title: Fertility After Myomectomy Versus Uterine Artery Embolization for Symptomatic Uterine Fibroids

summary:
Purpose of this study:

To establish the superiority of myomectomy versus Uterine Artery Embolization, in women with multiple symptomatic fibroids and no other infertility factor, seeking to conceive.

ReferenceCitation: Gupta JK, Sinha A, Lumsden MA, Hickey M. Uterine artery embolization for symptomatic uterine fibroids. Cochrane Database Syst Rev. 2012 May 16;(5):CD005073. doi: 10.1002/14651858.CD005073.pub3.

ReferenceCitation: Torre A, Paillusson B, Fain V, Labauge P, Pelage JP, Fauconnier A. Uterine artery embolization for severe symptomatic fibroids: effects on fertility and symptoms. Hum Reprod. 2014 Mar;29(3):490-501. doi: 10.1093/humrep/det459. Epub 2014 Jan 15.

ReferenceCitation: Mara M, Maskova J, Fucikova Z, Kuzel D, Belsan T, Sosna O. Midterm clinical and first reproductive results of a randomized controlled trial comparing uterine fibroid embolization and myomectomy. Cardiovasc Intervent Radiol. 2008 Jan-Feb;31(1):73-85. doi: 10.1007/s00270-007-9195-2. Epub 2007 Oct 18.

location_facility: Département de Médecine de la Reproduction, Centre Hospitalier Régionnal Universitaire de Montpellier

appel_a_projets: PHRCI

region: Île-de-France

nom_etablissement: ASSISTANCE PUBLIQUE-HOPITAUX DE PARIS

type_etablissement: CHUR

acronyme: EMBOFERTIL

titre: Fertilité après Poly-myomectomie versus Embolisation des artères utérines pour fibromes utérins symptomatiques: essai randomisé multicentrique interventionnel ouvert, en intention de traiter.

discipline_principale: autre

nom_porteur: TORRE

prenom_porteur: Antoine


title: Using a TENS System (Transcutaneous Electrical Noninvasive Stimulation) to Improve Pain Related to Fibromyalgia (EXOFIB)

acronym: EXOFIB

summary:
Fibromyalgia is a debilitating pain condition that is characterized by the chronic occurrence of pain affecting the musculoskeletal system, a sensitivity to pressure stimuli, and a low threshold to noxious stimuli. The topography of pain is widespread, although it could be more pronounced in some bodily regions. Besides pain, patients suffer from a wide range of symptoms, including fatigue, anxiety and depression manifestations, and altered quality of life. Facing these debilitating symptoms, the available therapeutic strategies for treating pain and associated manifestations are usually faced with limited efficacy and numerous side effects. For these reasons, non-invasive stimulation techniques, namely transcutaneous stimulation by means of Exopulse Mollii suit, might be of help in this context.

The investigators designed a randomized sham controlled double-blind trial to demonstrate the improvement of pain, quality of life, fatigue and mood in adult patients with fibromyalgia following a 2-week intervention of "active" versus "sham" Exopulse Mollii suit. A 2-week washout period should be enough to prevent a potential carry over effect. After this phase (phase 1), a second open label phase (phase 2) will be proposed for patients to understand the effects of Exopulse Mollii suit employed for 4 weeks (7 sessions per week) on the studied outcomes.

study_start_date_type: Actual

status: Completed

study_completion_date_type: Actual

study_type: Interventional

design_allocation: Randomized

primary_purpose: Treatment

enrollment_type: Actual

ipd_sharing: No

lead_sponsor: Institut De La Colonne Vertebrale Et Des Neurosciences

intervention_type: Device

lead_sponsor_type: industriel

status_simplified: Completed


title: Observational Study on CML Patients in Any Phase of the Disease Treated With Ponatinib (Iclusig®): A Multicentre, Ambispective Cohort Study

summary: This is a multicentre ambispective cohort study involving French patients who have started or are receiving for less than 6 months a treatment with ponatinib. This study aims at better qualifying the ponatinib benefit-risk balance in real life and in relation with CML patients' therapeutic history.

study_type: Observational

time_perspective: Other

lead_sponsor: Incyte BioSciences France

location_facility: Cabinet D'hematologie De La Clinique Du Parc

location_facility: CH De Metz (Hopital De Mercy - CHR Metz Thionville)

location_facility: Institut Universitaire Du Cancer Toulouse - Oncopo

location_facility: Hopitaux Prives Metz Centre De Belle-Isle


title: Art'Health: Effects of Artistic and Participative Workshops at the MAMAC of Nice on the Health of Seniors

acronym: Art'Health

summary: Study with two arms, one of which receives an intervention in the form of participative artistic workshops at the MAMAC and the other was assigned as the control group. Well-being, Quality of life, Health, Apathy and Olfactory identification scales are proposed before the intervention, during the intervention at the end of each month (M1, M2, M3), 6 months after the end of the intervention (M9) and 12 months after the end of the intervention (M15).

primary_purpose: Other

ipd_sharing: Undecided

lead_sponsor: Centre Hospitalier Universitaire de Nice

location_facility: Centre Mémoire de Ressources et de Recherche, CHU de Nice

intervention_type: Other

lead_sponsor_type: academique


acronym: MAPAGE

summary:
High blood pressure (HBP) is a major modifiable cardiovascular risk factor which prevalence is gradually increasing. Reducing blood pressure (BP) significantly decreases cardiovascular morbi-mortality. Nevertheless, BP control remains insufficient: only 51% of French patients using antihypertensive drugs achieve the BP control targets.

HBP is mostly diagnosed and managed in primary care. Nevertheless, office BP measurements are unreliable for BP control and poorer predict target organ damage. Ambulatory BP measurements are recommended for HBP diagnosis and follow-up. 24-hour ambulatory blood pressure monitoring (ABPM) is the most cost-effective strategy. Its superiority has been demonstrated for HBP diagnosis and cardiovascular prognosis.

In France, ABPM is poorly available and little studied in primary care. Therefore, the investigators conducted a regional prospective study to analyze the feasibility and benefits of ABPM among primary care hypertensive patients in daily practice.

status: Unknown status

study_completion_date_type: Anticipated

time_perspective: Prospective

enrollment_type: Anticipated

lead_sponsor: University of Burgundy

collaborators: Association pour le Développement de la Recherche en Médecine Générale (ADRMG)

collaborators: Département de Médecine Générale de Dijon (DMG)

location_facility: Groupement des Professionnels de Santé de l'Auxois Sud

location_facility: Maison Universitaire de Santé et de Soins Primaires

location_facility: Groupements des Professionnels de Santé du Pays Beaunois

status_simplified: Unknown


title: Modelling Interface Pressure Applied by Superimposed Compression Bandages

summary: The aim of the study is to measure and model interface pressure applied on the lower leg of patients at risk of veinous thrombosis, by different bandage combinations, composed of Biflex 16 (Thuasne) and/or Rosidal K (Lohmann & Rauscher). The patient specific model should better predict the interface pressure distribution than Laplace's Law.

primary_purpose: Basic Science

ReferenceType: derived

ReferenceCitation: Chassagne F, Helouin-Desenne C, Molimard J, Convert R, Badel P, Giraux P. Superimposition of elastic and nonelastic compression bandages. J Vasc Surg Venous Lymphat Disord. 2017 Nov;5(6):851-858. doi: 10.1016/j.jvsv.2017.07.006.

oa_host_type: repository

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

host_type: repository

license_normalized: no license

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

repository_normalized: HAL

version: submittedVersion

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

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

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

repositories_concat: HAL

unpaywall_oa_status: green

publisher_dissemination: Elsevier

lead_sponsor: Thuasne

location_facility: Service de Médecine Physique et de Réadaptation, CHU Bellevue


type: EudraCT Number

title: Study of the Efficacy and Tolerance of Oral Treatment of Lcr Restituo® Sachets (Lactobacillus Rhamnosus Lcr35®) on Intolerance to Metformin (Diarrhoea) in Patients With Diabetes Type 2

acronym: PROVAME

summary:
The mechanisms of diarrhoea under metformin are poorly known. Recent data indicate that a change in gut flora might be responsible for this intestinal disorder. The effect of metformin on the gut flora has been extensively described. It has been shown that the therapeutic effect of metformin depends on the microbiota. In agreement with these data, a recent publication has shown that metformin's main site of action in humans was the intestine. In light of these results, it now seems plausible that metformin's effect on the gut flora is responsible not only for its therapeutic effect but also for its undesirable digestive effects. In this respect, Lactobacillus rhamnosus has shown anti-diarrhoeal effects (approximately 50% reduction in diarrhoeas) in the contexts of infection-caused dysbiosis and post-antibiotic dysbiosis.

Hypothesis: Taking into account the favourable effect on intestinal dysbiosis-induced diarrhoeas observed with Lactobacillus rhamnosus, we put forward the hypothesis that Lactobacillus rhamnosus Lcr35® will have a favourable effect on metformin-induced diarrhoea.

primary_purpose: Prevention

lead_sponsor: Biose

intervention_type: Drug


title: Intraoperative Indocyanine Green Fluorescence Angiography in Colorectal Surgery to Prevent Anastomotic Leakage: a Single-blind Phase III Multicenter Randomized Controlled Trial (Intergroup FRENCH-GRECCAR Trial)

summary:
Colorectal cancer (CRC) is the fourth most commonly diagnosed cancer in the world and the third in France. Its incidence is steadily rising in developing nations. Anastomotic leak (AL) is a major problem in colorectal surgery affecting at least 7% of patients operated on for left colonic cancer. It is the most feared complication after colorectal anastomosis, associated with mortality, prolonged hospitalization, impaired health related quality of life (HRQoL) and increased health care costs. Intraoperative fluorescence angiography (IOFA) with indocyanine green (ICG) may help preventing AL. Available studies on the effects of IOFA with ICG are heterogeneous and randomized controlled trial are scarce. Our aim is to demonstrate that IOFA with ICG could lead to a reduction of AL rate after left-sided or low anterior resection with anastomosis for CRC.

The FLUOCOL-1 study is the first national, multicenter, single blind, randomized, 2-arm, phase III superiority clinical trial. The primary endpoint is the occurrence of an AL 90 days post-operation. AL is defined as any anastomotic dehiscence with leakage into the pelvic cavity diagnosed upon imaging or at surgical exploration or any isolated pelvic organ-space infection with no evidence of fistula as defined by the International Study Group of Rectal Cancer.

The study population will be made of adult patients with left-sided or high rectal cancer scheduled to undergo elective left colectomy or high rectal resection (by open, laparoscopy or robotic surgery) and with expected stapled or hand-sewn intraperitoneal anastomosis. The exclusion criteria are mainly an emergent surgery; rectal cancer requiring total mesorectal excision and anastomosis expected below the peritoneal reflection; CRC requiring total or subtotal colectomy; CRC requiring transverse colectomy; recurrent CRC and locally advanced colorectal cancer requiring multi-visceral excision.

A total of 1010 patients will be necessary (39 patients in each centre during 36 months). An interim analysis for efficacy and futility is scheduled when half of the participants will have been recruited.

