title: Contribution of Learning and Practice of Different Complementary Therapies in Pulmonary Transplant Patients

acronym: TOOLBOX

summary: The aim of the study is to evaluate, 3 months after lung transplantation, integration and appropriation by the patient of complementary techniques (" Toolbox " included relaxation, autohypnosis, relaxation therapy, TENS (if pain) and holistic gymnastics to improve the comfort and the quality of life in very high-technology care pathway

ReferenceCitation: Ringsted TK, Wildgaard K, Kreiner S, Kehlet H. Pain-related impairment of daily activities after thoracic surgery: a questionnaire validation. Clin J Pain. 2013 Sep;29(9):791-9. doi: 10.1097/AJP.0b013e318278d4e2.

ReferenceCitation: Bouhassira D, Lantéri-Minet M, Attal N, Laurent B, Touboul C. Prevalence of chronic pain with neuropathic characteristics in the general population. Pain. 2008 Jun;136(3):380-387. doi: 10.1016/j.pain.2007.08.013. Epub 2007 Sep 20.

ReferenceCitation: Lépine JP, Godchau M, Brun P, Lempérière T. [Evaluation of anxiety and depression among patients hospitalized on an internal medicine service]. Ann Med Psychol (Paris). 1985 Feb;143(2):175-89. French.

ReferenceCitation: Lesage FX, Berjot S, Deschamps F. Psychometric properties of the French versions of the Perceived Stress Scale. Int J Occup Med Environ Health. 2012 Jun;25(2):178-84. doi: 10.2478/S13382-012-0024-8. Epub 2012 Apr 19.

ReferenceCitation: Spiegel R. Sleep and sleeplessness in advanced age. Advances in Sleep Research. Lancaster UK: MTP Press; 1981. p. 1-272.

ReferenceCitation: Michel-Cherqui M, Ley L, Szekely B, Dreyfus JF, Fischler M. Prevalence and characteristics of pain in patients awaiting lung transplantation. J Pain Symptom Manage. 2015 Mar;49(3):548-54. doi: 10.1016/j.jpainsymman.2014.07.011. Epub 2014 Aug 21.

ReferenceCitation: Wildgaard K, Iversen M, Kehlet H. Chronic pain after lung transplantation: a nationwide study. Clin J Pain. 2010 Mar-Apr;26(3):217-22. doi: 10.1097/AJP.0b013e3181b705e4.

ReferenceCitation: Girard F, Chouinard P, Boudreault D, Poirier C, Richard C, Ruel M, Ferraro P. Prevalence and impact of pain on the quality of life of lung transplant recipients: a prospective observational study. Chest. 2006 Nov;130(5):1535-40.

ReferenceCitation: Gross CR, Kreitzer MJ, Thomas W, Reilly-Spong M, Cramer-Bornemann M, Nyman JA, Frazier P, Ibrahim HN. Mindfulness-based stress reduction for solid organ transplant recipients: a randomized controlled trial. Altern Ther Health Med. 2010 Sep-Oct;16(5):30-8.

ReferenceCitation: Goldbeck L, Fidika A, Herle M, Quittner AL. Psychological interventions for individuals with cystic fibrosis and their families. Cochrane Database Syst Rev. 2014 Jun 18;(6):CD003148. doi: 10.1002/14651858.CD003148.pub3. Review.

ReferenceCitation: 13. Servant D. La relaxation, nouvelles approches nouvelles pratiques: Elsevier-Masson; 2009.

ReferenceCitation: McCraty R, Zayas MA. Cardiac coherence, self-regulation, autonomic stability, and psychosocial well-being. Front Psychol. 2014 Sep 29;5:1090. doi: 10.3389/fpsyg.2014.01090. eCollection 2014.

ReferenceCitation: Sarabia-Cobo CM. Heart coherence: a new tool in the management of stress on professionals and family caregivers of patients with dementia. Appl Psychophysiol Biofeedback. 2015 Jun;40(2):75-83. doi: 10.1007/s10484-015-9276-y.

ReferenceCitation: Anbar RD. Self-hypnosis for patients with cystic fibrosis. Pediatr Pulmonol. 2000 Dec;30(6):461-5.

ReferenceCitation: Jensen MP. Hypnosis for chronic pain management: a new hope. Pain. 2009 Dec;146(3):235-237. doi: 10.1016/j.pain.2009.06.027. Epub 2009 Jul 10.

ReferenceCitation: Tefikow S, Barth J, Maichrowitz S, Beelmann A, Strauss B, Rosendahl J. Efficacy of hypnosis in adults undergoing surgery or medical procedures: a meta-analysis of randomized controlled trials. Clin Psychol Rev. 2013 Jul;33(5):623-36. doi: 10.1016/j.cpr.2013.03.005. Epub 2013 Mar 26.

ReferenceCitation: Carroll D, Moore RA, McQuay HJ, Fairman F, Tramèr M, Leijon G. Transcutaneous electrical nerve stimulation (TENS) for chronic pain. Cochrane Database Syst Rev. 2001;(3):CD003222. Review. Update in: Cochrane Database Syst Rev. 2008;(3):CD003222.

ReferenceCitation: Bjordal JM, Johnson MI, Ljunggreen AE. Transcutaneous electrical nerve stimulation (TENS) can reduce postoperative analgesic consumption. A meta-analysis with assessment of optimal treatment parameters for postoperative pain. Eur J Pain. 2003;7(2):181-8.

ReferenceCitation: 21. Michel-Cherqui M. Effect of TENS (TransCutaneous Electrical NeuroStimulation) on post lung transplantation pain. 11th International Congress on Lung Transplantation Paris; 2014.


title: Performance in Walking in Osteoarthritis Patients: the Role of Fatigue and the Effect of an Eccentric Muscle Building Program

acronym: EX-ART

summary: Few data exist to date on the effect of eccentric muscle building in knee osteoarthritis. No studies have compared the effect of eccentric versus concentric reinforcement in knee osteoarthritis. Our study aims to show the effectiveness of an eccentric reinforcement. This is a randomized, interventional trial.

study_start_date_type: Actual

status: Unknown status

study_completion_date_type: Anticipated

study_type: Interventional

design_allocation: Randomized

primary_purpose: Other

enrollment_type: Anticipated

ipd_sharing: Undecided

lead_sponsor: Centre Hospitalier Universitaire de Nice

location_facility: Department of rheumatology, nice university hospital

intervention_type: Other

lead_sponsor_type: academique

status_simplified: Unknown


type: Other Identifier

title: Survey on the Place of Community Pharmacists in the Detection of Cannabis Use: a Student's Point of View

acronym: CANNACY

summary: The objective of this survey will be to evaluate the perception by the students (except for medical students, pharmacies) of community pharmacists concerning the management of cannabis consumption. We want to see if the student population perceives the pharmacist as the public health actor of choice, and if they would more easily turn to him or to another health professional (doctor, nurse) in case they need. Discussing possible problematic consumption or for a simple search for information. It will be assessed whether the pharmacist seems to be a good candidate and an element of choice when young adults want to take an intelligence approach to cannabis consumption.

status: Completed

study_completion_date_type: Actual

study_type: Observational

time_perspective: Prospective

enrollment_type: Actual

lead_sponsor: University Hospital, Clermont-Ferrand

status_simplified: Completed


title: Comparative Effectiveness Clinical Early of Transvaginal and Laparoscopic Approaches for Drainage of Tubo -Ovarian Abscess. Randomized Noninferiority

acronym: DTOA

summary:
The treatment of the acute phase of the complicated abscess tubo-ovarian relies on antibiotics more or less associated with surgical management in case of visible abscess, poor clinical tolerance (sepsis) and resistance to medical treatment. The CNGOF recommended in 2012 that the tubo-ovarian abscess are not within one antibiotic, and should be drained by interventional radiology, preferably by transvaginal or laparoscopic.

Furthermore the efficiency of drainage by ultrasound puncture performed vaginally was demonstrated. This approach tends to replace the first laparoscopy because of its less invasive, fast, easy to access, more acceptable and less cost compared to laparoscopy. This approach is recommended by the French and English colleges.

In total, the surgery in case of ATO is necessary, it is always coupled with antibiotics. Several surgical approaches are possible, laparotomy, laparoscopy and ultrasound-guided puncture. No prospective comparative study has been done, for which we want to develop this study.

primary_purpose: Treatment

ReferenceType: background

ReferenceCitation: Gjelland K, Ekerhovd E, Granberg S. Transvaginal ultrasound-guided aspiration for treatment of tubo-ovarian abscess: a study of 302 cases. Am J Obstet Gynecol. 2005 Oct;193(4):1323-30.

ReferenceCitation: Granberg S, Gjelland K, Ekerhovd E. The management of pelvic abscess. Best Pract Res Clin Obstet Gynaecol. 2009 Oct;23(5):667-78. doi: 10.1016/j.bpobgyn.2009.01.010. Epub 2009 Feb 20. Review.

ReferenceCitation: Gerber B, Krause A. A study of second-look laparoscopy after acute salpingitis. Arch Gynecol Obstet. 1996;258(4):193-200.

ReferenceCitation: Le Bouëdec G, Pouly JL, Canis M, Wattiez A, Abbas B, Mage G, Bruhat MA. [Acute salpingitis. Celioscopy before and after treatment: 110 cases]. J Gynecol Obstet Biol Reprod (Paris). 1991;20(5):680-4. French.

ReferenceCitation: Raiga J, Canis M, Le Bouëdec G, Glowaczower E, Pouly JL, Mage G, Bruhat MA. Laparoscopic management of adnexal abscesses: consequences for fertility. Fertil Steril. 1996 Nov;66(5):712-7.

ReferenceCitation: Heinonen PK, Leinonen M. Fecundity and morbidity following acute pelvic inflammatory disease treated with doxycycline and metronidazole. Arch Gynecol Obstet. 2003 Oct;268(4):284-8. Epub 2002 Oct 26.

ReferenceCitation: Trent M, Bass D, Ness RB, Haggerty C. Recurrent PID, subsequent STI, and reproductive health outcomes: findings from the PID evaluation and clinical health (PEACH) study. Sex Transm Dis. 2011 Sep;38(9):879-81. doi: 10.1097/OLQ.0b013e31821f918c.

ReferenceCitation: Ness RB, Soper DE, Holley RL, Peipert J, Randall H, Sweet RL, Sondheimer SJ, Hendrix SL, Amortegui A, Trucco G, Songer T, Lave JR, Hillier SL, Bass DC, Kelsey SF. Effectiveness of inpatient and outpatient treatment strategies for women with pelvic inflammatory disease: results from the Pelvic Inflammatory Disease Evaluation and Clinical Health (PEACH) Randomized Trial. Am J Obstet Gynecol. 2002 May;186(5):929-37.

ReferenceCitation: Abbitt PL, Goldwag S, Urbanski S. Endovaginal sonography for guidance in draining pelvic fluid collections. AJR Am J Roentgenol. 1990 Apr;154(4):849-50.

ReferenceCitation: Buchweitz O, Malik E, Kressin P, Meyhoefer-Malik A, Diedrich K. Laparoscopic management of tubo-ovarian abscesses: retrospective analysis of 60 cases. Surg Endosc. 2000 Oct;14(10):948-50.

ReferenceCitation: Henry-Suchet J, Soler A, Loffredo V. Laparoscopic treatment of tuboovarian abscesses. J Reprod Med. 1984 Aug;29(8):579-82.

ReferenceCitation: Garbin O, Verdon R, Fauconnier A. [Treatment of the tubo-ovarian abscesses]. J Gynecol Obstet Biol Reprod (Paris). 2012 Dec;41(8):875-85. doi: 10.1016/j.jgyn.2012.09.012. Epub 2012 Nov 10. Review. French.

ReferenceCitation: Perez-Medina T, Huertas MA, Bajo JM. Early ultrasound-guided transvaginal drainage of tubo-ovarian abscesses: a randomized study. Ultrasound Obstet Gynecol. 1996 Jun;7(6):435-8.

