title: Perfusion Analysis of the Foot in Patients With Critical Limb Ischemia Before and After Revascularization and Predictive Value on Amputation-free Survival

acronym: DELTA-PERF

summary: This study aims at evaluating the correlation between foot perfusion on angiographies performed before and after revascularization and limb salvage in patients with critical limb ischemia.

ReferenceCitation: Brownrigg JR, Apelqvist J, Bakker K, Schaper NC, Hinchliffe RJ. Evidence-based management of PAD & the diabetic foot. Eur J Vasc Endovasc Surg. 2013 Jun;45(6):673-81. doi: 10.1016/j.ejvs.2013.02.014. Epub 2013 Mar 27. Review.

ReferenceCitation: Wang Z, Hasan R, Firwana B, Elraiyah T, Tsapas A, Prokop L, Mills JL Sr, Murad MH. A systematic review and meta-analysis of tests to predict wound healing in diabetic foot. J Vasc Surg. 2016 Feb;63(2 Suppl):29S-36S.e1-2. doi: 10.1016/j.jvs.2015.10.004. Review.

ReferenceCitation: Wickström JE, Laivuori M, Aro E, Sund RT, Hautero O, Venermo M, Jalkanen J, Hakovirta H. Toe Pressure and Toe Brachial Index are Predictive of Cardiovascular Mortality, Overall Mortality, and Amputation Free Survival in Patients with Peripheral Artery Disease. Eur J Vasc Endovasc Surg. 2017 May;53(5):696-703. doi: 10.1016/j.ejvs.2017.02.012. Epub 2017 Mar 11.

ReferenceCitation: Brownrigg JR, Hinchliffe RJ, Apelqvist J, Boyko EJ, Fitridge R, Mills JL, Reekers J, Shearman CP, Zierler RE, Schaper NC; International Working Group on the Diabetic Foot. Performance of prognostic markers in the prediction of wound healing or amputation among patients with foot ulcers in diabetes: a systematic review. Diabetes Metab Res Rev. 2016 Jan;32 Suppl 1:128-35. doi: 10.1002/dmrr.2704. Review.

lead_sponsor: Centre Hospitalier de Valenciennes


title: Prevalence of the Hyperventilation Syndrome in Pulmonary Arterial Hypertension

summary: Dyspnea is a major symptom in pulmonary arterial hypertension and people with the same haemodynamic have generally different degree of dyspnea in pulmonary arterial hypertension. The hyperventilation syndrome is a frequent cause of dyspnea in general population and in respiratory diseases like asthma but has never been studied in pulmonary hypertension. The goal of this study is to measure the prevalence of pulmonary hypertension in a population of patients with controlled pulmonary arterial hypertension (PAH).

study_start_date_type: Anticipated

status: Unknown status

study_completion_date_type: Anticipated

study_type: Interventional

primary_purpose: Diagnostic

enrollment_type: Anticipated

ipd_sharing: No

lead_sponsor: Assistance Publique - Hôpitaux de Paris

intervention_type: Diagnostic Test

lead_sponsor_type: academique

status_simplified: Unknown


title: Microbiologic Contamination of Home Non Invasive Ventilators

acronym: MiCONIV

summary:
Home non-invasive ventilators are daily used by patients with chronic respiratory failure. There are frequently used with warming and humidifying systems. These systems need to be cared for and frequently washed by the patient.

The aim of this study is to evaluate if the humidifying system of home ventilators are colonized by microbiological germs.

study_start_date_type: Actual

status: Terminated

study_completion_date_type: Actual

study_type: Observational

time_perspective: Prospective

enrollment_type: Actual

lead_sponsor: University Hospital, Rouen


title: Post-marketing Clinical Follow-up Study With Coroflex® ISAR Neo

summary: The aim of the study is to assess the safety and efficacy of the device to treat coronary de novo and restenotic lesions.

status: Recruiting

lead_sponsor: B. Braun Melsungen AG

intervention_type: Device

lead_sponsor_type: industriel

status_simplified: Ongoing


title: Denosumab Related Osteonecrossi of the Jaw : : an Emergent and Potentially Complex Bone and Joint Infection

summary: The aim of this study is to adescription of mandibular osteomylitis in patients having had a treatment by DENOSUMAB. Indeed, one of the adverse effect ot this molecule is to induce mandibular infection.

status: Completed

time_perspective: Retrospective

ipd_sharing: Undecided

lead_sponsor: Hospices Civils de Lyon

intervention_type: Other

status_simplified: Completed


title: Study of Prevalence and Risk Factors of Hypovitaminosis C in Long Term Care Unit

acronym: Vitamin C

summary: The clinical finding of skin rashes which appear after a vitamin C deficiency in Long Term Care Unit leads us to believe that the institutional diet could predispose to this kind of deficiency. Vitamin C has a key role into the struggle against oxidant stress and is involved into the connective tissue formation of the skin and the vascular endothelium. Vitamin C deficiency affects currently 15 to 25% of the elderly over 65 years old reaching 15% women and 20% men after 65 according to Johnston and Al. It concerns mainly the people in precarious situations (persons without fixed homes, ethyl-smoking persons) and elderly over 65 years. Hypovitaminosis C, defined by plasma level between 5 mg/L and 15 mg/L (28.41 to 85.23 µmol/L), is currently undiagnosed, especially with people with a risk of food deficiency and its prevalence increases with age. The treatment consists of a daily oral supplementation of 1 gram of vitamin C/d for 15 days. A minimum intake of 10 mg/D of vitamin C is required to prevent scurvy and maintain a total pool of 350 mg. A diet modification by a systematic intake of 2 glasses of fresh orange juice and/or the consumption of raw fruits and vegetables would prevent the appearance of scurvy.

primary_purpose: Prevention

location_facility: Unité de soins Longue Durée, Hôpital Pierre Garraud (Hospices Civils de Lyon)

intervention_type: Procedure


title: Does Exercise Timing Modify Post-exercise Energy Intake in Adolescents With Obesity

summary: The aim of the present study is to compare the effect of an exercise performed 180 or 30 minutes before lunch on the energy intake of adolescents with obesity.

design_allocation: Randomized

primary_purpose: Other

ReferenceType: derived

ReferenceCitation: Fillon A, Mathieu ME, Masurier J, Roche J, Miguet M, Khammassi M, Finlayson G, Beaulieu K, Pereira B, Duclos M, Boirie Y, Thivel D. Effect of exercise-meal timing on energy intake, appetite and food reward in adolescents with obesity: The TIMEX study. Appetite. 2020 Mar 1;146:104506. doi: 10.1016/j.appet.2019.104506. Epub 2019 Oct 31.

lead_sponsor: University Hospital, Clermont-Ferrand


title: Prospective, Monocentric, Open-label, Randomized Study Comparing Intradialytic Plasma Kinetics of Amino Acids After Administration Per os of Renoral® and Intravenous Administration of Amino Acids.

summary: The aim of the study is to compare intradialytic plasma kinetics of amino acids after administration per os of Renoral or intravenous administration of amino acids in patients with end-stage renal disease treated with hemodialysis maintenance.

lead_sponsor: Indigo Therapeutics

intervention_type: Dietary Supplement


type: Other Identifier

title: To Simulate Prismatic Adaptation in Healthy Subject : a Technical Innovation in Favour of Autonomy and Independence in Daily Life Following a Brain Injury

acronym: PRIS'TUEL

summary:
Unilateral neglect is a neuropsychological disorder reflected by a disturbance in the spatial exploration and distribution of directed attention affecting the contralateral part of space and body relatively to the brain lesion. The chronic aspect of this pathology leads to a poor progression following rehabilitation and a decreased independence of patients in daily life. Thus, it is necessary to set up efficient and long lasting therapies for unilateral neglect patients to improve their daily quality of life. Prismatic adaptation is now a classical method which allows patients to improve their neglect through corrective pointing movements in response to a lateral displacement of the visual field. A large and growing body of literature has investigated prismatic adaptation as a very promising rehabilitation method, improving both visuomotor and cognitive features of unilateral neglect. However, its effects are somehow irregular and clinical applications of this method are still limited. The necessity for patients to come to the hospital to take advantage of prismatic adaption sessions draws some limitations about our knowledge concerning 1) the temporal dynamic of prism adaptation effects on a long-term basis and 2) the optimal duration of treatment (most of the time constrained by the hospitalization duration) and its therapeutical effects on a very long-term basis. Moreover, a large number of patients also suffer from motor deficits which reduce the possibility to optimize the prismatic adaptation session.

Thus, the aim of this project is to develop and validate others modalities of prismatic adaptation which can be applied at home and for a longer duration. These modalities should allow the investigator to get insights about the temporal dynamic of prismatic adaptation on the cognitive system. First, the investigator will investigate the effects of a prismatic adaptation modality using virtual reality to reproduce the lateral displacement induced by the prismatic goggles. He will also investigate prismatic adaptation induced by motor imagery, i.e. with mental representations of pointing movements without concomitant motor execution. This project could enhance the fundamental knowledge and enable to design new modalities of therapeutical use of prismatic adaptation (virtual or imaged) so as to allow a home-based treatment and follow-up. Thus, the aim of this project is to demonstrate the implication of similar mechanisms through different modalities (virtual and imaged compared to classical application) and the feasibility of these new modalities of healthy subjects. Thereafter, the aim will be to use knowledge acquired during this project to set up clinical trials to test for the efficiency of these modalities on a long-term basis in a pathological population.

primary_purpose: Basic Science

intervention_type: Behavioral


title: Comprehensive Study of Social Representation of Platelet Transfusion in Patients Followed for Advanced Hematological Malignancies (R-PLQ)

acronym: R-PLQ

summary: Limited data is available for end of life care in hematologic malignancies, moreover with thrombocytopenic patients. Thrombopenia is a frequent complication, specific of bone marrow involvement in those diseases or its treatments. Yet, a few studies was interested in, whereas platelet transfusion is the only treatment indicated. As it represent a scarce, limited resource, the ethical principles are in conflict in this setting and there's a lack of recommendation. The final decision is take by the clinician and his patient, but no study exist in representation of the two parts. We provide a qualitative study to understand what this decision is made of.

ReferenceType: background

ReferenceCitation: McGrath P, Leahy M. Catastrophic bleeds during end-of-life care in haematology: controversies from Australian research. Support Care Cancer. 2009 May;17(5):527-37. doi: 10.1007/s00520-008-0506-1. Epub 2008 Sep 23.

ReferenceCitation: McGrath P, Holewa H. Special considerations for haematology patients in relation to end-of-life care: Australian findings. Eur J Cancer Care (Engl). 2007 Mar;16(2):164-71.

ReferenceCitation: Jeoffrion C, Dupont P, Tripodi D, Roland-Lévy C. [Social representations of illness: Comparison of "expert" knowledge and "naïve" knowledge]. Encephale. 2016 Jun;42(3):226-33. doi: 10.1016/j.encep.2015.12.007. Epub 2016 Jan 12. French.

ipd_sharing_description: interview will be registered then transcribe on professional computer ans accessible only by the investigator and collaborators.

lead_sponsor: Centre Hospitalier Universitaire de Besancon


title: Evaluation of Early Prognosis Factors of Neurological Evolution After Resuscitated Cardiac Arrest in Adults

acronym: EDGAR

summary: Sudden cardiac arrest (CA) in adults remains a major public health issue in industrialized countries, leading to a mortality rate greater than 90%. The analysis of French data estimates the number of sudden deaths at around 40,000 per year. The incidence rate for non-hospital CAs is 55 per 100,000 every year with an immediate survival rate of 9% and 4.8% at one year.

lead_sponsor: Centre Hospitalier Régional Metz-Thionville


title: Prospective Study of the Feasibility of Stereotactic Navigation in Laparoscopic Surgery for Colorectal Cancer

acronym: PELVINAV

summary: To evaluate the feasibility and precision of stereotaxic navigation in laparoscopic surgery for colorectal cancer.

design_allocation: Non-Randomized

ReferenceCitation: Marley AR, Nan H. Epidemiology of colorectal cancer. Int J Mol Epidemiol Genet. 2016 Sep 30;7(3):105-114. eCollection 2016. Review.