In case of positive results favoring IOFA, this study would define the use of IOFA as a standard of care in colorectal surgery. At the patient level, a significantly lower rate of AL will reduce hospital stay and stoma rate, and will ensure improved postoperative recovery, faster return to normal activity and better long-term oncologic outcomes.

status: Recruiting

ReferenceType: background

ReferenceCitation: Wojcik M, Doussot A, Manfredelli S, Duclos C, Paquette B, Turco C, Heyd B, Lakkis Z. Intra-operative fluorescence angiography is reproducible and reduces the rate of anastomotic leak after colorectal resection for cancer: a prospective case-matched study. Colorectal Dis. 2020 Oct;22(10):1263-1270. doi: 10.1111/codi.15076. Epub 2020 May 18.

lead_sponsor: Centre Hospitalier Universitaire de Besancon

location_facility: Centre Hospitalier Universitaire de Rouen

location_facility: Centre Hospitalier Universitaire de Grenoble

location_facility: Centre Hospitalier Universitaire de Besançon

location_facility: Centre Hospitalier Universitaire Amiens-Picardie

location_facility: Centre Hospitalier Universitaire de Strasbourg

location_facility: Centre Hospitalier Universitaire de Lille

location_facility: Clinique Chirurgicale De Saint Omer Blendecques

status_simplified: Ongoing

appel_a_projets: PHRCK

region: Bourgogne-Franche-Comté

nom_etablissement: CHU BESANCON

type_etablissement: CH

titre: FLUOCOL-1-Intérêt de la fluorescence à l'indocyanine en chirurgie colorectale pour la réduction du risque de fistule anastomotique : un essai ouvert randomisé multicentrique de phase III (essai intergroupe FRENCH-GRECCAR)

discipline_principale: cancer

nom_porteur: LAKKIS

prenom_porteur: Zaher


title: Assessment of Professional Practices in Muscle Rehabilitation of Chronic Hemodialysis

acronym: REHABIMUS

summary: Aim of this study is to evaluate, in a population of chronic kidney disease patients on dialysis (Stage 5D), the effect of a muscle strengthening program (training against resistance vs endurance training by elliptical bike) during a observational period (12 weeks per program) on frailty, risk of falling, muscle strength and mass, endurance, physical activity, quality of dialysis, nutritional status and neuromuscular sensitivity.

ipd_sharing_description: NC

lead_sponsor: University Hospital, Montpellier

intervention_type: Procedure


title: Efficiency of Combined Rehabilitation Programs Including Resistance and Endurance Exercises on Functional Capacities, Quality of Life and Daily Level of Activities in Hemodialysis Patients: a Comparative Study of Current Practices.

acronym: DIALEX

summary: Hemodialysis patients display among the lowest level of daily activities and decline of functional abilities is highly correlated with mortality. Perdialytic exercise during hemodialysis procedure is now part of the patients' routine care and appears to be a solution to struggle against the functional skills decrease. Our team was able to demonstrate that beyond muscle mass, muscle strength and physical activity were essential determinants of morbidity and mortality of dialysis patients. The AIDER Santé medical team has set up an assessment of physical activities and muscle strength in the Montpellier and Nimes centers. In order to rehabilitate muscle strength and endurance, perdialytic exercise may be prescribed. Its effectiveness can be appreciated by measuring the SPPB score (Short Physical Performance Battery). Recent studies established that combined training including resistance and endurance exercises was the most effective to improve functional performance. In AIDER Santé dialysis centers, the two mainly used exercise approaches are distinguished by the time distribution of the two types of exercise: the first plans to practice both types of exercise at each session (continuous program), the second plans to alternate a week of resistance exercise with a week of endurance exercise (discontinuous program). It is established that the rehabilitation of the hemodialysis patient must include both resistance and endurance exercises, but the combination of these exercises during the same session is potentially at the origin of an interference phenomenon, limiting neuromuscular adaptations specific to each effort. Therefore, the main hypothesis of the project is that the temporal separation of resistance and endurance exercises in a discontinuous program could optimize the functional gains of combined rehabilitation and therefore be more effective than a continuous program generating a phenomenon of interference.


acronym: AUTOHYPNOSE-TP

summary:
Patients benefitting from a lung transplantation are subject to long-lasting and often severe post-operative pain. Self-hypnosis has been proven effective in the management of acute pain.

The study hypothesis is that pre-operative training in self-hypnosis given to patients awaiting lung transplantation, will result in a reduction of post-operative pain one month after surgery.

status: Terminated

primary_purpose: Supportive Care

lead_sponsor: Fondation Ophtalmologique Adolphe de Rothschild


title: Subclinical Cardiovascular Impairments in Patients With Obstructive Sleep Apnea Syndrome

acronym: INFRASAS

summary:
Which are the anthropometric parameters and/or of severity of the syndrome of apnea of sleep (SAS) which make it possible to anticipate occurred of vascular anomalies, anatomical and/or functional precociously found among patients SAS? Secondary objectives:

Which are the anthropometric parameters and/or of severity of SAS allowing to anticipate occurred of early of the cardiac function and/or rhythmic anomalies found among patients SAS?
Do there exist biological markers who allow to anticipate the early vascular lesions or the anomalies beginners of the cardiac function?
Which are the cardiovascular effects of a treatment of SAS by Continuous Positive Pressure (PC) after 3 to 6 months of treatment?
Do the identified early cardiovascular attacks and/or the biological anomalies make it possible to predict occurred of cardiovascular events in this population of patients carrying SAS (followed longitudinal at 5 years)?

ReferenceCitation: Lattimore JD, Celermajer DS, Wilcox I. Obstructive sleep apnea and cardiovascular disease. J Am Coll Cardiol. 2003 May 7;41(9):1429-37. doi: 10.1016/s0735-1097(03)00184-0.

ReferenceCitation: Parish JM, Somers VK. Obstructive sleep apnea and cardiovascular disease. Mayo Clin Proc. 2004 Aug;79(8):1036-46. doi: 10.4065/79.8.1036.

ReferenceCitation: Shamsuzzaman AS, Gersh BJ, Somers VK. Obstructive sleep apnea: implications for cardiac and vascular disease. JAMA. 2003 Oct 8;290(14):1906-14. doi: 10.1001/jama.290.14.1906.

ReferenceCitation: Marin JM, Carrizo SJ, Vicente E, Agusti AG. Long-term cardiovascular outcomes in men with obstructive sleep apnoea-hypopnoea with or without treatment with continuous positive airway pressure: an observational study. Lancet. 2005 Mar 19-25;365(9464):1046-53. doi: 10.1016/S0140-6736(05)71141-7.

ReferenceCitation: Drager LF, Bortolotto LA, Lorenzi MC, Figueiredo AC, Krieger EM, Lorenzi-Filho G. Early signs of atherosclerosis in obstructive sleep apnea. Am J Respir Crit Care Med. 2005 Sep 1;172(5):613-8. doi: 10.1164/rccm.200503-340OC. Epub 2005 May 18.

ReferenceCitation: Stanke-Labesque F, Pepin JL, de Jouvencel T, Arnaud C, Baguet JP, Petri MH, Tamisier R, Jourdil JF, Levy P, Back M. Leukotriene B4 pathway activation and atherosclerosis in obstructive sleep apnea. J Lipid Res. 2012 Sep;53(9):1944-51. doi: 10.1194/jlr.P022814. Epub 2012 Jul 3.

lead_sponsor: University Hospital, Grenoble

collaborators: Centre Hospitalier Universitaire de Saint Etienne

location_facility: France : Laboratoire d'explorations fonctionnelles du système nerveux - Functional explorations laboratory of nervous system

location_facility: France : Laboratoire EFCR - Functional cardiorespiratory explorations laboratory


title: Pathophysiological Mechanisms of Fibromuscular Dysplasia

acronym: MeDyA

summary: Fibromuscular dysplasia is an non inflammatory non atherosclerotic obstructive arterial disease affecting mid-size arteries. It is considered as a rare vascular disease of unknown origin. Fibromuscular dysplasia may become symptomatic depending on location and severity of narrowing of the arterial lumen. for example,when a stenosis develops within a renal artery, arterial hypertension may develop. The cause of fibromuscular dysplasia is unknown. Several factors have been suggested to be associated with it: tobacco abuse or oestrogens. In order to progress into identifying possible causative mechanisms of the disease, we design a pathophysiology study destined to assess endothelial function in patients with fibromuscular dysplasia and to identify possible plasmatic biomarkers of the disease.

design_allocation: Non-Randomized

ReferenceCitation: Bruno RM, Marais L, Khettab H, Lorthioir A, Frank M, Jeunemaitre X, Laurent S, Boutouyrie P, Azizi M. Deep Vascular Phenotyping in Patients With Renal Multifocal Fibromuscular Dysplasia. Hypertension. 2019 Feb;73(2):371-378. doi: 10.1161/HYPERTENSIONAHA.118.12189.

oa_host_type: publisher

evidence: open (via free pdf)

host_type: publisher

version: publishedVersion

repositories_concat: closed

unpaywall_oa_status: bronze

publisher_dissemination: Wolters Kluwer Health

lead_sponsor: Assistance Publique - Hôpitaux de Paris

sponsor_collaborators:
Assistance Publique - Hôpitaux de Paris
Fondation pour la Recherche Médicale


title: Casting Light on HOst-cytomegaloviRUs Interaction in Solid Organ Transplantation

acronym: HORUS

summary:
CMV disease remains the most frequent infectious complication post-transplant and it is associated to high morbidity and even mortality. Global efforts from both transplant physicians and researchers in the field is needed to better characterize the host-virus interactions in the transplant setting, with the aim of decreasing the burden of disease and improve the well-being of patients.

"HORUS" (Casting light on HOst-cytomegaloviRUs interaction in Solid organ transplantation) study is a European research project, funded by the European Commission (Horizon Europe) involving 16 partners in seven European countries (France, Spain, Czech Republic, Belgium, Switzerland, Germany and Italy) aiming to better characterize the host-CMV interactions in SOT recipients. The first aim of HORUS study will be to build a European cohort of SOT recipients including clinical characterization and the constitution of a biocollection, which is the aim of HORUS cohort, in order to perform biological, immunological, gene expression, viral kinetics and deep viral genome characterization in the global European HORUS project to improve our understanding of the development of a CMV immune response in the context of immunosuppression.

lead_sponsor: University Hospital, Bordeaux

sponsor_collaborators:
University Hospital, Bordeaux
European Commission

location_facility:
Hôpital Rangueil
Hôpital Paul Brousse
Hopitel Pellegrin
Hôpital Foch
Hôpital Edouard Hériot
Hôpital LA PITIE SALPETRIERE
Hôpital Necker


title: ANRS HC 22, PEGLIST-C, Multicenter, Randomized Controlled Trial of Pioglitazone vs. Placebo in Association With Pegylated Interferon and Ribavirin in Patients With Chronic Hepatitis C, Non 2 or 3 Genotypes and Insulin Resistance

acronym: PEGLIST C

summary: The purpose of this study is to test whether the correction of insulin resistance with pioglitazone, will improve the response to antiviral treatment.

lead_sponsor: French National Agency for Research on AIDS and Viral Hepatitis

location_facility: Hôpital Pitié Salpêtrière, Service d'hépatogastroentérologie


title: Comportemental and Neuropsychologic Study of Children With Neurofibromatosis Type 1 Treated by Methylphenidate. A Double-blind Randomised Study Methylphenidate Versus Placebo

summary: Neurofibromatosis type 1 (NF1) is an autosomal dominant disorder with an estimated prevalence of 1/2190 to 1/6711. Attention deficit hyperactivity disorder (ADHD) has been reported to be common in NF1. We, the researchers at Hospices Civils de Lyon, designed a randomized, double blind, placebo controlled, crossover trial with a total follow-up duration of 9 weeks to evaluate the effect of methylphenidate (MPH) on the improvement on the simplified parents Conners' Rating Scale. In a parallel exploratory study we will compare the nature of attention deficit disorders in NF1 children to 30 ADHD NF1-free controls. Children aged 7 to 12 years are eligible when their intelligence quotient (IQ) is between 80 and 120. Fifty subjects (25 for each period) were required for testing the primary study hypothesis.