ReferenceCitation: Vermersch C, Dessein R, Lucot JP, Rubod C, Cosson M, Giraudet G. [Tubo-ovarian abscesses treatment: Faisability and results of trans-vaginal ultrasound-guided aspiration]. J Gynecol Obstet Biol Reprod (Paris). 2016 Mar;45(3):243-8. doi: 10.1016/j.jgyn.2015.04.016. Epub 2015 Jun 19. French.

intervention_type: Procedure


summary:
Retrospective study, single-center, on 171 patients, presented a cryptogenic TIA and Minor stroke.

This study objective is to determine profitability of Holter 21 days for screening paroxystic ACFA / flutter in cryptogenic TIA/Minor stroke, and identify the predictive factors of discovery a paroxystic ACFA on Holter 21 days. Clinical and échocardiographics factors, and brain imaging (scanner and MRI) will be analyzed.

primary_purpose: Prevention

ReferenceType: result

ReferenceCitation: Sudacevschi V, Bertrand C, Chadenat ML, Tarnaud C, Pico F. Predictors of Occult Atrial Fibrillation in One Hundred Seventy-One Patients with Cryptogenic Transient Ischemic Attack and Minor Stroke. J Stroke Cerebrovasc Dis. 2016 Nov;25(11):2673-2677. doi: 10.1016/j.jstrokecerebrovasdis.2016.07.014. Epub 2016 Aug 2.

family: Sudacevschi

full_name: Veronica Sudacevschi

given: Veronica

sequence: first

family: Bertrand

full_name: Cathy Bertrand

given: Cathy

sequence: additional

family: Chadenat

full_name: Marie L. Chadenat

given: Marie L.

family: Tarnaud

full_name: Chloé Tarnaud

given: Chloé

family: Pico

full_name: Fernando Pico

given: Fernando

bso_classification: Medical research

datasource: user

genre: journal-article

genre_raw: journal-article

journal_name: Journal of Stroke and Cerebrovascular Diseases

publisher: Elsevier BV

publisher_dissemination: Elsevier

publisher_group: Elsevier

publisher_normalized: Elsevier

ipd_sharing: No

lead_sponsor: Versailles Hospital


title: Individualized Goal-directed Sufentanil Administration Versus Standard Therapy in Patients Undergoing Major Abdominal Surgery: A Randomized Controlled Feasibility Trial.

acronym: PHOENIX

summary: To determine whether a treatment strategy targeting an individualized sufentanil administration based on the Analgesia Nociception Index (ANI) could reduce the total dose of sufentanil during major abdominal surgery, as compared with standard practice.

intervention_type: Device


type: EudraCT Number

title: MAINtenance of Remission With RITuximab Versus Azathioprine for Patients With Newly-diagnosed or Relapsing Eosinophilic Granulomatosis With Polyangiitis. A Prospective, Randomized, Controlled, Double-blind Study: the MAINRITSEG Trial

acronym: MAINRITSEG

summary: The purpose of this study is to investigate, after achievement of remission, the efficacy of rituximab compared with azathioprine maintenance therapy on duration of remission, in patients with relapsing or newly-diagnosed Eosinophilic granulomatosis with polyangiitis EPGA receiving standard of care therapy including glucocorticoid therapy reduction/withdrawal.

status: Recruiting

lead_sponsor: Assistance Publique - Hôpitaux de Paris

intervention_type: Drug

status_simplified: Ongoing


lead_sponsor: Assistance Publique Hopitaux De Marseille

acronym: AMIPREP

location_facility: Assisatnce Publique Hopitaux de Marseille

source: euctr

title: EVALUATION OF AN INNOVATIVE TREATMENT FOR RADIOCARPAL OSTEOARTHRITIS USING INTRA-ARTICULAR INJECTION OF A MIXTURE OF AUTOLOGOUS MICROFAT AND AUTOLOGOUS PLATELET-RICH PLASMA

summary:
Recently, the emergence of biotherapies has allowed the use of intra-articular injections of autologous plasma rich platelet (PRP). Their use is widespread since 2010 and is based on the demonstration that platelets-enriched plasma, by virtue of its growth factors concentration, stimulates in vitro and in vivo cartilage regeneration in preclinical models. Recent literature highlights that these autologous products are very well tolerated by humans. PRP, as an intra-articular injection therapy, seems to be an autologous biological medicine, innovative for cartilage injury reparation and showing good primary results for this indication.

Adipose tissue contains stromal-vascular fraction (SVF), in which are located a large proportion of mesenchymal multipotent stem cells (Adipose-derived stem cells, ADSCs) able to differentiate into several cellular lines in vitro and in vivo, including cartilage cells.

The association of microfat and PRP is interesting in order to potentiate trophic and regenerative effects on damaged cartilage site. The combination of these two products, respectively rich in autologous multipotent stem cells and growth factors, aims to create an optimal environment for cartilage cells regeneration. Furthermore, microfat semi solid phase is playing the role of a nutritive support matrix which contains and limits the diffusion and resorption of PRP liquid while allowing progressive growth factors release on the injection site.

The hypothesis of this project is that standardized injection of an innovative treatment (microfat and autologous PRP) should allow delay the use of invasive surgical therapy in the treatment of wrist osteoarthritis. This minimally invasive treatment could provide a curative second line treatment in case of medical treatment failure.


title: Impact of Early Lactate Dosage Compared to CK for Diagnosis of a Suspected Seizure, on Patient Admitted to an Emergency Unit

summary:
Defining the origin of a seizure remains a difficult diagnosis. The presence of witness is not systematic, the clinical examination can be little contributory, and the delay recommended by the FSN is often surpassed for the realization of Creatine kinase (4h). In the event of a suspected seizure, an initial blood test with Creatine kinase and Lactates is often done on admission of the patient in other words before the 4hours delay.

It seems interesting to harmonize the practices, to limit the patient wait in the emergencies for a deferred dosage of CK at 4 hours from the seizure and to identify an early biological marker.

Objectives:

To evaluate the value of blood CK and Lactate dosage in emergency procedures in the diagnosis of generalized seizures.

intervention_type: Diagnostic Test


title: Evaluation of Stroop Effect in Patients With Schizophrenia

acronym: STROOP

summary: The main objective of this study is to assess whether attention deficits and executive functions in patients with schizophrenia are general (semantic and response conflict) or specific (semantic or response conflict).

design_allocation: Non-Randomized

intervention_type: Behavioral


title: Comparison of Ultrasound-guided Central Venous Catherterization Via the Lower Internal Jugular Vein or the Subclavian Vein

acronym: JI vs SC

summary: The aim of this pilot study is to establish the success rate of catheterization of the lower jugular vein and the subclavian vein under ultrasound guidance in real time. The purpose is to compare the two techniques and to determine the best design for a full study (superiority, non-inferiority). This is a 2-arm randomized control study. The randomization ensures the comparability of the groups and allows evaluation of the feasibility and potential bias for further comparative studies.

lead_sponsor: Centre Hospitalier Universitaire de Nīmes


title: Methodical Search of Protective Factors During Interview of Suicidal Elderly Patients: Effect on the Proposed Care

acronym: ProFAES

summary:
Suicidal intentionality is generally stronger among the elderly, suicidal acts are more violent and are combined with a greater physical fragility. The suicide of an older adult is a situation that often leads to helplessness feelings.

Analysis of the literature reveals two types of major interventions in order to reduce suicide rate: reducing risk factors and increasing protective factors. Risk factors are well documented, particularly from studies using psychological autopsies. However, protective factors are much less studied for the elderly. Yet the identification of relevant and available protective mechanisms in a suicidal crisis is essential to effectively guide nurses and health professionals in therapeutic commitment and intervention.

status: Terminated

time_perspective: Cross-Sectional

ReferenceCitation: Richard-Devantoy S, Jollant F. [Suicide in the elderly: age-related specificities?]. Sante Ment Que. 2012 Autumn;37(2):151-73. French.

ReferenceCitation: Conwell Y, Thompson C. Suicidal behavior in elders. Psychiatr Clin North Am. 2008 Jun;31(2):333-56. doi: 10.1016/j.psc.2008.01.004. Review.

ReferenceCitation: Casadebaig F, Ruffin D, Philippe A. [Suicide in the elderly at home and in retirement homes in France]. Rev Epidemiol Sante Publique. 2003 Feb;51(1 Pt 1):55-64. French.

lead_sponsor: Groupe Hospitalier de la Rochelle Ré Aunis


title: Assessment of Occupational Stress and Well-being in French Patients Suffering From Bipolar Disorder

summary:
Bipolar disorder is a mental disorder characterized by alternance of depressive and manic phases, separated by intercritical phases (euthymia). The majority of patients report occupation and professional difficulties. Sixty percent of bipolar patients are inactive . Indeed, according to the World Health Organisation, bipolar disorder is the second cause of days not worked.

Several factors are related to the lower professional functioning observed in bipolar patients: early age of onset, delay of diagnosis and treatment, recurrence of thymic episodes, residual symptoms and cognitive disorders during euthymia, side effects of mood stabilizers.

To our knowledge, no study has ever focused on well-being at work in French patients. However, suffering from a psychiatric disorder and the lack of support from colleagues and the hierarchy are risk factors for burnout, a growing health issue.

Patients with mental illness are often victims of stigmatization, which may involve the professional field. In addition, thymic recurrences may alter professional functioning of active patients: multiplication of work disruptions, conflicts with peers. Conversely work can be stressful, promoting thyic relapses. It is therefore essential to better understand the occupational stresses of active patients suffering from bipolar disorder in order to promote functional remission beyond clinical remission.

The aim of this study is to assess the level of stress and well-being at work in active French bipolar patients.

time_perspective: Retrospective

ipd_sharing_description: NC

lead_sponsor: University Hospital, Montpellier


title: Evaluation of the Adult Height Gain With Growth Hormone Treatment in Children With Congenital Adrenal Hyperplasia (CDAH), Using the OPALE Prediction Model

acronym: OPALE GH

summary:
Congenital adrenal hyperplasia (CAH) is a genetic rare disease, which alters the adrenal production of gluco and mineralo corticoids. The treatment consists in supplementing children using hydrocortisone. Despite care for these children has improve substantially across decades, short adult height still remains an important consequence of the disease. About 20 % of patients have an AH below 2 standard deviations compared to their expected height.

In the OPALE model study, the investigators have collected data from a cohort of 496 French patients, born between 1970 and 1991 and with a known genotype. Using their age, sex, growth, disease, bone maturation and pubertal data, they have built a model which allows to predict their AH using data available at 8 years of age. This model has shown that the currently used formula to calculate the predicted AH (Bayley Pineau's method) is not applicable to children with CAH.

In this project, the investigators plan to use the prediction model to compare the AH in patients who have received GH treatment to their predicted AH using the model.

The hypothesis is that GH improves the AH in such patients. Existing cohorts have shown improved growth celerity, and growth expectation using the Bayley-Pineau formula), but this has not been shown on the actual AH.

This study will allow to reinforce the investigators' hypothesis.

lead_sponsor: Hospices Civils de Lyon


title: An Adult Height Prediction Model for Congenital Adrenal Hyperplasia From a National Cohort (OPALE Model Study)

acronym: OPALE Model

summary:
Congenital Adrenal Hyperplasia (CAH) is a genetic rare disease, which alters the adrenal production of gluco and mineralo corticoïds. The treatment consists in supplementing children with hydrocortisone. Despite care for these children has improved substantially across decades, short adult height (AH) still remains an important consequence of the disease. About 20% of patients have an AH below 2 standard deviations compared to their expected AH.

In the OPALE-Model study, the investigators want to collect data from a cohort of 496 CAH French patients, born between 1970 and 1991 with a known genotype. Using their age, sex, growth, disease, bone maturation and pubertal data, the investigators will build a model which allows to predict their AH using data available at 8 years of age. The growth charts built from this cohort have shown that currently used formula to calculate the predicted AH (Bayley-Pineau's formula) is not applicable to children with CAH.

