic compression fractures with the Kiva VCF Treatment System. SAS J. 2011 Dec 1;5(4):114-9. doi: 10.1016/j.esas.2011.06.001. eCollection 2011.

ReferenceCitation: Wang CH, Ma JZ, Zhang CC, Nie L. Comparison of high-viscosity cement vertebroplasty and balloon kyphoplasty for the treatment of osteoporotic vertebral compression fractures. Pain Physician. 2015 Mar-Apr;18(2):E187-94.

ReferenceCitation: Li X, Yang H, Tang T, Qian Z, Chen L, Zhang Z. Comparison of kyphoplasty and vertebroplasty for treatment of painful osteoporotic vertebral compression fractures: twelve-month follow-up in a prospective nonrandomized comparative study. J Spinal Disord Tech. 2012 May;25(3):142-9. doi: 10.1097/BSD.0b013e318213c113.

ReferenceCitation: Deschamps F, de Baere T. Cementoplasty of bone metastases. Diagn Interv Imaging. 2012 Sep;93(9):685-689. doi: 10.1016/j.diii.2012.06.009. Epub 2012 Aug 11.

ReferenceCitation: Kobayashi N, Numaguchi Y, Fuwa S, Uemura A, Matsusako M, Okajima Y, Ishiyama M, Takahashi O. Prophylactic vertebroplasty: cement injection into non-fractured vertebral bodies during percutaneous vertebroplasty. Acad Radiol. 2009 Feb;16(2):136-43. doi: 10.1016/j.acra.2008.05.005.

ReferenceCitation: Otten LA, Bornemnn R, Jansen TR, Kabir K, Pennekamp PH, Wirtz DC, Stuwe B, Pflugmacher R. Comparison of balloon kyphoplasty with the new Kiva® VCF system for the treatment of vertebral compression fractures. Pain Physician. 2013 Sep-Oct;16(5):E505-12.

ReferenceCitation: Yang EZ, Xu JG, Huang GZ, Xiao WZ, Liu XK, Zeng BF, Lian XF. Percutaneous Vertebroplasty Versus Conservative Treatment in Aged Patients With Acute Osteoporotic Vertebral Compression Fractures: A Prospective Randomized Controlled Clinical Study. Spine (Phila Pa 1976). 2016 Apr;41(8):653-60. doi: 10.1097/BRS.0000000000001298.

ReferenceCitation: Korovessis P, Vardakastanis K, Repantis T, Vitsas V. Balloon kyphoplasty versus KIVA vertebral augmentation--comparison of 2 techniques for osteoporotic vertebral body fractures: a prospective randomized study. Spine (Phila Pa 1976). 2013 Feb 15;38(4):292-9. doi: 10.1097/BRS.0b013e31826b3aef. Erratum in: Spine (Phila Pa 1976). 2013 Nov 1;38(23):E1506.

ReferenceCitation: Shindle MK, Gardner MJ, Koob J, Bukata S, Cabin JA, Lane JM. Vertebral height restoration in osteoporotic compression fractures: kyphoplasty balloon tamp is superior to postural correction alone. Osteoporos Int. 2006 Dec;17(12):1815-9. Epub 2006 Sep 16.

ReferenceCitation: Liu JT, Li CS, Chang CS, Liao WJ. Long-term follow-up study of osteoporotic vertebral compression fracture treated using balloon kyphoplasty and vertebroplasty. J Neurosurg Spine. 2015 Jul;23(1):94-8. doi: 10.3171/2014.11.SPINE14579. Epub 2015 Apr 17.

ReferenceCitation: Evans AJ, Kip KE, Brinjikji W, Layton KF, Jensen ML, Gaughen JR, Kallmes DF. Randomized controlled trial of vertebroplasty versus kyphoplasty in the treatment of vertebral compression fractures. J Neurointerv Surg. 2016 Jul;8(7):756-63. doi: 10.1136/neurintsurg-2015-011811. Epub 2015 Jun 24.

ReferenceCitation: Chen D, An ZQ, Song S, Tang JF, Qin H. Percutaneous vertebroplasty compared with conservative treatment in patients with chronic painful osteoporotic spinal fractures. J Clin Neurosci. 2014 Mar;21(3):473-7. doi: 10.1016/j.jocn.2013.05.017. Epub 2013 Aug 8.

ReferenceCitation: Comstock BA, Sitlani CM, Jarvik JG, Heagerty PJ, Turner JA, Kallmes DF. Investigational vertebroplasty safety and efficacy trial (INVEST): patient-reported outcomes through 1 year. Radiology. 2013 Oct;269(1):224-31. doi: 10.1148/radiol.13120821. Epub 2013 May 21.

ReferenceCitation: Tan HY, Wang LM, Zhao L, Liu YL, Song RP. A prospective study of percutaneous vertebroplasty for chronic painful osteoporotic vertebral compression fracture. Pain Res Manag. 2015 Jan-Feb;20(1):e8-e11. Epub 2014 Jun 19.

