title: Evaluation of the Efficacy of a Mobile Phone Short Message Service on Post-fracture Management for Patients Who Consult to the Emergency Department

acronym: Ostéo-SMS

summary: The purpose of the study is to show that the standardized sending of SMS improve the bone mineral density (BMD) screening of patients seen in the Emergency department for low trauma fracture.


title: Early Non Invasive Ventilation in Immuno-compromized Patients With Acute Respiratory Failure. A Prospective Randomized Clinical Trial.

acronym: IVNICTUS

summary: Assess the superiority of early non invasive ventilation in comparison to Oxygen therapy only, for immuno-compromized patients with acute respiratory failure

status: Completed

study_completion_date_type: Actual

study_type: Interventional

design_allocation: Randomized

primary_purpose: Treatment

enrollment_type: Actual

ReferenceType: background

ReferenceCitation: Lemiale V, Resche-Rigon M, Azoulay E; Study Group for Respiratory Intensive Care in Malignancies Groupe de Recherche en Réanimation Respiratoire du patient d'Onco-Hématologie. Early non-invasive ventilation for acute respiratory failure in immunocompromised patients (IVNIctus): study protocol for a multicenter randomized controlled trial. Trials. 2014 Sep 25;15:372. doi: 10.1186/1745-6215-15-372.

ReferenceType: result

ReferenceCitation: Lemiale V, Mokart D, Resche-Rigon M, Pène F, Mayaux J, Faucher E, Nyunga M, Girault C, Perez P, Guitton C, Ekpe K, Kouatchet A, Théodose I, Benoit D, Canet E, Barbier F, Rabbat A, Bruneel F, Vincent F, Klouche K, Loay K, Mariotte E, Bouadma L, Moreau AS, Seguin A, Meert AP, Reignier J, Papazian L, Mehzari I, Cohen Y, Schenck M, Hamidfar R, Darmon M, Demoule A, Chevret S, Azoulay E; Groupe de Recherche en Réanimation Respiratoire du patient d'Onco-Hématologie (GRRR-OH). Effect of Noninvasive Ventilation vs Oxygen Therapy on Mortality Among Immunocompromised Patients With Acute Respiratory Failure: A Randomized Clinical Trial. JAMA. 2015 Oct 27;314(16):1711-9. doi: 10.1001/jama.2015.12402.

name: Saint-Louis University Hospital, Paris, France

family: Lemiale

full_name: Virginie Lemiale

given: Virginie

sequence: first

family: Mokart

full_name: Djamel Mokart

given: Djamel

sequence: additional

family: Resche-Rigon

full_name: Matthieu Resche-Rigon

given: Matthieu

family: Pène

full_name: Frédéric Pène

given: Frédéric

name: Service de Pneumologie Et Réanimation Médicale, AP-HP, Groupe Hospitalier Pitié-Salpêtrière Charles Foix, Paris, France

family: Mayaux

full_name: Julien Mayaux

given: Julien

family: Faucher

full_name: Etienne Faucher

given: Etienne

family: Nyunga

full_name: Martine Nyunga

given: Martine

name: Medical Intensive Care Unit, Charles Nicolle University Hospital-Rouen University, Rouen, France

family: Girault

full_name: Christophe Girault

given: Christophe

name: Centre Hospitalier Universitaire-Nancy, Nancy, France

family: Perez

full_name: Pierre Perez

given: Pierre

name: University Hospital of Nantes, Nantes, France

family: Guitton

full_name: Christophe Guitton

name: The Institut Gustave-Roussy (IGR), France

family: Ekpe

full_name: Kenneth Ekpe

given: Kenneth

name: Intensive Care Unit, CHRU Angers, Angers, France

family: Kouatchet

full_name: Achille Kouatchet

given: Achille

family: Théodose

full_name: Igor Théodose

given: Igor

name: Intensive Care Medicine, Ghent, Gent, Belgium

family: Benoit

full_name: Dominique Benoit

given: Dominique

family: Canet

full_name: Emmanuel Canet

given: Emmanuel

name: Medical Intensive Care Unit, La Source Hospital-CHR Orleans, Orléans, France

family: Barbier

full_name: François Barbier

given: François

family: Rabbat

full_name: Antoine Rabbat

given: Antoine

name: Intensive Care Unit, Hopital Andre Mignot-Le Chesnay, Paris, France

family: Bruneel

full_name: Fabrice Bruneel

given: Fabrice

name: Hôpital d'Avicenne, APHP, Bobigny, France

family: Vincent

full_name: Francois Vincent

given: Francois

name: Lapeyronie University Hospital, Montpellier, France

family: Klouche

full_name: Kada Klouche

given: Kada

name: Centre Hospitalier Universitaire-Amiens, Amiens, France

family: Loay

full_name: Kontar Loay

given: Kontar

family: Mariotte

full_name: Eric Mariotte

given: Eric

family: Bouadma

full_name: Lila Bouadma

given: Lila

name: Centre de Réanimation, CHRU Lille, Lille, France

name: Centre Hospitalier Universitaire-Caen, Caen, France

name: Institut Jules Bordet, Brussels, Belgium

name: Réanimation Médicale, Centre Hospitalier Universitaire-Nantes, Nantes, France

name: Réanimation DRIS, Hopital Nord, Marseille, France

name: Centre Hospitalier Sud Francilien (CHSF), France

name: The Hôpital civil de Strasbourg, Strasbourg, France

name: The Centre Hospitalier Universitaire de Grenoble, Grenoble, France

name: Medical-Surgical ICU, Saint-Etienne University Hospital, Saint-Etienne, France


title: Impact de la Transfusion de Culots Globulaires de Moins de 14 Jours Sur la Morbi-mortalité Chez Des Patients en Chirurgie Cardiaque

acronym: CGRCard

summary:
The purpose of the transfusion of packed red blood cell is to overcome acute or chronic anemia cause tissue hypoxia. It increases hemoglobin concentration and consequently increase oxygen delivery to peripheral tissues. The perioperative period of major surgery is a field particularly favorable to the development of tissue hypoxia, which is associated with increased mortality and postoperative morbidity. Optimization of oxygen transport to tissues at the preoperative period is accompanied by a significant reduction of these major complications.

Clinical complications (infectious or otherwise) related to transfusion of caps Red Blood cells Caps (RBC)are well known. Many studies seem to evidence the potentially deleterious effect of transfusion, especially in patients with poor condition, related to storage time. Indeed, during storage, impaired blood-related storage is created. It is metabolic, biochemical and molecular levels. Many studies, carried out in particular in cardiac surgery where patients are suitable for transfusion RBC, have focused on the effect of transfusions on consumption and the transport of oxygen to demonstrate the impact of conservation lesions on their role in vivo. In particular, a single-center retrospective American study showed reduction of postoperative complications in patients who received RBC under 14 days.

However one of the confounding factors present is that all transfused RBCs are not leukoreduced (unlike the French transfusion policy). In addition, the greater part of the clinical studies are controversial. That is why we aim to assess, through a retrospective study of data, the impact of transfusion of red red blood cells within 14 days of post-operative morbidity and mortality, compared to the usual transfusion practice in cardiac surgery patients.

status: Terminated

study_type: Observational

time_perspective: Retrospective

lead_sponsor: Centre Hospitalier Universitaire de Besancon

location_facility: Centre Hospitalier Universitaire de Besançon

intervention_type: Procedure

lead_sponsor_type: academique

status_simplified: Unknown


type: Other Identifier

title: Micro Array Analysis in Preeclampsia

summary:
Preeclampsia is a frequent pathology. His etiology is doubtful.

Targets :

The study target is to identify a risk of preeclampsia group obtained with transcriptom analysis from circulating peripheric cells.

Design:

Multidisciplinary study (Gynaecology-Obstetric, Immunology, North CIC).

The study of the transcriptional history of peripheral blood cells of 2patients groups:

A patient group with a preeclampsia before 34 SA
A patient group with a normal pregnancy paired on main confusion factors. Blood sampling will be collected at the diagnosis and 8 weeks after delivery.

Results and perspectives

Obtain a transcriptionnal signature of preeclampsia
To identify new mechanism of the disease
Identification of a specific transcriptom analysis with the comparison after delivery For long-term, the target is to identify risk patient in order to conduct easily preventive clinical trials in preeclamsia (primary prevention) and to consider a specific follow-up for risk patients.

study_start_date_type: Actual

status: Recruiting

study_completion_date_type: Anticipated

design_allocation: Non-Randomized

primary_purpose: Other

enrollment_type: Anticipated

lead_sponsor: Assistance Publique Hopitaux De Marseille

location_facility: Assistance Publique Hopitaux de Marseille

intervention_type: Other

status_simplified: Ongoing


type: EudraCT Number

title: A Phase I Randomized, Open-label, 3-arm Parallel-design Study to Determine the Effect of Multiple-dose Gemfibrozil or Itraconazole on the Pharmacokinetics, Safety and Tolerability of Single-dose MDV3100 (ASP9785) in Healthy Male Subjects

summary: A study to assess possible drug-drug interactions between MDV3100 and gemfibrozil and MDV3100 and Itraconazole.

ReferenceType: derived

ReferenceCitation: Gibbons JA, de Vries M, Krauwinkel W, Ohtsu Y, Noukens J, van der Walt JS, Mol R, Mordenti J, Ouatas T. Pharmacokinetic Drug Interaction Studies with Enzalutamide. Clin Pharmacokinet. 2015 Oct;54(10):1057-69. doi: 10.1007/s40262-015-0283-1.

family: Gibbons

full_name: Jacqueline A. Gibbons

given: Jacqueline A.

family: de Vries

full_name: Michiel de Vries

given: Michiel

family: Krauwinkel

full_name: Walter Krauwinkel

given: Walter

family: Ohtsu

full_name: Yoshiaki Ohtsu

given: Yoshiaki

family: Noukens

full_name: Jan Noukens

given: Jan

family: van der Walt

full_name: Jan-Stefan van der Walt

given: Jan-Stefan

family: Mol

full_name: Roelof Mol

given: Roelof

family: Mordenti

full_name: Joyce Mordenti

given: Joyce

family: Ouatas

full_name: Taoufik Ouatas

given: Taoufik

bso_classification: Medical research

datasource: user

genre: journal-article

genre_raw: journal-article

journal_name: Clinical Pharmacokinetics

oa_colors: green hybrid

oa_host_type: publisher;repository

evidence: open (via page says license)

host_type: publisher

license: cc-by-nc

license_normalized: cc-by-nc

version: publishedVersion

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

host_type: repository

repository_institution: PubMed Central - Europe PMC

repository_normalized: PubMed Central

evidence: oa repository (via pmcid lookup)

license_normalized: no license

publisher: Springer Science and Business Media LLC

publisher_dissemination: Springer-Nature

publisher_group: Springer-Nature

publisher_normalized: Springer

lead_sponsor: Astellas Pharma Europe B.V.

intervention_type: Drug

lead_sponsor_type: industriel

status_simplified: Completed


title: Endoscopic Sub-mucosal Dissection With the Nestis® Jet Injector System With a Bi-functional Catheter: First Prospective Trial.

acronym: NESTIS

summary: ESD (Endoscopic Sub-mucosal Dissection)is the first-intent method to treat superficial neoplasms of the digestive tract at it allows an en-bloc R0 resection. Following marking of the lesion margins, ESD comprises 3 steps: 1) liquid injection into the sub-mucosal space 2) circumferential (complete or partial) incision and 3) dissection of the submucosa. Several tools are necessary to perform ESD with the standard technique. Development of water jet with bi functional (injection and cutting) catheter allows time and significant reduction of perforation risk (due to multiple changes of instruments). For this purpose, Nestis introduced the Enki 2 pulsed jet technology with high pressure system to inject efficiently and at any time viscous solutions in direct viewing and retroflexion. Preliminary pig studies indicate that injection of glycerol, hyaluronate and hydroxyethlstarch with Enki 2 are possible. In addition, preclinical studies on living pig colon models using saline solutions have demonstrated that perforation rates and operating times are significantly reduced compared to a standard electrosurgical knife. The present clinical study is being performed to confirm this system capability to perform ESD in humans.

