title: Medico-economic Evaluation of the Therapeutic Drug Monitoring of Anti-TNF Agents in the Management of Patients With Inflammatory Bowel Disease Treated With Anti-TNFalpha Biotherapy.

acronym: ATAIM

summary: Since their appearance more than a decade ago, anti-tumor necrosis factor (TNF) inhibitors have demonstrated beneficial activity in the treatment of inflammatory bowel diseases (IBD). However, more than one-third of patients present primary resistance, and one more third become resistant over time. One of the main factors associated with loss of response is the immunogenicity of anti-TNF biologics leading to the production of antibodies targetting the TNF inhibitor, namely anti-drug antibodies (ADAbs), that accelerate drug elimination from the serum and decrease its therapeutic activity. In this study the investigators propose a medico-economic evaluation of the measurement of anti-TNF agents and anti-drug antibodies serum concentrations in the management of patients with inflammatory bowel disease treated with anti-TNFalpha inhibitors. 280 patients with Crohn's disease (CD) or ulcerative colitis (UC) will be included and randomized in 2 groups with or without drug and ADAbs monitoring. In the monitored group, in case of loss of response, the clinician will use biological informations to adapt the treatment following a simple treatment algorithm. In the unmonitored group, drug and ADAbs measurements will not be transmitted to the clinician. Clinical and economical benefits of the biological monitoring will be evaluated after a follow-up period of two years.

ReferenceCitation: Baert F, Noman M, Vermeire S, Van Assche G, D' Haens G, Carbonez A, Rutgeerts P. Influence of immunogenicity on the long-term efficacy of infliximab in Crohn's disease. N Engl J Med. 2003 Feb 13;348(7):601-8. doi: 10.1056/NEJMoa020888.

ReferenceCitation: Bartelds GM, Wijbrandts CA, Nurmohamed MT, Stapel S, Lems WF, Aarden L, Dijkmans BA, Tak PP, Wolbink GJ. Clinical response to adalimumab: relationship to anti-adalimumab antibodies and serum adalimumab concentrations in rheumatoid arthritis. Ann Rheum Dis. 2007 Jul;66(7):921-6. doi: 10.1136/ard.2006.065615. Epub 2007 Feb 14.

ReferenceCitation: de Vries MK, Brouwer E, van der Horst-Bruinsma IE, Spoorenberg A, van Denderen JC, Jamnitski A, Nurmohamed MT, Dijkmans BA, Aarden LA, Wolbink GJ. Decreased clinical response to adalimumab in ankylosing spondylitis is associated with antibody formation. Ann Rheum Dis. 2009 Nov;68(11):1787-8. doi: 10.1136/ard.2009.109702. No abstract available.

ReferenceCitation: Lecluse LL, Driessen RJ, Spuls PI, de Jong EM, Stapel SO, van Doorn MB, Bos JD, Wolbink GJ. Extent and clinical consequences of antibody formation against adalimumab in patients with plaque psoriasis. Arch Dermatol. 2010 Feb;146(2):127-32. doi: 10.1001/archdermatol.2009.347.

ReferenceCitation: Ben-Horin S, Yavzori M, Katz L, Kopylov U, Picard O, Fudim E, Coscas D, Bar-Meir S, Goldstein I, Chowers Y. The immunogenic part of infliximab is the F(ab')2, but measuring antibodies to the intact infliximab molecule is more clinically useful. Gut. 2011 Jan;60(1):41-8. doi: 10.1136/gut.2009.201533. Epub 2010 Jun 2.

ReferenceCitation: Karmiris K, Paintaud G, Noman M, Magdelaine-Beuzelin C, Ferrante M, Degenne D, Claes K, Coopman T, Van Schuerbeek N, Van Assche G, Vermeire S, Rutgeerts P. Influence of trough serum levels and immunogenicity on long-term outcome of adalimumab therapy in Crohn's disease. Gastroenterology. 2009 Nov;137(5):1628-40. doi: 10.1053/j.gastro.2009.07.062. Epub 2009 Aug 5.

ReferenceCitation: Nanda KS, Cheifetz AS, Moss AC. Impact of antibodies to infliximab on clinical outcomes and serum infliximab levels in patients with inflammatory bowel disease (IBD): a meta-analysis. Am J Gastroenterol. 2013 Jan;108(1):40-7; quiz 48. doi: 10.1038/ajg.2012.363. Epub 2012 Nov 13.

ReferenceCitation: Vande Casteele N, Gils A, Singh S, Ohrmund L, Hauenstein S, Rutgeerts P, Vermeire S. Antibody response to infliximab and its impact on pharmacokinetics can be transient. Am J Gastroenterol. 2013 Jun;108(6):962-71. doi: 10.1038/ajg.2013.12. Epub 2013 Feb 19.

ReferenceCitation: Steenholdt C, Svenson M, Bendtzen K, Thomsen OO, Brynskov J, Ainsworth MA. Severe infusion reactions to infliximab: aetiology, immunogenicity and risk factors in patients with inflammatory bowel disease. Aliment Pharmacol Ther. 2011 Jul;34(1):51-8. doi: 10.1111/j.1365-2036.2011.04682.x. Epub 2011 May 3.

ReferenceCitation: Afif W, Loftus EV Jr, Faubion WA, Kane SV, Bruining DH, Hanson KA, Sandborn WJ. Clinical utility of measuring infliximab and human anti-chimeric antibody concentrations in patients with inflammatory bowel disease. Am J Gastroenterol. 2010 May;105(5):1133-9. doi: 10.1038/ajg.2010.9. Epub 2010 Feb 9.

ReferenceCitation: Bartelds GM, Krieckaert CL, Nurmohamed MT, van Schouwenburg PA, Lems WF, Twisk JW, Dijkmans BA, Aarden L, Wolbink GJ. Development of antidrug antibodies against adalimumab and association with disease activity and treatment failure during long-term follow-up. JAMA. 2011 Apr 13;305(14):1460-8. doi: 10.1001/jama.2011.406.

ReferenceCitation: Steenholdt C, Brynskov J, Thomsen OO, Munck LK, Fallingborg J, Christensen LA, Pedersen G, Kjeldsen J, Jacobsen BA, Oxholm AS, Kjellberg J, Bendtzen K, Ainsworth MA. Individualised therapy is more cost-effective than dose intensification in patients with Crohn's disease who lose response to anti-TNF treatment: a randomised, controlled trial. Gut. 2014 Jun;63(6):919-27. doi: 10.1136/gutjnl-2013-305279. Epub 2013 Jul 22.

ReferenceCitation: Velayos FS, Kahn JG, Sandborn WJ, Feagan BG. A test-based strategy is more cost effective than empiric dose escalation for patients with Crohn's disease who lose responsiveness to infliximab. Clin Gastroenterol Hepatol. 2013 Jun;11(6):654-66. doi: 10.1016/j.cgh.2012.12.035. Epub 2013 Jan 26.

ReferenceCitation: Paul S, Del Tedesco E, Marotte H, Rinaudo-Gaujous M, Moreau A, Phelip JM, Genin C, Peyrin-Biroulet L, Roblin X. Therapeutic drug monitoring of infliximab and mucosal healing in inflammatory bowel disease: a prospective study. Inflamm Bowel Dis. 2013 Nov;19(12):2568-76. doi: 10.1097/MIB.0b013e3182a77b41.

ReferenceCitation: Roblin X, Marotte H, Rinaudo M, Del Tedesco E, Moreau A, Phelip JM, Genin C, Peyrin-Biroulet L, Paul S. Association between pharmacokinetics of adalimumab and mucosal healing in patients with inflammatory bowel diseases. Clin Gastroenterol Hepatol. 2014 Jan;12(1):80-84.e2. doi: 10.1016/j.cgh.2013.07.010. Epub 2013 Jul 23.

collaborators: Department of the medical information of Montpellier

appel_a_projets: PRME

region: Occitanie

nom_etablissement: CHU MONTPELLIER

type_etablissement: CH

acronyme: ATAIM

titre: Evaluation médico-économique de l'intérêt du dosage sérique du médicament anti-TNF et des anticorps anti-médicament dans la prise en charge des patients atteints de maladie inflammatoire chronique de l'intestin traités par anti-TNFalpha. Etude multicentrique randomisée de type médico-économique.

discipline_principale: gastro-entérologie

nom_porteur: Vincent

prenom_porteur: Thierry


title: Multicenter and Open Pilot Clinical Study on the Safety of a New One-piece Convex Appliance in Patients With Enterostomy

summary: This study evaluates the performance of a new 1-piece ostomy convex appliance in patients with enterostomy.

status: Completed

study_completion_date_type: Actual

study_type: Interventional

primary_purpose: Treatment

enrollment_type: Actual

lead_sponsor: BBraun Medical SAS

intervention_type: Device

lead_sponsor_type: industriel

status_simplified: Completed


acronym: E-NOSE

summary: The main goal of the study is demonstrate that e-Nose system function is not altered in weightlessness and more specifically that gas concentration measurements are the same in weightlessness and normal gravity.

status: Unknown status

study_completion_date_type: Anticipated

primary_purpose: Basic Science

enrollment_type: Anticipated

lead_sponsor: University Hospital, Caen

intervention_type: Other

lead_sponsor_type: academique

status_simplified: Unknown


acronym: Massper

summary:
Parabolic flight is the only ground-based condition in which free-fall (0G) can be created long enough for safely testing changes in human perception and behavior. In addition to the 0G period, parabolic flight generates equal duration periods of 1.8G, which present another unique opportunity to test the same responses to hypergravity and back to 1G.

It is well known that performance decrements occur in astronauts during and after gravity level transitions. Illusions are commonly felt in orbit as well disorientation and perceptual limitations, mainly due to both psycho-physiological changes and adaptation and lack of familiar points of reference in the space environment. Studies performed during previous space missions showed several changes occurring in different gravity conditions, pointing out, for example, that colors and shadows were misleading, the depth and distance perception were weakened, and the linear perspective was lost. Visual perception is of primary importance for spatial orientation and object recognition because the static vestibular (otolithic) and proprioceptive signals are absent when free-floating. Consequently, astronauts become increasingly dependent on vision to perceive motion and orientation. All these factors play an important role in the adaptation of humans to spaceflight that needs to be analyzed to understand the underlying mechanisms that regulate human psycho-physiological adaptive process to changing gravity. Human psycho-physiological health has to be safeguarded and possibly improved when long-term human space missions are programmed in the near future.

