acronym: PAKT

title: A Phase II, Double-blind, Randomised, Placebo-controlled Study of the AKT Inhibitor AZD5363 in Combination With Paclitaxel in Triple-Negative Advanced or Metastatic Breast Cancer (PAKT).

lead_sponsor: Queen Mary University of London

ReferenceCitation: Schmid P, Abraham J, Chan S, Wheatley D, Brunt AM, Nemsadze G, Baird RD, Park YH, Hall PS, Perren T, Stein RC, Mangel L, Ferrero JM, Phillips M, Conibear J, Cortes J, Foxley A, de Bruin EC, McEwen R, Stetson D, Dougherty B, Sarker SJ, Prendergast A, McLaughlin-Callan M, Burgess M, Lawrence C, Cartwright H, Mousa K, Turner NC. Capivasertib Plus Paclitaxel Versus Placebo Plus Paclitaxel As First-Line Therapy for Metastatic Triple-Negative Breast Cancer: The PAKT Trial. J Clin Oncol. 2020 Feb 10;38(5):423-433. doi: 10.1200/JCO.19.00368. Epub 2019 Dec 16.

location_country:
United Kingdom
Georgia
Hungary
Korea, Republic of
France
Romania

location_facility: Abertawe Bro Margannwg University Health Board

location_facility: Glan Clwyd Hospital BCU Health Board NHS Wales

location_facility: East Kent Hospitals University NHS Foundation Trust

location_facility: University of Pécs - Clinical Center Institute of Oncotherapy

location_facility: Nottingham University Hospitals NHS Trust

location_facility: University Hospitals Coventry and Warwickshire NHs Trust

location_facility: Brighton and Sussex University Hospitals NHS Trust

location_facility: Cambridge University Hospitals NHS Foundation Trust

location_facility: Barking, Havering and Redbridge University Hospitals NHS Trust

location_facility: Royal Marsden NHS Foundation Trust-Fulham

location_facility: Guys and St Thomas' NHS Foundation Trust

location_facility: Sf. Nectarie SRL Oncologie Medical Center

location_facility: Southend University Hospital NHS Foundation Trust

location_facility: Southampton University Hospitals NHS Trust

location_facility: Yeovil District Hospital NHS Foundation Trust

location_facility: Prof. Dr. I. Chiricuta Oncology Institute

location_facility: University Hospital of North Staffordshire NHS Trust

summary:
PAKT was an investigator-led, placebo-controlled, randomized phase II trial performed in 42 academic medical centers in the United Kindom, South Korea, France, Hungary, Romania, and Georgia. Patients were randomly assigned (1:1) to receive paclitaxel plus capivasertib or paclitaxel plus placebo. Stratification was by number of metastatic sites (< 3 v ≥ 3) and interval from the end of prior adjuvant or neoadjuvant chemotherapy (≤ 12 v > 12 months v no prior chemotherapy).

Paclitaxel was administered as a once-per-week intravenous infusion of 90 mg/m2 over approximately 1 hour on days 1, 8, and 15 of each 28-day treatment cycle. Capivasertib 400 mg or placebo was administered orally twice per day on an intermittent weekly dosing schedule, with treatment on days 2 to 5 of weeks 1, 2, and 3 within each 28-day cycle. All treatments were continued until disease progression, development of unacceptable toxicity, or withdrawal of consent. If paclitaxel treatment was discontinued before disease progression, patients could continue to receive capivasertib or placebo alone. In case of adverse events (AEs), capivasertib or placebo could be reduced to 320 mg twice per day and subsequently to 240 mg twice per day. Capivasertib or placebo could be interrupted for up to 4 weeks for toxicity.

Tumor assessments included computed tomography scanning or magnetic resonance imaging of the chest, abdomen, and pelvis at baseline, every 8 weeks during treatment, and at progression. Patients who discontinued treatment for any reason other than progression were required to follow the same schedule of assessments until progression, initiation of another treatment, death, or withdrawal of consent.


title: A Simple Blind Controlled Randomized Trial: Cephalic Version by Acupuncture-moxibustion vs Placebo for Breech Presentation

acronym: ACUVERSE

summary: For breech presentation, the cesarean section rate is decreased by external cephalic version. This is a painful operation, with some rare but serious complications. The aim of this trial is to evaluate the effectiveness of acupuncture-moxibustion, a non-invasive technique, to correct breech presentation before 37 weeks of gestation.

status: Completed

study_completion_date_type: Actual

study_type: Interventional

design_allocation: Randomized

enrollment_type: Actual

ReferenceType: derived

ReferenceCitation: Coulon C, Poleszczuk M, Paty-Montaigne MH, Gascard C, Gay C, Houfflin-Debarge V, Subtil D. Version of breech fetuses by moxibustion with acupuncture: a randomized controlled trial. Obstet Gynecol. 2014 Jul;124(1):32-39. doi: 10.1097/AOG.0000000000000303.

lead_sponsor: University Hospital, Lille

location_facility: Hopital Jeanne de Flandre, CHRU de Lille

intervention_type: Other

lead_sponsor_type: academique

status_simplified: Completed


title: Assessment of 18Fluoro-thymidine PET-CT for the Volume Definition of High-grade Gliomas (GLIO-TEP) : Correlation With Histopathology

acronym: GLIO-TEP

summary: 18F-Fluorothymidine is a recently developed PET tracer to image tumor cell proliferation. Very few data report an interest of using such a tracer for cerebral malignant tumor management. In our project, we want to compare the tumoral volumes obtained with PET and MRI, with the gold standard histopathological diagnosis according to the WHO grading malignancy scale and the Ki-67 proliferation index, for preoperative evaluation as much as for tumoral postoperative residue evaluation. Furthermore, we want to explore the interest of 18F-FLT-PET volume to better delineate tumoral volume in radiotherapeutic management of gliomas.

design_allocation: Non-Randomized

primary_purpose: Diagnostic

ReferenceType: background

ReferenceCitation: Choi SJ, Kim JS, Kim JH, Oh SJ, Lee JG, Kim CJ, Ra YS, Yeo JS, Ryu JS, Moon DH. [18F]3'-deoxy-3'-fluorothymidine PET for the diagnosis and grading of brain tumors. Eur J Nucl Med Mol Imaging. 2005 Jun;32(6):653-9. Epub 2005 Feb 15.

ReferenceCitation: Chen W, Cloughesy T, Kamdar N, Satyamurthy N, Bergsneider M, Liau L, Mischel P, Czernin J, Phelps ME, Silverman DH. Imaging proliferation in brain tumors with 18F-FLT PET: comparison with 18F-FDG. J Nucl Med. 2005 Jun;46(6):945-52.

lead_sponsor: University Hospital, Bordeaux

location_facility: Hôpital Pellegrin-tripode , CHU de Bordeaux

intervention_type: Radiation


title: Digital Preop-planning of Total Hip Arthroplasties in Orthopedic

acronym: PLANORTHO

summary: Residual leg length discrepancy is a common issue after total hip arthroplasty(THA). Digital preoperative planning may improve the accuracy of the surgical procedure and may help the surgeon to precisely predict implants sizes

study_start_date_type: Actual

status: Unknown status

study_completion_date_type: Anticipated

primary_purpose: Treatment

enrollment_type: Anticipated

ipd_sharing: No

lead_sponsor: University Hospital, Toulouse

intervention_type: Device

status_simplified: Unknown


title: Evaluating Efficacy and Safety of Medium-chain Triglycerides Used as a Temporary Intraocular Tamponading Agent for Retinal Detachment Treated by Endocular Surgery

acronym: MCT

summary:
Background : Surgery is needed in order to flatten and position a detached retina onto the choroid, to allow sealing of the tears and to prevent or reverse vision loss. In case of complex retinal detachment vitrectomies followed by ocular endotamponade - non-solid implants used in ophthalmology - is the most common treatment. Despite several options used by surgeons were not entirely satisfactory, no innovation were marketed in the ocular endotamponade field since decades.

Purpose : Regarding comparative physico-chemical properties of medium-chain triglycerides (MCT) with current tamponading agents (silicone oil or gases), it will be proposed to evaluate the MCT as an ocular endotamponade product.

location_facility: University Hospital Toulouse (Hospital Pierre Paul Riquet)


title: Needle-based Confocal Laser Endomicroscopy in CT-guided Procedures in Interventional Radiology With Applications in Liver and Kidneys: a Feasibility Study

summary:
This study is a prospective study in order to demonstrate the technical feasibility and safety of doing endomicroscopic imaging during interventional radiology procedure in two main indications: Kidneys and liver.

This innovative study will involve the use of probe-based confocal laser endomicroscopy. The proposed study is a feasibility study.

lead_sponsor: Mauna Kea Technologies

lead_sponsor_type: industriel


title: Validation of a Tool for the Dimensional Assessment of Apathy in a Population Suffering From Schizophrenia.

summary:
Schizophrenia affects about 1% of the world's population. According to the WHO, it was one of the ten most worrying pathologies of the twenty-first century. The situation of psychic disability that results impacted the entire life course. This disease is characterized by positive symptoms (delirium, hallucination, psychotic agitation) and negative symptoms and disorganization (destructuring of thought, language and behavior). Cognitive disorders are easily measurable in the spectrum of schizophrenia and are quantifiable with some tools to measure the level of performance of the individual in different areas.

In these patients apathy is found in one out of two cases (prevalence of 51%), so it is a widespread negative symptom. Apathy corresponds to a pathology of voluntary action that can exist in different forms, resulting from the alteration of one or more mechanisms. It is a predictor of functional outcomes, regardless of positive symptoms or depression.

Studies of people with head injuries have found a link between frontal cognitive impairment and apathy. The recognition, the identification of the dimensional mechanisms of apathy and the understanding of the links with cognitive disorders are therefore a major issue in the improvement of the functional prognosis. Moreover, these mechanisms are currently little studied in the spectrum of schizophrenia.

There are currently questionnaires to show the presence or absence of apathy, such as the Apathy Evaluation Scale or the Lille Apathy Rating Scale. However most scales offer a global apathy score and the proposed treatments are limited due to the difficulty in identifying the dimensions and understanding of the underlying mechanisms of their own.

The potentiality of apathy to become a source of disability is now widely recognized. It is therefore important to consider the expression of this handicap in terms of the repercussions that this disorder may have on the daily lives of patients. There are questionnaires to measure the functional autonomy of patients with a psychic disorder. Apathy is also an obstacle to supporting patients in psychiatry.

The lack of knowledge and underestimation of apathy and its mechanisms in schizophrenia, in addition to overworking the psychiatric health sector, favor a drift towards the institutionalization of the person, with its medico-economic consequences on the system.

lead_sponsor: Centre Hospitalier de Niort

location_facility:
Centre Hospitalier Esquirol
Centre Hospitalier de Niort

intervention_type: Diagnostic Test


type: Registry Identifier

title: Cost-utility, Safety and Feasibility of Ambulatory Surgery Versus Traditional Pathway in the Management of Endometrial Cancer: a Multicentre, Prospective and Randomised Study

acronym: AMBU-ENDO

summary:
To date, cost-utility, safety, and feasibility of ambulatory surgery versus traditional pathway in the management of endometrial cancer have never been prospectively assessed.

The investigators hypothesize that ambulatory surgery versus standard pathway in the management of endometrial cancer is both safe, feasible and may impact on patient health-related quality of life.

