title: Study of Efficacy of OXN PR, Compared to Oxy PR, for Reduction of Intensity of Opioid-induced Constipation Symptoms in Pts Treated for Cancer or Non-cancer Pain: A Randomised, Double-blind, Controlled, Multicentre Study

summary: The primary objective of this trial is to study the efficacy of oxycodone/naloxone prolonged release tablets (OXN PR), compared to oxycodone prolonged release tablets (Oxy PR), for the reduction of the intensity of opioid-induced constipation symptoms in patients treated for cancer or non-cancer pain.

lead_sponsor: Mundipharma SAS


title: Phase III Study of Hydrocortisone in Patients With Severe H1N1 Related Pneumonia

acronym: CORTIFLU

summary: The H1N1 flu pandemic is one of the major infectious threat of the past half century. it is rapidly progressing worldwide and a substantial number of patients get severe H1N1 related pneumonia that requires mechanical ventilation and admission to the intensive care unit. The acute respiratory distress syndrome is associated with a substantial mortality and morbidity partly as a consequence of uncontrolled lung and systemic inflammation. many physicians are trying to counteract this pro-inflammatory storm by the use of corticosteroids albeit these drugs may cause super infection or metabolic disorders. Thus, there is a need for a randomized double blind, placebo controlled trial to define the benefit to risk ratio of corticosteroids in this patient.

status: Terminated

study_completion_date_type: Actual

study_type: Interventional

design_allocation: Randomized

primary_purpose: Treatment

enrollment_type: Actual

ReferenceType: result

ReferenceCitation: Annane D, Antona M, Lehmann B, Kedzia C, Chevret S; CORTIFLU Investigators; CRICs; AZUREA; REVA/SRLF networks. Designing and conducting a randomized trial for pandemic critical illness: the 2009 H1N1 influenza pandemic. Intensive Care Med. 2012 Jan;38(1):29-39. doi: 10.1007/s00134-011-2409-8. Epub 2011 Nov 26.

lead_sponsor: University of Versailles

sponsor_collaborators:
University of Versailles
Assistance Publique - Hôpitaux de Paris

intervention_type: Drug

lead_sponsor_type: academique

status_simplified: Unknown


title: Recruitment Maneuver Increases Oxygenation After Intubation in Hypoxemic ICU Patients: a Randomized Controlled Study

summary: The purpose of this study is to evaluate the safety and efficacy of a recruitment maneuver immediately after intubation in hypoxemic patients.

status: Completed

enrollment_type: Anticipated

ReferenceType: background

ReferenceCitation: Constantin JM, Futier E, Perbet S, Roszyk L, Lautrette A, Gillart T, Guerin R, Jabaudon M, Souweine B, Bazin JE, Sapin V. Plasma neutrophil gelatinase-associated lipocalin is an early marker of acute kidney injury in adult critically ill patients: a prospective study. J Crit Care. 2010 Mar;25(1):176.e1-6. doi: 10.1016/j.jcrc.2009.05.010. Epub 2009 Sep 24.

ReferenceType: derived

ReferenceCitation: Constantin JM, Futier E, Cherprenet AL, Chanques G, Guerin R, Cayot-Constantin S, Jabaudon M, Perbet S, Chartier C, Jung B, Guelon D, Jaber S, Bazin JE. A recruitment maneuver increases oxygenation after intubation of hypoxemic intensive care unit patients: a randomized controlled study. Crit Care. 2010;14(2):R76. doi: 10.1186/cc8989. Epub 2010 Apr 28.

lead_sponsor: University Hospital, Clermont-Ferrand

intervention_type: Other

status_simplified: Completed


title: Evaluation de la Mesure du Taux de la Procalcitonine Dans Les Liquides Pleuraux

summary: The purpose of this study is to determine pleural level of procalcitonin in differents situations of pleuritis.

study_type: Observational

time_perspective: Prospective

lead_sponsor: Centre Hospitalier Universitaire, Amiens


type: Registry Identifier

title: Efficacy and Tolerance of Cyproterone Acetate Versus Medroxyprogesterone Acetate Versus Venlafaxine LP in the Treatment of Hot Flushes Caused by Leuprorelin 11.25 mg in Patients Treated for a Prostate Adenocarcinoma

summary: The purpose of this study is to compare the efficacy of three drugs (cyproterone acetate, medroxyprogesterone acetate and venlafaxine) in the treatment of hot flushes caused by leuprorelin LP 11.25 milligram (mg) in participants suffering from prostate cancer.

ReferenceCitation: Irani J, Salomon L, Oba R, Bouchard P, Mottet N. Efficacy of venlafaxine, medroxyprogesterone acetate, and cyproterone acetate for the treatment of vasomotor hot flushes in men taking gonadotropin-releasing hormone analogues for prostate cancer: a double-blind, randomised trial. Lancet Oncol. 2010 Feb;11(2):147-54. doi: 10.1016/S1470-2045(09)70338-9. Epub 2009 Dec 4.

lead_sponsor: Takeda

lead_sponsor_type: industriel


title: Caractérisation de Nouveaux Biomarqueurs de l'Arthrite Septique Par Technique SELDI-TOF

acronym: NOUBASST

summary:
Septic arthritis is a frequent, potentially disabling and/or life-threatening disease. To diagnose a septic arthritis is a complex procedure, first because of numerous differential diagnoses (such as crystal arthritis), second because of poor sensitivity of initial gram staining (for example after untimely antibiotic therapy).

This protocol will use SELDI-TOF as a tool to analyse joint fluid of patients with various acute, polymorphonuclear-rich arthritis, as to determine specific and sensitive new biomarkers of a septic origin.

Such biomarkers will allow rapid diagnosis of septic arthritis in the first hours of admission.

lead_sponsor: University Hospital, Grenoble


title: Study of the Reinnervation of Facial Muscles After Lengthening Temporalis Myoplasty

acronym: FacialReinn

summary: The purpose of this study is to determine the physiology of nerve healing and the neurotization of the facial muscles after lengthening temporalis myoplasty.

primary_purpose: Basic Science

ReferenceCitation: Cheney ML, McKenna MJ, Megerian CA, West C, Elahi MM. Trigeminal neo-neurotization of the paralyzed face. Ann Otol Rhinol Laryngol. 1997 Sep;106(9):733-8. doi: 10.1177/000348949710600903.

ReferenceCitation: Fournier HD, Denis F, Papon X, Hentati N, Mercier P. An anatomical study of the motor distribution of the mandibular nerve for a masseteric-facial anastomosis to restore facial function. Surg Radiol Anat. 1997;19(4):241-4. doi: 10.1007/BF01627866.

ReferenceCitation: Godwin Y, Tomat L, Manktelow R. The use of local anesthetic motor block to demonstrate the potential outcome of depressor labii inferioris resection in patients with facial paralysis. Plast Reconstr Surg. 2005 Sep 15;116(4):957-61. doi: 10.1097/01.prs.0000178043.15510.75.

ReferenceCitation: Guerreschi P, Labbe D, Carluer L, Drillet C, Benateau H. [Manktelow's test for the use of botulic toxin]. Ann Chir Plast Esthet. 2008 Feb;53(1):59-62. doi: 10.1016/j.anplas.2007.04.010. Epub 2007 Jun 27. French.

ReferenceCitation: Labbe D, Huault M. Lengthening temporalis myoplasty and lip reanimation. Plast Reconstr Surg. 2000 Apr;105(4):1289-97; discussion 1298.

ReferenceCitation: Lifchez SD, Matloub HS, Gosain AK. Cortical adaptation to restoration of smiling after free muscle transfer innervated by the nerve to the masseter. Plast Reconstr Surg. 2005 May;115(6):1472-9; discussion 1480-2. doi: 10.1097/01.prs.0000160266.81504.71.

ReferenceCitation: Petropoulos AE, Cheney ML. Induction of facial muscle neurotization by temporalis muscle transposition: literature review and animal model evaluation using horseradish peroxidase uptake. J Otolaryngol. 2000 Feb;29(1):40-6.

ReferenceCitation: Schimek F, Fahle M. Techniques of facial nerve block. Br J Ophthalmol. 1995 Feb;79(2):166-73. doi: 10.1136/bjo.79.2.166.

lead_sponsor: University Hospital, Caen


title: Infertility and Endometriosis : a Prospective Cohort Study

acronym: EndoFertil

summary:
Nowadays, one in six couples consults for fertility problems. If the standard examination and tests do not reveal any cause of infertility, the woman may undergo a laparoscopic exploration which reveals endometriosis in more than 50% of cases.

Endometriosis is an inflammatory disease defined as the presence of endometrial tissue out of the uterine cavity. It is frequent (1 in 10 women) and associated with a high economic burden (22 billion dollars in 2002 in the USA) and important decrease in quality of life. Physiopathological mechanisms and risk factors for endometriosis are not well identified.

A woman with endometriosis is 20 times more at risk of infertility. Fecundity rate of a 25-year-old couple is about 15 to 20% in the general population and only 2 to 10% in case of endometriosis.

There are many manifestations of this disease (infertility, pelvic pain) and the anatomo-clinical correlation is not good. The presently used international classification (American Fertility Society revised in 1985, AFSr) does not predict the chance of pregnancy. New scores such as the Endometriosis Fertility Index (EFI) have been proposed to do so, but need to be validated. Treatment for endometriosis-related infertility is not consensual.

A prospective cohort study would give access to clinical data of patients followed in our center, so as to identify clinical factors predicting pregnancy and to help treatment decision for women with endometriosis suffering from infertility.

status: Unknown status

study_completion_date_type: Anticipated

lead_sponsor: University Hospital, Montpellier


title: Assessment of Splanchnic Oxygenation and Circulation in Neonates at Risk for Necrotizing Enterocolitis Using NIRS and Doppler

acronym: NeoNIRS

summary: The main objective is to evaluate the interest of cerebro-splanchnic oxygenation ratio (CSOR) for early diagnosis of necrotizing enterocolitis (NEC) in neonates with rectal bleeding and/or abdominal distension. CSOR will be determined using near infrared spectroscopy (NIRS).

primary_purpose: Diagnostic

intervention_type: Device


title: Effects of Scan Control for Presumed Difficult Epidural Infiltrations: a Monocentric, Prospective, Randomized, Controlled, Simple Blind Trial

acronym: ECHORACHIS

summary:
The aim of this care protocol is to study the effects of scan to help epidural infiltration realization, in presumed difficult patients suffering from sciatica.

These scans are already performed in our Rheumatology Department but our objective is to evaluate objectively its contribution for patients and doctors.

Epidural infiltration in young patients, with an easy anatomical identification, causes generally no technical difficulties, therefore this protocol will only include patients presumed to have a difficult infiltration, that means those aged more than 60, and/or with BMI > 30 and/or suffering from scoliosis.

This study concerns patients who are hospitalized in Rheumatology Department (Hospital of Nantes) for their first epidural infiltration for treatment-resistant lombosciatica.

Patient will be randomized at Day 0, before infiltration. This latter will be performed in accordance to current practice.

Tolerance data (pain and satisfaction) will be collected just after the infiltration and eventual complications will be reported within 48 hours after infiltration.

Following treatment of lombosciatic will be realized through hospitalization, as usual.

Scan is a safe, non invasive, painless and non radiating exam. It is the extension of the musculoskeletal clinical exam and it has already changed our rheumatology practices. The investigators hope at the end of this study, that results would confirm that scan can be a help in practice to perform epidural infiltrations.

lead_sponsor: Nantes University Hospital

intervention_type: Procedure


title: Randomized Comparison Between the STENTYS Self-expanding Coronary Stent and a Balloon-expandable Stent in Acute Myocardial Infarction - APPOSITION II

acronym: APPOSITION ll

summary: Study hypothesis: the Stentys self-expandable Stent results into a better alignment of the struts to the vessel wall than a balloon-expandable stent within a few days after the procedure in acute myocardial infarction patients.

