title: A Multicentric Randomized Trial Comparing the Bronchial Artery Embolization Combined With Medical Measures and the Medical Measures Alone in the Treatment of Non-severe Acute Hemoptysis of Mild-to-moderate Abundance

acronym: ARTEMHYS

summary: Severe hemoptysis is a life-threatening condition, with an unpredictable course. The efficacy of bronchial artery embolization (BAE) is well established for the treatment of severe hemoptysis, with short and long-term bleeding controls obtained in 70 to 100% and 50 to 90% of cases, respectively. As complications related to vascular interventional radiology may occur in 5 to 10% of cases, the benefit-risk balance might be less clear in acute hemoptysis of mild-to-moderate abundance (volume between 100 and 200 ml) and no criteria of severity (respiratory failure or hemodynamic instability). There is no available data comparing the safety and efficacy of BAE combined with medical measures to those of medical measures alone in the treatment of non-severe acute hemoptysis of mild-to-moderate abundance.

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ReferenceCitation: Fartoukh M, Khalil A, Louis L, Carette MF, Bazelly B, Cadranel J, Mayaud C, Parrot A. An integrated approach to diagnosis and management of severe haemoptysis in patients admitted to the intensive care unit: a case series from a referral centre. Respir Res. 2007 Feb 15;8:11.

ReferenceCitation: Savale L, Parrot A, Khalil A, Antoine M, Théodore J, Carette MF, Mayaud C, Fartoukh M. Cryptogenic hemoptysis: from a benign to a life-threatening pathologic vascular condition. Am J Respir Crit Care Med. 2007 Jun 1;175(11):1181-5. Epub 2007 Mar 1.

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ReferenceCitation: Håkanson E, Konstantinov IE, Fransson SG, Svedjeholm R. Management of life-threatening haemoptysis. Br J Anaesth. 2002 Feb;88(2):291-5.

ReferenceCitation: Jean-Baptiste E. Clinical assessment and management of massive hemoptysis. Crit Care Med. 2000 May;28(5):1642-7. Review.

ReferenceCitation: Lordan JL, Gascoigne A, Corris PA. The pulmonary physician in critical care * Illustrative case 7: Assessment and management of massive haemoptysis. Thorax. 2003 Sep;58(9):814-9. Review.

ReferenceCitation: Haponik EF, Chin R. Hemoptysis: clinicians' perspectives. Chest. 1990 Feb;97(2):469-75.

ReferenceCitation: Haponik EF, Fein A, Chin R. Managing life-threatening hemoptysis: has anything really changed? Chest. 2000 Nov;118(5):1431-5.

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ReferenceCitation: Ramon P, Wallaert B, Derollez M, D'Odemont JP, Tonnel AB. [Treatment of severe hemoptysis with terlipressin. Study of the efficacy and tolerance of this product]. Rev Mal Respir. 1989;6(4):365-8. French.

ReferenceCitation: White RI Jr. Bronchial artery embolotherapy for control of acute hemoptysis: analysis of outcome. Chest. 1999 Apr;115(4):912-5.

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ReferenceCitation: Cremaschi P, Nascimbene C, Vitulo P, Catanese C, Rota L, Barazzoni GC, Cornalba GP. Therapeutic embolization of bronchial artery: a successful treatment in 209 cases of relapse hemoptysis. Angiology. 1993 Apr;44(4):295-9.

ReferenceCitation: Uflacker R, Kaemmerer A, Picon PD, Rizzon CF, Neves CM, Oliveira ES, Oliveira ME, Azevedo SN, Ossanai R. Bronchial artery embolization in the management of hemoptysis: technical aspects and long-term results. Radiology. 1985 Dec;157(3):637-44.

ReferenceCitation: Mesurolle B, Lacombe P, Barre O, Qanadli S, Mulot RO, Chagnon S. [Failures and complications of bronchial artery embolization]. Rev Mal Respir. 1996 Jul;13(3):217-25. Review. French.

ReferenceCitation: Ramakantan R, Bandekar VG, Gandhi MS, Aulakh BG, Deshmukh HL. Massive hemoptysis due to pulmonary tuberculosis: control with bronchial artery embolization. Radiology. 1996 Sep;200(3):691-4.

ReferenceCitation: Rabkin JE, Astafjev VI, Gothman LN, Grigorjev YG. Transcatheter embolization in the management of pulmonary hemorrhage. Radiology. 1987 May;163(2):361-5.

ReferenceCitation: Hayakawa K, Tanaka F, Torizuka T, Mitsumori M, Okuno Y, Matsui A, Satoh Y, Fujiwara K, Misaki T. Bronchial artery embolization for hemoptysis: immediate and long-term results. Cardiovasc Intervent Radiol. 1992 May-Jun;15(3):154-8; discussion 158-9.

ReferenceCitation: Swanson KL, Johnson CM, Prakash UB, McKusick MA, Andrews JC, Stanson AW. Bronchial artery embolization : experience with 54 patients. Chest. 2002 Mar;121(3):789-95.

ReferenceCitation: Wong ML, Szkup P, Hopley MJ. Percutaneous embolotherapy for life-threatening hemoptysis. Chest. 2002 Jan;121(1):95-102.

ReferenceCitation: Ong TH, Eng P. Massive hemoptysis requiring intensive care. Intensive Care Med. 2003 Feb;29(2):317-20. Epub 2002 Nov 2.

ReferenceCitation: Labbe V, Roques S, Boughdène F, Razazi K, Khalil A, Parrot A, Fartoukh M. Shock complicating successful bronchial artery embolization for severe hemoptysis. Chest. 2009 Jan;135(1):215-217. doi: 10.1378/chest.08-0491.

ReferenceCitation: Lacerda JE, Consolim-Colombo FM, Moreira ED, Ida F, Silva GJ, Irigoyen MC, Krieger EM. Influence of cardiopulmonary reflex on the sympathetic activity during myocardial infarction. Auton Neurosci. 2007 May 30;133(2):128-35. Epub 2006 Dec 26.

ReferenceCitation: Remy-Jardin M, Bouaziz N, Dumont P, Brillet PY, Bruzzi J, Remy J. Bronchial and nonbronchial systemic arteries at multi-detector row CT angiography: comparison with conventional angiography. Radiology. 2004 Dec;233(3):741-9. Epub 2004 Oct 14.

ReferenceCitation: Yoon YC, Lee KS, Jeong YJ, Shin SW, Chung MJ, Kwon OJ. Hemoptysis: bronchial and nonbronchial systemic arteries at 16-detector row CT. Radiology. 2005 Jan;234(1):292-8. Epub 2004 Nov 18.

ReferenceCitation: Straus DJ, Yahalom J, Gaynor J, Myers J, Koziner B, Caravelli J, Lee BJ 3rd, Nisce LZ, McCormick B, Bajorunas D, et al. Four cycles of chemotherapy and regional radiation therapy for clinical early-stage and intermediate-stage Hodgkin's disease. Cancer. 1992 Feb 15;69(4):1052-60.

ReferenceCitation: JACKSON GG, ARANA-SIALER JA, ANDERSEN BR GRIEBLE HG, McCABE WR. Profiles of pyelonephritis. Arch Intern Med. 1962 Nov;110:63-75.

ReferenceCitation: Fartoukh M, Demoule A, Sanchez O, Tuffet S, Bergot E, Godet C, Andrejak C, Pontier-Marchandise S, Parrot A, Mayaux J, Meyer G, Cluzel P, Sapoval M, Le Pennec V, Carette MF, Cadranel J, Rousseau A, Khalil A, Simon T; ARTEMHYS trial group. Randomised trial of first-line bronchial artery embolisation for non-severe haemoptysis of mild abundance. BMJ Open Respir Res. 2021 Jun;8(1). pii: e000949. doi: 10.1136/bmjresp-2021-000949.

lead_sponsor: Assistance Publique - Hôpitaux de Paris


title: Use of a CMGS to Validate Algorithms for Basal Insulin Rate Reductions in Type 1 Diabetic Patients Treated With Subcutaneous Continuous Insulin Infusion and Practicing Physical Activity

acronym: DIABRASPORT

summary:
Primary aim:

To show that in subjects with type 1 diabetes with a subcutaneous continuous insulin infusion, adjustment of the recommended basal insulin flow rate in the event of physical activity allows the subjects to practice sports without any increase in incidence of hypoglycaemia during physical activity or the ensuing hours.

(NB: hypoglycaemia is defined as blood glucose less than 3 mmol/l or 0,54 g/l in accordance with the EMEA definition).

The proposed algorithms consist of a temporary reduction in basal flow of 50 percent or 80 percent (temporary basal flow TBR50 or TBR80) depending on the intensity of physical activity (50 percent of VO2max or 75 percent of VO2max). Switching off the pump will also be studied as an option to adjust insulin dosage in the event of unprogrammed physical activity (temporary reduction of basal flow by 100 percent).

Secondary aims:

Characterisation of hypoglycaemia during and after physical activity based on CGMS data: symptomatic or non-symptomatic nature of hypoglycaemia, time to onset of hypoglycaemia in relation to the start of physical activity, degree and severity of hypoglycaemia.
Evaluation of overall variations in blood glucose in the event of physical activity using CGMS data (area under the curve).
Evaluation of glucose restoration methods used in the event of hypoglycaemia.
Analysis of subgroups of patients with and without hypoglycaemia.

status: Completed

study_completion_date_type: Actual

study_type: Interventional

design_allocation: Randomized

primary_purpose: Basic Science

enrollment_type: Anticipated

lead_sponsor: Centre d'Etudes et de Recherche pour l'Intensification du Traitement du Diabète

intervention_type: Other

lead_sponsor_type: industriel

status_simplified: Completed


title: Effects of Various Bariatric Surgical Procedures on Intestinal Triglyceride-rich-lipoprotein (TRL) Metabolism in Obese Patients

summary: Morbidly obesity (body mass index 40 kg/m²), the most serious, is more and more frequent. Cardiovascular diseases are the first cause of morbidity and mortality. An excess of TRL particles is one of the characteristics, represents a major cardiovascular risk factor. The overproduction of the intestinal TRL (which apoprotein B48 is the specific tracer) is recently recognized of insulin-resistance and the atherogenous role of these intestinal TRL has been shown. In front of this important overmortality, the bariatric surgery quickly developed. Three main procedures are performed: 2 based exclusively on the gastric restriction (the adjustable gastric banding and the sleeve gastrectomy) and one associating a malabsorption (the gastric bypass).

design_allocation: Non-Randomized

ReferenceType: derived

ReferenceCitation: Padilla N, Maraninchi M, Béliard S, Berthet B, Nogueira JP, Wolff E, Nicolay A, Bégu A, Dubois N, Grangeot R, Mattei C, Vialettes B, Xiao C, Lewis GF, Valéro R. Effects of bariatric surgery on hepatic and intestinal lipoprotein particle metabolism in obese, nondiabetic humans. Arterioscler Thromb Vasc Biol. 2014 Oct;34(10):2330-7. doi: 10.1161/ATVBAHA.114.303849. Epub 2014 Aug 7.

lead_sponsor: Assistance Publique Hopitaux De Marseille

location_facility: Assistance Publique - Hopitaux de Marseille

intervention_type: Procedure

lead_sponsor_type: academique


title: High Frequency rTMS (Repetitive Transcranial Magnetic Stimulation) Effect Applied on Primary Cortical Motor, on Nociceptive Perception Thresholds in Parkinson's Disease Patients: a Physiopathology Study

acronym: rTMS

summary:
Pain is a frequent symptom in Parkinson's disease. Previous studies have shown that pain perception was altered in Parkinson's disease patients and could be related to nociceptive cortical area hyperactivation. Repetitive Transcranial Magnetic Stimulation is an electrophysiological tool which can modify cortical excitability. Its efficacy was demonstrated in neuropathic pain. This is a randomized, double blind cross-over study. In this study, subjective pain threshold (using thermal stimulation (Thermotest)).will be evaluated in 3 groups of subjects: healthy volunteers, painful Parkinson's patients and pain free Parkinson's disease patients. Each group will receive a high frequency Repetitive Transcranial Magnetic Stimulation and placebo stimulation in different order with a gap of one week.