The main objective of the study is to assess the cost-utility of ambulatory surgery versus standard pathway in the management of endometrial cancer.

A total of 252 consecutive, eligible, consenting patients with a low- and intermediate-risk early stage endometrial cancer will be enrolled from various clinical practice sites within France and patient will randomly be assigned to one of the two surgical management pathways: ambulatory pathway versus standard pathway.

status: Recruiting

lead_sponsor: Assistance Publique - Hôpitaux de Paris

location_facility: Hôpital Bichat-Claude Bernard Gynécologie obstétrique

location_facility: Service de Chirurgie Gynécologique Obstétrique Reproduction Humaine

location_facility: HEGP - Chirurgie Cancérologique Gynécologique et du Sein

location_facility: Service de chirurgie gynécologique, hôpital Tenon

location_facility: Service de chirurgie gynécologique, hôpital Pitié-salpêtrière

location_facility: Service de chirurgie gynécologique, Centre Hospitalier Simone Veil

location_facility: Service de chirurgie gynécologique, Centre de lutte contre le cancer

intervention_type: Procedure

status_simplified: Ongoing


type: Other Identifier

title: Relevance of a Web-mediated Follow up in Patients Having a Lymphoma With a High Risk of Relapse in Complete or Partial Response

summary:
Lymphoma is the 6th cancer in terms of incidence in France where approximately 11,000 new cases are diagnosed each year. Most types of lymphomas occur at all ages with a predominance in elderly subjects.

With the continuous improvement of the diagnostic techniques and the treatments, the prognosis of lymphomas is constantly improving. However, 20-40% of patients relapse most often within 2 or 3 years after the end of treatment.

The current standard follow up includes a clinical examination and a biological check-up every 3 months for 2 years, then every 6 months up to 5 years and an imaging every 6 months. However, the interest of this systematic surveillance by imaging is controversial.

The use of new information and communication technologies, can improve the clinical follow-up of patients. To date, access to the Internet and portable technologies is sufficiently broad and democratized to envisage the use of this type of remote surveillance in the field of health. In particular to facilitate the dissemination of information between the patient and the physician. It is thus possible to imagine using this flow of information to generate alerts.

Strengthening the clinical follow-up in this indication, in which routine imaging has not demonstrated their interest, in particular by the implementation of remote monitoring completed by the patient, may present an advantage in terms of effectiveness and precocity of care. In this pathology, up to 40% of patients relapse early (within 2 to 3 years), in the vast majority of cases symptomatically (less than 2% asymptomatic relapse discovered by imaging). Finally the CT scan every 6-month , which generates radiation costs and exposures for a relatively low benefit, is performed in symptomatic patients since several weeks.

The aim of this study is to evaluate the interest of a web-mediated follow up using a score based on the dynamics and the association of clinical and biological signs to alert the physician of a possible recurrence of the patients treated for a lymphoma in complete or partial response.

status: Terminated

lead_sponsor: Weprom

location_facility: Institut d'Hématologie de Basse Normandie

location_facility: Centre Hospitalier Universitaire Jean Minjoz


type: Other Grant/Funding Number

title: Effet d'Une supplémentation Avec Une Nouvelle préparation hyperprotéinée et Hypercalorique Sur l'évolution Des paramètres Fonctionnels, Nutritionnels et Cognitifs Chez la Personne âgée en Institution

summary: The objective of this study is to determine whether a supplementation with a new high-protein oral supplement can improve the evolution of functional parameters in elderly patients in nursing homes.

primary_purpose: Supportive Care

lead_sponsor: Lactalis

intervention_type: Dietary Supplement


title: Influence of the Administration of DAV132 7.5g Tid for 7 Days on the Fecal Levels of Moxifloxacin During and After a 5-day Oral Treatment With Moxifloxacin 400mg Oad in Healthy Volunteers

summary: The purpose of this study is to determine whether DAV132 is safe and effective for capturing fecal residues of moxifloxacin in healthy volunteers.

primary_purpose: Prevention

ReferenceCitation: Edlund C, Beyer G, Hiemer-Bau M, Ziege S, Lode H, Nord CE. Comparative effects of moxifloxacin and clarithromycin on the normal intestinal microflora. Scand J Infect Dis. 2000;32(1):81-5.

ReferenceCitation: Burkhardt O, Borner K, Stass H, Beyer G, Allewelt M, Nord CE, Lode H. Single- and multiple-dose pharmacokinetics of oral moxifloxacin and clarithromycin, and concentrations in serum, saliva and faeces. Scand J Infect Dis. 2002;34(12):898-903.

ReferenceCitation: de Gunzburg J, Ghozlane A, Ducher A, Le Chatelier E, Duval X, Ruppé E, Armand-Lefevre L, Sablier-Gallis F, Burdet C, Alavoine L, Chachaty E, Augustin V, Varastet M, Levenez F, Kennedy S, Pons N, Mentré F, Andremont A. Protection of the Human Gut Microbiome From Antibiotics. J Infect Dis. 2018 Jan 30;217(4):628-636. doi: 10.1093/infdis/jix604.

lead_sponsor: Da Volterra

location_facility: CLINICAL INVESTIGATION CENTER (CIC), Groupe Hospitalier Bichat-Claude Bernard


acronym: CAPARFI

summary:
Sarcopenia is known to be associated with loss in muscle mass that results from a reduced number of muscle fibres, an atrophy of remaining muscle fibres, and an increased infiltration of non-contractile tissue (collagen, fat). Accentuated by cancer and treatments, sarcopenia impairs muscle function resulting in a higher risk of physical disability and death. The commonly used test for sarcopenia screening consists in a DEXA (Dual energy X-ray absorptiometry) scan. However, this test can't provide structural muscle information. In contrast, the mechanical properties of muscle tissue can be explored using an acoustic radiation force impulse (ARFI). The question remains whether muscle sonoelastography using ARFI imaging could be helpful for sarcopenia screening.

For this, volunteers will be recruited in three groups: ≤ 30 years (Gr A) and ≥ 70years, both without any serious chronic disease, and patients ≥ 70 years presenting curative cares for cancer (Gr C).

The volunteers belonging to the groups A and B will be followed during one day. The patients included in the group C will be followed during 6 months. For this latter group; the first visit (t0) will take place before treatment and the second visit will take place 6 months later (t6months) Volunteers will have clinical examinations (weight, stature, BMI, performance status/ ECOG) and will be evaluated on their nutritional status (MNA-SF, 24h dietary recall) and physical capacities (IPAQ, SPPB, lower limb muscle strength, 6-min walk test, QLQ-C30 items relative to the fatigue symptom).

location_facility:
CHU de Bordeaux - Hôpital Haut-Lévêque
CHU Bordeaux - Hôpital Saint André


title: Etude de Recherche de Dose de l'Association Irinotecan (Campto(R)) - Cisplatine (Cisplatyl(R)) Avec la radiothérapie Pelvienne Dans Les Cancers avancés du Col de l'utérus.

summary: Search of maximum tolerated irinotecan dose in association with cisplatin and pelvic radiotherapy in patients with an advanced cervix cancer.

lead_sponsor: ARCAGY/ GINECO GROUP

location_facility:
CRLC Val d'Aurelle
Centre Claudius Régaud

intervention_type: Drug


title: Lymphocyte Reconstitution in a Randomized Study After Administration of Pegfilgrastim Versus Filgrastim in Patients With B-cell Non-Hodgkin Lymphoma Treated With High-dose Chemotherapy and Autologous Peripheral Stem Cell Transplantation

summary: The purpose of this study is to describe the kinetics of lymphocyte subsets reconstitution after growth factor administration, Pegfilgrastim versus Filgrastim in patients with B-cell malignant non-Hodgkin lymphoma treated with high-dose chemotherapy and autologous peripheral stem cell transplantation.

ReferenceCitation: Dieckmann D, Plottner H, Berchtold S, Berger T, Schuler G. Ex vivo isolation and characterization of CD4(+)CD25(+) T cells with regulatory properties from human blood. J Exp Med. 2001 Jun 4;193(11):1303-10.

ReferenceCitation: Goguel AF, Crainic K, Ducailar A, Ouin M. Interlaboratory quality assessment of lymphocyte phenotyping. Etalonorme 1990-1992 surveys. Biol Cell. 1993;78(1-2):79-84.

ReferenceCitation: Holmes FA, Jones SE, O'Shaughnessy J, Vukelja S, George T, Savin M, Richards D, Glaspy J, Meza L, Cohen G, Dhami M, Budman DR, Hackett J, Brassard M, Yang BB, Liang BC. Comparable efficacy and safety profiles of once-per-cycle pegfilgrastim and daily injection filgrastim in chemotherapy-induced neutropenia: a multicenter dose-finding study in women with breast cancer. Ann Oncol. 2002 Jun;13(6):903-9.

ReferenceCitation: Holmes FA, O'Shaughnessy JA, Vukelja S, Jones SE, Shogan J, Savin M, Glaspy J, Moore M, Meza L, Wiznitzer I, Neumann TA, Hill LR, Liang BC. Blinded, randomized, multicenter study to evaluate single administration pegfilgrastim once per cycle versus daily filgrastim as an adjunct to chemotherapy in patients with high-risk stage II or stage III/IV breast cancer. J Clin Oncol. 2002 Feb 1;20(3):727-31.

ReferenceCitation: Joao C, Porrata LF, Inwards DJ, Ansell SM, Micallef IN, Johnston PB, Gastineau DA, Markovic SN. Early lymphocyte recovery after autologous stem cell transplantation predicts superior survival in mantle-cell lymphoma. Bone Marrow Transplant. 2006 May;37(9):865-71.

ReferenceCitation: Jonuleit H, Schmitt E, Stassen M, Tuettenberg A, Knop J, Enk AH. Identification and functional characterization of human CD4(+)CD25(+) T cells with regulatory properties isolated from peripheral blood. J Exp Med. 2001 Jun 4;193(11):1285-94.

ReferenceCitation: Noether, G. E. Sample size determination for some common nonparametric statistics. Journal of the American Statistical Association 82 : 645-47, 1987.

ReferenceCitation: Peggs KS. Immune reconstitution following stem cell transplantation. Leuk Lymphoma. 2004 Jun;45(6):1093-101. Review.

ReferenceCitation: Porrata LF, Gertz MA, Inwards DJ, Litzow MR, Lacy MQ, Tefferi A, Gastineau DA, Dispenzieri A, Ansell SM, Micallef IN, Geyer SM, Markovic SN. Early lymphocyte recovery predicts superior survival after autologous hematopoietic stem cell transplantation in multiple myeloma or non-Hodgkin lymphoma. Blood. 2001 Aug 1;98(3):579-85.

ReferenceCitation: Porrata LF, Inwards DJ, Ansell SM, Micallef IN, Johnston PB, Gastineau DA, Litzow MR, Winters JL, Markovic SN. Early lymphocyte recovery predicts superior survival after autologous stem cell transplantation in non-Hodgkin lymphoma: a prospective study. Biol Blood Marrow Transplant. 2008 Jul;14(7):807-16. doi: 10.1016/j.bbmt.2008.04.013.

ReferenceCitation: Porrata LF, Inwards DJ, Micallef IN, Ansell SM, Geyer SM, Markovic SN. Early lymphocyte recovery post-autologous haematopoietic stem cell transplantation is associated with better survival in Hodgkin's disease. Br J Haematol. 2002 Jun;117(3):629-33.