In this project, the investigators plan to compute an AH prediction model using data from children born between 1970 and 1993, and to validate the model using data from a different cohort (i.e. children born between 1994 and 1998). this choice was due to availability of data for computing the model first, and in a second stage, data from more recently born patients.

ReferenceCitation: Bretones P, Riche B, Pichot E, David M, Roy P, Tardy V, Kassai B, Gaillard S, Bernoux D, Morel Y, Chatelain P, Nicolino M, Cornu C; French Collaborative CAH Growth Study Group. Growth curves for congenital adrenal hyperplasia from a national retrospective cohort. J Pediatr Endocrinol Metab. 2016 Dec 1;29(12):1379-1388. doi: 10.1515/jpem-2016-0156.


title: Influence of Medical and Nursing Teams Composition on Patient Mortality in Intensive Care

acronym: TEAMIC

summary: The individual characteristics and interactions of health care workers in intensive care units may influence patient safety. This study aims to quantify the influence of team familiarity among the members of medical and nursing staffs on risk of patient death.

study_start_date_type: Anticipated

location_facility: Service de Réanimation médicale, Hôpital de la Croix Rousse


title: Specificities of Cushing's Osteoporosis Compare to Postmenopausal Osteoporosis : pQCT Analysis in Comparison With a Group of Controls.

acronym: SOCS

summary:
Osteoporosis induced by glucocorticoids excess constitutes the main cause of secondary osteoporosis. Most of data available are provided from cohort studies of patients treated by corticosteroids, affecting among 1% of population. In contrast, very few data on osteoporosis are available in the Cushing syndrome (CS), a rare disease affecting 1 or 2 million of inhabitants, and characterized by an endogen glucocorticoid excess production. This affection is responsable of frequent fractures, occuring in 30-60% of patients (vertebral asymptomatic in 50% of case, hip, ribs). Fractures occurs often frequently above the threshold usually used for osteoporosis (T-score<-2.5), most often in the range of osteopenia. These data suggest that surface bone density isn't sufficient to characterize bone fragility, architectural factors are probably involved, and should be evaluated. The specificity of osteoporosis induced by endogen glucocorticoids excess in comparison with osteoporosis induced by estrogenic deficiency in post-menopausal women is poorly known, especially in endogen glucocorticoid excess.

A recent microarchitecture studies showed alterations of cortical compartment in patients with Cushing's syndrome, confirming by our preliminary preclinical data from a transgenic murin model of Cushing's syndrome.

In these ten last years, new radiologic tools have been developped, and are able to evaluate bone architecture. The peripheral Quantitative Computed analyses the bone architecture with distinction between cortical and trabecular compartment.

Therefore, we aim to determine the specificity of osteoporosis induced by glucocorticoids excess in comparison to post menopausal osteoporosis thanks to pQCT analysis.


title: Role of Myostatin, Activin A and Follistatin Cachexia of ENT Cancers

acronym: MYOCACH

summary: The main objective of our study was to determine the modifications of blood myostatin and activin A concentrations associated with head and neck cancers. Secondary objectives consisted in studying their influence on the occurrence of cachexia, bringing the proof of a tumoral secretion of these factors, and then determining the effect of tumor removal.


title: Treatment of Multiple Gingival Recession Defects Using a Xenogenic Acellular Dermal Matrix Compared to Connective Tissue Graft: a Randomized Controlled Clinical Study

acronym: MUCODERM

summary: Limitation of donor site and significant postoperative morbidity are often described in connective tissue graft harvesting. We want to show if mucoderm used in tunnel technique to recover miller class I and II recessions defects could be an alternative to connective tissue graft.

ReferenceType: derived

ReferenceCitation: Vincent-Bugnas S, Laurent J, Naman E, Charbit M, Borie G. Treatment of multiple gingival recessions with xenogeneic acellular dermal matrix compared to connective tissue graft: a randomized split-mouth clinical trial. J Periodontal Implant Sci. 2021 Apr;51(2):77-87. doi: 10.5051/jpis.2002400120.

name: Université Côte d'Azur, Département de Parodontologie, UFR Odontologie, Nice, France.

name: Centre Hospitalier Universitaire de Nice, Pôle d'Odontologie, Nice, France.

name: Université Côte d'Azur, Laboratoire MICORALIS EA7534, Nice, France.

family: Vincent-Bugnas

full_name: Séverine Vincent-Bugnas

given: Séverine

family: Laurent

full_name: Jonathan Laurent

given: Jonathan

family: Naman

full_name: Eve Naman

given: Eve

family: Charbit

full_name: Mathieu Charbit

given: Mathieu

family: Borie

full_name: Gwenaël Borie

given: Gwenaël

journal_name: Journal of Periodontal & Implant Science

oa_host_type: repository

evidence: oa repository (via pmcid lookup)

host_type: repository

license_normalized: no license

repository_normalized: PubMed Central

version: publishedVersion

publisher: Korean Academy of Periodontology

publisher_dissemination: Korean Academy of Periodontology

publisher_group: Korean Academy of Periodontology

publisher_normalized: Korean Academy of Periodontology


title: Impact of Neuropsychological Alteration of Decision-making Abilities on the Functioning of Patients With Eating Disorders

summary: Eating disorders are multifactorial disorders currently conceptualized in a biopsychosocial model, but pathophysiology remains relatively unknown, and robust etiological models to guide treatment are therefore lacking. Different endophenotypes and neurocognitive vulnerability factors have been found in eating disorders including decision making abnormalities. The investigators hypothesize that decision making abnormalities are associated with a lower level of functioning and quality of life which could lead to social and interpersonal difficulties. The investigators also hypothesize that these anomalies are associated with a particular clinical profile (more restrictive profile, more hyperactivity, less insight on the disease and desire for care ...).


acronym: DTCHT

summary: The aim of the study is to describe CBF modifications during rewarming after targeted temperature management in cardiac arrest patients

lead_sponsor: University Hospital, Brest


title: Innovative Planning and Guidance System for Prostate Focal Brachytherapy

acronym: FOCUS

summary:
A key feature of low-dose brachytherapy is that irradiation affects only a local area around the inserted radiation sources. The exposure of healthy tissues around these sources is then reduced. However, the number of adverse events remains high (about 79% of patients with sexual problems and 30% of patients with urinary incontinence) and brachytherapy is no better than other treatment options for Preservation of the urethral apparatus (about 40% of patients).

The current technique for the implantation of radioactive sources, which has not been revised since the early 1980s, consists in imaging the prostate at the beginning of the intraoperative procedure with transrectal ultrasound in order to evaluate the size and shape of the prostate . This information is then used to identify the best distribution of the dose of radiation to be administered to each patient. This treatment planning step is based on a procedure where the operator manually places 50 to 100 grains of iodine in the prostate. These grains are inserted transperinally under transrectal 2D ultrasound control, using needles through a transperineal grid with several needle guides evenly spaced 5 mm apart. This is an arduous task because this manual grain placement procedure must take into account the dose to be administered to the prostate without exceeding the dose limit for the surrounding organs at risk (rectum, urethra). In addition, the overestimation of the dose formality called TG-43 and the inaccurate grain placement can contribute to the creation of cold spots where no dose is administered. It may be responsible for recurrences of prostate cancer after brachytherapy treatment. Although brachytherapy dosimetry has been extensively researched, the TG-43 dose formalism has been the benchmark for the last 20 years. Moreover, from an economic point of view, the high side-effects rates of the treatment of prostate cancer result in particularly expensive post-treatment costs. The search for improved solutions for the treatment of prostate cancer remains a major societal challenge.

In recent years, a very attractive therapeutic alternative between active surveillance and overall treatment is gaining popularity among experts: focal therapy.

It is a localized treatment, limited to cancerous areas, in order to preserve healthy functional tissues inside and outside the organ and thus the quality of life of the patient.

Focal therapy is also often the preferred solution for recovery therapy (second intervention).

Finally, focal therapy has great potential to reduce the cost and duration of the intervention, as well as the cost of follow-up.

In recent years, several energies have been proposed as being adapted to focal therapy, such as high intensity focal ultrasound, laser ablation and cryotherapy. Brachytherapy, which already gives above average results in the treatment of whole glands, has been identified as a very good candidate for this new therapeutic paradigm.

In brachytherapy, radioactive grains are implanted in the prostate using transperineal catheters. The rapid reduction of the dose according to the distance of the radioactive seeds gives the physician a great flexibility to control the radiation accurately. It allows intermediate approaches between global and focal treatments, providing great scalability, and it is a good candidate for recovery therapy.

Recent studies have shown that focal brachytherapy allows more than half of the needles and seeds to act more strongly on the target while irradiating Significantly less The urethra and rectum. Clinical studies on this subject are still limited and further research is needed to confirm the performance of this approach.


title: Development of MRI Protocols and Associated Explorations (EEG, NIRS) in Voluntary Patients

acronym: MAP-PV

summary: Studies that will be carried out on healthy volunteers will have as main objective the development and optimization of the parameters of sequences or the design of the paradigms of stimulation in order to optimize the quality and the relevance of the images realized taking in Taking account of anatomical, functional or metabolic parameters, or integrating new approaches resulting from technical evolutions

primary_purpose: Basic Science

lead_sponsor: University Hospital, Grenoble


title: Nasal Ventilation Versus Voluntary Hypoventilation in the Rehabilitation of Hyperventilation Syndrome: a Randomized, Controlled Trial

acronym: RehabSHV

summary: The main objective of this study is to measure the effect (at 3 months) of dyspnea control rehabilitation with nasal ventilation versus standard rehabilitation, in dyspneic patients with hyperventilation syndrome.


title: Influence of Surgeon-anesthesiologist Collaboration on Patient Outcomes After Pheochromocytoma Surgery

acronym: CCAP

summary: Collaboration between the surgeon and the anesthesiologist is key for delivering a safe pheochromocytoma surgery. This study aims to establish the collective performance of surgeon-anesthesiologist team by quantifying the relationship between their previous collaborations and patient complications.

location_facility: Pôle Information Médicale Evaluation Recherche des Hospices Civils de Lyon - Centre Hospitalier Lyon Sud


ReferenceCitation: Laterre PF, Sánchez-García M, van der Poll T, de la Rosa O, Cadogan KA, Lombardo E, François B. A phase Ib/IIa, randomised, double-blind, multicentre trial to assess the safety and efficacy of expanded Cx611 allogeneic adipose-derived stem cells (eASCs) for the treatment of patients with community-acquired bacterial pneumonia admitted to the intensive care unit. BMC Pulm Med. 2020 Nov 25;20(1):309. doi: 10.1186/s12890-020-01324-2.

family: Laterre

full_name: Pierre-François Laterre

given: Pierre-François

family: Sánchez-García

full_name: Miguel Sánchez-García

given: Miguel

family: van der Poll

full_name: Tom van der Poll

given: Tom

family: de la Rosa

full_name: Olga de la Rosa

given: Olga

family: Cadogan

full_name: Kathy-Ann Cadogan

given: Kathy-Ann

family: Lombardo

full_name: Eleuterio Lombardo

given: Eleuterio

family: François

full_name: Bruno François

given: Bruno

currency_apc_doaj: GBP

journal_name: BMC Pulmonary Medicine

oa_colors: green gold

oa_host_type: publisher;repository

evidence: oa journal (via doaj)

host_type: publisher

license: cc-by

license_normalized: cc-by

publisher: Springer Science and Business Media LLC

publisher_dissemination: Springer-Nature

publisher_group: Springer-Nature

publisher_normalized: Springer

status: Active, not recruiting

ipd_sharing_description: Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement..

lead_sponsor: Tigenix S.A.U.

acronym: SEPCELL

location_facility: Centre Hospitalier Departemental les Ouidairies

ipd_sharing: Yes

title: A Phase Ib/IIa, Randomised, Double Blind, Parallel Group, Placebo Controlled, Multicentre Study to Assess the Safety and Efficacy of Expanded Cx611 Allogeneic Adipose-derived Stem Cells (eASCs) for the Intravenous Treatment of Adult Patients With Severe Community-acquired Bacterial Pneumonia and Admitted to the Intensive Care Unit

summary:
The purpose of this randomised, multicentre, double-blind, placebo-controlled, phase Ib/IIa study is to assess the safety, tolerability and efficacy of eASCs (Cx611) administered intravenously as adjunctive therapy, therefore in addition to standard of care (SoC) therapy, to patients with severe community-acquired bacterial pneumonia (sCABP).

