title: Early Surgery for Patients With Asymptomatic Aortic Stenosis

acronym: ESTIMATE

summary: Many cardiologists are convinced that early surgery in asymptomatic aortic stenosis (AS) saves lives. However there is currently no direct evidence for this and most recommendations from the ESC/ EACTS or ACC/ AHA in this field are supported by Level-B or C evidence. Therefore, the investigators designed a randomized controlled trial to demonstrate whether early surgery improves mortality and morbidity of patients with asymptomatic severe AS and low operative risk.

ReferenceCitation: Monin JL, Lancellotti P, Monchi M, Lim P, Weiss E, Piérard L, Guéret P. Risk score for predicting outcome in patients with asymptomatic aortic stenosis. Circulation. 2009 Jul 7;120(1):69-75. doi: 10.1161/CIRCULATIONAHA.108.808857. Epub 2009 Jun 22.

ReferenceCitation: Farré N, Gómez M, Molina L, Cladellas M, Blé M, Roqueta C, Ascoeta MS, Comin-Colet J, Vila J, Bruguera J. Prognostic value of NT-proBNP and an adapted monin score in patients with asymptomatic aortic stenosis. Rev Esp Cardiol (Engl Ed). 2014 Jan;67(1):52-7. doi: 10.1016/j.rec.2013.06.020. Epub 2013 Oct 20.

ReferenceCitation: Nishimura RA, Otto CM, Bonow RO, Carabello BA, Erwin JP 3rd, Guyton RA, O'Gara PT, Ruiz CE, Skubas NJ, Sorajja P, Sundt TM 3rd, Thomas JD; American College of Cardiology/American Heart Association Task Force on Practice Guidelines. 2014 AHA/ACC guideline for the management of patients with valvular heart disease: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines. J Am Coll Cardiol. 2014 Jun 10;63(22):e57-185. doi: 10.1016/j.jacc.2014.02.536. Epub 2014 Mar 3. Erratum in: J Am Coll Cardiol. 2014 Jun 10;63(22):2489. Dosage error in article text.

ReferenceCitation: Joint Task Force on the Management of Valvular Heart Disease of the European Society of Cardiology (ESC); European Association for Cardio-Thoracic Surgery (EACTS), Vahanian A, Alfieri O, Andreotti F, Antunes MJ, Barón-Esquivias G, Baumgartner H, Borger MA, Carrel TP, De Bonis M, Evangelista A, Falk V, Iung B, Lancellotti P, Pierard L, Price S, Schäfers HJ, Schuler G, Stepinska J, Swedberg K, Takkenberg J, Von Oppell UO, Windecker S, Zamorano JL, Zembala M. Guidelines on the management of valvular heart disease (version 2012). Eur Heart J. 2012 Oct;33(19):2451-96. doi: 10.1093/eurheartj/ehs109. Epub 2012 Aug 24.

ReferenceCitation: Otto CM, Lind BK, Kitzman DW, Gersh BJ, Siscovick DS. Association of aortic-valve sclerosis with cardiovascular mortality and morbidity in the elderly. N Engl J Med. 1999 Jul 15;341(3):142-7.


type: Other Identifier

title: MRI Study of Ballooning and Ligamentisation Short Transplants ACL Hamstring According to Technical DT4

summary: MRI study of ballooning and ligamentisation short transplants of anterior cruciate ligament (ACL) according to DT4 technique in 60 patients with more than one year of follow up.

study_start_date_type: Actual

status: Unknown status

study_completion_date_type: Anticipated

study_type: Observational

time_perspective: Prospective

enrollment_type: Anticipated

ipd_sharing: No

lead_sponsor: University Hospital, Lille

lead_sponsor_type: academique

status_simplified: Unknown


type: Registry Identifier

title: ADIposity and Bone Metabolism: Effects of eXercise-induced Weight Loss in Obese Adolescents

acronym: ADIBOX

summary:
The present protocol is mainly involved in the understanding of the local interaction between the released products by fat tissue and hormones production of bone tissue. These complex interactions between adipocyte and osteocyte activities could explain the mechanisms of the body responses to the strategies of weight loss that include diet and/or physical activity program, as well as the side effects encountered by these interventions.

Adolescence is a period of development characterized by many metabolic and somatic changes that may influence weight. Weights bearing physical activities are a key factor allowing body composition changes (i.e. fat and bone tissue). The difficulties of managing weight and the onset of overweight and obesity during this very important growth spurt lead to various hormonal dysregulation. The specific mechanisms of the evolution and interactions between these two parameters (fat and bone tissue) are not yet elucidated; therefore our aim is to analyze the possible connections between fat tissue and the quality of the skeleton in order to reduce related risks of the consequence of weight loss in obese individuals.

study_type: Interventional

design_allocation: Non-Randomized

ReferenceType: derived

ReferenceCitation: Chaplais E, Dutheil F, Naughton G, Greene D, Pereira B, Thivel D, Courteix D. Cross-sectional and longitudinal study protocols of the 'ADIposity and BOne metabolism: effects of eXercise-induced weight loss in obese adolescents' (ADIBOX) project. BMJ Open. 2016 Oct 18;6(10):e011407. doi: 10.1136/bmjopen-2016-011407.

lead_sponsor: University Hospital, Clermont-Ferrand

intervention_type: Radiation


title: Perfusion Evaluation by Real-time Fluorescence-based Enhanced Reality of Anastomosis

acronym: PERFECT

summary: The aim of this study is to evaluate the ability of a ICG-fluorescence guidance complemented with enhanced reality to correctly document intestinal pre-anastomotic perfusion and to validate the accuracy of this technique with metabolic intestinal cells changes.

status: Completed

study_completion_date_type: Actual

primary_purpose: Prevention

enrollment_type: Actual

ReferenceType: background

ReferenceCitation: Diana M, Noll E, Diemunsch P, Dallemagne B, Benahmed MA, Agnus V, Soler L, Barry B, Namer IJ, Demartines N, Charles AL, Geny B, Marescaux J. Enhanced-reality video fluorescence: a real-time assessment of intestinal viability. Ann Surg. 2014 Apr;259(4):700-7. doi: 10.1097/SLA.0b013e31828d4ab3.

ReferenceCitation: Diana M, Halvax P, Dallemagne B, Nagao Y, Diemunsch P, Charles AL, Agnus V, Soler L, Demartines N, Lindner V, Geny B, Marescaux J. Real-time navigation by fluorescence-based enhanced reality for precise estimation of future anastomotic site in digestive surgery. Surg Endosc. 2014 Nov;28(11):3108-18. doi: 10.1007/s00464-014-3592-9. Epub 2014 Jun 10.

ReferenceCitation: Diana M, Dallemagne B, Chung H, Nagao Y, Halvax P, Agnus V, Soler L, Lindner V, Demartines N, Diemunsch P, Geny B, Swanström L, Marescaux J. Probe-based confocal laser endomicroscopy and fluorescence-based enhanced reality for real-time assessment of intestinal microcirculation in a porcine model of sigmoid ischemia. Surg Endosc. 2014 Nov;28(11):3224-33. doi: 10.1007/s00464-014-3595-6. Epub 2014 Jun 17.

ReferenceCitation: Diana M, Agnus V, Halvax P, Liu YY, Dallemagne B, Schlagowski AI, Geny B, Diemunsch P, Lindner V, Marescaux J. Intraoperative fluorescence-based enhanced reality laparoscopic real-time imaging to assess bowel perfusion at the anastomotic site in an experimental model. Br J Surg. 2015 Jan;102(2):e169-76. doi: 10.1002/bjs.9725.

ReferenceCitation: Boni L, David G, Mangano A, Dionigi G, Rausei S, Spampatti S, Cassinotti E, Fingerhut A. Clinical applications of indocyanine green (ICG) enhanced fluorescence in laparoscopic surgery. Surg Endosc. 2015 Jul;29(7):2046-55. doi: 10.1007/s00464-014-3895-x. Epub 2014 Oct 11.

ReferenceCitation: D'Urso A, Agnus V, Barberio M, Seeliger B, Marchegiani F, Charles AL, Geny B, Marescaux J, Mutter D, Diana M. Computer-assisted quantification and visualization of bowel perfusion using fluorescence-based enhanced reality in left-sided colonic resections. Surg Endosc. 2021 Aug;35(8):4321-4331. doi: 10.1007/s00464-020-07922-9. Epub 2020 Aug 27.

lead_sponsor: IHU Strasbourg

location_facility: Service de Chirurgie Digestive et Endocrinienne - Nouvel Hôpital Civil

intervention_type: Procedure

status_simplified: Completed


title: Immune Modulation Study in Patients With Metastatic Melanoma Treated With Anti-PD1 Monoclonal Antibodies

acronym: PAIR

summary: This is an open mono-centric prospective non-randomized study in patients with metastatic melanoma treated with Anti-PD1 monoclonal antibodies (Nivolumab). The aim of the study is to identify the immune cells modulations differences between patients who present a complete, partial or stable response and patients who have non-response to the therapy in order to establish an improving response rate strategy.

primary_purpose: Other

lead_sponsor: Hospices Civils de Lyon

intervention_type: Biological


title: ELENA Cohort: A Long-term Longitudinal Study in a Pediatric Sample With Autism Spectrum Disorders

acronym: ELENA

summary:
The objective of the ELENA French Cohort is to study the developmental trajectories of children and adolescents with ASD and their risk or protective associated factors.

This is an open, prospective and multicenter cohort study, including children and adolescents under 16 years of age with ASD recruited from services specialized in the assessment of developmental disorders.

status: Active, not recruiting

ReferenceCitation: Vernhet C, Michelon C, Dellapiazza F, Rattaz C, Geoffray MM, Roeyers H, Picot MC, Baghdadli A; ELENA study group. Perceptions of parents of the impact of autism spectrum disorder on their quality of life and correlates: comparison between mothers and fathers. Qual Life Res. 2022 May;31(5):1499-1508. doi: 10.1007/s11136-021-03045-3. Epub 2021 Nov 25.

ReferenceCitation: Miniarikova E, Vernhet C, Peries M, Loubersac J, Picot MC, Munir K, Baghdadli A. Anxiety and depression in parents of children with autism spectrum disorder during the first COVID-19 lockdown: Report from the ELENA cohort. J Psychiatr Res. 2022 May;149:344-351. doi: 10.1016/j.jpsychires.2021.11.022. Epub 2021 Nov 8.

ReferenceCitation: Berard M, Rattaz C, Peries M, Loubersac J, Munir K, Baghdadli A. Impact of containment and mitigation measures on children and youth with ASD during the COVID-19 pandemic: Report from the ELENA cohort. J Psychiatr Res. 2021 May;137:73-80. doi: 10.1016/j.jpsychires.2021.02.041. Epub 2021 Feb 22.

ReferenceCitation: Baghdadli A, Miot S, Rattaz C, Akbaraly T, Geoffray MM, Michelon C, Loubersac J, Traver S, Mortamais M, Sonié S, Pottelette J, Robel L, Speranza M, Vesperini S, Maffre T, Falissard B, Picot MC; ELENA Study Group. Investigating the natural history and prognostic factors of ASD in children: the multicEntric Longitudinal study of childrEN with ASD - the ELENA study protocol. BMJ Open. 2019 Jun 19;9(6):e026286. doi: 10.1136/bmjopen-2018-026286.

lead_sponsor: University Hospital, Montpellier

status_simplified: Ongoing


title: Impact of Antibiotic Treatment of Group A Streptococcal Blistering Distal Dactylitis in Children

acronym: TAPPS

summary: Single-center prospective study to assess the clinical course of group A streptococcal blistering distal dactylitis in children after antibiotic treatment.

primary_purpose: Diagnostic

lead_sponsor: Camille JUNG

lead_sponsor_type: industriel


title: Long Term Effects of Positive Airway Pressure Therapies on Vascular Function in Obstructive Sleep Apnea

summary:
Obstructive sleep apnea syndrome is responsible of endothelial dysfunction, which is a independent cardio-vascular risk factor.