ReferenceCitation: Reimer P, Kunzmann V, Wilhelm M, Weissbrich B, Kraemer D, Berghammer H, Weissinger F. Cellular and humoral immune reconstitution after autologous peripheral blood stem cell transplantation (PBSCT). Ann Hematol. 2003 May;82(5):263-70. Epub 2003 Mar 22.

ReferenceCitation: Roberts MM, To LB, Gillis D, Mundy J, Rawling C, Ng K, Juttner CA. Immune reconstitution following peripheral blood stem cell transplantation, autologous bone marrow transplantation and allogeneic bone marrow transplantation. Bone Marrow Transplant. 1993 Nov;12(5):469-75.

ReferenceCitation: Sebban C, Lefranc A, Perrier L, Moreau P, Espinouse D, Schmidt A, Kammoun L, Ghesquieres H, Ferlay C, Bay JO, Lissandre S, Pérol D, Michallet M, Quittet P. A randomised phase II study of the efficacy, safety and cost-effectiveness of pegfilgrastim and filgrastim after autologous stem cell transplant for lymphoma and myeloma (PALM study). Eur J Cancer. 2012 Mar;48(5):713-20. doi: 10.1016/j.ejca.2011.12.016. Epub 2012 Jan 14.

ReferenceCitation: Shimizu J, Yamazaki S, Sakaguchi S. Induction of tumor immunity by removing CD25+CD4+ T cells: a common basis between tumor immunity and autoimmunity. J Immunol. 1999 Nov 15;163(10):5211-8.

ReferenceCitation: Singh RK, Ino K, Varney ML, Heimann DG, Talmadge JE. Immunoregulatory cytokines in bone marrow and peripheral blood stem cell products. Bone Marrow Transplant. 1999 Jan;23(1):53-62.

ReferenceCitation: Talmadge JE, Reed E, Ino K, Kessinger A, Kuszynski C, Heimann D, Varney M, Jackson J, Vose JM, Bierman PJ. Rapid immunologic reconstitution following transplantation with mobilized peripheral blood stem cells as compared to bone marrow. Bone Marrow Transplant. 1997 Jan;19(2):161-72.

ReferenceCitation: Thornton AM, Shevach EM. Suppressor effector function of CD4+CD25+ immunoregulatory T cells is antigen nonspecific. J Immunol. 2000 Jan 1;164(1):183-90.

ReferenceCitation: Vanstraelen G, Frère P, Ngirabacu MC, Willems E, Fillet G, Beguin Y. Pegfilgrastim compared with Filgrastim after autologous hematopoietic peripheral blood stem cell transplantation. Exp Hematol. 2006 Mar;34(3):382-8.

ReferenceCitation: Woo EY, Chu CS, Goletz TJ, Schlienger K, Yeh H, Coukos G, Rubin SC, Kaiser LR, June CH. Regulatory CD4(+)CD25(+) T cells in tumors from patients with early-stage non-small cell lung cancer and late-stage ovarian cancer. Cancer Res. 2001 Jun 15;61(12):4766-72.

lead_sponsor: Centre Leon Berard

location_facility:
Centre Leon Berard
CHU Clermont-Ferrand, Hôpital d'Estaing


title: ARNS 141 TIPI : A Pilot Trial to Assess the Ability of an Intermittent Antiretroviral Therapy in Maintaining an Immunological Stability in Antiretroviral naïve HIV Infected Adults, With CD4 Count Above 500/mm3

acronym: TIPI

summary: The primary objective of the trial is to assess the ability of an early and intermittent antiretroviral therapy in maintaining an immunological stability in antiretroviral naive HIV infected adults, to offer a potential alternative strategy to differed and continuous antiretroviral treatment.This is a 2-year phase II, open-label, multicentric "proof of concept" trial. The patients included are treated following a pulse-therapy scheme, i.e. 6-month periods with once daily boosted-PI based therapy in alternance with 6-month periods without antiretroviral therapy. The preferentially recommended treatment of the study is atazanavir boosted with ritonavir, associated with a fixed combination of abacavir and lamivudine or emtricitabine + tenofovir.The patients are closely followed to assess the efficacy and the tolerance of the strategy, with clinical, biochemical, immunological, virological and pharmacokinetic evaluations.

ReferenceCitation: Piroth L, Moinot L, Yeni P, Avettand-Fénoel V, Reynes J, Girard PM, Marchou B, Georget A, Rouzioux C, Autran B, Duvillard L, Chêne G, Fagard C; ANRS 141 TIPI Trial Study Group. Immunity, inflammation and reservoir in patients at an early stage of HIV infection on intermittent ART (ANRS 141 TIPI Trial). J Antimicrob Chemother. 2016 Feb;71(2):490-6. doi: 10.1093/jac/dkv369. Epub 2015 Nov 14.

lead_sponsor: ANRS, Emerging Infectious Diseases

location_facility: Services maladies infectieuses et tropicales CHU


title: Six- Versus Twelve-Week Therapy for Non-Surgically-Treated Diabetic Foot Osteomyelitis: A Multicenter Open-Label Controlled Randomized Study

acronym: C H R O N O S

summary: The purpose of the study is to compare the efficacy and tolerance of 6- versus 12-week antibiotic therapy in patients with diabetic foot osteomyelitis treated medically.

ReferenceCitation: Tone A, Nguyen S, Devemy F, Topolinski H, Valette M, Cazaubiel M, Fayard A, Beltrand É, Lemaire C, Senneville É. Six-week versus twelve-week antibiotic therapy for nonsurgically treated diabetic foot osteomyelitis: a multicenter open-label controlled randomized study. Diabetes Care. 2015 Feb;38(2):302-7. doi: 10.2337/dc14-1514. Epub 2014 Nov 20. Erratum in: Diabetes Care. 2015 Apr;38(4):735.

lead_sponsor: Tourcoing Hospital


title: Multimodal MRI-guided Repetitive Transcranial Magnetic Stimulation to Treat Drug-resistant Hallucinations: a Randomized Control Trial

acronym: MULTIMODHAL

summary:
The efficacy of neuro-navigated rTMS for patients with schizophrenia suffering from drug-resistant multisensory hallucinations will be tested by the implementation of a double-blind randomized controlled trial (RCT)
This study will use a combination of different MRI modalities (fMRI and DTI) to define with precision rTMS brain-targets in the case of multisensory hallucinations
The investigators anticipate that multimodal MRI-guided rTMS will allow a significant improvement in the efficacy of neuromodulation treatment of refractory hallucinations

ReferenceCitation: Leroy A, Foucher JR, Pins D, Delmaire C, Thomas P, Roser MM, Lefebvre S, Amad A, Fovet T, Jaafari N, Jardri R. fMRI capture of auditory hallucinations: Validation of the two-steps method. Hum Brain Mapp. 2017 Oct;38(10):4966-4979. doi: 10.1002/hbm.23707. Epub 2017 Jun 28.

location_facility:
Lille University Hospital Centre
Saint-Anne Psychiatric Hospital


title: Opothérapie Par Hydrocortisone après Injection Unique d'Etomidate Chez le Patient de réanimation

summary: the objective of the study is to assess the value of substitution with 200mg/24h of hydrocortisone for 48 hours for patients in intensive care who have received a single injection of etomidate

ReferenceCitation: Payen JF, Dupuis C, Trouve-Buisson T, Vinclair M, Broux C, Bouzat P, Genty C, Monneret D, Faure P, Chabre O, Bosson JL. Corticosteroid after etomidate in critically ill patients: a randomized controlled trial. Crit Care Med. 2012 Jan;40(1):29-35. doi: 10.1097/CCM.0b013e31822d7938.

lead_sponsor: University Hospital, Grenoble

location_facility: Réanimation polyvalente déchocage, centre hospitalier de la région Annecienne

location_facility: Pôle d'anesthésie - réanimation, University Hospital of Grenoble


title: A First in Human Phase I Study of INVAC-1 as a Single Agent in Patients With Advanced Cancer

summary: INVAC-1 is intended to be used for the treatment of adult patients with advanced solid tumors unresponsive to currently available therapies, or for whom no standard therapy is available.

ReferenceCitation: Teixeira L, Medioni J, Garibal J, Adotevi O, Doucet L, Durey MD, Ghrieb Z, Kiladjian JJ, Brizard M, Laheurte C, Wehbe M, Pliquet E, Escande M, Defrance R, Culine S, Oudard S, Wain-Hobson S, Doppler V, Huet T, Langlade-Demoyen P. A First-in-Human Phase I Study of INVAC-1, an Optimized Human Telomerase DNA Vaccine in Patients with Advanced Solid Tumors. Clin Cancer Res. 2020 Feb 1;26(3):588-597. doi: 10.1158/1078-0432.CCR-19-1614. Epub 2019 Sep 26.

lead_sponsor: Invectys

location_facility:
Hôpital Saint Louis
Hôpital Européen Georges Pompidou

intervention_type: Biological


title: Phase II Randomised Clinical Trial Evaluating an EGFR Tyrosine Kinase Inhibitor (EGFR-TKI) Versus an EGFR-TKI Combined With an Anti-oestrogen Treatment (Fulvestrant) in Women With Advanced Stage Non-squamous Lung Cancer

acronym: LADIE

summary:
Lung Cancer is to become the first cause of death related to cancer in France as it's already the case in United States. At Present, Lung Cancer in women and in men is treated similarly. Nevertheless, numerous studies shows that lung cancer in women has specificities : at the time of the diagnosis female patients are younger, there are less clinical signs, clinical stages are earlier, histology is often adenocarcinoma. The link with tabagism is weaker . Sensitivity to tabagism is higher (more cancer in women with the same tabagism). Response rate to chemotherapy is better. Prognosis is better

Numerous hypotheses have been put forward to account for the specific characteristics of female lung cancer described above.

One hypothesis is that there are different genetic anomalies in women. Some studies show an increase of EGFR mutation and HER2 expression and a decrease of expression of repair enzymes (ERCC1, RRM1, BRCA) which can explain the increase sensitivity to tabagism and to chemotherapy.
Another hypothesis is that hormones play a role in oncogenesis. Indeed, lung cancer presents hormonal risk factors : pre-menopause, less than 3 kids, short menstrual cycle, hormone replacement therapy. Estrogens would have a deleterious effect on cancer incidence and on survival of lung cancer in women. Cellular and animal models show that ER pathway is activated in lung cancer and participates in oncogenesis.
Moreover an interaction between RE and EGFR pathway has been demonstrated on lung cancer cell lines and mouse models.

EGFR-TKI have shown benefit in women with wild type EGFR or unknown status (with erlotinib) and in women with EGFR mutations (with gefitinib). In this study, the use of these two treatment will be in accordance with their market authorisations.

The objective of this study is to test the addition of an anti-estrogen (fulvestrant) to EGFR-TKI. Fulvestrant is a pure anti-oestrogen that binds to ER, blocks it and accelerates its breakdown. It has a market authorisation in breast cancer. Furthermore the association between EGFR-TKI and anti-estrogen could have a synergetic effect due to interaction between RE and EGFR pathways .