The completion of this study will contribute to the basic knowledge on stem cells and their mode-of-action, and has a large translational character, i.e. to document the safety and explore the efficacy of Cx611 in patients with sCABP.

lead_sponsor_type: industriel


title: Comparison of Two Initial Evaluation Scales of the Severity of Brain Injury Adults

acronym: CASSANDRA

summary:
Prospective cohort study. Any patient with potential cerebral injured (medical or traumatic) will be included in the study, regardless of its severity, history, the presence of anticoagulant or antiagrégant.

The collection should be done as soon as possible, in the reception of vital emergencies or in the urgencies. The collection consists of the realization of a Glasgow score and a scale of Kremlin-Bicêtre for all patients by completing a standardized collection sheet. The collection of GCS and Kremlin-Bicêtre must be did at the same time. The collection sheet is filled by medical personnel trained.

The future of the patient is informed at 6 months using the Glasgow Outcome Scale- Extended, which will be made during a following consultation or by phone. Additional data will be collected on the folder (ventilation time, days of hospitalization, mortality).

lead_sponsor: Poitiers University Hospital


title: Clinical Evaluation of the Performance of a Difluoroethane-based Cyto-selective Cryotherapy to Treat Dark Spots on the Hand in 30 Volunteers.

acronym: CBT

summary: This study evaluates the performance of "CRYOBEAUTY MAINS", a Cyto-selective Cryotherapy based on Difluoroethane as a treatment of Solar Lentigines in 30 volunteers. Only one application of "CRYOBEAUTY MAINS" in one hand (right or left hand according to the randomization code).

lead_sponsor: Cryobeauty


title: Peripheral Ischemia Evolution Assessed by Ultra-wide Field Angiography in Patients With Diabetic Macular Edema

summary: Patients with diabetic macular edema treated with aflibercept injections for visual impairment will be observed in standard care during 12 months. They will undergo visual assessments by Ultrawide Field angiography at baseline and at 12 months

lead_sponsor: Association Pour La Recherche En Vision Du Service D'Ophtalmologie De L'Hôpital


title: Evaluation of the Prevalence of Functional Digestive Disorders During Primary Sjögren Gougerot Syndrome

acronym: GASTRO-SGS

summary: the investigators propose to carry out a prospective study consisting of a systematic research of digestive symptoms in patients with SGSp with the validated Global symptom score (GSS) questionnaire, which allowed to grades severity of 10 digestive symptoms (absent, mild, moderate, or severe), asthenia and fever.

ReferenceCitation: Parreau S, Jacques J, Dumonteil S, Palat S, Geyl S, Gondran G, Bezanahary H, Liozon E, Azaïs J, Colombie S, Jauberteau MO, Loustaud-Ratti V, Ly KH, Fauchais AL. Abdominal symptoms during Sjogren's syndrome: a pilot study. Adv Rheumatol. 2021 Jan 19;61(1):5. doi: 10.1186/s42358-021-00164-w.

apc_source: doaj

family: Parreau

full_name: Simon Parreau

given: Simon

family: Jacques

full_name: Jérémie Jacques

given: Jérémie

family: Dumonteil

full_name: Stéphanie Dumonteil

given: Stéphanie

family: Palat

full_name: Sylvain. Palat

given: Sylvain.

family: Geyl

full_name: Sophie Geyl

given: Sophie

family: Gondran

full_name: Guillaume Gondran

given: Guillaume

family: Bezanahary

full_name: Holy Bezanahary

given: Holy

family: Liozon

full_name: Eric Liozon

given: Eric

family: Azaïs

full_name: Julie Azaïs

given: Julie

family: Colombie

full_name: Stéphanie Colombie

family: Jauberteau

full_name: Marie-Odile Jauberteau

given: Marie-Odile

family: Loustaud-Ratti

full_name: Véronique Loustaud-Ratti

given: Véronique

family: Ly

full_name: Kim-Heang Ly

given: Kim-Heang

family: Fauchais

full_name: Anne-Laure Fauchais

given: Anne-Laure

currency_apc_doaj: EUR

journal_name: Advances in Rheumatology

oa_host_type: publisher

title: Abdominal symptoms during Sjogren’s syndrome: a pilot study

lead_sponsor: University Hospital, Limoges


title: Alternative Splicing and Leukemia Initiating Cells

acronym: ASLIC

summary:
Aberrant RNA splicing and mutations in spliceosome complex in acute myeloid leukaemia (AML) are frequent. It have been shown that some splicing variants had a prognostic value in AML.

AML are characterized by their propensity to relapse because of the persistence of leukaemia initiating cells (LICs).

The aim of this study is to determine the splice variants on AML initiator cells and define a splicing pattern.

location_facility: Service d'hématologie du Centre Hospitalier Lyon Sud


title: High Dosage Buprenorphine as a Drug Strategy Withdrawal Assistance of Analgesics Opioid After Failure of an Opioid Tapering-off Strategy.

acronym: SEVROP

summary:
The prevalence of analgesics opioids addiction in chronic pain patient is very difficult to know. Many studies indicated that the prevalence of addiction varied from 0% up to 50% in chronic non cancer pain patients, and from 0% up to 7.7% in cancer pain patients. Analgesics opioids use have increasingly been increased in chronic pain for 20 years. However, a long use, at least 3 months in this type of pain has not proved a large efficiency and we have noticed a habituation, tolerance and withdrawal when treatment was decreased or stopped. In current practice, patients with chronic pain, often keep their analgesics opioids despite the absence of pain relief and benefits in quality of life.

Nowadays, no withdrawal strategy is the reference in chronic non-cancer pain patients with physical opioid dependence. The most common clinical strategy is progressive decrease of analgesic opioid. But this strategy is often a failure in these patients (no data are available in literature).

It's necessary to make a prospective pilot study to assess benefits from this practice.

The primary objective of this study is to assess a new ambulatory withdrawal strategy, consisting of a temporary opioid rotation with buprenorphine in CNCP patients suffering from physical withdrawal symptoms and who have failed a conventional strategy of progressive withdrawal from their opioid analgesic treatment.


title: Impacts of the α-fetoprotein (AFP) Score in Real Life for Patient Selection for Liver Transplantation (LT) for Hepatocellular Carcinoma (HCC)

acronym: Impact AFP

summary: This is a French multicentric retrospective study on intention-to-treat comparing results of LT for HCC before and after the use of the AFP score. The investigators hypothesis is a better respect of the Biomedicine Agency (the French national transplantation agency) criteria since the general application of this score in March 2013. The aim of this study is to determine if the tumoral characteristics at the time of LT are improved and if it modified the patients'outcome.

ReferenceCitation: Decaens T, Roudot-Thoraval F, Bresson-Hadni S, Meyer C, Gugenheim J, Durand F, Bernard PH, Boillot O, Boudjema K, Calmus Y, Hardwigsen J, Ducerf C, Pageaux GP, Dharancy S, Chazouilleres O, Dhumeaux D, Cherqui D, Duvoux C. Impact of pretransplantation transarterial chemoembolization on survival and recurrence after liver transplantation for hepatocellular carcinoma. Liver Transpl. 2005 Jul;11(7):767-775. doi: 10.1002/lt.20418.

ReferenceCitation: Decaens T, Roudot-Thoraval F, Hadni-Bresson S, Meyer C, Gugenheim J, Durand F, Bernard PH, Boillot O, Sulpice L, Calmus Y, Hardwigsen J, Ducerf C, Pageaux GP, Dharancy S, Chazouilleres O, Cherqui D, Duvoux C. Impact of UCSF criteria according to pre- and post-OLT tumor features: analysis of 479 patients listed for HCC with a short waiting time. Liver Transpl. 2006 Dec;12(12):1761-9.

ReferenceCitation: Decaens T, Roudot-Thoraval F, Bresson-Hadni S, Meyer C, Gugenheim J, Durand F, Bernard PH, Boillot O, Compagnon P, Calmus Y, Hardwigsen J, Ducerf C, Pageaux GP, Dharancy S, Chazouillères O, Cherqui D, Duvoux C. Role of immunosuppression and tumor differentiation in predicting recurrence after liver transplantation for hepatocellular carcinoma: a multicenter study of 412 patients. World J Gastroenterol. 2006 Dec 7;12(45):7319-25.

ReferenceCitation: Decaens T, Roudot-Thoraval F, Badran H, Wolf P, Durand F, Adam R, Boillot O, Vanlemmens C, Gugenheim J, Dharancy S, Bernard PH, Boudjema K, Calmus Y, Hardwigsen J, Ducerf C, Pageaux GP, Hilleret MN, Chazouillères O, Cherqui D, Mallat A, Duvoux C. Impact of tumour differentiation to select patients before liver transplantation for hepatocellular carcinoma. Liver Int. 2011 Jul;31(6):792-801. doi: 10.1111/j.1478-3231.2010.02425.x. Epub 2011 Mar 31.

ReferenceCitation: Duvoux C, Roudot-Thoraval F, Decaens T, Pessione F, Badran H, Piardi T, Francoz C, Compagnon P, Vanlemmens C, Dumortier J, Dharancy S, Gugenheim J, Bernard PH, Adam R, Radenne S, Muscari F, Conti F, Hardwigsen J, Pageaux GP, Chazouillères O, Salame E, Hilleret MN, Lebray P, Abergel A, Debette-Gratien M, Kluger MD, Mallat A, Azoulay D, Cherqui D; Liver Transplantation French Study Group. Liver transplantation for hepatocellular carcinoma: a model including α-fetoprotein improves the performance of Milan criteria. Gastroenterology. 2012 Oct;143(4):986-94.e3; quiz e14-5. doi: 10.1053/j.gastro.2012.05.052. Epub 2012 Jun 29.

ReferenceCitation: Brusset B, Dumortier J, Cherqui D, Pageaux GP, Boleslawski E, Chapron L, Quesada JL, Radenne S, Samuel D, Navarro F, Dharancy S, Decaens T. Liver Transplantation for Hepatocellular Carcinoma: A Real-Life Comparison of Milan Criteria and AFP Model. Cancers (Basel). 2021 May 19;13(10). pii: 2480. doi: 10.3390/cancers13102480.

family: Brusset

full_name: Bleuenn Brusset

given: Bleuenn

family: Dumortier

full_name: Jerome Dumortier

given: Jerome

family: Cherqui

full_name: Daniel Cherqui

given: Daniel

family: Pageaux

full_name: Georges-Philippe Pageaux

given: Georges-Philippe

family: Boleslawski

full_name: Emmanuel Boleslawski

given: Emmanuel

family: Chapron

full_name: Ludivine Chapron

given: Ludivine

family: Quesada

full_name: Jean-Louis Quesada

given: Jean-Louis

family: Radenne

full_name: Sylvie Radenne

given: Sylvie

family: Samuel

full_name: Didier Samuel

given: Didier

family: Navarro

full_name: Francis Navarro

given: Francis

family: Dharancy

full_name: Sebastien Dharancy

given: Sebastien

family: Decaens

full_name: Thomas Decaens

given: Thomas

currency_apc_doaj: CHF

journal_name: Cancers

publisher: MDPI AG

publisher_dissemination: MDPI

publisher_group: MDPI

publisher_normalized: MDPI


title: Evaluation of the Clinical Performance of Optimized Angiomammography and Comparison With Standard Angiomammography

acronym: OPTIAM

summary:
This study will be proposed consecutively to any patient who angiomammography examination was requested by the clinician in charge of patient. A randomization will be performed between an angiomammography examination Standard (SenoBright®) and an optimized angiomammography examination.