ReferenceCitation: Pioche M, Lépilliez V, Ciocîrlan M, Rivory J, Miaglia C, Hervieu V, Poncet G, Valette PJ, Saurin JC, Ponchon T. Endoscopic submucosal dissection with the Nestis(®) jet injector system with a bifunctional catheter: first prospective clinical trial (NCT: 2012-A00272-41). Surg Endosc. 2016 Nov;30(11):5140-5146. Epub 2016 Mar 4.

lead_sponsor: Hospices Civils de Lyon

intervention_type: Device


title: Nutritional Adaptation to Contemporary Sedentary Behaviors and Physical Exercise in Youth: Effect of Weight Status

summary: Sedentary behaviors have been shown to increase food consumption among youth and adults. The recent active video games devices have been suggested to compensate for the increased energy intake they induce by the increased energy expenditure they generate. To date no study has been conducted to question whether or not such modern sedentary activities induce energy consumption modification in youth. The aim of this work is to compare the impact of a passive video games vs. active video games vs. physical exercise in terms of subsequent energy intake and appetite feelings in normal weight and obese youth.

status: Withdrawn

lead_sponsor: Université Blaise Pascal, Clermont-Ferrand

intervention_type: Behavioral


title: Assessment of Quality of Global and Sexual Life and Impact of Surgical and Non Surgical Vaginal Aplasia in Patients With a Rokitansky Syndrome

acronym: MRKH

summary:
The principal objective is to assess the general health status and the sexual health status of women with Rokitansky syndrome having received a surgical or non surgical treatment.

The secondary purpose is to assess the anatomical aspect and the quality of sexual life. To search a correlation between the anatomical result, the general and sexual quality of life. To compare the different techniques of medical follow-up in terms of anatomic results, general quality of life, sexual quality of life, complications and morbidities.

To evaluate social inclusion of these women with their family situation, social and professional category and their job.

At the same time, we propose an evaluation with a psychologist to study the impact of the announcement of the diagnosis. This impact study is conducted at a distance from diagnosis.

ReferenceCitation: Cheikhelard A, Bidet M, Baptiste A, Viaud M, Fagot C, Khen-Dunlop N, Louis-Sylvestre C, Sarnacki S, Touraine P, Elie C, Aigrain Y, Polak M; French MRKH Study Group. Surgery is not superior to dilation for the management of vaginal agenesis in Mayer-Rokitansky-Küster-Hauser syndrome: a multicenter comparative observational study in 131 patients. Am J Obstet Gynecol. 2018 Sep;219(3):281.e1-281.e9. doi: 10.1016/j.ajog.2018.07.015. Epub 2018 Jul 21.

family: Cheikhelard

full_name: Alaa Cheikhelard

given: Alaa

family: Bidet

full_name: Maud Bidet

given: Maud

family: Baptiste

full_name: Amandine Baptiste

given: Amandine

family: Viaud

full_name: Magali Viaud

given: Magali

family: Fagot

full_name: Christine Fagot

given: Christine

family: Khen-Dunlop

full_name: Naziha Khen-Dunlop

given: Naziha

family: Louis-Sylvestre

full_name: Christine Louis-Sylvestre

family: Sarnacki

full_name: Sabine Sarnacki

given: Sabine

family: Touraine

full_name: Philippe Touraine

given: Philippe

family: Elie

full_name: Caroline Elie

given: Caroline

family: Aigrain

full_name: Yves Aigrain

given: Yves

family: Polak

full_name: Michel Polak

given: Michel

family: Brun

full_name: Jean-Luc Brun

given: Jean-Luc

family: Darai

full_name: Emile Darai

given: Emile

family: Descamps

full_name: Philippe Descamps

family: Gueniche

full_name: Karinne Gueniche

given: Karinne

family: Leguevaque

full_name: Pierre Leguevaque

given: Pierre

family: Lopes

full_name: Patrice Lopes

given: Patrice

family: Louis-Borrione

full_name: Claude Louis-Borrione

given: Claude

family: Morcel

full_name: Karine Morcel

given: Karine

family: Ouallouche

full_name: Chloe Ouallouche

given: Chloe

family: Paniel

full_name: Bernard-Jean Paniel

given: Bernard-Jean

family: Ranke

full_name: Aline Ranke

given: Aline

journal_name: American Journal of Obstetrics and Gynecology

location_facility: Service d'Endocrinologie et Gynécologie Pédiatriques Hôpital Necker Enfants Malades


title: Multicenter Observational Study on Myocardial Iron Overload in 3 Multitransfused Populations

acronym: SUFEMYO

summary: The investigators' primary objective is to study prevalences of myocardial iron overload, defined as a cardiac T2*< 20 ms, in 3 populations of multiply transfused patients, affected with thalassemia, sickle cell disease, and myelodysplasia.

time_perspective: Prospective

lead_sponsor: Assistance Publique - Hôpitaux de Paris

intervention_type: Biological


title: TRESTIS: Multicentric Study With a Curative Endoscopic Treatment of Superficial Neoplasia of a Digestive Tract by Endoscopic Submucosal Dissection: Evaluation of a New Water Jet System Injecting Glycerol Mix

summary: safety evaluation of endoscopic sub-mucosal dissection with nestis enki2 system. This system is a new water jet system which allows to perform Endoscopic submucosal dissection with a bifunctional catheter (injection and cutting).

lead_sponsor: Hôpital Edouard Herriot


type: Other Grant/Funding Number

title: Learning Mechanisms of Food Preferences in 2-3 y. o. Toddlers in Nurseries

summary: The aim of this study is to understand the formation of food preferences from an early age.

lead_sponsor: Centre des Sciences du Goût et de l'Alimentation


summary: To evaluate response rate of cisplatin - metronomic cyclophosphamide treatment.

lead_sponsor: Centre Jean Perrin


summary: Study assessing efficacy of a Cisplatine- Métronomic cyclophosphamide treatment in Patients with Metastatic Triple Negative breast Cancer Secondary Resistant to Anthracyclines and Taxanes.


title: Comparative Study of Dual Yellow Laser Versus Stabilized Kilnman Preparation in the Treatment of Melasma

summary:
Recent data highlight the role of vascularity in melasma and a recent study showed the interest to target this vascular component by pulsed dye laser. The Dual Yellow laser is a copper bromide laser emitting dual wavelength (green 511nm and yellow 578 nm). This laser can target both the vascular and pigmented components of melasma. A preliminary study has shown its efficacy and excellent tolerability in the treatment of melasma. This study requires however to be confirmed by a comparative study versus reference treatment.

Main objective To compare the efficacy on melasma at 6 month post treatment of a Dual Yellow Laser preceded by 1 month of kilnman trio and the kilnman trio monotherapy for 3 months in an intra-patient study.

Secondary objectives

To study the frequency of PPI.
Compare the rate and extent of recurrence 6 months after completion of treatment.
To study the occurrence of possible adverse effects.
Compare the effectiveness of Dual Yellow laser to kilnman trio monotherapy at S12 (end of treatment).
To study patient satisfaction on the effectiveness and tolerability of the study treatments.

Methods Monocentric prospective interventional randomized split face comparative study between experimental treatment versus reference treatment.

Intervention

Visit Selection Patients will be selected from those presenting to the consultation of the department of dermatology at University Hospital of Nice. Participation will be offered to patients corresponding to the selection criteria of the study.

Visit V0: Inclusion and early treatment After a minimum of 15 days, patients will begin the study. This will ensure that patients signed informed consent. An initial clinical evaluation of melasma with calculation of MASI score and standardized photographs (see chapter 'assessment') will be made. An examination by confocal microscopy in vivo will be realized. All patients will receive treatment by stabilized kilnman trio for four weeks.

In the week prior to Visit 1, the side of the face to receive the laser treatment will be determined by randomisation.

Visit V1: (Week 4) Clinical evaluation of melasma with calculation of MASI score and photographs will be made. Possible side effects (including PPI) will be noted.

The next trio will be treated with depigmenting kilnman trio for another 8 weeks. The contralateral side will receive its first laser session. Given the results of analysis by intention to treat, the occurrence of serious side effects will result in discontinuation of treatment but monitoring will continue with the assessments.

Visit V2: (week 6) Clinical evaluation of melasma with calculation of MASI score and photographs will be made. Possible side effects (including PPI) will be noted.

The laser side will receive its second session. Patients continue the applications of cream on the contralateral side.

Visit V3 (week 9) Clinical evaluation of melasma with calculation of MASI score and photographs will be made. Possible side effects (including PPI) will be noted.

The laser side will receive its third session.Patients continue the applications of cream on the contralateral side.

Visit V4 (week 12) Clinical evaluation of melasma with calculation of MASI score and photographs will be made. Possible side effects (including PPI) will be noted.

The laser side will receive its fourth and final session. Patients continue the applications of cream on the contralateral side during 4 weeks.

Visit V5: (week 18) Clinical evaluation of melasma with calculation of MASI score and photographs will be made. Possible side effects (including PPI) will be noted. An assessment by in vivo confocal laser will be realized.
Visit V6: (week 24) Clinical evaluation of melasma with calculation of MASI score and photographs will be made. Possible side effects (including PPI) will be noted. An assessment by in vivo confocal laser will be realized.
Visit V7 (final week 36):

Clinical evaluation of melasma with calculation of MASI score and photographs will be made. Possible side effects (including PPI) will be noted. An assessment by in vivo confocal laser will be realized. The evaluation of safety and patient satisfaction will be performed using a visual analog scale.