ReferenceCitation: Mazieres J, Barlesi F, Rouquette I, Molinier O, Besse B, Monnet I, Audigier-Valette C, Toffart AC, Renault PA, Fraboulet S, Hiret S, Mennecier B, Debieuvre D, Westeel V, Masson P, Madroszyk-Flandin A, Pichon E, Cortot AB, Amour E, Morin F, Zalcman G, Moro-Sibilot D, Souquet PJ. Randomized Phase II Trial Evaluating Treatment with EGFR-TKI Associated with Antiestrogen in Women with Nonsquamous Advanced-Stage NSCLC: IFCT-1003 LADIE Trial. Clin Cancer Res. 2020 Jul 1;26(13):3172-3181. doi: 10.1158/1078-0432.CCR-19-3056. Epub 2020 Mar 6.

lead_sponsor: Intergroupe Francophone de Cancerologie Thoracique

location_facility: Hôpital Nord - Oncologie Multidisciplinaire & Innovations Thérapeutiques


title: Placebo-controlled Evaluation of Homeopathic Remedy (Cocculine®) Efficacy in the Management of Nausea After Adjuvant Chemotherapy in Non Metastatic Breast Cancer.

summary:
The purpose of the study is to determine whether a homeopathic remedy (Cocculine®) is effective in the prevention of chemotherapy-induced nausea in non metastatic breast cancer.

Eligible patients will be randomly assigned to one of 2-arms: Cocculine® or placebo.

The number of patients required to demonstrate a 0.5-point reduction in nausea on a visual analogue scale, assuming an alpha risk of 5% in a two-sided test and 85% power, is 396 (198 per arm). It has been estimated that the enrollment period should be 18 months.

ReferenceCitation: Pommier P, Gomez F, Sunyach MP, D'Hombres A, Carrie C, Montbarbon X. Phase III randomized trial of Calendula officinalis compared with trolamine for the prevention of acute dermatitis during irradiation for breast cancer. J Clin Oncol. 2004 Apr 15;22(8):1447-53.

ReferenceCitation: Pérol D, Provençal J, Hardy-Bessard AC, Coeffic D, Jacquin JP, Agostini C, Bachelot T, Guastalla JP, Pivot X, Martin JP, Bajard A, Ray-Coquard I. Can treatment with Cocculine improve the control of chemotherapy-induced emesis in early breast cancer patients? A randomized, multi-centered, double-blind, placebo-controlled Phase III trial. BMC Cancer. 2012 Dec 17;12:603. doi: 10.1186/1471-2407-12-603.


title: Neonatal Spinal Anesthesia: Effects of the Addition of Clonidine

summary: This prospective, double blinded study investigates spinal anesthesia with or without clonidine added to bupivacaine in newborns. This study is based on duration measurement of spinal anesthesia and cardio respiratory recording during 24h for apnea detection.

ReferenceCitation: Rochette A, Raux O, Troncin R, Dadure C, Verdier R, Capdevila X. Clonidine prolongs spinal anesthesia in newborns: a prospective dose-ranging study. Anesth Analg. 2004 Jan;98(1):56-59. doi: 10.1213/01.ANE.0000093229.17729.6C.

ReferenceCitation: Rochette A, Troncin R, Raux O, Dadure C, Lubrano JF, Barbotte E, Capdevila X. Clonidine added to bupivacaine in neonatal spinal anesthesia: a prospective comparison in 124 preterm and term infants. Paediatr Anaesth. 2005 Dec;15(12):1072-7.

lead_sponsor: University Hospital, Montpellier


title: Prospective Cohort Study on Patients With Tedizolid Prolonged Therapy for Orthopedic Device Infections

acronym: TEDIZOAM

summary: Pilot study the aim of which is to obtain reliable data on the tolerance, compliance and efficacy of Tedizolid used as prolonged (≥ 6 weeks) monotherapy or in combination therapy for the treatment of patients with orthopedic device infections due to Gram positive cocci.

ReferenceType: result

ReferenceCitation: Titécat M, Senneville E, Wallet F, Dezèque H, Migaud H, Courcol RJ, Loïez C. Microbiologic profile of Staphylococci isolated from osteoarticular infections: evolution over ten years. Surg Infect (Larchmt). 2015 Feb;16(1):77-83. doi: 10.1089/sur.2013.258. Epub 2015 Feb 4.

ReferenceCitation: Titécat M, Senneville E, Wallet F, Dezèque H, Migaud H, Courcol RJ, Loïez C. Bacterial epidemiology of osteoarticular infections in a referent center: 10-year study. Orthop Traumatol Surg Res. 2013 Oct;99(6):653-8. doi: 10.1016/j.otsr.2013.02.011. Epub 2013 Aug 27.

ReferenceCitation: Pulcini C, Couadau T, Bernard E, Lorthat-Jacob A, Bauer T, Cua E, Mondain V, Chichmanian RM, Dellamonica P, Roger PM. Adverse effects of parenteral antimicrobial therapy for chronic bone infections. Eur J Clin Microbiol Infect Dis. 2008 Dec;27(12):1227-32. doi: 10.1007/s10096-008-0570-y. Epub 2008 Sep 26.

ReferenceCitation: Spellberg B, Lipsky BA. Systemic antibiotic therapy for chronic osteomyelitis in adults. Clin Infect Dis. 2012 Feb 1;54(3):393-407. doi: 10.1093/cid/cir842. Epub 2011 Dec 12. Review.

ReferenceCitation: Morata L, Tornero E, Martínez-Pastor JC, García-Ramiro S, Mensa J, Soriano A. Clinical experience with linezolid for the treatment of orthopaedic implant infections. J Antimicrob Chemother. 2014 Sep;69 Suppl 1:i47-52. doi: 10.1093/jac/dku252. Review.

ReferenceCitation: Morata L, Senneville E, Bernard L, Nguyen S, Buzelé R, Druon J, Tornero E, Mensa J, Soriano A. A Retrospective Review of the Clinical Experience of Linezolid with or Without Rifampicin in Prosthetic Joint Infections Treated with Debridement and Implant Retention. Infect Dis Ther. 2014 Dec;3(2):235-43. doi: 10.1007/s40121-014-0032-z. Epub 2014 Aug 20.

ReferenceCitation: Senneville E, Legout L, Valette M, Yazdanpanah Y, Beltrand E, Caillaux M, Migaud H, Mouton Y. Effectiveness and tolerability of prolonged linezolid treatment for chronic osteomyelitis: a retrospective study. Clin Ther. 2006 Aug;28(8):1155-1163. doi: 10.1016/j.clinthera.2006.08.001.

ReferenceCitation: Senneville E, Legout L, Valette M, Yazdanpanah Y, Giraud F, Beltrand E, Obert G, Dubreuil L, Migaud H, Mouton Y. Risk factors for anaemia in patients on prolonged linezolid therapy for chronic osteomyelitis: a case-control study. J Antimicrob Chemother. 2004 Oct;54(4):798-802. Epub 2004 Aug 25.

ReferenceCitation: Legout L, Senneville E, Gomel JJ, Yazdanpanah Y, Mouton Y. Linezolid-induced neuropathy. Clin Infect Dis. 2004 Mar 1;38(5):767-8.

ReferenceCitation: Legout L, Valette M, Dezeque H, Nguyen S, Lemaire X, Loïez C, Caillaux M, Beltrand E, Dubreuil L, Yazdanpanah Y, Migaud H, Senneville E. Tolerability of prolonged linezolid therapy in bone and joint infection: protective effect of rifampicin on the occurrence of anaemia? J Antimicrob Chemother. 2010 Oct;65(10):2224-30. doi: 10.1093/jac/dkq281. Epub 2010 Jul 29.

ReferenceCitation: Betriu C, Morales G, Rodríguez-Avial I, Culebras E, Gómez M, López-Fabal F, Picazo JJ. Comparative activities of TR-700 (torezolid) against staphylococcal blood isolates collected in Spain. Antimicrob Agents Chemother. 2010 May;54(5):2212-5. doi: 10.1128/AAC.01653-09. Epub 2010 Feb 22.

ReferenceCitation: Douros A, Grabowski K, Stahlmann R. Drug-drug interactions and safety of linezolid, tedizolid, and other oxazolidinones. Expert Opin Drug Metab Toxicol. 2015;11(12):1849-59. doi: 10.1517/17425255.2015.1098617. Epub 2015 Oct 12. Review. Erratum in: Expert Opin Drug Metab Toxicol. 2015;11(12):v.

ReferenceCitation: Flanagan SD, Bien PA, Muñoz KA, Minassian SL, Prokocimer PG. Pharmacokinetics of tedizolid following oral administration: single and multiple dose, effect of food, and comparison of two solid forms of the prodrug. Pharmacotherapy. 2014 Mar;34(3):240-50. doi: 10.1002/phar.1337. Epub 2013 Aug 7.

ReferenceCitation: Flanagan S, McKee EE, Das D, Tulkens PM, Hosako H, Fiedler-Kelly J, Passarell J, Radovsky A, Prokocimer P. Nonclinical and pharmacokinetic assessments to evaluate the potential of tedizolid and linezolid to affect mitochondrial function. Antimicrob Agents Chemother. 2015 Jan;59(1):178-85. doi: 10.1128/AAC.03684-14. Epub 2014 Oct 20.

ReferenceCitation: Lodise TP, Bidell MR, Flanagan SD, Zasowski EJ, Minassian SL, Prokocimer P. Characterization of the haematological profile of 21 days of tedizolid in healthy subjects. J Antimicrob Chemother. 2016 Sep;71(9):2553-8. doi: 10.1093/jac/dkw206. Epub 2016 Jun 17.

ReferenceCitation: Schmidt-Malan SM, Greenwood Quaintance KE, Karau MJ, Patel R. In vitro activity of tedizolid against staphylococci isolated from prosthetic joint infections. Diagn Microbiol Infect Dis. 2016 May;85(1):77-9. doi: 10.1016/j.diagmicrobio.2016.01.008. Epub 2016 Jan 12.

ReferenceCitation: Morata L, Mensa J, Soriano A. New antibiotics against gram-positives: present and future indications. Curr Opin Pharmacol. 2015 Oct;24:45-51. doi: 10.1016/j.coph.2015.07.004. Epub 2015 Jul 30. Review. Erratum in: Curr Opin Pharmacol. 2015 Oct;24:147.

location_facility:
Hôpital Ambroise Paré
Hôpital de la Croix Rousse


title: Focus Sur l'Analyse de la récupération en oxymétries transcutanées (French Language)

acronym: FARO

summary: Analysis of localizations for symptoms and ischemia on treadmill and of the recovery profiles of patients that have had an exercise oximetry

study_type: Observational

time_perspective: Cross-Sectional

ipd_sharing: Undecided

ipd_sharing_description: Data available under reasonable request

lead_sponsor: University Hospital, Angers


title: French Database of Occipital Nerves Stimulation in the Treatment of Refractory Chronic Headache Disorders

acronym: NGO

summary:
The purpose of this non interventional research is to set up a French database, initially for 3 years, of patients suffering from refractory chronic headache disorders (chronic migraine, cluster headache, chronic paroxysmal hemicranias, SUNCT syndrome, hemicrania continua, cervicogenic headache disorders), and treated by occipital nerves stimulation.

Every team using this neuromodulation approach in France is likely to participate in the network.

Fifty patients a year are expected. They will be informed about data which are collected and why they are collected.

The data will come from medical files and questionnaires filling out by the patients. The data will be collected on a case report form adapted to each refractory chronic headache disorder. The case report form pages will be faxed to the coordinating team who will enter the data in the database and analyse the data in a descriptive manner.