A blinded central re-reading of the acquisition technique will be carried out by 3 radiologists (2 seniors and 1 junior) who will evaluate:

The intensity of lesion enhancement
The presence and type of artefacts on the recombined images.
The quality of low-energy images according to recognized criteria for mammography.

The gold standard will be histology (biopsies or surgery) or follow-up to 1 year for non-biopsied benign lesions

lead_sponsor: Gustave Roussy, Cancer Campus, Grand Paris


title: Early Detection and Paramedical Care of Sexual Difficulties in Nervous System Diseases: Example of Multiple Sclerosis and Brain Tumors

acronym: NEUROSEX

summary: This study aim to ensure that the implementation of a paramedical screening program and counseling in sexual health of patients with neurological pathologies (low-grade gliomas and Multiple Sclerosis) improves their sexual health.


title: RITUX-PLUS. A Prospective Open Trial to Assess the Efficacy and Safety of a Treatment Combining Rituximab and Belimumab in Adults With Persistent Immune Thrombocytopenia.

acronym: RITUX PLUS

summary: Previous studies have shown that increase level of BAFF could promote the settlement of long-lived plasma cells in the spleen of ITP patients treated with anti-CD20. This single-center prospective pilot study, currently in phase IIa, will evaluate the efficacy of a rituximab and belimumab sequential combination treatment. Investigators plan to include 15 patients with persistent ITP over a 24-month inclusion period. Each patient will be followed for 1 year

ReferenceCitation: Mahévas M, Azzaoui I, Crickx E, Canoui-Poitrine F, Gobert D, Languille L, Limal N, Guillaud C, Croisille L, Jeljeli M, Batteux F, Baloul S, Fain O, Pirenne F, Weill JC, Reynaud CA, Godeau B, Michel M. Efficacy, safety and immunological profile of combining rituximab with belimumab for adults with persistent or chronic immune thrombocytopenia: results from a prospective phase 2b trial. Haematologica. 2021 Sep 1;106(9):2449-2457. doi: 10.3324/haematol.2020.259481.

family: Matthieu Mahévas

full_name: Matthieu Mahévas

family: Imane Azzaoui

full_name: Imane Azzaoui

family: Etienne Crickx

full_name: Etienne Crickx

family: Florence Canoui-Poitrine

full_name: Florence Canoui-Poitrine

family: Delphine Gobert

full_name: Delphine Gobert

family: Laetitia Languille

full_name: Laetitia Languille

family: Nicolas Limal

full_name: Nicolas Limal

family: Constance Guillaud

full_name: Constance Guillaud

family: Laure Croisille

full_name: Laure Croisille

family: Mohamed Jeljeli

full_name: Mohamed Jeljeli

family: Fréderic Batteux

full_name: Fréderic Batteux

family: Samia Baloul

full_name: Samia Baloul

family: Olivier Fain

full_name: Olivier Fain

family: France Pirenne

full_name: France Pirenne

family: Jean-Claude Weill

full_name: Jean-Claude Weill

family: Claude-Agnès Reynaud

full_name: Claude-Agnès Reynaud

family: Bertrand Godeau

full_name: Bertrand Godeau

family: Marc Michel

full_name: Marc Michel

journal_name: Haematologica

license: publisher-specific license

license_normalized: publisher-specific

publisher: Ferrata Storti Foundation (Haematologica)


title: Wake-sleep Cycle and Melatonin Secretion Dynamics Associated With 12 Hours Shift Work in French Nurses

summary: Nonstandard time-schedules work are widespread in the world of work. Shift and night work have been shown to be responsible for a desynchronization of biological rhythms, associated with melatonin secretion impairment and sleep disturbances. However, while health consequences of night and shift work are widely recognized and represent a major public health concern (High Authority of Health 2012 Recommendations and National Agency for Public Health Food, Environment and Work 2016 Report), the mechanisms by which the circadian system is affected by shift work remain poorly understood. Indeed most of the studies in the fields are cross-sectional, based on few blood or urinary samples in a single work position, in workers whose shift work patterns are often misidentified and heterogeneous. Moreover, few studies have assessed melatonin secretion alterations in relation to objective sleep measurement (actigraphy). The aim of this study is to assess the dynamics of melatonin secretion adaptation in 12-hour shift work and to correlate these data to sleep-wake cycle recording.

primary_purpose: Diagnostic


title: Efficacy And Safety Of High Concentration Capsaicin Patches In Knee Osteoarthritis In Obese Patients: A Randomized Prospective Double Blind Placebo Controlled Study

acronym: CHILI-OB

summary: To assess the efficacy and safety of high concentration capsaicin patches in pain due to osteoarthritis (OA) of the knee in patients with obesity

lead_sponsor: Nadine ATTAL

location_facility: Hospital Ambroise Paré, Nutrition Department


title: Assessments of Sarcopenia Prevalence in Chronic Heart Failure Patients and in Subjects Before Transcatheter Aortic Valve Implantation

acronym: PRESAR-HF

summary:
The main objective was to assess the prevalence of sarcopenia in chronic heart failure patients and in patients before the trans aortic valvular implantation.

The loss of muscle mass in chronic heart failure patients is a prognostic factor for sarcopenia. The purpose was to identify in these patients signs of sarcopenia for a better management.

ReferenceCitation: Eschalier R, Massoullié G, Boirie Y, Blanquet M, Mulliez A, Tartière PL, Anker S, D'Agrosa Boiteux MC, Richard R, Jean F, Combaret N, Souteyrand G, Riocreux C, Pereira B, Motreff P, Stolt P, Rossignol P, Clerfond G. Sarcopenia in patients after an episode of acute decompensated heart failure: An underdiagnosed problem with serious impact. Clin Nutr. 2021 Jun;40(6):4490-4499. doi: 10.1016/j.clnu.2020.12.033. Epub 2021 Jan 9.

family: Eschalier

full_name: Romain Eschalier

given: Romain

family: Massoullié

full_name: Grégoire Massoullié

given: Grégoire

family: Boirie

full_name: Yves Boirie

given: Yves

family: Blanquet

full_name: Marie Blanquet

given: Marie

family: Mulliez

full_name: Aurélien Mulliez

given: Aurélien

family: Tartière

full_name: Pierre-Louis Tartière

given: Pierre-Louis

family: Anker

full_name: Stefan Anker

given: Stefan

family: D'Agrosa Boiteux

full_name: Marie-Claire D'Agrosa Boiteux

given: Marie-Claire

family: Richard

full_name: Ruddy Richard

given: Ruddy

family: Jean

full_name: Frédéric Jean

given: Frédéric

family: Combaret

full_name: Nicolas Combaret

given: Nicolas

family: Souteyrand

full_name: Géraud Souteyrand

given: Géraud

family: Riocreux

full_name: Clément Riocreux

given: Clément

family: Pereira

full_name: Bruno Pereira

given: Bruno

family: Motreff

full_name: Pascal Motreff

given: Pascal

family: Stolt

full_name: Pelle Stolt

given: Pelle

family: Rossignol

full_name: Patrick Rossignol

given: Patrick

family: Clerfond

full_name: Guillaume Clerfond

given: Guillaume

journal_name: Clinical Nutrition

lead_sponsor: University Hospital, Clermont-Ferrand


title: Evaluation of the Pharmacokinetic Profile, Pharmacodynamic Effects, Acceptability and Tolerability of an Oral Amiodarone Solution of 15 mg / mL in Children With Supra Ventricular Tachycardia

acronym: Enteramio

summary:
The supra ventricular tachycardia is the most common symptomatic arrhythmia in pediatrics. Amiodarone is an antiarrhythmic drug used in this indication. Pharmacokinetic, efficacy and safety data are not known in the pediatric population due to the lack of a suitable specialty available on the market.

The development of an amiodarone oral solution formulation adapted to this age group should provide a therapeutic alternative and collect data on the pharmacokinetics, efficacy, acceptability and tolerability of the drug.

status: Withdrawn

lead_sponsor: Centre Hospitalier Universitaire, Amiens

intervention_type: Biological


title: Determinants of Adherence to Post-stroke/Transient Ischemic Attack Secondary Prevention Treatment: Cohort Study in the Rhône

acronym: OBSTACLE

summary:
The effectiveness of emergency management of acute ischemic stroke has improved considerably in recent years with thrombolysis and more recently thrombectomy. This improvement is accompanied by an increase in the number of stroke survivors. One of the major issues for these ever-increasing survivors is the prevention of recurrence. According to data from the 3 French registries, more than 20% of patients have at least one recurrence. Secondary prevention treatment has demonstrated his efficacy to prevent stroke recurrence.

This evolution justifies identifying factors associated with adherence to secondary prevention treatment, measured at 1 year post-stroke / transient ischemic attack (TIA), in patients included in the STROKE 69 cohort.

location_facility: Hospices Civils de Lyon, Pôle Information Médicale Evaluation Recherche


title: Development of MRI Protocols and Associated Explorations (EEG, NIRS) in Healthy Volunteers

acronym: MAP-VS

summary: The main objective of the studies that will be carried out on volunteer patients who have given their consent will be the development and optimization of the sequence parameters or the design of the stimulation paradigms in order to optimize the quality and Relevance of the images realized taking into account anatomical, functional or metabolic parameters. These adjustments will be carried out without interfering with the management of voluntary patients


title: Evaluation of a Simple Clinical Test to Detect the Risk of Falling in Patients With Chronic Obstructive Pulmonary Disease and Research for Predictive Factors of Fall Risk.

acronym: Equil-BPCO

summary:
The risk of falling in increased in patients with Chronic Obstructive Pulmonary Disease. To date, a screening test (the Berg Balance scale, BBS) is used to evaluate this risk but it spends 20 to 30 minutes to complete.

The aim of our study is to evaluate the sensitivity of a more straightforward test (Timed Up and Go, TUG)) to assess the fall risk. The TUG is routinely used in elderly to screen for frailty.


title: Measure of Intracranial Pressure Variations During Migraine Attacks

acronym: MigICP

summary: An increase in intracranial pressure (ICP) during migraine attacks is possible and could contribute to pain initiation and maintenance. From now on, it was not possible to measure ICP in a non-invasive way. The development of a new tool allows non-invasive self-measures of ICP variations. Thus, it is possible for the first time to look for such ICP variations during migraine attacks and to conclude if this mechanism is implied in the pathophysiology of migraine.


title: Effects of a Therapeutic Education Program on Treatment Adherence Among Patients Prescribed At-home Continuous Positive Airway Pressure or At-home Non-invasive Ventilation

acronym: APARDetp

summary: The primary objective of this study is to study the effect of therapeutic education on patient adherence for at-home continuous positive airway pressure (CPAP) or at-home non-invasive ventilation. This first study will use data already present in the Association for Home Assistance and Rehabilitation (APARD) database to compare patients who received therapeutic education with a control group who did not.


title: Survey About Oral Anticoagulant Peri-procedural Management in Patients Undergoing an Oral Surgery, Implantology or Periodontology

acronym: PRADICO

summary:
Patients receiving long-term oral anticoagulant (defined as duration of treatment of at least 1 month of Direct Oral Anticoagulant (DAOC) or Vitamin K Antagonist (VKA)) and referred for an invasive procedure (oral surgery, implantology or periodontology) to an oral surgeon taking part to the study will be included in this prospective observational study.

The main composite outcome is the occurrence rate of hemorrhagic and/or thromboembolic events during the peri-procedural period (between 5 days before surgery plus 30 days after the invasive procedure).