ReferenceCitation: Lion-Francois L, Gueyffier F, Mercier C, Gerard D, Herbillon V, Kemlin I, Rodriguez D, Ginhoux T, Peyric E, Coutinho V, Breant V, des Portes V, Pinson S, Combemale P, Kassai B; Reseau NF1 Rhone Alpes Auvergne-France. The effect of methylphenidate on neurofibromatosis type 1: a randomised, double-blind, placebo-controlled, crossover trial. Orphanet J Rare Dis. 2014 Sep 10;9:142. doi: 10.1186/s13023-014-0142-4.

oa_colors: green gold

oa_host_type: publisher;repository

evidence: oa journal (via doaj)

license: cc-by

license_normalized: cc-by

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

repository_institution: PubMed Central - Europe PMC

repository_normalized: PubMed Central

evidence: oa repository (via pmcid lookup)

repositories:
HAL
PubMed Central

repositories_concat: HAL;PubMed Central

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

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

unpaywall_oa_status: gold

publisher_dissemination: Springer

lead_sponsor: Hospices Civils de Lyon


title: Thromboembolic Risk Stratification by TRIP Score (Cast) to Guide Physicians in Preventive Treatment Prescriptions for Patients With Lower Limb Trauma Requiring Brace or Casting.

acronym: CASTING

summary:
Non-surgical traumas to the lower limbs that require orthopedic immobilisation (plaster or splint) are a frequent reason for going to accident and emergency. Due to venous stasis caused by immobilisation, hypercoagulable states and vascular injuries brought on by the trauma, these patients are at risk of developing VTE. For this reason, it is current practice in France and Belgium for the majority of patients to receive a preventative anticoagulant treatment. However, the benefit of this treatment, which has a considerable cost, is controversial. Contrary to French recommendations, American recommendations from 2012 actually advise against systematic preventative medicine, with prevention appearing to be effective primarily in studies with restrictive inclusion criteria. The most significant randomised controlled study on the subject did not show the benefit of low-molecular-weight heparin (LMWH) on the rate of symptomatic VTE among 1,435 non-selected patients. Therefore, in 2017, the Cochrane meta-analysis concluded that stratification of the risk of thromboembolism is required.

For this purpose, in collaboration with the Dutch team of Nemeth et al. we have recently developed a risk stratification model that takes into consideration the patient's characteristics, the type of immobilisation and the severity of the trauma: the TRiP(cast) score. This score is applied retrospectively to a large cohort and demonstrates excellent prognostic performances (AUC (area under the curve) of 0.74). In addition, when using a <7 limits, it makes it possible to identify a large group of patients at very low risk of developing VTE (negative predictive value: 99.2%).

The aim of the CASTING study is to prospectively demonstrate the reliability and utility of the TRiP(cast) score by showing that patients with orthopaedic immobilisation of a lower limb who are not receiving preventative treatment on the basis of a TRiP(cast) score of <7 have a very low rate of symptomatic VTE, which allows for a significant reduction in prescriptions of anticoagulants in comparison with prior practices.

ReferenceCitation: Douillet D, Riou J, Thoma M, Moumneh T, Darsonval A, Trinh-Duc A, Hugli O, Chauvin A, Penaloza A, Roy PM. Thromboembolic risk stratification by TRiP(cast) score to rationalise thromboprophylaxis in patients with lower leg trauma requiring immobilisation: a study protocol of the casting stepped-wedge cluster randomised trial. BMJ Open. 2021 Jun 28;11(6):e045905. doi: 10.1136/bmjopen-2020-045905.

license: cc-by-nc

license_normalized: cc-by-nc

repository_institution: Université de Lausanne - SERVAL

repositories_concat: PubMed Central;serval.unil.ch

publisher_dissemination: British Medical Journal

ipd_sharing_description: Individual participant data will not be available. The study protocol, the Statistical Analysis Plan, Informed consent form will be available immediately following publication. No end date.

lead_sponsor: University Hospital, Angers

collaborators: Cliniques universitaires Saint-Luc- Université Catholique de Louvain

location_country: Belgium France

location_facility: Centre Hospitalier Universitaire de Nantes

location_facility: Centre Hospitalier Universitaire de Tours

location_facility: Centre Hospitalier Universitaire de Toulouse

location_facility: Centre Hospitalier Universitaire de Rennes

location_facility: Centre Hospitalier Universitaire de Poitiers


title: Randomised Comparative Prospective Study of the Treatment of Female Stress Urinary Incontinence Due to Intrinsic Sphincter Deficiency : ACT™ Balloon Versus Artificial Urinary Sphincter ( AMS800™)

acronym: SU-ACT

summary:
The main objective is to compare the efficacy of AMS800 ™ and ACT ™ devices for the Treatment of Female Stress Urinary Incontinence due to Intrinsic Sphincter Deficiency on "social continence" at 6 months.

Continence is defined by the average number of pads used per day. The social continence is defined by (0-1) pad per day

location_facility: Urology Department, Pitié-Salpêtrière University Hospital

appel_a_projets: PHRCN

acronyme: SU ACT

titre: Etude prospective, multicentrique, comparative randomisée du traitement de l'incontinence urinaire d'effort par insuffisance sphinctérienne chez la Femme : Ballon ACT® versus Sphincter urinaire artificiel.

discipline_principale: urologie

nom_porteur: CHARTIER KASTLER

prenom_porteur: Emmanuel


title: Liver Transplantation in Patients With Hepatitis C Virus (HCV) and Human Immunodeficiency Virus (HIV) Coinfection ANRS HC08 Thevic

summary: To show the feasibility of liver transplantation in HCV-HIV coinfected patients. To study the two-year survival after transplantation, the interaction between HCV and HIV after transplantation, the influence of HIV on HCV recurrence after transplantation, the interaction between immunosuppressive and antiretroviral drugs in particular anti-proteases, immunological follow-up and quality of life of these patients

sponsor_collaborators: French National Agency for Research on AIDS and Viral Hepatitis

location_facility: Centre hepato biliaire hopital paul Brousse


title: A French, Multicentre, Open-label, Observational Study to Assess Quality of Life and Satisfaction in Subjects Taking PecFent® for the Treatment of Breakthrough Cancer Pain (BTPc)

acronym: Qualipec

summary:
National multicenter, prospective, observational study in cancer patients with chronic background pain and breakthrough pain to whom PecFent® has been prescribed under pragmatic condition by a specialist in the treatment of cancer pain conditions.

• Study objectives include assessment of early treatment satisfaction.

lead_sponsor: Archimedes Development Ltd


title: Immunonutrition to Improve Quality of Life of Upper Gastrointestinal Cancer Patients Undergoing Oncological Treatment

acronym: Neoimmune

summary: The purpose of this study is to compare the health-related quality of life following dietary supplementation with an immunonutrition formulation vs an isocaloric/isoprotein control diet supplement in patients suffering from upper digestive tract neoplasia undergoing oncological treatment.

lead_sponsor: Société des Produits Nestlé (SPN)

location_facility: Centre Hospitalier Régional Universitaire de Lille

intervention_type: Dietary Supplement


title: Comparison of Monotherapy With Protracted Superpotent Topical Steroids to Superpotent Topical Steroids Associated With Methotrexate in Bullous Pemphigoid

acronym: BP/MTX

summary: This controlled multi-center randomized clinical trial, with direct individual benefit, will compare efficacy and safety of two strategies in non-localized BP care: a combined regimen using initial superpotent topical steroids associated with methotrexate for 4 weeks followed by methotrexate alone for 8 months and superpotent topical steroids alone maintained 9 months (current standard of care). The expected result is an equivalence between the two compared strategies in terms of safety and efficacy, MTX monotherapy during the maintenance phase being easier to manage and therefore associated with better compliance than topical steroids with less cutaneous side effects and most cost-effective.


title: Benefits and Tolerance of Exercise in Patients With Generalized and Stabilized Myasthenia Gravis

acronym: MGEX

summary: The purpose of this study is to demonstrate that a 3 months physical exercise programme improves the Quality of Life of patients with generalized Myasthenia Gravis (MG) stabilized since at least 6 months under prednisone and/or azathioprine.

ReferenceCitation: Birnbaum S, Porcher R, Portero P, Clair B, Demeret S, Eymard B, Gargiulo M, Louet E, Berrih-Aknin S, Le Panse R, Aegerter P, Hogrel JY, Sharshar T; MGEX Study Group. Home-based exercise in autoimmune myasthenia gravis: A randomized controlled trial. Neuromuscul Disord. 2021 Aug;31(8):726-735. doi: 10.1016/j.nmd.2021.05.002. Epub 2021 May 27.

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

ReferenceCitation: Birnbaum S, Hogrel JY, Porcher R, Portero P, Clair B, Eymard B, Demeret S, Bassez G, Gargiulo M, Louet E, Berrih-Aknin S, Jobic A, Aegerter P, Thoumie P, Sharshar T; MGEX Study Group. The benefits and tolerance of exercise in myasthenia gravis (MGEX): study protocol for a randomised controlled trial. Trials. 2018 Jan 18;19(1):49. doi: 10.1186/s13063-017-2433-2.

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

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - CEA - Commissariat à l’énergie atomique

publisher_dissemination: Springer-Nature

location_facility: ICU and medical surgery department, Raymond Poincaré Hospital

intervention_type: Behavioral


title: Impact of a Protocol for Announcing the Limitation and Discontinuation of Therapies in the Emergency Departments on the Stress of Families

acronym: DISCUSS

summary:
Death is a daily reality in the emergency department. Deaths represent 0.3 to 0.5% of emergency admissions, i.e. approximately 26,000 per year for the whole of France. For 80% of these deceased patients, a decision of withholding and withdrawing life-sustaining treatments was made in the emergency departments. The announcement of death and decision of withholding and withdrawing life-sustaining treatments in this context is complex because of the lack of time and the inappropriate places for the announcement. In addition, the short delay in the occurrence of these events may increase the stress and anxiety of families who are unprepared for the announcement. However, there is little data in the literature on the impact on families in terms of their experience of announcements in the emergency context.

It has been established that symptoms of anxiety and depression are correlated with the onset of posttraumatic stress disorder and that the latter is more important in the families of deceased patients and after a decision to undergo decision of withholding and withdrawing life-sustaining treatments in the intensive care unit. In order to identify it, several tools have been developed, including the Impact Event Scale (IES), which has been widely used to detect symptoms related to PTSD.

It has also been shown that training nursing staff in communication skills or the use of written support in dealing with the families of patients who have died in intensive care reduces the appearance of post-traumatic stress symptoms.

Human simulation is a pedagogical technique for learning interpersonal skills through role playing. It is used, among other things, in announcement situations in medicine. Nevertheless, its impact in emergency medicine has not been evaluated.

Moreover, it has been shown that the involvement of the patient-partner in the care process must be improved and encouraged and that its impact has yet to be evaluated. Therefore, the objective is to evaluate the impact of a model protocol for announcing decision of withholding and withdrawing life-sustaining treatments, with human simulation and the intervention of partner families in a simulation center and in situ, on the reduction of family stress following the announcement of a decision of withholding and withdrawing life-sustaining treatments in the emergency departments.