ReferenceCitation: Nakatani S, Onuma Y, Ishibashi Y, Karanasos A, Regar E, Garcia-Garcia HM, Tamburino C, Fajadet J, Vrolix M, Witzenbichler B, Eeckhout E, Spaulding C, Reczuch K, La Manna A, Spaargaren R, Capodanno D, Van Langenhove G, Verheye S, Serruys PW, van Geuns RJ. Incidence and potential mechanism of resolved, persistent and newly acquired malapposition three days after implantation of self-expanding or balloon-expandable stents in a STEMI population: insights from optical coherence tomography in the APPOSITION II study. EuroIntervention. 2015 Dec;11(8):885-94. doi: 10.4244/EIJY15M11_01.

oa_host_type: publisher

evidence: open (via free pdf)

host_type: publisher

license_normalized: no license

version: publishedVersion

repositories_concat: closed

unpaywall_oa_status: bronze

publisher_dissemination: Europa Digital & Publishing

ReferenceCitation: van Geuns RJ, Tamburino C, Fajadet J, Vrolix M, Witzenbichler B, Eeckhout E, Spaulding C, Reczuch K, La Manna A, Spaargaren R, Garcia-Garcia HM, Regar E, Capodanno D, Van Langenhove G, Verheye S. Self-expanding versus balloon-expandable stents in acute myocardial infarction: results from the APPOSITION II study: self-expanding stents in ST-segment elevation myocardial infarction. JACC Cardiovasc Interv. 2012 Dec;5(12):1209-19. doi: 10.1016/j.jcin.2012.08.016.

lead_sponsor: Stentys


title: An Open, Prospective, National, Multicenter, Non Randomised, Study Based on Healthy Volunteers for Establishing Normative Data for IGF1 in the General Population

acronym: VARIETE

summary:
Various assays can be used for IGF-I measurement in French laboratories. Unfortunately, each assay gives a very different result for the same sample. As IGF-I also varies with age, it is necessary to establish a broad population reference values of IGF1 concentration for each of the IGF1 assays used in clinical practice, taking into account individual variation factors such as age, nutritional status and possible treatments.

The objective of this study is to establish normative data based on a large random selection from the general population, including representation from all age groups (around 100 subjects for each decade age range). This will be performed for all the available assay kits. Subjects with medical conditions and medications that may affect the outcome will be excluded. Normative data will include the range (2.5 to 97.5 percentiles) in mass units and results will be reported as mass units but also as SD scores in order to be able, in a given patient, to compare its IGF-I concentration along time, even if using different assays.

primary_purpose: Health Services Research

ReferenceCitation: Sabbah N, Wolf P, Piedvache C, Trabado S, Verdelet T, Cornu C, Souberbielle JC, Chanson P. Reference values for IGF-I serum concentration in an adult population: use of the VARIETE cohort for two new immunoassays. Endocr Connect. 2021 Aug 26;10(9):1027-1034. doi: 10.1530/EC-21-0175.

oa_colors: green gold

oa_host_type: publisher;repository

evidence: oa journal (via doaj)

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

evidence: oa repository (via pmcid lookup)

host_type: repository

repository_normalized: PubMed Central

repositories_concat: PubMed Central

unpaywall_oa_status: gold

publisher_dissemination: Bioscientifica

ReferenceCitation: Loeb E, Becquemont L, Corruble E. Is the decrease in NOx due to a lack of substrate or a NOS inhibition in patients with major depression? : Commentary on Hess et al. 2017. Psychopharmacology (Berl). 2021 Feb;238(2):613-614. doi: 10.1007/s00213-020-05747-x. Epub 2021 Jan 9. No abstract available.

oa_host_type: closed

publisher_dissemination: Springer-Nature

ReferenceCitation: Mariette X, Perrodeau E, Verner C, Struillou X, Picard N, Schaeverbeke T, Constantin A, Ravaud P, Bouchard P. Role of good oral hygiene on clinical evolution of rheumatoid arthritis: a randomized study nested in the ESPOIR cohort. Rheumatology (Oxford). 2020 May 1;59(5):988-996. doi: 10.1093/rheumatology/kez368.

evidence: open (via free article)

publisher_dissemination: Oxford University Press

ReferenceCitation: Mavromati M, Kuhn E, Agostini H, Brailly-Tabard S, Massart C, Piketty ML, Arnoux A, Young J, Souberbielle JC, Chanson P. Classification of Patients With GH Disorders May Vary According to the IGF-I Assay. J Clin Endocrinol Metab. 2017 Aug 1;102(8):2844-2852. doi: 10.1210/jc.2017-00202.

oa_colors: green other

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

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

repository_normalized: HAL

version: submittedVersion

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

repositories_concat: HAL

publisher_dissemination: The Endocrine Society

ReferenceCitation: Chanson P, Arnoux A, Mavromati M, Brailly-Tabard S, Massart C, Young J, Piketty ML, Souberbielle JC; VARIETE Investigators. Reference Values for IGF-I Serum Concentrations: Comparison of Six Immunoassays. J Clin Endocrinol Metab. 2016 Sep;101(9):3450-8. doi: 10.1210/jc.2016-1257. Epub 2016 May 11.

oa_colors: green hybrid

evidence: open (via crossref license)

license: cc-by

license_normalized: cc-by

license: cc-by-nc

license_normalized: cc-by-nc

repository_institution: PubMed Central - Europe PMC

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - IN2P3

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

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Université Savoie Mont Blanc


title: Etude Pilote évaluant l'Effet du Niveau d'Immersion Sur la Fonction Respiratoire Des Patients tétraplégiques bénéficiant de balnéothérapie

acronym: BALNEORESPI

summary: Balneotherapy is a physiotherapy technique which allows patients to work out in a weightless environment and which is often used in patients with spinal cord injury. In normal subjects, water immersion generates a reduction in lung volumes. The effects of water immersion on the respiratory function of spinal cord injury patient (who are liable to present a respiratory failure secondary to paralysis) are not well known. They could be deleterious (by majoring respiratory failure)or beneficial (by mimicking the effect of a corset and improving respiratory function). Therefore, we are planning to study the effect of different water immersion levels on the respiratory function of spinal cord injury patients.

lead_sponsor: Centre d'Investigation Clinique et Technologique 805


type: Other Identifier

title: Central Effects of Botulinum Toxin: Neurophysiological Study in Stroke Patients With Spastic Lower Limb

summary:
Spasticity is a motor disorder characterized by a velocity-dependent increase in tonic stretch reflex with exaggerated tendon jerk (Lance 1980). Patients with brain lesion often display spasticity due to the interruption of the descending pathways that control the spinal reflex networks, which results in hyperexcitability of the monosynaptic reflex triggered by stretch of the muscle spindles. Spasticity in lower limb muscle impairs the gait, especially in strokes that are the main cause of neurological disability. While 80% of the stroke survivors recover the ability to walk, the poor quality of their gait constitutes a serious handicap in daily life (Bensoussan et al. 2004; Bensoussan et al. 2006).

Local injection of Botulinum toxin (BTx) has become a mainstay of the treatment of focal spasticity, particularly in post-stroke patients. BTx weakens the excessive muscle contraction by blocking the release of acethylcholine from motoneuron terminals at the neuromuscular junction and transiently paralyzing the muscle for several months. Besides this peripheral action, BTx is assumed to have also a central effect (Curra et al. 2004; Gracies 2004; Krishnan 2005; Palomar and Mir 2012). In particular, by affecting also the fusimotor synapses on intrafusal muscles fibers (Rosales and Dressler 2010; Trompetto et al. 2008; Trompetto et al. 2006), BTx may reduce the discharge from muscle spindles, which may be indirectly responsible for functional changes in central motor mechanisms at both spinal and supraspinal levels. Animal experiments also suggested that BTx is carried by retrograde axonal transport to motoneuron soma and possibly transynaptically, and can affect the spinal cholinergic synaptic transmission in the spinal cord. Until now, electrophysiological findings are limited and controversial, probably due to the various motor disorders investigated, the physiological mechanisms tested and the different toxin injection protocols used in the few studies available (Frascarelli et al. 2011; Girlanda et al. 1997; Modugno et al. 1998; Naumann and Reiners 1997; Pauri et al. 2000; Priori et al. 1995; Wohlfarth et al. 2001). Hence, the central action of the toxin in spasticity remains uncertain.

lead_sponsor: Assistance Publique Hopitaux De Marseille

location_facility: Assistance Publique Hopitaux de Marseille


title: French Attitude Registry in Case of ICD Lead Replacement

acronym: FRAGILE

summary:
The average survival rate of a defibrillation lead is 91 to 99% at 2 years, 85-95% at 5 years and 60-72% at 8 years. We must also manage alerts for defibrillation probes with a higher complication rate than average. We will therefore be increasingly confronted with faulty sensors or at risk to be replaced.

There are no standardized approach for replacing defibrillation lead. A record made in the United States showed significant differences according to the teams strategy in case of failure of defibrillation lead in particular with regard to the decision to explant or abandon the probe.

The risk of extracting a defibrillation lead are well known with a major complication rate of 1.6 to 1.95%.

Regarding the risk of complications related to the abandonment of a probe we have less data. For some there is no risk to abandon a defibrillation lead. But others reported a complication rate of 5.5% related to pacing discontinued.

Main objective: Collect the attitude of different centers and different operators when replacing a failed defibrillation lead or "at risk." Explantation or abandonment of the sensor replaced.

study_start_date_type: Actual

ReferenceCitation: Goette A, Cantu F, van Erven L, Geelen P, Halimi F, Merino JL, Morgan JM; Scientific Initiative Committee of the European Heart Rhythm Association. Performance and survival of transvenous defibrillation leads: need for a European data registry. Europace. 2009 Jan;11(1):31-4. doi: 10.1093/europace/eun301. Epub 2008 Nov 11.

ReferenceCitation: Wilkoff BL, Love CJ, Byrd CL, Bongiorni MG, Carrillo RG, Crossley GH 3rd, Epstein LM, Friedman RA, Kennergren CE, Mitkowski P, Schaerf RH, Wazni OM; Heart Rhythm Society; American Heart Association. Transvenous lead extraction: Heart Rhythm Society expert consensus on facilities, training, indications, and patient management: this document was endorsed by the American Heart Association (AHA). Heart Rhythm. 2009 Jul;6(7):1085-104. doi: 10.1016/j.hrthm.2009.05.020. Epub 2009 May 22. No abstract available.

ReferenceCitation: Xu W, Moore HJ, Karasik PE, Franz MR, Singh SN, Fletcher RD. Management strategies when implanted cardioverter defibrillator leads fail: survey findings. Pacing Clin Electrophysiol. 2009 Sep;32(9):1130-41. doi: 10.1111/j.1540-8159.2009.02454.x.

ReferenceCitation: Rickard J, Wilkoff BL. Extraction of implantable cardiac electronic devices. Curr Cardiol Rep. 2011 Oct;13(5):407-14. doi: 10.1007/s11886-011-0198-x.

ReferenceCitation: Wilkoff BL, Byrd CL, Love CJ, Hayes DL, Sellers TD, Schaerf R, Parsonnet V, Epstein LM, Sorrentino RA, Reiser C. Pacemaker lead extraction with the laser sheath: results of the pacing lead extraction with the excimer sheath (PLEXES) trial. J Am Coll Cardiol. 1999 May;33(6):1671-6. doi: 10.1016/s0735-1097(99)00074-1.

ReferenceCitation: Glikson M, Suleiman M, Luria DM, Martin ML, Hodge DO, Shen WK, Bradley DJ, Munger TM, Rea RF, Hayes DL, Hammill SC, Friedman PA. Do abandoned leads pose risk to implantable cardioverter-defibrillator patients? Heart Rhythm. 2009 Jan;6(1):65-8. doi: 10.1016/j.hrthm.2008.10.012. Epub 2008 Oct 11.