The primary endpoint will be the MASI score, score approved for assessment of melasma treatments.

ReferenceCitation: Hammami Ghorbel H, Boukari F, Fontas E, Montaudié H, Bahadoran P, Lacour JP, Passeron T. Copper Bromide Laser vs Triple-Combination Cream for the Treatment of Melasma: A Randomized Clinical Trial. JAMA Dermatol. 2015 Jul;151(7):791-2. doi: 10.1001/jamadermatol.2014.5580.

family: Hammami Ghorbel

full_name: Houda Hammami Ghorbel

given: Houda

family: Boukari

full_name: Fériel Boukari

given: Fériel

name: Délégation à la Recherche Clinique et à l’Innovation, University Hospital of Nice, Nice, France

family: Fontas

full_name: Eric Fontas

given: Eric

family: Montaudié

full_name: Henri Montaudié

given: Henri

family: Bahadoran

full_name: Philippe Bahadoran

family: Lacour

full_name: Jean-Philippe Lacour

given: Jean-Philippe

name: Department of Dermatology, University Hospital of Nice, Nice, France3INSERM U1065, Team 12, C3M, Nice, France

family: Passeron

full_name: Thierry Passeron

given: Thierry

journal_name: JAMA Dermatology

oa_host_type: publisher

evidence: open (via free pdf)

publisher: American Medical Association (AMA)

publisher_dissemination: American Medical Association

publisher_group: American Medical Association

publisher_normalized: American Medical Association

lead_sponsor: Centre Hospitalier Universitaire de Nice


title: Reduced Intensity Conditioning Allogeneic Transplantation for CLL With Preemptive MDR Management (ICLL 03 RICAC-PMM)

acronym: RICAC

summary: Usually Chronic lymphocytic leukemia (CLL) is a disease of the elderly patients. However, the diagnosis in young patients become more frequently with poor prognosis. The identification of new prognostic factors permits early determination of the high risk population and provide them the therapeutic intensification. Allogeneic transplantation of hematopoietic stem cells transplantation (AHSCT) allows to long-term remission and in some cases complete and definitive eradication of the disease. After chemotherapy or antibodies, the Minimal Residual Disease (MRD) negativity is associated with better disease-free survival. MRD negativity occurs in some patients with the appearance of GVHD, stopping the immunosuppression or after donor lymphocyte injection (DLI). The negativity of MRD in the first year post-transplant is correlated with better progression-free survival or overall survival (Dreger 2010, Farina 2009, Caballero 2005, Algrin, 2011). So, MRD negativity may be an objective after AHSCT. The aim of this prospective study is to evaluate a standardized preemptive immunointervention of post-allograft immunosuppressive therapy modulation and DLI administration according to MRD level. The objective is to obtain MRD negativity at 12 months after AHSCT.

status: Unknown status

lead_sponsor: University Hospital, Clermont-Ferrand


title: Anatomical Clinical Correlations. Neuropsychological and Brain Medical Imaging Study in Brain Damaged Subjects.

acronym: CORAC

summary:
Two groups of subjects will be constitute: (i) patients with circumscribed brain injury (including stroke, vascular malformations, tumor or circumscribed infectious lesions) or degenerative disorders and selective cognitive disorders; (ii) healthy control subjects.

The objective of this project is to evaluate specific neuropsychological deficits and apply current brain imaging techniques (anatomical, diffusion, functional) to patients suffering from these cognitive deficits due to brain damage, in order to elucidate the brain mechanisms underlying these deficits.

primary_purpose: Diagnostic

lead_sponsor: University Hospital, Rouen


title: Peut-on améliorer la Marche de l'amputé fémoral en Guidant la Correction prothétique Par l'Analyse Des Pressions Dans l'emboîture ?

summary:
This study aims at evaluating the relation between quality of the interface between the stump and the prosthesis, and the quality of gait in above-knee amputees.

The hypothesis is that an adapted prosthesis allowing an efficient gait in above-knee amputees corresponds to an homogeneous pressure distribution pattern onto the stump.

lead_sponsor: University Hospital, Grenoble


title: Impact of Adding a Limitation Section in Abstract of Systematic Review on Interpretation by Readers: a Randomised Controlled Trial

acronym: ILMARI 2

summary:
Objective: The investigators aim to evaluate the impact of a adding a " limitations " section in systematic review's abstract on result's interpretation by readers Design: randomized controlled trial with two parallel arms. Participants will be invited to participate in an online survey.

Participants: Eligible participants are corresponding authors of clinical trials published between 2010 and 2012 and referenced in Medline.

Intervention: The investigators will evaluate the impact of the presence of a " limitations " section in abstract of systematic review with meta- analysis. The investigators selected abstracts of meta-analysis from a sample.

Selected abstract will be standardised and the treatment's name hidden. Two groups of abstract will be presented as follow: 1) abstract without " limitations " section 2) abstract with " limitations " section. The " limitations " section will be written by authors and will briefly describe the risk of bias of included studies.

Selected participant are invited by e-mail to answer the survey. After reading one abstract from his/her group of randomisation they are invited to answer 5 questions about their interpretation of the results.

ReferenceCitation: Yavchitz A, Ravaud P, Hopewell S, Baron G, Boutron I. Impact of adding a limitations section to abstracts of systematic reviews on readers' interpretation: a randomized controlled trial. BMC Med Res Methodol. 2014 Nov 24;14:123. doi: 10.1186/1471-2288-14-123.

family: Yavchitz

full_name: Amélie Yavchitz

given: Amélie

family: Ravaud

full_name: Philippe Ravaud

given: Philippe

family: Hopewell

full_name: Sally Hopewell

given: Sally

family: Baron

full_name: Gabriel Baron

given: Gabriel

family: Boutron

full_name: Isabelle Boutron

given: Isabelle

currency_apc_doaj: GBP

journal_name: BMC Medical Research Methodology

oa_colors: green gold

evidence: oa journal (via doaj)

license: cc-by

license_normalized: cc-by

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

repository_institution: Columbia University - Columbia Academic Commons

repository_institution: University of Oxford - Oxford University Research Archive (ORA)

publisher_dissemination: Springer

publisher_group: Springer

title: Impact of adding a limitations section to abstracts of systematic reviews on readers’ interpretation: a randomized controlled trial


title: Impact of "Spin" on the Interpretation of Results of Randomized Trials in the Field of Cancer

acronym: SPIIN

summary:
1Randomized controlled trials (RCT) are the gold standard for therapeutic evaluation. Rapid dissemination of trial results and their translation into clinical practice is particularly important. Abstracts published or presented in conferences are a large, rapid and free method to disseminate these results. However, this mode of dissemination may have serious consequences for patients if abstracts are not an accurate and unbiased reflection of the trial results. Indeed, investigators have great freedom when writing their abstracts and articles. They can choose the data to present and decide how to present them. Consequently, they have many opportunities to shape readers' impressions of their results, that is, to add "spin" (ie, spin is a specific way of reporting to convince readers that the beneficial effect (efficacy, safety) of the experimental treatment is higher than shown by the results).

Objective: To assess the impact of spin on the interpretation of results in abstracts of randomized controlled trials with nonstatistically significant results in the field of cancer.

Design: The investigators performed a RCT comparing the interpretation of results in abstracts a) with and b) without spin.

Identification of abstracts of randomized trials with spin. The investigators selected a sample of negative published RCTs (i.e. non statistically significant results) with a spin in abstract conclusion identified in previous works. Inclusion criteria were 1) RCTs with non statistically significant primary outcome, 2) spin in the abstract conclusion.
Abstracts' modification Selected abstracts were systematically rewritten to contain no "spin". All abstracts were presented in the same format without the names of authors, references, or the name of the journal in which it was published, and the names of treatments were masked by using generic terms (e.g., treatment A, comparator B). All abstracts had the same number of words +/-20
Assessment Abstracts were assessed by corresponding authors of randomized trials, experts of specific grants and investigator of trials registered in clinicaltrials.gov. Experts were invited to participate in our study. They were not informed of the objectives of our study. Each clinician were randomized to evaluate 1 abstracts with or 1 abstracts without spin.
The primary endpoint was the interpretation of abstract results by the participants. All readers participating in the study evaluated the abstract of randomized trial and answered the following question: Based on this abstract, do you think treatment A would be beneficial to patients? (answer: numerical scale from 0-10)


title: Trial of Acupuncture Pelvic and Low Back Pain in Pregnancy (TAPPP)

acronym: GAME

summary: Pelvic girdle and low back pain are common in pregnancy, and cause severe impairment in 10% of women. Our hypothesis is that offering acupuncture in addition to standard care would reduce pain and impairment throughout pregnancy. 300 pregnant women from 5 maternity units will be randomized over a 3 year period to receive standard care or standard care plus acupuncture. Main outcome will be the number of days during pregnancy with maximum pain ≤ 4/10. Secondary outcomes will compare groups for an impairment score and for direct and indirect costs.

ReferenceCitation: Nicolian S, Butel T, Gambotti L, Durand M, Filipovic-Pierucci A, Mallet A, Kone M, Durand-Zaleski I, Dommergues M. Cost-effectiveness of acupuncture versus standard care for pelvic and low back pain in pregnancy: A randomized controlled trial. PLoS One. 2019 Apr 22;14(4):e0214195. doi: 10.1371/journal.pone.0214195. eCollection 2019.

family: Nicolian

full_name: Stephanie Nicolian

given: Stephanie

family: Butel

full_name: Thibault Butel

given: Thibault

family: Gambotti

full_name: Laetitia Gambotti

given: Laetitia

family: Durand

full_name: Manon Durand

given: Manon

family: Filipovic-Pierucci

full_name: Antoine Filipovic-Pierucci

given: Antoine

family: Mallet

full_name: Alain Mallet

given: Alain

family: Kone

full_name: Mamadou Kone

given: Mamadou

family: Durand-Zaleski

full_name: Isabelle Durand-Zaleski

family: Dommergues

full_name: Marc Dommergues

given: Marc

currency_apc_doaj: USD

journal_name: PLOS ONE

repository_institution: RePEc: Research Papers in Economics - RePEc

repository_normalized: RePEc

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

repository_normalized: HAL

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

evidence: oa repository (semantic scholar lookup)

version: submittedVersion

repositories:
HAL
PubMed Central
RePEc
pdfs.semanticscholar.org

repositories_pmh: HAL RePEc europepmc.org

publisher: Public Library of Science (PLoS)

publisher_dissemination: Public Library of Science

publisher_group: Public Library of Science

publisher_normalized: Public Library of Science

location_facility: Centre d'Investigation Clinique Paris Est - Hôpital Pitié Salpêtrière


title: Satisfaction Understanding of Patients and Relatives in Emergency Room

summary:
Evaluation of global understanding and with items of patients admitted to the emergency.