Hypothesis is that training all emergency department caregivers in the use of a model announcement protocol with the support of human simulation, combining training of pairs in a simulation center and in situ training, and the participation of partner families, would allow for a better understanding of announce of withholding and withdrawing life-sustaining treatments decision in the emergency department and reduce their impact on families in terms of the occurrence of acute stress and post-traumatic stress symptoms.

study_start_date_type: Anticipated

status: Not yet recruiting

location_facility: Groupement hospitalier centre, Hospices Civils de Lyon

location_facility: Groupement hospitalier nord, Hospices Civils de Lyon

location_facility: Groupement hospitalier sud, Hospices Civils de Lyon


title: Evaluation of Standardized Management of Knee Arthritis Patients

acronym: ARTIST

summary: International recommendations (ACR,EULAR) emphasize physical exercise and weight loss for patients suffering from knee osteoarthritis. Nevertheless, number of patients receiving advices for these 2 points still low. This study evaluates the impact of a standardized medical intervention (patient education, weight reduction and physical exercise) in knee osteoarthritis patients.

primary_purpose: Educational/Counseling/Training

ReferenceCitation: Recommendations for the medical management of osteoarthritis of the hip and knee: 2000 update. American College of Rheumatology Subcommittee on Osteoarthritis Guidelines. Arthritis Rheum. 2000 Sep;43(9):1905-15. doi: 10.1002/1529-0131(200009)43:93.0.CO;2-P. No abstract available.

ReferenceCitation: Messier SP, Gutekunst DJ, Davis C, DeVita P. Weight loss reduces knee-joint loads in overweight and obese older adults with knee osteoarthritis. Arthritis Rheum. 2005 Jul;52(7):2026-32. doi: 10.1002/art.21139.

ReferenceCitation: Ravaud P, Flipo RM, Boutron I, Roy C, Mahmoudi A, Giraudeau B, Pham T. ARTIST (osteoarthritis intervention standardized) study of standardised consultation versus usual care for patients with osteoarthritis of the knee in primary care in France: pragmatic randomised controlled trial. BMJ. 2009 Feb 23;338:b421. doi: 10.1136/bmj.b421.

lead_sponsor: Almirall, SAS


title: Phase II Trial to Study the Tolerability and the Effectiveness of Imatinib in Patients With Chronic Myelogenous Leukemia in Chronic Phase in Relapse After Allogeneic Stem Cell Transplantation

summary: The aim of this phase II trial is asses the tolerability and the effectiveness of imatinib in patients with chronic myelogenous leukemia in chronic phase who are in relapse after stem cell transplantation.

lead_sponsor: Poitiers University Hospital

sponsor_collaborators:
Poitiers University Hospital
Novartis


title: Ultrasound-guided Median Nerve Block With Dextrose 5% Hydrodissection: Determination of the Minimal Effective Volume of Local Anesthetic

acronym: VMAL

summary:
Ultrasound guidance can reduce the required local anesthetic volume for successful peripheral nerve block.

The aim of the study is to determine the minimum volume of local anesthetic to achieve an ultrasound-guided median nerve block with a dextrose 5% hydrodissection approach.

ReferenceCitation: Dufour E, Jaziri S, Novillo MA, Aubert L, Chambon A, Kutz R, Vallee A, Fischler M. A randomized trial to determine the minimum effective lidocaine volume for median nerve block using hydrodissection. Sci Rep. 2022 Jan 7;12(1):52. doi: 10.1038/s41598-021-03660-7.

repositories_concat: PubMed Central

lead_sponsor: Hopital Foch

location_facility:
Hopital privé de l'Ouest Parisien
Centre Hospitalier de la Côte Basque


title: A Multicentric National Phase II Trial Assessing TIslelizumab in Monotherapy for Patients With Hepatocellular Carcinoma Child-Pugh B and ALBI Grade 1 or 2 Liver Function Score

acronym: HESTIA

summary:
Liver cancer is the third leading cause of cancer-related deaths worldwide. The majority of primary liver cancers occur as hepatocellular carcinoma (HCC), the incidence of which is increasing in many parts of the world. The vast majority of HCC cases occur in the setting of liver cirrhosis, usually due to chronic viral infections with hepatitis C or hepatitis B, alcohol consumption, non-alcoholic fatty liver disease or diabetes. The degree of underlying liver disease, as well as the stage of the tumour and the general condition of the patients, should therefore be taken into account when deciding on the treatment of HCC. Most patients with HCC have advanced disease at the time of diagnosis, or have recurrent disease after potentially curative treatments.

Tislelizumab showed enhanced cellular functional activities by blocking PD-1-mediated reverse signal transduction and activating human T cells and primary peripheral blood mononuclear cells in vitro.

Based on this preliminary safety profile, and knowing that there is antitumour activity, we can offer tislelizumab as a single agent in patients with unresectable HCC.

HESTIA study is a multicentric French national phase II trial assessing tislelizumab in monotherapy for patients with Hepatocellular Carcinoma Child-Pugh B and ALBI grade 1 or 2 liver function score.

It is planned to include 50 patients in the study. All patients will be recruited in France. The study will be presented to eligible patients at participating centres and an information note will be provided. No advertising material is planned for this study.

To be eligible, patients must meet all the following criteria to be ≥18 years old, with histologically proven Hepatocellular Carcinoma (HCC), pre-treated or not with a tyrosine kinase inhibitor and Child-Pugh B cirrhosis, ALBI (Albumin-Bilirubin) grade 1 or 2 and BCLC (Barcelona Clinic Liver Cancer Group) B or C and with no more than 50% liver invasion of tumour disease.

lead_sponsor: UNICANCER

location_facility:
CHU Beaujon
Centre Eugene Marquis
CHU La Croix Rousse
CHU Saint Eloi
Hôpital Saint Joseph
CHU Angers


title: Treatment by Subcutaneous Continuous Infusion of Insulin by Portable Pump Versus Discontinuous Infusion of Insulin by Multi-injections in the Type 2 Diabetes: Study of the Insulinosensibility in the 2 Types of Treatments

summary:
The aim of the TRICIDIA2 study is to compare two modalities of administration of insulin.

In our future study, the investigators wish to study if the treatment by continuous infusion of insulin improves the insulinosensitivity of type 2 diabetic patients; the investigators indeed expect that the insulin delivered in a continuous way decreases the insulino-resistance of these patients compared with the intermittent delivering of insulin.

lead_sponsor: Centre Hospitalier Universitaire Dijon


lead_sponsor: EspeRare Foundation

summary: In Duchenne Muscular Dystrophy (DMD) there is an imbalance between the levels of calcium and sodium in the muscles cells which is thought to be important in the damage which occurs overtime. Sodium/proton type 1 exchanger (NHE-1) inhibition is an innovative pathway that has proved to efficiently prevent the accumulation of muscle damage (inflammation and fibrosis) in animal models of muscular dystrophies and heart failure. Based on prior safety and efficacy results in animal and humans, NHE-1 inhibition with Rimeporide represents a new therapeutic approach with no restriction on age and on genetic subtypes which could be combined to other treatments that restore or augment dystrophin.This study examines the safety and tolerability and effects on the muscles of rimeporide, in patients aged 6 to 14 years with Duchenne Muscular Dystrophy (DMD).

location_facility: UCL Institute of Child Health and Great Ormond Street Hospital

title: A Phase Ib, Open Label Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Ascending Oral Doses of Rimeporide in Patients With Duchenne Muscular Dystrophy

source: euctr

location_country:
Italy
United Kingdom
Spain
France


title: Pilot Study Evaluating Maraviroc (Celsentri®)Intensification Benefit in HIV Infected Patients Presenting Insufficient Immune Restoration Despite Controlled Viral Load With Antiretroviral Treatment. ANRS 145 MARIMUNO

acronym: 145 MARIMUNO

summary:
This pilot study aims to evaluate Maraviroc intensification strategy during 24 weeks in HIV infected patients under efficient (CV< 50 cp/mL), controlled antiretroviral therapy (≥ 6 months) and uncompleted immune restoration (CD4<350 cells/mL and CD4 earning <100 cells/mL during last 24 months).

The study will include 60 patients whose follow up is carried out for 48 weeks. recruitment period will be maintained for 12 months.

location_facility: French National Agency for Research on AIDS and Viral Hepatits


title: Evaluation of the Effect of a 28-day B.Lactis Consumption Twice Daily on Gastro-Intestinal (GI) Symptoms in Healthy Women Reporting Minor GI Symptoms. A Proof of Efficacy, Randomized, Controlled, Double-blind, Parallel Arms, Adaptive Design.

summary: The purpose of this study is to assess the effect of a 28-day B.lactis consumption twice daily on Gastro-Intestinal (GI) symptoms in healthy women reporting minor GI symptoms.

lead_sponsor: Danone Research

sponsor_collaborators:
Danone Research
Euraxi Pharma


title: Impact of Beverage Consumption With Varying Sweetening Systems During Meal on Post-prandial Glucose and Insulin Concentrations, and Lipid Metabolism in Overweight and Obese Subjects

summary: The purpose of this clinical study is to investigate the effect of drinking a sugar-sweetened beverage along with a meal on insulin concentrations and, glucose and lipid metabolism, in overweight and obese subjects, during a 10-hour visit.


title: A Randomized, Parallel-Group, Multicentre, Open-Labelled, Active-Controlled Study to Assess the Efficacy, Safety and Tolerability of RV4104A Ointment Versus Bifonazole-Urea Ointment for the Complete Removal of the Clinically Infected Nail Plate Area in Patients With Toenail Onychomycosis

summary: The purpose of the study is to evaluate the efficacy of RV4104A ointment versus bifonazole-urea ointment for the complete removal of the clinically infected nail plate area in patients with toenail onychomycosis.

lead_sponsor: Pierre Fabre Dermo Cosmetique


title: Impact of the COVID-19 Pandemic on the Quality of Psychological Life of Healthcare Professionals

acronym: COVIDPROIMPACT

summary:
The COVID-19 pandemic is profoundly changing the way people live and work. After the health impact, it is the mental and psychological impact that reaches varying degrees in the entire world population. The previous Asian epidemics have had a lasting impact on the health professionals concerned.

In France, no study has yet assessed the psychological impact of this health crisis on the level of health professionals. Investigators propose to study prospectively the evolution of the state of stress and anxiety of all the professionals practicing within the gynecology-obstetrics departments of 18 French hospitals.

Investigators also hypothesize that the mental repercussions in terms of stress and anxiety within the same service could be different depending on the professional status and the place of exercise (the French regions being impacted in different ways).

