title: Maintenance of an Antiaggregation by Acetylsalicylic Acid, Less or Equal to 250mg While a Extracorporeal Lithotripsy (ECL) Session on a Kidney Stone is Perfomed: Comparative Unicentric Prospective Study

acronym: KARLITHO

summary:
Background/Rationale for the study:

Lithiasis pathology is increasingly common because of the change in our lifestyle and our food. Thus, we hold a prevalence for urinary lithiasis 10% in France currently including 13% of the male population and 6% of the female population.

The formation of urinary lithiasis is the result of a complex mechanism involving factors anatomical and infectious metabolics. They are classified according to their size, topography and composition.

The treatment of urinary lithiasis has changed dramatically in recent years. The recommendations of the French Urology Association (AFU) for the management of kidney stones and ureteral of the adult of 2004 give a certain place to the treatment by extracorporeal lithotripsy (ECL).

The ELC is indicated for the first purpose for lithiasis ureteral or renal lithiasis of less than 20 mm, whether or not associated with the setting up of a JJ stent. For kidney stones of more than 20 mm or complex or Coralliformes, the ECL can be associated with treatment with percutaneous nephrolithotomy. In addition, the ECL is indicated in case of residual cholelithiasis 3 months after a first treatment whatsoever.

It is found, as the main complication of the ECL, a risk of the appearance of Hematomas under capsular, peri-renal and intra-parenchymatous. Its prevalence is estimated to be between 6.2% and 13% according to studies.

ACETYLSALICYLIC ACID less or equal to 250 mg is the usual dosage of aspirin (for the adult), the Marketing Autorisation recognises in secondary prevention after a first myocardial or cerebral ischemic attack related to atherosclerosis. It entrains a reduction mortality and morbidity of cardiovascular causes.

Acetylsalicylic acid is currently being stopped 5 to 7 days before the ECL. The interest of maintaining the Acetylsalicylic acid is:

A simplification of the management of patients under on acetylsalicylic acid below (or equal to) 250 mg (No modification of Treatment to be implemented)
A cardiovascular risk decreased by maintaining their initial treatment without any modification.

Main objective:

Evaluation of the proportion of renal hematoma during the production of Lithotripsy for renal lithiasis, on a 15-day scan, in patients under on acetylsalicylic acid below (or equal to) 250 mg not stopped

Secondary objectives:

Evaluation of the efficacy of treatment with lithotripsy (Stone free, fragments Minimal residuals) Evaluation of the proportion of hematuria macroscopic post lithotripsy in Patients under on acethylsalicylic acid not stopped. Evaluate the rate of post-ECL complications requiring treatment, Analgesic, obstructive pyelonephritis.

Evaluate post-ECL pain due to hematoma or lithiasis migration Evaluation of the evolution of renal function post session of Lithotripsy on the patients under acethylsalicylic acid not stopped.

Type of Study: Interventional study, prospective, mono centric, single-arm

primary_purpose: Health Services Research

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ReferenceCitation: Burger W, Chemnitius JM, Kneissl GD, Rücker G. Low-dose aspirin for secondary cardiovascular prevention - cardiovascular risks after its perioperative withdrawal versus bleeding risks with its continuation - review and meta-analysis. J Intern Med. 2005 May;257(5):399-414. Review.

ReferenceCitation: Ueda S, Matsuoka K, Yamashita T, Kunimi H, Noda S, Eto K. Perirenal hematomas caused by SWL with EDAP LT-01 lithotripter. J Endourol. 1993 Feb;7(1):11-5.

ReferenceCitation: Oscarsson A, Gupta A, Fredrikson M, Järhult J, Nyström M, Pettersson E, Darvish B, Krook H, Swahn E, Eintrei C. To continue or discontinue aspirin in the perioperative period: a randomized, controlled clinical trial. Br J Anaesth. 2010 Mar;104(3):305-12. doi: 10.1093/bja/aeq003.

ReferenceCitation: Ferrari E, Benhamou M, Cerboni P, Marcel B. Coronary syndromes following aspirin withdrawal: a special risk for late stent thrombosis. J Am Coll Cardiol. 2005 Feb 1;45(3):456-9.

ReferenceCitation: Collet JP, Montalescot G, Blanchet B, Tanguy ML, Golmard JL, Choussat R, Beygui F, Payot L, Vignolles N, Metzger JP, Thomas D. Impact of prior use or recent withdrawal of oral antiplatelet agents on acute coronary syndromes. Circulation. 2004 Oct 19;110(16):2361-7. Epub 2004 Oct 11.

ReferenceCitation: Telegrafo M, Carluccio DA, Rella L, Ianora AA, Angelelli G, Moschetta M. Diagnostic and prognostic role of computed tomography in extracorporeal shock wave lithotripsy complications. Urol Ann. 2016 Apr-Jun;8(2):168-72. doi: 10.4103/0974-7796.163792.

lead_sponsor: University Hospital, Clermont-Ferrand


title: A Randomized, Double-blind Comparison of Morphine and Sufentanil for Treatment of Prehospital Traumatic Severe Acute Pain.

summary: Obtaining high-quality analgesia in prehospital patients with severe pain is an important treatment objective for medical team. Opioids are recognized as the treatment of choice for relief of severe acute pain. Recommended initial analgesia of patients with severe acute pain, defined as a visual analog scale or a numerical rating scale (NRS) score of 60/100 or higher, in a prehospital setting in France consists of the administration of opioids by the medical staff of mobile intensive care units. The intravenous administration of morphine is usually considered as the gold standard for postoperative acute pain relief because of its rapid transport from the blood to target tissues after intravenous injection, its long-lasting analgesic effect without any plateau, and its well-known pharmacokinetics. Nevertheless, the short-acting opioid sufentanil might be preferable to the traditional long-acting morphine for prehospital analgesia because of its even faster onset of action and shorter duration than morphine. There is no study, to our knowledge, comparing the clinical efficacy of sufentanil vs morphine in a prehospital setting. This randomized double-blind group clinical trial is designed to determine the best intravenous opioid titration protocol by comparing sufentanil and morphine for medical prehospital treatment of adult patients with severe acute pain. Eligible patients with a numerical rating scale (NRS) score of 60/100 or higher will be randomly allocated to receive either 0.15 µg/kg sufentanil then 0.075 µg/kg every 3 minutes (group A) or 0.15 mg/kg morphine then 0.075 mg/kg every 3 minutes (group B) intravenously. The decision to provide opioid analgesia including titration of subsequent doses of narcotic is the responsibility of physicians and intravenous analgesia will be given and titrated according to the pain score every 3 minutes. The drugs will be administered by the physician from syringes of similar appearance prepared by the nurse who is not otherwise involved in the study. The protocol-defined primary outcome measure is the percentage of patients with pain relief (with a NRS score of 30/100 or lower) 15 minutes after the first injection. Secondary outcomes include pain score comparisons every 3 minutes within the first 30 minutes and comparison of adverse events. The physician blinded to the analgesic treatment groups will do all assessments of patients. The safety evaluation will include non invasive monitoring of blood pressure, heart rate, respiratory rate, oxygen saturation by pulse oximetry (Spo2), and a sedation scale (0, patient is awake; 1, patient is with intermittent sleeping; 2, patient is sleeping, awakened by verbal stimulation; 3, patient is sleeping, awakened by tactile stimulation; 4, patient is not aroused by stimulation) at these periods. Fifteen minutes after the first injection, overall patient and investigator satisfaction with analgesia was recorded.

status: Completed

study_completion_date_type: Actual

study_type: Interventional

design_allocation: Randomized

primary_purpose: Treatment

enrollment_type: Actual

ReferenceType: result

ReferenceCitation: Bounes V, Barthélémy R, Diez O, Charpentier S, Montastruc JL, Ducassé JL. Sufentanil is not superior to morphine for the treatment of acute traumatic pain in an emergency setting: a randomized, double-blind, out-of-hospital trial. Ann Emerg Med. 2010 Nov;56(5):509-16. doi: 10.1016/j.annemergmed.2010.03.020. Epub 2010 Apr 10.

family: Bounes

full_name: Vincent Bounes

given: Vincent

sequence: first

family: Barthélémy

full_name: Romain Barthélémy

given: Romain

sequence: additional

family: Diez

full_name: Olivier Diez

given: Olivier

family: Charpentier

full_name: Sandrine Charpentier

given: Sandrine

family: Montastruc

full_name: Jean Louis Montastruc

given: Jean Louis

family: Ducassé

full_name: Jean Louis Ducassé

bso_classification: Medical research

datasource: user

genre: journal-article

genre_raw: journal-article

journal_name: Annals of Emergency Medicine

publisher: Elsevier BV

publisher_dissemination: Elsevier

publisher_group: Elsevier

publisher_normalized: Elsevier

title: Sufentanil Is Not Superior to Morphine for the Treatment of Acute Traumatic Pain in an Emergency Setting: A Randomized, Double-Blind, Out-of-Hospital Trial

ipd_sharing: No

lead_sponsor: University Hospital, Toulouse

intervention_type: Drug

lead_sponsor_type: academique

status_simplified: Completed


ReferenceType: background

ReferenceCitation: Moorlag SJCFM, Arts RJW, van Crevel R, Netea MG. Non-specific effects of BCG vaccine on viral infections. Clin Microbiol Infect. 2019 Dec;25(12):1473-1478. doi: 10.1016/j.cmi.2019.04.020. Epub 2019 May 2. Review.

ReferenceCitation: Nemes E, Geldenhuys H, Rozot V, Rutkowski KT, Ratangee F, Bilek N, Mabwe S, Makhethe L, Erasmus M, Toefy A, Mulenga H, Hanekom WA, Self SG, Bekker LG, Ryall R, Gurunathan S, DiazGranados CA, Andersen P, Kromann I, Evans T, Ellis RD, Landry B, Hokey DA, Hopkins R, Ginsberg AM, Scriba TJ, Hatherill M; C-040-404 Study Team. Prevention of M. tuberculosis Infection with H4:IC31 Vaccine or BCG Revaccination. N Engl J Med. 2018 Jul 12;379(2):138-149. doi: 10.1056/NEJMoa1714021.