ReferenceCitation: Arnold M, Sierra MS, Laversanne M, Soerjomataram I, Jemal A, Bray F. Global patterns and trends in colorectal cancer incidence and mortality. Gut. 2017 Apr;66(4):683-691. doi: 10.1136/gutjnl-2015-310912. Epub 2016 Jan 27.

ReferenceCitation: Biondi A, Vacante M, Ambrosino I, Cristaldi E, Pietrapertosa G, Basile F. Role of surgery for colorectal cancer in the elderly. World J Gastrointest Surg. 2016 Sep 27;8(9):606-613. Review.

ReferenceCitation: Simmonds PC, Primrose JN, Colquitt JL, Garden OJ, Poston GJ, Rees M. Surgical resection of hepatic metastases from colorectal cancer: a systematic review of published studies. Br J Cancer. 2006 Apr 10;94(7):982-99. Review.

ReferenceCitation: Rullier E, Sebag-Montefiore D. Sphincter saving is the primary objective for local treatment of cancer of the lower rectum. Lancet Oncol. 2006 Sep;7(9):775-7. Review.

ReferenceCitation: Orsini RG, Wiggers T, DeRuiter MC, Quirke P, Beets-Tan RG, van de Velde CJ, Rutten HJ. The modern anatomical surgical approach to localised rectal cancer. EJC Suppl. 2013 Sep;11(2):60-71. doi: 10.1016/j.ejcsup.2013.07.033. Review.

ReferenceCitation: Abu Gazala M, Wexner SD. Re-appraisal and consideration of minimally invasive surgery in colorectal cancer. Gastroenterol Rep (Oxf). 2017 Feb;5(1):1-10. doi: 10.1093/gastro/gox001. Epub 2017 Feb 6. Review.

ReferenceCitation: Bucholz RD. Introduction to Journal of Image Guided Surgery. J Image Guid Surg. 1995;1(1):1-3.

ReferenceCitation: Azagury DE, Dua MM, Barrese JC, Henderson JM, Buchs NC, Ris F, Cloyd JM, Martinie JB, Razzaque S, Nicolau S, Soler L, Marescaux J, Visser BC. Image-guided surgery. Curr Probl Surg. 2015 Dec;52(12):476-520. doi: 10.1067/j.cpsurg.2015.10.001. Epub 2015 Oct 22. Review.

ReferenceCitation: Mezger U, Jendrewski C, Bartels M. Navigation in surgery. Langenbecks Arch Surg. 2013 Apr;398(4):501-14. doi: 10.1007/s00423-013-1059-4. Epub 2013 Feb 22. Review.

ReferenceCitation: Prulière-Escabasse V, Coste A. Image-guided sinus surgery. Eur Ann Otorhinolaryngol Head Neck Dis. 2010 Mar;127(1):33-9. doi: 10.1016/j.anorl.2010.02.009. Epub 2010 Mar 24. Review.

ReferenceCitation: Risholm P, Golby AJ, Wells W 3rd. Multimodal image registration for preoperative planning and image-guided neurosurgical procedures. Neurosurg Clin N Am. 2011 Apr;22(2):197-206, viii. doi: 10.1016/j.nec.2010.12.001. Review.

ReferenceCitation: Fitzpatrick JM. The role of registration in accurate surgical guidance. Proc Inst Mech Eng H. 2010;224(5):607-22.

ReferenceCitation: Wittmann W, Wenger T, Zaminer B, Lueth TC. Automatic correction of registration errors in surgical navigation systems. IEEE Trans Biomed Eng. 2011 Oct;58(10):2922-30. doi: 10.1109/TBME.2011.2163156. Epub 2011 Jul 29.

ReferenceCitation: Gundle KR, White JK, Conrad EU, Ching RP. Accuracy and Precision of a Surgical Navigation System: Effect of Camera and Patient Tracker Position and Number of Active Markers. Open Orthop J. 2017 May 31;11:493-501. doi: 10.2174/1874325001711010493. eCollection 2017.

ReferenceCitation: Baumhauer M, Feuerstein M, Meinzer HP, Rassweiler J. Navigation in endoscopic soft tissue surgery: perspectives and limitations. J Endourol. 2008 Apr;22(4):751-66. doi: 10.1089/end.2007.9827. Review.

ReferenceCitation: Wijsmuller AR, Romagnolo LGC, Agnus V, Giraudeau C, Melani AGF, Dallemagne B, Marescaux J. Advances in stereotactic navigation for pelvic surgery. Surg Endosc. 2018 Jun;32(6):2713-2720. doi: 10.1007/s00464-017-5968-0. Epub 2017 Dec 6.

ReferenceCitation: Atallah S, Nassif G, Larach S. Stereotactic navigation for TAMIS-TME: opening the gateway to frameless, image-guided abdominal and pelvic surgery. Surg Endosc. 2015 Jan;29(1):207-11. doi: 10.1007/s00464-014-3655-y. Epub 2014 Jun 28.

ReferenceCitation: Atallah S, Martin-Perez B, Larach S. Image-guided real-time navigation for transanal total mesorectal excision: a pilot study. Tech Coloproctol. 2015 Nov;19(11):679-84. doi: 10.1007/s10151-015-1329-y. Epub 2015 Jul 9.

ReferenceCitation: Atallah S, Larach SW, Monson JR. Stereotactic navigation for TAMIS-TME. Minim Invasive Ther Allied Technol. 2016 Oct;25(5):271-7. doi: 10.1080/13645706.2016.1201119. Epub 2016 Jun 27.

ReferenceCitation: Bai M, Liu B, Mu H, Liu X, Jiang Y. The comparison of radiation dose between C-arm flat-detector CT (DynaCT) and multi-slice CT (MSCT): a phantom study. Eur J Radiol. 2012 Nov;81(11):3577-80. doi: 10.1016/j.ejrad.2011.09.006. Epub 2011 Oct 2.

ReferenceCitation: Raman SP, Chen Y, Fishman EK. Evolution of imaging in rectal cancer: multimodality imaging with MDCT, MRI, and PET. J Gastrointest Oncol. 2015 Apr;6(2):172-84. doi: 10.3978/j.issn.2078-6891.2014.108. Review.

lead_sponsor: IHU Strasbourg

location_facility: Service de Chirurgie Digestive et Endocrinienne, NHC


title: Does a Diet With the Recommended Amount of Polyunsaturated Fatty Acids, Increase Their Proportion in Maternal Milk? A Prospective Randomized Open Study

acronym: ALLAITEMENT

summary: During pregnancy and lactation, the consumption of PUFA n-3, through the consumption of food products that contain more ALA than conventional products, could impact nutritional and non-nutritional breast milk quality (immune criteria, metabolites, hormones), and also the implantation of the intestinal microbiota of the newborn, which is involved in preservation of short term and long term health of the child.

lead_sponsor: Rennes University Hospital

intervention_type: Biological


title: Evaluation of the Signals électrophysiologiques Measured by Intelligent Textiles

acronym: DATASET

summary:
BioSerenity suggests developing innovative solutions, from intelligent clothes which can be used in a hospital environment or at home. These textiles allow, in particular, to measure the biophysiological signals while letting to the participant the freedom pursue its daily activities.

BioSerenity has already developed two wearable wireless and portable medical devices: cardioskin with textile ECG electrods , and the Neuronaute with textile EEG, EMG electrods.

The aim of the study is to test these sensors to optimize their signal to integrate them in future Bioserenity devices like a somnonaute to help diagnosis of sleep disorders, like uronaute to help diagnosis of urination disorders, like toconaute to help monitoring of pregnancy. Others CE-marked sensors developed by others manufacturers will be tested to choose those that will be integrated in the Bioserenity devices.

lead_sponsor: BioSerenity

location_facility: Institut Du Cerveau Et de La Moelle Epiniere


title: Multimodal Imaging Analysis, SD-OCT and OCT Angiography, Retinal Variations Observed in Dialysis Patients

acronym: OCTADIAL

summary:
Little knowledge exist on the short and long-term ophthalmological effect of the dialysis. Some studies stated a variation of the thickness subfoveal choroidal before and after a session of dialyse as well as variations of the coat of optical fibers measured in OCT.

The Optical Coherence Tomography angiography OCT is a not invasive imaging technique which is now a part of examinations of investigation in imaging of retina. This technique allows to study the retinal macula vascularization without injection of contrast agent and thus allows to deepen the knowledge in medical domains where the exploration was to limited because of the invasive character of the examinations.

The hypothesis of this project is that hemodynamic change during the hemodialysis may lead fine variations of the retinal vascularization in the short-term (the day of the dialysis) but also in the longer term (over 1 year).

lead_sponsor: Centre Hospitalier Intercommunal Creteil


title: Effectiveness of a Condensed Functional Restoration Program for Patients With Chronic Low Back Pain: a Study of 193 Patients

acronym: PRAMH

summary:
The aim was to assess the effectiveness of a condensed functional restoration program (CFRP) for patients with chronic low back pain and professional activity.

Methods: Longitudinal 1 to 3 months study of patients with non-specific chronic low back pain in one tertiary care hospital, participating in a CFRP (complex interprofessional intervention over 4 days). The primary outcome was the Oswestry Disability Index (ODI) (0-100 scale). Secondary outcomes included pain, quality of life (EQ5D), patient acceptable symptom state, presenteeism, absenteeism and psychological distress (Hospital Anxiety and Depression scale). Outcomes were compared using paired sample Student's t-test or Chi2 between baseline and last follow-up. Logistic regression was used to identify factors associated with better response (improvement of ODI higher than 12.8) and included baseline demographic, psychological and physical assessment variables.

lead_sponsor: Pitié-Salpêtrière Hospital


type: EudraCT Number

title: Randomized, Double Blind, Multi Center, Multinational, Placebo Controlled, Single Parallel Escalating Dose Safety and Efficacy Study of ACT017 Used as an Add on Therapy on Top of Standard of Care of Acute Ischemic Stroke

acronym: ACTIMIS

summary: To assess safety of single IV (bolus + infusion) doses of ACT017 in patients with an acute ischemic stroke in addition to best emergency standard of care (including fibrinolysis by rtPA with or without added thrombectomy), with a specific focus on hemorrhage, whether clinically symptomatic (NIHSS score + 4 points or death, without other explanation), or seen (excluding other diagnoses) on 24-hour (hr) CT scan, serious adverse events (SAEs), suspected unexpected serious adverse reactions (SUSARs), and medically important events and other safety items including biological and immunological tolerability.

primary_purpose: Treatment

ReferenceCitation: Voors-Pette C, Lebozec K, Dogterom P, Jullien L, Billiald P, Ferlan P, Renaud L, Favre-Bulle O, Avenard G, Machacek M, Plétan Y, Jandrot-Perrus M. Safety and Tolerability, Pharmacokinetics, and Pharmacodynamics of ACT017, an Antiplatelet GPVI (Glycoprotein VI) Fab. Arterioscler Thromb Vasc Biol. 2019 May;39(5):956-964. doi: 10.1161/ATVBAHA.118.312314.