In addition to the epidemiological interest, the results of this study may help us to target regions and professionals who will need psychological support during and after this serious health crisis.

location_facility: Gynécologie-Obstétrique CHU de Saint Etienne

location_facility: Gynécologie-Obstétrique Hôpital de la Pitié Salpêtrière (APHP)

location_facility: Gynécologie-Obstétrique Hôpital La Conception

location_facility: Gynaecology Department, Hôpital Femme Mère Enfant, Hospices Civils de Lyon

location_facility: Gynécologie-Obstétrique Hôpital de la Mère et de l'Enfant

location_facility: Gynécologie-Obstétrique Hôpital Antoine Béclère (APHP)

location_facility: Gynécologie-Obstétrique Maternité Port-Royal, Groupe Hospitalier Cochin-Broca- Hotel Dieu (APHP)

location_facility: Gynécologie-Obstétrique CHU Reims - Institut Mère Enfant Alix de Champagne

location_facility: Gynécologie-Obstétrique CHU Grenoble-Alpes, Hôpital Couple Enfant

location_facility: Gynécologie-Obstétrique Hôpital BICETRE (APHP)

location_facility: Gynécologie-Obstétrique Hôpital de Hautepierre

location_facility: Gynécologie-Obstétrique Hôpital de la Croix Rousse

location_facility: Gynécologie-Obstétrique Hôpital Jeanne de Flandre - CHRU Lille


title: Randomized Clinical Trial Evaluating Combined Pentoxifylline-tocopherol-clodronate vs Placebo in Radiation-induced Brachial Plexopathy: the PENTOCLO Trial

acronym: PENTOCLO

summary:
Radiation-induced brachial plexopathy (RIP) is a rare and severe delayed peripheral nerve complication of radiotherapy, that is spontaneously irreversible with no medical treatment to limit or reduce symptoms. The investigators planed in RIP a randomized double blind clinical trial, using a pentoxifylline (P)- tocopherol (E)- clodronate combination versus placebo, to assess a possible symptomatic regression by a sensory-motor neurological quantifiable and reproducible score (modified Subjective Objective Medical management Analytic, SOMA).

The investigators previously developed a successful PE treatment in symptomatic RI injuries via the antioxidant pathway, in clinical phase II and III trails and experiments obtaining a major significant radiation-induced fibrosis regression, then the PE clodronate combination (PENTOCLO), obtaining a rapid and significant healing of mandible osteoradionecrosis and significant neurological signs regression (- 35% modified SOMA score at 18 months) in 50 partial RIP.

The aim of this phase III randomized clinical trial is to show PENTOCLO efficiency and its tolerance in long survival patients irradiated before for cancer and presenting with partial RIP of upper or lower legs.

The investigators calculated to include 60 patients to show a significant clinical difference between the two groups after 18 months of treatment: PENTOCLO[Pentoxifylline 400 (2x/d) + vitamine E 500 (2x/d) + intermittent Clodronate 800 (2/d, 5d/7)] versus triple placebo, with prednisone 20 (2d/7) for all patients.

RIP is assessed before treatment and every 6 months by a standardized sensory-motor neurological (SOMA 95 modified by NCI-CTC 99) score used for main criteria at M18, and various neurological scales of assessment (Visual Analog Scale for pain / VAS for paresthesia, Neuropathic Pain Symptom Inventory [NPSI], Overall Disability Sum Score [ODSS], muscle testing, Nine hole peg test / Timed 25-Foot Walk), quality of life (SF36, Patient Global Impression of Change and Clinical Global impression of Change [PGIC/ CGIC]) and electrophysiology.

ReferenceCitation: Pradat PF, Maisonobe T, Psimaras D, Lenglet T, Porcher R, Lefaix JL, Delanian S. [Radiation-induced neuropathies: collateral damage of improved cancer prognosis]. Rev Neurol (Paris). 2012 Dec;168(12):939-50. doi: 10.1016/j.neurol.2011.11.013. Epub 2012 Jun 27. French.

location_facility:
Hôpital Saint-Louis
Groupe Hospitalier Pitié-Salpêtrière


title: A Multi-Centre, Open Label, Phase II Study of the Safety, Efficacy and Pharmacokinetic (PK) Profile of CAP-232 Administered Through Continuous Intravenous Infusion in Patients With Metastatic Kidney Cancer

summary: The purpose of this study was to evaluate the safety and efficacy of CAP-232 in the treatment of patients with previously treated (refractory) renal cell carcinoma

ReferenceCitation: Tejeda M, Gaal D, Hullan L, Hegymegi-Barakonyi B, Keri G. Evaluation of the antitumor efficacy of the somatostatin structural derivative TT-232 on different tumor models. Anticancer Res. 2006 Sep-Oct;26(5A):3477-83.

ReferenceCitation: Tejeda M, Gaal D, Hullan L, Csuka O, Schwab R, Szokoloczi O, Keri G. A comparison of the tumor growth inhibitory effect of intermittent and continuous administration of the somatostatin structural derivative TT-232 in various human tumor models. Anticancer Res. 2006 Jul-Aug;26(4B):3011-5.

ReferenceCitation: Gyergyay F, Gödény M, Sármay G, Kralovanszky J, Papp E, Gergye M, Vincze B, Kéri G, Bodrogi I : Antitumor activity and pharmacology of TT-232 (a novel somatostatin structural derivative) in malignant melanoma patients JCO, 2004 ASCO Annual Meeting Proceedings Vol 22, No 14S (July 15 Supplement), 2004: 3151

lead_sponsor: Thallion Pharmaceuticals

location_facility:
CRLC Val d'Aurelle Paul-Lamarque
Institut de Cancérologie de la Loire


title: Long-term Results of Per-oral Pyloromyotomy for Refractory Gastroparesis

summary:
This is a large multicenter retrospective French cohort conducted in seven French centers that had performed at least five G-POEM procedures at the end of 2017. All patients treated by G-POEM for refractory gastroparesis since April 30, 2014 (first case of GPOEM in France) in these seven centers were included in this study and followed until April 2019. The data were collected retrospectively regarding medical and technical data, and then prospectively for the following data, which were included in a database for each center and combined for analysis.

Gastric Cardinal Symptoms Index (GCSI) was used to evaluate symptoms and their severity. It applies a Likert scale ranging from 0 to 5 (5 being the highest score) for three subscales: satiety (mean of four items), nausea/vomiting (mean of three items), and bloating (mean of two items). The total GCSI score was the mean of the three subscales. A GCSI score ≥ 2.6 is considered moderate gastroparesis and ≥ 3 is considered severe.

Gastric emptying scintigraphy (GES) was used to confirm delayed gastric emptying, since it is considered the gold standard according to the American Society of Neurogastroenterology. Patients consume a radiolabeled meal, receive imaging at specific time-points to determine gastric retention. The exam is pathological when retention is > 90% after 1 hour, > 60% after 2 hours (H2), > 30% after 3 hours (H3), and > 10% after 4 hours (H4). All but one center performed the GES according to the US guidelines: that center performed a 3-hour GES with a local validation of a threshold of 30% retention at H3 to define delayed gastric emptying. A %H4 retention > 30% was defined as severe delayed gastric emptying.

time_perspective: Retrospective

ReferenceCitation: Gonzalez JM, Benezech A, Vitton V, Barthet M. G-POEM with antro-pyloromyotomy for the treatment of refractory gastroparesis: mid-term follow-up and factors predicting outcome. Aliment Pharmacol Ther. 2017 Aug;46(3):364-370. doi: 10.1111/apt.14132. Epub 2017 May 15.

ReferenceCitation: Khashab MA, Ngamruengphong S, Carr-Locke D, Bapaye A, Benias PC, Serouya S, Dorwat S, Chaves DM, Artifon E, de Moura EG, Kumbhari V, Chavez YH, Bukhari M, Hajiyeva G, Ismail A, Chen YI, Chung H. Gastric per-oral endoscopic myotomy for refractory gastroparesis: results from the first multicenter study on endoscopic pyloromyotomy (with video). Gastrointest Endosc. 2017 Jan;85(1):123-128. doi: 10.1016/j.gie.2016.06.048. Epub 2016 Jun 25.

ReferenceCitation: Jacques J, Pagnon L, Hure F, Legros R, Crepin S, Fauchais AL, Palat S, Ducrotte P, Marin B, Fontaine S, Boubaddi NE, Clement MP, Sautereau D, Loustaud-Ratti V, Gourcerol G, Monteil J. Peroral endoscopic pyloromyotomy is efficacious and safe for refractory gastroparesis: prospective trial with assessment of pyloric function. Endoscopy. 2019 Jan;51(1):40-49. doi: 10.1055/a-0628-6639. Epub 2018 Jun 12.

oa_host_type: closed

publisher_dissemination: Georg Thieme

ReferenceCitation: Revicki DA, Camilleri M, Kuo B, Szarka LA, McCormack J, Parkman HP. Evaluating symptom outcomes in gastroparesis clinical trials: validity and responsiveness of the Gastroparesis Cardinal Symptom Index-Daily Diary (GCSI-DD). Neurogastroenterol Motil. 2012 May;24(5):456-63, e215-6. doi: 10.1111/j.1365-2982.2012.01879.x. Epub 2012 Jan 27.

ReferenceCitation: Abell TL, Camilleri M, Donohoe K, Hasler WL, Lin HC, Maurer AH, McCallum RW, Nowak T, Nusynowitz ML, Parkman HP, Shreve P, Szarka LA, Snape WJ Jr, Ziessman HA; American Neurogastroenterology and Motility Society and the Society of Nuclear Medicine. Consensus recommendations for gastric emptying scintigraphy: a joint report of the American Neurogastroenterology and Motility Society and the Society of Nuclear Medicine. J Nucl Med Technol. 2008 Mar;36(1):44-54. doi: 10.2967/jnmt.107.048116. Epub 2008 Feb 20.

ReferenceCitation: Camilleri M, Parkman HP, Shafi MA, Abell TL, Gerson L; American College of Gastroenterology. Clinical guideline: management of gastroparesis. Am J Gastroenterol. 2013 Jan;108(1):18-37; quiz 38. doi: 10.1038/ajg.2012.373. Epub 2012 Nov 13.

ReferenceCitation: Ragi O, Jacques J, Branche J, Leblanc S, Vanbiervliet G, Legros R, Pioche M, Rivory J, Chaussade S, Barret M, Wallenhorst T, Barthet M, Kerever S, Gonzalez JM. One-year results of gastric peroral endoscopic myotomy for refractory gastroparesis: a French multicenter study. Endoscopy. 2021 May;53(5):480-490. doi: 10.1055/a-1205-5686. Epub 2020 Jul 21.

lead_sponsor: University Hospital, Limoges

location_facility:
Hospices Civiles Lyon
Cochin Hospital
University Hospital


acronym: ANRS STIMAGO

lead_sponsor: ANRS, Emerging Infectious Diseases

summary: This phase II pilot study aims at evaluating the benefits and the risks of methylphenidate (Concerta®) for the treatment of cocaine/crack dependence in terms of cocaine/crack use reduction and adverse events.

sponsor_collaborators:
ANRS, Emerging Infectious Diseases
Hopital Paul Brousse

status: Withdrawn

title: Pilot Study to Evaluate the Benefits and the Risks of Methylphenidate for the Treatment of Cocaine Dependence


title: Claudication Evaluation During Rowing ExerciseS. Rehabilitation Arteritis of Lower Limbs by Rowing

acronym: CERES

summary: Check the feasibility of the collection of reliable measures of tcpO2 the lower limbs in arteriopathy when performing rowing on effort.


title: Randomised Phase II/III Study, Assessing the Safety and Efficacy of Modified Folfirinox Versus Gemcis in Locally Advanced, Unresectable and/or Metastatic Bile Duct Tumours

acronym: AMEBICA

summary:
Bile duct tumours are rare. They are the 6th most common type of digestive cancer. Their therapeutic management is complex and must be multidisciplinary in nature. Most of the time, an endoscopic or radiological biliary drainage is necessary before any tumour treatment.

Their prognosis is poor due to the fact that they are normally diagnosed late, which makes curative surgery impossible. A population study in the Côte d'Or region of France reported a survival rate at 5 years of approximately 10%.