The primary objective of this experiment is to investigate if the SWI illusion is present in altered gravity environments. Since weight cannot be estimated in 0G, investigators have developed a procedure during which the subject is asked to estimate the objects' mass by shaking them rather than lifting them. Our results in 1G indicate that a size-mass illusion (SMI) is also present in 1G. Our hypothesis is that the previously observed alteration in 3D visual perception in 0G, particularly in the height of 3D objects, as well as the change in proprioceptive inputs, will be responsible for changes in the SMI in 0G and 1.8G compared to 1G. In a separate proposal, investigators will also propose to perform this experiment using the ESA short-arm human centrifuge (SAHC), with subjects exposed to various centrifugal force levels, to further investigate the role of proprioceptive cues in the size-mass illusion.


title: Post Market Clinical Follow-Up Study Protocol for PROFEMUR® Am Femoral Components and PROCOTYL® O HA Coated Acetabular Components

summary: MicroPort Orthopedics (MPO) is conducting this post market clinical follow-up (PMCF) study to evaluate the safety and efficacy of its total hip arthroplasty (THA) and resurfacing components marketed in the European Union (EU). These types of studies are required by regulatory authorities for all THA and resurfacing devices that do not have medium to long-term clinical evidence available at the time of gaining approval to market in the EU. This study has been designed in accordance with the medial device directives (MEDDEV) 2.12/2 rev 2.

study_start_date_type: Anticipated

status: Withdrawn

study_type: Observational

time_perspective: Prospective

ipd_sharing: No

lead_sponsor: MicroPort Orthopedics Inc.


title: Evaluation of Physiological and Biomechanical Efficiency of the PAPAW

acronym: SmartDrive

summary:
The main objective is to quantify energy expenditure when using the SmartDrive system during manual wheelchair propulsion in external conditions (slope, straight line). For this two comparisons are performed:

Comparison of energy expenditure with and without the use of a system SmartDrive 6 minute propulsion test.

Comparison the risk of musculoskeletal disorders of the wrist during a 6 minute propulsion test.

study_start_date_type: Actual

design_allocation: Randomized

primary_purpose: Other

lead_sponsor: Centre d'Investigation Clinique et Technologique 805


title: Observational Study of the Analgesic Effect of Treatment With rTMS in Patients Suffering From Chronic Neuropathic Pain Refractory to Conventional Treatment and Monitored and Evaluated in Consultation Multidisciplinary Chronic Pain in Lower Normandy

acronym: rTMSDOULNEURO

summary:
For ten years, rTMS, repetitive transcranial magnetic stimulation of the motor cortex, has found its place in the treatment of drug-resistant neuropathic pain. Patients relieved by some sessions may thereafter receive a chronic invasive stimulation via electrodes implanted through a neurosurgical procedure. This is common practice at the University Hospital of Caen and in different CHU with the proper equipment rTMS. It seems permissible to provide in our center only a non-invasive technique for patients challenged with brain surgery, since according to the various meta-analyzes the analgesic efficacy of rTMS seems to be correlated to the repetition of sessions.

Assessment centers and the treatment of pain allow a multidimensional assessment, bio-psycho-social of patients in order to optimize their management and experience efficiently analgesics first- and second-line.

We propose a study evaluating the analgesic efficacy of rTMS, in relevant stimulation parameters reproduced according to a literature review, during 3 months after 5 active sessions separated by one week apart, in 15 patients with neuropathic pain chronic refractory to treatment of first and second line, followed by multidisciplinary center specializing in chronic pain Lower Normandy. The quality of life will also be assessed by validated scales, and the results will be compared to the literature data.

location_facility: Centre d'évaluation et de traitement de la douleur (CETD)


title: Contribution of an Endermologie LPG Cellu M6 Treatment in the Treatment Pathway of Patients Suffering From a Breast Cancer Related Lymphoedema, During an Intensive Decongestive Treatment.

acronym: ELOCS

summary: This study will assess the benefit of LPG Cellu M6 in addition of intensive decongestive treatment in reducing secondary lymphoedema in breast cancer.

ReferenceType: background

ReferenceCitation: Lawenda BD, Mondry TE, Johnstone PA. Lymphedema: a primer on the identification and management of a chronic condition in oncologic treatment. CA Cancer J Clin. 2009 Jan-Feb;59(1):8-24. doi: 10.3322/caac.20001.

ReferenceCitation: Karki A, Anttila H, Tasmuth T, Rautakorpi UM. Lymphoedema therapy in breast cancer patients: a systematic review on effectiveness and a survey of current practices and costs in Finland. Acta Oncol. 2009;48(6):850-9. doi: 10.1080/02841860902755251.

ReferenceCitation: Mayrovitz HN. The standard of care for lymphedema: current concepts and physiological considerations. Lymphat Res Biol. 2009;7(2):101-8. doi: 10.1089/lrb.2009.0006.

ReferenceCitation: Vignes S, Porcher R, Arrault M, Dupuy A. Long-term management of breast cancer-related lymphedema after intensive decongestive physiotherapy. Breast Cancer Res Treat. 2007 Mar;101(3):285-90. doi: 10.1007/s10549-006-9297-6. Epub 2006 Jul 7.

lead_sponsor: University Hospital, Toulouse

sponsor_collaborators:
University Hospital, Toulouse
LPG SYSTEMS

intervention_type: Procedure


type: Registry Identifier

title: Evaluation of Perioperative Use of Hypnosis in Pediatric Surgery: Clinical and Medico-economic Interests

summary:
In adults, it is common to perform a number of superficial and non invasive surgeries under local anesthesia in order to limit the use of general anesthesia.

Hypnosis is a nonpharmacological therapies that can be used during surgery to improve the patient comfort and experience. The benefit of this practice has been widely demonstrated in adults, decreasing perioperative anxiety, postoperative pain scores as well as nausea and vomiting.

In pediatric surgery, hypnosis is an effective technique for the management of preoperative anxiety. It is used by many teams in their daily practice, particularly during anesthetic induction.

For 2 years, the team of pediatric anesthesia and surgery of the Montpellier University Hospital also offers for selected short and superficial non-invasive surgeries, an intraoperative management under hypnosis in association with ocal anesthesia as an alternative to general anesthesia. If this clinical practice of hypnosis is fully accepted and recognized in our intraoperative surgical unit, to date, no studies have evaluated the benefits of this technique compared to general anesthesia.

The objective of the study is to compare the impact of these techniques (hypnosis vs. general anesthesia) on postoperative experiences of children (rehabilitation time, anxiety, pain, nausea and vomiting, negative behavioral disorders).

primary_purpose: Supportive Care

lead_sponsor: University Hospital, Montpellier

intervention_type: Drug


title: ARTEMIS Synovial Markers in Arthritis Childhood

acronym: ARTEMIS

summary: The aim of this study is to find markers that could differentiate infectious and inflammatory arthritis. The investigators want to find markers by differential analysis by compare synovial fluids of septic and inflammatory arthritis. The investigators will use for this analysis, proteomics, cytokine dosage and monocyte typing by flow cytometry analysis. The investigators will use one marker or a score with biological and clinical data to discriminate arthritis of infectious and inflammatory etiology.

design_allocation: Non-Randomized

primary_purpose: Diagnostic

ReferenceType: result

ReferenceCitation: Nziza N, Jeziorski E, Delpont M, Cren M, Chevassus H, Carbasse A, Mahe P, Abassi H, Joly-Monrigal P, Schordan E, Mange A, Jorgensen C, Apparailly F, Duroux-Richard I. Synovial-Fluid miRNA Signature for Diagnosis of Juvenile Idiopathic Arthritis. Cells. 2019 Nov 26;8(12):1521. doi: 10.3390/cells8121521.

oa_colors: green gold

oa_host_type: publisher;repository

evidence: oa journal (via doaj)

host_type: publisher

license: cc-by

license_normalized: cc-by

version: publishedVersion

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

host_type: repository

repository_institution: PubMed Central - Europe PMC

repository_normalized: PubMed Central

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Diderot

repository_normalized: HAL

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Université de Nantes

evidence: oa repository (via pmcid lookup)

license_normalized: no license

repositories:
HAL
PubMed Central

repositories_concat: HAL;PubMed Central

unpaywall_oa_status: gold

publisher_dissemination: MDPI

ReferenceCitation: Cren M, Nziza N, Carbasse A, Mahe P, Dufourcq-Lopez E, Delpont M, Chevassus H, Khalil M, Mura T, Duroux-Richard I, Apparailly F, Jeziorski E, Louis-Plence P. Differential Accumulation and Activation of Monocyte and Dendritic Cell Subsets in Inflamed Synovial Fluid Discriminates Between Juvenile Idiopathic Arthritis and Septic Arthritis. Front Immunol. 2020 Jul 31;11:1716. doi: 10.3389/fimmu.2020.01716. eCollection 2020.

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Inserm

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Inria

publisher_dissemination: Frontiers


title: Treatment of Pleural Effusion by Routine Thoracic Ultrasound

acronym: ECHOPLEV

summary: The main objective of the study is to assess the cost-effectiveness ratio of two management strategies of pleurisy in adults : a strategy by systematic thoracic ultrasound versus a strategy without thoracic ultrasound.

ReferenceCitation: Havelock T, Teoh R, Laws D, Gleeson F; BTS Pleural Disease Guideline Group. Pleural procedures and thoracic ultrasound: British Thoracic Society Pleural Disease Guideline 2010. Thorax. 2010 Aug;65 Suppl 2:ii61-76. doi: 10.1136/thx.2010.137026. No abstract available.

ReferenceCitation: Reissig A, Copetti R, Mathis G, Mempel C, Schuler A, Zechner P, Aliberti S, Neumann R, Kroegel C, Hoyer H. Lung ultrasound in the diagnosis and follow-up of community-acquired pneumonia: a prospective, multicenter, diagnostic accuracy study. Chest. 2012 Oct;142(4):965-972. doi: 10.1378/chest.12-0364.

ReferenceCitation: Jones PW, Moyers JP, Rogers JT, Rodriguez RM, Lee YC, Light RW. Ultrasound-guided thoracentesis: is it a safer method? Chest. 2003 Feb;123(2):418-23. doi: 10.1378/chest.123.2.418.

ReferenceCitation: Ikezoe J, Morimoto S, Arisawa J, Takashima S, Kozuka T, Nakahara K. Percutaneous biopsy of thoracic lesions: value of sonography for needle guidance. AJR Am J Roentgenol. 1990 Jun;154(6):1181-5. doi: 10.2214/ajr.154.6.2110724.

ReferenceCitation: Chen HJ, Yu YH, Tu CY, Chen CH, Hsia TC, Tsai KD, Shih CM, Hsu WH. Ultrasound in peripheral pulmonary air-fluid lesions. Color Doppler imaging as an aid in differentiating empyema and abscess. Chest. 2009 Jun;135(6):1426-1432. doi: 10.1378/chest.08-2188. Epub 2009 Mar 2.


title: Efficacy of Preoperative Re-education on Patients With an Anterior Cruciate Ligament Rupture: a Randomized Controlled Trial

acronym: PRELIG

summary:
Anterior cruciate ligament (ACR) rupture is a common lesion of sportsmen that leads to functional deficits which are difficult to overcome. To prevent from an unfavorable evolution, patients can either get a non-surgical treatment or an ACR surgery, which is very common. Knee functional performance level could impact on the postoperative outcome and it's of common knowledge that early re-education after an ACR rupture improves knee functioning.