ReferenceCitation: Renaud L, Lebozec K, Voors-Pette C, Dogterom P, Billiald P, Jandrot Perrus M, Pletan Y, Machacek M. Population Pharmacokinetic/Pharmacodynamic Modeling of Glenzocimab (ACT017) a Glycoprotein VI Inhibitor of Collagen-Induced Platelet Aggregation. J Clin Pharmacol. 2020 Sep;60(9):1198-1208. doi: 10.1002/jcph.1616. Epub 2020 Jun 4.

lead_sponsor: Acticor Biotech

location_facility: Centre Hospitalier Universitaire de Bordeaux,


title: Comparison of the Variations of the Cardiovascular Parameters and the Efficiency of the Osteocentral Anesthesia (Quicksleeper™) and the Locoregional Anesthesia in the Case of Mandibular Pulpitis

acronym: COQ

summary:
The irreversible acute pulpitis is the most common emergency at the hospital during dental consultation. Pulpitis are characterized by intense and spontaneous oro-facial pains. In case of mandibular molar, the emergency treatment consists in realizing a pulpotomy (eviction of cameral pulp) under locoregional anesthesia called inferior alveolar nerve block (IANB). The latter represents a real challenge, since inflammation may decrease its action. To mitigate this deficiency and the drawbacks of the IANB (onset and duration of the anesthesia, bites risk reported with IANB) other anesthesias are proposed. In particular the computerized intraosseous technique anesthesia of which the Quicksleeper™ system is a part. However, according to the observers, a mild to severe tachycardia have been reported.

Very few valid clinical trials exists on the subject, most being realized with systems of intraosseous anesthesia other than Quicksleeper™. Therefore, the aim of this study is first to analyze the variations of the cardiovascular parameters into two groups of anesthesia: locoregional anesthesia and Quicksleeper ™ system; and then, to compare the efficiency, side effects, operating consequences of both techniques. This study should provide better data about potential risk with computerized intraosseous technique such has Quicksleeper ™ system in healthy or cardiovascular risk patient.

lead_sponsor: Nantes University Hospital


type: Registry Identifier

title: Study of the Correlation Between the Effort Test, With the Assessment of Peripheral Oxygen Consumption and Cardiac Output in Patients With Acute Rhabdomyolysis Related to a Hereditary Disease of Metabolism, and the Biochemical Flux on Myoblasts: Evaluate the Effort Test as a Therapeutic Monitoring Tool in Acute Rhabdomyolyses

acronym: EFFORHAB

summary:
The prognosis of rhabdomyolyses related to hereditary diseases of metabolism is poor and treatments are only symptomatic. Rhabdomyolysis outbreaks are frequently precipitated by fever and fasting. They are unpredictable. In spite of the care of patient in an intensive care unit, the occurrence of renal failure and heart rhythm disorders explains a significant acute-phase mortality rate. There is an urgent need to understand the pathophysiological mechanisms of rhabdomyolyses related to hereditary diseases of metabolism, in order to identify specific treatments.

Patients with rhabdomyolyses have few clinical signs outside of access. So there is a methodological difficulty in following a treatment test. There is an urgency to identify follow-up parameters in anticipation of new therapies.

The objective of this study is to validate the hypothesis that effort test and cardiac function parameters are usable in the treatment monitoring for patients with acute rhabdomyolysis linked to a hereditary disease of metabolism and thus propose the effort test as an assessment tool for future clinical trials. In order to do so, the correlation between the results of the effort tests, performed to each patient with rhabdomyolysis related to a hereditary disease of metabolism, with the severity of the disease will be evaluated. This study is original because it opens up innovative prospects for monitoring in the field of hereditary diseases of metabolism, with the identification of new monitoring tools.


title: Cross Over Pilot Study for Evaluation of Pain Reduction in Patients With Chronic Low Back Pain (for More Than 3 Month) Using an Innovative Handheld Device

acronym: ATLAS

summary:
The aim of the study is to evaluate the reduction of pain by wearing the ATLAS Medical Device in standardized daily activities for patients with Chronic Low Back Pain.

This is an intervention al non blinded study with a crossover design comparing pain evaluated with an Analogue Visual Scale with and without the ATLAS device during 5 standardized daily activities.

lead_sponsor: University Hospital, Lille


title: Quantitative Evaluation of the Breast's Morphological Variations During Radiotherapy: Monocentric Feasibility Study MorphoBreast3D

summary: Quantitative evaluation of the breast's morphological variations during radiotherapy consisting in performing three-dimensional surface acquisitions of the breast in order to study its shape and volume. Evaluation of the dosimetric impact of these variations.

lead_sponsor: Centre Paul Strauss


acronym: TTRAP-Bleeding

intervention_type: Drug

title: Study of Thromboelastography During Tranexamic Acid Treatment in Preventing Bleeding in Patients With Haematological Malignancies Presenting Severe Thrombocytopenia (TTRAP-bleeding)

lead_sponsor: Centre Hospitalier Universitaire de Saint Etienne

source: euctr

summary: Patients with hematological malignancies are at increased risk of bleeding, especially during intensive chemotherapy. The aim of this study is to compare by thromboelastography changes during the intensive chemotherapy in patients with hematological malignancies.


title: Immunophenotyping of Blast Cells and Immune Effector Cells in Peripheral Whole Blood and Bone Marrow Samples From AML and MDS Patients

summary: The objective of this study is to evaluate the immune profile of blast cells and immune effector cells in paired peripheral whole blood and bone marrow samples from AML and MDS patients by standardized flow cytometry. A special emphasis will be focused on monitoring expression of CD200 as well as PGP-170 (MDR1) on blasts cells.

lead_sponsor: Assistance Publique Hopitaux De Marseille

location_facility: Assistance Publique - Hopitaux de Marseille


title: DOuble tasK Test On ergometeR - Basic Research on Acceptability and Use

acronym: DOKTORBRAU

summary: The goal of the study is to show the concordance between the dual-task test achieved usually on an electronic treadmill and the dual-task test achieved with a cyclo-ergometer.

lead_sponsor: University Hospital, Angers


title: Characterization of the Fungal Origins in the Autoimmune Polyendocrinopathy of Type 1 Compared With the Autoimmune Polyendocrinopathies of Type 2

summary: Autoimmune polyendocrinopathy candidiasis ectodermal dystrophy (APECED) is an autosomal recessive disease caused by mutations in the autoimmune regulator (AIRE) gene, characterized by the clinical triad of chronic mucocutaneous candidiasis (CMC), hypoparathyroidism, and adrenal insufficiency. CMC can be complicated by systemic candidiasis or oral squamous cell carcinomas (SCCs) and may lead to death. The role of chronic Candida infection in the etiopathogenesis of oral SCC is unclear. Long term use of fluconazole lead to emergence of C. albicans strains with azoles decreased susceptibility. CMC is associated with an impaired Th17 cell response, however, it remains unclear whether decreased serum IL-17 and IL-22 levels are related to a defect in cytokine production or to neutralizing autoantibodies resulting from mutations in the AIRE gene


title: Neural Correlates of Self Body-shape Recognition in Anorexia Nervosa, an fMRI Activation Study

acronym: Explorexie

summary: Body Image distortion is a key diagnostic feature for Anorexia Nervosa. Patients suffering from Anorexia Nervosa tend to perceive themselves as fatter than they are. This bias might be at the origin of a reinforcement of anorectic behavior which might alter medical care. The objective of this study is to identify neural correlates of self-recognition in Anorexia Nervosa. Patients are hypothesized to activate the self-recognition network when seeing images of a fatter body shape than their own.


title: Optimisation of Care and Antiretroviral Therapy in Vulnerable HIV Infected Individuals

acronym: OPTICARE

summary:
Antiretroviral therapy is currently the only way to control HIV disease progression in HIV infected subjects and to prevent transmission. However a sustained virological control through antiretroviral therapy is requested for these objectives. There is currently 8-10% of patients who failed therapy for many reasons other than virological resistance including social unstability, psychiatric disorders, migrant status, drug or alcohol addictions. Because many of these vulnerabilities can be managed and patients helped for following adequately cares and treatments, study team designed the OPTICARE Program to help reduce impact of the patients' vulnerabilities.

The OPTICARE study is designed as a prospective implementation interventional study which aims to improve retention in care among vulnerable HIV infected patients over 48 weeks.

The OPTICARE program is a support program dedicated to patients either lost to follow up or in highly fraility situation that will offer an individualized care management to fill their gaps towards optimized care and control of viral replication. Our aim is, in patients virally failing in relation with poor adherence to care and treatment to test first part whether tracking proactively lost to follow up patients or detecting frail individuals at risk of lost to care is effective and secondly to evaluate the efficacy, the feasibility and the acceptability of an intervention tailored to each individual to get them to treatment success with viral suppression. In our context, a randomized approach would not be seen as ethical or possible in an environment where investigators need to evaluate such intervention as a pilot approach. Investigators therefore enrolled patients in a cohort population study OPTICARE program aim to actively identify vulnerable HIV+ population and promote optimal access to health care to this population using retention in care program in order to enable long term HIV infection control.

The primary objective is to assess the feasability and the effectiveness of the OPTICARE program. The OPTICARE program aims to propose an individualized care to vulnerable HIV infected patients (UNAIDS/Second 90% goal) and to drive them to treatment success (UNAIDS/Third 90% goal) within a one-year period.

primary_purpose: Supportive Care

lead_sponsor: Centre de Recherches et d'Etude sur la Pathologie Tropicale et le Sida


title: Echinocandins Versus Azoles as First-line Therapy for the Treatment of Candidemia in Intensive Care Units

acronym: AntiCandiTreat

summary: Candidemia is the most frequent invasive fungal disease in intensive care units (ICUs). It remains a major health concern, considering its attributable mortality up to 40% in critically ill patients. Successful clinical outcome requires early diagnosis and effective antifungal therapy. Guidelines for the treatment of candidemia were published by the Infectious Diseases Society of America (IDSA) and the European Society of Clinical Microbiology and Infectious Diseases (ESCMID). According to these guidelines, echinocandins are the preferred first-line therapy for candidemia in critically ill patients. Considering the bibliography supporting this statement, the place of triazoles still needs to be defined in candidemia therapeutic arsenal. In this context, we are setting up a retrospective cohort study using Hospital database to compare the efficacy of echinocandins and azoles for the treatment of candidemia in intensive care units.

lead_sponsor: Hospices Civils de Lyon

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


title: Reduce Speed Limits From 90km/h to 80 km/h on French Two-way Roads Without Central Separator: the Number of Traffic Related Fatalities on the Network Concerned "Before and After" the Reduction of Speed Limits.

summary:
On the first July 2018, the French government lowered the maximum authorized speeds on two-way roads without a central separator from 90 km/h to 80 km/h. The network concerned represents approximately 400 000 km of roads outside the built-up area, accounting for 55% of road deaths.

The objective of the measure is to reduce the number of deaths on the roads concerned by encouraging the reduction of the average speed practiced by drivers.

The analysis deals with a comparison of the number of killed persons on the network concerned, before and after the reduction of the speed limits. The "before" period is 2015-2017. The "after" period is from July 2018 to June 2019.