For the locally advanced or metastatic forms, treatment has not been properly codified. With respect to chemotherapy, prospective studies, most often phase II, are difficult to interpret due to a limited number of patients and due to the heterogeneity of this type of tumour (bile duct and pancreas tumours). Treatment with 5FU alone provides an objective response in approximately 10% of cases. In combination with mitomycin or carboplatin, the objective response rate is 20%, with a median survival period of 5 months. Interferon combined with 5FU has a better response rate (30%), but occurrences of different types of toxicity are more frequent.

More recently, gemcitabine and the 5FU-cisplatin combinations demonstrated objective tumour control in 50% of patients with a median survival period of 10 months. Gemcitabine combined with oxiplatin or with cisplatin has shown the same response rate but a median survival period of approximately 12 months.

The benefit of this combination has been confirmed in a phase III trial that compared the gemcitabine-cisplatin combination to gemcitabine alone, in 410 patients with locally advanced unresectable and/or metastatic bile duct cancer. The results were in favour of the combined treatment with a median survival period of 11.7 months (versus 8.1 months - HR 0.64 [0.52 - 0.80]). This combination is currently the reference first-line treatment.

ReferenceCitation: Phelip JM, Desrame J, Edeline J, Barbier E, Terrebonne E, Michel P, Perrier H, Dahan L, Bourgeois V, Akouz FK, Soularue E, Ly VL, Molin Y, Lecomte T, Ghiringhelli F, Coriat R, Louafi S, Neuzillet C, Manfredi S, Malka D; PRODIGE 38 AMEBICA Investigators/Collaborators. Modified FOLFIRINOX Versus CISGEM Chemotherapy for Patients With Advanced Biliary Tract Cancer (PRODIGE 38 AMEBICA): A Randomized Phase II Study. J Clin Oncol. 2022 Jan 20;40(3):262-271. doi: 10.1200/JCO.21.00679. Epub 2021 Oct 18.

publisher_dissemination: American Society of Clinical Oncology (ASCO)

lead_sponsor: Centre Hospitalier Universitaire de Saint Etienne

collaborators: Federation Francophone de Cancerologie Digestive

location_facility: Centre de radiothérapie et oncologie du Parc


title: Prevention of Hepatitis B Virus Mother-to-Child Transmission (MTCT) From HIV-HBV Co-infected Pregnant Women by Use of Nucleosides/Nucleotides Analogues With Dual Activity During Pregnancy.

summary: Vertical HIV transmission has been dramatically reduced by the use of combined antiretroviral therapy in HIV-infected pregnant women. Among the most often used drugs, several have dual activity, against HIV and HBV: lamivudine, emtricitabine, tenofovir. Studies about vertical HBV transmission from HIV-HBV co-infected pregnant women are rare in developed countries. The study hypothesis is a major reduction of the risk of HBV vertical transmission.

ReferenceCitation: Sellier PO, Schnepf N, Amarsy R, Maylin S, Lopes A, Mazeron MC, Flateau C, Morgand M, Ciraru-Vigneron N, Berthe A, Simoneau G, Evans J, Souak S, Matheron S, Benifla JL, Simon F, Bergmann JF. Short article: Hepatitis B virus status in children born to HIV/HBV coinfected women in a French hospital: a cross-sectional study. Eur J Gastroenterol Hepatol. 2016 Mar;28(3):328-32. doi: 10.1097/MEG.0000000000000559.

lead_sponsor: Hopital Lariboisière


title: Prevention of Hepatitis B Virus (HBV) Mother-to-Child (MTC) Transmission by Serovaccination of Newborns and Use of Tenofovir DF During the Last Trimester of Pregnancy in Mothers With HBV DNA Above 100, 000 I.U/mL

summary: The risk of vertical HBV transmission is related to HBV DNA level in pregnant women, around 30% in women with HBV DNA above 1, 000 000 I.U/mL despite serovaccination of newborns. Using tenofovir DF during the last trimester of pregnancy allows to reduce the risk, but data from Western countries are needed.

ReferenceCitation: Sellier PO, Maylin S, Bercot B, Chopin D, Lopes A, Simoneau G, Evans J, Delcey V, Benifla JL, Simon F, Bergmann JF. Prospective interventional study of tenofovir in pregnancy to prevent vertical transmission of hepatitis B in highly viremic women. Eur J Gastroenterol Hepatol. 2017 Mar;29(3):259-263. doi: 10.1097/MEG.0000000000000793.


title: A Study Comparing Intermittent Androgen Depriving Therapy With Or Without Salvage High-Dose Intensity Modulation Radiotherapy (IG-IMRT)To Oligometastatic Pelvic Lymph Nodes In Biochemically-relapsing Prostate Cancer Patients.

summary:
Metastatic prostate cancer has traditionally been regarded as an incurable dissemination of disease, and treatment is focused on delaying progression rather than eliminating all tumor burden. Local therapies, and specifically radiotherapy, have been directed at quality of life endpoints and not at improving survival. However, advances in imaging and systemic therapy have identified a population of 'oligometastatic' patients who have a lower burden of metastatic disease (usually ≤5 lesions), who may present an exception. This condition is hypothesized to occupy the hinterland between incurable metastatic disease and locoregional disease, where micrometastatic disease is assumed to exist and yet remain eradicable. Oligometastases can be detected using standard imaging but the sensitivity of these exams is very low for patients with a PSA below 10 ng/ml. In France, FCH PET imaging is now routinely available in a large majority of cancer centres. More recently, PSMA PET imaging has been developed.

Since most oligometastases are now discovered at a time when conventional imaging is unable to detect metastases, we must rely on the literature regarding purely biochemically-relapsing prostate cancer patients. Three strategies have been explored: (i) observation until symptoms develop, (ii) early intermittent Androgen Deprivation Therapy (IADT) and (iii) continuous Androgen Deprivation Therapy (ADT). Recent data suggest that, of the three strategies, early intermittent ADT was superior in term of overall survival to observation in controlling metastatic prostate cancer, and this effect was similar in the biochemically-relapsing prostate cancer patient population.

This phase III study will explore the role of salvage pelvic IG-IMRT combined with intermittent ADT (IADT) in pelvic oligometastatic patients in prolonging the first failure-free interval between the first and the second intermittent ADT courses.

status: Active, not recruiting

lead_sponsor: Institut Cancerologie de l'Ouest

sponsor_collaborators:
Institut Cancerologie de l'Ouest
Direction Générale de l'Offre de Soins
Astellas Pharma Inc

location_facility:
Centre Oscar Lambret
CHRU de Brest
Centre Léon Bérard
Clinique Mutualiste de l'Estuaire
Institut Bergonie
Centre Azureen de Cancerologie
Centre Saint Yves
ICL Lucien Neuwirth
Institut de Cancérologie de Montpellier
Institut de Cancérologie
Hopital Privé du Confluent
Clinique Pasteur
Institut de Cancérologie de Bourgogne
Institut Sainte Catherine
Centre Georges François Leclerc
Centre Jean Perrin


title: Effect of Lower Extremity Traction on the Popliteal Angle After Percutaneous Needle Tenotomy of the Knee Flexor Muscles.

summary:
People with neuromotor disability (i.e. following an inborn or acquired spinal cord, cerebral or peripheral neurological lesion) are at risk of neuro-orthopaedic disorders. Microinvasive percutaneous needle tenotomy is a frequent use alternative to open surgery to treat limb deformities. A lower extremity traction is performed in our unit during 2 to 7 days after surgery of the knee flexor muscles.

The aim of this study is to describe the efficiency of lower extremity traction on the popliteal angle after percutaneous needle tenotomy of the knee flexor muscles.

ReferenceCitation: Chesnel C, Genet F, Almangour W, Denormandie P, Parratte B, Schnitzler A. Effectiveness and Complications of Percutaneous Needle Tenotomy with a Large Needle for Muscle Contractures: A Cadaver Study. PLoS One. 2015 Dec 1;10(12):e0143495. doi: 10.1371/journal.pone.0143495. eCollection 2015.

ReferenceCitation: Schnitzler A, Genet F, Diebold A, Mailhan L, Jourdan C, Denormandie P. Lengthening of knee flexor muscles by percutaneous needle tenotomy: Description of the technique and preliminary results. PLoS One. 2017 Nov 7;12(11):e0182062. doi: 10.1371/journal.pone.0182062. eCollection 2017.

ReferenceCitation: Angioni F, Salga M, Denormandie P, Genet F, Haigh O, David R, Gatin L, Schnitzler A. Microinvasive percutaneous needle tenotomy, An alternative to open surgery to treat neurological foot deformities. Ann Phys Rehabil Med. 2023 Mar;66(2):101690. doi: 10.1016/j.rehab.2022.101690. Epub 2022 Nov 30. No abstract available.

lead_sponsor: Institut de Sante Parasport Connecte Synergies

location_facility: Department of Physical Medicine and Rehabilitation, Raymond Poincaré Hospital, AP-HP


title: Physical Activity in People With Sequelae of Poliomyelitis : a Cross-sectional Study

summary:
People with disabilities are less physically active than the general population. At present, the physical activity level of people with poliomyelitis sequelae and their barriers to physical activity are unknown.

The aim of this study is to describe the physical activity level of people with poliomyelitis sequelae and their barriers to physical activity.

time_perspective: Cross-Sectional

sponsor_collaborators: Institut de Sante Parasport Connecte Synergies


title: Barriers to Physical Activity in Patients With Cognitive, Neuromotor or Sensory Impairments During Aging

acronym: NO-BARRIERS

summary:
People with disabilities are less physically active than the general population. Their barriers to physical activity are multiple and include intrapersonal, organizational, societal and interpersonal reasons. Nevertheless, at present, the evolution of their barriers to physical activity and the short- and long-term impact of medical and medico-social treatments to limit them are unknown.

The aim of this study is to describe barriers to physical activity, or disability-related underperformance factors in competitive sports, in patients with cognitive, neuromotor or sensory impairments during aging.


title: Neuro-Orthopaedic Disorders During Aging in Patients With Neuromotor Disability

acronym: NO-AGING

summary:
People with neuromotor disability (i.e. following an inborn or acquired spinal cord, cerebral or peripheral neurological lesion) are at risk of worsening their neuro-orthopaedic disorders during aging, including fracture risk. Nevertheless, at the present time, the natural evolution of their neuro-orthopedic disorders and the long-term functional impact of their medical and surgical treatments is unknown.

The aim of this study is to describe neuro-orthopedic disorders during aging of patients with neuromotor disability, their functional repercussions, their comorbidities and the therapeutic strategies used.


type: Other Identifier

title: Early Ultrasound Screening of Heterotopic Ossification After Severe Neurological Trauma in a Post-intensive Care Rehabilitation Unit

acronym: POHER II

summary:
Prospective, bi-centric diagnostic, performance study on a new diagnostic procedure with ultrasounds against a reference diagnostic procedure.

The primary objective is to study the performance of ultrasound coupled with clinical examination at 1 week of admission for early screening of heterotopic ossification (HO) in patients admitted to a post intensive care rehabilitation unit (PICRU) after a severe neurologic trauma.