These data are social and demographic data, medical data (headache features, headache functional and emotional impact, medications, and concomitant medical conditions), technical data (kind of electrodes and implantable pulse generator used, stimulation parameters chosen), and safety data.

This research should provide an update on practices, an evaluation of the efficacy and long term safety of occipital nerves stimulation, and perhaps help in identifying response predictive factors to this neuromodulation approach.

ReferenceCitation: Balossier A, Donnet A, Régis J, Leplus A, Lantéri-Minet M, Fontaine D. Occipital Nerve Stimulation for Recurrent Trigeminal Neuralgia Without Occipital Pain. Neuromodulation. 2022 Jun 7. pii: S1094-7159(22)00649-3. doi: 10.1016/j.neurom.2022.03.012. [Epub ahead of print]

ReferenceCitation: Fontaine D, Blond S, Lucas C, Regis J, Donnet A, Derrey S, Guegan-Massardier E, Jarraya B, Dang-Vu B, Bourdain F, Valade D, Roos C, Creach C, Chabardes S, Giraud P, Voirin J, Bloch J, Rocca A, Colnat-Coulbois S, Caire F, Roger C, Romettino S, Lanteri-Minet M. Occipital nerve stimulation improves the quality of life in medically-intractable chronic cluster headache: Results of an observational prospective study. Cephalalgia. 2017 Oct;37(12):1173-1179. doi: 10.1177/0333102416673206. Epub 2016 Oct 3.

lead_sponsor: Centre Hospitalier Universitaire de Nice

location_facility: Département d'Evaluation et Traitement de la Douleur


title: Efficacy and Safety of Somatropin in Combination With Leuprorelin Compared to Somatropin Alone in Pubertal Children With Idiopathic Short Stature

acronym: Phoenix

summary:
The present randomized trial was initially intended to study the benefits of a combined treatment with growth hormone (GH) and a gonadotropin-releasing hormone (GnRH) agonist for pubertal children with idiopathic short stature. However, treatments were stopped in January 2012 at the request of the French drug agency. Therefore, a protocol amendment divided the study in two study periods.

Study Period 1 involved combined treatment with somatropin and leuprorelin or treatment with somatropin alone. Participants from France who participated in this Period 1 of the study were asked to participate in a long term safety follow up defined as a Period 2 of the study. Participants from the Netherlands were offered participation in Genetics and Neuroendocrinology of Short Stature International Study (GeNeSIS, clinicaltrials.gov Identifier: NCT01088412) for long term safety follow up independent of this study.

ipd_sharing: Yes

ipd_sharing_description: Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement

lead_sponsor: Eli Lilly and Company

location_country: Netherlands France

location_facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.


title: Pilot Study on Interferon Gamma in Association With Peg-Interferon Alpha 2a and Ribavirin Among Patients With a Chronic Hepatitis C and Non Responders to the Association of Peg-Interferon Alpha 2b or 2a and Ribavirin ANRS HC16 Gammatri

summary: Viral hepatitis C is treated with peg-interferon alpha 2a/2b and ribavirin. There is no treatment recommended for non responders patients. This study will evaluate the efficacy, after a second treatment with peg-interferon alpha 2a and ribavirin for 12 Weeks of the addition of interferon gamma in non responders patients

ReferenceCitation: Couzigou P, Pérusat S, Bourlière M, Trimoulet P, Poynard T, Leroy V, Marcellin P, Foucher J, Bronowicki JP, Chêne G; ANRS HC16 GAMMATRI Trial Group. Interferon-gamma with peginterferon alpha-2a and ribavirin in nonresponder patients with chronic hepatitis C (ANRS HC16 GAMMATRI). J Gastroenterol Hepatol. 2013 Feb;28(2):329-34. doi: 10.1111/jgh.12060.

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

location_facility: Hopital Haut Leveque Service d'Hepato-Gastro-Enterologie


status: Active, not recruiting

acronym: BenraliScan

title: Computed Tomography Air-trapping Characterisation for the Early Identification of Benralizumab Responders Among Eosinophilic Asthma Patients

type: EudraCT Number

source: euctr

location_facility: Assistance Publique - Hopitaux de Marseille

summary:
BenraliScan aims to obtain thoracic computed tomography imaging data to predict the future level of patient response to a monoclonal antibody. Because the clinical responses under study can take many months to manifest, early identification of patients most-likely to benefit from treatment and treatment rule-out for others will save considerable time for everybody involved.

The primary objective of BenraliScan is to determine the prognostic value (sensitivity, specificity, positive predictive value, negative predictive value) of air-trapping measures (Expiratory/Inspiratory ratios for Mean Lung Density (MLDe/i)) detected via quantitative thoracic computed tomography at baseline for improvement in exacerbation rate (the presence of a ≥50% reduction in baseline exacerbation rate versus the absence of a ≥50% reduction in baseline exacerbation rate) at 52 weeks among eosinophilic asthma patients treated with Benralizumab.


title: Phase 2 Study Of The Anti-Angiogenesis Agent AG-013736 In Patients With Metastatic Melanoma

summary: This is a Phase 2 study being conducted at multiple centers in the United States and France. Patients having melanoma that has spread to other parts of the body (i.e., metastatic) are eligible to participate. Patients must have disease that has been treated with no more than 1 prior treatment for metastatic disease (prior adjuvant treatment for localized disease does not count as prior treatment for metastatic disease). The purpose of the study is to test whether the angiogenesis inhibitor AG-013736 is an effective treatment for metastatic melanoma as shown by the number of patients in the study who experience significant and durable tumor shrinkage.

lead_sponsor: Pfizer

location_country:
United States
France


title: Clinical Evaluation of LEft VEntricular Auto Threshold Algorithm

acronym: LEVEA

summary: The purpose of the LEVEA study is to assess the performances of a new automatic left ventricular auto threshold (LVAT) algorithm (In-Clinic LVAT algorithm) when used by physicians during in-hospital follow-up.

lead_sponsor: LivaNova


title: Effect of Intravenous Hydrocortison on Post-ischemic Brachial Artery Dilation and on Thenar Oxygen Saturation in Adult Septic Shock. A Human Placebo-controlled Randomized Study.

acronym: HyStOON

summary: The main objectives of the study are 1)to examine the immediate (2 hours) and delayed (8 hours) effects of intravenous hydrocortison on macro and microvascular post-ischemic vasoreactivity, in septic shock adult patients; 2) to examine possible correlations between post-ischemic flow-mediated dilation (FMD) of the brachial artery (assessed by ultrasound imaging) and post-ischemic recovery slope of the thenar oxygen saturation (StO2) (assessed by near-infrared spectroscopy).

lead_sponsor: Centre Hospitalier Régional d'Orléans


title: Comparison of the Efficacy of Micro-holes vs. Laser-assisted Dermabrasion, for Repigmenting in Vitiligo Skin

acronym: Dermabrasion

summary:
Principal objective: To compare the efficacy of laser-assisted dermabrasion + autologous epidermal cells suspension grafting versus dermabrasion using micro-needling technique + autologous epidermal cells suspension grafting and dermabrasion using micro-needling technique + placebo suspension grafting in stable vitiligo.

A total of 10 patients with stable non-segmental vitiligo will be included in the ITT population.

In each patient, three separate test areas will be selected in the same part of the body.

One area will be pre-treated with dermaroller and receive the hyaluronic acid suspension alone and the two others will receive the epidermal cell suspension in hyaluronic acid after pre-treatment either with dermaroller or laser-assisted dermabrasion, each patient being his own control.

Targeted phototherapy with excimer lamp (308 nMm) will be applied on all test areas 1 week after cell grafting.

location_facility:
CH Creteil
CHU de Bordeaux
CHU de Nice


title: Fluid Intake During Labour, Ultrasound Evaluation

acronym: EGTO

summary: We designed a two arms prospective, randomised, simple blinded trial to compare the impact of clear liquid intake on gastric content before delivery. We hypothesize that there will be no difference between the two groups, leading to safety of clear liquid intake during labour.

ReferenceCitation: Rousset J, Clariot S, Tounou F, Burey J, Hafiani EM, Féliot E, Quesnel C, Bonnet F, Fischler M. Oral fluid intake during the first stage of labour: A randomised trial. Eur J Anaesthesiol. 2020 Sep;37(9):810-817. doi: 10.1097/EJA.0000000000001278.

lead_sponsor: Hopital Foch

location_facility:
Hopital Foch
CHI Andre Gregoire
Tenon


title: Use of RDS MultiSense® in Post-ICU Patients in the COVID-19 Era

acronym: MONIREA

summary: In this clinical study, the investigators will compare vital parameters measurements obtained using continuous data from reference monitors and continuous wireless MultiSense® monitoring patch in 60 post-ICU (Intensive Care Unit) patients and over 7 days.

primary_purpose: Other

ReferenceCitation: Pamuk K, Turan N. The effect of light on sleep quality and physiological parameters in patients in the intensive care unit. Appl Nurs Res. 2022 Aug;66:151607. doi: 10.1016/j.apnr.2022.151607. Epub 2022 Jun 26.

lead_sponsor: IHU Strasbourg

location_facility: Anesthesia, Critical Care & Perioperative Medicine, Hautepierre


title: Primary-Pneumocystis Infection: Pneumocystis Jirovecii Detection in Nasopharyngeal Aspirates From Symptomatic Infants

acronym: CAPRI-PC

summary: To determine the prevalence of P. jirovecii in nasopharyngeal aspirations of neonates and infants hospitalized for symptomatic respiratory infection.

time_perspective: Prospective

lead_sponsor: University Hospital, Brest


title: ANRS HB 05 : A Randomized, Double Blind, Multicenter Study Evaluating Efficacy and Safety of Clevudine Monotherapy Versus Tenofovir Monotherapy Versus Combination Therapy of Clevudine and Tenofovir for 96 Weeks in HBeAg Negative Patients With Chronic Hepatitis B, naïve to Anti-VHB Therapy

summary: For chronic HBV infection, an optimal pharmacological agent to promote recovery from chronic HBV infection would be one that inhibits HBV DNA polymerase, combined with the clearence from the liver of cccDNA to block HBV reactivation after the circulating viral burden has been eliminated by therapy. The activity of clevudine on cccDNA in combination with its potent antiviral activity on HBV polymerase makes it the optimal agent in combination with tenofovir for this protocol.


title: Cohort Assessing the Immunogenicity and the Safety of the COVID-19 Vaccine Janssen in Healthy Volunteers Based on 2 Age Groups: 65 Years or Older - 55 to 65 Years. Covicompare-Janssen

lead_sponsor: Centre Hospitalier Universitaire de Saint Etienne

location_facility:
Hopital Bichat
Hopital Cochin
Centre Hospitalier Universitaire Nantes
Centre Hospitalier Regional Lille
Chu de Rouen
Centre Hospitalier de Saint-Etienne
Chu de Dijon
APHM
Centre Hospitalier Universitaire Rennes
Centre Hospitalier Tours

summary:
In response to the COVID-19 pandemic, several vaccines (Pfizer, Moderna, Astrazeneca, Janssen) have been developed and are being administered to millions of people in France and billions around the world through massive vaccination programs.