ReferenceCitation: Kowalewicz-Kulbat M, Locht C. BCG and protection against inflammatory and auto-immune diseases. Expert Rev Vaccines. 2017 Jul;16(7):1-10. doi: 10.1080/14760584.2017.1333906. Epub 2017 May 30. Review.

ReferenceCitation: Netea MG, Domínguez-Andrés J, Barreiro LB, Chavakis T, Divangahi M, Fuchs E, Joosten LAB, van der Meer JWM, Mhlanga MM, Mulder WJM, Riksen NP, Schlitzer A, Schultze JL, Stabell Benn C, Sun JC, Xavier RJ, Latz E. Defining trained immunity and its role in health and disease. Nat Rev Immunol. 2020 Jun;20(6):375-388. doi: 10.1038/s41577-020-0285-6. Epub 2020 Mar 4. Review.

intervention_type: Other

status: Recruiting

study_start_date_type: Actual

lead_sponsor: Assistance Publique - Hôpitaux de Paris

enrollment_type: Anticipated

primary_purpose: Prevention

acronym: COVID-BCG

study_completion_date_type: Anticipated

type: EudraCT Number

source: euctr

title: Randomized Controlled Trial Evaluating the Efficacy of Vaccination With Bacillus Calmette and Guérin (BCG) in the Prevention of COVID-19 Via the Strengthening of Innate Immunity in Health Care Workers

summary: Healthcare Workers (HCW) are at high risk for COVID-19. In addition to the risk of serious forms among HCW, significant absenteeism due to illness would have dramatic consequences in our ability to fight COVID-19. No coronavirus vaccine is available today and drug treatments are only at the start of clinical evaluation. Available since 1921, the bacillus Calmette and Guérin (BCG) is the most widely used vaccine in the world (> 3 billion doses administered) with an extremely low rate of adverse effects. BCG is indicated for the prevention of tuberculosis (TB), but more recent studies have shown that it also has nonspecific immune properties which may be interesting in the current COVID-19 epidemic. Data in mice and in humans have demonstrated protection conferred by BCG against viral respiratory infections such as influenza. In countries with high endemic TB, BCG decreases the incidence of acute respiratory infections by up to 80%, neonatal BCG vaccination has been shown to greatly reduce the risk of sepsis and of hospitalization of children for reasons other than TB. A recent study conducted in South Africa showed that re-vaccination with BCG in adults reduced the incidence of respiratory infections by 70% compared to unvaccinated controls. Beyond respiratory infections, BCG has also shown protective effects against inflammatory diseases. These non-specific beneficial effects are likely linked to the induction of "trained innate immunity", implying epigenetic and metabolic re-programming of innate immune cells. It is therefore possible that revaccination with BCG could significantly reduce the incidence and severity of COVID-19. Very recent ecological observations indeed suggest an inverse correlation between BCG vaccination coverage and the morbidity and mortality of COVID-19. In this context several trials began in Europe and Australia to evaluate the efficacy of BCG vaccination in populations at risk of exposure (HCW) or severe disease (elderly). This study is aligned with studies carried out in Australia, The Netherlands and Spain. In contrast to these latter studies, virtually all French study participants have been vaccinated in their childhood, since BCG vaccination was mandatory in France in neonates until 2007, and in HCW until recently. Therefore, the French study will be in a unique situation to evaluate the effect of re-vaccination with BCG in the context of BCG priming decades before revaccination.

status_simplified: Ongoing


ReferenceCitation: Omenaca F, Sarlangue J, Szenborn L, Nogueira M, Suryakiran PV, Smolenov IV, Han HH; ROTA-054 Study Group. Safety, reactogenicity and immunogenicity of the human rotavirus vaccine in preterm European Infants: a randomized phase IIIb study. Pediatr Infect Dis J. 2012 May;31(5):487-93. doi: 10.1097/INF.0b013e3182490a2c.

ReferenceCitation: Omenaca F et al. Immunogenicity of a rotavirus vaccine (RIX4414) in European pre-term infants with different gestational age. Abstract presented at the 27th annual ESPID meeting, Brussels, Belgium, 9-13 June 2009.

ReferenceCitation: Omenaca F et al. Safety, Reactogenicity and Immunogenicity of RIX4414 Live Attenuated Human Rotavirus Vaccine in Pre-Term Infants. Abstract presented at the ICAAC/IDSA Joint Meeting, Washington DC, US, 25-28 October 2008.

intervention_type: Biological

ipd_sharing_description: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

lead_sponsor: GlaxoSmithKline

location_country: Spain France Portugal Poland

ipd_sharing: Yes

title: Phase IIIb, Double Blind, Randomised, Placebo-Controlled, Multi-Country/Centre, Study to Assess Safety, Reactogenicity & Immunogenicity of 2 Doses of GSK Biologicals' Oral Live Attenuated Human Rotavirus (HRV) Vaccine in Pre-Term Infants

summary: This study is planned to evaluate the safety (in terms of occurrence of any serious adverse events), reactogenicity (any side effects) and immunogenicity (ability of the vaccine to develop antibodies that fight infection) of the HRV vaccine when used in pre-term infants aged between 6 and 14 weeks at the time of the first dose in Portugal, France and Poland and in pre-term infants aged between 6 and 12 weeks at the time of first dose in Spain. The study will be performed in four European countries (France, Poland, Spain, and Portugal). The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.

lead_sponsor_type: industriel


type: Other Identifier

acronym: Fib-Auric

summary:
Fibromyalgia (FM) is the most common cause of diffuse pain in the bones and joints, and one of the most frequent causes of referral to the pain management unit. It affects mainly women; they are referred by a rheumatologist, an internal medicine physician or by their family physician.

FM produces various degrees of disability and pain, and has an important impact on quality of life. Sleep disorders, fatigue and cognitive dysfunctions are almost always part of the clinical presentation. The wide range of symptoms and signs, the unknown etiology, the lack of efficacy of pharmacological treatments make management of FM a very difficult task. In France the consensus includes limitation of pharmacological treatment, encouraging physical rehabilitation and referring the patients to a specialized pain clinic where multidisciplinary management will be undertaken. In our hospital the investigators favor non pharmacological therapies and propose to the FM patients to learn relaxation and self-hypnosis, physical rehabilitation and use of trans cutaneous electrical neurostimulation.

Auriculotherapy (AT) is a complementary therapy, based on the idea that the ear is a microsystem which reflects the entire body, represented on the auricle, the outer portion of the ear. Mapping of the auricle has been described, according to the fact that pathology of different organs can induce specific changes in the auricle, for example color change or sensitivity. Treating specific areas, which somehow would be "connected" to the affected organ could also improve the functioning of the body or relieve pain. AT uses placement of needles at points tailored to the patient's pathology. Whatever the mechanisms involved, the effectiveness of ATis currently supported by randomized controlled trials. It is validated by WHO since 1987, mapped in an international nomenclature initially proposed by Nogier.

The investigators regularly use AT in FM patients in our pain management unit to alleviate symptoms as pain, sleep disorders, anxiety. The investigators established a clinical trial in this population to assess impact of FM (assessed with Fibromyalgia Impact Questionnaire) following 3 months of AT management (Primary Outcome). Sleep disorder, fatigue, anxiety and depression, cognitive and physical dysfunction are also evaluated as secondary outcomes. The remnant effect of AT is also evaluated, 3 month after the end of the treatment by the same tests.

lead_sponsor: Hopital Foch


type: Registry Identifier

title: EVALUATION OF THE SAFETY AND EFFICACY OF ADJUSTABLE CONTINENT THERAPY FOR THE MANAGEMENT OF NEUROGENIC INCONTINENCE IN CHILDREN WITH SPINAL DYSRAPHISM.

acronym: BPUA

summary:
Urinary continence is still a difficult goal to achieve in neurogenic bladder patients. Conservative treatment of neurogenic urinary incontinence using clean intermittent catheterization in conjunction with pharmacological therapy, notably anticholinergic medication +/- adrenergic agents, may produce continence in a variable number of patients. In other patients, reconstructive surgery of the bladder and/or bladder neck is necessary to achieve urinary continence. Surgical treatment options to increase bladder outlet resistance in patients with neurogenic bladder include injection of bulking agents around the bladder neck, bladder neck reconstruction, fascial sling procedures and Artificial Urinary Sphincter.

The Adjustable Continence Therapy system (ACT) or periurethral adjustable balloons are a minimally invasive device consisting of two volume-adjustable balloons implanted periurethrally at the bladder neck as a method of augmenting titration for urethral coaptation. Adjustable means that such system would be adaptable to the individual clinical condition.

Originally conceived and developed as a treatment for female stress urinary incontinence, the technique has been then adapted and balloons were globally developed for the use in postprostatectomy incontinence. The published success rate in male after prostatectomy and in women was respectively 56 to 92% and 60 to 83%.

The investigators hypothesize that the use of ACT for treating incontinence in children secondary to neurogenic sphincter incontinence could compress the urethra or the bladder neck, acting as an extrinsic occlusive system increasing passive and dynamic urethral and bladder resistance.

Goal of the study:

To prospectively assess the efficacy and safety of periurethral adjustable balloons in the treatment of neurogenic incontinence in children with spinal dysraphism.

Material and methods :

A prospective study will be performed at La Timone Enfants hospital and La Nord hospital in Marseille, France. Boys and girls at least at school age (5 or 6 years) with neurogenic incontinence due to outlet issues (low detrusor leak point pressure and low stress leak point pressure) with spinal dysraphism will be recruited.