The investigators supposed that a 20 Hz Repetitive Transcranial Magnetic Stimulation session with an infraliminary intensity on the primary cortical motor, modulating nociceptive cortical areas activity, could modify the nociceptive threshold perception in Parkinson's patients.

enrollment_type: Actual

lead_sponsor: University Hospital, Toulouse

intervention_type: Device


summary: The objectives of this work are: 1/to estimate the frequency of a positive glucose breath test in favour of a small intestinal bacterial overgrowth in a population of patients consulting for gaz incontinence by comparison to a population of control subjects; 2/to estimate versus a conventional treatment the efficiency of an antibiotic treatment; in case of small intestinal bacterial overgrowth diagnosed by the glucose breath test, to improve gaz incontinence

primary_purpose: Treatment

lead_sponsor: University Hospital, Rouen

location_facility: Physiology Unit, Hopital Charles Nicolle, 1 rue de Germont

intervention_type: Drug


title: Study of the Role of Intraventricular Electrical Activation in the Treatment of Congestive Heart Failure by Cardiac Resynchronization Therapy: Invasive Evaluation and Validation of Non-Invasive Strategy Using CardioInsight ®

acronym: CARTO-CRT

summary: Impact of intraventricular electrical activation in resynchronization therapy. We seek to evaluate the impact of Cardiac Resynchronization Therapy (CRT) on electrical activation of the Left Ventricle (LV). The first goal of the study is to evaluate if CRT is able to decrease the heterogeneity of LV activation in heart failure patients. A second goal is to evaluate the electrical determinant of clinical response to CRT using invasive and non-invasive mapping technology.

ReferenceCitation: Huntjens PR, Ploux S, Strik M, Walmsley J, Ritter P, Haissaguerre M, Prinzen FW, Delhaas T, Lumens J, Bordachar P. Electrical Substrates Driving Response to Cardiac Resynchronization Therapy: A Combined Clinical-Computational Evaluation. Circ Arrhythm Electrophysiol. 2018 Apr;11(4):e005647. doi: 10.1161/CIRCEP.117.005647.

lead_sponsor: University Hospital, Bordeaux

location_facility: Hôpital cardiologique du Haut-Lévêque, Pr. Haïssaguerre's department, 3rd Floor


title: Validation of a Non Invasive methylateDNA Test for te Diagnosis of Colorectal Tumour in Asymptomatic Individuals

acronym: VATNIMAD

summary: Screening campaigns for colorectal cancer (CRC) involve two steps: the detection of occult blood in stools using a Hemoccult GAIAC test (FOBT) on three consecutive stool samples, followed by colonoscopy if the result is positive. The information quality of the Hemoccult test, however, is poor: in the asymptomatic 50 to 74 year-old population, the detection sensitivity of polyps more than 1 cm in diameter is of the order of 10 to 30% and is 35 to 50% for detecting colorectal cancers; specificity is 94 to 98% that of a complete colonoscopy. The I-FOBTs based on immunological detection and quantification of occult blood in stools are currently being evaluated; based on the threshold it can be more sensitive than FOBT, but enhances useless colonoscopies. Alternatively, with highest threshold of blood in stools, it may become highly specific and miss less advanced polyps. Faecal molecular tests based on the detection of human DNA anomalies (point gene mutations, methylation disorders of CG islets) appear to be more sensitive than the detection of occult blood in stools with no loss of specificity, but they are very expensive, thereby limiting their generalisation to the scale of population screening. A formal methylated DNA test has been validated in stools as well as in blood in a cohort of symptomatic individuals having undergone colonoscopy. The aim of the present study is to validate this test by taking advantage of the biotechnical expertise from renowned academic research teams and mass screening organisation.

study_type: Observational

time_perspective: Prospective

ReferenceCitation: Sobhani I, Bergsten E, Charpy C, Chamaillard M, Mestivier D. Virulent Bacteria as Inflammatory and Immune Co-Factor in Colon Carcinogenesis: Evidence From Two Monozygotic Patients and Validation in CRC Patient and Healthy Cohorts. Front Cell Infect Microbiol. 2021 Nov 4;11:749750. doi: 10.3389/fcimb.2021.749750. eCollection 2021.

ReferenceCitation: Sobhani I, Bergsten E, Couffin S, Amiot A, Nebbad B, Barau C, de'Angelis N, Rabot S, Canoui-Poitrine F, Mestivier D, Pédron T, Khazaie K, Sansonetti PJ. Colorectal cancer-associated microbiota contributes to oncogenic epigenetic signatures. Proc Natl Acad Sci U S A. 2019 Nov 26;116(48):24285-24295. doi: 10.1073/pnas.1912129116. Epub 2019 Nov 11.


title: Soluble Forms and Ligands of the Receptor for Advanced Glycation End Products (RAGE) in the Pulmonary Edema Fluid and Plasma From ICU Patients With ALI/ARDS : an Observational Prospective Study.

acronym: SoLiRAGE

summary: RAGE, the receptor for advanced glycation end products, is a novel marker of alveolar epithelial type I cell injury. Soluble RAGE (sRAGE) is elevated in the plasma and in the pulmonary edema fluid from patients with ALI/ARDS, but one should acknowledge that the RAGE/NF-B axis is also involved in the pathophysiology of various other conditions. Few data are available about the levels of soluble forms and ligands of RAGE in the setting of ALI/ARDS. The purpose of this observational prospective study is to describe soluble forms (sRAGE, esRAGE) and ligands of RAGE (HMGB-1, S100A12, AGEs) levels in ICU patients with ALI/ARDS.

time_perspective: Cross-Sectional

ReferenceCitation: Jabaudon M, Blondonnet R, Roszyk L, Pereira B, Guérin R, Perbet S, Cayot S, Bouvier D, Blanchon L, Sapin V, Constantin JM. Soluble Forms and Ligands of the Receptor for Advanced Glycation End-Products in Patients with Acute Respiratory Distress Syndrome: An Observational Prospective Study. PLoS One. 2015 Aug 14;10(8):e0135857. doi: 10.1371/journal.pone.0135857. eCollection 2015.

lead_sponsor: University Hospital, Clermont-Ferrand


type: Other Identifier

title: DESHYDRAT : Assessment of the Prevalence of Dehydration Among 9 to 11 Year-old Children.

acronym: DESHYDRAT

summary: The aim of the study is to determinate the prevalence of moderate dehydration among children aged 9 to 11 who are going to school.

lead_sponsor: Rennes University Hospital


summary: Microaspirations of the oropharyngeal ± gastric contents through the endotracheal tube cuff contribute to the constitution of VAP. The pepsin has been recently proved effective as a surrogate of gastric content and was assessed in tracheal secretions. However, the pepsin dosage is fastidious, expensive and only characterizes aspirations from gastric origin. The aim of our study is to asses whether the value of amylase, which is mostly secreted by salivary glands, may turn out to be a new and simpler surrogate for microaspirations in ventilated ICU patients. Thirty patients ventilated for an anticipated length > 48h whose endotracheal tube includes a subglottic secretion device and producing sufficient endotracheal aspirations will be included. From H48, 4 sets of 3 aspirations each (oral, subglottic, tracheal) will be performed during one ventilation day for amylase dosage purpose. In ten of these patients, a comparison between pepsin and amylase will be assessed. In addition, 10 non intubated patients with an indication to bronchoscopy and necessitating a tracheal aspiration during the procedure will be included as a control group. The primary assessment criteria will be the oral/tracheal amylase ratio.

primary_purpose: Diagnostic

lead_sponsor: Université Victor Segalen Bordeaux 2


summary: To rapidly adapt or deescalate the initially broad antibiotic treatment, an antibiogram analysis is required. E test strips have successfully provided an antibiogram 24 h after having been directly applied to bronchoalveolar lavage (BAL). An open-label, prospective cohort study of consecutive patients with hospital-acquired pneumonia will be conducted with the aim of validating a new method increasing the rapidity of antibiogram analysis compared to standard methods of culture. This antibiogram will be provided by E test strips directly applied to bronchoalveolar lavage (BAL) samples and analyzed from the 6th up to the 24th hour after its completion. The occurrence of major errors (S with E test method, I or R with standard method) and minor errors (I or R with E test method and S with standard method)will be observed and a comparison of H6, H10 and H24 results performed.

ReferenceCitation: Boyer A, Goret J, Clouzeau B, Romen A, Prevel R, Lhomme E, Vargas F, Hilbert G, Bébéar C, Gruson D, M'Zali F. Tailoring Empirical Antimicrobial Therapy in Subjects With Ventilator-Associated Pneumonia With a 10-Hour E-Test Approach. Respir Care. 2019 Mar;64(3):307-312. doi: 10.4187/respcare.06255. Epub 2018 Dec 11.


title: Impact of the Time of Oral Nutritional Supplements (ONS) Consumption on Daily Alimentary Intakes of Malnourished Elderly Subjects Hospitalized in Long Term Care Unit (LTCU)

acronym: ACTICLAN

summary: Malnutrition is a severe comorbidity in hospitalised patients, especially in elderly. The consumption of Oral Nutritional Supplements (NOS) is one of several tools for fighting against malnutrition. Their use is easy, and framed by recent French recommendations suggesting to propose NOS at end of meals or as snacking . Nevertheless, there is no scientific data to affirm which is the best of these two hypothesis in elderly hospitalised in Long Term Care Unit(LTCU) . Moreover, a preliminary survey of NOS consumption in LTCU in Limoges university hospital showed some problems about the mode of supplying NOS, partially linked with an insufficiency for paramedical staff in realizing importance of NOS. However, the effect of time of supplying NOS on total food consumption had not been evaluated in this first study. The new one will include 48 malnourished elderly patients in two LTCU and having a prescription of NOS. They will receive them at the same quantity during the whole study either firstly at end of meals (10 days) and secondly as snackings (10 days), or conversely. Order of choice will be randomised. Total daily alimentary intakes will be noted by paramedical staff of the two units, and translated by dieticians in daily energy, protein, carbohydrates and lipids intakes. The time of supplying NOS will be confronted with these intakes, in order to precise the best one.

lead_sponsor: University Hospital, Limoges

location_facility: Unité de Nutrition - Service hépato-gastro-entérologie


title: Predictive Value of FDG-TEP During Radiotherapy (RT) or Chemo-radiotherapy (CRT) in Patients With Non Small Cell Lung Cancer on the One-year Survival

summary:
The poor prognosis in the early-stage of lung cancer is due to potential worsening of the disease (local relapse, metastasis), to insufficient efficacy and toxicity of actual treatments.

FDG-PET is a medical imaging modality allowing the quantification of the tumour glucose consumption. Then, this exam is used for pathology staging, target volume definition for RT, and treatment efficiency few months after RT or CRT. Our assumption is that an FDG-PET exam during the course of the RT or CRT might be predictive of the treatment efficiency few months later.

In this study, the investigators propose to perform 4 FDG-PET: first "PET1" before radiotherapy, second "PET2" during the radiotherapy (see RTEP1), third and fourth "PET3" "PET4" 3month and 12 month after the therapy.

The investigators will investigate the performances of FDG-PET performed during the RT or CRT for the prediction of the one-year patient heath outcome. If the predictive value of TEP2 is confirmed, the investigators would be able to optimize the planning treatment during the course of the therapy.

ReferenceCitation: Ganem J, Thureau S, Gardin I, Modzelewski R, Hapdey S, Vera P. Delineation of lung cancer with FDG PET/CT during radiation therapy. Radiat Oncol. 2018 Nov 12;13(1):219. doi: 10.1186/s13014-018-1163-2.

ReferenceCitation: Calais J, Thureau S, Dubray B, Modzelewski R, Thiberville L, Gardin I, Vera P. Areas of high 18F-FDG uptake on preradiotherapy PET/CT identify preferential sites of local relapse after chemoradiotherapy for non-small cell lung cancer. J Nucl Med. 2015 Feb;56(2):196-203. doi: 10.2967/jnumed.114.144253. Epub 2015 Jan 8.

ReferenceCitation: Vera P, Mezzani-Saillard S, Edet-Sanson A, Ménard JF, Modzelewski R, Thureau S, Meyer ME, Jalali K, Bardet S, Lerouge D, Houzard C, Mornex F, Olivier P, Faure G, Rousseau C, Mahé MA, Gomez P, Brenot-Rossi I, Salem N, Dubray B. FDG PET during radiochemotherapy is predictive of outcome at 1 year in non-small-cell lung cancer patients: a prospective multicentre study (RTEP2). Eur J Nucl Med Mol Imaging. 2014 Jun;41(6):1057-65. doi: 10.1007/s00259-014-2687-9. Epub 2014 Feb 22.

ipd_sharing: No

lead_sponsor: Centre Henri Becquerel


title: Study of the Modification of the Fixation of FDG, F-Miso and FLT Measured in PET/CT at Patients Before and in the Course of Exclusive Radiotherapy or Concomitant Radiochemotherapy for Primitive Bronchial Cancer

summary:
Study of the modification of the fixation(binding) of Fluoro-2-deoxy-D-glucose (FDG), fluoro-misonidazole (FMISO) and 3'deoxy-3-fluoro-thymidine deoxy-3-fluoro-thymidine (FLT) measured in tomography by broadcast(emission,issue) of positrons (PET) at patients before and in the course of exclusive radiotherapy or concomitant radiochemotherapy for primitive bronchial cancer.