ReferenceCitation: Suga C, Hayes DL, Hyberger LK, Lloyd MA. Is there an adverse outcome from abandoned pacing leads? J Interv Card Electrophysiol. 2000 Oct;4(3):493-9. doi: 10.1023/a:1009860514724.

lead_sponsor: French Cardiology Society


title: Postoperative Rehabilitation After Cardiac Surgery in Patients at Risk of Respiratory Complications. Effects of a Continuous Bi-laterosternal Infusion of Ropivacaine Through Multihole Catheters.

acronym: BLS-Sterno

summary: Postoperative pain after cardiac surgery is a risk factor for postoperative complications. In cardiac surgery, pain is more intense during the first 48 hours and disturbs the patient's capacity of coughing, deep breathing, and early mobilisation. It may be responsible for respiratory complications such as bronchial or pulmonary infection, and may also delay the patient's rehabilitation and therefore prolong the duration of in-hospital stay. A previous pilot study performed in our department showed a sensible improvement of analgesia at movement and of rehabilitation with a continuous bilaterosternal infusion of local anaesthesia [Eljezi et al.. Reg Anesth Pain Med 2012; 37:166]. Such strategy shall be tested in a subpopulation of patients at risk for respiratory complication.

ReferenceCitation: Eljezi V, Imhoff E, Bourdeaux D, Pereira B, Farhat M, Schoeffler P, Azarnoush K, Duale C. Bilateral sternal infusion of ropivacaine and length of stay in ICU after cardiac surgery with increased respiratory risk: A randomised controlled trial. Eur J Anaesthesiol. 2017 Feb;34(2):56-65. doi: 10.1097/EJA.0000000000000564.

publisher_dissemination: Wolters Kluwer Health


title: Feasibility Study of Ablathermy Focused Ultrasound (USF) of Breast Tumors Before Mastectomy

acronym: USF

summary: The treatment consists of tumor ablation by Ablathermy Focused Ultrasound (USF), guided by MRI, performed under local anesthesia and sedation.

lead_sponsor: Institut Bergonié


title: Role of FCγRIIIA and FCγRIIA Receptor Polymorphisms in Cetuximab Activity Used in Palliative Treatment of Upper Aerodigestive Tract Tumours

acronym: FCRVADS

summary:
Hypothesis:

Cetuximab, an anti-EGFR antibody, is used with radiotherapy in the treatment of locally advanced and inoperable upper aerodigestive tract cancers. Actually, no predictive biomarkers of Cetuximab antitumor activity are known in this setting. It has been shown recently that FCγRIIIA and FCγRIIA receptor polymorphisms played a role in antitumor activity of trastuzumab and cetuximab.

The investigators therefore hypothesized that FCγRIIIA and FCγRIIA receptor polymorphisms may play a predictive role in Cetuximab effectiveness in upper aerodigestive tract cancers with recurrence or metastatic disease that make them inaccessible to loco regional treatment.


acronym: MIM

summary: The Imatinib Mesylate at a dose of 400 mg / day is the standard treatment for patients with CML-CP. Recent studies show that the quality of response rate (complete cytogenetic response and major molecular response rate) is dependent on the residual plasma Imatinib.

sponsor_collaborators:
Institut Bergonié
Novartis

title: Phase III Trial Evaluating the Effectiveness of a Dose Adjustment of IM on the Molecular Response in Patients With LMC in Chronic Phase Treated With IM 400 mg / Day for at Least Two Years, Complete Cytogenetic Response for at Least One Year

type: EudraCT Number

source: euctr


title: Development of a Technique to Identify New Genes by Studying and Cloning the Breakpoints of de Novo Apparently Balanced Chromosomal Translocations in Patients Presenting With Syndromic Psychomotor Retardation

summary: For every child with developmental delay, the investigators do a constitutional karyotype. This karyotype can reveal an apparently balanced chromosomal rearrangement (no visible loss or gain of genetic material), such as a translocation between two or more chromosomes of accidental occurrence (not transmitted by parents). However, an apparently balanced translocation does not explain the phenotype of the child. Among the hypotheses that could explain the child's symptoms, there is the possibility of another chromosomal abnormality at the translocation breakpoints, another defect elsewhere on the chromosomes or gene disruption at or near the breakpoints. Because the resolution of a constitutional karyotype is limited, these microanomalies can go undiagnosed. The goal of this study is to look for a microanomaly on a chromosome using a technology of higher resolution than that of the conventional karyotype. The proposed study uses DNA microarray technology on DNA extracted from blood lymphocytes to perform high-resolution analysis of all chromosomes to search for an unbalanced microrearrangement (such as loss or gain of chromosomal material). If no microrearrangement is found, the investigators will pursue by looking for a gene disruption defect at or near the breakpoints involved in the translocation. This will be done by first isolating the chromosomes involved in the translocation by flow cytometry and then hybridizing each of the isolated chromosomes on a new microarray. The purpose of this study is to find a possible cause to explain the phenotype (microrearrangement or gene disruption).

ReferenceCitation: Gribble SM, Prigmore E, Burford DC, Porter KM, Ng BL, Douglas EJ, Fiegler H, Carr P, Kalaitzopoulos D, Clegg S, Sandstrom R, Temple IK, Youings SA, Thomas NS, Dennis NR, Jacobs PA, Crolla JA, Carter NP. The complex nature of constitutional de novo apparently balanced translocations in patients presenting with abnormal phenotypes. J Med Genet. 2005 Jan;42(1):8-16. doi: 10.1136/jmg.2004.024141.

location_facility: Laboratory of Chromosomal Genetics - Universitary Hospital

intervention_type: Biological


title: Observational Study of Oxygen Delivery During a Fractional Fluid Expansion

acronym: OR

summary: Fluid expansion during cardiocirculatory insufficiency was helped by cardiac output monitoring. However, the goal of fluid expansion was to increase the oxygen delivery, which consider cardiac output, but also Haemoglobin which decrease during a fluid challenge. The maximalization of cardiac output could decrease the oxygen delivery if the haemodilution was too wide. The aim of this study was to describe the oxygen delivery during a fluid expansion conducted for cardiac output maximalization, following actual guidelines.

time_perspective: Retrospective


title: Effect of a 3 Months Physical Activity Program on the Hormonal Regulation of Food Intake by Intense Physical Activity in Overweight Adolescents

acronym: APHRO

summary:
The primary purpose of this protocol is to assess the hormonal regulation of satiety by an intense exercise before and after a 3 month physical activity program. Hormones assessed are: leptin, grhélin, Cholecystokinin, Glucagon-Like-Peptid-1 (GLP-1), PYY.

It is well known that in overweight adults and children also, an intense physical exercise diminish the food intake relatively to the total energy expenditure and this effect is persistent after a 6 weeks physical activity program.

Our hypothesis are: a diminution of food intake after the intense physical exercise and a persistent diminution of food intake after the 3 month physical activity program, an augmentation of levels of GLP-1 and PYY during the intense exercise before and after the physical activity program, a diminution of the level of GLP-1 and leptin before and after the physical activity program

status: Suspended

intervention_type: Behavioral


summary: In the prospective monocentric open label trial patients with diabetic macular edema will be treated with intravitreal injections of ranibizumab given for 3 months then with laser grid at month 4. During follow-up a ranibizumab injection will be performed every 2 months in case of best-corrected visual acuity decreased more than 5 letters.

lead_sponsor: Poitiers University Hospital


title: Effect of Rotigotine Patch Treatment on Cardiovascular Markers in Idiopathic Restless Legs Syndrome : a Pilot Randomized, Placebo-controlled Study

summary:
Several studies report association between restless legs syndrome (RLS), HTA and cardiovascular diseases .

The mechanisms involved in this relationship remained unknown, but several evidences favor the role of periodic limb movements in sleep (PLMS), patterns frequently associated with RLS. Sympathetic overactivity is associated with PLMS with increased pulse rate and blood pressure coincident with PLMS. PLMS-related repetitive nocturnal blood pressure fluctuations could contribute to the risk of high blood pressure, heart disease, and stroke in patients with RLS, especially in the elderly. Several studies already reported that dopaminergic agonists reduce the severity of RLS and the PLMS index.

Do dopaminergic agonists reduce the risk of cardiovascular diseases and associated autonomic dysfunctions in patients with RLS ?

Nocturnal BP (blood pressure) decline has major clinical implications, and the loss of normal reduction in BP during sleep is associated with high risk of cardiovascular morbidity and mortality.

The main aim of this study was to evaluate the impact of rotigotine patch treatment on validated cardiovascular risk factors ambulatory BP during night, day and night-to-day ratio, and endothelial function in patients with idiopathic RLS compared to placebo.


acronym: HEPAVALV

summary: To assess if the non use of heparin sodium during balloon aortic valvuloplasty reduces serious complications due to the procedure, by decreasing the rate of vascular and hemorrhagic complications without increasing the rate of ischeamic events.

title: Balloon Aortic Valvuloplasty Performed Without Heparin to Decrease Vascular and Bleeding Complications of the Procedure


title: Influence of the Vitamin D Blood Levels on the Amyotrophic Lateral Sclerosis Phenotype

summary: The main objective of this study is to investigate the correlation between the rate of motor decline and blood levels of Vitamin D total. Secondary objectives are to investigate the relationship between blood levels of vitamin D and total disease duration of ALS, forced vital capacity, weight loss, age of onset and the start site of ALS.


title: Follow-up of Patients' Physical Activity in Post-hospitalization by Implementation of Systems of Active Monitoring.

acronym: TICAA'DOM

summary: Physical exercise has been identified as a major item of many affecting many chronic diseases and stroke rehabilitation. It contributes to an improvement in the quality of life and to a decrease in the current treatment side-effects and mortality. Stroke in association with an inactive lifestyle lead to a decrease in physical capability and causes problems in daily activities. The physical capacity and the tolerance for exercise fall simultaneously leading to vicious circle of less and less mobility. Therefore, physical activity for the health is a valid and relevant way to improve the quality of life and to recover functional capacity. The aim of the study is the assessment of the effects of a incentive program for physical activity on people following/with stroke.

primary_purpose: Other

ReferenceCitation: Guediri A, Chaparro D, Borel B, Daviet JC, Compagnat M, Mandigout S. The effect of a home-based coaching program on heart rate variability in subacute stroke patients: a randomized controlled trial. Int J Rehabil Res. 2022 Sep 1;45(3):201-208. doi: 10.1097/MRR.0000000000000529. Epub 2022 May 2.

ReferenceCitation: Mandigout S, Chaparro D, Borel B, Kammoun B, Salle JY, Compagnat M, Daviet JC. Effect of individualized coaching at home on walking capacity in subacute stroke patients: A randomized controlled trial (Ticaa'dom). Ann Phys Rehabil Med. 2021 Jul;64(4):101453. doi: 10.1016/j.rehab.2020.11.001. Epub 2020 Nov 28.

license: publisher-specific-oa

license_normalized: publisher-specific

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

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Université Paris Descartes

unpaywall_oa_status: hybrid

publisher_dissemination: Elsevier

ReferenceCitation: Chaparro D, Daviet JC, Borel B, Kammoun B, Salle JY, Tchalla A, Mandigout S. Home-based physical activity incentive and education program in subacute phase of stroke recovery (Ticaa'dom): study protocol for a randomized controlled trial. Trials. 2018 Jan 25;19(1):68. doi: 10.1186/s13063-017-2410-9.

repositories:
HAL
PubMed Central

repositories_concat: HAL;PubMed Central

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

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

lead_sponsor: University Hospital, Limoges


title: A Single Blind Cross Over Trial to Compare Osteopathic Compression of Pterygopalatine Node to Sham in Patients With Obstructive Sleep Apnea Syndrome and in Healthy Subjects

acronym: OSTEOSAOSII

summary: The main objective is to evaluate an osteopathic compression of pterygopalatine node in healthy subjects and patients suffering from obstructive apnea syndrome (OSA).