The data used are extracted from the national bodily injury accident file (BAAC). The police fills this file for each road accidents occurring on a road open to public traffic and causing at least one victim (i.e., one user requiring medical care and involving at least one vehicle).

time_perspective: Other

lead_sponsor: Centre d'études et d'expertise sur les risques, l'environnement, la mobilité et l'aménagement


title: Preclinical Validation of New Anti-melanoma Compounds: Study on Patient Melanoma Cells Sensitive and Resistant to BRAF/MEK Inhibitors

acronym: ERMELATHER

summary: This research program is in keeping with the chemistry/biology/clinical interface and gathers 4 teams with complementary expertise in these respective fields. It will allow deciphering the mechanism(s) of action of new Thiazole-Benzenesulfonamide family (TZB) derivatives on metastatic melanoma sensitive and resistant to BRAF and MEK inhibitors. Investigators will use melanoma cell lines and primary cells from patients to validate these compounds in collaboration with clinical team 2 and 4. In conclusion, the investigators expect to establish the proof of concept that this new class of bioactive molecules (first in class) we developed in collaboration with Team 3 have the potential to go to the clinic for the treatment of highly aggressive cancers and particularly metastatic melanoma sensitive and resistant B-Raf and MEK inhibitors. Furthermore, the realization of this project can undoubtedly increase the knowledge of mechanisms and signaling pathways that are involved in resistant to BRAF and MEK inhibitors, and allow the selection of drug candidates capable of restoring the sensitivity of these melanoma cells.

time_perspective: Cross-Sectional

lead_sponsor: Centre Hospitalier Universitaire de Nice


title: Prevalence and Characterization of Persistent Dyspnea After an Hospitalization for a Respiratory Disease

acronym: DyHP

summary: The investigators aim to make an overview of persistent dyspnea at the end of an hospitalization for a respiratory disease using an actual tool, the Multidisciplinary Dyspnea Profile questionnaire.

lead_sponsor: Association pour le Développement et l'Organisation de la Recherche en Pneumologie et sur le Sommeil


title: Real Life Study in Myopic Neovascularization

acronym: VIC

summary:
This is a multi centre, single arm, prospective observational phase 4 study in naive or pretreated patients with myopic neovascularization. The patients will be treated with intravitreal injections of Aflibercept following a real life protocol.

This sudy aims to evaluate the visual acuity during a 36 months period of time.

status: Active, not recruiting

lead_sponsor: Poitiers University Hospital


title: Pharmacokinetics Variability of Posaconazole (PCZ) and Its Glucuronide Metabolite During Induction and Consolidation Treatments in Patients With Acute Myeloid Leukemia (AML): a Covariate Analysis With the Tablets Formulation and Evaluation of the Potential Risk of Hepatotoxicity

acronym: Posa-Pk

summary:
Among its authorized indications, posaconazole (PCZ) is prescribed for prophylaxis in onco-hematology patients at high risk of invasive fungal infections. This azole antifungal has a low bioavailability. The enteric-coated tablets form available since mid-2015 has significantly improved its pharmacokinetic profile compared to the oral suspension form initially used. According to the recommendations of The European Conference on Infections in Leukemia (ECIL-6), the minimum serum concentration desirable for prophylaxis is 0.7 mg/L. This concentration threshold was difficult to achieve in onco-hematology patients treated with oral suspension.

The investigators retrospectively collected and analyzed 201 results of residual PCZ serum concentrations from 91 onco-hematology patients on Noxafil® tablets prophylaxis. The median concentration of PCZ was 1.08 mg/L. In this study, the pharmacokinetics of tablet-PCZ showed significant inter-individual variability. Thus, while 25% of the concentrations remained below the recommended threshold of 0.7 mg/L (25% percentile = 0.69 mg/L), exposure to PCZ was greater than 2.63 mg/L in 10% of cases. This level of exposure, however, did not have obvious hepatic repercussions. Nevertheless, further studies involving larger cohorts are needed to clarify a hypothetical relationship between serum PCZ concentration and the occurrence of hepatic toxicity.

In addition, the investigators found significant intra-individual variability in PCZ exposure (CV = 48.8%), especially in leukemic patients. This variability is probably related to a modification during the treatment of the physio-pathological conditions of the patient likely to impact the pharmacokinetics of PCZ (absorption, distribution, metabolism, etc.) as well as the effect of possible pharmacokinetic drug interactions.

The metabolism of PCZ is mediated primarily by the uridine diphosphate (UDP)-glucuronosyltransferase 1A4 (UGT1A4) pathway. Although hepatic metabolism of PCZ is low compared with other azoles (such as itraconazole or voriconazole), differences in the metabolic capacity of UGT1A4 may alter PCZ exposure. A previous study of the oral suspension form had shown that low concentrations of PCZ were associated with a high ratio of PCZ-glucuronide / PCZ concentrations. Two genetic variants of the gene encoding UGT1A4 are associated with a decrease in the metabolic clearance of glucuronide drugs via UGT1A4. A recent study suggests less exposure to PCZ in the presence of UGT1A4 polymorphism.

The main objective of the investigator's project is to study prospectively in a homogeneous population of patients treated by intensive chemotherapy for acute myeloid leukemia (induction and consolidation) the pharmacokinetics of PCZ administered in its tablet formulation, and in particular:

Clinical and biological tolerance of high concentrations of PCZ
The influence of clinical and demographic covariates on PCZ and PCZ-glucuronide ratio
The influence of genetic variants of UGT1A4 on PCZ metabolism (PCZ-glucuronide / PCZ ratio).

primary_purpose: Health Services Research

location_facility: Centre Hospitalier Lyon Sud, Hematology department


title: Evaluation of Acute Mechanical Revascularization in Large Vessel Occlusion Stroke With Minor Symptoms (NIHSS<6) in Patients Last Seen Well < 24 Hours

acronym: MOSTE

summary:
Stroke represents the fourth leading cause of death in industrialized nations, after heart disease, cancer, and chronic lower respiratory disease. Approximately one-quarter of the patients suffering a stroke die within one year after the initial event and stroke is a leading cause of serious long-term disability. Although mechanical thrombectomy (MT) has become the standard of care for acute ischemic stroke with proximal large vessel occlusion (LVO) in the anterior circulation, the management of patients harboring proximal occlusion but presenting minor-to-mild stroke symptoms, has not yet been determined by these recent randomized clinical trials. However, patients with proximal occlusions may present with a low NIHSS, a proximal intraarterial occlusion being present in up to 28% when considering patients with an NIHSS ≤ 4.

The evidence of benefit from endovascular therapy (EVT) in large vessel occlusion stroke is demonstrated, STAIR IX (Stroke Treatment Academic Industry Roundtable) consensus recommendations were developed that outline priorities for future research in EVT.

lead_sponsor: University Hospital, Montpellier


title: Alexithymia Frequency and Interhemispheric Transfer in Patients With a First Demyelinating Event: Initial Phase of Multiple Sclerosis

acronym: ALEXCIS

summary:
Prevalence of alexithymia in multiple sclerosis (MS) is closed to 50% but is unknown in clinically isolated syndrome (CIS).The present study sought to characterize alexithymia in CIS patients and his link between psycho behavioral and cognitive disturbances.

In this context, the objectives of the present study were to (a ) define the prevalence of alexithymia in CIS patients, (b ) to study this relation between psycho behavioral and cognitive disorders frequently encountered in MS.


title: Prognostic Impact of Delta-haemolysin Production Deficiency in Staphylococcus Aureus on the Prognosis of Infected Implant Treated by DAIR

summary: The aim of this study is to determine if delta-haemolysin production deficiency of Staphylococcus aureus is a marker in favour of chronic infections on implants


title: Phase I / II Study Evaluating the Efficacy and Safety of FOLFIRINOX3 Bevacizumab Treatment in Patients With Colorectal Cancer Who Have Failed With Standard Chemotherapy Protocols (FOLFIRINOX 3)

summary:
In patients in progression after oxaliplatin and irinotecan, the study FOLFIRINOX 3 proposes to evaluate the interest of modifying the standard pattern of administration of the molecule of irinotecan in order to make it more efficient. In combination with other chemotherapy drugs (5-fluorouracil, oxaliplatin, folinic acid and bevacizumab), irinotecan will be administered at the beginning and end of each cycle of chemotherapy, whereas it is normally administered at one time in the regimen. standard of treatment.

The hypothesis of this study is an increase in the objective response rate at 2 months of 10 to 30% with a scheme by FOLFIRINOX3 - bevacizumab compared to an optimal treatment to date by FOLFIRINOX-bevacizumab.

lead_sponsor: Centre Georges Francois Leclerc


title: Long-term Follow-up of Sequential Chemotherapy and Stimulation for Fertility Preservation in Young Patients Treated for a Breast Cancer

summary: Interventional research with low risks and constraints, prospective and monocentric on the assessment of long-term fertility in patients who underwent an adjuvant sequential chemotherapy with or without a controled ovarian hyperstimulation. This study follows a previous one called NCT 01614704.

lead_sponsor: Centre Oscar Lambret


title: Evaluation of the Links Between Sleep Disorders and the Risk of Suicide Attempt

acronym: HYPNOS

summary:
Several studies have demonstrated an association between sleep disorders such as insomnia and nightmares to suicidal ideations and behaviors.

Nevertheless, some of these studies are methodologically questionable especially in the exploration of sleep disorders. Furthermore, confounding factors such as depressive symptomatology are not controlled and the measurement of suicidal behavior has often been taken into account as a historical measure, not as a current event, which introduces uncertainties and a lack of precision regarding the temporality of the phenomena.

Today, while the links between sleep disorders and suicidal risk are well known, we have a lack of information on the importance and the role of sleep disorders as a precipitating factor. Indeed, few studies have evaluated the temporal link between sleep disorders and suicidal acts.

The objective of this study is to evaluate the links between acute and chronic sleep disorders and the risk of suicide attempt


title: Cardio-Respiratory Response of an Exercise Training Session With Ergocycle or Treadmill Compared to an Adapted Physical Activity Session on a Wii, in Patients With Pulmonary Disease

acronym: WIIRR

summary: the aim of this study is to show that training session with nintendo WII requires the same cardiorespiratory demand than training session on ergocycle or treadmill, traditionally used in pulmonary rehabilitation program.

lead_sponsor: University Hospital, Brest


title: Study About Personality, as a Predictive Factor of Therapeutic Response on Quality of Life After Continuous Perfusion of Dopaminergic Drugs (by Subcutaneous Apomorphine Infusion or Intrajejunal Infusion of Levodopa-carbidopa), in Parkinson's Disease

acronym: PSYCHO-PERF

summary: The aim of the study is to evaluate if patients' personality could be considerate as predictive factor of quality of life after the establishment of continuous infusion of dopaminergic treatments to observe if there are predictive personality's profiles of specific therapeutic response (Deep Brain Stimulation (DBS) of the subthalamic nucleus (STN) or continuous infusion).

lead_sponsor: University Hospital, Toulouse


title: Effect of Pulmonary Rehabilitation on Fear of Falling in COPD Patients

acronym: PARACHUTE

summary: The aim of this study is to measure the impact of pulmonary rehabilitation program on fear of falling in COPD patients

ReferenceCitation: Berriet AC, Beaumont M, Peran L, Le Ber C, Couturaud F. Effects of pulmonary rehabilitation on fear of falling in Chronic Obstructive Pulmonary Disease (COPD) patients: An observational study. Respir Med Res. 2022 Jun 12;82:100932. doi: 10.1016/j.resmer.2022.100932. [Epub ahead of print]


title: Individualizing Mean Arterial Pressure of Head Trauma Injury Patients Using an Novel Automated System for Vasopressor Administration : a Randomized Controlled Trial

acronym: COMAT

summary: The goal of this randomized controlled trial will be to show that the use of a novel automated system to guide vasopressor administration in head trauma injury patients will results in more time spent with a mean arterial pressure (MAP) within the predefined MAP compared to patients managed without any automated system (manually management)

status: Withdrawn

lead_sponsor: Erasme University Hospital


title: Oral Health Knowledge and Practice Among 8-9 Years Old Children.

acronym: OHAC

summary:
The aim of this study is to identify the knowledge and behavior on dental health and hygiene among adolescents. In most cases, the investigators know tooth decay can be prevented and reversed at an early stage by observing good oral hygiene. Few studies have been done among adolescents.