This protocle allows to study the simultaneous variations of the metabolism, the hypoxie and the cellular proliferation by PET SCAN at 5 patients reached(affected) by a primitive bronchial cancer in the course of exclusive radiotherapy for primitive bronchial cancer not small cell lung.

The investigators are also going to study several scenarii of optimization of the radiotherapy according to the variations of the tumoral metabolism, the hypoxie and the cellular proliferation measured in the course of radiotherapy (theoretical study on console using the scanner and the various examinations).


title: Prospective Randomized Study of Compression Stockings in Ankle Sprain in Adults

acronym: CASED

summary: This is a multicenter prospective randomized superiority controlled trial comparing leg stockings and standard care to standard care of ankle sprain and testing the hypothesis that compression stockings enable to reduce the median of recovery from ankle sprain by at least 6 days.

ReferenceCitation: Bendahou M, Khiami F, Saïdi K, Blanchard C, Scepi M, Riou B, Besch S, Hausfater P. Compression stockings in ankle sprain: a multicenter randomized study. Am J Emerg Med. 2014 Sep;32(9):1005-10. doi: 10.1016/j.ajem.2014.05.054. Epub 2014 Jun 12.


title: Echocardiographic Assessment of Volume Variation Secondary to Preoperative Fasting

summary: The primary objective of this study is to demonstrate that preoperative fasting does not increase the rate of lowered blood volume (defined by a variation of 15% ΔITV during a leg lift) in patients undergoing surgery.

ReferenceCitation: Muller L, Brière M, Bastide S, Roger C, Zoric L, Seni G, de La Coussaye JE, Ripart J, Lefrant JY. Preoperative fasting does not affect haemodynamic status: a prospective, non-inferiority, echocardiography study. Br J Anaesth. 2014 May;112(5):835-41. doi: 10.1093/bja/aet478. Epub 2014 Feb 3.

lead_sponsor: Centre Hospitalier Universitaire de Nīmes

location_facility: Centre Hospitalier Universitaire de Nîmes


title: Observation of the Gait Cycle in Patients With Hemiplegia in Order to Improve the Triggering of Functional Electrical Stimulation

acronym: MASEA

summary: The main objective of this study is the estimation and comparison of the dephasing between the switch heel and the inertial placed on the paretic foot compared to the events of the gait cycle determined by a Gaitrite system (beginning and end of the swing phase) in conditions without stimulation.


title: Effects of an Individualized Training Program on Severity Markers of Obstructives Sleep Apnea/Hypopnea Syndrome (OSAS)

acronym: REEVASAS

summary: There are two types of treatments depending on the severity of Obstructive Sleep Apnea/Hypopnea Syndrome (OSAS): - for the treatment of severe (AHI> 30/h), the standard treatment is Continuous Positive Airway Pressure (CPAP). If it proved effective in reducing excessive daytime sleepiness and associated cardiovascular risk, compliance of patients 4 years of treatment falls below 70%. - Treatment of moderate (AHI between 15 and 30/h), lifestyle measures, the bracing of mandibular advancement and / or possibly the head and neck surgery can be proposed. These treatments include side effects and their effectiveness is very controversial.Il therefore seemed interesting to test the impact of physical activity through a standardized training program to re personal effort on the development and improvement of OSAS patients with a sedentary moderate to severe OSAS (AHI between 15 and 40 / h) The main assumption is that the ESR could eventually delay the initiation of treatment with CPAP in severe OSAS or an alternative therapeutic relevance in the moderate OSAS and severe in patients who can not tolerate conventional treatment(CSF). The main objective of this biomedical research is to evaluate the effects of a program of REE in ambulatory index of hourly apneas / hypopneas (AHI = marker of severity of OSAS) .- objectives specify 2AIR effects of REE on the quality of sleep (TxSLP) and daytime symptoms (EDS objective fatigue) on the one hand and the other on the metabolism (OV, SM, IR) and markers of LCR (inflammation, oxidative stress , endothelial function).

ReferenceCitation: Bughin F, Desplan M, Mestejanot C, Picot MC, Roubille F, Jaffuel D, Mercier J, Jaussent I, Dauvilliers Y. Effects of an individualized exercise training program on severity markers of obstructive sleep apnea syndrome: a randomised controlled trial. Sleep Med. 2020 Jun;70:33-42. doi: 10.1016/j.sleep.2020.02.008. Epub 2020 Feb 18.

lead_sponsor: University Hospital, Montpellier


title: Adaptation to Nocturnal Noninvasive Ventilation in Patients With Chronic Respiratory Failure

acronym: ROOMILA

summary:
BACKGROUND: Adaptation to noninvasive ventilation (NIV) is a critical step for acceptability and efficacy of this treatment during sleep in patients with chronic respiratory failure.

AIM: To study the variability of patient-ventilator interactions during the first nights after initiation to NIV. Recorded data will be analyzed in part by dedicated tools from the non-linear dynamics theory.

PATIENTS AND METHODS: Patients with chronic respiratory failure at stable state and indicated to home NIV will be included. All patients will perform three polysomnographies (under spontaneous breathing at D1 and under NIV at D2 and D15 after NIV initiation). All ventilatory physiological data (pressure, flow, patient-ventilator interactions, oxygen saturation, non intentional leaks) will be recorded during sleep under NIV in the Sleep Laboratory of the Department and secondarily related to sleep architecture and quality of sleep.

EXPECTED RESULTS: This study will identify objective parameters that are associated to a satisfactory adaptation to nocturnal NIV.

lead_sponsor: Groupe de Recherche sur le Handicap Respiratoire

location_facility: Pulmonary & Respiratory Intensive Care Department - Rouen University Hospital


title: Evaluation of the Continuous Measurement of Tissular (StO2) and Cerebral (ScO2) Oxygenation During Lung Surgery and During the 6 First Postoperative Hours (Prospective Monocentric Study).

summary: The purpose of this study is to compare the ability of two peripheral and non invasive devices to detect hypoxic events during one-lung ventilation and during the early postoperative period. One device measures regional cerebral oxygenation and the other muscular oxygenation. These two devices are compared to non invasive arterial saturation (SpO2), which is the gold standard.

ReferenceType: background

ReferenceCitation: Manfredini F, Malagoni AM, Felisatti M, Mandini S, Mascoli F, Manfredini R, Basaglia N, Zamboni P. A dynamic objective evaluation of peripheral arterial disease by near-infrared spectroscopy. Eur J Vasc Endovasc Surg. 2009 Oct;38(4):441-8. doi: 10.1016/j.ejvs.2009.06.011. Epub 2009 Jul 21.

ReferenceCitation: Mesquida J, Masip J, Gili G, Artigas A, Baigorri F. Thenar oxygen saturation measured by near infrared spectroscopy as a noninvasive predictor of low central venous oxygen saturation in septic patients. Intensive Care Med. 2009 Jun;35(6):1106-9. doi: 10.1007/s00134-009-1410-y. Epub 2009 Jan 29.

ReferenceType: result

ReferenceCitation: Kazan R, Bracco D, Hemmerling TM. Reduced cerebral oxygen saturation measured by absolute cerebral oximetry during thoracic surgery correlates with postoperative complications. Br J Anaesth. 2009 Dec;103(6):811-6. doi: 10.1093/bja/aep309.

ReferenceCitation: Hemmerling TM, Kazan R, Bracco D. Inter-hemispheric cerebral oxygen saturation differences during thoracic surgery in lateral head positioning. Br J Anaesth. 2009 Jan;102(1):141-2. doi: 10.1093/bja/aen336.

lead_sponsor: Hopital Foch


title: Physiological Study on Glutamine and Leucine Effects on Intestinal Protein Metabolism

acronym: Intesmetapro

summary: Gut protein metabolism that could be influenced by protein supply is involved in the regulation of several physiological functions such as gut barrier function and represents a major contribution in the whole-body protein turnover. Intracellular pathways implicated in the transduction of amino acids effects remained unknown in the human gut. Thus, the aim of the present project is to evaluate and to understand the effects of amino acids (glutamine, leucine) on gut protein metabolism (synthesis and degradation) in young healthy humans.

ReferenceCitation: Goichon A, Bertrand J, Chan P, Lecleire S, Coquard A, Cailleux AF, Vaudry D, Déchelotte P, Coëffier M. Enteral delivery of proteins enhances the expression of proteins involved in the cytoskeleton and protein biosynthesis in human duodenal mucosa. Am J Clin Nutr. 2015 Aug;102(2):359-67. doi: 10.3945/ajcn.114.104216. Epub 2015 Jun 24.

ReferenceCitation: Bertrand J, Goichon A, Chan P, Azhar S, Lecleire S, Donnadieu N, Vaudry D, Cailleux AF, Déchelotte P, Coëffier M. Enteral glutamine infusion modulates ubiquitination of heat shock proteins, Grp-75 and Apg-2, in the human duodenal mucosa. Amino Acids. 2014 Apr;46(4):1059-67. doi: 10.1007/s00726-014-1670-x. Epub 2014 Jan 22.

ReferenceCitation: Coëffier M, Claeyssens S, Bôle-Feysot C, Guérin C, Maurer B, Lecleire S, Lavoinne A, Donnadieu N, Cailleux AF, Déchelotte P. Enteral delivery of proteins stimulates protein synthesis in human duodenal mucosa in the fed state through a mammalian target of rapamycin-independent pathway. Am J Clin Nutr. 2013 Feb;97(2):286-94. doi: 10.3945/ajcn.112.046946. Epub 2013 Jan 2.

ReferenceCitation: Coëffier M, Claeyssens S, Bensifi M, Lecleire S, Boukhettala N, Maurer B, Donnadieu N, Lavoinne A, Cailleux AF, Déchelotte P. Influence of leucine on protein metabolism, phosphokinase expression, and cell proliferation in human duodenum1,3. Am J Clin Nutr. 2011 Jun;93(6):1255-62. doi: 10.3945/ajcn.111.013649. Epub 2011 Apr 20.

location_facility: Centre d'Investigation Clinique - Hôpital charles Nicolle


title: Paradoxical Reactions During Anti-mycobacterial Treatment of Extrapulmonary Tuberculosis in Non Immuno-compromized Patients : Clinical, Radiological et Immunological

acronym: PARATB

summary: Tuberculous paradoxical reactions (PR) are immune reactions occurring during the course of antituberculous treatment and leading to a worsening of tuberculous symptoms after an initial improvement. This phenomenon has very extensively studied in HIV infected patients where it corresponds to the so called IRIS (immune reconstitution syndrome). However, it laso occurs in non immuno-compromized patients, especially those with extra-pulmonary localization of tuberculosis. The aim of the study is to look for risk factors of paradoxical reaction in non immuno-compromized patients with extra-pulmonary tuberculosis. The investigators will consider clinical, radiological and biological variables, including specific immune and genetic markers. Our secondary goals are to estimate the incidence of PR, describe their natural history; characterize the type of immune response they correspond to, and look for better diagnostic tools.The immunological characterization and the finding of predictive factors of PR, especially the genetic ones will allow a better understanding of biological mechanisms that lead to their occurrence during extra-pulmonary tuberculosis treatment. The establishment of predictive criteria could permit a better surveillance of at risk patients for a rapid treatment, or even a prevention of PR. The establishment of new diagnostic criteria at the time of PR could avoid numerous invasive diagnostic procedures, surgery and/or useless prolongation of antibiotic treatment.

study_start_date_type: Actual

intervention_type: Radiation


title: French Observatory Syndromes Tako-Tsubo

acronym: OFSETT

summary: Tako Tsubo syndrome (TTS) is characterized by the occurrence in the context of mental or physical stress, a clinical and ECG of acute myocardial infarction without significant coronary artery stenosis, accompanied by a disorder Acute, reversible left ventricular who takes on a characteristic apical ballonnisation evoking the image of a Japanese octopus trap called Tako (octopus) tsubo (jar). Pathophysiology of unknown changes immediate life-threatening prognosis is often good in the longer term.

ReferenceCitation: Kurisu S, Sato H, Kawagoe T, Ishihara M, Shimatani Y, Nishioka K, Kono Y, Umemura T, Nakamura S. Tako-tsubo-like left ventricular dysfunction with ST-segment elevation: a novel cardiac syndrome mimicking acute myocardial infarction. Am Heart J. 2002 Mar;143(3):448-55.