lead_sponsor: Assistance Publique - Hôpitaux de Paris

location_facility: Service des pathologies du sommeil, Pitié-Salpêtrière hospital


title: Amplifying Graft-versus-tumor Effect by Donor Regulatory T-cell Depletion Before Donor Lymphocytes Infusion: a Phase I/II Clinical Study

acronym: ILD-Treg

summary: The investigators have previously shown that depletion of CD4+CD25+FoxP3+ regulatory T cells (Treg) enhances the alloreactivity of T lymphocytes, as attested by an accelerated GVHD after allogeneic hematopoietic stem cell transplantation (HSCT) in mice. The investigators thus propose a clinical trial to test whether Treg-depleted donor lymphocytes infusion (dDLI) could induce an improved graft-versus-tumor (GVT) effect in patients refractory to standard DLI (stdDLI) for treatment of relapse after HSCT.

design_allocation: Non-Randomized

ReferenceCitation: Maury S, Lemoine FM, Hicheri Y, Rosenzwajg M, Badoual C, Cherai M, Beaumont JL, Azar N, Dhedin N, Sirvent A, Buzyn A, Rubio MT, Vigouroux S, Montagne O, Bories D, Roudot-Thoraval F, Vernant JP, Cordonnier C, Klatzmann D, Cohen JL. CD4+CD25+ regulatory T cell depletion improves the graft-versus-tumor effect of donor lymphocytes after allogeneic hematopoietic stem cell transplantation. Sci Transl Med. 2010 Jul 21;2(41):41ra52. doi: 10.1126/scitranslmed.3001302.

sponsor_collaborators:
Assistance Publique - Hôpitaux de Paris
Université Paris XII
Pierre and Marie Curie University

appel_a_projets: PHRCN

region: Île-de-France

nom_etablissement: ASSISTANCE PUBLIQUE-HOPITAUX DE PARIS

type_etablissement: CHUR

acronyme: AA Treg

titre: Amplifier les lymphocytes T régulateurs pour le traitement de l'aplasie médullaire acquise: une approche combinant l'interleukine2 à faible dose suivie de l'infusion de lymphocytes T régulateurs autologues amplifiés ex vivo.

discipline_principale: hématologie / vigilance et thérapeutique transfusionnelles

nom_porteur: MAURY

prenom_porteur: Sébastien


title: Safety and Efficacy of Carboxymethylcellulose for Ocular Surface Integrity in Symptomatic Dry Eye

summary: This study will evaluate the safety and efficacy of OPTIVE® MD for ocular surface integrity in symptomatic dry eye condition in absence of obvious eye-lid inflammation.

lead_sponsor: Allergan


title: Accuracy of Pleth Variability Index (PVI) in Predicting Response to Intravenous Fluid Load During Scoliosis Surgery in Children

acronym: PVI

summary:
Plethysmographic Variability index is a simple index accurate in predicting fluid responsiveness.

The aim of this study was to investigate its accuracy in predicting fluid response to intravenous fluid challenge during scoliosis surgery in children.

ReferenceCitation: Feldman JM, Sussman E, Singh D, Friedman BJ. Is the pleth variability index a surrogate for pulse pressure variation in a pediatric population undergoing spine fusion? Paediatr Anaesth. 2012 Mar;22(3):250-5. doi: 10.1111/j.1460-9592.2011.03745.x. Epub 2011 Dec 6.

location_facility: Department of Anesthesiology, Robert Debre University Hospital


title: Replace Sandostatine® in Three Daily Subcutaneous Injections by a Single Intramuscular Injection of Sandostatine® LP Per Month in Patients With a Diffuse Form of Hyperinsulinism

summary: To replace Sandostatine® in three daily subcutaneous injections by a single intramuscular injection of Sandostatine® LP per month in patients with a diffuse form of hyperinsulinism.

sponsor_collaborators:
Assistance Publique - Hôpitaux de Paris
Novartis


title: Comparison of Two Tapering Strategies of Prednisone in Patients With Generalised Myasthenia Gravis Treated With Prednisone and Azathioprine: a Single-blind Randomised Controlled Multicenter Study

acronym: MYACOR

summary:
Pathology - Generalized myasthenia gravis (MG) is cause of muscle weakness that can have a significant impact on daily life activity but can also be, when respiratory or bulbar muscles are involved, life-threatening.

Rationale - Additionally to thymectomy, which indication of is still debated in absence of thymoma, the long-term treatment of generalized myasthenia gravis includes usually prednisone and azathioprine. However, the most used scheme for prescribing and tapering corticosteroid in MG resulted in a very important cumulative dose of prednisone. Indeed, at twelve month, more than 50 percent of patients are still daily treated with at least 18 mg of prednisone and the proportion of patients who are in remission and no longer taking prednisone is very low (Palace and NEWSOM Davis, Neurology 1998). Prolonged corticosteroid therapy is accompanied with various and major side effects, hypertension, osteoporosis, weight gain, glaucoma. Therefore, tapering, eventually discontinuing, prednisone earlier is a relevant therapeutic goal.

For this reason, the investigators will compare to the standard one, a strategy consisting of a rapid decrease in corticosteroid.

Objective - To assess whether, in patients with generalized MG requiring a long-term treatment with corticosteroids and azathioprine, that the strategy of rapid tapering allows discontinuing more rapidly the prednisone for equivalent efficacy than the classical strategy.

ReferenceCitation: Sharshar T, Porcher R, Demeret S, Tranchant C, Gueguen A, Eymard B, Nadaj-Pakleza A, Spinazzi M, Grimaldi L, Birnbaum S, Friedman D, Clair B; MYACOR Study Group. Comparison of Corticosteroid Tapering Regimens in Myasthenia Gravis: A Randomized Clinical Trial. JAMA Neurol. 2021 Apr 1;78(4):426-433. doi: 10.1001/jamaneurol.2020.5407.

publisher_dissemination: American Medical Association


title: Validation of the Sentinel Node in Endometrial Cancer

acronym: Senti-Endo

summary: The purpose of this study is to investigate the relevance of sentinel node in endometrial cancer. Sentinel node is thought to reflect the status of lymph node. Only 10 to 20% of women with endometrial cancer exhibit lymph node metastasis hence systematic lymphadenectomy is questionable. In breast cancer, melanoma and vulvar cancer, sentinel node has emerged as an alternative to complete lymphadenectomy.

ReferenceCitation: Darai E, Dubernard G, Bats AS, Heitz D, Mathevet P, Marret H, Querleu D, Golfier F, Leblanc E, Rouzier R, Ballester M. Sentinel node biopsy for the management of early stage endometrial cancer: long-term results of the SENTI-ENDO study. Gynecol Oncol. 2015 Jan;136(1):54-9. doi: 10.1016/j.ygyno.2014.09.011. Epub 2014 Oct 22.

ReferenceCitation: Ballester M, Dubernard G, Lecuru F, Heitz D, Mathevet P, Marret H, Querleu D, Golfier F, Leblanc E, Rouzier R, Darai E. Detection rate and diagnostic accuracy of sentinel-node biopsy in early stage endometrial cancer: a prospective multicentre study (SENTI-ENDO). Lancet Oncol. 2011 May;12(5):469-76. doi: 10.1016/S1470-2045(11)70070-5. Epub 2011 Apr 12.


title: Trial of Autonomic neuroModulation for trEatment of Chronic Heart Failure

acronym: TAME-HF

summary: The purpose of this clinical investigation is to evaluate the safety and efficacy of Spinal Cord Stimulation (SCS) in advanced heart failure (HF) patients with Implantable Cardioverter Defibrillator (ICD) but not indicated for Cardiac Resynchronization Therapy (CRT).

status: Withdrawn

lead_sponsor: Abbott Medical Devices


title: Evaluation of the Impact of Care Based on Sensory Support for Elderly Patients Suffering From Alzheimer'S-type Neurodegenerative Disease

acronym: SensiCare

summary: The main objective of this study is to evaluate the effect of 3 months of "Snoezelen-type" multi-sensory care sessions on NeuroPsychiatric Inventory Questionnaire (NPI-Q) scores for patients with Alzheimer's-type neurodegenerative disease.

primary_purpose: Supportive Care

lead_sponsor: Centre Hospitalier Universitaire de Nīmes

location_facility: CHU de Nîmes - Centre de Gérontologie de Serre Cavalier


title: Etude Phase I/II d'immunothérapie Par protéine recWT1-A10+AS01B après Greffe allogénique de Cellules Souches

summary:
Patients with acute or chronic myeloid leukemia, or myelodysplastic syndrome, underwent allogeneic stem cell transplantation from HLA-identical donor (related or unrelated) after reduced-intensity conditioning regimen.

If WT1 expression is detectable on tumor cells, they will receive an immune therapy 60 days after allograft.

6 administrations every 2 weeks of the protein recwt1-A10+AS01B will be administrated.

The safety and immunological efficacy of this immune therapy after hematopoietic stem cells transplantation with reduced intensity conditioning will be evaluated.

lead_sponsor: Institut Paoli-Calmettes


title: Optimizing Communication During Nasal Mechanical Ventilation

acronym: PHONOVNI

summary: Mechanical ventilation is one of the only treatment that has improved survival of patients with neuromuscular respiratory failure. As disease progresses, some patients may require longer ventilation period. Non invasive mechanical ventilation is the preferred method of ventilation but it may interfere with speech and communication of patients who require ventilation throughout the day. The investigators are evaluating the effect on speech and communication of a ventilation device which allows patients to momentarily and voluntarily withhold ventilation if they want to speak. This should allow the patients to have a more fluid speech.

sponsor_collaborators: Centre d'Investigation Clinique et Technologique 805


title: Evaluation of the Diagnostic Value of Portable Ultrasound for Dyspneic Patient Support in the Emergency Department: a Randomized Study

acronym: VSCAN-DYSP

summary: The main objective of our study is to compare the effects of two care strategies for dyspneic patients on the length of hospital stay: (1) standard care (=contextual analysis + conventional clinical chest radiography) versus (2) standard care + pleuropulmonary ultrasound.

primary_purpose: Prevention

sponsor_collaborators: Centre Hospitalier Universitaire de Nīmes

location_facility: CHU de Nîmes - Hôpital Universitaire Carémeau


title: Effects of Abnormal Respiratory Mechanics and Assisted Mechanical Ventilation on Neuro Regulation of Respiration

acronym: RegAIN

summary:
Due to recent technological improvements, it is now possible to record the electrical activity of the diaphragm (Eadi), a direct expression of the central nervous system respiratory center activity. By providing a relatively easy-to-use technique to record Eadi the NAVA (Neurally Adjusted Ventilatory Assist) technology offers a new opportunity to explore the effects of various interventions on neural inspiratory activity in human subjects during spontaneous and assisted ventilation both for normal and simulated abnormal respiratory mechanics.

The main aim of this project is to measure and compare the components of Eadi signal, the direct reflect of the respiratory centers activity, under various conditions of normal and simulated altered respiratory mechanics (either obstructive or restrictive respiratory mechanics° in order to better understand the neuroregulation of breathing. The second aim of the present project is to perform a similar analysis regarding the effects of various modes (Pressure Support and NAVA) and various levels of assisted ventilation both in case of normal and abnormal respiratory mechanics. Based on the information recorded on Eadi and flow and pressure signals, the last aim of this project is to correlate Eadi and pneumatic derived parameters both during spontaneous breathing and assisted ventilation.

Practically, by using the NAVA recording technology, the investigators will perform a physiological study on normal volunteers to explore the effects of normal and simulated abnormal respiratory mechanics on Eadi, flow and pressure signals (airway, oesophageal and transdiaphragmatic pressures) in order to better understand the neuroregulation of breathing. Thirty healthy volunteers with documented normal lung function tests will be included in the study (obstructive respiratory mechanics will be simulated in 15 healthy volunteers and respiratory mechanics will be simulated in 15 healthy volunteers).