Patients with an ACR rupture enrolled in this study will be randomized either in an experimental group (with preoperative reeducation) or in a control group (without preoperative reeducation). Both groups will then have post-operative re-education (40 sessions) based on HAS recommendations.

The main aim of this study is to assess the impact of preoperative re-education on knee functional performance 4 month after surgical reconstruction of an ACR.

Secondary aims are to determine the impact of the 4-week preoperative re-education on knee functional performance after an ACR rupture, before surgery and 7 months after surgery.

Functional performance, muscular strength, proprioception and anterior knee laxity will be measured at inclusion (V0), 4-5 days before surgery (V1), 4 month (V4M) and 7 months (V7M) after surgery. Lysholme-Tegner scoring and IKDC2000 questionnaire will be added to the previous assessments.

lead_sponsor: University Hospital, Clermont-Ferrand

intervention_type: Behavioral


title: Pharmacokinetics of Ertapenem Following Subcutaneous or Intravenous Infusion in Patients Aged Over 75 (PHACINERTA)

acronym: PHACINERTA

summary:
In geriatric departments, physicians are faced with two difficulties, first the increasing number of infections caused by multiresistant bacteria, especially extended spectrum β-lactamase (ESBL) producing enterobacteria strains and second, the poor venous access frequently encountered in elderly population. Giving antibiotics subcutaneously would be an interesting alternative, all the more as intramuscular injection is contraindicated in case the of anticoagulant therapy. Unfortunately, few data are available about subcutaneous (SC) administration. Ertapenem is a recent long-acting parenteral carbapenem indicated especially in the treatment of ESBL infection. Its subcutaneously administration has been tested in several studies in Intensive Care Units (ICU) and internal medicine wards with promising results regarding clinical and pharmacokinetics data.

An alternative to the IV Ertapenem administration is needed because of poor venous access and behavioural abnormalities commonly present in infected elderly population. Ertapenem is currently SC administrated in geriatric departments if no other option is available. Moreover elderly patients often present several comorbdities, polymedication, renal insufficiency, cachexia which may disturb antibiotics pharmacokinetics.

The aim of the study is to obtain pharmacokinetic data of SC and IV Ertapenem administration in elderly population, obtain PK/PD parameters adapted to time-dependent antibiotics (T%>MIC) and descriptive data of occurrence of adverse effects and evolution of signs of infection.

ReferenceType: derived

ReferenceCitation: Roubaud Baudron C, Legeron R, Ollivier J, Bonnet F, Greib C, Guerville F, Cazanave C, Kobeh D, Cressot V, Moneger N, Videau MN, Thiel E, Foucaud C, Lafargue A, de Thezy A, Durrieu J, Bourdel Marchasson I, Pinganaud G, Breilh D. Is the subcutaneous route an alternative for administering ertapenem to older patients? PHACINERTA study. J Antimicrob Chemother. 2019 Dec 1;74(12):3546-3554. doi: 10.1093/jac/dkz385.

oa_host_type: closed

repositories_concat: closed

publisher_dissemination: Oxford University Press

lead_sponsor: University Hospital, Bordeaux


title: Comparaison Biochimique et Histologique Des Cartilages Nasal et Auriculaire Chez le fœtus et le Nouveau-né Porteur de Fente Labiale

acronym: CARTOON

summary:
We seek to compare biochemically and histologically the nasal cartilage and ear in the newborn cleft lip and slot carrier in order to improve the quality of care and patient comfort after surgery of cheilorhinoplasty which is the primary treatment slots .

The concentration of hyaluronic acid as well as in type 1 collagen and 3 are assayed by immunohistochemistry and study of mRNA and then they are compared according to the type of cartilage.

This comparison is done on nasal cartilage samples and atrial newborns holders of cleft lip and operated in the neonatal period.

Given the difficulty and constraint of time it takes to reach the 20 subjects of our study , we will also add to our population the stillborn babies before 25SA and newborns who die before the age of 28 days and having had an autopsy.


title: A Randomized Double-blind Clinical Trial on the Efficacy of Transcranial Direct Current Stimulation (tDCS) in Reducing Alcohol Consumption in Non-abstinent Patients With Alcohol Use Disorder

acronym: REDSTIM

summary: The study evaluates the efficacy of 1 week of tDCS (5 sessions) placebo in reducing alcohol consumption within the 24 weeks following the treatment in non-abstinent patients with alcohol use disorders versus placebo.

ReferenceCitation: Trojak B, Soudry-Faure A, Abello N, Carpentier M, Jonval L, Allard C, Sabsevari F, Blaise E, Ponavoy E, Bonin B, Meille V, Chauvet-Gelinier JC. Efficacy of transcranial direct current stimulation (tDCS) in reducing consumption in patients with alcohol use disorders: study protocol for a randomized controlled trial. Trials. 2016 May 17;17(1):250. doi: 10.1186/s13063-016-1363-8.

repositories_concat: PubMed Central

publisher_dissemination: Springer-Nature

lead_sponsor: Centre Hospitalier Universitaire Dijon


title: Impact of Complementary Medicine Techniques (Therapeutic Touch and Hypno Analgesia) on the Term of Delivery of Patients Hospitalized for Preterm Labor (Hypnorelax)

acronym: Hypnorelax

summary:
The threat of premature birth (MAP) is the leading cause of hospitalization during pregnancy complicated by preterm delivery in 5-10% of cases in developed countries. Psychological stress that encompasses anxiety and anxiety resounding including sleep quality can be a work of preacher and premature delivery.

Preterm birth before 37 has an impact on the survival and health of the newborn. It is the leading cause of mortality and obstetric complications. It has a cost both for the newborn, the term parturient health but also the financial cost by the management before delivery and the consequences of a premature birth.

The usual management of MAP is hospitalized with tocolysis, monitoring and rest. The hospitalization and invasive procedures contribute to increasing stress. It therefore seems necessary to seek to diversify and master reputable techniques for their effectiveness on mastering stress and improving sleep quality as hypnosis and feel relaxing.

Hypnosis in obstetrics is used primarily to control pain, nausea and postpartum depression. It also reduces preoperative anxiety and during induction of anesthesia, as well as behavioral disorders during the first postoperative week. Hypnosis can play an important role in the prevention of preterm birth. In a non-randomized study, hypnosis combined with drug therapy has prolonged pregnancy of patients followed in high risk pregnancy.

The relaxing touch brings relaxation and well being. In obstetrics, it has an influence on the anti-stress hormones and plays a role in reducing pain during childbirth.

Few studies interested in hypnosis and relaxation therapies in pregnant women, especially in case of MAP. The published data relate to a small number of patients and a low level of evidence. Although there seems promising results, prospective studies are needed to conclude its effectiveness in improving the stress, pain or other parameters.

Health workers trained in these techniques could observe during their production improved sleep disorders, stress, better communication between doctor and patient. Moreover, these treatments could induce an improvement in the overall care of patients, and therefore have an impact on the continuation of pregnancy.

These findings are based on these hypothesis. There is a clinical gain the contribution of hypnosis and relaxing touch in women hospitalized for MAP before 32 weeks of gestation. This would, among other improvements in sleep disorders and stress, decrease pain, and acting on the extension of the term of pregnancy in women followed by these techniques and a decrease in hospitalizations of newborns premature neonatology and neonatal intensive care units.

primary_purpose: Prevention

lead_sponsor: Assistance Publique - Hôpitaux de Paris

appel_a_projets: PHRIP

region: Île-de-France

nom_etablissement: ASSISTANCE PUBLIQUE-HOPITAUX DE PARIS

type_etablissement: CHUR

acronyme: HYPNORELAX

titre: Impact des techniques de médecines complémentaires (toucher thérapeutique et hypno analgésie) sur le terme d'accouchement des patientes hospitalisées pour menace d'accouchement prématuré (MAP)

discipline_principale: obstétrique

nom_porteur: PERRUDIN

prenom_porteur: Céline


title: Study of Platelet Activation by Severe Aortic Stenosis and Its Correction by Transcatheter Aortic Valve Implantation (TAVI) Platelet Activation in TAVI

acronym: TAVI

summary: Study of platelet activation by severe aortic stenosis and its correction by Transcatheter Aortic Valve Implantation (TAVI)

sponsor_collaborators:
University Hospital, Toulouse
Medtronic


acronym: FLASH

summary: The primary purpose of the study is to evaluate whether the type of fluid (0.9% saline or 6% Hydroxyethyl starch 130/0.4) in the context of an individualized goal-directed fluid therapy is associated with a difference in morbidity and mortality within the first 14 days in patients at moderate-to-high risk of postoperative complications after abdominal surgery.

ReferenceCitation: Futier E, Garot M, Godet T, Biais M, Verzilli D, Ouattara A, Huet O, Lescot T, Lebuffe G, Dewitte A, Cadic A, Restoux A, Asehnoune K, Paugam-Burtz C, Cuvillon P, Faucher M, Vaisse C, El Amine Y, Beloeil H, Leone M, Noll E, Piriou V, Lasocki S, Bazin JE, Pereira B, Jaber S; FLASH Trial Group; Lasocki S, Huet O, Cadic A, Jacob C, Paugam-Burtz C, Restoux A, Ouattara A, Feitita I, Deloge E, Defaye M, Joannes-Boyau O, Carles P, Napolitano G, Monziols S, Futier E, Vignaud M, Paul S, Gahbiche K, Fayon J, Laroche E, Bazin JE, Brandely A, Le Moal C, Lebuffe G, Garot M, Piriou V, Jaber S, Chanques G, Verzilli D, De Jong A, Millot A, Castagnoli A, Leone M, Pastene B, Castelli C, Medam S, Velly L, Vaisse C, Faucher M, Asehnoune K, Samba E, Roquilly A, Le Penndu M, Cuvillon P, Yves Lefrant J, Wira O, Dubout E, Mfam WS, Lescot T, Begneu E, Burey J, Cirilovic T, Beloeil H, Allo G, Pottecher J, Lebas B, Venot C, Rameau JP, Dimache F, Leger PS, El Amine Y. Effect of Hydroxyethyl Starch vs Saline for Volume Replacement Therapy on Death or Postoperative Complications Among High-Risk Patients Undergoing Major Abdominal Surgery: The FLASH Randomized Clinical Trial. JAMA. 2020 Jan 21;323(3):225-236. doi: 10.1001/jama.2019.20833.

oa_colors: green other

evidence: open (via free pdf)

version: submittedVersion

repository_institution: CCSD (Centre pour la Communication Scientifique Directe) - HAL - Nantes Université

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - SHS

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Artxiker

repositories_institution: Le Centre pour la Communication Scientifique Directe - HAL - Diderot

unpaywall_oa_status: bronze

publisher_dissemination: American Medical Association

ReferenceCitation: Futier E, Biais M, Godet T, Bernard L, Rolhion C, Bourdier J, Morand D, Pereira B, Jaber S; FLASH trial management committee. Fluid loading in abdominal surgery - saline versus hydroxyethyl starch (FLASH Trial): study protocol for a randomized controlled trial. Trials. 2015 Dec 21;16:582. doi: 10.1186/s13063-015-1085-3.