The ACT balloon is an implantable medical device developed and furnished for free by Uromedica (Irvine, CA, USA). The procedure is performed under general anaesthesia using the same implantation technique as published in adult population.

study_start_date_type: Anticipated

status: Not yet recruiting

lead_sponsor: Assistance Publique Hopitaux De Marseille

location_facility: Assistance Publique Hopitaux de Marseille

intervention_type: Device


title: Interest of Respiratory Tele Monitoring in COVID-19 Pneumonia

summary:
The determinants of the evolution to a severe form for COVID-19 pneumonia remain unclear. COVID-19 pneumonia is characterized by a hypoxemia with a possible rapid worsening and related resuscitation requirement. The monitoring of patients in hospital wards (excluding intensive care unit) is therefore both necessary and complicated given the contagious risks for health workers.

The COVID 19 Respiratory Tele Monitoring (RTM COVID 19) research project is based on a comparison between usual nurse respiratory monitoring (4 to 6 time per day) of respiratory parameters (capillary oxygen saturation, respiratory rate, hearth rate) and a continuous monitoring of these respiratory parameters with continuous monitoring by a portable, wireless and stand-alone device.

The main objective of this work is a more sensitive and earlier detection of respiratory degradation events in patients with COVID-19 pneumonia (capillary desaturation, increased respiratory rate) requiring the introduction of oxygen therapy, its increase or a resuscitation requirement with possible intensive care admission.

A prospective, randomized, multicentre, comparative exposure study will be conducted with planned inclusion of 80 patients. This investigation will focus on patients with COVID-19 pneumonia hospitalized in dedicated medical wards of two University Hospitals in France.

A randomization will be stratified by Hospital and adapted so that each Hospital provides the same number of subjects in each arms:

Control Respiratory Monitoring Group (40 patients)
Experimental Respiratory Monitoring Group (40 patients)

The main criterion is respiratory degradation event, during a 4 days period after ward admission, which motivates a change in the therapeutic strategy defined by the presence of at least one of these elements:

Capillary saturation < 94% (regardless of oxygen intake) for at least 2 minutes.
And/or an increase in respiratory rate > 20/minute for at least 2 minutes.

The modification of the therapeutic strategy is defined by:

Introduction of oxygen therapy for included patients without oxygen therapy or supplementation of oxygen therapy > 2 litres/minutes for included patients with oxygen therapy
And/or introduction of a high oxygen concentration mask
And/or Request an On-Site Opinion from a member of the resuscitation team.
And/or Transfer to intensive care or resuscitation unit
And/or Need for immediate resuscitation for life-threatening distress.

primary_purpose: Supportive Care

location_facility: Assistance Publique Hôpitaux de Marseille


title: Non Invasive Measurements of Fibrosis, Inflammation and Steatohepatitis in Morbidly Obese Patients

acronym: FIRM

summary:
Abstract:

Fatty liver most frequently corresponds to a fat overload of the liver. It is usually classified as alcoholic steatosis or non-alcoholic steatosis. In the case of non alcoholic fatty liver overload, the histological spectrum ranges from simple steatosis to steatohepatitis (NASH) which associates inflammation to steatosis, with a risk of progression to fibrosis and cirrhosis. Obese patients are at particular risk of NASH. Screening of these hepatic lesions is difficult especially as they may exist while the liver tests are normal. The diagnosis of NASH is currently done by liver biopsy, which exposes them in particular to the risk of hemorrhagic complications.

Number of subjects required:

According to the literature and data collected Louis Mourier in the recent years, the inclusion of 200 patients would examine 20-40 patients with severe histological steatosis and steatohepatitis. All patients will be included in Louis Mourier hospital.

Follow-up: one month Search duration: 37 months Duration inclusions: 36 months The total duration of participation for a patient will be one month.

Methodology:

It is a monocentric, prospective study evaluating the value of noninvasive tests for the diagnosis of hepatic lesions in morbid obese patients. The "open " MRI system allows access to MRI for all obese patients (maximum weight 250 kg). Three of such systems are available in France and liver pathology can be explored only on the system of Louis Mourier.

The reference method is liver histology; studied tests are abdominal MRI, Fibroscan / CAP, and serum tests.

Examinations required specifically for research Examinations required specifically for the research is abdominal MRI, FibroScan/ CAP and serum tests.

Primary endpoint :

To validate the use of abdominal MRI, the FibroScan/ CAP and serum tests for finding severe steatosis and / or NASH, specificity, sensitivity, positive and negative predictive values of these tests are calculated. The gold standard is the result of histology on liver biopsy, with a morphometric study of these parameters. ROC curves are used to determine the best compromise between sensitivity and specificity.

The secondary endpoints were:

Histological lesions of liver fibrosis. Quantification of abdominal fat by MRI (in the form of three variables of interest: quantification of the surface of the visceral fat, of subcutaneous fat and of intrahepatic fat assessed by the percentage loss of signal

study_type: Observational

time_perspective: Prospective


title: Study of Volumetric, Radiomic and Anthropometric Characteristics in Trimodal Imaging (Positron Emission Tomography, Computed Tomography, Magnetic Resonance Imaging) Before Radiotherapy

acronym: TRIMODAL

summary:
In oncology, personalized medicine is progressing by providing increasingly tumor- and patient-specific care. Thus, medical imaging allows precise morphological and functional characterization of the tumor by volume measurements, used in particular in radiotherapy to define the macroscopic tumor volume (GTV), and radiomic measurements that correspond to a recent concept of extraction of textural parameters and/or tumor shape (tumor heterogeneity, tumor invasiveness...). Precise characterization of the patient is also possible by anthropometric measurements (measurements of total muscle mass, visceral adipose tissue mass...) which can be important predictive and prognostic factors and which are generally estimated more accurately in imaging than by using mathematical formulas.

However, these measurements are partly dependent on the imaging acquisition mode (PET, CT or MRI). The volume measurements, and therefore the GTV, are thus different depending on the imaging used. Studying these differences is important because no single imaging technique encompasses all potential GTV regions but, on the other hand, a combination of anatomical and functional information could improve tumor delineation. Beyond this volume analysis, the extraction of radiomic characteristics seems very promising in radiotherapy with however many limitations to be overcome, linked in particular to the data acquisition mode. Concerning anthropometric measurements, CT and MRI have become essential techniques for precise anatomical quantification, particularly of lean mass, visceral adipose tissue or muscle mass, but automatic measurement techniques for these parameters have yet to be defined, particularly during CT or MRI acquisitions associated with PET for attenuation correction.

To identify useful volume, radiomic and anthropometric characteristics, medical imaging thus requires prospective cohorts of patients with comparable cancer histologies and standardized images acquired by different modalities (e. g. PET, CT or MRI) during the pre-treatment assessment before similar treatments.

The purpose of this study is to create a prospective cohort to study volume, radiomic and anthropometric characteristics by taking advantage of the recent installation of MRI in the medical imaging department of the Henri Becquerel Cancer Center (HBCC), Rouen, France, allowing PET/MRI to be performed and by taking advantage of the collaboration between the radiotherapy and medical imaging departments of the HBCC.

primary_purpose: Basic Science

lead_sponsor: Centre Henri Becquerel


title: Randomized Multicenter Open-Label, Pilot Trial to Evaluate the Efficacy and Safety of Switching HIV-1 Stable Infected Patients Under HAART to a New Once Daily Triple Therapy Combination Including EFV+3TC+TDF Versus a Dual QD Therapy Containing EFV+TDF

acronym: COOL

summary:
Primary objective: Evaluation of the efficacy of TDF+3TC+EFV versus TDF+EFV QD to maintain plasma HIV-1 RNA BLQ (< 50 copies/mL) (c/mL) at 48 weeks (W48)

Main Secondary objectives:

Comparison of the two arms for genotypic resistance profile in case of virological failure

CD4 changes from baseline

Evolution of the lipid profile and morphological changes in fat distribution, and safety

Efficacy and genotypic profile data, results of lipid markers, morphological changes and main biological parameters

lead_sponsor: Gilead Sciences


title: True Ileal Amino Acid Digestibility of Whey and Zein Proteins in Healthy Volunteers With Naso-ileal Tubes

summary: The main goal of the study is to determine true ileal amino acid digestibility of whey protein isolate (WPI) and zein proteins in healthy subjects equipped with naso-ileal tube. The endogenous losses of proteins and amino acids will be determined by collecting digesta samples after a protein-free diet in a third group of subjects.

status: Active, not recruiting

ReferenceType: derived

ReferenceCitation: Calvez J, Benoit S, Piedcoq J, Khodorova N, Azzout-Marniche D, Tomé D, Benamouzig R, Airinei G, Gaudichon C. Very low ileal nitrogen and amino acid digestibility of zein compared to whey protein isolate in healthy volunteers. Am J Clin Nutr. 2020 Oct 6. pii: nqaa274. doi: 10.1093/ajcn/nqaa274. [Epub ahead of print]

name: Université Paris-Saclay, AgroParisTech, National Research Institute for Agriculture, Food and Environment (INRAE), Nutrition Physiology and Ingestive Behavior UMR (unité mixte de recherche) (UMR PNCA), Paris, France

family: Calvez

full_name: Juliane Calvez

given: Juliane

family: Benoit

full_name: Simon Benoit

given: Simon

family: Piedcoq

full_name: Julien Piedcoq

given: Julien

family: Khodorova

full_name: Nadezda Khodorova

given: Nadezda

family: Azzout-Marniche

full_name: Dalila Azzout-Marniche

given: Dalila

family: Tomé

full_name: Daniel Tomé

given: Daniel

family: Benamouzig

full_name: Robert Benamouzig

given: Robert

family: Airinei

full_name: Gheorghe Airinei

given: Gheorghe

family: Gaudichon

full_name: Claire Gaudichon

given: Claire

bso_classification: Biology (fond.)

journal_name: The American Journal of Clinical Nutrition

publisher: Oxford University Press (OUP)

publisher_dissemination: Oxford University Press

publisher_group: Oxford University Press

publisher_normalized: Oxford University Press

ipd_sharing: Undecided

lead_sponsor: Institut National de la Recherche Agronomique


title: Adaptation to Neonatal Life After an Anesthetic Protocol Using Remifentanil for General Anesthesia for Caesarean Section in a Context of Prematurity - REAGI Protocol

acronym: REAGI

summary:
One of the problems during general anesthesia (GA) for caesarean section is the place of opioid agents. Indeed, the literature does not provide so far a clear answer regarding the use of opioids prior to extraction of the newborn. Indeed, if the opioid administration at induction is beneficial for the mother (better control of autonomic responses to noxious stimuli), the impact on the newborn can be unfavorable in terms of adaptation to extrauterine life . This is especially true if the birth takes place in a context of prematurity and / or acute fetal distress.