ReferenceCitation: Piquilloud L, Beloncle F, Richard JM, Mancebo J, Mercat A, Brochard L. Information conveyed by electrical diaphragmatic activity during unstressed, stressed and assisted spontaneous breathing: a physiological study. Ann Intensive Care. 2019 Aug 14;9(1):89. doi: 10.1186/s13613-019-0564-1.

repository_institution: Université de Lausanne - SERVAL

repository_institution: University of Toronto - TSpace

repository_normalized: localhost

repositories:
PubMed Central
localhost
serval.unil.ch

repositories_concat: PubMed Central;localhost;serval.unil.ch

repositories_institution:
PubMed Central - Europe PMC
University of Toronto - TSpace
Université de Lausanne - SERVAL

lead_sponsor: University Hospital, Angers

location_facility: Medical Intensive Care Unit, University Hospital of Angers


title: Bacteriophages Effects on Pseudomonas Aeruginosa Presents in Sputum of Cystic Fibrosis (CF) Patients

acronym: MUCOPHAGES

summary: Pulmonary phage therapy to treat bacterial infections of the respiratory tract have been investigated in animals. The aim of the present study is to evaluate the efficacy of bacteriophages in infecting Pseudomonas aeruginosa (PA) strains present in sputum samples. A cocktail of 10 bacteriophages will be applied on 60 sputum samples obtained from cystic fibrosis (CF) patients during 6 hours.We will determine the bacteria and bacteriophages strains in sputum samples collected. Then the sensitivity of individual colony will be tested.

location_facility: CHU de Montpellier - Hôpital Arnaud de Villeneuve CRCM


title: Effect of URELL(Cranberry Vaccinium Macrocarpon)Consumption on the Prevalence of Recurrent Urinary Tract Infection and Asymptomatic Bacteriuria During Pregnancy.

summary: Evaluation of the effect of URELL consumption on the occurrence of recurrent urinary tract infection (Acute cystitis, pyelonephritis and asymptomatic bacteriuria).

lead_sponsor: Hopital Foch


title: A French Non Interventional Multicentric Cohort Study in Patients With Colorectal Dysplasia in Intestinal Inflammatory Diseases

summary:
The main purpose is to describe clinical practices nowadays prospectively about patients with a dysplasia diagnosis or another histological lesions.

It will be identified colic situation during the initial colonoscopy after dysplasia diagnosis or atypical lesion.

Also the frequency and the type of monitoring conducted about these patients(surgical and endoscopic treatments).

The main criterion evaluation will be the surgical and endoscopic rates during the time.

The treatments offered such as surgical, endoscopic ones or none of them will be followed.

Finally, the outcome of these patients: stability, lesion disappearance, surgery or development of cancer with frequencies for each of them and relationships with histological abnormal colorectal lesion will be measured.

status: Active, not recruiting

lead_sponsor: Hôpital Edouard Herriot

status_simplified: Ongoing


title: Comparison of Difficult Intubation Rates Using McGrath Mac Video Laryngoscope vs Standard Macintosh Laryngoscope in Critically Ill Patients - a Prospective Interventional Study

summary: Difficult intubation is associated with a worse outcome in intensive care unit (ICU). New videolaryngoscope devices are proposed to improve airway management in ICU patients. We aimed to compare a new videolaryngoscope called " McGrath Mac Video Laryngoscope" vs standard Macintosh Laryngoscope in critically ill patients on difficult intubation and/or Cormack 3-4 rates in a prospective interventional study.The present study was conducted to test the hypothesis that the implementation of a quality-improvement process for airway management using a new videolaryngoscope would be associated with a decreased incidence of difficult intubation and/or Cormack 3-4.

lead_sponsor: University Hospital, Montpellier

location_facility: Centre Hospitalier Universitaire Montpellier, Saint Eloi


title: Randomized, Double-blind, Placebo-controlled Study of the Tolerability, and Pharmacokinetics of Fexinidazole After Single and Repeated Oral Ascending Doses, Completed by a Comparative Bioavailability Study of an Oral Suspension Versus a Tablet and an Exploratory Assessment of Food Effect, in Healthy Male Volunteers

summary: This study is aimed at assessing the tolerability and pharmacokinetic parameters of the fexinidazole in healthy volunteers. In animal models of both acute and chronic experimental Trypanosomiasis infections, fexinidazole shows highly promising efficacy.

lead_sponsor: Drugs for Neglected Diseases

sponsor_collaborators:
Drugs for Neglected Diseases
Sanofi


title: Prospective Study of the Influence of Periodontal Diseases on Pre-term Birth: Observation in the Maternity Hospital of Nantes

summary: The aim of the study is to determine the influence of the periodontal diseases in patients giving pre-term birth in the maternity hospital of Nantes. A French population is observed. The clinical, bacteriological and microbiological aspects will confirmed a comparative study which aim is dental prevention in the beginning of the pregnancy to avoid premature delivery.

lead_sponsor: Nantes University Hospital


title: Effect of the Injection of Local Analgesia With Epinephrine During Total Hip Arthroplasty on the Blood Losses Per and Operatively.

summary: The aim is to determine if the use of infiltration with an adrenalin solution in the operative field of Total Hip Arthroplasty (THA), allays a significant reduction of the cumulated volume of bleeding (pre and post operative) without increasing the per and post operative risks. At the same time, the effect on the post operational pains is evaluated.

lead_sponsor: University Hospital, Clermont-Ferrand

location_facility: CHU Clermont-Ferrand (orthopaedic surgery)


title: Speech Effects of a Speaking Valve Versus External PEEP in Tracheostomized Ventilator-Dependent Neuromuscular Patients

summary:
Background:

Many patients with respiratory failure related to neuromuscular disease receive chronic invasive ventilation through a tracheostomy. Improving quality of life, of which speech is an important component, is a major goal in these patients. The investigators compared the effects on breathing and speech of low-level positive end-expiratory pressure (PEEP, 5 cm H2O) and of a Passy-Muir speaking valve (PMV) during assist-control ventilation.

Methods:

Flow will be measured using a pneumotachograph. Microphone speech recordings were subjected to both quantitative measurements and qualitative assessments; these last consisted of a perceptual score and an intelligibility score determined by two speech therapists using a French adaptation of the Frenchay Dysarthria Assessment.

lead_sponsor: University of Versailles

location_facility: Intensive care Ward of R. Poincaré Hospital


title: A Monocenter, Cross-sectional Study to Compare Different Type of Cognitive Impairment in Multiple Sclerosis Patients and Cerebrospinal Fluid Biomarkers (Beta Amyloid, Total Tau Protein and Tau-phosphorylated Protein).

acronym: BioCogS

summary: In multiple sclerosis (MS) sub cortical cognitive impairments are frequently reported. Nevertheless, cortical cognitive troubles, with hippocampic memory troubles have been described. Besides inflammatory damage, early cortical and degenerative damage are well known. In neurodegenerative diseases, three biomarkers of the cerebro spinal fluid (CSF), reflecting lesional mechanisms, are measured: the beta amyloid peptide, the tau total protein, and the phospho tau protein. Preliminary studies shown increased level of tau in MS. No study compare cognitive impairment and biomarkers of CSF.The aim of this study is to measure in the CSF of MS patients these three biomarkers (beta amyloid peptide, tau total and phosphotau) in order to establish correlations between a profile of biomarkers and a pattern of cognitive troubles, cortical or subcortical.The possibility to show, in MS patients with memory hippocampic troubles, a profile of biomarkers closed from the one encountered in AD, could argue in support of the degenerative hypothesis in MS and lead to discuss the interest of the use of AD treatment in MS.


acronym: AIRPEDIA

summary:
The aim of the study is to assess the cost-effectiveness of telemedicine in the care of chronic diabetic foot ulcers.

Patients will be randomized into 2 groups: 1/conventional care group with iterative visits to diabetes specialist or 2/innovative care (telemedicine group).

the health insurance system perspective is adopted.

ReferenceCitation: Hazenberg CE, Bus SA, Kottink AI, Bouwmans CA, Schonbach-Spraul AM, van Baal SG. Telemedical home-monitoring of diabetic foot disease using photographic foot imaging--a feasibility study. J Telemed Telecare. 2012 Jan;18(1):32-6. doi: 10.1258/jtt.2011.110504. Epub 2011 Nov 8.

ReferenceCitation: Foltynski P, Ladyzynski P, Migalska-Musial K, Sabalinska S, Ciechanowska A, Wojcicki J. A new imaging and data transmitting device for telemonitoring of diabetic foot syndrome patients. Diabetes Technol Ther. 2011 Aug;13(8):861-7. doi: 10.1089/dia.2011.0004. Epub 2011 May 13.

ReferenceCitation: Bowling FL, King L, Paterson JA, Hu J, Lipsky BA, Matthews DR, Boulton AJ. Remote assessment of diabetic foot ulcers using a novel wound imaging system. Wound Repair Regen. 2011 Jan-Feb;19(1):25-30. doi: 10.1111/j.1524-475X.2010.00645.x. Epub 2010 Dec 6.

ReferenceCitation: Larsen SB, Clemensen J, Ejskjaer N. A feasibility study of UMTS mobile phones for supporting nurses doing home visits to patients with diabetic foot ulcers. J Telemed Telecare. 2006;12(7):358-62. doi: 10.1258/135763306778682323.

ReferenceCitation: Wilbright WA, Birke JA, Patout CA, Varnado M, Horswell R. The use of telemedicine in the management of diabetes-related foot ulceration: a pilot study. Adv Skin Wound Care. 2004 Jun;17(5 Pt 1):232-8. doi: 10.1097/00129334-200406000-00012.

ReferenceCitation: Muller M, David-Tchouda S, Margier J, Oreglia M, Benhamou PY. Comment on Rasmussen et al. A Randomized Controlled Trial Comparing Telemedical and Standard Outpatient Monitoring of Diabetic Foot Ulcers. Diabetes Care 2015;38:1723-1729. Diabetes Care. 2016 Jan;39(1):e9-10. doi: 10.2337/dc15-1659. No abstract available.

publisher_dissemination: American Diabetes Association

lead_sponsor: University Hospital, Grenoble


title: Evaluation of the Safety and Efficacy of WST11-mediated Vascular Targeted Photodynamic Therapy on Obstructing Endobronchial Non-Small Cell Lung Cancer

summary: The aim of this study is to determine the dose of WST11 and light energy necessary to obtain desobstruction of the bronchial lumen using Vascular Targeted Photodynamic therapy in obstructive Non-Small Cell Lung Cancer.

lead_sponsor: Steba Biotech S.A.


title: Impact of Functional Insulinotherapy on Blood Glucose Variability Indicators in Patients With Type 1 Diabetes

acronym: VARIAFIT

summary:
The primary objective of this trial is to assess whether functional insulinotherapy decreases blood glucose variability at 3 months and 6 months, compared to initial values in type 1 diabetes patients.

So, this study measures the impact of functional insulinotherapy on several blood glucose variability indicators in patients with type 1 diabetes.

This trial also has a secondary objective: to measure the effect of functional insulinotherapy on oxidative stress and inflammation.

ReferenceCitation: Benhamou PY, Somers F, Lablanche S, Debaty I, Borel AL, Nasse L, Stanke-Labesque F, Faure P, Boizel R, Halimi S. Impact of flexible insulin therapy on blood glucose variability, oxidative stress and inflammation in type 1 diabetic patients: the VARIAFIT study. Diabetes Metab. 2014 Sep;40(4):278-83. doi: 10.1016/j.diabet.2014.01.004. Epub 2014 Feb 24.

lead_sponsor: Association Grenobloise pour le Developpement D'etudes et de Recherches en Physiopathologie Endocrinienne, Diabetologie et Maladies de la Nutrition

location_facility: Service de Diabétologie du Pr Halimi, CHU


title: A Prospective, Multicenter, Randomized Trial Comparing Laparoscopy VS Conventional Mesh Repair of Incisional and Umbilical Hernia

acronym: EVENTRALAP

summary: The aim of this study is to compare immediate and long-term (24 months) results of laparoscopic and open mesh repair of incisional and umbilical hernia.

ReferenceCitation: Slim K, Vons C. [Inguinal hernia repair: results of randomized clinical trials and meta-analyses]. J Chir (Paris). 2008 Mar-Apr;145(2):122-5. doi: 10.1016/s0021-7697(08)73720-7. French.

ReferenceCitation: Vons C. [Laparoscopic treatment of ventral hernias]. J Chir (Paris). 2004 Nov;141(6):366-70. doi: 10.1016/s0021-7697(04)95361-6. No abstract available. French.