Prospective observational study randomized in cluster during 6 weeks in 14 centers

primary_purpose: Health Services Research


title: A Telemedicine System for the Follow-up of Patients With SAS

summary: Objective: Set up an interoperable telemedicine system for the follow-up of patients with sleep apnea syndrome.

location_facility: Assistance Publique - Hôpitaux de Paris, Béclère Hospital


title: Conception of an ICF Core Set for Systemic Sclerosis

acronym: SCISCIF

summary: The purpose of this study is to create and validate an ICF core Set for Systemic sclerosis

ReferenceCitation: Cieza A, Geyh S, Chatterji S, Kostanjsek N, Ustün B, Stucki G. ICF linking rules: an update based on lessons learned. J Rehabil Med. 2005 Jul;37(4):212-8.

ReferenceCitation: Cieza A, Geyh S, Chatterji S, Kostanjsek N, Ustün BT, Stucki G. Identification of candidate categories of the International Classification of Functioning Disability and Health (ICF) for a Generic ICF Core Set based on regression modelling. BMC Med Res Methodol. 2006 Jul 27;6:36.

ReferenceCitation: Clements PJ. Systemic sclerosis (scleroderma) and related disorders: clinical aspects. Baillieres Best Pract Res Clin Rheumatol. 2000 Mar;14(1):1-16. Review.

ReferenceCitation: Coenen M, Cieza A, Stamm TA, Amann E, Kollerits B, Stucki G. Validation of the International Classification of Functioning, Disability and Health (ICF) Core Set for rheumatoid arthritis from the patient perspective using focus groups. Arthritis Res Ther. 2006;8(4):R84.

ReferenceCitation: Daste C, Abdoul H, Foissac F, Papelard A, Alami S, Kwakkenbos L, Carrier ME, Lefèvre-Colau MM, Thombs BD, Poiraudeau S, Rannou F, Mouthon L, Nguyen C. Development of a new patient-reported outcome measure to assess activities and participation in people with systemic sclerosis: the Cochin 17-item Scleroderma Functional scale. Br J Dermatol. 2020 Oct;183(4):710-718. doi: 10.1111/bjd.18922. Epub 2020 Mar 18.

name: Université de Paris Faculté de Santé UFR Médecine de Paris Centre Sorbonne Paris Cité 75006 Paris France

name: AP‐HP Centre‐Université de Paris Service de Rééducation et de Réadaptation de l'Appareil Locomoteur et des Pathologies du Rachis Hôpital Cochin 75014 Paris France

name: Inserm UMR 1153 Centre de Recherche Épidémiologie et Statistique Sorbonne Paris Cité 75004 Paris France

family: Daste

full_name: C. Daste

given: C.

name: Unité de Recherche Clinique Centre d'Investigation Clinique Paris Descartes Necker/Cochin Hôpital Tarnier 75014 Paris France

family: Abdoul

full_name: H. Abdoul

given: H.

name: EA 7323, Évaluation des Thérapeutiques et Pharmacologie Périnatale et Pédiatrique 75014 Paris France

family: Foissac

full_name: F. Foissac

given: F.

family: Papelard

full_name: A. Papelard

given: A.

name: Cabinet d’Études Sociologiques Interlis 75006 Paris France

family: Alami

full_name: S. Alami

given: S.

name: Behavioural Science Institute Clinical Psychology, Radboud University Nijmegen the Netherlands

family: Kwakkenbos

full_name: L. Kwakkenbos

given: L.

name: Lady Davis Institute for Medical Research Jewish General Hospital Montreal QC Canada

family: Carrier

full_name: M.‐E. Carrier

name: Institut Fédératif de Recherche sur le Handicap 75013 Paris France

family: Lefèvre‐Colau

full_name: M.‐M. Lefèvre‐Colau

name: Departments of Psychiatry; Epidemiology, Biostatistics and Occupational Health; Medicine; Psychology; and Educational and Counselling Psychology; and the Biomedical Ethics Unit McGill University Montreal QC Canada

family: Thombs

full_name: B.D. Thombs

family: Poiraudeau

full_name: S. Poiraudeau

name: UMR‐S 1124, Toxicité Environnementale, Cibles Thérapeutiques Signalisation Cellulaire et Biomarqueurs (T3S) Centre Universitaire des Saints‐Pères 75006 Paris France

family: Rannou

full_name: F. Rannou

name: AP‐HP Centre‐Université de Paris, Service de Médecine Interne, Centre de Référence Maladies Systémiques Auto‐Immunes Rares d’Île‐de‐France, Hôpital Cochin 75014 Paris France

family: Mouthon

full_name: L. Mouthon

family: Nguyen

full_name: C. Nguyen

journal_name: British Journal of Dermatology

evidence: open (via free article)

publisher: Wiley

publisher_dissemination: Wiley

publisher_group: Wiley

publisher_normalized: Wiley

title: Development of a new patient‐reported outcome measure to assess activities and participation in people with systemic sclerosis: the Cochin 17‐item Scleroderma Functional scale

ReferenceCitation: Papelard A, Daste C, Alami S, Sanchez K, Roren A, Segretin F, Lefèvre-Colau MM, Rannou F, Mouthon L, Poiraudeau S, Nguyen C. Construction of an ICF core set and ICF-based questionnaire assessing activities and participation in patients with systemic sclerosis. Rheumatology (Oxford). 2019 Dec 1;58(12):2260-2272. doi: 10.1093/rheumatology/kez209.

name: AP-HP, Service de Rééducation et de Réadaptation de l’Appareil Locomoteur et des Pathologies du Rachis, Hôpitaux Universitaires Paris Centre-Groupe Hospitalier Cochin, France

full_name: Agathe Papelard

given: Agathe

name: INSERM UMR 1153, Centre de Recherche Épidémiologie et Statistique, Sorbonne Paris Cité, ECaMO Team, France

full_name: Camille Daste

given: Camille

full_name: Sophie Alami

given: Sophie

family: Sanchez

full_name: Katherine Sanchez

given: Katherine

name: Institut Fédératif de Recherche sur le Handicap, France

family: Roren

full_name: Alexandra Roren

given: Alexandra

family: Segretin

full_name: François Segretin

given: François

name: Université Paris Descartes, Faculté de Médecine, Sorbonne Paris Cité, France

name: INSERM UMR 1124, Laboratoire de Pharmacologie, Toxicologie et Signalisation Cellulaire, Faculté des Sciences Fondamentales et Biomédicales, Centre Universitaire des Saints-Pères, France

name: AP-HP, Service de Médecine Interne, Centre de Référence Maladies Systémiques Auto-Immunes Rares d’Île-de-France, Hôpitaux Universitaires Paris Centre-Groupe Hospitalier Cochin, Paris, France


title: Extra Pulmonary Determinants of Physical Activity in Adults With Cystic Fibrosis.

acronym: MUCO-DAP

summary:
Physical activity seems to be a prognostic factor for quality of life and survival in patients with cystic fibrosis (CF). Whereas their exercise capacity has been assessed through medical examination, their daily physical activity has been little studied. Activity monitors have measured physical activity only in a few studies which considered mainly respiratory status and more recently bone mineral density and body composition. Determinants of physical activity in patients with CF remain largely unknown.

The objective of this study is to measure daily physical activity with activity monitors in adult patients with CF and to investigate the determinants of physical activity, with a focus on extra-respiratory factors (nutritional status, diabetes, bone mineralization, anxiety and/or depression, cardiac impairment).

Seventy adult patients with CF, regularly cared at the Cochin adult CF centre, will be recruited in a stable period during their annual review. During this assessment, laboratory tests will be carried out (especially parameters for nutritional status), as well as measurement of body composition and bone mineral density, respiratory function tests and a 6 minute walk test, and echocardiography. Patients will wear for 7 consecutive days a multi-sensor armband SenseWear on the arm, to assess the intensity of physical activity in metabolic equivalents (METS) and steps per day. Finally, patients will complete three self-administered questionnaires: Quality of Life (CFQ14 +), hospital anxiety depression scale and physical activity.

After a descriptive analysis of the study cohort, we will study qualitative and quantitative criteria related to physical activity (assessed quantitatively by the number of steps/day or metabolic equivalents).

Linear regression models will then be developed to assess the independent factors associated with physical activity, adjusting for different variables of interest related to patients demographic, behavioral, clinical (respiratory and non-respiratory ) and biological parameters. Conversely, the "predictive" independent aspect of physical activity will be studied according to respiratory function, nutritional status and quality of life.

ReferenceCitation: Troosters T, Langer D, Vrijsen B, Segers J, Wouters K, Janssens W, Gosselink R, Decramer M, Dupont L. Skeletal muscle weakness, exercise tolerance and physical activity in adults with cystic fibrosis. Eur Respir J. 2009 Jan;33(1):99-106. doi: 10.1183/09031936.00091607. Epub 2008 Aug 20.

ReferenceCitation: Tejero García S, Giráldez Sánchez MA, Cejudo P, Quintana Gallego E, Dapena J, García Jiménez R, Cano Luis P, Gómez de Terreros I. Bone health, daily physical activity, and exercise tolerance in patients with cystic fibrosis. Chest. 2011 Aug;140(2):475-481. doi: 10.1378/chest.10-1508. Epub 2011 Feb 3.

ReferenceCitation: Watz H, Waschki B, Boehme C, Claussen M, Meyer T, Magnussen H. Extrapulmonary effects of chronic obstructive pulmonary disease on physical activity: a cross-sectional study. Am J Respir Crit Care Med. 2008 Apr 1;177(7):743-51. Epub 2007 Nov 29.

ipd_sharing: No


title: Randomized, Placebo-controlled Double-blind Study to Evaluate the Effects of Fructo-oligosachharides on Increase of Stool Frequency in Constipated People

summary: The study aims to evaluate the effects of short-chain fructo-oligosaccharides on the frequency and constistency of stools in subjects with functional constipation

lead_sponsor: Syral

intervention_type: Dietary Supplement


ReferenceCitation: Nguyen-Khac E, Lobry C, Chatelain D, Fuks D, Joly JP, Brevet M, Tramier B, Mouly C, Hautefeuille V, Chauffert B, Regimbeau JM. A Reappraisal of Chemotherapy-Induced Liver Injury in Colorectal Liver Metastases before the Era of Antiangiogenics. Int J Hepatol. 2013;2013:314868. doi: 10.1155/2013/314868. Epub 2013 Mar 7.

lead_sponsor: Centre Hospitalier Universitaire, Amiens

acronym: CAMFIB

source: euctr

title: Evaluation of Indocyanine Green Fluorescent Cholangiography Versus Methylene Blue to Detect Postoperative Biliary Fistula After Hepatectomy: Randomized Controlled Study

summary: The aim of the present study is to evaluate whether the use of indocyanine green fluorescent cholangiography is responsible in a decrease of biliary fistula's rate in patients with liver diseases requiring liver resection.


title: Implementation of a Therapeutic Educational Program Applicated to Adherence of Patients Treated by Capecitabine Alone or in Combination With Lapatinib

acronym: ProMETheX

summary: The purpose of this study is to evaluate the efficacy of the implementation of an educational program on adherence to capecitabine alone or in combination to lapatinib.


title: Evaluation of Immune Response Against Human Papillomavirus (HPV)in Patients With Metastatic Cancer of the Anal Canal

summary:
Complete response is a rare event in metastatic anal cancer in the case of unresectable recurrence after radiochemotherapy.