ReferenceCitation: Korovessis P, Repantis T, Miller LE, Block JE. Initial clinical experience with a novel vertebral augmentation system for treatment of symptomatic vertebral compression fractures: a case series of 26 consecutive patients. BMC Musculoskelet Disord. 2011 Sep 22;12:206. doi: 10.1186/1471-2474-12-206.

ReferenceCitation: Yi X, Lu H, Tian F, Wang Y, Li C, Liu H, Liu X, Li H. Recompression in new levels after percutaneous vertebroplasty and kyphoplasty compared with conservative treatment. Arch Orthop Trauma Surg. 2014 Jan;134(1):21-30. doi: 10.1007/s00402-013-1886-3. Epub 2013 Nov 28.

ReferenceCitation: Vogl TJ, Pflugmacher R, Hierholzer J, Stender G, Gounis M, Wakhloo A, Fiebig C, Hammerstingl R. Cement directed kyphoplasty reduces cement leakage as compared with vertebroplasty: results of a controlled, randomized trial. Spine (Phila Pa 1976). 2013 Sep 15;38(20):1730-6. doi: 10.1097/BRS.0b013e3182a14d15.

ipd_sharing_description:
The data analysis of the investigation will carry out a final report that will be sent to the CPP and ANSM.

According to the law N°2002-303 dated March 4, 2002, the patients involved in the study will be informed on demand on the global data analysis.

Regarding publication, if the data analysis provides important and interesting information on the device and its associated procedure for the treatment of vertebral compression fracture which aims to complete the state of the art, it may be decided to publish the corresponding data. In this case, the IPD that will be shared will consists of all IPD that underlie results in this publication.

lead_sponsor: Hyprevention

location_facility:
Polyclinique Bordeaux Nord Aquitaine
Institut Gustave Roussy
APHP - Hôpital Tenon


title: Creation of a Tool to Assess Quality of Life in Patient With Auto-inflammatory Diseases

acronym: MAI-PATIENT

summary: This qualitative interview-based study aim to build a tool to assess quality of life in patients (adults or children) suffering from 6 autoinflammatory diseases (FMF, TRAPS, CAPS, MKD, Still and PFAPA).

location_facility:
Dr Maryam PIRAM
TENON
CH André Mignot


title: Analysis of EPA® (a Food Intake Assessment Tool) as a Screening Test for Malnutrition in General Medicine

acronym: GEN-EPA

summary: The main objective is to evaluate the sensitivity of the EPA® for screening for malnutrition in general medicine in adults.

location_facility: Cabinet médical des Docteurs Le Vagueres et Godard,


title: Medico-economic Assessment of a "IsereADOM" Package of Services Versus Conventional Monitoring in the Care of a Population of Frail Elderly People With Loss of Autonomy.

acronym: PARC

summary:
The goal of this study is to evaluate the effectiveness of the IsereADOM service package compared to conventional follow-up on the risk of recurrence of falls at 6 months in frail elderly subjects.

There is a medico-economic goal too, is to conduct a cost-utility analysis of the IsereADOM service bundle compared to conventional 6-month follow-up from the community perspective in the cheat population at risk of re-offending.

primary_purpose: Health Services Research

ReferenceCitation: Gillespie LD, Robertson MC, Gillespie WJ, Sherrington C, Gates S, Clemson LM, Lamb SE. Interventions for preventing falls in older people living in the community. Cochrane Database Syst Rev. 2012 Sep 12;(9):CD007146. doi: 10.1002/14651858.CD007146.pub3. Review.

ReferenceCitation: Moyer VA; U.S. Preventive Services Task Force. Prevention of falls in community-dwelling older adults: U.S. Preventive Services Task Force recommendation statement. Ann Intern Med. 2012 Aug 7;157(3):197-204.

ReferenceCitation: Gates S, Smith LA, Fisher JD, Lamb SE. Systematic review of accuracy of screening instruments for predicting fall risk among independently living older adults. J Rehabil Res Dev. 2008;45(8):1105-16. Review.

ReferenceCitation: Payen JF, Chanques G, Mantz J, Hercule C, Auriant I, Leguillou JL, Binhas M, Genty C, Rolland C, Bosson JL. Current practices in sedation and analgesia for mechanically ventilated critically ill patients: a prospective multicenter patient-based study. Anesthesiology. 2007 Apr;106(4):687-95; quiz 891-2.

ReferenceCitation: Manca A, Hawkins N, Sculpher MJ. Estimating mean QALYs in trial-based cost-effectiveness analysis: the importance of controlling for baseline utility. Health Econ. 2005 May;14(5):487-96.

location_facility:
Centre Hospitalier Pierre Oudot
Centre Hospitalier de Voiron
CHU Grenoble-Alpes


title: Short-, Medium- and Long-term (up to 3 Years) Evaluation After Reconstruction of the Anterior Cruciate Ligament of the Knee Using the Bioresorbable Interference Screw (SMS): Resorbability, Per- and Post-operative Complications and Articular Functional Recovery.

acronym: BIORELICA

summary: The investigators will evaluate the benefit of a new bioresorbable screw for repair of anterior cruciate ligament over 3 years.