ReferenceCitation: Tsuchihashi K, Ueshima K, Uchida T, Oh-mura N, Kimura K, Owa M, Yoshiyama M, Miyazaki S, Haze K, Ogawa H, Honda T, Hase M, Kai R, Morii I; Angina Pectoris-Myocardial Infarction Investigations in Japan. Transient left ventricular apical ballooning without coronary artery stenosis: a novel heart syndrome mimicking acute myocardial infarction. Angina Pectoris-Myocardial Infarction Investigations in Japan. J Am Coll Cardiol. 2001 Jul;38(1):11-8.

ReferenceCitation: Sharkey SW, Lesser JR, Zenovich AG, Maron MS, Lindberg J, Longe TF, Maron BJ. Acute and reversible cardiomyopathy provoked by stress in women from the United States. Circulation. 2005 Feb 1;111(4):472-9.

ReferenceCitation: Parodi G, Del Pace S, Carrabba N, Salvadori C, Memisha G, Simonetti I, Antoniucci D, Gensini GF. Incidence, clinical findings, and outcome of women with left ventricular apical ballooning syndrome. Am J Cardiol. 2007 Jan 15;99(2):182-5. Epub 2006 Nov 14.

ReferenceCitation: Gianni M, Dentali F, Grandi AM, Sumner G, Hiralal R, Lonn E. Apical ballooning syndrome or takotsubo cardiomyopathy: a systematic review. Eur Heart J. 2006 Jul;27(13):1523-9. Epub 2006 May 23. Review.

ReferenceCitation: El Mahmoud R, Mansencal N, Pilliére R, Leyer F, Abbou N, Michaud P, Nallet O, Digne F, Lacombe P, Cattan S, Dubourg O. Prevalence and characteristics of left ventricular outflow tract obstruction in Tako-Tsubo syndrome. Am Heart J. 2008 Sep;156(3):543-8. doi: 10.1016/j.ahj.2008.05.002. Epub 2008 Jul 7.

ReferenceCitation: Eitel I, Behrendt F, Schindler K, Kivelitz D, Gutberlet M, Schuler G, Thiele H. Differential diagnosis of suspected apical ballooning syndrome using contrast-enhanced magnetic resonance imaging. Eur Heart J. 2008 Nov;29(21):2651-9. doi: 10.1093/eurheartj/ehn433. Epub 2008 Sep 27.

ReferenceCitation: Yayehd K, N'da NW, Belle L, Bataille V, Hanssen M, Leddet P, Aupetit JF, Commeau P, Filippi E, Georges JL, Albert F, Rangé G, Meimoun P, Marcaggi X, Baleynaud S, Nallet O, Dibie A, Barnay C, Jouve B, Legrand M, Cattan S, Mulak G, Simon T, Danchin N, Dujardin JJ; OFSETT investigators. Management of Takotsubo cardiomyopathy in non-academic hospitals in France: The Observational French SyndromEs of TakoTsubo (OFSETT) study. Arch Cardiovasc Dis. 2016 Jan;109(1):4-12. doi: 10.1016/j.acvd.2015.08.004. Epub 2015 Oct 23.

lead_sponsor: French Cardiology Society


title: Stent For Life Observatory

acronym: SFL

summary: Observatory multicenter, prospective, to support the acute phase of acute coronary syndromes with ST segment elevation ST (myocardial infarction).

ReferenceCitation: Cambou JP, Simon T, Mulak G, Bataille V, Danchin N. The French registry of Acute ST elevation or non-ST-elevation Myocardial Infarction (FAST-MI): study design and baseline characteristics. Arch Mal Coeur Vaiss. 2007 Jun-Jul;100(6-7):524-34.

ReferenceCitation: Simon T, Verstuyft C, Mary-Krause M, Quteineh L, Drouet E, Méneveau N, Steg PG, Ferrières J, Danchin N, Becquemont L; French Registry of Acute ST-Elevation and Non-ST-Elevation Myocardial Infarction (FAST-MI) Investigators. Genetic determinants of response to clopidogrel and cardiovascular events. N Engl J Med. 2009 Jan 22;360(4):363-75. doi: 10.1056/NEJMoa0808227. Epub 2008 Dec 22.


title: Study on the Appropriateness of Bariatric Surgery in Adolescents

summary: single-center study carried out in order to evaluate in prospective among patients seen or treated in the pediatric endocrinology unit and multidisciplinary management of obesity, the potential number of patients eligible for surgery.

status: Terminated

status_simplified: Unknown


title: Has the Quota of Signet Ring Cells an Influence on Prognosis and Treatment Strategy in the Upper GI Tract Adenocarcinomas?

summary:
Background • A major increase in incidence of signet ring cell adenocarcinomas (ADCI) of the upper digestive tract in western countries

Discordant results in the literature concerning the prognosis value of the presence of signet ring cells.
Preliminary data suggesting (i) an advanced stage at time of diagnosis, (ii) more often in the form of carcinose, (iii) a more pejorative prognosis, (iv) a recurrence more frequent, more quickly, and more often in the form of peritoneal carcinose, (v) a chemo resistance (vi) the need for a specific therapeutic strategy compared to non-signet ring cell adenocarcinomas.

Primary objective To test the hypothesis that 5-year survival rate is significantly lower in the signet ring cells (SRC) adenocarcinoma when compared to non-SRC adenocarcinoma in the upper digestive tract

Secondary objectives

Impact of neoadjuvant CT on overall survival
Impact and differential diagnostic value of linitis
R0 resection rates
3 years recurrence free survival
Overall 3 years survival
Prognostic factors
Prognostic value of the presence of a minority quota of signet ring cell
Objective response rate after medical treatment (chemotherapy, radiochemotherapy) in non-resected patients
Tolerance of (radio) chemotherapy for ADCI

Methodology Intention to treat retrospective case-control multicentric study A pairing on demographic criteria (age, sex, ASA score, center) and tumor criteria (TNM stage) will be done to ensure comparability in case control study groups.

Inclusion criteria All consecutive patients taken care of, for a proven histologically adenocarcinoma (ADCI and ADNCI) of the esophagus, the esogastric junction, or the stomach, in surgical or medical oncology investigator centers, will be saved in a given database.

For whom the first consultation took place between January 1997 and January 2010

Exclusion criteria Histological type other than adenocarcinoma Other localization than esogastric junction, esophagus or stomach

Planned study period The data will be collected over a period from January 1997 to January 2010.

The objective is to complete the data collection for summer 2010.

time_perspective: Retrospective

ReferenceCitation: Robb WB, Messager M, Goere D, Pichot-Delahaye V, Lefevre JH, Louis D, Guiramand J, Kraft K, Mariette C; FREGATWorking Group-FRENCH. Predictive factors of postoperative mortality after junctional and gastric adenocarcinoma resection. JAMA Surg. 2013 Jul;148(7):624-31. doi: 10.1001/jamasurg.2013.63.

ReferenceCitation: Messager M, Lefevre JH, Pichot-Delahaye V, Souadka A, Piessen G, Mariette C; FREGAT working group - FRENCH. The impact of perioperative chemotherapy on survival in patients with gastric signet ring cell adenocarcinoma: a multicenter comparative study. Ann Surg. 2011 Nov;254(5):684-93; discussion 693. doi: 10.1097/SLA.0b013e3182352647.

lead_sponsor: University Hospital, Lille


title: Impact of Raltegravir on the Viral Reservoirs

summary:
The objective of the antiretroviral treatment is to inhibit the viral replication, estimated(appreciated) by the measure of the viral plasmatic load(responsibility). In this inhibition of the viral replication usually joins an immune reconstruction [ 1 ]. Nevertheless, a viro-immunological dissociation, i.e. an undetectable viral load(responsibility) and an absence of immune reconstruction, is regularly observed. It is now turned out that an undetectable viral load(responsibility) does not correspond to the total absence of viral replication and that it is possible to detect of the intracellular pro-viral DNA . Raltegravir ®, because of its mode of action(share) inhibiting the integration of the pro-viral DNA in the chromosomes of the infected cells(units) , could decrease the intracellular reservoir of monocyte-macrophages, improve the homeostasis, so optimizing the cooperation lymphocytes T - macrophages. Several experimental data suggest that the regression of the abnormalities of cellular interactions, and the rate of apoptose abnormally raised(abnormally brought up) by cells(units) T at the patients in viro-immunological dissociation, could be obtained .

This study aims at measuring the impact of Raltegravir ® on the viral reservoirs lymphocyte and monocyte, to quantify the expression of the molecules of costimulation, the source(spring) of intercellular interactions lymphocytes - monocytes, and to measure the rate of apoptose of the cells(units) T.

status: Unknown status

study_completion_date_type: Anticipated

lead_sponsor: Centre Hospitalier Universitaire de Nice


title: Metabolic Impact of the Digestion of Fat in Emulsified vs Non-emulsified Form in Lean or Obese Volunteers

acronym: LIPINFLOX

summary:
In this study, the investigators are interested in investigating how the emulsification state and amount of fat in a meal can modify the kinetics of postprandial lipemia and inflammatory outcomes (including endotoxemia) in obese vs lean subjects.

10 lean and 10 obese volunteers will come 3 times (>3 weeks apart) at the investigation center to receive a standard breakfast containing milk fat (10 g non emulsified, or 40 g non emulsified, or 40 g finely emulsified). 13C triglyceride stable isotopes will allow to follow the metabolic fate of fatty acids and calculate lipid oxidation by breath test. Blood sampling throughout digestion will allow to measure metabolic, lipid and inflammation parameters. Stool will be analysed to determine lipid losses in faeces and to phenotype microbiota.

ReferenceCitation: Vors C, Drai J, Pineau G, Laville M, Vidal H, Laugerette F, Michalski MC. Emulsifying dietary fat modulates postprandial endotoxemia associated with chylomicronemia in obese men: a pilot randomized crossover study. Lipids Health Dis. 2017 May 25;16(1):97. doi: 10.1186/s12944-017-0486-6.

ReferenceCitation: Vors C, Pineau G, Drai J, Meugnier E, Pesenti S, Laville M, Laugerette F, Malpuech-Brugère C, Vidal H, Michalski MC. Postprandial Endotoxemia Linked With Chylomicrons and Lipopolysaccharides Handling in Obese Versus Lean Men: A Lipid Dose-Effect Trial. J Clin Endocrinol Metab. 2015 Sep;100(9):3427-35. doi: 10.1210/JC.2015-2518. Epub 2015 Jul 7.

ReferenceCitation: Vors C, Drai J, Gabert L, Pineau G, Laville M, Vidal H, Guichard E, Michalski MC, Feron G. Salivary composition in obese vs normal-weight subjects: towards a role in postprandial lipid metabolism? Int J Obes (Lond). 2015 Sep;39(9):1425-8. doi: 10.1038/ijo.2015.71. Epub 2015 Apr 28.

ReferenceCitation: Vors C, Pineau G, Gabert L, Drai J, Louche-Pélissier C, Defoort C, Lairon D, Désage M, Danthine S, Lambert-Porcheron S, Vidal H, Laville M, Michalski MC. Modulating absorption and postprandial handling of dietary fatty acids by structuring fat in the meal: a randomized crossover clinical trial. Am J Clin Nutr. 2013 Jan;97(1):23-36. doi: 10.3945/ajcn.112.043976. Epub 2012 Dec 12.

lead_sponsor: Hospices Civils de Lyon

location_facility: Hospices Civils de Lyon,Centre de Recherche en Nutrition Humaine Rhône-Alpes (CRNH-RA)


type: Registry Identifier

title: Protein Need and Interest of " Quick Proteins " to the Obese Subject Operated by Bariatric Surgery (BIBOP)

acronym: BIBOP

summary: The main objective of the study is to evaluate the protein requirement associated with postoperative weight loss caused by by-pass (shunt which leads to a certain degree of malabsorption) or sleeve gastrectomy (more technically conservative with less malabsorption), through the study of nitrogen balance. The benefit of protein supply easily absorbed and with high essential amino acids content (proteins "fast" soluble milk) on protein metabolism and muscle function will also be studied. Endotoxemia and intestinal flora variations were measured before and after bariatric surgery.

primary_purpose: Other

ReferenceCitation: Guillet C, Masgrau A, Mishellany-Dutour A, Blot A, Caille A, Lyon N, Pereira B, Slim K, Robert M, Disse E, Feugier N, Le Ruyet P, Louvet C, Miolanne M, Farigon N, Laville M, Boirie Y. Bariatric surgery affects obesity-related protein requirements. Clin Nutr ESPEN. 2020 Dec;40:392-400. doi: 10.1016/j.clnesp.2020.06.007. Epub 2020 Oct 1.


title: A Prospective Clinical Study of a Cohort of Pathological Patients Seeking Treatment for a Behavioral Addiction in the University Hospital of Nantes

acronym: EVALADD

summary: This research aims to provide a better understanding of the factors associated with the evolution of behavioral addictions, and compliance with care. The investigators thus aim to follow patients with several types of behavioral addictions, based on addictive, sociodemographic, clinical and endophenotypical characteristics, as well as their care adhesion.

status: Recruiting

time_perspective: Other

lead_sponsor: Nantes University Hospital

status_simplified: Ongoing


summary: The etiopathogenesis of periodontal disease results from complex interaction between infectious agents, mainly including bacteria, and host cellular and humoral immune responses. However it is thought that bacteria-induced pathogenesis is not sufficient alone to explain all biological and clinical features of the destructive periodontal disease. The main hypothesis is that herpesviruses, such as Epstein-Barr Virus, may participate as well by altering epithelial gingival cell biology and consequently may promote the initiation and progression of periodontitis.


primary_purpose: Health Services Research


title: Study of the Cutaneous Microcirculation: ASIC Involvement.

summary:
Pressure ulcers are a common and costly problem. Advancing the understanding regarding the basic pathophysiological mechanisms mediating the development of pressure ulcers will allow for better delineation of populations at risk.