In the University Hospital Center of Besançon, 8 patients with metastatic anal cancer were treated between 2005 and 2008 by 6 cycles of chemotherapy including taxane: DCF (Docetaxel, Cisplatin and 5-Fluorouracil.

In more than 90% of cases, anal cancers are related to Human Papilloma Virus (HPV) infection, that is the case of this patients for which HPV16 (human papillomavirus type 16) genotype was identified within the tumor samples.

The hypothesis is that an anti-HPV response immune could be generated by chemotherapy with DCF and contributed to the elimination of the tumour cells and to the increase of complete responses. The aim to this study is to analyze immune response against HPV in this patients in complete response.

location_facility: Medical Oncology - University Hospital of Besançon


title: The Prevalence of Chronic Kidney Disease at Adolescence in Patients With Congenital Cardiac Disease, Having Undergone Corrective Surgery During Childhood

acronym: PRECARDIO

summary: The prevalence of chronic kidney injury (CKD) following cardiac surgery during childhood is not known, but there is evidence of CKD in young adults. In the present study assumption is made that CKD can already by diagnosed in patients at or just before adolescence, and the aim is calculate its prevalence according to the KDIGO criteria by a cross-sectional study, which will enroll patients aged 10 to 15 years. The second hypothesis is that events occurring peri-operatively during initial surgery or during follow-up could by chart review and regression analysis.

ReferenceCitation: Dimopoulos K, Diller GP, Koltsida E, Pijuan-Domenech A, Papadopoulou SA, Babu-Narayan SV, Salukhe TV, Piepoli MF, Poole-Wilson PA, Best N, Francis DP, Gatzoulis MA. Prevalence, predictors, and prognostic value of renal dysfunction in adults with congenital heart disease. Circulation. 2008 May 6;117(18):2320-8. doi: 10.1161/CIRCULATIONAHA.107.734921. Epub 2008 Apr 28.

ReferenceCitation: Hogg RJ, Furth S, Lemley KV, Portman R, Schwartz GJ, Coresh J, Balk E, Lau J, Levin A, Kausz AT, Eknoyan G, Levey AS; National Kidney Foundation's Kidney Disease Outcomes Quality Initiative. National Kidney Foundation's Kidney Disease Outcomes Quality Initiative clinical practice guidelines for chronic kidney disease in children and adolescents: evaluation, classification, and stratification. Pediatrics. 2003 Jun;111(6 Pt 1):1416-21.

ReferenceCitation: Levey AS, Eckardt KU, Tsukamoto Y, Levin A, Coresh J, Rossert J, De Zeeuw D, Hostetter TH, Lameire N, Eknoyan G. Definition and classification of chronic kidney disease: a position statement from Kidney Disease: Improving Global Outcomes (KDIGO). Kidney Int. 2005 Jun;67(6):2089-100.

ReferenceCitation: Pedersen KR, Hjortdal VE, Christensen S, Pedersen J, Hjortholm K, Larsen SH, Povlsen JV. Clinical outcome in children with acute renal failure treated with peritoneal dialysis after surgery for congenital heart disease. Kidney Int Suppl. 2008 Apr;(108):S81-6. doi: 10.1038/sj.ki.5002607.

ReferenceCitation: Askenazi DJ, Feig DI, Graham NM, Hui-Stickle S, Goldstein SL. 3-5 year longitudinal follow-up of pediatric patients after acute renal failure. Kidney Int. 2006 Jan;69(1):184-9.


title: Study of Eating in the Absence of Hunger and of Caloric Compensation in French Children, and of Their Relationships With Parental Feeding Practices

summary:
Objectives: The aims were to measure caloric compensation (CC) and eating in the absence of hunger (EAH) in 2 to 7 year-old French children in their regular eating context and to link these measurements with individual characteristics (adiposity, age, gender) and parental feeding practices.

Design: Three consecutive weeks an identical lunch was served in four preschool canteens reaching 236 children. The first lunch was a control session. For the CC situation (week 2), thirty minutes before the lunch children were offered a preload (137 kcal). For the EAH situation (week 3), ten minutes after lunch children were exposed to palatable foods (430 kcal). Food intake was measured at the individual level. Parental eating behaviour and feeding practices were measured by questionnaires. Child's height and weight were measured by a medical doctor.

time_perspective: Cross-Sectional

ReferenceCitation: Remy E, Issanchou S, Chabanet C, Boggio V, Nicklaus S. Impact of adiposity, age, sex and maternal feeding practices on eating in the absence of hunger and caloric compensation in preschool children. Int J Obes (Lond). 2015 Jun;39(6):925-30. doi: 10.1038/ijo.2015.30. Epub 2015 Mar 17.

family: Remy

full_name: E Remy

given: E

family: Issanchou

full_name: S Issanchou

given: S

family: Chabanet

full_name: C Chabanet

given: C

family: Boggio

full_name: V Boggio

given: V

family: Nicklaus

full_name: S Nicklaus

journal_name: International Journal of Obesity

location_facility: Centre des sciences du goût et de l'alimentation


title: Improving the Assessment of Pulmonary Vein Disconnection With the Achieve Catheter During Atrial Fibrillation Cryoablation

summary: According to data from high volume Centres, documentation of entry block with the Achieve catheter may be possible in only about to 50% of pulmonary veins. The investigators aim to assess strategies using the Achieve catheter that can improve this performance.

ReferenceCitation: Boveda S, Providência R, Albenque JP, Combes N, Combes S, Hireche H, Casteigt B, Bouzeman A, Jourda F, Narayanan K, Marijon E. Real-time assessment of pulmonary vein disconnection during cryoablation of atrial fibrillation: can it be 'achieved' in almost all cases? Europace. 2014 Jun;16(6):826-33. doi: 10.1093/europace/eut366. Epub 2013 Dec 18.

family: Boveda

full_name: S. Boveda

family: Providencia

full_name: R. Providencia

given: R.

family: Albenque

full_name: J.-P. Albenque

family: Combes

full_name: N. Combes

given: N.

full_name: S. Combes

family: Hireche

full_name: H. Hireche

family: Casteigt

full_name: B. Casteigt

given: B.

family: Bouzeman

full_name: A. Bouzeman

family: Jourda

full_name: F. Jourda

family: Narayanan

full_name: K. Narayanan

given: K.

family: Marijon

full_name: E. Marijon

given: E.

journal_name: Europace

publisher: Oxford University Press (OUP)

publisher_dissemination: Oxford University Press

publisher_group: Oxford University Press

publisher_normalized: Oxford University Press

lead_sponsor: Clinique Pasteur


title: Erectile Rating During the Treatment of Rectal Cancers Localized. Exploratory Study

acronym: METEORR

summary: Erectile dysfunction will be explored by recording R / P and self-administered questionnaire IIEF-5.

lead_sponsor: Institut Bergonié


title: Associating Liver Partition and Portal Vein Ligation (ALPPS) for Potentially Resectable Liver Metastasis From Colorectal Cancer: Prospective Evaluation of the Early Two-stage Hepatectomy by the Simon's Methods

summary: The aim of this study is evaluate the feasibility of early two-stage hepatectomy in patients with liver metastasis from colorectal cancer.


title: Feasibility of the Use of Ultrasound-guided Paravertebral Catheterisation for the Analgesic Management of Thoracotomy

acronym: BPV échoguidé

summary:
Thoracotomy, is a surgical procedure performed routinely in connection with pulmonary surgery. Pain induced by thoracotomy is considered as the most severe post-operative pain. Control of the pain is essential in the perioperative management.

Nowadays, there are several strategies to support this pain, including regional anesthesia techniques in the context of multimodal analgesia. Epidural analgesia reduces pain scores and respiratory complications significantly. ParaVertebral Block (PVB) is a technique as effective as epidural analgesia in the treatment of pain after thoracotomy and could present a more limited number of complications. However, there is no consensus on the best technique for realisation of PVB.

Para-vertebral catheterisation can be performed by posterior approach in seeking a strength loss after bone contact of transverse vertebral process using the technique of Eason and Wyatt, but it is a blind technique. The ultrasonographic control, developed in the context of all puncture invasive actions, is an effective contribution to the realisation of a BPV, but still insufficiently validated. First used to measure the distance skin - posterior costo-transverse ligament and skin - parietal pleura before procedure, the ultrasonography has recently led to the publication of echo-guided techniques combining recognition of structures defining the space para- vertebral, viewing the progression of the needle and the spread of the local anesthetic. The handling of the ultrasonographic probe associated with the puncture requires additional learning.

The objective of this project is to study the feasibility of para-vertebral catheter insertion under ultrasonographic control. The appearance like "pigtail" of the catheter, the most recently proposed, seems the more attractive in terms of safety. The aim of this pilot prospective study is accurately quantify all qualitative parameters related to the technique in order to achieve a future validation with a medico-economic component.

Ultrasound-guided technique will correspond to a technique with a puncture of the lateral to medial space described by Shibata, after spotting of the first rib proposed by Bouzinac.

This study will be proposed to patients undergoing thoracotomy for total or partial pulmonary resection in Thoracic Surgery service of Centre Jean Perrin, the number of patients required is 60 patients over a period of inclusion of 12 months.

location_facility: Centre de lautte contre le cancer - Centre Jean Perrin


title: Prenatal Screening for Imprinting Anomalies Implicated in Beckwith Wiedemann and Silver Russell Syndromes

acronym: DASIRUWIBE

summary:
Losses of imprinting are involved in various syndromes. Those occurring in the 11p15 region lead to Beckwith-Wiedemann and Silver-Russell Syndromes. These losses of imprinting follow a mosaic pattern, rendering their detection difficult, especially given the scarcity of available DNA in amniotic fluid. Thus, in spite of growing demand, prenatal diagnosis (PND) for imprinting abnormalities of the 11p15 region is not available.