Assessment of pulse wave velocity (PWV) and peripheral arterial tone (PAT) are study measurements of arterial stiffness, and are strong predictors of late cardiovascular events.

This study will compare long term evolution in arterial stiffness (PWV) and endothelial dysfunction (PAT) for patients treated by Positive Airway Pressure Therapies.

lead_sponsor: University Hospital, Grenoble

intervention_type: Other


title: Randomized Phase II Trial Evaluating the Efficiency of Pasireotide for the Treatment of Gastrointestinal Angiodysplasia in Endoscopic Treatment Failure

acronym: ANGIOPAS

summary:
The angiodysplasias may be responsible for recurrent gastrointestinal bleeding and in some cases bleeding remaining inaccessible to endoscopic treatment. Several observational studies suggest that treatment with somatostatin analogue would reduce transfusion requirements in patients with recurrent bleeding due to angiodysplasia.

No randomized studies are available. The main objective of this study multicenter, prospective, randomized, was to assess the transfusion requirements in patients with recurrent bleeding due to angiodysplasia treated by a new analogue of somatostatin, Pasireotide, versus placebo.

Patients with recurrent gastrointestinal bleeding related to angiodysplasias, endoscopic treatment failure, with a need transfusion at least 6 red blood cells during the 6 months prior to inclusion could be randomized to receive monthly intramuscular injection of Pasireotide 60 mg or placebo for a period of 6 months. Patients were then followed for an additional 6 months after stopping treatment. A test monthly clinical and laboratory was performed during the six months of treatment then quarterly during the six months of surveillance.

design_allocation: Randomized

primary_purpose: Treatment

ReferenceCitation: Boley SJ, Sammartano R, Adams A, DiBiase A, Kleinhaus S, Sprayregen S. On the nature and etiology of vascular ectasias of the colon. Degenerative lesions of aging. Gastroenterology. 1977 Apr;72(4 Pt 1):650-60.

ReferenceCitation: Foutch PG, Rex DK, Lieberman DA. Prevalence and natural history of colonic angiodysplasia among healthy asymptomatic people. Am J Gastroenterol. 1995 Apr;90(4):564-7.

ReferenceCitation: Vreeburg EM, Snel P, de Bruijne JW, Bartelsman JF, Rauws EA, Tytgat GN. Acute upper gastrointestinal bleeding in the Amsterdam area: incidence, diagnosis, and clinical outcome. Am J Gastroenterol. 1997 Feb;92(2):236-43.

ReferenceCitation: Ohmiya N, Yano T, Yamamoto H, Arakawa D, Nakamura M, Honda W, Itoh A, Hirooka Y, Niwa Y, Maeda O, Ando T, Yao T, Matsui T, Iida M, Tanaka S, Chiba T, Sakamoto C, Sugano K, Goto H. Diagnosis and treatment of obscure GI bleeding at double balloon endoscopy. Gastrointest Endosc. 2007 Sep;66(3 Suppl):S72-7.

ReferenceCitation: Chalasani N, Cotsonis G, Wilcox CM. Upper gastrointestinal bleeding in patients with chronic renal failure: role of vascular ectasia. Am J Gastroenterol. 1996 Nov;91(11):2329-32.

ReferenceCitation: Bhutani MS, Gupta SC, Markert RJ, Barde CJ, Donese R, Gopalswamy N. A prospective controlled evaluation of endoscopic detection of angiodysplasia and its association with aortic valve disease. Gastrointest Endosc. 1995 Nov;42(5):398-402.

ReferenceCitation: Veyradier A, Balian A, Wolf M, Giraud V, Montembault S, Obert B, Dagher I, Chaput JC, Meyer D, Naveau S. Abnormal von Willebrand factor in bleeding angiodysplasias of the digestive tract. Gastroenterology. 2001 Feb;120(2):346-53.

ReferenceCitation: Pavey DA, Craig PI. Endoscopic therapy for upper-GI vascular ectasias. Gastrointest Endosc. 2004 Feb;59(2):233-8.

ReferenceCitation: Junquera F, Feu F, Papo M, Videla S, Armengol JR, Bordas JM, Saperas E, Piqué JM, Malagelada JR. A multicenter, randomized, clinical trial of hormonal therapy in the prevention of rebleeding from gastrointestinal angiodysplasia. Gastroenterology. 2001 Nov;121(5):1073-9.

ReferenceCitation: Bauditz J, Lochs H, Voderholzer W. Macroscopic appearance of intestinal angiodysplasias under antiangiogenic treatment with thalidomide. Endoscopy. 2006 Oct;38(10):1036-9.

ReferenceCitation: Dabak V, Kuriakose P, Kamboj G, Shurafa M. A pilot study of thalidomide in recurrent GI bleeding due to angiodysplasias. Dig Dis Sci. 2008 Jun;53(6):1632-5.

ReferenceCitation: Kurosaki M, Saegert W, Abe T, Lüdecke DK. Expression of vascular endothelial growth factor in growth hormone-secreting pituitary adenomas: special reference to the octreotide treatment. Neurol Res. 2008 Jun;30(5):518-22.

ReferenceCitation: Ludwig D, Terai S, Brüning A, Stange EF. Long-term haemodynamic effects of octreotide on postprandial splanchnic hyperemia in humans: a placebo-controlled echo-doppler study. Aliment Pharmacol Ther. 1999 Aug;13(8):1119-29.

ReferenceCitation: Szilagyi A, Ghali MP. Pharmacological therapy of vascular malformations of the gastrointestinal tract. Can J Gastroenterol. 2006 Mar;20(3):171-8. Review.

ReferenceCitation: Nardone G, Rocco A, Balzano T, Budillon G. The efficacy of octreotide therapy in chronic bleeding due to vascular abnormalities of the gastrointestinal tract. Aliment Pharmacol Ther. 1999 Nov;13(11):1429-36.

ReferenceCitation: Scaglione G, Pietrini L, Russo F, Franco MR, Sorrentini I. Long-acting octreotide as rescue therapy in chronic bleeding from gastrointestinal angiodysplasia. Aliment Pharmacol Ther. 2007 Sep 15;26(6):935-42.

ReferenceCitation: Brown C, Subramanian V, Wilcox CM, Peter S. Somatostatin analogues in the treatment of recurrent bleeding from gastrointestinal vascular malformations: an overview and systematic review of prospective observational studies. Dig Dis Sci. 2010 Aug;55(8):2129-34. doi: 10.1007/s10620-010-1193-6. Review.

ReferenceCitation: Weckbecker G, Briner U, Lewis I, Bruns C. SOM230: a new somatostatin peptidomimetic with potent inhibitory effects on the growth hormone/insulin-like growth factor-I axis in rats, primates, and dogs. Endocrinology. 2002 Oct;143(10):4123-30.

lead_sponsor: Robert Benamouzig

location_facility: Société Française d'Endoscopie Digestive (SFED)

intervention_type: Drug


title: Innovative Treatment for Scarred Vocal Cords by Local Injection of Autologous Stromal Vascular Fraction

summary: Post-operative scarring on vocal cords is responsible for disorders of the vibration of the lining to the original dysphonia can be troublesome for the patient both in his private and professional life. There is no currently codified treatment for this type of situation and no therapeutic antifibrotic has been effective. Cell therapy is a promising new approach.After a liposuction and removing of mature adipocytes (40 to 60%), the remaining cells called stromal vascular fraction (SVF) could be isolated. SVF consists of a heterogeneous cell population including multipotent stem cells similar to mesenchymal stem cells present in bone marrow. The investigators hypothesis is that the trophic and antifibrotic properties of SVF could benefit patients with vocal cords scarring responsible for dysphonia.

ReferenceCitation: Mattei A, Bertrand B, Jouve E, Blaise T, Philandrianos C, Grimaud F, Giraudo L, Aboudou H, Dumoulin C, Arnaud L, Revis J, Galant C, Velier M, Veran J, Dignat-George F, Dessi P, Sabatier F, Magalon J, Giovanni A. Feasibility of First Injection of Autologous Adipose Tissue-Derived Stromal Vascular Fraction in Human Scarred Vocal Folds: A Nonrandomized Controlled Trial. JAMA Otolaryngol Head Neck Surg. 2020 Apr 1;146(4):355-363. doi: 10.1001/jamaoto.2019.4328.

lead_sponsor: Assistance Publique Hopitaux De Marseille

location_facility: Assisitance Publique Hopitaux de Marseille


title: Course and Follow up of Patients Affected by Facioscapulohumeral Dystrophy

acronym: FSHD

summary: On the basis of published data and our results indicating that oxidative stress may contribute to the peripheral skeletal muscle dysfunction in patients with FSHD, investigators conducted a pilot randomized double-blind placebo controlled trial to test whether oral administration of vitamins and mineral could improve the physical performance of patients with FSHD.The result of this clinical trial showed that antioxidants supplementation may improve skeletal muscle function of patients with FSHD and suggest that an antioxidant strategy adapted may be a relevant therapeutic approach for these patients. Since then, patients with FSHD who attend consultation at Montpellier hospital are systematically supplemented with antioxidants according their own blood tests.

status: Recruiting

primary_purpose: Supportive Care

location_facility: Montpellier University Hospital- Saint Eloi Hospital


title: Study of the Impact of Osteopathic Care, Complementary Therapy to Standard Care, on Pain in Patients With Breast Cancer Surgery

acronym: IPOD

summary:
Breast cancer can be painful following surgery or can develop later and remain persistent. Pain occurrence is frequent with 50% of women developing sequelae pain of varying intensity with an impact on the quality of life. One of the priorities of the 3rd French Cancer Plan is to preserve quality of life.

Osteopathy, complementary therapy, may help to reduce inconvenience caused by the disease, treatments and their side effects (asthenia, anxiety and pain).

The main objective is to assess the impact of osteopathic treatment on pain in patients following breast cancer surgery. The impact will be considered beneficial if the pain score (digital scale) in the intervention group is lower, by at least two points, than the pain score in the control group at the end of the study.

This is a monocentric, randomized, parallel group, single-blind and prospective clinical trial.


title: Non-Invasive Evaluation of Myocardial Stiffness by Elastography Pediatric Cardiology Under

summary:
First, investigators must determine the physiological standards across age classes of myocardial stiffness estimated by Elastography in ultrafast (estimated right ventricular stiffness [VD] and left ventricular [LV]). This will be done in groups of children without heart condition, age group (10 children per group, four age groups [0-1mois, 1 month-1 year 1 year-5 years, 5 years-15years]).

Secondly, investigators will evaluate myocardial stiffness Elastography (RV and LV) on different groups of children (same age group) with cardiomyopathy and examine correlations with the conventional parameters of systolic and diastolic function of both ventricles and with myocardial strain values. The total population of the study will be 120 children (40 healthy, 80 patients).

lead_sponsor: French Cardiology Society

intervention_type: Device


title: Multicenter Study of Risk-adapted Treatment for T-lineage ALL of Young Adults (18-59 Years Old): Evaluating the Efficacy of a Nelarabine Based Consolidation and Maintenance in High-risk Patients

summary: The purpose of this study is to evaluate the efficacy of nelarabine-based consolidation and maintenance therapy in term of relapse-free survival (RFS) in high-risk (HR) patients.

lead_sponsor: Assistance Publique - Hôpitaux de Paris


title: ChEmo-Genomics Based Treatment of Acute Myeloid Leukemia- CeGAL-IPC 2014-012

acronym: CeGAL

summary: Adult acute myeloid leukemia (AML) is a heterogeneous hematologic malignancy associated with poor prognosis, especially after relapse. High-throughput genomic studies have highlighted the importance of molecular alteration in the pathophysiology, clinical evolution and treatment response of AML. In addition, identification of specific gene mutation can be targeted by specific inhibitors, opening the way to personalized treatments. However, only a limited number of gene mutations are druggable or actionable, highlighting the need for additional information to guide treatment choices. Among them, new Drug Screening Tests (DST) allow for the screening of library of hundreds of drugs to ex-vivo patient-derived AML cells. Combination of genomic and pharmacologic approaches might therefore improve prediction of drug effects. There is an urgent need to bring these approaches into the clinic but feasibility trials are necessary before incorporating them into treatments strategies.The proposed study is a prospective multicentre feasibility study of a combined "chemo-genomic" approach in patients with advanced AML.