The CT scan at 5 weeks of admission is considered as the gold standard. CT scan reader will be blinded to clinical data.

primary_purpose: Diagnostic

lead_sponsor: Assistance Publique - Hôpitaux de Paris

sponsor_collaborators:
Assistance Publique - Hôpitaux de Paris
Fondation Paul Bennetot


title: Pharmacological Treatment of a Rare Genetic Disease: Pilot Trial Phase II-III With N-acetylcysteine in Myopathy Associated SEPN1-RM (Selenoprotein N-related Myopathy)

acronym: SelNac

summary: The objective of this study is to determine whether the administration of N-acetylcysteine (NAC) improves oxidative stress. To determine this, the study will assess the impact of oral treatment on the balance between reduced and oxidized form of glutathione in erythrocytes of peripheral blood.


title: "Validation of a Questionnaire Assessing Disability and Bothersomeness in Pulmonary Arterial Hypertension (PAH): The PAH Disability and Bothersomeness Questionnaire"

acronym: PAH-DBoQ

summary: To develop a patient-reported questionnaire to investigate the impact of PAH (pulmonary arterial hypertension) on patients' daily lives in terms of bothersomeness and disability.

lead_sponsor: Association de Recherche en Physiopathologie Respiratoire

collaborators: GlaxoSmithKline Soladis Interlis

location_facility: Centre de Référence de l'Hypertension Pulmonaire Sévère, Service de Pneumologie et Soins Intensifs, Hôpital de Bicêtre,


type: Registry Identifier

title: Consequences of Respiratory Devices on Caregivers: CAP2 Study

summary:
The promoter of the study will conduct a monocentric cohort study that aim to evaluate the consequences of home respiratory devices on patient caregivers' quality of life.

The investigators will examine the impact of home respiratory devices on quality of life in general, sleep quality, anxiety and humour depending on equipment type (Non-invasive ventilation (NIV), continuous positive airway pressure (CPAP) or long-term oxygen therapy (LTOT)) for patients and partners. The investigators will assess the correlation between patient and caregiver's answers. The investigators will assess the correlation between couple's quality of life and adherence to treatment.

To do this, the investigators will use four quality of life questionnaires and the investigators will collect demographic data, medical data and usage report from the equipment.

ipd_sharing: Yes

ipd_sharing_description: All specific individual participant data that underlie results in a publication will be made available upon reasonable request to the principal investigator

lead_sponsor: Asten Sante


title: Clinical and Microbiological Impact of Respiratory Viral Infections in the Short and Medium Term in Infants (<24 Months) With Cystic Fibrosis.

acronym: PREVIMUC

summary:
Respiratory Viral Infections (RVI) are particularly frequent in young children. Old data mention the deleterious role of some viruses such as the Respiratory Syncytial Virus in young children with cystic fibrosis (CF). However, recent epidemiological data on RVI in CF children are rare and the impact of most frequent viruses such as human rhinoviruses is usually not correctly evaluated.

The aim of this study is to assess the frequency of lower and upper RVI during a 1 year follow-up in CF infants and to evaluate the impact of RVI at a clinical, microbiological and therapeutic level.

Our hypothesis is that frequent and/or clinically severe RVIs have the worst impact in the short term and without any particular link with a specific virus as previously described.

lead_sponsor: Hospices Civils de Lyon

location_facility: Cystic Fibrosis Pediatric Reference Centrer, Hospices Civils de Lyon


title: Using Mother's Raw Milk Could Improve Breastfeeding in Hospitalized Neonates

acronym: DOAL

summary: Despite the importance of breast milk for sick or preterm neonates, there is currently no consensus regarding the use of raw mother's own milk (MOM) in neonatal units. The aims of this study are to: (a) describe factors associated with the use of raw MOM; (b) investigate the association between early use of raw MOM and breastfeeding continuation at discharge and up to 6 months later.

location_facility: Service de Réanimation Néonatale et Néonatologie, Hôpital Femme Mère Enfant, 32 Avenue Doyen Jean Lépine


title: First Single-blind Sequential Placebo-controlled Prospective Phase IIA Pilot Study Assessing the Effects of PXT00864 in Mild AD Patients

acronym: PLEODIAL-I

summary: The purpose of this study is to assess the safety and efficacy on cognitive impairment and functioning of several doses of PXT00864 (new fixed combination of acamprosate and baclofen at low dose) in patients with mild Alzheimer Disease.

lead_sponsor: Pharnext S.C.A.

sponsor_collaborators:
Pharnext S.C.A.
Ascopharm Groupe Novasco


title: Influence of Pravastatin on Carotid Artery Structure and Function in HIV-infected Patients Under Antiretroviral Therapy

summary:
The advent of new antiretroviral agents, in particular Highly Active Antiretroviral Therapy (HAART), spectacularly reduced HIV-associated morbidity and mortality. However, new complications have appeared in HIV-infected patients treated by with HAART such as dyslipidemia, insulin resistance, diabetes mellitus, and related cardiovascular complications including acute coronary syndromes, peripheral vascular disease, and stroke have been reported.

A linear association has been proved between increased intima-media thickness of the common carotid artery (CCA-IMT), aortic stiffness (pulse wave velocity [aPWV]) and incidence of cardiovascular events suggesting that IMT and aPWV could be considered as an early marker of atherosclerosis. The progression of IMT has been shown to be predictive of cardiovascular events. Case control and longitudinal studies but not all have suggested an increase CCA-IMT in HIV-infected patients under HAART compared with non-HIV infected patients with different progression.

The aim of this study was to examine the effects of pravastatin on CCA-IMT and aortic stiffness in dyslipidemic HIV-infected patients receiving HAART by using a high-resolution echotracking system.

Patients in the pravastatin group were consecutively recruited in four department of infectious diseases if they fulfilled the following criteria : (1) HIV-infected treated with HAART for > 12 months 2) with dyslipidemia, defined as fasting serum LDL cholesterol > 160 mg/dL before initiation of pravastatin, (3) treated with pravastatin > 12 months and one more coronary risk factor. The patients in the control group were selected consecutively in the same departments among 1) HIV-infected patients treated with HAART > 12 months 2) fasting serum LDL cholesterol > 160 mg/dL 3) without lipid-lowering drugs and one more coronary risk factor. Cases and control patients were matched for age, gender and tobacco consumption.

Using data from Mercie et al., inclusion of 42 patients in pravastatin and control groups was the minimum sample size needed for detection of a 6.5% difference in CCA-IMT, in a two-sided test (a = 0.05, b = 0.20).

The protocol of the study, sponsored by the French Society of Cardiology was approved by the Committee for the Protection of Human Subjects in Biomedical Research of Pitié-Salpétrière University hospital in Paris. Written informed consent to participate in the study was obtained from each patient.

lead_sponsor: Saint Antoine University Hospital

sponsor_collaborators:
Saint Antoine University Hospital
French Cardiology Society

location_facility: Department of Pharmacology and INSERM U652, Hôpital Européen Georges Pompidou


title: Randomized Prospective Study of Adding Lomustine to Idarubicin and Cytarabine for Induction Chemotherapy and Adding Intermediate Dose Cytarabine to Consolidation in Older Patients With Acute Myeloid Leukaemia

summary: A multicenter randomized trial was performed comparing induction therapy (IC: Idarubicin and Cytarabine, 5+7) to ICL (the same drugs plus lomustine (CCNU), 200mg\m2 orally at day 1). Patients in complete remission (CR) were then randomized to receive either maintenance therapy or intensification with intermediate-dose cytarabine and idarubicin followed by maintenance therapy.

lead_sponsor: French Innovative Leukemia Organisation


title: Assessment of Mobilization Cost for Multiple Myeloma Using 2 Different Mobilization Strategies: High-dose Cyclophosphamide Versus Plerixafor

acronym: MOZOBIL

summary:
This is a retrospective observational cohort database analysis. The study will review retrospectively the records of patients undergoing a first peripheral blood stem cell mobilization for multiple myeloma in the databases from approximately 15 hospitals which are part of the IFM collaborative group. Patient records will be divided into two groups of 50 patients minimum, maximum 100 patients or up to the number of patient records that could be extracted. The first group of patients will have received plerixafor plus G-CSF without the administration of chemotherapy as a mobilization strategy and a second group of patients will have received cyclophosphamide plus G-CSF as a mobilization strategy.

All consecutive patients with complete set of data (and who underwent apheresis) treated between 2009 and 2013 with G-CSF and plerixafor and all consecutive patients with complete data (and who underwent apheresis) treated between 2009 and 2013 with G-CSF and cyclophosphamide will be included.

All data that will be analyzed will be extracted from the selected IFM institutions which are located in France.

lead_sponsor: Intergroupe Francophone du Myelome

location_facility: Centre Hospitalier Universitaire (CHU) de Limoges

location_facility: Institut Curie Centre de Lutte Contre le Cancer (CLCC)


title: Treatment Decision Impact of OncotypeDX™ in HR+, N- Breast Cancer Patients

acronym: SWITCH

summary:
Primary objective:

Determine the impact of the Oncotype DX Recurrence Score (RS) on the treatment recommendation made (administration of chemotherapy or not, in addition to hormonotherapy) in a HR+, N- or pN1(mi), Her2- breast cancer adjuvant population.

The impact of Oncotype DX on treatment recommendations can be either a decrease in treatment intensity defined as a change in treatment recommendation from chemotherapy plus hormonal therapy to hormonal therapy alone or an increase in treatment intensity defined as a movement from hormonal therapy alone to the addition of chemotherapy to hormonal therapy.

Patients with HR+, N- breast cancer currently represent around 70% of newly diagnosed breast cancers. These are usually good prognosis tumors. However, on the basis of classical clinical and pathological prognostic parameters and markers, the international consensus guidelines recommend treatment with hormone- and chemotherapy in 85-95% of the cases. Considering the natural disease history, such as documented by the EBCTCG meta-analysis, more than 50% of these patients are overtreated, which leads to unnecessary side effects and costs to the health system and to the society.

Oncotype DX appears to be well adapted to therapeutic de-escalation as it targets HR+, N- patients and is performed on fixed paraffin embedded tissue (FPET). It is therefore best adapted to daily clinical practice as it does not necessitate any specific surgical procedure or tissue freezing.

The prognostic and predictive value of Oncotype DX in ER+, N- patients has been validated on three large adjuvant randomized trials (NASBP B-14, NSABP B-20, and the ATAC study). The test has been commercially available in the USA since 2004, and is being used for more than 50% of the HR+ N- patients in this country.

While Oncotype DX has been validated in the USA, it needs to be independently evaluated in France, in the context of the local treatment guidelines and habits, to provide data that are meaningful to the French health system and to the French medical community.

lead_sponsor: Genomic Health®, Inc.

sponsor_collaborators:
Genomic Health®, Inc.
Registrat-Mapi

location_facility:
Hôpital TENON
CHRU Besançon
Centre Val d'Aurelle
Centre d'Oncologie Médicale de Gentilly
Centre Azuréen de Cancérologie
Centre Jean Perrin


title: A Multi-centre Randomised Controlled Trial to Compare the Effectiveness of Two Rehabilitation Programs in Patients With Multiple Sclerosis.

acronym: REHABMUSCLE

summary: The purpose of this study was to compare the effectiveness of two rehabilitation programs (one month) in patients with multiple sclerosis. The first program is combined with physiotherapy, endurance training and resistance training. The second one is physiotherapy in private practice. Another purpose is to assess the length of the benefits of the combined program.

location_facility: Physical medicine and rehabilation Department, Hôpital RAYMOND POINCARE


title: Evaluation of the Effects of Rehabilitation Using the "Wii" on Upper Limb Kinematics in Chronic Stroke Patients.

acronym: WII

summary: The purpose of this study is to evaluate changes in strategies of hemiparetic upper limb movement in chronic stroke patients following rehabilitation using the "Nintendo Wii". The investigators hypothesize that patients will increase their use of compensatory strategies following this rehabilitation.