This study could justify the implementation of public health actions in terms of prevention.

ipd_sharing_description: NC


title: Discovery of New Biomarkers in Pancreatic Cancer Using Novel Nondestructive OMICS Methodology

acronym: PANEXPEL

summary:
The investigators recently engineered a novel biomarker discovery approach that is non-destructive and fully compatible with OMICS profiling as well as routine clinical procedures (5). The latter approach - termed EXPEL - mines the interstitial tissue fluid that is the richest source of soluble, undiluted and uncontaminated biomarkers. The method notably gives access to proteins, metabolites, RNA, DNA and exosomes, thus enabling holistic biomarker discovery. Owing to its non-destructive nature, EXPEL provides for the first time both clinicians and researchers with the opportunity to analyze identical material.

The investigators hypothesize that the conservation liquid used to collect cells and biopsy after endoscopic ultrasound for pancreatic biopsy could contain the tissue secretome and permit a comprehensive OMICS analysis of PDAC (all stages confounded) by using a "modified EXPEL" procedure. These are ideal conditions for EXPEL approach that will additionally to finding novel biomarkers also shed light on complex network of cancer cell-stroma interactions.

ReferenceCitation: Souche R, Tosato G, Rivière B, Valats JC, Debourdeau A, Flori N, Pourquier D, Fabre JM, Assenat E, Colinge J, Turtoi A. Detection of soluble biomarkers of pancreatic cancer in endoscopic ultrasound-guided fine-needle aspiration samples. Endoscopy. 2022 May;54(5):503-508. doi: 10.1055/a-1550-2503. Epub 2021 Aug 26.


title: In Vivo Biomechanical Analysis of the Practitioner's Motion During a Peripheral Venous Catheter Insertion

acronym: ABGPVVP

summary:
The aim of this study is to analyze the palpation and perforation motion performed by the practitioner during the insertion of a catheter while measuring the loads applied on the skin and the veins.

These experimental measures will be used for the design of a more realistic peripheral venous catheter insertion simulator in order to better prepare healthcare students for their first in vivo venous puncture.

location_facility: Laboratory of Biomechanics and Impact Mechanics - Centre Hospitalier Lyon Sud


title: Efficacy and Safety of Levocetirizine Alone or in Combination With Tranexamic Acid in the Treatment of Spontaneous Chronic Urticaria. Multicentric Controlled Randomized Study in Cross-over, Double-blind

acronym: TACUS

summary:
Spontaneous chronic urticaria (UCS) is a disease that affects 1% of the general population with a potentially severe impact on quality of life. Most patients respond favorably to long-term antihistamine treatment, but sometimes it is necessary to give a high dose (4 times the formal dose, Berlin consensus 2016). These high doses are often accompanied by side effects requiring cessation of treatment. The therapeutic alternative is then omalizumab, an expensive biotherapy. UCS is secondary to non-specific mast cell activation. It has been shown to be associated with activation of fibrinolysis that correlates with the severity of symptoms. Patients with UCS resistant to levocetirizine were shown to have higher D-dimer levels than patients who responded to antihistamines. Tranexamic acid is a molecule with antifibrinolytic propertiesSeveral cases of severe chronic urticaria responding favorably to treatment with tranexamic acid have been reported. In our department, Investigators also noticed the improvement of some of their patients on tranexamic acid. The combination of these two treatments appears to be synergistic: action on histamine receptors and control of fibrinolysis.

The investigators propose to evaluate the association of tranexamic acid and levocetirizine for the treatment of chronic spontaneous urticaria.

lead_sponsor: University Hospital, Grenoble


title: Drains Ablation Post Total Hip Arthroplasty : Search for the Least Painful Technique

acronym: TADDA

summary: Comparison of ablation technique of drains

lead_sponsor: University Hospital, Rouen


title: " Ilomedin for Treatment of Septic Shock With Persistent Microperfusion Defects ", a Double-blind, Randomized Controlled Trial:The I-MICRO Trial

acronym: I-MICRO

summary: Septic shock remains a major cause of death in critically ill patients. Alterations in microcirculation have long been proposed as a key pathophysiological factor of organ dysfunction and death in septic shock patients. Persistence of mottling, prolonged skin recoloration time and cyanosis of the extremities are the easily and frequently observed manifestations of these microcirculatory disorders. Ilomedin is a prostaglandin analog with a potent vasodilatory effect together with anti-thrombotic properties (inhibition of platelet aggregation) preferentially at the microcirculatory level. An increase in cardiac output with increased arterial oxygen delivery has been observed in clinical and preclinical studies with no episodes of hypotension. Improvement in mesenteric perfusion has moreover been observed in experimental sepsis using Ilomedin. Our group has furthermore reported that administration of Ilomedin in patients with refractory septic shock (peripheral hypoperfusion) resulted in a rapid and sustained improvement in peripheral perfusion. Altogether, Ilomedin may prevent or improve recovery of organ dysfunction in septic shock patients through recruitment of the microcirculation and, thereby, ultimately improve outcome.

ReferenceCitation: De Backer D, Donadello K. Assessment of microperfusion in sepsis. Minerva Anestesiol. 2015 May;81(5):533-40. Epub 2014 Jun 19. Review.

ReferenceCitation: Ait-Oufella H, Lemoinne S, Boelle PY, Galbois A, Baudel JL, Lemant J, Joffre J, Margetis D, Guidet B, Maury E, Offenstadt G. Mottling score predicts survival in septic shock. Intensive Care Med. 2011 May;37(5):801-7. doi: 10.1007/s00134-011-2163-y. Epub 2011 Mar 4.

ReferenceCitation: Müller B, Schmidtke M. Microvascular effects of iloprost in the hamster cheek pouch. Adv Prostaglandin Thromboxane Leukot Res. 1987;17A:455-8.

ReferenceCitation: Johannes T, Ince C, Klingel K, Unertl KE, Mik EG. Iloprost preserves renal oxygenation and restores kidney function in endotoxemia-related acute renal failure in the rat. Crit Care Med. 2009 Apr;37(4):1423-32. doi: 10.1097/CCM.0b013e31819b5f4e.

ReferenceCitation: Hoeper MM, Gall H, Seyfarth HJ, Halank M, Ghofrani HA, Winkler J, Golpon H, Olsson KM, Nickel N, Opitz C, Ewert R. Long-term outcome with intravenous iloprost in pulmonary arterial hypertension. Eur Respir J. 2009 Jul;34(1):132-7. doi: 10.1183/09031936.00130408. Epub 2009 Feb 27.

ReferenceCitation: Lara B, Enberg L, Ortega M, Leon P, Kripper C, Aguilera P, Kattan E, Castro R, Bakker J, Hernandez G. Capillary refill time during fluid resuscitation in patients with sepsis-related hyperlactatemia at the emergency department is related to mortality. PLoS One. 2017 Nov 27;12(11):e0188548. doi: 10.1371/journal.pone.0188548. eCollection 2017.

ReferenceCitation: Dépret F, Sitbon A, Soussi S, De Tymowski C, Blet A, Fratani A, Legrand M. Intravenous iloprost to recruit the microcirculation in septic shock patients? Intensive Care Med. 2018 Jan;44(1):121-122. doi: 10.1007/s00134-017-4935-5. Epub 2017 Sep 18.

ReferenceCitation: Legrand M, Oufella HA, De Backer D, Duranteau J, Leone M, Levy B, Rossignol P, Vicaut E, Dépret F; I-MICRO trial investigators. The I-MICRO trial, Ilomedin for treatment of septic shock with persistent microperfusion defects: a double-blind, randomized controlled trial-study protocol for a randomized controlled trial. Trials. 2020 Jul 1;21(1):601. doi: 10.1186/s13063-020-04549-y.

lead_sponsor: Assistance Publique - Hôpitaux de Paris

location_facility: Departement of Anesthesiology, Critical Care and Burn Unit; Saint-Louis hospital


title: Smoking Tobacco Cessation Integrated Program of Patients Treated for the Head and the Neck Cancer: a Controlled Randomized Study

acronym: INTENT

summary: Head and neck squamous cell carcinomas (HNSCCs) arise in the mucosa of the upper aero-digestive tract. They are the 6th most prevalent type of cancer worldwide. The risk related to tobacco is particularly high in the case of HNSCC, as the prevalence of heavy smoking for long periods is high in this population. The investigators' aim is to compare two models: one is a specific model of tobacco cessation intervention designed for health care teams treating patients with HNSCC; the other is the current standard of care for these patients, namely referral to external care after general advice on tobacco cessation. The investigators will evaluate the efficacy of this intervention 12 months after randomization. This intervention will be implemented into otolaryngology (ENT) care by training ENT nurses with a specific program for tobacco cessation delivered to patients diagnosed with HNSCC.


title: Systems Analysis of Antigen Presenting Cells in Human Sepsis.

acronym: DENDRISEPSIS

summary:
Sepsis is a common life-threatening inflammatory response to infection and is the leading cause of death in the intensive care unit. Septic patients exhibit a complex immunosuppressive response affecting both innate and adaptive components of immunity, with a possible link to nosocomial infections. However, the molecular and cellular mechanisms resulting in secondary immunosuppression remain poorly understood, but may involve the antigen-presenting cells (APC, including dendritic cells and monocytes/macrophages) that link innate and adaptive immunity. Furthermore, the increasing phenotypic and functional heterogeneity of APC subsets raise the question of their respective role in sepsis. We propose to address the pathophysiologal role of APC using systems biology approaches in human sepsis.

The objective is to go from low- to high-resolution analysis of APC subset diversity and underlying molecular and functional features in sepsis. The global objective will be reached through:

Systematic description and phenotypic analysis of circulating APC subsets in sepsis
Association of APC subsets distribution, phenotype and function with severe sepsis physiopathology and relevant clinical outcomes (ICU-acquired infections and death)
High-resolution molecular profiling of circulating APC subsets using population level and single cell RNAseq.

To this aim, the investigator designed a prospective interventional study in order to collect blood samples at significant time points in patients with sepsis or septic shock (the population of interest) and relevant control subjects, either critically ill patients with non-septic acute circulatory failure or age-matched healthy subjects. The study's intervention is limited to additional blood samples. The risks and constraints are related to additional blood samples (maximum 120mL), which will be performed either from an arterial catheter when present in ICU patients, or from a venous puncture for patients without arterial catheters and for healthy volunteers.


title: Chronic Cough and Small Fiber Neuropathy

acronym: CHROCOS

summary: Diabetic patients with and without chronic cough will be included in this study. After giving their informed consent, the patients will perform a spirometry, chest X-ray at the inclusion visit. Cough will be assessed using the cough visual analog scale (VAS) and the Leicester Cough Questionnaire (LCQ). Within 60 days, the patient will perform neurophysiological tests. The neurophysiological assessment will be concluded with a skin biopsy to evaluate small fiber neuropathy. The aim of the study is to compare the proportion of small fiber neuropathy between diabetic patients with chronic cough and those without chronic cough.