ReferenceCitation: Collignon A, Hospital MA, Montersino C, Courtier F, Charbonnier A, Saillard C, D'Incan E, Mohty B, Guille A, Adelaide J, Carbuccia N, Garnier S, Mozziconacci MJ, Zemmour C, Pakradouni J, Restouin A, Castellano R, Chaffanet M, Birnbaum D, Collette Y, Vey N. A chemogenomic approach to identify personalized therapy for patients with relapse or refractory acute myeloid leukemia: results of a prospective feasibility study. Blood Cancer J. 2020 Jun 3;10(6):64. doi: 10.1038/s41408-020-0330-5.

lead_sponsor: Institut Paoli-Calmettes


title: Evaluation of the Impact of a Follow-up Phone Call Nurse Device in the Care of Patients With Chemotherapy Treatment, in Their Quality of Life and Medico-economic Analysis of This Follow-up Program Device

acronym: EVAL'COACH

summary: This study evaluate the Impact of a Follow-up Phone Call Nurse Device in the Care of Patients With Chemotherapy Treatment, in their Quality of Life and Medico-economic Analysis of this Follow-up Program Device.

primary_purpose: Health Services Research

lead_sponsor: Institut Claudius Regaud


type: EudraCT Number

title: Effects of the Bilateral Mandibular Nerve Block (V3) in Mandibular Osteotomy: a Prospective, Randomized, Double-blind Versus Placebo Study

summary: The sensory innervation of the face depends on the trigeminal (fifth cranial) which is divided into three branches, the mandibular nerve (V3) having motor fibers to the temporal and masseter muscle. The regional anesthesia of the face has grown in recent years for performing certain actions under light general anesthesia or sedation. The mandibular block is a simple and reliable technique but little used. Yet it reduces postoperative pain sagittal osteotomy of the mandibular branch by reducing consumption of opioids and in the oropharynx cancer surgery. Made with ropivacaine, known for its vasoconstrictive action, it also improves the visibility of the operative field during mandibular osteotomies reducing bleeding. Despite a real clinical benefit (ease of implementation, latency and duration of action of the local anesthetic), the V3 block ropivacaine is not evaluated in the maxillofacial surgery.

ReferenceCitation: Bertuit M, Rapido F, Ly H, Vannucci C, Ridolfo J, Molinari N, De Boutray M, Galmiche S, Dadure C, Perrigault PF, Capdevila X, Chanques G. Bilateral mandibular block improves pain relief and morphine consumption in mandibular osteotomies: a prospective, randomized, double-blind, placebo-controlled clinical trial. Reg Anesth Pain Med. 2021 Apr;46(4):322-327. doi: 10.1136/rapm-2020-102417. Epub 2021 Feb 9.


title: Value of Ultrasound for Evaluating Rheumatoid Arthritis in Remission: Longitudinal Study

acronym: SONORE

summary:
The objective of this study is to determine the longitudinal relation between clinical remission and ultrasound (US) remission in Rheumatoid arthritis (RA).

At a patient level, US-detected residual synovitis (evaluated both by US grey-scale signals and power Doppler signals) is frequent in patients with RA in clinical remission. Several longitudinal studies reveal an association of US-detected residual synovitis and risk of relapse and radiographic progression, in individual patients and joints, over 1-2 years.

However, the longitudinal relation between clinical remission and US remission is not so well-known and it is possible that clinical remission arrive before ultrasound remission. Thus arise the question as to whether the presence of US-detected residual synovitis require to adapt the treatment to ultrasound findings or to simply increase the patient care.

The investigator propose to conduct a prospective, bi-center, non randomized study.


title: Intravenous Versus Combined Oral and Intravenous Antimicrobial Prophylaxis for the Prevention of Surgical Site Infection in Elective Colorectal Surgery: A Double-blinded Multicenter Prospective Randomized Controlled Trial

acronym: COMBINE

summary: To assess the effects of a combined antimicrobial prophylaxis using oral ornidazole (the day before surgery) and intravenous cephalosporin (before surgical incision) with that of intravenous cephalosporin alone (standard of care) in combination with oral placebo on the incidence of SSI within 30 days after elective colorectal surgery.

ReferenceCitation: Futier E, Jaber S, Garot M, Vignaud M, Panis Y, Slim K, Lucet JC, Lebuffe G, Ouattara A, El Amine Y, Couderc P, Dupré A, De Jong A, Lasocki S, Leone M, Pottecher J, Pereira B, Paugam-Burtz C; COMBINE study group. Effect of oral antimicrobial prophylaxis on surgical site infection after elective colorectal surgery: multicentre, randomised, double blind, placebo controlled trial. BMJ. 2022 Nov 3;379:e071476. doi: 10.1136/bmj-2022-071476.

ReferenceCitation: Vignaud M, Paugam-Burtz C, Garot M, Jaber S, Slim K, Panis Y, Lucet JC, Bourdier J, Morand D, Pereira B, Futier E; COMBINE trial management committee. Comparison of intravenous versus combined oral and intravenous antimicrobial prophylaxis (COMBINE) for the prevention of surgical site infection in elective colorectal surgery: study protocol for a multicentre, double-blind, randomised controlled clinical trial. BMJ Open. 2018 Apr 12;8(4):e020254. doi: 10.1136/bmjopen-2017-020254.


title: Evaluation of the Efficiency of Bronchial Thermoplasty on Dynamic Hyperinflation in Uncontrolled Severe Asthma

acronym: HEAT-SA

summary:
Bronchial thermoplasty is a treatment for severe asthma that consist in decreasing the thickness of bronchial muscle by heat using a catheter inserted into the bronchi under direct vision with the help of an endoscope This treatment has shown efficacy on symptoms, quality of life and the number of exacerbations related to severe asthma.

This clinical study evaluates the efficiency of this treatment on the dynamic hyperinflation phenomenon (worsening of bronchial obstruction during exercise in patients with asthma contributing to worsening shortness of breath).

primary_purpose: Basic Science

ReferenceCitation: Moore WC, Bleecker ER, Curran-Everett D, Erzurum SC, Ameredes BT, Bacharier L, Calhoun WJ, Castro M, Chung KF, Clark MP, Dweik RA, Fitzpatrick AM, Gaston B, Hew M, Hussain I, Jarjour NN, Israel E, Levy BD, Murphy JR, Peters SP, Teague WG, Meyers DA, Busse WW, Wenzel SE; National Heart, Lung, Blood Institute's Severe Asthma Research Program. Characterization of the severe asthma phenotype by the National Heart, Lung, and Blood Institute's Severe Asthma Research Program. J Allergy Clin Immunol. 2007 Feb;119(2):405-13.

ReferenceCitation: Brown RH, Wizeman W, Danek C, Mitzner W. Effect of bronchial thermoplasty on airway distensibility. Eur Respir J. 2005 Aug;26(2):277-82.

ReferenceCitation: Cox G, Thomson NC, Rubin AS, Niven RM, Corris PA, Siersted HC, Olivenstein R, Pavord ID, McCormack D, Chaudhuri R, Miller JD, Laviolette M; AIR Trial Study Group. Asthma control during the year after bronchial thermoplasty. N Engl J Med. 2007 Mar 29;356(13):1327-37.

ReferenceCitation: Pavord ID, Cox G, Thomson NC, Rubin AS, Corris PA, Niven RM, Chung KF, Laviolette M; RISA Trial Study Group. Safety and efficacy of bronchial thermoplasty in symptomatic, severe asthma. Am J Respir Crit Care Med. 2007 Dec 15;176(12):1185-91. Epub 2007 Sep 27.

ReferenceCitation: Castro M, Rubin AS, Laviolette M, Fiterman J, De Andrade Lima M, Shah PL, Fiss E, Olivenstein R, Thomson NC, Niven RM, Pavord ID, Simoff M, Duhamel DR, McEvoy C, Barbers R, Ten Hacken NH, Wechsler ME, Holmes M, Phillips MJ, Erzurum S, Lunn W, Israel E, Jarjour N, Kraft M, Shargill NS, Quiring J, Berry SM, Cox G; AIR2 Trial Study Group. Effectiveness and safety of bronchial thermoplasty in the treatment of severe asthma: a multicenter, randomized, double-blind, sham-controlled clinical trial. Am J Respir Crit Care Med. 2010 Jan 15;181(2):116-24. doi: 10.1164/rccm.200903-0354OC. Epub 2009 Oct 8.

ReferenceCitation: Wechsler ME, Laviolette M, Rubin AS, Fiterman J, Lapa e Silva JR, Shah PL, Fiss E, Olivenstein R, Thomson NC, Niven RM, Pavord ID, Simoff M, Hales JB, McEvoy C, Slebos DJ, Holmes M, Phillips MJ, Erzurum SC, Hanania NA, Sumino K, Kraft M, Cox G, Sterman DH, Hogarth K, Kline JN, Mansur AH, Louie BE, Leeds WM, Barbers RG, Austin JH, Shargill NS, Quiring J, Armstrong B, Castro M; Asthma Intervention Research 2 Trial Study Group. Bronchial thermoplasty: Long-term safety and effectiveness in patients with severe persistent asthma. J Allergy Clin Immunol. 2013 Dec;132(6):1295-302. doi: 10.1016/j.jaci.2013.08.009. Epub 2013 Aug 30.

ReferenceCitation: Guibert N, Guilleminault L, Lepage B, Heluain V, Fumat R, Dupuis M, Faviez G, Plat G, Hermant C, Didier A. Bronchial thermoplasty in patients with dynamic hyperinflation: results from the proof-of-concept HEAT trial. Eur Respir J. 2021 Jan 28;57(1). pii: 2001616. doi: 10.1183/13993003.01616-2020. Print 2021 Jan.

lead_sponsor: University Hospital, Toulouse


title: Creation of a Multimodality Image Database (MRI + Ultrasound) for the Development of a Computer Aided Diagnostic (CAD) System in Patients With Prostate Cancer

acronym: Echo-CAD

summary:
Prostate cancer is currently detected by ultrasound-guided biopsy. Computer-aided diagnostic (CAD) systems based on multiparametric MRI are now capable of detecting most aggressive cancer foci non-invasively, but additional progress is needed for the technique to be accepted in clinical practice. We hypothesize that combining MRI and ultrasound imaging can improve the detection of cancerous tumors. As a first step in this direction, we need to create a database with MR images, 3D ultrasound images, and corresponding histopathology results, in patients treated by radical prostatectomy for prostate cancer. This is the purpose of the present study.

In a later stage (outside the scope of this study), we will be learning how to combine these images to best recognize cancerous tumors, we will use that knowledge to develop a new CAD system, and we will assess the performance of the new CAD. We expect this future system to improve the detection of prostate cancer and to reduce the number of patients requiring biopsy.

location_facility: Hôpital Edouard Herriot - Service Service de radiologie


title: Prognostic Value of Hemodynamic Disturbances of the Central Retinal Artery in Color Doppler Ultrasound in Rhegmatogenous Retinal Detachment

acronym: CRADO-RED

summary:
Retinal detachments correspond to a separation of the neuroepithelium from the pigment epithelium. They can be exudative (sometimes in conjunction with a tumor), tractional, traumatic (postoperative) or rhegmatogenous (in relation to a tear).

Ultrasound, requested when the fundus is difficult to achieve and shows a hyperechoic mobile membrane. It can also measure the hemodynamic parameters of retinal arteries.

A preliminary study showed a correlation between systolic velocity in the central retinal artery and postoperative visual acuity.