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - memSIC

sponsor_collaborators: Agence Nationale de sécurité du Médicament

sponsor_collaborators: Programme Hospitalier de Recherche Clinique (AOI N° 2013 _ Futier)

sponsor_collaborators: Société Française Anesthesie-Réanimation (SFAR)

title: Fluid Loading in Abdominal Surgery: Saline Versus Hydroxyethyl Starch: A Double-blinded Multicenter Prospective Randomized Trial (FLASH Study)

type: EudraCT Number

source: euctr


title: Study of Anti-glycan Antibodies Stability in Saint-Etienne IBD Cohort - A Monocentric Study

summary: Prognostic factors in Inflammatory Bowel Diseases (IBD) are currently mainly based on clinical factors (disease extension, perianal involvement, need for surgery, use of immunomodulators…). All of immunological markers (or serological) of IBD have a diagnostic role in indeterminate colitis (ulcerative colitis vs crohn's disease) but they never have been considered as predictors of IBD course in adults. Among the most used, anti-neutrophil cytoplasm antibodies (ANCA) and Anti-Saccaromyces cerevisiae antibodies (ASCA) allow the distinction between ulcerative colitis (ANCA+/ASCA-) and Crohn's disease (ANCA-/ASCA+), and their combined use has a sensitivity and a specificity of about 85%. However, 10 other antibodies have been identified and recently evaluated individually in IBD and especially in pediatric Crohn's disease: anti-ompC, anti-I2, anti-flagellins, anti-glycan (anti-laminaribioside carbohydrate antibodies (ALCA), anti-mannobioside carbohydrate antibodies (AMCA), anti-chitobioside carbohydrate antibody (ACCA), anti-chitin and anti-laminarin), anti-goblet cells and anti-C.albicans specific mannans antibodies. These complementary tests improve the reliability of the diagnosis. In a previous cross-sectional work on a cohort of 195 IBD patients, the investigator showed a prognostic role of some of anti-glycan Abs and especially a correlation with a pejorative form of the disease both in Crohn's disease than in Ulcerative Colitis (UC) and a prediction of corticodependency in IBD.

lead_sponsor: Centre Hospitalier Universitaire de Saint Etienne


title: Cellular and Molecular Adaptations to Exercise-induced Inflammatory Response in Children With Autoimmune Diseases

acronym: AJI-APA

summary: Juvenile idiopathic arthritis (JIA) is a chronic disease characterized by persistent joint inflammation. The immune system disruption that leads to overproduction of pro-inflammatory cytokines (TNF-α, IL-1, IL-6) is a cascade of events on different levels-some molecular, some cellular, and some systemic. Our objective is to identify the mechanisms through which physical activity is liable to mediate inflammatory balance in autoimmune disease settings, and specifically in JIA patients.


type: Other Identifier

title: Study of the Colonic Carriage of Staphylococcus Aureus in a Prospective Cohort of Patients Undergoing Endoscopic Screening for Digestive Cancer in the University Hospital of Saint-Etienne.

acronym: ColoStaph

summary: Epidemiological study aiming to describe the carriage (nasal, throat, groin, rectal and colonic) of S. aureus in patients without chronic digestive disease who are going to have a colonoscopy for cancer screening. The carriage will be analyzed globally and the similarity of strains isolated from each site will be analyzed using molecular tools. The aim of this study is to better estimate the digestive reservoir of S. aureus to better prevent endogenous infections due to this bacterium.

sponsor_collaborators: Centre Hospitalier Universitaire de Saint Etienne


title: PRODIGE 33 - BALLAD - Phase III Trial Investigating the Potential Benefit of Adjvant Chemotherapy for Small Bowel Adenocarcinoma

acronym: BALLAD

summary:
The utility of adjuvant chemotherapy in the management of Small Bowel Adenocarcinoma (SBA) remains unproven and awaits the results of a large, global, prospective, phase III, randomised, controlled trial. Across the 830 million population of North America and Europe, there are approximately 3,000 patients with stage I-III SBA every year who would be potentially eligible for such an adjuvant chemotherapy trial.

Given the absence of good-quality and evidence-based data, it has been agreed that a trial considering adjuvant chemotherapy versus no chemotherapy was appropriate for patients with stage I-III SBA in whom the oncologist and patient feel that the benefit of adjuvant chemotherapy is uncertain. For those patients with stage I-III SBA who, with their oncologists, feel that the potential benefit of adjuvant chemotherapy is certain (and hence are not willing to accept randomisation to the 'no chemotherapy' arm), a randomisation between single agent fluoropyrimidine versus doublet fluoropyrimidine and oxaliplatin chemotherapy will be offered. Tumour stage will be used as a stratification factor. Those patients who do not consent to be randomised will be offered registration to allow collection of demographic, clinicopathological and survival data, thereby making optimal use of the rare patient population available. In addition, archival Formalin Fixed Paraffin Embedded (FFPE) tissue and contemporaneous venous blood samples will be collected from every registered patient to allow molecular profiling and future translational research. A questionnaire about underlying risk factors (e.g. Crohn's disease, coeliac disease, Lynch syndrome etc) will be completed along with the other collected data on all registered patients.

ReferenceCitation: Kitahara H, Honma Y, Ueno M, Kanemitsu Y, Ohkawa S, Mizusawa J, Furuse J, Shimada Y; Colorectal Cancer Study Group and Hepatobiliary and Pancreatic Oncology Group of the Japan Clinical Oncology Group. Randomized phase III trial of post-operative chemotherapy for patients with stage I/II/III small bowel adenocarcinoma (JCOG1502C, J-BALLAD). Jpn J Clin Oncol. 2019 Mar 1;49(3):287-290. doi: 10.1093/jjco/hyy188.


title: Comparaison du Pied Bionique Proprio-Foot® Versus le Pied Habituel Chez Les amputés Tibiaux

acronym: PROPRIO-FOOT

summary: Evaluate a new porosthetic device in lower limb amputees.

lead_sponsor: University Hospital, Angers


title: Natural History of Cardiac and Respiratory Function in Patients With Muscular Dystrophies on Home Mechanical Ventilation

summary: Muscular dystrophies are inherited disorders that affect skeletal muscle. Cardiac and respiratory function may be affected in this group of diseases. The investigators sought to analyze the long term cardiac and respiratory function in patients with muscular dystrophies recquiring home mechnaical ventilation .

time_perspective: Retrospective

ReferenceCitation: Fayssoil A, Lazarus A, Wahbi K, Ogna A, Nardi O, Lofaso F, Clair B, Orlikowski D, Annane D. Cardiac implantable electronic devices in tracheotomized muscular dystrophy patients: Safety and risks. Int J Cardiol. 2016 Nov 1;222:975-977. doi: 10.1016/j.ijcard.2016.08.040. Epub 2016 Aug 6.

publisher_dissemination: Elsevier

ReferenceCitation: Fayssoil A, Ogna A, Chaffaut C, Chevret S, Guimaraes-Costa R, Leturcq F, Wahbi K, Prigent H, Lofaso F, Nardi O, Clair B, Behin A, Stojkovic T, Laforet P, Orlikowski D, Annane D. Natural History of Cardiac and Respiratory Involvement, Prognosis and Predictive Factors for Long-Term Survival in Adult Patients with Limb Girdle Muscular Dystrophies Type 2C and 2D. PLoS One. 2016 Apr 27;11(4):e0153095. doi: 10.1371/journal.pone.0153095. eCollection 2016.

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Université de Bretagne Occidentale

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - INSU

evidence: oa repository (semantic scholar lookup)

repositories:
HAL
PubMed Central
pdfs.semanticscholar.org

publisher_dissemination: Public Library of Science

sponsor_collaborators: Centre d'Investigation Clinique et Technologique 805


acronym: CMHStress

summary: Hypertrophic cardiomyopathy (HCM) is a primitive myocardic disease and the first of genetic cardiac diseases. The definition of HCM is an increase of the myocardial thickness of the left ventricle (LV) wall without any other causes of hypertrophy. It's characterized by an important heterogeneity of prognosis and clinical expression going from a asymptomatic state until the devastating sudden death occurring in a young person.The diagnosis of HCM is definite by a myocardial thickness greater or equal to 15mm (or 13mm if there is a familial history).This hypertrophy is often accompanied by other abnormalities detected by echocardiography: dynamic left ventricular outflow obstruction at rest or stress, mitral regurgitation …Now, the current challenge is to determine the prognosis factors of the disease that could help to identify the patients with high risk of sudden death. Some prognosis factors are knowed and used in the calculation of a new risk score. This risk score allows to estimate the risk of sudden death at 5 years and propose depending on the result, the implantation of a defibrillator for primary prevention.The physiopathological mechanism of HCM is very complex and still misunderstood. Myocardial fibrosis could be a major mechanism of the disease evolution. Indeed, fibrosis is responsible of scar areas where ventricular tachycardia may develop. Moreover, if the fibrosis is very extensive, it can be the responsible of a systolic or diastolic dysfunction of the left ventricle leading to heart failure.Myocardial ischemia caused by a microvascular dysfunction is now recognized as an important mechanism of the disease evolution. Acute ischemic events could be a trigger of malignant arrhythmia whereas chronic ischemia leads to fibrosis.Left ventricle function is long time preserved in HCM. Segmentary hypokinesia corresponding to extensive fibrosis appears at a very advanced stage of the disease. Exercice stress echocardiography permits to detect myocardial ischemia caused by microvascular dysfunction in the HCM before the fibrosis apparition. Moreover the investigators suggest to study the deformation parameters by speckle tracking or 2D strain witness of a contractile LV dysfunction before the apparition of segmentary hypokinesia.Magnetic resonance imaging (MRI) is now recognized as the more sensible technique to identify focal myocardial fibrosis resulting in areas of late gadolinium enhancement (LGE). LGE is frequent in HCM and his extension is correlated with the severity of the hypertrophy and the risk of sudden death. Myocardial ischemia is detected by hypoperfused defects in the perfusion sequences and as LGE, is correlated with the degree of hypertrophy. Some studies using stress MRI with vasodilatator agent show inductible hypoperfused areas correlated to the degree of hypertrophy. T1 mapping is a new hopeful sequence of MRI permitting to detect the diffuse and early myocardial fibrosis. Some studies show that T1 mapping values are reduced in the areas of LGE in HCM but also in areas without LGE which reflects the presence of new fibrosis.The objective of study is to compare these two imagery techniques in order to detect ischemia and fibrosis. These techniques are usually used in the diagnosis or the monitoring of the disease. The investigators propose to realize an exercise stress echocardiography to study: the segmentary kinetic of the left ventricle and the 2D strain and a stress MRI to study the LGE, the stress perfusion and the T1 mapping.Actually the investigators consider that LGE is a risk factor of the disease (although not yet involved in the calculation of the risk of sudden death) and need to be study in each MRI realized for HCM. From the same way, the investigators suggest to follow patients to determine if the abnormalities detected by these two techniques and particularly 2D strain abnormalities, stress myocardial ischemia and T1 mapping abnormalities are prognosis factors of the disease and appear more precociously than LGE.

location_facility: Hôpital Arnaud de Villeneuve - CHRU de Montpellier


title: Comparative Effects of Variable Pressure Support, Neurally Adjusted Ventilatory Assist (NAVA) and Proportional Assist Ventilation (PAV) on the Variability of the Breathing Pattern and on Patient Ventilator Interaction

summary:
Experimental animal data suggest that increasing breathing pattern variability in mechanical ventilation could be beneficial. Variable ventilation can be induced through the following modes: Neurally Adjust Ventilatory Assist (NAVA), Proportional Assist Ventilation (PAV) and Variable-Pressure Support Ventilation (V-PSV). These modes have not yet been compared to each other. Pilot observations in our department suggest a feasibility in patients.