ReferenceCitation: Proske JM, Vons C. [Laparoscopic treatment of ventral hernias]. J Chir (Paris). 2004 Nov;141(6):360-4. doi: 10.1016/s0021-7697(04)95360-4. French.

location_facility: Hôpital Jean Verdier, department of digestive and general surgery


title: Randomized Phase III Study of Gemcitabine/Cisplatine (GC) Versus High-dose Intensity Methotrexate, Vinblastine, Doxorubicine and Cisplatin (HD-MVAC) in the Perioperative Setting for Patients With Locally Advanced Transitional Cell Cancer of the Bladder

acronym: VESPER

summary: Radical cystectomy remains the gold standard treatment for invasive non metastatic transitional cell cancer (TCC) of the bladder. In contemporary series, specific survival rates are about 60 to 65% at 5 years, decreasing for locally advanced disease to 45-50% in patients with nonorgan-confined lymph-node negative tumours and to 30-35% in patients with lymph node positive tumours. Perioperative chemotherapy (adjuvant ou neoadjuvant) has been developed in order to improve these results. Thanks to randomized trials and meta-analysis, it can be concluded that perioperative chemotherapy increases overall survival with an absolute benefit of 5%, equating to a survival rate of 50% at 5 years for nonorgan-confined tumours. However, the chemotherapy administration time and the optimal chemotherapy regimen to be delivered are not yet determined. Meta-analyses have shown that the benefit is only observed for chemotherapy regimens including cisplatin. In daily management 4 to 6 cycles of gemcitabine and cisplatin are delivered since this combination has been shown to yield a similar efficacy with a better tolerance as compared to the MVAC regimen (methotrexate, vinblastine, doxorubicin and cisplatin) in the metastatic setting. As HD-MVAC has been shown to be associated with higher response rates than MVAC in bladder metastatic disease, also a better efficacy of HD-MVAC can be suspected in the perioperative setting. Investigators therefore designed a randomized phase III study to compare the efficacy of GC and HD-MVAC in term of progression-free survival in patients for whom chemotherapy has been decided, before or after radical cystectomy. Secondary endpoints include overall survival, side effects, response rate in the neoadjuvant setting and ancillary studies focusing on gemcitabine and cisplatin sensitivity. The total number of patients projected is 500. The number of patients is based on the median progression-free survival rate of 50% at 3 years observed in patients treated with GC (standard arm A) in the perioperative setting. An absolute improvement of 10% (HR=0.74) is expected with HD-MVAC (experimental arm B) with a=0.05 and b=0.20. An interim analysis is planned after the occurrence of 174 events. With an estimated uniform accrual rate of 140 patients per year for 3.5 years and exponential survival, the final analysis is expected to occur 8 years after the start of the trial.

ReferenceCitation: Pfister C, Gravis G, Flechon A, Chevreau C, Mahammedi H, Laguerre B, Guillot A, Joly F, Soulie M, Allory Y, Harter V, Culine S; VESPER Trial Investigators. Dose-Dense Methotrexate, Vinblastine, Doxorubicin, and Cisplatin or Gemcitabine and Cisplatin as Perioperative Chemotherapy for Patients With Nonmetastatic Muscle-Invasive Bladder Cancer: Results of the GETUG-AFU V05 VESPER Trial. J Clin Oncol. 2022 Jun 20;40(18):2013-2022. doi: 10.1200/JCO.21.02051. Epub 2022 Mar 7.

publisher_dissemination: American Society of Clinical Oncology (ASCO)

lead_sponsor: University Hospital, Rouen


acronym: LANDSCAPE

lead_sponsor: UNICANCER

summary:
RATIONALE: Lapatinib ditosylate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. Drugs used in chemotherapy, such as capecitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving lapatinib ditosylate together with capecitabine may kill more tumor cells.

PURPOSE: This phase II trial is studying how well giving lapatinib ditosylate together with capecitabine works in treating patients with stage IV breast cancer and brain metastases.

ReferenceCitation: Pierga JY, Bidard FC, Cropet C, Tresca P, Dalenc F, Romieu G, Campone M, Mahier Ait-Oukhatar C, Le Rhun E, Goncalves A, Leheurteur M, Domont J, Gutierrez M, Cure H, Ferrero JM, Labbe-Devilliers C, Bachelot T. Circulating tumor cells and brain metastasis outcome in patients with HER2-positive breast cancer: the LANDSCAPE trial. Ann Oncol. 2013 Dec;24(12):2999-3004. doi: 10.1093/annonc/mdt348. Epub 2013 Sep 6.

ReferenceCitation: Bachelot T, Romieu G, Campone M, Dieras V, Cropet C, Dalenc F, Jimenez M, Le Rhun E, Pierga JY, Goncalves A, Leheurteur M, Domont J, Gutierrez M, Cure H, Ferrero JM, Labbe-Devilliers C. Lapatinib plus capecitabine in patients with previously untreated brain metastases from HER2-positive metastatic breast cancer (LANDSCAPE): a single-group phase 2 study. Lancet Oncol. 2013 Jan;14(1):64-71. doi: 10.1016/S1470-2045(12)70432-1. Epub 2012 Nov 2.

title: A Multicenter Phase II Clinical Trial Assessing the Efficacy of the Combination of Lapatinib and Capecitabine in Patients With Non Pretreated Brain Metastasis From HER2 Positive Breast Cancer


title: Front-line High-dose Chemotherapy (HDT) Combined With Rituximab for Adults With Aggressive Large B-cell Lymphoma (DLBCL) : Goelams 074 Trial.

summary: A prospective pilot trial was proposed to patients with DLBCL, with IH or high adjusted IPI, up to the age of 60 y.o. This program consisted of 2 courses of high-dose R-CHOP-like regimen, followed by a course of high-dose methotrexate with cytarabin. For patients who achieved at least a PR, ASCT started with a BEAM regimen.

sponsor_collaborators:
Nantes University Hospital
French Innovative Leukemia Organisation
Hoffmann-La Roche


title: Co-analgesic Effects of Dexamethasone and Pregabalin After Lumbar Slipped Disc Surgery

acronym: DEXA-PG-HD

summary:
The aim of the study is to show a decrease in postoperative pain during the first postoperative mobilization surgery lumbar disc herniation through a co-analgesia with a single dose of dexamethasone, pregabalin, or a combination of these two products.

Pain assessed by simple numerical scale will be also evaluated during the 48 first post-operative hours.

Determining an optimal co-analgesic protocol through the results of this study could help develop validation studies with larger scale such as a medico-economic component. In addition, these study protocols are easy to apply (ponctual administration) and inexpensive.

ReferenceCitation: Momon A, Verdier B, Dolomie JO, Gardette M, Pereira B, Curt I, Duale C. A Single Preoperative Administration of Dexamethasone, Low-dose Pregabalin, or a Combination of the 2, in Spinal Surgery, Does Not Provide a Better Analgesia Than a Multimodal Analgesic Protocol Alone. Clin J Pain. 2019 Jul;35(7):594-601. doi: 10.1097/AJP.0000000000000719.


title: Multicenter Randomized Study for Medico-economic Evaluation of Embolization With Flow Diverter Stent in the Endovascular Treatment of Unruptured Saccular Wide-necked Intracranial Aneurysms

acronym: EVIDENCE

summary: Unruptured saccular intracranial aneurysms larger than 7 mm can be treated with endovascular occlusion using detachable coils, with or without expendable stent assistance. A new endovascular technique has recently been developed, using flow diverter stents without associated coils. Clinical results already published are encouraging but have to be confirmed. Furthermore, these medical devices are expensive in comparison to the coiling strategy. The purpose of this study is to compare the clinical efficacy, safety, and cost-effectiveness of endovascular coiling and endovascular flow diversion for unrupted saccular intracranial aneurysms.

lead_sponsor: Hospices Civils de Lyon


title: Study of Microcirculatory Effects of Bevacizumab in Patients Treated for Metastatic Colon Cancer or Glioblastoma

acronym: BEVACAPI

summary:
The treatment of the most common cancers (colon, breast, lung, liver and kidney) has recently added a new therapeutic class known as the "anti-angiogenic". It was born from a better understanding of tumor growth requires the development of neo-vessels. These new vessels are of major importance for the viability of the tumor but also the birth of metastases. This neo-angiogenesis is complex and results from an imbalance between pro-angiogenic factors and anti-angiogenic factors. Growth factor VEGF and its receptors (VEGFR-1, VEGFR-2 and VEGFR-3) are a way of survival of endothelial cells required for tumor neoangiogenesis. The anti-angiogenic drugs currently available on the market are bevacizumab (Avastin ®), sunitinib (Sutent ®) and sorafenib (Nexavar ®). The mechanism of anti-angiogenic action of these three main drugs are pharmacological inhibition of the VEGF pathway.

These new anti-angiogenic therapies, however, have significant adverse effects are common and some other more serious but rare.

Hypertension is the most common side effect observed in patients treated with anti-VEGF. This is usually iatrogenic hypertension controlled by antihypertensive therapy and rarely compromises the pursuit of anti-angiogenic therapy. More rarely, it can have serious consequences malignant hypertension, severe hypertension refractory reversible posterior leukoencephalopathy associated with severe hypertension have also been reported.

The pathophysiology of hypertension may be due to the neutralization of major physiological effects of VEGF in endothelial cell and therefore the vascular wall.

The study of the microcirculation is not only useful in the diagnosis of microvascular but also macrovascular disease in the evaluation of chronic arterial and venous severe it determines the prognosis. In these indications, capillaroscopy remains the gold standard for all work pathophysiological because visualization of phenomena measured avoids artifacts and difficulties of interpretation. It then appealed to additional technology to directly measure the capillary pressure, capillary flow velocity, and indirectly assess capillary permeability and function of lymphatic canaliculi. The simplest of these technological inputs: video microscopy and digital image analysis, have also improved the practice of routine clinical capillaroscopy in its main field of application, evaluation of microangiopathy connective. The examination can be performed more quickly and easily archived and quantified.

Only two studies on 14 and 16 patients were able to see a decrease in capillary density correlated with the therapeutic activity of anti-angiogenic the tumor mass and metastasis.

Thus, we propose to quantify in a number of relatively large patient patients the decrease in capillary density as well as the relationship between the decrease in the number of capillaries and anti-tumor response.

The study will also aim to measure the prevalence of hypertension in patients treated with bevacizumab and to establish the link between these data and the modification of the capillary microcirculation.

ReferenceCitation: Fumet JD, Bertaut A, Bengrine L, Lapierre P, Vincent J, Ghiringhelli F, Falvo N. Capillary density has no value as an early biomarker of bevacizumab efficacy in metastatic colorectal cancers: a prospective clinical trial. Oncotarget. 2017 Dec 1;9(16):12599-12608. doi: 10.18632/oncotarget.22822. eCollection 2018 Feb 27.

evidence: open (via page says license)

evidence: oa repository (semantic scholar lookup)

repositories_concat: PubMed Central;pdfs.semanticscholar.org

publisher_dissemination: Impact Journals, LLC

lead_sponsor: Centre Georges Francois Leclerc


title: Characterization of the Digestive Functions and the Enteric Nervous System in Obesity. Investigations of Relationships With Metabolism Disorders(EnteroNeurObesity)

summary: 60 patients scheduled for bariatric surgery will be included into 3 categories (20 patients with non complicated obesity, 20 patients with metabolic syndrome and 20 patients with a type 2 diabetes or hypertension). 20 volunteers will be enrolled as normal referents. The patients and the volunteers will have a classical pre-operative check-up (fibroscopy, oesophageal pHmetry and manometry) and extra investigations as isotopic gastric empty exam, lactulose oro-caecal transit exam, intestinal permeability test calculated by lactulose-manitol ratio urinary excretion. Intestinal and colonic biopsies will be also provided for studying permeability. For only patients, samples from the gastric resection will be provided for analysing the enteric nervous system and motricity.


title: Comparison of Two Strategies of Oropharyngeal and Tracheal Suctioning in Mechanically Ventilated Patients: a Pilot Trial

acronym: AMYLASPI

summary: The purpose of this study is to evaluate the impact of an optimized suctioning procedure on the risk of endotracheal microaspiration, measured by tracheal to oropharyngeal ratio of amylase enzymatic activity.

ipd_sharing: No

lead_sponsor: University Hospital, Bordeaux

sponsor_collaborators:
University Hospital, Bordeaux
Teleflex


title: Comparison of the Efficacy of Subthalamic Nucleus, Caudate Nucleus and Nucleus Accumbens Electric Stimulation in Severe and Resistant Obsessive-compulsive Disorder.

summary:
Deep brain stimulation (DBS) has been proposed for severe and resistant obsessive-compulsive disorder. This electrical stimulation has been tested on, and shown to be effective at, different targets (subthalamic nucleus, caudate nucleus & nucleus accumbens). However, the efficacies of each target have never been compared directly.