The aim of this study is to confirm those preliminary data.

status: Terminated

lead_sponsor: Fondation Ophtalmologique Adolphe de Rothschild

location_facility: Fondation ophtalmique Adolphe de Rothschild


title: Impact of the Platelet Level During Radiotherapy Associated With Temozolomide in Patients Treated for Glioblastoma

acronym: GLIOPLAK

summary: The purpose of GLIOPLAK is to evaluate the predictive value of a biological test performed in the radio-chemotherapy phase in patients suffering from glioblastoma. The studied parameter is the variation in platelet count during the radio-chemotherapy phase. The main objective is to identify early in Stupp protocol a group of patients having high risk to undergo thrombocytopenia in maintenance phase of temozolomide. With this result an algorithm of platelet monitoring for patients treated with Stupp protocol wil be proposed.

ReferenceCitation: Fontanilles M, Marguet F, Beaussire L, Magne N, Pépin LF, Alexandru C, Tennevet I, Hanzen C, Langlois O, Jardin F, Laquerrière A, Sarafan-Vasseur N, Di Fiore F, Clatot F. Cell-free DNA and circulating TERT promoter mutation for disease monitoring in newly-diagnosed glioblastoma. Acta Neuropathol Commun. 2020 Nov 4;8(1):179. doi: 10.1186/s40478-020-01057-7.

lead_sponsor: Centre Henri Becquerel


title: Pre-operative Haemorrhagic Risk Screening, Using a Standardized Questionnaire Before Scheduled Surgeries.

acronym: HEMORISQ

summary:
"This is not a validation study of a questionnaire. This is a multicenter diagnostic study, assessing the sensitivity and specificity of a simple structured questionnaire, to identify patients requiring further haemostatic investigations, in pre-operative patients. This study will also allow for the assessment of the sensitivity and specificity of the routine care strategy.

All patients are recruited during the pre-anaesthesia visit by an anaesthesiologist, in different anaesthetic sectors each day of the week, so that different types of surgery are represented.

Each day (from Monday to Friday), the first 2 eligible patients will be offered to take part in the study.

Routine care strategy is not modified by the study protocol. In addition, the simple structured questionnaire will be completed by the patient with a research assistant after the pre-operative consultation As recommended in diagnostic studies, the gold standard (see secondary endpoint paragraph) will be performed consistently in all patients to avoid verification bias.

The improvement of screening for the need of further investigations by use of the questionnaire compared to routine care will be measured counting how many patients are adequately reclassified with the questionnaire compared to the routine care strategy, regarding the gold standard (using the Net Reclassification Index)."

ipd_sharing: Undecided


title: Assessment of Loading With the P2Y12 Inhibitor Ticagrelor or Clopidogrel to Halt Ischemic Events in Patients Undergoing Elective Coronary Stenting: The ALPHEUS Study

acronym: ALPHEUS

summary:
The new P2Y12 inhibitors prasugrel (Efient®-Effient®) and ticagrelor (Brilique®-Brilinta®) have shown promising results in the respective TRITON and PLATO trials making of prasugrel and ticagrelor recommended first line treatments for acute coronary syndrome ACS (ESC Guidelines: Class 1 LOE B). These two drugs showed superiority over clopidogrel in ACS patients undergoing percutaneous coronary intervention (PCI), by the dramatic diminution of stent thrombosis, the reduction in death or Myocardial Infarction (MI) as well as the reduction in death in a meta-analysis.

The field of elective PCI (stable patients) has not been studied with these 2 new drugs and clopidogrel remains the standard of care. However, off-label use of prasugrel and ticagrelor is increasing in patients undergoing high risk elective PCI (left main, diabetics, multiple stenting, high risk of stent thrombosis, no clopidogrel pretreatment…) but is not supported by scientific evidence. More than half of PCI patients undergo elective stenting for proven ischemia and/or stable angina, a relatively safe procedure with the use of the latest generation of stents. However complications remain either frequent when considering PCI-related myonecrosis/myocardial injury that have been linked to the prognosis of patients or rare but serious when considering stent thrombosis, Q wave MI or stroke, leaving room for improvement with these two newest drugs.

The investigators propose to perform a multicenter international study in stable patients undergoing elective PCI with a randomization between clopidogrel and ticagrelor. The investigators hypothesize that this study will show superiority of the new P2Y12 inhibitor over clopidogrel in elective PCI on the primary ischemic endpoint (peri-procedural MI and myocardial injury) without significant excess bleeding (BARC definition).

ReferenceCitation: Silvain J, Lattuca B, Beygui F, Rangé G, Motovska Z, Dillinger JG, Boueri Z, Brunel P, Lhermusier T, Pouillot C, Larrieu-Ardilouze E, Boccara F, Labeque JN, Guedeney P, El Kasty M, Laredo M, Dumaine R, Ducrocq G, Collet JP, Cayla G, Blanchart K, Kala P, Vicaut E, Montalescot G; ALPHEUS investigators. Ticagrelor versus clopidogrel in elective percutaneous coronary intervention (ALPHEUS): a randomised, open-label, phase 3b trial. Lancet. 2020 Nov 28;396(10264):1737-1744. doi: 10.1016/S0140-6736(20)32236-4. Epub 2020 Nov 14.

ReferenceCitation: Silvain J, Cayla G, Beygui F, Range G, Lattuca B, Collet JP, Dillinger JG, Boueri Z, Brunel P, Pouillot C, Boccara F, Christiaens L, Labeque JN, Lhermusier T, Georges JL, Bellemain-Appaix A, Le Breton H, Hauguel-Moreau M, Saint-Etienne C, Caussin C, Jourda F, Motovska Z, Guedeney P, El Kasty M, Laredo M, Dumaine R, Ducrocq G, Vicaut E, Montalescot G; ALPHEUS study group. Blunting periprocedural myocardial necrosis: Rationale and design of the randomized ALPHEUS study. Am Heart J. 2020 Jul;225:27-37. doi: 10.1016/j.ahj.2020.04.017. Epub 2020 Apr 29.

location_facility: Institut de Cardiologie - USIC - Hôpital Pitié-Salpêtrière


title: Comparison of the Efficacy and Safety of T2762 Versus Optive® in the Treatment of Moderate to Severe Dry Eye Syndrome

summary: The purpose of this study is to compare the efficacy and safety of T2762 versus Optive® in the treatment of moderate to severe Dry Eye Syndrome.

lead_sponsor: Laboratoires Thea


title: Developing a Program for Transition to Adult Care for Youth With Chronic Conditions : a Mixed Method Study

acronym: TRANSAD

summary: Investigation in 3 steps the transition of young people with chronic diseases. FIRST STEP: qualitative survey. Interviews with carers, young people and parents. Chronic Diseases studied: epilepsy, HIV, sickle cell disease, obesity. SECOND STEP: Delphi consensus survey. Vote on internet : carers, patients' associations, young people and family. Chronic Diseases studied: all. THIRD STEP: validation survey. Vote on internet : young people. Chronic Diseases studied: all.


title: Buspirone Treatment of Iatrogenic Dyskinesias in Advanced Parkinson' Disease. Multicenter, International, Placebo-controlled, Randomised, Double Blind Trial

acronym: BUSPARK

summary:
Parkinson's disease (PD) is one of the most common neurodegenerative diseases, with a higher prevalence in the elderly. Levodopa induced dyskinesias (LID) are a major motor complications that impair quality of life for patients with PD. The mechanisms of these dyskinesias remain unclear, but several hypotheses have been put forward: non continuous, pulsatile stimulation of dopaminergic receptors, or alterations of other neurotransmitters within the motor striatum such as glutamate and serotonin.

Few strategies are now available to treat severe LID:

Medications: reduction of dopaminergic treatment, addition of amantadine,
Functional neurosurgery. The purpose of this study is to investigate the efficacy of buspirone in PD patients suffering from dyskinesias. The role of serotonin in the occurrence of LID was recently demonstrated in transplant PD patients and a test double-blind, single dose was achieved. Following administration of 10 mg oral buspirone, a 5HT1A agonist, LID were clearly improved. A antidyskinetic effect of buspirone had already been reported in 1991 and 1994, but identification of buspirone as a serotonin receptor agonist has been reported more recently.

This trial is aimed at (1) validate the serotoninergic hypothesis of hyperkinetic levodopa induced dyskinesias (LID) in Pakinson's disease patients, (2) evaluate, in a phase 3 trial, the motor efficacy of buspirone to improve LID vs placebo, (3) look at a possible dose/effect relationship and (4) check the hypothesis of a better therapeutic ratio using the association of buspirone and amantadine instead than a single drug.

ReferenceCitation: McFarthing K, Prakash N, Simuni T. CLINICAL TRIAL HIGHLIGHTS - DYSKINESIA. J Parkinsons Dis. 2019;9(3):449-465. doi: 10.3233/JPD-199002. Review.


title: Multicenter Trial Treatment of Philadelphia Chromosome Negative (Ph-) B-lineage Acute Lymphoblastic Leukemia (ALL) of Young Adults (18-59 Years).

summary: The purpose of this study is to prospectively validate the new risk model, based on minimal residual disease (MRD) response level and oncogenetic status by comparing historical results of GRAALL-2005 with those of GRAALL-2014 in an identical population of patients (Philadelphia chromosome negative, B lineage ALL, aged 18 to 59 years old).

location_facility: Hématologie Adulte, Saint Louis hospital


title: Contribution of CT Venography for Diagnosing Venous Thromboembolism During Postpartum

acronym: CTVENPOSTPART

summary: The purpose of this study is to determine whether systematically performing computed tomography (CT) venography (i.e a CT acquisition of the pelvis and of the lower limbs, during the venous phase of opacification) in addition to thoracic CT angiography in women with suspected postpartum pulmonary embolism (PE) results in a gain in venous thromboembolism detection rate.

ReferenceCitation: Revel MP, Sanchez O, Dechoux S, Couchon S, Frija G, Cazejust J, Chatellier G, Meyer G. Contribution of indirect computed tomographic venography to the diagnosis of postpartum venous thromboembolism. J Thromb Haemost. 2008 Sep;6(9):1478-81. doi: 10.1111/j.1538-7836.2008.03078.x. Epub 2008 Jul 8.


title: Characterization of B Regulatory (Breg) Cells in Healthy Subjects and in Rheumatoid Arthritis (RA)

acronym: Breg

summary:
Recently, it has been shown that B cells could also have regulatory functions through the secretion of interleukin 10 (IL-10). They are called the B regulatory cells (Breg). In the mouse model the most commonly used of rheumatoid arthritis, collagen-induced arthritis (CIA), the transfer Breg helps prevent the development of CIA and cure established arthritis. The investigators have recently shown that Breg were decreased in patients with RA compared to controls and that the rate of Breg was inversely correlated with disease activity and autoantibody. These results thus suggest that the lack of IL-10 secretion by B cells plays an important role in the pathophysiology of RA. Nevertheless, in humans, the Breg remain poorly understood. The main objective of this project is to better characterize the B capable of producing IL-10 both in subjects with RA and controls. Understanding which induces the secretion of IL-10 by B could allow to consider new therapeutic approaches in autoimmune diseases, including in RA.

The investigators therefore aim to identify nutrient transporters, chemokine receptors, genes and surface proteins differentially expressed between Breg and other B cells in patients with RA and in controls.


title: Prospective Pilot Study on the Quantitative Evaluation of Vision Parameters Needed by Virtual Reality Goggle Displays for Subjects With Concentric Visual Field Constriction. AUgmented REality for the Visually Impaired - Part 1

acronym: AUREVI 1

summary:
The main objective of this study is to quantify vision parameters in subjects with concentric visual field constriction, and this in relation to the display on virtual reality goggles. More specifically:

The maximum brightness value for visual comfort (THRESHOLD_MAX)
The minimum value of the perceptible light contrast in low light perceptible (THRESHOLD_MIN)
The speed of light change adaptation in the range [THRESHOLD_MAX-THRESHOLD_MIN] and [THRESHOLD_MIN-THRESHOLD_MAX].

lead_sponsor: Centre Hospitalier Universitaire de Nīmes

location_facility: CHRU de Nîmes - Hôpital Universitaire Carémea


title: Evaluation of the Impact of the Presence of a Pharmacy Technician on the Quality and Cost of Drug Therapy in the Hepato-Gastroenterology Department of the Nîmes University Hospital

acronym: OPTI-PP

summary:
The main objective of this study is to evaluate the impact of the presence of a pharmacy technician in a care unit (Hepato-Gastroenterology Department) on detected medication errors.