The objectives of the study are to compare the impact of PSV, NAVA, PAV and V-PSV on the variability of the breathing pattern, patient-ventilator asynchrony, risk of lung overdistension, gas exchange, and repartition of ventilation.

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

location_facility: Service de Pneumologie et Réanimation Médicale, Groupe Hospitalier Pitié Salpêtrière


title: Perinatal Consequences of Endometriosis: Multicenter Prospective Comparative Study

acronym: ENDOBST

summary:
Endometriosis is a benign gynecological disease, characterized by the presence of endometrium-like tissue outside the uterine cavity that affect up to 10-15% of women in reproductive age worldwide, with an extensive impact on women's wellbeing and their reproductive life. Endometriosis lesions are heterogeneous and three phenotypes of the disease are well recognized and are fundamentally different from each other: superficial peritoneal endometriosis (peritoneal implants), ovarian endometrioma (cyst ovarian endometriosis), and deeply infiltrating endometriosis (invasive nodules greater than 5 mm).

The investigators performed a prospective multicenter comparative study to assess the maternal and fetal risks related to endometriosis during pregnancy, regarding disease phenotype, This study will evaluate with sufficient power the risk of prematurity and obstetrical complications associated with endometriosis according to disease phenotype.

This study aims to provide new informations to pregnant women with endometriosis, guide the monitoring of pregnancy, optimize management strategies based on the nature of complications and ultimately to improve the health of women and their unborn child

intervention_type: Biological

appel_a_projets: PHRCI

acronyme: ENDOSBT

titre: Conséquences périnatales de l'endométriose : étude prospective comparative multicentrique

discipline_principale: autre

nom_porteur: MARCELLIN

prenom_porteur: Louis


title: Comparison of Preoperative Haemoglobin Level After Administration of Epoetin Alfa Associated With an Oral Versus Intravenous Iron Supplementation

acronym: Cross Iron

summary: Patients were recruited at the scheduled preoperative visit for hip or knee arthroplasty. If the haemoglobin (Hb) level was below 13 g/dl with no contraindication to iron supplementation the patients were randomized to the oral or intravenous (IV) group. The oral group received 160 mg ferrous glycine sulfate daily during the month prior surgery, associated with 3 epoetin alpha (EPO) injections (40 000 IU subcutaneous on day - 21, day - 14 and day-7). The IV group received ferric carboxymaltose 1000 mg IV in 15 minutes one month before surgery, associated with 3 EPO injections. Primary efficacy endpoint was the change in Hb level from the day of the preoperative visit to the day before surgery (day-1). Secondary endpoints comprised the Hb level on day 3 and 5 after surgery, allogenic transfusion during and after surgery, and the change in iron indices from the day of the preoperative visit to day - 1.

location_facility: Hôpital Lapeyronie - Département Anesthésie Réanimation A


title: Ultrasound-guided Pudendal Nerve Block in Children: A Descriptive Study of Feasibility

summary:
Objective: Description of a new transperineal technique of pudendal nerve block (PNB), under ultrasound-guidance.

Methods : Successive inclusions after parental consent of 60 children undergoing perineal surgery under general anesthesia and pudendal nerve block. Data were collected from induction of anesthesia to second post-operative day (24 hrs. after admission in recovery room). Ease of PNB achievement was the primary objective evaluated. Efficiency in preoperative and postoperative period was also reported.


title: Hypospadias and Exome: Identification of New Genes for Familial Hypospadias

summary:
Hypospadias is the second most common malformation of the male genitalia and consists in a congenital hypoplasia of its ventral face. Hypospadias results from abnormal development of the penis that leaves the urethral meatus proximal to its normal glanular position. Meatus position may be located anywhere along the penile shaft, but more severe forms of hypospadias may have a urethral meatus located at the scrotum or perineum. Glandular and penile anterior represents approximately 70% of all the diagnosed cases.

The frequency of family reached depend on the severity of hypospadias. The number of children which have hypospadias mutation discovered by classical technique is low. Families are often the cause of the discovery of new genes involved in sexual differentiation because they allow comparison of genomes of related persons, and detect more easily mutations.

status: Enrolling by invitation

intervention_type: Genetic


title: Effects of Inspiratory Muscles Strengthening Among Coronary Patients on the Sleep Apnea Obstructive Syndrome (SAOS)

acronym: RICAOS

summary:
Obstructive sleep apnea (OSA) syndrome affects up to 5% of the general population. The prevalence is multiplied by 13 in coronary artery disease (CAD) patients. Many studies have shown that OSA syndrome was the main risk factor for cardiovascular morbidity and mortality (RR = 9.1 [95%, 2.6 to 31.2]).

If the value of treatment with Continuous Positive Airway Pressure (CPAP) in symptomatic CAD patients (daytime sleepiness and/or 2 clinical symptoms with Apnea Hypopnea Index (AHI) ≥ 20) appears to be established, treatment with CPAP in asymptomatic CAD patients (with AHI> 30) may be too demanding. Alternative treatments are rare and results are highly variable. Therefore, it would be interesting to suggest other treatment modalities with moderate coronary and/or minimally symptomatic OSA syndrome.


title: Illiteracy and Vulnerability to Alzheimer's Disease: Evaluation of Amyloid Pathology by PET Imaging

acronym: AVILL

summary: The goal of this study is to improve the diagnosis of Alzheimer's disease (AD) at two different stages (MCI and dementia) in illiterate subjects, using FDG- fluorodeoxyglucose - and florbetapir F 18 -PET imaging. This study will compare amyloid load and cerebral metabolism dysfunction in literate versus illiterate MCI and AD patients.

intervention_type: Radiation


title: Does the Mycophenolate Improve the Ability of Weaning Patients Off the Treatment in Chronic Inflammatory Demyelinating Polyradiculopathy (CIDP)

acronym: MYCOPID

summary: The main objective is to study if the mycophenolate could decrease the proportion of patients who relapse during the IVIG tapering period and after the IVIG withdrawal.


title: Treatment of the Bilateral Severe Uveitis by IVT of Regulator T-cells: Study of Tolerance of Dose

acronym: UVEREG

summary: Uveitis is a leading cause of blindness in the children and young adult's populations. One third of etiology are idiopathic. The reference treatments are corticosteroids and immunosuppressive agents. They have significant side effects, and patient's compliance is often poor. In addition, some uveitis are more resistant. Also, in these situations of deadlock therapeutic, investigators propose a cell therapy by administering regulatory T cells (Tregs) in the vitreous of patients.

status: Suspended

location_facility: Department of ophthalmology Groupe Hospitalier Pitié-Salpêtrière - Charles FOIX


title: Medico-economic Comparative Assessment of Conventional and CAD/CAM Dental Restorations; Impact on Hospital Dentistry Departments

acronym: EVACFAOD

summary:
Dental restorations (crowns, inlays or onlays) can be made conventionally or by CAD/CAM. The current literature is weak and does not separate the medical results of these two techniques. However, the efficiencies enabled by CAD/CAM could, for the price of an initial investment, improve service to the patient by reducing the time required for these restorations, and possibly lower care costs.

The aim of the study is to compare immediate medical results and short-term prosthetic restorations made conventionally or by CAD/CAM in randomized patients, and evaluate economic impacts and organizational aspects.

location_facility: Service d'Odontologie Hôpital Pitié salpêtrière


title: Evaluation of Efficacy and Safety of a Cashew Apple Extract on Weight Management and Associated Metabolic Risk Factors in Overweight/Obese Volunteers: a Randomized, Double-blind, Placebo-controlled, Parallel-group Clinical Trial

summary: The purpose of this study is to assess the efficacy and safety of a cashew apple extract on weight management and associated metabolic risk factors in overweight/obese volunteers, versus placebo, after 12 weeks of treatment.

ReferenceCitation: Janssen I, Katzmarzyk PT, Ross R. Waist circumference and not body mass index explains obesity-related health risk. Am J Clin Nutr. 2004 Mar;79(3):379-84. doi: 10.1093/ajcn/79.3.379.

ReferenceCitation: Ribeiro da Silva LM, Teixeira de Figueiredo EA, Silva Ricardo NM, Pinto Vieira IG, Wilane de Figueiredo R, Brasil IM, Gomes CL. Quantification of bioactive compounds in pulps and by-products of tropical fruits from Brazil. Food Chem. 2014 Jan 15;143:398-404. doi: 10.1016/j.foodchem.2013.08.001. Epub 2013 Aug 9.

ReferenceCitation: Kuczmarski RJ, Flegal KM. Criteria for definition of overweight in transition: background and recommendations for the United States. Am J Clin Nutr. 2000 Nov;72(5):1074-81. doi: 10.1093/ajcn/72.5.1074.

ReferenceCitation: P. Suganya and R. Dharshini. Value added products from cashew apple - an alternate nutritional source. International Journal of current research, Vol. 3, Issue 7, pp. 177-180, July 2011

ReferenceCitation: Prasertsri P, Roengrit T, Kanpetta Y, Tong-Un T, Muchimapura S, Wattanathorn J, Leelayuwat N. Cashew apple juice supplementation enhanced fat utilization during high-intensity exercise in trained and untrained men. J Int Soc Sports Nutr. 2013 Mar 7;10(1):13. doi: 10.1186/1550-2783-10-13.