The recent development of a quantitative PCR method that permits the methylation index (MI) of imprinted regions to be calculated renders PND technically possible. Nevertheless, because of the mosaic nature of these anomalies, it is essential to verify that the methylation pattern of the 11p15 region obtained from the amniotic fluid matches that obtained from the blood.

intervention_type: Genetic


title: Bariatric Surgery, Nutrition, and Sperm Quality of Adult Obese Men on Childbearing Age : A Multicentric Cohort Study

acronym: BARIASPERM

summary: The purpose of this study is to evaluate the impact of a bariatric surgery (gastric banding, bypass, sleeve gastrectomy) on several parameters (quality of sperm and others biological parameters, lifestyle, quality of life) involved in fertility of obese adult men.

primary_purpose: Screening

ReferenceCitation: di Frega AS, Dale B, Di Matteo L, Wilding M. Secondary male factor infertility after Roux-en-Y gastric bypass for morbid obesity: case report. Hum Reprod. 2005 Apr;20(4):997-8. Epub 2004 Dec 23.

ReferenceCitation: MacDonald AA, Herbison GP, Showell M, Farquhar CM. The impact of body mass index on semen parameters and reproductive hormones in human males: a systematic review with meta-analysis. Hum Reprod Update. 2010 May-Jun;16(3):293-311. doi: 10.1093/humupd/dmp047. Epub 2009 Nov 4. Review.

ReferenceCitation: Sermondade N, Massin N, Boitrelle F, Pfeffer J, Eustache F, Sifer C, Czernichow S, Lévy R. Sperm parameters and male fertility after bariatric surgery: three case series. Reprod Biomed Online. 2012 Feb;24(2):206-10. doi: 10.1016/j.rbmo.2011.10.014. Epub 2011 Nov 3.


title: Management of Ductal Carcinoma in Situ (DCIS) or Pure Micro-invasive (DCIS-MI) Extended Breast, Axillary Node Sentinel Site (GAS) When the Diagnosis is Made by Biopsy and Treatment by Mastectomy Immediately. Descriptive Study

acronym: CINNAMOME

summary: The rate of axillary dissection avoided in patients with Ductal Carcinoma in Situ (DCIS) and a mastectomy indication will be obtained by calculating the proportion of women with GAS in-patient population that will prove to be DCIS or DCIS-MI + CCI. A confidence interval of 95% will be deferred.

ReferenceCitation: Tunon-de-Lara C, Chauvet MP, Baranzelli MC, Baron M, Piquenot J, Le-Bouédec G, Penault-Llorca F, Garbay JR, Blanchot J, Mollard J, Maisongrosse V, Mathoulin-Pélissier S, MacGrogan G. The Role of Sentinel Lymph Node Biopsy and Factors Associated with Invasion in Extensive DCIS of the Breast Treated by Mastectomy: The Cinnamome Prospective Multicenter Study. Ann Surg Oncol. 2015 Nov;22(12):3853-60. doi: 10.1245/s10434-015-4476-5. Epub 2015 Mar 17.

family: Tunon-de-Lara

full_name: Christine Tunon-de-Lara

given: Christine

family: Chauvet

full_name: Marie Pierre Chauvet

given: Marie Pierre

family: Baranzelli

full_name: Marie Christine Baranzelli

given: Marie Christine

family: Baron

full_name: Marc Baron

given: Marc

family: Piquenot

full_name: Jean Piquenot

given: Jean

family: Le-Bouédec

full_name: Guillaume Le-Bouédec

given: Guillaume

family: Penault-Llorca

full_name: Fréderique Penault-Llorca

given: Fréderique

family: Garbay

full_name: Jean-Rémi Garbay

given: Jean-Rémi

family: Blanchot

full_name: Jérôme Blanchot

given: Jérôme

family: Mollard

full_name: Joëlle Mollard

given: Joëlle

family: Maisongrosse

full_name: Véronique Maisongrosse

given: Véronique

family: Mathoulin-Pélissier

full_name: Simone Mathoulin-Pélissier

given: Simone

family: MacGrogan

full_name: Gaëtan MacGrogan

given: Gaëtan

journal_name: Annals of Surgical Oncology

license: implied-oa

license_normalized: implied-oa


title: Evaluation of a 6 Months Treatment of Conceptio (EA) on Sperm Data in Infertile Men With Oligoasthenozoospermia

summary: Male infertility is a multifactorial disease process with a number of potential contributive causes. Considering the majority of male infertility cases are due to deficient sperm production of unknown origin, environmental and nutritional factors must be evaluated. The purpose of this study is to evaluate the effects of 6 months antioxidant dietary complement (Conceptio) on sperm parameters (sperm count, motility and DNA fragmentation) in infertile men with oligoasthenozoospermia.


title: Longitudinal Study of a Children Population With Bilateral Severe Cerebral Palsy: Incidence and Evolution of Orthopaedic Complications and Pain Related With These Complications.

acronym: CPCohort

summary:
" Cohort CP " is a multicentre cohort study, initiated by the Hospices Civils de Lyon in September 2009. Population targeted are children with bilateral cerebral palsy, level GMFCS IV or V, aged from 2 to 10 years at inclusion. They are followed-up during 10 years, at the rhythm of 1 visit per year. At each visit are collected clinical, orthopaedic, radiological and environmental data.

The primary objective is to establish the incidence of orthopaedic complications (scoliosis and hip joint) depending on patients' age.

Secondary objectives are to describe the sequences over time of these complications and the related pain, to explore the impact of nutrition, surgery, asymmetric postures and environmental factors, and to describe the medical and rehabilitative follow-up of these patients.

385 patients are expected by the end of 2020. We expect of this long-term follow-up to gain tools that permit to improve patient's care and patient's quality of life, by putting in place preventing actions and adapted treatments related to their own pathologies.

location_facility: Hospices Civils de Lyon - Hôpital Femme Mère Enfant


title: Evaluation of the Efficacy and Tolerability of Treatment With Interleukin-2 in Severe Alopecia Areata Resistant to Conventional Systemic Treatment

summary: Alopecia areata is an autoimmune disease associated with infiltration of cluster of differentiation 4(CD4 +) and cluster of differentiation 8 (CD8) + cells around the hair follicles. One of the therapeutic approaches of inflammatory diseases such as alopecia areata is the induction of tolerance. This tolerance induction can be obtained by stimulating regulatory T cells (Treg). The low-dose interleukin-2 plays a central role in the development, expansion, regulation and survival of regulatory T cells CD4 + cluster of differentiation 25 (CD25) + forkhead box protein 3 (FoxP3). Recently, recombinant interleukin 2 (IL2-R) with low dose showed very promising results in two inflammatory disease (GVHD vasculitis and cryoglobulinemia secondary to hepatitis C): clinical efficacy, increased population Treg in the blood and an excellent safety profile. We hypothesized that administration of IL2-R in patients with severe alopecia areata might allow regrowth via activation of Treg and thus induce regrowth of the air.

ReferenceCitation: Castela E, Le Duff F, Butori C, Ticchioni M, Hofman P, Bahadoran P, Lacour JP, Passeron T. Effects of low-dose recombinant interleukin 2 to promote T-regulatory cells in alopecia areata. JAMA Dermatol. 2014 Jul;150(7):748-51. doi: 10.1001/jamadermatol.2014.504.

family: Castela

full_name: Emeline Castela

given: Emeline

name: Department of Dermatology, University Hospital of Nice, Nice, France2Centre de Recherche Clinique (CRC), University Hospital of Nice, Nice, France

family: Le Duff

full_name: Florence Le Duff

given: Florence

name: Laboratory of Clinical and Experimental Pathology, University Hospital of Nice, Nice, France

family: Butori

full_name: Catherine Butori

given: Catherine

name: Laboratory of Immunology, University Hospital of Nice, Nice, France

family: Ticchioni

full_name: Michel Ticchioni

given: Michel

family: Hofman

full_name: Paul Hofman

given: Paul

family: Bahadoran

full_name: Philippe Bahadoran

given: Philippe

family: Lacour

full_name: Jean-Philippe Lacour

given: Jean-Philippe

name: Department of Dermatology, University Hospital of Nice, Nice, France5Institut National de la Santé et de la Récherche Médicale (INSERM) U1065, Team 12, Mediterranean Centre of Molecular Medicine, Nice, France

family: Passeron

full_name: Thierry Passeron

given: Thierry

title: Effects of Low-Dose Recombinant Interleukin 2 to Promote T-Regulatory Cells in Alopecia Areata


title: A Monocenter Prospective Study to Evaluate the Efficacy of Peripherally Inserted Central Catheter to Tunnelled Central Catheter With Cuff in Home Parenteral Nutrition for Long-term Used: the PICCnut Study.

acronym: PICCNUT

summary:
Home parenteral nutrition (HPN) is the reference treatment for anatomic or fonctionnal chronic intestinal failure. Nutritionnal catheter must follow two rules: low infection rate and be able to preserve the permeability of the central vein. Today, in europeen guidelines, two types of central devices are recommended: tunnelled central catheter with cuff and implanted ports. However, their insertion is not without risk. Since many years, we have seen a new generation of catheter - peripherally inserted central catheter (PICC line)- which have many advantage over other central catheter. ESPEN guidelines accept the use of PICC line in short and moderate-term for HPN, but no prospective study have look for long-term used in HPN.

The objective of our study is to evaluate in a prospective randomised monocenter study the no-inferiority of PICC line to tunnelled central catheter with cuff for serious catheter related-complications such as infection and thrombophlebitis for patient on HPN over 1 month of duration. The secondary objectives are to: evaluate the number of patients with at least one serious complications related in 1000 days of used, the rate of minors and majors complications, number of catheter inserted, the satisfaction of patients and doctors.

The study is held in CHU Nice and will be proposed to hospitalized patients who will need HPN. After consent, patients will be randomized to receive PICC Line (group A) of nutritional central catheter with cuff (group B). Echography of vessels will be held at the beginning, 3 months and 12 months. Follow-up will be conduct at regular interval (month 0-1-3-6-9-12). The duration of follow-up will be of 12 months and the global duration of the study will be 36 months. One major complication will conduct to withdrawal of the study. There will be 55 patients in each group.

primary_purpose: Prevention


title: Regional Citrate Versus Systemic Heparin Anticoagulation for Super High-flux Continuous Hemodialysis in Septic Shock: Effect on Middle Molecular Weight Molecules Clearances

acronym: RCA-SHA

summary:
Sepsis is responsible for 50% of all acute kidney injury (AKI) in intensive care units (ICUs), contributing greatly to multiple organ dysfunction syndrome (MODS). Special types of continuous renal replacement therapies (CRRT) have been proposed as adjuvant therapies for septic shock due to their ability to remove middle molecular weight molecules such as inflammatory mediators involved in MODS pathophysiology. These therapies are called extracorporeal " blood purification " therapies.