ReferenceCitation: Chung KF. Chronic 'cough hypersensitivity syndrome': a more precise label for chronic cough. Pulm Pharmacol Ther. 2011 Jun;24(3):267-71. doi: 10.1016/j.pupt.2011.01.012. Epub 2011 Feb 1.

ReferenceCitation: De Santi F, Zoppini G, Locatelli F, Finocchio E, Cappa V, Dauriz M, Verlato G. Type 2 diabetes is associated with an increased prevalence of respiratory symptoms as compared to the general population. BMC Pulm Med. 2017 Jul 17;17(1):101. doi: 10.1186/s12890-017-0443-1.

ReferenceCitation: Pavy-Le Traon A, Fontaine S, Tap G, Guidolin B, Senard JM, Hanaire H. Cardiovascular autonomic neuropathy and other complications in type 1 diabetes. Clin Auton Res. 2010 Jun;20(3):153-60. doi: 10.1007/s10286-010-0062-x. Epub 2010 Mar 31.

ReferenceCitation: Casellini CM, Parson HK, Richardson MS, Nevoret ML, Vinik AI. Sudoscan, a noninvasive tool for detecting diabetic small fiber neuropathy and autonomic dysfunction. Diabetes Technol Ther. 2013 Nov;15(11):948-53. doi: 10.1089/dia.2013.0129. Epub 2013 Jul 27.


title: Patient-ventilator Synchronisation Study in Non Invasive Ventilation for Intensive Care Unit Patients: Comparison Between Manual and Automated Ventilator Settings.

acronym: SyncAutoVNI

summary:
This cross-over study will compare the asynchrony index between standard manual ventilator settings, optimized manual ventilator settings, and automated ventilator setting in intensive care patients ventilated in non-invasive ventilation with a high asynchrony index. The hypothesis is that both manual optimized ventilator settings and automated ventilator settings are associated with a lower patient-ventilator asynchrony index as compared to manual standard ventilator settings.

A randomized cross-over design method will be used. Patient requiring NIV with an asynchrony index over 35% will be included. An esophageal catheter with a balloon will be inserted to monitor esophageal pressure. Patients will be ventilated during 3 periods of 30 min, with 10 minutes of washout in between. Recordings of airway pressure, airway flow, and esophageal pressure will be analyzed by two investigators blinded of the trigger settings.

The primary outcome will be the asynchrony index. The secondary outcome will be the ineffective inspiratory effort index, autotrigering index, double triggering index, inspiratory trigger delay, cycling delay, total time spent in asynchrony, patient comfort, and blood gas results.

ReferenceCitation: Demoule A, Chevret S, Carlucci A, Kouatchet A, Jaber S, Meziani F, Schmidt M, Schnell D, Clergue C, Aboab J, Rabbat A, Eon B, Guérin C, Georges H, Zuber B, Dellamonica J, Das V, Cousson J, Perez D, Brochard L, Azoulay E; oVNI Study Group; REVA Network (Research Network in Mechanical Ventilation). Changing use of noninvasive ventilation in critically ill patients: trends over 15 years in francophone countries. Intensive Care Med. 2016 Jan;42(1):82-92. doi: 10.1007/s00134-015-4087-4. Epub 2015 Oct 13.

ReferenceCitation: Demoule A, Girou E, Richard JC, Taillé S, Brochard L. Increased use of noninvasive ventilation in French intensive care units. Intensive Care Med. 2006 Nov;32(11):1747-55. Epub 2006 Jun 24.

ReferenceCitation: Keenan SP, Sinuff T, Burns KE, Muscedere J, Kutsogiannis J, Mehta S, Cook DJ, Ayas N, Adhikari NK, Hand L, Scales DC, Pagnotta R, Lazosky L, Rocker G, Dial S, Laupland K, Sanders K, Dodek P; Canadian Critical Care Trials Group/Canadian Critical Care Society Noninvasive Ventilation Guidelines Group. Clinical practice guidelines for the use of noninvasive positive-pressure ventilation and noninvasive continuous positive airway pressure in the acute care setting. CMAJ. 2011 Feb 22;183(3):E195-214. doi: 10.1503/cmaj.100071. Epub 2011 Feb 14.

ReferenceCitation: Ferrer M, Valencia M, Nicolas JM, Bernadich O, Badia JR, Torres A. Early noninvasive ventilation averts extubation failure in patients at risk: a randomized trial. Am J Respir Crit Care Med. 2006 Jan 15;173(2):164-70. Epub 2005 Oct 13.

ReferenceCitation: El-Solh AA, Aquilina A, Pineda L, Dhanvantri V, Grant B, Bouquin P. Noninvasive ventilation for prevention of post-extubation respiratory failure in obese patients. Eur Respir J. 2006 Sep;28(3):588-95. Epub 2006 May 31.

lead_sponsor: Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer

location_facility: Centre Hospitalier Intercommunal Toulon La Seyne sur Mer


title: "Impact of a Programme to Improve Interaction Among Professionals on the Management of Task Interruptions"

acronym: IMPACTT

summary:
In 2017, all IMPACTT investigators experimented in coordinated manner on multifacet intervention program, proposed by the present research protocol, with 2 teams from healthcare units from the PDL region. This experiment followed collaborative work aiming to raise team awareness on task interruptions. Given the existing data in the literature, the investigators hypothesise that the implementation of a multifacet program focusing on interactions within a team could enable the percentage of task interruptions linked to interactions between coordination functions and healthcare provision activities to be decreased by 33%. This decrease would concern task interruptions that are avoidable, in order to improve healthcare safety and teamwork.

Also, the main objective of this project is to measure the impact of a program on the evolution of the characteristics of avoidable task interruptions. The project combines quantitative data (observations, questionnaire) and qualitative data (interviews).

lead_sponsor: Nantes University Hospital


title: Feasibility of Immunotherapy Administration to Patients With Bronchial Cancer in a Hospital-at- Home Setting - ImHADom

acronym: ImHADom

summary:
This observational prospective monosite study aims to describe, for the first time, management in a hospital-at-home programme of patients treated by immunotherapy for bronchial cancer.

The feasibility in good conditions of this management, the patients' quality of life and their satisfaction will be evaluated.

lead_sponsor: RENAULT Patrick Aldo


title: Improvement of in Vitro Fertilization Implantation by Soluble CD146 Dose in Embryonic Culture Environment : Multicenter Prospective Study

acronym: AMIFIV

summary:
The study of implantation potential of the embryo stay a priority in In Vitro Fertilization (IVF). Indeed, the selection of embryos to transfer is actually based in routine check on morphologic criteria, approved by literature but not perfect. Implantation's markers identification, allowing to choose the embryo(s) to transfer and then decrease pregnancy failure, represent a major issue in IVF, not any biomarker being approved yet.

Among factors regulating embryonic implantation, investigators have recently proposed soluble CD146, coming from proteolytic cleavage of the CD146 membrane, angiogenic bond molecule.

In a monocentric study about 222 transferred embryos at the end of IVF try, investigators showed that the sCD146 dose in the embryonic culture environment reflected the implantation ability of embryo, a high rate showing a low implantation potential and this independently of the embryonic quality. A multicentric prospective study is now required to confirm the utility of this dosage in clinical practice.

Primary objective : Compared 2 frozen embryo transfer (FET) strategies in terms of implantation efficiency, according to choice method of embryo to be transferred :

Group A : Standard strategy : Depending on embryonic quality according to criteria currently selected.
Group B : Experimental strategy : Association of embryonic quality according to criteria currently selected and of sCD146 rate.

Expected Results :

Demonstrate a beginning pregnancy test significantly superior in Group B compared to Group A.
Confirmed that sCD146 is an independent biomarker of morphologic embryonic quality (actual selection criteria) and represent a complementary criteria to choose embryos to transfer.

Methodology :

- Multicentric prospective study with 2 groups of Frozen Embryo Transfer (FET); The calculation of the number of staff required includes 151 couples per group.

For this will be include for 24 months, couples benefiting of freezing at least one of the two embryos and transfer of only one FET.

Test the same day of environment freezing where frozen embryos were cultivated. sCD146 dosage by ELISA technic (Enzyme Linked ImmunoSorbent Assay) in thus culture environment before FET.
Implantation potential analyze of each transfer embryo (FET) according to sCD146 rate.
Following of the FET future(pregnancy, childbirth) : maximum 9 months after attempt to each included couple.

status: Not yet recruiting

lead_sponsor: Assistance Publique Hopitaux De Marseille


title: R-WITT Study : Revaluation of Wells' Clinical Prediction Score in Inpatients With Thromboprophylaxis Treatment

acronym: R-WITT

summary: This study aimed (1) revaluating the efficacy of the Wells' clinical prediction score for an inpatient population; and the weight of the presence of thromboprophylaxis treatment on the score, and (2) evaluating the correlation of a risk stratification established between a physician specialised in thrombosis and any other doctor.

ReferenceCitation: Trihan JE, Adam M, Jidal S, Aichoun I, Coudray S, Laurent J, Chaussavoine L, Chausserie S, Guillaumat J, Lanéelle D, Perez-Martin A. Performance of the Wells score in predicting deep vein thrombosis in medical and surgical hospitalized patients with or without thromboprophylaxis: The R-WITT study. Vasc Med. 2021 Jun;26(3):288-296. doi: 10.1177/1358863X21994672. Epub 2021 Mar 22.

lead_sponsor: Centre Hospitalier Universitaire de Nīmes


title: Type 2 Innate Lymphoid Cells in Severe Pediatric Asthma

acronym: CLASSE

summary: The main objectives of this study are to show that the number of type 2 innate lymphoid cells (ILC2) of the bronchial mucosa and in bronchoalveolar lavages (BAL) are higher in asthmatic children than in non-asthmatics, that the number of ILC2 of the bronchial mucosa and in BAL correlate with the number of bronchial and BAL eosinophils, and to determine whether there is a correlation between plasma and bronchial and BAL ILC2.


title: Multiple Drug Hypersensitivity Syndrome in a Large Database

acronym: MDH

summary:
Background: Multiple drug hypersensitivity syndrome (MDH) is defined as confirmed drug hypersensitivity reactions (DHRs) to at least 2 chemically and pharmacologically unrelated drugs. Reports of MDH are scarce and poorly specified and studies which diagnose MDH on the basis of positive allergy tests are lacking.

Objective: To evaluate retrospectively the frequency and characteristics of MDH patients in a large database.

Methods: All the patients who consulted and were tested in our Allergy Unit between September 1996 and February 2018, with confirmed MDH will be included. Clinical history and allergy work-up results will be extracted from our Drug Allergy and Hypersensitivity Database (DAHD). The frequency of MDH will be calculated, MDH patients will be described, the most frequent associations of DHRs will be identified and analysed.


title: Secondary Intention Wound Healing Versus Axillary Perforator Flaps for Axillary Reconstruction, After Surgical Wide Excision for Hidradenitis Suppurativa : a Randomized Multicentered Controlled Trial

acronym: HS-PAX

summary:
Hidradenitis Suppurativa (HS) is a recurrent inflammatory disease (< 2 episode /6 months) with 1%-4% prevalence in Europe. Suppurating lesions are painful and involve one or more regions (axilla, genitofemoral, perineum, gluteal areas and inframammary, creases).

For recalcitrant stage II and III, wide surgical skin excision is the only recommended and validated treatment in case inefficacity of medical conventional systemic therapies or limited-local surgery.