The pharmacokinetics of remifentanil make it the only opioid which is consistent with a rapid sequence induction. Its short period of action avoids the manual ventilation of patients before intubation, while providing a peak of action concomitant to the nociceptive stimulation. Patients at high risk of aspiration, including pregnant women, may benefit from this type of morphine at induction. In addition, the fact that remifentanil seems to be associated with relative fetal safety in obstetrical or neonatal context legitimized the development of protocols to study maternal-fetal consequences of the use of remifentanil at induction of AG for emergency caesarean section.

While cesarean section under general anesthesia mainly concern premature newborns in France, no work has focused on the use of remifentanil for caesarean section in a context of preterm without preeclampsia.

The main hypothesis of this study is to evaluate the safety of the use of remifentanil in terms of adaptation to extrauterine life in children born prematurely by caesarean section under general anesthesia outside the context of preeclampsia.

To do this, we will compare two groups of children, one consisting of children born by cesarean section under general anesthesia with maternal remifentanil infusion, the other made up of children born by cesarean section under general anesthesia without maternal infusion of remifentanil. This study is prospective, single-center, randomized, double-blinded.

The primary endpoint is formed by the value of the Apgar score less than 7 at 5 minutes, calculated in the delivery room by the team supporting the child (midwives and pediatricians).

The secondary endpoints are formed by maternal hemodynamic parameters (SBP, DBP, MAP, HR), the rate of complications during induction (difficult intubation, aspiration), the onset of respiratory distress requiring ventilation mask in the newborn, the rate of intubation in neonates, and the rate of use of adjuvant anesthetic agents.

status: Unknown status

lead_sponsor: University Hospital, Rouen

status_simplified: Unknown


title: Study of Abnormalities of the Vegetative Nervous System in the Occurrence of Intradialytic Arterial Hypotension

acronym: SUDHEMO

summary:
Intradialytic hypotension is a common complication of hemodialysis sessions in patients with chronic renal failure, with an estimated prevalence of 10 to 30%. This hypotensopn is classically defined by a decrease in systolic blood pressure greater than 30 mmHg associated with clinical signs (cramps, abdominal pain, unconsciousness, convulsions). Its repetition is correlated with cardiovascular events, neurological events and excess mortality. Several clinical factors have been proposed to predict the risk of intradialytic hypotension such as age, certain comorbidities (diabetes, ischemic heart disease...), dialysis modalities (hemodialysis), ultrafiltration, conductivity but also alterations of the autonomic nervous system (especially the sympathetic system).

In recent years, the study of vegetative functions has been facilitated by the use of SUDOSCAN® (Impeto, Paris, France) which is a simple, non-invasive tool that allows the study of Chlorine conductance directly reflecting the activity of small non-myelinated C fibers that innervate the sweat glands. SUDOSCAN® has shown good sensitivity and specificity in the diagnosis of vegetative damage in diabetic patients and also a good correlation with cardiac autonomic neuropathy. More recently, SUDOSCAN® has shown good sensitivity in the detection of neuropathies small fibers especially in diabetic patients. This sensitivity is comparable to QST-type quantitative tests and the correlation with cardiovascular dysautonomia tests is good. This test, simple and fast realization, does not require the active participation of the patient. There is a good correlation between the results of SUDOSCAN® and the reduction of intra-dermal fiber density at cutaneous biopsy.

Hemodialysis patients are at risk of peripheral neurological involvement not only because of an increasing incidence of diabetes (30-40%) but also because of the abnormal production and elimination of certain uremic toxins. Few studies exist on the anomalies of the vegetative system in hemodialysis. A recent publication has suggested a difference in nerve excitability depending on the type of hemodialysis suggesting nerve changes secondary to ionic changes. The identification of patients at risk of intradialytic hypotension during dialysis sessions could be useful for adapting hemodialysis protocols.

Patients will be classified into 2 groups according to the occurrence of intradialytic hypotension. Group 1 corresponds to patients with intradialytic hypotension and group 2 corresponds to patients without intradialytic hypotension.

design_allocation: Non-Randomized

ReferenceCitation: Reach P, Touzot M, Lombardi Y, Maheas C, Sacco E, Fels A, Beaussier H, Ureña-Torres P, Chatellier G, Ridel C, Zuber M. Electrochemical skin conductance by Sudoscan®: a new tool to predict intradialytic hypotension. Nephrol Dial Transplant. 2021 Jul 23;36(8):1511-1518. doi: 10.1093/ndt/gfab183.

name: Service de Neurologie, Groupe Hospitalier Saint-Joseph, Paris, France

family: Reach

full_name: Pauline Reach

given: Pauline

name: AURA Paris Plaisance, Dialyse et Aphérèse Thérapeutique, Paris, France

family: Touzot

full_name: Maxime Touzot

given: Maxime

family: Lombardi

full_name: Yannis Lombardi

given: Yannis

family: Maheas

full_name: Catherine Maheas

given: Catherine

name: Centre de Recherche Clinique, Groupe Hospitalier Saint-Joseph, Paris, France

family: Sacco

full_name: Emmanuelle Sacco

given: Emmanuelle

family: Fels

full_name: Audrey Fels

given: Audrey

family: Beaussier

full_name: Hélène Beaussier

given: Hélène

name: AURA Saint-Ouen Dialyse, Saint-Ouen, France

family: Ureña-Torres

full_name: Pablo Ureña-Torres

given: Pablo

name: CIC 1418, Hôpital Européen Georges Pompidou Paris, Paris, France

name: Université de Paris Descartes, Paris, France

family: Chatellier

full_name: Gilles Chatellier

given: Gilles

family: Ridel

full_name: Christophe Ridel

given: Christophe

family: Zuber

full_name: Mathieu Zuber

given: Mathieu

journal_name: Nephrology Dialysis Transplantation

oa_colors: green hybrid

oa_host_type: publisher;repository

evidence: open (via crossref license)

host_type: publisher

license: cc-by-nc

license_normalized: cc-by-nc

version: publishedVersion

evidence: oa repository (via pmcid lookup)

host_type: repository

license_normalized: no license

repository_normalized: PubMed Central

lead_sponsor: Groupe Hospitalier Paris Saint Joseph

intervention_type: Diagnostic Test


title: Community Champions Included in the SPICES Project: Study of Facilitators and Barriers to Their Participation in Support Groups for the Primary Prevention of Cardiovascular Risk Factors: A Qualitative Study in Grounded Theory by Semi-structured Interviews and Focus Groups

summary:
In 2017, cardiovascular diseases (CVDs) were the leading cause of death worldwide. Most cardiovascular diseases can be prevented by changing risk behaviors.

CVDs are distributed within a population along a socio-economic gradient. This is true within a country, but also between countries with different income levels. People living in a high-income country have better CVD health status than those living in a low-income country.

Several studies have shown that community-based primary prevention of cardiovascular disease can be effective. Other studies have shown that champions positively influence the implementation of health promotion strategies at the community level. These champions are people in the community who contribute to the implementation of new health programs by involving their local networks.

The SPICES project (Scaling-up Packages of Intervention for Cardiovascular disease prevention in selected sites in Europe and Sub-Saharan Africa) is an international study that aims to implement and evaluate a community-based cardiovascular disease prevention and control program. It involves 5 low, middle and high income countries, including populations in urban, semi-rural and rural areas. The study focused on four sets of interventions: health promotion, cardiovascular risk profiling, management and self-management and follow-up.

In France, the territory of Central West Brittany (CWB) was chosen to participate in the SPICES project because of the vulnerability of its population to cardiovascular disease.

It is in this context that a type 1 hybrid study is being set up in the CWB territory as part of the SPICES project.

For the quantitative part of the protocol (NCT03886064), a randomized controlled trial took place simultaneously to evaluate the effectiveness of a behavior change program led by community champions. Resident volunteers were selected based on their non-laboratory Interheart score. Those with a moderate risk were included in the trial. They were then distributed at random to an intervention group and a control group. The control group received minimal counseling. Those in the intervention group were brought together in support groups, with follow-up by champions.

In a type 1 hybrid trial, qualitative data on implementation are gathered.

The qualitative study will seek to better understand the profile of these champions. A qualitative approach using semi-structured interviews and focus groups was used. The objective is to explore the barriers and facilitators to their participation in support groups for the primary prevention of modifiable cardiovascular risk factors.

ipd_sharing_description: All collected data that underlie results in a publication

lead_sponsor: University Hospital, Brest


title: What Are the Factors for Maintaining and Stopping of Accompanying Citizens? Do Personality Traits of Accompanying Citizens Appear to Influence These Factors?

summary:
In 2017, cardiovascular diseases (CVDs) were the leading cause of death worldwide. Most cardiovascular diseases can be prevented by changing risk behaviors.

CVDs are distributed within a population along a socio-economic gradient. This is true within a country, but also between countries with different income levels. People living in a high-income country have better CVD health status than those living in a low-income country.

Several studies have shown that community-based primary prevention of cardiovascular disease can be effective. Other studies have shown that champions positively influence the implementation of health promotion strategies at the community level. These champions are people in the community who contribute to the implementation of new health programs by involving their local networks.