lead_sponsor: Centre Hospitalier Universitaire de Nīmes

location_facility:
Polyclinique Urbain V
CHU Nimes
Centre Régina


title: Validation of the French Version of the Three Scales for Assessing the Fear of Type 1 Hypoglycemia (HFS-C, HFS-PYC and HFS-P) in Children, Adolescents and Their Parents by a Monocentric Transverse Psychometric Study

acronym: FHS

summary:
Type 1 diabetes usually appears brutally in children or young adults. While many factors of poor glycemic balance have been identified in the literature (age, socio-cultural and socio-economic level, family structure, adherence etc.), it turns out that hypoglycemia is the most common acute complications. It would be an important physiological and psychological barrier for the patient and his parents to manage this diabetes, the latter seeking to keep the blood glucose levels above the objectives in order to avoid the occurrence of a hypoglycemia, especially nocturnal.

If there is a questionnaire currently validated as a tool to measure the fear of hypoglycemia (HFS, Hypoglycemia Fear Survey is available in three versions: L'HFS-Child (HFS-C) for children over 6 years old, HFS-Parents of Young children ( HFS-PYC) for parents of young children (under 8 years of age) and HFS-Parents (HFS-P)) for parents of children over 8 years of age, on the other hand, there are no French and no French studies have evaluated the prevalence and impact of the fear of hypoglycemia in French patients with type 1 diabetes.

It is therefore essential to use a reliable and valid tool to identify patients affected by the fear of hypoglycemia, which can be an obstacle to improve glycemic control and to an optimum quality of life. Having a tool in French and validated on the scientific level would allow to propose adapted therapeutic treatments (psychological follow-up, individual or collective sessions of therapeutic education, material assistance (sensor of blood glucose, pump with insulin stop...) In order to both improve metabolic balance while increasing the quality of life of patients by lowering secondary anxiety to hypoglycemia

lead_sponsor: University Hospital, Brest

location_facility:
Hôpital Universitaire Robert-Debré
Centre Hospitalier de Bretagne Sud
CHRU de Brest


title: Semantic and Syntactic Computerized Analysis of Free Speech

acronym: ASESID

summary: Subtle speech disorganization could be predictive of a transition to schizophrenia of ultra-high-risk patients. The aim of our longitudinal multicenter cohort study is to identify specific linguistic markers of the psychotic transition to validate a french predictive model of this transition using computerized speech analysis techniques

location_facility:
CH de SAINT ANNE
Meunier Sophie
CHRU de Brest


title: Pharmacologic Interaction Between Ifosfamide and Aprepitant in Treated Patients With Soft Tissue Sarcoma

acronym: IPIAP-STM

summary:
This trial is a multicentric study aiming to assess the evolution of the serum ifosfamide concentrations and its serum metabolites in patients treated for an Soft Tissue Sarcoma and co-exposed to Aprepitant.

The study will be conducted on a population of patients treated with Doxorubicin and Ifosfamide. The Aprepitant can be prescribed to patients from cycle 2, according to the current recommendations. Doxorubicin, Ifosfamide and Aprepitant will be administered in the context of routine care. The follow-up during the treatment period and the clinical, biological and radiological assessments will be performed according to the standard of each centre.

Patients will be followed during the two first cycles of treatment. For the pharmacokinetic study, blood samples will be collected at different time points during the 2 treatment cycles.

location_facility: Institut Universitaire Du Cancer de Toulouse - Oncopole

location_facility: Institut Regional Du Cancer de Montpellier (Icm)


title: Effet de la tDCS Sur l'impulsivité Chez Les Personnes Souffrant d'un Trouble Borderline : TIMBER

acronym: TIMBER

summary: The study aims to evaluate the impact of transcranial direct current stimulation (tDCS) on impulsiveness of adults suffering from Borderline Personality Disorder. Short- and long-term effects are assessed by electroencephalography (EEG) records, experimental tasks and self-rated scales.

ReferenceCitation: Storebø OJ, Stoffers-Winterling JM, Völlm BA, Kongerslev MT, Mattivi JT, Jørgensen MS, Faltinsen E, Todorovac A, Sales CP, Callesen HE, Lieb K, Simonsen E. Psychological therapies for people with borderline personality disorder. Cochrane Database Syst Rev. 2020 May 4;5:CD012955. doi: 10.1002/14651858.CD012955.pub2.

ReferenceCitation: Teti Mayer J, Nicolier M, Gabriel D, Masse C, Giustiniani J, Compagne C, Vandel P, Pazart L, Haffen E, Bennabi D. Efficacy of transcranial direct current stimulation in reducing impulsivity in borderline personality disorder (TIMBER): study protocol of a randomized controlled clinical trial. Trials. 2019 Jun 10;20(1):347. doi: 10.1186/s13063-019-3427-z.

lead_sponsor: Centre Hospitalier Universitaire de Besancon

location_facility: Centre Hospitalier Spécialisé de Rouffach

location_facility: Pôle Hospitalo-Universitaire de Psychiatrie du Grand Nancy