The Janssen vaccine is the fourth COVID-19 vaccine to be licensed in Europe. It received a European marketing authorization for all adults, without age limit, on March 11, 2021. Janssen's vaccine is a viral non replicating vector (adenovirus) vaccine targeting the Spike protein of the SARS-CoV-2 virus. It differs from currently available vaccines in that it is a single-dose regimen with significant protection at 28 days post-injection. Monitoring of the durability of the immune response is essential to assess the need for a booster vaccination. Insufficient data are available in the adult population regarding the evolution of the immune response. This point seems to be even more important in the elderly. Indeed, their immune system declines with age, leading to a greater susceptibility to infectious diseases and a weaker response to vaccination. This is called immunosenescence. Vaccination in this population is essential to avoid severe COVID-19 cases, since older people are particularly at risk.

Two CoviCompare studies with two licensed vaccines messenger RNA vaccines (Pfizer, Moderna) are underway to evaluate the immune response to each vaccine according to age.

We propose to conduct a study to evaluate the immunogenicity of the Janssen vaccine in different age groups with long-term follow-up. This will allow determining the need of a booster.

A common battery of in vitro and ex vivo immuno-monitoring tests has been set up to systematically assess the acquisition of humoral and cellular immunity over time over a period of 24 months following vaccination in the CoviCompare project. This trial, part of the CoviCompare project will use the same immunomonitoring set. This will also allow comparison of the immune response to different vaccines in subjects of different age in order to determine in this at risk population the better vaccination schedules.

The only difference between this trial and the other 2 trials of the CoviCompare project is that adults aged 18-45 will not be concerned here, because the adenovirus vaccine is not recommended for this age group in France


acronym: AJIBIOREM

title: Treatment Tapering in Oligoarticular or Rheumatoid Factor Negative Polyarticular Juvenile Idiopathic Arthritis With Inactive Disease on Biologic Therapy

lead_sponsor: Assistance Publique - Hôpitaux de Paris

summary: As biologic treatments are expensive and associated with some concerns regarding long-term safety, investigator hypothesize that early tapering and then withdrawal of biological agent, in an homogenous group of children with juvenile idiopathic arthritis achieving inactive disease, is safe and not inferior to the maintenance of stable treatment intensity over 24 weeks. In addition, investigator also hypothesize that an earlier tapering of treatment is associated with a better quality-of-life and a general cost saving effect. MRP8/14 will be studied as a potential biomarker for the risk of relapse. A study for biologic agent, anti-biologic agent antibodies and a pharmacogenomic approach will complete the research, as pharmacokinetic study during withdrawal of biologic treatment are rare in children.


title: A Multicenter Randomized Phase II Study Evaluating Tolerance and Efficacy of Capecitabine 5/7 Days With Weekly Paclitaxel Versus the Recommended Treatment Plan of Weekly Paclitaxel-capecitabine, in Patients With Metastatic Breast Cancer.

summary: Tolerance and efficacy of administration of capecitabine 5 out of 7 days associated with weekly paclitaxel compared to the recommended treatment plan of weekly paclitaxel - capecitabine, in patients with metastatic breast cancer.

lead_sponsor: ARCAGY/ GINECO GROUP


title: Reduction by Pasireotide of the Effluent Volume in High-output Enterostomy in Patients Refractory to Usual Medical Treatment : Phase II Multicentric Randomized Double Bland Placebo Controlled Study

acronym: SOMILEO

summary:
During rectal or complex digestive surgery with multiple digestive resections and anastomosis, the creation of enterostomy is a common procedure. In France, it is estimated that 20000 patients have an ileostomy and 16000 new digestive stomas are formed each year with approximately 30% of enterostomy. Enterostomy might sometimes give high-output not controlled with usual medical treatment (e.g loperamide ± codeine) and exposes the patients to important hydro-electrolytic loss leading to a risk for dehydration, electrolyte abnormalities and acute renal failure. This risk implies parenteral correction which may extend hospital stay and delay home return.

Somatostatin analogues (octreotide, lanreotide and pasireotide) could reduce digestive secretions and decrease digestive peristalsis. Nevertheless, somatostatin analogues are not routinely used for the treatment of patients with high-output enterostomy and their efficacy in the indication (off-label) was only tested in small case series. Pasireotide (SOM230, SIGNIFOR®) is currently indicated for the treatment of patients with Cushing's disease for whom surgery is not an option or for whom surgery has failed.

As the efficacity of pasireotide in patients with high-output enterostomy refractory to usual medical treatment associated with an oral fluid restriction has never been demonstrated before, there is a need to perform a pilot, double-blind, randomized, placebo-controlled trial evaluating its impact on reduction of the effluent volume.

lead_sponsor: Hospices Civils de Lyon

location_facility: Institut Regional Du Cancer Val D'Aurelle


acronym: Xeladys

title: Study of Efficacy and Acceptability of Tetrabenazine in the Late Dyskinetic Syndrome With Neuroleptics: A Randomized, Parallel Group, Double-blind Placebo Controlled Multicentre Trial

lead_sponsor: Centre Hospitalier Universitaire, Amiens

location_facility:
CHU Nantes
CHU Clermont-Ferrand
AP-HM Hopital de la Timone
CH des Charpennes
CHU Caen
CHU Poitiers
CHU Montpellier
CHU Rouen
CH Aix en Provence
CHU Bordeaux
CHU Saint Antoine
CHU Strasbourg
CHU Toulouse
CHU Limoges
CHU Nice
CHRU de Nimes
CHU Amiens
CHRU Lille
CHU de Rennes

summary:
Late dyskinetic syndrome with neuroleptics, or tardive dyskinesia, is the appearance of abnormal involuntary movements (AIM) in patients treated with antipsychotics for at least three months. This important public health issue arises for 15-20% of patients treated with neuroleptics, the most prescribed psychotropic drugs in mental disorders in France, and seriously impacts the patients' quality of life. In over 50% of cases, it is irreversible-that is to say that he will persist despite discontinuation of the offending drug.

Risk factors have been described: the age and female gender are established, a higher dosage of antipsychotic, a long-term treatment, a psychiatric condition other than schizophrenia are likely risk factors, intermittent treatment, previous acute dyskinesia, neuroleptics or powerful, longer term use of corrective treatments including anticholinergics are still discussed.

Apart from preventive treatment, which consists in using antipsychotics as being coerced, support is disappointing: the etiological treatment, which is to stop the offending antipsychotic, is effective only in less than 50% of cases, the syndrome is most often late irreversible. Must still have the possibility to interrupt the treatment, which is usually impossible in the risk of decompensation of the mental illness for which the neuroleptic was prescribed. Remains symptomatic treatment: functional neurosurgery is only for extreme cases, because it is not without risk, in terms of morbidity and mortality. So it's the medication that is most often offered: many drugs have been proposed, a direct result of the multiplicity of neurotransmitter systems implicated.

However, in the vast majority of cases, this approach is disappointing not to say ineffective. The only exception is the tetrabenazine, marketed under the name of Xenazine®. Empirically, neurologists specializing in pathology of the movement are almost unanimous: its efficiency is very good, with good tolerance. Some preliminary studies have reinforced this impression. However, their level of evidence remains low and that is why the investigators propose to implement a prospective multicenter clinical trial, double-blind with placebo which will include two groups of 27 patients.


title: Facilitate and Sustain Return to Work After Breast Cancer: Randomized Controlled Trial

acronym: FASTRACS-RCT

summary:
Breast cancer is the most frequent cancer in women in France, with an estimated 50,000 new cases each year. Prognosis is good, with a standardized survival rate of 85% at 5 years from diagnosis. Half of the women affected are of working age. Return to work after breast cancer faces barriers pertaining to the patients and their environment. There are social disparities in employment. Women with a lesser education and older women are at higher risk to lose their job. No intervention, to date, has demonstrated its effectiveness to facilitate return to work and reduce social disparities in employment after breast cancer. Current limitations of the interventions are to be over-medicalized and hospital-centered, to lack of theoretical foundations, and to be at risk of implementation failure. In a previous phase of the FASTRACS project, an intersectoral Community Advisory Board involving the different categories of stakeholders was launched to perform a needs analysis and build the logic model of the FASTRACS intervention with the Intervention Mapping protocol.

The main objective of the FASTRACS intervention is to facilitate sustained return to work (RTW) after breast cancer. Secondary objectives are to improve work-related quality of life and to decrease social disparities in employment after breast cancer.

Eligible patients are women: (1) aged between 18 and 55 years; (2) in paid employment; (3) diagnosed with a locally invasive non-metastatic first breast cancer (4) treated by surgery and chemotherapy in an adjuvant or neoadjuvant situation. Recruitment will take place in six investigating centres (centre hospitalier Lyon Sud, hôpital de la Croix-Rousse, hôpital femme-mère-enfant, centre Léon Bérard, hôpital Jean Mermoz, Clinique Charcot), after surgery and before the beginning of the chemotherapy. Women will be randomized between 2 groups (intervention vs control) with a stratification on the including centre, age, and socioprofessional category.

The intervention is founded on a multilevel logic model addressing the social determinants of health. It is composed of 4 successive steps during which 4 tools will be used. The first step involves an interview at the end of chemotherapy with a nurse, during which the patient is given a guide to returning to work. The second step is a transitional consultation in the month following the end of radiotherapy (or chemotherapy for patients without radiotherapy), with the general practitioner (GP), with a checklist designed to individualise the patient's care. The third step is a pre-RTW visit to the occupational physician (OP) at a time deemed appropriate by the patient and her GP, with a checklist to facilitate the accomodation of the workstation and the job retention strategy. The fourth and final step will only occur for patients who have not returned to work 10 months after inclusion, and will involve an interview with an OP specialised in return-to-work (RTW) coordination. The last tool is an employer's guide that will be given by the patient to her OP and her manager, with practical advice for managers and colleagues to facilitate the RTW process.

The evaluation of the intervention will be performed with mixed-methods by a realist randomized controlled trial including 210 patients in each group. For the effect evaluation, the primary outcome is a composite endpoint including: (a) a sustained return to work 12 months after oncological treatments (OT) ; and (b) the number of days on sick leave 12 months after oncological treatments. Secondary outcomes will include the patients' perspective (quality of life, anxiety, depression, RTW self-efficacy, social support, physical activity, work role functioning, work conditions), process outcomes (transition visit with the GP, pre RTW visit with the OP, other visits), and implementation outcomes (reach and use of the intervention tools).

Expected public health impact: Provided it is acceptable, effective and sustainable, the innovative intervention developed in this project is likely to decrease the impact of breast cancer on employment, and to decrease social disparities in employment after breast cancer. According to the mechanisms activated in each context under study (centres, workplaces), it could be scaled-up but also adapted to fit the needs of patients with other cancers or other chronic health conditions.

location_facility: Hopital de la croix rousse, Hospices Civils de Lyon

location_facility: Hopital Lyon sud, Hospices civils de Lyon

location_facility: Hopital femme mère enfant, Hospices Civils de Lyon

intervention_type: Behavioral


title: Preliminary Validation of the RC2S+ Therapy in Schizophrenia

summary:
Background:

Difficulties in social interactions are a central characteristic of people with schizophrenia, and can be partly explained by impairments of social cognitive processes. According to renown researchers, three to five social cognitive processes are usually altered in schizophrenia: (1) emotional processing; (2) theory of mind (ToM); (3) attributional style; and (4 and 5) social perception and knowledge. The components of social cognition appear to be related to both symptomatology and functioning in everyday life.

New strategies of cognitive remediation have been recently developed to target these deficits and few meta analyses have assessed the extent to which social cognitive remediation programs have led to multiple improvements for schizophrenia patients. Overall, it seems that such therapies showed encouraging results in both patient interest and motivation, and social cognitive processes.