When CRRT is used, an anticoagulation is required to prevent clotting of the extracorporeal circuit, possibly causing bleeding in selected patients. Many anticoagulation strategies have been proposed and the most commonly used in 2013 is still unfractionated heparin. Regional citrate anticoagulation (RCA) is an interesting alternative as it dramatically decreases the bleeding risk.

The investigators hypothesize that the use of citrate with Super High Flux Continuous Veno-Venus Hemodialysis (SHF-CVVHD) would be highly beneficial over time by preserving the filter effectiveness via limiting protein adhesion (which subsequently reduces filter pore sizes (protein cake)), as compared to heparin. Consequently, higher clearances of the inflammatory mediators could be maintained over time with citrate as compared to heparin anticoagulation. In other words, for the same duration of filter use, middle molecular weight molecules and cytokines clearances would be greater with citrate as compared to heparin. To test this hypothesis, the investigators will perform a clinical randomized controlled trial which aim would be to compare middle molecular weight molecules and cytokines clearances in SHF-CVVHD using RCA versus systemic heparin anticoagulation in septic patients with AKI.

ReferenceCitation: Tsujimoto H, Tsujimoto Y, Nakata Y, Fujii T, Takahashi S, Akazawa M, Kataoka Y. Pharmacological interventions for preventing clotting of extracorporeal circuits during continuous renal replacement therapy. Cochrane Database Syst Rev. 2020 Dec 14;12:CD012467. doi: 10.1002/14651858.CD012467.pub3.

name: Hospital Care Research Unit; Hyogo Prefectural Amagasaki General Medical Center; Hyogo Japan

family: Tsujimoto

full_name: Hiraku Tsujimoto

given: Hiraku

name: Department of Healthcare Epidemiology; School of Public Health in the Graduate School of Medicine, Kyoto University; Kyoto Japan

full_name: Yasushi Tsujimoto

given: Yasushi

name: Department of Mathematics; Shimane University; Matsue Japan

family: Nakata

full_name: Yukihiko Nakata

given: Yukihiko

name: Australian and New Zealand Intensive Care Research Centre, Department of Epidemiology and Preventive Medicine; Monash University; Melbourne Australia

family: Fujii

full_name: Tomoko Fujii

given: Tomoko

name: Center for Innovative Research for Communities and Clinical Excellence (CiRC2LE); Fukushima Medical University; Fukushima Japan

family: Takahashi

full_name: Sei Takahashi

given: Sei

name: Department of Anesthesia; Shiga University of Medical Science Hospital; Otsu Japan

family: Akazawa

full_name: Mai Akazawa

given: Mai

name: Department of Respiratory Medicine; Hyogo Prefectural Amagasaki General Medical Center; Hyogo Japan

family: Kataoka

full_name: Yuki Kataoka

given: Yuki

journal_name: Cochrane Database of Systematic Reviews

location_facility: Service de Réanimation - Pavillon P, Hôpital Edouard Herriot


title: Prediction of Hemodynamic Reactivity During Desflurane/Remifentanil General Anesthesia Using Analgesia/Nociception Index (ANI)

summary: The aim of this study is to evaluate the performance of Analgesia/Nociception Index for the prediction of hemodynamic reactivity in adult patients undergoing ear-nose-throat or lower limb orthopedic surgery on desflurane/remifentanil general anesthesia.

ReferenceCitation: Boselli E, Daniela-Ionescu M, Bégou G, Bouvet L, Dabouz R, Magnin C, Allaouchiche B. Prospective observational study of the non-invasive assessment of immediate postoperative pain using the analgesia/nociception index (ANI). Br J Anaesth. 2013 Sep;111(3):453-9. doi: 10.1093/bja/aet110. Epub 2013 Apr 16.


title: PROSPECTIVE EVALUATION OF OUTPATIENT APPENDECTOMY FOR NON COMPLICATED ACUTE APPENDICITIS: Intention-to-treat Study

acronym: APPENDAMBU

summary: The aim of our monocentric prospective in intention-to-treat study is to evaluate the feasibility of outpatient appendectomy for non complicated acute appendicitis.

ReferenceCitation: Sabbagh C, Brehant O, Dupont H, Browet F, Pequignot A, Regimbeau JM. The feasibility of short-stay laparoscopic appendectomy for acute appendicitis: a prospective cohort study. Surg Endosc. 2012 Sep;26(9):2630-8. doi: 10.1007/s00464-012-2244-1. Epub 2012 Mar 23.

ReferenceCitation: Sabbagh C, Masseline L, Grelpois G, Ntouba A, Dembinski J, Regimbeau JM. Management of Uncomplicated Acute Appendicitis as Day Case Surgery: Can Outcomes of a Prospective Study Be Reproduced in Real Life? J Am Coll Surg. 2019 Sep;229(3):277-285. doi: 10.1016/j.jamcollsurg.2019.04.031. Epub 2019 May 13.

family: Sabbagh

full_name: Charles Sabbagh

given: Charles

family: Masseline

full_name: Loréna Masseline

given: Loréna

family: Grelpois

full_name: Gérard Grelpois

given: Gérard

family: Ntouba

full_name: Alexandre Ntouba

given: Alexandre

family: Dembinski

full_name: Jeanne Dembinski

given: Jeanne

family: Regimbeau

full_name: Jean-Marc Regimbeau

given: Jean-Marc

journal_name: Journal of the American College of Surgeons

publisher: Elsevier BV

publisher_dissemination: Elsevier

publisher_group: Elsevier

publisher_normalized: Elsevier


title: Biological Rhythms and Vestibular System

summary: The purpose of this study is to study the relationship between the vestibular system and chronobiology

primary_purpose: Basic Science

lead_sponsor: University Hospital, Caen


title: Neuropsychological Impact of Hospitalization on Intubated, Ventilated and Sedated ICU Patients

acronym: NeuroPsy Réa

summary:
This is a prospective, single-center, pilot, cohort study. The first phase of this study is observational and the usual care of patients is maintained during the ICU stay, except for an interview with a psychologist preceding patient discharge. A phone interview at 2 months and a visit with a psychologist at four months after ICU discharge are specific to the study.

The main objective of this study is to make a first estimate of the percentage of patients (CI = +- 10%) with cognitive impairment at four months after ICU discharge. The presence / absence of cognitive impairment will be determined by the D2 test.

lead_sponsor: Centre Hospitalier Universitaire de Nīmes

location_facility: CHU de Nîmes - Hôpital Universitaire Carémeau


title: Differentiated Thyroid Cancer: is There a Need for Radioiodine Ablation in Low Risk Patients?

summary:
Open-label randomized phase III trial, using a non-inferiority comparison design. After randomization,patients will receive either post-operative radioiodine ablation with an activity of 1.1 GBq (30 mCi) after stimulation by rhTSH, and then be followed-up (ablation group) or be followed-up (without postoperative radioiodine ablation) (follow-up group).

The objective is to assess the non-inferiority of the proportion of patients without tumor-related event evaluated at three years after randomisation in the absence of radioiodine ablation (follow-up group) compared to the ablation group, in patients with low-risk differentiated thyroid cancer treated with total thyroidectomy with or without lymph node dissection (pT1am N0 or Nx, pT1b N0 or Nx)

status: Active, not recruiting

lead_sponsor: Gustave Roussy, Cancer Campus, Grand Paris


title: Effectiveness of Relational Touch in the Management of Chronic Pain in Institutionalized Elderly

acronym: EFFITOUREL

summary: The aim is to investigate the feasibility and efficacy of a relational touch / relational intervention on persistent pain in a long term geriatric hospital care ward population. The main issue is the pain reduction. The hypothesis is that this type of intervention is very useful on pain reduction in old people even with physical or mental disability.

location_facility: Hopital René Muret - Head of department Long Term hospital ward


title: Evaluation of the Bone Mineralization by Quantitative Computed Tomodensitometry in Patients With Cystic Fibrosis : Validation Study

acronym: TOMODENS

summary: The purpose of this study is to conduct a comparative study for the study of bone mineralization evaluated with Quantitative computed tomodensitometry (QCT) compared to the reference technique, Dual-emission X-ray absorptiometry (DXA).

lead_sponsor: Hôpital Necker-Enfants Malades


title: Individual Versus Grouped Debriefing Approaches in Anaesthesia Crisis Simulation-Based Training. What Impact On The Technical Score ?

acronym: DEBRIEF-SIM

summary:
Simulation-based training is essential in learning or maintaining skills in high risk industry such as aviation and railway and in the medical field like anaesthesia. Debriefing following simulation is fundamental in order to reduce the emotional impact of the session and to asses the technical and non-technical skills (behavior). Even if the ideal debriefing method is still to be found, individual debriefing is considered as the gold standard but time consuming. The DEBRIEF-SIM study is a prospective, single blinded, multicentric and randomized study that will compare the individual (defined by learning couple resident and nurse) approach to a grouped (several couples) debriefing. The primary end point is to define the noninferiority of this approach compared to the individual one on the educational impact.

The learners will be debriefed according to their randomization after the first session, but will all undergo individual debriefing following the second session.

lead_sponsor: Centre Hospitalier Universitaire de Besancon

location_facility: Faculté de Franche-Comte des études de medecine et pharmaceutiques


title: Identification of Early Markers of Response and Resistance to Trastuzumab in Patients With Localized Human Epidermal Growth Factor Receptor-2(HER-2)-Positive Breast Cancer Candidates for Breast Conserving Surgery

acronym: HERBIN

summary: The study is a single arm prospective study, aiming at identifying biomarkers of early response to trastuzumab. It is a prognostic factor study recruiting all consecutive cases of HER-2 positive breast cancer eligible for a pre-operative treatment by trastuzumab, followed by breast conserving surgery. The investigators will study the association between the value of biomarkers measured at diagnosis and the Response Evaluation Criteria in Solid Tumors response (partial and complete response) using a logistic regression (main analysis).


title: Consultation at 8 Days to Reduce Hospitalisations in Heart Failure Patient.

acronym: CHIC

summary: Evaluate the benefit of systematic appointment with a cardiologist a week after hospitalisation for acute heart failure. Randomised, endpoint: number of day alive out of hospital during 6 months

primary_purpose: Supportive Care

ipd_sharing: Undecided

lead_sponsor: Assistance Publique - Hôpitaux de Paris


title: Physical and Psychological Evaluation of Patients Reaching End Stage Renal Disease : Effects on the Choice of Renal Replacement Therapy

summary: Highlighting the relationship between psychological and physical profiles and patient's preference to better understand the patient's treatment preference and improve the information provided.


title: Subgenual Cingulate Stimulation in Resistant Depression

summary:
Despite the availability of several treatments, a number of patients with major depression are refractory to therapeutical approaches and therefore suffer from chronic handicap. For these severe patients, neurosurgical therapies can be envisaged. They aim at interrupting bundles that link the orbitofrontal cortex with striatum and can therefore benefit for the patients.