ReferenceCitation: Vergara CMAC, Honorato TL, Maia GA, Rodrigues S. Prebiotic effect of fermented cashew apple (Anacardium occidentale L) juice. LWT-Food Sci Technol. 2010; 43:141-145.

lead_sponsor: Dialpha

sponsor_collaborators: Dialpha Naturalpha

location_facility: Clinical Nutrition Center Naturalpha (CNCN)

intervention_type: Dietary Supplement


title: Passage à l'Acte en Maison d'arrêt : Recherche d'éléments Contextuels récurrents Prospectifs et rétrospectifs

acronym: CoDiRCE

summary: The prediction of dangerousness remains a delicate subject, relevant in current psychiatry. Scalable psychopathological elements identified in schizophrenia and mood disorders are considered as most at risk for crime committing. The French High Authority of Health (HAS) recommends to identify and prevent risk situations of violence and to develop research at this level. Some authors have worked on criminal career and became interested in risk factors for aberrant driving behaviors but also in environmental or clinical elements accompanying these phases. To our knowledge, no specific study about contextual elements before misconduct and which could lead to aberrant driving behaviors among individuals diagnosed with antisocial personality disorder has been described to date The investigators propose to follow individuals diagnosed with antisocial personality disorder in prison during 6 months in order to list their conduct disorders and contextual elements upstream of these misconducts. The investigators will also study the effect of contextual factors related to judicial steps on the appearance of aberrant driving behaviors.

ReferenceCitation: Haute Autorité de Santé. Dangerosité psychiatrique : étude et évaluation des facteurs de risque de violence hétéro-agressive chez les personnes ayant des troubles schizophréniques ou des troubles de l'humeur. In: Service des bonnes pratiques professionnelles. Saint-Denis La Plaine: Service documentation - information des publics; 2011.

ReferenceCitation: Quinsey VL, Harris GT, Rice ME, Cormier CA. Violent Offenders: Appraising and Managing Risk, Second Edition. American Psychological Association. Washington, DC, US 2006. 462 p.

ReferenceCitation: Moulin V, Favard A-N.

ReferenceCitation: Moulin V, Senon J-L. Évaluation de la dynamique criminelle et des processus qui sous-tendent l'agir infractionnel dans un cadre expertal, 2010.

ReferenceCitation: Litinetskaia M. Dangerosité, délinquance et passage à l'acte : psychopathologie et prédictivité. Annales médico-psychologiques 170. 99-102; 2012.

ReferenceCitation: Côté G. Vers une définition de la psychopathie. Pham TH & Côté. Villeneuve d'Ascq, France: Presse Universitaire du Septentrion; 2000. 240 p.

ReferenceCitation: Balier C. Psychanalyse des comportements violents. Puf. Rouge LF. Paris1988

ReferenceCitation: Gravier B. Violence et psychopathie. Psychiatrie légale et criminologie clinique. Issy-les-Moulineaux : Elsevier Masson, 2013. Les âges de la vie. ISBN : 978-2-294-73163-1; 2013.

ReferenceCitation: Hare RD, Craigen D. Psychopathy and physiological activity in a mixed-motive game situation. Psychophysiology. 1974 Mar;11(2):197-206. doi: 10.1111/j.1469-8986.1974.tb00839.x. No abstract available.

ReferenceCitation: Vanderstukken O. Troubles de l'attention et des fonctions executives chez les psychopathes. Université catholique de Louvain;1998.

ReferenceCitation: Pham TH. [Psychometric evaluation of the Hare Psychopathy Questionnaire in a Belgian prison population]. Encephale. 1998 Sep-Oct;24(5):435-41. French.

ReferenceCitation: Etude de Cote G, Sheilagh H, Toupin J. citée par Pham TH, Cote G. Psychopathie : Théorie et Recherche. Septentrion Presse Universitaire; 2000.

ReferenceCitation: Sreenivasan S, Kirkish P, Eth S, Mintz J, Hwang S, Van Gorp W, Van Vort W. Predictors of recidivistic violence in criminally insane and civilly committed psychiatric inpatients. Int J Law Psychiatry. 1997 Spring;20(2):279-91. doi: 10.1016/s0160-2527(97)00008-3. No abstract available.

ReferenceCitation: Méry B. Diplôme Inter-Universitaire de psychiatrie criminelle et médicolégale. "Organisation du système pénitentiaire " ; Mars 2014.

ReferenceCitation: Hare RD, Neumann CN. The PCL-R Assessment of Psychopathy: Development, Structural Properties, and New Directions. C. Patrick ed. New York: Guilford; 2006.

ReferenceCitation: Cote G, Hodgins S, Toupin J. Psychopathie : Prévalence et spécificité clinique. Psychopathie : théorie et recherche. Paris : Septentrion Presse Universitaire, 2000, p 47-75. ISBN 2-85939-612-8; 2000.

ReferenceCitation: COTE G., HODGINS S., TOUPIN J. Psychopathie : Prévalence et spécificité clinique. Psychopathie : théorie et recherche. Paris : Septentrion Presse Universitaire, 2000, p 47-75. ISBN 2-85939-612-8. 2000.

ReferenceCitation: Salekin RT, Rogers R, Sewell KW. Construct validity of psychopathy in a female offender sample: a multitrait-multimethod evaluation. J Abnorm Psychol. 1997 Nov;106(4):576-85. doi: 10.1037//0021-843x.106.4.576.

ReferenceCitation: Ministère de la Justice, Statistiques trimestrielles de la population prise en charge en milieu fermé [Consulté le 30/01/2015]. Disponible à partir de l'URL : http://www.justice.gouv.fr/art_pix/trimestrielle_MF_janvier_2014.pdf - Tableau 1. 2014.)

ReferenceCitation: Pham TH. L'évaluation de la psychopathie. Psychiatrie légale et criminologie clinique. Les âges de la vie. Issy-les-Moulineaux : Elsevier Masson; 2000

lead_sponsor: Groupe Hospitalier de la Rochelle Ré Aunis


title: Knowing and Remembering: Cognitive and Neural Influences of Familiarity on Recognition Memory in Early Alzheimer's Disease

acronym: EPMR-MA

summary: Unrandomized, unblinded, monocentric comparative Functional Magnetic Resonance Imaging study.

ReferenceCitation: Jonin PY, Duche Q, Bannier E, Corouge I, Ferre JC, Belliard S, Barillot C, Barbeau EJ. Building memories on prior knowledge: behavioral and fMRI evidence of impairment in early Alzheimer's disease. Neurobiol Aging. 2022 Feb;110:1-12. doi: 10.1016/j.neurobiolaging.2021.10.013. Epub 2021 Oct 29.

oa_host_type: repository

evidence: oa repository (via page says license)

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

repository_normalized: bioRxiv

evidence: oa repository (via OAI-PMH title and first author match)

repository_institution: Cold Spring Harbor Laboratory - bioRxiv

repositories: HAL bioRxiv

repositories_concat: HAL;bioRxiv

repositories_institution: Le Centre pour la Communication Scientifique Directe - HAL - Inserm

unpaywall_oa_status: green

lead_sponsor: Rennes University Hospital


title: Development and Implementation of a Computerized Adaptative Testing (CAT) of Self-perceived Quality of Care in Psychiatry

acronym: QDSPsyCAT

summary:
Objectives

to develop and validate a Computerized Adaptative Testing (CAT) of self-perceived quality of care in Psychiatry.
to analyze the implementation of this new measure in clinical practice : qualitative analysis of the relationship patient/professional.

ReferenceCitation: Fernandes S, Fond G, Zendjidjian X, Michel P, Lancon C, Berna F, Schurhoff F, Aouizerate B, Henry C, Etain B, Samalin L, Leboyer M, Misdrahi D, Llorca PM, Coldefy M, Auquier P, Baumstarck K, Boyer L. A conceptual framework to develop a patient-reported experience measure of the quality of mental health care: a qualitative study of the PREMIUM project in France. J Mark Access Health Policy. 2021 Feb 23;9(1):1885789. doi: 10.1080/20016689.2021.1885789.

license: cc-by-nc

license_normalized: cc-by-nc

publisher_dissemination: Informa

ReferenceCitation: Fernandes S, Fond G, Zendjidjian XY, Baumstarck K, Lancon C, Berna F, Schurhoff F, Aouizerate B, Henry C, Etain B, Samalin L, Leboyer M, Llorca PM, Coldefy M, Auquier P, Boyer L; French PREMIUM Group. Measuring the Patient Experience of Mental Health Care: A Systematic and Critical Review of Patient-Reported Experience Measures. Patient Prefer Adherence. 2020 Nov 3;14:2147-2161. doi: 10.2147/PPA.S255264. eCollection 2020.

ReferenceCitation: Fernandes S, Fond G, Zendjidjian X, Michel P, Baumstarck K, Lancon C, Berna F, Schurhoff F, Aouizerate B, Henry C, Etain B, Samalin L, Leboyer M, Llorca PM, Coldefy M, Auquier P, Boyer L. The Patient-Reported Experience Measure for Improving qUality of care in Mental health (PREMIUM) project in France: study protocol for the development and implementation strategy. Patient Prefer Adherence. 2019 Jan 21;13:165-177. doi: 10.2147/PPA.S172100. eCollection 2019.

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Université Paris 1 Panthéon-Sorbonne

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Inrap

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - ParisTech

repositories_institution: Le Centre pour la Communication Scientifique Directe - HAL - INSU

lead_sponsor: Assistance Publique Hopitaux De Marseille

location_facility: Hopital de la conception Assistance Publique Hôpitaux de Marseille

titre: Elaboration et stratégie d'implantation d'un questionnaire adaptatif de la qualité des soins perçue par les patients en psychiatrie


title: Inform and Reduce Pre-surgical Anxiety of the Child and His Parents: Interest of an Explanatory Movie About the Pathway of the Child in Pediatric Surgery.

summary:
The purpose of the study is to measure the interest of a movie explaining the path of the children in surgery, in order to reduce the anxiety of the children and his parents.

This study is interventional, method randomized, controled, open-label, comparing two parallel arms: anesthesist explanations versus anesthesist explanations + a movie explanation.

ipd_sharing: Yes

ipd_sharing_description:
De-identified data used in the published manuscript will be shared in accordance with the applicable informed consent under which the data was collected

Supporting Information:

Time Frame:

12 months after the main publication

Access Criteria:

Data are provided to qualified investigators free of charge. Required documents to request data include a summary of the research plan, request form, and IRB review. Dataset will be shared after careful examination by the study board of investigators.

Identified data used in the published manuscript will be shared in accordance with the applicable informed consent under which the data was collected

Supporting Information:


title: Study of the Angiogenesis Measured by PET/CT With 18F-RGD-K5 in Patients With Lymphoma : a Preliminary Study

acronym: RGDLymphome

summary: The aim of the study is to measure tumoral angiogenesis modifications by RGD-K5 PET/CT before and after 2 cycles of chemotherapy in patients with lymphoma and a large tumoral mass

lead_sponsor: Centre Henri Becquerel


title: Comparative Study of the Hypoxia Measured in FAZA and F-miso TEP/CT Scan in Patients With Non-small Cell Lung Cancer at the Time of Diagnosis : Correlation With Immunohistochemistry

summary: The purpose of the study is to compare the intratumoral biodistribution of FAZA and F-miso in patients with non-small cell lung cancer and correlate the results of PET scans with immunohistochemistry.