Perforator Flaps (PF) surgery, are a new and innovative surgical technique, that, unlike secondary wound healing, allows a single stage reconstruction at the same time as skin excision without its disadvantages.: prolonged healing time, with multiple painful dressings (costs) retractile scar with reduction of the range of motion, dyschromia, unstable and fragile scar.

The hypothesis of study is a 30% reduction of time to healing by using perforators flaps technique (PF) versus wound healing (SIWH), for axillary reconstruction after surgical wide excision in axillary hidradenitis suppurativa stage II or III in adults with inadequate response to conventional systemic therapy.

location_facility: Service PREMIER ( Plastique, Reconstruction, Esthétique, Microchirugie et Régénération tissulaire)CHU TENON- APHP


title: Upper-limb Active Function and Botulinum Toxin A

acronym: ULAFBoT-Stroke

summary: This study in an observational, prospective and longitudinal study. The aim of the study is to evaluate the effect of botulinum toxin type A (BTX) injections into the elbow flexors on the reduction of spastic co-contractions (spastic co-contraction index, SCCI) during an active elbow extension in chronic post-stroke patients.TBA injections are performed as part of routine care


title: Target-controlled Infusion With Propofol in the Emergency Department : a Prospective Study on 45 Adult Patients

acronym: SIVOC

summary:
Procedural sedation is an emergency medicine technique that provides a brief, deep sedation in order to perform very painful emergency emergent procedures such as displaced fracture or dislocated joints reduction. Propofol is recommended for this purpose, injected administered in slow IV bolus injections according to the technique known as manual titration. But despite this precaution, temporarily excessive sedation can happen, and a side effect can appear (arterial hypotension or respiratory depression). Target-controlled infusion (TCI) is an anesthesia technique that permits to obtain a precise constant and stable concentration of medication, boluses volumes of injection being calculated and delivered automatically by an electric syringe equipped with a software obedient to existing pharmacokinetic models. In the operating room, Ffor anesthetic induction, maintenance and awakening, respectively, in the operating room, the brain concentrations of propofol range respectively from 2 to 6 μg/mL, 2 to 4 μg/mL, and between 0.8 and 1.2 μg/mL, respectively. Since TCI has never been used in emergency departments (ED), the brain propofol concentrations which are necessary for sedation and awakening of the patient are not known and must be determined experimentally.

In this single-center, prospective, interventional study, safety and feasibility of TCI will be studied in one ED with the primary objective of determining the brain propofol concentrations necessary to reach the an optimal sedation in for patients with indications of sustaining very painful orthopedic emergency emergent procedures

lead_sponsor: Centre Hospitalier Universitaire de Nice


title: Quality of Life of Frail Aged Patients in Incremental Hemodialysis: a Phase III Study

acronym: Qualifragilys

summary:
End stage renal disease (ESRD) is a major public health problem. The dialysis population is aging. As a result we observe a high prevalence of frailty among dialysis patients (ranges from 3 to 10 fold higher than in the comparably aged general public). Frailty is a medical syndrome characterized by diminished strength, endurance, and reduced physiologic function that increases an individual's vulnerability for developing increased dependency and/or death. Without systematic approach it is difficult for physicians to detect frailty phenotype which however might be reversible or attenuated by interventions. Fried et al. developed a frailty phenotype consisting of 3 or more of: unintentional weight loss, exhaustion, physical inactivity, slow gait speed, and weak grip strength. The primary care of hemodialysis patient is often supported by the nephrologist. Identification of frailty is integrated into the primary care setting as one of the steps necessary for the overall assessment of the person and planning to formal prevention interventions in an individualized care plan. Thrice-weekly hemodialysis (HD) schedules are the standard default hemodialysis prescription in Western countries, imposed in the 70s. For incremental HD, the weekly dose of dialysis is based on variety of clinical factors such as residual kidney function, volume status, cardiovascular symptoms, potassium level, nutritional status and, comorbid conditions. Incremental HD scheme generally starts with 2 weekly sessions and then periodic monitoring of criteria mentioned above are used to determine the timing for increasing dialysis dose and frequency to 3 weekly sessions.

An approach that integrates systematic frailty phenotype assessment by nephrologists and individualized incremental HD therapy can be beneficial within the first year of HD. It could optimize health-related quality of life and other pertinent outcomes without affecting negatively the quality of dialysis. The purpose of this study is to evaluate for frail aged incidents hemodialysis patients the impact of implementation of an incremental HD on HRQoL compared to conventional HD.

ReferenceCitation: Fiteni F, Pam A, Anota A, Vernerey D, Paget-Bailly S, Westeel V, Bonnetain F. Health-related quality-of-life as co-primary endpoint in randomized clinical trials in oncology. Expert Rev Anticancer Ther. 2015;15(8):885-91. doi: 10.1586/14737140.2015.1047768. Epub 2015 May 31.

lead_sponsor: Centre Hospitalier Universitaire de Besancon

location_facility: Centre Hospitalier Universitaire de Besançon


title: Five-year Mortality Rate in People With Diabetic Foot Ulcer

acronym: DIAFOOT

summary:
As the global mortality rate decreases for diabetics patients, further explorations and datas are needed about the specific population of diabetics patients suffering a Diabetic Foot Ulcer (DFU).

This study investigates the 5 years mortality rate in patients with a diabetic foot ulcer occurring in 2010.

lead_sponsor: Groupe Hospitalier Pitie-Salpetriere

location_facility: AP-HP, Pitié-Salpêtrière Hospital, Department of Pharmacology, CIC-1421, Pharmacovigilance Unit, INSERM


title: Interest of an Early Osteopathic Treatment in Infants in the Prevention of Cranial Deformations : Positional Plagiocephaly and Brachycephaly.

acronym: TOPP PLAGIO

summary:
Positional cranial deformities (PCD), plagiocephaly and brachycephaly are a common reason for pediatric consultation, which has increased significantly since the recommendation to lay babies on their backs to prevent unexpected infant death (ILD). CPD is a source of concern for parents about their impact on psychomotor development and the aesthetic risk of deformity. The High Authority for Health (HAS) will soon put in place recommendations with a fact sheet for health professionals and the public. The aim of this research is to study whether early treatment of rotation disorders and hypertonia in newborns by manual osteopathic techniques would prevent the occurrence of positional deformities of the skull.

The main objective is to evaluate the effectiveness of an early osteopathic treatment on the rate of CPP (plagiocephalic and postural brachycephalia) at 4 months in newborns at risk.

the secondary objective is: to evaluate the effectiveness of an early osteopathic treatment on the quality of life of the child at 4 months.

Methodology: Controlled, randomized monocentric two-arm parallel study between (1) osteopathic follow-up and (2) osteopathy-free follow-up. The inclusion period will be 18 months and the follow-up period is 4 months.

Procedure: The two groups will be evaluated at 3 days and 4 months. The experimental group will benefit from an osteopathic treatment of 3 days of life to 4 months with a frequency of 3 to 4 sessions. Both groups will benefit from sleeping, carrying, positioning and stimulation advice.

The perspectives are:

the decrease in the prevalence of CPP after early osteopathic treatment.
Defining a decision algorithm for early osteopathic treatment.
Subject to recommendations on the indication of early osteopathic treatment in neonates at risk.

lead_sponsor: University Hospital, Montpellier


title: Diagnostic Accuracy of the Central Venous Pressure (CVP) Variation to Predict Fluid Responsiveness in Spontaneously Breathing Patients

acronym: VPVC

summary:
Volume expansion (VE) is often administered in intensive care (ICU)-patient to improve arterial oxygen delivery. Such effect is secondary to an increase in stroke volume and cardiac output. However, cardiac output increase in response to VE (fluid responsiveness) only occurs when the heart is preload-dependant. Increasing evidence of the deleterious effects of inappropriate fluid administration encourages the development of variables predicting fluid responsiveness, but few have been validated in spontaneously breathing patients.

Central venous pressure (CVP) variation in spontaneously patients during standardized or unstandardized inspiratory maneuver may represent an easy tool to predict fluid responsiveness. The hypothesise is that inspiratory maneuver may increase CVP variation in fluid responsiveness patient whereas no or few variation may reflect fluid unresponsiveness.

lead_sponsor: University Hospital, Lille


title: Assessment of the Impact of Thoracic Outlet Syndromes on the Performance at Work

acronym: PROCTB

summary: Thoracic outlet syndrome may associate neurologic, arterial and venous symptoms. The responsibility of repetitive movements and postural factors has been mentioned for long. Some tasks are hard to perform, and it seemed interesting to assess the consequences of this syndrome on the work capacity by a questionnaire, at the moment of diagnosis by Echo-Doppler


title: Manual Versus Assisted Fluid Management in Patients Undergoing Major Abdominal and Orthopedic Surgery: A Randomized Controlled Trial

acronym: AFM

summary: This study will compare a group of patients managed with a manual GDFT protocol (using the EV1000 monitoring device; Edwards Lifesciences, Irvine, USA) to a group of patients managed using a decision support system for GDFT guidance (implemented on the same EV1000 monitoring) in patients undergoing major abdominal and orthopedic surgery.


acronym: MMELPOAF

title: Microcirculatory and Macrocirculatory Effects of Landiolol in Prevention of Postoperative Atrial Fibrillation: a Randomized Study.

lead_sponsor: Hospices Civils de Lyon

summary: Postoperative atrial fibrillation is a common complication after cardiac surgery and is associated with an elevation of morbidity and mortality. The recommended treatment includes heart rate control with a beta blocker. Landiolol is a new-generation beta-blocker with favourable pharmacologic properties making an interesting drug to treat postoperative atrial fibrillation. However, Landiolol micro and macrocirculatory effects in the setting of atrial fibrillation are yet to describe. The aim of this study is to describe microcirculatory effects of incremental doses of landiolol in postoperative atrial fibrillation compared to a placebo. Our hypothesis is Landiolol will improve microcirculation disorders.


title: Regulation of CCL18 by Corticosteroids in Severe Asthma

summary: The majority of asthmatic patients are well controlled by inhaled corticosteroid treatment, however some severe asthma resist this treatment. CCL18 is a target gene for corticosteroids and its dysfunction may correlate with phenotypes of asthma.


title: Prospective Study of Incidence and Risk Factors of Infections and of Replacement Therapy With Intravenous Immunoglobulins for Secondary Immunodeficiency in Patients With Autoimmune Diseases Treated With Rituximab

acronym: EXPRIME

summary:
Rituximab is a very effective drug used to treat many inflammatory diseases. These diseases include, for example, rheumatoid arthritis, multiple sclerosis and systemic autoimmune diseases.

The major drawback of this drug is the risk of infection, which are favored by the direct effect of rituximab on the immune system. The risk of infection is one of the major reason not to prescribe or withdraw rituximab in several patients. However, many questions remain unanswered regarding the proportion and risk factors of infection or immunodeficiency induced by rituximab. Better understanding of these issues will help prescribing rituximab and properly monitor patients during their treatment. Moreover, as treatment with substitutive immunoglobulins might be a solution to decrease the risk of infections in those patients, it is very important to better characterize the risk and risk factors of rituximab-associated infection. The present study aims to answer these questions.


title: Retrospective Study of Volumetric Gluteal Region by Parasacral Perforator Flaps in Circuferential Body Lift

summary: The development of bariatric surgery, its effectiveness and the reduction of complications are at the origin of massive weight loss, the corollary of which has been a clear increase in the demands of treatment of sequelae of weight loss.


title: Study of Awareness of Hospices Civils de Lyon Workers About Breast Cancer Screening

summary:
Breast cancer is the most common cancer in French women, with 52000 new cases each year.