The SPICES project (Scaling-up Packages of Intervention for Cardiovascular disease prevention in selected sites in Europe and Sub-Saharan Africa) is an international study that aims to implement and evaluate a community-based cardiovascular disease prevention and control program. It involves 5 low, middle and high income countries, including populations in urban, semi-rural and rural areas. The study focused on four sets of interventions: health promotion, cardiovascular risk profiling, management and self-management and follow-up.

In France, the territory of Central West Brittany (CWB) was chosen to participate in the SPICES project because of the vulnerability of its population to cardiovascular disease.

It is in this context that a type 1 hybrid study is being set up in the CWB territory as part of the SPICES project.

For the quantitative part of the protocol (NCT03886064), a randomized controlled trial took place simultaneously to evaluate the effectiveness of a behavior change program led by community champions. Resident volunteers were selected based on their non-laboratory Interheart score. Those with a moderate risk were included in the trial. They were then distributed at random to an intervention group and a control group. The control group received minimal counseling. Those in the intervention group were brought together in support groups, with follow-up by champions.

In a type 1 hybrid trial, qualitative data on implementation are gathered.

This qualitative study will seek understand why participants in the SPICES project staying and/or stopping, from the point of view of champions A qualitative approach using semi-structured interviews and focus groups was used. The objective is to explore maintaining and/or stopping participants in the SPICES project, from the point of view of champions


title: Multicenter Randomized Controlled Trial: Evaluation of the Effects of Respiratory Physiotherapy, Placebo-controlled, in Infants With Moderate Acute Bronchiolitis

acronym: Bronkiville

summary:
Bronchiolitis affects 460,000 children in France per year. The French study called "Bronkilib 2" found a positive effect of chest physiotherapy treatment. This study and the work done so far in chest physiotherapy prompt us to recommend respiratory physiotherapy with slow passive expiratory handlings in the treatment of the moderate bronchiolitis of infants. But, further studies are still needed to corroborate these early findings. The Cochrane is recommending new high-level proof studies on passive expiratory techniques to conclude about their benefits.

The aim of this study is to evaluate the effectiveness of the bronchial drainage procedure carried out during chest physiotherapy sessions, during episodes of moderate to acute bronchiolitis in infants aged 3 to 24 months. Currently, the French High Authority for Health recommends performing physiotherapy sessions for the symptomatologic treatment of acute bronchiolitis in infants - in cases where it could be described as moderate - but few studies have demonstrated the efficacy of this treatment.

The study included infants with a first or a second episode of bronchiolitis classified as moderate according to the Wang's Respiratory score. The treated group will receive chest physiotherapy treatment using slow extended and passive expiratory handlings. The control group will not receive physiotherapy treatment. The study will be conducted during 4 days. The clinical symptoms and the general health condition of the infant will be evaluate by questionnaires.

ReferenceCitation: Postiaux G, Louis J, Labasse HC, Gerroldt J, Kotik AC, Lemuhot A, Patte C. Evaluation of an alternative chest physiotherapy method in infants with respiratory syncytial virus bronchiolitis. Respir Care. 2011 Jul;56(7):989-94. doi: 10.4187/respcare.00721. Epub 2011 Feb 22.

ReferenceCitation: Remondini R, Santos AZ, Castro Gd, Prado Cd, Silva Filho LV. Comparative analysis of the effects of two chest physical therapy interventions in patients with bronchiolitis during hospitalization period. Einstein (Sao Paulo). 2014 Oct-Dec;12(4):452-8. doi: 10.1590/S1679-45082014AO3230.

ReferenceCitation: S Gonçalves RA, Feitosa S, de Castro Selestrin C, Valenti VE, de Sousa FH, F Siqueira AA, Petenusso M, de Abreu LC. Evaluation of physiological parameters before and after respiratory physiotherapy in newborns with acute viral bronchiolitis. Int Arch Med. 2014 Jan 8;7(1):3. doi: 10.1186/1755-7682-7-3.

ReferenceCitation: Postiaux G, Zwaenepoel B, Louis J. Chest physical therapy in acute viral bronchiolitis: an updated review. Respir Care. 2013 Sep;58(9):1541-5. doi: 10.4187/respcare.01890. Epub 2013 Jan 3. Review.

ReferenceCitation: Pupin MK, Riccetto AG, Ribeiro JD, Baracat EC. Comparison of the effects that two different respiratory physical therapy techniques have on cardiorespiratory parameters in infants with acute viral bronchiolitis. J Bras Pneumol. 2009 Sep;35(9):860-7. English, Portuguese.

ReferenceCitation: Sánchez Bayle M, Martín Martín R, Cano Fernández J, Martínez Sánchez G, Gómez Martín J, Yep Chullen G, García García MC. [Chest physiotherapy and bronchiolitis in the hospitalised infant. Double-blind clinical trial]. An Pediatr (Barc). 2012 Jul;77(1):5-11. doi: 10.1016/j.anpedi.2011.11.026. Epub 2012 Jan 26. Spanish.

ReferenceCitation: Ralston SL, Lieberthal AS, Meissner HC. Ralston SL, Lieberthal AS, Meissner HC, et al. Clinical Practice Guideline: The Diagnosis, Management, and Prevention of Bronchiolitis. Pediatrics. 2014;134(5):e1474-e1502. Pediatrics. 2015 Oct;136(4):782. doi: 10.1542/peds.2015-2862.

ReferenceCitation: Roqué i Figuls M, Giné-Garriga M, Granados Rugeles C, Perrotta C, Vilaró J. Chest physiotherapy for acute bronchiolitis in paediatric patients between 0 and 24 months old. Cochrane Database Syst Rev. 2016 Feb 1;2:CD004873. doi: 10.1002/14651858.CD004873.pub5. Review.

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ipd_sharing_description: Collected individual participant data

lead_sponsor: Réseau Kinésithérapie Bronchiolite Essonne

location_facility: Maison de Santé Pluri professionnelle Les allées


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ReferenceCitation: Finlay JL, Goldman S, Wong MC, Cairo M, Garvin J, August C, Cohen BH, Stanley P, Zimmerman RA, Bostrom B, Geyer JR, Harris RE, Sanders J, Yates AJ, Boyett JM, Packer RJ. Pilot study of high-dose thiotepa and etoposide with autologous bone marrow rescue in children and young adults with recurrent CNS tumors. The Children's Cancer Group. J Clin Oncol. 1996 Sep;14(9):2495-503.

ReferenceCitation: Entz-Werlé N, Stoetzel C, Berard-Marec P, Kalifa C, Brugiere L, Pacquement H, Schmitt C, Tabone MD, Gentet JC, Quillet R, Oudet P, Lutz P, Babin-Boilletot A, Gaub MP, Perrin-Schmitt F. Frequent genomic abnormalities at TWIST in human pediatric osteosarcomas. Int J Cancer. 2005 Nov 10;117(3):349-55.

ReferenceCitation: Bertolini F, Mancuso P, Shaked Y, Kerbel RS. Molecular and cellular biomarkers for angiogenesis in clinical oncology. Drug Discov Today. 2007 Oct;12(19-20):806-12. Epub 2007 Sep 27. Review.

ReferenceCitation: Oliveira ID, Petrilli AS, Tavela MH, Zago MA, de Toledo SR. TNF-alpha, TNF-beta, IL-6, IL-10, PECAM-1 and the MPO inflammatory gene polymorphisms in osteosarcoma. J Pediatr Hematol Oncol. 2007 May;29(5):293-7.

ReferenceCitation: Nardin A, Lefebvre ML, Labroquère K, Faure O, Abastado JP. Liposomal muramyl tripeptide phosphatidylethanolamine: Targeting and activating macrophages for adjuvant treatment of osteosarcoma. Curr Cancer Drug Targets. 2006 Mar;6(2):123-33. Review.

ReferenceCitation: Entz-Werle N, Schneider A, Kalifa C, Voegeli AC, Tabone MD, Marec-Berard P, Marcellin L, Pacquement H, Terrier P, Boutard P, Meyer N, Gaub MP, Lutz P, Babin A, Oudet P. Genetic alterations in primary osteosarcoma from 54 children and adolescents by targeted allelotyping. Br J Cancer. 2003 Jun 16;88(12):1925-31.

ReferenceCitation: Entz-Werlé N, Marcellin L, Gaub MP, Guerin E, Schneider A, Berard-Marec P, Kalifa C, Brugiere L, Pacquement H, Schmitt C, Tabone MD, Jeanne-Pasquier C, Terrier P, Dijoud F, Oudet P, Lutz P, Babin-Boilletot A. Prognostic significance of allelic imbalance at the c-kit gene locus and c-kit overexpression by immunohistochemistry in pediatric osteosarcomas. J Clin Oncol. 2005 Apr 1;23(10):2248-55.

ReferenceCitation: Freedman LS. Tables of the number of patients required in clinical trials using the logrank test. Stat Med. 1982 Apr-Jun;1(2):121-9.

ReferenceCitation: Schemper M, Smith TL. A note on quantifying follow-up in studies of failure time. Control Clin Trials. 1996 Aug;17(4):343-6.

ReferenceCitation: Rialland F.Treatment and outcome of relapsed osteosarcoma:experience of the societe française des cancers de l'enfant.(in press). 2008. Ref type:in press

ReferenceCitation: Sutow WW, Herson J, Perez C. Survival after metastasis in osteosarcoma. Natl Cancer Inst Monogr. 1981 Apr;(56):227-31.