ReferenceCitation: Texte E, Gouel P, Thureau S, Lequesne J, Barres B, Edet-Sanson A, Decazes P, Vera P, Hapdey S. Impact of the Bayesian penalized likelihood algorithm (Q.Clear(R)) in comparison with the OSEM reconstruction on low contrast PET hypoxic images. EJNMMI Phys. 2020 May 12;7(1):28. doi: 10.1186/s40658-020-00300-3.


title: Evaluation of Cytidine Deaminase for Patient Suffering of a Myelodysplasic Syndrom or an Acute Myeloid Leukemia and Treated by Azacytidine

summary: Myelodysplastic syndrome (MDS) is a group of medical conditions derived from progressive bone marrow failure that result in ineffective production of blood cells. Depending on the severity, MDS reduces the quality of life to the point of being life-threatening. There is a probability of death at all stages of the disease, due to complications and co-morbidities, with progression to acute myeloid leukemia (AML) being the worst evolution. Azacytidine is a nucleosidic analog with original epigenetic mechanism of action that is widely used for treating a variety of myelodysplasic syndromes. Although generally well tolerated, severe and sometimes life-threatening toxicities were unexpectedly observed in some patients. Genetic polymorphism affecting cytidine deaminase (CDA), the liver enzyme responsible for azacytidine detoxification step, could be responsible for poor clinical outcome due to on the one hand to severe toxicities in deficient patients, and on the other hand on treatment failure in ultrametabolizer patients.This clinical study aims at correlating the values in CDA levels with the risk of drug-related toxicities and to the clinical response to azacytidine treatment.

sponsor_collaborators: Assistance Publique Hopitaux De Marseille

location_facility: Assistance Publique - Hopitaux de Marseille


title: Effect of a Silicone Hydrocoated Double Loop Ureteral Stent on Symptoms and Quality of Life in Patients Undergoing F-URS for Kidney Stone; a Comparative Randomized Multicenter Clinical Study.

summary: This study is a prospective, randomized multicenter study conducted in Europe. It is designed to compare two double loop ureteral stents in terms of the quality of life in patients operated on a kidney stone and requiring the placement of a double loop ureteral stent at the end of the operation.

lead_sponsor: Coloplast A/S

location_facility: Service de Chirurgie Urologique de l'Hôpital Tenon


title: Interest of Propionibacterium Freudenreichii for the Treatment of Mild to Moderate Ulcerative Colitis

acronym: EMMENTAL

summary:
Ulcerative colitis (UC) is an immune mediated chronic inflammatory bowel disease that results at least in part of an abnormal immune response to environmental factors including the intestinal microbiota. Thus, use of probiotics (microorganisms that are believed to provide health benefits when consume) may restore the gastrointestinal microbiota and reduce intestinal inflammation.

Propionibacterium freudenreichii is used for the production of fermented food products (cheese). Some selected strains have strong anti-inflammatory properties. Use of cheese based on a monoxenic culture of anti-inflammatory strain of Propionibacterium freudenreichii may decrease disease activity during ulcerative colitis.

status: Terminated


title: Postoperative Sedation After Cardiac Surgery: Pilot Study

acronym: SEDCAR

summary: This pilot study evaluates the effectiveness of a closed-loop administration of propofol and remifentanil guided by the bispectral index for short-term sedation after cardiac surgery.

ReferenceCitation: Le Guen M, Liu N, Bourgeois E, Chazot T, Sessler DI, Rouby JJ, Fischler M. Automated sedation outperforms manual administration of propofol and remifentanil in critically ill patients with deep sedation: a randomized phase II trial. Intensive Care Med. 2013 Mar;39(3):454-62. doi: 10.1007/s00134-012-2762-2. Epub 2012 Dec 6.

lead_sponsor: Hopital Foch


title: Study on the Diagnostic Qualities of the Positron Emission Tomography Coupled to the Scanner (PET / CT) in the Assessment of Response to Non-Hodgkin's Lymphoma Therapy in Children and Adolescents

acronym: TEP-LYMPHOME

summary:
This is a diagnostic prospective multicenter study. This study will be conducted in 32 centers of the Société Française des Cancers et Leucémies de l'Enfants et de l'Adolescent (SCFE) in patients with non-Hodgkin lymphoma and treated according to recommendations of the SFCE for each type of non-Hodgkin lymphoma. All patients will have a PET / CT associated with conventional imaging time of remission assessment. Histological examination of residual tumor will be conducted whenever practicable in patients with pathologic residual image on conventional imaging and / or PET / CT. A central review of conventional imaging examinations and PET / CT will be performed independently from each other.

Moreover, whenever possible, patients will have a PET / CT at diagnosis and an early PET / CT (between J8 and J28 according to the type of lymphoma and toxicities due to treatment). The results of the early PET / CT should not lead to treatment modifications.

In case of residual tumor at remission assessment, therapeutics changes as recommended therapeutic protocols will be based on histologic findings and not on the results of PET / CT alone.

lead_sponsor: Gustave Roussy, Cancer Campus, Grand Paris

collaborators: Société Française des Cancers et Leucémies de l'Enfant et de l'Adolescent (SFCE)

location_facility: Gustave Roussy Cancer Campus Grand Paris


title: Phase II Trial Evaluating the Efficacy of Laying a Biliary Stent for Producing a Heavy Chemotherapy in Unresectable Pancreatic Adenocarcinomas

acronym: PROPAC

summary:
For many years, the treatment of jaundice due to head pancreatic adenocarcinoma is based on the endoscopic biliary stent. This technique has been shown to be preferable to a surgical shunt.

Recently, adjuvant chemotherapy with FOLFIRINOX regimen (clinical trial) has revolutionized the treatment of metastatic pancreatic adenocarcinoma increasing overall survival in a major way. This design will also be developed in patients with neoadjuvant tumor called "borderline" (the limit of the resectability).

However, several conditions (protocol) are required to consider the implementation of this design : age ≤ 75 years, PS 0 or 1, good hematological parameters and bilirubin ≤ 1.5 times the ULN.

In addition, a randomized study showed that preoperative biliary stent treatment, despite a success rate of 94%, is associated with more complications than surgery fast (related gesture bladder).

It would be interesting to analyze, prospectively, the fate of a series of patients with cancer of the pancreatic head with compression of the lower part of the bile duct, PS 0 or 1 and for which the only limit to FOLFIRINOX design is jaundice or high risk of jaundice.

lead_sponsor: Institut Paoli-Calmettes


title: Phase Ib Dose Finding Study of BKM 120 in Combination With LH-RH Agonists and Bicalutamide in Men With Non Castrate Metastatic Prostate Cancer

acronym: NCMPC-BKM

summary: To determine the maximum-tolerated dose (MTD) of BKM120 when administered orally in combination with daily bicalutamide and LH-RH agonists to men with non castrate metastatic prostate cancer.

sponsor_collaborators:
Institut Paoli-Calmettes
Novartis


title: Daily Glycaemic Variability in Frail or Disabled Older Patients With Diabetes Over 75 Treated With Basal Insulin

acronym: VARQUOGLY

summary:
Basal insulin is widely used in older patients with diabetes. Human insulin Neutral Protamine Hagedorn (NPH) has been proposed as basal insulin in older (75 years or older) frail and dependent patients due to its shorter action. However, no study has analysed the glycaemic profile in elderly subjects according to the basal insulin used, particularly in frail or disabled patients.

The aim of this study is to measure intra-day glycaemic variability according basal insulin (human NPH or long acting analogues) in older (75 and older) frail or disabled patients with diabetes using continuous glucose monitoring system.

primary_purpose: Health Services Research

location_facility: University Hospital of Bordeaux - Xavier Arnozan Hospital


title: Interest in the Use of Dressings With Honey for Wound Healing After Excision of Pilonidal Cyst

acronym: Pilomiel

summary: The management of pilonidal cysts is a skin excision and under deep skin. Scarring requires regular dressings (daily for 15 days and then every 48 hours) until complete healing. This healing is obtained on average in 68 days. Some patients have difficulties in healing with a final healing achieved on average in 95 days. Some teams use honey to promote wound cavitary wounds (wound infection, pressure ulcers, varicose wound). The acceleration of wound healing is due to antibacterial properties and hyperosmolarity to reduce secretions. ) The use of honey in pilonidal cysts is not evaluated and may accelerate healing.

lead_sponsor: Centre Hospitalier Departemental Vendee


title: Comparison of Ventricular Septal Pacing With Optimized Atrioventricular (AV) Delay to no Pacing in Sinus Node Disease (SND) Patients.

acronym: OPTIMIST

summary:
Optimal pacing strategy for patients with SND is still unknown, although several publications in the past years demonstrated a deleterious effect of ventricular pacing. However, pacing has always been apical in these trials, and to which extent this absence of pacing is beneficial for patients with very long PR intervals is still to be found.

The aim of this study is to compare ventricular septal pacing to no pacing in patients with SND.

lead_sponsor: Abbott Medical Devices


acronym: TEMPO

lead_sponsor: Hospices Civils de Lyon

summary:
Timolol is a nonselective β-blocker commonly used in the treatment of glaucoma. Recently it has been used topically for the treatment of superficial hemangiomas. Because of its potential mechanism of action, it is possible that timolol could also be useful for the treatment of epistaxis in Hereditary Hemorrhagic Telangiectasia (HHT). Moreover a case was reported in 2012 showing an improvement of nosebleeds with the use of topical nasal timolol. The aim of the study is to evaluate timolol nasal spray efficacy in HHT.

The main objective of this trial is to evaluate, 3 months after the end of the treatment, the efficacy on the duration of nosebleeds of a 4 weeks timolol intranasal treatment in HHT patients with nosebleeds (>20 min/month). Secondary objectives are to evaluate the tolerance, the efficacy at 6 months after the end of the treatment, and the efficacy on anemia and on clinical parameters (nosebleeds, quality of life and blood transfusions).