This protocol aims to do so, with the hypothesis that subthalamic (STN) stimulation will be more efficacious.

lead_sponsor: Assistance Publique - Hôpitaux de Paris

location_facility: Centre d'investigation Clinique Pitié Salpêtrière


title: Bendamustine in Patients With Refractory or Relapsed T-cell Lymphoma. A Phase II Multicenter Study "BENTLY"

acronym: BENTLY

summary: A Phase II clinical study to determine the efficacy of single agent Bendamustine for T cell lymphoma "BENTLY".

ReferenceCitation: Damaj G, Gressin R, Bouabdallah K, Cartron G, Choufi B, Gyan E, Banos A, Jaccard A, Park S, Tournilhac O, Schiano-de Collela JM, Voillat L, Joly B, Le Gouill S, Saad A, Cony-Makhoul P, Vilque JP, Sanhes L, Schmidt-Tanguy A, Bubenheim M, Houot R, Diouf M, Marolleau JP, Bene MC, Martin A, Lamy T. Results from a prospective, open-label, phase II trial of bendamustine in refractory or relapsed T-cell lymphomas: the BENTLY trial. J Clin Oncol. 2013 Jan 1;31(1):104-10. doi: 10.1200/JCO.2012.43.7285. Epub 2012 Oct 29.

lead_sponsor: French Innovative Leukemia Organisation

sponsor_collaborators:
French Innovative Leukemia Organisation
Mundipharma Pte Ltd.


title: Evaluation of the Short Effects of a Rehabilitation Session on Gait Parameters in Patients With a Lesion of the Central Nervous System

summary:
The aim of the study is to evaluate the short effects of a two rehabilitation session commonly performed in physical therapy,

muscle strengthening of the lower limbs and
effort reconditioning with cyclo ergometer, on gait characteristics (kinematics, kinetics and electromyographic) in patients with central nervous system lesion.

lead_sponsor: Centre d'Investigation Clinique et Technologique 805


acronym: IDEA

lead_sponsor: GERCOR - Multidisciplinary Oncology Cooperative Group

summary:
RATIONALE: Drugs used in chemotherapy, such as oxaliplatin, leucovorin calcium, and fluorouracil, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. It is not yet known whether giving more than one drug (combination chemotherapy) is more effective when given for 3 months or 6 months in treating patients with colon cancer.

PURPOSE: This randomized phase III trial is studying giving combination chemotherapy for 3 months to see how well it works compared with giving combination chemotherapy for 6 months in treating patients with stage III colon cancer.

ReferenceCitation: Andre T, Vernerey D, Mineur L, Bennouna J, Desrame J, Faroux R, Fratte S, Hug de Larauze M, Paget-Bailly S, Chibaudel B, Bez J, Dauba J, Louvet C, Lepere C, Dupuis O, Becouarn Y, Mabro M, Egreteau J, Bouche O, Deplanque G, Ychou M, Galais MP, Ghiringhelli F, Dourthe LM, Bachet JB, Khalil A, Bonnetain F, de Gramont A, Taieb J; for PRODIGE investigators, GERCOR, Federation Francaise de Cancerologie Digestive, and UNICANCER. Three Versus 6 Months of Oxaliplatin-Based Adjuvant Chemotherapy for Patients With Stage III Colon Cancer: Disease-Free Survival Results From a Randomized, Open-Label, International Duration Evaluation of Adjuvant (IDEA) France, Phase III Trial. J Clin Oncol. 2018 May 20;36(15):1469-1477. doi: 10.1200/JCO.2017.76.0355. Epub 2018 Apr 5.

ReferenceCitation: Gallois C, Shi Q, Meyers JP, Iveson T, Alberts SR, de Gramont A, Sobrero AF, Haller DG, Oki E, Shields AF, Goldberg RM, Kerr R, Lonardi S, Yothers G, Kelly C, Boukovinas I, Labianca R, Sinicrope FA, Souglakos I, Yoshino T, Meyerhardt JA, Andre T, Papamichael D, Taieb J. Prognostic Impact of Early Treatment and Oxaliplatin Discontinuation in Patients With Stage III Colon Cancer: An ACCENT/IDEA Pooled Analysis of 11 Adjuvant Trials. J Clin Oncol. 2023 Feb 1;41(4):803-815. doi: 10.1200/JCO.21.02726. Epub 2022 Oct 28.

ReferenceCitation: Delattre JF, Cohen R, Henriques J, Falcoz A, Emile JF, Fratte S, Chibaudel B, Dauba J, Dupuis O, Becouarn Y, Bibeau F, Taieb J, Louvet C, Vernerey D, Andre T, Svrcek M. Prognostic Value of Tumor Deposits for Disease-Free Survival in Patients With Stage III Colon Cancer: A Post Hoc Analysis of the IDEA France Phase III Trial (PRODIGE-GERCOR). J Clin Oncol. 2020 May 20;38(15):1702-1710. doi: 10.1200/JCO.19.01960. Epub 2020 Mar 13.

location_facility: GERCOR Groupe Cooperateur Multidisciplinaire en Oncologie

title: A Phase III Randomized Trial Investigating the Duration of Adjuvant Therapy(3 Versus 6 Months) With the Modified FOLFOX 6 or XELOX Regimens for Patients With Stage III Colon Cancer


title: Evaluation Des Anomalies Muqueuses Intestinales Par vidéocapsule Endoscopique au Cours de la sclérodermie systémique : Etude Prospective, Multicentrique et Inter-régionale

acronym: sclero-video

summary: The aim of this prospective study is to determine prevalence and characteristics of small intestinal mucosal abnormalities in 40 patients with systemic sclerosis, using capsule endoscopy. The investigators' findings may improve management of small intestinal involvement in patients with systemic sclerosis.


title: A Phase 1 Study Evaluating the Phototoxic Potential of LEO 29102 Cream (2.5 mg/g, 1.0 mg/g, 0.3 mg/g, 0.1 mg/g, 0.03 mg/g) and the Cream Vehicle, Applied on Intact Skin of Healthy Male Subjects

summary: The purpose of this trial is to evaluate the phototoxic potential of a single application on healthy skin of LEO 29102 cream in different doses.

lead_sponsor: LEO Pharma


title: Angiotensin II Receptor Blockers, Steroids and Radiotherapy in Glioblastoma- A Randomized Multicenter Trial

acronym: ASTER

summary: To assess the efficacy of an Angiotensin-II inhibitor (Losartan) to reduce peritumoral edema in newly diagnosed glioblastoma patients.

ReferenceCitation: Ursu R, Thomas L, Psimaras D, Chinot O, Le Rhun E, Ricard D, Charissoux M, Cuzzubbo S, Sejalon F, Quillien V, Hoang-Xuan K, Ducray F, Portal JJ, Tibi A, Mandonnet E, Levy-Piedbois C, Vicaut E, Carpentier AF. Angiotensin II receptor blockers, steroids and radiotherapy in glioblastoma-a randomised multicentre trial (ASTER trial). An ANOCEF study. Eur J Cancer. 2019 Mar;109:129-136. doi: 10.1016/j.ejca.2018.12.025. Epub 2019 Feb 1.

evidence: open (via crossref license, author manuscript)

version: acceptedVersion

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Aix-Marseille Université

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

collaborators: ANOCEF (french association of neuro-oncologists)

location_facility: Neurology Department - Avicenne Hospital


title: RAS Blockade at Bedtime Versus on Awakening for the Prevention of Aldosterone Breakthrough

summary:
Objective:

To show that the frequency of aldosterone breakthrough is lower when RAS blockers are given at bedtime compared to on awaking, and to analyze the determinants and consequences of aldosterone breakthrough.

Duration of the study: Inclusion 2 years, follow-up one year, total 3 years Design: prospective, multicenter, randomized, controlled, open label, two parallel groups.

Main selection criteria:

Inclusion criteria

Chronic kidney disease stage 3 to 4,
ACEI (captopril, enalapril, or ramipril), and/or ARB (losartan, valsartan, or irbesartan) on awaking for at least three months,
History of hypertension or proteinuria > 0,5 g/24h or g/g créatininurie.

Exclusion criteria

Office blood pressure ≥ 160/100 mmHg,
Anti-aldosterone (spironolactone, eplerenone) or potassium sparing diuretics (modamide, amiloride), or direct renin inhibitor.

Evaluation criteria:

Primary: Serum aldosterone levels at one year.

Secondary:

Serum aldosterone/renin ratio,
24h urine aldosterone,
Significant aldosterone breakthrough defined by a >10% increase of serum aldosterone levels over baseline values,
Aldosterone breakthrough defined by an increase of serum aldosterone levels over baseline values,
HbA1c,
Urinary albumin/creatinine ratio (UACR) on spot morning urine samples,
Systolic home blood pressure (SBP),
Estimated glomerular filtration rate (eGFR) using the MDRD equation.

lead_sponsor: Centre Hospitalier Universitaire de Nice

location_facility: Department of Nephrology, Nice University Hospital


title: Study of the Association Between Digital Osteoarthritis and Lower Limb Osteoarthritis (Knee and Hip) in Terms of Severity and Evolution - Khoala Group Ancillary Project / Cohort Khoala

acronym: Khoala

summary: Among the risk factors for lower limb osteoarthritis, if obesity is probably the most studied, digital osteoarthritis received increasing interest in recent years. Recent publications have highlighted a link between obesity and digital osteoarthritis, but also a very probable link between digital osteoarthritis and structural progression of knee osteoarthritis. Few data including hip exist and need to be confirmed on larger scale studies. We have with "Khoala" a national multiregional cohort of symptomatic gonarthrosis and coxarthrosis representative of the general population (which is rarely the case in the literature) including X ray, clinical and biological follow-up (hips and / or knees).

sponsor_collaborators: Centre Hospitalier Universitaire de Nice

location_facility: Department of rheumatology, nice university hospital

intervention_type: Radiation


acronym: SCIALERO

summary:
Ropivacaine 0.5% and 0.5% in levobupivacaïne are used in regional anesthesia for major surgery of the foot. The literature does not highlight a significant difference in terms of onset of action between these two molecules to block the sciatic nerve [4]. Our hypothesis is that this lack of difference is due to the use of a neurostimulator for locating the injection site (indiscriminate nature of the anatomical approach to the sciatic nerve). Indeed, the sensitivity of neurostimulation is low compared with ultrasound [58] and ultrasound, for accurate visualization of the deposit of the local anesthetic around the nerve to improve the quality of the block and reduce the onset of action of local anesthetic [46, 47].

The investigators propose to make a comparative trial between levobupivacaïne 0.5% ropivacaine and 0.5% under the control of the ultrasound as part of a sciatic nerve block. The use of ultrasound will reduce the variability of results because the changes would be linked exclusively to the local anesthetic. The investigators test the hypothesis that levobupivacaïne gives better results in terms of onset of action than ropivacaine.

lead_sponsor: Nantes University Hospital


title: Intra-individual Efficacy Evaluation of DOTAREM®-Enhanced MRA Compared to GADOVIST®-Enhanced MRA in the Diagnosis of Clinically Significant Abdominal or Lower Limb Arterial Diseases

summary: This study is an intra-individual comparison of DOTAREM®-enhanced MRA and GADOVIST®-enhanced MRA in the diagnosis of clinically significant abdominal or lower limb arterial diseases.

lead_sponsor: Guerbet


title: Multicentric Pilot Study of Dihydropyrimidine Dehydrogenase (DPD) Deficiency for Predicting Capecitabine Toxicity in Breast Cancer Patients

summary:
RATIONALE: Identifying genes that increase a person's susceptibility to side effects caused by capecitabine may help doctors plan better treatment.