Healthy skin is protected from pressure-induced ischemic damage because of the presence of pressure-induced vasodilation (PIV). In contrast, in absence of PIV, such as in diabetic patients or older subjects with sensory neuropathy, the skin is exposed to severe cutaneous ischemia, which could lead to pressure ulcer formation.

Since Acid Sensing Ion channels (ASICs) appear to be involved in the cutaneous mechanosensitivity, the investigators hypothesized that PIV could be altered by treatments that block ASICs.

ReferenceCitation: Fromy B, Lingueglia E, Sigaudo-Roussel D, Saumet JL, Lazdunski M. Asic3 is a neuronal mechanosensor for pressure-induced vasodilation that protects against pressure ulcers. Nat Med. 2012 Aug;18(8):1205-7. doi: 10.1038/nm.2844. Epub 2012 Jul 29.

location_facility: Pôle d'activité medicale-Centre Hospitalier Lyon Sud-Hospices Civils de Lyon


title: Pilot Study of Lapatinib (Tyverb®) in Neoadjuvant Treatment for Patients With Locally Bladder Carcinoma Before Cystectomy

acronym: LAPAINBLAD

summary: Modification of the EGF signalling pathway and / or HER 2, by Lapatinib in bladder cancer.

ReferenceCitation: Rödel C, Weiss C, Sauer R. Trimodality treatment and selective organ preservation for bladder cancer. J Clin Oncol. 2006 Dec 10;24(35):5536-44. Review.

ReferenceCitation: Jimenez RE, Hussain M, Bianco FJ Jr, Vaishampayan U, Tabazcka P, Sakr WA, Pontes JE, Wood DP Jr, Grignon DJ. Her-2/neu overexpression in muscle-invasive urothelial carcinoma of the bladder: prognostic significance and comparative analysis in primary and metastatic tumors. Clin Cancer Res. 2001 Aug;7(8):2440-7.

ReferenceCitation: Advanced Bladder Cancer (ABC) Meta-analysis Collaboration. Neoadjuvant chemotherapy in invasive bladder cancer: update of a systematic review and meta-analysis of individual patient data advanced bladder cancer (ABC) meta-analysis collaboration. Eur Urol. 2005 Aug;48(2):202-5; discussion 205-6. Epub 2005 Apr 21.

location_facility: CHU Bordeaux - Hôpital Saint André - Department of Medical Oncology


title: Assessment of the Ease of Use of Norditropin NordiFlex® Relative to the One of the Device Previously Used by Patients or Parents

lead_sponsor: Novo Nordisk A/S

type: EudraCT Number

source: euctr

ReferenceCitation: Tauber M, Jaquet D, Jesuran-Perelroizen M, Petrus M, Bertrand AM, Coutant R; NordiFlex® French Study Group. User assessment of Norditropin NordiFlex(®), a new prefilled growth hormone pen: a Phase IV multicenter prospective study. Patient Prefer Adherence. 2013 May 24;7:455-62. doi: 10.2147/PPA.S43460. Print 2013. Erratum in: Patient Prefer Adherence. 2013 Aug 19;7:803.

summary: This study is conducted in Europe. The aim of this study is to compare the easiness of use of Norditropin NordiFlex® device to the device previously used by patients or parents.


title: Evaluation of Oxygen Therapy Delivery Systems in Hypoxemic Acute Respiratory Failure

acronym: OPTI O2

summary: The main objective of this study is to evaluate the efficiency of the oxygen therapy delivery system Optiflow® compared to 2 others standard oxygen therapy delivery systems (Ospal®, non invasive ventilation).12 immunocompetent patients will compare the successive use of oxygen therapy delivery systems Optiflow®/Ospal® and 12 immunodeficient patients will compare the successive use of systems Optiflow®/Non invasive ventilation.


title: Étude Comparative, randomisée, Double-insu, en Groupes parallèles évaluant l'efficacité d'Eductyl® Versus Placebo Chez Des Patients Souffrant d'Une dyschésie

acronym: EDUCDYS

summary: The purpose of this study is to assess the efficacy of Eductyl versus placebo for treatment of patients with dyschesia.

lead_sponsor: Laboratoires Techni Pharma

location_facility: Hôpital Foch, Service de Chirurgie Générale et Digestive


title: Assessment of Desogestrel for a Pharmacological Recovery of Ventilatory Activity in Congenital Central Hypoventilation Syndrome - Ondine Syndrome

acronym: RESPIRONDINE

summary:
The congenital central hypoventilation syndrome (CCHS), also known as the Ondine syndrome, is a very rare genetic disorder. In contrast with healthy people, patients do not increase breathing in response to an excess of carbon dioxide (CO2). As a consequence, they do not breath sufficiently, or even stop breathing, during sleep. Their survival depends only on mechanical respiratory assistance, all life long.

We have recently published two cases of recovery of a response to CO2 in patients taking desogestrel as a contraceptive pill. The goal of the study is therefore to assess the hypothesis that desogestrel will restore a respiratory response to CO2 in CCHS patients and allow them to breath sufficiently during sleep without mechanical assistance.

ReferenceCitation: Sharman M, Gallea C, Lehongre K, Galanaud D, Nicolas N, Similowski T, Cohen L, Straus C, Naccache L. The cerebral cost of breathing: an FMRI case-study in congenital central hypoventilation syndrome. PLoS One. 2014 Sep 30;9(9):e107850. doi: 10.1371/journal.pone.0107850. eCollection 2014.

ReferenceCitation: Straus C, Similowski T. Congenital central hypoventilation syndrome and desogestrel: a call for caution: addendum to "C. Straus, H. Trang, M.H. Becquemin, P. Touraine, T. Similowski, Chemosensitivity recovery in Ondine's curse syndrome under treatment with desogestrel" [Respir. Physiol. Neurobiol. 171 (2010) 171-174]. Respir Physiol Neurobiol. 2011 Sep 15;178(2):357-8. doi: 10.1016/j.resp.2011.07.007. Epub 2011 Jul 23. Review.

lead_sponsor: Assistance Publique - Hôpitaux de Paris


title: Phase II Trial of Temozolomide in Elderly Patients With Glioblastoma and Poor Performance Status (KPS<70).

acronym: TAG

summary: The management of glioblastoma in elderly patients with poor performance status (KPS<70) is unsettled. This single arm phase 2 trial trial was designed to evaluate the efficacy and safety of temozolomide alone in this population


acronym: ScS-REINBO

title: Effect of Bosentan in the Course of Scleroderma Renal Crisis

location_facility: Pôle de médecine interne Centre de référence Maladies rares Groupe I Maladies systémiques et maladies auto-immunes rares en particulier Vascularites nécrosantes et les sclérodermies - Hôpital Cochin

summary: Systemic sclerosis (SSc) is a connective tissue disease characterized by excessive collagen deposition, autoimmunity and by vascular hyper-reactivity and obliterative microvascular phenomena that involves multiple organs. Scleroderma Renal Crisis (SRC) occurs in 5% of patients and mainly with diffuse cutaneous SSc. The routine use of angiotensin-converting enzyme inhibitors (ACEI) has been reported to dramatically improve outcome, with a fall of the 12-month mortality from 76% to less than 15% in the United-States. Despite prognostic improvement, SRC remains a severe manifestation of SSc and functional outcome and survival remains poor. Bosentan is a specific, orally active, dual endothelin receptor antagonist that has recently been approved for the treatment of primary pulmonary arterial hypertension and for the prevention of ischemic digital ulcers. Bosentan could have therapeutic benefits on others vascular injuries and particularly in SRC.


title: Prognosis Value of Transient Elastography and Non-invasive Markers of Fibrosis in Patients With Chronic Liver Disease. A Prospective Follow-up of 4,935 Person-years

acronym: PVTE

summary: The aim of this prospective study was to compare the 5-year prognostic value of transient elastography (TE), FibroTest (FT), APRI , FIB-4, Lok, and Child-Pugh scores for predicting survival and complications of cirrhosis in patients with chronic liver diseases.

ReferenceCitation: Vergniol J, Boursier J, Coutzac C, Bertrais S, Foucher J, Angel C, Chermak F, Hubert IF, Merrouche W, Oberti F, de Lédinghen V, Calès P. Evolution of noninvasive tests of liver fibrosis is associated with prognosis in patients with chronic hepatitis C. Hepatology. 2014 Jul;60(1):65-76. doi: 10.1002/hep.27069.

ReferenceCitation: Vergniol J, Foucher J, Terrebonne E, Bernard PH, le Bail B, Merrouche W, Couzigou P, de Ledinghen V. Noninvasive tests for fibrosis and liver stiffness predict 5-year outcomes of patients with chronic hepatitis C. Gastroenterology. 2011 Jun;140(7):1970-9, 1979.e1-3. doi: 10.1053/j.gastro.2011.02.058. Epub 2011 Mar 2.

lead_sponsor: Association HGE CHU Bordeaux Sud

location_facility: Centre d'Investigation de la Fibrose hépatique Service Hepato-Gastroentérologie Hopital Haut-Leveque


title: Effect of Whole Grain Inclusion in the Diet on Abdominal Fat Regain After a Weight Loss Diet

summary:
Epidemiological studies suggest that whole grain consumption affects measures of obesity including BMI, body fat tissue, and body weight. Most cross-sectional studies demonstrate rather consistently an inverse association between BMI and whole grain consumption. Furthermore, prospective cohort studies suggest that people with high whole grain consumption have less risk for body weight gain compared with low whole grain consumption.

The purpose of this study is to assess the effects of inclusion of whole grain in the diet on anthropometric measures, particularly abdominal fat regain after a weight loss diet.

It is anticipated that the short-term regain of abdominal fat after a weight loss diet is lower in volunteers consuming whole grain than in volunteers consuming refined grain.

lead_sponsor: Cereal Partners Worldwide


title: French Registry of Acute Coronary Syndrome With or Without ST Elevation 2010

acronym: FAST-MI 2010

summary:
The observatory FAST MI 2010 proposes to establish a cohort of 3500 patients recruited prospectively over a period of 2 months.

Patients will be followed up at 1 month and then followed annually for 10 years.

Patients should have agreed to participate in the study, participation in the protocol, or refusal to participate will not affect the therapeutic approach of the physician. The study of genotypic or phenotypic characteristics will not change the therapeutic approach of health care teams.

status: Active, not recruiting

ReferenceCitation: Simon T, Verstuyft C, Mary-Krause M, Quteineh L, Drouet E, Méneveau N, Steg PG, Ferrières J, Danchin N, Becquemont L; French Registry of Acute ST-Elevation and Non-ST-Elevation Myocardial Infarction (FAST-MI) Investigators. Genetic determinants of response to clopidogrel and cardiovascular events. N Engl J Med. 2009 Jan 22;360(4):363-75. doi: 10.1056/NEJMoa0808227. Epub 2008 Dec 22.

ReferenceCitation: Danchin N, Fauchier L, Marijon E, Barnay C, Furber A, Mabo P, Bernard P, Blanc JJ, Jouven X, Le Heuzey JY, Charbonnier B, Ferrières J, Simon T; French registry of Acute ST-elevation and non-ST-elevation Myocardial Infarction (FAST-MI) Investigators. Impact of early statin therapy on development of atrial fibrillation at the acute stage of myocardial infarction: data from the FAST-MI register. Heart. 2010 Nov;96(22):1809-14. doi: 10.1136/hrt.2010.201574.