0. The secondary end-points will consist of identifying risk factors for bleeding during the peri-procedural period, risk factors for thromboembolic events during the peri-procedural period, the peri-procedural management of each treatment (VKA or DOAC), the prescribers involved in the possible change of anticoagulant prescription prior the oral surgery All outcome events will be blindly adjudicated by a central independent adjudication committee.

ReferenceCitation: Radoï L, Hajage D, Giboin C, Maman L, Monnet-Corti V, Descroix V, Mahé I. Perioperative management of oral anticoagulated patients undergoing an oral, implant, or periodontal procedure: a survey of practices of members of two dental scientific societies, the PRADICO study. Clin Oral Investig. 2019 Dec;23(12):4311-4323. doi: 10.1007/s00784-019-02877-1. Epub 2019 Mar 19.

family: Radoï

full_name: Loredana Radoï

given: Loredana

family: Hajage

full_name: David Hajage

given: David

family: Giboin

full_name: Caroline Giboin

given: Caroline

family: Maman

full_name: Louis Maman

given: Louis

family: Monnet-Corti

full_name: Virginie Monnet-Corti

given: Virginie

family: Descroix

full_name: Vianney Descroix

given: Vianney

family: Mahé

full_name: Isabelle Mahé

given: Isabelle

journal_name: Clinical Oral Investigations

lead_sponsor: Assistance Publique - Hôpitaux de Paris


title: CoHort of Patients to Identify Biological and Imaging markerS of CardiovascUlar Outcomes in Stroke.

acronym: HIBISCUSSTROKE

summary:
Ischemic stroke is the first cause of acquired disability of the adult, the second cause of dementia and the third cause of death in the industrialized countries, what constitutes à major public health issue. Stroke is characterized by a cerebral parenchymal lesion due to an ischemic mechanism (85% of the cases) or hemorrhagic mechanism (15%). For a long time, the only approved treatment was the intravenous thrombolysis (rt-PA). Recently, thrombectomy has proven its superiority in this pathology.

Cohorts of patients with stroke are rare but can be very valuable by their clinical, laboratory and imaging well documented. They are the source of new hypotheses for research or interventions as well as the quality of care assessment tool.

The main objective of this project is to identify new markers: biological and imaging, treatment response and prognosis after ischemic stroke.

Secondary objectives of the HIBISCUS-STROKE cohort are to establish a clinical database, completed by biological samples and by imaging data that can be used in the following areas:

Descriptive epidemiology of ischemic stroke and cerebral reperfusion,
Pharmacoepidemiology and treatments observatory: safety, efficacy, indication of treatment in real life, costs
Assessment of the long-term effect of the treatment on the occurrence of disability, stroke recurrence and death,
Quality of life and personal, familial, professional and social consequences of stroke,
Research of new diagnostic and prognostic biomarkers,
Research projects.

location_facility: Hôpital neurologique Pierre Wertheimer (Lyon)


title: Effects of a Dance Workshop on the Balance Abilities of Hemiparetic Patients

acronym: DanceStudio

summary: The majority of hemiparetic patients have balance disorders, which impact independence in daily living activities and walking. Conventional techniques used in rehabilitation improve balance but have shown no effects on dynamic balance required during walking. Recently dance is proposed to improve dynamic balance in older people and people with Parkinson's disease. Although many studies showed that dance is an effective activity to improve balance in these people, it has never been assessed in hemiparetic patients (except a case report). The aim of this study is to show that a dance program improves the balance of hemiparetic patients, compared to a control group. This randomized controlled study aims to include 40 hemiparetic patients who will perform a dance program (experimental group) or a upper-limb rehabilitation program (control group) for 8 one-hour sessions.

lead_sponsor: Centre d'Investigation Clinique et Technologique 805

location_facility: Raymond Poincaré Hospital- PMR Unit - Netter


title: Effectiveness of Mirror Therapy in Patients With Amputations of Lower Limbs of Vascular Origin

acronym: MIR-PHAN

summary: The aim of this study is to assess the efficacy of the mirror therapy on phantom pain for patients with amputation after vascular etiology. the secondary aim are to measure the impact of the mirror therapy on quality of life, sleep disorders, and predictive factors for effectiveness. the design is a prospective study, randomised, blindly evaluated, monocentric. There will be 2 groups: 1) rehabilitation and gabapentine; 2) rehabilitation and gabapentine + mirror therapy during the first 4 weeks. The assessment are going to be preformed at the inclusion day and then every 2 weeks during 8 weeks. the primary evaluation criterion will be the phantom pain measured on a VAS. the delay for inclusion is 18 months in order ton include 40 patients. The length of the study is 20 months.


title: Study of microRNAs in the Evolution of Carotid Plaque. Physiopathological and Therapeutic Interest

summary: Carotid stenosis of atherosclerotic origin may be responsible for stroke, which is one of the most important causes of morbidity and mortality in the Western world


title: Prevalence of Thyroid Function Abnormalities in HIV-infected Patients: State of Play in 2012

acronym: THYVI

summary: Review the evolution of thyroid function in HIV-infected patients, with sufficient follow-up.


title: Multicentric Cohort of HIV-1 (Human Immunodeficiency Virus 1) Primary Infection Cohort ANRS CO6 PRIMO

acronym: PRIMO

summary: Open, prospective, multicenter French cohort study enrolling subjects aged of 15 years or more, during or immediately after HIV-1 primary infection. This cohort was organized from the outset to be highly multidisciplinary, bringing together immunologists, virologists, clinicians and epidemiologists.

lead_sponsor: ANRS, Emerging Infectious Diseases


title: Advanced Breast Cancer and Lifestyle Exercise Study

acronym: ABLE

summary: About 5% of breast cancers are metastatic at diagnosis and 20-30% of localized breast cancer become secondarily metastatic.Thanks to recent therapeutic advances, the median survival ranges between 12 months in 1970 and 18 to 24 months in 2000. However, patients suffer from many detrimental symptoms such as fatigue, pain related to treatment and metastasis. The physical, biological, psychological and clinical benefits of physical activity (PA) during treatment in patients with localized breast cancer have been widely demonstrated. Numerous studies investigated the effect of PA in non-metastatic breast cancer, but to our knowledge, only four interventional studies worldwide focused on the implementation of PA in patients with metastatic breast cancer.It seems appropriate to investigate the feasibility of PA intervention with patients with metastatic breast cancer to see if the observed effects in localized breast cancer are confirmed in metastatic breast cancer population. The ABLE study is an interventional cohort designed to assess the feasibility of a 6-month adapted physical activity intervention, performed under real life conditions in patients with metastatic breast cancer.

primary_purpose: Supportive Care

ReferenceCitation: Delrieu L, Touillaud M, Pérol O, Morelle M, Martin A, Friedenreich CM, Mury P, Dufresne A, Bachelot T, Heudel PE, Fervers B, Trédan O, Pialoux V. Impact of Physical Activity on Oxidative Stress Markers in Patients with Metastatic Breast Cancer. Oxid Med Cell Longev. 2021 Jul 16;2021:6694594. doi: 10.1155/2021/6694594. eCollection 2021.

name: Inter-University Laboratory of Human Movement Biology EA7424, University Claude Bernard Lyon 1, University of Lyon, Lyon, France

name: Department of Cancer and Environment, Léon Bérard Cancer Center, Lyon, France

family: Delrieu

full_name: Lidia Delrieu

given: Lidia

name: Unité INSERM UA8, Centre Léon Bérard, Ministère des Armées, "Radiations: Défense, Santé et Environnement", Lyon, France

family: Touillaud

full_name: Marina Touillaud

given: Marina

family: Pérol

full_name: Olivia Pérol

given: Olivia

name: Department of Clinical Research and Innovation, Léon Bérard Cancer Center, Lyon, France

family: Morelle

full_name: Magali Morelle

given: Magali

family: Martin

full_name: Agnès Martin

given: Agnès

name: Department of Cancer Epidemiology and Prevention Research, Cancer Care Alberta, Alberta Health Services, Calgary, Alberta, Canada

name: Departments of Oncology and Community Health Sciences, Cumming School of Medicine, University of Calgary, Calgary, Alberta, Canada

family: Friedenreich

full_name: Christine M. Friedenreich

given: Christine M.

family: Mury

full_name: Pauline Mury

given: Pauline

name: Department of Medical Oncology, Léon Bérard Cancer Center, Lyon, France

family: Dufresne

full_name: Armelle Dufresne

given: Armelle

family: Bachelot

full_name: Thomas Bachelot

given: Thomas

family: Heudel

full_name: Pierre-Etienne Heudel

given: Pierre-Etienne

family: Fervers

full_name: Béatrice Fervers

given: Béatrice

family: Trédan

full_name: Olivier Trédan

given: Olivier

name: Institut Universitaire de France (IUF), Paris, France

family: Pialoux

full_name: Vincent Pialoux

given: Vincent

currency_apc_doaj: USD

journal_name: Oxidative Medicine and Cellular Longevity

evidence: oa repository (via OAI-PMH doi match)

repository_institution: University of Calgary - PRISM

publisher: Hindawi Limited

publisher_dissemination: Wiley

publisher_group: Wiley

publisher_normalized: Hindawi

ReferenceCitation: Delrieu L, Pialoux V, Pérol O, Morelle M, Martin A, Friedenreich C, Febvey-Combes O, Pérol D, Belladame E, Clémençon M, Roitmann E, Dufresne A, Bachelot T, Heudel PE, Touillaud M, Trédan O, Fervers B. Feasibility and Health Benefits of an Individualized Physical Activity Intervention in Women With Metastatic Breast Cancer: Intervention Study. JMIR Mhealth Uhealth. 2020 Jan 28;8(1):e12306. doi: 10.2196/12306.

ReferenceCitation: Delrieu L, Vallance JK, Morelle M, Fervers B, Pialoux V, Friedenreich C, Dufresne A, Bachelot T, Heudel PE, Trédan O, Pérol O, Touillaud M. Physical activity preferences before and after participation in a 6-month physical activity intervention among women with metastatic breast cancer. Eur J Cancer Care (Engl). 2020 Jan;29(1):e13169. doi: 10.1111/ecc.13169. Epub 2019 Sep 30.

name: Inter‐University Laboratory of Human Movement Biology EA7424 University of Lyon Villeurbanne France

name: Department of Cancer and Environment Leon Berard Cancer Center Lyon France

name: Faculty of Health Disciplines Athabasca University Athabasca Alberta Canada

name: Department of Clinical Research and Innovation Leon Berard Cancer CenterLyon France

name: Cancer Research Center of Lyon Leon Berard Cancer Center INSERM UA8 Lyon France

name: Institut Universitaire de France (IUF) Paris France

name: Department of Cancer Epidemiology and Prevention Research Cancer Control Alberta Alberta Health Services Calgary Alberta Canada

name: Departments of Oncology and Community Health Sciences Cumming School of Medicine University of Calgary Calgary Alberta Canada

name: Department of Medical Oncology Leon Berard Cancer Center Lyon France

title: Physical activity preferences before and after participation in a 6‐month physical activity intervention among women with metastatic breast cancer

ReferenceCitation: Delrieu L, Pérol O, Fervers B, Friedenreich C, Vallance J, Febvey-Combes O, Pérol D, Canada B, Roitmann E, Dufresne A, Bachelot T, Heudel PE, Trédan O, Touillaud M, Pialoux V. A Personalized Physical Activity Program With Activity Trackers and a Mobile Phone App for Patients With Metastatic Breast Cancer: Protocol for a Single-Arm Feasibility Trial. JMIR Res Protoc. 2018 Aug 30;7(8):e10487. doi: 10.2196/10487.


title: BetaLACTA® Test-guided Early De-escalation of Empirical Carbapenems in Pulmonary, Urinary and Bloodstream Infections Diagnosed in Intensive Care Unit - BLUE¬-CarbA Study

acronym: BLUE-CarbA

summary:
The emergence and rapid worldwide spread of Extended- Spectrum Beta-Lactamase-producing enterobacteriaceae (ESBLE) both in hospital and community, led physicians, and notably intensivists, to prescribe more carbapenems, particularly in the most fragile patients such as ICU patients. Unfortunately, the increased carbapenem consumption favored the emergence of carbapenem resistance mechanisms. Moreover, several preliminary results suggest that carbapenem could markedly impact the human intestinal microbiota, Thus, reduction of carbapenem exposure is widely desired both by national and international antibiotic plans. Therefore, the use of rapid diagnostic tests evaluating bacterial resistance to reduce inappropriate exposure to carbapenems could be a relevant solution. Due to its good diagnostic performance, the betaLACTA® test could meet these objectives.