Shift work and night work is recognized by International Agency for Research on Cancer as a potential risk factor. Epidemiological studies find, for most of them, an increased risk of breast cancer compared with general population. Physiological hypothesis rely on the melatonin role in defense against tumorigenesis.

According to High Authority of Health clinical good practice guidelines, the risk does not justify more screening than the organized screening. We do not have information about awareness level of workers in health structures, specially in the Hospices Civils de Lyon.

Investigators would like to know how employees take part to breast cancer screening, specially in night workers.

This study, as a survey, is a first step to evaluate the need for specific actions to increase the participation to breast cancer screening.

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


title: Impact of Pollution on Allergic Rhinitis and Sleep Quality: the POLLAR Study

acronym: POLLAR

summary:
It has been demonstrated that allergic rhinitis (AR) reduces sleep quality by some components such as nasal obstruction. Pollution and allergen exposure worsening AR, sleep quality is deteriorated.

Sleep is associated to physical and mental health, alterations in sleep could explain the link between AR and work productivity diminution, impairment in daily activities or emotional problems.

However, interactions between air pollution, sleep and allergic diseases are insufficiently understood.

The main objective of this study is to determine the impact of pollution and pollens on sleep parameters.


title: What is the Regional and Remote Effect of Spinal Manipulation on Pressure Pain Threshold in Asymptomatic Subjects Over Time: A Randomized Placebo-controlled Study

summary: Spinal manipulation is often used for its effect on pain, but more information is needed concerning its mechanisms of action.

lead_sponsor: Institut Franco Europeen de Chiropratique

location_facility: Institut Franco Européen de chiropraxie (iFEC)


title: Safety and Efficacy of Low-dose IL-2 in Birch Pollen Allergy

summary:
Several studies have reported a deficit and/or a defect in regulatory T cells in allergic subjects, which can be correlated with the allergic responses, especially for respiratory allergies. Low-dose IL-2 (ld-IL2) specifically targets and activates regulatory T cells (Tregs), which are cells that regulate immune responses. Thus by stimulating Tregs, ld-IL2 would control allergic responses.

This study is designed to evaluate the efficacy of ILT-101 (ld-IL-2), compared to placebo, on the nasal response assessed by Total Nasal Symptom Score (TNSS) during a controlled birch allergen exposure.


title: Impact of Juvenile Obesity on Emotional Memory and Functional Connectivity Between the Amygdala and the Hippocampus

acronym: OBETEEN

summary: Recent studies indicate that obese teenagers exhibit memory disturbances. Adolescence represents a crucial period in the development of the hippocampus and the amygdala, necessary for the implementation of memory and emotional functions for the rest of life. Disturbances of the interaction between amygdala and hippocampus during adolescence have been associated with the development of neuropsychiatric disorders. However, the impact of juvenile obesity on functional amygdala-hippocampus connectivity has not been evaluated yet. The main objective of this study is to compare the emotional memory performance and the level of functional connectivity between the hippocampus and the amygdala during the realization of an emotional associative memory task, in obese and control adolescents.

ReferenceType: result

ReferenceCitation: Vértes PE, Bullmore ET. Annual research review: Growth connectomics--the organization and reorganization of brain networks during normal and abnormal development. J Child Psychol Psychiatry. 2015 Mar;56(3):299-320. doi: 10.1111/jcpp.12365. Epub 2014 Dec 1. Review.

lead_sponsor: University Hospital, Bordeaux


title: Determine Immunoglobulin G4 (IgG4) Standards for Cow's Milk and Egg in Different Populations of Allergic and Non-allergic Children

summary:
The study objectives are :

Determine standards of plasma levels of casein-specific immunoglobulin G4 (IgG4) and egg-specific immunoglobulin G4 (IgG4) as a function of age, in non-allergic children, in allergic children, and in cured former allergic patients.

Analyze the plasma IgG4 / IgE ratio, according to the result of the oral provocation test (tolerance versus allergy) and, in the event of a reaction, according to the reactogenic dose (dose which caused the reaction).Determine whether analysis of the plasma metabolome can identify children with a cured allergy to cow's milk protein or to egg from those with a persistent allergy.

ReferenceCitation: Adel-Patient K, Lezmi G, Castelli FA, Blanc S, Bernard H, Soulaines P, Dumond P, Ah-Leung S, Lageix F, de Boissieu D, Cortes-Perez N, Hazebrouck S, Fenaille F, Junot C, Dupont C. Deep analysis of immune response and metabolic signature in children with food protein induced enterocolitis to cow's milk. Clin Transl Allergy. 2018 Sep 28;8:38. doi: 10.1186/s13601-018-0224-9. eCollection 2018.


title: LYMPHOSPIR : Impact of Surgery in Addition to Optimal Management of Lymphedema.

acronym: LYMPHOSPIR

summary:
Lymphedema is a chronic pathology with a real impact on the quality of life of patients. Despite optimal medical management of patients, some patients still have no pitting edema on which the medical treatment has no effect.

It is adipose tissue secondary to the evolution of lymphedema. It is often painful and important in terms of volume with the resulting functional consequences. The investigators propose to these patients a surgical management complementary to the optimal medical treatment by microlipoaspiration associated or not with a dermolipectomy. This surgical management began in 2014 in our service. The investigators want to evaluate the impact on quality of life of patients in this surgical management in addition to medical care.


title: Dosage of Progastrin in Asymptomatic Person Participating in Colon Cancer Screening

summary: Dosage of progastrin in asymptomatic person participating in colon cancer screening

ipd_sharing_description: Monocentric study; No IPD sharing

lead_sponsor: ECS-Progastrin SA

location_facility: Centre Hospitalier Princesse Grace, Monaco


title: Activity and Tolerability of Maintenance Avelumab Immunotherapy After First Line Polychemotherapy Including Platinum in Patients With Locally Advanced or Metastatic Squamous Cell Penile Carcinoma

acronym: PULSE

summary:
Patients with unresectable locally advanced or metastatic squamous cell penile carcinoma (SPC) who are in response or with stable disease after first line platinum containing polychemotherapy who meet the inclusion/exclusion criteria will be offered to take part in the study.

The patients may be pre-screened at the time of the 1st line chemotherapy.

In order for patients to be enrolled, the investigator must have carried out a radiological assessment of the disease during first line systemic treatment (a maximum of between 3 and 6 cycles): the cancer must be controlled. Patients with disease progression cannot be included in the PULSE study as this is a maintenance study.

After inclusion, Avelumab will be administered at a dose of 10 mg/kg, at a frequency of once every 2 weeks with appropriate supportive care.

ReferenceCitation: Gassian N, Frontczak A, Mouillet G, Vernerey D, Manseur O, Goujon M, Meurisse A, Berthod D, Robert E, Calcagno F, Thiery-Vuillemin A. Activity and tolerability of maintenance avelumab immunotherapy after first line polychemotherapy including platinum in patients with locally advanced or metastatic squamous cell penile carcinoma: PULSE. Bull Cancer. 2020 Jun;107(5S):eS16-eS21. doi: 10.1016/S0007-4551(20)30282-4.


title: A Non-Randomized, Open Label, One Sequence, Two-Period Cross-Over Study to Investigate the Effect of CYP3A Inhibition on the Pharmacokinetics of RO7017773 in Healthy Participants

summary: The purpose of this study is to investigate the effect of multiple oral doses of itraconazole on the pharmacokinetics of RO7017773 in healthy volunteers.

lead_sponsor: Hoffmann-La Roche


title: A Comparison of Radiofrequency Catheter Ablation With or Without Contact-force and Cryoablation for Paroxysmal Atrial Fibrillation Ablation

acronym: ARCFA

summary: The study aims to compare 3 techniques routinely used for paroxysmal atrial fibrillation ablation: radiofrequency catheter ablation without contact-force, radiofrequency catheter ablation with contact-force and cryoablation. The hypothesis is the non-inferiority between the 3 techniques in terms of free-from atrial fibrillation survival (primary criteria). It will also compare lenght of procedure, radioscopy time and immediate complications (secondary criteria).

lead_sponsor: Centre Hospitalier Régional Metz-Thionville


title: De-escalation of Antifungal Treatment in Immunocompromised Critically Ill Patients With Suspected Invasive Candida Infection: Incidence, Associated Factors, and Safety

acronym: D-ATFIM

summary:
A small proportion of intensive care unit patients receiving antifungals have a proven invasive fungal infection. However, antifungal treatment has side effects such as toxicity, emergence of resistance, and high cost. Moreover, empirical antifungal treatment is still a matter for debate in these patients. Our study aimed to determine the incidence, associated factors, and safety of de-escalation of antifungals in immunocompromised critically ill patients.

This prospective observational study is conducted in 14 ICU, during a 6 months period. All immunocompromised patients hospitalized for >5d and treated with antifungals for suspected or proven invasive candida infection will be included De-escalation is defined as a reduction in antifungal spectrum or stopping initial drugs within the 5 days following their initiation. The three antifungals considered in this study are from the narrowest to the widest spectrum: fluconazole, caspofungin and liposomal amphotericin B.


title: Characterization of Gut Microbiota Composition and Activity After a Daily Supplementation of 4.5 g/Day of ChitinGlucan Fibre During 3 Weeks in At-cardiometabolic Risk Volunteers

acronym: FITACHITIN

summary: The aim of this study is to demonstrate the beneficial effects on gut microbiota composition and activity of the diary intake of insoluble fiber (extract from Aspergillus Niger) for three weeks. The first studies about the fiber have shown a favorable gut microbiota modulation and an improvement of metabolic parameters like LDL cholesterol. In addition to fecal measurements, several biomarkers of colic fermentation will be assessed: expired gases, PolyUnsaturated Fatty Acid, Short Chain Fatty Acid (SCFA) after a rich-fiber breakfast (= 15 grams) and a nutritional challenge test at lunch. The gastrointestinal tolerance of fiber intake and the intestinal transit modification will be also followed during all the study.

location_facility: Centre de Recherche en Nutrition Humaine Rhône-Alpes - Centre hospitalier Lyon Sud


title: Comparison of Inflammatory Profiles and Regenerative Potential in Alcoholic Liver Disease

acronym: TargetOH

summary: The main objective of this study is the comparison of the profile of the pro-inflammatory cytokines at the patients suffering from an alcoholic hepatitis to that of two groups witnesses: patients suffering from an alcoholic cirrhosis and unhurt patients of chronic liver disease


title: Effectiveness of Energy Resonance by Skin Stimulation in the Management of Anxious Patients Who Require Scheduled Orthopaedic Surgery

acronym: ERESCAO

summary:
The need for a surgical procedure may cause a patient to experience reactive anxiety. This reaction is appropriate if it is of low to moderate intensity. On the other hand, various studies have shown that postoperative awakening is more complicated if the patient experiences major preoperative anxiety. Thus, reducing anxiety could be a tool for preventing chronic pain.

For several years now, the investigator's facility has been implementing Energy Resonance through Cutaneous Stimulation (ERCS), a method based on "listening" to the body's vibrations through the fingers on points based on the mapping of meridians in Chinese medicine.

ERCS practitioners have noted the benefits of this method, particularly in soothing patients. It therefore seems necessary to detect and manage this anxiety beforehand and ERCS seems appropriate in this situation.

lead_sponsor: Centre Hospitalier Universitaire Dijon