ReferenceCitation: Zeller M, Danchin N, Simon D, Vahanian A, Lorgis L, Cottin Y, Berland J, Gueret P, Wyart P, Deturck R, Tabone X, Machecourt J, Leclercq F, Drouet E, Mulak G, Bataille V, Cambou JP, Ferrieres J, Simon T; French Registry of Acute ST-Elevation and Non-ST-Elevation Myocardial Infarction investigators. Impact of type of preadmission sulfonylureas on mortality and cardiovascular outcomes in diabetic patients with acute myocardial infarction. J Clin Endocrinol Metab. 2010 Nov;95(11):4993-5002. doi: 10.1210/jc.2010-0449. Epub 2010 Aug 11.

ReferenceCitation: Danchin N, Coste P, Ferrières J, Steg PG, Cottin Y, Blanchard D, Belle L, Ritz B, Kirkorian G, Angioi M, Sans P, Charbonnier B, Eltchaninoff H, Guéret P, Khalife K, Asseman P, Puel J, Goldstein P, Cambou JP, Simon T; FAST-MI Investigators. Comparison of thrombolysis followed by broad use of percutaneous coronary intervention with primary percutaneous coronary intervention for ST-segment-elevation acute myocardial infarction: data from the french registry on acute ST-elevation myocardial infarction (FAST-MI). Circulation. 2008 Jul 15;118(3):268-76. doi: 10.1161/CIRCULATIONAHA.107.762765. Epub 2008 Jun 30.

ReferenceCitation: Hanssen M, Cottin Y, Khalife K, Hammer L, Goldstein P, Puymirat E, Mulak G, Drouet E, Pace B, Schultz E, Bataille V, Ferrières J, Simon T, Danchin N; FAST-MI 2010 Investigators. French Registry on Acute ST-elevation and non ST-elevation Myocardial Infarction 2010. FAST-MI 2010. Heart. 2012 May;98(9):699-705. doi: 10.1136/heartjnl-2012-301700.

ReferenceCitation: Puymirat E, Aissaoui N, Simon T, Bataille V, Drouet E, Mulak G, Ferrières J, Danchin N. [Acute myocardial infarction in the elderly. The FAST-MI registry]. Presse Med. 2013 Nov;42(11):1432-41. doi: 10.1016/j.lpm.2013.04.010. Epub 2013 Jul 22. Review. French.

ReferenceCitation: Simon T, Puymirat E, Lucke V, Bouabdallaoui N, Lognoné T, Aissaoui N, Cohen S, Ashrafpoor G, Roul G, Jouve B, Levy G, Charpentier S, Grollier G, Ferrières J, Danchin N; au nom des investigateurs FAST-MI 2010. [Acute myocardial infarction in women. Initial characteristics, management and early outcome. The FAST-MI registry]. Ann Cardiol Angeiol (Paris). 2013 Aug;62(4):221-6. doi: 10.1016/j.ancard.2013.06.003. Epub 2013 Jul 4. French.

ReferenceCitation: Puymirat E, Teixeira N, Simon T, Steg PG, Schiele F, Lamblin N, Probst V, Juillière Y, Ferrières J, Danchin N; FAST-MI investigators. Patient education after acute myocardial infarction: cardiologists should adapt their message--French registry of acute ST-elevation or non-ST-elevation myocardial infarction 2010 registry. J Cardiovasc Med (Hagerstown). 2015 Nov;16(11):761-7. doi: 10.2459/JCM.0000000000000092.

ReferenceCitation: Puymirat E, Schiele F, Ennezat PV, Coste P, Collet JP, Bonnefoy-Cudraz E, Roul G, Richard P, Simon T, Danchin N. Impact of fondaparinux versus enoxaparin on in-hospital bleeding and 1-year death in non-ST-segment elevation myocardial infarction. FAST-MI (French Registry of Acute ST-elevation and non-ST-elevation Myocardial Infarction) 2010. Eur Heart J Acute Cardiovasc Care. 2015 Jun;4(3):211-9. doi: 10.1177/2048872614544857. Epub 2014 Jul 29.

ReferenceCitation: Puymirat E, Aissaoui N, Cottin Y, Vanzetto G, Carrié D, Isaaz K, Valy Y, Tchetche D, Schiele F, Steg PG, Simon T, Danchin N. Effect of coronary thrombus aspiration during primary percutaneous coronary intervention on one-year survival (from the FAST-MI 2010 registry). Am J Cardiol. 2014 Dec 1;114(11):1651-7. doi: 10.1016/j.amjcard.2014.08.039. Epub 2014 Sep 16.

ReferenceCitation: Puymirat E, Schiele F, Steg PG, Blanchard D, Isorni MA, Silvain J, Goldstein P, Guéret P, Mulak G, Berard L, Bataille V, Cattan S, Ferrières J, Simon T, Danchin N; FAST-MI investigators. Determinants of improved one-year survival in non-ST-segment elevation myocardial infarction patients: insights from the French FAST-MI program over 15 years. Int J Cardiol. 2014 Nov 15;177(1):281-6. doi: 10.1016/j.ijcard.2014.09.023. Epub 2014 Sep 28.

ReferenceCitation: Puymirat E, Caudron J, Steg PG, Lemesle G, Cottin Y, Coste P, Schiele F, de Labriolle A, Bataille V, Ferrières J, Simon T, Danchin N; FAST-MI investigators. Prognostic impact of non-compliance with guidelines-recommended times to reperfusion therapy in ST-elevation myocardial infarction. The FAST-MI 2010 registry. Eur Heart J Acute Cardiovasc Care. 2017 Feb;6(1):26-33. doi: 10.1177/2048872615610893. Epub 2016 Sep 20.

ReferenceCitation: Bailleul C, Puymirat E, Aissaoui N, Schiele F, Ducrocq G, Coste P, Blanchard D, Brasselet C, Elbaz M, Steg PG, Le Breton H, Bonnefoy-Cudraz E, Montalescot G, Cottin Y, Goldstein P, Ferrières J, Simon T, Danchin N; FAST-MI Investigators. Factors Associated With Infarct-Related Artery Patency Before Primary Percutaneous Coronary Intervention for ST-Elevation Myocardial Infarction (from the FAST-MI 2010 Registry). Am J Cardiol. 2016 Jan 1;117(1):17-21. doi: 10.1016/j.amjcard.2015.09.043. Epub 2015 Oct 23.

ReferenceCitation: Sokoloff A, Lefèvre G, Teixeira N, Puymirat E, Beygui F, Vanzetto G, Richard P, Khalife K, Blanchard D, Gilard M, Coste P, Farah B, Elbaz M, Leclercq F, Ferrari E, Bonnet JL, Meyer P, Belle L, Funck F, Motreff P, Virot P, Geugniaud PY, Ferrières J, Simon T, Danchin N. [Characteristics and management of ST-elevation myocardial infarction in France: Regional variations in 2010]. Ann Cardiol Angeiol (Paris). 2015 Dec;64(6):427-33. doi: 10.1016/j.ancard.2015.10.001. Epub 2015 Nov 5. French.

ReferenceCitation: Puymirat E, Lamhaut L, Bonnet N, Aissaoui N, Henry P, Cayla G, Cattan S, Steg G, Mock L, Ducrocq G, Goldstein P, Schiele F, Bonnefoy-Cudraz E, Simon T, Danchin N. Correlates of pre-hospital morphine use in ST-elevation myocardial infarction patients and its association with in-hospital outcomes and long-term mortality: the FAST-MI (French Registry of Acute ST-elevation and non-ST-elevation Myocardial Infarction) programme. Eur Heart J. 2016 Apr 1;37(13):1063-71. doi: 10.1093/eurheartj/ehv567. Epub 2015 Nov 17.

ReferenceCitation: Massoullié G, Wintzer-Wehekind J, Chenaf C, Mulliez A, Pereira B, Authier N, Eschalier A, Clerfond G, Souteyrand G, Tabassome S, Danchin N, Citron B, Lusson JR, Puymirat É, Motreff P, Eschalier R. Prognosis and management of myocardial infarction: Comparisons between the French FAST-MI 2010 registry and the French public health database. Arch Cardiovasc Dis. 2016 May;109(5):303-10. doi: 10.1016/j.acvd.2016.01.012. Epub 2016 Apr 20.

ReferenceCitation: Schiele F, Puymirat E, Bonello L, Meneveau N, Collet JP, Motreff P, Ravan R, Leclercq F, Ennezat PV, Ferrières J, Simon T, Danchin N. Switching between thienopyridines in patients with acute myocardial infarction and quality of care. Open Heart. 2016 May 23;3(1):e000384. doi: 10.1136/openhrt-2015-000384. eCollection 2016.

ReferenceCitation: Aissaoui N, Puymirat E, Juilliere Y, Jourdain P, Blanchard D, Schiele F, Guéret P, Popovic B, Ferrieres J, Simon T, Danchin N. Fifteen-year trends in the management of cardiogenic shock and associated 1-year mortality in elderly patients with acute myocardial infarction: the FAST-MI programme. Eur J Heart Fail. 2016 Sep;18(9):1144-52. doi: 10.1002/ejhf.585.

ReferenceCitation: Puymirat E, Aissaoui N, Lemesle G, Cottin Y, Coste P, Schiele F, Ferrières J, Simon T, Danchin N; FAST-MI Investigators. Long-Term Clinical Outcomes According to Previous Manifestations of Atherosclerotic Disease (from the FAST-MI 2010 Registry). Am J Cardiol. 2017 Mar 1;119(5):692-697. doi: 10.1016/j.amjcard.2016.11.032. Epub 2016 Dec 2.

ReferenceCitation: Puymirat E, Aissaoui N, Cayla G, Lafont A, Riant E, Mennuni M, Saint-Jean O, Blanchard D, Jourdain P, Elbaz M, Henry P, Bataille V, Drouet E, Mulak G, Schiele F, Ferrières J, Simon T, Danchin N; FAST-MI investigators. Changes in One-Year Mortality in Elderly Patients Admitted with Acute Myocardial Infarction in Relation with Early Management. Am J Med. 2017 May;130(5):555-563. doi: 10.1016/j.amjmed.2016.12.005. Epub 2017 Jan 5.

ReferenceCitation: Schiele F, Gale CP, Simon T, Fox KAA, Bueno H, Lettino M, Tubaro M, Puymirat E, Ferrières J, Meneveau N, Danchin N. Assessment of Quality Indicators for Acute Myocardial Infarction in the FAST-MI (French Registry of Acute ST-Elevation or Non-ST-Elevation Myocardial Infarction) Registries. Circ Cardiovasc Qual Outcomes. 2017 Jun;10(6). pii: e003336. doi: 10.1161/CIRCOUTCOMES.116.003336.

ReferenceCitation: Puymirat E, Simon T, Cayla G, Cottin Y, Elbaz M, Coste P, Lemesle G, Motreff P, Popovic B, Khalife K, Labèque JN, Perret T, Le Ray C, Orion L, Jouve B, Blanchard D, Peycher P, Silvain J, Steg PG, Goldstein P, Guéret P, Belle L, Aissaoui N, Ferrières J, Schiele F, Danchin N; USIK, USIC 2000, and FAST-MI investigators. Acute Myocardial Infarction: Changes in Patient Characteristics, Management, and 6-Month Outcomes Over a Period of 20 Years in the FAST-MI Program (French Registry of Acute ST-Elevation or Non-ST-Elevation Myocardial Infarction) 1995 to 2015. Circulation. 2017 Nov 14;136(20):1908-1919. doi: 10.1161/CIRCULATIONAHA.117.030798. Epub 2017 Aug 27.

ReferenceCitation: Bailleul C, Aissaoui N, Cayla G, Dillinger JG, Jouve B, Schiele F, Ferrières J, Simon T, Danchin N, Puymirat E; FAST-MI investigators. Prognostic impact of prepercutaneous coronary intervention TIMI flow in patients with ST-segment and non-ST-segment elevation myocardial infarction: Results from the FAST-MI 2010 registry. Arch Cardiovasc Dis. 2018 Feb;111(2):101-108. doi: 10.1016/j.acvd.2017.04.004. Epub 2017 Sep 19.

ReferenceCitation: Puymirat E, Aissaoui N, Bonello L, Cayla G, Labèque JN, Nallet O, Motreff P, Varenne O, Schiele F, Ferrières J, Simon T, Danchin N; FAST-MI Investigators. Clinical outcomes according to symptom presentation in patients with acute myocardial infarction: Results from the FAST-MI 2010 registry. Clin Cardiol. 2017 Dec;40(12):1256-1263. doi: 10.1002/clc.22819. Epub 2017 Dec 15.