Experimental plan :

Randomized, open-labeled non-inferiority clinical trial involving an in vitro diagnostic medical device (close to a phase III study), comparing two parallel groups:

Experimental group: early carbapenems de-escalation since the second dose, guided by results of the betaLACTA® test performed directly on the bacterial pellet from the microbiological sample positive on direct examination.
Control group: carbapenems de-escalation guided by definitive results of the antibiotic susceptibility test obtained 48 to 72h after microbiological sampling (reference strategy).

ReferenceCitation: Garnier M, Gallah S, Vimont S, Benzerara Y, Labbe V, Constant AL, Siami S, Guerot E, Compain F, Mainardi JL, Montil M, Quesnel C; BLUE-CarbA study group. Multicentre randomised controlled trial to investigate usefulness of the rapid diagnostic βLACTA test performed directly on bacterial cell pellets from respiratory, urinary or blood samples for the early de-escalation of carbapenems in septic intensive care unit patients: the BLUE-CarbA protocol. BMJ Open. 2019 Feb 19;9(2):e024561. doi: 10.1136/bmjopen-2018-024561.

family: Garnier

full_name: Marc Garnier

given: Marc

family: Gallah

full_name: Salah Gallah

given: Salah

family: Vimont

full_name: Sophie Vimont

given: Sophie

family: Benzerara

full_name: Yahia Benzerara

given: Yahia

family: Labbe

full_name: Vincent Labbe

family: Constant

full_name: Anne-Laure Constant

given: Anne-Laure

family: Siami

full_name: Shidasp Siami

given: Shidasp

family: Guerot

full_name: Emmanuel Guerot

given: Emmanuel

family: Compain

full_name: Fabrice Compain

given: Fabrice

family: Mainardi

full_name: Jean-Luc Mainardi

given: Jean-Luc

family: Montil

full_name: Mélissa Montil

given: Mélissa

family: Quesnel

full_name: Christophe Quesnel

given: Christophe

journal_name: BMJ Open

license: cc-by-nc

license_normalized: cc-by-nc

repository_institution: PubMed Central - Europe PMC

publisher: BMJ

publisher_dissemination: British Medical Journal

publisher_group: British Medical Journal

publisher_normalized: British Medical Journal

location_facility: Anesthesiology and Critical Care Medicine Department


title: Search for Restenosis Markers in Lower Limb Arteritis

acronym: FEMIA

summary:
The initial hypothesis of this work is that the genesis and the evolution of the atheromatous plaque are partly controlled at the molecular level and in particular by the microRNAs through their role as regulator of the genes.

The study of the tissue and serum profile over time of specific microRNAs involved in the regulation of atheromatous plaque correlated with clinical data and restenosis imaging will allow to define biological markers of restenosis in the patient with an arteritis of the lower limbs .

This study is a pioneer in the field and it would be imprudent to conclude that a biomarker would be used clinically at the end of this work alone. Nevertheless this study will make a major advance in this topic, in vivo intervention studies with inhibition or over-expression of microRNA will obviously be necessary to confirm the use of these as biomarkers of arteritis of the lower limbs.

Regular assay of reliable biomarkers in arterial patients will ultimately suggest early management to best adapt surgical and medical treatment.


title: Study of the Efficacy of N-acetylcysteine (NAC) on Impulse Control Disorders (TCI) Induced by Dopaminergic Treatments in Parkinson's Disease

acronym: NoISE-PD

summary: Impulse control disorders encountered in Parkinson's disease (PD) are induced by dopaminergic medications and their frequency is estimated to be nearly 20%, mainly under dopaminergic agonists (AD).


title: Diagnosis Accuracy of Abdominal Compression and Hemoconcentration to Detect Diuretic Induced Fluid Removal Intolerance.

summary: Fluid overload increases morbidity and mortality of pediatrics patients in intensive care unit (ICU). It could be interesting to predict the decrease in stroke volume when diuretics are prescribed. Nevertheless, no test predict a decrease of stroke volume in a context of a diuretics induced depletion. Abdominal compression (AC) coupled with echocardiographic measurement of the stroke volume can predict fluid responsiveness and is a good tool to assess preload dependency. Another point is that during depletion refilling can occur. We aim to assess the diagnostic accuracy of abdominal compression to predict a decrease of the stroke volume of 15 % during diuretic-induced depletion of 10 ml/kg of diuresis. Secondary outcome will assess the hemoconcentration during depletion to diagnose a decrease of stroke volume during diuretic induced depletion

ReferenceCitation: Foland JA, Fortenberry JD, Warshaw BL, Pettignano R, Merritt RK, Heard ML, Rogers K, Reid C, Tanner AJ, Easley KA. Fluid overload before continuous hemofiltration and survival in critically ill children: a retrospective analysis. Crit Care Med. 2004 Aug;32(8):1771-6.

ReferenceCitation: Sinitsky L, Walls D, Nadel S, Inwald DP. Fluid overload at 48 hours is associated with respiratory morbidity but not mortality in a general PICU: retrospective cohort study. Pediatr Crit Care Med. 2015 Mar;16(3):205-9. doi: 10.1097/PCC.0000000000000318.

family: Sinitsky

full_name: Lynn Sinitsky

given: Lynn

family: Walls

full_name: David Walls

given: David

family: Nadel

full_name: Simon Nadel

given: Simon

family: Inwald

full_name: David P. Inwald

given: David P.

journal_name: Pediatric Critical Care Medicine

publisher: Ovid Technologies (Wolters Kluwer Health)

publisher_dissemination: Wolters Kluwer Health

publisher_group: Wolters Kluwer Health

publisher_normalized: Wolters Kluwer Health

title: Fluid Overload at 48 Hours Is Associated With Respiratory Morbidity but Not Mortality in a General PICU

ReferenceCitation: Li Y, Wang J, Bai Z, Chen J, Wang X, Pan J, Li X, Feng X. Early fluid overload is associated with acute kidney injury and PICU mortality in critically ill children. Eur J Pediatr. 2016 Jan;175(1):39-48. doi: 10.1007/s00431-015-2592-7. Epub 2015 Jul 24.

family: Li

full_name: Yanhong Li

given: Yanhong

family: Wang

full_name: Jian Wang

given: Jian

family: Bai

full_name: Zhenjiang Bai

given: Zhenjiang

family: Chen

full_name: Jiao Chen

given: Jiao

full_name: Xueqin Wang

given: Xueqin

family: Pan

full_name: Jian Pan

full_name: Xiaozhong Li

given: Xiaozhong

family: Feng

full_name: Xing Feng

given: Xing

journal_name: European Journal of Pediatrics

ReferenceCitation: Monnet X, Cipriani F, Camous L, Sentenac P, Dres M, Krastinova E, Anguel N, Richard C, Teboul JL. The passive leg raising test to guide fluid removal in critically ill patients. Ann Intensive Care. 2016 Dec;6(1):46. doi: 10.1186/s13613-016-0149-1. Epub 2016 May 20.

family: Monnet

full_name: Xavier Monnet

given: Xavier

family: Cipriani

full_name: Flora Cipriani

given: Flora

family: Camous

full_name: Laurent Camous

given: Laurent

family: Sentenac

full_name: Pierre Sentenac

given: Pierre

family: Dres

full_name: Martin Dres

given: Martin

family: Krastinova

full_name: Evguenia Krastinova

given: Evguenia

family: Anguel


title: Prevalence of Asymptomatic Thrombosis in Multiple Myeloma

summary:
Malignant hemopathies, such as solid cancers, increase the risk of venous and arterial thromboembolic events. The incidence of symptomatic venous thromboembolic events is particularly high in myeloma, linked to the usual risk factors for venous thromboembolic disease, biological risk factors specific to myeloma, and especially to its treatments.

The prevalence of asymptomatic venous thromboembolic events and arterial events are not known to date and remain important data for planning a possible randomized study to determine the most suitable thromboprophylaxis in these patients.


title: Objective Markers of Pain Perception in Pediatric Emergency

acronym: TAMALOU

summary: Pain is a major problem in the care of children in pediatric emergencies. Indeed, its relief rests on the oral communication of the young patient, who does not always able to it (difficult to verbalize, fear of the hospital, problem mental development ...). There is no way in which pain can be apprehended objectively, immediately and effectively. To advance our knowledge of this problem, several approaches have been studied as from functional magnetic resonance imaging (fMRI), electroencephalography (EEG), or from autonomic parameters. However, all these approaches have their limitations: although fMRI presents interesting performances, it allows only a retrospective analysis, and cannot adapt to the clinical context of the young patient for example. EEG-based approaches and autonomic parameters show interesting results but suffer from perfectible sensitivity to muscle activation for EEG whereas the vegetative parameters to stress. In this context, our working hypothesis considers that the search for markers of painful perception must be based on a neurophysiological approach, based on the combined analysis of the EEG and autonomic responses in real time. The aim of this work is to study (1) the cortical (EEG) and autonomic (cardiovascular, skin, pupillary) responses induced by sutures in children who can communicate their pain according to whether they cause pain or not.

lead_sponsor: Centre Hospitalier Universitaire de Saint Etienne


title: Prospective, Randomized, Cross-over, Multicenter, Trial Comparing the Efficacy and Tolerability of Nasal Irrigation With Respimer® Netiflow® Mineral Salts Solution Versus Saline Among Patients With Cystic Fibrosis and Suffering From Chronic Rhinosinusitis

acronym: Respire

summary: Prospective, randomized, cross-over, multicenter, trial comparing the efficacy and tolerability of nasal irrigation with Respimer® mineral salts solution versus saline solution both administered with Respimer® Netiflow® medical device among patients aged ≥ 11 years and older with cystic fibrosis and suffering from chronic rhinosinusitis.

lead_sponsor: Laboratoire de la Mer

location_facility: ORL et Chirurgie Cervico-faciale Centre Hospitalier Intercommunal (CHI) de Créteil


title: Arterial Catheterization by Ultrasound: Impact on Success Rates and Complications in Patients Hospitalized in Resuscitation

acronym: ACTIVE

summary: Monitoring of invasive blood pressure and / or cardiac output of resuscitation patients is required and recommended

ReferenceCitation: Flumignan RL, Trevisani VF, Lopes RD, Baptista-Silva JC, Flumignan CD, Nakano LC. Ultrasound guidance for arterial (other than femoral) catheterisation in adults. Cochrane Database Syst Rev. 2021 Oct 12;10:CD013585. doi: 10.1002/14651858.CD013585.pub2. Review.

name: Department of Surgery, Division of Vascular and Endovascular Surgery; Universidade Federal de São Paulo; São Paulo Brazil

family: Flumignan

full_name: Ronald LG Flumignan

given: Ronald LG

name: Emergency Medicine; Universidade Federal de São Paulo; São Paulo Brazil

name: Rheumatology; Universidade de Santo Amaro; São Paulo Brazil

family: Trevisani

full_name: Virginia FM Trevisani

given: Virginia FM

name: Division of Cardiology; Duke University Medical Center; Durham USA

family: Lopes

full_name: Renato D Lopes

given: Renato D

name: Evidence-based Medicine; Cochrane Brazil; São Paulo Brazil

family: Baptista-Silva

full_name: Jose CC Baptista-Silva

given: Jose CC

full_name: Carolina DQ Flumignan

given: Carolina DQ

family: Nakano

full_name: Luis CU Nakano

given: Luis CU

journal_name: Cochrane Database of Systematic Reviews

publisher: Wiley

publisher_normalized: Wiley


title: Study of Prognostic Biomarkers of Survival at 6 Months for Patients Treated With Bevacizumab Glioblastomas in First Relapse After Failure of Radiochemotherapy

acronym: SPECTROBEVA

summary:
No predictive factors are known for the response to the bevacizumab anti-angiogenic molecule (Avastin) given in the event of relapse of glioblastoma (GBM) following radiochemotherapy. Classical MRI with gadolinium injection and perfusion is not sufficient to predict survival and response or duration. We propose to evaluate the prognostic interest for 6-month survival of spectroscopic biomarkers of proliferation, glial reaction, infiltration and glutaminergic metabolism or glycolytic metabolism recorded at 7 and 28 days of application of the treatment.