This is a prospective double blind phase II study, randomized versus placebo using an allocation ratio of 1:1. A total of 58 patients will be included. The product (solution with timolol at 0.5% or placebo) is self-administered by the patient with a posology of one spray (50 µL) in each nostril twice a day for 28 consecutive days.

location_facility: Hospices Civils de Lyon - Hôpital Femme Mère Enfant / Service de génétique Clinique

title: Efficacy of a Timolol Nasal Spray as a Treatment for Epistaxis in Hereditary Hemorrhagic Telangiectasia (HHT) - Randomized Trial Versus Placebo


title: Pharmacokinetics and Pharmacogenetics-based Adaptive Dosing of 5-fu (5-Fluorouracile) in Head & Neck Cancer Patient Undergoing Docetaxel, Cisplatin, 5-Fluorouracile (=TPF) Therapy

summary: Docetaxel, Cisplatin, 5-Fluorouracile (=TPF) is a mainstay for treating head and neck cancers, but elderly or fragile patients are often precluded because of the risk of severe toxicities associated with this protocol. DPD (Dihydro Pyrimidine Dehydrogenase) deficiency is a pharmacogenetic syndrome responsible for most of the severe/lethal toxicities showing in 5-FU (5-Fluorouracile)-treated patients, and our institute has developed a strategy for the routine determination of Dihydro Pyrimidine Dehydrogenase (DPD) status prior to starting giving the 5-FU so as to roughly adapt drug dosage according to the Dihydro Pyrimidine Dehydrogenase (DPD) status. This project aims at developing a Bayesian strategy to further individualize 5-FU dosing to reach a target exposure of area under curve (AUC). To this end, 100 patients with head and neck cancer and scheduled for a Docetaxel, Cisplatin, 5-Fluorouracile (=TPF) regimen will be included.

location_facility: Assistance Publique Hôpitaux de Marseille


title: Ultrasound-guided Peripheral Vascular Access: What Approaches in Paediatrics?

summary: Landmarks used to make a vascular puncture has long been based on the only knowledge of anatomy. This method assumes that the target vessel is in its expected position, permeable (non-thrombosed), and heavy enough to be catheterized. Any variations from these assumptions is likely to cause failures of puncture and complications. The development of ultrasound allowed to "see" the structures to achieve, whether before a puncture or in live for guiding the procedure. Visualization of vessels and adjacent structures has logically resulted in larger cases to a greater security of catheterization, improving the success rate, and decreasing complications. Several positions of the probe can be used to guide a puncture under ultrasound: the transversal approach in short axis, the long axis longitudinal approach and the oblique view approach.The aim of the study was to compare these three different ultrasound-guided approaches to peripheral vascular access in children. All children weighing less than 30 kg that should benefit from the introduction of an arterial catheter or central venous catheter introduced through a peripheral vein are eligible. Patients will be included after parent's and children's information and consent. The choice of the technique used (transverse, longitudinal or oblique approach) is determined by a randomization table.The puncture procedure is performed according to the usual protocols of the paediatric anesthesia unit of the investigators, under ultrasound guidance in a sterile manner. No time limit is required for the identification and implementation of the catheter. The position of the probe is dictated by the result of randomization and the Seldinger technique is used for the establishment of the catheter. Beyond two unsuccessful attempts, the procedure is considered as a failure. The anesthetist then uses the alternative technique of his choice. All anesthetists participating in this study exercised their main activity in the Montpellier University Hospital pediatric anesthesia unit. The laying of ultrasound-guided peripherally inserted central catheter and arterial catheter is part of the current activity of the unit.

lead_sponsor: University Hospital, Montpellier


title: Does the FASS (Facial Action Summary Score) Scale Allow to Differentiate the Pain of Postoperative Anxiety in Children Under 7 Years?

acronym: FASS

summary: This study aims to evaluate the psychometric validity of FASS (Facial Summary Score Scale) to assess postoperative children pain.


title: Phase II Study Evaluating the Efficacy of Allogeneic Transplant Conditioning With Adaptive Dose Busulfan Intravenous (Busilvex®) in Patients at High Risk of Carrying Blood Diseases

acronym: BX-PK

summary: Determine the efficiency of a myéloablative conditioning associating Fludarabine, Thymoglobuline, and intravenous Busulfan with adapted dose, according to a pharmacokinetics realized in the first day of administration (or J-6 of the conditioning) of the busulfan, in preparation for a allogenic transplant family or not family compatible HLA.

sponsor_collaborators:
Institut Paoli-Calmettes
Agence de La Biomédecine


title: Evaluation of the Efficacy of Transcutaneous Trigeminal Nerve Stimulation for Prevention of Cerebral Vasospasm and Its Consequences After Subarachnoid Haemorrhage Due to Ruptured Aneurysm: a Multicentre, Randomized, Double-blind Study

acronym: TRIVASOSTIM

summary:
Subarachnoid haemorrhage (SAH) secondary to ruptured aneurysm represents 5 to 15% of all cases of stroke. The mortality rate of SAH is 40% and the risk of serious neurological sequelae among survivors is 10 to 20%.The causes of morbidity and mortality are mainly related to the initial damage induced by SAH and delayed cerebral ischaemia (DCI), which is generally secondary to cerebral vasospasm.

Cerebral vasospasm is one of the main factors of poor prognosis after SAH, as it is associated with a 1.5- to 3-fold increase in the mortality rate during the 2 weeks following SAH in these patients.

Despite a significant improvement in the time to management of this disease and the fact that the ruptured aneurysm is very often rapidly excluded by surgical or endovascular intervention, patients who survive the initial SAH remain at risk of severe complications over the following 2 weeks.

Vascular stenosis of an arterial segment, called cerebral vasospasm, is observed in more than 70 to 95% of cases on digital subtraction angiography between the 7th and 14th days after ruptured aneurysm. This angiographic vasospasm can be responsible for cerebral infarction in 52 to 81% of cases.

Despite 50 years of research, no clearly demonstrated effective treatment for vasospasm is currently available.

This is a multicentre, randomized, comparative study, including 364 patients during the acute phase following ruptured aneurysm, in whom management is very often limited to control of complications, after exclusion of the aneurysm.

The objective of this study is to validate the efficacy of transcutaneous trigeminal nerve stimulation for the prevention of vasospasm and limitation of the consequences of delayed cerebral ischaemia after SAH.

This is an innovative project, as it comprises intervention in these patients prior to the development of complications and could limit the development of these complications. The prevention tool, based on external facial nerve stimulation, is a totally innovative, reversible and noninvasive technique. Use of nerve stimulation in this indication has never been previously reported and could radically modify the intensive care management of this disease over the years to come.

lead_sponsor: Poitiers University Hospital


title: Prognosis and Long Term Pubertal Outcome of Girls Previously Diagnosed With a Prenatal Ovarian Cyst

acronym: KYSTOV

summary: Puberty and long-term ovarian function of patients with a ovarian prenatal cyst has not described to date.

status: Recruiting

status_simplified: Ongoing


title: Physical Activity and Energy Intake Control in Obese Adolescents: Effect of Exercise Programs of Various Intensities

summary: Acute exercise of high intensity has been shown to induced nutritional adaptations in obese adolescents. Indeed, several studies have shown that about 30 minutes of intensive exercise (above 70% of the adolescents maximal aerobic capacities) can favor reduced-energy consumption at the following meal with no modification of their appetite feelings. Although it is suggested that chronic physical activity programs can induce energy intake modifications, this has never been clearly studied. The aim of this work is to compare different physical activity programs (low vs. high intensity programs) in terms of energy intake, appetite feelings and appetite-regulating hormones, in obese adolescents.

lead_sponsor: Université Blaise Pascal, Clermont-Ferrand


title: Intra Individual Evaluation of Uremic Toxin Levels in Hemodialysed Patients

acronym: EVITUPH

summary: Chronic kidney disease (CKD) is characterized by a irreversible decrease of kidney functions. It is characterized by accumulation of solutes called uremic toxins. Uremic toxins levels are implicated in cardiovascular complications associated with CKD. Several protein-bound toxins have been implicated in the increased cardiovascular risk such as indoxyl sulfate (IS), p cresol sulfate (pCS) and more recently the indole acetic acid (IAA). All clinical studies are performed with a single measurement at baseline assuming that the toxin levels are stable over time. The variability of uremic toxins level is not known. Furthermore, little is known concerning determinants of serum toxins level.

location_facility: Assistance Publique H^^opitaux de Marseille


title: Weaning of Norepinephrine Guided by the Dynamic Arterial Compliance in Cardiac Surgery Post Operative.

acronym: SNEAD

summary: After cardiac surgery, vasoplegic syndrome is a hemodynamic state characterized by profound hypotension associated with a decrease in systemic vascular resistance. The care of this disease is based on the intravenous administration of a vasopressor, usually norepinephrine. During the recovery phase, weaning of norepinephrine, is an important step in which any lack of preload (blood volume) initial or secondary can be, and increase tissue malperfusion.

ReferenceCitation: Guinot PG, Bernard E, Levrard M, Dupont H, Lorne E. Dynamic arterial elastance predicts mean arterial pressure decrease associated with decreasing norepinephrine dosage in septic shock. Crit Care. 2015 Jan 19;19(1):14. doi: 10.1186/s13054-014-0732-5.

ReferenceCitation: Guinot PG, Abou-Arab O, Guilbart M, Bar S, Zogheib E, Daher M, Besserve P, Nader J, Caus T, Kamel S, Dupont H, Lorne E. Monitoring dynamic arterial elastance as a means of decreasing the duration of norepinephrine treatment in vasoplegic syndrome following cardiac surgery: a prospective, randomized trial. Intensive Care Med. 2017 May;43(5):643-651. doi: 10.1007/s00134-016-4666-z. Epub 2017 Jan 24.

lead_sponsor: Centre Hospitalier Universitaire, Amiens


title: Single-center, Open-label, Randomized, Multiple-dose, Parallel-group Study to Investigate Safety and Effects on Heart Rate, Blood Pressure, and Pharmacokinetic Interactions of ACT-334441 Combined With Calcium-channel Blocker (Diltiazem) or Beta-blocker (Atenolol) Treatment in Healthy Subjects

summary: The aim of the study is to investigate the safety of the concomitant administration of ACT-334441 with cardiovascular drugs.

lead_sponsor: Idorsia Pharmaceuticals Ltd.


acronym: MORPHAPAIN

lead_sponsor: Assistance Publique - Hôpitaux de Paris

summary: The main objective of this study is to evaluate the efficacy of two drugs: paracetamol and ibuprofen in association with morphine, compared with morphine alone on analgesia in children seen in the emergency department for a long-bone fracture and also to study the potential synergic effect of the association paracetamol and ibuprofen.

ReferenceCitation: Clark E, Plint AC, Correll R, Gaboury I, Passi B. A randomized, controlled trial of acetaminophen, ibuprofen, and codeine for acute pain relief in children with musculoskeletal trauma. Pediatrics. 2007 Mar;119(3):460-7. doi: 10.1542/peds.2006-1347. Erratum In: Pediatrics. 2007 Jun;119(6):1271.

ReferenceCitation: Koller DM, Myers AB, Lorenz D, Godambe SA. Effectiveness of oxycodone, ibuprofen, or the combination in the initial management of orthopedic injury-related pain in children. Pediatr Emerg Care. 2007 Sep;23(9):627-33. doi: 10.1097/PEC.0b013e31814a6a39.

ReferenceCitation: Morton NS, O'Brien K. Analgesic efficacy of paracetamol and diclofenac in children receiving PCA morphine. Br J Anaesth. 1999 May;82(5):715-7. doi: 10.1093/bja/82.5.715.

location_facility: Paediatric emergency Armand Trousseau hospital

title: Phase III Clinical Trial Studying Analgesic Efficacy of Morphine Alone or Combined With Paracetamol and/or Ibuprofen for Long-bones Fractures in Children

appel_a_projets: PHRCN

acronyme: Morphapain

titre: Prise en charge de la douleur de l'enfant ayant une fracture d'un os long par morphine seule ou en association avec le paracétamol et/ou l'ibuprofène

discipline_principale: médecine d'urgence

nom_porteur: CHAPPUY

prenom_porteur: Hélène