PURPOSE: This clinical trial is studying blood samples in predicting response to capecitabine in women with metastatic breast cancer.

lead_sponsor: Centre Antoine Lacassagne


title: Influence of Glitazones on the Vasodilatory Effect of HDL Lipoproteins and on Phospholipase A2

summary:
HDL from patients with type 2 diabetes show a significant reduction of their endothelium-dependent vasodilatory effect.

The primary objective of the study is to analyze whether treatment with glitazones (pioglitazone and rosiglitazone)may improve the endothelium-dependent vasodilatory effect of HDL lipoproteins in patients with type 2 diabetes.

The secondary objectives are:

to analyze the effect of glitazone treatment on phospholipase A2
to look for possible differences between the effects of pioglitazone and those of rosiglitazone
to analyze the glycemic response to glitazone therapy according to clinical and biological baseline characteristics.

ReferenceCitation: Persegol L, Verges B, Foissac M, Gambert P, Duvillard L. Inability of HDL from type 2 diabetic patients to counteract the inhibitory effect of oxidised LDL on endothelium-dependent vasorelaxation. Diabetologia. 2006 Jun;49(6):1380-6. doi: 10.1007/s00125-006-0244-1. Epub 2006 Apr 5.

ReferenceCitation: Verges B, Radu L, Baillot-Rudoni S, Brindisi MC, Poussier A, Bouillet B, Petit JM, Duvillard L. Low HDL-cholesterol: a strong predictor of glycemic response to glitazone treatment in patients with type 2 diabetes. Diabetes Res Clin Pract. 2011 Jul;93(1):e44-8. doi: 10.1016/j.diabres.2011.04.005. Epub 2011 May 6.

lead_sponsor: Centre Hospitalier Universitaire Dijon

location_facility: Service Endocrinologie-diabétologie, Hôpital du Bocage CHU


title: Implication of Metabolic and Genomic Modifications in Elderly Subjects

acronym: COMPALICLAMP

summary:
An increase of longevity and of the number of men and women older than 60 years old is observed in most industrialized countries. Aging is a complex, multifactorial and continuous process involving physical and biological modifications such as a notably decrease in glucose tolerance and type 2 diabetes risk. Insulin sensitivity follow-up during aging is difficult mainly because of many confounding factors (environment, lifestyle).

In 2006, SUVIMAX 2 study began, based on the monitoring of volunteers who participated in former SUVIMAX study (1994-2003). This study was a randomised trial which was designed to study the link between a low antioxidant intake and risk of cancer or ischemic heart disease. The subjects recently had a health check-up including complete information about their diet, physical and neurosensory status. Based on these data, a score was established to classify subjects according to their quality of aging ("successful aging versus "problematic aging") These volunteers, who undertook a 13-year follow-up (dietary and medical status), constitute the reference population to determine the mechanisms involved in the insulin resistance development in aging.

The purpose of our research work is to determine whether the quality of aging could influence insulin sensitivity, by studying metabolic profile and change in gene expression (genes involved in glucose metabolism and metabolic senescence in muscle tissue) during aging.

ReferenceCitation: Betry C, Meugnier E, Pflieger M, Grenet G, Hercberg S, Galan P, Kesse-Guyot E, Vidal H, Laville M. High expression of CPT1b in skeletal muscle in metabolically healthy older subjects. Diabetes Metab. 2019 Apr;45(2):152-159. doi: 10.1016/j.diabet.2018.01.018. Epub 2018 Feb 12.

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

location_facility: Centre de recherche en nutrition humaine Rhône-Alpes


title: Estimation of Microstructure Alteration by MRI in Dementia Among Elderly Subjects Retired From Agricultural Profession and Living in Rural Area in Gironde - Participants From the AMI Cohort.

acronym: AMIMAGE

summary: Capturing the earliest stages of Dementia especially Alzheimer's Disease (AD) is a great challenge. Until now the NINCDS-ADRDA and the DSM criteria for AD were largely used as diagnostic standards in research. However, the research on AD progresses and some biomarkers have been recently suggested to improve the diagnostic criteria of AD, such as cerebrospinal fluid markers, neuroimaging with Positon Emission Tomography (PET) or Magnetic Resonance Imaging (MRI).

location_facility: Groupe Hospitalier Pellegrin - C.H.U. de Bordeaux


title: Acoustic Reflection Method and Work of Breathing : Two New Methods to Measure Children's Upper Airway Obstruction

acronym: MAVAS

summary:
Upper airway obstruction (UAO) is very common in children. Presently, the importance of the UAO is evaluated by the physician during an endoscopic evaluation under general anaesthesia.

The aim of the study is to evaluate two new techniques to quantify the importance of the UAO in children; the acoustic reflection method and the measurement of the work of breathing.

80 children will be included in this monocentric, prospective, open labelled study.

location_facility: Hospital Armand Trousseau, Pediatric Pulmonology department and ENT department


title: Prescription and Utilization of Low Molecular Weight Heparin in Usual Medical Practice for the Curative Treatment of Venous Thromboembolism in Patients With Cancer

summary: The study purpose is to document the prescription and the use of Low Molecular Weight Heparin in usual medical practice in patients with cancer and established Venous Thromboembolism. This study also aims at gathering epidemiological data on the Low Molecular Weight Heparin therapy of Venous Thromboembolism in patients with cancer.


title: Impact of Imipenem With Amikacin Pharmacokinetic and Pharmacodynamic

acronym: IMPACT

summary: The study is a prospective open trial conducted in 4 centers, and designed to determine if pharmacokinetic (PK) and pharmacodynamic (PD) parameters of imipenem, associated with amikacin as empirical therapy, impact microbiological and clinical outcome of patients with Gram negative bacilli (GNB) ventilator-associated pneumonia (VAP).

ReferenceCitation: Burdet C, Pajot O, Couffignal C, Armand-Lefevre L, Foucrier A, Laouenan C, Wolff M, Massias L, Mentre F. Population pharmacokinetics of single-dose amikacin in critically ill patients with suspected ventilator-associated pneumonia. Eur J Clin Pharmacol. 2015 Jan;71(1):75-83. doi: 10.1007/s00228-014-1766-y. Epub 2014 Oct 21.

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - TEL - Thèses en ligne

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Université Jean Moulin Lyon 3

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

publisher_dissemination: Springer

ReferenceCitation: Couffignal C, Pajot O, Laouenan C, Burdet C, Foucrier A, Wolff M, Armand-Lefevre L, Mentre F, Massias L. Population pharmacokinetics of imipenem in critically ill patients with suspected ventilator-associated pneumonia and evaluation of dosage regimens. Br J Clin Pharmacol. 2014 Nov;78(5):1022-34. doi: 10.1111/bcp.12435.

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

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - @rchiveSIC

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

publisher_dissemination: Wiley


title: Acute Effect of Intensive Insulin Infusion on Intestinal Triglyceride-rich-lipoprotein-apoB48 Metabolism in Type 2 Diabetic Patients

summary:
Atherosclerotic cardiovascular disease (ASCD) is the first cause of morbidity and mortality at type 2 diabetes. The typical dyslipidemia that is associated with insulin resistance, which includes a postprandial elevation of triglyceride-rich lipoproteins (TRLs) with excess of intestinal triglyceride-rich-lipoprotein-apoB48 (TRL-apoB48), is felt to play an important role in the accelerated ASCD.

The investigators' objectives in this study are to determine whether an acute elevation of plasma insulin, secondarily to plasma insulin infusion, modulates the production and the clearance rates of intestinal TRL-apoB48 in type 2 diabetic patients in the fed state and to determine if this is a direct effect of insulin or an indirect effect due to the decrease of plasma FFA or the decrease of plasma glucose.

ReferenceCitation: Nogueira JP, Maraninchi M, Beliard S, Padilla N, Duvillard L, Mancini J, Nicolay A, Xiao C, Vialettes B, Lewis GF, Valero R. Absence of acute inhibitory effect of insulin on chylomicron production in type 2 diabetes. Arterioscler Thromb Vasc Biol. 2012 Apr;32(4):1039-44. doi: 10.1161/ATVBAHA.111.242073. Epub 2012 Feb 2.

lead_sponsor: Assistance Publique Hopitaux De Marseille

location_facility: Assistance Publique-Hopitaux de Marseille


title: Prevalence of Obstructive Sleep Apnoea in Patients With Intermittent Claudication

acronym: WITH-SAS

summary: The main aim of this study is to determine how common undiagnosed obstructive sleep apnoea is in individuals with intermittent claudication.

time_perspective: Other

lead_sponsor: University Hospital, Angers


title: Phase 2b Clinical Study Evaluating Efficacy and Safety of TAR-200 in Combination With Cetrelimab, TAR-200 Alone, or Cetrelimab Alone in Participants With High-Risk Non-Muscle Invasive Bladder Cancer (NMIBC) Unresponsive to Intravesical Bacillus Calmette-Guérin (BCG) Who Are Ineligible for or Elected Not to Undergo Radical Cystectomy

summary: The purpose of this study is to evaluate the overall complete response (CR) rate in participants treated with TAR-200 in combination with cetrelimab (Cohort 1), or TAR-200 alone (Cohort 2), or cetrelimab alone (Cohort 3) with Carcinoma in Situ (CIS), with or without concomitant high-grade Ta or T1 papillary disease; and disease-free survival (DFS) in participants treated with TAR-200 alone with papillary disease only (Cohort 4).

status: Recruiting

ipd_sharing: Yes

ipd_sharing_description: The data sharing policy of the Janssen Pharmaceutical Companies of Johnson and Johnson is available at www.janssen.com/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) project site at yoda.yale.edu

lead_sponsor: Janssen Research & Development, LLC

location_country:
Germany
Italy
Portugal
United Kingdom
Australia
Japan
Netherlands
Belgium
United States
Korea, Republic of
Spain
Greece
Canada
Ukraine
Russian Federation
France

location_facility: Azienda Ospedaliera Universitaria Citta della Salute e della Scienza di Torino

location_facility: 'Papageorgiou' General Hospital of Thessaloniki

location_facility: Studienpraxis Urologie Nürtingen - Germany

location_facility: University of Texas Southwestern Medical Center

location_facility: The Julius Center - Utrecht Science Park - Stratenum

location_facility: Urologische Praxis am Wasserturm - Germany

location_facility: Institut de Cancerologie Strasbourg Europe (ICANS)

location_facility: Chernihivskyi oblasnyi onkolohichnyi dyspanser

location_facility: Groupe Hospitalier Diaconesses Croix Saint Simon

location_facility: Instituto Portugues de Oncologia do Porto Francisco Gentil

location_facility: Multifunctional clinical medical center 'Medical city'

location_facility: General Hospital of Thessaloniki G. Gennimatas

location_facility: BHI of Omsk region Clinical Oncology Dispensary

location_facility: Urological Associates of Southern Arizona, P.C.

location_facility: Pusan National University Yangsan Hospital

location_facility: Urologic Consultants of Southeastern Pennsylvania

location_facility: A. Tsyb Medical Radiological Research Center

location_facility: Centro Hospitalar de Vila Nova de Gaia Espinho E P E

location_facility: Azienda Ospedaliera Universitaria Careggi

location_facility: Polyclinique de Limoges - Francois Chenieux

location_facility: Centro Hospitalar de Trás os Montes e Alto-Douro

location_facility: The Catholic University of Korea Seoul St. Mary's Hospital

location_facility: Kyungpook National University Chilgok Hospital

location_facility: Azienda Ospedaliero Universitaria Pisana