ReferenceCitation: Gelderblom H, Sydes MR, Morgan RC, Hogendoorn PC, Lewis IJ, Nooij MA, Taminiau AH, and whelan J. Survival after reccurent osteosarcoma: Data from three European Osteosarcoma Intergroup (EOI) randomized controlled trials.J Clin Oncol26.20-5-2008

ReferenceCitation: Leary SE,Billups A, Watkins A, Wu J, Poe D, Neel MN, Rao BN and Daw NC.Survival of pediatric patients after relapsed osteosarcoma:The St.Jude Children's Research Hospital experience.JOclin Oncol 26.20-5-2008

ReferenceCitation: Beron G, Euler A, winkley K.pulmonary metastase from osteogenic sarcoma: Complete resection and effective chemotherapy contributing to improved prognosis.Eur Paediatr Haematol Oncol 1985; 2:77-85

ReferenceCitation: Kaplan EL MP.Nonparametric estimation from incomplete observations.J Am Stat Assoc 1958

lead_sponsor: Centre Leon Berard

acronym: OSII-TTP

location_facility: Centre Léon Bérard - Institut d'Hémato-Oncologie Pediatrique

location_facility: Institut de Cancérologie de l'Ouest - René Gauducheau

title: Efficacy and Tolerance Adjuvant High-Dose Thiotepa With Peripheral Stem Cell Rescue Associated With Conventional Chemotherapy in Children and Adults With Relapsed Osteosarcoma

summary:
Approximately 150 new cases of osteosarcoma are reported each year in France, of which 15 to 20% are metastatic.

Further to the initial standard care, about 45% of the patients relapse within a median duration of 20 months.

Result of the OS94 study results and of the investigation performed within the CRLCC, indicate that 25 to 30 patients (children and adults) experience an osteosarcoma relapse each year in FRANCE.

According to several studies, the 5-year overall survival rate of patients in first relapse is 23-28%,with a median post relapse survival of 10 to 17 months. Multiple relapse cases are also reported in the COSS study, with a median time to second relapse of 0.8 year.

At present, there is no reference treatment for the standard care of osteosarcoma relapse in FRANCE.

Thiotepa is known for its antitumor effect in numerous malignant tumors. In 2007, a study from our institution reported that about 35% of all osteosarcoma relapses are treated with a high-dose thiotepa while the efficacy and tolerance of this therapeutic strategy have never been assessed.

These results highlight the need to the evaluate the efficacy and tolerance of this high-dose of thiotepa within a clinical trial and its inclusion in the standard care of the osteosarcoma at relapse.


title: Interest of the 18F-DOPA-PET Imaging in Metastatic Melanoma Treated With B-RAF Inhibitors: a Pilot Study

summary:
Melanoma incidence is increasing in most developed countries. At the metastatic stage, the prognosis is usually poor. Major advances have been obtained over the last 3 years with the development of therapies targeting the MAP kinases pathway.

Vemurafenib (zelboraf®) is approved in France since 2012 as first treatment of metastatic melanoma carrying a B-RAF mutation.

For growth, the tumor needs an adequate supply of nutrients to allow the synthesis of macromolecules and a contribution in carbon elements to ensure the production of energy. The nutrition demand is met through greater availability of nutrients via tumor angiogenesis and through increased intracellular penetration of nutrients via specific upregulation of transport systems and metabolic pathways.

Scanner is the imaging method most commonly used for the evaluation of therapeutic response. Such a method gives a morphological indication but does not evaluate the metabolic response.

With the development of functional imaging techniques and the advent of positron emission tomography (PET), it is now possible to obtain an assessment of the metabolic activity of tumors. The use of 18F-FDG to assess therapeutic responses to targeted therapies is fairly recent. The advantage of this approach is well documented for GIST and non-small cell lung cancer. In melanoma, the metabolic response to 18F-FDG is much faster than the response to TAP scanner.

18F-FDG tracer that targets glucose metabolism, is the most sensitive functional imaging in melanoma, which has hindered the development of other tracers such as 18F-FDOPA and 18F-FLT. The 18F-FDG TEP can thus be used in the initial staging and follow-up of the disease, a situation in which it can replace the TAP scanner, additional brain imaging remaining necessary.

The use of metabolic imaging to study the response to targeted therapies in melanoma has been the subject of only one publications. There was a trend toward improved progression-free survival in patients with high metabolic response at day J15.

For melanoma, the diagnostic sensitivity of PET 18F-FDOPA is lower than that of 18F-FDG (64% versus 95%). In contrast, the 18F-FDOPA tracer has the advantage of allowing a brain assessment, which is critical in melanoma that gives frequent metastases in the central nervous system. There has never been any evaluation of the metabolic response to targeted therapies such as BRAF inhibitors PET with 18F-FDOPA.

The investigators propose to conduct a monocentric prospective preliminary study to explore the potential usefulness of the metabolic PET imaging with 18F-FDOPA in the evaluation of metabolic response of B-RAF mutated metastatic melanoma treated with vemurafenib.


title: Cohort for Research and Innovation in Chronic Inflammatory Respiratory Diseases: The RINNOPARI Project

acronym: RINNOPARI

summary:
Chronic inflammatory pulmonary diseases including chronic obstructive pulmonary disease (COPD), interstitial lung diseases (ILD), bronchiectasis, and cystic fibrosis (CF) are characterized by lung inflammation and remodelling. Clinical, functional, microbiological, biological, pathological and prognosis features are highly variable and heterogeneous. A precise phenotyping is a key-element to better understanding the pathophysiology of these chronic inflammatory diseases and to develop innovative treatment strategies.

The objectives of this prospective study is to analyze the clinical, demographic, biological, morphological, pathological, and microbiological characteristics in a cohort of patients diagnosed with COPD, ILD, bronchiectasis, and CF. The associations between clinical, demographic, biological, morphological, pathological, and microbiological features will be assessed.

The Cohort for Research and Innovation in Chronic Inflammatory Respiratory Diseases (the RINNOPARI Project: Recherche et Innovation en Pathologie Respiratoire Inflammatoire) is a monocentric study conducted at the University Hospital of Reims, France. Adult patients (>18 year-old) followed at the University Hospital of Reims and diagnosed with COPD, ILD, bronchiectasis, or CF will be considered for inclusion. Patients will sign an informed consent for inclusion. Exclusion criteria include "subjects protected by the law" as required by the French authorities. Control patients with no respiratory diseases after clinical and pulmonary function tests assessment will be also included. The expected number of patients included is 225 (COPD, n=100; CF, n=25; bronchiectasis, n=25; ILD, n=25; controls, n=50). Inclusion will be conducted for 36 months from September 2016 (9/30/2016) to September 2019 (9/30/2019).

For all COPD, ILD, bronchiectasis, and CF patients included, data will be registered at inclusion, and at follow-up visits for 10 years. Patients will be followed-up as usual care with no specific therapeutic intervention. For control patients, data will be registered at inclusion with no follow-up.

Data will be registered in a centralized anonymized database. The characteristics of the patients will be described as mean and standard deviation for quantitative data and as number and percentages for qualitative data. Comparisons and associations between groups and variables will be analyzed by Student, Wilcoxon, Chi2, Fischer exact, and Spearman tests as applicable. A p<0.05 will be considered as significant.

This study should help to better characterize clinical, demographic, biological, morphological, pathological, and microbiological characteristics and phenotypes in chronic inflammatory respiratory diseases.

ReferenceCitation: Dury S, Perotin JM, Ravoninjatovo B, Llerena C, Ancel J, Mulette P, Griffon M, Carré S, Perrin A, Lebargy F, Deslée G, Launois C. Identifying specific needs in adult cystic fibrosis patients: a pilot study using a custom questionnaire. BMC Pulm Med. 2021 Aug 18;21(1):270. doi: 10.1186/s12890-021-01613-4.

family: Dury

full_name: Sandra Dury

given: Sandra

family: Perotin

full_name: Jeanne-Marie Perotin

given: Jeanne-Marie

family: Ravoninjatovo

full_name: Bruno Ravoninjatovo

given: Bruno

family: Llerena

full_name: Catherine Llerena

family: Ancel

full_name: Julien Ancel

given: Julien

family: Mulette

full_name: Pauline Mulette

family: Griffon

full_name: Muriel Griffon

given: Muriel

family: Carré

full_name: Sophie Carré

given: Sophie

family: Perrin

full_name: Amélie Perrin

given: Amélie

family: Lebargy

full_name: François Lebargy

given: François

family: Deslée

full_name: Gaëtan Deslée

given: Gaëtan

family: Launois

full_name: Claire Launois

currency_apc_doaj: GBP

journal_name: BMC Pulmonary Medicine

oa_colors: green gold

evidence: oa journal (via doaj)

license: cc-by

license_normalized: cc-by

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

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

repository_normalized: HAL

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

repositories:
HAL
PubMed Central

publisher: Springer Science and Business Media LLC

publisher_dissemination: Springer-Nature

publisher_group: Springer-Nature

publisher_normalized: Springer

ReferenceCitation: Mulette P, Ravoninjatovo B, Guguen C, Barbe C, Ancel J, Dury S, Dumazet A, Perdu D, Perotin JM, Guillard T, Lebargy F, Deslee G, Launois C. Insomnia in adults with cystic fibrosis: strong association with anxiety/depression and impaired quality of life. BMC Pulm Med. 2021 Apr 1;21(1):108. doi: 10.1186/s12890-021-01473-y.