ReferenceCitation: Teremetz M, Garcia Alvarez A, Hanneton S, Roby-Brami A, Roche N, Bensmail D, Lindberg P, Robertson JVG. Improving upper-limb and trunk kinematics by interactive gaming in individuals with chronic stroke: A single-blinded RCT. Ann Phys Rehabil Med. 2022 May;65(3):101622. doi: 10.1016/j.rehab.2021.101622. Epub 2022 Feb 26.

oa_colors: green hybrid

evidence: open (via crossref license)

license: publisher-specific-oa

license_normalized: publisher-specific

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

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

unpaywall_oa_status: hybrid


title: Phase Ib Trial of Multiple-ascending Doses of EMD 1201081 in Combination With 5-FU/Cisplatin and Cetuximab in First-line Subjects With Recurrent/ Metastatic Squamous Cell Carcinoma of the Head and Neck

summary: The primary purpose of this trial is to assess the safety and tolerability of EMD 1201081, a novel immunomodulatory agent that is an agonist of TLR9, in combination with 5-FU/cisplatin and cetuximab in first line treatment of patients with recurrent/metastatic squamous cell carcinoma of the head and neck, and to determine the maximum tolerated dose (MTD) among the dose levels.

lead_sponsor: Merck KGaA, Darmstadt, Germany

location_facility: Clinical Research Unit and Pharmacology Lab EA 3035 Institut Claudius Regaud


title: Assessment of Four-dimensional (4D) 18F-fluoro-deoxy-glucose (FDG) Positron Emission Tomography and Computed Tomography System (PET-CT) in Radiotherapy for Non Small Cell Lung Cancers (NSCLC)

acronym: PULMOTEP

summary: Computed tomography (CT) images, used for radiotherapy planning, are often caught out in lung target volumes delineation because of their inability to differentiate between neoplasia, inflammation and atelectasia. Positron Emission Tomography (PET) is a new functional imaging modality and is currently used in the diagnosis and the staging of lung cancers. The aim of this study is to evaluate the impact of 4D 18F-FDG-PET-CT on radiotherapy planning for lung cancers.

lead_sponsor: University Hospital, Bordeaux


type: Other Grant/Funding Number

title: Coagulation Activation Markers and Pre Eclampsia : Correlation With Complications

acronym: PRESTIGE

summary: The primary purpose of the trial is to evaluate coagulation activator markers in patients with pre eclampsia compared to control (normal pregnancy) and to correlate these markers with the severity of the pathology.

lead_sponsor: University Hospital, Lille


title: Low Grade Inflammation in Type 1 Diabetes Children

acronym: Coccinelle

summary: The study propose to measure the inflammation level in type 1 diabetes children with the cytokine analysis compared to non diabetic children of the same sibling and to healthy children.


title: GFAP Auto-immunity : a French Cohort Study

acronym: GFAP

summary:
Glial fibrillary acidic protein (GFAP)-Immunoglobulin G (IgG) have recently been described as a biomarker of a novel inflammatory central nervous system (CNS) disorder, termed autoimmune GFAP astrocytopathy. Thus far, four major clinical series have been published (two from Mayo Clinic USA, one from Italy and one from China). GFAP-IgG detected in serum or in cerebrospinal fluid, by tissue-based assay and confirmed by cell-based assay, are associated with encephalitis or meningoencephalitis of acute or subacute onset, less frequently with myelitis or optic disk edema. The characteristic MRI feature is brain linear perivascular radial gadolinium enhancement in the white matter perpendicular to the ventricle, consistent with the immunohistochemical staining pattern of GFAP in rodent brain sections. Approximately 20% of reported cases are associated with a neoplasm (ovarian teratoma mostly). Coexisting neural autoantibodies are described in some patients, N-methyl-D-aspartate (NMDA)-receptor (R)-IgG mostly, followed by aquaporin 4 (AQP4)-IgG. The disease is usually corticosteroid responsive although relapse can occur. In contrast, Chinese patients display poorer outcomes. Pathophysiology is not well understood but the intracellular antigen location makes GFAP-IgG unlikely pathogenic whereas animal models and neuropathologic data suggest a T-cell immune-mediated disorder.

The aim of the investigators is to report the first French cohort of patients GFAP-IgG positive. Investigators retrospectively assessed clinical, immunological and radiological features, treatment response and outcomes.


title: The Primordial Dwarfisms: Diagnosis, Identification of the Molecular Basis of Seckel Syndrome and Microcephalic Osteodysplastic Primordial Dwarfism Type II (MOPDII).

acronym: NANPIM

summary: The purpose of this study si to define morphological and epidemiological parameters and identify new symptoms in French patients with Seckel syndrome (SCKL) or microcephalic osteodysplastic primordial dwarfism type II (MOPDII).

location_facility: Medical Genetics Department and INSERM U781, Necker-Enfants Malades Hospital


title: Measurement of Glomerular Filtration Rate With Contrast-enhanced Dynamic MR Imaging in Renal Transplant Recipients: Evaluation of the Agreement With the Cr51 -EDTA Method and of Reproducibility

acronym: IREN

summary: The aim of the study is to optimize and validate this MR-based GFR measurement in patients with a renal transplant, compared with the reference method, the Cr51- EDTA method: to select the most accurate combination of post-treatment of renal MR images and then evaluate its intra- and inter-rater reliability.

location_facility: Service d'imagerie Diagnostique et interventionelle de l'adulte, Hôpital Pellegrin, CHU de Bordeaux


title: Double-Blind Placebo-Controlled Study of Subcutaneous Immunotherapy in Birch Pollen Allergic Patients

summary: To compare versus placebo the efficacy and safety of recombinant Bet v1, natural purified Bet v1 and birch pollen licenced extract used for subcutaneous immunotherapy.

lead_sponsor: Stallergenes Greer

intervention_type: Biological


title: Pre-hospital Morphine Titration : Comparison of 0,05 Versus 0,1 mg/kg

summary: Efficacy and safety of morphine titration on acute pain in emergency medical mobile units with initial bolus of 0.1 mg/kg plus 0.05 mg/kg versus morphine titration with initial bolus of 0.05 mg/kg plus 0.025 mg/kg

ReferenceCitation: Ricard-Hibon A, Leroy N, Magne M, Leberre A, Chollet C, Marty J. [Evaluation of acute pain in prehospital medicine]. Ann Fr Anesth Reanim. 1997;16(8):945-9. doi: 10.1016/s0750-7658(97)82142-9. French.

ReferenceCitation: Ricard-Hibon A, Marty J. Prise en charge de la douleur en milieu préhospitalier, In SFAR, Conférences d'actualisation 2001, Paris, Elsevier,2001;pp 709-22

ReferenceCitation: SFAR. Quelles sont les modalités de réalisation d'une sédation et/ou d'une analgésie du malade en ventilation spontanée. In : SFAR eds. Modalités de la sédation et/ou de l'analgésie en situation extrahospitalière : Conférence d'experts. Paris, Elsevier;2000;pp 37-51

ReferenceCitation: SFUM. Troisième conférence de consensus en médecine d'urgence de la Société francophone d'urgence médicale. Le traitement médicamenteux de la douleur de l'adulte dans un service d'accueil et d'urgence. Réan Urg 1993; 2:321-7

ReferenceType: result

ReferenceCitation: Bounes V, Charpentier S, Houze-Cerfon CH, Bellard C, Ducasse JL. Is there an ideal morphine dose for prehospital treatment of severe acute pain? A randomized, double-blind comparison of 2 doses. Am J Emerg Med. 2008 Feb;26(2):148-54. doi: 10.1016/j.ajem.2007.04.020.

lead_sponsor: University Hospital, Toulouse


title: Blood Activation During Cardiopulmonary Bypass Using Roller or Centrifugal Pumps

summary: Blood activation induced by cardiopulmonary bypass may compromise the postoperative outcome. The goal of this study is to compare blood activation induced by cardiopulmonary bypass performed with centrifugal pump or roller pump in patients undergoing coronary artery surgery.

lead_sponsor: University Hospital, Angers


title: National Study on the Quality of Life of Patients With Anorectal Malformation (MARQOL)

acronym: MARQOL

summary:
Anorectal malformations, occurring approximately 1 in 5000 live births, mainly involve the distal anus and rectum, but also sometimes the urinary and genital tracts. Defects range from the minor and easily treated with an excellent functional prognosis, to those that are complex and often associated with a poor functional prognosis.

Despite the better knowledge of the anatomy and physiology and the improvement of surgical management after birth, fecal and urinary incontinence can occur, due mainly to deficient nerve supply.

The quality of life of such patients is largely unknown in this country. The aim of the investigators study is to propose specific and generic questionnaires to the patients registered in the national database, correlated to their anatomical and functional status. A better understanding of such correlations should allow improvements in their medical and social management.

ReferenceCitation: Clermidi P, Podevin G, Cretolle C, Sarnacki S, Hardouin JB. The challenge of measuring quality of life in children with Hirschsprung's disease or anorectal malformation. J Pediatr Surg. 2013 Oct;48(10):2118-27. doi: 10.1016/j.jpedsurg.2013.03.071.

ReferenceCitation: Mantoo S, Meurette G, Wyart V, Hardouin J, Cretolle C, Capito C, Sarnacki S, Podevin G, Lehur PA. The impact of anorectal malformations on anorectal function and social integration in adulthood: report from a national database. Colorectal Dis. 2013 Jun;15(6):e330-5. doi: 10.1111/codi.12186.

ReferenceCitation: Podevin G, Petit T, Mure PY, Gelas T, Demarche M, Allal H, Becmeur F, Varlet F, Philippe P, Weil D, Heloury Y. Minimally invasive surgery for anorectal malformation in boys: a multicenter study. J Laparoendosc Adv Surg Tech A. 2009 Apr;19 Suppl 1:S233-5. doi: 10.1089/lap.2008.0137.supp.

ReferenceCitation: Fleury J, Picherot G, Cretolle C, Podevin G, David A, Caillon J, Roze JC, Gras-le Guen C. Currarino syndrome as an etiology of a neonatal Escherichia coli meningitis. J Perinatol. 2007 Sep;27(9):589-91. doi: 10.1038/sj.jp.7211783.

lead_sponsor: Nantes University Hospital

collaborators: MAREP ( Center For Rare Diseases Center Ano-Rectal And Pelvic Abnormalities)

location_facility:
CHU Toulouse
CHU Pointe-à-Pitre
AP-HM Hôpital Nord
CHU Nice
CHU Rennes
CHU Brest
CHU Limoges
CHU Amiens
CHR Orléans
CHRU Strasbourg
CHU Dijon
CHU Rouen
CHRU Tours
CHU de Nantes
CHR La Réunion
CHU Nancy
CHU Angers
AP-HP Hôpital Trousseau
CH Le Mans
Hôpitaux Civils de Colmar
AP-HP Hôpital Necker
CHU Montpellier
CHU Reims
CHU Clermont-Ferrand
CHU Saint Etienne
CHRU Lille
CHU Caen
CHU Fort-de-France
AP-HP Hôpital Bicêtre
CHU Grenoble
AP-HP Hôpital Robert Debré
CH Saint Brieuc
CHU Besançon
AP-HM La Timone
Hospices Civils de Lyon
CHU Poitiers
CHU Bordeaux