These biomarkers are based on the increase of an index combining choline / Creatine (Cho / Cr), Glx / Cr (Glutamine and glutamate / Creatine), NAA / Cr (N acetyl aspartate / Creatine) and lactate / Cr ratios. The long-term objective is to predict the survival of these relapsed GBM patients at an early stage and to identify responder patients who would benefit from this expensive molecule and avoid using it in non-responding patients


title: Behavior of Various Galenic Forms of a Probiotic in the Digestive Tract

acronym: PROBIOSIN

summary:
The aim of this study is to assess the behavior of a model probiotic strain, Lactobacillus salivarius, in the digestive tract of healthy volunteers and of ileostomized patients, depending on its galenic form.

Two classic forms will be tested (powder and pill). An innovative galenic form (pill with retarded release), developed to enhance intestinal viability and probiotic efficacy, will also be tested.


title: Evaluation of 4 MRI Methods (PDFF 3, 6 and 11 Gradient Echoes and Spectroscopy) Compared to the Reference Method (Liver Biopsy) in Quantification of Hepatic Steatosis

acronym: STEA-MRI

summary: Evaluation of 4 MRI methods (PDFF 3, 6 and 11 gradient echoes and Spectroscopy) compared to the reference method (liver biopsy) in quantification of hepatic steatosis


title: Hypermetabolism in the Elderly Lung Cancer Patient

acronym: HELP

summary: Aging and cancer are two conditions associated with extensive metabolic changes that can cause malnutrition. However, the clinical features and the underlying mechanisms leading to malnutrition are different in these two cases. We therefore wonder how age can influence the metabolic response to cancer.

ReferenceCitation: Ulmann G, Jouinot A, Tlemsani C, Curis E, Kousignian I, Neveux N, Durand JP, Goldwasser F, Cynober L, De Bandt JP. Lean Body Mass and Endocrine Status But Not Age Are Determinants of Resting Energy Expenditure in Patients with Non-Small Cell Lung Cancer. Ann Nutr Metab. 2019;75(4):223-230. doi: 10.1159/000504874. Epub 2019 Dec 19.

family: Ulmann

full_name: Guillaume Ulmann

given: Guillaume

family: Jouinot

full_name: Anne Jouinot

given: Anne

family: Tlemsani

full_name: Camille Tlemsani

given: Camille

family: Curis

full_name: Emmanuel Curis

given: Emmanuel

family: Kousignian

full_name: Isabelle Kousignian

given: Isabelle

family: Neveux

full_name: Nathalie Neveux

given: Nathalie

family: Durand

full_name: Jean-Philippe Durand

given: Jean-Philippe

family: Goldwasser

full_name: François Goldwasser

given: François

family: Cynober

full_name: Luc  Cynober

given: Luc

family: De Bandt

full_name: Jean-Pascal De Bandt

given: Jean-Pascal

journal_name: Annals of Nutrition and Metabolism

publisher: S. Karger AG

publisher_dissemination: S. Karger AG

publisher_group: S. Karger AG

publisher_normalized: S. Karger AG

lead_sponsor: University of Paris 5 - Rene Descartes


title: Kinetics of Serum β-D-glucan During Peritonitis With Candida in Resuscitation

summary: Intraabdominal fungal infections with Candida are constantly increasing. Their diagnosis and treatment is difficult. Morbidity and mortality are high. Β-D-Glucan has been proposed as a marker of systemic fungal infection in candidemia. Moreover, its kinetics is associated with therapeutic success. On the other hand, there are no data on intraabdominal infections that are much more frequent. The objective of the study is to evaluate the initial levels of β-D-glucan and its daily kinetics during the treatment of fungal peritonitis in resuscitation compared to a control group with a yeast-free peritonitis.

primary_purpose: Screening


title: Interest of Pulse Wave Velocity Measurement as a Predictor of Severity of Aortic Stenosis

acronym: VOPRABIO

summary: Aortic valve pathology is the third most common cardiovascular disease after coronary artery disease and hypertension, which is responsible for severe morbidity and mortality in elderly patients and requires surgical treatment in its most severe form of progression. The purpose of this study is to find a link between arterial stiffness and degenerative aortic stenosis. If this link is established, arterial stiffness may become a medical therapeutic target in order to delay the evolution of the disease.


title: SARCOLOWDOSE : Ultra-low Dose CT Scan and MRI in Thoracic Sarcoidosis

acronym: SARCOLOWDOSE

summary: The goal of this study is to evaluate the diagnostic agreement between, on the one hand, ultra-low dose CT and MRI with UTE pulse sequences, and on the other hand, standard CT scan, to quantify lung parenchyma patterns in thoracic sarcoidosis.

lead_sponsor: Rennes University Hospital


title: Evaluation of the Emergence of the Resistance to Linezolid in Staphylococcus Epidermidis and Risk Factors Analysis : a Mono-centric Case-control Study

acronym: ELiCSIR

summary:
Understanding the emergence of linezolid-resistance in Staphylococci has been allowed in the past years through the discovery of the clonal dissemination of a chromosomal cassette carrying a modified crf gene. New mutations have even been described. Though, clinical evidences are still lacking, especially concerning the factors associated to this emergence. It could seriously become quite problematic to eliminate one of the last therapeutic weapon at our disposal for the treatment of severe or complicated infections caused by resistant strains of Staphylococci and Enterococci.

We aim to describe the mechanisms that permitted to this resistance to become clinically significant, concerning meticillin-resistant Staphyloccocus epidermidis strains causing blood stream infections in ICU patients, and show the clinical risk factors associated with it through a case-control study on patients hospitalized in two ICUs of our hospital between 2011 and 2016.

time_perspective: Other

lead_sponsor: Centre Hospitalier Universitaire de Besancon


title: Contribution of the Perfusion Scanner in the Prediction of the Tumor Control of Patients With Hepatocellular Carcinoma Treated With Sorafenib.

acronym: HCC-CTPerf

summary:
Hepatocellular carcinoma (HCC) is a hypervascular tumor. The reference treatment of advanced forms of stage C according to the Barcelona classification (BCLC C) is sorafenib, a multi-target tyrosine kinase inhibitor with predominant anti-angiogenic action. In order not to underestimate the efficacy of sorafenib, scannographic evaluation of the tumor response should be performed with mRECIST criteria that are significantly better correlated with survival. These criteria take into account the tumor size and also the modification of the tumor contrast enhancement after anti-angiogenic treatment. It seems appropriate to evaluate tumor control rather than tumor response since sorafenib is more stable than tumor response.

This evaluation will be made according to the mRECIST criteria after 3 months of treatment since the progression-free survival is of the order of 3 to 4 months. The determination of early predictive criteria for the response to sorafenib would optimize the management of advanced HCCs. Indeed, sorafenib only improves overall survival by 3 months in selected patients, and with undesirable effects and a significant cost. Predictive biological criteria have already been studied, such as alpha foeto-protein (AFP), whose early decrease with sorafenib is associated with better overall survival. The same applies to the early reduction at 4-6 weeks of tumor arterial contrast according to mRECIST criteria. The perfusion scanner appears to be an accessible and reproducible choice imaging technique for assessing tumor vasculature. In metastatic kidney cancers, it was demonstrated that some criteria for tumor perfusion prior to treatment with sorafenib were predictive of better control of the disease and even a better tumor response according to the RECIST 1.1 criteria. The determination of pre-therapeutic tumor perfusion criteria in order to predict tumor control or even overall survival has never been studied in advanced CHCs. On the other hand, an early variation in the criteria for tumor perfusion under treatment would tend to be correlated with the tumor response and even with overall progression-free survival.

Therefore, the study of tumor vascularization by the perfusion scanner could make it possible to demonstrate early predictive criteria for tumor control under sorafenib in order to optimize the management of patients with advanced HCC.


title: Impact of a Feedback Device, CPRmeter®, on Chest Compression Quality Preservation During Cardio-pulmonary Resuscitation: A Manikin Study

acronym: CILICA-QS

summary:
Context: Chest compressions quality is known to be essential in cardiopulmonary resuscitation. Despite a known harmful effect of chest compressions interruptions, current guidelines still recommend provider switch every 2 minutes. Feedback impact on chest compressions quality preservation during cardiopulmonary resuscitation remains to be assessed.

Study design: simulated prospective monocentric randomized crossover trial.

Participants and methods: Sixty five professionals rescuers of the pre-hospital care unit of University Hospital of Caen (doctors, nurses and ambulance drivers) are enrolled to performed continuous chest compression on manikin (ResusciAnne®, Laerdal), twice, with and without a feedback device (CPRmeter®). Correct compression score (the main criterion) is defined by reached target of rate, depth and leaning at the same time (recorded continuously).

Hypothesis: Feedback device preserve chest compression quality above the 2 minutes recommended switch over during cardiopulmonary resuscitation.

lead_sponsor: University Hospital, Caen


title: Comparison of the Use of Energy Substrates and Hormonal Regulation of Blood Sugar During Exercise of Increasing Intensity Between Children With Type 1 Diabetes and Non-diabetic Control Children.

acronym: DIABSPORT

summary: The type 1 diabetes is a common chronic disease characterised by the stop of production of insulin by the pancreas. A lot of factors modify blood glucose. The objective is to study the effect of type 1 diabetes on the use of energy substrates (fats and carbohydrates) during exercise of increasing intensity by a comparison with non-diabetic controls children.


title: Connectivity and Social Cognition in Adolescent Girls With Borderline Personality Disorder, a Pilot Study

acronym: EEG-NIRS

summary: The disruption of social cognition associated with borderline personality disorder (BPD), and more specifically categorization of facial emotions, remains largely under-studied, despite the high frequency of this pathology in the clinical population. The first results differ from the observations made in adults and this confirms the relevance of studying this theme specifically in adolescence. On the cognitive level, there is a disturbance of the detection and the categorization of the facial emotions in the TPL. The characteristics of this disturbance and its possible association with an attack on the connectivity of the brain remain unknown in adolescence. No functional imaging studies are published in adolescent TPL. This pilot bimodal functional imaging study EEG-NIRS aims to collect preliminary and feasibility data to support a response to upcoming PHRC competitions and eventually offer a science thesis opportunity.


title: Prospective Follow-up of a Cohort of Patients With Aortic Valve Bicuspidia: Multicentre Study

summary: The aortic valve bicuspidia (BVA) is a congenital condition corresponding to the presence of 2 sigmoids instead of 3. This is the most common cardiac congenital anomaly affecting 0.5 to 2% of the population The general rule. BVA may be associated with structural damage to the ascending aorta, which exposes BVA patients to a risk of developing ascending aortic aneurysm and acute aortic accidents. Recent data from the literature have revealed that the natural history of BVA is marked by a possible development towards significant valvulopathy and / or an ascending aortic aneurysm often requiring surgical treatment. However, the natural history of bicuspid disease remains poorly understood and the prognostic factors for progression to severe valvulopathy and / or aneurysmal dilatation of the ascending aorta remain to be determined.