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


title: Longitudinal and Comparative Study of Morphological Abnormalities of the Olfactory Bulb on MRI and Olfactometry in Anosmic Versus Normosmic COVID-19 Patients

summary: Olfactory and gustatory disorders are prevalent symptoms in European COVID-19 patients. This study aimed to detect these disturbances among positive COVID-19 patients (symptom not initially highlighted by the patient and not sought by caregivers) in order to allow early management of olfactory and gustatory dysfunction.

primary_purpose: Diagnostic

ReferenceCitation: Lechien JR, Chiesa-Estomba CM, De Siati DR, Horoi M, Le Bon SD, Rodriguez A, Dequanter D, Blecic S, El Afia F, Distinguin L, Chekkoury-Idrissi Y, Hans S, Delgado IL, Calvo-Henriquez C, Lavigne P, Falanga C, Barillari MR, Cammaroto G, Khalife M, Leich P, Souchay C, Rossi C, Journe F, Hsieh J, Edjlali M, Carlier R, Ris L, Lovato A, De Filippis C, Coppee F, Fakhry N, Ayad T, Saussez S. Olfactory and gustatory dysfunctions as a clinical presentation of mild-to-moderate forms of the coronavirus disease (COVID-19): a multicenter European study. Eur Arch Otorhinolaryngol. 2020 Aug;277(8):2251-2261. doi: 10.1007/s00405-020-05965-1. Epub 2020 Apr 6.

location_facility:
Hopital Raymond Poincare
Hopital Foch


title: Efficacy of an Intranasal Stent on Nasal Obstruction at Night: A Prospective Multicenter Study

acronym: RHINASTENT

summary: This study aims to demonstrate a decrease with normalization of nasal resistance in the forward decubital position and with an intra-nasal stent in patients with nasal obstruction.

lead_sponsor: Centre Hospitalier Intercommunal Creteil

location_facility:
Hôpital Henri Mondor
Centre Hospitalier Intercommunal


title: Preoperative Psychological Risk Factors for the Retractable Capsulitis of the Shoulder After Shoulder Rotator Cuff Repair Surgery

summary: The main objective of our study is to determine whether preoperative anxiety, depression and kinesiophobia are risk factors for retractile capsulitis after arthroscopic rotator cuff repair to best support these patients. patients postoperatively.

lead_sponsor: Hospital Ambroise Paré Paris

location_facility: Groupe Hospitalier Diaconesses Croix Saint-Simon

intervention_type: Procedure


title: Learning Process of 5th Year Medical Students During Simulation Training in Psychiatry: a Multicentric Mixed Method Study

acronym: APSIMP

summary:
In french context, simulation training is not well implemented in medical school, mainly in psychiatry. We aim to build a formative and summative assessment tool of competences specific to this pedagogic context, so as to support its development.

This studies aims to explore learning process and factors supporting or preventing from learning of medical students during simulation in psychiatry.

A convenient sample of 72 voluntary participants, allocated among 6 groups of around 12 students, will be recruited at Paris Descartes, Paris Diderot and Brest Universities between september of 2018 and june of 2019. Each participant will complete 6 hours of psychiatric simulation training, dealing with mood disorders, anxious disorders, eating disorders, borderline disorders, substance abuse and schizophrenia.

Participant will be offered to complete a portfolio about learning process during the trimester they are involved, a concept gap before and after each training and the " Learning Effectiveness Inventory Scale "at the end of simulation. A purposive sample of students will have to complete a face-to-face semi-interview (until reaching data saturation).

Video record of simulation and audio-record of debriefing will be analysed to enhance triangulation process of analysis.

ReferenceCitation: Lavoie P, Michaud C, Bélisle M, Boyer L, Gosselin É, Grondin M, Larue C, Lavoie S, Pepin J. Learning theories and tools for the assessment of core nursing competencies in simulation: A theoretical review. J Adv Nurs. 2018 Feb;74(2):239-250. doi: 10.1111/jan.13416. Epub 2017 Sep 20. Review.

ReferenceCitation: Bandura A. Self-efficacy: toward a unifying theory of behavioral change. Psychol Rev. 1977 Mar;84(2):191-215.

ReferenceCitation: Chen SL, Huang TW, Liao IC, Liu C. Development and validation of the Simulation Learning Effectiveness Inventory. J Adv Nurs. 2015 Oct;71(10):2444-53. doi: 10.1111/jan.12707. Epub 2015 Jun 15.

lead_sponsor: Institut Mutualiste Montsouris

location_facility:
Institut mutualiste montsouris
Institut Mutualiste Montsouris


title: Randomised Controlled Trial to Evaluate the Benefit of Traditional Karate in Heart Failure During Cardiac Rehabilitation

acronym: KAREAD

summary:
Cardiac rehabilitation is based on physical activity which, usually, associates combination of a cycle ergometer or treadmill completed by gymnastics.

Some studies have been done with complementary physical activities such as tai chi or yoga integrated into the strategy of non-drug therapies. The tai chi study showed a tendency to improve the peak of VO2 in the tai chi group but which was not significant but also a significant improvement on secondary objectives such as quality of life, the increase in the 6-minute walk test and a decrease in the level of natriuretic peptides. A study of the effects of yoga after coronary artery bypass surgery showed at one year an improvement of the ejection fraction, the lipid profile and the state of anxiety of the patients. This study showed that the addition of yoga to conventional cardiac rehabilitation could improve cardiovascular risk factors especially in patients with abnormalities such as low HDL.

The physical activities offered in rehabilitation to improve physical performance are currently limited to cycling, treadmill or gymnastics. Many patients do not like cycling or treadmill, which limits their adherence to a cardiac rehabilitation program. Moreover, one of the main problems of rehabilitation is that after the rehabilitation cycle, a minority of patients continue the physical activity. Strategies for implementing home exercises have been tested to increase the level of physical activity after rehabilitation.

Cardiac rehabilitation has several components: correction of risk factors, optimization of treatment, physical activity to improve the physical abilities to exertion that are directly correlated to mortality.

Our hypothesis is that the implementation of a program of physical activity based on traditional karate would improve the physical abilities to effort and the quality of life of patients, to give a better psychological confidence to patients who, after a cardiovascular event such as acute coronary syndrome, bypass surgery or valvular surgery, have marked anxiety or depression. Rehabilitation, and especially physical activity, is one of the therapeutic means proposed. The interest of this study would be to be able to offer an additional activity for rehabilitation centers, to offer patients an activity in post-rehabilitation. In addition, interaction between patients could increase adherence to rehabilitation.

location_facility:
Groupe Hospitalier Paris Saint-Joseph
Hôpital Corentin Celton


title: Study of Psychomotor Development and Attachment in Children Aged 6 to 30 Months With Oral Disorder

acronym: TODEVA

summary: Dietary difficulties and eating disorders of the child are a common reason for consulting infants and young children. There is currently little data on the psychomotor development of these children and their association with parent-child attachment. The objective of this study is to evaluate, at the same time, the three physiological, psychomotor and attachment dimensions of children with eating disorders.

status: Terminated

ReferenceCitation: Ammaniti M, Lucarelli L, Cimino S, D'Olimpio F, Chatoor I. Feeding disorders of infancy: a longitudinal study to middle childhood. Int J Eat Disord. 2012 Mar;45(2):272-80. doi: 10.1002/eat.20925. Epub 2011 Apr 14.

ReferenceCitation: Cardona Cano S, Tiemeier H, Van Hoeken D, Tharner A, Jaddoe VW, Hofman A, Verhulst FC, Hoek HW. Trajectories of picky eating during childhood: A general population study. Int J Eat Disord. 2015 Sep;48(6):570-9. doi: 10.1002/eat.22384. Epub 2015 Jan 30.

ReferenceCitation: Dubedout S, Cascales T, Mas E, Bion A, Vignes M, Raynaud JP, Olives JP. [Feeding disorders in infants and toddlers: At-risk situations and predisposing factors]. Arch Pediatr. 2016 Jun;23(6):570-6. doi: 10.1016/j.arcped.2016.03.015. Epub 2016 Apr 25. French.

ReferenceCitation: Kerzner B, Milano K, MacLean WC Jr, Berall G, Stuart S, Chatoor I. A practical approach to classifying and managing feeding difficulties. Pediatrics. 2015 Feb;135(2):344-53. doi: 10.1542/peds.2014-1630. Epub 2015 Jan 5. Review.

ReferenceCitation: Le Heuzey MF. [Child food refusal: when will we call a child psychiatrist?]. Arch Pediatr. 2011 Aug;18(8):917-20. doi: 10.1016/j.arcped.2011.05.014. Epub 2011 Jun 16. French.

ReferenceCitation: Issanchou S, Nicklaus S. [Early determinants of food behaviour]. Arch Pediatr. 2010 Jun;17(6):713-4. doi: 10.1016/S0929-693X(10)70073-7. French.

ReferenceCitation: Quah PL, Chan YH, Aris IM, Pang WW, Toh JY, Tint MT, Broekman BF, Saw SM, Kwek K, Godfrey KM, Gluckman PD, Chong YS, Meaney MJ, Yap FK, van Dam RM, Lee YS, Chong MF; GUSTO Study Group. Prospective associations of appetitive traits at 3 and 12 months of age with body mass index and weight gain in the first 2 years of life. BMC Pediatr. 2015 Oct 12;15:153. doi: 10.1186/s12887-015-0467-8.

lead_sponsor: Camille JUNG

location_facility:
CHI Créteil
CHI Creteil


title: Development and Validation of a Predictive Score for the Ischemic Etiology of a Transient Diplopia

acronym: VASCO-DIP

summary:
The transient diplopias (TD) is defined by a short diplopia. Their etiology may be ophthalmological, neurological non-ischemic or of ischemic origin.

The difficulty is to recognize an ischemic mechanism which imposes emergency cares.

A clinical score could help the clinician to recognize the etiology of the TD .

lead_sponsor: Fondation Ophtalmologique Adolphe de Rothschild


title: Cancer and Sexual Health : Early Information and Sexual Satisfaction of Couples in Oncology

acronym: COUPLE

summary:
In a perspective of improvement of the global care of the patients, investigators wish to estimate, within the oncology department of Paris Saint Joseph Hospital, the impact of a clear, written and oral information, on the sexual satisfaction of the couples during treatments.

Further to this study, the project will be to train and to sensitize the medical staff, or still to develop new activities to meet the needs better of patients and of partners.

location_facility:
hopital Saint Joseph
Groupe Hospitalier Paris Saint Joseph

intervention_type: Behavioral


title: Performance Assessment of High Throughput Sequencing for the Detection of Pathogens in Immunocompromised Patients With Suspected Infectious Disease.

summary:
The study patients are patients suffering from primary or secondary immunodeficiencies investigated in the Hospital Necker for a suspected infectious disease.