This is a before-after study consisting of three sequential phases:

Month 1: one month of observation of what is happening in the department Month 2: one month wash out period Month 3: active participation of a pharmacy technician in the department

location_facility: CHRU de Nîmes - Hôpital Universitaire Carémeau


title: Bariatric Surgery for Obese Patients With Chronic Renal Insufficiency

acronym: BOKID

summary:
The creatinine clearance will be measured using two consecutive 24 hour urine collections, with the objective of minimizing errors due to poor quality urine collection.

The GFR will be measured by a reference method, because its estimation from blood creatinine levels (eGFR) by the MDRD study formula may be confounded by variations in muscle mass, and therefore creatinine production, following bariatric surgery. The method will remain the same in each center, and therefore consistent for any given patient, throughout the duration of the study. The GFR measurements will be performed after stopping any medication blocking the RAAS, and reducing diuretics for one week, with the introduction or increase of alpha-blockers or centrally-acting hypotensive agents. If it is impossible to stop RAAS-blockade (heart failure), the dose will at least be reduced for one week. This precaution is required to minimize the bias of functional renal insufficiency because the state of extracellular hydration is difficult to assess in obese subjects. Subsequent measurements of GFR will be performed in the same way.

The choice of the tracer to measure GFR may vary according to study center. 51Cr-EDTA, 99Tc-DTPA, iohexol or inulin may all be utilized. Because the assessment of edema is hazardous in extremely obese patients and because kidney disease favors edema formation, the simplified single injection method and the determination of plasma clearance measurement of the tracer is not reliable . Only the constant infusion method will be used to measure GFR. Briefly, GFR will be determined by calculating the glomerular clearance (Cl) from plasma concentrations (P) and renal excretions per unit of time (UxV) during infusion at a constant plasma level of the tracer (Cl=UxV/P). The result will be given as mean value of several consecutive clearances. Because correct urine collection is key for the procedure, seven collection periods (instead of 5 usually) will be performed for the calculation of the mean clearance. Bladder catheterization will be used only when it can be anticipated that the patient will not void satisfactorily. In the last 30 consecutive patients with mGFR below 60 ml/min/1,73m2, this occurred twice and the subjects were 70 and 79 years old. Therefore, this might occur exceptionably in the study. Raw data from each center will be sent to the coordination center (Nice) to examine and validate the calculation of mean clearance values. To that aim, extreme and non-representative clearances will be excluded. At least 3 of the 7 periods will be taken into account to calculate the mean values. For instance, in the last 30 consecutive patients with mGFR below 60 ml/min/1,73m2, investigators considered on average 4.7 periods and obtained a mean non-indexed GFR value of 40,7 ± 2,5 ml/min.

Primary assessment will be performed at one year, as a previous study has already suggested a significant benefit within this period [66], and because surgery can't be delayed further in these patients strongly expecting the intervention, but follow-up will be extended to three years or until the end of the study, in order to document whether the initial benefits of surgical intervention are maintained.

A reduction in the absolute value of measured GFR (mGFR) following bariatric surgery is expected in the first six months after surgery (M0 - M6). However, the weight loss may allow an increased in mGFR indexed to body surface area up until M6, and above all towards M12.
the investigators expect a subsequent stabilization of mGFR between M12 and M36 in the bariatric surgery group, and will seek to measure the anticipated reduction in mGFR in the control group who remain in a state of glomerular hyperfiltration.

All relevant cardiovascular, metabolic and nutritional parameters necessary to study the risk/benefit ratio of the intervention will be analyzed.

Primary: bariatric surgery slows the progression of chronic kidney disease in the obese.
Secondary: bariatric surgery improves survival, cardiovascular prognosis, metabolic, nutritional and inflammatory parameters, quality of life, and access to transplantation in the sub-group of patients whose GFR < 20ml/min/1.73m2 at inclusion, and there could be a chance loss for the patients in delaying surgery by one year.

lead_sponsor: Centre Hospitalier Universitaire de Nice


title: Interest of Combining Speech Therapy With a Non-invasive Brain Stimulation (tDCS) for the Aphasic Patient

acronym: Taph

summary: Aphasia is a frequent symptom after a left hemisphere stroke. It has serious impacts on social, family and professional lives. Aphasic patients need to be rehabilitated. To date, no pharmacological treatment being available only speech and language therapy (SLT) can improve patients, but its efficiency is moderate. Several studies have investigated the link between the recovery of language and neural reorganization. tDCs, a noninvasive technology for modulating neural excitability, could potentiate the effects of the SLT. About 25 studies in literature have described beneficial effects of tDCs coupled with SLT on aphasic patients. However to the investigator knowledge the feasibility of tDCs and speech therapy in clinical pathways has never been investigated. That is why the investigator propose to study in real care conditions how SLT proves more efficient on the recovery of language in a discursive assessment when coupled with active stimulation than with placebo stimulation.

ReferenceType: result

ReferenceCitation: Greener J, Enderby P, Whurr R. Speech and language therapy for aphasia following stroke. Cochrane Database Syst Rev. 2000;(2):CD000425. Review. Update in: Cochrane Database Syst Rev. 2010;(5):CD000425.

ReferenceCitation: Nitsche MA, Paulus W. Excitability changes induced in the human motor cortex by weak transcranial direct current stimulation. J Physiol. 2000 Sep 15;527 Pt 3:633-9.

ReferenceCitation: Elsner B, Kugler J, Pohl M, Mehrholz J. Transcranial direct current stimulation (tDCS) for improving aphasia in patients with aphasia after stroke. Cochrane Database Syst Rev. 2015 May 1;(5):CD009760. doi: 10.1002/14651858.CD009760.pub3. Review. Update in: Cochrane Database Syst Rev. 2019 May 21;5:CD009760.

ReferenceCitation: Robey RR. A meta-analysis of clinical outcomes in the treatment of aphasia. J Speech Lang Hear Res. 1998 Feb;41(1):172-87.

ReferenceCitation: Klippi A, Sellman J, Heikkinen P, Laine M. Current clinical practices in Aphasia Therapy in Finland: challenges in moving towards national best practice. Folia Phoniatr Logop. 2012;64(4):169-78. doi: 10.1159/000341106. Epub 2012 Oct 25.

lead_sponsor: Centre d'Investigation Clinique et Technologique 805


title: A Cohort Survey of Patients With Metastatic Colorectal Cancer Starting a Chemotherapy in Combination With Avastin®

acronym: CONCERT

summary: This is a longitudinal, multicenter, prospective, pharmacoepidemiological study to evaluate progression free survival (PFS) in a real-life setting in participants with metastatic colorectal cancer (mCRC) starting chemotherapy combined with bevacizumab.

lead_sponsor: Hoffmann-La Roche


title: French Aspirin Study in Essential Thrombocythemia: an Open and Randomized Study

acronym: FAST

summary:
The hypothesis is that efficient prevention of thrombosis with aspirin at diagnosis becomes less useful once patients have achieved a hematologic response (HR) (modified by amendment 1/03/2017) and/or that this benefit is hampered by an increased hemorrhagic risk especially in elderly patients.

Hence, investigator propose a prospective randomized study to assess the benefit / risk ratio of aspirin maintenance in high risk Essential thrombocythemia (ET) patients, in hematological response (modified by amendment 1/03/2017) on Hydroxyurea.

ReferenceCitation: Alvarez-Larrán A, Pereira A, Arellano-Rodrigo E, Hernández-Boluda JC, Cervantes F, Besses C. Cytoreduction plus low-dose aspirin versus cytoreduction alone as primary prophylaxis of thrombosis in patients with high-risk essential thrombocythaemia: an observational study. Br J Haematol. 2013 Jun;161(6):865-71. doi: 10.1111/bjh.12321. Epub 2013 Apr 12.

ReferenceCitation: Barbui T, Barosi G, Birgegard G, Cervantes F, Finazzi G, Griesshammer M, Harrison C, Hasselbalch HC, Hehlmann R, Hoffman R, Kiladjian JJ, Kröger N, Mesa R, McMullin MF, Pardanani A, Passamonti F, Vannucchi AM, Reiter A, Silver RT, Verstovsek S, Tefferi A; European LeukemiaNet. Philadelphia-negative classical myeloproliferative neoplasms: critical concepts and management recommendations from European LeukemiaNet. J Clin Oncol. 2011 Feb 20;29(6):761-70. doi: 10.1200/JCO.2010.31.8436. Epub 2011 Jan 4.

ReferenceCitation: Barosi G, Birgegard G, Finazzi G, Griesshammer M, Harrison C, Hasselbalch HC, Kiladjian JJ, Lengfelder E, McMullin MF, Passamonti F, Reilly JT, Vannucchi AM, Barbui T. Response criteria for essential thrombocythemia and polycythemia vera: result of a European LeukemiaNet consensus conference. Blood. 2009 May 14;113(20):4829-33. doi: 10.1182/blood-2008-09-176818. Epub 2009 Mar 10.

ReferenceCitation: Barosi G, Mesa R, Finazzi G, Harrison C, Kiladjian JJ, Lengfelder E, McMullin MF, Passamonti F, Vannucchi AM, Besses C, Gisslinger H, Samuelsson J, Verstovsek S, Hoffman R, Pardanani A, Cervantes F, Tefferi A, Barbui T. Revised response criteria for polycythemia vera and essential thrombocythemia: an ELN and IWG-MRT consensus project. Blood. 2013 Jun 6;121(23):4778-81. doi: 10.1182/blood-2013-01-478891. Epub 2013 Apr 16.

ReferenceCitation: Barosi G, Birgegard G, Finazzi G, Griesshammer M, Harrison C, Hasselbalch H, Kiladijan JJ, Lengfelder E, Mesa R, Mc Mullin MF, Passamonti F, Reilly JT, Vannucchi AM, Barbui T. A unified definition of clinical resistance and intolerance to hydroxycarbamide in polycythaemia vera and primary myelofibrosis: results of a European LeukemiaNet (ELN) consensus process. Br J Haematol. 2010 Mar;148(6):961-3. doi: 10.1111/j.1365-2141.2009.08019.x. Epub 2009 Nov 23. Review.


title: STT Study : Pediatric Follow-up of Children's From Monochorial-diamniotic Pregnancies Complicated With a Twin-to-twin Syndrome

acronym: STT

summary:
The twin pregnancies monochorionic are specifically explained to two main types of complications: the anomalies of the embryo affecting a symmetry and in particular the median line on one hand and malformative sequences of vascular origin on the other hand. This last category of anomalies (twin-to-twin syndrome, TTTS) develops because of the presence of a division of the foeto-placentary circulation between both twins through the pooling of certain placentary cotyledons. The latter are then vascularized by an arterial and venous foot belonging to both foetuses (anastomoses arteria-venous or veinous-arterial). It results from it an imbalance moderate but very early hemodynamic which is going to return a hypovolume twin (the donor) and its plethoric co-twin (the recipient).

These anomalies in utero could not only have consequences during the fetal life, on the born weight and the later development of newborns, but also on the organization and the functioning of a whole series of physiological systems. So these anomalies of the pregnancy could have also consequences which exceed by very far from the perinatal period, by favoring the development of the atheroma, the high blood pressure, the resistance in the insulin, and many other metabolic and endocrine functions were known for their importance in human pathology.

For these reasons the investigators suggest estimating the tensional, cardiac and metabolic status of children ex-transfusers and of children ex-transfused in 2 different age classes: between 4 and 8 years then when these children will have between 12 and 16 years.