The RC2S therapy is the first individualized and partly computerized program through which patients practice social interactions and develop social cognitive abilities with simulation techniques in a realistic environment.

lead_sponsor: Hôpital le Vinatier

location_facility: centre de réhabilitation - Hôpital le Vinatier


title: Describing, Detecting and Orienting Adults Without Intellectual Disability Asking for an Autism Spectrum Disorder Diagnosis

acronym: ASSORT

summary: The investigators aim at offering to about 80 patients a diagnostic assessment for Autism Spectrum Disorder (ASD), and at testing the feasibility of this protocol to detect and diagnose ASD in adults without intellectual disability.


title: Prospective Study of Total Knee Replacement With the ROCC Knee

summary: The purpose of this study was to assess the results of a Total Knee prosthesis specifically intended to enhance functional performance , especially in terms of physical and sports activity.

lead_sponsor: Bercovy, Michel, M.D.


title: Interest of Low-dose Landiolol Administration After Cardiac Surgery for the Prevention of Postoperative Atrial Fibrillation

acronym: LANDIPROTEC

summary:
Postoperative atrial fibrillation (POAF) is a common complication that occurs in 30-50% of patients after cardiac surgery and increases morbidity and mortality and hospital length of stay. During the perioperative period, the discontinuation of beta-blocker treatment is known to be a risk factor for developing POAF in patient undergoing cardiac surgery. Early beta-blocker reintroduction is associated with lower incidence of POAF. Unfortunately, side effects of currently available beta-blockers (including esmolol), such as low blood pressure and excessive bradycardia and/or their extended duration of action, limit their use in the post-operative period especially for prevention.

Landiolol, an ultra-short acting injectable beta-blocker, offers the advantage of significantly limiting low blood pressure events while increasing therapeutic efficacy in the treatment of POAF in cardiac and non-cardiac surgery. Landiolol, when used at low dose in the postoperative period, has been showed to reduce the incidence of POAF with no increased incidence of side effect as compared to standard of care. The limitation is that these promising data come from single center studies with limited samples and conducted exclusively in Japanese population. If landiolol is approved for use in the treatment of atrial fibrillation in non-Asian patients, there are no data on the prevention of POAF in cardiac surgery.

The objective of this multicenter, double-blind, randomized, placebo- controlled phase III trial is to confirm that landiolol postoperative infusion is associated with lower incidence of POAF without excess of adverse events as compared to standard of care in a non-Asian population after cardiac surgery with sternotomy.

lead_sponsor: CMC Ambroise Paré

location_facility:
Hôpital Privé Jacques Cartier
CMC Ambroise Paré


title: Investigation of the Safety, Tolerability and Pharmacodynamic Effects of Sublingual Immunotherapy Tablets of House Dust Mite Allergen Extracts in Adults With House Dust Mite-associated Allergic Asthma

summary: The purpose of this study is to investigate the safety of different doses of sublingual tablets of house dust mite allergen extracts in adults with house dust mite-associated allergic asthma.

lead_sponsor: Stallergenes Greer


title: Stress at Work and Infectious Risk in Patients and Caregivers

acronym: STRIPPS

summary:
In hospitals, the improvement of working conditions is often considered secondarily to patient satisfaction. Previous studies, showing statistically significant relationships, suggested the impact of hospital departments' organization (staff / patient ratio, bed distribution, caregiver's assignment), of the work environment, and the working conditions on the infectious risk at the hospital departments. In addition, organizational hospital constraints and the organization of care could equally have a major impact on the physical and psychological health of care workers (stress, fatigue, job satisfaction). To date, available data suggest that determinants of occupational stress and fatigue are multifactorial.

This research aims to develop an interdisciplinary approach to link two phenomena that are often studied independently while they are closely intertwined: working conditions and infectious risk in hospitals departments. Their main objective is to study the relationship between stress and caregiver fatigue at the work, organizational determinants and infectious risk for patients (healthcare-associated infections: HAIs) and for caregivers (blood exposure accidents: BEAs). The secondary objective is to analyze how the individual characteristics of the staff, the characteristics of their employment, and the overall organization in the hospital departments where they work interact to explain their physical and psychological state of health, on the one hand, and their behavior face to work (absenteeism, turnover and hand hygiene) on the other hand. The ultimate goal of this research is to be able to propose organizational strategies aimed at both reducing the probability of occurrence of healthcare-associated infections and preventing occupational risks for caregivers.


title: Adipose Tissue Involvement in Alcohol-induced Liver Inflammation in Human : Study of Pro- and Anti-inflammatory Cytokines and ADIPOKINES..

acronym: RIHTA

summary:
The histological characteristics of alcoholic liver disease (ALD) and non-alcoholic steatohepatitis (NASH) related to overweight and obesity suggest the presence of partly common physiopathological mechanisms. We reported that the ponderal overload was an independent risk factor of alcoholic cirrhosis. The adipose tissue was considered for a long time as a simple place of storage of fat. However, it is now recognized that the adipose tissue can secrete cytokines called ADIPOKINES.

The adipose tissue can secrete others cytokines such as TNF-alpha, IL6, IL10 and IL1-Ra. Increase in the production of the leptin and TNF-alpha by the adipose tissue after alcohol administration in the rat, as well as the role of leptin in inflammation and liver fibrogenesis in the murine model of chemical hepatotoxicity strongly suggest that activation of adipocytes by alcohol can explain the strong correlation observed between the body mass index (BMI) and the severity of ethanol-induced liver injury. Conversely, it was suggested in a murine model that the reduction in adiponectin production would sensitize the liver with the toxicity of alcohol. The PPAR alpha and gamma are the receptors which play a role both in inflammation and glucide and lipid metabolism. Taking into account the inhibiting role of PPAR alpha on the proliferation of the hepatic stellate cells, responsible for the fibrosis, the PPAR could also be implied in the relation between the overweight and the hepatic fibrosis in the alcoholic.

primary_purpose: Basic Science

ReferenceCitation: Voican CS, Njiké-Nakseu M, Boujedidi H, Barri-Ova N, Bouchet-Delbos L, Agostini H, Maitre S, Prévot S, Cassard-Doulcier AM, Naveau S, Perlemuter G. Alcohol withdrawal alleviates adipose tissue inflammation in patients with alcoholic liver disease. Liver Int. 2015 Mar;35(3):967-78. doi: 10.1111/liv.12575. Epub 2014 Jun 3.


title: Randomized Double Blind Trial Comparing the Efficacy of Prazosin Versus Placebo Associated With Peg-Interferon Alpha 2b and Ribavirin for Initial Treatment of Patients With Hepatitis C With Genotype 1 or 4 and Severe Fibrosis

summary: Viral hepatitis C prognosis is related to the presence of a fibrosis and to the risk of developing cirrhosis or hepatic cancer. The study will evaluate the efficacy of prazosin to make hepatic fibrosis regress, in patients with chronic hepatitis C and severe fibrosis.


title: Evaluation of Clinical and Biomechanical Correlation During Return to Sport After Anterior Cruciate Ligament Injury

acronym: REPILOG

summary:
Comparison of two groups of subjets (ACL injury who return to sport) and control group non-injured about clinical and biomechanical data :

clinical test
functional test
motion analysis of 2 sport exercises
tibial translation
isokinetic evaluation

ReferenceCitation: Granan LP, Bahr R, Steindal K, Furnes O, Engebretsen L. Development of a national cruciate ligament surgery registry: the Norwegian National Knee Ligament Registry. Am J Sports Med. 2008 Feb;36(2):308-15. Epub 2007 Nov 7.

ReferenceCitation: Olsen OE, Myklebust G, Engebretsen L, Bahr R. Injury mechanisms for anterior cruciate ligament injuries in team handball: a systematic video analysis. Am J Sports Med. 2004 Jun;32(4):1002-12.

ReferenceCitation: Herbst E, Hoser C, Hildebrandt C, Raschner C, Hepperger C, Pointner H, Fink C. Functional assessments for decision-making regarding return to sports following ACL reconstruction. Part II: clinical application of a new test battery. Knee Surg Sports Traumatol Arthrosc. 2015 May;23(5):1283-91. doi: 10.1007/s00167-015-3546-3. Epub 2015 Feb 28.

ReferenceCitation: Crawford SN, Waterman BR, Lubowitz JH. Long-term failure of anterior cruciate ligament reconstruction. Arthroscopy. 2013 Sep;29(9):1566-71. doi: 10.1016/j.arthro.2013.04.014. Epub 2013 Jun 29. Review.

ReferenceCitation: Webster KE, Feller JA, Leigh WB, Richmond AK. Younger patients are at increased risk for graft rupture and contralateral injury after anterior cruciate ligament reconstruction. Am J Sports Med. 2014 Mar;42(3):641-7. doi: 10.1177/0363546513517540. Epub 2014 Jan 22.

ReferenceCitation: Ford KR, Myer GD, Hewett TE. Valgus knee motion during landing in high school female and male basketball players. Med Sci Sports Exerc. 2003 Oct;35(10):1745-50.

ReferenceCitation: Hewett TE, Myer GD, Ford KR, Heidt RS Jr, Colosimo AJ, McLean SG, van den Bogert AJ, Paterno MV, Succop P. Biomechanical measures of neuromuscular control and valgus loading of the knee predict anterior cruciate ligament injury risk in female athletes: a prospective study. Am J Sports Med. 2005 Apr;33(4):492-501. Epub 2005 Feb 8.

ReferenceCitation: Paterno MV, Schmitt LC, Ford KR, Rauh MJ, Myer GD, Huang B, Hewett TE. Biomechanical measures during landing and postural stability predict second anterior cruciate ligament injury after anterior cruciate ligament reconstruction and return to sport. Am J Sports Med. 2010 Oct;38(10):1968-78. doi: 10.1177/0363546510376053. Epub 2010 Aug 11.


title: Late Versus Early Management of Gestational Diabetes Mellitus: a Non Inferiority Randomized Multicenter Trial

summary:
In 2010, the International Association of the Diabetes and Pregnancy Study Groups (IADPSG) panel published consensus-based recommendations on the diagnosis and classification of hyperglycemia in pregnancy. Cognizant that milder degrees of hyperglycemia would also be detected by early pregnancy testing, the IADPSG recommended that fasting plasma glucose (FPG) in the range of 5.1-6.9 mmol/l should be considered diagnostic of early Gestational Diabetes Mellitus (GDM) even if the level of proof for this recommendation is very low regarding to prognosis. This threshold was extrapolated from the FPG value used between 24 and 28 weeks.