This study intends to repeat Dr. Lozano's study, published in 2005 in the journal Neuron. In this study, they performed a preliminary evaluation of chronic deep brain stimulation (DBS) of the subgenual cingulate region (Brodmann area 25) to treat refractory depression as an alternative to subcaudate tractotomy. This last technique was employed in Grenoble in the 60s with satisfying results before neurosurgery for psychiatric disorders was abandoned. Since 1992, psychosurgical therapies that respect ethical recommendations have regained interest to treat highly impaired patients. Before the investigators can propose deep brain stimulation of subgenual cingulate brain region as a new therapeutic approach for the investigators patients in Grenoble, the investigators decided to reproduce their clinical evaluation on a group of 6 patients, repeating their methodology faithfully. Therefore nothing was changed to the model used by Drs. Lozano and Mayberg and the investigators took advantage of the investigators own expertise regarding deep brain stimulation and subcaudate tractotomy.

Protocol is strictly identical to the one of Mayberg and Lozano in order to confirm their preliminary results. Cartography of physiological consequences of this procedure will be assessed by measuring cerebral blood flow by PET scan (positron emission tomography). Patients will be monitored and thoroughly assessed during including psychiatric, neurological, neurosurgical, neuropsychological and PET scan exams to measure treatment efficacy and potential adverse reactions. Patients will be followed for two more years to assess medium-term complications. This study will be a first step toward further research including potentially a multicentric clinical trial.


title: Preliminary Study Leading to Prevention of Pressure Ulcers by the Use of an On-board Device : Ergonomic Assessment of Wheelchair-seat Pressures in Spinal Cord Injured (SCI) Patients

acronym: PRESDIE

summary: Analysis of stored seat-pressures in SCI patients during a 4-week use of an on-board device. During this period, patients write in an agenda noteworthy events that could occur while they're using their wheelchair. A control is done every week and the device can be changed until it is returned at the end of the study period.

lead_sponsor: Nantes University Hospital


title: Hodgkin's Lymphoma: Prognostic Value of the Kinetic of Decrease of 5 Cytokines Concentration During Treatment

acronym: CYTOKINES-LH

summary:
More than 90% of patients with Hodgkin lymphoma (HL) can recover thanks to conventional polychemotherapy regimens - ABVD or BEACOPP - with or without radiotherapy. Nevertheless, some patients relapse and others are resistant to any treatment. These patients represent 2-5% of stage I / II and 5-10% of disseminated stages. The usual prognostic index based on clinical and biological data (supradiaphragmatic HL: EORTC and advanced HL International Prognostic Score) cannot always detect patients at risk.

New prognostic factors are required to screen out these high risk patients. Among available biological factors, we will retain the cytokines secreted by tumor cells and cells from the environment.

Indeed, the prognostic value of plasma cytokines levels and their soluble receptors has recently been described by at least two teams. Olivier CASASNOVAS set up a prognostic index based on quantities of IL-1 RA, IL-6, sCD30 and TNFR1 at diagnosis,and the V. Diehl team published the prognostic value of the decrease of TARC (CC Thymus and Activation-related chemokine).

In daily practice, the early assessment of response by PET CT-scan is now an undeniable prognostic factor. Early identification of no-response or relapse is, in fact, based on clinical and imaging (PET-CT scan).

We propose to evaluate the decrease of cytokines concentration with a prognostic value (TARC, IL-6, IL1-RA, sCD30, TNFR1) as markers of response during treatment and during early follow-up. The dosage of these cytokines will be paired with radiological assessments.

A correlation between the decrease of cytokines plasma levels overtime and event-free survival will be searched afterwards.

lead_sponsor: Centre Henri Becquerel


title: Efficiency and Tolerance of a Small-peptide Enteral Feeding Formula Compared to a Whole-protein Formula in the Critically Ill Patient : a Prospective Randomized Trial

summary:
An early and efficient enteral nutritional support could improve the clinical outcomes of brain injured critically ill patients. Gastrointestinal feeding intolerance defined as an increased gastric residual volume frequently occurs in these patients.

Previous experimental studies have suggested that a small-peptide enteral feeding formula could promote the gastric emptying compared to a whole-protein formula. An improved gastrointestinal tolerance of enteral nutrition should allow a rapid increase in the daily caloric intake and enhance nutritional support of brain injured critically ill patients.

location_facility: Surgical Critical Care Unit, CHRU Jean Minjoz


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

acronym: FacialReinn

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

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

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

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

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

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

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

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

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


title: Infertility and Endometriosis : a Prospective Cohort Study

acronym: EndoFertil

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

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

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

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

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

lead_sponsor: University Hospital, Montpellier


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

acronym: NeoNIRS

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


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

acronym: ECHORACHIS

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

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

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

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

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

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

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

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


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

acronym: VARIETE

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

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

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

name: 1Université Paris-Saclay, Inserm, Physiologie et Physiopathologie Endocriniennes, Assistance Publique-Hôpitaux de Paris, Hôpital de Bicêtre, Service d’Endocrinologie et des Maladies de la Reproduction, Centre de Référence des Maladies Rares de l’Hypophyse, Le Kremlin-Bicêtre, France

name: 2Hôpital de Cayenne, Service d’Endocrinologie et des Maladies Métaboliques, Cayenne, Guyane Française

family: Sabbah

full_name: Nadia Sabbah

given: Nadia

name: 3Division of Endocrinology and Metabolism, Department of Internal Medicine III, Medical University of Vienna, Vienna, Austria

family: Wolf

full_name: Peter Wolf

given: Peter

name: 4Assistance Publique-Hôpitaux de Paris, Hôpital de Bicêtre, Unité de Recherche Clinique, Le Kremlin-Bicêtre, France

family: Piedvache

full_name: Céline Piedvache

given: Céline

name: 5Université Paris-Saclay, Inserm, Physiologie et Physiopathologie Endocriniennes, Assistance Publique-Hôpitaux de Paris, Hôpital de Bicêtre, Service de Génétique Moléculaire, Pharmacogénétique et Hormonologie, Le Kremlin-Bicêtre, France

family: Trabado

full_name: Séverine Trabado

given: Séverine

family: Verdelet

full_name: Tristan Verdelet

given: Tristan

name: 6Centre d’Investigation Clinique, INSERM CIC1407/UMR5558, Hospices Civils de Lyon, Bron, France

family: Cornu

full_name: Catherine Cornu

given: Catherine

name: 7Assistance Publique-Hôpitaux de Paris, Hôpital Necker, Service d’Explorations Fonctionnelles, Paris, France

family: Souberbielle

full_name: Jean-Claude Souberbielle

given: Jean-Claude

family: Chanson

full_name: Philippe Chanson

journal_name: Endocrine Connections

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

publisher: Bioscientifica

publisher_dissemination: Bioscientifica

publisher_group: Bioscientifica

publisher_normalized: Bioscientifica

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

family: Loeb

full_name: E. Loeb

given: E.

family: Becquemont

full_name: L. Becquemont

given: L.

family: Corruble

full_name: E. Corruble

journal_name: Psychopharmacology

title: Is the decrease in NOx due to a lack of substrate or a NOS inhibition in patients with major depression?

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

name: Department of Rheumatology, Hôpitaux Universitaires Paris-Sud, Assistance Publique–Hôpitaux de Paris (AP-HP), Université Paris-Sud, INSERM UMR1184, Le Kremlin Bicêtre

family: Mariette

full_name: Xavier Mariette

given: Xavier

name: Department of Epidemiology, Université Paris-Descartes, Paris

family: Perrodeau

full_name: Elodie Perrodeau

given: Elodie

name: Department of Periodontology, University of Nantes, Nantes

family: Verner

full_name: Christian Verner

given: Christian

name: INSERM, UMR-S 1229, RMeS, Faculty of Dental Surgery, University of Nantes, Nantes

family: Struillou

full_name: Xavier Struillou

name: Department of Rheumatology, Université de Bordeaux, Bordeaux

name: Department of Rheumatology, Hôpital Pierre-Paul Riquet and Université Toulouse III - Paul Sabatier, Toulouse

name: Department of Periodontology, Service of Odontology, Rothschild Hospital, AP-HP, Denis Diderot University

name: EA 2496, Paris 5-Descartes University, U.F.R. of Odontology, Paris, France

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

name: Service d’Endocrinologie et des Maladies de la Reproduction and Centre de Référence des Maladies Rares de l'Hypophyse, F94275 Le Kremlin-Bicêtre, France

name: Inserm 1185, Fac Med Paris Sud, Université Paris-Saclay, F94276 Le Kremlin-Bicêtre, France

name: Assistance Publique-Hôpitaux de Paris, Hôpitaux Universitaires Paris-Sud, Hôpital de Bicêtre, Unité de Recherche Clinique, F94275 Le Kremlin-Bicêtre, France

name: Service de Génétique Moléculaire, Pharmacogénétique et Hormonologie, F94275 Le Kremlin-Bicêtre, France

name: Laboratoire d’Hormonologie, Centre Hospitalier Universitaire de Rennes, Centre d’Investigation Clinique Plurithématique, Inserm 1414, Hôpital Pontchaillou, F29000 Rennes, France

name: Service des Explorations Fonctionnelles, Assistance Publique-Hôpitaux de Paris, Hôpital Necker-Enfants Malades, F75015 Paris, France

journal_name: The Journal of Clinical Endocrinology & Metabolism

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Archive ouverte HAL

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

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

name: Service d'Endocrinologie et des Maladies de la Reproduction and Centre de Référence des Maladies Endocriniennes Rares de la Croissance (P.C., M.M., J.Y.), Le Kremlin-Bicêtre, F94275, France

name: Inserm 1185 (P.C., S.B.T., J.Y.), Fac Med Paris Sud, Université Paris-Saclay, Le Kremlin-Bicêtre, F-94276, France

name: Unité de Recherche Clinique (A.A.), Le Kremlin-Bicêtre, F94275, France

name: Service de Génétique Moléculaire, Pharmacogénétique et Hormonologie (S.B.T.), Assistance Publique-Hôpitaux de Paris, Hôpitaux Universitaires Paris-Sud, Hôpital de Bicêtre, Le Kremlin-Bicêtre, F94275, France

name: Laboratoire d'Hormonologie (C.M.), Centre Hospitalier Universitaire de Rennes, Centre d'Investigation Clinique Plurithématique, Inserm 1414, Hôpital Pontchaillou, Rennes, F29000, France

name: Service des Explorations Fonctionnelles (M-L.P., J.-C.S.), Assistance Publique-Hôpitaux de Paris, Hôpital Necker-Enfants Malades, Paris, F75015, France

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

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


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

acronym: BALNEORESPI

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

lead_sponsor: Centre d'Investigation Clinique et Technologique 805