There are also some evaluation clinical and biological of the puberty (only at the age of 12-16)

To understand a possible effect of the prenatal status of these children on the endocrinology of the puberty, the measures and the following dosages will be realized:

Test in the GnRH (T0, T30, T60, T90): dosages of LH and FSH (relationship of peaks to determine the puberty evolution),
Dosages of the sexual steroids, the oestradiol for the girl and the testosterone for the boy,
Clinical examination looking for the signs of puberty

This if study leans on the big originality of the physiopathological model of TTTS in which the children present the peculiarity to have an identical genetic and postnatal status and a different prenatal environment.

The follow-up of these children should allow:

To understand better the postnatal impact anomalies on these children in the course of pregnancy
To anticipate and thus to improve their care in case of appearance of biological or clinical signs

time_perspective: Retrospective


title: A Phase III Study, Randomized, to Evaluate the Reduction of Chemotherapy Intensity in Association With Nilotinib (Tasigna®) in Philadelphia Chromosome-positive (Ph+) ALL of Young Adults (18-59 Years Old) (GRAAPH-2014)

summary: The Primary objective is to assess the non-inferiority of the experimental arm (arm B) compared to the control arm (arm A) in terms of Major Molecular Response (MMolR) after the 4th cycle (MRD4) in patients aged 18-59 years old with de novo Philadelphia positive (Ph+) acute lymphoblastic leukemia (ALL)


title: Comparison of the PillCamCOLON (C2) Capsule With Standard Endoscopy for the Evaluation of the Severity and the Endoscopic Healing of Patients With Ulcerative Colitis (UC)

summary:
Ulcerative colitis (UC) is an inflammatory bowel disease progressing through flare-ups. The therapeutic objective, which was originally based on clinical remission, is currently evolving with the development of biotherapies towards the achievement of endoscopic remission. Current recommendations for therapeutic management advocate the achievement of endoscopic mucosal healing (EMH), with an observed decrease in the necessity for colectomy in the case of EMH. Endoscopic evaluation of the severity of UC is performed during a digestive endoscopy (colonoscopy for a complete colonic exploration, or recto-sigmoidoscopy for a partial exploration of the colon) from endoscopic activity scores adapted for UC.

Currently, the score the most commonly used is the MAYO endoscopic score. This is a global score of increasing intensity from 0 to 3, taking into account the following basic lesions: vascular pattern, granularity or/and friability of the mucosa, spontaneous bleeding, erosion and ulceration. However this score has limits: it does not distinguish deep cavitating ulcerations with mucous detachment from simple ulcerations which have a better prognosis.

A new endoscopic score specific for UC has been developed and is currently being validated. It is termed Ulcerative Colitis Endoscopic Index of Severity (UCEIS). This evaluation takes into account the three most reproducible factors - the vascular pattern, the presence of bleeding, and erosions or ulcerations including cavitating ulceration - in the total score.

To ensure optimal patient care and an adaptation of the therapeutic medical care to the endoscopic severity of the disease, endoscopic exploration should be performed recurrently. However, this exploration is an invasive procedure, requires general anaesthesia for colonoscopy, and can lead to potential complications such as perforation. This explains the poor acceptance by patients, resulting in a sub-optimal therapeutic support.

lead_sponsor: Dr. Arnaud Bourreille


title: Assessing the Impact of Clown Therapy in a Palliative Care Unit: A Prospective, Descriptive Study

acronym: OUPS

summary: The main objective of this study was to assess changes in the quality of life of patients in a Palliative Care Unit via the symptoms by the Edmonton Symptom Assessment System (ESAS) before and one hour after the passage of a clown therapist .


title: Evaluation of Spinal Mobility Reeducation in Patients Treated for a Lumbar Spinal Stenosis After Epidural Infiltration. Randomized and Comparative Study: Kyphosis Reeducation Versus Spinal Mobility Reeducation

acronym: CLEMOB

summary: In actual practice the patients with mild or moderate lumbar spinal stenosis symptoms receive an epidural infiltration and participate in kyphosis reeducation in first intention. Yet the kyphosis reeducation did not show a real profit in the time compared with the natural evolution of the pathology. The study assume that the spinal mobility reeducation will reduce the incidence of pain recurrences compared with the classic kyphosis reeducation.

ReferenceCitation: Berney J. [Epidemiology of narrow spinal canal]. Neurochirurgie. 1994;40(3):174-8. French.

ReferenceCitation: Weinstein JN, Lurie JD, Tosteson TD, Hanscom B, Tosteson AN, Blood EA, Birkmeyer NJ, Hilibrand AS, Herkowitz H, Cammisa FP, Albert TJ, Emery SE, Lenke LG, Abdu WA, Longley M, Errico TJ, Hu SS. Surgical versus nonsurgical treatment for lumbar degenerative spondylolisthesis. N Engl J Med. 2007 May 31;356(22):2257-70.

ReferenceCitation: Yamashita K, Ohzono K, Hiroshima K. Five-year outcomes of surgical treatment for degenerative lumbar spinal stenosis: a prospective observational study of symptom severity at standard intervals after surgery. Spine (Phila Pa 1976). 2006 Jun 1;31(13):1484-90.

ReferenceCitation: Rillardon L, Guigui P, Veil-Picard A, Slulittel H, Deburge A. [Long-term results of surgical treatment of lumbar spinal stenosis]. Rev Chir Orthop Reparatrice Appar Mot. 2003 Nov;89(7):621-31. French.

ReferenceCitation: Lieberman I. Surgery reduced pain and disability in lumbar spinal stenosis better than nonoperative treatment. J Bone Joint Surg Am. 2007 Aug;89(8):1872.

lead_sponsor: University Hospital, Bordeaux

location_facility: University Hospital of Bordeaux - Hospital Pellegrin


title: Coding and Memorisation of Phonologic Information Among Preschool and School Children With Oral Language Developement Disorder.

acronym: MEMENTO

summary:
The disorder of oral language development is defined by the delay in language acquisition in children who possess efficient auditory acuity and normal non verbal intellect.

The diversity of language developement disorders depends either in the expressive level or in the receptive level leading to divers syndromes and symptoms. These syndromes and symptoms are regrouped under the name of STOL (Specific Troubles of Oral Language).

In the current project the visual exploitation and learning capability of children presenting a STOL condition will be compared to patients with a normal development. The investigator's hypothesis is as follows: STOL patients for whom the STOL disorder is reduced between 4 and 7 years of age will present a better performance at verbal memorisation, compared to patients with a persistent STOL condition after the age of 6.

lead_sponsor: Lille Catholic University


title: Assessment of Body Composition Via Dual-energy X-ray Absorptiometry Bone Densitometry: Cross Calibration and Reproducibility Between the "Stratos DR" and "Discovery A" Bone Densitometers

acronym: STRATOS

summary:
The main objective of this study is to validate the measurement characteristics of a new bone densitometer, the Stratos DR:

Via cross calibration to the results of body composition (BC) measurement results to those of a reference device (the "Discover A" by Hologic) in terms of body fat percentage, lean mass percentage of total body mass and for different subregions (left and right arms, left and right sides, lumbar and thoracic spine, pelvis, left and right legs, head, android area, gynecoid area, visceral region).
And by the evaluation of the reproducibility of the BC measurement results in terms of fat mass and lean mass.


title: Prognostic Impact of Myocardial Longitudinal Strain in Asymptomatic Aortic Stenosis: a Meta-Analysis

summary: In patients with asymptomatic aortic stenosis (AS), the prognostic value of reduced left ventricular (LV) ejection fraction is well known. Consequently, there is class I indication for surgery in these patients when LV ejection fraction <50%. However, there is growing evidences suggesting that subclinical LV dysfunction, and more particularly longitudinal myocardial dysfunction, may be a powerful early predictor of outcome, even when LV ejection is still preserved. In asymptomatic AS patients with LV ejection fraction >50%, a reduced LV global longitudinal strain, as assessed using speckle tracking imaging with transthoracic echocardiography, may be an accurate marker to identify early subclinical LV dysfunction and thus, to improve the risk stratification, the management and the timing of surgery. Several mono-centric observational small studies recently reported results emphasizing the role of LV global longitudinal strain in AS patients. Therefore, a meta-analysis may be conducted and may provide meaningful data. The investigators hypothesized that LV global longitudinal strain is a determinant of outcome in asymptomatic patients with AS and preserved LV ejection fraction.

lead_sponsor: European Association of Cardiovascular Imaging


title: A Prospective Pilot Study to Evaluate a New Marker of Ischemia in Chest Pain Triage

summary:
A Single-center prospective pilot study enrolling chest pain patients. CD 26 measurement will be performed and compared to troponin µs for early triage of these patients. This novel biomarker of myocardial ischemia (CD26) will be measured at the time of first medical contact (T0) and after 30 min simultaneously o troponin Ic.

All patients aged over 18 years with chest pain which may be related to acute coronary syndrome requiring pre hospital medical contact through the Emergency Medical Service.

lead_sponsor: Assistance Publique Hopitaux De Marseille

location_facility: Assistance Publique Hopitaux de Marseille


title: Impact of [68 Ga]-DOTANOC PET-CT on the Management of Gastroenteropancreatic Neuroendocrine Tumors (GEP-NETs): Prospective, Multicentric Study.

acronym: GEP-NOC

summary:
Somatostatin receptors are overexpressed in GEP-NETs and can be visualized in vivo by radiolabeled somatostatin-analogs.

During the last decades, conventional scintigraphy using 111In-DTPA-Octreotide (often named somatostatin receptor scintigraphy or SRS) was considered as the gold standard nuclear imaging technique in the evaluation of GEP-NETs. However, SRS may be suboptimal in this clinical setting because of the low intrinsic resolution of the technique and its selectivity for SST2 only. Its overall sensitivity is estimated to 60-70% (per lesion analysis), even when using the most recent SPECT-CT cameras. MRI have also a higher sensitivity than CT and SRS for the detection of liver metastases from GEP-NETs.

In recent years, positron emission tomography (PET) imaging, a high resolution and sensitive technology, has gained an increasing role in oncology. It has also been evaluated in GEP-NETs with somatostatin agonists (SSTa) radiolabelled with Gallium-68 [68Ga], a positron emitter with very promising results. Its diagnostic sensitivity is clearly superior to SRS and many European centers have already replaced SRS by [68Ga]-PET-SSTa.

Currently, three different [68Ga]-coupled peptides can be used in trials: DOTA-TOC, DOTA-TATE and DOTA-NOC with excellent affinities for SST2 (IC50: 2.5; 0.2 and 1.9 nM, respectively). Sensitivities of DOTA-TOC and DOTA-TATE PET/CT are quite similar.

[68Ga]-DOTANOC which also binds to SST5 was recently found to detect significantly more lesions than the SST2-specific radiotracer [68Ga]-DOTATATE in patients with GEP-NETs but this requires further evaluation.

It is therefore important to determine the interest of [68Ga]-DOTANOC combined with the standard diagnosis strategy in GEP-NETs and evaluate medicoeconomic impact of adding [68Ga]-DOTANOC in the work-up of patients.

The investigators hypothesis is that [68Ga]-DOTANOC will modify the management in at least 20% of patients in a more adapted way according to the 2012 ENETS guidelines in comparison to the decision based on the standard imaging work up (multiphasic WB CT, liver MRI and SRS).

110 patients will be included prospectively in 5 different French experienced centers (Marseille, Bordeaux, Toulouse, Paris, Clermond-Ferrand).


title: Effect in the Short and Medium Term of Different Techniques of Tactile Stimulations on Neurological Development in a Population of Very Preterm Infants

summary:
Premature birth deprives infants of sensory stimulation. Tactile stimulation such as massage pressure with kinesthetic movement significantly increases the weight, bone density and shorten the duration of stay of premature babies who benefits.

Studies using vegetable oils show an increase in the effect on weight gain by cutaneous absorption. The mechanism is probably vagal (stimulation of baroreceptors and skin mechanoreceptors) since it is found in children stimulated an increase in the vagal activity, acceleration of gastric emptying and an increase in the secretion of insulin and IGF1.

Few studies have evaluated the effects of massage on the medium-term neurological development in preterm infants and the effect of the essential oils in the effectiveness of touching the short and medium term massage.

The aim of the investigators study is to evaluate the neurological development in the short and medium term in premature newborns and biological effects of massage with essential use of vegetable oil.