In France, a FPG is proposed at the first prenatal visit for women with risk factors of GDM. Early GDM is diagnosed if FPG is ≥ 5.1 mmol/l, leading to an intensive metabolic management. Data have shown that GDM prevalence increased rapidly from 5.9% in 2009 to 9.3% in 2014. 26.9% of women with hyperglycemia during their pregnancy but without known diabetes are treated before 22 weeks' gestation (WG). More recent data from Italy and China, where IADPSG diagnosis criteria were applied, have strongly challenged this recommendation, and showed that early FPG ≥ 5.1mmo/L is poorly predictive of later GDM. No prior studies have demonstrated benefits to early screening and management. In 2016, the IADPSG members have suggested that the use of the FPG threshold ≥5.1 mmol/l for the identification of GDM in early pregnancy is not justified by current evidence

lead_sponsor: University Hospital, Lille

location_facility: Hopital Saint Vincent - Saint Antoine - Lille

location_facility: Csapa / Hus / Hopital Civil - Strasbourg

location_facility: Hopital Estaing - Chu63 - Clermont Ferrand


title: Impact of High-volume Veno-venous Continuous Hemofiltration in the Early Management of Septic Shock Patients With Acute Renal Failure

acronym: IVOIRE

summary: Sepsis and septic shock are still important causes of mortality in intensive care medicine. Renal replacement therapy by standard volume haemofiltration is currently used, but a higher-volume haemofiltration may improve the prognosis. The study is a prospective randomized multicenter trial comparing two treatments in patients suffering from septic shock complicated with acute renal failure admitted to ICU. One group will be treated by early high volume haemofiltration (70 ml/kg/h) and the second group by standard volume haemofiltration (35 ml/kg/h). The main outcome will be one-month mortality.

ReferenceCitation: Joannes-Boyau O, Honoré PM, Perez P, Bagshaw SM, Grand H, Canivet JL, Dewitte A, Flamens C, Pujol W, Grandoulier AS, Fleureau C, Jacobs R, Broux C, Floch H, Branchard O, Franck S, Rozé H, Collin V, Boer W, Calderon J, Gauche B, Spapen HD, Janvier G, Ouattara A. High-volume versus standard-volume haemofiltration for septic shock patients with acute kidney injury (IVOIRE study): a multicentre randomized controlled trial. Intensive Care Med. 2013 Sep;39(9):1535-46. doi: 10.1007/s00134-013-2967-z. Epub 2013 Jun 6.

lead_sponsor: University Hospital, Bordeaux

location_country: Netherlands France Belgium

location_facility: Service d'Anesthésie-Réanimation II, Groupe Hospitalier Sud, CHU de Bordeaux


title: Acoustic Structures Crying of Infants From 1 to 4 Months and Their Signification

acronym: LongCRY

summary:
Crying is a survival mechanism for babies and their almost exclusive means of expression until the age of 4 months. Babies 'cry is mostly related to pain, a feeling of hunger, discomfort or separation following the departure of a parent around. Crying is a complex but essential means of communication and information between a baby and his parents that raises the question of their meaning.

The cry phenomenon consists of complex acoustic signals produced by the vocal cords and filtered by the vocal tract. The vibrations frequency determines the fundamental frequency, itself responsible for the perception of the cry tone (pitch). The frequency spectrum of a cry is modified during the passage through the upper airways forming broad bands called "resonance frequency" or "formants".

From the specificity of a crying sequence, it is possible to extract dynamic information and relate it to the perception that the adult has of it. Thus dynamic crying is often perceived by the adult as an imminent need of the baby.

Some studies have shown that a child's crying may change according to his degree of discomfort, suggesting that crying was a "graduated signal" whose frequency and timbre could vary along a continuum. These changes would explain why adult listeners would be able to dissociate crying babies of different intensities.

Conversely, an inappropriate response to crying could gradually generate disorders of the relationship between the baby and the parent.

However, despite their potential neuro-ethological interest, knowledge of information transmitted by babies's cry remains superficial. This could be related to the relatively obsolete techniques of recording or due to the lack of objective physiological data on babies 'cry. Finally, the perception and reactions of adults when they hear crying babies are not fully understood.


title: High Flow Nasal Cannula Oxygen for Pre and During Procedure Oxygenation During Tracheal Intubation: Comparison With High FiO2 Non Rebreathing Bag Reservoir Facemasks

acronym: HAPI

summary: Tracheal intubation of critically ill patients is associated in the intensive care unit (ICU) with significant complications and morbidity. Patient desaturation is one of the most common complications that may lead to cardiac arrest despite pre-intubation oxygenation. Preoxygenation can be improved by the use of non-invasive ventilation, but this technique can be cumbersome to implement in the context of urgent intubation and more importantly it does not insure oxygenation during intubation. High flow nasal cannula oxygen therapy is a technique that has been shown to improve patient oxygenation in the context of acute hypoxemic respiratory failure. It bears the potential to be of clinical benefit in the setting of tracheal intubation in the ICU to ensure patient safety. The purpose of this study is to compare pre- and per-intubation (during intubation) oxygenation with either a conventional high FiO2 oxygen bag reservoir facemask (current standard practice) or high flow nasal cannula oxygen therapy (new practice to be implemented in our ICU).

ReferenceCitation: Sztrymf B, Messika J, Bertrand F, Hurel D, Leon R, Dreyfuss D, Ricard JD. Beneficial effects of humidified high flow nasal oxygen in critical care patients: a prospective pilot study. Intensive Care Med. 2011 Nov;37(11):1780-6. doi: 10.1007/s00134-011-2354-6. Epub 2011 Sep 27.

ReferenceCitation: Ricard JD. High flow nasal oxygen in acute respiratory failure. Minerva Anestesiol. 2012 Jul;78(7):836-41. Epub 2012 Apr 24. Review.

ReferenceCitation: Sztrymf B, Messika J, Mayot T, Lenglet H, Dreyfuss D, Ricard JD. Impact of high-flow nasal cannula oxygen therapy on intensive care unit patients with acute respiratory failure: a prospective observational study. J Crit Care. 2012 Jun;27(3):324.e9-13. doi: 10.1016/j.jcrc.2011.07.075. Epub 2011 Sep 29.

ReferenceCitation: Lenglet H, Sztrymf B, Leroy C, Brun P, Dreyfuss D, Ricard JD. Humidified high flow nasal oxygen during respiratory failure in the emergency department: feasibility and efficacy. Respir Care. 2012 Nov;57(11):1873-8. doi: 10.4187/respcare.01575. Epub 2012 Mar 13.

ReferenceCitation: Miguel-Montanes R, Hajage D, Messika J, Bertrand F, Gaudry S, Rafat C, Labbé V, Dufour N, Jean-Baptiste S, Bedet A, Dreyfuss D, Ricard JD. Use of high-flow nasal cannula oxygen therapy to prevent desaturation during tracheal intubation of intensive care patients with mild-to-moderate hypoxemia. Crit Care Med. 2015 Mar;43(3):574-83. doi: 10.1097/CCM.0000000000000743.

lead_sponsor: Hôpital Louis Mourier


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

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

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

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

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

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

study_start_date_type: Anticipated

status: Not yet recruiting

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

lead_sponsor: Centre Hospitalier Universitaire de Besancon

location_facility: Centre Hospitalier Universitaire de Rouen

location_facility: Clinique Chirurgicale De Saint Omer Blendecques

location_facility: Centre Hospitalier Universitaire de Grenoble

location_facility: Centre Hospitalier Universitaire de Bordeaux

location_facility: Centre Hospitalier Universitaire de Strasbourg

location_facility: Centre Hospitalier Universitaire de Lille

location_facility: Centre Hospitalier Universitaire de Besançon

location_facility: Centre Hospitalier Universitaire Amiens-Picardie


title: Leadless ECG Evaluation Study - Prospectively, Randomized, Cross-over, Multi-center, Interventional, Post-market Release Study to Evaluate the LECG System.

acronym: LECG

summary:
The leadless electrocardiogram (LECG) is a new technology incorporated into the Consulta CRT-P to obtain an ECG signal from the Consulta CRT-P similar to a surface ECG obtained from the device programmer (PECG) or an external ECG machine.

The purpose of the study is to obtain more data on leadless ECG to determine whether LECG during standard CRT follow-up can indeed adequately replace surface ECG and to evaluate if it can be used during remote follow-up evaluations.

ipd_sharing_description: No sharing

lead_sponsor: Medtronic Bakken Research Center


title: Efficacy and Safety of Ursodesoxycholic Acid in the Management of Non-Alcoholic Steatohepatitis

acronym: URSONASH

summary:
This is a phase II study with direct individual benefit. It is a randomized, double blind placebo controlled study whose aim is to evaluate the efficacy and tolerance of ursodesoxycholic acid in patients who have been diagnosed with non-alcoholic steatohepatitis.

The hepatoprotective effects of ursodesoxycholic acid may ameliorate the hepatic impairment associated with non-alcoholic steatohepatitis leading to subsequent significant decreases in transaminase elevations and non-invasive markers for hepatic fibrosis A positive response is defined as a significantly larger decrease in average ALAT levels between the time of inclusion in the study and the end of the treatment for the ursodesoxycholic acid group as compared to the placebo group.

The duration of the study will be 12 months. An end of treatment evaluation (EoT) will take place at the end of the 12th month of treatment.

lead_sponsor: Axcan Pharma


title: Central Neuromodulation of Pain Through Music in Healthy Subjects (DOUMU1)

summary: The present research aims to study the neuromodulatory effect of music on the sensory component of pain. The activation of pain control systems, through music, would pave the way for rehabilitation prospects for patients with a deficit of these controls.

ipd_sharing_description: All collected data that underlie results in a publication


title: Randomized Multicentric Double Blinded Study Evaluating CACICOL20 Efficiency Versus Placebo Corneal Chronic Ulcers Healing

acronym: UNICOL

summary:
CACICOL20 is a biodegradable nanopolymer engineered to mimic glycosaminoglycans such as heparan sulfates. Applied to the corneal lesion, it replaces damaged heparan sulfates in the matrix scaffold. CACICOL20 binds to matrix proteins such as collagen and cytokines or endogenous growth factors of the cellular microenvironment. CACICOL20 provides a protective function and restores the matrix architecture. This produces a suitable spatial environment for cells to respond properly to the cascade of signals needed for tissue regeneration to resume.

The ophthalmic solution, CACICOL20, used for corneal ulcers is very well tolerated both locally and generally, as proved by a pilot study which as been conducted at the "Hôpital des XV-XX" in Paris (France). It reduces the pain significantly and increases corneal ulcer healing (all ulcers treated were resistant to all other usual therapies).

Therefore, the accuracy of a Randomized multicentric double blinded study to evaluate the efficacy of CACICOL20 versus placebo for chronic corneal ulcer healing has been shown and will begin mid-may 2010. In this study, CACICOL20 will be applied every 2 or 4 days for 3 months.

The aim of the study is a double blinded comparison of complete chronic corneal ulcers healing rate within 3 months in 3 groups of patient double blinded randomized between CACICOL20 instillations distribution and physiological salt solution instillations distribution.

The main judgment criteria is healing rate within 3 months defined as corneal ulcer complete closure.

lead_sponsor: Organ, Tissue, Regeneration, Repair and Replacement

location_facility: Hôpital Gabriel Montpied - CHU Clermont Ferrand

location_facility: Centre Hospitalier Universitaire de Saint-Etiennne

location_facility: Centre Hospitalier Universitaire de Dijon

location_facility: Fondation Ophtalmologique Adolphe de Rothschild

location_facility: Centre Hospitalier Universitaire de Nantes

location_facility: Centre Hospitalier Universitaire de Tours


title: An Exploratory Study of the Feasibility of the Installation by a Paramedical Staff of a Standardized Meditation Technique "Body-scan", in the Management of Anxiety in Hospitalized Parkinsonian Patients

summary: The aim of the study is to constitute a proof of concept study for a larger study investigating the effect of mindfulness on anxiety and agitation in Parkinson's disease (PD) based on the results of a preliminary feasibility.

location_facility: Service de neurologie motricité,Hôpital Pellegrin