ReferenceCitation: Aissaoui N, Riant E, Lefèvre G, Delmas C, Bonello L, Henry P, Bonnefoy E, Schiele F, Ferrières J, Simon T, Danchin N, Puymirat E; FAST-MI investigators. Long-term clinical outcomes in patients with cardiogenic shock according to left ventricular function: The French registry of Acute ST-elevation and non-ST-elevation Myocardial Infarction (FAST-MI) programme. Arch Cardiovasc Dis. 2018 Nov;111(11):678-685. doi: 10.1016/j.acvd.2017.11.002. Epub 2017 Dec 28.

ReferenceCitation: Isorni MA, Aissaoui N, Angoulvant D, Bonello L, Lemesle G, Delmas C, Henry P, Schiele F, Ferrières J, Simon T, Danchin N, Puymirat É; FAST-MI investigators. Temporal trends in clinical characteristics and management according to sex in patients with cardiogenic shock after acute myocardial infarction: The FAST-MI programme. Arch Cardiovasc Dis. 2018 Oct;111(10):555-563. doi: 10.1016/j.acvd.2018.01.002. Epub 2018 Feb 22.

ReferenceCitation: Puymirat E, Simon T, Danchin N; FAST-MI Investigators. Response by Puymirat et al to Letter Regarding Article, "Acute Myocardial Infarction Changes in Patient Characteristics, Management, and 6-Month Outcomes Over a Period of 20 Years in the FAST-MI Program (French Registry of Acute ST Elevation or Non-ST-Elevation Myocardial Infarction) 1995 to 2015". Circulation. 2018 May 22;137(21):2307-2308. doi: 10.1161/CIRCULATIONAHA.118.033969.

ReferenceCitation: Puymirat E, Cayla G, Cottin Y, Elbaz M, Henry P, Gerbaud E, Lemesle G, Popovic B, Labèque JN, Roubille F, Andrieu S, Farah B, Schiele F, Ferrières J, Simon T, Danchin N. Twenty-year trends in profile, management and outcomes of patients with ST-segment elevation myocardial infarction according to use of reperfusion therapy: Data from the FAST-MI program 1995-2015. Am Heart J. 2019 Aug;214:97-106. doi: 10.1016/j.ahj.2019.05.007. Epub 2019 May 16.

ReferenceCitation: Schiele F, Puymirat E, Ferrières J, Simon T, Fox KAA, Eikelboom J, Danchin N; FAST-MI investigators. The FAST-MI 2005-2010-2015 registries in the light of the COMPASS trial: The COMPASS criteria applied to a post-MI population. Int J Cardiol. 2019 Mar 1;278:7-13. doi: 10.1016/j.ijcard.2018.11.138. Epub 2018 Dec 3.

ReferenceCitation: Tea V, Bonaca M, Chamandi C, Iliou MC, Lhermusier T, Aissaoui N, Cayla G, Angoulvant D, Ferrières J, Schiele F, Simon T, Danchin N, Puymirat E; FAST-MI investigators. Appropriate secondary prevention and clinical outcomes after acute myocardial infarction according to atherothrombotic risk stratification: The FAST-MI 2010 registry. Eur J Prev Cardiol. 2019 Mar;26(4):411-419. doi: 10.1177/2047487318808638. Epub 2018 Oct 24.

ReferenceCitation: Puymirat E, Bonaca M, Iliou MC, Tea V, Ducrocq G, Douard H, Labrunee M, Plastaras P, Chevallereau P, Taldir G, Bataille V, Ferrières J, Schiele F, Simon T, Danchin N; FAST-MI investigators. Outcome associated with prescription of cardiac rehabilitation according to predicted risk after acute myocardial infarction: Insights from the FAST-MI registries. Arch Cardiovasc Dis. 2019 Aug - Sep;112(8-9):459-468. doi: 10.1016/j.acvd.2019.04.002. Epub 2019 May 22.

ReferenceCitation: Puymirat E, Bonaca M, Fumery M, Tea V, Aissaoui N, Lemesles G, Bonello L, Ducrocq G, Cayla G, Ferrières J, Schiele F, Simon T, Danchin N; FAST-MI investigators. Atherothrombotic risk stratification after acute myocardial infarction: The Thrombolysis in Myocardial Infarction Risk Score for Secondary Prevention in the light of the French Registry of Acute ST Elevation or non-ST Elevation Myocardial Infarction registries. Clin Cardiol. 2019 Feb;42(2):227-234. doi: 10.1002/clc.23131. Epub 2018 Dec 27.

ReferenceCitation: Ferrières J, Bataille V, Puymirat E, Schiele F, Simon T, Danchin N; FAST-MI investigators. Applicability of the REDUCE-IT trial to the FAST-MI registry. Are the results of randomized trials relevant in routine clinical practice? Clin Cardiol. 2020 Nov;43(11):1260-1265. doi: 10.1002/clc.23437. Epub 2020 Jul 28.

ReferenceCitation: Garcia R, Marijon E, Karam N, Narayanan K, Anselme F, Cesari O, Champ-Rigot L, Manenti V, Martins R, Puymirat E, Ferrieres J, Schiele F, Simon T, Danchin N. Ventricular fibrillation in acute myocardial infarction: 20-year trends in the FAST-MI study. Eur Heart J. 2022 Oct 28:ehac579. doi: 10.1093/eurheartj/ehac579. Online ahead of print.

ReferenceCitation: Dillinger JG, Achkouty G, Albert F, Muller G, Labèque JN, Moisson L, Morelle JF, Cottin Y, Pezel T, Lim P, Aissaoui N, Schiele F, Ferrières J, Angoulvant D, Henry P, Puymirat E, Simon T, Danchin N; FAST-MI investigators. Deleterious synergistic effects of acute heart failure and diabetes mellitus in patients with acute coronary syndrome: Data from the FAST-MI Registries. Arch Cardiovasc Dis. 2022 May;115(5):264-275. doi: 10.1016/j.acvd.2022.02.004. Epub 2022 Mar 4.

ReferenceCitation: Danchin N, Puymirat E, Cayla G, Cottin Y, Coste P, Gilard M, Goldstein P, Braun F, Belle L, Montalescot G, Ferrières J, Schiele F, Simon T; FAST-MI Investigators. One-Year Survival After ST-Segment-Elevation Myocardial Infarction in Relation With Prehospital Administration of Dual Antiplatelet Therapy. Circ Cardiovasc Interv. 2018 Sep;11(9):e007241. doi: 10.1161/CIRCINTERVENTIONS.118.007241.


title: Evaluation of the Potential of Elastography for Noninvasive Assessment of Fibrosis in Kidney Transplant

acronym: GREFE

summary: The purpose of this study is to assess the potential of elastography for noninvasive assessment of fibrosis in renal allograft.

location_facility: Service de Radiologie, Pavillon P Radio, Hôpital Edouard Herriot


title: Preoxygenation Before Prehospital Tracheal Intubation With NIV Versus Balloon. A Multicenter Randomized Controlled Trial in Mobile Medical Emergency Rescue Service

acronym: PREOXY

summary: Recent studies reports feasibility, effectiveness and even less complications of using NIV for preoxygenation during tracheal intubation in ICU and in Operating Room. None study has been done in emergency out-of-hospital medical rescue. This trial attempts to demonstrate same results or even more in that conditions.

status: Withdrawn

primary_purpose: Supportive Care

ipd_sharing: Undecided

lead_sponsor: Hopital of Melun


title: Method of Assessment of Driving Ability in Patients Suffering From Wakefulness Pathologies. Impact of Lactulose and Carnitine Treatment.

acronym: AutoSop-Foie

summary: The project will improve scientific knowledge regarding a recent law applying potentially to every french driver. It will give for the first time an indication on the impact of alerting treatments on driving risks. It will reinforce the links between different research environments (sleep physiopathology, clinical research, cognitive neurosciences, drivers supervision, virtual reality, pharmacology) among the "Réseau Eveil Sommeil Attention et Transports" (RESAT) network.

primary_purpose: Prevention

lead_sponsor: University Hospital, Caen


title: Study of Bronchoalveolar Lung Remodeling in Subjects From 60 Years Free of Progressive Lung Disease: Structure-function Analysis

summary: The aim of the study is to investigate the relationship between aging and morphological changes in the lung. 120 consecutive healthy volunteers over 60 years will be enrolled for this trial.

ReferenceCitation: Bommart S, Marin G, Bourdin A, Molinari N, Klein F, Hayot M, Vachier I, Chanez P, Mercier J, Vernhet-Kovacsik H. Relationship between CT air trapping criteria and lung function in small airway impairment quantification. BMC Pulm Med. 2014 Feb 28;14:29. doi: 10.1186/1471-2466-14-29.


title: Effects of Treatment of Post-traumatic Stress Disorder on Reduced Recall for Fear Extinction

summary: This preliminary study will examine the differential effects of rTMS on the recall of extinction of conditioned fear in patients suffering from PTSD (post-traumatic stress disorder ) compared with subjects without PTSD but with high risk of relapse.


title: Treatment of Primary Peritoneal Carcinosis of Digestive Origin Using Cytoreductive Surgery and Hyperthermic Intraoperative Peritoneal Chemotherapy With Mitomycin C and Irinotecan

summary: This is an open, non-randomized, phase I-II, pilot study, which evaluates the combination of optimum cytoreductive surgery and hyperthermic intraoperative peritoneal chemotherapy (HIPEC) with mitomycin C (MMC) and irinotecan. The latter drug will be administered in escalating doses to patients with gastric, colorectal, appendicular, or primary peritoneal carcinosis (PC).

location_facility: Service de Chirurgie Générale et Thoracique, Centre Hospitalier Lyon-Sud


title: Multicenter Open and Prospective Trial Assessing the Efficacy of Vitamin D Supplementation in Addition to Pegylated Interferon Plus Ribavirin in Null-Responders Patients With Chronic Viral Hepatitis C Genotype 1 or 4

acronym: ANRS VITAVIC

summary: Vitamin D deficiency is commonly found in patients with chronic hepatitis C. The investigators hypothesize that the correction of hypovitaminosis D before the initiation of anti-HCV combination therapy and the maintenance of an optimal vitamin D status during antiviral therapy could improve the antiviral efficacy

ReferenceCitation: Terrier B, Lapidus N, Pol S, Serfaty L, Ratziu V, Asselah T, Thibault V, Souberbielle JC, Carrat F, Cacoub P. Vitamin D in addition to peg-interferon-alpha/ribavirin in chronic hepatitis C virus infection: ANRS-HC25-VITAVIC study. World J Gastroenterol. 2015 May 14;21(18):5647-53. doi: 10.3748/wjg.v21.i18.5647.

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


acronym: ProphyloCHIP

title: Multicentric Phase III Trial Comparing Simple Follow-up to Exploratory Laparotomy Plus "in Principle" HIPEC (Hyperthermic Intraperitoneal Chemotherapy) in Colorectal Patients Initially Treated With Surgery and Adjuvant Chemotherapy Who Have a High Risk of Developing Colorectal Peritoneal Carcinomatosis

lead_sponsor: Gustave Roussy, Cancer Campus, Grand Paris

ReferenceCitation: Goéré D, Glehen O, Quenet F, Guilloit JM, Bereder JM, Lorimier G, Thibaudeau E, Ghouti L, Pinto A, Tuech JJ, Kianmanesh R, Carretier M, Marchal F, Arvieux C, Brigand C, Meeus P, Rat P, Durand-Fontanier S, Mariani P, Lakkis Z, Loi V, Pirro N, Sabbagh C, Texier M, Elias D; BIG-RENAPE group. Second-look surgery plus hyperthermic intraperitoneal chemotherapy versus surveillance in patients at high risk of developing colorectal peritoneal metastases (PROPHYLOCHIP-PRODIGE 15): a randomised, phase 3 study. Lancet Oncol. 2020 Sep;21(9):1147-1154. doi: 10.1016/S1470-2045(20)30322-3. Epub 2020 Jul 24.

summary: Multicentric randomised trial. Patients with a high risk of developing colorectal Peritoneal Carcinomatosis (PC) after resection of their primary will be informed, will sign the consent and will be pre-registered. All patients will receive the current standard adjuvant treatment : 6 months of systemic chemotherapy (currently the Folfox-4 regimen which could be modified if the standard is modified). Then a work-up is done to exclude recurrence. The likelihood of a recurrence is low but if this occurs, the patient will not be randomised and will be treated with the best known treatment. If the work-up is negative, patients will be randomised to surveillance alone (control group) or exploratory laparotomy + HIPEC (experimental group).


acronym: Interaction tropisétron / Granisétron - paracétamol

title: Comparative Study of the Influence of Two Antagonist Receptors 5-HT3, tropisétron and granisétron, on the Analgesic Effect of Paracétamol

lead_sponsor: University Hospital, Clermont-Ferrand

summary: This is a Crossover study, double-blind, randomized, controlled versus placebo.


title: Study of Efficacy and Tolerance of Early Launching of Nocturnal Non Invasive Ventilation in Adults With Myotonic Dystrophy Type 1(DM1)

acronym: DYVINE

summary: This is a multicenter randomized controlled open labeled study testing efficacy and tolerance of early launching of night non invasive ventilation in patients with myotonic dystrophy type 1(DM1). The object of this project is to estimate the effects of the early introduction of non invasive ventilation on the arisen of complication (non expected hospitalization, tracheostomy even death) with regard to a simple respiratory follow-up in patients affected by myotonic dystrophy.

location_facility: Home ventilation unit and intensive care, centre of neuromuscular disease (Garches Mondor Necker Hendaye), Raymond Poincaré hospital Versailles Saint Quentin University.


title: Epidemiology of Adult Adult Pulmonary Langerhans Cell Histiocytosis - A Multicenter Cohort Study

summary:
Study objectives:

To estimate the incidence of pulmonary deterioration in adult pulmonary Langerhans cell histiocytosis
To assess the impact of tobacco discontinuation
Study Design Multicentric prospective cohort study
Main endpoint: Pulmonary deterioration
Sample size : 40 patients

ReferenceCitation: Tazi A, de Margerie C, Naccache JM, Fry S, Dominique S, Jouneau S, Lorillon G, Bugnet E, Chiron R, Wallaert B, Valeyre D, Chevret S. The natural history of adult pulmonary Langerhans cell histiocytosis: a prospective multicentre study. Orphanet J Rare Dis. 2015 Mar 14;10:30. doi: 10.1186/s13023-015-0249-2.