Methodology and possible collaborations This is a monocentric, randomized, controlled, in a neonatal intensive care unit. It concerns 60 children born between 26 and 30 weeks of amenorrhea. Each child receives massage randomized with or without oil ISIO 4. The treatment is administered 10 minutes twice a day for 10 consecutive days watching for signs of intolerance. The quality of the spontaneous motility between 12 and 20 weeks of age corrected is used as the first neurological assessment criterion.

The questionnaire (ASQ) Bricker and Squires (translated into French by Martha Bonin et al.) is used to 6, 12, 24 months corrected age and completed by the parents as a second neurological endpoint.

A lipid chromatography is performed at the beginning and at the end of the massage time and at the deliverance from NICU for comparing the profile of children's fatty acids.

Expected results Show that there is an improvement in the neurological development in children who received massage with vegetable oil ISIO 4. Show that there is a skin absorption of essential fatty acids that can substitute for a known major deficiency in premature even in infants fed breast milk.


acronym: GANCIMVEAR

title: Evaluation of the Benefit of Antiviral Treatment With Valganciclovir on Congenital CMV Infection-related Deafness on Hearing and Balance

source: euctr

summary:
Congenital cytomegalovirus (CMV) infection is the leading cause of non-genetic neurosensory deafness and affects 0.5 to 1% of births. Twenty to thirty per cent of children will develop deafness, some of whom will progress gradually to profound bilateral deafness.

No curative treatment is currently offered for this deterioration in hearing and management involves the use of a hearing aid or cochlear implant. Many studies describe the utility of antiviral treatment on the course of the deafness. These mostly involve neonates with multi-system symptomatic forms of the infection who have been given 6 weeks of ganciclovir possibly switched to valganciclovir, which has shown benefit in stabilising auditory loss, or even improvement.


title: Peri-sphincter Injection of Autologous Myofibres to Treat of Urinary Incontinence by Sphincter Deficiency

acronym: IPSMA

summary:
Stress urinary incontinence related to intrinsic sphincter deficiency (ISD) is a severe form of incontinence that may have a major impact on the quality of life. The main treatment is surgical and consists in the implantation of medical devices such as the artificial urinary sphincter, adjustable continence therapy, compressive sling, or injection of bulking agent.

The investigator has developed a new therapeutic strategy for ISD that consist to implant myofibers with their attached satellite cells (the main source of muscle progenitor cells) at the vicinity of the striated urethral sphincter. The principle of this method relies on the in vivo activation of satellite cells leading to the formation of regenerated myofibers (myotubes) generating a distinct and tonic muscular activity . The proof of concept was investigated in a Phase I clinical trial: Investigator found that the periurethral implantation of myofiber strips around the urethra generated an electromyographic activity improving urethral closure pressure in women with severe urinary incontinence associated to ISD. In this previous study, the technique of myofiber implantation was invasive, as it required a surgical approach and dissection of the urethra to place the myofiber. For the clinical trial IPSMA, the investigator sought to optimize the myofiber transplantation process using a method injection of myofibers core obtained by hydro-dissection. The injection technique is performed percutaneously under fluoroscopic and endoscopic control and does not require a surgical approach of the urethra.

This clinical trial is prospective, open-label, non-randomized, uncontrolled, single-center for the first stage and multicenter for the second stage, of 13 months for each patient aims to assess the efficacy and safety of IPSMA in the treatment of urinary incontinence in women with ISD.

ReferenceCitation: Yiou R, Hogrel JY, Loche CM, Authier FJ, Lecorvoisier P, Jouany P, Roudot-Thoraval F, Lefaucheur JP. Periurethral skeletal myofibre implantation in patients with urinary incontinence and intrinsic sphincter deficiency: a phase I clinical trial. BJU Int. 2013 Jun;111(7):1105-16. doi: 10.1111/j.1464-410X.2012.11682.x. Epub 2013 Mar 7.


title: Feasibility Study of a Treatment Protocol of Pediatric Chemo- and Radiotherapy-induced Oral Mucositis by Low-level Laser Therapy

acronym: PEDIALASE

summary: Low Level Laser Therapy has been used for a few years in some pediatric hospital centers for chemo- and radiotherapy-induced oral mucositis care. It may promote ulceration's healing, limits mucositis severity and associated pain. As its use is recommended in the treatment of radio induced mucositis in adults, the level of evidence in pediatric studies does not allow a precise treatment protocol. The investigators present here the protocol of a feasibility study in the haemato-oncology department of the Children University Hospital of Toulouse, with the view to a future efficacy study.

ReferenceCitation: Qutob AF, Gue S, Revesz T, Logan RM, Keefe D. Prevention of oral mucositis in children receiving cancer therapy: a systematic review and evidence-based analysis. Oral Oncol. 2013 Feb;49(2):102-7. doi: 10.1016/j.oraloncology.2012.08.008. Epub 2012 Sep 7. Review.

ReferenceCitation: Sonis ST. Oral mucositis in head and neck cancer: risk, biology, and management. Am Soc Clin Oncol Educ Book. 2013. doi: 10.1200/EdBook_AM.2013.33.e236. Review.

ReferenceCitation: Glenny AM, Gibson F, Auld E, Coulson S, Clarkson JE, Craig JV, Eden OB, Khalid T, Worthington HV, Pizer B; Children's Cancer and Leukaemia Group (CCLG)/Paediatric Oncology Nurses Forum's (CCLG-PONF) Mouth Care Group. The development of evidence-based guidelines on mouth care for children, teenagers and young adults treated for cancer. Eur J Cancer. 2010 May;46(8):1399-412. doi: 10.1016/j.ejca.2010.01.023. Epub 2010 Mar 11. Review.

ReferenceCitation: Huang YY, Sharma SK, Carroll J, Hamblin MR. Biphasic dose response in low level light therapy - an update. Dose Response. 2011;9(4):602-18. doi: 10.2203/dose-response.11-009.Hamblin. Epub 2011 Sep 2.

ReferenceCitation: Bensadoun RJ, Nair RG. Low-level laser therapy in the prevention and treatment of cancer therapy-induced mucositis: 2012 state of the art based on literature review and meta-analysis. Curr Opin Oncol. 2012 Jul;24(4):363-70. doi: 10.1097/CCO.0b013e328352eaa3. Review.


title: Interest of Cytological Screening for Early Diagnosis of Precancerous or Cancerous Lesions of Oral Cavity by Transepithelial Brushing in Liquid-based

acronym: Cytobuccale

summary:
Prospective study of diagnosis validation of a cytological technique. 200 patients with oral cavity cancerous and precancerous lesions will be enrolled.

A cytological sample of the lesion will be performed by transepithelial brushing ( Orcellex® Rovers brush) in cytology liquid-based technology (methode ThinPrep 2000 (Hologic®)). A microscopic double blind reading will be performed. A biopsy sampling will be carried out in accordance with current strategy of screening. The brushing diagnosis quality will be compared to the biopsy which is the gold standard.

primary_purpose: Screening


title: " Virtual Brain "-Based Interpretation of Electrophysiological Signals in Epilepsy

acronym: VIBRATIONS

summary:
Epilepsy is a major neurological disorder, affecting of the order of 0.5 to 1% of the population. It is a very invalidating disease, with high impact on quality of life. In a large proportion of cases, medication cannot prevent seizures; surgical removal of the regions responsible for seizures is then the only way to cure patients. However, results crucially depend on the correct delineation of the epileptogenic zone.

In this context, computational modeling, under the form of a "virtual brain" is a powerful tool to investigate the impact of different configurations of the sources on the measures, in a well-controlled environment.

In this project, the simulate in a biologically realistic way MEG (Magnetoencephalography) and EEG (Electroencephalography) fields produced by different configurations of brain sources, which will differ in terms of spatial and dynamic characteristics will be offered to participants. The research hypothesis is that computational and biophysical models can bring crucial information to clinically interpret the signals measured by MEG and EEG. In particular, the hypothesis can help to efficiently address some complementary questions faced by epileptologists when analyzing electrophysiological data.

The strategy will be three-fold:

i) Construct a virtual brain models with both dynamic aspects (reproducing both hyperexcitability and hypersynchronisation alterations observed in the epileptic brain) and a realistic geometry based on actual tractography measures performed in patients ii) Explore the parameter space though large-scale simulations of source configurations, using parallel computing implemented on a computer cluster.

iii) Confront the results of these simulations to simultaneous recordings of EEG, MEG and intracerebral EEG (stereotactic EEG, stereoelectroencephalography (SEEG)). The models will be tuned on SEEG signals, and tested versus the surface signals in order to validate the ability of the models to represent real MEG and EEG signals.

The project constitutes a translational effort from theoretical neuroscience and mathematics towards clinical investigation. A first output of the project will be a database of simulations, which will permit in a given situation to assess the number of configurations that could have given rise to the observed signals in EEG, MEG and SEEG. A second - and major - output of the project will be to give the clinician access to a software platform which will allow for testing possible configurations of hyperexcitable regions in a user-friendly way. Moreover, representative examples will be made available to the community through a website, which will permit its use in future studies aimed at confronting the results of different signal processing methods on the same 'ground truth' data.

location_facility: Assistance Publique Hôpitaux de Marseille


title: 4D FLOW: Feasibility Study of a Sequence 4D of Flow Applied to the Cervico-encephalic Vascular Pathologies

summary:
The dynamic angio-MR sequences with injection of contrast (CE ARM) allow the study of the vascular anatomy. These sequences, widely used in clinical routine have shown their utility, in particular in the detection of the cerebrovascular diseases. The 4D flow MR sequences allow to quantify arterial parameters such as the speed of the circulating flow. By allowing an anatomical analysis and a functional analysis of quantitative parameters, 4D flow MR sequences could replace 1/ the currently used dynamic MRA sequences that are less precise in term of spatial and temporal resolution; 2/ the invasive exploration by DSA for the detection of vascular lesion and complete the exploration of the cervico-encephalic vascular pathologies by providing hemodynamical measures not yet accessible in clinical settings.

In this context, the aim of the study is to evaluate the feasibility and the clinical usefulness of this 4D Flow technique to image brain vascular disorders including steno occlusive disorders. The evaluation will include several steps: 1/ optimization of acquisition parameters for the cranio-cervical arteries; 2/ comparison of two strategies for the post-processing 3/ feasibility for imaging of brain vascular disorders.

lead_sponsor: Centre Hospitalier St Anne


acronym: Tgcyto

summary:
Cytological examination of punctured lymph nodes is the gold standard for confirming metastatic lymph node spread of differentiated thyroid cancers. In order to increase the diagnostic sensitivity of fine-needle cyto-punctured lymph nodes, an assessment of Tg levels of the aspirate could be included. Although this technique has been well proven, many uncertainties remain, especially with regards to a pathological cut-off value and its clinical utility when the thyroid is still intact. This uncertainty is mainly due to discordancy between low Tg levels found in cytopunctured lymph nodes with normal cytology, and their final histopathological analyses.

To eliminate this uncertainty, cyto-punction will be performed intra-operatively after localizing and isolating the target lymph nodes for assessment of cytology and Tg values. The thyroid gland might be present or absent (already operated) depending on the case. Finally, the cyto-punctured lymph nodes will be excised for complete histopathological analysis. In order to determine whether the Tg values are appropriate in cases where the thyroid is intact, a control group has been included (First operation for thyroid cancer or benign pathology). To eliminate the possible iatrogenic risks of lymph node dissection and resection in patients for whom it is not indicated, only lymph nodes found along the incision path for neuromonitoring of the recurrent laryngeal nerve (performed systematically) will be analysed and excised.


title: Prone Position Effects on Work of Breathing and Intrinsic PEEP in Children With Severe Acute Viral Bronchiolitis

acronym: BRONCHIO-DV

summary: Acute viral bronchiolitis is the first cause of respiratory distress in infant. Airway inflammation increases the respiratory system resistances and dynamic hyperinflation. This leads to an increase in the work of breathing. In Chronic obstructive pulmonary disease patients as in neonates, prone position (PP) improves lung function and decreases the end expiratory lung volume. The investigators hypothesized that in infants with severe bronchiolitis, prone position reduces the intrinsic Positive End Expiratory Pressure (PEEPi) and the work of breathing (WOB). The investigator designed a prospective randomized crossover study with 16 infants younger than six months who need ventilatory support by nasal continuous positive airway pressure (nCPAP) for severe acute viral bronchiolitis. Work of breathing (product time pressure) and PEEPi will be estimated using an esophageal pressure probe in prone and supine position.