The study purpose is to assess the performance of a High Throughput Sequencing method, the PATHOQUEST method (from sample preparation to bio informatic analysis), versus the classic diagnostic approach.

The study will evaluate the capacity of the PATHOQUEST method to detect pathogens responsible for an infectious disease episode and will also evaluate the delay of obtention of results compared to the classic diagnostic approach.

lead_sponsor: Pathoquest

location_facility:
Hôpital Européen Georges Pompidou
Hopital Necker - Enfants malades


title: Relationship Between Blood, Hair and Lung Metals/Metalloids Concentration (Cadmium, Iron, Copper, Nickel, Chrome, Arsenic, Vanadium, Beryllium, and Zinc) and Lung Cancer or Chronic Obstructive Pulmonary Disease.

acronym: Métaux/Poumons

summary: Prospective research to study the relationship between concentrations of metals/metalloids in blood, hair and lung tissue with the occurence of lung cancer or chronic obstructive pulmonary disease.

location_facility: CHU de Poitiers, Chirurgie Cardiaque et Thoracique


title: Prediction of the Occurrence of Chronic Pain After Thoracotomy by Measuring Preoperative Skin Conductance (Pain Monitor Device)

summary:
The skin conductance algesimeter (Pain Monitor™, Med-Storm Innovation AS, NO-0264 Oslo, Norway)) reflects the sympathetic nervous system by the measurement of the skin conductance of the palm of the hand. SCA detects nociceptive pain fast and continuously, specific to the individual, with higher sensitivity and specificity than other available objective methods.

The skin conductance response to a calibrated noxious stimulus varies among patients. It defines two types of people depending on its magnitude.

The investigators assume that the importance of skin conductance response to a noxious stimulus predicts the occurrence of chronic pain in patients operated by thoracotomy.

ReferenceCitation: Storm H. Changes in skin conductance as a tool to monitor nociceptive stimulation and pain. Curr Opin Anaesthesiol. 2008 Dec;21(6):796-804. doi: 10.1097/ACO.0b013e3283183fe4. Review.

location_facility:
CHU Strasbourg
Hopital Foch


title: Dose-effect of Propofol for Anesthetic Induction: Double-blind Comparison of Different Propofol Formulations Administered Alone or With Remifentanil

acronym: PropofolRemi

summary: The objective of this study is to evaluate the influence of different propofol formulations (plain or with remifentanil) on anesthetic induction. Propofol plain or with remifentanil is administered using a closed-loop algorithm in order to reach a Bispectral Index target of 50.

location_facility:
Hopital Foch
CHU Besançon


title: Evaluation of the Relapse Rate One Month After Discharge From Emergency Department for Asthmatic Patients Given a Strict Formalized Follow up Protocol. Multicenter, Prospective, Cluster-randomized

acronym: ASUR-R

summary:
For over ten years, the French group ASUR (ASthme aux URgences) has studied the asthmatic disease. The first epidemiological study enrolling 3.772 patients, in 37 emergency services, showed that the treatment protocols during the acute asthma attacks were not homogeneous and that oral corticosteroids were prescribed in only 50% of the cases. The second major French study in the emergency department by the same group enrolled 3.049 patients. The results showed that 38% of patients have a new acute asthma relapse in the month following their consultation in the emergency department. In the same study, a multivariate analysis of predictors of relapse showed that there are controllable factors (absence of written recommendations at discharge, only 50% of prescriptions for oral corticosteroids at discharge from the emergency department, limited follow-up by a general practitioner (GP) or pneumologist ...).

The emergency physician has a responsibility in educating the patient during the period between an acute asthma attack and return to the stability of long term therapy. To date, the impact of patient education on the rate of further consultations in the emergency department has not been proven, although it seems to be a positive trend on its effect. In France, half of the patients coming to the emergency department for asthma attack will not be hospitalized. More than a third will return to the ED within the first 30 days for a new attack. The impact of post-interventional education on relapse should be explored. A first major study on a strict formalized protocol designed to reduce the relapse rate is essential and could allow a major improvement.

Our main objective is to assess the impact of a strict formalized protocol of care of asthmatic patients discharged from the Emergency Department on the recurrence rate of asthma attacks, one month after an asthma attack.

The expected benefit for the patient is the short-term reduction of relapse after asthma exacerbations, thus avoiding the problems of readmission. The strict formalized discharge protocol would also improve education in terms of self-medication in this gray zone of post-therapeutic monitoring. The benefit is even more important in terms of public health due to the important prevalence of asthma in the world and in our country. The advantage of this protocol is to strengthen the links between the hospital and the GPs. Education of asthmatic patients is essential in reducing morbidity. Thus, the potential benefits of this protocol are: reducing the cost of health and re-hospitalization, improved education of asthma patients, strengthening their link with the required GP, decreased absenteeism usually frequent in this type of disease in the workplace.

lead_sponsor: Assistance Publique - Hôpitaux de Paris

location_facility: Service des Urgences, Hôpital Lariboisière


title: Fibrin Glue for Perianal Fistulas in Crohn's Disease: a Randomized Controlled Trial

acronym: Fibrin glue

summary: This multicenter, randomized, controlled trial was conducted by the Groupe d'Etude Thérapeutique des Affections Inflammatoires du tube Digestif (GETAID) to evaluate the efficacy and safety of the injection of fibrin glue in perianal fistulas tracts of patients with CD. The institutional Independent Ethics Committee of Marseille, France and of Liège, Belgium approved the protocol for each participating centers. Recruitment took place at 12 sites (11 in France and 1 in Belgium)

ReferenceCitation: Hellers G, Bergstrand O, Ewerth S, Holmström B. Occurrence and outcome after primary treatment of anal fistulae in Crohn's disease. Gut. 1980 Jun;21(6):525-7.

ReferenceCitation: Schwartz DA, Loftus EV Jr, Tremaine WJ, Panaccione R, Harmsen WS, Zinsmeister AR, Sandborn WJ. The natural history of fistulizing Crohn's disease in Olmsted County, Minnesota. Gastroenterology. 2002 Apr;122(4):875-80.

ReferenceCitation: Schwartz DA, Pemberton JH, Sandborn WJ. Diagnosis and treatment of perianal fistulas in Crohn disease. Ann Intern Med. 2001 Nov 20;135(10):906-18. Review.

ReferenceCitation: Bernstein LH, Frank MS, Brandt LJ, Boley SJ. Healing of perineal Crohn's disease with metronidazole. Gastroenterology. 1980 Aug;79(2):357-65.

ReferenceCitation: Present DH, Korelitz BI, Wisch N, Glass JL, Sachar DB, Pasternack BS. Treatment of Crohn's disease with 6-mercaptopurine. A long-term, randomized, double-blind study. N Engl J Med. 1980 May 1;302(18):981-7.

ReferenceCitation: Pearson DC, May GR, Fick GH, Sutherland LR. Azathioprine and 6-mercaptopurine in Crohn disease. A meta-analysis. Ann Intern Med. 1995 Jul 15;123(2):132-42.

ReferenceCitation: Grimaud JC, Munoz-Bongrand N, Siproudhis L, Abramowitz L, Sénéjoux A, Vitton V, Gambiez L, Flourié B, Hébuterne X, Louis E, Coffin B, De Parades V, Savoye G, Soulé JC, Bouhnik Y, Colombel JF, Contou JF, François Y, Mary JY, Lémann M; Groupe d'Etude Thérapeutique des Affections Inflammatoires du Tube Digestif. Fibrin glue is effective healing perianal fistulas in patients with Crohn's disease. Gastroenterology. 2010 Jun;138(7):2275-81, 2281.e1. doi: 10.1053/j.gastro.2010.02.013. Epub 2010 Feb 20.

family: Grimaud

full_name: Jean–Charles Grimaud

given: Jean–Charles

family: Munoz–Bongrand

full_name: Nicolas Munoz–Bongrand

given: Nicolas

family: Siproudhis

full_name: Laurent Siproudhis

given: Laurent

family: Abramowitz

full_name: Laurent Abramowitz

family: Sénéjoux

full_name: Agnès Sénéjoux

given: Agnès

family: Vitton

full_name: Véronique Vitton

given: Véronique

family: Gambiez

full_name: Luc Gambiez

given: Luc

family: Flourié

full_name: Bernard Flourié

given: Bernard

family: Hébuterne

full_name: Xavier Hébuterne

given: Xavier

family: Louis

full_name: Edouard Louis

given: Edouard

family: Coffin

full_name: Benoit Coffin

given: Benoit

family: De Parades

full_name: Vincent De Parades

given: Vincent

family: Savoye

full_name: Guillaume Savoye

given: Guillaume

family: Soulé

full_name: Jean–Claude Soulé

given: Jean–Claude

family: Bouhnik

full_name: Yoram Bouhnik

given: Yoram

family: Colombel

full_name: Jean–Frédéric Colombel

given: Jean–Frédéric

family: Contou

full_name: Jean–François Contou

given: Jean–François

family: François

full_name: Yves François

given: Yves

family: Mary

full_name: Jean–Yves Mary

given: Jean–Yves

family: Lémann

full_name: Marc Lémann

given: Marc

journal_name: Gastroenterology

title: Fibrin Glue Is Effective Healing Perianal Fistulas in Patients with Crohn's Disease

lead_sponsor: Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives

location_facility:
CHRU Lille
Louis Mourrier Hospital
Sart Tilman University Hospital
Georges Pompidou European Hospital
Lariboisiere Hospital
Beaujon Hospital
Nice University Hospital
Lyon Sud University Hospital
Rouen University Hospital
Marseille North Hospital
Hopital St Louis
Trousseau University Hospital
Bichat Hospital
Pontchaillou University Hospital