ReferenceCitation: Tazi A, de Margerie-Mellon C, Vercellino L, Naccache JM, Fry S, Dominique S, Jouneau S, Lorillon G, Bugnet E, Chiron R, Wallaert B, Valeyre D, Chevret S. Extrathoracic investigation in adult patients with isolated pulmonary langerhans cell histiocytosis. Orphanet J Rare Dis. 2016 Feb 2;11:11. doi: 10.1186/s13023-016-0387-1.

intervention_type: Behavioral


title: Behaviour and Cognitive Evaluation for Dialysis Elderly Patients (BCDE)

acronym: BCDE

summary:
The trial is a multicenter, prospective, randomized, open study. A total of 500 elderly patients aged over 75 years with renal insufficiency stage 5 will be included in the study after signed informed consent. Patients will be randomized 1/1 in two arms : 250 patients in the "exclusive nephrology follow-up" arm will continue their usual follow-up; 250 patients in the "geriatric follow-up" arm will have both their usual nephrology follow-up and a geriatric follow-up.

The aim of the study is to determine if a systematized gerontologist evaluation delay the occurrence of a composite primary endpoint : death, dementia, depression and severe dependency. The hypothesis is that the functional and vital prognosis of a patient with renal insufficiency depends not only on common and classical factors but also on cognitive and psychological functions and dependence, particularly in elderly patients.


title: Mobilization by Plerixafor of Haematopoietic Stem Cells in Children

summary: This is a prospective Phase II, monocentre study.


title: Saliva and Plasma Endocannabinoids Concentrations According to Feeding Status and Body Mass Index

acronym: SALIVENDO

summary: Up till now, the evaluation of the endocannabinoid system (ECS) in humans needs invasive procedures. The investigators managed in the lab to determine the levels of endocannabinoids in a small number of subjects. The aim of the study is to confirm that salivary is a useful tool to evaluate the activity of the ECS both in normal weight and obese subjects that are characterised by a hyperactivity of the system. Therefore, the first objective of the study is to compare the fasting level of salivary anandamide between 12 obese patients and 12 normal weight subjects.

lead_sponsor: University Hospital, Bordeaux

location_facility: Service of Endocrinology, Diabetology, metabolic diseases - Hôpital du Haut Lévêque - CHU de BORDEAUX

intervention_type: Biological


title: TREATMENT OF THE RECESSIVE NONBULLOUS CONGENITAL ICHTHYOSIS BY THE EPIGALLOCATECHINE CUTANEOUS

summary:
Lamellar ichthyosis (IL) is a rare autosomal recessive genodermatosis with a defect of keratinization of the skin which results in a severe generalized cutaneous xerosis with dark brown big scales, an ectropion, an eclabion, an alopecia and a palmo-plantar keratodermia. They are due to mutations of the gene TGM1 coding for the transglutaminase keratinocyte 1 (TG1) in 1/3 of the cases. Other genes were recently identified, ABCA12 coding for the triphosphate-binding adenosine cassette A12 and FLJ39501 which codes for a protein of the cytochrome p450 ( CYP4F2).

No etiological treatment is available. Symptomatic treatment consists on twice application of emollients and keratolytic ointments which decrease the dryness of the skin and reduce scales. Oral isotretinoin is usually partially effective but is only suspensive and has numerous side effects.

Recent studies showed that the epigallocatechin-3-gallate (POLYPHENON E®), extracted from green tea increases the differentiation of the normal human keratinocytes, as showedb by the increase of the involucrine, TG1 and caspase-14 genes expression.

The main objective of this pilot study is to estimate the action and the tolerance of a daily application of topical Polyphénon E 10% ® to improve the desquamation and the cutaneous roughness of patients with lamellar ichthyosis, after 4 weeks of treatment.

The secondary objectives

To estimate the duration of remission obtained after the treatment
To estimate the action of cutaneous Veregen® to improve the palmar and plantar involvement.
To estimate the action of cutaneous Veregen on the pruritus
And to estimate the global level of acceptability by the patient of the Veregen 10 %

location_facility: Toulouse University Hospital, Dermatology Department


title: Pilot Study of the Action L-lysine on Aldosterone and Cortisol Secretion in Healthy Volunteers.

acronym: L-Lysine

summary: Data from the literature and previous in vitro research conducted in the investigators' laboratory (INSERM U413/EA4310, University of Rouen) suggest that adrenal corticosteroid secretion might be controlled by a paracrine mechanism involving serotonin type IV receptor (5-HT 4). L-lysine, a common amino-acid has been shown to act as a 5-HT4 agonist in vitro as well as in vivo. In the present physiology trial, plasma aldosterone and cortisol levels will be measured under treatment with aprepitant versus placebo, in both basal conditions and after activation of the adrenocortical function by various stimuli, including upright posture, metoclopramide, and after a 3 days salt-free diet. All healthy volunteers will be given two substances (L-lysine and placebo) in a random order during two 13 days periods separated by a 14 day-wash-out. This study should allow to determine the role of 5-HT4 receptors in the control of corticosteroid production in normal man.

lead_sponsor: University Hospital, Rouen

location_facility: Rouen Clinical research Centre (CIC 0204)

intervention_type: Dietary Supplement


title: Evaluation of the Predictive Ability of Urinary NGAL as an Early Marker of Acute Kidney Injury Following Cardiac Surgery in Neonates and Infants

acronym: NGAL

summary:
Urinary NGAL has been shown to be an early marker of acute kidney injury (AKI) following paediatric cardiac surgery (2 hours off pump). Previous studies showed that an early increase of urinary NGAL following cardiopulmonary bypass was predictive of AKI. Several studies included heterogeneous populations of children undergoing cardiac surgery, but NGAL has not been studied in neonates after open heart surgery, neither has been identified the threshold for accurate prediction of severe AKI requiring renal replacement therapy.

The aim of this observational cohort study is to describe postoperative kinetics of urinary NGAL in neonates and to identify the threshold for accurate prediction of severe AKI requiring renal replacement therapy in neonates and infants undergoing cardiac surgery

ReferenceCitation: Bennett M, Dent CL, Ma Q, Dastrala S, Grenier F, Workman R, Syed H, Ali S, Barasch J, Devarajan P. Urine NGAL predicts severity of acute kidney injury after cardiac surgery: a prospective study. Clin J Am Soc Nephrol. 2008 May;3(3):665-73. doi: 10.2215/CJN.04010907. Epub 2008 Mar 12.

ReferenceCitation: Mishra J, Dent C, Tarabishi R, Mitsnefes MM, Ma Q, Kelly C, Ruff SM, Zahedi K, Shao M, Bean J, Mori K, Barasch J, Devarajan P. Neutrophil gelatinase-associated lipocalin (NGAL) as a biomarker for acute renal injury after cardiac surgery. Lancet. 2005 Apr 2-8;365(9466):1231-8.

ReferenceCitation: Haase M, Bellomo R, Devarajan P, Schlattmann P, Haase-Fielitz A; NGAL Meta-analysis Investigator Group. Accuracy of neutrophil gelatinase-associated lipocalin (NGAL) in diagnosis and prognosis in acute kidney injury: a systematic review and meta-analysis. Am J Kidney Dis. 2009 Dec;54(6):1012-24. doi: 10.1053/j.ajkd.2009.07.020. Epub 2009 Oct 21. Review.

ReferenceCitation: Bojan M, Basto Duarte MC, Lopez V, Tourneur L, Vicca S, Froissart M. Low perfusion pressure is associated with renal tubular injury in infants undergoing cardiac surgery with cardiopulmonary bypass: A secondary analysis of an observational study. Eur J Anaesthesiol. 2018 Aug;35(8):581-587. doi: 10.1097/EJA.0000000000000782.

ReferenceCitation: Bojan M, Basto Duarte MC, Ermak N, Lopez-Lopez V, Mogenet A, Froissart M. Structural equation modelling exploration of the key pathophysiological processes involved in cardiac surgery-related acute kidney injury in infants. Crit Care. 2016 Jun 5;20(1):171. doi: 10.1186/s13054-016-1350-1.

ReferenceCitation: Bojan M, Vicca S, Lopez-Lopez V, Mogenet A, Pouard P, Falissard B, Journois D. Predictive performance of urine neutrophil gelatinase-associated lipocalin for dialysis requirement and death following cardiac surgery in neonates and infants. Clin J Am Soc Nephrol. 2014 Feb;9(2):285-94. doi: 10.2215/CJN.04730513. Epub 2013 Nov 21.


title: Benefits Study of a Respiratory Gating Protocol for 18F-FDG PET: Application on the Liver

acronym: RespiTEP

summary:
Fluorodeoxyglucose (FDG) positron emission tomography (PET) is now widely used for cancer imaging purpose, notably for preoperative work-up. It aims at visualizing organs metabolism. In case of cancer, metabolism is, classically, increased and some hot spots are visible on PET images. Because of respiratory motion and because the liver is intrinsically FDG avid, some tumours (especially the smallest ones) can be occulted and missed by the clinician.

The investigators developed a respiratory-gated PET method in order to reduce the motion issue. This protocol has been validated on lung pathologies. The investigators designed a study to investigate its effect on liver cancer (primary or metastasis) to check if it allows the detection of a higher number of tumour lesions.

To that aim, patients who are planned to undergo a surgical intervention on the liver can be proposed to participate this study. After the standard PET acquisition (acquired in free-breathing), an additional 10 minutes respiratory-gated PET acquisition is performed without additional injection. After that, a breath-hold (~10s) CT is performed.

ReferenceCitation: Fin L, Daouk J, Bailly P, Slama J, Morvan J, El Esper I, Régimbeau JM, Chatelain D, Diouf M, Meyer ME. Improved imaging of intrahepatic colorectal metastases with 18F-fluorodeoxyglucose respiratory-gated positron emission tomography. Nucl Med Commun. 2012 Jun;33(6):656-62. doi: 10.1097/MNM.0b013e328351fce8.

ReferenceCitation: Daouk J, Fin L, Bailly P, Slama J, Diouf M, Morvan J, El Esper I, Regimbeau J-M, Chatelain D, Meyer M-E. The Benefits of Respiratory Gating in 18F-FDG PET Imaging of the Liver, The International Journal of Nuclear Energy Science and Engineering 2(1):5-10, 2012

lead_sponsor: Centre Hospitalier Universitaire, Amiens

location_facility: centre hospitalier universitaire d'Amiens


title: Prospective Cohort Study of Late Pulmonary Complications in Patients Who Received Allogeneic Hematopoietic Stem Cells Transplantation: Estimation of Incidence and Identification of Distinct Nosologic Entities

acronym: ALLOPULM

summary: This is a prognostic study of the late lung complications arising at the patient's having received an allograft of hematopoetic stem cells.

ReferenceCitation: Bergeron A, Chevret S, Peffault de Latour R, Chagnon K, de Margerie-Mellon C, Rivière F, Robin M, Mani J, Lorillon G, Socié G, Tazi A. Noninfectious lung complications after allogeneic haematopoietic stem cell transplantation. Eur Respir J. 2018 May 3;51(5). pii: 1702617. doi: 10.1183/13993003.02617-2017. Print 2018 May.