ReferenceCitation: Baudin F, Emeriaud G, Essouri S, Beck J, Portefaix A, Javouhey E, Guerin C. Physiological Effect of Prone Position in Children with Severe Bronchiolitis: A Randomized Cross-Over Study (BRONCHIO-DV). J Pediatr. 2019 Feb;205:112-119.e4. doi: 10.1016/j.jpeds.2018.09.066. Epub 2018 Nov 14.

lead_sponsor: Hospices Civils de Lyon


title: Study of Dendrogenin A / Oxysterols Balance Between Healthy Volunteers and Acute Myeloid Leukemia Patients. Modulations of the Balance During Cytarabine/Anthracycline Treatment - OxyLAM

acronym: OXYLAM

summary: Dendrogenin A is present in mammals normal tissues and fluids, notably blood. It is down-represented or absent in cancer cell lines and tumors. In the opposite, OCDO is accumulated in cancerous conditions and virtually absent of normal tissues. This study will try to determine modulations of these oxysterols and protein involved in their metabolism between Acute myeloid leukemia (AML) patient samples and normal blood or marrow, for evaluation of these markers as companion biomarkers for Dendrogenin A treatment.


title: Multicenter Pilot Study to Describe the Performance of a New Device in Patients With Colostomy

summary: The study evaluates the efficacy of a new 2-piece appliance in patients with colostomy.

lead_sponsor: BBraun Medical SAS


title: PET-based Evaluation of Chemotherapy-induced Brain Damage in Lymphoma Patients -Implication in the Evaluation of Neuro-cognitive Function Alteration (LYMCOTEP)

acronym: LYMCOTEP

summary: Positron emission tomography (PET) with 18-fluoro-deoxy-glucose (PET-FDG) is emerging as a promising approach for detecting brain lesions in dementia, among which Alzheimer's disease has been the most widely studied.


title: Assessment of Breast Cancer Response to Neoadjuvant Anthracycline-based Chemotherapy by Fluorodeoxyglucose Positron Emission Tomography (FDG-PET) and Molecular Markers

summary:
A correlation between early changes in the tumor maximum standardized uptake value (SUVmax) on FDG-PET after one or two cycles of neoadjuvant chemotherapy (NAC) and the pathological response after 6 to 8 cycles has been demonstrated in several independent small series of patients.

Breast tumor proliferation status has previously been demonstrated to be a good predictive factor of response to chemotherapy. The best method for assessing proliferation status is unclear. Proportion of cells staining for nuclear Ki67 antigen is the most widely used assay for comparing the proliferation status between tumors. However major variations in analytical procedure and interpretation limited its clinical value. Taking into account the prognosis and predictive value of proliferation gene as a common "signature" in breast cancer transcriptome analysis, quantitative assessment of mRNA expression of genes involved in proliferation has been developed by the investigators team and others. The evaluation of these parameters is quantitative and reliable and can be standardized for a clinical use.

The main objective of the investigators study is to early predict pathological response to anthracycline-based neoadjuvant chemotherapy (NAC) using a combination of parameters based on FDG-PET imaging performed at baseline and after 2 cycles, and molecular markers of proliferation measured on pre-treatment biopsy (Ki67 protein level by immunohistochemistry and Ki67 mRNA level and the mRNA (messenger RNA) expression of the most pertinent genes of the Genomic Grade Index (GGI) component by RT (reverse transcriptase) - qPCR).

lead_sponsor: Assistance Publique - Hôpitaux de Paris


title: Improvement of Team Performance With a Pre-critical Staff Within the Team Prior to Admission of Critical Simulated Patient in High Fidelity Simulation Session for Anesthesiology Resident During Their Education Curriculum

acronym: Simstaf&perf

summary: Simulated environment allowed safe learning of critical events and knowledge of appropriate response and treatment. Anesthesiology resident education curriculum in Lyon plans several high fidelity simulation session with a large panel of critical events. Anticipation of critical events before they may occur and plannification of team resources and priority in the treatment strategy may help to improve team performance during the scenario. The investigators' goal is to compare team performance during the scenario with or without a liberal preparation team staff of 4 min, suggested after the briefing of the scenario but before the scenario starts.

lead_sponsor: Claude Bernard University

intervention_type: Behavioral


title: Measured FiO2 With Nasal Canula O2 Versus Noninvasive Ventilation (NIV) With the Same O2 Flow, in COPD Patients the NIV LEAKS Study

acronym: NIVLEAKS

summary: The purpose of this study is to compare pharyngeal FiO2 in day time with nasal normobaric O2 with inhaled FiO2 in the night time with home care ventilator NIV at the same O2 flow.

ReferenceCitation: Cardinale M, Cungi PJ, Esnault P, Castagna O, Nguyen C, Daranda E, Bordes J, Arnal JM, Meaudre E, Goutorbe P. In COPD, Nocturnal Noninvasive Ventilation Reduces the FIO2 Delivered Compared With Long-Term Oxygen Therapy at the Same Flow. Respir Care. 2020 Dec;65(12):1897-1903. doi: 10.4187/respcare.07570. Epub 2020 Jul 21.

lead_sponsor: Breas Medical S.A.R.L.


title: Characterization of Post-operative Pain Trajectories Over Seven Days and Their Potential Links With Chronicity After 3 Months: a Single-center, Prospective, Pilot Cohort Study at the Nîmes University Hospital

acronym: PATCH

summary: The main objective of this study is to establish the postoperative "pain pathways" observed from D1 to D7 in the context of the current management after orthopedic, digestive, obstetrics and gynecology, urology, neurosurgery, vascular and thoracicn surgeries.

ReferenceCitation: Bouhassira D, Attal N, Alchaar H, Boureau F, Brochet B, Bruxelle J, Cunin G, Fermanian J, Ginies P, Grun-Overdyking A, Jafari-Schluep H, Lantéri-Minet M, Laurent B, Mick G, Serrie A, Valade D, Vicaut E. Comparison of pain syndromes associated with nervous or somatic lesions and development of a new neuropathic pain diagnostic questionnaire (DN4). Pain. 2005 Mar;114(1-2):29-36. Epub 2005 Jan 26.

ReferenceCitation: Sullivan, M. J., Bishop, S. R., & Pivik, J. The pain catastrophizing scale: development and validation. Psychological assessment, 1995, 7(4), 524.

ReferenceCitation: L'Hermite J, Pagé MG, Chevallier T, Occean B, Viel E, Bredeau O, Lefrant JY, Cuvillon P. Characterisation of pragmatic postoperative PAin Trajectories over seven days and their association with CHronicity after 3 months: a prospective, pilot cohort study (PATCH study). Anaesth Crit Care Pain Med. 2021 Feb;40(1):100793. doi: 10.1016/j.accpm.2020.100793. Epub 2020 Dec 23.


title: Randomized, Double Blind, Placebo-controlled Study of the Safety, Tolerability and Pharmacokinetics After Single Ascending Doses or Multiple Ascending Doses of OSCN-, bLF or ALX-009 in Healthy Male and CF and Non-CF Bronchiectasis Patients

summary: This is a Phase 1, randomized, double-blind, placebo-controlled study to evaluate the safety, tolerability and pharmacokinetics of a single ascending doses (SAD) and multiple ascending doses (MAD) of Hypothiocyanite (OSCN-), bovine lactoferrin (bLF) and their combination (ALX-009) in healthy male volunteers and patients suffering from cystic fibrosis (CF) and non-CF bronchiectasis (NCFBE).

lead_sponsor: Alaxia SAS


title: Evaluation of the Effectiveness of Self Management Program on Changes in Physical Activity Level of Knee Osteoarthritis Patients in Spa Therapy

acronym: GEET One

summary: The primary purpose is to evaluate the benefit of an education action of exercise on the level of physical activity in patients with knee osteoarthritis with the waning of a spa treatment for three weeks, three months after the start of the cure.

ReferenceCitation: Gay C, Guiguet-Auclair C, Pereira B, Goldstein A, Bareyre L, Coste N, Coudeyre E. Efficacy of self-management exercise program with spa therapy for behavioral management of knee osteoarthritis: research protocol for a quasi-randomized controlled trial (GEET one). BMC Complement Altern Med. 2018 Oct 16;18(1):279. doi: 10.1186/s12906-018-2339-x.

lead_sponsor: University Hospital, Clermont-Ferrand


title: Premature Labour Screening by Cervical Ultrasound for Asymptomatic Pregnant Women in the PACA Region. Various Treatment Strategies : 1. Progesterone 200mg (Vaginal Way) 2. Pessary 3. Vaginal Stitching 4. Rest

acronym: Echo-col

summary:
State of the question and research objective: International trials have shown that ultrasound measurement of the cervix identifies a population at high risk of preterm delivery. In case of short neck several types of treatments can be recommended: progesterone, the establishment of a strapping or pessary. These three treatments reduce the risk of preterm delivery. There is no French study.

The objective of this study is to reduce prematurity in the PACA region Monaco-Corsica by introducing a routine ultrasound screening strategy asymptomatic short necks.

Population concerned: All patients with active singleton pregnancy between 16 and 26 SA SA are eligible to ultrasound of the cervix.

Primary endpoint: delivery rate before 37 weeks.
Criteria secondary judgments rate of deliveries before 37 weeks, neonatal mortality morbidity.

Expected result: a prematurity of 50%

ReferenceCitation: Figarella A, Chau C, Loundou A, d'Ercole C, Bretelle F. The introduction of a universal transvaginal cervical length screening program is associated with a reduced preterm birth rate. Am J Obstet Gynecol. 2022 Aug 4. pii: S0002-9378(22)00614-7. doi: 10.1016/j.ajog.2022.07.046. [Epub ahead of print]


title: Evaluation of the Metrological Characteristics of the Inertial Unit FOX HiKoB© in Comparison With the Reference System for the Adaptive Trigger System "Functional Electrical Stimulation" of Foot Elevators in Hemiplegic Post-stroke Patients

acronym: MASEA 2

summary: The main objective of this study is to evaluate the metrological characteristics of the data processing algorithms from inertial sensors (FOX © HiKoB) for the reconstruction of movement relative to the reference system (VICON) for measurement of dorsiflexion at the beginning of a step and in the middle of the oscillating phase.

lead_sponsor: Centre Hospitalier Universitaire de Nīmes


title: Comparative Evaluation of Two Techniques for the Treatment of Per-operative Bacteriological Samples Associated With Osteo-articular Sepsis: Grinding (Ultra Turrax) Versus Standard Methods

acronym: IOAP Turrax

summary: The main objective of this study was to compare the diagnostic capability (sensitivity and specificity) of standard bacteriological analysis made from one or other of the two sampling processing techniques and perioperative management of samples : the Ultra Turrax method that uses grinding versus the standard method.


title: Evaluation of Post-voiding Residual Urine: a Before-after, Post-partum Study

acronym: RPM-Eval

summary: The primary objective of this study is to evaluate the impact of systematic catheter-drainage of urine for parturient women immediately in the delivery room on the occurrence of post-voiding urine residue.


title: Exploration du système Des Neurones-miroirs Par Enregistrement EEG du Rythme mu Chez l'Enfant Atteint de lésion cérébrale unilatérale Lors d'Action, d'Observation et d'Imagination d'Action du Membre supérieur. " Action-Observation-EEG "

acronym: AOE

summary: To study the reactivity of the mu rhythm during action and action-observation by EEG in children with unilateral cerebral injury.

lead_sponsor: University Hospital, Angers